20FR12B
Table of Contents

As filed with the Securities and Exchange Commission on September 19, 2019

 

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 20-F

 

 

(Mark One)

 

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended                     

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                  to                 

OR

 

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report

Commission file number []

 

 

 

 

 

LOGO

Avita Medical Limited

(Exact name of Registrant as specified in its charter

and translation of Registrant’s name into English)

 

 

Australia

(Jurisdiction of incorporation or organization)

Level 7, 330 Collins Street

Melbourne VIC 3000 Australia

Tel: +61 (0) 3 8689 9997

Fax: +61 (0) 8 9474 7742

(Address of principal executive offices)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered
or to be registered

American Depositary Shares (each

representing 20 Ordinary Shares)

  CELS   The NASDAQ Stock Market LLC

Securities registered or to be registered pursuant to Section 12(g) of the Act. None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None

 

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

The number of ordinary shares, as of September 9, 2019 is 1,872,884,836

The number of American Depositary Shares, as of September 9, 2019 is 25,598,816

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ☐    No  ☒

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.    Yes  ☐    No  ☐

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☐    No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☐    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer  ☐                                        Accelerated filer  ☐                                         Non-accelerated filer     ☒
                                         Emerging  Growth Company     ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

 

    U.S. GAAP  ☐  

International Financial Reporting Standards as issued

by the International Accounting Standards Board  ☒

  Other  ☐

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.     Item 17  ☐    Item 18  ☐

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐    No  ☐

 

 

 


Table of Contents

TABLE OF CONTENTS

 

INTRODUCTION

     1  

PART I

     2  

Item 1.

  Identity of Directors, Senior Management and Advisers      2  

Item 2.

  Offer Statistics and Expected Timetable      2  

Item 3.

  Key Information      2  

Item 4.

  Information on the Company      22  

Item 4A.

  Unresolved Staff Comments      42  

Item 5.

  Operating and Financial Review and Prospects      42  

Item 6.

  Directors, Senior Management and Employees      53  

Item 7.

  Major Shareholders and Related Party Transactions      68  

Item 8.

  Financial Information      69  

Item 9.

  The Offer and Listing      71  

Item 10.

  Additional Information      73  

Item 11.

  Quantitative and Qualitative Disclosures About Market Risks      85  

Item 12.

  Description of Securities Other than Equity Securities      85  

PART II

     93  

Item 13.

  Defaults, Dividend Arrearages and Delinquencies      93  

Item 14.

  Material Modifications to the Rights of Security Holders and Use of Proceeds      93  

Item 15.

  Controls and Procedures      93  

Item 16

  Reserved      93  

Item 16A.

  Audit Committee Financial Expert      93  

Item 16B.

  Code of Ethics      93  

Item 16C.

  Principal Accountant Fees and Services      93  

Item 16D.

  Exemptions from the Listing Standards for Audit Committees      93  

Item 16E.

  Purchases of Equity Securities by the Issuer and Affiliated Purchasers      93  

Item 16F.

  Change in Registrant’s Certifying Accountant      93  

Item 16G.

  Corporate Governance      93  

Item 16H.

  Mine Safety Disclosure      94  

PART III

     95  

Item 17.

  Financial Statements      95  

Item 18.

  Financial Statements      95  

Item 19.

  Exhibits      95  

SIGNATURES

     97  

 

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INTRODUCTION

Avita Medical Limited was incorporated under the laws of the Commonwealth of Australia on December 21, 1992. The principal listing of our ordinary shares and to purchase our ordinary shares is the Australian Securities Exchange, or ASX. Our American Depositary Share (“ADS”) securities trade over the counter in the United States on the OTCQX market. We are filing this registration statement on Form 20-F in anticipation of the listing of our ADSs on the NASDAQ Capital Market under the symbol “CELS”. We have appointed Bank of New York Mellon to act as our American Depositary Share (“ADS”) registrar and transfer agent to register and deliver our ADS in the United States for the Nasdaq Stock Market. As used in this registration statement, the terms “we,” “us,” “our,” “Avita,” and the “Company” mean Avita Medical Limited and its subsidiaries, unless otherwise indicated.

Our consolidated financial statements appearing in this registration statement on Form 20-F are prepared in Australian dollars and in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this registration statement on Form 20-F comply with IFRS.

In this registration statement, all references to “U.S. dollars” or “US$” are to the currency of the United States of America, and all references to “Australian dollars” or “A$” are to the currency of Australia.

Statements made in this registration statement on Form 20-F concerning the contents of any contract, agreement or other documents are summaries of such contracts, agreements or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this registration statement or to any registration statement or annual report that we previously filed, you may read the document itself for a complete description of its terms.

Except for the historical information contained in this registration statement on Form 20-F, the statements contained in this registration statement on Form 20-F are “forward-looking statements” which reflect our current view with respect to future events and financial results. We urge you to consider that statements which use the terms “anticipate,” “believe,” “do not believe,” “expect,” “plan,” “intend,” “estimate,” and similar expressions are intended to identify forward-looking statements. We remind investors that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements expressed or implied by such forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly release any update or revision to any forward-looking statements to reflect new information, future events or circumstances, or otherwise after the date hereof. Please see the Risk Factors section that appears in “Item 3. Key Information – D. Risk Factors.”

 

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PART I

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

A. Directors and Senior Management

For the names, business addresses and functions of our directors and senior management, see “Item 6. Directors, Senior Management and Employees – A. Directors and Senior Management” and “Item 6. Directors, Senior Management and Employees – C. Board Practices.”

B. Advisers

Our principal legal adviser is K&L Gates LLP, 925 Fourth Avenue, Suite 2900, Seattle, Washington 98104, United States of America and 25/525 Collins St, Melbourne VIC 3000, Australia.

C. Auditors

Our statutory auditor for Australia and U.S. reporting purposes is Grant Thornton Audit Pty Ltd Level 43 Central Park, 152-158 St Georges Terrace Perth, WA 6000 Australia.

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable.

ITEM 3. KEY INFORMATION

A. Selected Financial Data

Our consolidated financial statements appearing in this registration statement on Form 20-F are prepared in Australia dollars in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this registration statement on Form 20-F comply with IFRS.

The following table summarizes our historical consolidated financial data and should be read together with our consolidated financial statements, the notes to our consolidated financial statements and the sections titled “Selected consolidated financial data” and “Management’s discussion and analysis of financial condition and results of operations” contained elsewhere in this Registration Statement on Form 20-F.

 

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We derived the summary consolidated statements of profit or loss or other comprehensive income data and consolidated statements of financial position data for the fiscal years ended June 30, 2018, 2017 and 2016 from our audited consolidated financial statements included elsewhere in this Registration Statement on Form 20-F. We have derived the unaudited condensed consolidated statements of profit or loss or other comprehensive income for the half-year ended December 31, 2018 and 2017, and the unaudited condensed consolidated statement of financial position data as of December 31, 2018, from our unaudited condensed consolidated financial statements, included elsewhere in this Registration Statement. We have prepared the unaudited financial information on a basis consistent with our audited consolidated financial statements and have included, in our opinion, all adjustments, consisting only of normal recurring adjustments, that we consider necessary for a fair statement of the financial information set forth in those statements. The summary financial data included in this section are not intended to replace the financial statements and related notes included elsewhere in this Registration Statement. Our historical results are not necessarily indicative of our future performance, and our interim results are not necessarily indicative of the results to be expected for the full fiscal year.

 

    Years ended June 30,     Half-year ended December 31,  

(In Australian dollars)

  2018     2017     2016     2018     2017  

Consolidated statements of profit or loss or other comprehensive income:

         

Sale of goods

  A$ 1,198,861     A$ 901,376     A$ 1,002,007     A$ 1,813,195     A$ 607,761  

Cost of sales

    (511,646     (463,285     (401,568     (570,315     (264,833
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

    687,215       438,091       600,439       1,242,880       342,928  

BARDA income

    10,104,081       6,886,236       2,424,357       5,009,137       3,856,716  

Other income

    68,617       344,734       120,160       103,626       37,595  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other income

    10,172,698       7,230,970       2,544,517       5,112,763       3,894,311  

Operating costs

         

Sales and marketing expenses

    (8,936,441     (5,201,761     (5,042,189     (6,931,241     (2,815,698

Product development expenses

    (12,606,127     (11,161,970     (6,018,184     (7,080,042     (5,058,518

Corporate and administrative expenses

    (5,360,553     (2,264,594     (2,371,747     (6,865,250     (2,873,511

Share-based payment expenses

    (1,835,157     (1,587,243     (956,658     (1,043,694     (726,856

Finance costs

    (26,586     (12,754     (21     (14,807     (13,253
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating costs

    (28,764,864     (20,228,322     (14,388,799     (21,935,034     (11,487,836
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss from continuing operations before income tax benefit

    (17,904,951     (12,559,261     (11,243,843     (15,579,391     (7,250,597

Profit for the period from discontinued operations

    —         —         2,493,947       —         —    

Income tax benefit

    1,385,796       1,048,237       971,881       —         —    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

    (16,519,155     (11,511,024     (7,778,015     (15,579,391     (7,250,597

Other comprehensive income (loss)

         

Foreign currency translation

    563,279       (83,293     (169,100     1,374,144       (55,390

Fair value gain (loss) on available for sale financial assets

    —         (265,261     265,261       —         —    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss) for the period, net of tax

    563,279       (348,554     96,161       1,374,144       (55,390
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total other comprehensive loss for the period

  A$ (15,955,876   A$ (11,859,578   A$ (7,681,854   A$ (14,205,247   A$ (7,305,987
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Earnings per share

         

Basic and diluted loss per share from continuing operations

  A$ (1.77) cents     A$ (1.72) cents     A$ (1.56) cents     A$ (1.59) cents     A$ (0.91) cents  

Basic and diluted loss per share from discontinued operations

    —         —       A$ (0.05) cents       —         —    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

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    As of June 30,     As of December 31,  

(In Australian dollars)

  2018     2017     2016     2018  

Consolidated statements of financial position data:

       

Cash and cash equivalents

  A$ 14,825,532     A$ 3,790,491     A$ 4,171,879     A$ 30,342,360  

Total current assets

    22,274,431       7,280,541       8,508,418       34,953,776  

Total assets

    23,017,014       7,667,921       8,602,909       36,347,382  

Total current liabilities

    3,883,117       2,546,089       1,750,392       5,017,066  

Total equity

    18,999,559       5,121,832       6,852,517       31,247,284  
 

 

 

   

 

 

   

 

 

   

 

 

 

Exhibit 15.1 included with this registration statement on Form 20-F contains the preliminary, unaudited consolidated statements of profits or loss and other comprehensive income, consolidated statements of financial position, consolidated statements of cash flows and consolidated statements of changes in equity for the fiscal year ended June 30, 2019 as submitted as Appendix 4E in connection with the ongoing listing of our ordinary shares on the Australian Securities Exchange. The results presented in Exhibit 15.1 are preliminary in nature, have not been audited, and are subject to change and should not be relied on as indicative of actual results for the year ended June 30, 2019.

Exchange Rate Information

We publish our consolidated financial statements in Australian dollars. In this Registration Statement, references to dollars, “$” or “A$” are to Australian dollars currency and references to “U.S. dollars” or “US$” are to U.S. currency. Solely for informational purposes, this Registration Statement contains translations of certain Australian dollars into or from U.S. dollars at specified rates. These translations should not be construed as representations that the Australian dollars amounts actually represent such U.S. dollar amounts or could be converted into or from U.S. dollars at the rate indicated or at any other rate. Unless otherwise stated herein, the translations of Australian dollars into or from U.S. dollars have been made at A$1.00 to US$0.7399, the Buying Rate on June 30, 2018.

The following tables set forth, for the periods and dates indicated, certain information regarding the rates of exchange of A$1.00 into US$ based on rates published by the Reserve Bank of Australia (RBA). Each period end rate is the average ask price for the day. The average rate is the average of all the ask prices for the given time period. The high rate is the highest bid rate for the given time period. The low rate is the lowest bid rate for the given time period. We make no representation that any Australian dollar or U.S. dollar amounts could have been or could be, converted into U.S. dollars or Australian dollars, as the case may be, at any particular rate, the rates stated below, or at all.

The Australian dollar is convertible into U.S. dollars at freely floating rates. There are no legal restrictions on the flow of Australian dollars between Australia and the U.S.

 

Year

Ended June 30,

 

At Period End

 

Average Ratio

 

High

 

Low

2014

  A$0.9420   A$0.9187   A$0.9672   A$0.8716

2015

  A$0.7680   A$0.8382   A$0.9452   A$0.7590

2016

  A$0.7426   A$0.7283   A$0.7812   A$0.6867

2017

  A$0.7692   A$0.7545   A$0.7724   A$0.7202

2018

  A$0.7399   A$0.7753   A$0.8105   A$0.7355
       

 

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Month

   High      Low  

July 2018

   A$ 0.7467      A$ 0.7360  

August 2018

   A$ 0.7441      A$ 0.7213  

September 2018

   A$ 0.7296      A$ 0.7103  

October 2018

   A$ 0.7200      A$ 0.7034  

November 2018

   A$ 0.7316      A$ 0.7130  

December 2018

   A$ 0.7375      A$ 0.7051  

January 2019

   A$ 0.7268      A$ 0.6945  

February 2019

   A$ 0.7260      A$ 0.7072  

March 2019

   A$ 0.7145      A$ 0.7009  

April 2019

   A$ 0.7200      A$ 0.7025  

B. Capitalization and Indebtedness

The table below sets forth our total indebtedness and shows our capitalization as of June 30, 2018. You should read this table in conjunction with our consolidated financial statements included in this Registration Statement on Form 20-F, together with the accompanying notes and the other information appearing under the heading “Item 5. Operating and Financial Review and Prospects”.

 

     As of June 30, 2018
(In Australian Dollars)
 

Cash and cash equivalents

   A$ 14,825,532  
  

 

 

 

Long-term debt

   A$ —    
  

 

 

 

Contributed equity

     162,801,028  

Accumulated losses

     (148,592,879

Reserves

     4,791,410  
  

 

 

 

Total

     18,999,559  

Total capitalization

   A$ 18,999,559  
  

 

 

 

C. Reasons for the Offer and Use of Proceeds

Not applicable.

D. Risk Factors

Our business faces significant risks. You should carefully consider all of the information set forth in this registration statement, including the following risk factors. Our business, results of operations, and financial condition could be materially and adversely affected by any of these risks, and in such event, the trading price of our ordinary shares, which underlie our ADSs, would likely decline and you might lose all or part of your investment. This registration statement also contains forward-looking statements that involve risks and uncertainties and our results could materially differ from those anticipated in these forward-looking statements. See “Special Note Regarding Forward-Looking Statements” at the beginning of Item 5.

Risks Related to Our Business

We have experienced significant losses, expect losses to continue for the foreseeable future and may never achieve or maintain profitability.

Although we have begun full scale marketing and sales of our RECELL System in the U.S. and other jurisdictions, such sales have been limited to date and we have not yet obtained profitability. We had a total comprehensive loss of A$16,519,155, A$11,511,024 and A$7,778,015 for our fiscal years ended June 30, 2018,

 

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2017 and 2016, respectively. We have incurred a cumulative deficit of A$148,592,879 through June 30, 2018. We anticipate that we may continue to incur losses at least until margins from U.S. sales of the RECELL System are adequate to fund operating expenses. We may not be able to successfully achieve or sustain profitability. Successful transition to profitable operations is dependent upon achieving a level of revenues adequate to support our cost structure.

We may be unsuccessful in obtaining additional approvals for our RECELL System for the treatment of pediatric burns, trauma wounds and skin conditions such as vitiligo.

Although our Premarket Approval (PMA) application for the RECELL System was approved by the U.S. Food and Drug Administration (FDA) for use the treatment of acute thermal burn wounds in patients 18 years and older in September 2018, it has not been approved for additional indications such as pediatric burns or trauma wounds, or for the treatment of vitiligo. We plan to expand into each of these indications and will need to apply for a supplement to our PMA approval with the FDA in connection with each proposed additional indication. While clinical trials for such uses are presently underway or planned, there can be no assurance that we will ever receive approval by the FDA for the use of our RECELL System for such additional applications. Such a failure of approval would have a material negative effect to our future prospects.

We are dependent on our contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA), and if we do not continue to receive funding under this contract, we may need to obtain alternative sources of funding.

We have a contract with BARDA valued currently at US$50.4 million (approximately A$68.1 million) related to funding for the development of the RECELL System and future use of the product to assist disaster preparedness and response in the U.S. for mass casualties involving burn victims. As of December 31, 2018, we had received cumulative payments of US$17.18 million (A$22.6 million) under the BARDA contract. Under the contract BARDA has agreed to fund and provide technical support for the development of the RECELL System including two randomized, controlled pivotal clinical trials, Compassionate Use and Continued Access programs, development of the health economic model demonstrating the cost savings associated with the RECELL System, and two randomized, controlled clinical trials in pediatric burn patients. Also included in the BARDA contract is a provision for the future procurement of the RECELL System by BARDA under a vendor-managed inventory system to bolster disaster preparedness. There can be no assurances that BARDA will not terminate the contract and changes in government agenda and annual budgets may result in changing priorities and funding mandates at BARDA. Any reduction or delay in BARDA funding may force us to seek alternative funding, which may not be available on non-dilutive terms, terms favorable to us or at all, or cease our development programs related to the BARDA contract.

Development and commercialization of any products requires successful completion of the regulatory approval process and may suffer delays or fail.

In the U.S., as well as other jurisdictions, we have been and will be required to apply for and receive regulatory authorization before we can market our products. Although our RECELL System has been approved for use in the treatment of acute thermal burn wounds in patients 18 years and older in the U.S., we will have to apply for a supplement to our PMA approval to market the product for use in the treatment of pediatric burns, trauma injuries and vitiligo. In China and Australia, the RECELL System is approved use for the treatment of burns, acute wounds, scars and vitiligo. In Europe the product has been approved for the treatment of burns, chronic wounds, scars and vitiligo. We will require additional approvals from regulatory authorities within these countries to market the product for the treatment of other indications, and from any other jurisdictions in which we seek to market the product. This process can be time consuming and complicated and may result in unanticipated delays or fail altogether. To secure marketing authorization, an applicant generally is required to submit an application that includes the data supporting preclinical and clinical safety and effectiveness as well as detailed information on the manufacturing and control of the product, proposed labeling and other additional

 

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information. Before marketing authorization is granted, regulatory authorities may require the inspection of the manufacturing facility or facilities and quality systems (including those of third parties) at which the product candidate is manufactured and tested, as well as potential audits of the non-clinical and clinical trial sites that generated the data cited in the marketing authorization application.

We cannot predict whether any additional marketing authorizations will ultimately be granted or how long the applicable regulatory authority or agency will take to do so. Regulatory agencies, including the FDA, have substantial discretion in the approval process. In addition, the approval process and the requirements governing clinical trials vary from country to country. The policies of the FDA or other regulatory authorities may change, and additional government regulations may be enacted that could prevent, limit or delay the necessary approval of any products we may develop and commercialize. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or elsewhere. If we are slow or unable to adapt to new or changed requirements, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

Additionally, any future regulatory approvals that we receive may also contain requirements for costly post-marketing testing and surveillance to monitor the safety and effectiveness of the product. Once a product is approved, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. These requirements include submission of safety and other post-marketing reports, registration and continued compliance with good manufacturing practices for any clinical trials that we conduct post-approval.

Obtaining and maintaining regulatory approval for a product candidate in one jurisdiction does not mean that we will be successful in obtaining regulatory approval for that product candidate in other jurisdictions.

Obtaining and maintaining regulatory approval for a product in one jurisdiction does not guarantee that we will be able to obtain or maintain similar approval in other jurisdictions, while a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants marketing approval for use of our RECELL System for the treatment of pediatric burns, trauma injuries and/or vitiligo, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries if not currently approved today. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the U.S., including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a medical device must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to approval.

We may encounter substantial delays in any further clinical studies necessary to support any regulatory applications for additional commercial applications of our technology.

We cannot guarantee that any preclinical testing or clinical trials will be conducted as planned or completed on schedule, if at all. As a result, we may not achieve the expected clinical milestones necessary for approval by the FDA, or other regulators, for the use of our RECELL System for additional applications in the United States or other countries.

A failure can occur at any stage of testing. Events that may prevent successful or timely commencement, enrollment or completion of clinical development include:

 

   

delays in raising, or inability to raise, sufficient capital to fund the planned trials;

 

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delays in reaching a consensus with regulatory agencies on trial design;

 

   

changes in trial design;

 

   

inability to identify, recruit and train suitable clinical investigators;

 

   

inability to add new clinical trial sites;

 

   

delays in reaching agreement on acceptable terms for the performance of the trials with prospective clinical research organizations and clinical trial sites;

 

   

delays in recruiting suitable clinical sites and patients (i.e., subjects) to participate in clinical trials;

 

   

imposition of a clinical hold by regulatory agencies for any reason, including negative clinical results, safety concerns or as a result of an inspection of manufacturing or clinical operations or trial sites;

 

   

failure by any relevant parties to adhere to clinical trial requirements;

 

   

failure to perform in accordance with the FDA’s current Good Clinical Practices, or cGCP, or applicable regulatory guidelines in other countries;

 

   

delays in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites;

 

   

delays caused by clinical trial sites not completing a trial;

 

   

failure to demonstrate adequate effectiveness;

 

   

occurrence of serious adverse events in clinical trials that are associated with the product candidates that are viewed to outweigh its potential benefits;

 

   

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; or

 

   

disagreements with regulatory agencies in the interpretation of the data from our clinical trials.

Delays, including delays caused by the above factors, can be costly and could negatively affect our ability to complete clinical trials for our product candidates. If we are not able to successfully complete clinical trials or are not able to do so in a timely and cost-effective manner, we will not be able to obtain regulatory approval for the use of our RECELL System for additional applications, all of which could have a material adverse effect on our business, financial condition and results of operations.

We may be unsuccessful in commercializing our RECELL System, or other future products, due to unfavorable pricing regulations or third-party coverage and reimbursement policies.

We cannot guarantee that we will receive favorable pricing and reimbursement for use of our products. The rules and regulations that govern pricing and reimbursement for medical products vary widely from country to country or from indication to indication, and within the U.S. can also vary widely from one health system or hospital to the next. In some foreign jurisdictions, including the European Union, the government largely controls pricing of medical products. In other countries, coverage negotiations must occur at the regional or hospital level. Pricing negotiations can take considerable time after the receipt of marketing approval for a medical product.

As a result, even after obtaining regulatory approval for a product in a particular country, we may be subject to price regulations or limited reimbursement, which may delay or limit our commercial launch of the product and negatively impact the revenue we are able to generate from the sale of the product in that country. Adverse pricing limitations may hinder our ability to recoup our total investment in our RECELL System or other future products, even after obtaining regulatory approval.

If we are unable to promptly obtain coverage and profitable payment rates from hospital budget, government-funded and private purchasers for the RECELL System or any future products, this could have a

 

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material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

We have limited financial resources and will likely require additional financings to continue the development and commercialization of our RECELL System or any future products, which may cause dilution to our existing shareholders or place restrictions on our operations. If additional financing is not available, we may have to postpone, reduce or cease operations.

If we are unable to achieve profitability sufficient to permit us to fund our operations and other planned actions, we may be required to raise additional capital. There can be no assurance that such capital would be available on favorable terms, or at all. If we raise additional capital through the issuance of equity or convertible debt securities, the percentage ownership held by existing shareholders may be reduced, and the market price of our ordinary shares which underlie our ADSs could fall due to an increased number of shares available for sale in the market. Debt financing, if available, may involve restrictive covenants, which may limit our operating flexibility with respect to certain business matters. If we are unable to secure additional capital as circumstances require, we may not be able to fund our planned activities or continue our operations.

We have limited experience manufacturing our products in large-scale commercial quantities and we may face manufacturing risks that may adversely affect our ability to manufacture products and could reduce our gross margins and negatively affect our business and operating results.

Our success depends, in part, on our ability to manufacture our current and future products in sufficient quantities and on a timely basis to meet demand, while adhering to product quality standards, complying with regulatory quality system requirements and managing manufacturing costs. We have a manufacturing facility located in Ventura, California where we produce, package and warehouse the RECELL System. We also rely on global third-party manufacturers, Baxter International Inc., Hospira (a division of Pfizer), Thermo Fisher Scientific, Lyophilization Services of New England and Becton Dickinson and Company, for production of some of the components used in the RECELL System. If our facility, or the facilities of our third-party contract manufacturers, suffers damage, or a force majeure event, this could materially impact our ability to operate.

We are also subject to other risks relating to our manufacturing capabilities, including:

 

   

Quality and reliability of components, sub-assemblies and materials that we source from third-party suppliers, who are required to meet our quality specifications, some of whom are our single-source suppliers for the products they supply;

 

   

failure to secure raw materials, components and materials in a timely manner, in sufficient quantities or on commercially reasonable terms;

 

   

inability to secure raw materials, components and materials of sufficient quality to meet the exacting needs of medical device manufacturing;

 

   

failure to maintain compliance with quality system requirements or pass regulatory quality inspections;

 

   

inability to increase production capacity or volumes to meet demand; and

 

   

inability to design or modify production processes to enable us to produce future products efficiently or implement changes in current products in response to design or regulatory requirements.

These risks could be exacerbated by our limited experience as an entity with large-scale commercial manufacturing. As demand for our products increases, we will have to invest additional resources to purchase raw materials and components, sub-assemblies and materials, hire and train employees and enhance our manufacturing processes. If we fail to increase our production capacity efficiently to meet demand for our products, we may not be able to fill customer orders on a timely basis, our sales may not increase in line with our expectations and our operating margins could fluctuate or decline. It may not be possible for us to manufacture

 

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our products at a cost or in quantities sufficient to make these products commercially viable or to maintain current operating margins, all of which could have a material adverse effect on our business, financial condition and results of operations. In addition, the Company is continually identifying additional third-party manufacturers who could serve if necessary as replacement manufacturers should the need arise.

We rely on third parties to conduct, supervise and monitor our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our drug product candidates and our business could be substantially harmed.

We rely on clinical research organizations, or CROs, and clinical trial sites to ensure our clinical trials are conducted properly and on time. While we will have agreements governing their activities, we will have limited influence over their actual performance. CROs manage and monitor the clinical trials, duties and functions, and we will control only certain aspects of our CROs’ activities. Nevertheless, we will be responsible for ensuring that each of our clinical trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

We and our CROs are required to comply with the FDA’s Good Clinical Practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. The FDA, and comparable foreign regulatory authorities, enforce these GCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites. If we or our CROs fail to comply with applicable GCPs, the clinical data generated in our future clinical trials may be deemed unreliable and the FDA or other foreign regulatory authorities may require us to perform additional clinical trials before approving any marketing applications.

If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements, or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize, our product candidates. If any such event were to occur, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase, and our ability to generate revenues could be delayed. If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially reasonable terms. Further, switching or adding additional CROs involves additional costs and requires management time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which could materially impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

Product recalls or inventory losses caused by unforeseen events may adversely affect our operating results and financial condition.

Our products are manufactured, stored and distributed using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. The complexity of these processes, as well as strict company and government standards for the manufacture, storage and distribution of our product candidates, subjects us to risks. In addition, process deviations or unanticipated effects of approved process changes may result in production runs of our RECELL System not complying with stability requirements or specifications. The occurrence or suspected occurrence of production and distribution difficulties can lead to lost inventories and in some cases product recalls, with consequential reputational damage and the risk of product liability. The investigation and remediation of any identified problems can cause production delays, substantial expense, lost sales and delays of new product launches. In the event our production efforts require a recall or result in an inventory loss, our operating results and financial condition may be adversely affected.

 

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If we fail to manage our growth effectively, our business could be disrupted.

Our future financial performance and ability to successfully commercialize our products, which is not guaranteed, and to compete in the market will depend, in part, on our ability to manage any future growth effectively. We expect to make significant investments to facilitate our future growth through, among other things:

 

   

new product development;

 

   

clinical development of our RECELL System to such areas as pediatric burns, trauma injuries and vitiligo;

 

   

clinical trials for additional indications; and

 

   

funding of our marketing and sales infrastructure.

Any failure to manage future growth effectively could have a material adverse effect on our business and results of operations.

Our growth and success depend on our ability to attract and retain additional highly qualified and skilled sales and marketing, research and development, operational, managerial and finance personnel.

Competition for skilled personnel is intense and the unexpected loss of an employee with a particular skill could have a material adverse effect on our operations until a replacement can be found and trained. If we cannot attract and retain skilled scientific and operational personnel for our research and development and manufacturing operations on acceptable terms, we may not be able to develop and commercialize our products. Further, any failure to effectively integrate new personnel could prevent us from successfully growing our company.

We currently report our financial results under IFRS, which differs in certain significant respects from U.S. GAAP.

Currently we report our financial statements under IFRS. There have been and there may in the future be certain significant differences between IFRS and Generally Accepted Accounting Principles in the United States (“U.S. GAAP”), including differences related to revenue recognition, intangible assets, share-based compensation expense, income tax and earnings per share, and in the timing, frequency and format of annual and periodic financial statements. As a result, our financial information and reported earnings for historical or future periods could be significantly different if they were prepared in accordance with U.S. GAAP. In addition, we do not intend to provide a reconciliation between IFRS and U.S. GAAP unless it is required under applicable law. As a result, you may not be able to meaningfully compare our financial statements under IFRS with those companies that prepare financial statements under U.S. GAAP.

Risks Relating to our Industry and Intellectual Property

We face competition from the existing standard of care and any future potential changes in medical practice and technology and the possibility that our competitors may develop products, treatments or procedures that are similar, more advanced, safer or more effective than ours.

The medical device, biotechnology and pharmaceutical industries, specifically relating to the areas where we currently or intend to market our RECELL System, are intensely competitive and subject to significant changes due to technology and medical practice standards. We may face competition from any number of different sources with respect to any products we develop and commercialize.

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products, treatments or procedures that are safer, more effective, have fewer or less severe side effects, are more

 

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convenient or are less expensive than our RECELL System or any future products we develop. Many of our current or future competitors may have significantly greater financial resources and experience and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we may have. Mergers and acquisitions in the pharmaceutical, medical device, and biotechnology industries or wound care markets may result in increased concentration of resources among a smaller number of our competitors. Other early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

We could be subject to product liability lawsuits, which could result in costly and time-consuming litigation and significant liabilities.

The development of medical device products, such as our RECELL System, involves an inherent risk of product liability claims and associated financial liability and adverse publicity. Any products we may develop could be found to be harmful or to contain harmful substances and exposes us to substantial liability and risk of litigation or may force us to discontinue production. We may be unable to obtain or maintain insurance on reasonable terms or otherwise protect ourselves against potential product liability claims that could impede or prevent further business development of any products we may create and commercialize. Furthermore, a product liability claim could damage our reputation, whether or not such claims are covered by insurance or have merit. A product liability claim against us or the withdrawal of a product from the market could have a material adverse effect on our business or financial condition. Furthermore, product liability lawsuits, regardless of their success, would likely be time consuming and expensive to resolve and would divert management’s time and attention, which could seriously harm our business.

If we are unable to effectively protect our intellectual property, we may not be able to operate our business and third parties may be able to use and profit from our technology, both of which would impair our ability to be competitive

Our success will be heavily dependent on our ability to obtain and maintain meaningful patent protection for our technologies and products throughout the world. Patent law relating to the scope of claims in the technology fields in which we will operate is still evolving. The amount of ongoing protection for our proprietary rights therefor is uncertain. We will rely on patents to protect a significant part of our intellectual property and to enhance our competitive position. However, our presently pending or future patent applications may be denied, and any patent previously issued to us or our subsidiaries may be challenged, invalidated, held unenforceable or circumvented. Furthermore, the patent protections we have been granted may not be broad enough to prevent competitors from producing products similar to ours. In addition, the laws of various foreign countries in which we plan to compete, such as China, may not protect our intellectual property to the same extent as do the laws of the U.S. If we fail to obtain adequate patent protection for our proprietary technology, our ability to be commercially competitive will be materially impaired.

In the ordinary course of business and as appropriate, we intend to apply for additional patents covering both our technologies and products, as we deem appropriate. Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from practicing our technologies or developing competing products and technologies. In addition, because patent law is evolving in the life science industry, the patent positions of companies like ours are uncertain. As a result, the validity and enforceability of our patents cannot be predicted with certainty.

We may find it difficult to protect our intellectual property rights throughout the world.

Filing, prosecuting and defending patents on all of our technologies and products in every jurisdiction is expensive. Competitors could reverse engineer our technologies in jurisdictions where we have not obtained

 

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patent protection to develop their own products. These products may compete with our products and may not be covered by any patent claims or other intellectual property rights.

The laws of some countries do not protect intellectual property rights to the same extent as the laws of the U.S. and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions. This lack of protection, particularly in relation to biotechnology, could make it difficult for us to stop the infringement of our patents. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert the efforts and attention of key personnel from other aspects of our business.

We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.

If we choose to go to court to stop someone else from using the inventions claimed in our patents or our licensed patents, that individual or company has the right to ask the court to rule that these patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive and would distract our key personnel, consume time and other resources, even if we were successful in stopping the infringement of these patents. In addition, there is a risk that a court will decide that these patents are invalid or unenforceable and that we do not have the right to stop the other party from using the inventions or, even if the validity or enforceability of these patents is upheld, the court may refuse to stop the other party because the competitors’ activities do not infringe our rights.

If third parties make claims of intellectual property infringement against us, or otherwise seek to establish their intellectual property rights equal or superior to ours, we may have to spend time and money in response and potentially discontinue certain of our operations.

While we currently do not believe it to be the case, third parties may claim that we are employing their proprietary technology without authorization or that we are infringing on their patents. If such claims were made, we could incur substantial costs coupled with diversion of our management and key technical personnel in defending against these claims. Furthermore, parties making claims against us may be able to obtain injunctive or other equitable relief which could effectively halt our ability to further develop, commercialize and sell products. In the event of a successful claim of infringement, courts may order us to pay damages and obtain one or more licenses from third parties. We may not be able to obtain these licenses at a reasonable cost, if at all. Defense of any lawsuit or failure to obtain any of these licenses could prevent us from commercializing available products and have a material negative effect on our business.

Any suits filed against us by third-parties alleging we infringe their intellectual property rights could harm our business and operating results as well as our reputation.

There is considerable patent and other intellectual property activity in the industry in which we operate. We may be unaware of intellectual property rights of others that may cover some or all of our technology. Additionally, notwithstanding our receipt of a patent, a third-party may nevertheless challenge the validity of one or more claims included in the patent, which may require significant expenditure of funds, as well as time and effort by key personnel, to defend our claims.

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

In the U.S., there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or the Health Care Reform Law, was passed, which substantially changed the way health care is financed by both governmental and private insurers, and significantly impacts the U.S. healthcare industry. The Health Care Reform Law, among other things, (i) subjects biologic products to potential

 

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competition by lower-cost biosimilars, (ii) addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected, (iii) increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, (iv) establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and (v) promotes a new Medicare Part D coverage gap discount program.

In addition, other legislative changes have been proposed and adopted in the U.S. since the Health Care Reform Law was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, or the ATRA, which, among other things, delayed for another two months the budget cuts mandated by these sequestration provisions of the Budget Control Act of 2011. On March 1, 2013, the President signed an executive order implementing sequestration, and on April 1, 2013, the 2% Medicare payment reductions went into effect. Additional state and federal healthcare reform measures may be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

Our operations are subject to anti-corruption laws, including Australian bribery laws and the U.S. Foreign Corrupt Practices Act. (FCPA) and other anti-corruption laws that apply in countries where we do business.

Anti-corruption laws generally prohibit us and our employees and intermediaries from bribing, being bribed or making other prohibited payments to government officials or other persons to obtain or retain business or gain some other business advantage. We participate in collaborations and relationships with third parties whose actions could potentially subject us to liability under these anti-corruption laws. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted.

There is no assurance that we will be completely effective in ensuring our compliance with all applicable anti-corruption laws or other laws including trade related laws. If we are not in compliance with these laws, we may be subject to criminal and civil penalties, disgorgement and other sanctions and remedial measures, and legal expenses, which could have an adverse impact on our business, financial condition, results of operations and liquidity.

Likewise, any investigation of any potential violations of these laws by respective government bodies could also have an adverse impact on our reputation, our business, results of operations and financial condition

Risks Relating to Our Ordinary Shares and ADSs

We have never paid a dividend on our ordinary shares and do not intend to do so in the foreseeable future, and consequently, investors’ only opportunity to realize a return on their investment in our company is through the appreciation in the price of our ordinary shares.

We do not anticipate paying cash dividends on our ordinary shares in the foreseeable future and intend to retain all earnings, if any, for our operations. If we decided to pay dividends at some future time, we may not have sufficient funds legally available to do so. Even if funds are legally available for distribution, we may be unable to pay any dividends to our shareholders because of limitations imposed by a lack of liquidity. Accordingly, our shareholders may have to sell some or all of their ordinary shares in order to generate cash flow from their investment. Our shareholders may not receive a gain on their investment when they sell their ordinary

 

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shares and may lose some or all of their investment. Any determination to pay dividends in the future on our ordinary shares will be made at the discretion of our board of directors and will depend on our results of operations, financial conditions, contractual restrictions, restrictions imposed by applicable law, capital requirements, and other factors that our board of directors deems relevant.

As long as we remain subject to the rules of the Australian Stock Exchange and if we list on NASDAQ, we will be unable to access equity capital without shareholder approval if such equity capital sales would result in an equity issuance above regulatory thresholds and consequently we may be unable to obtain financing sufficient to sustain our business if we are unsuccessful in soliciting requisite shareholder approvals.

Our ability to access equity capital is currently limited by ASX Listing Rule 7.1 (and ASX Listing Rule 7.1A, if shareholder approval for ASX Listing Rule 7.1A additional capacity is obtained annually), which provides that a company must not, subject to specified exceptions (including approval by shareholders), issue or agree to issue during any consecutive 12-month period any equity securities, or other securities with rights to conversion to equity, if the number of those securities exceeds 15% (plus an additional 10%, if ASX Listing Rule 7.1A approval is obtained) of the number of securities in the same class on issue at the commencement of that 12-month period.

Our equity issuances will be limited by Rule 7.1 (and 7.1A, if applicable) as long as we continue to be listed on the ASX and this constraint may prevent us from raising the full amount of equity capital needed for operations without prior shareholder approval. There are also restraints on a single shareholder holding more than 20% of the issued share capital. See Risk Relating to Takeovers below.

If we are successful in listing on NASDAQ (which approval is further discussed in Item 9.C under the heading “Markets”), we will be subject to NASDAQ Listing Rule 5635(d), commonly referred to as the NASDAQ 20% Rule, which requires shareholder approval of a transaction other than a public offering involving the sale, issuance, or potential issuance by a company of ordinary shares (or securities convertible into or exercisable for ordinary shares) equal to 20% or more of the ordinary shares, or 20% or more of the voting power outstanding before the issuance for less than the greater of book or market value of the shares. While less restrictive than ASX Listing Rule 7.1 (unless ASX Listing Rule 7.1A approval is obtained, in which case it is more restrictive), the operation of the NASDAQ 20% rule could limit our ability to raise capital through issuance of shares or convertible securities without jeopardizing our listing status. If we were to violate the NASDAQ 20% rule, assuming we obtain initial listing approval, our company would be subject to delisting from NASDAQ and share prices and trading volumes would likely suffer.

There is no assurance that our NASDAQ listing application will be approved and that it will be successful.

Although our ADSs are currently quoted on the OTCQX, we intend to be listed on the NASDAQ Capital Market in 2019. There is no assurance that our NASDAQ listing application will be approved or that an active public market for our ADSs will further develop or be sustained (which approval is further discussed in Item 9.C under the heading “Markets”).

Further, if an active public market in the U.S. for the ADSs does not further develop, the market price and liquidity of the ADSs may be materially and adversely affected. While we have applied for the listing of the ADSs on the NASDAQ Capital Market, a liquid public market in the U.S. for the ADSs may not further develop or be sustained after the transition from the OTCQX market to the NASDAQ Capital Market. In the past, following periods of volatility in the market price of a company’s securities, shareholders often instituted securities class action litigation against that company. If we were involved in a class action suit, it could divert the attention of senior management and, if adversely determined, could have a material adverse effect on our results of operations and financial condition.

 

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The market price and trading volume of our ordinary shares and ADSs may be volatile and may be affected by variability in our company’s performance from period to period and economic conditions beyond management’s control.

The market price of our ordinary shares and ADSs may be highly volatile and could be subject to wide fluctuations. This means that our shareholders could experience a decrease in the value of their ordinary shares regardless of our operating performance or prospects. The market prices of securities of companies operating in the medical device and biotech sectors have often experienced fluctuations that have been unrelated or disproportionate to the operating results of these companies. In addition, the trading volume of our ordinary shares and ADSs may fluctuate and cause significant price variations to occur. If the market price of our ordinary shares declines significantly, our shareholders may be unable to resell our ordinary shares at or above their purchase price, if at all. There can be no assurance that the market price of our ordinary shares will not fluctuate or significantly decline in the future.

Some specific factors that could negatively affect the price of our ordinary shares or result in fluctuations in their price and trading volume include:

 

   

actual or expected fluctuations in our operating results;

 

   

actual or expected changes in our growth rates or our competitors’ growth rates;

 

   

results of clinical trials of our product candidates;

 

   

results of clinical trials of our competitors’ products;

 

   

regulatory actions with respect to our products or our competitors’ products;

 

   

reports of one or more patient serious adverse events;

 

   

publication of research reports by securities analysts about us or our competitors in the industry;

 

   

our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;

 

   

fluctuations of exchange rates between the U.S. dollar and the Australian dollar;

 

   

issuances by us of debt or equity securities;

 

   

litigation involving our company, including: shareholder litigation; investigations or audits by regulators into the operations of our company; or proceedings initiated by our competitors or clients;

 

   

strategic decisions by us or our competitors, such as acquisitions, divestitures, spin-offs, joint ventures, strategic investments or changes in business strategy;

 

   

sales or perceived potential sales of the ADSs or ordinary shares by us, our directors, senior management or our shareholders in the future;

 

   

short selling or other market manipulation activities;

 

   

announcement or expectation of additional financing efforts;

 

   

terrorist acts, acts of war or periods of widespread civil unrest;

 

   

natural disasters and other calamities;

 

   

changes in market conditions for biopharmaceutical stocks;

 

   

our inability to raise additional capital, limiting our ability to continue as a going concern;

 

   

changes in market prices for our product or for our raw materials;

 

   

changes in market valuations of similar companies;

 

   

changes in key personnel for us or our competitors;

 

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speculation in the press or investment community;

 

   

changes or proposed changes in laws and regulations affecting our industry;

 

   

conditions in the financial markets in general or changes in general economic conditions.

The requirements of being a public company in the U.S. may strain our resources and divert management’s attention.

As a public company, we will be subject to the reporting requirements of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”), the U.S. Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), the Dodd-Frank Act, the listing standards of the NASDAQ Capital Market as applicable to a foreign private issuer, which are different in some material respects from those required for a U.S. public company, as well as the reporting requirements under the ASX. We expect that the requirements of these rules and regulations will increase our legal, accounting and financial compliance costs, make some activities more difficult, time consuming and costly, and place significant strain on our personnel, systems and resources. As a result of disclosure of information in this filing or future filings required of a public company, our business and financial condition will become more visible, which may result in threatened or actual litigation, including by competitors, shareholders or third parties. If such claims are successful, our business and operating results could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these claims, and the time and resources necessary to resolve them, could divert the resources of our management and harm our business and operating results.

As a foreign private issuer, if and after our shares are listed on the NASDAQ Capital Market, we will be permitted and intend to follow certain home-country corporate governance practices in lieu of certain NASDAQ requirements applicable to U.S. issuers, affording less protection to holders of our ordinary shares.

As a foreign private issuer, if and after our ADSs are listed on the NASDAQ Capital Market, we will be permitted to follow certain home-country corporate governance practices in lieu of certain NASDAQ requirements. We intend to avail ourselves of all such exemptions available to us, including without limitation, the following:

 

   

As a company incorporated in Australia and listed on the ASX, we expect to follow our home country practice with respect to the composition of our Board and committees;

 

   

Unlike the NASDAQ requirements, the corporate governance practice and requirements in Australia do not require us to have a majority of our board of directors to be independent, but if we do not do so, the Company is required to disclose annually to all shareholders which corporate governance recommendations (such as having a majority of our board of directors to be independent) have not been adhered to, why they have not been and what has been done in place of compliance with those recommendations;

 

   

Our Board is not required under home country regulations to hold regular executive sessions (but is free to do so at any time) where only independent directors are present (but any director with a personal interest in the outcome of an item being voted on is excluded from the deliberation and/or voting, unless the Board determines otherwise) and we do not intend to do so if our listing on NASDAQ is approved.

Such Australian home-country practices may afford less protection to holders of our ordinary shares than would be available to our shareholders if we were incorporated in the U.S., governed by U.S. law and subject to all applicable NASDAQ regulations. At any general meeting of shareholders a resolution put to the vote of the meeting must be decided on a show of hands unless a poll is effectively demanded, and the demand is not withdrawn. On a show of hands, each member present in person and each other person present as a proxy, attorney or representative of a member has one vote. On a poll, each member present in person has one vote for

 

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each share held by the member and each person present as proxy, attorney or representative of a member has one vote for each share held by such member that the person represents. Voting based on a show of hands may make it more difficult for shareholders to influence our management. NASDAQ rules require that the quorum required for a meeting of shareholders be not be less than 33 1/3 percent of the outstanding shares of the Company’s ordinary shares, however, we intend to follow our home-country corporate governance practices with respect to quorum, and as a result, the quorum required for an ordinary meeting of shareholders will consist of at least three shareholders present in person, or by proxy, attorney or representative appointed pursuant to our Constitution. As required for foreign private issuers, each NASDAQ requirement with which we do not intend to comply, if and after our ordinary shares are listed on the NASDAQ Capital Market, is listed below under Item 6.C, together with a description of our applicable home-country practice. Please refer also to Item 9.C under the heading “Markets” for further discussion about the status of our NASDAQ listing application.

We are a “foreign private issuer” under the rules and regulations of the SEC and are thus exempt from a number of rules under the Exchange Act and will be permitted to file less information with the SEC than a company incorporated in the U.S.

As a “foreign private issuer” under the Exchange Act, we are exempt from certain rules under the Exchange Act and will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act, or to comply with Regulation FD, which restricts the selective disclosure of material nonpublic information. In addition, we will be exempt from certain disclosure and procedural requirements applicable to proxy solicitations under Section 14 of the Exchange Act. Our officers, directors and principal shareholders are exempt from the reporting and “short-swing” profit recovery provisions of Section 16 of the Exchange Act. Accordingly, there may be less publicly available information concerning us than there is for a company domiciled in the U.S., and such information may not be provided as promptly as it is currently provided by companies domiciled in the U.S. If we lose our status as a foreign private issuer, we will no longer be exempt from such rules and, among other things, will be required to file periodic reports and financial statements with the SEC as if we were a company incorporated in the U.S. The costs incurred in complying with these additional requirements could be substantial.

The dual listing of our ordinary shares and the ADSs may adversely affect the liquidity and value of the ADSs.

After the ADSs are listed on the NASDAQ Capital Market, our ordinary shares will continue to be listed on the ASX. Although the ADSs currently trade on the OTCQX market, we cannot predict the effect of the transition of this dual listing to trading on of the ADSs on NASDAQ Capital Market will have on the value of our ordinary shares and ADSs. However, the dual listing of our ordinary shares and ADSs may dilute the liquidity of these securities in one or both markets and may adversely affect the further development of an active trading market for the ADSs in the U.S. The price of the ADSs could also be adversely affected by trading in our ordinary shares on the ASX.

Changes in foreign currency exchange rates could impact amounts you receive as a result of any dividend or distribution we declare on our ordinary shares.

Any significant change in the value of the Australian dollar may impact amounts you receive in U.S. dollars as a result of any dividend or distribution we declare on our ordinary shares as a holder of our ADSs.

More specifically, at present any dividends that we may pay on our ordinary shares will be in Australian dollars. The depositary for the ADSs has agreed to pay to you the cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses, including any such fees or expenses incurred to convert any such Australian dollars into U.S. dollars. You will receive any such distributions in U.S. dollars in proportion to the number of our ordinary shares your ADSs represent. Depreciation of the U.S. dollar against the Australian dollar would have a negative effect on any such distribution payable to you.

 

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Holders of our ADSs have fewer rights than shareholders under Australian law, and their voting rights are limited by the terms of the deposit agreement.

The rights of shareholders under Australian law to take actions, such as voting their shares, receiving dividends and distributions, examining our accounting books and records, bringing derivative actions, and exercising appraisal rights, are available only to shareholders of record. Because the depositary, through its custodian agents, is the record holder of the ordinary shares underlying the ADSs, only the depositary can exercise those rights in connection with the deposited shares.

Holders of ADSs may exercise their voting rights only in accordance with the provisions of the deposit agreement. For more information see the description of the deposit agreement in Item 12C. Upon receipt of voting instructions from them in the manner set forth in the deposit agreement, the depositary will make efforts to vote the shares underlying the ADSs in accordance with the instructions of ADS holders. The depositary and its agents may not be able to send voting instructions to holders of ADSs or carry out their voting instructions in a timely manner. Furthermore, the depositary and its agents will not be responsible for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, holders of ADSs may not be able to exercise their right to vote. If we do not request the depositary to solicit your voting instructions, you can still send voting instructions, and, in that case, the depositary may try to vote as you instruct, but it is not required to do so.

Holders of ADSs may not receive distributions on our ordinary shares or any value for them if it is illegal or impractical to make them available to such holders.

The depositary of our ADSs has agreed to pay holders of ADSs the cash dividends or other distributions it or the custodian for our ADSs receives on our ordinary shares or other deposited securities after deducting its fees and expenses. Holders of ADSs will receive these distributions in proportion to the number of our ordinary shares that such ADSs represent. However, the depositary is not responsible for making such payments or distributions if it is unlawful or impractical to make a distribution available to any holders of ADSs. For example, it would be unlawful to make a distribution to a holder of ADSs if it consists of securities that require registration under the Securities Act of 1933, as amended (the “Securities Act”), but that are not properly registered or distributed pursuant to an applicable exemption from registration. The depositary is not responsible for making a distribution available to any holders of ADSs if any registration or other governmental approval required for such distribution cannot be obtained after reasonable efforts. We have no obligation to take any other action to permit distributions on our ordinary shares to holders of ADSs. This means that holders of ADSs may not receive the distributions we make on our ordinary shares if it is illegal or impractical to make them available to such holders. These restrictions may materially reduce the value of our ADSs.

Holders of ADSs may be subject to transfer limitations.

The ADSs are transferable on the books of the depositary. However, the depositary may close its transfer books at any time or from time to time when it deems expedient in connection with the performance of its duties. In addition, the depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary deems it advisable to do so because of any government or governmental body or legal requirement, or under any provision of the deposit agreement, or for any other reason.

ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action.

The deposit agreement governing the ADSs representing our shares provides that holders and beneficial owners of ADSs irrevocably waive the right to a trial by jury in any legal proceeding arising out of or relating to the deposit agreement or the ADSs, including in respect of claims under federal securities laws, against us or the

 

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depositary to the fullest extent permitted by applicable law. If this jury trial waiver provision is prohibited by applicable law, an action could nevertheless proceed under the terms of the deposit agreement with a jury trial. To our knowledge, the enforceability of a jury trial waiver under the federal securities laws has not been finally adjudicated by a federal court.

However, we believe that a jury trial waiver provision is generally enforceable under the laws of the State of New York, which govern the deposit agreement, by a court of the State of New York or a federal court, which have non-exclusive jurisdiction over matters arising under the deposit agreement, applying such law. In determining whether to enforce a jury trial waiver provision, New York courts and federal courts will consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party has knowingly waived any right to trial by jury. We believe that this is the case with respect to the deposit agreement and the ADSs. In addition, New York courts will not enforce a jury trial waiver provision in order to bar a viable setoff or counterclaim sounding in fraud or one which is based upon a creditor’s negligence in failing to liquidate collateral upon a guarantor’s demand, or in the case of an intentional tort claim (as opposed to a contract dispute), none of which we believe are applicable in the case of the deposit agreement or the ADSs. Neither do we believe that any condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs of compliance with any provision of the Securities Act or the Exchange Act or the rules and regulations promulgated by the SEC thereunder. Neither does the waiver provision serve as a waiver of our or the depositary’s compliance with federal securities laws. If you or any other holder or beneficial owner of ADSs brings a claim against us or the depositary in connection with such matters, you or such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and/or the depositary. If a lawsuit is brought against us and/or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the venue of the hearing.

We are incorporated under the laws of Australia, and U.S. investors may face difficulties in protecting their interests, and their ability to protect their rights through the U.S. federal courts may be limited.

It may be difficult to bring and enforce actions against us because we are incorporated under the laws of Australia. Some or all of our directors will reside in various jurisdictions outside the U.S. As a result, it may be difficult for investors to effect service of process within the U.S. upon our non-U.S. directors, or enforce judgments obtained in the U.S. courts against us or our non-U.S. directors.

In addition, there is some doubt as to whether the courts of Australia and other countries would recognize or enforce judgments of U.S. courts obtained against us or our directors or officers based on the civil liabilities provisions of the federal or state securities laws of the U.S. or would hear actions against us or those persons based on those laws. Some remedies available under the laws of U.S. jurisdictions, including some remedies available under the U.S. federal securities laws, may not be allowed in Australia courts. Therefore, a final judgment for the payment of money rendered by any federal or state court in the U.S. based on civil liability, whether or not based solely on U.S. federal or state securities laws, may not be enforceable in countries other than the U.S.

If research analysts publish unfavorable commentary or downgrade our ordinary shares it could adversely affect our share price and trading volume.

The trading market for our ordinary shares will depend, in part, on the research and reports that research analysts publish about us and our business and industry. If one or more research analysts downgrade our shares, publish unfavorable commentary about the Company or cease publishing reports about us or our business, the price of our ordinary shares could decline. If one or more of the research analysts ceases coverage of our

 

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company or fails to publish reports on us regularly, demand for our ordinary shares could decrease, which could cause our share price or trading volume to decline.

We may be classified as a passive foreign investment company for U.S. federal income tax purposes, which could subject U.S. investors in our ordinary shares to significant adverse U.S. income tax consequences.

Depending upon the value of our ordinary shares, which underlie the value of our ADSs, and the nature of our assets and income over time, we could be classified as a “passive foreign investment company”, or “PFIC”, for U.S. federal income tax purposes. Based upon our current income and assets and projections as to the value of our ordinary shares, we do not presently expect to be a PFIC for the current taxable year or the foreseeable future. While we do not expect to become a PFIC, if among other matters, our market capitalization is less than anticipated or subsequently declines, we may be a PFIC for the current or future taxable years. The determination of whether we are or will be a PFIC will also depend, in part, on the composition of our income and assets, which will be affected by how, and how quickly, we use our liquid assets. Because PFIC status is a factual determination made annually after the close of each taxable year, including ascertaining the fair market value of our assets on a quarterly basis and the character of each item of income we earn, we can provide no assurance that we will not be a PFIC for the current taxable year or any future taxable year.

If we were to be classified as a PFIC in any taxable year, a U.S. holder (as defined in Item 10E under the heading “U.S. Federal Income Tax Considerations”) would be subject to special rules generally intended to reduce or eliminate any benefits from the deferral of U.S. federal income tax that a U.S. holder could derive from investing in a non-U.S. corporation that doses not distribute all of its earnings on a current basis. Further, if we are classified as a PFIC for any year during which a U.S. holder holds our ordinary shares, we generally will continue to be treated as a PFIC for all succeeding years during which such U.S. holder holds our ordinary shares. For more information see Item 10E.2 under the heading “U.S. Federal Income Tax Considerations –  Passive Foreign Investment Company Rules”.

Risks Relating to Takeovers

Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our ordinary shares, which could constrain our share price and reduce investor returns.

We are incorporated in Australia and are subject to the takeover laws of Australia, including the Australian Corporations Act 2001 (“Corporations Act”). Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in a company’s issued voting shares if the acquisition of that interest will lead to a person’s voting power in such company increasing from 20% or below to more than 20%, or increasing from a starting point that is above 20% and below 90% without prior shareholder approval or the acquisition otherwise being exempt under the Corporations Act. Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our ordinary shares. This may have the ancillary effect of depriving or limiting our shareholders’ strategic opportunities to sell their ordinary shares and may restrict the ability of our shareholders to obtain a premium from such transactions. See Item 10D under the heading, “The Foreign Acquisitions and Takeovers Act 1975.”

Our constitution and applicable Australian laws and regulations may adversely affect our ability to take actions that could be beneficial to our shareholders.

As an Australian company we are subject to different corporate requirements than a corporation organized under the laws of the U.S. Our Constitution, as well as the Corporations Act, set forth various rights and obligations that are unique to Australian companies. These requirements operate differently than from many U.S. companies and may limit or otherwise adversely affect our ability to take actions that could be beneficial to our shareholders. Prior to investing in our ordinary shares investors should carefully review the summary of these matters set forth under Item 10B, under the heading “Memorandum and Articles of Association”, as well as the copy of our complete Constitution, which is included as an exhibit to this registration statement.

 

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ITEM 4. INFORMATION ON THE COMPANY

A. History and Development of the Company

We were incorporated under the laws of the Commonwealth of Australia on December 21, 1992 and commenced operating under the name “AVITA Medical Limited” October 6, 2008. The registered office is located at c/o Mertons Corporate Services Pty Ltd Level 7 330 Collins Street Melbourne VIC 3000, Australia, telephone number is +61 (0) 3 8689 9997 and fax number +61 (0) 8 9474 7742. Our corporate office and principal U.S. office is located at 28159 Avenue Stanford, Suite 220, Valencia, CA 91355, telephone number is+1 661 367 9170. Our address on the Internet is https://avitamedical.com. The information on, or accessible through, our website is not part of this registration statement on Form 20-F.

B. Business Overview

We are a regenerative medicine company with a technology platform positioned to address unmet medical needs in burn injuries, trauma injuries, chronic wounds, and dermatological and aesthetics indications. Our patented and proprietary platform technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The medical devices work by preparing Spray-On Skin™ Cells, an autologous cellular suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. This autologous suspension is sprayed onto the areas of the patient requiring treatment.

Our first U.S. product, the RECELL® System, was approved by the U.S. Food and Drug Administration (FDA) in September 2018 for the treatment of acute thermal burn injuries in patients 18 years and older. The RECELL System is used to prepare Spray-On Skin Cells using a small amount of a patient’s own skin, providing a new way to treat severe burns that significantly reduces the amount of donor skin required. The RECELL System is designed to be used at the point of care alone or in combination with split-thickness skin autografts depending on the depth of the burn injury. Compelling data from prospective, randomized, controlled clinical trials conducted at major U.S. burn centers and real-world use globally, demonstrate that the RECELL System is a significant advancement over the current standard of care for burn patients and offers benefits in clinical outcomes and cost savings.

The RECELL System is Therapeutic Goods Administration (TGA)-registered in Australia and China Food and Drug Administration (CFDA)-cleared in China for use in the treatment of burns, acute wounds, scars and vitiligo. In Europe, the RECELL System received CE-mark approval for the treatment of burns, chronic wounds, scars and vitiligo.

Markets and Limitations of Standard of Care

Acute Thermal Burns

Acute thermal burns are life-threatening and debilitating injuries that are among the most expensive traumatic injuries to manage because of complex surgical procedures, long and costly hospitalization, rehabilitation and scar treatment. In the U.S., the largest market for the treatment of burns, approximately 486,000 people seek treatment for burns each year. Of these, at least 40,000 have burn injuries severe enough to require in-patient treatment, and it is estimated that 3,300 die each year. The majority of patients treated on an in-patient basis in the U.S. are treated in specialized burn centers. Countries outside the U.S. are smaller markets for the treatment of burns. For example, in Japan, the second largest healthcare market in the world, approximately 6,000 patients with severe burns treated in hospitals each year.

The severity of the burn is generally assessed based on the extent of the area burned, and the depth of the burns. The extent of the patient’s burn injury is typically described in terms of percent of total body surface area, or “TBSA.” For example, a burn covering an average sized adult arm would be roughly a 9% TBSA, while a

 

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burn covering an entire leg would be roughly an 18% TBSA. The depth of the burn, referred to in terms of “degree” is generally classified into four categories:

 

   

Superficial or first-degree burns: Burns that do not penetrate through the epidermis and typically heal naturally.

 

   

Partial-thickness or second-degree burns: Characterized by extending through the epidermis and including varying amounts of damaged dermis. Can be further subdivided into superficial and deep partial-thickness burns.

 

   

Full thickness or third-degree burns: Characterized by injury to the entire dermal tissue down to the subcutaneous fat.

 

   

Fourth-degree burns: Such burns are rare and extend beyond the subcutaneous fat tissue into the underlying structures, such as muscle or bone.

Burn treatment is dictated by the depth and extent of the injury, and deeper and more extensive injuries are most commonly treated with autologous split-thickness skin grafts (STSG) to achieve definitive closure of the burn wound. In a STSG, or autograft, the donor skin is harvested from a healthy part of the patient using a device called a dermatone as detailed in the pictures below. The donor skin is then transferred to the burn injury that has been prepared (debrided or cleaned).

Harvesting of Donor Skin for Use in Autografting

 

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Harvesting skin from donor site

for autograft

  

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Donor site wound created while harvesting skin for autograft

  

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Typical donor site scar 52 weeks post procedure

Treatment with STSG creates additional trauma for the patient due to the harvesting of healthy donor skin. Although the use of STSG has been a standard treatment for more than 50 years, grafting is associated with significant pain, pruritus, infection, dyschromia, dyspigmentation, delayed healing, and hypertrophic scarring of the donor site.

The clinical benefits of earlier intervention for burn wounds are well recognized and include increased survival, reduced hospital length of stay, decreased pain duration, and reduced infection-related complications. However, in large TBSA injuries, the patient may not have enough donor skin available to allow for immediate treatment of the entire area of burn injuries with traditional grafting techniques. The lack of available healthy donor skin in patients with high TBSA burn injuries is often the central problem impacting time to autografting and definitive closure of the wounds. In severely burned patients, doctors often must wait until the donor sites have healed so that they can reharvest from the site, resulting in delays in treatment and healing, requiring multiple procedures and extended hospital time. While waiting for donor skin the burn wounds may be temporarily covered by allogenic skin graft, for example allograft (cadaver skin) or xenograft (typically pig skin). The overall cost of treatment with STSG is expensive, for example approximately US$579,000 and 59.4 days in hospital for a patient with a 40% TBSA mixed or full-thickness burn.

Because of the limited donor skin available for harvest in patients with high TBSA injuries, researchers have developed alternatives such as cultured epidermal autografts (CEA) in which a skin biopsy is taken from a patient and the cells are grown into sheets of skin in a laboratory and then returned for autografting onto the

 

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patient. Limitations associated with CEAs, including Epicel® from Vericel Corporation, include the time to grow the sheets of skin (approximately three weeks), the fact that the skin grown contains only keratinocytes and therefore lack the melanocytes that provide pigmentation, and the high cost. As a result, CEAs have been lifesaving in very high TBSA patients (> 30% TBSA) but in the U.S. the use of CEAs have been limited to approximately 100 patients per year.

Trauma Wounds (Soft Tissue Injuries)

Trauma wounds or soft tissue injuries include abrasions, lacerations, punctures, gunshot wounds, crush wounds, and degloving. Severe traumatic wounds may require surgical intervention to close the wound and stabilize the patient. The most common trauma injuries requiring autografting are degloving and crush wounds. The harvesting and autografting procedures for trauma wounds are similar to the treatment of severe burn injuries, as are the limitations and shortcomings. Patients requiring autografting for trauma wounds are often treated in trauma centers in hospitals by plastic surgeons. Approximately half of the surgeons treating patients with severe burns requiring autografting in the U.S. also treat trauma patients requiring autografting, therefore the soft tissue injury market complements our commercialization efforts related to the U.S. burn market.

Vitiligo and Other Dermatological Indications

Vitiligo is a disease that causes the loss of skin pigmentation or color in patches which tend to increase in size over time. The extent and rate of color loss from vitiligo is unpredictable, can affect the skin on any part of the body, and may also affect hair and the inside of the mouth. Non-segmental vitiligo is the most common variant and impacts the majority of patients and is characterized by symmetrical patches that appear on both sides of the body; as on hands and knees.

Vitiligo occurs when melanocytes, the pigment-producing skin cells, die or stop producing melanin, the pigment that gives skin, hair and eyes color. Vitiligo is believed to be an autoimmune disorder in which a patient’s immune system attacks and destroys the melanocytes in the skin. It may also be caused by heredity factors or a triggering event, such as sunburn, stress or exposure to industrial chemicals. Vitiligo affects people of all skin types, but it may be more noticeable in people with darker skin. The condition is not life-threatening or physically painful but can significantly alter physical appearance, have negative emotional and psychological consequences, and impair quality of life.

Vitiligo cannot be cured at present, and medical treatments generally fall into one of two categories:

 

   

Treatments to arrest the spread of vitiligo, such as steroid creams and non-steroidal anti-inflammatory creams. There are also a number of therapies under development designed to target the underling autoimmune disease. One challenge in terms of achieving the desired patient outcome is that stopping the spread of vitiligo will not restore pigmentation to the areas already damaged.

 

   

Treatments to restore pigmentation include makeup and coverups, dermabrasion, laser, drug-light combinations, and autografts.

Survey results reveal a low level of patient satisfaction with current treatment options. The majority of vitiligo patients in the U.S. are treated by dermatologists. In 2016, China accounted for the highest prevalence in the world with 7.7 million cases, followed by the U.S. 2.6 million cases, Japan with 2.1 million and the EU with 1.4 million.

We expect to explore potential benefits of variants of the RECELL System platform in the aesthetics markets, estimated to be a US$10 billion market in the U.S. alone in 2018. As part of this program the Company may also target certain orphan diseases, such as epidermolysis bullosa and Hutchinson-Gilford progeria syndrome (HGPS) which are both rare genetic condition that require more effective treatments.

 

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Chronic Wounds

The chronic and other hard-to-heal wound market consists of a broad population of more than 6 million patients in the U.S. suffering from condition such as venous leg ulcers, diabetic foot ulcers, pressure ulcers and non-healing surgical wounds. Chronic and other hard-to-heal wounds represent a US$25 billion burden to the U.S. healthcare system. Chronic and hard-to-heal wounds are caused by impairment in the biochemical and cellular healing processes due to local or systemic conditions and generally can take weeks or months to heal, if not longer. Such wounds can lead to significant morbidity, including pain, infection, impaired mobility, hospitalization, reduced productivity, amputation and mortality.

Venous Leg Ulcers:

Venous leg ulcers (VLUs) are associated with poor venous return (ischemia), primarily occurring as a result of age, obesity, previous leg injuries, deep venous thrombosis, and phlebitis. Venous ulcers are often recurrent, and an open ulcer can persist for weeks to many years. Treatment options for venous ulcers include leg elevation, compression therapy, dressings, pentoxifylline, and aspirin therapy. Surgical management is also indicated for ulcers that are large, of prolonged duration, or refractory to conservative measures. The refractory nature of these ulcers increases the risk of morbidity and mortality and they have a significant impact on patient quality of life. The financial burden of venous ulcers is estimated to be $2 billion per year in the U.S.

Diabetic Foot Ulcers:

A diabetic foot ulcer (DFU) is an open sore or wound and is commonly located on the bottom of the foot. Approximately 5% to 7% of people with diabetes currently have or previously had a DFU, and approximately 25% will develop a DFU in their lifetime. Of those who develop a foot ulcer, 6% will be hospitalized due to infection or other ulcer-related complication. DFUs are the leading cause of non-traumatic lower extremity amputations in the U.S. In the U.S., it is estimated that 1.3 million people have DFUs, and over US$15 billion was spent on the care of this condition. Depending on the severity of the DFU, treatment includes offloading therapy to help redistribute foot pressure away from the ulcer, advanced wound dressings, and negative pressure wound therapy. For DFUs that require surgical closure, autografts, skin substitutes, or biologics can be utilized.

The RECELL System

The RECELL® Autologous Cell Harvesting System (RECELL System) uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells, an autologous cellular suspension comprised of the patient’s skin cells necessary to regenerate natural healthy epidermis. These Spray-On Skin Cells are prepared using the RECELL System at the point of care in as little as 30 minutes, providing a new way to treat thermal burns and other wounds or defects of the skin. The regenerative skin cell suspension includes keratinocytes, fibroblasts, and melanocytes, all of which play a critical role in wound healing. The ability of the RECELL System to retain melanocytes in the cell suspension is notable as these cells are fragile and are critical for the restoration of natural pigmentation to the area treated.

The RECELL System is a single-use (disposable), stand-alone, battery operated, autologous cell harvesting device containing enzymatic and buffer solutions, sterile surgical instruments, and actuators to achieve the disaggregation and delivery of skin cells. A small skin sample from a patient is enzymatically and mechanically processed in the RECELL System at the point of care to isolate skin cells and to produce a suspension of Spray-On Skin Cells for immediate delivery onto a prepared wound bed. The RECELL System can be used to prepare enough suspension to treat a wound up to 80 times the size of the donor skin sample. For example, a skin sample approximately the size of a credit card can be used to treat a wound that covers an adult patient’s entire back.

 

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Preparation and Application of Spray-On Skin Cells Using the RECELL System

 

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Processing of skin sample in RECELL System to

prepare Spray-On Skin Cells

  

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Application of Spray-On Skin Cells

to a patient’s burn injury

In the U.S., the RECELL System is approved by the FDA for use in the treatment of acute thermal burn wounds in patients 18 years and older. The RECELL System is approved for use by appropriately-licensed healthcare professionals at the patients point of care to prepare autologous Spray-On Skin Cells for direct application to acute partial-thickness burns, or application in combination with meshed autografting for acute full-thickness burns. In the U.S., the RECELL System is produced in a configuration that allows the preparation of up to 24 ml of cell suspension which can be used to cover an acute wound area up to 1,920 cm², or approximately 10% of a patient’s body.

In Australia, the RECELL System is TGA-registered for the treatment of burns, acute wounds, scars and vitiligo. In China, the RECELL System is CFDA-cleared for the treatment of burns, acute wounds, scars and vitiligo. The RECELL system is produced in a configuration that allows for treatment of up to 320 cm² for the markets in Australia and China. In Europe, the RECELL System received CE-mark approval for the treatment of burns, chronic wounds, scars and vitiligo.

The RECELL System Clinical Results and Ongoing and Planned Clinical Trials

The September 2018 FDA approval of the RECELL System for use in the treatment of acute thermal burns in patients 18 and older was supported by two prospective, randomized, controlled pivotal clinical trials, one in deep partial-thickness (second-degree) burns and one in mixed and full-thickness (third-degree) burns. The randomized, controlled trials demonstrated that treatment using the RECELL System requires substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment. The results of these clinical studies have been published in peer-reviewed scientific publications and have been presented at burn meetings and other major scientific conferences. Presentations by key opinion leaders have been made at over 20 scientific conferences in 2018 and 2019, including presentations of the pivotal clinical trial results and the clinical results related to use of the RECELL System in the treatment of burns in specific subgroups of patients and types of burn injuries, including facial burns and large TBSA burns. Patients included in many of these presentations were treated as part of the FDA-approved Investigational Device Exemption (IDE) Compassionate Use and Continued Access programs made available to burn patients prior to the FDA approval.

In addition to and extensive clinical trial program in acute thermal burns in adults, earlier-stage clinical studies have been conducted in pediatric burns, scald injuries, treatment of donor sites, vitiligo, chronic wounds (venous leg ulcers and diabetic foot ulcers), scar hypopigmentation, and acute trauma.

 

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The RECELL System Clinical Results in Thermal Burns

RECELL Pivotal Clinical Trial in Second-Degree Acute Thermal Burns

One of the two randomized, controlled clinical trials of the RECELL System supporting the September 2018 FDA approval was a study of patients with partial-thickness (second-degree burns) conducted at 12 U.S. burn centers. The pivotal trial evaluated 101 adult patients with thermal, partial-thickness burns covering 1% to 20% of their total body surface area. Patients served as their own control, and two comparable burn sites were selected for comparative testing on each patient. One burn site on each patient was treated with Spray-On-Skin Cells prepared using the RECELL System, while the other burn site was treated with the standard treatment, consisting of meshed autograft expanded 2:1.

During the pivotal trial, the patient donor skin required to be harvested to treat burn sites using the RECELL System was 97.5% less than the amount harvested to treat burn sites with the standard of care (p<0.001). Despite the statistically significant reduction in donor skin required to treat with the RECELL System, burn sites treated using the RECELL System achieved definitive closure and long-term outcomes, including durability, comparable to the burn sites treated with standard of care.

Reduction in Donor Skin Requirements in Pivotal Trial in Second-Degree Burns

 

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Statistically significant reduction in donor skin

requirement for use of the RECELL System in treatment

versus standard 2:1 meshed autograft

 

 

Comparison of donor skin requirement for participant in

clinical trial. Requirement for 2:1 mesh autograft

(STSG) versus requirement for treatment using the

RECELL System

Secondary endpoints measured in the trial highlighted additional clinical benefits of the significant reduction in donor skin harvested for treatment using the RECELL System, including:

 

   

Significantly less donor-site pain (p£0.0025)

 

   

Significantly higher patient satisfaction with donor-site appearance (p£0.0025)

 

   

Significantly better donor-site scarring results (p£0.0025)

 

   

Significantly greater incidence of donor-site healing at two weeks (p<0.001), with an odds ration of 4:3

In the clinical trial, use of the RECELL System in the trial was safe and well tolerated with adverse experiences typical for the type of burn injury sustained. The results of this trial were published in a peer-reviewed scientific publication, the Journal of Burn Care & Research, in September 2018.

 

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RECELL Pivotal Clinical Trial in Third-Degree Acute Thermal Burns

The second randomized, controlled clinical trial of the RECELL System supporting the September 2018 FDA approval was a study of patients with mixed and full-thickness (third-degree burns) conducted at seven U.S. burn centers. The pivotal trial evaluated 30 patients ranging in age from nine to 68 years old with thermal, mixed-thickness burns, including full-thickness burns, covering 5% to 46% of their total body surface area. Patients served as their own control, and two comparable burn sites were selected for comparative testing on each patient. One burn site was treated with the standard treatment, meshed autograft, while the other was treated with Spray-On-Skin Cells prepared using the RECELL System combined with more widely meshed autografts (for example, if a 2:1 meshed autograft was used to treat the control burn site, then a 3:1 meshed autograft used in combination with Spray-On Skin Cells was used to treat the RECELL site). The co-primary endpoints of the pivotal trial were reduction in donor skin requirements and non-inferiority in complete wound closure.

The pivotal clinical trial achieved its co-primary endpoints, demonstrating a statistically significant reduction in donor skin requirements versus standard of care while achieving comparable definitive wound closure. Treatment using the RECELL System achieved comparable healing, long-term scar and patient satisfaction outcomes using significantly less donor skin with no safety concerns. During the pivotal trial, the patient donor skin required to be harvested to treat burn sites with the RECELL System was 32% less than the amount harvested to treat burn sites with the standard of care (p<0.001). Despite the statistically significant reduction in donor skin required to treat using the RECELL System, eight weeks post treatment 92% of the burn sites treated using the RECELL System achieved complete healing versus 85% for the sites treated with the standard of care, demonstrating non-inferiority.

Reduction in Donor Skin Requirements in Pivotal Trial in Second-Degree Burns

 

 

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  Statistically significant reduction in donor skin

  requirement for use of the RECELL System in

  combination with widely-meshed autographs

  treatment versus standard meshed autograft.

 

Use of the RECELL System was safe and well tolerated with no device-related adverse events. The results of this trial were published online ahead of print in a peer-reviewed scientific publication, Burns, in December 2018, and will appear in the print version of the journal in 2019.

 

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BEACON Cost-Effectiveness Model Demonstrates Costs Savings Associated with use of RECELL System in Treatment of Severe Burns

To investigate the value proposition and potential transformative health economic impact of the RECELL System in burn care, a hospital-perspective cost-effectiveness model was developed by IQVIA, the Biomedical Advanced Research and Development Authority (BARDA), and AVITA Medical. The Burn-MCM (Medical Counter Measure) Effectiveness Assessment Cost Outcomes Nexus (BEACON) model evaluates how practice patterns, interventions and patient characteristics interact across all phases of care (wound assessment, debridement/excision, temporary coverage and permanent closure) to understand how patient and burn center outcomes change given the incorporation of a new burn care treatment, such as the RECELL System.

As described in a peer-reviewed scientific publication in Advances in Therapy, accepted in April 2019, the BEACON model uses sequential decision trees to depict the acute care pathway for burn patients, and then predicts how the RECELL System would modify treatment for patients with burns ranging from 10% to 40% TBSA. Clinical inputs were derived from randomized controlled trials, burn surgeon surveys and interviews, and the American Burn Association National Burn Repository. An accompanying budget impact model builds on the cost-effectiveness calculations to evaluate overall cost impact to a burn center or payor associated with incorporation of the RECELL System into patient care.

The BEACON model shows that treatment using the RECELL System for deep partial-thickness burns reduces total treatment costs by an average of 26%, or approximately US$37,000, for patients with 10% TBSA and 40%, or approximately US$150,000, for patients with 40% TBSA. For full-thickness burns, treatment using the RECELL System reduced total treatment cost by 3%, or approximately US$6,000, for patients with 10% TBSA, and by 42% or approximately US$243,000, for patients with 40% TBSA. The cost reductions are attributed to decreasing the length of hospital stay, the number of procedures required to close the burn wound, the donor site size and associated wound care, and number of downstream contracture release procedures. All cost savings estimates are net of the cost of the RECELL System.

The budget impact model was also used to calculate the annual budget impact of current standard of care for the treatment of burns versus treatment using the RECELL System for a burn center with 200 patients. The model determined that treatment using the RECELL System would reduce annual total treatment costs from approximately US$39.4 million to US$32.6 million, saving 17% or approximately US$6.8 million.

The BEACON model may be run for the specific demographics of an individual burn center or territory, allowing the burn institution or region to evaluate the potential benefits of the RECELL System within their specific population of burn patients. As described by researchers at a presentation at the American Burn Association 51st Annual Meeting in April 2019, the patient characteristics for the Arizona Burn Center (for example, age, burn depth, TBSA) were input into the BEACON model based on the 800 patients with 10% TBSA and greater burns treated in 2018 at the institution, and demonstrated:

 

   

The Arizona Burn Center would save approximately US$28 million (16%) per year using the RECELL System versus the current standard of care (net of the cost of the RECELL System)

 

   

The largest driver of the predicted cost savings is reduction in length of stay per patient, comprising 70% of the savings

 

   

Also contributing to the estimated cost savings is an approximate 67% less autografting procedures, with reduction in operating room time contributing another 13% to the estimated cost savings

A similar presentation was made by researchers at the 31st Annual Southern Region Burn Conference in November 2018 which described the application of the BEACON model to the patient characteristics for the Firefighter Burn Center, Memphis, Tennessee, and University of Tennessee Health Science Center. The model determined that treating patients with the RECELL System alone, or in combination with widely spaced skin grafts, could reduce the burn center’s costs by up to US$21 million per year compared to conventional treatment.

 

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Major drivers of the cost savings included a decrease in length of hospital stay and a reduction in the number of surgeries and related resources (blood transfusions and dressings).

The BEACON model highlights the potential of the RECELL System to improve patient care in the treatment of severe burns, while also providing a technique for reducing the total cost of treatment.

Additional RECELL Clinical Results in Severe Burns

A series of studies have been presented at scientific conferences and evaluated multiple patient categories and burn types in more than 150 burn patients that were treated under FDA-approved Investigational Device Exemption (IDE) Compassionate Use and Continued Access programs made available to patients prior to the FDA approval. Many of these studies includes a class of patients or types of burn injuries that fall outside of the currently approved U.S. product labeling.

RECELL in Treatment of Facial Burns

Deep partial-thickness facial burns present a challenge in reconstructive surgery. Standard of care typically includes excision and allograft followed by split-thickness autografting. Limitations of the current treatment regimen includes dyspigmentation at the sites of the skin grafts and hypertrophic scaring at the seams of the grafts, resulting in substantial patient dissatisfaction with the outcome.

At the American Burn Association 50th Annual Meeting in April 2018, clinical researchers provided a retrospective review of clinical outcomes obtained in the treatment with the RECELL System of five patients with acute deep partial-thickness facial burn injuries under the Compassionate Use IDE program. Patients in the facial burn case studies ranged from 2 to 40 years of age and had burns covering 35% to 62% TBSA. Researchers reported that in this small study, treatment using the RECELL System provided equivalent or superior results to current treatments in facial burn care in terms of wound healing, and excellent cosmetic outcomes.

A representative patient in the trial was a 12-year-old girl with 2nd-degree facial burn and widespread 3rd-degree burns, with total injuries encompassing a 62% TBSA. The patient had insufficient donor skin available for standard autografts. The healing of the patient’s facial burns is highlighted in the progressions of photographs included below.

Facial Burn Case Study

 

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Treatment Day

  

LOGO

Day 7

  

LOGO

Day 21

  

LOGO

3 months

  

LOGO

1 year

Researchers observed that the reintroduction of melanocytes as part of the cellular suspension prepared using the RECELL System resulted in an excellent cosmetic outcome. The patient did not require surgical revisions for facial contractures and was discharged from the hospital in 24 days.

RECELL in Treatment of Pediatric Patients

In patients with extensive burn injuries, lack of available donor skin is a major limitation achieving permanent closure, and the longer a wound remains open the more susceptible a patient is to infection. In the

 

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U.S., one-third of burn injuries occur in children, and the availability of donor skin for traditional meshed autografts is even more limited in pediatric patients with extensive injuries. The use of the RECELL System, a donor skin sparing technology that enables rapid definitive closure of burn wounds, has the potential to improve patient outcomes.

Interim results describing clinical outcomes for pediatric patients treated using the RECELL System were presented at the American Burn Association (ABA) 51st Annual Meeting in April 2019. The study included a total of 23 pediatric patients with a median age of 6.7 years old (ranging from 0.8 to 16.0) treated under FDA IDE Compassionate Use and Continued Access programs with mixed-depth and full-thickness (third-degree) burns. The presentation was selected as a “Best of the Best Abstract” out of more than 500 abstract submissions to the ABA meeting.

In this study of pediatric patients which included those with life-threatening thermal burn injuries, Spray-On Skin Cells prepared using the RECELL System were applied in combination with widely meshed split-thickness autografts to achieve definitive closure using minimal donor skin. A total of 107 burn wounds were treated in the study, and 98% achieved definitive healing within four weeks of treatment. Importantly, for patients with greater than 50% TBSA burns, treatment with the combination of Spray-On Skin Cells and widely meshed split-thickness autografts achieved the same high rate of healing at week four as patients with smaller burns (burns equal to or less than 50% TBSA) treated with the same combination. In addition, in the study the donor sites on all patients were treated with Spray-On Skin Cells, and 62.5% of the donor sites were healed within a week of treatment, and 100% were completely healed within two weeks of treatment. Researcher reported that the majority of burn sites had cosmetic outcomes rated as satisfactory or equivalent compared to uninjured skin and that the early healing of donor sites contributed to a decrease between harvest times for patients with limited donor skin availability.

Two additional randomized, controlled clinical trials using the RECELL System in the treatment of pediatric patients are currently underway, and a third trial in this population is expected to begin in the middle of 2019.

RECELL Treatment of Donor Sites

In large TBSA injuries a patient may not have enough donor skin available to allow for immediate treatment of the entire area of burn injuries with traditional autografting techniques. In severely burned patients with extensive injuries, surgeons often must wait until the donor sites have healed so that they can reharvest from the site, resulting in delays in treatment and healing and the need for multiple procedures and extended hospital time.

Interim results describing clinical outcomes associated with the treatment of donor sites using the RECELL System in patients with large TBSA burn were presented at the American Burn Association 51st Annual Meeting in April 2019 (the presentation was awarded Best in Category at the meeting). In the prospective observational study of 73 subjects with life-threatening thermal burn injuries treated under the Compassionate Use program, 426 donor sites wounds were treated with Spray-On Skin Cells prepared using the RECELL System. The mean TBSA of the patients in the study was 54% with burns ranging from 20% to 91% TBSA. Two weeks after treatment, 91% of the donor sites had healed in this vulnerable patient population, and 98% had healed by week eight. Donor sites treated using the RECELL System were able to be reharvested as early as seven days after treatment. No infection or delayed healing were reported for donor sites treated with Spray-On Skin Cells. Researchers noted that the ability to reharvest additional donor skin from a site in as little one week after treatment with the RECELL System is extremely beneficial in this population of patients with extensive life-threatening injuries and limited available donor skin.

A representative patient in the study was a 16-month-old female with a 30% TBSA mixed depth thermal burn with donor sites taken from her back. Medical professionals applied Spray-On Skin Cells to her donor site wound. The donor sites were 100% re-epithelialized by within two weeks of treatment. At one-year follow-up the

 

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donor site wound had matching color, pigment, and texture to the surrounding skin. Treatment and healing of the patient’s donor site is highlighted in the photographs included below.

 

LOGO

 

Application of Spray-On Skin Cells

prepared using the RECELL System

to donor site wound

  

LOGO

 

Healing of donor site wound one year after

treatment using the RECELL System

 

 

A randomized, controlled clinical trial of the use of the RECELL System in the treatment of donor sites in pediatric patients is currently underway.

RECELL in Treatment of Patients with Extensive Burns (Large TBSA Patients)

In patients with extensive burn injuries, lack of available donor skin is a major limitation in achieving permanent closure, and the longer a wound remains open the more susceptible a patient is to infection. At the American Burn Association 51st Annual Meeting in April 2019 researchers presented data showing that the use of the RECELL System in combination with meshed autografts achieves definitive closure for patients with burn injuries greater than 50% TBSA and achieved comparable outcomes to patients with less severe injuries.

In this study of 35 patients with life-threatening thermal burn injuries, Spray-On Skin were applied in combination with widely meshed split-thickness autografts to achieve definitive closure using minimal donor skin. For patients with greater than 50% TBSA burns, 150 burn wounds were treated with the combination of Spray-On Skin Cells and widely meshed split-thickness autografts, with 95% of the wounds achieving complete wound closure two months after treatment. For patients with equal to or less than 50% TBSA burns, 53 burn wounds were treated with the same combination and the rate of healing was similar to the large TBSA patients, with 92% of wounds achieving full healing two months after treatment. Researchers reported that there was no device related adverse events and long-term durability was excellent.

Ongoing and Future Clinical Trials in Burns

U.S. Pediatric Donor Site Study:

In October 2018 we initiated a randomized, controlled clinical study in the U.S. to investigate the safety and effectiveness of Spray-On Skin Cells prepared with the RECELL System compared to conventional care for healing of donor sites in pediatric patients (infants, children and adolescents aged one to 16 years). The study will evaluate a minimum of 50 patients who require autografting in approximately eight U.S. centers. Patients who are eligible for the study may be undergoing autografting for any reason, including burns, trauma, and reconstruction. The study is a matched-pairs design where patients will serve as their own control. For each patient, two donor sites of similar surface area will be selected and randomized to be treated with Spray-On Skin Cells or serve as the control (treated with standard dressings only).

 

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The primary effectiveness endpoint is time in days for complete healing of the donor sites. Secondary and tertiary endpoints include:

 

   

Donor site treatment preference by patient / guardian at week four

 

   

Investigator donor site preference at week four

 

   

Comparative itching of donor sites post treatment

 

   

Blinded evaluator assessment of donor sites at week 24

 

   

Patient / guardian assessment of donor sites at week 24

 

   

Investigator assessment of healing at all visits

 

   

Patient or parent / guardian reported donor site pain

Patients will be followed for one-year after treatment. The pediatric donor-site study is being 100% funded by Biomedical Advanced Research and Development Authority (BARDA) under the ongoing program. This study is intended to support U.S. regulatory approval for marketing of the RECELL System for patients under the age of 18.

Australian Pediatric Scalds Study:

In August 2018 a randomized, controlled clinical study of the use of the RECELL System in the treatment of significant superficial partial- and mid-thickness pediatric burns, including scald injuries, was initiated in Australia. The current standard of care for children with partial-thickness burns is cleaning of the wound followed by a dressing application. Limitations of the standard of care include delay in healing of the burn injury, scarring, and pain. The clinical trial will include approximately 90 patients under 18 years old. Patients will be randomized into one of three groups and will be treated either using the RECELL System and Biobrane® dressing, the Biobrane dressing alone, or standard care (silver impregnated silicone lined dressing). The primary endpoint will be days to re-epithelization of the burn injury. Secondary endpoints include pain, patient satisfaction and scarring.

U.S. Pediatric Early Intervention Pediatric Study:

In late 2019 we plan to initiate a randomized, controlled clinical study to investigate the safety and effectiveness of Spray-On Skin Cells prepared with the RECELL System compared to standard of care dressings for treatment of partial-thickness burns in pediatric patients (infants, children and adolescents aged one to 16 years). The study will evaluate 160 patients in up to 18 U.S. burn centers with burns of 5% to 30% TBSA. Half of the patients will be randomized to be treated using Spray-On Skin Cells. The other half will be randomized to serve in the control group and will be treated using standard dressings.

The primary measure of effectiveness is healing ten days after treatment, as assessed by a blinded evaluator. Secondary endpoints include:

 

   

Healing time assessed from date of initial burn injury

 

   

Pain recovery (i.e., trajectory for pain resolution) following treatment

 

   

Incidence of conventional autografting to achieve healing

Patients will be followed for one-year after treatment. The pediatric early intervention study is being 100% funded by Biomedical Advanced Research and Development Authority (BARDA) under the ongoing program. This study is intended to support U.S. regulatory approval for marketing of the RECELL System for patients under the age of 18.

 

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The RECELL System Clinical Results in Vitiligo

Small pilot studies investigating the use of the RECELL System in the treatment of vitiligo have been the subject of multiple peer-reviewed scientific publications and presentations at medical conferences. A representative pilot study was published in the Journal of the American Academy of Dermatology in July 2015. A total of ten patients with hypopigmentation were included in the study, five with stable segmental vitiligo, and five with piebaldism (a disorder of melanocyte development). The study was a randomized, intra-patient-controlled pilot study in which three depigmented sites were randomly allocated to be treated with the combination of CO2 laser ablation followed by the application of Spray-On Skin Cells, CO2 laser ablation alone, or no treatment.

The median repigmentation six months after treatment was 78% in the sites treated with the combination of CO2 laser ablation followed by the application of Spray-On Skin Cells, compared to zero median repigmentation in the control groups consisting of treatment with CO2 laser ablation alone or no treatment. The repigmentation for the sites treated with the combination of CO2 laser ablation followed by the application of Spray-On Skin Cells was assessed as good or excellent by 70% of the patients. No adverse effects or long-term side effects were seen in the recipient sites. Researchers concluded that treatment with the combination of CO2 laser ablation followed by the application of Spray-On Skin Cells resulted in a high percentage of repigmentation and was well tolerated in both stable segmental vitiligo and piebaldism patients. Photographs before and after treatment for a patient participating in the study are included below.

Vitiligo Patient Pre- and Six-Months Post Treatment

 

 

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Baseline (pre-treatment)        Six months after treatment

Similar results were described by researchers in a publication in the British Journal of Dermatology in November 2017. In addition to studies which have already been the subject of peer-reviewed publication, the RECELL System has been used extensively in the treatment of vitiligo patients in countries in which the product is approved for treatment, including China were the prevalence of vitiligo is high. In May 2019 use of the RECELL System in the treatment of vitiligo patients in China was the subject of two presentations at a European medical conference. We plan to commence U.S. clinical trials of the use of the RECELL System for the treatment of stable vitiligo under a program designed to support a supplement to the existing PMA approval.

The RECELL System Clinical History in Chronic Wounds

Small pilot studies using the RECELL System in the treatment of chronic wounds, particularly venous leg ulcers and diabetic foot ulcers, have been the subject of multiple peer-reviewed scientific publications and presentations at medical conferences. In addition to studies which have already been the subject of peer-reviewed publication, the RECELL System has been used in the treatment of chronic wound patients in countries in which the product is approved for treatment. A study published in the Acta Vulnologica in September 2012 included seven patients with 12 vascular ulcers which had remained open for more than 12 months. Each wound was prepared and then treated with Spray-On Skin Cells prepared using the RECELL System. Ulcer volume and depth decreased 50% to 80% within four weeks of treatment, and six of the wounds that had remained unhealed

 

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for more than one year were completely closed within 24 weeks of treatment. Researchers concluded that treatment with the RECELL System allowed the repair process to restart in all 12 wounds, and that patients reported reduced pain within days of treatment.

In a study published in the British Journal of Surgery in January 2015, 88 patients with chronic wounds that had not healed for at least four weeks were evaluated. Patients were randomized to receive treatment with the combination of Spray-On Skin Cells and split-thickness autografts, or autografts alone. Results of the randomized, controlled study were as follows:

 

   

Incidence of complete wound healing in the group of patients treated using the RECELL System was significantly higher (p=0.035) than in the control group (41 versus 34, respectively)

 

   

Time to healing was significantly (p=0.001) shorter in the RECELL System group versus control (14 versus 20 days, respectively)

 

   

Fewer complications (p=0.047) were seen in the RECELL System group versus control (4 versus 11, respectively)

 

   

The RECELL System group had good elasticity and texture, similar color, and less scar tissue growth at borders versus control group

 

   

Scarring was significantly less (p=0.005) in the RECELL System group versus control

 

   

Patients had no recurrent ulcers in the RECELL System group but there were three new wounds in control group (one diabetic wound, one pressure wound, and one vascular wound). Secondary surgical intervention was required for these patients.

Researchers concluded that the combination of Spray-On Skin Cell and autografts is more effective and safer than autografts alone. Although the study involved treatment of a mix of chronic wounds, many were diabetic foot ulcers. The researchers suggest that the results show a broad range of potential applicability for the use of the RECELL System.

In a study published in the International Wound Journal in February 2015, 20 patients with chronic ulcers were evaluated in a single arm study. Patients participating in the study had arterial, diabetic, posttraumatic, or venous ulcers that had failed to heal after treatment with conventional therapies. Each wound was prepared and then treated with Spray-On Skin Cells prepared using the RECELL System. Within 60 days of treatment, 70% of the patients experience complete healing of their wounds. Five of the patients had 80% healing of their wounds within 60 days of treatment, and one patient at 50% healing at that time point. Patients also experienced a reduction in pain post treatment using the RECELL System and experienced no limitation in their ability to engage in normal daily activities. Color, texture and aesthetics results were rated as good. Researchers concluded that use of the RECELL System in the treatment of chronic wounds is simple minimally invasive, biocompatible and effective.

Due to the significant costs and risks of conducting larger-scale, late-stage clinical trials in the treatment of chronic wounds, we may elect to proceed with development of the RECELL System in more advanced clinical trials under the umbrella of a corporate collaboration to allow for participation in any future commercial success of the program while minimizing near-term resource requirements.

The RECELL System in Trauma Injuries (Soft-Tissue Injuries)

Case studies the use of the RECELL System in the treatment of trauma injuries (soft-tissue wounds) have been the subject of peer-reviewed scientific publications and presentations at medical conferences that cover a wider range of injuries or wounds of the skin. Patients with trauma injuries have also been treated using the RECELL System under the U.S. Compassionate Use program and in countries in which the product is approved for treatment. We plan to commence in 2019 a U.S. clinical trial of the use of the RECELL System for the treatment of trauma wounds under a program designed to support a supplement to the existing PMA approval.

 

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The RECELL System in Other Indications

We expect to explore potential benefits of variants of the RECELL System platform in aesthetics markets, and as part of this initiative has exploratory programs underway in certain orphan diseases, such as epidermolysis bullosa and Hutchinson-Gilford progeria syndrome (HGPS).

BARDA Contract

We have a contract with Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, valued at least US$50.4 million (approximately A$68.14). The contract provides funding for the development of the RECELL System and future use of the product as a medical countermeasure to assist disaster preparedness and response in the U.S. for mass casualties involving burn injuries. We entered into the contract on September 29, 2015, and the scope was expanded as a result of amendments entered into as of June 24, 2016 and September 18, 2017. The contract terminates September 28, 2022 and may be terminated earlier at the option of BARDA.

Under the contract, BARDA provide funding and technical support for the development of the RECELL System. BARDA funded the completion of two randomized, controlled pivotal clinical trials, as well as Compassionate Use and Continued Access programs, and development of the health economic model demonstrating the cost savings associated with the RECELL System. BARDA has exercised a contract option to fund two randomized, controlled clinical trials in pediatric patients. The pediatric donor site study commenced in October 2018 and the pediatric early intervention study will commence in late 2019. Also included in the BARDA contract is provision for the future procurement of the RECELL System by BARDA under a vendor managed inventory system to bolster, at BARDA’s option, disaster preparedness in the amount of US$7.6 million (approximately A$10.3 million), although BARDA also has the option of increasing the amount of the procurement. In connection with the BARDA contract, we anticipate that with respect to vendor-managed inventory systems, our margins may be lower. As the vendor-managed system is solely at BARDA’s option, we are unable to predict when the Company will recognize revenue on this portion, if at all. As of December 31, 2018, we had received cumulative payments of A$22.6 million under the BARDA contract.

Research and Development

Our research and development efforts are focused on:

 

   

Further clinical development of the RECELL System in additional indications such as pediatric burns, treatment of donor sites, trauma wounds and vitiligo.

 

   

Further research and characterization of the characteristics of the RECELL System, the composition and activity of the Spray-On Skin Cells suspension, and the design of the device to support further development of the platform in other injuries and defects of the skin, and to expand the existing intellectual property estate.

 

   

Expansion of the technology platform underlying the RECELL System, including combining the platform with other technologies, to allow development of the platform in other indications including orphan indications.

See “ITEM 4, Clinical Results and Ongoing and Planned Clinical Trials” for additional details on our ongoing research and development efforts.

Manufacturing, Supply and Production

We operate a production plant in Ventura, California, in a 23,040 square foot facility that we lease through September 30, 2021. We have the right to extend the lease, at our sole option, as a result of three, three-year,

 

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options that allow us to extend the lease up to an additional nine years in total. We produce the RECELL System in this facility under the current Good Manufacturing Practices (cGMP) requirements of the FDA and the regulatory agencies of other jurisdictions in which we sell the RECELL System. As we seek regulatory approval in Japan and other new international countries for the RECELL System, the regulatory authorities of these counties are likely to review our manufacturing process, inspect our plant, and confirm that we meet all regulatory requirements. Any material future changes to our production processes for the RECELL System will have to be approved by the FDA and regulatory authorities in other jurisdictions.

All production requirements for the RECELL System, including devices required for U.S. and international sales and clinical trial requirements, have been manufactured at the Ventura facility since 2009. Up until June 30, 2018, the RECELL System was produced in the Ventura facility on our behalf by a Fortune 500 contract manufacturer who produced multiple GMP products for third parties. Due to a consolidation of facilities by the contract manufacturer, effective July 1, 2018 we entered into a series of agreements to take control of the Ventura plant, lease the facility, and acquire manufacturing equipment from the contract manufacturer at no cost.

Within the Ventura facility we perform the final manufacturing, assembly, packaging and warehousing of the RECELL System. Also included within the Ventura facility is a controlled warehouse designed to meet the vendor-managed inventory requirements of the BARDA program. We source multiple components, sub-assemblies and materials from third-party suppliers, who are required to meet our quality specifications. Included among the items procured from suppliers is porcine-derived trypsin, which is the enzyme key to the skin cell disaggregation performed using the RECELL System. Although we endeavor to have multiple sources of supply for key components, subassemblies and materials, some are procured from single source suppliers. We continue to evaluate methods of removing risk from the supply chain for the RECELL System, including ultimately moving to a recombinantly produced Trypsin.

We believe that our current manufacturing capacity at the Ventura facility is sufficient to meet the expected commercial demand for the RECELL System for burns and other indications currently under development.

Marketing Sales and Distribution

We sell the RECELL System in the U.S. through our own commercial organization consisting of 20 field sales personnel (consisting of Regenerative Tissue Specialists, Clinical Training specialists and regional managers). and the field sales team is supported by centralized marketing, reimbursement, sales operations and leadership personnel, and also receives clinical and scientific support from our Medical Affairs team. The field sales team was recruited and hired subsequent to the September 2018 FDA approval and were trained prior to our U.S. market launch of the RECELL System in January 2019. All of our field sales personnel have prior experience in the U.S. burn market and in the launch of new products. Each of the clinical training specialists responsible for training the surgeons and other medical personnel within the burn centers are experienced burn nurses.

The market for the treatment of burns in the U.S. is highly concentrated, with 134 burn centers and approximately 300 burn surgeons. Accordingly, we believe that our sales organization is of an appropriate size to reach the burn surgeons and other key decision makers associated with our initial target market of patients with burn injuries of 10% or greater TBSA treated on an in-patient basis within U.S. burn centers. As a result of the concentrated nature of the U.S. burn market, we do not have an external distribution or warehousing structure and ship the RECELL System directly from our Ventura facility to U.S. burn centers.

The objective of our field sale team is to build upon burn community awareness resulting from the extensive series of burn conference presentations and scientific publications to further expand the interest in clinical and economic benefits of the RECELL System among burn surgeons and other professionals who are not already experienced with the product. In addition, we have set a policy of not providing the RECELL System to a burn center or other institution until their site has been certified by us, which includes training in the use of the product

 

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and in the proper aftercare of the patient. Training of the burn sites is undertaken by the clinical training specialist component of our sales team, augmented from personnel by our Medical Affairs team. In general, we expect most U.S. burn centers will follow the industry standard process of evaluating the RECELL System and then taking it through their hospital’s Value Analysis Committees (VAC) prior to purchasing the product. This process can sometimes be a lengthy one taking six months to complete. As a result of the training requirements and the VAC process, we expect that the adoption of the RECELL System among U.S. burn centers will occur on a staggered basis over multiple years.

In the U.S., hospital and physician reimbursement associated with in-patient treatment using the RECELL System was in place prior to the commencement of commercial sales. For in-patient treatment of burn patients, U.S. hospitals are reimbursed under ICD-10 (International Classification of Diseases, Tenth Revision, Clinical Modification) codes based on diagnosis of a patient’s injuries. For physicians, CPT (Current Procedural Terminology) codes for use in procedures using the RECELL System were recommended by the American Burn Association within one week of FDA approval. Future expansion, based on additional clinical data and subject to a supplement to our PMA, of the use of the RECELL System for the treatment of burns or other indications on an outpatient basis will require us to successfully obtain reimbursement for use of the product in that setting.

In February 2019 we entered into a collaboration with COSMOTEC, an M3 Group company, to market and distribute the RECELL System for the treatment of burns and other wounds in Japan. In China we have relied upon a series of one-year distributorships to allow awareness of the product to build while maintaining flexibility to undertake an alternative commercialization strategy as data to support the approval and use of the RESELL System in other indications becomes available. Our commercialization efforts in other regions in which the RECELL System is approved for sale is based on our assessment that the acute burn market in many countries is proportionately less than the market in the U.S., and the investments in a full marketing and sales resources and the effort to obtain reimbursement are not justified until we have obtained pivotal clinical results in additional indications. In Australia and Europe for the past year we have not engaged in any substantial promotion of the RECELL System but have limited our commercialization efforts to filing sales orders as received. As additional pivotal trial data for the RECELL System is generated in additional indications, we expect to commercialize the product in countries outside the U.S. through a combination of collaborations and direct efforts, depending upon the territory and the indication.

Intellectual Property

We seek to protect our intellectual property, core technologies and other know-how through a combination of patents, trademarks, trade secrets, non-disclosure and confidentiality agreements, licenses, assignments of invention and other contractual arrangements with our employees, consultants, partners, suppliers, customers and others. Additionally, we rely on our research and development program, clinical trials, know-how and marketing and distribution programs to advance our products and product candidates, and to expand our intellectual property rights. As of December 31, 2018, we have been granted a total of a total of 32 patents and have 15 pending patent applications worldwide.

The U.S. patents and patent applications provide coverage with expected expiration dates ranging from 2022 to 2033. U.S. patents covering the composition of matter related to the current RECELL System expire in 2022. We have filed a Patent Term Extension (PTE) application with the U.S. Patent and Trademark Office requesting an extension of the patent term of U.S. Patent No. 9,029,140, “Cell suspension preparation technique and device” as a result of the time required for the FDA regulatory process. If the term extension requested in the PTE application is approved, the patent term of U.S. Patent No. 9,029,140 will be extended to 2028. We expect that further research and characterization of the characteristics of the RECELL System, the composition and activity of the Spray-On Skin Cells solution, and the design of the device currently underway will provide additional claims, including composition of matter, for which we will be able to pursue additional U.S. and international patent applications. Patents and patent applications in key international markets parallel those in the U.S.

 

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In addition to patent protection, we also rely on trade secrets, including unpatented know-how, technology innovation, drawings, technical specifications and other proprietary information in attempting to develop and maintain our competitive position. We also rely on protection available under trademark laws, and we currently hold various registered trademarks and pending trademark applications, including the “RECELL,”,” “Spray-On Skin Cells,” and “REGENERATIVE EPIDERMAL SUSPENSION (RES),” in the U.S. and international markets.

While our policy is to obtain patents by application, license or otherwise, to maintain trade secrets and to seek to operate without infringing on the intellectual property rights of third parties, technologies related to our business have been rapidly developing in recent years. Additionally, patent applications that we may file or license from third parties may not result in the issuance of patents, and our issued patents and any issued patents that we may receive in the future may be challenged, invalidated or circumvented. For example, we cannot predict the extent of claims that may be allowed or enforced in our patents nor be certain of the priority of inventions covered by pending third-party patent applications. If third parties prepare and file patent applications that also claim technology or therapeutics to which we have rights, we may have to participate in proceedings to determine priority of invention, which could result in substantial costs to us, even if the eventual outcome is favorable to us. Moreover, because of the extensive time required for clinical development and regulatory review of a product we may develop, it is possible that, before the RECELL System can be commercialized in additional indications or jurisdictions and/or before any of our future products can be commercialized, related patents will have expired or will expire a short period following commercialization, thereby reducing the advantage of such patent. Loss or invalidation of certain of our patents, or a finding of unenforceability or limited scope of certain of our intellectual property, could have a material adverse effect on us. See “ITEM 3.D. Risk Factors – If we are unable to effectively protect our intellectual property, we may not be able to operate our business and third parties may be able to use and profit from our technology, both of which would impair our ability to be competitive.”

Competition

The medical device, biotechnology and pharmaceutical industries are intensely competitive and subject to significant technological change and changes in practice. While we believe that our innovative technology, knowledge, experience and scientific resources provide us with competitive advantages, we may face competition from many different sources with respect to the RECELL System or any product candidates that we may seek to develop and commercialize in the future. Possible competitors may include medical device, pharmaceutical and wound care companies, academic and medical institutions, governmental agencies, medical practitioners, and public and private research institutions, among others. Any product that we successfully develop and commercialize will compete with existing therapies and new therapies that may become available in the future.

In addition, in the treatment of acute burns we face competition from the current standard of care, primarily split-thickness autografts. Although the RECELL System is complementary with autografts for the treatment of many burn injuries, we face competition from this traditional surgical procedure for many burn patients. However, based on our clinical trials, we believe that the RECELL System has a sustainable competitive clinical and economic advantages over the current standard of care. See “ITEM 4 – The RECELL System Clinical History and Ongoing and Planned Clinical Trials” for the results of our clinical trials.

Government Regulations

FDA and International Regulation

The production and marketing of the RECELL System and any additional product candidates developed in the future ongoing research and development activities are subject to regulation by numerous governmental authorities including the FDA in the United States and similar agencies in other countries throughout the world.

 

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Pursuant to its authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) the FDA has jurisdiction over medical devices in the U.S. The FDA regulates, among other things, the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion and sales and distribution of medical devices in the U.S. to ensure that medical products distributed domestically are safe and effective for their intended uses. The FD&C Act classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable assurance of safety and effectiveness. Devices deemed by the FDA to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices, or devices deemed not substantially equivalent to a previously 510(k) cleared device are categorized as Class III. These devices typically require submission and approval of a Premarket Approval Application, or PMA. The RECELL System is categorized as a Class III medical device, and in September 2018 the FDA approved our PMA for use in the treatment of acute thermal burns in patients 18 years and older. Approval of the RECELL System for use in the treatment of additional indications in the U.S. will require the submission to the FDA of a supplement to our PMA.

To support a PMA supplement or other application for approval in the U.S. or other regions, the completion of additional clinical and non-clinical studies and supporting development activities will likely be required. Clinical trials can take many years to complete and require the expenditure of substantial resources. The length of time varies substantially according to the type, complexity, novelty and intended use of the product candidate. We cannot make any assurances that once clinical trials are completed by us or a collaborative partner, we will be able to submit as scheduled a marketing approval request to the applicable governmental regulatory authority, or that such request and application will be reviewed and cleared by such governmental authority in a timely manner, or at all. Although we intend to make use of fast-track and abbreviated regulatory approval programs when possible and commercially appropriate, we cannot be certain that we will be able to obtain the clearances and approvals necessary for clinical testing or for manufacturing and marketing our product candidates. Delays in obtaining regulatory approvals could adversely affect the development and commercialization of our product candidates and could adversely impact our business, financial condition and results of operations. During the course of clinical trials and non-clinical studies, product candidates may exhibit unforeseen and unacceptable safety considerations. If any unacceptable side effects were to occur, we may, or regulatory authorities may require us to, interrupt, limit, delay or abort the development of our potential products.

Any products manufactured or distributed by us pursuant to regulatory approvals are subject to continuing regulation by the FDA and similar agencies in other countries, including manufacturing, periodic reporting, product sampling and distribution, advertising, promotion, compliance with any post-approval requirements imposed as a conditional of approval, recordkeeping and reporting requirements, including adverse events experiences. After approval, material changes to the approved product, such as adding new indications or other labeling claims, or changes to the manufacturing process, are subject to prior FDA and other agency review and approval. Medical device manufacturers and their subcontractors are required to register their establishments with the FDA, certain state agencies and international agencies and are subject to periodic announced and unannounced inspections by the FDA and these other agencies for compliance with cGMP requirements. We have an established process in place for categorization of vendor criticality and the associated activities for qualification and monitoring, which include but are not limited to, requiring certification of supplier in conformance to relevant cGMP regulations and other FDA and international agency regulatory requirements, approved supplier lists, and regular Company conducted audits. In addition, all goods and services purchased from suppliers by us must be purchased from only those suppliers on the approved supplier list. Furthermore, the Company itself will continue to comply with all relevant FDA requirements and regulations and any applicable international agency regulatory requirements in its continued manufacturing and promotion of its FDA approved commercial product.

The RECELL System is TGA-registered in Australia and CFDA-cleared in China for use in the treatment of burns, acute wounds, scars and vitiligo. In Europe, the RECELL System received CE-mark approval for the treatment of burns, chronic wounds, scars and vitiligo. In March 2019 we temporarily interrupted sales of the

 

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RECELL System in the EU. The sales interruption occurred after the notified body responsible for EU certificates reported open items related to administrative and procedural non-conformities. These open items are limited to product distributed within the EU and are not related to product quality, performance or safety. While the temporary non-conformity caused us to suspend fulfilling any purchase requests in the EU, this action had no impact on the sale of products outside of the EU. We do not actively promote the products in the EU and its activity in the region is limited to filling purchase requests as they are received, therefore the financial impact to us of this temporary interruption was immaterial. On June 12, 2019, the notified body responsible for EU certificates closed all open administrative and procedural non-conformities previously announced and fully reinstated our EU certificates to allow the resumption of sales throughout the EU. In February 2019, our marketing partner COSMOTEC filed a Japan’s Pharmaceuticals and Medical Devices Act (“JPMDA”) application for approval to market the RECELL System in Japan for the treatment of burns and other wounds. The JPMDA has accepted the application and review is expected to take nine months to a year.

The Foreign Corrupt Practices Act

The Foreign Corrupt Practices Act, or FCPA, prohibits any U.S. individual or business from paying, offering or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the companies to maintain books and records that accurately and fairly reflect all transactions of the companies, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations. We are also subject to similar regulations under the Australian bribery laws and the U.S. Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws that apply in countries where we do business.

Environmental, Health and Safety Matters

We are subject to extensive environmental, health and safety laws and regulations in a number of jurisdictions, primarily in the United States, governing, among other things: the use, storage, registration, handling, emission and disposal of chemicals, waste materials and sewage; chemicals, air, water and ground contamination; air emissions and the cleanup of contaminated sites, including any contamination that results from spills due to our failure to properly dispose of chemicals, waste materials and sewage. Our operations at our Ventura manufacturing facility use biologic agents and produce waste materials and sewage. Our activities require permits from various governmental authorities including, local municipal authorities. Local authorities and the municipal water and sewage company conduct periodic inspections in order to review and ensure our compliance with the various regulations. We are no presently aware of any violations or deficiencies. These laws, regulations and permits could potentially require the expenditure by us for compliance or remediation.

If we fail to comply with such laws, regulations or permits, we may be subject to fines and other civil, administrative or criminal sanctions, including the revocation of permits and licenses necessary to continue our business activities. In addition, we may be required to pay damages or civil judgments in respect of third-party claims, including those relating to personal injury (including exposure to hazardous substances we use, store, handle, transport, manufacture or dispose of), property damage or contribution claims. Some environmental, health and safety laws allow for strict, joint and several liability for remediation costs, regardless of comparative fault. Should we be in violation of any such laws, we may be identified as a responsible party under such laws. Such developments could have a material adverse effect on our business, financial condition and results of operations. In addition, laws and regulations relating to environmental, health and safety matters are often subject to change. In the event of any changes or new laws or regulations, we could be subject to new compliance measures or to penalties for activities which were previously permitted.

 

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Legal and Administrative Proceedings

We are not party to any material legal or administrative proceedings, and we are not aware of any threatened material legal or administrative proceedings against us.

C. Organizational Structure

We have a total of five subsidiaries and their corporate details and business activities are listed below:

 

Subsidiary Name    Place of Incorporation    % held    Business scope
Avita Medical Americas, LLC    Delaware    100    U.S. operations
Avita Medical Europe Limited    United Kingdom    100    EMEA operations
Visiomed Group Pty Ltd    Australia    100    Asia Pacific Operations
C3 Operations Pty Ltd    Australia    100    Holding company
Infamed Pty Ltd    Australia    100    Inactive

D. Property, Plant and Equipment

Our principal corporate offices are located at 28159 Avenue Stanford, Suite 220, Valencia, California 91355. We lease the 17,481 facility under two lease agreements that, as amended, expire on January 31, 2021 with the right to extend the leases, at our sole option, for an additional three-years. Our production plant in Ventura, California, is a 23,040 square foot facility that we lease through September 30, 2021 with the right to extend the lease, at our sole option, as a result of three, three-year, options that allow us to extend the lease up to an additional nine years in total.

ITEM 4A. UNRESOLVED STAFF COMMENTS

None.

ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS

Special Note Regarding Forward Looking Statements

The following discussion and analysis include certain forward-looking statements with respect to the business, financial condition and results of operations of our company. The words “estimate,” “project,” “intend,” “expect” and similar expressions are intended to identify forward- looking statements within the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated by such forward-looking statements, including those risk factors contained in Item 3.D. of this Registration Statement. You should read the following discussion and analysis in conjunction with our consolidated financial statements and the notes thereto included in this Registration Statement.

Background

Avita Medical Limited and our subsidiaries Avita Medical Americas, LLC, Avita Medical Europe Limited, Visiomed Group Pty Ltd, C3 Operations Pty Ltd and Infamed Pty Ltd, which we collectively refer to as the “Company,” is a regenerative medicine company with a technology platform designed to address unmet medical needs in patients with burns, chronic wounds, and aesthetics indications. Our patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. Our lead product, the RECELL® System, uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes. This autologous suspension of skin cells is then sprayed onto the areas of the patient requiring treatment. The RECELL System, was approved for

 

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sale in the U.S. for the treatment of acute thermal burns in patients 18 years and older by the Food and Drug Administration (FDA) in September 2018. We initiated our U.S. national market launch of the RECELL System in January 2019, although it did commence commercial shipments in the U.S. during the half-year ended December 31, 2018 in response to pre-launch demand from burn centers. During the year ended June 30, 2018 and the half-year ended December 31, 2018, the RECELL System was also sold on a limited basis in certain regions of the world in which the products were approved for sale, including Australia, China and Europe.

We believe that there are many factors and trends that may effect our financial condition and results of operations. Primarily and foremost, our revenue growth will be impacted most by market acceptance, adoption and penetration of our RECELL System. In addition, the Company is always pursuing expansion of labeling additional indications that could open new markets such as the treatment of leg and foot ulcers, vitiligo, chronic wounds and trauma injuries.

In this Registration Statement, all references to “U.S. dollars” or “US$” are to the currency of the U.S., and all references to “Australian dollars”, “A$” or “AUD$” are to the currency of Australia.

For a description of the milestones that we have achieved since inception and through to the date of this report, see “Item 4. Information on the Company – A. History and Development of the Company.”

Critical Accounting Policies

Our consolidated financial statements appearing in this registration statement on Form 20-F are prepared in Australia dollars in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this registration statement on Form 20-F comply with IFRS. As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available. These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The significant accounting policies listed in Note 2 to the consolidated financial statements that our management believes are the most critical to aid in fully understanding and evaluating our financial condition and results of operations under IFRS are discussed below.

Revenue Recognition

Revenue is recognized and measured at the fair value of the consideration received or receivable to the extent it is probable that the economic benefits will flow to the Company and the revenue can be reliably measured. The following specific recognition criteria must also be met before revenue is recognized:

Sale of Goods

Revenue from the sales of goods is recognized at a point in time when the Company satisfies performance obligations by transferring the promised goods to its customers. The Company recognizes contract liabilities for consideration received in respect of unsatisfied performance obligations and reports these amounts as other liabilities in the statement of financial position. Similarly, if the Company satisfies a performance obligation before it receives the consideration, the Company recognizes either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due.

BARDA Income

The Company had been granted a BARDA contract in September 2015, wherein BARDA funded the Company to support the ongoing U.S. clinical regulatory program towards FDA Premarket Approval and

 

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Compassionate Use program, and clinical and health economics research in U S. pediatric burn care. BARDA income is recognized in the income statement when it is probable that the Company will receive the economic benefits of the contract and the amount can be reliably measured. The BARDA contract allows the Company to be reimbursed for costs incurred to fund the programs outlined above. The BARDA funds received are recognized in the period that the costs are incurred by the project.

Interest Income

Revenue is recognized as interest accrues using the effective interest method.

Share-based payments

The Company provides benefits to our employees (including executive management) in the form of share-based payments, whereby employees render services in exchange for shares or rights over shares (equity-settled transactions).

The Company has in place two employee share option plans which provide benefits to employees and are eligible to provide benefits to directors. The cost of these equity-settled transactions with employees is measured by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by an external valuation firm using a binomial model. The cost of equity-settled transactions is recognized, together with a corresponding increase in equity, over the period in which the performance and/or service conditions are fulfilled (the vesting period), ending on the date on which the relevant employees become fully entitled to the award (the vesting date).

At each subsequent reporting date until vesting, the cumulative charge to profit or loss is the product of:

 

   

the grant date fair value of the award;

 

   

the current best estimate of the number of awards that will vest, taking into account such factors as the likelihood of employee turnover during the vesting period and the likelihood of non-market performance conditions being met; and

 

   

the expired portion of the vesting period.

The charge to profit or loss for the period is the cumulative amount as calculated above less the amounts already charged in previous periods. There is a corresponding entry to equity.

The expense recognized by Avita Medical Limited for equity-settled awards only represents the expense associated with grants to employees of Avita Medical Limited, whereas the expense recognized by the Company is the total expense associated with all such awards.

Until an award has vested, any amounts recorded are contingent and will be adjusted if more or fewer awards vest than were originally anticipated to do so.

If the terms of an equity-settled award are modified, as a minimum, an expense is recognized as if the terms had not been modified. An additional expense is recognized for any modification that increases the total fair value of the share-based payment arrangement or is otherwise beneficial to the employee, as measured at the date of modification.

If an equity-settled award is cancelled, it is treated as if it had vested on the date of cancellation, and any expense not yet recognized for the award is recognized immediately. However, if a new award is substituted for the cancelled award and designated as a replacement award on the date that it is granted, the cancelled and new award are treated as if they were a modification of the original award, as described in the previous paragraph.

 

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The dilutive effect, if any, of outstanding options, is reflected as additional share dilution in the computation of diluted earnings per share.

Research and Development Payments

Expenditures during the research phase of a project are recognized as expenses when incurred. Development costs are capitalized only when technical feasibility studies identify that the project is expected to deliver future economic benefits and these benefits can be measured reliably.

Capitalized development costs have a finite useful life and amortized on a systematic basis based on the future economic benefits over the useful life of the project.

Research and Development Tax Incentive

The Company’s research and development activities are eligible under an Australian Government tax incentive for eligible expenditure from 1 July 2012. Management has assessed these activities and expenditure to determine which are likely to be eligible under the incentive scheme. For the years ended June 30, 2018, 2017 and 2016, the Company recorded other income of A$1,385,796, A$1,048,237 and A$971,881, respectively related to recognition of this tax incentive. The Australian R&D tax incentive scheme permits overseas activity to be claimed to the extent that the overseas activity does not exceed 50% of the total costs of activities for an eligible project. As of December 31, 2018, the Company evaluated the level overseas activity and concluded there was uncertainty as to the ability to meet this criteria. Additionally, at that time, the Federal Budget included a number of changes to the R&D tax incentive scheme which would place further limits on claimable amounts. These budget changes have since been formally placed on hold. In consideration of these uncertainties, no amounts were accrued for as at December 31, 2018.

Internal Controls

A material weakness was identified in our internal control over financial reporting relating to the application of tax legislation across jurisdictions, specifically our controls over tracking and monitoring the disclosures related to accumulated tax losses by jurisdiction.

We are taking steps to remediate this deficiency. We intend to implement a more rigorous process to track and monitor our accumulated tax losses and we have hired an external income tax specialist to review our application of tax legislation across jurisdictions. We believe that the above actions will be effective in remediating the material weakness described above. However, the material weakness cannot be considered remediated until the controls operate for a sufficient period of time and management has concluded, through testing, that our internal controls are operating effectively.

Any future failure to maintain such internal controls could adversely impact our ability to report our financial results on a timely and accurate basis, which could result in our inability to satisfy our reporting obligations or result in material misstatements in our financial statements. If our financial statements are not accurate, investors may not have a complete understanding of our operations or may lose confidence in our reported financial information, which could result in a material adverse effect on our business or have a negative effect on the trading price of our ordinary shares and ADRs.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations for the years ended June 30, 2018, 2017 and 2016 and the half-year ended December 31, 2018 and 2017, should be read in conjunction with our consolidated financial statements and related notes included in this registration statement in accordance with “Item 8. Financial Information”. In addition, Exhibit 15.1 included with this registration

 

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statement on Form 20-F contains the preliminary, unaudited consolidated statements of profits or loss and other comprehensive income, consolidated statements of financial position, consolidated statements of cash flows and consolidated statements of changes in equity for the fiscal year ended June 30, 2019 as submitted as Appendix 4E in connection with the ongoing listing of our ordinary shares on the Australian Securities Exchange. The results presented in Exhibit 15.1 are preliminary in nature, have not been audited, and are subject to change and should not be relied on as indicative of actual results for the year ended June 30, 2019.

Year Ended June 30, 2018 compared to Year Ended June 30, 2017

Sale of goods of the RECELL devices totaled A$1,198,861 for the year ended June 30, 2018, an increase of A$297,485 or 33% over the A$901,376 recognized during fiscal 2017. The largest increase in sale of goods occurred in Asia Pacific which accounted for 59% of total commercial sales, while the sale of goods in EMEA comprised the remaining 41% of total commercial sales. Gross margins for the years ended June 30, 2018 was 57% compared to 49% for the same period in 2017, and we expect gross margins to further increase as sales ramp up within the U.S.

We believe that there are many factors and trends that may effect our financial condition and results of operations. Primarily and foremost, our revenue growth will be impacted most by market acceptance, adoption and penetration of our RECELL System. Pricing is not expected to be a significant factor in connection with our revenue growth. In addition, the Company is always pursuing expansion of labeling additional indications that could open new markets such as the treatment of leg and foot ulcers, vitiligo, chronic wounds and trauma injuries. With regard to the foregoing factors and additional indications, we believe that over the next several years, the most critical component of our changes of sales of goods will be market acceptance and adoption of the RECELL System for burns, followed by approval, market acceptance, adoption of the additional, and potentially other, indications noted above. We do not consider pricing to be a critical component of revenue growth, instead, as indicated above, market acceptance, adoption and penetration of the RECELL System would have a material effect on our sales of goods.

Other income totaled A$10,172,698 for the year ended June 30, 2018, an increase of A$2,941,728 or 41% over the A$7,230,970 recognized during fiscal 2017. The majority of other income consisted of funding from the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services. Under the BARDA contract, income of A$10,104,081 was recognized during the year ended June 30, 2018 compared to income of A$6,886,236 for fiscal 2017. This increase was the result of an expansion of activities related to programs conducted under the BARDA contract during the year. Funding provided by BARDA during the year ended June 30, 2018 focused primarily on support of the U.S. PMA application for the RECELL System, the Continued Access and Compassionate Use programs which provide access to the RECELL System for U.S. patients while the PMA is under review, and development of a health economic model by a major health care information and technology provider to quantify the economic value of the RECELL System versus standard of care for the treatment of severe burns.

As the result of investments in commercial, manufacturing, leadership and system capabilities in preparation for the planned U.S. launch of the RECELL System and related research and development and corporate initiatives including the BARDA programs, operating expenses increased during the year ended June 30, 2018. Sales and marketing expenses totaled A$8,936,441, an increase of A$3,734,680 or 72% over the A$5,201,761 recognized during fiscal 2017. Product development expenses totaled A$12,606,127 an increase of A$1,444,157 or 13% over the A$11,161,970 recognized during fiscal 2017. Corporate and administrative expenses totaled A$5,360,553 for the year ended June 30, 2018, an increase of A$3,095,959 or 137% over the A$2,264,594 recognized during fiscal 2017. Total operating costs totaled A$28,764,864, an increase of A$8,536,542 or 42% over the A$20,228,322 recognized during fiscal 2017 and were in line with management expectations.

We recorded a foreign exchange gain of A$563,279 for the year ended June 30, 2018, compared to a foreign exchange loss of A$83,293 for the year ended June 30, 2017. Foreign exchange gain (loss) reflects the impact of changes in foreign currency exchange rates on cash and cash equivalents that we hold in U.S. dollars, and to a

 

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smaller extent in British Pounds and Euros. In 2018, the Australian dollar depreciated against the U.S. dollar, which had a favorable impact on the Australian dollar value due to the fact that the majority of our cash and cash equivalents were held in U.S. dollars. In 2017, the Australian dollar depreciated against the U.S. dollar, which had an unfavorable impact on the Australian dollar value due to the fact that the majority of our cash and cash equivalents were held in Australian dollars.

The net comprehensive loss after tax benefit for the year ended June 30, 2018 was A$15,955,876, an increase of A$4,096,298 or 35% over A$11,859,578 recognized during fiscal 2017. The increase in net comprehensive loss was driven by the higher operating costs described above, partially offset by the higher sale of goods and BARDA income recognized during the year ended June 30, 2018. As the Company continues its preparations for the planned launch of the RECELL System in the U.S., operating expenses are expected to rise in future periods and will be offset in part by revenues under the BARDA contract as well as from sale of goods.

Year Ended June 30, 2017 compared to Year Ended June 30, 2016

Sale of goods of the RECELL devices totaled A$901,376 for the year ended June 30, 2017, a decrease of A$101,631 or 10% over the A$1,002,007 recognized during fiscal 2017. The decrease was primarily due to a decrease in EMEA operating segment promotional efforts and product sales during fiscal 2017. Gross margins for the year ended June 30, 2017 was 49% compared to 60% for the same period in 2016 primarily due to part of lower sales volumes in EMEA operating segment by 21%.

Other income was A$7,230,970 for the year ended June 30, 2017, an increase of 184% compared to A$2,544,517 recognized during fiscal 2016, as BARDA income of A$6,886,236 was received during the year as compared to the previous year’s BARDA income of A$2,424,357 which began in the third quarter of last year. The increase of BARDA income was due to the significant expansion of activities surrounding the Company’s Premarket Approval Application (PMA) submission to the FDA in September 2017 for approval to market the RECELL System in the U.S.

As the result of investments in clinical trials and preparation for and support of the PMA for the RECELL System, and related research and development and corporate initiatives including the BARDA programs, operating expenses increased during the year ended June 30, 2017. Product development expenses totaled A$11,161,970 an increase of A$5,143,786 or 86% over the A$6,018,184 recognized during fiscal 2016. Sales and marketing expenses were consistent year over year and totaled A$5,201,761, an increase of A$159,572 or 3% over the A$5,042,189 recognized during fiscal 2017. Corporate and administrative expenses were consistent and totaled A$2,264,594 for the year ended June 30, 2017, a decrease of A$107,153 or 5% over the A$2,371,747 recognized during fiscal 2016. In addition, share-based expense for the year ended June 30, 2017 included share-based expenses related to the resignation of the former CEO in May 2017 totaling A$1,189,021. This expense results from an acceleration of the recognition of non-cash expenses attributable to the initial valuation of the shares awarded under the CEO long-term, incentive agreement. Total operating costs totaled A$20,228,322, an increase of A$5,839,523 or 41% over the A$14,388,799 recognized during fiscal 2016 which were driven by the expanded operating activities noted above.

The net comprehensive loss after tax was A$11,859,578 an increase of A$4,177,724 or 54% over A$7,681,854 recognized during fiscal 2016. The increase in net loss was driven by higher operating costs described above, partially offset by higher revenue from BARDA. In addition, the prior year net comprehensive loss was reduced by a profit from discontinued operations (divestment of the respiratory business segment) of A$2,493,947.

Year Ended June 30, 2016 compared to Year Ended June 30, 2015

Sale of goods of the RECELL devices totaled A$1,002,007 for the year ended June 30, 2016, an increase of A$16,360 or 2% over the A$985,647 recognized during fiscal 2015. Gross margins for the year ended June 30,

 

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2016 was 60% compared to 71% for the same period in 2015. During this period the Company moved from a direct sale to a distributor sale model in most markets. While this did support the modest revenue growth over the previous fiscal year, there was a concurrent reduction in margin.

Other income was A$2,544,517 for the year ended June 30, 2016, an increase of 1,011% compared to A$228,988 recognized during fiscal 2015, as BARDA income of A$2,424,357 was received and began in the third quarter of fiscal year 2016 for the expansion of activities surrounding the Company’s PMA submission to the FDA in September 2017 for approval to market the RECELL System in the U.S.

As the result of investments in conduct of clinical trials and preparation for and support of the PMA for the RECELL System, and related research and development and corporate initiatives including the BARDA programs, operating expenses increased during the year ended June 30, 2016. Product development expenses totaled A$6,018,184 an increase of A$1,748,729 or 41% over the A$4,269,455 recognized during fiscal 2015. Sales and marketing expenses totaled A$5,042,189, an increase of A$349,555 or 7% over the A$4,692,634 recognized during fiscal 2015. Corporate and administrative expenses totaled A$2,371,747 for the year ended June 30, 2016, an increase of A$1,901,632 or 405% over the A$470,115 recognized during fiscal 2015. In addition, share-based expenses of A$956,658 for the year ended June 30, 2016 included a non-cash amount of A$902,959 which recognizes the appropriate valuation of the issuance of 40 million fully paid shares under the CEO Long Term Incentive Plan, announced on January 25, 2016, and which is subject to escrow and vesting conditions. The full valuation of the 40 million shares will be allocated over a five-year period as a non-cash expense. Total operating costs totaled A$14,388,799, an increase of A$4,943,244 or 52% over the A$9,445,555 recognized during fiscal 2015 which were driven by the expanded operating activities noted above.

The net comprehensive loss after tax was A$7,681,854 an increase of A$756,375 or 11% over A$6,925,479 recognized during fiscal 2015. The increase in net loss was driven by higher operating costs described above, partially offset by higher revenue from BARDA. In addition, the fiscal 2016 net comprehensive loss was reduced by a profit from discontinued operations (divestment of the respiratory business segment) of A$2,493,947 and a fair value gain on available for sale of financial assets of A$265,261.

Half-Year Ended December 31, 2018 Compared to Half-Year Ended December 31, 2017

Sale of goods of the RECELL devices totaled A$1,813,195 for the half-year ended December 31, 2018, an increase of A$1,205,434 or 198% over the A$607,761 recognized during the same period in 2017. The majority of the current-year increase in sales occurred in the U.S. as a result of the September 2018 FDA approval. U.S. sales during the half-year ended December 31, 2018 totaled A$1,101,991 compared to zero in the prior year. Gross margin for the half-year ended December 31, 2018 was 69% compared to 56% for the same period in 2017, and management expects gross margins to further increase as sales ramp up within the U.S.

Other income totaled $5,112,763 for the half-year ended December 31, 2018, an increase of A$1,218,452 or 31% over the A$3,894,311 recognized during same period in 2017. As in prior periods, the majority of other income consisted of funding from BARDA. Under the BARDA contract, income of A$5,009,137 was recognized during the half-year ended December 31, 2018 compared to income of A$3,856,716 during the same period in 2017. This increase was the result of an expansion of activities related to programs conducted under the BARDA contract during the year. Funding provided by BARDA during the half-year ended December 31, 2018 focused primarily on support of the regulatory activities to support the U.S. approval of the RECELL System, the Continued Access and Compassionate Use programs which provide access to the RECELL System for U.S. patients prior to FDA approval, and two U.S. clinical trials in pediatric burn patients.

Operations for the half-year ended December 31, 2018 were focused primarily on preparation for the January 2019 U.S. market launch of the RECELL System, including the recruitment, hiring and training of 20 sales field force personnel. Additional activities included the commencement of product shipments in the U.S. after the September 2018 FDA approval of the RECELL System for the treatment of acute thermal burns, and the

 

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preparation for, or the conduct of, further development of RECELL. As the result of investments in commercial, manufacturing, and system capabilities for the U.S. market launch of the RECELL System and related initiatives, operating costs for the half-year ended December 31, 2018 totaled A$21,935,034, a A$10,447,198 or 91% increase over the A$11,487,836 incurred during the same period in the prior year and were in line with management expectations. Sales and marketing expenses for the half-year ended December 31, 2018 totaled A$6,931,241, an increase of A$4,115,543 or 146% over the A$2,815,698 recognized during for first six months of fiscal 2017. Product development expenses for the 2018 half-year totaled $7,080,042 an increase of A$2,021,524 or 40% over the A$5,058,518 recognized during the first half of fiscal 2017. Corporate and administrative expenses totaled A$6,865,250 for the six months ended December 31, 2018, an increase of A$3,991,739 or 139% over the A$2,873,511 recognized during the first six months of fiscal 2017.

Net comprehensive loss after tax for the half-year ended December 31, 2018 was A$14,205,247, a A$6,899,260 or 94% increase compared to A$7,305,987 incurred in the same period in the prior half-year. The increase in net loss was driven by the higher operating costs described above, partially offset by the higher sale of goods and other revenue achieved during the six months. As a result of the national launch of the RECELL System in the U.S. in January 2019, and the expansion of research and development, operating expenses will increase in future periods. These expenses are expected to be partially offset by increased sales of goods and revenues under the BARDA contract.

B. Liquidity and Capital Resources

We expect to utilize cash reserves until U.S. and international sales of our products reach a level sufficient to fund ongoing operations. The Company has historically funded its research and development activities, and more recently its substantial investment in sales and marketing activities, through raising capital by issuing securities in the Company, and it is expected that similar funding will be obtained to provide working capital if and when required. If the Company is unable to raise capital in the future, the Company may need to curtail expenditures by scaling back certain research and development or other programs.

During the year ended June 30, 2018 and subsequent to year end, the Company completed a series of equity transactions totaling gross proceeds of A$74,775,545 which were used to fund operations. Of the total gross proceeds, A$29,760,645 was received from transactions completed during the year ended June 30, 2018, and A$45,014,900 was received from transactions completed subsequent to June 30, 2018.

On October 11, 2017, the Company completed a placement of 100,982,978 fully paid ordinary shares at a price of A$0.045 per share raising gross proceeds of A$4,544,234. On November 7, 2017, the Company completed a rights offering of 276,502,853 fully paid ordinary shares at a price of A$0.045 per share raising gross proceeds of A$12,442,628. On 6 June 2018, the Company completed the first tranche of an institutional placement in which it issued 255,475,665 fully paid ordinary shares at a price of A$0.050 per share raising gross proceeds of A$12,773,783. The institutional placement included a second tranche totaling A$3.250 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the Company issued 65 million shares at a price of A$0.050 per share and received gross proceeds of A$3,250,000 on July 26, 2018. Also subsequent to year end, on December 4, 2018, the Company completed the first tranche of an institutional placement in which it issued 310,047,015 fully paid ordinary shares at a price of A$0.080 per share raising gross proceeds of A$24,803,761. The institutional placement included a second tranche totaling A$15.196 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on January 14, 2019, and the Company issued 189,952,985 shares at a price of A$0.080 per share and received gross proceeds of A$15,196,239 on January 14, 2019. In addition, on January 11, 2019 the Company completed a Share Purchase Plan under which it issued 22,061,250 shares of stock at a price of A$0.080 per share and received gross proceeds of A$1,764,900.

The Company benefits from cash inflows from the BARDA contract, awarded to the Company in September 2015 and subsequently expanded through a series of modifications. These payments from BARDA offset costs

 

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from various activities undertaken to support the FDA regulatory approval process for RECELL in the U.S., preparation for the planned commercial launch of RECELL in the U.S., and RECELL clinical programs in the U.S. Further, there were no material expenditure commitments from the BARDA contract. With the U.S. FDA approval of RECELL for the treatment of burns in September 2019, and the U.S. market launch of the product in January 2019, sales of goods are expected to be an increasing source of revenue in the future. Another anticipated source of revenue for the Company is the BARDA contract covering the initial purchase, delivery and storage of RECELL devices in the amount of US$7,594,620 (approximately A$10.3 million).

The Company’s research and development activities are eligible under an Australian Government tax incentive for eligible expenditure from July 1, 2012. Our management has assessed these activities and expenditure and to determine our likely eligibility under this incentive scheme. For the half year ended December 31, 2018 and the years ended June 30, 2017 and 2016, the Company received A$2,440,803, A$972,283 and A$654,060 respectively related to this tax incentive.

The Australian R&D tax incentive scheme permits overseas activity to be claimed to the extent that the overseas activity does not exceed 50% of the total costs of activities for an eligible project. As of December 31, 2018, the Company evaluated the level overseas activity and concluded there was uncertainty as to the ability to meet this criteria. Additionally, at that time, the Federal Budget included a number of changes to the R&D tax incentive scheme which would place further limits on claimable amounts. These budget changes have since been formally placed on hold. In consideration of these uncertainties, no amounts were accrued for as at December 31, 2018. The Company does not believe any reduction over time of these potential payments to have a material effect on its liquidity or capital resources.

As a result, we believe there is sufficient working capital to support the committed research and development programs and other activities over the next 12 months and the Company has the ability to realize its assets and pay its liabilities and commitments in the normal course of business.

The following table summarizes our cash flows for the periods presented:

 

    As of June 30,     As of December 31,  

(In Australian dollars)

  2018     2017     2016     2018     2017  

Net cash used in operating activities

  A$ (16,372,024   A$ (8,557,524   A$ (7,938,557   A$ (10,458,479   A$ (7,875,025

Net cash (used in)/provided by investing activities

    (498,749     195,245       (47,849     (722,472     (63,672

Net cash provided by financing activities

    27,934,920       8,238,129       9,360,830       25,364,339       15,980,605  

Net increase/(decrease) in cash and cash equivalents

    11,064,147       (124,150     1,374,424       14,183,388       8,041,908  

Cash and cash equivalents at beginning of period

    3,790,491       4,171,879       2,966,555       14,825,532       3,790,491  

Impact of foreign exchange rate

    (29,106     (257,238     (169,100     1,333,440       (55,390

Cash and cash equivalents at end of period

    14,825,532       3,790,491       4,171,879       30,342,360       11,777,009  

Years Ended June 30, 2018, 2017 and 2016

Net cash used in operating activities was A$16,372,024, A$8,557,524 and A$7,938,557 during the years ended June 30, 2018, 2017 and 2016, respectively. Our payments to suppliers and employees during the years ended June 30, 2018, 2017 and 2016 were A$25,681,347, A$17,676,710 and A$14,894,221, respectively. The increase in payments to suppliers and employees is as the result of investments in commercial, manufacturing, leadership and system capabilities in preparation for the planned U.S. launch of the RECELL System and related

 

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research and development and corporate initiatives. Our operating activity receipts from customers for the years ended June 30, 2018, 2017 and 2016 of A$1,129,046, A$928,687 and A$1,079,549 consisted of commercial sales from Europe and Asia Pacific. Our operating activity receipts from BARDA and other income for the years ended June 30, 2018, 2017 and 2016 of A$8,141,207, A$7,094,061 and A$2,427,188. The BARDA program was received and began in the third quarter of fiscal year 2016 for the expansion of activities surrounding the Company’s PMA submission to the FDA in September 2017 for approval to market the RECELL System in the U.S.

Net cash (used in)/provided by investing activities was A$(498,749), A$195,245 and A$(47,849) during the years ended June 30, 2018, 2017 and 2016, respectively. Cash flows used for investing activities was primarily attributable to payments for the purchase of a property and equipment. During the fiscal year 2017, the Company sold the respiratory business segment and the proceeds from the sale of financial assets was A$627,837.

Net cash provided by financing activities was A$27,934,920, A$8,238,129 and A$9,360,830 for the years ended June 30, 2018, 2017 and 2016. The Company completed a series of equity transactions and received proceeds from issuance of shares and options of A$29,760,563, A$9,048,102 and A$10,025,584 for the years ended June 30, 2018, 2017 and 2016.

We realized a foreign exchange loss of A$29,106, A$257,238 and A$169,100 for the years ended June 30, 2018, 2017 and 2016. The Australian dollar depreciated against the U.S. dollar by 3%, 4% and 3% for the years ended June 30, 2018, 2017 and 2016.

Half-Years Ended December 31, 2018 and 2017

Net cash used in operating activities was A$10,458,479 and A$7,875,025 during the half-years ended December 31, 2018 and 2017, respectively. Our payments to suppliers and employees during the half-years ended December 31, 2018 and 2017 were A$20,305,643 and A$11,943,480, respectively. The increase in payments to suppliers and employees is as the result of investments in commercial, manufacturing, leadership and system capabilities in preparation for the planned U.S. launch of the RECELL System and related research and development and corporate initiatives. Our operating activity receipts from customers for the half-years ended December 31, 2018 and 2017 of A$1,204,802 and A$367,933 consisted of commercial sales from US, Europe and Asia Pacific. Our operating activity receipts from BARDA and other income for the half-years ended December 31, 2018 and 2017 of A$6,104,306 and A$3,676,182. This increase was the result of an expansion of activities related to programs conducted under the BARDA contract during the year. Funding provided by BARDA during the half-year ended December 31, 2018 focused primarily on support of the regulatory activities to support the U.S. approval of the RECELL System, the Continued Access and Compassionate Use programs which provide access to the RECELL System for U.S. patients prior to FDA approval, and two U.S. clinical trials in pediatric burn patients.

Net cash used in investing activities was A$722,472 and A$63,672 during the half-years ended December 31, 2018 and 2017, respectively. Cash flows used for investing activities was primarily attributable to payments for the purchase of property and equipment.

Net cash provided by financing activities was A$25,364,339 and A$15,980,605 for the half-years ended December 31, 2018 and 2017. The Company completed a series of equity transactions and received proceeds from issuance of shares and options of A$28,053,762 and A$17,028,964 for the half-years ended December 31, 2018 and 2017.

We realized a foreign exchange gain/(loss) of A$1,333,440 and A$(55,390) for the half-years ended December 31, 2018 and 2017. The Australian dollar appreciated/(depreciated) against the U.S. dollar by 8% and (3%) for the half-years ended December 31, 2018 and 2017.

 

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Capital management

We aim to manage capital so that the Company continues as a going concern while also maintaining optimal returns to shareholders and benefits for other stakeholders. We also aim to maintain a capital structure that ensures the lowest cost of capital available to the Company. We regularly review the Company’s capital structure and seek to take advantage of available opportunities to improve outcomes for the Company and its shareholders.

For the year ended June 30, 2018, there were no dividends paid and we have no plans to commence the payment of dividends. We have no current plans to issue further shares on the market but will continue to assess market conditions and the company’s cash flow requirements to ensure the Company is appropriately funded.

There is no significant external borrowing at the reporting date. Neither the Company nor any of the subsidiaries are subject to externally imposed capital requirement.

C. Research and Development, Patents and Licenses

In recent years, we have continued our practice of building valuable research collaborations with institutes based primarily in the United States but also in Australia, China and Europe and other regions to enable us to develop a point-of-care solution for the potential treatment of a wide range of skin injuries or defects using a point of care, autologous Spray-On Skin Cells regeneration technology known as RECELL System. These collaborative arrangements ensure that we work with well-respected key option leaders and laboratories without incurring ongoing administrative and personnel costs. All clinical, research and development of RECELL System is performed in compliance with the appropriate governing authorities, regulators and standards. We maintain in-house general counsel and research and development project expertise to coordinate these research collaborations.

Our research and development expenses consist primarily of expenses for contracted research and development activities conducted by major contract research organizations on our behalf, including personnel, testing facilities and other payments in accordance with our research and clinical agreements. Research and development expenses are included in the Product Development Expenses line item of our financial statements, and amounted to $3,266,098, $2,330,297 and $2,160,628 during the years ended June 30, 2018, 2017 and 2016, respectively.

D. Trend Information

While our RECELL System has reached commercialization for specific applications in certain jurisdictions, we seek to further our development and commercialization, and it is not possible for us to predict with any degree of accuracy the outcome of our business in the future.

E. Off-Balance Sheet Arrangements

During fiscal years ended June 30, 2016, 2017 and 2018, we did not have any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

 

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F. Contractual Obligations

The Company’s furniture and IT equipment are held under lease arrangements. As of June 30, 2018, 2017 and 2016 the net carrying amount of the furniture and IT equipment held under lease arrangements are A$159,043, A$66,408 A$ nil, respectively. The Company’s finance lease liabilities, which are secured by the related assets held under finance leases, are classified as follows:

 

     June 30, 2018  

Finance Lease Liabilities

  

Current

   A$ 86,883  

Non-Current

   A$ 72,160  

Total

   A$ 159,043  

 

     Minimum Lease Payment Due  
     Within 1 Year      1-5 Years      After 5 Years      Total  

June 30, 2018

           

Lease Payments

   A$ 114,650      A$ 92,515        —        A$ 207,165  

Finance Charges

     (27,767      (20,355      —          (48,122

Net Present Values

     86,883        72,160        —          159,043  

The Company leases space under operating leases. Future minimum lease payments under such leases as of June 30, 2018 are as follows:

 

     Minimum Lease Payment Due  
     Within 1 Year      1-5 Years      After 5 Years      Total  

June 30, 2018

   A$ 525,919      A$ 856,541        —        A$ 1,382,460  

ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES

A. Directors and Senior Management

The following table sets forth our directors and senior management, their age and the positions they held as of the date of this registration statement on Form 20-F. All of our directors and senior management may be contacted at our registered office located at c/o Mertons Corporate Services Pty Ltd Level 7 330 Collins Street Melbourne VIC 3000, Australia.

 

Name

   Age   

Position

Lou Panaccio(1)    61    Non-Executive Chairman
Dr. Michael Perry    60    Executive Director and Chief Executive Officer
Erin Liberto    45    Chief Commercial Officer
Tim Rooney    52    Chief Administrative Officer and interim Chief Financial Officer
Andrew Quick    48    Chief Technology Officer
Donna Shiroma    56    General Counsel
Jeremy Curnock Cook(2)    69    Non-Executive Director
Louis Drapeau(3)(2)    54    Non-Executive Director
Damien McDonald(1)    53    Non-Executive Director
Professor Suzanne Crowe(4)    68    Non-Executive Director

 

(1)

Member of the Audit Committee

(2)

Member of the Remuneration Committee and the Nomination Committee

(3)

Chairman of the Audit Committee

(4)

Chairman of the Remuneration Committee and the Nomination Committee

Lou Panaccio has served as Non-Executive Chairman of the Board of Directors since July 2014. Mr. Panaccio is a successful healthcare businessman with extensive experience leading companies from concept to

 

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commercialization. Mr. Panaccio possesses more than 30 years of executive leadership experience in healthcare services and life sciences, including more than 20 years of board-level experience. Mr. Panaccio is currently a Non-Executive Director of ASX50 company and one of the world’s largest medical diagnostics companies, Sonic Healthcare Limited, where he has served since 2005. In addition, Mr. Panaccio is Non-Executive Director of Unison Housing Limited, Non-Executive Chairman of Genera Biosystems Limited, a publicly listed company (ASX) that develops and commercializes multiplexed molecular diagnostic tests, and a Non-Executive Director of Rhythm Biosciences Limited, a publicly listed (ASX) development-stage medical diagnostics company.

Dr. Michael Perry was appointed Chief Executive Officer and Executive Director in June 2017. Prior to this appointment, Dr. Perry had served as a Non-Executive Director commencing in February 2013. From 2016 to 2017, he served as Senior Vice President and Chief Scientific Officer of Global Business Development and Licensing for Novartis AG. From 2014 to 2016, Dr. Perry served as Chief Scientific Officer of Novartis’ Cell and Gene Therapy Unit, and from 2012 to 2014 he served as Vice President and Global Head of Stem Cell Therapy for Novartis Pharmaceuticals Corp, a US affiliate of Switzerland-based Novartis AG. Dr. Perry previously served as the Global Head of R&D at Baxter Healthcare, President and CEO of Cell & Gene Therapy at Novartis affiliates Systemix Inc. and Genetic Therapy, Inc., VP Regulatory Affairs at Sandoz Pharmaceuticals Corp., Director of Regulatory Affairs at Schering-Plough Corporation, and Chairman, CEO or CMO at several early stage biotech companies. He also previously served as a Venture Partner with Bay City Capital, LLC, a life science investment firm managing venture capital funds, based in San Francisco California. Dr. Perry serves as a Director of Arrowhead Pharmaceuticals, a public (NASDAQ) development stage company focused on medicines that treat intractable diseases by silencing the genes, and AmpliPhi Biosciences Corporation, Inc., a public (NYSE) clinical-stage biotechnology company focused on the development of bacteriophage-based therapies for the treatment of antibiotic-resistant bacterial infections. He is also a Director at BioScience Managers Pty Ltd, a shareholder of the Company.

Erin Liberto has served as Chief Commercial Officer since August 2017. Ms. Liberto has more than 17 years of multifaceted global commercial experience developing, launching, managing, and optimizing healthcare portfolios with products that span therapeutic and aesthetic indications for international organizations including Allergan and Johnson & Johnson. Ms. Liberto’s proficiency in long-term strategic planning has led to more than a dozen successful product launches across the U.S., Europe, and Asia Pacific. Ms. Liberto holds an International MBA with a concentration in Global Marketing from Thunderbird School of Global Management in Arizona and a Bachelor of Commerce from McMaster University in Canada.

Tim Rooney was appointed Chief Administrative Officer in December 2017 and is responsible for operations of the Company. Mr. Rooney was also appointed as our interim Chief Financial Officer in May 2019. Mr. Rooney has served the Company in multiple roles since joining in October 2012 as Chief Financial Officer and Chief Operating Officer, including interim Chief Executive Officer from 2013 to 2015. Mr. Rooney has over 20 years of experience in senior finance and operations management in medical devices and pharmaceutical wholesale distribution, including PDI Enterprises, Inc., a pharmaceutical wholesale distributor, where he served as Chief Financial Officer and Chief Operating Officer from 1991 to 2007 and served in other roles starting in 1984. Mr., Rooney holds a B.S. degree in Business Administration, Finance from California State University, Northridge.

Andrew Quick was appointed Chief Technology Officer in April 2019 and previous to that served as Senior Vice President, Clinical Development beginning July 2010. Mr. Quick has more than 25 years of experience in medical device design, development, clinical research and medical affairs. Mr. Quick has previously held leadership positions in the development of diagnostic instrumentation and active implantable therapeutics, including most recently with Boston Scientific Neuromodulation / Advanced Bionics from 2006 to 2010 where he led U.S. investigational device and post-market clinical research in the cochlear implant business. He also served in a series of positions with SonaMed Corporation from 1994 to 2005, including Vice President, Products and Clinical Affairs. Mr. Quick has B.S. and M.S. degrees in Biomedical Engineering from Boston University.

Donna Shiroma has served as General Counsel since June 2018. Ms. Shiroma has more than 20 years of legal and compliance experience in the pharmaceutical and medical device industries and has played an instrumental role in

 

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transitioning companies from clinical to commercial entities. Prior to joining the Company, she served in roles of increasing responsibility as corporate counsel, general counsel, vice president of legal, chief privacy and compliance officer, and chief commercial officer for Astrex Pharmaceuticals from 2017 to 2018, Ascend Therapeutics from 2008 to 2017, PDL BioPharma from 2006 to 2008, and several Johnson & Johnson companies. Ms. Shiroma holds a B.S. in Environmental Sciences from University of California Berkley, and a Juris Doctor degree from Santa Clara University School of Law. She is licensed in the State of California as an attorney.

Jeremy Curnock Cook has served as a Non-Executive Director of the Board since October 2012. Mr. Curnock Cook is currently the Managing Director of Bioscience Managers Pty Ltd, a shareholder of the Company, responsible for the BM Asia Pacific Healthcare Fund, and serves as Chairman of International Bioscience Managers Ltd. He is the former head of the life science private equity team at Rothschild Asset Management, and was responsible for the launch of the first dedicated biotechnology fund for the Australian market and the conception and launch of the International Biotechnology Trust. Mr. Curnock Cook serves as a Non-Executive Director of Adherium Ltd, a public (ASX) company with a digital health platform focused on improving medication adherence and patient outcomes, and AmpliPhi Biosciences Corporation, Inc., a public (NYSE) clinical-stage biotechnology company focused on the development of bacteriophage-based therapies for the treatment of antibiotic-resistant bacterial infections. He also serves as an Alternate Director for Sea Dragon Limited, a public (NZX) company processing fish oils into marine bioactive compounds. Mr. Curnock Cook previously served as a Non-Executive Director of Phylogica Limited, a public (ASX) company developing next generation intracellular biological therapeutics.

Louis Drapeau has served as Non-Executive Director of the Board since January 2016. Mr. Drapeau has considerable expertise in both the biotech sector and with the financial reporting and other requirements of U.S. public companies. Mr. Drapeau is an Independent Director at AmpliPhi Biosciences Corporation, Inc., a public (NYSE) clinical-stage biotechnology company focused on the development of bacteriophage-based therapies for the treatment of antibiotic-resistant bacterial infections. Mr. Drapeau has held senior positions with Insite Vision Inc., Nektar Therapeutics and BioMarin Pharmaceutical, Inc., and served as an Audit Partner at Arthur Andersen LLP. Mr. Drapeau was previously an Independent Director at Bio-Rad Laboratories, a public (NYSE) company manufacturing products for the life science research and clinical diagnostics markets, and InterMune, Inc., a public (NASDAQ) commercial-stage biotech company. He has an MBA from Stanford University.

Damien McDonald has served as a Non-Executive Director since January 2016. Mr. McDonald has a proven track record of achieving value in the medical device space. Mr. McDonald is currently Chief Executive Officer and a Director of the Board of LivaNova plc, having previously served as Chief Operating Officer. LivaNova plc is a public (NASDAQ) company that is a leader in cardiovascular and neuromodulation solutions. Prior to that, he was a Group Executive and Corporate Vice President at NYSE-listed Danaher Corporation, a multinational science and technology innovation company that acquires and produces life science and industrial products and brands, where he led a $1.5 billion group of dental consumable companies. Earlier in his tenure, Mr. McDonald was Group President of Kerr where he and his team focused on building a strong research and development pipeline while improving operational performance utilizing the Denaher Business System. He has also previously worked for Merck &Co, Johnson & Johnson and Zimmer. Mr. McDonald has B.S. degrees in both pharmacy and economics from the University of Queensland, a master’s degree in International Economics from the University of Wales, and an MBA from IMD of Lausanne, Switzerland.

Professor Suzanne Crowe AM has served as a Non-Executive Director since January 2016. Australian-based, she is a physician-scientist and company director with extensive expertise in supporting companies with their medical and scientific strategies. Professor Crowe is a Principal Research Fellow of the Australian National Health and Medical Research Council. She is a Principal Specialist in Infectious Diseases at The Alfred Hospital, Melbourne and Adjunct Professor of Medicine and Infectious Diseases at Monash University, Melbourne, and has published more than 200 peer-reviewed papers. Professor Crowe is a member of the Australian Institute of Company Directors and is a Director of St Vincents Health Australia, the country’s largest not-for-profit health and aged care provider. Professor Crowe was appointed as a Member of the Order of Australia (AM) in 2011 to recognize her service to

 

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medical research in HIV/AIDS. She has medical and MD degrees from Monash University, an internal medicine specialist qualification in Infectious Diseases from the Royal Australasian College of Physicians, and a Diploma in Medical Laboratory Technology from the Royal Melbourne Institute of Technology.

B. Compensation

Remuneration Principles

This Remuneration Report outlines the Director and Executive remuneration arrangements of the Company in accordance with the requirements of the Australian Corporations Act 2001 and its Regulations. For the purposes of this report Key Management Personnel (KMP) of the Company are defined as those persons having authority and responsibility for planning, directing and controlling the major activities of the Company, directly or indirectly, including any Director (whether Executive or otherwise) of the parent Company. For the purposes of this report, the term ‘executive’ encompasses the Chief Executive and Senior Executives of the Company.

During the year ended June 30, 2018 we appointed Erin Liberto as our Chief Commercial Officer effective August 28, 2017 and Donna Shiroma as General Counsel effective June 25, 2018. We also appointed Dale Sander as Chief Financial Officer effective December 5, 2017, and he served in that position until his resignation on May 15, 2019. On December 5, 2017 the Company also appointed of Timothy Rooney as Chief Administrative Officer, and effective May 15, 2019 Mr. Rooney was also appointed as our interim Chief Financial Officer.

Effective April 1, 2019 Andrew Quick was promoted from Senior Vice President Clinical Development to Chief Technology Officer. There were no other changes of Key Management Personnel after the reporting date and through the date of this registration statement on Form 20-F.

In prior years we identified a number of key areas for additional emphasis which has resulted in a review of remuneration practices, policies and plans associated with key management personnel remuneration. To develop an appropriate foundation for future practices the Remuneration Committee has a formal Remuneration Governance Framework which, at the core, consists of:

 

   

A revised Remuneration & Nomination Committee Charter which now mandates the development and maintenance of other Remuneration Governance Framework elements;

 

   

A Senior Executive Remuneration Policy;

 

   

A Short-Term Incentive (STI) Policy & Procedure document; and

 

   

A Long-Term Incentive (LTI) Policy & Procedure document.

Remuneration Committee

The Remuneration Committee of the Board of Directors of the Company is responsible for determining and reviewing remuneration arrangements for the Board and Executives.

The Remuneration Committee assesses the appropriateness of the nature and amount of remuneration of Executives on a periodic basis by reference to relevant employment market conditions with the overall objective of ensuring maximum stakeholder benefit from the retention of a high-quality Board and executive team.

Use of Remuneration Consultants

The Company did not make use of any external remuneration consultants during the financial year, although it did obtain from third parties industry benchmarking information.

 

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Remuneration Framework, Philosophy and Policies

The performance of the Company depends upon the quality of its Directors and Executives. To prosper, the Company must attract, motivate and retain highly skilled Directors and Executives. To this end, the Company embodies the following principles in its remuneration framework:

 

   

Provide competitive rewards to attract and retain high caliber Executives;

 

   

Acceptability to shareholders through transparency and engagement, and ensuring that remuneration frameworks and practices are appropriate to the circumstances of the Company as it evolves;

 

   

Performance linkage to and alignment with Executive compensation; and

 

   

Establish appropriate, demanding performance hurdles as a prerequisite to payment of variable Executive remuneration.

The main focus of executives and of performance assessment for Fiscal 2018 was related to the U.S. PMA application for the RECELL System, related activities required to support FDA approval, and preparation for the planned market launch of the RECELL System in the U.S. For the current year, the primary focus is on the successful market launch of the RECELL System in the U.S., advancement of the Company’s pipeline and successful completion of the listing of our ADSs on the NASDAQ Capital Market (US Quotation). Incentives are intended to be linked to shareholder value via milestone completion, clinical trial outcomes and total shareholder return.

Non-Executive Director Remuneration

Objective: The Board seeks to set aggregate remuneration at a level which provides the Company with the ability to attract and retain Directors of the highest caliber, whilst incurring a cost which is acceptable to shareholders.

Policy: The amount of aggregate remuneration sought to be approved by shareholders and the fee structure is to be commercially acceptable, competitive and subject to an annual review. The Board considers industry benchmarking data regarding the fees paid to Non-Executive Directors of comparable companies when undertaking the annual review process.

Structure: In accordance with best practice corporate governance, the structure of Non-Executive Director and Senior Management remuneration is separate and distinct. The Constitution and the ASX Listing Rules specify that the aggregate remuneration of Non-Executive Directors shall be determined from time to time by a general meeting. The latest determination was at the Annual General Meeting held on November 29, 2005 when shareholders approved an aggregate remuneration of $450,000 per year in respect of fees payable to Non-Executive Directors. Please refer to Table 2 of this report for the allocation of Directors’ fees.

Each Director receives a fee for being a Director of the Company and includes attendance and participation at Board and committee meetings. The Non-Executive Directors do not participate in any incentive programs.

The remuneration of Non-Executive Directors for the year ended June 30, 2018 is detailed in Table 2 of this report.

Executive Remuneration (including Executive Directors)

Objective: The Company aims to reward Executives with a level and mix of remuneration commensurate with their position and responsibilities within the Company so as to:

 

   

reward Executives for Company and individual performance against targets set by reference to appropriate benchmarks as well as to specific short- and long-term goals of the Company;

 

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align the interests of Executives with those of shareholders; and

 

   

ensure total remuneration is competitive by market standards.

Policy: The Company’s broad framework for the Remuneration Committee requires the committee to ensure that:

 

   

executive remuneration packages may involve a balance between fixed and incentive pay, reflecting short and/or long-term performance objectives appropriate to the Company’s circumstances and objectives;

 

   

a proportion of executives’ remuneration is structured in a manner designed to link reward to corporate and individual performances; and

 

   

recommendations are made to the Board with respect to the quantum of bonuses to be paid to executives.

To the extent that the Company adopts a different remuneration structure for its Non-Executive Directors, the Committee shall document its reasons for the purpose of disclosure to stakeholders.

