As filed with the Securities and Exchange Commission on June 25, 2014

Registration No. 333-196539

 

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 2

TO

FORM S-1

REGISTRATION STATEMENT

Under

The Securities Act of 1933

 

 

PFENEX INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   2834   27-1356759

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

10790 Roselle Street

San Diego, CA 92121

(858) 352-4400

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

 

Bertrand C. Liang

Chief Executive Officer

Pfenex Inc.

10790 Roselle Street

San Diego, CA 92121

(858) 352-4400

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

 

Jeffrey D. Saper

Daniel R. Koeppen

Wilson Sonsini Goodrich & Rosati

Professional Corporation

12235 El Camino Real, Suite 200

San Diego, CA 92130

(858) 350-2300

 

Paul A. Wagner

Chief Financial Officer

Pfenex Inc.

10790 Roselle Street

San Diego, CA 92121

(858) 352-4400

 

 

Christopher Lueking

Latham & Watkins LLP

330 North Wabash Avenue, Suite 2800

Chicago, IL 60611

(312) 876-7700

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box.   ¨

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.   ¨

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.   ¨

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.   ¨

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

 

Large accelerated filer   ¨

    Accelerated filer   ¨

Non-accelerated filer   x

 

    (do not check if a smaller reporting company)

  Smaller reporting company   ¨

 

 

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to such section 8(a) may determine.

 

 

 


EXPLANATORY NOTE

This Amendment No. 2 to the Registration Statement on Form S-1 (File No. 333-196539) of Pfenex Inc. is being filed solely for the purpose of filing certain exhibits as indicated in Part II of this Amendment No. 2. This Amendment No. 2 does not modify the prospectus that forms a part of the Registration Statement or Items 13, 14, 15 or 17 of Part II of the Registration Statement. Accordingly, a preliminary prospectus has been omitted.


PART II

INFORMATION NOT REQUIRED IN THE PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth the various expenses, other than underwriting discounts and commissions, payable by the Registrant in connection with the sale of common stock being registered. All of the amounts shown are estimated except the Securities and Exchange Commission registration fee and the FINRA filing fee.

 

     Amount To Be Paid  

SEC registration fee

   $                   *   

FINRA filing fee

         *   

NYSE listing fee

         *   

Printing and engraving expenses

         *   

Legal fees and expenses

         *   

Accounting fees and expenses

         *   

Blue sky fees and expenses

         *   

Transfer agent and registrar fees

         *   

Miscellaneous fees and expenses

         *   
  

 

 

 

Total

   $                            
  

 

 

 

 

* To be completed by amendment

Item 14. Indemnification of Directors and Officers.

Registrant is a Delaware corporation. Section 145(a) of the Delaware General Corporation Law, or the DGCL, provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, other than an action by or in the right of the corporation, by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorney fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful.

Section 145(b) of the DGCL provides that a Delaware corporation may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that such person acted in any of the capacities set forth above, against expenses (including attorney fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation, unless and only to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine that, despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnification for such expenses which the court shall deem proper.

 

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Further subsections of DGCL Section 145 provide that:

(1)        to the extent a present or former director or officer of a corporation has been successful on the merits or otherwise in the defense of any action, suit or proceeding referred to in subsections (a) and (b) of Section 145 or in the defense of any claim, issue or matter therein, such person shall be indemnified against expenses, including attorneys’ fees, actually and reasonably incurred by such person in connection therewith;

(2)        the indemnification and advancement of expenses provided for pursuant to Section 145 shall not be deemed exclusive of any other rights to which those seeking indemnification or advancement of expenses may be entitled under any bylaw, agreement, vote of stockholders or disinterested directors or otherwise; and

(3)        the corporation shall have the power to purchase and maintain insurance of behalf of any person who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against any liability asserted against such person and incurred by such person in any such capacity, or arising out of such person’s status as such, whether or not the corporation would have the power to indemnify such person against such liability under Section 145.

As used in this Item 14, the term “proceeding” means any threatened, pending, or completed action, suit, or proceeding, whether or not by or in the right of Registrant, and whether civil, criminal, administrative, investigative or otherwise.

Section 145 of the DGCL makes provision for the indemnification of officers and directors in terms sufficiently broad to indemnify officers and directors of Registrant under certain circumstances from liabilities (including reimbursement for expenses incurred) arising under the Securities Act of 1933, as amended, or the Securities Act. Registrant’s Amended and Restated Certificate of Incorporation provides, in effect, that, to the fullest extent and under the circumstances permitted by Section 145 of the DGCL, registrant will indemnify any and all of its executive officers and directors. Before the completion of this offering, registrant intends to enter into indemnification agreements with its directors, executive officers and certain other officers. Registrant may, in its discretion, similarly indemnify its employees and agents. Registrant’s Amended and Restated Certificate also relieves its directors from monetary damages to Registrant or its stockholders for breach of such director’s fiduciary duty as a director to the fullest extent permitted by the DGCL. Under Section 102(b)(7) of the DGCL, a corporation may relieve its directors from personal liability to such corporation or its stockholders for monetary damages for any breach of their fiduciary duty as directors except (i) for a breach of the duty of loyalty, (ii) for failure to act in good faith, (iii) for intentional misconduct or knowing violation of law, (iv) for willful or negligent violations of certain provisions in the DGCL imposing certain requirements with respect to stock repurchases, redemptions and dividends, or (v) for any transactions from which the director derived an improper personal benefit.

We intend to enter into indemnification agreements with each of our directors, executive officers and certain other officers that provide, in general, that we will indemnify them to the fullest extent permitted by law in connection with their service to us or on our behalf.

Registrant has purchased insurance policies which, within the limits and subject to the terms and conditions thereof, cover certain expenses and liabilities that may be incurred by directors and officers in connection with proceedings that may be brought against them as a result of an act or omission committed or suffered while acting as a director or officer of registrant.

 

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Item 15. Recent Sales of Unregistered Securities.

Since January 1, 2011, we have made the following sales of unregistered securities:

 

  1. Since January 1, 2011, the registrant has granted to its directors, officers, employees and consultants options to purchase 1,317,956 shares of common stock under its 2009 Equity Incentive Plan with per share exercise prices ranging from $0.23 to $4.12.
  2. Since January 1, 2011, the registrant issued and sold an aggregate of 306,000 shares of its common stock upon the exercise of options issued to certain employees, directors and consultants under the registrant’s 2009 Stock Incentive Plan at exercise prices ranging from $0.11 to $ 0.529, for aggregate consideration of $38,688.00.

The sales of the above securities were deemed to be exempt from registration under the Securities Act in reliance upon Section 4(2) of the Securities Act, Regulation D or Regulation S promulgated thereunder, or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering or pursuant to benefit plans and contracts relating to compensation as provided under Rule 701.

Item 16. Exhibits and Financial Statement Schedules.

 

  (a) Exhibits

See Exhibit Index immediately following the Signature Pages.

(b)          No financial statement schedules are provided because the information called for is not required or is shown in the financial statements or the notes thereto.

Item 17. Undertakings.

(a)          The undersigned registrant hereby undertakes to provide to the underwriters at the closing date specified in the underwriting agreements certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

(b)          Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of their counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by them is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

(c)           The undersigned Registrant hereby undertakes that:

(1)          For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be a part of this registration statement as of the time it was declared effective.

(2)          For purposes of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Diego, State of California, on June 25, 2014.

 

PFENEX INC.
By:   /s/ Bertrand C. Liang
 

Bertrand C. Liang

President, Chief Executive Officer and Director

Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration Statement has been signed below by the following persons in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

/s/ Bertrand C. Liang

Bertrand C. Liang

  

Chief Executive Officer and Director

(principal executive officer)

 

June 25, 2014

/s/ Paul A. Wagner

Paul A. Wagner

  

Chief Financial Officer

(principal financial officer)

  June 25, 2014

*

Patricia Lady

  

Chief Accounting Officer

(principal accounting officer)

  June 25, 2014

*

James C. Gale

  

Chairman of the Board

  June 25, 2014

*

Kenneth Van Heel

  

Director

  June 25, 2014
*By:   /s/    Bertrand C. Liang
 

Bertrand C. Liang

Attorney-in-fact

 

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EXHIBIT INDEX

 

Exhibit
Number
 

Description of Exhibit

  1.1*   Form of Underwriting Agreement, including form of lock-up agreement.
  3.1^   Amended and Restated Certificate of Incorporation, as amended, as in effect prior to the completion of the offering.
  3.2^   Form of Amended and Restated Certificate of Incorporation, to be effective upon completion of the offering.
  3.3^   Form of Amended and Restated Bylaws, to be effective upon completion of the offering.
  4.1^   Specimen Stock Certificate.
  4.2^   Investors’ Rights Agreement, dated December 1, 2009, by and among the Registrant and the investors named therein.
  4.3^   Amended and Restated Subscription Agreement, dated May 2, 2014.
  5.1*   Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation.
10.1+^   2009 Equity Incentive Plan and form of award thereunder.
10.2*+   2014 Equity Incentive Plan, to be in effect upon completion of this offering and form of award thereunder.
10.3+^   2014 Employee Stock Purchase Plan, to be in effect upon completion of this offering.
10.4^   Form of Indemnification Agreement.
10.5^   Lease Agreement, dated June 22, 2010, between the Registrant and BRS-TUS7TN SAFEGUARD ASSOCIATES II, LLC.
10.6†   Joint Development & License Agreement, dated December 31, 2012, between the Registrant and Agila Biotech Private Limited.
10.7†   Joint Venture Agreement, dated March 7, 2013, between the Registrant and Agila Biotech Private Limited.
10.8†   Technology License Agreement, dated November 30, 2009, between the Registrant and The Dow Chemical Company.
10.9^   Grant Back License Agreement, dated November 30, 2009, between the Registrant and The Dow Chemical Company.
10.10^   Technology Assignment Agreement, dated November 30, 2009, between the Registrant and The Dow Chemical Company.
10.11^   Contribution Assignment and Assumption Agreement, dated November 30, 2009, between the Registrant and The Dow Chemical Company.
10.12†   Subcontract Agreement, effective September 11, 2009, between the Registrant, as assignee of the Dow Chemical Company, and Science Applications International Corporation.
10.13†   Cost Plus Fixed Fee Agreement, dated July 30, 2010, between the Registrant and the United States Department of Health and Human Services.
10.14^   Credit Agreement, dated May 1, 2012, between the Registrant and Wells Fargo Bank, National Association.
10.15^   Security Agreement, dated May 1, 2012, between the Registrant and Wells Fargo Bank, National Association.
10.16^   Revolving Line of Credit Note, dated May 1, 2012, between the Registrant and Wells Fargo Bank, National Association.
10.17^   Security Agreement, dated June 24, 2013, between the Registrant and Wells Fargo Bank, National Association.
10.18^   Revolving Line of Credit Note, dated June 24, 2013, between the Registrant and Wells Fargo Bank, National Association.
10.19^   Securities Account Control Agreement, dated June 24, 2013, between the Registrant and Wells Fargo Bank, National Association.
10.20+^   Executive Employment Agreement, dated June 20, 2014, between the Registrant and Bertrand C. Liang.


Exhibit
Number
  

Description of Exhibit

10.21+^    Executive Employment Agreement, dated June 20, 2014, between the Registrant and Paul A. Wagner.
10.22+^    Executive Employment Agreement, dated June 20, 2014, between the Registrant and Patricia Lady.
10.23+^    Executive Employment Agreement, dated June 20, 2014, between the Registrant and Patrick K. Lucy.
10.24+^    Executive Employment Agreement, dated June 20, 2014, between the Registrant and Henry W. Talbot.
10.25†   

Contract Agreement, dated September 27, 2012, between the Registrant and the National Institutes of Health.

10.26+^    Offer Letter, dated December 10, 2009, as amended, between the Registrant and Charles Squires.
10.27+^    Executive Incentive Compensation Plan.
21.1^    List of Subsidiaries of Pfenex Inc.
23.1^    Consent of Haskell & White LLP.
23.2*    Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation (included in Exhibit 5.1).
24.1^    Power of Attorney
99.1^    Director Designee Consent of William Rohn.
99.2^    Director Designee Consent of Phillip Schneider.

 

^ Previously filed.
* To be filed by amendment.
+ Indicates a management contract or compensatory plan.
Portions of this exhibit have been omitted pending a determination by the Securities and Exchange Commission as to whether these portions should be granted confidential treatment.

Exhibit 10.6

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].”

CONFIDENTIAL

EXECUTION COPY

JOINT DEVELOPMENT & LICENSE AGREEMENT

This Joint Development and License Agreement (this “ Agreement ”) is made as of the 31 st day of December 2012 (the “ Effective Date ”), by and between Pfenex, Inc., a Delaware corporation with a principal place of business located at 10790 Roselle Street, San Diego, CA 92121 (“ Pfenex ”), and Agila Biotech Private Limited, company incorporated under the Companies Act, 1956 and having its registered office at Strides House, Bilekahalli, Bannerghatta Road, Bangalore 560 076, India (“ Agila ”). Pfenex and Agila may be referred to individually as a “ Party ” or together as the “ Parties .”

BACKGROUND

A. Pfenex has a proprietary Pseudomonas fluorescens protein expression platform (as further defined below as the “ Pfenex Expression Technology ”), which is used to increase yield, accelerate the development and production of biotherapeutics and vaccines;

B. Agila is engaged in the business of manufacturing and supplying therapeutic biological products for research and development and commercial purposes;

C. Pfenex and Agila desire to collaborate with each other, to develop certain therapeutic biological products manufactured using the Pfenex Expression Technology through the completion of the first Phase I Clinical Trial (as defined below) for each such product in accordance with the terms and conditions of this Agreement;

D. Pfenex and Agila wish to establish a joint venture company (the “ JVC ”) to further develop and commercialize one or more such products after the completion of the first Phase I Clinical Trial pursuant to a separate Joint Venture Agreement to be entered into by the Parties (the “ JVA ”) as set forth in Section 3.8; and

E. Upon successful completion of the first Phase I Clinical Trial in the Territory for such a product and the JVC’s receipt of all necessary Consents, business licenses and governmental approvals, and contingent upon the Parties’ agreement on a plan and budget for the further development and commercialization of such product, such product and all associated data, rights and assets will be transferred to the JVC and the JVC will continue the development and commercialization of such product as further provided in the JVA.

NOW, THEREFORE, in consideration of the mutual covenants and promises herein contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the Parties, the Parties agree as follows:

Article 1

DEFINITIONS

1.1 “ Act ” means the Drugs and Cosmetics Act, 1940.

1.2 “ Affiliate ” means, with respect to a Party, any Person controlling, controlled by or under common control with such Party, for so long as such control exists. For

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


the purposes of this definition, “control” means: (a) to possess, directly or indirectly, the power to direct the management and policies of such Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) ownership of more than fifty percent (50%) of the voting securities in such Person (or such lesser percent as may be the maximum that may be owned pursuant to Applicable Laws of the country of incorporation or domicile, as applicable). For clarity, for purposes of this Agreement, the JVC shall not be deemed an Affiliate of either Party.

1.3 “ Analytical Methods ” means, with respect to a Collaboration Product, a comprehensive set of analytical methods used to test the quality of in-process, bulk drug substance(s) and drug product(s) for the applicable Collaboration Product.

1.4 “ Applicable Laws ” means any laws, statutes, rules, regulations, guidelines, and standards promulgated by any governmental authority of competent jurisdiction applicable to the Parties or the activities contemplated hereunder, together with any judgments, orders, notices, instructions, decisions, standards, guidance and awards, each having the force of law, issued by a court or competent authority or tribunal or a Regulatory Authority to which the applicable Party is subject, including, as applicable, GCP, GLP, GMP, the Act and the Rules.

1.5 “ Background Technology ” means, with respect to a Party, any and all technology, know-how, technical information and other technical subject matter, and all intellectual property rights therein, in each case Controlled by such Party as of the Effective Date or otherwise developed or acquired by or on behalf of such Party outside the performance of this Agreement, in each case that are necessary for the performance of any Development Plan under this Agreement. For clarity, Pfenex’s Background Technology includes the Pfenex Expression Technology, including to the extent it is embodied in the Pfenex Materials and Deliverables.

1.6 “ Collaboration Product(s) ” means, individually and collectively, any product for which the Parties establish and sign a Development Plan pursuant to Section 3.1 for development hereunder, which may include but not limited to:

(a) Interferon beta-1b as a biosimilar product to the innovator product Betaseron®/Betaferon® from Bayer HealthCare Pharmaceuticals;

(b) PEGylated Interferon beta-1b;

(c) PEGylated Granulocyte Colony-Stimulating Factor (PEG-GCSF) as a biosimilar product to the innovator product Neulasta® from Amgen Inc.;

(d) PEGylated L-Asparaginase as a biosimilar product to Oncaspar® from Sigma-Tau Pharmaceuticals Inc.; and

(e) Human Growth Hormone (HGH) as a biosimilar product to Genotropin® from Pfizer Inc.

1.7 “ Consents ” means any consent, license, approval, authorization, waiver, permit, grant, concession, agreement, license, certificate, exemption, order or registration, of or with any Person.

 

[*] Certain information in this document 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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1.8 “ Control ” means the possession (whether by ownership, license or other authorization), as of the Effective Date or during the Term, of (a) with respect to materials, data or information, physical possession or the right to such physical possession of those items, and the right to provide them to others (including the other Party); and (b) with respect to intellectual property rights, the right sufficient to grant the applicable license or sublicense under this Agreement; in each case without violating the terms of any agreement with any Third Party. Notwithstanding anything to the contrary in this Agreement, the following shall not be deemed to be Controlled by a Party: (i) any materials, data, information or intellectual property owned or licensed by any Acquiring Entity immediately prior to the effective date of merger, consolidation or transfer, and (ii) any materials, data, information or intellectual property that any Acquiring Entity subsequently develops independently, without accessing or practicing the Pfenex Background Technology (in the case of an Acquiring Entity of Pfenex) or the Agila Background Technology (in the case of an Acquiring Entity of Agila). For the purpose of this Section 1.8, “ Acquiring Entity ” means, with respect to a Party, a Third Party that merges or consolidates with or acquires such Party, or to which such Party transfers all or substantially all of its assets to which this Agreement pertains. “ Controlled ” has its corollary meaning.

1.9 “ Facility ” means (a) each GMP-compliant facility jointly identified by both Parties for manufacturing (including storing and handling) any Collaboration Product for Phase I Clinical Trials, (b) Agila’s GMP-compliant Pilot Plant located at [*] and (c) Agila’s GMP-compliant manufacturing facility under construction at the [*] (the “ [*] Facility ”), only when all applicable testing and validation of such facility has been successfully completed, and all required Consents have been obtained, and such facility is otherwise ready and available for use in manufacture of Collaboration Products.

1.10 “ GCP ” means the then-current FDA regulations and guidelines for “Good Clinical Practice,” as promulgated by the FDA under 21 CFR Parts 50, 54, 56 and 312, as amended from time to time, or any foreign equivalents thereto (e.g., ICH Guideline for Good Clinical Practice) in the country in which the applicable Phase I Clinical Trial is conducted.

1.11 “ GMP ” means the then-current Good Manufacturing Practices pursuant to the U.S. Food, Drug and Cosmetic Act and any U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations (including Parts 11, 210 and 211 and the provisions of the Act and the Rules) and comparable laws, rules and regulations applicable to the manufacture, labeling, packaging, handling, storage, supply and transport of any Collaboration Product in any jurisdiction where the applicable Collaboration Product is or may be utilized in humans hereunder.

1.12 “ GLP ” means the then-current FDA regulations and guidelines for “Good Laboratory Practice,” as promulgated by the FDA under Title 21 of the U.S. Code of Federal Regulations Part 58, as amended from time to time, or any foreign equivalents thereto in the country in which research is conducted hereunder.

1.13 “ Manufacturing Process ” means, with respect to a Collaboration Product, the process based on the Pfenex Expression Technology for the production of such Collaboration Product using the associated Manufacturing Strain, as such process may be amended from time to time by the Parties pursuant to Section 5.2 below.

 

[*] Certain information in this document 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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1.14 “ Manufacturing Strain ” means, with respect to a Collaboration Product, a strain of Pseudomonas fluorescens incorporating a nucleic acid sequence that is optimized to express the protein that is the active ingredient of such Collaboration Product.

1.15 “ Master Cell Bank ” means a cell bank produced from the Research Cell Bank for a Collaboration Product that complies with (a) GMP requirements for cell banks used in the production of biological products for use in humans and (b) the specifications therefor as set forth in the Development Plan for such Collaboration Product, a portion of which is anticipated to be deposited with a Third Party vendor for storage and preservation and which cell bank may be used in the establishment of the Working Cell Bank for such Collaboration Product.

1.16 “ PEGylation ” means the process of covalent attachment of polyethylene glycol (PEG) polymer chains to another molecule. “ PEGylated ” shall have its correlative meanings.

1.17 “ Person ” means any individual, corporation, partnership, limited liability company, trust, business trust, association, joint-stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, government authority or any other form of entity not specifically listed herein.

1.18 “ Pfenex Expression Technology ” means Pfenex’ proprietary Pseudomonas fluorescens expression platform technology used in the development and production of biological products, including through the optimization of a nucleic acid sequence and development of the associated manufacturing cell strains to express such product, together with all intellectual property rights therein.

1.19 “ Phase I Clinical Trial ” means a clinical development program that provides for the first introduction into humans of a pharmaceutical product with the primary purpose of making a preliminary determination with respect to safety, metabolism and pharmacokinetic properties and clinical pharmacology of such pharmaceutical product in healthy patients, or otherwise generally consistent with 21 C.F.R. §312.21(a).

1.20 “ Phase III Clinical Trial ” means any human clinical trial conducted in any country on a sufficient numbers of patients that is designed, if the defined end-points are met, to establish safety and efficacy of a pharmaceutical product in patients with the indication being studied for purposes of filing a marketing approval application or to otherwise be a pivotal trial for obtaining a marketing approval or label expansion for such pharmaceutical product or otherwise generally consistent with 21 C.F.R. §312.21(c).

1.21 “ Raw Materials ” means, with respect to any Collaboration Product(s), any and all ingredients, including media, buffers, solvents and other components (excluding the Manufacturing Strain as provided under Section 4.1.1 below) used in the manufacture of such Collaboration Product hereunder in accordance with the Manufacturing Process and Specifications for such Collaboration Product.

 

[*] Certain information in this document 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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1.22 “ Regulatory Approval ” means all approvals, licenses, clearances, registrations or authorizations received from any Regulatory Authority in response to a Regulatory Filing together with all necessary approvals by any regulatory advisory board (e.g. institutional review board and ethics committee).

1.23 “ Regulatory Authority ” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the development, manufacture or other commercialization (including the granting of Regulatory Approvals) of any Collaboration Product in any jurisdiction, including the Drugs Controller General of India, European Medicines Agency and the United States Food and Drug Administration (“ FDA ”), in each case, any successor entity thereto.

1.24 “ Regulatory Filings ” means any submission made to a Regulatory Authority with respect to a pharmaceutical or medicinal product, including any application necessary to commence or conduct clinical testing of such product in humans, any submission to a regulatory advisory board with respect to such product, and in each case any supplement or amendment to any of the foregoing.

1.25 “ Research Cell Bank ” means a non GMP cell bank of the Manufacturing Strain for a Collaboration Product meeting the specifications therefor as set forth in the Development Plan for such Collaboration Product.

1.26 “ Rules ” means the Drugs and Cosmetic Rules, 1945.

1.27 “ Study Results ” means any and all data, results and reports from any preclinical or clinical studies with respect to any Collaboration Product conducted hereunder, including all data, results and reports from each Phase I Clinical Trial conducted hereunder and all interim reports and the final report generated therefrom.

1.28 “ Specifications ” means, with respect to a Collaboration Product, those specifications, manufacturing guidelines, control procedures, acceptance criteria, validation protocols, packaging, storage and release requirement or procedures or other similar requirements for the manufacture of such Collaboration Product, as mutually agreed by the Parties and set forth in the applicable Development Plan.

1.29 “ Successful Completion ” means, with respect to a Phase I Clinical Trial, the meeting of primary endpoints set forth in the applicable protocol approved by the JSC and the submission of the final trial report to the applicable Regulatory Authority as required under Applicable Law.

1.30 “ Territory ” means worldwide.

1.31 “ Third Party ” means an entity other than Pfenex, Agila and their respective Affiliates.

1.32 “ Working Cell Bank ” means a cell bank of the Manufacturing Strain produced from the Master Cell Bank for a Collaboration Product that complies with (a) GMP requirements for cell banks used in the production of biological products for use in humans and (b) the specifications therefor as set forth in the Development Plan for such Collaboration Product.

 

[*] Certain information in this document 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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1.33 Additional Defined Terms . Each of the following terms shall have the meaning described in the corresponding section of this Agreement indicated below:

 

Term    Section Defined
Agila Improvements    10.5
Alliance Manager    2.6
Co-Chair    2.2
Collaboration Technology    10.3
Confidential Information    9.1
Development Plan    3.1
Indemnitee    13.3
Indemnitor    13.3
JSC    2.1
JVA    Background
JVC    Background
Milestone    8.1
Pfenex Improvements    10.4
Pfenex Materials and Deliverables    4.1.1
Plan and Budget    3.9
Prior Confidentiality Agreement    9.5
SIAC    14.9.2
Subcommittee    2.7
Term    11.1

1.34 Interpretation . The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits means the particular Articles and Sections of or Exhibits to this Agreement, and references to this Agreement include all Exhibits hereto. Unless context clearly requires otherwise, whenever used in this Agreement: (a) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation;” (b) the word “or” shall have its inclusive meaning of “and/or;” (c) the word “day” or “quarter” or “year” means a calendar day or calendar quarter or calendar year unless otherwise specified; (d) the word “notice” shall require notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (e) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits); (f) provisions that require that a Party or the Parties hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise; (g) words of any gender include the other gender; (h) words using the singular or plural number also include the plural or singular number, respectively; (i) references to any specific law, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement thereof; and (j) provisions that refer to Persons acting “under the authority of Pfenex” shall include Pfenex’s Affiliates or licensees, as

 

[*] Certain information in this document 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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applicable, and those Persons acting “under the authority of Agila” shall include Agila’s Affiliates or sublicensees, as applicable; conversely, those Persons acting “under the authority of Pfenex” shall exclude Agila, its Affiliates and sublicensees, as applicable, and those Persons acting “under the authority of Agila” shall exclude Pfenex, its Affiliates and licensees, as applicable.

Article 2

GOVERNANCE

2.1 JSC Establishment . Within thirty (30) days of the Effective Date, the Parties agree to establish a joint steering committee (“ JSC ”) for the overall coordination and oversight of the Parties’ activities under this Agreement.

2.2 JSC Membership . The JSC shall be comprised of an equal number of representatives from each of Pfenex and Agila, with at least two (2) representatives from each Party. Either Party may replace its respective JSC representatives at any time with prior written notice to the other Party, provided that such replacement has comparable authority and scope of functional responsibility within that Party’s organization as the individual he or she is replacing. Without limiting the foregoing, each Party shall appoint by notice to the other Party one of its members to the JSC as a co-chair of the JSC (each, a “ Co-Chair ”). The Co-Chairs shall (a) coordinate and prepare the agenda and ensure the orderly conduct of the JSC’s meetings, (b) attend (subject to below) each meeting of the JSC, and (c) prepare and issue minutes of each meeting within ten (10) business days thereafter accurately reflecting the discussions and decisions of the JSC at such meeting. Such minutes from each JSC meeting shall not be finalized until a member from each Party has reviewed and approved the accuracy of such minutes in writing. The Co-Chairs shall solicit agenda items from the other JSC members and provide an agenda along with appropriate information for such agenda reasonably in advance (to the extent possible) of any meeting. In the event the presiding Co-Chair or another member of the JSC from either Party is unable to attend or participate in any meeting of the JSC, the Party who designated such member may designate a substitute representative for the meeting.

2.3 JSC Responsibilities . The role of the JSC shall be:

2.3.1 to review and approve the Development Plan for any Collaboration Product(s) and any amendment thereto;

2.3.2 to coordinate and oversee the transfer of Pfenex Materials and Deliverables to Agila;

2.3.3 to manage and oversee the implementation of the Development Plan for any Collaboration Product(s), including all regulatory activities required or otherwise conducted in accordance therewith;

2.3.4 to monitor each Phase I Clinical Trial conducted pursuant to the Development Plan for the respective Collaboration Product(s);

 

[*] Certain information in this document 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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2.3.5 to provide a forum for the Parties to exchange information with respect to matters pertaining to and status of the performance of the Development Plan for any Collaboration Product(s);

2.3.6 to coordinate and oversee the transfer of any Collaboration Product(s) to the JVC pursuant to Section 3.9; and

2.3.7 to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth hereunder or otherwise agreed in writing by the Parties.

2.4 JSC Meetings .

2.4.1 Conduct . During the Term, the JSC shall hold at least one (1) meeting per calendar quarter in accordance with a schedule established in advance annually or as the JSC otherwise agrees. Meetings of the JSC shall be effective only if at least one (1) representative of each Party is present or participating. The JSC may meet either (a) in person at either Party’s facilities or at such locations as the Parties may otherwise agree; or (b) by audio or video teleconference; provided that at least one (1) such meeting per year shall be in person. With the prior consent of the other Party’s representatives (such consent not to be unreasonably withheld or delayed), each Party may invite non-member employees to participate in the discussions and meetings of the JSC, provided that such participants shall have no vote and shall be subject to the confidentiality provisions set forth in Article 9 of this Agreement. Additional meetings of the JSC may also be held with the mutual consent of the Parties, or as required under this Agreement, and neither Party will unreasonably withhold or delay its consent to hold any such additional meeting. Each Party shall be responsible for all of its own expenses incurred in connection with participating in the JSC.

2.4.2 Progress Report . At each meeting of the JSC, each Party shall summarize to the JSC the progress of the activities performed by or under authority of such Party and its Affiliates with respect to each Collaboration Product during the period since the last meeting of the JSC.

2.5 JSC Decision Making . Decisions of the JSC shall be made by consensus, with each Party having one (1) vote. Each Party shall act in good faith to reach consensus on all matters and act in the general spirit of cooperation and in no event shall either Party unreasonably withhold, condition or delay any approval or other decision of the JSC hereunder. In the event the JSC fails to reach consensus with respect to a particular matter within its authority, then upon request by either Party such matter shall be resolved pursuant to Section 14.10. For clarity, the JSC shall not have the power to amend or modify this Agreement, and no decision of the JSC shall be in contravention of any terms or conditions of this Agreement. It is understood and agreed that issues to be formally decided by the JSC are only those specific issues that are expressly provided in this Agreement or otherwise mutually agreed by the Parties to be decided by the JSC.

2.6 Alliance Manager . Promptly after the execution of this Agreement each Party shall appoint a single individual to act as the primary point of contact between the Parties

 

[*] Certain information in this document 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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in connection with the performance of the Development Plans (each, an “ Alliance Manager ”). Each Party may at any time appoint a different Alliance Manager by written notice to the other Party and may elect, upon mutual agreement by the Parties, to eliminate the responsibilities of the Alliance Managers. The Alliance Managers shall be entitled to attend meetings of the JSC, but shall not have, or be deemed to have, any rights or responsibilities of a member of the JSC. Each Alliance Manager may bring any matter to the attention of the JSC where such Alliance Manager reasonably believes that such matter requires such attention.

2.7 Subcommittees . Promptly after the establishment of the JSC, the JSC shall establish the following subcommittees (each, a “ Subcommittee ”): (a) a preclinical, clinical and regulatory Subcommittee to coordinate and make all day-to-day decisions necessary to implement any preclinical or clinical studies and regulatory activities set forth in each Development Plan; (b) a chemistry, manufacturing, and controls (CMC) Subcommittee to coordinate and make all day-to-day decisions necessary to implement any manufacturing-related activities set forth in each Development Plan; (c) a commercialization Subcommittee to (i) propose business/ commercialization strategies and priorities with respect to the Collaboration Products for the review and approval of the JSC and (ii) coordinate and resolve any issue arising from the performance of each Development Plan that may impact such business/commercialization strategy for any Collaboration Product; (d) an intellectual property Subcommittee to develop and implement the intellectual property strategy with respect to Collaboration Technology and coordinate the prosecution and maintenance of patents and patent applications claiming any jointly owned Collaboration Technology; and (e) a Subcommittee to oversee and coordinate the transfer of various technologies as contemplated herein, whether between the Parties or to a Third Party. Each Subcommittee shall consist of equal number of representatives of each Party and shall meet with such frequency as the JSC determines is appropriate. Each Subcommittee shall be responsible for day-to-day implementation and operations of the activities under this Agreement for which it has or is otherwise assigned responsibility, provided that such implementation is not inconsistent with the express terms of this Agreement, the applicable Development Plan or the decisions of the JSC. Each Subcommittee shall operate by unanimous vote in all decisions, with each Party having one (1) vote and with at least one (1) representative from each Party participating in such vote. If, with respect to a matter that is subject to a Subcommittee’s decision-making authority, the Subcommittee cannot reach unanimity, the matter shall be referred to the Alliance Manager, who shall submit such matter to the JSC for resolution in accordance with Section 2.5. The various Subcommittees may have overlapping membership and the Parties will attempt to time meetings of the JSC and the various Subcommittees to maximize productivity of the members and minimize costs associated therewith.

Article 3

PRODUCT DEVELOPMENT

3.1 Development Plan . Promptly after the execution of this Agreement, on a Collaboration Product-by-Collaboration Product basis, Pfenex and Agila shall jointly prepare a mutually-agreed written work plan for any Collaboration Product(s) that sets out in reasonable detail the development activities to be conducted by each Party and its designees for the Successful Completion of the first Phase I Clinical Trial for any Collaboration Product(s), as well as the location, protocol, budget and timelines for completion of various tasks therefor

 

[*] Certain information in this document 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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(each, a “ Development Plan ”). Each Development Plan shall be subject to the JSC’s approval. Upon the JSC’s approval of a Development Plan, such Development Plan shall be signed by a duly authorized representative from each Party and attached hereto as a part of this Agreement. For the avoidance of doubt, unless and until the Parties sign the Development Plan for any Collaboration Product, neither Party shall have any obligation with respect to any product hereunder; provided, however, that unless and until the earlier of (a) the Parties sign a Development Plan therefor or (b) either Party provides sixty (60) days’ prior written notice to the other Party of its intent to exclude a product described in Section 1.6(a) — (e), the Parties shall use good faith efforts to prepare and agree on Development Plan therefor prior to the date specified in Exhibit 1 (as may be amended from time to time by the Parties). Each Development Plan will be updated and approved semi-annually by the JSC and shall be consistent with the general allocation of responsibilities described in Section 3.2 below. Without limiting the foregoing, any material modifications or additions to any Development Plan (including any proposed change(s) to any Third Party designee) shall be first approved by JSC prior to its implementation. Each Party shall perform its obligations allocated to it under each Development Plan in accordance with the terms and conditions of this Agreement (including the diligence requirement set forth in Article 8), the applicable Development Plan and all Applicable Laws.

3.2 General Allocation of Responsibilities .

3.2.1 To Pfenex . As further provided in the applicable Development Plan, with respect to each Collaboration Product, Pfenex shall be responsible for and shall bear the expenses of:

(a) establishing and characterizing a Research Cell Bank for such Collaboration Product (and in the case of the Interferon beta-1b Collaboration Product only, an initial Master Cell Bank and Working Cell Bank);

(b) developing Manufacturing Process and Analytical Methods for such Collaboration Product;

(c) transferring the Research Cell Bank, Manufacturing Process and Analytical Methods for such Collaboration Product to Agila along with copies of existing documentation associated therewith;

(d) providing technical assistance to Agila with respect to Agila’s use thereof in accordance with and during the Term; and

(e) providing assistance to Agila to apply for any funding/grants from any national (Indian), international or other sources for the development of such Collaboration Product.

3.2.2 To Agila . As further provided in the applicable Development Plan, with respect to each Collaboration Product, Agila shall be responsible for and shall bear the expenses of:

(a) establishing and characterizing a Master Cell Bank and Working Cell Bank for the production of such Collaboration Product (except in the case of the Interferon beta-1b Collaboration Product only, for which Pfenex will be responsible for establishing and characterizing the initial Master Cell Bank and Working Cell Bank);

 

[*] Certain information in this document 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) transferring a portion of the Master Cell Bank to a mutually agreed Third Party for storage and preservation;

(c) performing any necessary formulation development for such Collaboration Product;

(d) performing any necessary scale up and validation activities and implementing the GMP manufacturing of such Collaboration Product;

(e) performing the proper stability studies and analytical, process and shipping validation for such Collaboration Product in accordance with GMP;

(f) developing and performing any necessary PEGylation process for such Collaboration Product;

(g) obtaining and maintaining appropriate Consents including facility permits, manufacturing licenses, manufacturing and analytical records and approvals necessary for the manufacture of such Collaboration Product;

(h) performing any necessary GLP toxicology study for such Collaboration Product and provide sufficient amount of such Collaboration Product for other preclinical studies and the first Phase I Clinical Trial;

(i) managing regulatory matters (including making all Regulatory Filings with Regulatory Authorities for obtaining all necessary Regulatory Approvals to initiate the first Phase I Clinical Trial for such Collaboration Product); and

(j) conducting the first Phase I Clinical Trial for such Collaboration Product and undertake other actions necessary for the Successful Completion of such Phase I Clinical Trial; and

(k) applying for funding/grants from any national (Indian), international or other sources for the development of such Collaboration Product, with the assistance of Pfenex.

