Table of Contents

 

 

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

 

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

For the fiscal year ended June 30, 2016

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 001-35428

 

 

Prima BioMed Ltd

(Exact name of Registrant as specified in its charter and translation of Registrant’s name into English)

 

 

Australia

(Jurisdiction of incorporation or organization)

Level 12, 95 Pitt Street, Sydney 2000, New South Wales, Australia

(Address of principal executive offices)

Marc Voigt, Chief Executive Officer

Level 12, 95 Pitt Street, Sydney, 2000 New South Wales, Australia

Phone +61 (0)2 8315 7003 Fax:+61 (0)2 8569 1880


Table of Contents

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

 

Title of each class

 

Name of each exchange on which registered

Ordinary Shares   NASDAQ Global Market (for listing purposes only)
American Depositary Shares, each representing 30 Ordinary Shares   NASDAQ Global Market

 

 

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 outstanding as of June 30, 2016 was 2,061,633,944.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.     ¨   Yes     x   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     x   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.     x   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   x

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   x

  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     x   No

 

 

 


Table of Contents

TABLE OF CONTENTS

 

          PAGE  
INTRODUCTION      1   
PART I      1   
Item 1   

Identity of Directors, Senior Management and Advisers

     1   
Item 2   

Offer Statistics and Expected Timetable

     1   
Item 3   

Key Information

     1   
  

A. Selected Financial Data

     1   
  

B. Capitalization and Indebtedness

     3   
  

C. Reasons for the Offer and Use of Proceeds

     3   
  

D. Risk Factors

     3   
Item 4.   

Information on the Company

     20   
  

A. History and Development of the Company

     20   
  

B. Business Overview

     24   
  

C. Organizational Structure

     33   
  

D. Property, Plants and Equipment

     33   
Item 4A.   

Unresolved Staff Comments

     33   
Item 5.   

Operating and Financial Review and Prospects

     34   
  

A. Operating Results

     34   
  

B. Liquidity and Capital Resources

     38   
  

C. Research and Development, Patents and Licenses

     40   
  

D. Trend Information

     40   
  

E. Off-Balance Sheet Arrangements

     40   
  

F. Tabular Disclosure of Contractual Obligations

     41   
  

G. Safe Harbor

     41   
Item 6.   

Directors, Senior Management and Employees

     42   
  

A. Directors and Senior Management

     42   
  

B. Compensation

     43   
  

C. Board Practices

     49   
  

D. Employees

     52   
  

E. Share Ownership

     53   
Item 7.   

Major Shareholders and Related Party Transactions

     53   
  

A. Major Shareholders

     53   
  

B. Related Party Transactions

     54   
  

C. Interests of Experts and Counsel

     54   
Item 8.   

Financial Information

     54   
  

A. Consolidated Statements and Other Financial Information

     54   
  

B. Significant Changes

     54   
Item 9.   

The Offer and Listing

     55   
  

A. Offer and Listing Details

     55   
  

B. Plan of Distribution

     55   
  

C. Markets

     55   
  

D. Selling Shareholders

     55   
  

E. Dilution

     55   
  

F. Expenses of the Issue

     56   
Item 10.   

Additional Information

     56   
  

A. Share Capital

     56   
  

B. Memorandum and Articles of Association

     56   

 

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          PAGE  
  

C. Material Contracts

     57   
  

D. Exchange Controls

     57   
  

E. Taxation

     58   
  

F. Dividends and Paying Agents

     63   
  

G. Statement by Experts

     63   
  

H. Documents on Display

     63   
  

 I. Subsidiary Information

     64   
Item 11.   

Quantitative and Qualitative Disclosures About Market Risk

     64   
Item 12.   

Description of Securities Other than Equity Securities

     64   
  

A. Debt Securities

     64   
  

B. Warrants and Rights

     64   
  

C. Other Securities

     65   
  

D. American Depositary Shares

     65   
PART II      
Item 13.   

Defaults, Dividend Arrearages and Delinquencies

     66   
Item 14.   

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

     66   
Item 15.   

Controls and Procedures

     66   
Item 15T.   

Controls and Procedures

     66   
Item 16.   

Reserved

     66   
Item 16A.   

Audit Committee Financial Expert

     66   
Item 16B.   

Code of Ethics

     67   
Item 16C.   

Principal Accountant Fees and Services

     67   
Item 16D.   

Exemptions from the Listing Standards for Audit Committees

     67   
Item 16E.   

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

     68   
Item 16F.   

Change in Registrant’s Certifying Accountant

     68   
Item 16G.   

Corporate Governance

     68   
Item 16H.   

Mine Safety Disclosure

     68   
PART III      
Item 17.   

Financial Statements

     68   
Item 18.   

Financial Statements

     68   
Item 19.   

Exhibits

  

 

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INTRODUCTION

Prima BioMed Ltd was incorporated under the laws of the Commonwealth of Australia on May 21, 1987. The principal listing of our ordinary shares and listed options to purchase our ordinary shares is the Australian Securities Exchange, or ASX. We filed a registration statement on Form 20-F with the U.S. Securities Exchange Commission that was declared effective on April 12, 2012 and our American Depositary Shares, or ADSs, were listed on the NASDAQ Global Market, or NASDAQ, under the symbol “PBMD” on April 16, 2012. The Bank of New York Mellon acts as our depositary, and registers and delivers our ADSs, each of which represents 30 of our ordinary shares. As used in this Annual Report on Form 20-F, the terms “we,” “us,” “our”, “Prima BioMed”, “Prima” and the “Company” mean Prima BioMed Ltd and its subsidiaries, unless otherwise indicated.

FINANCIAL AND OTHER INFORMATION

Our consolidated financial statements appearing in this Annual Report 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 Annual Report on Form 20-F comply with both the IFRS and Australian Accounting Standards. In this Annual Report, all references to “U.S. dollars” or “US$” are to the currency of the United States, all references to “euro”, “€” or “EUR” are to the currency of certain states of the European Union, and all references to “Australian dollars” or “$” or “A$” are to the currency of Australia.

Statements made in this Annual Report on Form 20-F concerning the contents of any contract, agreement or other document 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 Annual Report or to any registration statement that we previously filed, you may read the document itself for a complete description of its terms.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Except for the historical information contained in this Annual Report on Form 20-F, the statements contained in this Annual Report 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, 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.”

PART I

 

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS

Not applicable.

 

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE

Not applicable.

 

ITEM 3. KEY INFORMATION

A. Selected Financial Data

Our consolidated financial statements appearing in this Annual Report on Form 20-F comply with both the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, and Australian Accounting Standards, as issued by the Australian Accounting Standards Board (“AASB”).

The following selected consolidated financial data as of June 30, 2016 and 2015 and for the fiscal years ended June 30, 2016, 2015 and 2014 have been derived from our audited consolidated financial statements and notes thereto included elsewhere in this Annual Report on Form 20-F. The selected consolidated financial data as of June 30, 2014, 2013, and 2012 and for the fiscal years ended June 30, 2013 and 2012 have been derived from our audited consolidated financial statements and notes thereto which are not included in this Annual Report on Form 20-F. This data should be read together with, and is qualified in its entirety by reference to, “Item 5. Operating and Financial Review and Prospects” as well as our consolidated financial statements and notes thereto appearing in “Item 18. Financial Statements” of this Annual Report on Form 20-F.

The selected financial data are presented in Australian dollars (A$) (except as otherwise noted).

 

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Consolidated Statement of Operations Data:

 

     Year Ended June 30,  
     2016     2015     2014     2013     2012  
     (in A$, except share amounts)  

License revenue

     175,052        —         —          —          —     

Other income

     1,853,869        2,092,867        3,140,066        4,005,394        4,202,567   

Depreciation & amortization

     (1,993,093     (1,341,202     (446,360     (254,024     (377,299

Research & development and intellectual property

     (7,059,528     (8,952,447     (11,930,857     (14,005,259     (15,118,816

Corporate administrative expenses

     (6,982,629     (5,723,106     (4,092,623     (4,851,195     (5,977,619

Loss on foreign exchange

     (563,890     —          —          —          (1,181,049

Finance costs

     (8,199     (18,364,804 )     —          —          —     

Impairment of assets

     —          —          —          —          —     

Share Based Payment to strategic investor

     (47,468,071     —          —          —          —     

Changes in fair value of derivative financial instruments

     —          —          —          (33,714     (1,488,744

Net loss on financial liabilities at fair value through profit or loss

     —          —          —          —          —     

Changes in fair value of comparability milestone

     (542,075     —          —          —          —     

Net change in fair value of convertible note liability

     (607,637     —          —          —          —     

Loss on disposal of assets

     —          (5,160     —          —          —     

Loss before income tax expense

     (63,196,201     (32,293,852     (13,329,774     (15,138,798     (15,138,798

Income tax expense

     1,181,017        142,156       (13,607     (86,873     —     
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

     (62,015,184     (32,151,696     (13,343,381     (15,225,671     (19,940,960
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Loss per share – basic and diluted (in A$ cents)

     (2.77     (2.02     (0.93     (1.42     (1.92
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average number of ordinary shares outstanding – basic and diluted

     2,236,250,813        1,591,116,220        1,439,768,245        1,075,381,168        1,037,618,752   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated Balance Sheet Data:

 

     As of June 30,  
     2016      2015      2014      2013      2012  
     (in A$)  

Cash and cash equivalents

     20,879,548         6,759,615         14,200,042         22,023,143         16,991,716   

Working capital

     20,198,827         3,643,408         21,912,972         28,248,167         36,458,512   

Total assets

     42,554,067         30,983,445         25,377,955         32,814,298         41,612,671   

Long-term debt

     5,027,168         —           —           —           —     

Total shareholders’ equity

     35,317,513         24,689,743         22,592,320         29,248,418         37,157,871   

Contributed equity

     194,530,932         179,878,436         149,014,372         142,326,977         136,712,525   

Exchange Rate Information:

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 the historical daily exchange rates of the Australian dollar by the Reserve Bank of Australia (RBA).

Exchange rate as of September 30, 2016: A$1.00 is US$0.7630.

 

Year Ended June 30,

   At Period End      Average Rate      High      Low  
     US$      US$      US$      US$  

2012

     1.0191         1.0319         1.1055         0.9500   

2013

     0.9275         1.0271         1.0593         0.9202   

2014

     0.9420         0.9187         0.9672         0.8716   

2015

     0.7680         0.8382         0.9458         0.7114   

2016

     0.7426         0.7283         0.7812         0.6867   

 

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Month

   High      Low  
     US$      US$  

April 2016

     0.7812         0.7535   

May 2016

     0.7607         0.7160   

June 2016

     0.7533         0.7239   

July 2016

     0.7626         0.7436   

August 2016

     0.7711         0.7514   

September 2016

     0.7698         0.7469   

B. Capitalization and Indebtedness

Not applicable.

C. Reasons for the Offer and Use of Proceeds

Not applicable.

D. Risk Factors

The following risks relate specifically to our business and should be considered carefully. Our business, financial condition and results of operations could be harmed by any of the following risks. As a result, the trading price of our ordinary shares and our American Depositary Shares, or ADSs, could decline and the holders could lose part or all of their investment.

Risks Related to Our Business

We have a history of operating losses and may not achieve or maintain profitability in the future.

We are at an early stage in the development of pharmaceutical products and their success is therefore uncertain. We focus on the development of immunotherapeutic products for the treatment of cancer. We, and our partners, have three products under development-IMP321, IMP701 and IMP731, all of which are directed to lymphocyte activation gene 3, or LAG-3, a gene linked to the regulation of T cells in immune responses. In prior years, our business was focused on the development of CVac™, an autologous dendritic cell cancer vaccine. However, in February 2015, we suspended the development of CVac™ during its Phase II clinical trials in favor of focusing on biologicals like IMP321, which offer greater commercial potential based on cost of goods alone. While the decision to consolidate the CVac™ clinical trial program and to cease the patient recruitment has led to a significant decrease of costs, the clinical trial program of IMP321 will generate new expenses, especially as two clinical trials have been started (AIPAC and TACTI-mel). There can also be no guarantee that IMP321 will successfully be partnered or that any of our product candidates or know how, whether partnered or not, will ever generate future revenues. At this point, none of our products generate significant revenue.

For the years ended June 30, 2015 and 2016, we had a net loss of approximately $32.2 million and $62.0 million, respectively. The significant increase in net loss for the year ended June 30, 2016 was primarily attributable to a share based payment to a strategic investor of $47.5 million incurred in the issue of a convertible note and warrants to Ridgeback Capital Investments. In addition, since the year ended June 30, 2014, our total other income has continued to decrease. For the year ended June 30, 2014, total other income was approximately $3.1 million. For the year ended June 30, 2015, total other income was approximately $2.1 million, with such decrease being primarily attributable to fluctuations in foreign exchange rates. For the year ended June 30, 2016, total other income was approximately $2.0 million, with such decrease being primarily attributable to a decrease in grant income.

We will continue to incur losses from operations and expect the costs of drug development to increase in the future as more patients are recruited to the planned trials. In particular, we will continue to incur significant losses in carrying out clinical trials of IMP321 necessary for regulatory approval and ongoing research in terms of immunotherapy product candidates. Because of the numerous risks and uncertainties associated with the development, manufacturing, sales and marketing of therapeutic products, we may experience larger than expected future losses and may never become profitable.

 

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There is a substantial risk that we, or our development partners, may not be able to complete the development of our current product candidates or develop other pharmaceutical products. It is possible that none of them will be successfully commercialized, which would prevent us from ever achieving profitability.

We have no medicinal products approved for commercial sale and no source of material revenue.

Currently, we have no products approved for commercial sale and to date have not generated material revenue from product sales. We are largely dependent on the success of our product candidates, especially the LAG-3 related ones.

The LAG 3 product candidates were acquired by us through the acquisition of the French privately owned and venture capital backed company Immutep SA, a biopharmaceutical company in the rapidly growing field of Immuno-Oncology in December 2014. This acquisition significantly expanded Prima’s clinical development product portfolio to other categories of immunotherapies. It has also provided Prima with partnerships with several of the world’s largest pharmaceutical companies.

We have three LAG-3 product candidates. The most advanced of the three is IMP321. IMP321 is a recombinant protein typically used in conjunction with chemotherapy to amplify a patient’s immune response. The development and manufacturing of IMP321 is being conducted in conjunction with Eddingpharm.

Another LAG-3 product candidate is IMP701, an antagonist antibody that acts to stimulate T cell proliferation in cancer patients. IMP701 has been licensed to CoStim (Novartis), which is solely responsible for its development and manufacturing.

Our third LAG-3 product candidate is IMP731, a depleting antibody that removes T cells involved in autoimmunity. IMP731 has been licensed to GlaxoSmithKline, or GSK, which is solely responsible for its development and manufacturing.

In addition to these products Immutep also has a dedicated R&D laboratory outside Paris with other research candidates in development. Immutep also currently generates modest revenues from sales of LAG-3 research reagents.

There can be no assurance that our ability to develop any product candidate, will be successful or our ability to obtain the necessary regulatory approvals with respect to any of the foregoing will be successful.

We anticipate that as the costs related to the clinical trials for IMP321 will increase, we will require additional funds to achieve our long-term goals of commercialization and further development of IMP321 and other product candidates. In addition, we will require funds to pursue regulatory applications, defend intellectual property rights, increase contracted manufacturing capacity, potentially develop marketing and sales capability and fund operating expenses. We intend to seek such additional funding through public or private financings and/or through licensing of our assets or other arrangements with corporate partners. However, such financing, licensing opportunities or other arrangements may not be available from any sources on acceptable terms, or at all. Any shortfall in funding could result in us having to curtail or cease our operations including research and development activities, thereby harming our business, financial condition and results of operations.

Our ability to generate product revenue depends on a number of factors, including our ability to:

 

    successfully complete clinical development of, and receive regulatory approval for, our product candidates;
    set an acceptable price for our products, if approved, and obtain adequate coverage and reimbursement from third-party payors;
    obtain commercial quantities of our products, if approved, at acceptable cost levels; and
    successfully market and sell our products, if approved.

In addition, because of the numerous risks and uncertainties associated with product candidate development, we are unable to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability. Our expenses could increase beyond current expectations if the applicable regulatory authorities require further studies in addition to those currently anticipated and even if our product candidates are approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of such products and there can be no guarantee that we will ever generate significant revenues.

 

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We will require additional financing and may be unable to raise sufficient capital, which could have a material impact on our research and development programs or commercialization of our products or product candidates.

We have historically devoted most of our financial resources to research and development, including pre-clinical and clinical development activities. To date, we have financed a significant amount of our operations through public and private financings. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings or strategic collaborations. The amount of such future net losses, as well as the possibility of future profitability, will also depend on our success in developing and commercializing products that generate significant revenue. Our failure to become and remain profitable would depress the value of our ordinary shares or ADSs and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations.

We anticipate that our expenses will increase substantially for the foreseeable future if, and as, we:

 

    continue our research and preclinical and clinical development of our product candidates;

 

    expand the scope of our current proposed clinical studies for our product candidates;

 

    initiate additional preclinical, clinical or other studies for our product candidates;

 

    change or add additional manufacturers or suppliers;

 

    seek regulatory and marketing approvals for our product candidates that successfully complete clinical studies;

 

    seek to identify and validate additional product candidates;

 

    acquire or in-license other product candidates and technologies;

 

    maintain, protect and expand our intellectual property portfolio;

 

    attract and retain skilled personnel;

 

    create additional infrastructure to support our operations as a publicly quoted company and our product development and planned future commercialization efforts;

 

    add an internal sales force; and

 

    experience any delays or encounter issues with any of the above.

Until our products become commercially available, we will need to obtain additional funding in connection with the further development of our products and product candidates. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment. As such, additional financing may not be available to us when needed, on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts or obtain funds by entering agreements on unattractive terms. Our resource allocation decisions and the elimination of development programs may result in the failure to capitalize on profitable market opportunities. Furthermore, any additional equity fundraising in the capital markets may be dilutive for stockholders and any debt-based funding may bind us to restrictive covenants and curb our operating activities and ability to pay potential future dividends even when profitable. We cannot guarantee that future financing will be available in sufficient amounts or on acceptable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we will be prevented from pursuing research and development efforts. This could harm our business, operating results and financial condition and cause the price of our common stock to fall.

If we are unable to secure sufficient capital to fund our operations, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. For example, additional strategic collaborations could require us to share commercial rights to our product candidates with third parties in ways that we do not intend currently or on terms that may not be favorable to us. Moreover, we may also have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us.

We are exposed to significant risks related to our ongoing research and development efforts and might not be in a position to successfully develop any product candidate. Any failure to implement our business strategy could negatively impact our business, financial condition and results of operations.

The development and commercialization of IMP321, IMP701 and IMP731, or any other product candidate we may develop, is subject to many risks, including:

 

    additional clinical trials may be required beyond what we currently expect;

 

    regulatory authorities may disagree with our interpretation of data from our preclinical studies and clinical studies or may require that we conduct additional studies;

 

    regulatory authorities may disagree with our proposed design of future clinical trials;

 

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    regulatory authorities may not accept data generated at our clinical study sites;

 

    we may be unable to obtain and maintain regulatory approval of our product candidate in any jurisdiction;

 

    the prevalence and severity of any side effects of any product candidate could delay or prevent commercialization, limit the indications for any approved product candidate, require the establishment of a risk evaluation and mitigation strategy, or REMS, or cause an approved product candidate to be taken off the market;

 

    regulatory authorities may identify deficiencies in our manufacturing processes or facilities or those of our third-party manufacturers;

 

    regulatory authorities may change their approval policies or adopt new regulations;

 

    the third-party manufacturers we expect to depend on to supply or manufacture our product candidates may not produce adequate supply;

 

    we, or our third-party manufacturers, may not be able to source or produce cGMP materials for the production of our product candidates;

 

    we may not be able to manufacture our product candidates at a cost or in quantities necessary to make commercially successful products;

 

    we may not be able to obtain adequate supply of our product candidates for our clinical trials;

 

    we may experience delays in the commencement of, enrollment of patients in and timing of our clinical trials;

 

    we may not be able to demonstrate that our product candidates are safe and effective as a treatment for its indications to the satisfaction of regulatory authorities, and we may not be able to achieve and maintain compliance with all regulatory requirements applicable to our product candidates;

 

    we may not be able to maintain a continued acceptable safety profile of our products following approval;

 

    we may be unable to establish or maintain collaborations, licensing or other arrangements;

 

    the market may not accept our product candidates;

 

    we may be unable to establish and maintain an effective sales and marketing infrastructure, either through the creation of a commercial infrastructure or through strategic collaborations, and the effectiveness of our own or any future strategic collaborators’ marketing, sales and distribution strategy and operations will affect our profitability;

 

    we may experience competition from existing products or new products that may emerge;

 

    we and our licensors may be unable to successfully obtain, maintain, defend and enforce intellectual property rights important to protect our product candidates; and

 

    we may not be able to obtain and maintain coverage and adequate reimbursement from third-party payors.

If any of these risks materializes, we could experience significant delays or an inability to successfully commercialize IMP321, IMP701 and IMP731, or any other product candidate we may develop, which would have a material adverse effect on our business, financial condition and results of operations.

We may not make acquisitions in the future, or if we do, we may not be successful in integrating the acquired company, either of which could have a materially adverse effect on our business.

We completed our acquisition of Immutep, in December 2014 for consideration of up to US$28m in cash and stock. We have almost fully completed the integration of Immutep’s business into our own. We have not yet achieved, and may never achieve, the full benefit of the clinical development expectations, product portfolio enhancements or revenue generations we expected at the time of the acquisition. In addition, even if we achieve the expected benefits, we may be unable to achieve them within the anticipated time frame. Also, there may be unexpected problems in the business unrelated to the Immutep acquisition that have a negative effect on our business. If we fail to implement our business strategy, we may be unable to achieve expected results and our business, financial condition and results of operations may be materially and adversely affected.

 

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Specific risks associated with the remaining integration include the following:

 

    the potential loss of licensors, licensees, other business partners or independent contractors;

 

    failure to effectively continue the clinical trials;

 

    failure to effectively consolidate functional areas, which may be impeded by inconsistencies in, or conflicts between, standards, controls, procedures, policies, business cultures and compensation structures;

 

    potential future impairment charges, write-offs, write-downs or restructuring charges that could adversely affect our results of operations;

 

    significant deficiencies or material weaknesses in internal controls over financial reporting;

 

    exposure to unknown liabilities or other obligations of Immutep, which may include matters relating to employment, labor and employee benefits, litigation, accident claims and environmental issues, and which may affect our ability to comply with applicable laws;

 

    the coordination of resources across broad geographical areas; and

 

    the challenges of moving toward a single brand and market identity.

Immutep is our only significant acquisition in the recent history of Prima. Identifying strategic acquisitions is part of our business plan and may become an increasingly important part of our growth. There is, however, no assurance that we will be successful in identifying, negotiating, or consummating any future acquisitions. If we fail to make any future acquisitions, our growth rate could be materially and adversely affected. Any additional acquisitions we undertake could involve the dilutive issuance of equity securities, incurring indebtedness and/or incurring large one-time expenses. In addition, acquisitions involve numerous risks, including difficulties in assimilating the acquired company’s operations, the diversion of our management’s attention from other business concerns, risks of entering into markets in which we have had no or only limited direct experience, and the potential loss of customers, key employees and drivers of the acquired company, all of which could have a materially adverse effect on our business and operating results. If we make acquisitions in the future, we cannot guarantee that we will be able to successfully integrate the acquired companies or assets into our business, which would have a materially adverse effect on our business, financial condition, and results of operations.

Ongoing and future clinical trials of product candidates may not show sufficient safety or efficacy to obtain requisite regulatory approvals for commercial sale.

Phase I and Phase II clinical trials are not primarily designed to test the efficacy of a product candidate but rather to test safety and to understand the product candidate’s side effects at various doses and schedules. Furthermore, success in preclinical and early clinical trials does not ensure that later large-scale trials will be successful nor does it predict final results. Acceptable results in early trials may not be repeated in later trials. Further, Phase III clinical trials may not show sufficient safety or efficacy to obtain regulatory approval for marketing. In addition, clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could require that the clinical trial be redone or terminated. The length of time necessary to complete clinical trials and to submit an application for marketing approval by applicable regulatory authorities may also vary significantly based on the type, complexity and novelty of the product candidate involved, as well as other factors. If we suffer any significant delays, setbacks or negative results in, or termination of, our clinical trials, it may be unable to continue the development of our products or product candidates or generate revenue and our business may be severely harmed.

If we do not obtain the necessary regulatory approvals we will be unable to commercialize our products.

The clinical development, manufacturing, sales and marketing of our products are subject to extensive regulation by regulatory authorities in the United States, the United Kingdom, the European Union, Australia and elsewhere. Despite the substantial time and expense invested in preparation and submission of a Biologic License Application or equivalents in other jurisdictions, regulatory approval is never guaranteed. The number, size and design of preclinical studies and clinical trials that will be required will vary depending on the product, the disease or condition for which the product is intended to be used and the regulations and guidance documents applicable to any particular product. The FDA or other regulators can delay, limit or deny approval of a product for many reasons, including, but not limited to, the fact that regulators may not approve our or a third-party manufacturer’s processes or facilities or that new laws may be enacted or regulators may change their approval policies or adopt new regulations requiring new or different evidence of safety and efficacy for the intended use of a product.

IMP321 is undergoing clinical trials; however, successful results in the trials and in the subsequent application for marketing approval are not guaranteed. Without additional clinical trials any other product in the current portfolio cannot obtain a regulatory approval. If we are unable to obtain regulatory approvals, we will not be able to generate revenue from this product. Even if we receive regulatory approval for any product candidate, our profitability will depend on our ability to generate revenues from the sale of those product candidates or the licensing of our technology.

 

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Even if our product candidates receive regulatory approval, it may still face development and regulatory difficulties that may delay or impair future sales of product candidates.

Even if we or our licensing partners receive regulatory approval to sell IMP321 or any other product candidate, the relevant regulatory authorities may, nevertheless, impose significant restrictions on the indicated uses, manufacturing, labelling, packaging, adverse event reporting, storage, advertising, promotion and record keeping or impose ongoing requirements for post-approval studies. In addition, regulatory agencies subject a marketed product, its manufacturer and the manufacturer’s facilities to continual review and periodic inspections. Previously unknown problems with the product candidate, including adverse events of unanticipated severity or frequency, may result in restrictions on the marketing of the product, and could include withdrawal of the product from the market. In addition, new statutory requirements may be enacted or additional regulations may be enacted that could prevent or delay regulatory approval of our products.

We have limited manufacturing experience with our product candidates.

We have no manufacturing capabilities and are dependent on third parties for cost effective manufacture and manufacturing process development of the company’s product candidates. Problems with third party manufacturers or the manufacturing process, or the scaling up of manufacturing activities as such may delay clinical trials and commercialization of our product candidates. To minimize the chance of these kinds of disruption, we enter into advance purchase agreements for reagents wherever possible.

Biological product candidates like IMP731, IMP701 or IMP321 usually have more complicated manufacturing procedures than chemically produced therapies. The change of manufacturing partners, manufacturing process changes or changes of other nature could impact the product quality and affect the comparability of different product batches. A lack of comparability could significantly impact the development timelines and could even lead to a situation where regulatory bodies require additional or new pre-clinical or clinical development.

The clinical development of autologous dendritic cell cancer vaccines such as CVac is complex and more expensive to produce than most other biologicals such as IMP321. Biologicals like IMP321 offer greater commercial potential based on cost of goods alone. Such lower cost and greater commercial potential were main contributing factors in our decision to focus our clinical trial resources internally on developing IMP 321 whilst seeking a partner to develop CVac. With consolidation of the CVac program and the spin off transaction with Sydys Corporation, a US based special purpose vehicle, the manufacturing uncertainties surrounding CVac have now transferred to Sydys. Compared to our other partners Novartis and GlaxoSmithKline who are well funded and established within the industry, the transaction with Sydys bears significantly more risk given that Sydys first needs to establish itself and secure significant funds to develop CVac, and there is no guarantee that Sydys will be successful in that respect. The successful approval of CVac by regulatory authorities and the manufacturing of CVac will be beyond the control of Prima.

To the extent we rely significantly on contractors, we will be exposed to risks related to the business and operational conditions of our contractors.

We are a small company, with few internal staff and limited facilities. We are and will be required to rely on a variety of contractors to manufacture and transport our products, to perform clinical testing and to prepare regulatory dossiers. Adverse events that affect one or more of our contractors could adversely affect us, such as:

 

    a contractor is unable to retain key staff that have been working on our product candidates;

 

    a contractor is unable to sustain operations due to financial or other business issues;

 

    a contractor loses their permits or licenses that may be required to manufacture our products or product candidates; or

 

    errors, negligence or misconduct that occur within a contractor may adversely affect our business.

We depend on, and will continue to depend on, collaboration and strategic alliances with third partners. To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances.

An important element of our strategy for developing, manufacturing and commercializing our product candidates is entering into partnerships and strategic alliances with other pharmaceutical companies or other industry participants. For example, we currently have collaborative arrangements with Eddingpharm for the development of IMP321 for China and Taiwan. Any revenues from sales of CVac will be dependent on the success of the collaboration partner. In principle the same applies to IMP731 and IMP701 or any other partnered product candidate.

 

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Any partnerships or alliance we have or may have in the future may be terminated for reasons beyond our control or we may not be able to negotiate future alliances on acceptable terms, if at all. These arrangements may result in us receiving less revenue than if it sold its products directly, may place the development, sales and marketing of its products outside of its control, may require it to relinquish important rights or may otherwise be on unfavorable terms. Collaborative arrangements or strategic alliances will also subject us to a number of risks, including the risk that:

 

    we may not be able to control the amount and timing of resources that our strategic partner/collaborators may devote to the product candidates;

 

    strategic partner/collaborators may experience financial difficulties;

 

    the failure to successfully collaborate with third parties may delay, prevent or otherwise impair the development or commercialization of our product candidates or revenue expectations;

 

    products being developed by partners/collaborators may never reach commercial stage resulting in reduced or even no milestone or royalty payments;

 

    business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability to complete their obligations under any arrangement;

 

    a collaborator could independently move forward with a competing product developed either independently or in collaboration with others, including our competitors; and

 

    collaborative arrangements are often terminated or allowed to expire, which would delay the development and may increase the cost of developing product candidates.

Our research and development efforts will be jeopardized if we are unable to retain key personnel and cultivate key academic and scientific collaborations.

Our success depends largely on the continued services of our senior management and key scientific personnel and on the efforts and abilities of our senior management to execute our business plan. During the fiscal year ended June 30, 2016, we experienced a significant change in our senior management team with Dr. Sharron Gargosky, our former Chief Technical Officer and past CVac program manager, ceasing to be employed by us effective 30 November 2015. However, we consider the impact of her departure to be minimal with the divestment of CVac to Sydys Corporation. Our research and development activities of IMP321 will be overseen by Dr. Frédéric Triebel, the inventor of the technology.

Changes in our senior management may be disruptive to our business and may adversely affect our operations. For example, when we have changes in senior management positions, we may elect to adopt different business strategies or plans. Any new strategies or plans, if adopted, may not be successful and if any new strategies or plans do not produce the desired results, our business may suffer.

Moreover, competition among biotechnology and pharmaceutical companies for qualified employees is intense and as such we may not be able to attract and retain personnel critical to our success. Our success depends on our continued ability to attract, retain and motivate highly qualified management, clinical and scientific personnel, manufacturing personnel, sales and marketing personnel and on our ability to develop and maintain important relationships with clinicians, scientists and leading academic and health institutions. If we fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our product development and commercialization activities.

In addition, biotechnology and pharmaceutical industries are subject to rapid and significant technological change. Our product candidates may be or become uncompetitive. To remain competitive, we must employ and retain suitably qualified staff that are continuously educated to keep pace with changing technology, but may not be in a position to do so.

 

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Future potential sales of our products may suffer if they are not accepted in the marketplace by physicians, patients and the medical community.

There is a risk that IMP321 may not gain market acceptance among physicians, patients and the medical community, even if they are approved by the regulatory authorities. The degree of market acceptance of any of our approved products will depend on a variety of factors, including:

 

    timing of market introduction, number and clinical profile of competitive products;

 

    our ability to provide acceptable evidence of safety and efficacy and our ability to secure the support of key clinicians and physicians for our products;

 

    cost-effectiveness compared to existing and new treatments;

 

    availability of coverage, reimbursement and adequate payment from health maintenance organizations and other third-party payers;

 

    prevalence and severity of adverse side effects; and

 

    other advantages over other treatment methods.

Physicians, patients, payers or the medical community may be unwilling to accept, use or recommend our products which would adversely affect our potential revenues and future profitability.

If healthcare insurers and other organizations do not pay for our products or impose limits on reimbursement, our future business may suffer.

Our product candidate may be rejected by the market due to many factors, including cost. The continuing efforts of governments, insurance companies and other payers of healthcare costs to contain or reduce healthcare costs may affect our future revenues and profitability. In Australia and certain foreign markets the pricing of pharmaceutical products is already subject to government control. We expect initiatives for similar government control to continue in the United States and elsewhere. The adoption of any such legislative or regulatory proposals could harm our business and prospects.

Successful commercialization of our product candidate will depend in part on the extent to which reimbursement for the cost of our products and related treatment will be available from government health administration authorities, private health insurers and other organizations. Our product candidate may not be considered cost-effective and reimbursement may not be available to consumers or may not be sufficient to allow our products to be marketed on a competitive basis. Third-party payers are increasingly challenging the price of medical products and treatment. If third party coverage is not available for our products the market acceptance of these products will be reduced. Cost-control initiatives could decrease the price we might establish for products, which could result in product revenues lower than anticipated. If the price for our product candidate decreases or if governmental and other third-party payers do not provide adequate coverage and reimbursement levels our potential revenue and prospects for profitability will suffer.

We may be exposed to product liability claims which could harm our business.

The testing, marketing and sale of therapeutic products entails an inherent risk of product liability. We may face product liability exposure related to the testing of our product candidates in human clinical trials. If any of our products are approved for sale, we may face exposure to claims by an even greater number of persons than were involved in the clinical trials once marketing, distribution and sales of our products begin. Regardless of merit or eventual outcome, liability claims may result in:

 

    decreased demand for our products and product candidates;

 

    injury to our reputation;

 

    withdrawal of clinical trial participants;

 

    costs of related litigation;

 

    substantial monetary awards to patients and others;

 

    loss of revenues; and

 

    the inability to commercialize products and product candidates.

 

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We rely on a number of third party researchers and contractors to produce, collect, and analyze data regarding the safety and efficacy of our product candidates. We have quality control and quality assurance in place to mitigate these risks, as well as professional liability and clinical trial insurance to cover financial damages in the event that human testing is done incorrectly or the data is analyzed incorrectly. If a claim is made against us in conjunction with these research testing activities, the market price of our ordinary shares or ADSs may be negatively affected. We could also face additional liability beyond insurance limits if testing mistakes were to endanger any human subjects.

We are currently taking advantage of certain exemptions from having to comply with the Sarbanes-Oxley Act due to our status as an “emerging growth company”.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Accordingly, this allows us to postpone the date by which we must comply with some of the laws and regulations that are otherwise applicable to public companies and to reduce the amount of information we provide in our reports filed with the SEC, which could undermine investor confidence in our company and adversely affect the market price of our ordinary shares or ADSs.

For so long as we remain an “emerging growth company,” we may take advantage of certain exemptions from various requirements that are applicable to public companies that are not “emerging growth companies,” including, but not limited to, the provisions of Section 404(b) of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting. As a result, our independent registered public accounting firm will not be required to provide an attestation report on the effectiveness of our internal control over financial reporting for so long as we qualify as an “emerging growth company,” which may increase the risk that weaknesses or deficiencies in our internal control over financial reporting go undetected. Similarly, so long as we qualify as an “emerging growth company,” we may elect not to provide investors with certain information, including certain financial information and certain information regarding compensation of our executive officers, that we would otherwise have been required to provide in filings we make with the SEC, which may make it more difficult for investors and securities analysts to evaluate our company.

We may take advantage of these exemptions until we are no longer an “emerging growth company.” We would cease to be an “emerging growth company” upon the earliest of: (i) the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the U.S. Securities Act of 1933, as amended; (ii) the last day of the first fiscal year in which our annual gross revenues are $1 billion or more; (iii) the date on which we have, during the previous three-year period, issued more than $1 billion in non-convertible debt securities; or (iv) as of the end of any fiscal year in which the market value of our ordinary shares or ADSs held by non-affiliates exceeded $700 million as of the end of the second quarter of that fiscal year.

We cannot predict if investors will find our ordinary shares or ADSs less attractive because we may rely on these exemptions. If some investors find our ordinary shares or ADSs less attractive as a result, there may be a less active trading market for such shares, and our stock price may be more volatile and may decline.

Risks Related to Intellectual Property

Our success depends on our ability to protect our intellectual property and our proprietary technology.

Our success is to a certain degree also dependent on our ability to obtain and maintain patent protection or where applicable, to receive/maintain orphan drug designation/status and resulting marketing exclusivity for our product candidates.

We may be materially adversely affected by our failure or inability to protect our intellectual property rights. Without the granting of these rights, the ability to pursue damages for infringement would be limited. Similarly, any know-how that is proprietary or particular to our technologies may be subject to risk of disclosure by employees or consultants despite having confidentiality agreements in place.

Any future success will depend in part on whether we can obtain and maintain patents to protect our own products and technologies; obtain licenses to the patented technologies of third parties; and operate without infringing on the proprietary rights of third parties. Biotechnology patent matters can involve complex legal and scientific questions, and it is impossible to predict the outcome of biotechnology and pharmaceutical patent claims. Any of our future patent applications may not be approved, or we may not develop additional products or processes that are patentable. Some countries in which we may sell our product candidate or license our intellectual property may fail to protect our intellectual property rights to the same extent as the protection that may be afforded in the United States or Australia. Some legal principles remain unresolved and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in patents in the United States, the United Kingdom, the European Union, Australia or elsewhere. In addition, the specific content of patents and patent applications that are necessary to support and interpret patent claims is highly uncertain due to the complex nature of the relevant legal, scientific and factual issues. Changes in either patent laws or in interpretations of patent laws in the United States, the United Kingdom, the European Union or elsewhere may diminish the value of our intellectual property or narrow the scope of our patent protection. Even if we are able to obtain patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.

 

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Moreover, any of our pending applications may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or USPTO, the European Patent Office, or EPO, the Australian Patent and Trademark Office and/or any patents issuing thereon may become involved in opposition, derivation, reexamination, inter partes review, post grant review, interference proceedings or other patent office proceedings or litigation, in the United States or elsewhere, challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, and allow third parties to commercialize our technology or products and compete directly with us, without payment to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to exploit our intellectual property or develop or commercialize current or future product candidate.

The issuance of a patent is not conclusive as to the inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the U.S., the EU, Australia and elsewhere. Such challenges may result in loss of ownership or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit the duration of the patent protection of our technology and products. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

In addition, other companies may attempt to circumvent any regulatory data protection or market exclusivity that we obtain under applicable legislation, which may require us to allocate significant resources to preventing such circumvention. Such developments could enable other companies to circumvent our intellectual property rights and use our clinical trial data to obtain marketing authorizations in the EU, Australia and in other jurisdictions. Such developments may also require us to allocate significant resources to prevent other companies from circumventing or violating our intellectual property rights.

Our attempts to prevent third parties from circumventing our intellectual property and other rights may ultimately be unsuccessful. We may also fail to take the required actions or pay the necessary fees to maintain our patents.

Intellectual property rights of third parties could adversely affect our ability to commercialize our products, such that we could be required to litigate with or obtain licenses from third parties in order to develop or market our products. Such litigation or licenses could be costly or not available on commercially reasonable terms.

Our commercial success may somewhat depend upon our future ability and the ability of our potential collaborators to develop, manufacture, market and sell our product candidates without infringing valid intellectual property rights of third parties.

If a third-party intellectual property right exists that requires the pursuit of litigation or administrative proceedings to nullify or invalidate the third-party intellectual property right concerned, or enter into a license agreement with the intellectual property right holder, which may not be available on commercially reasonable terms, if at all.

Third-party intellectual property right holders, including our competitors, may bring infringement claims against us. We may not be able to successfully settle or otherwise resolve such infringement claims. If we are unable to successfully settle future claims or otherwise resolve such claims on terms acceptable to us, we may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from, or experience substantial delays in, marketing our product candidate.

If we fail to settle or otherwise resolve any such dispute, in addition to being forced to pay damages, we or our potential collaborators may be prohibited from commercializing any product candidates we may develop that are held to be infringing, for the duration of the patent term. We might, if possible, also be forced to redesign our formulations so that we no longer infringe such third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.

To mitigate this risk, we have a patent strategy and monopoly around many of the technical areas we operate in with little room for others to achieve freedom to operate. From time to time we engage the advice of patent counsel to conduct checks on the freedom to operate position of our business with respect to claims protecting our product development candidates and our clinical and manufacturing strategies.

 

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We may become involved in lawsuits to protect and defend our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe our patents or other intellectual property and we may inadvertently infringe the patent or intellectual property of others. To counter infringement or unauthorized use, we may be required to file claims, and any related litigation and/or prosecution of such claims can be expensive and time consuming. Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their intellectual property. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid in whole or in part, unenforceable, or construe the patent’s claims narrowly allowing the other party to commercialize competing products on the grounds that our patents do not cover such products.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating losses and reduce our resources available for development activities. We may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. The effects of patent litigation or other proceedings could therefore have a material adverse effect on our ability to compete in the marketplace.

Confidentiality and invention assignment agreements with our employees, advisors and consultants may not adequately prevent disclosure of trade secrets and protect other proprietary information.

We consider proprietary trade secrets and/or confidential know-how and unpatented know-how to be important to our business. We may rely on trade secrets and/or confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. However, trade secrets and/or confidential know-how can be difficult to maintain as confidential.

To protect this type of information against disclosure or appropriation by competitors, our policy is to require our employees, advisors and consultants to enter into confidentiality and invention assignment agreements with us. However, current or former employees, advisors and consultants may unintentionally or willfully disclose our confidential information to competitors, and confidentiality and invention assignment agreements may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Enforcing a claim that a third-party obtained illegally and is using trade secrets and/or confidential know-how is expensive, time consuming and unpredictable. The enforceability of confidentiality and invention assignment agreements may vary from jurisdiction to jurisdiction.

Failure to obtain or maintain trade secrets and/or confidential know-how trade protection could adversely affect our competitive position. Moreover, our competitors may independently develop substantially equivalent proprietary information and may even apply for patent protection in respect of the same. If successful in obtaining such patent protection, our competitors could limit our use of our trade secrets and/or confidential know-how.

Intellectual property rights do not address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business, or permit us to maintain our competitive advantage. The following examples are illustrative:

 

    Others may be able to make products that are similar to IMP321 but that are not covered by our intellectual property rights.

 

    Others may independently develop similar or alternative technologies or otherwise circumvent any of our technologies without infringing our intellectual property rights.

 

    We or any of our collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we own, license or will own or license.

 

    We or any of our collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that we or they own or have obtained a license, or will own or will have obtained a license.

 

    It is possible that any pending patent applications that we have filed, or will file, will not lead to issued patents.

 

    Issued patents that we own may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors.

 

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    Our competitors might conduct research and development activities in countries where we do not have patent rights, or in countries where research and development safe harbor laws exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets.

 

    Ownership of our patents or patent applications may be challenged by third parties.

 

    The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products or product candidate.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and exploiting patents in the biopharmaceutical industry involve both technological and legal complexity. Therefore, obtaining and exploiting biopharmaceutical patents is costly, time-consuming and inherently uncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Such examples include:

 

    Nautilus, Inc. v. Biosig Instruments, Inc. (2014), where the Court imposed a stricter requirement for clarity of claim language than previously applied by the Federal Circuit, thereby making it easier to invalidate patents for insufficiently apprising the public of the scope of the invention.

 

    Limelight Networks, Inc. v. Akamai Technologies, Inc. (2014), where the Court articulated a standard for inducement of infringement that makes it more difficult to establish liability for inducing infringement of a multi-step method claim that is performed by multiple parties.

 

    Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), where the Court held that isolated naturally-occurring DNA is patent ineligible subject matter.

 

    KSR v. Teleflex (2007), where the Court decided unanimously that the Federal Circuit Court had been wrong in taking a narrow view of when an invention is “obvious” and thus cannot be patented.

 

    EBay Inc. v. MercExchange, LLC (2006), where the Court heightened the standard for an injunction after a finding of patent infringement.

 

    Merck KGgA v. Integra Lifesciences (2004), where the Court adopted an expansive interpretation of the activities associated with regulatory approval exempt from patent infringement.

In addition, the America Invents Act, or AIA, has been recently enacted in the United States, resulting in significant changes to the U.S. patent system. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, the combination of the U.S. Supreme Court decisions and AIA has created uncertainty with respect to the value of patents, once obtained. A few highlights of changes to U.S. patent law under the AIA are:

 

    Under the AIA, a patent is awarded to the “first-inventor-to-file” rather than the first to invent.

 

    There is a new definition of prior art which removes geographic and language boundaries found in the pre-AIA law. At the same time, certain categories of “secret” prior art have been eliminated.

 

    The AIA introduced new procedures for challenging the validity of issued patents: post-grant review and inter partes review.

 

    Patent owners under the AIA may now request supplemental examination of a patent to consider, reconsider, or correct information believed to be relevant to the patent.

 

    The AIA allows third parties to submit any patent, published application, or publication relevant to examination of a pending patent application with a concise explanation for inclusion during prosecution of the patent application.

The “first-inventor-to-file” system and the new definitions of prior art apply to U.S. patent applications with claims having an effective filing date on or after March 16, 2013. Until at least 2034, patent practice will involve both pre-AIA and AIA laws.

 

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Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could weaken our ability to obtain new patents or to exploit our existing patents and patents that we might obtain in the future. Similarly, the complexity and uncertainty of European patent laws has also increased in recent years. In addition, the European patent system is relatively stringent in the type of amendments that are allowed during prosecution. Changes in patent law or patent jurisprudence could limit our ability to obtain new patents in the future that may be important for our business.

We may face difficulties with protecting our intellectual property in certain jurisdictions, which may diminish the value of our intellectual property rights in those jurisdictions.

The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws in the U.S. and the EU, and many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions. If we or our collaboration partners encounter difficulties in protecting, or are otherwise precluded from effectively protecting, the intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished and we may face additional competition from others in those jurisdictions.

Some countries in Europe and China have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we or any of our licensors is forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position or commercial advantage may be impaired and our business and results of operations may be adversely affected.

Risks Relating to Our Securities

Our stock price is volatile and could decline significantly.

The market price of our ordinary shares historically has been, and we expect will continue to be, subject to significant fluctuations over short periods of time. These fluctuations may be due to factors specific to us, to changes in analysts’ recommendations and earnings estimates, to arbitrage between our Australian listed shares and our ADSs, to changes in exchange rates, or to factors affecting the biopharmaceutical industry or the securities markets in general. Market fluctuations, as well as general political and economic conditions, such as a recession, interest rate or currency fluctuations, could adversely affect the market price of our securities.

For example, during the last two fiscal years, the market price for our ordinary shares on the Australian Securities Exchange has ranged from as low as A$0.02 to a high of A$0.19. We may experience a material decline in the market price of our shares, regardless of our operating performance. Therefore, a holder of our ordinary shares or ADSs may not be able to sell those ordinary shares or ADSs at or above the price paid by such holder for such shares or ADSs. Price declines in our ordinary shares or ADSs could result from a variety of factors, including many outside our control. These factors include:

 

    the results of pre-clinical testing and clinical trials by us and our competitors;

 

    unforeseen safety issues or adverse side effects resulting from the clinical trials or the commercial use of our product candidate;

 

    regulatory actions in respect of any of our products or the products of any of our competitors;

 

    announcements of the introduction of new products by us or our competitors;

 

    market conditions, including market conditions in the pharmaceutical and biotechnology sectors;

 

    increases in our costs or decreases in our revenues due to unfavorable movements in foreign currency exchange rates;

 

    developments or litigation concerning patents, licenses and other intellectual property rights;

 

    litigation or public concern about the safety of our potential products;

 

    changes in recommendations or earnings estimates by securities analysts;

 

    actual and anticipated fluctuations in our quarterly operating results;

 

    deviations in our operating results from the estimates of securities analysts;

 

    rumors relating to us or our competitors;

 

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    additions or departures of key personnel;

 

    changes in third-party reimbursement policies; and

 

    developments concerning current or future strategic alliances or acquisitions.

Our ordinary shares may be considered a “penny stock” under SEC regulations which could adversely affect the willingness of investors to hold our ADSs.

The SEC has adopted regulations which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. During the fiscal year ended June 30, 2016, our ordinary shares traded on the ASX from a low of A$0.04 to a high of A$0.09 per share. During the fiscal year ended June 30, 2015, our ordinary shares traded on the ASX from low of A$0.02 to a high of A$0.19 per share. Penny stock rules impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors.” The term “accredited investor” refers generally to institutions with assets in excess of $5,000,000 or individuals with a net worth in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly with their spouse in each of the prior two years.

The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the SEC, which provides (a) contains a description of the nature and level of risk in the market for penny stocks in both public offerings and secondary trading; (b) contains a description of the broker’s or dealer’s duties to the customer and of the rights and remedies available to the customer with respect to a violation of such duties or other requirements of the securities laws; (c) contains a brief, clear, narrative description of a dealer market, including bid and ask prices for penny stocks and the significance of the spread between the bid and ask price; (d) contains a toll-free telephone number for inquiries on disciplinary actions; (e) defines significant terms in the disclosure document or in the conduct of trading in penny stocks; and (f) contains such other information and is in such form, including language, type size and format, as the SEC shall require by rule or regulation.

The broker-dealer also must provide, prior to effecting any transaction in a penny stock, the customer with (a) bid and offer quotations for the penny stock; (b) the compensation of the broker-dealer and its salesperson in the transaction; (c) the number of shares to which such bid and ask prices apply, or other comparable information relating to the depth and liquidity of the market for such stock; and (d) a monthly account statement showing the market value of each penny stock held in the customer’s account.

In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from those rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written acknowledgment of the receipt of a risk disclosure statement, a written agreement as to transactions involving penny stocks, and a signed and dated copy of a written suitability statement.

These disclosure requirements may have the effect of reducing the trading activity for our common stock. Therefore, stockholders may have difficulty selling our securities.

In addition, the low trading price of our ordinary shares may adversely affect the willingness of investors to hold our ADSs.

We may be a passive foreign investment company (PFIC) which would subject our U.S. investors to adverse tax rules.

Holders of our ADSs who are U.S. residents face income tax risks. There is a substantial risk that we are currently a passive foreign investment company, or PFIC, which could result in a reduction in the after-tax return to a “U.S. Holder” of our ADRs and reduce the value of our ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset that produces passive income.

The determination of whether we are a PFIC is made on an annual basis and depends on the composition of our income and the value of our assets. Therefore, it is possible that we could be a PFIC in the current year as well as in future years. If we are classified as a PFIC in any year that a U.S. Holder owns ADSs, the U.S. Holder will generally continue to be treated as holding ADSs of a PFIC in all subsequent years, notwithstanding that we are not classified as a PFIC in a subsequent year. Dividends received by the U.S. Holder and gains realized from the sale of our ADSs would be taxed as ordinary income and subject to an interest charge. We urge U.S. investors to consult their own tax advisors about the application of the PFIC rules and certain elections that may help to minimize adverse U.S. federal income tax consequences in their particular circumstances.

 

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We have never paid a dividend and we do not intend to pay dividends in the foreseeable future which means that holders of shares and ADSs may not receive any return on their investment from dividends.

To date, we have not declared or paid any cash dividends on our ordinary shares and currently intend to retain any future earnings for funding growth. We do not anticipate paying any dividends in the foreseeable future. Dividends may only be paid out of our profits. Payment of cash dividends, if any, in the future will be at the discretion of our board of directors. Our holders of shares and ADSs may not receive any return on their investment from dividends. The success of your investment will likely depend entirely upon any future appreciation of the market price of our ordinary shares, which is uncertain and unpredictable. There is no guarantee that our ordinary shares will appreciate in value or even maintain the price at which you purchased your ordinary shares.

Currency fluctuations may adversely affect the price of the ADSs relative to the price of our ordinary shares.

The price of our ordinary shares is quoted in Australian dollars and the price of our ADSs will be quoted in U.S. dollars. Movements in the Australian dollar/U.S. dollar exchange rate may adversely affect the U.S. dollar price of our ADSs and the U.S. dollar equivalent of the price of our ordinary shares. In the last two years, the Australian dollar has as a general trend depreciated against the U.S. dollar. Any continuation of this trend may positively affect the U.S. dollar price of our ADSs and the U.S. dollar equivalent of the price of our ordinary shares, even if the price of our ordinary shares in Australian dollars increases or remains unchanged. However, this trend may not continue and may be reversed. If the Australian dollar weakens against the U.S. dollar, the U.S. dollar price of the ADSs could decline, even if the price of our ordinary shares in Australian dollars increases or remains unchanged.

The requirements of being a public company may strain our resources and divert management’s attention and if we are unable to maintain effective internal control over financial reporting in the future, the accuracy and timeliness of our financial reporting may be adversely affected.

As a publicly-traded company, we are subject to the reporting requirements of the U.S. Securities Exchange Act of 1934, as amended (the Exchange Act), the Sarbanes-Oxley Act, the Dodd-Frank Act, the listing requirements of the NASDAQ Global Market and other applicable securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs, make some activities more difficult, time-consuming or costly and increase demand on our systems and resources. The Exchange Act requires, among other things, that we file certain reports with respect to our business and results of operations. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. In order to maintain and, if required, improve our disclosure controls and procedures and internal control over financial reporting to meet this standard, significant resources and management oversight are required. As a result, management’s attention may be diverted from other business concerns, which could adversely affect our business and results of operations.

The Sarbanes-Oxley Act requires, among other things, that we assess the effectiveness of our internal control over financial reporting annually and disclosure controls and procedures quarterly. In particular, beginning with fiscal year ended on June 30, 2013, we have performed system and process evaluation and testing of our internal control over financial reporting to allow our management to report on the effectiveness of our internal control over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act. We have in prior fiscal years identified material weaknesses that have been remediated. If we identify material weaknesses in future periods or we are not able to comply with the requirements of Section 404 in a timely manner, our reported financial results could be restated, we could be subject to investigations or sanctions by regulatory authorities, which would require additional financial and management resources, and the market price of our stock could decline.

Our ordinary shares are listed and traded on the ASX and NASDAQ and on Over The Counter markets within Germany. Price levels for our ordinary shares could fluctuate significantly on either market, independent of our share price on the other market. Investors could seek to sell or buy our shares to take advantage of any price differences between the three markets through a practice referred to as arbitrage. Any arbitrage activity could create unexpected volatility in our share prices on either exchange and the volumes of shares available for trading on either exchange. In addition, holders of shares in either jurisdiction will not be immediately able to transfer such shares for trading on the other markets without effecting necessary procedures with our transfer agent. This could result in time delays and additional cost for our shareholders. Further, if we are unable to continue to meet the regulatory requirements for listing on the ASX and NASDAQ, we may lose our listing on any of these exchanges, which could impair the liquidity of our shares.

 

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Risks Relating to Our Location in Australia

Currency fluctuations may expose us to increased costs and revenue decreases.

Our business is affected by fluctuations in foreign exchange rates. Currency fluctuations could, therefore, cause our costs to increase and revenues to decline. Our expenses will be denominated in Australian dollars, U.S. dollars and European euro. Last year, the Australian dollar has, as a general trend, depreciated against the U.S. dollar and European euro, whereas two years ago, the Australian dollar had appreciated against the U.S. dollar and European Euro. We conduct clinical trials in many different countries and we have manufacturing of our product candidate undertaken outside of Australia, which exposes us to potential cost increases resulting from fluctuations in exchange rates. In fiscal 2016, we made foreign exchange losses as a result of currency fluctuations of A$0.6 million. In fiscal 2015, we made foreign exchange gains as a result of currency fluctuations of A$0.5 million. In fiscal 2014 our foreign exchange gain was A$0.4 million.

Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares.

We are incorporated in Australia and are subject to the takeovers laws of Australia. Amongst other things, we are subject to the Corporations Act 2001 (Commonwealth of Australia). Subject to a range of exceptions, the Corporations Act prohibits the acquisition of a direct or indirect interest in our issued voting shares (including through the acquisition of ADSs) if the acquisition of that interest will lead to a person’s or someone else’s voting power in us increasing from 20% or below to more than 20%, or increasing from a starting point that is above 20% and below 90%. Exceptions to the general prohibition include circumstances where the person makes a formal takeover bid for us, if the person obtains shareholder approval for the acquisition or if the person acquires less than 3% of the voting power of us in any rolling six month period. Australian takeovers laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares.

Rights as a holder of ordinary shares are governed by Australian law and our Constitution and differ from the rights of shareholders under U.S. law. Holders of our ordinary shares or ADSs may have difficulty in effecting service of process in the United States or enforcing judgments obtained in the United States.

We are a public company incorporated under the laws of Australia. Therefore, the rights of holders of our ordinary shares are governed by Australian law and our Constitution. These rights differ from the typical rights of shareholders in U.S. corporations. The rights of holders of ADSs are affected by Australian law and our Constitution but are governed by U.S. law. Circumstances that under U.S. law may entitle a shareholder in a U.S. company to claim damages may also give rise to a cause of action under Australian law entitling a shareholder in an Australian company to claim damages. However, this will not always be the case. Holders of our ordinary shares or ADSs may have difficulties enforcing, in actions brought in courts in jurisdictions located outside the U.S., liabilities under U.S. securities laws. In particular, if such a holder sought to bring proceedings in Australia based on U.S. securities laws, the Australian court might consider:

 

    that it did not have jurisdiction; and/or

 

    that it was not an appropriate forum for such proceedings; and/or

 

    that, applying Australian conflict of laws rule, U.S. law (including U.S. securities laws) did not apply to the relationship between holders of our ordinary shares or ADSs and us or our directors and officers; and/or

 

    that the U.S. securities laws were of a public or penal nature and should not be enforced by the Australian court.

Holders of our ordinary shares and ADSs may also have difficulties enforcing in courts outside the U.S. judgments obtained in the U.S. courts against any of our directors and executive officers or us, including actions under the civil liability provisions of the U.S. securities laws.

As a foreign private issuer whose shares are listed on the NASDAQ Global Market, we may follow certain home country corporate governance practices instead of certain NASDAQ requirements.

As a foreign private issuer whose shares are listed on the NASDAQ Global Market, we are permitted to follow certain home country corporate governance practices instead of certain requirements of The NASDAQ Marketplace Rules. As an Australian company listed on the NASDAQ Global Market, we may follow home country practice with regard to, among other things, the composition of the board of directors, director nomination process, compensation of officers and quorum at shareholders’ meetings. In addition, we may follow Australian law instead of the NASDAQ Marketplace Rules that require that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest in the company and certain acquisitions of the stock or assets of another company. As a foreign private issuer that has

 

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elected to follow a home country practice instead of NASDAQ requirements, we have submitted to NASDAQ a written statement from our independent counsel certifying that our practices are not prohibited by Australian laws. In addition, a foreign private issuer must disclose in Annual Reports filed with the U.S. Securities and Exchange Commission each such requirement that it does not follow and describe the home country practice followed by the issuer instead of any such requirement. Accordingly, our shareholders may not be afforded the same protection as provided under NASDAQ’s corporate governance rules. Please see “Item 6. Directors, Senior Management and Employees—C. Board Practices” for further information.

Risks Related to an Investment in Our ADSs

Our ADS holders are not shareholders and do not have shareholder rights.

The Bank of New York Mellon, as depositary, registers and delivers our American Depositary Shares, or ADSs. Our ADS holders will not be treated as shareholders and do not have the rights of shareholders. The depositary will be the holder of the shares underlying our ADSs. Holders of our ADSs will have ADS holder rights. A deposit agreement among us, the depositary and our ADS holders, and the beneficial owners of 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. For a description of ADS holder rights, see “Item 12. Description of Securities Other than Equity Securities—D. American Depositary Shares.” Our shareholders have shareholder rights. Australian law and our constitution govern shareholder rights. For a description of our shareholders’ rights, see “Item 10. Additional Information—B. Memorandum and Articles of Association.” Our ADS holders do not have the same voting rights as our shareholders. Shareholders are entitled to our notices of general meetings and to attend and vote at our general meetings of shareholders. At a general meeting, every shareholder present (in person or by proxy, attorney or representative) and entitled to vote has one vote on a show of hands. Every shareholder present (in person or by proxy, attorney or representative) and entitled to vote has one vote per fully paid ordinary share on a poll. This is subject to any other rights or restrictions which may be attached to any shares. ADS holders may exercise voting rights with respect to the underlying ordinary shares only in accordance with the provisions of the deposit agreement. Under the deposit agreement, ADS holders vote by giving voting instructions to the depositary. Upon receipt of instructions, the depositary will try to vote in accordance with those instructions. Otherwise, ADS holders will not be able to vote unless they withdraw the ordinary shares underlying their ADSs. ADS holders may not learn of ordinary shareholders’ meetings in time to instruct the depositary or withdraw underlying ordinary shares. If we ask for our ADS holders’ instructions, the depositary will notify our ADS holders of the upcoming vote and arrange to deliver our voting materials and form of notice to them. The depositary will try, as far as practical, subject to Australian law and the provisions of the depositary agreement, to vote the shares as our ADS holders instruct. The depositary will not vote or attempt to exercise the right to vote other than in accordance with the instructions of the ADS holders. We cannot assure our ADS holders that they will receive the voting materials in time to ensure that they can instruct the depositary to vote their shares. This means that there is a risk that our ADS holders may not be able to exercise voting rights and there may be nothing they can do if their shares are not voted as they requested.

Our ADS holders do not have the same rights to receive dividends or other distributions as our shareholders.

Subject to any special rights or restrictions attached to a share, the directors may determine that a dividend will be payable on a share and fix the amount, the time for payment and the method for payment (although we have never declared or paid any cash dividends on our ordinary stock and we do not anticipate paying any cash dividends in the foreseeable future). Dividends may be paid on shares of one class but not another and at different rates for different classes. Dividends and other distributions payable to our shareholders with respect to our ordinary shares generally will be payable directly to them. Any dividends or distributions payable with respect to ordinary shares will be paid to the depositary, which has agreed to pay to our ADS holders the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, after deducting its fees and expenses. Our ADS holders will receive these distributions in proportion to the number of shares their ADSs represent. In addition, there may be certain circumstances in which the depositary may not pay to our ADS holders amounts distributed by us as a dividend or distribution.

There are circumstances where it may be unlawful or impractical to make distributions to the holders of our ADSs.

The deposit agreement with the depositary generally requires the depositary to convert foreign currency it receives in respect of deposited securities into U.S. dollars and distribute the U.S. dollars to ADS holders, provided the depositary can do so on a reasonable basis. If it does not convert foreign currency, the depositary may distribute the foreign currency only to those ADS holders to whom it is possible to do so. If a distribution is payable by us in Australian dollars, the depositary 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. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, our ADS holders may lose some of the value of the distribution. The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. This means that our ADS holders 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.

 

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Nasdaq may delist our ADSs from trading on the exchange which could limit investors’ ability to make transactions in our ADSs and subject us to additional trading restrictions.

We may in the future fail to comply with the Nasdaq Global Market regulations and listing requirements as to minimum stockholders’ equity, minimum market value, minimum total assets and revenue, minimum bid price, minimum public float and other requirements (the “ Nasdaq Listing Requirements ”), and as a result Nasdaq may initiate procedures to delist our ordinary shares from the Nasdaq Global Market.

In the past fiscal year, our ADSs have been trading in a range from $0.72 to $1.80 per share, and the longest period below $1.00 was for 38 business days from January 14, 2016 through March 9, 2016, inclusive. Under Nasdaq’s Marketplace Rule 5450(a)(1) (the “ Rule ”), any company whose shares have a closing bid price less than $1.00 for 30 consecutive business days may be subject to a delisting proceeding by Nasdaq for failure to meet the Minimum Bid Price Rule. On March 4, 2016, we announced that we received a deficiency letter from NASDAQ that we were not in compliance with NASDAQ Listing Rule 5450(a)(1) for failing to have a bid price for our ADS of at least US$1.00 per share for the prior thirty trading days. On June 7, 2016, we announced that we received a letter from NASDAQ advising that as the bid price for our ADS had risen above US$1.00 for the required period of time, we had regained compliance with NASDAQ Listing Rule 5450(a)(1) and the matter was closed.

However, on August 10, 2016 we announced that we received another deficiency letter from NASDAQ advising that we were again not in compliance with Minimum Bid Price Rule. We have a period of 180-calendar days, or until February 6, 2017, to regain compliance with the Minimum Bid Price Rule. Within any time during the 180-day period the minimum closing bid price per share of the ADSs closes at or above US$1.00 for a minimum of ten consecutive business days, NASDAQ will provide written notification to the Company that it complies with the Minimum Bid Price Rule and the matter will be closed. Prima’s management is looking into various options available to the Company in order to regain compliance and maintain its continued listing on The NASDAQ Global Market.

If we fail to meet the continued listing criteria under the Rule or any of the Nasdaq Listing Requirements, our ordinary shares may be delisted from trading on the Nasdaq Global Market.

Delisting from the Nasdaq Global Market could have an adverse effect on our business and on the trading of our ADSs. If a delisting of our ADSs were to occur, such shares may trade in the over-the-counter market such as on the OTC Bulletin Board or on the “pink sheets”. The over-the-counter market is generally considered to be a less efficient market, and this could diminish investors’ interest in our ADSs as well as significantly impact the price and liquidity of our ADSs. Any such delisting may also severely complicate trading of our ADSs by our shareholders, or prevent them from re-selling their ADSs at/or above the price they paid. Furthermore, our relatively low trading volume on the Nasdaq Global Market may make it difficult for shareholders to trade ADSs or initiate any other transactions. Delisting may also make it more difficult for us to issue additional securities or secure additional financing.

 

ITEM 4. INFORMATION ON THE COMPANY

A. History and Development of the Company

Our legal and commercial name is Prima BioMed Ltd. We were incorporated under the laws of the Commonwealth of Australia on May 21, 1987.

Our registered office is located at Level 12, 95 Pitt Street, Sydney 2000 New South Wales, Australia and our telephone number is +61 (0)2 8315 7003. Our address on the Internet is www.primabiomed.com.au . The information on, or accessible through, our website is not part of this Annual Report on Form 20-F. We have included our website address in this Annual Report on Form 20-F solely as an inactive textual reference.

Fiscal 2015

On 8 July 2014 Prima BioMed was granted US Patent 8,771,701 from the US patent office, covering the company’s CVac cancer immunotherapy. This patent was given a term extension of almost 4 years providing for patent protection in the US for this patent until at least August 2022.

 

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On 9 July 2014, it was announced that Mr. Marc Voigt would replace Mr. Matthew Lehman as the CEO of Prima BioMed. Mr. Voigt has been with Prima BioMed since 2012 as the Chief Financial Officer and Chief Business Officer and an employee of the company’s German subsidiary since 2011, where he serves as a Managing Director. The shift in focus of the operations of the company to Germany due to the SAB grant support made it more practicable for Mr. Voigt to take over as CEO. In addition, Mr Voigt has over the past three years as the head of our European Operations, forged strong relationships within the European medical industry. During his role as CBO and CFO he has gained an excellent knowledge of both the operational and financial aspects of the business and he has a strong investment and transactional background within the biotechnology sector. Based in Germany, he is ideally placed to assume the responsibilities as CEO.

On 2 October 2014 Prima announced the acquisition of Immutep SA, a French biotechnology company based in Paris, for US$28m in cash and stock. Immutep brings a number of programs to Prima based on the LAG-3 immune control mechanism. Prima announced that the deal would be funded via an investment agreement with Bergen Global Opportunity Fund LP. The acquisition of Immutep was completed on 17 December 2014.

On 2 October 2014 Prima announced the securing of a US$37.4m investment agreement with Bergen Global Opportunity Fund LP. Under the agreement, Bergen made an initial upfront investment of US$2.5m by way of a 36-month interest-free unsecured convertible security and had the ability to invest up to US$700k per month in Prima’s equity over the following 24 months after their initial investment, with the option to increase each of the monthly tranches to an amount not exceeding US$1.5m by mutual consent of Bergen and the Company.

On 6 November 2014 Prima reported that the median for Overall Survival (OS) in the second remission patients in the CVac CAN-003 study had not been reached after 36 months, which compared favorably with a median OS for standard-of-care patients of 25.5 months. This analysis, for which the p value was 0.07, provided further evidence that CVac represented a good solution for second-line patients.

On 15 December 2014 Prima announced that it had received regulatory approvals to commence a single-arm pilot trial of CVac in post-resection pancreatic cancer that would recruit up to 40 patients.

On 29 December 2014 Prima received a ‘Notice of Bid Price Deficiency’ from Nasdaq, advising the company that the company had until 22 June 2015 to increase the Bid Price to over US$1.00 per ADR for a minimum of ten consecutive business days, or the ADRs would be removed from trading on the Nasdaq Global Market. Nasdaq advised on 3 June 2015 that compliance with the Minimum Bid Price Rule had been regained.

On 20 January 2015 Prima announced that it had received A$777,000 in a cash rebate from the Australian Federal Government’s R&D tax incentive program.