Structure: The Remuneration Committee determines the level and make-up of the Chief Executive remuneration. The Committee takes advice from the Chief Executive with input from industry benchmarking data to set and approve all other executive remuneration. To assist in achieving the Company’s objectives, the Remuneration Committee links the nature and number of officers’ emoluments to the Company’s performance. Remuneration may consist of the following key elements:

 

   

Fixed Remuneration

 

   

Variable Remuneration

 

   

Short Term Incentive (STI) and/or

 

   

Long Term Incentive (LTI)

The proportion of fixed remuneration and variable remuneration (potential short term and long-term incentives) is established for each Executive by the Remuneration Committee annually. Table 2 details the fixed and variable components for the Executives of the Company.

Fixed Remuneration Objective and Structure: The level of fixed remuneration is set so as to provide a base level of remuneration which is both appropriate to the position and is competitive in the market. During the 2018, 2017 and 2016 financial years there were no benefits paid in kind. Fixed remuneration is reviewed annually by the Remuneration Committee and the process consists of a review of Company-wide and individual performance and relevant comparative remuneration in the market.

Variable Remuneration – Short Term Incentive (STI) Objective and Structure: The objective of variable remuneration is to link the achievement of the Company’s operational targets with the remuneration received by the Executives charged with meeting those targets. The Company’s STI objectives:

 

   

Motivate Senior Executives to achieve the short-term annual objectives linked to Company success and shareholder value creation;

 

   

Create a strong link between performance and reward;

 

   

Share Company success with the Senior Executives that contribute to it; and

 

   

Create a component of the employment cost that is responsive to short to medium term changes in the circumstances of the Company.

 

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Variable remuneration is reviewed annually by the Remuneration Committee and the process consists of a review of Company-wide and individual performance and relevant comparative remuneration in the market.

Variable Remuneration – Long Term Incentive (LTI) Objective and Structure: The objective of the LTI plan is to reward Executives in a manner that aligns remuneration with the creation of shareholder value and to create an element of remuneration that supports the executive team working together to achieve this outcome over the long term. The LTI plan is also a key component of the Company’s retention strategy. The Company has two LTI plans available for use with senior executives and staff. At the 2014 AGM, shareholders approved a Performance Rights Plan. At the General Meeting of shareholders on August 24, 2015, shareholders approved a share loan plan for senior executives. Currently no loans are outstanding under the share loan plan.

LTI for 2018 financial year

In addition to the before mentioned CEO Long Term Incentive Plan (Operating and Financial Review), 9,110,000 share options were granted during FY18. The Company has two separate LTI plans that it can use as part of incentivizing senior executives and staff for achieving targeted Key Performance Indicators (KPIs) including financial and non-financial targets, corporate metrics and individual measures of performance.

Remuneration of Key Management Personnel

Table 1: Employment Contracts

The following table outlines the specified terms of the relevant employment contracts for the Key Management Personnel of the Company:

 

Role

 

Name

 

Contract
duration

 

Period of notice

 

Termination payments
provided for by contract

CEO and Executive Director   Dr. Michael Perry   Open ended contract   12-month notice period   12 months
CFO   Dale Sander(1)   Open ended contract   6-month notice period   6 months
CAO   Timothy Rooney(2)   Open ended contract   12-month notice period   12 months
CCO   Erin Liberto   Open ended contract   6-month notice period   6 months
SVP, Clinical Development   Andrew Quick(3)   Open ended contract   3-month notice period   Payment in lieu of notice only, no other benefits specified
Non-Executive Chairman   Lou Panaccio   Open ended contract   No notice period-subject to Avita constitution   Payment in lieu of notice only, no other benefits specified
All other Non-Executive Directors   Jeremy Curnock Cook   Open ended contract   No notice period-subject to Avita constitution   Payment in lieu of notice only, no other benefits specified
  Louis Drapeau   Open ended contract   No notice period-subject to Avita constitution   Payment in lieu of notice only, no other benefits specified
  Damien McDonald   Open ended contract   No notice period-subject to Avita constitution   Payment in lieu of notice only, no other benefits specified
  Professor Suzanne Crowe   Open ended contract   No notice period-subject to Avita constitution   Payment in lieu of notice only, no other benefits specified

 

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(1)

Mr. Sander resigned as Chief Financial Officer effective May 15, 2019.

(2)

Mr. Rooney was appointed interim Chief Financial Officer effective May 15, 2019.

(3)

Mr. Quick was promoted to Chief Technology Officer effective April 1, 2019.

Table 2: Remuneration for the year ended June 30, 2019

 

    Short-term Benefits           Post-
employment
Benefits
    Equity-settled
Share-based
Payments
    Total     Proportion of
Element of
Remuneration
Related to
Performance
(Other than
Options
Issued)(1)
    Proportion of
Elements of
Remuneration
Not Related to
Performance(2)
 
    Salary,
fees and
leave
A$
    Profit
share and
bonuses
A$
    Non-
monetary
benefits
A$
    Other
benefits
A$
    Pension and
superannuation
A$
    Shares/
Units
A$
    Options/
Rights
A$
    A$     Non-salary
Cash-based
Incentives
%
    Shares/
Units
%
    %  

Non-Executive Directors

                     

Lou Panaccio
Non-Executive Chairman

    58,758       —         —         —         7,481       19,992       —         86,231       0     0     91

Jeremy Curnock Cook

    61,040       —         —         —         —         —         —         61,040       0     0     100

Louis Drapeau

    60,811       —         —         —         —         —         —         60,811       0     0     100

Damien McDonald

    —         —         —         —         —         61,128       —         61,128       0     0     100

Suzanne Crowe

    45,989       —         —         —         5,296       9,755       —         61,040       0     0     91
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

       

Sub-total

    226,598       —         —         —         12,777       90,875       —         330,250        
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

       

Other Key Management Personnel & Executives

                     

Michael Perry
CEO(3)

    663,926       515,159       27,608       —         43,148       536,679       401,752       2,188,272       24     25     34

Timothy Rooney
CAO and Interim CFO

    441,683       147,893       16,550       —         23,106       —         136,647       765,879       19     0     63

Dale Sander
CFO(4)

    379,908       246,299       31,660       270,450       23,193       —         80,727       1,032,237       24     0     68

Erin Liberto
CCO

    398,353       147,893       41,897       —         22,530       —         207,097       817,770       18     0     57

Andrew Quick
CTO

    403,853       119,723       36,807       —         23,592       —         181,914       765,889       16     0     61

Donna Shiroma
GC

    419,319       117,519       13,632       —         27,075       —         302,915       880,460       13     0     52
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

       

Sub-total

    2,707,042       1,294,486       168,154       270,450       162,644       536,679       1,311,052       6,450,507        
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

       

Totals

    2,933,640       1,294,486       168,154       270,450       175,421       627,554       1,311,052       6,780,757        
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

       

 

(1)

Non-salary cash-based incentives % is equal to profit share and bonuses divided by total compensation. Shares or units % is equal to shares or units divided by total compensation.

 

(2)

The percentage disclosed does not include the value of options expensed during the year or pension and superannuation benefits paid per the requirements of corporations act (Australia) 2001. Thus, the sum of the percentages for compensation related to performance and compensation not related to performance disclosed for certain individuals may be less than 100%. Proportion of elements of remuneration not related to performance is equal to the sum of salary, fees and leave, non-monetary benefits, pension and superannuation and other compensation, divided by total compensation. As an example, for Dr. Michael Perry, this calculation would be as follows: (A$663,926+A$27,608+A$43,148) / A$2,188,272 = 34%

 

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(3)

On November 30, 2017, 50,000,000 Restrictive Stock Units, issued as part of a long term incentive, or “LTI,” each equal to one ordinary share, were issued to Dr. Michael Perry based on the following milestones:

 

  a.

Tenure – a total of 16,666,666 LTIs issued but to vest over the three-year period commencing July 1, 2017;

 

  b.

Company Share Price – a total of 16,666,666 LTIs issued but to vest in three equal tranches subject to the Volume Weighted Average Price (VWAP) of Company share price (as at close of trade on the ASX on relevant date) achieving multiples of 2x, 3x and 4x the Company’s share price at the time of shareholder approval; and

 

  c.

Milestone performance – a total of 16,666,668 LTIs issued, but to vest in two equal tranches with one tranche to vest upon the achievement of the following milestones: (1) FDA PMA approval of RECELL for burns, and (2) Initial BARDA procurement under CLIN2 of the BARDA Contract

 

(4)

Mr. Sander resigned and Chief Financial Officer effective May 15, 2019.

Table 3: Compensation of Key Management Personnel

 

     2019
A$
     2018
A$
     2017
A$
 

Short-term employee benefits

     4,396,280        3,770,141        2,933,510  

Post-employment employee benefits

     445,871        90,512        112,034  

Share-based payment

     1,938,606        1,596,368        1,215,809  
  

 

 

    

 

 

    

 

 

 

Total compensation

     6,780,757        5,457,021        4,261,353  
  

 

 

    

 

 

    

 

 

 

Table 4: Option Holdings of Key Management Personnel

The fair value of options granted as remuneration and as shown in the above table has been determined in accordance with Australian Accounting Standards and will be recognized as an expense over the relevant vesting period to the extent that conditions necessary for vesting are satisfied. Options issued to key management personnel have vesting criteria corresponding to the following conditions:

 

   

Tenure with the Company

 

   

Revenue target

 

   

FDA PMA approval of RECELL for burns

 

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Initial BARDA procurement under CLIN2 of the BARDA Contract

 

   

US Quotation

 

    Balance at     Grant Details     Exercised     Balance at     Vested     Unvested     Unvested  
    July 1,
2018

No.
    Issued
Date
  No.     Value
A$
    No.     Value
A$
    June 30,
2019
    Exercisable     Unexercisable     Total at
June 30,
2019
    Balance at
June 30,
2019
    Total at
June 30,
2019
 

Michael Perry

    —       November 30,
2018
    15,000,000       812,500       —         —         15,000,000       10,833,333       —         10,833,333       4,166,667       4,166,667  

Timothy Rooney

    7,800,000     —       —         —         1,750,000       131,950       6,050,000       4,330,000       —         4,330,000       1,720,000    
    November 1,
2018
    500,000       32,839       —         —         500,000       —         —         —         500,000    
    November 30,
2018
    3,420,000       196,822       —         —         3,420,000       —         —         —         3,420,000    
    November, 30
2018
    360,000       84,816       —         —         360,000       —         —         —         360,000       6,000,000  

Andrew Quick

    4,518,750     —       —         —         —         —         4,518,750       3,211,250       —         3,211,250       1,307,500    
    November 1,
2018
    500,000       32,839       —         —         500,000       —         —         —         500,000    
    November 30,
2018
    3,021,250       173,873       —         —         3,021,250       —         —         —         3,021,250    
    April 1, 2019     4,040,000       759,722       —         —         4,040,000       —         —         —         4,040,000       8,868,750  

Troy Barring

    1,110,000     —       —         —         1,110,000       34,474       —         —         —         —         —         —    

Erin Liberto

    4,000,000     —       —         —         —         —         4,000,000       2,300,000       —         2,300,000       1,700,000    
    November 1,
2018
    2,110,000       138,574       —         —         2,110,000       —         —         —         2,110,000    
    November 30,
2018
    5,970,000       343,574       —         —         5,970,000       —         —         —         5,970,000       9,780,000  

Dale Sander(1)

    4,000,000     —       —         —         4,000,000       199,200       —         —         —         —         —         —    

Donna Shiroma

    3,000,000     —       —         —         —         —         3,000,000       1,520,000       —         1,520,000       1,480,000    
    November 1,
2018
    2,610,000       171,412       —         —         2,610,000       —         —         —         2,610,000    
    November 30,
2018
    6,470,000       372,349       —         —         6,470,000       —         —         —         6,470,000       10,560,000  
 

 

 

     

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 
    24,428,750         44,001,250       3,119,320       6,860,000       365,624       61,570,000       22,194,583       —         22,194,583       39,375,417       39,375,417  
 

 

 

     

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Mr. Sander resigned as Chief Financial Officer effective May 15, 2019.

Other Equity-related Transactions with Key Management Personnel

Other than set forth below, there have been no other transactions involving equity instruments apart from those described in the tables above, relating to options and shareholdings:

On November 30, 2018, the shareholders of the Company approved and Dr. Perry was issued 15,000,000 options to purchase ordinary shares at an exercise price of A$0.0820. The vesting of such options is based on (i) tenure of Dr. Perry, (ii) the Company’s Share Price and (iii) milestone performance by the Company as follows:

 

  (a)

Tenure – a total of 7,499,999 options issued for immediate vesting and over the two-year period commencing July 1, 2017;

 

  (b)

Company Share Price – a total of 5,000,001 options issued but to vest in three equal tranches subject to the Volume Weighted Average Price (VWAP) of Company share price (as at close of trade on the ASX on relevant date) achieving multiples of 2x, 3x and 4x the Company’s share price at the time of shareholder approval; and

 

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  (c)

Milestone performance – a total of 2,500,000 options issued, but to vest upon the achievement of initial BARDA procurement under CLIN2 of the BARDA Contract.

Other Transactions with Key Management Personnel and/or their Related Parties

There were no other transactions conducted between the Company and KMP or their parties, apart from those disclosed above relating to equity and compensation, that were conducted other than in accordance with normal employees, customer or supplier relationships on terms no more favorable than those reasonably expected under arm’s length dealings with unrelated persons.

C. Board Practices

Introduction

Our Board of Directors is elected by and accountable to our shareholders. It currently consists of six directors, the executive Chairman, four non-executive directors and our Chief Executive Officer who also serves as an Executive Director. The Chairman of our Board of Directors is responsible for the management of the Board of Directors and its functions.

Election of Directors

Directors are elected at our annual general meeting of shareholders. Under our Constitution, a director, other than a managing director, must not hold office for more than three years or beyond the third annual general meeting following his or her appointment (whichever is the longer period) without submitting himself for re-election. Our Board of Directors has the power to appoint any person to be a director, either to fill a vacancy or as an additional director (provided that the total number of directors does not exceed the maximum allowed by law), and any director so appointed may hold office only until the next annual general meeting when he or she shall be eligible for election.

Corporate Governance

ASX Corporate Governance Principles

In Australia there are no mandatory corporate governance structures and practices that must be observed by a company listed on the ASX. Instead, the ASX Corporate Governance Council has published the ASX Best Practice Guide, which contains what are called the “Recommendations,” which articulate eight core principles (and associated recommendations) which are intended to provide a reference point for companies about their corporate governance structures and practices, and against which companies must report.

Under ASX listing Rule 4.10.3, companies are required to provide a statement in their annual report to shareholders disclosing the extent to which they have followed the Recommendations in the reporting period. Where a company has not followed all the Recommendations, it must identify the Recommendations that have not been followed, the reasons for not following them, and what (if any) alternative governance practices it adopted in lieu of the recommendation during that period. It is not mandatory to follow the Recommendations. We believe we are in material compliance with the ASX Corporate Governance Principles.

Set forth below are the material provisions of the ASX Corporate Governance Principles together with the reasons, where applicable, for variations therefrom:

 

  1.

Lay solid foundations for management and oversight. Companies should clearly delineate the respective roles and responsibilities of board and management and regularly review their performance.

 

  2.

Structure the Board to be effective and add value. Listed companies should have a board of an appropriate size and collectively have the skills, commitment and knowledge of the entity and the

 

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  industry in which it operates, to enable it to discharge its duties effectively and to add value. During the year ended June 30, 2018, we did not follow this Recommendations in the following area:

 

  a.

No formal performance evaluation of the Board was conducted for the year ended June 30, 2018 as the Board believes that the Company is not of a size, nor is its our financial affairs of such complexity, to warrant such an exercise. The Board recognizes the importance of performance evaluations and will continually assess the necessity and timing of future performance evaluation.

 

  3.

Instill a culture of acting lawfully, ethically and responsibly. A listed entity should instill and continually reinforce a culture across the organization of acting lawfully, ethically and responsibly.

 

  4.

Safeguard the integrity of corporate reports. A listed entity should have appropriate processes to verify the integrity of its corporate reports

 

  5.

Make timely and balanced disclosure. A listed entity should promote timely and balanced disclosure of all material matters concerning it that a reasonable person would expect to have a material effect on the price or value of its securities. During the year ended June 30, 2018, we did not follow this Recommendations as we only adopted written policies designed to promote timely and balanced disclosure in accordance with ASX Listing Rule disclosure requirements for the year ending June 30, 2019. Our executive officers and members of our Board of Directors are aware of the obligations for continuous disclosure under the ASX Listing Rules and meet on a regular basis to ensure compliance.

 

  6.

Respect the rights of security holders. A listed entity should provide its security holders with appropriate information and facilities to allow them to exercise their rights as security holders effectively.

 

  7.

Recognize and manage risk. A listed entity should establish a sound system of risk management and periodically review the effectiveness of that framework.

 

  8.

Remunerate fairly and responsibly. A listed entity should pay director remuneration sufficient to attract and retain high quality directors and design its executive remuneration to attract, retain and motivate high quality senior executives and to align their interests with the creation of value for security holders and with the entity’s values and risk appetite.

Non-Executive and Independent Directors

Australian law does not require a company to appoint a certain number of independent directors to its board of directors or audit committee. However, under the ASX Corporate Governance Principles and Recommendations, the ASX recommends, but does not require, that a ASX-listed company have a majority of independent directors on its board of directors and that the audit committee be comprised of independent directors, within the meaning of the rules of the ASX.

Our Board of Directors currently have five directors, of which we view four are independent non-executive directors within the meaning of the ASX Corporate Governance Principles and Recommendations, and our audit committee consists of three independent non-executive directors. Accordingly, we currently comply with the Recommendations.

Under NASDAQ Marketplace Rules, in general a majority of our Board of Directors must qualify as independent directors within the meaning of the NASDAQ Marketplace Rules and our audit committee must have at least three members and be comprised only of independent directors, each of whom satisfies the respective “independence” requirements of NASDAQ and the U.S. Securities and Exchange Commission.

The Board of Directors does not have regularly scheduled meetings at which only independent directors are present. The Board of Directors does meet regularly, and independent directors are expected to attend all such meetings. Our practices are consistent with the Recommendations, in that the Recommendations do not provide that independent directors should meet separately from the Board of Directors.

 

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Our Board of Directors has determined that each of Lou Panaccio, Jeremy Curnock Cook, Louis Drapeau, Damien McDonald and Suzanne Crowe qualifies as an independent director under the requirements of the ASX, NASDAQ Marketplace Rules and U.S. Securities and Exchange Commission.

Committees of the Board of Directors

Audit Committee. NASDAQ Marketplace Rules require us to establish an audit committee comprised of at least three members, each of whom is financially literate and satisfies the respective “independence” requirements of the U.S. Securities and Exchange Commission and NASDAQ and one of whom has accounting or related financial management expertise at senior levels within a company.

Our Audit Committee assists our Board of Directors in overseeing the accounting and financial reporting processes of our company and audits of our financial statements, including the integrity of our financial statements, compliance with legal and regulatory requirements, our independent public accountants’ qualifications and independence, and independent public accountants, and such other duties as may be directed by our Board of Directors. The Audit Committee is also required to assess risk management.

Our Audit Committee currently consists of three board members, each of whom satisfies the “independence” requirements of the U.S. Securities and Exchange Commission, NASDAQ Marketplace Rules and ASX Rules. Our Audit Committee is currently composed of Messrs. Drapeau, Panaccio and McDonald. Each qualifies as an “independent director” within the meaning of NASDAQ Marketplace Rules. Mr. Drapeau is the chairman of the audit committee. The audit committee meets at least two times per year.

Remuneration (Compensation) Committee. Our Board of Directors has established a Remuneration Committee, which is comprised by majority of independent directors, within the meaning of NASDAQ Marketplace Rules. The Remuneration Committee is responsible for reviewing the salary, incentives and other benefits of our directors, senior executive officers and employees, and to make recommendations on such matters for approval by our Board of Directors. The Remuneration Committee is also responsible for overseeing and advising our Board of Directors with regard to the adoption of policies that govern our compensation programs. Ms. Crowe and Messrs. Drapeau and Cook are the current members of the Remuneration Committee and each qualifies as an “independent director” within the meaning of NASDAQ Marketplace Rules. Ms. Crowe is the chairman of this committee.

Nomination Committee. Our Board of Directors has established a Nomination Committee. Ms. Crowe and Messrs. Drapeau and Cook are the current members of the Nomination Committee and each qualifies as an “independent director” within the meaning of NASDAQ Marketplace Rules. Ms. Crowe is the chairman of this committee. The Nomination Committee is responsible for identifying individuals qualified to become members of our Board of Directors, recommending to our Board of Directors nominees for election at meetings of our shareholders or to fill vacancies that arise on our Board of Directors, and recommending to our Board of Directors qualified and experienced directors to serve on the committees of our Board of Directors.

Directors’ Service Contracts

For details of directors’ service contracts providing for benefits upon termination of employment, see “Item 6. Directors, Senior Management and Employees – B. Compensation – Service Agreements.”

Indemnification of Directors and Officers

Our Constitution provides that, we may indemnify a person who is, or has been, an officer of our company, to the full extent permissible by law, out of our property against any liability incurred by such person as an officer in defending proceedings, whether civil or criminal, and whatever their outcome.

 

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In addition, our Constitution provides that to the extent permitted by law, we may pay, or agree to pay, a premium in respect of a contract insuring a person who is or has been an officer of our company or one of our subsidiaries against any liability:

 

   

incurred by the person in his or her capacity as an officer of our company or a subsidiary of our company, and

 

   

for costs and expenses incurred by that person in defending proceedings relating to that person acting as an officer of Avita, whether civil or criminal, and whatever their outcome.

We maintain a directors’ and officers’ liability insurance policy. We have established a policy for the indemnification of our directors and officers against certain liabilities incurred as a director or officer, including costs and expenses associated in successfully defending legal proceedings.

D. Employees

As of June 30, 2019, we had 95 full-time employees, of which 80 were located in the U.S., two were located in Europe and one in Australia. Of these full-time employees, 30 are engaged in sales and marketing activities, 14 are engaged in research and development activities, 21 are engaged in manufacturing, quality and regulatory activities and 20 are engaged in corporate administrative activities. None of our employees is represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good.

E. Share Ownership

Beneficial Ownership of Senior Management and Directors

The beneficial ownership of senior management and directors are set out in Item 7 (A).

F. Stock Option Plan

In November 2014, we adopted the Employee Share Plan and the Incentive Option Plan (collectively, the 2016 Plans). The Employee Share Plan was amended at the 2018 AGM. Under the 2016 Plans, we may issue stock options or other share-based instruments representing up to 7.5% of our ordinary shares outstanding, or a total of 139,832,968 ordinary shares based on the number of ordinary shares currently outstanding. Any increase in the maximum number of ordinary shares issuable under the 2016 Plans is subject to shareholder approval or to an increase in the total number of ordinary shares outstanding.

The purpose of the 2016 Plans is to promote the success of our Company by incentivizing our employees and directors to contribute to the creation of shareholder value. Under the 2016 Plans, we may issue to employees and directors of our Company and its subsidiaries, from time to time, options to purchase ordinary shares or other share-based instruments. To date, the 2016 Plans have only been used to issue options to purchase ordinary shares to employees.

The 2016 Plans are administered by the Remuneration Committee. Subject to Board approval where required by applicable law, the Remuneration Committee has the authority, in its sole discretion, to grant options under the 2016 Plans, to interpret the provisions of the 2016 Plans, and to prescribe, amend, and rescind rules and regulations relating to the 2016 Plans or any issue or grant thereunder as it may deem necessary or advisable, subject to any other approval if required by applicable law. All decisions made by the Remuneration Committee pursuant to the provisions of the 2016 Plans will be final, conclusive and binding on all persons.

The number of shares issued or options granted, the exercise price and option term or options granted, the vesting schedule and escrow periods of shares issued and options granted, under the 2016 Plans are determined

 

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by the Remuneration Committee, in accordance with the provisions of the 2016 Plans, and specified in an offer document from our Company and accepted by the eligible person, subject to the terms of the 2016 Plans. Options granted under the 2016 Plans will be unlisted and exercisable at an exercise price equal to less than market value of an ordinary share on the ASX at the date of grant, or such other exercise price that the Remuneration Committee determines to be appropriate under the circumstances. The term of an option granted under the 2016 Plans will be determined by the Remuneration Committee; however, no option will be exercisable after the expiration of ten years from the date of its grant. Except as otherwise provided in the 2016 Plans or determined by the Remuneration Committee and set forth in an offer document, the issuance of shares and exercise of options granted under the 2016 Plans will (i) vest over a four year period in four equal installments, 25% at the end of each year from the date of grant, and /or (ii) will be subject to other performance criteria and hurdles, as determined by the Remuneration Committee.

A summary of the status of the 2016 Plans and predecessor plans, as of June 30, 2018, 2017 and 2016, and the changes for the years ended on those dates, is presented below:

 

     As of June 30,  
     2018      2017      2016  
     Amount     Weighted
average
exercise
price
     Amount     Weighted
average
exercise
price
     Amount     Weighted
average
exercise
price
 

Options outstanding at the beginning of the year

   $ 2,281,533     $ 0.09      $ 1,606,936     $ 0.14      $ 1,382,775     $ 0.14  

Granted

     584,800       0.06        1,760,497       0.08        431,661       0.16  

Expired

     (521,036     0.13        (700,900     0.14        (207,500     0.14  

Forfeiture

     (67,067     0.08        (385,000     0.15        —         —    
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Options outstanding at the end of the year

   $ 2,278,230     $ 0.08      $ 2,281,533     $ 0.08      $ 1,606,936     $ 0.15  
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Options exercisable at the end of the year

   $ 914,139     $ 0.09      $ 438,639     $ 0.09      $ 1,606,936     $ 0.15  
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

 

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ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A. Major Shareholders

The following table sets forth information regarding shares of our common stock beneficially owned as of April 30, 2019 by: (i) each of our executive officers and directors; (ii) all the executive officers and directors as a group; and (iii) each person known by us to beneficially own five percent or more of the outstanding ordinary shares.

 

Name of Beneficial Owner

   Ordinary
Shares
     Options to
Purchase
Ordinary
Shares
Exercisable
Within 60
Days
     Restricted
Security
Units (RSUs)
Vested or
Vesting
Within 60
Days
     Total Share
and Share-
Based
Holdings(1)
     %
Ownership(2)
 

5% or more shareholders

              

Redmile Group, LLC(1)

     250,000,000        —          —          250,000,000        13.4

Karst Peak Capital Limited(2)

     196,154,563        —          —          196,154,563        10.5

Blackcrane Capital, LLC(3)

     124,345,592        —          —          124,345,592        6.7

Phillip Asset Management Ltd. atf BioScience Managers Translation Fund(4)

     95,833,334        —          —          95,833,334        5.14

Names executive officers and directors

              

Lou Panaccio

     1,648,564        —          —          1,648,564        *  

Dr. Michael Perry(4)

     61,654        10,833,333        36,111,109        47,006,906        2.5

Erin Liberto

     —          2,050,000        —          2,050,000        *  

Timothy Rooney

     —          5,220,000        —          5,220,000        *  

Andrew Quick

     —          3,307,500        —          3,307,500        *  

Donna Shiroma

     —          —          —          —          *  

Jeremy Curnock Cook(4)

     —          —          —          —          *  

Louis Drapeau

     33,938        —          —          33,938        *  

Damien McDonald

     578,402        —          —          578,402        *  

Professor Suzanne Crowe

     106,910        —          —          106,910        *  

All executive officers and directors as a group (10 persons)

     2,429,468        23,174,583        36,111,109        61,715,160        3.3

 

*

Represents beneficial ownership of less than 1% of the outstanding ordinary shares.

(1)

Consists of 122,918,007 ordinary shares held by Redmile Offshore II Master Fund Ltd. and 127,081,993 ordinary shares held by Redmile Strategic Master Fund LP. Redmile Group, LLC is the investment manager/adviser of Redmile Offshore II Master Fund Ltd. and Redmile Strategic Master Fund LP. Based solely on disclosures provided by Redmile Group, LLC to the ASX, these ordinary shares are owned by certain investment limited partnerships, pooled investment vehicle(s), separately managed accounts, etc. for which Redmile Group, LLC serves as the general partner and/or investment manager. Jeremy Green, as the majority managing member and owner of Redmile Group, LLC, may be deemed to beneficially own securities owned by such investment limited partnerships, pooled investment vehicle(s), separately managed accounts, etc. The principal business address of each of Redmile Group, LLC and Mr. Green is One Letterman Drive, Bldg D, Ste D3-300, San Francisco, CA 94129.

(2)

Consists of 117,801,410 ordinary shares held by Karst Peak Asia Master Fund and 37,896,043 ordinary shares held by Vermilion Peak Fund. Karst Peak Capital Limited is the discretionary investment manager to Karst Peak Asia Master Fund and Vermilion Peak Fund. Based solely on disclosures provided by Karst Peak Capital Limited (KCPL) to the ASX, Adam Leitzes is the director of KPCL and may be deemed to have both voting power and disposal power over the shares. The address for KPCL is Kinwick Centre, Suite 1705, 32 Hollywood Road, Central, Hong Kong.

 

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(3)

Consists of 59,445,952 ordinary shares and 3,244,982 ADSs, each ADS representing 20 ordinary shares or 64,899,640 ordinary shares in total underlying the ADSs. Blackcrane Capital, LLC holds 59,276,225 ordinary shares and 3,184,060 ADSs, with 63,681,200 ordinary shares underlying the ADSs. Blackcrane Overseas Alpha Fund, LLC holders 169,727 ordinary shares and 11,099 ADSs, with 221,980 ordinary shares underlying the ADSs. Blackcrane Capital, LLC is the discretionary investment manager of Blackcrane Overseas Alpha Fund, LLC. Daniel Kim holds 49,823 ADSs with 996,460 ordinary shares underlying the ADSs. Mr. Kim has a relevant interest in the securities held by Blackcrane Capital, LLC and Blackcrane Overseas Alpha Fund as he holds voting power of more than 20% in Blackcrane Capital, LLC. The address of Blackcrane Capital, LLC is 500 108th Avenue NE, STE 960, Bellevue, WA 98004.

(4)

Excludes 81,747,669 ordinary shares held in the name of One Funds Management Limited (Asia Pac Health Fund II A/C) which is managed and beneficially owned by BioScience Managers Pty Ltd of which Mr. Curnock Cook is an officer and Dr. Perry is a Director.

As of April 2, 2019, 38.2% of our ordinary shares were held in Australia, 16.4% of our ordinary shares were held in Hong Kong, 42.4% of our ordinary shares were held in the United States including ordinary shares underlying ADSs.

The Company is not aware that it is directly owned or controlled by another corporation, any foreign government or any other natural or legal person(s) severally or jointly. The Company is not aware of any arrangement, the operation of which may result in a change of control of the Company.

B. Related Party Transactions

Other than employment matters and indemnification agreements between our directors and executive officers, related party transactions were limited to director fees, consultancy fees and travel reimbursements paid under normal terms and conditions to Bioscience Managers Pty Ltd of which Jeremy Curnock Cook is an officer and Dr. Michael Perry is a director. Consultancy services provided were assistance in product development, customer relations, recruitment and sales by Dr. Perry prior to becoming an officer of the Company in June 2017, as well as one other employee of Bioscience Managers Pty Ltd. Total fees paid to Bioscience Managers Pty Ltd were A$157,728, A$128,987 and A$59,675 for the years ended June 30, 2018, 2017 and 2016, respectively.

C. Interests of Experts and Counsel

Not applicable.

ITEM 8. FINANCIAL INFORMATION

A. Consolidated Statements and Other Financial Information

Our audited financial statements for the fiscal years ending June 30, 2018, 2017, and 2016 are included in Item 18 of this registration statement on Form 20-F.

Legal Proceedings

We are not involved in any significant legal, arbitration or governmental proceedings. We are not aware of any pending significant legal, arbitration or governmental proceedings with respect to Avita.

Dividend Distribution Policy

We have never paid cash dividends to our shareholders. We intend to retain future earnings for use in our business and do not anticipate paying cash dividends on our ordinary shares in the foreseeable future. Any future dividend policy will be determined by the Board of Directors and will be based upon various factors, including our results of operations, financial condition, current and anticipated cash needs, future prospects, contractual restrictions and other factors as the Board of Directors may deem relevant.

 

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B. Significant Changes

On September 20, 2018, the U.S. Food and Drug Administration (FDA) approved the Company’s application to market the RECELL System to treat patients with acute thermal burns in the U.S.

Subsequent to June 30, 2018 the Company completed a series of equity transactions in in which the Company received a total of A$45,014,900 in gross proceeds. During the year ended June 30, 2018 the Company completed an institutional placement of shares to international and Australian institutional and sophisticated investors. The institutional placement included a second tranche totaling A$3.250 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the net proceeds of A$3.041 million were received by the Company on July 26, 2018. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the Company issued 65 million shares at a price of A$0.050 per share and received gross proceeds of A$3,250,000 on July 26, 2018. Also subsequent to year end, on December 4, 2018 the Company completed the first tranche of an institutional placement of in which it issued 310,047,015 fully paid ordinary shares at a price of A$0.080 per share raising gross proceeds of A$24,803,761. The institutional placement included a second tranche totaling A$15.196 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on January 14, 2019, and the Company issued 189,952,985 shares at a price of A$0.080 per share and received gross proceeds of A$15,196,239 on January 14, 2019. In addition, on January 11, 2019 the Company complete a Share Purchase Plan under which it issued 22,061,250 shares of stock at a price of A$0.080 per share and received gross proceeds of A$1,764,900.

See also Item 10A under the heading “History of Share Capital” for a listing of recent equity offerings.

 

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ITEM 9. THE OFFER AND LISTING

A. Offer and Listing Details

Australian Securities Exchange

Our ordinary shares have traded on the ASX under the ticker symbol “AVH” since our initial public offering on September 8, 1993. The following table sets forth, for the periods indicated, the high and low market quotations for our ordinary shares as quoted on the ASX:

 

     Per Ordinary Share
(A$)
 
         High              Low      
     A$      A$  

Fiscal Year Ended June 30,

     ASX        ASX  

2014

     .128        .075  

2015

     .106        .054  

2016

     .137        .052  

2017

     .129        .065  

2018

     .080        .046  

Fiscal Year Ended June 30, 2016:

     

First Quarter

     .106        .052  

Second Quarter

     .101        .079  

Third Quarter

     .137        .082  

Fourth Quarter

     .124        .079  

Fiscal Year Ended June 30, 2017:

     

First Quarter

     .129        .079  

Second Quarter

     .121        .094  

Third Quarter

     .112        .077  

Fourth Quarter

     .084        .065  

Fiscal Year Ended June 30, 2018:

     

First Quarter

     .080        .049  

Second Quarter

     .072        .049  

Third Quarter

     .067        .053  

Fourth Quarter

     .083        .048  

Month Ended:

     

July 2018

     .105        .077  

August 2018

     .142        .086  

September 2018

     .140        .089  

October 2018

     .097        .070  

November 2018

     .084        .077  

December 2018

     .135        .079  

January 2019

     .155        .125  

February 2019

     .295        .130  

March 2019

     .540        .285  

April 2019

     .510        .325  

May 2019

     .490        .335  

June 2019

     .440        .340  

July 2019

     .445        .375  

August 2019

     .485        .370  

OTCQX Market

Our ADSs have traded over the counter in the U.S. on the OTCQX under the ticker symbol “AVMXY” since May 14, 2012. We intend to apply with the NASDAQ Capital Market to have our ADSs traded on the

 

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NASDAQ Capital Market. The following table sets forth, for the periods indicated, the high and low market quotations for our ADSs as quoted on the OTCQX:

 

     Per ADS (US$)  
     High      Low  
     US$      US$  

Fiscal Year Ended June 30,

     

2014

     2.74        1.47  

2015

     2.16        0.98  

2016

     2.46        0.93  

2017

     2.24        1.15  

2018

     1.47        0.75  

Fiscal Year Ended June 30, 2016:

     

First Quarter

     1.51        0.93  

Second Quarter

     1.95        1.23  

Third Quarter

     1.89        1.35  

Fourth Quarter

     2.46        1.42  

Fiscal Year Ended June 30, 2017:

     

First Quarter

     1.95        1.35  

Second Quarter

     2.24        1.43  

Third Quarter

     1.86        1.53  

Fourth Quarter

     1.71        1.15  

Fiscal Year Ended June 30, 2018:

     

First Quarter

     1.47        0.79  

Second Quarter

     1.43        0.75  

Third Quarter

     1.25        0.88  

Fourth Quarter

     1.09        0.77  

Month Ended:

     

July 2018

     1.28        0.92  

August 2018

     1.65        1.21  

September 2018

     2.15        1.20  

October 2018

     1.92        1.31  

November 2018

     1.75        1.17  

December 2018

     1.31        1.06  

January 2019

     1.92        1.09  

February 2019

     2.25        1.84  

March 2019

     4.37        1.87  

April 2019

     7.67        4.26  

May 2019

     7.17        4.99  

June 2019

     6.23        4.69  

July 2019

     6.51        5.25  

August 2019

     6.50        4.51  

B. Plan of Distribution

Not applicable.

C. Markets

Our ordinary shares are listed and traded on the Australian Securities Exchange Ltd., or ASX. Although our ADSs are currently quoted on the OTCQX, we intend to be listed on the NASDAQ Capital Market in the first half of 2019. There is no assurance that our NASDAQ listing application will be approved or that an active public market for our ADSs will further develop or be sustained.

 

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D. Selling Shareholders

Not Applicable.

E. Dilution

Not Applicable.

F. Expenses of the Issue.

Not Applicable.

ITEM 10. ADDITIONAL INFORMATION

A. Share Capital

As at the date of this Registration Statement, there is no concept of authorized share capital and par value for companies incorporated in Australia. The Company can issue unlimited number of Ordinary Shares without par value. The Company only has one class of Ordinary Shares.

As at June 30, 2017 and 2018, we had 669,930,538 and 934,312,458 Ordinary Shares issued, outstanding and fully paid, respectively.

Ordinary Shares

Each of our Ordinary Share entitles the holder thereof to one vote at any meeting of Avita’s shareholders. The holder of Ordinary Shares are entitled to receive if, as and when declared by the Board, dividends in such amount as shall be determined by the Board. The holders of Ordinary Shares have the right to receive the Company’s remaining property in the event of a liquidation, dissolution or winding up, whether voluntary or involuntary.

Options

The Company has 111,639,164 share options outstanding at the date of this Registration Statement and 43,193,804 share options available for future grant.

History of Share Capital

For the dates described below, the Company issued Ordinary Shares as follows:

 

Date    Description of Issuance    Number of
Ordinary
Shares Issued
  

Total

(A$)

January 11, 2019    We sold 22,061,250 Ordinary Shares under a Share Purchase Plan at a price of A$0.080 per share, raising gross proceeds of A$1,764,900.    22,061,250    A$1,764,900
December 4, 2018    We sold 500,000,000 Ordinary Shares to institutional investors at a price of A$0.080 per share, raising gross proceeds of A$40,000,000 and incurring A$2,923,858 in expenses.    500,000,000    A$40,000,000
June 6, 2018    We sold 320,475,665 Ordinary Shares to institutional investors at a price of A$0.050 per share, raising gross proceeds of A$16,023,783 and incurring A$1,042,720 in expenses.    320,475,665    A$16,023,783
November 7, 2017    We sold 276,502,853 Ordinary Shares in a rights offering at a price of A$0.045 per share raising gross proceeds of A$12,442,628 and incurring A$636,067 in expenses.    276,502,853    A$12,442,628

 

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Date    Description of Issuance    Number of
Ordinary
Shares Issued
  

Total

(A$)

October 11, 2017    We sold 100,982,978 Ordinary Shares at a price of A$0.045 per share raising gross proceeds of A$4,544,234 and incurring A$248,720 in expenses.    100,982,978    A$4,544,234
July 11, 2016    We sold 100,164,831 Ordinary Shares at a price of A$0.09 per share raising gross proceeds of A$9,048,102 and incurring A A$506,452 in expenses.    100,164,831    A$9,048,102

B. Memorandum and Articles of Association

General

Our constituent document is entitled the Company’s “Constitution”. The Constitution is subject to the Listing Rules of the Australian Securities Exchange (“Listing Rules”) and the Australian Corporations Act 2001 (Cth) (“Corporations Act”). The Company may modify or replace its Constitution, or a provision of the Constitution, by special resolution of shareholders.

Objects and Purposes

As a public company we have all the rights, powers and privileges of a natural person. Our Constitution, which is not required to have an objects or purposes clause, does not provide for or prescribe any specific objects or purposes.

The Powers of the Directors

Under the provisions of our Constitution, our directors may exercise all the powers of our company in relation to:

Management of Company

The business of our Company is managed by the directors who may exercise all the powers of our Company that are not by the Corporations Act. by the Listing Rules or by the Constitution, required to be exercised by the shareholders in general meeting.

Specific powers of Directors

Without limiting the generality of the above paragraph, the directors may exercise all the powers of the Company to borrow or raise money through equity or debt offerings and to issue debentures or give any other security for a debt, liability or obligation of the Company or of any other person.

Other Provisions in the Constitution with Respect to the Directors

Subject to complying with the Corporations Act and the Listing Rules regarding disclosure of and voting on matters involving material personal interests of the directors, their associates and their related or controlled entities, under the provisions of our Constitution, a director may participate in, vote on and be counted in a quorum for any meeting, resolution or decision of the directors and may be present at any meeting where any matter is being considered by the directors.

Under the provisions of our Constitution, the non-executive directors may be remunerated for their services as directors (up to a maximum aggregate amount as determined approved by the Shareholders in general meeting) in individual amounts as determined by the Board. The remuneration of both non-executive and

 

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executive directors must comply with the Corporations Act and the Listing Rules. The Listing Rules provide that a company must not increase the total amount of non-executive directors’ fees payable by it without the approval of its shareholders. The Corporations Act places a limit upon the level of termination benefits that can be paid to a person who holds a managerial or executive office upon that person’s retirement from that office or position.

Subject to the Corporations Act, the Listing Rules and our Constitution, a director must retire from office by no later than the third annual general meeting following his or her appointment or election or 3 years, whichever is longer. If eligible, that retiring director may also seek re-election at the annual general meeting at which that director retires. This requirement for resignation does not apply to the Managing Director.

A candidate for election as a director is not required to hold any ordinary shares to be eligible for election.

Members to Approve Significant Changes to Company Activities

The Listing Rules stipulate that the directors must not make a significant change to the nature or scale of a company’s activities or sell or otherwise dispose of the main undertaking of a listed entity without the prior approval of the Australian Securities Exchange and of the shareholders in general meeting.

Rights, Preferences and Restrictions Attached to Our Ordinary Shares

The concept of authorized share capital no longer exists in Australia and as a result, our “authorized share capital” is unlimited. All our outstanding ordinary shares are validly issued and fully paid. Our ordinary shares have no redemption provisions or sinking fund provisions. The rights attached to our ordinary shares include:

Dividend Rights. Our shareholders have the right to share in our profits distributed as a dividend and any other permitted distribution. Subject to the Corporations Act, our Constitution and the rights of persons entitled to shares with special rights to a dividend (at present there are none), the directors may determine that a dividend is payable, fix the amount and the time for payment and authorize the payment or crediting by the Company to, or at the direction of, each member entitled to that dividend. No dividend is payable except in accordance with the Corporations Act (as amended from time to time) and no dividend carries interest as against the Company.

Voting Rights. At any general meeting of shareholders a resolution put to the vote of the meeting must be decided on a show of hands unless a poll is effectively demanded, and the demand is not withdrawn. On a show of hands, each member present in person and each other person present as a proxy, attorney or representative of a member has one vote. On a poll, each member present in person has one vote for each share held by the member and each person present as proxy, attorney or representative of a member has one vote for each share held by such member that the person represents.

The quorum required for an ordinary meeting of shareholders consists of at least three shareholders present in person, or by proxy, attorney or representative appointed pursuant to our Constitution. A meeting adjourned for lack of a quorum generally is adjourned to the same day in the following week at the same time and place. At the reconvened meeting, the required quorum consists of any two members present in person, or by proxy, attorney or representative appointed pursuant to our Constitution.

An ordinary resolution requires approval by the holders of a majority of the voting rights represented at the meeting, in person, by proxy, or by written ballot and voting thereon. Under the Corporations Act, a special resolution, such as amending our Constitution ,winding-up, or other changes as specified in our Constitution, requires approval of a special majority, representing the holders of no less than 75% of the voting rights represented at the meeting in person, by proxy or by written ballet, entitled to vote and voting thereon.

Rights in the Event of Liquidation. If the Company is wound up, after satisfaction of all liabilities to creditors, the Shareholders are entitled to participate equally pro-rata (per Share owned) in the distribution of the assets of the Company (both capital and surplus), subject only to any amounts unpaid (if any) on their Shares.

 

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Changing Rights Attached to Shares

Our Constitution does not set out a procedure for varying rights attached to our ordinary shares. The Corporations Act provides that if a company has a constitution that does not set out the procedure for varying or cancelling rights attached to shares in a class of shares of a company with share capital, those rights may be varied or cancelled only by a special resolution of the shareholders of the company and a special resolution of the relevant class; or with the written consent of members with at least 75 per cent of the votes in the class.

Annual and Extraordinary General Meetings

Our directors must convene an annual meeting of shareholders at least once every calendar year, within five months of our last fiscal year-end balance date (the fiscal year end date currently being June 30,). Notice of at least 28 calendar days prior to the date of every general meeting is required. The directors or a director may also convene and arrange to hold a general meeting of the Company whenever they think fit. In addition, a general meeting may be convened by one or more shareholders holding in the aggregate at least 5% of the votes that may be cast at the general meeting. A general meeting must be called not more than 21 calendar days after the request is made by the requesting shareholders and must be held not later than two months after the shareholder request is given to the Company.

Limitations on the Rights to Own Securities in Our Company

The Corporations Act takeovers provisions apply to acquisitions of ASX-listed Australian companies. A person cannot acquire a relevant interest (i.e. a controlling interest) in voting securities of an entity that is subject to the takeovers provisions if that would result in any person’s voting power exceeding 20% (or the voting power increasing, if it is already over 20%), except via a specified exception (such as a takeover bid or scheme of arrangement or an incremental increase of up to 3% every 6 calendar months). The most common takeover structures in Australia are an off-market takeover bid and a scheme of arrangement.

Ownership Threshold Above Which Shareholder Ownership Must be Disclosed

Under the Corporations Act, any person who increases their voting power from below to above 5% (or already has voting power of 5% or more and increases or decreases that power by at least 1%) needs to publicly disclose that fact within two business days of that change occurring via the filing of a substantial holding notice with the ASX and upon the Company.

Changes in Our Capital

Subject to the Listing Rules and the Corporations Act, the powers of the Company to issue and cancel shares in the Company and grant options over unissued shares in the Company are vested in the directors. Listing Rule 7.1 provides that (subject to certain exceptions) prior approval of shareholders is required for an issue of securities if the issue of those securities will, when aggregated with all the securities issued by the Company during the previous 12 months without prior shareholder approval, exceed 15% of the number of shares on issue at the commencement of that 12 month period. In addition, Listing Rule 7.1A permits eligible entities that have obtained shareholder approval (by special resolution at its most recent annual general meeting) to issue an additional 10% of the entity’s issued ordinary securities. The ability to issue securities under listing rule 7.1A is in addition to the Company’s ability to issue 15% of its fully paid ordinary shares under Listing Rule 7.1

 

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C. Material Contracts

Except for contracts entered into in the ordinary course of business, the only contracts entered into by Avita within two years immediately preceding this Registration Statement that are still in effect, which may be regarded as material are as follows:

BARDA Contract

We have a contract with Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, valued at least US$50.4 million (approximately A$68.14 million). The contract provides funding for the development of the RECELL System and future use of the product to assist disaster preparedness and response in the U.S. for mass casualties involving burn injuries. We entered into the contract on September 29, 2015, and the scope was expanded as a result of amendments entered into as of June 24, 2016 and September 18, 2017. The contract terminates September 28, 2022 and may be terminated earlier at the option of BARDA.

Under the contract, we have agreed to undertake, and BARDA have agreed to fund and provide technical support for, the development of the RECELL System including two randomized, controlled pivotal clinical trials, Compassionate Use and Continued Access programs, development of the health economic model demonstrating the cost savings associated with the RECELL System, and two randomized, controlled clinical trials in pediatric burn patients. Also included in the BARDA contract is provision for the future procurement of the RECELL System by BARDA under a vendor-managed inventory system to bolster disaster preparedness in the amount of US$7.6 million (approximately A$10.3 million), although BARDA has the option of increasing the amount of the procurement. As of December 31, 2018, we had received cumulative payments of A$22.6 million under the BARDA contract.

D. Exchange Controls and Australian Tax Matters

Exchange Controls

Australia has largely abolished exchange controls on investment transactions. The Australian dollar is freely convertible into U.S. dollars. In addition, there are currently no specific rules or limitations regarding the export from Australia of profits, dividends, capital or similar funds belonging to foreign investors, except that certain payments to nonresidents must be reported to the Australian Transaction Reports and Analysis Centre, which monitors such transaction, and amounts on account of potential Australian tax liabilities which may be required to be withheld unless a relevant taxation treaty can be shown to apply. Article 11.8 of the free trade agreement between Australia and the US provides that all transfers relating to a covered investment is to be made freely and without delay into and out of each territory. Such transfers include inter alia contributions to capital, including the initial contribution; profits, dividends (subject to any applicable withholding tax deduction), capital gains and proceeds from the sale of all or any part of the covered investment or from the partial or complete liquidation of the covered investment.

The Foreign Acquisitions and Takeovers Act 1975

Under Australian law, in certain circumstances foreign persons are prohibited from acquiring more than a limited percentage of the shares in an Australian company without approval from the Australian Treasurer. These limitations are set forth in the Australian Foreign Acquisitions and Takeovers Act, or the Takeovers Act.

Under the Takeovers Act, as currently in effect, any foreign person, together with associates, or parties acting in concert, is prohibited (without approval) from acquiring 20% or more of the shares (or voting / disposal rights attaching to shares) in any ASX listed company. “Associates” is a broadly defined term under the Takeovers Act and includes:

 

   

spouses, lineal ancestors and descendants, and siblings;

 

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any person with whom the person is acting, or proposes to act, in concert;

 

   

partners, officers of companies, the company, employers and employees, and corporations;

 

   

their shareholders related through substantial shareholdings or voting power;

 

   

corporations whose directors are controlled by the person, or who control a person; and

 

   

associations between trustees and substantial beneficiaries of trust estates.

In addition, a foreign person may not acquire shares in a company having total assets of A$266 million or more (or A$1,154 million or more in case of non sensitive companies where it is a private (non-government) U.S. investor(s)) if, as a result of that acquisition, the total holdings of all foreign persons and their associates will exceed 40% in aggregate without the approval of the Australian Treasurer.

If the necessary approvals are not obtained, the Treasurer may make an order requiring the acquirer to dispose of the shares it has acquired within a specified period of time. At present, we do not have total assets of A$266 million or more. At this time, our total assets do not exceed any of the above thresholds and therefore no approval would be required from the Australian Treasurer. Nonetheless, should our total assets exceed the threshold in the future, we will be mindful to monitor the holdings for foreign persons (together with the associates) to ensure that the thresholds will not be exceeded without the Australian Treasurer’s approval.

Each foreign person seeking to acquire holdings in excess of the above caps (including their associates, as the case may be) would need to complete an application form setting out the proposal and relevant particulars of the acquisition/shareholding. The Australian Treasurer then has 30 days to consider the application and make a decision. However, the Australian Treasurer may extend the period by up to a further 90 days by publishing an interim order. The Australian Treasurer has issued a guideline titled Australia’s Foreign Investment Policy which provides an outline of the policy. As for the risk associated with seeking approval, the policy provides that the Treasurer will reject an application if it is contrary to the national interest.

If the level of foreign ownership exceeds 40% at any time (or if one individual not ordinarily resident in Australia, a foreign corporation or a foreign government holds at least 20%), we would be considered a foreign person under the Takeovers Act. In such event, we would be required to obtain the approval of the Australian Treasurer for our company, together with our associates, to acquire (i) more than 20% of an Australian company or business with assets totaling over A$266 million (or A$1,154 million if we were considered a private US investor); or (ii) any direct or indirect ownership in certain real estate interests.

The percentage of foreign ownership in our company would also be included in determining the foreign ownership of any Australian company or business in which we may choose to invest. Since we have no current plans for any such investments or acquisitions and do not currently own any relevant real estate interests, any such approvals required to be obtained by us as a foreign person under the Takeovers Act will not affect our current or future ownership or lease of real estate interests in Australia.

Our Constitution does not contain any additional limitations on a nonresident’s right to hold or vote our securities. Australian law requires the transfer of shares in our company to be made in writing. No stamp duty will be payable in Australia on the transfer of ordinary shares quoted on the NASDAQ.

The Financial Transactions Reports Act 1988

The Financial Transactions Reports Act 1988 is an act of the Parliament of the Commonwealth of Australia, designed to facilitate the administration and enforcement of Australia’s taxation laws. It provides for the reporting of certain financial transactions and transfers, including the export or import of currency exceeding $10,000 to Australian Transaction Reports and Analysis Centre.

 

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The Income Tax Assessment Act of 1936 and the Income Tax Assessment Act of 1997 (collectively, the “Tax Act”)

The Income Tax Assessment Act 1936 and the Income Tax Assessment Act 1997 (collectively, the “Tax Act”) is the principal law governing the imposition of Federal taxes in Australia (except goods and services tax and a number of specific taxes such as fringe benefits tax and stamp duties).

Under the Tax Act, in some circumstances overseas residents are obliged to pay income tax in Australia on income derived from Australian sources or property.

Taxation of Dividends for Non-Australian Resident Shareholders

Non-Australian residents may be liable to pay Australian tax on income derived from Australian sources. One mechanism by which that tax is paid (for nonresidents who have no permanent establishment or fixed base in Australia or where the income is not connected with a permanent establishment or fixed base) is known as withholding tax. Dividends paid by a resident Australian company to a resident of the United States of America who; (a) is entitled to the benefits of the Australia/US Double Tax Agreement (“DTA”); and (b) is beneficially entitled to the dividends; and (c) holds less than 10% of the voting power in the relevant Australian company, are subject to withholding tax at the rate of 15% to the extent the dividends are ‘unfranked’.

The rate of withholding tax is 5% if, the shareholder, is resident of the United State and is a company that holds at least 10% of the voting power in the company paying the dividend.

The rate of withholding tax on dividends is normally 30%, but in accordance with the DTA, the rate may be reduced in the circumstances outlined above.

Under Section 128B(3) of the Income Tax Assessment Act 1936, to the extent that dividends paid to nonresidents have been franked, such dividends are exempt from withholding tax. “Franked dividends” is the expression given to dividends when the profits out of which those dividends are paid have been taxed at company level and such tax is allocated or imputed to the dividend. Accordingly, an Australian company paying fully franked dividends to a nonresident is not required to deduct any withholding tax. Dividends on which withholding tax has been paid are generally not subject to any further Australian tax. In other words, the withholding tax should represent the final Australian tax liability in relation to those dividends. Where the dividend is paid out of foreign sourced income (such as foreign branch income and capital gains) that is declared to be conduit foreign income, no withholding tax is payable. Distributions of conduit foreign income are treated as non assessable nonexempt income of the foreign resident.

Dividends paid to Australian resident shareholders are subject to a different taxation regime.

We have not paid any cash dividends since our inception and we do not anticipate the payment of cash dividends in the foreseeable future. See Item 8.A. “Financial Statements and Other Financial Information–Dividend Distribution Policy.”

Capital Gains Tax

Capital gains tax in Australia is payable on net assessable ‘real gains’ over the period in which the shares have been held, that is, the difference between the selling price and the total cost price calculated under Australian tax law. Nonresident shareholders will not be subject to Australian capital gains tax on any gain made on a sale or other disposal of ordinary shares in an Australian resident company, unless the nonresident shareholders, together with their associates, hold 10% or more of the total paid up share capital at (a) the time of disposal, or (b) any 12 month period in the 2 years prior to disposal.

 

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Nonresident shareholders who own 10% or more of the paid up share capital will be subject to Australian capital gains tax if more than 50% of the assets held by the company directly or indirectly (based on market value), consists of real property situated in Australia (including land and lease holder interests) or Australian mining, quarrying or prospecting rights.

In some cases, if the shares have been held for more than 12 months, certain Australian resident taxpayers who have made a capital gain may be eligible for a discount of up to 50% of the gross gain. Capital losses may be available to offset capital gains. The capital gains discount is not available to non resident individuals on gains accrued after 8 May 2012.

Stamp Duty

Any transfer of shares or ADS through trading on the ASX and NASDAQ, whether by Australian residents or foreign residents, should not be subject to stamp duty on the assumption that the company does not have substantial real property holdings.

Australian Death Duty

Australia does not have estate or death duties. Generally, no capital gains tax liability is realized upon the inheritance of a deceased person’s shares. The disposal of inherited shares by beneficiaries, may, however, give rise to a capital gains tax liability.

Goods and Services Tax

The issue or transfer of shares will not incur Australian goods and services tax and does not require a stockholder to register for Australian goods and services tax purposes.

E. U.S. Federal Income Tax Considerations

The following discussion summarizes certain U.S. federal income tax consequences to a U.S. Holder, as defined below, who purchases our ADSs and ordinary shares. This discussion assumes that investors will hold their ADSs or ordinary shares as capital assets (generally, property held for investment). This discussion does not discuss all aspects of U.S. federal income taxation which may be important to particular investors in light of their individual circumstances, including investors subject to special taxation, such as:

 

   

banks and financial institutions;

 

   

brokers and dealers in securities or currencies;

 

   

insurance companies;

 

   

tax-exempt organizations and retirement plans;

 

   

grantor trusts;

 

   

S corporations;

 

   

persons holding ADSs or ordinary shares as part of hedging, conversion, constructive sale, straddle or other integrated transactions;

 

   

persons who acquired their ordinary shares upon the exercise of employee stock options or otherwise as compensation;

 

   

persons who have elected the mark-to-market method of accounting;

 

   

persons who own 10% or more of our ADSs or shares;

 

   

real estate investment trusts or regulated investment companies;

 

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U.S. persons whose “functional currency” is not the U.S. dollar;

 

   

certain former citizens or long-term residents of the United States; and

 

   

Non-U.S. Holders (as defined below).

This discussion is based in part on representations by the depositary and assumes that each obligation under the deposit agreement and any related agreement will be performed in accordance with its terms. Furthermore, the discussion below is based upon the provisions of the Internal Revenue Code of 1986, as amended (the “Code”), and U.S. Treasury regulations, rulings and judicial decisions hereunder as of the date hereof. Such authorities are subject to change, possibly on a retroactive basis, which may result in U.S. federal income tax consequences different from those discussed below.

A person considering an investment in our ADSs or ordinary shares is urged to consult its tax advisor concerning U.S. federal, state, local and non-U.S. income and other tax consequences.

A U.S. Holder is a beneficial owner of ADSs or ordinary shares that is for U.S. federal income tax purposes:

 

   

a citizen or resident individual of the United States;

 

   

a corporation or other entity taxable as a corporation created or organized in or under the laws of the United States, any state thereof, or the District of Columbia;

 

   

an estate the income of which is subject to U.S. federal income taxation, regardless of its source; or

 

   

a trust if it is subject to the primary supervision of a court within the United States and one or more U.S. persons have the authority to control all substantial decisions of the trust or has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.

A beneficial owner of ADSs or ordinary shares that is not a U.S. Holder is referred to herein as a “Non-U.S. Holder.”

If a partnership or limited liability company treated as a partnership for U.S. federal income tax purposes holds ADSs or ordinary shares, the tax treatment of a partner or member will generally depend on the status of the partner or member and the activities of the partnership or such limited liability company. A partner of a partnership or a member of such a limited liability company holding ADSs or ordinary shares is urged to consult its tax advisors regarding an investment in our ADSs or ordinary shares.

ADSs. In general, for U.S. federal income tax purposes, a U.S. Holder of ADSs will be treated as the owner of the underlying ordinary shares that are represented by such ADSs. Deposits and withdrawals of ordinary shares in exchange for ADSs will not be subject to U.S. federal income taxation.

Distributions on ADSs or ordinary shares. Unless the passive foreign investment company rules, as discussed below, apply, the gross amount of the distributions in respect of the ADSs or ordinary shares will be subject to tax as dividend income to the extent of our current and accumulated earnings and profits, as determined under U.S. federal income tax principles. Subject to certain limitations, dividends paid to non-corporate U.S. Holders, including individuals, may be eligible for a reduced rate of taxation if we are deemed to be a “qualified foreign corporation” for U.S. federal income tax purposes, provided that such holder satisfies certain holding period requirements with respect to the ownership of our ADSs or ordinary shares.

Subject to the exceptions discussed below, a corporation is a qualified foreign corporation if it is:

 

   

a foreign corporation that is eligible for the benefits of a comprehensive income tax treaty with the United States that includes an exchange of information program; or

 

   

a foreign corporation if its stock with respect to which a dividend is paid or its ADSs backed by such stock are readily tradable on an established securities market within the United States.

 

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Although we believe that we are a qualified foreign corporation because the ADSs will be traded on an established U.S. securities market and, as discussed below, we believe that we were not a passive foreign investment company for our 2018 tax year, no assurance can be given in this regard. In addition, our status as a qualified foreign corporation may change. A U.S. Holder that exchanges its ADSs for ordinary shares may not be eligible for the reduced rate of taxation on dividends if the ordinary shares are not deemed to be readily tradable on an established securities market within the United States.

Dividends will be includable in a U.S. Holder’s gross income on the date actually or constructively received by the depositary, in the case of ADSs or, in the case of ordinary shares, by such U.S. Holder. These dividends will not be eligible for the dividends-received deduction generally allowed to U.S. corporations in respect of dividends received from other U.S. corporations.

To the extent we pay dividends on the ADSs or ordinary shares in a currency other than the U.S. dollar, the U.S. dollar value of such dividends should be calculated by reference to the exchange rate prevailing on the date of actual or constructive receipt of the dividend, regardless of whether the foreign currency is converted into U.S. dollars at that time. If the foreign currency is converted into U.S. dollars on the date of actual or constructive receipt of such dividends, the tax basis of the U.S. Holder in such foreign currency will be equal to its U.S. dollar value on that date and, as a result, the U.S. Holder generally should not be required to recognize any foreign currency exchange gain or loss. Dividends paid in respect of the ADSs or ordinary shares generally will be treated as income from sources outside the United States.

To the extent that the amount of any distribution exceeds our current and accumulated earnings and profits, the distribution will first be treated as a tax-free return of capital, causing a reduction in the adjusted basis of the ADSs or ordinary shares, and the balance in excess of adjusted basis will be taxed as capital gain.

Sale, exchange or other disposition of ADSs or ordinary shares. Unless the passive foreign investment company rules, as discussed below, apply, upon the sale, exchange or other disposition of ADSs or ordinary shares a U.S. Holder generally will recognize capital gain or loss equal to the difference between the amount realized upon the sale, exchange or other disposition and the adjusted tax basis of the U.S. Holder in the ADSs or ordinary shares. The capital gain or loss generally will be long-term capital gain or loss if, at the time of sale, exchange or other disposition, the U.S. Holder has held the ADS or ordinary share for more than one year. Net long-term capital gains of non-corporate U.S. Holders, including individuals, are eligible for reduced rates of taxation. The deductibility of capital losses is subject to limitations. Any gain or loss that a U.S. Holder recognizes generally will be treated as gain or loss from sources within the United States for U.S. foreign tax credit limitation purposes.

Additional tax on net investment income. An additional 3.8% federal income tax may be assessed on net investment income (including dividends, other distributions, and gain realized on the sale of ADSs or ordinary shares) earned by certain U.S. Holders. This tax does not apply to U.S. Holders who hold ADSs or ordinary shares in the ordinary course of certain trades or businesses.

Passive foreign investment company rules. In general, we will be classified as a passive foreign investment company for any taxable year in which either (a) at least 75% of our gross income is passive income or (b) at least 50% of the value (determined on the basis of a quarterly average) of our assets is attributable to assets that produce or are held for the production of passive income. For this purpose, passive income generally includes dividends, interest, royalties, rents (other than rents and royalties derived in the active conduct of a trade or business and not derived from a related person), annuities and gains from assets that produce passive income. If we own directly or indirectly at least 25% by value of the equity shares of another corporation, we will be treated for purposes of the passive foreign investment company tests as owning a proportionate share of the assets of the other corporation, and as receiving directly a proportionate share of the other corporation’s income.

We believe, based on our present and projected composition of our income and valuation of our assets, we were not classified as a passive foreign investment company for U.S. federal income tax purposes for our 2018

 

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tax year, although no assurance can be given in this regard. Whether we are a passive foreign investment company for any particular taxable year is determined on an annual basis and will depend on the composition of our income and assets, including goodwill. The calculation of goodwill will be based, in part, on the then market value of our capital stock, which is subject to fluctuation. Accordingly, there can be no assurance that we will not be classified as a passive foreign investment company in the current or any future taxable year.

If we are a passive foreign investment company for any taxable year during which a U.S. Holder has an equity interest in our company, unless the U.S. Holder makes a mark-to-market election as discussed below, such U.S. Holder will be subject to special tax rules in any future taxable year regardless of whether we are classified as a passive foreign investment company in such future years with respect to (a) “excess distributions” and (b) gain from the disposition of stock. Excess distributions are defined generally as the excess of the amount received with respect to the equity interests in the taxable year over 125% of the average annual distributions received in the shorter of either the three previous years or a U.S. Holder’s holding period before the taxable year and must be allocated ratably to each day of the U.S. Holder’s holding period. The amount allocated to the current taxable year or any year before we became a passive foreign investment company will be included as ordinary income in a U.S. Holder’s gross income for that year. The amount allocated to other prior taxable years will be taxed as ordinary income at the highest rate in effect for a U.S. Holder in that prior year and the tax is subject to an interest charge at the rate applicable to deficiencies in income taxes. The entire amount of any gain realized upon the sale or other disposition of the equity interests will be treated as an excess distribution made in the year of sale or other disposition and as a consequence will be treated as ordinary income and, to the extent allocated to years prior to the year of sale or disposition with respect to which we were a passive foreign investment company, will be subject to the interest charge described above.

In certain circumstances, instead of being subject to the excess distribution rules discussed above, a U.S. Holder may make an election to include gain on the ADSs or ordinary shares of a passive foreign investment company as ordinary income under a mark-to-market method, provided that the ADSs or ordinary shares are regularly traded on a qualified exchange. Under current law, the mark-to-market election is only available for ADSs or ordinary shares that are regularly traded within the meaning of U.S. Treasury regulations on certain designated U.S. exchanges and foreign exchanges that meet trading, listing, financial disclosure and other requirements to be treated as a qualified exchange under applicable U.S. Treasury regulations. The Nasdaq Stock Market is a qualified exchange.

If a U.S. Holder makes a mark-to-market election, the U.S. Holder will include each year as ordinary income, rather than capital gain, the excess, if any, of the fair market value of the U.S. Holder’s ADSs or ordinary shares at the end of the taxable year over such U.S. Holder’s adjusted basis in the ADSs (or ordinary shares, if applicable) and will be permitted an ordinary loss in respect of the excess, if any, of the adjusted basis of these ADSs or ordinary shares over their fair market value at the end of the taxable year, but only to the extent of the net amount previously included in income as a result of the mark-to-market election. A U.S. Holder’s basis in the ADSs or ordinary shares will be adjusted to reflect any such income or loss amounts. Any gain or loss on the sale of the ADSs or ordinary shares will be ordinary income or loss, except that this loss will be ordinary loss only to the extent of the previously included net mark-to-market gain.

If we are a passive foreign investment company, then under certain circumstances a U.S. Holder must file Internal Revenue Service Form 8621.

Information Reporting and Back-up Withholding. The Foreign Account Tax Compliance Act (“FATCA”) generally requires that individuals that hold certain specified foreign financial assets worth in excess of certain thresholds of $50,000 or more, depending on the individual’s circumstances, report such ownership to the IRS using IRS Form 8938. The definition of specified foreign financial assets includes not only financial accounts maintained in foreign financial institutions, but also, unless held in accounts maintained by a financial institution, any stock or security issued by a non-U.S. person, any financial instrument or contract held for investment that has an issuer or counterparty other than a U.S. person and any interest in a foreign entity. A U.S. Holder may be

 

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subject to this reporting requirement unless such holder’s ADSs or ordinary shares are held in an account at a domestic financial institution. The penalty for failing to file Form 8938 is substantial.

U.S. holders generally are subject to information reporting requirements with respect to dividends on, or proceeds from the disposition of, our ordinary shares. In addition, a U.S. holder may be subject, under certain circumstances, to backup withholding at a rate of up to 24% with respect to dividends paid on, or proceeds from the disposition of, our ordinary shares unless the U.S. holder provides proof of an applicable exemption or correct taxpayer identification number, and otherwise complies with the applicable requirements of the backup withholding rules. A U.S. holder of our ordinary shares who provides an incorrect taxpayer identification number may be subject to penalties imposed by the IRS. Amounts withheld under the backup withholding rules are not an additional tax and may be refunded or credited against the U.S. holder’s U.S. federal income tax liability, provided the required information is furnished to the IRS.

A U.S. Holder is urged to consult its tax advisor concerning the U.S. federal income tax consequences of an investment in our ADSs or ordinary shares if we are or become a passive foreign investment company, including the possibility of making a mark-to-market election.

F. Dividends and Paying Agents

Not applicable.

G. Statement by Experts

The consolidated financial statements of Avita Medical Limited for the year ended June 30, 2018, 2017 and 2016 has been audited by Grant Thornton Audit Pty Ltd Level 43 Central Park, 152-158 St Georges Terrace Perth, WA 6000 Australia, an independent registered public accounting firm, as stated in their report appearing herein. The audited financial statements included in reliance upon the report of Grant Thornton Audit Pty Ltd, independent registered public accountants, upon the authority of said firm as experts in accounting and auditing.

H. Documents on Display

We will be subject to the reporting requirements of the United States Securities and Exchange Act of 1934, as amended, or the Exchange Act, as applicable to “foreign private issuers” as defined in Rule 3b-4 under the Exchange Act. As a foreign private issuer, we are exempt from certain provisions of the Exchange Act. Accordingly, our proxy solicitations are not subject to the disclosure and procedural requirements of regulation 14A under the Exchange Act, transactions in our equity securities by our officers and directors are exempt from reporting and the “short-swing” profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file periodic reports and financial statements as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we will file with the U.S. Securities and Exchange Commission an annual report on Form 20-F containing financial statements that have been examined and reported on, with and opinion expressed by an independent registered public accounting firm, and we will submit reports to the U.S. Securities and Exchange Commission on Form 6-K containing (among other things) press releases and unaudited financial information for the first six months of each fiscal year. We post our annual report on Form 20-F on our website promptly following the filing of our annual report with the U.S. Securities and Exchange Commission. The information on our website is not incorporated by reference into this annual report.

This document and the exhibits thereto and any other document we file pursuant to the Exchange Act may be inspected without charge and copied at prescribed rates at the U.S. Securities and Exchange Commission public reference room at 100 F Street, N.E., Room 1580, Washington D.C. 20549. You may obtain information on the operation of the Securities and Exchange Commission’s public reference room in Washington, D.C. by calling the U.S. Securities and Exchange Commission at 1-800-SEC-0330.

 

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The U.S. Securities and Exchange Commission maintains a website at www.sec.gov that contains reports, proxy and information statements and other information regarding registrants that make electronic filings with the U.S. Securities and Exchange Commission using its EDGAR (Electronic Data Gathering, Analysis, and Retrieval) system.

The documents concerning our company that are referred to in this document may also be inspected at the offices located at Level 7, 330 Collins Street, Melbourne VIC 3000 Australia.

I. Subsidiary Information

See Item 4C, under the heading “Organizational Structure.

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Please see the Company’s audited financial statements for the year ended June 20, 2018, at Item 18 under Note 19 “Financial Risk management Objectives and Policies” for a description of interest rate risk, foreign currency risk, credit risk and liquidity risk and how such risks affect the Company.

ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

A. Debt Securities

Not applicable.

B. Warrants and Rights

Not applicable.

C. American Depositary Shares

The Bank of New York Mellon, as depositary, will register and deliver American Depositary Shares, also referred to as ADSs. Each ADS will represent 20 shares (or a right to receive 20 shares) deposited with National Australia Bank Ltd., as custodian for the depositary in Melbourne, Australia. Each ADS will also represent any other securities, cash or other property which may be held by the depositary. The deposited shares together with any other securities, cash or other property held by the depositary are referred to as the deposited securities. The depositary’s office at which the ADSs will be administered and its principal executive office are located at 240 Greenwich Street, New York, New York 10286.

You may hold ADSs either (A) directly (i) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs, registered in your name, or (ii) by having uncertificated ADSs registered in your name, or (B) indirectly by holding a security entitlement in ADSs through your broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. If you hold ADSs directly, you are a registered ADS holder, also referred to as an ADS holder. This description assumes you are an ADS holder. If you hold the ADSs indirectly, you must rely on the procedures of your broker or other financial institution to assert the rights of ADS holders described in this section. You should consult with your broker or financial institution to find out what those procedures are.

Registered holders of uncertificated ADSs will receive statements from the depositary confirming their holdings.

As an ADS holder, we will not treat you as one of our shareholders and you will not have shareholder rights. Australian law governs shareholder rights. The depositary will be the holder of the shares underlying your ADSs.

 

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As a registered holder of ADSs, you will have ADS holder rights. A deposit agreement among us, the depositary, ADS holders and all other persons indirectly or beneficially holding ADSs sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs.

The following is a summary of the material provisions of the deposit agreement. For more complete information, you should read the entire deposit agreement and the form of ADR.

Dividends and Other Distributions

How will you receive dividends and other distributions on the shares?

The depositary has agreed to pay or distribute to ADS holders the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, upon payment or deduction of its fees and expenses. You will receive these distributions in proportion to the number of shares your ADSs represent.

Cash. The depositary will convert any cash dividend or other cash distribution we pay on the shares into U.S. dollars, if it can do so on a reasonable basis and can transfer the U.S. dollars to the United States. If that is not possible or if any government approval is needed and cannot be obtained, the deposit agreement allows the depositary to distribute the foreign currency only to those ADS holders to whom it is possible to do so. It will hold the foreign currency it cannot convert for the account of the ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any interest.

Before making a distribution, any withholding taxes, or other governmental charges that must be paid will be deducted. See Item 10D “Exchange Controls and Australian Tax Matters” and Item 10E “U.S. Federal Income Tax Considerations” for more information. The depositary will distribute only whole U.S. dollars and cents and will round fractional cents to the nearest whole cent. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, you may lose some of the value of the distribution.

Shares. The depositary may distribute additional ADSs representing any shares we distribute as a dividend or free distribution. The depositary will only distribute whole ADSs. It will sell shares which would require it to deliver a fraction of an ADS (or ADSs representing those shares) and distribute the net proceeds in the same way as it does with cash. If the depositary does not distribute additional ADSs, the outstanding ADSs will also represent the new shares. The depositary may sell a portion of the distributed shares (or ADSs representing those shares) sufficient to pay its fees and expenses in connection with that distribution.

Rights to purchase additional shares. If we offer holders of our securities any rights to subscribe for additional shares or any other rights, the depositary may (i) exercise those rights on behalf of ADS holders, (ii) distribute those rights to ADS holders or (iii) sell those rights and distribute the net proceeds to ADS holders, in each case after deduction or upon payment of its fees and expenses. To the extent the depositary does not do any of those things, it will allow the rights to lapse. In that case, you will receive no value for them. The depositary will exercise or distribute rights only if we ask it to and provide satisfactory assurances to the depositary that it is legal to do so. If the depositary will exercise rights, it will purchase the securities to which the rights relate and distribute those securities or, in the case of shares, new ADSs representing the new shares, to subscribing ADS holders, but only if ADS holders have paid the exercise price to the depositary. U.S. securities laws may restrict the ability of the depositary to distribute rights or ADSs or other securities issued on exercise of rights to all or certain ADS holders, and the securities distributed may be subject to restrictions on transfer.

Other Distributions. The depositary will send to ADS holders anything else we distribute on deposited securities by any means it thinks is legal, fair and practical. If it cannot make the distribution in that way, the depositary has a choice. It may decide to sell what we distributed and distribute the net proceeds, in the same way as it does with cash. Or, it may decide to hold what we distributed, in which case ADSs will also represent the newly distributed property. However, the depositary is not required to distribute any securities (other than ADSs)

 

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to ADS holders unless it receives satisfactory evidence from us that it is legal to make that distribution. The depositary may sell a portion of the distributed securities or property sufficient to pay its fees and expenses in connection with that distribution. U.S. securities laws may restrict the ability of the depositary to distribute securities to all or certain ADS holders, and the securities distributed may be subject to restrictions on transfer.

The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. We have no obligation to register ADSs, shares, rights or other securities under the Securities Act. We also have no obligation to take any other action to permit the distribution of ADSs, shares, rights or anything else to ADS holders. This means that you may not receive the distributions we make on our shares or any value for them if it is illegal or impractical for us to make them available to you.

Deposit, Withdrawal and Cancellation

How are ADSs issued?

The depositary will deliver ADSs if you or your broker deposits shares or evidence of rights to receive shares with the custodian. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will register the appropriate number of ADSs in the names you request and will deliver the ADSs to or upon the order of the person or persons that made the deposit.

How can ADS holders withdraw the deposited securities?

You may surrender your ADSs to the depositary for the purpose of withdrawal. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will deliver the shares and any other deposited securities underlying the ADSs to the ADS holder or a person the ADS holder designates at the office of the custodian. Or, at your request, risk and expense, the depositary will deliver the deposited securities at its office, if feasible. However, the depositary is not required to accept surrender of ADSs to the extent it would require delivery of a fraction of a deposited share or other security. The depositary may charge you a fee and its expenses for instructing the custodian regarding delivery of deposited securities.

How do ADS holders interchange between certificated ADSs and uncertificated ADSs?

You may surrender your ADR to the depositary for the purpose of exchanging your ADR for uncertificated ADSs. The depositary will cancel that ADR and will send to the ADS holder a statement confirming that the ADS holder is the registered holder of uncertificated ADSs. Upon receipt by the depositary of a proper instruction from a registered holder of uncertificated ADSs requesting the exchange of uncertificated ADSs for certificated ADSs, the depositary will execute and deliver to the ADS holder an ADR evidencing those ADSs.

Voting Rights

How do you vote?

ADS holders may instruct the depositary how to vote the number of deposited shares their ADSs represent. If we request the depositary to solicit your voting instructions (and we are not required to do so), the depositary will notify you of a shareholders’ meeting and send or make voting materials available to you. Those materials will describe the matters to be voted on and explain how ADS holders may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary. The depositary will try, as far as practical, subject to the laws of the Commonwealth of Australia and the provisions of our articles of association or similar documents, to vote or to have its agents vote the shares or other deposited securities as instructed by ADS holders. If we do not request the depositary to solicit your voting instructions, you can still send voting instructions, and, in that case, the depositary may try to vote as you instruct, but it is not required to do so.

 

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Except by instructing the depositary as described above, you won’t be able to exercise voting rights unless you surrender your ADSs and withdraw the shares. However, you may not know about the meeting enough in advance to withdraw the shares. In any event, the depositary will not exercise any discretion in voting deposited securities and it will only vote or attempt to vote as instructed.

We cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means that you may not be able to exercise voting rights and there may be nothing you can do if your shares are not voted as you requested.

In order to give you a reasonable opportunity to instruct the depositary as to the exercise of voting rights relating to Deposited Securities, if we request the Depositary to act, we agree to give the depositary notice of any such meeting and details concerning the matters to be voted upon at least 45 days in advance of the meeting date.

Fees and Expenses

 

Persons depositing  or withdrawing shares

or ADS  holders must pay:

   For:
$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)   

Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property

 

Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates

$.05 (or less) per ADS    Any cash distribution to ADS holders
A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs    Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders
$.05 (or less) per ADS per calendar year    Depositary services
Registration or transfer fees    Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares
Expenses of the depositary   

Cable and facsimile transmissions (when expressly provided in the deposit agreement)

 

Converting foreign currency to U.S. dollars

Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes    As necessary
Any charges incurred by the depositary or its agents for servicing the deposited securities    As necessary

The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid.

 

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From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally arising out of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its duties under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the depositary and that may earn or share fees, spreads or commissions.

The depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The depositary makes no representation that the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be determined will be the most favorable to ADS holders, subject to the depositary’s obligations under the deposit agreement. The methodology used to determine exchange rates used in currency conversions is available upon request.

Payment of Taxes

You will be responsible for any taxes or other governmental charges payable on your ADSs or on the deposited securities represented by any of your ADSs. The depositary may refuse to register any transfer of your ADSs or allow you to withdraw the deposited securities represented by your ADSs until those taxes or other charges are paid. It may apply payments owed to you or sell deposited securities represented by your ADSs to pay any taxes owed and you will remain liable for any deficiency. If the depositary sells deposited securities, it will, if appropriate, reduce the number of ADSs to reflect the sale and pay to ADS holders any proceeds, or send to ADS holders any property, remaining after it has paid the taxes.

Tender and Exchange Offers; Redemption, Replacement or Cancellation of Deposited Securities

The depositary will not tender deposited securities in any voluntary tender or exchange offer unless instructed to do by an ADS holder surrendering ADSs and subject to any conditions or procedures the depositary may establish.

If deposited securities are redeemed for cash in a transaction that is mandatory for the depositary as a holder of deposited securities, the depositary will call for surrender of a corresponding number of ADSs and distribute the net redemption money to the holders of called ADSs upon surrender of those ADSs.

If there is any change in the deposited securities such as a sub-division, combination or other reclassification, or any merger, consolidation, recapitalization or reorganization affecting the issuer of deposited securities in which the depositary receives new securities in exchange for or in lieu of the old deposited securities, the depositary will hold those replacement securities as deposited securities under the deposit agreement. However, if the depositary decides it would not be lawful and practical to hold the replacement securities because those securities could not be distributed to ADS holders or for any other reason, the depositary may instead sell the replacement securities and distribute the net proceeds upon surrender of the ADSs.

If there is a replacement of the deposited securities and the depositary will continue to hold the replacement securities, the depositary may distribute new ADSs representing the new deposited securities or ask you to surrender your outstanding ADRs in exchange for new ADRs identifying the new deposited securities.

If there are no deposited securities underlying ADSs, including if the deposited securities are cancelled, or if the deposited securities underlying ADSs have become apparently worthless, the depositary may call for surrender or of those ADSs or cancel those ADSs upon notice to the ADS holders.

 

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Amendment and Termination

How may the deposit agreement be amended?

We may agree with the depositary to amend the deposit agreement and the ADRs without your consent for any reason. If an amendment adds or increases fees or charges, except for taxes and other governmental charges or expenses of the depositary for registration fees, facsimile costs, delivery charges or similar items, or prejudices a substantial right of ADS holders, it will not become effective for outstanding ADSs until 30 days after the depositary notifies ADS holders of the amendment. At the time an amendment becomes effective, you are considered, by continuing to hold your ADSs, to agree to the amendment and to be bound by the ADRs and the deposit agreement as amended.

How may the deposit agreement be terminated?

The depositary will initiate termination of the deposit agreement if we instruct it to do so. The depositary may initiate termination of the deposit agreement if

 

   

60 days have passed since the depositary told us it wants to resign but a successor depositary has not been appointed and accepted its appointment;

 

   

we delist our shares from an exchange on which they were listed and do not list the shares on another exchange;

 

   

we appear to be insolvent or enter insolvency proceedings

 

   

all or substantially all the value of the deposited securities has been distributed either in cash or in the form of securities;

 

   

there are no deposited securities underlying the ADSs or the underlying deposited securities have become apparently worthless; or

 

   

there has been a replacement of deposited securities.

If the deposit agreement will terminate, the depositary will notify ADS holders at least 90 days before the termination date. At any time after the termination date, the depositary may sell the deposited securities. After that, the depositary will hold the money it received on the sale, as well as any other cash it is holding under the deposit agreement, unsegregated and without liability for interest, for the pro rata benefit of the ADS holders that have not surrendered their ADSs. Normally, the depositary will sell as soon as practicable after the termination date.

After the termination date and before the depositary sells, ADS holders can still surrender their ADSs and receive delivery of deposited securities, except that the depositary may refuse to accept a surrender for the purpose of withdrawing deposited securities or reverse previously accepted surrenders of that kind that have not settled if it would interfere with the selling process. The depositary may refuse to accept a surrender for the purpose of withdrawing sale proceeds until all the deposited securities have been sold. The depositary will continue to collect distributions on deposited securities, but, after the termination date, the depositary is not required to register any transfer of ADSs or distribute any dividends or other distributions on deposited securities to the ADSs holder (until they surrender their ADSs) or give any notices or perform any other duties under the deposit agreement except as described in this paragraph.

Limitations on Obligations and Liability

Limits on our Obligations and the Obligations of the Depositary; Limits on Liability to Holders of ADSs

The deposit agreement expressly limits our obligations and the obligations of the depositary. It also limits our liability and the liability of the depositary. We and the depositary:

 

   

are only obligated to take the actions specifically set forth in the deposit agreement without negligence or bad faith, and the depositary will not be a fiduciary or have any fiduciary duty to holders of ADSs;

 

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are not liable if we are or it is prevented or delayed by law or by events or circumstances beyond our or its control from performing our or its obligations under the deposit agreement;

 

   

are not liable if we or it exercises discretion permitted under the deposit agreement;

 

   

are not liable for the inability of any holder of ADSs to benefit from any distribution on deposited securities that is not made available to holders of ADSs under the terms of the deposit agreement, or for any special, consequential or punitive damages for any breach of the terms of the deposit agreement;

 

   

have no obligation to become involved in a lawsuit or other proceeding related to the ADSs or the deposit agreement on your behalf or on behalf of any other person;

 

   

may rely upon any documents we believe or it believes in good faith to be genuine and to have been signed or presented by the proper person;

 

   

are not liable for the acts or omissions of any securities depository, clearing agency or settlement system; and

 

   

the depositary has no duty to make any determination or provide any information as to our tax status, or any liability for any tax consequences that may be incurred by ADS holders as a result of owning or holding ADSs or be liable for the inability or failure of an ADS holder to obtain the benefit of a foreign tax credit, reduced rate of withholding or refund of amounts withheld in respect of tax or any other tax benefit.

In the deposit agreement, we and the depositary agree to indemnify each other under certain circumstances.

Requirements for Depositary Actions

Before the depositary will deliver or register a transfer of ADSs, make a distribution on ADSs, or permit withdrawal of shares, the depositary may require:

 

   

payment of stock transfer or other taxes or other governmental charges and transfer or registration fees charged by third parties for the transfer of any shares or other deposited securities;

 

   

satisfactory proof of the identity and genuineness of any signature or other information it deems necessary; and

 

   

compliance with regulations it may establish, from time to time, consistent with the deposit agreement, including presentation of transfer documents.

The depositary may refuse to deliver ADSs or register transfers of ADSs when the transfer books of the depositary or our transfer books are closed or at any time if the depositary or we think it advisable to do so.

Your Right to Receive the Shares Underlying your ADSs

ADS holders have the right to cancel their ADSs and withdraw the underlying shares at any time except:

 

   

when temporary delays arise because: (i) the depositary has closed its transfer books or we have closed our transfer books; (ii) the transfer of shares is blocked to permit voting at a shareholders’ meeting; or (iii) we are paying a dividend on our shares;

 

   

when you owe money to pay fees, taxes and similar charges; or

 

   

when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of shares or other deposited securities.

This right of withdrawal may not be limited by any other provision of the deposit agreement.

 

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Direct Registration System

In the deposit agreement, all parties to the deposit agreement acknowledge that the Direct Registration System, also referred to as DRS, and Profile Modification System, also referred to as Profile, will apply to the ADSs. DRS is a system administered by DTC that facilitates interchange between registered holding of uncertificated ADSs and holding of security entitlements in ADSs through DTC and a DTC participant. Profile is a feature of DRS that allows a DTC participant, claiming to act on behalf of a registered holder of uncertificated ADSs, to direct the depositary to register a transfer of those ADSs to DTC or its nominee and to deliver those ADSs to the DTC account of that DTC participant without receipt by the depositary of prior authorization from the ADS holder to register that transfer.

In connection with and in accordance with the arrangements and procedures relating to DRS/Profile, the parties to the deposit agreement understand that the depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an ADS holder in requesting registration of transfer and delivery as described in the paragraph above has the actual authority to act on behalf of the ADS holder (notwithstanding any requirements under the Uniform Commercial Code). In the deposit agreement, the parties agree that the depositary’s reliance on and compliance with instructions received by the depositary through the DRS/Profile system and in accordance with the deposit agreement will not constitute negligence or bad faith on the part of the depositary.

Shareholder communications; inspection of register of holders of ADSs

The depositary will make available for your inspection at its office all communications that it receives from us as a holder of deposited securities that we make generally available to holders of deposited securities. The depositary will send you copies of those communications or otherwise make those communications available to you if we ask it to. You have a right to inspect the register of holders of ADSs, but not for the purpose of contacting those holders about a matter unrelated to our business or the ADSs.

Jury Trial Waiver

The deposit agreement provides that, to the extent permitted by law, ADS holders waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to our shares, the ADSs or the deposit agreement, including any claim under the U.S. federal securities laws. If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable in the facts and circumstances of that case in accordance with applicable case law. Notwithstanding the foregoing, ADS holders cannot waive compliance with federal securities laws and the rules and regulations promulgated thereunder.

D. Other Securities

Not applicable.

 

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PART II

ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES

Not applicable.

ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS

Not applicable.

ITEM 15. CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Not applicable.

Changes in Internal Control over Financial Reporting

During the year ended June 30, 2018, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

ITEM 16. RESERVED

Not applicable.

ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT

Not applicable.

ITEM 16B. CODE OF ETHICS

Not applicable.

ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES

Not applicable.

ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

Not applicable.

ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS

Not applicable.

ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT

Not applicable.

ITEM 16G. CORPORATE GOVERNANCE

Not applicable.

 

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ITEM 16H. MINE SAFETY DISCLOSURES

Not applicable.

 

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PART III

ITEM 17. FINANCIAL STATEMENTS

The following financial statements and notes thereto (as applicable) in Australian dollars are filed with and incorporated herein as part of this registration statement on Form 20-F, beginning on page F-1 following the signature page of this Form 20-F:

 

   

audited consolidated financial statements of the Company for the years ended June 30, 2018, 2017 and 2016, prepared in accordance with IFRS as issued by the IASB, including: consolidated statements of profits or loss and other comprehensive loss, consolidated statements of financial position, consolidated statements of cash flows, consolidated statements of changes in equity and notes to the consolidated financial statements.

 

   

Unaudited condensed consolidated financial statements of the Company for the half-year ended December 31, 2018 and 2017, prepared in accordance with IFRS as issued by the IASB, including, including: consolidated statements of profits or loss and other comprehensive loss, consolidated statements of financial position, consolidated statements of cash flows, consolidated statements of changes in equity and notes to the consolidated financial statements.

 

   

In addition, Exhibit 15.1 included with this registration statement on Form 20-F contains the preliminary, unaudited consolidated statements of profits or loss and other comprehensive income, consolidated statements of financial position, consolidated statements of cash flows and consolidated statements of changes in equity for the fiscal year ended June 30, 2019 as submitted as Appendix 4E in connection with the ongoing listing of our ordinary shares on the Australian Securities Exchange. The results presented in Exhibit 15.1 are preliminary in nature, have not been audited, and are subject to change and should not be relied on as indicative of actual results for the year ended June 30, 2019.

ITEM 18. FINANCIAL STATEMENTS

We have elected to provide financial statements pursuant to Item 17. See the Index to the Financial Statements on page F-1 following the signature page of this Form 20-F.

ITEM 19. EXHIBITS

The following exhibits are filed as part of this registration statement:

 

Exhibit    Description
  1.1    Corporations Act Constitution of Avita Medical Limited
  2.1    Form of Deposit Agreement among the registrant, The Bank of New York Mellon, as Depositary, and all owners and holders from time to time of American Depositary Shares issued thereunder
  4.1    Employee Incentive Option Plan
  4.2    Employee Share Plan
  4.3 +    Award/Contract, dated September 29, 2015 by and between the registrant and the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA)
  4.4 +    Award/Contract, dated September 29, 2015, by and between the registrant and BARDA
  4.5 +    Amendment of Solicitation/Modification of Contract, dated June 24, 2016, by and between the registrant and BARDA
  4.6 +    Amendment of Solicitation/Modification of Contract, dated September 28, 2017, by and between the registrant and BARDA
  4.7 +    Amendment of Solicitation/Modification of Contract, dated July 2, 2018, by and between the registrant and BARDA
  4.8    Lease Agreement between the registrant and Hartco Ventura Inc., dated January 25, 2018
  4.9    Lease Agreement between the registrant and RIF III – Avenue Stanford, LLC, dated October 3, 2016, as amended

 

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Exhibit    Description
  8.1    List of subsidiaries of the registrant
15.1    Preliminary unaudited final report of June 30, 2019; results announced to the Australian market on August 30, 2019

 

+

Confidential treatment has been requested as to certain portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.

 

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SIGNATURES

The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this registration statement on its behalf.

 

Avita Medical Limited

 

/s/ Michael Perry

By: Michael Perry
Title: Chief Executive Officer

Date: September 19, 2019

 

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INDEX TO THE FINANCIAL STATEMENTS

Avita Medical Limited

INDEX TO AUDITED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2018, 2017 AND 2016

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

     F-2  

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE LOSS FOR THE YEARS ENDED JUNE 30, 2018, 2017 AND 2016

     F-4  

CONSOLIDATED STATEMENT OF FINANCIAL POSITION AS OF JUNE  30, 2018 AND 2017

     F-5  

CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEAR ENDED JUNE  30, 2018, 2017 AND 2016

     F-6  

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY AS OF JUNE  30, 2018, 2017 AND 2016

     F-7 to F-9  

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED JUNE  30, 2018, 2017 AND 2016

     F-10 to F-52  

INDEX TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2018 AND FOR THE HALF-YEAR ENDED DECEMBER 31, 2018 AND 2017

 

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE LOSS FOR THE HALF-YEAR ENDED DECEMBER 31, 2018 AND 2017 (UNAUDITED)

     F-53  

CONSOLIDATED FINANCIAL POSITION AS OF DECEMBER 31, 2018 AND 30  JUNE 2018 (UNAUDITED)

     F-54  

CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE HALF-YEAR ENDED DECEMBER  31, 2018 AND 2017 (UNAUDITED)

     F-55  

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY AS OF DECEMBER  31, 2018 AND 2017 (UNAUDITED)

     F-56  

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS FOR THE HALF-YEAR ENDED DECEMBER 31, 2018 AND 2017 (UNAUDITED)

     F-57 to F-66  

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

  

Board of Directors and Shareholders

Avita Medical Ltd.

 

Opinion on the financial statements

 

We have audited the accompanying consolidated statement of financial position of Avita Medical Ltd. and subsidiaries (the “Company”) as of June, 30 2018 and 2017, the related consolidated statements of profit or loss and other comprehensive income, consolidated changes in equity, and consolidated statement of cash flows for each of the three years in the period ended June 30, 2018 and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of June 30, 2018 and 2017, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2018, in conformity with International Financial Reporting Standards, as issued by the International Accounting Standards Board.

 

Basis for opinion

 

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

  

 

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

/s/ GRANT THORNTON AUDIT PTY LTD

 

We have served as the Company’s auditor since 2011.

 

Perth, Western Australia

September 19, 2019

 

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Consent of Independent Registered Public Accounting Firm

We have issued our report dated September 19, 2019 with respect to the consolidated financial statements of Avita Medical Ltd contained in the Registration Statement. We consent to the use of the aforementioned report in the Registration Statement and to the use of our name as it appears under the caption “Experts.”

/s/ GRANT THORNTON AUDIT PTY LTD

Perth, Western Australia, Australia

September 19, 2019

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER COMPREHENSIVE LOSS

(IN AUSTRALIAN DOLLARS)

 

          Year Ended June 30,  
    Notes     2018     2017     2016  

Continuing operations

       

Sale of goods

    4     A$ 1,198,861     A$ 901,376     A$ 1,002,007  

Cost of sales

    4       (511,646     (463,285     (401,568
   

 

 

   

 

 

   

 

 

 

Gross profit

      687,215       438,091       600,439  

BARDA income

    4       10,104,081       6,886,236       2,424,357  

Other income

    4       68,617       344,734       120,160  
   

 

 

   

 

 

   

 

 

 

Total other income

      10,172,698       7,230,970       2,544,517  

Operating costs

       

Sales and marketing expenses

      (8,936,441     (5,201,761     (5,042,189

Product development expenses

      (12,606,127     (11,161,970     (6,018,184

Corporate and administrative expenses

      (5,360,553     (2,264,594     (2,371,747

Share-based payment expenses

    18       (1,835,157     (1,587,243     (956,658

Finance costs

    4       (26,586     (12,754     (21
   

 

 

   

 

 

   

 

 

 

Total operating costs

      (28,764,864     (20,228,322     (14,388,799
   

 

 

   

 

 

   

 

 

 

Loss from continuing operations before income tax benefit

      (17,904,951     (12,559,261     (11,243,843

Profit for the period from discontinued operations

      —         —         2,493,947  

Income tax benefit (net)

    6       1,385,796       1,048,237       971,881  
   

 

 

   

 

 

   

 

 

 

Loss for the period

    5       (16,519,155     (11,511,024     (7,778,015

Other comprehensive income (loss)

       

Items that may be reclassified subsequently to profit and loss:

       

Foreign currency translation

      563,279       (83,293     (169,100

Fair value gain on available for sale financial assets

      —         (265,261     265,261  
   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss) for the period, net of tax

      563,279       (348,554     96,161  
   

 

 

   

 

 

   

 

 

 

Total other comprehensive loss for the period

    A$ (15,955,876   A$ (11,859,578   A$ (7,681,854
   

 

 

   

 

 

   

 

 

 

Loss for the period attributable to owners of the parent

      (16,519,155     (11,511,024     (7,778,015
   

 

 

   

 

 

   

 

 

 

Total comprehensive loss attributable to owners of the parent

    A$ (15,955,876   A$ (11,859,578   A$ (7,681,854
   

 

 

   

 

 

   

 

 

 
Continuing Operations        

Basic loss per share attributable to ordinary equity holders of the parent

    5     A$ (1.77) cents     A$ (1.72) cents     A$ (1.56) cents  

Diluted loss per share attributable to ordinary equity holders of the parent

    5     A$ (1.77) cents     A$ (1.72) cents     A$ (1.56) cents  
Discontinued Operations        

Basic loss per share attributable to ordinary equity holders of the parent

    5       —         —       A$ (0.05) cents  

Diluted loss per share attributable to ordinary equity holders of the parent

    5       —         —       A$ (0.05) cents  

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

(IN AUSTRALIAN DOLLARS)

 

            June 30,  
     Notes      2018     2017  

ASSETS

       

Current assets

       

Cash and cash equivalents

     7      A$ 14,825,532     A$ 3,790,491  

Trade and other receivables

     8        5,437,357       2,070,534  

Prepayments and other assets

        855,716       382,026  

Inventories

     9        1,155,826       1,037,490  
     

 

 

   

 

 

 

Total current assets

        22,274,431       7,280,541  
     

 

 

   

 

 

 

Non-current assets

       

Plant and equipment

     10        742,583       387,380  
     

 

 

   

 

 

 

Total non-current assets

        742,583       387,380  
     

 

 

   

 

 

 

TOTAL ASSETS

      A$ 23,017,014     A$ 7,667,921  
     

 

 

   

 

 

 

LIABILITIES

       

Current liabilities

       

Trade and other payables

     11        3,487,582       2,363,734  

Provisions

     12        395,535       182,355  
     

 

 

   

 

 

 

Total current liabilities

        3,883,117       2,546,089  
     

 

 

   

 

 

 

Finance lease

        134,338       —    
     

 

 

   

 

 

 

Total non-current liabilities

        134,338       —    
     

 

 

   

 

 

 

TOTAL LIABILITIES

      A$ 4,017,455     A$ 2,546,089  
     

 

 

   

 

 

 

NET ASSETS

      A$ 18,999,559     A$ 5,121,832  
     

 

 

   

 

 

 

EQUITY

       

Equity attributable to equity holders of the parent:

       

Contributed equity

     13        162,801,028       134,806,022  

Accumulated losses

     14        (148,592,879     (132,218,352

Reserves

        4,791,410       2,534,162  
     

 

 

   

 

 

 

TOTAL EQUITY

      A$ 18,999,559     A$ 5,121,832  
     

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENT OF CASH FLOWS

(IN AUSTRALIAN DOLLARS)

 

          Year Ended June 30,  
     Notes    2018     2017     2016  

Cash flows from operating activities

         

Payments to suppliers and employees

      A$ (25,681,347   A$ (17,676,710   A$ (14,894,221

Interest paid

        (26,586     (12,754     (21

BARDA receipts and other income received

        8,141,207       7,094,061       2,427,188  

Receipts from customers

        1,129,046       928,687       1,079,549  

R&D tax refund received

        —         972,283       654,060  

Interest received

        65,656       123,709       110,364  

Government grants received

        —         13,200       6,965  

Proceeds from disposal of discontinued operations

        —         —         2,029,478  

Net cash from discontinued operations

        —         —         648,081  
     

 

 

   

 

 

   

 

 

 

Net cash flows used in operating activities

   15      (16,372,024     (8,557,524     (7,938,557
     

 

 

   

 

 

   

 

 

 

Cash flows from investing activities

         

Payments for plant and equipment

        (498,749     (432,592     (48,289

Proceeds from the sale of financial assets

        —         627,837       —    

Proceeds from disposal of plant and equipment

        —         —         440  
     

 

 

   

 

 

   

 

 

 

Net cash flows (used in)/provided by investing activities

        (498,749     195,245       (47,849
     

 

 

   

 

 

   

 

 

 

Cash flows from financing activities

         

Proceeds from issuance of shares and options

        29,760,563       9,048,102       10,025,584  

Capital raising expenses

        (1,825,643     (506,452     (664,754

Purchase of finance leased asset

        —         (303,521     —    
     

 

 

   

 

 

   

 

 

 

Net cash flows provided by financing activities

        27,934,920       8,238,129       9,360,830  
     

 

 

   

 

 

   

 

 

 

Net increase/(decrease) in cash and cash equivalents

        11,064,147       (124,150     1,374,424  

Cash and cash equivalents at beginning of period

        3,790,491       4,171,879       2,966,555  

Impact of foreign exchange

        (29,106     (257,238     (169,100
     

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at end of period

   7    A$ 14,825,532     A$ 3,790,491     A$ 4,171,879  
     

 

 

   

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

(IN AUSTRALIAN DOLLARS)

 

    Contributed
equity
    Accumulated
losses
    Share-based
payment reserve
    Foreign
currency
translation
reserve
    Total  

At July 1, 2017

  A$ 134,806,022     A$ (132,218,352   A$ 2,811,179     A$ (277,017   A$ 5,121,832  

Loss for the period

    —         (16,519,155     —         —         (16,519,155

Other comprehensive income

         

Foreign currency translation

    —         —         —         563,279       563,279  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

    —         (16,519,155     —         563,279       (15,955,876
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

         

Expired options

    —         141,188       (141,188     —         —    

Forfeiture options

    —         3,440       (31,832     —         (28,392

Share-based payments

    —         —         1,866,989       —         1,866,989  

New shares

    29,846,859       —         —         —         29,846,859  

Cost of share placement

    (1,851,853     —         —         —         (1,851,853
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at June 30, 2018

  A$ 162,801,028     A$ (148,592,879   A$ 4,505,148     A$ 286,262     A$ 18,999,559  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

    Contributed
equity
    Accumulated
losses
    Employee
equity benefit
reserve
    Available
for sale
reserve
    Foreign
currency
translation
reserve
    Total  

At July 1, 2016

  A$ 126,264,372     A$ (121,108,408   A$ 1,625,016     A$ 265,261     A$ (193,724   A$ 6,852,517  

Loss for the period

    —         (11,511,024     —         —         —         (11,511,024

Other comprehensive income

           

Foreign currency translation

    —         —         —         —         (83,293     (83,293

MVP Shares

    —         —         —         (265,261     —         (265,261
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

    —         (11,511,024     —         (265,261     (83,293     (11,859,578
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

           

Expired Options

    —         401,080       (401,080     —         —         —    

Share-based expenses

    —         —         1,587,243       —         —         1,587,243  

New shares

    9,048,102       —         —         —         —         9,048,102  

Cost of share placement

    (506,452     —         —         —         —         (506,452
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at June 30, 2017

  A$ 134,806,022     A$ (132,218,352   A$ 2,811,179     A$ —       A$ (277,017   A$ 5,121,832  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENT OF CHANGES IN EQUITY (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

    Contributed
equity
    Accumulated
losses
    Employee
equity benefit
reserve
    Available
for sale
reserve
    Foreign
currency
translation
reserve
    Total  

At July 1, 2015

  A$ 117,044,332     A$ (113,457,640   A$ 654,816     A$ —       A$ (24,624   A$ 4,216,884  

Loss for the period

    —         (7,778,015     —         —         —         (7,778,015

Other comprehensive income

    —         —         —         —         —         —    

- Foreign currency translation

    —         —         —         —         (169,100     (169,100
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

    —         (7,778,015     —         —         (169,100     (7,947,115
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

           

Expired options

    —         127,247       (127,247     —         —         —    

Share-based expenses

    —         —         956,658       —         —         956,658  

MVP shares

    —         —         —         265,261       —         265,261  

New options

    —         —         140,789       —         —         140,789  

New shares

    10,025,584       —         —         —         —         10,025,584  

Cost of share placement

    (805,544     —         —         —         —         (805,544
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at June 30, 2016

  A$ 126,264,372     A$ (121,108,408   A$ 1,625,016     A$ 265,261     A$ (193,724   A$ 6,852,517  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

F-9


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

 

1.

CORPORATE INFORMATION

Avita Medical Limited, the parent entity, is a company limited by shares incorporated in Australia whose shares are publicly traded on the Australian Securities Exchange.

The nature of the operations and principal activities of the Company are described in the Business Overview.

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

a)

Basis of preparation and statement of compliance

The consolidated financial statements are general purpose consolidated financial statements that have been prepared in accordance with the requirements of the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). The Company’s consolidated financial statements include the assets and liabilities of all subsidiaries of the Company as at June 30, 2018 and the results of the subsidiaries for the year then ended. Inter-entity transactions with, or between, subsidiaries are eliminated in full on consolidation.

Except for cash flow information, the financial report has been prepared on an accrual basis and is based on historical costs, modified, where applicable, for financial liabilities and assets held at fair value through profit or loss and is presented in Australian dollars which is the Company’s functional and presentation currency.

 

b)

New and amended accounting standards and interpretations adopted by the Company

The Company has adopted all of the new, revised or amended Accounting Standards and Interpretations issued by the IASB that are mandatory for the current reporting period.

The adoption of these Accounting Standards and Interpretations did not have any significant impact on the financial performance or position of the Company.

 

c)

Changes in accounting policy

IFRS 15 Revenue from Contracts with Customers and IFRS 9 Financial Instruments (2014) became effective for periods beginning on or after January 1, 2018. Accordingly, the Company applied IFRS 15 and IFRS 9 for the interim period ended December 31, 2018. Changes to the Company’s accounting policies arising from these standards are summarized below:

IFRS 9 Financial Instruments

IFRS 9 Financial Instruments replaces IAS 39 Financial Instruments: Recognition and Measurement requirements. It makes major changes to the previous guidance on the classification and measurement of financial assets and introduces an ‘expected credit loss’ model for impairment of financial assets.

The adoption of this standard has no impact on the current or previous reporting period and as such there have been no adjustments to the opening balance of retained earnings.

IFRS 15 – Revenue from contracts with customers

Revenue is comprised mainly from funding from BARDA and from the sale of goods. To determine whether to recognize revenue, the Company follows a five-step process:

 

  1.

Identifying the contract with a customer,

 

F-10


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

c)

Changes in accounting policy (continued)

 

  2.

Identifying the performance obligations,

 

  3.

Determining the transaction price,

 

  4.

Allocating the transaction price to the performance obligation,

 

  5.

Recognizing revenue when performance obligation is satisfied.

Revenue from the sales of goods is recognized at a point in time, when the Company satisfies performance obligations by transferring the promised goods to its customers. The Company recognizes contract liabilities for consideration received in respect of unsatisfied performance obligations and reports these amounts as other liabilities in the statement of financial position. Similarly, if the Company satisfies a performance obligation before it receives the consideration, the Company recognizes either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due.

The adoption of this standard has no impact on the current or previous reporting period and as such there have been no adjustments to the opening balance of retained earnings.

Accounting Standards issued but not yet effective and not been adopted early by the Company

IFRS 16 Leases

IFRS 16:

 

   

replaces IAS 17 Leases and some lease-related Interpretations,

 

   

requires all leases to be accounted for ‘on-balance sheet’ by lessees, other than short-term and low value asset leases,

 

   

provides new guidance on the application of the definition of lease and on sale and lease back accounting,

 

   

largely retains the existing lessor accounting requirements in IAS 17,

 

   

requires new and different disclosures about leases.

Based on the entity’s assessment, it is expected that the first-time adoption of IFRS 16 for the year ending June 30, 2020 will have a material impact on the transactions and balances recognized in the financial statements, in particular:

 

   

lease assets and financial liabilities on the balance sheet will increase by A$1,108,610 and A$1,195,801 respectively (based on the facts at the date of the assessment),

 

   

there will be a reduction in the reported equity as the carrying amount of lease assets will reduce more quickly than the carrying amount of lease liabilities,

 

   

EBIT in the statement of profit or loss and other comprehensive income will be higher as the implicit interest in lease payments for former off-balance sheet leases will be presented as part of finance costs rather than being included in operating expenses,

 

F-11


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

c)

Changes in accounting policy (continued)

 

   

operating cash outflows will be lower and financing cash flows will be higher in the statement of cash flows as principal repayments on all lease liabilities will now be included in financing activities rather than operating activities. Interest can also be included within financing activities.

 

(d)

Basis of consolidation

The consolidated financial statements comprise the financial statements of Avita Medical Limited and its subsidiaries (‘the Company’) as at the reporting date each year. The Parent controls a subsidiary if it is exposed, or has rights, to variable returns from its involvement with the subsidiary and has the ability to affect those returns through its power over the subsidiary. All subsidiaries have a reporting date of June 30.

In preparing the consolidated financial statements, all intercompany balances and transactions, income and expenses and profit and losses resulting from intercompany transactions have been eliminated in full. Subsidiaries are fully consolidated from the date on which control is obtained by the Company and cease to be consolidated from the date on which control is transferred out of the Company.

 

(e)

Segment reporting

An operating segment is a component of an entity that engages in business activities from which it may earn revenues and incur expenses (including revenues and expenses relating to transactions with other components of the same entity), whose operating results are regularly reviewed by the entity’s chief operating decision maker to make decisions about resources to be allocated to the segment and assess its performance, and for which discrete financial information is available. This includes start-up operations which are yet to earn revenues. Management will also consider other factors in determining operating segments such as the existence of a line manager and the level of segment information presented to the Board of Directors.

Operating segments have been identified based on the information provided to the chief operating decision makers – being the Chief Executive Officer. The company aggregates two or more operating segments when they have similar economic characteristics, and the segments are similar in each of the following respects:

 

   

Nature of the products and services;

 

   

Nature of the production processes;

 

   

Type or class of customer for the products and services;

 

   

Methods used to distribute the products or provide the services; and if applicable

 

   

Nature of the regulatory environment.

Operating segments that meet the quantitative criteria as prescribed by IFRS 8 Operating Segments are reported separately. However, an operating segment that does not meet the quantitative criteria is still reported separately where information about the segment would be useful to users of the financial statements.

 

F-12


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(f)

Revenue recognition

Revenue is recognized and measured at the fair value of the consideration received or receivable to the extent it is probable that the economic benefits will flow to the Company and the revenue can be reliably measured. The following specific recognition criteria must also be met before revenue is recognized:

Sale of goods

Revenue from the sale of goods is recognized when the significant risks and rewards of ownership of the goods have passed to the buyer and the costs incurred or to be incurred in respect of the transaction can be measured reliably. Risks and rewards of ownership are considered passed to the buyer at the time of shipment of the goods to the customer.

BARDA income

The Company had been granted a BARDA contract in September 2015, wherein BARDA funded the Company to support the ongoing U.S. clinical regulatory program towards FDA Premarket Approval and Compassionate Use program, and clinical and health economics research in U.S. pediatric burn care. Barda income is recognized in the income statement when it is probable that the Company will receive the economic benefits of the contract and the amount can be reliably measured. The BARDA contract allows the Company to be reimbursed for costs incurred to fund the programs outlined above. The BARDA funds received are recognized in the period that the costs are incurred by the project.

Interest income

Revenue is recognized as interest accrues using the effective interest method.

 

(g)

Government and other grants

Government grants are recognized when there is reasonable assurance that the grant will be received, and all attaching conditions will be complied with.

When the grant relates to an expense item, it is recognized as income over the periods necessary to match the grant on a systematic basis to the costs that it is intended to compensate. Grants are not credited directly to shareholders equity.

When the grant relates to an asset, the fair value is credited to deferred income and is released to the profit or loss over the expected useful life of the relevant asset by equal annual instalments.

 

(h)

Leases

The determination of whether an arrangement is, or contains, a lease is based on the substance of the arrangement and requires an assessment of whether the fulfilment of the arrangement is dependent on the use of a specific asset or assets and the arrangement conveys a right to use the asset.

Company as a lessee

Finance leases, which transfer to the Company substantially all the risks and benefits incidental to ownership of the leased item, are capitalized at the inception of the lease at the fair value of the leased asset or, if lower, at the

 

F-13


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(h)

Leases (continued)

 

present value of the minimum lease payments. Lease payments are apportioned between the finance charges and reduction of the lease liability so as to achieve a constant rate of interest on the remaining balance of the liability. Finance charges are recognized as an expense in profit or loss.

Capitalized leased assets are depreciated over the shorter of the estimated useful life of the asset and the lease term if there is no reasonable certainty that the Company will obtain ownership by the end of the lease term.

Operating lease payments are recognized as an expense in profit or loss on a straight-line basis over the lease term. Operating lease incentives are recognized as a liability when received and subsequently reduced by allocating lease payments between rental expense and reduction of the liability.

 

(i)

Cash and cash equivalents

Cash and cash equivalents in the consolidated statement of financial position comprises of cash at bank and in hand and short-term deposits with an original maturity of three months or less that are readily convertible to known amounts of cash and which are subject to an insignificant risk of changes in value.

For the purposes of the consolidated statement of cash flows, cash and cash equivalents consist of cash and cash equivalents as defined above, net of outstanding bank overdrafts. Bank overdrafts are included within interest-bearing loans and borrowings in current liabilities on the consolidated statement of financial position.

 

(j)

Trade and other receivables

Trade receivables, which generally have 30- to 90-day terms, are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method, less an allowance for impairment.

Collectability of trade receivables is reviewed on an on-going basis at an operating unit level. Individual debts that are known to be uncollectible are written off when identified. An impairment provision is recognized when there is objective evidence that the Company will not be able to collect the receivable. Financial difficulties of the debtor, default payments and debts more than 90 days overdue may be considered objective evidence of impairment. The amount of the impairment loss is the receivable carrying amount compared to the present value of estimated future cash flows, discounted at the original effective interest rate.

 

(k)

Inventories

Inventories are valued at the lower of cost and net realizable value. Costs incurred in bringing each product to its present location and condition are accounted for at purchase cost on a first-in, first-out basis. Assembly costs as invoiced by a third party are factored into the cost of finished goods.

Net realizable value is the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs necessary to make the sale.

 

(l)

Foreign currency translation

Functional and presentational currency

Both the functional and presentational currency of Avita Medical Limited and its Australian subsidiaries is Australian dollars ($). The United Kingdom’s subsidiary’s functional currency is Pound Sterling and the United

 

F-14


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(l)

Foreign currency translation (continued)

 

States’ subsidiary’s functional currency is United States Dollars. These are translated to the presentational currency (see below).

Transactions and balances

Transactions in foreign currencies are initially recorded in the functional currency by applying the exchange rates ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies are retranslated at the rate of exchange ruling at the reporting date.

Non-monetary items that are measured in terms of historical cost in a foreign currency are translated using the exchange rate as at the date of the initial transaction. Non-monetary items measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined.

Translation of Company functional currency to presentational currency

The results of the overseas subsidiaries are translated into Australian Dollars as at the date of each transaction. Assets and liabilities are translated at exchange rates prevailing at reporting date. Profit and loss items are translated at average rates and equity items are translated at the date of each transaction. Exchange variations resulting from the translation are recognized in the foreign currency translation reserve in equity.

On consolidation, exchange differences arising from the translation of the net investment in overseas subsidiaries are taken to the foreign currency translation reserve. If an overseas subsidiary were sold, the proportionate share of exchange differences would be transferred out of equity and recognized in profit or loss.

 

(m)

Income tax and other taxes

Current tax assets and liabilities for the current and prior periods are measured at the amount expected to be recovered from or paid to the taxation authorities based on the current period’s taxable income. The tax rates and tax laws used to compute the amount are those that are enacted or substantively enacted by the reporting date. Included in income tax benefits are research and development claims.

Deferred income tax is provided on all temporary differences at the reporting date between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes.

Deferred income tax liabilities are recognized for all taxable temporary differences except:

 

   

when the deferred income tax liability arises from the initial recognition of goodwill or of an asset or liability in a transaction that is not a business combination and that, at the time of the transaction, affects neither the accounting profit nor taxable profit or loss; or

 

   

when the taxable temporary difference is associated with investments in subsidiaries, associates or interests in joint ventures, and the timing of the reversal of the temporary difference can be controlled and it is probable that the temporary difference will not reverse in the foreseeable future.

Deferred income tax assets are recognized for all deductible temporary differences, carry-forward of unused tax credits and unused tax losses, to the extent that it is probable that taxable profit will be available against which

 

F-15


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(m)

Income tax and other taxes (continued)

 

the deductible temporary differences and the carry-forward of unused tax credits and unused tax losses can be utilized, except:

 

   

when the deferred income tax asset relating to the deductible temporary difference arises from the initial recognition of an asset or liability in a transaction that is not a business combination and, at the time of the transaction, affects neither the accounting profit nor taxable profit or loss; or

 

   

when the deductible temporary difference is associated with investments in subsidiaries, associates or interests in joint ventures, in which case a deferred tax asset is only recognized to the extent that it is probable that the temporary difference will reverse in the foreseeable future and taxable profit will be available against which the temporary difference can be utilized.

The carrying amount of deferred income tax assets is reviewed at each reporting date and reduced to the extent that it is no longer probable that sufficient taxable profit will be available to allow all or part of the deferred income tax asset to be utilized.

Unrecognized deferred income tax assets are reassessed at each reporting date and are recognized to the extent that it has become probable that future taxable profit will allow the deferred tax asset to be recovered.

Deferred income tax assets and liabilities are measured at the tax rates that are expected to apply to the year when the asset is realized, or the liability is settled, based on tax rates (and tax laws) that have been enacted or substantively enacted at the reporting date.

Deferred tax assets and deferred tax liabilities are offset only if a legally enforceable right exists to set off current tax assets against current tax liabilities and the deferred tax assets and liabilities relate to the same taxable entity and the same taxation authority.

Tax consolidation legislation

Avita Medical Limited and its wholly-owned Australian controlled entities implemented the tax consolidation legislation as of July 1, 2003.

The parent entity, Avita Medical Limited, and the controlled entities in the tax consolidated Company continue to account for their own current and deferred tax amounts. The Company has applied the group allocation approach in determining the appropriate amount of current taxes and deferred taxes to allocate to members of the tax consolidated group.

In addition to its own current and deferred tax amounts, Avita Medical Limited also recognizes the current tax liabilities (or assets) and the deferred tax assets arising from unused tax losses and unused tax credits assumed from controlled entities in the tax consolidated group.

Assets or liabilities arising under tax funding agreements with the tax consolidated entities are recognized as amounts receivable from or payable to other entities in the Company.

Any difference between the amounts assumed and amounts receivable or payable under the tax funding agreement are recognized as a contribution to (or distribution from) wholly-owned tax consolidated entities.

 

F-16


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(m)

Income tax and other taxes (continued)

 

Other taxes

Revenues, expenses and assets are recognized net of the amount of Goods and Services Tax (GST) except:

 

   

when the GST incurred on a purchase of goods and services is not recoverable from the taxation authority, in which case the GST is recognized as part of the cost of acquisition of the asset or as part of the expense item as applicable; and

 

   

receivables and payables, which are stated with the amount of GST included.

The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables in the consolidated statement of financial position.

Cash flows are included in the consolidated statement of cash flows on a gross basis and the GST component of cash flows arising from investing and financing activities, which is recoverable from, or payable to, the taxation authority is classified as part of operating cash flows.

Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the taxation authority.

 

(n)

Plant and equipment

The Company’s fixed assets are stated at cost less accumulated depreciation and any accumulated impairment losses. Depreciation are computed based on the straight-line method over the estimated useful lives of the various classes of assets. The ranges of estimated useful lives for the principal classes of assets are as follows:

 

   

Laboratory equipment – 5 years

 

   

Computer equipment – 5 years

 

   

Fixtures and fittings – 7 years

The Company reviews its long-lived assets for impairment annually, or when events or changes in circumstances indicate that the carrying amounts of these assets may not be recoverable. An asset is considered impaired when the fair value, which is the expected undiscounted cash flows over the remaining useful life, is less than the net book value. The excess of the net book value over its fair value is charged as impairment loss to profit and loss account.

Repairs and maintenance are recognized in profit or loss during the financial period in which they are incurred. Gains and losses on disposal are determined by comparing the proceeds on disposal with the carrying amount and are included in profit or loss.

 

(o)

Trade and other payables

Trade payables and other payables are carried at amortized cost and due to their short-term nature, they are not discounted. They represent liabilities for goods and services provided to the Company prior to the end of the financial year that are unpaid and arise when the Company becomes obliged to make future payments in respect of the purchase of these goods and services. The amounts are unsecured and are usually paid within 30 days of recognition.

 

F-17


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(p)

Interest-bearing loans and borrowings

All loans and borrowings are initially recognized at the fair value of the consideration received less directly attributable transaction costs.

After initial recognition, interest-bearing loans and borrowings are subsequently measured at amortized cost using the effective interest method. Fees paid on the establishment of loan facilities that are yield related are included as part of the carrying amount of the loans and borrowings.

Borrowings are classified as current liabilities unless the Company has an unconditional right to defer settlement of the liability for at least 12 months after the reporting date.

Borrowing costs

Borrowing costs, other than borrowing costs relating to qualifying assets, are recognized as an expense when incurred.

 

(q)

Financial instruments

Recognition, initial measurement and derecognition

Financial assets and financial liabilities are recognized when the Company becomes a party to the contractual provisions of the financial instrument and are measured initially at fair value adjusted by transactions costs, except for those carried at fair value through profit or loss, which are measured initially at fair value. Subsequent measurement of financial assets and financial liabilities are described below.

Financial assets are derecognized when the contractual rights to the cash flows from the financial asset expire, or when the financial asset and all substantial risks and rewards are transferred. A financial liability is derecognized when it is extinguished, discharged, cancelled or expires.

Classification and subsequent measurement of financial assets

For the purpose of subsequent measurement, financial assets other than those designated and effective as hedging instruments are classified into the following categories upon initial recognition:

 

   

Loans and receivables;

 

   

Financial assets at Fair Value Through Profit or Loss (‘FVTPL’);

 

   

Held-To-Maturity (‘HTM’) investments; or

 

   

Available-For-Sale (‘AFS’) financial assets.

All financial assets except for those at FVTPL are subject to review for impairment at least at each reporting date to identify whether there is any objective evidence that a financial asset or a group of financial assets is impaired. Different criteria to determine impairment are applied for each category of financial assets, which are described below.

All income and expenses relating to financial assets that are recognized in the Statement of Profit or Loss and Other Comprehensive Income are presented within finance costs, finance income or other financial items, except for impairment of trade receivables which is presented within other expenses.

 

F-18


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(q)

Financial instruments (continued)

 

Loans and receivables

Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. After initial recognition, these are measured at amortized cost using the effective interest method, less provision for impairment. Discounting is omitted where the effect of discounting is immaterial. The Company’s cash and cash equivalents, trade and most other receivables fall into this category of financial instruments.

Individually significant receivables are considered for impairment when they are past due or when other objective evidence is received that a specific counterparty will default. Receivables that are not considered to be individually impaired are reviewed for impairment in groups, which are determined by reference to the industry and region of a counterparty and other shared credit risk characteristics. The impairment loss estimate is then based on recent historical counterparty default rates for each identified group.

AFS financial assets

AFS financial assets are non-derivative financial assets that are either designated to this category or do not qualify for inclusion in any of the other categories of financial assets.

All AFS financial assets are measured at fair value. Gains and losses are recognized in other comprehensive income and reported within the AFS reserve within equity, except for impairment losses and foreign exchange differences on monetary assets, which are recognized in profit or loss. When the asset is disposed of or is determined to be impaired the cumulative gain or loss recognized in other comprehensive income is reclassified from the equity reserve to profit or loss and presented as a reclassification adjustment within other comprehensive income. Interest calculated using the effective interest method and dividends are recognized in profit or loss within ‘finance income’.

Reversals of impairment losses for AFS debt securities are recognized in profit or loss if the reversal can be objectively related to an event occurring after the impairment loss was recognized. For AFS equity investments impairment reversals are not recognized in profit loss and any subsequent increase in fair value is recognized in other comprehensive income.

Classification and subsequent measurement of financial liabilities

The Company’s financial liabilities include borrowings, trade and other payables. Financial liabilities are measured subsequently at amortized cost using the effective interest method, except for financial liabilities held for trading or designated at FVTPL, that are carried subsequently at fair value with gains or losses recognized in profit or loss. All derivative financial instruments that are not designated and effective as hedging instruments are accounted for at FVTPL.

 

(r)

Provisions and employee leave benefits

Provisions are recognized when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation.

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(r)

Provisions and employee leave benefits (continued)

 

When the Company expects some or all of a provision to be reimbursed, for example under an insurance contract, the reimbursement is recognized as a separate asset but only when the reimbursement is virtually certain. The expense relating to any provision is presented in profit or loss net of any reimbursement.

Provisions are measured at the present value of management’s best estimate of the expenditure required to settle the present obligation at the reporting date using a discounted cash flow methodology. The risks specific to the provision are factored into the cash flows and as such a risk-free government bond rate relative to the expected life of the provision is used as a discount rate. If the effect of the time value of money is material, provisions are discounted using a current pre-tax rate that reflects the time value of money and the risks specific to the liability. The increase in the provision resulting from the passage of time is recognized in finance costs.

Employee leave benefits

Liabilities for wages and salaries, including non-monetary benefits, annual leave and accumulating sick leave expected to be settled within 12 months of the reporting date are recognized in respect of employees’ services up to the reporting date. They are measured at the amounts expected to be paid when the liabilities are settled. Expenses for non-accumulating sick leave are recognized when the leave is taken and are measured at the rates paid or payable.

 

(s)

Share-based payment transactions

The Company provides benefits to employees (including Key Management Personnel) in the form of share-based payments, whereby employees render services in exchange for shares or rights over shares (equity-settled transactions).

The Company has in place an Employee Share Option Plan (ESOP) which provides benefits to Senior Executives.

The cost of these equity-settled transactions with employees is measured by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by an external valuer using a binomial model.

The cost of equity-settled transactions is recognized, together with a corresponding increase in equity, over the period in which the performance and/or service conditions are fulfilled (the vesting period), ending on the date on which the relevant employees become fully entitled to the award (the vesting date).

At each subsequent reporting date until vesting, the cumulative charge to profit or loss is the product of:

 

  (i)

the grant date fair value of the award;

 

  (ii)

the current best estimate of the number of awards that will vest, taking into account such factors as the likelihood of employee turnover during the vesting period and the likelihood of non-market performance conditions being met; and

 

  (iii)

the expired portion of the vesting period.

The charge to profit or loss for the period is the cumulative amount as calculated above less the amounts already charged in previous periods. There is a corresponding entry to equity.

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(s)

Share-based payment transactions (continued)

 

The expense recognized by Avita Medical Limited in relation to equity-settled awards only represents the expense associated with grants to employees of the parent. The expense recognized by the Company is the total expense associated with all such awards.

Until an award has vested, any amounts recorded are contingent and will be adjusted if more or fewer awards vest than were originally anticipated to do so. Any award subject to a market condition is considered to vest irrespective of whether or not that market condition is fulfilled, provided that all other conditions are satisfied.

If the terms of an equity-settled award are modified, as a minimum an expense is recognized as if the terms had not been modified. An additional expense is recognized for any modification that increases the total fair value of the share-based payment arrangement, or is otherwise beneficial to the employee, as measured at the date of modification.

If an equity-settled award is cancelled, it is treated as if it had vested on the date of cancellation, and any expense not yet recognized for the award is recognized immediately. However, if a new award is substituted for the cancelled award and designated as a replacement award on the date that it is granted, the cancelled and new award are treated as if they were a modification of the original award, as described in the previous paragraph.

The dilutive effect, if any, of outstanding options is reflected as additional share dilution in the computation of diluted earnings per share.

 

(t)

Contributed equity

Ordinary shares are classified as equity. Incremental costs directly attributable to the issue of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.

Basic loss per share is calculated as net loss attributable to members of the parent, adjusted to exclude any costs of servicing equity (other than dividends), divided by the weighted average number of ordinary shares.

Diluted loss per share is calculated as net loss attributable to members of the parent, adjusted for:

 

   

costs of servicing equity (other than dividends);

 

   

the after-tax effect of dividends and interest associated with dilutive potential ordinary shares that have been recognized as expenses; and

 

   

other non-discretionary changes in revenues or expenses during the year that would result from the dilution of potential ordinary shares;

 

   

divided by the weighted average number of ordinary shares and dilutive potential ordinary shares, adjusted for any bonus element.

 

(u)

Research and development costs

Expenditures during the research phase of a project are recognized as expenses when incurred. Development costs are capitalized only when technical feasibility studies identify that the project is expected to deliver future economic benefits and these benefits can be measured reliably.

 

F-21


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(u)

Research and development costs (continued)

 

Capitalized development costs have a finite useful life and amortized on a systematic basis based on the future economic benefits over the useful life of the project.

 

(v)

Going concern

These financial statements have been prepared on the basis of going concern, which contemplates the continuity of normal business activities and the realization of assets and settlement of liabilities in the ordinary course of business. During the financial year ended June 30, 2018, the Company has generated a loss for the period of A$16,519,155 (2017: A$11,511,024 and 2016: A$7,778,015) and the Company has used cash in operations of A$16,372,024 (2017: A$8,557,524 and 2016: A$7,938,557).

During the year ended June 30, 2018 and subsequent to year end, the Company completed a series of equity transactions totaling gross proceeds of A$74,775,545 which were used to fund operations. Of the total gross proceeds, A$29,760,645 was received in transactions completed during the year ended June 30, 2018, and A$45,014,900 was received in transactions completely subsequent to June 30, 2018.

On October 11, 2017 the Company completed a placement of 100,982,978 fully paid ordinary shares at a price of A$0.045 per share raising gross proceeds of A$4,544,234. On November 7, 2017 the Company completed a rights offering of 276,502,853 fully paid ordinary shares at a price of A$0.045 per share raising gross proceeds of A$12,442,628. On June 6, 2018 the Company completed the first tranche of an institutional placement in which it issued 255,475,665 fully paid ordinary shares at a price of A$0.050 per share raising gross proceeds of A$12,773,783. The institutional placement included a second tranche totaling A$3.250 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the Company issued 65 million shares at a price of A$0.050 per share and received gross proceeds of A$3,250,000 on July 26, 2018.

Also subsequent to year end, on December 4, 2018 the Company completed the first tranche of an institutional placement of in which it issued 310,047,015 fully paid ordinary shares at a price of A$0.080 per share raising gross proceeds of A$24,803,761. The institutional placement included a second tranche totaling A$15.196 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on January 14, 2019, and the Company issued 189,952,985 shares at a price of A$0.080 per share and received gross proceeds of A$15,196,239 on January 14, 2019. In addition, on January 11, 2010 the Company complete a Share Purchase Plan under which it issued 22,061,250 shares of stock at a price of A$0.080 per share and received gross proceeds of A$1,764,900.

The Company also benefits from cash inflows from the series of BARDA contracts, the first of which was awarded to the Company in September 2015. These payments from BARDA offset the costs from various activities undertaken to support the FDA regulatory approval process for RECELL in the U.S., preparation for the planned commercial launch of RECELL in the U.S., and other RECELL clinical programs in the U.S. Another anticipated source of capital for the Company is the potential triggering of the BARDA contract covering the initial purchase, storage and delivery of RECELL devices in the amount of US$7,594,620 (~A$10.2m).

The Company expects to be utilizing cash reserves until U.S. and international sales of its products reach the level to fund ongoing operations. The Company has historically funded its research and development activities

 

F-22


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

2.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)

 

(v)

Going concern (continued)

 

through raising capital by issuing securities in the Company, and it is expected that similar funding will be obtained to provide working capital as and when required. If the Company is unable to raise capital in the future, the Company may need to curtail expenditures by scaling back certain research and development or other programs.

As a result of the above, the directors are satisfied that there is sufficient working capital to support the committed research development programs and other activities over the next 12 months and the Company has the ability to realize its assets and pay its liabilities and commitments in the normal course of business. Accordingly, the directors have prepared the financial report on a going concern basis.

 

3.

SIGNIFICANT ACCOUNTING JUDGEMENTS, ESTIMATES AND ASSUMPTIONS

The preparation of the financial statements requires management to make judgements, estimates and assumptions that affect the reported amounts in the financial statements. Management continually evaluates its judgements and estimates in relation to assets, liabilities, contingent liabilities, revenue and expenses. Management bases its judgements and estimates on historical experience and on other various factors it believes to be reasonable under the circumstances, the result of which form the basis of the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.

Management has identified the following critical accounting policies for which significant judgements, estimates and assumptions are made. Actual results may differ from these estimates under different assumptions and conditions and may materially affect financial results or the financial position reported in future periods.

 

(a)

Significant accounting estimates and assumptions

Share-based payment transactions

The Company measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using a binomial model, using the assumptions detailed in note 18 (g).

The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next annual reporting period but may impact expenses and equity.

 

(b)

Significant accounting judgments

Estimation of useful lives of assets

The estimation of the useful lives of assets has been based on historical experience. In addition, the condition of the assets is assessed at least once per year and considered against the remaining useful life. Adjustments to useful lives are made when considered necessary. Depreciation charges are included in note 4(d).

Impairment of non-financial assets other than goodwill

The Company assesses impairment of all assets at each reporting date by evaluating conditions specific to the Company and to the particular asset that may lead to impairment. These include product and manufacturing

 

F-23


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

3.

SIGNIFICANT ACCOUNTING JUDGEMENTS, ESTIMATES AND ASSUMPTIONS (CONTINUED)

 

(b)

Significant accounting judgments (continued)

 

performance, technology, economic and political environments and future product expectations. If an impairment trigger exists, the recoverable amount of the asset is determined. This involves value in use calculations, which incorporate a number of key estimates and assumptions.

Taxation

The Company’s accounting policy for taxation requires management’s judgement as to the types of arrangements considered to be a tax on income in contrast to an operating cost. Judgement is also required in assessing whether deferred tax assets and certain deferred tax liabilities are recognized on the consolidated statement of financial position. Deferred tax assets, including those arising from unrecouped tax losses, capital losses and temporary differences, are recognized only where it is considered more likely than not that they will be recovered, which is dependent on the generation of sufficient future taxable profits.

Assumptions about the generation of future taxable profits depend on management’s estimates of future cash flows. These depend on estimates of future production and sales volumes, operating costs, capital expenditure, dividends and other capital management transactions. Judgements are also required about the application of income tax legislation. These judgements and assumptions are subject to risk and uncertainty, hence there is a possibility that changes in circumstances will alter expectations, which may impact the amount of deferred tax assets and deferred tax liabilities recognized on the consolidated statement of financial position and the amount of other tax losses and temporary differences not yet recognized. In such circumstances, some or all of the carrying amounts of recognized deferred tax assets and liabilities may require adjustment, resulting in a corresponding credit or charge to profit or loss.

 

4.

REVENUES AND EXPENSES

 

          Year Ended June 30,  
          2018      2017      2016  

(a)

  

Revenue

        
   Sale of goods    A$ 1,198,861      A$ 901,376      A$ 1,002,007  
     

 

 

    

 

 

    

 

 

 
   Total revenue    A$ 1,198,861      A$ 901,376      A$ 1,002,007  
     

 

 

    

 

 

    

 

 

 

The Company had been granted a BARDA contract in September 2015, wherein BARDA will fund the Company to support the ongoing U.S. clinical regulatory program towards FDA Premarket Approval and Compassionate Use program, and clinical and health economics research in U.S. pediatric burn care. The objectives support BARDA’s overarching goal of building burn care preparedness, by securing effective medical countermeasures for burn injuries for use in case of a mass casualty.

 

          Year Ended June 30,  
          2018      2017      2016  

(b)

   Other income         
  

BARDA income

   A$ 10,104,081      A$ 6,886,236      A$ 2,424,357  
  

Other income

     68,617        344,734        120,160  
     

 

 

    

 

 

    

 

 

 
  

Total other income

   A$ 10,172,698      A$ 7,230,970      A$ 2,544,517  
     

 

 

    

 

 

    

 

 

 

 

F-24


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

4.

REVENUES AND EXPENSES (CONTINUED)

 

          Year Ended June 30,  
          2018      2017      2016  

(c)

  

Finance costs

        
   Other loans    A$ 26,586      A$ 12,754      A$ 21  
     

 

 

    

 

 

    

 

 

 
      A$ 26,586      A$ 12,754      A$ 21  
     

 

 

    

 

 

    

 

 

 

 

          Year Ended June 30,  
          2018      2017     2016  

(d)

  

Depreciation, impairment and amortization included

in profit or loss

       
  

Depreciation

   A$ 143,546      A$ 139,703     A$ 83,724  
  

(Profit)/Loss on disposal of plant and equipment

     —          (1,347     440  
     

 

 

    

 

 

   

 

 

 
      A$ 143,546      A$ 138,356     A$ 84,164  
     

 

 

    

 

 

   

 

 

 

 

          Year Ended June 30,  
          2018      2017      2016  

(e)

  

Cost of sales

   A$ 511,646      A$ 463,285      A$ 401,568  
     

 

 

    

 

 

    

 

 

 

 

          Year Ended June 30,  
          2018      2017      2016  

(f)

  

Lease payments and other expenses included in profit or loss

   A$ 463,095      A$ 418,193      A$ 283,412  
     

 

 

    

 

 

    

 

 

 

 

          Year Ended June 30,  
          2018      2017      2016  

(g)

   Employee benefits expense         
   Salaries and wages    A$ 8,057,869      A$ 6,143,458      A$ 4,669,718  
   Share-based expenses      1,835,157        1,587,243        956,658  
   Defined contribution superannuation expense      374,435        341,586        311,435  
     

 

 

    

 

 

    

 

 

 
      A$ 10,267,461      A$ 8,072,287      A$ 5,937,811  
     

 

 

    

 

 

    

 

 

 

 

5.

LOSS PER SHARE

Basic loss per share amounts are calculated by dividing the net loss for the year by the weighted average number of ordinary shares outstanding during the year.

Diluted earnings per share amounts are calculated by dividing the net loss for the year by the weighted average number of ordinary shares outstanding during the year plus the weighted average number of ordinary shares that would be issued on the conversion of all the dilutive potential ordinary shares into ordinary shares.

The following reflects the income and share data used in the basic and diluted loss per share computations:

 

     Year Ended June 30,  
     2018     2017     2016  

Net loss for the period

   A$ (16,519,155   A$ (11,511,024   A$ (7,778,015
  

 

 

   

 

 

   

 

 

 

Weighted average number of ordinary shares for basic and diluted loss per share

     934,312,458       669,930,538       498,786,987  
  

 

 

   

 

 

   

 

 

 

 

F-25


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

5.

LOSS PER SHARE (CONTINUED)

 

Transactions involving ordinary shares or potential ordinary shares that would change the number of ordinary shares or potential ordinary shares outstanding between the reporting date and the date of the completion of these financial statements are disclosed in Note 25 to the consolidated financial statements.

A total of 29,131,664 options (2017: 24,797,286 and 2016: 11,147,289) were not included in the dilutive loss per share calculation as they are anti-dilutive.

 

6.

INCOME TAX

 

     Year Ended June 30  
     2018     2017     2016  

(a)   Income tax expense

      

The major components of income tax benefit are:

      

Current income tax benefit:

      

Current income tax benefit – R&D Claim

   A$ (1,420,752   A$ (1,048,634   A$ (971,881

Adjustment for prior year tax

     34,956       —         —    
  

 

 

   

 

 

   

 

 

 

Income tax benefit reported in profit or loss – R&D Claim

   A$ (1,385,796   A$ (1,048,634   A$ (971,881
  

 

 

   

 

 

   

 

 

 

(b)  Numerical reconciliation of income tax expense to prima facie tax payable

      

Loss from continuing operations before income tax expense

   A$ (17,904,569   A$ (12,559,261   A$ (11,243,843

Profit for the period from discontinued operations

     —         —         2,493,947  
  

 

 

   

 

 

   

 

 

 
     (17,904,569     (12,559,261     (8,749,896
  

 

 

   

 

 

   

 

 

 

Tax at the Australian rate of 27.5% (2017: 27.5% and 2016: 30%)

   $ (4,923,756   $ (3,767,778   $ (2,624,969

Tax effect of amounts which are not deductible/(taxable) in calculating taxable income:

      

Other

     1,464,746       792,798       921,793  

Tax losses not brought to account

     3,537,629       2,974,980       1,703,176  

Research and development tax offset

     (1,420,751     (1,048,634     (971,881

Adjustment for prior year research and development tax offset

     34,955       —         —    

Adjustment due to change in tax rate

     66,341       —         —    
  

 

 

   

 

 

   

 

 

 
     (1,240,836     (1,048,634     (971,881
  

 

 

   

 

 

   

 

 

 

Movement in deferred tax asset

     —         41,629       451,777  

Deferred tax assets not brought to account as realization is not considered probable

     (144,960     (41,629     (451,777
  

 

 

   

 

 

   

 

 

 

Income tax benefit

   A$ (1,385,796   A$ (1,048,634   A$ (971,881
  

 

 

   

 

 

   

 

 

 

 

F-26


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

6.

INCOME TAX (CONTINUED)

 

     As of June 30,  
     2018     2017     2016  

(c)   Non-current assets – Deferred tax assets

      

The balance comprises temporary differences attributable to:

      

Provisions

   A$ 122,243     A$ 48,513     A$ 82,074  

Property, plant and equipment

     10,155       12,945       13,905  

Intangible assets

     1,025,616       735,400       611,343  

Other

     2,378       (766     —    
  

 

 

   

 

 

   

 

 

 

Total deferred tax assets

     1,160,392       796,092       707,322  
  

 

 

   

 

 

   

 

 

 

Set off deferred tax liabilities pursuant to set-off provisions

     —         —         —    
  

 

 

   

 

 

   

 

 

 
     1,160,392       796,092       707,322  
  

 

 

   

 

 

   

 

 

 

Deferred tax assets not brought to account as realization is not considered probable

     (1,160,392     (796,092     (707,322
  

 

 

   

 

 

   

 

 

 

Deferred tax assets recognized

   A$ —       A$ —       A$ —    
  

 

 

   

 

 

   

 

 

 

 

Movements – Consolidated    Provisions     Plant and
equipment
    Intangible
assets
    Other     Total  

At June 30, 2015

   A$ 56,525     A$ 15,713     A$ 963,007     A$ (1,164   A$ 1,034,081  

(Charged) / credited to the consolidated statement of profit or loss and other comprehensive income

     25,459       (1,808     (351,664     1,164       (326,849
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At June 30, 2016

     81,984       13,905       611,343       —         707,232  

(Charged) / credited to the consolidated statement of profit or loss and other comprehensive income

     (33,561     (960     124,057       (766     88,770  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At June 30, 2017

     48,423       12,945       735,400       (766     796,002  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

(Charged) / credited to the consolidated statement of profit or loss and other comprehensive income

     73,730       (2,790     (219,044     3,144       (144,960

(Charged) / credited directly to equity

     —         —         509,260       —         509,260  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

At June 30, 2018

   A$ 122,153     A$ 10,155     A$ 1,025,616     A$ 2,378     A$ 1,160,302  
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

F-27


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

6.

INCOME TAX (CONTINUED)

 

Tax losses

The Company has income tax losses for which no deferred tax asset is recognized on the consolidated statement of financial position of A$111,722,828 (2017: A$100,140,383 and 2016: A$89,534,487) which are available indefinitely for offset against future taxable profits subject to continuing to meet relevant statutory tests. The total losses of the Company are broken down in the following table:

 

Jurisdiction

   Total Losses      Relevant Tax
Rate
    Relevant Tax  

Australia

   A$ 42,786,807        27.50   A$ 11,766,372  

United States

     28,875,605        21.00     6,063,877  

United Kingdom

     40,060,416        19.00     7,611,479  
  

 

 

      

 

 

 

Total

   A$ 111,722,828        A$ 25,441,728  
  

 

 

      

 

 

 

Unrecognized temporary differences

At June 30, 2018, there is no recognized or unrecognized deferred income tax liability (2017 and 2016: A$nil) for taxes that would be payable on the unremitted earnings of certain of the Company’s subsidiaries. The Company has no liability for additional taxation should unremitted earnings be remitted (2017 and 2016: A$nil).

Tax consolidation

 

(i)

Members of the tax consolidated group and the tax sharing arrangement

Avita Medical Limited and its 100% owned Australian resident subsidiaries formed a tax consolidated group with effect from July 1, 2003. Avita Medical Limited is the parent entity of the tax consolidated group. Members of the group have not entered into a tax sharing arrangement or a tax funding arrangement.

 

(ii)

Tax effect accounting by members of the tax consolidated group

No amounts have been recognized as tax consolidation contribution adjustments in preparing the accounts of Avita Medical Limited.

 

7.

CURRENT ASSETS – CASH AND CASH EQUIVALENTS

 

     As of June 30,  
     2018      2017  

Cash at bank and in hand

   A$ 14,825,532      A$ 3,790,491  

Short term deposits

     —          —    
  

 

 

    

 

 

 
   A$ 14,825,532      A$ 3,790,491  
  

 

 

    

 

 

 

 

F-28


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

8.

CURRENT ASSETS – TRADE AND OTHER RECEIVABLES

 

     As of June 30,  
     2018      2017  

Trade receivables

   A$ 263,421      A$ 259,012  

Allowance for doubtful debts

     (23,452      (88,859
  

 

 

    

 

 

 
     239,969        170,153  

R&D Tax claim

     2,434,430        1,048,634  

BARDA and other receivables

     2,762,958        851,747  
  

 

 

    

 

 

 

Carrying amount of trade and other receivables

   A$ 5,437,357      A$ 2,070,534  
  

 

 

    

 

 

 

 

(a)

Allowance for impairment loss

Trade receivables are non-interest bearing and are generally on 30 to 90-day terms. An allowance for impairment loss is made when there is objective evidence that the Company will not be able to collect the debts. Bad debts are written off when identified. Financial difficulties of the debtor, default payments or debts more than 90 days overdue are considered objective evidence of impairment. The amount of the impairment loss is the receivable carrying amount compared to the present value of estimated future cash flows, discounted at the original effective interest rate.

A gain of A$nil (2017: A$nil) has been recognized by the Company in the current year on recovery of these previously impaired receivables.

Movements in the allowance for impairment loss were as follows:

 

     As of June 30,  
     2018      2017  

At July 1

   A$ 88,859      A$ —    

Received during the year

     —          —    

Write off during the year

     (88,859      —    

Charge for the year

     23,452        88,859  
  

 

 

    

 

 

 

At June 30

   A$ 23,452      A$ 88,859  
  

 

 

    

 

 

 

At June 30, the aging analysis of trade receivables is as follows:

 

            Total     

0-30

days

    

31-60

days

    

61-90

days

    

+91

days

PDNI*

    

+91

days

CI**

 

2018

     Consolidated        263,421        129,979        82,406        6,173        42,792        2,071  

2017

     Consolidated        259,012        95,180        32,866        40,374        1,733        88,859  

 

*

Past due not impaired (“PDNI”)

**

Considered impaired (“CI”)

The Company’s trade receivables past due but not considered impaired amounted to A$23,452 at June 30, 2018 (2017: A$nil). Payment terms on these amounts have not been re-negotiated however each operating unit has been in direct contact with the relevant debtor and is satisfied that payment will be received in full.

 

F-29


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

8.

CURRENT ASSETS – TRADE AND OTHER RECEIVABLES (CONTINUED)

 

(a)

Allowance for impairment loss (continued)

 

Other balances within trade and other receivables which have similar terms as trade receivables do not contain impaired assets and are not past due. It is expected that these other balances will be received when due.

 

(b)

Fair value and credit risk

Due to the short-term nature of these receivables, their carrying value is assumed to approximate their fair value. The maximum exposure to credit risk is the fair value of receivables. Collateral is not held as security, nor is it the Company’s policy to transfer (on-sell) receivables to special purpose entities.

 

(c)

Foreign exchange and interest rate risk

Detail regarding foreign exchange and interest rate risk exposure is disclosed in Note 20.

 

9.

CURRENT ASSETS – INVENTORIES

 

     As of June 30,  
     2018      2017  

Raw materials and components at cost

   A$ 778,947      A$ 804,052  

Finished goods at cost

     376,879        233,438  
  

 

 

    

 

 

 

Total inventories at cost

   A$ 1,155,826      A$ 1,037,490  
  

 

 

    

 

 

 

A provision of A$42,412 (2017: A$1,660 and 2016: A$1,766) has been allocated against raw materials to reduce the carrying amount of certain inventory items to nil net realizable value. The change in provision of inventory has been included in the cost of sales line item as a cost of inventories in the consolidated statement of profit or loss and other comprehensive income.

Inventory expense

Inventories recognized as an expense as a result of expiration for the year ended June 30, 2018 totaled A$38,107 (2017: A$408,052 and 2016: A$182,150).

 

F-30


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

10.

NON-CURRENT ASSETS – PLANT AND EQUIPMENT

Reconciliation of carrying amounts at the beginning and end of the period

 

     Plant and
Equipment
 

Year ended June 30, 2018

  

At July 1, 2017, net of accumulated depreciation

   A$ 387,380  

Additions

     498,749  

Depreciation charge for the year

     (143,546
  

 

 

 

As of June 30, 2018, net of accumulated depreciation

   A$ 742,583  
  

 

 

 

As of June 30, 2018

  

Cost

   A$ 1,448,142  

Accumulated depreciation

     (705,559
  

 

 

 

Net carrying amount

   A$ 742,583  
  

 

 

 

 

     Plant and
Equipment
 

Year ended June 30, 2017

  

At July 1, 2016, net of accumulated depreciation

   A$ 94,491  

Additions

     432,592  

Depreciation charge for the year

     (139,703
  

 

 

 

As of June 30, 2017, net of accumulated depreciation

   A$ 387,380  
  

 

 

 

As of June 30, 2017

  

Cost

   A$ 1,307,367  

Accumulated depreciation

     (919,987
  

 

 

 

Net carrying amount

   A$ 387,380  
  

 

 

 

 

11.

CURRENT LIABILITIES – TRADE AND OTHER PAYABLES

 

     As of June 30,  
     2018      2017  

Trade payables

   A$ 271,913      A$ 990,040  

Accruals and other payables

     3,215,669        1,373,694  
  

 

 

    

 

 

 

Carrying amount of trade and other payables

   A$ 3,487,582      A$ 2,363,734  
  

 

 

    

 

 

 

 

(a)

Fair value

Due to the short-term nature of these payables, their carrying value is assumed to approximate their fair value.

 

(b)

Interest rate, foreign exchange and liquidity risk

Information regarding interest rate, foreign exchange and liquidity risk exposure is set out in Note 20.

 

F-31


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

12.

CURRENT LIABILITIES – PROVISIONS

 

     As of June 30,  
     2018      2017  

Provision for annual leave (i)

   A$ 376,535      A$ 136,822  

Provision for long service leave (ii)

     19,000        45,533  
  

 

 

    

 

 

 
   A$ 395,535      A$ 182,355  
  

 

 

    

 

 

 

Employee benefits

 

  (i)

A provision is recognized for annual leave due to employees at the end of the year.

 

  (ii)

A provision is recognized for long service leave due to employees at the end of the year.

 

13.

CONTRIBUTED EQUITY

 

     As of June 30,  
     2018      2017  

Ordinary shares

     

Authorized, issued and fully paid

     162,801,028        134,806,022  
  

 

 

    

 

 

 

Fully paid ordinary shares carry one vote per share and carry the right to dividends.

 

Movement in ordinary shares on issue    Number      A$  

At July 1, 2016

     532,751,995        126,264,372  

New shares

     139,467,859        9,048,102  

Capital issue costs

     —          (506,452
  

 

 

    

 

 

 

At July 1, 2017

     673,219,854        134,806,022  

New shares

     633,658,471        29,846,859  

Cancelled shares

     (29,500,000      —    

Capital issue costs

     —          (1,851,853
  

 

 

    

 

 

 

At June 30, 2018

     1,277,378,325        162,801,028  
  

 

 

    

 

 

 

Capital management

When managing capital, management’s objective is to ensure the entity continues as a going concern as well as to maintain optimal returns to shareholders and benefits for other stakeholders. Management also aims to maintain a capital structure that ensures the lowest cost of capital available to the entity. The Company regularly reviews the capital structure and seeks to take advantage of available opportunities to improve outcomes for the Company and its shareholders.

For the year ended 30 June 2018, there were no dividends paid and management has no plans to commence the payment of dividends. Management has no current plans to issue further shares on the market but will continue to assess market conditions and the company’s cash flow requirements to ensure the company is appropriately funded.

The Company monitors capital on the basis of the gearing ratio, however there is no significant external borrowing at the reporting date. Neither the Company nor any of the subsidiaries are subject to externally imposed capital requirement.

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

14.

ACCUMULATED LOSSES AND RESERVES

 

(a)

Movements in accumulated losses were as follows:

 

     As of June 30,  
     2018      2017  

Balance July 1

   A$ (132,218,352    A$ (121,108,408

Net loss attributable to owners of Avita Medical Limited

     (16,519,155      (11,511,024

Transfer from expired / lapsed options

     141,188        401,080  

Cancelled options

     3,440        —    
  

 

 

    

 

 

 

Balance June 30

   A$ (148,592,879    A$ (132,218,352
  

 

 

    

 

 

 

 

(b)

Nature and purpose of reserves

Employee equity benefits reserve

The employee equity benefits reserve is used to record the value of share-based payments provided to employees, including Key Management Personnel, as part of their remuneration. Refer to note 17 for further details of these plans.

Foreign currency translation reserve

The foreign currency translation reserve is used to record exchange differences arising from the translation of the financial statements of foreign subsidiaries.

Available for sales reserve

Available for sale reserve is used to record the gain from measuring financial assets at fair value.

 

F-33


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

15.

CONSOLIDATED STATEMENT OF CASH FLOWS RECONCILIATION

 

     June 30,  
     2018     2017     2016  

Reconciliation of net loss after tax to net cash flows from operations

      

Loss from ordinary activities after tax

   A$ (16,519,155   A$ (11,511,024   A$ (7,778,015

Adjustments for non-cash items:

      

Depreciation

     143,546       139,703       83,724  

Share options expensed

     1,835,157       1,587,243       956,658  

Share options cancelled classified as financing activities

     62,681      

R&D claim accrual

     (1,385,414    

Foreign exchange differences

     592,385       —         —    

Investment

     —         —         (453,892

Loss on disposal of PPE

     —         —         3,124  

Changes in assets and liabilities:

      

(Increase)/decrease in inventories

     (118,336     333,132       (776,105

Increase in trade and other receivables

     (1,980,566     (49,040     (516,052

(Increase) / decrease in prepayments

     (473,690     (156,756     17,892  

Increase in trade and other payables

     1,258,186       1,125,116       494,561  

Increase/(decrease) in provisions

     213,182       (25,898     29,549  
  

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

   A$ (16,372,024   A$ (8,557,524   A$ (7,938,557
  

 

 

   

 

 

   

 

 

 

 

16.

RELATED PARTY DISCLOSURE

 

(a)

Subsidiaries

The consolidated financial statements include the financial statements of Avita Medical Limited and the subsidiaries listed in the following table:

 

Name   

Country of

Incorporation

    

% Equity
interest
 at

June 30,
2018

   

% Equity
interest
 at

June 30,
2017

   

% Equity
interest
 at

June 30,
2016

   

Investment ($)

at June 30, 2018

    

Investment ($)

at June 30, 2017

 

C3 Operations Pty Ltd

     Australia        100%       100%       100%     A$ —        A$ —    

Avita Medical Europe Ltd

    
United
Kingdom
 
 
     100%       100%       100%       —          —    

Avita Medical Americas LLC

    
United
States
 
 
     100%       100%       100%       —          —    

Infamed Pty Limited

     Australia        100%       100%       100%       —          —    

Visiomed Group Pty Ltd

     Australia        100%       100%       100%       4,643,888        4,643,888  
           

 

 

    

 

 

 
            A$ 4,643,888      A$ 4,643,888  
           

 

 

    

 

 

 

 

(b)

Ultimate parent

Avita Medical Limited is the ultimate parent entity in the wholly-owned company.

 

F-34


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

16.

RELATED PARTY DISCLOSURE (CONTINUED)

 

(c)

Key Management Personnel

The total remuneration paid to key management personnel of the Company during year is detailed below.

 

     Year ended June 30,  
     2018      2017      2016  

Short-term employee benefits

   A$ 3,770,141      A$ 2,933,510      A$ 1,904,993  

Post-employment employee benefits

     90,512        112,034        108,486  

Share-based expenses

     1,596,368        1,215,809        902,959  
  

 

 

    

 

 

    

 

 

 

Total compensation

   A$ 5,457,021      A$ 4,261,353      A$ 2,916,438  
  

 

 

    

 

 

    

 

 

 

Refer to the remuneration report contained the Directors’ Report for details of the remuneration paid or payable to each member of the Company’s key management personnel for the year ended June 30, 2018.

The total amount of transactions entered into with Key Management Personnel for the year ended June 30, 2018 were A$157,728 Consultancy fees (2017: A$128,987 and 2016: A$59,675) paid under normal terms and conditions to Bioscience Managers Pty Ltd of which Mr. Curnock Cook is an officer and Dr. Michael Perry is a director.

 

(d)

Transactions with related parties

Subsidiaries of the Company

During the reporting period, inter-company other revenue was made of A$2,819,592 (2017: A$2,087,051 and 2016: A$1,995,041) by Avita Medical Europe Ltd and Avita Medical Americas LLC to Avita Medical Limited. These have been eliminated on consolidation.

Employees

Contributions to superannuation funds on behalf of employees are disclosed in note 4(g).

Terms and conditions of transactions with related parties

Outstanding balances at year end are unsecured, interest free and settlement occurs in cash.

 

17.

SHARE-BASED PAYMENT PLANS

 

(a)

Recognized share-based payment expenses

The expense recognized for employee services received during the year is shown in the table below:

 

     Year ended June 30,  
     2018      2017      2016  

Expenses arising from equity-settled share-based payment transactions

   A$ 1,835,157      A$ 1,587,243      A$ 956,658  
  

 

 

    

 

 

    

 

 

 

Total expense arising from share-based payment transactions

   A$ 1,835,157      A$ 1,587,243      A$ 956,648  
  

 

 

    

 

 

    

 

 

 

 

F-35


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

17.

SHARE-BASED PAYMENT PLANS (CONTINUED)

 

(a)

Recognized share-based payment expenses (continued)

 

The share-based payment plans are described below. There have been share-based plan forfeitures during fiscal 2018 and 2017.

 

(b)

Types of share-based payment plans

Employee Share Option Plan (ESOP)

Share options are granted to Senior Executives and employees under the Employee Share Option Plan at the discretion of the Board. The exercise price of the options is based on a weighted average market price of the shares preceding the date of grant. The options vest at the time of grant and the contractual life of each option granted is ten years. There are no cash settlement alternatives.

Subject to shareholder approval, options may also be granted to Directors at the discretion of the Board. The exercise price of the options is based on a weighted average market price of the shares preceding the date of grant. The options vest either at the time of grant or are subject to performance conditions at the discretion of the Board and the contractual life of each option granted is three years. There are no cash settlement alternatives.

 

(c)

Summaries of options granted under ESOP arrangements

The following table illustrates the number (No) and weighted average exercise price (WAEP) of, and movements in, share options issued during the year:

 

     2018
No
    2018
WAEP
     2017
No
    2017
WAEP
     2016
No
    2016
WAEP
 

Outstanding at the beginning of the year

     24,797,286     A$ 0.09        11,147,289     A$ 0.14        9,441,250     A$ 0.14  

Expired during the year

     (3,937,289     0.13        (4,710,000     0.14        (1,450,000     0.14  

Forfeiture

     (838,333     0.08        (2,500,000     0.15        —         —    

Granted during the year

     9,110,000       0.06        20,859,997       0.08        3,156,039       0.16  
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

Outstanding at the end of the year

     29,131,664     A$ 0.078        24,797,286     A$ 0.084        11,147,289     A$ 0.149  
  

 

 

   

 

 

    

 

 

   

 

 

    

 

 

   

 

 

 

As at the reporting date, there were 29,131,664 unissued ordinary shares under options represented by:

1,110,000 exercisable at A$0.08 expiring December 31, 2018 issued to an employee on July 1, 2017.

17,910,415 exercisable at A$0.085 expiring May 18, 2027 issued to employees on May 18, 2017.

1,072,916 exercisable at A$0.082 expiring May 26, 2027 issued to an employee on May 26, 2017.

1,038,333 exercisable at A$0.08 expiring June 27, 2027 issued to employees on June 27, 2017.

4,000,000 exercisable at A$0.063 expiring September 6, 2027 issued to an employee on September 6, 2017.

4,000,000 exercisable at A$0.061 expiring January 3, 2028 issued to an employee on January 3, 2018.

Option holders do not have any right, by virtue of the option, to participate in any share issue of the Company or any related corporate body.

 

F-36


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

17.

SHARE-BASED PAYMENT PLANS (CONTINUED)

 

(c)

Summaries of options granted under ESOP arrangements (continued)

 

Shares issued as a result of the exercise of options

During the financial year and up to the date of this report, no options were exercised to acquire fully paid ordinary shares in the Company.

 

(d)

Weighted average remaining contractual life

The weighted average remaining contractual life for the share options outstanding as at June 30, 2018 is 9.52 years (2017: 9.39 years and 2016: 2.88 years).

 

(e)

Range of exercise price

The range of exercise prices for options outstanding at the end of the year was A$0.061—A$0.126 (2017: A$0.079—A$0.14 and 2016: A$0.10—A$0.175).

As the range of exercise prices is wide, refer to Section (c) above for further information in assessing the number and timing of additional shares that may be issued and the cash that may be received upon exercise of those options.

 

(f)

Weighted average fair value

The weighted average fair value of options granted during the year was A$247,089 (2017: A$578,879 and 2016: A$191,589). The total fair value of the options granted during the year is A$247,089 (2017: A$578,879 and 2016: A$191,589).