3.3 Development Costs . As between the Parties, each Party shall bear all of the costs and expenses incurred in connection with any of the activities allocated to such Party under this Agreement and each applicable Development Plan. Notwithstanding anything to the contrary in this Agreement or any Development Plan, Agila shall be responsible for all costs and expenses incurred by the Parties in conducting the first Phase I Clinical Trial of any Collaboration Product hereunder. Notwithstanding the foregoing, neither Party may commit to, enter into any agreement for the conduct of a Phase I Clinical Trial or manufacturing agreement under the Development Plan(s) for any Collaboration Product(s) except as approved by the JSC; provided, however, Agila will reimburse Pfenex for those costs incurred in connection for the Phase I Clinical Trial for the Interferon beta-1b Collaboration Product (including the GMP manufacture of such Collaboration Product therefor) as set forth on Exhibit 2 .

 

[*] Certain information in this document 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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3.4 Subcontractors . Except as set forth in the applicable Development Plan, neither Party may subcontract or otherwise delegate all or any portion of its obligations under this Agreement (including substituting or adding manufacturing or contract research facilities of a Third Party) without JSC’s prior written approval. When considering a subcontractor a Party will advise the JSC, which will establish an audit team comprised of members from each Party to audit or review such subcontractor to ensure that the subcontractor meets the qualifications necessary and has complied with Applicable Laws with respect to the subcontracting activities for which such subcontractor is being considered. To the extent such approval is granted, the subcontracting Party shall (a) ensure that each such subcontractor has and maintains all appropriate qualifications and complies with Applicable Laws and that the other Party or its designee has the right to participate in and approve such qualification process; (b) ensure that all such approved subcontractors comply with the provisions of this Agreement; and (c) be responsible for each such subcontractor’s performance hereunder (including, without limitation, any breach of this Agreement by such subcontractor), as if such subcontracting Party were itself performing such activities. For clarity, each Party may exercise its rights or perform its obligations under this Agreement through one or more of its Affiliates; provided that each Party shall ensure that each such Affiliate complies with the provisions of this Agreement and be responsible for each such Affiliate’s performance hereunder (including, without limitation, any breach of this Agreement).

3.5 Protocols . All protocols for any pre-clinical or clinical studies to be performed with respect to each Collaboration Product shall be developed by the relevant Subcommittee, in consultation with those relevant scientific/technical representatives from each Party, and submitted to the JSC for its review and approval. Further, any material modification to any such protocol shall subject to the review and approval of the JSC. For the avoidance of doubt, all study sites and investigators for each Phase I Clinical Trial of any Collaboration Product conducted under this Agreement shall be included in the applicable Development Plan and subject to the review and approval of the JSC.

3.6 Information Sharing . On an annual basis or as the JSC otherwise determines during the Term, and without limiting Section 2.4.2, each Party shall provide to the other Party the documentation, reports and other data from or relating to any completed or ongoing development activities and the results thereof (and summaries of any results in English if such documentation and materials are not provided in English) controlled by such Party relating to each Collaboration Product (including documentation relating to Regulatory Filings and Regulatory Approvals, original source data, reports, case report forms (CRFs) and summary literature). Each Party shall have the right to use, and disclose (provided that if such information is the Confidential Information of the other Party, such disclosure shall be subject to confidentiality obligations as set forth in Article 9 of this Agreement) such information to the extent necessary to exercise its rights and fulfill its obligations hereunder.

3.7 Exclusivity of Efforts . On a Collaboration Product-by-Collaboration Product basis, during the Term for the applicable Collaboration Product, each Party agrees that, except for its obligations hereunder, neither it nor any of its Affiliates shall develop,

 

[*] Certain information in this document 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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manufacture, supply or commercialize any Collaboration Product, or assist any Third Party to perform any such activities with respect to any Collaboration Product. In addition, neither Party shall, during or after the Term, use any Study Results other than pursuant to this Agreement or the JVA. Notwithstanding the foregoing, nothing herein is intended to require a Party to breach those obligations set forth in Exhibit 3 under such Party’s name.

3.8 Execution of the JVA . As soon as practicable after the execution of this Agreement, the Parties shall finalize and execute the JVA by no later than February 28, 2013. It is understood that the JVA will be in the form under negotiations by the Parties as of the Effective Date, except that the Parties may (i) change the jurisdiction of incorporation of the JVC as mutually agreed by the Parties, (ii) make other changes to the extent necessary or appropriate to comply with applicable laws of the jurisdiction of incorporation of the JVC, and (ii) modify those tax-related provisions for the purpose of minimizing each Party’s tax liabilities arising from its activities under the JVA to the extent legally permissible.

3.9 Collaboration Product Transfer to the JVC . On a Collaboration Product-by-Collaboration Product basis, reasonably in advance of the anticipated completion of the first Phase I Clinical Trial for a Collaboration Product, the Parties shall, through the JSC, discuss and develop a detailed development plan and budget setting forth in reasonable detail the activities to be conducted by the JVC for the further development and commercialization of such Collaboration Product and associated budget and timelines, including the strategy for conducting Phase III Clinical Trials for such Collaboration Product, the location for such trials, the contract research organizations to conduct such trials and the budget therefor, as well as the launch strategy for such Collaboration Product and budget therefor (each, a “ Plan and Budget ”). Upon Successful Completion of the first Phase I Clinical Trial in the Territory for a Collaboration Product and the JVC’s receipt of all necessary Consents, business licenses, permits and Regulatory Approvals, and further contingent upon the Parties’ agreement on the applicable Plan and Budget and the JVC board of director’s ratification thereof, such Collaboration Product will be transferred to the JVC, and the JVC will continue the development and commercialization of such Collaboration Product in accordance with the applicable Plan and Budget as further provided in the JVA. The Parties shall conduct no further development activities with respect to a Collaboration Product under this Agreement after such Collaboration Product is transferred to the JVC.

Article 4

PFENEX DELIVERABLES

4.1 Delivery of Manufacturing Strain; Restrictions .

4.1.1 Delivery . With respect to each Collaboration Product, promptly after Pfenex has established (a) Research Cell Bank, (b) Manufacturing Process and (c) Analytical Methods for such Collaboration Product, Pfenex shall deliver to Agila the Manufacturing Process and the associated Research Cell Bank, Analytical Methods for the production of such Collaboration Product (all such deliverables (including in the case of the Interferon beta-1b Collaboration Product only, an initial Master Cell Bank and Working Cell Bank) together with all modifications or derivatives thereof based in whole or part from the Pfenex Expression Technology, collectively referred to as the “ Pfenex Materials and

 

[*] Certain information in this document 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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Deliverables ”). Pfenex Materials and Deliverables shall be and remain the sole and exclusive property of Pfenex and the physical possession of such Pfenex Materials and Deliverables by Agila shall not be (nor be construed as) a sale, lease, offer to sell or lease, or other transfer of title of such materials to Agila. Except as expressly provided in this Agreement, no licenses or rights shall be deemed granted to Agila, by implication, estoppel or otherwise, by the transfer of physical possession of any such Pfenex Materials and Deliverables to Agila.

4.1.2 Limitations on Use and Transfer . Agila shall not use the Pfenex Materials and Deliverables for any purpose other than for the performance of its obligations under this Agreement. Except as otherwise authorized by Pfenex in writing, Agila shall not provide the Pfenex Materials and Deliverables to any Person other than to approved subcontractors in furtherance of Section 3.4 or those employees of Agila who require access to the Pfenex Materials and Deliverables, in each case for the performance of the activities allocated to Agila under any Development Plan. Agila shall only use the Pfenex Materials and Deliverables in compliance with all Applicable Laws.

4.1.3 No Modification or Derivation . Except as (a) expressly set forth in the applicable Development Plan or (b) allowed with Pfenex’s prior written consent, Agila shall not attempt to alter or modify the Pfenex Materials and Deliverables in any way, or to make any derivatives or modifications thereof and shall not under any circumstances attempt, directly or indirectly, to analyze, characterize, reverse engineer or otherwise derive the sequences, or constructs of the Pfenex Materials and Deliverables. It is understood that from time to time with Pfenex’s prior consent, Agila may modify the Pfenex Materials and Deliverables so as to improve the performance thereof.

4.1.4 Care in Use of the Pfenex Materials and Deliverables . Agila acknowledges that the Pfenex Materials and Deliverables are experimental in nature and may have unknown characteristics and therefore agrees to use prudence and all reasonable care in the use, handling, storage, containment, transportation and disposition of the Pfenex Materials and Deliverables.

4.2 Warranties Regarding Pfenex Materials and Deliverables . Pfenex hereby represents and warrants to Agila that (a) Pfenex owns or has rights to the Pfenex Materials and Deliverables; (b) Pfenex has the right to provide the Pfenex Materials and Deliverables to Agila for use in accordance with this Agreement and (c) the Pfenex Materials and Deliverables meet the written specifications therefor as set forth in the applicable Development Plan(s) at the time of delivery to Agila.

4.3 Acknowledgement . Agila acknowledges that the use or modification of the Pfenex Materials and Deliverables other than as permitted under this Agreement could cause irreparable damage to Pfenex. As such, Agila agrees that: (a) any breach of this Article 4 shall be considered a material breach of this Agreement; (b) Pfenex shall have the right to receive an assignment of all right, title and interest in and to any patent or patent application that contains, discloses or claims any invention arising from an impermissible modification or use of the Pfenex Materials and Deliverables, and (c) the remedies set forth in subsections (a) and (b) shall not prejudice Pfenex’s right to pursue any legal or equitable remedy available to Pfenex for any violations of this Article 4.

 

[*] Certain information in this document 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 5

MANUFACTURING OF COLLABORATION PRODUCTS

5.1 General . As between the Parties, Agila shall be solely responsible for manufacturing any Collaboration Product(s) for any pre-clinical studies, the first Phase I Clinical Trial for any Collaboration Product(s) and otherwise in support of the Development Plan therefor at its own costs in the Facilities. All Collaboration Product(s) supplied by Agila hereunder for use in any Phase I Clinical Trial shall meet the applicable Specifications therefor and shall be manufactured at the Facility in accordance with the applicable Manufacturing Process and all Applicable Laws (including GMP). Agila shall perform quality control procedures reasonably necessary to ensure that any Collaboration Product(s) for use in any clinical studies conform fully to the applicable Specifications.

5.2 Changes . Once transferred to Agila, neither Party shall make any changes to the Manufacturing Process, Specifications, Analytical Methods, Facility, Raw Materials or any other item in any manner that would reasonably cause any Collaboration Product for use in any clinical studies not to comply with the Specifications therefor or Applicable Laws, without the JSC’s prior written approval. If either Party desires any such change, it may request such change through the JSC. All such changes shall be documented in a writing signed by an authorized representative of each of Pfenex and Agila.

5.3 Deviations . Without limiting Section 5.2 above, in the event any material deviations occur during the course of the manufacture of any batch of any Collaboration Product for use in any clinical studies under this Agreement, Agila shall immediately provide the JSC with a detailed written description of such deviation. In addition, Agila shall undertake all reasonable and appropriate actions to investigate the cause of such deviation and to correct the same.

5.4 Agila Warranties . Agila represents and warrants that:

5.4.1 Collaboration Product . All Collaboration Product supplied by Agila hereunder shall comply with all Applicable Laws, GMPs and meet all Specifications, and Agila shall perform and document all manufacturing and supply activities contemplated herein in compliance with all Applicable Laws.

5.4.2 Facilities and Equipment . The Facility(ies), all equipment used for the manufacture of each Collaboration Product within the Facility(ies) and the activities contemplated herein complies with all Applicable Laws and Agila shall obtain and maintain all Consents including governmental registrations, permits, licenses and approvals necessary for Agila to manufacture each Collaboration Product, and otherwise to perform its obligations, under this Agreement.

5.5 Manufacturing Records . Agila shall generate and maintain complete and accurate records and samples as necessary to evidence compliance with this Agreement and all Applicable Laws and other requirements of applicable governmental authorities relating to the manufacture of each Collaboration Product, including validation data, stability testing data, certificates of analysis, certificates of origin of all raw materials, batch and lot records, quality

 

[*] Certain information in this document 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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control and laboratory testing, and any other data required by Applicable Laws. All such records and samples shall be maintained for such periods as may be required by Applicable Law. Upon request by Pfenex, Agila shall provide Pfenex (or its designee) reasonable access to, and copies and portions of, such records and samples, including all batch and lot records, and any supporting data relating thereto, including written investigations of any deviations that may have been generated from manufacturing, packaging, inspection, or testing processes.

5.6 Inspection . During the Term and such longer period required by Applicable Laws, upon at least ten (10) business days advance notice and at reasonable frequency, Pfenex shall have the right to inspect and audit, during regular business hours: (a) any Facility or any other location at which any of the manufacturing, processing or other activities relating to any Collaboration Product are performed hereunder; and (b) any of the manufacturing and quality control records and all other documentation relating to the manufacturing, processing and other activities with respect to any Collaboration Product (including any internal quality control audits or reviews. Such inspections and audits shall be for the purpose of ascertaining compliance with Applicable Laws, the Specifications and other aspects of this Agreement, reviewing correspondence, reports, filings and other documents from or to Regulatory Authorities to the extent related to the manufacturing, processing and other activities hereunder, approving, where appropriate, all variances from applicable requirements hereunder, and evaluating the implementation of all manufacturing and process changes pursuant to this Agreement. In performing any such audit or inspection, employees or consultants of Pfenex shall: (i) not unreasonably interfere with other activities of Agila being carried out at the location at which such audit or inspection is taking place; and (ii) observe all rules and regulations applicable to visitors and to individuals employed at the Facility which have been communicated by Agila to Pfenex in writing. Any information obtained by Pfenex through such inspections and audits shall be treated as Confidential Information of Agila in accordance with Article 9 below.

5.7 [*] Facility . Agila will use all reasonable efforts to ensure that all applicable testing and validation of the [*] Facility has been successfully completed, and all required Consents have been obtained, and such facility is otherwise ready and available for use in manufacture of each Collaboration Product as soon as practicable and in no event later than the earlier of (i) the time Agila or the JVC, as applicable, receives a manufacturing license for the applicable Collaboration Product from the applicable Regulatory Authority and (ii) the JVC is otherwise prepared to commercially launch such Collaboration Product. In the event that the [*] Facility is not so completed for commercial production, Agila shall make alternative arrangements to supply the Collaboration Product(s) to the JVC for commercialization under the terms and conditions set in the JVA.

Article 6

REGULATORY MATTERS

6.1 General . As between the Parties, Agila shall be solely responsible for Regulatory Filings, obtaining and maintaining all necessary Regulatory Approvals for the initiation and performance of the first Phase I Clinical Trial for each Collaboration Product; provided that all such activities shall be performed in a manner that is consistent with the applicable Development Plan developed in accordance with Section 3.1. As between the Parties, Agila shall assume all responsibilities of sponsors and investigators under Applicable Laws for

 

[*] Certain information in this document 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 first Phase I Clinical Trial for each Collaboration Product. Upon the transfer of any Collaboration Product to the JVC as provided in Section 3.9, Agila shall assign and deliver, or cause to be assigned and delivered, to the JVC, and the JVC shall assume control of, all Regulatory Filings and approvals (including Regulatory Approvals) and all communications with the applicable Regulatory Authorities with respect thereto obtained and maintained by Agila or its Affiliate in connection with the development of such Collaboration Product(s).

6.2 Meetings with Regulatory Authorities . Agila shall timely inform Pfenex as soon as reasonably practicable of any meetings scheduled with any Regulatory Authority concerning any Collaboration Product. As reasonably requested in a timely manner, Agila shall allow representatives from Pfenex to participate in such meetings with any Regulatory Authority.

6.3 Regulatory Filings . Reasonably in advance of the submission of any Regulatory Filing or material correspondence with applicable Regulatory Authorities for any Collaboration Product, Agila shall provide a copy of such document to Pfenex for its review and shall incorporate any reasonable comments and suggestions provided by Pfenex with respect thereto. Agila shall make available, directly, or through the JSC, copies of any Regulatory Filing or correspondence with applicable Regulatory Authorities for any Collaboration Product promptly after such Regulatory Filing or correspondence has been submitted to the applicable Regulatory Authority.

6.4 Regulatory Actions . Agila shall permit all applicable Regulatory Authorities to conduct such inspections of the Facility or any other location at which any of the manufacturing or development activities (including pre-clinical or clinical studies) relating to any Collaboration Product are performed, as such Regulatory Authorities may request in accordance with Applicable Laws and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters. Agila shall give Pfenex prompt written notice of any such inspections, and shall keep Pfenex informed about the results and conclusions of each such regulatory inspection, including actions taken by Agila to remedy conditions cited in such inspections. In addition, Agila shall allow Pfenex or its representative to assist in the preparation for and be present at such inspections for which it has advanced notice. Agila shall provide Pfenex with copies of any written inspection reports issued by any Regulatory Authority and all correspondence between Agila and any Regulatory Authority with respect thereto. Additionally, Agila agrees to promptly notify and provide Pfenex copies of any request, directive or other communication of the applicable Regulatory Authority relating to or otherwise that may affect any Collaboration Product or its manufacture or development. Prior to responding to any reports, requests, directive or other communications issued by any Regulatory Authority relating to or otherwise that may affect any Collaboration Product or its manufacture or development, Agila shall provide Pfenex a copy of its proposed response for Pfenex’s review and comments and Agila shall include any reasonable comments or recommendations provided by Pfenex with respect thereto prior to submitting such response to the applicable Regulatory Authority. Agila shall provide Pfenex a copy of its final response contemporaneously with submitting the response to the Regulatory Authority.

 

[*] Certain information in this document 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 7

RECORDS; INSPECTIONS

7.1 Record Keeping . Without limiting any other specific record-keeping obligations set forth in this Agreement or any Development Plan, each Party shall generate and maintain, during the Term and such longer period required by Applicable Laws, complete and accurate records related to its performance of its obligations under each Development Plan as necessary to evidence compliance with this Agreement and all Applicable Laws. Upon the transfer of any Collaboration Product to the JVC as provided in Section 3.9, each Party shall deliver, or cause to be delivered, to the JVC all records (or copies thereof) kept by such Party in accordance with this Section 7.1.

7.2 Inspection . Without limiting any other specific inspection provisions in this Agreement or any Development Plan, during the Term and such longer period required by Applicable Laws, at least ten (10) business days advance notice by a Party and at reasonable frequency, such Party shall have the right to inspect and audit, during regular business hours, the records kept by the other Party pursuant to Section 7.1. Such inspections and audits shall be for the purpose of ascertaining compliance with this Agreement and Applicable Laws. Any information obtained by the auditing Party through such inspections and audits shall be treated as Confidential Information of the audited Party in accordance with Article 9 below.

Article 8

DILIGENCE

8.1 Diligence . Each Party will expend, with respect to each objective set forth in this Agreement or otherwise assigned to such Party under any Development Plan, its reasonable, good faith efforts to accomplish such objective consistent with those efforts it normally expends to accomplish a similar objective under similar circumstances. It is understood and agreed that with respect to any Collaboration Product(s), each Party’s efforts will be substantially equivalent to those efforts and resources commonly used for pharmaceutical products owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential as such Collaboration Product taking into account all relevant factors. Without limiting the foregoing, each Party shall achieve the applicable milestones set forth in Exhibit 1 attached hereto (each, a “ Milestone ”) with respect to activities assigned to it under this Agreement or the applicable Development Plan within the corresponding timelines set forth in Exhibit 1 . For clarity, the date by which the Development Plan for each Collaboration Product shall be executed by the Parties shall each be a Milestone, and a failure to meet such Milestone with respect to a Collaboration Product shall trigger the termination right set forth in Section 3.1 with respect to such Collaboration Product.

Article 9

CONFIDENTIALITY

9.1 Confidential Information . The Parties may from time to time disclose to each other Confidential Information. “ Confidential Information ” means any information disclosed by one Party to the other Party hereto, which (i) if disclosed in tangible form is marked “confidential” or with other similar designation to indicate its confidential or proprietary nature,

 

[*] Certain information in this document 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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(ii) if disclosed orally, is identified as confidential or proprietary by the Party disclosing such information at the time of its initial disclosure and is confirmed in writing as confidential or proprietary by the disclosing Party within forty five (45) days after such initial disclosure, or (iii) is reasonably expected to be treated in a confidential manner based on the nature of such information and the circumstances of its disclosure. For clarity, the terms of this Agreement and all Study Results shall be deemed Confidential Information of both Parties. Notwithstanding the foregoing or anything herein to the contrary, a receiving Party’s obligations under this Article 9 shall not apply to any information that, in each case as demonstrated by written documentation: (a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (d) was subsequently lawfully disclosed to the receiving Party by a Person other than the disclosing Party; or (e) was independently developed by the receiving Party without use of or reference to any Confidential Information of the disclosing Party.

9.2 Confidentiality . During the Term of this Agreement and for five (5) years thereafter without regard to the means of termination (or if the JVA is entered into, then such longer period as required by the JVA), neither Party shall use, for any purpose other than the purpose of this Agreement including (i) in connection with the performance of its obligations or exercise of rights granted to such Party in this Agreement and (ii) to the extent such disclosure is reasonably necessary in filing for, prosecuting or maintenance of patents and other intellectual property rights (including applications therefor) in accordance with this Agreement, prosecuting or defending litigation, complying with applicable governmental regulations, filing for, conducting preclinical or clinical trials, obtaining and maintaining regulatory approvals, or otherwise required by Applicable Laws or the rules of a recognized stock exchange, reveal or disclose to any Third Party other than consistent with such use including to potential investors, acquirers, investment bankers, lenders or their respective advisors and attorneys, Confidential Information and materials disclosed by the other Party (whether prior to or during the Term of this Agreement) without first obtaining the written consent of the other Party. The Parties agree to take all necessary steps to ensure that Confidential Information is securely maintained and to inform those who are authorized to receive such Confidential Information of their obligations under this Agreement and subject to written non-disclosure, non-use requirements consistent with this Article 9. Upon the termination or expiration of this Agreement for any reason (unless the JVA is entered into, then as required in the JVA), the receiving Party promptly shall, upon request by the disclosing Party, return all such Confidential Information, and any copies or reproductions thereof, to the disclosing Party and agrees to make no further use of such Confidential Information, except it may retain one copy thereof solely for use in complying with any record keeping and other obligations within such Party’s jurisdiction.

9.3 Reasonable Precautions . The Parties shall take all reasonable precautions to prevent the use or disclosure of such Confidential Information of the other Party without first obtaining the written consent of the other Party, except in accordance with Section 9.2 which may require disclosure to a governmental authority, regulatory authority, pricing authority in the Territory or otherwise required to be disclosed for diligence exercise for any transaction in connection with the development of any Collaboration Product in accordance herewith which may involve any Third Party, government authority, customer, bank, fund raising institution subject to written non-disclosure, non-use requirements consistent with this Article 9.

 

[*] Certain information in this document 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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9.4 Publicity Review .

9.4.1 Press Releases and Public Announcements . Neither Party shall issue any press release or other publicity materials, or make any public presentation with respect to this Agreement, the terms or conditions of this Agreement, or any Collaboration Product including with respect to any Study Results without the prior written consent of the other Party (such consent not to be unreasonably withheld, conditioned or delayed). The restrictions provided in this Section 9.4.1 shall not apply to disclosures required by Applicable Law, including as may be required in connection with any filings made with the Securities and Exchange Commission or similar non-U.S. regulatory authority, or by the disclosure policies of a major stock exchange; provided that each Party shall use good faith efforts to provide any such disclosure at least five (5) business days prior to such disclosure (to the extent practicable) for the other Party’s review and comment.

9.4.2 Use of Names . Neither Party shall utilize the name or trademarks of the other Party or make any disclosures concerning this Agreement, without the other Party’s prior written consent, provided that such use or disclosure shall be permitted if required by Applicable Laws and the Party making such use or disclosure consults with the other Party to the extent practicable not less than thirty (30) days prior the use or disclosure.

9.5 Prior Agreement . This Agreement supersedes the terms and conditions of the Confidentiality Agreement between the Parties dated May 2, 2012 (“ Prior Confidentiality Agreement ”) with respect to information disclosed thereunder. All information exchanged between the Parties under such Prior Confidentiality Agreement shall be deemed Confidential Information of the disclosing Party and shall be subject to the terms of this Article 9.

Article 10

INTELLECTUAL PROPERTY

10.1 Background Technology . Except for the limited licenses granted under Section 10.2 below, as between the Parties, each Party retains full right, title and interest in and to its Background Technology. Unless otherwise expressly set forth in this Agreement, each Party shall be fully responsible for obtaining and maintaining, at its own expense, ownership of or appropriate license to any technologies (and intellectual property rights therein) that are necessary for its performance of its obligations under each Development Plan. Without limiting the generality of the foregoing, Agila shall be solely responsible for developing or acquiring (including licensing or acquiring rights or assets from any Third Party), subject to the oversight and consent of the JSC, any PEGylation technology that is necessary for the development of PEGylated Interferon beta-1B, PEGylated Granulocyte Colony-Stimulating Factor, PEGylated L-Asparaginase and any additional PEGylated Collaboration Products as further provided in the applicable Development Plan. Agila shall be responsible for all costs associated with the development or acquisition of any such PEGylation technologies, except for any royalty payable to a Third Party upon the sale of any Collaboration Product(s) in which such PEGylation technologies are incorporated, which royalty will be borne by the JVC.

 

[*] Certain information in this document 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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10.2 License Grant

10.2.1 License to Agila . Pfenex hereby grants to Agila a non-exclusive, worldwide, fully-paid up, royalty-free license under Pfenex’s Background Technology and any Collaboration Technology solely owned by Pfenex pursuant to this Article 10, together with all intellectual property rights therein, solely to the extent necessary for Agila to perform the activities allocated to it under this Agreement and the applicable Development Plan during the Term.

10.2.2 License to Pfenex . Agila hereby grants to Pfenex a non-exclusive, worldwide, fully-paid up, royalty-free license under Agila’s Background Technology and any Collaboration Technology solely owned by Agila pursuant to this Article 10, together with all intellectual property rights therein, solely to the extent necessary for Pfenex to perform the activities allocated to it under this Agreement and the applicable Development Plan during the Term.

10.2.3 No Other Right . All rights and licenses granted under this Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by either Party to the other Party.

10.3 Collaboration Technology . Except as provided in Sections 10.4 and 10.5 and subject to Section 10.6, as between the Parties all right, title and interest to inventions and other subject matter (together with all intellectual property rights therein) conceived or created or first reduced to practice in connection with the exercise of rights or performance of obligations under this Agreement (collectively, “ Collaboration Technology ”) (i) by or under the authority of Pfenex or its Affiliates, independently of Agila and its Affiliates, shall be owned by Pfenex, (ii) by or under the authority of Agila or its Affiliates, independently of Pfenex and its Affiliates, shall be owned by Agila, and (iii) by personnel of Pfenex or its Affiliates and Agila or its Affiliates shall be jointly owned by Pfenex and Agila. Except as expressly provided otherwise in this Agreement, neither Party shall have any obligation to obtain any approval of the other Party for, nor pay the other Party any share of the proceeds from or otherwise account to the other Party for, the practice, enforcement, licensing, assignment or other exploitation of such jointly owned Collaboration Technology, and each Party hereby waives any right it may have under the Applicable Laws of any country to require such approval, sharing or accounting. Except as otherwise expressly provided hereunder, the Party that owns any particular Collaboration Technology shall, as between the Parties, have the sole and exclusive right to control the filing for, prosecution, maintenance and enforcement of any intellectual property rights therein in its sole discretion and any jointly owned Collaboration Technology will be prosecuted, maintained and enforced as determined by the intellectual property Subcommittee in accordance with the procedures set forth in Section 2.7.

10.4 Pfenex Improvements . Notwithstanding Section 10.3 above, all Pfenex Improvements will be the sole and exclusive property of Pfenex, and Agila hereby assigns to Pfenex all Pfenex Improvements. Agila will promptly disclose to Pfenex any and all Pfenex Improvements and take such other reasonable actions at Pfenex’s request and expense to

 

[*] Certain information in this document 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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effectuate such assignment. As used herein, “ Pfenex Improvements ” means: all modifications and improvements to any Pfenex Expression Technology or Pfenex Materials and Deliverables and all inventions claiming the use of Pfenex Expression Technology that are not solely applicable to any Collaboration Product, together with all intellectual property rights pertaining to the foregoing.

10.5 Agila Improvements . Notwithstanding Section 10.3 above, all Agila Improvements will be the sole and exclusive property of Agila. As used herein, “ Agila Improvements ” means all modifications and improvements to any Agila’s proprietary manufacturing and/or formulation technologies that are not (a) solely applicable to any Collaboration Product or (b) based upon or include any Pfenex Expression Technology, Pfenex Materials and Deliverables or Confidential Information of Pfenex, together with intellectual property rights pertaining to the foregoing.

10.6 Assignment to JVC . Upon the transfer of any Collaboration Product to the JVC as provided in Section 3.9, each Party shall assign, or cause to be assigned, to the JVC, all of its right, title and interest in and to any Collaboration Technology (excluding any Pfenex Improvement) arising from the performance of the applicable Development Plan and the JVC shall have the sole and exclusive right to control the filing for, prosecution, maintenance and enforcement of any intellectual property rights in such Collaboration Technology in its sole discretion. Each Party shall grant to the JVC appropriate licenses to its Background Technology to enable the JVC to further develop and commercialize the applicable Collaboration Product.

10.7 Disclosure and Cooperation . Each Party shall promptly disclose to the other Party any Collaboration Technology generated hereunder. The Parties shall at all times fully cooperate in order to reasonably implement the provisions of this Article 10. Such cooperation may include the execution of necessary legal documents, coordinating prosecution to avoid or mitigate any patentability issues, and the provision of any other assistance reasonably requested by the other Party at such other Party’s expenses.

Article 11

TERM AND TERMINATION

11.1 Term . The term of this Agreement shall commence on the Effective Date and shall continue on a Collaboration Product-by-Collaboration Product basis until the Successful Completion of the first Phase I Clinical Trial for the applicable Collaboration Product (“ Term ”). For clarity, prior to each Party signing the applicable Development Plan for a particular Collaboration Product hereunder as set forth in Section 3.1, neither Party shall have any rights or obligations hereunder with respect to such product, except that the Parties will use good faith efforts to prepare and agree on Development Plan in accordance with Section 3.1 for each product described in Section 1.6(a) – (e) unless either Party prior to the signing of the Development Plan for such product provides sixty (60) days’ prior written notice to the other Party that it desires to exclude such product herefrom, in which case, such product shall be excluded; provided that if the other Party desires the Parties shall discuss the basis for such exclusion during such sixty (60) day period.

 

[*] Certain information in this document 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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11.2 Termination for Material Breach . If either Party materially breaches this Agreement, the non-breaching Party shall have the right to terminate this Agreement, in its entirety or with respect to any Collaboration Product that is subject to the applicable Development Plan under which such material breach occurs, by written notice to the breaching Party specifying the breach and referencing this Section 11.2, if such breach is not cured within ninety (90) days after written notice is given by the non-breaching Party to the breaching Party specifying the breach; provided, however, that in the event of a good faith dispute with respect to the existence of a material breach, this Agreement or the applicable Development Plan shall not be terminated unless it is finally determined pursuant to Section 14.10 such material breach has occurred, and the breaching party fails to cure such breach within ninety (90) days after such determination.

11.3 Termination for Insolvency . Each Party shall have the right to terminate this Agreement upon delivery of written notice to the other Party in the event that (i) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (ii) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within ninety (90) days of its filing, or (iii) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors.

11.4 Termination for Failure to Enter into the JVA . In the event the Parties fail to enter into the JVA pursuant to Section 3.8 by February 28, 2013, this Agreement shall terminate automatically unless otherwise mutually agreed by the Parties in writing.

11.5 Cross Termination with the JVA . In the event the JVA is terminated in its entirety in accordance with its terms, this Agreement shall terminate automatically unless otherwise mutually agreed by the Parties in writing.

11.6 Effects of Termination .

11.6.1 Expiration or termination of this Agreement (in its entirety or with respect to any Collaboration Product) for any reason shall not release either Party of any obligation or liability which, at the time of such expiration or termination, has already accrued to such Party or which is attributable to a period prior to such expiration or termination.

11.6.2 Upon expiration or termination of this Agreement (in its entirety or with respect to any Collaboration Product), all rights and licenses to any technology and intellectual property rights therein granted by either Party to the other Party under this Agreement or with respect to the applicable terminated Collaboration Product, as applicable, shall terminate and revert back to the Party granting such rights or licenses.

11.6.3 Upon termination of this Agreement or with respect to any Collaboration Product(s), each Party shall cease all work under this Agreement or the applicable Development Plan, as applicable, except for activities as necessary for an orderly wind-down of the performance of this Agreement or the applicable Development Plan, and return to the other

 

[*] Certain information in this document 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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Party all Confidential Information of the other Party and unused materials provided to it by the other Party under this Agreement or the applicable Development Plan, as applicable, and all copies and embodiments thereof, except that each Party may retain one copy of the other Party’s written Confidential Information in its confidential files solely for archival purposes. Without limiting the generality of the foregoing, upon termination of this Agreement (in its entirety or with respect to any Collaboration Product), Agila shall immediately cease any use or practice of Pfenex Materials and Deliverables provided under this Agreement or under the applicable Development Plan, as applicable, and return all remaining Pfenex Materials and Deliverables in Agila’s possession, including all embodiments or derivatives thereof.

11.6.4 Upon expiration of this Agreement with respect to any Collaboration Product(s), in the event such Collaboration Product(s) is transferred to the JVC as provided in Section 3.9, each Party shall fully cooperate with each other to facilitate a smooth, orderly and prompt transfer of such Collaboration Product(s) to the JVC. Without limiting the generality of the foregoing, (i) Agila shall assign or cause to be assigned to the JVC all Regulatory Filings and Regulatory Approvals and all communications with the applicable Regulatory Authorities obtained or maintained by or on behalf of Agila under this Agreement with respect to such Collaboration Product(s), (ii) each Party shall assign all of its right, title and interest in and to any Collaboration Technology (excluding Pfenex Improvements) to the JVC, and (iii) each Party shall transfer to the JVC all records, reports and other work products generated during its performance of the applicable Development Plan.

11.6.5 Upon expiration of this Agreement with respect to any Collaboration Product, in the event such Collaboration Product(s) is not transferred to the JVC as provided in Section 3.9, unless otherwise mutually agreed by the Parties, each Party shall return to the other Party all Confidential Information of the other Party and unused materials provided to it by the other Party (including Pfenex Materials and Deliverables provided to Agila) under this Agreement or the applicable Development Plan, as applicable, and all copies and embodiments thereof, except that each Party may retain one copy of the other Party’s written Confidential Information in its confidential files solely for archival purposes. Upon expiration of this Agreement with respect to any Collaboration Product, in the event such Collaboration Product(s) is not transferred to the JVC as provided in Section 3.9, if Pfenex elects to continue the development of such Collaboration Product, the Parties shall discuss in good faith terms and conditions that are reasonable and customary in the pharmaceutical industry pursuant to which Agila will transfer all Regulatory Approvals obtained or maintained by or on behalf of Agila under this Agreement with respect to such Collaboration Product (together with all relevant Regulatory Filings and correspondence with Regulatory Authorities) and granting Pfenex a license to all technologies and associated intellectual property rights owned or controlled by Agila that are necessary or useful for the development and commercialization of such Collaboration Product.

11.7 Survival . The provisions of Articles 1, 7, 9, 13 and 14, and Sections 4.3, 5.5, 5.6, 5.7, 10.1, 10.2.3, 10.3-10.7, 11.6, 11.7, 12.2 (last sentence) and 12.3 shall survive the termination of this Agreement for any reason. All other rights and obligations of the Parties shall cease upon termination of this Agreement. Except as otherwise expressly provided in this Section 11.7, all other rights and obligations of the Parties shall terminate.

 

[*] Certain information in this document 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 12

REPRESENTATIONS AND WARRANTIES

12.1 Mutual Representations and Warranties . Each Party represents and warrants to the other Party that: (a) as of the Effective Date, it has the power and authority to enter into this Agreement and to perform its obligations hereunder and to grant to the other Party the rights granted to such other Party under this Agreement; (b) as of the Effective Date, it has obtained all necessary corporate and other approvals to enter into and execute this Agreement; and (c) it is not, as of the Effective Date, a party to, nor will it enter into or assume during the Term, any contract or other obligation with a Third Party that would in any way limit the performance of its obligations under this Agreement (d) this Agreement will, when executed, constitute valid and binding obligations on the Parties; and (e) entry into and performance by it of this Agreement will not (i) breach any provision of its bylaws or equivalent constitutional documents; or (ii) result in a breach of any Applicable Laws in its jurisdiction of incorporation or of any order, decree or judgment of any court or any Regulatory Authority, where any such breach would affect to a material extent its ability to enter into or perform its obligations under this Agreement.

12.2 No Debarment . Each Party further represents and warrants that neither it, nor any of its Affiliates, nor any of their respective employees or contractors involved in the performance of this Agreement have been “debarred” by the FDA pursuant to 21 U.S.C. § 335a or subject to a similar sanction from any Regulatory Authority in any other jurisdiction, nor have debarment or similar proceedings against such Party, any of its Affiliates, or any of their respective employees or contractors involved in the performance of this Agreement been commenced. Each Party will promptly notify the other Party in writing if any such proceedings are commenced or if such Party, any of its Affiliates, or any of their respective employees or contractors involved in the performance of this Agreement are debarred or similarly sanctioned by any Regulatory Authority.

12.3 DISCLAIMERS .

12.3.1 GENERAL . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTIES (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY OR NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.

12.3.2 PFENEX MATERIALS AND DELIVERABLES . EXCEPT AS PROVIDED IN SECTION 4.2, THE PFENEX MATERIALS AND DELIVERABLES ARE PROVIDED “AS-IS.”

12.4 LIMITATION OF LIABILITY . NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES INCLUDING, BUT NOT LIMITED TO LOST PROFITS ARISING FROM OR RELATING TO THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE

 

[*] Certain information in this document 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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POSSIBILITY OF SUCH DAMAGES. HOWEVER, NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER ARTICLE13.