On 27 January 2015 Prima announced that it has received a milestone payment from GlaxoSmithKline (GSK) related to the first dosing in a clinical trial of GSK2831781, a monoclonal antibody for autoimmune disease.

On 27 February 2015 Prima advised that it had ceased recruitment into their outstanding CVac studies and was prioritizing development of the IMP321 compound that it had acquired with Immutep.

On 11 May 2015 Prima announced a collaboration with NEC Corporation and Yamaguchi University in Japan in which IMP321 would be used to adjuvant a peptide vaccine that had been developed by Yamaguchi University for the treatment of hepatocellular carcinoma.

On 15 May 2015 Prima announced that Ridgeback Capital Investments LP, or Ridgeback, a US-based specialist healthcare investor, would be investing A$15m in Prima BioMed via a share placement at 1.73 cents (to raise A$1.25m) to be followed, after shareholder approval, by a Convertible Note with a fixed conversion price of 2 cents (to raise A$13.75m). The Convertible Note was subject to shareholder approval, which was obtained on 31 July 2015. The Convertible Note has a ten-year term, accrues interest at 3% per annum (which is payable at maturity) and is convertible at Ridgeback’s election. As part of this investment, Ridgeback also received two warrants: (i) a warrant to purchase 8,475,995 ordinary shares at 2.5 cents per share, exercisable at any time, which expires on 4 August 2025 and (ii) a warrant to purchase 371,445,231 ordinary shares at 2.37 cents per share, exercisable at any time, which expires on 4 August 2020. The share price of each warrant is subject to standard adjustments in accordance with the ASX Listing Rules. On 27 May 2015, Ridgeback’s investment was increased by another 28,000,000 shares as a result of the conversion of the convertible note held by Bergen Global Opportunity Fund, LP, which precipitated a change in the terms of Ridgeback’s subscription agreement with Prima.

 

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On 19 May 2015 Prima announced final Overall Survival numbers from CVac’s CAN-003 study. In this analysis the median survival number for CVac second remission patients had still not been reached at 42 months, and the p value remained 0.07 when compared to 25.5 months for Standard-of-Care.

On 25 May 2015 Prima announced that it was collaborating with Database Integrations Inc on commercializing the iCAN software platform that powers CVac.

On 29 May 2015 Prima announced that it had filed for patent protection over the use of IMP321 with checkpoint inhibitors.

On 11 June 2015 Prima announced that it received a €226,055 rebate from the French government under France’s Crédit d’Impôt Recherche (research tax credit) scheme.

Fiscal 2016

On 29 June 2015 Prima BioMed announced a Notice of Meeting for the Extraordinary General Meeting to be held in Sydney on 31 July 2015. The EGM resolutions were in regards to the acquisition of Immutep SA, and, US-based Ridgeback Capital Investments.

On 7 July 2015 Prima BioMed received positive scientific advice from the European Medicines Agency regarding the clinical trial design for the development program of IMP321 in metastatic breast cancer.

On 7 July 2015 Prima BioMed announced a Share Purchase Plan to allow eligible shareholders to subscribe for up to A$15,000 worth of new shares, at an issue price of 5 cents per share to raise up to A$5m. On 24 July 2015 Prima announced a successful capital raising of A$10M via the SPP.

On 31 July 2015 Prima BioMed announced the results of the 2015 Extraordinary General Meeting. All 5 Resolutions were passed.

On 4 August 2015 Prima BioMed announced the formal termination of its US$37.4m investment agreement with Bergen Global Opportunity Fund, LP. The New York institutional investor managed by Bergen Asset Management was terminated by mutual consent. The facility was established in October 2014 in order to assist with the funding of the acquisition of Immutep SA (completed December 2014), as well as assisting Prima through to its capital raising in May – July 2015. Upon the conclusion of the investment agreement, Bergen exercised their options, and convertible note.

On 14 August 2015 Prima BioMed announced the commencement of a milestone payment program for IMP701 from its collaboration and licensing agreement with Novartis relating to its Phase I IMP701 LAG-3 antibody.

On 9 October 2015 Prima BioMed received a €306,000 (A$475,000) in grant funding from the European Union and the German Free State of Saxony. The grant, administered by the Saxony Development Bank, was in relation to the past development work on the CVac™ therapy.

On 13 October 2015 Prima BioMed raised A$1.55M via a placement of shares at A$0.05 per share to Nyenburgh Investment Partners (NYIP). The proceeds were used to fund Prima’s IMP321 clinical trial program.

On 27 October 2015 Prima BioMed received approval from Belgium’s Federal Agency for Medicines and Health Products for the commencement of the AIPAC study (Phase IIb clinical study of IMP321).

On 30 October 2015 Prima BioMed announced it raised A$2.0M via an equity placement at $0.05 per ordinary share to a leading Australian institutional investor. The proceeds were used to fund Prima’s IMP321 clinical trial program.

On 18 November 2015 Prima BioMed unveiled a new study of IMP321 in Australia. The Phase I Combination Study of IMP321 + Checkpoint Inhibitor, called ‘TACTI-mel’ (‘Two ACTive Immunotherapeutics in melanoma’), is a potentially revolutionary study in immuno-oncology by combining APC activator with an approved checkpoint inhibitor in patients with metastatic melanoma. The Human Research Ethics Committee at the Greenslopes Private Hospital in Queensland cleared the study protocol, with the first patient expected to enter study in the first-half of 2016.

 

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On 26 November 2015 Prima BioMed received a $420K cash rebate from the Australian federal government’s R&D tax incentive program.

On 11 December 2015, in connection with a previously announced collaboration with NEC Corporation and Yamaguchi University in which Prima’s IMP321 would be used to adjuvant a peptide vaccine that had been developed by Yamaguchi University for the treatment of hepatocellular carcinoma, Prima BioMed announced that favourable safety data from studies conducted by NEC Corporation and Yamaguchi University has resulted in a decision to progress the vaccine into clinical research progress with a New Material Transfer Agreement. Under such new Material Transfer Agreement, Yamaguchi University will work towards clinical research in cancer patients, which will be initiated in Japan in the first quarter of 2016.

On 2 December 2015 Prima BioMed initiated a Phase IIb study in metastatic breast cancer (AIPAC). The first clinical site was initiated in Belgium, with the Institutional Review Board approval obtained at four clinical sites in Belgium and three sites in the Netherlands. The University Hospital Saint-Luc in Brussels was the first AIPAC trial site.

On 27 January 2016 Prima BioMed announced the initiation of the first clinical trial site for TACTI-mel, a Phase I clinical study in melanoma using its lead compound IMP321, to be conducted in Australia. The study will evaluate safety as the primary endpoint and anti-tumour activity and the immune response to the combination as secondary endpoints.

On 28 January 2016 Prima BioMed announced the granting of a patent relating to Prima’s IMP731 antibody (originally developed by Immutep): Patent number US 9,244,059 entitled “Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease” by the United States Patent and Trademark Office.

On 2 March 2015 Prima BioMed and WuXi Biologics announced that through their strategic supply partnership, Prima’s first-in-class immuno-oncology product candidate IMP321 (LAG-3 Ig fusion protein),manufactured at WuXi’s state-of-the-art cGMP facility in China, has been dosed in a Phase IIb clinical trial in Belgium. The IMP321 clinical samples were the first biological manufactured in China to receive regulatory approval for administration in clinical trials in Europe.

On 4 March 2016 Prima BioMed received a NASDAQ Notice of Bid Price Deficiency for the period from January 13, 2016 through February 26, 2016. Prima was given till 29 August 2016 to increase the bid price to over US$1.00 per ADR for a minimum of ten consecutive business days, or the ADRs would be removed from trading on the Nasdaq Global Market. Nasdaq advised on 7 June 2016 that compliance with the Minimum Bid Price Rule had been regained.

On 15 March 2016 Prima BioMed published IMP321 Safety and Immune Monitoring Data in the March 15 edition of the Clinical Cancer Research journal. The investigator-led clinical trial in melanoma using IMP321 as an adjuvant to a therapeutic vaccine was the result of a long-standing academic collaboration between Dr. Frédéric Triebel, Prima’s Chief Scientific Officer and Chief Medical Officer and scientists at the Ludwig Centre for Cancer Research at the University of Lausanne, Switzerland.

On 2 May 2016 Prima BioMed announced the granting of patent number 5908210 entitled “Use of Recombinant LAG-3 or the Derivatives thereof for Eliciting Monocyte Immune Response” by the Japanese Patent Office. This patent supports the use of IMP321 as it is being used in the AIPAC trial in metastatic breast cancer.

On 12 May 2016 Prima BioMed entered into a sale and exclusive licensing agreement with Sydys Corporation to advance CVac’s immuno-oncology program and oversee its future development. The transaction was considered the best entrepreneurial solution to position CVac for clinical success and to continue the program’s development without further resource commitment from Prima. The transaction also provides the potential for considerable future milestone and royalty payments over time.

On 22 June 2016 Prima BioMed announced initial safety data from the first cohort of patients in its Phase IIb AIPAC chemo-immunotherapy clinical study of Prima’s lead compound, IMP321. The first six patients received 6 mg doses of IMP321 in combination with paclitaxel, which proved to be safe and well tolerated with no drug related serious adverse events. The data also demonstrated activation of blood monocytes/dendritic cells and CD8 T cells.

 

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B. Business Overview

Background

Prima BioMed is striving to become a leader in the development of immunotherapeutic products for cancer. Our key product is IMP321, which is a recombinant protein in clinical trials for the treatment of cancer. Our former lead product candidate in development was CVac™, an autologous dendritic cell based product in clinical trials for late stage epithelial ovarian cancer patients in complete remission. Prima has out-licensed the development and commercialisation of CVac to Sydys Corporation. See “Item 4. Information on the Company—B. Business Overview—CVac Clinical Development for the Treatment of Ovarian Cancer Patients in Remission” below for more information.

Operations Summary

Prima BioMed has administrative offices in Sydney, Australia and in Germany. With the acquisition of Immutep in December 2014 we also have a small office and laboratory located in Paris for the conduct of research and development relating to the LAG-3 program, under which we have three product candidates: IMP321, IMP701 and IMP731.

As of June 30, 2016, we employed 22 people. Our internal staff manages finances, business development, intellectual property, investor relations, manufacturing, and clinical development. We make extensive use of outside contractors and consultants to help manage manufacturing and clinical trials.

IMP321 Clinical Development

Prima BioMed’s lead program is the development of IMP321, a recombinant protein that may be used in conjunction with chemotherapy to amplify a patient’s immune response. The product candidate was acquired through Prima Biomed’s acquisition of Immutep in December 2014. IMP321 may also be administered in combination with other agents and at different doses to achieve different effects on the immune system. These alternative applications of IMP321 are the subject of various clinical programs.

Background IP supporting the development of LAG-3 products has been licensed from Merck Serono in 2002. Development milestones and royalties are payable on earnings of LAG-3 products. Further details are provided under intellectual property section.

Prima BioMed is developing IMP321 jointly with Eddingpharm under a licensing agreement dated May 2013 between Immutep and Eddingpharm. Eddingpharm has the exclusive development right of the IMP321 product in China, Macau and Taiwan, while the development right in other countries is retained by Immutep. Eddingpharm has paid for the manufacture of IMP321 GMP grade material needed for the conduct of current clinical trials of IMP321. Future costs of manufacturing of IMP321 will be Prima’s responsibility. Immutep will offer technical assistance to Eddingpharm to facilitate its application to register IMP321 in China, Macau and Taiwan. Eddingpharm is also required to make further milestone payments to Immutep if IMP321 achieves specific development milestones as well as undisclosed royalties on sales. Eddingpharm’s co-development of IMP321 is supported by a sublicense from Immutep to the background Serono licensed IP.

In Fiscal 2016, Prima Biomed started two new clinical trials for IMP321. The first one was Active Immunotherapy PAClitaxel (AIPAC), a Phase IIb study on IMP321’s effectiveness in treating metastatic breast cancer. Meetings have taken place with the European Medicines Agency (EMA) in regard to protocol design of the AIPAC study and the EMA have shown their support of the design, although a scientific advice is not legally binding. The primary purpose of the AIPAC trial, which will have a study group of up to 211 patients, is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival as the primary clinical endpoint in this patient population. The second of the two clinical trials was Two ACTive Immunotherapeutics in melanoma (TACTI-mel), a Phase I study on IMP321’s effectiveness in enhancing immune responses to PD-1 inhibitors in melanoma patients. The primary purpose of the TACTI-mel trial, which will have a study group of up to 24 patients, is to determine safety and dosage levels for combining the two products in future trials.

IMP731 Clinical Development

A second key product candidate of Prima Biomed is IMP731, a depleting antibody that removes T cells involved in autoimmunity. The product candidate was acquired through Prima Biomed’s acquisition of Immutep in December 2014. Immutep obtained the exclusive intellectual property rights of IMP731 from the Institut national de la santé et de la recherche médicale (INSERM Transfert) under a commercial co-ownership and exploitation agreement dated July 2010. In return, Immutep has the obligation to make customary milestone payments when the product achieves market authorization, plus additional minor royalty payments on sales.

The development of IMP731 has been licensed to Glaxo Smith Kline (GSK) under a license and research collaboration agreement dated December 2010 between Immutep and GSK. Under the sublicense, GSK has the exclusive development right of IMP731and will fund all the development costs and make milestone and royalty payments in the aggregate amount of up to £64 million to Immutep.

 

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Like Eddingpharm’s development of IMP321, GSK’s development of IMP731 is supported by a sublicense from Immutep that gives GSK the right to develop the product using background licensed IP from Serono.

In January 2015, Prima collected a milestone payment by GSK for the development of GSK2831781 for a first time in human clinical trial. More information about this clinical trial can be found at www.clinicaltrials.gov by searching for NCT02195349.

IMP701 Clinical Development

The third key product candidate of Prima Biomed is IMP701, an antagonist (blocking) antibody targeting the LAG-3 molecule with potential application in the treatment of cancer. It is designed to block the negative signal that cancerous cells may give to cytotoxic T cells, which may stop T cells from responding to the cancer. The product candidate was acquired through Prima Biomed’s acquisition of Immutep in December 2014.

The development of IMP701 has been licensed to CoStim Pharmaceuticals under an exclusive license and collaboration agreement dated September 2012 between Immutep and CoStim. Under the license, CoStim has the exclusive development right of IMP701, in consideration for the obligation to fund all the development costs and to make milestone and royalty payments to Immutep.

In February 2014, CoStim became a wholly owned subsidiary of Novartis, but the obligations of the Agreement remained with CoStim. Novartis has been conducting pre-clinical development of IMP701, and a Phase I clinical trial started in August 2015. The number of patients in that clinical trial was increased during Fiscal 2016. More information about this clinical trial can be found at www.clinicaltrials.gov by searching for NCT02460224.

Like Eddingpharm’s development of IMP321 and GSK’s development of IMP731, CoStim’s development of IMP701 is supported by a sublicense from Immutep that gives Co-Stim the right to develop the product using licensed technology from Serono.

Research Reagents used in the Development of LAG-3 Products

Immutep manufactures, sells and distributes research reagents used by scientists in the research of LAG-3 products. The business generates around €100,000 per year for Immutep. Some of these reagents are manufactured by Immutep and distributed through third party distributers, while one company holds manufacturing and distribution rights. These third parties include R&D Systems, Innoxis and Enzo.

The research reagents are manufactured based on background licensed technology from Serono. Immutep therefore has the obligation to make royalty payments on these sales to Serono under the licensing agreement dated December 2002 between Immutep and Serono.

CVac (Clinical Development for the Treatment of Ovarian Cancer Patients in Remission)

Prior to the acquisition of Immutep, Prima BioMed’s lead program was CVac the treatment of epithelial ovarian cancer patients who were in complete second remission. This disease represents a significant unmet medical need due to the high relapse rates and high morbidity associated with the disease.

After completing a strategic review of the assets after acquiring Immutep last year, Prima BioMed decided to consolidate the CVac clinical trial program and seek a development partner. In May 2016 Prima entered into a sale and exclusive licensing agreement with Sydys Corporation,Inc., a New York-based company that has been repurposed as a clinical stage biotechnology company in order to develop the CVac assets. The shares of Sydys are publicly traded in the United States.

Under the terms of the agreement, Sydys licensed Prima’s CVac related assets, including manufacturing protocols, clinical data from Phase I and Phase II trials, patents and know-how. Prima will also sell certain assets including some equipment and inventory to Sydys. In return, Prima received a 9.9% equity stake in Sydys at the time of closing as consideration for the assets being transferred. Given the significant capital requirements for conducting clinical trials, no upfront payment was received. However, should CVac be successfully commercialized, Prima could receive over A$400 million (US$293 million) in development, regulatory and commercial milestone payments payable for achievement of set commercial sales targets, in addition to low single digit royalties on sales. As Sydys possessed no significant cash reserves at the time of the transaction and is currently a one product company, there are significant risks associated with this transaction, such as the inability of Sydys to raise sufficient funds in order to develop and commercialize CVac.

In February 2014, Neopharm and Prima entered into an exclusive supply and manufacturing agreement whereby Prima granted Neopharm the exclusive right to distribute the CVac product in Israel and Palestine for treatment of cancer. Prima will provide support and data for Neopharm to obtain marketing authorisation of CVac in these territories. Upon approval, Prima will then manufacture CVac for Neopharm for treatment of patients. Prima and Neopharm will share net profits 50/50. This agreement will be transferred to Sydys as part of the completion of the exclusive licensing agreements.

 

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Intellectual Property

Throughout fiscal years 2015 and 2016, Prima owned, licensed or shared a total of 15 patent families. Five patent families are licensed from Merck Serono and cover the background LAG-3 intellectual property (refer to the following paragraph for further details). One of these Serono families expired throughout the year. Four families are jointly owned with collaborators and one of these is licensed to GSK. The remaining families are fully owned by Immutep. The portfolio provides strong protection for the use of IMP321 and the licensed assets.

On the 9 December 2002, Ares Trading SA (a fully owned subsidiary of Serono, now Merck Serono) and Immutep SA entered into an exclusive Licence Agreement for the development of the LAG-3 technology. The license covers use of background patents and know-how necessary for the development of certain LAG-3 products. Confidential milestones and royalties are payable to Serono while the patent or know-how license is in force. As the license is exclusive it provides a greater level of protection to the development of LAG-3 products. The license is sub-licensable and has been sublicensed in Agreements with GSK, Co-Stim and Eddingpharm. Improvements to the technology and new developments in intellectual property covered by the license are the property of Immutep.

CVac is protected in the major markets and a number of other countries by one patent family licensed from the Burnet Institute in Melbourne, Australia pursuant to a novation agreement between the Burnet Institute, Prima BioMed and Cancer Vac Pty Ltd. The patents provide claims for producing dendritic cells treated with mannan fusion protein (M-FP) and reinjecting the treated cells back into patients. This patent family has been sub-licensed to Sydys. See “Item 4. Information on the Company—B. Business Overview—CVac Clinical Development for the Treatment of Ovarian Cancer Patients in Remission” above for more information.

In addition to patent protection for all of our assets, we rely on unpatented trade secrets, know-how and other confidential information as well as proprietary technological innovation and expertize that are protected in part by confidentiality and invention assignment agreements with our employees, advisors and consultants.

Patent matters in biotechnology are highly uncertain and involve complex legal and factual questions. The availability and breadth of claims allowed in biotechnology and pharmaceutical patents cannot be predicted. Statutory differences in patentable subject matter may limit the protection Prima BioMed can obtain on some or all of their licensed inventions or prevent us from obtaining patent protection either of which could harm our business, financial condition and results of operations. Since patent applications are not published until at least 18 months from their first filing date and the publication of discoveries in the scientific literature often lags behind actual discoveries, we cannot be certain that we, or any of our licensors, were the first creator of inventions covered by pending patent applications, or that we or our licensors, were the first to file patent applications for such inventions. Additionally, the grant and enforceability of a patent is dependent on a number of factors that may vary between jurisdictions. These factors may include the novelty of the invention, the requirement that the invention not be obvious in the light of prior art (including prior use or publication of the invention), the utility of the invention and the extent to which the patent clearly describes the best method of working the invention. In short, this means that claims granted in various territories may vary and thereby influence commercial outcomes.

While we have applied and will continue to file for protection as appropriate for our therapeutic products and technologies, we cannot be certain that any future patent applications filed by the company, or licensed to us, will be approved, or that Prima BioMed will develop additional proprietary products or processes that are patentable or that we will be able to license any other patentable products or processes. Prima BioMed cannot be certain that others will not independently develop similar products or processes, duplicate any of the products or processes developed or being developed by the company or licensed to us, or design around the patents owned or licensed by us, or that any patents owned or licensed by us will provide us with competitive advantages.

Furthermore, we cannot be certain that patents held by third parties will not prevent the commercialization of products incorporating the technology developed by us or licensed to us, or that third parties will not challenge or seek to narrow, invalidate or circumvent any of the issued, pending or future patents owned or licensed by us.

Our commercial success will also depend, in part, on our ability to avoid infringement of patents issued to others. If a court determines that we were infringing any third party patents, we could be required to pay damages, alter our products or processes, obtain licenses or cease certain activities. We cannot be certain that the licenses required under patents held by third parties would be made available on terms acceptable to us or at all. To the extent that we are unable to obtain such licenses, we could be foreclosed from the development, export, manufacture or commercialization of the product requiring such license or encounter delays in product introductions while we attempt to design around such patents, and any of these circumstances could have a material adverse effect on our business, financial condition and results of operations. We may have to resort to litigation to enforce any patents issued or licensed to us or to determine the scope and validity of third party proprietary rights. Such litigation could result in substantial costs and diversion of effort by us. We may have to participate in opposition proceedings before the Australian Patent and Trademark Office or another foreign patent office, or in interference proceedings declared by the United States Patent and Trademark Office, to determine the priority of invention for patent applications filed by competitors. Any such litigation interference or opposition proceeding, regardless of outcome, could be expensive and time consuming, and adverse determinations in any such proceedings could prevent us from developing, manufacturing or commercializing our products and could have a material adverse effect on our business, financial condition and results of operations.

 

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During the course of fiscal years 2015 and 2016, the Company took action to file a trademark application for Prima BioMed in Australia. International applications were filed in the United States, Europe, China and Japan, claiming priority from Australia. None of these applications have yet been granted. CVac is a registered trademark in Australia, the United States, Europe, New Zealand, China, and the UAE. Immutep is a registered trademark in France. The Company owns both of these trademarks in these jurisdictions. The CVac trademark has been licensed to Sydys. See “Item 4. Information on the Company B “Background—CVac Clinical Development for the Treatment of Ovarian Cancer Patients in Remission” for more information.

 

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Patent Portfolio

The following table presents our portfolio of patents and patent applications, including their status (as at June 30, 2016) and title.

 

Patent

Family

  

Title

  

Status

  

Expires

Family 251 (Serono)

   Proteins produced by human lymphocytes, DNA sequences coding these proteins and pharmaceutical and biological uses thereof    Granted x2 USA    June 2015 and Feb 2016

Family 299 (Serono)

   LAG-3 protein soluble polypeptide fractions, methods of production, therapeutic composition and anti-idiotype antibody    Granted: Australia, Sth Africa, Norway, Europe, Japan, Republic of Korea, Mexico, Canada, China, Israel, Russian Federation, Singapore, USA x3    Sept 2016

Family 308 (Serono)

   Methods for detecting, isolating and selectively labelling and targeting TH1 lymphocytes by means of LAG-3 protein    Australia, Europe, Israel, USA    July 2016

Family 338 (Serono)

   Mutants of LAG-3 proteins, products of the expression of these mutants and use    Granted USA    Nov 2017

Family 356 (Serono)

   Use of MHC Class II ligands as adjuvant for vaccination and of LAG-3 in cancer treatment    Granted Europe x2, Canada x2, Israel, Japan, Republic of Korea, Singapore, Australia, China, Hong Kong, Mexico, USA x 2    Sept 2018

Family 400 (IGRD and Paris XI)

   Molecules binding to Glu-Pro motifs, therapeutical compositions containing them and their applications    Granted Europe    2021

Family 500 (Immutep)

   Vaccine composition comprising a class II MHC ligand couples with an antigen, method for the preparation and the use thereof    Granted Canada, Europe, Japan, USA(pending)    2025

Family 550 (Joint with INSERM)

   Cytotoxic anti-LAG-3 monoclonal antibody and its use in the treatment or prevention of organ transplant rejection and autoimmune disease   

Pending Canada, China, Europe, Japan,

Granted USA

   2028

Family 600 (Immutep)

   Compositions containing LAG-3 and cells that secrete GM-CSF and the methods of use    Granted USA    2028

Family 650

   Use of recombinant LAG-3 or the derivatives thereof for eliciting monocyte immune response   

Pending China, Europe (x4), Japan (x1), USA

Granted Australia, Europe and Japan

   2028

Family 660

   Combined preparations for the treatment of cancer    Pending PCT    Oct 2028

Family 670

   Combination of IMP321 and a checkpoint inhibitor    Pending PCT    2034

Family 700 (Novartis)

   Antibody molecules to LAG-3 and uses thereof    National Phase being pursued globally by Novartis    2035

Family 710

   Undisclosed    Provisional Application    N/A

Family 3

        

Ex vivo cell therapy

   Method of producing dendritic cells pulsed with MFP (family 1).    Granted in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Ireland, Japan (x2), Luxemburg, Spain, Sweden, Switzerland, Netherlands, Canada, USA and UK.   

2018

(expires 2022 in USA)

 

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Competition

We expect to face competition from other pharmaceutical companies and academic institutions that are developing comparable products including LAG-3 antibodies, checkpoint activators/inhibitors, cell therapies and other cancer treatments. We believe the competitive position of Prima BioMed in the face of such competition will be driven by a number of factors including the safety and efficacy of IMP321 compared with competitor products, the price value analysis, adoption by patients and physicians, timing of entry into the market in each indication, and the timing of regulatory approvals and influence of regulatory approvals such as orphan designation. The need to continuously improve and optimize manufacturing costs is also expected to be crucial to remaining competitive.

Current treatments for metastatic breast cancer include chemotherapies/cytotoxics, parp inhibitors, angiogenesis inhibitors and immunotherapies. The competitive space for checkpoint inhibitors, including LAG-3, is constantly growing. IMP321 is a first in class antigen presenting cell activator with limited direct competition. The Company believes there is significant potential for combining an immune activator with other treatment modalities including chemotherapies and checkpoint inhibitors to achieve enhanced therapeutic success.

There are a number of companies developing antagonist LAG-3 antibodies that are more advanced than that being developed by Novartis but the safety and efficacy of these candidates remains to be seen. As far as we are aware, there are currently no other companies developing depleting LAG-3 antibodies other than GSK

Regulatory Authorities

Our ongoing research and development activities, production, and marketing of our pharmaceutical product is subject to regulation by numerous governmental authorities, including (i) in Australia, principally the Therapeutics Goods Administration, or TGA; (ii) in the United States, principally the Food and Drug Administration, or FDA; and (iii) in Europe, principally the European Medicines Agency, or EMEA.

United States

Government oversight of the pharmaceutical industry is usually classified into pre-approval and post-approval categories. Most of the therapeutically significant innovative products marketed today are the subject of New Drug Applications, or NDAs, or Biologics License Applications, or BLAs. Preapproval activities, based on these detailed applications, are used to assure the product is safe and effective before marketing.

In the United States, The Centre for Biologics Evaluation and Research, or CBER, is the FDA organization responsible for vaccines, blood and biologics evaluation and approval. The FDA may inspect and audit the development facilities, planned production facilities, clinical trial sites and laboratory facilities. After the product is approved and marketed, the FDA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of production and quality control facilities by FDA’s field investigators and analysts.

 

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Federal Food, Drug and Cosmetic Act and Public Health Service Act

Prescription drug and biologic products are subject to extensive pre- and post-market regulation by the FDA, including regulations that govern the testing, manufacturing, safety, efficacy, labeling, storage, record keeping, advertising and promotion of such products under the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, and their implementing regulations. The process of obtaining FDA approval and achieving and maintaining compliance with applicable laws and regulations requires the expenditure of substantial time and financial resources. Failure to comply with applicable FDA or other requirements may result in refusal to approve pending applications, a clinical hold, warning letters, civil or criminal penalties, recall or seizure of products, partial or total suspension of production or withdrawal of the product from the market. FDA approval is required before any new drug or biologic, including a new use of a previously approved drug, can be marketed in the United States. All applications for FDA approval must contain, among other things, information relating to safety and efficacy, stability, manufacturing, processing, packaging, labeling and quality control.

Biologic License Applications (BLAs)

The FDA’s BLA approval process generally involves:

 

    completion of preclinical laboratory and animal testing in compliance with the FDA’s good laboratory practice, or GLP, regulations;

 

    submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin in the United States;

 

    performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the proposed biologic product for each intended use;

 

    satisfactory completion of an FDA pre-approval inspection of the facility or facilities at which the product is manufactured to assess compliance with the FDA’s cGMP regulations; and

 

    submission to and approval by the FDA of a BLA.

The manufacturing and quality, as well as preclinical and clinical testing and approval process requires substantial time, effort and financial resources, and we cannot guarantee that approval for our product candidate will be granted on a timely basis, if at all. Preclinical tests include laboratory evaluation of toxicity and immunogenicity in animals. The results of preclinical tests, together with manufacturing information and analytical data, are submitted as part of an IND application to the FDA. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns. Further, an independent institutional review board, or IRB, covering each medical center proposing to conduct clinical trials must review and approve the plan for any clinical trial before it commences at that center and it must monitor the study until completed. The FDA, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk. Clinical testing also must satisfy extensive Good Clinical Practice, or GCP, regulations, which include requirements that all research subjects provide informed consent and that all clinical studies be conducted under the supervision of one or more qualified investigators.

For purposes of an NDA submission and approval, human clinical trials are typically conducted in the following sequential phases, which may overlap:

 

    Phase I: Trials are initially conducted in a limited population to test the product candidate for safety and dose tolerance.

 

    Phase II: Trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, to determine the initial efficacy of the product for specific targeted indications and to determine dose tolerance and optimal dosage. Multiple Phase II clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more extensive Phase III clinical trials.

 

    Phase III: These are commonly referred to as pivotal studies. When Phase II evaluations demonstrate that a dose range of the product is effective and has an acceptable safety profile, Phase III clinical trials are undertaken in large patient populations to further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population at multiple, geographically-dispersed clinical trial sites. Generally, replicate evidence of safety and effectiveness needs to be demonstrated in two adequate and well-controlled Phase III clinical trials of a product candidate for a specific indication. These studies are intended to establish the overall risk/benefit ratio of the product and provide adequate basis for product labeling.

 

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    Phase IV: In some cases, the FDA may condition approval of a BLA on the sponsor’s agreement to conduct additional clinical trials to further assess the product’s safety, purity and potency after BLA approval. Such post-approval trials are typically referred to as Phase IV clinical trials.

Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and safety reports must be submitted to the FDA and the investigators for serious and unexpected adverse events. Concurrent with clinical studies, sponsors usually complete additional animal studies and must also develop additional information about the product and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods for testing the identity, strength, quality and purity of the final product. Moreover, appropriate packaging must be selected and tested and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

The results of product development, preclinical studies and clinical trials, along with the aforementioned manufacturing information, are submitted to the FDA as part of a BLA. BLAs must also contain extensive manufacturing information. Under the Prescription Drug User Fee Act, or PDUFA, the FDA agrees to specific goals for BLA review time through a two-tiered classification system, Standard Review and Priority Review. Standard Review is applied to products that offer, at most, only minor improvement over existing marketed therapies. Standard Review BLAs have a goal of being completed within a ten-month timeframe, although a review can take a significantly longer amount of time. A Priority Review designation is given to products that offer major advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes the FDA to review a BLA is six months. It is likely that our product candidate will be granted a Standard Review. The review process is often significantly extended by FDA requests for additional information or clarification. The FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations.

The FDA may deny approval of a BLA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or additional pivotal Phase III clinical trials. Even if such data are submitted, the FDA may ultimately decide that the BLA does not satisfy the criteria for approval. Data from clinical trials are not always conclusive and the FDA may interpret data differently than we do. Once issued, product approval may be withdrawn by the FDA if ongoing regulatory requirements are not met or if safety problems occur after the product reaches the market. In addition, the FDA may require testing, including Phase IV clinical trials, Risk Evaluation and Mitigation Strategies, or REMS, and surveillance programs to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs. Products may be marketed only for the approved indications and in accordance with the provisions of the approved label. Further, if there are any modifications to the drug, including changes in indications, labeling or manufacturing processes or facilities, approval of a new or supplemental BLA may be required, which may involve conducting additional preclinical studies and clinical trials.

Other U.S. Regulatory Requirements

After approval, products are subject to extensive continuing regulation by the FDA, which include company obligations to manufacture products in accordance with GMP, maintain and provide to the FDA updated safety and efficacy information, report adverse experiences with the product, keep certain records and submit periodic reports, obtain FDA approval of certain manufacturing or labeling changes and comply with FDA promotion and advertising requirements and restrictions. Failure to meet these obligations can result in various adverse consequences, both voluntary and FDA-imposed, including product recalls, withdrawal of approval, restrictions on marketing, and the imposition of civil fines and criminal penalties against the BLA holder. In addition, later discovery of previously unknown safety or efficacy issues may result in restrictions on the product, manufacturer or BLA holder.

We, and any manufacturers of our products, are required to comply with applicable FDA manufacturing requirements contained in the FDA’s GMP regulations. GMP regulations require, among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation. The manufacturing facilities for our products must meet GMP requirements. We, and any third-party manufacturers, are also subject to periodic inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations.

With respect to post-market product advertising and promotion, the FDA imposes a number of complex regulations on entities that advertise and promote pharmaceuticals, which include, among others, standards for direct-to-consumer advertising, promoting products for uses or in patient populations that are not described in the product’s approved labeling (known as “off-label use”), industry-sponsored scientific and educational activities, and promotional activities involving the Internet. Failure to comply with FDA requirements can have negative consequences, including adverse publicity, enforcement letters from the FDA, mandated corrective advertising or communications with doctors and civil or criminal penalties. Although physicians may prescribe legally available drugs for off-label uses, manufacturers may not market or promote such off-label uses.

 

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Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval of a new BLA or BLA supplement before the change can be implemented. A BLA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing BLA supplements as it does in reviewing BLAs.

Adverse event reporting and submission of periodic reports is required following FDA approval of a BLA. The FDA also may require post-marketing testing, known as Phase IV testing, risk mitigation strategies, and surveillance to monitor the effects of an approved product or place conditions on an approval that could restrict the distribution or use of the product.

European Union

In addition to regulations in the United States, we are subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. The approval process varies from country to country and the time may be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials vary greatly from country to country.

Under European Union regulatory systems, we must submit and obtain authorization for a clinical trial application in each member state in which we intend to conduct a clinical trial. After we have completed our clinical trials, we must obtain marketing authorization before we can market our product. We may submit applications for marketing authorizations either under a centralized or decentralized procedure. The centralized procedure provides for the grant of a single marketing authorization that is valid for all European Union member states. The decentralized procedure provides for mutual recognition of national approval decisions. Under this procedure, the holder of a national marketing authorization may submit an application to the remaining member states. Within 90 days of receiving the applications and assessment report, each member state must decide whether to recognize approval. If a member state objects to the approval, an arbitration process is initiated and the final decision is made by the European Commission on the basis of an opinion of the Committee for Proprietary Medicinal Products for Human Use, or CHMP. The mutual recognition procedure may be used more than once for subsequent applications to other member states in relation to the same product candidate.

The European Medicines Agency, or EMA, is a decentralized body of the European Union located in London. The EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. The EMA is involved in the scientific evaluation of medicines that fall within the scope of the centralized procedure. However, other medicines that do not fall within this scope are marketed in the European Union either in individual member states, in accordance with their national authorization procedures, or in multiple member states through the decentralized or mutual-recognition procedures. The EMA only becomes involved in the assessment of such medicines when they have been referred to the EMA due to a disagreement between two or more member states about the authorization or use of the medicine, or due to some other issue that requires resolution in the interest of protecting public health. Like the FDA there is a harmonization between regulators and the EMA may inspect and audit the development facilities, planned production facilities, clinical trial sites and laboratory facilities. Additionally, after the product is approved and marketed, the EMA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the product is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of production and quality control facilities.

Australia

In Australia, the relevant regulatory body responsible for the pharmaceutical industry is the Therapeutics Goods Administration, or TGA. As with the EMA and FDA there is a harmonization and collaboration between regulatory authorities. The CTN filing in Australia references the US FDA IND but separately requires a TGA manufacturing authorization to permit manufacture of products in Australia.

Third-Party Payer Coverage and Reimbursement

Although our product candidate has not been commercialized for any indication, if they are approved for marketing, commercial success of our product candidate will depend, in part, upon the availability of coverage and reimbursement from third-party payers at the federal, state and private levels.

 

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Inflation and Seasonality

Management believes inflation has not had a material impact on our operations or financial condition. Management further believes that our operations are not currently subject to seasonal influences due to our current lack of marketed products. Moreover, cancer, which is the target of our products, is not a seasonal disease. Accordingly, once we have marketed products, management does not expect that our business will be subject to seasonal influences.

Manufacturing and Raw Materials

Prima BioMed has no manufacturing capabilities and is dependent on third parties for cost effective manufacture and manufacturing process development of their product candidates. Problems with third party manufacturers or the manufacturing process as such may delay clinical trials and commercialization of Prima BioMed’s product candidates.

Biological product candidates like CVac, IMP731, IMP701 or IMP321 usually have more complicated manufacturing procedures than chemically produced therapies. The change of manufacturing partners, manufacturing process changes or changes of other nature could impact the product quality and affect the comparability of different product batches. A lack of comparability could significantly impact the development timelines and could even lead to a situation where regulatory bodies require additional or new pre-clinical or clinical development.

C. Organizational Structure

Our research and development activities were initially conducted via four wholly owned Australian subsidiaries but as these activities ceased in July 2010 we deregistered these subsidiaries. Oncomab Pty Ltd, Panvax Pty Ltd and Arthron Pty Ltd were deregistered on July 31, 2013 and Cancer Vac Pty Ltd was deregistered on 18 July 2014. Below is a list of the current subsidiaries of Prima BioMed Ltd., including our ownership percentage, its date of formation and its jurisdiction. These subsidiaries were established to allow us to conduct commercial and clinical operations in Europe and the United States and expand our operations in Australia.

 

Subsidiary

   Ownership  

Date of Formation/Acquisition

   Jurisdiction

Prima BioMed USA Inc.

   100%   April 2010 (formed)    United States

Prima BioMed GmbH

   100%   September 2010 (formed)    Germany

Prima BioMed Australia Pty Ltd

   100%   November 2011 (formed)    Australia

Prima BioMed IP Pty Ltd

   100%   November 2011 (formed)    Australia

Immutep S.A.S

   100%   December 2014 (acquired)    France

Prima BioMed Middle East FZ LLC is in the process of being dissolved as Prima ceased to conduct clinical trials within the UAE.

D. Property, Plants and Equipment

We own computer equipment, office furniture and laboratory equipment, which is primarily placed at our own offices and laboratories.

 

ITEM 4A. UNRESOLVED STAFF COMMENTS

None.

 

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ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS

A. Operating Results

Foreign Currency Risk

The group operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the US dollar and Euro.

The group seeks to minimize potential adverse effects on the financial performance of the group. The group considers using derivative financial instruments such as foreign exchange contracts to hedge certain risk exposures or using natural hedging. Derivatives are exclusively used for hedging purposes, i.e. not as trading or other speculative instruments. There were no derivative financial instruments held by the company as at 30 June 2016, 30 June 2015 and 30 June 2014.

Governmental Policies

Our ongoing research and development activities, production, and marketing of our pharmaceutical product is subject to regulation by numerous governmental authorities: (i) in Australia, principally the Therapeutics Goods Administration, or TGA; (ii) in the United States, principally the Food and Drug Administration, or FDA; and (iii) in Europe, principally the European Medicines Agency, or EMA. Also, our ability to commercially exploit our products successfully will depend in part on the extent to which reimbursement for the cost of our products and related treatment will be available from government health administration authorities, private health coverage insurers and other organizations.

The Australian Government tax incentive scheme relating to eligible research and development activities is expected to provide us with significant benefits in future years. Such eligible R&D activities include but are not limited to:

a. Core activities, which are experimental activities whose outcome cannot be known or determined in advance, but can only be determined by applying a systematic progression of work;

b. Core activities conducted for the purpose of generating new knowledge (including new knowledge in the form of new or improved processes and materials); or

c. Supporting activities that are directly related and designed to support the above (a) and (b).

For further information regarding governmental economic, fiscal, monetary or political policies or factors that have materially affected, or could materially affect, our operations or our shareholders’ investments, see Item 3. Key Information D “Risk Factors – Risks Related to Our Business,” “– Risks Relating to Our Location in Australia” —“Item 10. Additional Information – D “Exchange Controls” and “E Taxation.”

Background

Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.

Prima’s main pipeline of products is based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. The most clinically advanced product is a T cell immunostimulatory factor (APC activator), IMP321, for cancer chemoimmunotherapy which has completed early Phase II trials. A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.

In addition, Prima has significantly developed infrastructure for a cell-based therapy manufacturing platform and taken CVac™, an autologous dendritic cell-based product through Phase II clinical trials for ovarian cancer patients in remission. For a description of the milestones that we have achieved since inception and through June 2014, see “Item 4. Information on the Company—A. History and Development of the Company.”

Overview

We are a development stage enterprise at an early stage in the development of our product candidate. We have incurred net losses since inception and expect to incur substantial and increasing losses for the next several years as we expand our research and development activities and move our product candidate into later stages of development. The process of carrying out the development of our products to later stages of development may require significant additional research and development expenditures, including pre-clinical testing and clinical trials, as well as for obtaining regulatory approval. To date, we have funded our operations primarily through the sale of equity securities, proceeds from the exercise of options, grants and interest income. For details of the business overview, see “Item 4. Information on the Company—B. Business Overview.”

 

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Critical Accounting Policies and Estimates

Estimates and judgements are continually evaluated and are based on historical experience and other factors, including expectations of future events that may have a financial impact on the entity and that are believed to be reasonable under the circumstances.

The group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.

Income taxes

The group has recognized deferred tax assets of $2.42m which related to carried forward tax losses in the Immutep subsidiary acquired in the prior year. On acquisition, the group has recognized significant amortizing IP intangibles for which there will be no corresponding tax deduction, giving rise to a future taxable temporary difference and required the recognition of a deferred tax liability as part of the business combination accounting. The entity had previously unrecognized tax losses which management is satisfied will continue to be available to be utilized by the subsidiary after the acquisition. As such, the group has recognized a deferred tax asset to the extent of the deferred tax liability recognized on acquisition. The group has concluded that the deferred assets will be recoverable using the estimated future taxable income based on the approved business plans and budgets for the subsidiary.

All other remaining deferred tax assets relating to carried forward tax losses and taxable temporary differences have not been recognised since the group is currently in a loss making position and unable to generate taxable income to utilise the carried forward tax losses and taxable temporary differences. The utilisation of the tax losses also depends on the ability of the entity to satisfy certain tests at the time the losses are recouped. The group is subject to income taxes in Australia and jurisdictions where it has foreign operations. Significant judgement is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The group estimates its tax liabilities based on the group’s understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.

Research and development

The consolidated entity has expensed all internal research and development expenditure incurred during the year as the costs relate to the initial expenditure for research and development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the current stage of development. It was considered appropriate to expense the research and development costs as they did not meet the criteria to be capitalized under AASB 138 Intangible Assets (IAS 38) .

Going concern

The Group has experienced significant recurring operating losses and negative cash flows from operating activities since its inception. As at 30 June 2016, the Group holds cash and cash equivalents of A$20,879,548, compared with A$6,759,615 as at 30 June 2015. In line with the Company’s financial risk management, the directors have carefully assessed the financial and operating implications of the above matters, including the expected cash outflows of ongoing research and development activities of the Company over the next 12 months. Based on this consideration, the directors are of the view that the Group will be able to pay its debts as and when they fall due for at least 12 months following the date of these financial statements and that it is appropriate for the financial statements to be prepared on a going concern basis.

Monitoring and addressing the ongoing cash requirements of the Group is a key focus of the directors. This involves consideration of alternative future capital raising initiatives and an active engagement with potential retail and institutional investors alike.

 

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Amortization of intellectual property

Costs incurred in acquiring intellectual property are capitalized and amortized on a straight line basis over a period not exceeding the life of the patents, which averages 15 years. Where a patent has not been formally granted, the company estimates the life of the granted patent in accordance with the provisional application.

Costs include only those costs directly attributable to the acquisition of the intellectual property. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (note 1(h)).

Results of Operations

Comparison of Fiscal Year Ended June 30, 2016 to Fiscal Year Ended June 30, 2015

Revenue

The license revenue for fiscal year 2016 was A$0.2 and nil for fiscal year 2015. The increase of A$0.2 was attributable to revenue received in relation to an out-licensing deal of one of the company’s Intellectual Property assets.

Other Income

Other income decreased to A$1.9 million for fiscal year 2016 from A$2.1 million for fiscal year 2015, a decrease of A$0.2m, or 11.4%. Other income consists of interest income, cash tax rebates, grant income, gain on foreign exchange and other miscellaneous income. The interest income for fiscal year 2016 was A$0.3 million and A$0.2 million for fiscal year 2015. The increase in interest income in fiscal year 2016 is due to an increase in the level of cash held on term deposits and a decrease in interest rates on term deposits. Income from cash tax rebates and grant income from the Saxony Development Bank related to eligible research and development expenditures consists of A$0.9 million and A$1.2 million for fiscal year 2016 and fiscal year 2015, respectively. The decrease of A$0.3 million was attributable to the reduction in the Research & Development expenditure in fiscal year 2016 compared to fiscal year 2015. No foreign exchange gain was recognized in 2016 compared to a gain of A$0.5 million for fiscal year 2015, which was driven by the impact of changes in our U.S. and Euro cash holdings compared to the prior year.

Research & Development and Intellectual Property Expenses

Research and development and intellectual property expenses decreased to A$7.1 million for fiscal year 2016 from A$9.0 million for fiscal year 2015, a decrease of A$1.9 million, or 21%. The decrease in research and development and intellectual property expenses in the fiscal year 2016 was due to the initiation of the two new clinical trials AIPAC and TACTI-mel, compared to the prior year which related to the cessation of the costly CVac clinical trials.

Corporate Administrative Expenses

Corporate administrative expenses increased to A$7 million for fiscal year 2016 from A$5.7 million for fiscal year 2015, an increase of A$1.3 million, or 22%. The increase in corporate administrative expenses was attributable to an increase in employee share-based payment expenses in fiscal year 2016 of A$1.97 million compared to A$0.7 million in fiscal year 2015.

Depreciation and Amortization Expenses

Depreciation and amortization expenses increased to A$2.0 million for fiscal year 2016 from A$1.3m for fiscal year 2015, an increase of A$0.7m, or 49%. The increase is attributable to amortization costs incurred on Intellectual Property Assets acquired on the purchase of Immutep covering the full year in fiscal year 2016 compared to the part of fiscal year 2015.

Loss on foreign exchange

Loss on foreign exchange was $0.6m for fiscal year 2016 compared to nil for fiscal year 2015, which was driven by the impact of changes in exchange rates on our U.S. and Euro cash holdings compared to the prior year.

Share Based Payment to strategic investor

The Share Based Payment to strategic investor expense was A$47.5m for fiscal year 2016 compared to nil in fiscal year 2015. The amount represents the difference between the fair value of convertible notes and warrants issued to Ridgeback Capital Investments and the cash received. Due to additional benefits being provided by Ridgeback, the difference has been expensed on grant date in accordance with AASB 2 (IFRS 2) . Refer to note 15 to the consolidated financial statements for further information.

 

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Finance cost

Finance costs of A$0.01 million were incurred during fiscal year 2016 compared to A$18.3 million in fiscal year 2015. The decrease was attributable to our procurement of funding from Bergen Global Opportunity Fund, LP for the acquisition of Immutep in fiscal year 2015. This funding was repaid before the end of fiscal year 2015. The interest expense incurred in fiscal year 2016 related to other borrowings which were repaid in August 2015.

Changes in fair value of comparability milestone

Changes in fair value of comparability milestone of A$0.5 million were incurred during fiscal year 2016 compared to nil in fiscal year 2015. This relates to an amount paid into a retention account on the acquisition of Immutep which was measured through fair value through profit and loss in accordance with AASB 3 (IFRS 3). Refer to note 21 to the consolidated financial statements for further information.

Net change in fair value of convertible note liability

Net change in fair value of convertible note liability of A$0.6 million were incurred during fiscal year 2016 compared to nil in fiscal year 2015. The increase was attributable to the liability component of the convertible note being measured at fair value as required by AASB 2 (IFRS 2) . Refer to note 15 to the consolidated financial statements for further information.

Net Loss

Net loss increased to A$62.0 million for fiscal year 2016 from A$32.2 million for fiscal year 2015.

Comparison of Fiscal Year Ended June 30, 2015 to Fiscal Year Ended June 30, 2014

Other Income

Other income increased to A$2.1 million for fiscal year 2015 from A$3.1 million for fiscal year 2014, a decrease of A$1m, or 32%. Other income consists of interest income, cash tax rebates, grant income, gain on foreign exchange and other miscellaneous income. The interest income for fiscal year 2015 was A$0.2 million and A$0.7 million for fiscal year 2014. The decrease in interest income in fiscal year 2015 is due to the significant decrease in the level of cash held on term deposits and a decrease in interest rates on term deposits. Income from cash tax rebates and grant income from the Saxony Development Bank related to eligible research and development expenditures consists of A$1.2 million and A$2.0 million for fiscal year 2015 and fiscal year 2014, respectively. The decrease of A$0.8 million was attributable to a commensurate decrease in Research & Development expenditure in fiscal year 2015 compared to fiscal year 2014. The foreign exchange gains of A$0.5 million for fiscal year 2015 and A$0.4 million for fiscal year 2014 was driven by the impact of changes in our U.S. and Euro cash holdings.

Research & Development and Intellectual Property Expenses

Research and development and intellectual property expenses decreased to A$9.0 million for fiscal year 2015 from A$12.0 million for fiscal year 2014, a decrease of A$3.0 million, or 25%. The decrease in research and development and intellectual property expenses in the fiscal year 2015 was the result of consolidating our research and development work into Europe from the United States as well as ceasing further clinical development of CVac assets.

Corporate Administrative Expenses

Corporate administrative expenses increased to A$5.7 million for fiscal year 2015 from A$4.1 million for fiscal year 2014, an increase of A$1.6 million, or 39%. The increase in corporate administrative expenses was attributable to the acquisition of Immutep S.A. in this past fiscal year including due diligence and related transaction costs, investment banking and legal expenses.

Depreciation and Amortization Expenses

Depreciation and amortization expenses were A$1.4 million for fiscal year 2015, compared to A$0.4 million in fiscal year 2014. The increase is attributable to the amortization of acquired intellectual property assets.

 

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Changes in Fair Value of Derivative Financial Instruments

Changes in fair value of derivative financial instruments expenses was nil for fiscal year 2015, which was roughly equivalent to fiscal year 2014. There were no foreign hedging contracts entered into as at June 30, 2015 and as at June 30, 2014.

Finance cost

Finance costs of A$18.3 million were incurred during fiscal year 2015 compared to no costs in fiscal year 2014. The increase was attributable to our procurement of funding from Bergen Global Opportunity Fund, LP for the acquisition of Immutep in fiscal year 2015. This funding was repaid before the end of fiscal year 2015.

Net Loss

Net loss increased to A$32.2 million for fiscal year 2015 from A$13.3 million for fiscal year 2014.

New Accounting Standards and Interpretations Not Adopted

New and amended standards adopted by the group

Certain new accounting standards and interpretations have been published that are not mandatory for 30 June 2016 reporting periods and have not been early adopted by the company. The company’s assessment of the impact of these new standards and interpretations is set out below:

 

  (i) AASB 15 (IFRS 15) Revenue from Contracts with Customers—The AASB has issued a new standard for the recognition of revenue. This will replace AASB 118 (IAS 18) which covers revenue arising from the sale of goods and the rendering of services and AASB 111 (IAS 11) which covers construction contracts. The new standard is based on the principle that revenue is recognized when control of a good or service transfers to a customer. The standard permits either a full retrospective or a modified retrospective approach for the adoption. It applies to annual reporting periods commencing on or after 1 January 2018. Management has performed a preliminary assessment of the impact of the new standard and has not identified any instances where the new standard requirements will have a material impact on the financial statements of the Company.

 

  (ii) AASB 9 (IFRS 9) Financial Instruments—AASB 9 (IFRS 9) addresses the classification, measurement and derecognition of financial assets and financial liabilities, introduces new rules for hedge accounting and a new impairment model for financial assets. It applies to annual reporting periods commencing on or after 1 January 2018. Management has performed a preliminary assessment of the impact of the new standard and has not identified any instances where the new standard requirements will have a material impact on the financial statements of the Company.

 

  (iii) AASB 16 (IFRS 16) Leases—The AASB 16 (IFRS 16) has issued a new standard for the accounting of leases. The new standard will predominantly affect lessees, with almost all leases brought onto the balance sheet. It applies to annual reporting periods commencing on or after 1 January 2019. Management has performed a preliminary assessment of the impact of the new standard and has not identified any instances where the new standard requirements will have a material impact on the financial statements of the Company.

There are no other standards and interpretations that are not yet effective and that are expected to have a material impact on the Group in the current or future reporting periods and on foreseeable future transactions.

B. Liquidity and Capital Resources

Since our inception, our operations have mainly been financed through the issuance of equity securities. Additional funding has come through convertible loans, operating grants and interest earned from cash on term deposit.

Equity Issuances

The following table summarizes our issuances of ordinary shares for cash, excluding share-based payments, executive and employee compensation in the last five fiscal years.

 

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     Fiscal
Year
     Number of
Shares/Options
     Net Proceeds  
                   (in A$)  

Ordinary Shares – private placement, share purchase plan, repayment of convertible loans and exercise of options

     2010         278,662,654         21,430,975   

Ordinary Shares – private placement, share purchase plan, repayment of convertible loans and exercise of options

     2011         280,428,034         55,067,573   

Ordinary Shares – exercise of options and share issuance

     2012         85,047,759         1,820,455   

Ordinary Shares – share purchase plan

     2013         77,083,450         6,166,676   

Listed Options – option entitlement offer

     2013         77,378,699         1,547,574   

Ordinary Shares – share purchase plan

     2014         85,562,503         6,845,001   

Ordinary Shares – private placement, repayment of convertible loans and exercise of performance rights and options

     2015         522,785,260         31,028,380   

Ordinary Shares – private placement, share purchase plan and exercise of performance rights and options

     2016         310,136,343         14,935,642   

Capital Requirements

As of June 30, 2016, we had year-end cash and cash equivalents of A$20.9 million. We anticipate that our current cash and cash equivalents will be sufficient to fund our operations for more than 12 months from the date of this filing. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. If we are unable to raise additional capital when required or on acceptable terms, we may have to significantly delay, scale back or discontinue one or more of our clinical trials or our operations.

We anticipate that we will require substantial additional funds in order to achieve our long-term goals and complete the research and development of our current principal pharmaceutical product candidates. We do not expect to generate significant revenue until we obtain regulatory approval to market and sell our product candidate and sales of our product candidate have commenced. We therefore expect to continue to incur substantial losses in the near future. Our future capital requirements are difficult to forecast and will depend on many factors, including:

 

    the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

    the scope, results and timing of preclinical studies and clinical trials;

 

    the costs and timing of regulatory approvals; and

 

    the costs of establishing sales, marketing and distribution capabilities

Cash Flows

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

 

     Fiscal Year Ended June 30,  
     2016      2015      2014  
     A$      A$      A$  

Net cash used in operating activities

     (11,309,691      (7,786,982      (14,227,161

Net cash provided by (used in) investing activities

     102,575         (11,961,411      (1,103,675

Net cash provided by financing activities

     25,720,284         11,268,429         6,687,395   

Net increase (decrease) in cash and cash equivalents

     14,513,168         (8,479,964      (8,643,441

Effect of exchange rate on cash and cash equivalents

     (393,235      1,039,537         820,340   

Cash and cash equivalents at beginning of period

     6,759,615         14,200,042         22,023,143   

Cash and cash equivalents at end of period

     20,879,548         6,759,615         14,200,042   

 

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Operating Activities

Net cash used in operating activities was A$11.3 million, A$7.8 million, and A$14.2 million during fiscal years 2016, 2015 and 2014, respectively. Payments to suppliers and employees account for almost all of the amounts above for R&D and administrative purposes. Net cash used in operating activities reduced during fiscal year 2015 due to the ceasing the CVac program and has increased in fiscal year 2016 as the AIPAC and TACTI-mel clinical trials were initiated. During fiscal years 2016, 2015 and 2014, our payments to suppliers and employees were offset by interest income received of A$0.3 million, A$0.2 million, and A$0.7 million, respectively, and grant income received of A$0.9 million, A$1.2 million, and A$2.0 million, respectively.

Investing Activities

Net cash provided by investing activities was A$0.1 million during fiscal year 2016, while net cash used in investing activities was A$12.0 million, and A$1.1 million during fiscal years 2015 and 2014, respectively. The cash inflow in fiscal year 2016 was a result of the sale of plant and equipment. The net cash outflow for fiscal year 2015 increased as a result of the acquisition of Immutep S.A.S.

Financing Activities

Net cash provided by financing activities was A$27.5 million, A$11.3 million, and A$6.7 million for fiscal years 2016, 2015 and 2014. Net cash provided by financing activities during (i) fiscal 2016 was primarily attributable to the issue of shares attributable to a share purchase plan (A$10 million) and attributable to private placements to institutional investor s (A$3.8 million) and the issue of convertible notes (A$13.7 million), (ii) fiscal 2015 was primarily attributable to the issue of shares (A$4.0 million), the issue of convertible notes (A$2.9 million) the exercise of warrants (A$2.6 million) and conversion of convertible notes (A$1.1 million), and (iii) fiscal 2014 was primarily attributable to a share purchase plan (A$6.7 million).

At June 30, 2016 we had A$20.9 million in cash and cash equivalents compared with 2015, where we had A$6.8 million in cash and cash equivalents. At June 30, 2014, we had A$14.2 million in cash and cash equivalents plus A$9.0 million on a term deposit.

C. Research and Development, Patents and Licenses

For a description of our research and development programs and activities, see “Item 4. Information on the Company—B—. Business Overview—Background”. For a description of the amount spent during each of the last three fiscal years on company-sponsored research and development activities, as well as the four components of research and development expenses, see “Item 5. Operating and Financial Review and Prospects—A. Operating Results—Results of Operations.”

D. Trend Information

We are a development stage company and it is not possible for us to predict with any degree of accuracy the outcome of our research or commercialization efforts.

Our research and development expenditure is our primary expenditure. Increases or decreases in research and development expenditure are attributable to the level of clinical trial activity and the amount of expenditure on those trials. The main clinical trials are the AIPAC 211 patient Phase IIb study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 as an adjuctive to a standard chemotherapy treatment regimen of paclitaxel. In addition the pilot Phase 1 TACTI-mel study for patients with unresectable or metastatic melanoma will be dosed with IMP321 in combination with an approved checkpoint inhibitor.

It is expected that as we activate new clinics and recruit more patients for our current clinical trials, that our R&D expenses will increase over the coming year.

E. Off-Balance Sheet Arrangements

During fiscal years 2013, 2014, 2015 and 2016, 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. Tabular Disclosure of Contractual Obligations

As of June 30, 2016 our contractual obligations were as set forth below:

 

     Payments Due by Period  

Contractual maturities of financial liabilities

   Less than
6 months
     More than
5 years
     Total
contractual
cash flows
 
     $      $      $  

Non-Derivatives

        

Trade and other payables

     1,422,798         —          1,422,798   

Convertible note liability (refer note 15)

     —          17,876,076         17,876,076   
  

 

 

    

 

 

    

 

 

 
     1,422,798         17,876,076         19,298,874   
  

 

 

    

 

 

    

 

 

 

We have agreements with clinical sites and contract research organizations. We make payments to these sites and organizations based upon the number of patients enrolled and the period of follow-up in the trial.

G. Safe Harbor

Special note regarding forward-looking statements

This Annual Report contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and section 21E of the U.S. Securities Exchange Act of 1934, as amended, including assumptions, anticipations, expectations and forecasts concerning the Group’s future business plans, products, services, financial results, performance, future events and information relevant to our business, industries and operating environments. When used in this document, the words ‘anticipate’, ‘believe’, ‘estimate’, ‘assume’, ‘could’, ‘should’, ‘expect’ and similar expressions, as they relate to the Group or its management are intended to identify forward-looking environments. Such statements reflect the current views of management with respect to future events and are subject to certain risks, uncertainties and assumptions. The forward-looking statements contained herein represent a good-faith assessment of our future performance for which we believe there is a reasonable basis. Many factors could cause the actual results, performance or achievements of the Group to be materially different from any future results, performance or achievements that may be expresses or implied by such forward-looking statements, including, among others, adverse changes or uncertainties in economic conditions that affect the markets we serve and the risks as described in Item 3D. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

These forward-looking statements represent our view only as of the date they are made and we disclaim any obligation to update forward-looking statements contained herein, except as may be otherwise required by law.

 

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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 September 1, 2016.

 

Name

  Age     

Position

Lucy Turnbull AO(1)

    58      

Non-Executive Chairman

Albert Wong (2)

    57      

Non-Executive Deputy Chairman

Pete Meyers (3)

    46      

Non-Executive Director

Russell Howard, Ph.D.(4)

    66      

Non-Executive Director

Marc Voigt

    43      

Executive Director, Chief Executive Officer, Chief Financial Officer and Chief Business Officer

Frédéric Triebel

    61      

Chief Scientific Officer & Chief Medical Officer

Deanne Miller

    39      

General Counsel & Company Secretary

 

(1)   Chair of the Remuneration Committee and member of the Audit & Risk Committee.
(2)   Member of the Remuneration Committee and Audit & Risk Committee.
(3)   Chair of the Audit & Risk Committee.
(4)   Member of the Remuneration Committee

Ms. Lucy Turnbull AO. Ms. Turnbull has served as Chairman of our Board of Directors since October 2010. She is an urbanist, businesswoman and philanthropist with longstanding interest in cities and their planning and technological and social innovation. She chaired ASX listed WebCentral Ltd from 2004-06 when it was acquired by ASX listed Melbourne IT Limited. She was a director of Melbourne IT from 2006-2010 and was a director of Sealink Travel Group Ltd in 2015. She is Chief Commissioner of the Greater Sydney Commission and chairs the Committee for Sydney. She was previously Deputy Chair of the COAG Reform Council’s Cities Expert Panel advising on its Metropolitan Strategic Planning Report. She was the first female Lord Mayor of the City of Sydney from 2003-4 and before that was Deputy Mayor from 1999-2003. She was a board member of the Cancer Institute of NSW and the Australian Technology Park, Redfern. In 2012 she was awarded an Honorary Doctorate of Business by the University of NSW for her contribution to business, philanthropy and local government. In 2011 she became an Officer of the Order of Australia for distinguished service to the community, local government and business.

Mr. Albert Wong . Mr. Wong has served as a Director of Prima BioMed since April 2010 and is the Deputy Chairman. Originally from Hong Kong, Mr Wong has been involved in the investment banking and stockbroking industry for some 35 years. He has and continues to serve on various boards including Founding Chairman of Kyckr Limited and is an adviser to China’s Nanshan Group and is an alternate director representing their interests on the Virgin Australia board. Albert’s philanthropic activities include serving on the boards of UNSW Foundation, The Children’s Medical Research Institute and President and Honorary Life Governor of the Physics Foundation at the University of Sydney.

Mr. Pete Meyers. Mr. Meyers has served as a Director of Prima BioMed since February 2014. He is currently the Chief Financial Officer of Motif Bio plc. Previously, Mr. Meyers was the Chief Financial Officer of TetraLogic Pharmaceuticals Corporation. Prior to these roles, Mr. Meyers was an accomplished health care investment banker, holding a positions of increasing responsibility at Dillon, Read & Co., Credit Suisse First Boston LLC and, most recently, as Co-Head of Global Health Care Investment Banking at Deutsche Bank Securities Inc. In New York. Mr. Meyers earned a Bachelor of Science degree in finance from Boston College and a Master of Business Administration degree from Columbia Business School. Mr Meyers is currently also the Chairman and President of the Thomas M Brennan Memorial Foundation, Inc.

Dr. Russell Howard, Ph.D. Dr. Russell Howard has served as a Director of Prima BioMed since May 2013. He is an Australian scientist, executive manager and entrepreneur. He was a pioneer in molecular parasitology and commercialization of “DNA Shuffling”. He is an inventor of 9 patents and has over 150 scientific publications. After his PhD in biochemistry from the University of Melbourne, he held positions at several research laboratories, including the National Institutes of Health in the USA where he gained tenure. In industry, Dr. Howard worked at Schering-Plough’s DNAX Research Institute in Palo Alto, CA; was the President and Scientific Director of Affymax, Inc. and co-founder and CEO of Maxygen, Inc. after its spin-out from GlaxoWellcome. As Maxygen’s CEO, Dr. Howard led its IPO on NASDAQ and a secondary offering, raising US$ 260 million. Maxygen developed and partnered dozens of technology applications and products. After leaving Maxygen in 2008, he started the Cleantech company Oakbio, Inc. and remains involved in several innovative companies in the USA and Australia. He is currently Executive Chairman of NeuClone Pty Ltd and Head of Commercial Strategy for Genomics at Genome.One, both in Sydney.

 

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Mr. Marc Voigt. Mr. Voigt has served as our Chief Financial Officer and Chief Business Officer since 2012 and was appointed as CEO and Executive Director in July 2014. He has extensive experience in the corporate and biotechnology sectors. He joined Prima BioMed’s management team in 2011 as the General Manager of our European operations at Prima BioMed GmbH, where he currently serves as the Managing Director. He has previously worked as an investment manager for Allianz Insurance biotech venture fund, and as a personal assistant to a member of the Executive Board of Allianz Insurance. Mr. Voigt has also worked for German investment bank, net.IPO.AG, in the area of business development and German securities offerings. In the biotech sector, he has held the positions of CFO/CBO at Revotar Biopharmaceuticals AG and Medical Enzymes AG. He has a Masters Degree in Business Administration from the Freie Universität of Berlin, and is a member of the pharma licensing club Germany and a member of the judging panel of Germany’s largest business plan competition.

Dr. Frédéric Triebel , MD Ph.D., Dr Triebel is our Chief Scientific Officer and Chief Medical Officer and has been with Prima BioMed since December 2014, following the completion of the acquisition of Immutep. Dr Triebel was the scientific founder of Immutep S.A. (2001) and served as the Scientific and Medical Director at Immutep from 2004. Before starting Immutep, he was Professor in Immunology at Paris University. While working at Institut Gustave Roussy (IGR), a large cancer center in Paris, he discovered the LAG-3 gene in 1990 and continued working on this research program since then, identifying the functions and medical usefulness of this molecule. He headed a research group at IGR while also being involved in the biological follow-up of cancer patients treated in Phase I/II immunotherapy trials. He was Director of an INSERM Unit from 1991 to 1996. First trained as a clinical hematologist, Prof. Triebel holds a Ph.D. in immunology (Paris University) and successfully developed several research programs in immunogenetics and immunotherapy, leading to 144 publications and 16 patents.

Ms. Deanne Miller. Ms. Miller joined Prima BioMed as General Counsel and Company Secretary in October 2012. She has broad commercial experience having held legal, investment banking, regulatory compliance and tax advisory positions, including, Legal Counsel at RBC Investor Services, Associate Director at Westpac Group, Legal & Compliance Manager at Macquarie Group, Regulatory Compliance Analyst at the Australian Securities and Investment Commission, and Tax Advisor at KPMG. She joined Prima as General Counsel and Company Secretary in October 2012. She has a Combined Bachelor of Laws (Honours) and Bachelor of Commerce, Accounting and Finance (double major) from the University of Sydney. She is admitted as a solicitor in NSW and member of the Law Society of NSW.

B. Compensation

Remuneration Principles

Remuneration of all executive and non-executive directors and officers is determined by the Remuneration Committee.

We are committed to remunerating senior executives and executive directors in a manner that is market-competitive and consistent with “Best Practice” including the interests of shareholders. Remuneration packages are based on fixed and variable components, determined by the executives’ position, experience and performance, and may be satisfied via cash or equity.

Non-executive directors are remunerated out of the aggregate amount approved by shareholders and at a level that is consistent with industry standards. Non-executive directors do not receive performance based bonuses and prior shareholder approval is required to participate in any issue of equity. No retirement benefits are payable other than statutory superannuation, if applicable.

Our remuneration policy is not directly based on our financial performance, rather on industry practice, given we operate in the biotechnology sector and our primary focus is research activities with a long term objective of developing and commercializing the research and development results.

We envisage our performance in terms of earnings will remain negative while we continue in the research and development phase.

The purpose of a performance bonus is to reward individual performance in line with our objectives. Consequently, performance based remuneration is paid to an individual where the individual’s performance clearly contributes to a successful outcome. This is regularly measured in respect of performance against key performance indicators.

We use a variety of key performance indicators to determine achievement, depending on the role of the executive being assessed. These include:

 

    Successful contract negotiations.