 

(g)

Option pricing model: ESOP and Investor

Equity-settled transactions

The fair value of the equity-settled share options granted under the ESOP is estimated at the date of grant using a Binomial Model taking into account the terms and conditions upon which the options were granted.

The options issued in the period have vesting criteria based on the following performance conditions:

 

   

Tenure with the Company

 

   

Revenue target

 

   

FDA PMA approval of RECELL for burns

 

   

Initial BARDA procurement under CLIN2 of the BARDA Contract

 

   

US Quotation

 

F-37


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

17.

SHARE-BASED PAYMENT PLANS (CONTINUED)

 

(g)

Option pricing model: ESOP and Investor (continued)

 

i) On May 18, 2017, 17,910,415 options were granted to employees at an exercise price of A$0.085 expiring on May 18, 2027. The following table lists the inputs to the models used for the options granted to employees each year:

 

     2018     2017  

Grant date

     05/18/2017       05/18/2017  

Share price at date of grant

   A$ 0.08     A$ 0.08  

Dividend yield (%)

     0     0

Expected volatility (%)

     90     90

Risk-free interest rate (%)

     1.5     1.5

Expected life of option

     3,650       3,650  

Fair value at date of grant

   A$ 0.075     A$ 0.075  

Option exercise price (A$)

   A$ 0.085     A$ 0.085  

At year end, 7,808,333 options were unvested.

ii) On May 26, 2017, 1,072,916 options were granted to employees at an exercise price of A$0.082 expiring on May 26, 2027. The following table lists the inputs to the models used for the options granted to employees each year:

 

     2018     2017  

Grant date

     05/26/2017       05/26/2017  

Share price at date of grant

   A$ 0.086     A$ 0.086  

Dividend yield (%)

     0     0

Expected volatility (%)

     90     90

Risk-free interest rate (%)

     1.5     1.5

Expected life of option

     3,650       3,650  

Fair value at date of grant

   A$ 0.070     A$ 0.070  

Option exercise price (A$)

   A$ 0.082     A$ 0.082  

At year end, 938,333 options were unvested.

iii) On June 27, 2017, 1,876,666 options were granted to employees at an exercise price of A$0.08 expiring on June 27, 2027. The following table lists the inputs to the models used for the options granted to employees each year:

 

     2018     2017  

Grant date

     06/27/2017       06/27/2017  

Share price at date of grant

   A$ 0.067     A$ 0.067  

Dividend yield (%)

     0     0

Expected volatility (%)

     90     90

Risk-free interest rate (%)

     1.5     1.5

Expected life of option

     3,650       3,650  

Fair value at date of grant

   A$ 0.062     A$ 0.062  

Option exercise price (A$)

   A$ 0.08     A$ 0.08  

 

F-38


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

17.

SHARE-BASED PAYMENT PLANS (CONTINUED)

 

(g)

Option pricing model: ESOP and Investor (continued)

 

At year end, 623,000 options were unvested.

iv) On July 1, 2017, 1,110,000 options were granted to employee at an exercise price of A$0.08 expiring on December 31, 2018. The following table lists the inputs to the models used for the options granted to employees each year:

 

     2018  

Grant date

     07/01/2017  

Share price at date of grant

   A$ 0.069  

Dividend yield (%)

     0

Expected volatility (%)

     90

Risk-free interest rate (%)

     1.5

Expected life of option

     552  

Fair value at date of grant

   A$ 0.031  

Option exercise price (A$)

   A$ 0.08  

At year end, 1,110,000 options were unvested.

v) On September 6, 2017, 4,000,000 options were granted to employee at an exercise price of A$0.063 expiring on September 6, 2027. The following table lists the inputs to the models used for the options granted to employees each year:

 

     2018  

Grant date

     09/06/2017  

Share price at date of grant

   A$ 0.056  

Dividend yield (%)

     0

Expected volatility (%)

     90

Risk-free interest rate (%)

     1.5

Expected life of option

     3,650  

Fair value at date of grant

   A$ 0.052  

Option exercise price (A$)

   A$ 0.063  

At year end, 4,000,000 options were unvested.

vi) On January 3, 2018, 4,000,000 options were granted to employee at an exercise price of A$0.061 expiring on January 3, 2028. The following table lists the inputs to the models used for the options granted to employees each year:

 

     2018  

Grant date

     01/03/2018  

Share price at date of grant

   A$ 0.061  

Dividend yield (%)

     0

Expected volatility (%)

     90

Risk-free interest rate (%)

     1.5

Expected life of option

     3,650  

Fair value at date of grant

   A$ 0.049  

Option exercise price (A$)

   A$ 0.061  

 

F-39


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

17.

SHARE-BASED PAYMENT PLANS (CONTINUED)

 

(g)

Option pricing model: ESOP and Investor (continued)

 

At year end, 4,000,000 options were unvested.

 

(h)

Long-term incentive rights

On November 30, 2017, 50,000,000 LTI’s were issued to Dr. Michael Perry based on the following milestones:

 

  1.

Tenure – a total of 16,666,666 LTIs issued but to vest over the three-year period commencing July 1, 2017;

 

  2.

Company Share Price – a total of 16,666,666 LTIs issued but to vest in three equal tranches subject to the Volume Weighted Average Price (VWAP) of Company share price (as at close of trade on the ASX on relevant date) achieving multiples of 2x, 3x and 4x the Company’s share price at the time of shareholder approval; and

 

  3.

Milestone performance – a total of 16,666,668 LTIs issued, but to vest in two equal tranches with one tranche to vest upon the achievement of the following milestones:

 

  a.

FDA PMA approval of RECELL for burns

 

  b.

Initial BARDA procurement under CLIN2 of the BARDA Contract

 

     Tranche 1     Tranche 2     Tranche 3     Tranche 4  

Grant date

     11/30/2017       11/30/2017       11/30/2017       11/30/2017  

Share price at date of grant

   A$ 0.061     A$ 0.061     A$ 0.061     A$ 0.061  

Exercise price

   A$ nil     A$ nil     A$ nil     A$ nil  

Vesting hurdle

     n/a       n/a       n/a     A$ 0.122  

Expiry period

     11/30/2027       11/30/2027       11/30/2027       11/30/2027  

Dividend yield (%)

     0     0     0     0

Expected volatility (%)

     70     70     70     70

Risk-free interest rate (%)

     2.47     2.47     2.47     2.47

 

     Tranche 5     Tranche 6     Tranche 7     Tranche 8  

Grant date

     11/30/2017       11/30/2017       11/30/2017       11/30/2017  

Share price at date of grant

   A$ 0.061     A$ 0.061     A$ 0.061     A$ 0.061  

Exercise price

   A$ nil     A$ nil     A$ nil     A$ nil  

Vesting hurdle

   A$ 0.183     A$ 0.244       n/a       n/a  

Expiry period

     11/30/2027       11/30/2027       11/30/2027       11/30/2027  

Dividend yield (%)

     0     0     0     0

Expected volatility (%)

     70     70     70     70

Risk-free interest rate (%)

     2.47     2.47     2.47     2.47

 

18.

SEGMENT INFORMATION

Operating segments are identified on the basis of internal reports about components of the Company that are regularly reviewed by the chief operating decision maker to allocate resources to the segment and to assess its performance. The Company’s chief operating decision maker has been identified as the Chief Executive Officer.

 

F-40


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

18.

SEGMENT INFORMATION (CONTINUED)

 

The Chief Executive Officer reviews the financial and operating performance of the business primarily from a geographic perspective. On this basis, management have identified three reportable operating segments being the Asia Pacific, Europe and Americas including Canada. The Chief Executive Officer monitors the performance of all these segments separately. The Company does not operate in any other geographic segment.

The Asia Pacific operating segment derives its revenues from the sale of the RECELL System.

The Europe operating segment derives its revenues from the sale of the RECELL System.

The America operating segment derives its revenues primarily from fees received under its contracts with BARDA. The RECELL System was not approved for sale within the U.S. until subsequent to June 30, 2018, on September 20, 2018.

The Chief Executive Officer assesses the performance of the operating segments based on a measure of gross margin and net profit before tax.

Unallocated

The following items of income and expense and associated assets are not allocated to operating segments as they are not considered part of the core operations of any segment:

 

   

Corporate revenue

 

   

Corporate charges

 

   

Amortization of intellectual property

The segment information provided to the Chief Executive Officer for the reportable segments for the year ended June 30, 2018 is as follows:

 

     Asia Pacific     EMEA     Americas     Total  

Year ended June 30, 2018

        

Revenue

        

Sale of goods

   A$ 709,907     A$ 488,955     A$ —       A$ 1,198,862  

Other income from external customers

     —         2,961       10,104,082       10,107,043  

Interest received

     59,552       438       5,667       65,657  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue and other income per consolidated statement of profit or loss and other comprehensive income

   A$ 769,459     A$ 492,354     A$ 10,109,749     A$ 11,371,562  
  

 

 

   

 

 

   

 

 

   

 

 

 

Segment net loss before tax benefit

   A$ (1,341,200   A$ (2,181,622   A$ (9,539,296   A$ (13,062,118

Reconciliation of segment net result before tax to loss before income tax:

        

Corporate charges including share-based expenses

           (4,842,833
        

 

 

 

Loss before income tax benefit

         A$ (17,904,951
        

 

 

 

The Company’s revenue in its Americas including Canada operating segment includes A$9,650,783 from BARDA, representing 85%.

 

F-41


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

18.

SEGMENT INFORMATION (CONTINUED)

 

Revenue is attributed to geographic location based on the location of the customers. The percentages of external revenues from external customers that are attributable to foreign countries are as shown below:

 

     2018     2017     2016  

Australia

     6.8     9.4     15.4

Other

     93.2     90.6     84.6
  

 

 

   

 

 

   

 

 

 

Total revenue

     100.0     100.0     100.0
  

 

 

   

 

 

   

 

 

 

 

     Asia Pacific      EMEA      Americas      Total  

Year ended June 30, 2018

           

Segment assets

           

Segment operating assets

   A$ 532,926      A$ 579,081      A$ 7,079,653      A$ 18,191,660  

Segment non-current assets

     5,662        18,215        703,100        726,977  
  

 

 

    

 

 

    

 

 

    

 

 

 

Unallocated assets

     —          —          —          4,098,377  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets per the consolidated statement of financial position

            A$ 23,017,014  
           

 

 

 

Segment liabilities

           

Segment operating liabilities

   A$ 189,531      A$ 176,461      A$ 3,314,423      A$ 3,680,415  

Unallocated liabilities

     —          —          —          337,040  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities per the consolidated statement of financial position

            A$ 4,017,455  
           

 

 

 

 

     Asia Pacific     EMEA     Americas     Total  

Year ended June 30, 2017

        

Revenue

        

Sale of goods

   A$ 452,662     A$ 448,714     A$ —       A$ 901,376  

Other revenues from external customers

     197,488       23,537       6,886,236       7,107,261  

Interest received

     116,559       1,218       5,932       123,709  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue and other income per consolidated statement of profit or loss and other comprehensive income

   A$ 766,709     A$ 473,469     A$ 6,892,168     A$ 8,132,346  
  

 

 

   

 

 

   

 

 

   

 

 

 

Segment net operating loss before tax

   A$ (1,559,592   A$ (2,836,165   A$ (2,373,062   A$ (6,768,819

Reconciliation of segment net result before tax to loss before income tax:

        

Corporate charges including share-based expenses

           (5,790,442
        

 

 

 

Loss before income tax

         A$ (12,559,261
        

 

 

 

 

F-42


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

18.

SEGMENT INFORMATION (CONTINUED)

 

     Asia Pacific      EMEA      Americas      Total  

Year ended June 30, 2017

           

Segment assets

           

Segment operating assets

   A$ 227,359      A$ 1,166,946      A$ 2,342,846      A$ 3,737,150  

Segment non-current assets

     6,624        20,375        360,380        387,380  
  

 

 

    

 

 

    

 

 

    

 

 

 

Unallocated assets

     —          —          —          3,156,011  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets per the consolidated statement of financial position

            A$ 7,280,541  
           

 

 

 

Segment liabilities

           

Segment operating liabilities

   A$ 153,502      A$ 468,996      A$ 1,743,657      A$ 2,366,155  

Unallocated liabilities

     —          —          —          179,934  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities per the consolidated statement of financial position

            A$ 2,546,089  
           

 

 

 

 

     Asia Pacific     EMEA     Americas     Total  

Year ended June 30, 2016

        

Revenue

        

Sale of goods

   A$ 436,101     A$ 565,906     A$ —       A$ 1,002,007  

Other revenues from external customers

     2,358       474       2,431,321       2,434,153  

Interest received

     109,789       492       83       110,364  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue and other income per consolidated statement of profit or loss and other comprehensive income

   A$ 548,248     A$ 566,872     A$ 2,431,405     A$ 3,546,524  
  

 

 

   

 

 

   

 

 

   

 

 

 

Segment net operating loss before tax

   A$ (1,553,744   A$ (3,222,858   A$ (1,461,569   A$ (6,238,171

Reconciliation of segment net result before tax to loss before income tax:

        

Corporate charges

           (5,005,672
        

 

 

 

Loss before income tax

         A$ (11,243,843
        

 

 

 

 

     Continuing Operations  
     Asia Pacific      EMEA      Americas      Total  

Year ended June 30, 2016

           

Segment assets

           

Segment operating assets

   A$ 254,672      A$ 1,649,931      A$ 2,746,915      A$ 4,651,518  

Unallocated assets

     —          —          —          3,951,391  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets per the consolidated statement of financial position

            A$ 8,602,909  
           

 

 

 

Segment liabilities

           

Segment operating liabilities

   A$ 163,992      A$ 622,146      A$ 727,167      A$ 1,513,305  

Unallocated liabilities

     —          —          —          237,087  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities per the consolidated statement of financial position

            A$ 1,750,392  
           

 

 

 

 

F-43


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

19.

FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES

The Company’s principal financial instruments comprise receivables, payables, cash and short-term deposits.

The Company manages its exposure to key financial risks, including interest rate and foreign currency risk in accordance with the Company’s financial risk management policy. The objective of the policy is to support the delivery of the Company’s financial targets whilst protecting future financial security.

The main risks arising from the Company’s financial instruments are interest rate risk, foreign currency risk, credit risk and liquidity risk. The Company uses different methods to measure and manage different types of risk to which it is exposed. These include monitoring levels of exposure to interest rate and foreign exchange risk and assessments of market forecasts for interest rates and foreign exchange. Ageing analyses and monitoring of specific credit allowances are undertaken to manage credit risk, and liquidity risk is monitored through the development of future rolling cash flow forecasts. The Board reviews and agrees policies for managing each of these risks as summarized below.

Primary responsibility for identification and control of financial risks rests with the Finance Manager under the authority of the Board. The Board reviews and agrees policies for managing each of the risks identified below including foreign currency and interest rate risk, credit allowances and future cash flow forecast projections.

At the reporting date, the Company had the following financial assets and liabilities:

 

     As of June 30,  
     2018      2017  

Financial Assets

     

Cash and cash equivalents

   A$ 14,825,532      A$ 3,790,491  

Trade and other receivables

     5,437,357        2,070,534  

Financial Liabilities

     

Trade and other payables

     (3,487,582      (2,363,734

Provisions

     (395,535      (182,355
  

 

 

    

 

 

 

Net

   A$ 16,379,772      A$ 3,314,936  
  

 

 

    

 

 

 

Risk Exposures and Responses

Interest rate risk

The Company’s exposure to market interest rates relates primarily to short-term deposits with a floating interest rate. At reporting date, the Company had the following mix of financial assets exposed to Australian Variable interest rate risk:

 

     As of June 30,  
     2018      2017  

Financial Assets

     

Cash and cash equivalents

   A$ 14,825,532      A$ 3,790,491  
  

 

 

    

 

 

 

Net exposure

   A$ 14,825,532      A$ 3,790,491  
  

 

 

    

 

 

 

The Company’s policy is to manage its finance costs and revenue using a mix of fixed and variable interest rates depending on the forecast funding requirements of the Company. At June 30, 2018 and 2017, there were no cash and cash equivalents recorded at a fixed rate of interest.

 

F-44


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

19.

FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES (CONTINUED)

 

The following sensitivity analysis is based on the interest rate exposures in existence at the reporting date. The 1% sensitivity is based on reasonably possible changes over a financial year, using the observed range of historical rates for the preceding three-year period.

At June 30, 2018, if interest rates had moved, as illustrated in the table below, with all other variables held constant, post tax loss and equity would have been affected as follows:

 

Judgements of reasonably possible

movements:

  

Post Tax Loss

(Higher)/Lower

    

Equity

Higher/(Lower)

 
     2018      2017      2018     2017  

+1% (100 basis points)

   A$ 148,255      A$ 37,905      A$ 148,255     A$ 37,905  

-1% (100 basis points)

     (148,255      (37,905      (148,255     (37,905

The movements in loss are due to higher/lower finance revenue from variable rate cash balances.

Foreign currency risk

The Company has investment operations in Europe and the United States. The Company’s consolidated statement of financial position can be affected by movements in exchange rates and the Company does not currently hedge this exposure.

The Company also has transactional currency exposures. Such exposures arise from sales or purchases by an operating entity in currencies other than the functional currency.

Approximately 93% (2017: 94% and 2016: 87%) of the Company’s sales are denominated in currencies other than the functional currency, whilst approximately 74% (2017: 60% and 2016: 51%) of costs are denominated in the functional currency.

At June 30, 2018, the Company had the following exposure to foreign currencies:

 

     As of June 30,  
     2018      2017  

Financial assets

     

Cash and cash equivalents

   A$ 13,046,513      A$ 1,726,568  

Trade and other receivables

     2,847,542        926,501  
  

 

 

    

 

 

 
     15,894,055        2,653,069  
  

 

 

    

 

 

 

Financial liabilities

     

Trade and other payables

     (3,356,546      (1,209,902
  

 

 

    

 

 

 

Net exposure

   A$ 12,537,509      A$ 1,443,167  
  

 

 

    

 

 

 

The following sensitivity is based on the foreign currency risk exposures in existence at the reporting date. The percentage sensitivity is based on reasonably possible changes over a financial year, using the observed range of historical rates for the preceding two-year period.

 

F-45


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

19.

FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES (CONTINUED)

 

At June 30, 2018, had the Australian Dollar moved, as illustrated in the table below, with all other variables held constant, post tax loss and equity would have been affected as follows:

 

Judgments of reasonably possible
movements:
  

Post Tax Loss

(Higher)/Lower

   

Equity

Higher/(Lower)

 
     2018      2017     2016     2018      2017     2016  

AUD/GBP + 10%

   A$ 54,761      A$ (62,731   A$ (74,765   A$ 54,761      A$ (62,731   A$ (74,765

AUD/GBP – 5%

     27,380        31,366       37,383       27,380        31,366       37,383  

AUD/USD +10%

     1,827,003        (67,791     (70,732     1,827,003        (67,791     (70,732

AUD/USD – 5%

     913,502        33,895       35,366       913,502        33,895       35,366  

AUD/EUR +10%

     8,663        (13,795     (22,151     8,663        (13,795     (22,151

AUD/EUR – 5%

     4,332        6,897       11,076       4,332        6,897       11,076  

Management believe the reporting date risk exposures are representative of the risk exposure inherent in the financial instruments. The Company has no processes and objectives for managing foreign exchange risks.

Credit risk

Credit risk arises from the financial assets of the Company, which comprise cash and cash equivalents and trade and other receivables. The Company’s exposure to credit risk arises from potential default of the counter party, with a maximum exposure equal to the carrying amount of these instruments.

The Company does not hold any credit derivatives to offset its credit exposure.

The Company trades only with recognized, creditworthy third parties, and as such collateral is not requested nor is it the Company’s policy to securitize its trade and other receivables.

It is the Company’s policy that all customers who wish to trade on credit terms are subject to credit verification procedures including an assessment of their independent credit rating, financial position, past experience and industry reputation. Risk limits are set for each individual customer in accordance with parameters set by the Board. These risk limits are regularly monitored.

In addition, receivable balances are monitored on an on-going basis with the result that the Company’s exposure to bad debts is not significant.

A significant balance of cash is held in National Australia Bank. This is a highly rated institution which effectively manages its risk profile and therefore the Company considers its cash balances to be secure.

There is no concentration of debt amongst the creditors.

Liquidity risk

The Company’s objective is to maintain a balance between continuity of funding and flexibility through the use of bank overdrafts, bank loans and finance leases.

The table below reflects all contractually fixed pay-offs and receivables for settlement, repayments and interest resulting from recognized financial assets and liabilities. For all obligations, the respective undiscounted cash flows for the respective upcoming fiscal years are presented. Cash flows for financial assets and liabilities without fixed amount or timing are based on the conditions existing at June 30, 2018.

 

F-46


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

19.

FINANCIAL RISK MANAGEMENT OBJECTIVES AND POLICIES (CONTINUED)

 

The remaining contractual maturities of the Company’s financial liabilities are:

 

     As of June 30,  
     2018      2017  

6 months or less

   A$ 3,487,582      A$ 2,363,734  

6-12 months

     —          —    

1-3 years

     —          —    
  

 

 

    

 

 

 
   A$ 3,487,582      A$ 2,363,734  
  

 

 

    

 

 

 

Maturity analysis of financial assets and liabilities are based on management’s expectation.

The risk implied from the values shown in the table below, reflects a balanced view of cash inflows and outflows. Trade payables and other financial liabilities mainly originate from the financing of assets used in our on-going operations such as property, plant, equipment and investments in working capital including inventories and trade receivables. These assets are considered in the Company’s overall liquidity risk.

 

Year ended June 30, 2018    < 6 months      6-12 months      1-5 years      Total  

Financial assets

           

Cash and cash equivalents

   A$ 14,825,532      A$ —        A$ —        A$ 14,825,532  

Trade and other receivables

     5,437,357        —          —          5,437,357  
  

 

 

    

 

 

    

 

 

    

 

 

 
     20,262,889        —          —          20,262,889  
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

           

Trade and other payables

     (3,487,582      —          —          (3,487,582
  

 

 

    

 

 

    

 

 

    

 

 

 

Net maturity

   A$ 16,775,307      A$ —        A$ —        A$ 16,775,307  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

Year ended June 30, 2017    < 6 months      6-12 months      1-5 years      Total  

Financial assets

           

Cash and cash equivalents

   A$ 3,790,491      A$ —        A$ —        A$ 3,790,491  

Trade and other receivables

     2,070,534        —          —          2,070,534  
  

 

 

    

 

 

    

 

 

    

 

 

 
     5,861,025        —          —          5,861,025  
  

 

 

    

 

 

    

 

 

    

 

 

 

Financial liabilities

           

Trade and other payables

     (2,363,734      —          —          (2,363,734
  

 

 

    

 

 

    

 

 

    

 

 

 

Net maturity

   A$ 3,497,291      A$ —        A$ —        A$ 3,497,291  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

F-47


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

20.

COMMITMENTS AND CONTINGENCIES

Finance leases as lessee

The Company’s furniture and IT equipment are held under lease arrangements. As of June 30, 2018, the net carrying amount of the furniture and IT equipment held under lease arrangements is A$159,043 (2017: A$66,408 and 2016: A$nil). The Company’s finance lease liabilities, which are secured by the related assets held under finance leases, are classified as follows:

 

     2018  

Finance lease liabilities

  

Current:

   A$ 86,883  

Non-current:

     72,160  
  

 

 

 
   A$ 159,043  
  

 

 

 

 

     Minimum Lease Payment Due         
     Within 1 Year      1-5 Years      After 5 Years      Total  

June 30, 2018

           

Lease Payments

     114,650        92,515        —          207,165  

Finance charges

     (27,767      (20,355      —          (48,122

Net Present Values

     86,883        72,160        —          159,043  
  

 

 

    

 

 

    

 

 

    

 

 

 

Operating leases as lessee

The Company leases space under operating leases. Future minimum lease payments as of June 30, 2018 are as follows:

 

     Minimum Lease Payment Due         
     Within 1 Year      1-5 Years      After 5 Years      Total  

June 30, 2018

     525,919        856,541        —          1,382,460  

June 30, 2017

     344,431        879,079        —          1,223,509  

June 30, 2016

     190,706        438,554        —          629,260  

 

21.

AUDITORS’ REMUNERATION

The auditors of Avita Medical Limited and its subsidiaries are Grant Thornton Audit Pty Ltd.

 

     Year ended June 30,  
     2018      2017      2016  

Amounts received or due and receivable by Grant Thornton Audit Pty Ltd for:

        

An audit or review of the financial report of the Company and any other entity in the Company

   A$ 182,440      A$ 120,366      A$ 131,586  

Other services in relation to the entity and any other entity in the Company - Taxation services

     46,811        62,635        30,397  
  

 

 

    

 

 

    

 

 

 
   A$ 229,251      A$ 183,001      A$ 161,983  
  

 

 

    

 

 

    

 

 

 

 

F-48


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

22.

PARENT ENTITY INFORMATION

 

Information relating to Avita Medical Limited:    As of June 30,  
     2018     2017  

Current assets

   A$ 4,098,378     A$ 3,156,011  

Total assets

     4,098,378       3,156,011  

Current liabilities

     (337,040     (179,934

Total liabilities

     (337,040     (179,934
  

 

 

   

 

 

 

Net assets

   A$ 3,761,338     A$ 2,976,077  

Issued capital

   A$ 162,801,028     A$ 134,806,022  

Accumulated losses

     (163,541,196     (135,034,498

Share option reserves

     4,501,506       3,204,553  
  

 

 

   

 

 

 

Total shareholders’ equity

   A$ 3,761,338     A$ 2,976,077  

Loss of parent entity after income tax

   A$ (3,258,675   A$ (4,741,808

Total comprehensive loss of the parent entity

   A$ (3,258,675   A$ (4,741,808

Details of any contingent liabilities of the parent entity

     None       None  

Details of any contractual commitments by the parent entity for the acquisition of property, plant and equipment

     None       None  

During the period, the parent entity impaired A$21,368,073 (2017: A$5,983,551) of intercompany loans to subsidiaries and investments in subsidiaries. The impairment charges are eliminated on consolidation.

 

23.

DEED OF CROSS GUARANTEE

The following entities are party to a deed of cross guarantee under which each company guarantees the debts of the others:

 

   

Avita Medical Limited

 

   

C3 Operations Pty Ltd

 

   

Visiomed Group Pty Ltd

 

   

Infamed Pty Limited

By entering into the deed, the wholly owned entities have been relieved from the requirement to prepare a financial report and Directors’ Report under Australian Securities and Investments Commission (‘ASIC’) Corporations (Wholly-owned Companies) Instrument 2016/785. The above companies represent a ‘Closed Group’ for the purposes of the Class Order, and as there are no other parties to the Deed of Cross guarantee that are controlled by Avita Medical Limited, they also represent the ‘Extended Closed Group’.

 

F-49


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

23.

DEED OF CROSS GUARANTEE (CONTINUED)

 

Set out below is a consolidated statement of profit or loss and other comprehensive income and consolidated statement of financial position of the ‘Closed Group’.

 

Continuing operations    Year ended June 30,  
     2018     2017     2016  

Sale of goods

   A$ 709,907     A$ 452,662     A$ 436,101  

Other revenue

     59,552       129,958       109,789  
  

 

 

   

 

 

   

 

 

 

Revenue

     769,459       582,620       545,890  

Cost of sales

     (331,244     (243,708     (210,200
  

 

 

   

 

 

   

 

 

 

Gross profit

     438,215       338,912       335,690  
  

 

 

   

 

 

   

 

 

 

Other income

     —         184,088       2,226,911  

Operating costs

      

Administrative expenses

     (4,660,971     (3,085,503     (3,782,183

Research and development expenses

     (43,048     (2,365,647     (2,136,849

Impairment of inter-company loans

     (21,368,073     (5,983,551     (7,515,021

Sales and marketing expenses

     (1,250,976     (834,600     (978,429

Finance costs

     —         (41     (3
  

 

 

   

 

 

   

 

 

 

Loss from continuing operations before income tax

     (26,884,853     (11,746,342     (11,849,884

Profit from discontinued operations

     —         —         269,394  

Income tax benefit

     1,385,796       1,048,634       972,282  
  

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period

   A$ (25,499,057   A$ (10,697,708   A$ (10,608,208
  

 

 

   

 

 

   

 

 

 

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

23.

DEED OF CROSS GUARANTEE (CONTINUED)

 

     As of June 30,  
     2018      2017  

Current Assets

     

Cash and cash equivalents

   A$ 1,779,019      A$ 2,063,923  

Trade and other receivables

     2,589,816        1,144,033  

Prepayments

     130,055        155,112  

Inventories

     132,414        26,925  

Investments

     —          —    
  

 

 

    

 

 

 

Total Current Assets

     4,631,304        3,389,993  
  

 

 

    

 

 

 

Non-Current Assets

     

Plant and equipment

     5,662        6,625  
  

 

 

    

 

 

 

Total Non-Current Assets

     5,662        6,625  
  

 

 

    

 

 

 

TOTAL ASSETS

     4,636,966        3,396,618  
  

 

 

    

 

 

 

LIABILITIES

     

Current Liabilities

     

Trade and other payables

     477,366        248,497  

Provisions

     49,205        84,938  
  

 

 

    

 

 

 

Total Current Liabilities

     526,571        333,435  
  

 

 

    

 

 

 

TOTAL LIABILITIES

     526,571        333,435  
  

 

 

    

 

 

 

NET ASSETS

     4,110,395        3,063,183  
  

 

 

    

 

 

 

EQUITY

     

Contributed equity

     162,801,028        134,806,022  

Accumulated losses

     (163,194,156      (134,977,180

Reserves

     4,503,523        3,234,341  
  

 

 

    

 

 

 

TOTAL EQUITY

   A$ 4,110,395      A$ 3,063,183  
  

 

 

    

 

 

 

 

24.

INVESTMENTS

 

     As of 30 June  
     2018      2017      2016  

Investment in MVP shares

   $ —        $ —        $ 453,892  

Fair value gain on investment

     —          —          265,261  
  

 

 

    

 

 

    

 

 

 

Carrying amount of investment

   $ —        $ —        $ 719,153  
  

 

 

    

 

 

    

 

 

 

The 2016 Investments of $719,153 was due to the holding in escrow of 117,894 shares of Medical Developments International Ltd (ASX: MVP) originating from the sale of Avita’s Respiratory Business in February 2016. Consideration for the divestment was $2,029,478 in cash plus the MVP shares which were valued at $453,892 at the closing of the transaction on February 5, 2016. The statement of profit and loss reflects a fair value gain of $265,261 in other comprehensive income on these escrowed shares, as these shares had a fair value at the reporting date of $719,153.

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)

(IN AUSTRALIAN DOLLARS)

 

24.

INVESTMENTS (CONTINUED)

 

As of June 30, 2016, all MVP shares have been sold for proceeds amounting to $627,837 resulting in a loss of $91,316 which was recognised in administrative expenses.

 

25.

EVENTS AFTER THE REPORTING DATE

On September 20, 2018, the U.S. Food and Drug Administration (FDA) approved the Company’s application to market the RECELL System to treat patients with acute thermal burns in the U.S.

Subsequent to June 30, 2018 the Company completed a series of equity transactions in in which the Company received a total of A$45,014,900 in gross proceeds. During the year ended June 30, 2018 the Company completed an institutional placement of shares to international and Australian institutional and sophisticated investors. The institutional placement included a second tranche totaling A$3.250 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the net proceeds of A$3.041 million were received by the Company on July 26, 2018. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the Company issued 65 million shares at a price of A$0.050 per share and received gross proceeds of A$3,250,000 on July 26, 2018. Also subsequent to year end, on December 4, 2018 the Company completed the first tranche of an institutional placement of in which it issued 310,047,015 fully paid ordinary shares at a price of A$0.080 per share raising gross proceeds of A$24,803,761. The institutional placement included a second tranche totaling A$15.196 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on January 14, 2019, and the Company issued 189,952,985 shares at a price of A$0.080 per share and received gross proceeds of A$15,196,239 on January 14, 2019. In addition, on January 11, 2019 the Company complete a Share Purchase Plan under which it issued 22,061,250 shares of stock at a price of A$0.080 per share and received gross proceeds of A$1,764,900.

 

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AVITA MEDICAL LIMITED

CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS

AND OTHER COMPREHENSIVE LOSS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

            Half-year ended December 31,  
     Note      2018     2017  

Continuing operations

       

Sale of goods

     2      A$ 1,813,195     A$ 607,761  

Cost of sales

        (570,315     (264,833
     

 

 

   

 

 

 

Gross profit

        1,242,880       342,928  

BARDA income

     2        5,009,137       3,856,716  

Other income

     2        103,626       37,595  
     

 

 

   

 

 

 

Total other income

        5,112,763       3,894,311  

Operating costs

       

Sales and marketing expenses

        (6,931,241     (2,815,698

Product development expenses

        (7,080,042     (5,058,518

Corporate and administrative expenses

        (6,865,250     (2,873,511

Share-based payment expense

        (1,043,694     (726,856

Finance costs

        (14,807     (13,253
     

 

 

   

 

 

 

Total operating costs

        (21,935,034     (11,487,836
     

 

 

   

 

 

 

Loss from continuing operations before income tax expense

        (15,579,391     (7,250,597

Income tax expense

        —         —    
     

 

 

   

 

 

 

Loss for the period

        (15,579,391     (7,250,597

Other comprehensive income (loss)

       

Items that may be reclassified subsequently to profit or loss:

       

Foreign currency translation

        1,374,144       (55,390
     

 

 

   

 

 

 

Other comprehensive loss for the period, net of tax

        1,374,144       (55,390
     

 

 

   

 

 

 

Total other comprehensive loss for the period

      A$ (14,205,247   A$ (7,305,987
     

 

 

   

 

 

 

Loss for the period attributable to owners of the parent

        (15,579,391     (7,250,597
     

 

 

   

 

 

 

Total comprehensive loss attributable to owners of the parent

      A$ (14,205,247   A$ (7,305,987
     

 

 

   

 

 

 
Earnings Per Share        

Basic and diluted loss per share from continuing operations

      A$ (1.59) cents     A$ (0.91) cents  

The accompanying notes form part of the condensed consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

     Note      December 31, 2018     June 30, 2018  

ASSETS

       

Current assets

       

Cash and cash equivalents

      A$ 30,342,360     A$ 14,825,532  

Trade and other receivables

        2,536,923       5,437,357  

Prepayments and other assets

        931,431       855,716  

Inventories

        1,143,062       1,155,826  
     

 

 

   

 

 

 

Total current assets

        34,953,776       22,274,431  
     

 

 

   

 

 

 

Non-current assets

       

Plant and equipment

        1,299,831       742,583  

Intangible assets

        93,775       —    
     

 

 

   

 

 

 

Total non-current assets

        1,393,606       742,583  
     

 

 

   

 

 

 

TOTAL ASSETS

      A$ 36,347,382     A$ 23,017,014  
     

 

 

   

 

 

 

LIABILITIES

       

Current liabilities

       

Trade and other payables

        4,483,406       3,487,582  

Provisions

        533,660       395,535  
     

 

 

   

 

 

 

Total current liabilities

        5,017,066       3,883,117  
     

 

 

   

 

 

 

Finance lease

        83,032       134,338  
     

 

 

   

 

 

 

Total non-current liabilities

        83,032       134,338  
     

 

 

   

 

 

 

TOTAL LIABILITIES

        5,100,098       4,017,455  
     

 

 

   

 

 

 

NET ASSETS

      A$ 31,247,284     A$ 18,999,559  
     

 

 

   

 

 

 

EQUITY

       

Equity attributable to equity holders of the parent:

       

Contributed equity

     6        188,210,306       162,801,028  

Accumulated losses

        (164,172,270     (148,592,879

Reserves

        7,209,248       4,791,410  
     

 

 

   

 

 

 

TOTAL EQUITY

      A$ 31,247,284     A$ 18,999,559  
     

 

 

   

 

 

 

The accompanying notes form part of the condensed consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

     Half-year ended December 31,  
     2018     2017  

Cash flows from operating activities

    

Payments to suppliers and employees

   A$ (20,305,643   A$ (11,943,480

Interest paid

     —         (13,253

BARDA receipts and other income received

     6,104,306       3,676,182  

Receipts from customers

     1,204,802       367,933  

R&D tax refunds received

     2,440,803       —    

Interest received

     97,253       37,593  
  

 

 

   

 

 

 

Net cash flows used in operating activities

     (10,458,479     (7,875,025
  

 

 

   

 

 

 

Cash flows from investing activities

    

Payments for plant & equipment

     (722,472     (63,672
  

 

 

   

 

 

 

Net cash flows used in investing activities

     (722,472     (63,672
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from issuance of shares

     28,053,762       17,028,964  

Capital raising expenses

     (2,689,423     (1,048,359
  

 

 

   

 

 

 

Net cash flows provided by financing activities

     25,364,339       15,980,605  
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     14,183,388       8,041,908  

Cash and cash equivalents at beginning of period

     14,825,532       3,790,491  

Impact of foreign exchange

     1,333,440       (55,390
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   A$ 30,342,360     A$ 11,777,009  
  

 

 

   

 

 

 

For the purpose of the half-year Statement of Cash Flows, cash and cash equivalents are comprised of the following:

 

     As of December 31,  
     2018      2017  

Cash at bank and in hand

   A$ 29,084,452      A$ 1,403,330  

Short-term deposits

     1,257,908        10,373,679  
  

 

 

    

 

 

 

Total Cash and Cash Equivalents

   A$ 30,342,360      A$ 11,777,009  
  

 

 

    

 

 

 

The accompanying notes form part of the condensed consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

    Note     Contributed
equity
    Accumulated
losses
    Share-based
payment
reserve
    Foreign
currency
translation
reserve
    Total  

As of July 1, 2018

    A$ 162,801,028     A$ (148,592,879   A$ 4,505,148     A$ 286,262     A$ 18,999,559  

Loss for the period

      —         (15,579,391     —         —         (15,579,391

Other comprehensive income

      —         —         —         1,374,144       1,374,144  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period

      —         (15,579,391     —         1,374,144       (14,205,247
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

           

Share-based payments

      —         —         1,043,694       —         1,043,694  

New shares

    6       28,098,701       —         —         —         28,098,701  

Cost of share placement

    6       (2,689,423     —         —         —         (2,689,423
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at December 31, 2018

    A$ 188,210,306     A$ (164,172,270   A$ 5,548,842     A$ 1,660,406     A$ 31,247,284  
   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

    Contributed
equity
    Accumulated
losses
    Share-based
payment
reserve
    Foreign
currency
translation
reserve
    Total  

As of July 1, 2017

  A$ 134,806,022       $A(132,218,352   A$ 2,811,179     A$ (277,017   A$ 5,121,832  

Loss for the period

    —         (7,250,597     —         —         (7,250,597

Other comprehensive income

    —         —         —         (55,390     (55,390
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the period

    —         (7,250,597     —         (55,390     (7,305,987
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

         

Share-based payments

    —         —         726,855       —         726,855  

New shares

    17,028,964       —         —         —         17,028,964  

Cost of share placement

    (1,048,359     —         —         —         (1,048,359

Transfer of expired options

    —         141,188       (141,188     —         —    
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Balance at December 31, 2017

  A$ 150,786,627       A$(139,327,761   A$ 3,396,846     A$ (332,407   A$ 14,523,305  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes form part of the condensed consolidated financial statements.

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

1.

BASIS OF PREPARATION AND ACCOUNTING POLICIES

 

a)

Basis of preparation

This general purpose condensed financial report for the half-year ended December 31, 2018 has been prepared in accordance with International Accounting Standards Board (IASB). The Company is a for-profit entity for financial reporting purposes under Australian Accounting Standards. The Parent Company’s functional and presentation currency is AUD ($).

This half-year financial report does not include all notes of the type normally included within the annual financial report and therefore cannot be expected to provide as full an understanding of the financial performance, financial position and financing and investing activities of the consolidated entity as the full financial report.

It is recommended that the half-year financial report be read in conjunction with the annual report for the year ended June 30, 2018 and considered together with any subsequent public announcements made by Avita Medical Limited in accordance with the continuous disclosure obligations of the ASX listing rules.

This financial report has been prepared on the going concern basis. The accounting policies have been applied consistently throughout the Company for the purposes of preparation of these interim financial statements. Certain items on the Consolidated Financial Statements and notes for the prior periods have been reclassified to conform to the current period presentation.

 

b)

Changes in accounting policy

The interim financial statements have been prepared in accordance with the same accounting policies adopted in the Company’s last annual financial statements for the year ended June 30, 2018, except as described below. Note that the changes in accounting policies specified below only apply to the current period. The accounting policies included in the Company’s last annual financial statements for the year ended June 30, 2018 are the relevant policies for the purposes of comparatives.

IFRS 15 Revenue from Contracts with Customers and IFRS 9 Financial Instruments (2014) became effective for periods beginning on or after January 1, 2018. Accordingly, the Company applied IFRS 15 and IFRS 9 for the interim period ended December 31, 2018. Changes to the Company’s accounting policies arising from these standards are summarized below:

IFRS 9 Financial Instruments

IFRS 9 Financial Instruments replaces IAS 39 Financial Instruments: Recognition and Measurement requirements. It makes major changes to the previous guidance on the classification and measurement of financial assets and introduces an ‘expected credit loss’ model for impairment of financial assets.

The adoption of this standard has no impact on the current or previous reporting period and as such there have been no adjustments to the opening balance of retained earnings.

IFRS 15 – Revenue from contracts with customers

Revenue is comprised mainly from funding from BARDA and from the sale of goods. To determine whether to recognize revenue, the Company follows a five-step process:

 

  1.

Identifying the contract with a customer,

 

F-57


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

1.

BASIS OF PREPARATION AND ACCOUNTING POLICIES (CONTINUED)

 

b)

Changes in accounting policy (continued)

 

  2.

Identifying the performance obligations,

 

  3.

Determining the transaction price,

 

  4.

Allocating the transaction price to the performance obligation,

 

  5.

Recognizing revenue when performance obligation is satisfied.

Revenue from the sales of goods is recognized at a point in time, when the Company satisfies performance obligations by transferring the promised goods to its customers. The Company recognizes contract liabilities for consideration received in respect of unsatisfied performance obligations and reports these amounts as other liabilities in the statement of financial position. Similarly, if the Company satisfies a performance obligation before it receives the consideration, the Company recognizes either a contract asset or a receivable in its statement of financial position, depending on whether something other than the passage of time is required before the consideration is due.

The adoption of this standard has no impact on the current or previous reporting period and as such there have been no adjustments to the opening balance of retained earnings.

Accounting Standards issued but not yet effective and not been adopted early by the Company

IFRS 16 Leases

IFRS 16:

 

   

replaces IAS 17 Leases and some lease-related Interpretations,

 

   

requires all leases to be accounted for ‘on-balance sheet’ by lessees, other than short-term and low value asset leases,

 

   

provides new guidance on the application of the definition of lease and on sale and lease back accounting,

 

   

largely retains the existing lessor accounting requirements in IAS 17,

 

   

requires new and different disclosures about leases.

A number of new and revised standards became effective for the first time to annual periods beginning on or after January 1, 2017. Information on the more significant standard is presented below.

Based on the entity’s assessment, it is expected that the first-time adoption of IFRS 16 for the year ending June 30, 2020 will have a material impact on the transactions and balances recognized in the financial statements, in particular:

 

   

lease assets and financial liabilities on the balance sheet will increase by A$1,108,610 and A$1,195,801 respectively (based on the facts at the date of the assessment),

 

   

there will be a reduction in the reported equity as the carrying amount of lease assets will reduce more quickly than the carrying amount of lease liabilities,

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

1.

BASIS OF PREPARATION AND ACCOUNTING POLICIES (CONTINUED)

 

b)

Changes in accounting policy (continued)

 

   

Loss for the period in the statement of profit or loss and other comprehensive income will be higher as the implicit interest in lease payments for former off-balance sheet leases will be presented as part of finance costs rather than being included in operating expenses,

 

   

operating cash outflows will be lower and financing cash flows will be higher in the statement of cash flows as principal repayments on all lease liabilities will now be included in financing activities rather than operating activities. Interest can also be included within financing activities.

 

c)

Going concern

These financial statements have been prepared on the basis of going concern, which contemplates the continuity of normal business activities and the realization of assets and settlement of liabilities in the ordinary course of business. During the half-year ended December 31, 2018, the Company has generated a loss for the period of A$15,579,391 (2017: A$7,250,597) and the Company has used cash in operations of A$10,458,479 (2017: A$7,875,025).

During the half-year ended December 31, 2018 and subsequent to that date, the Company completed a series of equity transactions totaling gross proceeds of A$45,014,900 which were used to fund operations. Of the total gross proceeds, A$28,073,761 was received in transactions completed during the half-year ended December 31, 2018, and A$16,961,139 was received in transactions completely subsequent to that date.

On June 6, 2018 the Company completed the first tranche of an institutional placement which included a second tranche totaling A$3.250 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on July 23, 2018, and the Company issued 65 million shares at a price of $0.050 per share and received gross proceeds of A$3,250,000 on July 26, 2018. On December 4, 2018 the Company completed the first tranche of an institutional placement of in which it issued 310,047,015 fully paid ordinary shares at a price of A$0.080 per share raising gross proceeds of A$24,803,761. The institutional placement included a second tranche totaling A$15.196 million of gross proceeds, contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on January 14, 2019, and subsequent to December 31, 2018 the Company issued 189,952,985 shares at a price of A$0.080 per share and received gross proceeds of A$15,196,239 on January 14, 2019. Also subsequent to December 31, 2018, on January 11, 2010 the Company completed a Share Purchase Plan under which it issued 22,061,250 shares of stock at a price of A$0.080 per share and received gross proceeds of A$1,764,900.

The Company benefits from cash inflows from the series of BARDA contracts, the first of which was awarded to the Company in September 2015. These payments from BARDA offset costs from various activities undertaken to support the FDA regulatory approval process for RECELL in the U.S., preparation for the planned commercial launch of RECELL in the U.S., and RECELL clinical programs in the U.S. With the U.S. FDA approval of RECELL for the treatment of burns in September 2018, and the U.S. market launch of the product in January 2019, sales of goods are expected to be an increasing source of revenue in the future. Another anticipated source of revenue for the Company is the BARDA contract line item covering the initial purchase, delivery and storage of the RECELL System in the amount of US$7,594,620 (~A$10m).

The Company expects to be utilizing cash reserves until U.S. and international sales of its products reach the level to fund ongoing operations. The Company has historically funded its research and development activities,

 

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Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

1.

BASIS OF PREPARATION AND ACCOUNTING POLICIES (CONTINUED)

 

c)

Going concern (continued)

 

and more recently its substantial investment in sales and marketing activities, through raising capital by issuing securities in the Company, and it is expected that similar funding will be obtained to provide working capital if and when required. If the Company is unable to raise capital in the future, the Company may need to curtail expenditures by scaling back certain research and development or other programs.

As a result of the above, the directors are satisfied that there is sufficient working capital to support the committed research and development programs and other activities over the next 12 months and the Company has the ability to realize its assets and pay its liabilities and commitments in the normal course of business. Accordingly, the directors have prepared the financial report on a going concern basis.

 

2.

REVENUE

 

     Half-year ended December 31,  
     2018      2017  

Revenue

     

Sale of goods

   A$ 1,813,195      A$ 607,761  
  

 

 

    

 

 

 
   A$ 1,813,195      A$ 607,761  
  

 

 

    

 

 

 

Other Income

     

BARDA income

   A$ 5,009,137      A$ 3,856,716  

Other income

     103,626        37,595  
  

 

 

    

 

 

 
   A$ 5,112,763      A$ 3,894,311  
  

 

 

    

 

 

 

 

3.

DIVIDENDS PAID OR PROVIDED FOR ON ORDINARY SHARES

No amounts have been paid, declared or recommended by Avita Medical Limited by way of dividend since the commencement of the half-year, and up to the date of this report.

 

4.

OPERATING SEGMENTS

The Company’s chief operating decision maker has been identified as the Chief Executive Officer.

The Chief Executive Officer reviews the financial and operating performance of the business primarily from a geographic perspective. On this basis, management have identified three reportable segments being the Asia Pacific, Europe and Americas including Canada. The Chief Executive Officer monitors the performance of all these segments separately. The Company does not operate in any other geographic segment.

The Chief Executive Officer assesses the performance of the operating segments based on a measure of gross margin and net profit before tax.

Unallocated

The following items of income and expense and associated assets are not allocated to operating segments as they are not considered part of the core operations of any segment:

 

   

Corporate revenue

 

   

Corporate charges

 

F-60


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

4.

OPERATING SEGMENTS (CONTINUED)

 

The segment information provided to the Chief Executive Officer for the reportable segments for the half-year ended December 31, 2018 is as follows:

 

     Continuing Operations        
     Asia Pacific     Europe      Americas     Total  

Half-year ended December 31, 2018

         

Revenue

         

Sales to external customers

   A$ 457,571     A$ 253,633      A$ 1,101,991     A$ 1,813,195  
  

 

 

   

 

 

    

 

 

   

 

 

 

Total revenue per statement of profit of loss and other comprehensive income

     457,571       253,633        1,101,991       1,813,195  
  

 

 

   

 

 

    

 

 

   

 

 

 

BARDA income and other income

     9,552       269        5,102,941       5,112,762  

Segment net loss before tax

   A$ (626,901   A$ (593,225)      A$ (11,948,943   A$ (13,169,069
  

 

 

   

 

 

    

 

 

   

Reconciliation of segment net result before tax to loss before income tax

         

Corporate charges

            (2,410,322
         

 

 

 

Loss before income tax

          A$ (15,579,391
         

 

 

 

Segment assets

         

Segment operating assets

   A$ 568,571     A$ 401,546      A$ 31,802,314       32,772,431  
  

 

 

   

 

 

    

 

 

   

Unallocated assets

            3,574,951  
         

 

 

 

Total assets per the statement of financial position

          A$ 36,347,382  
         

 

 

 

Segment liabilities

         

Segment operating liabilities

   A$ 169,516     A$ 151,248      A$ 4,591,266     A$ 4,912,030  
  

 

 

   

 

 

    

 

 

   

Unallocated liabilities

            188,068  
         

 

 

 

Total liabilities per the statement of financial position

          A$ 5,100,098  
         

 

 

 

 

F-61


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

4.

OPERATING SEGMENTS (CONTINUED)

 

     Continuing Operations        
     Asia Pacific     Europe     Americas     Total  

Half-year ended December 31, 2017

        

Revenue

        

Sales to external customers

   A$ 344,367     A$  263,394     A$ —       A$ 607,761  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue per statement of comprehensive income

     344,367       263,394       —         607,761  
  

 

 

   

 

 

   

 

 

   

 

 

 

BARDA income and other income

     34,151       3,224       3,856,936       3,894,311  

Segment net loss before tax

   A$ (688,840   A$ (1,325,927   A$ (3,098,175   A$ (5,112,942
  

 

 

   

 

 

   

 

 

   

Reconciliation of segment net result before tax to loss before income tax

        

Corporate charges

           (2,137,655
        

 

 

 

Loss before income tax

         A$ (7,250,597
        

 

 

 

Segment assets

        

Segment operating assets

   A$ 327,350     A$ 692,388     A$ 4,077,021     A$ 5,096,759  
  

 

 

   

 

 

   

 

 

   

Unallocated assets

           11,419,478  
        

 

 

 

Total assets per the statement of financial position

         A$ 16,516,237  
        

 

 

 

Segment liabilities

        

Segment operating liabilities

   A$ 119,882     A$ 192,630     A$ 1,526,727     A$ 1,839,239  
  

 

 

   

 

 

   

 

 

   

Unallocated liabilities

           153,693  
        

 

 

 

Total liabilities per the statement of financial position

         A$ 1,992,932  
        

 

 

 

 

4.

COMMITMENTS AND CONTINGENCIES

There are no significant changes to the commitments and contingencies disclosed in the most recent annual financial report.

 

5.

CONTRIBUTED EQUITY

 

     As of Dec 31, 2018      As of Jun 30, 2018  

Ordinary shares

     

Issued and fully paid

   A$ 188,210,306      A$ 162,801,028  
  

 

 

    

 

 

 

 

     Number      A$  

Movement in ordinary shares on issue:

     

At July 1, 2018

     1,277,378,325      A$ 162,801,028  

Issue of shares

     375,047,015        28,098,701  

Capital raising costs

     —          (2,689,423
  

 

 

    

 

 

 

At December 31, 2018

     1,652,425,340      A$ 188,210,306  
  

 

 

    

 

 

 

 

F-62


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

5.

CONTRIBUTED EQUITY (CONTINUED)

 

(a)

Recognized share-based payment expenses

The expense recognized for employee services received during the half-year is shown in the table below:

 

     Half-year ended December 31,  
     2018      2017  

Expenses arising from equity-settled share-based payment transactions

   A$ 1,043,694      A$ 726,855  
  

 

 

    

 

 

 

Total expense arising from share-based payment transactions

   A$ 1,043,694      A$ 726,855  
  

 

 

    

 

 

 

 

(b)

Option pricing model: ESOP and Investor

Equity-settled transactions

The fair value of the equity-settled share options granted under the ESOP is estimated at the date of grant using a Binomial Model taking into account the terms and conditions upon which the options were granted.

The options issued in the period have vesting criteria based on the following performance conditions:

 

   

Tenure with the Company

 

   

Revenue target

 

   

FDA PMA approval of RECELL for burns

 

   

Initial BARDA procurement under CLIN2 of the BARDA Contract

 

   

US Quotation

i) On November 1, 2018, 2,000,000 options were granted to employee at an exercise price of A$0.056 expiring on November 1, 2028.

The following table lists the inputs to the models used for the options granted to employee each year:

 

Grant date

     11/1/2018  

Share price at date of grant

   A$ 0.093  

Dividend yield (%)

     0

Expected volatility (%)

     90

Risk-free interest rate (%)

     2.65

Expected life of option (days)

     3,650  

Option exercise price (A$)

   A$ 0.056  

This represents tranches 2, 12-15, the fair value at date of grant for each tranche is as follows:

 

Tranche 2

   A$ 0.0834  

Tranche 12

   A$ 0.0607  

Tranche 13

   A$ 0.0673  

Tranche 14

   A$ 0.0715  

Tranche 15

   A$ 0.0748  

 

F-63


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

5.

CONTRIBUTED EQUITY (CONTINUED)

 

(b)

Option pricing model: ESOP and Investor (continued)

 

ii) On November 1, 2018, 12,700,000 options were granted to employees at an exercise price of A$0.057 expiring on November 1, 2028.

The following table lists the inputs to the models used for the options granted to employees:

 

Grant date

     11/1/2018  

Share price at date of grant

   A$ 0.093  

Dividend yield (%)

     0

Expected volatility (%)

     90

Risk-free interest rate (%)

     2.65

Expected life of option (days)

     3,650  

Option exercise price (A$)

   A$ 0.057  

This represents tranches 1, 4-11, 16-19, the fair value at date of grant for each tranche is as follows:

 

Tranche 1

   A$ 0.0834      Tranche 10    A$ 0.0709  

Tranche 4

   A$ 0.0593      Tranche 11    A$ 0.0742  

Tranche 5

   A$ 0.0662      Tranche 16    A$ 0.0607  

Tranche 6

   A$ 0.0709      Tranche 17    A$ 0.0671  

Tranche 7

   A$ 0.0742      Tranche 18    A$ 0.0714  

Tranche 8

   A$ 0.0593      Tranche 19    A$ 0.0747  

Tranche 9

   A$ 0.0662        

iii) On November 1, 2018, 3,000,000 options were granted to employees at an exercise price of A$0.059 expiring on November 1, 2028.

The following table lists the inputs to the models used for the options granted to employees:

 

Grant date

     11/1/2018  

Share price at date of grant

   A$ 0.093  

Dividend yield (%)

     0

Expected volatility (%)

     90

Risk-free interest rate (%)

     2.65

Expected life of option (days)

     3,650  

Option exercise price (A$)

   A$ 0.059  

This represents tranches 3, 20-23, the fair value at date of grant for each tranche is as follows:

 

Tranche 3

   A$ 0.0831  

Tranche 20

   A$ 0.0604  

Tranche 21

   A$ 0.0669  

Tranche 22

   A$ 0.0712  

Tranche 23

   A$ 0.0744  

iv) On November 1, 2018, 17,200,000 options were granted to employees at an exercise price of A$0.089 expiring on November 1, 2028.

 

F-64


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

5.

CONTRIBUTED EQUITY (CONTINUED)

 

(b)

Option pricing model: ESOP and Investor (continued)

 

The following table lists the inputs to the models used for the options granted to employees.

 

     Tranche 1     Tranche 2     Tranche 3     Tranche 4  

Grant date

     11/1/2018       11/1/2018       11/1/2018       11/1/2018  

Share price at date of grant

   A$ 0.093     A$ 0.093     A$ 0.093     A$ 0.093  

Dividend yield (%)

     0     0     0     0

Expected volatility (%)

     90     90     90     90

Risk-free interest rate (%)

     2.65     2.65     2.65     2.65

Expected life of option (days)

     3,650       3,650       3,650       3,650  

Fair value at date of grant

   A$ 0.0587     A$ 0.0641     A$ 0683     A$ 0.0716  

Option exercise price (A$)

   A$ 0.089     A$ 0.089     A$ 0.089     A$ 0.089  

v) On November 30, 2018, 24,851,250 options were granted to employees at an exercise price of A$0.082 expiring on November 30, 2028.

The following table lists the inputs to the models used for the options granted to employees.

 

     Tranche 1     Tranche 2     Tranche 3     Tranche 4  

Grant date

     11/1/2018       11/1/2018       11/1/2018       11/1/2018  

Share price at date of grant

   A$ 0.082     A$ 0.082     A$ 0.082     A$ 0.082  

Dividend yield (%)

     0     0     0     0

Expected volatility (%)

     90     90     90     90

Risk-free interest rate (%)

     2.65     2.65     2.65     2.65

Expected life of option (days)

     3,650       3,650       3,650       3,650  

Fair value at date of grant

   A$ 0.0514     A$ 0.0561     A$ 0.0599     A$ 0.0628  

Option exercise price (A$)

   A$ 0.082     A$ 0.082     A$ 0.082     A$ 0.082  

vi) On November 30, 2018, 15,000,000 options were granted to Dr. Michael Perry at an exercise price of A$0.082 expiring on November 20, 2028 based on the following milestones:

 

  1.

Tenure – a total of 7,499,999 options issued for immediate vesting and over the two-year period commencing July 1, 2017;

 

  2.

Company Share Price – a total of 5,000,001 options issued but to vest in three equal tranches subject to the Volume Weighted Average Price (VWAP) of Company share price (as at close of trade on the ASX on relevant date) achieving multiples of 2x, 3x and 4x the Company’s share price at the time of shareholder approval; and

 

F-65


Table of Contents

AVITA MEDICAL LIMITED

NOTES TO THE HALF-YEAR CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(IN AUSTRALIAN DOLLARS)

(UNAUDITED)

 

5.

CONTRIBUTED EQUITY (CONTINUED)

 

(b)

Option pricing model: ESOP and Investor (continued)

 

  3.

Milestone performance – a total of 2,500,000 options issued, but to vest upon the achievement of initial BARDA procurement under CLIN2 of the BARDA Contract.

 

     Tranche 1     Tranche 2     Tranche 3     Tranche 4  

Grant date

     11/30/2018       11/30/2018       11/30/2018       11/30/2018  

Share price at date of grant

   A$ 0.082     A$ 0.082     A$ 0.082     A$ 0.082  

Dividend yield (%)

     0     0     0     0

Expected volatility (%)

     90     90     90     90

Risk-free interest rate (%)

     2.59     2.59     2.59     2.59

Expected life of option (days)

     3,650       3,650       3,650       3,650  

Fair value at date of grant

   A$ 0.049     A$ 0.054     A$ 0.048     A$ 0.052  

Option exercise price (A$)

   A$ 0.082     A$ 0.082     A$ 0.082     A$ 0.082  

 

     Tranche 5     Tranche 6     Tranche 7        

Grant date

     11/30/2018       11/30/2018       11/30/2018    

Share price at date of grant

   A$ 0.082     A$ 0.082     A$ 0.082    

Dividend yield (%)

     0     0     0  

Expected volatility (%)

     90     90     90  

Risk-free interest rate (%)

     2.59     2.59     2.59  

Expected life of option (days)

     3,650       3,650       3,650    

Fair value at date of grant

   A$ 0.058     A$ 0.071     A$ 0.048    

Option exercise price (A$)

   A$ 0.082     A$ 0.082     A$ 0.082    

 

7.

RELATED PARTY DISCLOSURES

The total amount of transactions entered into with Key Management Personnel for the half-year ended December 31, 2018 were A$51,802 Consultancy fees (2017: A$124,156) paid under normal terms and conditions to Bioscience Managers Pty Ltd of which Mr. Curnock Cook is an officer and Dr. Michael Perry is a director.

Details of all related party transactions have been disclosed in the annual report for the year ended 30 June 2018. There have been no new significant related party transactions during the interim period.

 

8.

SUBSEQUENT EVENTS

During the six months ended December 31, 2018, the Company completed an institutional placement of shares to institutional placements of shares to U.S., Australian and international institutional and sophisticated investors. The institutional placement included a second tranche contingent upon shareholder approval. Shareholder approval for Tranche 2 was received at an Extraordinary General Meeting held on January 14, 2019, and subsequent to December 31, 2018 the Company issued 189,952,985 shares at a price of A$0.080 per share and received gross proceeds of A$15,196,239 on January 14, 2019. Also subsequent to December 31, 2018, on January 11, 2019 the Company completed a Share Purchase Plan under which it issued 22,061,250 shares of stock at a price of A$0.080 per share and received gross proceeds of A$1,764,900.

 

F-66

EX-1.1

Exhibit 1.1

CORPORATIONS ACT

CONSTITUTION

of

AVITA MEDICAL LIMITED

ACN 058 466 523


TABLE OF CONTENTS

 

1.

   Definitions and interpretation      1  

2.

   Rights      3  

3.

   Issue of Shares      3  

4.

   Commission and brokerage      4  

5.

   Trusts not recognised      4  

6.

   Joint holders      4  

7.

   Share certificates      4  

8.

   Non-Marketable Parcels      5  

9.

   General      7  

10.

   Instalments and amounts which become payable      7  

11.

   Interest and expenses      8  

12.

   Recovery of amounts due      8  

13.

   Differentiation      8  

14.

   Payment of calls in advance      8  

15.

   Lien      9  

16.

   Lien sale      10  

17.

   Forfeiture notice      10  

18.

   Forfeiture      11  

19.

   Liability of former Member      11  

20.

   Disposal of forfeited Shares      12  

21.

   General      12  

22.

   Transfer procedure      13  

23.

   Right to refuse registration      14  

24.

   Title on death      15  

25.

   Entitlement to transmission      15  

26.

   Consolidation or subdivision      16  


Exhibit 1.1

 

27.

   Powers of attorney      16  

28.

   Convening      16  

29.

   Notice      17  

30.

   Business      17  

31.

   Member      18  

32.

   Quorum      18  

33.

   Chairperson      18  

34.

   General conduct      19  

35.

   Adjournment      19  

36.

   Decisions      19  

37.

   Taking a poll      20  

38.

   Casting vote of chairperson      20  

39.

   Offensive material      20  

40.

   Auditor’s right to be heard      21  

41.

   Entitlement to vote      21  

42.

   Unpaid calls      22  

43.

   Joint holders      22  

44.

   Objections and Listing Rules      22  

45.

   Votes by proxy      23  

46.

   Instrument appointing proxy      23  

47.

   Proxy in blank      24  

48.

   Lodgment of proxy      24  

49.

   Validity      24  

50.

   Representatives of corporations      25  

51.

   Number of Directors      25  

52.

   Qualification      25  

53.

   Power to remove and appoint      25  


Exhibit 1.1

 

54.

   Additional and casual Directors      26  

55.

   Filling vacated office      26  

56.

   Retirement by rotation      26  

57.

   Nomination of Director      27  

58.

   Vacation of office      27  

59.

   Remuneration of Non-Executive Directors      28  

60.

   Remuneration of Executive Directors      29  

61.

   Benefit to retiring Directors      29  

62.

   Directors to manage company      29  

63.

   Directors’ meetings      30  

64.

   Decisions      31  

65.

   Directors’ interests      31  

66.

   Alternate Directors      32  

67.

   Remaining Directors      32  

68.

   Chairperson      32  

69.

   Directors’ committees      33  

70.

   Written resolutions      33  

71.

   Validity of acts of Directors      34  

72.

   Minutes      34  

73.

   Appointment      34  

74.

   Powers of Executive Directors      35  

75.

   Secretary      35  

76.

   Common seal      36  

77.

   Duplicate seal      36  

78.

   Certificate seal      36  

79.

   Times for inspection      36  

80.

   Dividends Generally      37  


Exhibit 1.1

 

81.

   Interim & Final Dividends      37  

82.

   Permitted Dividends      37  

83.

   No Interest      37  

84.

   Reserves      37  

85.

   Alternative Method of Payment of Dividend      38  

86.

   Payment of Dividends      38  

87.

   Unclaimed Dividends      38  

88.

   Breach of Restriction Agreement      39  

89.

   Election to reinvest dividend      39  

90.

   Capitalisation of profits      39  

91.

   Service of notices      39  

92.

   Persons entitled to notice      41  

93.

   Company to keep financial records      41  

94.

   Winding up      41  

95.

   Indemnity      42  

96.

   Listing Rules      43  

97.

   ASTC Settlement Rules      43  

98.

   Formalities Omitted      43  


CORPORATIONS ACT

COMPANY LIMITED BY SHARES

CONSTITUTION

OF

AVITA MEDICAL LIMITED

PRELIMINARY

 

1.

Definitions and interpretation

 

1.1

In this Constitution:

ASTC’ means ASX Settlement and Transfer Corporation Pty Ltd (ABN 49 008 504 532);

ASTC Settlement Rules’ means the settlement rules of ASTC as amended from time to time;

Alternate Director’ means a person appointed as an alternate director under clause 66;

Auditor’ means the Company’s auditor;

Business Day’ has the same meaning as in the Listing Rules;

CHESS’ has same meaning as that term has in the ASTC Settlement Rules;

CHESS approved’ has the same meaning as that term has in the Listing Rules;

Company’ means Avita Medical Limited ACN 058 466 523;

Constitution’ means the constitution of the Company as amended from time to time;

Corporations Act’ means the Corporations Act 2001 (Cth);

Corporations Regulations’ means the Corporations Regulations 2001 (Cth);

Director’ means a person appointed to and acting in the position of a director of the Company;

Directors’ means all or some of the Directors acting as a board;

dividend’ includes bonus;


Exchange’ means ASX Limited (ABN 98 008 624 961) and, where the context requires, the Australian Securities Exchange operated by ASX Limited, and includes any body corporate succeeding to all or most of the powers, functions and duties of ASX Limited;

Executive Director’ means a person appointed or holding office as an executive director under clause 73.1;

Listing Rules’ means the Listing Rules of the Exchange in force from time to time;

Managing Director’ means a Director appointed as managing director under clause 73.1;

Marketable Parcel’ has the same meaning as in the ASTC Settlement Rules;

Member’ means a person whose name is entered for the time being on the Register as the holder of one or more Shares;

Non-Executive Director’ means a Director who is not an Executive Director;

Non-Marketable Parcel’ means a parcel of securities which is less than a Marketable Parcel;

Office’ means the Company’s registered office;

proper ASTC transfer’ has the same meaning as that term has in the Corporations Regulations;

PDF Act’ means the Pooled Development Funds Act 1992 (Cth);

Register’ means the register of Members of the Company;

Registered Address’ means the last known address of a Member as noted in the Register;

Representative’ means a person appointed by a Member to act as its representative under clause 50.1 or under section 250D of the Corporations Act;

Restricted Securities’ has the same meaning as in the Listing Rules;

Seal’ means the Company’s common seal (if any);

Secretary’ means any person appointed by the Directors to perform any of the duties of a secretary of the Company and if there are joint secretaries, any one or more of such joint secretaries;

Shares’ means ordinary shares in the share capital of the Company; and

Uncertificated Holding’ means a holding of Shares which is not held on any certificated subregister maintained by or on behalf of the Company.

 

2


1.2

In this Constitution, unless the contrary intention appears:

 

  (a)

the singular includes the plural and vice versa and words importing a gender include other genders;

 

  (b)

words importing natural persons include corporations;

 

  (c)

words and expressions defined in the Corporations Act have the same meaning in this Constitution;

 

  (d)

headings are for ease of reference only and do not affect the construction of this Constitution; and

 

  (e)

a reference to the Corporations Act or the PDF Act is a reference to that legislation as modified or amended from time to time.

 

1.3

Unless the contrary intention appears in this Constitution, an expression in a clause of this Constitution has the same meaning as in a provision of the Corporations Act which deals with the same matter as the clause.

 

1.4

To the extent permitted by law, the replaceable rules contained in the Corporations Act do not apply to the Company.

SHARES

 

2.

Rights

 

2.1

Subject to this Constitution and to the terms of issue of Shares, all Shares attract the right:

 

  (a)

to receive notice of and to attend and vote at all general meetings of the Company;

 

  (b)

to receive dividends; and

 

  (c)

in a winding up to participate equally in the distribution of the assets of the Company (both capital and surplus), subject only to any amounts unpaid on the Share.

 

2.2

The Directors must not issue or allot a Share or a unit of a Share if the rights attached to the Share would be different from the rights attached to Shares then on issue.

 

3.

Issue of Shares

 

3.1

Subject to the Corporations Act, the PDF Act, the Listing Rules and this Constitution, the Directors may issue or dispose of Shares to persons:

 

3


  (a)

on terms determined by the Directors;

 

  (b)

at the issue price that the Directors determine; and

 

  (c)

at the time that the Directors determine.

 

3.2

The Directors’ power under clause 3.1 includes the power to grant options to have Shares issued.

 

3.3

For the avoidance of doubt, the Directors must not issue or allot a share (or a unit of a share) unless it is a Share and must not divide Shares into classes.

 

4.

Commission and brokerage

Any brokerage or commission which may be paid by the Company may be made in cash, by the issue of Shares, or the issue of debentures, or by a combination of any of those methods.

 

5.

Trusts not recognised

 

5.1

Except as required by law, the ASTC Settlement Rules or as otherwise provided by this Constitution, the Company will not recognise any person as holding a Share on trust and the Company will not be bound to recognise any equitable, contingent, future or partial interest or any other right in respect of a Share except the registered holder’s absolute right of ownership.

 

5.2

This clause 5 applies even if the Company has notice of the relevant trust, interest or right.

 

6.

Joint holders

 

6.1

If two or more persons are registered as the holders of a Share, they are taken to hold the Share as joint tenants with benefit of survivorship and the person whose name appears first on the Register is the only joint holder entitled to receive notices from the Company.

 

6.2

Any one of the joint holders of a Share may give an effective receipt for any dividend or return of capital payable to the joint holders.

 

7.

Share certificates

 

7.1

The Directors may in their absolute discretion issue a certificate to a Member for all Shares registered in its name. Members have no right, however, to receive a certificate for Shares.

 

7.2

Any certificate for Shares must be issued and despatched in accordance with the Corporations Act, the ASTC Settlement Rules and the Listing Rules.

 

4


7.3

The Directors may in their absolute discretion elect whether to maintain a certificated subregister for any class of Shares.

 

7.4

Subject to the Listing Rules and the ASTC Settlement Rules, Shares may be held on any subregister maintained by or on behalf of the Company.

 

7.5

The Directors may order worn out or defaced certificates to be cancelled and, if necessary, replaced by new certificates.

 

8.

Non-Marketable Parcels

 

8.1 (a)

If at any time the number of Shares registered in the name of a Member is less than a Marketable Parcel and those Shares are held on a certificated subregister or an issuer sponsored subregister (‘Eligible Member’), the Directors may cause a written notice (‘Notice’) to be despatched to the Eligible Member, requiring the Eligible Member to advise the Company by a specified date (‘Relevant Date’) whether the Eligible Member elects that the provisions of this clause are not to apply to the Shares.

 

  (b)

The Relevant Date must be not less than six weeks after the date of service of the Notice.

 

8.2 (a)

At least four weeks before the Notice being despatched the Directors may cause a notice to be despatched to each Member who holds an Uncertificated Holding which is less than a Marketable Parcel, advising each of those Members of the Directors’ intention to invoke the procedure provided for in this clause 8 (‘Procedure’).

 

  (b)

That notice must state that if the Member wishes to have its holding sold in accordance with the Procedure it will be necessary for that Member to effect or arrange for conversion of its holding to the certificated subregister before a specified date, being the date on which the Directors intend to invoke the Procedure.

 

8.3

At the time the Procedure is invoked a Notice must be despatched to each and every Eligible Member.

 

8.4

The Notice must state that the Shares referred to in the Notice will be liable to be sold unless, by the Relevant Date:

 

  (a)

the Member advises the Company that the provisions of this clause are not to apply to the Shares; or

 

  (b)

the Member’s holding is no longer on the certificated subregister.

 

8.5

Every Eligible Member on which a Notice has been served may by notice in writing to the Company and delivered to the Office before the Relevant Date require the Company not to sell that Member’s Shares in accordance with this clause in which event no sale of that Member’s Shares will take place.

 

5


8.6

If the Eligible Member does not advise the Company by the Relevant Date that the provisions of this clause are not to apply to the Shares referred to in the Notice, any of those Shares which are held on the certificated subregister as at the Relevant Date may be sold by the Company.

 

8.7

Any Shares which may be sold pursuant to this clause may be sold on the terms, in the manner and at the time determined by the Directors and for the purposes of a sale pursuant to this clause each Eligible Member:

 

  (a)

appoints the Company the Eligible Member’s agent for sale;

 

  (b)

authorises the Company to effect on the Eligible Member’s behalf a transfer of the Shares sold;

 

  (c)

appoints the Company and its Directors jointly and severally as the Eligible Member’s attorneys in the Eligible Member’s name and on the Eligible Member’s behalf to execute any instrument or take any other steps as they or any of them may consider appropriate to transfer the Shares sold.

 

8.8

The title of the transferee to Shares acquired pursuant to this clause is not affected by any irregularity or invalidity in connection with the sale of Shares to the transferee.

 

8.9 (a)

The proceeds of any sale of Shares pursuant to this clause less any unpaid calls and interest (‘Sale Consideration’) will be paid to the relevant Member or as that Member may direct.

 

  (b)

The Sale Consideration received by the Company in respect of all Shares sold pursuant to this clause will be paid into a bank account opened and maintained by the Company for the purposes of this clause.

 

  (c)

The Company will hold the Sale Consideration in trust for the Member whose Shares are sold pursuant to this clause and will forthwith notify the Member in writing that the Sale Consideration in respect of the Member’s Shares has been received by the Company and is being held by the Company pending instructions from the Member as to how it is to be dealt with. Unless the Member has waived any entitlement it may have to a share certificate or certificates, the Member’s instructions, to be effective, must be accompanied by the share certificate or certificates to which the Sale Consideration relates or, if the certificate or certificates has or have been lost or destroyed, by a statement and undertaking to that effect.

 

6


8.10

Subject to the Corporations Act, the Company or the purchaser will bear all costs, including brokerage and stamp duty, associated with the sale of any Shares pursuant to this clause.

 

8.11

The Procedure may only be invoked once in any 12 month period after its adoption or renewal.

 

8.12

If the Procedure has been invoked and there is an announcement of a takeover offer or takeover announcement for Shares, no more sales of Shares may be made pursuant to this clause 8 until after the close of the offers made under the takeover offer or takeover announcement. The Procedure may then be invoked again.

CALLS

 

9.

General

 

9.1

Subject to the terms on which partly paid Shares are issued, the Directors may make calls on the holders of the Shares for any money unpaid on them.

 

9.2

A call is made when the resolution of the Directors authorising it is passed. The Directors may require it to be paid by instalments, and may revoke or postpone the call after it has been made.

 

9.3

The Company must comply with the Listing Rules in relation to the dispatch and content of notices to Members on whom a call is made.

 

9.4

A Member to whom notice of a call is given in accordance with this clause 9 must pay to the Company the amount called in accordance with the notice.

 

9.5

Failure to send a notice of a call to any Member or the non-receipt of a notice by any Member does not invalidate the call.

 

9.6

Joint holders of Shares are jointly and severally liable to pay all calls in respect of their Shares.

 

10.

Instalments and amounts which become payable

If:

 

  (a)

the Directors require a call to be paid by instalments; or

 

  (b)

an amount becomes payable by the terms of issue of Shares on allotment, or at a time or in circumstances specified in the terms of issue,

then:

 

  (c)

the amount is payable as if it were a call made by the Directors and as if they had given notice of it; and

 

7


  (d)

the consequences of late payment or non-payment of the amount are the same as the consequences of late payment or non-payment of a call.

 

11.

Interest and expenses

If an amount called is not paid on or before the due date, the person liable to pay the amount must also pay:

 

  (a)

interest on the amount from the due date to the time of actual payment at a rate determined by the Directors (not exceeding 20% per annum); and

 

  (b)

all expenses incurred by the Company as a consequence of the non-payment,

but the Directors may waive payment of the interest and expenses in whole or in part.

 

12.

Recovery of amounts due

On the hearing of any action for the recovery of money due for any call, proof that:

 

  (a)

the name of the person sued was, when the call was made, entered in the Register as a holder or the holder of Shares in respect of which the call was made;

 

  (b)

the resolution making the call is duly recorded in the Directors’ minute book; and

 

  (c)

notice of the call was given to the person sued,

will be conclusive evidence of the debt.

 

13.

Differentiation

The Directors may, on the issue of Shares, differentiate between the holders as to the amount of calls to be paid and the times of payment.

 

14.

Payment of calls in advance

 

14.1

The Directors may accept from a Member the whole or part of the amount unpaid on a Share before the amount accepted has been called.

 

14.2

The Company may:

 

  (a)

pay interest on any amount accepted, until the amount is payable under a call and at a rate (not exceeding 20% per annum) agreed between the Member and the Directors; and

 

  (b)

subject to any contract between the Company and the Member, repay all or any of the amount accepted in excess of the amount called on the Share.

 

8


14.3

Payment of an amount in advance of a call does not entitle the paying Member to any dividend, benefit or advantage, other than the payment of interest under this clause 14, to which the Member would not have been entitled if it had paid the amount when it became due.

LIEN AND FORFEITURE

 

15.

Lien

 

15.1

To the extent permitted by the Listing Rules, the Company has a first and paramount lien on every partly paid Share and dividends payable in respect of the Share for all money:

 

  (a)

due and unpaid to the Company at a fixed time, in respect of the Share;

 

  (b)

presently payable by a holder or the holder of the Share, or the holder’s estate, to the Company in respect of the Share; or

 

  (c)

which the Company is required by law to pay (and has paid) in respect of the Share.

 

15.2

The lien extends to reasonable interest and expenses incurred because the amount is not paid.

 

15.3

If any law for the time being of any country, state or place imposes or purports to impose an immediate or contingent liability on the Company to make any payment or authorises a taxing authority or Government official to require the Company to make payment in respect of Shares or dividends or other moneys accruing due to the Member who holds the Shares:

 

  (a)

the Member or, if the Member is deceased, the Member’s legal personal representative, indemnifies the Company in respect of any such payment or liability; and

 

  (b)

subject to the Listing Rules, the Company:

 

  (i)

has a lien on the Shares and dividends and other moneys payable in respect of the Shares, whether the Shares are held by the Member solely or jointly with any other person or by that Member’s legal personal representative, in respect of any payment made or liability incurred by the Company, together with reasonable interest on any payment made by the Company at a rate to be fixed by the Directors not exceeding 20% per annum from the date of payment by the Company to the date of repayment by the Member;

 

  (ii)

may set off amounts so paid by the Company against amounts payable by the Company to the Member as dividends or otherwise; and

 

9


  (iii)

may recover as a debt due from the Member or its legal personal representative the amount of all payments made by the Company together with interest at the rate and for the period referred to in clause 15.3(b)(i).

 

15.4

The Company may do all things which the Directors think necessary or appropriate to do under the ASTC Settlement Rules and the Listing Rules to enforce or protect the Company’s lien.

 

15.5

Unless the Directors determine otherwise, the registration of a transfer of a Share operates as a waiver of the Company’s lien on the Share.

 

15.6

The Directors may declare a Share to be wholly or partly exempt from a lien.

 

16.

Lien sale

If:

 

  (a)

the Company has a lien on a Share for money presently payable;

 

  (b)

the Company has given the Member or the Member’s executors or administrators (as the case may be) holding the Share written notice demanding payment of the money; and

 

  (c)

that Member fails to pay all of the money demanded,

then 14 or more days after giving the notice, the Directors may, if the Listing Rules permit, sell the Share in any manner determined by them.

 

17.

Forfeiture notice

 

17.1

The Directors may at any time after a call or instalment becomes payable and remains unpaid by a Member, serve a notice on the Member requiring the Member to pay:

 

  (a)

the unpaid amount;

 

  (b)

any interest that has accrued; and

 

  (c)

all expenses incurred by the Company as a consequence of the non-payment.

 

17.2

The notice under clause 17.1 must:

 

  (a)

specify a day (not earlier than 14 days after the date of the notice) on or before which the payment required by the notice must be made; and

 

  (b)

state that if a Member does not comply with the notice, the Shares in respect of which the call was made or instalment is payable will be liable to be forfeited.

 

10


18.

Forfeiture

 

18.1

If a Member does not comply with a notice served under clause 17, then any or all of the Shares in respect of which the notice was given may be forfeited pursuant to a resolution of the Directors.

 

18.2

Unpaid dividends in respect of forfeited Shares will also be forfeited.

 

18.3

On forfeiture, Shares become the property of the Company and forfeited Shares must be:

 

  (a)

disposed of, or cancelled (subject to the Listing Rules) on terms determined by the Directors; or

 

  (b)

offered by public auction in accordance with any requirements of the Listing Rules.

 

18.4

The Directors may, at any time before a forfeited Share is sold, disposed of or cancelled, annul the forfeiture of the Share on conditions determined by them.

 

18.5

Promptly after a Share has been forfeited:

 

  (a)

notice of the forfeiture must be given to the Member in whose name the Share was registered immediately before its forfeiture; and

 

  (b)

the forfeiture and its date must be noted in the Register.

 

18.6

Omission or neglect to give notice of or to note the forfeiture as specified in clause 18.5 will not invalidate a forfeiture.

 

19.

Liability of former Member

 

19.1

The interest of a person who held Shares which are forfeited is extinguished but subject to the Listing Rules, the former Member remains liable to pay:

 

  (a)

all money (including interest and expenses) that was payable by the Member to the Company at the date of forfeiture in respect of the forfeited Shares; and

 

  (b)

interest from the date of forfeiture until payment at a rate determined by the Directors (not exceeding 20% per annum).

 

19.2

A former Member’s liability to the Company ceases if and when the Company receives payment in full of all money (including interest and expenses) payable by the person in respect of the Shares. The liability may only be released or waived in accordance with the Listing Rules.

 

11


20.

Disposal of forfeited Shares

 

20.1

The Company may:

 

  (a)

receive the consideration (if any) given for a forfeited Share on any sale or disposition of the Share; and

 

  (b)

effect a transfer of the Share in favour of a person to whom the Share is sold or disposed of.

 

20.2

The purchaser of the Share:

 

  (a)

is not bound to check the regularity of the sale or the application of the purchase price;

 

  (b)

obtains title to the Share despite any irregularity in the sale; and

 

  (c)

will not be subject to complaint or remedy by the former holder of the Share in respect of the purchase.

 

20.3

A statement signed by a Director and the Secretary that the Share has been regularly forfeited and sold or reissued or regularly sold without forfeiture to enforce a lien, is conclusive evidence of the matters stated as against all persons claiming to be entitled to the Share.

 

20.4

The net proceeds of any sale made to enforce a lien or on forfeiture must be applied by the Company in the following order:

 

  (a)

in payment of the costs of the sale;

 

  (b)

in payment of all amounts secured by the lien or all money that was payable in respect of the forfeited Share; and

 

  (c)

in payment of any surplus to the former Member whose Share was sold.

TRANSFER OF SHARES

 

21.

General

 

21.1

Subject to this Constitution, a Member may transfer Shares held by that Member.

 

21.2

Subject to clause 21.3, Shares may be transferred by:

 

  (a)

a written transfer instrument in any usual or common form; or

 

  (b)

any other form approved by the Directors.

 

12


21.3 (a)

At the discretion of the Directors, the Company may participate in any computerised or electronic system for market settlement, securities transfer and registration conducted in accordance with the Corporations Act, the Listing Rules and the ASTC Settlement Rules.

 

  (b)

If the Company participates in a system of the kind described in clause 21.3(a), then despite any other provision of this Constitution:

 

  (i)

Shares may be transferred, and transfers may be registered, in any manner required or permitted by the Listing Rules or the ASTC Settlement Rules applying in relation to the system;

 

  (ii)

the Company must comply with and give effect to those rules; and

 

  (iii)

the Company may, in accordance with those rules, decline to issue certificates for holdings of Shares.

 

21.4

A written transfer instrument must be:

 

  (a)

executed by the transferor or (where the Corporations Act permits) stamped by the transferor’s broker;

 

  (b)

unless the Directors decide otherwise in the case of a fully paid Share, executed by the transferee or (where the Corporations Act permits) stamped by the transferee’s broker; and

 

  (c)

in the case of a transfer of partly paid Shares, endorsed or accompanied by an instrument executed by the transferee or by the transferee’s broker to the effect that the transferee agrees to accept the Shares subject to the terms and conditions on which the transferor held them, to become a Member and to be bound by the Constitution.

Subject to the Corporations Act, the written transfer instrument may comprise two documents.

 

21.5

Except in the case of a proper ASTC transfer:

 

  (a)

a transferor of Shares remains the holder of the Shares transferred until the transfer is registered and the name of the transferee is entered in the Register in respect of the Shares;

 

  (b)

a transfer of Shares does not pass the right to any dividends on the Shares until such registration.

 

22.

Transfer procedure

 

22.1

For a transfer of Shares that is not an ASTC-regulated transfer:

 

13


  (a)

the written transfer instrument must be left at the Office or another place acceptable to the Company;

 

  (b)

the instrument must be accompanied by a certificate for the Shares dealt with in the transfer where a certificate has been issued, unless the Directors waive production of the certificate on receiving satisfactory evidence of the loss or destruction of the certificate; and

 

  (c)

the Directors may require other evidence of the transferor’s right to transfer the Shares.

 

22.2

For a transfer of a Shares that is an ASTC-regulated transfer a Share transfer must be effected in accordance with the applicable Listing Rules and ASTC Settlement Rules.

 

23.

Right to refuse registration

 

23.1

The Directors may in their absolute discretion refuse to register any transfer of Shares or other securities in any circumstances permitted by the Listing Rules.

 

23.2

The Directors must:

 

  (a)

refuse to register any transfer of Shares where the transfer would result in a breach by any person of the PDF Act, if refusal is permitted under the Listing Rules;

 

  (b)

refuse to register any transfer of Shares or other securities which are Restricted Securities during the escrow period except as permitted by the Listing Rules or the Exchange; and

 

  (c)

refuse to register any transfer where the Company is, or the Directors are, required to do so by the Listing Rules.

 

23.3

Despite clauses 23.1 and 23.2, the Company must not refuse or fail to register or give effect to, or delay or in any way interfere with, a proper ASTC transfer of Shares or other securities.

 

23.4

If a person has lodged a transfer which the Directors have refused to register, the Company must, within 5 Business Days after the date of lodgment, give to the lodging person written notice of the refusal and the reasons for it.

 

23.5

Subject to clause 23.3, Restricted Securities cannot be disposed of during the escrow period except as permitted by the Listing Rules or the Exchange. The Company will refuse to acknowledge a disposal of Restricted Securities to the extent required under the Listing Rules.

 

14


TRANSMISSION OF SHARES

 

24.

Title on death

 

24.1

The legal personal representative of a deceased Member who was the sole holder of Shares is the only person whom the Company will recognise as having any title to the deceased Member’s Shares.

 

24.2

If a deceased Member was a joint holder of Shares, the other joint holder is the only person whom the Company will recognise as having any title to the deceased Member’s Shares.

 

24.3

The estate of the deceased Member will not be released from any liability to the Company in respect of the Shares.

 

24.4

The Company may register or give effect to a transfer to a transferee who dies before the transfer is registered.

 

25.

Entitlement to transmission

 

25.1

A person who becomes entitled to a Share in consequence of the death, mental illness or bankruptcy of a Member may, subject to clause 22 and to producing to the Company evidence of its entitlement which is satisfactory to the Directors, elect to:

 

  (a)

be registered as the holder of the Share; or

 

  (b)

transfer the Share to some other person nominated by it.

 

25.2

If the person who has become entitled to a Share:

 

  (a)

elects to be registered as the holder, then the person must deliver or send to the Company a written notice of election signed by him or her; or

 

  (b)

elects to transfer the Share, then the person must effect a transfer of the Share.

 

25.3

An election to be registered as a holder of a Share under clause 25.1(a) or a transfer of a Share from a Member or deceased Member under this clause 25 is subject to the same limitations, restrictions and provisions of this Constitution as would apply if the election were a transfer or the transfer were made by the Member or deceased Member himself or herself.

 

25.4

A person who:

 

  (a)

has become entitled to a Share by operation of law; and

 

  (b)

has produced evidence of its entitlement which is satisfactory to the Directors, is entitled to the dividends and other rights of the registered holder of the Share.

 

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25.5

Where two or more persons are jointly entitled to any Share in consequence of the death of the registered holder, they will be considered to be joint holders of the Share.

CHANGES TO SHARE CAPITAL

 

26.

Consolidation or subdivision

For the purpose of giving effect to any consolidation or subdivision of Shares, the Directors may, subject to the ASTC Settlement Rules, settle any difficulty which arises with respect to fractions of Shares in any manner that they think expedient.

POWERS OF ATTORNEY

 

27.

Powers of attorney

 

27.1

If a Member executes or proposes to execute any document or do any act by or through an attorney in relation to the Company or Shares held by the Member, that Member must deliver the instrument appointing the attorney to the Company for notation.

 

27.2

The Company may require the Member to lodge a certified copy of the instrument for retention by the Company, and ask for whatever evidence it thinks appropriate that the power of attorney is effective and continues to be in force.

 

27.3

Any power of attorney granted by a Member will, as between the Company and the Member who granted the power of attorney:

 

  (a)

continue in force; and

 

  (b)

may be acted on,

unless express notice in writing of its revocation or of the death of the Member who granted it is lodged with the Company.

 

27.4

Where a Member proposes that an attorney represent the Member at a general meeting or adjourned meeting, the Member must comply with clause 48.2 of this Constitution.

GENERAL MEETINGS

 

28.

Convening

 

28.1

A Director may call a meeting of Members.

 

28.2

The Directors must convene annual general meetings in accordance with the Corporations Act, to be held by the Company at times to be determined by the Directors.

 

28.3

Members may also request or call and arrange to hold general meetings in accordance with the procedures for member-initiated meetings set out in the Corporations Act.

 

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29.

Notice

 

29.1

Members must be given at least 28 days written notice (exclusive of the day on which the notice is served or taken to be served and of the day for which notice is given) of a general meeting.

 

29.2

General meetings may be called on less than 28 days notice in accordance with the procedures set out in the Corporations Act.

 

29.3

A notice convening a general meeting must:

 

  (a)

specify the place, date and time of the meeting (and if the meeting is to be held in two or more places, the technology that will be used to facilitate this);

 

  (b)

state the general nature of the business to be transacted at the meeting;

 

  (c)

specify a place and facsimile number and may specify an electronic address for the purposes of proxy appointments; and

 

  (d)

comply with any other requirements of the Corporations Act.

 

30.

Business

 

30.1

The business of an annual general meeting will be to:

 

  (a)

consider the annual financial report and reports of the Directors and Auditor required by the Corporations Act;

 

  (b)

elect directors;

 

  (c)

where relevant, appoint and fix the remuneration of the Auditor; and

 

  (d)

transact any other business which under this Constitution may be transacted at a general meeting.

 

30.2

The Chairperson of an annual general meeting must allow a reasonable opportunity for the Members as a whole at the meeting to:

 

  (a)

ask questions about or make comments on the management of the Company;

 

  (b)

ask the Auditor or his or her representative questions relevant to the conduct of the audit and the preparation and contents of the Auditor’s report for the Company.

 

30.3 (a)

The Directors may postpone or cancel any general meeting (other than a meeting convened as the result of a requisition under clause 28.3) at any time before the day of the meeting.

 

17


  (b)

The Directors must give notice of the postponement or cancellation to all persons entitled to receive notices from the Company.

 

30.4

An accidental omission to send a notice of a general meeting (including a proxy appointment form) or the postponement of a general meeting to any Member or the non-receipt of a notice (or form) by any Member does not invalidate the proceedings at or any resolution passed at the general meeting.

PROCEEDINGS AT GENERAL MEETINGS

 

31.

Member

In clauses 32, 33, 36 and 41, ‘Member’ includes a Member present in person or by proxy, attorney or Representative.

 

32.

Quorum

 

32.1

No business may be transacted at a general meeting unless a quorum of Members is present when the meeting proceeds to business.

 

32.2

A quorum of Members is three Members.

 

32.3

If a quorum is not present within 30 minutes after the time appointed for a meeting:

 

  (a)

the meeting is automatically dissolved if it was convened by or on the requisition of Members; or

 

  (b)

in any other case:

 

  (i)

it will stand adjourned to the same time and place seven days after the meeting, or to another day, time and place determined by the Directors; and

 

  (ii)

if at the adjourned meeting a quorum is not present within 30 minutes after the time appointed for the meeting, two Members will be a quorum.

 

33.

Chairperson

 

33.1

The chairperson, or in the chairperson’s absence the deputy chairperson, of Directors’ meetings will be the chairperson at every meeting of Members.

 

33.2

If:

 

  (a)

there is no chairperson or deputy chairperson; or

 

  (b)

neither the chairperson nor deputy chairperson is present within 15 minutes after the time appointed for holding the meeting; or

 

18


  (c)

the chairperson and deputy chairperson are unwilling to act as chairperson of the meeting,

the Directors present may elect a chairperson.

 

33.3

If no election is made pursuant to clause 33.2, then:

 

  (a)

the Members may elect one of the Directors present as chairperson; or

 

  (b)

if no Director is present or is willing to take the chair, the Members may elect one of the Members present as chairperson.

 

33.4

If there is a dispute at a general meeting about a question of procedure, the chairperson may determine the question.

 

34.

General conduct

The general conduct of each general meeting of the Company and the procedures to be adopted at the meeting will be determined by the chairperson, including the procedure for the conduct of the election of Directors.

 

35.

Adjournment

 

35.1

The chairperson of a meeting at which a quorum is present:

 

  (a)

in his or her discretion may adjourn a meeting with the meeting’s consent; and

 

  (b)

must adjourn a meeting if the meeting directs him or her to do so.

 

35.2

An adjourned meeting may take place at a different venue from the initial meeting.

 

35.3

The only business that can be transacted at an adjourned meeting is the unfinished business of the initial meeting.

 

35.4

If a general meeting has been adjourned for more than 30 days, notice of the adjourned meeting must be given to Members as if it were an original meeting, but otherwise it is not necessary to give notice of an adjourned meeting or the business of the adjourned meeting.

 

35.5

A poll cannot be demanded on any resolution concerning the adjournment of a meeting except by the chairperson.

 

36.

Decisions

 

36.1

Subject to the Corporations Act in relation to special resolutions, a resolution is carried if a majority of the votes cast on the resolution are in favour of the resolution.

 

36.2

A resolution put to the vote of a meeting is decided on a show of hands unless a poll is demanded in accordance with the Corporations Act.

 

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36.3

A poll may be demanded at the times permitted by the Corporations Act.

 

36.4

Unless a poll is demanded:

 

  (a)

a declaration by the chairperson that a resolution has been carried, carried by a specified majority, or lost; and

 

  (b)

an entry to that effect in the minutes of the meeting,

are conclusive evidence of the fact without proof of the number or proportion of the votes in favour of or against the resolution.

 

36.5

The demand for a poll may be withdrawn.

 

36.6

A decision of a general meeting may not be impeached or invalidated on the ground that a person voting at the meeting was not entitled to do so.

 

37.

Taking a poll

 

37.1

Subject to clause 37.5, a poll will be taken when and in the manner that the chairperson directs.

 

37.2

The result of the poll will determine whether the resolution on which the poll was demanded is carried or lost.

 

37.3

The chairperson may determine any dispute about the admission or rejection of a vote, and such determination, if made in good faith, will be final and conclusive.

 

37.4

A poll cannot be demanded on any resolution concerning the election of the chairperson of a meeting.

 

37.5

A poll demanded by the chairperson of any resolution concerning the adjournment of a meeting must be taken immediately.

 

37.6

After a poll has been demanded at a meeting, the meeting may continue for the transaction of business other than the question on which the poll was demanded.

 

38.

Casting vote of chairperson

The chairperson does not have a casting vote (in addition to the chairperson’s votes as a Member, proxy, attorney or Representative) on a show of hands or on a poll.

 

39.

Offensive material

The chairperson may refuse a person admission to, or require the person to leave and not return to, a meeting if the person:

 

  (a)

refuses to permit examination of any article in the person’s possession; or

 

20


  (b)

is in possession of any:

 

  (i)

electronic or recording device;

 

  (ii)

placard or banner; or

 

  (iii)

other article,

which the chairperson considers to be dangerous, offensive or liable to cause disruption.

 

40.

Auditor’s right to be heard

The Auditor may:

 

  (a)

attend any general meeting of the Company;

 

  (b)

be heard at any general meeting of the Company on any part of the business of the meeting that concerns the Auditor in his or her capacity as auditor, even if:

 

  (i)

the Auditor retires at the meeting;

 

  (ii)

Members pass a resolution to remove the Auditor from office; and

 

  (c)

authorise a person in writing to attend and speak at any general meeting as the Auditor’s representative.

VOTES OF MEMBERS

 

41.

Entitlement to vote

 

41.1

Subject to this Constitution and to any rights or restrictions attaching to Shares:

 

  (a)

every Member may vote;

 

  (b)

subject to clause 45.3 and the Corporations Act, on a show of hands every Member has one vote;

 

  (c)

on a poll every Member has:

 

  (i)

for each fully paid Share held by the Member, one vote; and

 

  (ii)

for each partly paid Share held by the Member, a fraction of a vote equivalent to the proportion which the amount paid (not credited) is of the total amounts paid and payable (excluding amounts credited) on the Share.

 

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41.2

During a breach of the Listing Rules relating to Shares which are Restricted Securities, or a breach of a restriction agreement, the holder of the relevant Restricted Securities is not entitled to any voting rights in respect of those Restricted Securities.

 

41.3

If a Member is of unsound mind or is a person whose estate or property has had a personal representative, trustee or other person appointed to administer it, the Member’s personal representative, trustee or other person with the management of the Member’s estate or property may exercise any rights of the Member in relation to a meeting of Members as if the personal representative, trustee or other person was a Member.

 

42.

Unpaid calls

A Member is entitled to:

 

  (a)

vote; or

 

  (b)

be counted in a quorum,

only in respect of Shares on which all calls due and payable have been paid.

 

43.

Joint holders

 

43.1

If two or more joint holders purport to vote, the vote of the joint holder whose name appears first in the Register will be accepted, to the exclusion of the other joint holder or holders.

 

43.2

For the purposes of this clause 43, several executors or administrators of a deceased Member in whose sole name any Shares are registered will be taken to be joint holders of those Shares.

 

44.

Objections and Listing Rules

 

44.1

An objection to the qualification of a voter may only be raised at the meeting or adjourned meeting at which the voter tendered its vote.

 

44.2

An objection must be referred to the chairperson of the meeting, whose decision made in good faith is final.

 

44.3

Subject to clause 44.4, a vote which the chairperson does not disallow pursuant to an objection is valid for all purposes.

 

44.4

A vote which the Listing Rules require the Company to disregard is not valid.

 

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45.

Votes by proxy

 

45.1

Subject to clause 46.1, a Member who is entitled to vote at a meeting of the Company may appoint not more than two proxies to attend and vote at the meeting on that Member’s behalf.

 

45.2

If a Member appoints one proxy, that proxy may, subject to the Corporations Act, vote on a show of hands.

 

45.3

If a Member appoints two proxies neither proxy may vote on a show of hands.

 

45.4

A proxy may demand or join in demanding a poll.

 

46.

Instrument appointing proxy

 

46.1

A Member who is entitled to vote at a meeting may appoint:

 

  (a)

one proxy if the Member is only entitled to one vote; and

 

  (b)

one or two proxies if the Member is entitled to more than one vote.

 

46.2

A Member who is a natural person may appoint a proxy by a written appointment signed by the appointor or the appointor’s attorney duly authorised in writing.

 

46.3

A Member which is a corporation may appoint a proxy by a written appointment executed in accordance with section 127 of the Corporations Act or the appointor’s attorney duly authorised in writing.

 

46.4

A proxy need not be a Member.

 

46.5

If a Member appoints two proxies, the appointment may specify the proportion or number of votes that each proxy may exercise. If the appointment does not specify a proportion or number, each proxy may exercise half of the votes in which case any fraction of votes will be disregarded.

 

46.6   (a)

Except as permitted by the Directors or chairperson, a form of appointment of proxy is only valid if it complies with the requirements of the Corporations Act.

 

  (b)

Schedule 1 sets out a form of appointment of proxy approved by the Directors.

 

46.7

A proxy may vote or abstain as he or she chooses except to the extent that an appointment of the proxy indicates the manner in which the proxy will vote on any resolution. The proxy must vote or abstain on a poll or show of hands in accordance with any instructions on the appointment.

 

46.8

A proxy’s appointment is valid at an adjourned meeting.

 

23


47.

Proxy in blank

If an instrument of proxy is signed by the member but does not name the proxy or proxies in whose favour it is given, the chairperson may either act as proxy or complete the instrument of proxy by inserting the name or names of one or more Directors or the Secretary.

 

48.

Lodgment of proxy

 

48.1

Subject to clause 48.3, the written appointment of a proxy must be received by the Company, at least 48 hours (unless otherwise specified in the notice of meeting to which the proxy relates) before:

 

  (a)

the time for holding the meeting or adjourned meeting at which the appointee proposes to vote; or

 

  (b)

the taking of a poll on which the appointee proposes to vote.

 

48.2

If the appointment purports to be executed under a power of attorney or other authority, the original document or a notarially certified copy of it must be either:

 

  (a)

forwarded with the appointment; or

 

  (b)

produced at the meeting or adjourned meeting at which the appointee is authorised to vote.

 

48.3

The Company receives an appointment of a proxy and any power of attorney or other authority under which it was executed when they are received at:

 

  (a)

the Office;

 

  (b)

a facsimile number at the Office; or

 

  (c)

a place, facsimile number or electronic address specified for that purpose in the notice of meeting.

 

49.

Validity

A vote cast in accordance with an appointment of proxy or power of attorney is valid even if before the vote was cast the appointor:

 

  (a)

died;

 

  (b)

became of unsound mind;

 

  (c)

revoked the proxy or power; or

 

  (d)

transferred the Shares in respect of which the vote was cast,

 

24


unless any written notification of the death, unsoundness of mind, revocation or transfer was received by the Company before the relevant meeting or adjourned meeting.

 

50.

Representatives of corporations

 

50.1

Any Member which is a body corporate may appoint an individual as its representative in relation to meetings of Members or otherwise as permitted by the Corporations Act.

 

50.2

The chairperson of a general meeting may permit a person claiming to be a Representative to exercise his or her powers even if he or she has not produced a certificate evidencing his or her appointment.

 

50.3

The appointment of a Representative may set out restrictions on the Representative’s powers.

APPOINTMENT AND REMOVAL OF DIRECTORS

 

51.

Number of Directors

 

51.1

There will be:

 

  (a)

a minimum of three Directors; and

 

  (b)

a maximum of eight Directors.

 

51.2

The Directors and Secretary in office as at the date this Constitution is adopted by the Company continue in office subject to this Constitution.

 

52.

Qualification

Neither a Director nor an Alternate Director has to hold any Shares, but a Director (and an Alternate Director when acting as a Director) is entitled to notice of and to attend and speak at all general meetings.

 

53.

Power to remove and appoint

 

53.1

The Company may, subject to the Corporations Act, by resolution passed in general meeting:

 

  (a)

remove any Director before the end of the Director’s period of office; and

 

  (b)

appoint another person in the Director’s place.

 

53.2

A person appointed under clause 53.1(b) will hold office for the period for which the Director replaced would have held office if the Director had not been removed.

 

53.3

Subject to the provisions of this Constitution, the Company may appoint a person as a Director by resolution passed in general meeting.

 

25


53.4  (a)

If the conduct or position of any Director is such that continuance in office appears to the majority of the Directors to be prejudicial to the interests of the Company, a majority of Directors at a meeting of the Directors specifically convened for that purpose may suspend that Director.

 

  (b)

Within 14 days of the suspension, the Directors must call a general meeting, at which the Members may either confirm the suspension and remove the Director from office in accordance with clause 53.1(a) or annul the suspension and reinstate the Director.

 

54.

Additional and casual Directors

 

54.1

Subject to clause 51, the Directors may appoint any person as a Director to fill a casual vacancy or as an addition to the existing Directors.

 

54.2

A Director appointed under clause 54.1 will hold office until the next annual general meeting of the Company when the Director may be re-elected but will not be taken into account in determining the number of Directors who must retire by rotation.

 

55.

Filling vacated office

 

55.1

If a Director retires at a general meeting, the Company may by ordinary resolution elect a person to fill the vacated office.

 

55.2

If the vacated office is not filled and the retiring Director has offered himself or herself for re-election, the retiring Director will be considered to have been re-elected unless, at the meeting at which he or she retires:

 

  (a)

it is resolved not to fill the vacated office; or

 

  (b)

a resolution for the re-election of the Director is put and lost.

 

56.

Retirement by rotation

 

56.1

Subject to the Listing Rules and clause 73.7, at each annual general meeting one-third of the Directors or, if their number is not a multiple of three, then the number nearest to but not more than one-third of the Directors must retire from office.

 

56.2   (a)

The Directors to retire by rotation at an annual general meeting are those Directors who have been longest in office since their last election or appointment.

 

  (b)

Directors elected or appointed on the same day may agree among themselves or determine by lot which of them must retire.

 

26


56.3

Subject to clause 73.7, a Director must retire from office at the conclusion of the third annual general meeting after the Director was last elected, even if his or her retirement results in more than one-third of all Directors retiring from office.

 

56.4

A retiring Director will be eligible for re-election.

 

57.

Nomination of Director

 

57.1

A person is not eligible for election as a Director at a general meeting unless:

 

  (a)

the person is a Director retiring by rotation who seeks re-election; or

 

  (b)

the person is proposed by at least 50 Members or Members holding between them at least 5% of the votes that may be cast at a general meeting of the Company; and

 

  (c)

the proposing Members or Director leave a notice at the Office which nominates the candidate for the office of Director and includes the written consent of the person nominated.

 

57.2

A notice given in accordance with clause 57.1 must be left at the Office not less than 30 Business Days before the relevant general meeting.

 

58.

Vacation of office

 

58.1

The office of a Director immediately becomes vacant if the Director:

 

  (a)

ceases to be a Director by virtue of the Corporations Act;

 

  (b)

is prohibited by the Corporations Act from holding office or continuing as a Director;

 

  (c)

is prohibited from holding or is removed from the office of Director by an order made under the Corporations Act;

 

  (d)

becomes bankrupt or makes any general arrangement or composition with his or her creditors;

 

  (e)

cannot manage the Company because of his or her mental incapacity and is a person whose estate or property has had a personal representative or trustee appointed to administer it;

 

  (f)

resigns from his or her office of Director by notice in writing to the Company;

 

  (g)

is removed by a resolution of the Company; or

 

27


  (h)

not being engaged abroad on the business of the Company, is absent from Directors’ meetings for three consecutive months without leave of absence from the Directors.

 

58.2

A Director who holds any executive office in the Company (including the office of Managing Director) ceases to be a Director when he or she ceases to hold the executive office.

 

58.3

A person ceasing to be a Director by virtue of the provisions of clause 58.2 will not thereby be rendered ineligible for appointment or election as a Director under any clause other than clause 73.

REMUNERATION OF DIRECTORS

 

59.

Remuneration of Non-Executive Directors

 

59.1

Subject to the Listing Rules, the Directors (other than an Executive Director) may collectively be paid as remuneration for their services a fixed sum not exceeding the aggregate maximum sum from time to time determined by the Company in general meeting.

 

59.2

The notice convening a general meeting at which it is proposed that Members approve an increase of the aggregate maximum sum must state the amount of the increase and the aggregate maximum sum, and any other matters required by the Listing Rules.

 

59.3

Subject to the Listing Rules, the aggregate maximum sum will be divided among the Non-Executive Directors in such proportion and manner as the Directors agree and, in default of agreement, equally.

 

59.4

Non-Executive Directors may not be paid a commission on or a percentage of profits or operating revenue.

 

59.5

If a Non-Executive Director is required to perform services for the Company which in the opinion of the Directors are outside the scope of the ordinary duties of a Director, the Company may pay the Director a fixed sum determined by the Directors in addition to or instead of the Director’s remuneration under clause 59.1. No payment may be made under this clause 59.5 if the effect of the payment would be to exceed the aggregate amount of Directors’ remuneration determined by the Company in general meeting.

 

59.6

The Directors may also be paid all travelling, hotel and other expenses properly incurred by them in attending and returning from meetings of the Directors or any committee of the Directors or general meetings of the Company or otherwise in connection with the Company’s business.

 

28


59.7

The Company may also pay a premium in respect of a contract insuring a person who is or has been a Non-Executive Director against liability incurred by the person as a Director, except in circumstances prohibited by the Corporations Act.

 

60.

Remuneration of Executive Directors

 

60.1

The remuneration of an Executive Director may from time to time be fixed by the Directors. The remuneration may be by way of salary or commission or participation in profits or by all or any of these modes but may not be by commission on, or a percentage of, operating revenue.

 

60.2

The Company may pay a premium in respect of a contract insuring a person who is or has been an Executive Director against liability incurred by the person as a Director, except in circumstances prohibited by the Corporations Act.

 

61.

Benefit to retiring Directors

 

61.1

The Directors may:

 

  (a)

pay a gratuity, pension or allowance, on retirement or other vacation of office, to or for the benefit of a Director or to his widow or dependants; and

 

  (b)

make contributions to any fund and pay any premiums for the purchase or provision of any such gratuity, pension or allowance

in the circumstances provided in, and subject to the approval of Members if so required by, the Corporations Act.

 

61.2

The Directors may enter into a contract or arrangement with a prospective, present or former Director for the payment of benefits or the making of contributions of the kinds referred to in clause 61.1.

 

61.3

The Directors may establish or support or assist in the establishment or support of funds and trusts to provide pension, retirement, superannuation or similar payments or benefits to the Directors.

POWERS AND DUTIES OF DIRECTORS

 

62.

Directors to manage company

 

62.1

The business of the Company is managed by or under the direction of the Directors who may exercise all powers of the Company that this Constitution, the Corporations Act or the Listing Rules do not require to be exercised by the Company in general meeting.

 

62.2

Without limiting the generality of clause 62.1 but subject to the PDF Act, the Directors may exercise all the powers of the Company to:

 

29


  (a)

borrow money;

 

  (b)

charge any property or business of the Company or all or any of its uncalled capital;

 

  (c)

give any security for a debt, liability or obligation of the Company or of any other person; and

 

  (d)

guarantee or to become liable for the payment of money or the performance of any obligation by or of any other person.

PROCEEDINGS OF DIRECTORS

 

63.

Directors’ meetings

 

63.1

The chairperson, the deputy chairperson, or any Director may at any time, and the Secretary must on the request of the chairperson, the deputy chairperson, or any Director, call a meeting of the Directors.

 

63.2

An accidental omission to send a notice of a meeting of Directors to any Director or the non-receipt of such a notice by any Director does not invalidate the proceedings at or any resolution passed at the meeting.

 

63.3   (a)

Subject to the Corporations Act, a Directors’ meeting may be held by the Directors communicating with each other by any technological means by which they are able simultaneously to hear each other and to participate in discussion.

 

  (a)

The Directors need not all be physically present in the same place for a Directors’ meeting to be held.

 

  (b)

A Director who participates in a meeting held in accordance with this clause 63.3 is taken to be present and entitled to vote at the meeting.

 

63.4

Clause 63.3 applies to meetings of Directors’ committees as if all committee members were Directors.

 

63.5

The Directors may meet together, adjourn and regulate their meetings as they think fit.

 

63.6

Subject to the Corporations Act, a quorum for meetings of Directors may be fixed by the Directors and unless so fixed, is two.

 

63.7

Where a quorum cannot be established for the consideration of a particular matter at a meeting of Directors, the chairperson or the Managing Director may convene a general meeting of Members to deal with the matter.

 

63.8

Notice of a meeting of Directors may be given in writing, or the meeting may be otherwise called using any technology consented to by all the Directors.

 

30


64.

Decisions

 

64.1

Questions arising at a meeting of Directors are to be decided by a majority of votes of the Directors present and voting and, subject to clause 65, each Director has one vote.

 

64.2

The chairperson of a meeting has a casting vote in addition to his or her deliberative vote, except where only two Directors are present and entitled to vote.

 

64.3   (a)

An Alternate Director has one vote for each Director for whom he or she is an alternate.

 

  (b)

If the Alternate Director is a Director, he or she also has a vote as a Director.

 

65.

Directors’ interests

 

65.1

A Director who has a material personal interest in a matter that is to be considered at a meeting of Directors must not:

 

  (a)

vote on the matter or be present while the matter is being considered at the meeting; and

 

  (b)

be counted in the quorum in relation to that matter if to do so would be contrary to the Corporations Act.

 

65.2

Each Director must disclose to the Company particulars of:

 

  (a)

any material contract in which the Director is interested, including the names of the parties to the contract, particulars of the contract, and the Director’s interest in the contract, and

 

  (b)

any material personal interest in a matter that is being considered at a meeting of the board or of Directors.

 

65.3

Voting by a Director contrary to this clause 65, or failure by a Director to make disclosure under this clause, does not render void or voidable a contract in which the Director has an interest.

 

65.4

A Director and any firm, body or entity in which a Director has a direct or indirect interest may in any capacity:

 

  (a)

enter into any contract or arrangement with the Company;

 

  (b)

be appointed to and hold any office or place of profit under the Company, other than the office of auditor; and

 

  (c)

act in a professional capacity, other than as auditor, for the Company,

 

31


and provided that he or she makes disclosure as required by this clause 65, may receive and retain for his or her own benefit any remuneration, profits or benefits as if he or she were not a Director.

 

66.

Alternate Directors

 

66.1

A Director may, with the approval of the chairperson or the Managing Director, appoint any person as his or her alternate.

 

66.2

An Alternate Director is entitled to notice of Directors’ meetings while he or she is acting in that capacity and, if the appointor is not present at a meeting, is entitled to attend, be counted in a quorum and vote as a Director.

 

66.3

An Alternate Director is an officer of the Company and is not an agent of the appointor.

 

66.4

The provisions of this Constitution which apply to Directors also apply to Alternate Directors, except that Alternate Directors are not entitled in that capacity to any remuneration from the Company.

 

66.5   (a)

The appointment of an Alternate Director may be revoked at any time by the appointor or by the other Directors.

 

  (b)

An Alternate Director’s appointment ends automatically when his or her appointor ceases to be a Director.

 

66.6

Any appointment or revocation under this clause must be effected by written notice delivered to the Secretary.

 

66.7

For the purposes of clause 66, an Alternate Director does not have an interest in a contract or arrangement or a material personal interest in a matter by reason only of the fact that his or her appointor has such an interest.

 

67.

Remaining Directors

 

67.1

The Directors may act even if there are vacancies on the board.

 

67.2

If the number of Directors is not sufficient to constitute a quorum at a Directors’ meeting, the Director or Directors may act only to:

 

  (a)

appoint a Director; or

 

  (b)

convene a general meeting.

 

68.

Chairperson

 

68.1

The Directors may elect a Director as chairperson of Directors’ meetings and may determine the period for which the chairperson will hold office.

 

32


68.2

If no chairperson is elected or if the chairperson is not present at any Directors’ meeting within 10 minutes after the time appointed for the meeting to begin, the Directors present must elect a Director to be chairperson of the meeting.

 

68.3

The Directors may elect a Director as deputy chairperson to act as chairperson in the chairperson’s absence.

 

69.

Directors’ committees

 

69.1   (a)

The Directors may delegate any of their powers, other than those which by law must be dealt with by the Directors as a board, to a committee or committees.

 

  (b)

The Directors may at any time revoke any delegation of power to a committee.

 

69.2

At least one member of each committee must be a Director.

 

69.3

A committee must exercise its powers in accordance with any directions of the Directors and a power exercised in that way is taken to have been exercised by the Directors.

 

69.4

A committee may be authorised by the Directors to sub-delegate all or any of the powers for the time being vested in it.

 

69.5

Meetings of any committee will be governed by the provisions of this Constitution which deal with Directors’ meetings so far as they are applicable and are not inconsistent with any directions of the Directors.

 

70.

Written resolutions

 

70.1

If a majority of the Directors who are eligible to vote on a resolution have signed a document containing a statement that they are in favour of a resolution in terms set out in the document, then a resolution in those terms is taken to have been passed at a Directors’ meeting held on the day on which the document was last signed by a Director forming part of that majority.

 

70.2

For the purposes of clause 70.1, two or more identical documents, each of which is signed by one or more Directors, together constitute one document signed by those Directors on the days on which they signed the separate documents.

 

70.3

Any document referred to in this clause may be in the form of a facsimile transmission or electronic notification.

 

70.4

If a Directors’ meeting is taken to have been held in accordance with this clause, the minutes must record that fact.

 

70.5

This clause applies to meetings of Directors’ committees as if all members of the committee were Directors.

 

33


70.6

Any document referred to in this clause 70 must be sent to every Director who is entitled to vote on the resolution (whether or not the Director signs the document).

 

71.

Validity of acts of Directors

If it is discovered that:

 

  (a)

there was a defect in the appointment of a person as a Director, Alternate Director or member of a Directors’ committee; or

 

  (b)

a person appointed to one of those positions was disqualified;

all acts of the Directors or the Directors’ committee before the discovery was made are as valid as if the person had been duly appointed and was not disqualified.

 

72.

Minutes

 

72.1

The Directors must cause minutes to be made of:

 

  (a)

the names of the Directors present at all general meetings, Directors’ meetings and meetings of Directors’ committees;

 

  (b)

all proceedings and resolutions of general meetings, Directors’ meetings and meetings of Directors’ committees;

 

  (c)

all resolutions passed by Directors in accordance with clause 70;

 

  (d)

appointments of officers, but only if the Directors resolve that a minute of the appointment should be made; and

 

  (e)

all disclosures of interests made pursuant to clause 65.

 

72.2

Minutes must be signed by the chairperson of the meeting or by the chairperson of the next meeting of the relevant body, and if so signed will as between the Members be conclusive evidence of the matters stated in such minutes.

EXECUTIVE DIRECTORS

 

73.

Appointment

 

73.1   (a)

The Directors may appoint a Director to the office of Managing Director on such terms as they think fit.

 

  (b)

The Directors may appoint a Director to any other full-time or substantially full-time executive position in the Company on such terms as they think fit.

 

  (c)

A Director appointed under clause 73.1(a) or (b), and a Director (however appointed) occupying for the time being a full-time or substantially full-time executive position in the Company or a related body corporate, is referred to in this Constitution as an Executive Director.

 

34


73.2

The position of chairperson of Directors may be a full-time executive position if the Directors so resolve.

 

73.3

If the appointment of an Executive Director is for a fixed term, the term must not exceed five years.

 

73.4

The Directors may, subject to the terms of the Executive Director’s employment contract, suspend, remove or dismiss him or her from executive office and appoint another Director in that place.

 

73.5

If the Managing Director or the chairperson (if appointed to a full-time executive position) ceases to be a Director, his or her executive office terminates automatically.

 

73.6

If an Executive Director is suspended from executive office, his or her duties and obligations as Director are suspended for the same period.

 

73.7

A sole Managing Director is not subject to retirement by rotation and is not to be taken into account in determining the rotation of retirement of Directors.

 

74.

Powers of Executive Directors

 

74.1

The Directors may confer on an Executive Director any powers exercisable by the Directors, subject to any terms and restrictions determined by the Directors.

 

74.2

The Directors may authorise an Executive Director to sub-delegate all or any of the powers vested in him or her.

 

74.3

Any power conferred pursuant to this clause may be concurrent with but not to the exclusion of the Directors’ powers.

 

74.4

The Directors may at any time withdraw or vary any of the powers conferred on an Executive Director.

SECRETARY

 

75.

Secretary

 

75.1

There must be at least one secretary of the Company appointed by the Directors on conditions determined by them.

 

75.2

The Directors may, subject to the terms of the Secretary’s employment contract, suspend, remove or dismiss the Secretary.

 

35


SEALS

 

76.

Common seal

If the Company has a Seal:

 

  (a)

the Directors must provide for the safe custody of the Seal;

 

  (b)

it must not be used except with the authority of the Directors or a Directors’ committee authorised to permit use of the Seal;

 

  (c)

every document to which the Seal is affixed must be signed by a Director and be countersigned by another Director, the Secretary or another person appointed by the Directors to countersign the document; and

 

  (d)

the Directors may determine by resolution either generally or in any particular case that the signature of any Director or the Secretary to a document to which the Seal or a duplicate seal or certificate seal is affixed may be a facsimile applied to the document by specified mechanical means.

 

77.

Duplicate seal

If the Company has a Seal, the Company may have one or more duplicate seals of the Seal each of which:

 

  (a)

must be a facsimile of the Seal with the addition on its face of the words ‘Duplicate Seal’; and

 

  (b)

may only be used with the authority of the Directors or a Directors’ committee.

 

78.

Certificate seal

 

78.1

If the Company has a Seal, the Company may have a certificate seal which:

 

  (a)

may be affixed to Share, option or other certificates;

 

  (b)

must be a facsimile of the Seal with the addition on its face of the words ‘Certificate Seal’; and

 

  (c)

may only be used with the authority of the Directors or a Directors’ committee.

INSPECTION OF RECORDS

 

79.

Times for inspection

 

79.1

Except as otherwise required by the Corporations Act, the Directors may determine whether and to what extent, and at what times and places and under what conditions, the financial records and other documents of the Company or any of them will be open for inspection by Members other than Directors.

 

36


79.2

A Member other than a Director does not have the right to inspect any financial records or other documents of the Company unless the Member is authorised to do so by a court order or a resolution of the Directors.

DIVIDENDS AND RESERVES

 

80.

Dividends Generally

The Directors are authorised from time to time to make any and all decisions regarding dividends in respect of Shares, and which are permitted under the Corporations Act and the Listing Rules, including those expressly stated in this clause. Dividends shall (subject to clause 22.9, the rights of any preference Shareholders and to the right of the holders of any Shares created or raised under any special arrangement as to dividend), be payable on all Shares in accordance with Section 254W of the Corporations Act.

 

81.

Interim & Final Dividends

Subject to clause 22.9 the Directors may from time to time resolve to:

 

  (a)

pay such interim dividends as they may determine including at a stated future time, subject to revocation up to the time fixed for payment but giving rise to a debt at that time;

 

  (b)

determine that a dividend is payable at a stated future time, also subject to revocation up to the time fixed for payment but giving rise to a debt at that time; or

 

  (c)

declare a dividend payable at a stated future time giving rise to a debt when the dividend is declared, or if the dividend is declared subject to a condition precedent, when the condition precedent is satisfied.

 

82.

Permitted Dividends

No dividend shall be permitted except as may be determined by the Directors and which complies with section 254T of the Corporations Act, and the Listing Rules.

 

83.

No Interest

No dividend shall carry interest as against the Company.

 

84.

Reserves

The Directors may set aside out of the profits of the Company such amounts as they may determine as reserves, to be applied at the discretion of the Directors, for any purpose for which the profits of the Company may be properly applied.

 

37


85.

Alternative Method of Payment of Dividend

 

85.1

In relation to any permitted dividend, the Directors may:

 

  (a)

direct payment of the dividend to be made wholly or in part by the distribution of specific assets or documents of title (including, without limitation, paid-up Shares, debentures or debenture stock of this or any other company, gold, gold or mint certificates or receipts and like documents) or in any one or more of such ways, and where any difficulty arises with regard to the distribution the Directors may settle it as they think expedient and in particular may issue fractional certificates and may fix the value for distribution of such specific assets or any part of such assets and may determine that cash or other payments shall be made to any Shareholders upon the basis of the value so fixed in order to adjust the rights of all parties and may vest any such specific assets in trustees upon such trusts for the persons entitled to the dividend as may seem expedient to the Directors; or

 

  (b)

subject to the Listing Rules, direct that such dividend be payable to particular Shareholders wholly or partly out of any particular fund or reserve or from or as derived from any particular source and to the remaining Shareholders wholly or partly out of any other particular fund or reserve or out of or as derived from any other particular source and may so direct notwithstanding that by so doing the dividend will form part of the assessable income for taxation purposes of some Shareholders and will not form part of the assessable income of others.

 

85.2

If the Company is required to distribute to its Shareholders, by way of dividend, shares, options or other securities in another Corporation:

 

  (a)

the Shareholders will be deemed to have agreed to become members of that Corporation; and

 

  (b)

each of the Shareholders appoints the Company or any of the Directors as their agent to execute any transfer or other document required to effect the distribution of shares, options or other securities to the Shareholders.

 

86.

Payment of Dividends

All dividends shall be dispatched simultaneously to the Shareholders entitled to the dividend. Any one or two or more joint holders may give effectual receipts for any dividends, interest, or any other payment in respect of the Shares held by them as joint holders.

 

87.

Unclaimed Dividends

All dividends declared but unclaimed may be invested or otherwise made use of by the Directors as they think fit for the benefit of the Company until claimed or until required to be dealt with in accordance with any law relating to unclaimed moneys.

 

38


88.

Breach of Restriction Agreement

In the event of a breach of the Listing Rules relating to Restricted Securities or of any escrow agreement entered into by the Company under the Listing Rules in relation to any Shares which are classified under the Listing Rules or by ASX as Restricted Securities, the Shareholder holding the Shares in question shall cease to be entitled to any dividends or distribution in respect of those Shares for so long as the breach subsists.

 

89.

Election to reinvest dividend

The Directors may:

 

  (a)

establish a plan under which Members or any class of Members may elect to reinvest cash dividends paid by the Company by subscribing for Shares;

 

  (b)

vary, suspend or terminate the arrangements established under clause 89(a).

 

90.

Capitalisation of profits

 

90.1

The Directors may resolve to capitalise profits.

 

90.2

If the capitalisation is to be accompanied by the issue of Shares or debentures, the Directors may apply the sum capitalised:

 

  (a)

in the proportions in which the Members would be entitled if the sum was distributed by way of dividend; or

 

  (b)

in connection with an employee share scheme adopted by the Company, by applying the sum in paying up in part or full unissued Shares and issuing them in accordance with the rules of that scheme.

 

90.3

For the purposes of this clause 92, ‘employee share scheme’ has the same meaning as in section 9 of the Corporations Act.

 

90.4

To the extent necessary to adjust the rights of the Members among themselves where clause 92.2(a) applies or is intended to apply, the Directors may adopt a rounding policy or make cash payments in cases where Shares or debentures become issuable in fractions.

NOTICES

 

91.

Service of notices

 

91.1

Notice may be given by the Company to any person who is entitled to notice under this Constitution by:

 

  (a)

serving it on the person;

 

39


  (b)

sending it by post, facsimile transmission or electronic notification to the person at the person’s address shown in the Register or the address supplied by the person to the Company for sending notices to the person; or

 

  (c)

(except in the case of a notice of meeting of Members which is required to be given individually to each Member entitled to vote at the meeting and to each Director), advertising in one or more of the newspapers published in both the cities of Melbourne and Sydney as determined by the Directors, if in the opinion of the Directors extreme or unusual circumstances make it appropriate to do so.

 

91.2

A notice sent by post is taken to be served:

 

  (a)

by properly addressing, prepaying and posting a letter containing the notice; and

 

  (b)

three days after the day on which it was posted.

 

91.3

A notice sent by facsimile transmission or electronic notification is taken to be served:

 

  (a)

by properly addressing the facsimile transmission or electronic notification and transmitting it; and

 

  (b)

on the day of its transmission except if transmitted after 5.00pm in which case is taken to be served on the next day.

 

91.4

A notice given by advertisement is taken to be served on the date on which the advertisement first appears in a newspaper.

 

91.5

A notice may be served by the Company on joint holders under clause 93.1(a) or (b) by giving the notice to the joint holder whose name appears first in the Register.

 

91.6

Every person who is entitled to a Share by operation of law and who is not registered as the holder of the Share is taken to receive any notice served in accordance with this clause by advertisement or on the person from whom it derives title.

 

91.7

A Share certificate, cheque, warrant or other document may be delivered by the Company either personally or by sending it:

 

  (a)

in the case of a Member who does not have a Registered Address in Australia, by airmail post, by facsimile transmission, electronic notification or in another way that ensures that it will be received quickly, as appropriate; and

 

  (b)

in any other case by ordinary post.

 

91.8

A Member whose Registered Address is not in Australia may specify in writing an address in Australia as the Member’s Registered Address within the meaning of this clause.

 

40


91.9

A certificate in writing signed by a Director, Secretary or other officer of the Company, or by any person that the Company has engaged to maintain the Register, that a document or its envelope or wrapper was addressed and stamped and was posted is conclusive evidence of posting.

 

91.10

Subject to the Corporations Act the signature to a written notice given by the Company may be written or printed.

 

91.11

All notices sent by post outside Australia must be sent by prepaid airmail post.

 

92.

Persons entitled to notice

 

92.1

Notice of every general meeting must be given to:

 

  (a)

every Member;

 

  (b)

every Director and Alternate Director;

 

  (c)

the Exchange; and

 

  (d)

the Auditor.

 

92.2

No other person is entitled to receive notice of a general meeting.

AUDIT AND FINANCIAL RECORDS

 

93.

Company to keep financial records

 

93.1

The Directors must cause the Company to keep written financial records and to prepare financial documents and reports in accordance with the requirements of the Corporations Act and the Listing Rules.

 

93.2

The Directors must cause the financial records and financial documents of the Company to be audited in accordance with the requirements of the Corporations Act and the Listing Rules.

WINDING UP

 

94.

Winding up

 

94.1

Nothing in this clause prejudices the rights of the holders of Shares issued on special terms and conditions.

 

94.2

If the Company is wound up, the liquidator may, with the sanction of a special resolution of the Company:

 

  (a)

divide among the Members in kind all or any of the Company’s assets; and

 

41


  (b)

for that purpose, determine how he or she will carry out the division between the different classes of Members,

but may not require a Member to accept any Shares or other securities in respect of which there is any liability.

 

94.3

The liquidator may, with the sanction of a special resolution of the Company, vest all or any of the Company’s assets in a trustee on trusts determined by the liquidator for the benefit of the contributories.

INDEMNITY

 

95.

Indemnity

 

95.1

To the extent permitted by law and that the officer is not indemnified by directors’ and officers’ liability insurance maintained by the Company, the Company indemnifies every person who is or has been an officer of the Company against any liability incurred by that person:

 

  (a)

as such an officer of the Company; and

 

  (b)

to a person other than the Company or a related body corporate of the Company,

unless the liability arises out of conduct on the part of the officer which:

 

  (c)

involves a lack of good faith; or

 

  (d)

is contrary to the Company’s express instructions.

 

95.2

To the extent permitted by law and that the officer is not indemnified by directors’ and officers’ liability insurance maintained by the Company, the Company indemnifies every officer of the Company against any liability for costs and expenses incurred by the person in his or her capacity as officer of the Company:

 

  (a)

in defending any proceedings, whether civil or criminal, in which judgment is given in favour of the person or in which the person is acquitted; or

 

  (b)

in connection with an application, in relation to such proceedings, in which the Court grants relief to the person under the Corporations Act.

 

95.3

For the purposes of this clause, ‘officer’ includes:

 

  (a)

a Director and a Secretary;

 

  (b)

an executive officer of the Company as defined by the Corporations Act; and

 

42


  (c)

full-time employees of the Company as determined by the Directors. LISTING RULES AND ASTC SETTLEMENT RULES

 

96.

Listing Rules

If the Company is admitted to the Official List of ASX, the following clauses apply:

 

  (a)

Notwithstanding anything contained in this Constitution, if the Listing Rules prohibit an act being done, the act shall not be done.

 

  (b)

Nothing contained in this Constitution prevents an act being done that the Listing Rules require to be done.

 

  (c)

If the Listing Rules require an act to be done or not to be done, authority is given for that act to be done or not to be done (as the case may be).

 

  (d)

If the Listing Rules require this Constitution to contain a provision and it does not contain such a provision, this Constitution is deemed to contain that provision.

 

  (e)

If the Listing Rules require this Constitution not to contain a provision and it contains such a provision, this Constitution is deemed not to contain that provision.

 

  (f)

If any provision of this Constitution is or becomes inconsistent with the Listing Rules, this Constitution is deemed not to contain that provision to the extent of the inconsistency.

 

97.

ASTC Settlement Rules

Where the securities of the Company are CHESS approved securities, the Company shall comply with the ASTC Settlement Rules.

INADVERTENT OMISSIONS

 

98.

Formalities Omitted

If some formality required by this Constitution is inadvertently omitted or is not carried out the omission does not invalidate any resolution, act, matter or thing which but for the omission would have been valid unless it is proved to the satisfaction of the directors that the omission has directly prejudiced any Shareholder financially. The decision of the directors is final and binding on all Shareholders.

 

43

EX-2.1

Exhibit 2.1

 

 

 

AVITA MEDICAL LIMITED

(ABN 989 008 624 961)

AND

THE BANK OF NEW YORK MELLON

As Depositary

AND

OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES

Deposit Agreement

                    , 2019

 

 

 


TABLE OF CONTENTS

 

 

ARTICLE 1.   DEFINITIONS

     1  
 

SECTION 1.1.

  American Depositary Shares.      1  
 

SECTION 1.2.

  CHESS      2  
 

SECTION 1.3.

  Commission.      2  
 

SECTION 1.4.

  Company.      2  
 

SECTION 1.5.

  Custodian.      2  
 

SECTION 1.6.

  Delisting Event.      2  
 

SECTION 1.7.

  Deliver; Surrender.      2  
 

SECTION 1.8.

  Deposit Agreement.      3  
 

SECTION 1.9.

  Depositary; Depositary’s Office.      3  
 

SECTION 1.10.

  Deposited Securities.      3  
 

SECTION 1.11.

  Disseminate.      4  
 

SECTION 1.12.

  Dollars.      4  
 

SECTION 1.13.

  DTC.      4  
 

SECTION 1.14.

  Foreign Registrar.      4  
 

SECTION 1.15.

  Holder.      4  
 

SECTION 1.16.

  Insolvency Event.      4  
 

SECTION 1.17.

  Owner.      5  
 

SECTION 1.18.

  Receipts.      5  
 

SECTION 1.19.

  Registrar.      5  
 

SECTION 1.20.

  Replacement.      5  
 

SECTION 1.21.

  Restricted Securities.      5  
 

SECTION 1.22.

  Securities Act of 1933.      5  
 

SECTION 1.23.

  Shares.      6  
 

SECTION 1.24.

  SWIFT.      6  
 

SECTION 1.25.

  Termination Option Event.      6  
 

ARTICLE 2.   FORM OF RECEIPTS, DEPOSIT OF SHARES, DELIVERY, TRANSFER AND SURRENDER OF AMERICAN DEPOSITARY SHARES

     6  
 

SECTION 2.1.

  Form of Receipts; Registration and Transferability of American Depositary Shares.      6  
 

SECTION 2.2.

  Deposit of Shares.      7  
 

SECTION 2.3.

  Delivery of American Depositary Shares.      8  
 

SECTION 2.4.

  Registration of Transfer of American Depositary Shares; Combination and Split-up of Receipts; Interchange of Certificated and Uncertificated American Depositary Shares.      9  
 

SECTION 2.5.

  Surrender of American Depositary Shares and Withdrawal of Deposited Securities.      10  

 

-i-


 

SECTION 2.6.

  Limitations on Delivery, Transfer and Surrender of American Depositary Shares.      11  
 

SECTION 2.7.

  Lost Receipts, etc.      11  
 

SECTION 2.8.

  Cancellation and Destruction of Surrendered Receipts.      12  
 

SECTION 2.9.

  DTC Direct Registration System and Profile Modification System.      12  
 

ARTICLE 3.   CERTAIN OBLIGATIONS OF OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES

     12  
 

SECTION 3.1.

  Filing Proofs, Certificates and Other Information.      12  
 

SECTION 3.2.

  Liability of Owner for Taxes.      13  
 

SECTION 3.3.

  Warranties on Deposit of Shares.      14  
 

SECTION 3.4.

  Disclosure of Interests.      14  
 

ARTICLE 4.   THE DEPOSITED SECURITIES

     14  
 

SECTION 4.1.

  Cash Distributions.      14  
 

SECTION 4.2.

  Distributions Other Than Cash, Shares or Rights.      15  
 

SECTION 4.3.

  Distributions in Shares.      16  
 

SECTION 4.4.

  Rights.      16  
 

SECTION 4.5.

  Conversion of Foreign Currency.      18  
 

SECTION 4.6.

  Fixing of Record Date.      19  
 

SECTION 4.7.

  Voting of Deposited Shares.      19  
 

SECTION 4.8.

  Tender and Exchange Offers; Redemption, Replacement or Cancellation of Deposited Securities.      20  
 

SECTION 4.9.

  Reports.      22  
 

SECTION 4.10.

  Lists of Owners.      22  
 

SECTION 4.11.

  Withholding.      22  
 

ARTICLE 5.   THE DEPOSITARY, THE CUSTODIANS AND THE COMPANY

     23  
 

SECTION 5.1.

  Maintenance of Office and Transfer Books by the Depositary.      23  
 

SECTION 5.2.

  Prevention or Delay of Performance by the Company or the Depositary.      23  
 

SECTION 5.3.

  Obligations of the Depositary and the Company.      24  
 

SECTION 5.4.

  Resignation and Removal of the Depositary.      26  
 

SECTION 5.5.

  The Custodians.      26  
 

SECTION 5.6.

  Notices and Reports.      27  
 

SECTION 5.7.

  Distribution of Additional Shares, Rights, etc.      27  
 

SECTION 5.8.

  Indemnification.      28  
 

SECTION 5.9.

  Charges of Depositary.      29  

 

-ii-


 

SECTION 5.10.

  Retention of Depositary Documents.      30  
 

SECTION 5.11.

  Exclusivity.      30  
 

SECTION 5.12.

  Information for Regulatory Compliance.      30  
 

ARTICLE 6.   AMENDMENT AND TERMINATION

     30  
 

SECTION 6.1.

  Amendment.      30  
 

SECTION 6.2.

  Termination.      31  
 

ARTICLE 7.   MISCELLANEOUS

     32  
 

SECTION 7.1.

  Counterparts; Signatures.      32  
 

SECTION 7.2.

  No Third Party Beneficiaries.      32  
 

SECTION 7.3.

  Severability.      33  
 

SECTION 7.4.

  Owners and Holders as Parties; Binding Effect.      33  
 

SECTION 7.5.

  Notices.      33  
 

SECTION 7.6.

  Appointment of Agent for Service of Process; Submission to Jurisdiction; Jury Trial Waiver.      34  
 

SECTION 7.7.

  Waiver of Immunities.      35  
 

SECTION 7.8.

  Governing Law.      35  

 

-iii-


DEPOSIT AGREEMENT

DEPOSIT AGREEMENT dated as of                     , 2019 among AVITA MEDICAL LIMITED (ABN 98 008 624 691), a company incorporated under the laws of the Commonwealth of Australia (herein called the Company), THE BANK OF NEW YORK MELLON, a New York banking corporation (herein called the Depositary), and all Owners and Holders (each as hereinafter defined) from time to time of American Depositary Shares issued hereunder.

W I T N E S S E T H:

WHEREAS, the Company desires to provide, as set forth in this Deposit Agreement, for the deposit of Shares (as hereinafter defined) of the Company from time to time with the Depositary or with the Custodian (as hereinafter defined) under this Deposit Agreement, for the creation of American Depositary Shares representing the Shares so deposited and for the execution and delivery of American Depositary Receipts evidencing the American Depositary Shares; and

WHEREAS, the American Depositary Receipts are to be substantially in the form of Exhibit A annexed to this Deposit Agreement, with appropriate insertions, modifications and omissions, as set forth in this Deposit Agreement;

NOW, THEREFORE, in consideration of the premises, it is agreed by and between the parties hereto as follows:

 

ARTICLE

1.    DEFINITIONS

The following definitions shall for all purposes, unless otherwise clearly indicated, apply to the respective terms used in this Deposit Agreement:

SECTION 1.1.    American Depositary Shares.

The term “American Depositary Shares” shall mean the securities created under this Deposit Agreement representing rights with respect to the Deposited Securities. American Depositary Shares may be certificated securities evidenced by Receipts or uncertificated securities. The form of Receipt annexed as Exhibit A to this Deposit Agreement shall be the prospectus required under the Securities Act of 1933 for sales of both certificated and uncertificated American Depositary Shares. Except for those provisions of this Deposit Agreement that refer specifically to Receipts, all the provisions of this Deposit Agreement shall apply to both certificated and uncertificated American Depositary Shares.

Each American Depositary Share shall represent the number of Shares specified in Exhibit A to this Deposit Agreement, except that, if there is a distribution upon Deposited Securities covered by Section 4.3, a change in Deposited Securities covered by

 

-1-


Section 4.8 with respect to which additional American Depositary Shares are not delivered or a sale of Deposited Securities under Section 3.2 or 4.8, each American Depositary Share shall thereafter represent the amount of Shares or other Deposited Securities that are then on deposit per American Depositary Share after giving effect to that distribution, change or sale.

SECTION 1.2.    CHESS

The term “CHESS” shall mean the Clearing House Electronic Subregister System.

SECTION 1.3.    Commission.

The term “Commission” shall mean the Securities and Exchange Commission of the United States or any successor governmental agency in the United States.

SECTION 1.4.    Company.

The term “Company” shall mean Avita Medical Limited (ABN 98 008 624 691), a company incorporated under the laws of the Commonwealth of Australia, and its successors.

SECTION 1.5.    Custodian.

The term “Custodian” shall mean National Australia Bank Ltd., as custodian for the Depositary in Melbourne, Australia for the purposes of this Deposit Agreement, and any other firm or corporation the Depositary appoints under Section 5.5 as a substitute or additional custodian under this Deposit Agreement, and shall also mean all of them collectively.

SECTION 1.6.    Delisting Event.

A “Delisting Event” occurs if the American Depositary Shares are delisted from a securities exchange on which the American Depositary Shares were listed and the Company has not listed or applied to list the American Depositary Shares on any other securities exchange.

SECTION 1.7.    Deliver; Surrender.

(a)    The term “deliver”, or its noun form, when used with respect to Shares or other Deposited Securities, shall mean (i) book-entry transfer of those Shares or other Deposited Securities to an account maintained by CHESS or an institution authorized under applicable law to effect transfers of such securities designated by the person entitled to that delivery or (ii) physical transfer of certificates evidencing those Shares or other Deposited Securities registered in the name of, or duly endorsed or accompanied by proper instruments of transfer to, the person entitled to that delivery.

 

-2-


(b)    The term “deliver”, or its noun form, when used with respect to American Depositary Shares, shall mean (i) registration of those American Depositary Shares in the name of DTC or its nominee and book-entry transfer of those American Depositary Shares to an account at DTC designated by the person entitled to that delivery, (ii) registration of those American Depositary Shares not evidenced by a Receipt on the books of the Depositary in the name requested by the person entitled to that delivery and mailing to that person of a statement confirming that registration or (iii) if requested by the person entitled to that delivery, execution and delivery at the Depositary’s Office to the person entitled to that delivery of one or more Receipts evidencing those American Depositary Shares registered in the name requested by that person.

(c)    The term “surrender”, when used with respect to American Depositary Shares, shall mean (i) one or more book-entry transfers of American Depositary Shares to the DTC account of the Depositary, (ii) delivery to the Depositary at its Office of an instruction to surrender American Depositary Shares not evidenced by a Receipt or (iii) surrender to the Depositary at its Office of one or more Receipts evidencing American Depositary Shares.

SECTION 1.8.    Deposit Agreement.

The term “Deposit Agreement” shall mean this Deposit Agreement, as it may be amended from time to time in accordance with the provisions of this Deposit Agreement.

SECTION 1.9.    Depositary; Depositarys Office.

The term “Depositary” shall mean The Bank of New York Mellon, a New York banking corporation, and any successor as depositary under this Deposit Agreement. The term “Office”, when used with respect to the Depositary, shall mean the office at which its depositary receipts business is administered, which, at the date of this Deposit Agreement, is located at 240 Greenwich Street, New York, New York 10286.

SECTION 1.10.    Deposited Securities.

The term “Deposited Securities” as of any time shall mean Shares at such time deposited or deemed to be deposited under this Deposit Agreement, including without limitation, Shares that have not been successfully delivered upon surrender of American Depositary Shares, and any and all other securities, property and cash received by the Depositary or the Custodian in respect of Deposited Securities and at that time held under this Deposit Agreement.

 

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SECTION 1.11.    Disseminate.

The term “Disseminate,” when referring to a notice or other information to be sent by the Depositary to Owners, shall mean (i) sending that information to Owners in paper form by mail or another means or (ii) with the consent of Owners, another procedure that has the effect of making the information available to Owners, which may include (A) sending the information by electronic mail or electronic messaging or (B) sending in paper form or by electronic mail or messaging a statement that the information is available and may be accessed by the Owner on an Internet website and that it will be sent in paper form upon request by the Owner, when that information is so available and is sent in paper form as promptly as practicable upon request.

SECTION 1.12.    Dollars.

The term “Dollars” shall mean United States dollars.

SECTION 1.13.    DTC.

The term “DTC” shall mean The Depository Trust Company or its successor.

SECTION 1.14.    Foreign Registrar.

The term “Foreign Registrar” shall mean the entity that carries out the duties of registrar for the Shares and any other agent of the Company for the transfer and registration of Shares, including, without limitation, any securities depository for the Shares.

SECTION 1.15.    Holder.

The term “Holder” shall mean any person holding a Receipt or a security entitlement or other interest in American Depositary Shares, whether for its own account or for the account of another person, but that is not the Owner of that Receipt or those American Depositary Shares.

SECTION 1.16.    Insolvency Event.

An “Insolvency Event” occurs if the Company institutes proceedings to be adjudicated as bankrupt or insolvent, consents to the institution of bankruptcy or insolvency proceedings against it, files a petition or answer or consent seeking reorganization or relief under any applicable law in respect of bankruptcy or insolvency, consents to the filing of any petition of that kind or to the appointment of a receiver, liquidator, assignee, trustee, custodian or sequestrator (or other similar official) of it or any substantial part of its property or makes an assignment for the benefit of creditors, or if information becomes publicly available indicating that unsecured claims against the Company are not expected to be paid.

 

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SECTION 1.17.    Owner.

The term “Owner” shall mean the person in whose name American Depositary Shares are registered on the books of the Depositary maintained for that purpose.

SECTION 1.18.    Receipts.

The term “Receipts” shall mean the American Depositary Receipts issued under this Deposit Agreement evidencing certificated American Depositary Shares, as the same may be amended from time to time in accordance with the provisions of this Deposit Agreement.

SECTION 1.19.    Registrar.

The term “Registrar” shall mean any corporation or other entity that is appointed by the Depositary to register American Depositary Shares and transfers of American Depositary Shares as provided in this Deposit Agreement.

SECTION 1.20.    Replacement.

The term “Replacement” shall have the meaning assigned to it in Section 4.8.

SECTION 1.21.    Restricted Securities.

The term “Restricted Securities” shall mean Shares that (i) are “restricted securities,” as defined in Rule 144 under the Securities Act of 1933, except for Shares that could be resold in reliance on Rule 144 without any conditions, (ii) are beneficially owned by an officer, director (or person performing similar functions) or other affiliate of the Company, (iii) otherwise would require registration under the Securities Act of 1933 in connection with the public offer and sale thereof in the United States or (iv) are subject to other restrictions on sale or deposit under the laws of the Commonwealth of Australia, a shareholder agreement or the articles of association or similar document of the Company.

SECTION 1.22.    Securities Act of 1933.

The term “Securities Act of 1933” shall mean the United States Securities Act of 1933, as from time to time amended.

 

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SECTION 1.23.    Shares.

The term “Shares” shall mean ordinary shares of the Company that are validly issued and outstanding, fully paid and nonassessable and that were not issued in violation of any pre-emptive or similar rights of the holders of outstanding securities of the Company; provided, however, that, if there shall occur any change in nominal or par value, a split-up or consolidation or any other reclassification or, upon the occurrence of an event described in Section 4.8, an exchange or conversion in respect of the Shares of the Company, the term “Shares” shall thereafter also mean the successor securities resulting from such change in nominal value, split-up or consolidation or such other reclassification or such exchange or conversion.

SECTION 1.24.    SWIFT.

The term “SWIFT” shall mean the financial messaging network operated by the Society for Worldwide Interbank Financial Telecommunication, or its successor.

SECTION 1.25.    Termination Option Event.

The term “Termination Option Event” shall mean an event of a kind defined as such in Section 4.1, 4.2 or 4.8.

 

ARTICLE 2.

FORM OF RECEIPTS, DEPOSIT OF SHARES, DELIVERY, TRANSFER AND SURRENDER OF AMERICAN DEPOSITARY SHARES

SECTION 2.1.    Form of Receipts; Registration and Transferability of American Depositary Shares.

Definitive Receipts shall be substantially in the form set forth in Exhibit A to this Deposit Agreement, with appropriate insertions, modifications and omissions, as permitted under this Deposit Agreement. No Receipt shall be entitled to any benefits under this Deposit Agreement or be valid or obligatory for any purpose, unless that Receipt has been (i) executed by the Depositary by the manual signature of a duly authorized officer of the Depositary or (ii) executed by the facsimile signature of a duly authorized officer of the Depositary and countersigned by the manual signature of a duly authorized signatory of the Depositary or the Registrar or a co-registrar. The Depositary shall maintain books on which (x) each Receipt so executed and delivered as provided in this Deposit Agreement and each transfer of that Receipt and (y) all American Depositary Shares delivered as provided in this Deposit Agreement and all registrations of transfer of American Depositary Shares, shall be registered. A Receipt bearing the facsimile signature of a person that was at any time a proper officer of the Depositary shall, subject to the other provisions of this paragraph, bind the Depositary, even if that person was not a proper officer of the Depositary on the date of issuance of that Receipt.

 

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The Receipts and statements confirming registration of American Depositary Shares may have incorporated in or attached to them such legends or recitals or modifications not inconsistent with the provisions of this Deposit Agreement as may reasonably be required by the Company or the Depositary or required to comply with any applicable law or regulations thereunder or with the rules and regulations of any securities exchange upon which American Depositary Shares may be listed or to conform with any usage with respect thereto, or to indicate any special limitations or restrictions to which any particular Receipts and American Depositary Shares are subject by reason of the date of issuance of the underlying Deposited Securities or otherwise.

American Depositary Shares evidenced by a Receipt, when the Receipt is properly endorsed or accompanied by proper instruments of transfer, shall be transferable as certificated registered securities under the laws of the State of New York. American Depositary Shares not evidenced by Receipts shall be transferable as uncertificated registered securities under the laws of the State of New York. The Depositary, notwithstanding any notice to the contrary, may treat the Owner of American Depositary Shares as the absolute owner thereof for the purpose of determining the person entitled to distribution of dividends or other distributions or to any notice provided for in this Deposit Agreement and for all other purposes, and neither the Depositary nor the Company shall have any obligation or be subject to any liability under this Deposit Agreement to any Holder of American Depositary Shares (but only to the Owner of those American Depositary Shares).

SECTION 2.2.    Deposit of Shares.

Subject to the terms and conditions of this Deposit Agreement, Shares or evidence of rights to receive Shares may be deposited under this Deposit Agreement by delivery thereof to any Custodian, accompanied by any appropriate instruments or instructions for transfer, or endorsement, in form satisfactory to the Custodian.

As conditions of accepting Shares for deposit, the Depositary may require (i) any certification required by the Depositary or the Custodian in accordance with the provisions of this Deposit Agreement, (ii) a written order directing the Depositary to deliver to, or upon the written order of, the person or persons stated in that order American Depositary Shares representing those deposited Shares, (iii) evidence satisfactory to the Depositary that those Shares have been re-registered in the books of the Company or the Foreign Registrar in the name of the Depositary, a Custodian or a nominee of the Depositary or a Custodian, (iv) evidence satisfactory to the Depositary that any necessary approval for the transfer or deposit has been granted by any governmental body in each applicable jurisdiction and (v) an agreement or assignment, or other instrument satisfactory to the Depositary, that provides for the prompt transfer to the Custodian of any dividend, or right to subscribe for additional Shares or to receive other property, that any person in whose name those Shares are or have been recorded may thereafter receive upon or in respect of those Shares, or, in lieu thereof, such agreement of indemnity or other agreement as shall be satisfactory to the Depositary.

 

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At the request and risk and expense of a person proposing to deposit Shares, and for the account of that person, the Depositary may receive certificates for Shares to be deposited, together with the other instruments specified in this Section, for the purpose of forwarding those Share certificates to the Custodian for deposit under this Deposit Agreement.

The Depositary shall refuse, and shall instruct the Custodian to refuse, to accept Shares for deposit if the Depositary has received a notice from the Company that the Company has restricted transfer of those Shares under the Company’s articles of association or any applicable laws or that the deposit would result in any violation of the Company’s articles of association or any applicable laws.

The Depositary shall instruct each Custodian that, upon each delivery to a Custodian of a certificate or certificates for Shares to be deposited under this Deposit Agreement, together with the other documents specified in this Section, that Custodian shall, as soon as transfer and recordation can be accomplished, present that certificate or those certificates to the Company or the Foreign Registrar, if applicable, for transfer and recordation of the Shares being deposited in the name of the Depositary or its nominee or that Custodian or its nominee.

Deposited Securities shall be held by the Depositary or by a Custodian for the account and to the order of the Depositary or at such other place or places as the Depositary shall determine.

SECTION 2.3.    Delivery of American Depositary Shares.

The Depositary shall instruct each Custodian that, upon receipt by that Custodian of any deposit pursuant to Section 2.2, together with the other documents or evidence required under that Section, that Custodian shall notify the Depositary of that deposit and the person or persons to whom or upon whose written order American Depositary Shares are deliverable in respect thereof. Upon receiving a notice of a deposit from a Custodian, or upon the receipt of Shares or evidence of the right to receive Shares by the Depositary, the Depositary, subject to the terms and conditions of this Deposit Agreement, shall, without unreasonable delay, deliver, to or upon the order of the person or persons entitled thereto, the number of American Depositary Shares issuable in respect of that deposit, but only upon payment to the Depositary of the fees and expenses of the Depositary for the delivery of those American Depositary Shares as provided in Section 5.9, and of all taxes and governmental charges and fees payable in connection with that deposit and the transfer of the deposited Shares. However, the Depositary shall deliver only whole numbers of American Depositary Shares.

 

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SECTION 2.4.    Registration of Transfer of American Depositary Shares; Combination and Split-up of Receipts; Interchange of Certificated and Uncertificated American Depositary Shares.

The Depositary, subject to the terms and conditions of this Deposit Agreement, shall register a transfer of American Depositary Shares on its transfer books upon (i) in the case of certificated American Depositary Shares, surrender of the Receipt evidencing those American Depositary Shares, by the Owner or by a duly authorized attorney, properly endorsed or accompanied by proper instruments of transfer or (ii) in the case of uncertificated American Depositary Shares, receipt from the Owner of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9), and, in either case, duly stamped as may be required by the laws of the State of New York and of the United States of America. Upon registration of a transfer, the Depositary shall deliver the transferred American Depositary Shares to or upon the order of the person entitled thereto.

The Depositary, subject to the terms and conditions of this Deposit Agreement, shall upon surrender of a Receipt or Receipts for the purpose of effecting a split-up or combination of such Receipt or Receipts, execute and deliver a new Receipt or Receipts for any authorized number of American Depositary Shares requested, evidencing the same aggregate number of American Depositary Shares as the Receipt or Receipts surrendered.

The Depositary, upon surrender of certificated American Depositary Shares for the purpose of exchanging for uncertificated American Depositary Shares, shall cancel the Receipt evidencing those certificated American Depositary Shares and send the Owner a statement confirming that the Owner is the owner of the same number of uncertificated American Depositary Shares. The Depositary, upon receipt of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9) from the Owner of uncertificated American Depositary Shares for the purpose of exchanging for certificated American Depositary Shares, shall cancel those uncertificated American Depositary Shares and register and deliver to the Owner a Receipt evidencing the same number of certificated American Depositary Shares.

The Depositary may appoint one or more co-transfer agents for the purpose of effecting registration of transfers of American Depositary Shares and combinations and split-ups of Receipts at designated transfer offices on behalf of the Depositary. In carrying out its functions, a co-transfer agent may require evidence of authority and compliance with applicable laws and other requirements by Owners or persons entitled to American Depositary Shares and will be entitled to protection and indemnity to the same extent as the Depositary. The Depositary shall notify the Company if it appoints a co-transfer agent under this paragraph.

 

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SECTION 2.5.    Surrender of American Depositary Shares and Withdrawal of Deposited Securities.

Upon surrender of American Depositary Shares for the purpose of withdrawal of the Deposited Securities represented thereby and payment of the fee of the Depositary for the surrender of American Depositary Shares as provided in Section 5.9 and payment of all taxes and governmental charges payable in connection with that surrender and withdrawal of the Deposited Securities, and subject to the terms and conditions of this Deposit Agreement, the Owner of those American Depositary Shares shall be entitled to delivery (to the extent delivery can then be lawfully and practicably made), to or as instructed by that Owner, of the amount of Deposited Securities at the time represented by those American Depositary Shares, but not any money or other property as to which a record date for distribution to Owners has passed (since money or other property of that kind will be delivered or paid on the scheduled payment date to the Owner as of that record date), and except that the Depositary shall not be required to accept surrender of American Depositary Shares for the purpose of withdrawal to the extent it would require delivery of a fraction of a Deposited Security. That delivery shall be made, as provided in this Section, without unreasonable delay.

As a condition of accepting a surrender of American Depositary Shares for the purpose of withdrawal of Deposited Securities, the Depositary may require (i) that each surrendered Receipt be properly endorsed in blank or accompanied by proper instruments of transfer in blank and (ii) that the surrendering Owner execute and deliver to the Depositary a written order directing the Depositary to cause the Deposited Securities being withdrawn to be delivered to or upon the written order of a person or persons designated in that order.

Thereupon, the Depositary shall direct the Custodian to deliver, subject to Sections 2.6, 3.1 and 3.2, the other terms and conditions of this Deposit Agreement and local market rules and practices, to the surrendering Owner or to or upon the written order of the person or persons designated in the order delivered to the Depositary as above provided, the amount of Deposited Securities represented by the surrendered American Depositary Shares, and the Depositary may charge the surrendering Owner a fee and its expenses for giving that direction by cable (including SWIFT) or facsimile transmission.

If Deposited Securities are delivered physically upon surrender of American Depositary Shares for the purpose of withdrawal, that delivery will be made at the Custodian’s office, except that, at the request, risk and expense of an Owner surrendering American Depositary Shares for withdrawal of Deposited Securities, and for the account of that Owner, the Depositary shall direct the Custodian to forward any cash or other property comprising, and forward a certificate or certificates, if applicable, and other proper documents of title, if any, for, the Deposited Securities represented by the surrendered American Depositary Shares to the Depositary for delivery at the Depositary’s Office or to another address specified in the order received from the surrendering Owner.

 

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SECTION 2.6.    Limitations on Delivery, Transfer and Surrender of American Depositary Shares.

As a condition precedent to the delivery, registration of transfer or surrender of any American Depositary Shares or split-up or combination of any Receipt or withdrawal of any Deposited Securities, the Depositary, Custodian or Registrar may require payment from the depositor of Shares or the presenter of the Receipt or instruction for registration of transfer or surrender of American Depositary Shares not evidenced by a Receipt of a sum sufficient to reimburse it for any tax or other governmental charge and any stock transfer or registration fee with respect thereto (including any such tax or charge and fee with respect to Shares being deposited or withdrawn) and payment of any applicable fees as provided in this Deposit Agreement, may require the production of proof satisfactory to it as to the identity and genuineness of any signature and may also require compliance with any regulations the Depositary may establish consistent with the provisions of this Deposit Agreement, including, without limitation, this Section 2.6.

The delivery of American Depositary Shares against deposit of Shares generally or against deposit of particular Shares may be suspended, or the registration of transfer of American Depositary Shares in particular instances may be refused, or the registration of transfer of outstanding American Depositary Shares generally may be suspended, during any period when the transfer books of the Depositary are closed, or if any such action is deemed necessary or advisable by the Depositary or the Company at any time or from time to time because of any requirement of law or of any government or governmental body or commission, or under any provision of this Deposit Agreement, or for any other reason. Notwithstanding anything to the contrary in this Deposit Agreement, the surrender of outstanding American Depositary Shares and withdrawal of Deposited Securities may not be suspended, subject only to (i) temporary delays caused by closing of the transfer books of the Depositary or the Company or the Foreign Registrar, if applicable, or the deposit of Shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes and similar charges, and (iii) compliance with any U.S. or foreign laws or governmental regulations relating to the American Depositary Shares or to the withdrawal of the Deposited Securities.

The Depositary shall not knowingly accept for deposit under this Deposit Agreement any Shares that, at the time of deposit, are Restricted Securities or for which the Depositary has received written instructions from the Company that the deposit of those Shares would violate applicable law or regulation.

SECTION 2.7.    Lost Receipts, etc.

If a Receipt is mutilated, destroyed, lost or stolen, the Depositary shall deliver to the Owner the American Depositary Shares evidenced by that Receipt in uncertificated form or, if requested by the Owner, execute and deliver a new Receipt of like tenor in exchange and substitution for such mutilated Receipt, upon surrender and cancellation of that mutilated Receipt, or in lieu of and in substitution for that destroyed,

 

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lost or stolen Receipt. However, before the Depositary will deliver American Depositary Shares in uncertificated form or execute and deliver a new Receipt, in substitution for a destroyed, lost or stolen Receipt, the Owner must (a) file with the Depositary (i) a request for that replacement before the Depositary has notice that the Receipt has been acquired by a bona fide purchaser and (ii) a sufficient indemnity bond and (b) satisfy any other reasonable requirements imposed by the Depositary.

SECTION 2.8.    Cancellation and Destruction of Surrendered Receipts.

The Depositary shall cancel all Receipts surrendered to it and is authorized to destroy Receipts so cancelled.

SECTION 2.9.    DTC Direct Registration System and Profile Modification System.

(a)    Notwithstanding the provisions of Section 2.4, the parties acknowledge that DTC’s Direct Registration System (“DRS”) and Profile Modification System (“Profile”) apply to the American Depositary Shares upon acceptance thereof to DRS by DTC. DRS is the system administered by DTC that facilitates interchange between registered holding of uncertificated securities and holding of security entitlements in those securities through DTC and a DTC participant. Profile is a required feature of DRS that allows a DTC participant, claiming to act on behalf of an Owner of American Depositary Shares, to direct the Depositary to register a transfer of those American Depositary Shares to DTC or its nominee and to deliver those American Depositary Shares to the DTC account of that DTC participant without receipt by the Depositary of prior authorization from the Owner to register that transfer.