Article 13

INDEMNIFICATION

13.1 Pfenex . Pfenex shall indemnify, defend and hold harmless Agila, its directors, officers, employees, agents, successors and assigns from and against any liabilities, expenses or costs (including reasonable attorneys’ fees and court costs) arising out of any claim, complaint, suit, proceeding or cause of action against any of them by a Third Party resulting from: (a) the negligent or intentionally wrongful acts or omissions of Pfenex, its Affiliates and subcontractors during the performance of any Development Plan or (b) any breach by Pfenex of its representations and warranties under this Agreement; in each case, subject to the requirements set forth in Section 13.3 below. Notwithstanding the foregoing, Pfenex shall have no obligations under this Article 13 for any liabilities, expenses or costs arising out of or relating to claims to the extent covered under Section 13.2 below.

13.2 Agila . Agila shall indemnify, defend and hold harmless Pfenex, its directors, officers, employees, agents, successors and assigns from and against all liabilities, expenses, and costs (including reasonable attorneys’ fees and court costs) arising out of any claim, complaint, suit, proceeding or cause of action against any of them by a Third Party resulting from: (a) the negligent or intentionally wrongful acts or omissions of Agila, its Affiliates and subcontractors during the performance of any Development Plan or (b) any breach by Agila of any of its representations and warranties under this Agreement; in each case, subject to the requirements set forth in Section 13.3 below. Notwithstanding the foregoing, Agila shall have no obligations under this Article 13 for any liabilities, expenses or costs arising out of or relating to claims to the extent covered under Section 13.1 above.

13.3 Indemnification Procedure . Any Party seeking indemnification under this Article 13 (the “ Indemnitee ”) shall: (a) promptly notify the indemnifying Party (the “ Indemnitor ”) of such claim; (b) provide the Indemnitor sole control over the defense or settlement thereof; and (c) at the Indemnitor’s request and expense, provide full information and reasonable assistance to Indemnitor with respect to such claims. Without limiting the foregoing, with respect to claims brought under Section 13.1 or 13.2 above the Indemnitee, at its own expense, shall have the right to participate with counsel of its own choosing in the defense or settlement of any such claim. The indemnification under this Article 13 shall not apply to amounts paid in settlement of any claim if such settlement is effected without the consent of the Indemnitor.

13.4 Insurance . Each Party will procure and maintain, at its own expense, insurance, with a financially sound and reputable insurer, reasonably sufficient to cover such Party’s activities and its obligations under this Agreement with minimum coverage amounts customary for the activities of such Party hereunder in the jurisdiction(s) where such activities are performed or such other minimums as the JSC may establish. Without limiting the foregoing, Agila shall procure and maintain clinical trial insurance with minimum coverage amounts customary for Phase I Clinical Trials in the jurisdiction(s) where such clinical studies

 

[*] Certain information in this document 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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are performed or such other minimums as the JSC may establish. Each Party will furnish at the request of the other Party a certificate(s) reflecting relevant insurance coverage and limits. Each Party will name the other as an additional insured on the policies for the coverage required herein.

Article 14

GENERAL PROVISIONS

14.1 Affiliates . Each Party may perform any obligations and exercise any rights hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement will be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

14.2 Assignment . Each Party agrees that its rights and obligations under this Agreement may not be assigned or otherwise transferred to a Third Party without the prior written consent of the other Party hereto. Notwithstanding the foregoing, either Party may transfer or assign its rights and obligations under this Agreement to (a) an Affiliate, subject to the prior notice to the other Party and the assigning Party remaining responsible for such Affiliate’s performance or (b) a successor to all or substantially all of its business or assets relating to this Agreement whether by sale, merger, operation of law or otherwise, without the prior written consent of the other Party; provided that such assignee or transferee has agreed to be bound by the terms and conditions of this Agreement. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties hereto, their successors and assigns.

14.3 Severability . If any clause, provision, or Section of this Agreement attached hereto, shall, for any reason, be held illegal, invalid or unenforceable, the Parties shall negotiate in good faith and in accordance with reasonable standards of fair dealing, a valid, legal, and enforceable substitute provision or provisions that most nearly reflect the original intent of the Parties under this Agreement in a manner that is commensurate in magnitude and degree with the changes arising as a result of any such substitute provision or provisions. All other provisions in this Agreement shall remain in full force and effect and shall be construed in order to carry out the original intent of the Parties as ‘nearly as possible (consistent with the necessary reallocation of benefits) and as if such invalid, illegal, or unenforceable provision had never been contained herein.

14.4 Merger of Understandings; Amendment . This Agreement (and the Exhibits attached hereto and Purchase Orders issued pursuant hereto) and the Quality Agreement constitute the entire agreement between the Parties regarding the subject matter hereof and all prior negotiations and understandings between the Parties are deemed to be merged into this Agreement. No agreement or understanding varying or extending this Agreement shall be binding upon either Party hereto, unless set forth in a writing which specifically refers to the Agreement signed by duly authorized officers or representatives of the respective Parties, and the provisions hereof not specifically amended thereby shall remain in full force and effect.

 

[*] Certain information in this document 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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14.5 Waiver . Any waiver of the terms and conditions hereof must be explicitly in writing and executed by a duly authorized officer of the Party waiving compliance. The waiver by either of the Parties of any breach of any provision hereof by the other shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself. The delay or failure of any Party at any time to require performance of any provision of this Agreement shall in no manner affect such Party’s rights at a later time to enforce the same.

14.6 Notices . Any notice, report or other communication required or permitted to be given by either Party under this Agreement shall be given in writing and may be delivered by hand, reputable international 3- or 4-day courier service or by mailing if mailed by registered or certified mail, postage prepaid and return receipt requested (or the international equivalent), or by email or fax (with printed confirmation of transmission and with confirmation copy forwarded by reputable international 3- or 4-day courier service), addressed to each Party as follows. Such information may be updated by a Party upon written notice to the other Party. A notice shall be deemed delivered upon receipt, unless the notice is received on a day other than a business day in the jurisdiction of the recipient or after 5:30 p.m. at the location of delivery, in which case delivery shall be deemed to be the next business day after receipt (as determined in the jurisdiction of recipient).

 

For Pfenex:    Pfenex Inc.
   10790 Roselle Street
   San Diego, CA 92121
   Attn: Patrick Lucy
   Fax: +1 978 887-4972
   Email: PKL@Pfenex.com
For Agila:    Agila Biotech Private Limited
   Strides House, Bilekahalli
   Bannergahtta Road,
   Bangalore 560 076, INDIA
   Attention: Legal Department
   Fax: + 91 80 6784 0700 / 800
   Email: legal@stridesarco.com

14.7 Force Majeure . Neither of the Parties shall be liable for any default or delay in performance of any obligation under this Agreement caused by any of the following: Act of God, war, terrorism, riot, fire, explosion, accident, flood, sabotage, compliance with governmental requests, laws, regulations, orders or actions, national defense requirements or any other event beyond the reasonable control of such Party, or labor trouble, strike, lockout or injunction (provided that neither of the Parties shall be required to settle a labor dispute against its own best judgment). The Party invoking the provisions of this Section14.7 shall give the other Party written notice and full particulars of such force majeure event. Both Pfenex and Agila shall use reasonable business efforts to mitigate the effects of any force majeure on their respective part.

14.8 Relationship of the Parties . The relationship of Pfenex and Agila is strictly one of independent contractors and the Parties acknowledge that this Agreement does not

 

[*] Certain information in this document 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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create a joint venture, partnership, or the like, between them. Pfenex and Agila shall always remain independent contractors in its performance of this Agreement. Neither Party shall have any authority to employ any individual as an employee or agent for or on behalf of the other Party to this Agreement for any purpose, and neither Party, nor any person performing any duties or engaging in any work at the request of such Party, shall be deemed to be an employee or agent of the other Party.

14.9 Choice of Law . All questions with respect to the construction of this Agreement and the rights and liabilities of the Parties hereto shall be determined in accordance with the laws of England and Wales, without regard to any provisions of conflicts of law and shall not be governed by the United Nations Convention on Contracts for the International Sale of Goods.

14.10 Dispute Resolution .

14.10.1 General . If the Parties are unable to resolve any dispute or other matter arising out of or in connection with this Agreement, either Party may, by written notice to the other, have such dispute referred to the Chief Executive Officers of Parties for attempted resolution by good faith negotiations promptly after such notice is received. In such event, each Party shall cause its Chief Executive Officers to meet (face-to-face or by teleconference) and be available to attempt to resolve such issue. If the Parties should resolve such dispute or claim, a memorandum setting forth their agreement will be prepared and signed by both Parties if requested by either Party. The Parties shall cooperate in an effort to limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the dispute.

14.10.2 Arbitration . In the event that the Parties are unable to resolve any such matter subject to Section 14.10.1 within sixty (60) days from the date such dispute was referred to the Chief Executive Officers of the Parties, then either Party may initiate arbitration pursuant to this Section 14.10.2. Any arbitration under this Section 14.10.2 shall be conducted in English under the Arbitration Rules of the Singapore International Arbitration Centre (“ SIAC ”) in Singapore by a single arbitrator mutually selected by the Parties or otherwise selected in accordance with such rules. In such arbitration, the arbitrator shall select an independent expert with significant experience relating to the subject matter of such dispute to advise the arbitrator with respect to the subject matter of the dispute. If the Parties are unable to agree on an arbitrator, the arbitrator shall be selected by the chief executive of SIAC. The costs of such arbitration shall be shared equally by the Parties, and each Party shall bear its own expenses in connection with the arbitration. The parties shall use good faith efforts to complete arbitration under this Section 14.10.2 within sixty (60) days following the initiation of such arbitration. The arbitrator shall establish reasonable additional procedures to facilitate and complete such arbitration within such sixty (60) day period. Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief.

14.11 Provisions Contrary to Law . In performing this Agreement, the Parties shall comply with all Applicable Laws. Nothing in this Agreement shall be construed so as to require the violation of any law, and wherever there is any conflict between any provision of this Agreement and any law the law shall prevail, but in such event the affected provision of this Agreement shall be affected only to the extent necessary to bring it within the Applicable Laws.

 

[*] Certain information in this document 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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14.12 Legal Fees . Except as otherwise provided herein, each Party shall bear its own legal fees incurred in connection with the transactions contemplated hereby or the enforcement hereof.

14.13 Headings . Headings herein are for convenience of reference only and shall in no way affect interpretation of this Agreement.

14.14 Counterparts . This Agreement may be executed in any number of counterparts with the same effect as if all Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.

14.15 Exhibits . The appended Exhibits and any modifications or amendments thereof form an integral part of this Agreement.

[The remainder of this page left blank intentionally; signature page follows immediately behind]

 

[*] Certain information in this document 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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CONFIDENTIAL

EXECUTION COPY

IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Agreement as of the Effective Date.

 

PFENEX INC.     AGILA BIOTECH PRIVATE LIMITED
By:  

/s/ Bertrand C. Liang

    By:  

/s/ Anand Iyer

Name:  

Bertrand C. Liang

    Name:  

Anand Iyer

Title:  

CEO

    Title:  

CEO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Exhibit 1

Milestones and Timelines

[*]

 

[*] Certain information in this document 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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Exhibit 2

Amounts to be reimbursed

Agila will reimburse Pfenex for amounts incurred as of the Effective Date with respect to the conduct of activities for cGMP manufacturing, toxicology or any [*] for the Collaboration Product comprising [*] within thirty (30) days of receipt of invoice therefor and other customary documentation. Without limiting the foregoing, the Parties will discuss how to address any other amounts due under the existing agreements with Syngene International Limited and Novotech (Australia) Pty Limited including assigning such agreements to Agila.

[*]

[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-3-


Exhibit 3

Exceptions to Exclusivity

[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-4-

Exhibit 10.7

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].”

CONFIDENTIAL

EXECUTION COPY

PFENEX INC.

AND

AGILA BIOTECH PRIVATE LIMITED

JOINT VENTURE AGREEMENT

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


JOINT VENTURE AGREEMENT

This Joint Venture Agreement (this “ Agreement ”) is made as of the 7 th day of March 2013 (the “ Effective Date ”), by and between Pfenex Inc., a Delaware corporation with a principal place of business located at 10790 Roselle Street, San Diego, CA 92121 (“ Pfenex ”), and Agila Biotech Private Limited, an India corporation with a principal place of business located at Strides House, Bilekahalli, Bannerghatta Road, Bangalore 560 076, India (“ Agila ”). Pfenex and Agila may be referred to individually as a “ Party ” or together as the “ Parties .”

BACKGROUND

A. Pfenex has a proprietary Pseudomonas fluorescens protein expression platform, which is used to accelerate the development and production of bio-therapeutics and vaccines;

B. Agila is engaged in the business of developing, manufacturing and supplying therapeutic biological products for research and development and commercial purposes;

C. Pursuant to a Joint Development and License Agreement entered into by the Parties dated December 31, 2012 (the “ JDLA ”), the Parties will develop certain therapeutic biological products manufactured using the Pfenex Expression Technology (as defined in section 1.18 of the JDLA) through the completion of the first Phase I Clinical Trial (as defined in section 1.19 of the JDLA) for each such product in accordance with the terms and conditions of this Agreement;

D. Pfenex and Agila wish to establish a joint venture company to further develop and commercialize one or more such products after the completion of the first Phase I Clinical Trial pursuant to the terms and conditions of this Agreement and the applicable plan and budget mutually agreed by the Parties.

NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the Parties, the Parties agree as follows:

1. DEFINITIONS AND INTERPRETATIONS

Initially capitalized terms shall have the meanings set forth below or defined elsewhere in the Agreement. And if not defined in this Agreement, shall have the meanings assigned to them in the MLA. In the event any initially capitalized term used in this Agreement is defined both in this Agreement and the JDLA, the definition set forth in this Agreement shall control for the purposes of this Agreement.

1.1. “ Acceptable Third Party Supplier ” means a Third Party supplier that holds all necessary licenses and permits, including relevant GMP certification and permissions, required by Applicable Laws to manufacture the relevant JVC Product or component thereof and meets the JVC quality specifications.

1.2. “ Affiliate ” means, with respect to a Person (as defined in section 1.17 of the JDLA), any other Person controlling, controlled by or under common control with such first Person, for so

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


long as such control exists. For the purposes of this definition only, “control” means: (a) to possess, directly or indirectly, the power to direct the management and policies of such Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) ownership of more than fifty percent (50%) of the voting securities in such Person (or such lesser percent as may be the maximum that may be owned pursuant to Applicable Laws of the country of incorporation or domicile, as applicable) or is a subsidiary of the same entity of which a Party is a subsidiary. For clarity, for purposes of this Agreement, the JVC shall not be deemed an Affiliate of either Party.

1.3. “ Applicable Laws ” means any laws, statutes, rules, regulations, directives, or ordinance applicable to the JVC or the activities contemplated hereunder, together with any judgments, orders; notices, instructions, decisions, standards, guidance and awards, each having the force of law, issued by a court or competent authority or tribunal or a Regulatory Authority to which the JVC is subject, including as applicable, GCP (as defined in section 1.10 of the JDLA), GLP (as defined in section 1.12 of the JDLA), GMP (as defined in section 1.11 of the JDLA).

1.4. “ Background Technology ” means, with respect to a Party, any and all technology, know-how, technical information and other technical subject matter, and all intellectual property rights therein, in each case Controlled by such Party or its Affiliates as of the Effective Date or otherwise developed or acquired by or on behalf of such Party outside the performance of this Agreement, in each case that are necessary for the development and commercialization of JVC Products under this Agreement. For clarity, (i) Pfenex’s Background Technology includes the Pfenex Expression Technology, including to the extent it is embodied in the applicable Pfenex Materials and Deliverables (as defined in section 4.1.1 under the JDLA) with respect to any JVC Product, and (ii) in the event JVC Products include any PEGylated product, Agila’s Background Technology includes the PEGylation technology developed and/or acquired by Agila as provided in section 10.1 of the JDLA.

1.5. “ Business Day ” means a day (other than Saturday, Sunday or a public holiday) on which banks generally are open in the United States of America and India for a full range of business.

1.6. “ Clinical Trial ” means any clinical trial of a JVC Product to be conducted pursuant to a Plan and Budget or Semi-annual Plan and Budget. For clarity, Clinical Trials shall not include any Phase I Clinical Trial conducted pursuant to the JDLA.

1.7. “ Committee ” means each of the Operations Committee and Finance Committee.

1.8. “ Completion Date ” means a date when all the conditions listed in Section 2.4 are fully satisfied.

1.9. “ Control ” means the possession (whether by ownership, license or other authorization), as of the Effective Date or during the Term, of (a) with respect to materials, data or information, physical possession or the right to such physical possession of those items, and the right to provide them to others (including the other Party) in accordance with this Agreement; and (b) with respect to intellectual property rights, the right sufficient to grant the applicable license or sublicense under this Agreement; in each case without violating the terms of any agreement with

 

[*] Certain information in this document 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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any Third Party. Notwithstanding anything to the contrary in this Agreement, the following shall not be deemed to be Controlled by a Party: (i) any materials, data, information or intellectual property owned or licensed by any Acquiring Entity immediately prior to the effective date of merger, consolidation or transfer, and (ii) any materials, data, information or intellectual property that any Acquiring Entity subsequently develops independently, without accessing or practicing the Pfenex Background Technology (in the case of an Acquiring Entity of Pfenex) or the Agila Background Technology (in the case of an Acquiring Entity of Agila). As used herein, “ Acquiring Entity ” means a Third Party that merges or consolidates with or acquires a Party, or to which a Party transfers all or substantially all of its assets to which this Agreement pertains.

1.10. “ Financial Year ” means each period of twelve (12) months commencing on 1st January of a calendar year and ending on December 31st of the same calendar year or such other period as the Board may determine in accordance with Applicable Laws except with respect to the first Financial Year for the JVC which shall run from the Completion Date to the immediately following December 31st.

1.11. “ JVC ” means the joint venture company proposed to be incorporated by the Parties under this Agreement.

1.12. “ SVC Product ” means any Collaboration Product that is transferred to the JVC pursuant to section 3.9 of the JDLA.

1.13. “ JVC Venue ” means the jurisdiction of incorporation of the JVC, which shall be selected by the Parties in accordance with Section 2.1 from one of the following countries: Singapore or Malaysia.

1.14. “ Manufacturing Cost ” means, with respect to a JVC Product, the cost incurred by a manufacturer in the manufacturing of JVC Product, including the aggregate of such manufacturer’s costs for testing, labor, raw material, components, labeling, packaging, and other costs (including manufacturing overhead) directly allocable to manufacture and quality assurance; provided that Manufacturing Cost shall not include any such costs incurred due to such manufacturer’s gross negligence or willful misconduct. For clarity, Manufacturing Cost shall exclude general administrative or corporate overhead, sales and marketing expenses, research and development costs, interest expenses and any other costs not directly attributable or allocable to the manufacture of the applicable JVC Product, including idle capacity charges as the result or consequence of the plant being idle or a manufacturing line not being used (not including, for example, normal maintenance, changeovers or related activities). Manufacturing Cost shall be determined and allocated to each JVC Product (a) in accordance with such manufacturer’s accepted costing standards and all applicable generally acceptable cost and accounting standards as consistently applied by such manufacturer and (b) as reported in the manufacturer’s external financial results. The manufacturer shall use commercially reasonable efforts to operate the facility(ies) in which the applicable JVC Product is manufactured within their plant capacity utilization targeted range and to minimize the Manufacturing Costs for such JVC Product.

1.15. “ Marketing Approval ” means, with respect to a JVC Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the commercialization of such JVC Product in such jurisdiction, including only where mandatory for commercialization of such JVC Product, any necessary pricing or reimbursement approval.

 

[*] Certain information in this document 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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1.16. “ Regulatory Approval ” means all approvals, licenses, clearances, registrations or authorizations received from any Regulatory Authority in response to a Regulatory Filing together with all necessary approvals by any regulatory advisory board (e.g. institutional review board and ethics committee), including Marketing Approval.

1.17. “ Regulatory Authority ” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity ‘with authority over the development, manufacture or other commercialization (including the granting of Regulatory Approvals) of any JVC Product in any jurisdiction, including the Drugs Controller General of India, European Medicines Agency and the United States Food and Drug Administration (“ FDA ”) and, in each case, any successor entity thereto.

1.18. “ Regulatory Filings ” means any submission made to a Regulatory Authority with respect to a pharmaceutical or medicinal product, including any application necessary to commence or conduct clinical testing of such product in humans, any submission to a regulatory advisory board with respect to such product, any application to market such product, and in each case any supplement or amendment to any of the foregoing.

1.19. “ Shareholders ” shall mean each of Pfenex and Agila.

1.20. “ Shares ” means the equity shares of the JVC, each having a face value to be established in accordance with Section 2.1.

1.21. “ Territory ” means worldwide.

1.22. “ Third Party ” means an entity other than Pfenex, Agila, their respective Affiliates and the JVC.

1.23. Additional Defined Terms .

Each of the following terms shall have the meaning described in the corresponding section of this Agreement indicated below:

 

Term

  

Section of this Agreement Defined

Acceptance Notice    9.2.3
Acceptance Period    9.2.3
Appointing Party    4.1
Appraiser    14.5.1
Articles of Association    5.1
Board    4.1
Call Option    14.4.3
Call Option Exercise Notice    14.4.3
Call Option Purchase Price    14.4.3
Call Option Sold Equity    14.4.3

 

[*] Certain information in this document 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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Chairman    4.1
Confidential Information    12.1
Cure Period    14.4.2
Defaulting Party    14.4.1
Director    4.1
Disclosing Party    12.1
Disposing Shareholder    9.2.1
Event of Default    14.4.1
Finance Committee    6.2
Incorporation Permit    2.3
Indemnitee    16.4
Indemnitor    16.4
Interim Transfer Price    13.3
JDLA    Background
JVC Auditor    8.2
JVC Successor    14.7
JVC Technology    11.3
Losses    16.1
Manufacturing Agreements    7.1.1
Meeting Coordinator    4.4.3
Non-Defaulting Party    14.4.2
Non-Disposing Shareholder    9.2.1
Notice of Default    14.4.2
Notice of Election    14.3.1
Offer    14.3.1
Offer Price    9.2.2
Offered Party    14.3.1
Offered Share    9.2.2
Offered Tag Share    9.2.3
Offering Party    14.3.1
Operations Committee    6.1.1
Ownership Interest    3.1
Pfenex Improvements    11.3
Purchase Price Certificate    14.5.2
Put Option    14.4.4
Put Option Exercise Notice    14.4.4
Put Option Purchase Price    14.4.4
Put Option Sold Equity    14.4.4
Quality Agreement    7.1.3
Ratification Date    3.3
Receiving Party    12.1
Right of First Refusal    9.2.1
Semi-annual Plan and Budget    6.1.1
Shareholder Reserved Matter    5.5
SIAC    17.10.2
Subcommittee    6.1.2
Supply Price    7.1.2
Tag-Along Notice    9.2.3
Tag-Along Right    9.2.1
Term    14.1
Valuation Price    14.5.1

 

[*] Certain information in this document 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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Each of the following terms shall have the meaning described in the corresponding section of the JDLA indicated below:

 

Term

  

Section of the JDLA Defined

Collaboration Product    1.6
Facility    1.9
GCP    1.10
GLP    1.12
GMP    1.11
Malaysian Facility    1.9
PEGylation    1.16
Person    1.17
Pfenex Expression Technology    1.18
Pfenex Materials and Deliverables    4.1.1
Phase I Clinical Trial    1.19
Plan and Budget    3.9

1.24. Interpretation . The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles and Sections of or Exhibits to this Agreement and references to this Agreement include all Exhibits hereto. Unless context clearly requires otherwise, whenever used in this Agreement: (i) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation;” (ii) the word “or” shall have its inclusive meaning of “and/or;” (iii) the word “day” or “quarter” or “year” means a calendar day or calendar quarter or calendar year unless otherwise specified; (iv) the word “notice” shall require notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (v) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Agreement (including any Exhibits); (vi) provisions that require that a Party or the Parties hereunder “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise; (vii) words of any gender include the other gender; (viii) words using the singular or plural number also include the plural or singular number, respectively; (ix) references to any specific law, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement thereof; and (x) provisions that refer to Persons acting “under the authority of Pfenex” shall include Pfenex’s Affiliates or licensees, as applicable, and those Persons acting “under the authority of Agila” shall include Agila’s Affiliates or sublicensees, as applicable; conversely, those Persons acting “under the authority of Pfenex” shall exclude JVC, Agila, its Affiliates and sublicensees, as applicable, and those Persons acting “under the authority of Agila” shall exclude JVC, Pfenex, its Affiliates and licensees, as applicable.

 

[*] Certain information in this document 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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2. ESTABLISHMENT OF JOINT VENTURE COMPANY

2.1. JVC Venue . As soon as practicable after the Effective Date, the Parties shall select the JVC Venue from Singapore and Malaysia based on the overall economic advantage offered by either jurisdiction and other relevant factors as the Parties may mutually deem appropriate. Promptly after the selection of the JVC Venue, the Parties agree to amend this Agreement to (i) specify the selection of the JVC Venue, (ii) make other changes to the extent necessary or appropriate to comply with Applicable Laws of the JVC Venue, (iii) specify the face value for the Shares; (iv) modify those tax-related provisions for the purpose of minimizing each Party’s tax liabilities arising from its activities under this Agreement to the extent legally permissible; and (v) take such other actions and complete such documentation as necessary or appropriate in connection with the incorporation of the JVC in the JVC Venue.

2.2. Business Scope . The JVC’s business scope shall be the development and commercialization of JVC Products in the Territory.

2.3. Establishment . Promptly after the Effective Date, Agila shall apply for and obtain all governmental approvals, licenses and permits necessary for the incorporation of the JVC and each Party’s investment therein (collectively, the “ Incorporation Permits ”). Pfenex shall reasonably cooperate with Agila in such activities, including by providing all documents in its possession that are necessary or reasonably useful for Agila’s performance of such activities. Agila shall keep Pfenex informed on the status of any Incorporation Permits. Reasonably in advance of the submission of any material filings or correspondences with applicable governmental authorities with respect to any Incorporation Permits, Agila shall provide a copy of such documents to Pfenex for its review and shall incorporate any reasonable comments and suggestions provided by Pfenex with respect thereto. Agila shall make available copies of any material filings or correspondence with applicable governmental authorities with respect to any Incorporation Permits promptly after such filings or correspondences have been submitted. All costs incurred by each Party under this Section 2.3 will be reimbursed by the JVC as pre-operations expenses after the initial capital contribution of the JVC is completed.

2.4. Completion . The establishment of the JVC shall be deemed completed upon the completion of the following:

2.4.1 The incorporation of the JVC and receipt of all Incorporation Permits;

2.4.2 The issuance of Shares to each Party, in accordance with Article 3 below; and

2.4.3 The appointment of the Directors, in accordance with Article 4 below.

2.5. Obligations of the Parties . Pfenex and Agila agree to participate as shareholders of and joint venture partners in the JVC and to exercise their respective voting rights and to cause the Directors respectively nominated or appointed by them to serve on the Board or committees of the JVC to vote at Board and committee meetings and otherwise in such manner as duly to perform,

 

[*] Certain information in this document 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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effectuate and implement the terms and conditions of this Agreement and to prevent the taking by the JVC or by them or by any of them or by any Third Party of any action contrary to, or inconsistent with, the terms of this Agreement.

2.6. Corporate Name . The JVC shall be incorporated with such name as may be mutually agreed by the Parties.

2.7. Registered Office . The Parties agree that the registered office of the JVC shall initially be located at a mutually-agreed city within the JVC Venue. Any change in the location of the registered office shall be subject to the mutual agreement of the Parties.

 

3. CAPITAL CONTRIBUTIONS.

3.1. Ownership . Pfenex and Agila shall each make initial capital and other contributions of rights and assets necessary to establish the JVC in accordance with this Agreement and Applicable Laws, including any applicable pricing guidelines in the JVC Venue. In consideration for such contributions, Pfenex shall be issued and own forty-nine percent (49%) of the Shares, and Agila shall be issued and own fifty-one percent (51%) of the Shares (such percentages, the Parties’ respective “ Ownership Interest ”).

3.2. Issuance of Shares . Promptly after the incorporation of the JVC, the Parties shall subscribe to the Shares in the manner provided in Section 3.1 and for that purpose, take all necessary steps and credit the respective Share subscription monies to an account designated by the JVC for this purpose. Upon receipt of the Share subscription monies into the designated account of the JVC, the JVC shall allot and issue the Shares to the Parties, in proportion to their Ownership Interests, and deliver to the Parties one or more original share certificates and other instruments, if any, evidencing the subscription of the aforesaid Shares. The Parties shall ensure that the JVC takes all corporate steps necessary for issuance of the Shares in the manner contemplated under Section 3.1, makes all necessary filings, pays all filing fees, stamp duty and other governmental fees, and takes all other steps required to be followed by the JVC under Applicable Laws to ensure that the Shares are validly issued and that the names of the Parties are reflected in the in the records of the JVC (including in the register of members of the JVC) as the registered owners of such Shares.

3.3. Capital Contributions . It is understood that prior to the inclusion of a JVC Product within the business scope of the JVC, the Parties will agree to a Plan and Budget (as defined in section 3.8 of the JDLA) for the development and commercialization of such JVC Product pursuant to the JDLA. Each such Plan and Budget will set forth a detailed development plan and the funding requirements for the continued development of such JVC Product during the first six (6)-month period following completion of the first Phase I Clinical Trial for such JVC Product pursuant to the JDLA, as well as a high level plan and budget to advance the applicable JVC Product through development to commercialization. Upon ratification of the Plan and Budget for a JVC Product by the Board (such date, the “ Ratification Date ”), each Party will contribute funding to the JVC to meet the requirements for the first six (6)-month period under such Plan and Budget in proportion to its Ownership Interest. It is understood that no development or commercialization activities (excluding the development activities conducted by the Parties pursuant to the JDLA) shall be initiated by or on behalf of the JVC prior to the ratification of a Plan and Budget for the applicable JVC Product by the Board.

 

[*] Certain information in this document 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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3.4. Future Funding Obligations . Each Party acknowledges that upon inclusion of a JVC Product within the scope of the JVC, the JVC should be adequately funded to initiate the Plan and Budget for such JVC Product during the following six (6)-month period. Furthermore, on each six (6)-month anniversary of the Ratification Date for a JVC Product, the JVC should be adequately funded to perform its activities in the following six (6)-month period as set forth in the applicable Semi-annual Plan and Budget. In the event any additional funding is required within any such six (6)-month period, the Operations Committee shall propose an amendment to the applicable Semi-annual Plan and Budget for the Board’s approval. Upon the Board’s approval of such amendment, each Party shall contribute any additional capital required by such amended Semi-annual Plan and Budget in accordance with their respective Ownership Interests. Accordingly, each Party agrees to provide funding to the JVC in accordance with its obligations under each Plan and Budget and each Semi-annual Plan and Budget, and each Party further agrees that neither Party will be required under the terms of this Agreement to provide any further share capital, shareholder loans or other funding to the JVC unless otherwise mutually agreed by the Parties pursuant to the terms and conditions set forth in the applicable Plan and Budget or Semi-annual Plan and Budget.

 

4. BOARD OF DIRECTORS

4.1. Establishment . Promptly after the incorporation of the JVC, the Parties shall establish the board of directors of the JVC (the “ Board ”) to manage and oversee the activities of the JVC. The Board will be composed of four (4) directors (each, a “ Director ”), two (2) of which shall be designated by Pfenex and two (2) of which shall be designated by Agila. The Chairman of the Board (“ Chairman ”) shall be a senior member from the Appointing Party who will hold the position for six (6) months. Each Party (the “ Appointing Party ”) will appoint the Chairman on a rotating basis, with Agila as the first Appointing Party. It is understood that the appointment of Chairman is solely for administrative purposes. The Chairman shall not have a second or casting vote or any other authority or responsibility except as expressly set forth in this Agreement. If the Chairman is not present at any meeting of the Board, the Directors present may appoint anyone of the Board members present to act as Chairman for the purposes of such meeting. Each Party shall have the right to replace any Director appointed by such Party by providing written notice to the other Party. If a seat on the Board is vacated by the retirement, removal, resignation, illness, disability or death of any Director, the Party that originally appointed such Director shall appoint a successor to serve out such Director’s term. Each Party shall be solely responsible for the salary and other compensation to the Directors appointed by such Party, including all costs and expenses incurred by such Directors in attending any Board meetings.

4.2. Board Responsibilities . The role of the Board shall be:

4.2.1 to ratify each Plan and Budget;

4.2.2 to coordinate and oversee the transfer of each JVC Product to the JVC;

4.2.3 to review and approve each Semi-annual Plan and Budget and any amendment thereto;

 

[*] Certain information in this document 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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4.2.4 to manage and oversee the development and commercialization of each JVC Product (including manufacturing thereof), including all regulatory activities required or otherwise conducted in connection therewith;

4.2.5 to monitor each Clinical Trial conducted pursuant to a Plan and Budget or Semi-annual Plan and Budget;

4.2.6 to provide a forum for the Parties to exchange information with respect to matters pertaining to and status of the performance of each Plan and Budget and Semi-annual Plan and Budget; and

4.2.7 to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth hereunder or otherwise agreed in writing by the Parties.

4.3. Decision-making . Each Director will be entitled to one vote on all matters presented for a vote to the Board. All decisions to be made by the Board, except in case of matters set out in Exhibit 1 of this Agreement, will require the approval of the Board by majority vote with a quorum of the Directors present. A quorum shall exist if a majority of the total number of Directors is present, which majority must include at least one (1) Director designated by Agila and one (1) Director designated by Pfenex. In the event of a deadlock on any matter, such matter will be resolved in accordance with Section 17.10.

4.4. Board Meetings .

4.4.1 Meetings of the Board shall take place in accordance with Applicable Laws. A meeting of the Board shall be held at least once in every calendar quarter and at least four meetings shall be held in every calendar year. Board meetings may be conducted physically or by such other methods as may be permitted by Applicable Laws, including by video conference or teleconference. A meeting of the Board may be called at the request of either Party through its Meeting Coordinator by giving not less than five (5) Business Days’ advance notice in writing to all other Directors unless such notice is waived by an affirmative vote of at least one Director appointed by Agila and one Director appointed by Pfenex. Every such notice of a meeting of the Board shall be given in writing to every Director at his/her usual address, or such address as may have been expressly notified by such Director to the JVC.

4.4.2 Every notice of meeting shall specify the place or method, the day and hour of the meeting and shall be accompanied by a meeting agenda and supporting documents relevant to the consideration of each matter included in such meeting agenda. Notwithstanding the foregoing, with the written approval of at least one (1) Agila Director and one (1) Pfenex Director, the Board may consider any matter which was not earlier included in the agenda for the meeting.

4.4.3 Without limiting any quorum requirement mandated by Applicable Laws, no Board meeting shall be validly held unless at least one Agila Director and one Pfenex Director are present at such meeting. Each Party shall designate one of the Directors appointed by such Party as a coordinator for the Board meetings (each, a “ Meeting Coordinator ”). Each Party may change its designation of its Meeting Coordinator by written notice to the other Party. The Meeting Coordinator who has called for a Board meeting on behalf of its appointing Party shall (a) coordinate and prepare the agenda and ensure the orderly conduct of such Board meeting,

 

[*] Certain information in this document 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) attend such Board meeting, and (c) prepare and issue minutes of such Board meeting within ten (10) Business Days thereafter accurately reflecting the discussions and decisions of the Board at such meeting.

4.4.4 For clarity, the first Board meeting shall be convened as soon as practicable after the Completion Date, but in any event within thirty (30) days of the Completion Date. Notwithstanding anything to the contrary, at least two (2) months in advance of the anticipated date for the first Board meeting, the Parties shall discuss and agree on a meeting agenda setting forth all subject matters to be discussed and approved by the Board during the first Board meeting.

 

5. SHAREHOLDER’S MEETING.

5.1. General . An annual general meeting of the Shareholders shall be held within six (6) months following the end of each Financial Year of the JVC such that not more than fifteen (15) months should elapse, between one annual general meeting and the next annual general meeting of the Parties. The Board shall circulate the audited financial statements of the JVC for the Financial Year most recently ended prior to the date of the annual general meeting to the Shareholders at least thirty (30) days before the annual general meeting held to approve and adopt the audited financial statements. The Shareholders shall use all reasonable efforts to cause the annual general meeting of the Shareholders to be held on the same day and location as a regular meeting of the Board and each Shareholder shall authorize a Director appointed by such Shareholder, in writing prior to the applicable Shareholders’ meeting, as its representative for the Shareholder’s meeting and such representative shall be entitled to exercise all of the powers of such Shareholder on its behalf at such meeting, but shall not otherwise have or hold any economic or other ownership interest in the JVC. The Chairman shall preside as chairman of each general meeting of the Parties of the JVC. The Chairman shall call general meetings of the Shareholders of the JVC as directed by the Board and include as agenda items for meetings of the Shareholders items specified by the Board. The Shareholders may call special meetings of the Shareholders to the extent permitted by the Articles of Association of the JVC (the “ Articles of Association ”) and Applicable Laws.

5.2. Notice of Shareholders’ Meetings .

5.2.1 For each meeting of the Shareholders, written notice of the time and place of such meeting shall be given by or at the direction of the Chairman with at least twenty-one (21) days prior to such meeting, unless a shorter notice period is agreed to by the Shareholders in accordance with the Articles of Association.

5.2.2 Each notice of a meeting of the Shareholders shall contain, among other things, the date, time and venue of the proposed meeting of the Shareholders and also an agenda specifying, in reasonable detail, the matters to be acted upon at the relevant meeting and shall be accompanied by all appropriate supporting information. Such notice of every meeting shall be given in writing to the Shareholders at their usual address, or such address as may have been expressly notified by them to the JVC. The required notice to the Shareholders may be waived to the extent permitted by the Articles of Association and Applicable Laws.

5.2.3 No meeting of the Shareholders shall be considered to be validly constituted unless the proper notice as contemplated in this Section 5.2 has been served or waived to the extent permitted by the Articles of Association and Applicable Laws.