 

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    Achievement of research project milestones within scheduled time and/or budget.

 

    Our share price reaching a targeted level on the ASX over a period of time.

Executive Compensation

The following table sets forth all of the compensation awarded to, earned by or paid to each individual who served as directors and executive officers in fiscal 2016.

 

June 30, 2016

  Short-term Benefits     Post
Employment
Benefits
    Long-
term
Benefits
   

 

    Share-based
Payments
     Total  
    Cash
salary
and fees
A$
    Cash
bonus
A$
    Non
Monetary
A$
    Super-
annuation

A$
    Long
service
leave
A$
    Termi-
nation
benefits
A$
    Performance
rights
A$
    Equity-
settled
A$
     A$  

Non-Executive Directors

                  

Ms. L. Turnbull, AO

    137,520        —          —          13,064        —          —          —          —           150,584   

Mr. A .Wong

    84,040        —          —          7,984        —          —          —          —           92,024   

Dr. R. Howard

    90,000        —          —          —          —          —          —          —           90,000   

Mr. P. Meyers 1

    —          —          95,547        —          —          —          —          —           95,547   

Mr. M. Voigt

    347,520        90,616        —          —          —          —          925,347 2       —           1,363,483   

Other Key Management Personnel

                  

Dr. F. Triebel

    229,387        —          —          —          —          —          382,964 2       —           612,351   

Ms. D. Miller

    175,510        50,000        —          21,423        5,817        —          516,332 2       —           769,082   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 
    1,063,977        140,616        95,547        42,471        5,817        —          1,824,643        —           3,173,071   
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

    

 

 

 

 

1 Mr. Pete Meyers was issued 7,720,588 performance rights in lieu of cash for his services as a non-executive director, in accordance with shareholder approval received at the AGM on 14 November 2014. The first tranche of his performance rights vested to him i.e. 1,715,686 converted to ordinary shares immediately after the shareholder approval was received. (Being for service from date of appointment to 30 September 2014). The second tranche of 2,573,529 performance rights vested on 1 October 2015. (Being for service from 1 October 2014 to 30 September 2015); The third tranche of 2,573,529 performance rights is due to vest on 1 October 2016. (Being for service from 1 October 2015 to 30 September 2016); The final 857,844 vest on 1 October 2017. (Being for service from 1 October 2016 to 31 January 2017).

 

2   Performance rights were granted under the EIP. Long term incentive performance rights vest in three tranches as follows:

 

    1/3 vested to Mr Voigt and Ms Miller on 5 August, 2015 and to Dr Triebel on 31 January, 2016.

 

    1/3 vested on 5 August, 2016

 

    1/3 to vest on 5 August, 2017
     Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The performance rights are subject to accelerated vesting according to agreed terms in each person’s employment contract.

 

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Service Agreements

The following members of key personnel have service agreements as follows:

 

Mr. Marc Voigt

   Chief Executive Officer, Chief Business Officer and Chief Financial Officer

Agreement commenced:

   July 9, 2014

Details

  

The initial term is for a period of 3 years. Each party is to provide at least 6 months’ notice of its intention to extend the term of the contract.

 

Prima BioMed may make payments in lieu of the period of notice, or for any unexpired part of that notice period.

 

The agreement can be terminated with 3 months’ notice. The termination terms are payment of base salary in lieu of notice period.

Base salary including superannuation

   €215,000 subject to an increase of €35,000 contingent upon certain performance milestones set forth in the amendment.

Dr. Frédéric Triebel

   Chief Scientific Officer & Chief Medical Officer

Agreement commenced:

   October 01, 2014

Details

  

Each of the parties may terminate the employment contract and the present Amendment, subject to compliance with the law and the CBA and notably to a 3-month notice period as set forth in the CBA.

 

The party which fails to comply with the notice period provisions shall be liable to pay the other an indemnity equal to the salary for the remainder of the notice period.

 

Dr Triebel is subject to a non-competition clause which shall apply for 12 months, starting on the last effective day of work, and covers the territory of European Union. A non-competition indemnity of 33% of the average monthly gross basic remuneration paid to Dr Triebel within 12 months preceding the notification of the termination will be paid on a monthly basis to the Employee during the entirety of the non-competition period, unless the Company releases Dr Triebel from such non-competition clause, in which case the payment period will be 3 months.

Base salary including superannuation

   €170,000

Ms. Deanne Miller

   General Counsel & Company Secretary

Agreement commenced:

   October 13, 2012

Details

  

The agreement can be terminated with 3 months’ notice.

 

The termination terms are payment of base salary in lieu of notice period.

Base salary including superannuation

   A$219,000

Global Employee Share Option Plan

Any person considered to be a full time employee by our Board of Directors is eligible to participate in our Global Employee Share Option Plan, or GESOP, each an Eligible Employee. Under the GESOP, the Board of Directors may issue options to subscribe for our ordinary shares, or GESOP Options, on such terms as it determines.

The maximum number of options available to be issued under the GESOP is 20,000,000. Subject to certain exceptions, the total number of ordinary shares issued as a result of exercise of GESOP Options must not exceed 5% of our issued share capital. The vesting date of a GESOP Option must not be a date less than 12 months following the issue date, or such other period as may be determined by the Board of Directors in its discretion. Any vesting conditions determined by the Board of Directors must be satisfied before the options vest and become exercisable. Options are generally granted for no consideration. When exercisable, each option issued under the GESOP entitles the holder to subscribe for one fully paid ordinary share in us. GESOP Options will expire three years after their issue date. Each ordinary share issued on exercise of an option will rank equally with all other ordinary shares then on issue.

 

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The exercise price of each GESOP Option must be not less than 150% of the price equal to the volume weighted average price of Shares traded on ASX during the 7 trading days immediately prior to the date of grant of the option.

GESOP Options will immediately lapse on the first to occur of:

 

    the last day of the relevant exercise period;

 

    a determination by the Board of Directors that the option should lapse because the option holder:

 

    has been dismissed or removed from office for a reason which entitled us to dismiss the option holder without notice;

 

    has committed an act of fraud, dishonesty or gross misconduct in relation to our affairs;

 

    has done an act with brings us into disrepute; or

 

    has ceased to be employed by us prior to the option being exercisable, other than because of the termination or cessation of the option holder’s employment with us as a result of total and permanent disablement, death or retirement after 55 years of age.

GESOP Options will not confer a right to notices of general meetings (except as may be required by law) or a right to attend, speak or vote at general meeting. A holder of GESOP options may only participate in new issues of securities in respect of GESOP options which have been exercised and ordinary shares issued prior to the record date for the entitlements to the new issue.

In the event that, prior to the vesting of any GESOP Options, there is a reorganization (including a consolidation, subdivision, reduction or return) of our issued capital, then the number of GESOP Options and shares to which each Eligible Employee is entitled on exercise will be reorganized in the manner permitted by the ASX Listing Rules.

If a person acquires a relevant interest in more than 50% of our issued capital or the Board of Directors determines that a person who previously had not been in a position to do so, is in the position, either alone or with associates, to remove more than 50% of the Board of Directors, before the vesting date of a GESOP Option, the GESOP Option becomes exercisable irrespective of the vesting date and vesting conditions attaching to the GESOP Option.

Each GESOP Option is personal to the Eligible Employee and is not transferable, transmissible or assignable, except with the prior written consent of the Board of Directors.

The Board will be able to amend the GESOP rules subject to the requirements of the ASX Listing Rules. The GESOP is administered by the Board of Directors.

 

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Set out below are summaries of options granted under the GESOP up to June 30, 2016.

 

Grant Date

  Expiry Date   

Exercise Price

  Balance
at
Start of
the
Period
    Issued
During
the
Period
    Exercised
During
the
Period
    Lapsed
During
the
Period
    Balance at
End of
the
Period
 

August 26, 2011

  December 6, 2014    lower of A$0.10 or the price equal to the volume weighted average price of Shares traded on ASX during the 30 trading days immediately prior to the date of grant of the ESOP Options.     —         —         —         —         —    

November 3, 2011

  November 3, 2014    the price equal to the volume weighted average price of Shares traded on ASX during the 7 trading days immediately prior to the date of grant of the GESOP Options.     —         —         —         —         —    

January 3, 2012

  January 3, 2015    the price equal to the volume weighted average price of Shares traded on ASX during the 7 trading days immediately prior to the date of grant of the GESOP Options.     —         —         —         —         —     

August 1, 2012

  August 1, 2015    the price equal to the volume weighted average price of Shares traded on ASX during the 7 trading days immediately prior to the date of grant of the GESOP Options.     1,600,000        —         —         (1,600,000     —    

November 16, 2012

  August 1, 2015    the price equal to the volume weighted average price of Shares traded on ASX during the 7 trading days immediately prior to the date of grant of the GESOP Options.     1,200,000        —         —         (1,200,000     —    

February 20, 2013

  February 20, 2015    the price equal to the volume weighted average price of Shares traded on ASX during the 7 trading days immediately prior to the date of grant of the GESOP Options.     200,000        —         —         (200,000     —    

Executive Incentive Plan

A new Executive Incentive Plan, or EIP, was approved by shareholders at the Annual General Meeting in November 2012.The key terms of the EIP are as follows:

Operation

The Board is responsible for administering the EIP in accordance with the EIP Rules. A grant of performance rights and/or options under the EIP will be subject to both the EIP Rules and the terms and conditions of the specific grant.

Eligibility

The EIP is open to employees (including Directors employed in an executive capacity) of the Company who are invited by the Board to participate in the EIP. The EIP is not open to non-executive directors of the Company. All non-executive directors are ineligible to participate in any current employee incentive scheme of the Company. The Board may invite employees to apply for performance rights and/or options under the EIP in its absolute discretion.

Grant

No payment is required on the grant of a performance right and no exercise price is payable upon the performance right vesting. No payment is required on the grant of an option. The exercise price of an option will be determined by the Board in its discretion and specified in the participant’s invitation letter.

 

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Vesting

The vesting of a performance right will be conditional on the satisfaction of any performance conditions attaching to the performance right. Performance conditions will be determined by the Board in its discretion and specified in the participant’s invitation letter. Where relevant performance conditions are met, then the performance right will vest and be automatically be exercised into Shares. The vesting of an option will be conditional on the satisfaction of any performance conditions attaching to the option. Performance conditions will be determined by the Board in its discretion and specified in the participant’s invitation letter.

Where a participant ceases to be an employee of the Company because of total and permanent disability, death, or any other circumstance determined by the Board in its discretion, the Board may determine that any of the performance rights and/or options granted to a participant will vest, whether or not any performance conditions attaching to the performance right and/or option have been met. Notwithstanding this and subject to the ASX Listing Rules:

(i) the Board may vest some or all of a participant’s performance rights and/or options even if a performance condition has not been met, if the Board considers that to do so would be in the interests of the Company; and

(ii) the vesting of a participant’s performance rights and/or options may be made subject to further conditions as determined by the Board.

Lapse of Performance Rights and Options

All performance rights and options that have not vested on or before the fifth anniversary of their grant date will automatically lapse. Performance rights and options will also lapse if the applicable performance conditions attaching to them are not met within a prescribed period determined by the Board in its discretion. If a participant ceases to be an employee of the Company (other than in the circumstances referred to in paragraph (d) above), the participant’s performance rights and/or options will lapse automatically on cessation of the participant’s employment unless the Board determines otherwise within 60 days of the date of cessation of the participant’s employment.

Conversion

A participant may at any time request the Board to convert any or all of the participant’s unvested performance rights to Options, or vice versa, at a rate of conversion determined by the Board in its absolute discretion. Any converted performance rights or Options will be subject to the same terms and conditions of the original performance rights or options (as applicable) granted to the participant unless otherwise determined by the Board in its discretion.

Dealing with Performance Rights and Options

Performance rights and Options are not transferable, except on the participant’s death, to their legal personal representative.

Shares

Each performance right will entitle a participant to one share upon vesting. Each option will entitle a participant upon vesting to subscribe for one share at the exercise price specified by the Board in the participant’s invitation letter. Shares issued as a result of the vesting of a performance right or vesting and exercise of an option will rank equally with the shares currently on issue.

Maximum Number of Performance Rights and Options

The Board may grant such number of performance rights and/or options under the EIP as the Board determines so long as no limit specified, imposed or calculated by any relevant policy or guideline of ASIC, including any regulatory guide, class order or condition for relief, is exceeded.

Takeovers

If the event of a takeover bid (as defined in the Corporations Act), a participant’s performance rights and options will vest immediately to the extent that the performance conditions attaching to those performance rights and/or options have been satisfied and the remaining performance rights and/or options will lapse.

Reconstruction of Capital

If the Company makes a bonus issue, then a participant will become entitled to a proportionately greater number of shares on vesting of the performance rights and/or options held, as if the performance rights and/or options had vested before the bonus issue. If there is any other form of capital reconstruction, the number of performance rights and/or options will be adjusted in accordance with the ASX Listing Rules. A participant is not entitled to participate in any new issue of securities in the Company other than as described above.

 

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Amendment of Incentive Plan

Subject to the ASX Listing Rules, the Board may amend the rules of the EIP, but no amendment may materially reduce the rights of participants generally in respect of the performance rights and/or options granted to them, except an amendment made primarily to enable compliance with the law governing or regulating the EIP, to correct a manifest error or mistake, to take into account changes in development in taxation law or to enable compliance with the Corporations Act or the ASX Listing Rules.

Number of securities issued under the EIP since the date of last approval

Set out below are summaries of options granted under the EIP up to June 30, 2016.

 

Grant Date

   Expiry Date   

Exercise Price

   Balance
at
Start of
the
Period
     Issued
During
the
Period
    Exercised
During
the
Period
    Lapsed
During
the
Period
    Balance at
End of
the
Period
 

December 23, 2013

   June 30, 2018    The Options are exercisable at an exercise price of A$ 0.0774 per Share at any time after vesting and prior to 5pm on June 30, 2018 (Expiry Date).      1,515,752         —         —         —         1,515,752  

January 24, 2014

   June 30, 2018    The Options are exercisable at an exercise price of A$ 0.0774 per Share at any time after vesting and prior to 5pm on June 30, 2018 (Expiry Date).      165,116         —         —         —         165,116   

Set out below are summaries of STI and LTI performance rights granted under the EIP up to June 30, 2016.

 

2016

Grant date

   Fair
value
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Lapsed during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

September 19, 2014

     0.042         7,398,896         —           5,390,073         2,008,823         —           —     

September 19, 2014

     0.044         10,845,588         —           —           5,422,794         5,422,794         —     

September 19, 2014

     0.044         3,615,196         —           —           1,807,598         1,807,598         —     

November 14, 2014

     0.037         4,068,627         —           4,068,627         —           —           —     

November 14, 2014

     0.038         9,191,177         —           —           —           9,191,177         —     

November 14, 2014

     0.040         3,063,725         —           —           —           3,063,725         —     

August 5, 2015

     0.047         —           945,180         945,180         —           —           —     

August 5, 2015

     0.050         —           2,551,985         —           2,551,985         —           —     

August 5, 2015

     0.051         —           850,662         —           850,662         —           —     

August 5, 2015

     0.047         —           42,000,000         13,999,999         —           28,000,001         —     

October 1, 2015

     0.060         —           600,000         —           —           600,000         —     

October 1, 2015

     0.061         —           200,000         —           —           200,000         —     

December 29, 2015

     0.050         —           1,538,462         —           —           1,538,462         —     

March 7, 2016

     0.041         —           1,486,326         —           —           1,486,326         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

        38,183,209         50,172,615         24,403,879         12,641,862        51,310,083         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

C. Board Practices

Introduction

Our Board of Directors is elected by and accountable to our shareholders. It currently consists of five directors, including four non-executive directors, of which one is the non-executive Chairman of our Board of Directors. 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 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.

 

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Corporate Governance

ASX Corporate Governance Principles

In Australia there are no defined corporate governance structures and practices that must be observed by a company listed on the ASX, except that entities of a certain size are required to have audit and remuneration committees and in some instances trading policies for key management personnel. Instead, the ASX Corporate Governance Council has published the Corporate Governance Principles and Recommendations, which contains what are called the Recommendations which articulate eight core principles which are intended to provide a reference point for companies about their corporate governance structures and practices. Under ASX listing Rule 4.10.3, companies are required to attach a copy (or the URL page on its website) of the Company’s corporate governance statement (which has been approved by the Board) and provide a statement in their Annual Report to shareholders disclosing the extent to which they have followed the Recommendations in the reporting period and where they have not followed all the Recommendations, identify the Recommendations that have not been followed, and the reasons for not following them and what (if any) alternative governance practices it adopted in lieu of the recommendations during that period . It is not mandatory to follow the Recommendations. We believe we are in material compliance with the Recommendations. Set forth below are the material provisions of the Recommendations together with the reasons, where applicable, for variations therefrom.

 

1. Lay solid foundations for management and oversight. Companies should establish and disclose the respective roles and responsibilities of board and management and how their performance is monitored and evaluated. During the year ended June 30, 2016, we varied from the Recommendations in the following area:

 

    At present the Board does not have a formal diversity policy as recommended by the ASX Corporate Governance Council’s Principles and Recommendations. The Board believes that the Company does not have a workforce size which is significant enough to require a formal diversity policy. A diversity policy will be formalised as the Company develops and grows. At present the Board ensures that appropriate procedures and measures are introduced and responsibilities delegated to the Remuneration committee to ensure that the both the Board’s and the Company’s diversity objectives are met.

 

2. Structure the Board to add value. Companies should have a board of an effective composition, size, and commitment to adequately discharge its responsibilities and duties effectively. During the year ended June 30, 2016, we varied from the Recommendations in the following area:

 

    The Board believes that we are not of a size, nor are our financial affairs of such complexity, to justify the establishment of a Nomination Committee of the Board of Directors. All matters which might be properly dealt with by a Nomination Committee are considered by the full Board of Directors. The Board considers the necessity to establish a Nomination Committee annually.

 

3. Promote ethical and responsible decision-making . Companies should act ethically and responsibly.

 

4. Safeguard integrity in corporate reporting. Companies should have formal and rigorous processes to independently verify and safeguard the integrity of their corporate reporting.

 

5. Make timely and balanced disclosure. Companies should make timely and balanced disclosure of all matters concerning it that a reasonable person would expect to have a material effect on the price or value of its securities.

 

6. Respect the rights of shareholders. Companies should respect the rights of shareholders by providing them with appropriate information and facilities to allow them the effective exercise of those rights.

 

7. Recognize and manage risk. Companies should establish a sound system of risk management and periodically review the effectiveness of that internal control.

 

8. Remunerate fairly and responsibly. Companies should ensure that the level and composition of remuneration is sufficient and reasonable and that its relationship to performance is clear.

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 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 has five directors, of which four are non-executive directors within the meaning of the Corporate Governance Principles and Recommendations, and our audit committee consists of three such non-executive directors. Accordingly, we currently comply with the Recommendations.

 

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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.

Our Board of Directors has determined that each of Lucy Turnbull, Albert Wong, Pete Meyers, and Russell Howard 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, the performance of our internal audit function 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 Albert Wong, Lucy Turnbull and Pete Meyers. The audit committee meets at least two times per year.

Remuneration Committee. Our Board of Directors has established a Remuneration Committee, which is comprised solely 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. Lucy Turnbull, Russell Howard and Albert Wong are the current members of the Remuneration Committee, each of whom qualifies as an “independent director” within the meaning of NASDAQ Marketplace Rules.

Nominations Committee. Our Board of Directors has not established a Nominations Committee. The Recommendations provide that the Nominations Committee of a company should have a charter that clearly sets out its roles and responsibilities, composition, structure, membership requirements and the procedures for inviting non-committee members to attend meetings. We have not established a Nominations Committee as we do not believe the size of our financial affairs justify the establishment of a separate committee at this time.

Corporate Governance Requirements Arising from Our U.S. Listing — the Sarbanes-Oxley Act of 2002, SEC Rules and the Nasdaq Global Market Marketplace Rules.

Our shares in the form of ADRs are quoted on the Nasdaq Global Market. The Sarbanes-Oxley Act of 2002, as well as related new rules subsequently implemented by the SEC, require companies which are considered to be foreign private issuers in the U.S., such as us, to comply with various corporate governance practices. In addition, Nasdaq has made certain changes to its corporate governance requirements for companies that are listed on the Nasdaq Global Market. These changes allow us to follow Australian “home country” corporate governance practices in lieu of the otherwise applicable Nasdaq corporate governance standards, as long as we disclose each requirement of Rule 5600 that we do not follow and describe the home country practice we follow in lieu of the relevant Nasdaq corporate governance standards. We intend to take all actions necessary to maintain compliance with applicable corporate governance requirements of the Sarbanes-Oxley Act of 2002, rules adopted by the SEC and listing standards of Nasdaq. We follow Australian corporate governance practices in lieu of the corporate governance requirements of the Nasdaq Marketplace Rules in respect of:

 

    Nasdaq requirement under Rule 5620(c) that a quorum consist of holders of 33 1/3% of the outstanding ordinary shares — The ASX Listing Rules do not have an express requirement that each issuer listed on ASX have a quorum of any particular number of the outstanding ordinary shares, but instead allow a listed issuer to establish its own quorum requirements. Our quorum is currently two persons who are entitled to vote. We believe this quorum requirement is consistent with the requirements of the ASX and is appropriate and typical of generally accepted business practices in Australia.

 

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    The Nasdaq requirements under Rules 5605(b)(1) and (2) relating to director independence, including the requirements that a majority of the board of directors must be comprised of independent directors and that independent directors must have regularly scheduled meetings at which only independent directors are present — The Nasdaq and ASX definitions of what constitute an independent director are not identical and the requirements relating to the roles and obligations of independent directors are not identical. The ASX, unlike Nasdaq, permits an issuer to establish its own materiality threshold for determining whether a transaction between a director and an issuer affects the director’s status as independent and it does not require that a majority of the issuer’s board of directors be independent, as long as the issuer publicly discloses this fact. In addition, the ASX does not require that the independent directors have regularly scheduled meeting at which only independent directors are present. We believe that our Board composition is consistent with the requirements of the ASX and that it is appropriate and typical of generally accepted business practices in Australia.

 

    The Nasdaq requirements under Rule 5605(c)(1) and (2) relating to the composition of the audit committee and the audit committee charter — The Nasdaq and ASX audit committee requirements are not identical. Moreover, differences in the requirements of Nasdaq and ASX also arise because of the differences in the definitions of who constitutes an independent director, as discussed above. We have an audit committee and audit committee charter that are consistent with the requirements of the ASX Listing Rules and which we believe are appropriate and typical of generally accepted business practices in Australia.

 

    The Nasdaq requirements under Rules 5605(d) that compensation of an issuer’s officers must be determined, or recommended to the Board for determination, either by a majority of the independent directors, or a compensation committee comprised solely of independent directors, and that director nominees must either be selected, or recommended for the Board’s selection, either by a majority of the independent directors, or a nominations committee comprised solely of independent directors. The Nasdaq compensation committee requirements are not identical to the ASX remuneration and nomination committee requirements. Issuers listed on the ASX are recommended under applicable listing standards to establish a remuneration committee consisting of a majority of independent directors and an independent chairperson, or publicly disclose that it has not done so. We have a Remuneration Committee that is consistent with the requirements of the ASX and which we believe is appropriate and typical of generally accepted business practices in Australia.

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.

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 Prima BioMed, 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, 2016, we had 22 employees. Of such employees, 13 were employed in research and development, one in intellectual property management and 8 in general management and administration. Of these 22 employees, 5 were located in Australia, 5 were located in France and 12 were located in Germany. As at the end of fiscal years 2014 and 2015 we had 31 and 21 employees, respectively. The consolidation of our CVac program and the prioritization of IMP321 led to a change in staff structure, which resulted in a reduction of employees during fiscal year 2015 by approximately 30%.

 

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Each of our full-time employees has entered into an agreement with a term of employment of between one to four years or for an unlimited term. We also engage part-time employees. We may only terminate the employment of any of our employees in accordance with the relevant employee’s contract of employment.

Our standard contract of employment for full time and part-time employees provides that we can terminate the employment of an employee without notice for serious misconduct or with between one to three months’ notice without cause (as set out in the relevant employee’s contract of employment). We can terminate the employment of a casual employee without notice. For a summary of the key terms of employment of each of our senior management, see “Item 6. Directors, Senior Management and Employees—B. Compensation—Service Agreements.”

E. Share Ownership

For a description of arrangements involving the employees in the capital of the company, including any arrangement that involves the issue or grant of options or shares or securities of the company, see “Item 6. Directors, Senior Management and Employees—B. Compensation—Global Employee Share Option Plan,” “—Employee Share Option Plan” and “—Executive Incentive Plan.”

Beneficial Ownership of Senior Management and Directors

Beneficial ownership is determined in accordance with the rules of the U.S. Securities and Exchange Commission, and generally includes voting or investment power with respect to securities. Ordinary shares relating to options currently exercisable or exercisable within 60 days of the date of the above table are deemed outstanding for computing the percentage of the person holding such securities but are not deemed outstanding for computing the percentage of any other person. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table below have sole voting and investment power with respect to all shares shown as beneficially owned by them.

The following table sets forth certain information as of June 30, 2016 regarding the beneficial ownership of our ordinary shares by each of our directors and senior management and by all of our directors and senior management as a group. The shares are beneficially owned, held directly or via an entity related to the individual. The percentages shown are based on 2,061,630,944 ordinary shares issued and outstanding as of June 30, 2016.

 

Name

   Number of Ordinary
Shares Beneficially Owned
    Percentage of
Ownership
 

Lucy Turnbull

     20,359,576        *   

Albert Wong

     3,837,500        *   

Russell Howard

     —          —     

Pete Meyers

     4,289,215        *   

Marc Voigt

    

 

11,605,293

150

  

** 

    *   

Deanne Miller

     4,950,980        *   

Frédéric Triebel

     12,644,716        *   

All directors and executive officers as a group (7 persons) – Ordinary shares

    

 

57,687,430

150

  

** 

    2.80

 

* Less than 1%.
** Shares held in the form of American Depositary Receipts (ADRs) listed on the NASDAQ Global Market.

 

ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS

A. Major Shareholders

One shareholder, Ridgeback Capital Investments LP, or Ridgeback, owned more than 5% or more of our ordinary shares as at June 30, 2016. Ridgeback held 112,343,250 ordinary shares, representing 5.45% of the total issued share capital of the Company as at June 30, 2016. The ordinary shares are registered in the name of its custodian HSBC Custody Nominees (Australia) Limited, with Ridgeback being the underlying holder and entitled to be registered as the holder. Each share ranks pari passu with existing ordinary shares and entitles the holder to one vote. The voting rights of Ridgeback are no different than the voting rights of other holders of our ordinary shares. The associates of Ridgeback (Ridgeback Associates) are Ridgeback Capital Management L.P. (which has the power to control the right to vote and the disposal of the securities) and Wayne Holman (as the controlling party of Ridgeback Capital Management L.P.).

 

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As of June 30, 2016, there were 11,756 holders of record of our ordinary shares, of which 7 holders, holding approximately 0.051% of our ordinary shares, had registered addresses in the United States. These numbers are not representative of the number of beneficial holders of our shares nor are they representative of where such beneficial holders reside, as many of these ordinary shares were held of record by brokers or other nominees. The majority of trading by our U.S. investors is done by means of ADSs that are held of record by National Nominees Ltd, which held 31.66% of our ordinary shares as of such date.

To our knowledge, we are not directly or indirectly controlled by another corporation, by any foreign government or by any other natural or legal person severally or jointly. There are no agreements known to us, the operation of which may at a subsequent date result in a change in control of Prima BioMed.

See also the description of Ridgeback’s investment under the heading “Fiscal 2015” in Item 4.A.

B. Related Party Transactions

We operate inter-company loan accounts with our wholly owned subsidiaries. The net amount of such intercompany loans at June 30, 2016 was A$ nil, as all inter-company transactions are eliminated on consolidation.

During fiscal 2016 there were no related party transactions

Ridgeback is a major shareholder of the Company. In connection with the Ridgeback investment described in Item 4.A under the heading “Fiscal 2015,” Ridgeback received a convertible note. The convertible note was subject to shareholder approval, with such approval being obtained on 31 July 2016. See Item 4. “ Information on the Company—A. History and Development of the Company— Fiscal 2015” and Note 15 to the consolidated financial statements.

During fiscal 2014 there were no related party transactions.

C. Interests of Experts and Counsel

Not applicable.

 

ITEM 8. FINANCIAL INFORMATION

A. Consolidated Statements and Other Financial Information

Our audited consolidated financial statements for the fiscal years ending June 30, 2014, 2015 and 2016 are included in Item 18 of this Annual Report on Form 20-F, which is found immediately following the text of this Annual Report on For 20-F The audit report of PricewaterhouseCoopers as of June 30, 2016 and 2015, and for each of the three years in the period ended June 30, 2016, is included therein immediately preceding the financial statements.

Export Sales

The Company had no export sales in its latest financial year ended June 30, 2016 and for financial years ended June 30, 2015 and June 30, 2014 and, as a result, the percentage of export sales for the Company for each of the three years was zero.

Legal Proceedings

We are not involved in any legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings and those involving any third party, which may have, or have had in the recent past, significant effects on our financial position or profitability. The company is not involved in any governmental proceedings pending or known by us to be contemplated.

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. There is no assurance that dividends will ever be paid. See “Special Note Regarding Forward Looking Statements”.

Recent Developments

There have been no recent developments since June 30, 2016.

B. Significant Changes

There have been no significant changes since the date of the annual financial statements included herein.

 

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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 since our initial public offering on July 9, 2001. 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$)     Per ADS (US$)  
     High      Low     High     Low  
     A$      A$     US$     US$  

Fiscal Year Ended June 30,

         

2012

     0.32         0.09        7.65        2.21   

2013

     0.20         0.06        6.96        1.70   

2014

     0.11         0.03        3.43        0.82   

2015

     0.19         0.02        6.48        0.42   

2016

     0.09         0.04        1.80        0.72   

Fiscal Year Ended June 30, 2015:

         

First Quarter

     0.05         0.04        1.29        0.9   

Second Quarter

     0.05         0.03        1.08        0.74   

Third Quarter

     0.04         0.03        1.03        0.62   

Fourth Quarter

     0.19         0.02        6.48        0.42   

Fiscal Year Ended June 30, 2016:

         

First Quarter

     0.09         0.05        1.80        0.93   

Second Quarter

     0.06         0.05        1.54        1.01   

Third Quarter

     0.06         0.04        1.20        0.72   

Fourth Quarter

     0.05         0.04        1.24        0.90   

Month Ended:

         

April 2016

     0.05         0.04        1.24        0.90   

May 2016

     0.05         0.04        1.18        0.94   

June 2016

     0.05         0.04        1.18        0.92   

July 2016

     0.04         0.04        0.99        0.88   

August 2016

     0.04         0.04        0.94        0.80   

September 2016

     0.04         0.04        0.97        0.85   

For a description of the rights of our ADSs, see “Item 12. Description of Securities Other Than Equity Securities—D. American Depositary Shares.”

B. Plan of Distribution

Not applicable.

C. Markets

Our ordinary shares are listed and traded on the Australian Securities Exchange Ltd., or ASX, on the NASDAQ Global Market where our ordinary shares in the form of ADSs are traded on the NASDAQ Global Market.

D. Selling Shareholders

Not applicable.

E. Dilution

Not applicable.

 

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F. Expenses of the Issue

Not applicable.

 

ITEM 10. ADDITIONAL INFORMATION

A. Share Capital

Not applicable.

B. Memorandum and Articles of Association

General

Our constituent document is a Constitution. The Constitution is subject to the terms of the Listing Rules of ASX Limited and the Corporations Act 2001. The Constitution may be amended or repealed and replaced by special resolution of shareholders, which is a resolution of which notice has been given and that has been passed by at least 75% of the votes cast by shareholders entitled to vote on the resolution.

Purposes and Objects

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

The Powers of the Directors

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

Management of Company

The business is managed by the directors who may exercise all the powers of our company that are not by the Corporations Act or by this constitution required to be exercised by shareholders in general meeting subject nevertheless to any provision of this constitution and to the provisions of the Corporations Act.

Members Approval to Significant Changes

The directors must not make a significant change (either directly or indirectly) to the nature and scale of our activities except after having disclosed full details to ASX in accordance with the requirements of the Listing Rules of the ASX and the directors must not sell or otherwise dispose of the main undertaking of our company without the approval of shareholders in general meeting in accordance with the requirements of the Listing Rules.

Rights 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, fully paid and non-assessable. The rights attached to our ordinary shares are as follows:

Dividend Rights. The directors may declare that a dividend be paid to the members according to the shareholders’ pro rata shareholdings and the directors may fix the amount, the time for payment and the method of payment. 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. Holders of ordinary shares have one vote for each ordinary share held on all matters submitted to a vote of shareholders. Such voting rights may be affected by the grant of any special voting rights to the holders of a class of shares with preferential rights that may be authorized in the future.

The quorum required for an ordinary meeting of shareholders consists of at least two 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. The meeting is dissolved if a quorum is not present within 15 minutes from the time appointed for the meeting.

 

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An ordinary resolution, such as a resolution for the declaration of dividends, 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 our Constitution, a special resolution, such as amending our Constitution, approving any change in capitalization, winding-up, authorization of a class of shares with special rights, 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, and voting thereon.

Rights in Our Profits. Our shareholders have the right to share in our profits distributed as a dividend and any other permitted distribution.

Rights in the Event of Liquidation. In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of ordinary shares in proportion to the capital at the commencement of the liquidation paid up or which ought to have been paid up on the shares held by them respectively. This right may be affected by the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential rights, such as the right in winding up to payment in cash of the amount then paid up on the share, and any arrears of dividend in respect of that share, in priority to any other class of shares.

Changing Rights Attached to Shares

According to our Constitution, the rights attached to any class of shares, unless otherwise provided by the terms of the class, may be varied with either the written consent of the holders of not less than 75% of the issued shares of that class or the sanction of a special resolution passed at a separate general meeting of the shares of that class.

Annual and Extraordinary 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 sheet data. Notice of at least 28 days prior to the date of the meeting is required. A general meeting may be convened by any director, or one or more shareholders holding in the aggregate at least 5% of our issued capital. A general meeting must be called not more than 21 days after the request is made. The meeting must be held not later than two months after the request is given.

Limitations on the Rights to Own Securities in Our Company

Subject to certain limitations on the percentage of shares a person may hold in our company, neither our Constitution nor the laws of the Commonwealth of Australia restrict in any way the ownership or voting of shares in our company.

Changes in Our Capital

Pursuant to the Listing Rules, our directors may in their discretion issue securities to persons who are not related parties of our company, without the approval of shareholders, if such issue, when aggregate with securities issued by our company during the previous 12 month period would be an amount that would not exceed 15% of our issued capital at the commencement of the 12 month period. Other allotments of securities require approval by an ordinary resolution of shareholders.

C. Material Contracts

Except as otherwise disclosed in this annual report (including the exhibits hereto), we are currently not, and have not been in the two years preceding publication of this annual report, party to any material contract, other than contracts entered into in the ordinary course of business.

D. 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 non-residents must be reported to the Australian Cash Transaction Reports Agency, which monitors such transaction, and amounts on account of potential Australian tax liabilities may be required to be withheld unless a relevant taxation treaty can be shown to apply.

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.

 

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Under the Takeovers Act, as currently in effect, any foreign person, together with associates, or parties acting in concert, is prohibited from acquiring 15% or more of the shares in any company having total assets of A$252 million or more (or A$1,094 million or more in case of U.S. investors). “Associates” is a broadly defined term under the Takeovers Act 1975 and includes:

 

    spouses, lineal ancestors and descendants, and siblings;

 

    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$252 million or more (or A$1,094 million or more in case of U.S. investors) 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. The same rule applies if the total holdings of all foreign persons and their associates already exceeds 40% and a foreign person (or its associate) acquires any further shares, including in the course of trading in the secondary market of the ADSs. At present, we do not have total assets of A$231 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 would will be mindful of the number of ADS that can be made available, and monitor the 40% aggregate shareholding threshold for foreign persons (together with the associates) to ensure that it will not be exceeded subject to 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, 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 15% of an Australian company or business with assets totaling over A$252 million (or A$1,094 if the investor is a non-government entity from a ‘partner agreement’ country); or (ii) any direct or indirect ownership in Australian residential real estate and certain non-residential real estate.

The percentage of foreign ownership in our company would also be included determining the foreign ownership of any Australian company or business in which it may choose to invest. Since we have no current plans for any such acquisition and do not own any property, 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 property in Australia.

Our Constitution does not contain any additional limitations on a non-resident’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 ADSs.

E. Taxation

The following is a discussion of Australian and United States tax consequences material to our shareholders. To the extent that the discussion is based on tax legislation which has not been subject to judicial or administrative interpretation, the views expressed in the discussion might not be accepted by the tax authorities in question or by court. The discussion is not intended, and should not be construed, as legal or professional tax advice and does not exhaust all possible tax considerations.

Holders of our ADSs should consult their own tax advisors as to the United States, Australian or other tax consequences of the purchase, ownership and disposition of ADSs, including, in particular, the effect of any foreign, state or local taxes.

E.1. AUSTRALIAN TAX CONSEQUENCES

In this section we discuss the material Australian tax considerations that apply to non-Australian tax residents with respect to the acquisition, ownership and disposal of the absolute beneficial ownership of ADSs, which are evidenced by ADSs. This discussion is based upon existing Australian tax law as of the date of this Annual Report, which is subject to change, possibly retrospectively. This discussion does not address all aspects of Australian income tax law which may be important to particular investors in light of their individual investment circumstances, such as ADSs or shares held by investors subject to special tax rules (for example, financial institutions, insurance companies or tax exempt organizations). In addition, this summary does not discuss any foreign or state tax considerations, other than stamp duty. Prospective investors are urged to consult their tax advisors regarding the Australian and foreign income and other tax considerations of the purchase, ownership and disposition of the ADSs or shares.

 

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Nature of ADSs for Australian Taxation Purposes

Holders of our ADSs are treated as the owners of the underlying ordinary shares for Australian income tax and capital gains tax purposes. Therefore, dividends paid on the underlying ordinary shares will be treated for Australian tax purposes as if they were paid directly to the owners of ADSs, and the disposal of ADSs will be treated for Australian tax purposes as the disposal of the underlying ordinary shares. In the following analysis we discuss the application of the Australian income tax and capital gains tax rules to non-Australian resident holders of ADSs.

Taxation of Dividends

Australia operates a dividend imputation system under which dividends may be declared to be “franked” to the extent they are paid out of company profits that have been subject to income tax. Fully franked dividends are not subject to dividend withholding tax. Dividends that are not franked or are partly franked and are paid to non-Australian resident stockholders are subject to dividend withholding tax, but only to the extent the dividends are not franked.

Dividends paid to a non-resident stockholder are subject to withholding tax (a) except to the extent they have been franked and (b) at 30%, unless the stockholder is a resident of a country with which Australia has a double taxation agreement.

In accordance with the provisions of the Double Taxation Convention between Australia and the United States, the maximum rate of Australian tax on any unfranked portion of a dividend to which a resident of the United States is beneficially entitled is 15%, where the U.S. resident holds less than 10% of the voting rights in our company, or 5% where the U.S. resident holds 10% or more of the voting rights in our company. Special rules apply to Regulated Investment Companies and Real Estate Investment Trusts that hold shares and receive dividends. The Double Taxation Convention between Australia and the United States does not apply to limit the tax rate on dividends where the ADSs are effectively connected to a permanent establishment or a fixed base carried on by the owner of the ADSs in Australia through which the stockholder carries on business or provides independent personal services, respectively.

Tax on Sales or other Dispositions of Shares—Capital Gains Tax

Australian capital gains derived by non-Australian residents in respect of the disposal of capital assets that are not taxable Australian property will be disregarded. Non-Australian resident stockholders will not be subject to Australian capital gains tax on the capital gain made on a disposal of our shares, unless they, together with associates, hold 10% or more of our issued capital, tested either at the time of disposal or over any continuous 12 month period in the 24 months prior to disposal, and the value of our shares at the time of disposal is principally attributable to Australian real property assets.

Australian capital gains tax applies to net capital gains at a taxpayer’s marginal tax rate but for certain stockholders a discount capital gain may apply if the shares have been held for 12 months or more. For individuals, this discount is 50%. Net capital gains are calculated after reduction for capital losses (including certain prior year capital losses), which may only be offset against capital gains.

Tax on Sales or other Dispositions of Shares—Stockholders Holding Shares on Revenue Account

Some non-Australian resident stockholders may hold shares on revenue rather than on capital account, for example, share traders. These stockholders may have the gains made on the sale or other disposal of the shares included in their assessable income under the ordinary income provisions of the income tax law, if the gains are sourced in Australia.

Non-Australian resident stockholders assessable under these ordinary income provisions in respect of gains made on shares held on revenue account would be assessed for such gains at the Australian tax rates for non-Australian residents, which start at a marginal rate of 29% for non-Australian resident individuals. Some relief from the Australian income tax may be available to such non-Australian resident stockholders under the Double Taxation Convention between the United States and Australia, for example, because the stockholder does not have a permanent establishment in Australia.

To the extent an amount would be included in a non-Australian resident stockholder’s assessable income under both the capital gains tax provisions and the ordinary income provisions, the capital gain amount would generally be reduced, so that the stockholder would not be subject to double tax on any part of the income gain or capital gain.

 

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Dual Residency

If a stockholder were a resident of both Australia and the United States under those countries’ domestic taxation laws, that stockholder may be subject to tax as an Australian resident. If, however, the stockholder is determined to be a U.S. resident for the purposes of the Double Taxation Convention between the United States and Australia, the Australian tax applicable would be limited by the Double Taxation Convention. Stockholders should obtain specialist taxation advice in these circumstances.

Stamp Duty

A transfer of shares of a company listed on the Australian Stock Exchange is not subject to Australian stamp duty except in some circumstances where the listed company holds substantial real property and/or real property interests.

Australian Death Duty

Australia does not have estate or death duties. 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.

Research and Development Tax Incentives

The Australian Government tax incentive scheme, introduced on July 1, 2011, replaces the former R&D Tax Concession scheme for research and development activities in income years commencing on or after July 1, 2011. Subject to certain exclusions, the new scheme provides benefits for eligible research and development activities (R&D activities). Such eligible R&D activities include but are not limited to:

 

    Core activities, which are experimental activities whose outcome is not known or cannot be determined in advance, but can only be determined by applying a systematic progression of work;

 

    Core activities must be conducted for the purpose of generating new knowledge (including new knowledge in the form of new or improved processes and materials); or

 

    Supporting activities that are directly related and designed to support core activities and are usually required in order for the core activities to take place.

Under the R&D Tax incentive scheme, entities will be entitled to either (i) a 45% refundable tax offset for eligible companies with an aggregated turnover of less than $20 million per annum; or (ii) a non-refundable 40% tax offset for all other eligible companies. Where our turnover is less than $20 million, we anticipate being entitled to claim a 45% refundable tax offset for costs relating to eligible R&D activities during the year.

E.2 UNITED STATES FEDERAL INCOME TAX CONSEQUENCES

The following is a summary of material U.S. federal income tax consequences that generally apply to U.S. Holders (as defined below) who hold ADSs as capital assets. This summary is based on the United States Internal Revenue Code of 1986, as amended, or the Code, Treasury regulations promulgated thereunder, judicial and administrative interpretations thereof, and the bilateral taxation convention between Australia and the United States, or the Tax Treaty, all as in effect on the date hereof and all of which are subject to change either prospectively or retroactively. If you are a U.S. Holder and subject to special rules, including broker-dealers, financial institutions, certain insurance companies, investors liable for alternative minimum tax, tax-exempt organizations, regulated investment companies, non-resident aliens of the United States or taxpayers whose functional currency is not the U.S. dollar, persons who hold the ADSs through partnerships or other pass-through entities, persons who acquired their ADSs through the exercise or cancellation of any employee stock options or otherwise as compensation for their services, investors that actually or constructively own 10% or more of our voting shares, and investors holding ADSs as part of a straddle or appreciated financial position or as part of a hedging or conversion transaction, you are strongly advised to consult your personal tax advisor. This summary does not address any state, local and foreign tax considerations or any U.S. federal estate, gift or alternative minimum tax considerations relevant to the purchase, ownership and disposition of our ADSs.

If a partnership or an entity treated as a partnership for U.S. federal income tax purposes owns ADSs, the U.S. federal income tax treatment of its partners will generally depend upon the status of the partner and the activities of the partnership. A partnership should consult its tax advisors regarding the U.S. federal income tax consequences applicable to it and its partners of the purchase, ownership and disposition of ADSs.

 

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For purposes of this summary, the term “U.S. Holder” means an individual who is a citizen or, for U.S. federal income tax purposes, a resident of the United States; a corporation or other entity taxable as a corporation that is created or organized in or under the laws of the United States or any political subdivision thereof; an estate whose income is subject to U.S. federal income tax regardless of its source; or a trust if (a) a court within the United States is able to exercise primary supervision over administration of the trust, and one or more U.S. persons have the authority to control all substantial decisions of the trust or (b) it has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.

Distributions

For U.S. federal income tax purposes, a U.S. Holder of ADSs will be treated as owning the underlying ordinary shares, or ADSs. Subject to the passive foreign investment company rules discussed below, the gross amount of any distribution received by a U.S. Holder with respect to the underlying ordinary shares, including the amount of any Australian taxes withheld therefrom, will be included in gross income as a dividend to the extent the distribution is paid out of our current or accumulated earnings and profits (as determined under U.S. federal income tax principles). Distributions in excess of our earnings and profits will be treated first as a non-taxable return of capital to the extent of a U.S. Holder’s tax basis in the ADSs and thereafter will be treated as gain from the sale or exchange of the ADSs. We have not maintained and do not plan to maintain calculations of earnings and profits for U.S. federal income tax purposes. As a result, a U.S. Holder may need to include the entire amount of any such distribution in income as a dividend.

The U.S. dollar value of any distribution on the ADSs made in Australian dollars generally should be calculated by reference to the exchange rate between the U.S. dollar and the Australian dollar in effect on the date of receipt of such distribution by the U.S. Holder regardless of whether the Australian dollars so received are in fact converted into U.S. dollars. A U.S. Holder who receives payment in Australian dollars and converts those Australian dollars into U.S. dollars at an exchange rate other than the rate in effect on such day may have a foreign currency exchange gain or loss, which would generally be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.

Subject to complex limitations and certain holding period requirements, a U.S. Holder may elect to claim a credit for Australian tax withheld from distributions against its U.S. federal income tax liability. The limitations set out in the Code include computational rules under which foreign tax credits allowable with respect to specific classes of income cannot exceed the U.S. federal income taxes otherwise payable with respect to each such class of income. Dividends generally will be treated as foreign-source passive category income for U.S. foreign tax credit purposes. A U.S. Holder that does not elect to claim a U.S. foreign tax credit may instead claim a deduction for Australian tax withheld. Dividends will not however be eligible for the “dividends received deduction” generally allowed to corporate shareholders with respect to dividends received from U.S. corporations.

Subject to certain limitations, dividends received by a non-corporate U.S. Holder are subject to tax at a reduced maximum tax rate of 20 percent. Distributions taxable as dividends generally qualify for the 20 percent rate provided that: (i) the issuer is entitled to benefits under the Tax Treaty or (ii) the shares are readily tradable on an established securities market in the United States and certain other requirements are met. We believe that we are entitled to benefits under the Tax Treaty and that the ADSs currently are readily tradable on an established securities market in the United States. However, no assurance can be given that the ADSs will remain readily tradable. However, the reduced rate does not apply to dividends received from PFICs. As noted below, we believe there is a material risk that we are a PFIC.

The U.S. Treasury has expressed concerns that intermediaries in the chain of ownership between the holder of an ADS and the issuer of the security underlying the ADS may be taking actions (including pre-release transactions that may be undertaken by the depositary as described in “Description of American Depositary Shares – Pre-release of ADSs”) that are inconsistent with the claiming of foreign tax credits for U.S. holders of ADSs. Such actions would also be inconsistent with the claiming of the reduced rated of tax, described below, applicable to dividends received by certain non-corporate holders. Accordingly, the analysis of the creditability of Australian taxes and the availability of the reduced tax rate for dividends received by certain non-corporate holders, each described below, could be affected by actions taken by intermediaries in the chain of ownership between the holder of an ADS and our Company.

Disposition of ADSs

If you sell or otherwise dispose of ADSs, you will recognize gain or loss for U.S. federal income tax purposes in an amount equal to the difference between the amount realized on the sale or other disposition and your adjusted tax basis in the ADSs. Subject to the passive foreign investment company rules discussed below, such gain or loss generally will be capital gain or loss and will be long-term capital gain or loss if you have held the ADSs for more than one year at the time of the sale or other disposition. In general, any gain that you recognize on the sale or other disposition of ADSs will be gain from U.S. sources for purposes of the foreign tax credit limitation; losses will generally be allocated against U.S. source income. The deduction of capital losses is subject to certain limitations under the Code.

 

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In the case of a cash basis U.S. Holder who receives Australian dollars in connection with the sale or other disposition of ADSs, the amount realized will be calculated based on the U.S. dollar value of the Australian dollars received as determined on the settlement date of such exchange. A U.S. Holder who receives payment in Australian dollars and converts Australian dollars into U.S. dollars at a conversion rate other than the rate in effect on the settlement date may have a foreign currency exchange gain or loss that would be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.

An accrual basis U.S. Holder may elect the same treatment required of cash basis taxpayers with respect to a sale or disposition of ADSs, provided that the election is applied consistently from year to year. Such election may not be changed without the consent of the Internal Revenue Service, or the IRS. In the event that an accrual basis U.S. Holder does not elect to be treated as a cash basis taxpayer (pursuant to the Treasury regulations applicable to foreign currency transactions), such U.S. Holder may have a foreign currency gain or loss for U.S. federal income tax purposes because of differences between the U.S. dollar value of the currency received prevailing on the trade date and the settlement date. Any such currency gain or loss would be treated as ordinary income or loss from sources within the United States for U.S. foreign tax credit purposes.

Passive Foreign Investment Companies

There is a substantial risk that we are a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. Our treatment as a PFIC could result in a reduction in the after-tax return to the U.S. Holders of our ADSs and may cause a reduction in the value of such securities.

For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset which produces passive income. Passive income generally includes dividends, interest, royalties, rents, annuities and the excess of gains over losses from the disposition of assets which produce passive income. As a result of our substantial cash position, the decline in the value of our stock and the current composition of our gross income, we believe that there is a material risk that we are currently a PFIC and that may be a PFIC in the future.

If we are a PFIC in any taxable year during which a U.S. Holder owns ADSs, such U.S. Holder could be liable for additional taxes and interest charges upon (i) certain distributions by us (generally any distribution paid during a taxable year that is greater than 125 percent of the average annual distributions paid in the three preceding taxable years, or, if shorter, the U.S. Holder’s holding period for the ADSs), and (ii) any gain realized on a sale, exchange or other disposition, including a pledge, of the ADSs, whether or not we continue to be a PFIC. In these circumstances, the tax will be determined by allocating such distributions or gain ratably over the U.S. Holder’s holding period for the ADSs. The amount allocated to the current taxable year and any year prior to the first taxable year in which we are a PFIC will be taxed as ordinary income (rather than capital gain) earned in the current taxable year. The amount allocated to other taxable years will be taxed at the highest marginal rates applicable to ordinary income for each such taxable year, and an interest charge, generally that applicable to underpayments of tax, will also be imposed on the amount of taxes so derived for each such taxable year.

The PFIC provisions discussed above apply to U.S. persons who directly or indirectly hold stock in a PFIC. Both direct and indirect shareholders of PFICs are subject to the rules described above. Generally, a U.S. person is considered an indirect shareholder of a PFIC if it is:

 

    A direct or indirect owner of a pass-through entity, including a trust or estate, that is a direct or indirect shareholder of a PFIC;

 

    A shareholder of a PFIC that is a shareholder of another PFIC; or

 

    A 50%-or-more shareholder of a foreign corporation that is not a PFIC and that directly or indirectly owns stock of a PFIC.

An indirect shareholder may be taxed on a distribution paid to the direct owner of the PFIC and on a disposition of the stock indirectly owned. Indirect shareholders are strongly urged to consult their tax advisors regarding the application of these rules.

If we cease to be a PFIC in a future year, a U.S. Holder may avoid the continued application of the tax treatment described above by electing to be treated as if it sold its ADSs on the last day of the last taxable year in which we were a PFIC. Any gain would be recognized and subject to tax under the rules described above. Loss would not be recognized. A U.S. Holder’s basis in its ADSs would be increased by the amount of gain, if any, recognized on the sale. A U.S. Holder would be required to treat its holding period for its ADSs as beginning on the day following the last day of the last taxable year in which we were a PFIC.

 

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If the ADSs are considered “marketable stock” and if a U.S. Holder elects to “mark-to-market” its ADSs, the U.S. Holder would not be subject to tax under the excess distribution regime described above. Instead, the U.S. Holder would generally include in income any excess of the fair market value of the ADSs at the close of each tax year over the adjusted tax basis of the ADSs. If the fair market value of the ADSs had depreciated below the adjusted basis at the close of the tax year, the U.S. Holder would be entitled to deduct the excess of the adjusted basis of the ADSs over their fair market value at that time. However, such deductions generally would be limited to the net mark-to-market gains, if any, the U.S. Holder included in income with respect to such ADSs in prior years. Income recognized and deductions allowed under the mark-to-market provisions, as well as any gain or loss on the disposition of ADSs with respect to which the mark-to-market election is made, is treated as ordinary income or loss (except that loss is treated as capital loss to the extent the loss exceeds the net mark-to-market gains, if any, that a U.S. Holder included in income with respect to such ordinary shares in prior years). However, gain or loss from the disposition of ADSs (as to which a “mark-to-market” election was made) in a year in which we are no longer a PFIC, will be capital gain or loss. Our ADSs should be considered “marketable stock” if they traded at least 15 days during each calendar quarter of the relevant calendar year in more than de minimis quantities.

A U.S. Holder of ADSs will not be able to avoid the tax consequences described above by electing to treat us as a qualified electing fund. In general, a qualified electing fund is, with respect to a U.S. person, a passive foreign investment company if the U.S. person has elected to include its proportionate share of a company’s ordinary earnings and net capital gains in U.S. income on an annual basis. A qualified electing fund election can only be made with respect to us if we provide U.S. Holders with certain information on an annual basis and we do not intend to prepare the information that U.S. Holders would need to make the qualified electing fund election.

Backup Withholding and Information Reporting

Payments in respect of ADSs may be subject to information reporting to the U.S. Internal Revenue Service and to U.S. backup withholding tax at a rate equal to the fourth lowest income tax rate applicable to individuals (which, under current law, is 28%). Backup withholding will not apply, however, if a U.S. Holder (i) is a corporation, (ii) satisfies an applicable exemption, or (iii) furnishes correct taxpayer identification.

Backup withholding is not an additional tax. Amounts withheld under the backup withholding rules may be credited against a U.S. Holder’s U.S. tax liability, and a U.S. Holder may obtain a refund of any excess amounts withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS.

F. Dividends and Paying Agents

Not applicable.

G. Statement by Experts

Not applicable.

H. Documents on Display

We are subject to the reporting requirements of the U.S. Securities 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 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 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 which are referred to in this document may also be inspected at our office located at Level 12, 95 Pitt Street, Sydney New South Wales 2000, Australia.

I. Subsidiary Information

We currently have the following subsidiaries:

 

    Prima BioMed USA Inc, a 100% owned subsidiary of Prima BioMed Ltd, incorporated in the United States.

 

    Prima BioMed GmbH, a 100% owned subsidiary of Prima BioMed Ltd, incorporated in Germany.

 

    Prima BioMed Australia Pty Ltd, a 100% owned subsidiary of Prima BioMed Ltd, incorporated in Australia.

 

    Prima BioMed IP Pty Ltd, a 100% owned subsidiary of Prima BioMed Ltd, incorporated in Australia.

 

    Immutep S.A.S., a 100% owned subsidiary of Prima BioMed Ltd, incorporated in France

These subsidiaries were established to allow us to conduct commercial and clinical operations in Europe and the United States. In November 2011, we also formed Prima BioMed Middle East FZ LLC, a 100% owned subsidiary of Prima BioMed Ltd, incorporated in the United Arab Emirates. However, this subsidiary is in the process of being dissolved. See “Item 4. Information on the Company—C. Organizational Structure” for more information.

 

ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Our cash and cash equivalents consist primarily of cash and money market funds. We invest our excess cash and cash equivalents in interest-bearing accounts and term deposits with banks in Australia. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of Australian interest rates. However, because of the short-term nature of the instruments in our portfolio, a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation.

We conduct our activities predominantly in Australia. However, we are exposed to foreign currency risk via trade and other payables we hold. We are required to make certain payments in U.S. dollars, European Euro and other currencies. See “Note 2. Financial Risk Management—(a) Market Risk” to our notes to the financial statements for a further discussion of market risk and sensitivity analysis.

Our exposure to foreign currency risk at the end of the reporting period, expressed in Australian dollar, was as follows:

 

     June 30, 2016      June 30, 2015  
     USD      EUR      USD      EUR  

Cash in bank

     1,428,959         7,261,477         839,185         1,813,642   

Trade and other receivables

     27,205         29,539         126,958         34,592   

Trade and other payables

     (10,993      (256,364      (221,097      (201,561

Borrowings

     —           —           (822,930      (300,000

 

ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

A. Debt Securities

Not applicable.

B. Warrants and Rights

Not applicable.

 

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C. Other Securities

Not applicable.

D. American Depositary Shares

The following are fees and charges that a holder of our ADSs may have to pay to the Bank of New York Mellon, as depositary:

 

Persons depositing or withdrawing ordinary shares or ADS
holders must pay:
   For:

US$5.00 (or less) per 100 ADSs (or portion of 100 ADSs)

  

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

 

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

US$0.05 (or less) per ADS

  

•    Any cash distribution to ADS holders

A fee equivalent to the fee that would be payable if securities distributed to an ADS holder had been ordinary shares and the ordinary shares had been deposited for issuance of ADSs, i.e., US$5.00 or less per 100 ADSs (or portion of 100 ADSs)

  

•    Distribution of securities distributed to holders of deposited securities which are distributed by the depositary to ADS holders

US$.05 (or less) per ADSs per calendar year

  

•    Depositary services

Registration or transfer fees

  

•    Transfer and registration of ordinary shares on our ordinary share register to or from the name of the depositary or its agent when an ADS holder deposits or withdraws ordinary shares

Expenses of the depositary

  

•    Cable, telex 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 have to pay on any ADS or ordinary share underlying an ADS, for example, 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 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.

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

ADS holders are responsible for any taxes or other governmental charges payable on its ADSs or on the deposited securities represented by any of its ADSs. The depositary may refuse to register any transfer ADSs or allow an ADS holder to withdraw the deposited securities represented by its ADSs until such taxes or other charges are paid. It may apply payments owed to an ADS holder or sell deposited securities represented by an ADS holder’s ADSs to pay any taxes owed and such ADS holder 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 the holders of ADSs holder any proceeds, or send to the holders of ADSs any property, remaining after it has paid the taxes.

 

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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

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our chief executive officer and chief financial officer, has performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of June 30, 2016, as required by Rule 13a-15(b) under the Exchange Act. Based on that evaluation, our management has concluded that, as of June 30, 2016, our disclosure controls and procedures were effective.

Management’s Annual Report on Internal Control over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting as of June 30, 2016 based on the criteria set forth in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013). Based on our evaluation under the criteria set forth in Internal Control — Integrated Framework , our management concluded that our internal control over financial reporting was effective as of June 30, 2016.

This Annual Report does not include an attestation report of the Company’s registered public accounting firm as we are an emerging growth company.

Inherent Limitations on Effectiveness of Controls

In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Changes in Internal Control Over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) for the fiscal year ended June 30, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

ITEM 15T. CONTROLS AND PROCEDURES

Not applicable.

 

ITEM 16. RESERVED

Not applicable.

 

ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT

Pete Meyers is a member of our board of directors and serves on our audit committee. Our board has determined that Pete Meyers is an audit committee financial expert and satisfies the “independence” requirements of the U.S. Securities and Exchange Commission, the NASDAQ Marketplace Rules and ASX Rules.

 

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ITEM 16B. CODE OF ETHICS

We have adopted a code of conduct that applies to our chief executive officer and all senior financial officers of our company, including the chief financial officer, chief accounting officer or controller, or persons performing similar functions. The code of conduct is publicly available as attachment C to our Board Charter on our website at www.primabiomed.com.au. Written copies are available upon request. If we make any substantive amendment to the code of conduct or grant any waivers, including any implicit waiver, from a provision of the code of conduct, we will disclose the nature of such amendment or waiver on our website.

 

ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES

We retained PricewaterhouseCoopers as our independent registered public accounting firm. Set forth below is a summary of the fees paid to PricewaterhouseCoopers services provided in fiscal years 2016, 2015 and 2014.

PricewaterhouseCoopers

 

     Fiscal 2016
A$
     Fiscal 2015
A$
 

Audit fees

     441,741         286,000   

Audit-related fees*

     —          66,986  
  

 

 

    

 

 

 

Total

     441,741         352,986   
  

 

 

    

 

 

 

 

  * Related to due diligence services

Pre-Approval Policies and Procedures

Our Audit Committee has adopted policies and procedures for the pre-approval of audit and non-audit services rendered by our independent registered public accounting firm. Pre-approval of an audit or non-audit service may be given as a general pre-approval, as part of the audit committee’s approval of the scope of the engagement of our independent registered public accounting firm, or on an individual basis. Any proposed services exceeding general pre-approved levels also requires specific pre-approval by our audit committee. The policy prohibits retention of the independent registered public accounting firm to perform the prohibited non-audit functions defined in Section 201 of the Sarbanes-Oxley Act or the rules of the Securities and Exchange Commission, and also requires the audit committee to consider whether proposed services are compatible with the independence of the registered public accounting firm.

 

ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES

Not applicable.

 

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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

Under NASDAQ Stock Market Rule 5615(a)(3), foreign private issuers, such as our company, are permitted to follow certain home country corporate governance practices instead of certain provisions of the NASDAQ Stock Market Rules. A foreign private issuer that elects to follow a home country practice instead of any such NASDAQ rules must submit to NASDAQ, in advance, a written statement from an independent counsel in such issuer’s home country certifying that the issuer’s practices are not prohibited by the home country’s laws. We submitted such a written statement to NASDAQ. See “Item 6. Directors, Senior Management and Employees—C. Board Practices—Corporate Governance Requirements Arising from our U.S. Listing—the Sarbanes-Oxley Act of 2002, SEC Rules and the Nasdaq Global Market Marketplace Rules” for a summary of such differences.

 

ITEM 16H. MINE SAFETY DISCLOSURE

Not applicable.

PART III

 

ITEM 17. FINANCIAL STATEMENTS

We have elected to furnish financial statements and related information specified in Item 18.

 

ITEM 18. FINANCIAL STATEMENTS

 

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Prima BioMed Ltd

Index to Consolidated Financial Statements

 

     Page  

Report of Independent Registered Public Accounting Firm

     F-2   

Consolidated Balance Sheets as of June 30, 2016 and 2015

     F-3   

Consolidated Statements of Comprehensive Loss for the years ended June  30, 2016, 2015, and 2014

     F-4   

Consolidated Cash Flow Statements for the years ended June  30, 2016, 2015, and 2014

     F-5   

Consolidated Statements of Changes in Equity for the years ended June  30, 2016, 2015, and 2014

     F-6   

Notes to the Consolidated Financial Statements

     F-7   

 

F-1


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LOGO    Report of Independent Registered Public Accounting Firm   

To Board of Directors and Shareholders of Prima BioMed Ltd:

In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of comprehensive loss, of cash flows and of changes in equity present fairly, in all material respects, the financial position of Prima BioMed Ltd and its subsidiaries at June 30, 2016 and 2015, and the results of their operations and their cash flows for each of the three years in the period ended June 30, 2016 in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with the standards of the Public Company Accounting Oversight Board (United States) and International Standards on Auditing. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

/s/ PricewaterhouseCoopers

PricewaterhouseCoopers

Sydney, Australia

October 3, 2016

 

 

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PRIMA BIOMED LTD

CONSOLIDATED BALANCE SHEETS

(in Australian dollars, except number of shares)

 

            June 30,  
     Note      2016
A$
    2015
A$
 

ASSETS

       

Current Assets

       

Cash and cash equivalents

     7         20,879,548        6,759,615   

Current receivables

     8         168,300        315,453   

Other current assets

     9         623,020        948,003   
     

 

 

   

 

 

 

Total Current Assets

        21,670,868        8,023,071   
     

 

 

   

 

 

 

Non-Current Assets

       

Plant and equipment

     10         31,500        297,957   

Intangibles

     11         20,851,699        22,662,417   
     

 

 

   

 

 

 

Total Non-Current Assets

        20,883,199        22,960,374   
     

 

 

   

 

 

 

TOTAL ASSETS

        42,554,067        30,983,445   

Current Liabilities

       

Trade and other payables

     13         1,422,798        2,770,049   

Borrowings

     14         —          1,508,473   

Current tax payable

        21,549        20,837   

Employee benefits

     16         27,694        80,304   
     

 

 

   

 

 

 

Total Current Liabilities

        1,472,041        4,379,663   
     

 

 

   

 

 

 

Non-Current Liabilities

       

Convertible note liability

     15         5,027,168        —     

Employee benefits

     17         43,151        35,706   

Deferred tax liability

     12         694,194        1,878,333   
     

 

 

   

 

 

 

Total Non-Current Liabilities

        5,764,513        1,914,039   
     

 

 

   

 

 

 

TOTAL LIABILITIES

        7,236,554        6,293,702   
     

 

 

   

 

 

 

NET ASSETS

        35,317,513        24,689,743   
     

 

 

   

 

 

 

EQUITY

       

Contributed equity

     18         194,530,932        179,878,436   

Reserves

     19         63,258,187        5,267,729   

Accumulated losses

        (222,471,606     (160,456,422
     

 

 

   

 

 

 

Equity attributable to the owners of Prima BioMed Ltd

        35,317,513        24,689,743   
     

 

 

   

 

 

 

TOTAL EQUITY

        35,317,513        24,689,743   
     

 

 

   

 

 

 

The above consolidated balance sheets should be read in conjunction with the accompanying notes

 

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PRIMA BIOMED LTD

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in Australian dollars, except number of shares)

 

            Years ended June 30,  
     Note      2016
A$
    2015
A$
    2014
A$
 

Revenue

         

License revenue.

        175,052        —          —     

Other income

         

Miscellaneous income

        702,743        168,322        15,929   

Grant income

        887,083        1,167,190        2,004,198   

Net gain on foreign exchange

        —          538,248        406,628   

Interest income

        264,043        219,107        713,311   
     

 

 

   

 

 

   

 

 

 

Total revenue and other income

        2,028,921        2,092,867        3,140,066   
     

 

 

   

 

 

   

 

 

 

Expenses

         

Research & development and intellectual property

     5         (7,059,528     (8,952,447     (11,930,857

Corporate administrative expenses

     5         (6,982,629     (5,723,106     (4,092,623

Depreciation and amortization expenses

     5         (1,993,093     (1,341,202     (446,360

Share Based Payment to strategic investor

     15         (47,468,071     —          —     

Loss on foreign exchange

     5         (563,890     —          —     

Net finance cost

     5         (8,199     (18,364,804     —     

Changes in fair value of comparability milestone

     5         (542,075     —          —     

Loss on disposal of assets

     5         —          (5,160     —     

Changes in fair value of convertible note liability

     15         (607,637     —          —     
     

 

 

   

 

 

   

 

 

 

Loss before income tax expense

        (63,196,201     (32,293,852     (13,329,774

Income tax expense

     6         1,181,017        142,156        (13,607
     

 

 

   

 

 

   

 

 

 

Loss after income tax expense for the year

        (62,015,184     (32,151,696     (13,343,381

Other Comprehensive Loss

         

Items that may be reclassified to profit or loss

         

Exchange differences on the translation of foreign operations

        306,997        (56,907     (57,421
     

 

 

   

 

 

   

 

 

 

Other comprehensive loss for the year net of tax

        306,997        (56,907     (57,421
     

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

        (61,708,187     (32,208,603     (13,400,802
     

 

 

   

 

 

   

 

 

 

Loss for the year is attributable to:

         

Owners of Prima BioMed Ltd

        (62,015,184     (32,151,696     (13,343,381
     

 

 

   

 

 

   

 

 

 
        (62,015,184     (32,151,696     (13,343,381
     

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year is attributable to:

         

Owners of Prima BioMed Ltd

        (61,708,187     (32,208,603     (13,400,802
     

 

 

   

 

 

   

 

 

 
        (61,708,187     (32,208,603     (13,400,802
     

 

 

   

 

 

   

 

 

 
        Cents        Cents        Cents   

Basic earnings per share

     30         (2.77     (2.02     (0.93

Diluted earnings per share

     30         (2.77     (2.02     (0.93

The above consolidated statements of comprehensive loss should be read in conjunction with the accompanying notes

 

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PRIMA BIOMED LTD

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in Australian dollars, except number of shares)

 

            Years Ended June 30,  
     Note      2016
A$
    2015
A$
    2014
A$
 

Cash flows related to operating activities

         

Payments to suppliers and employees (inclusive of GST)

        (13,336,202     (15,276,020     (16,928,382

Miscellaneous income

        702,743        168,322        —     

License revenue

        175,052        —          15,929   

License fee received

        —          5,774,784        —     

Interest received

        264,043        380,650        704,778   

Tax paid

        (2,410     (1,908     (23,684

Grant income

        887,083        1,167,190        2,004,198   
     

 

 

   

 

 

   

 

 

 

Net cash flows used in operating activities

        (11,309,691     (7,786,982     (14,227,161
     

 

 

   

 

 

   

 

 

 

Cash flows related to investing activities

         

Payments for held-to-maturity investments

        —          —          (9,000,000

Cash received from held-to-maturity investments

        —          9,000,000        8,000,000   

Proceeds from disposal of plant and equipment

        129,705        —          —     

Payments for plant and equipment

        (27,130     (48,499     (103,675

Payment for acquisition of subsidiary, net of cash acquired

        —          (20,912,912     —     
     

 

 

   

 

 

   

 

 

 

Net cash flows provided by (used in) investing activities

        102,575        (11,961,411     (1,103,675
     

 

 

   

 

 

   

 

 

 

Cash flows related to financing activities

         

Proceeds from issue of shares and options*

        13,761,075        7,744,648        6,845,001   

Proceeds from issue of convertible notes

        13,750,828        —          —     

Proceeds from borrowings

        —          3,925,405        —     

Repayment of borrowings*

        (1,508,473     (237,308     —     

Share issue transaction costs

        (283,146     (164,316     (157,606
     

 

 

   

 

 

   

 

 

 

Net cash flows provided by financing activities

        25,720,284        11,268,429        6,687,395   
     

 

 

   

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

        14,513,168        (8,479,964     (8,643,441

Effect of exchange rate on cash and cash equivalents

        (393,235     1,039,537        820,340   

Cash and cash equivalents at the beginning of the year

        6,759,615        14,200,042        22,023,143   
     

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the year

     7         20,879,548        6,759,615        14,200,042   
     

 

 

   

 

 

   

 

 

 

 

* During the year ended 30 June 2015, convertible notes in the amount of $2,853,883 were converted into equity. No impact has been recorded on the cashflow statement for this conversion.