(b)    In connection with DRS/Profile, the parties acknowledge that the Depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an Owner in requesting a registration of transfer and delivery as described in paragraph (a) above has the actual authority to act on behalf of that Owner (notwithstanding any requirements under the Uniform Commercial Code). For the avoidance of doubt, the provisions of Sections 5.3 and 5.8 apply to the matters arising from the use of the DRS/Profile. The parties agree that the Depositary’s reliance on and compliance with instructions received by the Depositary through the DRS/Profile system and otherwise in accordance with this Deposit Agreement shall not constitute negligence or bad faith on the part of the Depositary.

 

ARTICLE 3.

CERTAIN OBLIGATIONS OF OWNERS AND HOLDERS OF AMERICAN DEPOSITARY SHARES

SECTION 3.1.    Filing Proofs, Certificates and Other Information.

Any person presenting Shares for deposit or any Owner or Holder may be required from time to time to file with the Depositary or the Custodian such proof of

 

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citizenship or residence, exchange control approval, or such information relating to the registration on the books of the Company or the Foreign Registrar, if applicable, to execute such certificates and to make such representations and warranties, as the Depositary may deem necessary or proper. The Depositary may withhold the delivery or registration of transfer of American Depositary Shares, the distribution of any dividend or other distribution or of the proceeds thereof or the delivery of any Deposited Securities until that proof or other information is filed or those certificates are executed or those representations and warranties are made.

Upon the reasonable written request and at the expense of the Company, the Depositary shall, as promptly as practicable, provide to the Company copies or originals, if necessary or appropriate, of any proofs of citizenship or residence, taxpayer status, exchange control approval, information, certificate or other representations and warranties that the Depositary receives under this Section 3.1 from the Owner or Holder or any person presenting Shares for deposit, to the extent that disclosure is permitted under applicable law. Each Owner and Holder agrees to provide any information reasonably requested by the Depositary pursuant to this Section 3.1. Neither the Company nor the Depositary is responsible for monitoring the Owners’ or the Holders’ compliance with applicable laws and regulations or their legal right to acquire Shares or American Depositary Shares.

SECTION 3.2.    Liability of Owner for Taxes.

If any tax or other governmental charge shall become payable by the Custodian or the Depositary with respect to or in connection with any American Depositary Shares or any Deposited Securities represented by any American Depositary Shares or in connection with a transaction to which Section 4.8 applies, that tax or other governmental charge shall be payable by the Owner of those American Depositary Shares to the Depositary. The Depositary may refuse to register any transfer of those American Depositary Shares or any withdrawal of Deposited Securities represented by those American Depositary Shares until that payment is made, and may withhold any dividends or other distributions or the proceeds thereof, or may sell for the account of the Owner any part or all of the Deposited Securities represented by those American Depositary Shares and apply those dividends or other distributions or the net proceeds of any sale of that kind in payment of that tax or other governmental charge but, even after a sale of that kind, the Owner of those American Depositary Shares shall remain liable for any deficiency. The Depositary shall distribute any net proceeds of a sale made under this Section that are not used to pay taxes or governmental charges to the Owners entitled to them in accordance with Section 4.1. If the number of Shares represented by each American Depositary Share decreases as a result of a sale of Deposited Securities under this Section, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

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SECTION 3.3.    Warranties on Deposit of Shares.

Every person depositing Shares under this Deposit Agreement shall be deemed thereby to represent and warrant that those Shares and each certificate therefor, if applicable, are validly issued, fully paid and nonassessable and were not issued in violation of any preemptive or similar rights of the holders of outstanding securities of the Company and that the person making that deposit is duly authorized so to do. Every depositing person shall also be deemed to represent that the Shares, at the time of deposit, are not Restricted Securities. All representations and warranties deemed made under this Section shall survive the deposit of Shares and delivery of American Depositary Shares.

SECTION 3.4.    Disclosure of Interests.

When required in order to comply with applicable laws and regulations or the articles of association or similar document of the Company, the Company may from time to time request each Owner and Holder to provide to the Depositary information relating to: (a) the capacity in which it holds American Depositary Shares, (b) the identity of any Holders or other persons or entities then or previously interested in those American Depositary Shares and the nature of those interests and (c) any other matter where disclosure of such matter is, in the Company’s reasonable opinion, required for that compliance. Each Owner and Holder agrees to provide all information known to it in response to a request made pursuant to this Section. Each Holder consents to the disclosure by the Depositary and the Owner or any other Holder through which it holds American Depositary Shares, directly or indirectly, of all information responsive to a request made pursuant to this Section relating to that Holder that is known to that Owner or other Holder. The Depositary agrees to use reasonable efforts to comply with written instructions requesting that the Depositary forward any request authorized under this Section to the Owners and to forward to the Company any responses it receives in response to that request. The Depositary may charge the Company a fee and its expenses for complying with requests under this Section 3.4.

 

ARTICLE 4.

THE DEPOSITED SECURITIES

SECTION 4.1.    Cash Distributions.

Whenever the Depositary receives any cash dividend or other cash distribution on Deposited Securities, the Depositary shall, subject to the provisions of Section 4.5, convert that dividend or other distribution into Dollars and distribute the amount thus received (net of the fees and expenses of the Depositary as provided in Section 5.9) to the Owners entitled thereto, in proportion to the number of American Depositary Shares representing those Deposited Securities held by them respectively; provided, however, that if the Custodian or the Depositary shall be required to withhold and does withhold from that cash dividend or other cash distribution an amount on account of taxes or other governmental charges, the amount distributed to the Owners of the American Depositary Shares representing those Deposited Securities shall be reduced accordingly. However, the Depositary will not pay any Owner a fraction of one cent, but will round each Owner’s entitlement to the nearest whole cent.

 

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The Company or its agent will remit to the appropriate governmental agency in each applicable jurisdiction all amounts withheld and owing to such agency.

If a cash distribution would represent a return of all or substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may, after consultation with the Company to the extent practicable, require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that cash distribution. A distribution of that kind shall be a Termination Option Event.

SECTION 4.2.    Distributions Other Than Cash, Shares or Rights.

Subject to the provisions of Sections 4.11 and 5.9, whenever the Depositary receives any distribution other than a distribution described in Section 4.1, 4.3 or 4.4 on Deposited Securities (but not in exchange for or in conversion or in lieu of Deposited Securities), the Depositary shall cause the securities or property received by it to be distributed to the Owners entitled thereto, after deduction or upon payment of any fees and expenses of the Depositary and any taxes or other governmental charges, in proportion to the number of American Depositary Shares representing such Deposited Securities held by them respectively, in any manner that the Depositary deems equitable and practicable for accomplishing that distribution (which may be a distribution of depositary shares representing the securities received); provided, however, that if in the opinion of the Depositary such distribution cannot be made proportionately among the Owners entitled thereto, or if for any other reason (including, but not limited to, any requirement that the Company or the Depositary withhold an amount on account of taxes or other governmental charges or that securities received must be registered under the Securities Act of 1933 in order to be distributed to Owners or Holders) the Depositary deems such distribution not to be lawful and feasible, the Depositary may, after consultation with the Company to the extent practicable, adopt such other method as it may deem equitable and practicable for the purpose of effecting such distribution, including, but not limited to, the public or private sale of the securities or property thus received, or any part thereof, and distribution of the net proceeds of any such sale (net of the fees and expenses of the Depositary as provided in Section 5.9) to the Owners entitled thereto, all in the manner and subject to the conditions set forth in Section 4.1. The Depositary may withhold any distribution of securities under this Section 4.2 if it has not received satisfactory assurances from the Company that the distribution does not require registration under the Securities Act of 1933. The Depositary may sell, by public or private sale, an amount of securities or other property it would otherwise distribute under this Section 4.2 that is sufficient to pay its fees and expenses in respect of that distribution.

 

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If a distribution under this Section 4.2 would represent a return of all or substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that distribution. A distribution of that kind shall be a Termination Option Event.

SECTION 4.3.    Distributions in Shares.

Whenever the Depositary receives any distribution on Deposited Securities consisting of a dividend in, or free distribution of, Shares, the Depositary may, and, if so requested in writing by the Company, shall, deliver to the Owners entitled thereto, in proportion to the number of American Depositary Shares representing those Deposited Securities held by them respectively, an aggregate number of American Depositary Shares representing the amount of Shares received as that dividend or free distribution, subject to the terms and conditions of this Deposit Agreement with respect to the deposit of Shares and issuance of American Depositary Shares, including withholding of any tax or governmental charge as provided in Section 4.11 and payment of the fees and expenses of the Depositary as provided in Section 5.9 (and the Depositary may sell, by public or private sale, an amount of the Shares received (or American Depositary Shares representing those Shares) sufficient to pay its fees and expenses in respect of that distribution). In lieu of delivering fractional American Depositary Shares, the Depositary may sell the amount of Shares represented by the aggregate of those fractions (or American Depositary Shares representing those Shares) and distribute the net proceeds, all in the manner and subject to the conditions described in Section 4.1. If and to the extent that additional American Depositary Shares are not delivered and Shares or American Depositary Shares are not sold, each American Depositary Share shall thenceforth also represent the additional Shares distributed on the Deposited Securities represented thereby.

If the Company declares a distribution in which holders of Deposited Securities have a right to elect whether to receive cash, Shares or other securities or a combination of those things, or a right to elect to have a distribution sold on their behalf, the Depositary may, after consultation with the Company, make that right of election available for exercise by Owners in any manner the Depositary considers to be lawful and practical. As a condition of making a distribution election right available to Owners, the Depositary may require satisfactory assurances from the Company that doing so does not require registration of any securities under the Securities Act of 1933.

SECTION 4.4.    Rights.

(a)    If rights are granted to the Depositary in respect of deposited Shares to purchase additional Shares or other securities, the Company and the Depositary shall endeavor to consult as to the actions, if any, the Depositary should take in connection with that grant of rights. The Depositary may, to the extent deemed by it to be lawful and

 

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practical (i) if requested in writing by the Company, grant to all or certain Owners rights to instruct the Depositary to purchase the securities to which the rights relate and deliver those securities or American Depositary Shares representing those securities to Owners, (ii) if requested in writing by the Company, deliver the rights to or to the order of certain Owners, or (iii) sell the rights to the extent practicable and distribute the net proceeds of that sale to Owners entitled to those proceeds. To the extent rights are not exercised, delivered or disposed of under (i), (ii) or (iii) above, the Depositary shall permit the rights to lapse unexercised.

(b)    If the Depositary will act under (a)(i) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon instruction from an applicable Owner in the form the Depositary specified and upon payment by that Owner to the Depositary of an amount equal to the purchase price of the securities to be received upon the exercise of the rights, the Depositary shall, on behalf of that Owner, exercise the rights and purchase the securities. The purchased securities shall be delivered to, or as instructed by, the Depositary. The Depositary shall (i) deposit the purchased Shares under this Deposit Agreement and deliver American Depositary Shares representing those Shares to that Owner or (ii) deliver or cause the purchased Shares or other securities to be delivered to or to the order of that Owner. The Depositary will not act under (a)(i) above unless the offer and sale of the securities to which the rights relate are registered under the Securities Act of 1933 or the Depositary has received an opinion of United States counsel that is satisfactory to it to the effect that those securities may be sold and delivered to the applicable Owners without registration under the Securities Act of 1933.

(c)    If the Depositary will act under (a)(ii) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon (i) the request of an applicable Owner to deliver the rights allocable to the American Depositary Shares of that Owner to an account specified by that Owner to which the rights can be delivered and (ii) receipt of such documents as the Company and the Depositary agreed to require to comply with applicable law, the Depositary will deliver those rights as requested by that Owner.

(d)    If the Depositary will act under (a)(iii) above, the Depositary will use reasonable efforts to sell the rights in proportion to the number of American Depositary Shares held by the applicable Owners and pay the net proceeds to the Owners otherwise entitled to the rights that were sold, upon an averaged or other practical basis without regard to any distinctions among such Owners because of exchange restrictions or the date of delivery of any American Depositary Shares or otherwise.

(e)    Payment or deduction of the fees of the Depositary as provided in Section 5.9 and payment or deduction of the expenses of the Depositary and any applicable taxes or other governmental charges shall be conditions of any delivery of securities or payment of cash proceeds under this Section 4.4.

 

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(f)    The Depositary shall not be responsible for any failure to determine that it may be lawful or feasible to make rights available to or exercise rights on behalf of Owners in general or any Owner in particular, or to sell rights.

SECTION 4.5.    Conversion of Foreign Currency.

Whenever the Depositary or the Custodian receives foreign currency, by way of dividends or other distributions or the net proceeds from the sale of securities, property or rights, and if at the time of the receipt thereof the foreign currency so received can in the judgment of the Depositary be converted on a reasonable basis into Dollars and the resulting Dollars transferred to the United States, the Depositary shall convert or cause to be converted by sale or in any other manner that it may determine that foreign currency into Dollars, and those Dollars shall be distributed to the Owners entitled thereto. A cash distribution may be made upon an averaged or other practicable basis without regard to any distinctions among Owners based on exchange restrictions, the date of delivery of any American Depositary Shares or otherwise and shall be net of any expenses of conversion into Dollars incurred by the Depositary as provided in Section 5.9.

If a conversion of foreign currency or the repatriation or distribution of Dollars can be effected only with the approval or license of any government or agency thereof, the Depositary may, but will not be required to, file an application for that approval or license.

If the Depositary determines that in its judgment any foreign currency received by the Depositary or the Custodian is not convertible on a reasonable basis into Dollars transferable to the United States, or if any approval or license of any government or agency thereof that is required for such conversion is not filed or sought by the Depositary or is not obtained within a reasonable period as determined by the Depositary, the Depositary may distribute the foreign currency received by the Depositary to, or in its discretion may hold such foreign currency uninvested and without liability for interest thereon for the respective accounts of, the Owners entitled to receive the same.

If any conversion of foreign currency, in whole or in part, cannot be effected for distribution to some of the Owners entitled thereto, the Depositary may in its discretion make that conversion and distribution in Dollars to the extent practicable and permissible to the Owners entitled thereto and may distribute the balance of the foreign currency received by the Depositary to, or hold that balance uninvested and without liability for interest thereon for the account of, the Owners entitled thereto.

The Depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under this Deposit Agreement and the rate that the Depositary or its affiliate receives

 

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when buying or selling foreign currency for its own account. The Depositary makes no representation that the exchange rate used or obtained in any currency conversion under this Deposit Agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be determined will be the most favorable to Owners, subject to the Depositary’s obligations under Section 5.3. The methodology used to determine exchange rates used in currency conversions is available upon request.

SECTION 4.6.    Fixing of Record Date.

Whenever a cash dividend, cash distribution or any other distribution is made on Deposited Securities or rights to purchase Shares or other securities are issued with respect to Deposited Securities (which rights will be delivered to or exercised or sold on behalf of Owners in accordance with Section 4.4) or the Depositary receives notice that a distribution or issuance of that kind will be made, or whenever the Depositary receives notice that a meeting of holders of Shares will be held in respect of which the Company has requested the Depositary to send a notice under Section 4.7, or whenever the Depositary will assess a fee or charge against the Owners, or whenever the Depositary causes a change in the number of Shares that are represented by each American Depositary Share, or whenever the Depositary otherwise finds it necessary or convenient, the Depositary shall fix a record date, which shall be the same as, or as near as practicable to, any corresponding record date set by the Company with respect to Shares, (a) for the determination of the Owners (i) who shall be entitled to receive the benefit of that dividend or other distribution or those rights, (ii) who shall be entitled to give instructions for the exercise of voting rights at that meeting, (iii) who shall be responsible for that fee or charge or (iv) for any other purpose for which the record date was set, or (b) on or after which each American Depositary Share will represent the changed number of Shares. Subject to the provisions of Sections 4.1 through 4.5 and to the other terms and conditions of this Deposit Agreement, the Owners on a record date fixed by the Depositary shall be entitled to receive the amount distributable by the Depositary with respect to that dividend or other distribution or those rights or the net proceeds of sale thereof in proportion to the number of American Depositary Shares held by them respectively, to give voting instructions or to act in respect of the other matter for which that record date was fixed, or be responsible for that fee or charge, as the case may be.

SECTION 4.7.    Voting of Deposited Shares.

(a)    Upon receipt of notice of any meeting of holders of Shares at which holders of Shares will be entitled to vote, if requested in writing by the Company, the Depositary shall, as soon as practicable thereafter, Disseminate to the Owners a notice, the form of which shall be in the sole discretion of the Depositary, that shall contain (i) the information contained in the notice of meeting received by the Depositary, (ii) a statement that the Owners as of the close of business on a specified record date will be entitled, subject to any applicable provision of Australian law and of the articles of association or similar documents of the Company, to instruct the Depositary as to the exercise of the

 

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voting rights pertaining to the amount of Shares represented by their respective American Depositary Shares, (iii) a statement as to the manner in which those instructions may be given and (iv) the last date on which the Depositary will accept instructions (the “Instruction Cutoff Date”).

(b)    Upon the written request of an Owner of American Depositary Shares, as of the date of the request or, if a record date was specified by the Depositary, as of that record date, received on or before any Instruction Cutoff Date established by the Depositary, the Depositary may, and if the Depositary sent a notice under the preceding paragraph shall, endeavor, in so far as practicable, to vote or cause to be voted the amount of deposited Shares represented by those American Depositary Shares in accordance with the instructions set forth in that request. The Depositary shall not vote or attempt to exercise the right to vote that attaches to the deposited Shares other than in accordance with instructions given by Owners and received by the Depositary.

(c)    There can be no assurance that Owners generally or any Owner in particular will receive the notice described in paragraph (a) above in time to enable Owners to give instructions to the Depositary prior to the Instruction Cutoff Date.

(d)    In order to give Owners a reasonable opportunity to instruct the Depositary as to the exercise of voting rights relating to Shares, if the Company will request the Depositary to Disseminate a notice under paragraph (a) above, the Company shall give the Depositary notice of the meeting, details concerning the matters to be voted upon and copies of materials to be made available to holders of Shares in connection with the meeting not less than [45] days prior to the meeting date.

SECTION 4.8.    Tender and Exchange Offers; Redemption, Replacement or Cancellation of Deposited Securities.

(a)    The Depositary shall not tender any Deposited Securities in response to any voluntary cash tender offer, exchange offer or similar offer made to holders of Deposited Securities (a “Voluntary Offer”), except when instructed in writing to do so by an Owner surrendering American Depositary Shares and subject to any conditions or procedures the Depositary may require.

(b)    If the Depositary receives a written notice that Deposited Securities have been redeemed for cash or otherwise purchased for cash in a transaction that is mandatory and binding on the Depositary as a holder of those Deposited Securities (a “Redemption”), the Depositary, at the expense of the Company, shall (i) if required, surrender Deposited Securities that have been redeemed to the issuer of those securities or its agent on the redemption date, (ii) Disseminate a notice to Owners (A) notifying them of that Redemption, (B) calling for surrender of a corresponding number of American Depositary Shares and (C) notifying them that the called American Depositary Shares have been converted into a right only to receive the money received by the Depositary upon that Redemption and those net proceeds shall be the Deposited Securities to which Owners of

 

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those converted American Depositary Shares shall be entitled upon surrenders of those American Depositary Shares in accordance with Section 2.5 or 6.2 and (iii) distribute the money received upon that Redemption to the Owners entitled to it upon surrender by them of called American Depositary Shares in accordance with Section 2.5 (and, for the avoidance of doubt, Owners shall not be entitled to receive that money under Section 4.1). If the Redemption affects less than all the Deposited Securities, the Depositary shall call for surrender a corresponding portion of the outstanding American Depositary Shares and only those American Depositary Shares will automatically be converted into a right to receive the net proceeds of the Redemption. The Depositary shall allocate the American Depositary Shares converted under the preceding sentence among the Owners pro-rata to their respective holdings of American Depositary Shares immediately prior to the Redemption, except that the allocations may be adjusted so that no fraction of a converted American Depositary Share is allocated to any Owner. A Redemption of all or substantially all of the Deposited Securities shall be a Termination Option Event.

(c)    If the Depositary is notified of or there occurs any change in nominal value or any subdivision, combination or any other reclassification of the Deposited Securities or any recapitalization, reorganization, sale of assets substantially as an entirety, merger or consolidation affecting the issuer of the Deposited Securities or to which it is a party that is mandatory and binding on the Depositary as a holder of Deposited Securities and, as a result, securities or other property have been or will be delivered in exchange, conversion, replacement or in lieu of, Deposited Securities (a “Replacement”), the Depositary shall, if required, surrender the old Deposited Securities affected by that Replacement of Shares and hold, as new Deposited Securities under this Deposit Agreement, the new securities or other property delivered to it in that Replacement. However, the Depositary may elect to sell those new Deposited Securities if in the opinion of the Depositary it is not lawful or not practical for it to hold those new Deposited Securities under this Deposit Agreement because those new Deposited Securities may not be distributed to Owners without registration under the Securities Act of 1933 or for any other reason, at public or private sale, at such places and on such terms as it deems proper and proceed as if those new Deposited Securities had been Redeemed under paragraph (b) above. A Replacement shall be a Termination Option Event.

(d)    In the case of a Replacement where the new Deposited Securities will continue to be held under this Deposit Agreement, the Depositary may call for the surrender of outstanding Receipts to be exchanged for new Receipts specifically describing the new Deposited Securities and the number of those new Deposited Securities represented by each American Depositary Share. If the number of Shares represented by each American Depositary Share decreases as a result of a Replacement, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

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(e)    If there are no Deposited Securities with respect to American Depositary Shares, including if the Deposited Securities are cancelled, or the Deposited Securities with respect to American Depositary Shares have become apparently worthless, the Depositary may call for surrender of those American Depositary Shares or may cancel those American Depositary Shares, upon notice to Owners, and that condition shall be a Termination Option Event.

SECTION 4.9.    Reports.

The Depositary shall make available for inspection by Owners at its Office any reports and communications, including any proxy solicitation material, received from the Company which are both (a) received by the Depositary as the holder of the Deposited Securities and (b) made generally available to the holders of those Deposited Securities by the Company. The Company shall furnish reports and communications, including any proxy soliciting material to which this Section applies, to the Depositary in English, to the extent those materials are required to be translated into English pursuant to any regulations of the Commission.

SECTION 4.10.    Lists of Owners.

Upon written request by the Company, the Depositary shall, at the expense of the Company, furnish to it a list, as of a recent date, of the names, addresses and American Depositary Share holdings of all Owners.

SECTION 4.11.    Withholding.

If the Depositary determines that any distribution received or to be made by the Depositary (including Shares and rights to subscribe therefor) is subject to any tax or other governmental charge that the Depositary is obligated to withhold, the Depositary may sell, by public or private sale, all or a portion of the distributed property (including Shares and rights to subscribe therefor) in the amounts and manner the Depositary deems necessary and practicable to pay those taxes or charges, and the Depositary shall distribute the net proceeds of that sale, after deduction of those taxes or charges, to the Owners entitled thereto in proportion to the number of American Depositary Shares held by them respectively.

Services for Owners and Holders that may permit them to obtain reduced rates of tax withholding at source or reclaim excess tax withheld, and the fees and costs associated with using services of that kind, are not provided under, and are outside the scope of, this Deposit Agreement.

Each Owner and Holder agrees to indemnify the Company, the Depositary, the Custodian and their respective directors, employees, agents and affiliates for, and hold each of them harmless against, any claim by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced withholding at source or other tax benefit received by it.

 

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The Depositary shall, to the extent required by U.S. law, report to the Owners any taxes or governmental charges withheld from or paid out of a distribution on Deposited Securities by it, the Custodian or, to the extent such information is received from the Company, the Company.

ARTICLE 5.    THE DEPOSITARY, THE CUSTODIANS AND THE COMPANY

SECTION 5.1.    Maintenance of Office and Transfer Books by the Depositary.

Until termination of this Deposit Agreement in accordance with its terms, the Depositary shall maintain facilities for the execution and delivery, registration, registration of transfers and surrender of American Depositary Shares in accordance with the provisions of this Deposit Agreement.

The Depositary shall keep books for the registration of American Depositary Shares, which shall be open for inspection by the Owners at the Depositary’s Office during regular business hours, provided that such inspection is not for the purpose of communicating with Owners in the interest of a business or object other than the business of the Company or a matter related to this Deposit Agreement or the American Depositary Shares.

The Depositary may close the transfer books, at any time or from time to time, when deemed expedient by it in connection with the performance of its duties under this Deposit Agreement.

If any American Depositary Shares are listed on one or more stock exchanges, the Depositary shall act as Registrar or appoint a Registrar or one or more co-registrars for registry of those American Depositary Shares in accordance with any requirements of that exchange or those exchanges.

The Company shall have the right, at all reasonable times, to inspect the transfer and registration records of the Depositary relating to the American Depositary Shares, to make copies thereof and to request the Depositary in writing to supply, at the Company’s expense, copies of such portions of such records as the Company may reasonably request.

SECTION 5.2.    Prevention or Delay of Performance by the Company or the Depositary.

Neither the Depositary nor the Company nor any of their respective directors, employees, agents or affiliates shall incur any liability to any Owner or Holder:

 

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(i) if by reason of (A) any provision of any present or future law or regulation or other act of the government of the United States, any State of the United States or any other state or jurisdiction, or of any governmental or regulatory authority or stock exchange; (B) (in the case of the Depositary only) any provision, present or future, of the articles of association or similar document of the Company, or any provision of any securities issued or distributed by the Company, or any offering or distribution thereof; or (C) any event or circumstance, whether natural or caused by a person or persons, that is beyond the ability of the Depositary or the Company, as the case may be, to prevent or counteract by reasonable care or effort (including, but not limited to, earthquakes, floods, severe storms, fires, explosions, war, terrorism, civil unrest, labor disputes or criminal acts; interruptions or malfunctions of utility services, Internet or other communications lines or systems; unauthorized access to or attacks on computer systems or websites; or other failures or malfunctions of computer hardware or software or other systems or equipment), the Depositary or the Company is, directly or indirectly, prevented from, forbidden to or delayed in, or could be subject to any civil or criminal penalty on account of doing or performing and therefore does not do or perform, any act or thing that, by the terms of this Deposit Agreement or the Deposited Securities, it is provided shall be done or performed;

(ii) for any exercise of, or failure to exercise, any discretion provided for in this Deposit Agreement (including any determination by the Depositary to take, or not take, any action that this Deposit Agreement provides the Depositary may take);

(iii) for the inability of any Owner or Holder to benefit from any distribution, offering, right or other benefit that is made available to holders of Deposited Securities but is not, under the terms of this Deposit Agreement, made available to Owners or Holders; or

(iv) for any special, consequential or punitive damages for any breach of the terms of this Deposit Agreement.

Where, by the terms of a distribution to which Section 4.1, 4.2 or 4.3 applies, or an offering to which Section 4.4 applies, or for any other reason, that distribution or offering may not be made available to Owners, and the Depositary may not dispose of that distribution or offering on behalf of Owners and make the net proceeds available to Owners, then the Depositary shall not make that distribution or offering available to Owners, and shall allow any rights, if applicable, to lapse.

SECTION 5.3.    Obligations of the Depositary and the Company.

Neither the Company nor any of its directors, officers, employees, agents controlling persons or affiliates assumes any obligation nor shall any of them be subject to any liability under this Deposit Agreement to any Owner or Holder, except that the Company agrees to perform its obligations specifically set forth in this Deposit Agreement without negligence or bad faith.

 

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Neither the Depositary nor any of its directors, officers, employees, agents controlling persons or affiliates assumes any obligation nor shall any of them be subject to any liability under this Deposit Agreement to any Owner or Holder (including, without limitation, liability with respect to the validity or worth of the Deposited Securities), except that the Depositary agrees to perform its obligations specifically set forth in this Deposit Agreement without negligence or bad faith, and the Depositary shall not be a fiduciary or have any fiduciary duty to Owners or Holders.

Neither the Depositary nor the Company nor any of their respective directors, officers, employees, agents controlling persons or affiliates shall be under any obligation to appear in, prosecute or defend any action, suit or other proceeding in respect of any Deposited Securities or in respect of the American Depositary Shares on behalf of any Owner or Holder or any other person.

Each of the Depositary and the Company may rely, and shall be protected in relying upon, any written notice, request, direction or other document believed by it to be genuine and to have been signed or presented by the proper party or parties.

Neither the Depositary nor the Company nor any of their directors, officers, employees, agents controlling persons or affiliates shall be liable for any action or non-action by it in reliance upon the advice of or information from legal counsel, accountants, any person presenting Shares for deposit, any Owner or any other person believed by it in good faith to be competent to give such advice or information.

The Depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the Depositary or in connection with any matter arising wholly after the removal or resignation of the Depositary, provided that in connection with the issue out of which such potential liability arises the Depositary performed its obligations without negligence or bad faith while it acted as Depositary.

Neither the Company nor the Depositary shall be liable for the acts or omissions of any securities depository, clearing agency or settlement system in connection with or arising out of book-entry settlement of American Depositary Shares or Deposited Securities or otherwise.

In the absence of bad faith on its part, the Depositary shall not be responsible for any failure to carry out any instructions to vote any of the Deposited Securities, or for the manner in which any such vote is cast or the effect of any such vote.

The Depositary shall have no duty to make any determination or provide any information as to the tax status of the Company or any liability for any tax consequences that may be incurred by Owners or Holders as a result of owning or holding American Depositary Shares. The Depositary shall not be liable for the inability or failure of an Owner or Holder to obtain the benefit of a foreign tax credit, reduced rate of withholding or refund of amounts withheld in respect of tax or any other tax benefit.

 

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No disclaimer of liability under the United States federal securities laws is intended by any provision of this Deposit Agreement.

SECTION 5.4.    Resignation and Removal of the Depositary.

The Depositary may at any time resign as Depositary hereunder by written notice of its election so to do delivered to the Company, to become effective upon the appointment of a successor depositary and its acceptance of that appointment as provided in this Section. The effect of resignation if a successor depositary is not appointed is provided for in Section 6.2.

The Depositary may at any time be removed by the Company by 90 days’ prior written notice of that removal, to become effective upon the later of (i) the 90th day after delivery of the notice to the Depositary and (ii) the appointment of a successor depositary and its acceptance of its appointment as provided in this Section.

If the Depositary resigns or is removed, the Company shall use its best efforts to appoint a successor depositary, which shall be a bank or trust company having an office in the Borough of Manhattan, The City of New York. Every successor depositary shall execute and deliver to the Company an instrument in writing accepting its appointment under this Deposit Agreement. If the Depositary receives notice from the Company that a successor depositary has been appointed following its resignation or removal, the Depositary, upon payment of all sums due it from the Company, shall deliver to its successor a register listing all the Owners and their respective holdings of outstanding American Depositary Shares and shall deliver the Deposited Securities to or to the order of its successor. When the Depositary has taken the actions specified in the preceding sentence (i) the successor shall become the Depositary and shall have all the rights and shall assume all the duties of the Depositary under this Deposit Agreement and (ii) the predecessor depositary shall cease to be the Depositary and shall be discharged and released from all obligations under this Deposit Agreement, except for its duties under Section 5.8 with respect to the time before that discharge. A successor Depositary shall notify the Owners of its appointment as soon as practical after assuming the duties of Depositary.

Any corporation or other entity into or with which the Depositary may be merged or consolidated shall be the successor of the Depositary without the execution or filing of any document or any further act.

SECTION 5.5.    The Custodians.

The Custodian shall be subject at all times and in all respects to the directions of the Depositary and shall be responsible solely to it. The Depositary in its

 

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discretion may at any time appoint a substitute or additional custodian or custodians, each of which shall thereafter be one of the Custodians under this Deposit Agreement. If the Depositary receives notice that a Custodian is resigning and, upon the effectiveness of that resignation there would be no Custodian acting under this Deposit Agreement, the Depositary shall, as promptly as practicable after receiving that notice, appoint a substitute custodian or custodians, each of which shall thereafter be a Custodian under this Deposit Agreement. The Depositary shall require any Custodian that resigns or is removed to deliver all Deposited Securities held by it to another Custodian.

SECTION 5.6.    Notices and Reports.

If the Company takes or decides to take any corporate action of a kind that is addressed in Sections 4.1 to 4.4, or 4.6 to 4.8, or that effects or will effect a change of the name or legal structure of the Company, or that effects or will effect a change to the Shares, the Company shall notify the Depositary and the Custodian of that action or decision as soon as it is lawful and practical to give that notice. The notice shall be in English and shall include all details that the Company is required to include in any notice to any governmental or regulatory authority or securities exchange or is required to make available generally to holders of Shares by publication or otherwise.

The Company will arrange for the translation into English, if not already in English, to the extent required pursuant to any regulations of the Commission, and the prompt transmittal by the Company to the Depositary and the Custodian of all notices and any other reports and communications which are made generally available by the Company to holders of its Shares. If requested in writing by the Company, the Depositary will Disseminate, at the Company’s expense, those notices, reports and communications to all Owners or otherwise make them available to Owners in a manner that the Company specifies as substantially equivalent to the manner in which those communications are made available to holders of Shares and compliant with the requirements of any securities exchange on which the American Depositary Shares are listed. The Company will timely provide the Depositary with the quantity of such notices, reports, and communications, as requested by the Depositary from time to time, in order for the Depositary to effect that Dissemination.

The Company represents that as of the date of this Deposit Agreement, the statements in Article 11 of the Receipt with respect to the Company’s obligation to file periodic reports under the United States Securities Exchange Act of 1934, as amended, are true and correct. The Company agrees to promptly notify the Depositary upon becoming aware of any change in the truth of any of those statements.

SECTION 5.7.    Distribution of Additional Shares, Rights, etc.

If the Company or any affiliate of the Company determines to make any issuance or distribution of (1) additional Shares, (2) rights to subscribe for Shares, (3) securities convertible into Shares, or (4) rights to subscribe for such securities (each a

 

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Distribution”), the Company shall notify the Depositary in writing in English as promptly as practicable and in any event before the Distribution starts and, if requested in writing by the Depositary, the Company shall promptly furnish to the Depositary either (i) evidence reasonably satisfactory to the Depositary that the Distribution is registered under the Securities Act of 1933 or (ii) a written opinion from U.S. counsel for the Company that is reasonably satisfactory to the Depositary, stating that the Distribution does not require, or, if made in the United States, would not require, registration under the Securities Act of 1933.

The Company agrees with the Depositary that neither the Company nor any company controlled by, controlling or under common control with the Company will at any time deposit any Shares that, at the time of deposit, are Restricted Securities.

Nothing in this Deposit Agreement shall create any obligation of the part of the Company to file a registration statement under the Securities Act of 1933 with respect to any Distribution. To the extent the Company in its sole discretion deems it necessary or advisable in order to avoid any requirement to register securities under the Securities Act of 1933, it may prevent Owners in the United States from purchasing securities and may instruct the Depositary not to accept certain Shares reasonably identified in such instruction for desposit for such period of time following the issuance of such additional securities or to adopt such other specific measures as the Company may reasonably request.

SECTION 5.8.    Indemnification.

The Company agrees to indemnify the Depositary, its directors, employees, agents and affiliates and each Custodian against, and hold each of them harmless from, any liability or expense (including, but not limited to any fees and expenses incurred in seeking, enforcing or collecting such indemnity and the fees and expenses of counsel) that may arise out of or in connection with (a) any registration with the Commission of American Depositary Shares or Deposited Securities or the offer or sale thereof or (b) acts performed or omitted, pursuant to the provisions of or in connection with this Deposit Agreement and the American Depositary Shares, as the same may be amended, modified or supplemented from time to time, (i) by either the Depositary or a Custodian or their respective directors, employees, agents and affiliates, except for any liability or expense arising out of the negligence or bad faith of either of them, or (ii) by the Company or any of its directors, employees, agents and affiliates.

The indemnities contained in the preceding paragraph shall not extend to any Losses arising out of information relating to the Depositary or any Custodian, as the case may be, furnished in writing by the Depositary to the Company expressly for use in any registration statement, proxy statement, prospectus or preliminary prospectus or any other offering documents relating to the American Depositary Shares, the Shares or any other Deposited Securities (it being acknowledged that, as of the date of this Deposit Agreement, the Depositary has not furnished any information of that kind).

 

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The Depositary agrees to indemnify the Company, its directors, employees, agents and affiliates and hold them harmless from any liability or expense that may arise out of acts performed or omitted by the Depositary or any Custodian or their respective directors, employees, agents and affiliates due to their negligence or bad faith.

SECTION 5.9.    Charges of Depositary.

The following charges shall be incurred by any party depositing or withdrawing Shares or by any party surrendering American Depositary Shares or to whom American Depositary Shares are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by the Company or an exchange of stock regarding the American Depositary Shares or Deposited Securities or a delivery of American Depositary Shares pursuant to Section 4.3), or by Owners, as applicable: (1) taxes and other governmental charges, (2) such registration fees as may from time to time be in effect for the registration of transfers of Shares generally on the Share register of the Company or Foreign Registrar and applicable to transfers of Shares to or from the name of the Depositary or its nominee or the Custodian or its nominee on the making of deposits or withdrawals hereunder, (3) such cable (including SWIFT) and facsimile transmission fees and expenses as are expressly provided in this Deposit Agreement, (4) such expenses as are incurred by the Depositary in the conversion of foreign currency pursuant to Section 4.5, (5) a fee of $5.00 or less per 100 American Depositary Shares (or portion thereof) for the delivery of American Depositary Shares pursuant to Section 2.3, 4.3 or 4.4 and the surrender of American Depositary Shares pursuant to Section 2.5 or 6.2, (6) a fee of $.05 or less per American Depositary Share (or portion thereof) for any cash distribution made pursuant to this Deposit Agreement, including, but not limited to Sections 4.1 through 4.4 and Section 4.8, (7) a fee for the distribution of securities pursuant to Section 4.2 or of rights pursuant to Section 4.4 (where the Depositary will not exercise or sell those rights on behalf of Owners), such fee being in an amount equal to the fee for the execution and delivery of American Depositary Shares referred to above which would have been charged as a result of the deposit of such securities under this Deposit Agreement (for purposes of this item 7 treating all such securities as if they were Shares) but which securities are instead distributed by the Depositary to Owners, (8) in addition to any fee charged under item 6 above, a fee of $.05 or less per American Depositary Share (or portion thereof) per annum for depositary services, which will be payable as provided in item 9 below, and (9) any other charges payable by the Depositary or the Custodian, any of the Depositary’s or Custodian’s agents or the agents of the Depositary’s or Custodian’s agents, in connection with the servicing of Shares or other Deposited Securities (which charges shall be assessed against Owners as of the date or dates set by the Depositary in accordance with Section 4.6 and shall be payable at the sole discretion of the Depositary by billing those Owners for those charges or by deducting those charges from one or more cash dividends or other cash distributions).

 

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The Depositary may collect any of its fees by deduction from any cash distribution payable, or by selling a portion of any securities to be distributed, to Owners that are obligated to pay those fees.

In performing its duties under this Deposit Agreement, the Depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the Depositary and that may earn or share fees, spreads or commissions.

The Depositary may own and deal in any class of securities of the Company and its affiliates and in American Depositary Shares.

SECTION 5.10.    Retention of Depositary Documents.

The Depositary is authorized to destroy those documents, records, bills and other data compiled during the term of this Deposit Agreement at the times permitted by the laws or regulations governing the Depositary, unless the Company reasonably requests that such papers be turned over to the Company or to a successor Depositary.

SECTION 5.11.    Exclusivity.

Without prejudice to the Company’s rights under Section 5.4, the Company agrees not to appoint any other depositary for issuance of depositary shares, depositary receipts or any similar securities or instruments so long as The Bank of New York Mellon is acting as Depositary under this Deposit Agreement.

SECTION 5.12.    Information for Regulatory Compliance.

Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

ARTICLE 6.    AMENDMENT AND TERMINATION

SECTION 6.1.    Amendment.

The form of the Receipts and any provisions of this Deposit Agreement may at any time and from time to time be amended by agreement between the Company and the Depositary without the consent of Owners or Holders in any respect that they may deem necessary or desirable. Any amendment that would impose or increase any fees or charges (other than taxes and other governmental charges, registration fees, cable, telex or facsimile transmission costs, delivery costs or other such expenses), or that would otherwise prejudice any substantial existing right of Owners, shall, however, not become effective as to outstanding American Depositary Shares until the expiration of 30 days after notice of that amendment has been Disseminated to the Owners of outstanding American Depositary

 

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Shares. Every Owner and Holder, at the time any amendment so becomes effective, shall be deemed, by continuing to hold American Depositary Shares or any interest therein, to consent and agree to that amendment and to be bound by this Deposit Agreement as amended thereby. Upon the effectiveness of an amendment to the form of Receipt, including a change in the number of Shares represented by each American Depositary Share, the Depositary may call for surrender of Receipts to be replaced with new Receipts in the amended form or call for surrender of American Depositary Shares to effect that change of ratio. In no event shall any amendment impair the right of the Owner to surrender American Depositary Shares and receive delivery of the Deposited Securities represented thereby, except in order to comply with mandatory provisions of applicable law.

SECTION 6.2.    Termination.

(a)    The Company may initiate termination of this Deposit Agreement by notice to the Depositary. The Depositary may initiate termination of this Deposit Agreement if (i) at any time 60 days shall have expired after the Depositary delivered to the Company a written resignation notice and a successor depositary has not been appointed and accepted its appointment as provided in Section 5.4, (ii) an Insolvency Event or Delisting Event occurs with respect to the Company or (iii) a Termination Option Event has occurred or will occur. If termination of this Deposit Agreement is initiated, the Depositary shall Disseminate a notice of termination to the Owners of all American Depositary Shares then outstanding setting a date for termination (the “Termination Date”), which shall be at least 90 days after the date of that notice, and this Deposit Agreement shall terminate on that Termination Date.

(b)    After the Termination Date, the Company shall be discharged from all obligations under this Deposit Agreement except for its obligations to the Depositary under Sections 5.8 and 5.9.

(c)    At any time after the Termination Date, the Depositary may sell the Deposited Securities then held under this Deposit Agreement and may thereafter hold uninvested the net proceeds of any such sale, together with any other cash then held by it hereunder, unsegregated and without liability for interest, for the pro rata benefit of the Owners of American Depositary Shares that remain outstanding, and those Owners will be general creditors of the Depositary with respect to those net proceeds and that other cash. After making that sale, the Depositary shall be discharged from all obligations under this Deposit Agreement, except (i) to account for the net proceeds and other cash (after deducting, in each case, the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of such American Depositary Shares in accordance with the terms and conditions of this Deposit Agreement and any applicable taxes or governmental charges) and (ii) for its obligations under Section 5.8 and (iii) to act as provided in paragraph (d) below.

(d)    After the Termination Date, if any American Depositary Shares remain outstanding, the Depositary shall continue to receive dividends and other

 

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distributions pertaining to Deposited Securities (that have not been sold), may sell rights and other property as provided in this Deposit Agreement and shall deliver Deposited Securities (or sale proceeds) upon surrender of American Depositary Shares (after payment or upon deduction, in each case, of the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of those American Depositary Shares in accordance with the terms and conditions of this Deposit Agreement and any applicable taxes or governmental charges). After the Termination Date, the Depositary shall not accept deposits of Shares or deliver American Depositary Shares. After the Termination Date, (i) the Depositary may refuse to accept surrenders of American Depositary Shares for the purpose of withdrawal of Deposited Securities (that have not been sold) or reverse previously accepted surrenders of that kind that have not settled if in its judgment the requested withdrawal would interfere with its efforts to sell the Deposited Securities, (ii) the Depositary will not be required to deliver cash proceeds of the sale of Deposited Securities until all Deposited Securities have been sold and (iii) the Depositary may discontinue the registration of transfers of American Depositary Shares and suspend the distribution of dividends and other distributions on Deposited Securities to the Owners and need not give any further notices or perform any further acts under this Deposit Agreement except as provided in this Section.

ARTICLE 7.    MISCELLANEOUS

SECTION 7.1.    Counterparts; Signatures.

This Deposit Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of those counterparts shall constitute one and the same instrument. Copies of this Deposit Agreement shall be filed with the Depositary and the Custodians and shall be open to inspection by any Owner or Holder during regular business hours.

Any manual signature on this Deposit Agreement that is faxed, scanned or photocopied, and any electronic signature valid under the Electronic Signatures in Global and National Commerce Act, 15 U.S.C. § 7001, et. seq., shall for all purposes have the same validity, legal effect and admissibility in evidence as an original manual signature, and the parties hereby waive any objection to the contrary.

SECTION 7.2.    No Third Party Beneficiaries.

This Deposit Agreement is for the exclusive benefit of the Company, the Depositary, the Owners and the Holders and their respective successors and shall not be deemed to give any legal or equitable right, remedy or claim whatsoever to any other person.

 

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SECTION 7.3.    Severability.

In case any one or more of the provisions contained in this Deposit Agreement or in a Receipt should be or become invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained in this Deposit Agreement or that Receipt shall in no way be affected, prejudiced or disturbed thereby.

SECTION 7.4.    Owners and Holders as Parties; Binding Effect.

The Owners and Holders from time to time shall be parties to this Deposit Agreement and shall be bound by all of the terms and conditions of this Deposit Agreement and of the Receipts by acceptance of American Depositary Shares or any interest therein.

SECTION 7.5.    Notices.

Any and all notices to be given to the Company shall be in writing and shall be deemed to have been duly given if personally delivered or sent by domestic first class or international air mail or air courier or sent by facsimile transmission or email attaching a pdf or similar bit-mapped image of a signed writing, provided that receipt of the facsimile transmission or email has been confirmed by the recipient, addressed to Avita Medical Limited, 28159 Avenue Stanford, Suite 220 Valencia, CA, 91355, United States of America, Attention: General Counsel, or any other place to which the Company may have transferred its principal office with notice to the Depositary.

Any and all notices to be given to the Depositary shall be in writing and shall be deemed to have been duly given if in English and personally delivered or sent by first class domestic or international air mail or air courier or sent by facsimile transmission or email attaching a pdf or similar bit-mapped image of a signed writing, addressed to The Bank of New York Mellon, 240 Greenwich Street, New York, New York 10286, Attention: Depositary Receipt Administration, or any other place to which the Depositary may have transferred its Office with notice to the Company.

Delivery of a notice to the Company or Depositary by mail or air courier shall be deemed effected when deposited, postage prepaid, in a post-office letter box or received by an air courier service. Delivery of a notice to the Company or Depositary sent by facsimile transmission or email shall be deemed effected when the recipient acknowledges receipt of that notice.

A notice to be given to an Owner shall be deemed to have been duly given when Disseminated to that Owner. Dissemination in paper form will be effective when personally delivered or sent by first class domestic or international air mail or air courier, addressed to that Owner at the address of that Owner as it appears on the transfer books for American Depositary Shares of the Depositary, or, if that Owner has filed with the Depositary a written request that notices intended for that Owner be mailed to some other

 

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address, at the address designated in that request. Dissemination in electronic form will be effective when sent in the manner consented to by the Owner to the electronic address most recently provided by the Owner for that purpose.

SECTION 7.6.    Appointment of Agent for Service of Process; Submission to Jurisdiction; Jury Trial Waiver.

The Company hereby (i) designates and appoints the person named in Exhibit A to this Deposit Agreement, located in the State of New York, as the Company’s authorized agent upon which process may be served in any suit or proceeding arising out of or relating to the Shares or Deposited Securities, the American Depositary Shares, the Receipts or this Deposit Agreement (a “Proceeding”), (ii) consents and submits to the jurisdiction of any state or federal court in the State of New York in which any Proceeding may be instituted and (iii) agrees that service of process upon said authorized agent shall be deemed in every respect effective service of process upon the Company in any Proceeding. The Company agrees to deliver to the Depositary, upon the execution and delivery of this Deposit Agreement, a written acceptance by the agent named in Exhibit A to this Deposit Agreement of its appointment as process agent. The Company further agrees to take any and all action, including the filing of any and all such documents and instruments, as may be necessary to continue that designation and appointment in full force and effect, or to appoint and maintain the appointment of another process agent located in the United States as required above, and to deliver to the Depositary a written acceptance by that agent of that appointment, for so long as any American Depositary Shares or Receipts remain outstanding or this Deposit Agreement remains in force. In the event the Company fails to maintain the designation and appointment of a process agent in the United States in full force and effect, the Company hereby waives personal service of process upon it and consents that a service of process in connection with a Proceeding may be made by certified or registered mail, return receipt requested, directed to the Company at its address last specified for notices under this Deposit Agreement, and service so made shall be deemed completed five (5) days after the same shall have been so mailed.

EACH PARTY TO THIS DEPOSIT AGREEMENT (INCLUDING, FOR AVOIDANCE OF DOUBT, EACH OWNER AND HOLDER) HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING AGAINST THE COMPANY AND/OR THE DEPOSITARY DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THE SHARES OR OTHER DEPOSITED SECURITIES, THE AMERICAN DEPOSITARY SHARES OR THE RECEIPTS, THIS DEPOSIT AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREIN OR THEREIN, OR THE BREACH HEREOF OR THEREOF, INCLUDING, WITHOUT LIMITATION, ANY QUESTION REGARDING EXISTENCE, VALIDITY OR TERMINATION (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).

 

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SECTION 7.7.    Waiver of Immunities.

To the extent that the Company or any of its properties, assets or revenues may have or may hereafter become entitled to, or have attributed to it, any right of immunity, on the grounds of sovereignty or otherwise, from any legal action, suit or proceeding, from the giving of any relief in any respect thereof, from setoff or counterclaim, from the jurisdiction of any court, from service of process, from attachment upon or prior to judgment, from attachment in aid of execution or judgment, or from execution of judgment, or other legal process or proceeding for the giving of any relief or for the enforcement of any judgment, in any jurisdiction in which proceedings may at any time be commenced, with respect to its obligations, liabilities or any other matter under or arising out of or in connection with the Shares or Deposited Securities, the American Depositary Shares, the Receipts or this Deposit Agreement, the Company, to the fullest extent permitted by law, hereby irrevocably and unconditionally waives, and agrees not to plead or claim, any immunity of that kind and consents to relief and enforcement as provided above.

SECTION 7.8.    Governing Law.

This Deposit Agreement and the Receipts shall be interpreted in accordance with and all rights hereunder and thereunder and provisions hereof and thereof shall be governed by the laws of the State of New York.

 

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IN WITNESS WHEREOF, AVITA MEDICAL LIMITED and THE BANK OF NEW YORK MELLON have duly executed this Deposit Agreement as of the day and year first set forth above and all Owners and Holders shall become parties hereto upon acceptance by them of American Depositary Shares or any interest therein.

 

AVITA MEDICAL LIMITED
By:  

 

    Name:
    Title:

 

THE BANK OF NEW YORK MELLON,
as Depositary

By:  

 

    Name:
    Title:

 

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EXHIBIT A

AMERICAN DEPOSITARY SHARES

(Each American Depositary Share represents

Twenty (20) deposited Shares)

THE BANK OF NEW YORK MELLON

AMERICAN DEPOSITARY RECEIPT

FOR ORDINARY SHARES OF

AVITA MEDICAL LIMITED

(ABN 98 008 624 691)

(INCORPORATED UNDER THE LAWS OF THE COMMONWEALTH OF AUSTRALIA)

The Bank of New York Mellon, as depositary (hereinafter called the “Depositary”), hereby certifies that                         , or registered assigns IS THE OWNER OF                     

AMERICAN DEPOSITARY SHARES

representing deposited ordinary shares (herein called “Shares”) of Avita Medical Limited (ABN 98 008 624 691), incorporated under the laws of the Commonwealth of Australia (herein called the “Company”). At the date hereof, each American Depositary Share represents twenty (20) Shares deposited or subject to deposit under the Deposit Agreement (as such term is hereinafter defined) with a custodian for the Depositary (herein called the “Custodian”) that, as of the date of the Deposit Agreement, was National Australia bank Ltd located in Melbourne, Australia. The Depositary’s Office and its principal executive office are located at 240 Greenwich Street, New York, N.Y. 10286.

THE DEPOSITARY’S OFFICE ADDRESS IS

240 GREENWICH STREET, NEW YORK, N.Y. 10286

 

A-1


1.

THE DEPOSIT AGREEMENT.

This American Depositary Receipt is one of an issue (herein called “Receipts”), all issued and to be issued upon the terms and conditions set forth in the Amended and Restated Deposit Agreement dated as of                     , 2019 (herein called the “Deposit Agreement”) among the Company, the Depositary, and all Owners and Holders from time to time of American Depositary Shares issued thereunder, each of whom by accepting American Depositary Shares agrees to become a party thereto and become bound by all the terms and conditions thereof. The Deposit Agreement sets forth the rights of Owners and Holders and the rights and duties of the Depositary in respect of the Shares deposited thereunder and any and all other securities, property and cash from time to time received in respect of those Shares and held thereunder (those Shares, securities, property, and cash are herein called “Deposited Securities”). Copies of the Deposit Agreement are on file at the Depositary’s Office in New York City and at the office of the Custodian.

The statements made on the face and reverse of this Receipt are summaries of certain provisions of the Deposit Agreement and are qualified by and subject to the detailed provisions of the Deposit Agreement, to which reference is hereby made. Capitalized terms defined in the Deposit Agreement and not defined herein shall have the meanings set forth in the Deposit Agreement.

 

2.

SURRENDER OF AMERICAN DEPOSITARY SHARES AND WITHDRAWAL OF SHARES.

Upon surrender of American Depositary Shares for the purpose of withdrawal of the Deposited Securities represented thereby and payment of the fee of the Depositary for the surrender of American Depositary Shares as provided in Section 5.9 of the Deposit Agreement and payment of all taxes and governmental charges payable in connection with that surrender and withdrawal of the Deposited Securities, and subject to the terms and conditions of the Deposit Agreement, the Owner of those American Depositary Shares shall be entitled to delivery (to the extent delivery can then be lawfully and practicably made), to or as instructed by that Owner, of the amount of Deposited Securities at the time represented by those American Depositary Shares, but not any money or other property as to which a record date for distribution to Owners has passed (since money or other property of that kind will be delivered or paid on the scheduled payment date to the Owner as of that record date), and except that the Depositary shall not be required to accept surrender of American Depositary Shares for the purpose of withdrawal to the extent it would require delivery of a fraction of a Deposited Security. The Depositary shall direct the Custodian with respect to delivery of Deposited Securities and may charge the surrendering Owner a fee and its expenses for giving that direction by cable (including SWIFT) or facsimile transmission. If Deposited Securities are delivered physically upon surrender of American Depositary Shares for the purpose of withdrawal, that delivery will be made at the Custodian’s office, except that, at the request, risk and expense of the surrendering Owner, and for the account of that Owner, the Depositary shall direct the Custodian to forward any

 

A-2


cash or other property comprising, and forward a certificate or certificates, if applicable, and other proper documents of title, if any, for, the Deposited Securities represented by the surrendered American Depositary Shares to the Depositary for delivery at the Depositary’s Office or to another address specified in the order received from the surrendering Owner.

 

3.

REGISTRATION OF TRANSFER OF AMERICAN DEPOSITARY SHARES; COMBINATION AND SPLIT-UP OF RECEIPTS; INTERCHANGE OF CERTIFICATED AND UNCERTIFICATED AMERICAN DEPOSITARY SHARES.

The Depositary, subject to the terms and conditions of the Deposit Agreement, shall register a transfer of American Depositary Shares on its transfer books upon (i) in the case of certificated American Depositary Shares, surrender of the Receipt evidencing those American Depositary Shares, by the Owner or by a duly authorized attorney, properly endorsed or accompanied by proper instruments of transfer or (ii) in the case of uncertificated American Depositary Shares, receipt from the Owner of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9 of that Agreement), and, in either case, duly stamped as may be required by the laws of the State of New York and of the United States of America. Upon registration of a transfer, the Depositary shall deliver the transferred American Depositary Shares to or upon the order of the person entitled thereto.

The Depositary, subject to the terms and conditions of the Deposit Agreement, shall upon surrender of a Receipt or Receipts for the purpose of effecting a split-up or combination of such Receipt or Receipts, execute and deliver a new Receipt or Receipts for any authorized number of American Depositary Shares requested, evidencing the same aggregate number of American Depositary Shares as the Receipt or Receipts surrendered.

The Depositary, upon surrender of certificated American Depositary Shares for the purpose of exchanging for uncertificated American Depositary Shares, shall cancel the Receipt evidencing those certificated American Depositary Shares and send the Owner a statement confirming that the Owner is the owner of the same number of uncertificated American Depositary Shares. The Depositary, upon receipt of a proper instruction (including, for the avoidance of doubt, instructions through DRS and Profile as provided in Section 2.9 of the Deposit Agreement) from the Owner of uncertificated American Depositary Shares for the purpose of exchanging for certificated American Depositary Shares, shall cancel those uncertificated American Depositary Shares and register and deliver to the Owner a Receipt evidencing the same number of certificated American Depositary Shares.

As a condition precedent to the delivery, registration of transfer, or surrender of any American Depositary Shares or split-up or combination of any Receipt or withdrawal of any Deposited Securities, the Depositary, the Custodian, or Registrar may require payment from the depositor of the Shares or the presenter of the Receipt or instruction for registration of transfer or surrender of American Depositary Shares not evidenced by a

 

A-3


Receipt of a sum sufficient to reimburse it for any tax or other governmental charge and any stock transfer or registration fee with respect thereto (including any such tax or charge and fee with respect to Shares being deposited or withdrawn) and payment of any applicable fees as provided in the Deposit Agreement, may require the production of proof satisfactory to it as to the identity and genuineness of any signature and may also require compliance with any regulations the Depositary may establish consistent with the provisions of the Deposit Agreement.

The delivery of American Depositary Shares against deposit of Shares generally or against deposit of particular Shares may be suspended, or the registration of transfer of American Depositary Shares in particular instances may be refused, or the registration of transfer of outstanding American Depositary Shares generally may be suspended, during any period when the transfer books of the Depositary are closed, or if any such action is deemed necessary or advisable by the Depositary or the Company at any time or from time to time because of any requirement of law or of any government or governmental body or commission, or under any provision of the Deposit Agreement, or for any other reason. Notwithstanding anything to the contrary in the Deposit Agreement or this Receipt, the surrender of outstanding American Depositary Shares and withdrawal of Deposited Securities may not be suspended subject only to (i) temporary delays caused by closing the transfer books of the Depositary or the Company or the Foreign Registrar, if applicable, or the deposit of Shares in connection with voting at a shareholders’ meeting, or the payment of dividends, (ii) the payment of fees, taxes and similar charges, and (iii) compliance with any U.S. or foreign laws or governmental regulations relating to the American Depositary Shares or to the withdrawal of the Deposited Securities. The Depositary shall not knowingly accept for deposit under the Deposit Agreement any Shares that, at the time of deposit, are Restricted Securities.

 

4.

LIABILITY OF OWNER FOR TAXES.

If any tax or other governmental charge shall become payable by the Custodian or the Depositary with respect to or in connection with any American Depositary Shares or any Deposited Securities represented by any American Depositary Shares or in connection with a transaction to which Section 4.8 of the Deposit Agreement applies, that tax or other governmental charge shall be payable by the Owner of those American Depositary Shares to the Depositary. The Depositary may refuse to register any transfer of those American Depositary Shares or any withdrawal of Deposited Securities represented by those American Depositary Shares until that payment is made, and may withhold any dividends or other distributions or the proceeds thereof, or may sell for the account of the Owner any part or all of the Deposited Securities represented by those American Depositary Shares, and may apply those dividends or other distributions or the net proceeds of any sale of that kind in payment of that tax or other governmental charge but, even after a sale of that kind, the Owner shall remain liable for any deficiency. The Depositary shall distribute any net proceeds of a sale made under Section 3.2 of the Deposit Agreement that are not used to pay taxes or governmental charges to the Owners entitled to them in accordance with

 

A-4


Section 4.1 of the Deposit Agreement. If the number of Shares represented by each American Depositary Share decreases as a result of a sale of Deposited Securities under Section 3.2 of the Deposit Agreement, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

 

5.

WARRANTIES ON DEPOSIT OF SHARES.

Every person depositing Shares under the Deposit Agreement shall be deemed thereby to represent and warrant that those Shares and each certificate therefor, if applicable, are validly issued, fully paid and nonassessable and were not issued in violation of any preemptive or similar rights of the holders of outstanding securities of the Company and that the person making that deposit is duly authorized so to do. Every depositing person shall also be deemed to represent that the Shares, at the time of deposit, are not Restricted Securities. All representations and warranties deemed made under Section 3.3 of the Deposit Agreement shall survive the deposit of Shares and delivery of American Depositary Shares.

 

6.

FILING PROOFS, CERTIFICATES, AND OTHER INFORMATION.

Any person presenting Shares for deposit or any Owner or Holder may be required from time to time to file with the Depositary or the Custodian such proof of citizenship or residence, exchange control approval, or such information relating to the registration on the books of the Company or the Foreign Registrar, if applicable, to execute such certificates and to make such representations and warranties, as the Depositary may deem necessary or proper. The Depositary may withhold the delivery or registration of transfer of any American Depositary Shares, the distribution of any dividend or other distribution or of the proceeds thereof or the delivery of any Deposited Securities until that proof or other information is filed or those certificates are executed or those representations and warranties are made. As conditions of accepting Shares for deposit, the Depositary may require (i) any certification required by the Depositary or the Custodian in accordance with the provisions of the Deposit Agreement, (ii) a written order directing the Depositary to deliver to, or upon the written order of, the person or persons stated in that order, the number of American Depositary Shares representing those Deposited Shares, (iii) evidence satisfactory to the Depositary that those Shares have been re-registered in the books of the Company or the Foreign Registrar in the name of the Depositary, a Custodian or a nominee of the Depositary or a Custodian, (iv) evidence satisfactory to the Depositary that any necessary approval has been granted by any governmental body in each applicable jurisdiction and (v) an agreement or assignment, or other instrument satisfactory to the Depositary, that provides for the prompt transfer to the Custodian of any dividend, or right to subscribe for additional Shares or to receive other property, that any person in whose name those Shares are or have been recorded may thereafter receive upon or in respect of those Shares, or, in lieu thereof, such agreement of indemnity or other agreement as shall be satisfactory to the Depositary.

 

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7.

CHARGES OF DEPOSITARY.

The following charges shall be incurred by any party depositing or withdrawing Shares or by any party surrendering American Depositary Shares or to whom American Depositary Shares are issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by the Company or an exchange of stock regarding the American Depositary Shares or Deposited Securities or a delivery of American Depositary Shares pursuant to Section 4.3 of the Deposit Agreement), or by Owners, as applicable: (1) taxes and other governmental charges, (2) such registration fees as may from time to time be in effect for the registration of transfers of Shares generally on the Share register of the Company or Foreign Registrar and applicable to transfers of Shares to or from the name of the Depositary or its nominee or the Custodian or its nominee on the making of deposits or withdrawals hereunder, (3) such cable (including SWIFT) and facsimile transmission fees and expenses as are expressly provided in the Deposit Agreement, (4) such expenses as are incurred by the Depositary in the conversion of foreign currency pursuant to Section 4.5 of the Deposit Agreement, (5) a fee of $5.00 or less per 100 American Depositary Shares (or portion thereof) for the delivery of American Depositary Shares pursuant to Section 2.3, 4.3 or 4.4 of the Deposit Agreement and the surrender of American Depositary Shares pursuant to Section 2.5 or 6.2 of the Deposit Agreement, (6) a fee of $.05 or less per American Depositary Share (or portion thereof) for any cash distribution made pursuant to the Deposit Agreement, including, but not limited to Sections 4.1 through 4.4 and 4.8 of the Deposit Agreement, (7) a fee for the distribution of securities pursuant to Section 4.2 of the Deposit Agreement or of rights pursuant to Section 4.4 of that Agreement (where the Depositary will not exercise or sell those rights on behalf of Owners), such fee being in an amount equal to the fee for the execution and delivery of American Depositary Shares referred to above which would have been charged as a result of the deposit of such securities under the Deposit Agreement (for purposes of this item 7 treating all such securities as if they were Shares) but which securities are instead distributed by the Depositary to Owners, (8) in addition to any fee charged under item 6, a fee of $.05 or less per American Depositary Share (or portion thereof) per annum for depositary services, which will be payable as provided in item 9 below, and (9) any other charges payable by the Depositary or the Custodian, any of the Depositary’s or Custodian’s agents or the agents of the Depositary’s or Custodian’s agents, in connection with the servicing of Shares or other Deposited Securities (which charges shall be assessed against Owners as of the date or dates set by the Depositary in accordance with Section 4.6 of the Deposit Agreement and shall be payable at the sole discretion of the Depositary by billing those Owners for those charges or by deducting those charges from one or more cash dividends or other cash distributions).

 

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The Depositary may collect any of its fees by deduction from any cash distribution payable, or by selling a portion of any securities to be distributed, to Owners that are obligated to pay those fees.

The Depositary may own and deal in any class of securities of the Company and its affiliates and in American Depositary Shares.

From time to time, the Depositary may make payments to the Company to reimburse the Company for costs and expenses generally arising out of establishment and maintenance of the American Depositary Shares program, waive fees and expenses for services provided by the Depositary or share revenue from the fees collected from Owners or Holders. In performing its duties under the Deposit Agreement, the Depositary may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the Depositary and that may earn or share fees, spreads or commissions.

 

8.

DISCLOSURE OF INTERESTS.

When required in order to comply with applicable laws and regulations or the articles of association or similar document of the Company, the Company may from time to time request each Owner and Holder to provide to the Depositary information relating to: (a) the capacity in which it holds American Depositary Shares, (b) the identity of any Holders or other persons or entities then or previously interested in those American Depositary Shares and the nature of those interests and (c) any other matter where disclosure of such matter is, in the Company’s reasonable opinion, required for that compliance. Each Owner and Holder agrees to provide all information known to it in response to a request made pursuant to Section 3.4 of the Deposit Agreement. Each Holder consents to the disclosure by the Depositary and the Owner or other Holder through which it holds American Depositary Shares, directly or indirectly, of all information responsive to a request made pursuant to that Section relating to that Holder that is known to that Owner or other Holder.

 

9.

TITLE TO AMERICAN DEPOSITARY SHARES.

It is a condition of the American Depositary Shares, and every successive Owner and Holder of American Depositary Shares, by accepting or holding the same, consents and agrees that American Depositary Shares evidenced by a Receipt, when the Receipt is properly endorsed or accompanied by proper instruments of transfer, shall be transferable as certificated registered securities under the laws of the State of New York, and that American Depositary Shares not evidenced by Receipts shall be transferable as uncertificated registered securities under the laws of the State of New York. The Depositary, notwithstanding any notice to the contrary, may treat the Owner of American Depositary Shares as the absolute owner thereof for the purpose of determining the person entitled to distribution of dividends or other distributions or to any notice provided for in the Deposit Agreement and for all other purposes, and neither the Depositary nor the Company shall have any obligation or be subject to any liability under the Deposit Agreement to any Holder of American Depositary Shares, but only to the Owner.

 

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10.

VALIDITY OF RECEIPT.

This Receipt shall not be entitled to any benefits under the Deposit Agreement or be valid or obligatory for any purpose, unless this Receipt shall have been (i) executed by the Depositary by the manual signature of a duly authorized officer of the Depositary or (ii) executed by the facsimile signature of a duly authorized officer of the Depositary and countersigned by the manual signature of a duly authorized signatory of the Depositary or the Registrar or a co-registrar.

 

11.

REPORTS; INSPECTION OF TRANSFER BOOKS.

The Company is subject to the periodic reporting requirements of the Securities Exchange Act of 1934 and, accordingly, files certain reports with the Securities and Exchange Commission. Those reports will be available for inspection and copying through the Commission’s EDGAR system or at public reference facilities maintained by the Commission in Washington, D.C.

The Depositary will make available for inspection by Owners at its Office any reports, notices and other communications, including any proxy soliciting material, received from the Company which are both (a) received by the Depositary as the holder of the Deposited Securities and (b) made generally available to the holders of those Deposited Securities by the Company. The Company shall furnish reports and communications, including any proxy soliciting material to which Section 4.9 of the Deposit Agreement applies, to the Depositary in English, to the extent such materials are required to be translated into English pursuant to any regulations of the Commission.

The Depositary will keep books for the registration of American Depositary Shares and transfers of American Depositary Shares, which shall be open for inspection by the Owners at the Depositary’s Office during regular business hours, provided that such inspection shall not be for the purpose of communicating with Owners in the interest of a business or object other than the business of the Company or a matter related to the Deposit Agreement or the American Depositary Shares.

 

12.

DIVIDENDS AND DISTRIBUTIONS.

Whenever the Depositary receives any cash dividend or other cash distribution on Deposited Securities, the Depositary will, if at the time of receipt thereof any amounts received in a foreign currency can in the judgment of the Depositary be converted on a reasonable basis into Dollars transferable to the United States, and subject to the Deposit Agreement, convert that dividend or other cash distribution into Dollars and distribute the amount thus received (net of the fees and expenses of the Depositary as provided in Article 7 hereof and Section 5.9 of the Deposit Agreement) to the Owners entitled thereto;

 

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provided, however, that if the Custodian or the Depositary is required to withhold and does withhold from that cash dividend or other cash distribution an amount on account of taxes or other governmental charges, the amount distributed to the Owners of the American Depositary Shares representing those Deposited Securities shall be reduced accordingly. If a cash distribution would represent a return of all or substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that cash distribution. A distribution of that kind shall be a Termination Option Event.

Subject to the provisions of Section 4.11 and 5.9 of the Deposit Agreement, whenever the Depositary receives any distribution other than a distribution described in Section 4.1, 4.3 or 4.4 of the Deposit Agreement on Deposited Securities (but not in exchange for or in conversion or in lieu of Deposited Securities), the Depositary will cause the securities or property received by it to be distributed to the Owners entitled thereto, after deduction or upon payment of any fees and expenses of the Depositary and any taxes or other governmental charges, in any manner that the Depositary deems equitable and practicable for accomplishing that distribution (which may be a distribution of depositary shares representing the securities received); provided, however, that if in the opinion of the Depositary such distribution cannot be made proportionately among the Owners entitled thereto, or if for any other reason the Depositary deems such distribution not to be lawful and feasible, the Depositary may, after consultation with the Company to the extent practicable, adopt such other method as it may deem equitable and practicable for the purpose of effecting such distribution, including, but not limited to, the public or private sale of the securities or property thus received, or any part thereof, and distribution of the net proceeds of any such sale (net of the fees and expenses of the Depositary as provided in Article 7 hereof and Section 5.9 of the Deposit Agreement) to the Owners entitled thereto all in the manner and subject to the conditions set forth in Section 4.1 of the Deposit Agreement. The Depositary may withhold any distribution of securities under Section 4.2 of the Deposit Agreement if it has not received satisfactory assurances from the Company that the distribution does not require registration under the Securities Act of 1933. The Depositary may sell, by public or private sale, an amount of securities or other property it would otherwise distribute under this Article that is sufficient to pay its fees and expenses in respect of that distribution. If a distribution under Section 4.2 of the Deposit Agreement would represent a return of all of substantially all the value of the Deposited Securities underlying American Depositary Shares, the Depositary may require surrender of those American Depositary Shares and may require payment of or deduct the fee for surrender of American Depositary Shares (whether or not it is also requiring surrender of American Depositary Shares) as a condition of making that distribution. A distribution of that kind shall be a Termination Option Event.

Whenever the Depositary receives any distribution consisting of a dividend in, or free distribution of, Shares, the Depositary may, and, if so requested in writing by the

 

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Company, shall, deliver to the Owners entitled thereto, an aggregate number of American Depositary Shares representing the amount of Shares received as that dividend or free distribution, subject to the terms and conditions of the Deposit Agreement with respect to the deposit of Shares and issuance of American Depositary Shares, including the withholding of any tax or other governmental charge as provided in Section 4.11 of the Deposit Agreement and the payment of the fees and expenses of the Depositary as provided in Article 7 hereof and Section 5.9 of the Deposit Agreement (and the Depositary may sell, by public or private sale, an amount of Shares received (or American Depositary Shares representing those Shares) sufficient to pay its fees and expenses in respect of that distribution). In lieu of delivering fractional American Depositary Shares, the Depositary may sell the amount of Shares represented by the aggregate of those fractions (or American Depositary Shares representing those Shares) and distribute the net proceeds, all in the manner and subject to the conditions described in Section 4.1 of the Deposit Agreement. If and to the extent that additional American Depositary Shares are not delivered and Shares or American Depositary Shares are not sold, each American Depositary Share shall thenceforth also represent the additional Shares distributed on the Deposited Securities represented thereby.

If the Company declares a distribution in which holders of Deposited Securities have a right to elect whether to receive cash, Shares or other securities or a combination of those things, or a right to elect to have a distribution sold on their behalf, the Depositary may, after consultation with the Company, make that right of election available for exercise by Owners in any manner the Depositary considers to be lawful and practical. As a condition of making a distribution election right available to Owners, the Depositary may require satisfactory assurances from the Company that doing so does not require registration of any securities under the Securities Act of 1933.

If the Depositary determines that any distribution received or to be made by the Depositary (including Shares and rights to subscribe therefor) is subject to any tax or other governmental charge that the Depositary is obligated to withhold, the Depositary may sell, by public or private sale, all or a portion of the distributed property (including Shares and rights to subscribe therefor) in the amounts and manner the Depositary deems necessary and practicable to pay those taxes or charges, and the Depositary shall distribute the net proceeds of that sale, after deduction of those taxes or charges, to the Owners entitled thereto in proportion to the number of American Depositary Shares held by them respectively.

Each Owner and Holder agrees to indemnify the Company, the Depositary, the Custodian and their respective directors, employees, agents and affiliates for, and hold each of them harmless against, any claim by any governmental authority with respect to taxes, additions to tax, penalties or interest arising out of any refund of taxes, reduced withholding at source or other tax benefit received by it. Services for Owners and Holders that may permit them to obtain reduced rates of tax withholding at source or reclaim excess tax withheld, and the fees and costs associated with using services of that kind, are not provided under, and are outside the scope of, the Deposit Agreement.

 

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The Depositary shall, to the extent required by U.S. law, report to the Owners any taxes or governmental charges withheld from or paid out of a distribution on Deposited Securities by it, the Custodian or, to the extent such information is received from the Company, the Company.

 

13.

RIGHTS.

(a)    If rights are granted to the Depositary in respect of deposited Shares to purchase additional Shares or other securities, the Company and the Depositary shall endeavor to consult as to the actions, if any, the Depositary should take in connection with that grant of rights. The Depositary may, to the extent deemed by it to be lawful and practical (i) if requested in writing by the Company, grant to all or certain Owners rights to instruct the Depositary to purchase the securities to which the rights relate and deliver those securities or American Depositary Shares representing those securities to Owners, (ii) if requested in writing by the Company, deliver the rights to or to the order of certain Owners, or (iii) sell the rights to the extent practicable and distribute the net proceeds of that sale to Owners entitled to those proceeds. To the extent rights are not exercised, delivered or disposed of under (i), (ii) or (iii) above, the Depositary shall permit the rights to lapse unexercised.

(b)    If the Depositary will act under (a)(i) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon instruction from an applicable Owner in the form the Depositary specified and upon payment by that Owner to the Depositary of an amount equal to the purchase price of the securities to be received upon the exercise of the rights, the Depositary shall, on behalf of that Owner, exercise the rights and purchase the securities. The purchased securities shall be delivered to, or as instructed by, the Depositary. The Depositary shall (i) deposit the purchased Shares under the Deposit Agreement and deliver American Depositary Shares representing those Shares to that Owner or (ii) deliver or cause the purchased Shares or other securities to be delivered to or to the order of that Owner. The Depositary will not act under (a)(i) above unless the offer and sale of the securities to which the rights relate are registered under the Securities Act of 1933 or the Depositary has received an opinion of United States counsel that is satisfactory to it to the effect that those securities may be sold and delivered to the applicable Owners without registration under the Securities Act of 1933.

(c)    If the Depositary will act under (a)(ii) above, the Company and the Depositary will enter into a separate agreement setting forth the conditions and procedures applicable to the particular offering. Upon (i) the request of an applicable Owner to deliver the rights allocable to the American Depositary Shares of that Owner to an account specified by that Owner to which the rights can be delivered and (ii) receipt of such documents as the Company and the Depositary agreed to require to comply with applicable law, the Depositary will deliver those rights as requested by that Owner.

 

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(d)    If the Depositary will act under (a)(iii) above, the Depositary will use reasonable efforts to sell the rights in proportion to the number of American Depositary Shares held by the applicable Owners and pay the net proceeds to the Owners otherwise entitled to the rights that were sold, upon an averaged or other practical basis without regard to any distinctions among such Owners because of exchange restrictions or the date of delivery of any American Depositary Shares or otherwise.

(e)    Payment or deduction of the fees of the Depositary as provided in Section 5.9 of the Deposit Agreement and payment or deduction of the expenses of the Depositary and any applicable taxes or other governmental charges shall be conditions of any delivery of securities or payment of cash proceeds under Section 4.4 of that Agreement.

(f)    The Depositary shall not be responsible for any failure to determine that it may be lawful or feasible to make rights available to or exercise rights on behalf of Owners in general or any Owner in particular, or to sell rights.

 

14.

CONVERSION OF FOREIGN CURRENCY.

Whenever the Depositary or the Custodian receives foreign currency, by way of dividends or other distributions or the net proceeds from the sale of securities, property or rights, and if at the time of the receipt thereof the foreign currency so received can in the judgment of the Depositary be converted on a reasonable basis into Dollars and the resulting Dollars transferred to the United States, the Depositary shall convert or cause to be converted by sale or in any other manner that it may determine that foreign currency into Dollars, and those Dollars shall be distributed to the Owners entitled thereto. A cash distribution may be made upon an averaged or other practicable basis without regard to any distinctions among Owners based on exchange restrictions, the date of delivery of any American Depositary Shares or otherwise and shall be net of any expenses of conversion into Dollars incurred by the Depositary as provided in Section 5.9 of the Deposit Agreement.

If a conversion of foreign currency or the repatriation or distribution of Dollars can be effected only with the approval or license of any government or agency thereof, the Depositary may, but will not be required to, file an application for that approval or license.

If the Depositary determines that in its judgment any foreign currency received by the Depositary or the Custodian is not convertible on a reasonable basis into Dollars transferable to the United States, or if any approval or license of any government or agency thereof that is required for such conversion is not filed or sought by the Depositary or is not obtained within a reasonable period as determined by the Depositary, the Depositary may distribute the foreign currency received by the Depositary to, or in its discretion may hold such foreign currency uninvested and without liability for interest thereon for the respective accounts of, the Owners entitled to receive the same.

 

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If any conversion of foreign currency, in whole or in part, cannot be effected for distribution to some of the Owners entitled thereto, the Depositary may in its discretion make that conversion and distribution in Dollars to the extent practicable and permissible to the Owners entitled thereto and may distribute the balance of the foreign currency received by the Depositary to, or hold that balance uninvested and without liability for interest thereon for the account of, the Owners entitled thereto.

The Depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the Deposit Agreement and the rate that the Depositary or its affiliate receives when buying or selling foreign currency for its own account. The Depositary makes no representation that the exchange rate used or obtained in any currency conversion under the Deposit Agreement will be the most favorable rate that could be obtained at the time or that the method by which that rate will be determined will be the most favorable to Owners, subject to the Depositary’s obligations under Section 5.3 of that Agreement. The methodology used to determine exchange rates used in currency conversions is available upon request.

 

15.

RECORD DATES.

Whenever a cash dividend, cash distribution or any other distribution is made on Deposited Securities or rights to purchase Shares or other securities are issued with respect to Deposited Securities (which rights will be delivered to or exercised or sold on behalf of Owners in accordance with Section 4.4 of the Deposit Agreement) or the Depositary receives notice that a distribution or issuance of that kind will be made, or whenever the Depositary receives notice that a meeting of holders of Shares will be held in respect of which the Company has requested the Depositary to send a notice under Section 4.7 of the Deposit Agreement, or whenever the Depositary will assess a fee or charge against the Owners, or whenever the Depositary causes a change in the number of Shares that are represented by each American Depositary Share, or whenever the Depositary otherwise finds it necessary or convenient, the Depositary shall fix a record date, which shall be the same as, or as near as practicable to, any corresponding record date set by the Company with respect to Shares, (a) for the determination of the Owners (i) who shall be entitled to receive the benefit of that dividend or other distribution or those rights, (ii) who shall be entitled to give instructions for the exercise of voting rights at that meeting, (iii) who shall be responsible for that fee or charge or (iv) for any other purpose for which the record date was set, or (b) on or after which each American Depositary Share will represent the changed number of Shares. Subject to the provisions of Sections 4.1 through 4.5 of the

 

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Deposit Agreement and to the other terms and conditions of the Deposit Agreement, the Owners on a record date fixed by the Depositary shall be entitled to receive the amount distributable by the Depositary with respect to that dividend or other distribution or those rights or the net proceeds of sale thereof in proportion to the number of American Depositary Shares held by them respectively, to give voting instructions or to act in respect of the other matter for which that record date was fixed, or be responsible for that fee or charge, as the case may be.

 

16.

VOTING OF DEPOSITED SHARES.

(a)    Upon receipt of notice of any meeting of holders of Shares at which holders of Shares will be entitled to vote, if requested in writing by the Company, the Depositary shall, as soon as practicable thereafter, Disseminate to the Owners a notice, the form of which shall be in the sole discretion of the Depositary, that shall contain (i) the information contained in the notice of meeting received by the Depositary, (ii) a statement that the Owners as of the close of business on a specified record date will be entitled, subject to any applicable provision of Australian law and of the articles of association or similar documents of the Company, to instruct the Depositary as to the exercise of the voting rights pertaining to the amount of Shares represented by their respective American Depositary Shares, (iii) a statement as to the manner in which those instructions may be given and (iv) the last date on which the Depositary will accept instructions (the “Instruction Cutoff Date”).

(b)    Upon the written request of an Owner of American Depositary Shares, as of the date of the request or, if a record date was specified by the Depositary, as of that record date, received on or before any Instruction Cutoff Date established by the Depositary, the Depositary may, and if the Depositary sent a notice under the preceding paragraph shall, endeavor, in so far as practicable, to vote or cause to be voted the amount of deposited Shares represented by those American Depositary Shares in accordance with the instructions set forth in that request. The Depositary shall not vote or attempt to exercise the right to vote that attaches to the deposited Shares other than in accordance with instructions given by Owners and received by the Depositary.

(c)    There can be no assurance that Owners generally or any Owner in particular will receive the notice described in paragraph (a) above in time to enable Owners to give instructions to the Depositary prior to the Instruction Cutoff Date.

(d)    In order to give Owners a reasonable opportunity to instruct the Depositary as to the exercise of voting rights relating to Shares, if the Company will request the Depositary to Disseminate a notice under paragraph (a) above, the Company shall give the Depositary notice of the meeting, details concerning the matters to be voted upon and copies of materials to be made available to holders of Shares in connection with the meeting not less than [45] days prior to the meeting date.

 

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17.

TENDER AND EXCHANGE OFFERS; REDEMPTION, REPLACEMENT OR CANCELLATION OF DEPOSITED SECURITIES.

(a)    The Depositary shall not tender any Deposited Securities in response to any voluntary cash tender offer, exchange offer or similar offer made to holders of Deposited Securities (a “Voluntary Offer”), except when instructed in writing to do so by an Owner surrendering American Depositary Shares and subject to any conditions or procedures the Depositary may require.

(b)    If the Depositary receives a written notice that Deposited Securities have been redeemed for cash or otherwise purchased for cash in a transaction that is mandatory and binding on the Depositary as a holder of those Deposited Securities (a “Redemption”), the Depositary, at the expense of the Company, shall (i) if required, surrender Deposited Securities that have been redeemed to the issuer of those securities or its agent on the redemption date, (ii) Disseminate a notice to Owners (A) notifying them of that Redemption, (B) calling for surrender of a corresponding number of American Depositary Shares and (C) notifying them that the called American Depositary Shares have been converted into a right only to receive the money received by the Depositary upon that Redemption and those net proceeds shall be the Deposited Securities to which Owners of those converted American Depositary Shares shall be entitled upon surrenders of those American Depositary Shares in accordance with Section 2.5 or 6.2 of the Deposit Agreement and (iii) distribute the money received upon that Redemption to the Owners entitled to it upon surrender by them of called American Depositary Shares in accordance with Section 2.5 of that Agreement (and, for the avoidance of doubt, Owners shall not be entitled to receive that money under Section 4.1 of that Agreement). If the Redemption affects less than all the Deposited Securities, the Depositary shall call for surrender a corresponding portion of the outstanding American Depositary Shares and only those American Depositary Shares will automatically be converted into a right to receive the net proceeds of the Redemption. The Depositary shall allocate the American Depositary Shares converted under the preceding sentence among the Owners pro-rata to their respective holdings of American Depositary Shares immediately prior to the Redemption, except that the allocations may be adjusted so that no fraction of a converted American Depositary Share is allocated to any Owner. A Redemption of all or substantially all of the Deposited Securities shall be a Termination Option Event.

(c)    If the Depositary is notified of or there occurs any change in nominal value or any subdivision, combination or any other reclassification of the Deposited Securities or any recapitalization, reorganization, sale of assets substantially as an entirety, merger or consolidation affecting the issuer of the Deposited Securities or to which it is a party that is mandatory and binding on the Depositary as a holder of Deposited Securities and, as a result, securities or other property have been or will be delivered in exchange, conversion, replacement or in lieu of, Deposited Securities (a “Replacement”), the Depositary shall, if required, surrender the old Deposited Securities affected by that Replacement of Shares and hold, as new Deposited Securities under the Deposit Agreement, the new securities or

 

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other property delivered to it in that Replacement. However, the Depositary may elect to sell those new Deposited Securities if in the opinion of the Depositary it is not lawful or not practical for it to hold those new Deposited Securities under the Deposit Agreement because those new Deposited Securities may not be distributed to Owners without registration under the Securities Act of 1933 or for any other reason, at public or private sale, at such places and on such terms as it deems proper and proceed as if those new Deposited Securities had been Redeemed under paragraph (b) above. A Replacement shall be a Termination Option Event.

(d)    In the case of a Replacement where the new Deposited Securities will continue to be held under the Deposit Agreement, the Depositary may call for the surrender of outstanding Receipts to be exchanged for new Receipts specifically describing the new Deposited Securities and the number of those new Deposited Securities represented by each American Depositary Share. If the number of Shares represented by each American Depositary Share decreases as a result of a Replacement, the Depositary may call for surrender of the American Depositary Shares to be exchanged on a mandatory basis for a lesser number of American Depositary Shares and may sell American Depositary Shares to the extent necessary to avoid distributing fractions of American Depositary Shares in that exchange and distribute the net proceeds of that sale to the Owners entitled to them.

(e)    If there are no Deposited Securities with respect to American Depositary Shares, including if the Deposited Securities are cancelled, or the Deposited Securities with respect to American Depositary Shares become apparently worthless, the Depositary may call for surrender of those American Depositary Shares or may cancel those American Depositary Shares, upon notice to Owners, and that condition shall be a Termination Option Event.

 

18.

LIABILITY OF THE COMPANY AND DEPOSITARY.

Neither the Depositary nor the Company nor any of their respective directors, employees, agents or affiliates shall incur any liability to any Owner or Holder:

(i)    if by reason of (A) any provision of any present or future law or regulation or other act of the government of the United States, any State of the United States or any other state or jurisdiction, or of any governmental or regulatory authority or stock exchange; (B) (in the case of the Depositary only) any provision, present or future, of the articles of association or similar document of the Company, or by reason of any provision of any securities issued or distributed by the Company, or any offering or distribution thereof; or (C) any event or circumstance, whether natural or caused by a person or persons, that is beyond the ability of the Depositary or the Company, as the case may be, to prevent or counteract by reasonable care or effort (including, but not limited to earthquakes, floods, severe storms, fires, explosions, war, terrorism, civil unrest, labor disputes or criminal acts; interruptions or malfunctions of utility services, Internet or other communications lines or systems; unauthorized access to or attacks on computer systems or websites; or other failures or malfunctions of computer hardware or software or other systems or equipment),

 

A-16


the Depositary or the Company is, directly or indirectly, prevented from, forbidden to or delayed in, or could be subject to any civil or criminal penalty on account of doing or performing and therefore does not do or perform, any act or thing that, by the terms of the Deposit Agreement or the Deposited Securities, it is provided shall be done or performed;

(ii) for any exercise of, or failure to exercise, any discretion provided for in the Deposit Agreement (including any determination by the Depositary to take, or not take, any action that the Deposit Agreement provides the Depositary may take);

(iii) for the inability of any Owner or Holder to benefit from any distribution, offering, right or other benefit that is made available to holders of Deposited Securities but is not, under the terms of the Deposit Agreement, made available to Owners or Holders; or

(iv) for any special, consequential or punitive damages for any breach of the terms of the Deposit Agreement.

Where, by the terms of a distribution to which Section 4.1, 4.2 or 4.3 of the Deposit Agreement applies, or an offering to which Section 4.4 of that Agreement applies, or for any other reason, that distribution or offering may not be made available to Owners, and the Depositary may not dispose of that distribution or offering on behalf of Owners and make the net proceeds available to Owners, then the Depositary shall not make that distribution or offering available to Owners, and shall allow any rights, if applicable, to lapse.

Neither the Company nor the Depositary assumes any obligation or shall be subject to any liability under the Deposit Agreement to Owners or Holders, except that they agree to perform their obligations specifically set forth in the Deposit Agreement without negligence or bad faith. The Depositary shall not be a fiduciary or have any fiduciary duty to Owners or Holders. The Depositary shall not be subject to any liability with respect to the validity or worth of the Deposited Securities. Neither the Depositary nor the Company shall be under any obligation to appear in, prosecute or defend any action, suit, or other proceeding in respect of any Deposited Securities or in respect of the American Depositary Shares, on behalf of any Owner or Holder or other person. Neither the Depositary nor the Company shall be liable for any action or non-action by it in reliance upon the advice of or information from legal counsel, accountants, any person presenting Shares for deposit, any Owner or Holder, or any other person believed by it in good faith to be competent to give such advice or information. Each of the Depositary and the Company may rely, and shall be protected in relying upon, any written notice, request, direction or other document believed by it to be genuine and to have been signed or presented by the proper party or parties. The Depositary shall not be liable for any acts or omissions made by a successor depositary whether in connection with a previous act or omission of the Depositary or in connection with a matter arising wholly after the removal or resignation of the Depositary, provided that in connection with the issue out of which such potential liability arises, the Depositary performed its obligations without negligence or bad faith while it acted as Depositary. The Depositary shall not be liable for the acts or omissions of any securities

 

A-17


depository, clearing agency or settlement system in connection with or arising out of book-entry settlement of American Depositary Shares or Deposited Securities or otherwise. In the absence of bad faith on its part, the Depositary shall not be responsible for any failure to carry out any instructions to vote any of the Deposited Securities or for the manner in which any such vote is cast or the effect of any such vote. The Depositary shall have no duty to make any determination or provide any information as to the tax status of the Company or any liability for any tax consequences that may be incurred by Owners or Holders as a result of owning or holding American Depositary Shares. The Depositary shall not be liable for the inability or failure of an Owner or Holder to obtain the benefit of a foreign tax credit, reduced rate of withholding or refund of amounts withheld in respect of tax or any other tax benefit. No disclaimer of liability under the United States federal securities laws is intended by any provision of the Deposit Agreement.

 

19.

RESIGNATION AND REMOVAL OF THE DEPOSITARY; APPOINTMENT OF SUCCESSOR CUSTODIAN.

The Depositary may at any time resign as Depositary under the Deposit Agreement by written notice of its election so to do delivered to the Company, to become effective upon the appointment of a successor depositary and its acceptance of such appointment as provided in the Deposit Agreement. The Depositary may at any time be removed by the Company by 90 days’ prior written notice of that removal, to become effective upon the later of (i) the 90th day after delivery of the notice to the Depositary and (ii) the appointment of a successor depositary and its acceptance of its appointment as provided in the Deposit Agreement. The Depositary in its discretion may at any time appoint a substitute or additional custodian or custodians.

 

20.

AMENDMENT.

The form of the Receipts and any provisions of the Deposit Agreement may at any time and from time to time be amended by agreement between the Company and the Depositary without the consent of Owners or Holders in any respect which they may deem necessary or desirable. Any amendment that would impose or increase any fees or charges (other than taxes and other governmental charges, registration fees, cable, telex or facsimile transmission costs, delivery costs or other such expenses), or that would otherwise prejudice any substantial existing right of Owners, shall, however, not become effective as to outstanding American Depositary Shares until the expiration of 30 days after notice of that amendment has been Disseminated to the Owners of outstanding American Depositary Shares. Every Owner and Holder, at the time any amendment so becomes effective, shall be deemed, by continuing to hold American Depositary Shares or any interest therein, to consent and agree to that amendment and to be bound by the Deposit Agreement as amended thereby. Upon the effectiveness of an amendment to the form of Receipt, including a change in the number of Shares represented by each American Depositary Share, the Depositary may call for surrender of Receipts to be replaced with new Receipts in the amended form or call for surrender of American Depositary Shares to effect that

 

A-18


change of ratio. In no event shall any amendment impair the right of the Owner to surrender American Depositary Shares and receive delivery of the Deposited Securities represented thereby, except in order to comply with mandatory provisions of applicable law.

 

21.

TERMINATION OF DEPOSIT AGREEMENT.

(a)    The Company may initiate termination of the Deposit Agreement by notice to the Depositary. The Depositary may initiate termination of the Deposit Agreement if (i) at any time 60 days shall have expired after the Depositary delivered to the Company a written resignation notice and a successor depositary has not been appointed and accepted its appointment as provided in Section 5.4 of that Agreement, (ii) an Insolvency Event or Delisting Event occurs with respect to the Company or (iii) a Termination Option Event has occurred or will occur. If termination of the Deposit Agreement is initiated, the Depositary shall Disseminate a notice of termination to the Owners of all American Depositary Shares then outstanding setting a date for termination (the “Termination Date”), which shall be at least 90 days after the date of that notice, and the Deposit Agreement shall terminate on that Termination Date.

(b)    After the Termination Date, the Company shall be discharged from all obligations under the Deposit Agreement except for its obligations to the Depositary under Sections 5.8 and 5.9 of that Agreement.

(c)    At any time after the Termination Date, the Depositary may sell the Deposited Securities then held under the Deposit Agreement and may thereafter hold uninvested the net proceeds of any such sale, together with any other cash then held by it hereunder, unsegregated and without liability for interest, for the pro rata benefit of the Owners of American Depositary Shares that remain outstanding, and those Owners will be general creditors of the Depositary with respect to those net proceeds and that other cash. After making that sale, the Depositary shall be discharged from all obligations under the Deposit Agreement, except (i) to account for the net proceeds and other cash (after deducting, in each case, the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of such American Depositary Shares in accordance with the terms and conditions of the Deposit Agreement and any applicable taxes or governmental charges) and (ii) for its obligations under Section 5.8 of that Agreement and (iii) to act as provided in paragraph (d) below.

(d)    After the Termination Date, the Depositary shall continue to receive dividends and other distributions pertaining to Deposited Securities (that have not been sold), may sell rights and other property as provided in the Deposit Agreement and shall deliver Deposited Securities (or sale proceeds) upon surrender of American Depositary Shares (after payment or upon deduction, in each case, of the fee of the Depositary for the surrender of American Depositary Shares, any expenses for the account of the Owner of those American Depositary Shares in accordance with the terms and conditions of the Deposit Agreement and any applicable taxes or governmental charges). After the Termination Date, the Depositary shall not accept deposits of Shares or deliver American

 

A-19


Depositary Shares. After the Termination Date, (i) the Depositary may refuse to accept surrenders of American Depositary Shares for the purpose of withdrawal of Deposited Securities (that have not been sold) or reverse previously accepted surrenders of that kind that have not settled if in its judgment the requested withdrawal would interfere with its efforts to sell the Deposited Securities, (ii) the Depositary will not be required to deliver cash proceeds of the sale of Deposited Securities until all Deposited Securities have been sold and (iii) the Depositary may discontinue the registration of transfers of American Depositary Shares and suspend the distribution of dividends and other distributions on Deposited Securities to the Owners and need not give any further notices or perform any further acts under the Deposit Agreement except as provided in Section 6.2 of that Agreement.

 

22.

DTC DIRECT REGISTRATION SYSTEM AND PROFILE MODIFICATION SYSTEM.

(a)    Notwithstanding the provisions of Section 2.4 of the Deposit Agreement, the parties acknowledge that DTC’s Direct Registration System (“DRS”) and Profile Modification System (“Profile”) apply to the American Depositary Shares upon acceptance thereof to DRS by DTC. DRS is the system administered by DTC that facilitates interchange between registered holding of uncertificated securities and holding of security entitlements in those securities through DTC and a DTC participant. Profile is a required feature of DRS that allows a DTC participant, claiming to act on behalf of an Owner of American Depositary Shares, to direct the Depositary to register a transfer of those American Depositary Shares to DTC or its nominee and to deliver those American Depositary Shares to the DTC account of that DTC participant without receipt by the Depositary of prior authorization from the Owner to register that transfer.

(b)    In connection with DRS/Profile, the parties acknowledge that the Depositary will not determine whether the DTC participant that is claiming to be acting on behalf of an Owner in requesting registration of transfer and delivery as described in paragraph (a) above has the actual authority to act on behalf of that Owner (notwithstanding any requirements under the Uniform Commercial Code). For the avoidance of doubt, the provisions of Sections 5.3 and 5.8 of the Deposit Agreement apply to the matters arising from the use of the DRS/Profile. The parties agree that the Depositary’s reliance on and compliance with instructions received by the Depositary through the DRS/Profile system and otherwise in accordance with the Deposit Agreement shall not constitute negligence or bad faith on the part of the Depositary.

 

23.

APPOINTMENT OF AGENT FOR SERVICE OF PROCESS; SUBMISSION TO JURISDICTION; JURY TRIAL WAIVER; WAIVER OF IMMUNITIES.

The Company has (i) appointed                     , located in the State of New York, as the Company’s authorized agent upon which process may be served in any suit or proceeding arising out of or relating to the Shares or Deposited Securities, the American Depositary Shares, the Receipts or this Agreement, (ii) consented

 

A-20


and submitted to the jurisdiction of any state or federal court in the State of New York in which any such suit or proceeding may be instituted, and (iii) agreed that service of process upon said authorized agent shall be deemed in every respect effective service of process upon the Company in any such suit or proceeding.

EACH PARTY TO THE DEPOSIT AGREEMENT (INCLUDING, FOR AVOIDANCE OF DOUBT, EACH OWNER AND HOLDER) THEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING AGAINST THE COMPANY AND/OR THE DEPOSITARY DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THE SHARES OR OTHER DEPOSITED SECURITIES, THE AMERICAN DEPOSITARY SHARES OR THE RECEIPTS, THE DEPOSIT AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREIN OR THEREIN, OR THE BREACH HEREOF OR THEREOF, INCLUDING, WITHOUT LIMITATION, ANY QUESTION REGARDING EXISTENCE, VALIDITY OR TERMINATION (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY).

To the extent that the Company or any of its properties, assets or revenues may have or hereafter become entitled to, or have attributed to it, any right of immunity, on the grounds of sovereignty or otherwise, from any legal action, suit or proceeding, from the giving of any relief in any respect thereof, from setoff or counterclaim, from the jurisdiction of any court, from service of process, from attachment upon or prior to judgment, from attachment in aid of execution or judgment, or from execution of judgment, or other legal process or proceeding for the giving of any relief or for the enforcement of any judgment, in any jurisdiction in which proceedings may at any time be commenced, with respect to its obligations, liabilities or any other matter under or arising out of or in connection with the Shares or Deposited Securities, the American Depositary Shares, the Receipts or the Deposit Agreement, the Company, to the fullest extent permitted by law, hereby irrevocably and unconditionally waives, and agrees not to plead or claim, any such immunity and consents to such relief and enforcement.

 

A-21

EX-4.1

Exhibit 4.1

Employee Incentive Option Plan

Avita Medical Limited

ACN 058 466 523


Table of Contents

 

1.

   The plan      1  

2.

   Eligibility      1  

3.

   Participation      1  

3.1      

   Invitation to participate      1  

3.2

   Application form      1  

3.3

   Nominee      2  

3.4

   Participant bound by application form, rules and constitution      2  

4.

   Grant of options      2  

4.1

   Grant of options      2  

4.2

   Nominal payment for options      2  

4.3

   Options non-transferable      2  

4.4

   Quotation of Options      2  

4.5

   Option certificate      2  

5.

   Exercise of Options      3  

5.1

   Manner of exercise of Options      3  

5.2

   Vesting      3  

5.3

   Vesting conditions      3  

5.4

   Lapse of an Option      4  

5.5

   Issue or transfer of shares on exercise      4  

5.6

   Shares rank equally      4  

5.7

   Financial assistance      5  

5.8

   Withholding      5  

5.9

   Plan Limit      5  

5.10

   Sale Restrictions      5  

6.

   Changes in circumstances      6  

6.1

   Reconstruction      6  

6.2

   Participation in new issues      6  

7.

   Amendment      6  

8.

   Powers of the Board      6  

8.1

   Powers of the Board      6  

8.2

   Indemnification      7  

8.3

   Termination or suspension of Plan      7  

8.4

   Resolution to terminate, suspend, supplement or amend      7  

9.

   Powers of the administrator      7  

9.1

   Appointment of administrator      7  

9.2

   Role of administrator      7  

10.

   Contracts of employment and other employment rights      7  

10.1

   Discretion of board      7  

10.2

   No right to grant of options      7  

10.3

   Calculation of employee benefits      7  

10.4

   No right to future employment etc.      8  

10.5

   Acknowledgment by Participant      8  

 

i


10.6

   Establishment of a Trust      8  

11.

   Connection with other plans      8  

12.

   Notices      8  

13.

   General      8  

14.

   Plan costs      8  

14.1

   Plan Costs      8  

14.2

   Reimbursement      8  

15.

   Overseas eligible employees      9  

16.

   Governing law      9  

17.

   Definitions and interpretation      9  

17.1

   Definitions      9  

17.2

   Interpretation      11  

 

ii


Avita Medical Limited—Employee Incentive Option Plan

 

1.

The plan

The purpose of the Plan is to provide Eligible Employees with an incentive to remain with the Group and to improve the longer-term performance of the Company and its return to shareholders. It is intended that the Plan will enable the Group to retain and attract skilled and experienced employees and provide them with the motivation to make the Group more successful.

 

2.

Eligibility

The Board may determine at any time that any Eligible Employee is not entitled to participate in the Plan if the Eligible Employee’s participation would be unlawful.

 

3.

Participation

 

3.1

Invitation to participate

Subject to these rules, the Board at its sole discretion may invite any Eligible Employee selected by it to complete an Application Form relating to a specified number of Options allocated to that Eligible Employee by the Board upon the terms set out in this Plan and upon such additional terms and conditions as the Board determines.

For the purpose of clarity, these rules are also to apply to all Options granted by the Company to employees prior to the date of adoption of these rules. An Option may be made subject to vesting conditions as determined by the Board in its discretion and as specified in the offer for the Option.

 

3.2

Application form

The Board must give to each Eligible Employee selected under rule 3.1 above, an Application Form together with an offer letter which sets out the following information relating to the Options proposed to be allocated to the Eligible Employee:

 

  (a)

the date of grant or intended date of grant;

 

  (b)

the total number of Options to be granted;

 

  (c)

the Exercise Period;

 

  (d)

the Exercise Price or the method of determining the Exercise Price;

 

  (e)

the Vesting Conditions attaching to the Options (if any);

 

  (f)

the Disposal Restrictions attaching to any Shares issued on exercise (if any);

 

  (g)

the Forfeiture Conditions attaching to the Options (if any);

 

  (h)

any other terms and conditions relating to the grant which, in the opinion of the Board, are fair and reasonable but not inconsistent with these rules (Special Conditions);

 

  (i)

in respect of the initial grant made to an Eligible Employee, a summary, or a copy of these rules; and

 

1


  (j)

any other information or documents required to be notified to the Eligible Employee by the Corporations Act or the Listing Rules.

As a condition of being offered the Options the Board may also require the Eligible Employee to enter a Share Option Agreement, subject to conditions as required by the Board.

 

3.3

Nominee

Eligible Employees may nominate for their Options to be granted to a nominee (provided that the disclosure relief in section 708(12) of the Corporations Act would extend to that nominee). However, the Board reserves the absolute discretion to refuse to issue the Options to the proposed nominee.

 

3.4

Participant bound by application form, rules and constitution

By completing and returning the Application Form, a Participant agrees (and if an election has been made by an Eligible Employee under rule 3.3 above, the Eligible Employee’s nominee agrees) to be bound by the terms of the Application Form, these rules, the Share Option Agreement (if any) and the Constitution.

 

4.

Grant of options

 

4.1

Grant of options

The Board may only grant Options to a Participant following receipt of a duly signed and completed Application Form and Share Option Agreement (if any) from the Participant.

 

4.2

Nominal payment for options

Unless the Options are quoted on the ASX, Options issued under the Option Plan will be issued for no more than nominal cash consideration.

 

4.3

Options non-transferable

An Option granted under the Plan is not capable of being transferred or encumbered by a Participant, unless the Board determines otherwise and at all times subject to the requirements of the Corporations Act and the ASX Listing Rules.

 

4.4

Quotation of Options

The Company has no obligation to apply for quotation of the Options on the ASX.

 

4.5

Option certificate

The Company must issue a Certificate to a Participant in respect of the Options granted to that Participant. The Company must comply with the provisions of the Constitution, the Share Option Agreement (if any), the Listing Rules and the Corporations Act relating to the issue of the Certificate.

 

2


5.

Exercise of Options

 

5.1

Manner of exercise of Options

The exercise of any Option granted under the Plan may only be effected in such form and manner as the Board may prescribe, which may include the automatic exercise of Options.

 

5.2

Vesting

The Board may in its absolute discretion (except in respect of a Control Event occurring where the Board has determined that Vesting Conditions are deemed to be automatically waived) by written notice to a Participant (or, where a Participant is a person nominated by an Eligible Employee, the executive or director who nominated the Participant) (collectively Relevant Person), resolve to waive any of the Vesting Conditions applying to Options due to:

 

  (a)

Special Circumstances arising in relation to a Relevant Person in respect of those Performance Rights, being:

 

  (i)

a Relevant Person ceasing to be an Eligible Employee due to:

 

  (A)

death or total or permanent disability of a Relevant Person; or

 

  (B)

retirement or redundancy of a Relevant Person;

 

  (ii)

a Relevant Person suffering severe financial hardship;

 

  (iii)

any other circumstance (if any) stated to constitute “Special Conditions” in the terms of the relevant Offer made to and accepted by the Participant; or

 

  (iv)

any other circumstances determined by the Board at any time (whether before or after the Offer) and notified to the relevant Participant which circumstances may relate to the Participant, a class of Participant, including the Participant or particular circumstances or class of circumstances applying to the Participant; or

 

  (b)

a Control Event occurring; or

 

  (c)

the Company passing a resolution for voluntary winding up, or an order is made for the compulsory winding up of the Company.

 

5.3

Vesting conditions

Subject to rules 5.2 and 5.4, an Option granted under the Plan may only be exercised:

 

  (a)

if all the Vesting Conditions have been met and /or waived by the Board;

 

  (b)

if the Exercise Price has been paid to the Company or as the Company may direct; and

 

  (c)

within the Exercise Period relating to the Option.

An Option granted under the Plan may not be exercised once it has lapsed.

 

3


5.4

Lapse of an Option

An Option will lapse upon the earlier to occur of:

 

  (a)

an unauthorised dealing in the Option;

 

  (b)

a Vesting Condition in relation to the Option is not satisfied by its due date, or becomes incapable of satisfaction, unless the Board exercises its discretion to waive the Vesting Conditions and vest the Option in the circumstances set out in rule 5.2 or the Board resolves, in its absolute discretion, to allow the unvested Options to remain unvested after the Relevant Person ceases to be an Eligible Employee;

 

  (c)

in respect of unvested Option only, a Relevant Person ceases to be an Eligible Employee, unless the Board exercises its discretion to vest the Option in the circumstances set out in rule 5.2 or the Board resolves, in its absolute discretion, to allow the unvested Options to remain unvested after the Relevant Person ceases to be an Eligible Employee;

 

  (d)

in respect of vested Options only, a Relevant Person ceases to be an Eligible Employee and the Option granted in respect of that person is not exercised within one (1) month (or such later date as the Board determines) of the date that person ceases to be an Eligible Employee;

 

  (e)

the Board deems that an Option lapses due to fraud, dishonesty or other improper behaviour of the Relevant Person;

 

  (f)

the Company undergoes a Control Event or a winding up resolution or order is made and the Board does not exercise its discretion to vest the Option;

 

  (g)

on liquidation of the Company;

 

  (h)

on the occurrence of a Forfeiture Condition relating to that Option, unless the Board determines otherwise; or

 

  (i)

the expiry date of the Option.

 

5.5

Issue or transfer of shares on exercise

Following exercise of an Option by a Participant, the Company must, within such time as the Board determines, allot and issue or procure the transfer to the Participant of the number of Shares in respect of which the Option has been exercised, credited as fully paid.

 

5.6

Shares rank equally

Subject to the satisfaction of any applicable Disposal Restrictions, Shares allotted and issued under the Plan must rank equally in all respects with all other Shares from the date of allotment and issue, including:

 

  (a)

voting rights; and

 

  (b)

entitlements to participate in:

 

  (i)

distributions and dividends; and

 

4


  (ii)

future rights issues and bonus issues,

where the record date for determining entitlements falls on or after the date of allotment and issue.

 

5.7

Financial assistance

The Company may, but is not obliged to, financially assist a person to pay any Exercise Price for an Option, subject to compliance with the provisions of the Corporations Act and the Listing Rules, including in relation to financial assistance.

 

5.8

Withholding

 

  (a)

If the Company or any member of the Group has an obligation in relation to a tax liability associated with the grant or vesting of any Option (Tax Liability), then the Company may sell a sufficient number of Shares, post vesting or exercise of the Option, to cover the Tax Liability.

 

  (b)

A Participant may enter into alternative arrangements, if acceptable to the Board, to settle any Tax Liability.

 

5.9

Plan Limit

The Company must, at the time of inviting an Eligible Employee to participate in the Plan, have reasonable grounds to believe that the Shares that have been or may be issued as a result of the exercise of Options offered in reliance on the Class Order will not exceed 5% of the total number of Shares on issue, including:

 

  (a)

Shares that may be issued under the invitation or offer to participate; and

 

  (b)

Shares issued or that may be issued as a result of invitations or offers to participants made at any time during the previous 3 year period under:

 

  (i)

an employee incentive scheme or like scheme of the Company where offers were made in reliance on the Class Order or an individual instrument made by ASIC in terms similar to that class order; or

 

  (ii)

an employee incentive scheme or employee share scheme of the Company where the offers were covered under ASIC Class Order CO 03/184 or an individual instrument made by ASIC in terms similar to that class order.

 

5.10

Sale Restrictions

The Board may, in its discretion, determine at any time up until exercise of Options, that a restriction period will apply to some or all of the Shares issued to an Eligible Participant (or their eligible nominee) on exercise of those Options up to a maximum of seven (7) years from the grant date of the Options. In addition, the Board may, in its sole discretion, having regard to the circumstances at the time, waive any such restriction period determined.

 

5


6.

Changes in circumstances

 

6.1

Reconstruction

In the event of any reconstruction (including consolidation, subdivision, reduction, capital return, buy back, cancellation of the share capital of the Company or the establishment or inclusion of a holding company of the Company as part of the Group), the number of Options to which each Participant is entitled and/or the Exercise Price of those Options must be reconstructed in accordance with the Listing Rules. Where a new holding company forms part of the reconstructed Group, unless the Board determines otherwise, upon the exercise of the Options the holder of the Options will be issued securities in the new holding company rather than the Company. Options must be reconstructed in a manner which will not result in any additional benefits being conferred on Participants which are not conferred on other shareholders of the Company. All rights of a holder of an Option are to be changed in a manner consistent with the Corporations Act and the ASX Listing Rules at the time of the reorganisation. Unless specified in the offer of the Options and subject to compliance with the ASX Listing Rules, an Option does not confer the right to a change in exercise price or in the number of underlying Shares over which the Option can be exercised.

 

6.2

Participation in new issues

Subject to the Listing Rules, a Participant is only entitled to participate (in respect of Options granted under the Plan) in a new issue of Shares to existing shareholders generally if the Participant has validly exercised his or her Options within the relevant Exercise Period and become a Shareholder prior to the relevant record date, and is then only entitled to participate in relation to Shares of which the Participant is the registered holder. There are no participating rights or entitlements inherent in the Options and holders will not be entitled to participate in new issues of capital offered to Shareholders during the currency of the Options unless and to the extent the Options are exercised before the relevant record date for the applicable new issue.

 

7.

Amendment

Subject to the Listing Rules, these rules may be amended or supplemented by resolution of the Board. Unless the resolution of the Board expressly states otherwise, any amendment or supplement to these rules will not apply to any Options granted under these rules prior to the amendment and which have not yet been exercised.

 

8.

Powers of the Board

 

8.1

Powers of the Board

The Plan will be managed by the Board, which will have power to:

 

  (a)

determine appropriate procedures for the administration of the Plan consistent with these rules;

 

  (b)

resolve conclusively all questions of fact or interpretation arising in connection with the Plan;

 

  (c)

determine matters falling for determination under these rules in its discretion having regard to the interests of and for the benefit of the Company;

 

6


  (d)

exercise the discretions conferred on it by these rules or which may otherwise be required in relation to the Plan; and

 

  (e)

delegate to any one or more persons (for such period and on such conditions as it may determine) the exercise of any of its powers or discretions arising under the Plan.

 

8.2

Indemnification

The Company must indemnify, and keep indemnified, to the full extent permitted by law, each person who is or has been a director or alternate director of the Company against all proceedings, actions, claims, demands, losses, liabilities, damages, costs and expenses which may be made, brought against, suffered or incurred by the person arising directly or indirectly out of or in connection with the administration of the Plan.

 

8.3

Termination or suspension of Plan

The Board may terminate or suspend the operation of the Plan at any time.

 

8.4

Resolution to terminate, suspend, supplement or amend

In passing a resolution to terminate or suspend the operation of the Plan or to supplement or amend these rules, the Board must consider and endeavour to ensure that there is fair and equitable treatment of all Participants.

 

9.

Powers of the administrator

 

9.1

Appointment of administrator

The Board may appoint an Administrator and may determine the terms and conditions of the Administrator’s appointment. The Board may remove the Administrator.

 

9.2

Role of administrator

The Administrator must administer the Plan in accordance with these rules and any procedures determined by the Board and agreed to as between the Board and the Administrator.

 

10.

Contracts of employment and other employment rights

 

10.1

Discretion of board

It is a condition of these rules that the Plan may be terminated at any time at the discretion of the Board and that no compensation under any employment contract will arise as a result.

 

10.2

No right to grant of options

Participation in the Plan as an Eligible Employee does not confer on any Eligible Employee any right to a grant of Options.

 

10.3

Calculation of employee benefits

The value of the Options do not increase a Participant’s income for the purpose of calculating any employee benefits.

 

7


10.4

No right to future employment etc.

Participation in the Plan does not confer on any Participant any right to future employment and does not affect any rights which the Company may have to terminate the employment of any Participant.

 

10.5

Acknowledgment by Participant

It is acknowledged and accepted by each Participant that the terms of the Plan do not form part of the terms and conditions of the Participant’s employment contract, nor do the terms of the Plan constitute a contract or arrangement (including any related condition or collateral arrangement) in relation to the Participant’s employment contract.

 

10.6

Establishment of a Trust

The Board may, at any time, establish a trust for the sole purpose of acquiring and holding Shares in respect of which a Participant may exercise, or has exercised, vested Options, including for the purpose of enforcing the disposal restrictions and appoint a trustee to act as trustee of the trust. The trustee will hold the Shares as trustee for and on behalf of a Participant as beneficial owner upon the terms of the trust. The Board may at any time amend all or any of the provisions of the Plan to effect the establishment of such a trust and the appointment of such a trustee.

 

11.

Connection with other plans

Unless the Board otherwise determines, participation in the Plan does not affect, and is not affected by, participation in any other incentive or other plan operated by the Company unless the terms of that other plan provide otherwise.

 

12.

Notices

Any notice or direction given under these rules is validly given if it is handed to the person concerned or sent by ordinary prepaid post to the person’s last known address or given in any reasonable manner which the Board from time to time determines.

 

13.

General

Notwithstanding any rule, Shares may not be allotted and issued, acquired, transferred or otherwise dealt with under the Plan if to do so would contravene the Corporations Act, the Listing Rules, or any other applicable laws.

 

14.

Plan costs

 

14.1

Plan Costs

Unless otherwise determined by the Board, the Company must pay all costs, charges and expenses relating to the establishment and operation of the Plan, including all costs incurred in or associated with an allotment, issue or acquisition of Shares for the purposes of enabling Participants to exercise Options granted to them under the Plan.

 

14.2

Reimbursement

The Company and any Associated Body Corporate of the Company may provide money to the trustee of any trust or any other person to enable them to acquire Shares to be held for the purposes of the Plan, or enter into any guarantee or indemnity for those

 

8


purposes, to the extent permitted by the Corporations Act. In addition, the Company may require any Associated Body Corporate to enter into any other agreement or arrangement as it considers necessary to oblige that Associated Body Corporate to reimburse the Company for any amounts paid by the Company in connection with this Plan, directly or indirectly, in relation to any employee or director of that Associated Body Corporate.

 

15.

Overseas eligible employees

The Company at the Board’s discretion may:

 

  (a)

grant options to Eligible Employees and Participants who are resident outside of Australia; and

 

  (b)

make regulations for the operation of the Plan which are not inconsistent with these rules to apply to Eligible Employees and Participants who are resident outside of Australia.

 

16.

Governing law

The laws of Victoria govern these rules.

 

17.

Definitions and interpretation

 

17.1

Definitions

In this document, unless the context requires otherwise:

Accounting Standards means the Australian Accounting Standards from time to time and if and to the extent that any matter is not covered by the Australian Accounting Standards means generally accepted accounting principles applied from time to time in Australia for a business similar to the Business.

Administrator means the person (if any) selected by the Board to carry out the day to day administration of the Plan as contemplated by rule 9.1.

Application Form means the form that the Board determines is to be used by an Eligible Employee to apply for Options under the Plan.

Associated Body Corporate of the Company means each:

 

  (a)

related body corporate of the Company, within the meaning of section 50 of the Corporations Act;

 

  (b)

body corporate that has voting power in the Company of not less than 20%; or

 

  (c)

body corporate in which the Company has voting power of not less than 20%,

where “voting power” has the meaning in section 610 of the Corporations Act.

ASIC means Australia Securities and Investments Commission.

ASX means ASX Limited (ACN 008 624 691) or the Australian Securities Exchange as the context requires.

 

9


Board means the board of directors of the Company or a committee appointed by the board of directors of the Company.

Certificate means, in relation to a Participant, the certificate or statement (in a form approved by the Board) issued to the Participant which discloses the number of Options entered in the register of Option holders in the name of the Participant.

Class Order means ASIC Class Order CO 14/1000.

Company means Avita Medical Limited ACN 058 466 523.

Constitution means the constitution of the Company.

Control of an entity means having the right:

 

  (a)

to vote more than 50% of the votes that can be cast on the election or removal of the entity’s directors;

 

  (b)

to appoint or remove directors who possess more than 50% of the votes exercisable by all directors of the entity; or

 

  (c)

more than 50% of the profits or distributions of the entity or of its net liquidation proceeds.

For this definition, if the entity does not have a board of directors, ‘director’ means a member of the entity’s governing body with a role similar to a board of directors.

Control Event means any of the following:

 

  (a)

any event that occurs which causes a change in Control of the Company; or

 

  (b)

any other event which the Board reasonably considers should be regarded as a Control Event; and

Corporations Act means Corporations Act 2001 (Cth).

Disposal Restrictions means, in relation to an Option, the restrictions (if any) determined by the Board that are required to be satisfied before a Share acquired as a result of the exercise of the Option by the Participant can be sold, transferred or otherwise dealt with by a Participant.

Eligible Employee means any:

 

  (a)

person who is employed (part time of full time) or engaged by the Group;

 

  (b)

director (whether executive or non-executive) or an executive or any member of the Group who is a senior manager for the purposes of section 708(12) of the Corporations Act;

 

  (c)

a casual employee or contractor of any member of the Group to the extent permitted by ASIC Class Order 14/1000 (as amended or replaced);

 

  (d)

any other person determined by the Board to be an Eligible Employee for the purposes of the Plan.

who is declared by the Board to be eligible to receive grants of Options under the Plan.

 

10


Exercise Period means, in relation to an Option, the period in which the Option may be exercised specified by the Board under rule 3.2, subject to any variation under rules 5.4 and 1.

Exercise Price means the amount that is specified by the Board under rule 3.2, subject to any adjustment under rule 1.1.

Forfeiture Conditions means, in relation to an Option, the conditions (if any) determined by the Board that will result in the Option lapsing if satisfied.

Group means the Company and each Associated Body Corporate of the Company and, for clarity, includes any interposed or subsequently established holding company of the Company.

Liquidation means the passing of a resolution for voluntary winding up, or the making of an order for the compulsory winding up of the Company.

Listing Rules means the listing rules (as defined in the Corporations Act) made or adopted by the ASX.

Option means a right to subscribe for or acquire a Share, subject to any adjustment under rule 1.1.

Participant means an Eligible Employee who has been invited to participate in the Plan and any other person who is nominated by that Eligible Employee under rule 3.3 and who is determined by the Board to be a Participant for the purposes of the Plan.

Plan means the Avita Medical Limited Employee Share Option Plan established and operated in accordance with these rules.

Relevant Person has the meaning as provided in rule 5.2.

Share means a fully paid ordinary share in the capital of the Company.

Share Option Agreement means an agreement to be entered by the Eligible Employee and the Company pursuant to which the Board may specify provisions of this Plan which, under the Board’s discretion under this Plan, the Board has determined will or will not apply to the Particular Eligible Employee.

Special Conditions has the meaning as provided in rule 3.2(h).

Vesting Conditions means, in relation to an Option, the period of time, performance hurdles and other conditions (if any) determined by the Board that are required to be satisfied before the Option can be exercised.

Vested Option means an Option in respect of which all Vesting Conditions have been met or which are otherwise exercisable (including as contemplated by rule 5.4).

 

17.2

Interpretation

In these rules, unless the context otherwise requires:

 

  (a)

a reference to any thing (including an amount or a provision of this document) is a reference to the whole and each part of it;

 

  (b)

the singular includes the plural, and vice versa;

 

11


  (c)

the word ‘person’ includes an individual, a body corporate, a firm, an unincorporated body, a society, an association and an authority;

 

  (d)

a reference to a particular person includes their legal personal representatives, administrators, successors, substitutes and permitted assigns;

 

  (e)

a reference to ‘costs’ includes charges, expenses and legal costs;

 

  (f)

a reference to a “rule” or “these rules” is to the rule or these rules (as the case may be) as amended or replaced;

 

  (g)

a reference to the Constitution includes a reference to any provision having substantially the same effect which is substituted for or replaces the Constitution;

 

  (h)

where a Participant is a director of any member of the Group, but is not also an employee of any member of the Group, a reference to the employment with any member of the Group of that Participant is a reference to that Participant holding office as a director of any member of the Group;

 

  (i)

where a Participant is a person nominated by an Eligible Employee, a reference to the employment with any member of the Group of that Participant is a reference to the employment with any member of the Group of that Eligible Employee;

 

  (j)

a Participant does not cease to be employed by any member of the Group where the Participant ceases to be employed by one member of the Group but commences employment with another member of the Group provided that the new employment commences within 60 days from the date of termination or such other period as the Board may determine by notice in writing;

 

  (k)

a reference to ‘law’ means statute law, common law and equitable principles;

 

  (l)

a reference to a particular law includes that law and any subordinate legislation (such as regulations) under it, in each case as amended, replaced, re-enacted or consolidated;

 

  (m)

a reference to an accounting term is to that term as it is used in the Accounting Standards;

 

  (n)

a reference to ‘dollars’, ‘$‘ or ‘A$’ is to the lawful currency of Australia;

 

  (o)

a time means that time in Melbourne, Australia;

 

  (p)

a reference to a day or a month means a calendar day or calendar month;

 

  (q)

if a period of time starts from a given day (or event), it is to be calculated exclusive of that day (or the day the event occurs);

 

  (r)

the masculine includes the feminine, and vice versa;

 

  (s)

the meaning of any general language is not restricted by any accompanying example and the words ‘includes’, ‘including’ ‘such as’ or ‘for example’ (or similar phrases) are not words of limitation; and

 

  (t)

headings in this document are for convenience only and do not affect its meaning.

If (but for this rule) a provision of this document would be illegal, void or unenforceable or contravene the law, this document is to be interpreted as if the provision was omitted.

 

12

EX-4.2

Exhibit 4.2

Employee Share Plan

AVITA MEDICAL LIMITED

ACN 058 466 523


Table of Contents

 

1.   The Plan      1  
1.1   Purpose      1  
1.2   Commencement      1  
1.3   Termination or suspension of Plan      1  
1.4   Connection with other plans      1  
2.   Eligibility      1  
2.1   Participation by Eligible Employees      1  
2.2           Overseas Eligible Employees      1  
3.   Participation      2  
3.1   Invitation to participate      2  
3.2   Application Form      2  
3.3   Participant bound by Application Form, Plan and Constitution      2  
4.   Allocation of Shares      2  
4.1   Allocation of Shares      2  
4.2   Method of consideration      2  
4.3   Holding Statements      2  
5.   Issue of Shares      3  
6.   Nature of Shares      3  
6.1   General      3  
6.2   Ranking      3  
6.3   Voting      3  
6.4   Entitlement to dividends      3  
6.5   Transfer restrictions on Shares      3  
7.   Buyback or Sale of Shares      3  
7.1   Unfulfilled Vesting Condition      3  
7.2   Ceasing Employment before Restriction Conditions satisfied      4  
8.   Contracts of employment and other employment rights      4  
8.1   Discretion of Board      4  
8.2   Calculation of employee benefits      4  
8.3   No right to future employment or engagement      4  
8.4   Acknowledgment by Participant      4  
9.   Attorney      5  
10.   Powers of the Board      5  
10.1   Powers of the Board      5  
10.2   Indemnification      5  
10.3   Resolution to terminate, suspend, supplement or amend      6  
11.   General      6  
11.1   Severability      6  
11.2   Consents and approvals      6  
11.3   Governing law and jurisdiction      6  
11.4   Conflicting provisions      6  

 

i


12.   Definitions and interpretation      6  
12.1   Definitions      6  
12.2         Interpretation      8  
Schedule 1 : Application Form      10  

 

ii


Employee Share Plan

 

Date adopted    7 January 2016

 

1.

The Plan

 

1.1

Purpose

The purpose of this Plan is to provide “Eligible Employees” (who may be an employee of, consultant to, or Director of the Group) with an incentive to remain with the Group and to improve the longer-term performance of the Group and its returns to shareholders. It is intended that this Plan will enable the Group to retain and attract skilled and experienced staff and provide them with the motivation to make the Group more successful.

 

1.2

Commencement

This Plan will take effect on and from such date as the Board may resolve.

 

1.3

Termination or suspension of Plan

 

  (a)

The Board may terminate or suspend the operation of this Plan at any time.

 

  (b)

If this Plan is terminated or suspended under clause 1.3(a) for any reason, the termination does not prejudice any rights of the Participants which have accrued up to the time this Plan is terminated or suspended. For clarity where any Shares or entitlements have been issued prior to the date of termination or suspension, those Shares and entitlements (as the case may be) will continue in full force on the terms of the plan as at the date of termination or suspension.

 

1.4

Connection with other plans

Unless the Board otherwise determines, participation in this Plan does not affect, and is not affected by, participation in any other incentive or other plan operated by the Company unless the terms of that other plan provide otherwise.

 

2.

Eligibility

 

2.1

Participation by Eligible Employees

The Board may determine at any time that any Eligible Employee is not entitled to participate in this Plan if the Eligible Employee’s participation would be unlawful.

 

2.2

Overseas Eligible Employees

At the Board’s discretion, the Company may:

 

  (a)

allot or issue Shares to Participants who are resident outside of Australia; and

 

  (b)

make regulations for the operation of this Plan which are not inconsistent with this Plan to apply to Participants who are resident outside of Australia.

 

1


3.

Participation

 

3.1

Invitation to participate

Subject to this Plan, the Board may invite any Eligible Employee selected by it to complete an Application Form relating to a specified number of Shares allocated to that Eligible Employee by the Board.

 

3.2

Application Form

The Board (or where a Loan is provided by a company in the Group, the Board of that company) must give to each Eligible Employee invited to complete an Application Form, an Application Form together with the following information relating to the Shares allocated to the Eligible Employee:

 

  (a)

the name of the Eligible Employee;

 

  (b)

the date of allocation or intended date of allocation;

 

  (c)

the total number of Shares to be allocated;

 

  (d)

the Acquisition Price;

 

  (e)

where a Loan is provided, a Loan Agreement containing the terms and conditions of the Loan as determined by the Board (or the Board of the company in the Group which provides a Loan);

 

  (f)

any other terms and conditions relating to the Shares which, in the opinion of the Board, are fair and reasonable but not inconsistent with this Plan; and

 

  (g)

any other information or documents required to be notified by the Corporations Act.

 

3.3

Participant bound by Application Form, Plan and Constitution

By completing and returning the Application Form, a Participant irrevocably agrees to be bound by the terms of the Application Form, this Plan and the Constitution.

 

4.

Allocation of Shares

 

4.1

Allocation of Shares

The Board may allot and issue or transfer Shares to a Participant on acceptance of a duly signed and completed Application Form.

 

4.2

Method of consideration

The Board may determine the requisite form of consideration to purchase Shares, which may include cash, electronic funds transfer or Loan or any combination of them.

 

4.3

Holding Statements

The Company must procure the issue of a holding statement to a Participant in respect of the Shares issued to that Participant.

 

2


5.

Issue of Shares

The number of Shares held by Participants pursuant to the Plan at any time must not exceed 10% of the total number of issued Shares in the Company at the relevant time.

 

6.

Nature of Shares

 

6.1

General

Subject to the terms of any applicable Loan (if any), a Participant is entitled to any rights which accrue to Shares held by the Participant and may accept the rights and sell or otherwise deal with those rights in accordance with this Plan and the Application Form.

 

6.2

Ranking

The Shares will rank equally with all other fully paid ordinary shares on issue in the capital of the Company.

 

6.3

Voting

Holders of Shares issued under this Plan will be entitled to exercise all voting rights attaching to the Shares in accordance with the Company’s constitution.

 

6.4

Entitlement to dividends

Holders of Shares issued under this Plan will be entitled to participate in dividends declared and paid by the Company in accordance with the rights attaching to the Shares and the Company’s constitution.

 

6.5

Transfer restrictions on Shares

Other than as provided by this Plan, the Company must not register or permit registration of or a transfer of a Share unless and until the Shares have Vested and, for that purpose, the Company may do all acts and things necessary to enforce any restrictions on the transfer of any Share and the relevant Participant is bound by those restrictions.

 

7.

Buyback or Sale of Shares

 

7.1

Unfulfilled Vesting Condition

Where a Vesting Condition in relation to the Shares is not satisfied by the due date, or becomes incapable of satisfaction in the opinion of the Board, the Company must, unless the Vesting Condition is waived by the Board and subject to the Corporations Act and the ASX Listing Rules, either:

 

  (a)

buy back and cancel the relevant Shares within 12 months of the date the Vesting Condition was not satisfied (or became incapable of satisfaction) under Part 2J.1 of the Corporations Act at a price equal to the cash consideration paid by the Participant for the Shares; or

 

  (b)

arrange to sell the Shares as soon as reasonably practicable either on the ASX or to an investor who falls within an exemption under Section 708 of the Corporations Act provided that the sale must be at a price that is no less than

 

3


  80% of the volume weighted average price at which Shares were traded on the ASX on the 10 trading days up to and including the trading day before the sale date, and apply the sale proceeds (Sale Proceeds) in the following priority:

 

  (i)

first, to pay the Company any outstanding Loan Amount (if any) in relation to the Shares and the Company’s reasonable costs in selling the Shares;

 

  (ii)

second, to the extent the Sale Proceeds are sufficient, to repay the Participant any cash consideration paid by the Participant or Loan Amount repayments (including any cash dividends applied to the Loan Amount) made by or on behalf of the Participant; and

 

  (iii)

lastly, any remainder to the Company to cover its costs of managing the Plan.

 

7.2

Ceasing Employment before Restriction Conditions satisfied

Where the person who was initially offered the Shares ceases to be an Eligible Employee and, at that time, there are Vesting Conditions in relation to those Shares that are unsatisfied or are incapable of satisfaction in the opinion of the Board (and they are not waived), unless the Participant becomes a Good Leaver, the Company must, subject to the Corporations Act and the ASX Listing Rules, buy back and cancel or sell the Shares in accordance with clause 7.1 of this Plan.

 

8.

Contracts of employment and other employment rights

 

8.1

Discretion of Board

It is a condition of this Plan that this Plan may be terminated at any time at the discretion of the Board and that no compensation under any employment contract will arise as a result.

 

8.2

Calculation of employee benefits

The value of the Shares does not increase a Participant’s income for the purpose of calculating any employee benefits.

 

8.3

No right to future employment or engagement

Participation in this Plan does not confer on any Participant any right to future employment or engagement and does not affect any rights which the Company may have to terminate the employment or engagement of any Participant.

 

8.4

Acknowledgment by Participant

It is acknowledged and accepted by each Participant that the terms of this Plan do not form part of the terms and conditions of the Participant’s employment or other engagement contract, nor do the terms of this Plan constitute a contract or arrangement (including any related condition or collateral arrangement) in relation to the Participant’s employment or other engagement contract.

 

4


9.

Attorney

By completing and signing the Application Form the Participant irrevocably appoints the person who from time to time occupies the position of secretary of the Company or relevant company in the Group (where that company in the Group provides the Loan) (or the secretary’s authorised delegate) as his or her attorney to complete and execute any documents, including share transfers, and to do all acts or things in his or her name on his or her behalf which may be necessary for the purpose of giving effect to this Plan, including power

 

  (a)

to transfer the shares which are the subject of the Application to a nominee of the Company or relevant company in the Group (where that company in the Group provides the Loan) at the Acquisition Price per Share, or

 

  (b)

for the Company to undertake a buy back (at the Issue Price per Share) or capital reduction of those Shares pursuant to the provisions of the Corporations Act 2001,

upon the basis that the Application Form is an irrevocable direction to the Company (either on its own behalf or on behalf of a company in the Group (where that company in the Group provides the Loan)) to apply all proceeds that would have otherwise been provided or due to the Participant on a transfer, buy back or capital reduction of the Loan Shares solely in satisfaction of the Outstanding Loan Balance.

 

10.

Powers of the Board

 

10.1

Powers of the Board

This Plan will be managed by the Board, which will have power to:

 

  (a)

determine appropriate procedures for the administration of this Plan consistent with this clause 10.1;

 

  (b)

resolve conclusively all questions of fact or interpretation arising in connection with this Plan;

 

  (c)

determine matters falling for determination under this clause 10.1 in its discretion having regard to the interests of and for the benefit of the Company;

 

  (d)

exercise the discretions conferred on it by this clause 10.1 or which may otherwise be required in relation to this Plan, including determination of the Acquisition Price; and

 

  (e)

delegate to any one or more persons (for such period and on such conditions as it may determine) the exercise of any of its powers or discretions arising under this Plan.

 

10.2

Indemnification

The Company must indemnify, and keep indemnified, to the full extent permitted by law, each person who is or has been a director or alternate director of the Company against all proceedings, actions, claims, demands, losses, liabilities, damages, costs and expenses which may be made, brought against, suffered or incurred by the person arising directly or indirectly out of or in connection with the administration of this Plan.

 

5


10.3

Resolution to terminate, suspend, supplement or amend

The Board has absolute and final determination in passing a resolution to terminate or suspend the operation of this Plan or to supplement or amend this Plan in any way that the Board determines appropriate.

 

11.

General

 

11.1

Severability

Any provision of this Plan which is invalid in any jurisdiction must, in relation to that jurisdiction:

 

  (a)

be read down to the minimum extent necessary to achieve its validity, if applicable; and

 

  (b)

be severed from this Plan in any other case,

without invalidating or affecting the remaining provisions of this Plan or the validity of that provision in any other jurisdiction.

 

11.2

Consents and approvals

Where anything depends on the consent or approval of a party then, unless this Plan provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

11.3

Governing law and jurisdiction

 

  (a)

This Plan is governed by and must be construed in accordance with the laws in force in the State of Western Australia and the Commonwealth of Australia.

 

  (b)

The parties submit to the non-exclusive jurisdiction of the courts of that State and the Commonwealth of Australia in respect of all matters arising out of or relating to this Plan, its performance or subject matter.

 

11.4

Conflicting provisions

If there is any conflict between the main body of this Plan and any schedules or annexures comprising it, then the provisions of the main body of this Plan prevail.

 

12.

Definitions and interpretation

 

12.1

Definitions

In this Plan:

Acquisition Price means the issue price of the Shares pursuant to the Plan as determined by the Board at their absolute discretion, being a price per Share as determined by the Board (in its discretion) as at the time of the proposed issue of the Loan Shares which equates to an arm’s length market price, taking into account among other factors (i) recent trading volumes, (ii) the price at which Shares traded over the relevant period and (iii) other factors determined by the Board to be relevant;

 

6


Application Form means the form that the Board determines is to be used by an Eligible Employee to apply for Shares under this Plan as set out in Schedule 1;

Bad Leaver means a Participant who ceases employment, engagement or office with any Group Company in any of the following circumstances:

 

  (a)

the Participant’s employment or engagement is terminated, or the Participant is dismissed from office, due to:

 

  (i)

serious and wilful misconduct;

 

  (ii)

material breach of the terms of any contract of employment, engagement or office entered into by the Company (or another Group Company) and the Participant;

 

  (iii)

gross negligence; or

 

  (iv)

other conduct justifying termination of employment, engagement or office without notice either under the Participant’s contract of employment, engagement or office, or at common law;

 

  (b)

the Participant ceases his or her employment, engagement or office for any reason and commences employment, engagement or office, or otherwise acts, in breach of any post-termination restrictions contained in his or her contract of employment, engagement or office entered into by the relevant Group and the Participant; or

 

  (c)

the Participant is ineligible to hold his or her office for the purposes of Part 2D.6 of the Corporations Act.

Board means the board of directors of the Company or a committee appointed by the board of directors of the Company;

Business Day means a day that is not a Saturday, Sunday, public holiday or bank holiday in Melbourne, Victoria;

Company means Avita Medical Limited ACN 058 466 523 of Level 9, The Quadrant, 1 William Street, Perth, Western Australia;

Constitution means the constitution of the Company as may be amended from time to time;

Corporations Act means the Corporations Act 2001 (Cth);

Directors means the directors of the Company;

Eligible Employee means an employee of, consultant to, or a Director or any member of the Group;

Employee Share Scheme has the meaning provided under the Corporations Act;

Good Leaver means a Participant who not a Bad Leaver and ceases employment, engagement or office with any Group Company due to:

 

  (a)

death or Total or Permanent Disability;

 

7


  (b)

bona fide Retirement from the workforce (unless the Retirement happens within six (6) months of the date of the issue of the Plan Shares);

 

  (c)

bona fide Redundancy;

 

  (d)

Severe Financial Hardship;

 

  (e)

death of an immediate family member of the Participant (or Eligible Participant, as applicable);

 

  (f)

substantial change in circumstances, out of the control of the Participant (or Eligible Participant, as applicable) which affects the ability of the Participant (or Eligible Participant, as applicable) to perform his or her role with a Group Company;

 

  (g)

terminal illness of the Participant (or Eligible Participant); or

 

  (h)

or any other reason the Board determines in its sole and absolute discretion.

Group means the Company and each Related Body Corporate of the Company;

Loan means a loan made by the Company or a company in the Group to an Eligible Employee in for the purposes of the acquisition of Loan Shares by a Participant;

Loan Agreement means any loan agreement between the Company or company in the Group and the Eligible Employee evidencing the terms and conditions of the Loan;

Loan Share means a Share acquired with a Loan which has not been repaid in full in accordance with the terms of the Loan Agreement;

Participant means an Eligible Employee (who may be an employee of, consultant to, or a director of the Group) who has been invited to participate in this Plan and any other person who is nominated by that Eligible Employee and who is determined by the Board to be a Participant for the purposes of this Plan;

Plan means this plan including the background, any schedules and any annexures;

Related Body Corporate has the meaning given to that term in the Corporations Act;

Shares means fully paid ordinary shares in the capital of the Company or any other securities issued in accordance with this Plan as the context requires; and

Vested means, in relation to a Share, that the relevant Participant is entitled to become the registered holder of that Share under clause 6.5 as a result of satisfaction of a Vesting Condition and Vesting has a corresponding meaning.

Vesting Condition means any condition prescribed by the Company that must be satisfied before the Shares are Vested.

 

12.2

Interpretation

In this Plan, unless the context requires otherwise:

 

  (a)

the singular includes the plural and vice versa;

 

  (b)

a gender includes the other genders;

 

8


  (c)

the headings are used for convenience only and do not affect the interpretation of this Plan;

 

  (d)

other grammatical forms of defined words or expressions have corresponding meanings;

 

  (e)

a reference to a document includes the document as modified from time to time and any document replacing it;

 

  (f)

a reference to a party is to a party to this Plan and a reference to a party to a document includes the party’s executors, administrators, successors and permitted assigns and substitutes;

 

  (g)

if something is to be or may be done on a day that is not a Business Day then it must be done on the next Business Day;

 

  (h)

the word “person” includes a natural person, partnership, body corporate, association, governmental or local authority, agency and any body or entity whether incorporated or not;

 

  (i)

the word “month” means calendar month and the word “year” means 12 months;

 

  (j)

the words “in writing” include any communication sent by letter, facsimile transmission or email or any other form of communication capable of being read by the recipient;

 

  (k)

a reference to a thing includes a part of that thing;

 

  (l)

a reference to all or any part of a statute, rule, regulation or ordinance (statute) includes that statute as amended, consolidated, re-enacted or replaced from time to time;

 

  (m)

wherever “include”, “for example” or any form of those words or similar expressions is used, it must be construed as if it were followed by “(without being limited to)”;

 

  (n)

money amounts are stated in Australian currency unless otherwise specified;

 

  (o)

a reference to time is to Melbourne, Victoria time;

 

  (p)

a reference to any agency or body, if that agency or body ceases to exist or is reconstituted, renamed or replaced or has its powers or functions removed (defunct body), means the agency or body which performs most closely the functions of the defunct body;

 

  (q)

any agreements, representation, warranty or indemnity in favour of two or more parties (whether those parties are included in the same defined term or not) is for the benefit of them jointly and separately; and

 

  (r)

any agreements, representation, warranty or indemnity by two or more parties (whether those parties are included in the same defined term or not) binds them jointly and separately.

 

9


Schedule 1: Application Form

 

10

EX-4.3

EXHIBIT 4.3

 

LOGO

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. Double asterisks denote omissions. AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER. UNDER DPAS (15 CFR 700) RATING PAGE OF PAGES 1 I 4 6 2. CONTRACT (Proc. Inst. Ident.) NO. HHSO100201500028C 3. EFFECTIVE DATE See Block 20C 4. REQUISITION/PURCHASE REQUEST/PROJECT NO. OS164565 5. ISSUED BY CODE ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 202016 ASPR—BARDA 6. ADMINISTERED BY (If other than Item 5) CODE See Block 5 ASPR—BARDA    7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State end ZIP Code) AVITA MEDICAL AMERICAS, LLC 1476585 9221 CORBIN AVE STE 220 NORTHRIDGE CA 91324 8. DELIVERY     â–¡ FOB ORIGIN â–¡ In OTHER (See below)9 9. DISCOUNT FOR PROMPT PAYMENT 10. SUBMIT INVOICES (4 copies unless otherwise specified) TO THE ADDRESS SHOWN IN ITEM CODE 1476585 FACILITY CODE    11. SHIP TO/MARK FOR CODE HHS/OS/ASPR 200 C SW WASHINGTON DC 20201 HHS/OS/ASPR    12. PAYMENT WILL BE MADE BY CODE PSC Program Support Center 5600 Fishers Lane Room 17--21 Rockville MD 20852 PSC    13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: â–¡ 10 U.S.C. 2304 (c) ( ) â–¡ 41 U.S.C. 253(c) ( ) 14. ACCOUNTING AND APPROPRIATION DATA 2015.1990002.26201 15A. ITEM NO 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT Continued    15G. TOTAL AMOUNT OF CONTRACT $16,901,424.00 16. TABLE OF CONTENTS (x) SEC Description Page(s) (x) SEC Description Page(s) PART I—THE SCHEDULE PART II—CONTRACT CLAUSES X A SOLICITATION/CONTRACT FORM . 01 X I CONTRACT CLAUSES 39 X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART Ill -LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. X C DESCRIPTION/SPECS./WORK STATEMENT 10 X J LIST OF ATTACHMENTS 46 X O PACKAGING AND MARKING 11 PART IV—REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND ACCEPTANCE 12 K LIST OF ATTACHMENTS X F DELIVERIES OR PERFORMANCE 13    X G CONTRACT ADMINISTRATION DATA 23 L INSTRS., CONDS., AND NOTICES TO OFFERORS X H SPECIAL CONTRACT REQUIREMENTS 27 M EVALUATION FACTORS FOR AWARD CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18. (SEALED-BID PROCUREMENT} AS APPLICABLE 17. â–¡ CONTRACTOR’S AGREEMENT (Contractor is required to sign this document and return copies to issuing office. Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents. (a) this award/contract, (b) the solicitation, if any, and (c) such problems, representations, certifications, and specifications as are attached or incorporated by reference herein. (Attachments are listed herein) 18. â–¡ SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on Solicitation Number                 including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the Items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents. (a) the Government’s solicitation and your bid, and (b) this award/contract. No further contractual document is necessary. (Block 10 should be checked only when awarding a sealed-bid contract.) 19A NAME AND TITLE OF SIGNE (Type or print) 20A. NAME OF CONTRACTING OFFICER 19B. NAME OF CONTRACTOR BY Timothy Rooney CFO/COO /s/ Timothy Rooney (Signature of person authorized to sign) 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA BY Brooke Bernold /s/ Brooke Bernold (Signature of the Contracting Officer) 20C. DATE SIGNED 29 Sept, 2015 AUTHORIZED FOR REPRODUCTION Previous edition is NOT usable

 

Page 1 of 50


LOGO

AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER. UNDER DPAS (15 CFR 700) RATING PAGE OF PAGES 1 I 4 6 2. CONTRACT (Proc. Inst. Ident.) NO. HHSO100201500028C 3. EFFECTIVE DATE See Block 20C 4. REQUISITION/PURCHASE REQUEST/PROJECT NO. OS164565 5. ISSUED BY CODE ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 202016 ASPR—BARDA 6. ADMINISTERED BY (If other than Item 5) CODE See Block 5 ASPR—BARDA    7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State end ZIP Code) AVITA MEDICAL AMERICAS, LLC 1476585 9221 CORBIN AVE STE 220 NORTHRIDGE CA 91324 8. DELIVERY    â–¡ FOB ORIGIN â–¡ In OTHER (See below)9 9. DISCOUNT FOR PROMPT PAYMENT 10. SUBMIT INVOICES (4 copies unless otherwise specified) TO THE ADDRESS SHOWN IN ITEM CODE 1476585 FACILITY CODE    11. SHIP TO/MARK FOR CODE HHS/OS/ASPR 200 C SW WASHINGTON DC 20201 HHS/OS/ASPR    12. PAYMENT WILL BE MADE BY CODE PSC Program Support Center 5600 Fishers Lane Room 17--21 Rockville MD 20852 PSC    13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:    â–¡ 10 U.S.C. 2304 (c) ( ) â–¡ 41 U.S.C. 253(c) ( ) 14. ACCOUNTING AND APPROPRIATION DATA 2015.1990002.26201 15A. ITEM NO 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT Continued    15G. TOTAL AMOUNT OF CONTRACT $16,901,424.00 16. TABLE OF CONTENTS (x) SEC Description Page(s) (x) SEC Description Page(s) PART I—THE SCHEDULE PART II—CONTRACT CLAUSES X A SOLICITATION/CONTRACT FORM . 01 X I CONTRACT CLAUSES 39 X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART Ill -LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. X C DESCRIPTION/SPECS./WORK STATEMENT 10 X J LIST OF ATTACHMENTS 46 X O PACKAGING AND MARKING 11 PART IV—REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND ACCEPTANCE 12 K LIST OF ATTACHMENTS X F DELIVERIES OR PERFORMANCE 13    X G CONTRACT ADMINISTRATION DATA 23 L INSTRS., CONDS., AND NOTICES TO OFFERORS X H SPECIAL CONTRACT REQUIREMENTS 27 M EVALUATION FACTORS FOR AWARD CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18. (SEALED-BID PROCUREMENT} AS APPLICABLE 17. â–¡ CONTRACTOR’S AGREEMENT (Contractor is required to sign this document and return copies to issuing office. Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents. (a) this award/contract, (b) the solicitation, if any, and (c) such problems, representations, certifications, and specifications as are attached or incorporated by reference herein. (Attachments are listed herein) 18. â–¡ SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on Solicitation Number                 including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the Items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents. (a) the Government’s solicitation and your bid, and (b) this award/contract. No further contractual document is necessary. (Block 10 should be checked only when awarding a sealed-bid contract.) 19A NAME AND TITLE OF SIGNE (Type or print) 20A. NAME OF CONTRACTING OFFICER 19B. NAME OF CONTRACTOR BY (Signature of person authorized to sign) 19C. DATE SIGNED 20B. UNITED STATES OF AMERICA BY (Signature of the Contracting Officer) 20C. DATE SIGNED AUTHORIZED FOR REPRODUCTION Previous edition is NOT usable

 

Page 2 of 50


CONTINUATION SHEET    REFERENCE NO. OF DOCUMENT BEING CONTINUED    PAGE      OF
   HHSO100201500028C    2    46

NAME OF OFFEROR OR CONTRACTOR

AVITA MEDICAL AMERICAS, LLC 1476585

 

ITEM NO.

(A)

  

SUPPLIES/SERVICES

(B)

  

QUANTITY

(C)

  

UNIT

(D)

  

    UNIT PRICE    

(E)

  

        AMOUNT        

(F)

  

Tax ID Number: 20-2578762

DUNS Number: 026723570

Autograft-Sparing Products for Definitive Care of

Burn Injuries

Appr. Yr.: 2015 CAN: 1990002 Object Class: 26201

FOB: Destination

           
1   

ASPR-15-08829 — CLIN 0001 Advanced Development Studies for Licensure Approval of ReCell

POP: [**]/2015 – [**]/2020

Obligated Amount: [**]

            [**]
2   

ASPR-15-08829 — CLIN 0002 Initial Purchase, Storage, and Delivery of ReCell Devices

POP: [**]/2015 – [**]/2020

Obligated Amount: [**]

            [**]
AUTHORIZED FOR REPRODUCTION            

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53. 110

 

Page 3 of 50


PART I – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Avita Medical is developing ReCell, a unique technology that enables clinicians to use a small sample of your skin to restore healthy, normal skin when treating partial thickness or full thickness burns. The product has the potential to greatly improve the patient’s quality of life while reducing hospital stays and the need for reconstructive surgery. This product could find utility in day-to-day care, while simultaneously improving our capability to respond to mass casualty incidents.

Under the base period-of-performance, Avita Medical will further enhance their product to improve its commercial viability through the FDA approval process and potentially complete an initial purchase, storage, and delivery of product. The contract options may be exercised to perform follow-on studies as directed by the FDA, perform additional studies which further extend the ability to protect children and the elderly population, and purchase additional treatment courses.

The Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and several options as specified in this contract. The period of performance for the base period is [**] months.

ARTICLE B.2. BASE PERIOD

 

CLIN

  

Period of

Performance

  

Supplies/ Services

  

Total Est.
Cost

   Fixed Fee
(7%)
  

Total Cost

Plus Fixed

Fee

 

COST REIMBURSEMENT

 

0001 (Base)    [**]/2015 – [**]/2020    Licensure, approval, and clearance of product through the FDA    [**]    [**]    [**]

 

FIRM FIXED PRICE

 

CLIN

  

Period of

Performance

  

Supplies/ Services

  

Units (# of
Product)

   Unit Price
($)
  

Total ($)

0002    [**]/2015 – [**]/2020    Initial Purchase, storage, and delivery of product    [**]    [**]    [**]
Total CLINS 1&2    [**]/2015 – [**]/2020    See Above Descriptions          [**]

 

Page 4 of 50


ARTICLE B.3. OPTION PRICES

 

CLIN

  

Period of
Performance

  

Supplies/Services

  

Units (# of
Product)

  

Unit Price ($)

  

Total ($)

 

FIRM FIXED PRICE

 

0003 (Option Quantity)    36 Months    Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)    N/A    N/A    [**]

 

COST REIMBURSEMENT

 

0004 (Option Quantity)    60 Months    Pediatric Study (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)    [**]    [**]    [**]

 

FIRM FIXED PRICE

 

0005A (Option Quantity)    36 Months    Additional Surge Capacity    [**]    [**]    [**]
0005A (Option Quantity)    36 Months    Additional Surge Capacity    [**]    [**]    [**]
0005A (Option Quantity)    36 Months    Additional Surge Capacity    [**]    [**]    [**]
0005A (Option Quantity)    36 Months    Additional Surge Capacity    [**]    [**]    [**]
Total CLINs 3-5    60 Months    See Above Descriptions          [**]

ARTICLE B.4. LIMITATIONS APPLICABLE TO DIRECT COSTS

 

a.

Items Unallowable Unless Otherwise Provided

Notwithstanding the clause FAR 52.216-7, Allowable Cost and Payment, incorporated in this contract, the costs of the following items or activities shall be unallowable as direct costs unless authorized in writing in advance by the Contracting Officer:

 

  1.

Acquisition, by purchase or lease, of any interest in real property;

 

  2.

Special rearrangement or alteration of facilities;

 

Page 5 of 50


  3.

Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

 

  4.

Travel to attend general scientific meetings;

 

  5.

Unapproved foreign travel;

 

  6.

Consultant costs;

 

  7.

Subcontracts;

 

  8.

Patient care costs;

 

  9.

Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value.

 

  10.

Printing Costs (as defined in the Government Printing and Binding Regulations).

 

  11.

Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility.

 

  12.

Meeting room or conference space used for face to face meetings with USG staff in the performance of this contract. Justification for why the meeting cannot be held at a government facility must be provided. COA requests must be made at least (2) two weeks prior to meeting date.

 

b.

Travel Costs

 

  1.

Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred by the Prime Contractor in direct performance of this contract shall not exceed [**] without prior advance written approval by the Contracting Officer. Costs must be consistent with FAR 52.247-63 – Preference for U.S.-Flag Air Carriers.

 

  2.

The Contactor shall invoice and be reimbursed for all travel costs in accordance with FAR 31.703 and FAR 31.205-46, Contracts with Commercial Organizations, Travel Costs.

 

Page 6 of 50


  3.

Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following:

 

  (i)

Meeting(s) and place(s) to be visited, with costs and dates;

 

  (ii)

Names(s) and title(s) of Contractor personnel to travel and their functions in the contract project;

 

  (iii)

Contract purpose to be served by the travel;

 

  (iv)

How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of AMCG contract funds;

 

  (v)

How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and

 

  (vi)

What additional functions may be performed by the travelers to accomplish other purpose of the contact and thus further benefit the project.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

 

a.

Subcontracts and Consultants

Award of any FFP subcontract or FFP consulting agreement in excess of $150,000 or any cost reimbursement subcontract or consulting agreement shall not proceed without the prior written consent of the Contracting Officer via a Contracting Officer Authorization (COA) Letter. COA letters will only be issued upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer within ten (10) days.

 

b.

Site Visits, Inspections and General Audits

At the discretion of the USG and independent of activities conducted by the Contractor, with 48 hours’ notice to the Contractor, the USG reserves the right to conduct site visits and inspections on an as needed basis, including collection of product samples and intermediates held by the Contractor, or subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall demonstrate cause for such visit and/or inspection. All costs reasonably incurred by the Contractor and subcontractor for such visit and/or inspection shall be allowable costs. The Contractor shall coordinate these visits and shall have the opportunity to accompany the USG on any such visits. Under time-sensitive or critical situations, the USG reserves the right to suspend the 48 hour notice to the Contractor. If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government for review and acceptance.

 

   

If issues are identified during the audit, Contractor shall submit an issues report to the CO and COR within 10 business days detailing the finding and corrective action(s) of the audit.

 

   

COR and CO will review the issues report and provide a response to the Contractor within 10 business days.

 

   

Once corrective action is completed, the Contractor will provide a final report to the CO and COR within a time frame negotiated with the COR in writing after review of the issues report.

 

Page 7 of 50


c.

QA Audits

BARDA reserves the right to participate in QA audits performed by the Contractor. Upon completion of the QA audit the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor, detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

 

   

Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications.

 

   

Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings.

 

d.

Man-in-Plant

At the discretion of the Government and seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility, who shall be subject to the Contractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s facility. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor plant.

 

e.

Confidential Treatment of Sensitive Information

The Contractor shall, to the extent permitted by law, guarantee strict confidentiality of the information/data that is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Notwithstanding the foregoing, such information/data shall not be deemed of a sensitive nature with respect to the Contractor for purposes of this contract if such information/data: (a) was already known to the Contractor; (b) was generally available or known, or was otherwise part of the public domain, at the time of its disclosure to the Contractor; (c) became generally available or known, or otherwise became part of the public domain, after its disclosure to, or, with respect to the information/data by, the Contractor through no fault of the Contractor; (d) was disclosed to the Contractor, other than under an obligation of confidentiality or non-use, by a third party who had no obligation to the Government that controls such information/data not to disclose such information/data to others; or (e) was independently discovered or developed by the Contractor, as evidenced by its written records, without the use of information/data belonging to the Government.

 

Page 8 of 50


The Contractor may disclose information/data of a sensitive nature provided by the Government to the extent that such disclosure is: (a) made in response to a valid order of a court of competent jurisdiction (b) otherwise required by law, (c) made by the Contractor to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information/data

 

f.

Emergency Use Authorization (EUA)

The Contractor shall be responsible for generating the data to support the USG’s filing of a Pre-Emergency Use Authorization (Pre-EUA) package for use of the product prior to FDA licensure or approval during a declared emergency, declared potential emergency, or identification of material threat under an Emergency Use Authorization (EUA).

The Contractor commits to supporting the potential use of the product under a pre-EUA package as submitted by BARDA or the CDC/SNS. The Contractor shall supply BARDA or the CDC/SNS with the data needed to support such a submission, including expanded access INDs, right to hold product, right of reference to the Contractor’s Investigational New Drug (IND), or other application that contains the supporting data. The Contractor shall address any FDA comments on all pre-EUA packages as applicable. The Contractor shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder, etc.), that will be used to support use under EUA and approval/licensure.

Any product which has not received FDA approval or licensure, but has completed submission of the Pre-EUA package and has met the three (3) criteria listed below may be considered for procurement at the discretion of the USG. The Contractor would be required to demonstrate the three (3) essential criteria listed below for consideration of procurement of any unapproved products by seeking a COA. The COA shall include a product delivery schedule for consideration and documentation of the following:

 

   

Substantial evidence, including a validated process, of the Contractor’s ability to manufacture a product that would be identical to the commercial scale as required for product approval or licensure. A clear understanding of the outstanding risks, if any, for approval or licensure must be demonstrated through a risk register.

 

   

Completion of pivotal clinical studies with substantial evidence of safety and efficacy for the indicated use. A list of outstanding activities and targets for completion, adverse events/safety profile which do not pose unusual risks or challenges for FDA approval or licensure shall be provided.

 

   

Substantial evidence of product familiarity/acceptance for use in burn centers. The Contractor shall provide a list of burn centers familiar with the product, feedback received, and corrective actions required to address any concerns to ensure effective use of the product by burn care providers unfamiliar with the product. Evidence of the company’s ability to educate such providers on the use of the product (as allowed within the constraints of law) will be useful.

A tentative delivery schedule of product delivery to the inventory (acceptable as in the Quality Agreement) shall be required as part of the COA. The delivery schedule shall be updated periodically as necessary.

 

Page 9 of 50


For information concerning EUA, please consult http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127 and
http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/ MCMLegalRegulatoryandPolicyFramework/ucm182568.htm

 

g.

Sharing of contract deliverables within United States Government (USG)

In an effort to build a robust medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense and the National Institutes of Health, BARDA may share technical deliverables and data created in the performance of this contract with colleagues within the Integrated Portfolio. This advance understanding does not authorize BARDA to share financial information outside HHS. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the Government’s rights to deliverables submitted during performance as well as the Government’s rights to data contained within those deliverables.

 

h.

Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract. Billing of actual hours should be limited to total productive hours in a month.

 

i.

Option CLINS

The USG reserves the right to re-negotiate the option CLINS based availability of funds and feedback received from the FDA.

 

j.

Contract Number Designation

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:

HHSO100201500028C

 

k.

Quality Agreement

The Quality Agreement shall define, establish, and document the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. These documents shall be drafted, approved, and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement.

 

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated September 29, 2015 set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.

ARTICLE C.2. REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

All reports required herein shall be submitted in electronic format. All paper/hardcopydocuments/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

ARTICLE C.3. TWICE MONTHLY CONFERENCE CALLS

A conference call between the Contracting Officer’s Representative (COR) and the Contractor’s Project Leaders/delegates and designees shall occur twice-monthly or as directed by the Contracting Officer and Contracting Officer’s Representative. During this call the Contractor’s Project Leaders/delegates and designees will discuss the activities since the last call, any problems that have arisen and the activities planned until the next call takes place. The Contractor’s Project Leaders/delegates may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Representative.

ARTICLE C.4. PROJECT MEETINGS

The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative. These meetings may include face-to-face meetings with AMCG/BARDA in Washington, D.C. and at work sites of the Contractor. Such meetings may include, but are not limited to, meetings of the Contractor to discuss study designs, site visits to the Contractor’s facilities, and meetings with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. Subject to the data rights provisions in this contract, the Contractor will provide data, reports, and presentations to groups of outside experts and USG personnel as required by the Contracting Officer and Contracting Officer’s Representative in order to facilitate review of contract activities.

 

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the date, contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

 

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SECTION E - INSPECTION AND ACCEPTANCE

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided under this contract.

For the purpose of this SECTION E, the designated Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer. The COR will assist in resolving technical issues that arise during performance. The COR however is not authorized to change any contract terms or authorize any changes in the Statement of Work or modify or extend the period of performance, or authorize reimbursement of any costs incurred during performance. The Contractor is advised to review FAR 52.243-1 Changes – Fixed Price Contracts Alternate V and FAR 52.243-2 Changes-Cost reimbursement contracts Alternative V, which is incorporated by reference into this contract in ARTICLE I.1.