 

[*] Certain information in this document 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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5.3. Location of Shareholders’ Meetings . Meetings of the Shareholders shall be held in location(s) mutually agreed by the Parties. To the extent permitted by Applicable Laws, the Shareholders may participate in any meeting of the Shareholders through the use of telephones, video conference or similar communications equipment by means of which all individuals participating in the meeting can hear and speak to each other and such participation shall constitute presence in person at the meeting.

5.4. Quorum for Shareholders’ Meetings .

5.4.1 Without limiting any quorum requirement mandated by Applicable Laws, no meeting of the Shareholders’ shall be validly held unless such meeting is attended by two (2) Shareholder representatives present in person, of which one (1) shall be a duly authorized representative or proxy of Pfenex and one (1) shall be a duly authorized representative or proxy of Agila.

5.4.2 No meeting of the Shareholders shall vote or resolve any matter which is not specified on the agenda for that meeting, unless with the prior consent of the Shareholder(s) constitute a quorum at such meeting.

5.4.3 Each Shareholder shall use all reasonable efforts to ensure the existence of a quorum at any meeting of the Shareholders duly called by the Chairman or the Shareholders.

5.4.4 The Shareholders shall have voting rights as provided .in the Articles of Association and Applicable Laws.

5.5. Shareholder Reserved Matter . The Parties agree that no action shall be taken by the Board, nor shall the Parties request or permit the taking of any action by the Board, with respect to any matters set out in Exhibit 1 of this Agreement (each, a “ Shareholder Reserved Matter ”) unless such Shareholder Reserved Matter has been approved by both the Shareholders.

5.6. Written Resolutions . Subject to the Articles of Association and Applicable Laws, a resolution in writing signed by or on behalf of each of the Shareholders entitled to receive notice of a meeting of Shareholders shall be as valid and effective for all purposes as a resolution of Shareholders duly passed at a general meeting of the JVC duly convened, held and constituted provided that when a Shareholder has signed a resolution by fax, the original of the signed copy shall be deposited with the JVC in its registered office or such other office as the JVC may designate for this purpose from time to time by such Shareholder as soon as possible thereafter. Any such resolution may consist of several documents, provided that each such document is signed by one or more Shareholders.

5.7. Shareholders’ Expenses . All travel, accommodation and other incidental expenses of the Shareholder representatives for attending any meeting of the Shareholders in person (including expenses incurred in travelling to and from such meetings) shall be borne by the respective Shareholders.

 

[*] Certain information in this document 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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6. MANAGEMENT

6.1. Operations Committee .

6.1.1 Promptly after the Completion Date, the Board shall appoint an operations committee (which will consist of an equal number of representatives from both Agila and Pfenex) to carry out the day-to-day management and operations of the JVC (the “ Operations Committee ”). On a JVC Product-by-JVC Product basis, the Operations Committee will prepare and update at least semi-annually a proposed plan and budget for the development and/or commercialization activities to be carried out by the JVC during the following six (6)-month period for each JVC Product (each, a “ Semi-annual Plan and Budget ”), which shall be consistent with the applicable Plan and Budget agreed by the Parties under section 3.9 of the JDLA and ratified by the Board, and shall submit each Semi-annual Plan and Budget to the Board for approval. Each Semi-annual Plan and Budget, as approved by the Board, shall be followed by the JVC during the following six (6)-month period.

6.1.2 The Operations Committee shall be comprised of the following subcommittees (each will consist of an equal number of representatives from both Agila and Pfenex): (a) a preclinical, clinical and regulatory subcommittee to manage and make any day-to-day decisions necessary to implement any preclinical or clinical studies and regulatory activities set forth in each Plan and Budget and Semi-annual Plan and Budget; (b) a chemistry, manufacturing, and controls (CMC) subcommittee to manage and make all day-to-day decisions necessary to implement any manufacturing-related activities set forth in each Plan and Budget and Semi-annual Plan and Budget; (c) a commercialization subcommittee to (i) propose business/commercialization strategies and priorities with respect to the JVC Products for the review and approval of the Operations Committee and (ii) manage and make all day-to-day decisions with respect to the commercialization of each JVC Product in accordance with the applicable Semi-annual Plan and Budget, and (d) an intellectual property subcommittee to develop and implement the intellectual property strategy with respect to JVC Technology and manage the prosecution, maintenance and enforcement of patents and patent applications claiming any JVC Technology (each of (a)-(d), a “ Subcommittee ”).

6.2. Finance Committee . The Parties will appoint a finance committee (which will consist of an equal number of representatives from both Agila and Pfenex) to (i) help the Operations Committee to establish detailed budget in each Plan and Budget and Semi-annual Plan and Budget, (ii) establish accounting systems and procedures to accurately account costs and expenses incurred and revenues generated under each Plan and Budget and Semi-annual Plan and Budget and allocate profits and losses among the JVC Products; (iii) coordinate and conduct the accounting, reporting, reconciliation and other related financial matters of the JVC, (iv) advise and provide support to the Operations Committee and the Board with respect to financial, accounting, budgeting, financial reporting, and other issues that may arise in connection with any Plan and Budget or Semi-annual Plan and Budget, or activities thereunder, (v) provide periodic updates to the Board on financial matters relating to development and commercialization activities under this Agreement, and (vi) undertake and/or approve such other matters as are specifically provided for such committee under the Agreement, or otherwise by the Board (the “ Finance Committee ”). Each member of the Finance Committee shall have reasonable expertise in the areas of accounting, cost allocation, budgeting, and financial reporting in the pharmaceutical industry, and at least one member from each Party shall be an individual with relevant decision-making authority such that the Finance Committee is able to effectuate all of its decisions within the scope of its activities and responsibilities.

 

[*] Certain information in this document 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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6.3. Decision-making . Each Committee or Subcommittee shall be responsible for day-to-day implementation and operations of the activities under this Agreement for which it has or is otherwise assigned responsibility, provided that such implementation is not inconsistent with the express terms of this Agreement, the applicable Plan and Budget or Semi-annual Plan and Budget, and the decisions of the Board. Each Committee or Subcommittee shall operate by unanimous vote in all decisions, with each Party having one vote and with at least one representative from each Party participating in such vote. If, with respect to a matter that is subject to a Committee or Subcommittee’s decision-making authority, such Committee or Subcommittee cannot reach unanimity, the matter shall be referred to the Board for resolution in accordance with Section 4.3.

6.4. Costs and Expenses .

6.4.1 Each Party shall be solely responsible for the salary and other compensation to its representatives in the Operations Committee (and any Subcommittees thereof) and the Finance Committee, including all costs and expenses incurred by such representatives in attending any Committee or Subcommittee meetings.

6.4.2 All expenses arising out of any audit, tax liability or as required under the Applicable Laws shall be borne by the JVC, except if provided otherwise under this Agreement.

6.4.3 It is understood that the Parties do not anticipate that the JVC will have any employees. In the event the Shareholders approve the JVC hiring any employee(s) by the JVC pursuant to Section 5.5, then all expenses relating to salaries and other compensation payable to such employee(s) of the JVC shall be borne by the JVC and the terms of such payments shall be as set out in the applicable employment agreement or in any other document, executed between the JVC and each applicable employee.

 

7. BUSINESS OPERATIONS

7.1. Manufacturing of JVC Products

7.1.1 Promptly after the Completion Date, the JVC and Agila and/or its Affiliates shall negotiate in good faith a supply agreement(s) pursuant to which Agila and/or its Affiliates will manufacture and supply each JVC Product from the [*] Facility (or such other Facility (as defined in section 1.9 of the JDLA) as the Board may agree) for development and commercialization by the JVC (the “ Manufacturing Agreement(s) ”). Agila shall manufacture and supply the JVC Products to the JVC in compliance with the terms and conditions of the relevant Manufacturing Agreement. The Manufacturing Agreement(s) shall include provisions that address forecasting, ordering, supply failure, product warranty, regulatory defaults and other terms and conditions, each in accordance with the reasonable and customary terms for similar arrangements in the pharmaceutical industry; provided that the supply price of JVC Products shall be subject to Section 7.1.2.

7.1.2 The Parties agree that, pursuant to the Manufacturing Agreements, (a) Agila shall manufacture and supply the JVC’s requirements of all JVC Products for conducting

 

[*] Certain information in this document 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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Clinical Trial(s) at a transfer price equal to [*], and (b) Agila shall supply the JVC’s requirements of all JVC Products for commercial sale at a price to be mutually agreed between Agila and the JVC; provided that in no event shall such commercial supply price exceed [*] plus [*] percent (*%) (the “ Supply Price ”) with respect to each JVC Product. The Parties acknowledge and agree that prior to and during the term of the Manufacturing Agreement, the JVC shall solicit price quotes for each JVC Product from Acceptable Third Party Suppliers, in order to benchmark Agila’s Supply Prices to the JVC. If the Supply Price offered by Agila for such JVC Product exceeds the best price available from any such Acceptable Third Party Supplier, adjusted for short-term opportunistic offers, Agila will use its best efforts to match such price. In the event that Agila cannot match such price, Agila shall provide such assistance as is reasonably necessary to enable such Acceptable Third Party Supplier to manufacture such JVC Product for the JVC, including by providing any necessary licenses or technology transfer. All costs including regulatory costs of site transfer incurred by the Parties in connection with a transfer of manufacturing of any JVC Product from Agila to an Acceptable Third Party Supplier pursuant to this Section 7.1.2 shall be borne by the JVC.

7.1.3 The Parties acknowledge and agree that simultaneously with the entry into the Manufacturing Agreement, the JVC and Agila shall enter into a quality agreement which sets out the policies, procedures, and standards by which the JVC and Agila will coordinate and implement their operational and quality assurance activities and regulatory compliance objectives with respect to the applicable JVC Product(s) (the “ Quality Agreement ”).

7.1.4 The terms and conditions of the Manufacturing Agreement and the Quality Agreement and the execution thereof shall be subject to the Board’s approval.

7.1.5 The Parties acknowledge and agree that the JVC shall contemplate secondary manufacturing strategies for the JVC Products, particularly in markets where domestic manufacturing is required or as reasonably necessary to avoid any supply failure.

7.2. Other Services by Parent Companies . During the term of this Agreement, the JVC may request provision of certain services relating to the development and/or commercialization of one or more JVC Products from each Party on an as-needed basis. If the requested Party is willing to provide such requested services, then the relevant Party shall negotiate in good faith with the JVC, the applicable service agreement containing terms and conditions that are consistent with reasonable and customary terms for similar arrangements in the pharmaceutical industry; provided that the price for providing such services shall equal to the actual direct cost incurred by such Party in the performance of such services (or the provision of products or materials, as the case may be) plus the applicable taxes, or in the event actual direct cost cannot be reasonably determined, the JVC and such requested Party will agree on costs and rates to be charged plus the applicable taxes. The price charged by each Party to the JVC for the provision of services hereunder shall be reviewed annually and be adjusted as mutually agreed by the JVC and the applicable Party and in accordance with Applicable Laws.

7.3. Manufacturing Records and Audits . Agila shall maintain complete and accurate records of its manufacturing activities under the Manufacturing Agreement. Pfenex shall have the right to audit, during normal business hours upon reasonable advanced notice and not more than once per calendar year, the facilities in which Agila manufactures the JVC Products all records of

 

[*] Certain information in this document 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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Agila’s manufacturing activities under the Manufacturing Agreement to ensure compliance with the terms of the Manufacturing Agreement and Applicable Laws. The cost of any such audit shall be borne by the JVC.

7.4. JVC Responsibilities . Except as expressly provided herein, the Parties acknowledge and agree that the JVC (itself or through contractors engaged by the JVC in accordance with the applicable Plan and Budget or Semi-annual Plan and Budget or as otherwise approved by the Board) shall be responsible for the performance of any and all development and commercialization activities with respect to each JVC Product, including:

7.4.1 developing and submitting all Regulatory Filings and obtaining and maintaining all Regulatory Approvals (including Marketing Approvals), in each case as necessary to develop and commercialize the JVC Products throughout the Territory;

7.4.2 obtaining and overseeing supply of JVC Products for Clinical Trials and commercial sales in accordance with Section 6.1;

7.4.3 overseeing Clinical Trials of JVC Products;

7.4.4 submitting annual reports and completion reports on the Clinical Trials of JVC Products to the prescribed Regulatory Authority in accordance with Applicable Laws;

7.4.5 establishing commercialization strategies for each JVC Product; and

7.4.6 selling, marketing and distributing JVC Products throughout the Territory.

7.5. Regulatory Matters . All Regulatory Filings and Regulatory Approvals (including Marketing Approvals) necessary to develop and commercialize the JVC Products throughout the Territory shall be filed and held in the name of the JVC. Each Party may participate in any scheduled meetings between the JVC and Regulatory Authorities concerning material regulatory matters relating to the JVC Products (including via conference call or videoconference), and will have the right to receive copies of all material regulatory correspondence between the JVC and Regulatory Authorities regarding the JVC Products. For clarity, the JVC shall own all the Regulatory Approvals (including Marketing Approvals), Regulatory Filings as well as all manufacturing and analytical records for the JVC Products, including all in-process and finished product records.

7.6. Cooperation . Each Party shall reasonably cooperate, at its own expense, with the JVC with respect to regulatory and legal compliance and quality control related to the development and commercialization of JVC Products, including by assisting the JVC to establish and implement, through the Operating Committee and subject to Board approval, appropriate regulatory and legal compliance and quality control policies and procedures, and by implementing any compliance and quality control policies and procedures with respect to services provided by such Party to the JVC as are reasonably necessary to enable the JVC to comply with the policies and procedures established by the Board. Each Party shall and shall cause the JVC to perform any and all activities under this Agreement in accordance with all Applicable Laws.

 

[*] Certain information in this document 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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7.7. Operational Audits . The Parties acknowledge and agree that the JVC shall permit one or more duly authorized representative of each Party, upon reasonable advance written notice to the JVC and during regular business hours, to access and audit the JVC’s (and any contractor of JVC involved in product manufacture, research and development) operations, the records and documents relating thereto to ensure compliance with the each Plan and Budget and Semi-annual Plan and Budget and Applicable Laws (including for purposes of conducting internal audits prior to an inspection by a Regulatory Authority) in connection with the development and commercialization of the JVC Products (including manufacturing thereof). The JVC shall record, respond and address all observations of the applicable Party. Each Party shall conduct the foregoing operational audit at its own costs.

 

8. FINANCE, AUDIT, DISTRIBUTIONS AND ALLOCATIONS OF PROFIT

8.1. Accounting System

8.1.1 The JVC shall adopt the internationally practiced accrual basis of accounting and the debit and credit method for book keeping, and shall, in accordance with the provisions of Applicable Laws, prepare complete, accurate and appropriate financial and accounting books and records satisfactory to the Board.

8.1.2 The accounting system and procedures to be adopted by the JVC shall be prepared by the Finance Committee, and shall be submitted to the Board for approval. If is required by Applicable Laws, then once approved by the Board, the accounting system and procedures shall be filed with the department of finance, the tax authorities or other governmental authorities having jurisdiction over the JVC.

8.1.3 The Finance Committee shall also prepare for internal reporting purposes of the Parties (i) certain financial data of the JVC (including sales, cost of sales, gross margin and operating income) on a quarterly basis and (ii) financial statements for the JVC within fifteen (15) days of the end of each calendar quarter.

8.2. Auditing . The JVC shall engage an accounting firm selected by the Board as its external auditor (the “ JVC Auditor ”) and to examine and verify the financial accounting books of the JVC on an annual basis. The results of the JVC Auditor’s examination shall be reported to the Board. The JVC shall submit to the Parties and to each Director the audited annual accounts within forty-five (45) days after the end of the Financial Year, together with the audit report of the JVC Auditor. In connection with the annual audit of the JVC, Agila shall provide to the JVC Auditor and the Board complete and accurate accounting records related to its performance of the manufacturing services to the JVC, which shall be prepared in accordance with the accounting principles it generally and consistently applies in its business operations. Agila further agrees to provide to the JVC Auditor and the Board a copy of all reports of any internal or external audit of Agila to the extent relating to the manufacturing services provided to the JVC. If the JVC Auditor and the Board discovers that Agila has overbilled the JVC for the manufacturing services, Agila shall reimburse the JVC such overbilled amount. In the event the overbilled amount exceeds the greater of One Hundred Thousand Dollars (U.S. $100,000) or ten percent (10%) of the total fees payable by the JVC to Agila during the period subject to such audit, then Agila shall also pay the JVC an interest at the lesser of (i) thirty (30) day U.S. dollar LIBOR rate effective for the date such

 

[*] Certain information in this document 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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overbilled amount was paid, as published by The Wall Street Journal, Internet Edition at www.wsj.com in the “Money Rates” column plus an additional two percent (2%), or (ii) the maximum rate permitted by Applicable Laws, calculated on the number of days since the JVC paid such overbilled amount. If the Parties cannot agree on whether Agila has overbilled the JVC for its manufacturing services or the overbilled amount, such dispute shall be resolved in accordance with the procedures set forth in Section 17.10. Notwithstanding the foregoing, billing differences arising out of a positive variance from standard costs assumed at the beginning of the year (as approved by the Board), and which are due to be adjusted at year end, will not be treated as overbilling even if it exceeds such [*] (U.S. $[*]) or [*] percent ([*]%).

8.3. Distribution and Allocation of Profits and Loss .

8.3.1 The JVC shall make all distributions of cash and other property to the Parties on a basis proportionate to Parties’ respective Ownership Interest.

8.3.2 Profits and losses will be allocated among the Parties in a manner consistent with their respective Ownership Interests and the requirements of Applicable Laws.

8.3.3 In the event of any liquidation, dissolution or winding up of the JVC, any distribution of cash or other property shall be made in accordance with the foregoing distribution provisions, after satisfaction of the debts and liabilities of the JVC and reservation of funds for the liquidation on an Ownership Interest basis.

 

9. SHARE TRANSFER

9.1. No Transfer . Neither Party may transfer its Shares in the JVC to any Person other than a wholly owned subsidiary of such Party, without the consent of the other Party; provided that each Party may transfer its Shares in the JVC in accordance with Section 9.2 below, or in connection with an assignment of this Agreement in accordance with Section 17.2, or otherwise to the other Party as set forth in Article 14. Any transfer or attempt to transfer Shares in violation of the foregoing shall be null and void ab initio , and the JVC shall (i) not register any such transfer of Shares; or (ii) cancel or rectify such transfer of Shares; or (iii) reject and reverse such erroneous transfer of Shares made or attempted, suo motu , without necessity of a Board decision and may institute proceedings for this purpose if required by Applicable Laws (as the case may be). In such circumstances, any transferee of Shares shall not be entitled to any rights under this Agreement.

9.2. Right of First Refusal and Tag-Along Right .

9.2.1 Subject to this Section 9.2, if either Party (“ Disposing Shareholder ”) proposes to transfer all or part of its Shares in the JVC to a Third Party (“ Proposed Transferee ”), the other Party (“ Non-Disposing Shareholder ”) shall have (i) a right of first refusal to purchase the Shares proposed to be transferred by the Disposing Shareholder (“ Right of First Refusal ”) or (ii) a right to tag along with the Disposing Shareholder in selling Shares to such Proposed Transferee (“ Tag-Along Right ”), each to be exercised in the manner set out below.

9.2.2 The Disposing Shareholder shall send a written notice (the “ Offer Notice ”) to the Non-Disposing Shareholder, which notice shall state (i) the number of Shares proposed to be transferred (the “ Offered Shares ”); (ii) the proposed consideration for the transfer (“ Offer Price ”);

 

[*] Certain information in this document 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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(iii) the name and address of the Proposed Transferee and the name and address of the beneficial owner(s) of the Proposed Transferee; and (iv) all other material terms and conditions subject to which the Offered Shares are proposed to be transferred.

9.2.3 Within a period of five (5) Business Days’ from the receipt of the Offer Notice (the “ Acceptance Period ”), the Non-Disposing Shareholders shall have the right to (i) exercise its Right of First Refusal to purchase all (but not less than all) of the Offered Shares at the Offer Price in accordance with Section 9.2.4 below by providing a written notice of its election to exercise its Right of First Refusal (the “ Acceptance Notice ”) to the Disposing Shareholder, or (ii) exercise its Tag-Along Right in accordance with Section 9.2.5 below through the delivery of a written notice of its election to exercise its Tag-Along Right (the “ Tag-Along Notice ”) to the Disposing Shareholder, which shall state the number and description of Shares that the Non-Disposing Shareholder wishes to sell to the Proposed Transferee at the Offer Price (“ Offered Tag Shares ”).

9.2.4 In the event that the Non-Disposing Shareholder provides the Acceptance Notice within the Acceptance Period, it shall have the right and obligation to purchase the Offered Shares at the Offer Price and it shall complete such purchase within a period of sixty (60) days from the date of Acceptance Notice. In the event the Non-Disposing Shareholder does not complete the transaction (including payment of consideration) within such sixty (60) day period, the Disposing Shareholder shall be free to sell the outstanding Offered Shares to the Proposed Transferee or any other Third Party which is not developing, manufacturing or commercializing, directly or indirectly, any product that directly competes with any JVC Product or Collaboration Product at a price not being less than the Offer Price within a period of one hundred and eighty (180) days from the expiry of the Acceptance Period. If the Offered Shares described in the Offer Notice are not transferred to any Third Party in accordance with this Section 9.2.4 within such one hundred and eighty (180) day period, the Offered Shares shall again be subject to all transfer restrictions as contained in this Article 9, and any new transfer will have to comply with this Section 9.2 (as applicable) before any Offered Shares held by the Disposing Shareholder may be transferred.

9.2.5 In the event that the Non-Disposing Shareholder provides the Tag-Along Notice within the Acceptance Period, the Disposing Shareholder will promptly notify the Proposed Transferee that the Non-Disposing Shareholder’s intent to sell Offered Tag Shares to the Proposed Transferee at the Offer Price and the other terms and conditions described in the Offer Notice. In the event the Proposed Transferee agrees to purchase Offered Tag Shares from the Non-Disposing Shareholder in addition to the Offered Shares from the Disposing Shareholder, the Disposing Shareholder shall promptly deliver to the Non-Disposing Shareholder a notice setting forth the delivery instructions and procedures required to effectuate the transfer of the Offered Tag Shares. In the event the Proposed Transferee does not agree to purchase any or all of the Offered Tag Shares, then each Party has the right to sell up to the percentage of the total Shares that such Proposed Transferee is willing to purchase in proportion to its Ownership Interest in the JVC. The Disposing Shareholder shall ensure that the Proposed Transferee or its nominee(s) purchase the applicable number of Offered Tag Shares from the Non-Disposing Shareholder at the same price and same terms and conditions offered to the Disposing Shareholder. If the Proposed Transferee or its nominee(s) does not complete the purchase of Offered Tag Shares as provided in this Section 9.2.5, then the Disposing Shareholder shall not transfer any of its Shares to the Proposed Transferee.

 

[*] Certain information in this document 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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9.2.6 In the event that the Non-Disposing Shareholder provides neither Acceptance Notice nor Tag-Along Notice during the Acceptance Period, the Disposing Shareholder shall be entitled to sell and transfer any or all the Offered Shares to the Proposed Transferee mentioned in the Offer Notice or any Third Party which is not developing, manufacturing or commercializing, directly or indirectly, any product that directly competes with any JVC Product or Collaboration Product on the terms and conditions substantially similar to those set out in the Offer Notice. If completion of such sale and transfer of Offered Shares does not take place within a period of one hundred and eighty (180) days following the expiry of the Acceptance Period, the Disposing Shareholder’s right to sell the Offered Shares shall lapse and the provisions of this Section 9.2 shall once again apply to the Disposing Shareholder’s Offered Shares.

9.2.7 The Parties acknowledge and agree any Third Party who has purchased any Shares under this Section 9.2 shall execute and deliver to each Party a Deed of Adherence in the form set forth in Exhibit 2 hereto.

 

10. RESTRICTIVE COVENANTS

10.1. Non-Compete . During the Term, each Party agrees that, except for its obligations hereunder, neither it nor any of its Affiliates shall develop, manufacture, supply or commercialize any JVC Product, or assist any Third Party to perform any such activities with respect to any JVC Product. Notwithstanding anything to the contrary in this Agreement, nothing in this Section 10.1 shall prohibit any Acquiring Entity from continuing, furthering or performing (i) any activities in which it was engaged prior to the effective date of the applicable transaction, pursuant to which the Acquiring Entity merges or consolidates with or acquires a Party, or a Party transfers to such Acquiring Entity all or substantially all of its assets to which this Agreement pertains, or (ii) any activities relating to products developed by such Acquiring Entity (or any Third Party) independent of (and without accessing or practicing) subject matter within the Pfenex Background Technology (in the case of an Acquiring Entity of Pfenex), the Agila Background Technology (in the case of an Acquiring Entity of Agila), or any JVC Technology.

10.2. Non-solicitation . It is agreed that neither Party nor any of their Affiliates shall approach, solicit or otherwise endeavour to entice away from the JVC any of its employees, agents, directors, consultant or advisor, or any of the employees seconded by the other Party as a result of or under the terms of this Agreement, whether or not such Person would commit a breach of contract of employment by leaving his employment.

 

11. INTELLECTUAL PROPERTY

11.1. Background Technology . Except for the limited licenses granted under Section 11.2 below, as between the Parties, each Party retains full right, title and interest in and to its respective Background Technology.

11.2. License Grant

11.2.1 License Grant by Pfenex . Pfenex hereby grants to JVC an exclusive (with respect to the JVC Products), non-transferable, worldwide, fully-paid up, royalty-free license under Pfenex’s Background Technology, together with all intellectual property rights therein, solely to the extent necessary for JVC to develop and commercialize the JVC Products in accordance with this Agreement.

 

[*] Certain information in this document 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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11.2.2 License Grant by Agila . Agila hereby grants to JVC an exclusive (with respect to the JVC Products), non-transferable, worldwide, fully-paid up, royalty-free license under Agila’s Background Technology, together with all intellectual property rights therein, solely to the extent necessary for JVC to develop and commercialize the JVC Products in accordance with this Agreement.

11.2.3 No Other Right . All rights and licenses granted under this Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted whether by implication, estoppel, reliance, or otherwise, by either Party to the JVC or the other Party.

11.3. JVC Technology . All right, title and interest to inventions and other subject matter (together with all intellectual property rights therein) conceived or created or first reduced to practice by or on behalf of the JVC under this Agreement and all Collaboration Technology assigned to JVC pursuant to section 10.6 of the JDLA (collectively, “ JVC Technology ”) shall be owned by JVC; provided that JVC Technology shall exclude all Pfenex Improvements, which will be the sole and exclusive property of Pfenex. To the extent permitted by Applicable Laws, each Party shall cause the JVC to assign to Pfenex all Pfenex Improvements and take such other reasonable actions at Pfenex’ request and expense to effectuate such assignment. As used herein, “ Pfenex Improvements ” means: all modifications and improvements to any Pfenex Expression Technology or Pfenex Materials and Deliverables and all inventions claiming the use of Pfenex Expression Technology that are not solely applicable to any JVC Product and all intellectual property rights pertaining to the foregoing. Prosecution, maintenance, and enforcement costs and control of all patents and patent applications within the JVC Technology will be conducted by the JVC.

11.4. Branding Trademarks . The JVC, through the Operations Committee, shall determine the appropriate trademark and trade name for each JVC Product. The Parties shall cause the JVC to follow all Applicable Laws and best practices regarding marking and usage of any trademark rights and domain names to protect the goodwill of the JVC. To the extent necessary or desirable for the development or commercialization of any JVC Product and consistent with Applicable Laws and industry standards for the applicable territory as determined by the Operations Committee and subject to Board’s approval, a Party’s trademark or trade name may be included in the trademark or trade name of any JVC Product in accordance with Applicable Laws and industry standards for the applicable territory, in which event such Party will grant the JVC a license to use such trademark or trade name (including name, logo or similar marks) of such Party solely for the development or commercialization of the applicable JVC Product in the applicable territory subject to terms and conditions mutually agreed between such Party and the JVC; provided, that if either Party ceases to be a Party of the JVC, unless otherwise provided for in a separate agreement, the JVC shall no longer be permitted to use such Party’s trademark or trade name (including name, logo or similar marks) in connection with the activities of the JVC.

11.5. Cooperation . The Parties shall at all times fully cooperate in order to reasonably implement the provisions of this Article 11. Such cooperation may include the execution of

 

[*] Certain information in this document 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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necessary legal documents, coordinating prosecution to avoid and/or mitigate any patentability issues, and the provision of any other assistance reasonably requested by the other Party or the JVC at such other Party’s or the JVC’s expenses, as applicable. Without limiting the foregoing, promptly after the Completion Date, each Party shall enter into a written agreement with the JVC to reflect the grant of licenses with respect to any Background Technology (including any trade mark license contemplated under Section 11.4) and assignment of intellectual property rights with respect to any Collaboration Technology or JVC Technology in consistence with section 10.6 of the JDLA and this Article 11.

 

12. CONFIDENTIALITY

12.1. Confidential Information . The Parties may from time to time disclose to each other Confidential Information pursuant to this Agreement or otherwise in connection with the JVC. “ Confidential Information ” means any information disclosed by one Party (the “ Disclosing Party ”) to the other Party (the “ Receiving Party ”) hereto, which (i) if disclosed in tangible form is marked “confidential” or with other similar designation to indicate its confidential or proprietary nature, (ii) if disclosed orally, is identified as confidential or proprietary by the Party disclosing such information at the time of its initial disclosure and is confirmed in writing as confidential or proprietary by the Disclosing Party within forty five (45) days after such initial disclosure, or (iii) is reasonably expected to be treated in a confidential manner based on the nature of such information and the circumstances of its disclosure. Without limiting the foregoing, the terms of this Agreement and all non-public information relating to the business or technology of the JVC (including information relating to the development and/or commercialization of any JVC Product) shall be deemed Confidential Information of both Parties. Notwithstanding the foregoing or anything herein to the contrary, the obligations of the Receiving Party under this Agreement shall not apply to any information that, in each case as demonstrated by written documentation: (a) was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure; (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement; (d) was subsequently lawfully disclosed to the Receiving Party by the Disclosing Party; or (e) was independently developed by the Receiving Party without use of or reference to any Confidential Information of the Disclosing Party.

12.2. Confidentiality . During the Term and for a period of five (5) years thereafter, each Party agrees to hold and maintain in strict confidence all Confidential Information of the other Party and neither Party shall use any Confidential Information of the other Party for any purpose except as permitted under this Agreement. Each Party further agrees not to disclose any Confidential Information of the other Party except to those employees and consultants who have a need to know and provided that each person to whom Confidential Information is disclosed agrees to be bound by terms regarding the disclosure and use of Confidential Information no less restrictive than those set forth in this Article 12.

12.3. Permitted disclosure . Each Party may use and disclose Confidential Information of the other Party as follows: (i) under appropriate confidentiality obligations substantially equivalent to those in this Agreement, in connection with the performance of its obligations or exercise of rights granted to such Party in this Agreement, (ii) to the extent such disclosure is reasonably

 

[*] Certain information in this document 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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necessary in filing for, prosecuting or maintenance of patents and other intellectual property rights (including applications therefor) in accordance with this Agreement, prosecuting or defending litigation, complying with applicable governmental regulations, filing for, conducting preclinical or clinical trials, obtaining and maintaining regulatory approvals, or otherwise required by Applicable Laws or the rules of a recognized stock exchange; provided, however, that if a Party is required by Applicable Laws or rules of stock exchange to make any such disclosure of the other Party’s Confidential Information it shall, to the extent legally permissible and practicable, give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of patent applications, shall use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed or limit the scope of the compelled disclosure (iii) in communication with existing and potential investors, collaborators, consultants, advisors (including financial advisors, lawyers and accountants) and others on a need to know basis, in each case under appropriate confidentiality obligations substantially equivalent to those of this Agreement.

12.4. Publicity Review .

12.4.1 General . Unless required by Applicable Laws, neither Party shall make any public disclosure in relation to this Agreement or any JVC Product without the prior written consent of the other Party. Without limiting the foregoing, each Party shall use good faith efforts to provide any disclosure required by Applicable Laws at least five (5) Business Days prior to such disclosure (to the extent practicable) for the other Party’s review and comment. Notwithstanding the foregoing, it is understood that the Parties will issue a joint press release to announce the execution of the JDLA and this Agreement as provided in section 9.4.1 of the JDLA. After the issuance of such public release, each Party may disclose to Third Parties the information contained in such press release without the need for further approval by the other Party.

12.4.2 Use of Names . Neither Party shall utilize the name or trademarks of the other Party or the JVC without the other Party’s prior written consent, provided that such use or disclosure shall be permitted if required by Applicable Laws and the Party making such use or disclosure consults with the other Party to the extent practicable not less than thirty (30) days prior to the use or disclosure.

 

13. REPRESENTATIONS AND WARRANTIES

13.1. Mutual Representations and Warranties . Each Party represents and warrants to the other Party that: (a) as of the Effective Date, it has the power and authority to enter into this Agreement and to perform its obligations hereunder and to grant to the other Party the rights granted to such other Party under this Agreement; (b) as of the Effective Date, it has obtained all necessary corporate and other approvals to enter into and execute this Agreement; (c) it is not, as of the Effective Date, a party to, nor will it enter into or assume during the Term, any contract or other obligation with a Third Party that would in any way limit the performance of its obligations under this Agreement; (d) this Agreement will, when executed, constitute valid and binding obligations on the Parties; and (e) entry into and performance by it of this Agreement will not (i) breach any provision of its bylaws or equivalent constitutional documents; or (ii) result in a breach of any Applicable Laws in its jurisdiction of incorporation or of any order, decree or judgment of any court or any Regulatory Authority, where any such breach would affect to a material extent its ability to enter into or perform its obligations under this Agreement.

 

[*] Certain information in this document 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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13.2. No Debarment . Each Party further represents and warrants that neither it, nor any of its Affiliates, nor any of their respective employees or contractors involved in the performance of this Agreement have been “debarred” by the FDA pursuant to 21 U.S.C. § 335a or subject to a similar sanction from any Regulatory Authority in any other jurisdiction, nor have debarment or similar proceedings against such Party, any of its Affiliates, or any of their respective employees or contractors involved in the performance of this Agreement been commenced. Each Party will promptly notify the other Party in writing if any such proceedings are commenced or if such Party, any of its Affiliates, or any of their respective employees or contractors involved in the performance of this Agreement are debarred or similarly sanctioned by any Regulatory Authority.

13.3. GMP Facility . Agila represents and warrants that prior to the Completion Date it will complete the construction and qualification of the [*] Facility (as defined in section 1.9 of the JDLA) with the capacity to supply all then-existing JVC Products in accordance with GMP and other Applicable Laws. It is understood that Agila’s failure to complete the construction and qualification of the [*] Facility with adequate capacity prior to the Completion Date will not be deemed a breach of this Agreement if: (i) Agila has used all reasonable efforts to achieve such goal and the delay is caused by circumstances beyond Agila’s reasonable control, and (ii) prior to completing the construction and qualification of the [*] Facility with adequate capacity, Agila will supply JVC’s requirements of all the JVC Products (including both clinical supply and commercial supply) in accordance with GMP and other Applicable Laws through any Affiliate(s) of Agila or any Acceptable Third Party Supplier(s) at the Interim Transfer Price. For purposes of the foregoing, the “ Interim Transfer Price ” shall mean [*] percent ([*]%) less than the average price quoted for the supply of the applicable JVC Product(s) quoted by three (3) independent Third Party manufacturers of international repute and having capabilities, to manufacture and supply such JVC Product(s) in accordance with GMP and other Applicable Laws (which Third Party manufacturers are chosen by the Board).

13.4. Disclaimer . EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTIES (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MAI’L’ER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES, INCLUDING ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.

13.5. Limitation of Liability . NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. HOWEVER, NOTHING IN THIS SECTION IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER ARTICLE15.

 

[*] Certain information in this document 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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14. TERM AND TERMINATION

14.1. Term . Unless otherwise terminated earlier pursuant to this Article 14, the term (“ Term ”) of this Agreement shall commence as of the Effective Date and shall remain in force and effect so long as there is at least one JVC Product under development or commercialization by the JVC under this Agreement, unless earlier terminated by a Party in accordance with this Agreement.

14.2. Termination for Failure to Launch . In the event the JVC fails to initiate the first commercial sale of any JVC Product under a Marketing Approval in the Territory within the timeframe set forth in the applicable Plan and Budget, either Party may terminate this Agreement with respect to such JVC Product by immediate written notice to the other Party. For clarity, such termination shall not affect any other JVC Product under this Agreement. It is understood that the first commercial sale of the first JVC Product under a Marketing Approval in the Territory shall occur within five (5) years after the Effective Date.

14.3. Termination for Convenience .

14.3.1 Offer . Beginning on the fifth anniversary of the Effective Date, a Party (the “ Offering Party ”) may offer to sell its entire equity interest in the registered capital of the JVC to the other Party (the “ Offered Party ”) by providing a written proposal referencing this Section 14.3 and setting forth in reasonable detail the financial terms and other terms and conditions of such sale, each in accordance with Applicable Laws (the “ Offer ”). To the extent required by Applicable Laws, the Offering Party shall obtain a valuation of the JVC pursuant to Section 14.5 at the Offering Party’s expense and propose the financial terms of the Offer based on such valuation. Within six (6) months of receiving such Offer, the Offered Party shall elect, by written notice to the Offering Party (“ Notice of Election ”), to either:

(a) accept the Offering Party’s offer to purchase the Offering Party’s entire equity interest in the registered capital of the JVC, in which event the Offered Party shall be bound to purchase, and the Offering Party shall be bound to sell, the Offering Party’s entire equity interest in the JVC pursuant to the terms and conditions (including financial terms) set forth in the Offer, or

(b) sell to the Offering Party the Offered Party’s entire equity interest in the registered capital of the JVC, in which event the Offering Party shall be bound to purchase, and the Offered Party shall be bound to sell, the Offered Party’s entire equity interest in the JVC pursuant to the terms and conditions (including financial terms) Set forth in the Offer, provided that the financial terms shall be adjusted based on the ratio of the Ownership Interest of the Offering Party and Offered Party. By way of example, if Pfenex offers to sell its entire equity interest in the JVC to Agila for [*] U.S. Dollars ([*]), Agila may elect to sell its entire equity interest in the JVC to Pfenex for [*] U.S. Dollars ([*]).