The above consolidated statements of cash flows should be read in conjunction with the accompanying notes

 

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PRIMA BIOMED LTD

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(in Australian dollars, except number of shares)

 

Consolidated

   Issued Equity
A$
     Reserves
A$
    Retained earnings
A$
    Total equity
A$
 

Balance at July 1, 2013

     142,326,977         1,882,786        (114,961,345     29,248,418   

Other comprehensive loss for the year, net of tax

     —           (57,421     —          (57,421

Loss after income tax expense for the year

     —           —          (13,343,381     (13,343,381
  

 

 

    

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

     —           (57,421     (13,343,381     (13,400,802
  

 

 

    

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

         

Contributions of equity, net of transaction costs

     6,687,395         —          —          6,687,395   

Employee options scheme

     —           57,309        —          57,309   
  

 

 

    

 

 

   

 

 

   

 

 

 

Balance at June 30, 2014

     149,014,372         1,882,674        (128,304,726     22,592,320   
  

 

 

    

 

 

   

 

 

   

 

 

 

Consolidated

   Issued Equity
A$
     Reserves
A$
    Retained earnings
A$
    Total equity
A$
 

Balance at July 1, 2014

     149,014,372         1,882,674        (128,304,726     22,592,320   

Other comprehensive loss for the year, net of tax

     —           (56,907     —          (56,907

Loss after income tax expense for the year

     —           —          (32,151,696     (32,151,696
  

 

 

    

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

     —           (56,907     (32,151,696     (32,208,603
  

 

 

    

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

         

Contributions of equity, net of transaction costs

     30,800,584         2,201,037        —          33,001,621   

Share based payment

     —           565,606        —          565,606   

Employee share based payment

     —           738,799        —          738,799   

Exercise of vested performance rights

     63,480         (63,480     —          —     
  

 

 

    

 

 

   

 

 

   

 

 

 

Balance at June 30, 2015

     179,878,436         5,267,729        (160,456,422     24,689,743   
  

 

 

    

 

 

   

 

 

   

 

 

 

Consolidated

   Issued Equity
A$
     Reserves
A$
    Retained earnings
A$
    Total equity
A$
 

Balance at July 1, 2015

     179,878,436         5,267,729        (160,456,422     24,689,743   

Other comprehensive gain for the year, net of tax

     —           306,997        —          306,997   

Loss after income tax expense for the year

     —           —          (62,015,184     (62,015,184
  

 

 

    

 

 

   

 

 

   

 

 

 

Total comprehensive loss for the year

     —           306,997        (62,015,184     (61,708,187
  

 

 

    

 

 

   

 

 

   

 

 

 

Transactions with owners in their capacity as owners:

         

Contributions of equity, net of transaction costs

     13,477,930         —          —          13,477,930   

Issue of convertible notes

     —           9,331,297        —          9,331,297   

Share based payment

     —           82,242        —          82,242   

Share based payment to strategic investor

     —           47,468,071        —          47,468,071   

Employee share based payment

     —           1,976,417        —          1,974,417   

Exercise of vested performance rights

     1,174,566         (1,174,566     —          —     
  

 

 

    

 

 

   

 

 

   

 

 

 

Balance at June 30, 2016

     194,530,932         63,258,187        (222,471,606     35,317,513   
  

 

 

    

 

 

   

 

 

   

 

 

 

The above consolidated statements of changes in equity should be read in conjunction with the accompanying notes

 

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PRIMA BIOMED LTD

NOTES TO THE FINANCIAL STATEMENTS

(in Australian dollars, unless otherwise noted)

NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The principal accounting policies adopted in the preparation of the financial statements are set out below. These policies have been consistently applied to all years presented, unless otherwise stated. The financial statements are for the consolidated entity consisting of the Company and its subsidiaries. The financial statements were authorized for issue, in accordance with a resolution of directors, on October 3, 2016.

(a) Basis of preparation

These general purpose financial statements have been prepared in accordance with Australian Accounting Standards and Interpretations issued by the Australian Accounting Standards Board (‘AASB’) and the Corporations Act 2001. Prima BioMed Ltd is a for-profit entity for the purpose of preparing the financial statement.

(i) Compliance with IFRS

The consolidated financial statements of the Prima BioMed Ltd group also comply with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB).

(ii) New and amended standards adopted by the group

None of the new standards and amendments to standards that are mandatory for the first time for the financial year beginning July 1, 2015 affected any of the amounts recognized in the current period or any prior period.

(iii) Historical cost convention

The financial statements have been prepared under the historical cost convention, except for, where applicable, financial assets and liabilities (including derivative financial instruments) at fair value through profit or loss.

(iv) Critical accounting estimates

The preparation of the financial statements requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the consolidated entity’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the financial statements are disclosed in note 3.

(b) Principles of consolidation

Subsidiaries are all entities (included structured entities) over which the group has control. The group controls an entity when the group is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power to direct the activities of the entity. Subsidiaries are fully consolidated from the date on which control is transferred to the group. They are deconsolidated from the date that control ceases.

Intercompany transactions, balances and unrealized gains on transactions between group companies are eliminated. Unrealized losses are also eliminated unless the transaction provides evidence of the impairment of the asset transferred. Accounting policies of subsidiaries have been changed where necessary to ensure consistency with the policies adopted by the group.

(c) Segment reporting

Operating segments are reported in a manner consistent with the internal reporting provided to the chief operating decision maker. The chief operating decision maker (CODM), who is responsible for allocating resources and assessing performance of the operating segments, has been identified as the Board of Directors.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(d) Foreign currency translation

(i) Functional and presentation currency

Items included in the financial statements of each of the group’s entities are measured using the currency of the primary economic environment in which the entity operates (‘the functional currency’). The consolidated financial statements are presented in Australian dollars, which is the Prima BioMed Ltd’s functional and presentation currency.

(ii) Transactions and balances

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at year end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized in profit or loss, except when they are deferred in equity as qualifying cash flow hedges and qualifying net investment hedges or are attributable to part of the net investment in a foreign operation.

Foreign exchange gains and losses that relate to borrowings are presented in the income statement, within finance costs. All other foreign exchange gains and losses are presented separately in the income statement on a net basis.

Non-monetary items that are measured at fair value in a foreign currency are translated using the exchange rates at the date when the fair value was determined. Translation differences on assets and liabilities carried at fair value are reported as part of the fair value gain or loss. For example, translation differences on non-monetary assets and liabilities such as equities held at fair value through profit or loss are recognized in profit or loss as part of the fair value gain or loss and translation differences on non-monetary assets such as equities classified as available-for-sale financial assets are recognized in other comprehensive income.

(iii) Group companies

The results and financial position of foreign operations (none of which has the currency of a hyperinflationary economy) that have a functional currency different from the presentation currency are translated into the presentation currency as follows:

 

    assets and liabilities for each balance sheet presented are translated at the closing rate at the date of that balance sheet

 

    income and expenses for each income statement and statement of comprehensive loss are translated at average exchange rates (unless this is not a reasonable approximation of the cumulative effect of the rates prevailing on the transaction dates, in which case income and expenses are translated at the dates of the transactions), and

 

    all resulting exchange differences are recognized in other comprehensive income.

On consolidation, exchange differences arising from the translation of any net investment in foreign entities, and of borrowings and other financial instruments designated as hedges of such investments, are recognized in other comprehensive income. When a foreign operation is sold or any borrowings forming part of the net investment are repaid, the associated exchange differences are reclassified to profit or loss, as part of the gain or loss on sale.

(e) Revenue recognition

Revenue is measured at the fair value of the consideration received or receivable.

The group recognizes revenue when the amount of revenue can be reliably measured, it is probable that future economic benefits will flow to the entity and specific criteria have been met for each of the group’s activities as described below. The group bases its estimates on historical results, taking into consideration the type of customer, the type of transaction and the specifics of each arrangement.

(i) License revenue

License revenue is recognized on receipt or where there is reasonable assurance that the license revenue will be received.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(e) Revenue recognition (continued)

 

Other income

(i) Interest income

Interest income is recognized as interest accrues using the effective interest method. This is a method of calculating the amortized cost of a financial asset and allocating the interest income over the relevant period using the effective interest rate, which is the rate that exactly discounts estimated future cash receipts through the expected life of the financial asset to the net carrying amount of the financial asset.

(ii) Grant income

Grants from the governments, including Australian Research and Development Rebates and Development Rebates, France’s Crédit d’Impôt Recherche, and Saxony Development Bank (“Sächsische Aufbaubank”) from Germany, are recognized at their fair value when there is a reasonable assurance that the grant will be received and the Company will comply with all attached conditions. Government grants relating to operating costs are recognized in the Statements of Comprehensive Income as other income.

(iii) Miscellaneous income

 

  a. Research collaboration income

The group receives income from undertaking research collaborations with are recognized when the services have been provided.

 

  b. Research material sales

The group receives income from the sale of materials supplied to other researchers in order to conduct further studies on LAG-3 technologies. Income is recognized at the point at which the ownership of material is transferred to third parties.

(f) Income tax

The income tax expense or benefit for the period is the tax payable on the current period’s taxable income based on the applicable income tax rate for each jurisdiction adjusted by changes in deferred tax assets and liabilities attributable to temporary differences and to unused tax losses.

The current income tax charge is calculated on the basis of the tax laws enacted or substantively enacted at the end of the reporting period in the countries where the Company’s subsidiaries operate and generate taxable income. Management periodically evaluates positions taken in tax returns with respect to situations in which applicable tax regulation is subject to interpretation. It establishes provisions where appropriate on the basis of amounts expected to be paid to the tax authorities.

Deferred income tax is provided in full, using the liability method, on temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the consolidated financial statements. However, deferred tax liabilities are not recognized if they arise from the initial recognition of goodwill.

Deferred income tax is also not accounted for if it arises from initial recognition of an asset or liability in a transaction other than a business combination that at the time of the transaction affects neither accounting nor taxable profit or loss. Deferred income tax is determined using tax rates (and laws) that have been enacted or substantially enacted by the end of the reporting period and are expected to apply when the related deferred income tax asset is realized or the deferred income tax liability is settled.

Deferred tax assets are recognized for deductible temporary differences and unused tax losses only if it is probable that future taxable amounts will be available to utilize those temporary differences and losses. Deferred tax liabilities and assets are not recognized for temporary differences between the carrying amount and tax bases of investments in foreign operations where the Company is able to control the timing of the reversal of the temporary differences and it is probable that the differences will not reverse in the foreseeable future.

Deferred tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets and liabilities and when the deferred tax balances relate to the same taxation authority.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(f) Income tax (continued)

 

Current tax assets and tax liabilities are offset where the entity has a legally enforceable right to offset and intends either to settle on a net basis, or to realize the asset and settle the liability simultaneously.

Prima BioMed Ltd and its wholly-owned Australian controlled entities have implemented the tax consolidation legislation. As a consequence, these entities are taxed as a single entity and the deferred tax assets and liabilities of these entities are set off in the consolidated financial statements.

Current and deferred tax is recognized in profit or loss, except to the extent that it relates to items recognized in other comprehensive income or directly in equity. In this case, the tax is also recognized in other comprehensive income or directly in equity, respectively.

(g) Business combinations

The acquisition method of accounting is used to account for all business combinations, regardless of whether equity instruments or other assets are acquired. The consideration transferred for the acquisition of a subsidiary comprises the fair value of the assets transferred, liabilities incurred to the former owners of the acquired business and the equity interests issued by the group. The consideration transferred also includes the fair value of any asset or liability resulting from a contingent consideration agreement, and the fair value of any pre-existing equity interest in the subsidiary.

Identifiable assets acquired and liabilities and contingent liabilities assumed in a business combination are, with limited exceptions, measured initially at their fair values at the acquisition date. The group recognizes and non-controlling interest in the acquired entity on an acquisition-by-acquisition basis either at fair value or at the non-controlling interest’s proportionate share of the acquired entity’s net identifiable assets.

Acquisition-related costs are expensed as incurred.

The excess of the consideration transferred and the amount of any non-controlling interests in the acquiree over the fair value of the Group’s share of the net identifiable assets acquired is required as goodwill. If those amounts are less than the fair value of the net identifiable assets of the subsidiary acquired and the measurement of all amounts has been reviewed, the difference is recognized directly in profit and loss as a bargain purchase.

Where settlement of any part of cash consideration is deferred, the amounts payable in the future are discounted to their present value as at the date of exchange. The discount rate used is the entity’s incremental borrowing rate, being the rate at which a similar borrowing could be obtained from an independent financier under comparable terms and conditions.

Contingent consideration is classified either as equity or a financial liability. Amounts classified as a financial liability are subsequently remeasured to fair value with changes in fair value recognized in profit or loss.

If the business combination is achieved in stages, the acquisition date carrying value of the acquirer’s previously held equity interest in the acquiree is remeasured to fair value at the acquisition date. Any gains or losses arising from such remeasurement are recognized in profit and loss.

(h) Impairment of assets

Goodwill and intangible assets that have a definite useful life are subject to amortization and tested annually for impairment or more frequently if events or changes in circumstances indicate that they might be impaired. Other assets are tested for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its recoverable amount.

The recoverable amount is the higher of an asset’s fair value less costs to sell and value in use. For the purposes of assessing impairment, assets are grouped at the lowest levels for which there are separately identifiable cash inflows which are largely independent of the cash inflows from other assets or groups of assets (cash-generating units). Non-financial assets other than goodwill that suffered impairment are reviewed for possible reversal of the impairment at the end of each reporting period.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(i) Cash and cash equivalents

For the purpose of presentation in the statement of cash flows, cash and cash equivalents includes cash on hand, deposits held at call with financial institutions, other short-term, highly liquid investments with original maturities 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, and bank overdrafts. Bank overdrafts are shown within borrowings in current liabilities in the balance sheet.

(j) Current receivables

Current receivables are recognized initially at fair value and subsequently measured at amortized cost using the effective interest method, less provision for impairment. Amount receivable in relation to Goods and Services Tax (GST) and Value Added Tax (VAT) are due from the local taxation authorities and recorded based on the amount of GST and VAT paid on purchases. They are presented as current assets unless collection is not expected for more than 12 months after the reporting date.

Collectability of current receivables is reviewed on an ongoing basis. Receivables which are known to be uncollectible are written off by reducing the carrying amount. An allowance account is used when there is objective evidence that the group will not be able to collect all amounts due.

(k) Investments and other financial assets

Investments and other financial assets are initially measured at fair value. Transaction costs are included as part of the initial measurement, except for financial assets at fair value through profit or loss. They are subsequently measured at either amortized cost or fair value depending on their classification. Classification is determined based on the purpose of the acquisition and subsequent reclassification to other categories is restricted.

Financial assets are derecognized when the rights to receive cash flows from the financial assets have expired or have been transferred and the consolidated entity has transferred substantially all the risks and rewards of ownership.

Loans and receivables

Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are carried at amortized cost using the effective interest rate method. Gains and losses are recognized in profit or loss when the asset is derecognized or impaired, as well as through the amortization process.

Impairment of financial assets

The group assesses at the end of each reporting period whether there is any objective evidence that a financial asset or group of financial assets is impaired. Objective evidence includes significant financial difficulty of the issuer or obligor; a breach of contract such as default or delinquency in payments; the lender granting to a borrower concessions due to economic or legal reasons that the lender would not otherwise do; it becomes probable that the borrower will enter bankruptcy or other financial reorganization; the disappearance of an active market for the financial asset; or observable data indicating that there is a measurable decrease in estimated future cash flows.

The amount of the impairment allowance for loans and receivables carried at amortized cost is the difference between the asset’s carrying amount and the present value of estimated future cash flows, discounted at the original effective interest rate. If there is a reversal of impairment, the reversal cannot exceed the amortized cost that would have been recognized had the impairment not been made and is reversed to profit or loss.

(l) Plant and equipment

Plant and equipment is stated at historical cost less depreciation. Historical cost includes expenditure that is directly attributable to the acquisition of the items.

Depreciation on other assets is calculated using the straight-line method to allocate their cost, net of their residual values, over their estimated useful lives as follows:

 

    Computers – 3 years

 

    Plant and equipment – 3-5 years

 

    Furniture – 3-5 years

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(l) Plant and equipment (continued)

 

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period.

An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (note 1(h)).

Gains and losses on disposals are determined by comparing proceeds with carrying amount. These are included in profit or loss.

(m) Intangible assets

(i) Intellectual property

Costs incurred in acquiring intellectual property are capitalized and amortized on a straight line basis over a period not exceeding the life of the patents, which averages 14 years. Where a patent has not been formally granted, the company estimates the life of the granted patent in accordance with the provisional application.

Costs include only those costs directly attributable to the acquisition of the intellectual property. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (note 1(h)).

(ii) Research and development

Research expenditure on internal projects is recognized as an expense as incurred. Costs incurred on development projects (relating to the design and testing of new or improved products) are recognized as intangible assets when it is probable that the project will, after considering its commercial and technical feasibility, be completed and generate future economic benefits and its costs can be measured reliably. The expenditure that could be recognized comprises all directly attributable costs, including costs of materials, services, direct labor and an appropriate proportion of overheads. Other expenditures that do not meet these criteria are recognized as an expense as incurred.

As the Company has not met the requirement under the standard to capitalize costs in relation to development, these amounts have been expensed.

Development costs previously recognized as an expense are not recognized as an asset in a subsequent period. Capitalized development costs are recorded as intangible assets and amortized from the point at which the asset is ready for use on a straight line basis over its useful life.

(iii) Goodwill

Goodwill is measured as described in (note 1(g)). Goodwill on acquisitions of subsidiaries is included in intangible assets. Goodwill is not amortized but it is tested for impairment annually or more frequently if events or changes in circumstances indicate that it might be impaired, and is carried at cost less accumulated impairment losses. Gains and losses on the disposal of an entity include the carrying amount of goodwill relating to the entity sold.

(n) Trade and other payables

These amounts represent liabilities for goods and services provided to the group prior to the end of financial year which are unpaid.

The amounts are unsecured and are usually paid within 30 days of recognition. Trade and other payables are presented as current liabilities unless payment is not due within 12 months from the reporting date. They are recognized initially at their fair value and subsequently remeasured at amortized cost using the effective interest method.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(o) Compound instruments

Convertible notes, including the attached options and warrants, issued to Ridgeback Capital Investments are accounted for as share based payments when the fair value of the instruments are higher than the consideration received, representing intangible benefits received from the strategic investor. The difference between the fair value and consideration received at issuance of the convertible notes and attached options and warrants is recognised immediately in profit and loss as a share-based payment charge.

If options or warrants contain a settlement choice between cash or shares, this settlement choice constitutes a compound feature of the convertible notes, which triggers the separation of debt and equity components to be accounted for separately. The liability component is measured at fair value at initial recognition and subsequent changes in fair value are recognised in profit and loss. The difference between the fair value of the convertible notes and the liability component at inception is accounted as an equity element and not remeasured subsequently.

(p) Finance costs

Finance costs are expensed in the period in which they are incurred.

(q) Employee benefits

(i) Short-term obligations

Liabilities for wages and salaries, including non-monetary benefits and accumulating annual leave that are expected to be settled wholly within 12 months after the end of the period in which the employees render the related service are recognized in respect of employees’ services up to the end of the reporting period and are measured at the amounts expected to be paid when the liabilities are settled. Liabilities for non-accumulating sick leave are recognized when the leave is taken and measured at the rates paid or payable.

(ii) Other long-term employee benefit obligations

The liabilities for long service leave and annual leave are not expected to be settled wholly within 12 months after the end of the period in which the employees render the related service. They are therefore recognized in the provision for employee benefits and measured as the present value of expected future payments to be made in respect of services provided by employees up to the end of the reporting period using the projected unit credit method. Consideration is given to expected future wage and salary levels, experience of employee departures and periods of service. Expected future payments are discounted using market yields at the end of the reporting period of corporate bonds with terms and currencies that match, as closely as possible, the estimated future cash outflows. Remeasurements as a result of experience adjustments and changes in actuarial assumptions are recognized in profit or loss. The obligations are presented as current liabilities in the balance sheet if the entity does not have an unconditional right to defer settlement for at least twelve months after the reporting period, regardless of when the actual settlement is expected to occur.

(iii) Retirement benefit obligations

The group does not maintain a group superannuation plan. The group makes fixed percentage contributions for all Australian resident employees to complying third party superannuation funds. The group has no statutory obligation and does not make contributions on behalf of its resident employees in the USA and Germany. The group’s legal or constructive obligation is limited to these contributions. Contributions to complying third party superannuation funds are recognized as an expense as they become payable.

(iv) Share-based payments

Share-based compensation benefits are provided to employees via the Executive Incentive Plan (EIP) and Global Employee Shares Option Plan (GESOP). Information relating to these schemes is set out in note 31.

The fair value of performance rights and options granted under the EIP and GESOP are recognized as an employee benefits expense with a corresponding increase in equity. The total amount to be expensed is determined by reference to the fair value of the options granted, which includes any market performance conditions and the impact of any non-vesting conditions but excludes the impact of any service and non-market performance vesting conditions.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

Non-market vesting conditions are included in assumptions about the number of options that are expected to vest. The total expense is recognized over the vesting period, which is the period over which all of the specified vesting conditions are to be satisfied. At the end of each period, the entity revises its estimates of the number of options that are expected to vest based on the non-marketing vesting conditions. It recognizes the impact of the revision to original estimates, if any, in profit or loss, with a corresponding adjustment to equity.

(v) Termination benefits

Termination benefits are payable when employment is terminated before the normal employment contract expiry date. The group recognizes termination benefits when it is demonstrably committed to terminating the employment of current employees.

(vi) Bonus plan

The group recognizes a liability and an expense for bonuses. The group recognizes a provision where contractually obliged or where there is a past practice that has created a constructive obligation.

(r) 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.

(s) Earnings per share

(i) Basic earnings per share

Basic earnings per share is calculated by dividing:

 

    the profit or loss attributable to owners of the Company

 

    by the weighted average number of ordinary shares outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the year. Bonus elements have been included in the calculation of the weighted average number of ordinary shares and has been retrospectively applied to the prior financial year.

(ii) Diluted earnings per share

Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account:

 

    the after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares, and

 

    the weighted average number of additional ordinary shares that would have been outstanding assuming the conversion of all dilutive potential ordinary shares.

(t) Goods and Services Tax and other similar taxes (‘GST’)

Revenues, expenses and assets are recognized net of the amount of associated GST, unless the GST incurred is not recoverable from the taxation authority. In this case it is recognized as part of the cost of acquisition of the asset or as part of the expense.

Receivables and payables are stated inclusive of the amount of GST receivable or payable. The net amount of GST recoverable from, or payable to, the taxation authority is included with other receivables or payables in the balance sheet.

Cash flows are presented on a gross basis. The GST components of cash flows arising from investing or financing activities which are recoverable from, or payable to the taxation authority, are presented as operating cash flows.

Commitments and contingencies are disclosed net of the amount of GST recoverable from, or payable to, the tax authority.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(u) New Accounting Standards and Interpretations not yet mandatory or early adopted

Certain new accounting standards and interpretations have been published that are not mandatory for 30 June 2016 reporting periods and have not been early adopted by the company. The company’s assessment of the impact of these new standards and interpretations is set out below:

 

  (i) AASB 15 (IFRS 15) Revenue from Contracts with Customers—The AASB has issued a new standard for the recognition of revenue. This will replace AASB 118 (IAS 18) which covers revenue arising from the sale of goods and the rendering of services and AASB 111 (IAS 11) which covers construction contracts. The new standard is based on the principle that revenue is recognised when control of a good or service transfers to a customer. The standard permits either a full retrospective or a modified retrospective approach for the adoption. It applies to annual reporting periods commencing on or after 1 January 2018. Management has performed a preliminary assessment of the impact of the new standard and has not identified any instances where the new standard requirements will have a material impact on the financial statements of the Company.

 

  (ii) AASB 9 (IFRS 9) Financial Instruments—AASB 9 (IFRS 9) addresses the classification, measurement and derecognition of financial assets and financial liabilities, introduces new rules for hedge accounting and a new impairment model for financial assets. It applies to annual reporting periods commencing on or after 1 January 2018. Management has performed a preliminary assessment of the impact of the new standard and has not identified any instances where the new standard requirements will have a material impact on the financial statements of the Company.

 

  (iii) AASB 16 (IFRS 16) Leases—The AASB 16 (IFRS 16) has issued a new standard for the accounting of leases. The new standard will predominantly affect lessees, with almost all leases brought onto the balance sheet. It applies to annual reporting periods commencing on or after 1 January 2019. Management has performed a preliminary assessment of the impact of the new standard and has not identified any instances where the new standard requirements will have a material impact on the financial statements of the Company.

There are no other standards and interpretations that are not yet effective and that are expected to have a material impact on the Group in the current or future reporting periods and on foreseeable future transactions.

(v) Parent entity financial information

The financial information for the parent entity, Prima BioMed Ltd, disclosed in note 32 has been prepared on the same basis as the consolidated financial statements, except as set out below.

(i) Investments in subsidiaries, associates and joint venture entities

Investments in subsidiaries are accounted for at cost in the financial statements of Prima BioMed Ltd.

(ii) Tax consolidation legislation

Prima BioMed Ltd and its wholly-owned Australian controlled entities have implemented the tax consolidation legislation. The head entity, Prima BioMed Ltd, and the controlled entities in the tax consolidated group account for their own current and deferred tax amounts. These tax amounts are measured as if each entity in the tax consolidated group continues to be a stand-alone taxpayer in its own right.

The entities have also entered into a tax funding agreement under which the wholly-owned entities fully compensate for any current tax payable assumed and are compensated by the head entity for any current tax receivable and deferred tax assets relating to unused tax losses or unused tax credits that are transferred to the head entity under the tax consolidation legislation. The funding amounts are determined by reference to the amounts recognized in the wholly-owned entities’ financial statements.

 

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NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

(v) Parent entity financial information (continued)

 

The amounts receivable/payable under the tax funding agreement is due upon receipt of the funding advice from the head entity, which is issued as soon as practicable after the end of each financial year. The head entity may also require payment of interim funding amounts to assist with its obligations to pay tax installments. Assets or liabilities arising under tax funding agreements with the tax consolidated entities are recognized as current amounts receivable from or payable to other entities in the group. 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.

(iii) Share-based payments

The grant by the company of options over its equity instruments to the employees of subsidiary undertakings in the group is treated as a capital contribution to that subsidiary undertaking. The fair value of employee services received, measured by reference to the grant date fair value, is recognized over the vesting period as an increase to investment in subsidiary undertakings, with a corresponding credit to equity.

NOTE 2. FINANCIAL RISK MANAGEMENT

The group’s activities expose it to a variety of financial risks: market risk (including currency risk), credit risk and liquidity risk. The group’s overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on the financial performance of the group. The group may use derivative financial instruments such as foreign exchange contracts to hedge certain risk exposures. Derivatives are exclusively used for hedging purposes, i.e. not as trading or other speculative instruments. The group hedges its foreign exchange risk exposure arising from future commercial transactions and recognized assets and liabilities using forward contracts or natural hedging. The group uses different methods to measure different types of risk to which it is exposed. These methods include sensitivity analysis and cash flow forecasting in the case of foreign exchange and aging analysis for credit risk.

Risk management is carried out by senior management under policies approved by the board of directors. Management identifies, evaluates and hedges financial risks in close co-operation with the group’s operating units. The board provides the principles for overall risk management, as well as policies covering specific areas, such as foreign exchange risk, interest rate risk, credit risk, use of derivative financial instruments and non-derivative financial instruments, and investment of excess liquidity.

(a) Market risk

Foreign exchange risk

The group operates internationally and is exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the US dollar and Euro. Foreign exchange risk arises from future commercial transactions and recognized assets and liabilities denominated in a currency that is not the entity’s functional currency. The risk is measured using sensitivity analysis and cash flow forecasting.

Management has set up a policy to manage the company’s exchange risk within the group companies. The group hedges its foreign exchange risk exposure arising from future commercial transactions and recognized assets and liabilities using forward contracts or natural hedging.

The group considers using forward exchange contracts to cover anticipated cash flow in USD and Euro periodically, as derivatives held for trading and measured through the income statement. This policy is reviewed regularly by directors from time to time. There were no outstanding foreign exchange contracts as at 30 June 2016 and 30 June 2015.

 

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NOTE 2. FINANCIAL RISK MANAGEMENT (continued)

 

The group’s exposure to foreign currency risk at the end of the reporting period, expressed in Australian dollar, was as follows:

 

     June 30, 2016      June 30, 2015  
     USD      EUR      USD      EUR  

Cash in bank

     1,428,959         7,261,477         839,185         1,813,642   

Trade and other receivables

     27,205         29,539         126,958         34,592   

Trade and other payables

     (10,993      (256,364      (221,097      (201,561

Borrowings

     —           —           (822,930      (300,000

Sensitivity

Based on the financial assets and liabilities held at June 30, 2016, had the Australian dollar weakened/ strengthened by 10% against the US dollar with all other variables held constant, the group’s post-tax loss for the year would have been $194,610 higher/$194,610 lower (2015 – $10,141 higher/$10,141 lower). Any impact on the equity will result in changes in retained earnings.

Based on the financial instruments held at June 30, 2016, had the Australian dollar weakened/ strengthened by 10% against the Euro with all other variables held constant, the group’s post-tax loss for the year would have been $1,050,105 higher/$1,050,105 lower (2015 – $196,137higher/$196,137 lower), mainly as a result of foreign exchange gains/losses on translation of Euro denominated financial instruments.

The group’s exposure to other foreign exchange movements is not material.

(b) Credit risk

Credit risk is managed on a group basis. Credit risk arises from cash and cash equivalents, derivative financial instruments and deposits with banks. For banks, only independently rated parties with a minimum rating of ‘A’ according to Standard & Poor’s are accepted.

The credit quality of financial assets that are neither past due nor impaired can be assessed by reference to external credit ratings:

 

     30 June 2016      30 June 2015  
     $      $  

Cash at bank and short-term bank deposits

     

AA-

     20,879,548         6,759,615   

(c) Liquidity risk

Prudent liquidity risk management implies maintaining sufficient cash to meet obligations when due. At the end of the reporting period the group held deposits at call of $20,879,548 (2015 $6,759,615) that are expected to readily generate cash inflows for managing liquidity risk. Management monitors rolling forecasts of the group’s liquidity reserve cash and cash equivalents (note 7) on the basis of expected cash flows. In addition, the group’s liquidity management policy involves projecting cash flows in major currencies and considering the level of liquid assets necessary to meet these.

As outlined in Note 3, the company’s monitoring of its cash requirements extends to the consideration of potential capital raising strategies and an active involvement with its institutional and retail investor base.

Maturities of financial liabilities

The tables below analyze the group’s financial liabilities into relevant maturity groupings based on their contractual maturities for:

 

  (a) all non-derivative financial liabilities, and

 

  (b) net and gross settled derivative financial instruments for which the contractual maturities are essential for an understanding of the timing of the cash flows.

 

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Table of Contents

NOTE 2. FINANCIAL RISK MANAGEMENT (continued)

 

The amounts disclosed in the table are the contractual undiscounted cash flows. Balances due within 12 months equal their carrying balances as the impact of discounting is not significant.

 

Contractual maturities of financial liabilities

At June 30, 2016

   Less than
6 months

$
     More than
5 years

$
     Total
contractual
cash flows

$
     Carrying
Amount
(assets) /
liabilities

$
 

Non-Derivatives

           

Trade and other payables

     1,422,798         —           1,422,798         1,422,798   

Convertible note liability (refer note 15)

     —           17,876,076         17,876,076         5,027,168   
  

 

 

    

 

 

    

 

 

    

 

 

 
     1,422,798         17,876,076         19,298,874         6,449,966   
  

 

 

    

 

 

    

 

 

    

 

 

 

Contractual maturities of financial liabilities

At June 30, 2015

   Less than
6 months

$
     More than
5 years

$
     Total
contractual
cash flows

$
     Carrying
Amount
(assets) /
liabilities

$
 

Non-Derivatives

           

Trade and other payables

     2,770,049         —           2,770,049         2,770,049   

Borrowings

     1,508,473         —           1,508,473         1,508,473   
  

 

 

    

 

 

    

 

 

    

 

 

 
     4,278,522         —           4,278,522         4,278,522   
  

 

 

    

 

 

    

 

 

    

 

 

 

(d) Fair value measurements

The following table presents the group’s financial assets and financial liabilities measured and recognized at fair value at June 30, 2016 and June 30, 2015 on a recurring basis:

 

     Level 1      Level 2      Level 3      Total  

At 30 June 2016

   $      $      $      $  

Liabilities

           

Convertible note liability

     —           —           5,027,168         5,027,168   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total liabilities

     —           —           5,027,168         5,027,168   
  

 

 

    

 

 

    

 

 

    

 

 

 
     Level 1      Level 2      Level 3      Total  

At 30 June 2015

   $      $      $      $  

Assets

           

Comparability milestone at fair value

     —           —           542,075         542,075   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Assets

     —           —           542,075         542,075   
  

 

 

    

 

 

    

 

 

    

 

 

 

(i) Valuation techniques used to determine fair values

Level 1: The fair value of financial instruments trade in active markets (such as publicly traded derivatives, and trading and available-for-sale securities) is based on quoted (unadjusted) market prices at the end of the reporting period. The quoted market price used for financial assets held by the group is the current bid price. These instruments are included in level 1.

Level 2: The fair value of financial instruments that are not traded in an active market (for example over-the-counter derivatives) is determined using valuation techniques. These valuation techniques maximize the use of observable market data where it is available and rely as little as possible on entity specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2

 

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Table of Contents

NOTE 2. FINANCIAL RISK MANAGEMENT (continued)

 

Level 3: If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. This is the case for unlisted equity securities.

Specific valuation techniques used to value financial instruments include:

 

    The use of quoted market prices or dealer quotes for similar instruments

 

    The fair value of interest rate swaps is calculated as the present value of the estimated future cash flows based on observable yield curves

 

    The fair value of forward foreign exchange contracts is determined using forward exchange rates at the balance sheet date

 

    The fair value of the remaining financial instruments is determined using discounted cash flow analysis.

(ii) Fair value measurements using significant unobservable inputs (level 3)

The following table presents the changes in level 3 instruments for the year ended 30 June 2016:

 

     Comparability
milestone
     Convertible note
liability
     Total  
     $      $      $  

Opening balance 1 July 2015

     542,075         —           542,075   

Other increases/(decreases)

     —           (4,419,531      (4,419,531

Changes in fair value

     —           (607,637      (607,637

(Losses)/gains recognized as an expense

     (542,075      —           (542,075
  

 

 

    

 

 

    

 

 

 

Closing balance 30 June 2016

     —           (5,027,168      (5,027,168
  

 

 

    

 

 

    

 

 

 

(iii) Valuation inputs and relationships to fair value

The following table summarizes the quantitative information about the significant inputs used in level 3 fair value measurements:

 

Description

   Fair value at
30 June 2016

$
    

Unobservable inputs

   Range of inputs  

Convertible note

     5,027,168      

Face value

Interest rate of note

Risk adjusted interest rate

    

 

 

13,750,828

3%

15%

  

  

  

(iv) Valuation process

The convertible note was valued using a Black Scholes model. Prima used valuation specialists to perform these valuations based on the inputs above.

NOTE 3. CRITICAL ACCOUNTING JUDGEMENTS, ESTIMATES AND ASSUMPTIONS

Estimates and judgments are continually evaluated and are based on historical experience and other factors, including expectations of future events that may have a financial impact on the entity and that are believed to be reasonable under the circumstances.

The group makes estimates and assumptions concerning the future. The resulting accounting estimates will, by definition, seldom equal the related actual results. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.

 

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Table of Contents

NOTE 3. CRITICAL ACCOUNTING JUDGEMENTS, ESTIMATES AND ASSUMPTIONS (continued)

 

Income taxes

The group has recognized deferred tax assets of $2.42m which related to carried forward tax losses in the Immutep subsidiary acquired in the prior year. On acquisition, the group has recognized significant amortizing IP intangibles for which there will be no corresponding tax deduction, giving rise to a future taxable temporary difference and required the recognition of a deferred tax liability as part of the business combination accounting. The entity had previously unrecognized tax losses which management is satisfied will continue to be available to be utilized by the subsidiary after the acquisition. As such, the group has recognized a deferred tax asset to the extent of the deferred tax liability recognized on acquisition. The group has concluded that the deferred assets will be recoverable to the extent of the deferred tax liability recognized at each year.

All other remaining deferred tax assets relating to carried forward tax losses and taxable temporary differences have not been recognized since the group is currently in a loss making position and unable to generate taxable income to utilize the carried forward tax losses and taxable temporary differences. The utilization of the tax losses also depends on the ability of the entity to satisfy certain tests at the time the losses are recouped. The group is subject to income taxes in Australia and jurisdictions where it has foreign operations. Significant judgement is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The group estimates its tax liabilities based on the group’s understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.

Research and development

The consolidated entity has expensed all internal research and development expenditure incurred during the year as the costs relate to the initial expenditure for research and development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the current stage of development. It was considered appropriate to expense the research and development costs as they did not meet the criteria to be capitalized under AASB 138 (IAS 38) Intangible Assets .

Going Concern

The Group has experienced significant recurring operating losses and negative cash flows from operating activities since its inception. As at 30 June 2016, the Group holds cash and cash equivalents of $20,879,548 (2015: $6,759,615). In line with the Company’s financial risk management, the directors have carefully assessed the financial and operating implications of the above matters, including the expected cash outflows of ongoing research and development activities of the Company over the next 12 months. Based on this consideration, the directors are of the view that the Group will be able to pay its debts as and when they fall due for at least 12 months following the date of these financial statements and that it is appropriate for the financial statements to be prepared on a going concern basis.

Monitoring and addressing the ongoing cash requirements of the Group is a key focus of the directors. This involves consideration of alternative future capital raising initiatives and an active engagement with potential retail and institutional investors alike.

Amortization of intellectual property

Costs incurred in acquiring intellectual property are capitalized and amortized on a straight line basis over a period not exceeding the life of the patents, which averages 15 years. Where a patent has not been formally granted, the company estimates the life of the granted patent in accordance with the provisional application.

Costs include only those costs directly attributable to the acquisition of the intellectual property. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is greater than its estimated recoverable amount (note 1(h)).

 

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Table of Contents

NOTE 4. SEGMENT REPORTING

Identification of reportable operating segments

Operating segments are reported in a manner consistent with internal reports which are reviewed and used by Management and the Board of Directors (who are identified as the Chief Operating Decision Makers (‘CODM’)). The Group operates in one operating segment, being Cancer Immunotherapy.

Operating segment information

 

June 30, 2016

   Cancer
Immunotherapy
A$
    
Unallocated
A$
     Consolidated
A$
 

Revenue

        

License revenue.

     175,052         —           175,052   

Other income

        

Miscellaneous income

     702,743         —           702,743   

Grant income

     887,083         —           887,083   

Interest income

     —           264,043         264,043   

Total revenue and other income

     1,764,878         264,043         2,028,921   

Segment Result

     (63,460,244      —           (63,460,244

Loss before income tax expense

     (63,460,244      264,043         (63,196,201

Income tax benefit

           1,181,017   
        

 

 

 

Loss after income tax expense

           (62,015,184
        

 

 

 

Total segment assets

     42,554,067         —           42,554,067   

Total segment liabilities

     7,236,554         —           7,236,554   

June 30, 2015

   Cancer
Immunotherapy
A$
    
Unallocated
A$
     Consolidated
A$
 

Revenue

        

License revenue.

     —           —           —     

Other income

        

Miscellaneous income

     168,322        —           168,322   

Grant income

     1,167,190         —           1,167,190   

Net gain on foreign exchange

     —           538,248         538,428   

Interest income

     —           219,107         219,107   

Total revenue and other income

     1,335,512         757,355         2,092,867   

Segment Result

     (33,051,207      —           (33,051,207

Loss before income tax expense

     (33,051,207      757,355         (32,293,852

Income tax benefit

           142,156   
        

 

 

 

Loss after income tax expense

           (32,151,696
        

 

 

 

Total segment assets

     30,983,445         —           30,983,455   

Total segment liabilities

     6,293,702         —           6,293,702   

 

F-21


Table of Contents

NOTE 4. SEGMENT REPORTING (continued)

 

June 30, 2014

   Cancer
Immunotherapy
A$
    
Unallocated
A$
     Consolidated
A$
 

Revenue

        

License revenue.

     —           —           —     

Other income

        

Miscellaneous income

     —           15,929         15,929   

Grant income

     2,004,198         —           2,004,198   

Net gain on foreign exchange

     —           406,628         406,628   

Interest income

     —           713,311         713,311   

Total revenue and other income

     2,004,198         1,135,868         3,140,066   

Segment Result

     (11,819,437      (1,510,337      (13,329,774

Loss before income tax expense

     (11,819,437      (1,510,337      (13,329,774

Income tax expense

           (13,607
        

 

 

 

Loss after income tax expense

           (13,343,381
        

 

 

 

Total segment assets

     25,377,955         —           25,377,955   

Total segment liabilities

     2,785,635         —           2,785,635   

NOTE 5. EXPENSES

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Loss before income tax includes the following specific expenses:

        

Research & Development and Intellectual Property

        

Research and development

     6,382,377         8,515,150         11,825,668   

Intellectual property management

     677,151         437,297         105,189   
  

 

 

    

 

 

    

 

 

 

Total Research & Development and Intellectual Property

     7,059,528         8,952,447         11,930,857   
  

 

 

    

 

 

    

 

 

 

Corporate administrative expenses

        

Auditor’s remuneration

     441,741         292,807         222,720   

Directors fee and employee expenses

     3,714,522         2,508,533         1,969,494   

Administrative expenses

     2,826,366         2,921,766         1,900,409   
  

 

 

    

 

 

    

 

 

 

Total corporate administrative expenses

     6,982,629         5,723,106         4,092,623   
  

 

 

    

 

 

    

 

 

 

Depreciation

        

Plant and equipment

     168,924         308,719         370,237   

Computers

     10,676         14,523         18,987   

Furniture and fittings

     2,776         2,532         2,698   
  

 

 

    

 

 

    

 

 

 

Total depreciation

     182,376         325,774         391,922   
  

 

 

    

 

 

    

 

 

 

Amortization

        

Patents

     61,881         55,002         54,438   

Intellectual Property Assets R&D

     1,748,836         960,426         —     
  

 

 

    

 

 

    

 

 

 

Total amortization

     1,810,717         1,015,428         54,438   
  

 

 

    

 

 

    

 

 

 

Total depreciation and amortization

     1,993,093         1,341,202         446,360   
  

 

 

    

 

 

    

 

 

 

(Gain)/loss on disposal of assets

        

Plant and equipment

     (18,493      5,160         —     
  

 

 

    

 

 

    

 

 

 

Finance expenses

        

Interest expenses

     8,199         26,789         —     

Other finance expenses – note 18

     —           18,338,015         —     
  

 

 

    

 

 

    

 

 

 

Finance expense

     8,199         18,364,804         —     
  

 

 

    

 

 

    

 

 

 

 

F-22


Table of Contents

NOTE 5. EXPENSES (continued)

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Loss on foreign exchange

     563,890         —           —     
  

 

 

    

 

 

    

 

 

 

Changes in fair value of comparability milestone

     542,075         —           —     
  

 

 

    

 

 

    

 

 

 

Share Based Payment to strategic investor

     47,468,071         —           —     
  

 

 

    

 

 

    

 

 

 

 

F-23


Table of Contents

NOTE 6. INCOME TAX EXPENSE

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Current tax

        

Current tax on profits for the year

     3,121         1,908        13,607  
  

 

 

    

 

 

    

 

 

 

Total current tax expense

     3,121         1,908         13,607   
  

 

 

    

 

 

    

 

 

 

Deferred income tax

        

Increase in deferred tax assets (note 12)

     (921,463      —           —     

Decrease in deferred tax liabilities (note 12)

     (262,675      (144,064      —     
  

 

 

    

 

 

    

 

 

 

Total deferred tax (benefit)/expense

     (1,184,138      (144,064      —     
  

 

 

    

 

 

    

 

 

 

Income tax (benefit)/expense

     (1,181,017      (142,156      13,607   
  

 

 

    

 

 

    

 

 

 

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Numerical reconciliation of income tax expense to prima facie tax payable

        

Loss before income tax expense

     (63,196,201      (32,293,852      (13,329,774

Tax at the Australian tax rate of 30%

     (18,958,860      (9,688,156      (3,998,932

Tax effect amounts which are not deductible/(taxable) in calculating taxable income:

        

Non-deductible share based payments

     14,858,019         226,653         —     

Non-deductible financing costs

     —           5,501,405         —     

Other non-deductible expenses

     598,016         306,360         439,651   

Non-assessable income

     (266,125      (233,261      (479,616

Capital listing fee

     (90,305      (188,530      (586,143

Difference in overseas tax rates*

     1,184,138         184,251         569   
  

 

 

    

 

 

    

 

 

 
     (2,675,117      (3,891,278      (4,624,471

Net adjustment to deferred tax assets and liabilities for tax losses and temporary differences not recognized

     1,494,100         3,749,122         4,638,078   
  

 

 

    

 

 

    

 

 

 

Income tax expense**

     (1,181,017      (142,156      13,607   
  

 

 

    

 

 

    

 

 

 

 

* Difference in overseas tax rate is as a result of reduced corporate income tax rate of 15% applicable to the Immutep subsidiary.
** Income tax expense relates to tax payable in the United States and movement in deferred tax assets and liabilities for the French subsidiary.

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Deferred tax assets not recognized

        

Deferred tax assets not recognized comprises temporary differences attributable to:

        

Carried forward tax losses benefit

     32,044,352         31,262,135         27,329,078   

Temporary differences

     438,284         (196,493      (402,644
  

 

 

    

 

 

    

 

 

 

Total deferred tax assets not recognized

     32,482,636         31,065,642         26,926,434   
  

 

 

    

 

 

    

 

 

 

 

F-24


Table of Contents

NOTE 6. INCOME TAX EXPENSE (continued)

 

The above potential tax benefit, which includes tax losses and temporary differences has not been recognized in the consolidated balance sheet as the recovery of this benefit is not probable. There is no expiration date for the tax losses carried forward. The estimated amount of cumulative tax losses at 30 June 2016 was $106,814,506 (2015 – $104,207,118). Utilization of these tax losses is dependent on the parent entity satisfying certain tests at the time the losses are recouped.

NOTE 7. CASH AND CASH EQUIVALENTS

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Cash on hand

     114         1,296   

Cash at bank

     20,619,806         6,508,319   

Cash on deposit

     259,628         250,000   
  

 

 

    

 

 

 
     20,879,548         6,759,615   
  

 

 

    

 

 

 

The above cash and cash equivalent are held in AUD, USD, and Euro. The interest rate on these deposits range from 0% to 2.05% in 2016 (2015 – 0% to 2.3%).

NOTE 8. CURRENT RECEIVABLES

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

GST receivable

     73,640         150,143   

Other receivables

     94,660         165,310   
  

 

 

    

 

 

 
     168,300         315,453   
  

 

 

    

 

 

 

Due to the short term nature of these receivables, the carrying value is assumed to be their fair value and at 30 June 2016. No receivables were impaired or past due.

NOTE 9. OTHER CURRENT ASSETS

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Prepayments*

     591,926         380,749   

Security deposit

     30,890         21,224   

Accrued interest

     204         3,955   

Comparability milestone

     —           542,075   
  

 

 

    

 

 

 
     623,020         948,003   
  

 

 

    

 

 

 

 

* Prepayments are in relation to the deposits paid to organizations involved in the clinical trials.

 

F-25


Table of Contents

NOTE 10. NON-CURRENT ASSETS – PLANT AND EQUIPMENT

 

     Plant and
Equipment
A$
    Computer
A$
    Furniture
and
fittings
A$
    Total
A$
 

At June 30, 2014

        

Cost or fair value

     1,248,948        62,789        12,765        1,324,502   

Accumulated depreciation

     (701,967     (39,603     (5,668     (747,238
  

 

 

   

 

 

   

 

 

   

 

 

 

Net book amount

     546,981        23,186        7,097        577,264   
  

 

 

   

 

 

   

 

 

   

 

 

 

Year ended June 30, 2015

        

Opening net book amount

     546,981        23,186        7,097        577,264   

Exchange differences

     (681     1,128        (22     425   

Additions

     44,627        4,201        —          48,828   

Disposals

     (178     (5,332     —          (5,510

Acquisition of subsidiary

     787        1,937        —          2,724   

Depreciation charge

     (308,719     (14,523     (2,532     (325,774
  

 

 

   

 

 

   

 

 

   

 

 

 

Closing net book amount

     282,817        10,597        4,543        297,957   
  

 

 

   

 

 

   

 

 

   

 

 

 

At June 30, 2015

        

Cost or fair value

     605,648        28,016        7,172        640,836   

Accumulated depreciation

     (322,831     (17,419     (2,629     (342,879
  

 

 

   

 

 

   

 

 

   

 

 

 

Net book amount

     282,817        10,597        4,543        297,957   
  

 

 

   

 

 

   

 

 

   

 

 

 

Year ended June 30, 2016

        

Opening net book amount

     282,817        10,597        4,543        297,957   

Exchange differences

     10,518        391        168        11,077   

Additions

     12,969        13,447        714        27,130   

Disposals

     (122,289     —          —          (122,289

Depreciation charge

     (168,924     (10,676     (2,775     (182,375
  

 

 

   

 

 

   

 

 

   

 

 

 

Closing net book amount

     15,091        13,759        2,650        31,500   
  

 

 

   

 

 

   

 

 

   

 

 

 

At June 30, 2016

        

Cost or fair value

     511,195        41,971        8,064        561,230   

Accumulated depreciation

     (496,104     (28,212     (5,414     (529,730
  

 

 

   

 

 

   

 

 

   

 

 

 

Net book amount

     15,091        13,759        2,650        31,500   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

F-26


Table of Contents

NOTE 11. NON-CURRENT ASSETS – INTANGIBLES

 

     Patents
A$
     Intellectual
Property
Assets
A$
     Goodwill
A$
     Total
A$
 

At June 30, 2014

           

Cost

     1,915,671         —           —           1,915,671   

Accumulated amortization and impairment

     (1,798,788      —           —           (1,798,788
  

 

 

    

 

 

    

 

 

    

 

 

 

Net book amount

     116,883         —           —           116,883   
  

 

 

    

 

 

    

 

 

    

 

 

 

Year ended June 30, 2015

           

Opening net book amount

     116,883         —           —           116,883   

Acquisition of Immutep S.A

     —           23,451,000         109,962         23,560,962   

Amortization charge

     (55,002      (960,426      —           (1,015,428
  

 

 

    

 

 

    

 

 

    

 

 

 

Closing net book amount

     61,881         22,490,574         109,962         22,662,417   
  

 

 

    

 

 

    

 

 

    

 

 

 

At June 30, 2015

           

Cost or fair value

     1,915,671         23,451,000         109,962         25,476,633   

Accumulated amortization and impairment

     (1,853,790      (960,426      —           (2,814,216
  

 

 

    

 

 

    

 

 

    

 

 

 

Net book amount

     61,881         22,490,574         109,962         22,662,417   
  

 

 

    

 

 

    

 

 

    

 

 

 

Year ended June 30, 2016

           

Opening net book amount

     61,881         22,490,574         109,962         22,662,417   

Amortization charge

     (61,881      (1,748,837      —           (1,810,718
  

 

 

    

 

 

    

 

 

    

 

 

 

Closing net book amount

     —           20,741,737         109,962         20,851,699   
  

 

 

    

 

 

    

 

 

    

 

 

 

At June 30, 2016

           

Cost or fair value

     1,915,671         23,451,000         109,962         25,476,633   

Accumulated amortization and impairment

     (1,915,671      (2,709,263      —           (4,624,934
  

 

 

    

 

 

    

 

 

    

 

 

 

Net book amount

     —           20,741,737         109,962         20,851,699   
  

 

 

    

 

 

    

 

 

    

 

 

 

(i) Amortization methods and useful lives

The group amortizes intangible assets with a limited useful life using the straight-line method over the following periods:

 

    Patents, trademark and licenses – 13 – 21 years

 

    Intellectual property assets – 14 years

NOTE 12. DEFERRED TAX BALANCES

(i) Deferred tax assets

The balance comprises temporary differences attributable to:

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Tax losses

     2,417,066         1,495,603   

Total deferred tax assets

     2,417,066         1,495,603   

Set-off of deferred tax liabilities pursuant to set-off provisions

     (2,417,066      (1,495,603
  

 

 

    

 

 

 

Net deferred tax assets

     —           —     
  

 

 

    

 

 

 

 

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Table of Contents

NOTE 12. DEFERRED TAX BALANCES (continued)

 

(ii) Expected recovery of Deferred Tax Assets

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Deferred tax assets expected to be recovered within 12months

     262,325         262,325   

Deferred tax assets expected to be recovered after more than 12 months

     2,154,741         1,233,278   

Net deferred tax assets

     2,417,066         1,495,603   

(iii) Deferred tax liabilities

The balance comprises temporary differences attributable to:

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Intangible assets

     3,111,260         3,373,936   

Total deferred tax liabilities

     3,111,260         3,373,936   

Set-off of deferred tax liabilities pursuant to set-off provisions

     (2,417,066      (1,495,603
  

 

 

    

 

 

 

Net deferred tax liabilities

     694,194         1,878,333   
  

 

 

    

 

 

 

Deferred tax liabilities expected to be settled within 12 months

     262,325         232,625   

Deferred tax liabilities expected to be settled more than 12 months

     431,869         1,616,008   
  

 

 

    

 

 

 
     694,194         1,878,333   
  

 

 

    

 

 

 

(iv) Movements in deferred tax balances

 

     Tax Losses
A$
     Intangible Assets
A$
     Total
A$
 

Movement

        

At 30 June 2015

     1,495,603         (3,373,936      (1,878,333

(Charged)/credited

        

– to profit or loss

     921,463         262,676         1,184,139   

– to other comprehensive income

     —           —           —     

– directly to equity

     —           —           —     
  

 

 

    

 

 

    

 

 

 

At 30 June 2016

     2,417,066         (3,111,260      (694,194
  

 

 

    

 

 

    

 

 

 

 

F-28


Table of Contents

NOTE 13. CURRENT LIABILITES – TRADE AND OTHER PAYABLES

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Trade payables

     561,263         2,201,864   

Other payables and accruals

     861,535         568,185   
  

 

 

    

 

 

 
     1,422,798         2,770,049   
  

 

 

    

 

 

 

NOTE 14. CURRENT LIABILITES – BORROWINGS

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Amounts payable to related parties

     —           1,071,523   

Other borrowings

     —           436,950   
  

 

 

    

 

 

 
     —           1,508,473   
  

 

 

    

 

 

 

In the prior year, Dr Frédéric Triebel provided an unsecured loan to the company of $1,071,523. Interest is charged on this loan at the rate of 10% per annum and was repaid in full in August 2015.

Other borrowings relate to an interest-free loan advanced by France’s innovation agency, ANVAR, which was repaid in full in July 2015.

 

F-29


Table of Contents

NOTE 15. NON CURRENT LIABILITES – CONVERTIBLE NOTE

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Convertible note at fair value

     5,027,168         —     
  

 

 

    

 

 

 
     5,027,168         —     
  

 

 

    

 

 

 

On 11 May 2015, the Company entered into a subscription agreement with Ridgeback Capital Investments (Ridgeback) to invest in Convertible Notes and Warrants of the Company for cash consideration totaling $13,750,828, which was subject to shareholder approval at an Extraordinary General Meeting. Shareholder approval was received on 31 July 2015.

The 13,750,828 Convertible Notes issued have a face value of $1.00 per note which are exercisable at a price of $0.02 per share, mature on 4 August 2025 and accrue interest at a rate of 3% per annum which may also be converted into shares. Conversions may occur during the period (i) at least 3 months after the Issue Date and (ii) at least 15 business days prior to the maturity date into 50 ordinary shares of the Company per note (subject to customary adjustments for rights or bonus issues, off market buybacks, issues at less than current market price, share purchase plan, dividend reinvestment plan at a discount, return of capital or dividend or other adjustment). If a change of control event, delisting event or event of default has occurred, Ridgeback may elect to convert the notes into shares or repayment of principal and interest. The Convertible Notes rank at least equal with all present and future unsubordinated and unsecured debt obligations of the Company and contain customary negative pledges regarding financial indebtedness, dividend payments, related party transaction and others.

8,475,995 Warrants were granted to Ridgeback which are exercisable at a price of $0.025 per share on or before 4 August 2025. 371,445,231 Warrants were granted to Ridgeback which are exercisable at a price of $0.0237 per share on or before 4 August 2020. All warrants may be settled on a gross or net basis and the number of warrants or exercise price may be adjusted for a pro rata issue of shares, a bonus issue or capital reorganization. The Warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant.

In addition to the above cash financing from Ridgeback, it was disclosed at the Extraordinary General Meeting explanatory memorandum that Ridgeback also provides the company with additional benefits, including:

 

    Introductions to other well respected investment institutions which will help in future financing

 

    The ability to attract other top level executives and researchers to the company and the board

 

    Potential introductions for additional in-licensing opportunities; and

 

    Increased visibility to other biotechnology and pharmaceutical companies and potential partners and collaborators on Prima’s internal assets

As a result of the above, the additional benefits provided to Prima determine that the financing transaction, including the issue of warrants, is to be accounted for as a Share-Based Payment and are expensed on the grant date in accordance with AASB 2 (IFRS 2). The value of the share-based payment to the strategic investor has been calculated by determining the fair value of the convertible note and warrants at the time of EGM approval and deducting the net cash proceeds from Ridgeback.

 

F-30


Table of Contents

NOTE 15. NON CURRENT LIABILITES – CONVERTIBLE NOTE (continued)

 

     June 30, 2016
A$
 

Fair value of convertible note

     45,851,305   

Fair value of warrants

     15,367,594   

Less: cash received

     (13,750,828
  

 

 

 

Share based payment to strategic investor

     47,468,071   
  

 

 

 

(i) Fair value of convertible notes

The initial fair value of the convertible notes has been estimated by an external valuer using a combination of the Black-Scholes methodology for the conversion option component of the notes and a discounted cashflow valuation for the debt component of the note. Key terms of the note are included above. The following assumptions which were based on market conditions that existed at the grant date:

 

Assumption

   Convertible
notes
    

Rationale

Historic volatility

     85.0%       Based on the Company’s historical volatility data

Share price re

   $ 0.051       Closing market share price on 31 July 2015

Risk free interest rate

     2.734%       Based on Australian Government securities yields which match the term of the convertible note

Risk adjusted interest rate

     15.0%       An estimate of the expected interest rate of a similar non-convertible note issued by the company

Dividend yield

     0.0%       Based on the Company’s nil dividend history

Risk free rate

     2.734%       Based on 10 year Australian Government securities yield

The fair value of the convertible note is allocated between a financial liability for the traditional note component of the convertible note and into equity which represents the conversion feature. The traditional note component of the convertible note was initially recorded at fair value of $4.4m, based on the present value of the contractual cash flows of the note discounted at 15%. After initial recognition, the liability component of the convertible note has been measured at fair value as required by AASB 2 (IFRS 2). The remaining value of the convertible note was allocated to the conversion feature and recognized as equity.

 

     Note – Liability      Conversion
feature – Equity
 

Fair value at issuance

     4,419,531         41,431,774   

Fair value movements

     607,637         —     
  

 

 

    

 

 

 

Balance at 30 June 2016

     5,027,168         41,431,774   
  

 

 

    

 

 

 

(ii) Fair value of warrants

The fair value of each warrant granted is not traded in an active market and instead has been estimated by an external valuer using the Black-Scholes pricing model based on the following assumptions. Key terms of the warrants were included above. The following assumptions were based on market conditions that existed at the grant date:

 

Assumption

   5 year
warrants
     10 year
warrants
    

Rationale

Historic volatility

     85.0%         85.0%       Based on 3 year historical volatility data for the Company

Exercise price

   $ 0.0237       $ 0.0250       As per subscription agreement

Share price

   $ 0.0510       $ 0.0510       Closing share price on valuation date from external market source

Risk-free interest rate

     2.177%         2.886%       Based on Australian Government securities yields which match the term of the warrant

Dividend yield

     0.0%         0.0%       Based on the Company’s nil dividend history

Fair value

   $ 0.0457       $ 0.0403       Determined using Black-Scholes models with the inputs above

 

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Table of Contents

NOTE 16. EMPLOYEE BENEFITS

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Annual leave

     27,694         80,304   
  

 

 

    

 

 

 

The current provision for employee benefits is in relation to accrued annual leave and covers all unconditional entitlements where employees have completed the required period of service. The entire amount of the provision is presented as current, since the group does not have an unconditional right to defer settlement for any of these obligations.

NOTE 17. EMPLOYEE BENEFITS

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Long service leave

     43,151         35,706   
  

 

 

    

 

 

 

NOTE 18. CONTRIBUTED EQUITY

 

          Consolidated  
    

Note

   June 30, 2016
A$
     June 30, 2015
A$
 

Fully paid ordinary shares

   18(a)      184,868,978         170,216,482   

Options over ordinary shares

        9,661,954         9,661,954   
     

 

 

    

 

 

 
        194,530,932         179,878,436   
     

 

 

    

 

 

 

(a) Ordinary Shares

 

          June 30, 2016      June 30, 2015  
    

Note

   No.      A$      No.      A$  

At the beginning of reporting period

        1,751,494,601         170,216,482         1,228,709,341         139,352,418   

Shares issued during year

   18(b)      283,158,931         13,761,075         284,274,073         7,365,369   

Exercise of options and warrants (Shares issued during the year)

   18(b)      26,977,412         1,174,567         72,413,924         3,731,339   

Exercise of convertible notes (Shares issued during the year)

   18(b)      —           —           166,097,263         19,931,672   

Transaction costs relating to share issues

        —           (283,146      —           (164,316
     

 

 

    

 

 

    

 

 

    

 

 

 

At reporting date

        2,061,630,944         184,868,978         1,751,494,601         170,216,482   
     

 

 

    

 

 

    

 

 

    

 

 

 

(b) Shares issued

 

2016 Details

   Number      Issue Price
A$
     Total
A$
 

Shares issued under Share Purchase Plan

     200,000,000         0.05         10,000,000   

Ridgeback shares issued

     12,136,750         0.02         209,966   

Share placement

     31,022,181         0.05         1,551,109   

Share placement

     40,000,000         0.05         2,000,000   

Performance rights exercised

     26,977,409         0.04         1,174,566   

Options exercised

     3         0.20         1   
  

 

 

       

 

 

 
     310,136,343            14,935,642   
  

 

 

       

 

 

 

 

F-32


Table of Contents

NOTE 18. CONTRIBUTED EQUITY (continued)

 

2015 Details

   Number      Issue Price
A$
     Total
A$
 

Bergen commencement fee

     11,792,588         0.04         483,496   

Bergen collateral shares

     17,800,000         0.02         338,200   

Bergen first tranche

     13,163,514         0.04         526,541   

Performance right exercised

     1,715,686         0.04         63,480   

Bergen second tranche

     15,214,606         0.03         517,297   

Consideration buyer shares to Immutep stakeholders

     86,120,815         0.03         2,593,959   

Bergen third tranche

     15,323,414         0.03         505,674   

Bergen fourth tranche

     22,936,950         0.02         527,550   

Ridgeback share issued

     28,000,000         0.02         560,000   

Ridgeback first placement

     72,206,500         0.02         1,249,172   

Bergen option exercised

     19,800,000         0.05         1,084,050   

Conversion of Warrants – Immutep

     52,371,500         0.05         2,628,525   

Employee option exercised

     242,424         0.08         18,764   

Exercise of convertible note

     166,097,263         0.12         19,931,672   
  

 

 

       

 

 

 
     522,785,260            31,028,380   
  

 

 

       

 

 

 

In October 2014, Prima entered into an investment agreement with the Bergen Global Opportunity Fund, LP (Bergen). Under the agreement, Bergen subscribed to a 36-month interest-free convertible security in the amount of $2,833,000, expiring on 2 October 2017. In addition, Bergen could invest in the range of $438k (US$360k) and $1.8m (US$1.5m) per month in monthly tranches, dependent on meeting certain conditions. Bergen was also issued 19,800,000 options and was issued with 17,800,000 shares as security over the investment agreement.

The investment agreement with Bergen concluded in May 2015 and was formally terminated in August 2015. Upon the conclusion of the investment agreement, Bergen exercised their options, and convertible note as detailed above.

Finance costs relating to the Bergen investment agreement was $18,338,015 for the year ended 30 June 2015. The finance costs incurred relate to the following terms of the Bergen agreement.

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Commencement fee

     —           483,496   

Discount to fair value of tranche funding

     —           211,124   

Share based payment expense related to collateral shares

     —           151,264   

Share based payment expense related to options

     —           414,342   

Discount to fair value on exercise of convertible notes to ordinary shares

     —           17,077,789   
  

 

 

    

 

 

 
     —           18,338,015   
  

 

 

    

 

 

 

 

  1) The convertible note issued to Bergen was recorded on issuance date as a financial liability and then re-measured at fair value through the profit and loss in accordance with AASB 139 (IAS 39). Under the Agreement the conversion price was calculated based on the average of any five daily VWAP’s per share during twenty consecutive actual trading days immediately prior to the selected conversion date, at the discretion of Bergen. The conversion price was calculated at $0.0190 per share and the calculated number of shares issued to Bergen was 166,097,263. The market price on the day that the shares were issued to Bergen was $0.12 per share resulting in a fair value re-measurement loss of $17,077,789 being recorded.

 

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Table of Contents

NOTE 18. CONTRIBUTED EQUITY (continued)

 

2014 Details

  

Note

   Number      Issue Price
A$
     Total
A$
 

Share purchase plan

   i)      85,562,500         0.080         6,845,000   

Exercise of PRRO options

   ii)      3         0.200         1   

Transaction costs relating to share issues

              (157,606
     

 

 

       

 

 

 
        85,562,503            6,687,395   
     

 

 

       

 

 

 

Ordinary shares

Ordinary shares entitle the holder to participate in dividends and the proceeds on the winding up of the company in proportion to the number of and amounts paid on the shares held. The fully paid ordinary shares have no par value and the company does not have a limited amount of authorized capital.

The fully paid ordinary shares have no par value and the company does not have a limited amount of authorized capital.

On a show of hands every member present at a meeting in person or by proxy shall have one vote and upon a poll each share shall have one vote.

Options

Information relating to the Company’s Global Employee Share Option Plan, including details of options issued, exercised and lapsed during the financial year and options outstanding at the end of the reporting period, is set out in note 31.

Unlisted Options

 

Expiration Date

   Exercise Price      Number  

June 30, 2018

   $ 0.0774         1,680,868   

December 12, 2018

   $ 0.05019         147,628,500   

August 4, 2020

   $ 0.0237         371,445,231   

October 30, 2020

   $ 0.057         793,103   

March 7, 2021

   $ 0.04         1,026,272   

August 4, 2025

   $ 0.025         8,475,995   
     

 

 

 

Total

        531,049,969   
     

 

 

 

Share buy-back

There is no current on-market share buy-back.

Capital risk management

The consolidated entity’s objectives when managing capital are to safeguard its ability to continue as a going concern, so that they can continue to provide returns for shareholders and benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital .

In order to maintain or adjust the capital structure, the consolidated entity may adjust the amount of dividends paid to shareholders, return capital to shareholders, issue new shares or sell assets to reduce debt.