Inspection and acceptance will be performed at:

Office of Acquisition Management, Contracts, and Grants (AMCG)

Office of the Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

200 C St. SW

Washington, D.C. 20024

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

The contract incorporates the following clause by reference with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

 

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance for this contract shall be from September 29, 2015 through September 28, 2020. The period of performance for the base period of this contract shall be consistent with the dates set forth in SECTION B. If the Government exercises option(s), the period of performance will be extended as described under in SECTION B of this contract.

ARTICLE F.2. REPORTING REQUIREMENTS

In all cases the reports are intended to provide sufficient detail to understand the Contractor’s approach and progress to addressing the technical requirements. The reports supplement, and do NOT replace, routine (i.e. daily) communication between the COR and project manager and/or their designee(s) regarding project plans and progress.

 

  A.

Monthly Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance updates as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

 

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SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT — This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

Invoices: Summary of any invoices submitted during the reporting period.

A Monthly Progress Report will not be required in the same months that Annual or Final Technical Progress Reports are due.

 

  B.

Annual Progress Report

This report shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year.

The Contractor shall submit an Annual Progress Report on or before the 30th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE — This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS — This section shall document the results of work completed and costs incurred during the period covered in relation to proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

 

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SECTION II Part D: ISSUES — This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK — This section shall include a summary of work proposed as an annual forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT — This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

Invoices: Summary of any invoices submitted during the reporting period.

An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due.

 

  C.

Draft Final Report and Final Report

These reports are to include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Progress Report shall be due forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report is due no later than 30 calendar days following the expiration date of the contract. The report shall conform to the following format:

Title Page: The title for these reports shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.

SECTION II: RESULTS - A detailed description of the work performed and the results obtained including all expenses for the entire contract period of performance.

 

  D.

FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions.

 

  a.

Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall provide a formal contact report to BARDA. The Contractor shall forward the final minutes when available.

 

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  b.

Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available and if applicable.

 

  c.

The Contractor shall forward the dates and times of any formal meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.

 

  d.

The Contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA.

 

  e.

The Contractor shall forward Standard Operating Procedures (SOPs) upon request from COR.

 

  f.

The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR.

 

  g.

The Contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all site visits/audits conducted by the FDA or any other regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

 

  E.

Other Requirements/Deliverables

 

  a.

Integrated Master Project Plan

The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to annual deliverables and Work Breakdown Structure (WBS) elements. Attention shall be placed on providing sufficient turnaround time for the USG (BARDA, FDA, and CDC) for review of critical documentation. The Contractor shall integrate to demonstrate interdependencies among all CLINS. The Integrated Master Project Plan shall be incorporated into any potential contract and will be used to monitor performance of the contract. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  i.

Critical Path Milestones

The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

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  ii.

Work Breakdown Structure

The USG has provided a Contract Work Breakdown Structure (CWBS) template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) and the Contractor shall further delineate the CWBS to Level 5 as part of their Integrated Master Project Plan. The WBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  iii.

Risk Mitigation Plan/Matrix

The Contractor shall develop and maintain a risk management plan that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan shall reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) to be completed by any prospective Contractor. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  b.

Technology Packages

Technology packages developed under the contract that includes complete protocols must be submitted at the request of the BARDA Contracting Officer’s Representative. See FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14, Rights in Data. This report shall be due upon request from the COR or Alternate COR.

 

  c.

Experimental Protocols

The Contractor shall submit to the COR all study/experiment/test plans, designs, and protocols prior to execution for BARDA approval or upon request by the COR or Alternate COR when required.

 

  d.

Annual/Final Invention Report

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer.

 

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  e.

Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission. Reports of final submission for publication shall be due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

 

  f.

Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than five (5) business days prior to the issuance of any potential press release.

 

  g.

Incident Security Report

The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products. Reports shall be due within 24 hours after occurrence of an activity or incident.

 

  i.

Security Plan

The Contractor shall submit a draft security plan within 90 days of contract award. A detailed security plan with any updates shall be submitted for approval at least three (3) months prior to the initiation of product procurement with proper documentation. The Contractor shall cooperate with USG representatives to develop a sustainable security plan to ensure continued security of the premises. Security plan updates are required when an incident security report has been filed.

 

  j.

Quality Management System (QMS) Plan

The Contractor shall provide a QMS plan within 90 days of contract award with updates at least three (3) months prior to initiation of product procurement and as directed by the COR or Alternate COR. The Contractor agrees to incorporate USG feedback and address concerns relating to QMS plans.

 

  k.

Quality Agreement

The Quality Agreement shall define, establish, and document the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. These documents shall be drafted, approved, and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement. Quality Agreement is due at least three (3) months prior to initiation of product procurement or as directed by the COR or Alternate COR.

 

  l.

Vendor Managed Inventory (VMI) Plan

The Contractor shall develop a plan to establish VMI in alignment with the Quality Agreement Report. Interim draft plans shall be submitted to USG as part of the development process. Draft submission for review is due upon completion of pre-EUA package. Final submission is required to initiate product procurement through a COA. Documents shall be updated as required by the COR or Co-COR. Developmental updates should be reported in the monthly reports as requested by the COR or Alternate COR.

 

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A minimum of three (3) product deliveries from different manufacturing lots shall be delivered and accepted by USG to the inventory (considered as substantial delivery to the inventory) before the Contractor shall invoice for the product payment.

 

  F.

Earned Value Management System Plan

 

  a.

Earned Value Management System Plan:

Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan as part of the monthly, annual, and final reports). The Seven Principles are:

 

  I.

Plan all work scope for the program to completion.

 

  II.

Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.

 

  III.

Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline.

 

  IV.

Use actual cost incurred and recorded in accomplishing the work performed.

 

  V.

Objectively assess accomplishments at the work performance level.

 

  VI.

Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.

 

  VII.

Use earned value information in the company’s management processes.

 

  VIII.

Elements of EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements.

 

  b.

Performance Measurement Baseline Review (PMBR):

The Contractor shall submit a PMBR plan electronically via email to the CO and COR for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout

 

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the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as FOLLOWS:

 

  I.

Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks.

 

  II.

Confirm the integrity of the Performance Measurement Baseline (PMB).

 

  III.

Foster the use of EVM as a means of communication.

 

  IV.

Provide confidence in the validity of Contractor reporting

 

  V.

Identify risks associated with the PMB.

 

  VI.

Present any revised PMBs for approval.

 

  VII.

Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).

 

  VIII.

Present the Risk Management Plan.

 

  c.

Integrated Master Schedule

The Contractor shall submit an IMS electronically via email as outlined in a format agreed upon by BARDA to the COR and the Contracting Officer for approval prior to the initiation of any activities of sufficient size and cost to require EVMS. The Integrated Master Schedule shall be incorporated into the contract, and shall be used to monitor performance of the contract. The Contractor shall include the key milestones and Go/No Go decision gates. The Contractor shall include BARDA Portfolio Management Milestones (See the AMCG Business Toolkit for a description and sample (http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) in their IMS and provide monthly updates within their IMS. This IMS shall include the following fields at a minimum; baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. The Contractor shall deliver the Integrated Master Schedule, viewed at the work package level in MS Project file format

 

  d.

Earned Value Contract Performance Report (EV-CPR)

 

  a.

The Offeror shall deliver an Earned Value Contract Performance Report (CPR) on a monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/). The Contractor shall provide Format 1, Format 3, and Format 5 only. Format 1 will be reported at the Work Breakdown Structure level agreed to by BARDA and the Contractor.

 

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  b.

EV Variance thresholds will be negotiated with the Contractor post-award but for planning purposes will likely be (+/- 10%). In conjunction with the CPR, the Contractor shall provide a monthly update to the IMS with up to date performance data and shall include actual start/finish and projected start / finish dates.

 

  c.

The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)), and actual costs of work performed (ACWP) as captured in the Contractor’s EVM systems.

 

  d.

The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the COR. Such meetings may include, but are not limited to, site visits to the Contractor’s and/or subcontractor’s facilities, meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and Government-contracted subject matter experts as required by the BARDA COR in order to facilitate review of contract activities.

 

  e.

The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency.

ARTICLE F.3. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work set forth in the Statement of Work dated September 29, 2015 set forth in SECTION J - List of Attachments of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule below:

 

Item

No.

  

Description

  

Addresses

  

Deliverable Schedule

1    Monthly Progress Report   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Reports are due on or before the 15th of each month following the end of each reporting period.
2    Annual Progress Report   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Reports are due on or before the 30th calendar day following the end of each reporting period.
3    Draft Final Progress Report   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Report is due 45 Calendar days prior to the expiration date of the contract.

 

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4    Final Progress Report   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Report is due no later than 30 calendar days after the expiration date of the contract.
5    FDA/ Regulatory Agency Correspondence and Meeting Summaries    COR: (1) electronic copy    Reports are due within 5 business days of each meeting for Contractor’s minutes, upon receipt of minutes from FDA/ regulatory agency, and upon request from the COR or Alternate COR.
6   

Integrated Master Project Plan -Critical Path Milestones

- Work Breakdown Structure

- Risk Mitigation Plan/Matrix

   COR: (1) electronic copy    Report is due within 90 days of contract award. Updates are due as requested by the COR or Alternate COR.
7    Technology Packages    COR: (1) electronic copy    Upon request from the COR or Alternate COR.
8    Experimental Protocols for non- clinical animal studies or clinical studies    COR: (1) electronic copy    Upon request from the COR or Alternate COR. Written approval from the COR or Alternate COR is required prior to the execution of the study.
9    Annual/Final Invention Report   

CO: (1) electronic copy

 

COR: (1) electronic copy

   An Annual Invention Report is due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report is due on or before the expiration date of the contract.
10    Publications    COR: (1) electronic copy    Reports are due within 10 business days for manuscripts and 5 business days for abstracts.
11    Press Releases    COR: (1) electronic copy    Reports/Notices are due for approval to the CO not less than five (5) business days prior to the issuance of any potential press release.

 

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12    Incident Security Report   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Reports are due within 24 hours after occurrence of an activity or incident.
13    Security Plan   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Alternate COR.
14    Quality Management System (QMS) Plan    COR: (1) electronic copy    Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Alternate COR.
15    Quality Agreement    COR: (1) electronic copy    Agreement is due at least 3 months prior to product procurement or as directed by the COR or Alternate COR.
16    VMI Plan   

CO: (1) electronic copy

 

COR: (1) electronic copy

   Plan is due upon completion of the Pre-EAU package.
17    Earned Value Management Requirements   

CO: (1) electronic copy

 

COR: (1) electronic copy

   As detailed in Section F.2 Reporting Requirements, subpart -F.

Email Addresses: CO - [**]

  COR - [**]

 

ARTICLE F.4.

FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address: http://www.acquisition.gov/far.

FAR 52.242-15, Stop Work Order (August 1989)

FAR 52.242-15, Alternate 1 (April 1984) is applicable to this contract.

 

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SECTION G - CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1.

CONTRACTING OFFICER

The following Contracting Officer (CO) will represent the Government for the purpose of this contract:

[**]

DHHS/OS/ASPR/AMCG

200 C St.

Washington, D.C. 20024

 

a.

The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, specifications or other requirements of this contract.

 

b.

The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

 

c.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, shall be considered grounds for deviation from this contract.

 

d.

The Government may unilaterally change its CO designation.

 

ARTICLE G.2.

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

[**]

Contracting Officer’s Representative

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Service

[**]

[**]

Mailing Address:

200 C St.

Washington, D.C. 20024

Alternate COR:

[**]

Alternate Contracting Officer’s Representative (COR)

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Service

[**]

[**]

Mailing Address:

330 Independence Avenue, SW

Washington, D.C. 20201

 

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The COR is responsible for:

 

  a.

Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

 

  b.

Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;

 

  c.

Performing technical evaluation as required;

 

  d.

Performing technical inspections and assisting the Contracting Officer in acceptances of deliverables required by this contract; and

 

  e.

Assisting in the resolution of technical problems encountered during performance.

 

  f.

The Government may unilaterally change its COR designation(s).

 

ARTICLE G.3.

KEY PERSONNEL

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individuals are considered to be essential to the work being performed hereunder:

 

Name

  

Title

[**]    [**]
[**]    [**]
[**]    [**]
[**]    [**]

 

ARTICLE G.4.

INVOICE SUBMISSION

 

  a.

The Contractor shall submit an electronic copy of contract monthly invoices/financial reports to the Contracting Officer as defined above, in ARTICLE G of this contract.

 

  b.

Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests made a part of the contract at Section J, Attachments 2 & 3.

 

  c.

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

 

  d.

The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any options for additional quantities (See estimated costs under Articles B.2 and B.3) and the reasons for the variance. Also refer to the requirements of FAR Clause 52.232-20, Limitation of Cost.

 

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  e.

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor’s name, contract number, and unique invoice number.

 

  f.

All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment.

 

ARTICLE G.5.

INDIRECT COST RATES

 

1.

The following interim provisional indirect rates will be utilized for billing purposes during the period of performance: Fringe benefits at [**], and Overhead (G&A) at [**]. Final rate proposals must be sent to the Contracting Officer, within 6 months of the fiscal year end. See FAR Clause 52.216-7, Allowable Cost and Payment.

 

ARTICLE G.6.

REIMBURSEMENT OF COST

 

1)

The Government shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:

 

  a)

All direct materials and supplies that are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders.

 

  b)

All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.

 

  c)

All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.

 

  d)

Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the following:

 

  i.

Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).

 

  ii.

Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.

 

  iii.

Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

 

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  iv.

Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.

 

ARTICLE G.7.

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) will be prepared Annually as to coincide with the Anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

2. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure website for review and comment at the following:

http://cpars.gov

 

ARTICLE G.8.

CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting the contract number HHSO100201500028C from Page 1 of the contract.

 

ARTICLE G.9.

GOVERNMENT PROPERTY

 

1.

In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated into this contract by reference. This document can be accessed at:

http://www.hhs.gov/hhsmanuals/ (HHS Logistics Management Manual)

Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

 

2.

Notwithstanding the provisions outlined in the HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated in this contract in paragraph 1. above, the Contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

 

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3.

Title will vest in the Government for equipment purchased as a direct cost.

SECTION H - Special Contract Requirements

 

ARTICLE H.1.

PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

 

a.

The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

 

b.

The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

 

c.

If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those Contractors with approved Human Subject Assurances.

 

ARTICLE H.2.

CLINICAL RESEARCH

These Clinical Terms apply to all contracts that involve clinical research.

The Government shall have unlimited rights to all protocols, data generated from the execution of these protocols, and final reports, funded by the Government under this contract, as defined in Rights in Data Clause in FAR 52.227-14. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form, to ensure the Government has the ability to review and distribute the deliverables, as the Government deems necessary.

H.2.1 Safety and Monitoring Issues

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

 

Page 29 of 50


If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number.

The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC.

To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following:

 

  1.

All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.

 

  2.

All changes in informed consent documents, identified by version number, date, or both and dates it is valid.

 

  3.

Termination or temporary suspension of patient accrual.

 

  4.

Termination or temporary suspension of the protocol.

 

  5.

Any change in IRB approval.

 

  6.

Any other problems or issues that could affect the participants in the studies.

Contractors must notify BARDA through the Contracting Officer’s Representative (COR) and Contracting Officer (CO) of any of the above changes within 24 hours from the time the Contractor becomes aware of the change by email, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC.

If a clinical protocol has been reviewed by an Institutional Bio-safety Committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

H.2.2. Data and Safety Monitoring Requirements

The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractors and Subcontractors as the Government deems necessary. The type of monitoring to be used shall be mutually agreed upon between the Contractor and the Government before enrollment starts. Discussions with the responsible BARDA COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following:

 

  1.

Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.

 

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  2.

Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.

 

  3.

Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB.

When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the Government before enrollment starts.

Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.

H.2.3. BARDA Protocol Review Process Before Patient Enrollment Begins

BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must provide the following (as applicable) for review and approval by the Government:

 

  1.

Clinical research protocol to be submitted for approval by the IRB identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria;

 

  2.

Informed consent document, identified by version number, date, or both and date it is valid;

 

  3.

Plans for the management of side effects;

 

  4.

Procedures for assessing and reporting adverse events;

 

  5.

Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory;

 

  6.

Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.

BARDA comments will be forwarded to the Contractor within two weeks (10 business days) of receipt of the above information. The Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by the BARDA COR to the satisfaction of the Government before patient accrual or participant enrollment can begin. After the Government receives the corrected documentation, a written protocol approval will be provided by the COR to the Contractor. This written approval provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by the Government.

Documentation of IRB approval, including OHRP FWA number, IRB registration number, and IRB and name, must be provided to the BARDA COR within 24 hours of receipt by the Contractor.

 

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H.2.4. Required Time-Sensitive Notification

Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible BARDA Contracting Officer’s representative (COR) as follows:

 

  1.

Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the BARDA program officer or the Contracting Officer’s Representative within 24 hours of FDA notification.

 

  2.

Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the BARDA Contracting Officer’s Representative within 24 hours of FDA notification.

 

  3.

IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the BARDA Contracting Officer’s Representative within 24 hours of FDA notification.

 

  4.

Expedited safety reports – shall be sent to the BARDA COR concurrently with the report to FDA.

 

  5.

Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the BARDA annually.

In case of problems or issues, the BARDA COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed.

Safety reporting for research not performed under an IND or IDE.

Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the BARDA Contracting Officer’s Representative and the Contractor.

 

ARTICLE H.3.

HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

 

ARTICLE H.4.

NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

 

ARTICLE H.5.

ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

 

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ARTICLE H.6.

RESTRICTIONS ON ABORTIONS

The Contractor shall not use funds for any abortion.

 

ARTICLE H.7.

CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with the March 4, 1997 Presidential Memorandum entitled “Prohibition on Federal Funding for Cloning of Human Beings”, federal funds may not be used for cloning of human beings.

 

ARTICLE H.8.

DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

 

ARTICLE H.9.

OMB CLEARANCE

In accordance with HHSAR 352.201-70, Paperwork Reduction Act of 1980 (44 U.S.C. section 3501), the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer’s Representative (COR) and the Contracting Officer has issued written approval to proceed.

 

ARTICLE H.10.

RESEARCH INVOLVING HUMAN FETAL TISSUE

All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.

The Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.

 

ARTICLE H.11.

REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

 

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Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

 

ARTICLE H.12.

PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

 

ARTICLE H.13.

RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

 

ARTICLE H.14.

CERTIFICATION OF FILING AND PAYMENT OF TAXES

The Contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

 

ARTICLE H.15.

ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE

 

  a.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

 

  b.

Accordingly, any Offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

 

  c.

The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

 

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In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, Offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows Offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, Offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

 

  d.

Respondents to this solicitation must identify any exception to Section 508 requirements. If a Offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

 

ARTICLE H.16.

FULL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-3 (October 2008) with ALTERNATE I (October 2008)

 

  a.

The Contractor shall use an Earned Value Management System (EVMS) that is compliant with the guidelines in ANSI/EIA Standard-748 (current version at the time of award) to manage this contract. If the Contractor’s current EVMS is not compliant at the time of award, see paragraph (b) of this clause. The Contractor shall submit EVM reports in accordance with the requirements of this contract.

 

  b.

If, at the time of award, the Contractor’s EVM system is not in compliance with the EVMS guidelines in ANSI/EIA Standard-748 (current version at time of award), the Contractor shall:

 

  a.

Apply the current system to the contract; and

 

  b.

Take necessary and timely actions to meet the milestones in the Contractor’s EVMS plan approved by the Contracting Officer.

 

  c.

HHS will not formally validate or accept the Contractor’s EVMS with respect to this contract. The use of the Contractor’s EVMS for this contract does not imply HHS acceptance of the Contractor’s EVMS for application to future contracts. The Contracting Officer or designee will conduct a Compliance Review to assess the Contractor’s compliance with its approved plan. If the Contractor does not follow the approved implementation schedule or correct all resulting system deficiencies noted during the Compliance Review within a reasonable time, the Contracting Officer may take remedial action that may include, but is not limited to, suspension of or reduction in progress payments, or a reduction in fee.

 

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  d.

HHS will conduct a Performance Measurement Baseline Review (PMBR). If a pre-award PMBR has not been conducted, a post-award PMBR will be conducted by HHS as early as practicable, but no later than ninety (90) days after contract award. The Contracting Officer may also require a PMBR as part of the exercise of an option or the incorporation of a major modification.

 

  e.

The Contractor shall provide access to all pertinent records and data requested by the Contracting Officer or a duly authorized representative as necessary to permit Government surveillance to ensure that the EVMS conforms, and continues to conform to the requirements referenced in paragraph (a) of this clause.

 

  f.

The Contractor shall require the subcontractors specified below to comply with the requirements of the clause:

 

ARTICLE H.17.

CONFIDENTIALITY OF INFORMATION

 

  a.

Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

 

  b.

The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the “Disputes” clause.

 

  c.

If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

 

  d.

Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

 

  e.

Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

 

  f.

Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

 

  g.

The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

 

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ARTICLE H.18.

INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR CONFLICTS OF INTERESTS

The Institution (includes any Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under BARDA contracts, or proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

As required by 45 CFR Part 94, the Institution shall, at a minimum:

 

  a.

Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator’s reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

 

  1.

With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;

 

  2.

With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest; or

 

  3.

Intellectual property rights and interests, upon receipt of income related to such rights and interest.

Significant financial interests do not include the following:

 

  1.

Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and

 

  2.

Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

 

  b.

Require each Investigator to complete training regarding the Institution’s financial conflicts of interest policy prior to engaging in research related to any BARDA funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.

 

  c.

Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the BARDA funded research.

 

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  d.

Require that each Investigator who is planning to participate in the BARDA funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interest (and those of the Investigator’s spouse and dependent children) no later than the date of submission of the Institution’s proposal for BARDA funded research. Require that each Investigator who is participating in the BARDA funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.

 

  e.

Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator’s significant financial interest is related to BARDA funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the BARDA funded research.

 

  f.

Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).

 

  g.

Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).

 

  h.

Maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures, and all actions under the Institution’s policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

 

  i.

Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.

 

  j.

Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors titled “Certification of Institutional Policy on Financial Conflicts of Interest”.

If the failure of an Institution to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the BARDA funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the BARDA funded research project.

 

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The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Institution’s review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of a financial conflict of interests. The Contracting Officer may require submission of the records or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer may decide that a particular financial conflict of interest will bias the objectivity of the BARDA funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

If the Contracting Officer determines that BARDA funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

 

ARTICLE H.19.

PUBLICATION AND PUBLICITY

The Contractor shall acknowledge the support of the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

“This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C”

Press Releases:

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money that: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by non-Governmental sources.

 

ARTICLE H.20.

ACCESS TO DOCUMENTATION/DATA

The Government shall have physical and electronic access to all documentation and data generated under this contract, including: all data documenting Contractor performance, all data generated, all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. Contractor shall provide the Government with an electronic copy of all correspondence with the FDA within 24 hours of receipt. The Government shall acquire unlimited rights to all data funded under a contract awarded in response to this RFP in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

 

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ARTICLE H.21.

DISSEMINATION OF INFORMATION

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

 

ARTICLE H.22.

DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

 

ARTICLE H.23.

IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data generated under this contract and determined by HHS to be relevant to this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

 

ARTICLE H.24.

CONFLICT OF INTEREST

The Contractor represents and warrants that, to the best of the Contractor’s knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR 2.101 and Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

 

ARTICLE H.25.

IN-PROCESS REVIEW

In Process Reviews (IPR) will be conducted at the discretion of the Government to discuss the progression of the milestones. The Government reserves the right to revise the milestones and budget pending the development of the project. Deliverables may be required when the IPRs are conducted. The Contractor’s success in completing the required tasks under each work segment must be demonstrated through the Deliverables and Milestones specified under SECTION F. Those deliverables will constitute the basis for the Government’s decision, at its sole discretion, to proceed with the work segment, or unilaterally institute changes to the work segment, or terminate the work segment.

 

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IPRs may be scheduled at the discretion of the Government to discuss progression of the contract. The Contractor shall provide a presentation following a prescribed template which will be provided by the Government at least 30 days prior to the IPR. The Contractor shall provide a draft presentation to the Contracting Officer at least 10 days prior to the IPR.

 

ARTICLE H.26.

PRIVACY ACT APPLICABILITY

 

1)

Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://www.gpoaccess.gov/cfr/index.html

 

2)

The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.

 

3)

The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm

 

ARTICLE H.27.

QA AUDIT REPORTS

BARDA reserves the right to participate in QA audits. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

 

   

Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications. The Contractor shall notify the CO and COR reasonably in advance of upcoming QA audit so that Government personnel may participate in person at BARDA’s discretion.

 

   

Contractor shall notify the COR and CO within 5 business days of report completion.

 

ARTICLE H.28.

BARDA AUDITS

Contractor shall accommodate periodic or ad hoc site visits by the Government. If the Government, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government.

 

   

If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.

 

   

COR and CO will review the report and provide a response to the Contractor with 10 business days.

 

   

Once corrective action is completed, the Contractor will provide a final report to the CO and COR.

 

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ARTICLE H.29.

SECURITY REPORTING REQUIREMENT

Violations of established security protocols shall be reported to the CO and COR upon discovery within 24 hours of its receipt of any compromise, intrusion, loss or interference of its security processes and procedures. The Contractor shall ensure that all software components that are not required for the operation and maintenance of the database/control system has been removed and/or disabled. The Contractor shall provide to the CO and the COR information appropriate to Information and Information Technology software and service updates and/or workarounds to mitigate all vulnerabilities associated with the data and shall maintain the required level of system security.

The Contractor will investigate violations to determine the cause, extent, loss or compromise of sensitive program information, and corrective actions taken to prevent future violations. The CO in coordination with BARDA will determine the severity of the violation. Any contractual actions resulting from the violation will be determined by the CO.

 

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PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/FAR/ HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html

General Clauses for Cost-Reimbursement/Fixed Price Research and Development Contract

(1) FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

Reg

  

Clause

  

Date

  

Clause Title

FAR    52.202-1    Nov 2013    Definitions
FAR    52.203-3    Apr 1984    Gratuities
FAR    52.203-5    May 2014    Covenant Against Contingent Fees
FAR    52.203-6    Sep 2006    Restrictions on Subcontractor Sales to the Government
FAR    52.203-7    May 2014    Anti-Kickback Procedures
FAR    52.203-8    May 2014    Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
FAR    52.203-10    May 2014    Price or Fee Adjustment for Illegal or Improper Activity
FAR    52.203-12    Oct 2010    Limitation on Payments to Influence Certain Federal Transactions
FAR    52.203-13    Apr 2010    Contractor Code of Business Ethics and Conduct
FAR    52.203-14    Dec 2007    Display of Hotline Poster(s)
FAR    52.203-17    Apr 2014    Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights
FAR    52.204-4    May 2011    Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
FAR    52.204-7    Jul 2013    System for Award Management
FAR    52.204-10    Jul 2013    Reporting Executive Compensation and First-Tier Subcontract Awards
FAR    52.204-13    Jul 2013    System for Award Management Maintenance
FAR    52.209-6    Aug 2013    Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
FAR    52.209-10    Dec 2014    Prohibition on Contracting with Inverted Domestic Corporations
FAR    52.210-1    Apr 2011    Market Research
FAR    52.215-2    Oct 2010    Audit and Records – Negotiation
FAR    52.215-8    Oct 1997    Order of Precedence - Uniform Contract Format
FAR    52.215-10    Aug 2011    Price Reduction for Defective Cost or Pricing Data
FAR    52.215-11    Aug 2011    Price Reduction for Defective Certified Cost or Pricing Data—Modifications.
FAR    52.215-12    Oct 2010    Subcontractor Certified Cost or Pricing Data
FAR    52.215-13    Oct 2010    Subcontractor Certified Cost or Pricing Data—Modifications
FAR    52.215-15    Oct 2010    Pension Adjustments and Asset Reversions
FAR    52.215-18    Jul 2005    Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions
FAR    52.215-19    Oct 1997    Notification of Ownership Changes
FAR    52.215-21    Oct 2010    Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -Modifications
FAR    52.215-23    Oct 2009    Limitations on Pass-Through Charges
FAR    52.216-7    Jun 2013    Allowable Cost and Payment
FAR    52.216-8    Jun 2011    Fixed Fee
FAR    52.219-8    Oct 2014    Utilization of Small Business Concerns
FAR    52.219-28    July 2013    Post-Award Small Business Program Representation

 

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FAR    52.222-1    Feb 1997    Notice to the Government of Labor Disputes
FAR    52.222-2    Jul 1990    Payment for Overtime Premiums
FAR    52.222-3    Jun 2003    Convict Labor
FAR    52.222-21    Apr 2015    Prohibition of Segregated Facilities
FAR    52.222-26    Apr 2015    Equal Opportunity
FAR    52.222-35    Jul 2014    Equal Opportunity for Veterans
FAR    52.222-36    Jul 2014    Equal Opportunity for Workers with Disabilities
FAR    52.222-37    Jul 2014    Employment Reports on Veterans
FAR    52.222-40    Dec 2010    Notification of Employee Rights Under the National Labor Relations Act
FAR    52.222-43    May 2014    Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts)
FAR    52.222-50    Mar 2015    Combating Trafficking in Persons
FAR    52.222-54    Aug 2013    Employment Eligibility Verification
FAR    52.223-6    May 2001    Drug-Free Workplace
FAR    52.223-18    Aug 2011    Encouraging Contractor Policy to Ban Text Messaging While Driving
FAR    52.224-1    April 1984    Privacy Act Notification
FAR    52.224-2    April 1984    Privacy Act
FAR    52.225-13    Jun 2008    Restrictions on Certain Foreign Purchases
FAR    52.227-1    Dec 2007    Authorization and Consent, Alternate 1 (APR 1984)
FAR    52.227-2    Dec 2007    Notice and Assistance Regarding Patent and Copyright Infringement
FAR    52.227-3    Apr 1984    Patent Indemnity
FAR    52.227-11    May 2014    Patent Rights – Ownership by the Contractor
FAR    52.227-14    May 2014    Rights in Data – General
FAR    52.228-7    Mar 1996    Insurance – Liability to Third Persons
FAR    52.229-3    Feb 2013    Federal, State and Local Taxes
FAR    52.230-2    May 2014    Cost Accounting Standards
FAR    52.230-6    June 2010    Administration of Cost Accounting Standards
FAR    52.232-1    Apr 1984    Payments
FAR    52.232-2    Apr 1984    Payments under Fixed-Price Research and Development Contracts
FAR    52.232-8    Feb 2002    Discounts for Prompt Payment
FAR    52.232-9    Apr 1984    Limitation on Withholding of Payments
FAR    52.232-11    Apr 1984    Extras
FAR    52.232-17    May 2014    Interest
FAR    52.232-20    Apr 1984    Limitation of Cost
FAR    52.232-23    May 2014    Assignment of Claims
FAR    52.232-25    Jul 2013    Prompt Payment
FAR    52.232-33    Jul 2013    Payment by Electronic Funds Transfer—System for Award Management
FAR    52.233-1    May 2014    Disputes
FAR    52.233-3    Aug 1996    Protest After Award, Alternate I
FAR    52.233-4    Oct 2004    Applicable Law for Breach of Contract Claim
FAR    52.242-1    Apr 1984    Notice of Intent to Disallow Costs
FAR    52.242-3    May 2014    Penalties for Unallowable Costs
FAR    52.242-4    Jan 1997    Certification of Final Indirect Costs
FAR    52.242-13    Jul 1995    Bankruptcy
FAR    52.242-15    Aug 1989    Stop Work Order, Alternate I (Aug 1984)
FAR    52.243-1    Aug 1987    Changes—Fixed-Price Alternate V (Apr 1984).
FAR    52.243-2    Aug 1987    Changes—Cost-Reimbursement Alternate V (Apr 1984).
FAR    52.243-7    Apr 1984    Notification of Changes
FAR    52.244-2    Oct 2010    Subcontracts, Alternate 1 (Jun 2007)
FAR    52.244-5    Dec 1996    Competition in Subcontracting
FAR    52.244-6    Apr 2015    Subcontracts for Commercial Items
FAR    52.245-1    Apr 2012    Government Property
FAR    52.245-9    Apr 2012    Use and Charges

 

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FAR    52.246-23    Feb 1997    Limitation of Liability.
FAR    52.246-25    Feb 1997    Limitation of Liability—Services
FAR    52.248-1    October 2010    Value Engineering
FAR    52.249-2    Apr 2012    Termination for the Convenience of the Government (Fixed-Price)
FAR    52.249-6    May 2004    Termination (Cost-Reimbursement)
FAR    52.249-8    Apr 1984    Default (Fixed-Price Supply and Service)
FAR    52.249-9    Apr 1984    Default (Fixed-Price Research and Development)
FAR    52.249-14    Apr 1984    Excusable Delays
FAR    52.253-1    Jan 1991    Computer Generated Forms

 

(2)

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

HHSAR    352.202-1    Jan 2006    Definitions - with Alternate paragraph (h)
HHSAR    352.203-70    Mar 2012    Anti-Lobbying
HHSAR    352.216-70    Jan 2006    Additional Cost Principles
HHSAR    352.222-70    Jan 2010    Contractor Cooperation in Equal Employment Opportunity Investigations
HHSAR    352.223-70    Sept 2010    Safety and Health
HHSAR    352.227-70    Jan 2006    Publications and Publicity
HHSAR    352.228-7    Dec 1991    Insurance - Liability to Third Persons
HHSAR    352.231-70    Jan 2006    Salary Rate Limitation
HHSAR    352.231-71    Jan 2001    Pricing of Adjustments
HHSAR    352.233-71    Jan 2006    Litigation and Claims
HHSAR    352.242-70    Jan 2006    Key Personnel
HHSAR    352.242-73    Jan 2006    Withholding of Contract Payments
HHSAR    352.242-74    Apr 1984    Final Decisions on Audit Findings

 

ARTICLE I.2.

ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

 

a.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

  1.

FAR 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

 

  2.

FAR 52.227-16, Additional Data Requirements (June 1987).

 

ARTICLE I.3.

ADDITIONAL HHSAR CLAUSES – IN FULL TEXT

352.231-70 Salary rate limitation (August 2012)

 

  1.

Pursuant to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date an expense is incurred.

 

  2.

For purposes of the salary rate limitation, the terms “direct salary,” “salary”, and “institutional base salary”, have the same meaning and are collectively referred to as “direct salary”, in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).

 

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Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds.

 

  1.

The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.

 

  2.

See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods.

 

ARTICLE I.4.

ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT

FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

 

a.

The Government may extend the term of this contract by written notice to the Contractor within 30 Days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

 

b.

If the Government exercises this option, the extended contract shall be considered to include this option clause.

 

c.

The total duration of this contract, including the exercise of any options under this clause, shall not exceed 8 years.

FAR 52.219-1 Small Business Program Representations (Oct 2014)

 

  1.

The North American Industry Classification System (NAICS) code for this acquisition is 541711.

 

  2.

The small business size standard is 500 employees.

 

  3.

The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

 

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b.

Representations.

 

  1.

The Offeror represents as part of its offer that it [X] is, [    ] is not a small business concern.

 

  2.

Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents, for general statistical purposes, that it [    ] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.

 

  3.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents as part of its offer that it [    ] is, [X] is not a women-owned small business concern.

 

  4.

Women-owned small business (WOSB) concern eligible under the WOSB Program. [Complete only if the Offeror represented itself as a women-owned small business concern in paragraph (b)(3) of this provision.] The Offeror represents as part of its offer that—

 

  (i)

It [    ] is, [X] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

 

  (ii)

It [    ] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(4)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture:             .] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

 

  5.

Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a women-owned small business concern eligible under the WOSB Program in (b)(4) of this provision.] The Offeror represents as part of its offer that—

 

  (i)

It [    ] is, [X] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

 

  (ii)

It [    ] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(5)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The Offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture:             .] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

 

  6.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents as part of its offer that it [    ] is, [X] is not a veteran-owned small business concern.

 

  7.

[Complete only if the Offeror represented itself as a veteran-owned small business concern in paragraph (b)(6) of this provision.] The Offeror represents as part of its offer that is [    ] is, [    ] is not a service-disabled veteran-owned small business concern.

 

  8.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents, as part of its offer, that –

 

Page 47 of 50


  (i)

It [    ] is, [X] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and

 

  (ii)

It [    ] is, [X] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (b)(8)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture:             .] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

 

c.

Definitions. As used in this provision—

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business concern eligible under the WOSB Program. “Service-disabled veteran-owned small business concern”—

 

  1.

Means a small business concern—

 

  (i)

Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

 

  (ii)

The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

 

  2.

Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern,” means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and the size standard in paragraph (a) of this provision.

“Veteran-owned small business concern” means a small business concern—

 

  1.

Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

 

  2.

The management and daily business operations of which are controlled by one or more veterans.

“Women-owned small business concern,” means a small business concern –

 

Page 48 of 50


  1.

That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

 

  2.

Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

 

d.

Notice.

 

  1.

If this solicitation is for supplies and has been set aside, in whole or in part, for small business concerns, then the clause in this solicitation providing notice of the set-aside contains restrictions on the source of the end items to be furnished.

 

  2.

Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a business concern that is small, HUBZone small, small disadvantaged, service-disabled veteran-owned small, economically disadvantaged women-owned small, or women-owned small eligible under the WOSB Program in order to obtain a contract to be awarded under the preference programs established pursuant to section 8, 9, 15, 31, and 36 of the Small Business Act or any other provision of Federal law that specifically references section 8(d) for a definition of program eligibility, shall –

 

  (i)

Be punished by imposition of fine, imprisonment, or both;

 

  (ii)

Be subject to administrative remedies, including suspension and debarment; and

 

  (iii)

Be ineligible for participation in programs conducted under the authority of the Act.

FAR 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)

 

a.

Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

 

b.

The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

 

c.

Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

 

Page 49 of 50


PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

 

  1.

Statement of Work, dated September 29, 2015, 18 pages

 

  2.

Invoice/Financing Instructions for Cost-Reimbursement Type Contracts

 

  3.

Invoice Instructions for Fixed-Priced Type Contracts

 

  4.

Sample Invoice Form

 

  5.

Research Patient Care Costs

 

  6.

Report of Government Owned, Contractor Held Property, 1 page.

 

  7.

Form SF-LLL, Disclosure of Lobbying Activities, 2 pages

 

  8.

Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page

 

Page 50 of 50


Attachment 1 - Statement of Work (SOW)

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to support this acquisition.

Avita Medical BASE SOW

Summary Table

 

CLIN

  

WBS 1st
Level
Element

  

Title

  

Objectives

0001    1    Project Management   

•  Establish project management infrastructure

 

•  Establish EVM systems

 

•  Finalize IMPP

 

•  Technical and financial reporting

   2    Non-Clinical Objectives   

•  Close gaps in non-clinical data required for PMA module 1 of 3, including biocompatibility, human factors, packaging testing to generate ISO design dossier as an FDA-compliant design history file.

 

•  Establish appropriate training for use of ReCell in mass casualty setting.

 

•  Achieve 4-year stability

   3    Clinical Objectives   

•  Complete pivotal trials (-5 and -6 protocols) and clinical study reports for PMA module 3 of 3.

   4    Regulatory Objectives   

•  Fulfill Pre-EUA requirements

 

•  Modular PMA Submission

 

•  Secure Pre-Market Approval (PMA)

   5    Product Development for Mass Casualty/VMI   

•  Gather requirements for Mass Casualty and VMI

 

•  Redesign ReCell packaging and any other subcomponents in order to meet requirements for more efficient VMI and deployment

 

•  Complete V&V

   6    QSR Objectives   

•  Perform QSR Gap remediation (address all gaps identified) for PMA module 2 of 3.

 

•  Scale up manufacturing process for ReCell to support USG acquisition and US Market introduction

 

•  Qualify alternate suppliers, for sustainability

0002    7    Procurement (Initial)   

•  Execute acquisition contract

 

•  Establish VMI

 

•  Manage inventory

Overview

Avita’s initial primary objective with the proposed effort is to secure FDA approval for the ReCell device. In order to accomplish this we need (1) a documented design (with documentation and supporting testing -e.g. biocompatibility- done to FDA standards rather than ISO standards), for which the work is done in WBS 2.1.2, 2.1.3, and 2.1.4; (2) an FDA-compliant quality system and documentation of GMP manufacturing: WBS 6.1; and (3) Pivotal Clinical Data: WBS 3.1.

The above-mentioned work is delivered to FDA via PMA modules 1, 2 and 3, respectively (WBS 4.2.2). The PMA modules will require organizing and assembling reports into a standardized format, setting context and drawing overall conclusions. In addition to submission of the PMA modules, Avita will also draft (and get FDA-approval of) a Conditions of Approval study protocol (WBS 3.3.1.1, 4.2.2.4.2), and pass through a panel (of experts) review (WBS 4.2.2.5). Avita will need favorable reviews of the PMA modules, CoA protocol approval, and panel review to get the product approved.

 

Page 1 of 18


Concurrent with the FDA approval process, there is an Emergency Use pathway, activated in the event of a mass casualty, which would enable FDA to authorize use of an investigational (unapproved) product for life-saving measures. There is “pre-emergency” work that can be done to facilitate a future potential Authorization. (WBS 4.1)

Once there is confidence in EUA status or there is PMA approval, base procurement (WBS 7.1.1) is triggered.

There are several other items that are part of the program in order to ensure success in stockpiling, distributing, and using ReCell during an emergency event:

 

  1.

Training of medics for use of ReCell in mass casualty events (WBS 2.1.1).

 

  2.

Increased shelf-life, with a target of up to 4 years (as supported by stability testing) (WBS 2.3)

 

  3.

VMI planning/implementation (WBS 7.2, 7.3, 7.4)

 

  4.

Optimize product packaging more for palletized storage and VMI, (WBS 5)

 

  5.

Qualifying second sources for key components and for product final assembly (i.e. alternative/supplementary sources for enzyme and a supplement/alternative to Parker) (WBS 6.2.2).

CLIN 0001 - Base Period

 

1.0

Program Management

 

  1.1

Internal Project Management

 

WBS# and Title

  

Milestone

  

Deliverable

1.1.5 Integrated Master Project Plan    Upon delivery to and acceptance by BARDA    All required elements of this plan as listed in the RFP

 

  1.1.5

Title: Integrated Master Project Plan

Objective/Description of Work: Avita will compile all necessary materials and finalize all aspects of the project related to preparing the Integrated Master Project Plan. This will include finalizing critical path milestones, Work Breakdown Structure (WBS), and Risk Mitigation Plan. The final deliverable of the IMPP will represent the finalization and approval of all project elements between Avita and BARDA.

Milestones:

 

  1.1.5.1

Critical Path Milestones – The critical path milestones are finalized and submitted, reviewed, and approved by BARDA.

 

  1.1.5.2

Work Breakdown Structure – The WBS is finalized and submitted, reviewed, and approved by BARDA for all project activities.

 

  1.1.5.3

Risk Mitigation Plan/Matrix – Any additional elements of risk are identified and all elements of risk are finalized and submitted, reviewed, and approved by BARDA. Risk management plans for each risk are finalized and submitted, reviewed, and approved by BARDA.

 

Page 2 of 18


Deliverables:

 

  1.1.5

Integrated Master Project Plan – Containing all required elements as listed in the RFP and/or requested by BARDA.

 

  1.1.5.1

Critical Path Milestones – An updated and finalized critical path milestone document.

 

  1.1.5.2

Work Breakdown Schedule – An updated and finalized WBS document.

 

  1.1.5.3

Risk Mitigation Plan/Matrix – An updated and finalized risk mitigation plan/matrix.

 

  1.2

Contract Management

 

WBS# and Title

  

Milestone

  

Deliverable

1.2.2 Reporting    Upon delivery to and acceptance by BARDA   

All required reports as

listed in the RFP and

requested by BARDA

1.2.3 Meetings    BARDA Kick-Off Meeting    Meeting Presentation Materials

 

  1.2.2

Title: Reporting

Objective/Description of Work: Avita will comply with all reporting requirements as outlined and formatted in the RFP and as requested by BARDA. Reporting will include at a minimum monthly progress reports, annual progress reports, annual invention reports, draft final report, and final report. Additional deliverables such as technology packages, experimental protocols, publication, press releases, security reports, or other reports will be provided to BARDA for review prior to initiation of a corresponding work element, deliverable, or FDA submission.

Milestones:

 

  1.2.2.1

Monthly Progress Report – Delivery to and acceptance by BARDA.

 

  1.2.2.2

Annual Progress Report – Delivery to and acceptance by BARDA.

 

  1.2.2.3

Invention Reports – Delivery to and acceptance by BARDA.

 

  1.2.2.4

Draft Final and Final Progress Reports – Delivery to and acceptance by BARDA.

Deliverables:

 

  1.2.2.1

Monthly Progress Report – A report detailing the prior month’s activities and activities planned for the following month. Report will be delivered prior to the 15th of the month following the reporting period.

 

  1.2.2.2

Annual Progress Report – A report summarizing the activities of the period of performance and the activities planned for the upcoming period. Report will be delivered prior to the 30th of the month following the reporting period.

 

  1.2.2.3

Annual/Final Invention Report – A report detailing any intellectual property developed as a result of the work performed during each period of performance and the entire contract period. Report will be delivered in conjunction with the annual progress report.

 

Page 3 of 18


  1.2.2.4

Draft Final and Final Progress Report – The Final Progress Report will include a complete summary of all work performed during the entire contract period of performance. A Draft Final Progress Report will be delivered 45 days prior to contract expiration for BARDA review and comments. A Final Progress Report will be delivered prior to 30 days following contract expiration.

 

  1.2.3

Title: Meetings

Objective/Description of Work: Avita and BARDA will engage in regular meetings to coordinate and review project activities. Meetings will be both face-to-face and teleconference/video conference. The first official meeting will be the face-to-face kick-off meeting, followed by status update meetings on a biweekly/monthly basis, ad hoc teleconferences and site visits, and annual meetings to report on the period of performance activities.

Milestones:

1.2.3.1 Kickoff Meeting with BARDA – The contract is awarded and a face-to face kickoff meeting is conducted within 30 days of award date.

Deliverables:

1.2.3.2 Kickoff Meeting Presentation Materials – Avita will prepare all necessary presentation materials for the kickoff meeting.

 

  1.4

IMS and EVM

 

WBS# and Title

  

Milestone

  

Deliverable

1.4.2 Performance Measurement Baseline    Performance Measurement Baseline Review (PMBR)    All required components for the PMBR
1.4.3 Integrated Master Schedule    PMBR    Integrated Master Schedule
1.4.4 Monthly Earned Value Performance Report    Delivery to and acceptance by BARDA    Monthly Earned Value Performance Report
1.4.5 Supplemental monthly CAP report    Delivery to and acceptance by BARDA    Supplemental monthly CAP report

 

  1.4.2

Title: Performance Measurement Baseline

Objective/Description of Work: The Performance Measurement Baseline will provide a master schedule of deliverables, costs, and milestones in order to completely cover all items in the SOW. All required components will be submitted to BARDA within 90 days of contract award. BARDA and Avita will mutually agree on the budget, schedule and technical plan baselines as a result of the PMBR.

Milestones:

 

  1.4.2

Performance Measurement Baseline Review – The PMBR plan is submitted and reviewed by BARDA.

 

Page 4 of 18


Deliverables:

 

  1.4.2

Performance Measurement Baseline Review Plan and Required Components – A plan detailing a schedule of deliverables, costs, milestones, and risks that will serve as the basis for measuring project progress.

 

  1.4.3

Title: Integrated Master Schedule (IMS)

Objective/Description of Work: The IMS will be used to monitor performance of the contract. Avita will develop an IMS in a format approved by BARDA in order to track key milestones, Go/No Go decision gates. The IMS will contain baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. Avita will provide a baseline IMS for the PMBR and monthly updates thereafter.

Milestones:

 

  1.4.2

Integrated Master Schedule is approved by BARDA.

Deliverables:

1.4.3 Integrated Master Schedule – Provided for the PMBR and monthly in order to monitor performance of the contract. The IMS shall be provided at the work package level in MS Project file format.

 

  1.4.4

Title: Monthly Earned Value Performance Report

Objective/Description of Work: The Monthly Earned Value Performance Report will be generated from Avita’s EVMS in order to track any project variances against the baseline. The report will contain technical, schedule, and cost status information in order to identify any issues that may impact project progress and/or cost.

Milestones:

 

  1.4.4

Monthly Earned Value Performance Report – Delivery to and acceptance by BARDA.

Deliverables:

 

  1.4.4

Monthly Earned Value Performance Report – Provided monthly to track project progress according to WBS and EV variance.

 

  1.4.5

Title: Supplemental Monthly CAP Report

Objective/Description of Work: The Supplemental Monthly CAP Report will be generated from Avita’s EVMS and will contain cost information to report on the time phased budget, earned value, and actual costs of work performed. The report will be submitted monthly to BARDA for review.

Milestones:

 

  1.4.5

Supplemental Monthly CAP Report – Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.4.5

Supplemental Monthly CAP Report – Provided monthly to detail time phased budget, earned value, and actual costs of work performed as captured by Avita’s EVM systems.

 

Page 5 of 18


2

Non-Clinical Objectives

 

  2.1

Efficacy and Safety

 

WBS# and Title

  

Milestone

  

Deliverable

2.1.1.1 Updated training resources for mass casualty    Effective training for mass casualty event.    Updated user training documentation
2.1.2 Biocompatibility review    Biocompatibility review complete    Biocompatibility Review Report
2.1.3 Human Factors    FDA requests human factors studies    Human factors studies submitted to FDA
2.1.4 FDA-compliant design documentation    Completion of backup documentation for PMA module 1.    QSR-mandated design control documents and supporting lab test results

 

  2.1.1.1

Title: Updated training resources for mass casualty

Objective/Description of Work: Existing training manuals for use of the ReCell device are designed for a clinical/surgical setting by experienced clinicians. Led by the Director of Education, with support from the Education Specialist, Avita will develop a new training protocol sufficient for a mass casualty event for ReCell to be used by minimally trained personnel that may or may not have burn surgery experience. Target goal will be a one-hour training session to personnel at a trained medic level or higher. New training materials will be submitted to BARDA for review/feedback and then finalized.

Milestones:

2.1.1 Creation of training materials, including video, workshop/online course materials, reference guides, as determined in collaboration with BARDA

Deliverables:

2.1.1.1 Training materials as determined in collaboration with BARDA.

 

  2.1.2

Title: Biocompatibility review complete

Objective/Description of Work: Full biocompatibility is demonstrated for EU and Australia, to ISO standards. The testing work needs to be done to US FDA standards. Results of biocompatibility review will be submitted to BARDA for review/feedback.

Milestones:

2.1.2 Biocompatibility submitted to FDA

Deliverables:

2.1.2 Biocompatibility Review Report draft and final report submitted to BARDA and final report submitted to FDA

 

  2.1.3

Title: Human Factors

Objective/Description of Work: Avita will conduct an evaluation to ensure that the ReCell devices meet usability guidelines when used by the intended user population. Avita will conduct all required studies and submit the results to BARDA for review and feedback. Upon BARDA approval, Avita will submit report to FDA.

 

Page 6 of 18


Milestones:

2.1.3 Requested data/report submitted to FDA

Deliverables:

2.1.3 As requested by FDA, human factors draft and final reports submitted to BARDA and final data and report submitted to FDA

 

  2.1.4

Title: FDA-Compliant Design Documentation

Objective/Description of Work: Avita’s recent gap analysis for PMA module 1 readiness indicates that in addition to biocompatibility testing Avita will need to create an FDA QSR-compliant design control document package, including backup lab test data and reports, including packaging testing. Avita will provide the various reports to BARDA, as requested, for review and approval prior to sending to FDA.

Milestones:

 

  2.1.4.1

Functional Testing Complete

 

  2.1.4.2

Packaging/Shipping Testing Complete

 

  2.1.4.3

EMI/EMC Testing Complete

 

  2.2

Non-clinical data sufficient for PMA module 1 of 1

Deliverables:

 

  2.1.4

QSR-mandated design control documents and supporting lab test results – Avita will generate a design control document package that will meet current FDA requirements, in support of PMA module 1 of 1

 

  2.3

Stability and Review of Extended Shelf Life

 

WBS# and Title

  

Milestone

  

Deliverable

2.3.1 Stability Plan    Expiration limiting components identified and plan developed to extend to 4-year target    Stability Plan
2.3.6 Stability Report (accelerated aging)    Accelerated aging testing results complete    Stability report
2.3.7 Stability report (real- time aging)    Real-time aging testing results complete    Stability report
2.3.8 Review of extended shelf life    New expiry limits determined    Results report submitted to BARDA
2.3.9 Revisions to labeling    Stability extension submission    Shelf life report and revised labeling submitted to FDA

 

  2.3.1

Title: S0tability Plan

Objective/Description of Work: Avita will develop a stability plan that will outline the testing necessary to extend the shelf life of the ReCell unit to 4 years in order to minimize product losses due to expiry. Avita will focus on specific expiration-limiting components (enzyme and buffer, RPU, and nozzle). Avita will design and execute on a stability testing plan to verify stability for extension of shelf life. Reports will be submitted to BARDA detailing the shelf life of ReCell units. Labeling will be modified based on new expiries and submitted to FDA to approval.

 

Page 7 of 18


Milestones:

 

  2.3.1

Expiration limiting components are identified and a plan is developed to extend ReCell unit to a target of 4-year expiry.

Deliverables:

 

  2.3.1

Stability plan outlining all necessary real-time and accelerated aging testing required to justify expiry.

 

  2.3.6

Title: Stability Report (accelerated aging)

 

  2.3.7

Objective/Description of Work: Following accelerated aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.6

Stability testing results complete.

Deliverables:

 

  2.3.6

Stability report detailing product performance for ReCell components after aging

 

  2.3.7

Title: Stability Report (real-time aging)

Objective/Description of Work: Following real-time aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.7

Stability testing results complete.

Deliverables:

 

  2.3.7

Stability report detailing aged performance for ReCell components

 

  2.3.8

Title: Review of extended shelf life

Objective/Description of Work: Avita will prepare a report for BARDA detailing the changes product shelf life. Avita will report on the plan for accordingly revised product labeling to be submitted to FDA.

Milestones:

 

  2.3.8

Delivery of report of extended shelf life

Deliverables:

 

  2.3.8

Shelf life report delivered to BARDA for review, followed by a report detailing plans for FDA submission, and implications for the VMI.

 

  2.3.9

Title: Revisions to labeling

 

Page 8 of 18


Objective/Description of Work: Avita will revised the product labeling to reflect new shelf life parameters, and will submit to FDA.

Milestones:

 

  2.3.9

FDA approval of revised product labeling

Deliverables:

 

  2.3.9

New product labeling and FDA submission for review/approval of new product labeling.

 

3

Clinical

 

  3.1

Pivotal Clinical Trials

 

WBS# and Title

  

Milestone

  

Deliverable

3.1.1.4 Clinical Study Report    CTP001-5 Clinical Study Report (CSR), review complete    CTP001-5 Clinical Study Report (CSR), review/submit to FDA
3.1.2.6.1 Statistical Analysis (9mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.2 Clinical Study Report (9mo)    CTP001-6 Initial (9-months) CSR complete    CTP001-6 Initial (9-months) CSR, review (PMA module 3 of 3)
3.1.2.6.4 Statistical Analysis (12mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.5 Clinical Study Report (12mo)    CTP001-6 Final (12-months) CSR complete    CTP001-6 Final (12-months) CSR, review

 

  3.1.2.8

Title: Final CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pivotal Clinical Trials encompass two ongoing clinical protocols: CTP001-5 (deep partial-thickness) and CTP001-6 (mixed depth including full-thickness). Both studies show definitive closure using less donor skin with ReCell as compared to standard care, and are also looking at long-term scar outcomes. The clinical study report (CSR) from CTP001-6 is the primary component of PMA module 3 of 3. All CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.1.1.1

Last subject last visit for CTP001-5 (complete)

 

  3.1.1.4

Clinical Study Report complete for CTP001-5

 

  3.1.2.1.1

FDA Statistical Analysis Plan submitted and approved by FDA for CTP001-6 (complete)

 

  3.1.2.3.2

Last subject last visit for CTP001-6

 

  3.1.2.6.4

CRO completes 9-month statistical analysis for PMA module 3 of 3.

 

  3.1.2.8

Final CSR review complete and data is determined to be sufficient for FDA submission

 

Page 9 of 18


Deliverables:

3.1.1.4 CTP001-5 Clinical Study Report (CSR)

 

  3.1.2.6.1

CTP001-6 9-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.2

CTP001-6 Initial (9-months) CSR (for PMA module 3 of 3)

 

  3.1.2.6.4

CTP001-6 12-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.5

CTP001-6 Final (12-months) CSR

 

4

Regulatory

 

  4.1

Pre-Emergency Use Authorization

 

WBS# and Title

  

Milestone

  

Deliverable

4.1 Pre-Emergency Use Authorization    Avita completes all submissions needed for EUA    All data requested by BARDA to obtain pre-EUA

 

  4.1

Title: Pre-Emergency Use Authorization

Objective/Description of Work: Avita will support BARDA/HHS in obtaining a Pre-Emergency Use Authorization for the ReCell device. All required studies, reviews, reports, and analyses will be provided as requested.

Milestones:

 

  4.1

Avita completes all submissions needed for EUA

Deliverables:

 

  4.1

Submission to BARDA/HHS of all required materials needed for Pre-EUA.

 

  4.2

Premarket Approval (PMA

 

WBS# and Title

  

Milestone

  

Deliverable

4.2.2.1.4 Module 1 Submission    Module 1 package assembled    Module 1 package to FDA
4.2.2.2.4 Module 2 Submission    Module 2 package assembled    Module 2 package to FDA
4.2.2.3.4 Module 3 Submission    Module 3 package assembled    Module 3 package to FDA

4.2.2.5.3 Create action plan to address panel recommendations

   FDA Panel Meeting    Action Plan

 

  4.2.2.1.4

Title: Module 1 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package with modular submissions for FDA review and approval. The PMA package will consist of three PMA modules. Module 1 will focus on non-clinical data.

Milestones:

 

  4.2.2.1.4

Module 1 package assembled

 

Page 10 of 18


Deliverables:

 

  4.2.2.1.4

Module 1 submission to FDA – Module 1 includes biocompatibility, human factors, shipping/packaging validation, EMI/EMC, and all other required non-clinical data.

 

  4.2.2.2.4

Title: Module 2 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 2 will focus on manufacturing data.

Milestones:

 

  4.2.2.2.4

Module 2 package assembled

Deliverables:

 

  4.2.2.2.4

Module 2 submission to FDA – Submission will include the principles of operation, quality system and manufacturing documentation, sterilization, shelf-life information, and packaging information.

 

  4.2.2.3.4

Title: Module 3 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 3 will focus on clinical data. Module 3 will be submitted to BARDA for review and approval, followed by submission to FDA.

Milestone:

 

  4.2.2.3.4

Module 3 package assembled and approved by BARDA

Deliverables:

 

  4.2.2.3.4

Module 3 submission to FDA – Submission will include the CTP001-6 clinical data labels and manuals, draft post-marketing plan (CoA study protocol) and bibliography.

 

5

Product Development for mass casualty/VMI

 

  5.1

Requirement Gathering, 5.2 Product Design, 5.3 Systems Requirements and Design Review, and 5.4 CDC Quality Agreement

 

WBS# and Title

  

Milestone

  

Deliverable

5.3 Systems Requirements (VMI optimization) and Design Review

   Review of VMI optimized product design package complete    Product optimized for VMI Design Package

5.4 CDC Quality Agreement

   Executed CDC Quality Agreement    CDC Quality Agreement

5.3, 5.4 Title: Systems Requirements (VMI optimization) and Design Review

Objective/Description of Work: In order to develop a product ready for manufacturing and stockpiling, Avita will work with BARDA to first gather the requirements for DFM/DFA, inventory management and any other requirements. Based on the requirements, Avita will initiate Product Design to all ensure the product will meet specifications. This includes design and review for any changed or affected part: Components, Subassembly, Product System, and Packaging Design. Document package will be sent to BARDA for review. Avita will work with CDC to establish a quality agreement, if required.

 

Page 11 of 18


Milestones:

 

  5.1

Requirements document compiled from BARDA

 

  5.2.1.2

Component Design Review complete

 

  5.2.2.2

Subassembly Design Review complete

 

  5.2.3.2

Product System Design Review complete

 

  5.2.4.2

Packaging Design Review complete

 

  5.3

Full systems requirements and design review complete and approved by BARDA

 

  5.4

If required, establish quality agreement with CDC for supporting VMI

Deliverables:

 

  5.3

System Requirements and Design Review – A system requirements and design review report will be submitted to BARDA containing the requirements and the design changes made to meet those requirements.

 

  5.4

Agreed upon CDC quality agreement for supporting VMI (if required)

 

  5.5

Verification and Validation

 

WBS# and Title

  

Milestone

  

Deliverable

5.5 Verification and Validation Report    V&V verifies product meets specifications and requirements    V&V Report

 

  5.5

Title: Verification and Validation Report

Objective/Description of Work: Verification & Validation are used to verify that the product meets the specifications and requirements and address the intended purpose. Verification demonstrates that the product meets specification and Validation demonstrates fitness of use for the intended purpose. Once V&V results are positive, the product is ready to release to manufacturing. Avita will submit a report to BARDA detailing the results of the V&V analysis.

Milestones:

 

  5.5

Testing and analysis indicate that the product meets specification and intended purpose.

Deliverables:

 

  5.5

V&V Report - Avita will submit a report to BARDA detailing the results of the V&V analysis.

 

6

QSR

 

  6.1

Quality System Preparedness

 

WBS# and Title

  

Milestone

  

Deliverable

6.1.3 3rd Party Audit    Audit completed    QSR Audit Report

 

Page 12 of 18


  6.1.3

Title: 3rd Party Audit

Objective/Description of Work: The US FDA Quality System Regulation (QSR) describes the environment under which medical device firms must operate. This task involves preparing the Avita quality systems for FDA review and inspection, and verifying compliance with FDA requirements. Avita hired an external 3rd party auditor to complete a QSR gap analysis. Following the audit a gap assessment was prepared and presented to Avita from the 3rd party auditor. Avita will develop a Gap Corrective Action plan to address any gaps identified. This will support PMA submission. Once the corrective action plan has been implemented and changes are in place a mock audit will be performed by a 3rd party auditor in preparation for an expected FDA inspection during PMA review.

Milestones:

 

  6.1.1

Gap Assessment

 

  6.1.2

Gap corrective action performed and all systems brought into compliance

 

  6.1.3

Mock QSR audit

Deliverables:

 

  6.1.3

QSR 3rd Party Audit Report - Avita will submit a report to BARDA detailing the results of the final QSR audit.

 

  6.2

Commercial Manufacturing

 

WBS# and Title

  

Milestone

  

Deliverable

6.2.1 Commercialization Plan and Gap Analysis    Completion of commercialization plans    Final Commercialization Plan
6.2.2.4 Validation Report    IQ/OQ/PQ process validations complete    Validation Report

 

  6.2.1

Title: Commercialization Plan and Gap Analysis

Objective/Description of Work: Perform a gap analysis to assess commercialization readiness and draft a commercialization plan in support of market entry. Tasks include, as necessary, establishing SKU#, Supply chain and vendor qualifications, raw material inventory, sterilization, packaging, and labeling, and lot release.

Milestones:

 

  6.2.1.1

Commercialization Gap Assessment completed

 

  6.2.1.2

Commercialization Plan Draft created, reviewed with BARDA

 

  6.2.1.3

Commercialization Plan finalized.

Deliverables:

 

  6.2.1.1

Commercialization Gap Assessment Report

 

  6.2.1.2

Commercialization Plan draft and final versions reviewed and submitted to BARDA.

 

  6.2.2.4

Title: Validation Report

 

Page 13 of 18


Objective/Description of Work: Process validation involves the collection and evaluation of data from the processes used to produce the product. Avita’s commercial manufacturer will lead the effort in manufacturing, under close supervision and collaboration with Avita. Sterile packaging will be a primary focus of the validation effort to ensure repeatable package integrity and valid sterilization processes. Process validations will include IQ/OQ/PQ and final validation. Avita will present a final report detailing the results of the validation analysis.

Milestones:

 

  6.2.2.1

IQ, Installation Qualification complete

 

  6.2.2.2

OQ, Operation Qualification complete

 

  6.2.2.3

PQ, Process Qualification complete

Deliverables:

 

  6.2.2.4

Validation Report - Avita will submit a report to BARDA detailing the results of the process validation analysis.

CLIN 0002 – Base Period

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.1.2 Product Manufacturing    Order Received    Initial Product
7.1.1.3 Deploy product to VMI sites    Product shipped to sites    Product deployed

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: Upon authorization from BARDA, Avita will cause the production and delivery of ReCell devices. Upon receiving the order Avita will authorize the manufacturer to procure supplies for the manufacture of the devices and preparing designated inventory locations.

Milestones:

 

  7.1.1.1

Order Received

 

  7.1.1.2

Delivery of specified quantity of units to VMI.

Deliverables:

 

  7.1.1.2

Initial Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices.

 

  7.1.1.3

Product integrated into VMI and available for deployment

 

  7.2

VMI Remote inventory management system

 

WBS# and Title

  

Milestone

  

Deliverable

7.2.1 - Gather VMI Requirements    All VMI requirements agreed upon with BARDA    VMI Requirements Document

 

  7.2.1

Title: Gather VMI Requirements

 

Page 14 of 18


Objective/Description of Work: Avita will work with USG to identify all VMI requirements, and prepare a document detailing the requirements.

Milestones:

 

  7.2.1

All VMI requirements agreed upon with BARDA

 

  Deliverables:

 

  7.2.1

VMI Requirements Document – Report detailing the agreed upon requirements for VMI.

 

  7.3

Sustainment/Stockpile Management

 

WBS# and Title

  

Milestone

  

Deliverable

7.4.1 Inventory Management    Quarterly inventory reports    Inventory Management Report

 

  7.3.1

Title: Inventory Management

Objective/Description of Work: Inventory management encompasses activities that occur after the inventory is on site and the inventory system is in operation. The purpose is to ensure ongoing compliance with the stockpiling requirements, and manage replenishment to ensure unit availability in emergency situations. Site environments will continue to be monitored through the lifetime of the contract for compliance with environmental requirements, and inventory controls will be followed. Site performance will be monitored periodically, supplemented by BARDA site visits. Plans will be executed to replenish expiring goods and units will be reworked as needed to maintain currency. Avita will present to BARDA Inventory Management Reports detailing the status and activities at all VMI locations at a frequency determined appropriate by BARDA and Avita.

Milestones:

 

  7.3.1

Quarterly inventory reports

Deliverables:

 

  7.3.1

Inventory Management Report

 

Page 15 of 18


Avita Medical OPTION SOW

 

Summary Table

 

CLIN

  

WBS 1st

Level
Element

  

Title

  

Objectives

0003    3    CoA Study   

•  Complete Post-Approval (conditions of approval) study, as required by FDA

0004    3, 4    Pediatric Studies   

•  Complete pediatric clinical trials per FDA requirements and BARDA guidance

0005    7   

Procurement

(Surge)

  

•  Execute acquisition contract

 

•  Expand VMI as necessary

 

•  Manage inventory

Overview

Avita has defined three option periods covering the Conditions of Approval (CoA) study after FDA approval of the ReCell Device (CLIN 0003), a Pediatric study to expand the indications for ReCell for a broader pediatric demographic, if necessary, for ReCell (CLIN 0004), and for the procurement of additional ReCell devices beyond the initial acquisition (CLIN0005). Note: Updated SOW(s) will be provided to BARDA based on FDA feedback to support the execution of each CLIN. The accompanying budget(s) will also be updated to align with the revised SOW(s).

The purpose of the CoA, CLIN 0003, is to provide longer-term evaluation of the ReCell device after FDA approval, in order to track and confirm that any post-market commitments are addressed by Avita.

The purpose of the Pediatric Study, CLIN 0004, is to expand the approved range of patients for ReCell, specifically for pediatric patients, beyond those originally approved during the PMA process. The specific study design and objectives will be based on the PMA approval outcomes as well as consultation with BARDA, and will be intended to expand the range of patients able to be treated by ReCell.

Surge acquisition, CLIN 0005, will support additional acquisition of ReCell devices by BARDA, CDC, or other stakeholders.

CLIN 0003 – Option – CoA Study

 

3

Clinical

 

  3.3

Post approval (Condition of Approval Stud

 

WBS# and Title

  

Milestone

  

Deliverable

3.3.1.2 Submit protocol to BARDA for review    Protocol developed    Study Protocol
3.3.6.1 Statistical analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.3.6.2 Clinical study report    CSR complete    CSR, review/submit to FDA

 

  3.3.6.4

Title: Final CoA CSR Review; Sufficiency for FDA submission

 

Page 16 of 18


Objective/Description of Work: Post approval (COA study) will be carried out if an additional study is required by FDA as a condition of PMA approval. If a COA study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.3.1.1

Protocol developed

 

  3.3.2.2

Last subject last visit

 

  3.3.6.1

CRO completes statistical analysis

 

  3.3.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.3.1.2

Study Protocol submitted to BARDA

 

  3.3.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.3.6.2

CSR, review/submit to FDA

CLIN 0004 – Option – Pediatric Study

 

3

Clinical

 

  3.2

Pediatric Study for Expanded Labeling

 

WBS# and Title

  

Milestone

  

Deliverable

3.2.1.2 Submit protocol to BARDA for review    Protocol developed    Study protocol
3.2.6.1 Statistical Analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.2.6.2 Clinical Study Report    CSR complete    CSR, review/submit to FDA

 

  3.2.8

Title: Final Pediatric CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pediatric study for expanded labeling will be carried out if requested by the BARDA to study younger children. If a pediatric study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.2.1.1

Protocol developed

 

  3.2.3.1

Last subject last visit

 

  3.2.6.1

CRO completes statistical analysis

 

  3.2.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

 

Page 17 of 18


Deliverables:

 

  3.2.1.2

Clinical Study Protocol

 

  3.2.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.2.6.2

Clinical Study Report (CSR)

 

4

Regulatory

 

  4.2.5

Pediatric Indication

 

WBS# and Title

  

Milestone

  

Deliverable

4.2.5.1 Pediatric IDE    FDA approval of pediatric IDE    Pediatric IDE application
4.2.5.3 Pediatric PMA supplement    FDA approval of expanded indication for pediatrics    Submission for Pediatric label expansion

 

  4.2.5

Title: Pediatric Indication

Objective/Description of Work: Avita will make the regulatory filings with FDA for both a pediatric IDE clinical trial and a PMA supplement for expansion of labeling for pediatric indication.

Milestones:

 

  4.2.5.2

FDA approval of pediatric IDE study

 

  4.2.5.4

FDA approval of pediatric indication

Deliverables:

 

  4.1.5.1

Pediatric IDE application.

 

  4.2.5.3

PMA supplement for pediatric indication

CLIN 0005 – Procurement (Surge)

7 Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received    Additional product to meet surge capacity

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

 

Page 18 of 18


ATTACHMENT #2

INVOICE/FINANCING REQUEST INSTRUCTIONS - FOR COST-REIMBURSEMENT TYPE

CONTRACTS

Format: Payment requests shall be submitted on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.

Number of Copies: Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

Frequency: Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Officer.

Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by pre-contract cost provisions.

Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs.

Contractor’s Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.

Currency: All BARDA contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

Costs Requiring Prior Approval: Costs requiring the Contracting Officer’s approval, including those set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request.

Invoice/Financing Request Identification: Each payment request shall be identified as either:

 

(a)

Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract performance period.

 

(b)

Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.


(c)

Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).

Preparation and Itemization of the Invoice/Financing Request: The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.

 

(a)

Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(b)

Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).

 

(c)

Invoice/Financing Request Number: Insert the appropriate serial number of the payment request.

 

(d)

Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared.

 

(e)

Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable).

 

(f)

Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order.

 

(g)

Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.

 

(h)

Total Fixed-Fee: Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract.

 

(i)

Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(j)

Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.


(k)

Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(l)

Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

 

(m)

Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(n)

Amount Billed - Cumulative: Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(o)

Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

 

  (1)

Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.

 

  (2)

Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.

 

  (3)

Accountable Personal Property: Include any property having a unit acquisition cost of $5,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property)(e.g. personal computers). Note this is not permitted for reimbursement without pre-authorization from the CO.

On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. Include reference to the following (as applicable):

-Item number for the specific piece of equipment listed in the Property Schedule, and

-COA number, if the equipment is not covered by the Property Schedule.

The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract.

 

  (4)

Materials and Supplies: Include all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required.

 

  (5)

Premium Pay: List remuneration in excess of the basic hourly rate.


  (6)

Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.

 

  (7)

Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

 

  (8)

Subcontract Costs: List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes, etc.).

 

  (9)

Other: Include all other direct costs not fitting into an aforementioned category. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.

 

(p)

Cost of Money (COM): Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if applicable.

 

(q)

Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.

 

(r)

Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.

 

(s)

Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.

 

(t)

Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.

 

(u)

Grand Totals

 

(v)

Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:

“I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.”

**Note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31.


ATTACHMENT #3

INVOICE/FINANCING REQUEST INSTRUCTIONS FOR FIXED PRICE TYPE CONTRACTS

General The Contractor shall submit vouchers or invoices as prescribed herein.

Format Standard Form l034, Public Voucher for Purchases and Services Other Than Personal, and Standard Form l035, Public Voucher for Purchases and Services Other than Personal—Continuation Sheet, and the payee’s letterhead or self-designed form should be used to submit claims for reimbursement.

Number of Copies: As indicated in the contract.

Frequency Invoices submitted in accordance with the Payment Clause shall be submitted monthly upon delivery of goods or services unless otherwise authorized by the Contracting Officer.

Preparation and Itemization of the Invoice The invoice shall be prepared as follows:

(a) Designated Billing Office and address:

HHS/ASPR/BARDA

330 Independence Ave, Room G640

Washington DC 20201

ATTN: Contracting Officer

(b) Invoice Number

(c) Date of Invoice

(d) Contract number and date

(e) Payee’s name and address. Show the Contractor’s name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the Contractor, or a different payee has been designated, then insert the name and address of the payee instead of the Contractor.

(f) Description of goods or services, quantity, unit price, (where appropriate), and total amount.

(g) Charges for freight or express shipments other than F.O.B. destination. (If shipped by freight or express and charges are more than $25, attach prepaid bill.)

(h) Equipment - If there is a contract clause authorizing the purchase of any item of equipment, the final invoice must contain a statement indicating that no item of equipment was purchased or include a completed form HHS-565, Report of Capitalized Nonexpendable Equipment.

Currency: Where payments are made in a currency other than United States dollars, billings on the contract shall be expressed, and payment by the United States Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.


ATTACHMENT #4 - SAMPLE INVOICE FORM

Company Name

 

Designated Billing Office Name and Address:

 

DHHS/OS/ASPR/AMCG

Attn: Contracting Officer

200 C St., S.W.

 

Washington, D.C. 20201

 

Contractor’s Address and Contact Information:

 

POC: Name of accountant or COO or signatory authority for invoice

Title:

Phone:

E-Mail:

 

TIN:

DUNS #:

  

Invoice/Finance Number:

 

Date Invoice Prepared:

 

Contract No. and Title:

 

Effective Date & Period of Performance:

 

Total Estimated Cost of Order:

 

Office of Acquisitions:

 

Contracting Officer (insert name here)

Office of Acquisitions Management, Contracts, and Grants (AMCG)

 

Central Point of Distribution:

This invoice represents reimbursable costs for the period from

 

Expenditure Category

   Amount Billed         
   Current      Cumulative      Contract  

Direct Costs:

        

Direct Labor

        

Fringe Benefits                             0.00%

        

Total Labor Costs:

        

Overhead                                              0.00%

        

Travel

        

Subcontracts

        

Consultant Fees

        

Materials and Supplies

        

Other

        

Total Direct Costs

        

G&A Rate                                              0.00%

        

Subtotal:

        

Fixed Fee                                                 0.0

        

Total Amount Claimed

        

Adjustments

        

Grand Total

   $ —          

I Certify that all payments are for appropriate purposes and in accordance with the contract.

 

 

Name/signature of signatory authority for invoicing


ATTACHMENT #5

RESEARCH PATIENT CARE COSTS

 

(a)

Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract.

 

(b)

Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative.

 

(c)

Prior to submitting an invoice for patient care costs under this contract, the Contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care.

 

(d)

The Contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement.

 

(e)

Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract.


Attachment 6

 

REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY

CONTRACTOR:

 

  

CONTRACT NUMBER:

 

ADDRESS:

  

REPORT DATE:

ADDRESS1:

  

ADDRESS2:

  

FISCAL YEAR:

CITY:

 

  

STATE:

ZIP:

  

 

     BEGINNING OF
PERIOD
     ADJUSTMENTS      END OF PERIOD  

CLASSIFICATION

   #ITEMS      VALUE      GFP
ADDED
     CAP
ADDED
     DELETIONS      #ITEMS      VALUE  

LAND >=$25K

                    

LAND <$25K

                    

OTHER REAL >=$25K

                    

OTHER REAL <$25K

                    

PROPERTY UNDER CONST >=$25K

                    

PROPERTY UNDER CONST <$25K

                    

PLANT EQUIP >=$25K

                    

PLANT EQUIP <$25K

                    

SPECIAL TOOLING >=$25K

                    

SPECIAL TOOLING <$25K

                    

SPECIAL TEST EQUIP >=$25K

                    

SPECIAL TEST EQUIP <$25K

                    

AGENCY PECULIAR >=$25K

                    

AGENCY PECULIAR <$25K

                    

MATERIAL >=$25K (CUMULATIVE)

              

PROPERTY UNDER MFR >=$25K

                    

PROPERTY UNDER MFR <$25K

                    

SIGNED BY:

 

SIGNATURE  

 

   DATE SIGNED:   

 

NAME PRINTED  

 

   Email   

 

TITLE  

 

   TELEPHONE   

 

Report of Government Owned, Contractor Held Property (Rev 10/2014)


Attachment 7

DISCLOSURE OF LOBBYING ACTIVITIES        Approved by OMB

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352        0348-0046

(See reverse for public burden disclosure.)

 

1. Type of Federal Action:

a. contract

b. grant

c. cooperative agreement

d. loan

e. loan guarantee

f. loan insurance

  

2. Status of Federal Action:

                    a. bid/offer/application

                    b. initial award

                    c. post-award

  

3. Report Type:

a. initial filing

b. material change

For Material Change Only:

year                 quarter                  

date of last report                         

 

4. Name and Address of Reporting Entity:

☐ Prime                        ☐ Subawardee

                                         Tier                 , if known:

 

Congressional District, if known:

  

5. If Reporting Entity in No. 4 is a Subawardee, Enter Name and Address of Prime:

 

Congressional District, if known:

6. Federal Department/Agency:   

7. Federal Program Name/Description:

 

CFDA Number, if applicable:                         

8. Federal Action Number, if known:   

9. Award Amount, if known:

    $                                 

10.a. Name and Address of Lobbying Registrant

        (if individual, last name, first name, MI):

  

b.  Individuals Performing Services (including address if different from No. 10a)

    (last name, first name, MI):

11. Information requested through this form is authorized by title 31 U.S.C. section 1352. This disclosure of lobbying activities is a material representation of fact upon which reliance was placed by the tier above when this transaction was made or entered into. This disclosure is required pursuant to 31 U.S.C. 1352. This information will be available for public inspection. Any person who fails to file the required disclosure shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

  

Signature:                                                                                               

 

Print Name:                                                                                            

 

Title:                                                                                                       

 

Telephone No.:                                         Date:                                     

 

Federal Use Only:    Authorized for Local Reproduction Standard Form LLL (Rev. 7-97)

PRINT


INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

This disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action. Complete all items that apply for both the initial filing and material change report. Refer to the implementing guidance published by the Office of Management and Budget for additional information.

 

  1.

Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

 

  2.

Identify the status of the covered Federal action.

 

  3.

Identify the appropriate classification of this report. If this is a followup report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.

 

  4.

Enter the full name, address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.

 

  5.

If the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address, city, State and zip code of the prime Federal recipient. Include Congressional District, if known.

 

  6.

Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department of Transportation, United States Coast Guard.

 

  7.

Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.

 

  8.

Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.”

 

  9.

For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.

 

  10.

(a) Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.

 

  (b)

Enter the full names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name, First Name, and Middle Initial (MI).

 

  11.

The certifying official shall sign and date the form, print his/her name, title, and telephone number.

 

According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503.


Cumulative Inclusion Enrollment Report

This report format should NOT be used for collecting data from study participants.

Study Title:                                                                                                                                                                                                                                     

Comments:                                                                                                                                                                                                                                     

 

Racial Categories

   Ethnic Categories      Total  
   Not Hispanic or Latino      Hispanic or Latino      Unknown/Not Reported Ethnicity  
   Female      Male      Unknown/
Not
Reported
     Female      Male      Unknown/
Not
Reported
     Female      Male      Unknown/
Not
Reported
 

American Indian/Alaska Native

                             

Asian

                             

Native Hawaiian or Other Pacific Islander

                             

Black or African American

                             

White

                             

More Than One Race

                             

Unknown or Not Reported

                             

Total

                             

 

PHS 398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015)    OMB No. 0925-0001/0002
   Page             Cumulative Inclusion Enrollment Report
EX-4.4

Exhibit 4.4

 

LOGO

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. Double asterisks denote omissions. AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER. UNDER DPAS (15 CFR 700) RATING PAGE OF PAGES 1 I 4 6 2. CONTRACT (Proc. Inst. Ident.) NO. HHSO100201500028C 3. EFFECTIVE DATE See Block 20C 4. REQUISITION/PURCHASE REQUEST/PROJECT NO. OS164565 5. ISSUED BY CODE ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 202016 ASPR—BARDA 6. ADMINISTERED BY (If other than Item 5) CODE See Block 5 ASPR—BARDA    7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State end ZIP Code) AVITA MEDICAL AMERICAS, LLC 1476585 9221 CORBIN AVE STE 220 NORTHRIDGE CA 91324 8. DELIVERY     â–¡ FOB ORIGIN ☒ In OTHER (See below)9 9. DISCOUNT FOR PROMPT PAYMENT 10. SUBMIT INVOICES (4 copies unless otherwise specified) TO THE ADDRESS SHOWN IN ITEM CODE 1476585 FACILITY CODE    11. SHIP TO/MARK FOR CODE HHS/OS/ASPR 200 C ST SW WASHINGTON DC 20201 HHS/OS/ASPR    12. PAYMENT WILL BE MADE BY CODE PSC Program Support Center 5600 Fishers Lane Room 17--21 Rockville MD 20852 PSC    13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: â–¡ 10 U.S.C. 2304 (c) ( ) â–¡ 41 U.S.C. 253(c) ( ) 14. ACCOUNTING AND APPROPRIATION DATA 2015.1990002.26201 15A. ITEM NO 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D. UNIT 15E. UNIT PRICE 15F. AMOUNT Continued    15G. TOTAL AMOUNT OF CONTRACT $16,901,424.00 16. TABLE OF CONTENTS (x) SEC Description Page(s) (x) SEC Description Page(s) PART I—THE SCHEDULE PART II—CONTRACT CLAUSES X A SOLICITATION/CONTRACT FORM . 01 X I CONTRACT CLAUSES 39 X B SUPPLIES OR SERVICES AND PRICES/COSTS 03 PART Ill -LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. X C DESCRIPTION/SPECS./WORK STATEMENT 10 X J LIST OF ATTACHMENTS 46 X O PACKAGING AND MARKING 11 PART IV—REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND ACCEPTANCE 12 K LIST OF ATTACHMENTS X F DELIVERIES OR PERFORMANCE 13    X G CONTRACT ADMINISTRATION DATA 23 L INSTRS., CONDS., AND NOTICES TO OFFERORS X H SPECIAL CONTRACT REQUIREMENTS 27 M EVALUATION FACTORS FOR AWARD CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18. (SEALED-BID PROCUREMENT} AS APPLICABLE 17. ☒CONTRACTOR’S AGREEMENT (Contractor is required to sign this document and return 2 copies to issuing office. Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents. (a) this award/contract, (b) the solicitation, if any, and (c) such problems, representations, certifications, and specifications as are attached or incorporated by reference herein. (Attachments are listed herein) 18. â–¡ SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on Solicitation Number                 including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the Items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents. (a) the Government’s solicitation and your bid, and (b) this award/contract. No further contractual document is necessary. (Block 10 should be checked only when awarding a sealed-bid contract.) 19A NAME AND TITLE OF SIGNE (Type or print) Timothy Rooney CFO/COO 20A. NAME OF CONTRACTING OFFICER Brooke Bernold 19B. NAME OF CONTRACTOR BY /s/ Timothy Rooney (Signature of person authorized to sign) 19C. DATE SIGNED 29 Sep 2015 20B. UNITED STATES OF AMERICA BY /s/ Brooke Bernold (Signature of the Contracting Officer) 20C. DATE SIGNED 29 Sept 2015 AUTHORIZED FOR REPRODUCTION Previous edition is NOT usable


LOGO

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE N/A PAGE OF PAGES 1 3 2. AMENDMENT/MODIFICATION NO. Modification 01 3. EFFECTIVE DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. N/A 5. PROJECT NO. (If applicable)    N/A 6. ISSUED BY CODE None 7. ADMINISTERED BY (If other then item 6) CODE N/A DCHHS/ASPR/AMCG 200 C Street, S.W. Washington, DC 20024    See Block 6 8. NAME AND ADDRESS OF CONTRACTOR (No., street. county. State and ZIP Code) (x) 9A. AMENDMENT OF SOLICITATION NO. AVITA MEDICAL AMERICAS, LLC 1476585 9221 CORBIN AVE STE 220 NORTHRIDGE, CA 91324    9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100201500028C    10B. DATED (SEE ITEM 13) 09/29/2015 CODE N/A FACILITY CODE                N/A    11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS â–¡ The above numbered solicitation is amended as set forth in Item 14. The hour and dale specified for receipt of Offers â–¡ is extended.    â–¡ is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified M the solicitation or as amended by one of the following methods: (a) By completing Items B and 15, and returning copies of the amendment (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate teller or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER If try virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and Is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A CAN# N/A 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. X B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation dale, etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor â–¡ is not. ☒ is required to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) PURPOSE: To add option CLINs 003, 004, and 0005A into PRISM as an administrative modification. Funds Obligated Prior to this Modification: $16,901,424 Funds Obligated with mod #04: $0                 Total Funds Obligated to Date: $16,901,424 PSC Code: 6505 Expiration date:    September 28, 2020 (Unchanged) Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged arid in lull farce and affect. 15A. NAME AND TITLE OF SIGNER (Type or print) Timothy Rooney, CFO/COO 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Brooke Bernold


15B. CONTRACTOR/OFFEROR

 

(Signature of person authorized to sign)

   15C. DATE SIGNED

 

5 Oct 2015

  

16B. UNITED STATES OF AMERICA

 

(Signature of Contracting Officer)

   16C. DATE SIGNED

 

10/7/15

 

CONTINUATION SHEET   

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201500028C

   PAGE  OF
   2    46

NAME OF OFFEROR OR CONTRACTOR

 

AVITA MEDICAL AMERICAS, LLC 1476585

 

ITEM NO.

(A)

  

SUPPLIES/SERVICES

(B)

   QUANTITY
(C)
     UNIT
(D)
     UNIT PRICE
(E)
     AMOUNT
(F)
 
  

Tax ID Number: 20-2578762

DUNS Number: 026723570

Autograft-Sparing Products for Definitive Care of

Burn Injuries

Appr. Yr.: 2015 CAN: 1990002 Object Class: 26201

FOB: Destination

Period of Performance: [**]/2015 to [**]/2020

           

1

  

ASPR-15-08829 — CLIN 0001 Advanced Development Studies for Licensure Approval of ReCell

POP: [**]/2015 – [**]/2020

Obligated Amount: [**]

              [ **] 

2

  

ASPR-15-08829 — CLIN 0002 Initial Purchase, Storage, and Delivery of ReCell Devices

POP: [**]/2015 – [**]/2020

Obligated Amount: [**]

              [ **] 

 

AUTHORIZED FOR REPRODUCTION

(4-86)

        OPTIONAL FORM 336
       

Sponsored by GSA

FAR (48 CFR) 53. 110


 

CONTINUATION SHEET

  

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201500028C

   PAGE OF
   2    2

NAME OF OFFEROR OR CONTRACTOR

 

AVITA MEDICAL AMERICAS, LLC 1476585

 

ITEM NO.
(A)
  

SUPPLIES/SERVICES

(B)

  

QUANTITY

(C)

  

UNIT

(D)

  

UNIT PRICE

(E)

   AMOUNT
(F)
 
   Add Item 3 as follows:            
3   

CLIN 0003 Phase IV post marketing

Commitments/Requirements

Amount: [**] (Option Line Item)

              0.00  
   Add Item 4 as follows:            
4   

CLIN 0004 Pediatric Study

Amount: [**] (Option Line Item)

              0.00  
   Add Item 5 as follows:            
5   

CLIN 0005A Additional Surge Capacity Less Than [**] Units

Amount: [**] (Option Line Item)

              0.00  
   Add Item 6 as follows:            
6   

CLIN 0005A Additional Surge Capacity [**] Units

Amount: [**] (Option Line Item)

              0.00  
   Add Item 7 as follows:            
7   

CLIN 0005A Additional Surge Capacity [**] Units

Amount: [**] (Option Line Item)

              0.00  
   Add Item 8 as follows:            
8   

CLIN 0005A Additional Surge Capacity [**] Units

Amount: [**] (Option Line Item)

              0.00  

 

AUTHORIZED FOR REPRODUCTION

(4-86)

         OPTIONAL FORM 336
        

Sponsored by GSA

FAR (48 CFR) 53. 110


PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE B.1.

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Avita Medical is developing ReCell, a unique technology that enables clinicians to use a small sample of your skin to restore healthy, normal skin when treating partial thickness or full thickness burns. The product has the potential to greatly improve the patient’s quality of life while reducing hospital stays and the need for reconstructive surgery. This product could find utility in day-to-day care, while simultaneously improving our capability to respond to mass casualty incidents.

Under the base period-of-performance, Avita Medical will further enhance their product to improve its commercial viability through the FDA approval process and potentially complete an initial purchase, storage, and delivery of product. The contract options may be exercised to perform follow-on studies as directed by the FDA, perform additional studies which further extend the ability to protect children and the elderly population, and purchase additional treatment courses.

The Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and several options as specified in this contract. The period of performance for the base period is 60 months.

ARTICLE B.2. BASE PERIOD

 

CLIN

  

Period of

Performance

  

Supplies/ Services

  

Total Est.
Cost

 

Fixed Fee
(7%)

 

Total Cost
Plus Fixed
Fee

COST REIMBURSEMENT

0001 (Base)

   [**]/2015 – [**]/2020    Licensure, approval, and clearance of product through the FDA    [**]   [**]   [**]
FIRM FIXED PRICE

CLIN

  

Period of Performance

  

Supplies/ Services

  

Units (# of
Product)

 

Unit Price

($)

 

Total ($)

0002

   [**]/2015 – [**]/2020    Initial Purchase, storage, and delivery of product    [**]   [**]   [**]

Total CLINS 1&2

   [**]/2015 – [**]/2020    See Above Descriptions        [**]

 

5


ARTICLE B.3.

OPTION PRICES

 

CLIN

  

Period of

Performance

  

Supplies/ Services

   Units (# of
Product)
  Unit Price
($)
  Total ($)
FIRM FIXED PRICE

0003 (Option Quantity)

   36 Months    Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)    N/A   N/A   [**]
COST REIMBURSEMENT

0004 (Option Quantity)

   60 Months    Pediatric Study (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)    [**]   [**]   [**]
FIRM FIXED PRICE

0005A (Option Quantity)

   36 Months    Additional Surge Capacity    Less than [**]   [**]   [**]

0005A (Option Quantity)

   36 Months    Additional Surge Capacity    [**]   [**]   [**]

0005A (Option Quantity)

   36 Months    Additional Surge Capacity    [**]   [**]   [**]

0005A (Option Quantity)

   36 Months    Additional Surge Capacity    [**]   [**]   [**]

Total CLINs 3-5

   60 Months    See Above Descriptions        [**]

 

ARTICLE B.4.

LIMITATIONS APPLICABLE TO DIRECT COSTS

 

a.

Items Unallowable Unless Otherwise Provided

Notwithstanding the clause FAR 52.216-7, Allowable Cost and Payment, incorporated in this contract, the costs of the following items or activities shall be unallowable as direct costs unless authorized in writing in advance by the Contracting Officer:

 

  1.

Acquisition, by purchase or lease, of any interest in real property;

 

  2.

Special rearrangement or alteration of facilities;

 

6


  3.

Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

 

  4.

Travel to attend general scientific meetings;

 

  5.

Unapproved foreign travel;

 

  6.

Consultant costs;

 

  7.

Subcontracts;

 

  8.

Patient care costs;

 

  9.

Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value.

 

  10.

Printing Costs (as defined in the Government Printing and Binding Regulations).

 

  11.

Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility.

 

  12.

Meeting room or conference space used for face to face meetings with USG staff in the performance of this contract. Justification for why the meeting cannot be held at a government facility must be provided. COA requests must be made at least (2) two weeks prior to meeting date.

 

b.

Travel Costs

 

  1.

Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred by the Prime Contractor in direct performance of this contract shall not exceed [**] without prior advance written approval by the Contracting Officer. Costs must be consistent with FAR 52.247-63 – Preference for U.S.-Flag Air Carriers.

 

  2.

The Contactor shall invoice and be reimbursed for all travel costs in accordance with FAR 31.703 and FAR 31.205-46, Contracts with Commercial Organizations, Travel Costs.

 

7


  3.

Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following:

 

  (i)

Meeting(s) and place(s) to be visited, with costs and dates;

 

  (ii)

Names(s) and title(s) of Contractor personnel to travel and their functions in the contract project;

 

  (iii)

Contract purpose to be served by the travel;

 

  (iv)

How travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of AMCG contract funds;

 

  (v)

How such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and

 

  (vi)

What additional functions may be performed by the travelers to accomplish other purpose of the contact and thus further benefit the project.

 

ARTICLE B.5.

ADVANCE UNDERSTANDINGS

 

a.

Subcontracts and Consultants

Award of any FFP subcontract or FFP consulting agreement in excess of $150,000 or any cost reimbursement subcontract or consulting agreement shall not proceed without the prior written consent of the Contracting Officer via a Contracting Officer Authorization (COA) Letter. COA letters will only be issued upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer within ten (10) days.

 

b.

Site Visits, Inspections and General Audits

At the discretion of the USG and independent of activities conducted by the Contractor, with 48 hours’ notice to the Contractor, the USG reserves the right to conduct site visits and inspections on an as needed basis, including collection of product samples and intermediates held by the Contractor, or subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall demonstrate cause for such visit and/or inspection. All costs reasonably incurred by the Contractor and subcontractor for such visit and/or inspection shall be allowable costs. The Contractor shall coordinate these visits and shall have the opportunity to accompany the USG on any such visits. Under time-sensitive or critical situations, the USG reserves the right to suspend the 48 hour notice to the Contractor.

If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government for review and acceptance.

 

   

If issues are identified during the audit, Contractor shall submit an issues report to the CO and COR within 10 business days detailing the finding and corrective action(s) of the audit.

 

   

COR and CO will review the issues report and provide a response to the Contractor within 10 business days.

 

   

Once corrective action is completed, the Contractor will provide a final report to the CO and COR within a time frame negotiated with the COR in writing after review of the issues report.

 

8


c.

QA Audits

BARDA reserves the right to participate in QA audits performed by the Contractor. Upon completion of the QA audit the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor, detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

 

   

Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications.

 

   

Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings.

 

d.

Man-in-Plant

At the discretion of the Government and seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility, who shall be subject to the Contractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s facility. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor plant.

 

e.

Confidential Treatment of Sensitive Information

The Contractor shall, to the extent permitted by law, guarantee strict confidentiality of the information/data that is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Notwithstanding the foregoing, such information/data shall not be deemed of a sensitive nature with respect to the Contractor for purposes of this contract if such information/data: (a) was already known to the Contractor; (b) was generally available or known, or was otherwise part of the public domain, at the time of its disclosure to the Contractor; (c) became generally available or known, or otherwise became part of the public domain, after its disclosure to, or, with respect to the information/data by, the Contractor through no fault of the Contractor; (d) was disclosed to the Contractor, other than under an obligation of confidentiality or non-use, by a third party who had no obligation to the Government that controls such information/data not to disclose such information/data to others; or (e) was independently discovered or developed by the Contractor, as evidenced by its written records, without the use of information/data belonging to the Government.

 

9


The Contractor may disclose information/data of a sensitive nature provided by the Government to the extent that such disclosure is: (a) made in response to a valid order of a court of competent jurisdiction (b) otherwise required by law, (c) made by the Contractor to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information/data

 

f.

Emergency Use Authorization (EUA)

The Contractor shall be responsible for generating the data to support the USG’s filing of a Pre-Emergency Use Authorization (Pre-EUA) package for use of the product prior to FDA licensure or approval during a declared emergency, declared potential emergency, or identification of material threat under an Emergency Use Authorization (EUA).

The Contractor commits to supporting the potential use of the product under a pre-EUA package as submitted by BARDA or the CDC/SNS. The Contractor shall supply BARDA or the CDC/SNS with the data needed to support such a submission, including expanded access INDs, right to hold product, right of reference to the Contractor’s Investigational New Drug (IND), or other application that contains the supporting data. The Contractor shall address any FDA comments on all pre-EUA packages as applicable. The Contractor shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder, etc.), that will be used to support use under EUA and approval/licensure.

Any product which has not received FDA approval or licensure, but has completed submission of the Pre-EUA package and has met the three (3) criteria listed below may be considered for procurement at the discretion of the USG. The Contractor would be required to demonstrate the three (3) essential criteria listed below for consideration of procurement of any unapproved products by seeking a COA. The COA shall include a product delivery schedule for consideration and documentation of the following:

 

   

Substantial evidence, including a validated process, of the Contractor’s ability to manufacture a product that would be identical to the commercial scale as required for product approval or licensure. A clear understanding of the outstanding risks, if any, for approval or licensure must be demonstrated through a risk register.

 

   

Completion of pivotal clinical studies with substantial evidence of safety and efficacy for the indicated use. A list of outstanding activities and targets for completion, adverse events/safety profile which do not pose unusual risks or challenges for FDA approval or licensure shall be provided.

 

   

Substantial evidence of product familiarity/acceptance for use in burn centers. The Contractor shall provide a list of burn centers familiar with the product, feedback received, and corrective actions required to address any concerns to ensure effective use of the product by burn care providers unfamiliar with the product. Evidence of the company’s ability to educate such providers on the use of the product (as allowed within the constraints of law) will be useful.

A tentative delivery schedule of product delivery to the inventory (acceptable as in the Quality Agreement) shall be required as part of the COA. The delivery schedule shall be updated periodically as necessary.

 

10


For information concerning EUA, please consult

http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127 and

http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/ MCMLegalRegulatoryandPolicyFramework/ucm182568.htm

 

g.

Sharing of contract deliverables within United States Government (USG)

In an effort to build a robust medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense and the National Institutes of Health, BARDA may share technical deliverables and data created in the performance of this contract with colleagues within the Integrated Portfolio. This advance understanding does not authorize BARDA to share financial information outside HHS. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the Government’s rights to deliverables submitted during performance as well as the Government’s rights to data contained within those deliverables.

 

h.

Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract. Billing of actual hours should be limited to total productive hours in a month.

 

i.

Option CLINS

The USG reserves the right to re-negotiate the option CLINS based availability of funds and feedback received from the FDA.

 

j.

Contract Number Designation

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:

HHSO100201500028C

 

h.

Quality Agreement

The Quality Agreement shall define, establish, and document the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. These documents shall be drafted, approved, and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement.

 

11


SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

ARTICLE C.1.

STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated [**], 2015 set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.

 

ARTICLE C.2.

REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

All reports required herein shall be submitted in electronic format. All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

 

ARTICLE C.3.

TWICE MONTHLY CONFERENCE CALLS

A conference call between the Contracting Officer’s Representative (COR) and the Contractor’s Project Leaders/delegates and designees shall occur twice-monthly or as directed by the Contracting Officer and Contracting Officer’s Representative. During this call the Contractor’s Project Leaders/delegates and designees will discuss the activities since the last call, any problems that have arisen and the activities planned until the next call takes place. The Contractor’s Project Leaders/delegates may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Representative.

 

ARTICLE C.4.

PROJECT MEETINGS

The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative. These meetings may include face-to-face meetings with AMCG/BARDA in Washington, D.C. and at work sites of the Contractor. Such meetings may include, but are not limited to, meetings of the Contractor to discuss study designs, site visits to the Contractor’s facilities, and meetings with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. Subject to the data rights provisions in this contract, the Contractor will provide data, reports, and presentations to groups of outside experts and USG personnel as required by the Contracting Officer and Contracting Officer’s Representative in order to facilitate review of contract activities.

 

12


SECTION D – PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the date, contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

 

13


SECTION E – INSPECTION AND ACCEPTANCE

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided under this contract.

For the purpose of this SECTION E, the designated Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer. The COR will assist in resolving technical issues that arise during performance. The COR however is not authorized to change any contract terms or authorize any changes in the Statement of Work or modify or extend the period of performance, or authorize reimbursement of any costs incurred during performance. The Contractor is advised to review FAR 52.243-1 Changes – Fixed Price Contracts Alternate V and FAR 52.243-2 Changes-Cost reimbursement contracts Alternative V, which is incorporated by reference into this contract in ARTICLE I.1.

Inspection and acceptance will be performed at:

Office of Acquisition Management, Contracts, and Grants (AMCG)

Office of the Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

200 C St. SW

Washington, D.C. 20024

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

The contract incorporates the following clause by reference with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

 

14


SECTION F – DELIVERIES OR PERFORMANCE

 

ARTICLE F.1.

PERIOD OF PERFORMANCE

The period of performance for this contract shall be from [**], 2015 through [**], 2020. The period of performance for the base period of this contract shall be consistent with the dates set forth in SECTION B. If the Government exercises option(s), the period of performance will be extended as described under in SECTION B of this contract.

 

ARTICLE F.2.

REPORTING REQUIREMENTS

In all cases the reports are intended to provide sufficient detail to understand the Contractor’s approach and progress to addressing the technical requirements. The reports supplement, and do NOT replace, routine (i.e. daily) communication between the COR and project manager and/or their designee(s) regarding project plans and progress.

 

  A.

Monthly Progress Report

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance updates as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

 

15


SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT — This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

Invoices: Summary of any invoices submitted during the reporting period.

A Monthly Progress Report will not be required in the same months that Annual or Final Technical Progress Reports are due.

 

  B.

Annual Progress Report

This report shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year.

The Contractor shall submit an Annual Progress Report on or before the 30th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE — This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

 

16


SECTION II Part C: TECHNICAL PROGRESS — This section shall document the results of work completed and costs incurred during the period covered in relation to proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES — This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK — This section shall include a summary of work proposed as an annual forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT — This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

Invoices: Summary of any invoices submitted during the reporting period.

An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due.

 

  C.

Draft Final Report and Final Report

These reports are to include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Progress Report shall be due forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report is due no later than 30 calendar days following the expiration date of the contract. The report shall conform to the following format:

Title Page: The title for these reports shall include the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.

SECTION II: RESULTS - A detailed description of the work performed and the results obtained including all expenses for the entire contract period of performance.

 

17


  D.

FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions.

 

  a.

Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall provide a formal contact report to BARDA. The Contractor shall forward the final minutes when available.

 

  b.

Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to BARDA. The Contractor shall forward the final minutes when available and if applicable.

 

  c.

The Contractor shall forward the dates and times of any formal meeting with the FDA and other regulatory agencies to BARDA as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.

 

  d.

The Contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA.

 

  e.

The Contractor shall forward Standard Operating Procedures (SOPs) upon request from COR.

 

  f.

The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR.

 

  g.

The Contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all site visits/audits conducted by the FDA or any other regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

 

  E.

Other Requirements/Deliverables

 

  a.

Integrated Master Project Plan

The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates the critical path to annual deliverables and Work Breakdown Structure (WBS) elements. Attention shall be placed on providing sufficient turnaround time for the USG (BARDA, FDA, and CDC) for review of critical documentation. The Contractor shall integrate to

 

18


demonstrate interdependencies among all CLINS. The Integrated Master Project Plan shall be incorporated into any potential contract and will be used to monitor performance of the contract. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  i.

Critical Path Milestones

The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project). This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  ii.

Work Breakdown Structure

The USG has provided a Contract Work Breakdown Structure (CWBS) template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) and the Contractor shall further delineate the CWBS to Level 5 as part of their Integrated Master Project Plan. The WBS shall be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  iii.

Risk Mitigation Plan/Matrix

The Contractor shall develop and maintain a risk management plan that highlights potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans. This plan shall reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) to be completed by any prospective Contractor. This report shall be due within 90 days of contract award. Updates shall be due as requested by the COR or Alternate COR.

 

  b.

Technology Packages

Technology packages developed under the contract that includes complete protocols must be submitted at the request of the BARDA Contracting Officer’s Representative. See FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14, Rights in Data. This report shall be due upon request from the COR or Alternate COR.

 

  c.

Experimental Protocols

The Contractor shall submit to the COR all study/experiment/test plans, designs, and protocols prior to execution for BARDA approval or upon request by the COR or Alternate COR when required.

 

19


  d.

Annual/Final Invention Report

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer.

 

  e.

Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission. Reports of final submission for publication shall be due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

 

  f.

Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than five (5) business days prior to the issuance of any potential press release.

 

  g.

Incident Security Report

The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products. Reports shall be due within 24 hours after occurrence of an activity or incident.

 

  i.

Security Plan

The Contractor shall submit a draft security plan within 90 days of contract award. A detailed security plan with any updates shall be submitted for approval at least three (3) months prior to the initiation of product procurement with proper documentation. The Contractor shall cooperate with USG representatives to develop a sustainable security plan to ensure continued security of the premises. Security plan updates are required when an incident security report has been filed.

 

  j.

Quality Management System (QMS) Plan

The Contractor shall provide a QMS plan within 90 days of contract award with updates at least three (3) months prior to initiation of product procurement and as directed by the COR or Alternate COR. The Contractor agrees to incorporate USG feedback and address concerns relating to QMS plans.

 

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  k.

Quality Agreement

The Quality Agreement shall define, establish, and document the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. These documents shall be drafted, approved, and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement. Quality Agreement is due at least three (3) months prior to initiation of product procurement or as directed by the COR or Alternate COR.

 

  l.

Vendor Managed Inventory (VMI) Plan

The Contractor shall develop a plan to establish VMI in alignment with the Quality Agreement Report. Interim draft plans shall be submitted to USG as part of the development process. Draft submission for review is due upon completion of pre-EUA package. Final submission is required to initiate product procurement through a COA. Documents shall be updated as required by the COR or Co-COR. Developmental updates should be reported in the monthly reports as requested by the COR or Alternate COR.

A minimum of three (3) product deliveries from different manufacturing lots shall be delivered and accepted by USG to the inventory (considered as substantial delivery to the inventory) before the Contractor shall invoice for the product payment.

 

  F.

Earned Value Management System Plan

 

  a.

Earned Value Management System Plan:

Subject to the requirements under HHSAR Clause 352.234-3, the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan as part of the monthly, annual, and final reports). The Seven Principles are:

 

  i.

Plan all work scope for the program to completion.

 

  ii.

Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.

 

  iii.

Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline.

 

  iv.

Use actual cost incurred and recorded in accomplishing the work performed.

 

21


  v.

Objectively assess accomplishments at the work performance level.

 

  vi.

Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.

 

  vii.

Use earned value information in the company’s management processes.

 

  viii.

Elements of EVMS shall be applied to all CLINs as part of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will establish, maintain and use to comply with EVMS requirements.

 

  b.

Performance Measurement Baseline Review (PMBR):

The Contractor shall submit a PMBR plan electronically via email to the CO and COR for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are as FOLLOWS:

 

  i.

Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and identification of inherent risks.

 

  ii.

Confirm the integrity of the Performance Measurement Baseline (PMB).

 

  iii.

Foster the use of EVM as a means of communication.

 

  iv.

Provide confidence in the validity of Contractor reporting

 

  v.

Identify risks associated with the PMB.

 

  vi.

Present any revised PMBs for approval.

 

  vii.

Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS) that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS (see http://www.acq.osd.mil/pm/).

 

  viii.

Present the Risk Management Plan.

 

22


  c.

Integrated Master Schedule

The Contractor shall submit an IMS electronically via email as outlined in a format agreed upon by BARDA to the COR and the Contracting Officer for approval prior to the initiation of any activities of sufficient size and cost to require EVMS. The Integrated Master Schedule shall be incorporated into the contract, and shall be used to monitor performance of the contract. The Contractor shall include the key milestones and Go/No Go decision gates. The Contractor shall include BARDA Portfolio Management Milestones (See the AMCG Business Toolkit for a description and sample (http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) in their IMS and provide monthly updates within their IMS. This IMS shall include the following fields at a minimum; baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. The Contractor shall deliver the Integrated Master Schedule, viewed at the work package level in MS Project file format.

 

  d.

Earned Value Contract Performance Report (EV-CPR)

 

  a.

The Offeror shall deliver an Earned Value Contract Performance Report (CPR) on a monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/). The Contractor shall provide Format 1, Format 3, and Format 5 only. Format 1 will be reported at the Work Breakdown Structure level agreed to by BARDA and the Contractor.

 

  b.

EV Variance thresholds will be negotiated with the Contractor post-award but for planning purposes will likely be (+/- 10%). In conjunction with the CPR, the Contractor shall provide a monthly update to the IMS with up to date performance data and shall include actual start/finish and projected start / finish dates.

 

  c.

The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)), and actual costs of work performed (ACWP) as captured in the Contractor’s EVM systems.

 

  d.

The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the COR. Such meetings may include, but are not limited to, site visits to the Contractor’s and/or subcontractor’s facilities, meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and Government-contracted subject matter experts as required by the BARDA COR in order to facilitate review of contract activities.

 

  e.

The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available 24 hours a day, seven days a week, to be notified in case of a public health emergency.

 

23


ARTICLE F.3.

DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work set forth in the Statement of Work dated September 29, 2015 set forth in SECTION J - List of Attachments of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule below:

 

Item
No.

  

Description

  

Addresses

  

Deliverable Schedule

1    Monthly Progress Report   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Reports are due on or before the 15th of each month following the end of each reporting period.
2    Annual Progress Report   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Reports are due on or before the 30th calendar day following the end of each reporting period.
3    Draft Final Progress Report   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Report is due 45 Calendar days prior to the expiration date of the contract.
4    Final Progress Report   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Report is due no later than 30 calendar days after the expiration date of the contract.
5    FDA/ Regulatory Agency Correspondence and Meeting Summaries   

COR:  (1) electronic copy

   Reports are due within 5 business days of each meeting for Contractor’s minutes, upon receipt of minutes from FDA/regulatory agency, and upon request from the COR or Alternate COR.
6   

Integrated Master Project Plan

 

-  Critical Path Milestones

 

-  Work Breakdown Structure

 

-  Risk Mitigation Plan/Matrix

  

COR:  (1) electronic copy

   Report is due within 90 days of contract award. Updates are due as requested by the COR or Alternate COR.
7    Technology Packages   

COR:  (1) electronic copy

   Upon request from the COR or Alternate COR.
8    Experimental Protocols for non- clinical animal studies or clinical studies   

COR:  (1) electronic copy

   Upon request from the COR or Alternate COR. Written approval from the COR or Alternate COR is required prior to the execution of the study.

 

24


Item
No.

  

Description

  

Addresses

  

Deliverable Schedule

9    Annual/Final Invention Report   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   An Annual Invention Report is due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report is due on or before the expiration date of the contract.
10    Publications   

COR:  (1) electronic copy

   Reports are due within 10 business days for manuscripts and 5 business days for abstracts.
11    Press Releases   

COR:  (1) electronic copy

   Reports/Notices are due for approval to the CO not less than five (5) business days prior to the issuance of any potential press release.
12    Incident Security Report   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Reports are due within 24 hours after occurrence of an activity or incident.
13    Security Plan   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Alternate COR.
14    Quality Management System (QMS) Plan   

COR:  (1) electronic copy

   Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Alternate COR.
15    Quality Agreement   

COR:  (1) electronic copy

   Agreement is due at least 3 months prior to product procurement or as directed by the COR or Alternate COR.
16    VMI Plan   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Plan is due upon completion of the Pre-EAU package.
17    Earned Value Management Requirements   

CO:   (1) electronic copy

 

COR:  (1) electronic copy

   Agreement is due at least 3 months prior to product procurement or as directed by the COR or Alternate COR.

Email Addresses: CO – [**]

COR – [**]

 

25


ARTICLE F.4.

FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address: http://www.acquisition.gov/far.

FAR 52.242-15, Stop Work Order (August 1989)

FAR 52.242-15, Alternate 1 (April 1984) is applicable to this contract.

 

26


SECTION G - CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1.

CONTRACTING OFFICER

The following Contracting Officer (CO) will represent the Government for the purpose of this contract:

Christopher Scott, CO

DHHS/OS/ASPR/AMCG

200 C St.

Washington, D.C. 20024

 

a.

The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the CO can make any changes to the terms, conditions, general provisions, specifications or other requirements of this contract.

 

b.

The Contracting Officer (CO) is the only person with authority to act as agent of the Government under this contract. Only the CO has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

 

c.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the CO, shall be considered grounds for deviation from this contract.

 

d.

The Government may unilaterally change its CO designation.

 

ARTICLE G.2.

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

[**]

Contracting Officer’s Representative

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

[**]

[**]

Mailing Address:

200 C St.

Washington, D.C. 20024

 

27


Alternate COR:

[**]

Alternate Contracting Officer’s Representative (COR)

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

[**]

[**]

Mailing Address:

330 Independence Avenue, SW

Washington, D.C. 20201

The COR is responsible for:

 

a.

Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

 

b.

Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;

 

c.

Performing technical evaluation as required;

 

d.

Performing technical inspections and assisting the Contracting Officer in acceptances of deliverables required by this contract; and

 

e.

Assisting in the resolution of technical problems encountered during performance.

 

f.

The Government may unilaterally change its COR designation(s).

 

ARTICLE G.3.

KEY PERSONNEL

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individuals are considered to be essential to the work being performed hereunder:

 

Name

  

Title

[**]    [**]
[**]    [**]
[**]    [**]
[**]    [**]

 

28


ARTICLE G.4.

INVOICE SUBMISSION

 

a.

The Contractor shall submit an electronic copy of contract monthly invoices/financial reports to the Contracting Officer as defined above, in ARTICLE G of this contract.

 

b.

Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests made a part of the contract at Section J, Attachments 2 & 3.

 

c.

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

 

d.

The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any options for additional quantities (See estimated costs under Articles B.2 and B.3) and the reasons for the variance. Also refer to the requirements of FAR Clause 52.232-20, Limitation of Cost.

 

e.

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor’s name, contract number, and unique invoice number.

 

f.

All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment.

 

ARTICLE G.5.

INDIRECT COST RATES

 

1)

The following interim provisional indirect rates will be utilized for billing purposes during the period of performance: Fringe benefits at [**], and Overhead (G&A) at [**]. Final rate proposals must be sent to the Contracting Officer, within 6 months of the fiscal year end. See FAR Clause 52.216-7, Allowable Cost and Payment.

 

ARTICLE G.6.

REIMBURSEMENT OF COST

 

1)

The Government shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:

 

  a)

All direct materials and supplies that are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders.

 

  b)

All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.

 

  c)

All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.

 

29


  d)

Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the following:

 

  i.

Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).

 

  ii.

Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.

 

  iii.

Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

 

  iv.

Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.

 

ARTICLE G.7.

POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

  1.

Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) will be prepared Annually as to coincide with the Anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

 

  2.

Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure website for review and comment at the following:

http://cpars.gov

 

ARTICLE G.8.

CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting the contract number HHSO100201500028C from Page 1 of the contract.

 

30


ARTICLE G.9.

GOVERNMENT PROPERTY

 

1.

In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated into this contract by reference. This document can be accessed at:

http://www.hhs.gov/hhsmanuals/             (HHS Logistics Management Manual)

Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

 

2.

Notwithstanding the provisions outlined in the HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated in this contract in paragraph 1. above, the Contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

 

3.

Title will vest in the Government for equipment purchased as a direct cost.

SECTION H - Special Contract Requirements

 

ARTICLE H.1.

PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

 

a.

The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

 

b.

The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

 

c.

If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those Contractors with approved Human Subject Assurances.

 

31


ARTICLE H.2.

CLINICAL RESEARCH

These Clinical Terms apply to all contracts that involve clinical research.

The Government shall have unlimited rights to all protocols, data generated from the execution of these protocols, and final reports, funded by the Government under this contract, as defined in Rights in Data Clause in FAR 52.227-14. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form, to ensure the Government has the ability to review and distribute the deliverables, as the Government deems necessary.

H.2.1 Safety and Monitoring Issues

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval

Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number.

The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC.

To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following:

 

1.

All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.

 

2.

All changes in informed consent documents, identified by version number, date, or both and dates it is valid.

 

3.

Termination or temporary suspension of patient accrual.

 

4.

Termination or temporary suspension of the protocol.

 

5.

Any change in IRB approval.

 

6.

Any other problems or issues that could affect the participants in the studies.

 

32


Contractors must notify BARDA through the Contracting Officer’s Representative (COR) and Contracting Officer (CO) of any of the above changes within 24 hours from the time the Contractor becomes aware of the change by email, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC.

If a clinical protocol has been reviewed by an Institutional Bio-safety Committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

H.2.2. Data and Safety Monitoring Requirements

The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractors and Subcontractors as the Government deems necessary. The type of monitoring to be used shall be mutually agreed upon between the Contractor and the Government before enrollment starts. Discussions with the responsible BARDA COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following:

 

  1.

Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.

 

  2.

Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.

 

  3.

Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB.

When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the Government before enrollment starts.

Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.

 

33


H.2.3. BARDA Protocol Review Process Before Patient Enrollment Begins

BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must provide the following (as applicable) for review and approval by the Government:

 

  1.

Clinical research protocol to be submitted for approval by the IRB identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria;

 

  2.

Informed consent document, identified by version number, date, or both and date it is valid;

 

  3.

Plans for the management of side effects;

 

  4.

Procedures for assessing and reporting adverse events;

 

  5.

Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory;

 

  6.

Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.

BARDA comments will be forwarded to the Contractor within two weeks (10 business days) of receipt of the above information. The Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by the BARDA COR to the satisfaction of the Government before patient accrual or participant enrollment can begin. After the Government receives the corrected documentation, a written protocol approval will be provided by the COR to the Contractor. This written approval provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by the Government.

Documentation of IRB approval, including OHRP FWA number, IRB registration number, and IRB and name, must be provided to the BARDA COR within 24 hours of receipt by the Contractor.

H.2.4. Required Time-Sensitive Notification

Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible BARDA Contracting Officer’s representative (COR) as follows:

 

  1.

Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the BARDA program officer or the Contracting Officer’s Representative within 24 hours of FDA notification.

 

34


  2.

Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the BARDA Contracting Officer’s Representative within 24 hours of FDA notification.

 

  3.

IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the BARDA Contracting Officer’s Representative within 24 hours of FDA notification.

 

  4.

Expedited safety reports – shall be sent to the BARDA COR concurrently with the report to FDA.

 

  5.

Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the BARDA annually.

In case of problems or issues, the BARDA COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed.

Safety reporting for research not performed under an IND or IDE.

Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the BARDA Contracting Officer’s Representative and the Contractor.

 

ARTICLE H.3.

HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

 

ARTICLE H.4.

NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

 

ARTICLE H.5.

ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

 

ARTICLE H.6.

RESTRICTIONS ON ABORTIONS

The Contractor shall not use funds for any abortion.

 

35


ARTICLE H.7.

CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with the March 4, 1997 Presidential Memorandum entitled “Prohibition on Federal Funding for Cloning of Human Beings”, federal funds may not be used for cloning of human beings.

 

ARTICLE H.8.

DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

 

ARTICLE H.9.

OMB CLEARANCE

In accordance with HHSAR 352.201-70, Paperwork Reduction Act of 1980 (44 U.S.C. section 3501), the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer’s Representative (COR) and the Contracting Officer has issued written approval to proceed.

 

ARTICLE H.10.

RESEARCH INVOLVING HUMAN FETAL TISSUE

All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.

The Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.

 

ARTICLE H.11.

REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

 

36


ARTICLE H.12.

PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

 

ARTICLE H.13.

RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

 

ARTICLE H.14.

CERTIFICATION OF FILING AND PAYMENT OF TAXES

The Contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

 

ARTICLE H.15.

ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE

 

a.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

 

b.

Accordingly, any Offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

 

c.

The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, Offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows Offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

 

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In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, Offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

 

d.

Respondents to this solicitation must identify any exception to Section 508 requirements. If a Offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

 

ARTICLE H.16.

FULL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-3 (October 2008) with ALTERNATE I (October 2008)

 

a.

The Contractor shall use an Earned Value Management System (EVMS) that is compliant with the guidelines in ANSI/EIA Standard-748 (current version at the time of award) to manage this contract. If the Contractor’s current EVMS is not compliant at the time of award, see paragraph (b) of this clause. The Contractor shall submit EVM reports in accordance with the requirements of this contract.

 

b.

If, at the time of award, the Contractor’s EVM system is not in compliance with the EVMS guidelines in ANSI/EIA Standard-748 (current version at time of award), the Contractor shall:

 

  a.

Apply the current system to the contract; and

 

  b.

Take necessary and timely actions to meet the milestones in the Contractor’s EVMS plan approved by the Contracting Officer.

 

c.

HHS will not formally validate or accept the Contractor’s EVMS with respect to this contract. The use of the Contractor’s EVMS for this contract does not imply HHS acceptance of the Contractor’s EVMS for application to future contracts. The Contracting Officer or designee will conduct a Compliance Review to assess the Contractor’s compliance with its approved plan. If the Contractor does not follow the approved implementation schedule or correct all resulting system deficiencies noted during the Compliance Review within a reasonable time, the Contracting Officer may take remedial action that may include, but is not limited to, suspension of or reduction in progress payments, or a reduction in fee.

 

d.

HHS will conduct a Performance Measurement Baseline Review (PMBR). If a pre-award PMBR has not been conducted, a post-award PMBR will be conducted by HHS as early as practicable, but no later than ninety (90) days after contract award. The Contracting Officer may also require a PMBR as part of the exercise of an option or the incorporation of a major modification.

 

e.

The Contractor shall provide access to all pertinent records and data requested by the Contracting Officer or a duly authorized representative as necessary to permit Government surveillance to ensure that the EVMS conforms, and continues to conform to the requirements referenced in paragraph (a) of this clause.

 

f.

The Contractor shall require the subcontractors specified below to comply with the requirements of the clause:

 

38


ARTICLE H.17.

CONFIDENTIALITY OF INFORMATION

 

a.

Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

 

b.

The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the “Disputes” clause.

 

c.

If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

 

d.

Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

 

e.

Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor shall obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

 

f.

Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

 

g.

The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

 

ARTICLE H.18.

INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR CONFLICTS OF INTERESTS

The Institution (includes any Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under BARDA contracts, or proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51 &idno=45

 

39


As required by 45 CFR Part 94, the Institution shall, at a minimum:

 

a.

Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator’s reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

 

  1.

With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;

 

  2.

With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest; or

 

  3.

Intellectual property rights and interests, upon receipt of income related to such rights and interest.

Significant financial interests do not include the following:

 

  1.

Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and

 

  2.

Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

 

b.

Require each Investigator to complete training regarding the Institution’s financial conflicts of interest policy prior to engaging in research related to any BARDA funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.

 

c.

Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the BARDA funded research.

 

d.

Require that each Investigator who is planning to participate in the BARDA funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interest (and those of the Investigator’s spouse and dependent children) no later than the date of submission of the Institution’s proposal for BARDA funded research. Require that each Investigator who is participating in the BARDA funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.

 

40


e.

Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator’s significant financial interest is related to BARDA funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the BARDA funded research.

 

f.

Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).

 

g.

Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).

 

h.

Maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures, and all actions under the Institution’s policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

 

i.

Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.

 

j.

Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors titled “Certification of Institutional Policy on Financial Conflicts of Interest”.

If the failure of an Institution to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the BARDA funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the BARDA funded research project.

The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Institution’s review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of a financial conflict of interests. The Contracting Officer may require submission of the records or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer may decide that a particular financial conflict of interest will bias the objectivity of the BARDA funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

If the Contracting Officer determines that BARDA funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

 

41


ARTICLE H.19.

PUBLICATION AND PUBLICITY

The Contractor shall acknowledge the support of the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

“This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500028C

Press Releases:

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money that: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by non-Governmental sources.

 

ARTICLE H.20.

ACCESS TO DOCUMENTATION/DATA

The Government shall have physical and electronic access to all documentation and data generated under this contract, including: all data documenting Contractor performance, all data generated, all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. Contractor shall provide the Government with an electronic copy of all correspondence with the FDA within 24 hours of receipt. The Government shall acquire unlimited rights to all data funded under a contract awarded in response to this RFP in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

 

ARTICLE H.21.

DISSEMINATION OF INFORMATION

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

 

ARTICLE H.22.

DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

 

42


ARTICLE H.23.

IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data generated under this contract and determined by HHS to be relevant to this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

 

ARTICLE H.24.

CONFLICT OF INTEREST

The Contractor represents and warrants that, to the best of the Contractor’s knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR 2.101 and Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

 

ARTICLE H.25.

IN-PROCESS REVIEW

In Process Reviews (IPR) will be conducted at the discretion of the Government to discuss the progression of the milestones. The Government reserves the right to revise the milestones and budget pending the development of the project. Deliverables may be required when the IPRs are conducted. The Contractor’s success in completing the required tasks under each work segment must be demonstrated through the Deliverables and Milestones specified under SECTION F. Those deliverables will constitute the basis for the Government’s decision, at its sole discretion, to proceed with the work segment, or unilaterally institute changes to the work segment, or terminate the work segment.

IPRs may be scheduled at the discretion of the Government to discuss progression of the contract. The Contractor shall provide a presentation following a prescribed template which will be provided by the Government at least 30 days prior to the IPR. The Contractor shall provide a draft presentation to the Contracting Officer at least 10 days prior to the IPR.

 

ARTICLE H.26.

PRIVACY ACT APPLICABILITY

 

1)

Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://www.gpoaccess.gov/cfr/index.html

 

43


2)

The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.

 

3)

The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm

 

ARTICLE H.27.

QA AUDIT REPORTS

BARDA reserves the right to participate in QA audits. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

 

   

Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications. The Contractor shall notify the CO and COR reasonably in advance of upcoming QA audit so that Government personnel may participate in person at BARDA’s discretion.

 

   

Contractor shall notify the COR and CO within 5 business days of report completion.

 

ARTICLE H.28.

BARDA AUDITS

Contractor shall accommodate periodic or ad hoc site visits by the Government. If the Government, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government.

 

   

If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.

 

   

COR and CO will review the report and provide a response to the Contractor with 10 business days.

 

   

Once corrective action is completed, the Contractor will provide a final report to the CO and COR.

 

ARTICLE H.29.

SECURITY REPORTING REQUIREMENT

Violations of established security protocols shall be reported to the CO and COR upon discovery within 24 hours of its receipt of any compromise, intrusion, loss or interference of its security processes and procedures. The Contractor shall ensure that all software components that are not required for the operation and maintenance of the database/control system has been removed and/or disabled. The Contractor shall provide to the CO and the COR information appropriate to Information and Information Technology software and service updates and/or workarounds to mitigate all vulnerabilities associated with the data and shall maintain the required level of system security.

 

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The Contractor will investigate violations to determine the cause, extent, loss or compromise of sensitive program information, and corrective actions taken to prevent future violations. The CO in coordination with BARDA will determine the severity of the violation. Any contractual actions resulting from the violation will be determined by the CO.

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/FAR/ . HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html.

General Clauses for Cost-Reimbursement/Fixed Price Research and Development Contract

 

(1)

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

Reg

  

Clause

  

Date

  

Clause Title

FAR    52.202-1    Nov 2013    Definitions
FAR    52.203-3    Apr 1984    Gratuities
FAR    52.203-5    May 2014    Covenant Against Contingent Fees
FAR    52.203-6    Sep 2006    Restrictions on Subcontractor Sales to the Government
FAR    52.203-7    May 2014    Anti-Kickback Procedures
FAR    52.203-8    May 2014    Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
FAR    52.203-10    May 2014    Price or Fee Adjustment for Illegal or Improper Activity
FAR    52.203-12    Oct 2010    Limitation on Payments to Influence Certain Federal Transactions
FAR    52.203-13    Apr 2010    Contractor Code of Business Ethics and Conduct
FAR    52.203-14    Dec 2007    Display of Hotline Poster(s)
FAR    52.203-17    Apr 2014    Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights
FAR    52.204-4    May 2011    Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
FAR    52.204-7    Jul 2013    System for Award Management
FAR    52.204-10    Jul 2013    Reporting Executive Compensation and First-Tier Subcontract Awards
FAR    52.204-13    Jul 2013    System for Award Management Maintenance
FAR    52.209-6    Aug 2013    Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
FAR    52.209-10    Dec 2014    Prohibition on Contracting with Inverted Domestic Corporations
FAR    52.210-1    Apr 2011    Market Research
FAR    52.215-2    Oct 2010    Audit and Records – Negotiation
FAR    52.215-8    Oct 1997    Order of Precedence - Uniform Contract Format
FAR    52.215-10    Aug 2011    Price Reduction for Defective Cost or Pricing Data
FAR    52.215-11    Aug 2011    Price Reduction for Defective Certified Cost or Pricing Data—Modifications.
FAR    52.215-12    Oct 2010    Subcontractor Certified Cost or Pricing Data
FAR    52.215-13    Oct 2010    Subcontractor Certified Cost or Pricing Data—Modifications
FAR    52.215-15    Oct 2010    Pension Adjustments and Asset Reversions

 

45


Reg

  

Clause

  

Date

  

Clause Title

FAR    52.215-18    Jul 2005    Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions
FAR    52.215-19    Oct 1997    Notification of Ownership Changes
FAR    52.215-21    Oct 2010    Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -Modifications
FAR    52.215-23    Oct 2009    Limitations on Pass-Through Charges
FAR    52.216-7    Jun 2013    Allowable Cost and Payment
FAR    52.216-8    Jun 2011    Fixed Fee
FAR    52.219-8    Oct 2014    Utilization of Small Business Concerns
FAR    52.219-28    July 2013    Post-Award Small Business Program Representation
FAR    52.222-1    Feb 1997    Notice to the Government of Labor Disputes
FAR    52.222-2    Jul 1990    Payment for Overtime Premiums
FAR    52.222-3    Jun 2003    Convict Labor
FAR    52.222-21    Apr 2015    Prohibition of Segregated Facilities
FAR    52.222-26    Apr 2015    Equal Opportunity
FAR    52.222-35    Jul 2014    Equal Opportunity for Veterans
FAR    52.222-36    Jul 2014    Equal Opportunity for Workers with Disabilities
FAR    52.222-37    Jul 2014    Employment Reports on Veterans
FAR    52.222-40    Dec 2010    Notification of Employee Rights Under the National Labor Relations Act
FAR    52.222-43    May 2014    Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts)
FAR    52.222-50    Mar 2015    Combating Trafficking in Persons
FAR    52.222-54    Aug 2013    Employment Eligibility Verification
FAR    52.223-6    May 2001    Drug-Free Workplace
FAR    52.223-18    Aug 2011    Encouraging Contractor Policy to Ban Text Messaging While Driving
FAR    52.224-1    April 1984    Privacy Act Notification
FAR    52.224-2    April 1984    Privacy Act
FAR    52.225-13    Jun 2008    Restrictions on Certain Foreign Purchases
FAR    52.227-1    Dec 2007    Authorization and Consent, Alternate 1 (APR 1984)
FAR    52.227-2    Dec 2007    Notice and Assistance Regarding Patent and Copyright Infringement
FAR    52.227-3    Apr 1984    Patent Indemnity
FAR    52.227-11    May 2014    Patent Rights – Ownership by the Contractor
FAR    52.227-14    May 2014    Rights in Data - General
FAR    52.228-7    Mar 1996    Insurance – Liability to Third Persons
FAR    52.229-3    Feb 2013    Federal, State and Local Taxes
FAR    52.230-2    May 2014    Cost Accounting Standards
FAR    52.230-6    June 2010    Administration of Cost Accounting Standards
FAR    52.232-1    Apr 1984    Payments
FAR    52.232-2    Apr 1984    Payments under Fixed-Price Research and Development Contracts
FAR    52.232-8    Feb 2002    Discounts for Prompt Payment
FAR    52.232-9    Apr 1984    Limitation on Withholding of Payments
FAR    52.232-11    Apr 1984    Extras
FAR    52.232-17    May 2014    Interest
FAR    52.232-20    Apr 1984    Limitation of Cost
FAR    52.232-23    May 2014    Assignment of Claims
FAR    52.232-25    Jul 2013    Prompt Payment
FAR    52.232-33    Jul 2013    Payment by Electronic Funds Transfer—System for Award Management

 

46


Reg

  

Clause

  

Date

  

Clause Title

FAR    52.233-1    May 2014    Disputes
FAR    52.233-3    Aug 1996    Protest After Award, Alternate I
FAR    52.233-4    Oct 2004    Applicable Law for Breach of Contract Claim
FAR    52.242-1    Apr 1984    Notice of Intent to Disallow Costs
FAR    52.242-3    May 2014    Penalties for Unallowable Costs
FAR    52.242-4    Jan 1997    Certification of Final Indirect Costs
FAR    52.242-13    Jul 1995    Bankruptcy
FAR    52.242-15    Aug 1989    Stop Work Order, Alternate I (Aug 1984)
FAR    52.243-1    Aug 1987    Changes - Fixed-Price Alternate V (Apr 1984).
FAR    52.243-2    Aug 1987    Changes—Cost-Reimbursement Alternate V (Apr 1984).
FAR    52.243-7    Apr 1984    Notification of Changes
FAR    52.244-2    Oct 2010    Subcontracts, Alternate 1 (Jun 2007)
FAR    52.244-5    Dec 1996    Competition in Subcontracting
FAR    52.244-6    Apr 2015    Subcontracts for Commercial Items
FAR    52.245-1    Apr 2012    Government Property
FAR    52.245-9    Apr 2012    Use and Charges
FAR    52.246-23    Feb 1997    Limitation of Liability.
FAR    52.246-25    Feb 1997    Limitation of Liability—Services
FAR    52.248-1    Oct 2010    Value Engineering
FAR    52.249-2    Apr 2012    Termination for the Convenience of the Government (Fixed-Price)
FAR    52.249-6    May 2004    Termination (Cost-Reimbursement)
FAR    52.249-8    Apr 1984    Default (Fixed-Price Supply and Service)
FAR    52.249-9    Apr 1984    Default (Fixed-Price Research and Development)
FAR    52.249-14    Apr 1984    Excusable Delays
FAR    52.253-1    Jan 1991    Computer Generated Forms

 

(2)

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

Reg

  

Clause

  

Date

  

Clause Title

HHSAR    352.202-1    Jan 2006    Definitions - with Alternate paragraph (h)
HHSAR    352.203-70    Mar 2012    Anti-Lobbying
HHSAR    352.216-70    Jan 2006    Additional Cost Principles
HHSAR    352.222-70    Jan 2010    Contractor Cooperation in Equal Employment Opportunity Investigations
HHSAR    352.223-70    Sept 2010    Safety and Health
HHSAR    352.227-70    Jan 2006    Publications and Publicity
HHSAR    352.228-7    Dec 1991    Insurance - Liability to Third Persons
HHSAR    352.231-70    Jan 2006    Salary Rate Limitation
HHSAR    352.231-71    Jan 2001    Pricing of Adjustments
HHSAR    352.233-71    Jan 2006    Litigation and Claims
HHSAR    352.242-70    Jan 2006    Key Personnel
HHSAR    352.242-73    Jan 2006    Withholding of Contract Payments
HHSAR    352.242-74    Apr 1984    Final Decisions on Audit Findings

 

47


ARTICLE I.2.

ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

 

a.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

  1.

FAR 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

 

  2.

FAR 52.227-16, Additional Data Requirements (June 1987).

 

ARTICLE I.3.

ADDITIONAL HHSAR CLAUSES – IN FULL TEXT

352.231-70 Salary rate limitation (August 2012)

 

  1.

Pursuant to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date an expense is incurred.

 

  2.

For purposes of the salary rate limitation, the terms “direct salary,” “salary”, and “institutional base salary”, have the same meaning and are collectively referred to as “direct salary”, in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative [F&A] costs).

Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract or order; it merely limits the portion of that salary that may be paid with Federal funds.

 

  1.

The salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless of the rate initially used to establish contract or order funding.

 

  2.

See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels that apply to the current and prior periods.

 

ARTICLE I.4.

ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT

FAR 52.217-7 Option for Increased Quantity-Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

 

48


FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

 

a.

The Government may extend the term of this contract by written notice to the Contractor within 30 Days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

 

b.

If the Government exercises this option, the extended contract shall be considered to include this option clause.

 

c.

The total duration of this contract, including the exercise of any options under this clause, shall not exceed 8 years.

FAR 52.219-1 Small Business Program Representations (Oct 2014)

 

a.

1.                   The North American Industry Classification System (NAICS) code for this acquisition is 541711.

 

  2.

The small business size standard is 500 employees.

 

  3.

The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

 

b.

Representations.

 

  1.

The Offeror represents as part of its offer that it [X] is, [_] is not a small business concern.

 

  2.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents, for general statistical purposes, that it [_] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.

 

  3.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents as part of its offer that it [ ] is, [X] is not a women-owned small business concern.

 

  4.

Women-owned small business (WOSB) concern eligible under the WOSB Program. [Complete only if the Offeror represented itself as a women-owned small business concern in paragraph (b)(3) of this provision.] The Offeror represents as part of its offer that—

 

  (i)

It [_] is, [X] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

 

  (ii)

(ii) It [_] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(4)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ____________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

 

49


  5.

Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a women-owned small business concern eligible under the WOSB Program in (b)(4) of this provision.] The Offeror represents as part of its offer that—

 

  (i)

It [_] is, [X] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

 

  (ii)

It [_] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (b)(5)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The Offeror shall enter the name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: ____________.] Each EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

 

  6.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents as part of its offer that it [_] is, [X] is not a veteran-owned small business concern.

 

  7.

[Complete only if the Offeror represented itself as a veteran-owned small business concern in paragraph (b)(6) of this provision.] The Offeror represents as part of its offer that is [_] is, [_] is not a service-disabled veteran-owned small business concern.

 

  8.

[Complete only if the Offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The Offeror represents, as part of its offer, that –

 

  (i)

It [_] is, [X] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and

 

  (ii)

It [_] is, [X] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph (b)(8)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture: ____________.] Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone representation.

 

50


c.

Definitions. As used in this provision—

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business concern eligible under the WOSB Program. “Service-disabled veteran-owned small business concern”—

 

  1.

Means a small business concern—

 

  (i)

Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

 

  (ii)

The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

 

  2.

Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

“Small business concern,” means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and the size standard in paragraph (a) of this provision.

“Veteran-owned small business concern” means a small business concern—

 

  1.

Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

 

  2.

The management and daily business operations of which are controlled by one or more veterans.

“Women-owned small business concern,” means a small business concern –

 

  1.

That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

 

  2.

Whose management and daily business operations are controlled by one or more women.

“Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

 

d.

Notice.

 

  1.

If this solicitation is for supplies and has been set aside, in whole or in part, for small business concerns, then the clause in this solicitation providing notice of the set-aside contains restrictions on the source of the end items to be furnished.

 

51


  2.

Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a business concern that is small, HUBZone small, small disadvantaged, service-disabled veteran-owned small, economically disadvantaged women-owned small, or women-owned small eligible under the WOSB Program in order to obtain a contract to be awarded under the preference programs established pursuant to section 8, 9, 15, 31, and 36 of the Small Business Act or any other provision of Federal law that specifically references section 8(d) for a definition of program eligibility, shall –

 

  (i)

Be punished by imposition of fine, imprisonment, or both;

 

  (ii)

Be subject to administrative remedies, including suspension and debarment; and

 

  (iii)

Be ineligible for participation in programs conducted under the authority of the Act.

FAR 52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)

 

  a.

Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

 

  b.

The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

 

  c.

Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

 

52


PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

 

  1.

Statement of Work, dated September 29, 2015, 18 pages

 

  2.

Invoice/Financing Instructions for Cost-Reimbursement Type Contracts

 

  3.

Invoice Instructions for Fixed-Priced Type Contracts

 

  4.

Sample Invoice Form

 

  5.

Research Patient Care Costs

 

  6.

Report of Government Owned, Contractor Held Property, 1 page.

 

  7.

Form SF-LLL, Disclosure of Lobbying Activities, 2 pages

 

  8.

Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page

 

53


Attachment 1 - Statement of Work (SOW)

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to support this acquisition.

Avita Medical BASE SOW

 

Summary Table

 

CLIN

   WBS1st
Level
Element
  

Title

  

Objectives

0001   

1

  

Project

Management

  

•  Establish project management infrastructure

 

•  Establish EVM systems

 

•  Finalize IMPP

 

•  Technical and financial reporting

   2    Non-Clinical Objectives   

•  Close gaps in non-clinical data required for PMA module 1 of 3, including biocompatibility, human factors, packaging testing to generate ISO design dossier as an FDA-compliant design history file.

 

•  Establish appropriate training for use of ReCell in mass casualty setting.

 

•  Achieve 4-year stability

   3    Clinical Objectives   

•  Complete pivotal trials (-5 and -6 protocols) and clinical study reports for PMA module 3 of 3.

   4   

Regulatory

Objectives

  

•  Fulfill Pre-EUA requirements

 

•  Modular PMA Submission

 

•  Secure Pre-Market Approval (PMA)

   5   

Product

Development for Mass Casualty/VMI

  

•  Gather requirements for Mass Casualty and VMI

 

•  Redesign ReCell packaging and any other subcomponents in order to meet requirements for more efficient VMI and deployment

 

•  Complete V&V

   6    QSR Objectives   

•  Perform QSR Gap remediation (address all gaps identified) for PMA module 2 of 3.

 

•  Scale up manufacturing process for ReCell to support USG acquisition and US Market introduction

 

•  Qualify alternate suppliers, for sustainability

 

0002    7   

Procurement

(Initial)

  

•  Execute acquisition contract

 

•  Establish VMI

 

•  Manage inventory

Overview

Avita’s initial primary objective with the proposed effort is to secure FDA approval for the ReCell device. In order to accomplish this we need (1) a documented design (with documentation and supporting testing -e.g. biocompatibility- done to FDA standards rather than ISO standards), for which the work is done in WBS 2.1.2, 2.1.3, and 2.1.4; (2) an FDA-compliant quality system and documentation of GMP manufacturing: WBS 6.1; and (3) Pivotal Clinical Data: WBS 3.1.

 

Page 1 of 15


The above-mentioned work is delivered to FDA via PMA modules 1, 2 and 3, respectively (WBS 4.2.2). The PMA modules will require organizing and assembling reports into a standardized format, setting context and drawing overall conclusions. In addition to submission of the PMA modules, Avita will also draft (and get FDA-approval of) a Conditions of Approval study protocol (WBS 3.3.1.1, 4.2.2.4.2), and pass through a panel (of experts) review (WBS 4.2.2.5). Avita will need favorable reviews of the PMA modules, CoA protocol approval, and panel review to get the product approved.

Concurrent with the FDA approval process, there is an Emergency Use pathway, activated in the event of a mass casualty, which would enable FDA to authorize use of an investigational (unapproved) product for life-saving measures. There is “pre-emergency” work that can be done to facilitate a future potential Authorization. (WBS 4.1)

Once there is confidence in EUA status or there is PMA approval, base procurement (WBS 7.1.1) is triggered.

There are several other items that are part of the program in order to ensure success in stockpiling, distributing, and using ReCell during an emergency event:

 

  1.

Training of medics for use of ReCell in mass casualty events (WBS 2.1.1).

 

  2.

Increased shelf-life, with a target of up to 4 years (as supported by stability testing) (WBS 2.3)

 

  3.

VMI planning/implementation (WBS 7.2, 7.3, 7.4)

 

  4.

Optimize product packaging more for palletized storage and VMI, (WBS 5)

 

  5.

Qualifying second sources for key components and for product final assembly (i.e. alternative/supplementary sources for enzyme and a supplement/alternative to Parker) (WBS 6.2.2).

CLIN 0001 - Base Period

 

1.0

Program Management

 

  1.1

Internal Project Management

 

WBS# and Title

  

Milestone

  

Deliverable

1.1.5 Integrated Master Project Plan    Upon delivery to and acceptance by BARDA    All required elements of this plan as listed in the RFP

 

  1.1.5

Title: Integrated Master Project Plan

Objective/Description of Work: Avita will compile all necessary materials and finalize all aspects of the project related to preparing the Integrated Master Project Plan. This will include finalizing critical path milestones, Work Breakdown Structure (WBS), and Risk Mitigation Plan. The final deliverable of the IMPP will represent the finalization and approval of all project elements between Avita and BARDA.

 

  Milestones:

 

  1.1.5.1

Critical Path Milestones – The critical path milestones are finalized and submitted, reviewed, and approved by BARDA.

 

  1.1.5.2

Work Breakdown Structure – The WBS is finalized and submitted, reviewed, and approved by BARDA for all project activities.

 

Page 2 of 15


  1.1.5.3

Risk Mitigation Plan/Matrix – Any additional elements of risk are identified and all elements of risk are finalized and submitted, reviewed, and approved by BARDA. Risk management plans for each risk are finalized and submitted, reviewed, and approved by BARDA.

 

  Deliverables:

 

  1.1.5

Integrated Master Project Plan – Containing all required elements as listed in the RFP and/or requested by BARDA.

 

  1.1.5.1

Critical Path Milestones – An updated and finalized critical path milestone document.

 

  1.1.5.2

Work Breakdown Schedule – An updated and finalized WBS document. 1.1.5.3 Risk Mitigation Plan/Matrix – An updated and finalized risk mitigation plan/matrix.

 

  1.2

Contract Management

 

WBS# and Title

  

Milestone

  

Deliverable

1.2.2 Reporting    Upon delivery to and acceptance by BARDA    All required reports as listed in the RFP and requested by BARDA
1.2.3 Meetings    BARDA Kick-Off Meeting    Meeting Presentation Materials

 

  1.2.2

Title: Reporting

Objective/Description of Work: Avita will comply with all reporting requirements as outlined and formatted in the RFP and as requested by BARDA. Reporting will include at a minimum monthly progress reports, annual progress reports, annual invention reports, draft final report, and final report. Additional deliverables such as technology packages, experimental protocols, publication, press releases, security reports, or other reports will be provided to BARDA for review prior to initiation of a corresponding work element, deliverable, or FDA submission.

 

  Milestones:

 

  1.2.2.1

Monthly Progress Report – Delivery to and acceptance by BARDA.

 

  1.2.2.2

Annual Progress Report – Delivery to and acceptance by BARDA.

 

  1.2.2.3

Invention Reports – Delivery to and acceptance by BARDA.

 

  1.2.2.4

Draft Final and Final Progress Reports – Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.2.2.1

Monthly Progress Report – A report detailing the prior month’s activities and activities planned for the following month. Report will be delivered prior to the 15th of the month following the reporting period.

 

  1.2.2.2

Annual Progress Report – A report summarizing the activities of the period of performance and the activities planned for the upcoming period. Report will be delivered prior to the 30th of the month following the reporting period.

 

  1.2.2.3

Annual/Final Invention Report – A report detailing any intellectual property developed as a result of the work performed during each period of performance and the entire contract period. Report will be delivered in conjunction with the annual progress report.

 

  1.2.2.4

Draft Final and Final Progress Report – The Final Progress Report will include a complete summary of all work performed during the entire contract period of performance. A Draft Final Progress Report will be delivered 45 days prior to contract expiration for BARDA review and comments. A Final Progress Report will be delivered prior to 30 days following contract expiration.

 

Page 3 of 15


  1.2.3

Title: Meetings

Objective/Description of Work: Avita and BARDA will engage in regular meetings to coordinate and review project activities. Meetings will be both face-to-face and teleconference/video conference. The first official meeting will be the face-to-face kick-off meeting, followed by status update meetings on a biweekly/monthly basis, ad hoc teleconferences and site visits, and annual meetings to report on the period of performance activities.

 

  Milestones:

 

  1.2.3.1

Kickoff Meeting with BARDA – The contract is awarded and a face-to- face kickoff meeting is conducted within 30 days of award date.

 

  Deliverables:

 

  1.2.3.2

Kickoff Meeting Presentation Materials – Avita will prepare all necessary presentation materials for the kickoff meeting.

 

  1.4

IMS and EVM

 

WBS# and Title

  

Milestone

  

Deliverable

1.4.2 Performance Measurement Baseline    Performance Measurement Baseline Review (PMBR)    All required components for the PMBR
1.4.3 Integrated Master Schedule    PMBR    Integrated Master Schedule
1.4.4 Monthly Earned Value Performance Report    Delivery to and acceptance by BARDA    Monthly Earned Value Performance Report
1.4.5 Supplemental monthly CAP report    Delivery to and acceptance by BARDA    Supplemental monthly CAP report

 

  1.4.2

Title: Performance Measurement Baseline

Objective/Description of Work: The Performance Measurement Baseline will provide a master schedule of deliverables, costs, and milestones in order to completely cover all items in the SOW. All required components will be submitted to BARDA within 90 days of contract award. BARDA and Avita will mutually agree on the budget, schedule and technical plan baselines as a result of the PMBR.

 

  Milestones:

 

  1.4.2

Performance Measurement Baseline Review – The PMBR plan is submitted and reviewed by BARDA.

 

  Deliverables:

 

  1.4.2

Performance Measurement Baseline Review Plan and Required Components – A plan detailing a schedule of deliverables, costs, milestones, and risks that will serve as the basis for measuring project progress.

 

Page 4 of 15


  1.4.3

Title: Integrated Master Schedule (IMS)

Objective/Description of Work: The IMS will be used to monitor performance of the contract. Avita will develop an IMS in a format approved by BARDA in order to track key milestones, Go/No Go decision gates. The IMS will contain baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. Avita will provide a baseline IMS for the PMBR and monthly updates thereafter.

 

  Milestones:

 

  1.4.2

Integrated Master Schedule is approved by BARDA.

Deliverables:

 

  1.4.3

Integrated Master Schedule – Provided for the PMBR and monthly in order to monitor performance of the contract. The IMS shall be provided at the work package level in MS Project file format.

 

  1.4.4

Title: Monthly Earned Value Performance Report

Objective/Description of Work: The Monthly Earned Value Performance Report will be generated from Avita’s EVMS in order to track any project variances against the baseline. The report will contain technical, schedule, and cost status information in order to identify any issues that may impact project progress and/or cost.

 

  Milestones:

 

  1.4.4

Monthly Earned Value Performance Report – Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.4.4

Monthly Earned Value Performance Report – Provided monthly to track project progress according to WBS and EV variance.

 

  1.4.5

Title: Supplemental Monthly CAP Report

Objective/Description of Work: The Supplemental Monthly CAP Report will be generated from Avita’s EVMS and will contain cost information to report on the time phased budget, earned value, and actual costs of work performed. The report will be submitted monthly to BARDA for review.

 

  Milestones:

 

  1.4.5

Supplemental Monthly CAP Report – Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.4.5

Supplemental Monthly CAP Report – Provided monthly to detail time phased budget, earned value, and actual costs of work performed as captured by Avita’s EVM systems.

 

Page 5 of 15


2

Non-Clinical Objectives

 

  2.1

Efficacy and Safet

 

WBS# and Title

  

Milestone

  

Deliverable

2.1.1.1 Updated training resources for mass casualty    Effective training for mass casualty event.    Updated user training documentation
2.1.2 Biocompatibility review    Biocompatibility review complete    Biocompatibility Review Report
2.1.3 Human Factors    FDA requests human factors studies    Human factors studies submitted to FDA
2.1.4 FDA-compliant design documentation    Completion of backup documentation for PMA module 1.    QSR-mandated design control documents and supporting lab test results

 

  2.1.1.1

Title: Updated training resources for mass casualty

Objective/Description of Work: Existing training manuals for use of the ReCell device are designed for a clinical/surgical setting by experienced clinicians. Led by the Director of Education, with support from the Education Specialist, Avita will develop a new training protocol sufficient for a mass casualty event for ReCell to be used by minimally trained personnel that may or may not have burn surgery experience. Target goal will be a one-hour training session to personnel at a trained medic level or higher. New training materials will be submitted to BARDA for review/feedback and then finalized.

Milestones:

 

  2.1.1

Creation of training materials, including video, workshop/online course materials, reference guides, as determined in collaboration with BARDA

Deliverables:

 

  2.1.1.1

Training materials as determined in collaboration with BARDA.

 

  2.1.2

Title: Biocompatibility review complete

Objective/Description of Work: Full biocompatibility is demonstrated for EU and Australia, to ISO standards. The testing work needs to be done to US FDA standards. Results of biocompatibility review will be submitted to BARDA for review/feedback.

Milestones:

 

  2.1.2

Biocompatibility submitted to FDA

Deliverables:

 

  2.1.2

Biocompatibility Review Report draft and final report submitted to BARDA and final report submitted to FDA

 

  2.1.3

Title: Human Factors

Objective/Description of Work: Avita will conduct an evaluation to ensure that the ReCell devices meet usability guidelines when used by the intended user population. Avita will conduct all required studies and submit the results to BARDA for review and feedback. Upon BARDA approval, Avita will submit report to FDA.

 

Page 6 of 15


Milestones:

 

  2.1.3

Requested data/report submitted to FDA

Deliverables:

 

  2.1.3

As requested by FDA, human factors draft and final reports submitted to BARDA and final data and report submitted to FDA

 

  2.1.4

Title: FDA-Compliant Design Documentation

Objective/Description of Work: Avita’s recent gap analysis for PMA module 1 readiness indicates that in addition to biocompatibility testing Avita will need to create an FDA QSR-compliant design control document package, including backup lab test data and reports, including packaging testing. Avita will provide the various reports to BARDA, as requested, for review and approval prior to sending to FDA.

Milestones:

 

  2.1.4.1

Functional Testing Complete

 

  2.1.4.2

Packaging/Shipping Testing Complete

 

  2.1.4.3

EMI/EMC Testing Complete

 

  2.2

Non-clinical data sufficient for PMA module 1 of 1

Deliverables:

 

  2.1.4

QSR-mandated design control documents and supporting lab test results – Avita will generate a design control document package that will meet current FDA requirements, in support of PMA module 1 of 1

 

  2.3

Stability and Review of Extended Shelf Life

 

WBS# and Title

  

Milestone

  

Deliverable

2.3.1 Stability Plan    Expiration limiting components identified and plan developed to extend to 4-year target    Stability Plan
2.3.6 Stability Report (accelerated aging)    Accelerated aging testing results complete    Stability report
2.3.7 Stability report (real- time aging)    Real-time aging testing results complete    Stability report
2.3.8 Review of extended shelf life    New expiry limits determined    Results report submitted to BARDA
2.3.9 Revisions to labeling    Stability extension submission    Shelf life report and revised labeling submitted to FDA

 

  2.3.1

Title: Stability Plan

Objective/Description of Work: Avita will develop a stability plan that will outline the testing necessary to extend the shelf life of the ReCell unit to 4 years in order to minimize product losses due to expiry. Avita will focus on specific expiration-limiting components (enzyme and buffer, RPU, and nozzle). Avita will design and execute on a stability testing plan to verify stability for extension of shelf life. Reports will be submitted to BARDA detailing the shelf life of ReCell units. Labeling will be modified based on new expiries and submitted to FDA to approval.

 

Page 7 of 15


Milestones:

 

  2.3.1

Expiration limiting components are identified and a plan is developed to extend ReCell unit to a target of 4-year expiry.

Deliverables:

 

  2.3.1

Stability plan outlining all necessary real-time and accelerated aging testing required to justify expiry.

 

  2.3.6

Title: Stability Report (accelerated aging)

Objective/Description of Work: Following accelerated aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.6

Stability testing results complete.

Deliverables:

 

  2.3.6

Stability report detailing product performance for ReCell components after aging

 

  2.3.7

Title: Stability Report (real-time aging)

Objective/Description of Work: Following real-time aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.7

Stability testing results complete.

Deliverables:

 

  2.3.7

Stability report detailing aged performance for ReCell components

 

  2.3.8

Title: Review of extended shelf life

Objective/Description of Work: Avita will prepare a report for BARDA detailing the changes product shelf life. Avita will report on the plan for accordingly revised product labeling to be submitted to FDA.

Milestones:

 

  2.3.8

Delivery of report of extended shelf life

Deliverables:

 

  2.3.8

Shelf life report delivered to BARDA for review, followed by a report detailing plans for FDA submission, and implications for the VMI.

 

Page 8 of 15


  2.3.9

Title: Revisions to labeling

Objective/Description of Work: Avita will revised the product labeling to reflect new shelf life parameters, and will submit to FDA.

Milestones:

 

  2.3.9

FDA approval of revised product labeling

Deliverables:

 

  2.3.9

New product labeling and FDA submission for review/approval of new product labeling.

 

3

Clinical

 

  3.1

Pivotal Clinical Trials

 

WBS# and Title

  

Milestone

  

Deliverable

3.1.1.4 Clinical Study Report    CTP001-5 Clinical Study Report (CSR), review complete    CTP001-5 Clinical Study Report (CSR), review/submit to FDA
3.1.2.6.1 Statistical Analysis (9mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.2 Clinical Study Report (9mo)    CTP001-6 Initial (9-months) CSR complete    CTP001-6 Initial (9-months) CSR, review (PMA module 3 of 3)
3.1.2.6.4 Statistical Analysis (12mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.5 Clinical Study Report (12mo)    CTP001-6 Final (12-months) CSR complete    CTP001-6 Final (12-months) CSR, review

 

  3.1.2.8

Title: Final CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pivotal Clinical Trials encompass two ongoing clinical protocols: CTP001-5 (deep partial-thickness) and CTP001-6 (mixed depth including full-thickness). Both studies show definitive closure using less donor skin with ReCell as compared to standard care, and are also looking at long-term scar outcomes. The clinical study report (CSR) from CTP001-6 is the primary component of PMA module 3 of 3. All CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.1.1.1

Last subject last visit for CTP001-5 (complete)

 

  3.1.1.4

Clinical Study Report complete for CTP001-5

 

  3.1.2.1.1

FDA Statistical Analysis Plan submitted and approved by FDA for CTP001-6 (complete)

 

Page 9 of 15


  3.1.2.3.2

Last subject last visit for CTP001-6

 

  3.1.2.6.4

CRO completes 9-month statistical analysis for PMA module 3 of 3.

 

  3.1.2.8

Final CSR review complete and data is determined to be sufficient for FDA submission

 

  Deliverables:

 

  3.1.1.4

CTP001-5 Clinical Study Report (CSR)

 

  3.1.2.6.1

CTP001-6 9-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.2

CTP001-6 Initial (9-months) CSR (for PMA module 3 of 3)

 

  3.1.2.6.4

CTP001-6 12-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.5

CTP001-6 Final (12-months) CSR

 

4

Regulatory

 

  4.1

Pre-Emergency Use Authorization

WBS# and Title

  

Milestone

  

Deliverable

4.1 Pre-Emergency Use Authorization    Avita completes all submissions needed for EUA    All data requested by BARDA to obtain pre-EUA

 

  4.1

Title: Pre-Emergency Use Authorization

Objective/Description of Work: Avita will support BARDA/HHS in obtaining a Pre-Emergency Use Authorization for the ReCell device. All required studies, reviews, reports, and analyses will be provided as requested.

 

  Milestones:

 

  4.1

Avita completes all submissions needed for EUA

 

  Deliverables:

 

  4.1

Submission to BARDA/HHS of all required materials needed for Pre-EUA.

 

  4.2

Premarket Approval (PMA)

WBS# and Title

  

Milestone

  

Deliverable

4.2.2.1.4 Module 1 Submission    Module 1 package assembled    Module 1 package to FDA
4.2.2.2.4 Module 2 Submission    Module 2 package assembled    Module 2 package to FDA
4.2.2.3.4 Module 3 Submission    Module 3 package assembled    Module 3 package to FDA
4.2.2.5.3 Create action plan to address panel recommendations    FDA Panel Meeting    Action Plan

 

  4.2.2.1.4

Title: Module 1 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package with modular submissions for FDA review and approval. The PMA package will consist of three PMA modules. Module 1 will focus on non-clinical data.

 

Page 10 of 15


Milestones:

 

  4.2.2.1.4

Module 1 package assembled

Deliverables:

 

  4.2.2.1.4

Module 1 submission to FDA – Module 1 includes biocompatibility, human factors, shipping/packaging validation, EMI/EMC, and all other required non-clinical data.

 

  4.2.2.2.4

Title: Module 2 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 2 will focus on manufacturing data.

Milestones:

 

  4.2.2.2.4

Module 2 package assembled

Deliverables:

 

  4.2.2.2.4

Module 2 submission to FDA – Submission will include the principles of operation, quality system and manufacturing documentation, sterilization, shelf-life information, and packaging information.

 

  4.2.2.3.4

Title: Module 3 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 3 will focus on clinical data. Module 3 will be submitted to BARDA for review and approval, followed by submission to FDA.

Milestone:

 

  4.2.2.3.4

Module 3 package assembled and approved by BARDA

Deliverables:

 

  4.2.2.3.4

Module 3 submission to FDA – Submission will include the CTP001-6 clinical data labels and manuals, draft post-marketing plan (CoA study protocol) and bibliography.

 

5

Product Development for mass casualty/VMI

 

  5.1

Requirement Gathering, 5.2 Product Design, 5.3 Systems Requirements and Design Review, and 5.4 CDC Quality Agreement

WBS# and Title

  

Milestone

  

Deliverable

5.3 Systems Requirements (VMI optimization) and Design Review    Review of VMI optimized product design package complete    Product optimized for VMI Design Package
5.4 CDC Quality Agreement    Executed CDC Quality Agreement    CDC Quality Agreement

 

Page 11 of 15


5.3, 5.4 Title: Systems Requirements (VMI optimization) and Design Review

Objective/Description of Work: In order to develop a product ready for manufacturing and stockpiling, Avita will work with BARDA to first gather the requirements for DFM/DFA, inventory management and any other requirements. Based on the requirements, Avita will initiate Product Design to all ensure the product will meet specifications. This includes design and review for any changed or affected part: Components, Subassembly, Product System, and Packaging Design. Document package will be sent to BARDA for review. Avita will work with CDC to establish a quality agreement, if required.

Milestones:

 

  5.1

Requirements document compiled from BARDA

 

  5.2.1.2

Component Design Review complete

 

  5.2.2.2

Subassembly Design Review complete

 

  5.2.3.2

Product System Design Review complete

 

  5.2.4.2

Packaging Design Review complete

 

  5.3

Full systems requirements and design review complete and approved by BARDA

 

  5.4

If required, establish quality agreement with CDC for supporting VMI

Deliverables:

 

  5.3

System Requirements and Design Review – A system requirements and design review report will be submitted to BARDA containing the requirements and the design changes made to meet those requirements.

 

  5.4

Agreed upon CDC quality agreement for supporting VMI (if required)

 

  5.5

Verification and Validation

 

WBS# and Title

  

Milestone

  

Deliverable

5.5 Verification and Validation Report    V&V verifies product meets specifications and requirements    V&V Report

 

  5.5

Title: Verification and Validation Report

Objective/Description of Work: Verification & Validation are used to verify that the product meets the specifications and requirements and address the intended purpose. Verification demonstrates that the product meets specification and Validation demonstrates fitness of use for the intended purpose. Once V&V results are positive, the product is ready to release to manufacturing. Avita will submit a report to BARDA detailing the results of the V&V analysis.