14.3.2 Completion of Purchase . The Parties shall in good faith complete the transaction contemplated under Section 14.3.1 as soon as practicable, but in no event later than six (6) months after the delivery of the Offered Party’s Notice of Election. The purchasing Party (the Offering Party or the Offered Party, as the case may be) shall pay the purchase price pursuant to the

 

[*] Certain information in this document 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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payment schedule set forth in the Offer (adjusted based on the ratio of the Ownership Interest if the Offered Party is the purchasing Party), and the other Party shall transfer all right, title and interest to such purchasing Party certificates representing all such equity interest in the JVC, free and clear of any liens, claims, charges or encumbrances duly endorsed for transfer and together with all necessary transfer documents (provided that the issuing Party may retain a security interest in the transferred shares until the shares are fully paid in accordance with the Offer).

14.4. Termination for Event of Default . Each Party shall have the right to terminate this Agreement in the event that the other Party experiences an Event of Default, upon providing written notice of its intent to terminate referencing this Section 14.4 to the other Party.

14.4.1 Event of Default . An “ Event of Default ” shall occur if (a) a Party breaches or fails to perform in any material respect any material obligation under this Agreement and at the end of the Cure Period therefor such breach or failure remains uncured, or (b) a Party (i) files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or trustee of such other Party or its assets, (ii) is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed or dismissed within ninety (90) days of its filing, or (iii) makes an assignment of substantially all of its assets for the benefit of its creditors (in each case of (a) or (b), such Party, the “ Defaulting Party ”). Without limiting the foregoing, the Parties acknowledge and agree that any material breach by Agila of the Manufacturing Agreement shall constitute an Event of Default by Agila under this Agreement.

14.4.2 Cure Period . Upon a Defaulting Party’s breach or failure to perform an obligation under this Agreement, the other Party (the “ Non-Defaulting Party ”) shall have the right to deliver to the Defaulting Party a notice of default (a “ Notice of Default ”). The Notice of Default shall set forth the nature of the Defaulting Party’s breach or failure of performance under this Agreement and a request for the Defaulting Party to cure such breach or failure within the Cure Period. If the Defaulting Party fails to cure the breach or failure within the Cure Period, the Non-Defaulting Party shall be entitled to exercise its Call Option as set forth in Section 14.4.3 or Put Option as set forth in Section 14.4.4. For purposes hereof, “ Cure Period ” means a period commencing on the date that the Notice of Default is provided by the Non-Defaulting Party and ending (a) thirty (30) days after Notice of Default is so provided, or (b) in the case of any obligation (other than an obligation to pay money) which cannot reasonably be cured within such thirty (30) day period, such longer period not to exceed one hundred twenty (120) days after the Notice of Default is so provided as is necessary to effect a cure of the Event of Default, so long as the Defaulting Party diligently attempts to effect a cure throughout such period.

 

[*] Certain information in this document 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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14.4.3 Call Option . Upon the occurrence of an Event of Default, the Non-Defaulting Party shall have an option to purchase the Defaulting Party’s entire equity interest in the registered capital of the JVC (the “ Call Option ”), and if the Non-Defaulting Party decides to exercise such Call Option at its own discretion by providing written notice to the Defaulting Party, the Defaulting Party must agree to sell all its equity interest in the JVC (the “ Call Option Sold Equity ”) to the Non-Defaulting Party (or its designated party) at a value determined pursuant to this Section 14.4.3 and shall cause its appointed Directors to vote in favor of the sale.

(a) If the Non-Defaulting Party decides to exercise its Call Option, it shall, by written notice (the “ Call Option Exercise Notice ”), propose to the Defaulting Party a price that in the Non-Defaulting Party’s reasonable opinion is the fair market value of the Call Option Sold Equity (the “ Call Option Purchase Price ”). If the Defaulting Party does not agree or does not reply within ten (10) Business Days of the Call Option Exercise Notice or it is otherwise required by Applicable Laws to obtain an outside valuation of the fair market value of the Call Option Sold Equity, the Parties shall commence an outside process for determining the Call Option Purchase Price in accordance with Section 14.5, at the Defaulting Party’s expense.

(b) Upon the receipt of the Purchase Price Certificate (as defined below) issued in accordance with Section 14.5, the Non-Defaulting Party shall be bound (subject to any necessary approvals of its shareholders in a general meeting and any regulatory approvals) to buy and the Defaulting Party shall be bound to sell the Call Option Sold Equity at [*] ([*]%) of the Valuation Price set out in the Purchase Price Certificate as issued in accordance with Section 14.5.

14.4.4 Put Option . Upon the occurrence of an Event of Default ,the Non-Defaulting Party shall have an option (“ Put Option ”) to sell to the Defaulting Party the Non-Defaulting Party’s entire equity interest in the registered capital of the JVC (“ Put Option Sold Equity ”), and if the Non-Defaulting Party decides to exercise its option at its own discretion by providing written notice to the Defaulting Party, the Defaulting Party must agree to purchase the Put Option Sold Equity at a value determined pursuant to this Section 14.4.4, and shall cause its appointed Directors to vote in favor of the sale.

(a) If the Non-Defaulting Party decides to exercise its Put Option, it shall, by Written notice (the “ Put Option Exercise Notice ”), propose to the Defaulting Party a price that in the Non-Defaulting Party’s reasonable opinion is the fair market value of the Put Option Sold Equity (the “ Put Option Purchase Price ”). If the Defaulting Party does not agree or does not reply within ten (10) Business Days of the Put Option Exercise Notice or it is otherwise required by Applicable Laws to obtain an outside valuation of the fair market value of the Put Option Sold Equity, the Parties shall commence an outside process for determining the Put Option Purchase Price in accordance with Section 14.5, at the Defaulting Party’s expense.

(b) Upon receipt by the Parties of the Purchase Price Certificate issued in accordance with Section 14.5, the Non-Defaulting Party shall be bound to sell, and the Defaulting Party shall be bound to purchase the Put Option Sold Equity at [*] percent ([*]%) of the Valuation Price set out in the Purchase Price Certificate issued in accordance with Section 14.5.

 

[*] Certain information in this document 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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14.5. Valuation and Procedure . Where a valuation is required to be carried out under this Agreement to determine the fair market value of any and all part of the equity interests of any Party in the JVC to be transferred under this Agreement, the Parties shall, and shall cause the JVC, to comply with the following provisions:

14.5.1 Within ten (10) Business Days upon a Party’s receipt of a written notice from the other Party to initiate a valuation pursuant to this Agreement; the Parties shall negotiate in good faith and select and retain an internationally recognized investment bank with relevant experience in the business of valuation of pharmaceutical business which is qualified under Applicable Laws (the “ Appraiser ”) to conduct a valuation of the fair market value of the relevant equity interest of the JVC in accordance with this Section 14.5 (the “ Valuation Price ”) and deliver its valuation report to the Parties within 30 days after its appointment. In its determination of the Valuation Price, the Appraisers shall, based on the purpose of the valuation, value the equity interest by applying internationally accepted actuarial methods for calculating the fair market value of the equity interest in a pharmaceutical company.

14.5.2 The Valuation Price as determined above shall be final and binding upon the Parties, and such Valuation Price shall be certified by the Appraiser (the “ Purchase Price Certificate ”). Each Party shall equally bear the fees and costs arising from such valuation (including the Appraiser’s fees).

14.6. Cross-termination . In the event the JDLA is terminated (not expired) pursuant to its terms prior to the Completion Date or the Ratification Date for the first JVC Product, this Agreement shall terminate automatically.

14.7. JVC Successor . In the event this Agreement is terminated under Section 14.3 or Section 14.4 (and the Non-Defaulting Party has exercised the Call Option or Put Option) or the JVC is otherwise sold to a Third Party, the Parties shall fully cooperate with each other to facilitate a smooth, orderly and prompt transition of the development, manufacturing and/or commercialization of the JVC Products to the Party purchasing the JVC or the Third Party purchasing the JVC (the “ JVC Successor ”), at the JVC Successor’s expense. In connection therewith, each Party shall grant the JVC Successor a license to such Party’s Background Technology and all intellectual property rights therein to the extent necessary for the JVC Successor to continue developing, manufacturing and commercializing the JVC Products in the same manner as the JVC would perform such activities under this Agreement.

14.8. Survival . Any termination or expiration of this Agreement shall be without prejudice to the accrued rights and obligations of the Parties. The provisions of Articles 1, 12, 14, 16 and 17 and Sections 8.2, 11.3, 11.4, 11.5, 13.4, 13.5 and 15.2 shall survive such termination.

 

15. CONFLICTS

15.1. Articles of Association . All the provisions of this Agreement, to the extent relevant, shall be incorporated into the Articles of Association upon incorporation. Save to the extent prohibited by Applicable Laws, in the event of any inconsistency between the Articles of Association and the terms of this Agreement (on the other), the provisions of this Agreement shall prevail insofar as the contractual relationship between the Parties is concerned. The Parties further agree and undertake that in the event any inconsistency or ambiguity is discovered at any point of time in future between the Articles of Association and this Agreement, they shall endeavor, by exercising all voting and other rights and powers available to them, whether directly or indirectly, to remove the same by carrying out necessary amendment, modification and alteration in the Articles of Association thereby bringing the Articles of Association in conformity with this Agreement.

15.2. Applicable Laws . All the provisions of this Agreement would be subject to provisions of the Applicable Laws, if any, and to the extent applicable, and the Parties agree to take all such steps and make all changes hereto necessary to carry out the intention of the Parties as stated herein above in accordance with the Applicable Laws.

 

[*] Certain information in this document 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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16. INDEMNIFICATION

16.1. Pfenex . Pfenex shall indemnify, defend and hold harmless Agila, its directors, officers, employees, agents, successors and assigns from and against any liabilities, expenses or costs (including reasonable attorneys’ fees and court costs) (collectively “ Losses ”) arising out of any claim, complaint, suit, proceeding or cause of action against any of them by a Third Party resulting from: (a) the negligent or intentionally wrongful acts or omissions of Pfenex or its Affiliates or (b) any breach by Pfenex of its representations, warranties and covenants under this Agreement; in each case, subject to the requirements set forth in Section 16.4 below. Notwithstanding the foregoing, Pfenex shall have no obligations under this Section 16.1 for any liabilities, expenses or costs arising out of or relating to claims to the extent covered under Section 16.2 below.

16.2. Agila . Agila shall indemnify, defend and hold harmless Pfenex, its directors, officers, employees, agents, successors and assigns from and against all Losses arising out of any claim, complaint, suit, proceeding or cause of action against any of them by a Third Party resulting from: (a) the negligent or intentionally wrongful acts or omissions of Agila or its Affiliates or (b) any breach by Agila of any of its representations, warranties and covenants under this Agreement; in each case, subject to the requirements set forth in Section 16.4 below. Notwithstanding the foregoing, Agila shall have no obligations under this Section 16.2 for any liabilities, expenses or costs arising out of or relating to claims to the extent covered under Section 16.1 above.

16.3. Other Liabilities . Agila and Pfenex shall share at 51:49 ratio all Losses incurred by either Party, its directors, officers, employees, agents, successors and assigns arising out of any claim, complaint, suit, proceeding or cause of action against either Party by a Third Party resulting from (i) any activities conducted by or on behalf of either Party under this Agreement or (ii) any activities conducted by or on behalf of the JVC under this Agreement; except to the extent such Losses resulting from: (a) the negligent or intentionally wrongful acts or omissions of either Party or its Affiliates or (b) any breach by either Party of any of its representations, warranties and covenants under this Agreement.

16.4. Indemnification Procedure . Any Party seeking indemnification under this Article 16 (the “ Indemnitee ”) shall: (a) promptly notify the indemnifying Party (the “ Indemnitor ”) of such claim; (b) provide the Indemnitor sole control over the defense or settlement thereof; and (c) at the Indemnitor’s request and expense, provide full information and reasonable assistance to Indemnitor with respect to such claims. Without limiting the foregoing, with respect to claims brought under Section 16.1 or 16.2 above, the Indemnitee, at its own expense, shall have the right to participate with counsel of its own choosing in the defense or settlement of any such claim. The indemnification under this Article 16 shall not apply to amounts paid in settlement of any claim if such settlement is effected without the consent of the Indemnitor.

 

[*] Certain information in this document 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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16.5. Insurance .

16.5.1 The Parties acknowledge and agree that the JVC shall maintain product liability insurance, Clinical Trial Insurance, commercial general liability insurance and other relevant Third Party insurance coverage at conditions reasonable and customary for the local market in order to protect the JVC, its Directors, and management team. The types of coverage, the value and the term of insurance for the JVC shall be discussed and decided by the Board in accordance with Applicable Laws and applicable industry standards.

16.5.2 Each Party will procure and maintain, at its own expense, insurance, with a financially sound and reputable insurer, reasonably sufficient to cover such Party’s activities and obligations under this Agreement with minimum coverage amounts customary for the activities of such Party hereunder in the jurisdiction(s) where such activities are performed. Each Party will furnish at the request of the other Party a certificate(s) reflecting relevant insurance coverage and limits. Each Party will name the other as an additional insured on the policies for the coverage required herein.

 

17. GENERAL PROVISIONS

17.1. Affiliates . Each Party may perform any obligations and exercise any rights hereunder through any of its Affiliates subject to such Party intimating to the other Party the identity of the Affiliate and providing documents evidencing that the Person is an Affiliate of the Party. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement will be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

17.2. Assignment . Each Party agrees that its rights and obligations under this Agreement may not be assigned or otherwise transferred to a Third Party without the prior written consent of the other Party hereto. Notwithstanding the foregoing, either Party may transfer or assign its rights and obligations under this Agreement to (a) an Affiliate, subject to the prior notice to the other Party and the assigning Party remaining responsible for such Affiliate’s performance or (b) a successor to all or substantially all of its business or assets relating to this Agreement whether by sale, merger, operation of law or otherwise, without the prior written consent of the other Party; provided that such assignee or transferee has agreed to be bound by the terms and conditions of this Agreement. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties hereto, their successors and assigns.

17.3. Severability . If any clause, provision, or Section of this Agreement attached hereto, shall, for any reason, be held illegal, invalid or unenforceable, the Parties shall negotiate in good faith and in accordance with reasonable standards of fair dealing, a valid, legal, and enforceable substitute provision or provisions that most nearly reflect the original intent of the Parties under this Agreement in a manner that is commensurate in magnitude and degree with the changes arising as a result of any such substitute provision or provisions. All other provisions in this Agreement shall remain in full force and effect and shall be construed in order to carry out the original intent of the Parties as nearly as possible (consistent with the necessary reallocation of benefits) and as if such invalid, illegal, or unenforceable provision had never been contained herein.

 

[*] Certain information in this document 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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17.4. Merger of Understandings; Amendment . This Agreement (including the Exhibits attached hereto) and the JDLA as referenced herein constitute the entire agreement between the Parties regarding the subject matter hereof, and all prior negotiations and understandings between the Parties (except for the JDLA as referenced herein) regarding the subject matter hereof are deemed to be merged into this Agreement. No agreement or understanding varying or extending this Agreement or waiver of any right hereunder shall be binding upon either Party hereto, unless set forth in a writing which specifically refers to the Agreement signed by duly authorized officers or representatives of the respective Parties, and the provisions hereof not specifically amended thereby shall remain in full force and effect.

17.5. Waiver . Any waiver of the terms and conditions hereof must be explicitly in writing and executed by a duly authorized officer of the Party waiving compliance. The waiver by either of the Parties of any breach of any provision hereof by the other shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself. The delay or failure of any Party at any time to require performance of any provision of this Agreement shall in no manner affect such Party’s rights at a later time to enforce the same.

17.6. Notices . Any notice, report or other communication required or permitted to be given by either Party under this Agreement shall be given in writing and may be delivered by hand, reputable international 3- or 4-day courier service or by mailing, if mailed by registered or certified mail, postage prepaid and return receipt requested (or the international equivalent), or by email or fax (with printed confirmation of transmission and with confirmation copy forwarded by reputable international 3- or 4-day courier service), addressed to each Party as follows. Such information may be updated by a Party upon written notice to the other Party. A notice shall be deemed delivered upon receipt, unless the notice is received on a day other than a Business Day in the jurisdiction of the recipient or after 5:30 p.m. at the location of delivery, in which case delivery shall be deemed to be the next Business Day after receipt (as determined in the jurisdiction of recipient).

 

For Pfenex:      Pfenex Inc.
     10790 Roselle Street
     San Diego, CA 92121
     Attn: Patrick Lucy
     Fax: +1 978 887-4972
     Email: PKL@Pfenex.com
For Agila:      Agila Biotech Private Limited
     Strides House, Bilekehalli
     Bannerghatta Road
     Bangalore-560076
     Attention: Legal Department
     Fax: 080 67840800
     Email: legal@stridesarco.com

 

[*] Certain information in this document 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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17.7. Force Majeure . Neither of the Parties shall be liable for any default or delay in performance of any obligation under this Agreement caused by any of the following: Act of God, war, terrorism, riot, fire, explosion, accident, flood, sabotage, compliance with governmental requests, laws, regulations, orders or actions, national defense requirements or any other event beyond the reasonable control of such Party, or labor trouble, strike, lockout or injunction (provided that neither of the Parties shall be required to settle a labor dispute against its own best judgment). The Party invoking the provisions of this Section 17.7 shall give the other Party written notice and full particulars of such force majeure event. Both Pfenex and Agila shall use reasonable efforts to mitigate the effects of any force majeure on their respective part.

17.8. Relationship of the Parties . The relationship of Pfenex and Agila is strictly one of independent contractors and the Parties acknowledge that this Agreement does not create a partnership, or the like, between them. Pfenex and Agila shall always remain independent contractors in its performance of this Agreement. Neither Party shall have any authority to employ any individual as an employee or agent for or on behalf of the other Party to this Agreement for any purpose, and neither Party, nor any person performing any duties or engaging in any work at the request of such Party, shall be deemed to be an employee or agent of the other Party.

17.9. Choice of Law . All questions with respect to the construction of this Agreement and the rights and liabilities of the Parties hereto shall be determined in accordance with the laws of England and Wales, save for the provisions of Applicable Laws of the JVC Venue that shall apply mandatorily to any of the Parties or any transaction, matter or thing under this Agreement which shall prevail, without regard to any provisions of conflicts of law and shall not be governed by the United Nations Convention on Contracts for the International Sale of Goods.

17.10. Dispute Resolution .

17.10.1 General . If the Parties are unable to resolve any dispute or other matter arising out of or in connection with this Agreement, either Party may, by written notice to the other, have such dispute referred to the Chief Executive Officers of Parties for attempted resolution by good faith negotiations promptly after such notice is received. In such event, each Party shall cause its Chief Executive Officers to meet (face-to-face or by teleconference) and be available to attempt to resolve such issue. If the Parties should resolve such dispute or claim, a memorandum setting forth their agreement will be prepared and signed by both Parties if requested by either Party. The Parties shall cooperate in an effort to limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the dispute.

17.10.2 Arbitration . In the event that the Parties are unable to resolve any such matter subject to Section 17.10.1 within sixty (60) days from the date such dispute was referred to the Chief Executive Officers of the Parties, then either Party may initiate arbitration pursuant to this Section 17.10.2. Any arbitration under this Section 17.10.2 shall be conducted in English under the Arbitration Rules of the Singapore International Arbitration Centre (“ SIAC ”) in Singapore by a single arbitrator mutually selected by the Parties or otherwise selected in accordance with such rules. In such arbitration, the arbitrator shall select an independent expert with significant experience relating to the subject matter of such dispute to advise the arbitrator with respect to the subject matter of the dispute. If the Parties are unable to agree on an arbitrator, the arbitrator shall be selected by the chief executive of SIAC. The costs of such arbitration shall be shared equally by

 

[*] Certain information in this document 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 Parties, and each Party shall bear its own expenses in connection with the arbitration. The Parties shall use good faith efforts to complete arbitration under this Section 17.10.2 within sixty (60) days following the initiation of such arbitration. The arbitrator shall establish reasonable additional procedures to facilitate and complete such arbitration within such sixty (60) day period. Notwithstanding anything contained herein or the Arbitration Rules of the SIAC, the Parties agree that the Courts of Singapore shall have exclusive jurisdiction for seeking any equitable or interim relief or provisional remedy, including injunctive relief.

17.11. Provisions Contrary to Law . In performing this Agreement, the Parties shall comply with all Applicable Laws. Nothing in this Agreement shall be construed so as to require the violation of any law, and wherever there is any conflict between any provision of this Agreement and any law the law shall prevail, but in such event the affected provision of this Agreement shall be affected only to the extent necessary to bring it within the Applicable Laws.

17.12. Legal Fees . Except as otherwise provided herein, each Party shall bear its own legal fees incurred in connection with the transactions contemplated hereby or the enforcement hereof.

17.13. Headings . Headings herein are for convenience of reference only and shall in no way affect interpretation of this Agreement.

17.14. Counterparts . This Agreement may be executed in any number of counterparts with the same effect as if all Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.

17.15. Exhibits . The appended Exhibits and any modifications or amendments thereof form an integral part of this Agreement.

[The remainder of this page left blank intentionally; signature page follows immediately behind.]

 

[*] Certain information in this document 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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IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Agreement as of the Effective Date.

 

PFENEX INC.     AGILA BIOTECH PRIVATE LIMITED
By:  

/s/ Bertrand C. Liang

    By:  

/s/ Anand Iyer

Name:  

Bertrand C. Liang

    Name:  

Anand Iyer

Title:  

CEO

    Title:  

CEO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


EXHIBIT 1

SHAREHOLDER RESERVED MATTERS

 

A. Any changes to the capitalization of the JVC, including the issuance of additional shares of an existing class or the creation of additional classes of shares;

 

B. Any changes to the constituent documents of the JVC, including but not limited to, this Agreement and other agreements executed pursuant to the same;

 

C. Any equity financings;

 

D. Any dividends or distribution of profits to the Parties, other than distributions for taxes, that would have the effect of causing a material deterioration in the consolidated financial leverage of the JVC;

 

E. Material acquisitions or dispositions of assets outside the ordinary course of business or other extraordinary transactions;

 

F. Material changes to the accounting policies and/or tax election of the JVC;

 

G. The liquidation of the JVC;

 

H. Any merger or combination of the JVC with any other Person;

 

I. The JVC entering into any contract, other than as set forth in the applicable Plan and Budget or Semi-annual Plan and Budget;

 

J. Any capital expenditure, other than as set forth in the applicable Plan and Budget or Semi-annual Plan and Budget;

 

K. Any material capital investment in, or any material loan to, any Person outside of the ordinary course of business;

 

L. Any material change to the JVC’s business scope as set forth in this Agreement on the Effective Date;

 

M. Any contracts (and any amendments or modifications thereto) between any Party or its Affiliates and the JVC, and termination or extension thereof;

 

N. Hiring of any direct employee or consultant by the JVC; and

 

O. Grant of any license to any JVC Technology to any Third Party for any purpose other than manufacturing and/or commercializing any JVC Product.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


EXHIBIT 2

DEED OF ADHERENCE

THIS DEED OF ADHERENCE (this “Deed”) is entered into at [ ] this [ ] day of [ ], 20[ ]

BY:

[ ] <To specify the name and address of the new shareholder(s) purchasing shares in the Company>, a company incorporated and existing under the laws of [ ] and having its registered office at [ ] (hereinafter referred to as “the New Shareholder”);

IN FAVOUR OF

Pfenex Inc., a Delaware corporation with a principal place of business located at 10790 Roselle Street, San Diego, CA 92121 (hereinafter referred to as “ Pfenex ”);

Agila Biotech Private Limited, an India corporation with a principal place of business located at Strides House, Bilekahalli, Bannerghatta Road, Bangalore 560 076, India (hereinafter referred to as “ Agila ”).

<To specify the name and address of the JVC>

(to include any other Parties to the JV Agreement)

WHEREAS:

A. Pfenex and Agila (collectively, the “ JV Parties ”) entered into a Joint Venture Agreement dated [ ] (hereinafter referred to as the “ Agreement ”);

B. Pursuant to a [share purchase agreement] dated [ ] (the “ New Agreement ”), the New Shareholder has acquired [ ] Shares (the “ Securities ”) of the Company, from [ insert name] (the “ Selling Shareholder ”);

C. As contemplated in the Agreement, the New Shareholder is required to enter into this Deed.

NOW THE DEED WITNESSETH AND IT IS HEREBY AGREED BY AND BETWEEN THE PARTIES HERETO AS FOLLOWS:

 

  1. Definitions and Interpretation

1.1 Capitalised terms used but not defined in this Deed shall, unless the context otherwise requires, have the respective meaning ascribed thereto in the Agreement.

1.2 The provisions of Section 1.23 of the Agreement shall apply mutatis mutandis to this Deed and shall be deemed to be incorporated herein by reference as if the same were reproduced herein with references therein to this Agreement being references to this Deed.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


  2. Terms of Adherence

2.1 The New Shareholder hereby acknowledges that it has received, read and understood the Agreement and the Articles of Association of the JVC.

2.2 The New Shareholder hereby agrees, undertakes and covenants with the JV Parties that with effect from the date on which the New Shareholder has been registered as a member of the JVC, it shall adhere to, be bound by and act in accordance with the provisions .of the Agreement which were applicable to the Selling Shareholder and are capable of applying to the New Shareholder as if the New Shareholder were a Party to the Agreement in addition to or in place of the Selling Shareholder.

 

  3. Representations and Warranties

3.1 The New Shareholder hereby represents and warrants to the JV Parties that:

3.1.1 It is duly incorporated and validly existing as a corporation under the laws of its place of incorporation and has full power, capacity and authority to execute, deliver and perform this Deed and has taken all necessary actions (corporate, statutory or otherwise) to execute and authorise the execution, delivery and performance of this Deed; <To be modified appropriately if the New Shareholder is an individual>

3.1.2 This Deed upon execution and delivery by it shall constitute a legal and binding obligation on it enforceable against it in accordance with its terms;

3.1.3 The discharge by it of the obligations and liabilities under the Agreement and the performance by it of the acts and transactions contemplated hereby do not and will not (whether with or without the giving of notice or lapse of time or both), violate, conflict with, require any consent under or result in a breach of or default under:

(a) any law to which it is subject; or

(b) any term, condition, covenant, undertaking, agreement or other instrument to which it is a party or by which it is bound;

3.1.4 To the best of its information and knowledge, there are no legal, quasi-legal, administrative, arbitration, mediation, conciliation or other proceedings, claims, actions, governmental investigations, orders, judgments or decrees of any nature made, existing, threatened, anticipated or pending against it which may prejudicially affect its holding of the Securities or the due performance or enforceability of the Agreement or this Deed or any obligation, act, omission or transaction contemplated thereunder or hereunder.

 

  4. Incorporation of Provisions of the Agreement

This Deed is supplemental to the Agreement and the provisions of Section 17.9 (Choice of Law) and 17.10 (Dispute Resolution) the Agreement shall apply mutatis mutandis to this Deed and shall be deemed to be incorporated herein by reference as if the same were reproduced herein with references therein to this Agreement being references to this Deed.

 

[*] Certain information in this document 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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  5. Notices to the New Shareholder

The address of the New Shareholder for the purpose of receiving the notices under the Agreement is as under:

New Shareholder

 

Kind Attention    : [ ] <Insert details>

Address

   : [ ] <Insert details>
Facsimile    : [ ] <Insert details>

 

  6. Benefit of this Agreement

This Agreement is made for the benefit of the JV Parties. The New Shareholder agrees and acknowledges that either JV Party may enforce the terms of the Agreement against it and seek the remedies contained in the Agreement against it.

IN WITNESS WHEREOF, this Deed has been executed on the day and year first above written.

SIGNED, SEALED AND DELIVERED

  )

BY AND ON BEHALF OF

  )

the New Shareholder

  )

by [ ] (authorized signatory)

  )

[Position]

  )

[Witness]

  )

Common Seal of

  )

“New Shareholder”

  )

to be affixed hereunto if

  )

required under the Articles of Association

  )

 

[*] Certain information in this document 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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Exhibit 10.8

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].”

EXECUTION COPY

TECHNOLOGY LICENSING AGREEMENT

This Technology Licensing Agreement (“Agreement”) is effective as of the Effective Date and is by and between Dow Global Technologies Inc. and/or The Dow Chemical Company (hereinafter both are referred to as “Dow”), both Delaware corporations having their principal offices at either 2040 Dow Center, Midland, MI, 48674 USA or 2030 Dow Center, Midland, MI, 48674 USA and Pfenex Inc., a Delaware corporation (hereinafter “Pfenex”) having a principal place of business at 5501 Oberlin Drive, San Diego, CA.

RECITALS

WHEREAS, Dow owns the rights to a certain series of patents related to Pseudomonas fluorescens expression technology and made substantial patented and unpatented improvements to such technology, now generally known as “ Pf enex Expression Technology TM ”;

WHEREAS, Dow has certain rights to a certain series of patents related to RNA viruses;

WHEREAS, Dow has certain rights to a certain series of patents related to the use or transgenic plants for oral immunization of animals;

WHEREAS, Dow owns the rights to a certain series of patents related to production techniques for proteins;

WHEREAS, Dow has certain rights to a certain series of patents related to the ARC technology;

WHEREAS, Pfenex desires to take a license to such intellectual property as further defined below.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

CONFIDENTIAL - Do not share without permission

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EXECUTION COPY

 

ARTICLE 1 DEFINITIONS

1.01 Affiliates : “Affiliates” shall mean any entity that, directly or indirectly through one or more intermediates, controls, is controlled by or is under common control with either Dow or Pfenex, where “controls”, “controlled by”, and “is under common control” means ownership, directly or indirectly, of fifty percent (50%) or more of the voting equity interest in the entity or the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of that entity, whether through ownership or voting securities, by contract or otherwise.

1.02 ARC Products : “ARC Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the ARC Patents.

1.03 ARC Patents . “ARC Patents” shall mean the Patents owned or Controlled by Dow or its Affiliates as of the Effective Date, or at anytime during the Term, that are necessary or useful for the manufacture, use, or sale of ARC Products, including without limitation, the Gaertner patent as listed in Appendix D.

1.04 Assets: “Assets” shall mean collectively the RNA Virus Patents, the Oral Immunization Patents, the Production Techniques Patents, the ARC Patents and the rights granted to Pfenex under Section 2.01.05.

1.05 Control: “Control” in the context of intellectual property rights, shall mean rights to intellectual property sufficient to grant the applicable license or sublicense under this Agreement without violating the terms of any written agreement with any Third Party in effect as of the Effective Date. “Controlled” and “Controlling” shall have their correlative meanings.

1.06 Effective Date : “Effective Date” shall mean November 30, 2009.

1.07 Field : “Field” shall mean any and all applications for therapeutic purposes in humans for any and all indications, including, for the avoidance of doubt, vaccines. For

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

CONFIDENTIAL - Do not share without permission

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EXECUTION COPY

 

the purposes of this definition, “therapeutic purposes” shall mean, with respect to a particular indication, human diagnostics, prophylaxis, cure, reduction, mitigation, prevention, slowing or halting the progress of, or otherwise management of such indication.

1.08 Net Sales : “Net Sales” shall mean the sales revenues actually received by Pfenex from sales of the applicable Product (as set forth in Article 3) to Third Party customers, less: (a) Customary trade, quantity or cash discounts, credits and rebates (including, without limitation, credits, rebates and other discounts made or given with respect to Federal, state or foreign governmental programs (including, without limitation, Medicaid and Medicare) public or private hospitals and managed care entities or patient care organizations), and non-affiliated brokers’ or agents’ commissions actually allowed and taken; (b) Amounts repaid or credited by reason of rejection or return, including chargebacks, refunds or rebates (including expenses related to disposal); (c) Fees payable to purchasers, sales agents, distributors, group purchasing organizations or government agencies; (d) costs of insurance, packaging, storage and transportation from the place of manufacture to the customer’s premises; (e) provisions for uncollectible accounts determined in accordance with generally accepted accounting practices, consistently applied to all products of Pfenex; and/or (f) Taxes levied on and/or other governmental charges made as to production, import, export, sale, receipt, value-add, transportation, delivery, custom duties or use and paid by or on behalf of Pfenex for the RNA Virus Products, and less the sum of the following a) sales taxes, tariff duties and/or use taxes; b) direct, external out-of-pocket expenses incurred by Pfenex; and c) amounts rebated, credited or refunded on returns for the Oral Immunization Products.

1.09 Oral Immunization Products : “Oral Immunization Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the Oral Immunization Patents.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

CONFIDENTIAL - Do not share without permission

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1.10 Oral Immunization Patents . “Oral Immunization Patents” shall mean the Patents owned or Controlled by Dow or its Affiliates as of the Effective Date, or at anytime during the Term, that are necessary or useful for the manufacture, use, or sale of Oral Immunization Products, including without limitation, the Curtiss & Cardineau patents as listed in Appendix B.

1.11 Parties : “Parties” shall mean collectively Pfenex and Dow.

1.12 Party : “Party” shall mean either Pfenex or Dow as the case may be.

1.13 Patents : “Patents” shall have the meaning set forth in the Technology Assignment Agreement.

1.14 Product(s) : “Product” shall mean individually the RNA Virus Products, the Oral Immunization Products, the Production Techniques Products or the ARC Products, and “Products” shall mean collectively the RNA Virus Products, the Oral Immunization Products, the Production Techniques Products and the ARC Products.

1.15 Production Techniques Products : “Production Techniques Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the Production Techniques Patents.

1.16 Production Techniques Patents . “Production Techniques Patents” shall mean the Patents owned or Controlled by Dow or its Affiliates as of the Effective Date, or at anytime during the Term, that are necessary or useful for the manufacture, use, or sale of Production Techniques Products, including without limitation, the patents related to production techniques for various proteins as listed in Appendix C.

 

[*] Certain information in this document 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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1.17 RNA Virus Products : “RNA Virus Products” shall mean any product or part of a product, the making, using, importing or selling of which, absent the license set forth in Section 2.01, infringes a Valid Claim within the RNA Virus Patents.

1.18 RNA Virus Patents . “RNA Virus Patents” shall mean the Patents owned or Controlled by Dow or its Affiliates as of the Effective Date, or at anytime during the Term, that are necessary or useful for the manufacture, use, or sale of RNA Virus Products, including without limitation, the Ahlquist patents as listed in Appendix A.

1.19 Third Party : “Third Party” shall mean any person, organization, firm, corporation, partnership or entity other than Pfenex, Dow and their respective Affiliates.

1.20 Valid Claim : “Valid Claim” shall mean a claim of an issued, unexpired Patent within the RNA Virus Patents, the Oral Immunization Patents, the Production Techniques Patents or the ARC Patents, as the case may be, which: (a) has not been held unpatentable, invalid or unenforceable by a court or other government agency of competent jurisdiction in a decision from which no appeal can or has been taken; and (b) which has not been admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise.

1.21 All capitalized terms used in this Agreement that are not explicitly defined herein shall have the corresponding meanings set forth in the Contribution, Assignment and Assumption Agreement, the Technology Assignment Agreement or the Grant-Back and Technology License Agreement.

 

ARTICLE 2 TRANSFER AND LICENSE OF ASSETS

2.01 Grant to Pfenex

2.01.01 RNA Virus Patents: Dow hereby grants to Pfenex a worldwide royalty bearing license/sublicense, including the right to grant and authorize sublicenses in accordance with Section 2.02, under the RNA Virus Patents to: (a) make, have made, use, sell, offer for sale and import RNA Virus Products;

 

[*] Certain information in this document 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) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above; and (c) otherwise exploit the RNA Virus Patents. The license/sublicense set forth in this Section 2.01.01 shall be exclusive (even as to Dow) in the Field.

2.01.02 Oral Immunization Patents: Dow hereby grants to Pfenex a worldwide royalty bearing license/sublicense, including the right to grant and authorize sublicenses in accordance with Section 2.02, under the Oral Immunization Patents to: (a) make, have made, use, sell, offer for sale and import Oral Immunization Products; (b) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above; and (c) otherwise exploit the Oral Immunization Patents. The license/sublicense set forth in this Section 2.01.02 shall be exclusive (even as to Dow) in the Field.

2.01.03 Production Techniques Patents: Dow hereby grants to Pfenex a worldwide fully paid up, non-exclusive royalty-free license in the Field, including the right to grant and authorize sublicenses in accordance with Section 2.02, under the Production Techniques Patents to: (a) make, have made, use, sell, offer for sale and import Production Techniques Products; (b) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above; and (c) otherwise exploit the Production Techniques Patents.

2.01.04 ARC Patents: Dow hereby grants to Pfenex a worldwide fully paid up, royalty-free license, including the right to grant and authorize sublicenses in accordance with Section 2.02, under the ARC Patents to: (a) make, have made, use, sell, offer for sale and import ARC Products; (b) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above; and (c) otherwise exploit the ARC Patents. The license/sublicense set forth in this Section 2.01.04 shall be exclusive (even as to Dow) in the Field.

2.01.05 To the fullest extent Dow has or may receive rights under Section 4.7 of the License Agreement between DGTI and Diversa Corporation dated December 30, 2003 (“Diversa Agreement”), Dow hereby grants to Pfenex:

 

[*] Certain information in this document 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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2.01.05.01 A perpetual, worldwide, royalty-free, non-exclusive license or sublicense in the Field, as applicable, with the right to grant and authorize sublicenses in accordance with Section 2.02, under any DIVERSA patents or patent applications which have a priority date after December 19, 1997, and which are listed in the Diversa Agreement as may be amended, and which contain teachings or claims which both i) are directed to Pseudomonas organisms and ii) include information derived from the use of the TDCC Technology and/or Sequestered Information, in each case to: (a) make, have made, use, sell, offer for sale, import or otherwise exploit any product and (b) practice any method, process or procedure in connection with its exercise of the activities described in clause (a) above. This license shall not include DIVERSA Genes, DIVERSA intellectual property directed to the functional applications of the protein or the use of the Gene with any other organism.