The consolidated entity would look to raise capital when an opportunity to invest in a business or company was seen as value adding relative to the current parent entity’s share price at the time of the investment. The consolidated entity is not actively pursuing additional investments in the short term as it continues to integrate and grow its existing businesses in order to maximize synergies.

 

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Table of Contents

NOTE 19. EQUITY – RESERVES AND RETAINED EARNINGS

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

(a) Reserves

     

Options issued reserve

     19,116,205         3,748,611   

Conversion feature of convertible note reserve

     41,431,774         —     

Foreign currency translation reserve

     38,945         (268,052

Share-based payment reserve

     2,671,263         1,787,170   
  

 

 

    

 

 

 
     63,258,187         5,267,729   
  

 

 

    

 

 

 

Movement in options issued reserve were as follows:

     

Opening balance

     3,748,611         1,547,574   

Options issued during the year

     15,367,594      2,201,037   
  

 

 

    

 

 

 

Ending balance

     19,116,205         3,748,611   
  

 

 

    

 

 

 

Movements in conversion feature of convertible note reserve:

     

Opening balance

     —           —     

Conversion feature of convertible note

     41,431,774      —     
  

 

 

    

 

 

 

Ending balance

     41,431,774         —     
  

 

 

    

 

 

 

Movement in foreign currency translation reserve were as follows:

     

Opening balance

     (268,052      (211,145

Currency translation differences arising during the year

     306,997         (56,907
  

 

 

    

 

 

 

Ending balance

     38,945         (268,052
  

 

 

    

 

 

 

Movement in share-based payment reserve were as follows:

     

Opening balance

     1,787,170         546,245   

Employee options issued during the year

     1,976,417         738,799   

Exercise of vested performance rights

     (1,174,566      (63,480

Share-based payments

     82,242         565,606   
  

 

 

    

 

 

 

Ending balance

     2,671,263         1,787,170   
  

 

 

    

 

 

 

(b) Accumulated losses

     

Movement in accumulated losses were as follows:

     

Opening balance

     (160,456,422      (128,304,726

Net loss for the year

     (62,015,184      (32,151,696
  

 

 

    

 

 

 

Balance

     (222,471,606      (160,456,422
  

 

 

    

 

 

 

 

* Current year movements relate to the fair value of convertible notes and warrants issued to Ridgeback accounted for in accordance with AASB 2 (IFRS 2). Refer to note 15 for further information.

(c) Nature and purpose of reserves

(i) Options issued reserve

On 4 August 2015 warrants were granted to Ridgeback Capital Investments. 8,475,995 Warrants were granted which are exercisable at a price of $0.025 per share on or before 4 August 2025. 371,445,231 Warrants were granted which are exercisable at a price of $0.0237 per share on or before 4 August 2020. All warrants may be settled on a gross or net basis and the number of warrants or exercise price may be adjusted for a pro rata issue of shares, a bonus issue or capital reorganisation. The Warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. For further information, refer to note 15.

In October 2014, the Company issued 19,800,000 options with an exercise price of $0.05475 in relation to the Bergen investment agreement. In December 2014, the Company issued 200,000,000 warrants at an exercise price of $0.05019 to the vendors of Immutep S.A. The options expire on 2 October 2017 and 12 December 2018. Each option and warrant is exercisable for one ordinary share in the capital of the Company. As at 30 June 2015, all options held by Bergen were exercised, and 52,371,500 warrants were exercised by the vendors of Immutep S.A. The options held are exercisable at any time before its expiry date.

 

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NOTE 19. EQUITY – RESERVES AND RETAINED EARNINGS (continued)

 

(ii) Conversion feature of convertible note reserve

This amount relates to the conversion feature of the convertible note issued to Ridgeback Capital Investments which has been measured at fair value as required by AASB 2 (IFRS 2). For further information, refer to note 15.

(iii) Foreign currency translation reserve

Exchange differences arising on translation of the foreign controlled entity a recognized in other comprehensive loss as described in note 1(d) and accumulated in a separate reserve within equity. The cumulative amount is reclassified to profit or loss when the net investment is disposed of.

(iv) Share-based payments reserve

The share-based payments reserve is used to recognize the grant date fair value of options and performance rights issued to employees but not exercised. For a reconciliation of movements in the share-based payment reserves refer to note 31.

NOTE 20. DIVIDENDS

There were no dividends paid or declared during the current or previous financial year.

NOTE 21. BUSINESS COMBINATION

(a) Summary of prior year’s acquisition

Acquisition of Immutep S.A.

On 12 December 2014, the Group acquired 100% of the issued share capital of Immutep S.A., a French biopharmaceutical company in the field of Immuno-Oncology, for consideration of $26,275,569. The acquisition has significantly increased the portfolio of Immuno-Oncology technologies for further clinical development.

There have been no changes to the provisionally determined fair values of assets and liabilities recognised as a result of the acquisition in the previous financial year.

(b) Net cash outflow for prior years‘ acquisition

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Outflow of cash to acquire subsidiary, net of cash acquired

     

Cash consideration*

     —           21,458,107   

Less: Balance acquired cash

     —           (545,195
  

 

 

    

 

 

 
     —           20,912,912   
  

 

 

    

 

 

 

 

* The total cash paid during the year ended 30 June 2015 in relation to the acquisition of Immutep S.A. was $21,458,107.

(c) Comparability milestone

As part of the acquisition of Immutep S.A in the previous financial year, an amount of $1,084,149 was paid into a retention account and it was determined that there was a 50% likelihood that a comparability study was required. The fair value of the amount refundable on acquisition was $542,075 and as such the cash paid in relation to the purchase consideration was reduced by this amount. As the refundable consideration was contingent on an uncertain future event, it was recognized as a financial asset at fair value in accordance with AASB 3 (IFRS 3) on acquisition. During the year, the comparability study was not required, and was subsequently measured at fair value through profit or loss in accordance with AASB 3 (IFRS 3). Accordingly the $542,075 was recognized as an expense for the year ended 30 June 2016.

 

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NOTE 22. KEY MANAGEMENT PERSONNEL DISCLOSURES

(a) Directors and key management personnel compensation

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Short-term employee benefits

     1,300,140         1,509,877         1,533,114   

Long-term employee benefits

     5,817         6,231         —     

Post-employment benefits

     42,471         43,056         40,377   

Share-based payments

     1,824,643         467,002         41,919   
  

 

 

    

 

 

    

 

 

 
     3,173,071         2,026,166         1,615,410   
  

 

 

    

 

 

    

 

 

 

(b) Equity instrument disclosures relating to key management personnel

(i) Options provided as remuneration and shares issued on exercise of such options

For details of options provided as remuneration and shares issued on the exercise of such options, together with terms and conditions of the options, please refer to note 31.

(ii) Shareholding

The numbers of shares in the company held during the financial year by each director of and other key management personnel of the group, including their personally related parties, are set out below. There were no shares granted during the reporting period as compensation.

 

June 30, 2016

   Balance at
start of the year
     Received during the
year on the exercise
of performance rights
     Received during
the year on the
exercise of
options
     Other changes
during the year
     Balance at end
of the year
 

Ordinary shares

              

Ms. Lucy Turnbull, AO

     20,059,576         —           —           300,000         20,359,576   

Mr. Albert Wong

     3,537,500         —           —           300,000         3,837,500   

Dr. Russell Howard

     —           —           —           —           —     

Mr. Pete Meyers

     1,715,686         2,573,529         —           —           4,289,215   

Mr. Marc Voigt

    

 

870,000

150

  

    

 

10,735,293

—  

  

  

    

 

—  

—  

  

  

    

 

—  

—  

  

  

    

 

11,605,293

150

  

Ms. Deanne Miller

     20,924         6,450,980         —           (1,520,924      4,950,980   

Dr. Frédéric Triebel

     9,311,383         3,333,333         —           —           12,644,716   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total ordinary shares

     35,515,219         23,093,135         —           (920,924      57,687,430   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total ADR

     150         —           —           —           150   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

* American Depositary Receipts (ADR) traded on the NASDAQ

 

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NOTE 22. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)

 

June 30, 2015

   Balance at
start of the year
    Received during
the year on the
exercise of
performance
rights
     Received during
the year on the
exercise of
options
     Other changes during
the year
    Balance at end
of the year
 

Ordinary shares

            

Ms. Lucy Turnbull, AO

     20,059,576        —           —           —          20,059,576   

Mr. Albert Wong

     3,537,500        —           —           —          3,537,500   

Dr. Russell Howard

     —          —           —           —          —     

Mr. Pete Meyers

     —          1,715,686         —           —          1,715,686   

Mr. Matt Lehman

    

 

1,617,763

32,706

  

    —           —           —         

 

1,617,763

32,706

  

Dr. Sharron Gargosky

     —          —           —           —          —     

Mr. Marc Voigt

    

 

720,000

150

  

    —           —          

 

150,000

—  

  

  

   

 

870,000

150

  

Ms. Deanne Miller

     —          —           242,424         (221,500     20,924   

Dr. Frédéric Triebel

     —          —           —           9,311,383        9,311,383   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total ordinary shares

     25,934,839        1,715,686         242,424         9,239,883        37,132,832   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total ADR

     32,856        —           —           —          32,856   
  

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

 

* American Depositary Receipts (ADR) traded on the NASDAQ

 

June 30, 2014

   Balance at
start of the year
    Received during
the year on the
exercise of
options
     Other changes
during the
year
    Balance at end
of the year
 

Ordinary shares

         

Ms. Lucy Turnbull, AO

     17,759,576        —           2,300,000        20,059,576   

Mr. Albert Wong

     3,537,500        —           —          3,537,500   

Mr. Martin Rogers**

     20,542,179        —           —          20,542,179   

Dr. Richard Hammel**

     10,444,987        —           —          10,444,987   

Dr. Russell Howard

     —          —           —          —     

Mr. Pete Meyers

     —          —           —          —     

Mr. Matt Lehman

    

 

1,617,763

4,400

  

   

 

—  

—  

  

  

    

 

—  

28,306

  

   

 

1,617,763

32,706

  

Dr. Sharron Gargosky

     25,000     —           (25,000     —     

Mr. Marc Voigt

    

 

620,000

150

  

   

 

—  

—  

  

  

    

 

100,000

—  

  

  

   

 

720,000

150

  

  

 

 

   

 

 

    

 

 

   

 

 

 

Total ordinary shares

     54,522,005        —           2,400,000        56,922,005   
  

 

 

   

 

 

    

 

 

   

 

 

 

Total ADR

     29,550        —           3,306        32,856   
  

 

 

   

 

 

    

 

 

   

 

 

 

 

* American Depositary Receipts (ADR) traded on the NASDAQ
** As the date of resignation

 

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NOTE 22. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)

 

(iii) Option holdings

The number of options over ordinary shares in the parent entity held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below:

 

June 30, 2016

   Balance at
start of
the year
     Granted      Exercised      Other
Changes
    Balance at
end
of the year
     Vested and
exercisable
     Unvested  

Options over ordinary shares

                   

Ms. Lucy Turnbull, AO

     4,439,894         —           —           —          4,439,894         4,439,894         —     

Mr. Albert Wong

     —           —           —           —          —           —           —     

Dr. Russell Howard

     —           —           —           —          —           —           —     

Mr. Pete Meyers

     —           —           —           —          —           —           —     

Mr. Marc Voigt

     1,171,754         —           —           (450,000     721,754         721,754         —     

Ms. Deanne Miller

     121,212         —           —           —          121,212         121,212         —     

Dr Frédéric Triebel

     24,000,600         —           —           —          24,000,600         24,000,600         —     
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
     29,733,460         —           —           (450,000     29,283,460         29,283,460         —     
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

 

June 30, 2015

   Balance at
start of
the year
     Granted      Exercised     Other
Changes
     Balance at
end
of the year
     Vested and
exercisable
     Unvested  

Options over ordinary shares

                   

Ms. Lucy Turnbull, AO

     4,439,894         —           —          —           4,439,894         4,439,894         —     

Mr. Albert Wong

     —           —           —          —           —           —           —     

Mr. Martin Rogers

     —           —           —          —           —           —           —     

Dr. Russell Howard

     —           —           —          —           —           —           —     

Mr. Pete Meyers

     —           —           —          —           —           —           —     

Mr. Matt Lehman

     2,104,441         —           —          —           2,104,441         2,104,441         —     

Dr. Sharron Gargosky

     1,537,275         —           —          —           1,537,275         1,537,275         —     

Mr. Marc Voigt

     1,171,754         —           —          —           1,171,754         1,171,754         —     

Ms. Deanne Miller

     363,636         —           (242,424     —           121,212         121,212         —     

Dr Frédéric Triebel

     —           —           —          24,000,600         24,000,600         24,000,600         —     
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 
     9,617,000         —           (242,424     —           33,375,176         33,375,176         —     
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents

NOTE 22. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)

 

June 30, 2014

   Balance at
start of
the year
     Granted      Entitlement
options
     Other
Changes
    Balance at
end
of the year
     Vested and
exercisable
     Unvested  

Options over ordinary shares

                   

Ms. Lucy Turnbull, AO

     14,439,894         —           —           (10,000,000     4,439,894         4,439,894         —     

Mr. Albert Wong

     7,500,000         —           —           (7,500,000     —           —           —     

Mr. Martin Rogers

     12,500,000         —           —           (10,000,000     2,500,000         2,500,000         —     

Dr. Richard Hammel

     5,000,000         —           —           (5,000,000     —           —           —     

Dr. Russell Howard

     —           —           —           —          —           —           —     

Mr. Pete Meyers

     —           —           —           —          —           —           —     

Mr. Matt Lehman

     2,104,441         —           —           —          2,104,441         2,104,441         —     

Ms. Deanne Miller

     —           363,636        —           —          363,636         242,424         121,212   

Dr. Sharron Gargosky

     900,000         637,275        —           —          1,537,275         1,324,850         212,425   

Mr. Marc Voigt

     528,125         643,629        —           —          1,171,754         957,211         214,543   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 
     42,972,460         1,644,540        —           (32,500,000     12,117,000         11,568,820         548,180   
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

(iv) Performance rights holdings

The number of performance rights over ordinary shares in the parent entity held during the financial year by each director and other members of key management personnel of the consolidated entity, including their personally related parties, is set out below:

 

June 30, 2016

   Balance at
start of
the year
     Granted      Exercised     Other
Changes
     Balance at
end
of the year
     Vested and
exercisable
     Unvested  

Rights over ordinary shares

                   

Ms. Lucy Turnbull, AO

     —           —           —          —           —           —           —     

Mr. Albert Wong

     —           —           —          —           —           —           —     

Dr. Russell Howard

     —           —           —          —           —           —           —     

Mr. Pete Meyers

     6,004,902         —           (2,573,529     —           3,431,373         —           3,431,373   

Mr. Marc Voigt

     16,323,529         20,000,000         (10,735,293     —           25,588,235         —           25,588,236   

Ms. Deanne Miller

     6,127,451         12,000,000         (6,450,980     —           11,676,471         —           11,676,471   

Dr. Frédéric Triebel

     —           11,486,326         (3,333,333     —           8,152,993         —           8,152,993   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 
     28,455,882         43,486,326         (23,093,135     —           48,849,072         —           48,849,073   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

 

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NOTE 22. KEY MANAGEMENT PERSONNEL DISCLOSURES (continued)

 

June 30, 2015

   Balance at
start of
the year
     Granted      Exercised     Other
Changes
     Balance at
end
of the year
     Vested and
exercisable
     Unvested  

Rights over ordinary shares

                   

Ms. Lucy Turnbull, AO

     —           —           —          —           —           —           —     

Mr. Albert Wong

     —           —           —          —           —           —           —     

Dr. Russell Howard

     —           —           —          —           —           —           —     

Mr. Pete Meyers

     —           7,720,588         (1,715,686     —           6,004,902         —           6,004,902   

Mr. Matthew Lehman

     —           —           —          —           —           —           —     

Dr. Sharron Gargosky

     —           6,127,451         —          —           6,127,451         —           6,127,451   

Mr. Marc Voigt

     —           16,323,529         —          —           16,323,529         —           16,323,529   

Ms. Deanne Miller

     —           6,127,451         —          —           6,127,451         —           6,127,451   

Dr. Frédéric Triebel

     —           —           —          —           —           —           —     
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 
     —           36,299,019         (1,715,686     —           34,583,333         —           34,583,333   
  

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

    

 

 

 

NOTE 23. REMUNERATION OF AUDITORS

During the year the following fees were paid or payable for services provided by the auditor of the parent entity, its related practices and non-related audit firms

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Audit fees

PricewaterhouseCoopers Australia

        

Audit or review of the financial report

     232,000         286,000         209,420   

Other audit and assurance services in relation to regulatory filings overseas

     209,741         —           12,500  
  

 

 

    

 

 

    

 

 

 
     441,741         286,000         221,920   

Audit-related fees

        

Network firm of PricewaterhouseCoopers Australia

        

Due Diligence services

     —           66,986         —     
  

 

 

    

 

 

    

 

 

 

Non-PwC audit firm

        

Audit or review of the financial report

     —           —           —     

Preparation of the tax return and other consulting services

     —           —           —     
  

 

 

    

 

 

    

 

 

 
     —           —           —     
  

 

 

    

 

 

    

 

 

 
     441,741         352,986         221,920   
  

 

 

    

 

 

    

 

 

 

NOTE 24. CONTINGENT LIABILITIES

There were no material contingent liabilities in existence at June 30, 2016 and June 30, 2015.

NOTE 25. COMMITMENTS FOR EXPENDITURE

There were no material capital or leasing commitments at June 30, 2016 and June 30, 2015.

 

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Table of Contents

NOTE 26. RELATED PARTY TRANSACTIONS

Parent entity

Prima BioMed Ltd is the parent entity.

Subsidiaries

Interests in subsidiaries are set out in note 27.

Key management personnel

Disclosures relating to key management personnel are set out in note 22.

Receivable from and payable to related parties

There were no trade receivables from or trade payables due to related parties at the reporting date.

Loans to/from related parties

There were no loans to or from related parties at the reporting date.

NOTE 27. SUBSIDIARIES

The consolidated financial statements incorporate the assets, liabilities and results of the following subsidiaries in accordance with the accounting policy described in note 1:

 

    

 

   Equity holding  

Name of entity

   Country of
incorporation
   June 30, 2016
%
     June 30, 2015
%
 

Prima BioMed USA Inc

   United States      100.00         100.00   

PRR Middle East FZ LLC

   United Arab Emirates      100.00         100.00   

Prima BioMed GmbH

   Germany      100.00         100.00   

Prima Biomed Australia Pty Ltd

   Australia      100.00         100.00   

Prima Biomed IP Pty Ltd

   Australia      100.00         100.00   

Immutep S.A.S.

   France      100.00         100.00   

NOTE 28. EVENTS OCCURRING AFTER THE REPORTING DATE

No matter or circumstance has arisen since 30 June 2016 that has significantly affected, or may significantly affect the consolidated entity’s operations, the results of those operations or the consolidated entity’s state of affairs in future financial years.

 

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NOTE 29. RECONCILIATION OF LOSS AFTER INCOME TAX TO NET CASH USED IN OPERATING ACTIVITIES

 

     Consolidated  
     June 30, 2016
A$
    June 30, 2015
A$
    June 30, 2014
A$
 

Loss after income tax expense for the year

     (62,015,184     (32,151,696     (13,343,381

Adjustments for:

      

Depreciation and amortization

     1,993,093        1,341,202        446,360   

Add back share based payments

     2,058,659        738,799        57,309   

Non-cash share based payment to strategic investor

     47,468,071        —          —     

Changes in fair value of comparability milestone

     542,075        —          —     

Add back (gain)/loss on disposal of assets

     (18,493     5,160        —     

Add back Non-cash finance expenses

     —          18,338,015        —     

Unrealized gain on exchange through the profit and loss

     844,864        (1,039,537     (908,594

Change in operating assets and liabilities:

      

Decrease/(increase) in current receivables

     (394,922     5,958,640        4,071   

Decrease/(increase) in other operating assets

     324,983        350,970        297,320   

(Decrease)/increase in trade and other payables

     (1,491,882     (1,187,960     (816,276

Increase/(decrease) in employee benefits

     (45,165     (357     79,821   

(Decrease)/increase in derivative financial instruments

     —          —          (33,714 )

(Decrease)/increase in income tax payable

     712        3,849        (10,077

Decrease/(increase) in deferred tax liability

     (1,184,139     (144,064     —     
  

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (11,309,691     (7,786,979     (14,227,161
  

 

 

   

 

 

   

 

 

 

 

F-43


Table of Contents

NOTE 30. EARNINGS PER SHARE

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Loss after income tax

     (62,015,184      (32,151,696      (13,343,381
  

 

 

    

 

 

    

 

 

 

Loss after income tax attributable to the owners of Prima BioMed Ltd

     (62,015,184      (32,151,696      (13,343,381
  

 

 

    

 

 

    

 

 

 
     Number      Number      Number  

Weighted average number of ordinary shares used in calculating basic earnings per share

     2,236,250,813         1,591,116,220         1,439,768,245   
  

 

 

    

 

 

    

 

 

 

Weighted average number of ordinary shares used in calculating diluted earnings per share

     2,236,250,813         1,591,116,220         1,439,768,245   
  

 

 

    

 

 

    

 

 

 
     Cents      Cents      Cents  

Basic earnings per share

     (2.77      (2.02      (0.93

Diluted earnings per share

     (2.77      (2.02      (0.93

Information concerning other notes and options issued:

The following table summarizes the convertible notes, listed options and unlisted options that were not included in the calculation of weighted average number of ordinary shares because they are anti-dilutive for the periods presented.

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Listed options

     77,378,693         77,378,696         77,378,696   

Unlisted options

     531,049,969         164,894,609         16,942,441   

Convertible notes

     706,476,966         —           —     
  

 

 

    

 

 

    

 

 

 

NOTE 31. SHARE-BASED PAYMENTS

a) Executive Incentive Plan (EIP)

Equity incentives are granted under the Executive Incentive Plan (EIP) which was approved by shareholders at the 2012 Annual General Meeting. In light of our increasing operations globally the Board reviewed the Company’s incentive arrangements to ensure that it continued to retain and motivate key executives in a manner that is aligned with members’ interests. As a result of that review, an ‘umbrella’ EIP was adopted to which eligible executives are invited to apply for the grant of performance rights and/or options. Equity incentives granted in accordance with the EIP Rules are designed to provide meaningful remuneration opportunities and will reflect the importance of retaining a world-class management team. The Company endeavors to achieve simplicity and transparency in remuneration design, whilst also balancing competitive market practices in France, Germany, and Australia. The company grants Short Term Incentives (STIs) and Long Term Incentives (LTIs) under the EIP.

 

F-44


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

Set out below are summaries of all STI and LTI performance rights granted under the EIP:

 

2016

Grant date

   Fair
value
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Lapsed during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

September 19, 2014

     0.042         7,398,896         —           5,390,073         2,008,823         —           —     

September 19, 2014

     0.044         10,845,588         —           —           5,422,794         5,422,794         —     

September 19, 2014

     0.044         3,615,196         —           —           1,807,598         1,807,598         —     

November 14, 2014

     0.037         4,068,627         —           4,068,627         —           —           —     

November 14, 2014

     0.038         9,191,177         —           —           —           9,191,177         —     

November 14, 2014

     0.040         3,063,725         —           —           —           3,063,725         —     

August 5, 2015

     0.047         —           945,180         945,180         —           —           —     

August 5, 2015

     0.050         —           2,551,985         —           2,551,985         —           —     

August 5, 2015

     0.051         —           850,662         —           850,662         —           —     

August 5, 2015

     0.047         —           42,000,000         13,999,999         —           28,000,001         —     

October 1, 2015

     0.060         —           600,000         —           —           600,000         —     

October 1, 2015

     0.061         —           200,000         —           —           200,000         —     

December 29, 2015

     0.050         —           1,538,462         —           —           1,538,462         —     

March 7, 2016

     0.041         —           1,486,326         —           —           1,486,326         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

        38,183,209         50,172,615         24,403,879         12,641,862        51,310,083         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

2015

Grant date

   Fair
value
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Lapsed during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

September 19, 2014

     0.042         —           7,398,896         —           —           7,398,896         —     

September 19, 2014

     0.044         —           10,845,588         —           —           10,845,588         —     

September 19, 2014

     0.044         —           3,615,196         —           —           3,615,196         —     

November 14, 2014

     0.037         —           4,068,627         —           —           4,068,627         —     

November 14, 2014

     0.038         —           9,191,177         —           —           9,191,177         —     

November 14, 2014

     0.040         —           3,063,725         —           —           3,063,725         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

        —           38,183,209         —           —           38,183,209         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

The fair value at grant date for Short Term Incentive (STI) performance rights are determined using a Black-Scholes option pricing model that takes into account the exercise price, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.

The model inputs for STI performance rights granted during the year ended 30 June 2016 included:

 

Grant date

   5 August
2015
    29 December
2015
    7 March
2016
 

Share price at grant date

   $ 0.047      $ 0.050      $ 0.041   

Expected price volatility of the Company’s shares

     167     169     169

Expected dividend yield

     Nil        Nil        Nil   

Risk-free interest rate

     2.03     1.97     2.14

The model inputs for STI performance rights granted during the year ended 30 June 2015 included:

 

Grant date

   19 September
2014
    14 November
2014
 

Share price at grant date

   $ 0.047      $ 0.050   

Expected price volatility of the Company’s shares

     90     90

Expected dividend yield

     Nil        Nil   

Risk-free interest rate

     2.86     2.55

There were no performance rights granted in fiscal year 2014.

 

F-45


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

The fair value at grant date for 42,000,000 long term incentives issued on 5 August 2015 are determined using a Black Scholes option pricing model that takes into account the exercise price, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.

The model inputs for these performance rights granted included:

 

Grant date

     5 August 2015   

Measurement period

     5 August 2015 to 5 August 2017   

Share price at grant date

     $0.047   

Expected price volatility of the Company’s shares

     162

Expected dividend yield

     Nil   

Risk-free interest rate

     1.95

The fair value at grant date for long term incentives are determined using an “Up and in Call” Barrier Option Pricing Model.

The model inputs for performance rights granted during the year ended 30 June 2016 included:

 

Grant date

     5 August 2015         1 October 2015   

Measurement period – tranche 1

    
 
5 August 2015 to
2 October 2017
  
  
    
 
1 October 2015 to
2 October 2017
  
  

Measurement period – tranche 2

    
 
5 August 2015 to
2 October 2018
  
  
    
 
1 October 2015 to
2 October 2018
  
  

Barrier price

    

 
 
 

CAGR 20% per

annum over
measurement
period

  

  
  
  

    
 
 
 
CAGR 20% per
annum over
measurement
period
  
  
  
  

Share price at grant date

     $0.047         $0.058   

Expected price volatility of the Company’s shares

     120%         120%   

Expected dividend yield

     Nil         Nil   

Risk-free interest rate

     2.12%         1.94%   

The model inputs for performance rights granted during the year ended 30 June 2015 included:

 

Grant date

     19 September 2014         14 November 2014   

Measurement period – tranche 1

    
 
19 September 2014
to 2 October 2017
  
  
    
 
 
19 September
2014 to 2 October
2017
  
  
  

Measurement period – tranche 2

    
 
19 September 2014
to 2 October 2018
  
  
    
 
 
19 September
2014 to 2 October
2018
  
  
  

Barrier price

    
 
 
 
CAGR 20% per
annum over
measurement
period
  
  
  
  
    
 
 

 

CAGR 20% per
annum over
measurement

period

  
  
  

  

Share price at grant date

     $0.042         $0.037   

Expected price volatility of the Company’s shares

     90%         90%   

Expected dividend yield

     Nil         Nil   

Risk-free interest rate

     2.86%         2.55%   

 

F-46


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

Set out below are summaries of options granted under the EIP:

 

2016

Grant date

   Expiry date      Exercise
price
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Forfeited during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

December 23, 2013

     30 June 2018         0.0774         1,515,752         —           —           —           1,515,752         1,515,752   

January 24, 2014

     30 June 2018         0.0774         165,116         —           —           —           165,116         165,116   
        

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

           1,680,868         —           —           —           1,680,868         1,680,868   
        

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average exercise price

        0.0774                     0.0774      

 

2015

Grant date

   Expiry date      Exercise
price
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
    Forfeited during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

December 23, 2013

     30 June 2018         0.0774         1,758,176         —           (242,424 )     —           1,515,752         1,515,752   

January 24, 2014

     30 June 2018         0.0774         165,116         —           —          —           165,116         165,116   
        

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Total

           1,923,292         —           (242,424 )     —           1,680,868         1,680,868   
        

 

 

    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

 

Weighted average exercise price

        0.0774                    0.0774      

 

2014

Grant date

   Expiry date      Exercise
price
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Forfeited during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

December 23, 2013

     30 June 2018         0.0774         1,758,176         —           —           —           1,758,176         1,758,176   

January 24, 2014

     30 June 2018         0.0774         —              165,116         —           —           165,116         165,116   
        

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

           1,758,176         165,116         —           —           1,923,292         1,923,292   
        

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average exercise price

        0.0774                     0.0774      

No options expired during the periods covered by the above tables.

The weighted average share price at the date of exercise of options exercised during the year ended 30 June 2016 was $0.0774 (2015 – $0.0774). The weighted average remaining contractual life of share options outstanding at the end of the period was 4 years. Options vest in three equal tranches, 33.3% vested on December 31, 2013, 33.3% vested on June 30, 2014, and 33.3% to vest on June 30, 2015. Vesting is contingent upon the employee being continuously employed in good standing through the vesting period. The options are subject to accelerated vesting according to agreed terms in each person’s employment contract.

Fair value of options granted

No options were granted during the year ended June 30, 2016 (2015 Nil, 2014 165,116 options granted). The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.

 

F-47


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

The model inputs for options granted included:

 

Grant date

     23 December 2013         24 January 2014   

Exercise price

     $0.0774         $0.0774   

Expiry period

     36 months after vesting         36 months after vesting   

Share price at grant date

     $0.04         $0.05   

Expected price volatility of the Company’s shares

     112%         116%   

Expected dividend yield

     Nil         Nil   

Risk-free interest rate

     2.92%         2.81%   

The expected price volatility is based on the historic volatility (based on the remaining life of the options), adjusted for any expected changes to future volatility due to publicly available information.

(b) Global Employee Share Option Plan (GESOP)

The establishment of the GESOP Plan was approved by shareholders at the 2011 annual general meeting. The GESOP is designed to provide long-term incentives for employees excluding directors to deliver long-term shareholder returns. Under the plan, participants are granted options based on certain performance standards being met. Participation in the plan is at the board’s discretion and no individual has a contractual right to participate in the plan or to receive any guaranteed benefits.

Options granted under the plan carry no dividend or voting rights. When exercisable, each option is convertible into one ordinary share. The exercise price of options is based on the volume weighted average price at which the company’s shares are traded on the Australian Securities Exchange (ASX) during the seven days up to and including the date of the grant.

Set out below are summaries of options granted under the GESOP:

 

2016

Grant date

  Expiry date      Exercise
price
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Forfeited during
the year
Number
    Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

August 1, 2012

    1 August 2015         0.185         1,600,000         —           —           (1,600,000     —           —     

November 16, 2012

    1 August 2015         0.185         1,200,000         —           —           (1,200,000     —           —     

February 20, 2013

    20 February 2016         0.173         200,000         —           —           (200,000     —           —     
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Total

          3,000,000         —           —           (3,000,000 )     —           —     
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Weighted average exercised price

       0.184            —                —        

 

2015

Grant date

  Expiry date      Exercise
price
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Forfeited during
the year
Number
    Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

November 3, 2011

    3 November 2014         0.279         100,000         —           —           (100,000 )     —           —     

January 3, 2012

    3 January 2015         0.233         100,000         —           —           (100,000 )     —           —     

August 1, 2012

    1 August 2015         0.185         1,600,000         —           —           —          1,600,000         1,600,000   

November 16, 2012

    1 August 2015         0.185         1,200,000         —           —           —          1,200,000         1,200,000   

February 20, 2013

    20 February 2016         0.173         200,000         —           —           —          200,000         200,000   
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Total

          3,200,000         —           —           (200,000 )     3,000,000         3,000,000   
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Weighted average exercised price

       0.189            —                0.184      

 

2014

Grant date

   Expiry date      Exercise
price
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Forfeited during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

November 3, 2011

     3 November 2014         0.279         100,000         —           —           —           100,000         100,000   

January 3, 2012

     3 January 2015         0.233         100,000         —           —           —           100,000         100,000   

August 1, 2012

     1 August 2015         0.185         1,600,000         —           —           —           1,600,000         450,000   

November 16, 2012

     1 August 2015         0.185         1,200,000         —           —           —           1,200,000         —     

February 20, 2013

     20 February 2016         0.173         200,000         —           —           —           200,000         —     
        

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

           3,200,000         —           —           —           3,200,000         650,000   
        

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average exercised price

        0.189            —                 0.189      

 

F-48


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

All remaining options granted under the GESOP expired during the financial year and were forfeited as the exercise price as above the underlying share price.

There were no share options exercised during the year (2015 – $nil). The weighted average remaining contractual life of share options outstanding at the end of the period was Nil (2015 – 1 year). Options vested after a period of twelve months from the grant date.

Fair value of options granted

There were no options granted during the year ended 30 June 2016 (2015—   Nil). The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.

(c) Employee Share Option Plan (ESOP)

The establishment of the ESOP Plan was approved by shareholders on April 30, 2010. The company has ceased to issue options under the ESOP.

The ESOP was designed to provide long-term incentives for employees excluding directors to deliver long-term shareholder returns. Under the plan, participants were granted options based on certain performance standards being met. Participation in the plan was at the board’s discretion and no individual had a contractual right to participate in the plan or to receive any guaranteed benefits. Options under the ESOP vested on grant date.

Options granted under the ESOP carried no dividend or voting rights. Each options granted under the ESOP is convertible into one ordinary share. The exercise price of options granted under the ESOP is $0.10 per option. All options granted under the ESOP were forfeited in the prior year as the exercise price was above the underlying share price.

Set out below are summaries of options granted under the ESOP:

 

2015

Grant date

  Expiry date      Exercise
price
     Balance at
start of the
year
Number
     Granted
during the
year
Number
     Exercised
during the
year
Number
     Forfeited during
the year
Number
    Balance at
end of the
year
Number
     Vested and
exercisable at
end of the year
Number
 

August 26, 2011

    August 26, 2014         0.10         500,000         —           —           (500,000 )     —           —     
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Total

          500,000         —           —           (500,000 )     —           —     
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Weighted average exercised price

       0.10                    —           —     

 

2014

Grant date

  Expiry date      Exercise
price
     Balance at
start of the
year
Number
     Granted
during the
year
Number
     Exercised
during the
year
Number
     Forfeited during
the year
Number
     Balance at
end of the
year
Number
     Vested and
exercisable at
end of the year
Number
 

August 26, 2011

    August 26, 2014         0.10         500,000         —           —           —           500,000         500,000   
       

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

          500,000         —           —           —           500,000         500,000   
       

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Weighted average exercised price

       0.10                     0.10         0.10   

500,000 options expired during the financial year and were forfeited as the exercise price was above the underlying share price

Fair value of options granted

There were no options granted during the year ended 30 June 2016 (2015 – $nil). The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.

 

F-49


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

The expected price volatility is based on the historic volatility (based on the remaining life of the options), adjusted for any expected changes to future volatility due to publicly available information, where options are issued to employees of subsidiaries within the group.

d) Options issued to directors with shareholders’ approval

At the 2010 annual general meeting, shareholders approved the issue of 34,500,000 options to the directors. Options granted under the plan carry no dividend or voting rights. When exercisable, each option is convertible into one ordinary share. The exercise price of options is $0.20 for 32,500,000 and $0.10 for 2,000,000.

Set out below are summaries of options granted with shareholders approvals:

 

2015

Grant date

  Expiry date      Exercise
price
     Balance at
start of the
year
Number
     Granted
during
the
year
Number
     Exercised
during the
year
Number
     Lapsed during
the year
Number
    Balance at
end of the
year
Number
     Vested and
exercisable at
end of the year
Number
 

December 6, 2010*

    December 6, 2014         0.10         2,000,000         —           —           (2,000,000     —           —     
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Total

          2,000,000         —           —           (2,000,000     —           —     
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Weighted average exercised price

       0.10         0.10                 —           —     

 

* these options were issued to Neil Frazer and had a 4 year vesting period and were fully vested as at 30 June 2014 upon his termination of employment

 

2014

Grant date

  Expiry date      Exercise
price
     Balance at
start of the
year
Number
     Granted
during
the
year
Number
     Exercised
during the
year
Number
     Lapsed during
the year
Number
    Balance at
end of the
year
Number
     Vested and
exercisable at
end of the year
Number
 

December 6, 2010

    December 6, 2013         0.20         32,500,000         —           —           (32,500,000     —           —     

December 6, 2010*

    December 6, 2014         0.10         2,000,000         —           —           —          2,000,000         2,000,000   
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Total

          34,500,000         —           —           (32,500,000     2,000,000         2,000,000  
       

 

 

    

 

 

    

 

 

    

 

 

   

 

 

    

 

 

 

Weighted average exercised price

       0.194         0.194                 0.10         0.10   

 

* these options were issued to Neil Frazer and had a 4 year vesting period and were fully vested as at 30 June 2014 upon his termination of employment

All options granted were forfeited in the prior year as the exercise price was above the underlying share price.

(e) Performance rights issued to directors with shareholders approval

At the 2015 extraordinary general meeting, shareholders approved the issue of 20,000,000 performance rights to the directors. Performance rights granted under the plan carry no dividend or voting rights. When exercisable, each performance right is convertible into one ordinary share. The weighted average remaining contractual life of performance rights outstanding at the end of the period was less than 1.1 years (2015 – 1.8 years).

Set out below are summaries of performance rights granted with shareholders approval.

 

2016

Grant date

   Fair value      Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Lapsed during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

November 14, 2014

     0.037         6,004,902         —           2,573,529         —           3,431,373         —     

November 14, 2014

     0.037         4,068,627         —           4,068,627         —           4,068,627         —     

November 14, 2014

     0.038         9,191,177         —           —           —           9,191,177         —     

November 14, 2014

     0.040         3,063,725         —           —           —           3,063,725         —     

August 5, 2015

     0.047         —           20,000,000         6,666,666         —           13,333,334         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

        22,328,431         20,000,000         13,308,822         —           29,019,609         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

F-50


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

2015

Grant date

   Fair
value
     Balance at
start of the
year Number
     Granted
during the
year Number
     Exercised
during the
year Number
     Lapsed during
the year
Number
     Balance at
end of the
year Number
     Vested and
exercisable at
end of the year
Number
 

November 14, 2014

     0.037         —           7,720,588         1,715,686         —           6,004,902         —     

November 14, 2014

     0.037         —           4,068,627         —           —           4,068,627         —     

November 14, 2014

     0.038         —           9,191,177         —           —           9,191,177         —     

November 14, 2014

     0.040         —           3,063,725         —           —           3,063,725         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

        —           24,044,117         1,715,686         —           22,328,431         —     
     

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Fair value of performance rights granted

The fair value at grant date for Short Term Incentive performance rights is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the performance right. The fair value at grant date for Long Term Incentive performance rights is determined using an “Up and in Call” Barrier Option Pricing Model.

(f) Options issued to other parties

During the year, options were issued to Ridgeback Capital Investments and Trout Group LLC.

Set out below is a summary of the options granted to both parties

 

2016

Grant date

  Expiry date   Exercise
price
    Balance at
start of the
year
Number
    Granted
during the
year
Number
     Exercised
during the
year
Number
    Lapsed during
the year
Number
    Balance at
end of the
year
Number
    Vested and
exercisable at
end of the year
Number
 

July 31, 2015....

  August 5, 2020     0.0237        —          371,445,231         —          —          371,445,231        371,445,231   

July 31, 2015..

  August 5, 2021     0.025        —          8,475,995         —          —          8,475,995        8,475,995   

October 30, 2015....

  October 30, 2020     0.057        —          793,103         —          —          793,103        793,103   

March 7, 2016....

  March 7, 2021     0.040        —          1,026,272         —          —          1,026,272        1,026,272   

 

F-51


Table of Contents

NOTE 31. SHARE-BASED PAYMENTS (continued)

 

Fair value of options granted

There were 381,739,601 options granted during the year ended 30 June 2016 (2015 – $nil). The fair value at grant date is determined using a Black-Scholes option pricing model that takes into account the exercise price, the term of the option, the impact of dilution, the share price at grant date and expected price volatility of the underlying share, the expected dividend yield and the risk free interest rate for the term of the option.

(g) Expenses arising from share-based payment transactions

Total expenses arising from share-based payment transactions recognized during the period as part of employee benefit expense were as follows:

 

     Consolidated  
     June 30, 2016
A$
     June 30, 2015
A$
 

Share-based payment expense

     82,242         565,606   

Employee share-based payment expense

     1,976,417         738,799   

Share Based Payment to strategic investor

     47,468,071         —     
  

 

 

    

 

 

 
     49,529,730         1,304,405   
  

 

 

    

 

 

 

Share-based payment transactions with employees are recognised during the period as a part of corporate administrative expenses.

 

F-52


Table of Contents

NOTE 32. PARENT ENTITY INFORMATION

Set out below is the supplementary information about the parent entity.

Statement of comprehensive loss

 

     Parent  
     June 30, 2016
A$
     June 30, 2015
A$
     June 30, 2014
A$
 

Loss after income tax

     (61,973,221      (29,484,263      (15,651,281

Total comprehensive loss

     (61,973,221      (29,484,263      (15,651,281

Statement of financial position

 

     Parent  
     June 30, 2016
A$
     June 30, 2015
A$
 

Total current assets

     20,205,467         6,103,198   

Total non current assets

     20,903,050         26,255,547   
  

 

 

    

 

 

 

Total assets

     41,108,517         32,358,745   
  

 

 

    

 

 

 

Total current liabilities

     1,103,005         1,848,136   

Total non current liabilities

     5,847,876         6,715,710   
  

 

 

    

 

 

 

Total liabilities

     6,950,881         8,563,846   
  

 

 

    

 

 

 

Equity

     

— Contributed equity

     194,530,932         179,878,437   

— Reserves

     63,219,244         5,535,781   

— Accumulated losses

     (223,592,540      (161,619,319
  

 

 

    

 

 

 

Total equity

     34,157,636         23,794,899   
  

 

 

    

 

 

 

Guarantees of financial support

There are no guarantees entered into by the parent entity.

Contingent liabilities of the parent entity

Refer to note 24 for details in relation to contingent liabilities as at June 30, 2016 and June 30, 2015.

Capital commitments – Property, plant and equipment

The parent entity did not have any capital commitments for property, plant and equipment at as June 30, 2016 and June 30, 2015.

 

F-53


Table of Contents

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 annual report on its behalf.

 

P RIMA B IOMED L TD
/s/ Marc Voigt

By: Marc Voigt

Title: Chief Executive Officer, Chief Financial

Officer and Chief Business Officer

Date: October 3, 2016


Table of Contents
ITEM 19. EXHIBITS

The following exhibits are filed as part of this Annual Report on Form 20-F:

EXHIBIT INDEX

 

          Incorporated by Reference  

Exhibit

  

Description

  

Schedule/
Form

    

File

Number

    

Exhibit

    

File

Date

 
  1.1    Constitution of Registrant      20-F         001-35428         1.1         2/13/12   
  2.1    Form of Deposit Agreement between Prima BioMed, The Bank of New York Mellon, as Depositary, and owners and holders from time to time of ADSs issued thereunder, including the Form of American Depositary Shares      20-F         001-35428         2.1         4/2/12   
  2.2    Subscription Agreement between Prima BioMed Ltd and Ridgeback Capital Investments L.P., dated May 14, 2015, as amended (including form warrants and notes)      20-F         001-35428         2.2         10/30/15   
  4.1    Deed of Novation between The MacFarlane Burnet Institute for Medical Research and Public Health Ltd, Prima BioMed and Cancer Vac Pty Ltd, dated April 18, 2012      20-F         001-35428         4.4.1         10/30/13   
  4.2+    Prima BioMed Employee Share Option Plan      20-F         001-35428         4.12         2/13/12   
  4.3+    Prima BioMed Global Employee Share Option Plan      20-F         001-35428         4.10         10/3/12   
  4.4+    Prima Executive Incentive Plan      20-F         001-35428         4.11         10/30/13   
  4.5+    Employment Agreement between Prima BioMed and Marc Voigt, effective July 1, 2012      20-F         001-35428         4.15         10/3/12   
  4.6+    Chief Executive Officer Employment Agreement between Prima BioMed and Marc Voigt, effective July 9, 2014      20-F         001-35428         4.15.1         9/24/14   
  4.7+    Executive and Business Manager Employment Contract between Prima Biomed GmbH and Marc Voigt, effective July 9, 2014      20-F         001-35428         4.15.2         9/24/14   
  4.8+    Variation to Executive Employment Agreement between Prima BioMed and Marc Voigt, effective June 1, 2015      20-F         001-35428         4.15.3         10/30/15   
  4.9#+    Second Variation to Executive Employment Agreement between Prima BioMed and Marc Voigt, effective September 8, 2016            
  4.10#+    Amendment to Executive and Business Manager Employment Contract between Prima Biomed GmbH and Marc Voigt, effective September 8, 2016            
  4.11+    Employment Agreement between Prima BioMed and Deanne Miller, dated October 13, 2012      20-F         001-35428         4.16         10/30/13   
  4.12+    Variation to Executive Employment Agreement between Prima BioMed and Deanne Miller, effective February 1, 2013      20-F         001-35428         4.16.1         10/30/13   
  4.13+    Variation to Executive Employment Agreement between Prima BioMed and Deanne Miller, effective June 1, 2015      20-F         001-35428         4.16.2         9/24/14   
  4.14*    Supply, Distribution and Licensing Agreement between Prima BioMed and Neopharm Ltd., dated February 19, 2014      20-F         001-35428         4.20         9/24/14   


Table of Contents
          Incorporated by Reference  

Exhibit

  

Description

  

Schedule/
Form

    

File

Number

    

Exhibit

    

File

Date

 
  4.15*    Share Sale Agreement, dated October 2, 2014, by and between Prima BioMed and Immutep S.A.      20-F         001-35428         4.21         10/30/15   
  4.16+    Amendment to the Indefinite Term Employment Contract Entered Into Effect On May 1st 2004, dated 1 October 2014, by and between Immutep S.A. and Frédéric Triebel      20-F         001-35428         4.22         10/30/15   
  4.17#+    Variation to the Amendment to the Indefinite Term Employment Contract, by and between Immutep S.A. and Frédéric Triebel, effective March 1, 2016            
  4.18#**    Sub-License, License and Asset Purchase Agreement, by and among Prima BioMed Ltd. and Sydys Corporation, dated May 12, 2016            
12.1#    Certification of Chief Executive Officer and Chief Financial Officer as required by Rule 13a-14(a) of the Securities Exchange Act of 1934            
13.1#    Certification of Chief Executive Officer and Chief Financial Officer as required by Rule 13a-14(b) of the Securities Exchange Act of 1934            

 

* Confidential treatment has been granted with respect to certain portions of this exhibit. Omitted portions have been submitted separately with the U.S. Securities and Exchange Commission.
** Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been submitted separately with the U.S. Securities and Exchange Commission.
+ Indicates management contract or compensatory plan.
# Filed herewith.

In accordance with SEC Release Nos. 33-8238 and 34-47986, Final Rule: Management’s Reports on Internal Control Over Financial Reporting and Certification of Disclosure in Exchange Act Periodic Reports, and the instructions to Form 20-F, the certifications furnished in Exhibits 13.1 and 13.2 hereto are deemed to accompany this Annual Report on Form 20-F and will not be deemed “filed” for purpose of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filing under the U.S. Securities Act of 1933, as amended, or the U.S. Securities Exchange Act of 1934, as amended, except to the extent that we specifically incorporates it by reference.

Exhibit 4.9

Mr Marc Voigt

Managing Director and Chief Executive Officer

Prima BioMed Limited

08 September 2016

Dear Marc,

Second Variation to Executive Employment Agreement dated 1 August 2014 as varied on 1 June 2015 (“Agreement”)

Further to our recent discussions, Prima BioMed Limited (“ Prima ”) agrees to vary your Agreement as set out in the attached Schedule.

This second variation is effective from 08 September 2016. Your new Remuneration will start being paid to you from next year (2017) on.

All other terms and conditions of your Agreement remain the same.

Please indicate your acceptance of this second variation by signing (in duplicate) this letter and returning one executed copy to me.

Prima looks forward to your ongoing assistance.

Yours faithfully

/s/ Lucy Turnbull

Lucy Turnbull AO

Chairman

Prima BioMed Ltd

 

I accept the variation to the Agreement

/s/ Marc Voigt

Marc Voigt


Schedule

Agreed amendments to Agreement

 

Clause

  

Agreed Amendment

Para 2,
clause 2
   Replace “3 years” with “6 years”
Para 3,

clause 2

  

Replace the whole wording of clause 2 with effect as from 1 January 2017 by the following wording:

 

As of 1 January 2017, Mr. Voigt shall receive by Prima Biomed GmbH in fulfilment of the payment obligation of Prima Biomed GmbH under the employment contract as managing director of Prima Biomed GmbH between Mr. Voigt and Prima Biomed GmbH the following salary:

 

An annual gross salary of € 215,000.00 (the “ Definite Salary ”) plus an additional contingent gross salary increase of € 35,000.00 per annum (the “ Increase Amount ”). However, the Increase Amount is contingent upon Mr. Voigt achieving a certain one time performance milestone as resolved by the shareholder of Prima Biomed GmbH (i.e. Prima BioMed Ltd.). The Increase Amount will be owed by Prima Biomed GmbH in full for the first time for such year, in which such performance milestone is achieved. The Definite Salary is payable by Prima Biomed GmbH in twelve even monthly instalments at the end of each month. In the year of the achievement of the performance milestone, a pro rata portion (months lapsed in such year, including month of milestone achievement / 12) of the Increase Amount will be due for payment at the end of the month in which the milestone was achieved; thereafter, in the remaining months of such year and in the following years of the term, the Increase Amount is payable in equal monthly instalments (Increase Amount / 12) together with the Definite Salary. Prima Biomed GmbH may further pay Mr. Voigt a discretionary cash bonus dependent on his performance.

 

-2-

Exhibit 4.10

 

 

AMENDMENT TO

THE EXECUTIVE- AND BUSINESS MANAGER EMPLOYMENT CONTRACT

 

 

between

Prima BioMed GmbH , Leipzig,

Local Court Leipzig HRB 27135

(the Company ”)

and

Marc Voigt

(the Managing Director ” or “ Mr. Voigt ”)

(the Company and the Managing Director hereinafter the Parties ” and each of them a Party ”)

8 September 2016

 

LOGO


Table of Contents

 

Table of Contents

     2   

Preliminary Remarks

     3   

§ 1 Amendments to the Managing Director Contract

     3   

§ 2 Final Provisions

     4   

List of Annexes

     5   

Signature Page(s)

     6   

 

- 2 -


Preliminary Remarks

 

A. The Managing Director already holds the office of managing director of the Company and has entered into an Executive- and Business Manager Employment Contract with the Company with effect from July 9 th , 2014 which is attached hereto as ANNEX A (the “ Managing Director Contract ”).

 

B. The Parties intent to make certain amendments the Managing Director Contract, in particular, but without limitation, it is intended to prolong the existing term by three full years and to contingently increase the Managing Director’s Salary from 1 January 2017 on.

NOW, THEREFORE, the Parties enter into the following agreement (the Agreement ”):

§ 1

Amendments to the Managing Director Contract

 

1.1 The Managing Director Contract shall be amended as follows:

 

  a) The term of the Managing Director Contract pursuant to Paragraph 2 shall be extended by additional three years, i.e. until the lapse of 8 July 2020.

 

  b) With effect as from, and including, 1 January 2017 the provision on the compensation contained in Paragraph 3, Section 1 shall be replaced by the following provision:

 

  “1. Mr. Voigt shall receive an annual gross salary of € 215,000.00 (the “ Definite Salary ”) plus an additional contingent gross salary increase of € 35,000 per annum (the “ Increase Amount ”). However, the Increase Amount is contingent upon Mr. Voigt achieving a certain one time performance milestone as resolved by the shareholder (i.e. Prima BioMed Ltd.) The Increase Amount will be owed by the Company in full for the first time for such year, in which such performance milestone is achieved. The Definite Salary is payable in twelve even monthly instalments at the end of each month. In the year of the achievement of the performance milestone, a pro rata portion (months lapsed in such year, including month of milestone achievement / 12) of the Increase Amount will be due for payment at the end of the month in which the milestone was achieved; thereafter, in the remaining months of such year and in the following years of the term, the Increase Amount is payable in equal monthly instalments (Increase Amount / 12) together with the Definite Salary. The Company may further pay Mr. Voigt a discretionary cash bonus dependent on his performance.”

 

1.2 All other provisions of the Managing Director Contract shall remain unaffected by this Agreement and in full force and effect.

 

- 3 -


§ 2

Final Provisions

 

2.1 Any provision of this Agreement may be amended or waived only if such amendment or waiver is by written instrument executed by the Parties and explicitly referring to this Agreement, unless a stricter form is required by law. The foregoing shall also apply with respect to a waiver of the requirement of the written form pursuant to this subsection.

 

2.2 Should any provision of this Agreement, or any provision incorporated into this Agreement in the future, be or become invalid or unenforceable, the validity or enforceability of the other provisions of this Agreement shall not be affected thereby. The invalid or unenforceable provision shall be deemed to be substituted by a suitable and equitable provision which, to the extent legally permissible, comes as close as possible to the economic intent and purpose of the invalid or unenforceable provision. The same shall apply: (i) if the Parties have, unintentionally, failed to address a certain matter in this Agreement; in this case a suitable and equitable provision shall be deemed to have been agreed upon which reflects what the Parties, in the light of the economic intent and purpose of this Agreement, would have agreed upon if they had considered the matter; or (ii) if any provision of this Agreement is invalid because of the scope of any time period or performance stipulated herein; in this case a legally permissible time period or performance shall be deemed to have been agreed upon which comes as close as possible to the stipulated time period or performance.

 

2.3 This Agreement shall be exclusively governed by the laws of the Federal Republic of Germany (without its choice of law provisions). The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

 

2.4 This contract is executed in the German and English languages. In the event of any inconsistencies, the English version shall prevail.

 

- 4 -


List of Annexes

 

Annex A    Executive- and Business Manager Employment Contract of July 9 th , 2014

 

- 5 -


Signature Page

 

For Prima BioMed GmbH    

/s/ Deanne Miller

   

/s/ Marc Voigt

Prima BioMed Ltd. as sole shareholder represented by Deanne Miller     Marc Voigt

 

- 6 -

Exhibit 4.17

 

  

LOGO

                                 Level 12, 95 Pitt Street

                                 Sydney

                                 NSW 2000

                                 Australia

Dr Frederic Triebel

Chief Scientific Officer and Chief Medical Officer

Prima BioMed Limited

C:/ - frederic.triebel@primabiomed.com.au

1 March 2016

Dear Frederic

Variation to Employment Agreement executed on 1 October 2014 (“Agreement”)

Further to our recent discussions, Prima BioMed Limited (“ Prima” ) agrees to vary your Agreement as set out in the attached Schedule.

This variation is effective from 1 March 2016. Your new Remuneration will start being paid to you from the next payroll run, with any back pay backdated to 1 March 2016 paid on this day as well.

All other terms and conditions of your Agreement remain the same.

Please indicate your acceptance of this variation by signing (in duplicate) this letter and returning one executed copy to me.

Prima looks forward to your ongoing assistance.

Yours faithfully,

 

LOGO

Marc Voigt,

CEO

Prima BioMed Ltd

 

I accept the variation to the Agreement

/s/ Frederic Triebel

Dr Frederic Triebel


Schedule

Agreed amendments to Agreement:

 

Clause

  

Agreed Amendment

4    Replace “Euros 160,000” with “Euros 170,000”

Exhibit 4.18

SUB-LICENSE, LICENSE AND

ASSET PURCHASE AGREEMENT

by and between

PRIMA BIOMED LTD

and

SYDYS CORPORATION

Dated as of 11 / 12 May 2016

 

Confidential treatment has been requested for redacted portions of this exhibit. This copy omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been provided separately to the Securities and Exchange Commission.

 

Certain schedules and annexes of this exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of the omitted schedules to the Securities and Exchange Commission upon request.


TABLE OF CONTENTS

 

ARTICLE I. DEFINITIONS      2
  SECTION 1.01.      Defined Terms .      2
  SECTION 1.02.      Interpretation and Rules of Construction .    11
ARTICLE II. GRANT OF SUB-LICENSE, PURCHASE AND SALE    12
  SECTION 2.01.      Grant of Sub-License.    12
  SECTION 2.02.      Know-How License.    12
  SECTION 2.03.      Purchase and Sale of Assets.    13
  SECTION 2.04.      Assumption and Exclusion of Liabilities.    14
  SECTION 2.05.      Non-Assignable Assets.    16
  SECTION 2.06.      Expense Consideration.    16
  SECTION 2.07.         19
  SECTION 2.08.      Obligation to found a subsidiary.    24
  SECTION 2.09.      Closing.    24
  SECTION 2.10.      Closing Deliveries by Seller.    24
  SECTION 2.11.      Closing Deliveries by Purchaser .    24
ARTICLE III. REPRESENTATIONS AND WARRANTIES OF SELLER    25
  SECTION 3.01.      Organization; Good Standing and Qualification; Authority and Binding Effect.    25
  SECTION 3.02.      No Conflict.    26
  SECTION 3.03.      Governmental Consents and Approvals.    26
  SECTION 3.04.      Litigation.    26
  SECTION 3.05.      Compliance with Laws.    27
  SECTION 3.06.      Intellectual Property.    27
  SECTION 3.07.      Title; Sufficiency of Assets.    28
  SECTION 3.08.      Taxes.    28
  SECTION 3.09.      No Brokers.    29
  SECTION 3.10.      Governmental Permits.    29
  SECTION 3.11.      Environmental Matters.    29
  SECTION 3.12.      Contracts.    29
  SECTION 3.13.      Full Disclosure.    30
  SECTION 3.14.      Purchase Entirely for Own Account.    30
  SECTION 3.15.      Disclosure of Information.    30
  SECTION 3.16.      Restricted Securities.    30
  SECTION 3.17.      Legends.    31
  SECTION 3.18.      Accredited Investor.    31
  SECTION 3.19.      No Other Representations or Warranties.    31
ARTICLE IV. REPRESENTATIONS AND WARRANTIES OF PURCHASER    31
  SECTION 4.01.      Organization and Authority of Purchaser.    31

 

ii


  SECTION 4.02.      No Conflict.    32
  SECTION 4.03.      Governmental Consents and Approvals.    32
  SECTION 4.04.      Litigation.    32
  SECTION 4.05.      No Brokers.    32
  SECTION 4.06.      Capitalization.    33
ARTICLE V. ADDITIONAL COVENANTS    33
  SECTION 5.01.      Confidentiality.    33
  SECTION 5.02.      Condition of the Purchased Assets.    34
  SECTION 5.03.      Bulk Transfer Laws.    34
  SECTION 5.04.      Further Action.    35
  SECTION 5.05.      Transfer of Books and Records.    35
  SECTION 5.06.      Seller’s Post-Closing Obligations with respect to Licensed IP.    35
  SECTION 5.07.      Patent Maintenance.    35
  SECTION 5.08.      Continuing Involvement.    36
  SECTION 5.09.      Stock.    36
  SECTION 5.10.      Transferred Books and Records.    36
  SECTION 5.11.      Noncompetition Agreement.    37
ARTICLE VI. PURCHASER OBLIGATION TO COMMERCIALISE    38
  SECTION 6.01.         38
  SECTION 6.02.         38
  SECTION 6.03.         38
ARTICLE VII. INDEMNIFICATION    39
  SECTION 7.01.      Survival of Representations and Warranties.    39
  SECTION 7.02.      Indemnification by Seller.    39
  SECTION 7.03.      Indemnification by Purchaser.    40
  SECTION 7.04.      Limits on Indemnification.    40
  SECTION 7.05.      Notice of Loss; Third Party Claims.    40
  SECTION 7.06.      Tax Treatment.    42
  SECTION 7.07.      Effect of Investigation.    42
  SECTION 7.08.      Remedies.    43
ARTICLE VIII. GENERAL PROVISIONS    43
  SECTION 8.01.      Expenses.    43
  SECTION 8.02.      Notices.    43
  SECTION 8.03.      Public Announcements.    45
  SECTION 8.04.      Severability.    45
  SECTION 8.05.      Entire Agreement.    45
  SECTION 8.06.      Assignment.    45
  SECTION 8.07.      Performance by Purchaser Related Parties.    46
  SECTION 8.08.      Amendment.    46
  SECTION 8.09.      Waiver.    46

 

iii


  SECTION 8.10.      Force Majeure.    46
  SECTION 8.11.      No Third Party Beneficiaries.    47
  SECTION 8.12.      Governing Law; Jurisdiction.    47
  SECTION 8.13.      Dispute Resolution.    47
  SECTION 8.14.      Counterparts.    49
  SECTION 8.15.      Construction; Headings.    49
  SECTION 8.16.      Specific Performance.    49

 

iv


EXHIBITS

 

A Form of Transfer Agreement

 

B CVAC Sub-License

 

C Know-How License

 

D New License

 

i


SUB-LICENSE, LICENSE AND

ASSET PURCHASE AGREEMENT

This Sub-License, License and Asset Purchase Agreement (this “ Agreement ”) is made and entered into as of 11/12 May 2016 (the “ Effective Date ”), by and among Prima Biomed Ltd ACN 009 237 889 (“ Seller ”), an Australian corporation listed on the Australian Securities Exchange and on the NASDAQ in the US, and Sydys Corporation, a Nevada corporation listed on the OTC Market under the symbol SYYC (“ Purchaser ”). Seller and Purchaser are herein referred to individually as a “ Party ” and collectively as the “ Parties .”

W I T N E S S E T H :

WHEREAS , Seller holds a worldwide exclusive license under certain patents and controls certain intellectual property and other assets related to CVac TM , a therapy based on ex vivo pulsing of dendritic cells or monocytes with the mannosylated fusion protein (“ CVAC ”) and has conducted research and development with respect to CVAC, which is applicable to a number of clinically important areas of cancer, including the treatment of ovarian cancer, and has the potential for the treatment of numerous other cancers including, lung, prostate, colorectal, breast, pancreatic, nasopharyngeal and renal.

WHEREAS , Seller is active in the field of oncology, more specifically in immuno oncology with biologicals and small molecules (“ Business of Seller ”).

WHEREAS , Seller does not have the permit to conduct clinical trials with respect to CVAC as Seller closed the past clinical trials and has not been applying for new clinical trials.

WHEREAS , Purchaser operates in the field of biotechnology and pharmaceutical drug development.

WHEREAS , Joseph Hernandez and Affiliates currently hold the simple majority of the shares in the Purchaser (the “ Shareholder ”).

WHEREAS , the Parties desire that, at the Closing, Seller shall grant an exclusive sub-license to Purchaser under the aforementioned license for CVAC, a non-exclusive Know-How License and sell and transfer to Purchaser, and Purchaser shall purchase from Seller, all of its remaining assets related to CVAC upon the terms and conditions set forth herein.

NOW, THEREFORE , in consideration of the foregoing and the representations, warranties, covenants and agreements contained herein, the Parties, intending to be legally bound, hereby agree as follows:

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


ARTICLE I.

DEFINITIONS

SECTION 1.01. Defined Terms .

As used in this Agreement, the following terms shall have the meanings set forth or as referenced below:

Action ” means any claim, cause of action, suit, arbitration, complaint, criminal prosecution, demand, summons, citation, notice of violation, governmental or other proceeding or investigation of any nature, civil, criminal, administrative, regulatory or otherwise, whether at law or equity, by or before any Governmental Authority.

Affiliate ” means, with respect to any specified Person, any other Person that directly, or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, such specified Person, provided that, for the purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

Agreement ” is defined in the Preamble.

Allocation Statement ” is defined in Section 5.05 .

Ancillary Agreements ” means the Transfer Agreement, the CVAC Sub-License, the Know-How License and the New License.

Asset Deal ” means a single or a series of transactions by which Purchaser disposes of all or a material portion of its assets or of all or a material portion of the assets relating to CVAC or the Covered Products.

Assumed Liabilities ” is defined in Section 2.04(a) .

Bankrupt ” means a party becoming subject to bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar Laws affecting creditors’ rights generally or by general principles of equity.

Burnet Institute ” means The Macfarlane Burnet Institute for Medical Research and Public Health Ltd ACN 007 349 984.

Business of Seller ” is defined in the Preamble.

Business Day ” means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Law to be closed in the City of New York.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


Calendar Quarter ” means, with respect to any Calendar Year, each of the three (3) consecutive calendar month periods ending on March 31, June 30, September 30 and December 31 of such Calendar Year.

Calendar Year ” means each period of twelve (12) consecutive calendar months beginning on January 1 and ending on December 31.

Cash and Cash Equivalents ” shall mean Seller’s cash, negotiable instruments, checks, money orders, marketable securities, short-term instruments and other cash equivalents, funds in time and demand deposits or similar accounts, and any evidence of indebtedness issued or guaranteed by any Governmental Authority, calculated in accordance with GAAP.

Closing ” is defined in Section 2.09 .

Closing Date ” is defined in Section 2.09 .

Code ” means the Internal Revenue Code of 1986, as amended.

Commercial Milestone Payment ” is defined in Section 2.07(b) .

Commercially Reasonable Efforts ” means, with respect to the Exploitation of Covered Products by Purchaser, that level of efforts and resources which would be used by a similar situated company with adequate funds for the purpose of Exploitation of the Covered Products for products at a similar stage of development and with similar market potential and market size and risk, taking into account efficacy, safety, competitiveness of alternative products in the marketplace, cost to develop, the anticipated or, if applicable, actual claim structure and the nature and extent of their market exclusivity (including patent coverage and regulatory exclusivity), the likelihood of obtaining Regulatory Approval, profitability (including the amounts of marketing and promotional expenditures with respect to the program), and all other relevant factors. Commercially Reasonable Efforts shall be determined on an aggregate basis with respect to all Covered Products and all markets.

Common Stock ” means the common stock, par value $1.05, of Purchaser.

Competitive Activity ” is defined in Section 5.11(b) .

Completion ” means, with respect to a Phase I Study, the last dosing of the last patient in such Phase I Study.

Confidential Information ” is defined in Section 5.01 .

Contingent Payments I ” is defined in Section 2.07(c) .

Contingent Payments II ” is defined Section 2.07(d) .

Contract ” means any written or oral note, bond, mortgage, indenture, guarantee, agreement, contract, sub-contract, lease, license or purchase order (which, for the avoidance of doubt, does not include any employee benefit or health or welfare plan or arrangement), and all amendments, modifications and supplements thereto.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


Control ” or “ Controlled ” means, with respect to any Intellectual Property, the possession (whether by ownership or license, other than pursuant to this Agreement) by a Party or its Affiliates of the ability to grant to the other Party access or a license as provided herein under such item or right without violating the terms of any agreement with any Third Party existing before or after the Effective Date.

Convertible Securities ” is defined in Section 1.01 .

Covered Product ” means any biologic, pharmaceutical or medical device product that contains CVAC (including the CVAC Products) or that is generated or derived from any of the Purchased Assets.

CVAC ” is defined in the Preamble.

CVAC Intellectual Property ” means Intellectual Property defined in the CVAC Sub-License which shall be sub-licensed to Purchaser at Closing.

CVAC Know How ” is defined in the Know-How License.

CVAC License ” means the license granted by the Burnet Institute to Seller under the Technology License Agreement.

CVAC Products ” means any formulation containing mannosylated fusion protein conjugated to mucin1; that has been pulsed ex vivo into a patients’ dendritic cells and then reinjected back into said patient, developed by or on behalf of Seller prior to the Effective Date.

CVAC Sub-License ” is defined in Section 2.01 .

CVAC Trademarks ” are defined in the Know-How License.

DBI-Development Agreement ” means the Development Agreement between Database Integrations Inc. and Seller dated 20 May 2015 as amended from time to time.

DBI-Revenue Report ” is defined in Section 2.07(d) .

DBI-Sub-Licensees ” means sub-licensees (and its affiliates) of the iCAN System (each as defined in the DBI-Development Agreement).

Development Milestone Event ” is defined in Section 2.07(a).

Development Milestone Payment ” is defined in Section 2.07(a) .

Direct Claim ” is defined in Section 7.05(a) .

Effective Date ” is defined in the introduction.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


Encumbrance ” means any security interest, pledge, attachment, easement, restriction, hypothecation, mortgage, lien (statutory or otherwise), option, conditional sale agreement, right of first refusal or right of first offer (including any agreement to give any of the foregoing), or encumbrance.

Environmental Law ” means all requirements of Laws derived from or relating to all federal, state and local laws or regulations relating to or addressing the environment, health or safety.

EU ” means all of the European Union member states as of the applicable time.

Excluded Assets ” is defined in Section 2.03(b) .

Excluded Liabilities ” is defined in Section 2.04(b) .