Milestones:

 

  5.5

Testing and analysis indicate that the product meets specification and intended purpose.

Deliverables:

 

  5.5

V&V Report - Avita will submit a report to BARDA detailing the results of the V&V analysis.

 

Page 12 of 15


6

QSR

 

  6.1

Quality System Preparedness

 

WBS# and Title

  

Milestone

  

Deliverable

6.1.3 3rd Party Audit    Audit completed    QSR Audit Report

 

  6.1.3

Title: 3rd Party Audit

Objective/Description of Work: The US FDA Quality System Regulation (QSR) describes the environment under which medical device firms must operate. This task involves preparing the Avita quality systems for FDA review and inspection, and verifying compliance with FDA requirements. Avita hired an external 3rd party auditor to complete a QSR gap analysis. Following the audit a gap assessment was prepared and presented to Avita from the 3rd party auditor. Avita will develop a Gap Corrective Action plan to address any gaps identified. This will support PMA submission. Once the corrective action plan has been implemented and changes are in place a mock audit will be performed by a 3rd party auditor in preparation for an expected FDA inspection during PMA review.

Milestones:

 

  6.1.1

Gap Assessment

 

  6.1.2

Gap corrective action performed and all systems brought into compliance

 

  6.1.3

Mock QSR audit

Deliverables:

 

  6.1.3

QSR 3rd Party Audit Report - Avita will submit a report to BARDA detailing the results of the final QSR audit.

 

  6.2

Commercial Manufacturin

 

WBS# and Title

  

Milestone

  

Deliverable

6.2.1 Commercialization Plan and Gap Analysis    Completion of commercialization plans    Final Commercialization Plan
6.2.2.4 Validation Report    IQ/OQ/PQ process validations complete    Validation Report

 

  6.2.1

Title: Commercialization Plan and Gap Analysis

Objective/Description of Work: Perform a gap analysis to assess commercialization readiness and draft a commercialization plan in support of market entry. Tasks include, as necessary, establishing SKU#, Supply chain and vendor qualifications, raw material inventory, sterilization, packaging, and labeling, and lot release.

Milestones:

 

  6.2.1.1

Commercialization Gap Assessment completed

 

  6.2.1.2

Commercialization Plan Draft created, reviewed with BARDA

 

  6.2.1.3

Commercialization Plan finalized.

 

Page 13 of 15


Deliverables:

 

  6.2.1.1

Commercialization Gap Assessment Report

 

  6.2.1.2

Commercialization Plan draft and final versions reviewed and submitted to BARDA.

 

  6.2.2.4

Title: Validation Report

Objective/Description of Work: Process validation involves the collection and evaluation of data from the processes used to produce the product. Avita’s commercial manufacturer will lead the effort in manufacturing, under close supervision and collaboration with Avita. Sterile packaging will be a primary focus of the validation effort to ensure repeatable package integrity and valid sterilization processes. Process validations will include IQ/OQ/PQ and final validation. Avita will present a final report detailing the results of the validation analysis.

Milestones:

 

  6.2.2.1

IQ, Installation Qualification complete

 

  6.2.2.2

OQ, Operation Qualification complete

 

  6.2.2.3

PQ, Process Qualification complete

Deliverables:

 

  6.2.2.4

Validation Report - Avita will submit a report to BARDA detailing the results of the process validation analysis.

CLIN 0002 – Base Period

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.1.2 Product Manufacturing    Order Received    Initial Product
7.1.1.3 Deploy product to VMI sites    Product shipped to sites    Product deployed

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: Upon authorization from BARDA, Avita will cause the production and delivery of ReCell devices. Upon receiving the order Avita will authorize the manufacturer to procure supplies for the manufacture of the devices and preparing designated inventory locations.

Milestones:

 

  7.1.1.1

Order Received

 

  7.1.1.2

Delivery of specified quantity of units to VMI.

Deliverables:

 

  7.1.1.2

Initial Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices.

 

Page 14 of 15


  7.1.1.3

Product integrated into VMI and available for deployment

 

  7.2

VMI Remote inventory management system

 

WBS# and Title

  

Milestone

  

Deliverable

7.2.1 - Gather VMI Requirements    All VMI requirements agreed upon with BARDA    VMI Requirements Document

 

  7.2.1

Title: Gather VMI Requirements

Objective/Description of Work: Avita will work with USG to identify all VMI requirements, and prepare a document detailing the requirements.

Milestones:

 

  7.2.1

All VMI requirements agreed upon with BARDA

Deliverables:

 

  7.2.1

VMI Requirements Document – Report detailing the agreed upon requirements for VMI.

 

  7.3

Sustainment/Stockpile Management

 

WBS# and Title

  

Milestone

  

Deliverable

7.4.1 Inventory Management    Quarterly inventory reports    Inventory Management Report

 

  7.3.1

Title: Inventory Management

Objective/Description of Work: Inventory management encompasses activities that occur after the inventory is on site and the inventory system is in operation. The purpose is to ensure ongoing compliance with the stockpiling requirements, and manage replenishment to ensure unit availability in emergency situations. Site environments will continue to be monitored through the lifetime of the contract for compliance with environmental requirements, and inventory controls will be followed. Site performance will be monitored periodically, supplemented by BARDA site visits. Plans will be executed to replenish expiring goods and units will be reworked as needed to maintain currency. Avita will present to BARDA Inventory Management Reports detailing the status and activities at all VMI locations at a frequency determined appropriate by BARDA and Avita.

Milestones:

 

  7.3.1

Quarterly inventory reports

Deliverables:

 

  7.3.1

Inventory Management Report

 

Page 15 of 15


Avita Medical OPTION SOW

 

Summary Table

 

CLIN

  

WBS 1st Level
Element

  

Title

  

Objectives

0003    3    CoA Study   

•  Complete Post-Approval (conditions of approval) study, as required by FDA

0004    3, 4    Pediatric Studies   

•  Complete pediatric clinical trials per FDA requirements and BARDA guidance

0005    7   

Procurement

(Surge)

  

•  Execute acquisition contract

 

•  Expand VMI as necessary

Overview

Avita has defined three option periods covering the Conditions of Approval (CoA) study after FDA approval of the ReCell Device (CLIN 0003), a Pediatric study to expand the indications for ReCell for a broader pediatric demographic, if necessary, for ReCell (CLIN 0004), and for the procurement of additional ReCell devices beyond the initial acquisition (CLIN0005). Note: Updated SOW(s) will be provided to BARDA based on FDA feedback to support the execution of each CLIN. The accompanying budget(s) will also be updated to align with the revised SOW(s).

The purpose of the CoA, CLIN 0003, is to provide longer-term evaluation of the ReCell device after FDA approval, in order to track and confirm that any post-market commitments are addressed by Avita.

The purpose of the Pediatric Study, CLIN 0004, is to expand the approved range of patients for ReCell, specifically for pediatric patients, beyond those originally approved during the PMA process. The specific study design and objectives will be based on the PMA approval outcomes as well as consultation with BARDA, and will be intended to expand the range of patients able to be treated by ReCell.

Surge acquisition, CLIN 0005, will support additional acquisition of ReCell devices by BARDA, CDC, or other stakeholders.

CLIN 0003 – Option – CoA Study

 

3

Clinical

 

  3.3

Post approval (Condition of Approval Stud

 

WBS# and Title

  

Milestone

  

Deliverable

3.3.1.2 Submit protocol to BARDA for review    Protocol developed    Study Protocol
3.3.6.1 Statistical analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.3.6.2 Clinical study report    CSR complete    CSR, review/submit to FDA

 

Page 1 of 4


  3.3.6.4

Title: Final CoA CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Post approval (COA study) will be carried out if an additional study is required by FDA as a condition of PMA approval. If a COA study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.3.1.1

Protocol developed

 

  3.3.2.2

Last subject last visit

 

  3.3.6.1

CRO completes statistical analysis

 

  3.3.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.3.1.2

Study Protocol submitted to BARDA

 

  3.3.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.3.6.2

CSR, review/submit to FDA

CLIN 0004 – Option – Pediatric Study

 

3

Clinical

 

  3.2

Pediatric Study for Expanded Labelin

 

WBS# and Title

  

Milestone

  

Deliverable

3.2.1.2 Submit protocol to BARDA for review    Protocol developed    Study protocol
3.2.6.1 Statistical Analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.2.6.2 Clinical Study Report    CSR complete    CSR, review/submit to FDA

 

  3.2.8

Title: Final Pediatric CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pediatric study for expanded labeling will be carried out if requested by the BARDA to study younger children. If a pediatric study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.2.1.1

Protocol developed

 

  3.2.3.1

Last subject last visit

 

  3.2.6.1

CRO completes statistical analysis

 

Page 2 of 4


  3.2.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.2.1.2

Clinical Study Protocol

 

  3.2.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.2.6.2

Clinical Study Report (CSR)

 

4

Regulatory

 

  4.2.5

Pediatric Indication

 

WBS# and Title

  

Milestone

  

Deliverable

4.2.5.1 Pediatric IDE    FDA approval of pediatric IDE    Pediatric IDE application
4.2.5.3 Pediatric PMA supplement    FDA approval of expanded indication for pediatrics    Submission for Pediatric label expansion

 

  4.2.5

Title: Pediatric Indication

Objective/Description of Work: Avita will make the regulatory filings with FDA for both a pediatric IDE clinical trial and a PMA supplement for expansion of labeling for pediatric indication.

Milestones:

 

  4.2.5.2

FDA approval of pediatric IDE study

 

  4.2.5.4

FDA approval of pediatric indication

Deliverables:

 

  4.1.5.1

Pediatric IDE application.

 

  4.2.5.3

PMA supplement for pediatric indication

CLIN 0005 – Procurement (Surge)

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received    Additional product to meet surge capacity

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

 

Page 3 of 4


Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

 

Page 4 of 4


ATTACHMENT #2

INVOICE/FINANCING REQUEST INSTRUCTIONS - FOR COST-REIMBURSEMENT TYPE CONTRACTS

Format: Payment requests shall be submitted on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.

Number of Copies: Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

Frequency: Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Officer.

Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by pre-contract cost provisions.

Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs.

Contractor’s Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.

Currency: All BARDA contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

Costs Requiring Prior Approval: Costs requiring the Contracting Officer’s approval, including those set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request.

Invoice/Financing Request Identification: Each payment request shall be identified as either:

 

(a)

Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract performance period.

 

(b)

Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.

 

Page 1 of 4


(c)

Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).

Preparation and Itemization of the Invoice/Financing Request: The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.

 

(a)

Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(b)

Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).

 

(c)

Invoice/Financing Request Number: Insert the appropriate serial number of the payment request.

 

(d)

Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared.

 

(e)

Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable).

 

(f)

Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order.

 

(g)

Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.

 

(h)

Total Fixed-Fee: Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract.

 

(i)

Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(j)

Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(k)

Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(l)

Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

 

Page 2 of 4


(m)

Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(n)

Amount Billed - Cumulative: Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(o)

Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

 

  (1)

Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.

 

  (2)

Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.

 

  (3)

Accountable Personal Property: Include any property having a unit acquisition cost of $5,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property)(e.g. personal computers). Note this is not permitted for reimbursement without pre-authorization from the CO.

On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. Include reference to the following (as applicable):

 

   

Item number for the specific piece of equipment listed in the Property Schedule, and

 

   

COA number, if the equipment is not covered by the Property Schedule.

The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract.

 

  (4)

Materials and Supplies: Include all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required.

 

  (5)

Premium Pay: List remuneration in excess of the basic hourly rate.

 

  (6)

Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.

 

  (7)

Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

 

Page 3 of 4


  (8)

Subcontract Costs: List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes, etc.).

 

  (9)

Other: Include all other direct costs not fitting into an aforementioned category. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.

 

(p)

Cost of Money (COM): Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if applicable.

 

(q)

Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.

 

(r)

Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.

 

(s)

Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.

 

(t)

Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.

 

(u)

Grand Totals

 

(v)

Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:

“I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.”

**Note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31.

 

Page 4 of 4


ATTACHMENT #3

INVOICE/FINANCING REQUEST INSTRUCTIONS FOR FIXED PRICE TYPE CONTRACTS

General The Contractor shall submit vouchers or invoices as prescribed herein.

Format Standard Form l034, Public Voucher for Purchases and Services Other Than Personal, and Standard Form l035, Public Voucher for Purchases and Services Other than Personal—Continuation Sheet, and the payee’s letterhead or self-designed form should be used to submit claims for reimbursement.

Number of Copies: As indicated in the contract.

Frequency Invoices submitted in accordance with the Payment Clause shall be submitted monthly upon delivery of goods or services unless otherwise authorized by the Contracting Officer.

Preparation and Itemization of the Invoice The invoice shall be prepared as follows:

(a) Designated Billing Office and address:

HHS/ASPR/BARDA

330 Independence Ave, Room G640

Washington DC 20201

ATTN: Contracting Officer

(b) Invoice Number

(c) Date of Invoice

(d) Contract number and date

(e) Payee’s name and address. Show the Contractor’s name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the Contractor, or a different payee has been designated, then insert the name and address of the payee instead of the Contractor.

(f) Description of goods or services, quantity, unit price, (where appropriate), and total amount.

(g) Charges for freight or express shipments other than F.O.B. destination. (If shipped by freight or express and charges are more than $25, attach prepaid bill.)

(h) Equipment - If there is a contract clause authorizing the purchase of any item of equipment, the final invoice must contain a statement indicating that no item of equipment was purchased or include a completed form HHS-565, Report of Capitalized Nonexpendable Equipment.

Currency: Where payments are made in a currency other than United States dollars, billings on the contract shall be expressed, and payment by the United States Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

 

Page 1 of 1


ATTACHMENT #4 - SAMPLE INVOICE FORM

Company Name

 

Designated Billing Office Name and Address:

 

DHHS/OS/ASPR/AMCG

Attn: Contracting Officer

200 C St., S.W.

 

Washington, D.C. 20201

 

Contractor’s Address and Contact Information:

 

POC: Name of accountant or COO or signatory authority for invoice

Title:

Phone:

E-Mail:

 

TIN:

DUNS #:

  

Invoice/Finance Number:

 

Date Invoice Prepared:

 

Contract No. and Title:

 

Effective Date & Period of Performance:

 

Total Estimated Cost of Order:

 

Office of Acquisitions:

 

Contracting Officer (insert name here)

Office of Acquisitions Management, Contracts, and Grants (AMCG)

 

Central Point of Distribution:

This invoice represents reimbursable costs for the period from

 

Expenditure Category

             Amount Billed         
   Current      Cumulative      Contract Value  

Direct Costs:

            

Direct Labor

            

Fringe Benefits                  

    0.00           

Total Labor Costs:

            

Overhead                                 

    0.00           

Travel

            

Subcontracts

            

Consultant Fees

            

Materials and Supplies

            

Other

            

Total Direct Costs

            

G&A Rate                 

    0.00           

Subtotal:

            

Fixed Fee                 

    0.0             

Total Amount Claimed

            

Adjustments

            

Grand Total

       $ —          

I Certify that all payments are for appropriate purposes and in accordance with the contract.

 

Name/signature of signatory authority for invoicing

 

Page 1 of 1


ATTACHMENT #5

RESEARCH PATIENT CARE COSTS

 

(a)

Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract.

 

(b)

Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative.

 

(c)

Prior to submitting an invoice for patient care costs under this contract, the Contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care.

 

(d)

The Contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement.

 

(e)

Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract.

 

Page 1 of 1


Attachment 6

 

REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY

CONTRACTOR:

 

CONTRACT NUMBER:

ADDRESS:

 

REPORT DATE:

ADDRESS1:

 

ADDRESS2:

 

FISCAL YEAR:

CITY:

 

STATE:

ZIP:

 

 

     BEGINNING OF
PERIOD
     ADJUSTMENTS      END OF PERIOD  

CLASSIFICATION

   #ITEMS      VALUE      GFP ADDED      CAP ADDED      DELETIONS      #ITEMS      VALUE  

LAND >=$25K

                    

LAND <$25K

                    

OTHER REAL >=$25K

                    

OTHER REAL <$25K

                    

PROPERTY UNDER CONST >=$25K

                    

PROPERTY UNDER CONST <$25K

                    

PLANT EQUIP >=$25K

                    

PLANT EQUIP <$25K

                    

SPECIAL TOOLING >=$25K

                    

SPECIAL TOOLING <$25K

                    

SPECIAL TEST EQUIP >=$25K

                    

SPECIAL TEST EQUIP <$25K

                    

AGENCY PECULIAR >=$25K

                    

AGENCY PECULIAR <$25K

                    

MATERIAL >=$25K (CUMULATIVE)

              

PROPERTY UNDER MFR >=$25K

              

PROPERTY UNDER MFR <$25K

              

 

SIGNED BY:

       

SIGNATURE

 

 

  

DATE SIGNED:

  

 

NAME PRINTED

 

 

  

Email

  

 

TITLE

 

 

  

TELEPHONE

  

 

Report of Government Owned, Contractor Held Property (Rev 10/2014)

 

Page 1 of 1


Attachment 7

DISCLOSURE OF LOBBYING ACTIVITIES    Approved by OMB

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352    0348-0046 (See reverse for public burden disclosure.)

 

1. Type of Federal Action:

a. contract

b. grant

c. cooperative agreement

d. loan

e. loan guarantee

f. loan insurance

 

2. Status of Federal Action:

a. bid/offer/application

        b. initial award

c. post-award

 

3. Report Type:

a. initial filing

b. material change

      For Material Change Only:

year              quarter             

date of last report             

 

4. Name and Address of Reporting Entity:

 Prime                              Subawardee

                                             Tier ______, if known:

 

Congressional District, if known:

 

5. If Reporting Entity in No. 4 is a Subawardee, Enter

Name and Address of Prime:

 

 

 

Congressional District, if known:

6. Federal Department/Agency:  

7. Federal Program Name/Description:

 

 

CFDA Number, if applicable:                    

8. Federal Action Number, if known:  

9. Award Amount, if known:

$                        

10.a. Name and Address of Lobbying Registrant

      (if individual, last name, first name, MI):

 

b.  Individuals Performing Services (including address if different from No. 10a)

     (last name, first name, MI):

11.  Information requested through this form is authorized by title 31 U.S.C. section 1352. This disclosure of lobbying activities is a material representation of fact upon which reliance was placed by the tier above when this transaction was made or entered into. This disclosure is required pursuant to 31 U.S.C. 1352. This information will be available for public inspection. Any person who fails to file the required disclosure shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

 

Signature:                                                                                  

Print Name:                                                                                  

Title:                                                                                           

Telephone No.:                                      Date:                         

Federal Use Only:  

                                                 Authorized for Local Reproduction

                                                 Standard Form LLL (Rev. 7-97)

 

PRINT

 

Page 1 of 1


INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

This disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is required for each payment or agreementto make payment to any lobbying entity for influencing or attempting to influence an officer or employeeof any agency, a Member of Congress, an officer or employee of Congress, or an employeeof a Memberof Congress in connection with a covered Federal action. Complete all items that applyfor both the initial filing and material change report. Refer to the implementing guidance published by the Office of Management and Budget for additional information.

 

  1.

Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

 

  2.

Identify the status of the covered Federal action.

 

  3.

Identify the appropriate classification of this report. If this is a followup report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.

 

  4.

Enter the full name, address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.

 

  5.

If the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address, city, State and zip code of the prime Federal recipient. Include Congressional District, if known.

 

  6.

Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department of Transportation, United States Coast Guard.

 

  7.

Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.

 

  8.

Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.”

 

  9.

For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.

 

  10.

(a) Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.

 

  (b)

Enter the full names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name, First Name, and Middle Initial (MI).

 

  11.

The certifying official shall sign and date the form, print his/her name, title, and telephone number.

 

According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503.

 

Page 1 of 1


Cumulative Inclusion Enrollment Report

This report format should NOT be used for collecting data from study participants.

 

Study Title:   

 

Comments:   

 

 

Racial Categories

   Ethnic Categories      Total  
   Not Hispanic or Latino      Hispanic or Latino      Unknown/Not Reported
Ethnicity
 
   Female      Male      Unknown/
Not
Reported
     Female      Male      Unknown/
Not
Reported
     Female      Male      Unknown/
Not
Reported
 

American Indian/Alaska Native

                             

Asian

                             

Native Hawaiian or Other Pacific Islander

                             

Black or African American

                             

White

                             

More Than One Race

                             

Unknown or Not Reported

                             
Total                              

 

PHS 398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015)   Page            

OMB No. 0925-0001/0002

Cumulative Inclusion Enrollment Report

 

 

Page 1 of 1

EX-4.5

Exhibit 4.5

 

LOGO

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. Double asterisks denote omissions.    AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 4 2. AMENDMENT/MODIFICATION NO. 0002 3. EFFECTIVE DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. OS176812 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE ASPR–BARDA 7. ADMINISTERED BY (If other than item 6) CODE ASPR–BARDA ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) AVITA MEDICAL AMERICAS, LLC 1476585 AVITA MEDICAL AMERICAS, LLC 92 28159 Avenue Stanford Suite 220 Valencia CA 91355 (x) 9A. AMENDMENT OF SOLICITATION NO.    9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. HHS0100201500028C    10B. DATED (SEE ITEM 13) 09/29/2015 CODE 1476585 FACILITY CODE    11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS â–¡ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers â–¡ is extended.    â–¡ is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing Items 8 and 15, and returning _______________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) Net Increase: $24,317,466.00 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X D. OTHER (Specify type of modification and authority) FAR 52.243-2 Changes-Cost Reimbursement E. IMPORTANT: Contractor ☐ is not. ☒ is required to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Tax ID Number: 20-2578762 DUNS Number: 026723570 To modify ARTICLES B.2. BASE PERIOD, C.1. STATEMENT OF WORK, G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR), G.3 KEY PERSONNEL, G.4. INVOICE SUBMISSION, and section j List of Attachments. The COR is now [**]. The previous COR was [**]. Funds Obligated Prior to this Modification: $16,901,414 Continued . . . Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) Timothy J. Rooney, CFO 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Christopher Scott 15B. CONTRACTOR/OFFEROR                /s/ Timothy J. Rooney (Signature of person authorized to sign) 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA     /s/ Christopher Scott (Signature of Contracting Officer) 16C. DATE SIGNED    6/24/16 NSN 7540-01-152-8070 Previous Edition Unusable STANDARD FORM 30 (REV. 10-83) Prescribed by GSA FAR (48 CFR) 53.243

 

1


CONTINUATION SHEET   

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHS0100201500028C/0002

   PAGE
2
   OF
4

NAME OF OFFEROR OR CONTRACTOR

AVITA MEDICAL AMERICAS, LLC 1476585

 

ITEM NO.

(A)

  

SUPPLIES/SERVICES

(B)

   QUANTITY
(C)
   UNIT
(D)
   UNIT PRICE
(E)
   AMOUNT
(F)
  

Funds Obligated with mod #02: [**]

 

Total Funds Obligated to Date : [**]

PSC Code: 6505

 

Expiration date: September 28, 2020 (Unchanged)

 

Delivery: 06/24/2016

Delivery Location Code: HHS/OS/ASPR

HHS/OS/ASPR

200 C St SW

WASHINGTON DC 20201 US

 

Appr. Yr.: 2016 CAN: 1992016 Object Class: 25103

FOB: Destination

           
4   

Period of Performance: [**]/2015 to [**]/2020

 

Add Item 9 as follows:

 

ASPR-16-01488 — CLINOOOlA Compassionate use, continued access to patients, and mock audit

POP: [**]/2016 – [**]/2020

Obligated Amount: [**]

            7,958,654.00

 

NSN 7540-01-152-8070     

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110


ARTICLE B.2. BASE PERIOD is hereby modified as follows:

 

CLIN

  

Period of

Performance

  

Supplies/ Services

  

Total Est.
Cost

  

Fixed Fee
(7%)

  

Total Cost
Plus Fixed

Fee

COST REIMBURSEMENT

0001

(Base)

   [**] /2015 – [**] /2020    Licensure, approval and clearance of product through the FDA    [**]    [**]    [**]

0001A

   [**] /2016 – [**] /2020    Compassionate use, continued access to patients, and mock audit    [**]    [**]    [**]
FIRM FIXED PRICED

CLIN

  

Period of

Performance

  

Supplies/ Services

  

Units (# of
Product)

  

Unit Price
($)

  

Total ($)

0002

   [**]/2015 – [**]/2020    Initial Purchase, storage, and delivery of product    5614    [**]    [**]

Total CLINS 1&2

   [**]/2015 – [**]/2020    See Above Descriptions         

$24,860,078

(Funded)

ARTICLE C.1. STATEMENT OF WORK is hereby modified as follows:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated June 24, 2016 set forth in SECTION J—List of Attachments, attached hereto and made a part of the contract.

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR) is hereby modified as follows:

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

[**]

Contracting Officer’s Representative

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

[**]

[**]

Mailing Address:

200 C Street

Washington, D.C. 20024

ARTICLE G.3. KEY PERSONNEL is hereby modified as follows:

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the


Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individuals are considered to be essential to the work being performed hereunder:

 

Name

  

Title

[**]    [**]
[**]    [**]
[**]    [**]
[**]    [**]

ARTICLE G.4. INVOICE SUBMISSION paragraph g is hereby added as follows:

 

  g.

Invoices shall be delivered electronically to the Contracting Officer (CO), the Contracting Officer’s Representative (COR), PSC, and e-Room electronically. Unless otherwise specified by the Contracting Officer, all deliverables, invoices, and reports furnished to the Government under the resultant contract shall be addressed as follows:

 

[**]

Contracting Officer

HHS/ASPR/AMCG

200 C Street, S.W.

Washington, DC 20024

Email: [**]

  

[**]

Contracting Officer Representative

HHS/ASPR/BARDA

200 C Street, S.W.

Washington, DC 20024

Email: [**]

  

Email invoices to:

 

PSC Invoices@psc.hhs.qov

 

e-Room

SECTION J — LIST OF ATTACHMENTS: Attachment 1 is hereby modified as follows:

 

  1.

Statement of Work, dated June 24, 2016, 29 pages

All other terms and conditions of this contract remain unchanged.

End of Modification #2


Avita Medical SOW

Advance Understandings

 

The following scope of work is submitted by Avita Medical Americas LLC in compliance with the advanced understandings listed in ARTICLE B of this contract, including invoicing, publications and press releases, protection of human subjects, communication with BARDA, export control, manufacturing standards, contact prohibitions, subcontracting, data handling, confidentiality, compensation, and security reporting.

Avita Medical BASE SOW

 

Summary Table

 

CLIN

  

WBS 15t
Level
Element

  

Title

  

Objectives

0001/0001A    1   

Project

Management

  

•  Establish project management infrastructure

 

•  Establish EVM systems

 

•  Finalize IMPP

 

•  Technical and financial reporting

 

   2    Non-Clinical Objectives   

•  Close gaps in non-clinical data required for PMA module 1 of 3, including biocompatibility, human factors, packaging testing to generate ISO design dossier as an FDA-compliant design history file.

 

•  Establish appropriate training for use of ReCell in mass casualty setting.

 

•  Achieve 4-year stability

 

•  Expand Compassionate Use IDE 15945 (0001A)

 

•  Extend Continued Access IDE 13053 (0001A)

 

•  Incorporate Reimbursement Methods (0001A)

 

•  Model the Economic Benefits of Medical Countermeasures (0001A)

 

   3    Clinical Objectives   

•  Complete pivotal trials (-5 and -6 protocols) and clinical study reports for PMA module 3 of 3.

   4    Regulatory Objectives   

•  Fulfill Pre-EIJA requirements

 

•  Modular PMA Submission

 

•  Secure Pre-Market Approval (PMA)

 

•  BIMO Mock Audit (0001A)

 

•  Enhanced in-house support of the PMA Pathway (0001A)

 

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CLIN

  

WBS 15t
Level
Element

  

Title

  

Objectives

   5    Product Development for Mass Casualty/VMI   

•  Gather requirements for Mass Casualty and VMI

 

•  Redesign ReCell packaging and any other subcomponents in order to meet requirements for more efficient VMI and deployment

 

•  Complete V&V

 

   6    QSR Objectives   

•  Perform QSR Gap remediation (address all gaps identified) for PMA module 2 of 3.

 

•  Scale up manufacturing process for ReCell to support USG acquisition and US Market introduction

 

•  Qualify alternate suppliers, for sustainability

 

0002    7   

Procurement

(Initial)

  

•  Execute acquisition contract

 

•  Establish VMI

 

•  Manage inventory

CLIN 0001 Overview

Avita’s initial primary objective with the proposed effort is to secure FDA approval for the ReCell device. In order to accomplish this we need (1) a documented design (with documentation and supporting testing -e.g. biocompatibility- done to FDA standards rather than ISO standards), for which the work is done in WBS 2.1.2, 2.1.3, and 2.1.4; (2) an FDA-compliant quality system and documentation of GMP manufacturing: WBS 6.1; and (3) Pivotal Clinical Data: WBS 3.1.

The above-mentioned work is delivered to FDA via PMA modules 1, 2 and 3, respectively (WBS 4.2.2). The PMA modules will require organizing and assembling reports into a standardized format, setting context and drawing overall conclusions. In addition to submission of the PMA modules, Avita will also draft (and get FDA-approval of) a Conditions of Approval study protocol (WBS 3.3.1.1, 4.2.2.4.2), and pass through a panel (of experts) review (WBS 4.2.2.5). Avita will need favorable reviews of the PMA modules, CoA protocol approval, and panel review to get the product approved.

Concurrent with the FDA approval process, there is an Emergency Use pathway, activated in the event of a mass casualty, which would enable FDA to authorize use of an investigational (unapproved) product for life-saving measures. There is “pre-emergency” work that can be done to facilitate a future potential Authorization. (WBS 4.1)

Once there is confidence in EUA status or there is PMA approval, base procurement (WBS 7.1.1) is triggered.

There are several other items that are part of the program in order to ensure success in stockpiling, distributing, and using ReCell during an emergency event:

 

  1.

Training of medics for use of ReCell in mass casualty events (WBS 2.1.1).

 

  2.

Increased shelf-life, with a target of up to 4 years (as supported by stability testing) (WBS 2.3)

 

  3.

VMI planning/implementation (WBS 7.2, 7.3, 7.4)

 

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  4.

Optimize product packaging more for palletized storage and VW, (WBS 5)

 

  5.

Qualifying second sources for key components and for product final assembly (i.e. alternative/supplementary sources for enzyme and a supplement/alternative to [**]) (WBS 6.2.2).

CLIN 0001A Overview

The objectives of CLIN 0001a are to facilitate the overarching objective of preparedness for effective treatment of burn injuries secondary to detonation of a nuclear device. In addition to ensuring FDA approval of the ReCell device, the work put forward in this SOW further bolsters efforts for development of familiarity and acceptance of the autograft-sparing product within U.S. Burn Centers by expanding Compassionate Use (WBS 2.1.5), extending Continued Access (WBS 2.1.6), incorporating Reimbursement training (WBS 2.1.6) and Modeling the Economic Benefits of Medical Countermeasures (WBS 2.1.8).

Additionally, this SOW includes scope to ensure successful navigation of the PMA Pathway by adding a BIMO Mock Audit and adding in-house technical and regulatory expertise for overall support to de-risk the program (4.3.1)

CLIN 0001/0001A- Base Period

 

1.0

Program Management

 

  1.1

Internal Project Management

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
1.1.5 Integrated Master Project Plan    Upon delivery to and acceptance by BARDA    All required elements of this plan as listed in the RFP

 

  1.1.5

Title: Integrated Master Project Plan

Objective/Description of Work: Avita will compile all necessary materials and finalize all aspects of the project related to preparing the Integrated Master Project Plan. This will include finalizing critical path milestones, Work Breakdown Structure (WBS), and Risk Mitigation Plan. The final deliverable of the IMPP will represent the finalization and approval of all project elements between Avita and BARDA.

 

  Milestones:

 

  1.1.5.1

Critical Path Milestones — The critical path milestones are finalized and submitted, reviewed, and approved by BARDA.

 

  1.1.5.2

Work Breakdown Structure—The WBS is finalized and submitted, reviewed, and approved by BARDA for all project activities.

 

  1.1.5.3

Risk Mitigation Plan/Matrix — Any additional elements of risk are identified and all elements of risk are finalized and submitted, reviewed, and approved by BARDA. Risk management plans for each risk are finalized and submitted, reviewed, and approved by BARDA.

 

  Deliverables:

 

  1.1.5

Integrated Master Project Plan Containing all required elements as listed in the RFP and/or requested by BARDA.

 

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  1.1.5.1

Critical Path Milestones—An updated and finalized critical path milestone document.

 

  1.1.5.2

Work Breakdown Schedule —An updated and finalized WBS document.

 

  1.1.5.3

Risk Mitigation Plan/Matrix—An updated and finalized risk mitigation plan/matrix.

 

  1.2

Contract Management

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN001
1.2.2 Reporting    Upon delivery to and acceptance by BARDA    All required reports as listed in the RFP and requested by BARDA
1.2.3 Meetings    BARDA Kick-Off Meeting    Material Presentation Materials

 

  1.2.2

Title: Reporting

Objective/Description of Work: Avita will comply with all reporting requirements as outlined and formatted in the REP and as requested by BARDA. Reporting will include at a minimum monthly progress reports, annual progress reports, annual invention reports, draft final report, and final report. Additional deliverables such as technology packages, experimental protocols, publication, press releases, security reports, or other reports will be provided to BARDA for review prior to initiation of a corresponding work element, deliverable, or FDA submission.

 

  Milestones:

 

  1.2.2.1

Monthly Progress Report — Delivery to and acceptance by BARDA.

 

  1.2.2.2

Annual Progress Report — Delivery to and acceptance by BARDA.

 

  1.2.2.3

Invention Reports — Delivery to and acceptance by BARDA.

 

  1.2.2.4

Draft Final and Final Progress Reports — Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.2.2.1

Monthly Progress Report — A report detailing the prior month’s activities and activities planned for the following month. Report will be delivered prior to the 15th of the month following the reporting period.

 

  1.2.2.2

Annual Progress Report — A report summarizing the activities of the period of performance and the activities planned for the upcoming period. Report will be delivered prior to the 30th of the month following the reporting period.

 

  1.2.2.3

Annual/Final Invention Report — A report detailing any intellectual property developed as a result of the work performed during each period of performance and the entire contract period. Report will be delivered in conjunction with the annual progress report.

 

  1.2.2.4

Draft Final and Final Progress Report—The Final Progress Report will include a complete summary of all work performed during the entire contract period of performance. A Draft Final Progress Report will be delivered 45 days prior to contract expiration for BARDA review and comments. A Final Progress Report will be delivered prior to 30 days following contract expiration.

 

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  1.2.3

Title: Meetings

Objective/Description of Work: Avita and BARDA will engage in regular meetings to coordinate and review project activities. Meetings will be both face-to-face and teleconference/video conference. The first official meeting will be the face-to-face kick-off meeting, followed by status update meetings on a biweekly/monthly basis, ad hoc teleconferences and site visits, and annual meetings to report on the period of performance activities.

 

  Milestones:

 

  1.2.3.1

Kickoff Meeting with BARDA — The contract is awarded and a face-to-face kickoff meeting is conducted within 30 days of award date.

 

  Deliverables:

 

  1.2.3.2

Kickoff Meeting Presentation Materials — Avita will prepare all necessary presentation materials for the kickoff meeting.

 

  1.4

IMS and EVM

 

WBS# and Title

  

Milestone

  

Deliverable

1.4.2 Performance Measurement Baseline    Performance Measurement Baseline Review (PMBR)    All required components for the PMBR
1.4.3 Integrated Master Schedule    PMBR    Integrated Master Schedule
1.4.4 Monthly Earned Value Performance Report    Delivery to and acceptance by BARDA    Monthly Earned Value Performance Report
1.4.5 Supplemental monthly CAP report    Delivery to and acceptance by BARDA    Supplemental monthly CAP report

 

  1.4.2

Title: Performance Measurement Baseline

Objective/Description of Work: The Performance Measurement Baseline will provide a master schedule of deliverables, costs, and milestones in order to completely cover all items in the SOW. All required components will be submitted to BARDA within 90 days of contract award. BARDA and Avita will mutually agree on the budget, schedule and technical plan baselines as a result of the PM BR.

 

  Milestones:

 

  1.4.2

Performance Measurement Baseline Review — The PMBR plan is submitted and reviewed by BARDA.

 

  Deliverables:

 

  1.4.2

Performance Measurement Baseline Review Plan and Required Components — A plan detailing a schedule of deliverables, costs, milestones, and risks that will serve as the basis for measuring project progress.

 

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  1.4.3

Title: Integrated Master Schedule (IMS)

Objective/Description of Work: The IMS will be used to monitor performance of the contract. Avita will develop an IMS in a format approved by BARDA in order to track key milestones, Go/No Go decision gates. The IMS will contain baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. Avita will provide a baseline IMS for the PMBR and monthly updates thereafter.

 

  Milestones:

 

  1.4.2

Integrated Master Schedule is approved by BARDA.

 

  Deliverables:

 

  1.4.3

Integrated Master Schedule — Provided for the PMBR and monthly in order to monitor performance of the contract. The IMS shall be provided at the work package level in MS Project file format.

 

  1.4.4

Title: Monthly Earned Value Performance Report

Objective/Description of Work: The Monthly Earned Value Performance Report will be generated from Avita’s EVMS in order to track any project variances against the baseline. The report will contain technical, schedule, and cost status information in order to identify any issues that may impact project progress and/or cost.

 

  Milestones:

 

  1.4.4

Monthly Earned Value Performance Report — Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.4.4

Monthly Earned Value Performance Report — Provided monthly to track project progress according to WBS and EV variance.

 

  1.4.5

Title: Supplemental Monthly CAP Report

Objective/Description of Work: The Supplemental Monthly CAP Report will be generated from Avita’s EVMS and will contain cost information to report on the time phased budget, earned value, and actual costs of work performed. The report will be submitted monthly to BARDA for review.

 

  Milestones:

 

  1.4.5

Supplemental Monthly CAP Report — Delivery to and acceptance by BARDA.

 

  Deliverables:

 

  1.4.5

Supplemental Monthly CAP Report — Provided monthly to detail time phased budget, earned value, and actual costs of work performed as captured by Avita’s EVM systems.

 

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Non-Clinical Objectives

 

2.1

Efficacy and Safety

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
2.1.1.1 Updated training resources for mass casualty    Effective training for mass casualty event.    Updated user training documentation
2.1.2 Biocompatibility review    Biocompatibility review complete    Biocompatibility Review Report
2.1.3 Human Factors    FDA requests human factors studies    Human factors studies submitted to FDA
2.1.4 FDA-compliant design documentation    Completion of backup documentation for PMA module 1.    QSR-mandated design control documents and supporting lab test results
2.1.5 Compassionate Use IDE    Deliver to BARDA the annual IDE report on Compassionate Use.    Annual IDE report on Compassionate Use.
2.1.6.1 Continued Access IDE 13053    Deliver to BARDA the clinical trial protocol (CTP) on Continued Access.    Clinical trial protocol (CTP) on Continued Access.
2.1.6.2 Annual IDE Report    Deliver to BARDA the Annual IDE reports    Annual IDE reports
2.1.6.3 Final Clinical Study Report    Deliver to BARDA the Final Clinical Study Report    Final Clinical Study Report
2.1.7 Burn Center Reimbursement educational materials    Deliver to BARDA the Guidance materials on reimbursement.    Guidance materials on reimbursement.
2.1.8.1 Kick-off Meeting & Project Management    Complete Kick-off Meeting    MS PowerPoint presentation outlining understanding of goals, objectives, anticipated approach, and project deliverables, milestones, and timeline.
2.1.8.2 Targeted Literature Search    Complete Literature Search    Draft and final literature review search strategy in MS Word
2.1.8.3 Focusing goals    Complete Briefing which defines focus of goals    A brief MS PowerPoint presentation outlining options for the model framework
2.1.8.4 Model Storyboard    Completion of Model Storyboard    Draft and revised model storyboards (MS PowerPoint).

 

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WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
2.1.8.5 KOL Engagement    Complete Recruitment of KOL’s    KOL recruitment and management (for [**] KOLs), draft and final KOL summary feedback (Word) for all KOL meetings, final storyboard (MS PowerPoint). KOL’s to be approved by BARDA.
2.1.8.6 Preliminary Model Programming and Results    Complete Preliminary Model    Preliminary model (MS Excel 2013 file for PC) and a presentation of preliminary findings in a MS PowerPoint slide deck to be shared with BARDA via WebEx or during an in-person meeting.
2.1.8.7 Final Model    Complete Final Model    Final model version (in MS Excel) and final results slides (in MS PowerPoint); quality assurance documentation (MS Word) can be made available upon request.
2.1.8.8 Technical Reporting    Complete Final Technical Report    Two drafts and a final version of a written technical report (MS Word).

 

  2.1.1.1

Title: Updated training resources for mass casualty

Objective/Description of Work: Existing training manuals for use of the ReCell device are designed for a clinical/surgical setting by experienced clinicians. Led by the Director of Education, with support from the Education Specialist, Avita will develop a new training protocol sufficient for a mass casualty event for ReCell to be used by minimally trained personnel that may or may not have burn surgery experience. Target goal will be a one-hour training session to personnel at a trained medic level or higher. New training materials will be submitted to BARDA for review/feedback and then finalized.

 

  Milestones:

 

  2.1.1

Creation of training materials, including video, workshop/online course materials, reference guides, as determined in collaboration with BARDA

 

  Deliverables:

 

  2.1.1.1

Training materials as determined in collaboration with BARDA.

 

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  2.1.2

Title: Biocompatibility review complete

Objective/Description of Work: Full biocompatibility is demonstrated for EU and Australia, to ISO standards. The testing work needs to be done to US FDA standards. Results of biocompatibility review will be submitted to BARDA for review/feedback.

 

  Milestones:

 

  2.1.2

Biocompatibility submitted to FDA

 

  Deliverables:

 

  2.1.2

Biocompatibility Review Report draft and final report submitted to BARDA and final report submitted to FDA

 

  2.1.3

Title: Human Factors

Objective/Description of Work: Avita will conduct an evaluation to ensure that the ReCell devices meet usability guidelines when used by the intended user population. Avita will conduct all required studies and submit the results to BARDA for review and feedback. Upon BARDA approval, Avita will submit report to FDA.

 

  Milestones:

 

  2.1.3

Requested data/report submitted to FDA

 

  Deliverables:

 

  2.1.3

As requested by FDA, human factors draft and final reports submitted to BARDA and final data and report submitted to FDA

 

  2.1.4

Title: FDA-Compliant Design Documentation

Objective/Description of Work: Avita’s recent gap analysis for PMA module 1 readiness indicates that in addition to biocompatibility testing Avita will need to create an FDA QSR-compliant design control document package, including backup lab test data and reports, including packaging testing. Avita will provide the various reports to BARDA, as requested, for review and approval prior to sending to FDA.

 

  Milestones:

 

  2.1.4.1

Functional Testing Complete

 

  2.1.4.2

Packaging/Shipping Testing Complete

 

  2.1.4.3

EMI/EMC Testing Complete

 

  2.2

Non-clinical data sufficient for PMA module 1 of 1

 

  Deliverables:

 

  2.1.4

QSR-mandated design control documents and supporting lab test results — Avita will generate a design control document package that will meet current FDA requirements, in support of PMA module 1 of 1

 

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  2.1.5

Title: Compassionate Use IDE 15945

Objective/Description of Work: Avita’s Compassionate Use IDE provides a mechanism for surgeon access to ReCell as an investigational device, for patients presenting with life-threatening injuries for which there is insufficient donor skin for conventional autograft treatment. Requests, along with a letter of support, are evaluated for suitability and patients are approved by Avita on a case by case basis. Surgeons may request Compassionate Use regardless of their prior experience with ReCell and independent from their site’s participation in IDE 13053 (for the study of burns). The Compassionate Use IDE provides for further experience in the use of ReCell, toward fulfilment of BARDA’s objective of familiarity/acceptance in US burn centers. Avita personnel travel to support these surgeries, and a 3`d-party CRO and an independent consultant are contracted to perform clinical monitoring for compliance with Good Clinical Practice. In-house regulatory personnel will draft associated regulatory submissions.

 

  Milestones:

 

  2.1.5

Deliver to BARDA the annual IDE report on Compassionate Use.

 

  Deliverables:

 

  2.1.5

Annual IDE report on Compassionate Use.

 

  2.1.6

Title: Continued Access IDE 13053

Objective/Description of Work: FDA may allow continued enrollment of subjects after the controlled clinical trial under an IDE has been completed in order to allow access to the investigational medical device while the marketing application is being prepared by the sponsor or reviewed by FDA. Under this policy, a sponsor may propose to conduct an “extended” clinical trial if: 1) there is a public health need for the device and 2) there is preliminary evidence that the device is likely to be effective and no significant safety concerns have been identified for the proposed indication. Avita will submit CTP001-7 to the FDA to allow Continued Access of ReCell at up to 15 clinical sites for treatment of up to an additional 100 patients. As with Compassionate Use, this positions the US burn centers to be more effective in the event of a mass casualty. Onsite training of burn centers will be required, and a 3rd-party CRO will be contracted for clinical project management, clinical data management and clinical monitoring, for compliance with IDE requirements.

 

  Milestones:

 

  2.1.6.1

Continued Access IDE 13053 — Delivered to BARDA

 

  2.1.6.2

Annual IDE Report — Delivered to BARDA

 

  2.1.6.3

Final Clinical Study Report—Delivered to BARDA

 

  Deliverables:

 

  2.1.6.1

Continued Access IDE 13053 Report

 

  2.1.6.2

Annual IDE Report

 

  2.1.6.3

Final Clinical Study Report

 

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  2.1.7

Title: Reimbursement

 

WBS# and Title

  

Deliverable

CLIN0001A
2.1.7 Burn Center Reimbursement educational materials    Guidance materials on reimbursement

Objective/Description of Work: Reimbursement coding is central to establishing familiarity and acceptance of a new product in healthcare. Avita will hire a Reimbursement Manager to establish coding mechanism(s) for ReCell, and this information will be integrated into the educational material provided to burn centers. The support of expert consulting is also anticipated.

 

  Milestones:

 

  2.1.7

Guidance materials on reimbursement—Delivered to BARDA

 

  Deliverables:

 

  2.1.7

Guidance materials on reimbursement

 

  2.1.8

Title: Modeling the Economic Benefits of Medical Countermeasures

Objective/Description of Work: Avita will work with a Subject Matter expert to develop a generic model for cost and economic impact in burn care with introduction of ReCell technology as a candidate for evaluation, both at the single-center level, and a multi-center (commercial) use. The model (aka tool) will allow for evaluation of cost impact on burn care from use of specific products as well as broader economic impact. The tool is expected to be self-standing and include access to other required information such as databases necessary for full functionality and use of the software. Other features of the model will include:

 

  a.

A comprehensive review of parameters which influence the integrated cost impact on burn care (and broader economic impact) both directly or indirectly would be identified and evaluated. Such parameters may include but are not limited to impact of resources (surgical and non-surgical) personnel time, material resources as well tangible changes to the clinical outcomes (example, length of hospital stay or ICU days). Impact of product launch pricing models and potential market share over time may also be included in the tool.

 

  b.

The tool will be designed to predict costs and benefits associated with the care of burn patients based on (i) specifiable characteristics of a hypothetical group of patients (e.g. in terms of burn severity, number of patients, etc) and (ii) modeled changes to fundamental cost drivers associated with particular changes in practice as a result of introduction of the new product and associated downstream impact. As such, the financial and economic impact of introduction of medical countermeasures, alone and in combination, may become predictable.

 

  c.

Avita will test the tool with available data and assumptions and iteratively develop in consultation with the experts to refine the model using ReCell data as well as to ensure the generic nature of the cost and economic Impact tool.

 

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  d.

For this effort it is recognized that definitive burn care is typically provided over time and that care treatments/procedures change as burn etiology evolves. This has allowed for identification of distinct treatment areas within the definitive care continuum. New products (such as Avita’s ReCell) directed at such treatment targets are expected to have an impact on the cost effectiveness of burn care, which represents the over-arching scope of this effort.

 

  e.

For the sake of comprehensive analysis under this effort, an exhaustive list of parameters (preferably ranked) shall be identified and qualified to be measurable within the following treatment targets in the continuum of definitive care: (1) debridement, (2) application of skin substitutes (which eliminate autografting), (3) autograft sparing technology, and (4) adjuncts to enhance/accelerate healing.

 

  f.

The overall capability of the tool is to capture the key parameters across this continuum wherein impact of any new products altering these key parameters within a treatment area, objectively demonstrates a clear, measurable value proposition (or a lack thereof) in the overall cost effectiveness and other attributes. The tool would also feature an ability to be customized either by turning on or off the key parameters or add a user chosen parameter, based on relevance to target area.

 

  g.

Based upon a competitive selection process between three potential SME’s, IMS Health is the primary candidate for this project. A designated panel of experts should be accessible.

 

  2.1.8.1

Title: Kick-off Meeting & Project Management

Objective/Description of Work: A Kick-off meeting will be conducted to:

 

   

Introduce the project team members

 

   

Discuss KOL selection process;

 

   

Review and confirm the goals of the project;

 

   

Finalize the approach to the project phases; and

 

   

Review anticipated project deliverables, milestones and timelines (Gantt chart).

 

  Milestones:

 

  2.1.8.1

Complete Kick-off Meeting

 

  Deliverable:

 

  2.1.8.1

MS PowerPoint presentation outlining understanding of goals, objectives, anticipated approach, and project deliverables, milestones, and timeline.

 

  2.1.8.2

Title: Targeted Literature Search

Objective/Description of Work: Develop literature search strategy and obtain agreement with BARDA. Perform literature search and report on results.

 

  Milestones:

 

  2.1.8.2

Complete Literature Search

 

  Deliverable:

 

  2.1.8.2

Draft and final literature review search strategy in MS Word.

 

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  2.1.8.3

Title: Focusing goals

Objective/Description of Work: Compile a preliminary burn care model structure and identify any key points that may require discussion and agreement between project participants. Develop a discussion deck (in MS PPT) that outlines options for the model framework, including a detailed proposed structure. The deck will be used to facilitate an interactive discussion with BARDA.

Milestones:

 

  2.1.8.3

Complete Briefing which defines focus of goals

Deliverable:

 

  2.1.8.3

A brief MS PowerPoint presentation outlining options for the model framework and structure to facilitate discussion; appended summary of action items.

 

  2.1.8.4

Title: Model Storyboard

Objective/Description of Work: Develop a Model Storyboard, which is a detailed plan for the model, intended to provide an opportunity for discussion and agreement with BARDA, prior to programming. This storyboard will include the model structure to facilitate cost effectiveness and budget impact assessments, detailed parameter types (including all clinical inputs and costs), with referenced default values for all variables, as well as model user-functionality and model outputs.

Although this model will be developed to have a generic structure, the storyboard and model development will be performed to permit evaluation of Avita’s ReCell technology. One primary comparator (e.g. a standard autograft procedure) will serve as the base case for the cost-effectiveness evaluation, and will focus the storyboard accordingly with detailed input values around ReCell and the base case comparator. The model will be developed to include up to three (3) dummy comparators to permit exploration of additional interventions at points along the burn care pathway, but data specific to these hypothetical interventions will not be included in the storyboard or analyses. Because the US model may be used in discussions with different types of stakeholders, it is anticipated that the storyboard will include information to inform different perspectives, including hospital perspective, payer perspective, and at BARDA’s option, societal perspective. Differences between these may include time horizon (shorter term for hospital perspective) and cost inputs. It is assumed that budget impact calculations will rely on the same underlying structure and inputs as are used for the cost- effectiveness model, and thus gain efficiencies between the two analysis types. However, pricing predictions, market uptake assumptions and market share distribution will be required from marketing research. Any additional detailed clinical and cost input values not available from other sources may be solicited from KOLs (e.g. likely resource use assumptions); based on discussion with KOLs, however, a survey or database analysis Optional Task may be desired to obtain the best possible data.

After presentation of the storyboard to BARDA, comments received during this meeting and any additional consolidated comments received in the following week will be incorporated into a storyboard revision. Input from all internal stakeholders at this phase will ensure the model contains the appropriate elements and addresses key considerations. This revision will serve as the platform for the first KOL engagement.

 

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Milestones:

 

  2.1.8.4

Completion of Model Storyboard

Deliverable:

 

  2.1.8.4

Draft and revised model storyboards (MS PowerPoint).

 

  2.1.8.5

Title: KOL Engagement

Objective/Description of Work: Engage three KOLs for the following:

 

   

One hour each for a meeting to collect feedback on the proposed model storyboard;

 

   

One additional hour each to help fill any key model data gaps (e.g. providing resource use assumptions);

   

A two-hour advisory panel (joint meeting) for a discussion of the preliminary model and results. (At Avita’s option, this may be redefined as a half-day advisory board with KOLs and all project participants. Please see Optional Tasks.)

Engage with the KOLs via teleconference, utilizing presentation materials generated during other project tasks, including the storyboard and preliminary model results presentation. Provide a short written summary of meeting minutes and implications for analysis following ach discussion. Following one round of review, the summary of feedback (meeting minutes) document will be considered final, and details will be incorporated into a final version of the storyboard.

The budget assumes [**] US-based KOLs. Payment of honoraria will be contracted in accordance with Avita governance procedures. Any fees paid by will be considered as pass-through costs to BARDA and will be clearly reported and documented.

Milestones:

 

  2.1.8.5

Complete Recruitment of KOL’s

Deliverable:

 

  2.1.8.5

KOL recruitment and management (for [**] KOLs), draft and final KOL summary feedback (Word) for all KOL meetings, final storyboard (MS PowerPoint). KOL’s to be approved by BARDA

 

  2.1.8.6

Title: Preliminary Model Programming and Results

Objective/Description of Work: Initiate programming the model for use on a PC platform with MS Excel 2013. Populate the model with parameter estimates, and use the model to generate preliminary estimates of the cost- effectiveness of using ReCell technology vs a chosen appropriate comparator available perspectives (e.g. hospital, payer, and (optional) US society), and of the budget impact of adding ReCell to the available burn care therapies. Include up to three (3) dummy comparators into the model (one for each phase of the burn care pathway) to permit evaluation of the impact of other therapeutic options. Model programming will also include a univariate sensitivity analysis function to identify the most sensitive parameters in the model, displayed as a tornado diagram for convenient interpretation and reporting.

 

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At this stage, Avita will outline preliminary model results, and will present the draft results to BARDA to obtain internal feedback, and also deliver the preliminary model to ensure transparency.

After collecting initial feedback from BARDA, engage the [**] KOLs in a single 2-hour meeting for collective review and validation.

Milestones:

 

  2.1.8.6

Complete Preliminary Model

Deliverable:

 

  2.1.8.6

Preliminary model (MS Excel 2013 file for PC) and a presentation of preliminary findings in a MS PowerPoint slide deck to be shared with Avita via WebEx or during an in-person meeting.

 

  2.1.8.7

Title: Final Model

Objective/Description of Work: Develop the final version of the model and update the preliminary results slides with final results to be shared with BARDA via WebEx or during an in-person meeting. The model will be developed for two US perspectives, and at BARDA’s option, may include a third. The scope of work assumes that the costing model will contain two perspectives (hospital, payer), and one primary comparator to ReCell (e.g. standard of care autografting), with dummy structure for three (3) additional comparators (i.e. intervention-specific data will not be prepopulated for these dummies).

Milestones:

 

  2.1.8.7

Complete Final Model

Deliverable:

 

  2.1.8.7

Final model version (in MS Excel) and final results slides (in MS PowerPoint); quality assurance documentation (MS Word) can be made available upon request.

 

  2.1.8.8

Title: Technical Reporting

Objective/Description of Work: Prepare a written report which includes a description of the project objectives, methods (including structure, referenced parameter values, and analytic outcomes), results, and concluding summary of the results ( 520 pages).

Milestones:

 

  2.1.8.8

Complete Final Technical Report

Deliverable:

 

  2.1.8.8

Two drafts and a final version of a written technical report (MS Word).

 

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  2.1.8.9

Title: Optional Supplemental Project Tasks

Objective/Description of Work: The following is a list of representative tasks that may be required. This task list may be modified and/or supplemented in accordance with written direction and approval from BARDA.

 

   

Option 1: Abstract and poster

 

   

Option 2: Scientific manuscript

 

   

Option 3: Adding societal perspective to the model

 

   

Option 4: Expert survey to obtain missing data

 

   

Option 5: Database analysis to obtain missing data

 

   

Option 6: Half-Day advisory board to review and discuss preliminary model

 

   

Option 7: Dynamic summary report

 

   

Option 8: iPad tool adaptation

 

   

Option 9: Bank of Hours to Support Scope Amendments

 

   

Option 10: Detailed Analysis of Patient Level Data:

 

   

Analysis will include ICD codes (such as under ICD9, 10 ),HCPCS code-Level data, CPT code-Level data, Revenue code-Level data and other data sources such as the Healthcare Blue Book. These data can be used to assess data provided by providers on resource use (hospital LOS, frequency of dressing changes, use of diagnostics and disposables, blood transfusions, escharotomies, autografting, etc.) at each stage in the treatment timeline (debridement, autografting, etc.)

 

  2.3

Stability and Review of Extended Shelf Life

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
2.3.1 Stability Plan    Expiration limiting components identified and plan developed to extend to [**] year target    Stability Plan
2.3.6 Stability Report (accelerated aging)    Accelerated aging testing results complete    Stability report
2.3.7 Stability report (real- time aging)    Real-time aging testing results complete    Stability report
2.3.8 Review of extended shelf life    New expiry limits determined    Results report submitted to BARDA
2.3.9 Revisions to labeling    Stability extension submission    Shelf life report and revised labeling submitted to FDA

 

  2.3.1

Title: Stability Plan

Objective/Description of Work: Avita will develop a stability plan that will outline the testing necessary to extend the shelf life of the ReCell unit to [**] years in order to minimize product losses due to expiry. Avita will focus on specific expiration-limiting components (enzyme and buffer, RPU, and nozzle). Avita will design and execute on a stability testing plan to verify stability for extension of shelf life. Reports will be submitted to BARDA detailing the shelf life of ReCell units. Labeling will be modified based on new expiries and submitted to FDA to approval.

 

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Milestones:

 

  2.3.1

Expiration limiting components are identified and a plan is developed to extend ReCell unit to a target of [**]-year expiry.

Deliverables:

 

  2.3.1

Stability plan outlining all necessary real-time and accelerated aging testing required to justify expiry.

 

  2.3.6

Title: Stability Report (accelerated aging)

Objective/Description of Work: Following accelerated aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.6

Stability testing results complete.

Deliverables:

 

  2.3.6

Stability report detailing product performance for ReCell components after aging

 

  2.3.7

Title: Stability Report (real-time aging)

Objective/Description of Work: Following real-time aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.7

Stability testing results complete.

Deliverables:

 

  2.3.7

Stability report detailing aged performance for ReCell components

 

  2.3.8

Title: Review of extended shelf life

Objective/Description of Work: Avita will prepare a report for BARDA detailing the changes product shelf life. Avita will report on the plan for accordingly revised product labeling to be submitted to FDA.

Milestones:

 

  2.3.8

Delivery of report of extended shelf life

Deliverables:

 

  2.3.8

Shelf life report delivered to BARDA for review, followed by a report detailing plans for FDA submission, and implications for the VMI.

 

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  2.3.9

Title: Revisions to labeling

Objective/Description of Work: Avita will revised the product labeling to reflect new shelf life parameters, and will submit to FDA.

Milestones:

 

  2.3.9

FDA approval of revised product labeling

Deliverables:

 

  2.3.9

New product labeling and FDA submission for review/approval of new product labeling.

 

2

Clinical

 

  3.1

Pivotal Clinical Trials

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
3.1.1.4 Clinical Study Report    CTP001-5 Clinical Study Report (CSR) complete, review    CTP001-5 Clinical Study Report (CSR), review/submit to FDA
3.1.2.6.1 Statistical Analysis (9mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.2 Clinical Study Report (9mo)    CTP001-6 Initial (9- months) CSR complete    CTP001-6 Initial (9 months) CSR, review (PMA module 3 of 3)
3.1.2.6.4 Statistical Analysis (12mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.5 Clinical Study Report (12mo)    CTP001-6 Final (12- months) CSR complete    CTP001-6 Final (12 months) CSR, review

 

  3.1.2.8

Title: Final CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pivotal Clinical Trials encompass two ongoing clinical protocols: CTP001-5 (deep partial-thickness) and CTP001-6 (mixed depth including full-thickness). Both studies show definitive closure using less donor skin with ReCell as compared to standard care, and are also looking at long-term scar outcomes. The clinical study report (CSR) from CTP001-6 is the primary component of PMA module 3 of 3. All CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.1.1.1

Last subject last visit for CTP001-5 (complete)

 

  3.1.1.4

Clinical Study Report complete for CTP001-5

 

  3.1.2.1.1

FDA Statistical Analysis Plan submitted and approved by FDA for CTP001-6 (complete)

 

  3.1.2.3.2

Last subject last visit for CTP001-6

 

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  3.1.2.6.4

CRO completes 9-month statistical analysis for PMA module 3 of 3. 3.1.2.8 Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.1.1.4

CTP001-5 Clinical Study Report (CSR)

 

  3.1.2.6.1

CTP001-6 9-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.2

CTP001-6 Initial (9-months) CSR (for PMA module 3 of 3)

 

  3.1.2.6.4

CTP001-6 12-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.5

CTP001-6 Final (12-months) CSR

 

3

Regulatory

 

  4.1

Pre-Emergency Use Authorization

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
4.1 Pre-Emergency Use Authorization    Avita completes all submissions needed for EUA    All data requested by BARDA to obtain pre-EUA

 

  4.1

Title: Pre-Emergency Use Authorization

Objective/Description of Work: Avita will support BARDA/HHS in obtaining a Pre-Emergency Use Authorization for the ReCell device. All required studies, reviews, reports, and analyses will be provided as requested.

Milestones:

4.1 Avita completes all submissions needed for EUA

Deliverables:

4.1 Submission to BARDA/HHS of all required materials needed for Pre-EUA.

 

  4.2

Premarket Approval (PMA)

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
4.2.2.1.4 Module 1 Submission    Module 1 package assembled    Module 1 package to FDA
4.2.2.2.4 Module 2 Submission    Module 2 package assembled    Module 2 package to FDA
4.2.2.3.4 Module 3 Submission    Module 3 package assembled    Module 3 package to FDA
4.2.2.5.3 Create action plan to address panel recommendations    FDA Panel Meeting    Action Plan

 

  4.2.2.1.4

Title: Module 1 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package with modular submissions for FDA review and approval. The PMA package will consist of three PMA modules. Module 1 will focus on non-clinical data.

 

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Milestones:

 

  4.2.2.1.4

Module I package assembled

Deliverables:

 

  4.2.2.1.4

Module 1 submission to FDA — Module 1 includes biocompatibility, human factors, shipping/packaging validation, EMI/EMC, and all other required non-clinical data.

 

  4.2.2.2.4

Title: Module 2 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 2 will focus on manufacturing data.

Milestones:

 

  4.2.2.2.4

Module 2 package assembled

Deliverables:

 

  4.2.2.2.4

Module 2 submission to FDA — Submission will include the principles of operation, quality system and manufacturing documentation, sterilization, shelf-life information, and packaging information.

 

  4.2.2.3.4

Title: Module 3 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 3 will focus on clinical data. Module 3 will be submitted to BARDA for review and approval, followed by submission to FDA.

Milestone:

 

  4.2.2.3.4

Module 3 package assembled and approved by BARDA

Deliverables:

 

  4.2.2.3.4

Module 3 submission to FDA — Submission will include the CTP001-6 clinical data labels and manuals, draft post-marketing plan (CoA study protocol) and bibliography.

4.3 Title: BIMO Mock Audit and Enhanced in-house support of the PMA Pathway

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001A
4.3.1    Complete Remediation of Trial Master Files    Submit BIMO Mock Audit Report and remedial action plan.

Objective/Description of Work: Prepare for and execute a BIMO Mock Audit to review the Trial Master Files (TMF) at Avita and to audit the site files of [**] selected burn centers participating in IDE 13053. Avita will subsequently prepare a remedial action plan, and then correct deficiencies as identified by the mock auditing. The status of the remediation activity will be reported in Avita’s monthly progress report to BARDA. Ensure availability of in-house regulatory, quality, engineering and manufacturing subject matter experts to respond to the following:

 

   

Clinical and non-clinical data questions, findings, deficiencies & remediation.

 

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Technical and regulatory questions from BARDA and FDA in response to Avita’s submission of documents and reports.

 

   

Implementation of design and manufacturing change requests and process improvements as a result of review and feedback.

Milestone:

 

  4.3.1

Complete Remediation of Trial Master Files

Deliverables:

 

  4.3.1

Submit BIMO Mock Audit Report and remedial action plan.

 

4

Product Development for mass casualty/VMI

 

  5.1

Requirement Gathering, 5.2 Product Design, 5.3 Systems Requirements and Design Review, and 5.4 CDC Quality Agreement

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
5.3 Systems Requirements (VMI optimization) and Design Review    Review of VMI optimized product design package complete    Product optimized for VMI Design Package
5.4 CDC Quality Agreement    Executed CDC Quality Agreement    CDC Quality Agreement

5.3 5.4 Title: Systems Requirements (VMI optimization) and Design Review

Objective/Description of Work: In order to develop a product ready for manufacturing and stockpiling, Avita will work with BARDA to first gather the requirements for DFM/DFA, inventory management and any other requirements. Based on the requirements, Avita will initiate Product Design to all ensure the product will meet specifications. This includes design and review for any changed or affected part: Components, Subassembly, Product System, and Packaging Design. Document package will be sent to BARDA for review. Avita will work with CDC to establish a quality agreement, if required.

Milestones:

 

  5.1

Requirements document compiled from BARDA

 

  5.2.1.2

Component Design Review complete

 

  5.2.2.2

Subassembly Design Review complete

 

  5.2.3.2

Product System Design Review complete

 

  5.2.4.2

Packaging Design Review complete

 

  5.3

Full systems requirements and design review complete and approved by BARDA

 

  5.4

If required, establish quality agreement with CDC for supporting VMI

 

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Deliverables:

 

  5.3

System Requirements and Design Review — A system requirements and design review report will be submitted to BARDA containing the requirements and the design changes made to meet those requirements.

 

  5.4

Agreed upon CDC quality agreement for supporting VMI (if required)

 

  5.5

Verification and Validation

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
5.5 Verification and Validation Report    V&V verifies product meets specifications and requirements    V&V Report

 

  5.5

Title: Verification and Validation Report

Objective/Description of Work: Verification & Validation are used to verify that the product meets the specifications and requirements and address the intended purpose. Verification demonstrates that the product meets specification and Validation demonstrates fitness of use for the intended purpose. Once V&V results are positive, the product is ready to release to manufacturing. Avita will submit a report to BARDA detailing the results of the V&V analysis.

Milestones:

 

  5.5

Testing and analysis indicate that the product meets specification and intended purpose.

Deliverables:

 

  5.5

V&V Report — Avita will submit a report to BARDA detailing the results of the V&V analysis.

 

5

QSR

 

  6.1

Quality System Preparedness

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
6.1.3 3rd Party Audit    Audit completed    QSR Audit Report

 

  6.1.3

Title: 3rd Party Audit

Objective/Description of Work: The US FDA Quality System Regulation (QSR) describes the environment under which medical device firms must operate. This task involves preparing the Avita quality systems for FDA review and inspection, and verifying compliance with FDA requirements. Avita hired an external 3rd party auditor to complete a QSR gap analysis. Following the audit a gap assessment was prepared and presented to Avita from the 3rd party auditor. Avita will develop a Gap Corrective Action plan to address any gaps identified. This will support PMA submission. Once the corrective action plan has been implemented and changes are in place a mock audit will be performed by a 3rd party auditor in preparation for an expected FDA inspection during PMA review.

 

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Milestones:

 

  6.1.1

Gap Assessment

 

  6.1.2

Gap corrective action performed and all systems brought into compliance

 

  6.1.3

Mock QSR audit

Deliverables:

 

  6.1.3

QSR 3rd Party Audit Report - Avita will submit a report to BARDA detailing the results of the final QSR audit.

 

  6.2

Commercial Manufacturing

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
6.2.1 Commercialization Plan and Gap Analysis    Completion of commercialization plans    Final Commercialization Plan
6.2.2.4 Validation Report    10/0Q/PQ process validations complete    Validation Report

 

  6.2.1

Title: Commercialization Plan and Gap Analysis

Objective/Description of Work: Perform a gap analysis to assess commercialization readiness and draft a commercialization plan in support of market entry. Tasks include, as necessary, establishing SKU#, Supply chain and vendor qualifications, raw material inventory, sterilization, packaging, and labeling, and lot release.

Milestones:

 

  6.2.1.1

Commercialization Gap Assessment completed

 

  6.2.1.2

Commercialization Plan Draft created, reviewed with BARDA

 

  6.2.1.3

Commercialization Plan finalized.

Deliverables:

 

  6.2.1.1

Commercialization Gap Assessment Report

 

  6.2.1.2

Commercialization Plan draft and final versions reviewed and submitted to BARDA.

 

  6.2.2.4

Title: Validation Report

Objective/Description of Work: Process validation involves the collection and evaluation of data from the processes used to produce the product. Avita’s commercial manufacturer will lead the effort in manufacturing, under close supervision and collaboration with Avita. Sterile packaging will be a primary focus of the validation effort to ensure repeatable package integrity and valid sterilization processes. Process validations will include 1Q/0Q/PQ and final validation. Avita will present a final report detailing the results of the validation analysis.

Milestones:

 

  6.2.2.1

IQ, Installation Qualification complete

 

  6.2.2.2

00, Operation Qualification complete

 

  6.2.2.3

PO, Process Qualification complete

 

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Deliverables:

 

  6.2.2.4

Validation Report - Avita will submit a report to BARDA detailing the results of the process validation analysis.

CLIN 0002 — Base Period

 

6

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
7.1.1.2 Product Manufacturing    Order Received    Initial Product
7.1.1.3 Deploy product to VMI sites    Product shipped to sites    Product deployed

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: Upon authorization from BARDA, Avita will cause the production and delivery of ReCell devices. Upon receiving the order Avita will authorize the manufacturer to procure supplies for the manufacture of the devices and preparing designated inventory locations.

Milestones:

 

  7.1.1.1

Order Received

 

  7.1.1.2

Delivery of specified quantity of units to VMI.

Deliverables:

 

  7.1.1.2

Initial Product — Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices.

 

  7.1.1.3

Product integrated into VMI and available for deployment

 

  7.2

VMI Remote inventory management system

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN001
7.2.1 - Gather VMI Requirements    All VMI requirements agreed upon with BARDA    VMI Requirements Document

 

  7.2.1

Title: Gather VMI Requirements

Objective/Description of Work: Avita will work with USG to identify all VMI requirements, and prepare a document detailing the requirements.

Milestones:

 

  7.2.1

All VMI requirements agreed upon with BARDA

Deliverables:

 

  7.2.1

VMI Requirements Document—Report detailing the agreed upon requirements for VMI.

 

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  7.4

Sustainment/Stockpile Management

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
7.4.1 Inventory Management    Quarterly inventory reports    Inventory Management Report

Avita Medical OPTION SOW

 

Summary Table

 

CLIN

  

WBS 1st

Level

Element

  

Title

  

Objectives

0003    3    CoA Study   

•  Complete Post-Approval (conditions of approval) study, as required by FDA

0004    3, 4    Pediatric Studies   

•  Complete pediatric clinical trials per FDA requirements and BARDA guidance

0005    7    Procurement (Surge)   

•  Execute acquisition contract

 

•  Expand VMI as necessary

 

•  Manage inventory

Overview

Avita has defined three option periods covering the Conditions of Approval (CoA) study after FDA approval of the ReCell Device (CLIN 0003), a Pediatric study to expand the indications for ReCell for a broader pediatric demographic, if necessary, for ReCell (CLIN 0004), and for the procurement of additional ReCell devices beyond the initial acquisition (CLIN0005). Note: Updated SOW(s) will be provided to BARDA based on FDA feedback to support the execution of each CLIN. The accompanying budget(s) will also be updated to align with the revised SOW(s).

The purpose of the CoA, CLIN 0003, is to provide longer-term evaluation of the ReCell device after FDA approval, in order to track and confirm that any post-market commitments are addressed by Avita.

The purpose of the Pediatric Study, CLIN 0004, is to expand the approved range of patients for ReCell, specifically for pediatric patients, beyond those originally approved during the PMA process. The specific study design and objectives will be based on the PMA approval outcomes as well as consultation with BARDA, and will be intended to expand the range of patients able to be treated by ReCell.

Surge acquisition, CLIN 0005, will support additional acquisition of ReCell devices by BARDA, CDC, or other stakeholders.

 

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CLIN 0003 — Option — CoA Study

 

3

Clinical

 

  3.3

Post approval (Condition of Approval Study)

 

WBS# and Title

  

Milestone

  

Deliverable

3.3.1.2 Submit protocol to BARDA for review    Protocol developed    Study Protocol
3.3.6.1 Statistical analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.3.6.2 Clinical study report    CSR complete    CSR, review/submit to FDA

 

  3.3.6.4

Title: Final CoA CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Post approval (COA study) will be carried out if an additional study is required by FDA as a condition of PMA approval. If a COA study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.3.1.1

Protocol developed

 

  3.3.2.2

Last subject last visit

 

  3.3.6.1

CRO completes statistical analysis

 

  3.3.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.3.1.2

Study Protocol submitted to BARDA

 

  3.3.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.3.6.2

CSR, review/submit to FDA

CLIN 0004 — Option — Pediatric Study

 

3

Clinical

 

  3.2

Pediatric Study for Expanded Labeling

 

WBS# and Title

  

Milestone

  

Deliverable

3.2.1.2 Submit protocol to BARDA for review    Protocol developed    Study protocol
3.2.6.1 Statistical Analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.2.6.2 Clinical Study Report    CSR complete    CSR, review/submit to FDA

 

  3.2.8

Title: Final Pediatric CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pediatric study for expanded labeling will be carried out if requested by the BARDA to study younger children. If a pediatric study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

 

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Milestones:

 

  3.2.1.1

Protocol developed

 

  3.2.3.1

Last subject last visit

 

  3.2.6.1

CRO completes statistical analysis

 

  3.2.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.2.1.2

Clinical Study Protocol

 

  3.2.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.2.6.2

Clinical Study Report (CSR)

 

4

Regulatory

 

4.2.5

Pediatric Indication

 

WBS# and Title

  

Milestone

  

Deliverable

4.2.5.1 Pediatric IDE    FDA approval of pediatric IDE    Pediatric IDE application
4.2.5.3 Pediatric PMA supplement    FDA approval of expanded indication for pediatrics    Submission for Pediatric label expansion

 

4.2.5

Title: Pediatric Indication

Objective/Description of Work: Avita will make the regulatory filings with FDA for both a pediatric IDE clinical trial and a PMA supplement for expansion of labeling for pediatric indication.

Milestones:

 

  4.2.5.2

FDA approval of pediatric IDE study

 

  4.2.5.4

FDA approval of pediatric indication

Deliverables:

 

  4.1.5.1

Pediatric IDE application.

 

  4.2.5.3

PMA supplement for pediatric indication

CLIN 0005 — Procurement (Surge)

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received    Additional product to meet surge capacity

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

 

Avita Medical Statement of Work, 06/24/2016

HHSO100201500028C

   Page 27

 

 


Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product — Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

 

Avita Medical Statement of Work, 06/24/2016

HHSO100201500028C

   Page 28

 

 

EX-4.6

Exhibit 4.6

 

LOGO

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. Double asterisks denote omissions. AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 4 2. AMENDMENT/MODIFICATION NO. 0003 3. EFFECTIVE DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. OS206970 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE ASPR–BARDA 7. ADMINISTERED BY (If other than item 6) CODE ASPR–BARDA ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) AVITA MEDICAL AMERICAS, LLC 1476585 AVITA MEDICAL AMERICAS, LLC 92 28159 Avenue Stanford Suite 220 Valencia CA 91355 (x) 9A. AMENDMENT OF SOLICITATION NO.    9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. HHS0100201500028C    10B. DATED (SEE ITEM 13) 09/29/2015 CODE 1476585 FACILITY CODE    11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS â–¡ The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers â–¡ is extended.    â–¡ is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing Items 8 and 15, and returning _______________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) 2017.1990008.26402 Net Increase: [**] 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: X D. OTHER (Specify type of modification and authority) 52.217-9 Option To Extend the Term of the Contract E. IMPORTANT: Contractor ☐ is not. ☒ is required to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Tax ID Number: 20-2578762 DUNS Number: 026723570 To modify ARTICLES B.3 OPTION PRICES, C.1. STATEMENT OF WORK, F.1. PERIOD of PERFORMANCE, and SECTION J List of Attachments. Funds Obligated Prior to this Modification: [**] Funds Obligated with mod #03: [**] Total Funds Obligated to Date: [**] PSC Code: 6505 Continued . . . Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) Timothy J. Rooney CFO 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Christopher Scott 15B. CONTRACTOR/OFFEROR                /s/ Timothy J. Rooney (Signature of person authorized to sign) 15C. DATE SIGNED    9/18/17 16B. UNITED STATES OF AMERICA     /s/ Christopher Scott (Signature of Contracting Officer) 16C. DATE SIGNED    9/18/17 NSN 7540-01-152-8070 Previous Edition Unusable STANDARD FORM 30 (REV. 10-83) Prescribed by GSA FAR (48 CFR) 53.243

 

1


CONTINUATION SHEET   

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHS0100201500028C/0003

   PAGE OF
   2    4

 

NAME OF OFFEROR OR CONTRACTOR

AVITA MEDICAL AMERICAS, LLC 1476585

 

ITEM NO.

(A)

  

SUPPLIES/SERVICES

(B)

   QUANTITY
(C)
     UNIT
(D)
     UNIT PRICE
(E)
     AMOUNT
(F)
 
  

Expiration date: [**], 2022 (Changed)

 

Delivery Location Code: HHS

HHS

200 Independence Avenue, SW

WASHINGTON DC 20201 US

 

Appr. Yr.: 2017 CAN: 1990008 Object Class: 26402

FOB: Destination

Period of Performance: [**]/2015 to [**]/2022

 

Change Item 4 to read as follows (Amount Shown is the obligated amount):

           

4

  

CLIN 0004 Pediatric Study

Obligated Amount: [**]

              [**]  

NSN 7540-01-152-8070

             

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

 

 

 

 

2


ARTICLE B.3. OPTION PRICES is hereby modified as follows:

 

CLIN

  

Period of

Performance

  

Supplies/ Services

  

Units (# of
Product)

  

Unit Price

($)

  

Total ($)

FIRM FIXED PRICE

0003

(Option)

   [**] Months    Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)    N/A    N/A    [**]
COST REIMBURSEMENT

0004

(Option)

   [**]/17 – [**]/22    Pediatric Study (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)    [**]    [**]    [**]
FIRM FIXED PRICE

0005

(Option)

   36 Months    Additional Surge Capacity   

Less than

2,000

   [**]    [**]

0006

(Option)

   36 Months    Additional Surge Capacity    [**]    [**]    [**]

0007

(Option)

   36 Months    Additional Surge Capacity    [**]    [**]    [**]

0008

(Option)

   36 Months    Additional Surge Capacity    [**]    [**]    [**]
Total Unfunded Option CLINs 3, 5-8    60 Months    See Above Descriptions          [**]

 

*

Option CLIN 0004 is exercised with this modification

ARTICLE C.1. STATEMENT OF WORK is hereby modified as follows:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated [**], 2017 set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.

 

3


ARTICLE F.1. PERIOD OF PERFORMANCE is hereby modified as follows:

The period of performance for this contract shall be from [**], 2015 through [**], 2022. The period of performance for the base period of this contract shall be consistent with the dates set forth in SECTION B. If the Government exercises option(s), the period of performance will be extended as described under in SECTION B of this contract.

SECTION J – LIST OF ATTACHMENTS: Attachment 1 is hereby modified as follows:

 

  1.

Statement of Work, dated September 18, 2017, 44 pages

All other terms and conditions of this contract remain unchanged.

End of Modification #3

 

4


Avita Medical SOW

Advance Understandings

 

The following scope of work is submitted by Avita Medical Americas LLC in compliance with the advanced understandings listed in ARTICLE B of this contract, including invoicing, publications and press releases, protection of human subjects, communication with BARDA, export control, manufacturing standards, contact prohibitions, subcontracting, data handling, confidentiality, compensation, and security reporting.

Avita Medical BASE SOW

 

Summary Table

 

CLIN

  

WBS 1st
Level
Element

  

Title

  

Objectives

0001/0001A    1    Project Management   

•  Establish project management infrastructure

 

•  Establish EVM systems

 

•  Finalize IMPP

 

•  Technical and financial reporting

   2    Non-Clinical Objectives   

•  Close gaps in non-clinical data required for PMA module 1 of 3, including biocompatibility, human factors, packaging testing to generate ISO design dossier as an FDA-compliant design history file.

 

•  Establish appropriate training for use of ReCell in mass casualty setting.

 

•  Achieve 4-year stability

 

•  Expand Compassionate Use IDE 15945 (0001A)

 

•  Extend Continued Access IDE 13053 (0001A)

 

•  Incorporate Reimbursement Methods (0001A)

 

•  Model the Economic Benefits of Medical Countermeasures (0001A)

   3    Clinical Objectives   

•  Complete pivotal trials (-5 and -6 protocols) and clinical study reports for PMA module 3 of 3.

   4    Regulatory Objectives   

•  Fulfill Pre-EUA requirements

 

•  Modular PMA Submission

 

•  Secure Pre-Market Approval (PMA)

 

•  BIMO Mock Audit (0001A)

 

•  Enhanced in-house support of the PMA Pathway (0001A)

   5    Product Development for Mass Casualty/VMI   

•  Gather requirements for Mass Casualty and VMI

 

•  Redesign ReCell packaging and any other subcomponents in order to meet requirements for more efficient VMI and deployment

 

•  Complete V&V

 

 

 

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CLIN

  

WBS 1st
Level
Element

  

Title

  

Objectives

   6    QSR Objectives   

•  Perform QSR Gap remediation (address all gaps identified) for PMA module 2 of 3.

 

•  Scale up manufacturing process for ReCell to support USG acquisition and US Market introduction

 

•  Qualify alternate suppliers, for sustainability

0002    7    Procurement (Initial)   

•  Execute acquisition contract

 

•  Establish VMI

 

•  Manage inventory

CLIN 0001 Overview

Avita’s initial primary objective with the proposed effort is to secure FDA approval for the ReCell device. In order to accomplish this we need (1) a documented design (with documentation and supporting testing ¬e.g. biocompatibility- done to FDA standards rather than ISO standards), for which the work is done in WBS 2.1.2, 2,1.3, and 2.1.4; (2) an FDA-compliant quality system and documentation of GMP manufacturing: WBS 6.1; and (3) Pivotal Clinical Data: WBS 3.1.

The above-mentioned work is delivered to FDA via PMA modules 1, 2 and 3, respectively (WBS 4.2.2). The PMA modules will require organizing and assembling reports into a standardized format, setting context and drawing overall conclusions. In addition to submission of the PMA modules, Avita will also draft (and get FDA-approval of) a Conditions of Approval study protocol (WBS 3.3.1.1, 4.2.2.4.2), and pass through a panel (of experts) review (WBS 4.2.2.5). Avita will need favorable reviews of the PMA modules, CoA protocol approval, and panel review to get the product approved.

Concurrent with the FDA approval process, there is an Emergency Use pathway, activated in the event of a mass casualty, which would enable FDA to authorize use of an investigational (unapproved) product for life-saving measures. There is “pre-emergency” work that can be done to facilitate a future potential Authorization. (WBS 4.1)

Once there is confidence in EUA status or there is PMA approval, base procurement (WBS 7.1.1) is triggered.

There are several other items that are part of the program in order to ensure success in stockpiling, distributing, and using ReCell during an emergency event:

 

  1.

Training of medics for use of ReCell in mass casualty events (WBS 2.1.1).

 

  2.

Increased shelf-life, with a target of up to 4 years (as supported by stability testing) (WBS 2.3)

 

  3.

VMI planning/implementation (WBS 7.2, 7.3, 7.4)

 

  4.

Optimize product packaging more for palletized storage and VMI, (WBS 5)

 

  5.

Qualifying second sources for key components and for product final assembly (i.e. alternative/supplementary sources for enzyme and a supplement/alternative to Parker) (WBS 6.2.2).

 

 

 

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CLIN 0001A Overview

The objectives of CLIN 0001a are to facilitate the overarching objective of preparedness for effective treatment of burn injuries secondary to detonation of a nuclear device. In addition to ensuring FDA approval of the ReCell device, the work put forward in this SOW further bolsters efforts for development of familiarity and acceptance of the autograft-sparing product within U.S. Burn Centers by expanding Compassionate Use (WBS 2.1.5), extending Continued Access (WBS 2.1.6), incorporating Reimbursement training (WBS 2.1.6) and Modeling the Economic Benefits of Medical Countermeasures (WBS 2.1.8).

Additionally, this SOW includes scope to ensure successful navigation of the PMA Pathway by adding a BIMO Mock Audit and adding in-house technical and regulatory expertise for overall support to de-risk the program (4.3.1)

CLIN 0001/0001A- Base Period

 

1.0

Program Management

 

  1.1

Internal Project Management

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
1.1.5 Integrated Master Project Plan    Upon delivery to and acceptance by BARDA    All required elements of this plan as listed in the RFP

 

  1.1.5

Title: Integrated Master Project Plan

Objective/Description of Work: Avita will compile all necessary materials and finalize all aspects of the project related to preparing the Integrated Master Project Plan. This will include finalizing critical path milestones, Work Breakdown Structure (WBS), and Risk Mitigation Plan. The final deliverable of the IMPP will represent the finalization and approval of all project elements between Avita and BARDA.

Milestones:

 

  1.1.5.1

Critical Path Milestones The critical path milestones are finalized and submitted, reviewed, and approved by BARDA.

 

  1.1.5.2

Work Breakdown Structure –The WBS is finalized and submitted, reviewed, and approved by BARDA for all project activities.

 

  1.1.5.3

Risk Mitigation Plan/Matrix – Any additional elements of risk are identified and all elements of risk are finalized and submitted, reviewed, and approved by BARDA. Risk management plans for each risk are finalized and submitted, reviewed, and approved by BARDA.

Deliverables:

 

  1.1.5

Integrated Master Project Plan – Containing all required elements as listed in the RFP and/or requested by BARDA.

 

  1.1.5.1

Critical Path Milestones – An updated and finalized critical path milestone document.

 

  1.1.5.2

Work Breakdown Schedule – An updated and finalized WBS document.

 

  1.1.5.3

Risk Mitigation Plan/Matrix – An updated and finalized risk mitigation plan/matrix.

 

 

 

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  1.2

Contract Management

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
1.2.2 Reporting    Upon delivery to and acceptance by BARDA    All required reports as listed in the RFP and requested by BARDA
1.2.3 Meetings    BARDA Kick-Off Meeting    Meeting Presentation Materials

 

  1.2.2

Title: Reporting

Objective/Description of Work: Avita will comply with all reporting requirements as outlined and formatted in the RFP and as requested by BARDA. Reporting will include at a minimum monthly progress reports, annual progress reports, annual invention reports, draft final report, and final report. Additional deliverables such as technology packages, experimental protocols, publication, press releases, security reports, or other reports will be provided to BARDA for review prior to initiation of a corresponding work element, deliverable, or FDA submission.

Milestones:

 

  1.2.2.1

Monthly Progress Report – Delivery to and acceptance by BARDA.

 

  1.2.2.2

Annual Progress Report – Delivery to and acceptance by BARDA.

 

  1.2.2.3

Invention Reports – Delivery to and acceptance by BARDA.

 

  1.2.2.4

Draft Final and Final Progress Reports – Delivery to and acceptance by BARDA.

Deliverables:

 

  1.2.2.1

Monthly Progress Report –A report detailing the prior month’s activities and activities planned for the following month. Report will be delivered prior to the 15th of the month following the reporting period.

 

  1.2.2.2

Annual Progress Report –A report summarizing the activities of the period of performance and the activities planned for the upcoming period. Report will be delivered prior to the 30th of the month following the reporting period.

 

  1.2.2.3

Annual/Final Invention Report A report detailing any intellectual property developed as a result of the work performed during each period of performance and the entire contract period. Report will be delivered in conjunction with the annual progress report.

 

  1.2.2.4

Draft Final and Final Progress Report – The Final Progress Report will include a complete summary of all work performed during the entire contract period of performance. A Draft Final Progress Report will be delivered 45 days prior to contract expiration for BARDA review and comments. A Final Progress Report will be delivered prior to 30 days following contract expiration.

 

  1.2.3

Title: Meetings

Objective/Description of Work: Avita and BARDA will engage in regular meetings to coordinate and review project activities. Meetings will be both face-to-face and teleconference/video conference. The first official meeting will be the face-to-face kick-off meeting, followed by status update meetings on a biweekly/monthly basis, ad hoc teleconferences and site visits, and annual meetings to report on the period of performance activities.

 

 

 

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Milestones:

 

  1.2.3.1

Kickoff Meeting with BARDA – The contract is awarded and a face-to-face kickoff meeting is conducted within 30 days of award date.

Deliverables:

 

  1.2.3.2

Kickoff Meeting Presentation Materials –Avita will prepare all necessary presentation materials for the kickoff meeting.

 

  1.4

IMS and EVM

 

WBS# and Title

  

Milestone

  

Deliverable

1.4.2 Performance Measurement Baseline    Performance Measurement Baseline Review (PMBR)    All required components for the PMBR
1.4.3 Integrated Master Schedule    PMBR    Integrated Master Schedule
1.4.4 Monthly Earned Value Performance Report    Delivery to and acceptance by BARDA    Monthly Earned Value Performance Report
1.4.5 Supplemental monthly CAP report    Delivery to and acceptance by BARDA    Supplemental monthly CAP report

 

  1.4.2

Title: Performance Measurement Baseline

Objective/Description of Work: The Performance Measurement Baseline will provide a master schedule of deliverables, costs, and milestones in order to completely cover all items in the SOW. All required components will be submitted to BARDA within 90 days of contract award. BARDA and Avita will mutually agree on the budget, schedule and technical plan baselines as a result of the PMBR.

Milestones:

 

  1.4.2

Performance Measurement Baseline Review – The PMBR plan is submitted and reviewed by BARDA.

Deliverables:

 

  1.4.2

Performance Measurement Baseline Review Plan and Required Components – A plan detailing a schedule of deliverables, costs, milestones, and risks that will serve as the basis for measuring project progress.

 

  1.4.3

Title: Integrated Master Schedule (IMS)

Objective/Description of Work: The NS will be used to monitor performance of the contract. Avita will develop an IMS in a format approved by BARDA in order to track key milestones, Go/No Go decision gates. The IMS will contain baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. Avita will provide a baseline IMS for the PMBR and monthly updates thereafter.

Milestones:

 

  1.4.2

Integrated Master Schedule is approved by BARDA.

 

 

 

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Deliverables:

 

  1.4.3

Integrated Master Schedule – Provided for the PMBR and monthly in order to monitor performance of the contract. The IMS shall be provided at the work package level in MS Project file format.

 

  1.4.4

Title: Monthly Earned Value Performance Report

Objective/Description of Work: The Monthly Earned Value Performance Report will be generated from Avita’s EVMS in order to track any project variances against the baseline. The report will contain technical, schedule, and cost status information in order to identify any issues that may impact project progress and/or cost.

Milestones:

 

  1.4.4

Monthly Earned Value Performance Report – Delivery to and acceptance by BARDA.

Deliverables:

 

  1.4.4

Monthly Earned Value Performance Report – Provided monthly to track project progress according to WBS and EV variance.

 

  1.4.5

Title: Supplemental Monthly CAP Report

Objective/Description of Work: The Supplemental Monthly CAP Report will be generated from Avita’s EVMS and will contain cost information to report on the time phased budget, earned value, and actual costs of work performed. The report will be submitted monthly to BARDA for review.

Milestones:

 

  1.4.5

Supplemental Monthly CAP Report – Delivery to and acceptance by BARDA.

Deliverables:

 

  1.4.5

Supplemental Monthly CAP Report – Provided monthly to detail time phased budget, earned value, and actual costs of work performed as captured by Avita’s EVM systems.

 

2.

Non-Clinical Objectives

 

2.1

Efficacy and Safety

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001A      
2.1.1.1 Updated training resources for mass casualty    Effective training for mass casualty event.    Updated user training documentation
2.1.2 Biocompatibility review    Biocompatibility review complete    Biocompatibility Review Report
2.1.3 Human Factors    FDA requests human factors studies    Human factors studies submitted to FDA
2.1.4 FDA-compliant design documentation    Completion of backup documentation for PMA module 1.    QSR-mandated design control documents and supporting lab test results
2.1.5 Compassionate Use IDE    Deliver to BARDA the annual IDE report on Compassionate Use.    Annual IDE report on Compassionate Use.

 

 

 

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WBS# and Title

  

Milestone

  

Deliverable

CLIN0001A      
2.1.6.1 Continued Access IDE 13053    Deliver to BARDA the clinical trial protocol (CTP) on Continued Access.    Clinical trial protocol (CTP) on Continued Access.
2.1.6.2 Annual IDE Report    Deliver to BARDA the Annual IDE reports    Annual IDE reports
2.1.6.3 Final Clinical Study Report    Deliver to BARDA the Final Clinical Study Report    Final Clinical Study Report
2.1.7 Burn Center Reimbursement educational materials    Deliver to BARDA the Guidance materials on reimbursement.    Guidance materials on reimbursement.
2.1.8.1 Kick-off Meeting & Project Management    Complete Kick-off Meeting    MS PowerPoint presentation outlining understanding of goals, objectives, anticipated approach, and project deliverables, milestones, and timeline.
2.1.8.2 Targeted Literature Search    Complete Literature Search    Draft and final literature review search strategy in MS Word
2.1.8.3 Focusing goals    Complete Briefing which defines focus of goals    A brief MS PowerPoint presentation outlining options for the model framework
2.1.8.4 Model Storyboard    Completion of Model Storyboard    Draft and revised model storyboards (MS PowerPoint).
2.1.8.5 KOL Engagement    Complete Recruitment of KOL’s    KOL recruitment and management (for 3 KOLs), draft and final KOL summary feedback (Word) for all KOL meetings, final storyboard (MS PowerPoint). KOL’s to be approved by BARDA.
2.1.8.6 Preliminary Model Programming and Results    Complete Preliminary Model    Preliminary model (MS Excel 2013 file for PC) and a presentation of preliminary findings in a MS PowerPoint slide deck to be shared with BARDA via WebEx or during an in-person meeting.
2.1.8.7 Final Model    Complete Final Model    Final model version (in MS Excel) and final results slides (in MS PowerPoint); quality assurance documentation (MS Word) can be made available upon request.
2.1.8.8 Technical Reporting    Complete Final Technical Report    Two drafts and a final version of a written technical report (MS Word).

 

  2.1.1.1

Title: Updated training resources for mass casualty

Objective/Description of Work: Existing training manuals for use of the ReCell device are designed for a clinical/surgical setting by experienced clinicians. Led by the Director of Education, with support from the Education Specialist, Avita will develop a new training protocol sufficient for a mass casualty event for ReCell to be used by minimally trained personnel that may or may not have burn surgery experience. Target goal will be a one-hour training session to personnel at a trained medic level or higher. New training materials will be submitted to BARDA for review/feedback and then finalized.

 

 

 

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Milestones:

 

  2.1.1

Creation of training materials, including video, workshop/online course materials, reference guides, as determined in collaboration with BARDA

Deliverables:

 

  2.1.1.1

Training materials as determined in collaboration with BARDA.

 

  2.1.2

Title: Biocompatibility review complete

Objective/Description of Work: Full biocompatibility is demonstrated for EU and Australia, to ISO standards. The testing work needs to be done to US FDA standards. Results of biocompatibility review will be submitted to BARDA for review/feedback.

Milestones:

 

  2.1.2

Biocompatibility submitted to FDA

Deliverables:

 

  2.1.2

Biocompatibility Review Report draft and final report submitted. to BARDA and final report submitted to FDA

 

  2.1.3

Title: Human Factors

Objective/Description of Work: Avita will conduct an evaluation to ensure that the ReCell devices meet usability guidelines when used by the intended user population. Avita will conduct all required studies and submit the results to BARDA for review and feedback. Upon BARDA approval, Avita will submit report to FDA.

Milestones:

 

  2.1.3

Requested data/report submitted to FDA

Deliverables:

 

  2.1.3

As requested by FDA, human factors draft and final reports submitted to BARDA and final data and report submitted to FDA

 

  2.1.4

Title: FDA-Compliant Design Documentation

Objective/Description of Work: Avita’s recent gap analysis for PMA module 1 readiness indicates that in addition to biocompatibility testing Avita will need to create an FDA QSR-compliant design control document package, including backup lab test data and reports, including packaging testing. Avita will provide the various reports to BARDA, as requested, for review and approval prior to sending to FDA.

Milestones:

 

  2.1.4.1

Functional Testing Complete

 

  2.1.4.2

Packaging/Shipping Testing Complete

 

  2.1.4.3

EMI/EMC Testing Complete

 

 

 

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  2.2

Non-clinical data sufficient for PMA module 1 of 1

Deliverables:

 

  2.1.4

QSR-mandated design control documents and supporting lab test results –Avita will generate a design control document package that will meet current FDA requirements, in support of PMA module 1 of 1

 

  2.1.5

Title: Compassionate Use IDE 15945

Objective/Description of Work: Avita’s Compassionate Use IDE provides a mechanism for surgeon access to ReCell as an investigational device, for patients presenting with life-threatening injuries for which there is insufficient donor skin for conventional autograft treatment. Requests, along with a letter of support, are evaluated for suitability and patients are approved by Avita on a case by case basis. Surgeons may request Compassionate Use regardless of their prior experience with ReCell and independent from their site’s participation in IDE 13053 for the study of burns). The Compassionate Use IDE provides for further experience in the use of ReCell, toward fulfilment of BARDA’s objective of familiarity/acceptance in US burn centers. Avita personnel travel to support these surgeries, and a 3`d-party CRO and an independent consultant are contracted to perform clinical monitoring for compliance with Good Clinical Practice. In-house regulatory personnel will draft associated regulatory submissions.

Milestones:

 

  2.1.5

Deliver to BARDA the annual IDE report on Compassionate Use.

Deliverables:

 

  2.1.5

Annual IDE report on Compassionate Use.

 

  2.1.6

Title: Continued Access IDE 13053

Objective/Description of Work: FDA may allow continued enrollment of subjects after the controlled clinical trial under an IDE has been completed in order to allow access to the investigational medical device while the marketing application is being prepared by the sponsor or reviewed by FDA. Under this policy, a sponsor may propose to conduct an “extended” clinical trial if: 1) there is a public health need for the device and 2) there is preliminary evidence that the device is likely to be effective and no significant safety concerns have been identified for the proposed indication. Avita will submit CTP001-7 to the FDA to allow Continued Access of ReCell at up to 15 clinical sites for treatment of up to an additional 100 patients. As with Compassionate Use, this positions the US burn centers to be more effective in the event of a mass casualty. Onsite training of burn centers will be required, and a 3rd-party CRO will be contracted for clinical project management, clinical data management and clinical monitoring, for compliance with IDE requirements.

Milestones:

 

  2.1.6.1

Continued Access IDE 13053 – Delivered to BARDA

 

  2.1.6.2

Annual IDE Report Delivered to BARDA

 

  2.1.6.3

Final Clinical Study Report – Delivered to BARDA

 

 

 

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Deliverables:

 

  2.1.6.1

Continued Access IDE 13053 Report

 

  2.1.6.2

Annual IDE Report

 

  2.1.6.3

Final Clinical Study Report

 

  2.1.7

Title: Reimbursement

 

WBS# and Title

  

Deliverable

CLIN0001A
2.1.7 Burn Center Reimbursement educational materials    Guidance materials on reimbursement.

Objective/Description of Work: Reimbursement coding is central to establishing familiarity and acceptance of a new product in healthcare. Avita will hire a Reimbursement Manager to establish coding mechanism(s) for ReCell, and this information will be integrated into the educational material provided to burn centers. The support of expert consulting is also anticipated.

Milestones:

 

  2.1.7

Guidance materials on reimbursement – Delivered to BARDA

Deliverables:

 

  2.1.7

Guidance materials on reimbursement

 

  2.1.8

Title: Modeling the Economic Benefits of Medical Countermeasures

Objective/Description of Work: Avita will work with a Subject Matter expert to develop a generic model for cost and economic impact in burn care with introduction of ReCell technology as a candidate for evaluation, both at the single-center level, and a multi-center (commercial) use. The model (aka tool) will allow for evaluation of cost impact on burn care from use of specific products as well as broader economic impact. The tool is expected to be self-standing and include access to other required information such as databases necessary for full functionality and use of the software. Other features of the model will include:

 

  a.

A comprehensive review of parameters which influence the integrated cost impact on burn care (and broader economic impact) both directly or indirectly would be identified and evaluated. Such parameters may include but are not limited to impact of resources (surgical and non-surgical) personnel time, material resources as well tangible changes to the clinical outcomes (example, length of hospital stay or ICU days). Impact of product launch pricing models and potential market share over time may also be included in the tool.

 

  b.

The tool will be designed to predict costs and benefits associated with the care of burn patients based on (i) specifiable characteristics of a hypothetical group of patients (e.g. in terms of burn severity, number of patients, etc) and (ii) modeled changes to fundamental cost drivers associated with particular changes in practice as a result of introduction of the new product and associated downstream impact. As such, the financial and economic impact of introduction of medical countermeasures, alone and in combination, may become predictable.

 

 

 

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  c.

Avita will test the tool with available data and assumptions and iteratively develop in consultation with the experts to refine the model using ReCell data as well as to ensure the generic nature of the cost and economic Impact tool.

 

  d.

For this effort it is recognized that definitive burn care is typically provided over time and that care treatments/procedures change as burn etiology evolves. This has allowed for identification of distinct treatment areas within the definitive care continuum. New products (such as Avita’s ReCell) directed at such treatment targets are expected to have an impact on the cost effectiveness of burn care, which represents the over-arching scope of this effort.

 

  e.

For the sake of comprehensive analysis under this effort, an exhaustive list of parameters (preferably ranked) shall be identified and qualified to be measurable within the following treatment targets in the continuum of definitive care: (1) debridement, (2) application of skin substitutes (which eliminate autografting), (3) autograft sparing technology, and (4) adjuncts to enhance/accelerate healing.

 

  f.

The overall capability of the tool is to capture the key parameters across this continuum wherein impact of any new products altering these key parameters within a treatment area, objectively demonstrates a clear, measurable value proposition (or a lack thereof) in the overall cost effectiveness and other attributes. The tool would also feature an ability to be customized either by turning on or off the key parameters or add a user chosen parameter, based on relevance to target area.

 

  g.

Based upon a competitive selection process between three potential SME’s, [**] is the primary candidate for this project. A designated panel of experts should be accessible.

 

  2.1.8.1

Title: Kick-off Meeting & Project Management

Objective/Description of Work: A Kick-off meeting will be conducted to:

 

   

Introduce the project team members

 

   

Discuss KOL selection process;

 

   

Review and confirm the goals of the project;

 

   

Finalize the approach to the project phases; and

 

   

Review anticipated project deliverables, milestones and timelines (Gantt chart).

Milestones:

 

  2.1.8.1

Complete Kick-off Meeting

Deliverable:

 

  2.1.8.1

MS PowerPoint presentation outlining understanding of goals, objectives, anticipated approach, and project deliverables, milestones, and timeline.

 

  2.1.8.2

Title: Targeted Literature Search

Objective/Description of Work: Develop literature search strategy and obtain agreement with BARDA. Perform literature search and report on results.

Milestones:

 

  2.1.8.2

Complete Literature Search

 

 

 

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Deliverable:

 

  2.1.8.2

Draft and final literature review search strategy in MS Word.

 

  2.1.8.3

Title: Focusing goals

Objective/Description of Work: Compile a preliminary burn care model structure and identify any key points that may require discussion and agreement between project participants. Develop a discussion deck (in MS PPT) that outlines options for the model framework, including a detailed proposed structure. The deck will be used to facilitate an interactive discussion with BARDA.

Milestones:

 

  2.1.8.3

Complete Briefing which defines focus of goals

Deliverable:

 

  2.1.8.3

A brief MS PowerPoint presentation outlining options for the model framework and structure to facilitate discussion; appended summary of action items.

 

  2.1.8.4

Title: Model Storyboard

Objective/Description of Work: Develop a Model Storyboard, which is a detailed plan for the model, intended to provide an opportunity for discussion and agreement with BARDA, prior to programming. This storyboard will include the model structure to facilitate cost-effectiveness and budget impact assessments, detailed parameter types (including all clinical inputs and costs), with referenced default values for all variables, as well as model user-functionality and model outputs.

Although this model will be developed to have a generic structure, the storyboard and model development will be performed to permit evaluation of Avita’s ReCell technology. One primary comparator (e.g. a standard autograft procedure) will serve as the base case for the cost-effectiveness evaluation, and will focus the storyboard accordingly with detailed input values around ReCell and the base case comparator. The model will be developed to include up to three (3) dummy comparators to permit exploration of additional interventions at points along the burn care pathway, but data specific to these hypothetical interventions will not be included in the storyboard or analyses. Because the US model may be used in discussions with different types of stakeholders, it is anticipated that the storyboard will include information to inform different perspectives, including hospital perspective, payer perspective, and at BARDA’s option, societal perspective. Differences between these may include time horizon (shorter term for hospital perspective) and cost inputs. It is assumed that budget impact calculations will rely on the same underlying structure and inputs as are used for the cost- effectiveness model, and thus gain efficiencies between the two analysis types. However, pricing predictions, market uptake assumptions and market share distribution will be required from marketing research. Any additional detailed clinical and cost input values not available from other sources may be solicited from KOLs (e.g. likely resource use assumptions); based on discussion with KOLs, however, a survey or database analysis Optional Task may be desired to obtain the best possible data.

 

 

 

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After presentation of the storyboard to BARDA, comments received during this meeting and any additional consolidated comments received in the following week will be incorporated into a storyboard revision. Input from all internal stakeholders at this phase will ensure the model contains the appropriate elements and addresses key considerations. This revision will serve as the platform for the first KOL engagement.

Milestones:

 

  2.1.8.4

Completion of Model Storyboard

Deliverable:

 

  2.1.8.4

Draft and revised model storyboards (MS PowerPoint).

 

  2.1.8.5

Title: KOL Engagement

Objective/Description of Work: Engage three KOLs for the following:

 

   

One hour each for a meeting to collect feedback on the proposed model storyboard;

 

   

One additional hour each to help fill any key model data gaps (e.g. providing resource use assumptions);

 

   

A two-hour advisory panel (joint meeting) for a discussion of the preliminary model and results. (At Avita’s option, this may be redefined as a half-day advisory board with KOLs and all project participants. Please see Optional Tasks.)

Engage with the KOLs via teleconference, utilizing presentation materials generated during other project tasks, including the storyboard and preliminary model results presentation. Provide a short written summary of meeting minutes and implications for analysis following ach discussion. Following one round of review, the summary of feedback (meeting minutes) document will be considered final, and details will be incorporated into a final version of the storyboard.

The budget assumes [**] US-based KOLs. Payment of honoraria will be contracted in accordance with Avita governance procedures. Any fees paid by will be considered as pass-through costs to BARDA and will be clearly reported and documented.

Milestones:

 

  2.1.8.5

Complete Recruitment of KOL’s

Deliverable:

 

  2.1.8.5

KOL recruitment and management (for [**] KOLs), draft and final KOL summary feedback (Word) for all KOL meetings, final storyboard (MS PowerPoint). KOL’s to be approved by BARDA

 

  2.1.8.6

Title: Preliminary Model Programming and Results

Objective/Description of Work: Initiate programming the model for use on a PC platform with MS Excel 2013. Populate the model with parameter estimates, and use the model to generate preliminary estimates of the cost- effectiveness of using ReCell technology vs a chosen appropriate comparator available perspectives (e.g. hospital, payer, and

 

 

 

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(optional) US society), and of the budget impact of adding ReCell to the available burn care therapies. Include up to [**] dummy comparators into the model (one for each phase of the burn care pathway) to permit evaluation of the impact of other therapeutic options. Model programming will also include a univariate sensitivity analysis function to identify the most sensitive parameters in the model, displayed as a tornado diagram for convenient interpretation and reporting.

At this stage, Avita will outline preliminary model results, and will present the draft results to BARDA to obtain internal feedback, and also deliver the preliminary model to ensure transparency.

After collecting initial feedback from BARDA, engage the [**] KOLs in a single 2-hour meeting for collective review and validation.

Milestones:

 

  2.1.8.6

Complete Preliminary Model

Deliverable:

 

  2.1.8.6

Preliminary model (MS Excel 2013 file for PC) and a presentation of preliminary findings in a MS PowerPoint slide deck to be shared with Avita via WebEx or during an in-person meeting.

 

  2.1.8.7

Title: Final Model

Objective/Description of Work: Develop the final version of the model and update the preliminary results slides with final results to be shared with BARDA via WebEx or during an in-person meeting. The model will be developed for two US perspectives, and at BARDA’s option, may include a third. The scope of work assumes that the costing model will contain two perspectives (hospital, payer), and one primary comparator to ReCell (e.g. standard of care autografting), with dummy structure for [**] additional comparators (i.e. intervention-specific data will not be prepopulated for these dummies).

Milestones:

 

  2.1.8.7

Complete Final Model

Deliverable:

 

  2.1.8.7

Final model version (in MS Excel) and final results slides (in MS PowerPoint); quality assurance documentation (MS Word) can be made available upon request.

 

  2.1.8.8

Title: Technical Reporting

Objective/Description of Work: Prepare a written report which includes a description of the project objectives, methods (including structure, referenced parameter values, and analytic outcomes), results, and concluding summary of the results (520 pages).

Milestones:

 

  2.1.8.8

Complete Final Technical Report

Deliverable:

 

  2.1.8.8

Two drafts and a final version of a written technical report (MS Word).

 

 

 

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  2.1.8.9

Title: Optional Supplemental Project Tasks

Objective/Description of Work: The following is a list of representative tasks that may be required. This task list may be modified and/or supplemented in accordance with written direction and approval from BARDA.

 

   

Option 1: Abstract and poster

 

   

Option 2: Scientific manuscript

 

   

Option 3: Adding societal perspective to the model

 

   

Option 4: Expert survey to obtain missing data

 

   

Option 5: Database analysis to obtain missing data

 

   

Option 6: Half-Day advisory board to review and discuss preliminary model

 

   

Option 7: Dynamic summary report

 

   

Option 8: iPad tool adaptation

 

   

Option 9: Bank of Hours to Support Scope Amendments

 

   

Option 10: Detailed Analysis of Patient Level Data:

 

   

Analysis will include ICD codes (such as under ICD9, 10 ),HCPCS code-Level data, CPT code-Level data, Revenue code-Level data and other data sources such as the Healthcare Blue Book. These data can be used to assess data provided by providers on resource use (hospital LOS, frequency of dressing changes, use of diagnostics and disposables, blood transfusions, escharotomies, autografting, etc.) at each stage in the treatment timeline (debridement, autografting, etc.)

 

  2.3

Stability and Review of Extended Shelf Life

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
2.3.1 Stability Plan    Expiration limiting components identified and plan developed to extend to 4-year target    Stability Plan
2.3.6 Stability Report (accelerated aging)    Accelerated aging testing results complete    Stability report
2.3.7 Stability report (real- time aging)    Real-time aging testing results complete    Stability report
2.3.8 Review of extended shelf life    New expiry limits determined    Results report submitted to BARDA
2.3.9 Revisions to labeling    Stability extension submission    Shelf life report and revised labeling submitted to FDA

 

  2.3.1

Title: Stability Plan

Objective/Description of Work: Avita will develop a stability plan that will outline the testing necessary to extend the shelf life of the ReCell unit to 4 years in order to minimize product losses due to expiry. Avita will focus on specific expiration-limiting components (enzyme and buffer, RPU, and nozzle). Avita will design and execute on a stability testing plan to verify stability for extension of shelf life. Reports will be submitted to BARDA detailing the shelf life of ReCell units. Labeling will be modified based on new expiries and submitted to FDA to approval.

 

 

 

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Milestones:

 

  2.3.1

Expiration limiting components are identified and a plan is developed to extend ReCell unit to a target of 4-year expiry.

Deliverables:

 

  2.3.1

Stability plan outlining all necessary real-time and accelerated aging testing required to justify expiry.

 

  2.3.6

Title: Stability Report (accelerated aging)

Objective/Description of Work: Following accelerated aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.6

Stability testing results complete.

Deliverables:

 

  2.3.6

Stability report detailing product performance for ReCell components after aging

 

  2.3.7

Title: Stability Report (real-time aging)

Objective/Description of Work: Following real-time aging testing, a report will be prepared outlining the product performance. The report will detail whether expiry targets were achieved. If targets were not achieved, a plan will be provided detailing further modifications or a plan for acceptance of a new expiry target. Avita will submit to BARDA for review and comments.

Milestones:

 

  2.3.7

Stability testing results complete.

Deliverables:

 

  2.3.7

Stability report detailing aged performance for ReCell components

 

  2.3.8

Title: Review of extended shelf life

Objective/Description of Work: Avita will prepare a report for BARDA detailing the changes product shelf life. Avita will report on the plan for accordingly revised product labeling to be submitted to FDA.

Milestones:

 

  2.3.8

Delivery of report of extended shelf life

Deliverables:

 

  2.3.8

Shelf life report delivered to BARDA for review, followed by a report detailing plans for FDA submission, and implications for the VMI.

 

  2.3.9

Title: Revisions to labeling

Objective/Description of Work: Avita will revised the product labeling to reflect new shelf life parameters, and will submit to FDA.

 

 

 

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Milestones:

 

  2.3.9

FDA approval of revised product labeling

Deliverables:

 

  2.3.9

New product labeling and FDA submission for review/approval of new product labeling.

 

3

Clinical

 

  3.1

Pivotal Clinical Trials

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
3.1.1.4 Clinical Study Report    CTP001-5 Clinical Study Report (CSR), review complete    CTP001-5 Clinical Study Report (CSR), review/submit to FDA
3.1.2.6.1 Statistical Analysis (9mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.2 Clinical Study Report (9mo)    CTP001-6 Initial (9- months) CSR complete    CTP001-6 Initial (9-months) CSR, review (PMA module 3 of 3)
3.1.2.6.4 Statistical Analysis (12mo)    Statistical analysis complete    CTP001-6 Tables, Listings & Figures (i.e. Statistical analysis output)
3.1.2.6.5 Clinical Study Report (12mo)    CTP001-6 Final (12- months) CSR complete    CTP001-6 Final (12-months) CSR, review

 

  3.1.2.8

Title: Final CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Pivotal Clinical Trials encompass two ongoing clinical protocols: CTP001-5 (deep partial-thickness) and CTP001-6 (mixed depth including full-thickness). Both studies show definitive closure using less donor skin with ReCell as compared to standard care, and are also looking at long-term scar outcomes. The clinical study report (CSR) from CTP001-6 is the primary component of PMA module 3 of 3. All CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.1.1.1

Last subject last visit for CTP001-5 (complete)

 

  3.1.1.4

Clinical Study Report complete for CTP001-5

 

  3.1.2.1.1

FDA Statistical Analysis Plan submitted and approved by FDA for CTP001-6 (complete)

 

  3.1.2.3.2

Last subject last visit for CTP001-6

 

  3.1.2.6.4

CRO completes 9-month statistical analysis for PMA module 3 of 3.

 

  3.1.2.8

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.1.1.4

CTP001-5 Clinical Study Report (CSR)

 

  3.1.2.6.1

CTP001-6 9-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.2

CTP001-6 Initial (9-months) CSR (for PMA module 3 of 3)

 

  3.1.2.6.4

CTP001-6 12-month Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.1.2.6.5

CTP001-6 Final (12-months) CSR

 

 

 

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4

Regulatory

 

  4.1

Pre-Emergency Use Authorization

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
4.1 Pre-Emergency Use Authorization    Avita completes all submissions needed for EUA    All data requested by BARDA to obtain pre-EUA

 

  4.1

Title: Pre-Emergency Use Authorization

Objective/Description of Work: Avita will support BARDA/HHS in obtaining a Pre-Emergency Use Authorization for the ReCell device. All required studies, reviews, reports, and analyses will be provided as requested.

Milestones:

 

  4.1

Avita completes all submissions needed for EUA

Deliverables:

 

  4.1

Submission to BARDA/HHS of all required materials needed for Pre-EUA.

 

  4.2

Premarket Approval (PMA)

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
4.2.2.1.4 Module 1 Submission    Module 1 package assembled    Module 1 package to FDA
4.2.2.2.4 Module 2 Submission    Module 2 package assembled    Module 2 package to FDA
4.2.2.3.4 Module 3 Submission    Module 3 package assembled    Module 3 package to FDA
4.2.2.5.3 Create action plan to address panel recommendations    FDA Panel Meeting    Action Plan

 

  4.2.2.1.4

Title: Module 1 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package with modular submissions for FDA review and approval. The PMA package will consist of three PMA modules. Module 1 will focus on non-clinical data.

Milestones:

 

  4.2.2.1.4

Module 1 package assembled

Deliverables:

 

  4.2.2.1.4

Module 1 submission to FDA – Module 1 includes biocompatibility, human factors, shipping/packaging validation, EMI/EMC, and all other required non-clinical data.

 

  4.2.2.2.4

Title: Module 2 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 2 will focus on manufacturing data.

 

 

 

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Milestones:

 

  4.2.2.2.4

Module 2 package assembled

Deliverables:

 

  4.2.2.2.4

Module 2 submission to FDA – Submission will include the principles of operation, quality system and manufacturing documentation, sterilization, shelf-life information, and packaging information.

 

  4.2.2.3.4

Title: Module 3 PMA Submission

Objective/Description of Work: Avita will prepare a complete PMA package for FDA approval. The PMA package will consist of three PMA modules. Module 3 will focus on clinical data. Module 3 will be submitted to BARDA for review and approval, followed by submission to FDA.

Milestone:

 

  4.2.2.3.4

Module 3 package assembled and approved by BARDA

Deliverables:

 

  4.2.2.3.4

Module 3 submission to FDA – Submission will include the CTP001-6 clinical data labels and manuals, draft post-marketing plan (CoA study protocol) and bibliography.

 

  4.3

Title: BIMO Mock Audit and Enhanced in-house support of the PMA Pathway

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001      
4.3.1    Complete Remediation of Trial Master Files    Submit BIMO Mock Audit Report and remedial action plan.

Objective/Description of Work: Prepare for and execute a BIMO Mock Audit to review the Trial Master Files (TMF) at Avita and to audit the site files of three selected burn centers participating in IDE 13053. Avita will subsequently prepare a remedial action plan, and then correct deficiencies as identified by the mock auditing. The status of the remediation activity will be reported in Avita’s monthly progress report to BARDA. Ensure availability of in-house regulatory, quality, engineering and manufacturing subject matter experts to respond to the following:

 

   

Clinical and non-clinical data questions, findings, deficiencies & remediation.

 

   

Technical and regulatory questions from BARDA and FDA in response to Avita’s submission of documents and reports.

 

   

Implementation of design and manufacturing change requests and process improvements as a result of review and feedback.

Milestone:

 

  4.3.1

Complete Remediation of Trial Master Files

Deliverables:

 

  4.3.1

Submit BIMO Mock Audit Report and remedial action plan.

 

 

 

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5

Product Development for mass casualty/VMI

 

  5.1

Requirement Gathering, 5.2 Product Design, 5.3 Systems Requirements and Design Review, and 5.4 CDC Quality Agreement

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
5.3 Systems Requirements (VMI optimization) and Design Review    Review of VMI optimized product design package complete    Product optimized for VMI Design Package
5.4 CDC Quality Agreement    Executed CDC Quality Agreement    CDC Quality Agreement

 

  5.3, 5.4

Title: Systems Requirements (VMI optimization) and Design Review

Objective/Description of Work: In order to develop a product ready for manufacturing and stockpiling, Avita will work with BARDA to first gather the requirements for DFM/DFA, inventory management and any other requirements. Based on the requirements, Avita will initiate Product Design to all ensure the product will meet specifications. This includes design and review for any changed or affected part: Components, Subassembly, Product System, and Packaging Design. Document package will be sent to BARDA for review. Avita will work with CDC to establish a quality agreement, if required.

Milestones:

 

  5.1

Requirements document compiled from BARDA

 

  5.2.1.2

Component Design Review complete

 

  5.2.2.2

Subassembly Design Review complete

 

  5.2.3.2

Product System Design Review complete

 

  5.2.4.2

Packaging Design Review complete

 

  5.3

Full systems requirements and design review complete and approved by BARDA

 

  5.4

If required, establish quality agreement with CDC for supporting VMI

Deliverables:

 

  5.3

System Requirements and Design Review – A system requirements and design review report will be submitted to BARDA containing the requirements and the design changes made to meet those requirements.

 

  5.4

Agreed upon CDC quality agreement for supporting VMI (if required)

 

  5.5

Verification and Validation

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
5.5 Verification and Validation Report    V&V verifies product meets specifications and requirements    V&V Report

 

  5.5

Title: Verification and Validation Report

Objective/Description of Work: Verification & Validation are used to verify that the product meets the specifications and requirements and address the intended purpose. Verification demonstrates that the product meets specification and Validation demonstrates fitness of use for the intended purpose. Once V&V results are positive, the product is ready to release to manufacturing. Avita will submit a report to BARDA detailing the results of the V&V analysis.

 

 

 

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Milestones:

 

  5.5

Testing and analysis indicate that the product meets specification and intended purpose.

Deliverables:

 

  5.5

V&V Report - Avita will submit a report to BARDA detailing the results of the V&V analysis.

 

6

QSR

 

  6.1

Quality System Preparedness

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
6.1.3 3rd Party Audit    Audit completed    QSR Audit Report

 

  6.1.3

Title: 3rd Party Audit

Objective/Description of Work: The US FDA Quality System Regulation (QSR) describes the environment under which medical device firms must operate. This task involves preparing the Avita quality systems for FDA review and inspection, and verifying compliance with FDA requirements. Avita hired an external 3rd party auditor to complete a QSR gap analysis. Following the audit a gap assessment was prepared and presented to Avita from the 3rd party auditor. Avita will develop a Gap Corrective Action plan to address any gaps identified. This will support PMA submission. Once the corrective action plan has been implemented and changes are in place a mock audit will be performed by a 3rd party auditor in preparation for an expected FDA inspection during PMA review.

Milestones:

 

  6.1.1

Gap Assessment

 

  6.1.2

Gap corrective action performed and all systems brought into compliance

 

  6.1.3

Mock QSR audit

Deliverables:

 

  6.1.3

QSR 3rd Party Audit Report - Avita will submit a report to BARDA detailing the results of the final QSR audit.

 

  6.2

Commercial Manufacturing

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0001
6.2.1. Commercialization Plan and Gap Analysis    Completion of commercialization plans    Final Commercialization Plan
6.2.2.4 Validation Report    IQ/OQ/PQ process validations complete    Validation Report

 

  6.2.1

Title: Commercialization Plan and Gap Analysis

Objective/Description of Work: Perform a gap analysis to assess commercialization readiness and draft a commercialization plan in support of market entry. Tasks include, as necessary, establishing SKU#, Supply chain and vendor qualifications, raw material inventory, sterilization, packaging, and labeling, and lot release.

 

 

 

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Milestones:

 

  6.2.1.1

Commercialization Gap Assessment completed

 

  6.2.1.2

Commercialization Plan Draft created, reviewed with BARDA

 

  6.2.1.3

Commercialization Plan finalized.

Deliverables:

 

  6.2.1.1

Commercialization Gap Assessment Report

 

  6.2.1.2

Commercialization Plan draft and final versions reviewed and submitted to BARDA.

 

  6.2.2.4

Title: Validation Report

Objective/Description of Work: Process validation involves the collection and evaluation of data from the processes used to produce the product. Avita’s commercial manufacturer will lead the effort in manufacturing, under close supervision and collaboration with Avita. Sterile packaging will be a primary focus of the validation effort to ensure repeatable package integrity and valid sterilization processes. Process validations will include 10/0Q/PQ and final validation. Avita will present a final report detailing the results of the validation analysis.

Milestones:

 

  6.2.2.1

IQ, Installation Qualification complete

 

  6.2.2.2

OQ, Operation Qualification complete

 

  6.2.2.3

PQ, Process Qualification complete

Deliverables:

 

  6.2.2.4

Validation Report - Avita will submit a report to BARDA detailing the results of the process validation analysis.

CLIN 0002 – Base Period

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0002
7.1.1.2 Product Manufacturing    Order Received    Initial Product
7.1.1.3 Deploy product to VMI sites    Product shipped to sites    Product deployed

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: Upon authorization from BARDA, Avita will cause the production and delivery of ReCell devices. Upon receiving the order Avita will authorize the manufacturer to procure supplies for the manufacture of the devices and preparing designated inventory locations.

Milestones:

 

  7.1.1.1

Order Received

 

  7.1.1.2

Delivery of specified quantity of units to VMI.

 

 

 

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Deliverables:

 

  7.1.1.2

Initial Product Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices.

 

  7.1.1.3

Product integrated into VMI and available for deployment

 

  7.2.1

Title: Gather VMI Requirements

Objective/Description of Work: Avita will work with USG to identify all VMI requirements, and prepare a document detailing the requirements.

Milestones:

 

  7.2.1

All VMI requirements agreed upon with BARDA

Deliverables:

 

  7.2.1

VMI Requirements Document – Report detailing the agreed upon requirements for VMI.

 

  7.4

Sustainment/Stockpile Management

 

WBS# and Title

  

Milestone

  

Deliverable

CLIN0002
7.4.1 Inventory Management    Quarterly inventory reports    Inventory Management Report

 

  7.4.1

Title: inventory Management

Objective/Description of Work: Inventory management encompasses activities that occur after the inventory is on site and the inventory system is in operation. The purpose is to ensure ongoing compliance with the stockpiling requirements, and manage replenishment to ensure unit availability in emergency situations. Site environments will continue to be monitored through the lifetime of the contract for compliance with environmental requirements, and inventory controls will be followed. Site performance will be monitored periodically, supplemented by BARDA site visits. Plans will be executed to replenish expiring goods and units will be reworked as needed to maintain currency. Avita will present to BARDA Inventory Management Reports detailing the status and activities at all VMI locations at a frequency determined appropriate by BARDA and Avita.

Milestones:

 

  7.4.1

Quarterly inventory reports

Deliverables:

 

  7.4.1

Inventory Management Report

 

 

 

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Avita Medical OPTION SOW

 

Summary Table

 

CLIN

  

WBS 1st
Level
Element

  

Title

  

Objectives

0003    3    CoA Study   

•  Complete Post-Approval (conditions of approval) study, as required by FDA

0004    3, 4    Pediatric Studies   

•  Complete pediatric clinical trials per FDA requirements and BARDA guidance

0005    7    Procurement (Surge)   

•  Execute acquisition contact

 

•  Expand VMI as necessary

 

•  Manage inventory

0006    7    Procurement (Surge)   

•  Execute acquisition contact

 

•  Expand VMI as necessary

 

•  Manage inventory

0007    7    Procurement (Surge)   

•  Execute acquisition contact

 

•  Expand VMI as necessary

 

•  Manage inventory

0008    7    Procurement (Surge)   

•  Execute acquisition contact

 

•  Expand VMI as necessary

 

•  Manage inventory

Overview

Avita has defined three option periods covering the Conditions of Approval (CoA) study after FDA approval of the ReCell Device (CLIN 0003), a Pediatric study to expand the indications for ReCell for a broader pediatric demographic, if necessary, for ReCell (CLIN 0004), and for the procurement of additional ReCell devices beyond the initial acquisition (CLIN0005). Note: Updated SOW(s) will be provided to BARDA based on FDA feedback to support the execution of each CLIN. The accompanying budget(s) will also be updated to align with the revised SOW(s).

The purpose of the CoA, CLIN 0003, is to provide longer-term evaluation of the ReCell device after FDA approval, in order to track and confirm that any post-market commitments are addressed by Avita.

The purpose of the Pediatric Study, CLIN 0004, is to expand the approved range of patients for ReCell, specifically for pediatric patients, beyond those originally approved during the PMA process. The specific study design and objectives will be based on the PMA approval outcomes as well as consultation with BARDA, and will be intended to expand the range of patients able to be treated by ReCell.

Surge acquisition, CLIN 0005, will support additional acquisition of ReCell devices by BARDA, CDC, or other stakeholders.

 

 

 

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CLIN 0003 Option – CoA Study

 

3

Clinical

 

  3.3

Post approval (Condition of Approval Study)

 

WBS# and Title

  

Milestone

  

Deliverable

3.3.1.2 Submit protocol to BARDA for review    Protocol developed    Study Protocol
3.3.6.1 Statistical analysis    Statistical analysis complete    Tables, Listings & Figures (i.e. Statistical analysis output)
3.3.6.2 Clinical study report    CSR complete    CSR, review/submit to FDA

 

  3.3.6.4

Title: Final CoA CSR Review; Sufficiency for FDA submission

Objective/Description of Work: Post approval (COA study) will be carried out if an additional study is required by FDA as a condition of PMA approval. If a COA study is required, a new clinical study will need to be prepared and approved, including protocol with inclusion and exclusion criteria, endpoints, and IDE application written and submitted, FDA approval of the IDE, local IRB approval, clinical study site agreements, and local ethics approvals. The study protocol and all CSR reports, statistical analysis results, and final CSR reviews will be submitted to BARDA for review and comment prior to submitting to FDA.

Milestones:

 

  3.3.1.1

Protocol developed

 

  3.3.2.2

Last subject last visit

 

  3.3.6.1

CRO completes statistical analysis

 

  3.3.6.2

Final CSR review complete and data is determined to be sufficient for FDA submission

Deliverables:

 

  3.3.1.2

Study Protocol submitted to BARDA

 

  3.3.6.1

Tables, Listings & Figures (i.e. Statistical analysis output)

 

  3.3.6.2

CSR, review/submit to FDA

CLIN 0004 – Option – Pediatric Study

Summary Table

 

CLIN

  

WBS 1st
Level
Element

  

Title

  

WBS 2nd
Level
Element

  

Objectives

0004    1    Project Management   

•  1.1

 

•  1.2

 

•  1.4

  

•  Provide Internal Project Management

 

•  Provide Contract Management

 

•  Establish Baseline and provide EV CPR Reports

 

 

 

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CLIN

  

WBS 1st
Level
Element

  

Title

  

WBS 2nd
Level
Element

  

Objectives

   2    Non-Clinical Objectives   

•  2.1

 

•  2.2

 

•  2.3

  

•  Quality Systems Upgrades

 

•  Update the Economic Benefits of Medical Counter Measures Model

 

•  Facilitate ReCell Sustainability through development of a robust commercialization plan

   3    Clinical Objectives   

•  3.1

 

•  3.2

  

•  Pediatric Studies for Expanded Labelling

 

•  Part 1 Donor site treatment in patients aged 1 – 16 years.

 

•  Part 2 Treatment of patients aged 1 – 16 years with partial thickness injuries.

   4    Regulatory Objectives   

•  4.1

  

•  PMA Supplements with expanded labelling for Donor Site Treatment and Pediatric partial thickness injury treatment

 

•  Facilitate FDA Panel Preparation Activities

 

1.

Program Management

 

1.1.

Internal Project Management

 

WBS# and Title

  

Milestone

  

Deliverable

1.1.1 Integrated Master Project Plan    Upon delivery to and acceptance by BARDA    All required elements of this plan as listed in the contract.

 

  1.1.1.

Title: Integrated Master Project Plan

Objective/Description of Work: Avita will compile all necessary materials and finalize all aspects of the project related to preparing the Integrated Master Project Plan. This will include finalizing critical path milestones, Work Breakdown Structure (WBS), and Risk Mitigation Plan. The final deliverable of the IMPP will represent the finalization and approval of all project elements between Avita and BARDA.

 

  1.2

Contract Management

 

WBS# and Title

  

Milestone

  

Deliverable

1.2.2 Reporting    Upon delivery to and acceptance by BARDA    All required reports as listed in the RFP and requested by BARDA

 

  1.2.3

Title: Reporting

Objective/Description of Work: Avita will comply with all reporting requirements as outlined and formatted in the RFP and as requested by BARDA. All Report information will be consolidated into the reports generated for CLIN 0001.

 

 

 

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  1.4

IMS and EVM

 

WBS# and Title

  

Milestone

  

Deliverable

1.4.2 Performance Measurement Baseline   

Performance

Measurement Baseline Review (PMBR)

   Performance Measurement Baseline Review Plan and Required Components – A plan detailing a schedule of deliverables, costs, milestones, and risks that will serve as the basis for measuring project progress.
1.4.3 Integrated Master Schedule    IMS Approved by BARDA    The IMS shall be provided at the work package level in MS Project file format, for the PMBR and monthly thereafter, in order to monitor performance of the contract.
1.4.4 Monthly Earned Value Performance Report    Delivery to and acceptance by BARDA    Monthly Earned Value Performance Report
1.4.5 Supplemental monthly CAP report    Delivery to and acceptance by BARDA    Supplemental monthly CAP report

 

  1.4.3

Title: Performance Measurement Baseline

Objective/Description of Work: The Performance Measurement Baseline will provide a master schedule of deliverables, costs, and milestones in order to completely cover all items in the SOW. All required components will be submitted to BARDA within 90 days of contract award. BARDA and Avita will mutually agree on the budget, schedule and technical plan baselines as a result of the PMBR.

 

  1.4.3

Title: Integrated Master Schedule (IMS)

Objective/Description of Work: The IMS will be used to monitor performance against the contract. Avita will develop an IMS in a format approved by BARDA in order to track key milestones, Go/No Go decision gates. The IMS will contain baseline start and finish, forecast start and finish, actual start and finish, predecessor and/or successor. Avita will provide a baseline IMS for the PMBR and monthly updates thereafter.

 

  1.4.4

Title: Monthly Earned Value Performance Report

Objective/Description of Work: The Monthly Earned Value Performance Report will be generated from Avita’s EVMS in order to track any project variances against the baseline. The report will contain technical, schedule, and cost status information in order to identify any issues that may impact project progress and/or cost.

 

  1.4.5

Title: Supplemental Monthly CAP Report

Objective/Description of Work: The Supplemental Monthly CAP Report will be generated from Avita’s EVMS and will contain cost information to report on the time phased budget, earned value, and actual costs of work performed. The report will be submitted monthly to BARDA for review.

 

 

 

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2

Non-Clinical Objectives

 

  2.1

Title Quality System Upgrades

 

WBS# and Title

  

Milestone

  

Deliverable

2.1.1 Quality System Upgrade    Completion of Quality Systems Audit by independent 3rd Party    Audit Report(s)

 

  2.1.1

Title Quality System Upgrades

Objective/Description of Work: Perform additional independent 3rd party mock FDA audits and mitigation activities at Parker Hannifin and/or Avita Medical as required. Augment current Avita staff to oversee initial production builds to assure supplier compliance that all manufacturing records are accurate and complete (Quality Engineer). Additionally, we have recognized the need for a Quality Assurance/Regulatory Affairs Specialist to provide timely assessment of reports of device failure complaints and CAPA’s, providing more accurate and relevant analysis, administration and reporting. This position will also facilitate quality and regulatory development and review of manufacturing and product changes, PMA supplements and Annual Reports.

 

  2.2

Title Update the Burn Care Pathway Model

Objective/Description of Work: Goals of the research: To add to the underlying calculations, data, interface and documentation of the existing Burn Care Pathway Model.

 

  2.2.1

Title Update the Burn Care Pathway Model with Pediatric Data

Objective/Description of Work: Although the existing Burn Care Model includes pediatric patients as well as indeterminate deep partial or superficial partial thickness burns, assumptions are currently in place regarding burn management and relevant inputs. In particular, accuracy of diagnosis impacts whether a partial thickness burn is treated like a full thickness burn, or whether the burn is assumed to heal without grafting. Additionally, although resource use for children reflects smaller body surface area, other costs are assumed equivalent between children and adults due to lack of pediatric-specific expert insight. As Avita is currently planning two clinical trials to support the use of ReCell in pediatric patients with partial thickness burns, additional detail can be added to the model following completion of these protocols. All optional tasks will require review and discussion between BARDA and Avita for need and scope, prior to submission of a COA request to proceed being initiated.

 

WBS# and Title

  

Milestone

  

Deliverable

2.2.1.1 Trial-based resource use and costs    Data inputs incorporated into the Burn Care Pathway Model.    A summary file in MS Excel and data inputs incorporated into the Burn Care Pathway Model.
2.2.1.2 Clinical Trial Evidence Review and Storyboard    Completion of Storyboard    Storyboard Presentation
2.2.1.3 KOL Validation    KOL input compete    KOL proposed changes to validate model inputs.

 

 

 

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2.2.1.4 Model Update/Expansion & Preliminary Results    Completion of Proposed changes to existing Burn Care Pathway Model    A brief set of slides (<10) documenting the pediatric partial thickness burn scenario methods and results.

2.2.1.5 Model

Finalization/Quality Control (QC) & Final Results

   QC is complete and the model is locked down    Preliminary results slides will be updated to reflect final results
2.2.1.6 Updated Technical Reporting    Completion of updated written technical report for the Burn Care Pathway Model    Updated written technical report for the Burn Care Pathway Model

2.2.1.7 Title: Optional

Additional

Communications Presentations

   Completion of Slide Presentation    Completed Slide Presentation
2.2.1.8 Title: Optional Abstract/Poster    Completion of Abstract/Poster    Completed Abstract/Poster
2.2.1.9 Title: Optional Manuscript    Completion of Manuscript    Completed Manuscript

 

  2.2.1.1

Title: Trial-based resource use and costs.

Objective/Description of Work: [**] (QI) will aid with the identification of trial-based resource use and costs through manual processing and review of hospital billing records. Avita will facilitate acquisition of the hospital billing records through the trial. These files would be provided in a HIPAA-compliant manner to QI project team members (for up to 200 patients based on power calculations from the partial thickness burn protocol). Data would be extracted according to a pre-approved process and template. A summary file in MS Excel would be provided for review upon completion, and data inputs incorporated into the Burn Care Pathway Model.

 

  2.2.1.2

Title: Clinical Trial Evidence Review and Storyboard

Objective/Description of Work:

 

   

Upon availability of the clinical trial evidence 01 will draft a brief set of slides detailing the specific fields that would be added to the model or updated using trial-based data;

 

   

QI would present this information for comment;

 

   

Upon receipt of consolidated feedback, QI will revise in a final storyboard prior to commencing with model changes.

 

 

 

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  2.2.1.3

Title: KOL validation

Objective/Description of Work: Targeted conversations with at least two pediatric burn surgeons regarding the proposed changes to validate model inputs.

 

  2.2.1.4

Title: Model Update/Expansion & Preliminary Results

Objective/Description of Work:

 

   

Following delivery of the final storyboard, QI will make proposed changes to the existing Burn Care Pathway Model, affecting both the underlying calculations and interface as relevant;

 

  2.2.1.5

Title: Model Finalization/Quality Control (QC) & Final Results

Objective/Description of Work:

 

   

Upon review of the preliminary model and results, minor clarifications or additional explorations will be addressed as QI moves forward to finalize the model and initiate the QC process;

 

   

QC would include a full review, including ensuring that the following general areas have been examined (documentation available upon request):

 

   

Clarity (screen orientation and design, assumptions, referencing, inputs, results)

 

   

Accuracy (review input parameters/Visual Basic code/named ranges, formula auditing)

 

   

Consistency (naming conventions, graphics, logos)

 

   

Testing and model functionality (pressure testing with extreme values, scenario investigations)

 

   

Once QC is complete and the model is locked down, the preliminary results slides will be updated to reflect final results, and these will be shared again with Avita.

 

  2.2.1.6

Title: Updated Technical Reporting

Objective/Description of Work: QI will also update the written technical report for the Burn Care Pathway Model, in order to ensure that documentation remains aligned with the model itself, thus facilitating continued use as new individuals may need to use the model.

 

  2.2.1.7

Title: Optional Additional Communications Presentations

Objective/Description of Work: QI help to develop content for presentation materials to facilitate targeted internal or external communication (a single presentation of no more than 30 slides).

 

  2.2.1.8

Title: Optional Abstract/Poster

 

 

 

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Objective/Description of Work: An abstract will be submitted to an appropriate industry conference meeting to be decided in consultation. This abstract will be written collaboratively. Once accepted, QI will develop the poster or presentation, in consultation, for presentation at the conference meeting.

 

  2.2.1.9

Title: Optional Manuscript

Objective/Description of Work: Manuscript. 01 will prepare a manuscript for publication that summarizes the study’s methods and findings for this model expansion. From a process standpoint, the draft manuscript will be submitted to Avita for review and comment, after which 01 will make one round of revisions. After approval, QI will submit the manuscript to a peer-reviewed journal mutually agreeable to [**] and BARDA/Avita. QI will conduct one round of narrative revisions requested by journal reviewers and will resubmit once, if necessary. Substantial revisions requested by journal reviewers, including revisions that require additional data analysis, or a mutual decision to resubmit the manuscript to a separate journal, may require a scope amendment for this task. 01 adheres to authorship guidelines as established by ICMJE (www.icmje.org/ethicalalauthor.html).

 

  2.2.2

Title Optional Tasks to Update the Burn Care Pathway Model with Outpatient Data

Objective/Description of Work: Optional work is proposed to add to or amend the underlying calculations, interface and documentation of the existing Burn Care Model, to support discussions regarding outpatient use of ReCell. All optional tasks will require review and discussion between BARDA and Avita for need and scope, prior to submission of a COA request to proceed being initiated.

 

  2.2.2.1

Title Option 1: Burn Care Model Expansion: Outpatients

Objective/Description of Work: One possible use for ReCell technology is in an outpatient setting, to alleviate the need for inpatient beds or time, which would be highly valuable to relieve the bottlenecks in the event of mass casualty. While the burn care model has been established to make use of trial data and inpatient resource use and costing assumptions, the outpatient setting differs significantly, with changes needed to accommodate:

 

   

Defining the types of burns that could be managed in an outpatient setting (including primary outpatient intervention as well as post-discharge outpatient follow-up care);

 

   

Resource use specific to these burn types and outpatient facilities;

 

   

Unit costs specific to outpatient resource use.

 

WBS# and Title

  

Milestone

  

Deliverable

2.2.2.1.1 Option 1 Task 1 Evidence Review and Storyboard    Completed Storyboard Shell    Completed Storyboard Shell
2.2.2.1.2 Option 1 Task 2 KOL Interviews and Management    KOL Interviews Completed    Results of KOL Interviews
2.2.2.1.3 Option 1 Task 3 Storyboard update    Presentation of Final Storyboard    Presentation of Final Storyboard

 

 

 

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WBS# and Title

  

Milestone

  

Deliverable

2.2.2.1.4 Option 1 Task 4 Model Update/Expansion & Preliminary Results    Completion of Preliminary Results    Presentation of Preliminary Results
2.2.2.1.5 Option 1Task 5 Model Finalization/Quality Control (QC) & Final Results    QC and Final Results complete    Presentation of Final Results

2.2.1.1.6 Option 1 Task 6

Full Technical Reporting

   Completion of Technical Report    Presentation of Final Technical Report
2.2.2.1.7 Option 1 Task 7 Manuscript    Completion of Manuscript of publishable quality that summarize study methods and findings for this outpatient scenario.    Manuscript of publishable quality that summarize study methods and findings for this outpatient scenario.
2.2.2.2 Option 2 Model Version 2.0 updates    Finalized Model    Updated Model
2.2.2.3 Option 3 Bank of Hours for Scope Amendments    TBD    TBD
2.2.2.4 Option 4 Abstract/Poster    Completed Abstract/Poster    Completed Abstract/Poster
2.2.2.5 Option 5 Additional Manuscripts    Completion of Manuscript    Completed Manuscript

 

  2.2.2.1.1

Title Option 1 Task 1 Evidence Review and Storyboard

Obiective/Description of Work:

 

   

Review the model and clinical literature to understand what burns may be managed as outpatient, and what that management would entail

 

   

Develop a storyboard shell with all available data

 

  2.2.2.1.2

Title Option 1 Task [**] KOL Interviews and Management

Objective/Description of Work:

 

   

This task would include at least 5-6 hours per KOL to ensure adequate feedback storyboard content and data gaps, and draft model content

 

  2.2.2.1.3

Title Option 1 Task 3 Storyboard update

 

 

 

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Objective/Description of Work:

 

   

The KOL discussion responses will be folded into a storyboard revision. This storyboard will be presented for consolidated feedback a second time.

 

   

Any comments will be addressed in a final version that will serve as the blueprint for amending the model.

 

  2.2.2.1.4

Title. Option 1 Task 4 Model Update/Expansion & Preliminary Results

Objective/Description of Work:

 

   

Make proposed changes to the existing Burn Care Model, affecting both the underlying calculations and interface.

 

   

Generate preliminary results for review with Avita. Append additional slides (<10) to the storyboard to summarize the preliminary results for the outpatient setting.

 

  2.2.2.1.5

Title. Option 1 Task 5 Model Finalization/Quality Control (QC) & Final Results

Obiective/Description of Work:

 

   

Update model based on Avita feedback on preliminary results.

 

   

QC, including a full review, to ensure that the following areas have been examined (documentation available upon request):

 

   

Clarity (screen orientation and design, assumptions, referencing, inputs, results)

 

   

Accuracy (review input parameters/Visual Basic code/named ranges, formula auditing)

 

   

Consistency (naming conventions, graphics, logos)

 

   

Testing and model functionality (pressure testing with extreme values, scenario investigations)

 

   

Lock down model and update storyboard slides to reflect final results

 

  2.2.1.1.6

Title Option 1 Task 6 Full Technical Reporting

Objective/Description of Work:

 

   

Create a technical report to detail the purpose, methods, and results for the outpatient setting.

 

   

Refine report based on feedback

 

  2.2.2.1.7

Title Option 1 Task 7 Manuscript

Objective/Description of Work:

 

   

Prepare manuscript of publishable quality that summarize study methods and findings

 

 

 

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  2.2.2.2

Title Option 2 Model Version 2.0 updates

Objective/Description of Work:

Update the existing original model (version 1.0) in a second iteration (version 2.0). This task would entail summarizing the changes that will be made via slides; these would be shared with Avita for review and comment, after which a final summary of the agreed-upon updates will be circulated. This final summary will serve as the blueprint for model updates; after these are made and preliminary results are shared, the model will undergo targeted quality control and finalized

 

  2.2.2.3

Title Option 3 Bank of Hours for Scope Amendments

Objective/Description of Work:

It has been observed that the details of data gaps and required effort to fill those may not be anticipated. Therefore, we propose that a bank of hours may permit us to pursue those data pieces or other adjustments to the scope on a time and materials basis.

 

  2.2.2.4

Title Option 4 Abstract/Poster

Objective/Description of Work:

Up to four Abstract/Poster sets given the addition of a new scenario for dissemination, as well as possible additional topics, it may be valuable to plan for a flexible publication strategy. Potential topics for consideration include:

 

   

Outpatient setting analysis

 

   

Pediatric setting analysis

 

   

Model Version 2.0 release with payer analyses

 

   

Any additional data analyses

 

  2.2.2.5

Title Option 5 Additional Manuscripts

Objective/Description of Work:

Up to three additional manuscripts Prepare additional manuscript(s) of publishable quality that summarize study methods and findings for a scenario or analysis of interest.

 

   

Draft manuscript(s) will be submitted for review and comment

 

   

Make one round of revisions.

 

   

Submit the manuscript to a peer-reviewed journal mutually agreeable.

 

   

Conduct one round of narrative revisions requested by journal reviewers and resubmit if necessary.

 

 

 

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  2.3

Title ReCell Commercialization and Sustainability Planning

 

WBS# and Title

  

Milestone

  

Deliverable

2.3.1 Commercialization and Sustainability

Planning

   Commercialization and Sustainability Strategy Readiness    Quarterly and/or Bi-Annual Briefing and Written Reports to BARDA communicating product commercialization strategy and Sustainability.

 

  2.3.1

Title Commercialization Planning

Obiective/Description of Work: BARDA will supplement resources to ensure sustainability through development of a robust commercialization plan including the following:

 

   

Market Analysis and Planning

 

   

In-depth characterization of current (burn) market opportunity (SWOT, PEST), including competitive analysis, lessons learned from pioneers and launch risks and mitigation steps

 

   

Plan for increasing market adoption and penetration

 

   

US

 

   

OUS (EU, Asia Pac, ROW)

 

   

In-depth US pricing evaluation plan

 

   

Identify revenue maximizing price and volumes based on price elasticity of demand projections

 

   

Promotional Plan Development (market strategy)/Strategic Product Plan

 

   

Value Proposition (features/benefits/claims)

 

   

Communication plan

 

   

Messaging plan

 

   

PR/Conference exhibit plan

 

   

Print assets plan

 

   

Strategic and Communication Plan Validation

 

   

SWOT (Strengths, Weaknesses, Opportunities, Threats) Analysis

 

   

PEST (Political, Economic, Social, Technological) Analysis

 

   

Payor/Access Planning (US reimbursement)/New Technology Add-On

 

   

Sustainability Planning

 

   

Supply Chain management

 

   

Manufacturing Scale Up

 

3

Clinical

 

  3.1

Pediatric Donor Site Study

 

WBS# and Title

  

Milestone

  

Deliverable

3.1.1 Clinical Protocol    Protocol developed    Final Protocol
3.1.2 Electronic Data Capture    Electronic Data Capture (EDC) on-line    Electronic Data Capture (EDC) on-line notification
3.1.3 First Site Ready for Enrollment    First Site Ready for Enrollment    First Site Ready for Enrollment

 

 

 

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WBS# and Title

  

Milestone

  

Deliverable

3.1.4 First Subject First Visit    First Subject First Visit (FSFV) Completed    First Subject First Visit
3.1.5 50% Primary Effectiveness Endpoint Visit    50% of Visits Complete    Sample Size Recommendation
3.1.6 Last Subject Last Visit    Last Subject Last Visit (LSLV) Complete    Last Subject Last Visit
3.1.7 Database Lock    Database Lock    Database Lock
3.1.8 Data Analysis    Data Analysis Report    Data Analysis Report
3.1.9 Draft CSR    Draft CSR Complete    Draft CSR Complete
3.1.10 Final CSR    Final CSR Completed    Final CSR review complete and data is determined to be sufficient for FDA submission, Tables Listings & Figures.

 

  3.1

Title: Pediatric Donor Site Study

Objective/Description of Work: This is a prospective, within-subject paired, randomized (1:1), blinded evaluator, multicenter trial to investigate whether application of autologous skin cell suspension prepared with the ReCell device (i.e., RES) can be safely and effectively used to promote wound healing of donor-sites created for sourcing tissue during treatment of skin defects which require autografting. Additionally, the impact of the use of RES will be investigated with respect to donor site scar outcomes and physician/subject treatment preference as pre-specified secondary endpoints. Safety will be evaluated in terms of donor-site morbidity including but not limited to infection, allergic reaction, delayed healing, pain and scar. A minimum of 50 subjects will be enrolled in this study and a maximum of 100. Additional staff to support Field Clinical Support, Recruitment and Medical Science Liaison activities have been proposed to ensure the study is adequately staffed. These positions will be pre-coordinated with BARDA prior to hiring.

The clinical study will be prepared and approved, including:

 

   

Protocol with inclusion and exclusion criteria and endpoints

 

   

IDE application written and submitted

 

   

FDA approval of the IDE

 

   

Local IRB approvals

 

   

Clinical study site agreements

 

   

Clinical study site initiation visits

 

   

Investigator Meetings

The study protocol and CSR reports will be submitted to BARDA for review and comment prior to submitting to FDA. Additionally, an independent medical monitor or a Clinical Events Committee (CEC) and Data Monitoring Committee (DMC) will be utilized.

 

  3.2

Pediatric Partial Thickness Study

 

 

 

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WBS# and Title

  

Milestone

  

Deliverable

3.2.1 Clinical Protocol    Protocol developed    Final Protocol
3.2.2 Electronic Data Capture    Electronic Data Capture (EDC) on-line    Electronic Data Capture (EDC) on-line notification
3.2.3 First Site Ready for Enrollment    First Site Ready for Enrollment    First Site Ready for Enrollment
3.2.4 First Subject First Visit    First Subject First Visit (FSFV) Completed    First Subject First Visit
3.2.5 50% Primary Effectiveness Endpoint    50% of Visits Complete    Interim Analysis Report, Tables Listings and Figures, and Sample Size Recommendation.
3.2.6 Last Subject Last Visit    Last Patient Last Visit (LSLV) Complete    Last Subject Last Visit
3.2.7 Database Lock    Database Lock    Database Lock
3.2.8 Data Analysis    Data Analysis Report    Data Analysis Report
3.2.9 Draft CSR    Draft CSR Complete    Draft CSR Complete
3.2.10 Final CSR    Final CSR Completed    Final CSR review complete and data is determined to be sufficient for FDA submission, Tables Listings & Figures.

 

  3.2

Title: Pediatric Partial-thickness Study

Objective/Description of Work: This is a 2-arm, randomized (1:1), multicenter trial to compare the clinical performance of RES prepared from the ReCell® device versus dressings alone in males and females aged 1-16 years with a partial-thickness burn injury involving 2 to 20% of their total body surface area (TBSA). It is hypothesized that application of RES will reduce the incidence of progression to surgical intervention with autografting. Additionally, this study will compare longer-term scar outcomes, and pain and distress experienced during dressing changes. It is anticipated that a minimum of 226 subjects and a maximum of 280 subjects will be enrolled in this study with approximately 113 subjects each randomized to receive application of RES or control dressings to the partial-thickness burn.

The clinical study will be prepared and approved, including:

 

   

Protocol with inclusion and exclusion criteria and endpoints

 

   

IDE application written and submitted

 

   

FDA approval of the IDE

 

   

Local IRB approvals

 

   

Clinical study site agreements

 

   

Clinical Study Site Initiation Visits

 

   

Investigator Meetings

 

 

 

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The study protocol and CSR reports will be submitted to BARDA for review and comment prior to submitting to FDA. Additionally, an independent monitor or a Clinical Events Committee (CEC) and Data Monitoring Committee (DMC) will be utilized.

 

4

Regulatory

 

4.1

Pediatric /Supplemental Regulatory activities

 

WBS# and Title

  

Milestone

  

Deliverable

4.1.1 Pediatric IDE    FDA approval of pediatric IDE    Pediatric IDE Submission, IDE re-submission, IDE approval, Final Report
4.1.2 Donor Site PMA supplement    FDA approval of expanded indication for Donor Sites    Submission for Donor Site label expansion
4.1.3 Pediatric Partial – thickness Injury PMA supplement    FDA approval of expanded indication or Pediatric Partial- thickness injuries    Submission for Pediatric Partial-thickness injury label expansion

4.1.4 Supplemental

Regulatory actions

   Activity requiring FDA supplemental materials, FDA PMA Panel if required.    Supplemental Regulatory actions as required i.e. FDA Meeting Minutes, Clinical Protocol Amendments, FDA pre-submission meeting, SAP, Follow-up Submissions. Avita will share both draft and final versions of any regulatory interactions.
4.1.5 Annual IDE Reports    Annual IDE Reports Submitted    Annual IDE Report Delivered to BARDA (draft and final reports)
4.1.5 Annual PMA Reports    Annual PMA Reports Submitted    Annual PMA Report Delivered to BARDA (draft and final reports)

 

4.1

Title: Pediatric Indication and Supplemental Regulatory Support

Objective/Description of Work: Avita will make the regulatory filings with FDA for a pediatric IDE clinical trial and PMA supplements for expansion of labeling for Donor Sites and Pediatric Partial-thickness injury indications. Support FDA PMA Panel Prep if required. Submit Annual IDE and PMA reports.

CLIN 0005 – Procurement (Surge)

 

 

 

Avita Medical Statement of Work, 09/18/2017

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7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received    Additional product to meet surge capacity (Less than 2,000 Units)

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

CLIN 0006 – Procurement (Surge)

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received’    Additional product to meet surge capacity ([**] Units)

 

  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

CLIN 0007 – Procurement (Surge)

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received    Additional product to meet surge capacity ([**])

 

 

 

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  7.1.1.2

Title: Product Manufacturing

Objective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

CLIN 0008 – Procurement (Surge)

 

7

Procurement

 

  7.1

Acquisition

 

WBS# and Title

  

Milestone

  

Deliverable

7.1.2.2 Product Manufacturing    Order Received    Additional product to meet surge capacity ([**] Units)

 

  7.1.1.2

Title: Product Manufacturing

Obiective/Description of Work: BARDA would authorize the surge procurement order to acquire additional ReCell devices beyond the initial order. Upon receiving the order Avita would authorize the manufacturer to begin acquiring supplies for the manufacture of the additional devices.

Milestones:

 

  7.1.2.1

Order Received

Deliverables:

 

  7.1.2.2

Surge Capacity Product – Upon receiving the procurement order from BARDA, Avita will manufacture ReCell devices according to the additional products required to meet surge capacity. Product will be deployed to designated VMI locations.

 

 

 

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EX-4.7

Exhibit 4.7

 

LOGO

Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. Double asterisks denote omissions. AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES 1 3 2. AMENDMENT/MODIFICATION NO. 0004 3. EFFECTIVE DATE See Block 16C 4. REQUISITION/PURCHASE REQ. NO. OS222377 5. PROJECT NO. (If applicable) 6. ISSUED BY CODE ASPR—BARDA 7. ADMINISTERED BY (If other then item 6) CODE ASPR—BARDA ASPR-BARDA 200 Independence Ave., S.W. Room 640-G Washington DC 20201 ASPR-BARDA 200 Independence Ave., S.W. Room 638-G Washington DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street. county. State and ZIP Code) (x) 9A. AMENDMENT OF SOLICITATION NO. AVITA MEDICAL AMERICAS, LLC 1476585 AVITA MEDICAL AMERICAS, LLC 92 28159 Avenue Stanford Suite 220 Valencia CA 91355 9B. DATED (SEE ITEM 11) X 10A. MODIFICATION OF CONTRACT/ORDER NO. HHS0100201500028C 10B. DATED (SEE ITEM 13) 09/29/2015 CODE 1476585 FACILITY CODE 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS â–¡ The above numbered solicitation is amended as set forth in Item 14. The hour and dale specified for receipt of Offers â–¡ is extended.    â–¡ is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified M the solicitation or as amended by one of the following methods: (a) By completing Items B and 15, and returning copies of the amendment (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate teller or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER If try virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and Is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) 2018.199TWNP.25103 Net Increase [**] 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE iN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation dale, etc.) SET FORTH IN ITEM 14. PURSUANT TO THE AUTHORITY OF FAR43.103(b). x C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: FAR 52.243-2 Changes — Cost Reimbursement D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor â–¡ is not. â–¡ is required to sign this document and return 2 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) Tax ID Number: 20-2578762 DUNS Number: 026723570 To modify ARTICLE B.3 OPTION PRICES. Funds Obligated Prior to this Modification: [**] Funds Obligated with mod #04: [**] Total Funds Obligated to Date: $50,414,137 PSC Code: 6505 Continued … Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged arid in lull farce and affect. 15A. NAME AND TITLE OF SIGNER (Type or print) Timothy Rooney CAO 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Christopher Scott 15B. CONTRACTOR/OFFEROR /s/ Timothy Rooney (Signature of person authorized to sign) 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA /s/ Christopher Scott (Signature of Contracting Officer) 16C. DATE SIGNED 7/2/18

 

1


CONTINUATION SHEET   

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHS0100201500028C/0009

   PAGE OF
   2    3

 

NAME OF OFFEROR OR CONTRACTOR

AVITA MEDICAL AMERICAS, LLC 1476585

 

ITEM NO.

(A)

  

SUPPLIES/SERVICES

(B)

   QUANTITY
(C)
     UNIT
(D)
     UNIT PRICE
(Li
     AMOUNT
(F)
 
  

Expiration date: [**], 2022 (Unchanged)

 

Delivery: 07/02/2018

Delivery Location Code: HHS/OS/ASPR

HHS/OS/ASPR

200 C St SW

WASHINGTON DC 20201 US

 

Appr. Yr.: 2018 CAN: 199TWNP Object Class: 25103

FOB: Destination

Period of Performance: [**]/2015 to [**]/2022

 

Add Item 10 as follows:

           

10

  

ASPR-18-03004 — Avita’s indirect cost rate true up for FY2016 and FY2017 ending [**]/17 – HHS0100201500028C

Obligated Amount: [**]

              [**]  

 

2


ARTICLE B.3. OPTION PRICES are hereby modified as follows

 

CLIN

  

Period of

Performance

  

Supplies! Services

  

Units (# of
Product)

  

Unit Price
($)

  

Total ($)

FIRM FIXED PRICE

0003

(Option)

   [**] Months    Phase IV post marketing commitments /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as established by the FDA)    N/A    N/A    [**]
0009   

[**]/15 —

[**]/22

   FY 2016/FY2017 Final Rate True Up    N/A    N/A    [**]
COST REIMBURSEMENT   

0004

(Option)

  

[**]/17 —

[**]/22

   Pediatric Study (This is an option that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)    [**]    [**]    [**]
FIRM FIXED PRICE

0005

(Option)

   36 Months    Additional Surge Capacity    [**]    [**]    [**]

0006

(Option)

   36 Months    Additional Surge Capacity    [**]    [**]    [**]

0007

(Option)

   36 Months    Additional Surge Capacity    [**]    [**]    [**]
  

 

36 Months

  

 

Additional Surge Capacity

  

 

[**]

  

 

[**]

 

0008

(Option)

  

 

[**]

Total Unfunded Option CLINs 3, 5-8    60 Months    See Above Descriptions          [**]

 

*

CLIN 0009 is exercised with this modification

All other terms and conditions of this contract remain unchanged.

End of Modification #3

 

3

EX-4.8

Exhibit 4.8

STANDARD INDUSTRIAL/COMMERCIAL MULTI-TENANT LEASE—GROSS

AMERICAN INDUSTRIAL REAL ESTATE ASSOCIATION

 

1.

Basic Provisions (“Basic Provisions”).

1.1     Parties: This Lease (“Lease”), dated for reference purposes only, January 25, 2018    is made by and between Hartco Ventura Inc.                                                                     (“Lessor”)              and            Avita Medical Americas, LLC, A Delaware limited liability company                                                             (“Lessee”), (collectively the “Parties,” or individually a Party”).

1.2(a) Premises: That certain portion of the Building, including all improvements therein or to be provided by Lessor under the terms of this Lease, commonly known by the street address of 3007 Bunsen Avenue, Units I, J, K, L, M, N, located in the City of      Ventura                , County of         Ventura                , state of California with zip code     93003    , as

outlined on Exhibit    A                attached hereto (“Premises”). The “Building” is that certain building containing the Premises and generally described as (describe briefly the nature of the

Building): An approximately 23,040 square feet (units, I, J, K, L, M, N), Part of a larger 88,080 square feet multi-tenant industrial complex located on approximately 192,500 square feet of MPD zoned land.