2.01.05.02 A worldwide, royalty-free, immunity in the Field from suit under any DIVERSA patents as set forth in the Diversa Agreement directed to the use of the genus Pseudomonas as an expression system. This immunity from suit does not extend to DIVERSA Genes, DIVERSA intellectual property directed to the functional applications of the proteins or the use of the Gene with any genus other than Pseudomonas .

2.01.05.03 For the purposes of this Section 2.01.05 the terms “DIVERSA,” “TDCC Technology,” “Sequestered Information,” “DIVERSA Genes” and “Gene” shall have the meanings set forth in the Diversa Agreement.

2.01.05.04 Prior to, or shortly after the Closing Date, Dow shall use reasonable efforts to cause Dow AgroScience (“DAS”) to obtain from Diversa (or its successor-in-interest) sufficient rights to effectuate the grant of rights from Dow to Pfenex in Sections 2.01.05.01 and 2.01.05.02, in writing, signed by the authorized representatives of the applicable parties.

 

[*] Certain information in this document 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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2.02 Sublicensing Rights .

2.02.01 Extension of Licenses to Affiliates . Pfenex may extend the rights under the licenses granted in Section 2.01 to one (1) or more of its Affiliates; provided that Pfenex shall remain responsible for such Affiliate’s compliance with all obligations under this Agreement applicable to such Affiliate.

2.02.02 Sublicenses . Provided Pfenex has the right to grant further sublicenses or extend other rights under any Assets, Pfenex may grant and authorize sublicenses to Third Parties under the rights granted in Section 2.01 above. With respect to each sublicense granted by Pfenex to a Third Party, such sublicense shall include an explicit reference to this Agreement and shall not conflict with, and shall be subordinate to, the terms and conditions of this Agreement.

 

ARTICLE 3 Royalties

3.01: RNA Virus Patents: Subject to the terms and conditions of this Agreement, if Pfenex makes commercial sales of a RNA Virus Product, Pfenex shall pay Dow a running royalty of [*] of the Net Sales of such RNA Virus Product, wherein said royalties are due within 150 days of the end of each year in which such sale is made.

3.02 Oral Immunization Patents: If Pfenex makes commercial sales of an Oral Immunization Product, Pfenex shall pay Dow the following to the extent owed pursuant to the license agreement between Washington University and Agrigenetics dated December 30, 1996 (“Washington University ’96 Agreement”):

3.02.01 A minimum payment due December 31 st of each year of [*], such payment obligation commencing at the end of the first full year during which Pfenex has made such commercial sales of an Oral Immunization Product. The payments made by Pfenex to Dow under this Section 3.02.01 shall be creditable against the running royalty rate owed by Pfenex to Dow under Section 3.02.02.

3.02.02 A running royalty, which shall equal the lesser of: (A) [*] of the Net Sales of such Oral Immunization Products or (B) the royalty percentage of the Net Sales of such Oral Immunization Products owed by Dow to Washington University pursuant to the Washington University ’96 Agreement; wherein such royalty payments shall be due December 31 st of each year in which such sale is made.

 

[*] Certain information in this document 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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3.02.03 Within thirty (30) days after the end of each Contract Year prior to First Commercial Sale (“Contract Year” and “First Commercial Sale” shall have the meanings ascribed to them in the Washington University ’96 Agreement), an annual maintenance royalty of [*] which will be fully creditable against the royalties owed under Section 3.02.02. The payment obligation set forth in this section 3.02.03 shall commence in January 2010.

3.02.04 Third Party Payments . If Pfenex, its Affiliate or sublicensee pays amounts to a Third Party under any agreement to license or acquire intellectual property reasonably necessary for Pfenex, its Affiliate or sublicensee to develop or commercialize Products, then Pfenex may deduct [*] of such amounts from the amounts payable to Dow with respect to such Product pursuant to this Article 3; provided that, in no event shall the amounts due to Dow be so reduced to less than [*] of the amount that would otherwise be payable to Dow under this Article 3.02.02. For clarity, any amounts not offset in a particular period as a result of the cap in the preceding sentence shall be creditable in future periods. Subject to Section 3.02.02, in no event will the running royalty be less than [*].

3.03 Certain Terms .

3.03.01 Combination Product . In the event that a Product is sold in combination with another product, component or service for which no royalty would be due hereunder if sold separately, Net Sales from such combination product sales for purposes of calculating the amounts payable by Pfenex under this Article 3 shall be calculated by multiplying the Net Sales of the combination product by the fraction A/(A + B), where “A” is the average gross selling price during the previous calendar quarter of such Product sold separately and “B” is the gross selling price during the previous calendar quarter of the other product(s), component(s) or service(s). In the event that a substantial number of such separate sales of such Product or such other product(s),

 

[*] Certain information in this document 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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component(s) or services(s) were not made during the previous calendar quarter, then the Net Sales shall be as reasonably allocated by Pfenex between such Product and such other product(s), component(s) or service(s) based upon their relative importance and proprietary protection.

3.03.02 Single Royalty . No more than the one royalty shall be due under this Agreement, as set forth in Section 3.01, with respect to the sale of a particular unit of any Product. No royalty shall be payable under this Article 3 with respect to sales of Products among Pfenex, its Affiliates and its sublicensees for resale, nor shall a royalty be payable under this Article 3 with respect to any Products transferred for use in research or development, in clinical trials, in compassionate use programs, as donations to non-profit institutions or government agencies, or as promotional free samples or the like.

3.03.03 Royalty Term . Pfenex’s obligation to pay royalties under this Article 3 shall continue on a country-by-country and product-by-product basis until the expiration of the last Valid Claim in such country covering the sale of such Product. Thereafter, no further royalties shall be due with respect to such Product in such country.

3.03.05 Royalty Reports and Payments . Commencing with the first commercial sale of a Product by Pfenex hereunder, Pfenex shall provide to Dow a written report for each calendar quarter during the term of this Agreement, showing: (a) the gross sales of all Products sold by Pfenex during such calendar quarter and the calculation of Net Sales of Products from such gross sales; (b) a calculation of total royalties, payable in United States Dollars, which have accrued under this Agreement based upon such Net Sales of the Products; and (c) any reductions to or deductions from payments taken by Pfenex in accordance with this Agreement. If no royalties are due, Pfenex shall so report. Reports to be provided by Pfenex to Dow under this Section 3.03.05 shall be due sixty (60) days following the end of each calendar quarter.

 

[*] Certain information in this document 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 4 CONSIDERATION FOR THE ASSETS

4.01 In consideration for Dow’s license/sublicense under the Assets and other intellectual property hereunder, Pfenex shall issue to Dow shares of Series A-1 Preferred Stock of Pfenex as set forth in that certain Contribution, Assignment and Assumption Agreement by and between Dow and Pfenex of even date herewith.

 

ARTICLE 5 PFENEX REPRESENTATIONS AND WARRANTIES

5.01 Pfenex is a corporation duly organized and validly existing under the laws of the State of Delaware.

5.02 Pfenex has all the necessary power and authority to execute deliver and perform this Agreement, and no approvals or consents of anyone other than the signatories below are necessary in connection with the execution and delivery of this Agreement.

5.03 This Agreement has been duly executed and delivered by Pfenex and constitutes a legal, valid and binding obligation of Pfenex enforceable in accordance with its terms.

5.04 To the extent required of the licensee under the Washington University ’96 Agreement or under the Agreement between Agrigenetics and University of Wisconsin dated December 23, 1982 (“Wisconsin Agreement”), Pfenex shall provide activity reports to Washington University under the Washington University ’96 Agreement or to University of Wisconsin under the Wisconsin Agreement. Such activity reports shall comply with the format specified under the Washington University ’96 Agreement and shall include details about its activities and progress made, the status of any licensed products under development and/or planned for development, the tasks necessary to develop or complete the development and introduction of products to market, the estimated time schedules for product development, clinical trials, market testing, and regulatory approval, or the Wisconsin Agreement, as applicable. Upon delivery of such activity reports, Pfenex shall provide notice to Dow indicating that Pfenex has delivered the applicable activity report. Pfenex will use diligent efforts to bring a product to market using the RNA Virus Patents and the Oral Immunization Patents. Failure to use diligent efforts may result in a loss of license to the RNA Virus Patents and the Oral Immunization Patents.

 

[*] Certain information in this document 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 6 DOW REPRESENTATIONS AND WARRANTIES

6.01 The Dow Chemical Company and Dow Global Technologies Inc. are corporations duly organized and validly existing under the laws of the State of Delaware.

6.02 The Dow Chemical Company and Dow Global Technologies Inc. have all the necessary power and authority to execute deliver and perform this Agreement, and no approvals or consents of anyone (except certain additional Dow personnel) other than the signatories below are necessary in connection with the execution and delivery of this Agreement.

6.03 To the best of its knowledge as of the Effective Date, Dow has all rights to grant the licenses or sublicenses to the Assets, subject to Permitted Liens (as that term is defined in the Contribution, Assignment and Assumption Agreement and Schedule 1.17 therein) , and other performance promised to Pfenex under this Agreement and has good title to all information and materials which are included in the rights and intellectual property transferred to Pfenex pursuant to this Agreement, free and clear of any liens, judgments, encumbrances or adverse claims. For clarity, Dow will not, during the term of this Agreement, grant any rights to any Third Party that are inconsistent with the rights granted to Pfenex under this Agreement.

6.04 To the best of its knowledge as of the Effective Date, Dow is not aware of any claims, demands or actions alleging that any of the Assets licensed or sublicensed in this document are invalid or unenforceable. This provision does not include a representation or warrantee by Dow that any or all of the patent rights will grant or issue as valid patents.

6.05 To the best of its knowledge as of the Effective Date, Dow has not received any notice claiming that the Assets violate or infringe any intellectual property rights of any Third Party.

 

[*] Certain information in this document 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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6.06 With regards to Third Party Agreements:

6.06.01 As of the Effective Date, Exhibit 6.06.01 of this Agreement lists all the agreements between Dow and Third Parties pursuant to which Dow has in licensed, has gained Control of or acquired any Patents within the Assets (each, a “Third Party Agreement”);

6.06.02(i) Dow has previously provided to Pfenex a redacted (all material terms for the purposes of this Agreement have not been deleted) copy of each Third Party Agreement as the same is in effect as of the Effective Date, (ii) each Third Party Agreement is in full force and effect as of the Effective Date and Dow shall maintain each Third Party Agreement in full force and effect and enforce each Third Party Agreement to its fullest extent, in each case in accordance with its terms and conditions during the term of the Agreement subject to Section 5.04, (iii) as of the Effective Date, no notice of default or termination has been received or given by Dow under any Third Party Agreement, and (iv) during the term of this Agreement, Dow shall not amend or otherwise modify any Third Party Agreement to license out such technology in the Field, or allow any Third Party Agreement to be terminated, unless Pfenex fails to comply with the terms of such Third Party Agreement, without the prior consent of Pfenex; and

6.06.03 In the event of any notice of breach by Dow or its Affiliates, as applicable, of any Third Party Agreement the termination of which will or is likely to adversely affect Pfenex’s rights or obligations under this Agreement, Dow shall as promptly as reasonably practicable notify Pfenex in writing and Pfenex shall have the right, but not the obligation, to cure such breach on behalf of Dow or its Affiliates, as applicable. In the event of any notice of breach by the counterparty of any Third Party Agreement in a manner that will or is likely to adversely affect Pfenex’s rights or obligations under this Agreement, Dow shall immediately notify Pfenex.

6.07 Except for the express warranties in this article, Dow makes no representations or warranties, express or implied, either in fact or by operation of law, regarding without limitation, the validity or scope of any patent rights conveyed or including, without limitation, performance, merchantability, fitness for a particular purpose, or the non-infringement of third party intellectual property rights.

 

[*] Certain information in this document 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 7 PATENT PROSECUTION AND ENFORCEMENT

7.01 Patent Prosecution and Maintenance .

7.01.01 Control of Prosecution . As between the Parties, Dow shall control the Prosecution and Maintenance of all Assets. Notwithstanding the foregoing, Dow agrees to: (i) provide Pfenex with copies of all patent applications, continuations, divisionals, re-examinations, reissues, any and all office actions and requests for patent term extensions and the like including foreign counterparts thereof in existence as of the Effective Date within the Production Techniques Patents at least fifteen (15) business days before the due date for comment or with respect to foreign applications and office actions, as soon as reasonably practicable before the due date for comment; and (ii) consult in good faith with Pfenex regarding such matters with respect to the Field. Such copies may be provided electronically. For the purposes of this Section 7.01, “Prosecution and Maintenance” (including variations such as “Prosecute and Maintain”) shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as continuations, divisionals, re-examinations, reissues and requests for patent term extensions and the like with respect to such Patent, together with the conduct of interferences, oppositions and other similar proceedings with respect to a Patent.

7.01.02 In the event Dow decides to abandon an application or patent within the Production Techniques Patents that relates to the Field, Dow shall provide Pfenex fifteen (15) business days notice in which Pfenex will have the right to Prosecute and Maintain any such application or patent at its own cost. For the purposes of 7.01.02, “abandon” will include abandoning the Prosecution and Maintenance of a particular Patent without filing a divisional, continuation, continuation-in-part or foreign counterpart for such abandoned Patent.

7.01.03 Cooperation . Both Parties shall cooperate with each other in connection with all activities relating to the Prosecution and Maintenance of the Production Techniques Patents.

 

[*] Certain information in this document 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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7.02 Enforcement .

7.02.01 Notice . In the event that either Party reasonably believes that any Oral Immunization Patents, Production Techniques Patents, or ARC Patents are being infringed by a Third Party, or is subject to a declaratory judgment action arising from such infringement, in each case with respect to the manufacture, sale or use of a product for use within or outside the Field (an “Infringing Product”), such Party shall promptly notify the other Party.

7.02.02 Initiating Enforcement Actions . Pfenex and/or its Affiliates shall have the right (but not the obligation), at its own expense, to enforce the Oral Immunization Patents, Production Techniques Patents, or ARC Patents, or to defend any declaratory judgment action with respect to the Oral Immunization Patents, Production Techniques Patents, or ARC Patents (each, an “Enforcement Action”) in cases where the Infringing Product is marketed and sold for use within the Field. Pfenex shall provide notice to Dow in writing after taking any action to enforce, or threat to enforce, or defend any Enforcement Action and agrees to: (i) provide Dow with copies of and an opportunity to review and comment on all material communications, motions, filings, briefs, submissions and the like regarding the validity, enforcement (including ownership) and scope (including claim construction) of any of the Oral Immunization Patents, Production Techniques Patents, or ARC Patents, at Dow’s expense, at least fifteen (15) business days before the due date for filing or comment; and (ii) consider in good faith any comments provided by Dow regarding such matters. If Pfenex elects not to enforce or defend an Enforcement Action in a case where the Infringing Product is marketed and sold solely for use in, and is used solely in, the Field, within ninety (90) days after its receipt of a request from Dow to do so, Dow shall thereafter have the right, at its own expense, to either initiate and prosecute such action or to control the defense of such declaratory judgment action in its own name. Additionally, Dow shall have the right (but not the obligation), at its own expense, to enforce the Production Techniques Patents, or to defend any declaratory judgment action with respect thereto, in all other cases, including in cases where the Infringing Product is marketed and sold solely for use outside, and is used solely outside, the Field.

 

[*] Certain information in this document 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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7.02.03 Cooperation . Without limiting any rights of comment and review in Section 7.02.02, the Party initiating or defending any Enforcement Action pursuant to this Section 7.02 shall keep the other Party reasonably informed of the progress of any such Enforcement Action, and such other Party shall have the right to participate with counsel of its own choice and at its own expense. Notwithstanding the foregoing right to participate in any Enforcement Action, the Parties shall assist one another and cooperate in any such Enforcement Action, as reasonably requested by the Party initiating such Enforcement Action, at such Party’s expense.

 

ARTICLE 8 NOTICES

8.01 Any notice or other communication required or permitted to be given by either party under this Agreement shall be given in writing and shall be effective when delivered, if delivered by hand, reputable courier service, facsimile with confirmation of transmission, email with confirmation of receipt or five days after mailing if mailed by registered or certified mail, postage prepaid and return receipt requested, addressed to each party at the following addresses or such other address as may be designated by written notice by either Party:

If to Pfenex:

Chief Executive Officer

5501 Oberlin Drive

San Diego, CA 92121

Fax: 858-352-4602

Email: [To be designated by written notice to Dow]

If to Dow:

The Dow Chemical Company

9330 Zionsville Road

Indianapolis, IN 46268

Attention: General Patent Counsel

Fax: 317-337-4847

Email: jkabramson@dow.com and mdlyons@dow.com

 

[*] Certain information in this document 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 9 TERM AND TERMINATION

9.01 Term. This Agreement shall commence on the Effective Date and, unless terminated earlier as provided in this Article 9, shall continue in full force and effect until the last to expire of the Patents within the Assets. Upon the expiration (but not the earlier termination) of this Agreement in a given country in accordance with this Article 9, the licenses and rights granted by Dow to Pfenex under this Agreement will continue on a fully paid-up, royalty-free and irrevocable basis in such country.

9.02 Termination By Pfenex . Pfenex shall have the right to terminate this Agreement, in its entirety or on a Patent-by-Patent or a Product-by-Product basis, in its sole discretion, upon thirty (30) days prior written notice to Dow. From and after the effective date of such termination under this Section 9.02 with respect to a particular patent or product, such patent or product shall cease to be within the definition of the Patents within the Assets or Products, as applicable, for all purposes of this Agreement, and the rights and licenses granted by Dow to Pfenex under Article 2 shall terminate and all rights in the Assets shall revert to Dow with respect to such patent or product. Upon termination of this Agreement in its entirety under this Section 9.02, all rights and obligations of the Parties shall terminate, except as provided in Section 9.03 below. Notwithstanding the foregoing, Pfenex shall not terminate for a period of three (3) years following the Effective Date those licenses granted to Pfenex under this Agreement that are non-royalty bearing licenses. For clarity, Pfenex shall have the right to terminate such non-royalty bearing licenses at any time after such three (3) year period as set forth in this Article 9 and shall at any time be permitted to terminate any royalty-bearing license granted hereunder.

9.03 Effect of Expiration or Termination . Upon termination of this Agreement by Pfenex pursuant to Section 9.02, in its entirety or on a Patent-by-Patent or a Product-by-Product basis, the applicable rights and licenses granted by Dow to Pfenex under Article 2 shall terminate and the applicable rights in the Assets shall revert to Dow, provided, however, that:

9.03.01 Stock on Hand . Pfenex shall have the right to sell or otherwise dispose of all applicable Products in the process of manufacture, testing, in use or in stock; subject to the obligation of Pfenex to pay royalties to Dow for such Products in accordance with Article 3.

 

[*] Certain information in this document 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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9.03.02 Sublicenses . Any applicable sublicense granted by Pfenex under Section 2.02 prior to its receipt of the corresponding notice of such termination shall survive if the relevant sublicensee agrees in writing to be bound by the terms of this Agreement as such terms apply to such sublicensee (in which event, such sublicensee will be deemed a direct licensee of Dow); provided that, any such sublicensee shall only be responsible for any payments that become due as a result solely of such sublicensee’s activities after the effective date of any such termination and such sublicensee will be credited for any payments already paid by Pfenex prior to the effective date of any such termination as if such payment had been made by such sublicensee.

9.03.03 Survival of Certain Obligations . Subject to Section 9.03, expiration or termination of this Agreement for any reason shall not relieve either Party of any obligation accruing on or prior to such expiration or termination, or which is attributable to a period prior to such expiration or termination, nor preclude either Party from pursuing any rights and remedies it may have under this Agreement, or at law or in equity, which accrued or are based upon any event occurring prior to such expiration or termination. The provisions of Articles 1-3, 5-7, 9 and 10 (in each case as may be applicable in the event of termination on a Patent-by-Patent or a Product-by-Product basis) shall survive the expiration or termination of this Agreement for any reason.

 

ARTICLE 10 MISCELLANEOUS

10.01 Assignment: This Agreement and all rights herein may not be assigned by Pfenex without the prior written consent of Dow; provided that Pfenex may assign, without the prior written consent of Dow, all or part of this Agreement to an Affiliate or to an entity acquiring all or substantially all of the assets and business of a Pfenex to which this Agreement relates by merger, consolidation, public offering, or change of control, and such entity undertakes in writing all of the obligations and responsibilities of Pfenex under this Agreement. Dow may assign this Agreement, in whole or in part, without the written consent of Pfenex; provided that, prior to such assignment, the assignee agrees in writing to be bound by the terms and conditions of this Agreement. The terms and

 

[*] Certain information in this document 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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conditions of this Agreement shall be binding on and inure to the benefit of the permitted successors and assigns of the Parties. Except for assignments expressly permitted under this Section 10.01, any attempted assignment or transfer of this Agreement shall be null and void.

10.02 Severability : If any clause, provision, or section of this Agreement, shall, for any reason, be held illegal, invalid or unenforceable, the Parties shall negotiate in good faith and in accordance with reasonable standards of fair dealing, a valid, legal, and enforceable substitute provision or provisions that most nearly reflect the original intent of the Parties under this Agreement in a manner that is commensurate in magnitude and degree with the changes arising as a result of any such substitute provision or provisions. All other provisions in this Agreement shall remain in full force and effect and shall be construed in order to carry out the original intent of the Parties as nearly as possible (consistent with the necessary reallocation of benefits) and as if such invalid, illegal, or unenforceable provision had never been contained herein.

10.03 Merger of Understanding/Modification : This Agreement, the Transaction Agreements and all Schedules and Exhibits attached thereto constitute the entire Agreement between the Parties regarding the subject matter hereof and all prior negotiations and understandings between the Parties are deemed to be merged into this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of each of the Parties.

10.04 Force Majeure : Neither of the Parties shall be liable for any default or delay in performance of any obligation under this Agreement caused by any of the following: Act of God, war, terrorism, riot, fire, explosion, accident, flood, sabotage, compliance with governmental requests, laws, regulations, orders or actions, national defense requirements or any other event beyond the reasonable control of such Party; or labor trouble, strike, lockout or injunction (provided that neither of the Parties shall be required to settle a labor dispute against its own best judgment). The party invoking the provisions of this

 

[*] Certain information in this document 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 shall give the other Party written notice and full particulars of such force majeure event. Both Pfenex and Dow shall use reasonable business efforts to mitigate the effects of any force majeure on their respective part.

10.05 Relationship of the Parties : This Agreement does not create a joint venture, partnership, or the like, between the Parties. The Parties shall always remain independent contractors in its performance of this Agreement. No Party to this Agreement shall have any authority to employ any person as an employee or agent for or on behalf of the other party to this Agreement for any purpose, and no Party to this Agreement, nor any person performing any duties or engaging in any work at the request of such Party, shall be deemed to be an employee or agent of the other Party to this Agreement.

10.06 Choice of Law; Submission to Jurisdiction : All questions with respect to the construction of this Agreement and the rights and liabilities of the Parties hereto shall be determined in accordance with the laws of the State of New York applicable to business arrangements entered into and performed entirely within the State of New York. The Parties hereto irrevocably (a) submit to the exclusive personal jurisdiction of any state court or federal court in the State of New York in any suit, action or other legal proceeding relating to this Agreement; (b) agree that all claims in respect of any such suit, action or other legal proceeding may be heard and determined in, and enforced in and by, any such court; and (c) waive any objection that they may now or hereafter have to venue in any such court or that such court is an inconvenient forum.

10.07 Provisions Contrary to Law : In performing this Agreement, the Parties shall comply with all applicable laws and regulations. Nothing in this Agreement shall be construed so as to require the violation of any law, and wherever there is any conflict between any provision of this Agreement and any law the law shall prevail, but in such event the affected provision of this Agreement shall be affected only to the extent necessary to bring it within the applicable law.

 

[*] Certain information in this document 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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10.08 Remedies : Except as otherwise expressly stated in this Agreement, the rights and remedies of a party set forth herein with respect to failure of the other to comply with the terms of this Agreement (including, without limitation, rights of full termination of this Agreement) are not exclusive, the exercise thereof shall not constitute an election of remedies and the aggrieved party shall in all events be entitled to seek whatever additional remedies may be available in law or in equity.

10.09 Fees : Except as otherwise provided herein, each Party shall bear its own legal fees incurred in connection with the transactions contemplated hereby, provided, however, that if any Party to this Agreement seeks to enforce its rights under this Agreement by legal proceedings or otherwise, the non-prevailing Party shall pay all costs and expenses incurred by the prevailing party, including, without limitation, all reasonable attorneys’ fees.

10.10 Headings : Headings herein are for convenience of reference only and shall in no way affect interpretation of this Agreement.

10.11 Counterparts : This Agreement may be executed in any number of counterparts with the same effect as if all parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.

10.12 Appendices : The appended Appendices and Exhibits and any modifications or amendments thereof form an integral part of this Agreement.

10.13 Waiver : Neither Party may waive or release any of its rights or interests in this Agreement except in writing. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition. No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition or term.

 

[*] Certain information in this document 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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10.14 Confidentiality of the Agreement . Except as expressly permitted herein, this Agreement, including the terms set forth herein, shall be maintained in confidence by the Parties and shall not be provided or disclosed to Third Parties. Notwithstanding the foregoing, each Party shall have the right to disclose this Agreement, including the terms set forth herein, to its (i) tax advisors, accountants, legal counsel, investors, banks and financial sources and its advisors, or potential business partners or other Third Parties who are under an obligation of confidentiality, and (ii) in confidence, in connection with the sale of substantially all the business assets to which this Agreement relates, so long as, in the case of a disclosure under (i) or (ii) hereof, the person or entity to which disclosure is made is bound under confidentiality provisions that are reasonable and customary under the applicable circumstances. In addition, and notwithstanding anything to the contrary herein, Dow and Pfenex may disclose this Agreement, including the terms set forth herein, as required to comply with applicable law, regulations, court orders, or tax or securities filings (including any of the rules and regulations of a relevant stock exchange or other governing body, specifically including the Securities & Exchange Commission (SEC)).

10.15 Provisional Remedies : Nothing in this Agreement shall limit the right of either Party to seek to obtain in any court of competent jurisdiction any equitable or interim relief or provisional remedy, including injunctive relief, that may be necessary to protect the rights or property of that Party. Specifically, the Parties acknowledge a breach of this Agreement may result in irreparable harm to either Party, and either Party will be entitled to seek injunctive and other equitable relief to prevent any breach or the threat of any breach of this Agreement by the other Party without showing or proving actual damages. Notwithstanding, seeking or obtaining such equitable or interim relief or provisional remedy in a court shall not be deemed a waiver of the agreement to arbitrate. For clarity, any such equitable remedies shall be cumulative and not exclusive and are in addition to any other remedies that either Party may have under this Agreement or applicable law.

 

[*] Certain information in this document 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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10.16 Dispute Resolution : In the event any Dispute (as that term is defined in the Grant-Back and Technology License Agreement) arises between the Parties, the Parties shall resolve such Dispute utilizing the dispute resolution procedures set forth in Section 10.13 of the Grant-Back and Technology License Agreement; provided that, each reference to the term “Agreement” in such Section 10.13 of the Grant-Back and Technology License Agreement shall be deemed to be references to this Agreement; provided further that, the reference to “Section 10.14” shall be replaced with “Section 10.15” of this Agreement, and the reference to “Section 10.13” shall be replaced with “Section 10.16” of this Agreement.

[REMAINDER OF THIS PAGE LEFT BLANK INTENTIONALLY]

 

[*] Certain information in this document 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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IN WITNESS WHEREOF, the Parties hereto have understood, agreed to and caused this Agreement to be executed in duplicate originals by their duly authorized representatives as of the Effective Date.

 

THE DOW CHEMICAL COMPANY
By:  

/s/ Fernando Ruiz

Name:  

Fernando Ruiz

Title:  

Corporate Vice President and Treasurer

DOW GLOBAL TECHNOLOGIES INC.
By:  

/s/ Mark A. Whiteman

Name:  

Mark A. Whiteman

Title:  

President

PFENEX INC.
By:  

/s/ Albert Hansen

Name:  

Albert Hansen

Title:  

President

[Signature Page to Technology License Agreement]

 

[*] Certain information in this document 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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Appendix A

RNA Virus Patents:

 

Ahlquist   

MODIFIED PLUS STRAND RNA VIRUSES; (from Univ Wisconsin)

   2/14/1984    US5173410
Ahlquist   

Subgenomic promoter

   3/7/1985    US5466788
Ahlquist   

RNA transformation vector

   3/7/1985    US5500360
Ahlquist   

Hybrid RNA virus

   2/9/1987    US5602242
Ahlquist   

Hybrid RNA virus

   2/9/1987    US5627060
Ahlquist   

Plant tissue comprising a subgenomic promoter

   8/25/1994    US5633447
Ahlquist   

Subgenomic promoter

   8/25/1994    US5670353
Ahlquist   

Plasmid encoding hybrid RNA virus

   2/9/1987    US5804439
Ahlquist   

RNA transformation vector

   3/7/1985    US5846795

and any foreign counterpart thereof.

 

[*] Certain information in this document 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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Appendix B

Oral Immunization Patents:

 

Curtiss & Cardineau   

Oral Immunization By Transgenic Plants

      US5654184
Curtiss & Cardineau   

Oral Immunization By Transgenic Plants

      US5679880
Curtiss & Cardineau   

Oral Immunization By Transgenic Plants

      US5686079

and any foreign counterpart thereof.

 

[*] Certain information in this document 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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Appendix C

Production Techniques Patents:

 

62339A   

PCT

PCT

   OVER-EXPRESSION OF EXTREMOZYME GENES IN PSEUDOMONADS AND CLOSELY RELATED BACTERIA    2/13/2002     

WO2003068926 WO2003068948

PCT/US02/004294

   USA       10/504,505     
   Australia       2003215197     
   Brazil       PI0307630     
   Canada       2475926     
   China       03808240.3     
   EPO       03711011.1      [Validation in progress]
   India       1766/2004     
   Japan       2003-568041     
   Mexico       PA/A/04/007886     
61727A    USA    LOW-COST PRODUCTION OF PEPTIDES    5/22/2002     

US20050227321

PCT/US03/12407

   PCT           
   Australia       2003228637     
   Canada       2482995     
   China       03814541.3     
   EPO       03726398.5      [Validated in GB, FR, DE, NL, CH]
   India       261/2004     
   Japan       2003-586175     
   S. Korea       2004-7017047     
61957A    PCT    PROCESS FOR REMOVING WATER FROM AQUEOUS SOLUTIONS OF PROTEINS    2/27/2004      WO2005092915
   USA       10/590095     
   EPO       05713770.5      Validated in GB, DE, FR,
62644A    PCT    METHOD FOR THE EXTRACTION OF INTRACELLULAR PROTEINS FROM A FERMENTATION BROTH    2/27/2004     

WO2005087791

PCT/US05/005309

   USA       60/548403     
   EPO       05723333.0     
   USA       10/590185     
65217    USA    CONTINUOUS OSMOTIC SHOCK PROCESS FOR RELEASE OF PROTEINS FROM BACTERIA    1/12/2007      US Application No: 12/013042

 

[*] Certain information in this document 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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   AU       2008205632   
   CA       PCT/US08/000426   
   CH       PCT/US08/000426   
   EP       08724501.5   
   IN       PCT/US08/000426   
   JP       PCT/US08/000426   
   SINGAPORE       200904693-9   
   SOUTH KOREA       PCT/US08/000426   

 

[*] Certain information in this document 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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Appendix D

ARC Patent

US Patent No: 7,338,794 entitled “Amended recombinant cells for the production and delivery of gamma interferon as an antiviral agent, adjuvant and vaccine accelerant” and any foreign counterpart thereof.

 

[*] Certain information in this document 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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Exhibit 6.06.01

Third Party Agreements

1. License Agreement between Mycogen Corporation and The Dow Chemical Company dated January 1, 2001.

2. Agreement between Agrigenetics and University of Wisconsin dated December 23, 1982.

3. License Agreement between Washington University and Agrigenetics dated December 30, 1996.

4. ARC Technology License Agreement between Dow Global Technologies Incorporated and Dow AgroSciences LLC dated November 30, 2009.

5. Agreement between DAS and Dow granting rights under Section 4.7 of the Diversa Agreement.

 

[*] Certain information in this document 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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Exhibit 10.12

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].”

 

LOGO

SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT

 

SUBCONTRACTOR:   SUBCONTRACT #: P010022290
The Dow Chemical Company   MODIFICATION #: NA
ADDRESS: 2030 Dow Center Midland, MI 48674   DPAS RATING: NA
 

TYPE: FIRM FIXED PRICE

COMMERCIAL ITEMS (GOVERNMENT)

  VALUE: $336,800.00

INTRODUCTION

This Subcontract Agreement, effective September 11, 2009 is made between SCIENCE APPLICATIONS INTERNATIONAL CORPORATION (hereinafter known as “Buyer”), a Delaware corporation with principal offices in San Diego, California, and The Dow Chemical Company (hereinafter known as “Seller”), a Delaware corporation with principal offices in Midland, MI. The effort to be performed by Seller under this Subcontract will be part of Buyer’s Prime Contract # N01-AI-05421 which has been issued by National Institutes of Allergy and Infectious Diseases (NIAID). The work, defined in Attachment I (Statement of Work and Schedule) will be performed on a Firm Fixed-Price basis, in accordance with Schedule A (Specific Terms and Conditions), and any referenced documents listed in 17.0 Order of Precedence section of this agreement,

SCHEDULE A

SPECIFIC TERMS AND CONDITIONS

 

1.0 PRICE

The total firm fixed price for the work to be performed under this Subcontract is $336,800. This Subcontract is fully funded in the amount of $336,800 including profit.

 

1.1 DELIVERY

The goods and services required by this subcontract shall be delivered in accordance with the delivery schedule contained in this agreement. The time of delivery stated is of the essence of this Subcontract. The date specified for delivery is the required delivery date at Buyer’s plant, unless otherwise specifically noted herein. All items furnished under this subcontract shall be delivered FOB Destination, unless specified otherwise in writing by the Buyer’s contractual representative. Delivery shall not be deemed complete until the goods have been actually received and accepted by Buyer, notwithstanding delivery to any carrier, or until orders for services have been performed, received, and accepted by Buyer.

 

1.2 INSPECTION

All goods supplied and services performed pursuant hereto shall be subject to inspection and test by buyer and its agents and by its customers at all times and places, whether during or after manufacture as to goods, or performance as to services, and notwithstanding the terms of delivery or payment or, as to goods, that title has not yet passed to Buyer or to its customers. In the event that goods supplied are not performed in accordance with the specifications and instructions of Buyer, Buyer may require prompt correction thereof, or as to services, require that the services be rendered again at Seller’s expense. Buyer may terminate the subcontract for default if such defects exist and if Seller is unable or refuses to replace the goods or render the services again promptly.

 

[*] Certain information in this document 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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1.3 INVOICES

Invoices shall be prepared in duplicate and contain the following information; subcontract number, subproject number, Stage #. Invoices will be mailed to:

Science Applications International Corporation

Attention: Gina B. McGeehan

5202 Presidents Court, Suite 110

Frederick, Maryland 21703

Invoices shall clearly reference a unique invoice number on each invoice, and the date of the invoice. Invoices shall include the “Amount Previously Billed,” the “Amount of this Invoice,” and the “Total Amount Billed to Date.”

 

1.4 PAYMENT

For each Stage of work there will be two invoices each totaling 50 % of the price for each Stage of Work, an initial invoice upon commencement of the Stage and a final invoice upon acceptance of the final report for each Stage. Payment terms will be Net 45 days from date of invoice. Upon receipt of invoice Buyer shall within five (5) business days review the invoice and determine if the invoice is acceptable. If Buyer reasonable deems the invoice unacceptable Buyer shall contact Seller and Seller shall reissue a conforming invoice with a new date of invoice. If (1) Buyer does not pay on time or (2) Buyer’s financial responsibility becomes unsatisfactory (S&P rating below BBB- or Moody’s rating below Baa3) to Seller and Seller deems itself insecure , Seller may accelerate the due date and demand immediate payment on any outstanding invoice for Product, or may require cash payments or satisfactory security for future deliveries and for payment of all sums owed under this Agreement. Buyer agrees to pay all costs and expenses, including reasonable attorney’s fees, incurred by Seller in the collection of any sum payable by Buyer to Seller, or in the exercise of any remedy. Dow may charge Prime +2% on all overdue amounts.

 

1.5 WARRANTY

BUYER UNDERSTANDS AND ACKNOWLEDGES THAT MATERIAL IS EXPERIMENTAL AND BY PROVIDING MATERIAL SELLER MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ANY MATTER, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS OF THE MATERIAL PROVIDED HEREUNDER FOR ANY PARTICULAR PURPOSE OTHER THAN AS REQUIRED BY THE STATEMENT OF WORK OR THAT THE USE OF THE MATERIAL OR ANY PRODUCT OR PROCESS DERIVED OR PRODUCED THEREFROM WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR OTHER RIGHTS OF THIRD PARTIES. BUYER HEREBY AGREES THAT IN NO EVENT SHALL SELLER BE LIABLE FOR ANY DIRECT, INDIRECT OR CONSEQUENTIAL DAMAGES, RESULTING FROM ANY USE BY BUYER OF THE MATERIAL AND ALL DERIVATIVES THEREOF OUTSIDE OF THE SCOPE OF THIS AGREEMENT. ADDITIONALLY, THE SELLER WARRANTS THE PRICE CHARGED FOR THE GOODS AND/OR SERVICES PURCHASED PURSUANT HERETO SHALL BE NO HIGHER THAN SELLER’S CURRENT PRICE TO ANY OTHER CUSTOMER FOR THE SAME QUALITY AND QUANTITY OF SUCH GOODS OR SERVICES.