Exempt Securities ” means (i) Options or shares of restricted Common Stock subject to repurchase or forfeiture granted after the Closing Date to directors, officers or employees of, or consultants or advisors to, Purchaser or any of its subsidiaries pursuant to one or more plans, arrangements or agreements approved by the Board of Directors of Purchaser, provided that the number of shares of Common Stock for which such Options are exercisable plus shares of restricted Common Stock subject to repurchase or forfeiture do not exceed fifteen percent (15%) of the outstanding voting securities of Purchaser as of the date of computation (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization affecting such shares) and (ii) Common Stock, or securities exercisable for or convertible into Common Stock, issued pursuant to (a) the acquisition of another company or line of business by Purchaser by merger, purchase of substantially all of the assets or other reorganization or (b) any license agreement, collaboration agreement, joint venture agreement or other strategic relationship between Purchaser and a Third Party.

Expense Consideration ” is defined in Section 2.06(a) .

Exploitation ” means, as applicable, activities to research, develop, have developed, make, have made, register, use, sell, offer for sale, have sold, promote, have promoted, market, have marketed, distribute, have distributed, import or otherwise exploit a Covered Product. “ Exploit ” has a correlative meaning.

FDA ” means the United States Food and Drug Administration, or any successor agency or authority thereto.

FDCA ” means the United States Federal Food, Drug, and Cosmetic Act, as amended.

Financial Records ” is defined in Section 2.07(g)(iv) .

First Commercial Sale ” means, with respect to any Covered Product and any country in the Territory, the first sale of such Covered Product in such country by Purchaser or any Purchaser Related Party for monetary value for use or consumption by the general public pursuant to a Regulatory Approval in such country.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


Force Majeure ” is defined in Section 8.10 .

Fully-Diluted As-Converted Basis ” means incorporating and including (i) all issued and outstanding shares of Common Stock and (ii) all unissued shares of Common Stock that are either (x) issuable upon exercise of outstanding rights, options or warrants to subscribe for or otherwise acquire Common Stock or Convertible Securities (collectively, “ Options ”) or (y) issuable upon conversion or exchange of outstanding indebtedness, shares or other securities convertible into or exchangeable for Common Stock, other than Options and Exempt Securities (collectively, “ Convertible Securities ”).

Further Know-How ” is defined in the Know-How License.

GAAP ” means United States generally accepted accounting principles applied on a consistent basis.

Governmental Authority ” means any instrumentality, subdivision, court, tribunal, administrative agency, commission, official or other authority of any supranational, country, state, province, prefect, municipality, locality or other government or political subdivision thereof, or any quasi-governmental or private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority, or any arbitrator or arbitral body.

Governmental Order ” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.

Governmental Permits ” is defined in Section 3.10(a) .

IND ” means an Investigational New Drug application as defined in the FDCA and applicable regulations promulgated thereunder by the FDA, the filing of which is necessary to commence or conduct clinical testing of a Covered Product in humans in the United States.

Indemnified Party ” means a Purchaser Indemnified Party or a Seller Indemnified Party, as the case may be.

Indemnifying Party ” means Seller pursuant to Section 7.02 and Purchaser pursuant to Section 7.03 , as the case may be.

Indemnity Basket ” is defined in Section 7.04 .

Intellectual Property ” means any or all of the following and all rights therein, arising therefrom, or associated therewith: (i) all patents and applications therefor anywhere in the world (whether national, international or otherwise) and including all reissues, reexaminations, divisions, renewals, extensions or supplementary protection certificates, provisionals, continuations and continuations-in-part thereof and the like; (ii) all trade secrets,

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


confidential and proprietary information, including unpatented inventions, invention disclosures, moral or economic rights of authors and inventors (however denominated), technical data, know-how, mask works, specifications, methods (whether or not patentable), designs, processes, procedures, and technology; (iii) all copyrights, copyright registrations and applications therefor, and all other rights corresponding thereto throughout the world; and (iv) all industrial designs and any registrations and applications therefor throughout the world.

Inventory ” is defined in Section 2.03(a)(i) .

Know-How License ” is defined in Section 2.02 .

Law ” means any applicable federal, national, supranational, state, provincial, local or similar statute, law, ordinance, regulation, rule, code, Governmental Order, requirement or rule of law (including common law), including the U.S. Foreign Corrupt Practices Act of 1977, the Public Health Service Act and the FDCA.

Liabilities ” means any and all damages, debts, liabilities and obligations, Losses, claims, Taxes, interest obligations, deficiencies, judgments, assessments, fines, fees, penalties, and expenses, including those arising under any Law, Action or Governmental Order and those arising under any contract, agreement, arrangement, commitment or undertaking.

Licensed IP ” means the Licensed Know-How and the CVAC Intellectual Property together.

Licensed Know-How ” means the CVAC Know How, CVAC Trademarks and Further Know How to be licensed to Purchaser under the Know-How License.

Loss ” or “ Losses ” means any claims, actions, causes of action, judgments, awards, suits, fines, Liabilities, losses, costs (including the costs of defense and enforcement of this Agreement and the Ancillary Agreements and the cost of enforcing any right to indemnification hereunder), damages, expenses or amounts paid in settlement (in each case, including reasonable attorneys’ and experts’ fees and expenses).

Material Adverse Effect ” means an event, change, condition, matter, circumstance or thing, whether individually or when aggregated with all other events, changes, conditions, matters, circumstances or things of a like kind which are reasonably likely to occur, has or would be considered reasonably likely to have a material adverse effect on the business, assets, liabilities, financial or trading position, profitability or prospects of the Seller taken as a whole’.

Neopharm Agreement ” is defined in Section 2.03(a)(ii) .

Net Sales ” means, with respect to any Covered Product, the gross amounts that Purchaser or any Purchaser Related Party is entitled to receive, for sales in the applicable Royalty Territory of such Covered Product by Purchaser or any Purchaser Related Party for monetary value for use or consumption by the general public, less the following deductions, to the extent reasonable and customary and actually allowed and taken with respect to such sales:

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


(i) reasonable cash, trade or quantity discounts, charge-back payments, and rebates actually granted to trade customers, managed health care organizations, pharmaceutical benefit managers, group purchasing organizations and national, state, or local government;

(ii) credits, rebates or allowances actually allowed upon prompt payment or on account of claims, damaged goods, rejections or returns of such Covered Product, or other similar payments to wholesalers or distributors, including in connection with recalls, and the actual amount of any write-offs for bad debt ( provided that an amount subsequently recovered will be treated as Net Sales);

(iii) reasonable packaging, freight, postage, shipping, transportation, warehousing, handling and insurance charges, in each case actually allowed or paid for delivery of such Covered Product and calculated in accordance with the standard practices of Purchaser or Purchaser Related Party, as applicable, consistently applied across its and their respective products in an amount not exceeding 5 % of the gross sales;

(iv) taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of such Covered Product, including VAT, excise taxes and sales taxes, in each case calculated in accordance with the standard practices of Purchaser or Purchaser Related Party, as applicable, consistently applied across its and their respective products; and

(v) the portion of any annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-48) and other comparable laws that is reasonably allocable to the sale of such Covered Product in accordance with the standard practices of Purchaser or Purchaser Related Party, as applicable, consistently applied across its and their products.

Notwithstanding the foregoing, amounts received by Purchaser or any Purchaser Related Party for the sale of such Covered Product among Purchaser or any Purchaser Related Parties for resale shall not be included in the computation of Net Sales hereunder. Net Sales shall be accounted for in accordance with standard accounting practices, as practiced by Purchaser or Purchaser Related Party, as applicable, in the relevant country in the Territory, but in any event in accordance with GAAP, as consistently applied in such country in the Territory. For clarity, a particular deduction may only be accounted for once in the calculation of Net Sales. In computing Net Sales, transfers of any samples of Covered Product at no cost for promotional or educational purposes shall be disregarded.

Net Sales Report ” is defined in Section 2.07(c) .

New CVAC Product ” means any formulation containing mannosylated fusion protein conjugated to mucin1; that has been pulsed ex vivo into a patients’ dendritic cells and then reinjected back into said patient developed by Purchaser or a Purchaser Related Party after the Effective Date.

New License ” is defined in Section 6.03(d)

Nonassigned Assets ” is defined in Section 2.05(a) .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


Notified Party ” is defined in Section 2.07(g)(viii) .

Notifying Party ” is defined in Section 2.07(g)(viii) .

Options ” is defined in Section 1.01 .

Party ” or “ Parties ” are defined in the Preamble.

Permitted Encumbrances ” means (i) mechanics’, carriers’, workers’, repairers’ and other similar liens arising or incurred in the ordinary course of business relating to obligations as to which there is no default on the part of Seller or the validity or amount of which is being contested in good faith by appropriate proceedings, or pledges, deposits or other liens securing the performance of bids, trade contracts, leases or statutory obligations (including workers’ compensation, unemployment insurance or other social security legislation); and (ii) all statutory liens for Taxes not yet due.

Person ” means any individual, corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust, company (including any limited liability company or joint stock company), firm or other enterprise, association, organization, entity or Governmental Authority.

Phase I Study ” means any study in humans which provides for the introduction of a product into humans, conducted in healthy volunteers or patients, to obtain initial information on product safety, tolerability, pharmacological activity or pharmacokinetics, as further defined in 21 C.F.R. § 312.21(a) (or the equivalent thereof outside the United States).

Prime Rate ” means the prime rate as published by Citibank, N.A., New York, New York, from time to time.

Purchased Assets ” is defined in Section 2.03(a) .

Purchaser ” is defined in the Preamble.

Purchaser Indemnified Party ” is defined in Section 7.02 .

Purchaser’s Knowledge ”, “ Knowledge of Purchaser ” or similar terms used in this Agreement mean the knowledge of the Persons listed in Schedule 1.01(b) as of the Effective Date (or, with respect to a certificate delivered pursuant to this Agreement, as of the date of delivery of such certificate). Purchaser shall be deemed to have had such knowledge if Purchaser or any of the persons listed in Schedule 1.01(b) , had actual knowledge or could have obtained such knowledge after due inquiry.

Purchaser Related Party ” means (i) any Affiliate of Purchaser or (ii) any Third Party that acquires rights to any of the Purchased Assets or any Covered Product from Purchaser or any of its Affiliates or any other Purchaser Related Party.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


Regulatory Approval ” means all approvals and authorizations including early access schemes and physician prescription of any Regulatory Authority in a particular country or regulatory jurisdiction in the Territory that are necessary for the commercial sale of a Covered Product in such jurisdiction in accordance with applicable Laws, but excluding any pricing or reimbursement approvals.

Regulatory Authority ” means any Governmental Authority involved in the granting of Regulatory Approval in any country or regulatory jurisdiction in the Territory, including the FDA in the United States.

Restricted Territory ” means worldwide except for Israel and Palestine.

Royalty Territory ” means, with respect to any Covered Product, each country within the Territory with respect to which the applicable Royalty Term has not expired, collectively.

Royalty Term ” means, with respect to any Covered Product, on a country-by-country basis, the period of time commencing on the date of First Commercial Sale of such Covered Product in such country and ending on the later of (i) the expiry of patent or patents, on a country by country basis, which would be infringed by the making, using, selling, offering to sell, or importing, of the Covered Product, or while a period of market exclusivity such as supplemental protection certificates or regulatory exclusivity (e.g. orphan drug status, data protection) is in operation or (ii) twelve (12) years from the date of First Commercial Sale of such Covered Product in any country.

Securities Act ” means the Securities Act of 1933, as amended, and, as applicable, the rules and regulations promulgated thereunder.

Seller ” is defined in the Preamble.

Seller Indemnified Party ” is defined in Section 7.03 .

Seller’s Knowledge ”, “ Knowledge of Seller ” or similar terms used in this Agreement mean the knowledge of the Persons listed in Schedule 1.01(c) as of the Effective Date (or, with respect to a certificate delivered pursuant to this Agreement, as of the date of delivery of such certificate). Seller shall be deemed to have had such knowledge if Seller or any of the persons listed in Schedule 1.01(c) , had actual knowledge or could have obtained such knowledge after due inquiry.

Shares ” means all shares of Common Stock to be acquired by Seller hereunder.

Shareholder ” is defined in the Preamble.

Successful Financing ” is defined in Section 2.06(b)(ii) .

Tax ” or “ Taxes ” means any and all taxes of any kind together with charges, fees, levies or other assessments, including any income tax or franchise taxes, any alternative or add-

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


on minimum taxes, any gross income, gross receipts, premium, sales, use, ad valorem, value-added, transfer, profits, license, payroll (e.g., social security, Medicare, unemployment, disability), employment, withholding (on amounts paid or received), excise, severance, stamp, occupation, property, environmental or windfall profit tax, custom duty or other tax, governmental fee or other like assessment together with any interest, penalty, addition to tax or additional amount imposed by any Governmental Authority responsible for the imposition of any such tax.

Tax Returns ” means any and all returns, reports, forms and statements (including, elections, declarations, amendments, schedules, information returns or attachments thereto) required to be filed with a Governmental Authority with respect to Taxes.

Technology License Agreement ” means the original Technology Licence Agreement of 31 May 2001 between Ilexus Pty Ltd, Cancer Vac Ltd and Prima Resources Ltd, subsequently varied (2005) and novated (2012), which is currently in force between the Burnet Institute and Seller.

Territory ” means every country, territory, possession or other political subdivision of the world.

Third Party ” means any Person other than Purchaser, Seller or any of their respective Affiliates.

Third Party Claim ” is defined in Section 7.05(b) .

Threshold Level ” means nine point nine percent (9.9%) of: (i) Purchaser’s equity on a Fully-Diluted As-Converted Basis and (ii) the total number of votes entitled to be cast at any meeting of the stockholders of Purchaser, excluding votes entitled to be cast by the holders of any Exempt Securities outstanding as of the applicable computation date.

Transfer Agreement ” means the agreement regulating the transfer of the Purchased Assets to be executed by Purchaser and Seller at the Closing, substantially in the form of Exhibit A.

Transferred Books and Records ” is defined in Section 2.03(a)(iii) .

Transferred Contracts ” is defined in Section 2.03(a)(ii) .

Use ” means making, using, selling, offering to sell or importing.

Valid Claim ” means any claim of (a) any issued and unexpired Licensed Patent that has not been (i) revoked or held unenforceable, unpatentable or invalid by a Governmental Authority of competent jurisdiction in a decision that is not appealable or that has not been appealed within the time allowed for appeal or (ii) abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

SECTION 1.02. Interpretation and Rules of Construction.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


In this Agreement, except to the extent otherwise provided or that the context otherwise requires:

(a) when a reference is made in this Agreement to an Article, Section, Exhibit or Schedule, such reference is to an Article or Section of, or an Exhibit or Schedule to, this Agreement unless otherwise indicated;

(b) the table of contents and headings for this Agreement are for reference purposes only and do not affect in any way the meaning or interpretation of this Agreement;

(c) whenever the words “include,” “includes” or “including” are used in this Agreement, they are deemed to be followed by the words “without limitation;”

(d) the words “hereof,” “herein” and “hereunder” and words of similar import, when used in this Agreement, refer to this Agreement as a whole and not to any particular provision of this Agreement;

(e) all terms defined in this Agreement have the respective meanings defined herein when used in any certificate or other document made or delivered pursuant hereto, unless otherwise defined therein;

(f) the definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms;

(g) references to a Person are also to its successors and permitted assigns; and

(h) the use of “or” is not intended to be exclusive unless expressly indicated otherwise.

ARTICLE II.

GRANT OF SUB-LICENSE, PURCHASE AND SALE

SECTION 2.01. Grant of Sub-License.

Upon the terms and subject to the conditions of this Agreement, at Closing, Seller shall grant to Purchaser a worldwide exclusive sub-license under its CVAC License to the extent permitted by Law pursuant to the terms of the license specified in Exhibit B (the “ CVAC Sub-License ”) which is to be entered into at Closing.

SECTION 2.02. Know-How License.

(a) Upon the terms and subject to the conditions of this Agreement, at Closing, Seller shall grant to Purchaser a non-exclusive license and sub-license (as applicable) of the Licensed Know-How to the extent permitted by Law pursuant to the terms of the license specified in Exhibit C (the “ Know-How License ”) which is to be entered into at Closing.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12


(b) Purchaser acknowledges and agrees that Seller may retain copies of any tangible embodiments of Licensed Know-How for use in accordance with the Know-How License.

SECTION 2.03. Purchase and Sale of Assets.

(a) Upon the terms and subject to the conditions of this Agreement, at Closing, Seller shall sell, assign, transfer and convey to Purchaser, and Purchaser shall purchase, assume and accept from Seller, on an “as is, where is” basis, free and clear of all Encumbrances other than Permitted Encumbrances, the following listed Seller’s rights, titles and interest in and to the assets, rights and properties of every nature, kind and description, tangible and intangible, wherever located, whether or not carried on the books of Seller exclusively relating to CVAC and the CVAC Products (for the avoidance of doubt: in particular, but without limitation, the Excluded Assets are explicitly excepted) (collectively, the “ Purchased Assets ”) by concluding the Transfer Agreement at Closing (with regard to the Transferred Contracts only if the third party consent has been obtained until Closing pursuant to Section 2.05(a) ):

(i) all inventory of the CVAC Products and their components, wherever located, held by Seller, including raw materials, work in process, samples, packaging, supplies, carriers, matrices, cell lines, vectors, clones, services parts, ancillary devices used, for example, in methods using the CVAC Products, purchased parts and goods, damaged and fragmented or expired inventory, as listed on Schedule 2.03(a)(i) (the “ Inventory ”) and the machinery and equipment (including all manufacturing equipment, cell culture equipment, protein purification equipment, assembly equipment and laboratory and testing equipment used for research and development) and other tangible personal property related to the CVAC Products as well listed on Schedule 2.03(a)(i) ;

(ii) all rights and incidents of interest of, and benefits accruing to, the Seller under the DBI-Development Agreement and the Supply, Distribution and Licensing Agreement between Seller and Neopharm Ltd. dated 19 February 2014 (“ Neopharm Agreement ” and together with the DBI-Development Agreement the “ Transferred Contracts ”);

(iii) books, files, papers, correspondence, documents, databases, software, reports, laboratory notebooks, plans and records in Seller’s possession that are (aa) exclusively related to the CVAC Products, Purchased Assets relating to CVAC and Assumed Liabilities relating to CVAC; or (bb) related to the Further Know-How in particular, but without limitation, as listed in the dataroom index in the course of the due diligence as of 30 April 2016 attached as Schedule 2.03(a)(iii) (the “ Transferred Books and Records ”);

(iv) all claims, causes of action, defenses and rights of offset or counterclaim (at any time or in any manner arising or existing, whether choate or inchoate, known or unknown, contingent or noncontingent) relating solely and exclusively to any of the Purchased Assets;

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13


(v) all of Seller’s rights under warranties, indemnities and all similar rights against third parties to the extent related to any Purchased Assets;

(vi) the goodwill of Seller relating to the Purchased Assets; and

(b) Notwithstanding anything in Section 2.03(a) to the contrary, Seller shall not sell, convey, assign or transfer, nor cause to be sold, conveyed, assigned or transferred, to Purchaser, and Purchaser shall not purchase, and the Purchased Assets shall not include, Seller’s right, title and interest in and to any assets of Seller not expressly included in the Purchased Assets (the “ Excluded Assets ”), including without limitation:

(i) the CVAC License;

(ii) the Licensed Know-How;

(iii) all Cash and Cash Equivalents;

(iv) all rights of Seller and its Affiliates under this Agreement and the Ancillary Agreements;

(v) all current and prior insurance policies of Seller and its Affiliates and all rights of any nature with respect thereto, including all insurance recoveries thereunder and rights to assert claims with respect to any such insurance recoveries;

(vi) all prepaid expenses, credits, advance payments, claims, security, refunds, rights of recovery, rights of set-off, rights of recoupment, deposits, charges, sums and fees (including any such item relating to the payment of Taxes) relating to any of the Purchased Assets;

(vii) all accounts and notes receivable; and

(viii) all claims, causes of action, defenses and rights of offset or counterclaim (at any time or in any manner arising or existing, whether choate or inchoate, known or unknown, contingent or noncontingent) not relating solely and exclusively to any of the Purchased Assets.

SECTION 2.04. Assumption and Exclusion of Liabilities.

(a) Upon the terms and subject to the conditions set forth in this Agreement, Purchaser shall assume, and agree to pay, perform and discharge as and when due and owing, only the following Liabilities (the “ Assumed Liabilities ”):

(i) any and all Liabilities arising from Purchaser’s ownership, use or operation of the Purchased Assets or the Exploitation of the CVAC Products, the CVAC Sub-License or the Know-How License after the Closing Date;

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

14


(ii) any and all Liabilities of the Seller arising from the Transferred Contracts to the extent relating to performance thereunder following the Closing; provided , however , that Purchaser is not assuming any Liabilities of the Seller in respect of a breach of or default under, or any non-compliance with respect to, any Transferred Contract that occurred on or before, or that relates to or commenced during any period prior to, the Closing Date; and

(iii) any Liabilities of the Purchaser or any of its Affiliates arising or incurred in connection with the negotiation, preparation, investigation and performance of this Agreement, the other Transaction Documents and the transactions contemplated hereby and thereby, including, without limitation, fees and expenses of counsel, accountants, consultants, advisors and others.

(b) Seller shall retain, and shall be responsible for paying, performing and discharging as and when due and owing, and Purchaser shall not assume or have any responsibility for, the Excluded Liabilities. “ Excluded Liabilities ” means all Liabilities of the Seller, other than Assumed Liabilities, including the following:

(i) all Liabilities relating to or arising out of the Excluded Assets;

(ii) any and all Liabilities arising from Seller’s ownership, use or operation of the Purchased Assets or the Exploitation of the CVAC Products or the Licensed Know-How on or before the Closing Date;

(iii) all accounts payable, Taxes and other accrued expenses of Seller, any of Seller’s Affiliates or any other Person (whether direct or as a result of successor liability, transferee liability, joint and several liability or contractual liability), except as expressly provided in this Agreement;

(iv) all Encumbrances on the Purchased Assets, other than the Permitted Encumbrances;

(v) all Liabilities arising from accidents, occurrences, misconduct, negligence, breach of fiduciary duty or statements made or omitted to be made (including libelous or defamatory statements) on or prior to the Closing Date, or as a result of any Action, whenever initiated, relating to any of the foregoing, including any such Liability for (i) infringement or misappropriation of any Intellectual Property or any other rights of any Person (including any right of privacy or publicity); (ii) breach of product warranties; (iii) injury, death, property damage or other losses arising with respect to or caused by any products or services manufactured, made, designed, maintained, supported, developed, sold, licensed, marketed or otherwise distributed by the Seller, or the manufacture or design of such products; or (iv) violations of any Law or Government Order;

(vi) all Liabilities incurred in connection with shutting down, uninstalling and removing equipment not purchased by Purchaser;

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

15


(vii) all Liabilities associated with any Contract that is not a Transferred Contract;

(viii) all Liabilities associated with any Contract that is a Transferred Contract to the extent such Liabilities accrued, arose out of or related to events, facts or circumstances that occurred on or prior to the Closing Date;

(ix) all Liabilities associated with debt, loans or credit facilities of Seller or any of its Affiliates owing to financial institutions;

(x) Seller’s obligations under this Agreement; and

(xi) any Liabilities of Seller or any of its Affiliates arising or incurred in connection with the negotiation, preparation, investigation and performance of this Agreement, the other Transaction Documents and the transactions contemplated hereby and thereby, including, without limitation, fees and expenses of counsel, accountants, consultants, advisors and others.

SECTION 2.05. Non-Assignable Assets .

(a) Notwithstanding anything in this Agreement to the contrary, this Agreement shall not constitute an agreement to assign or transfer any Purchased Asset that is not assignable or transferable by Law or without the consent of any Person, other than Seller, Purchaser or any of their respective Affiliates, to the extent that such consent shall not have been given prior to the Closing (each, a “ Nonassigned Asset ”); provided , however , that Seller with respect to the Purchased Assets that cannot be assigned or transferred without consent shall use, both prior to and for twelve (12) months after the Closing, commercially reasonable efforts to obtain, and Purchaser shall use its commercially reasonable efforts to assist and cooperate with Seller in connection therewith, all necessary consents to the assignment and transfer of each Nonassigned Asset, and shall keep Purchaser reasonably informed as to the status of such efforts; provided , further , that none of Seller, Purchaser or any of their respective Affiliates shall be required to pay money to any Third Party, commence any litigation or offer or grant any accommodation (financial or otherwise) to any Third Party in connection with such efforts. With respect to any Nonassigned Asset for which consent is required for the assignment or transfer, for a period beginning on the Closing Date and ending on the earlier of (i) the time such requisite consent is obtained and such Nonassigned Asset is transferred and assigned to Purchaser or (ii) the date that is twenty four (24) months after the Closing Date, Seller shall use commercially reasonable efforts to provide to Purchaser substantially comparable benefits thereof and shall enforce, at the request of and for the benefit of Purchaser, any rights of Seller arising thereunder against any Person, including the right to seek any available remedies or to elect to terminate in accordance with the terms thereof upon the advice of Purchaser. To the extent that Seller provides Purchaser with benefits of any Nonassigned Asset, Purchaser shall perform, at reasonably directed by Seller, the related obligations of Seller thereunder.

SECTION 2.06. Expense Consideration .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

16


(a) Expense Consideration . The Expense Consideration for the expenses of Seller shall be $100,000 (the “ Expense Consideration ”), which shall be paid by Purchaser to Seller within fifteen days (15) of the Closing Date (50%) and 3 months thereafter (50%).

(b) Equity Participation .

(i) Initial Stock Issuance . As consideration for any asset related to the Further Know-How, i.e. (aa) the Further Know-How and (bb) the Purchased Assets related to the Further Know-How (i.e. in particular, but without limitation, the DBI-Development Agreement Agreement and the Transferred Books and Records relating to the Further Know How as described in Section 2.03(a)(iii)(bb) ), on the Closing Date, Purchaser shall issue to Seller 1,980,000 shares of Series A Preferred Stock in the Purchaser representing nine point nine percent (9.9%) of the outstanding capital stock in the Purchaser on a fully converted basis (currently equivalent to 3,960,000 shares of Common Stock), which shares shall be duly authorized and validly issued and considered fully paid and non-assessable, with appropriate legends with a full anti-dilution protection for the first $ 20,000,000.00 equity financing raised. Purchaser shall grant to Seller an options to purchase shares of Common Stock of Purchaser representing up to five percent (5%) of the issued and outstanding capital stock of Purchaser exercisable upon the next equity financing round but no later than the fourth anniversary of the Closing Date, at a purchase price equal to a 25% premium to the pre -money per share valuation of the Purchaser in this financing round.

(ii) Anti-Dilutive Issuances . After the Closing Date, Purchaser shall immediately issue to Seller, for no additional consideration, any additional shares of Common Stock necessary to ensure that the total number of shares of capital stock of Purchaser issued to Seller (whether or not subsequently sold or transferred) does not at any time prior to, or upon the occurrence of, a Successful Financing represent less than the Threshold Level. Such additional shares of Common Stock shall be issued to Seller concurrently with the issuance by Purchaser of any shares of Common Stock, Options or Convertible Securities other than Exempt Securities. Any such additional shares of Common Stock, when issued in accordance with this Section 2.06(b)(ii) , shall be duly authorized and validly issued and considered fully paid and nonassessable. Purchaser’s obligation to make additional issuances of Common Stock to Seller pursuant to this Section 2.06(b)(ii) shall continue until (x) all of the shares of capital stock to be issued in connection with a minimum equity financing of $ 20,000,000.00 (“ Successful Financing ”) have been issued and (y) Seller has been issued all of the shares required to be issued pursuant to this Section 2.06(b)(ii) to ensure that its interests are not diluted as a result of the Successful Financing. Notwithstanding anything in this Section 2.06(b)(i) to the contrary, in no event shall Seller be entitled to receive, pursuant to this Section 2.06(b)(ii) , a number of shares representing more than the Threshold Level at and as of the occurrence of a Successful Financing, even if a Successful Financing occurs during the course of a transaction or series of transactions and, after the Successful Financing, Purchaser issues additional shares of capital stock in connection with such transaction or transactions, as the case may be. Purchaser shall maintain or increase the number of authorized shares of Common Stock in order to issue to Seller such additional shares of

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

17


Common Stock in accordance with this Section 2.06(b)(ii) . For so long as Purchaser is obligated to make additional issuances of Common Stock to Seller pursuant to this Section 2.06(b)(ii) , Purchaser shall deliver to Seller within sixty (60) days after the end of each Calendar Quarter a statement setting forth: (A) the number of shares of each class and series of capital stock of Purchaser and the number of securities convertible into or exercisable for such shares of capital stock, outstanding at the end of such Calendar Quarter; (B) the number of shares of Common Stock issuable upon conversion or exercise of any outstanding Options, warrants or other securities that are convertible or exercisable for Common Stock, and the exchange ratio or exercise price applicable thereto; and (C) the total number of shares of capital stock of Purchaser in the employee stock option pool, in each case ((A) through (C)) in sufficient detail to permit Seller to calculate its percentage equity ownership of Purchaser and certified as being true, complete and correct by the chief financial officer or chief executive officer of Purchaser in his or her official capacity.

(iii) Lock-Up . Seller hereby agrees that it will not, without the prior written consent of Purchaser, which shall not be unreasonably withheld, during the period of 18 months commencing on the Closing Date(A) lend, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any shares of Common Stock held immediately prior to the effectiveness of the registration statement for the offering or (B) enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of any shares of Common Stock, whether any such transaction described in clause (A)  or clause (B)  above is to be settled by delivery of shares of Common Stock, in cash or otherwise. The foregoing provisions of this Section 2.06(b)(iii) shall not apply to the sale of any shares of Common Stock to an underwriter pursuant to an underwriting agreement and shall only be applicable to Seller if all officers, directors and holders of more than one percent (1%) of the outstanding shares of Common Stock (after giving effect to the conversion of all Convertible Securities) enter into similar agreements. The underwriters in connection with the offering are intended third party beneficiaries of this Section 2.06(b)(iii) and shall have the right, power and authority to enforce the provisions hereof as though they were a party hereto. Seller further agrees to execute such agreements as may be reasonably requested by Purchaser or any underwriter that are consistent with this Section 2.06(b)(iii) or that are necessary to give further effect hereto. In order to enforce the covenants set forth in this Section 2.05(b)(iii) , Purchaser may impose stop-transfer instructions with respect to the shares of Common Stock held by Seller until the end of such restricted period.

(iv) Board Seat: As long as the Seller holds more than 5% of Purchaser’s outstanding capital stock but at least for a period of one year from the Closing Date, Seller shall be entitled to have one Board seat at Purchaser. Purchaser shall be obliged to procure that all future shareholders of Purchaser are legally bound to obey this right of Seller and to participate within their legal powers in appointing/revoking/replacing the person designated by Seller for such Board seat as per the instructions of Seller.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

18


(v) Tag Along Right : Seller shall have the right in each case of Joe Hernandez and/or Affiliates selling shares in Purchaser that Joe Hernandez and/or Affiliates respectively make their best effort that Seller can tag along in such sale on a pro rata- basis.

SECTION 2.07.

(a) Development Milestone Payments . Within the Royalty Term and upon the terms and subject to the conditions of this Agreement, Purchaser shall make (or cause to be made) as consideration for any asset relating to CVAC, i.e. (aa) the CVAC Sub-License; (bb) the Know-How License (except for the Further Know-How); and (cc) the Purchased Assets relating to CVAC (i.e. in particular, but without limitation, the Neopharm Agreement and the Transferred Books and Records relating to CVAC as described in Section 2.03(a)(iii)(aa) ) each of the one-time, non-refundable, non-creditable payments set forth below (each, a “ Development Milestone Payment ”) to Seller no later than thirty (30) days following the first occurrence of the corresponding milestone event set forth below (each a “ Development Milestone Event ”). For the sake of clarity, (i) each Development Milestone Payment shall become due and payable upon the first occurrence of the corresponding Development Milestone Event, regardless of whether such Development Milestone Event is achieved by Purchaser or by a Purchaser Related Party,(ii) the following milestones apply individually- with the exception of milestone 6 – to two indications (eg second remission ovarian cancer and pancreatic cancer). Example: based on the assumption that second remission ovarian canceer will start directly with Phase III, the aggregate amount of the Development Milestone Payments payable pursuant to this Section 2.07(a) shall not exceed $[***] for ovarian cancer and $[***] for the second cancer indication. A one off milestone of $[***] will be payable on first commercial sale in a third indication.

 

Development Milestone Event

   Development
Milestone Payment
 

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

(b) Commercial Milestone Payments . Within the Royalty Term and upon the terms and subject to the conditions of this Agreement, Purchaser shall make (or cause to be made) each of the one-time, non-refundable, non-creditable payments set forth below (each, a “ Commercial Milestone Payment ”) to Seller no later than thirty (30) days following the first occurrence of the corresponding milestone event set forth below (each a “ Commercial Milestone

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

19


Event ”). For the sake of clarity, (i) each Commercial Milestone Payment shall become due and payable upon the first occurrence of the corresponding Commercial Milestone Event, regardless of whether such Commercial Milestone Event is achieved by Purchaser or by a Purchaser Related Party, and (ii) the aggregate amount of the Commercial Milestone Payments payable pursuant to this Section 2.07(b) shall not exceed $[***].

 

Commercial Milestone Event

   Commercial Milestone Payment  

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

[***]

   $ [***]   

(c) Contingent Payments I . Upon the terms and subject to the conditions of this Agreement, on a Covered Product-by-Covered Product basis, Purchaser shall pay (or cause to be paid) to Seller with respect to Net Sales of each Covered Product, an amount equal to (the “ Contingent Payments I ”):

(i) [***]

(ii) [***]

(iii) [***]

By way of example only, if, during a Calendar Year, the Net Sales of a Covered Product were [***].

Purchaser shall pay (or cause to be paid) the Contingent Payments I to Seller with respect to each Calendar Quarter within ninety (90) days after the end of such Calendar Quarter, and each such Contingent Payment I shall be accompanied by a report that sets forth the Net Sales of all Covered Products in the Territory during such Calendar Quarter and the amount payable to Seller (each such report, a “ Net Sales Report ”).

(d) Contingent Payments II. Purchaser shall pay to Seller [***] of the revenue generated by Purchaser from such DBI-Sub-Licensees to which Seller has introduced the ICAN System which are listed in Schedule 2.07(d) , or affiliates of those listed persons/entities (the “ Contingent Payments II ”).

Purchaser shall pay (or cause to be paid) the Contingent Payments II to Seller with respect to each Calendar Quarter within ninety (90) days after the end of such Calendar Quarter, and each such Contingent Payment II shall be accompanied by a report that sets forth the DBI-Revenues during such Calendar Quarter and the amount payable to Seller (each such report, a “ DBI-Revenue Report ”).

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

20


(e) Performance by Purchaser Related Parties . The Parties acknowledge that obligations under this Agreement may be performed by Affiliates of Purchaser. Purchaser guarantees performance of this Agreement by its Affiliates, notwithstanding any assignment to Affiliates in accordance with Section 8.06 of this Agreement. Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that the Affiliates/entities may not make decisions inconsistent with this Agreement, nor amend the terms of this Agreement or act contrary to its terms in any way. In case any Affiliate of a Party materially breaches this Agreement, the non-breaching Party will have the right to bring a cause of action directly against the other Party whether or not its Affiliate is named as a defendant in that action.

(f) Agreements with Purchaser Related Parties . Any agreement between Purchaser and any Purchaser Related Party under which such Purchaser Related Party acquires any rights to the Purchased Assets or any Covered Product (including rights under the CVAC Sub-License) shall (i) be consistent with the terms and conditions of this Agreement; (ii) not in any way diminish, reduce or eliminate any obligations of Purchaser under this Agreement (in particular but without limitation the obligation under Section 6.03 ); (iii) require such Purchaser Related Party to provide Purchaser with all information required to prepare the Net Sales Reports; (iv) require such Purchaser Related Party to comply with all applicable terms of this Agreement, including the obligation to maintain books and records consistent with the terms of Section 2.07(g)(iv) and to permit audits of Financial Records pursuant to Section 2.07(g)(v) . Subject to Section 8.06 , such agreement may include the assignment of certain rights under this Agreement, and delegation of certain obligations under this Agreement, of Purchaser to such Purchaser Related Party, provided that Purchaser shall remain liable for the performance of such obligations by such Purchaser Related Party. Purchaser shall provide Seller with a copy of any such agreement within thirty (30) days after the execution thereof. Purchaser may neither sell nor sublicense nor in any other way grant rights to the Purchased Assets or any Covered Product (including rights under the CVAC Sub-License and the Know-How License) as part of an Asset Deal without the prior written consent of Seller. However, the Purchaser may enter into an interest purchase agreement (M&A transaction) without prior authorization of Seller.

(g) Payment Terms .

(i) Method of Payment . Each payment under this Agreement shall be made by electronic transfer in immediately available funds via either a bank wire transfer, an automated clearing house (ACH) mechanism, or any other means of electronic funds transfer, at Purchaser’s election, to such bank account as Seller shall designate in a notice at least five (5) Business Days before the payment is due.

(ii) Currency . All payments due under this Agreement shall be made in Australian dollars. Whenever, for the purposes of calculating Contingent Payments, conversion from any foreign currency will be required, all amounts will first be calculated in the currency of sale and then converted into Australian dollars by applying Seller’s customary and usual currency conversion procedures, consistently applied.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

21


(iii) Blocked Payments . If, at any time, legal restrictions prevent the prompt remittance of part or all Contingent Payments with respect to any country in the Territory where any Covered Product is sold, Contingent Payments shall continue to be accrued in such country and Net Sales in such country shall continue to be reported, but such Contingent Payments will not be paid until they may be removed from the country or, at Seller’s request, shall be paid in the local currency into a local bank designated by Seller for the account of Seller. If such Contingent Payments are accrued, then at such time as Purchaser or Purchaser Related Party, as applicable, is able to remove currency from such country it shall also remove and pay such Contingent Payments accrued on Seller’s behalf.

(iv) Record Keeping . Purchaser shall keep, and shall cause Purchaser Related Parties to keep, books and accounts of record in connection with the sale of Covered Products in the Territory, including records of Net Sales, exchange rates and royalty payments (collectively, the “ Financial Records ”), in accordance with GAAP and in sufficient detail to permit accurate determination of all figures necessary for verification of Commercial Milestone Payments and Contingent Payments to be made to Seller hereunder. Purchaser shall maintain, and shall cause Purchaser Related Parties to maintain, such Financial Records for a period of at least three (3) years after the end of the Calendar Quarter in which they are generated.

(v) Audits . Upon thirty (30) days prior written notice from Seller, Purchaser shall permit an independent certified public accounting firm of nationally recognized standing selected by Seller and reasonably acceptable to Purchaser, to examine, at Seller’s sole expense, the relevant Financial Records of Purchaser and the Purchaser Related Parties for the purpose of verifying the Net Sales Reports, DBI-Revenue Reports and the Commercial Milestone Payments and Contingent Payments made to Seller hereunder. Seller shall be entitled to conduct an audit in accordance with this Section 2.07(g)(v) not more than once in any Calendar Year and such audit shall be limited to the pertinent Financial Records from any Calendar Year ending not more than three (3) years prior to the date of the request. The accounting firm shall be provided access to such Financial Records at the facility(ies) of Purchaser and the Purchaser Related Parties where such Financial Records are normally kept and such audit shall be conducted during the normal business hours of Purchaser or the Purchaser Related Party, as applicable. The accounting firm shall enter into a confidentiality agreement with Purchaser on terms substantially similar to those set forth in Section 5.01 prior to being provided access to any Financial Records. Upon completion of the audit, the accounting firm shall provide Seller and Purchaser with a written report disclosing any discrepancies in the Net Sales Reports, DBI-Revenue Reports, Commercial Milestone Payments or Contingent Payments, if any, and in each case, the specific details concerning any discrepancies. Any information provided by Purchaser or the Purchaser Related Parties to the accounting firm and the written report provided by the accounting firm shall be deemed to be Confidential Information for purposes of this Agreement.

(vi) Underpayments/Overpayments . If a report of an independent certified public accounting firm submitted to the Parties in accordance with Section 2.07(g)(v)

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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shows any underpayment of Commercial Milestone Payments or Contingent Payments, Purchaser shall remit (or cause to be remitted) to Seller within thirty (30) days after receipt of such report by Purchaser, (x) the amount of such underpayment and (y) if such underpayment exceeds five percent (5%) of the total amount owed to Seller for the Calendar Year then being audited, the reasonable fees and expenses of such accounting firm performing the audit, subject to reasonable substantiation thereof. If such accounting firm’s written report shows any overpayment of Commercial Milestone Payments or Contingent Payments, Purchaser shall receive a credit equal to such overpayment against the Commercial Milestone Payments or Contingent Payments otherwise payable to Seller or a refund in immediately available cash, as specified by Purchaser.

(vii) Interest . Any payment of any sums due and payable to Seller hereunder that is more than forty-five (45) days past due shall be subject to interest at an annual percentage rate of Prime Rate plus two percent (2%) if such payment is not made within forty-five (45) days of Purchaser’s receipt of notice that such amount is past due. Likewise, any overpayment that is not refunded within forty-five (45) days after the date upon which notice of such overpayment was received shall thereafter be subject to interest at an annual percentage rate of Prime Rate plus two percent (2%). Notwithstanding the preceding, if a Party contests any amounts due hereunder in good faith and promptly notifies the other Party of such dispute, interest shall not accrue as to amounts being so contested until forty-five (45) days following the presentation of such notice to the other Party.

(viii) Late Payment Collection . If a Party (for purposes of this Section 2.07(g)(viii) , the “ Notifying Party ”) determines in good faith that another Party failed to pay any sum (in immediately available funds) when due and owing (for purposes of this Section 2.07(g)(viii) , the “ Notified Party ”), then, the Notifying Party shall promptly send written notice of such determination to the Notified Party. If the Notified Party either (i) acknowledges that such amounts are due and owing but fails to make such payment within five (5) Business Days of receiving such notice or (ii) denies that such amounts are due, the Notified Party shall reimburse the Notifying Party for all costs incurred in collecting any payments conclusively determined to have been overdue and related interest, including, without limitation, reasonable attorneys’ fees, legal costs, court costs and collection agency fees; provided , however, that if a court or neutral arbiter determines that no amounts had been due or owing at the time the Notifying Party delivered its notice to the Notified Party, the Notifying Party will reimburse the Notified Party for all costs incurred in defending itself, including, without limitation, reasonable attorneys’ fees, legal costs, court costs and collection agency fees. For the avoidance of doubt, any amounts paid pursuant this Section 2.07(g)(viii) will not also be deemed Losses for the purposes of indemnification under Article VI.

(ix) Taxes . All payments under this Agreement shall be made without any deduction or withholding for or on account of any Tax. The net amount of any payment by Purchaser or Purchaser Related Party to Seller under this Agreement shall be in the amount specified under this Agreement, after deduction or withholding for or on account of any Tax paid by Purchaser or any Purchaser Related Party, which shall not reduce the amount of the required payment.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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SECTION 2.08. Obligation to found a subsidiary .

Purchaser is obliged to commercialize CVAC for Germany via a subsidiary with registered seat in Leipzig (Saxony) to be established as sonn as possible but no later than in 6 months after Closing.

SECTION 2.09. Closing .

Subject to the terms and conditions of this Agreement, the sale and purchase of the Purchased Assets and the assumption of the Assumed Liabilities contemplated by this Agreement (the “ Closing ”) shall take place on the Effective Date, or on such other date as the Parties may mutually agree upon. The date on which the Closing occurs is called the “ Closing Date .”

SECTION 2.10. Closing Deliveries by Seller .

At the Closing, Seller shall deliver or cause to be delivered to Purchaser:

(a) an executed counterpart of the Transfer Agreement;

(b) an executed counterpart of the CVAC Sub-License;

(c) subject to Section 2.03 and Section 5.05 , the tangible Purchased Assets by leaving them at the premises where they are located;

(d) an executed counterpart of the Know-How License;

(e) an executed counterpart of the New License;

(f) certified copies or originals of all Transferred Contracts;

SECTION 2.11. Closing Deliveries by Purchaser .

At the Closing, Purchaser shall deliver to Seller:

(a) $50,000 of the Expense Consideration by wire transfer in immediately available funds to an account designated in writing by Seller, payable within 14 days after signing of this Agreement (therefore the $50,000 of the Expense Consideration need to be available on the bank account of Seller on 26 May 2016);

(b) executed counterpart of the Transfer Agreement;

(c) executed counterpart of the CVAC Sub-License;

(d) executed counterpart of the Know-How License;

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(e) executed counterpart of the New License;

(f) appropriate resolutions approving this Agreement and the transactions contemplated hereby, certified by an appropriate party;

(g) a certificate from the Secretary of State of the State of Nevada as to Purchaser’s good standing and payment of all applicable taxes;

(h) evidence that Purchaser has collected a financing for the Purchaser amounting to a minimum of $ 100,000.00

(i) a stock certificate representing 1,980,000 shares of Series A Preferred Stock of Purchaser equivalent to nine point nine percent (9.9%) of the outstanding capital stock in the Purchaser (currently equivalent to 3,960,000 shares of Common Stock), which shares shall be duly authorized and validly issued and considered fully paid and non-assessable, with appropriate legends with a full anti-dilution protection for the first $ 20,000,000.00 equity financing raised subsequent to Closing; and

(j) an option certificate, duly executed by Purchaser, granting to Seller an option to purchase shares of Common Stock of Purchaser representing up to five percent (5%) of the issued and outstanding capital stock of Purchaser exercisable upon the next equity financing round but no later than the fourth anniversary of the Closing Date, at a purchase price equal to a 25% premium to the pre-money valuation of the Purchaser in this financing round).

ARTICLE III.

REPRESENTATIONS AND WARRANTIES OF SELLER

Seller hereby represents and warrants to Purchaser as of the Effective Date, as follows.

SECTION 3.01. Organization; Good Standing and Qualification; Authority and Binding Effect .

(a) Seller is a public limited liability company incorporated under the Australian Corporations Act 2001 (Cth) and has all necessary power and authority (i) to own, lease, and operate its properties, (ii) to carry on its business as it is now conducted, and (iii) to enter into this Agreement and each Ancillary Agreement to which it is a party, subject to consents in relation to Transferred Contracts, and to carry out its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. Seller is duly licensed or qualified to do business in all jurisdictions in which such license or qualification is required, except for those jurisdictions in which failure to do so would not have a Material Adverse Effect.

(b) The execution and delivery of this Agreement and the Ancillary Agreements by Seller, the performance by Seller of its obligations hereunder and thereunder and the consummation by Seller of the transactions contemplated hereby and thereby have been, or will have been at the Closing, duly authorized by all requisite corporate action on the part of Seller.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) This Agreement has been, and upon their execution the Ancillary Agreements to which it is a party shall have been, duly executed and delivered by Seller, and (assuming due authorization, execution and delivery by Purchaser) this Agreement constitutes, and upon their execution the Ancillary Agreements shall constitute, legal, valid and binding obligations of Seller, enforceable against Seller in accordance with their respective terms, except as such enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar Laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or at law).

SECTION 3.02. No Conflict .

Except as may result from any facts or circumstances relating solely to Purchaser, the execution, delivery and performance of this Agreement and the Ancillary Agreements by Seller to the Knowledge of Seller do not and will not (a) violate, conflict with or result in a breach of the constituent documents of Seller in any material respect, (b) result in a material conflict with or a material violation of any Law or Governmental Order applicable to Seller or the Purchased Assets or (c) conflict with, result in any material breach of, constitute a material default (or event which with the giving of notice or lapse of time, or both, would become a default) under, require any consent under, result in the creation or imposition of any Encumbrance other than Permitted Encumbrances on the Purchased Assets, or give to others any rights of termination, acceleration or cancellation (except for the Transferred Contracts) of, any note, bond, mortgage or indenture, contract, agreement, lease, sublease, license, permit, franchise or other instrument or arrangement to which Seller is a party or to which the Purchased Assets are subject, except, in the case of clauses (b) and (c), as would not materially and adversely affect the ability of Seller to carry out its obligations under, and to consummate the transactions contemplated by, this Agreement and the Ancillary Agreements

SECTION 3.03. Governmental Consents and Approvals .

The execution, delivery and performance of this Agreement and each Ancillary Agreement by Seller do not and will not require any consent, approval, authorization or other order of, action by, filing with or notification to, any Governmental Authority, except (a) where failure to obtain such consent, approval, authorization or action, or to make such filing or notification, would not (i) prevent or materially delay the consummation by Seller of the transactions contemplated by this Agreement and the Ancillary Agreements or (ii) have a material adverse effect, or (b) as may be necessary as a result of any facts or circumstances relating solely to Purchaser or any of its Affiliates, or (c) any other approvals as may be necessary under ASX Listing Rules or the Corporations Act (d) in case Purchaser does not comply with its obligation pursuant to Section 2.08 regarding the subsidy provided by Sächsische Aufbaubank to Seller with grant approval decisions on 11 March 2013.

SECTION 3.04. Litigation .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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As of the Effective Date, there is no Action pending, by or against Seller or any of its Affiliates, or to the Knowledge of Seller, threatened, before any Governmental Authority, (a) relating to the Purchased Assets or the CVAC Products or (b) which could affect the legality, validity or enforceability of this Agreement, any Ancillary Agreement or the consummation of the transactions contemplated hereby, and Seller is not aware that there is any basis for the foregoing.

SECTION 3.05. Compliance with Laws .

As of the Effective Date:

(a) Seller is in material compliance with all material Laws applicable to the ownership or operation of the Purchased Assets;

(b) Seller is in compliance in all material respects with the obligations imposed on it under the Transferred Contracts;

(c) Seller is not in violation of any material term of its constituent documents; and

(d) there are no Actions pending or, to Seller’s Knowledge, threatened which question the legality or propriety of the transactions contemplated by this Agreement or which materially impairs the ability of Seller to perform its obligations hereunder, and Seller is not aware that there is any basis for the foregoing.

SECTION 3.06. Intellectual Property .

(a) The Licensed IP constitutes all Intellectual Property legally disposable and owned by or licensed to Seller that is necessary or useful to Exploit the CVAC Products. Seller owns all right, title, and interest in and to, or has a license to use, all of the Licensed IP, free and clear of all Encumbrances, other than Permitted Encumbrances. Seller has taken reasonable measures to maintain in confidence all trade secrets and confidential information comprising a part of the Licensed IP.

(b) To the Knowledge of Seller, (i) no infringement, misappropriation, or violation of any Licensed IP, or any rights of publicity or privacy relating to the use of names, likenesses, voices, signatures or biographical information, of any other Person has occurred or results in any way from Seller’s Exploitation of the CVAC Products; (ii) no claim of any infringement, misappropriation or violation of any Licensed IP or any such rights of any other Person has been made or asserted in respect of Seller’s Exploitation of the CVAC Products; (iii) no claim of invalidity of any Licensed IP owned by Seller has been made by any other Person; (iv) no proceedings are pending, threatened that challenge the validity, enforceability, ownership or use of any Licensed IP owned by Seller; and (v) Seller has not had notice of any basis for, a claim against Seller that Seller’s Exploitation of the CVAC Products infringe, misappropriate, or violate any Intellectual Property of any other Person.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(c) To Seller’s Knowledge, all registration, maintenance and renewal fees currently due in connection with the Licensed IP have been paid and all documents, recordations and certificates in connection with the Licensed IP currently required to be filed have been filed with the relevant patent office or other authorities in Australia or foreign jurisdictions, as the case may be, for the purposes of prosecuting, maintaining and perfecting the Licensed IP.

(d) Since 31 st of Dec 2015 Seller has not brought nor been a party to any claims, suits, arbitrations or other adversarial proceedings with respect to the Licensed IP against any Third Party, nor has Seller threatened any such action against any Third Party.

(e) To the Knowledge of Seller all employees, agents, consultants or independent contractors who have contributed to or participated in the creation or development of any Seller-owned Licensed IP (i.e. CVAC Intellectual Property under the CVAC Sub-License are excluded as Burnet Institute is owner of the CVAC Intellectual Property) on behalf of Seller either: (i) created such materials in the scope of his or her employment or (ii) is a party to a “work-for-hire” agreement or similar agreement under which Seller is deemed to be the original owner/author of all rights, title and interest therein; and in either case has executed an assignment or an agreement to assign in favor of Seller (or such predecessor in interest, as applicable) of all right, title and interest in such material. To the Knowledge of Seller, no current or former employee, consultant or independent contractor of Seller has any right, title, claim or interest in, to or under any Licensed IP owned or developed by Seller that has not been exclusively assigned and transferred to Seller.

SECTION 3.07. Title; Sufficiency of Assets .

(a) Seller and/or its Affiliates have good and marketable title to all of the Purchased Assets (except for the trademarks, trade names and logos listed in the Know-How License which are owned by Prima BioMed IP Pty Ltd.), free and clear of all Encumbrances, other than Permitted Encumbrances. Except for the Excluded Assets, the Purchased Assets include all of the tangible personal properties, Intellectual Property and other assets owned or leased by Seller that are solely and exclusively related to the CVAC Products. This Section 3.07 does not relate to Intellectual Property, which is the subject of Section 3.06 .

(b) To the Knowledge of the Seller, the Purchased Assets include all the assets necessary to permit Purchaser to carry on and conduct the Exploitation of the CVAC Products in a way as conducted per today in compliance with all Laws and to perform all Assumed Liabilities.

SECTION 3.08. Taxes .

(i) Seller has timely filed (taking into account any valid extensions) all Tax Returns required to be filed relating to the Purchased Assets, all such Tax Returns are complete and accurate, and all Taxes shown to be due on such Tax Returns have been timely paid; (ii) all Taxes (whether or not shown on any Tax Return) owed by Seller relating to the Purchased Assets and required to be paid on or before the Closing Date have been or will be timely paid; (iii) Seller has not waived any statute of limitations in respect of Taxes relating to the Purchased Assets (and no request for any such waiver is currently pending); (iv) none of the Tax Returns

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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referred to in clause (i) have been examined by the IRS or the appropriate state, local or foreign Taxing Authority; (v) there is no action, suit, investigation, audit, claim or assessment pending or, to Seller’s Knowledge, proposed or threatened with respect to Taxes of Seller and no valid basis exists therefor; (vi) all material deficiencies asserted or assessments made as a result of any examination of the Tax Returns referred to in clause (i) have been paid in full; (vii) there are no liens for Taxes upon the Purchased Assets except liens relating to current Taxes not yet due; (viii) Seller has never participated in a “listed transaction” within the meaning of Treasury Regulation 1.6011-4; and (ix) Seller has not participated in a transaction which does not have economic substance within the meaning of section 7701(o) of the Code and applicable common law.

SECTION 3.09. No Brokers .

No broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement or the Ancillary Agreements based upon arrangements made by or on behalf of Seller or any of its Affiliates.

SECTION 3.10. Governmental Permits .

(a) Seller owns, holds or possesses all licenses, franchises, grants, charters, permits, privileges, immunities, approvals, easements, variances, exceptions, consents, certificates, clearances and other authorizations from Governmental Authorities which are necessary or appropriate to entitle it to own or lease, operate and use its assets and to carry on and conduct its Exploitation of the CVAC Products in a way as conducted per today (herein collectively called “ Governmental Permits ”). No violations have been recorded in respect of any Governmental Permits, and Seller is not aware that there is any basis therefor. No fines or penalties are due and payable in respect of any Governmental Permit or any violation thereof and all fees and charges with respect to such Permits have been paid in full.

SECTION 3.11. Environmental Matters .

Seller’s past and present operations with respect to the Purchased Assets have complied in all material respects, and are in compliance in all material respects, with all applicable Environmental Laws. Seller is not required by applicable Environmental Law to obtain any Governmental Permit for the conduct of Seller’s business.

SECTION 3.12. Contracts .

(a) Each of the Transferred Contracts constitutes a valid and binding obligation of the Seller and is, unless terminated in accordance with the terms and conditions provided in the applicable Transferred Contract and not as a result of a breach or default by Seller thereunder, in full force and effect, except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting the enforcement of creditors’ rights generally and by the effect of general principles of equity (regardless of whether enforcement is considered in a proceeding in equity or at law). Neither Seller nor, to Seller’s Knowledge, any other party to any Transferred Contract, is in material breach or violation of, or default under, or has repudiated any provision of, any Transferred Contract.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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SECTION 3.13. Full Disclosure .

To Seller’s Knowledge, neither this Agreement nor any of the other Ancillary Agreements, (a) contains or will contain as of the Closing Date any untrue statement of fact or (b) omits or will omit to state any material fact necessary to make any of the representations, warranties or other statements or information contained herein or therein (in light of the circumstances under which they were made) not misleading. To Seller’s Knowledge, all information regarding Seller or Seller’s properties, assets (including the Purchased Assets), operations, businesses, Liabilities, financial performance, net income and prospects that has been furnished to Purchaser or any of its Representatives by or on behalf of Seller or any of Seller’s Representatives, is accurate, correct and complete in all material respects.

SECTION 3.14. Purchase Entirely for Own Account .

The Common Shares will be acquired for investment for Seller’s own account, not as a nominee or agent, and not with a view to the resale or distribution of any part thereof, and Seller has no present intention of selling, granting any participation in, or otherwise distributing the same. By executing this Agreement, Seller further represents that Seller does not presently have any contract, undertaking, agreement or arrangement with any Person to sell, transfer or grant participations to such Person or to any Third Party, with respect to any of the Common Shares. Seller has not been formed for the specific purpose of acquiring the Common Shares. Seller acknowledges that this Agreement is made with Seller in reliance upon the foregoing representations, which by Seller’s execution of this Agreement, Seller hereby confirms.

SECTION 3.15. Disclosure of Information .

Seller has had an opportunity to discuss Purchaser’s business, management, financial affairs and the terms and conditions of the offering of the Common Shares with Purchaser’s management and has had an opportunity to review Purchaser’s facilities.

SECTION 3.16. Restricted Securities .

Seller understands that the Common Shares have not been, and will not be, registered under the Securities Act, by reason of a specific exemption from the registration provisions of the Securities Act which depends upon, among other things, the bona fide nature of the investment intent and the accuracy of Seller’s representations as expressed herein. Seller understands that the Common Shares are “restricted securities” under applicable U.S. federal and state securities laws and that, pursuant to these laws, Seller must hold the Common Shares indefinitely unless they are registered with the Securities and Exchange Commission and qualified by state authorities, or an exemption from such registration and qualification requirements is available. Seller acknowledges that Purchaser has no obligation to register or qualify the Common Shares for resale. Seller further acknowledges that if an exemption from registration or qualification is available, it may be conditioned on various requirements

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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including, but not limited to, the time and manner of sale, the holding period for the Common Shares, and on requirements relating to Purchaser which are outside of Seller’s control, and which Purchaser is under no obligation and may not be able to satisfy. The Purchaser and Seller agree to negotiate, in good faith, customary registration rights with respect to the Common Shares held by the Seller upon commercialization of a Covered Product.

SECTION 3.17. Legends .

Seller acknowledges that the Common Shares shall bear legends reflecting appropriate restrictions on transfer as described herein.

SECTION 3.18. Accredited Investor .

Seller is an accredited investor as defined in Rule 501(a) of Regulation D promulgated under the Securities Act.

SECTION 3.19. No Other Representations or Warranties .

EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THIS ARTICLE III , NEITHER SELLER, ITS AFFILIATES NOR ANY OTHER PERSON MAKES ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY ON BEHALF OF SELLER. SUBJECT TO THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THIS ARTICLE III , PURCHASER HEREBY ACKNOWLEDGES AND AGREES THAT PURCHASER IS PURCHASING THE PURCHASED ASSETS IN AN “AS IS” AND “WHERE IS” BASIS AND IN RELIANCE ON ONLY THOSE REPRESENTATIONS AND WARRANTIES OF SELLER EXPRESSLY SET FORTH IN THIS ARTICLE III .

ARTICLE IV.

REPRESENTATIONS AND WARRANTIES OF PURCHASER

Purchaser hereby represents and warrants to Seller as of the Effective Date as follows:

SECTION 4.01. Organization and Authority of Purchaser .

(a) Purchaser is a corporation duly formed, validly existing and in good standing under the laws of Nevada and has all necessary power and authority (i) to own, lease, and operate its properties, (ii) to carry on its business as it is now conducted, and (iii) to enter into this Agreement and each Ancillary Agreement to which it is a party, to carry out its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. Purchaser is duly licensed or qualified to do business in all jurisdictions in which such license or qualification is required, except for those jurisdictions in which failure to do so would not have a material adverse effect.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) The execution and delivery of this Agreement and the Ancillary Agreements by Purchaser, the performance by Purchaser of its obligations hereunder and thereunder and the consummation by Purchaser of the transactions contemplated hereby and thereby have been, or will have been at the Closing, duly authorized by all requisite corporate action on the part of Purchaser.

(c) This Agreement has been, and upon their execution the Ancillary Agreements to which it is a party shall have been, duly executed and delivered by Purchaser, and (assuming due authorization, execution and delivery by Seller) this Agreement constitutes, and upon their execution the Ancillary Agreements shall constitute, legal, valid and binding obligations of Purchaser, enforceable against Purchaser in accordance with their respective terms, except as such enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar Laws affecting creditors’ rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or at law).

SECTION 4.02. No Conflict .

Except as may result from any facts or circumstances relating solely to Seller, the execution, delivery and performance of this Agreement and the Ancillary Agreements by Purchaser do not and will not (a) violate, conflict with or result in the breach of the certificate of incorporation of Purchaser, (b) conflict with or violate any Law or Governmental Order applicable to Purchaser or (c) require any consent under any contract, except, in the case of clauses (b) and (c), as would not materially and adversely affect the ability of Purchaser to carry out its obligations under, and to consummate the transactions contemplated by, this Agreement and the Ancillary Agreements.

SECTION 4.03. Governmental Consents and Approvals .

The execution, delivery and performance by Purchaser of this Agreement and each Ancillary Agreement to which Purchaser is a party do not and will not require any consent, approval, authorization or other order of, action by, filing with, or notification to, any Governmental Authority, except (a) where failure to obtain such consent, approval, authorization or action, or to make such filing or notification, would not prevent or materially delay the consummation by Purchaser of the transactions contemplated by this Agreement and the Ancillary Agreements or have a material adverse effect, or (b) as may be necessary as a result of any facts or circumstances relating solely to Seller or any of its Affiliates.

SECTION 4.04. Litigation .

As of the Effective Date, there is no Action, by or against Purchaser or any of its Affiliates, or to the Knowledge of Purchaser, threatened in writing, before any Governmental Authority, which could affect the legality, validity or enforceability of this Agreement, any Ancillary Agreement or the consummation of the transactions contemplated hereby.

SECTION 4.05. No Brokers .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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No broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement based upon arrangements made by or on behalf of Purchaser or any of its Affiliates.

SECTION 4.06. Capitalization .

(a) Schedule 4.06(a) sets forth, as of the Closing Date, with respect to Purchaser, (i) the number of authorized shares of each class of its capital stock, (ii) the number of issued and outstanding shares of each class of its capital stock and (iii) the number of shares of each class of its capital stock which are held in treasury.

(b) All of the issued and outstanding shares of capital stock of Purchaser, including the shares of Common Stock issued to Seller at the Closing, (i) have been duly authorized and validly issued and are fully paid and non-assessable, (ii) were issued in compliance with all applicable state and federal securities Laws and (iii) were not issued in violation of any preemptive rights or rights of first refusal.

(c) No preemptive rights, right of first refusal or similar rights exist with respect to the shares of capital stock of Purchaser, and no such rights arise or become exercisable by virtue of or in connection with the transactions contemplated by this Agreement; (ii) there are no outstanding or authorized rights, options, warrants, convertible securities, subscription rights, conversion rights, exchange rights or other agreements or commitments of any kind that could require Purchaser to issue or sell any shares of its capital stock (or securities convertible into or exchangeable for shares of its capital stock); (iii) there are no outstanding stock appreciation, phantom stock, profit participation or other similar rights with respect to Purchaser; and (iv) there are no proxies, voting rights or other agreements or understandings with respect to the voting or transfer of the capital stock of Purchaser.

ARTICLE V.

ADDITIONAL COVENANTS

SECTION 5.01. Confidentiality .

From and after the Closing, Seller and Purchaser will treat and hold as confidential, and not use or disclose any of the Confidential Information to any Person, except to pursue its rights under this Agreement or the Ancillary Agreements or as required by Law or the rules of a stock exchange. In the event that Seller or Purchaser are requested or required (by oral question or request for information or documents in any legal proceeding, interrogatory, subpoena, civil investigative demand or similar process or as otherwise required by Law) to disclose any Confidential Information, Seller will notify Purchaser (or vice versa) promptly of the request or requirement, as far in advance of such disclosure as practicable, so that Purchaser or Seller may seek an appropriate protective order or waive compliance with the provisions of this Section 5.01 . If, in the absence of a protective order or the receipt of a waiver hereunder, Seller or Purchaser are compelled to disclose any Confidential Information to any Governmental Authority or else stand liable for contempt, Seller or Purchaser may disclose such Confidential Information to the Governmental Authority; provided , however , that Seller or Purchaser shall use

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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commercially reasonable efforts to obtain an order or other assurance that confidential treatment will be accorded to such portion of the Confidential Information required to be disclosed. For the purposes of this Agreement, “ Confidential Information ” shall mean any nonpublic or confidential information relating to the Purchased Assets, the Know-How License and the CVAC Sub-License, except to the extent that such information shall have become available to the public other than through improper disclosure by Seller or Purchaser or anyone acting by, through or under Seller or Purchaser.

SECTION 5.02. Condition of the Purchased Assets .

(a) Purchaser has made all inspections and investigations of the Purchased Assets deemed necessary or desirable by Purchaser. Purchaser acknowledges and agrees that (a) it is purchasing the Purchased Assets based on the results of such inspections and investigations and not on any representations and warranties of Seller or any its Affiliates other than as expressly set forth in this Agreement or the certificates and other documents delivered pursuant hereto, including the Ancillary Agreements, (b) the Purchased Assets are sold “as is, where is” and Purchaser accepts the Purchased Assets in the condition they are in and at the place where they are located on the Closing Date and (c) the drug substances included in the Inventory are only bulk drug substance and do not include any finished products. In light of such inspections and investigations, and the representations and warranties expressly made to Purchaser by Seller in this Agreement, the Ancillary Agreements and the certificates and other documents delivered pursuant hereto, PURCHASER ACKNOWLEDGES THAT THE REPRESENTATIONS AND WARRANTIES GIVEN HEREIN BY SELLER ARE IN LIEU OF, AND PURCHASER HEREBY EXPRESSLY WAIVES ALL RIGHTS TO, ANY IMPLIED WARRANTIES THAT MAY OTHERWISE BE APPLICABLE BECAUSE OF THE PROVISIONS OF THE UNIFORM COMMERCIAL CODE OR ANY OTHER LAWS, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE .

(b) Any claims that Purchaser may have for breach of representations and warranties shall be based solely on the representations and warranties set forth in this Agreement and the certificates and other documents delivered pursuant hereto.

(c) Purchaser further acknowledges that neither Seller, its Affiliate, nor any other Person, has made any representation or warranty, express or implied, as to the accuracy or completeness of any information regarding Seller, the Purchased Assets or the Assumed Liabilities not expressly set forth in this Agreement or the certificates or other documents delivered pursuant hereto.

SECTION 5.03. Bulk Transfer Laws .

Purchaser hereby waives compliance by Seller with any applicable bulk sale or bulk transfer Laws of any jurisdiction in connection with the sale of the Purchased Assets to Purchaser; provided , however , that Seller agrees (a) to pay and discharge when due or to contest or litigate all claims of creditors that are asserted against Purchaser or the Purchased Assets by reason of such noncompliance, (b) to indemnify, defend and hold harmless Purchaser from and

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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against any and all such claims in the manner provided in Article VI and (c) to take promptly all necessary action to remove any Encumbrance that is placed on the Purchased Assets by reason of such noncompliance.

SECTION 5.04. Further Action .

The Parties shall use their best efforts to take, or cause to be taken, all appropriate action, to do or cause to be done all things necessary, proper or advisable under applicable Law, and to execute and deliver such documents, as may be required to carry out the provisions of this Agreement and consummate and make effective the transactions contemplated by this Agreement.

SECTION 5.05. Transfer of Books and Records .

Seller shall use commercially reasonable efforts to transfer to Purchaser on the Closing Date the Transferred Books and Records that are (a) located at Seller’s facilities, (b) reasonably identifiable and reasonably separable from other books and records of Seller. To the extent that Seller is unable to transfer any such Transferred Books and Records on the Closing Date, Seller shall use commercially reasonable efforts to deliver or make available through electronic access to Seller’s online database, such Transferred Books and Records to Purchaser as soon as reasonably practicable after the Closing Date; provided , however , that Seller’s obligations under this Section 5.05 shall expire on the first (1 st ) anniversary of the Closing Date. Seller shall, when reasonably available, transfer originals of the Transferred Books and Records, and otherwise may transfer copies of the Transferred Books and Records.

SECTION 5.06. Seller’s Post-Closing Obligations with respect to Licensed IP .

After the Closing Date, Seller agrees as follows:

(a) Seller shall, without further consideration or compensation, communicate to Purchaser any facts of which Seller has knowledge with respect to the Licensed IP, testify in any legal proceeding, sign all documents, make all rightful oaths and declarations, to the extent necessary to aid Purchaser in obtaining the full benefit of its rights in respect of the Licensed IP that are granted under this Agreement and the Ancillary Agreements. Purchaser agrees to reimburse Seller’s reasonable out-of-pocket expenses in carrying out its obligations under this section.