In addition to Lessee’s rights to use and occupy the Premises as hereinafter specified, Lessee shall have non-exclusive rights to the Common Areas (as defined in Paragraph 2.7 below) as hereinafter specified, but shall not have any rights to the roof, exterior walls or utility raceways of the Building or to any other buildings in the Industrial Center. The Premises, the Building, the Common Areas, the land upon which they are located, along with all other buildings and improvements thereon, are herein collectively ref to as the “industrial Center.” (Also see Paragraph 2.)

1.2(b) Parking:_Twenty four (24) unreserved vehicle parking spaces (“Unreserved Parking Spaces”); and    Twelve (12)                      reserved vehicle parking spaces (“Reserved Parking Spaces”). (Also see Paragraph 2.6.)

1.3     Term:        3        years and        0    months (“Original Term”) commencing    October, 1,

          ,2018                                                                                                           

(“Commencement Date”) and ending    September 30, 2021                                                     (Expiration Date”). (Also see Paragraph 3.)

1.4     Early Possession:             See Paragraph 49                                                                 (“Early Possession Date”). (Also see Paragraphs 3.2 and 3.3.)

1.5     Base Rent: _$24,192.00         per month (“Base Rent’) payable on the        First            day of each month commencing October 1, 2018. [ X ] If this box is checked, this Lease provides for the Base Rent to be adjusted per Addendum    51        , attached hereto.

1.6(a) Base Rent Paid Upon Execution:                                           as Base Rent for the period                                                                                 ,

1.6(b) Lessee’s Share of Common Area Operating Expenses:                     Zero                             percent (        %) (“Lessee’s Share”) as determined by                                                                                                                                                    

[  ] prorata square footage of the Premises as compared to the total square footage of the Building or[  ] other criteria as described in Addendum

1.7     Security Deposit:                 $24,192.00                             (“Security Deposit”). (Also see Paragraph 5.)

1.8     Permitted use Manufacturing of medical products, which will entail the use of certain substances which may be subject to paragraph 6.2 below (including without limitation Isopropyl alcohol, solder, and alkaline batteries)

                                                                                                                                                                    (“Permitted Use”) (Also see Paragraph 6.)

1.9     Insuring Party. Lessor is the Insuring Party.” (Also see Paragraph 8.)

1.10(a)        Real Estate Brokers. The following real estate brokers) (collectively, the Brokers) and brokerage relationships exist in this transaction and are

consented to by the Parties (check applicable boxes):

[  ]                    N/A                                         represents Lessor exclusively (“Lessor’s Broker”);

[  ]                N/A                                                                      represents Lessee exclusively (“Lessee’s Broker”); or

[  ]                    N/A                                                                  represents both Lessor and Lessee (“Dual Agency”). (Also see Paragraph 15.)

1.10(b)        Payment to Brokers. Upon the execution of this Lease by both Parties, Lessor shall pay to said Brokers) jointly, or in such separate shares as they may mutually designate in writing, a fee as set forth in a separate written agreement between Lessor and said Brokers) (or in the event there is no separate written agreement between Lessor and said Broker(s), the sum of $      N/A             J for brokerage services rendered by said Brokers) in connection with this transaction.

1.11 Guarantor. The obligations of the Lessee under this Lease are to be guaranteed

by                                                                                                                                                    

                                                                                                                                                                                                                     (“

Guarantor”). (Also see Paragraph 37.)

 

© American Industrial Real Estate Association 1993

MULTI-TENANT - GROSS

1


1.12 Addenda and Exhibits. Attached hereto is an Addendum or Addenda consisting of Paragraphs

                                              through                         , and Exhibits

                                  through                                         , all of which constitute a part of-this Lease.

2. Premises, Parking and Common Areas.

2.1 Letting. Lessor hereby leases to Lessee, and Lessee hereby leases from Lessor, the Premises, for the term, at the rental, and upon all of the terms, covenants and conditions set forth in this Lease. Unless otherwise provided herein, any statement of square footage set forth in this Lease, or that may have been used in calculating rental and/or Common Area Operating Expenses, is an approximation which Lessor and Lessee agree is reasonable and the rental and Lessee’s Share (as defined in Paragraph 1.6(b)) based thereon is not subject to revision whether or not the actual square footage is more or less.

2.2 Condition. Lessor shall deliver the Premises to Lessee clean and free of debris on the Commencement Date and warrants to Lessee that the existing plumbing, electrical systems fire sprinkler system, lighting, air conditioning and heating systems and loading doors, if any, in the Premises, other than those constructed by Lessee, shall be in good operating condition on the Commencement Date. If a non-compliance with said warranty exists as of the Commencement Date, Lessor shall, except as otherwise provided in this Lease, promptly after receipt of written notice from Lessee setting forth with specificity the nature and extent of such non-compliance, rectify same at Lessor’s expense. If Lessee does not give Lessor written notice of a non-compliance with this warranty within thirty (60) days after the Commencement Date, correction of that non-compliance shall be the obligation of Lessee at Lessee’s sole cost and expense.

2.3 Compliance with Covenants, Restrictions and Building Code. Lessor warrants that any improvements (other than those constructed by Lessee or at Lessee’s direction) on or in the Premises which have been constructed or installed by Lessor or with Lessor’s consent or at Lessor’s direction shall comply with all applicable covenants or restrictions of record and applicable building codes, regulations and ordinances in effect on the Commencement Date. Lessor further warrants to Lessee that Lessor has no knowledge of any claim having been made by any governmental agency that a violation or violations of applicable building codes, regulations, or ordinances exist with regard to the Premises as of the Commencement Date. Said warranties shall not apply to any Alterations or Utility Installations (defined in Paragraph 7.3(a)) made or to be made by Lessee. If the Premises do not comply with said warranties, Lessor shall, except as otherwise provided in this Lease, promptly after receipt of written notice from Lessee given within six (6) months following the Commencement Date and setting forth with specificity the nature and extent of such non-compliance, take such action, at Lessor’s expense, as may be reasonable or appropriate to rectify the non-compliance.

2.4 Acceptance of Premises. Lessee’s acceptance of the Premises is based upon Lessor’s warranty and representations: (a) that the Premises (including but not limited to the electrical and fire sprinkler systems, security, environmental aspects, seismic and earthquake requirements, and compliance with the Americans with Disabilities Act and applicable zoning, municipal, county, state and federal laws, ordinances and regulations and any covenants or restrictions of record (collectively, “Applicable Laws”)) are suitable for Lessee’s intended use; and (b) that neither Lessor, nor any of Lessor’s agents, has made any oral or written representations or warranties with respect to said matters other than as set forth in this Lease.

2.5 Lessee as Prior Owner/Occupant. The warranties made by Lessor in this Paragraph 2 shall be of no force or effect if immediately prior to the date set forth in Paragraph 1.1 Lessee was the owner or occupant of the Premises. In such event, Lessee shall, at Lessee’s sole cost and expense, correct any non-compliance of the Premises with said warranties.

2.6 Vehicle Parking. Lessee shall be entitled to use the number of Unreserved Parking Spaces and Reserved Parking Spaces specified In Paragraph 1.2(b) on those portions of the Common Areas designated from time to time by Lessor for parking. Lessee shall not use more parking spaces than said number. Said parking spaces shall be used for parking by vehicles no larger than full-size passenger automobiles or pick-up trucks, herein called “Permitted Size Vehicles.” Vehicles other than Permitted Size Vehicles shall be parked and loaded or unloaded as directed by Lessor In the Rules and Regulations (as defined in Paragraph 40) issued by Lessor. (Also see Paragraph 2.9.)

(a) Lessee shall not permit or allow any vehicles that belong to or are controlled by Lessee or Lessee’s employees, suppliers, shippers, customers, contractors or invitees to be loaded, unloaded, or parked in areas other than those designated by Lessor for such activities. Lessee’s employees, suppliers, shippers, customers contractors and invitees shall be permitted to access and use the loading facilities at the rear of the building, where the roll-up delivery doors are located, for pickup and delivery.

(b) If Lessee permits or allows any of the prohibited activities described In this Paragraph 2.6 then Lessor shall have the right, without notice, in addition to such other rights and remedies that it may have, to remove or tow away the vehicle Involved and charge the cost to Lessee, which cost shall be Immediately payable upon demand by Lessor.

(c) Lessor shall at the Commencement Date of this Lease, provide the parking facilities required by Applicable Law.

2.7 Common Areas-Definition. The term “Common Areas” Is defined as all areas and facilities outside the Premises and within the exterior boundary line of the Industrial Center and interior utility raceways within the Premises that are provided and designated by the Lessor from lime to time for the general nonexclusive use of Lessor, Lessee and other lessees of the Industrial Center and their respective employees, suppliers, shippers, customers, contractors and Invitees, Including parking areas, loading and unloading areas, trash areas, roadways, sidewalks, walkways, parkways, driveways and landscaped areas.

2.6 Common Areas-Lessee’s Rights. Lessor hereby grants to Lessee, for the benefit of Lessee and Its employees, suppliers, shippers, contractors, customers and invitees, during the term of this I-ease, the non-exclusive right to use, in common with others entitled to such use, the Common Areas as they exist from time to time, subject to any rights, powers, and privileges reserved by Lessor under the terms hereof or under the terms of any rules and regulations or restrictions governing the use of the Industrial Center. Under no circumstances shall the right herein granted to use the Common Areas be deemed to include the right to store any property, temporarily or permanently, In the Common Areas. Any such storage shall be permitted only by the prior written consent of Lessor or Lessor’s designated agent which consent may be revoked at any lime. In the event that any unauthorized storage shall occur then Lessor shall have the right, without notice, In addition to such other rights and remedies that it may have, to remove the property and charge the cost to Lessee, which cost shall be Immediately payable upon demand by Lessor.

2.9 Common Areas-Rules and Regulations. Lessor or such other person(s) as Lessor may appoint shall have the exclusive control and management of the Common Areas and shall have the right, from time to time, to establish, modify, amend and enforce reasonable Rules and Regulations with respect thereto In accordance with Paragraph 40. Lessee agrees to abide by and conform to ail such Rules and Regulations, and to cause its employees, suppliers, shippers, customers, contractors and Invitees to so abide and conform. Lessor shall not be responsible to Lessee for the non-compliance with said rules and regulations by other lessees of the Industrial Center.

 

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2.10 Common Areas-Changes. Lessor shall have the right, In Lessor’s sole discretion, from time to time:

(a) To make changes to the Common Areas, Including, without limitation, changes in the location, size, shape and number of driveways, entrances, parking spaces, parking areas, loading and unloading areas, Ingress, egress, direction of traffic, landscaped areas, walkways and utility raceways;

(b) To close temporarily any of the Common Areas for maintenance purposes so long as reasonable access to the Premises remains available;

(c) To designate other land outside the boundaries of the Industrial Center to be a part of the Common Areas;

(d) To add additional buildings and Improvements to the Common Areas;

(e) To use the Common Areas while engaged In making additional Improvements, repairs or alterations to the Industrial Center, or any portion thereof;

and

(f) To do and perform such other acts and make such other changes (n, to or with respect to the Common Areas and Industrial Center as Lessor may, In the exercise of sound business judgment, deem to be appropriate.

3. Term.

3.1 Term. The Commencement Date, Expiration Date and Original Term of this Lease are as specified in Paragraph 1.3.

3.2 Early Possession. If an Early Possession Date is specified in Paragraph 1.4 and If Lessee totally or partially occupies the Premises after the Early Possession Date but prior to the Commencement Date, the obligation to pay Base Rent shall be abated for the period of such early occupancy. All other terms of this Lease, however, (including but not limited to the obligations to pay Lessee’s Share of Common Area Operating Expenses and to carry the Insurance required by Paragraph 8) shall be in effect during such period. Any such early possession shall not affect nor advance the Expiration Date of the Original Term.

3.3 Delay in Possession. II for any reason Lessor cannot deliver possession of the Premises to Lessee by the Early Possession Dale, II one is specified in Paragraph 1.4, or If no Early Possession Date is specified, by the Commencement Date, Lessor shall not be subject to any liability therefor, nor shall such failure affect the validity of this Lease, or the obligations of Lessee hereunder, or extend the term hereof, but in such case, Lessee shall not, except as otherwise provided herein, be obligated to pay rent or perform any other obligation of Lessee under the terms of this Lease until Lessor delivers possession of the Premises to Lessee. II possession of the Premises is not delivered to Lessee within sixty (60) days after the Commencement Dale, Lessee may, at its option, by notice in writing to Lessor within ten (10) days after the end of said sixty (60) day period, cancel this Lease, in which event the parties shall be discharged from all obligations hereunder; provided further, however That it such written notice of Lessee is not received by Lessor within said ten (10) day period, Lessee’s right to cancel this Lease hereunder shall terminate and be of no further force or effect. Except as may be otherwise provided, and regardless of when the Original Term actually commences, if possession is not tendered to Lessee when required by this Lease and Lessee does not terminate this Lease, as aforesaid, the period free of the obligation to pay Base Rent, if any, that Lessee would otherwise have enjoyed shall run from the date of delivery of possession and continue for a period equal to the period during which the Lessee would have otherwise enjoyed under the terms hereof, but minus any days of delay caused by the acts, changes or omissions of Lessee.

4. Rent.

4.1 Base Rent. Lessee shall pay Base Rent and other tent or charges, as the same may be adjusted from time to time, to Lessor in lawful money of the United States, without offset or deduction, on or before the day on which it is due under the terms of this Lease. Base Rent and all other rent and charges for any period during he term hereof which is for less than one full month shall be prorated bused upon the actual number of days of the month involved: Payment of Base Rent and other charges shall be made to Lessor at its address stated herein or to such other persons or al such other addresses as Lessor may from time to lime designate (n writing to Lessee.

4.2 Common Area Operating Expenses. Lessee shall pay to Lessor during ‘the term hereof, In addition to the Base Rent, Lessee’s Share (as specified in Paragraph 1.6(b)) of all Common Area Operating Expenses, as hereinafter defined, during each calendar year of the term of this Lease, In accordance with the following provisions:

(a) “Common Area Operating Expenses” are defined, for purposes of this Lease, as all costs incurred by Lessor relating to the ownership and operation of the Industrial Center, Including, but not limited to, the following:

(i) The operation, repair and maintenance, In neat, clean, good order and condition, of the following:

(aa) The Common Areas, including parking areas, loading and unloading areas, trash areas, roadways, sidewalks, walkways, parkways, driveways, landscaped areas, striping, bumpers, irrigation systems, Common Area lighting facilities, fences and gates, elevators and roof.

(bb) Exterior signs and any tenant directories.

(cc) Fire detection and sprinkler systems.

(ii) The cost of water, gas, electricity and telephone to service the Common Areas.

(iii) Trash disposal, property management and security services and tile costs of any environmental Inspections.

(iv) Reserves set aside for maintenance and repair of Common Areas.

(v) Any Increase above the Base Real Property Taxes (as defined in Paragraph 10.2(b)) for the Building and the Common Areas.

(vi) Any “Insurance Cost Increase” (as defined In Paragraph 8.1).

(vii) The cost of insurance carried by Lessor with respect to the Common Areas.

(viii) Any deductible portion of an insured loss concerning the Building or the Common Areas.

(ix) Any other services to be provided by Lessor that are staled elsewhere in this Lease to be a Common Area Operating Expense.

 

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(b) Any Common Area Operating Expenses and Real Property Taxes that are specifically attributable to the Building or to any other building in the industrial Center or to the operation. repair and maintenance thereof shall be allocated entirely in the Building or in such other building. However any Common Area Operating Expenses and Real Property Taxes that are not attributable to the Building or to any other building or to the operation, repair and maintenance thereof, shall be equitably allocated by Lessor to all buildings in the Industrial Center.

(c) The inclusion of the improvements, facilities and services set forth in Subparagraph 4.2(a) shall not be deemed to impose an obligation upon Lessor to either have said improvements or facilities or to provide those services unless the Industrial Center already has the same, Lessor already provides the services, or Lessor has agreed elsewhere in this Lease to provide the same or some of them.

(d) Lessee’s Share of Common Area Operating Expenses shall be payable by Lessee within ten(10) days after a reasonably detailed statement of actual expenses is presented to Lessor, At Lessor’s option, however, an amount may be estimated by Lessor from time to time of Lessee’s Share of annual Common Area Operating Expenses and the same shall be payable monthly or quarterly, as Lessor shall designate, during each 12-month period of the Lease term, on the same day as the Base Rent is due hereunder. Lessor shall deliver to Lessee within sixty (60) days after the expiration of each calendar year a reasonably detailed statement showing Lessee’s Share of the actual Common Area Operating Expenses incurred during the preceding year. If Lessee’s payments under this Paragraph 4.2(d) during said preceding year exceed Lessee’s Share as indicated on said statement, Lessor shall be credited the amount of such overpayment against Lessee’s Share of Common Area Operating Expenses next becoming due. If Lessee’s payments under this Paragraph 4.2(d) during said preceding year were less than Lessee’s Share as Indicated on said statement, Lessee shat; pay to Lessor the amount of the deficiency within ten (10) days after delivery by Lessor to Lessee of said statement.

5. Security Deposit. Lessee shall deposit with Lessor upon Lessee’s execution hereof the Security Deposit set forth In Paragraph 1.7 as security for Lessee’s faithful performance of Lessee’s obligations under this Lease. If Lessee fails to pay Base Rent or other rent or charges due hereunder, or otherwise Defaults under this Lease (as defined in Paragraph 13.1), Lessor may use, apply or retain all or any portion of said Security Deposit for the payment of any amount due Lessor or to reimburse or compensate Lessor for any liability, cost, expense, loss or damage (Including attorneys’ fees) which Lessor may suffer or Incur by reason thereof. If Lessor uses or applies all or any portion of said Security Deposit, Lessee shall within ten (10) days after written request therefore deposit monies with Lessor sufficient to restore said Security Deposit to the full amount required by this Lease. Any time the Base Rent Increases during the term of this Lease, Lessee shall, upon written request from Lessor, deposit additional monies with Lessor as an addition to the Security Deposit so that the total amount of the Security Deposit shall at all times bear the same proportion to the then current Base Rent as the Initial Security Deposit bears to the initial Base Rent set forth in Paragraph 1.5. Lessor shall not be required to keep all or any part of the Security Deposit separate from Its general accounts. Lessor shall, at the expiration or earlier termination of the term hereof and after Lessee has vacated the Premises, return to Lessee (or, at Lessor’s option, to the last assignee, if any, of Lessee’s Interest herein), that portion of the Security Deposit not used or applied by Lessor. Unless otherwise expressly agreed In writing by Lessor, no part of the Security Deposit shall be considered to be held in trust, to bear Interest or other increment for its use, or to be prepayment for any monies to be paid by Lessee under this Lease.

6. Use.

6.1 Permitted Use.

(a) Lessee shall use and occupy the Premises only for the Permitted Use ;;et forth In Paragraph 1.8, or any other legal use which Is reasonably comparable thereto, and for no other purpose. Lessee shall not use or permit the use of the Premises In a manner that Is unlawful, creates waste or a nuisance, or that disturbs owners and/or occupants of, or causes damage to the Premises or neighboring premises or properties.

(b) Lessor hereby agrees to not unreasonably withhold or delay Its consent to any written request by Lessee, Lessee’s assignees or subtenants and by prospective assignees-and subtenants of Lessee, Its assignees and subtenants, for a modification of said Permitted Use, so long as the same will not impair the structural integrity of the Improvements on the Premises or in the Building or the mechanical or electrical systems therein, does not conflict with uses by other lessees, Is not significantly more burdensome to the Premises or the Building and the improvements thereon, and Is otherwise permissible pursuant to this Paragraph 6. If Lessor elects to withhold such consent, Lessor shall within five (5) business days after such request give a written notification of same, which notice shall include an explanation of Lessor’s reasonable objections to the change in use.

6.2 Hazardous Substances.

(a) Reportable Uses Require Consent. The term “Hazardous Substance” as used In this Lease shall mean any product, substance, chemical, material or waste whose presence, nature, quantity and/or Intensity of existence, use, manufacture, disposal, transportation, spill, release or effect, either by Itself or in combination with other materials expected to be on the Premises, Is either: (I) potentially Injurious to the public health, safety or welfare, the environment, or the Premises; (it) regulated or monitored by any governmental authority; or (iii) a basis for potential liability of Lessor to any governmental agency or third party under any applicable statute or common law theory. Hazardous Substance shall include, but not be limited to, hydrocarbons, petroleum, gasoline, crude oil or any products or by-products thereof. Lessee shall not engage in any activity in or about the Premises which constitutes a Reportable Use (as hereinafter defined) of Hazardous Substances without the express prior written consent of Lessor and compliance in a timely manner (at Lessee’s sole cost and expense) with all Applicable Requirements (as defined in Paragraph 6.3). “Reportable Use” shall mean (i) the Installation or use of any above or below ground storage tank, (ii) the generation, possession, storage, use, transportation, or disposal of a Hazardous Substance that requires a permit from, or with respect to which a report, notice, registration or business plan is required to be filed with, any governmental authority, and (iii) the presence in, on or about the Premises of a Hazardous Substance with respect to which any Applicable Laws require that a notice be given to persons entering or occupying the Premises or neighboring properties. Notwithstanding the foregoing, Lessee may, without Lessor’s prior consent, but upon notice to Lesser and In compliance with all Applicable Requirements, use any ordinary and customary materials reasonably required to be used by Lessee In the normal course of the Permitted Use, so long as such use is not a Reportable Use and does not expose the Premises or neighboring properties to any meaningful risk of contamination or damage or expose Lessor to any liability therefore. In addition, Lessor may (but without any obligation to do so) condition Its consent to any Reportable Use of any Hazardous Substance by Lessee upon Lessee’s giving Lessor such additional assurances as Lessor, in its reasonable discretion, deems necessary to protect Itself, the public, the Premises and the environment against damage, contamination or Injury and/or liability therefore, including but not limited to the Installation (and, at Lessor’s option, removal on or before Lease expiration or earlier termination) of reasonably necessary protective modifications to the Premises (such as concrete encasements) and/or the deposit of an additional Security Deposit under Paragraph 5 hereof.

(b) Duty to Inform Lessor. If Lessee knows, or has reasonable cause to believe, that a Hazardous Substance has come to be located in, on, under or about the Premises or the Building, other than as previously consented to by Lessor, Lessee shall Immediately give Lessor written notice thereof, together with a copy of any statement, report, notice, registration, application, permit, business plan, license, claim, action, or proceeding given to, or received from, any governmental authority or private party concerning the presence, spill, release, discharge of, or exposure to, such Hazardous Substance including but not limited to all such documents as may be involved in any Reportable Use involving the Premises, Lessee shall not cause or permit any Hazardous Substance to be spilled or released in, on, under or about the Premises (including, without limitation, through the plumbing or sanitary sewer system).

(c) Indemnification. Lessee shall indemnify, protect, defend and hold Lessor, its agents, employees, lenders and ground Lessor, if any, and the Premises; harmless from and against any and all damages, liabilities, judgments, costs, claims, Liens, expenses, penalties, loss of permits and attorneys’ and consultants’ lees arising out of or involving any Hazardous Substance brought onto the Premises by or for Lessee or by anyone-under Lessee’s control. Lessee’s obligations under this Paragraph 6.2(c) shall include, but not be limited to, the effects of any contamination or Injury to person, property or the environment created or suffered by Lessee, and the cost of investigation (including consultants’ and attorneys’ fees and testing), removal, remediation, restoration and/or abatement thereof, or of any contamination therein involved, and shall survive the expiration or earlier termination of this Lease. No termination, cancellation or release agreement entered Into by Lessor and Lessee shall release Lessee from its obligations under this Lease with respect to Hazardous Substances, unless specifically so agreed by Lessor In writing al the time of such agreement.

 

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6.3 Lessee’s Compliance with Requirements. Lessee shall, at Lessee’s sole cost and expense, fully, diligently and in a timely manner, comply with all “Applicable Requirements,” which term is used in this Lease to mean ail laws, rule;;, regulations, ordinances, directives, covenants, easements and restrictions of record, permits, the requirements of any applicable fire Insurance underwriter or rating bureau, and the recommendations of Lessor’s engineers and/or consultants, relating in any manner to the Premises (including but not limited to matters pertaining to (f) Industrial hygiene, (if) environmental conditions on, in, under or about the Premises, Including soil and groundwater conditions, and (iii) the use, generation, manufacture, production, installation, maintenance, removal, transportation, storage, spill, or release of any Hazardous Substance), now In effect or which may hereafter come into effect. Lessee shall, within live (5) days after receipt of Lessor’s written request, provide Lessor with copies of all documents and Information, Including but not limited to permits, registrations, manifests, applications, reports and certificates, evidencing Lessee’s compliance with any Applicable Requirements specified by Lessor, and shall immediately upon receipt, notify Lessor in writing (with copies of any documents involved) of any threatened or actual claim, notice, citation, warning, complaint or report pertaining to or involving failure by Lessee or the Premises to comply with any Applicable Requirements.

6.4 Inspection; Compliance with Law. Lessor, Lessor’s agents, employees, contractors and designated representatives, and the holders of any mortgages, deeds of trust or ground leases on the Premises (“Lenders”) shall have the right to enter the Premises at any time in the case of an emergency, and otherwise at reasonable times, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease and all Applicable Requirements (as defined in Paragraph 6.3), and Lessor shall be entitled to employ experts and/or consultants in connection therewith to advise Lessor with respect to Lessee’s activities, including but not limited to Lessee’s installation, operation, use, monitoring, maintenance, or removal of any Hazardous Substance on or from the Premises. The costs and expenses of any such inspections shall be paid by the party requesting same, unless a Default or Breach of this Lease by Lessee or a violation of Applicable Requirements or a contamination, caused or materially contributed to by Lessee, is found to exist or to be imminent, or unless the inspection is requested or ordered by a governmental authority as the result of any such existing or Imminent violation or contamination. In such case, Lessee shall upon request reimburse Lessor or Lessor’s Lender, as the case may be, for the costs and expenses of such inspections.

7. Maintenance, Repairs, Utility Installations, Trade Fixtures and Alterations.

7.1 Lessee’s Obligations.

(a) Subject to the provisions of Paragraphs 2.2 (Condition), 2.3 (Compliance with Covenants, Restrictions and Building Code), 7.2 (Lessor’s Obligations), 9 (Damage or Destruction), and 14 (Condemnation), Lessee shall, at Lessee’s sole cost and expense and at all times, keep the Premises and every part thereof in good order, condition and repair (whether or not such portion of the Premises requiring repair, or the means of repairing the same, are reasonably or readily accessible to Lessee, and whether or not the need for such repairs occurs as a result of Lessee’s use, any prior use, the elements or the age of such portion of the Premises), including, without limiting the generality of the foregoing, all equipment or facilities specifically serving the Premises, such as, plumbing, heating, air conditioning, ventilating, electrical, lighting facilities, boilers, fired or unfired pressure vessels, fire hose connections if within the Premises, fixtures, Interior walls, interior surfaces of exterior walls, ceilings, floors, windows, doors, plate glass, and skylights, but excluding any items which are the responsibility of Lessor pursuant to Paragraph 7.2 below. Lessee, in keeping the Premises In good order, condition and repair, shall exercise and perform good maintenance practices. Lessee’s obligations shall include restorations, replacements or renewals when necessary to keep the Premises and all improvements thereon or a part thereof in good order, condition and state of repair. The Lessee’s Obligations shall include maintenance and repair of the Utility Installations and Alterations made by the prior Lessee to the interior of the Premises, as disclosed to the Lessee, specifically the heating, ventilation and air conditioning system serving the warehouse portion of the Premises, the clean room air handlers, and the interior restrooms.

(b) Lessee shall, at Lessee’s sole cost and expense, procure and maintain a contract, with copies to Lessor, in customary form and substance for and with a contractor specializing and experienced In the Inspection, maintenance and service of the heating, air conditioning and ventilation system for the Premises. However, Lessor reserves the right, upon notice to Lessee, to procure and maintain the contract for the heating, air conditioning and ventilating systems, and if Lessor so elects, Lessee shall reimburse Lessor, upon demand, for the cost thereof.

(c) If Lessee fails to perform Lessee’s obligations under Paragraph 7.1, Lessor may enter upon the Premises after ten (10) days’ prior written notice to Lessee (except in the case of an emergency, in which case no notice shall be required), perform such obligations on Lessee’s behalf, and put the Premises in good order, condition and repair, in accordance with Paragraph 13.2 below.

7.2 Lessor’s Obligations. Subject to the provisions pf Paragraph 2.2 (Condition), 2.3 (Compliance with Covenants, Restrictions and Building Codes), 4.2 (Common Area Operating Expenses), 6 (Use), 7.1 (Lessee’s Obligations), 9 (Damage or Destruction) and 14 (Condemnation), Lessor, subject to reimbursement pursuant to Paragraph 4.2, shall keep in good order, condition and repair the foundations, exterior walls, structural condition of interior bearing walls, exterior roof, fire sprinkler and/or standpipe and hose (if located in the Common Areas) or other automatic fire extinguishing system including fire alarm and/or smoke detection systems and equipment, fire hydrants, parking lots, walkways, parkways, driveways, landscaping fences, signs and utility systems serving the Common Areas and all parts thereof, as well as providing the services for which there Is a Common Area Operating Expense pursuant to Paragraph 4.2. Lessor shall not be obligated to paint the exterior or Interior surfaces of exterior walls nor shall Lessor be obligated to maintain, repair or replace windows, doors or plate glass of the Premises. Lessee expressly waives the benefit of any statute now or hereafter In effect which would otherwise afford Lessee the right to make repairs at Lessor’s expense or to terminate this Lease because of Lessor’s failure to keep the Building, Industrial Canter or Common Areas in good order, condition and repair.

(a) Lessor’s Obligations shall include maintenance of all plumbing, heating, ventilation and air conditioning systems servicing the Premises.

7.3 Utility Installations, Trade Fixtures, Alterations.

(a) Definitions; Consent Required. The term “Utility Installations” Is used In this Lease to refer to all air lines, power panels, electrical distribution, security, fire protection systems, communications systems, lighting fixtures, heating, ventilating and air conditioning equipment, plumbing, and fencing In, on or about the Premises. The term “Trade Fixtures” shall mean Lessee’s machinery and equipment which can be removed without doing material damage to the Premises. The term “Alterations” shall mean any modification of the improvements on the Premises which are provided by Lessor under the terms of this Lease, other than Utility Installations or Trade Fixtures. “Lessee-Owned Alterations and/or Utility Installations” are defined as Alterations and/or Utility Installations made by Lessee that are not yet owned by Lessor pursuant to Paragraph 7.4(a). Lessee shall not make nor cause to be made any Alterations or Utility Installations in, on, under or about the Premises without Lessor’s prior written consent. Lessee May, however, make non-structural Utility Installations to the interior of the Premises (excluding the roof) without Lessor’s consent but upon notice to Lessor, so long as they are not visible from the outside of the Premises, do not involve puncturing, relocating or removing the roof or any existing walls, or changing or interfering with the fire sprinkler or fire detection systems and the cumulative cost thereof during the term of this Lease as extended does not exceed $2,500.00.

(b) Consent. Any Alterations or Utility Installations that Lessee shall desire to make and which require the consent of the Lessor shall be presented to Lessor in written form with detailed plans. All consents given by Lessor, whether by virtue of Paragraph 7.3(a) or by subsequent specific consent, shall be deemed conditioned upon: (I) Lessee’s acquiring all applicable permits required by governmental authorities; (Ii) the furnishing of copies of such permits together with a copy of the plans and specifications for the Alteration or Utility Installation to Lessor prior to commencement of the work thereon; and (Iii) the compliance by Lessee with all conditions of said permits In a prompt and expeditious manner. Any Alterations or Utility Installations by Lessee during the term of this Lease shall be done in a good and workmanlike manner, with good and sufficient materials, and be In compliance with all Applicable Requirements. Lessee shall promptly upon completion thereof furnish Lessor with as-built plans and specifications therefore. Lessor may, (but without obligation to do so) condition its consent to any requested Alteration or Utility Installation that costs $2,500.00 or more upon Lessee’s providing Lessor with a lien and completion bond In an amount equal to one and one-half times the estimated cost of such Alteration or Utility Installation.

 

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(c) Lien Protection. Lessee shall pay when due all claims for labor or materials furnished or alleged to have been furnished to or for Lessee at or for use on the Premises, which claims are or may be secured by any mechanic’s or material man’s lien against the Premises or any Interest therein. Lessee shall give Lessor not less than ten (10) days’ notice prior to the commencement of any work In, on, or about the Premises, and Lessor shall have the right to post notices of non-responsibility In or on the Premises as provided by law. If Lessee shall, in good faith, contest the validity of any such lien, claim or demand, then Lessee shall, at its sole expense, defend and protect Itself, Lessor and the Premises against the same and shall pay and satisfy any such adverse judgment that may be rendered thereon before the enforcement thereof against the Lessor or the Premises. It Lessor shall require, Lessee shall furnish to Lessor a surely bond satisfactory to Lessor in an amount equal to one and one-half times the amount of such contested lien claim or demand, indemnifying Lessor against liability for the same, as required by law for the holding of the Premises free from the effect of such lien or claim. In addition, Lessor may require Lessee to pay Lessor’s attorneys’ fees and costs in participating in such action If Lessor shall decide it Is to Its best Interest to d:) so.

7.4 Ownership, Removal, Surrender, and Restoration.

(a) Ownership. Subject to Lessor’s right to require their removal and, o cause Lessee to become the owner thereof as hereinafter provided in this Paragraph 7.4, all Alterations and Utility Installations made to the Premises by Lessee shall be the property of and owned by Lessee, but considered a part of the Premises. Lessor may, at any time and at its option, elect in writing to Lessee to be the owner of all or any specified part of the Lessee-Owned Alterations and Utility Installations. Unless otherwise instructed per Subparagraph 7.4(b) hereof, all Lessee-Owned Alterations and Utility Installations shall, at the expiration or earlier termination of this Lease, become the property of Lessor and remain upon the Premises and be surrendered with the Premises by Lessee. Notwithstanding the foregoing, Lessee shall be deemed the owner of any power generator installation on or about the Premises.

(b) Removal. Unless otherwise agreed in writing, Lessor may require that any or all Lessee-Owned Alterations or Utility Installations be removed by the expiration or earlier termination of this Lease, notwithstanding that their installation may have been consented to by Lessor. Lessor may require the removal at any time of all or any part of any Alterations or Utility Installations made without the required consent of Lessor.

(c) Surrender/Restoration. Lessee shall surrender the Premises by the end of the last day of the Lease term or any earlier termination date, clean and free of debris and in good operating order, condition and state of repair, ordinary wear and tear excepted. Ordinary wear and tear shall not include any damage or deterioration that would have been prevented by good maintenance practice or by Lessee performing all of Its obligations under this Lease. Except as otherwise agreed or specified herein, the Premises as surrendered, shall Include the Alterations and Utility Installations. The obligation of Lessee shall Include the repair of any damage occasioned by the installation, maintenance or removal of Lessee’s Trade Fixtures, furnishings, equipment, and Lessee-Owned Alterations and Utility Installations, as well as the removal of any storage tank Installed by or for Lessee, and the removal, replacement, or remediation of any soil, material or ground water contaminated by Lessee, all as may then be required by Applicable Requirements and/or good practice. Lessee’s Trade Fixtures shall remain the property of Lessee and shall be removed by Lessee subject to its obligation to repair and restore the Premises per this Lease.

8. Insurance; Indemnity.

8.1 Payment of Premium Increases.

(a) As used herein, the term “Insurance Cost Increase” is defined as. any increase In the actual cost of the insurance applicable to the Building and required to be carried by Lessor pursuant to Paragraphs 8.2(b), 8.3(a) and 8.3(b), (“Required Insurance”), over and above the Base Premium, as hereinafter defined, calculated on an annual basis. “Insurance Cost Increase” shall Include, but not be limited to, requirements of the holder of a mortgage or deed of trust covering the Premises, Increased valuation of the Promises, and/or a general premium rate Increase. he term ‘Insurance Cost Increase” shall not, however, Include any premium increases resulting from the nature of the occupancy of any other lessee of the Building. If the parties Insert a dollar amount In Paragraph 1.9, such amount shall be considered the “Base Premium.” If a dollar amount has not been Inserted In Paragraph 1.9 and If the Building has been previously occupied during the twelve (12) month period immediately preceding the Commencement Date, the ‘Base Premium” shall be the annual premium applicable to such twelve (12) month period. If the Building was not fully occupied during such twelve (.12) month period, the “Base Premium” shall be the lowest annual premium reasonably obtainable for the Required Insurance as of the Commencement Date, assuming the most nominal use possible of the Building. In no event, however, shall Lessee be responsible for any portion of the premium cost attributable to liability Insurance coverage In excess of $1,000,000 procured under Paragraph 8.2(b).

(b) Lessee shall pay any Insurance Cost Increase to Lessor pursuant to Paragraph 4.2. Premiums for policy periods commencing prior to, or extending beyond, the term of this Lease shall be prorated to coincide with the corresponding Commencement Date or Expiration Date.

8.2 Liability Insurance.

(a) Carried by Lessee. Lessee shall obtain and keep In force during the, term of this Lease a Commercial General Liability policy of insurance protecting Lessee, Lessor and any Lender(s) whose names have been provided to Lessee in writing (as additional Insured) against claims for bodily Injury, personal Injury and property damage based upon, Involving or arising out of the ownership, use, occupancy or maintenance of the Premises and all areas appurtenant thereto. Such insurance shall be on an occurrence basis providing single limit coverage in an amount not less than $1,000,000 per occurrence with an “Additional Insured-Managers or Lessor of Premises” endorsement and contain the “Amendment of the Pollution Exclusion” endorsement for damage caused by heat, smoke or fumes from a hostile fire. The policy shall not contain any Infra-insured exclusions as between Insured persons or organizations, but shall Include coverage for liability assumed under this Lease as an “Insured contract” for the performance o’” Lessee’s indemnity obligations under this Lease. The limits of said insurance required by this Lease or as carried by Lessee shall not, however, limit the liability. A Lessee nor relieve Lessee of any obligation hereunder. All insurance to be carried by Lessee shall be primary to and not contributory with any similar insurance carried by Lessor, whose Insurance shall be considered excess insurance only.

(b) Carried by Lessor. Lessor shall also maintain liability insurance described in Paragraph 8.2(a) above, in addition to and not in lieu of, the insurance required to be maintained by Lessee. Lessee shall not be named as an additional insured therein.

8.3 Property Insurance-Building, Improvements end Rental Value.

(a) Building and Improvements. Lessor shall obtain and keep In force during the term of this Lease a policy or policies in the name of Lessor, with loss payable to Lessor and to any Lender(s), Insuring against loss or damage to the Premises. Such insurance shall be for full replacement cost, as the same shall exist from time to time, or the amount required by any Lender(s), but in no event more than the commercially reasonable and available Insurable value thereof If, by reason of the unique nature or age of the Improvements involved, such latter amount Is less than full replacement cost. Lessee-Owned Alterations and Utility Installations, Trade Fixtures and Lessee’s personal property shall be insured by Lessee pursuant to Paragraph 8.4. If the coverage Is available and commercially appropriate, Lessor’s policy or policies shall insure against all risks of direct physical loss or damage (except the perils of flood and/or earthquake unless required by a Lender or included in the Base Premium), including coverage for any additional costs resulting from debris removal and reasonable amounts of coverage for the enforcement of any ordinance or law regulating the reconstruction or replacement of any undamaged sections of the Building required to be demolished or removed by reason of the enforcement of any building, zoning, safety or land use laws as the result of a covered loss, but not including plate glass insurance. Said policy or policies shall also contain an agreed valuation provision in lieu of any co-insurance clause, waiver of subrogation, and inflation guard protection causing an increase in the annual property insurance coverage amount by a factor of not less than the adjusted U.S. Department of Labor Consumer Price Index for All Urban Consumers for the city nearest to where the Premises are located.

 

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(b) Rental Value. Lessor shall also obtain and keep In force during the term of this Lease a policy or policies In the name of Lessor, with loss payable to Lessor and any Lender(s), Insuring the loss of the full rental and other charges payable by all lessees of the Building to Lessor for one year (including all Real Property Taxes, insurance costs,. all Common Area Operating Expenses and any scheduled rental Increases). Said Insurance may Provide that In the event the Lease is terminated by reason of an insured loss, the period of indemnity for such coverage shall be extended beyond the date of the completion of repairs or replacement of the Premises, to provide for one full year’s loss of rental revenues from the date of any such loss. Said insurance shall contain an agreed valuation provision in lieu of any co-insurance clause, and the amount of coverage shall be adjusted annually to reflect the projected rental income, Real Property Taxes, insurance premium costs and other expenses, if any, otherwise payable, for the next 12-month period. Common Area Operating Expenses shall include any deductible amount in the event of such loss.

(c) Adjacent Premises. Lessee shall pay for any increase in the premiums for the property insurance of the Building and for the Common Areas or other buildings in the Industrial Center if said increase is caused by Lessee’s acts, omissions, use or occupancy of the premises.

(d) Lessee’s Improvements. Since Lessor is the Insuring Party, Lessor shall not be required to insure Lessee-Owned Alterations and Utility Installations unless the item in question has become the property of Lessor under the terms of this Lease.

8.4 Lessee’s Property Insurance. Subject to the requirements of Paragraph 8.5, Lessee at its cost shall either by separate policy or, at Lessor’s option, by endorsement to a policy already carried, maintain insurance coverage on all of Lessee’s personal property, Trade Fixtures and Lessee-Owned Alterations and Utility Installations in, on, or about the Premises similar in coverage to that carried by Lessor as the Insuring Party under Paragraph 8.3(a). Such insurance shall be full replacement cost coverage with a deductible not to exceed $1,000 per occurrence. The proceeds from any such insurance shall be used by Lessee for the replacement of personal property and the restoration of Trade Fixtures and Lessee-Owned Alterations and Utility Installations. Upon request from Lessor, Lessee shall provide Lessor with written evidence that such insurance is in force.

8.5 Insurance Policies. Insurance required hereunder shall be in companies duly licensed to transact business in the state where the Premises are located, and maintaining during the policy term a “General Policyholders Rating” of at least B+, V, or such other rating as may be required by a Lender, as set forth in the most current issue of “Best’s Insurance Guide.” Lessee shall not do or permit to be done anything which shall invalidate the insurance policies referred to in this Paragraph 8. Lessee shall cause to be delivered to Lessor, within seven (7) days after the earlier of the Early Possession Date or the Commencement Date, certified copies of, or certificates evidencing the existence and amounts of, the insurance required under Paragraph 8.2(a) and 8.4. No such policy shall be cancelable or subject to modification except after thirty (30) days’ prior written notice to Lessor. Lessee shall at least thirty (30) days prior to the expiration of such policies, furnish Lessor with evidence of renewals or “insurance binders” evidencing renewal thereof, or Lessor may order such insurance and charge the cost thereof to Lessee, which amount shall be payable by Lessee to Lessor upon demand.

8.6 Waiver of Subrogation. Without affecting any other rights or remedies, Lessee and Lessor each hereby release and relieve the other, and waive their entire right to recover damages (whether in contract or in tort) against the other, for loss or damage to their property arising out of or incident to the perils required to be insured against under Paragraph 8. The effect of such releases and waivers of the right to recover damages shall not be limited by the amount of insurance carried or required, or by any deductibles applicable thereto. Lessor and Lessee agree to have their respective insurance companies issuing property damage insurance waive any right to subrogation that such companies may have against Lessor or Lessee, as the case may be, so long as the insurance is not invalidated thereby.

8.7 Indemnity. Except for Lessor’s negligence and/or breach of express warranties, Lessee shall indemnify, protect, defend and hold harmless the Premises, Lessor and its agents, Lessor’s master or ground Lessor, partners and Lenders, from and against any and all claims, loss of rents and/or damages, costs, liens, judgments, penalties, loss of permits, attorneys’ and consultants’ fees, expenses and/or liabilities arising out of, involving, or in connection with, the occupancy of the Premises by Lessee, the conduct of Lessee’s business, any act, omission or neglect of Lessee, its agents, contractors, employees or invitees, and out of any Default or Breach by Lessee in the performance in a timely manner of any obligation on Lessee’s part to be performed under this Lease. The foregoing shall include, but not be limited to the defense or pursuit of any claim or any action or proceeding involved therein, and whether or not (in the case of claims made against Lessor) litigated and/or reduced to judgment. In case any action or proceeding be brought against Lessor by reason of any of the foregoing matters, Lessee upon notice from Lessor shall defend the same at Lessee’s expense by counsel reasonably satisfactory to Lessor and Lessor shall cooperate with Lessee in such defense. Lessor need not have first paid any such claim in order to be so indemnified.

8.8 Exemption of Lessor from Liability. Lessor shall not be liable for injury or damage to the person or goods, wares, merchandise or other property of Lessee, Lessee’s employees, contractors, invitees, customers, or any other person in or about the Premises, whether such damage or injury is caused by or results from fire, steam, electricity, gas, water or rain, or from the breakage, leakage, obstruction or other defects of pipes, fire sprinklers, wires, appliances, plumbing, air conditioning or lighting fixtures, or from any other cause, whether said injury or damage results from conditions arising upon the Premises or upon other portions of the Building of which the Premises are a part, from other sources or places, and regardless of whether the cause of such damage or injury or the means of repairing the same is accessible or not. Lessor shall not be liable for any damages arising from any act or neglect of any other lessee of Lessor nor from the failure by Lessor to enforce the provisions of any other lease in the Industrial Center. Notwithstanding Lessor’s negligence or breach of this Lease, Lessor shall under no circumstances be liable for injury to Lessee’s business or for any loss of income or profit therefrom.

9. Damage or Destruction.

9.1 Definitions.

(a) “Premises Partial Damage” shall mean damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations, the repair cost of which damage or destruction is less than fifty percent (50%) of the then Replacement Cost (as defined in Paragraph 9.1(d)) of the Premises (excluding Lessee-Owned Alterations and Utility Installations and Trade Fixtures) immediately prior to such damage or destruction.

(b) “Premises Total Destruction” shall mean damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations, the repair cost of which damage or destruction is fifty percent (50%) or more of the then Replacement Cost of the Premises (excluding Lessee-Owned Alterations and Utility Installations and Trade Fixtures) immediately prior to such damage or destruction. In addition, damage or destruction to the Building, other than Lessee Owned Alterations and Utility Installations and Trade Fixtures of any lessees of the Building, the cost of which damage or destruction is fifty percent (50%) or more of the then Replacement Cost (excluding Lessee-Owned Alterations and Utility Installations and Trade Fixtures of any lessees of the Building) of the Building shall, at the option of Lessor, be deemed to be Premises Total Destruction.

(c) “Insured Loss” shall mean damage or destruction to the Premises, other than Lessee-Owned Alterations and Utility Installations and Trade Fixtures, which was caused by an event required to be covered by the insurance described in Paragraph 8.3(a) irrespective of any deductible amounts or coverage limits involved.

(d) “Replacement Cost” shall mean the cost to repair or rebuild the improvements owned by Lessor at the time of the occurrence to their condition existing immediately prior thereto, including demolition, debris removal and upgrading required by the operation of applicable building codes, ordinances or laws, and without deduction for depreciation.

(e) “Hazardous Substance Condition” shall mean the occurrence or discovery of a condition involving the presence of, or a contamination by, a Hazardous Substance as defined in Paragraph 6,2(a), in, on, or under the Premises.

 

 

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9.2 Premises Partial Damage-Insured Loss. If Premises Partial Damage that is an Insured Loss occurs, then Lessor shall, at Lessor’s expense, repair such damage (but not Lessee’s Trade Fixtures or Lessee-Owned Alterations and Utility Installations) as soon as reasonably possible and this Lease shall continue in full force and effect. In the event, however, that there is a shortage of insurance proceeds and such shortage is due to the fact that, by reason of the unique nature of the improvements in the Premises, full replacement cost insurance coverage was not commercially reasonable and available, Lessor shall have no obligation to pay for the shortage in insurance proceeds or to fully restore the unique aspects of the Premises unless Lessee provides Lessor with the funds to cover same, or adequate assurance thereof, within ten (10) days following receipt of written notice of such shortage and request therefore. If Lessor receives said funds or adequate assurance thereof within said ten (10) day period, Lessor shall complete them as soon as reasonably possible and this Lease shall remain in full force and effect. If Lessor does not receive such funds or assurance within said period, Lessor may nevertheless elect by written notice to Lessee within ten (10) days thereafter to make such restoration and repair as is commercially reasonable with Lessor paying any shortage in proceeds, in which case this Lease shall remain in full force and effect. If Lessor does not receive such funds or assurance within such ten (10) day period, and if Lessor does not so elect to restore and repair, then this Lease shall terminate sixty (60) days following the occurrence of the damage or destruction. Unless otherwise agreed, Lessee shall in no event have any right to reimbursement from Lessor for any funds contributed by Lessee to repair any such damage or destruction. Premises Partial Damage due to flood or earthquake shall be subject to Paragraph 9.3 rather than Paragraph 9.2 notwithstanding that there may be some insurance coverage, but the net proceeds of any such insurance shall be made available for the repairs if made by either Party.

9.3 Partial Damage-Uninsured Loss. If Premises Partial Damage that is not an Insured Loss occurs, unless caused by a negligent or willful act of Lessee (in which event Lessee shall make the repairs at Lessee’s expense and this Lease shall continue in full force and effect), Lessor may at Lessor’s option, either (i) repair such damage as soon as reasonably possible at Lessor’s expense, in which event this Lease shall continue in full force and effect, or (ii) give written notice to Lessee within thirty (30) days after receipt by Lessor of knowledge of the occurrence of such damage of Lessor’s desire to terminate this Lease as of the date sixty (60) days following the date of such notice. In the event Lessor elects to give such notice of Lessor’s intention to terminate this Lease, Lessee shall have the right within ten (10) days after the receipt of such notice to give written notice to Lessor of Lessee’s commitment to pay for the repair of such damage totally at Lessee’s expense and without reimbursement from Lessor. Lessee shall provide Lessor with the required funds or satisfactory assurance thereof within thirty (30) days following such commitment from Lessee. In such event this Lease shall continue in full force and effect, and Lessor shall proceed to make such repairs as soon as reasonably possible after the required funds are available. If Lessee does not give such notice and provide the funds or assurance thereof within the times specified above, this Lease shall terminate as of the date specified in Lessor’s notice of termination.

9.4 Total Destruction. Notwithstanding any other provision hereof, if Premises Total Destruction occurs (including any destruction required by any authorized public authority), this Lease shall terminate sixty (60) days following the date of such Premises Total Destruction, whether or not the damage or destruction is an Insured Loss or was caused by a negligent or willful act of Lessee. In the event, however, that the damage or destruction was caused by Lessee, Lessor shall have the right to recover Lessor’s damages from Lessee except as released and waived in Paragraph 9.7.

9.5 Damage Near End of Term. If at any time during the last six (6) months of the term of this Lease there is damage for which the cost to repair exceeds one month’s Base Rent, whether or not an insured Loss, Lessor may, at Lessor’s option, terminate this Lease effective sixty (60) days following the date of occurrence of such damage by giving written notice to Lessee of Lessor’s election to do so within thirty (30) days after the date of occurrence of such damage. Provided, however, if Lessee at that time has an exercisable option to extend this Lease or to purchase the Premises, then Lessee may preserve this Lease by (a) exercising such option, and (b) providing Lessor with any shortage in insurance proceeds (or adequate assurance thereof) needed to make the repairs on or before the earlier of (i) the date which is ten (10) days after Lessee’s receipt of Lessor’s written notice purporting to terminate this Lease, or (ii) the day prior to the date upon which such option expires. If Lessee duly exercises such option during such period and provides Lessor with funds (or adequate assurance thereof) to cover any shortage in insurance proceeds, Lessor shall, at Lessor’s expense repair such damage as soon as reasonably possible and this Lease shall continue in full force and effect. If Lessee fails to exercise such option and provide such funds or assurance during such period. then this Lease shall terminate as of the date set forth in the first sentence of this Paragraph 9.5.

9.6 Abatement of Rent; Lessee’s Remedies

(a) In the event of (i) Premises Partial Damage or (ii) Hazardous Substance Condition for which Lessee is not legally responsible, the Base Rent, Common Area Operating Expenses and other charges, if any, payable by Lessee hereunder for the period during which such damage or condition, its repair, remediation or restoration continues, shall be abated in proportion to the degree to which Lessee’s use of the Premises is impaired, but not in excess of proceeds from insurance required to be carried under Paragraph 8.3(b). Except for abatement of Base Rent, Common Area Operating Expenses and other charges, if any, as aforesaid, all other conditions of Lessee hereunder shall be performed by Lessee, and Lessee shall have no claim against Lessor for any damage suffered by reason of any such damage, destruction, repair, remediation or restoration.

(b) If Lessor shall be obligated to repair or restore the Premises under the provisions of this Paragraph 9 and shall not commence, in a substantial and meaningful way, the repair or restoration of the Premises within ninety (90) days after such obligation shall accrue, Lessee may, at any time prior to the commencement of such repair or restoration, give written notice to Lessor and to any Lenders of which Lessee has actual notice of Lessee’s election to terminate this Lease on a date not less than sixty (60) days following the giving of such notice. If Lessee gives such notice to Lessor and such Lenders and such repair or restoration is not commenced within thirty (30) days after receipt of such notice, this Lease shall terminate as of the date specified in said notice. If Lessor or a Lender commences the repair or restoration of the Premises within thirty (30) days after the receipt of such notice. this Lease shall continue in full force and effect. “Commence” as used in this Paragraph 9.6 shall mean either the unconditional authorization of the preparation of the required plans, or the beginning of the actual work on the Premises, whichever occurs first.

9.7 Hazardous Substance Conditions. If a Hazardous Substance Condition occurs, unless Lessee is legally responsible therefore (in which case Lessee shall make the investigation and remediation thereof required by Applicable Requirements and this Lease shall continue in full force and effect, but subject to Lessor’s rights under Paragraph 6.2(c) and Paragraph 13), Lessor may at Lessor’s option either (i) investigate and remediate such Hazardous Substance Condition, if required, as soon as reasonably possible at Lessor’s expense, in which event this Lease shall continue in full force and effect, or (ii) if the estimated cost to investigate and remediate such condition exceeds twelve (12) times the then monthly Base Rent or $100,000 whichever is greater, give written notice to Lessee within thirty (30) days after receipt by Lessor of knowledge of the occurrence of such Hazardous Substance Condition of Lessor’s desire to terminate this Lease as of the data sixty (60) days following the date of such notice. In the event Lessor elects to give such notice of Lessor’s intention to terminate this Lease, Lessee shall have the right within ten (10) days after the receipt of such notice to give written notice to Lessor of Lessee’s commitment to pay for the excess costs of (a) investigation and remediation of such Hazardous Substance Condition to the extent required by Applicable Requirements, over (b) an amount equal to twelve (12) times the then monthly Base Rent or $100,000, whichever is greater. Lessee shall provide Lessor with the funds required of Lessee or satisfactory assurance thereof within thirty (30) days following said commitment by Lessee. In such event this Lease shall continue in full force and effect, and Lessor shall proceed to make such investigation and remediation as soon as reasonably possible after the required funds are available. If Lessee does not give such notice and provide the required funds or assurance thereof within the time period specified above, this Lease shall terminate as of the date specified in Lessor’s notice of termination.

9.8 Termination-Advance Payments. Upon termination of this Lease pursuant to this Paragraph 9, Lessor shall return to Lessee any advance payment made by Lessee to Lessor and so much of Lessee’s Security Deposit as has not been, or is not then required to be, used by Lessor under the terms of this Lease.

9.9 Waiver of Statutes. Lessor and Lessee agree that the terms of this Lease shall govern the effect of any damage to or destruction of the Premises and the Building with respect to the termination of this Lease and hereby waive the provisions of any present or future statute to the extent it is inconsistent herewith.

10. Real Property Taxes.

 

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10.1 Payment of Taxes. Lessor shall pay the Real Property Taxes, as defined in Paragraph 10.2(a), applicable to the Industrial Center, and except as otherwise provided in Paragraph 10.3, any increases in such amounts over the Base Real Property Taxes shall be included in the calculation of Common Area Operating Expenses in accordance with the provisions of Paragraph 4.2.

 

10.2

Real Property Tax Definitions.

(a) As used herein, the term Real Property Taxes shall include any form of real estate tax or assessment, general, special, ordinary or extraordinary, and any license fee, commercial rental tax, improvement bond or bonds, levy or tax (other than inheritance, personal income or estate taxes) imposed upon the Industrial Center by any authority having the direct or indirect power to tax, including any city, state or federal government, or any school, agricultural, sanitary, fire, street, drainage, or other improvement district thereof, levied against any legal or equitable interest of Lessor in the Industrial Center or any portion thereof, Lessor’s right to rent or other income therefrom, and/or Lessor’s business of leasing the Premises. The term “Real Property Taxes shall also include any tax, fee, levy, assessment or charge, or any increase therein, imposed by reason. of events occurring, or changes in Applicable Law taking effect, during the term of this Lease, including but not limited to a change in the ownership of the Industrial Center or in the improvements thereon, the execution of this Lease, or any modification, amendment or transfer thereof, and whether or not contemplated by the Parties.

(b) As used herein, the term Base Real Property Taxes shall be the amount of Real Property Taxes, which are assessed against the Premises, Building or Common Areas in the calendar year during which the Lease is executed. In calculating Real Property Taxes for any calendar year, the Real Property Taxes for any real estate tax year shall be included in the calculation of Real Property Taxes for such calendar year based upon the number of days which such calendar year and tax year have in common.

10.3 Additional Improvements. Common Area Operating Expenses shall not include Real Property Taxes specified in the tax assessor’s records and work sheets as being caused by additional improvements placed upon the Industrial Center by other lessees or by Lessor for the exclusive enjoyment of such other lessees. Notwithstanding Paragraph 10.1 hereof, Lessee shall, however, pay to Lessor at the time Common Area Operating Expenses are payable under Paragraph 4.2, the entirety of any increase in Real Property Taxes if assessed solely by reason of Alterations, Trade Fixtures or Utility Installations placed upon the Premises by Lessee or at Lessee’s request.

10.4 Joint Assessment. If the Building is not separately assessed. Real Property Taxes allocated to the Building shall be an equitable proportion of the Real Properly Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be determined by Lessor from the respective valuations assigned in the assessor’s work sheets or such other information as may be reasonably available. Lessor’s reasonable determination thereof, in good faith, shall be conclusive.

10.5 Lessee’s Property Taxes. Lessee shall pay prior to delinquency all taxes assessed against and levied upon Lessee-Owned Alterations and Utility Installations, Trade Fixtures, furnishings, equipment and all personal property of Lessee contained in the Premises or stored within the Industrial Center. When possible, Lessee shall cause its Lessee-Owned Alterations and Utility Installations, Trade Fixtures, furnishings, equipment and all other personal property to be assessed and billed separately from the real property of Lessor. If any of Lessee’s said property shall be assessed with Lessor’s real property, Lessee shall pay Lessor the taxes attributable to Lessee’s property within ten (10) days after receipt of a written statement setting forth the taxes applicable to Lessee’s property.

11. Utilities. Lessee shall pay directly for all utilities and services supplied to the Premises, including but not limited to electricity, telephone, security, gas and cleaning of the Premises, together with any taxes thereon. If any such utilities or services are not separately metered to the Premises or separately billed to the Premises, Lessee shall pay to Lessor a reasonable proportion to be determined by Lessor of alt such charges jointly metered or billed with other premises in the Building, in the manner and within the time periods set forth in Paragraph 4.2(d).

12. Assignment and Subletting.

 

12.1

Lessor’s Consent Required.

(a) Lessee shall not voluntarily or by operation of law assign, transfer, mortgage or otherwise transfer or encumber (collectively, “assign”) or sublet all or any part of Lessee’s interest in this Lease or in the Premises without Lessor’s prior written consent given under and subject to the terms of Paragraph 36.

(b) A change in the control of Lessee shall constitute an assignment requiring Lessor’s consent. The transfer, on a cumulative basis, of twenty-five percent (25%) or more of the voting control of Lessee shall constitute a change in control for this purpose.

(c) The involvement of Lessee or its assets in any transaction, or series of transactions (by way of merger, sale acquisition financing, refinancing, transfer, leveraged buy-out or otherwise), whether or not a formal assignment or hypothecation of this Lease or Lessee’s assets occurs, which results or will result in a reduction of the Net Worth of Lessee, as hereinafter defined, by an amount equal to or greater than twenty-five percent (25%) of such Net Worth of Lessee as it was represented to Lessor at the time of full execution and deliver] of this Lease or at the time of the most recent assignment to which Lessor has consented, or as it exists immediately prior to said transaction or transactions constituting such reduction, at whichever time said Net Worth of Lessee was or is greater, shall be considered an assignment of this Lease by Lessee to which Lessor may reasonably withhold its consent. Net Worth of Lessee for purposes of this Lease shall be the net worth of Lessee (excluding any Guarantors) established under generally accepted accounting principles consistently applied.

(d) An assignment or subletting of Lessee’s interest in this Lease without Lessor’s specific prior written consent shall, at Lessor’s option, be a Default curable after notice per Paragraph 13.1, or a non-curable Breach without the necessity of any notice and grace, period. If Lessor elects to treat such unconsented to assignment or subletting as a non-curable Breach, Lessor shall have the right to either: (i) terminate this Lease, or (ii) upon thirty (30) days’ written notice (Lessor’s Notice), increase the monthly Base Rent for the Premises to the greater of the then fair market rental value of the Premises, as reasonably determined by Lessor, or one hundred ten percent (110%) of the Base Rent then in effect. Pending determination of the new fair market rental value, if disputed by Lessee, Lessee shall pay the amount set forth in Lessor’s Notice, with any overpayment credited against the next installment(s) of Base Rent coming due, and any underpayment for the period retroactively to the effective date of the adjustment being due and payable immediately upon the determination thereof. Further, in the event of such Breach and rental adjustment, (i) the purchase price of any option to purchase the Premises held by Lessee shall be subject to similar adjustment to the then fair market value as reasonably determined by Lessor (without the Lease being considered an encumbrance or any deduction for depreciation or obsolescence, and considering the Premises at its highest and best use and in good condition) or one hundred ten percent (110%) of the price previously in effect, (ii) any index-oriented rental or price adjustment formulas contained in this Lease shall be adjusted to require that the base index be determined with reference to the index applicable to the time of such adjustment, and (iii) any fixed rental adjustments scheduled during the remainder of the Lease term shall be increased in the same ratio as the new rental bears to the Base Rent in effect immediately prior to the adjustment specified in Lessor’s Notice.

(e) Lessee’s remedy for any breach of this Paragraph 12.1 by Lessor shall be limited to compensatory damages and/or injunctive relief.

(f) Lessor’s consent shall not be required for any of the following: (i) change in domicile of the Lessee (e.g., a change from a foreign entity to a United States entity); (ii) any change in form of the Lessee which will not modify the ownership interests therein; (c) assignment or sublease to a subsidiary of the Lessee.

 

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12.2

Terms and Conditions Applicable to Assignment and Subletting.

(a) Regardless of Lessor’s consent, any assignment or subletting shall not (i) be effective without the express written assumption by such assignee or sublessee of the obligations of Lessee under this Lease, (ii) release Lessee of any obligations hereunder, nor (iii) alter the primary liability of Lessee for the payment of Base Rent and other sums due Lessor hereunder or for the performance of any other obligations to be performed by Lessee under this Lease.

 

  (a)

Lessor may accept any rent or performance of Lessee’s obligations from any person other than Lessee pending approval or disapproval of an assignment. Neither a delay in the approval or disapproval of such assignment nor the acceptance of any rent for performance shall constitute a waiver or estoppel of Lessor’s right to exercise itsd remedies for the Default or Breach by Lessee of any of the terms, covenants or conditions of this Lease.

 

  (b)

The consent of Lessor to any assignment or subletting shall not constitute a consent to any subsequent assignment or subletting by Lessee or to any subsequent or successive assignment or subletting by the assignee or sublessee. However, Lessor may consent to subsequent sublettings and assignments of the sublease or any amendments or modifications thereto without notifying Lessee or anyone else liable under this Lease or the sublease and without obtaining their consent, and such action shall not relieve such persons from liability under this Lease or the sublease.

(d) In the event of any Default or Breach of Lessee’s obligation under this Lease Lessor may proceed directly against Lessee, any Guarantors or anyone else responsible for the performance of the Lessee’s obligations under this Lease, including any sublessee, without first exhausting Lessor’s remedies against any other person or entity responsible therefor to Lessor, or any security held by Lessor.

(e) Each request for consent to an assignment or subletting shall be in writing, accompanied by information relevant to Lessor’s determination as to the financial and operational responsibility and appropriateness of the proposed assignee or sublessee, including but not limited to the intended use and/or required modification of the Premises, if any, together with a non-refundable deposit of $1,000 or ten percent (10%) of the monthly Base Rent applicable to the portion of the Premises which is the subject of the proposed assignment or sublease, whichever is greater, as reasonable consideration for Lessor’s considering and processing the request for consent. Lessee agrees to provide Lessor with such other or additional information and/or documentation as may be reasonably requested by Lessor.

(f) Any assignee of, or sublessee under, this Lease shall by reason of accepting such assignment or entering into such sublease, be deemed for the benefit of Lessor, to have assumed and agreed to conform and comply with each and every term, covenant, condition and obligation herein to be observed or performed by Lessee during the term of said assignment or sublease, other than such obligations as are contrary to or inconsistent with provisions of an assignment or sublease to which Lessor has specifically consented in writing.

(g) The occurrence of a transaction described in Paragraph 12.2(c) shall give Lessor the right (but not the obligation) to require that the Security Deposit be increased by an amount equal to six (6) times the then monthly Base Rent, and Lessor may make the actual receipt by Lessor of the Security Deposit increase a condition to Lessor’s consent to such transaction.

(h) Lessor, as a condition to giving its consent to any assignment or subletting, may require that the amount and adjustment schedule of the rent payable under this Lease be adjusted to what is then the market value and/or adjustment schedule for property similar to the Premises as then constituted, as determined by Lessor.

12.3 Additional Terms and Conditions Applicable to Subletting. The following terms and conditions shall apply to any subletting by Lessee of all or any part of the Premises and shall be deemed included in all subleases under this Lease whether or not expressly incorporated therein:

(a) Lessee hereby assigns and transfers to Lessor all of Lessee’s interest in all rentals and income arising from any sublease of all or a portion of the Premises heretofore or hereafter made by Lessee, and Lessor may collect such rent and income and apply same toward Lessee’s obligations under this Lease; provided, however, that until a Breach (as defined in Paragraph 13.1) shall occur in the performance of Lessee’s obligations under this Lease, Lessee may, except as otherwise provided in this Lease, receive, collect and enjoy the rents accruing under such sublease. Lessor shall not, by reason of the foregoing provision or any other assignment of such sublease to Lessor, nor by reason of the collection of the rents from a sublessee, be deemed liable to the sublessee for any failure of Lessee to perform and comply with any of Lessee’s obligations to such sublessee under such Sublease. Lessee hereby irrevocably authorizes and directs any such sublessee, upon receipt of a written notice from Lessor stating that a Breach exists in the performance of Lessee’s obligations under this Lease, to pay to Lessor the rents and other charges due and to become due under the sublease. Sublessee shall rely upon any such statement and request from Lessor and shall pay such rents and other charges to Lessor without any obligation or right to inquire as to whether such Breach exists and notwithstanding any notice from or claim from Lessee to the contrary. Lessee shall have no right or claim against such sublessee, or, until the Breach has been cured, against Lessor, for any such rents and other charges so paid by said sublessee to Lessor.

(b) In the event of a Breach by Lessee in the performance of its obligations under this Lease, Lessor, at its option and without any obligation to do so, may require any sublessee to attorn to Lessor, in which event Lessor shall undertake the obligations of the sublessor under such sublease from the time of the exercise of said option to the expiration of such sublease; provided, however, Lessor shall not be liable for any prepaid rents or security deposit paid by such sublessee to such sublessor or for any other prior defaults or breaches of such sublessor under such sublease.

(c) Any matter or thing requiring the consent of the sublessor under a sublease shall also require the consent of Lessor herein.

(d) No sublessee under a sublease approved by Lessor shall further assign or sublet all or any part of the Premises without Lessor’s prior written consent.

(e) Lessor shall deliver a copy of any notice of Default or Breach by Lessee to the sublessee, who shall have the right to cure the Default of Lessee within the grace period, if any, specified in such notice. The sublessee shall have a right of reimbursement and offset from and against Lessee for any such Defaults cured by the sublessee.

13. Default; Breach; Remedies.

13.1 Default; Breach. Lessor and Lessee agree that if an attorney is consulted by Lessor in connection with a Lessee Default or Breach (as hereinafter defined), $350.00 is a reasonable minimum sum per such occurrence for legal services and costs in the preparation and service of a notice of Default, and that Lessor may include the cost of such services and costs in said notice as rent due and payable to cure said default. A Default by Lessee is defined as a failure by Lessee to observe, comply with or perform any of the terms, covenants, conditions or rules applicable to Lessee under this Lease. A Breach by Lessee is defined as the occurrence of any one or more of the following Defaults, and, where a grace period for cure after notice is specified herein, the failure by Lessee to cure such Default prior to the expiration of the applicable grace period, and shall entitle Lessor to pursue the remedies set forth in Paragraphs 13.2 and/or 13.3:

(a) The vacating of the Premises without the intention to reoccupy same, or the abandonment of the Premises.

(b) Except as expressly otherwise provided in this Lease, the failure by Lessee to make any payment of Base Rent, Lessee’s Share of Common Area Operating Expenses, or any other monetary payment required to be made by Lessee hereunder as and when due the failure by Lessee to provide Lessor with reasonable evidence of insurance or surety bond required under this Lease, or the failure of Lessee to fulfill any obligation under this Lease which endangers or threatens life or property, where such failure continues for a period of three (3) days following written notice thereof by or on behalf of Lessor to Lessee.

 

 

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(c) Except as expressly otherwise provided in this Lease, the failure by Lessee to provide Lessor with reasonable written evidence (in duly executed original form, if applicable) of (i) compliance with Applicable Requirements per Paragraph 6.3, (ii) the inspection, maintenance and service contracts required under Paragraph 7.1(b), (iii) the rescission of an unauthorized assignment or subletting per Paragraph 12.1, (iv) a Tenancy Statement per Paragraphs 16 or 37, (v) the subordination or non-subordination of this Lease per Paragraph 30, (vi) the guaranty of the performance of Lessee’s obligations under this Lease if required under Paragraphs 1.11 and 37, (vii) the execution of any document requested under Paragraph 42 (easements), or (viii) any other documentation or information which Lessor may reasonably require of Lessee under the terms of this lease, where any such failure continues for a period of ten (10) days following written notice by or on behalf of Lessor to Lessee.

(d) A Default by Lessee as to the terms, covenants, conditions or provisions of this Lease, or of the rules adopted under Paragraph 40 hereof that are to be observed, complied with or performed by Lessee, other than those described in Subparagraphs 13.1(a), (b) or (c), above, where such Default continues for a period of thirty (30) days after written notice thereof by or on behalf of Lessor to Lessee; provided, however, that if the nature of Lessee’s Default is such that more than thirty (30) days are reasonably required for its cure, then it shall not be deemed to be a Breach of this Lease by Lessee if Lessee commences such cure within said thirty (30) day period and thereafter diligently prosecutes such cure to completion.

(e) The occurrence of any of the following events: (i) the making by Lessee of any general arrangement or assignment for the benefit of creditors; (ii) Lessee’s becoming a “debtor” as defined in 11 U.S. Code Section 101 or any successor statute thereto (unless, in the case of a petition filed against Lessee, the same is dismissed within sixty (60) days); (iii) the appointment of a trustee or receiver to take possession of substantially all of Lessee’s assets located at the Premises or of Lessee’s interest in this Lease, where possession is not restored to Lessee within thirty (30) days; or (iv) the attachment, execution or other judicial seizure of substantially all of Lessee’s assets located at the Premises or of Lessee’s interest in this Lease, where such seizure is not discharged within thirty (30) days; provided, however, in the event that any provision of this Subparagraph 13.1 (e) is contrary to any applicable law, such provision shall be of no force or effect, and shall not affect the validity of the remaining provisions.

(f) The discovery by Lessor that any financial statement of Lessee or of any Guarantor, given to Lessor by Lessee or any Guarantor, was materially false.

(g) If the performance of Lessee’s obligations under this Lease is guaranteed: (i) the death of a Guarantor, (ii) the termination of a Guarantor’s liability with respect to this Lease other than in accordance with the terms of such guaranty, (iii) a Guarantor’s becoming insolvent or the subject of a bankruptcy filing, (iv) a Guarantor’s refusal to honor the guaranty, or (v) a Guarantor’s breach of its guaranty obligation on an anticipatory breach basis, and Lessee’s failure, within sixty (60) days following written notice by or on behalf of Lessor to Lessee of any such event, to provide Lessor with written alternative assurances of security, which, when coupled with the then existing resources of Lessee, equals or exceeds the combined financial resources of Lessee and the Guarantors that existed at the time of execution of this Lease.

13.2 Remedies. If Lessee fails to perform any affirmative duty or obligation of Lessee under this Lease, within ten (10) days after written notice to Lessee (or in case of an emergency, without notice), Lessor may at its option (but without obligation to do so), perform such duty or obligation on Lessee’s behalf, including but not limited to the obtaining of reasonably required bonds, insurance policies, or governmental licenses, permits or approvals. The costs and expenses of any such performance by Lessor shall be due and payable by Lessee to Lessor upon invoice therefor. If any check given to Lessor by Lessee shall not be honored by the bank upon which it is drawn, Lessor, at its own option, may require all future payments to be made under this Lease by Lessee to be made only by cashier’s check. In the event of a Breach of this Lease by Lessee (as defined in Paragraph 13.1), with or without further notice or demand, and without limiting Lessor in the exercise of any right or remedy which Lessor may have by reason of such Breach, Lessor may:

(a) Terminate Lessee’s right to possession of the Premises by any lawful means, in which case this Lease and the term hereof shall terminate and Lessee shall immediately surrender possession of the Premises to Lessor. In such event Lessor shall be entitled to recover from Lessee: (i) the worth at the time of the award of the unpaid rent which had been earned at the time of termination; (ii) the worth at the time of award of the amount by which the unpaid rent which would have been earned after termination until the time of award exceeds the amount of such rental loss that the Lessee proves could have been reasonably avoided; (iii) the worth at the time of award of the amount by which the unpaid rent for the balance of the term after the time of award exceeds the amount of such rental loss that the Lessee proves could be reasonably avoided; and (iv) any other amount necessary to compensate Lessor for all the detriment proximately caused by the Lessee’s failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom, including but not limited to the cost of recovering possession of the Premises, expenses of reletting, including necessary renovation and alteration of the Premises, reasonable attorneys’ fees, and that portion of any leasing commission paid by Lessor in connection with this Lease applicable to the unexpired term of this Lease. The worth at the time of award of the amount referred to in provision (iii) of the immediately preceding sentence shall be computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco or the Federal Reserve Bank District in which the Premises are located at the time of award plus one percent (1%). Efforts by Lessor to mitigate damages caused by Lessee’s Default or Breach of this Lease shall not waive Lessor’s right to recover damages under this Paragraph 13.2. If termination of this Lease is obtained through the provisional remedy of unlawful detainer, Lessor shall have the right to recover in such proceeding the unpaid rent and damages as are recoverable therein, or Lessor may reserve the right to recover all or any part thereof in a separate suit for such rent and/or damages. If a notice and grace period required under Subparagraph 13.1(b), (c) or (d) was not previously given, a notice to pay rent or quit, or to perform or quit, as the case may be, given to Lessee under any statute authorizing the forfeiture of leases for unlawful detainer shall also constitute the applicable notice for grace period purposes required by Subparagraph 13.1(b),(c) or (d). In such case, the applicable grace period under the unlawful detainer statue shall run concurrently after the one such statutory notice, and the failure of Lessee to cure the Default within the greater of the two (2) such grace periods shall constitute both an unlawful detainer and a Breach of this Lease entitling Lessor to the remedies provided for in this Lease and/or by said statute.

(b) Continue the Lease and Lessee’s right to possession in effect (in California under California Civil Code Section 1951.4) after Lessee’s Breach and recover the rent as it becomes due, provided Lessee has the right to sublet or assign, subject only to reasonable limitations. Lessor and Lessee agree that the limitations on assignment and subletting in this Lease are reasonable. Acts of maintenance or preservation, efforts to relet the Premises, or the appointment of a receiver to protect the Lessor’s interest under this Lease, shall not constitute a termination of the Lessee’s right to possession.

(c) Pursue any other remedy now or hereafter available to Lessor under the laws or judicial decisions of the state wherein the Premises are located.

(d) The expiration or termination of this Lease and/or the termination of Lessee’s right to possession shall not relieve Lessee from liability under any indemnity provisions of this Lease as to matters occurring or accruing during the term hereof or by reason of Lessee’s occupancy of the Premises.

13.3 Inducement Recapture In Event of Breach. Any agreement by Lessor for free or abated rent or other charges applicable to the Premises, or for the giving or paying by Lessor to or for Lessee of any cash or other bonus, inducement or consideration for Lessee’s entering into this Lease, all of which concessions are hereinafter referred to as “Inducement Provisions” shall be deemed conditioned upon Lessee’s full and faithful performance of all of the terms, covenants and conditions of this Lease to be performed or observed by Lessee during the term hereof as the same may be extended. Upon the occurrence of a Breach (as defined in Paragraph 13.1) of this Lease by Lessee, any such Inducement Provision shall automatically be deemed deleted from this Lease and of no further force o; effect, and any rent, other charge, bonus, inducement or consideration theretofore abated, given or paid by Lessor under such an Inducement Provision shall be immediately due and payable by Lessee to Lessor, and recoverable by Lessor, as additional rent due under this Lease, notwithstanding any subsequent cure of said Breach by Lessee. The acceptance by Lessor of rent or the cure of the Breach which initiated the operation of this Paragraph 13.3 shall not be deemed a waiver by Lessor of the provisions of this Paragraph 13.3 unless specifically so stated in writing by Lessor at the time of such acceptance.

 

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13.4 Late Charges. Lessee hereby acknowledges that late payment by Lessee to Lessor of rent and other sums due hereunder will cause Lessor to incur costs not contemplated by this Lease, the exact amount of which will be extremely difficult to ascertain. Such cots include, but are not limited to, processing and accounting charges, and late charges which may be imposed upon Lessor by the terms of any ground lease, mortgage or deed of trust covering the Premises. Accordingly, if any installment of rent or other sum due from Lessee shall not be received by Lessor or Lessor’s designee within ten (10) days after such amount shall be due, then, without any requirement for notice to Lessee, Lessee shall pay to Lessor a late charge equal to six percent (6%) of such overdue amount. The parties hereby agree that such late charge represents a fair and reasonable estimate of the costs Lessor will incur by reason of late payment by Lessee. Acceptance of such late charge by Lessor shall in no event constitute a waiver of Lessee’s Default or Breach with respect to such overdue amount, nor prevent Lessor from exercising any of the other rights and remedies granted hereunder. In the event that a late charge is payable hereunder, whether or no; collected, for three (3) consecutive installments of Base Rent, then notwithstanding Paragraph 4.1 or any other provision of this Lease to the contrary. Base Rant shall, at Lessor’s option, become due and payable quarterly in advance.

13.5 Breach by Lessor. Lessor shall not be deemed in breach of this Lease unless Lessor fails within a reasonable time to perform an obligation required to be performed by Lessor. For purposes of this Paragraph 13.5, a reasonable time shall in no event be less than ten (10) days after receipt by Lessor, and by any Lender(s) whose name and address shall have been furnished to Lessee in writing for such purpose, of written notice specifying wherein such obligation of Lessor has not been performed; provided, however, that if the nature of Lessor’s obligation is such that more than thirty (30) days after such notice are reasonably required for its performance, then Lessor shall not be in breach of this Lease if performance is commenced within such thirty (30) day period and thereafter diligently pursued to completion.

14. Condemnation. If the Premises or any portion thereof are taken under the power of eminent domain or sold under the threat of the exercise of said power (all of which are herein called “condemnation”), this Lease shall terminate as to the part so taken as of the date the condemning authority takes title or possession, whichever first occurs. If more than ten percent (10%) of the floor area of the Premise, or more than twenty-five percent (25%) of the portion of the Common Areas designated for Lessee’s parking, is taken by condemnation, Lessee may, at Lessee’s option, to be exercised in writing within ten (10) days after Lessor shall have given Lessee written notice of such taking (or in the absence of such notice, within ten (10) days after the condemning authority shall have taken possession) terminate this Lease as of the date the condemning authority takes such possession. If Lessee does not terminate this Lease in accordance with the foregoing, this Lease shall remain in full force and effect as to the portion of the Premises remaining, except that the Base Rent shall be reduced in the same proportion as the rentable floor area of the Premises taken bears to the total rentable floor area of the Premise. No reduction of Base Rent shall occur if the condemnation does not apply to any portion of the Premises. Any award for the taking of all or any part of the Premises under the power of eminent domain or any payment made under threat of the exercise of such power shall be the property of Lessor, whether such award shall be made as compensation for diminution of value of the leasehold or for the taking of the fee, or as severance damages; provided, however, that Lessee shall be entitled to any compensation, separately awarded to Lessee for Lessee’s relocation expenses and/or loss of Lessee’s Trade Fixtures. In ties event that this Lease is not terminated by reason of such condemnation, Lessor shall to the extent of its net severance damages received, over and above Lessee’s Share of the legal anal other expenses incurred by Lessor in the condemnation natter, repair any damage to the Premises caused by such condemnation authority. Lessee shall be responsible for the payment of any amount in excess of such net severance damages required to complete such repair.

15. Brokers’ Fees.

15.1 Procuring Cause. The Brokers) named in Paragraph 1.10 is/are the procuring cause of this Lease.

15.2 Additional Terms. Unless Lessor and Broker(s) have otherwise agreed in writing, Lessor agrees that: (a) if Lessee exercises any Option (as defined in Paragraph 39.1) granted under this Lease or any Option subsequently granted, or (b) if Lessee acquires any rights to the Premises or other premises in which Lessor has an interest, or (c) if Lessee remains in possession of tile Premises with tile consent of Lesser aft-3i the expiration of the term of this Lease after having failed to exercise an Option, or (d) if said Brokers are the procuring cause of any oilier lease or saie entered into between the Parties pertaining to the Premises and/or any adjacent property in which Lessor has an interest, or (e) if Base Rent is increased, whether by agreement or operation of an escalation c!-use herein, then as to any of said transactions, Lessor shall pay said Broker(s) a fee in accordance with the schedule of said Broker(s) in effect at the time of the execution of this Lease.

15.3 Assumption of Obligations. Any buyer or transferee of lessor’s interest in this Lease whether such transfer is by agreement or by operation of law, shall be deemed to have assumed Lessor’s obligation under this Paragraph 15. Each Broker shall be an intended third party beneficiary of the provisions of Paragraph 1.10 and of this Paragraph 15 to the. extent of its interest in any commission arising from this Lease and may enforce that right directly against Lessor and its successors.

15.4 Representations and Warranties. Lessee and Lessor each represent and warrant to the other that it has had no dealings with any person, firm, broker or finder other than as named in Paragraph 1.10(a) in connection with the negotiation of this Lease and/or the consummation of the transaction, contemplated hereby, and that no broker or other person, firm or entity ether than said named Broker(s) is entitled to any commission or finder’s fee in connection with said transaction. Lessee and Lessor do each hereby agree to indemnify, protect, defend and hold the other harmless from and against liability for compensation or charges which may be claimed by any such unnamed broker, finder or other similar party by reason of any dealings or actions of the indemnifying Party, including any costs, expenses, and/or attorneys’ fees reasonably incurred with respect thereto.

16. Tenancy and Financial Statements.

16.1 Tenancy Statement. Each Party (as Responding Party) shall within ten (10) days after written notice from the other Party (the Requesting Party) execute, acknowledge and deliver to the Requesting Party a statement in writing in a form similar to the then most current “Tenancy Statement” form published by the American Industrial Real Estate Association, plus such additional information, confirmation and/or statements as may be reasonably requested by the Requesting Party.

16.2 Financial Statement. If Lessor desires to finance, refinance, or sell the Premises or the Building, or any part thereof, Lessee and all Guarantors shall deliver to any potential lender or purchaser designated by Lessor such financial statements of Lessee and such Guarantors as may be reasonably required by such lender or purchaser, including but not limited to Lessee’s financial statements for the past three (3) years. All such financial statements shall be received by Lessor and such lender or purchaser in confidence and shall be used only for the purposes herein set forth.

17. Lessor’s Liability. The term Lessor as used herein shall mean the owner or owners at the time in question of the fee title to the Premises. In the event of a transfer of Lessor’s tifle or interest in the Premises or in this Lease, Lessor shall deliver to the transferee or assignee (in cash or by credit) any unused Security Deposit held by Lessor at the time of such transfer or assignment. Except as provided in Paragraph 15.3, upon such transfer or assignment and delivery of the Security Deposit, as aforesaid, the prior Lessor shall be relieved of ail liability with respect to the obligations and/or covenants under this Lease thereafter to be performed by the Lessor. Subject to the foregoing, the obligations and/or covenants in this Lease to be performed by the Lessor shall be binding only upon the Lessor as hereinabove defined.

18. Severability. The invalidity of any provision of this Lease, as determined by a court of competent jurisdiction, shall in no way affect the validity of any other provision hereof.

19. Interest on Past-Due Obligations. Any monetary payment due Lessor hereunder, other than late charges, not received by Lessor within ten (10) days following the date on which it was due, shall bear interest from the date due at the prime rate charged by the largest state chartered bank in the state in which the Premises are located plus four percent (4%) per annum, but not exceeding the maximum rate allowed by law, in addition to the potential late charge provided for in Paragraph 13.4.

 

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20. Time of Essence. Time is of the essence with respect to the performance of all obligations to be performed or observed by the Parties under this Lease.

21. Rent Defined. All monetary obligations of Lessee to Lessor under the terms of this Lease are deemed to be rent.

22. No Prior or other Agreenments; Broker Disclaimer. This Lease contains all agreements between the Parties with respect to any matter mentioned herein, and no other prior or contemporaneous agreement or understanding shall be effective. Lessor and Lessee each represents and warrants to the Brokers that it has made, and is relying solely upon, its own investigation as to the nature, quality, character and financial responsibility of the other Party to this Lease and as to the nature, quality and character of the Premises. Brokers have no responsibility with respect thereto or with respect to any default or breach hereof by either Party. Each Broker shall be an intended third party beneficiary of the provisions of this Paragraph 22.

23. Notices

23.1 Notice Requirements. All notices required or permitted by this Lease shall be in writing and may be delivered in person (by hand or by messenger or courier service) or may be sent by regular, certified or registered mail or U.S. Postal Service Express Mail, with postage prepaid, or by facsimile transmission or electronic mail during normal business hours, and shall be deemed sufficiently given if served in a manner specified in this Paragraph 23. The addresses noted adjacent to a Party’s signature on this Lease shall be that Party’s address for delivery or mailing of notice purposes. Either Party may by written notice to the other specify a different address for notice purposes, except that upon Lessee’s taking possession of the Premises, the Premises shall constitute Lessee’s address for the purpose of mailing or delivering notices to Lessee. A copy of all notices required or permitted to be given to Lessor hereunder shall be concurrently transmitted to such party or parties at such addresses as Lessor may from time to time hereafter designate by written notice to Lessee.

23.2 Date of Notice. Any notice sent by registered or certified mail, return receipt requested, shall be deemed given on the date of delivery shown on the receipt card, or if no delivery date is shown, the postmark thereon. If sent by regular mail, the notice shall be deemed given forty-eight (48) hours after the same is addressed as required herein and mailed with postage prepaid. Notices delivered by United States Express Mail or overnight courier that guarantees next day delivery shall be deemed given twenty-four (24) hours after delivery of the same to the United States Postal Service or courier. If any notice is transmitted by facsimile transmission or electronic mail, the same shall be deemed served or delivered on the first business day following confirmation of receipt of the transmission thereof. If notice is received after 5:00 p.m. or on a Saturday or a Sunday or a legal holiday, it shall be deemed received on the next business day.

24. Waivers. No waiver by Lessor of the Default or Breach of any term, covenant or condition hereof by Lessee, shall be deemed a waiver of any other term, covenant or condition hereof, or of any subsequent Default or Breach by Lessee of the same or any other term, covenant or condition hereof. Lessor’s consent to, or approval of, any such act shall not be deemed to render unnecessary the obtaining of Lessor’s consent to, or approval of, any subsequent or similar act by Lessee, or be construed as the basis of an estoppel to enforce the provision or provisions of this Lease requiring such consent. Regardless of Lessor’s knowledge of a Default or Breach at the time of accepting rent, the acceptance of rent by Lessor shall not be a waiver of any Default or Breach by Lessee of any provision hereof. Any payment given Lessor by Lessee may be accepted by Lessor on account of moneys or damages due Lessor, notwithstanding any qualifying statements or conditions made by Lessee in connection therewith, which such statements and/or conditions shall be of no force or effect whatsoever unless specifically agreed to in writing by Lessor at or before the time of deposit of such payment.

25. Recording. Either Lessor or Lessee shall, upon request of the other, execute, acknowledge and deliver to the other a short form memorandum of this Lease for recording purposes. The Party requesting recordation shall be responsible for payment of any fees or taxes applicable thereto.

27. Cumulative Remedies. No remedy or election hereunder shall be deemed exclusive but shall, wherever possible, be cumulative with all other remedies at law or in equity.

28. Covenants and Conditions. All provisions of this Lease to be observed or performed by Lessee are both covenants and conditions.

29. Binding Effect; Choice of Law. This Lease shall be binding upon the Parties, their personal representatives, successors and assigns and be governed by the laws of the State in which the Premises are located. Any litigation between the Parties hereto concerning this Lease shall be initiated in the county in which the Premises are located.

30. Subordination; Attornment; Non-Disturbance.

30.1 Subordination. This Lease and any Option granted hereby shall be subject and subordinate to any ground lease, mortgage, deed of trust, or other hypothecation or security device (collectively, “Security Device”), now or hereafter placed by Lessor upon the real property of which the Premises are a part, to any and all advances made on the security thereof, and to all renewals, modifications, consolidations, replacements and extensions thereof. Lessee agrees that the Lenders holding any such Security Device shall have no duty, liability or obligation to perform any of the obligations of Lessor under this Lease, but that in the event of Lessor’s default with respect to any such obligation, Lessee will give any Lender whose name and address have been furnished Lessee in writing for such purpose notice of Lessor’s default pursuant to Paragraph 13.5. If any Lender shall elect to have this Lease and/or any Option granted hereby superior to the lien of its Security Device and shall give written notice thereof to Lessee, this Lease and such Options shall be deemed prior to such Security Device, notwithstanding the relative dates of the documentation or recordation thereof.

30.2 Attornment. Subject to the non-disturbance provisions of Paragraph 30.3, Lessee agrees to attorn to a Lender or any other party who acquires ownership of the Premises by reason of a foreclosure of a Security Device, and that in the event of such foreclosure, such new owner shall not: (i) be liable for any act or omission of any prior lessor or with respect to events occurring prior to acquisition of ownership, (ii) be subject to any offsets or defenses which Lessee might have against any prior lessor, or (iii) be bound by prepayment of more than one month’s rent.

30.3 Non-Disturbance. With respect to Security Devices entered into by Lessor after the execution of this lease, Lessee’s subordination of this Lease shall be subject to receiving assurance (a “non-disturbance agreement”) from the Lender that Lessee’s possession and this Lease, including any options to extend the term hereof, will not be disturbed so long as Lessee is not in Breach hereof and attorns to the record owner of the Premises.

30.4 Self-Executing. The agreements contained in this Paragraph 30 shall be effective without the execution of any further documents; provided, however, that upon written request from Lessor or a Lender in connection with a sale, financing or refinancing of Premises, Lessee and Lessor shall execute such further writings as may be reasonably required to separately document any such subordination or non-subordination, attornment and/or non-disturbance agreement as is provided for herein.

31. Attorneys’ Fees. If any Party or Broker brings an action or proceeding to enforce the terms hereof or, declare rights hereunder, the Prevailing Party (as hereafter defined) in any such proceeding, action, or appeal thereon, shall be entitled to reasonable attorneys’ fees. Such fees may be awarded in the same suit or recovered in a separate suit, whether or not such action or proceeding is pursued to decision or judgment. The term “Prevailing Party” shall include, without limitation, a Party or Broker who substantially obtains or defeats the relief sought, as the case may be, whether by compromise, settlement, judgment, or the abandonment by the other Party or Broker of its claim or defense. The attorneys’ fee award shall not be computed in accordance with any court fee schedule, but shall be such as to fully reimburse all attorneys’ fees reasonably incurred. Lessor shall be entitled to attorneys’ fees, costs and expenses incurred in preparation and service of notices of Default and consultations in connection therewith, whether or not a legal action is subsequently commenced in connection with such Default or resulting Breach. Broker(s) shall be intended third party beneficiaries of this Paragraph 31.

 

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32. Lessor’s Access; Showing Premises; Repairs. Lessor and Lessor’s agents shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times for the purpose of showing the same to prospective purchasers, lenders, or lessees, and making such alterations, repairs, improvements or additions to the Premises or to the Building as Lessor may reasonably deem necessary. Lessor may at any time place on or about the Premises or Building any ordinary “For Sale” signs and Lessor may at any time during the last one hundred eighty (180) days of the term hereof place on or about the Premises any ordinary “For Lease” signs. All such activities of Lessor shall be without abatement of rent or liability to Lessee.

33. Auctions. Lessee shall not conduct, nor permit to be conducted, either voluntarily or involuntarily, any auction upon the Premises without first having obtained Lessor’s prior written consent. Notwithstanding anything to the contrary in this Lease, Lessor shall not be obligated to exercise any standard of reasonableness in determining whether to grant such consent.

34. Signs. Lessee shall not place any sign upon the exterior of the Premises or the Building, except that Lessee may, with Lessor’s prior written consent, install (but not on the roof) such signs as are reasonably required to advertise Lessee’s own business so long as such signs are in a location designated by Lessor and comply with Applicable Requirements and the signage criteria established for the Industrial Center by Lessor. The installation of any sign on the Premises by or for Lessee shall be subject to the provisions of Paragraph 7 (Maintenance, Repairs, Utility Installations, Trade Fixtures and Alterations). Unless otherwise expressly agreed herein, Lessor reserves all rights to the use of the roof of the Building, and the right to install advertising signs on the Building, including the roof, which do not unreasonably interfere with the conduct of Lessee’s business; Lessor shall be entitled to all revenues from such advertising signs. Notwithstanding the foregoing, Lessee shall be permitted at its sole expense to place a sign in the location as the signage occupied by the current lessee, and a monument sign near the street, subject to Lessor’s approval, which shall not be unreasonably withheld.

35. Termination; Merger. Unless specifically stated otherwise in writing by Lessor, the voluntary or other surrender of this Lease by Lessee, the mutual termination or cancellation hereof, or a termination hereof by Lessor for Breach by Lessee, shall automatically terminate any sublease or lesser estate in the Premises; provided, however, Lessor shall, in the event of any such surrender, termination or cancellation, have the option to continue any one or all of any existing subtenancies. Lessor’s failure within ten (10) days following any such event to make a written election to the contrary by written notice to the holder of any such lesser interest, shall constitute Lessor’s election to have such event constitute the termination of such interest.

36. Consents.

(a) Except for Paragraph 33 hereof (Auctions) or as otherwise provided herein, wherever in this Lease the consent of a Party is required to an act by or for the other Party, such consent shall not be unreasonably withheld or delayed. Lessor’s actual reasonable costs and expenses (including but not limited to architects’, attorneys’, engineers’ and other consultants’ fees) incurred in the consideration of, or response to, a request by Lessee for any Lessor consent pertaining to this Lease or the Premises, including but not limited to consents to an assignment a subletting or the presence or use of a Hazardous Substance, shall be paid by Lessee to Lessor upon receipt of an invoice and supporting documentation therefor. In addition to the deposit described in Paragraph 12.2(e), Lessor may, as a condition to considering any such request by Lessee, require that Lessee deposit with Lessor an amount of money (in addition to the Security Deposit held under Paragraph 5) reasonably calculated by Lessor to represent the cost Lessor will incur in considering and responding to Lessee’s request. Any unused portion of said deposit shall be refunded to Lessee without interest. Lessor’s consent to any act, assignment of this Lease or subletting of the Premises by Lessee shall not constitute an acknowledgment that no Default or Breach by Lessee of this Lease exists, nor shall such consent be deemed a waiver of any then existing Default or Breach, except as may be otherwise specifically stated in writing by Lessor at the time of such consent.

(b) All conditions to Lessor’s consent authorized by this Lease are acknowledged by Lessee as being reasonable. The failure to specify herein any particular condition to Lessor’s consent shall not preclude the impositions by Lessor at the time of consent of such further or other conditions as are then reasonable with reference to the particular matter for which consent is being given.

37. Guarantor.

37.1 Form of Guaranty. If there are to be any Guarantors of this Lease per Paragraph 1.11, the form of the guaranty to be executed by each such Guarantor shall be in the form most recently published by the American Industrial Real Estate Association, and each such Guarantor shall have the same obligations as Lessee under this lease, including but not limited to the obligation to provide the Tenancy Statement and information required in Paragraph 16.

37.2 Additional Obligations of Guarantor. It shall constitute a Default of the Lessee under this Lease if any such Guarantor fails or refuses, upon reasonable request by Lessor to give: (a) evidence of the due execution of the guaranty called for by this Lease, including the authority of the Guarantor (and of the party signing on Guarantor’s behalf) to obligate such Guarantor on said guaranty, and resolution of its board of directors authorizing the making of such guaranty, together with a certificate of incumbency showing the signatures of the persons authorized to sign on its behalf, (b) current financial statements of Guarantor as may from time to time be requested by Lessor, (c) a Tenancy Statement, or (d) written confirmation that the guaranty is still in effect.

38. Quiet Possession. Upon payment by Lessee of the rent for the Premises and the performance of all of the covenants, conditions and provisions on Lessee’s part to be observed and performed under this Lease, Lessee shall have quiet possession of the Premises for the entire term hereof subject to all of the provisions of this Lease.

39. Options.

39.1 Definition. As used in this Lease, the word Option has the following meaning: (a) the right to extend the term of this Lease or to renew this Lease or to extend or renew any lease that Lessee has on other property of Lessor; (b) the right of first refusal to lease the Premises or the right of first offer to lease the Premises or the right of first refusal to lease other property of Lessor or the right of first offer to lease other property of Lessor; (c) the right to purchase the Premises, or the right of first refusal to purchase the Premises, or the right of first offer to purchase the Premises, or the right to purchase other property of Lessor, or the right of first refusal to purchase other property of Lessor, or the right of first offer to purchase other property of Lessor.

39.2 Options Personal to Original Lessee. Each Option granted to Lessee in this Lease is personal to the original Lessee named in Paragraph 1.1 hereof, and cannot be voluntarily or involuntarily assigned or exercised by any person or entity other than said original Lessee while the original Lessee is in full and actual possession of the Premises and without the intention of thereafter assigning or subletting. The Options, if any, herein granted !o Lessee are not assignable, either as a part of an assignment of this Lease or separately or apart therefrom, and no Option may be separated from this Lease in any manner, by reservation or otherwise.

39.3 Multiple Options. In the event that Lessee has any multiple Options to extend or renew this Lease, a later option cannot be exercised unless the prior Options to extend or renew this Lease have been validly exercised.

39.4 Effect of Default on Options.

(a) Lessee shall have no right to exercise an Option, notwithstanding any provision in the grant of Option to the contrary: (i) during the period commencing with the giving of any notice of Default under Paragraph 13.1 and continuing until the noticed Default is cured, or (ii) during the period of time any monetary obligation due Lessor from Lessee is unpaid (without regard to whether notice thereof is given Lessee), or (iii) during the time Lessee is in Breach of this Lease, or (iv) in the event that Lessor has given to Lessee three (3) or more notices of separate Defaults under Paragraph 13.1 during the twelve (12) month period immediately preceding the exercise of the Option, whether or not the Defaults are cured.

 

© American Industrial Real Estate Association 1993

MULTI-TENANT - GROSS

14


(b) The period of time within which an Option may be exercised shall not be extended or enlarged by reason of Lessee’s inability to exercise an Option because of the provisions of Paragraph 39.4(a)

(c) All rights of Lessee under the provisions of an Option shall terminate and be of no further force or effect, notwithstanding Lessee’s due and timely exercise of the Option, if, after such exercise and during the term of this Lease, (i) Lessee fails to pay to Lessor a monetary obligation of Lessee for a period of thirty (30) days after such obligation becomes due (without any necessity of Lessor to give notice thereof to Lessee), or (ii) Lessor gives to Lessee three (3) or more notices of separate Defaults under Paragraph 13.1 during any twelve (12) month period, whether or not the Defaults are cured, or (iii) if Lessee commits a Breach of this Lease.

40. Rules and Regulations. Lessee agrees that it will abide by, and keep and observe all reasonable rules and regulations (“Rules and Regulations”) which Lessor may make from time to time for the management, safety, care, and cleanliness of the grounds, the parking and unloading of vehicles and the preservation of good order, as well as for the convenience of other occupants or tenants of the Building and the Industrial Center and their invitees.

41. Security Measures. Lessee hereby acknowledges that the rental payable to Lessor hereunder does not include the cost of guard service or other security measures, and that Lessor shall have no obligation whatsoever to provide same. Lessee assumes ail responsibility for the protection of the Premises, Lessee, its agents and invitees and their property from the acts of third parties.

42. Reservations. Lessor reserves the right, from time to time, to grant, without the consent or joinder of Lessee, such easements, rights of way, utility raceways, and dedications that Lessor deems necessary, and to cause the recordation of parcel maps and restrictions, so long as such easements, rights of way, utility raceways, dedications, maps and restrictions do not reasonably interfere with the use of the Premises by Lessee. Lessee agrees to sign any documents reasonably requested by Lessor to effectuate any such easement rights, dedications, map or restrictions.

43. Performance Under Protest. If at any time a dispute shelf arise as to any amount or sum of money to be paid by one Party to the other under the provisions hereof, the Party against whom the obligation to pay the money is asserted shall have the right to make payment “under protest” and such payment shall not be regarded as a voluntary payment and there shall survive the right on the part of said Party to institute suit for recovery of such sum. If it shall be adjudged that there was no legal obligation on the part of said Party to pay such sum or any part thereof, said Party shall be entitled to recover such sum or so much thereof as it was not legally required to pay under the provisions of this Lease.

44. Authority. If either Party hereto is a corporation, trust, or general or limited partnership, each individual executing this Lease on behalf of such entity represents and warrants that he or she is duly authorized to execute and deliver this Lease on its behalf. If Lessee is a corporation, trust or partnership, Lessee shall, within thirty (30) days after request by Lessor, deliver to Lessor evidence satisfactory to Lessor of such authority.

45. Conflict. Any conflict between the printed provisions of this Lease and the typewritten or handwritten provisions shall be controlled by the typewritten or handwritten provisions.

46. Offer. Preparation of this Lease by either Lessor or Lessee or Lessor’s agent or Lessee’s agent and submission of same to Lessee or Lessor shall not be deemed an offer to lease. This Lease is not intended to be binding until executed and delivered by all Parties hereto.

47. Amendments. This Lease may be modified only in writing, signed by the parties in interest at the time of the modification. The Parties shall amend this Lease from time to time to reflect any adjustments that are made to the Base Rent or other rent payable under this Lease. As long as they do not materially change Lessee’s obligations hereunder, Lessee agrees to make such reasonable non-monetary modifications to this Lease as may be reasonably required by an institutional insurance company or pension plan Lender in connection with the obtaining of normal financing or refinancing of the property of which the Premises are a part.

48. Multiple Parties. Except as otherwise expressly provided herein, if more than one person or entity is named herein as either Lessor or Lessee, the obligations of such multiple parties shall be the joint and several responsibility of all persons or entities named herein as such Lessor or Lessee.

49. In the case that Parker the current tenant vacates the property after March 1, 2018 but earlier than September 30, 2018 , then Avita to start paying the rent at a rate of $24,192.00 per month or portion thereof.

50. The building has major improvements and additional equipment on the roof by the current Tenant and Avita is taking the units as is and is responsible for their upkeep, subject to the provisions of Sections 7.1 and 7.2 above.

51. SEE RENT ADJUSTMENT(S), WHICH IS INCORPORATED HEREIN BY THIS REFERENCE AND MADE A PART HEREOF.

52. SEE OPTION(S) TO EXTEND, STANDARD LEASE ADDENDUM, WHICH IS INCORPORATED HEREIN BY THIS REFERENCE AND MADE A PART HEREOF.

53. Notwithstanding anything to the contrary herein, the Lessor will be responsible for its own trash collection and trash disposal. In this regard, the cost of trash disposal shall not be included in the Common Area Operating Expenses Lessee is required to pay pursuant to paragraph 4.2(a)(iii) above.

 

 

© American Industrial Real Estate Association 1993

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LESSOR AND LESSEE HAVE CAREFULLY READ AND REVIEWED THIS LEASE AND EACH TERM AND PROVISION CONTAINED HEREIN, AND BY THE EXECUTION OF THIS LEASE SHOW THEIR INFORMED AND VOLUNTARY CONSENT THERETO. THE PARTIES HEREBY AGREE THAT, AT THE TIME THIS LEASE IS EXECUTED, THE TERMS OF THIS LEASE ARE COMMERCIALLY REASONABLE AND EFFECTUATE THE INTENT AND PURPOSE OF LESSOR AND LESSEE WITH RESPECT TO THE PREMISES.

IF THIS LEASE HAS BEEN FILLED IN, IT HAS BEEN PREPARED FOR YOUR ATTORNEY’S REVIEW AND APPROVAL. FURTHER, EXPERTS SHOULD BE CONSULTED TO EVALUATE THE CONDITION OF THE PROPERTY FOR THE POSSIBLE PRESENCE OF ASBESTOS, UNDERGROUND STORAGE TANKS OR HAZARDOUS SUBSTANCES. NO REPRESENTATION OR RECOMMENDATION IS MADE BY THE AMERICAN INDUSTRIAL REAL ESTATE ASSOCIATION OR BY THE REAL ESTATE BROKERS OR THEIR CONTRACTORS, AGENTS OR EMPLOYEES AS TO THE LEGAL SUFFICIENCY, LEGAL EFFECT, OR TAX CONSEQUENCES OF THIS LEASE OR THE TRANSACTION TO WHICH IT RELATES; THE PARTIES SHALL RELY SOLELY UPON THE ADVICE OF THEIR OWN COUNSEL AS TO THE LEGAL AND TAX CONSEQUENCES OF THIS LEASE. IF THE SUBJECT PROPERTY IS IN A STATE OTHER THAN CALIFORNIA, AN ATTORNEY FROM THE STATE WHERE THE PROPERTY IS LOCATED SHOULD BE CONSULTED.

The parties hereto have executed this Lease at the place and on the dates specked above their respective signatures.

 

Executed at::   VENTURA, CA.     Executed at::   Valencia, CA
On:   January 25, 2018     On:   January 31, 2018
By LESSOR:       By LESSEE:  
  HARTCO-VENTURA INC.       Avita Medical Americas, LLC
               
               
By:  

/s/ JOHN SALEH

    By:  

/s/ TIMOTHY ROONEY

Name Printed:   JOHN SALEH     Name Printed:   TIMOTHY ROONEY
Title:   PRESIDENT     Title:   CAO
By:  

 

    By:  

 

Name Printed:  

 

    Name Printed:  

 

Title:  

 

    Title:  

 

Address:  

 

    Address:  

 

 

 

     

 

Telephone: (    )  

 

    Telephone: (    )  

 

Facsimile: (    )  

 

    Facsimile: (    )  

 

 

© American Industrial Real Estate Association 1993

MULTI-TENANT - GROSS

16


RENT ADJUSTMENT(S)

ADDENDUM TO

STANDARD LEASE

 

Dated    January 25, 2018   
By and Between (Lessor)    Hartco-Ventura Inc.   
(Lessee)    Avita Medical Americas   
Property Address:    3007 Bunsen Ave., Units I,J,K,L,M,N   

Paragraph 51

 

A.

RENT ADJUSTMENTS:

The monthly rent for each month of the adjustment period(s) specified below shall be increased using the method(s) indicated below:

(Check Method(s) to be Used and Fill in Appropriately)

 

I.          Cost of Living Adjustment(s) (COL)

 

  (a)

On (Fill in COL Adjustment Date(s):                                                                                                                                                                       

 

 

the monthly rent payable under paragraph 1.5 (“Base Rent”) of the attached Lease shall be adjusted by the change, if any, from the Base Month specified below, in the Consumer Price Index of the Bureau of Labor Statistics of the U.S. Department of Labor for (select one): p CPI W (Urban Wage Earners and Clerical Workers) or p CPI U (All Urban Consumers), for (Fill in Urban Area):

                                                                                                                                                                                                                                     , All Items (1982-1984 = 100), herein referred to as “C.P.I.”

(b) The monthly rent payable in accordance with paragraph Alfa) of this Addendum shall be calculated as follows: the Base Rent set forth in paragraph 1.5 of the attached Lease, shall be multiplied by a fraction the numerator of which shall be the C.P I. of the calendar month 2 (two) months prior to the month(s) specified in paragraph AI(a) above during which the adjustment is to take effect, and the denominator of which shall be the C.P I. of the calendar month which is two (2) months prior to (select one): p the first month of the term of this Lease as set forth in paragraph 1.3 (“Base Month”) or D (Fill in Other “Base Month”):

The sum so calculated shall constitute the new monthly rent hereunder, but in no event, shall any such new monthly rent be less than the rent payable for the month immediately preceding the date for rent adjustment.

(c) In the event the compilation and/or publication of the C.P.I. shall be transferred to any other governmental department or bureau or agency or shall be discontinued, then the index most nearly the same as the CP. I. shall be used to make such calculation. In the event that Lessor and Lessee cannot agree on such alternative index, then the matter shall be submitted for decision to the American Arbitration Association in accordance with the then rules of said association and the decision of the arbitrators shall be binding upon the parties. The cost of said Arbitrators shall be paid equally by Lessor and Lessee.

 

    

II.         Market Rental Value Adjustment(s) (MRV)

 

  (a)

On (Fill in MRV Adjustment Date(s):                                                                                                                                                                     

 

 

the monthly rent payable under paragraph 1.5 (“Base Rent”) of the attached Lease shall be adjusted to the “Market Rental Value” of the property as follows:

1) Four months prior to the Market Rental Value (MRV) Adjustment Date(s) described above, Lessor and Lessee shall meet to establish an agreed upon new MRV for the specified term. If agreement cannot be reached, then:

i) Lessor and Lessee shall immediately appoint a mutually acceptable appraiser or broker to establish the new MRV within the next 30 days. Any associated costs will be split equally between the parties, or

ii) Both Lessor and Lessee shall each immediately select and pay the appraiser or broker of their choice to establish a MRV within the next 30 days. If, for any reason, either one of the appraisals is not completed within the next 30 days, as stipulated, then the appraisal that is completed at that time shall automatically become the new MRV If both appraisals are completed and the two appraisers/brokers cannot agree on a reasonable average MRV then they shall immediately select a third mutually acceptable appraiser/broker to establish a third MRV within the next 30 days. The average of the two appraisals closest in value shall then become the new MRV The costs of the third appraisal will be split equally between the parties.

 

RENT ADJUSTMENT(S)

Page 1 of 2


2) In any event, the new MRV shall not be less than the rent payable for the month immediately preceding the date for rent adjustment.

 

  (b)

Upon the establishment of each New Market Rental Value as described in paragraph All:

1) the monthly rental sum so calculated for each term as specified in paragraph All(a) will become the new “Base Rent” for the purpose of calculating any further Cost of Living Adjustments as specified in paragraph Alfa) above and

2) the first month of each Market Rental Value term as specified in paragraph All(a) shall become the new “Base Month” for the purpose of calculating any further Cost of Living Adjustments as specified in paragraph AI(b).

 

☒☒

III.        Fixed Rental Adjustment(s) (FRA)

The monthly rent payable under paragraph 1.5 (“Base Rent”) of the attached Lease shall be increased to the following amounts on the dates set forth below:

 

    On (Fill in FRA Adjustment Date(s)):        The New Base Rental shall be:
  October 1, 2019   $    $24,883.20
  October 1, 2020   $    $25,574.40
      $     
      $     

B. NOTICE: Unless specified otherwise herein, notice of any escalations other than Fixed Rental Adjustment(s) shall be made as specified in paragraph 23 of the attached Lease.

C. BROKER’S FEE: N/A

The Real Estate Brokers specified in paragraph 1.10 of the attached Lease shall be paid a Brokerage Fee for each adjustment specified above in accordance with paragraph 15 of the attached Lease.

 

RENT ADJUSTMENT(S)

Page 2 of 2


LOGO

OPTION(S) TO EXTEND

STANDARD LEASE ADDENDUM

 

  Dated January 25, 2018
  By and Between (Lessor) Hartco Ventura, Inc.
  By and Between (Lessee) Avita Medical Americas, LLC, a Delaware limited liability company
  Address of Premises: 3007 Bunsen Avenue, Units I, J, K, L, M, N Ventura, California 93003

Paragraph 52

 

A.

OPTION(S) TO EXTEND:

Lessor hereby grants to Lessee the option to extend the term of this Lease for three additional three-year month period(s) commencing when the prior term expires upon each and all of the following terms and conditions:

(i) In order to exercise an option to extend, Lessee must give written notice of such election to Lessor and Lessor must receive the same at least 9 but not more than 12 months prior to the date that the option period would commence, time being of the essence. If proper notification of the exercise of an option is not given and/or received, such option shall automatically expire. Options (if there are more than one) may only be exercised consecutively.

(ii) The provisions of paragraph 39, including those relating to Lessee’s Default set forth in paragraph 39.4 of this Lease, are conditions of this Option.

(iii) Except for the provisions of this Lease granting an option or options to extend the term, all of the terms and conditions of this Lease except where specifically modified by this option shall apply.

(iv) This Option is personal to the original Lessee, and cannot be assigned or exercised by anyone other than said original Lessee and only while the original Lessee is in full possession of the Premises and without the intention of thereafter assigning or subletting. This option may be exercised by (A) the original Lessee, (B) any assignee or sublessee approved by the Lessor under the terms of Article 12, or (C) any assignee or sublessee exempted from the requirement of Lessor consent pursuant to paragraph 12.1(f).

(v) The monthly rent for each month of the option period shall be calculated as follows, using the method(s) indicated below:

(Check Method(s) to be Used and Fill in Appropriately)

 

I.    Cost of Living Adjustment(s) (COLA)

 

          

a.   On (Fill in COLA Dates):                                                                                                                                                                                                

 

 

the Base Rent shall be adjusted by the change, if any, from the Base Month specified below, in the Consumer Price Index of the Bureau of Labor Statistics of the U.S. Department of Labor for (select one): ☐ CPI W (Urban Wage Earners and Clerical Workers) or ☐ CPI U (All Urban Consumers), for (Fill in Urban Area):

 

 

All Items (1982-1984 = 100), herein referred to as “CPI”.

 

© 2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION

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b. The monthly Base Rent payable in accordance with paragraph A.I.a. of this Addendum shall be calculated as follows: the Base Rent set forth in paragraph 1.5 of the attached Lease, shall be multiplied by a fraction the numerator of which shall be the CPI of the calendar month 2 months prior to the month(s) specified in paragraph A.I.a. above during which the adjustment is to take effect, and the denominator of which shall be the CPI of the calendar month which is 2 months prior to (select one): ☐ the first month of the term of this Lease as set forth in paragraph 1.3 (“Base Month”) or ☐ (Fill in Other “Base Month”):

 

 

The sum so calculated shall constitute the new monthly Base Rent hereunder, but in no event, shall any such new monthly Base Rent be less than the Base Rent payable for the month immediately preceding the rent adjustment.

c. In the event the compilation and/or publication of the CPI shall be transferred to any other governmental department or bureau or agency or shall be discontinued, then the index most nearly the same as the CPI shall be used to make such calculation. In the event that the Parties cannot agree on such alternative index, then the matter shall be submitted for decision to the American Arbitration Association in accordance with the then rules of said Association and the decision of the arbitrators shall be binding upon the parties. The cost of said Arbitration shall be paid equally by the Parties.

 

II.    Market Rental Value Adjustment(s) (MRV)

 

        

  a.      On (Fill in MRV Adjustment Date (s))                                                                                                                                                                            

 

 

the Base Rent shall be adjusted to the “Market Rental Value” of the property as follows:

1) Four months prior to each Market Rental Value Adjustment Date described above, the Parties shall attempt to agree upon what the new MRV will be on the adjustment date. If agreement cannot be reached, within thirty days, then:

(a) Lessor and Lessee shall immediately appoint a mutually acceptable appraiser or broker to establish the new MRV within the next 30 days. Any associated costs will be split equally between the Parties, or

(b) Both Lessor and Lessee shall each immediately make a reasonable determination of the MRV and submit such determination, in writing, to arbitration in accordance with the following provisions:

(i) Within 15 days thereafter, Lessor and Lessee shall each select an independent third party ☐ appraiser or ☐ broker (“Consultant” - check one) of their choice to act as an arbitrator (Note: the parties may not select either of the Brokers that was involved in negotiating the Lease). The two arbitrators so appointed shall immediately select a third mutually acceptable Consultant to act as a third arbitrator.

(ii) The 3 arbitrators shall within 30 days of the appointment of the third arbitrator reach a decision as to what the actual MRV for the Premises is, and whether Lessor’s or Lessee’s submitted MRV is the closest thereto. The decision of a majority of the arbitrators shall be binding on the Parties. The submitted MRV which is determined to be the closest to the actual MRV shall thereafter be used by the Parties.

(iii) If either of the Parties fails to appoint an arbitrator within the specified 15 days, the arbitrator timely appointed by one of them shall reach a decision on his or her own, and said decision shall be binding on the Parties.

(iv) The entire cost of such arbitration shall be paid by the party whose submitted MRV is not selected, ie. the one that is NOT the closest to the actual MRV.

2) When determining MRV, the Lessor, Lessee and Consultants shall consider the terms of comparable market transactions which shall include, but not limited to, rent, rental adjustments, abated rent, lease term and financial condition of tenants.

3) Notwithstanding the foregoing, the new Base Rent shall not be less than the rent payable for the month immediately preceding the rent adjustment.

 

        b.

    Upon the establishment of each New Market Rental Value:

1) the new MRV will become the new “Base Rent” for the purpose of calculating any further Adjustments, and

2) the first month of each Market Rental Value term shall become the new “Base Month” for the purpose of calculating any further Adjustments.

 

III.     Fixed Rental Adjustment(s) (FRA)

The Base Rent shall be increased to the following amounts on the dates set forth below:

 

On (Fill in FRA Adjustment Date(s)):       The New Base Rent shall be:
October 1, 2021      

$26,496.00

October 1, 2022      

$27,417.60

October 1, 2023      

$28,839.20

October 1, 2024      

$29,260.80

October 1, 2025      

$30,182.40

October 1, 2026      

$31,104.00

October 1, 2027      

$32,025.60

October 1, 2028      

$33,062.40

October 1, 2029      

$34,099.20

 

     

 

 

© 2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION

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    IV.

    Initial Term Adjustments.

The formula used to calculate adjustments to the Base Rate during the original Term of the Lease shall continue to be used during the extended term.

 

B.

NOTICE:

Unless specified otherwise herein, notice of any rental adjustments, other than Fixed Rental Adjustments, shall be made as specified in paragraph 23 of the Lease.

 

C.

BROKER’S FEE:

The Brokers shall be paid a Brokerage Fee for each adjustment specified above in accordance with paragraph 15 of the Lease or if applicable, paragraph 9 of the Sublease.

NOTICE: These forms are often modified to meet changing requirements of law and industry needs. Always write or call to make sure you are utilizing the most current form: AIR Commercial Real Estate Association, 500 N Brand Blvd, Suite 900, Glendale, CA 91203.

Telephone No. (213) 687-8777. Fax No.: (213) 687-8616.

 

© 2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION

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   PAGE 3 OF 3   
EX-4.9

Exhibit 4.9

 

LOGO

STANDARD MULTI-TENANT OFFICE LEASE - GROSS

AIR COMMERCIAL REAL ESTATE ASSOCIATION

 

1.

Basic Provisions (“Basic Provisions”).

1.1 Parties: This Lease (“Lease”), dated for reference purposes only October 3, 2016 is made by and between RIF III – Avenue Stanford, LLC, a California limited liability company (“Lessor”) and Avita Medical Americas, LLC, a Delaware limited liability company (“Lessee”), (collectively the “Parties”, or individually a “Party”).

1.2(a) Premises: That certain portion of the Project (as defined below), known as Suite Numbers(s) 220, 2nd floor(s), consisting of approximately 11,825 rentable square feet (subject to remeasurement) and approximately _ useable square foot (“Premises”). The Premises are located at: 28159 Avenue Stanford, in the City of Valencia, County of Los Angeles, State of California, with zip code 91355. In addition to Lessee’s rights to use and occupy the Premises as hereinafter specified, Lessee shall have non-exclusive rights to the Common Areas (as defined in Paragraph 2.7 below) as hereinafter specified, but shall not have any rights to the roof, the exterior walls, the area above the dropped ceilings, or the utility raceways of the building containing the Premises (“Building”) or to any other buildings in the Project. The Premises, the Building, the Common Areas, the land upon which they are located, along with all other buildings and improvements thereon, are herein collectively referred to as the “Project.” The Project consists of approximately 78,910 rentable square feet. (See also Paragraph 2)

1.2(b) Parking: Forty-Six (46) unreserved vehicle parking spaces at no additional expense for the term of the Lease and 0 reserved vehicle parking spaces at a monthly cost of $0.00 per unreserved space and $0.00 per reserved space. (See Paragraph 2.6)

1.3 Term: Four (4) years and One (1) months (“Original Term”) commencing December 1, 2016 (“Commencement Date”) and ending December 31, 2020 (“Expiration Date”). (See also Paragraph 3)

1.4 Early Possession: If the Premises are available Lessee may have non-exclusive possession of the Premises commencing Upon Lease execution; payment of total monies due; receipt of Certificate of Insurance and endorsement pursuant to Paragraph 8.2 herein, so long as Lessee does not interfere with the Lessor Improvements (“Early Possession Date”). (See also Paragraphs 3.2 and 3.3)

1.5 Base Rent: $19,511.25 per month (“Base Rent”), payable on the first (1st) day of each month commencing December 1, 2016. (See also Paragraph 4)

☑ If this box is checked, there are provisions in this Lease for the Base Rent to be adjusted. See Paragraph 50

1.6 Lessee’s Share of Operating Expense Increase: Fourteen and Ninety-Nine Hundredths percent (14.99%) (“Lessee’s Share”). In the event that that size of the Premises and/or the Project are modified during the term of this Lease, Lessor shall recalculate Lessee’s Share to reflect such modification. Notwithstanding anything herein to the contrary, Lessee shall only be required to pay any increases in Operating Expenses, Insurance Premiums and Real Property Taxes over the Base Year.

1.7 Base Rent and Other Monies Paid Upon Execution:

(a) Base Rent: $19,511.25 for the period Dec. 1, 2016 – Dec. 31, 2016.

(b) Security Deposit: $63,961.41 (“Security Deposit”). (See also Paragraph 5)

(c) Parking: $0.00 for the period N/A.

(d) Other: $0.00 for N/A.

(e) Total Due Upon Execution of this Lease: $83,472.66.

1.8 Agreed Use: Administrative and professional office and storage of trade supplies and/or components in accordance with standard medical/pharmaceutical industry standards. (See also Paragraph 6)

1.9 Base Year; Insuring Party. The Base Year is 2016. Lessor is the “Insuring Party”. (See also Paragraphs 4.2 and 8)

1.10 Real Estate Brokers: (See also Paragraph 15 and 25)

(a) Representation: The following real estate brokers (the “Brokers”) and brokerage relationships exist in this transaction (check applicable boxes):

                                                                                 represents Lesser exclusively (“Lesser’s Broker”);

                                                                                             represents Lessee exclusively (“Lessee’s Broker”); or

☑ CBRE, Inc. represents both Lessor and Lessee (“Dual Agency”).

(b) Payment to Brokers: Upon execution and delivery of this Lease by both Parties, Lessor shall pay to the Brokers for the brokerage services rendered by the Brokers the fee agreed to in the attached a separate written agreement or if no such agreement is attached, the sum of                      or                 % of the total Base Rent payable for the Original Term, the sum of                 or                  of the total Base Rent payable during any period of time that the Lessee occupies the Premises subsequent to the Original Term, and/or the sum of                  or                 % of the purchase price in the event that the Lessee or anyone affiliated with Lessee acquires from Lesser any rights to the Premises.

 

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1.11 Guarantor. The obligations of the Lessee under this Lease shall be guaranteed by N/A (“Guarantor”). (See also Paragraph 37)

1.12 Business Hours for the Building: 8:00 a.m. to 6:00 p.m., Mondays through Fridays (except Building Holidays) and 9:00 a.m. to 1:00 p.m. on Saturdays and Sunday (except Building Holidays). “Building Holidays” shall mean the dates of observation of New Year’s Day, President’s Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day, Christmas Day, and any other recognized national or state. Lessor shall provide heating, ventilating and air conditioning systems (“HVAC”) during Business Hours. Lessor acknowledges, during the initial term only, Lessee shall control the thermostat servicing the Premises.

1.13 Lessor Supplied Services. Notwithstanding the provisions of Paragraph 11.1, Lessor is NOT obligated to provide the following within the Premises:

☑ Janitorial services

☐ Electricity

☐ Other (specify):                                                                                       

1.14 Attachments. Attached hereto are the following, all of which constitute a part of this Lease:

☑ an Addendum consisting of Paragraphs 1.2, 2.2, 2.2 (a), 2.4, 2.6, 2.9, 6.1, 7.3 (d), 7.4 (b), 7.4 (c), 11, 12.2 (h), 23.1, 34 and 48 through 57;

☑ a plot plan depicting the Premises—Exhibit “A”;

☐ a current set of the Rules and Regulations;

☐ a Work Letter;

☐ a janitorial schedule;

other (specify): Tenant Move–In/Move–Out Checklist; Tenant Contact Information Sheet; Exhibit “B” – Lessor Improvements; Exhibit “C” – Acknowledgement of Premises.

2. Premises.

2.1 Letting. Lessor hereby leases to Lessee, and Lessee hereby leases from Lessor, the Premises, for the term, at the rental, and upon all of the terms, covenants and conditions set forth in this Lease. While the approximate square footage of the Premises may have been used in the marketing of the Premises for purposes of comparison, the Base Rent stated herein is NOT tied to square footage and is not subject to adjustment should the actual size be determined to be different.   Note: Lessee is advised to verify the actual size prior to executing this Lease.

2.2 Condition. Lessor shall deliver the Premises to Lessee in a clean condition on the Commencement Date or the Early Possession Date, whichever first occurs (“Start Date”), and warrants that the existing electrical, plumbing, fire sprinkler, lighting, heating, ventilating and air conditioning systems (“HVAC”), and all other items which the Lessor is obligated to construct pursuant to the Work Letter attached hereto, if any, other than those constructed by Lessee, shall be in good operating condition on said date, that the structural elements of the roof, bearing walls and foundation of the Unit shall be free of material defects, and that the Premises do not contain hazardous levels of any mold or fungi defined as toxic under applicable state or federal law.

2.3 Compliance. Lessor does not warrants to the best of its knowledge that the improvements comprising the Premises and the Common Areas comply with the building codes that were in effect at the time that each such improvement, or portion thereof, was constructed, and also or that they will comply with all applicable laws, covenants or restrictions of record, regulations, and ordinances (“Applicable Requirements”) in effect on the later date of either the Commencement Date or substantial completion of Lessor Improvements Start Date. Said warranty does not apply to the use to which Lessee will put the premises, modifications which may be required by the Americans with Disabilities Act or any similar laws as a result of Lessee’s use (see Paragraph 49), or to any Alterations or Utility Installations (as defined in Paragraph 7.3(a)) made or to be made by Lessee. NOTE: Lessee is responsible for determining whether or not the zoning and other Applicable Requirements are appropriate for Lessee’s intended use, and acknowledges that past uses of the Premises may no longer be allowed. If However, if improvements that are located on the Common Areas and the Premises do not comply with Applicable Requirements that are in effect and enforced against the Premises and Common Areas as of the date of this Lease said warranty, Lessor shall, except as otherwise provided, promptly after receipt of written notice from Lessee setting forth with specificity the nature and extent of such non-compliance, rectify the same. If Lessee does not give Lessor written notice of the failure of the Premises and the Common Areas to comply with Applicable Requirements (that are in effect and enforced against the Premises and the Common Areas as of the date of htis Lease) within six (6) months following the later date of either the Commencement Date or substantial completion of Lessor Improvements (which notice must describe the non-compliance with specificity and be accompanied by any notices Lessee has received with respect thereto) then correction of that non-compliance shall be the obligtation of Lessee at Lessee’s sole cost and expense. If the Applicable Requirements are hereafter changed so as to require during the term of this Lease the construction of an addition to or an alteration of the Premises, the remediation of any Hazardous Substance, or the reinforcement or other physical modification of the Premises (“Capital Expenditure”), Lessor and Lessee shall allocate the cost of such work as follows:

(a) Subject to Paragraph 2.3(c) below, if such Capital Expenditures are required as a result of the specific and unique use of the Premises by Lessee as compared with uses by tenants in general, Lessee shall be fully responsible for the cost thereof, provided, however that if such Capital Expenditure is required during the last 2 years of this Lease and the cost thereof exceeds 6 months’ Base Rent, Lessee may instead terminate this Lease unless Lesser notifies Lessee, in writing, within 10 days after receipt of Lessee’s termination notice that Lesser has elected to pay the difference between the actual cost there of and the amount equal to 6 months’ Base Rent. If Lessee elects termination, Lessee shall immediately cease the use of the Premises which requires such Capital Expenditure and deliver to Lesser written notice specifying a termination date at least 90 days thereafter. Such termination date shall, however, in no event be earlier than the last day that Lessee could legally utilize the Premises without commencing such Capital Expenditure.

(b) If such Capital Expenditure is not the result of the specific and unique use of the Premises by Lessee (such as, governmentally mandated seismic modifications), then Lessor shall pay for such Capital Expenditure and Lessee shall only be obligated to pay, each month during the remainder of the term of this Lease or any extension thereof, on the date that on which the Base Rent is due, an amount equal to 1/144th of the portion of such costs reasonably attributable to the Premises. Lessee shall pay Interest on the balance but may prepay its obligation at any time. If, however, such Capital Expenditure is required during the last 2 years of this Lease or if Lessor reasonably determines that it is not economically feasible to pay its share thereof, Lessor shall have the option to terminate this Lease upon 90 days prior written notice to Lessee unless Lessee notifies Lessor, in writing, within 10 days after receipt of Lessor’s termination notice that Lessee will pay for the entire cost of such Capital Expenditure in immediately available funds. If Lessor does not elect to terminate, and fails to tender its share of any such Capital Expenditure, Lessee may advance such funds and deduct same, with Interest, from Rent until Lessor’s share of such costs have been fully paid. If Lessee is unable to finance Lessor’s share, or if the balance of the Rent due and payable for the remainder of this Lease is not sufficient to fully reimburse Lessee on an offset basis, Lessee shall have the right to terminate this Lease upon 30 days written notice to Lessor.

(c) Notwithstanding the above, the provisions concerning Capital Expenditures are intended to apply only to nonvoluntary, unexpected, and new Applicable Requirements. If the Capital Expenditures are instead triggered by Lessee as a result of an actual or proposed change in use, change in intensity of use, or modification to the Premises then, and in that event, Lessee shall either: (i) immediately cease such changed use or intensity of use and/or take such other steps as may be necessary to eliminate the requirement for such Capital Expenditure, or (ii) complete such Capital Expenditure at its own expense. Lessee shall not have any right to terminate this Lease.

2.4 Acknowledgements. Lessee acknowledges that: (a) it has been given an opportunity to inspect and measure the Premises, (b) Lessee has been advised by Lessor and/or Brokers to satisfy itself with respect to the size and condition of the Premises (including but not limited to the electrical, HVAC and fire sprinkler systems, security, environmental aspects, and compliance with Applicable Requirements), and their suitability for Lessee’s intended use, (c) Lessee has made such investigation as it deems necessary with reference to such matters and assumes all responsibility therefor as the same relate to its occupancy of the Premises, (d) it is not relying on any representation as to the size of the Premises made by Brokers or Lessor, (e) the square footage of the Premises was not material to Lessee’s decision to lease the Premises and pay the Rent stated herein, and (f)

 

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neither Lessor, Lessor’s agents, nor Brokers have made any oral or written representations or warranties with respect to said matters other than as set forth in this Lease. In addition, Lesser acknowledges that: (i) Brokers have made no representations, premises or warranties concerning Lessee’s ability to honor the Lease or suitability to occupy the Premises, and (ii) it is Lesser’s solo responsibility to investigate the financial capability and/or suitability of all proposed tenants.

2.5 Lessee as Prior Owner/Occupant. The warranties made by Lessor in Paragraph 2 shall be of no force or effect if immediately prior to the Start Date, Lessee was the owner or occupant of the Premises. In such event, Lessee shall be responsible for any necessary corrective work.

2.6 Vehicle Parking. So long as Lessee is not in default, and subject to the Rules and Regulations attached hereto, and as established by Lessor from time to time, Lessee shall be entitled to rent and use the number of parking spaces specified in Paragraph 1.2(b) at the rental rate applicable from time to time for monthly parking as set by Lessor and/or its licensee.

(a) If Lessee commits, permits or allows any of the prohibited activities described in the Lease or the rules then in effect, then Lessor shall have the right, without notice, in addition to such other rights and remedies that it may have, to remove or tow away the vehicle involved and charge the cost to Lessee, which cost shall be immediately payable upon demand by Lessor.

(b) The monthly rent per parking space specified in Paragraph 1.2(b) is subject to change upon 30 days prior written notice to Lessee. The rent for the parking is payable one month in advance prior to the first day of each calendar month.

2.7 Common Areas—Definition. The term “Common Areas” is defined as all areas and facilities outside the Premises and within the exterior boundary line of the Project and interior utility raceways and installations within the Premises that are provided and designated by the Lessor from time to time for the general nonexclusive use of Lessor, Lessee and other tenants of the Project and their respective employees, suppliers, shippers, customers, contractors and invitees, including, but not limited to, common entrances, lobbies, corridors, stairwells, public restrooms, elevators, parking areas, loading and unloading areas, trash areas, roadways, walkways, driveways and landscaped areas.

2.8 Common Areas—Lessee’s Rights. Lessor grants to Lessee, for the benefit of Lessee and its employees, suppliers, shippers, contractors, customers and invitees, during the term of this Lease, the nonexclusive right to use, in common with others entitled to such use, the Common Areas as they exist from time to time, subject to any rights, powers, and privileges reserved by Lessor under the terms hereof or under the terms of any rules and regulations or restrictions governing the use of the Project. Under no circumstances shall the right herein granted to use the Common Areas be deemed to include the right to store any property (including without limitation, pallets), temporarily or permanently, in the Common Areas. Any such storage shall be permitted only by the prior written consent of Lessor or Lessor’s designated agent, which consent may be revoked at any time. In the event that any unauthorized storage shall occur then Lessor shall have the right, without notice, in addition to such other rights and remedies that it may have, to remove the property and charge the cost to Lessee, which cost shall be immediately payable upon demand by Lessor.

2.9 Common Areas—Rules and Regulations. Lessor or such other person(s) as Lessor may appoint shall have the exclusive control and management of the Common Areas and shall have the right, from time to time, to adopt, modify, amend and enforce reasonable rules and regulations (“Rules and Regulations”) for the management, safety, care, and cleanliness of the grounds, the parking and unloading of vehicles and the preservation of good order, as well as for the convenience of other occupants or tenants of the Building and the Project and their invitees. The Lessee agrees to abide by and conform to all such Rules and Regulations, and shall use its best efforts to cause its employees, suppliers, shippers, customers, contractors and invitees to so abide and conform. Lessor shall not be responsible to Lessee for the noncompliance with said Rules and Regulations by other tenants of the Project.

2.10 Common Areas—Changes. Lessor shall have the right, in Lessor’s sole discretion, from time to time:

(a) To make changes to the Common Areas, including, without limitation, changes in the location, size, shape and number of the lobbies, windows, stairways, air shafts, elevators, escalators, restrooms, driveways, entrances, parking spaces, parking areas, loading and unloading areas, ingress, egress, direction of traffic, landscaped areas, walkways and utility raceways;

(b) To close temporarily any of the Common Areas for maintenance purposes so long as reasonable access to the Premises remains available;

(c) To designate other land outside the boundaries of the Project to be a part of the Common Areas;

(d) To add additional buildings and improvements to the Common Areas;

(e) To use the Common Areas while engaged in making additional improvements, repairs or alterations to the Project, or any portion thereof; and

(f) To do and perform such other acts and make such other changes in, to or with respect to the Common Areas and Project as Lessor may, in the exercise of sound business judgment, deem to be appropriate.

3. Term.

3.1 Term. The Commencement Date, Expiration Date and Original Term of this Lease are as specified in Paragraph 1.3.

3.2 Early Possession. Any provision herein granting Lessee Early Possession of the Premises is subject to and conditioned upon the Premises being available for such possession prior to the Commencement Date. Any grant of Early Possession only conveys a non-exclusive right to occupy the Premises. If Lessee totally or partially occupies the Premises prior to the Commencement Date, the obligation to pay Base Rent shall be abated for the period of such Early Possession. All other terms of this Lease (including but not limited to the obligations to pay Lessee’s Share of the Operating Expense Increase) shall be in effect during such period. Any such Early Possession shall not affect the Expiration Date.

3.3 Delay In Possession. Lessor agrees to use its best commercially reasonable efforts to deliver possession of the Premises to Lessee by the Commencement Date. If, despite said efforts, Lessor is unable to deliver possession by such date, Lessor shall not be subject to any liability therefor, nor shall such failure affect the validity of this Lease or change the Expiration Date. Lessee shall not, however, be obligated to pay Rent or perform its other obligations until Lessor delivers possession of the Premises and any period of rent abatement that Lessee would otherwise have enjoyed shall run from the date of delivery of possession and continue for a period equal to what Lessee would otherwise have enjoyed under the terms hereof, but minus any days of delay caused by the acts or omissions of Lessee. If possession is not delivered within 60 90 days after the Commencement Date, as the same may be extended under the terms of any Work Letter executed be Parties, Lessee may, at its option, by notice in writing within 10 days after the end of such 60 90 day period, cancel this Lease, in which event the Parties shall be discharged from all obligations hereunder. If such written notice is not received by Lessor within said 10 day period, Lessee’s right to cancel shall terminate. If possession of the Premises is not delivered within 120 days after the Commencement Date, this Lease shall terminate unless other agreements are reached between Lessor and Lessee, in writing.

3.4 Lessee Compliance. Lessor shall not be required to deliver possession of the Premises to Lessee until Lessee complies with its obligation to provide evidence of insurance (Paragraph 8.5). Pending delivery of such evidence, Lessee shall be required to perform all of its obligations under this Lease from and after the Start Date, including the payment of Rent, notwithstanding Lessor’s election to withhold possession pending receipt of such evidence of insurance. Further, if Lessee is required to perform any other conditions prior to or concurrent with the Start Date, the Start Date shall occur but Lessor may elect to withhold possession until such conditions are satisfied.

4. Rent.

4.1. Rent Defined. All monetary obligations of Lessee to Lessor under the terms of this Lease (except for the Security Deposit) are deemed to be rent (“Rent”).

4.2 Operating Expense Increase. Lessee shall pay to Lessor during the term hereof, in addition to the Base Rent, Lessee’s Share (as specified in Paragraph 1.6) of the amount by which all Operating Expenses for each Comparison Year exceeds the amount of all Operating Expenses for the Base Year (i.e., 2016 as defined under the Base Year provided in Paragraph 1.9), such excess being hereinafter referred to as the “Operating Expense Increase”, in accordance with the following provisions:

(a) “Base Year” is as specified in Paragraph 1.9.

(b) “Comparison Year” is defined as each calendar year during the term of this Lease subsequent to the Base Year; provided, however, Lessee shall have no obligation to pay a share of the Operating Expense Increase applicable to the first 12 months of the Lease Term (other than such as are mandated by a governmental authority, as to which government mandated expenses Lessee shall pay Lessee’s Share, notwithstanding they occur during the first twelve (12) months). Lessee’s Share of the Operating Expense Increase for the first and last Comparison Years of the Lease Term shall be prorated according to that portion of such Comparison Year as to which Lessee is responsible for a share of such increase.

(c) The following costs relating to the ownership and operation of the Project, calculated as if the Project was at least 95% occupied, are defined as “Operating Expenses” :

(i) Costs relating to the operation, replacement, repair, and maintenance in neat, clean, safe, good order and condition, but not the replacement (see subparagraph (g)), of the following:

(aa) The Common Areas, including their surfaces, coverings, decorative items, carpets, drapes and window coverings, and including parking areas, loading and unloading areas, trash areas, roadways, sidewalks, walkways, stairways, parkways, driveways, landscaped areas, striping, bumpers, irrigation systems, Common Area lighting facilities, building exteriors and roofs, fences and gates

 

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(bb) All heating, air conditioning, plumbing, electrical systems, life safety equipment, communication systems and other equipment used in common by, or for the benefit of, tenants or occupants of the Project, including elevators and escalators, tenant directories, fire detection systems including sprinkler system maintenance and repair.

(cc) All other areas and improvements that are within the exterior boundaries of the Project but outside of the Premises and/or any other space occupied by a tenant.

(ii) The cost of trash disposal, janitorial and security services, pest control services, and the costs of any environmental inspections;

(iii) The cost of any other service to be provided by Lessor that is elsewhere in this Lease stated to be an “Operating Expense”;

(iv) The cost of the premiums for the insurance policies maintained by Lessor pursuant to paragraph 8 and any deductible portion of an insured loss concerning the Building or the Common Areas;

(v) The amount of the Real Property Taxes payable by Lessor pursuant to paragraph 10;

(vi) The cost of water, sewer, gas, electricity, and other publicly mandated services not separately metered;

(vii) Labor, salaries, and applicable fringe benefits and costs, materials, supplies and tools, used in maintaining and/or cleaning the Project and accounting and management fees attributable to the operation of the Project;

(viii) The cost of any capital improvement to the Building or the Project not covered under the provisions of Paragraph 2.3 provided; however, that Lessor shall allocate the cost of any such capital improvement over a 12 year period and Lessee shall not be required to pay more than Lessee’s Share of 1/144th of the cost of such Capital Expenditure in any given month;

(ix) The cost to replace equipment or improvements that have a useful life for accounting purposes of 5 years or less.

(x) Reserves set aside for maintenance, repair and/or replacement of Common Area improvements and equipment.

(d) Any item of Operating Expense that is specifically attributable to the Premises, the Building or to any other building in the Project or to the operation, repair and maintenance thereof, shall be allocated entirely to such Premises, Building, or other building. However, any such item that is not specifically attributable to the Building or to any other building or to the operation, repair and maintenance thereof, shall be equitably allocated by Lessor to all buildings in the Project.

(e) The inclusion of the improvements, facilities and services set forth in Subparagraph 4.2(c) shall not be deemed to impose an obligation upon Lessor to either have said improvements or facilities or to provide those services unless the Project already has the same, Lessor already provides the services, or Lessor has agreed elsewhere in this Lease to provide the same or some of them.

(f) Lessee’s Share of Operating Expense Increase is payable monthly on the same day as the Base Rent is due hereunder. The amount of such payments shall be based on Lessor’s estimate of the Operating Expense Expenses. Within 60 days after written request (but not more than once each year) Lessor shall deliver to Lessee a reasonably detailed statement showing Lessee’s Share of the actual Common Area Operating Expenses for the preceding year. If Lessee’s payments during such Year exceed Lessee’s Share, Lessee shall credit the amount of such over-payment against Lessee’s future payments. If Lessee’s payments during such Year were less than Lessee’s Share, Lessee shall pay to Lessor the amount of the deficiency within 10 days after delivery by Lessor to Lessee of said statement. Lessor and Lessee shall forthwith adjust between them by cash payment any balance determined to exist with respect to that portion of the last Comparison Year for which Lessee is responsible as to Operating Expense Increases, notwithstanding that the Lease term may have terminated before the end of such Comparison Year.

(g) Operating Expenses shall not include the costs of replacement for equipment or capital components such as the roof, foundations. exterior walls or a Common Area capital improvement, such as the parking lot paving , elevators, fences that have a useful life for accounting purposes of 5 years or more.

(h) Operating Expenses shall not include any expenses paid by any tenant directly to third parties, or as to which Lessor is otherwise reimbursed by any third party, other tenant, or by insurance proceeds.

4.3 Payment. Lessee shall cause payment of Rent to be received by Lessor in lawful money of the United States on or before the day on which it is due, without offset or deduction (except as specifically permitted in this Lease). All monetary amounts shall be rounded to the nearest whole dollar. In the event that any invoice prepared by Lessor is inaccurate such inaccuracy shall not constitute a waiver and Lessee shall be obligated to pay the amount set forth in this Lease. Rent for any period during the term hereof which is for less than one full calendar month shall be prorated based upon the actual number of days of said month. Payment of Rent shall be made to Lessor at its address stated herein or to such other persons or place as Lessor may from time to time designate in writing. Acceptance of a payment which is less than the amount then due shall not be a waiver of Lessor’s rights to the balance of such Rent, regardless of Lessor’s endorsement of any check so stating. In the event that any check, draft, or other instrument of payment given by Lessee to Lessor is dishonored for any reason, Lessee agrees to pay to Lessor the sum of $25 in addition to any Late Charge and Lessor, at its option, may require all future Rent be paid by cashier’s check. Payments will be applied first to accrued late charges and attorney’s fees, second to accrued interest, then to Base Rent and Common Area Operating Expenses, and any remaining amount to any other outstanding charges or costs.

5. Security Deposit. Lessee shall deposit with Lessor upon execution hereof the Security Deposit as security for Lessee’s faithful performance of its obligations under this Lease. If Lessee fails to pay Rent, or otherwise Defaults under this Lease, Lessor may use, apply or retain all or any portion of said Security Deposit for the payment of any amount already due Lessor, for Rents which will be due in the future, and/ or to reimburse or compensate Lessor for any liability, expense, loss or damage which Lessor may suffer or incur by reason thereof. Lessor may use, apply or retain all or any portion of the Security Deposit (i) first, for Lessee’s repair obligations, including without limitation, the obligation to restore the Premises to the condition required under this Lease, (ii) second, to the payment of any rent or other sum in default or for the payment of any other sum to which Lessee may become obligated by reason of Lessee’s default, and (iii) third, to compensate Lessor for any loss or damage which Lessor may suffer thereby. If Lessor uses or applies all or any portion of the Security Deposit, Lessee shall within 10 days after written request therefor deposit monies with Lessor sufficient to restore said Security Deposit to the full amount required by this Lease. If the Base Rent increases during the term of this Lease, Lessee shall, upon written request from Lessor, deposit additional monies with Lessor so that the total amount of the Security Deposit shall at all times bear the same proportion to the increased Base Rent as the initial Security Deposit bore to the initial Base Rent. Should the Agreed Use be amended to accommodate a material change in the business of Lessee or to accommodate a sublessee or assignee, Lessor shall have the right to increase the Security Deposit to the extent necessary, in Lessor’s reasonable judgment, to account for any increased wear and tear that the Premises may suffer as a result thereof. If a change in control of Lessee occurs during this Lease and following such change the financial condition of Lessee is, in Lessor’s reasonable judgment, significantly reduced, Lessee shall deposit such additional monies with Lessor as shall be sufficient to cause the Security Deposit to be at a commercially reasonable level based on such change in financial condition. Lessor shall not be required to keep the Security Deposit separate from its general accounts. Within 90 days after the expiration or termination of this Lease, Lessor shall return that portion of the Security Deposit not used or applied by Lessor. No part of the Security Deposit shall be considered to be held in trust, to bear interest or to be prepayment for any monies to be paid by Lessee under this Lease.

6. Use.

6.1 Use. Lessee shall use and occupy the Premises only for the Agreed Use, or any other legal use which is reasonably comparable thereto, and for no other purpose. Lessee shall not use or permit the use of the Premises in a manner that is unlawful, creates damage, waste or a nuisance, or that disturbs occupants of or causes damage to neighboring premises or properties. Other than guide, signal, and seeing eye dogs, and validated service animals, subject to Lessor’s prior approval, Lessee shall not keep or allow in the Premises any pets, animals, birds fish, or reptiles. Lessor shall not unreasonably withhold or delay its consent to any written request for a modification of the Agreed Use, so long as the same will not impair the structural integrity of the improvements of the Building, will not adversely affect the mechanical, electrical, HVAC, and other systems of the Building, and/or will not affect the exterior appearance of the Building. If Lessor elects to withhold consent, Lessor shall within 7 days after such request give written notification of same, which notice shall include an explanation of Lessor’s objections to the change in the Agreed Use.

6.2 Hazardous Substances.

(a) Reportable Uses Require Consent. The term “Hazardous Substance” as used in this Lease shall mean any product, substance, or waste whose presence, use, manufacture, disposal, transportation, or release, either by itself or in combination with other materials expected to be on the Premises, is either: (i) potentially injurious to the public health, safety or welfare, the environment or the Premises, (ii) regulated or monitored by any governmental authority, or (iii) a basis for potential liability of Lessor to any governmental agency or third party under any applicable statute or common law theory. Hazardous Substances shall include, but not be limited to, hydrocarbons, petroleum, gasoline, and/or crude oil or any products, byproducts or fractions thereof. Lessee shall not engage in any activity in or on the Premises which constitutes a Reportable Use of Hazardous Substances without the express prior written consent of Lessor and timely compliance (at Lessee’s expense) with all Applicable Requirements. “Reportable Use” shall mean (i) the installation or use of any above or below ground storage tank, (ii) the generation, possession, storage , use, transportation, or disposal of a Hazardous Substance that requires a permit from, or with respect to which a report, notice, registration or

 

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business plan is required to be filed with, any governmental authority, and/or (iii) the presence at the Premises of a Hazardous Substance with respect to which any Applicable Requirements requires that a notice be given to persons entering or occupying the Premises or neighboring properties. Notwithstanding the foregoing, Lessee may use any ordinary and customary materials reasonably required to be used in the normal course of the Agreed Use such as ordinary office supplies (copier toner, liquid paper, glue, etc.) and common household cleaning materials, so long as such use is in compliance with all Applicable Requirements, is not a Reportable Use, and does not expose the Premises or neighboring property to any meaningful risk of contamination or damage or expose Lessor to any liability therefor. In addition, Lessor may condition its consent to any Reportable Use upon receiving such additional assurances as Lessor reasonably deems necessary to protect itself, the public, the Premises and/or the environment against damage, contamination, injury and/or liability, including, but not limited to, the installation (and removal on or before Lease expiration or termination) of protective modifications (such as concrete encasements) and/or increasing the Security Deposit.

(b) Duty to Inform Lessor. If Lessee knows, or has reasonable cause to believe, that a Hazardous Substance has come to be located in, on, under or about the Premises, other than as previously consented to by Lessor, Lessee shall immediately give written notice of such fact to Lessor, and provide Lessor with a copy of any report, notice, claim or other documentation which it has concerning the presence of such Hazardous Substance.

(c) Lessee Remediation. Lessee shall not cause or permit any Hazardous Substance to be spilled or released in, on, under, or about the Premises (including through the plumbing or sanitary sewer system) and shall promptly, at Lessee’s expense, comply with all Applicable Requirements and take all investigatory and/or remedial action reasonably recommended, whether or not formally ordered or required, for the cleanup of any contamination of, and for the maintenance, security and/or monitoring of the Premises or neighboring properties, that was caused or materially contributed to by Lessee, or pertaining to or involving any Hazardous Substance brought onto the Premises during the term of this Lease, by or for Lessee, or any third party.

(d) Lessee Indemnification. Lessee shall indemnify, defend and hold Lessor, its agents, employees, lenders and ground lessor, if any, harmless from and against any and all loss of rents and/or damages, liabilities, judgments, claims, expenses, penalties, and attorneys’ and consultants’ fees arising out of or involving any Hazardous Substance brought onto the Premises by or for Lessee, or any third party (provided, however, that Lessee shall have no liability under this Lease with respect to underground migration of any Hazardous Substance under the Premises from areas outside of the Project not caused or contributed to by Lessee). Lessee’s obligations shall include, but not be limited to, the effects of any contamination or injury to person, property or the environment created or suffered by Lessee, and the cost of investigation, removal, remediation, restoration and/or abatement, and shall survive the expiration or termination of this Lease. No termination, cancellation or release agreement entered into by Lessor and Lessee shall release Lessee from its obligations under this Lease with respect to Hazardous Substances, unless specifically so agreed by Lessor in writing at the time of such agreement.

(e) Lessor Indemnification. Lessor and its successors and assigns shall indemnify, defend, reimburse and hold Lessee, its employees and lenders, harmless from and against any and all environmental damages, including the cost of remediation, which result from Hazardous Substances which existed on the Premises prior to Lessee’s occupancy or which are caused by the gross negligence or willful misconduct of Lessor, its agents or employees. Lessor’s obligations, as and when required by the Applicable Requirements, shall include, but not be limited to, the cost of investigation, removal, remediation, restoration and/or abatement, and shall survive the expiration or termination of this Lease.

(f) Investigations and Remediations. Lessor shall retain the responsibility and pay for any investigations or remediation measures required by governmental entities having jurisdiction with respect to the existence of Hazardous Substances on the Premises prior to Lessee’s occupancy, unless such remediation measure is required as a result of Lessee’s use (including “Alterations”, as defined in paragraph 7.3(a) below) of the Premises, in which event Lessee shall be responsible for such payment. Lessee shall cooperate fully in any such activities at the request of Lessor, including allowing Lessor and Lessor’s agents to have reasonable access to the Premises at reasonable times in order to carry out Lessor’s investigative and remedial responsibilities.

(g) Lessor Termination Option. If a Hazardous Substance Condition (see Paragraph 9.1(e)) occurs during the term of this Lease, unless Lessee is legally responsible therefor (in which case Lessee shall make the investigation and remediation thereof required by the Applicable Requirements and this Lease shall continue in full force and effect, but subject to Lessor’s rights under Paragraph 6.2(d) and Paragraph 13), Lessor may, at Lessor’s option, either (i) investigate and remediate such Hazardous Substance Condition, if required, as soon as reasonably possible at Lessor’s expense, in which event this Lease shall continue in full force and effect, or (ii) if the estimated cost to remediate such condition exceeds 12 times the then monthly Base Rent or $100,000, whichever is greater, give written notice to Lessee, within 30 days after receipt by Lessor of knowledge of the occurrence of such Hazardous Substance Condition, of Lessor’s desire to terminate this Lease as of the date 60 days following the date of such notice. In the event Lessor elects to give a termination notice, Lessee may, within 10 days thereafter, give written notice to Lessor of Lessee’s commitment to pay the amount by which the cost of the remediation of such Hazardous Substance Condition exceeds an amount equal to 12 times the then monthly Base Rent or $100,000, whichever is greater. Lessee shall provide Lessor with said funds or satisfactory assurance thereof within 30 days following such commitment. In such event, this Lease shall continue in full force and effect, and Lessor shall proceed to make such remediation as soon as reasonably possible after the required funds are available. If Lessee does not give such notice and provide the required funds or assurance thereof within the time provided, this Lease shall terminate as of the date specified in Lessor’s notice of termination.

6.3 Lessee’s Compliance with Applicable Requirements. Except as otherwise provided in this Lease, Lessee shall, at Lessee’s sole expense and regardless of the cost therefore or the time remaining on the term, fully, diligently and in a timely manner, materially comply with all Applicable Requirements, the requirements of any applicable fire insurance underwriter or rating bureau, and the recommendations of Lessor’s engineers and/or consultants which relate in any manner to the Premises, without regard to whether said requirements are now in effect or become effective after the Start Date. Lessee shall, within 10 days after receipt of Lessor’s written request, provide Lessor with copies of all permits and other documents, and other information evidencing Lessee’s compliance with any Applicable Requirements specified by Lessor, and shall immediately upon receipt, notify Lessor in writing (with copies of any documents involved) of any threatened or actual claim, notice, citation, warning, complaint or report pertaining to or involving the failure of Lessee or the Premises to comply with any Applicable Requirements. Likewise, Lessee shall immediately give written notice to Lessor of: (i) any water damage to the Premises and any suspected seepage, pooling, dampness or other condition conducive to the production of mold; or (ii) any mustiness or other odors that might indicate the presence of mold in the Premises.

6.4 Inspection; Compliance. Lessor and Lessor’s Lender (as defined in Paragraph 30) and consultants shall have the right to enter into Premises at any time, in the case of an emergency, and otherwise at reasonable times, after reasonable notice, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease. The cost of any such inspections shall be paid by Lessor, unless a violation of Applicable Requirements, or a Hazardous Substance Condition (see paragraph 9.1e) is found to exist or be imminent, or the inspection is requested or ordered by a governmental authority. In such case, Lessee shall upon request reimburse Lessor for the cost of such inspection, so long as such inspection is reasonably related to the violation or contamination. In addition, Lessee shall provide copies of all relevant material safety data sheets (MSDS) to Lessor within 10 days of the receipt of written request therefor.

7. Maintenance; Repairs; Utility Installations; Trade Fixtures and Alterations.

7.1 Lessee’s Obligations. Notwithstanding Lessor’s obligation to keep the Premises in good condition and repair, Lessee shall be responsible for payment of the cost thereof to Lessor as additional rent for that portion of the cost of any maintenance and repair of the Premises, or any equipment (wherever located) that serves only Lessee or the Premises, to the extent such cost is attributable to abuse or misuse. In addition, Lessee rather than the Lessor shall be responsible for the cost of painting, repairing or replacing wall coverings, and to repair or replace any similar improvements within the Premises. Lessor may, at its option, upon reasonable notice, elect to have Lessee perform any particular such maintenance or repairs the cost of which is otherwise Lessee’s responsibility hereunder.”

7.2 Lessor’s Obligations. Subject to the provisions of Paragraphs 2.2 (Condition), 2.3 (Compliance), 4.2 (Operating Expenses), 6 (Use), 7.1 (Lessee’s Obligations), 9 (Damage or Destruction) and 14 (Condemnation), Lessor, subject to reimbursement pursuant to Paragraph 4.2, shall keep in good order, condition and repair the foundations, exterior walls, structural condition of interior bearing walls, exterior roof, fire sprinkler system (excluding fire sprinkler systems, if any installed by or on behalf of Lessee, for which Lessee shall be responsible), common area fire alarm and/or smoke detection systems, fire hydrants, and parking lots (driveways) serving the Common Areas and all parts thereof. Lessee expressly waives the benefit of any statute now or hereafter in effect to the extent it is inconsistent with the terms of this Lease.

7.3 Utility Installations; Trade Fixtures; Alterations.

(a) Definitions. The term Utility Installations refers to all floor and window coverings, air lines, vacuum lines, power panels, electrical distribution, security and fire protection systems, communication cabling, lighting fixtures, HVAC equipment, and plumbing in or on the Premises. The term Trade Fixtures shall mean Lessee’s machinery and equipment that can be removed without doing material damage to the Premises. The term Alterations shall mean any modification of the improvements, other than Utility Installations or Trade Fixtures, whether by addition or deletion. Lessee Owned Alterations and/or Utility Installations are defined as Alterations and/or Utility Installations made by Lessee that are not yet owned by Lessor pursuant to Paragraph 7.4(a).

(b) Consent. Lessee shall not make any Alterations or Utility Installations to the Premises without Lessor’s prior written consent. Lessee may, however, make non-structural Alterations or Utility Installations to the interior of the Premises (excluding the roof) without such consent but upon notice to Lessor, as long as they are not visible from the outside, do not involve puncturing, relocating or removing the roof, ceilings, floors or any existing walls, will not affect the electrical, plumbing, HVAC, and/or life safety systems, and the cumulative cost thereof during this Lease as extended

 

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does not exceed $2000. Notwithstanding the foregoing, Lessee shall not make or permit any roof penetrations and/or install anything on the roof without the prior written approval of Lessor. Lessor may, as a precondition to granting such approval, require Lessee to utilize a contractor chosen and/or approved by Lessor. Any Alterations or Utility Installations that Lessee shall desire to make and which require the consent of the Lessor shall be presented to Lessor in written form with detailed plans. Consent shall be deemed conditioned upon Lessee’s: (i) acquiring all applicable governmental permits, (ii) furnishing Lessor with copies of both the permits and the plans and specifications prior to commencement of the work, and (iii) compliance with all conditions of said permits and other Applicable Requirements in a prompt and expeditious manner. Any Alterations or Utility Installations shall be performed in a workmanlike manner with good and sufficient materials. Lessee shall promptly upon completion furnish Lessor with asbuilt plans and specifications. For work which costs an amount in excess of one month’s Base Rent, Lessor may condition its consent upon Lessee providing a lien and completion bond in an amount equal to 150% of the estimated cost of such Alteration or Utility Installation and/or upon Lessee’s posting an additional Security Deposit with Lessor.

(c) Liens; Bonds. Lessee shall pay, when due, all claims for labor or materials furnished or alleged to have been furnished to or for Lessee at or for use on the Premises, which claims are or may be secured by any mechanic’s or materialmen’s lien against the Premises or any interest therein. Lessee shall give Lessor not less than 10 days notice prior to the commencement of any work in, on or about the Premises, and Lessor shall have the right to post notices of non-responsibility. If Lessee shall contest the validity of any such lien, claim or demand, then Lessee shall, at its sole expense defend and protect itself, Lessor and the Premises against the same and shall pay and satisfy any such adverse judgment that may be rendered thereon before the enforcement thereof. If Lessor shall require, Lessee shall furnish a surety bond in an amount equal to 150% of the amount of such contested lien, claim or demand, indemnifying Lessor against liability for the same. If Lessor elects to participate in any such action, Lessee shall pay Lessor’s attorneys’ fees and costs.

7.4 Ownership; Removal; Surrender; and Restoration.

(a) Ownership. Subject to Lessor’s right to require removal or elect ownership as hereinafter provided, all Alterations and Utility Installations made by Lessee shall be the property of Lessee, but considered a part of the Premises. Lessor may, at any time, elect in writing to be the owner of all or any specified part of the Lessee Owned Alterations and Utility Installations. Unless otherwise instructed per paragraph 7.4(b) hereof, all Lessee Owned Alterations and Utility Installations shall, at the expiration or termination of this Lease, become the property of Lessor and be surrendered by Lessee with the Premises.

(b) Removal. By delivery to Lessee of written notice from Lessor not earlier than 90 days before, and not later than 30 days after prior to the end of the term of this Lease, Lessor may require that any or all Lessee Owned Alterations or Utility Installations be removed by the expiration or termination of this Lease (or within ten (10) days after delivery of Lessor’s notice, if such notice is delivered after the expiration of the term). Lessor may require the removal at any time of all or any part of any Lessee Owned Alterations or Utility Installations made without the required consent. This paragraph 7.4(b) shall be subject to the provisions of Paragraph 7.4(b) in the Addendum of the Lease.