 

2.0 TECHNICAL AND CONTRACTUAL REPRESENTATIVES

The following authorized representatives are hereby designated for this Subcontract

 

SELLER:          BUYER:      
   TECHNICAL:   

Silvia Chang

      TECHNICAL:   

Steve Huang

   CONTRACTUAL:   

Patrick Lucy

      CONTRACTUAL:   

Gina B. McGeehan

 

2.1 CONTACTS

Contacts with Buyer that affect the subcontract prices, schedule, statement of work, and subcontract terms and conditions shall be made with the authorized contractual representative. No changes to this Subcontract shall be binding upon Buyer unless incorporated in a written modification to the Subcontract and signed by Buyer’s contractual representative.

 

[*] Certain information in this document 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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2.2 CHANGES

Buyer may, by reasonable written notice to Seller make changes within the general scope of this Order in any one or more of the following (a) drawings, designs or specifications; (b) quantity; (c) time or place of delivery; (d) method of shipment or packing; and (e) the quantity of Buyer furnished property. Upon Buyer’s written notice, Buyer may, for any reason, direct Seller to suspend, in whole or in part, delivery of goods or performance of services hereunder for such period of time as may be determined by Buyer in its sole discretion. If any such change or suspension causes a material increase or decrease in the cost of, or the lime required for the performance of any part of the Service under this Order, the parties will jointly determine an equitable adjustment in the Order price or delivery schedule, or both No such adjustment or any other modification of the terms of this Order will be allowed unless authorized by both parties by means of a written modification to the Order. Failure to agree to any adjustment shall be a dispute under the Disputes clause of this subcontract. However, Seller shall proceed with the work as changed without interruption and without awaiting settlement of any such claim.

 

3.0 DISCLOSURE

Seller shall not disclose information concerning work under this Subcontract to any third party, unless such disclosure is necessary for the performance of the subcontract effort. No news releases, public announcement, denial or confirmation of any part of the subject matter of this Subcontract or any phase of any program hereunder shall be made without prior written consent of Buyer. The restrictions of this paragraph shall continue in effect upon completion or termination of this Subcontract for such period of time as may be mutually agreed upon in writing by the parties. In the absence of a written established period, no disclosure is authorized. Failure to comply with the provisions of this Clause may be cause for termination of this subcontract

 

4.0 KEY PERSONNEL

 

(a) For purposes of this clause, Buyer and Seller define “Key Personnel” as those individuals who are mutually recognized as essential to the successful completion and execution of this Subcontract.

 

(b) Personnel designated as “Key Personnel” shall be assigned to the extent necessary for the timely completion of the task to which assigned. Any substitution or reassignment involving Seller’s “Key Personnel” assigned to this work shall be made only with persons of equal abilities and qualifications and is subject to prior approval of Buyer, in writing which will not be unreasonably withheld.

 

(c) Buyer reserves the right to request the removal and Seller shall endeavor to remove any individual assigned to this Subcontract if individual is deemed not qualified, or performs at an unacceptable level, or is requested by its client to do so. If Buyer is not satisfied with how the issue is resolved by Seller, Buyer may resolve the issue according to Section 10 of this Subcontract or alternatively may terminate this Subcontract according to Section 11 of this Subcontract at Buyers sole discretion.

 

(d) Seller’s Key Personnel are: Diane Retallack, Ph.D., Lawrence Chew, Ph.D. and Jeffrey Allen, Ph.D.

 

5.0 ASSIGNMENTS AND SUBCONTRACTS

With a proper 30-day advance notification to Buyer, Dow shall have the right to assign this Agreement in connection with the reorganization, consolidation, spin-off, sale or transfer of assets related to that portion of its business pertaining to the subject matter of this Agreement, either alone or in conjunction with other Dow businesses. In addition, Dow shall have the right to assign its respective rights or obligations and delegate its performance hereunder, in whole or in part, to any of its Affiliates with the prior written consent of Buyer which will not be unduly withheld. Further, Seller agrees to obtain Buyer’s approval before subcontracting this Order or any substantial portion thereof; provided, however, that this limitation shall not apply to the purchase of standard commercial supplies or raw materials.

 

6.0 INSURANCE PROVISION FOR PROCUREMENT CONTRACTS

Without prejudice to Seller’s liability to indemnify Buyer as stated in any Indemnification provision contained in this Agreement, Seller shall procure at its expense and maintain for the duration of this Agreement the insurance policies required below with financially responsible insurance companies, and with policy limits not less than those indicated below.

 

(a) Workers’ Compensation: Coverage for statutory obligations imposed by laws of any State in which the work is to be performed, including where applicable, coverage under the United States Longshoremen’s and Harbor Workers’ Act (USL&H), the Jones Act, and the Defense Base Act (DBA). In addition, the policy shall be endorsed to waive the insurer’s rights of subrogation in favor of Buyer.

 

[*] Certain information in this document 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) Employer’s Liability: Coverage for injuries to employees not covered by workers’ compensation with limits of at least $1,000,000 each accident, $1,000,000 each employee by disease and $1,000,000 policy limit by disease. In addition, the policy shall be endorsed to waive the insurer’s rights of subrogation in favor of Buyer.

 

(c) Commercial General Liability: Coverage for third party bodily injury and property damage, personal injury, products and completed operations, contractual liability, and independent contractors’ liability with limits not less than $1,000,000 per occurrence and $2,000,000 in the aggregate. Buyer, its officers and employees, and Buyer’s customer where required by Buyer’s Agreement with its customer, shall be named as Additional Insured and a waiver of subrogation shall be provided in favor of Buyer.

 

(d) Business Automobile Liability: Coverage for use of all owned, non-owned, and hired vehicles with limits of not less than $1,000,000 per occurrence combined single limit for bodily injury and property damage liability. Buyer, its officers and employees, and Buyer’s customer where required by Buyer’s Agreement with its customer, shall be named as Additional Insured and a waiver of subrogation shall be provided in favor of Buyer.

 

(e) Professional Liability: If seller is performing any professional services, coverage for damages (including financial loss) caused by any acts, errors and omissions arising out Seller’s performance of professional services with limits of not less than $1,000,000 per claim and $2,000,000 in the aggregate.

 

(f) All-Risk Property Insurance: Coverage to repair or replace property, including supplies covered by this Agreement, of Buyer and/or Buyer’s customer which may be in the possession or control of Seller. Buyer shall be named as a Loss Payee with respect to loss or damage to said property and/or supplies furnished by Buyer. Further, Seller assumes the risk of loss or destruction of or damage to any of its property and its employees’ property, whether owned, hired, rented, borrowed, or otherwise. Seller waives and shall ensure that its employees waive all rights of recovery against Buyer and Buyer’s customer and their respective employees for any loss, destruction of or damage to any such property.

The required insurance coverages above shall be primary and non-contributing with respect to any other insurance that may be maintained by Buyer and notwithstanding any provision contained herein, the Seller, and its employees, agents, representatives, consultants, subcontractors and suppliers, are not insured by Buyer, and are not covered under any policy of insurance that Buyer has obtained or has in place.

Any self-insured retentions, deductibles and exclusions in coverage in the policies required under this Article shall be assumed by, for the account of, and at the sole risk of Seller or the subcontractor which provides the insurance and to the extent applicable shall be paid by Seller or such subcontractor. In no event shall the liability of Seller or any subcontractor be limited to the extent of any of insurance or the minimum limits required herein.

Prior to commencement of any work, and within 15 days of any policy renewal that occurs while any work is on-going under this Agreement, Seller shall provide Buyer certificates of insurance evidencing the insurance policies above, including evidence of additional insured status and waivers of subrogation where required. Buyer reserves the right to refuse to accept policies from companies with an A.M. Best Rating of less than A- VII. Seller, or its insurers, shall provide 30 days advance written notice to Buyer in the event of cancellation or material modification of any policy. Failure of Buyer to demand such certificates or to identify any deficiency in the insurance provided shall not be construed as or deemed to be a waiver of Seller’s, or its subcontractors’, obligations to maintain the above insurance coverages.

 

7.0 INDEMNIFICATION

 

(a) Seller shall indemnify, defend and hold SAIC and SAIC’s customer, NIAID, specifically related to Prime Contract # N01-AI-05421 harmless from and against any and all damages, losses, liabilities and expenses arising out of or relating to any claims, causes of action, lawsuits or other proceedings, regardless of legal theory, that result, from Seller’s (or any of Seller’s subcontractors, suppliers, employees, agents or representatives): (i) intentional misconduct, negligence, or fraud, (ii) breach of any representation, warranty or covenant made herein, or (iii) products or services including, without limitation, any claims that such products or services infringe any United States patent, copyright, trademark, trade secret or any other proprietary right of any third party except to the extent such claim arises solely from the use of the Buyer Technology or Buyer Materials. Buyer will give prompt notice of any such claim and, with respect to claims described in clause above, Seller will control the defense, settlement or compromise of such claim, provided, however, that Seller shall berequired to obtain the prior written consent of Buyer before entering into any settlement or compromise that would not relieve Buyer from any liability for past infringement or otherwise would limit the ability of Buyer to realize the full benefit of the Services.

 

(b) Buyer shall indemnify Seller (including its officers, directors and employees) for all third party claims arising from the use by Buyer (or on behalf of Buyer) of samples of products, documentation, or technology received from Seller under this Order, except for any claim for which Seller is required to indemnify Buyer above or any claim arising as a result of the negligence or willful misconduct of Seller. Seller will give prompt notice of any such claim and Buyer will control the defense, settlement or compromise of such claim.

 

[*] Certain information in this document 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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8.0 INFRINGEMENT INDEMNITY

 

(a) Seller warrants that it is not aware of any patent, intellectual property, or industrial property rights of any third party that would be infringed by virtue of Seller performing Services, except to the extent arising solely from the use of Buyer Technology or Buyer Materials. Also, Seller shall indemnify Buyer (including its officers, directors, employees, and SAIC’s customer, NIAID, specifically related to Prime Contract # N01-AI-05421 for all third party claims arising in connection with a patent infringement resulting from or related to the performance of the Services, except to the extent such claim arises solely from the use of the Buyer Technology or Buyer Materials. Buyer will give prompt notice of any such claim and, with respect to claims described above, Seller shall control the defense, settlement or compromise of such claim, provided, however, that Seller shall be required to obtain the prior written consent of Buyer before entering into any settlement or compromise that would not relieve Buyer from any liability for past infringement or otherwise would limit the ability of Buyer to realize the full benefit of the Services.

 

(b) Buyer shall indemnify Seller against liability incurred by Seller in connection with a patent infringement claim by a third party arising as a result of the use by Seller of Buyer Technology or Buyer materials in connection with the performance of the Services. Seller will give prompt notice of any such claim and Buyer will control the defense, settlement or compromise of such claim. As used herein, “Buyer Technology” means all proprietary and/or confidential technical and other information not known to Seller relating to PRODUCT (“PRODUCT” shall mean a full length CSP) and materials in connection with this Order, for which Buyer has intellectual property ownership or patent rights or which Buyer is otherwise authorized to use.

 

(c) Notwithstanding the foregoing paragraph, when this order is performed under the Authorization and Consent of the U.S. Government to infringe U.S. Patents, Seller’s liability for infringement of such Patents in such performance shall be limited to the extent of the obligation of Buyer to indemnify the U.S. Government.

 

9.0 CONFIDENTIALITY AND USE OF BUYER FURNISHED ITEMS/INFORMATION

Both parties agree to maintain the other’s Confidential Information in confidence with the same degree of care each holds its own confidential information. Neither party will use the Confidential Information of the other party except for the performance of the Service described in the Purchase Order. Both parties will disclose the Confidential Information only to its officers, consultants and employees directly concerned with the Service, but will neither disclose the Confidential Information to any third party nor use the Confidential Information for any other purpose. Upon completion of this Order, and at the disclosing parties request, the other party will return all Confidential Information, except that each party may retain one copy of such papers, records or other documents for the sole purpose of determining its continuing obligations under this Order. The parties’ obligation of nondisclosure and the limitations upon the right to use the other party’s Confidential Information, samples and test results shall not apply to the extent that either can demonstrate that the Confidential Information: (a) was in its possession prior to the time of disclosure; or (b) is or becomes public knowledge through no fault or omission of the recipient of the Confidential Information; or (c) is obtained by the recipient from a third party under no obligation of confidentiality to the disclosing party; or (d) if such party is required to disclose the Confidential Information in connection with a legal or administrative proceeding, such party will give the other party prompt notice of such request The disclosing party may seek an appropriate protective order or other remedy or waive compliance or both with the provisions of this Order. If such party seeks a protective order or other remedy, the other party will cooperate. If such party fails to obtain a protective order or waive compliance with the relevant provisions of this Order, the other party will disclose only that portion of the Confidential Information which its legal counsel determines it is required to disclose, after consultation with the other party’s attorneys.

Seller agrees that it will keep confidential and not disclose, disseminate or publish the features of any equipment, tools, gauges, patterns, designs, drawings, engineering data, computer programs and software or other technical or proprietary information furnished, loaned or bailed by Buyer hereunder (hereinafter collectively referred to as “Items/Information”, and use such Items/Information only in the performance of this Subcontract or, if authorized, other orders from Buyer and not otherwise, without Buyer’s prior written consent. Notwithstanding any other provision herein, Buyer and Seller shall each retain ownership of, and all right, title and interest in and to, their respective pre-existing Intellectual Property.

Both Parties agree that the Expression Strains and Production Strain(s) represent Confidential Information from both Parties. Neither Party shall have the right to utilize, license or commercialize the Expression Strains and/or the Production Strain(s) beyond the scope of activities in this agreement without the consent of the other Party.

 

[*] Certain information in this document 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 such items furnished, loaned or bailed by Buyer hereunder, or fabricated, manufactured, purchased, or otherwise acquired by Seller for the performance of this Subcontract and specifically charged to Buyer, are the property of Buyer.

Upon completion, expiration or termination of this Subcontract, Seller shall return all such Items in good condition, reasonable wear only excepted, together with all spoiled and surplus Items to Buyer, or make such other disposition thereof as may be directed or approved by Buyer. Seller agrees to replace, at its expense, all such Items not so returned. Seller shall make no charge for any storage, maintenance or retention of such Items. Seller shall bear all risk of loss for all such Items in Seller’s possession.

Seller also agrees to use any designs or data contained or embodied in such Items in accordance with any restrictive legends placed on such Items by the Buyer or any third party. If Buyer furnishes any material for fabrication hereunder, Seller agrees: (i) not to substitute any other material for such fabrication without Buyer’s prior written consent, and (ii) that title to such material shall not be affected by incorporation in or attachment to any other property.

Materials (“Materials” shall mean cell lysates provided by Seller to Buyer under this Order and any constituents, and any tangible materials that incorporate the foregoing) sent to Buyer under this Order (hereinafter defined as Buyer Materials) shall not be used in human clinical studies. Samples of Materials sent to Seller by Buyer under this Order (hereinafter defined as Seller Materials) shall be used by Seller solely for the purpose of providing the Services for Buyer as set forth herein, and for no other purpose, and shall not be transferred to any other person by Seller.

 

10.0 DISPUTES

Any dispute not disposed of in accordance with the “Disputes Clause” of Schedule B, if any, shall be determined in the following manner.

 

(a) Buyer and Seller agree to enter into Negotiation to resolve any dispute. Both parties agree to negotiate in good faith to reach a mutually agreeable settlement within a reasonable amount of time.

 

(b) If negotiations are unsuccessful, Buyer and Seller agree to enter into binding Arbitration except for intellectual property issues. The American Arbitration Association (AAA) Commercial Arbitration Rules (most recent edition) are to govern this Arbitration. The Arbitration shall take place in the County of San Diego, State of California. The Arbitrator shall be bound to follow the applicable subcontract provisions and California law in adjudicating the dispute. It is agreed by both parties that the Arbitrator’s decision is final, and that no party may take any action, judicial or administrative, to overturn this decision. The judgment rendered by the Arbitrator may be entered in any court having jurisdiction thereof.

Pending any decision, appeal or judgment referred to in this provision or the settlement of any dispute arising under this Subcontract, Seller shall proceed diligently with the performance of this Subcontract.

 

11.0 DEFAULT

 

(a) The Buyer may, by written notice of default to the Seller, terminate the whole or any part of this Subcontract in any one of the following circumstances: (i) if Seller fails to make delivery of the supplies or to perform the services within the time specified herein or any extension thereof; or (ii) if Seller fails to perform any of the other provisions of this Subcontract in accordance with its terms, and in either of these two circumstances does not cure such failure within a period of 10 days (or such longer period as Buyer may authorize in writing) after receipt of notice from the Buyer specifying such failure; or (iii) Seller becomes insolvent or the subject of proceedings under any law relating to bankruptcy or the relief of debtors or admits in writing its inability to pay its debts as they become due.

 

(b) If this Subcontract is so terminated, Buyer may procure or otherwise obtain, upon such terms and in such manner as Buyer may deem appropriate, supplies or services similar to those terminated, Seller, subject to the exceptions set forth below, shall be liable to Buyer for any excess costs of such similar supplies or services.

 

(c) Seller shall continue performance of this Subcontract to the extent not terminated. Buyer shall have no obligations to Seller with respect to the terminated part of this Subcontract except as herein provided. In case of Seller’s default, Buyer’s rights as set forth herein shall be in addition to Buyer’s other rights although not set forth in this Subcontract.

 

(d) Seller shall not be liable for damages resulting from default due to causes beyond the Seller’s control and without Seller’s fault or negligence, provided, however, that if Seller’s default is caused by the default of a subcontractor or supplier, such default must arise out of causes beyond the control of both Seller and subcontractor or supplier, and without the fault or negligence of either of them and, provided further, the supplies or services to be furnished by the subcontractor or supplier were not obtainable from other sources.

 

[*] Certain information in this document 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) Seller agrees to immediately notify Buyer in writing of any actual or potential delay in Sellers performance under this Order. Such notice shall, at a minimum, describe the cause, effect, duration and corrective action proposed by Seller to address the problem. Seller shall give prompt written notice to the Buyer of all changes to such conditions

 

(f) Notwithstanding the foregoing, Seller shall not be liable for any default or delay in performance of any obligation under this Order caused by any of the following: Act of God, war, riot, fire, explosion, accident, flood, sabotage and any other event beyond the reasonable control of Seller; or labor trouble, strike, lockout or injunction (provided that Seller shall not be required to settle a labor dispute against its own best judgment).

 

12.0 GENERAL RELATIONSHIP

The Subcontractor is not an employee of SAIC for any purpose whatsoever. Seller agrees that in all matters relating to this Subcontract it shall be acting as an independent contractor and shall assume and pay all liabilities and perform all obligations imposed with respect to the performance of this Subcontract. Seller shall have no right, power or authority to create any obligation, expressed or implied, on behalf of Buyer and/or the Government and shall have no authority to represent Buyer as an agent.

 

13.0 NON-WAIVER OF RIGHTS

The failure of Buyer to insist upon strict performance of any of the terms and conditions in the Subcontract, or to exercise any rights or remedies, shall not be construed as a waiver of its rights to assert any of the same or to rely on any such terms or conditions at any time thereafter. The invalidity in whole or in part of any term or condition of this subcontract shall not affect the validity of other parts hereof.

 

14.0 APPLICABLE STATE LAW AND COMPLIANCE

This Subcontract shall be governed by and construed in accordance with the laws of the State of Delaware. Seller agrees to comply with the applicable provisions of any federal, state or local law or ordinance and all orders, rules and regulations issued there under.

 

15.0 EXPORT CONTROL COMPLIANCE FOR FOREIGN PERSONS

The subject technology of this Subcontract (together including data, services, and hardware provided hereunder) may be controlled for export purposes under the International Traffic in Arms Regulations (ITAR) controlled by the U.S. Department of State or the Export Administration Regulations (“EAR”) controlled by the U.S. Department of Commerce. ITAR controlled technology may not be exported without prior written authorization and certain EAR technology requires a prior license depending upon its categorization, destination, end-user and end-use. Exports or re-exports of any U.S. technology to [any destination under U.S. sanction or embargo are forbidden.

Access to certain technology (“Controlled Technology”) by Foreign Persons (working legally in the U.S.), as defined below, may require an export license if the Controlled Technology would require a license prior to delivery to the Foreign Person’s country of origin. SELLER is bound by U.S. export statutes and regulations and shall comply with all U.S. export laws. SELLER shall have full responsibility for obtaining any export licenses or authorization required to fulfill its obligations under this Subcontract.

SELLER hereby certifies that all SELLER employees who have access to the Controlled Technology are U.S. citizens, have permanent U.S. residency or have been granted political asylum or refugee status in accordance with 8 U.S.C. 1324b(a)(3). Any non-citizens who do not meet one of these criteria are “Foreign Persons” within the meaning of this clause, but have been authorized under export licenses to perform their work hereunder.

 

16.0 STANDARDS OF BUSINESS ETHICS & CONDUCT

SAIC believes in fair and open competition and is committed to conducting its business fairly, impartially and in an ethical and proper manner. SAIC is owned and controlled by its employee owners. These characteristics make it imperative that SAIC employees adhere to a particularly high ethical standard. Employee ownership both demands and fosters highly ethical conduct because SAIC can be successful only when employees look after long-term interests of the company and resist pressures to compromise SAIC standards. Buyer’s expectation is that Seller also will conduct its business fairly, impartially and in an ethical and proper manner. If Seller has cause to believe that Buyer or any employee or agent of Buyer has acted improperly or unethically under this agreement/order, Seller shall report such behavior to the SAIC Ethics Hotline (800) 435-4234. Copies of The Science Applications International Corporation (SAIC) code of Ethics and contacts for such reports are available on www.saic.com under Corporate Governance.

 

[*] Certain information in this document 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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17.0 ORDER OF PRECEDENCE

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

1. Attachment I: Statement of Work and Schedule dated July 2009.

 

2. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

3. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

4. Attachment C (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls

 

[*] Certain information in this document 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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18.0 ENTIRE AGREEMENT

The parties hereby agree that this Subcontract, including all documents incorporated herein by reference, shall constitute the entire agreement and understanding between the parties hereto and shall supersede and replace any and all prior or contemporaneous representations, agreements or understandings of any kind, whether written or oral, relating to the subject matter hereof.

In witness whereof, the duly authorized representatives of Buyer and the Seller have executed this Subcontract on the Dates shown.

 

THE DOW CHEMICAL COMPANY     SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

/s/ Bart Waters

   

/s/ Gina B. McGeehan

(Signature)     (Signature)
Name:  

Bart Waters

    Name:  

Gina B. McGeehan

(Type or Print)     (Type or Print)
Title:  

R&D Director

    Title:  

Senior Subcontracts Administrator

Date:  

9 Sep 2009

    Date:  

9-14-09

 

[*] Certain information in this document 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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STATEMENT OF WORK

Evaluation of Malaria CSP Expression in Pfenex Expression Technology™

And Process Manufacturing

Malaria Vaccine Production and Support Services

July 2009

 

1. Background

Science Applications International Corporation (SAIC) serves as the prime contractor for the Malaria Vaccine Production and Support Services (MVPSS) contract awarded by the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID). SAIC develops and supports malaria vaccine candidate manufacturing for clinical use as part of DMID’s malaria program.

Currently, the most advanced and efficacious malaria vaccine employed thus far is the RTS,S/AS02 vaccine developed by GlaxoSmithKline, which contains a consensus amino acid sequence for the C-terminal half of the malaria parasite P. falciparum (Pf) circumsporozoite protein (CS) molecule. Administered alone, this vaccine has shown -~ 50% efficacy in infants in Phase II trials in Africa. Further, primate study data indicated that heterologous prime boosting with an adenovirus-based CS vaccine candidate may increase the antigen’s efficacy by enhancing and maintaining the T-cell response (CD8+ and CD4+). Additionally, other studies have been performed which indicate the N-terminal portion of CS may further improve a CS-based vaccine.

The manufacture of a full length CS has been refractory to recombinant expression efforts thus far. This is in large part due to the malaria parasite’s extremely A/T-rich genome with many lysine and arginine repeats, and frequent disulfide bonds. Further, these parasites lack the N-linked glycosylation machinery. Consequently, the expression, purification, and scale-up of many potential recombinant subunit vaccine candidates have beenunsuccessful.Attention must be paid to potential aberrant post-translational modifications and correct folding when expressing and purifying these as recombinant proteins. Thus, SAIC seeks to overcome these manufacturing hurdles of full length CS through the Malaria Vaccine Production and Support Services contract to explore an alternative expression platform and screening services.

 

2. Scope of Work

Independently and not as an agent of SAIC, Dow shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the proof-of-principle evaluation of functional, full-length CSP expression utilizing Pf ēnex Expression Technology™. Optional requirements are also included for Fermentation Optimization and a Technology Transfer package for Fermentation Processes. As part of this support, Dow shall be required to provide summary reports related to the development and manufacturing process, other documentation as required in the deliverables, bacterial cell lysates and reagent-grade CSprotein.

SAIC will provide the following information and materials:

 

  2.1. Background literature/references relating to CSP.

 

[*] Certain information in this document 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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  2.2. An aliquot of reagent grade CSP antigen (for use as an analytical reference standard)

 

  2.3. CSP-specific antibody suitable for Western blot analysis

 

  2.4. Shipping instructions for filtered lysate

 

3. Period of Performance

The period of performance (POP) for this effort is upon award through April 2011.

 

4. Technical Requirements

 

  4.1. Milestone 1: Evaluation of CSP expression in Pf ēnex Expression Technology™

 

  4.1.1. [*]

 

  4.1.1.1. [*]

 

  4.1.1.2. Dow shall transform the resulting plasmids into a strain of Dow’s Pfenex Expression Technology™ and plate onto selective medium.

 

  4.1.1.3. Dow shall select a series of positive clones from assorted vectors and verify correct coding sequences of insert.

 

  4.1.2. Dow shall assess the expression of CSP in Pf ēnex Expression Technology™ at [*] mL scale in a minimum of [*] unique strains

 

  4.1.2.1. Dow shall transform the resulting plasmids into up to [*] host strains. (A minimum of 280 unique Expression Strains)

 

  4.1.2.2. Dow shall perform [*] as a primary screen.

 

  4.1.2.3. Dow shall perform a [*] on selected samples.

 

  4.1.3. Dow shall issue a final report of milestone 1 efforts.

 

  4.1.3.1. Report shall include an executive summary, brief description of test method with a reference to corresponding SOP, test results (i.e. small scale growth, expression, analytical), and conclusion. Copies of raw data including sequencing data shall be included as an appendix.

 

  4.2. Milestone 2 [OPTIONAL]: Fermentation Assessment of CSP in Pf ēnex Expression Technology™

 

  4.2.1. Dow shall screen multiple fermentation conditions at the [*] scale using [*] Expression Strains to evaluate protein quality and expression levels

 

  4.2.1.1. Execute experiments to screen multiple fermentation conditions in mini-bioreactors for protein expression and protein quality. [*] fermentations per strain)

 

  4.2.1.2. Dow shall perform [*] analysis on samples from each of the fermentations.

 

  4.2.1.3. Dow shall perform [*] analysis

 

[*] Certain information in this document 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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  4.2.2. Dow shall confirm selected conditions used at the [*] and verify conditions are suitable at the high cell density fermentation [*] scale to evaluate protein quality and expression levels of selected strains chosen based on data generated in 4.2.1.3.

 

  4.2.2.1. Dow shall confirm selected conditions and strains identified in the screening experiments in a scalable high cell density fermentation process in multiplex fermentors for protein expression and protein quality.

 

  4.2.2.2. Dow shall collect multiple time point samples for evaluation of protein expression levels and quality

 

  4.2.2.3. Dow shall utilize a [*] as appropriate to prepare samples from the best fermentation of each expression strain for supply to SAIC.

4.2.2.3.1. Dow shall transfer to SAIC samples of the filtered whole cell lysate or periplasmic release extract and cell free broth for further in vitro analysis.

4.2.2.3.2. Dow shall perform [*] on samples from each fermentation.

4.2.2.3.3. Dow shall perform [*] and CSP specific assay on selected samples.

4.2.2.3.4. Dow shall perform [*] analysis on selected samples.

 

  4.2.3. Dow shall issue a final report of milestone 2 efforts.

 

  4.2.3.1. Report shall include an executive summary, brief description of test methods with associated reference to SOPs, data (i.e. small scale growth, expression, analytical), and conclusion. Copies of raw data shall be included as an appendix.

 

  4.3. Milestone 3 [OPTIONAL]: Preparation and Characterization of a Pseudomonas-CSP Research Cell Bank (RCB)

Dow shall prepare a non-GMP Research Cell Bank (RCB).

 

  4.3.1. DOW shall generate [*] vials of RCB

 

  4.3.2. DOW will store the RCB a temperature-controlled [*] freezer which has a monitoring system.

 

  4.3.3. A [*] scale fermentation run shall performed to confirm productivity

 

  4.3.3.1. Dow shall harvest and prepare filtered lysate from the [*] fermentation ([*] working volume)

 

[*] Certain information in this document 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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  4.3.3.2. Plasmid retention shall be evaluated using viable count plating of the samples on selective and non-selective media.

 

  4.3.3.3. Structural stability be evaluated using plasmid restriction digests.

 

  4.3.4. Dow shall perform a characterization analysis of the generated Pseudomonas-CSP RCB

 

  4.3.4.1. Phenotype of the strain shall be determined by [*]

 

  4.3.4.2. Culture purity analysis shall be performed on the RCB.

 

  4.3.4.3. [*] shall be confirmed by [*]

 

  4.3.4.4. Dow shall confirm the [*]

 

  4.3.5. Dow shall issue a final report of milestone 3 efforts.

 

  4.3.5.1. Report shall include, but no be limited to, an executive summary, description of cell banking methods and materials used, with associated reference to SOPs, characterization data, raw material certificates of analysis, and copies of raw data.

 

  4.3.5.2. A draft report shall be submitted to SAW two weeks following completion of task and a final copy submitted one week following SAIC comments.

 

5. Quality Requirements

Dow shall maintain a Quality System that meets scientific expectations of traceability, reliability and control. Dow is responsible for the development and demonstration of suitability of contracted deliverables as well as providing reports and managing this project in a manner that meets scientific expectations of traceability, reliability and control ensuring that the filtered whole cell lysate or periplasmic release extract and cell free broth produced and analyzed in the developed process and assays have the quality, and identity they purport.

 

6. Meeting and Conference Requirements

Unless an alternative directive is provided; meeting, conference, and audit support shall include the following:

 

  6.1. Dow shall schedule a kickoff meeting via on-site meeting at Dow’s facilities with SAIC within 7 days of award. The agenda shall be provided by Dow in advance. The purpose of the kickoff meeting is formal introduction of key staff and project management, technical and contractual discussions, and initial action items required to initiate contract work.

 

  6.2. Dow shall participate in biweekly meetings and/or teleconferences with SAIC. Such meetings may include, but are not limited to, meetings to discuss the technical (e.g., assay designs and critical reagents), quality, schedule, regulatory, and contractual aspects of the program and site visits to Dow’s facilities. All visits to Dow’s facility shall be prearranged. Dow shall be responsible for preparing meeting agendas and summaries. Meeting minutes shall be captured by Dow and are due to SAIC within 7 days after the completion of a biweekly teleconference.

 

  6.3. Dow also shall be available for ad hoc support (e.g., phone calls and e-mails) to SAIC as required for project communications.

 

[*] Certain information in this document 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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7. Reporting Requirements

 

  7.1. Monthly Technical and Business Progress Report: A monthly TPR shall be submitted to the SAIC management point of contact by the eighth of each month during subcontract POP.

 

  7.1.1. The TPR shall cover the work accomplished as well as issues and proposed resolutions that occur during each reporting period.

 

  7.1.2. Each TPR also shall contain an updated monthly project management schedule to indicate work completed and any change in schedule. Deliverables shall be incorporated into the schedule.

 

  7.2. Reports should include an updated inventory log to include cell banks, samples, and SAIC provide materials, and a notice of any temperature deviations of equipment storing SAIC material. The report shall also document any changes made to methods and procedures utilized for the CSP expression efforts.

 

  7.2.1. Report shall include invoicing information for work performed during each reporting period and anticipated work activities.

 

  7.3. Documentation to Support an IND or Amendment: Data generated under this subcontract may be incorporated into an MA submission. Dow shall provide a list of relevant SOPs or other control, development and testing documents as requested.

 

8. Subcontract Deliverables

Table 3 summarizes documents and other deliverables due to SAIC at the indicated timelines.

 

[*] Certain information in this document 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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Table 3. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

   Form
           
1    Project Management    Final Project Schedule    To be submitted within 1 week of kickoff meeting; schedule to be baselined within 3 weeks of award    1 electronic file, Preferably .mmp format

2

   Meeting Requirement    Meeting Agenda    1 day prior to regular meetings, 3 days prior to kickoff    1 electronic Word document or email

3

   Meeting Requirement    Meeting Summaries    7 days after meetings    1 electronic Word document

4

   Technical Requirement    Milestone 1 Report    Draft: 2 weeks following completion of procedure Final: 2 weeks after receipt of SAIC comments   

Draft: Word Document

Final: Signed PDF

5    Technical Requirement    Milestone 2 Report [If Funded]    Draft: 2 weeks following completion of testing. Final: 2 weeks after receipt of SAIC comments   

Draft: Word Document

Final: Signed PDF

6

   Technical Requirement    Milestone 2 Fermentation samples [If Funded]    1 week following successful fermentation run.    Sent to SAIC designee in proper shipping containers

7

   Technical Requirement   

Milestone 3

Cell Bank Report [If

Funded]

   Draft: 2 weeks following completion of requirement. Final: 2 weeks after receipt of SAIC comments   

Draft: Word Document

Final: Signed PDF

8

   Technical Requirement    Milestone 3 Lysate from 20 L fermentation [If Funded]    2 weeks following completion of requirement.    Sent to SAIC designee in proper shipping containers
* Days = Calendar days; SAIC shall provide comment within 1 week.

 

[*] Certain information in this document 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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SCHEDULE B - U.S. GOVERNMENT TERMS AND CONDITIONS

Applicable to all U.S. Government “Commercial Items” Subcontracts

PART III - FAR CLAUSES

 

1. DEFINITIONS

In all such clauses, unless the context of the clause requires otherwise, the term “Contractor” shall mean Seller, the term “Contract” shall mean this Order, and the terms “Government,” “Contracting Officer” and equivalent phrases shall mean Buyer and Buyer’s Purchasing Representative, respectively. It is intended that the referenced clauses shall apply to Seller in such manner as is necessary to reflect the position of Seller as a subcontractor to Buyer, to insure Seller’s obligations to Buyer and to the United States Government, and to enable Buyer to meet its obligations under its Prime Contract or Subcontract.

The following definitions apply unless otherwise specifically stated:

“Buyer” - the legal entity issuing this Order.

“Commercial Item” — as defined by FAR 2-101

“FAR” - the Federal Acquisition Regulation.

“Prime Contract” - the Government contract under which this Order is issued.

“Purchasing Representative” - Buyer’s authorized representative.

“Seller” - the legal entity which contracts with the Buyer.

“This Order” - this contractual instrument, including changes.

 

2. IDENTIFICATION OF CONTRACT NUMBERS

Government contract numbers shown on this Order shall be included in subcontracts and purchase orders issued by Seller hereunder.

 

3. COMMERCIAL ITEMS

By FAR 2-101, “Commercial item” means—

(1) Any item, other than real property, that is of a type customarily used by the general public or by non-governmental entities for purposes other than governmental purposes, and—

(i) Has been sold, leased, or licensed to the general public; or

(ii) Has been offered for sale, lease, or license to the general public;

(2) Any item that evolved from an item described in paragraph (1) of this definition through advances in technology or performance and that is not yet available in the commercial marketplace, but will be available in the commercial marketplace in time to satisfy the delivery requirements under a Government solicitation;

(3) Any item that would satisfy a criterion expressed in paragraphs (1) or (2) of this definition, but for— (i) Modifications of a type customarily available in the commercial marketplace; or

(ii) Minor modifications of a type not customarily available in the commercial marketplace made to meet Federal Government requirements. “Minor modifications” means modifications that do not significantly alter the nongovernmental function or essential physical characteristics of an item or component, or change the purpose of a process. Factors to be considered in determining whether a modification is minor include the value and size of the modification and the comparative value and size of the final product. Dollar values and percentages may be used as guideposts, but are not conclusive evidence that a modification is minor;

(4) Any combination of items meeting the requirements of paragraphs (1), (2), (3), or (5) of this definition that are of a type customarily combined and sold in combination to the general public;

(5) Installation services, maintenance services, repair services, training services, and other services if— (i) Such services are procured for support of an item referred to in paragraph (1), (2), (3), or (4) of this definition, regardless of whether such services are provided by the same source or at the same time as the item; and

(ii) The source of such services provides similar services contemporaneously to the general public under terms and conditions similar to those offered to the Federal Government;

 

[*] Certain information in this document 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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(6) Services of a type offered and sold competitively in substantial quantities in the commercial marketplace based on established catalog or market prices for specific tasks performed or specific outcomes to be achieved and under standard commercial terms and conditions. This does not include services that are sold based on hourly rates without an established catalog or market price for a specific service performed or a specific outcome to be achieved. For purposes of these services—

(i) “Catalog price” means a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or vendor, is either published or otherwise available for inspection by customers, and states prices at which sales are currently, or were last, made to a significant number of buyers constituting the general public; and

(ii) “Market prices” means current prices that are established in the course of ordinary trade between buyers and sellers free to bargain and that can be substantiated through competition or from sources independent of the offerors.