(b) Seller agrees not to take any action challenging or opposing, on any grounds whatsoever, Purchaser’s rights in the Licensed IP, or the validity thereof.

SECTION 5.07. Patent Maintenance .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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From Closing, as between Seller and Purchaser, Purchaser will assume sole responsibility and expense for all further prosecution and maintenance of all Licensed IP if and to the extent not to be borne by Burnet Institute pursuant to the CVAC Sub-License.

SECTION 5.08. Continuing Involvement .

To facilitate the transfer of the Purchased Assets from Seller to Purchaser under this Agreement, Dr. Sharon Gargosky shall become a member of the management of Purchaser. Purchaser shall pay Dr. Gargosky’s consulting fees.

SECTION 5.09. Stock .

Purchaser will authorize and reserve for issuance such number of shares of Common Stock as reasonably necessary to effectuate the anti-dilution provisions under Section 2.06(b)(ii) (from time to time as such number becomes determinable).

SECTION 5.10. Transferred Books and Records .

(a) Purchaser acknowledges and agrees that (i) Seller may retain copies of the Transferred Books and Records (A) in connection with the performance of Seller’s obligations under any agreement effective prior to the Closing Date to which Seller is a party, (B) as required to satisfy its ongoing obligations with relevant Government Authorities, (C) to make any required filings, (D) to respond to any potential inquiry or audit with any Government Authority or (E) for the use in accordance with Section 6.03(c) and (ii) Seller may retain a copy of all financial records of Seller and its Affiliates and any other Transferred Books and Records to the extent necessary for Tax, accounting or litigation purposes.

(b) For a period of five (5) years after the Closing Date, and except as prohibited by any applicable Law, upon the reasonable request of Seller and at Seller’s sole expense, Purchaser shall provide Seller and its representatives with reasonable access to and the right to make copies of the Transferred Books and Records, to the extent the possession of which is retained by Purchaser, as may be necessary or useful in connection with any Third Party litigation, the preparation of financial statements, the conduct of any audit or investigation by a Governmental Authority, or any similar or related matter. If during such period, Purchaser elects to dispose of such records and documents (other than in connection with a sale or all or substantially all of Purchaser’s business or assets or other assignment of Purchaser’s rights hereunder pursuant to Section 8.06 ), Purchaser shall give Seller sixty (60) days’ prior written notice, during which period Seller shall have the right to take such records and documents without further consideration, except as prohibited by any applicable Law.

(c) For a period of five (5) years after the Closing Date, and except as prohibited by any applicable Law, upon the reasonable request of Purchaser and at Purchaser’s sole expense, Seller shall provide Purchaser and its representatives with reasonable access to and the right to make copies of all books, files, papers, correspondence, documents, databases, software, reports, laboratory notebooks, plans and records in Seller’s possession that are related to the CVAC Products, Purchased Assets and Assumed Liabilities that are not transferred to Purchaser pursuant to Section 6.06 (the “ Retained Books and Records ”), as may be necessary or

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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useful in connection with the Exploitation of any CVAC Products, any Third Party litigation, the preparation of financial statements, the conduct of any audit or investigation by a Governmental Authority, or any similar or related matter.

SECTION 5.11. Noncompetition Agreement .

(a) For and in consideration of the transactions contemplated herein, during the period commencing with the Closing Date and ending on the earlier of (i) the fifth anniversary of the Closing Date or (ii) the date of the occurrence of an event pursuant to Section 6.03 sentence 1 , Seller shall not engage in any “Competitive Activity” (as defined below).

(b) “ Competitive Activity ” means directly or indirectly (or having any interest in, or performing any services for, any Person directly or indirectly) engaging in the development and distribution of any CVAC Product or New CVAC Product in the field of cancer treatment.

(c) Notwithstanding the foregoing, the provisions of this Section 5.11 shall not prevent Seller from beneficially owning up to five percent (5%), on a fully-diluted basis, of the total shares of all classes of stock outstanding of any corporation having securities listed or traded on a stock exchange.

(d) It is the understanding of the Parties that the scope of the covenants contained in this Section 5.11 , both as to time and area covered, are necessary to protect the rights of Purchaser and the goodwill that is a part of the Business of Seller to be acquired by Purchaser. It is the Parties’ intention that these covenants be enforced to the greatest extent (but to no greater extent) in time, area and degree of participation as is permitted by the law of that jurisdiction whose law is found to be applicable to any acts in breach of these covenants. It being the purpose of this Agreement to govern competition by Seller in the Restricted Territory, these covenants shall be governed by and construed according to that law (from among those jurisdictions arguably applicable to this Agreement and those in which a breach of this Agreement is alleged to have occurred or to be threatened) which best gives them effect. The prohibitions in subsection (a) of this Section 5.11 shall be deemed, and shall be construed, as separate and independent agreements between Purchaser on the one hand, and Seller, respectively, on the other. If such agreement or any part of such agreement is held invalid, void or unenforceable by any court of competent jurisdiction, such invalidity, voidness or unenforceability shall in no way render invalid, void or unenforceable any other part of them or any separate agreement not declared invalid, void or unenforceable; and this Agreement shall in such case be construed as if the invalid, void or unenforceable provisions were omitted.

(e) The Parties agree that the covenants of Seller not to compete contained in this Section 5.11 may be assigned by Purchaser to any Person to whom the whole Business of Seller may be transferred by the sale or transfer of their business and assets or otherwise. It is the Parties’ intention that these covenants of Seller shall inure to the benefit of any Person that may succeed to the whole Business, the CVAC Sub-License, the Know-How License and Purchased Assets of Seller (as acquired by Purchaser under this Agreement) with the same force and effect as if these covenants were made directly with such successor.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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ARTICLE VI.

PURCHASER OBLIGATION TO COMMERCIALISE

SECTION 6.01.

Purchaser shall, and shall cause Purchaser Related Parties, to use Commercially Reasonable Efforts to obtain Regulatory Approval for, and to commercialize, at least one (1) Covered Product in the United States.

SECTION 6.02.

In particular in one of the following events, Purchaser shall be incontestably deemed to be in breach of its foregoing obligation:

(a) Purchaser becomes Bankrupt;

(b) a Purchaser Related Party becomes Bankrupt, unless all rights to the Purchased Assets or any Covered Product acquired by the Purchaser Related Party (including rights under the CVAC Sub-License and the Know-How License) under an Agreement pursuant to Section 2.07(f ) above have retransferred in their entirety to Purchaser within a period of three months after the Purchaser Related Party having become Bankrupt;

(c) an twenty-four-months-period, having commenced at any time after the Closing Date, has lapsed during which no clinical study – initiated by Purchaser or a Purchaser Related Party – for a Covered Product has been active, unless Regulatory Approval for at least one (1) Covered Product in the United States has been obtained before or during such period;

(d) Purchaser was not able to collect a financing for the development of CVAC in the amount of at least $2,000,000 within a period of six months following the Closing Date.

SECTION 6.03.

In the event of a breach of Purchaser’s obligation pursuant to Section 6.01 above (including a deemed breach pursuant Section 6.02 above) by Purchaser or in the event of any other termination for cause by Seller of the CVAC Sub-Licensed and/or the Know-How License, Purchaser shall be obliged to put Seller in a position which enables Seller (under exclusion of Purchaser and any Purchaser Related Parties) to resume its own activities to develop, obtain Regulatory Approval, commercialize and Exploit CVAC, the CVAC Products, the CVAC License, the Licensed Know-How and any other Covered Product by itself or together with, or via any, Affiliates or Third Parties. Such obligation shall in particular include the following without Seller owing any compensation:

(a) Seller shall have the right to terminate the CVAC Sub-License and the Know-How License for good cause with immediate effect (to be reflected in the further terms of the CVAC Sub-License and the Know-How License);

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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(b) Purchaser shall be obliged to retransfer the Purchased Assets to the Seller; Section 2.05 shall apply accordingly;

(c) Seller shall have the right to retain copies of the Transferred Books and Records for the free use in accordance with this Section 6.03 , provided that an event pursuant to Section 6.03 sentence 1 has occurred;

(d) Purchaser herewith grants a transferable non-exclusive license to Seller for patents and patent applications held and filed by Purchaser, respectively, know-how Controlled by Purchaser and documentation in Purchaser’s possession, in each case related to the Covered Products in accordance with Exhibit D (the “ New License ”) on the basis of the mutual understanding of the Parties, and a corresponding undertaking of the Seller, that Seller shall not be entitled to make use of such New License, unless, and up until, an event pursuant to Section 6.03 has occurred;

(e) The noncompetition agreement pursuant to Section 5.11 shall terminate with immediate effect, and Seller shall have no further obligations or restrictions thereunder, upon the occurrence of an event pursuant to this Section 6.03 sentence 1 .

ARTICLE VII.

INDEMNIFICATION

SECTION 7.01. Survival of Representations and Warranties .

The representations and warranties of the Parties contained in this Agreement and the Ancillary Agreements shall survive the Closing until the date which is two (2) years after the Closing; provided, however, that the representations and warranties set forth in Section 3.08 (Taxes) and Section 3.11 (Environmental Matters) shall survive the Closing until the expiration of the applicable statute of limitations (giving effect to any waiver, mitigation or extension thereof), plus a period of forty-five (45) days. Each Indemnified Party must give written notice to the respective Indemnifying Party of any claim for indemnification under this Article VII in accordance with Section 7.05 . Any claim for indemnification made in writing by the Indemnified Party on or prior to the expiration of the applicable survival period shall survive, and may continue to be asserted and indemnified against, until such claim is finally and fully resolved. All of the covenants and other agreements of the Parties contained in this Agreement shall survive until fully performed or fulfilled.

SECTION 7.02. Indemnification by Seller .

Purchaser (each, a “ Purchaser Indemnified Party ”) shall be indemnified, defended and held harmless by Seller, from and against any and all Losses arising out of or resulting from: (a) the material breach or violation of or inaccuracy in any representation or warranty made by Seller contained in this Agreement or any Ancillary Agreement; (b) the material breach or violation of any covenant or agreement of Seller contained in this Agreement or any Ancillary Agreement; and (c) any Third Party Claim based upon, resulting from or arising out of the business, operations, properties, assets or obligations of Seller or any of its Affiliates (other than the Purchased Assets or Assumed Liabilities) conducted, existing or arising on or prior to the Closing Date.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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SECTION 7.03. Indemnification by Purchaser .

Seller and its Affiliates, officers, directors, employees, agents, stockholders, attorneys, representatives, successors and assigns (each, a “ Seller Indemnified Party ”) shall be indemnified, defended and held harmless by Purchaser from and against any and all Losses arising out of or resulting from: (a) the breach or violation of or inaccuracy in any representation or warranty made by Purchaser contained in this Agreement or any Ancillary Agreement; (b) the breach or violation of any covenant or agreement of Purchaser contained in this Agreement or any Ancillary Agreement; and (c) the Assumed Liabilities.

SECTION 7.04. Limits on Indemnification .

Notwithstanding anything to the contrary contained in this Agreement, (i) an Indemnifying Party shall not be liable for any Losses for indemnification pursuant to Section 7.02(a) or Section 7.03(a) unless such Losses exceeds $25,000 (the “ Indemnity Basket ”). If the aggregate amount of all such Losses exceed the Indemnity Basket, the Indemnified Party shall be indemnified, subject to the provisions of ARTICLE VII , for the amount of such Losses that are in excess of the Indemnity Basket; and (ii) the maximum amount of indemnifiable Losses which may be recovered from an Indemnifying Party pursuant to Section 7.02 or Section 7.03(a) shall be an amount equal to amounts that were paid by Purchaser to Seller under Section 2.06 and Section 2.07 hereof. The amount of any Losses for which indemnification is provided under this Article IV shall be net of any amounts actually recovered by the Indemnified Party under insurance policies with respect to such Losses (net of the present value of any increase in premiums actually imposed by the applicable insurance carrier as a result of the occurrence of the Loss and all costs and expenses incurred in recovering such insurance proceeds with respect to such Loss). Anything herein to the contrary notwithstanding, no claim for indemnification for a breach of a particular representation, warranty or covenant shall be made after the Closing if the Purchaser had Knowledge of such breach as of the Closing.

SECTION 7.05. Notice of Loss; Third Party Claims .

(a) A claim for indemnification for any matter not involving a Third Party Claim may be asserted by written notice to the Party from whom indemnification is sought. Any Action by an Indemnified Party on account of a Loss which does not result from a Third Party Claim (a “ Direct Claim ”) shall be asserted by the Indemnified Party giving the Indemnifying Party reasonably prompt written notice thereof, but in any event not later than thirty (30) days after the Indemnified Party becomes aware of such Direct Claim. The failure to give such prompt written notice shall not, however, relieve the Indemnifying Party of its indemnification obligations, except and only to the extent that the Indemnifying Party forfeits rights or defenses by reason of such failure. Such notice by the Indemnified Party shall describe the Direct Claim in reasonable detail, shall include copies of all material written evidence thereof and shall indicate the estimated amount, if reasonably practicable, of the Loss that has been or may be sustained by the Indemnified Party. The Indemnifying Party shall have thirty (30) days after its

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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receipt of such notice to respond in writing to such Direct Claim. The Indemnified Party shall allow the Indemnifying Party and its professional advisors to investigate the matter or circumstance alleged to give rise to the Direct Claim, and whether and to what extent any amount is payable in respect of the Direct Claim and the Indemnified Party shall assist the Indemnifying Party’s investigation by giving such information and assistance (including access to the Indemnified Party’s premises and personnel and the right to examine and copy any accounts, documents or records) as the Indemnifying Party or any of its professional advisors may reasonably request. If the Indemnifying Party does not so respond within such thirty (30) day period, the Indemnifying Party shall be deemed to have rejected such claim, in which case the Indemnified Party shall be free to pursue such remedies as may be available to the Indemnified Party upon the terms and subject to the conditions of this Agreement.

(b) In the event that any Action shall be instituted or that any claim or demand shall be asserted by any Third Party in respect of which payment may be sought under Section 7.02 or Section 7.03 hereof (regardless of the limitations set forth in Section 7.04 ) (each, a “ Third Party Claim ”), the Indemnified Party shall promptly cause written notice of the assertion of any Third Party Claim of which it has knowledge which is covered by this indemnity to be forwarded to the Indemnifying Party. The failure of the Indemnified Party to give reasonably prompt notice of any Third Party Claim shall not release, waive or otherwise affect the Indemnifying Party’s obligations with respect thereto except to the extent that the Indemnifying Party is actually prejudiced as a result of such failure. The Indemnifying Party shall have the right, at its sole option and expense, to be represented by counsel reasonably acceptable to the Indemnified Party and to defend against, negotiate, settle or otherwise deal with any Third Party Claim which relates to any Losses indemnified by it hereunder; provided , however , that the Indemnifying Party may not assume control of defense to a Third Party Claim (i) involving criminal liability or in which equitable relief other than monetary damages is sought, (ii) involving a purported class action, (iii) if the Indemnifying Party has not notified the Indemnified Party in writing that it will be liable to indemnify the Indemnified Party with respect to all Losses relating to such Third Party Claim subject to the limitations of Section 7.04 or (iv) if the Third Party Claim relates to Taxes or to the Licensed IP. If the Indemnifying Party elects to defend against, negotiate, settle or otherwise deal with any Third Party Claim which relates to any Losses indemnified by it hereunder, it shall within thirty (30) days (or sooner, if the nature of the Third Party Claim so requires) notify the Indemnified Party of its intent to do so. If the Indemnifying Party elects not to defend against, negotiate, settle or otherwise deal with any Third Party Claim which relates to any Losses indemnified against hereunder, or is not permitted to assume the defense of a Third Party Claim pursuant to the proviso to the third sentence of this Section 7.05(b) , the Indemnified Party may defend against, negotiate, settle or otherwise deal with such Third Party Claim, subject to the provisions below. If the Indemnifying Party shall assume the defense of any Third Party Claim pursuant to the terms of this Agreement, the Indemnified Party may participate, at his or its own expense, in the defense of such Third Party Claim; provided , however , that such Indemnified Party shall be entitled to participate in any such defense with separate counsel at the expense of the Indemnifying Party if (i) so requested by the Indemnifying Party to participate or (ii) in the reasonable opinion of outside counsel to the Indemnified Party a conflict or potential conflict exists between the Indemnified Party and the Indemnifying Party that would make such separate representation advisable; and provided , further , that the Indemnifying Party shall not be required to pay for more than one such counsel for all Indemnified Parties in connection with any

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Third Party Claim. The Parties hereto agree to reasonably cooperate with each other in connection with the defense, negotiation or settlement of any such Third Party Claim. Notwithstanding anything in this Section 7.05 to the contrary, neither the Indemnifying Party nor the Indemnified Party shall, without the written consent of the other Party, settle or compromise any Third Party Claim or permit a default or consent to entry of any judgment unless (i) the claimant provides to such other Party an unqualified release of the Indemnified and Indemnifying Parties from all liability in respect of such Third Party Claim, (ii) such settlement does not involve any injunctive relief binding upon the Indemnified Party or any of its Affiliates, (iii) such settlement does not encumber any of the material assets of any Indemnified Party or impose any restriction or condition that would apply to or materially affect any Indemnified Party or the conduct of any Indemnified Party’s business and (iv) such settlement does not involve any admission of liability or wrongdoing by any Indemnified Party or any of its Affiliates. Notwithstanding the foregoing, if a settlement offer solely for money damages is made by the applicable Third Party claimant, and the Indemnifying Party notifies the Indemnified Party in writing of the Indemnifying Party’s willingness to accept the settlement offer and, subject to the applicable limitations of Section 7.04 , pay the amount called for by such offer, and the Indemnified Party declines to accept such offer, the Indemnified Party may continue to contest such Third Party Claim, free of any participation by the Indemnifying Party, and the amount of any ultimate liability with respect to such Third Party Claim that the Indemnifying Party has an obligation to pay hereunder shall be limited to the lesser of (x) the amount of the settlement offer that the Indemnified Party declined to accept or (y) the aggregate Losses of the Indemnified Party with respect to such Third Party Claim.

(c) In the event that the Indemnified Party conducts the defense of the Third Party Claim pursuant to this Section 7.05 , the Indemnifying Party will (i) advance the Indemnified Party promptly and periodically for the reasonable costs of defending against the Third Party Claim (including reasonable attorneys’ fees and expenses) and (ii) remain responsible for any and all other Losses that the Indemnified Party may incur or suffer resulting from, arising out of, relating to, in the nature of or caused by the Third Party Claim to the fullest extent provided in this Article VII .

SECTION 7.06. Tax Treatment .

To the extent permitted by Law, the Parties agree to treat all payments made under this Article VII , under any other indemnity provision contained in this Agreement, and for any misrepresentations or breach of warranties or covenants, as adjustments to the Expense Consideration for all Tax purposes.

SECTION 7.07. Effect of Investigation .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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The representations, warranties and covenants of the Indemnifying Party, and the Indemnified Party’s right to indemnification with respect thereto, shall be affected or deemed waived by reason of any investigation made by or on behalf of the Indemnified Party (including by any of its representatives) or by reason of the fact that the Indemnified Party or any of its representatives knew or should have known that any such representation or warranty is, was or might be inaccurate.

SECTION 7.08. Remedies .

Except from claims arising from fraud, negligence, intentional misrepresentation, criminal activity or willful misconduct in connection with this Agreement, the Ancillary Agreements or the transactions contemplated hereby or thereby, from and after the Closing, except as specifically provided herein, the sole and exclusive remedy of any Indemnified Party for any breach or failure to be true and correct, or alleged breach or failure to be true and correct, of any representation, warranty covenant, agreement or obligation in this Agreement or the Ancillary Agreements, shall be indemnification in accordance with this Article VII . In furtherance of the foregoing, each of the Parties hereby waives, to the fullest extent permitted by applicable Law, any and all other rights, claims and causes of action (including rights of contributions, if any) known or unknown, foreseen or unforeseen, which exist or may arise in the future, that it may have against any Indemnifying Party with respect to this Agreement, the Ancillary Agreements or the transactions contemplated hereby or thereby, arising under or based upon any federal, state or local Law. Notwithstanding the foregoing, this Section 7.08 shall not operate to limit the rights of the Parties to seek equitable remedies (including specific performance or injunctive relief) or any remedies available to it under applicable Law in the event of a Party’s failure to comply with its indemnification obligations hereunder.

ARTICLE VIII.

GENERAL PROVISIONS

SECTION 8.01. Expenses .

Except as otherwise specified in this Agreement, all costs and expenses, including fees and disbursements of counsel, financial advisors and accountants, incurred in connection with this Agreement and the transactions contemplated by this Agreement shall be paid by the Party incurring such costs and expenses, whether or not the Closing shall have occurred.

SECTION 8.02. Notices .

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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All notices and other communications hereunder shall be in writing and shall be deemed duly delivered (i) four (4) Business Days after being sent by registered or certified mail, return receipt requested, postage prepaid, (ii) one (1) Business Day after being sent for next Business Day delivery, fees prepaid, via a reputable nationwide overnight courier service or (iii) on the date of confirmation of receipt (or, the first (1 st ) Business Day following such receipt if the date of such receipt is not a Business Day) of transmission by facsimile or email, in each case to the intended recipient as set forth below:

(a) if to Seller:

Prima Biomed LTD

Level 12, 95 Pitt Street Sydney 2000, NSW, Australia

Attn: Mr Marc Voigt (CEO)

Facsimile: +61 2 8569 1880

E-mail: marc.voigt@primabiomed.com.au

(b) if to Purchaser:

Sydys Corporation

135 East 57 th Street

24 th Floor

New York, NY 10022

Email: hernandez_joe@yahoo.com

Telephone: 646-612-4000

Attention: Joseph Hernandez

with a copy to:

Thompson Hine LLP

335 Madison Avenue, 12th Floor

New York, NY 10017

Facsimile: (212) 344-6101

Email: Faith.Charles@ThompsonHine.com

Telephone: (212) 908-3905

Attention: Faith L. Charles

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

44


Any Party to this Agreement may change the address to which notices and other communications hereunder are to be delivered by giving the other Party notice in the manner herein set forth.

SECTION 8.03. Public Announcements .

From the Effective Date through the Closing Date and thereafter, no public release or announcement concerning the transactions contemplated hereby shall be issued by any Party without the prior written consent of both Purchaser and Seller (which consent shall not be unreasonably withheld or delayed), except as such release or announcement may be required by law or the rules or regulations of any United States or foreign securities exchange, in which case the party required to make the release or announcement shall allow the other party reasonable time to comment on such release or announcement in advance of such issuance.

SECTION 8.04. Severability .

If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any Law or public policy, all other terms and provisions of this Agreement shall nevertheless remain in full force and effect for so long as the economic or legal substance of the transactions contemplated by this Agreement is not affected in any manner materially adverse to either Party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the transactions contemplated by this Agreement are consummated as originally contemplated to the greatest extent possible.

SECTION 8.05. Entire Agreement .

This Agreement and the Ancillary Agreements constitute the entire agreement of the Parties with respect to the subject matter hereof and thereof and supersede all prior agreements and undertakings, both written and oral, between Seller and Purchaser with respect to the subject matter hereof and thereof.

SECTION 8.06. Assignment .

Other than as set forth in Section 6.03(b) with respect to the possible re-assignment of Purchased Assets under this Agreement to Seller, neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, except that a Party may make such an assignment without the other Party’s consent to Affiliates or to an entity that acquires all or substantially all of the assets of such Party to which this Agreement pertains, whether in a merger, consolidation, reorganization, acquisition, sale or otherwise, so long as such entity shall assume (expressly in writing or by operation of law) the performance of all of the terms of this Agreement. Notwithstanding the foregoing, Purchaser shall provide written notice to Seller of any proposed acquisition by a Third Party of all or substantially all of the assets of Purchaser to which this Agreement pertains sufficiently in advance of any such acquisition as to allow Seller a reasonable opportunity to make a counteroffer to such Third Party acquisition. This Agreement will be binding on the

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

45


successors and assigns of the assigning Party, and the name of a Party appearing herein will be deemed to include the name(s) of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment or attempted assignment by either Party in violation of the terms of this Section will be null and void and of no legal effect. The assigning Party will forward to the other Party a copy of those portions of each fully executed assignment agreement that relate to the assumption of the rights and responsibilities of the assigning Party, within sixty (60) days of the execution of such assignment agreement.

SECTION 8.07. Performance by Purchaser Related Parties .

The Parties acknowledge that obligations under this Agreement may be performed by Affiliates of Purchaser. Purchaser guarantees performance of this Agreement by its Affiliates, notwithstanding any assignment to Affiliates in accordance with Section 8.06 of this Agreement. Wherever in this Agreement the Parties delegate responsibility to Affiliates or local operating entities, the Parties agree that the Affiliates/entities may not make decisions inconsistent with this Agreement, nor amend the terms of this Agreement or act contrary to its terms in any way. In case any Affiliate of a Party materially breaches this Agreement, the non-breaching Party will have the right to bring a cause of action directly against the other Party whether or not its Affiliate is named as a defendant in that action.

SECTION 8.08. Amendment .

This Agreement may not be amended or modified except (a) by an instrument in writing signed by, or on behalf of, the Parties hereto or (b) by a waiver in accordance with Section 8.09 .

SECTION 8.09. Waiver .

Either Party may (a) extend the time for the performance of any of the obligations or other acts of the other Party, (b) waive any inaccuracies in the representations and warranties of the other Party contained herein or in any document delivered by the other Party pursuant hereto or (c) waive compliance with any of the agreements of the other Party or conditions to such Party’s obligations contained herein. Any such extension or waiver shall be valid only if set forth in an instrument in writing signed by the Party to be bound thereby. Any waiver of any term or condition shall not be construed as a waiver of any subsequent breach or a subsequent waiver of the same term or condition, or a waiver of any other term or condition of this Agreement. The failure of either Party to assert any of its rights hereunder shall not constitute a waiver of any of such rights.

SECTION 8.10. Force Majeure .

In no event shall either Party be liable for non-performance or any delay in performance or any interruption of this Agreement caused by circumstances beyond the reasonable control of either Party (each an event of “ Force Majeure ”), including but not limited to (a) acts of God, the elements, epidemics, explosions, accidents, landslides, lightning, earthquakes, fires, storms (including but not limited to tornadoes and hurricanes), sinkholes, floods, or washouts; (b) labor shortage or trouble including strikes or injunctions (whether or not

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

46


within the reasonable control of such party); (c) inability to obtain material, equipment or transportation; (d) national defense requirements, war, acts of terrorism, blockades, insurrections, sabotage, riots, arrests and restraints of the government, either federal or state, civil or military (including any governmental taking by eminent domain or otherwise); or (e) any applicable Law or the enforcement thereof by any Governmental Authority having jurisdiction, that limits or prevents a Party from performing its obligations hereunder or any notice from any such Governmental Authority of its intention to fine or penalize such Party or otherwise impede or limit such Party’s ability to perform its obligations hereunder.

SECTION 8.11. No Third Party Beneficiaries .

This Agreement shall be binding upon and inure solely to the benefit of the Parties and their respective successors and permitted assigns and nothing herein, express or implied, is intended to or shall confer upon any other Person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.

SECTION 8.12. Governing Law; Jurisdiction .

This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York, without application of any conflicts of law principles.

SECTION 8.13. Dispute Resolution .

(a) The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiations, as follows. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Executives of each of the Parties shall meet at a mutually acceptable time and place within ten (10) days after delivery of such written notice, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the dispute. If the matter has not been resolved by these persons within fifteen (15) days of delivery of the disputing Party’s written notice, or if the Parties fail to meet within ten (10) days of delivery of written notice, any Party may initiate arbitration as provided hereinafter.

(b) Any dispute controversy or claim arising out of or relating to this Agreement, the CVAC Sub-License, the Know-How License and the New License, including the breach, termination or validity thereof, not resolved as hereinabove provided or otherwise by agreement between the Parties within forty-five (45) days of initiation of the dispute resolution procedures set forth in this Section 8.13 , shall be finally resolved by binding arbitration in New York, New York in accordance with the American Arbitration Association Commercial Arbitration Rules then in effect pursuant to the following procedures:

(i) Except as otherwise specifically agreed upon by the Parties, the arbitration shall be heard and determined by three (3) arbitrators. Each Party shall appoint an arbitrator of its choice within thirty (30) days of the submission of a notice of arbitration. The Party-appointed arbitrators shall, within ten (10) business days following the appointment of both Party-appointed arbitrators, in turn appoint a third arbitrator who shall be the presiding arbitrator of the tribunal. If the Party-appointed

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

47


arbitrators cannot reach agreement on a presiding arbitrator of the tribunal and/or one Party refuses to appoint its Party-appointed arbitrator within the thirty (30) day period, the American Arbitration Association shall appoint an independent arbitrator who does not have any financial interest in the dispute, controversy or claim. All decisions and awards by the arbitration tribunal shall be made by majority vote.

(ii) The discovery rights of the Parties in connection with the arbitration shall be limited to the production of documents and, for the avoidance of doubt, no Party to such arbitration shall have any right to depose any other party or the officers, directors, employees, agents or other representatives of any other party to such arbitration (and the Arbitrators shall have no authority to compel any such deposition).

(iii) Except as may otherwise be required by law or subpoena, the Parties (including their counsel and other representatives), the witnesses and the arbitrators shall not disclose the existence, contents or results of any arbitration conducted hereunder without the prior written consent of both Parties. Moreover, any documentary or other evidence produced in any arbitration hereunder shall be treated as confidential, and shall not be disclosed to any third party (other than a witness or expert as permitted herein), except as required by law or except if such evidence was obtained from the public domain or was otherwise obtained independently of the arbitration without breach of an independent duty of confidentiality or was lawfully in a Party’s possession.

(iv) Within 120 days of the appointment of the arbitration panel, the arbitrators shall hold hearings where written, documentary, and oral evidence may be presented. Evidence may not be taken except in the presence of both Parties, and all witnesses may be questioned by both Parties. Unless the Parties otherwise agree, or a witness is dead, ill or unavailable for other good reasons, the arbitrators shall not accept a witness’ written statement unless the other Party has an opportunity to question the witness in the arbitrators’ presence, or by telephonic or video telephonic communications. All proceedings shall be conducted in the English language.

(v) The decision of the majority of the arbitrators shall be reduced to a writing, shall give factual and legal reasons for the decision(s) reached by the Arbitrators and shall be signed and dated by the arbitrators, and a copy of the Award shall be delivered to each of the Parties, within ninety (90) days of the completion of the arbitration hearing. The decision of the arbitrators shall be final and binding without the right of appeal; and shall be the sole and exclusive remedy regarding any claims, counterclaims, issues or accountings presented to the arbitrators. The arbitration award shall be made and promptly paid in currency of the transaction giving rise to the dispute, free of any deduction or offset through a bank in the United States. Any costs or fees incident to enforcing the award, shall to the maximum extent permitted by law, be charged against the Party resisting such enforcement. Consequential, punitive or other similar damages shall not be allowed. Each Party hereto waives to the fullest extent permitted by law any right it may otherwise have under the laws of any jurisdiction to any form of appeal of, or collateral attack against, such award. The prevailing Party shall be entitled to recover its costs of arbitration and reasonable attorneys’ fees, as

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

48


determined by the arbitrators. The prevailing Party shall also be entitled to recover its costs and attorneys’ fees in any proceedings to enforce the award or to confirm judgment. The award shall include interest from the date of any breach or violation of the Agreement and/or Ancillary Agreement, as determined by the arbitral award, and from the date of the award until paid in full, at the then current Prime Rate, not to exceed the maximum permitted by law.

(vi) Judgment upon the award may be entered in any court having jurisdiction over the person or the assets of the Party owing the judgment or application may be made to such court for a judicial acceptance of the award and an order of enforcement, as the case may be.

(vii) Nothing in this Agreement shall prevent either Party from seeking any provisional/preliminary relief (including, but not limited to, injunctions, attachments or other such orders in aid of arbitration) from any court of competent jurisdiction, and any such application to a court for provisional/preliminary relief shall not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate.

SECTION 8.14. Counterparts .

This Agreement may be executed and delivered in one or more counterparts, and by the different parties hereto in separate counterparts, each of which when executed shall be deemed to be an original, but all of which taken together shall constitute one and the same agreement. This Agreement may be executed and delivered by facsimile or .pdf transmission.

SECTION 8.15. Construction; Headings .

The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event any ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by both Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any provision of this Agreement. The headings contained in this Agreement are for convenience purposes only and will not in any way affect the meaning or interpretation hereof.

SECTION 8.16. Specific Performance .

Each of the Parties acknowledges and agrees that the other Parties may be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached or violated. Accordingly, each of the Parties agrees that, without posting bond or other undertaking, the other Parties will be entitled to seek an injunction or injunctions to prevent breaches or violations of the provisions of this Agreement and to enforce specifically this Agreement and the terms and provisions hereof in any Action instituted in any court of the United States or any state thereof having jurisdiction over the Parties and the matter in addition to any other remedy to which it may be entitled, at law or in equity.

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

49


[Remainder of Page Intentionally Left Blank; Signature Page Follows]

 

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

50


IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first written above by their respective officers thereunto duly authorized.

 

Executed by Prima Biomed Limited ACN 009 237 889 in accordance with section 127 of the Corporations Act 2001 (Cth)     

/s/ Marc Voigt

    

/s/ Marc Voigt

Signature of director     

Signature of director/company secretary

(Please delete as applicable)

Marc Voigt

    

Marc Voigt

Name of director (print)      Name of director/company secretary (print)

 

Sydys Corporation
By:  

    /s/ Joseph Hernandez

  Name: Joseph Hernandez
  Title: President and CEO
Solely as to Section 2.06(b)(v) :

      /s/ Joseph Hernandez

          Joseph Hernandez

[Signature Page to Asset Purchase Agreement]


Schedules

 

Schedule 1.01(b)    List of Persons for Knowledge of Purchaser
Schedule 1.01(c)    List of Persons for Knowledge of Seller
Schedule 2.03(a)(i)    Inventory, machinery, etc.
Schedule 2.03(a)(iii)    Transferred Books, etc.
Schedule 2.07 (d)    DBI-Sub-Licensees
Schedule 4.06(a)    Capitalization of Purchaser


EXHIBIT A

Transfer Agreement

Prima BioMed Ltd

ACN 009 237 889

and

Sydys Corporation


Transfer Agreement

 

Date    11/12 May 2016

Parties

 

1. Prima BioMed Ltd ACN 009 237 889 of Level 12, 95 Pitt Street, Sydney, New South Wales 2000 ( Prima )

 

2. Sydys Corporation , 135 East 57th Street, 24th Floor, New York, NY 10022 ( Sydys )

Background

 

A. Sydys has concluded a Sub-License, License and Asset Purchase Agreement with Prima executed 12 May 2016 (“ Sub-License, License and Asset Purchase Agreement ”) to which this Agreement is Exhibit A.

 

B. Prima has agreed under the Sub-License, License and Asset Purchase Agreement to (regarding the Transferred Contracts use its best efforts to) sell, assign, transfer and convey to Sydys, and Sydys shall purchase, assume and accept from Prima, on an “as is, where is” basis, free and clear of all Encumbrances other than Permitted Encumbrances, the Purchased Assets.

Agreed terms –

INTENDING TO BE LEGALLY BOUND and for and in consideration of the Consideration set forth in the Sub-License, License and Asset Purchase Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged:

 

1. Definitions

Definitions which are not defined in this Agreement shall have the meaning as defined in the Sub-License, License and Asset Purchase Agreement.

 

2. Transfer of Purchased Assets

Prima does hereby sell, assign, transfer and convey to Sydys, and Sydys does hereby purchase, assume and accept from Prima, all of Seller’s right, title and interest in and to all of the Purchased Assets (for the avoidance of doubt: in particular, but without limitation, the Excluded Assets are explicitly excepted), wherever located, whether or not carried on the books of Seller, as the same may exist on the Closing Date TO HAVE AND TO HOLD the Purchased Assets unto Sydys, its successors and assigns for its use forever on an “as is, where is” basis, free and clear of all Encumbrances other than Permitted Encumbrances except for the Transfer Agreements which are assigned to Sydys (if possible) by separate contracts.

 

3. Miscellaneous

 

3.1 This Transfer Agreement is executed pursuant to the Sub-License, License and Asset Purchase Agreement and is subject to the obligations under, and entitled to the benefits of, the representations, warranties, covenants, agreements and indemnifications set forth therein.


3.2 This Transfer Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Signatures Follow on Next Page]

 

2


The parties hereto have caused this Transfer Agreement to be duly executed and delivered by their duly authorized officers as of the day and year first written above.

 

Executed by Prima BioMed Limited ACN 009 237 889 in accordance with section 127(1) of the Corporations Act 2001 (Cth):     

 

    

 

Signature of director      Signature of director or company secretary*
     *delete whichever does not apply

 

    

 

Name (please print)      Name (please print)
Executed by Sydys Corporation , in accordance with section 127(1) of the Corporations Act 2001 (Cth) :     

 

    

 

Signature of director      Signature of director or company secretary*
     *delete whichever does not apply

 

    

 

Name (please print)      Name (please print)

 

3


EXHIBIT B

CVAC Sub-License

Prima BioMed Ltd

ACN 009 237 889

and

Sydys Corporation


Table of Contents

 

1.

  Definitions and interpretation      1   
1.1   Definitions      1   
1.2   Interpretation      4   

2.

  Sub-Licence      5   
2.1   Sub-Licence in Background Technology and Enabling Technology      5   
2.2   Acknowledgment      5   
2.3   Granting of Sub-Sub-licences      5   

3.

  Intellectual Property      6   
3.1   Intellectual Property obligations      6   
3.2   Improvements      6   

4.

  Notification      6   

5.

  Payment      7   

6.

  Further obligations of Sydys      7   

7.

  GST      7   
7.1   Definitions      7   
7.2   Consideration is GST exclusive      7   
7.3   Payment of GST      8   
7.4   Reimbursement of expenses      8   

8.

  Confidentiality      8   
8.1   Obligations of confidentiality      8   
8.2   Exceptions      8   
8.3   Return of information      9   

9.

  No warranties      9   

10.

  Liability, indemnities and insurance      10   
10.1   Limitation on liability      10   
10.2   Sydys’s indemnity      10   
10.3   Insurance      11   

11.

  Bookkeeping, audit and reviews      11   
11.1   Bookkeeping      11   
11.2   Audit      11   

12.

  Termination      11   
12.1   Termination for cause      11   
12.2   Automatic termination      12   
12.3   Consequences of termination      12   
12.4   Survival      13   


Table of Contents (ctd)

 

13.

   Publicity      13   

14.

   Dispute Resolution      13   

15.

   General      15   

15.1

   Nature of obligations      15   

15.2

   Entire understanding      15   

15.3

   No adverse construction      15   

15.4

   Further assurances      15   

15.5

   No waiver      15   

15.6

   Severability      16   

15.7

   Successors and assigns      16   

15.8

   No assignment      16   

15.9

   Consents and approvals      16   

15.10

   No variation      16   

15.11

   Costs      16   

15.12

   Governing law and jurisdiction      16   

15.13

   Notices      16   

15.14

   Counterparts      17   

15.15

   Conflicting provisions      17   

15.16

   Non merger      17   

15.17

   Operation of indemnities      18   

15.18

   No right of set-off      18   

15.19

   Relationship of parties      18   

 

2


Technology Sub-Licence Agreement

 

Date    11/12 May 2016

Parties

 

1. Prima BioMed Ltd ACN 009 237 889 of Level 12, 95 Pitt Street, Sydney, New South Wales 2000 ( Prima )

 

2. Sydys Corporation , 135 East 57th Street, 24th Floor, New York, NY 10022 ( Sydys )

Background

 

A. Sydys has concluded a Sub-License, License and Asset Purchase Agreement with Prima executed 12 May 2016 (“ Sub-License, License and Asset Purchase Agreement ”) to which this Agreement is Exhibit B.

 

B. Prima has agreed under the Sub-License, License and Asset Purchase Agreement to grant Sydys an exclusive worldwide sub-licence of the CVAC Intellectual Property to the extent permitted by Law on the terms of this Agreement.

Agreed terms

 

1. Definitions and interpretation

 

1.1 Definitions

In this Agreement:

Agreement means this agreement including the background, any schedules and any annexures;

Agreed Field means the treatment of cancer;

Approved Sub-Licensees means Neopharm and any other Sub-Licensee approved by Prima;

Background Technology has the meaning given to that term in the Burnet License;

Burnet means the Macfarlane Burnet Institute for Medical Research and Public Health Ltd (ACN 007 349 984);

Burnet License means the Technology License Agreement dated 31 May 2001, as amended by Deed of Variation dated 24 August 2005, to which Burnet acceded by Deed of Accession dated 22 December 2005 and as novated by Deed of Novation dated 18 April 2012;

Business Day means a day that is not a Saturday, Sunday, public holiday or bank holiday in Sydney, New South Wales;

Commencement Date means 12 May 2016;

Commercialise means:


  (a) to develop, manufacture, use and market the CVAC Intellectual Property;

 

  (b) to use, manufacture, market, sell or otherwise dispose of any product or process resulting from the Commercialisation of the CVAC Intellectual Property; or

 

  (c) to license any third party to do any of the things referred to in paragraph (a) or paragraph (b).

Confidential Information means any and all information of any nature and in any form (including electronic, magnetic and other intangible forms, whether capable of being read by human beings or not) concerning the operations, dealings, organisation, personnel, business strategies, customers, technology, intellectual property rights, trade secrets or know-how of a person which is received by, disclosed to or discovered by the other party ( Receiving Party ) before, on or after the Commencement Date under, in connection with or as a result of this Agreement, any of the matters dealt with in this Agreement in particular but without limitation regarding the CVAC Intellectual Property) or any action taken under this Agreement, but does not include information which:

 

  (a) is or becomes part of the public domain through no act, failure to act or default of the Receiving Party or any person associated with, or who received that information from or as a consequence of disclosure by, the Receiving Party;

 

  (b) is disclosed to the Receiving Party by a third party lawfully in possession of such information and who is not under any obligation to maintain such information in confidence; or

 

  (c) is developed independently by the Receiving Party without use of or reference to the other party’s information.

Corporations Act means the Corporations Act 2001 (Cth) ;

CVAC Intellectual Property means the Background Technology and the Enabling Technology.

Dispute means any dispute or difference of opinion between the parties, or the absence of agreement by the parties, about a matter under or arising out of this Agreement;

Dispute Notice means a notice from Sydys or Prima to the other relating to a Dispute:

 

  (a) requiring the Dispute to be resolved under clause 14; and

 

  (b) outlining the issues which are the subject of the Dispute;

Enabling Technology has the meaning given to that term in the Burnet License.

Field means the treatment of cancer.

Improvements means any amendments, changes or additions made by Sydys to any part of the CVAC Intellectual Property or Research Results;

Insolvency Event means a party becoming subject to bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity;

Intellectual Property Rights means any or all of the following and all rights therein, arising therefrom, or associated therewith: (i) all patents and applications therefor

 

2


anywhere in the world (whether national, international or otherwise) and including all reissues, reexaminations, divisions, renewals, extensions or supplementary protection certificates, provisionals, continuations and continuations-in-part thereof and the like; (ii) all trade secrets, confidential and proprietary information, including unpatented inventions, invention disclosures, moral or economic rights of authors and inventors (however denominated), technical data, know-how, mask works, specifications, methods (whether or not patentable), designs, processes, procedures, and technology; (iii) all copyrights, copyright registrations and applications therefor, and all other rights corresponding thereto throughout the world; and (iv) all industrial designs and any registrations and applications therefor throughout the world.

Know-How License means the non-exclusive license agreement between Prima and Sydys entered into the Sub-License, License and Asset Purchase Agreement in the form set out in Exhibit C to the Sub-License, License and Asset Purchase Agreement.

Neopharm means Neopharm Ltd., a corporation incorporated under the laws of Israel, with registered offices at 6 Hashiloach st Kiryat Matalon, Petach Tikva, Israel.

Neopharm Sub License means the Supply, Distribution and Licensing Agreement between Neopharm and Prima dated 19 February 2014 granting Neopharm an exclusive sub license of the CVAC Intellectual Property exclusively for the State of Israel and The Palestinian Authority which has been assigned to Sydys under Exhibit A of the Sub-License, License and Asset Purchase Agreement.

New License means the non-exclusive license agreement between Prima and Sydys entered into the Sub-License, License and Asset Purchase Agreement in the form set out in Exhibit D to the Sub-License, License and Asset Purchase Agreement.

Patents means the patents specified in Annexure A and any divisional, revalidation, reissuance, re-examination, continuation, continuation-in-part or the like thereof and any foreign patent application or equivalent (including any patents or equivalent issuing thereon) and/or renewals thereof and any extensions thereof (including supplementary protection rights).

Personnel means any employees, agents and approved contractors of a party;

Related Body Corporate has the meaning given to that term in the Corporations Act;

Research and Development means research into the Background Technology and development of opportunities arising out of that research.

Research Results has the meaning given to that term in the Burnet License.

Resolution Period means a 20 Business Day period after a Dispute Notice relating to a Dispute is given;

Sub-Licensee means a third party to which Sydys grants a sub-licence to the Licenced IP which is not an Approved Sub-Licensee;

Sub-Licence has the meaning given to that term in clause 2.1;

Term means, in respect of each Patent in each country in the Territory, the period commencing on the Commencement Date and ending on the earlier to occur of:

 

  (a) the date such Patent expires, lapses or ceases to have effect in a particular country; and

 

3


  (b) any earlier termination of this Agreement; and

Territory means the world.

 

1.2 Interpretation

In this Agreement unless the context requires otherwise:

 

  (a) the singular includes the plural and vice versa;

 

  (b) a gender includes the other genders;

 

  (c) the headings are used for convenience only and do not affect the interpretation of this Agreement;

 

  (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 Agreement 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 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;

 

  (l) 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)”;

 

  (m) money amounts are stated in Australian currency unless otherwise specified;

 

  (n) a reference to time is to Sydney, New South Wales, Australia time;

 

  (o) 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; and

 

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  (p) any agreement, 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.

 

2. Sub-Licence

 

2.1 Sub-Licence in Background Technology and Enabling Technology

 

  (a) Prima hereby grants to Sydys an exclusive, non-transferable sub-licence to the Background Technology within the Agreed Field in the Territory for the Term to:

 

  (i) conduct Research and Development;

 

  (ii) Commercialise the Background Technology (and any Intellectual Property subsisting therein); and

 

  (iii) to the extent necessary, Commercialise the Research Results (and any Intellectual Property subsisting therein),

subject to the terms and conditions of this Agreement ( “Sub-Licence” ).

 

  (b) To the extent necessary to facilitate the Sub-Licence granted under paragraph (ii) or paragraph (iii), Prima grants to Sydys a non-exclusive licence of the Enabling Technology in the Territory for the Term.

 

2.2 Acknowledgment

 

  (a) Sydys acknowledges and agrees that the CVAC Intellectual Property is, and will remain, the exclusive property of Burnet and that nothing in this Agreement will be construed as transferring title in or ownership of any CVAC Intellectual Property to Sydys.

 

  (b) Sydys acknowledges and agrees to Burnet’s rights and Prima’s obligations under the Burnet License, in particular but without limitation

 

  (i) to Burnet’s reservation of rights under Sec. 3.3 and 4.4 of the Burnet License to use the Background Technology for the purposes of the internal research and teaching within Burnet but not for commercial purposes;

 

  (ii) that Burnet will be the owner of Intellectual Property Rights (as defined in the Burnet License) in ARI BTI (as defined in the Burnet License); and

 

  (iii) to Burnet’s rights and Prima’s obligations under Secs. 3.4 (a)-(c), 4.6 (a)-(c) of the Burnet License.

 

2.3 Granting of Sub-Sub-licences

Sydys may not grant any further sub-sub-licences other than to Approved Sub-Licensees.

 

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3. Intellectual Property

 

3.1 Intellectual Property obligations

 

  (a) Sydys accepts all responsibility for maintaining the Patents and paying all of the renewal fees associated with doing so from the Commencement Date;

 

  (b) if Sydys decides to cease payment of renewals for any of the Patents, it must notify Prima in writing at least 30 days prior to the date in which any action needs to be taken to preserve that Patent, in which Prima shall have first rights to resume responsibility of the Patent and the Patent will be removed from the scope of the Sub-Licence;

 

  (c) Sydys must exercise its rights under the Sub-Licence with due care, without danger to any person and in accordance with all applicable laws, and ensure that all Sub-Licensees do so;

 

  (d) Sydys will provide to Prima written annual reports on the progress of the technology commercialisation of the CVAC Intellectual Property on each anniversary of the Commencement Date;

 

  (e) Sydys must co-operate with Prima to satisfy Burnet that the commercialisation undertaken by Sydys pursuant to this Agreement satisfies Prima’s obligation under the Burnet License to use reasonable endeavours to Commercialise the CVAC Intellectual Property, including to participate in any commercialisation review undertaken under the Burnet License from time to time.

 

3.2 Improvements

All right and title in any and all Improvements belong to Sydys and shall be subject to the New License.

 

4. Notification

 

  (a) Sydys will immediately notify Prima, with full particulars available, if Sydys learns:

 

  (i) of any infringement or potential infringement of any of the CVAC Intellectual Property by a third party;

 

  (ii) that the use of any of the CVAC Intellectual Property may infringe the proprietary rights of a third party;

 

  (iii) of any other claims or potential claims against Prima, Sydys, or Neopharm in any way relating to any of the CVAC Intellectual Property (including relating to its use, development or commercialisation), including without limitation:

 

  (A) any claim by a third party for personal injury, death or property damage;

 

  (B) any defects in any products and/or services provided by Sydys and/or any Approved Sub-Licensee which use or incorporate any CVAC Intellectual Property; or

 

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  (C) the need for any recall of any products developed or sold by Sydys or any Approved Sub-Licensee which use or incorporate any of the CVAC Intellectual Property;

 

  (iv) of any wilful, unlawful or negligent act or omission of Sydys, any of its Personnel, or any Approved Sub-Licensee; or

 

  (v) of any infringement by Sydys or an Approved Sub-Licensee of any third party’s Intellectual Property Rights.

 

  (b) In connection with any infringement or potential infringement of or by the CVAC Intellectual Property, Sydys will:

 

  (i) provide all information and assistance to Prima; and

 

  (ii) not take steps on its own without Prima’s prior approval.

 

5. Payment

In consideration of the sub-licence granted to Sydys under this Agreement, Sydys agrees to pay Prima royalties pursuant to Section 2.07 of the Sub-License, License and Asset Purchase Agreement.

For the avoidance of doubt: The obligation to pay the royalties pursuant to Section 2.07 of the Sub-License, License and Asset Purchase Agreement is independent from any expiration or validity of the Burnet License; e.g. Sydys has to pay royalties even after expiration of the patents licensed under this Agreement to Sydys if the requirements of the royalty payments are fulfilled.

 

6. Further obligations of Sydys

Sydys is responsible (i) to fulfil Prima’s obligations towards Burnet under Secs. 4.7, 9 and 12 of the Burnet License in the same scope towards Prima and (ii) to assist Prima in fulfilling its own obligation towards Burnet.

 

7. GST

 

7.1 Definitions

In this Agreement:

 

  (a) the expressions Consideration , GST , Input Tax Credit , Recipient , Supply , Tax Invoice and Taxable Supply have the meanings given to those expressions in the A New Tax System (Goods and Services Tax) Act 1999 ( GST Act ); and

 

  (b) Supplier means any party treated by the GST Act as making a Supply under this Agreement.

 

7.2 Consideration is GST exclusive

Unless otherwise expressly stated, all prices or other sums payable or Consideration to be provided under or in accordance with this Agreement are exclusive of GST.

 

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7.3 Payment of GST

 

  (a) If GST is imposed on any Supply made under or in accordance with this Agreement, the Recipient of the Taxable Supply must pay to the Supplier an additional amount equal to the GST payable on or for the Taxable Supply, subject to the Recipient receiving a valid Tax Invoice in respect of the Supply at or before the time of payment.

 

  (b) Payment of the additional amount must be made at the same time and in the same way as payment for the Taxable Supply is required to be made in accordance with this Agreement.

 

7.4 Reimbursement of expenses

If this Agreement requires a party (the First Party ) to pay for, reimburse, set off or contribute to any expense, loss or outgoing ( Reimbursable Expense ) suffered or incurred by the other party (the Other Party ), the amount required to be paid, reimbursed, set off or contributed by the First Party will be the sum of:

 

  (a) the amount of the Reimbursable Expense net of Input Tax Credits (if any) to which the Other Party is entitled in respect of the Reimbursable Expense ( Net Amount ); and

 

  (b) if the Other Party’s recovery from the First Party is a Taxable Supply, any GST payable in respect of that Supply,

such that after the Other Party meets the GST liability, it retains the Net Amount. Sydys shall pay all patent costs in respect to the CVAC Intellectual Property.

 

8. Confidentiality

 

8.1 Obligations of confidentiality

Each party ( Receiving Party ) receiving, possessing or otherwise acquiring Confidential Information of any other party ( Disclosing Party ) acknowledges that the Disclosing Party’s Confidential Information is the property of and confidential to or a trade secret of the Disclosing Party. Subject to clause 8.2, the Receiving Party must:

 

  (a) keep the Disclosing Party’s Confidential Information confidential and not directly or indirectly disclose, divulge or communicate that Confidential Information to, or otherwise place that Confidential Information at the disposal of, any other person without the prior written approval of the Disclosing Party;

 

  (b) take all reasonable steps to secure and keep secure all Disclosing Party’s Confidential Information coming into its possession or control; and

 

  (c) not memorise, use, modify, reverse engineer or make copies, notes or records of the Disclosing Party’s Confidential Information for any purpose other than in connection with the performance by the Receiving Party of its obligations under this Agreement.

 

8.2 Exceptions

 

  (a) The obligations of confidentiality under clause 8.1 do not apply to any information that is required to be disclosed by any applicable law or any order of any court, tribunal, authority or regulatory body (but only to the extent that it required to be disclosed).

 

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  (b) Sydys may disclose Confidential Information of Prima to Approved Sub-Licensees:

 

  (i) to the extent that those Approved Sub-Licensees need to know the Confidential Information to utilise, develop and commercialise the CVAC Intellectual Property licensed to them by Sydys in accordance with the terms of their sub-licence from Sydys; and

 

  (ii) if (and only if) those Approved Sub-Licensees are contractually bound by confidentiality obligations at least as stringent as those imposed on Sydys by this clause 8.

 

8.3 Return of information

 

  (a) In relation to material containing Confidential Information, the Receiving Party must on demand, or at the expiry or termination of this Agreement:

 

  (i) promptly return to the Disclosing Party any of such material supplied to or received by the Receiving Party or any of its Personnel; or

 

  (ii) if required, destroy any of such material supplied to or received by the Receiving Party or any of its Personnel and supply certification of such destruction where requested.

 

  (b) Despite anything else in this Agreement, the Receiving Party may retain in its files copies of the Confidential Information to the extent the Confidential Information forms part of any board papers or accompanying memoranda submitted to, or the subject of presentations at, meetings of the board of directors of the Receiving Party or its Related Body Corporate or any minutes of meetings of the board of directors of the Receiving Party or its Related Body Corporate.

 

  (c) Notwithstanding anything to the contrary in this Agreement, it is understood and agreed that the Receiving Party’s computer systems may automatically back-up the Confidential Information disclosed to it under this Agreement. To the extent that any computer back-up procedures create copies of the Confidential Information ( Back-up Copies ), the Receiving Party may retain any Back-up Copies in its archival or back-up computer storage for the period it normally archives backed-up computer records. Any Back-up Copies will be subject to the provisions of this Agreement until the same are destroyed, and must not be accessed by the Receiving Party during any period of archival or back-up storage other than as permitted under this Agreement.

 

9. No warranties

Sydys acknowledges that:

 

  (a) the use of the CVAC Intellectual Property and all other material (including Confidential Information) provided to Sydys is at its own risk; and

 

  (b)

to the maximum extent permitted by law the CVAC Intellectual Property is sub-licensed, and all material (including Confidential Information) is provided, to Sydys “as is”, without warranties of any kind (whether express, implied, statutory or

 

9


  otherwise), including with respect to non-infringement of third party rights (including intellectual property rights), merchantability, completeness, reliability, quality or fitness for any particular purpose other than the warranties provided in Article III of the Sub-License, License and Asset Purchase Agreement.

 

10. Liability, indemnities and insurance

 

10.1 Limitation on liability

To the maximum extent permitted by law but not in contradiction to Section 7.02 and 7.04 of the Sub-License, License and Asset Purchase Agreement, Prima will not be liable to Sydys, any Approved Sub-Licensee/Sub-Licensee or any third party in respect of any loss or damage (including, without limitation, any indirect or consequential loss, loss of profit or loss of revenue) however so caused, whether based on contract, tort (including negligence), statute or any other legal theory, arising directly or indirectly in connection with this Agreement, including in respect of the use, commercialisation or the development of the CVAC Intellectual Property by Sydys or any Approved Sub-Licensee/Sub-Licensee or the act, failure or omission of Prima.

 

10.2 Sydys’s indemnity

Sydys will indemnify and hold harmless Prima and its Personnel (each an “ Indemnified Party ”) from and against any and all losses, damages, costs and expenses (including all reasonable legal fees) (each a “ Loss ”) incurred by an Indemnified Party arising directly or indirectly from:

 

  (a) a loss or claim suffered or incurred by Burnet which is to be indemnified by Prima under Sec. 10.2 of the Burnet License as a result of or arising out of or in respect of Sydys’ Research and Development and/or Commercialisation of the CVAC Intellectual Property;

 

  (b) Sydys’s breach of any term of this Agreement (including any representation or warranty provided under this Agreement);

 

  (c) the breach by any Approved Sub-Licensee/Sub-Licensee of any term of its sub-licence agreement with Sydys (including any representation or warranty provided by the Approved Sub-Licensee/Sub-Licensee under that agreement);

 

  (d) any claim by any Approved Sub-Licensee/Sub-Licensee relating to the CVAC Intellectual Property, including in relation to its merchantability, fitness for any particular purpose, or its validity;

 

  (e) any wilful, unlawful or negligent act or omission of Sydys, any of its Personnel, or any Approved Sub-Licensee/Sub-Licensee’s; or

 

  (f) Sydys’s and/or any Approved Sub-Licensee/Sub-Licensee’s use, commercialisation or development of the CVAC Intellectual Property, including without limitation, any:

 

  (i) defects in any products and/or services provided by Sydys and/or any Approved Sub-Licensee/Sub-Licensee which use or incorporate any CVAC Intellectual Property;

 

  (ii) infringement by Sydys or an Approved Sub-Licensee/Sub-Licensee of any third party’s Intellectual Property Rights;

 

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  (iii) claim by a third party for personal injury, death or property damage; or

 

  (iv) recall of any products developed or sold by Sydys or any Approved Sub-Licensee/Sub-Licensee which use or incorporate any of the CVAC Intellectual Property.

 

10.3 Insurance

Sydys must maintain adequate product liability, third party liability and other reasonable insurance (in the joint names of Burnet, Prima and Sydys if required). Sydys must provide adequate evidence of power.

 

11. Bookkeeping, audit and reviews

 

11.1 Bookkeeping

Sydys must keep books and records sufficient to verify the information provided in statements provided to Prima pursuant to Section 2.07 (g) (iv) of the Sub-License, License and Asset Purchase Agreement.

 

11.2 Audit

 

  (a) Sydys must permit Prima and persons or corporations authorised by Prima (including, if Prima so elects, Prima’s external registered auditors) to have access to the books and records of Sydys insofar as they relate to this Agreement, on Business Days between 9am until 5pm upon reasonable notice being given to Sydys ( Audit ). Any information obtained in exercise of the rights of this clause must be kept confidential by Prima and its external auditor and not used or disclosed for any other purpose except for the purposes allowed by this Agreement.

 

  (b) Sydys must cooperate with Prima during any Audit pursuant to clause 11.2(a), including answering any questions raised by Prima, and persons or corporations authorised by Prima to assist in the Audit, promptly and completely.

 

  (c) Prima will pay the cost of any Audit except that:

 

  (i) Prima will not reimburse Sydys for time spent by Sydys Personnel as a result of an Audit request;

 

  (ii) Sydys will not pay for the cost of retrieving records off-site for the purpose of an Audit; and

 

  (d) should an Audit reveal non-compliance by Sydys with any requirements under this Agreement (including any error in statements provided to Prima pursuant to Section 2.07 (g) (iv) of the Sub-License, License and Asset Purchase Agreement leading to underpayment by Sydys), all costs associated with the Audit will be borne by Sydys except for time spent by Prima Personnel.

 

12. Termination

 

12.1 Termination for cause

 

  (a) Either party may terminate this Agreement (in whole or part) with immediate effect at any time by giving written notice to the other party:

 

11


  (i) where the other party (the defaulting party ) commits a breach of a material clause of this Agreement, and that breach is not remedied within 90 (ninety) days of the defaulting party receiving a notice which requests that the breach be remedied; or

 

  (ii) if the other party (the “ Bankrupt Party ”) will file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets, or if the Bankrupt Party proposes a written agreement of composition or extension of its debts, or if the Bankrupt Party will be served with an involuntary petition in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or there will have been issued a warrant of attachment, execution, or similar process against it, filed in any insolvency proceeding, and the petition will not be dismissed within ninety (90) days after the filing thereof, or if the Bankrupt Party will propose or be a party to any dissolution or liquidation, or if the Bankrupt Party will make an assignment for the benefit of creditors.

 

  (b) Prima may terminate this Agreement (in whole or part) with immediate effect at any time by giving notice to Sydys where:

 

  (i) Sydys breaches its obligation pursuant to Section 6.01 of the Sub-License, License and Asset Purchase Agreement (including a deemed breach pursuant to Section 6.02 of the Sub-License, License and Asset Purchase Agreement);

 

  (ii) in Prima’s opinion, the acts or omissions of Sydys, any of its Personnel, or any of its Approved Sub-Licensees, bring or are likely to bring Prima into ridicule or disrepute or are contrary to the interests or stated positions of Prima; or

 

  (iii) Prima is entitled to terminate the Sub-License, License and Asset Purchase Agreement and/or the Know-How License each in accordance with its terms.

 

12.2 Automatic termination

This Agreement terminates automatically if the Burnet License is terminated or expires for any reason whatsoever; whichever is the earlier.

 

12.3 Consequences of termination

 

  (a) On termination of this Agreement:

 

  (i) the Sub-Licence is immediately terminated;

 

  (ii) in case termination is not caused by expiration of the Burnet License each party must immediately cease using the Confidential Information of the other party and return it to the other party in accordance with clause 8.3; and

 

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  (iii) in case termination is not caused by expiration of the Burnet License Sydys must immediately cease using the CVAC Intellectual Property and return to Prima all copies of the CVAC Intellectual Property in the possession, power or control of Sydys or any Approved Sub-Licensee.

 

  (b) Termination of this Agreement will not prejudice any rights or remedies already accrued to any party under, or in respect of any breach of, this Agreement.

 

12.4 Survival

Termination of this Agreement will not affect the operation of the provisions of this Agreement which by their nature survive termination or expiry of this Agreement.

 

13. Publicity

 

  (a) Sydys agrees not to issue any press release or make any public announcement relating to the subject matter of this Agreement without the prior consent of Prima, except as required by law or a court order.

 

  (b) Subject to any permitted disclosures under clause 13(a), Sydys agrees that it will not create the impression that any acts or omissions of Sydys or any Approved Sub-Licensee/Sub-Licensee in relation to the CVAC Intellectual Property are authorised by Prima.

 

14. Dispute Resolution

 

  (a) The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiations, as follows. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Executives of each of the Parties shall meet at a mutually acceptable time and place within ten (10) days after delivery of such written notice, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the dispute. If the matter has not been resolved by these persons within fifteen (15) days of delivery of the disputing Party’s written notice, or if the Parties fail to meet within ten (10) days of delivery of written notice, any Party may initiate arbitration as provided hereinafter.

 

  (b) Any dispute controversy or claim arising out of or relating to this Agreement, including the breach, termination or validity thereof, not resolved as hereinabove provided or otherwise by agreement between the Parties within forty-five (45) days of initiation of the dispute resolution procedures set forth in this Section 14, shall be finally resolved by binding arbitration in New York, New York in accordance with the American Arbitration Association Commercial Arbitration Rules then in effect pursuant to the following procedures:

 

  (i)

Except as otherwise specifically agreed upon by the Parties, the arbitration shall be heard and determined by three (3) arbitrators. Each Party shall appoint an arbitrator of its choice within thirty (30) days of the submission of a notice of arbitration. The Party-appointed arbitrators shall, within ten (10) business days following the appointment of both Party-appointed arbitrators, in turn appoint a third arbitrator who shall be the presiding arbitrator of the tribunal. If the Party-appointed arbitrators cannot reach agreement on a presiding arbitrator of the tribunal and/or one Party refuses to appoint its Party-appointed arbitrator within the thirty (30) day period, the

 

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  American Arbitration Association shall appoint an independent arbitrator who does not have any financial interest in the dispute, controversy or claim. All decisions and awards by the arbitration tribunal shall be made by majority vote.

 

  (ii) The discovery rights of the Parties in connection with the arbitration shall be limited to the production of documents and, for the avoidance of doubt, no Party to such arbitration shall have any right to depose any other party or the officers, directors, employees, agents or other representatives of any other party to such arbitration (and the Arbitrators shall have no authority to compel any such deposition).

 

  (iii) Except as may otherwise be required by law or subpoena, the Parties (including their counsel and other representatives), the witnesses and the arbitrators shall not disclose the existence, contents or results of any arbitration conducted hereunder without the prior written consent of both Parties. Moreover, any documentary or other evidence produced in any arbitration hereunder shall be treated as confidential, and shall not be disclosed to any third party (other than a witness or expert as permitted herein), except as required by law or except if such evidence was obtained from the public domain or was otherwise obtained independently of the arbitration without breach of an independent duty of confidentiality or was lawfully in a Party’s possession.

 

  (iv) Within 120 days of the appointment of the arbitration panel, the arbitrators shall hold hearings where written, documentary, and oral evidence may be presented. Evidence may not be taken except in the presence of both Parties, and all witnesses may be questioned by both Parties. Unless the Parties otherwise agree, or a witness is dead, ill or unavailable for other good reasons, the arbitrators shall not accept a witness’ written statement unless the other Party has an opportunity to question the witness in the arbitrators’ presence, or by telephonic or video telephonic communications. All proceedings shall be conducted in the English language.

 

  (v)

The decision of the majority of the arbitrators shall be reduced to a writing, shall give factual and legal reasons for the decision(s) reached by the Arbitrators and shall be signed and dated by the arbitrators, and a copy of the Award shall be delivered to each of the Parties, within ninety (90) days of the completion of the arbitration hearing. The decision of the arbitrators shall be final and binding without the right of appeal; and shall be the sole and exclusive remedy regarding any claims, counterclaims, issues or accountings presented to the arbitrators. The arbitration award shall be made and promptly paid in currency of the transaction giving rise to the dispute, free of any deduction or offset through a bank in the United States. Any costs or fees incident to enforcing the award, shall to the maximum extent permitted by law, be charged against the Party resisting such enforcement. Consequential, punitive or other similar damages shall not be allowed. Each Party hereto waives to the fullest extent permitted by law any right it may otherwise have under the laws of any jurisdiction to any form of appeal of, or collateral attack against, such award. The prevailing Party shall be entitled to recover its costs of arbitration and reasonable attorneys’ fees, as determined by the arbitrators. The prevailing Party shall also be entitled to recover its costs and attorneys’ fees in any proceedings to enforce the award or to confirm judgment. The award shall include interest from the date of any breach or violation of the Agreement

 

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  and/or Ancillary Agreement, as determined by the arbitral award, and from the date of the award until paid in full, at the then current Prime Rate, not to exceed the maximum permitted by law.

 

  (vi) Judgment upon the award may be entered in any court having jurisdiction over the person or the assets of the Party owing the judgment or application may be made to such court for a judicial acceptance of the award and an order of enforcement, as the case may be.

 

  (vii) Nothing in this Agreement shall prevent either Party from seeking any provisional/preliminary relief (including, but not limited to, injunctions, attachments or other such orders in aid of arbitration) from any court of competent jurisdiction, and any such application to a court for provisional/preliminary relief shall not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate.

 

15. General

 

15.1 Nature of obligations

Each obligation imposed on a party by this Agreement in favour of another is a separate obligation.

 

15.2 Entire understanding

 

  (a) This Agreement contains the entire understanding between the parties concerning the subject matter of the Agreement and supersedes all prior communications between the parties.

 

  (b) Each party acknowledges that, except as expressly stated in this Agreement, that party has not relied on any representation, warranty or undertaking of any kind made by or on behalf of the other party in relation to the subject matter of this Agreement.

 

15.3 No adverse construction

This Agreement is not to be construed to the disadvantage of a party because that party was responsible for its preparation.

 

15.4 Further assurances

A party, at its own expense and within a reasonable time of being requested by another party to do so, must do all things and execute all documents that are reasonably necessary to give full effect to this Agreement.

 

15.5 No waiver

 

  (a) A failure, delay, relaxation or indulgence by a party in exercising any power or right conferred on the party by this Agreement does not operate as a waiver of the power or right.