(c) Surrender; Restoration. Lessee shall surrender the Premises by the Expiration Date or any earlier termination date, with all of the improvements, parts and surfaces thereof clean and free of debris, and in good operating order, condition and state of repair, ordinary wear and tear excepted. “Ordinary wear and tear” shall not include any damage or deterioration that would have been prevented by good maintenance practice. Notwithstanding the foregoing, if this Lease is for 12 months or less, then Lessee shall surrender the Premises in the same condition as delivered to Lessee on the Start Date with NO allowance for ordinary wear and tear. Lessee shall repair any damage occasioned by the installation, maintenance or removal of Trade Fixtures, Lessee owned Alterations and/or Utility Installations, furnishings, and equipment as well as the removal of any storage tank installed by or for Lessee. Lessee shall also completely remove from the Premises any and all Hazardous Substances brought onto the Premises by or for Lessee, or any third party (except Hazardous Substances which were deposited via underground migration from areas outside of the Premises) even if such removal would require Lessee to perform or pay for work that exceeds statutory requirements. Trade Fixtures shall remain the property of Lessee and shall be removed by Lessee. Any personal property of Lessee not removed on or before the Expiration Date or any earlier termination date shall be deemed to have been abandoned by Lessee and may be disposed of or retained by Lessor as Lessor may desire. The failure by Lessee to timely vacate the Premises pursuant to this Paragraph 7.4(c) without the express written consent of Lessor shall constitute a holdover under the provisions of Paragraph 26 below.

8. Insurance; Indemnity.

8.1 Insurance Premiums. The cost of the premiums for the insurance policies maintained by Lessor pursuant to paragraph 8 are included as Operating Expenses (see paragraph 4.2 (c)(iv)). Said costs shall include increases in the premiums resulting from additional coverage related to requirements of the holder of a mortgage or deed of trust covering the Premises, Building and/or Project, increased valuation of the Premises, Building and/or Project, and/or a general premium rate increase. Said costs shall not, however, include any premium increases resulting from the nature of the occupancy of any other tenant of the Building. If the Project was not insured for the entirety of the Base Year, then the base premium shall be the lowest annual premium reasonably obtainable for the required insurance as of the Start Date, assuming the most nominal use possible of the Building and/or Project. In no event, however, shall Lessee be responsible for any portion of the premium cost attributable to liability insurance coverage in excess of $2,000,000 procured under Paragraph 8.2(b).

8.2 Liability Insurance.

(a) Carried by Lessee. Lessee shall obtain and keep in force a Commercial General Liability policy of insurance protecting Lessee and Lessor as an additional insured against claims for bodily injury, personal injury and property damage based upon or arising out of the ownership, use, occupancy or maintenance of the Premises and all areas appurtenant thereto. Such insurance shall be on an occurrence basis providing single limit coverage in an amount not less than $1,000,000 per occurrence with an annual aggregate of not less than $2,000,000. Lessee shall add Lessor as an additional insured by means of an endorsement at least as broad as the Insurance Service Organization’s “Additional Insured-Managers or Lessors of Premises” Endorsement and coverage shall also be extended to include damage caused by heat, smoke or fumes from a hostile fire. The policy shall not contain any intra-insured exclusions as between insured persons or organizations, but shall include coverage for liability assumed under this Lease as an insured contract for the performance of Lessee’s indemnity obligations under this Lease. The limits of said insurance shall not, however, limit the liability of Lessee nor relieve Lessee of any obligation hereunder. Lessee shall provide an endorsement on its liability policy(ies) which provides that its insurance shall be primary to and not contributory with any similar insurance carried by Lessor, whose insurance shall be considered excess insurance only.

(b) Carried by Lessor. Lessor shall maintain liability insurance as described in Paragraph 8.2(a), in addition to, and not in lieu of, the insurance required to be maintained by Lessee. Lessee shall not be named as an additional insured therein.

8.3 Property Insurance—Building, Improvements and Rental Value.

(a) Building and Improvements. Lessor shall obtain and keep in force a policy or policies of insurance in the name of Lessor, with loss payable to Lessor, any ground-lessor, and to any Lender insuring loss or damage to the Building and/or Project. The amount of such insurance shall be equal to the full insurable replacement cost of the Building and/or Project, as the same shall exist from time to time, or the amount required by any Lender, but in no event more than the commercially reasonable and available insurable value thereof. Lessee Owned Alterations and Utility Installations, Trade Fixtures, and Lessee’s personal property shall be insured by Lessee not by Lessor. If the coverage is available and commercially appropriate, such policy or policies shall insure against all risks of direct physical loss or damage (except the perils of flood and/or earthquake unless required by a Lender), including coverage for debris removal and the enforcement of any Applicable Requirements requiring the upgrading, demolition, reconstruction or replacement of any portion of the Premises as the result of a covered loss. Said policy or policies shall also contain an agreed valuation provision in lieu of any coinsurance clause, waiver of subrogation, and inflation guard protection causing an increase in the annual property insurance coverage amount by a factor of not less than the adjusted U.S. Department of Labor Consumer Price Index for All Urban Consumers for the city nearest to where the Premises are located. If such insurance coverage has a deductible clause, Lessee shall be liable for such deductible amount in the event of an Insured Loss the deductible amount shall not exceed $5,000 per occurrence.

(b) Rental Value. Lessor shall also obtain and keep in force a policy or policies in the name of Lessor with loss payable to Lessor and any Lender, insuring the loss of the full Rent for one year with an extended period of indemnity for an additional 180 days (“Rental Value insurance”). Said insurance shall contain an agreed valuation provision in lieu of any coinsurance clause, and the amount of coverage shall be adjusted annually to reflect the projected Rent otherwise payable by Lessee, for the next 12 month period.

(c) Adjacent Premises. Lessee shall pay for any increase in the premiums for the property insurance of the Building and for the Common Areas or other buildings in the Project if said increase is caused by Lessee’s acts, omissions, use or occupancy of the Premises.

(d) Lessee’s Improvements. Since Lessor is the Insuring Party, Lessor shall not be required to insure Lessee Owned Alterations and Utility Installations unless the item in question has become the property of Lessor under the terms of this Lease.

8.4 Lessee’s Property; Business Interruption Insurance; Worker’s Compensation Insurance.

(a) Property Damage. Lessee shall obtain and maintain insurance coverage on all of Lessee’s personal property, Trade Fixtures, and Lessee Owned Alterations and Utility Installations. Such insurance shall be full replacement cost coverage with a deductible of not to exceed $ 1, 000 per occurrence. The proceeds from any such insurance shall be used by Lessee for the replacement of personal property, Trade Fixtures and Lessee Owned Alterations and Utility Installations. Lessee shall provide Lessor with written evidence that such insurance is in force.

 

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(b) Worker’s Compensation Insurance. Lessee shall obtain and maintain Worker’s Compensation Insurance in such amount as may be required by Applicable Requirements.

(c) Business Interruption. Lessee shall obtain and maintain loss of income and extra expense insurance in amounts as will reimburse Lessee for direct or indirect loss of earnings attributable to all perils commonly insured against by prudent lessees in the business of Lessee or attributable to prevention of access to the Premises as a result of such perils.

(d) No Representation of Adequate Coverage. Lessor makes no representation that the limits or forms of coverage of insurance specified herein are adequate to cover Lessee’s property, business operations or obligations under this Lease.

8.5 Insurance Policies. Insurance required herein shall be by companies maintaining during the policy term a “General Policyholders Rating” of at least A-, VII, as set forth in the most current issue of “Best’s Insurance Guide”, or such other rating as may be required by a Lender. Lessee shall not do or permit to be done anything which invalidates the required insurance policies. Lessee shall, prior to the Start Date, deliver to Lessor certified copies of policies of such insurance or certificates with copies of the required endorsements evidencing the existence and amounts of the required insurance. No such policy shall be cancelable or subject to modification except after 10 days prior written notice to Lessor. Lessee shall, at least 30 days prior to the expiration of such policies, furnish Lessor with evidence of renewals or “insurance binders” evidencing renewal thereof, or Lessor may order such insurance and charge the cost thereof to Lessee, which amount shall be payable by Lessee to Lessor upon demand. Such policies shall be for a term of at least one year, or the length of the remaining term of this Lease, whichever is less. If either Party shall fail to procure and maintain the insurance required to be carried by it, the other Party may, but shall not be required to, procure and maintain the same.

8.6 Waiver of Subrogation. Without affecting any other rights or remedies. Lessee and Lessor each hereby release and relieve the other, and waive their entire right to recover damages against the other, for loss of or damage to its property arising out of or incident to the perils required to be insured against herein. The effect of such releases and waivers is not limited by the amount of insurance carried or required, or by any deductibles applicable hereto. The Parties agree to have their respective property damage insurance carriers waive any right to subrogation that such companies may have against Lessor or Lessee, as the case may be, so long as the insurance is not invalidated thereby.

8.7 Indemnity. Except for Lessor’s gross negligence or willful misconduct, Lessee shall indemnify, protect, defend and hold harmless the Premises, Lessor and its agents. Lessor’s master or ground lessor, partners and Lenders, from and against any and all claims, loss of rents and/or damages, liens, judgments, penalties, attorneys’ and consultants’ fees, expenses and/or liabilities arising out of, involving, or in connection with, the use and/or occupancy of the Premises by Lessee. If any action or proceeding is brought against Lessor by reason of any of the foregoing matters. Lessee shall upon notice defend the same at Lessee’s expense by counsel reasonably satisfactory to Lessor and Lessor shall cooperate with Lessee in such defense. Lessor need not have first paid any such claim in order to be defended or indemnified.

8.8 Exemption of Lessor and its Agents from Liability. Notwithstanding the negligence or breach of this Lease by Lessor or its agents, neither Lessor nor its agents shall be liable under any circumstances for: (i) injury or damage to the person or goods, wares, merchandise or other property of Lessee, Lessee’s employees, contractors, invitees, customers, or any other person in or about the Premises, whether such damage or injury is caused by or results from fire, steam, electricity, gas, water or rain, indoor air quality, the presence of mold or from the breakage, leakage, obstruction or other defects of pipes, fire sprinklers, wires, appliances, plumbing, HVAC or lighting fixtures, or from any other cause, whether the said injury or damage results from conditions arising upon the Premises or upon other portions of the Building, or from other sources or places, (ii) any damages arising from any act or neglect of any other tenant of Lessor or from the failure of Lessor or its agents to enforce the provisions of any other lease in the Project, or (iii) injury to Lessee’s business or for any loss of income or profit therefrom or shall Lessor be liable for consequential or punitive damages. Instead, it is intended that Lessee’s sole recourse in the event of such damages or injury be to file a claim on the insurance policy(ies) that Lessee is required to maintain pursuant to the provisions of paragraph 8.

8.9 Failure to Provide Insurance. Lessee acknowledges that any failure on its part to obtain or maintain the insurance required herein will expose Lessor to risks and potentially cause Lessor to incur costs not contemplated by this Lease, the extent of which will be extremely difficult to ascertain. Accordingly, for any month or portion thereof that Lessee does not maintain the required insurance and/or does not provide Lessor with the required binders or certificates evidencing the existence of the required insurance, the Base Rent shall be automatically increased, without any requirement for notice to Lessee, by an amount equal to 10% of the then existing Base Rent or $100, whichever is greater. The parties agree that such increase in Base Rent represents fair and reasonable compensation for the additional risk/costs that Lessor will incur by reason of Lessee’s failure to maintain the required insurance. Such increase in Base Rent shall in no event constitute a waiver of Lessee’s Default or Breach with respect to the failure to maintain such insurance, prevent the exercise of any of the other rights and remedies granted hereunder, nor relieve Lessee of its obligation to maintain the insurance specified in this Lease.

9. Damage or Destruction.

9.1 Definitions.

(a) Premises Partial Damage shall mean damage or destruction to the improvements on the Premises, other than Lessee Owned Alterations and Utility Installations, which can reasonably be repaired in 3 6 months or less from the date of the damage or destruction, and the cost thereof does not exceed a sum equal to 6 month’s Base Rent. Lessor shall notify Lessee in writing within 30 days from the date of the damage or destruction as to whether or not the damage is Partial or Total.

(b) Premises Total Destruction shall mean damage or destruction to the improvements on the Premises, other than Lessee Owned Alterations and Utility Installations and Trade Fixtures, which cannot reasonably be repaired in 3 6 months or less from the date of the damage or destruction and/or the cost thereof exceeds a sum equal to 6 month’s Base Rent. Lessor shall notify Lessee in writing within 30 days from the date of the damage or destruction as to whether or not the damage is Partial or Total.

(c) Insured Loss shall mean damage or destruction to improvements on the Premises, other than Lessee Owned Alterations and Utility Installations and Trade Fixtures, which was caused by an event required to be covered by the insurance described in Paragraph 8.3(a), irrespective of any deductible amounts or coverage limits involved.

(d) Replacement Cost shall mean the cost to repair or rebuild the improvements owned by Lessor at the time of the occurrence to their condition existing immediately prior thereto, including demolition, debris removal and upgrading required by the operation of Applicable Requirements, and without deduction for depreciation.

(e) Hazardous Substance Condition shall mean the occurrence or discovery of a condition involving the presence of, or a contamination by, a Hazardous Substance, in, on, or under the Premises which requires restoration.

9.2 Partial Damage—Insured Loss. If a Premises Partial Damage that is an Insured Loss occurs, then Lessor shall, at Lessor’s expense, repair such damage (but not Lessee’s Trade Fixtures or Lessee Owned Alterations and Utility Installations) as soon as reasonably possible and this Lease shall continue in full force and effect; provided, however, that Lessee shall, at Lessor’s election, make the repair of any damage or destruction the total cost to repair of which is $5,000 or less, and, in such event, Lessor shall make any applicable insurance proceeds available to Lessee on a reasonable basis for that purpose. Notwithstanding the foregoing, if the required insurance was not in force or the insurance proceeds are not sufficient to effect such repair, the Insuring Party shall promptly contribute the shortage in proceeds as and when required to complete said repairs. In the event, however, such shortage was due to the fact that, by reason of the unique nature of the improvements, full replacement cost insurance coverage was not commercially reasonable and available, Lessor shall have no obligation to pay for the shortage in insurance proceeds or to fully restore the unique aspects of the Premises unless Lessee provides Lessor with the funds to cover same, or adequate assurance thereof, within 10 days following receipt of written notice of such shortage and request therefor. If Lessor receives said funds or adequate assurance thereof within said 10 day period, the party responsible for making the repairs shall complete them as soon as reasonably possible and this Lease shall remain in full force and effect. If such funds or assurance are not received, Lessor may nevertheless elect by written notice to Lessee within 10 days thereafter to: (i) make such restoration and repair as is commercially reasonable with Lessor paying any shortage in proceeds, in which case this Lease shall remain in full force and effect, or (ii) have this Lease terminate 30 days thereafter. Lessee shall not be entitled to reimbursement of any funds contributed by Lessee to repair any such damage or destruction. Premises Partial Damage due to flood or earthquake shall be subject to Paragraph 9.3, notwithstanding that there may be some insurance coverage, but the net proceeds of any such insurance shall be made available for the repairs if made by either Party.

9.3 Partial Damage—Uninsured Loss. If a Premises Partial Damage that is not an Insured Loss occurs, unless caused by a negligent or willful act of Lessee (in which event Lessee shall make the repairs at Lessee’s expense), Lessor may either: (i) repair such damage as soon as reasonably possible at Lessor’s expense, in which event this Lease shall continue in full force and effect, or (ii) terminate this Lease by giving written notice to Lessee within 30 days after receipt by Lessor of knowledge of the occurrence of such damage. Such termination shall be effective 60 days following the date of such notice. In the event Lessor elects to terminate this Lease, Lessee shall have the right within 10 days after receipt of the termination notice to give written notice to Lessor of Lessee’s commitment to pay for the repair of such damage without reimbursement from Lessor. Lessee shall provide Lessor with said funds or satisfactory assurance thereof within 30 days after making such commitment. In such event this Lease shall continue in full force and effect, and Lessor shall proceed to make such repairs as soon as reasonably possible after the required funds are available. If Lessee does not make the required commitment, this Lease shall terminate as of the date specified in the termination notice.

9.4 Total Destruction. Notwithstanding any other provision hereof, if a Premises Total Destruction occurs, this Lease shall terminate 60 days following such Destruction. If the damage or destruction was caused by the gross negligence or willful misconduct of Lessee, Lessor shall have the right to recover Lessor’s damages from Lessee, except as provided in Paragraph 8.6.

 

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9.5 Damage Near End of Term. If at any time during the last 6 months of this Lease there is damage for which the cost to repair exceeds one month’s Base Rent, whether or not an Insured Loss, Lessor may terminate this Lease effective 60 days following the date of occurrence of such damage by giving a written termination notice to Lessee within 30 days after the date of occurrence of such damage. Notwithstanding the foregoing, if Lessee at that time has an exercisable option to extend this Lease or to purchase the Premises, then Lessee may preserve this Lease by, (a) exercising such option and (b) providing Lessor with any shortage in insurance proceeds (or adequate assurance thereof) needed to make the repairs on or before the earlier of (i) the date which is 10 days after Lessee’s receipt of Lessor’s written notice purporting to terminate this Lease, or (ii) the day prior to the date upon which such option expires. If Lessee duly exercises such option during such period and provides Lessor with funds (or adequate assurance thereof) to cover any shortage in insurance proceeds, Lessor shall, at Lessor’s commercially reasonable expense, repair such damage as soon as reasonably possible and this Lease shall continue in full force and effect. If Lessee fails to exercise such option and provide such funds or assurance during such period, then this Lease shall terminate on the date specified in the termination notice and Lessee’s option shall be extinguished.

9.6 Abatement of Rent; Lessee’s Remedies.

(a) Abatement. In the event of Premises Partial Damage or Premises Total Destruction or a Hazardous Substance Condition for which Lessee is not responsible under this Lease, the Rent payable by Lessee for the period required for the repair, remediation or restoration of such damage shall be abated in proportion to the degree to which Lessee’s use of the Premises is impaired, but not to exceed the proceeds received from the Rental Value insurance. All other obligations of Lessee hereunder shall be performed by Lessee, and Lessor shall have no liability for any such damage, destruction, remediation, repair or restoration except as provided herein.

(b) Remedies. If Lessor is obligated to repair or restore the Premises and does not commence, in a substantial and meaningful way, such repair or restoration within 90 days after such obligation shall accrue, Lessee may, at any time prior to the commencement of such repair or restoration, give written notice to Lessor and to any Lenders of which Lessee has actual notice, of Lessee’s election to terminate this Lease on a date not less than 60 days following the giving of such notice. If Lessee gives such notice and such repair or restoration is not commenced within 30 days thereafter, this Lease shall terminate as of the date specified in said notice. If the repair or restoration is commenced within such 30 days, this Lease shall continue in full force and effect. “Commence” shall mean either the unconditional authorization of the preparation of the required plans, or the beginning of the actual work on the Premises, whichever first occurs.

9.7 Termination; Advance Payments. Upon termination of this Lease pursuant to Paragraph 6.2(g) or Paragraph 9, an equitable adjustment shall be made concerning advance Base Rent and any other advance payments made by Lessee to Lessor. Lessor shall, in addition, return to Lessee so much of Lessee’s Security Deposit as has not been, or is not then required to be, used by Lessor.

10. Real Property Taxes.

10.1 Definitions. As used herein, the term Real Property Taxes shall include any form of assessment; real estate, general, special, ordinary or extraordinary, or rental levy or tax (other than inheritance, personal income or estate taxes); improvement bond; and/or license fee imposed upon or levied against any legal or equitable interest of Lessor in the Project, Lessor’s right to other income therefrom, and/or Lessor’s business of leasing, by any authority having the direct or indirect power to tax and where the funds are generated with reference to the Project address and where the proceeds so generated are to be applied by the city, county or other local taxing authority of a jurisdiction within which the Project is located. “Real Property Taxes” shall also include any tax, fee, levy, assessment or charge, or any increase therein: (i) imposed by reason of events occurring during the term of this Lease, including but not limited to, a change in the ownership of the Project, (ii) a change in the improvements thereon, and/or (iii) levied or assessed on machinery or equipment provided by Lessor to Lessee pursuant to this Lease.

10.2 Payment of Taxes. Except as otherwise provided in Paragraph 10.3, Lessor shall pay the Real Property Taxes applicable to the Project, and said payments shall be included in the calculation of Operating Expenses in accordance with the provisions of Paragraph 4.2.

10.3 Additional Improvements. Operating Expenses shall not include Real Property Taxes specified in the tax assessor’s records and work sheets as being caused by additional improvements placed upon the Project by other lessees or by Lessor for the exclusive enjoyment of such other lessees. Notwithstanding Paragraph 10.2 hereof, Lessee shall, however, pay to Lessor at the time Operating Expenses are payable under Paragraph 4.2, the entirety of any increase in Real Property Taxes if assessed solely by reason of Alterations, Trade Fixtures or Utility Installations placed upon the Premises by Lessee or at Lessee’s request or by reason of any alterations or improvements to the Premises made by Lessor subsequent to the execution of this Lease by the Parties.

10.4 Joint Assessment. If the Building is not separately assessed. Real Property Taxes allocated to the Building shall be an equitable proportion of the Real Property Taxes for all of the land and improvements included within the tax parcel assessed, such proportion to be determined by Lessor from the respective valuations assigned in the assessor’s work sheets or such other information as may be reasonably available. Lessor’s reasonable determination thereof, in good faith, shall be conclusive.

10.5 Personal Property Taxes. Lessee shall pay prior to delinquency all taxes assessed against and levied upon Lessee Owned Alterations and Utility Installations, Trade Fixtures, furnishings, equipment and all personal property of Lessee contained in the Premises. When possible, Lessee shall cause its Lessee Owned Alterations and Utility Installations, Trade Fixtures, furnishings, equipment and all other personal property to be assessed and billed separately from the real property of Lessor. If any of Lessee’s said property shall be assessed with Lessor’s real property, Lessee shall pay Lessor the taxes attributable to Lessee’s property within 10 days after receipt of a written statement setting forth the taxes applicable to Lessee’s property.

11. Utilities and Services.

11.1 Services Provided by Lessor. Lessor shall provide (i) heating, ventilation, air conditioning, (ii) reasonable amounts of electricity for normal lighting and office machines, and (iii) water for reasonable and normal drinking and lavatory use in connection with an office in each case, during only those hours set forth in Section 1.12 of this Lease, and replacement light bulbs and/or fluorescent tubes and ballasts for standard overhead fixtures. Lessor shall also provide janitorial services to the Premises and Common Areas 5 times per week, excluding Building Holidays, or pursuant to the attached janitorial schedule, if any. Lessor shall not, however, be required to provide janitorial services to kitchens or storage areas included within any portion of the Premises.

11.2 Services Exclusive to Lessee. Lessee shall pay for all water, gas, light, power, telephone and other utilities and services specially or exclusively supplied and/or metered exclusively to the Premises or to Lessee, together with any taxes thereon. If a service is deleted by Paragraph 1.13 and such service is not separately metered to the Premises, Lessee shall pay at Lessor’s option, either Lessee’s Share or a reasonable proportion to be determined by Lessor of all charges for such jointly metered service.

11.3 Hours of Service. Said services and utilities shall be provided during times set forth in Paragraph 1.12. Utilities and services required at other times shall be subject to advance request and reimbursement by Lessee to Lessor of the cost thereof.

11.4 Excess Usage by Lessee. Lessee shall not make connection to the utilities except by or through existing outlets and shall not install or use machinery or equipment in or about the Premises that uses excess water, lighting or power, or suffer or permit any act that causes extra burden upon the utilities or services, including but not limited to security and trash services, over standard office usage for the Project. Lessor shall require Lessee to reimburse Lessor for any excess expenses or costs that may arise out of a breach of this subparagraph by Lessee. Lessor may, in its sole discretion, install at Lessee’s expense supplemental equipment and/or separate metering applicable to Lessee’s excess usage or loading.

11.5 Interruptions. There shall be no abatement of rent and Lessor shall not be liable in any respect whatsoever for the inadequacy, stoppage, interruption or discontinuance of any utility or service due to riot, strike, labor dispute, breakdown, accident, repair or other cause beyond Lessor’s reasonable control or in cooperation with governmental request or directions.

12. Assignment and Subletting.

12.1 Lessor’s Consent Required.

(a) Lessee shall not voluntarily or by operation of law assign, transfer, mortgage or encumber (collectively, assign or assignment) or sublet all or any part of Lessee’s interest in this Lease or in the Premises without Lessor’s prior written consent.

(b) Unless Lessee is a corporation and its stock is publicly traded on a national stock exchange, a change in the control of Lessee shall constitute an assignment requiring consent. The transfer, on a cumulative basis, of 25% or more of the voting control of Lessee shall constitute a change in control for this purpose.

(c) The involvement of Lessee or its assets in any transaction, or series of transactions (by way of merger, sale, acquisition, financing, transfer, leveraged buyout or otherwise), whether or not a formal assignment or hypothecation of this Lease or Lessee’s assets occurs, which results or will result in a reduction of the Net Worth of Lessee by an amount greater than 25% of such Net Worth as it was represented at the time of the execution of this Lease or at the time of the most recent assignment to which Lessor has consented, or as it exists immediately prior to said transaction or transactions constituting such reduction, whichever was or is greater, shall be considered an assignment of this Lease to which Lessor may withhold its consent. Net Worth of Lessee shall mean the net worth of Lessee (excluding any guarantors) established under generally accepted accounting principles.

(d) An assignment or subletting without consent shall, at Lessor’s option, be a Default curable after notice per Paragraph 13.1(c), or a noncurable Breach without the necessity of any notice and grace period. If Lessor elects to treat such unapproved assignment or subletting as a noncurable Breach, Lessor may either: (i) terminate this Lease, or (ii) upon 30 days written notice, increase the monthly Base Rent to 110% of the Base Rent then in effect. Further, in the event of such Breach and rental adjustment, (i) the purchase price of any option to purchase the Premises held by Lessee shall be subject to similar adjustment to 110% of the price previously in effect, and (ii) all fixed and non-fixed rental adjustments scheduled during the remainder of the Lease term shall be increased to 110% of the scheduled adjusted rent.

 

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(e) Lessee’s remedy for any breach of Paragraph 12.1 by Lessor shall be limited to compensatory damages and/or injunctive relief.

(f) Lessor may reasonably withhold consent to a proposed assignment or subletting if Lessee is in Default at the time consent is requested.

(g) Notwithstanding the foregoing, allowing a de minimis portion of the Premises, i e. 20 square feet or less, to be used by a third party vendor in connection with the installation of a vending machine or payphone shall not constitute a subletting.

12.2 Terms and Conditions Applicable to Assignment and Subletting.

(a) Regardless of Lessor’s consent, no assignment or subletting shall: (i) be effective without the express written assumption by such assignee or sublessee of the obligations of Lessee under this Lease, (ii) release Lessee of any obligations hereunder, or (iii) alter the primary liability of Lessee for the payment of Rent or for the performance of any other obligations to be performed by Lessee.

(b) Lessor may accept Rent or performance of Lessee’s obligations from any person other than Lessee pending approval or disapproval of an assignment. Neither a delay in the approval or disapproval of such assignment nor the acceptance of Rent or performance shall constitute a waiver or estoppel of Lessor’s right to exercise its remedies for Lessee’s Default or Breach.

(c) Lessor’s consent to any assignment or subletting shall not constitute a consent to any subsequent assignment or subletting.

(d) In the event of any Default or Breach by Lessee, Lessor may proceed directly against Lessee, any Guarantors or anyone else responsible for the performance of Lessee’s obligations under this Lease, including any assignee or sublessee, without first exhausting Lessor’s remedies against any other person or entity responsible therefore to Lessor, or any security held by Lessor.

(e) Each request for consent to an assignment or subletting shall be in writing, accompanied by information relevant to Lessor’s determination as to the financial and operational responsibility and appropriateness of the proposed assignee or sublessee, including but not limited to the intended use and/or required modification of the Premises, if any, together with a fee of $500 as consideration for Lessor’s considering and processing said request. Lessee agrees to provide Lessor with such other or additional information and/or documentation as may be reasonably requested. (See also Paragraph 36)

(f) Any assignee of, or sublessee under, this Lease shall, by reason of accepting such assignment, entering into such sublease, or entering into possession of the Premises or any portion thereof, be deemed to have assumed and agreed to conform and comply with each and every term, covenant, condition and obligation herein to be observed or performed by Lessee during the term of said assignment or sublease, other than such obligations as are contrary to or inconsistent with provisions of an assignment or sublease to which Lessor has specifically consented to in writing.

(g) Lessor’s consent to any assignment or subletting shall not transfer to the assignee or sublessee any Option granted to the original Lessee by this Lease unless such transfer is specifically consented to by Lessor in writing. (See Paragraph 39.2)

12.3 Additional Terms and Conditions Applicable to Subletting. The following terms and conditions shall apply to any subletting by Lessee of all or any part of the Premises and shall be deemed included in all subleases under this Lease whether or not expressly incorporated therein:

(a) Lessee hereby assigns and transfers to Lessor all of Lessee’s interest in all Rent payable on any sublease, and Lessor may collect such Rent and apply same toward Lessee’s obligations under this Lease; provided, however, that until a Breach shall occur in the performance of Lessee’s obligations, Lessee may collect said Rent. In the event that the amount collected by Lessor exceeds Lessee’s then outstanding obligations any such excess shall be refunded to Lessee. Lessor shall not, by reason of the foregoing or any assignment of such sublease, nor by reason of the collection of Rent, be deemed liable to the sublessee for any failure of Lessee to perform and comply with any of Lessee’s obligations to such sublessee. Lessee hereby irrevocably authorizes and directs any such sublessee, upon receipt of a written notice from Lessor stating that a Breach exists in the performance of Lessee’s obligations under this Lease, to pay to Lessor all Rent due and to become due under the sublease. Sublessee shall rely upon any such notice from Lessor and shall pay all Rents to Lessor without any obligation or right to inquire as to whether such Breach exists, notwithstanding any claim from Lessee to the contrary.

(b) In the event of a Breach by Lessee, Lessor may, at its option, require sublessee to attorn to Lessor, in which event Lessor shall undertake the obligations of the sublessor under such sublease from the time of the exercise of said option to the expiration of such sublease; provided, however, Lessor shall not be liable for any prepaid rents or security deposit paid by such sublessee to such sublessor or for any prior Defaults or Breaches of such sublessor.

(c) Any matter requiring the consent of the sublessor under a sublease shall also require the consent of Lessor.

(d) No sublessee shall further assign or sublet all or any part of the Premises without Lessor’s prior written consent.

(e) Lessor shall shall not be required to deliver a copy of any notice of Default or Breach by Lessee to the sublessee, who shall not have the right to cure the any Default of Lessee within the grace period, if any, specified in such notice. The sublessee shall have a right of reimbursement and offset from and against Lessee for any such Defaults cured by the sublessee.

13. Default; Breach; Remedies.

13.1 Default; Breach. A Default is defined as a failure by the Lessee to comply with or perform any of the terms, covenants, conditions or Rules and Regulations under this Lease. A “Breach” is defined as the occurrence of one or more of the following Defaults, and the failure of Lessee to cure such Default within any applicable grace period:

(a) The abandonment of the Premises; or the vacating of the Premises without providing a commercially reasonable level of security, or where the coverage of the property insurance described in Paragraph 8.3 is jeopardized as a result thereof, or without providing reasonable assurances to minimize potential vandalism, or where Lessor reasonably determines that such abandonment materially and adversely impacts Lessor’s ability to sell or obtain financing for the Premises or any portion thereof.

(b) The failure of Lessee to make any payment of Rent or any Security Deposit required to be made by Lessee hereunder , whether to Lessor or to a third party, when due, to provide reasonable evidence of insurance or surety bond, or to fulfill any obligation under this Lease which endangers or threatens life or property, where such failure continues for a period of 3 business days following written notice to Lessee. THE ACCEPTANCE BY LESSOR OF A PARTIAL PAYMENT OF RENT OR SECURITY DEPOSIT SHALL NOT CONSTITUTE A WAIVER OF ANY OF LESSOR’S RIGHTS, INCLUDING LESSOR’S RIGHT TO RECOVER POSSESSION OF THE PREMISES.

(c) The failure of Lessee to allow Lessor and/or its agents access to the Premises or the commission of waste, act or acts constituting public or private nuisance, and/or an illegal activity on the Premises by Lessee, where such actions continue for a period of 3 business days following written notice to Lessee.

(d) The failure by Lessee to provide (i) reasonable written evidence of compliance with Applicable Requirements, (ii) the service contracts, (iii) the rescission of an unauthorized assignment or subletting, (iv) an Estoppel Certificate or financial statements, (v) a requested subordination, (vi) evidence concerning any guaranty and/or Guarantor, (vii) any document requested under Paragraph 41, (viii) material data safety sheets (MSDS), or (ix) any other documentation or information which Lessor may reasonably require of Lessee under the terms of this Lease, where any such failure continues for a period of 10 days following written notice to Lessee.

(e) A Default by Lessee as to the terms, covenants, conditions or provisions of this Lease, or of the rules adopted under Paragraph 2.9 hereof, other than those described in subparagraphs 13.1(a), (b) or (c), above, where such Default continues for a period of 30 days after written notice; provided, however, that if the nature of Lessee’s Default is such that more than 30 days are reasonably required for its cure, then it shall not be deemed to be a Breach if Lessee commences such cure within said 30 day period and thereafter diligently prosecutes such cure to completion.

(f) The occurrence of any of the following events: (i) the making of any general arrangement or assignment for the benefit of creditors; (ii) becoming a “debtor” as defined in 11 U.S.C. § 101 or any successor statute thereto (unless, in the case of a petition filed against Lessee, the same is dismissed within 60 days); (iii) the appointment of a trustee or receiver to take possession of substantially all of Lessee’s assets located at the Premises or of Lessee’s interest in this Lease, where possession is not restored to Lessee within 30 days; or (iv) the attachment, execution or other judicial seizure of substantially all of Lessee’s assets located at the Premises or of Lessee’s interest in this Lease, where such seizure is not discharged within 30 days; provided, however, in the event that any provision of this subparagraph is contrary to any applicable law, such provision shall be of no force or effect, and not affect the validity of the remaining provisions.

(g) The discovery that any financial statement of Lessee or of any Guarantor given to Lessor was materially false.

(h) If the performance of Lessee’s obligations under this Lease is guaranteed: (i) the death of a Guarantor, (ii) the termination of a Guarantor’s liability with respect to this Lease other than in accordance with the terms of such guaranty, (iii) a Guarantors becoming insolvent or the subject of a bankruptcy filing, (iv) a Guarantor’s refusal to honor the guaranty, or (v) a Guarantors breach of its guaranty obligation on an anticipatory basis, and Lessee’s failure, within 60 days following written notice of any such event, to provide written alternative assurance or security, which, when coupled with the then existing resources of Lessee, equals or exceeds the combined financial resources of Lessee and the Guarantors that existed at the time of execution of this Lease.

 

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13.2 Remedies., If Lessee fails to perform any of its affirmative duties or obligations, within 10 days after written notice (or in case of an emergency, without notice), Lessor may, at its option, perform such duty or obligation on Lessee’s behalf, including but not limited to the obtaining of reasonably required bonds, insurance policies, or governmental licenses, permits or approvals. Lessee shall pay to Lessor an amount equal to 115% of the costs and expenses incurred by Lessor in such performance upon receipt of an invoice therefor. In the event of a Breach, Lessor may, with or without further notice or demand, and without limiting Lessor in the exercise of any right or remedy which Lessor may have by reason of such Breach:

(a) Terminate Lessee’s right to possession of the Premises by any lawful means, in which case this Lease shall terminate and Lessee shall immediately surrender possession to Lessor. In such event Lessor shall be entitled to recover from Lessee: (i) the unpaid Rent which had been earned at the time of termination; (ii) the worth at the time of award of the amount by which the unpaid rent which would have been earned after termination until the time of award exceeds the amount of such rental loss that the Lessee proves could have been reasonably avoided; (iii) the worth at the time of award of the amount by which the unpaid rent for the balance of the term after the time of award exceeds the amount of such rental loss that the Lessee proves could be reasonably avoided; and (iv) any other amount necessary to compensate Lessor for all the detriment proximately caused by the Lessee’s failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom, including but not limited to the cost of recovering possession of the Premises, expenses of reletting, including necessary renovation and alteration of the Premises, reasonable attorneys’ fees, and that portion of any leasing commission paid by Lessor in connection with this Lease applicable to the unexpired term of this Lease. The worth at the time of award of the amount referred to in provision (iii) of the immediately preceding sentence shall be computed by discounting such amount at the discount rate of the Federal Reserve Bank of the District within which the Premises are located at the time of award plus one percent. Efforts by Lessor to mitigate damages caused by Lessee’s Breach of this Lease shall not waive Lessor’s right to recover damages under Paragraph 12. If termination of this Lease is obtained through the provisional remedy of unlawful detainer, Lessor shall have the right to recover in such proceeding any unpaid Rent and damages as are recoverable therein, or Lessor may reserve the right to recover all or any part thereof in a separate suit. If a notice and grace period required under Paragraph 13.1 was not previously given, a notice to pay rent or quit, or to perform or quit given to Lessee under the unlawful detainer statute shall also constitute the notice required by Paragraph 13.1. In such case , the applicable grace period required by Paragraph 13.1 and the unlawful detainer statute shall run concurrently, and the failure of Lessee to cure the Default within the greater of the two such grace periods shall constitute both an unlawful detainer and a Breach of this Lease entitling Lessor to the remedies provided for in this Lease and/or by said statute.

(b) Continue the Lease and Lessee’s right to possession and recover the Rent as it becomes due, in which event Lessee may sublet or assign, subject only to reasonable limitations. Acts of maintenance, efforts to relet, and/or the appointment of a receiver to protect the Lessor’s interests, shall not constitute a termination of the Lessee’s right to possession.

(c) Pursue any other remedy now or hereafter available under the laws or judicial decisions of the state wherein the Premises are located. The expiration or termination of this Lease and/or the termination of Lessee’s right to possession shall not relieve Lessee from liability under any indemnity provisions of this Lease as to matters occurring or accruing during the term hereof or by reason of Lessee’s occupancy of the Premises.

13.3 Inducement Recapture. Any agreement for free or abated rent or other charges, or for the giving or paying by Lessor to or for Lessee of any cash or other bonus, inducement or consideration for Lessee’s entering into this Lease, all of which concessions are hereinafter referred to as “Inducement Provisions”, shall be deemed conditioned upon Lessee’s full and faithful performance of all of the terms, covenants and conditions of this Lease. Upon Breach of this Lease by Lessee, any such Inducement Provision shall automatically be deemed deleted from this Lease and of no further force or effect, and any rent, other charge, bonus, inducement or consideration theretofore abated, given or paid by Lessor under such an Inducement Provision shall be immediately due and payable by Lessee to Lessor, notwithstanding any subsequent cure of said Breach by Lessee. The acceptance by Lessor of rent or the cure of the Breach which initiated the operation of this paragraph shall not be deemed a waiver by Lessor of the provisions of this paragraph unless specifically so stated in writing by Lessor at the time of such acceptance.

13.4 Late Charges. Lessee hereby acknowledges that late payment by Lessee of Rent will cause Lessor to incur costs not contemplated by this Lease, the exact amount of which will be extremely difficult to ascertain. Such costs include, but are not limited to, processing and accounting charges, and late charges which may be imposed upon Lessor by any Lender. Accordingly, if any Rent shall not be received by Lessor within 5 days after such amount shall be due, then, without any requirement for notice to Lessee, Lessee shall immediately pay to Lessor a one-time late charge equal to 10% of each such overdue amount or $100, whichever is greater. The parties hereby agree that such late charge represents a fair and reasonable estimate of the costs Lessor will incur by reason of such late payment. Acceptance of such late charge by Lessor shall in no event constitute a waiver of Lessee’s Default or Breach with respect to such overdue amount, nor prevent the exercise of any of the other rights and remedies granted hereunder. In the event that a late charge is payable hereunder, whether or not collected, for 3 consecutive installments of Base Rent, then notwithstanding any provision of this Lease to the contrary, Base Rent shall, at Lessor’s option, become due and payable quarterly in advance.

13.5 Interest. Any monetary payment due Lessor hereunder, other than late charges, not received by Lessor, when due as to scheduled payments (such as Base Rent) or within 30 days following the date on which it was due for nonscheduled payment, shall bear interest from the date when due, as to scheduled payments, or the 31st day after it was due as to nonscheduled payments. The interest (“Interest”) charged shall be computed at the rate of 10% per annum but shall not exceed the maximum rate allowed by law. Interest is payable in addition to the potential late charge provided for in Paragraph 13.4.

13.6 Breach by Lessor.

(a) Notice of Breach. Lessor shall not be deemed in breach of this Lease unless Lessor fails within a reasonable time to perform an obligation required to be performed by Lessor. For purposes of this Paragraph, a reasonable time shall in no event be less than 30 days after receipt by Lessor, and any Lender whose name and address shall have been furnished Lessee in writing for such purpose, of written notice specifying wherein such obligation of Lessor has not been performed; provided, however, that if the nature of Lessor’s obligation is such that more than 30 days are reasonably required for its performance, then Lessor shall not be in breach if performance is commenced within such 30 day period and thereafter diligently pursued to completion.

(b) Performance by Lessee on Behalf of Lessor. In the event that neither Lessor nor Lender cures said breach within 30 days after receipt of said notice, or if having commenced said cure they do not diligently pursue it to completion, then Lessee may deliver an additional written notice to Lessor and Lender that Lessee intends to cure said breach at Lessor’s expense if Lessor or Lender fail to commence to cure such breach within five (5) business days following their respective receipt of such additional notice. If Lessee delivers said additional notice and neither Lessor nor Lender cures said breach, or if having commenced to cure they do not diligently pursue it to completion, within such additional five (5) day period, then Lessee may elect to cure said breach at Lessee’s expense and offset from Rent the actual and reasonable cost to perform such cure, provided however , that such offset shall not exceed an amount equal to the greater of one month’s Base Rent or the Security Deposit, reserving Lessee’s right to seek reimbursement from Lessor for any such expense in excess of such offset. Lessee shall document the cost of said cure and supply said documentation to Lessor. Lessee’s sole remedy for a breach by Lessor shall be to cure the breach as provided in this Paragraph 13.6(b) and Lessee shall have no right to terminate the Lease by reason thereof.

14. Condemnation. If the Premises or any portion thereof are taken under the power of eminent domain or sold under the threat of the exercise of said power (collectively “Condemnation”), this Lease shall terminate as to the part taken as of the date the condemning authority takes title or possession, whichever first occurs. If more than 10% of the rentable floor area of the Premises, or more than 25% of Lessee’s Reserved Parking Spaces, if any, are taken by Condemnation, Lessee may, at Lessee’s option, to be exercised in writing within 10 days after Lessor shall have given Lessee written notice of such taking (or in the absence of such notice, within 10 days after the condemning authority shall have taken possession) terminate this Lease as of the date the condemning authority takes such possession. If Lessee does not terminate this Lease in accordance with the foregoing, this Lease shall remain in full force and effect as to the portion of the Premises remaining, except that the Base Rent shall be reduced in proportion to the reduction in utility of the Premises caused by such Condemnation. Condemnation awards and/or payments shall be the property of Lessor, whether such award shall be made as compensation for diminution in value of the leasehold, the value of the part taken, or for severance damages; provided, however, that Lessee shall be entitled to any compensation paid by the condemnor for Lessee’s relocation expenses, loss of business goodwill and/or Trade Fixtures, without regard to whether or not this Lease is terminated pursuant to the provisions of this Paragraph. All Alterations and Utility Installations made to the Premises by Lessee, for purposes of Condemnation only, shall be considered the property of the Lessee and Lessee shall be entitled to any and all compensation which is payable therefor. In the event that this Lease is not terminated by reason of the Condemnation, Lessor shall repair any damage to the Premises caused by such Condemnation.

15. Brokerage Fees.

15.1 Additional Commission. If a separate brokerage fee agreement is attached then in addition to the payments owed pursuant to Paragraph 1.10 above, and unless Lesser and the Brokers otherwise agree in writing, Lessor agrees that: (a) if Lessee exercises any Option, (b) if Lessee or anyone affiliated with Lessee acquires from Lesser any rights to the Promises or other promises owned by Lessor and located within the Project, (c) if Lessee remains in possession of the Premises, with the consent of Lesser, after the expiration of this Lease, or (d) if Base Rent is increased, whether by agreement or operation of an escalation clause herein, then, Lesser shall pay Brokers a fee in accordance with the schedule attached to such brokerage fee agreement.

15.2 Assumption of Obligations. Any buyer or transferee of Lesser’s interest in this Lease shall be deemed to have assumed Lesser’s obligation hereunder. Brokers shall be third party beneficiaries of the provisions of Paragraphs 1.10, 15, 22 and 31. If Lessor fails to pay to Brokers any amounts due as and for brokerage fees pertaining to this Lease when due, then such amounts shall accrue Interest. In addition, if Lesser fails to pay any amounts to Lessee’s Broker when due, Lessee’s Broker may send written notice to Lessor and Lessee of such failure and if Lessor fails to pay such amounts within 10 days after said notice, Lessee, shall pay said monies to its Broker and offset such amounts against Rent. In addition, Lessee’s Broker shall be deemed to be a third party beneficiary of any commission agreement entered into by and/or between Lesser and Lessor’s Broker for the limited purpose of collecting any brokerage fee owed.

 

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15.3 Representations and Indemnities of Broker Relationships. Lessee and Lessor each represent and warrant to the other that it has had no dealings with any person, firm, broker or finder (other than the Brokers, if any) in connection with this Lease, and that no one other than said named Brokers is entitled to any commission or finder’s fee in connection herewith. Lessee and Lessor do each hereby agree to indemnify, protect, defend and hold the other harmless from and against liability for compensation or charges which may be claimed by any such unnamed broker, finder or other similar party by reason of any dealings or actions of the indemnifying Party, including any costs, expenses, attorneys’ fees reasonably incurred with respect thereto.

16. Estoppel Certificates.

(a) Each Party (as “Responding Party”) shall within 10 days after written notice from the other Party (the “Requesting Party”) execute, acknowledge and deliver to the Requesting Party a statement in writing in form similar to the then most current “Estoppel Certificate” form published by the AIRCommercial Real Estate Association, plus such additional information, confirmation and/or statements as may be reasonably requested by the Requesting Party.

(b) If the Responding Party shall fail to execute or deliver the Estoppel Certificate within such 10 day period, the Requesting Party may execute an Estoppel Certificate stating that: (i) the Lease is in full force and effect without modification except as may be represented by the Requesting Party, (ii) there are no uncured defaults in the Requesting Party’s performance, and (iii) if Lessor is the Requesting Party, not more than one month’s rent has been paid in advance. Prospective purchasers and encumbrancers may rely upon the Requesting Party’s Estoppel Certificate, and the Responding Party shall be estopped from denying the truth of the facts contained in said Certificate.

(c) If Lessor desires to finance, refinance, or sell the Premises, or any part thereof, Lessee and all Guarantors shall within 10 days after written notice from Lessor deliver to any potential lender or purchaser designated by Lessor such financial statements as may be reasonably required by such lender or purchaser, including but not limited to Lessee’s financial statements for the past 3 years. All such financial statements shall be received by Lessor and such lender or purchaser in confidence and shall be used only for the purposes herein set forth.

17. Definition of Lessor. The term “Lessor” as used herein shall mean the owner or owners at the time in question of the fee title to the Premises, or, if this is a sublease, of the Lessee’s interest in the prior lease. In the event of a transfer of Lessor’s title or interest in the Premises or this Lease, Lessor shall deliver to the transferee or assignee (in cash or by credit) any unused Security Deposit held by Lessor. Upon such transfer or assignment and delivery of the Security Deposit, as aforesaid, the prior Lessor shall be relieved of all liability with respect to the obligations and/or covenants under this Lease thereafter to be performed by the Lessor. Subject to the foregoing, the obligations and/or covenants in this Lease to be performed by the Lessor shall be binding only upon the Lessor as hereinabove defined.

18. Severability. The invalidity of any provision of this Lease, as determined by a court of competent jurisdiction, shall in no way affect the validity of any other provision hereof.

19. Days. Unless otherwise specifically indicated to the contrary, the word “days” as used in this Lease shall mean and refer to calendar days.

20. Limitation on Liability. The obligations of Lessor under this Lease shall not constitute personal obligations of Lessor or its partners, members, directors, officers or shareholders, and Lessee shall look to the Project, and to no other assets of Lessor, for the satisfaction of any liability of Lessor with respect to this Lease, and shall not seek recourse against Lessor’s partners, members, directors, officers or shareholders, or any of their personal assets for such satisfaction. For purposes of determining the value of lessor’s interest in the Premises, the Project shall be deemed to be encumbered by a loan amount equal to seventy percent (70%) of the fair market value of the Project, as determined as of the date lessee’s claim arises.

21. Time of Essence. Time is of the essence with respect to the performance of all obligations to be performed or observed by the Parties under this Lease.

22. No Prior or Other Agreements; Broker Disclaimer. This Lease contains all agreements between the Parties with respect to any matter mentioned herein, and no other prior or contemporaneous agreement or understanding shall be effective. Lesser and Lessee each represents and warrants to the Brokers that it has made, and is relying solely upon, its own investigation as to the nature, quality, character and financial responsibility of the other Party to this Lease and as to the use, nature, quality and character of the Promises. Brokers have no responsibility with respect thereto or with respect to any default or broach hereof by either Party.

23. Notices.

23.1 Notice Requirements. All notices required or permitted by this Lease or applicable law shall be in writing and may be delivered in person (by hand or by courier) or may be sent by regular, certified or registered mail or U.S. Postal Service Express Mail, with postage prepaid, or by facsimile transmission, and shall be deemed sufficiently given if served in a manner specified in this Paragraph 23. The addresses noted adjacent to a Party’s signature on this Lease shall be that Party’s address for delivery or mailing of notices. Either Party may by written notice to the other specify a different address for notice, except that upon Lessee’s taking possession of the Premises, the Premises shall constitute Lessee’s address for notice. A copy of all notices to Lessor shall be concurrently transmitted to such party or parties at such addresses as Lessor may from time to time hereafter designate in writing.

23.2 Date of Notice. Any notice sent by registered or certified mail, return receipt requested, shall be deemed given on the date of delivery shown on the receipt card, or if no delivery date is shown, the postmark thereon. If sent by regular mail the notice shall be deemed given 72 hours after the same is addressed as required herein and mailed with postage prepaid. Notices delivered by United States Express Mail or overnight courier that guarantees next day delivery shall be deemed given 24 hours after delivery of the same to the Postal Service or courier. Notices transmitted by facsimile transmission or similar means shall be deemed delivered upon telephone confirmation of receipt (confirmation report from fax machine is sufficient), provided a copy is also delivered via delivery or mail. If notice is received on a Saturday, Sunday or legal holiday, it shall be deemed received on the next business day.

24. Waivers.

(a) No waiver by Lessor of the Default or Breach of any term, covenant or condition hereof by Lessee, shall be deemed a waiver of any other term, covenant or condition hereof, or of any subsequent Default or Breach by Lessee of the same or of any other term, covenant or condition hereof. Lessor’s consent to, or approval of, any act shall not be deemed to render unnecessary the obtaining of Lessor’s consent to, or approval of, any subsequent or similar act by Lessee, or be construed as the basis of an estoppel to enforce the provision or provisions of this Lease requiring such consent.

(b) The acceptance of Rent by Lessor shall not be a waiver of any Default or Breach by Lessee. Any payment by Lessee may be accepted by Lessor on account of moneys or damages due Lessor, notwithstanding any qualifying statements or conditions made by Lessee in connection therewith, which such statements and/or conditions shall be of no force or effect whatsoever unless specifically agreed to in writing by Lessor at or before the time of deposit of such payment.

(c) THE PARTIES AGREE THAT THE TERMS OF THIS LEASE SHALL GOVERN WITH REGARD TO ALL MATTERS RELATED THERETO AND HEREBY WAIVE THE PROVISIONS OF ANY PRESENT OR FUTURE STATUTE TO THE EXTENT THAT SUCH STATUTE IS INCONSISTENT WITH THIS LEASE.

25. Disclosures Regarding The Nature of a Real Estate Agency Relationship.

(a) When entering into a discussion with a real estate agent regarding a real estate transaction, a Lessor or Lessee should from the outset understand what type of agency relationship or representation it has with the agent or agents in the transaction. Lessor and Lessee acknowledge being advised by the Brokers in this transaction, as follows:

(i) Lessor’s Agent. A Lessor’s agent under a listing agreement with the Lessor acts as the agent for the Lessor only. A Lessor’s agent or subagent has the following affirmative obligations: To the Lessor: A fiduciary duty of utmost care, integrity, honesty, and loyalty in dealings with the Lessor. To the Lessee and the Lessor: a. Diligent exercise of reasonable skills and care in performance of the agent’s duties. b. A duty of honest and fair dealing and good faith, c. A duty to disclose all facts known to the agent materially affecting the value or desirability of the property that are not known to, or within the diligent attention and observation of, the Parties. An agent is not obligated to reveal to either Party any confidential information obtained from the other Party which does not involve the affirmative duties set forth above.

(ii) Lessee’s Agent. An agent can agree to act as agent for the Lessee only. In these situations, the agent is not the Lessor’s agent, even if by agreement the agent may receive compensation for services rendered, either in full or in part from the Lessor. An agent acting only for a Lessee has the following affirmative obligations. To the Lessee: A fiduciary duty of utmost care, integrity, honesty, and loyalty in dealings with the Lessee. To the Lessee and the Lessor: a. Diligent exercise of reasonable skills and care in performance of the agent’s duties. b. A duty of honest and fair dealing and good faith.,c. A duty to disclose all facts known to the agent materially affecting the value or desirability of the property that are not known to, or within the diligent attention and observation of, the Parties. An agent is not obligated to reveal to either Party any confidential information obtained from the other Party which does not involve the affirmative duties set forth above.

(iii) Agent Representing Both Lessor and Lessee. A real estate agent, either acting directly or through one or more associate licenses, can legally be the agent of both the Lessor and the Lessee in a transaction, but only with the knowledge and consent of both the Lessor and the Lessee. In a dual agency situation, the agent has the following affirmative obligations to both the Lessor and the Lessee: a. A fiduciary duty of utmost care, integrity, honesty and loyalty in the dealings with either Lesser or the Lessee. b. Other duties to the Lessor and the Lessee as stated above in subparagraphs (i) or (ii). In representing both Lessor and Lessee, the agent may not without the express permission of the respective Party, disclose to the other Party that the Lessor will accept rent in an amount less than that indicated in the listing or that the Lessee is willing to pay a

 

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higher rent than that offered. The above duties of the agent in a real estate transaction do not relieve a Lessor or Lessee from the responsibility to protect their own interests. Lessor and Lessee should carefully read all agreements to assure that they adequately express their understanding of the transaction. A real estate agent is a person qualified to advise about real estate. If legal or tax advise is desired, consult a competent professional.

(b) Brokers have no responsibility with respect to any default or broach hereof by either Party. The Parties agree that no lawsuit or other legal proceeding involving any broach of duty, error or omission relating to this Lease may be brought against Broker more than one year after the Start Date and that the liability (including court costs and attorneys’ fees), of any Broker with respect to any such lawsuit and/or legal proceeding shall not exceed the fee received by ouch Broker pursuant to this Lease; provided, however, that the foregoing limitation on each Broker’s liability shall not be applicable to any gross negligence or willful misconduct of such Broker.

(c) Lessor and Lessee agree to identify to Brokers as “Confidential” any communication or information given Brokers that is considered by such Party to be confidential.

26. No Right To Holdover. Lessee has no right to retain possession of the Premises or any part thereof beyond the expiration or termination of this Lease. In the event that Lessee holds over, then the Base Rent shall be increased to 150% of the Base Rent applicable immediately preceding the expiration or termination. Nothing contained herein shall be construed as consent by Lessor to any holding over by Lessee.

27. Cumulative Remedies. No remedy or election hereunder shall be deemed exclusive but shall, wherever possible, be cumulative with all other remedies at law or in equity.

28. Covenants and Conditions; Construction of Agreement. All provisions of this Lease to be observed or performed by Lessee are both covenants and conditions. In construing this Lease, all headings and titles are for the convenience of the Parties only and shall not be considered a part of this Lease. Whenever required by the context, the singular shall include the plural and vice versa. This Lease shall not be construed as if prepared by one of the Parties, but rather according to its fair meaning as a whole, as if both Parties had prepared it.

29. Binding Effect; Choice of Law. This Lease shall be binding upon the Parties, their personal representatives, successors and assigns and be governed by the laws of the State in which the Premises are located. Any litigation between the Parties hereto concerning this Lease shall be initiated in the county in which the Premises are located.

30. Subordination; Attornment; Non-Disturbance.

30.1 Subordination. This Lease and any Option granted hereby shall be subject and subordinate to any ground lease, mortgage, deed of trust, or other hypothecation or security device (collectively, “Security Device”), now or hereafter placed upon the Premises, to any and all advances made on the security thereof, and to all renewals, modifications, and extensions thereof. Lessee agrees that the holders of any such Security Devices (in this Lease together referred to as “Lender”) shall have no liability or obligation to perform any of the obligations of Lessor under this Lease. Any Lender may elect to have this Lease and/or any Option granted hereby superior to the lien of its Security Device by giving written notice thereof to Lessee, whereupon this Lease and such Options shall be deemed prior to such Security Device, notwithstanding the relative dates of the documentation or recordation thereof.

30.2 Attornment. In the event that Lessor transfers title to the Premises, or the Premises are acquired by another upon the foreclosure or termination of a Security Devise to which this Lease is subordinated (i) Lessee shall, subject to the non-disturbance provisions of Paragraph 30.3, attorn to such new owner, and upon request, enter into a new lease, containing all of the terms and provisions of this Lease, with such new owner for the remainder of the term hereof, or, at the election of the new owner, this Lease will automatically become a new lease between Lessee and such new owner, and (ii) Lessor shall thereafter be relieved of any further obligations hereunder and such new owner shall assume all of Lessor’s obligations, except that such new owner shall not: (a) be liable for any act or omission of any prior lessor or with respect to events occurring prior to acquisition of ownership; (b) be subject to any offsets or defenses which Lessee might have against any prior lessor, (c) be bound by prepayment of more than one month’s rent, or (d) be liable for the return of any security deposit paid to any prior lessor which was not paid or credited to such new owner.

30.3 Non-Disturbance. With respect to Security Devices entered into by Lessor after the execution of this Lease, Lessee’s subordination of this Lease shall be subject to receiving a commercially reasonable non-disturbance agreement (a “Non-Disturbance Agreement”) from the Lender which Non-Disturbance Agreement provides that Lessee’s possession of the Premises, and this Lease, including any options to extend the term hereof, will not be disturbed so long as Lessee is not in Breach hereof and attorns to the record owner of the Premises. Further, within 60 days after the execution of this Lease, Lessor shall, if requested by Lessee, use its commercially reasonable efforts to obtain a Non-Disturbance Agreement from the holder of any pre-existing Security Device which is secured by the Premises. In the event that Lessor is unable to provide the Non-Disturbance Agreement within said 60 days, then Lessee may, at Lessee’s option, directly contact Lender and attempt to negotiate for the execution and delivery of a Non-Disturbance Agreement.

30.4 Self-Executing. The agreements contained in this Paragraph 30 shall be effective without the execution of any further documents; provided, however, that, upon written request from Lessor or a Lender in connection with a sale, financing or refinancing of the Premises, Lessee and Lessor shall execute such further writings as may be reasonably required to separately document any subordination, attornment and/or Non-Disturbance Agreement provided for herein.

31. Attorneys’ Fees. If any Party or Broker brings an action or proceeding involving the Premises whether founded in tort, contract or equity, or to declare rights hereunder, the Prevailing Party (as hereafter defined) in any such proceeding, action, or appeal thereon, shall be entitled to reasonable attorneys’ fees. Such fees may be awarded in the same suit or recovered in a separate suit, whether or not such action or proceeding is pursued to decision or judgment. The term, “Prevailing Party” shall include, without limitation, a Party or Broker who substantially obtains or defeats the relief sought, as the case may be, whether by compromise, settlement, judgment, or the abandonment by the other Party or Broker of its claim or defense. The attorneys’ fees award shall not be computed in accordance with any court fee schedule, but shall be such as to fully reimburse all attorneys’ fees reasonably incurred. In addition, Lessor shall be entitled to attorneys’ fees, costs and expenses incurred in the preparation and service of notices of Default and consultations in connection therewith, whether or not a legal action is subsequently commenced in connection with such Default or resulting Breach ($200 is a reasonable minimum per occurrence for such services and consultation).

32. Lessor’s Access; Showing Premises; Repairs. Lessor and Lessor’s agents shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times after reasonable prior notice for the purpose of showing the same to prospective purchasers, lenders, or tenants, and making such alterations, repairs, improvements or additions to the Premises as Lessor may deem necessary or desirable and the erecting, using and maintaining of utilities, services, pipes and conduits through the Premises and/or other premises as long as there is no material adverse effect on Lessee’s use of the Premises. All such activities shall be without abatement of rent or liability to Lessee.

33. Auctions. Lessee shall not conduct, nor permit to be conducted, any auction upon the Premises without Lessor’s prior written consent. Lessor shall not be obligated to exercise any standard of reasonableness in determining whether to permit an auction.

34. Signs: Publicity. Lessor may place on the Premises ordinary “For Sale” signs at any time and ordinary “For Lease” signs during the last 6 months of the term hereof. Lessor may not place any sign on the exterior of the Building that covers any of the windows of the Premises. Except for ordinary “For Sublease” signs which may be placed only on the Premises. Lessee shall not place any sign upon the Project without Lessor’s prior written consent. All signs must comply with all Applicable Requirements. Lessor shall have the right to publicize Lessor and Lessee’s relationship regarding this Lease.

35. Termination; Merger. Unless specifically stated otherwise in writing by Lessor, the voluntary or other surrender of this Lease by Lessee, the mutual termination or cancellation hereof, or a termination hereof by Lessor for Breach by Lessee, shall automatically terminate any sublease or lesser estate in the Premises; provided, however, that Lessor may elect to continue any one or all existing subtenancies. Lessor’s failure within 10 days following any such event to elect to the contrary by written notice to the holder of any such lesser interest, shall constitute Lessor’s election to have such event constitute the termination of such interest.

36. Consents. Except as otherwise provided herein, wherever in this Lease the consent of a Party is required to an act by or for the other Party, such consent shall not be unreasonably withheld or delayed. Lessor’s actual reasonable costs and expenses (including but not limited to architects’, attorneys’, engineers’ and other consultants’ fees) incurred in the consideration of, or response to, a request by Lessee for any Lessor consent, including but not limited to consents to an assignment, a subletting or the presence or use of a Hazardous Substance, shall be paid by Lessee upon receipt of an invoice and supporting documentation therefor. Lessor’s consent to any act, assignment or subletting shall not constitute an acknowledgment that no Default or Breach by Lessee of this Lease exists, nor shall such consent be deemed a waiver of any then existing Default or Breach, except as may be otherwise specifically stated in writing by Lessor at the time of such consent. The failure to specify herein any particular condition to Lessor’s consent shall not preclude the imposition by Lessor at the time of consent of such further or other conditions as are then reasonable with reference to the particular matter for which consent is being given. In the event that either Party disagrees with any determination made by the other hereunder and reasonably requests the reasons for such determination, the determining party shall furnish its reasons in writing and in reasonable detail within 10 business days following such request.

37. Guarantor.

37.1 Execution. The Guarantors, if any, shall each execute a guaranty in the form most recently published by the AIR Commercial Real Estate Association.

37.2 Default. It shall constitute a Default of the Lessee if any Guarantor fails or refuses, upon request to provide: (a) evidence of the execution of the guaranty, including the authority of the party signing on Guarantor’s behalf to obligate Guarantor, and in the case of a corporate Guarantor, a certified copy of a resolution of its board of directors authorizing the making of such guaranty, (b) current financial statements, (c) an Estoppel Certificate or (d) written confirmation that the guaranty is still in effect.

 

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38. Quiet Possession. Subject to payment by Lessee of the Rent and performance of all of the covenants, conditions and provisions on Lessee’s part to be observed and performed under this Lease, Lessee shall have quiet possession and quiet enjoyment of the Premises during the term hereof.

39. Options. If Lessee is granted an Option as defined below, then the following provisions shall apply.

39.1 Definition. “Option” shall mean: (a) the right to extend or reduce the term of or renew this Lease or to extend or reduce the term of or renew any lease that Lessee has on other property of Lessor; (b) the right of first refusal or first offer to lease either the Premises or other property of Lessor; (c) the right to purchase, the right of first offer to purchase or the right of first refusal to purchase the Premises or other property of Lessor.

39.2 Options Personal To Original Lessee. Any Option granted to Lessee in this Lease is personal to the original Lessee, and cannot be assigned or exercised by anyone other than said original Lessee and only while the original Lessee is in full possession of the Premises and, if requested by Lessor, with Lessee certifying that Lessee has no intention of thereafter assigning or subletting.

39.3 Multiple Options. In the event that Lessee has any multiple Options to extend or renew this Lease, a later Option cannot be exercised unless the prior Options have been validly exercised.

39.4 Effect of Default on Options.

(a) Lessee shall have no right to exercise an Option: (i) during the period commencing with the giving of any notice of Default and continuing until said Default is cured, (ii) during the period of time any Rent is unpaid (without regard to whether notice thereof is given Lessee), (iii) during the time Lessee is in Breach of this Lease, or (iv) in the event that Lessee has been given 3 or more notices of separate Default, whether or not the Defaults are cured, during the 12 month period immediately preceding the exercise of the Option.

(b) The period of time within which an Option may be exercised shall not be extended or enlarged by reason of Lessee’s inability to exercise an Option because of the provisions of Paragraph 39.4(a).

(c) An Option shall terminate and be of no further force or effect, notwithstanding Lessee’s due and timely exercise of the Option, if, after such exercise and prior to the commencement of the extended term or completion of the purchase, (i) Lessee fails to pay Rent for a period of 30 days after such Rent becomes due (without any necessity of Lessor to give notice thereof), or (ii) if Lessee commits a Breach of this Lease.

40. Security Measures. Lessee hereby acknowledges that the Rent payable to Lessor hereunder does not include the cost of guard service or other security measures, and that Lessor shall have no obligation whatsoever to provide same. Lessee assumes all responsibility for the protection of the Premises, Lessee, its agents and invitees and their property from the acts of third parties. In the event, however, that Lessor should elect to provide security services, then the cost thereof shall be an Operating Expense.

41. Reservations.

(a) Lessor reserves the right: (i) to grant, without the consent or joinder of Lessee, such easements, rights and dedications that Lessor deems necessary, (ii) to cause the recordation of parcel maps and restrictions, (iii) to create and/or install new utility raceways, so long as such easements, rights, dedications, maps, restrictions, and utility raceways do not unreasonably interfere with the use of the Premises by Lessee. Lessor may also: change the name, address or title of the Building or Project upon at least 90 days prior written notice; provide and install, at Lessee’s expense. Building standard graphics on the door of the Premises and such portions of the Common Areas as Lessor shall reasonably deem appropriate; grant to any lessee the exclusive right to conduct any business as long as such exclusive right does not conflict with any rights expressly given herein; and to place such signs, notices or displays as Lessor reasonably deems necessary or advisable upon the roof, exterior of the Building or the Project or on signs in the Common Areas. Lessee agrees to sign any documents reasonably requested by Lessor to effectuate such rights. The obstruction of Lessee’s view, air, or light by any structure erected in the vicinity of the Building, whether by Lessor or third parties, shall in no way affect this Lease or impose any liability upon Lessor.

(b) Lessor also reserves the right to move Lessee to other space of comparable size in the Building or Project. Lessor must provide at least 45 days prior written notice of such move, and the new space must contain improvements of comparable quality to those contained within the Premises. Lessor shall pay the reasonable out of pocket costs that Lessee incurs with regard to such relocation, including the expenses of moving and necessary stationary revision costs. In no event, however, shall Lessor be required to pay an amount in excess of two months Base Rent. Lessee may not be relocated more than once during the term of this Lease.

(c) Lessee shall not: (i) use a representation (photographic or otherwise) of the Building or Project or their name(s) in connection with Lessee’s business; or (ii) suffer or permit anyone, except in emergency, to go upon the roof of the Building.

42. Performance Under Protest. If at any time a dispute shall arise as to any amount or sum of money to be paid by one Party to the other under the provisions hereof, the Party against whom the obligation to pay the money is asserted shall have the right to make payment “under protest” and such payment shall not be regarded as a voluntary payment and there shall survive the right on the part of said Party to institute suit for recovery of such sum. If it shall be adjudged that there was no legal obligation on the part of said Party to pay such sum or any part thereof, said Party shall be entitled to recover such sum or so much thereof as it was not legally required to pay. A Party who does not initiate suit for the recovery of sums paid “under protest” within 6 months shall be deemed to have waived its right to protest such payment.

43. Authority; Multiple Parties; Execution

(a) If either Party hereto is a corporation, trust, limited liability company, partnership, or similar entity, each individual executing this Lease on behalf of such entity represents and warrants that he or she is duly authorized to execute and deliver this Lease on its behalf. Each Party shall, within 30 days after request, deliver to the other Party satisfactory evidence of such authority.

(b) If this Lease is executed by more than one person or entity as “Lessee”, each such person or entity shall be jointly and severally liable hereunder. It is agreed that any one of the named Lessees shall be empowered to execute any amendment to this Lease, or other document ancillary thereto and bind all of the named Lessees, and Lessor may rely on the same as if all of the named Lessees had executed such document.

(c) This Lease may be executed by the Parties in counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument.

44. Conflict. Any conflict between the printed provisions of this Lease and the typewritten or handwritten provisions shall be controlled by the typewritten or handwritten provisions.

45. Offer. Preparation of this Lease by either party or their agent and submission of same to the other Party shall not be deemed an offer to lease to the other Party. This Lease is not intended to be binding until executed and delivered by all Parties hereto.

46. Amendments. This Lease may be modified only in writing, signed by the Parties in interest at the time of the modification. As long as they do not materially change Lessee’s obligations hereunder, Lessee agrees to make such reasonable non monetary modifications to this Lease as may be reasonably required by a Lender in connection with the obtaining of normal financing or refinancing of the Premises.

47. Waiver of Jury Trial. THE PARTIES HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING INVOLVING THE PROPERTY OR ARISING OUT OF THIS AGREEMENT.

48. Arbitration of Disputes. An Addendum requiring the Arbitration of all disputes between the Parties and/or Brokers arising out of this Lease ☑ is ☐ is not attached to this Lease.

49. Americans with Disabilities Act. Since compliance with the Americans with Disabilities Act (ADA) is dependent upon Lessee’s specific use of the Premises, Lessor makes no warranty or representation as to whether or not the Premises comply with ADA or any similar legislation. In the event that Lessee’s use of the Premises requires modifications or additions to the Premises in order to be in ADA compliance. Lessee agrees to make any such necessary modifications and/or additions at Lessee’s expense.

LESSOR AND LESSEE HAVE CAREFULLY READ AND REVIEWED THIS LEASE AND EACH TERM AND PROVISION CONTAINED HEREIN, AND BY THE EXECUTION OF THIS LEASE SHOW THEIR INFORMED AND VOLUNTARY CONSENT THERETO. THE PARTIES HEREBY AGREE THAT, AT THE TIME THIS LEASE IS EXECUTED, THE TERMS OF THIS LEASE ARE COMMERCIALLY REASONABLE AND EFFECTUATE THE INTENT AND PURPOSE OF LESSOR AND LESSEE WITH RESPECT TO THE PREMISES.

ATTENTION: NO REPRESENTATION OR RECOMMENDATION IS MADE BY THE AIR COMMERCIAL REAL ESTATE ASSOCIATION OR BY ANY BROKER AS TO THE LEGAL SUFFICIENCY, LEGAL EFFECT, OR TAX CONSEQUENCES OF THIS LEASE OR THE TRANSACTION TO WHICH IT RELATES. THE PARTIES ARE URGED TO:

1. SEEK ADVICE OF COUNSEL AS TO THE LEGAL AND TAX CONSEQUENCES OF THIS LEASE.

 

©1999 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM OFG-9-3/10E

PAGE 13 OF 14


2. RETAIN APPROPRIATE CONSULTANTS TO REVIEW AND INVESTIGATE THE CONDITION OF THE PREMISES. SAID INVESTIGATION SHOULD INCLUDE BUT NOT BE LIMITED TO: THE POSSIBLE PRESENCE OF HAZARDOUS SUBSTANCES, THE ZONING AND SIZE OF THE PREMISES, THE STRUCTURAL INTEGRITY, THE CONDITION OF THE ROOF AND OPERATING SYSTEMS, COMPLIANCE WITH THE AMERICANS WITH DISABILITIES ACT AND THE SUITABILITY OF THE PREMISES FOR LESSEE’S INTENDED USE.

WARNING: IF THE PREMISES ARE LOCATED IN A STATE OTHER THAN CALIFORNIA, CERTAIN PROVISIONS OF THE LEASE MAY NEED TO BE REVISED TO COMPLY WITH THE LAWS OF THE STATE IN WHICH THE PREMISES ARE LOCATED.

The parties hereto have executed this Lease at the place and on the dates specified above their respective signatures.

Executed at:         LA, CA                                                 Executed at:                                                                               
On:         10-25-16                                             On:                                                                                               
By LESSOR:    By LESSEE:
RIF III – Avenue Stanford, LLC, a California limited liability company    Avita Medical Americas, LLC, a Delaware limited liability company

 

By: Rexford Industrial Realty, L.P., a Maryland limited

partnership, its Managing Member

  

By: Rexford Industrial Realty, Inc., a Maryland

corporation, its General Partner

  

By: /s/ Howard Schwimmer                                             

  

By: /s/ Troy Barring                                                                 

Name Printed: Howard Schwimmer

  

Name Printed: Troy Barring

Title: Co-Chief Executive Officer

  

Title: Chief Operating Officer

 

By:         By:    
Name Printed:         Name Printed:    
Title:         Title:    
Address: 11620 Wilshire Blvd, Suite 1000     Address:    
Los Angeles, CA 90025        
Telephone:(310) 966-1680     Telephone: (      )    
Facsimile:(310) 966-1690     Facsimile: (      )    
Email:         Email:    
Email:         Email:    
Federal ID No.         Federal ID No.    

 

LESSOR’S BROKER:    

LESSEE’S BROKER:

CBRE, Inc.     CBRE, Inc.
Attn: Craig Peters     Attn: Richard Ramirez
Address: 234 S. Brand Blvd., Suite 800 Glendale, CA 91204     Address: 234 S. Brand Blvd., Suite 800 Glendale, CA 91204

Telephone: (818) 907-4639

Facsimile: (818) 907-4702

   

Telephone: (818)907-4639

Facsimile: (818) 907-4702

Email: richard.ramirez@cbre.com     Email: richard.ramirez@cbre.com
Broker/Agent DRE License #: 00409987/00906542     Broker/Agent DRE License #: 00409987/01792270

NOTICE: These forms are often modified to meet changing requirements of law and industry needs. Always write or call to make sure you are utilizing the most current form: AIR Commercial Real Estate Association, 800 W 6th Street, Suite 800, Los Angeles, CA 90017. Telephone No. (213) 687-8777. Fax No.: (213) 687-8616.

©Copyright 1999-By AIR Commercial Real Estate Association.

All rights reserved.

No part of these works may be reproduced in any form without permission in writing.

 

©1999 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM OFG-9-3/10E

PAGE 14 OF 14


ADDENDUM TO STANDARD INDUSTRIAL/COMMERCIAL

MULTI-TENANT LEASE—GROSS

AVITA MEDICAL AMERICAS, LLC

28159 AVENUE STANFORD, UNIT 220, VALENCIA, CA 91355

This Addendum to the Standard Multi-Tenant Office Lease—Gross (this “Addendum”) is entered into by and between RIF III – Avenue Stanford, LLC, a California Limited Liability Company (“Lessor”), and Avita Medical Americas, LLC, a Delaware limited liability company (“Lessee”), as of the date set forth in the first page of the form Lease to which this Addendum is attached (the “Form Lease”). The promises, covenants, agreements and declarations made and set forth herein are intended to and shall have the same force and effect as if set forth in the body of the Form Lease. To the extent that the provisions of this Addendum are inconsistent with the terms and conditions of the Form Lease, the provisions of this Addendum shall control. Except for purposes of determining whether a conflict exists between the Form Lease and this Addendum, the term “Lease” (as used herein and in the Form Lease) shall include the provisions of this Addendum.

1.2 Premises (continued). The parties acknowledge that Paragraph 1.2(a) of the Form Lease contains Lessor’s best estimate of what the rentable square footage of the Premises will be upon delivery of possession after the completion of the Lessor Improvements (as defined in Paragraph 52 below). Lessor shall notify Lessee of the actual rentable area of the Premises calculated in conformity with the BOMA Standard, and the rentable footage of the Premises contained in this Lease shall be modified accordingly unless Lessee contests Lessor’s measurement or application of the BOMA Standard (in which case Lessor and Lessee shall promptly appoint a mutually acceptable party to re-measure the Premises in accordance with the BOMA Standard, and such party’s determination shall be binding on Lessor and Lessee). In the event that the rentable square footage of the Premises, measured in conformity with the BOMA Standard, differs from the square footage set forth in Paragraph 1.2(a) of the Form Lease, then the Base Rent (Paragraph 1.5), Lessee’s Share of Common Area Operating Expenses (Paragraph 1.6), and the Security Deposit (Paragraph 1.7) shall be recalculated to reflect any changes from the rentable square footage of the Premises set forth in Paragraph 1.2(a) of the Form Lease, based on the BOMA Standard. Any such recalculations along with the re-measured rentable square footage of the Premises shall be confirmed by the Acknowledgment of Premises, in the form attached hereto as Exhibit “C”, executed by Lessor and Lessee. As used herein, the “BOMA Standard” shall mean the Standards of Measurement for Industrial Buildings (ANSI/BOMA Z65.2-2012) published by the Building Owners and Managers Association International.

2.2. Condition (continued). Lessee acknowledges that upon delivery of the Premises to Lessee, the Premises shall be in its then condition AS-IS AND WITH ALL ITS FAULTS, including without limitation, any faults and conditions specifically referenced in the Lease. No person acting on behalf of Lessor is authorized to make, and Lessee acknowledges and agrees that Lessor has not made and specifically negates and disclaims, any representations, warranties, promises, covenants, agreements or guaranties of any kind or character whatsoever, whether express or implied, oral or written, past, present or future, of, as to, concerning or with respect to the Premises.

Lessor and Lessee shall jointly inspect the Premises prior to the date Lessee takes possession of the same and memorialize the condition of the Premises in the attached move-in premises condition form. Any portion of the Premises that is not depicted in said move-in premises condition form (or the entire Premises, if Lessor and Lessee neglect to prepare such move-in premises condition form) shall be deemed to be in good condition and repair.

2.2(a) Lessor’s Disclosure Regarding Hazardous Substances. LESSOR HEREBY DISCLOSES TO LESSEE THAT, BASED ON THE AGE OF THE BUILDING, LESSOR HAS REASONABLE CAUSE TO BELIEVE THAT ASBESTOS-CONTAINING MATERIALS MAY BE PRESENT IN THE BUILDING AND THE PREMISES. LESSEE ACKNOWLEDGES THAT LESSOR HAS SATISFIED ITS OBLIGATION TO NOTIFY LESSEE OF THE PRESENCE OF ASBESTOS-CONTAINING MATERIALS IN THE BUILDING PURSUANT TO CALIFORNIA HEALTH & SAFETY CODE SECTION 25359.7, AND LESSEE SHALL NOT DISTURB ANY MATERIALS THAT MAY CONTAIN ASBESTOS.

 

Lessee Initials:   LOGO

 

1


2.4. Acknowledgements (continued). Without limiting the generality of Paragraph 2.4 of the Form Lease, Lessee represents and warrants that it has obtained (or will obtain) all required occupancy permits from the City of Santa Clarita and other agencies having jurisdiction over the Premises.

2.6. Parking (continued). The parking areas of the property shall be used for parking of Permitted Size Vehicles and, subject to Lessor’s rules and regulations, the loading and unloading of trucks only. The use by Lessee of those areas for storage material (including pallets) is expressly prohibited. All material shall be stored within the building.

2.9 Common Areas – Rules & Regulations (continued). Lessee will make use of all of the Common Areas (including, without limitation, all loading and unloading areas) in a cooperative, harmonious fashion, and shall not block or unreasonably interfere with access by others in the Project to their premises or loading areas.

6.1. Use (continued). Other than guide, signal, seeing-eye dogs, and validated service animals, subject to Lessor’s prior approval, Lessee shall not keep or allow in the Premises any pets, animals, birds, fish or reptiles.

7.3(d) Utility Installations (continued). Without limiting Lessor’s other rights under this Lease, Lessor reserves the right to install new or additional utility facilities in and/or through the Premises for the benefit of Lessor or Lessee or any other portion of the Project, without limitation, drains, plumbing, water, sewers, gas, electrical systems, security systems, communication systems, fire sprinklers, fire protection and detection systems.

7.4(b) Removal (continued). Notwithstanding Paragraph 7.4(b) of the Form Lease, Lessee may include the following notice (in bold, all capitalized twelve point type) in its request for consent to any Utility Installation or Alterations which Lessee desires to make to the Premises: “LESSOR’S RESPONSE TO THIS REQUEST FOR CONSENT MUST INCLUDE LESSOR’S ELECTION TO REQUIRE LESSEE TO REMOVE THE SUBJECT UTILITY INSTALLATION OR ALTERATION AT THE EXPIRATION OF THE LEASE TERM OR LESSOR WILL BE DEEMED TO HAVE WAIVED ITS RIGHT TO REQUIRE LESSEE TO REMOVE SAID UTILITY INSTALLATION OR ALTERATION”. Lessee shall not be required to remove the particular Utility Installation or Alteration at the expiration of the Term if the foregoing bold all capitalized language was included in Lessee’s request for consent and Lessor failed to make such election in its response thereto; provided, however, that Lessor’s waiver, if any, shall automatically (and retroactively) be void if this Lease terminates as a result of Lessee’s default.

7.4(c) Surrender/Restoration (continued). Without limiting Lessee’s obligations under the Lease, Lessee acknowledges that it shall have the affirmative obligation to remove all racking and floor striping from the Premises by or before the expiration or earlier termination of the Original Term or the Option Term, if any. As guidance to the Parties, removal of the aforementioned racking shall include, without limitation, removal of the concrete anchor bolts associated therewith, all of which cut flush at the surface and pushed into the concrete one inch or more below the slab. Lessee shall clean all resulting holes and shall fill the same with epoxy flush to the floor’s surface. Lessee understands that the holes created for any anchor bolts placed by or on behalf of Lessee must be drilled one inch deeper than the length of the anchor bolts themselves to permit removal in the manner provided above. Furthermore, if Lessee places (or causes to be placed) any floor striping in the Premises, then following removal of any such floor striping (i) there shall be no residual staining or other indication that such stripping existed and (ii) Lessee must re-seal the floor with a sealant reasonably acceptable to Lessor. If Lessee elects to stripe the floor of the Premises, then Lessee shall utilize a floor striping material which can be removed and which will not permeate into the flooring. The foregoing does not constitute Lessor’s consent to Lessee’s placement of any racking and/or floor striping in the Premises, which placement shall be governed by the provision of the Lease.

11. Utilities & Services (continued). Lessee shall not use the trash bins of the Project other than for disposal of ordinary office refuse. In no event shall Lessee use the bins for the disposal of large items, such as (but not limited to) packing crates, furniture, storage pallets.

Lessee shall be responsible and pay for all separately metered utilities servicing the Premises.

 

2


12.2(h) Terms and Conditions Applicable to Both Assignment and Subletting (continued). If Lessor consents to any assignment or subletting of Lessee’s interest in this Lease, as a condition thereto which the parties hereby agree is reasonable, Lessee shall pay to Lessor fifty percent (50%) of any “Transfer Premium,” as that term is defined in this Paragraph 12.2(h), actually received by Lessee from the assignee or Sublessee in connection with the Transfer. “Transfer Premium” shall mean all rent, additional rent or other consideration payable by such assignee or Sublessee in connection with a assignment or subletting in excess of the Base Rent and Common Area Operating Expenses payable by Lessee under this Lease during the term of the applicable assignment or subletting on a per rentable area square foot basis if less than all of the Premises is transferred (unless all or a portion of the subject space is subject to different Base Rent and Common Area Operating Expenses terms, in which case, to the extent applicable, such different terms shall be applicable), after deducting the expenses incurred or to be incurred by Lessee for the following, to the extent commercially reasonable under the circumstances, (collectively, “Transfer Costs”): (i) any changes, alterations and improvements to the Premises in connection with the subject assignment or subletting, (ii) any space planning, architectural or design fees or expenses incurred in marketing such space or in connection with such Transfer, (iii) any customary and market reasonable improvement allowance or other customary and market reasonable monetary concessions provided to the assignee or Sublessee, (iv) any brokerage commissions incurred by Lessee in connection with the assignment or subletting, (v) reasonable good faith attorneys’ fees incurred by Lessee in connection with the assignment or subletting (excluding, in all cases, the fees of any “in-house” attorneys), and (vi) any lease takeover costs incurred by Lessee in connection with the assignment or subletting. “Transfer Premium” shall also include, but not be limited to, key money, bonus money or other cash consideration actually paid by assignee or Sublessee to Lessee in connection with such assignment or subletting, and any payment in excess of fair market value for services rendered by Lessee to the assignee or Sublessee or for assets, fixtures, inventory, equipment, or furniture transferred by Lessee to assignee or Sublessee in connection with such assignment or subletting. The determination of the amount of Lessor’s applicable share of the Transfer Premium shall be made on a monthly basis as rent or other consideration is received by Lessee under the assignment or subletting. For purposes of calculating the Transfer Premium on a monthly basis, (x) Lessee’s Transfer Costs shall be deemed to be expended by Lessee in equal monthly amounts over the entire term of the subject assignment or subletting (provided, however, at the election of Lessee, in its sole discretion, Lessee may amortize all or any portion of such Transfer Costs over a shorter period or may elect to allocate such Transfer Costs to the earliest portion of the term of such Transfer until such Transfer Costs are exhausted) and (y) the Rent paid for the subject space by Lessee shall be computed after adjusting such rent to the actual effective rent to be paid, taking into consideration any and all cash concessions actually paid in cash to Lessee by Lessor in connection therewith. For purposes of calculating any such effective rent all such concessions shall be amortized on a straight-line basis without interest over the relevant term.

23.1 Notices (Continued). Copies of any notices delivered to Lessor shall be sent concurrently to Rexford Industrial Realty, L.P., 11620 Wilshire Boulevard, Suite 1000, Los Angeles, CA 90025, Tel. 310.966.1680, Fax 310.966-1690; Attn.: General Counsel, DLanzer@rexfordindustrial.com and to Kenneth S. Fields, Esq., Greenberg Glusker Fields Claman & Machtinger LLP, 1900 Avenue of the Stars, 21 st Floor, Los Angeles, CA 90067; Tel. 310.201.7462; Fax 310.201.2376; KFields@greenbergglusker.com.

34. Signs (continued). Lessee, at its sole expense, shall have the option to install suite identity signage on the unit entry. Should Lessee execute the option to install signage, Lessee must obtain Lessor’s approval of design and configuration prior to the installation. Lessor may also provide the option of common signage. Subject to the then current Building/Project standard signage program, Lessee shall have the ability to install exterior building signage outside the lobby entrance and suite adjacent identity signage at Lessee’s sole cost and expense.

48. Arbitration of Disputes. Attached hereto and made a part hereof.

49. Americans with Disabilities Act (Continued). Pursuant to California Civil Code Section 1938, Lessor hereby discloses that the Premises have not undergone an inspection by a Certified Access Specialist to determine whether the Premises meet all applicable construction-related accessibility standards.

50. Rent Adjustment. Attached hereto and made a part hereof.

51. Option to Extend. Attached hereto and made a part hereof.

 

3


52. Lessor Improvements. Lessor shall, at Lessor’s sole cost and expense, complete the following improvements to the Premises, as depicted on the attached Exhibit “B”, using building standard materials:

 

  i.

Demise Premises from balance of mezzanine;

 

  ii.

Cap existing staircase area;

 

  iii.

Modify existing staircase area & adjacent existing office with sidelights similar to existing offices and matching carpet, if available in two (2) new offices;

 

  iv.

Install one (1) lunchroom with sink, ventilation, dishwasher and building standard plastic laminate cabinetry (both upper & lower). Lessee shall be responsible for purchasing the dishwasher and refrigerator. Lessor shall provide plumbing and power for the dishwasher and power for the refrigerator.

 

  v.

Install storage room which shall be divided internally into two (2) separate storage areas;

 

  vi.

Expand existing storage closet area at suite entrance and install closet lighting;

 

  vii.

Provide Voice/Date hub to Premises IT closet (expanded storage closet);

 

  viii.

Install power pulls for twelve (12) cubicles in locations agreeable to Lessee;

 

  ix.

Install three (3) interior offices with sidelights similar to existing offices and matching carpet, if available with approximate 10’ x l2’ dimensions; and

 

  x.

Install building standard VCT in breakroom.

Lessee acknowledges and agrees that the Lessor Improvement work will be continuing during Lessee’s occupancy and, although Lessor will use commercially reasonable efforts to minimize any disturbance to Lessee, some disturbance is unavoidable and the Lessor shall, and shall cause its contractors to, use commercially reasonable efforts to minimize the dust, noise and other interference with Lessee’s business operations and to protect Lessee’s employees and invitees from injury and Lessee’s personal property and Trade Fixtures at the Premises from damage; however, Lessee understands that some interference is unavoidable and the provisions of Paragraph 8.8 of the Form Lease shall apply in connection therewith.

Lessee shall be solely responsible for moving any furniture, fixtures, or any of Lessee’s personal property within the Premises, if necessary, at Lessee’s sole cost and expense, so that Lessor can perform the Lessor Improvements.

53. Solar Energy. Lessee agrees and understands that Lessor shall have the right (provided that the exercise of Lessor’s rights does not materially and adversely affect Lessee’s use and occupancy of the Premises or subject Lessee to additional costs, without Lessee’s consent, to place a solar electric generating system on the roof of the Building or enter into a lease for the roof of the Building whereby such roof lessee shall have the right to install a solar electric generating system on the roof of the Building, and Lessor and its agents shall have access to the roof to accomplish the foregoing.

54. Provisions Regarding Bankruptcy.

a. Assumption of Lease.

In addition to any rights or remedies of Lessor under the terms of this Lease, in the event Lessee engages in any one or more of the acts contemplated by the provisions of Section 13.1(f) above and in the event of an assumption of this Lease by a debtor or by a trustee, such debtor or trustee shall within fifteen (15) days after such assumption (i) cure any default or provide adequate assurance that any default will be promptly cured; and (ii) compensate Lessor for actual pecuniary loss or provide adequate assurance that compensation will be made for actual pecuniary loss including, but not limited to, all attorneys’ fees and costs incurred by Lessor resulting from any such proceedings; and (iii) provide adequate assurance of future performance. Lessor and Lessee agree that such fifteen (15) day period is reasonable in view of the fact that the Premises is one of a part of an integrated retail center where the performance by each tenant of its obligations has an effect on the well being of all other tenants and Lessor. Any proposed assignee, including shareholders of a corporate assignee of this Lease, must assume and agree to personally guarantee the performance by assignee of the terms, provisions and covenants of this Lease.

 

4


b. Relief From Automatic Stay.

If any of the events described in Section 13.1(f) shall occur with regard to Lessee, Lessee hereby irrevocably consents to immediate relief from the automatic stay under 11 U.S.C. Section 362(d).

55. Confidentiality. It is understood that Lessee shall hold the terms and conditions of this Lease in the strictest of confidence. Lessee shall not disclose the terms of this Lease to any other existing or prospective tenants in the building

56. Interpretation. The Form Lease and this Addendum shall be deemed to have been drafted by both parties and shall not be interpreted against any person as drafter. In addition, prior drafts of the Lease or this Addendum or any letters of intent regarding the same shall not be used in any way to interpret the provisions hereof.

57. REIT Provisions. Lessee understands that, in order for an indirect owner of Lessor to qualify as a REIT, the following requirements (the “REIT Requirements”) must be satisfied:

57.1 Subleasing. Anything contained in this Lease to the contrary notwithstanding, Lessee shall not sublet the Premises on any basis such that the rent or other amounts to be paid by the sublessee thereunder would be based, in whole or in part, on either (i) the net income or profits derived by the business activities of the proposed sublessee, or (b) any other formula such that any portion of the Rent would fail to qualify as “rents from real property” within the meaning of Section 856(d) of the Internal Revenue Code, or any similar or successor provision hereto.

57.2 Personal Property Limitation. Anything contained in the Lease to the contrary notwithstanding, the average of the fair market values of the items of personal property that are leased to Lessee under the Lease at the beginning and at the end of any year shall not exceed fifteen percent (15%) of the average of the aggregate fair market values of the leased property at the beginning and at the end of such year (the “Personal Property Limitation”). If Lessor reasonably anticipates that the Personal Property Limitation will be exceeded with respect to the leased property for any year, Lessor shall notify Lessee, and Lessee either (i) shall purchase at fair market value any personal property anticipated to be in excess of the Personal Property Limitation (“Excess Personal Property”) either from Lessor or a third party or (ii) shall lease the Excess Personal Property from a third party. In either case, Lessee’s Base Rent obligation shall be equitably adjusted. Notwithstanding anything to the contrary set forth above, Lessee shall not be responsible in any way for determining whether Lessee has exceeded or will exceed the Personal Property Limitation and shall not be liable to Lessor or any of its shareholders in the event that the Personal Property Limitation is exceeded, as long as Lessee meets its obligation to acquire or lease any Excess Personal Property as provided above. This section is intended to ensure that the Rent qualifies as “rents from real property,” within the meaning of Section 856(d) of the Internal Revenue Code, or any similar or successor provisions thereto, and shall be interpreted in a manner consistent with such intent.

57.3 REIT Requirements. Lessee agrees, and agrees to use its reasonable efforts to cause its affiliates, to cooperate in good faith with Lessor to ensure that the terms of this Paragraph are satisfied. Lessee agrees, and agrees to use reasonable efforts to cause its affiliates, upon request by Lessor to take reasonable action necessary to ensure compliance with all REIT Requirements. If Lessee becomes aware that the REIT Requirements are not, or will not be, satisfied, Lessee shall notify, or use reasonable efforts to cause its affiliates to notify Lessor of such noncompliance. Notwithstanding anything herein to the contrary, in the event that Lessee defaults in its obligations under this Paragraph 57 with respect to the REIT Requirements and fails to cure the same within thirty (30) days after written notice from Lessor, then Lessor’s sole remedy for Lessee’s Breach of its obligations under this Paragraph 57 shall be to terminate the Lease (provided, however, that the preceding shall not limit Lessor’s right to pursue all other available remedies in connection with a Default or Breach by Lessee of any other obligations or provisions under the Lease other than those set forth in this Paragraph 57).

[SIGNATURE PAGE FOLLOWS]

 

5


NOW, THEREFORE, the parties have executed this Addendum and the Lease as of the date set forth above.

 

LESSOR   

LESSEE

RIF III – AVENUE STANFORD, LLC, A CALIFORNIA LIMITED LIABILITY COMPANY   

AVITA MEDICAL AMERICAS, LLC, A DELAWARE LIMITED LIABILITY COMPANY

 

By:  

Rexford Industrial Realty, L.P., a

Maryland limited partnership, Its

Managing Member

  

By:

  

Rexford Industrial Realty, Inc., a

Maryland corporation, Its General

Partner

  
 

By:

      /s/ Howard Schwimmer                                                 By: /s/ Troy Barring                                               
 

    Name Printed: Howard Schwimmer

   Name Printed: Troy Barring
 

    Title: Co-Chief Executive Officer

   Title: Chief Operating Officer
           By:                                                                              
           Name Printed:                                                             
           Title:                                                                           

 

6


LOGO

ARBITRATION AGREEMENT

Standard Lease Addendum

 

  Dated    October 3, 2016
  By and Between (Lessor)    RIF III - Avenue Stanford, LLC, a California limited liability company
  (Lessee)    Avita Medical Americas, LLC, a Delaware limited liability company
  Address of Premises:    28159 Avenue Stanford, Unit 220 Valencia, California, 91355

Paragraph 48

 

A.

ARBITRATION OF DISPUTES:

Except as provided in Paragraph B below, the Parties agree to resolve any and all claims, disputes or disagreements arising under this Lease, including, but not limited to any matter relating to Lessor’s failure to approve an assignment, sublease or other transfer of Lessee’s interest in the Lease under Paragraph 12 of this Lease, any other defaults by Lessor, or any defaults by Lessee by and through arbitration as provided below and irrevocably waive any and all rights to the contrary. The Parties agree to at all times conduct themselves in strict, full, complete and timely accordance with the terms hereof and that any attempt to circumvent the terms of this Arbitration Agreement shall be absolutely null and void and of no force or effect whatsoever.

 

B.

DISPUTES EXCLUDED FROM ARBITRATION:

The following claims, disputes or disagreements under this Lease are expressly excluded from the arbitration procedures set forth herein: 1. Disputes for which a different resolution determination is specifically set forth in this Lease, 2. All claims by either party which (a) seek anything other than enforcement or determination of rights under this Lease, or (b) are primarily founded upon matters of fraud, willful misconduct, bad faith or any other allegations of tortious action, and seek the award of punitive or exemplary damages, 3. Claims relating to (a) Lessor’s exercise of any unlawful detainer rights pursuant to applicable law or (b) rights or remedies used by Lessor to gain possession of the Premises or terminate Lessee’s right of possession to the Premises, all of which disputes shall be resolved by suit filed in the applicable court of jurisdiction, the decision of which court shall be subject to appeal pursuant to applicable law 4. Any claim or dispute that is within the jurisdiction of the Small Claims Court and 5. All claims arising under Paragraph 39 of this Lease.

 

C.

APPOINTMENT OF AN ARBITRATOR:

All disputes subject to this Arbitration Agreement, shall be determined by binding arbitration before: ☑ a retired judge of the applicable court of jurisdiction (e.g., the Superior Court of the State of California) affiliated with Judicial Arbitration & Mediation Services, Inc. (“JAMS”), ☐ the American Arbitration Association (“AAA”) under its commercial arbitration rules, ☐                                                                                                             

                                                                                                                                                                                                                                                          ,

or as may be otherwise mutually agreed by Lessor and Lessee (the “Arbitrator”). Such arbitration shall be initiated by the Parties, or either of them, within ten (10) days after either party sends written notice (the “Arbitration Notice”) of a demand to arbitrate by registered or certified mail to the other party and to the Arbitrator. The Arbitration Notice shall contain a description of the subject matter of the arbitration, the dispute with respect thereto, the amount involved, if any, and the remedy or determination sought. If the Parties have agreed to use JAMS they may agree on a retired judge from the JAMS panel. If they are unable to agree within ten days, JAMS will provide a list of three available judges and each party may strike one. The remaining judge (or if there are two, the one selected by JAMS) will serve as the Arbitrator. If the Parties have elected to utilize AAA or some other organization, the Arbitrator shall be selected in accordance with said organization’s rules. In the event the Arbitrator is not selected as provided for above for any reason, the party initiating arbitration shall apply to the appropriate Court for the appointment of a qualified retired judge to act as the Arbitrator.

 

D.

ARBITRATION PROCEDURE:

1. PRE-HEARING ACTIONS. The Arbitrator shall schedule a pre-hearing conference to resolve procedural matters, arrange for the exchange of information, obtain stipulations, and narrow the issues. The Parties will submit proposed discovery schedules to the Arbitrator at the pre-hearing conference. The scope and duration of discovery will be within the sole discretion of the Arbitrator. The Arbitrator shall have the discretion to order a pre-hearing exchange of information by the Parties, including, without limitation, production of requested documents, exchange of summaries of testimony of proposed witnesses, and examination by deposition of parties and third-party witnesses. This discretion shall be exercised in favor of discovery reasonable under the circumstances. The Arbitrator shall issue subpoenas and subpoenas duces tecum as provided for in the applicable statutory or case law (e.g., in California Code of Civil Procedure Section 1282.6).

2. THE DECISION. The arbitration shall be conducted in the city or county within which the Premises are located at a reasonably convenient site. Any Party may be represented by counsel or other authorized representative. In rendering a decision(s), the Arbitrator shall determine the rights and obligations of the Parties according to the substantive laws and the terms and provisions of this Lease. The Arbitrator’s decision shall be based on the evidence introduced at the hearing, including all logical and reasonable inferences therefrom. The Arbitrator may make any determination and/or grant any remedy or relief that is just and equitable. The decision must be based on, and accompanied by, a written statement of decision explaining the factual and legal basis for the decision as to each of the principal controverted issues. The decision shall be conclusive and binding, and it may thereafter be confirmed as a judgment by the court of applicable jurisdiction, subject only to challenge on the grounds set forth in the applicable statutory or case law (e.g., in California Code of Civil Procedure Section 1286.2). The validity and enforceability of the Arbitrator’s decision is to be determined exclusively by the court of appropriate jurisdiction pursuant to the provisions of this Lease. The Arbitrator may award costs, including without limitation. Arbitrator’s fees and costs, attorneys’ fees, and expert and witness costs, to the prevailing party, if any, as determined by the Arbitrator in his discretion.

Whenever a matter which has been submitted to arbitration involves a dispute as to whether or not a particular act or omission (other than a failure to pay money) constitutes a Default, the time to commence or cease such action shall be tolled from the date that the Notice of Arbitration is served through and until the date the Arbitrator renders his or her decision. Provided, however, that this provision shall NOT apply in the event that the Arbitrator determines that the Arbitration Notice was prepared in bad faith.

 

©1997 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM ARB-2-2/13E

PAGE 1 OF 2


Whenever a dispute arises between the Parties concerning whether or not the failure to make a payment of money constitutes a default, the service of an Arbitration Notice shall NOT toll the time period in which to pay the money. The Party allegedly obligated to pay the money may, however, elect to pay the money “under protest” by accompanying said payment with a written statement setting forth the reasons for such protest. If thereafter, the Arbitrator determines that the Party who received said money was not entitled to such payment, said money shall be promptly returned to the Party who paid such money under protest together with Interest thereon as defined in Paragraph 13.5. If a Party makes a payment “under protest” but no Notice of Arbitration is filed within thirty days, then such protest shall be deemed waived. (See also Paragraph 42 or 43)

NOTICE: These forms are often modified to meet changing requirements of law and industry needs. Always write or call to make sure you

are utilizing the most current form: AIR Commercial Real Estate Association, 500 N Brand Blvd. Suite 900, Glendale, CA 91203.

Telephone No. (213) 687-8777. Fax No.: (213) 687-8616.

 

©1997 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM ARB-2-2/13E

PAGE 2 OF 2


LOGO

RENT ADJUSTMENT(S)

STANDARD LEASE ADDENDUM

 

  Dated    October 3, 2016
  By and Between (Lessor)    RIF III – Avenue Stanford, LLC, a California limited liability company
  (Lessee)    Avita Medical Americas, LLC, a Delaware limited liability company
  Address of Premises:    28159 Avenue Stanford, Unit 220
     Valencia, California, 91355

Paragraph 50

 

A.

RENT ADJUSTMENTS:

The monthly rent for each month of the adjustment period(s) specified below shall be increased using the method(s) indicated below: (Check Method(s) to be Used and Fill in Appropriately)

 

i.     Cost of Living Adjustment(s) (COLA)

        a.    On (fill in COLA Dates:                                                                                                                                                                                                  

 

 

 

 

the Base Rent shall be adjusted by the change, if any, from the Base Month specified below, in the Consumer Price Index of the Bureau of Labor Statistics of the U.S. Department of Labor for (select one):☐ CPI W (Urban Wage Earners and Clerical Workers) or ☐ CPI U (All Urban Consumers), for (Fill in Urban Area):

 

 

 

 

                                                                                                                                                                                                                                              , All Items

(1982-19884 – 100), herein referred to as “CPI”.

        b.    The monthly Base Rent payable in accordance with paragraph A.I.a. of this Addendum shall be calculated as follows: the Base Rent set forth in paragraph 1.5 of the attached Lease, shall be multiplied by a fraction the numerator of which shall be the CPI of the calendar month 2 months prior to the month(s) specified in paragraph A.I.a. above during which the adjustment is to take effect, and the denominator of which shall be the CPI of the calendar month which is 2 months prior to (select one): the ☐ first month of the term of this Lease as set forth in paragraph 1.3 (“Base Month”) or ☐ (Fill in Other “Base Month”):                                                                              . The sum so calculated shall constitute the now monthly Base Rent hereunder, but in no event, shall any such now monthly Base Rent be less than the Base Rent payable for the month immediately preceding the Base Rent adjustment.

        c.    In the event the compilation and/or publication of the CPI shall be transferred to any other governmental deportment or bureau or agency or shall be discontinued, then the index most nearly the same as the CPI shall be used to make such calculation, In the event that the Parties cannot agree on such alternative index, then the matter shall be submitted for decision to the American Arbitration Association in accordance with the then rules of said Association and the decision of the arbitrators shall be binding upon the parties. The cost of said Arbitration shall be paid equally by the Parties.

 

II.     Market Rental Value Adjustment(s) (MRV)

a.      On (fill in MRV Adjustment Date(s):                                                                                                                                                                         

 

 

 

 

the Base Rent shall be adjusted to the “Market Rental Value” of the property as follows:

1) Four months prior to each Market Rental Value Adjustment Date described above, the Parties shall attempt to agree upon what the

now MRV will bo on the adjustment date. If agreement cannot bo reached within thirty days, then:

(a) Lesser and Lessee shall immediately appoint a mutually acceptable appraiser or broker to establish the now MRV within the next 30 days. Any associated costs will be split equally between the Parties, or

(b) Both Lessor and Lessee shall each immediately make a reasonable determination of the MRV and submit such determination, in writing, to arbitration in accordance with the following provisions:

(i) Within 15 days thereafter, Lessor and Lessee shall each select an ☐ appraiser or [] broker (“Consultant” chock one) of their choice to act as an arbitrator. The two arbitrators so appointed shall immediately select a third mutually acceptable Consultant to act as a third arbitrator.

(ii) The 3 arbitrators shall within 30 days of the appointment of the third arbitrator reach a decision as to what the

actual MRV for the Promises is, and whether Lesser’s or Lessee’s submitted MRV is the closest thereto. The decision of a majority of the arbitrators shall be binding on the Parties. The submitted MRV which is determined to bo the closest to the actual MRV shall thereafter bo used by the Parties.

 

©2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM RA-5-04/14E

PAGE 1 OF 2


                                             (iii) If either of the Parties fails to appoint an arbitrator within the specified 16 days, the arbitrator timely appointed by one of them shall reach a decision on his or her own, and said decision shall be binding on the Parties.

                                             (iv) The entire cost of such arbitration shall be paid by the party whose submitted MRV is not selected, i.e., the one that is NOT the closest to the actual MRV.

                                 2) When determining MRV, the Lessor, Lessee and Consultants shall consider the terms of comparable market transactions which shall include, but no limited to, rent, rental adjustments, abated rent, lease term and financial condition of tenants.

                                 3) Notwithstanding the foregoing, the now Base Rent shall not be less than the rent payable for the month immediately preceding the rent adjustment.

                      b. Upon the establishment of each New Market Rental Value:

                                 1) the now MRV will become the new “Base Rent” for the purpose of calculating any further Adjustments, and -

                                 2) the first month of each Market Rental Value term shall become the now ‘Base Month’ for the purpose of calculating any further Adjustments.

 

III. Fixed Rental Adjustment(s) (FRA)

The Base Rent shall be increased to the following amounts on the dates set forth below:

 

     On (Fill in FRA Adjustment Date(s)):         The New Base Rent shall be:     
   December 1, 2017       $20,096.59   
   December 1, 2018       $20,699.49   
   December 1, 2019       $521,320.47   
               
               
               
               
               
               
               

In addition to the Base Kent, Lessee shall only be required to pay any increases in Operating Expenses, Insurance Premiums and Real Property Taxes over the Base Year.

     IV. Initial Term Adjustments.

The formula used to calculate adjustments to the Base Rate during the original Term of the Lease shall continue to be used during the extended term.

 

B.

NOTICE:

Unless specified otherwise herein, notice of any such adjustments, other than Fixed Rental Adjustments, shall be made as specified in paragraph 23 of the Lease.

C.     BROKER’S FEE:

         The Brokers shall be paid a Brokerage Fee for each adjustment specified above in accordance with paragraph 15 of the Lease or if applicable, paragraph 9 of the Sublease.

NOTICE: These forms are often modified to meet changing requirements of law and industry needs. Always write or call to make sure you

are utilizing the most current form: AIR Commercial Real Estate Association, 500 N Brand Blvd, Suite 900, Glendale, CA 91203.

Telephone No. (213) 687-8777. Fax No.: (213) 687-8616.

 

©2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM RA-5-04/14E

PAGE 2 OF 2


LOGO

OPTION(S) TO EXTEND

STANDARD LEASE ADDENDUM

 

  Dated    October 3, 2016
  By and Between (Lessor)    RIF III – Avenue Stanford, LLC, a California limited liability company
  By and Between (Lessee)    Avita Medical Americas, LLC, a Delaware limited liability company
  Address of Premises:    28159 Avenue Stanford, Unit 220
     Valencia, California, 91355

Paragraph 51

A. OPTION(S) TO EXTEND:

Lessor hereby grants to Lessee the option to extend the term of this Lease for one (1) additional thirty-six (36) month period(s) commencing when the prior term expires upon each and all of the following terms and conditions:

(i) In order to exercise an option to extend, Lessee must give written notice of such election to Lessor and Lessor must receive the same at least 6 but not more than 9 months prior to the date that the option period would commence, time being of the essence. If proper notification of the exercise of an option is not given and/or received, such option shall automatically expire. Options (if there are more than one) may only be exercised consecutively.

(ii) The provisions of paragraph 39, including those relating to Lessee’s Default set forth in paragraph 39.4 of this Lease, are conditions of this Option.

(iii) Except for the provisions of this Lease granting an option or options to extend the term, all of the terms and conditions of this Lease except where specifically modified by this option shall apply.

(iv) This Option is personal to the original Lessee, and cannot be assigned or exercised by anyone other than said original Lessee and only while the original Lessee is in full possession of the Premises and without the intention of thereafter assigning or subletting.

(v) The monthly rent for each month of the option period shall be calculated as follows, using the method(s) indicated below: (Check Method(s) to be Used and Fill in Appropriately)

     I.    Cost of Living Adjustment(s) (COLA)

 

          a.    

On (Fill in COLA Dates):                                                                                                                                                                                                

 

 

 

 

the Base Rent shall be adjusted by the Change. if any, from the Base Month specified below, in the Consumer Price Index of the Bureau of Labor Statistics of the U.S. Department of Labor for (select one): ☐ CPI W (Urban Wage Earners and Clerical Workers) or ☐ CPI U (All Urban Consumers), for (Fill in Urban Area): -

 

 

 

 

All items (1982 1984—100), herein referred to as “CPI”.

         b. The monthly Base Rent payable in accordance with paragraph A.I.a. of this Addendum shall be calculated as follows: the Base Rent set forth in paragraph 1.5 of the attached Lease, shall be multiplied by a fraction the numerator of which shall be the CPI of the calendar month 2 months prior to the month(c) specified in paragraph A.I.a. above during which the adjustment is to take effect, and the denominator of which shall be the CPI of the calendar month which is 2 months prior to (select one): ☐ the first month of the term of this Lease as set forth in paragraph 1.3 (“Base Month”) or ☐ (Fill in Other “Base Month”): -

 

 

 

 

The sum so calculated shall constitute the now monthly Base Rent hereunder, but in no event, shall any such now monthly Base Rent bo loss than the Base Rent payable for the month immediately preceding the rent adjustment.

         c. In the event the compilation and/or publication of the CPI shall bo transferred to any other governmental department or bureau or agency or shall be discontinued, then the index most nearly the same as the CPI shall be used to make such calculation. In the event that the Parties cannot agree on such alternative index. then the matter shall be submitted for decision to the American Arbitration Association in accordance with the then rules of said Association and the decision of the arbitrators shall be binding upon the parties. The cost of said Arbitration shall be paid equally by the Parties.

 

     II.    

Market Rental Value Adjustment(s) (MRV)

 

          a.    

On (Fill in MRV Adjustment Date(s)) January 1, 2021                                                                                                                                                

 

 

the Base Rent shall be adjusted to the “Market Rental Value” of the property as follows, but in no event less than a three percent (3%) increase over the Base Rent then in effect:

1) Four months prior to each Market Rental Value Adjustment Date described above, the Parties shall attempt to agree upon what the new MRV will be on the adjustment date. If agreement cannot be reached, within thirty days, then:

(a) Lessor and Lessee shall immediately appoint a mutually acceptable appraiser or broker to establish the new MRV within the next 30 days. Any associated costs will be split equally between the Parties, or

 

©2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION

OE-4-04/14E

   FORM

PAGE 1 OF 2


(b) Both Lessor and Lessee shall each immediately make a reasonable determination of the MRV and submit such determination, in writing, to arbitration in accordance with the following provisions:

(i) Within 15 days thereafter, Lessor and Lessee shall each select an ☐ appraiser or ☑ broker (Consultant - check one) of their choice to act as an arbitrator. The two arbitrators so appointed shall immediately select a third mutually acceptable Consultant to act as a third arbitrator.

(ii) The 3 arbitrators shall within 30 days of the appointment of the third arbitrator reach a decision as to what the actual MRV for the Premises is, and whether Lessor’s or Lessee’s submitted MRV is the closest thereto. The decision of a majority of the arbitrators shall be binding on the Parties. The submitted MRV which is determined to be the closest to the actual MRV shall thereafter be used by the Parties.

(iii) If either of the Parties fails to appoint an arbitrator within the specified 15 days, the arbitrator timely appointed by one of them shall reach a decision on his or her own, and said decision shall be binding on the Parties.

(iv) The entire cost of such arbitration shall be paid by the party whose submitted MRV is not selected, ie. the one that is NOT the closest to the actual MRV.

2) When determining MRV, the Lessor, Lessee and Consultants shall consider the terms of comparable market transactions which shall include, but no limited to, rent, rental adjustments, abated rent, lease term and financial condition of tenants.

3) Notwithstanding the foregoing, the new Base Rent shall not be less than the rent payable for the month immediately preceding the rent adjustment.

b. Upon the establishment of each New Market Rental Value:

1) the new MRV will become the new “Base Rent” for the purpose of calculating any further Adjustments, and

2) the first month of each Market Rental Value term shall become the new “Base Month” for the purpose of calculating any further Adjustments.

c. In addition to the Base Rent, Lessee shall only be required to pay any increases in Operating Expenses, insurance Premiums and Real Property Taxes over the Base Year.

III. Fixed Rental Adjustment(s) (FRA)

The Base Rent then in effect immediately preceding the FRA Adjustment Date shall be increased to the following amounts per the formula and on the dates set forth below:

 

  On (Fill in FRA Adjustment Date(s)):      The Now Base Rent shall be:   
  January 1, 2022      increased by three percent (3%)   
 

 

    

 

  
  January 1, 2023      increased by three percent (3%)   
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  
         
 

 

    

 

  

IV Initial Term Adjustments.

The formula used to calculate adjustments to the Base Rote during the original Term of the Lease shall continue to be used during the extended term

B. NOTICE:

Unless specified otherwise herein, notice of any rental adjustments, other than Fixed Rental Adjustments, shall be made as specified in paragraph 23 of the Lease.

C. BROKER’S FEE:

                      The Brokers shall be paid a Brokerage Fee for each adjustment specified above in accordance with paragraph 15 of the Lease or if applicable), paragraph 0 of the Sublease.

NOTICE: These forms are often modified to meet changing requirements of law and industry needs. Always write or call to make sure you

are utilizing the most current form: AIR Commercial Real Estate Association, 500 N Brand Blvd, Suite 900, Glendale, CA 91203.

Telephone No. (213) 687-8777. Fax No.: (213) 687-8616.

 

©2000 - AIR COMMERCIAL REAL ESTATE ASSOCIATION    FORM
OE-4-04/14E   

PAGE 2 OF 2


EXHIBIT “A”

SITE PLAN

 

LOGO

Not to scale. Does not constitute a representation or warranty regarding the Project or any portion thereof, and Lessor reserves the right to modify any portion of the Project in its sole discretion as provided in the Lease.


EXHIBIT “B”

LESSOR IMPROVEMENTS

 

LOGO


LOGO


EXHIBIT “C”

ACKNOWLEDGEMENT OF PREMISES

 

  Lessor:    RIF III – Avenue Stanford, LLC, a California limited liability company
  Lessee:    Avita Medical Americas, LLC, a Delaware limited liability company

This Acknowledgment of Premises (this “Acknowledgment”) is made by Lessor and Lessee pursuant to that certain Standard Multi-Tenant Office Lease – Gross, dated as of October 3, 2016 (the “Lease”) for certain premises located at 28159 Avenue Stanford, Unit 220, Valencia, California, 91355, and as further described in the Lease (the “Premises”). This Acknowledgment is made pursuant to Paragraphs 1.2(a) of the Lease. Capitalized terms used herein but not defined herein shall have the meaning given them in the Lease.

1. Re-measurement of Premises. The rentable square footage of the Premises has been re-measured in accordance with Paragraph 1.2 of the Addendum to the Lease. Based on such re-measurement, the rentable square footage of the Premises is determined to be                          rentable square feet. Accordingly, the Base Rent, Lessee’s Share of Common Area Operating Expenses and the Security Deposit are hereby recalculated (and the Lease is hereby amended to reflect the same) as follows:

a. Base Rent. Paragraph 1.5 of the Lease is hereby amended to provide that the Base Rent payable by Lessee during the Original Term shall be as follows:

 

Period of Original Term

   Monthly Base Rent  

From the Commencement Date to the last day of the twelfth (12th) full calendar month of the Term

   $                    

From the first day of the thirteenth (13th) full calendar month of the Term

   $                    

From the first day of the twenty-fifth (25th) full calendar month of the Term

   $                    

From the first day of the thirty-seventh (37th) full calendar month of the Term

   $                    

b. Lessee’s Share of Common Area Operating Expenses. Paragraph 1.6 of the Lease is hereby amended to provided that Lessee’s Share of Common Area Operating Expenses shall be                      percent (            %) (“Lessee’s Share”).

c. Security Deposit. Paragraph 1.7(c) of the Lease is hereby amended to provide that the Security Deposit shall be $                     (“Security Deposit”).

d. Base Rent and Other Monies Paid Upon Execution. Lessor and Lessee shall reconcile any discrepancy in the amounts that Lessee paid upon execution pursuant to Paragraph 1.7 of the Lease for Base Rent and the Security Deposit in order to reflect the modifications set forth in this Acknowledgment. With respect to any overpayment of such amounts by Lessee, Lessor shall have the right to apply such overpayment to future Base Rent due under the Lease or to refund such overpayment to Lessee. With respect to any underpayment of such amounts by Lessee, Lessee shall pay the difference to Lessor within fifteen (15) days after the execution of this Acknowledgment.

2. Miscellaneous. This Acknowledgment is incorporated into the Lease, and forms an integral part thereof. This Acknowledgment shall be construed and interpreted in accordance with the terms of the Lease for all purposes. Except as modified by this Acknowledgment, the Lease remains unchanged, and, as modified by this Acknowledgment, the Lease is in full force and effect. In the event of any conflict between the terms of this Acknowledgment and the Lease, this


Acknowledgment shall control. This Acknowledgment may be executed in several counterparts, each of which may be deemed an original, but all of which together shall constitute one and the same Acknowledgment. In addition, properly executed, authorized signatures may be transmitted via facsimile and upon receipt shall constitute an original signature.

 

LESSOR

   LESSEE

RIF III – Avenue Stanford, LLC,

a California limited liability company

  

Avita Medical Americas, LLC,

a Delaware limited liability company

 

By:

  

Rexford Industrial Realty, L.P.,

a Maryland limited Partnership

Its Managing Member

  
   

By:

  

Rexford Industrial Realty, Inc.,

a Maryland corporation,

Its General Partner

  
      

By: /s/ Howard Schwimmer            

Name Printed: Howard Schwimmer

Title: Co-Chief Executive Officer

  

By:                                                      

Name Printed:                                   

Title:                                                   

         

By:                                                      

Name Printed:                                   

Title:                                                   


LOGO


LOGO

Tenant Contact Information

Please complete and return this form immediately to:

 

Rexford Industrial, LLC

11620 Wilshire Boulevard, Suite 1000

Los Angeles, California 90025

  

Tel. (310) 966-1680

Fax. (310) 966-1690

 

Tenant Contact Information
1.    Lessee Full Legal Name:                                                                                                                                                                         

Office Main: (                )                                                  

  

Mobile: (                 )                                                                     

Email Address:                                                                                                                                                                           

2.    Leased Premises Address:                                                                                                                                                                       
3.    On-Site Contact Name/Title:                                                                                                                                                                  

Office Main: (                )                                                  

  

Mobile: (                 )                                                                     

Email Address:                                                                                                                                                                             

4.    Accounts Payable Contact Name:                                                                                                                                                            

Office Main: (                )                                                  

  

Mobile: (                 )                                                                     

Email Address:                                                                                                                                                                           

Mailing Address (if different):                                                                                                                                                          

Tenant Business Information

 

5.

Nature of Business:                                                                   NAICS (6-digit) Code for Business:                                                    

 

6.

Total Number of Employees at this location:                 

 

7.

Product or Service is Used by Consumers or by Other Businesses (circle one)

 

8.

Does your business engage in Ecommerce? (circle one)     YES     NO

If answer is “No” then continue to question 12

 

9.

Percent of Product or Service sold direct to consumers via the Internet                                                                                               

 

10.

Percent of Product or Service sold direct to businesses via the Internet                                                                                               

 

11.

Where does the Product/Service Originate From?                                                                                                                                  

 

12.

Percent of Product or Service that is Sourced in CA                                                                                                                              

 

13.

Percent of Product or Service that is Sourced in USA but outside CA                                                                                                   

 

14.

Percent of Product or Service that is Imported from outside USA                                                                                                         

 

15.

Where is the Product/Service distributed to?                                                                                                                                          

 

16.

Percent of Product or Service that is distributed to or consumed in CA                                                                                               

 

17.

Percent of Product or Service that is distributed to or consumed in USA, but outside of CA                                                            

 

18.

Percent of Product or Service that is exported to outside of USA                                                                                                        

 

19.

Signature:                                                                                          Date:                                                                                                   


ACKNOWLEDGEMENT OF PREMISES

 

      

 

Lessor:

 

RIF III – Avenue Stanford, LLC, a California limited liability company

 

Lessee:

 

Avita Medical Americas, LLC, a Delaware limited liability company

This Acknowledgment of Premises (this “Acknowledgment”) is made by Lessor and Lessee pursuant to that certain Standard Multi-Tenant Office Lease – Gross, dated as of October 3, 2016 (the “Lease”) for certain premises located at 28159 Avenue Stanford, Unit 220, Valencia, California, 91355, and as further described in the Lease (the “Premises”). This Acknowledgment is made pursuant to Paragraphs 1.2(a) of the Lease. Capitalized terms used herein but not defined herein shall have the meaning given them in the Lease.

1. Re-measurement of Premises. The rentable square footage of the Premises has been re-measured in accordance with Paragraph 1.2 of the Addendum to the Lease. Based on such re-measurement, the rentable square footage of the Premises is determined to be 11,809 rentable square feet. Accordingly, the Base Rent, Lessee’s Share of Common Area Operating Expenses and the Security Deposit are hereby recalculated (and the Lease is hereby amended to reflect the same) as follows:

a. Base Rent. Paragraph 1.5 of the Lease is hereby amended to provide that the Base Rent payable by Lessee during the Original Term shall be as follows:

 

Period of Original Term

   Monthly Base Rent  

From the Commencement Date to the last day of the twelfth (12th) full calendar month of the Term

   $ 19,484.85  

From the first day of the thirteenth (13th) full calendar month of the Term

   $ 20,069.40  

From the first day of the twenty-fifth (25th) full calendar month of the Term

   $ 20,671.48  

From the first day of the thirty-seventh (37th) full calendar month of the Term

   $ 21,291.62  

b. Lessee’s Share of Common Area Operating Expenses. Paragraph 1.6 of the Lease is hereby amended to provided that Lessee’s Share of Common Area Operating Expenses shall be Fourteen and Ninety-Four Hundredths percent (14.94%) (“Lessee’s Share”).

c. Security Deposit. Paragraph 1.7(c) of the Lease is hereby amended to provide that the Security Deposit shall be $63,874.86 (“Security Deposit”).


d. Base Rent and Other Monies Paid Upon Execution. Lessor and Lessee shall reconcile any discrepancy in the amounts that Lessee paid upon execution pursuant to Paragraph 1.7 of the Lease for Base Rent and the Security Deposit in order to reflect the modifications set forth in this Acknowledgment. With respect to any overpayment of such amounts by Lessee, Lessor shall have the right to apply such overpayment to future Base Rent due under the Lease or to refund such overpayment to Lessee. With respect to any underpayment of such amounts by Lessee, Lessee shall pay the difference to Lessor within fifteen (15) days after the execution of this Acknowledgment.

2. Miscellaneous. This Acknowledgment is incorporated into the Lease, and forms an integral part thereof. This Acknowledgment shall be construed and interpreted in accordance with the terms of the Lease for all purposes. Except as modified by this Acknowledgment, the Lease remains unchanged, and, as modified by this Acknowledgment, the Lease is in full force and effect. In the event of any conflict between the terms of this Acknowledgment and the Lease, this Acknowledgment shall control. This Acknowledgment may be executed in several counterparts, each of which may be deemed an original, but all of which together shall constitute one and the same Acknowledgment. In addition, properly executed, authorized signatures may be transmitted via facsimile and upon receipt shall constitute an original signature.

 

LESSOR   LESSEE

RIF III – Avenue Stanford, LLC,

a California limited liability company

 

Avita Medical Americas, LLC,

a Delaware limited liability company

By:  

Rexford Industrial Realty, L.P.,

a Maryland limited Partnership

Its Managing Member

 
  By:  

Rexford Industrial Realty, Inc.,

a Maryland corporation,

Its General Partner

 
    By: /s/ Howard Schwimmer                         By: /s/ Troy Barring                          
    Name Printed: Howard Schwimmer     Name Printed: Troy Barring
    Title: Co-Chief Executive Officer     Title: Chief operating officer
          By:                                                      
        Name Printed:                                   
        Title:                                                   
       

 


FIRST AMENDMENT TO LEASE

THIS FIRST AMENDMENT TO LEASE AGREEMENT (the Amendment”) is entered into as of the 14th day of December, 2016, by and between RIF III – AVENUE STANFORD, LLC, a California limited liability company (“Landlord”) and AVITA MEDICAL AMERICAS, LLC, a Delaware limited liability company (“Tenant”).

W I T N E S S E T H:

WHEREAS, Landlord and Tenant have entered into that certain Standard Multi-Tenant Office Lease—Gross dated October 3, 2016 (the Original Lease”), pursuant to which Landlord leased to Tenant certain premises consisting of approximately 11,825 square feet located at 28159 Avenue Stanford, Suite 220, Valencia, California 91355 (the Premises”), such Original Lease, as heretofore modified, being herein referred to as the Lease.

WHEREAS, Landlord and Tenant desire to modify the Lease to, among other things, extend the Commencement Date and the Expiration Date of the Lease, on the terms and conditions set forth below.

A G R E E M E N T:

NOW THEREFORE, in consideration of the Premises and the mutual covenants hereinafter contained, the parties hereto agree as follows:

 

  1.

Except as otherwise expressly provided herein, all defined terms used in this Amendment shall have the same respective meanings as are provided for such defined terms in the Lease.

 

  2.

The Commencement Date as set forth in Section 1.3 of the Original Lease is hereby extended to December 30, 2016.

 

  3.

The Expiration Date as set forth in Section 1.3 of the Original Lease is hereby extended to January 31, 2021.

 

  4.

The Base Rent Paid Upon Execution of the Lease as set forth in Section 1.7 (a) of the Original Lease shall be applied to the first full month of the Lease, which is January 2017. Accordingly, concurrently upon execution of this Amendment, Tenant shall deliver to Landlord payment of prorated Base Rent for the month of December in the total amount of $1,258.79.

 

  5.

Notwithstanding anything in the Original Lease to the contrary, the Base Year of the Lease shall be 2017.

 

  6.

Tenant warrants, represents and certifies to Landlord that as of the date of this Amendment, (i) Landlord is not in default under the Lease, (ii) Tenant does not have any defenses or offsets to payment of rent and performance of its obligations under the Lease as and when the same become due; and (iii) Tenant has no remaining renewal, extension or termination options or rights of first offer or first refusal.

 

  7.

Insofar as the specific terms and provisions of this Amendment purport to amend or modify or are in conflict with the specific terms, provisions and exhibits of the Lease, the terms and provisions of this Amendment shall govern and control; in all other respects, the terms, provisions and exhibits of the Lease shall remain unmodified and in full force and effect.

 

  8.

Landlord and Tenant hereby agree that (i) this Amendment is incorporated into and made a part of the Lease, (ii) any and all references to the Lease hereinafter shall include this Amendment, and (iii) the Lease and all terms, conditions and provisions of the Lease are in full force and effect as of the date hereof, except as expressly modified and amended hereinabove.


  9.

Each party hereto, and their respective successors and assigns shall be authorized to rely upon the signatures of all of the parties hereto on this Amendment which are delivered by facsimile or PDF as constituting a duly authorized, irrevocable, actual, current delivery of this Amendment with original ink signatures of each person and entity. This Amendment may be executed in counterparts, each of which shall be deemed an original part and all of which together shall constitute a single agreement.

[Signature Page Follows]


IN WITNESS WHEREOF, the parties hereto have signed this Amendment as of the day and year first above written.

 

TENANT:
AVITA MEDICAL AMERICAS, LLC,
a Delaware limited liability company
By:   /s/ Troy Barring
Name:   Troy Barring
Title:   COO

 

By:    
Name:  

 

Title:  

 

 

LANDLORD:
RIF III – AVENUE STANFORD, LLC,
a California limited liability company
By:   Rexford Industrial Realty, L.P.,
a Maryland limited partnership,
its Managing Member
By:   Rexford Industrial Realty, Inc.,
a Maryland corporation,
its General Partner
By:   /s/ Howard Schwimmer
Name:   Howard Schwimmer
Title:   Co-Chief Executive Officer


SECOND AMENDMENT TO LEASE

THIS SECOND AMENDMENT TO LEASE AGREEMENT (the Amendment) is entered into as of the 4th day of December, 2017, by and between RIF III – Avenue Stanford. LLC. a California limited liability company (“Landlord”) and Avita Medical Americas, LLC, a Delaware limited liability company (“Tenant”).

W I T N E S S E T H:

WHEREAS, Landlord and Tenant have entered into a Lease dated October 3, 2016, as amended by the First Amendment to Lease, dated as of December 14, 2016, pursuant to which Landlord leased to Tenant certain premises consisting of approximately 11,809 square feet located at 28159 Avenue Stanford, Suite 220. Valencia, California. 91355 (the “Original Premises”), such lease, as heretofore modified, being herein referred to as the “Lease”.

NOW, THEREFORE, Landlord and Tenant desire to modify the Lease to, among other things, to expand the Premises upon the terms and conditions set forth herein.

A G R E E M E N T:

NOW THEREFORE, in consideration of the Premises and the mutual covenants hereinafter contained, the parties hereto agree as follows:

 

  1.

Effective February 1, 2018 (the “Expansion Date”), the “Premises” (as defined in the Lease) shall be expanded to include that certain premises commonly known as 28159 Avenue Stanford, Suite 200, Valencia, California, 91355, comprised of an approximately 5,656 rentable square foot unit (the “Expansion Premises”). on the terms and conditions set forth in the Lease, as hereby amended. Effective upon the Expansion Date, all references in the Lease to the “Premises” shall also include the Expansion Premises, except as expressly provided in this Amendment.

 

  2.

Subject to Section 7 below, Tenant shall accept the Expansion Premises in its “as is” condition, without any representations or warranties. The taking of possession of the Expansion Premises shall be conclusive evidence that Tenant accepts the Expansion Premises and that the Expansion Premises were in good condition at the time possession was taken except for any punchlist items agreed to in writing by Landlord and Tenant pursuant to the attached Move-In/Move-Out checklist. Prior to the Expansion Date, Tenant shall deliver to Landlord a Certificate of Insurance and Endorsement for the Expansion Premises in compliance with Section 8 of the Lease. Notwithstanding the foregoing, Tenant shall be granted early possession of the Expansion Premises upon Substantial Completion of the Landlord Work (defined below), so long as (i) Tenant is not in Default under the Lease, (ii) upon full execution of this Amendment, (iii) upon Lessor’s receipt of a Certificate of Insurance and Endorsement for the Expansion Premises pursuant to Paragraph 8.2 of the Lease, and (iv) payment of total monies due as described under Paragraph 8 of this Amendment. During such early possession


  of the Expansion Premises, Tenant shall be bound by its obligations under the Lease but shall not be obligated to pay the monthly Base Rent or Common Area Operating Expenses payable by Tenant to Landlord for the Expansion Premises as set forth in the Lease, as amended by this Amendment.

 

  3.

Base Rent.

 

  a.

Tenant shall continue to pay Base Rent for the Original Premises pursuant to the Lease.

 

  b.

The term for the Expansion Premises shall commence on the Expansion Date and shall expire January 31, 2021 (the Expansion Premises Term”) The monthly Base Rent for the Expansion Premises shall be as follows:

 

Period

   Monthly Base Rent  

February 1, 2018 — January 31, 2019

   $ 10,180.80  

February 1, 2019 — January 31, 2020

   $ 10,463.60  

February 1, 2020 — January 31, 2021

   $ 10,746.40  

 

  4.

Tenant shall continue to pay Common Area Operating Expenses as provided in the Lease applicable to the Original Premises pursuant to the Lease. During the Expansion Premises Term, Tenant shall pay all increases in Common Area Operating Expenses over the Base Year, during the Expansion Premises Term. Lessee’s Share (as defined in Paragraph 1.6 of the Lease) of the Common Area Operating Expenses for the Expansion Premises is seven and fourteen hundredths percent (7.14%).

 

  5.

The “Base Year” for the Expansion Premises shall be calendar year 2018.

 

  6.

Landlord currently holds a Security Deposit for the Original Premises in the amount of $63,874.86. The Security Deposit for the Expansion Premises shall be $32,239.20 and shall be held by Landlord in accordance with the terms of Section 5 of the Lease. Upon the Expansion Date, the Security Deposit to be held by Landlord for the Premises shall be a total of $96,114.06.

 

  7.

Landlord shall, at Tenant’s sole cost and expense, on a one-time basis only, (i) construct four (4) additional offices in the Expansion Premises, as shown on Exhibit “A”, (ii) install one (1) dishwasher in a mutually agreeable location; and (iii) install two (2) 6’x8’ cased openings to connect the Original Premises with the Expansion Premises, as shown on Exhibit “A” (collectively, the Landlord Work), using Project standard materials, specification. guidelines and procedures (except to the extent otherwise designated by Landlord). The exact scope and specifications for each element of the Landlord Work shall be determined by Landlord. Landlord shall be permitted to perform the Landlord Work during Tenant’s occupancy of the Premises, during normal business hours (or any hours), without any obligation to pay overtime or other premiums. Tenant shall not (and Tenant shall ensure that its agents do not) interfere with the performance of the Landlord Work and shall cooperate with Landlord in connection with the performance of the Landlord Work, including, without limitation, by moving any equipment and other properly which Landlord or its contractor may request be moved at Tenant’s sole cost and expense. Landlord shall have no responsibility for, or for any reason be liable to Tenant for, any direct or indirect injury to or interference with


Tenant’s business arising from the performance of the Landlord Work, nor shall Tenant be entitled to any compensation or damages for loss of the use of the whole or any part of the Premises or of Tenant’s personal properly or improvements resulting from the performance of the Landlord Work or Landlord’s or Landlord’s contractor’s or agent’s actions in connection with the performance of the Landlord Work, or for any inconvenience or annoyance occasioned by the performance of the Landlord Work or Landlord’s or Landlord’s contractor’s or agent’s actions in connection with the performance of the Landlord Work. Tenant shall be responsible for any increase in the cost of performing the Landlord Work resulting from any act or omission of Tenant or its agents, employees, contractors. In addition, should Tenant request any change in the scope of the Landlord Work, then Tenant shall be responsible for all costs and expenses incurred by Landlord in connection therewith (payable upon demand); provided, however. Landlord shall have no obligation to change the scope of the Landlord Work (and any election to do so shall be in Landlord’s sole and absolute discretion).

For purposes of this Amendment, “substantial Completion” of the Expansion Premises shall occur when, in the opinion of the construction manager (whether an employee or agent of Landlord or a third-party construction manager), the Landlord Work is substantially completed except for punch list items which do not prevent in any material way the use of the Premises for the purposes for which it was intended.

The cost of The Landlord Work shall be amortized on a straight line basis over the Expansion Premises Term, which such amortization Tenant shall be required to pay to Landlord. $1,670.28 per month (the “Improvement Amortization”). The Improvement Amortization shall be subject to the same terms and conditions as Rent under the Lease.

 

  8.

Landlord shall. at Landlord’s sole cost and expense, on a one-time basis only, install vertical blinds at the Expansion Premises, similar to the blinds at the Original Premises (collectively, (the “Blind Work”). using Project standard materials. specifications, guidelines and procedures (except to the extent otherwise designated by Landlord). Landlord shall be permitted to perform the Blind Work during Tenant’s occupancy of the Premises, during normal business hours (or any hours), without any obligation to pay overtime or other premiums. Tenant shall not (and Tenant shall ensure that its agents do not) interfere with the performance of the Blind Work and shall cooperate with Landlord in connection with the performance of the Blind Work. including, without limitation, by moving any equipment and other property which Landlord or its contractor may request be moved at Tenant’s sole cost and expense Landlord shall have no responsibility for, or for any reason be liable to Tenant for, any direct or indirect injury to or interference with Tenant’s business arising from the performance of the Blind Work, nor shall Tenant be entitled to any compensation or damages for loss of the use of the whole or any part of the Premises or of Tenant’s personal property or improvements resulting from the performance of the Blind Work or Landlord’s or Landlord’s contractor’s or agent’s actions in connection with the performance of the Landlord Work, or for any inconvenience or annoyance occasioned by the performance of the Blind Work or Landlord’s or Landlord’s contractor’s or agent’s actions in connection with the performance of the Blind Work. Tenant shall be responsible for any increase in the cost of performing the Blind Work resulting from any act or omission of Tenant or its agents, employees, contractors. In addition, should Tenant request any change in the scope of the Blind Work, then Tenant shall be responsible for all costs and expenses incurred by Landlord in connection therewith (payable upon demand); provided, however. Landlord shall have no obligation to change the scope of the Blind Work (and any election to do so shall be in Landlord’s sole and absolute discretion).


  9.

Upon execution of this Amendment, a total of $44,090.28 shall be due. which is the sum of the Security Deposit for the Expansion Premises ($32,239.20), the Improvement Amortization for the calendar month of February 2018 ($1,670.28) and the Base Rent for the Expansion Premises for the calendar month of February 2018 ($10,180.80).

 

  10.

Notwithstanding anything herein to the contrary but subject to Tenant not being in default and all prior rental payments having been received by Landlord not later than the fifth (5th) of each month, the Base Rent (and only the Base Rent) applicable to the Expansion Premises only, for the calendar month of March 2018 shall be discounted by one hundred percent (100%) (the “Expansion Premises Base Rent Credit”). Tenant understands and agrees that the foregoing Expansion Premises Base Rent Credit is conditioned upon Tenant’s not being in default under this Lease. Accordingly, upon the occurrence of any default under this Lease, the foregoing Expansion Premises Base Rent Credit shall immediately become null and void, and any Base Rent previously credited to Tenant shall immediately become due and payable, and Tenant shall no longer receive any credit on account of such Expansion Premises Base Rent Credit.

 

  11.

Upon the Expansion Date, Tenant shall be entitled to the use of an additional sixteen (16) unreserved vehicle parking spaces, the use of which shall be subject to the terms and conditions of Section 2.6 of the Lease.

 

  12.

Tenant warrants, represents and certifies to Landlord that as of the date of this Amendment, (i) Landlord is not in default under the Lease, (ii) Tenant does not have any defenses or offsets to payment of rent and performance of its obligations under the Lease as and when the same become due; (iii) Tenant has not heretofore assigned or sublet all or any portion of its interest in the Lease or in the Original Premises; (iv) no other person, firm or entity has any right, title or interest in the Lease or in the Original Premises through Tenant; and (v) Tenant has the full right, legal power and actual authority to enter into this Amendment without the consent of any person, firm or entity.

 

  13.

Tenant represents and warrants that it has dealt with no broker, agent or other person in connection with this transaction and that no broker, agent or other person brought about this transaction, other than CBRE, Inc. and Tenant agrees to indemnify and hold Landlord harmless from and against any claims by any other broker, agent or other person claiming a commission or other form of compensation by virtue of having dealt with Tenant with regard to this leasing transaction.

 

  14.

Except as otherwise expressly provided herein, all defined terms used in this Amendment shall have the same respective meanings as are provided for such defined terms in the Lease. Insofar as the specific terms and provisions of this Amendment purport to amend or modify or are in conflict with the specific terms, provisions and exhibits of the Lease, the terms and provisions of this Amendment shall govern and control; in all other respects, the terms, provisions and exhibits of the Lease shall remain unmodified and in full force and effect.

 

  15.

Landlord and Tenant hereby agree that (i) this Amendment is incorporated into and made a part of the Lease, (ii) any and all references to the Lease hereinafter shall include this Amendment, and (iii) the Lease and all terms, conditions and provisions of the Lease are in full force and effect as of the date hereof, except as expressly modified and amended hereinabove.


  16.

A Certified Access Specialist (CASp) can inspect the subject premises and determine whether the subject premises comply with all of the applicable construction-related accessibility standards under state law. Although state law does not require a CASp inspection of the subject premises, the commercial property owner or Landlord may not prohibit the Tenant or tenant from obtaining a CASp inspection of the subject premises for the occupancy or potential occupancy of the Tenant or tenant, if requested by the Tenant or tenant. The parties shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the Premises.

Landlord makes the following statement based on Landlord’s actual knowledge in order to comply with California Civil Code Section 1938: The Building and the Premises have not undergone an inspection by a Certified Access Specialist (CASp). Landlord and Tenant hereby mutually agree that in the event a CASp inspection is requested by Tenant, the fee for the CASp inspection and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within and outside the Premises noted in the CASp inspection shall be paid by Tenant

 

  17.

LANDLORD HEREBY DISCLOSES TO TENANT THAT, BASED ON THE AGE OF THE BUILDING, LANDLORD HAS REASONABLE CAUSE TO BELIEVE THAT ASBESTOS-CONTAINING MATERIALS MAY BE PRESENT IN THE BUILDING AND THE PREMISES. TENANT ACKNOWLEDGES THAT LANDLORD HAS SATISFIED ITS OBLIGATION TO NOTIFY TENANT OF THE PRESENCE OF ASBESTOS-CONTAINING MATERIALS IN THE BUILDING PURSUANT TO CALIFORNIA HEALTH & SAFETY CODE SECTION 25359.7, AND TENANT SHALL NOT DISTURB ANY MATERIALS THAT MAY CONTAIN ASBESTOS.

 

  18.

Tenant agrees and understands that Landlord shall have the right (provided that the exercise of Landlord’s rights does not materially and adversely affect Tenant’s use and occupancy of the Premises or subject Tenant to additional costs, without Tenant’s consent, to place a solar electric generating system on the roof of the Building or enter into a lease for the roof of the Building whereby such roof lessee shall have the right to install a solar electric generating system on the roof of the Building, and Landlord and its agents shall have access to the roof to accomplish the foregoing.

 

  19.

Each party hereto, and their respective successors and assigns shall be authorized to rely upon the signatures of all of the parties hereto on this Amendment which are delivered by facsimile or PDF as constituting a duly authorized, irrevocable, actual, current delivery of this Amendment with original ink signatures of each person and entity. This Amendment may be executed in counterparts, each of which shall be deemed an original part and all of which together shall constitute a single agreement.

[Signature Page Follows]


IN WITNESS WHEREOF, the parties hereto have signed this Amendment as of the day and year first above written.

TENANT:

 

AVITA MEDICAL AMERICAS, LLC,
a Delaware limited liability company
By:   /s/ Timothy J. Rooney
Name: Timothy J. Rooney
Title: Chief Administrative Officer
Date: Dec 4, 2017

LANDLORD:

 

RIF III – AVENUE STANFORD, LLC,
a California limited liability company
By:   Rexford Industrial Realty, L.P.,
  a Maryland limited partnership,
  Its Managing Member
  By:   Rexford Industrial Realty, Inc.,
    a Maryland corporation,
    Its General Partner
    By:   /s/ Howard Schwimmer
    Name Printed: Howard Schwimmer
    Title: Co-Chief Executive Officer
    Date: Dec 5, 2017 | 2:22 PM PST


EXHIBIT “A”

The Landlord Work Plan

 

 

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EXHIBIT “A” CONTINUED

 

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EX-8.1

Exhibit 8.1

Subsidiaries of Avita Medical Limited

C3 Operations Pty Ltd – Australia

Avita Medical Europe Ltd – United Kingdom

Avita Medical Americas LLC – United States

Infamed Pty Limited – Australia

Visiomed Group Pty Ltd – Australia

August 22, 2019

 

1

EX-15.1

Exhibit 15.1

 

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Preliminary Final Report

30 June 2019

AVITA MEDICAL LIMITED

ABN 28 058 466 523

Results for announcement to the market

 

     Movement     June 2019      June 2018  

Financial Results

       A$        A$  

Sale of goods

     Up 543     7,705,398        1,198,861  

Other income

     Down 8     9,326,520        10,172,698  

Loss for the period attributable to owners of the parent

     Up 109     34,603,141        16,519,155  

Total comprehensive loss attributable to owners of the parent

     Up 106     32,819,919        15,955,876  

 

Dividends

   Amount per Ordinary
Security
   Franked amount
per security

2018 interim dividend

   Nil    Nil

2017 interim dividend

   Nil    Nil

Record date for determining entitlements to interim dividends

  

N/A

Net Tangible Asset Backing

   June 2019    June 2018

Net tangible asset backing per ordinary security

   A$0.0161    A$0.0149

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENTS OF PROFIT OR LOSS AND OTHER COMPREHENSIVE INCOME

FOR THE YEAR ENDED 30 JUNE 2019

 

     Note      2019     2018  

Continuing operations

       

Sale of goods

     2      A$ 7,705,398     A$ 1,198,861  

Cost of sales

        (1,697,823     (511,646
     

 

 

   

 

 

 

Gross profit

        6,007,575       687,215  

BARDA income

     2        8,259,152       10,104,081  

Other income

     2        1,067,368       68,617  
     

 

 

   

 

 

 

Total other income

        9,326,520       10,172,698  

Operating costs

       

Sales and marketing expenses

        (17,576,754     (8,936,441

Corporate and administrative expenses

        (15,398,176     (5,360,553

Product development expenses

        (14,361,995     (12,606,127

Share-based payment expenses

        (2,742,405     (1,835,157

Finance costs

        (37,769     (26,586
     

 

 

   

 

 

 

Total operating costs

        (50,117,099     (28,764,864
     

 

 

   

 

 

 

Loss from continuing operations before income tax benefit

        (34,783,004     (17,904,951

Income tax benefit (net)

        179,863       1,385,796  
     

 

 

   

 

 

 

Loss for the period

        (34,603,141     (16,519,155

Other comprehensive income

       

Items that may be reclassified subsequently to profit and loss:

       

Foreign currency translation

        1,783,222       563,279  
     

 

 

   

 

 

 

Other comprehensive income for the period, net of tax

        1,783,222       563,279  
     

 

 

   

 

 

 

Total other comprehensive loss for the period

      A$ (32,819,919   A$ (15,955,876
     

 

 

   

 

 

 

Loss for the period attributable to owners of the parent

        (34,603,141     (16,519,155
     

 

 

   

 

 

 

Total comprehensive loss attributable to owners of the parent

      A$ (32,819,919   A$ (15,955,876
     

 

 

   

 

 

 

Basic loss per share attributable to ordinary equity holders of the parent

      A$ (2.73) cents     A$ (1.77) cents  

Diluted loss per share attributable to ordinary equity holders of the parent

      A$ (2.73) cents     A$ (1.77) cents  

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

AS AT 30 JUNE 2019

 

     Notes      2019     2018  

ASSETS

       

Current assets

       

Cash and cash equivalents

      A$ 28,983,491     A$ 14,825,532  

Trade and other receivables

     3        2,980,102       5,437,357  

Prepayments and other assets

        1,557,525       855,716  

Inventories

     4        1,057,764       1,155,826  
     

 

 

   

 

 

 

Total current assets

        34,578,882       22,274,431  
     

 

 

   

 

 

 

Non-current assets

       

Plant and equipment

        1,838,515       742,583  

Patents-in-progress

        320,676       —    
     

 

 

   

 

 

 

Total non-current assets

        2,159,191       742,583  
     

 

 

   

 

 

 

TOTAL ASSETS

      A$ 36,738,073     A$ 23,017,014  
     

 

 

   

 

 

 

LIABILITIES

       

Current liabilities

       

Trade and other payables

        5,633,562       3,487,582  

Provisions

        650,359       395,535  
     

 

 

   

 

 

 

Total current liabilities

        6,283,921       3,883,117  
     

 

 

   

 

 

 

Non-current liabilities

       

Finance lease

        54,057       134,338  

Total non-current liabilities

        54,057       134,338  
     

 

 

   

 

 

 

TOTAL LIABILITIES

      A$ 6,337,978     A$ 4,017,455  
     

 

 

   

 

 

 

NET ASSETS

      A$ 30,400,095     A$ 18,999,559  
     

 

 

   

 

 

 

EQUITY

       

Equity attributable to equity holders of the parent:

       

Contributed equity

     5        204,279,078       162,801,028  

Accumulated losses

        (183,196,020     (148,592,879

Reserves

        9,317,037       4,791,410  
     

 

 

   

 

 

 

TOTAL EQUITY

      A$ 30,400,095     A$ 18,999,559  
     

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE YEAR ENDED 30 JUNE 2019

 

     2019     2018  

Cash flows from operating activities

    

Payments to suppliers and employees

   A$  (47,030,980   A$  (25,681,347

Interest paid

     —         (26,586

BARDA receipts and other income received

     10,827,561       8,141,207  

Receipts from customers

     5,826,634       1,129,046  

R&D tax refund received

     2,440,803       —    

Interest received

     450,323       65,656  
  

 

 

   

 

 

 

Net cash flows used in operating activities

     (27,485,659     (16,372,024
  

 

 

   

 

 

 

Cash flows from investing activities

    

Payments for plant and equipment

     (1,473,934     (498,749

Payments for intellectual property

     (320,676     —    
  

 

 

   

 

 

 

Net cash flows used in investing activities

     (1,794,610     (498,749
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from issuance of shares and options

     45,036,886       29,760,563  

Proceeds from exercise of share options

     452,809       —    

Capital raising expenses

     (4,192,519     (1,825,643
  

 

 

   

 

 

 

Net cash flows provided by financing activities

     41,297,176       27,934,920  
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     12,016,907       11,064,147  

Cash and cash equivalents at beginning of period

     14,825,532       3,790,491  

Impact of foreign exchange

     2,141,052       (29,106
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   A$ 28,983,491     A$ 14,825,532  
  

 

 

   

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

FOR THE YEAR ENDED 30 JUNE 2019

 

     Contributed
equity
    Accumulated losses     Share-based
payment reserve
    Foreign currency
translation
reserve
     Total  
At 1 July 2018    A$ 162,801,028     A$ (148,592,879)     A$ 4,505,148     A$ 286,262      A$ 18,999,559  

Loss for the period

     —         (34,603,141     —         —          (34,603,141

Other comprehensive income

           

Foreign currency translation

     —         —         —         1,783,222        1,783,222  
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

Total comprehensive loss for the year

     —         (34,603,141     —         1,783,222        (32,819,919
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

Transactions with owners in their capacity as owners

           

Expired options

     —         —         (32,362     —          (32,362

Share based payments

     —         —         2,774,767       —          2,774,767  

New shares

     45,580,570       —         —         —          45,580,570  

Cost of share placement

     (4,102,520     —         —         —          (4,102,520
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 
Balance at 30 June 2019    A$ 204,279,078     A$ (183,196,020)     A$ 7,247,553     A$ 2,069,484      A$ 30,400,095  
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

FOR THE YEAR ENDED 30 JUNE 2018

 

     Contributed
equity
    Accumulated
losses
    Share-based
payment reserve
    Foreign currency
translation reserve
     Total  
At 1 July 2017    A$ 134,806,022     A$ (132,218,352)     A$ 2,811,179     A$ (277,017)      A$ 5,121,832  

Loss for the period

     —         (16,519,155     —         —          (16,519,155

Other comprehensive income

           

Foreign currency translation

     —         —         —         563,279        563,279  
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

Total comprehensive loss for the year

     —         (16,519,155     —         563,279        (15,955,876
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

Transactions with owners in their capacity as owners:

           

Expired options

     —         141,188       (141,188     —          —    

Forfeiture options

     —         3,440       (31,832     —          (28,392

Share based payments

     —         —         1,866,989       —          1,866,989  

New shares

     29,846,859       —         —         —          29,846,859  

Cost of share placement

     (1,851,853     —         —         —          (1,851,853
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 
Balance at 30 June 2018    A$ 162,801,028     A$ (148,592,879)     A$ 4,505,148     A$ 286,262      A$ 18,999,559  
  

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

The accompanying notes form part of the consolidated financial statements.

 

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AVITA MEDICAL LIMITED

NOTES TO THE PRELIMINARY FINAL REPORT

FOR THE YEAR ENDED 30 JUNE 2019

 

1.

BASIS OF PREPARATION AND ACCOUNTING POLICIES

Basis of Preparation

Avita Medical Limited (“Company”) is incorporated in Australia and is a for-profit entity for purposes of preparing the consolidated financial statements. The financial statements for the consolidated entity which consists of Avita Medical Limited and its subsidiaries (collectively referred to as the “Group”) for the year ended 30 June 2019 were authorized for issue by the Board of Directors on 30 August 2019.

The consolidated financial statements are general purpose consolidated financial statements that:

 

   

have been prepared in accordance with the requirements of the Corporations Act 2001 of International Financial Reporting Standards (“IFRS”);

 

   

include the assets and liabilities of the Group as of 30 June 2019 and the results of the subsidiaries for the year then ended. Inter-entity transactions with, or between, subsidiaries are eliminated in full on consolidation;

 

   

have been prepared on a historical cost basis;

 

   

are measured and presented in Australian dollars which is ASX’s functional and presentation currency.

The preliminary financial report does not include all notes of the type normally included within the annual financial report and therefore cannot be expected to provide a full understanding of the financial performance, financial position and financing and investing activities of the consolidated entity as the full financial report. Accordingly, this report is to be read in conjunction with the accompanying notes, the 2018 Annual Report, the 2018 Annual Financial Statements and any public announcements made by Avita Medical Limited in accordance with the continuous disclosure obligations of the ASX listing rules.

This financial report has been prepared on the going concern basis. The accounting policies have been applied consistently throughout the Group for the purposes of preparation of the consolidated financial statements.

Commentary on the results for the period

Avita Medical Limited and its subsidiaries are a regenerative medicine company with a technology platform designed to address unmet medical needs in patients with burns, chronic wounds, and aesthetics indications. The Company’s patented and proprietary collection and application technology provides innovative treatment solutions derived from the regenerative properties of a patient’s own skin. The Company’s medical devices work by preparing a Regenerative Epidermal Suspension (RES), an autologous suspension comprised of the patient’s own skin cells that are necessary to regenerate natural healthy epidermis. This autologous suspension is then sprayed onto the areas of the patient requiring treatment. The first medical device based on the RES technology, the RECELL® System, was approved for sale in the U.S. for the treatment of acute thermal burns in patients 18 and older by the Food and Drug Administration (FDA) in September 2018. The Company initiated its U.S. national market launch of the RECELL System in January 2019, although it did commence commercial shipments in the U.S. during the half-year ended 31 December 2018 in response to pre-launch demand from burn centers. The RECELL System is also sold on a limited basis in certain regions of the world in which the products are approved for sale, including Australia, China and Europe.

Sale of goods of the RECELL System totaled $7,705,398 for the year ended 30 June 2019, an increase of $6,506,537 or 543% over the $1,198,861 recognized during fiscal 2018. The majority of the current fiscal year increase in sales occurred in the U.S. as a result of the September 2018 FDA approval and commencement of the U.S. national market launch of the RECELL System in January 2019. U.S. sales during the fiscal year ended 30 June 2019 totaled $6,214,660 compared to zero in the prior fiscal year. Gross margin for the fiscal year ended 30 June 2019 was 78% compared to 57% for the same period in 2018, and management expects gross margins to further increase as sales ramp up within the U.S.

Other income totaled $9,326,520 for the year ended 30 June 2019, a decrease of $846,178 or 8% over the $10,172,698 recognized during fiscal 2018. As in prior periods, the majority of other income consisted of funding from the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response, within the U.S. Department of Health and Human Services, under ongoing USG Contract No. HHSO100201500028C. Under the BARDA contract, income of $8,259,152 was recognized during the year ended 30 June 2019 compared to income of $10,104,081 for fiscal 2018. The decrease was the result of wind-down of certain activities associated with supporting the U.S. FDA approval of the RECELL System as well as the compassionate use and continued access programs.

 

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Operations for the first half of the fiscal year ended 30 June 2019 were focused primarily on preparation for the January 2019 U.S. market launch of the RECELL System. Sales and marketing expenses for the year ended 30 June 2019 totaled $17,576,754, an increase of $8,640,313 or 97% over the $8,936,441 recognized during fiscal 2018. This increase was primarily attributed to the recruitment, hiring and training of a U.S. sales force and the associated product launch sales and marketing materials and activities. Product development expenses for the fiscal 2019 totaled $14,361,995 an increase of $1,755,868 or 14% over the $12,606,127 recognized during fiscal 2018. Corporate and administrative expenses totaled $15,398,176 for the year ended 30 June 2019, an increase of $10,037,623 or 187% over the $5,360,553 recognized during fiscal 2018. As the result of investments in commercial, manufacturing, and system capabilities for the U.S. market launch of the RECELL System and related initiatives, operating costs for the year ended 30 June 2019 totaled $50,117,099, a $21,352,235 or 74% increase over the $28,764,864 incurred during fiscal 2018 and were in line with management expectations.

Net comprehensive loss after tax for the fiscal year ended 30 June 2019 was $32,819,919, an increase of $16,864,043 or 106% over $15,955,876 recognized during fiscal 2018. The increase in net comprehensive loss was driven by the higher operating costs described above, partially offset by the higher sale of goods during the fiscal year. As a result of the U.S. national launch of the RECELL System in January 2019, and the expansion of research and development, operating expenses will increase in future periods. These expenses are expected to be partially offset by increased sales of goods and income under the BARDA contract.

During the year ended 30 June 2019, the net cash provided by the issuance of shares and employee stock options exercised were $40,844,367 and $452,809, respectively. Cash and cash equivalents held at 30 June 2019 was $28,983,491 an increase of $14,157,959 or 95% over $14,825,532 recognized during fiscal 2018. The increase in cash and cash equivalents was driven by the institutional placement of shares and employee stock options exercised, partially offset by the operating costs during the fiscal year. Future cash requirement will be dependent upon the success of AVITA Medical’s efforts to commercialize the RECELL System, particularly in the U.S., and the timing and magnitude of clinical and other research and development programs the Company elects to undertake to expand its product pipeline. Until such time that the Company generates sufficient cash flow from operations, it expects to fund its future cash requirements through a combination of the issuance of shares and possible debt financing.

 

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AVITA MEDICAL LIMITED

NOTES TO THE PRELIMINARY FINAL REPORT

FOR THE YEAR ENDED 30 JUNE 2019

 

2.

REVENUES AND EXPENSES

Revenue and Expenses from Continuing Operations

 

     2019      2018  

(a) Revenue

     

Sale of goods

   A$ 7,705,398      A$ 1,198,861  

(b) Other income

     

BARDA income

     8,259,152        10,104,081  

Other income

     1,067,368        68,617  
  

 

 

    

 

 

 

Total other income

   A$ 9,326,520      A$ 10,172,698  
  

 

 

    

 

 

 

(c) Employee benefits expense

     

Salaries and wages

   A$  15,472,511      A$ 8,057,869  

Share-based expenses

     2,742,405        1,835,157  

Defined contribution superannuation expense

     831,558        374,435  
  

 

 

    

 

 

 
   A$ 19,046,474      A$  10,267,461  
  

 

 

    

 

 

 

 

3.

CURRENT ASSETS - TRADE AND OTHER RECEIVABLES

 

     2019      2018  

Trade receivables

   A$ 2,143,889      A$ 263,421  

Allowance for doubtful debts

     (25,155      (23,452
  

 

 

    

 

 

 
     2,118,734        239,969  

R & D tax claim

     179,863        2,434,430  

BARDA and other receivables

     681,505        2,762,958  
  

 

 

    

 

 

 

Carrying amount of trade and other receivables

   A$  $2,980,102      A$  5,437,357  
  

 

 

    

 

 

 

 

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AVITA MEDICAL LIMITED

NOTES TO THE PRELIMINARY FINAL REPORT

FOR THE YEAR ENDED 30 JUNE 2019

 

4.

CURRENT ASSETS - INVENTORIES

 

     Consolidated  
     2019      2018  

Raw materials and components at cost

   A$  869,016      A$  778,947  

Finished goods at cost

     188,748        376,879  
  

 

 

    

 

 

 

Total inventories at cost

   A$  1,057,764      A$  1,155,826  
  

 

 

    

 

 

 

 

5.

CONTRIBUTED EQUITY

 

     2019      2018  

Ordinary shares

     

Issued and fully paid

   A$ 204,279,078      A$  162,801,028  
  

 

 

    

 

 

 
   A$ 204,279,078      A$ 162,801,028  
  

 

 

    

 

 

 
Movement in ordinary shares on issue    Number of
shares
     Amount  

At 1 July 2018

     1,277,378,325      A$ 162,801,028  

New shares

     593,921,250        45,580,570  

Capital issue costs

     —          (4,102,520
  

 

 

    

 

 

 

At 30 June 2019

     1,871,299,575      A$ 204,279,078  
  

 

 

    

 

 

 

 

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Compliance statement

 

1   This report has been prepared in accordance with AASB Standards, other AASB authoritative pronouncements and IFRS.
2   This report, and the accounts upon which the report is based (if separate), use the same accounting policies.
3   This report does give a true and fair view of the matters disclosed
4   This report is based on accounts to which one of the following applies.
      (Tick one)         
    The accounts have been audited.      The accounts have been subject to review.
    The accounts are in the process of being audited or subject to review.      The accounts have not yet been audited or reviewed.
5   The entity has a formally constituted audit committee.

Sign here:

Date: 30 August 2019

 

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Timothy Rooney

Chief Administrative Officer and Interim Chief Financial Officer

 

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