 

  (b) A single or partial exercise of the power or right does not preclude a further exercise of it or the exercise of any other power or right under this Agreement.

 

  (c) A waiver of a breach does not operate as a waiver of any other breach.

 

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15.6 Severability

Any provision of this Agreement 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 Agreement in any other case,

without invalidating or affecting the remaining provisions of this Agreement or the validity of that provision in any other jurisdiction.

 

15.7 Successors and assigns

This Agreement binds and benefits the parties and their respective successors and permitted assigns under clause 15.8.

 

15.8 No assignment

 

  (a) Sydys cannot assign or otherwise transfer the benefit of this Agreement without the prior written consent of Prima.

 

  (b) Prima may not assign or otherwise transfer the benefit of this Agreement without the need for Sydys’s prior consent.]

 

15.9 Consents and approvals

Where anything depends on the consent or approval of a party then, unless this Agreement provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

15.10 No variation

This Agreement cannot be amended or varied except in writing signed by the parties.

 

15.11 Costs

Each party must pay its own legal costs of and incidental to the preparation and completion of this Agreement.

 

15.12 Governing law and jurisdiction

 

  (a) This Agreement is governed by and must be construed in accordance with the laws in force in New South Wales.

 

  (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 Agreement, its performance or subject matter.

 

15.13 Notices

Any notice or other communication to or by a party under this Agreement:

 

  (a) may be given by personal service, post or facsimile;

 

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  (b) must be in writing, legible and in English addressed (depending on the manner in which it is given) as shown below:

 

  (i) If to Sydys :

 

  Address:    135 East 57th Street, 24th Floor, New York, NY 10022
  Attention:    Joseph Hernandez
  Email:    hernandez_joe@yahoo.com

 

  (ii) If to Prima:

 

  Address:    Level 12, 95 Pitt Street Sydney 2000, NSW, Australia
  Attention:    Mr Marc Voigt (CEO)
  Email:    marc.voigt@primabiomed.com.au
  Facsimile:    +61 2 8569 1880

or to any other address last notified by the party to the sender by notice given in accordance with this clause;

 

  (c) in the case of a corporation, must be signed by an officer or authorised representative of the sender or in accordance with section 127 of the Corporations Act; and

 

  (d) is deemed to be given by the sender and received by the addressee:

 

  (i) if delivered in person, when delivered to the addressee;

 

  (ii) if posted, 2 Business Days (or 6, if addressed outside Australia) after the date of posting to the addressee whether delivered or not; or

 

  (iii) if sent by facsimile transmission, on the date and time shown on the transmission report by the machine from which the facsimile was sent which indicates that the facsimile was sent in its entirety and in legible form to the facsimile number of the addressee notified for the purposes of this clause,

but if the delivery or receipt is on a day which is not a Business Day or is after 4.00 pm (addressee’s time), it is deemed to have been received at 9.00 am on the next Business Day.

 

15.14 Counterparts

If this Agreement consists of a number of signed counterparts, each is an original and all of the counterparts together constitute the same document.

 

15.15 Conflicting provisions

If there is any conflict between the main body of this Agreement and any schedules or annexures comprising it, then the provisions of the main body of this Agreement prevail.

 

15.16 Non merger

A term or condition of, or act done in connection with, this Agreement does not operate as a merger of any of the rights or remedies of the parties under this Agreement and those rights and remedies continue unchanged.

 

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15.17 Operation of indemnities

Unless this Agreement expressly provides otherwise:

 

  (a) each indemnity in this Agreement survives the expiry or termination of this Agreement; and

 

  (b) a party may recover a payment under an indemnity in this Agreement before it makes the payment in respect of which the indemnity is given.

 

15.18 No right of set-off

Unless this Agreement expressly provides otherwise, a party has no right of set-off against a payment due to another party.

 

15.19 Relationship of parties

Unless this Agreement expressly provides otherwise, nothing in this Agreement may be construed as creating a relationship of partnership, of principal and agent or of trustee and beneficiary.

 

18


Executed as an Agreement.

 

Executed by Prima BioMed Limited ACN 009 237 889 in accordance with section 127(1) of

the Corporations Act 2001 (Cth):

    

 

Signature of director

    

 

Signature of director or company secretary*

     *delete whichever does not apply

 

Name (please print)

    

 

Name (please print)

Executed by Sydys Corporation in accordance with section 127(1) of the

Corporations Act 2001 (Cth):

    

 

Signature of director

    

 

Signature of director or company secretary*

     *delete whichever does not apply

 

Name (please print)

    

 

Name (please print)

 

19


ANNEXURE A

List of Patents

Family 3

 

Patent
Number

  

Country

  

Status Jan 15

  

Expiry

754065    Australia    Granted    29/09/2018
2,304,952    Canada    Granted    29/09/2018
1027063    Europe    Granted.  Validated Austria,
Belgium, Denmark, France,
Germany, Italy, Ireland, Spain,
Sweden, Switzerland,
Netherlands, UK
   29/09/2018
4669930    Japan    Granted    29/09/2018
5192020    Japan    Granted    29/09/2018
8,771,701    USA    Granted    08/08/2022

Please note, all patent expiry dates are approximate. It is possible for patent term extensions to be granted if market authorisation is achieved prior to expiry.

 

20


EXHIBIT C

Know-How License and Sub-license

Prima BioMed Ltd

ACN 009 237 889

and

Sydys Corporation


Table of Contents

 

1.      Definitions and interpretation      1   
1.1      Definitions      1   
1.2      Interpretation      3   
2.      License and Sub-License      4   
2.1      License and Sub-License      4   
2.2      Acknowledgment      4   
2.3      Sub-license      5   
3.      Know-How Obligations      5   
3.1      Sydys obligations      5   
3.2      Prima obligations      5   
3.3      Improvements      5   
4.      Notification      5   
5.      Payment obligations      6   
5.1      Fees payable by Sydys      6   
6.      GST      6   
6.1      Definitions      6   
6.2      Consideration is GST exclusive      7   
6.3      Payment of GST      7   
6.4      Reimbursement of expenses      7   
7.      Confidentiality      7   
7.1      Obligations of confidentiality      7   
7.2      Exceptions      8   
7.3      Return of information      8   
8.      No warranties      9   
9.      Liability, indemnities and insurance      9   
9.1      Limitation on liability      9   
9.2      Sydys’s indemnity      9   
9.3      Insurance      10   
10.      Bookkeeping, audit and reviews      10   
10.1      Bookkeeping      10   
10.2      Audit      10   
11.      Termination      11   
11.1      Termination for cause      11   
11.2      Automatic termination      12   
11.3      Consequences of termination      12   
11.4      Survival      12   


Table of Contents (ctd)

 

12.      Publicity    12
13.      Dispute Resolution    12
14.      General    14
14.1      Nature of obligations    14
14.2      Entire understanding    14
14.3      No adverse construction    15
14.4      Further assurances    15
14.5      No waiver    15
14.6      Severability    15
14.7      Successors and assigns    15
14.8      No assignment    15
14.9      Consents and approvals    15
14.10      No variation    16
14.11      Costs    16
14.12      Governing law and jurisdiction    16
14.13      Notices    16
14.14      Counterparts    17
14.15      Conflicting provisions    17
14.16      Non merger    17
14.17      Operation of indemnities    17
14.18      No right of set-off    17
14.19      Relationship of parties    17

 

2


Know-How License Agreement

Date                                          11/12 May 2016

Parties

 

1. Prima BioMed Ltd ACN 009 237 889 of Level 12, 95 Pitt Street, Sydney, New South Wales 2000 ( Prima )

 

2. Sydys Corporation , 135 East 57th Street, 24th Floor, New York, NY 10022 ( Sydys )

Background

 

A. Sydys has concluded a Sub-License, License and Asset Purchase Agreement with Prima executed 12 May 2016 (“ Sub-License, License and Asset Purchase Agreement ”) to which this Agreement is Exhibit C.

 

B. Prima has agreed under the Sub-License, License and Asset Purchase Agreement to grant Sydys a non-exclusive worldwide license of the Know-How to the extent permitted by Law on the terms of this Agreement.

Agreed terms

 

1. Definitions and interpretation

 

1.1 Definitions

In this Agreement:

Agreed Field means the treatment of cancer;

Agreement means this agreement including the background, any schedules and any annexures;

Approved Sub-Licensees means any Sub-Licensee approved by Prima;

Burnet  means the Macfarlane Burnet Institute for Medical Research and Public Health Ltd (ACN 007 349 984);

Burnet License means the Technology License Agreement dated 31 May 2001, as amended by Deed of Variation dated 24 August 2005, to which Burnet acceded by Deed of Accession dated 22 December 2005 and as novated by Deed of Novation dated 18 April 2012;

Business Day means a day that is not a Saturday, Sunday, public holiday or bank holiday in Sydney, New South Wales;

Commencement Date means 12 May 2016;

Confidential Information means any and all information of any nature and in any form (including electronic, magnetic and other intangible forms, whether capable of being read by human beings or not) concerning the CVAC Know How, the operations, dealings, organisation, personnel, business strategies, customers, technology, intellectual property rights, trade secrets or know-how of a person which is received by, disclosed to or


discovered by the other party ( Receiving Party ) before, on or after the Commencement Date under, in connection with or as a result of this Agreement, any of the matters dealt with in this Agreement or any action taken under this Agreement, but does not include information which:

 

  (a) is or becomes part of the public domain through no act, failure to act or default of the Receiving Party or any person associated with, or who received that information from or as a consequence of disclosure by, the Receiving Party;

 

  (b) is disclosed to the Receiving Party by a third party lawfully in possession of such information and who is not under any obligation to maintain such information in confidence; or

 

  (c) is developed independently by the Receiving Party without use of or reference to the other party’s information.

Corporations Act means the Corporations Act 2001 (Cth) ;

CVAC Know How means (i) the Research Results (as defined in the Burnet License) owned by Prima; (ii) the Assigned IP (as defined in the Deed of Assignment) assigned to Prima from Cancer Vac Pty Ltd (CAN 096859513) by Deed of Assignment; and (iii) the CVAC Trademarks.

CVAC Products means any formulation containing mannosylated fusion protein conjugated to mucin1; that has been pulsed ex vivo into a patients’ dendritic cells and then reinjected back into said patient, developed by or on behalf of Prima prior to the date of the Sub-License, License and Asset Purchase Agreement.

CVAC Sub-License means the exclusive license agreement between Prima and Sydys entered into pursuant to the Sub-License, License and Asset Purchase Agreement in the form set out in Exhibit B to the Sub-License, License and Asset Purchase Agreement.

CVAC Trademarks means the trademarks, trade names and logos licensed by Prima from Prima Biomed IP Pty Ltd. as listed in Annexure A.

Deed of Assignment  means the deed of assignment of intellectual property rights dated 26 June 2012 between Cancer Vac Pty Ltd ACN 096 859 513 and Prima;

Dispute means any dispute or difference of opinion between the parties, or the absence of agreement by the parties, about a matter under or arising out of this Agreement;

Dispute Notice means a notice from Sydys or Prima to the other relating to a Dispute:

 

  (a) requiring the Dispute to be resolved under clause 13; and

 

  (b) outlining the issues which are the subject of the Dispute;

Further Know-How means all trade secrets, confidential and proprietary information generated by Prima and its Affiliates relating to the automation and/or optimization of manufacturing processes for any cell therapy that have been developed by Prima or in conjunction with funding by the Sächsische Aufbaubank (SAB) and under contracts with the Fraunhofer Institute for Cell Therapy and Immunology, Leipzig and Database Integrations Inc (DBI), USA. This includes, but is not limited to, documentation for the technology transfer of its manufacturing and logistics operations to the United States of America and to Europe, data, know-how and standard operating procedures (SOP’s) (whether patentable or not) relating to the automation of cell therapy manufacturing and

 

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the optimisation for dendritic cell and other cell therapies, cold chain supply logistics, iCAN Software development, bar code labelling qualifications, shipping qualification and other related procedures necessary for the manufacturing and shipment of blood products and miscellaneous cell therapy products.

Improvements means any amendments, changes or additions made by Sydys to any part of the Licensed Know-How;

Insolvency Event means a party becoming subject to bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity;

Licensed Know-How means (i) CVAC Know How; and (ii) Further Know-How.

New License means the non-exclusive license agreement between Prima and Sydys entered into pursuant to the Sub-License, License and Asset Purchase Agreement in the form set out in Exhibit D to the Sub-License, License and Asset Purchase Agreement.

Personnel means any employees, agents and approved contractors of a party;

Related Body Corporat e has the meaning given to that term in the Corporations Act;

Resolution Period means a 20 Business Day period after a Dispute Notice relating to a Dispute is given;

Sub-Licensee means a third party to which Sydys grants a sub-license to the Licensed IP which is not an Approved Sub-Licensee;

Sub-License has the meaning given to that term in clause 2.1; and

Territory means the world.

Definitions which are not defined in this Agreement shall have the meaning as defined in the Sub-License, License and Asset Purchase Agreement.

 

1.2 Interpretation

In this Agreement unless the context requires otherwise:

 

  (a) the singular includes the plural and vice versa;

 

  (b) a gender includes the other genders;

 

  (c) the headings are used for convenience only and do not affect the interpretation of this Agreement;

 

  (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 Agreement and a reference to a party to a document includes the party’s executors, administrators, successors and permitted assigns and substitutes;

 

3


  (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 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;

 

  (l) 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)”;

 

  (m) money amounts are stated in Australian currency unless otherwise specified;

 

  (n) a reference to time is to Sydney, New South Wales, Australia time;

 

  (o) 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; and

 

  (p) any agreement, 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.

 

2. License and Sub-License

 

2.1 License and Sub-License

Subject to the terms of this Agreement (to the extent permitted by Law), Prima grants Sydys within the Agreed Field in the Territory a non-exclusive, non-transferable

 

  (a) license to use the Licensed Know-How; and

 

  (b) sub-license to use the CVAC Trademarks

in each case to commercialise and develop the CVAC Products and the New CVAC Products anywhere in the world.

 

2.2 Acknowledgment

 

  (a) Sydys acknowledges and agrees that the CVAC Know How is, and will remain the exclusive property of Prima or its Affiliates and that nothing in this Agreement will be construed as transferring title in or ownership of any CVAC Know How to Sydys.

 

4


  (b) Sydys acknowledges and agrees to any and all obligations of Prima towards Burnet under the Burnet License regarding the CVAC Know-How, in particular but without limitation to the license granted by Prima to Burnet under Sec. 4.4 of the Burnet License.

 

2.3 Sub-license

Sydys may not grant any sub-licenses with regard to the Licensed Know-How and no further sub-licenses with regard to the CVAC Trademarks other than to Approved Sub-Licensees.

 

3. Know-How Obligations

 

3.1 Sydys obligations

 

  (a) Sydys will provide to Prima written annual reports on the progress of the commercialisation of the Licensed Know-How on the Commencement Date.

 

  (b) If Sydys wants to prolong the protection of the CVAC Trademarks, Sydys shall be responsible to pay the renewal fees with respect to the CVAC Trademarks itself.

 

  (c) Sydys shall use its best efforts to support Prima in fulfilling its obligations under the Burnet License and the Deed of Assignment with respect to the CVAC Know How respectively.

 

  (d) Sydys is obliged to grant a respective license to Burnet regarding any Research Results owned by or licensed to Sydys in case Burnet exercises its option to negotiate a non-exclusive license to use the Research Results solely to the extent necessary for Burnet to commercialise the Background Technology outside the Agreed Field pursuant to Sec. 4.6 of the Burnet License.

 

  (e) Sydys shall cover Burnet’s costs under Sec. 4.4 (d) of the Burnet License.

 

3.2 Prima obligations

 

  (a) Prima shall not use the Licensed Know-how (except as required under the funding by the Sächsische Aufbaubank (SAB)) and the CVAC Trademarks to commercialise and develop the CVAC products and the New CVAC Products anywhere in the world as long as Sydys is not in breach pursuant to Section 6.02 of the Sub-License, License and Asset Purchase Agreement.

 

  (b) Prima shall not grant any further licenses to the Licensed Know-How (except as required under the funding by the Sächsische Aufbaubank (SAB)) and any further Sub-Licenses to the CVAC Trademarks as long as Sydys is not in breach pursuant to Section 6.02 of the Sub-License, License and Asset Purchase Agreement.

 

3.3 Improvements

All right and title in any and all Improvements belong to Sydys and shall be subject to the New License.

 

4. Notification

(a) Sydys will immediately notify Prima, with full particulars available, if Sydys learns:

 

5


  (i) of any infringement or potential infringement of any of the Licensed Know-How and CVAC Trademarks by a third party;

 

  (ii) that the use of any of the Licensed Know-How and CVAC Trademarks may infringe the proprietary rights of a third party;

 

  (iii) of any other claims or potential claims against Prima, Sydys, or any Approved Sub-Licensee in any way relating to any of the Licensed Know-How and CVAC Trademarks (including relating to its use, development or commercialisation), including without limitation:

 

  (A) any claim by a third party for personal injury, death or property damage;

 

  (B) any defects in any products and/or services provided by Sydys and/or any Approved Sub-Licensee which use or incorporate any Licensed Know-How and CVAC Trademarks; or

 

  (C) the need for any recall of any products developed or sold by Sydys or any Approved Sub-Licensee which use or incorporate any of the Licensed Know-How and CVAC Trademarks;

 

  (iv) of any wilful, unlawful or negligent act or omission of Sydys, any of its Personnel, or any Approved Sub-Licensee; or

 

  (v) of any infringement by Sydys or an Approved Sub-Licensee of any third party’s Intellectual Property Rights.

 

  (b) In connection with any infringement or potential infringement of or by the Licensed Know-How and CVAC Trademarks, Sydys will:

 

  (i) provide all information and assistance to Prima; and

 

  (ii) not take steps on its own without Prima’s prior approval.

 

5. Payment obligations

 

5.1 Fees payable by Sydys

In consideration of the (sub-)license granted to Sydys under this Agreement, Sydys agrees to pay Prima a consideration pursuant to Sections 2.06, 2.07 of the Sub-License, License and Asset Purchase Agreement (allocated as described in there).

For the avoidance of doubt: The obligation to pay the royalties pursuant to Sections 2.06, 2.07 of the Sub-License, License and Asset Purchase Agreement is independent from any expiration or validity of the Burnet License; e.g. Sydys has to pay royalties even after expiration of the patents licensed under this Agreement to Sydys if the requirements of the royalty payments are fulfilled.

 

6. GST

 

6.1 Definitions

In this Agreement:

 

6


  (a) the expressions Consideration , GST , Input Tax Credit , Recipient , Supply , Tax Invoice and Taxable Supply have the meanings given to those expressions in the A New Tax System ( Goods and Services Tax ) Act 1999 ( GST Act ); and

 

  (b) Supplier means any party treated by the GST Act as making a Supply under this Agreement.

 

6.2 Consideration is GST exclusive

Unless otherwise expressly stated, all prices or other sums payable or Consideration to be provided under or in accordance with this Agreement are exclusive of GST.

 

6.3 Payment of GST

 

  (a) If GST is imposed on any Supply made under or in accordance with this Agreement, the Recipient of the Taxable Supply must pay to the Supplier an additional amount equal to the GST payable on or for the Taxable Supply, subject to the Recipient receiving a valid Tax Invoice in respect of the Supply at or before the time of payment.

 

  (b) Payment of the additional amount must be made at the same time and in the same way as payment for the Taxable Supply is required to be made in accordance with this Agreement.

 

6.4 Reimbursement of expenses

If this Agreement requires a party (the First Party ) to pay for, reimburse, set off or contribute to any expense, loss or outgoing ( Reimbursable Expense ) suffered or incurred by the other party (the Other Party ), the amount required to be paid, reimbursed, set off or contributed by the First Party will be the sum of:

 

  (a) the amount of the Reimbursable Expense net of Input Tax Credits (if any) to which the Other Party is entitled in respect of the Reimbursable Expense ( Net Amount ); and

 

  (b) if the Other Party’s recovery from the First Party is a Taxable Supply, any GST payable in respect of that Supply,

such that after the Other Party meets the GST liability, it retains the Net Amount. The costs (e.g. annual renewal fees) to maintain the patents will be directly or indirectly borne by Sydys.

 

7. Confidentiality

 

7.1 Obligations of confidentiality

Each party ( Receiving Party ) receiving, possessing or otherwise acquiring Confidential Information of any other party ( Disclosing Party ) acknowledges that the Disclosing Party’s Confidential Information is the property of and confidential to or a trade secret of the Disclosing Party. Subject to clause 7.2, the Receiving Party must:

 

  (a) keep the Disclosing Party’s Confidential Information confidential and not directly or indirectly disclose, divulge or communicate that Confidential Information to, or otherwise place that Confidential Information at the disposal of, any other person without the prior written approval of the Disclosing Party;

 

7


  (b) take all reasonable steps to secure and keep secure all Disclosing Party’s Confidential Information coming into its possession or control; and

 

  (c) not memorise, use, modify, reverse engineer or make copies, notes or records of the Disclosing Party’s Confidential Information for any purpose other than in connection with the performance by the Receiving Party of its obligations under this Agreement.

 

7.2 Exceptions

 

  (a) The obligations of confidentiality under clause 7.1 do not apply to any information that is required to be disclosed by any applicable law or any order of any court, tribunal, authority or regulatory body (but only to the extent that it required to be disclosed).

 

  (b) Sydys may disclose Confidential Information of Prima to Approved Sub-Licensees:

 

  (i) to the extent that those Approved Sub-Licensees need to know the Confidential Information to utilise, develop and commercialise the Licensed Know-How and CVAC Trademarks licensed to them by Sydys in accordance with the terms of their sub-license from Sydys; and

 

  (ii) if (and only if) those Approved Sub-Licensees are contractually bound by confidentiality obligations at least as stringent as those imposed on Sydys by this clause 7.

 

7.3 Return of information

 

  (a) In relation to material containing Confidential Information, the Receiving Party must on demand, or at the termination of this Agreement:

 

  (i) promptly return to the Disclosing Party any of such material supplied to or received by the Receiving Party or any of its Personnel; or

 

  (ii) if required, destroy any of such material supplied to or received by the Receiving Party or any of its Personnel and supply certification of such destruction where requested.

 

  (b) Despite anything else in this Agreement, the Receiving Party may retain in its files copies of the Confidential Information to the extent the Confidential Information forms part of any board papers or accompanying memoranda submitted to, or the subject of presentations at, meetings of the board of directors of the Receiving Party or its Related Body Corporate or any minutes of meetings of the board of directors of the Receiving Party or its Related Body Corporate.

 

  (c) Notwithstanding anything to the contrary in this Agreement, it is understood and agreed that the Receiving Party’s computer systems may automatically back-up the Confidential Information disclosed to it under this Agreement. To the extent that any computer back-up procedures create copies of the Confidential Information (Back-up Copies), the Receiving Party may retain any Back-up Copies in its archival or back-up computer storage for the period it normally archives backed-up computer records. Any Back-up Copies will be subject to the provisions of this Agreement until the same are destroyed, and must not be accessed by the Receiving Party during any period of archival or back-up storage other than as permitted under this Agreement.

 

8


8. No warranties

Sydys acknowledges that:

 

  (a) the use of the Licensed Know-How and CVAC Trademarks and all other material (including Confidential Information) provided to Sydys is at its own risk; and

 

  (b) to the maximum extent permitted by law the Licensed Know-How and CVAC Trademarks is (sub-)licensed, and all material (including Confidential Information) is provided, to Sydys “as is”, without warranties of any kind (whether express, implied, statutory or otherwise), including with respect to non-infringement of third party rights (including intellectual property rights), merchantability, completeness, reliability, quality or fitness for any particular purpose other than the warranties provided in Article III of the Sub-License, License and Asset Purchase Agreement.

 

9. Liability, indemnities and insurance

 

9.1 Limitation on liability

To the maximum extent permitted by law but not in contradiction to Section 7.02 and 7.04 of the Sub-License, License and Asset Purchase Agreement, Prima will not be liable to Sydys, any Approved Sub-Licensee/Sub-Licensee or any third party in respect of any loss or damage (including, without limitation, any indirect or consequential loss, loss of profit or loss of revenue) however so caused, whether based on contract, tort (including negligence), statute or any other legal theory, arising directly or indirectly in connection with this Agreement, including in respect of the use, commercialisation or the development of the Licensed Know-How and CVAC Trademarks by Sydys or any Approved Sub-Licensee/Sub-Licensee or the act, failure or omission of Prima.

 

9.2 Sydys’s indemnity

Sydys will indemnify and hold harmless Prima and its Personnel (each an “ Indemnified Party ”) from and against any and all losses, damages, costs and expenses (including all reasonable legal fees) (each a “ Loss ”) incurred by an Indemnified Party arising directly or indirectly from:

 

  (a) a loss or claim suffered or incurred by Burnet which is to be indemnified by Prima under Sec. 10.2 of the Burnet License as a result of or arising out of or in respect of Sydys’ Research and Development and/or Commercialisation of the Research Results;

 

  (b) Sydys’ breach of any term of this Agreement (including any representation or warranty provided under this Agreement);

 

  (c) the breach by any Approved Sub-Licensee/Sub-Licensee of any term of its sub-license agreement with Sydys (including any representation or warranty provided by the Approved Sub-Licensee/Sub-Licensee under that agreement);

 

  (d) any claim by any Approved Sub-Licensee/Sub-Licensee relating to the Licensed Know-How and CVAC Trademarks, including in relation to its merchantability, fitness for any particular purpose, or its validity;

 

9


  (e) any wilful, unlawful or negligent act or omission of Sydys, any of its Personnel, or any Approved Sub-Licensee/Sub-Licensee’s; or

 

  (f) Sydys’ and/or any Approved Sub-Licensee/Sub-Licensee’s use, commercialisation or development of the Licensed Know-How and CVAC Trademarks, including without limitation, any:

 

  (i) defects in any products and/or services provided by Sydys and/or any Approved Sub-Licensee/Sub-Licensee which use or incorporate any Licensed Know-How and CVAC Trademarks;

 

  (ii) infringement by Sydys or an Approved Sub-Licensee/Sub-Licensee of any third party’s Intellectual Property Rights;

 

  (iii) claim by a third party for personal injury, death or property damage; or

 

  (iv) recall of any products developed or sold by Sydys or any Approved Sub-Licensee/Sub-Licensee which use or incorporate any of the Licensed Know-How and CVAC Trademarks.

 

9.3 Insurance

Sydys must maintain adequate product liability, third party liability and other reasonable insurance (in the joint names of Burnet, Prima and Sydys if required). Sydys must provide adequate evidence of power.

 

10. Bookkeeping, audit and reviews

 

10.1 Bookkeeping

Sydys must keep books and records sufficient to verify the information provided in statements provided to Prima pursuant to Section 2.07 (g) (iv) of the Sub-License, License and Asset Purchase Agreement.

 

10.2 Audit

 

  (a) Sydys must permit Prima and persons or corporations authorised by Prima (including, if Prima so elects, Prima’s external registered auditors) to have access to the books and records of Sydys insofar as they relate to this Agreement, on Business Days between 9am until 5pm upon reasonable notice being given to Sydys ( Audit ). Any information obtained in exercise of the rights of this clause must be kept confidential by Prima and its external auditor and not used or disclosed for any other purpose except for the purposes allowed by this Agreement.

 

  (b) Sydys must cooperate with Prima during any Audit pursuant to clause 10.2(a), including answering any questions raised by Prima, and persons or corporations authorised by Prima to assist in the Audit, promptly and completely.

 

  (c) Prima will pay the cost of any Audit except that:

 

  (i) Prima will not reimburse Sydys for time spent by Sydys Personnel as a result of an Audit request;

 

10


  (ii) Sydys will not pay for the cost of retrieving records off-site for the purpose of an Audit; and

 

  (d) should an Audit reveal non-compliance by Sydys with any requirements under this Agreement (including any error in statements provided to Prima pursuant to Section 2.07 (g) (iv) of the Sub-License, License and Asset Purchase Agreement leading to underpayment by Sydys), all costs associated with the Audit will be borne by Sydys except for time spent by Prima Personnel.

 

11. Termination

 

11.1 Termination for cause

 

  (a) Either party may terminate this Agreement (in whole or part) with immediate effect at any time by giving written notice to the other party:

 

  (i) where the other party (the defaulting party ) commits a breach of a material clause of this Agreement, and that breach is not remedied within 90 (ninety) days of the defaulting party receiving a notice which requests that the breach be remedied; or

 

  (ii) if the other party (the “ Bankrupt Party ”) will file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets, or if the Bankrupt Party proposes a written agreement of composition or extension of its debts, or if the Bankrupt Party will be served with an involuntary petition in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or there will have been issued a warrant of attachment, execution, or similar process against it, filed in any insolvency proceeding, and the petition will not be dismissed within ninety (90) days after the filing thereof, or if the Bankrupt Party will propose or be a party to any dissolution or liquidation, or if the Bankrupt Party will make an assignment for the benefit of creditors.

 

  (b) Prima may terminate this Agreement (in whole or part) with immediate effect at any time by giving notice to Sydys where:

 

  (i) Sydys breaches its obligation pursuant to Section 6.01 of the Sub-License, License and Asset Purchase Agreement (including a deemed breach pursuant to Section 6.02 of the Sub-License, License and Asset Purchase Agreement);

 

  (ii) in Prima’s opinion, the acts or omissions of Sydys, any of its Personnel, or any of its Approved Sub-Licensees, bring or are likely to bring Prima into ridicule or disrepute or are contrary to the interests or stated positions of Prima; or

 

  (iii) it is entitled to terminate the Sub-License, License and Asset Purchase Agreement and/or the CVAC Sub-License each in accordance with its terms.

 

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11.2 Automatic termination

This Agreement terminates automatically (i) with respect to the Research Results by or on behalf of Prima generated under the Burnet License if the Burnet License is terminated for any reason whatsoever; (ii) and with respect to the CVAC Trademarks if the CVAC Trademarks expire.

 

11.3 Consequences of termination

 

  (a) On termination of this Agreement:

 

  (i) the (Sub-)License is immediately terminated;

 

  (ii) each party must immediately cease using the Confidential Information of the other party and return it to the other party in accordance with clause 7.3; and

 

  (iii) Sydys must immediately cease using the Licensed Know-How and CVAC Trademarks and return to Prima all copies of the Licensed Know-How and CVAC Trademarks in the possession, power or control of Sydys or any Approved Sub-Licensee.

 

  (b) Termination of this Agreement will not prejudice any rights or remedies already accrued to any party under, or in respect of any breach of, this Agreement.

 

11.4 Survival

Termination of this Agreement will not affect the operation of the provisions of this Agreement which by their nature survive termination or expiry of this Agreement.

 

12. Publicity

 

  (a) Sydys agrees not to issue any press release or make any public announcement relating to the subject matter of this Agreement without the prior consent of Prima, except as required by law or a court order.

 

  (b) Subject to any permitted disclosures under clause 12(a), Sydys agrees that it will not create the impression that any acts or omissions of Sydys or any Approved Sub-Licensee/Sub-Licensee in relation to the Licensed Know-How and CVAC Trademarks are authorised by Prima.

 

13. Dispute Resolution

 

  (a) The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiations, as follows. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Executives of each of the Parties shall meet at a mutually acceptable time and place within ten (10) days after delivery of such written notice, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the dispute. If the matter has not been resolved by these persons within fifteen (15) days of delivery of the disputing Party’s written notice, or if the Parties fail to meet within ten (10) days of delivery of written notice, any Party may initiate arbitration as provided hereinafter.

 

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  (i) Any dispute controversy or claim arising out of or relating to this Agreement, including the breach, termination or validity thereof, not resolved as hereinabove provided or otherwise by agreement between the Parties within forty-five (45) days of initiation of the dispute resolution procedures set forth in this Section 13, shall be finally resolved by binding arbitration in New York, New York in accordance with the American Arbitration Association Commercial Arbitration Rules then in effect pursuant to the following procedures:

 

  (ii) Except as otherwise specifically agreed upon by the Parties, the arbitration shall be heard and determined by three (3) arbitrators. Each Party shall appoint an arbitrator of its choice within thirty (30) days of the submission of a notice of arbitration. The Party-appointed arbitrators shall, within ten (10) business days following the appointment of both Party-appointed arbitrators, in turn appoint a third arbitrator who shall be the presiding arbitrator of the tribunal. If the Party-appointed arbitrators cannot reach agreement on a presiding arbitrator of the tribunal and/or one Party refuses to appoint its Party-appointed arbitrator within the thirty (30) day period, the American Arbitration Association shall appoint an independent arbitrator who does not have any financial interest in the dispute, controversy or claim. All decisions and awards by the arbitration tribunal shall be made by majority vote.

 

  (iii) The discovery rights of the Parties in connection with the arbitration shall be limited to the production of documents and, for the avoidance of doubt, no Party to such arbitration shall have any right to depose any other party or the officers, directors, employees, agents or other representatives of any other party to such arbitration (and the Arbitrators shall have no authority to compel any such deposition).

 

  (iv) Except as may otherwise be required by law or subpoena, the Parties (including their counsel and other representatives), the witnesses and the arbitrators shall not disclose the existence, contents or results of any arbitration conducted hereunder without the prior written consent of both Parties. Moreover, any documentary or other evidence produced in any arbitration hereunder shall be treated as confidential, and shall not be disclosed to any third party (other than a witness or expert as permitted herein), except as required by law or except if such evidence was obtained from the public domain or was otherwise obtained independently of the arbitration without breach of an independent duty of confidentiality or was lawfully in a Party’s possession.

 

  (v) Within 120 days of the appointment of the arbitration panel, the arbitrators shall hold hearings where written, documentary, and oral evidence may be presented. Evidence may not be taken except in the presence of both Parties, and all witnesses may be questioned by both Parties. Unless the Parties otherwise agree, or a witness is dead, ill or unavailable for other good reasons, the arbitrators shall not accept a witness’ written statement unless the other Party has an opportunity to question the witness in the arbitrators’ presence, or by telephonic or video telephonic communications. All proceedings shall be conducted in the English language.

 

  (vi)

The decision of the majority of the arbitrators shall be reduced to a writing, shall give factual and legal reasons for the decision(s) reached by the Arbitrators and shall be signed and dated by the arbitrators, and a copy of

 

13


  the Award shall be delivered to each of the Parties, within ninety (90) days of the completion of the arbitration hearing. The decision of the arbitrators shall be final and binding without the right of appeal; and shall be the sole and exclusive remedy regarding any claims, counterclaims, issues or accountings presented to the arbitrators. The arbitration award shall be made and promptly paid in currency of the transaction giving rise to the dispute, free of any deduction or offset through a bank in the United States. Any costs or fees incident to enforcing the award, shall to the maximum extent permitted by law, be charged against the Party resisting such enforcement. Consequential, punitive or other similar damages shall not be allowed. Each Party hereto waives to the fullest extent permitted by law any right it may otherwise have under the laws of any jurisdiction to any form of appeal of, or collateral attack against, such award. The prevailing Party shall be entitled to recover its costs of arbitration and reasonable attorneys’ fees, as determined by the arbitrators. The prevailing Party shall also be entitled to recover its costs and attorneys’ fees in any proceedings to enforce the award or to confirm judgment. The award shall include interest from the date of any breach or violation of the Agreement and/or Ancillary Agreement, as determined by the arbitral award, and from the date of the award until paid in full, at the then current Prime Rate, not to exceed the maximum permitted by law.

 

  (vii) Judgment upon the award may be entered in any court having jurisdiction over the person or the assets of the Party owing the judgment or application may be made to such court for a judicial acceptance of the award and an order of enforcement, as the case may be.

 

  (viii) Nothing in this Agreement shall prevent either Party from seeking any provisional/preliminary relief (including, but not limited to, injunctions, attachments or other such orders in aid of arbitration) from any court of competent jurisdiction, and any such application to a court for provisional/preliminary relief shall not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate.

 

14. General

 

14.1 Nature of obligations

Each obligation imposed on a party by this Agreement in favour of another is a separate obligation.

 

14.2 Entire understanding

 

  (a) This Agreement contains the entire understanding between the parties concerning the subject matter of the Agreement and supersedes all prior communications between the parties.

 

  (b) Each party acknowledges that, except as expressly stated in this Agreement, that party has not relied on any representation, warranty or undertaking of any kind made by or on behalf of the other party in relation to the subject matter of this Agreement.

 

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14.3 No adverse construction

This Agreement is not to be construed to the disadvantage of a party because that party was responsible for its preparation.

 

14.4 Further assurances

A party, at its own expense and within a reasonable time of being requested by another party to do so, must do all things and execute all documents that are reasonably necessary to give full effect to this Agreement.

 

14.5 No waiver

 

  (a) A failure, delay, relaxation or indulgence by a party in exercising any power or right conferred on the party by this Agreement does not operate as a waiver of the power or right.

 

  (b) A single or partial exercise of the power or right does not preclude a further exercise of it or the exercise of any other power or right under this Agreement.

 

  (c) A waiver of a breach does not operate as a waiver of any other breach.

 

14.6 Severability

Any provision of this Agreement 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 Agreement in any other case,

without invalidating or affecting the remaining provisions of this Agreement or the validity of that provision in any other jurisdiction.

 

14.7 Successors and assigns

This Agreement binds and benefits the parties and their respective successors and permitted assigns under clause 14.8.

 

14.8 No assignment

 

  (a) Sydys cannot assign or otherwise transfer the benefit of this Agreement without the prior written consent of Prima.

 

  (b) Prima may not assign or other transfer the benefit of this Agreement without the need for Sydys’ prior consent.

 

14.9 Consents and approvals

Where anything depends on the consent or approval of a party then, unless this Agreement provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

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14.10 No variation

This Agreement cannot be amended or varied except in writing signed by the parties.

 

14.11 Costs

Each party must pay its own legal costs of and incidental to the preparation and completion of this Agreement.

 

14.12 Governing law and jurisdiction

 

  (a) This Agreement is governed by and must be construed in accordance with the laws in force in New South Wales.

 

  (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 Agreement, its performance or subject matter.

 

14.13 Notices

Any notice or other communication to or by a party under this Agreement:

 

  (a) may be given by personal service, post or facsimile;

 

  (b) must be in writing, legible and in English addressed (depending on the manner in which it is given) as shown below:

 

  (i) If to Sydys :

 

  Address:    135 East 57th Street, 24th Floor, New York, NY 10022
  Attention:    Joseph Hernandez
  Email:    hernandez_joe@yahoo.com

 

  (ii) If to Prima:

 

  Address:    Level 12, 95 Pitt Street Sydney 2000, NSW, Australia
  Attention:    Mr Marc Voigt (CEO)
  Email:    marc.voigt@primabiomed.com.au
  Facsimile:    +61 2 8569 1880

or to any other address last notified by the party to the sender by notice given in accordance with this clause;

 

  (c) in the case of a corporation, must be signed by an officer or authorised representative of the sender or in accordance with section 127 of the Corporations Act; and

 

  (d) is deemed to be given by the sender and received by the addressee:

 

  (i) if delivered in person, when delivered to the addressee;

 

  (ii) if posted, 2 Business Days (or 6, if addressed outside Australia) after the date of posting to the addressee whether delivered or not; or

 

  (iii)

if sent by facsimile transmission, on the date and time shown on the transmission report by the machine from which the facsimile was sent

 

16


  which indicates that the facsimile was sent in its entirety and in legible form to the facsimile number of the addressee notified for the purposes of this clause,

but if the delivery or receipt is on a day which is not a Business Day or is after 4.00 pm (addressee’s time), it is deemed to have been received at 9.00 am on the next Business Day.

 

14.14 Counterparts

If this Agreement consists of a number of signed counterparts, each is an original and all of the counterparts together constitute the same document.

 

14.15 Conflicting provisions

If there is any conflict between the main body of this Agreement and any schedules or annexures comprising it, then the provisions of the main body of this Agreement prevail.

 

14.16 Non merger

A term or condition of, or act done in connection with, this Agreement does not operate as a merger of any of the rights or remedies of the parties under this Agreement and those rights and remedies continue unchanged.

 

14.17 Operation of indemnities

Unless this Agreement expressly provides otherwise:

 

  (a) each indemnity in this Agreement survives the expiry or termination of this Agreement; and

 

  (b) a party may recover a payment under an indemnity in this Agreement before it makes the payment in respect of which the indemnity is given.

 

14.18 No right of set-off

Unless this Agreement expressly provides otherwise, a party has no right of set-off against a payment due to another party.

 

14.19 Relationship of parties

Unless this Agreement expressly provides otherwise, nothing in this Agreement may be construed as creating a relationship of partnership, of principal and agent or of trustee and beneficiary.

 

17


Executed as an Agreement.

 

Executed by Prima BioMed Limited ACN 009 237 889 in accordance with section 127(1) of

the Corporations Act 2001 (Cth):

    

 

Signature of director

    

 

Signature of director or company secretary*

     *delete whichever does not apply

 

Name (please print)

    

 

Name (please print)

Executed by Sydys in accordance with section 127(1) of the Corporations Act 2001 (Cth):     

 

Signature of director

    

 

Signature of director or company secretary*

     *delete whichever does not apply

 

Name (please print)

    

 

Name (please print)

 

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Annexure A:

List of trademarks, trade names and logos licensed by Prima from Prima Biomed IP Pty Ltd.:

 

Country

  

Registration number

Australia    1315870
China    8079372
Europe    008897266
New Zealand    819756
United Arab Emirates    129666
United States of America    4097536

 

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Exhibit D

New License Agreement

Prima BioMed Ltd

ACN 009 237 889

and

Sydys Corporation


Table of Contents

 

1.      Definitions and interpretation      1   
2.      License      3   
3.      Licensed Developments Obligations      4   
4.      Notification      4   
5.      Payment obligations      5   
6.      GST      5   
7.      Confidentiality      6   
8.      No warranties      7   
9.      Liability and indemnities      7   
10.      Audit      8   
11.      Termination      8   
12.      Publicity      9   
13.      Dispute Resolution      9   
14.      General      11   


New License Agreement

Date                              11 / 12 May 2016

Parties

 

1. Prima BioMed Ltd ACN 009 237 889 of Level 12, 95 Pitt Street, Sydney, New South Wales 2000 ( Prima )

 

2. Sydys Corporation , 135 East 57th Street, 24th Floor, New York, NY 10022 ( Sydys )

Background

 

A. Sydys has concluded a Sub-License, License and Asset Purchase Agreement with Prima executed 12 May 2016 (“ Sub-License, License and Asset Purchase Agreement ”) to which this Agreement is Exhibit D.

 

B. Sydys has agreed under the Sub-License, License and Asset Purchase Agreement to grant Prima a non-exclusive worldwide license for patents and patent applications held and filed by Sydys, respectively, know-how Controlled by Sydys and documentation in Sydys’ possession, in each case related to the Covered Products to the extent permitted by Law on the terms of this Agreement.

Agreed terms

 

1. Definitions and interpretation

 

1.1 Definitions

In this Agreement:

Agreement means this agreement including the background, any schedules and any annexures;

Business Day means a day that is not a Saturday, Sunday, public holiday or bank holiday in Sydney, New South Wales;

Commencement Date means 12 May 2016;

Confidential Information means any and all information of any nature and in any form (including electronic, magnetic and other intangible forms, whether capable of being read by human beings or not) concerning the operations, dealings, organisation, personnel, business strategies, customers, technology, Intellectual Property Rights, trade secrets or know-how of a person which is received by, disclosed to or discovered by the other party ( Receiving Party ) before, on or after the Commencement Date under, in connection with or as a result of this Agreement, any of the matters dealt with in this Agreement or any action taken under this Agreement, but does not include information which:

 

  (a) is or becomes part of the public domain through no act, failure to act or default of the Receiving Party or any person associated with, or who received that information from or as a consequence of disclosure by, the Receiving Party;


  (b) is disclosed to the Receiving Party by a third party lawfully in possession of such information and who is not under any obligation to maintain such information in confidence; or

 

  (c) is developed independently by the Receiving Party without use of or reference to the other party’s information.

Corporations Act means the Corporations Act 2001 (Cth) ;

CVAC Sub-License means the exclusive license agreement between Prima and Sydys entered into pursuant to the Sub-License, License and Asset Purchase Agreement in the form set out in Exhibit B to the Sub-License, License and Asset Purchase Agreement.

Dispute means any dispute or difference of opinion between the parties, or the absence of agreement by the parties, about a matter under or arising out of this Agreement;

Dispute Notice means a notice from Sydys or Prima to the other relating to a Dispute:

 

  (a) requiring the Dispute to be resolved under clause 13; and

 

  (b) outlining the issues which are the subject of the Dispute;

Improvements means any amendments, changes or additions made by Sydys to any part of the CVAC Know-How (as defined in the Know-How License) and the CVAC Intellectual Property (as defined in the CVAC Sub-License);

Know-How License means the non-exclusive license agreement between Prima and Sydys entered into pursuant to the Sub-License, License and Asset Purchase Agreement in the form set out in Exhibit C to the Sub-License, License and Asset Purchase Agreement.

Personnel means any employees, agents and approved contractors of a party;

Related Body Corporate has the meaning given to that term in the Corporations Act;

Resolution Period means a 20 Business Day period after a Dispute Notice relating to a Dispute is given; and

Definitions which are not defined in this Agreement shall have the meaning as defined in the Sub-License, License and Asset Purchase Agreement.

 

1.2 Interpretation

In this Agreement unless the context requires otherwise:

 

  (a) the singular includes the plural and vice versa;

 

  (b) a gender includes the other genders;

 

  (c) the headings are used for convenience only and do not affect the interpretation of this Agreement;

 

  (d) other grammatical forms of defined words or expressions have corresponding meanings;

 

2


  (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 Agreement 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 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;

 

  (l) 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)”;

 

  (m) money amounts are stated in Australian currency unless otherwise specified;

 

  (n) a reference to time is to Sydney, New South Wales, Australia time;

 

  (o) 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; and

 

  (p) any agreement, 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.

 

2. License

 

2.1 License

Subject to the terms of this Agreement (to the extent permitted by Law), Sydys grants to Prima a non-exclusive, transferable license for any patents and patent applications held and filed by Sydys, respectively, know-how Controlled by Sydys and documentation in Sydys’ possession, in each case related to the Covered Products and for any Improvements of the CVAC Know-How (as defined in the Know-How License Agreement) and Improvements of the CVAC Intellectual Property (as defined in the CVAC Sub-License) with effect from the Commencement Date (the “ Licensed Developments ”).

 

3


2.2 Acknowledgment

Prima acknowledges and agrees that the Licensed Developments are, and will remain the exclusive property of Sydys and that nothing in this Agreement will be construed as transferring title in or ownership of any Licensed Developments to Prima.

 

3. Licensed Developments Obligations

 

3.1 Sydys’ obligation

Sydys will provide to Prima written annual reports, containing a list and the progress of the Licensed Developments.

 

3.2 Prima obligations

 

  (a) Prima shall not use the Licensed Developments to commercialise and develop the CVAC products and the New CVAC Products anywhere in the world as long as Sydys has not in breach pursuant to Sections 6.01 and/or 6.02 of the Sub-License, License and Asset Purchase Agreement.

 

  (b) Prima shall not grant any sub-licenses to the Licensed Developments as long as Sydys is not in breach pursuant to Section 6.01 and/or 6.02 of the Sub-License, License and Asset Purchase Agreement.

 

3.3 Improvements

All right and title in any and all Improvements belong to Sydys and shall be subject to the Licensed Developments under Section 2.1.

 

4. Notification

 

  (a) Sydys will immediately notify Prima, with full particulars available, if Sydys learns:

 

  (i) of any infringement or potential infringement of any of the Licensed Developments by a third party;

 

  (ii) that the use of any of the Licensed Developments may infringe the proprietary rights of a third party;

 

  (iii) of any other claims or potential claims against Prima or Sydys in any way relating to any of the Licensed Developments (including relating to its use, development or commercialisation), including without limitation:

 

  (A) any claim by a third party for personal injury, death or property damage;

 

  (B) any defects in any products and/or services provided by Sydys which use or incorporate any Licensed Developments; or

 

  (C) the need for any recall of any products developed or sold by Sydys which use or incorporate any of the Licensed Developments; or

 

  (iv) of any wilful, unlawful or negligent act or omission of Sydys, any of its Personnel.

 

4


  (b) In connection with any infringement or potential infringement of or by the Licensed Developments, Prima will:

 

  (i) provide all information and assistance to Sydys; and

 

  (ii) not take steps on its own without Sydys’ prior approval.

 

5. Payment obligations

Prima is not obliged to pay any consideration for the grant of the New License.

 

6. GST

 

6.1 Definitions

In this Agreement:

 

  (a) the expressions Consideration , GST , Input Tax Credit , Recipient , Supply , Tax Invoice and Taxable Supply have the meanings given to those expressions in the A New Tax System (Goods and Services Tax) Act 1999 ( GST Act ); and

 

  (b) Supplier means any party treated by the GST Act as making a Supply under this Agreement.

 

6.2 Consideration is GST exclusive

Unless otherwise expressly stated, all prices or other sums payable or Consideration to be provided under or in accordance with this Agreement are exclusive of GST.

 

6.3 Payment of GST

 

  (a) If GST is imposed on any Supply made under or in accordance with this Agreement, the Recipient of the Taxable Supply must pay to the Supplier an additional amount equal to the GST payable on or for the Taxable Supply, subject to the Recipient receiving a valid Tax Invoice in respect of the Supply at or before the time of payment.

 

  (b) Payment of the additional amount must be made at the same time and in the same way as payment for the Taxable Supply is required to be made in accordance with this Agreement.

 

6.4 Reimbursement of expenses

If this Agreement requires a party (the First Party) to pay for, reimburse, set off or contribute to any expense, loss or outgoing (Reimbursable Expense) suffered or incurred by the other party (the Other Party), the amount required to be paid, reimbursed, set off or contributed by the First Party will be the sum of:

 

  (a) the amount of the Reimbursable Expense net of Input Tax Credits (if any) to which the Other Party is entitled in respect of the Reimbursable Expense (Net Amount); and

 

  (b) if the Other Party’s recovery from the First Party is a Taxable Supply, any GST payable in respect of that Supply,

 

5


such that after the Other Party meets the GST liability, it retains the Net Amount. The costs (e.g. annual renewal fees) to maintain the patents will be directly or indirectly borne by Sydys.

 

7. Confidentiality

 

7.1 Obligations of confidentiality

Each party ( Receiving Party ) receiving, possessing or otherwise acquiring Confidential Information of any other party ( Disclosing Party ) acknowledges that the Disclosing Party’s Confidential Information is the property of and confidential to or a trade secret of the Disclosing Party. Subject to clause 7.2, the Receiving Party must:

 

  (a) keep the Disclosing Party’s Confidential Information confidential and not directly or indirectly disclose, divulge or communicate that Confidential Information to, or otherwise place that Confidential Information at the disposal of, any other person without the prior written approval of the Disclosing Party;

 

  (b) take all reasonable steps to secure and keep secure all Disclosing Party’s Confidential Information coming into its possession or control; and

 

  (c) not memorise, use, modify, reverse engineer or make copies, notes or records of the Disclosing Party’s Confidential Information for any purpose other than in connection with the performance by the Receiving Party of its obligations under this Agreement.

 

7.2 Exceptions

The obligations of confidentiality under clause 7.1 do not apply to any information that is required to be disclosed by any applicable law or any order of any court, tribunal, authority or regulatory body (but only to the extent that it required to be disclosed).

 

7.3 Return of information

 

  (a) In relation to material containing Confidential Information, the Receiving Party must on demand, or at the expiry or termination of this Agreement:

 

  (i) promptly return to the Disclosing Party any of such material supplied to or received by the Receiving Party or any of its Personnel; or

 

  (ii) if required, destroy any of such material supplied to or received by the Receiving Party or any of its Personnel and supply certification of such destruction where requested.

 

  (b) Despite anything else in this Agreement, the Receiving Party may retain in its files copies of the Confidential Information to the extent the Confidential Information forms part of any board papers or accompanying memoranda submitted to, or the subject of presentations at, meetings of the board of directors of the Receiving Party or its Related Body Corporate or any minutes of meetings of the board of directors of the Receiving Party or its Related Body Corporate.

 

  (c)

Notwithstanding anything to the contrary in this Agreement, it is understood and agreed that the Receiving Party’s computer systems may automatically back-up the Confidential Information disclosed to it under this Agreement. To the extent that any computer back-up procedures create copies of the Confidential

 

6


  Information ( Back-up Copies ), the Receiving Party may retain any Back-up Copies in its archival or back-up computer storage for the period it normally archives backed-up computer records. Any Back-up Copies will be subject to the provisions of this Agreement until the same are destroyed, and must not be accessed by the Receiving Party during any period of archival or back-up storage other than as permitted under this Agreement.

 

8. No warranties

Prima acknowledges that:

 

  (a) the use of the Licensed Developments and all other material (including Confidential Information) provided to Prima is at its own risk; and

 

  (b) to the maximum extent permitted by law the Licensed Developments is licensed, and all material (including Confidential Information) is provided, to Prima “as is”, without warranties of any kind (whether express, implied, statutory or otherwise), including with respect to non-infringement of third party rights (including intellectual property rights), merchantability, completeness, reliability, quality or fitness for any particular purpose other than the warranties provided in Article IV of the Sub-License, License and Asset Purchase Agreement.

 

9. Liability and indemnities

 

9.1 Limitation on liability

To the maximum extent permitted by law but not in contradiction to Section 7.03 and 7.04 of the Sub-License, License and Asset Purchase Agreement, Sydys will not be liable to Prima or any third party in respect of any loss or damage (including, without limitation, any indirect or consequential loss, loss of profit or loss of revenue) however so caused, whether based on contract, tort (including negligence), statute or any other legal theory, arising directly or indirectly in connection with this Agreement, including in respect of the use, commercialisation or the development of the Licensed Developments.

 

9.2 Prima’s indemnity

Subject to Section 7.02 and 7.04 of the Sub-License, License and Asset Purchase Agreement, Prima will indemnify and hold harmless Sydys and its Personnel (each an “Indemnified Party”) from and against any and all losses, damages, costs and expenses (including all reasonable legal fees) (each a “Loss”) incurred by an Indemnified Party arising directly or indirectly from:

 

  (a) Prima’s breach of any term of this Agreement (including any representation or warranty provided under this Agreement);

 

  (b) any wilful, unlawful or negligent act or omission of Prima or any of its Personnel; or

 

  (c) Prima’s use, commercialisation or development of the Licensed Developments, any:

 

  (i) defects in any products and/or services provided by Prima which use or incorporate any Licensed Developments;

 

  (ii) infringement by Prima of any third party’s intellectual property rights;

 

7


  (iii) claim by a third party for personal injury, death or property damage; or

 

  (iv) recall of any products developed or sold by Prima which use or incorporate any of the Licensed Developments.

 

10. Audit

 

10.1 Sydys must permit Prima and persons or corporations authorised by Prima (including, if Prima so elects, Prima’s external registered auditors) to have access to the books and records of Sydys insofar as they relate to this Agreement, on Business Days between 9am until 5pm upon reasonable notice being given to Sydys (Audit). Any information obtained in exercise of the rights of this clause must be kept confidential by Prima and its external auditor and not used or disclosed for any other purpose except for the purposes allowed by this Agreement.

 

10.2 Sydys must cooperate with Prima during any Audit pursuant to clause 10.1, including answering any questions raised by Prima, and persons or corporations authorised by Prima to assist in the Audit, promptly and completely.

 

10.3 Prima will pay the cost of any Audit except that:

 

  (a) Prima will not reimburse Sydys for time spent by Sydys Personnel as a result of an Audit request;

 

  (b) Sydys will not pay for the cost of retrieving records off-site for the purpose of an Audit; and

 

10.4 should an Audit reveal non-compliance by Sydys with any requirements under this Agreement, all costs associated with the Audit will be borne by Sydys except for time spent by Prima Personnel.

 

11. Termination

 

11.1 Termination for cause

 

  (a) Either party may terminate this Agreement (in whole or part) with immediate effect at any time by giving written notice to the other party where the other party (the defaulting party ) commits a breach of a material clause of this Agreement, and that breach is not remedied within 90 (ninety) days of the defaulting party receiving a notice which requests that the breach be remedied.

 

  (b) Either Party may terminate this Agreement if the other Party (the “ Bankrupt Party ”) will file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Bankrupt Party or of its assets, or if the Bankrupt Party proposes a written agreement of composition or extension of its debts, or if the Bankrupt Party will be served with an involuntary petition in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or there will have been issued a warrant of attachment, execution, or similar process against it, filed in any insolvency proceeding, and the petition will not be dismissed within ninety (90) days after the filing thereof, or if the Bankrupt Party will propose or be a party to any dissolution or liquidation, or if the Bankrupt Party will make an assignment for the benefit of creditors.

 

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11.2 Consequences of termination

 

  (a) On termination of this Agreement:

 

  (i) the New License is immediately terminated;

 

  (ii) each party must immediately cease using the Confidential Information of the other party and return it to the other party in accordance with clause 7.3; and

 

  (iii) Prima must immediately cease using the Licensed Developments and return to Sydys all copies of the Licensed Developments in the possession, power or control of Prima.

 

  (b) Termination of this Agreement will not prejudice any rights or remedies already accrued to any party under, or in respect of any breach of, this Agreement.

 

11.3 Survival

Termination of this Agreement will not affect the operation of the provisions of this Agreement which by their nature survive termination or expiry of this Agreement.

 

11.4 Termination of the Sub-License, License and Asset Purchase Agreement

The termination of the Sub-License, License and Asset Purchase Agreement does not result in an automatic termination of this Agreement and does not constitute a ground for terminating this Agreement.

 

12. Publicity

 

  (a) The parties agree not to issue any press release or make any public announcement relating to the subject matter of this Agreement without the prior consent of the other party, except as required by law or a court order.

 

  (b) Subject to any permitted disclosures under clause 12(a), Prima agrees that it will not create the impression that any acts or omissions of Prima in relation to the Licensed Developments are authorised by Sydys.

 

13. Dispute Resolution

 

  (a) The Parties shall attempt in good faith to resolve any dispute arising out of or relating to this Agreement promptly by negotiations, as follows. Any Party may give the other Party written notice of any dispute not resolved in the normal course of business. Executives of each of the Parties shall meet at a mutually acceptable time and place within ten (10) days after delivery of such written notice, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the dispute. If the matter has not been resolved by these persons within fifteen (15) days of delivery of the disputing Party’s written notice, or if the Parties fail to meet within ten (10) days of delivery of written notice, any Party may initiate arbitration as provided hereinafter.

 

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  (i) Any dispute controversy or claim arising out of or relating to this Agreement, including the breach, termination or validity thereof, not resolved as hereinabove provided or otherwise by agreement between the Parties within forty-five (45) days of initiation of the dispute resolution procedures set forth in this Section 13, shall be finally resolved by binding arbitration in New York, New York in accordance with the American Arbitration Association Commercial Arbitration Rules then in effect pursuant to the following procedures:

 

  (ii) Except as otherwise specifically agreed upon by the Parties, the arbitration shall be heard and determined by three (3) arbitrators. Each Party shall appoint an arbitrator of its choice within thirty (30) days of the submission of a notice of arbitration. The Party-appointed arbitrators shall, within ten (10) business days following the appointment of both Party-appointed arbitrators, in turn appoint a third arbitrator who shall be the presiding arbitrator of the tribunal. If the Party-appointed arbitrators cannot reach agreement on a presiding arbitrator of the tribunal and/or one Party refuses to appoint its Party-appointed arbitrator within the thirty (30) day period, the American Arbitration Association shall appoint an independent arbitrator who does not have any financial interest in the dispute, controversy or claim. All decisions and awards by the arbitration tribunal shall be made by majority vote.

 

  (iii) The discovery rights of the Parties in connection with the arbitration shall be limited to the production of documents and, for the avoidance of doubt, no Party to such arbitration shall have any right to depose any other party or the officers, directors, employees, agents or other representatives of any other party to such arbitration (and the Arbitrators shall have no authority to compel any such deposition).

 

  (iv) Except as may otherwise be required by law or subpoena, the Parties (including their counsel and other representatives), the witnesses and the arbitrators shall not disclose the existence, contents or results of any arbitration conducted hereunder without the prior written consent of both Parties. Moreover, any documentary or other evidence produced in any arbitration hereunder shall be treated as confidential, and shall not be disclosed to any third party (other than a witness or expert as permitted herein), except as required by law or except if such evidence was obtained from the public domain or was otherwise obtained independently of the arbitration without breach of an independent duty of confidentiality or was lawfully in a Party’s possession.

 

  (v) Within 120 days of the appointment of the arbitration panel, the arbitrators shall hold hearings where written, documentary, and oral evidence may be presented. Evidence may not be taken except in the presence of both Parties, and all witnesses may be questioned by both Parties. Unless the Parties otherwise agree, or a witness is dead, ill or unavailable for other good reasons, the arbitrators shall not accept a witness’ written statement unless the other Party has an opportunity to question the witness in the arbitrators’ presence, or by telephonic or video telephonic communications. All proceedings shall be conducted in the English language.

 

  (vi)

The decision of the majority of the arbitrators shall be reduced to a writing, shall give factual and legal reasons for the decision(s) reached by the Arbitrators and shall be signed and dated by the arbitrators, and a copy of

 

10


  the Award shall be delivered to each of the Parties, within ninety (90) days of the completion of the arbitration hearing. The decision of the arbitrators shall be final and binding without the right of appeal; and shall be the sole and exclusive remedy regarding any claims, counterclaims, issues or accountings presented to the arbitrators. The arbitration award shall be made and promptly paid in currency of the transaction giving rise to the dispute, free of any deduction or offset through a bank in the United States. Any costs or fees incident to enforcing the award, shall to the maximum extent permitted by law, be charged against the Party resisting such enforcement. Consequential, punitive or other similar damages shall not be allowed. Each Party hereto waives to the fullest extent permitted by law any right it may otherwise have under the laws of any jurisdiction to any form of appeal of, or collateral attack against, such award. The prevailing Party shall be entitled to recover its costs of arbitration and reasonable attorneys’ fees, as determined by the arbitrators. The prevailing Party shall also be entitled to recover its costs and attorneys’ fees in any proceedings to enforce the award or to confirm judgment. The award shall include interest from the date of any breach or violation of the Agreement and/or Ancillary Agreement, as determined by the arbitral award, and from the date of the award until paid in full, at the then current Prime Rate, not to exceed the maximum permitted by law.

 

  (vii) Judgment upon the award may be entered in any court having jurisdiction over the person or the assets of the Party owing the judgment or application may be made to such court for a judicial acceptance of the award and an order of enforcement, as the case may be.

 

  (viii) Nothing in this Agreement shall prevent either Party from seeking any provisional/preliminary relief (including, but not limited to, injunctions, attachments or other such orders in aid of arbitration) from any court of competent jurisdiction, and any such application to a court for provisional/preliminary relief shall not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate.

 

14. General

 

14.1 Nature of obligations

Each obligation imposed on a party by this Agreement in favour of another is a separate obligation.

 

14.2 Entire understanding

 

  (a) This Agreement contains the entire understanding between the parties concerning the subject matter of the Agreement and supersedes all prior communications between the parties.

 

  (b) Each party acknowledges that, except as expressly stated in this Agreement, that party has not relied on any representation, warranty or undertaking of any kind made by or on behalf of the other party in relation to the subject matter of this Agreement.

 

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14.3 No adverse construction

This Agreement is not to be construed to the disadvantage of a party because that party was responsible for its preparation.

 

14.4 Further assurances

A party, at its own expense and within a reasonable time of being requested by another party to do so, must do all things and execute all documents that are reasonably necessary to give full effect to this Agreement.

 

14.5 No waiver

 

  (a) A failure, delay, relaxation or indulgence by a party in exercising any power or right conferred on the party by this Agreement does not operate as a waiver of the power or right.

 

  (b) A single or partial exercise of the power or right does not preclude a further exercise of it or the exercise of any other power or right under this Agreement.

 

  (c) A waiver of a breach does not operate as a waiver of any other breach.

 

14.6 Severability

Any provision of this Agreement 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 Agreement in any other case,

without invalidating or affecting the remaining provisions of this Agreement or the validity of that provision in any other jurisdiction.

 

14.7 Successors and assigns

This Agreement binds and benefits the parties and their respective successors and permitted assigns under clause 14.8.

 

14.8 No assignment

 

  (a) Prima cannot assign or otherwise transfer the benefit of this Agreement without the prior written consent of Sydys.

 

  (b) Sydys may not assign or other transfer the benefit of this Agreement without the need for Prima’s prior consent.

 

14.9 Consents and approvals

Where anything depends on the consent or approval of a party then, unless this Agreement provides otherwise, that consent or approval may be given conditionally or unconditionally or withheld, in the absolute discretion of that party.

 

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14.10 No variation

This Agreement cannot be amended or varied except in writing signed by the parties.

 

14.11 Costs

Each party must pay its own legal costs of and incidental to the preparation and completion of this Agreement.

 

14.12 Governing law and jurisdiction

 

  (a) This Agreement is governed by and must be construed in accordance with the laws in force in New South Wales.

 

  (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 Agreement, its performance or subject matter.

 

14.13 Notices

Any notice or other communication to or by a party under this Agreement:

 

  (a) may be given by personal service, post or facsimile;

 

  (b) must be in writing, legible and in English addressed (depending on the manner in which it is given) as shown below:

 

  (i) If to Sydys :

 

  Address:    135 East 57th Street, 24th Floor, New York, NY 10022
  Attention:    Joseph Hernandez
  Email:    hernandez_joe@yahoo.com

 

  (ii) If to Prima:

 

  Address:    Level 12, 95 Pitt Street Sydney 2000, NSW, Australia
  Attention:    Mr Marc Voigt (CEO)
  Email:    marc.voigt@primabiomed.com.au
  Facsimile:    +61 2 8569 1880

or to any other address last notified by the party to the sender by notice given in accordance with this clause;

 

  (c) in the case of a corporation, must be signed by an officer or authorised representative of the sender or in accordance with section 127 of the Corporations Act; and

 

  (d) is deemed to be given by the sender and received by the addressee:

 

  (i) if delivered in person, when delivered to the addressee;

 

  (ii) if posted, 2 Business Days (or 6, if addressed outside Australia) after the date of posting to the addressee whether delivered or not; or

 

  (iii)

if sent by facsimile transmission, on the date and time shown on the transmission report by the machine from which the facsimile was sent

 

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  which indicates that the facsimile was sent in its entirety and in legible form to the facsimile number of the addressee notified for the purposes of this clause,

but if the delivery or receipt is on a day which is not a Business Day or is after 4.00 pm (addressee’s time), it is deemed to have been received at 9.00 am on the next Business Day.

 

14.14 Counterparts

If this Agreement consists of a number of signed counterparts, each is an original and all of the counterparts together constitute the same document.

 

14.15 Conflicting provisions

If there is any conflict between the main body of this Agreement and any schedules or annexures comprising it, then the provisions of the main body of this Agreement prevail.

 

14.16 Non merger

A term or condition of, or act done in connection with, this Agreement does not operate as a merger of any of the rights or remedies of the parties under this Agreement and those rights and remedies continue unchanged.

 

14.17 Operation of indemnities

Unless this Agreement expressly provides otherwise:

 

  (a) each indemnity in this Agreement survives the expiry or termination of this Agreement; and

 

  (b) a party may recover a payment under an indemnity in this Agreement before it makes the payment in respect of which the indemnity is given.

 

14.18 No right of set-off

Unless this Agreement expressly provides otherwise, a party has no right of set-off against a payment due to another party.

 

14.19 Relationship of parties

Unless this Agreement expressly provides otherwise, nothing in this Agreement may be construed as creating a relationship of partnership, of principal and agent or of trustee and beneficiary.

 

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Executed as an Agreement.

 

Executed by Prima BioMed Limited ACN 009 237 889 in accordance with section 127(1) of the Corporations Act 2001 (Cth):     

 

    

 

Signature of director      Signature of director or company secretary*
     *delete whichever does not apply

 

    

 

Name (please print)      Name (please print)

 

Executed by Sydys in accordance with section 127(1) of the Corporations Act 2001 (Cth):   

 

  

 

Signature of director    Signature of director or company secretary*
   *delete whichever does not apply

 

  

 

Name (please print)    Name (please print)

 

15

Exhibit 12.1

Certification of the Chief Executive Officer and Chief Financial Officer as required by

Rule 13a-14(a) of the Securities Exchange Act of 1934

I, Marc Voigt, certify that:

 

  1. I have reviewed this annual report on Form 20-F of Prima BioMed Ltd;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;

 

  4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under my supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under my supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report my conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and


  5. I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

Date: October 3, 2016

 

/s/ Marc Voigt

Marc Voigt
Chief Executive Officer
Chief Financial Officer

Exhibit 13.1

Certification of the Chief Executive Officer and Chief Financial Officer as required by

Rule 13a-14(b) of the Securities Exchange Act of 1934

Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Marc Voigt, Chief Executive Officer and Chief Financial Officer of Prima BioMed Ltd (the “Company”), hereby certifies that, to the best of his knowledge:

 

  1. The Company’s Annual Report on Form 20-F for the period ended June 30, 2016, to which this Certification is attached as Exhibit 13.1 (the “Annual Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and

 

  2. The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: October 3, 2016

/s/ Marc Voigt

Marc Voigt
Chief Executive Officer
Chief Financial Officer

This certification accompanies the Form 20-F to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Prima BioMed Ltd under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 20-F), irrespective of any general incorporation language contained in such filing.

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.