 

4. DISPUTES

(a) Notwithstanding any provisions herein to the contrary:

 

  (1) If a decision relating to the Prime Contract is made by the Contracting Officer and such decision is also related to this Order, said decision, if binding upon Buyer under the Prime Contract shall in turn be binding upon Buyer and Seller with respect to such matter; provided, however, that if Seller disagrees with any such decision made by the Contracting Officer and Buyer elects not to appeal such decision, Seller shall have the right reserved to Buyer under the Prime Contract with the Government to prosecute a timely appeal in the name of Buyer, as permitted by the contract or by law, Seller to bear its own legal and other costs. If Buyer elects not to appeal any such decision, Buyer agrees to notify Seller in a timely fashion after receipt of such decision and to assist Seller in its prosecution of any such appeal in every reasonable manner. If Buyer elects to appeal any such decision of the Contracting Officer, Buyer agrees to furnish Seller promptly with a copy of such appeal. Any decision upon appeal, if binding upon Buyer, shall in turn be binding upon Seller. Pending the making of any decision, either by the Contracting Officer or on appeal, Seller shall proceed diligently with performance of this Order.

 

  (2) If, as a result of any decision or judgment which is binding upon Seller and Buyer, as provided above, Buyer is unable to obtain payment or reimbursement from the Government under the Prime Contract for, or is required to refund or credit to the Government, any amount with respect to any item or matter for which Buyer has reimbursed or paid Seller, Seller shall, on demand, promptly repay such amount to Buyer. Additionally, pending the final conclusion of any appeal hereunder, Seller shall, on demand, promptly repay any such amount to Buyer. Buyer’s maximum liability for any matter connected with or related to this Order which was properly the subject of a claim against the Government under the Prime Contract shall not exceed the amount of Buyer’s recovery from the Government.

 

  (3) If this Order is issued by Buyer under a Government Subcontract rather than a Prime Contract, and if Buyer has the right under such Subcontract to appeal a decision made by the Contracting Officer under the Prime Contract in the name of the Prime Contractor (or if Buyer is subject to any arbitrator’s decision under the terms of its subcontract), and said decision is also related to this Order, this Disputes Clause shall also apply to Seller in a manner consistent with its intent and similar to its application had this Order been issued by Buyer under a Prime Contract with the Government.

 

[*] Certain information in this document 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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  (4) Seller agrees to provide certification that data supporting any claim made by Seller hereunder is made in good faith and that the supporting data is accurate and complete to the best of Seller’s knowledge or belief, all in accordance with the requirements of the Contract Disputes Act of 1978 (41USC601-613) and implementing regulations. If any claim of Seller is determined to be based upon fraud or misrepresentation, Seller agrees to defend, indemnify and hold Buyer harmless for any and all liability, loss, cost or expense resulting therefrom.

(b) Any dispute not addressed in paragraph (a) above, will be subject to the disputes clause of Schedule A of this subcontract agreement.

 

5. OTHER GOVERNMENT PROCUREMENT

Nothing contained herein shall be construed as precluding the Seller from producing items for direct sale to the Government, utilizing therefore all hardware and/or software, including designs, drawings, engineering data or other technical or proprietary information furnished Seller by Buyer, provided the Government has the unrestricted right to permit the use thereof for such purpose.

 

6. TERMINATION FOR CONVENIENCE

The Buyer may terminate performance of work under this subcontract in whole, or in part if the Purchasing Representative determines that a termination is in the Buyer’s interest. The Buyer shall terminate by delivering to the Seller a Notice of Termination specifying the extent of termination and the effective date. In the event of such termination, the Seller shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this order, the Seller shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Seller can demonstrate to the satisfaction of the Buyer using its standard record keeping system, have resulted from the termination. The Seller shall not be required to comply with the cost accounting standards or cost principles for this purpose. The Seller shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

 

7. ANTI-KICKBACK ACT OF 1986

By accepting this Order, Seller certifies that it has not offered, provided, or solicited and will not offer, provide, or solicit any kickback in violation of the Anti-Kickback Act of 1986 (41 USC §§ 51-58). “Kickback” means any money, fee, commission, credit, gift, gratuity, thing of value, or compensation of any kind that is provided, directly or indirectly, for the purpose of improperly obtaining or rewarding favorable treatment in connection with a prime contract or a subcontract relating to a prime contract. Seller agrees to indemnify, defend, and hold Buyer harmless from and against any losses, liabilities, offsets and expenses (including reasonable attorney’s fees) arising out of or relating to Seller’s failure to comply with the provisions of the Anti-Kickback Act.

 

8. FAR CLAUSES APPLICABLE TO THIS ORDER

The clauses in FAR Subpart 52.2 referenced in subparagraph (a), the clauses applicable in subparagraph (b), and those referenced and checked in subparagraph (c) below, in effect on the date of this Order, are incorporated herein and made a part of this Order. To the extent that an earlier version of any such clause is included in the Prime Contract or Subcontract under which this Order is issued, the date of the clause as it appears in such Prime Contract or Subcontract shall be controlling and said version shall be incorporated herein. The extent of the flow down shall be as required by the clause.

 

[*] Certain information in this document 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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(a) The following clauses are applicable to this order:

 

Clause & FAR

Ref.

   Title of Clause
52.219-8    Utilization of Small Business Concerns [15 U.S.C. 637(d)(2) and (3)] In all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $550,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities .
52.222-26    Equal Opportunity (E.O. 11246)
52.222-35    Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (38 U.S.C. 4212)
52.222-36    Affirmative Action for Workers with Disabilities (29 U.S.C. 793)
52.222-39    Notification of Employees Rights Concerning Payment of Union Dues or Fees (E.O. 13201)
52.222-41    Service Contract Act of 1965, as Amended (41 U.S.C. 351, et. Seq.)
52.247-64    Preference for Privately-Owned U.S. Flag Commercial Vessels (46 U.S.C. Appendix 1241(b) and 10 U.S.C. 2631)
52.227-11    Patent Rights June 1997

(b) The Seller shall comply with the FAR clauses in this paragraph (b) that the Buyer has indicated as being incorporated into this order by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

 

    

Clause &

FAR Ref.

   Title of Clause
¨    52.203-6    Restrictions on Subcontractor Sales to the Government, with Alternate I (41 U.S.C. 253g and 10 U.S.C. 2402) (If order exceeds $100,000)
¨    52.219-9    Small Business Subcontracting Plan [15 U.S.C. 637(d)(4)] (if order to a large business and exceeds $550,000)
¨    52.219-9    Alternate I
¨    52.219-9    Alternate II
¨    52.219-16    Liquidated Damages-Subcontracting Plan (15 U.S.C. 637(d)(4)(F)(i)) (If FAR 52.219-9 is incorporated)
¨    52.222-3    Convict Labor (E.O. 11755)
¨    52.222-19    Child Labor-Cooperation with Authorities and Remedies (E.O. 13126)
¨    52.222-21    Prohibition of Segregated Facilities
¨    52.222-37    Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (38 U.S.C. 4212)
¨    52.225-1    Buy American Act - Supplies (41 U.S.C. 10a-10d)
¨    52.225-3    Buy American Act - Free Trade Agreements - Israeli Trade Act (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, Pub. L. 108-77, 108-78, 108-286 & 109-53)
¨    52.225-3    Alternate I
¨    52.225-3    Alternate II
¨    52.225-5    Trade Agreements (19 U.S.C. 2501, et. seq., 19 U.S.C. 3301 note)
¨    52.225-13    Restrictions on Certain Foreign Purchases (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury)
¨    52.239-1    Privacy or Security Safeguards (5 U.S.C. 552a)

 

[*] Certain information in this document 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) The Seller shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, which the Buyer has indicated as being incorporated in this Order by reference to implement provisions of law or execute orders applicable to acquisitions of commercial items:

 

    

Clause &

FAR Ref.

   Title of Clause
¨    52.222-42    Statement of Equivalent Rates for Federal Hires (29 U.S.C. 206 and 41 U.S.C. 351 et. seq.)
¨    52.222-43    Fair Labor Standards Act and Service Contract Act - Price Adjustment (Multiple Year and Option Contracts) (29 U.S.C. 206 and 41 U.S.C. 351 et. seq.)
¨    52.222-44    Fair Labor Standards Act and Service Contract Act - Price Adjustment (29 U.S.C. 206 and 41 U.S.C. 351 et. seq.)

(d) In addition to the clauses listed in paragraphs (a), (b) and (c) above, if this order will contain Government property, the below listed clauses as checked, are applicable:

 

    

Clause &

FAR Ref.

   Title of Clause
¨    52.245-1    Government Property
¨    52.245-2    Government Property Installation Operation Services
¨    52.245-9    Use & Charges (When FAR 52.245-1 is incorporated)

(e) In addition to the clauses listed in paragraphs (a) (b) (c) and (d) above, if this order will be performed under any order issued by an agency of the Department of Defense, the below listed clauses are applicable:

 

    

Clause &

FAR Ref.

   Title of Clause
¨    252.219-7003    Small Business Subcontracting Plan (DoD Contracts) (15 U.S.C. 637)
¨    252.219-7004    Small Business Subcontracting Plan (Test Program) (15 U.S.C. 637 note)
¨    252.225-7001    Buy American Act and Balance of Payments Program (41 U.S.C. 10a-10d, E.O. 10582)
¨    252.225-7012    Preference for Certain Domestic Commodities (10 U.S.C. 2533a) ( If order exceeds $100,000 )
¨    252.225-7014    Preference for Domestic Specialty Metals, Alternate I (10 U.S.C. 2241 note)
¨    252.225-7015    Restriction on Acquisition of Hand or Measuring Tools (10 U.S.C. 2533a)
¨    252.225-7021    Trade Agreements (19 U.S.C. 2501-2518 and 19 U.S.C. 3301 note)
¨    252.225-7036    Buy American Act—Free Trade Agreements—Balance of Payments Program (41 U.S.C. 10a-10d and 19 U.S.C. 3301 note)
¨    252.226-7001    Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns (Section 8021 of Public Law 107-248 and similar sections in subsequent DoD appropriations acts) (If order exceeds $500,000)
¨    252.227-7015    Technical Data-Commercial Item
¨    252.237-7019    Training for Contractor Personnel Interacting with Detainees (Section 1092 of Public Law 108-375)
¨    252.246-7003    Notification of Potential Safety Issues
¨    252.247-7023    Transportation of Supplies by Sea (10 U.S.C. 2631)
¨    252.247-7024    Notification of Transportation of Supplies by Sea (10 U.S.C. 2631)

 

[*] Certain information in this document 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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SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT)

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290
Pfenex Inc.    MODIFICATION #:    1
ADDRESS:    DPAS RATING:    NA

5501 Oberlin Dr.

 

San Diego, CA 92121

   TYPE:   

FIRM FIXED PRICE COMMERCIAL

 

ITEMS (GOVERNMENT)

   VALUE:    $336,800.00

Modification No. 1 to Subcontract No. P010022290 is issued to assign Subcontract No. P010022290 from The Dow Chemical Company to Pfenex Inc. (Pfenex).

 

1.0 MODIFICATION EFFECTIVE DATE

This Modification No. 1 to Subcontract No. P010022290 is effective December 1, 2009.

 

2.0 ASSIGNMENTS

In accordance with Subcontract No. P010022290 Section 5.0, Assignments and Subcontracts, and the Novation Agreement signed by Science Applications International Corporation (SAIC), The Dow Chemical Company, and Pfenex, attached hereto, Subcontract No. P010022290 is assigned from The Dow Chemical Company to Pfenex.

 

3.0 PRICE

The total not-to-exceed price of Subcontract No. P010022290 remains $336,800.00. Of this amount, at the time of assignment of this Subcontract total payments to The Dow Chemical Company are $62,282.50. The remaining Subcontract price available to be paid to Pfenex is $274,317.50.

 

4.0 TECHNICAL AND CONTRACTUAL REPRESENTATIVES

Pfenex (SELLER) Technical and Contractual representatives are:

 

TECHNICAL:   

Charles H. Squires, Ph.D.

  
CONTRACTUAL:   

Patrick Lucy

  
SAIC (BUYER) Technical and Contractual representatives remain:   
TECHNICAL:   

Steve Huang

  
CONTRACTUAL:   

Gina B. McGeehan

  

**

All other Subcontract terms and conditions,

including Key Personnel and Statement of Work, remain unchanged.

**

 

[*] Certain information in this document 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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Modification No. 1 Attachment : Agreement of Assignment and Assumption, effective December 1, 2009

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract modification No. 1 on the dates shown.

 

PFENEX, INC.     SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

 

   

/s/ Janet E. Lilly

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Janet E. Lilly

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Senior Subcontracts Administrator

Date:  

 

    Date:  

January 20, 2010

 

[*] Certain information in this document 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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AGREEMENT OF ASSIGNMENT AND ASSUMPTION

THIS AGREEMENT is made and entered into effective December 1, 2009 by and among The Dow Chemical Company, a Delaware corporation (“Transferor); Pfenex, Inc., a Delaware corporation (“Transferee”), and Science Applications International Corporation (“SAIC”), a Delaware corporation.

RECITALS

A. SAIC has entered into a certain contract with Transferor, namely: Subcontract Agreement No. P010022290 (the “Contract”). The term “Contract”; as used in this Agreement, means the above contract including all modifications thereto made between SAIC and Transferor prior to the effective date of this Agreement.

B. As of December 1, 2009 Transferor has transferred to Transferee all the assets of Transferor’s biopharmaceuticals business.

C. The parties hereto desire that SAIC consent to the assignment of the Contract to Transferee.

D. NOW, THEREFORE , for and in consideration of the premises and other good and sufficient consideration, the parties hereto agree as follows:

1. Transferor confirms to SAIC the full and complete assignment of the Contract to Transferee (the “Assignment”) and waives any claims and rights against SAIC that it now has or may have in the future in connection with the Contract.

2. Transferee represents to SAIC that by virtue of the Assignment, Transferee has acquired from Transferor all of the assets of the Transferor relating to the Contract, and that Transferee is in a position to fully perform all of the obligations of the Transferor under the Contract.

3. SAIC agrees to be bound by and to perform the Contract in accordance with the conditions contained in the Contract. Transferee assumes all obligations and liabilities of, and all claims against, Transferor under the Contract as if Transferee were the original party to the Contract.

4. Transferee ratifies all previous actions taken by Transferor with respect to the Contract, with the same force and effect as if the action had been taken by Transferee.

5. SAIC recognizes Transferee as Transferor’s successor in interest in and to the Contract. Transferee by this Agreement becomes entitled to all rights, titles, and interests of Transferor in and to the Contract as if Transferee were the original party to the Contract.

6. Except as expressly provided in this Agreement, nothing in this Agreement shall be construed as a waiver of any rights of SAIC against Transferor for Transferor’s performance or failure to perform prior to the effective date of this Assignment. SAIC reserves any and all claims that it may have against Transferor to Transferor’s performance or failure to perform the Contract up to the date of this Assignment, including, but not limited to, any further claim of the Government, no such claim(s) being known or anticipated at this time.

7. All payments and reimbursements previously made by Transferor to SAIC, and all other previous actions taken by SAIC under the Contract, shall be considered to have discharged those parts of SAIC’s obligations under the Contract.

8. Payment of any and all proper invoices under the Contract submitted by SAIC to Transferor prior to the date this Agreement is fully executed shall be paid to SAIC by Transferee. Thereafter, all payments under the Contract after the date this Agreement is fully executed by all the parties hereto shall be made by Transferee.

 

[*] Certain information in this document 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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9. The Transferor will complete all Contract closeout actions specified in Subcontract Agreement No. P010022290 as necessary and requested by SAIC

10. SAIC shall be responsible for no costs as a result of this Agreement.

11. This Agreement shall be governed by and interpreted in accordance with the laws of the State of California.

12. Transferor waives notice of, and consents to, any further modifications of the Contract.

13. The Contract shall remain in full force and effect, except as modified by this Agreement. Each party has executed this Agreement as of the day and year first above written.

IN WITNESS WHEREOF, the parties have executed this assignment effective as of the date first written above on the dates indicated below.

 

TRANSFEROR:     TRANSFEREE:
The Dow Chemical Company     Pfenex Inc.
2030 Dow Center     5501 Oberlin Drive
Midland, MI 48674     San Diego, CA 92121
By:  

/s/ Authorized Person

    By:  

/s/ Authorized Person

Title:  

Business R&D Director

    Title:  

V.P. Business Development

Date:  

December 22, 2009

    Date:  

January 7, 2010

SCIENCE APPLICATIONS INTERNATIONAL CORPORTATION      
5202 Presidents Court, Suite 110      
Frederick, MS 21703      
By:  

/s/ Janet E. Lilly

     
Title:  

Sr. Subcontracts Admin

     
Date:  

January 20, 2010

     

 

[*] Certain information in this document 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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SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT)

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290
Pfenex Inc.    MODIFICATION #:    2
ADDRESS:    DPAS RATING:    NA
301 Newbury Street PMB 251, Danvers, MA 01923    TYPE:   

FIRM FIXED PRICE

 

COMMERCIAL ITEMS

 

(GOVERNMENT)

   VALUE:    $486,800.00

Modification No. 2 to Subcontract No. P010022290 is issued to Pfenex Inc. (Pfenex) to add funding and Statement of Work for the Production of additional filtered lysates, and purified full-length CSP expressed in P f ēnex Expression Technology™. As part of this support, Pfenex shall be required to provide summary reports related to the development and manufacturing process, other documentation as required in the deliverables, bacterial cell lysates and reagent- grade CS protein of 80-85% purity..

 

  1.0 MODIFICATION EFFECTIVE DATE

This Modification No. 2 to Subcontract No. P010022290 is effective May 24, 2010.

 

  2.0 PRICE

The total not-to-exceed price of Subcontract No. P010022290 is increased by $150,000.00 from $336,800.00.00 to $486,800.00. Of this amount, at the time of assignment of this Subcontract total payments to The Dow Chemical Company were $62,282.50 thus the remaining Subcontract price available to be paid to Pfenex is $424,517.50.

 

  3.0 INVOICES

Invoices shall be prepared in duplicate and contain the following information; subcontract number, subproject number, Stage #. Invoices will be mailed to:

Science Applications International Corporation

Attention: Earleen K. Smith

5202 Presidents Court, Suite 110

Frederick, Maryland 21703

Earleen.k.smith@saic.com

 

  3.0 TECHNICAL AND CONTRACTUAL REPRESENTATIVES

Pfenex (SELLER) Technical and Contractual representatives are:

 

  TECHNICAL:   

Charles H. Squires, Ph.D.

  
  CONTRACTUAL:   

Patrick Lucy

  

 

[*] Certain information in this document 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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SAIC (BUYER) Technical and Contractual representatives remain:

 

  TECHNICAL:   

Steve Huang

  
  CONTRACTUAL:   

Earleen K. Smith

  

4.0 Statement of Work entitled “Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™, and Process Manufacturing, Malaria Vaccine Production and Support Services, May 4, 2010, Subcontract Modification 2” is herein incorporated into and made part of Subcontract No. P010022290.

***

All other Subcontract terms and conditions remain unchanged.

***

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract modification No. 2 on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Earleen K. Smith

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Earleen K. Smith

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

05/24/10

    Date:  

5/24/10

 

[*] Certain information in this document 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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STATEMENT OF WORK

Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™

and Process Manufacturing

Malaria Vaccine Production and Support Services

May 4, 2010

Subcontract Modification 2

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the production of additional filtered lysates, and purified full-length CSP expressed in P f ēnex Expression Technology™. As part of this support, Pfenex shall be required to provide summary reports related to the development and manufacturing process, other documentation as required in the deliverables, bacterial cell lysates and reagent-grade CS protein of [*].

SAIC will provide the following information and materials:

 

  1.1.1. Background literature/references relating to Circumsporozoite Protein (CSP).

 

  1.1.2. Additional anti-CSP mAbs and control CSP, if required.

 

  1.1.3. Shipping instructions for filtered lysates and purified CSP protein

 

2. Technical Requirements

 

  2.1. Milestone 1: Provide filtered lysates to SAIC

 

  2.1.1. Pfenex shall use [*] to prepare filtered lysates starting from [*] cell paste from the best fermentation performed in Stage 2 for each of the three strains [*].

 

  2.1.2. Pfenex shall ship the filtered lysates to a contractor designated by SAIC.

 

  2.2. Milestone 2: [*] protein to SAIC

 

  2.2.1. Pfenex shall evaluate up to four [*] to capture CSP protein using batch binding experiments in 96-well plate format.

 

  2.2.2. Pfenex shall conduct small scale [*] runs using up to two selected [*] to evaluate purification of CSP protein.

 

  2.2.3. Pfenex shall conduct small scale secondary chromatography runs using up to two selected [*] using elution pool from the primary capture column runs.

 

  2.2.4. Pfenex shall evaluate up to two [*] for reduction of [*].

 

  2.2.5. Pfenex shall analyze the final purified proteins and the filtered lysate using analytical methods including [*]

 

  2.2.5.1. Pfenex shall assess the difference in endotoxin level between filtered lysate and purified CSP.

 

  2.2.5.2. Pfenex shall also assess [*]

 

  2.2.6. Pfenex shall ship the resulting purified CSP protein (approximately 10 mg) to SAIC.

Note: The purification activities are designed to result in 10 mg of purified CSP protein. Pfenex will carry out the activities as described above, however if additional activities are required to achieve the 10 mg deliverable an additional scope of work under a new contract modification may be necessary.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

1


  2.3. Pfenex shall issue a final report of milestone 1 and 2 efforts.

 

  2.3.1. Report shall include an executive summary, brief description of methods, results and conclusions, inventory of reagents provided by SAIC, and raw data in PDF format.

 

3. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1

   Technical   

[*]

   Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor

2

   Technical   

[*]

   Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor

3

   Technical    Unused reagents provided by SAIC    Within 2 week2 of SAIC request    Sent to SAIC designee in proper shipping containers

4

   Reporting    Weekly Email Update    COB Friday    Email

5

   Reporting    Final Report    Draft: 2 weeks following completion Final: 2 weeks after receipt of SAIC comments    Draft: Word Document
Final: Signed Pdf

 

* Days = Calendar days; SAIC shall provide comment within 1 week.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

2


LOGO

SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT)

 

SUBCONTRACTOR:   SUBCONTRACT #:    P010022290
Pfenex Inc.   MODIFICATION #:    3
ADDRESS:   DPAS RATING:    Not Rated
301 Newbury Street PMB 251, Danvers, MA 01923   TYPE:   

FIRM FIXED PRICE COMMERCIAL

 

ITEMS (GOVERNMENT)

  VALUE:    $486,800.00

Modification No. 3 to Subcontract No. P010022290 is issued to Pfenex Inc. (Pfenex) to update the payment terms with regard to the funding added as part of Modification #2.

 

Article 1.4 PAYMENT – is amended to read as follows:

(a) Original Subcontract Award: For each Stage of work there will be two invoices each totaling 50 % of the price for each Stage of Work, an initial invoice upon commencement of the Stage and a final invoice upon acceptance of the final report for each Stage.

(b) Subcontract Modification #2: For each of the two Milestones in the Statement of Work dated May 4, 2010 (modification #2) there will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

(c) Payment terms will be Net 45 days from date of invoice. Upon receipt of invoice Buyer shall within five (5) business days review the invoice and determine if the invoice is acceptable. “If Buyer reasonable deems the invoice unacceptable Buyer shall contact Seller and Seller shall reissue a conforming invoice with a new date of invoice. If (1) Buyer does not pay on time or (2) Buyer’s financial responsibility becomes unsatisfactory (S&P rating below BBB- or Moody’s rating below Baa3) to Seller and Seller deems itself insecure, Seller may accelerate the due date and demand immediate payment on any outstanding invoice for Product, or may require cash payments or satisfactory security for future deliveries and for payment of all sums owed under this Agreement. Buyer agrees to pay all costs and expenses, including reasonable attorney’s fees, incurred by Seller in the collection of any sum payable by Buyer to Seller, or in the exercise of any remedy. Seller may charge Prime +2% on all overdue amounts.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract modification No. 3 on the dates shown.

 

PFENEX INC.   SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Earleen K. Smith

(Signature)   (Signature)
Name:  

Patrick Lucy

    Name:  

Earleen K. Smith

(Type or Print)   (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

June 14, 2010

    Date:  

6/15/10

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

 

SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT)

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290
Pfenex Inc.    MODIFICATION #:    4
ADDRESS:    DPAS RATING:    Not Rated
301 Newbury Street PMB 251, Danvers, MA 01923    TYPE:   

FIRM FIXED PRICE COMMERCIAL

 

ITEMS (GOVERNMENT)

   VALUE:    $721,800.00

Modification No. 4 to Subcontract No, P010022290 Is issued to Pfenex Inc, (Pfenex) to add funding and Statement of Work for the Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™ and Process Manufacturing.

 

Article 1.0 PRICE is amended to read as follows:

The total not-to-exceed price of Subcontract No. P010022290 is increased by $235,000.00 from $486,800.00 to $721,800.00 including profit.

 

Article 1.4 PAYMENT – is amended to read as follows:

(a) Original Subcontract Award: For each Stage of work there will be two invoices each totaling 50 % of the price for each Stage of Work, an initial invoice upon commencement of the Stage and a final invoice upon acceptance of the final report for each Stage.

 

(b) Subcontract Modification #2: For each of the two Milestones in the Statement of Work dated May 4, 2010 (modification #2) there will be two invoices each totaling 50% of the price for each Milestone, an Initial Invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

Subcontract Modification #4: For each of the two Milestones in the Statement of Work dated November 15, 2010 (modification #4) there will be two Invoices each totaling 50% of the price for each Milestone, an Initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

(c) Payment terms will be Net 45 days from date of invoice. Upon receipt of invoice Buyer shall within five (5) business days review the Invoice and determine if the invoice is acceptable. If Buyer reasonable deems the Invoice unacceptable Buyer shall contact Seller and Seller shall reissue a conforming Invoice with a new date of invoice. If (1) Buyer does not pay on time or (2) Buyer’s financial responsibility becomes unsatisfactory (S&P rating below BBB- or Moody’s rating below Baa3) to Seller and Seller deems itself insecure, Seller may accelerate the due date and demand immediate payment on any outstanding invoice for Product, or may require cash payments or satisfactory security for future deliveries and for payment of all sums owed under this Agreement. Buyer agrees to pay all costs and expenses, including reasonable attorney’s fees, incurred by Seller in the collection of any sum payable by Buyer to Seller, or in the exercise of any remedy. Dow may charge Prime +2% on all overdue amounts.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 2


LOGO

 

 

Article 17.0 ORDER OF PRECEDENCE – is amended to road as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

1. Attachment I: Statement of Work and Schedule dated July 2009, and Subcontract Modification #2 dated May 4, 2010 and Subcontract Modification #4 dated November 15, 2010.

 

2. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

3. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

4. Attachment C (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract modification No. 2 on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Earleen K. Smith

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Earleen K. Smith

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

12/15/10

    Date:  

12/15/10

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 2


LOGO

STATEMENT OF WORK

Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™

and Process Manufacturing

Malaria Vaccine Production and Support Services

November 15, 2010

Subcontract Modification 4

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, and facilities for the purification of SAIC EP533-036/C5533-129 CS protein expressed in P f ēnex Expression Technology™. As part of this project, Pfenex is required to provide related meeting support, reports, and deliverables as listed in Table 1.

 

  1.1. SAIC will provide the following information and materials:

 

  1.1.1. Background literature/references relating to Circumsporozoite Protein (CSP).

 

  1.1.2. Additional anti-CSP mAbs and control CSP, if required,

 

  1.1.3. Shipping instructions for purified CSP protein

 

2. Technical Requirements

As a follow-on to the successful production, testing, and selection of a CS protein expressing cell line under the original subcontract and Mod 2 which composed of : (i)-Evaluation of CSP expression (Stage 1), (ii)-Fermentation assessment of CSP (Stage 2), (iii)-CSP purification (Stage 2A/Mod 2) and (iv)-Preparation and characterization of Pseudumonas-CSP Research Cell Bank (RCB) (Stage 3), SAIC requires Pfenex to provide [*] using the process established in Stage 2A.

 

  2.1. Stage 3A: Protein purification

 

  2.1.1. Pfenex shall provide [*] of purified CSP from clone [*]

 

  2.1.1.1. Pfenex shall use the [*] working fermentation already available from Stage 3 plus additional fermentation if needed. Pfenex shall use the process established in Stage 2A for the protein purification efforts.

 

  2.1.2. The purified CSP should have purity greater than [*]% and endotoxin level suitable for [*]

 

  2.1.3. The final product shall be at [*]

 

  2.1.4. Pfenex shall calculate % of CSP in starting, intermediate, and final materials in the process and include the data in the final report.

 

  2.1.5. Pfenex shall conduct analytical testing of the purified CSP including but not limited to [*]

 

  2.1.5.1. [*]

 

  2.1.6. [*]

 

  2.1.7. Pfenex shall ship the purified CSP to a SAIC designated facility.

 

  2.1.8. Pfenex shall issue a final report of the purification efforts. Report shall include an executive summary, brief description of methods, results and conclusions, inventory of reagents provided by SAIC, and raw data in PDF format.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

1


LOGO

 

 

3. Table 1 Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Technical    [*]    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
2    Technical    Unused reagents provided by SAIC    Within 2 week2 of SAIC request    Sent to SAIC designee in proper shipping containers
3    Reporting    Weekly Email Update    COB Friday    Email
4    Reporting    Final Report   

Draft: 2 weeks following completion

Final: 2 weeks after receipt of SAIC comments

  

Draft: Word Document

Final: Signed Pdf

 

* Days = Calendar days; SAIC shall provide comment within 1 week.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

2


LOGO

SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT)

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290
Pfenex Inc.    MODIFICATION #:    5
ADDRESS:    DPAS RATING:    Not Rated
5501 Oberlin Drive San Diego, CA 92121    TYPE:   

FIRM FIXED PRICE COMMERCIAL

 

ITEMS (GOVERNMENT)

   VALUE:    $3,093,173.00

Modification No. 5 to Subcontract No. P010022290 is issued to Pfenex Inc. (Pfenex) to add subcontract value, incremental funding and a Statement of Work dated December 23, 2010 for the Evaluation of Malaria CSP Expression in Pfenex Expression Technology™ and Process Manufacturing.

Article 1.0 PRICE is amended to read as follows:

The total not-to-exceed price of Subcontract No. P010022290 is increased by $2,371,373.00 from $721,800.00 to $3,093,173.00 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2011. The total FUNDING of Subcontract No. P010022290 is increased by $1,591,328.02 from $721,800.00 to $2,313,128.02 including profit

Article 1.4 PAYMENT – is amended to read as follows:

(a) Original Subcontract Award: For each Stage of work there will be two invoices each totaling 50 % of the price for each Stage of Work, an initial invoice upon commencement of the Stage and a final invoice upon acceptance of the final report for each Stage.

Subcontract Modification #2: For each of the two Milestones in the Statement of Work dated May 4, 2010 (modification #2) there will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

Subcontract Modification #4: For each of the two Milestones in the Statement of Work dated November 15, 2010 (modification #4) there will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

Subcontract Modification #5: The following table shall be utilized for Milestone Invoice dates of submission and Invoice Amounts for the Milestones defined in the Statement of Work dated December 13, 2010 (modification #5). There will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 3


LOGO

 

 

Milestone

  

Stage

   Dollar
Amount
        

Expected Invoice

date

   Expected invoice
amount
 

Milestone 2.1

   Stage 4      [*   Start    1/17/11    $ [*
        Finish    4/19/11    $ [*

Milestone 2.2

   Stage 5      [*   Start    3/22/11    $ [*
        Finish    9/16/11    $ [*

Milestone 2.3

   Stage 6      [*   Start    1/17/11    $ [*
        Finish    5/24/11    $ [*

Milestone 2.4

   Stage 7      [*   Start    8/19/11    $ [*
        Finish    2/3/12    $ [*

Milestone 2.5

   Stage 8      [*   Start    1/10/12    $ [*
        Finish    6/3/12    $ [*

Milestone 2.6

   Stage 9      [*   Start    11/18/11    $ [*
        Finish    2/7/12    $ [*

Milestone 2.7

   Report      [*   Start    5/3/12    $ [*
        Finish    5/24/12    $ [*

(b) Payment terms will be Net 45 days from date of invoice. Upon receipt of invoice Buyer shall within five (5) business days review the invoice and determine if the invoice is acceptable. If Buyer reasonable deems the invoice unacceptable Buyer shall contact Seller and Seller shall reissue a conforming invoice with a new date of invoice. If (1) Buyer does not pay on time or (2) Buyer’s financial responsibility becomes unsatisfactory (S&P rating below BBB- or Moody’s rating below Baa3) to Seller and Seller deems itself insecure, Seller may accelerate the due date and demand immediate payment on any outstanding invoice for Product, or may require cash payments or satisfactory security for future deliveries and for payment of all sums owed under this Agreement. Buyer agrees to pay all costs and expenses, including reasonable attorney’s fees, incurred by Seller in the collection of any sum payable by Buyer to Seller, or in the exercise of any remedy. Pfenex may charge Prime +2% on all overdue amounts.

Article 17.0 ORDER OF PRECEDENCE — is amended to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment Statement of Work and Schedule dated December 23, 2010

 

  2. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  3. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  4. Attachment C (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls

5. Attachment II: Statement of Work and Schedule dated July 2009, Subcontract Modification #2 dated May 4, 2010, and Subcontract Modification #4 dated November 15, 2010.

Article 19.0 SURVIVAL — Is added to the Subcontract to read as follows:

19.0 SURVIVAL

If this Subcontract expires, is completed, or is terminated, Seller shall not be relieved of those obligations contained in the following articles: 1.0, 1.5, 3.0, 7.0, 8.0, 9.0, 10.0, 12.0, 14.0, 15.0, and 17.0.

All other Subcontract terms and conditions remain unchanged.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 3


LOGO

 

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract modification No. 5 on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Earleen K. Smith

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Earleen K. Smith

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

1/10/11

    Date:  

1/10/11

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 3 of 3


Statement of Work

Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™

and Process Manufacturing

Malaria Vaccine Production and Support Services

December 23, 2010

Subcontract Modification 5

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, and facilities for the full development of a manufacturing process for the SAIC Circumsporozoite Protein (CSP) expressed from C5533-129 clone using P f ēnex Expression Technology™ and technical transfer of the process to a SAIC designated facility. The process shall be suitable for a scale up, at a minimum, of a [*] fermentation scale and follow-on purification, upon transfer. As part of this project, Pfenex is required to provide related meeting support, reports, and deliverables as listed in Table 1 .

1.1. SAIC will provide the following information and materials:

 

    Background literature/references relating to CSP.

 

    Additional anti-CSP monoclonal antibodies (mAbs) and control CSP, if required.

 

    Shipping instructions for purified CSP protein and other materials.

 

2. Technical Requirements

As a follow-on to the successful production, testing, and selection of a CSP expressing cell line under the original subcontract and Mod 2 which was composed of: (i)-Evaluation of CSP expression (Stage 1), (ii)-Fermentation assessment of CSP (Stage 2), (iii)-CSP purification (Stage 2A/Mod 2) and (iv)-Preparation and characterization of Pseudomonas-CSP Research Cell Bank (RCB) (Stage 3); SAIC now requires Pfenex to develop a manufacturing process suitable for a scale up, at a minimum, of a [*] fermentation scale and follow-on purification for the SAIC selected clone CS533-129 and technical transfer of the process to a SAIC designated facility.

2.1. Stage 4: Fermentation Optimization of cell line CS533-129

 

    Pfenex shall optimize fermentation parameters for protein expression utilizing the RCB.

 

    The optimized fermentation shall be confirmed at the [*] scale.

 

    The optimized fermentation shall produce material which can be subsequently purified to meet product quality and safety specifications required for human use when produced under cGMP conditions.

 

    Pfenex shall submit the optimized fermentation procedure/protocol to SAIC for review and approval.

 

    Document shall also contain, at a minimum, in process parameters examined, rational for parameters selected, and copies of the raw data.

2.2. Stage 5: Purification Process Development

 

    Pfenex shall examine, choose, and optimize a final method for [*]

 

    The primary recovery procedure shall produce material which can be subsequently purified to meet product quality and safety specifications required for human use when produced under cGMP conditions.

 

    Pfenex shall select and submit an optimal method to SAIC for review and approval.

 

    Document shall also contain, at a minimum, methods examined, rational for method selected, and copies of the raw data.

 

    Pfenex shall develop a downstream purification process based on lessons learned from Stage 2A (CSP research-grade purification strategy).

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

1


    In-process recovery of CSP shall be calculated and monitored.

 

    Pfenex shall utilize a buffer system that is suitable for the solubility and stability of the purified CSP; and that the buffer system shall meet product quality and safety specifications required for human use when produced under cGMP conditions.

 

    Pfenex shall summit the developed purification process procedures and protocols to SAIC for review and approval before moving forward to engineering run ( Stage 7 ).

 

    Document shall also contain, at a minimum, processes examined, rational for processes selected, and copies of the raw data.

 

    Pfenex shall ship all purified CSP generated during development to a SAIC designated facility; however, Pfenex may retain up to 10% of the material produced if necessary.

2.3. Stage 6: Product Specific Analytical Method Development

 

    Pfenex shall develop and qualify product specific in-process and final product analytical methods and provide standard operating procedures (SOPs) for each method.

 

    For release testing of bulk drug substance, the testing shall include but not be limited to, [*]

 

    For characterization of bulk drug substance, the testing shall include but not limited to [*]

 

    Pfenex shall establish acceptance criteria and specifications in consultation with SAIC, where applicable, that will be the basis for release and stability monitoring. The specifications shall be appropriate for a phase 1 clinical product.

 

    Pfenex shall recommend and submit the developed analytical and characterization testing, including procedures, protocols, and their results, to SAIC for review and approval.

2.4. Stage 7: Engineering Run

 

    Pfenex shall perform [*] to ensure reproducibility of previously drafted procedures.

 

    Pfenex shall develop master batch production records (BPRs) for the first engineering run that cover all of upstream and downstream process, and identifies where the in-process tests occur and what volume is removed for testing. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

    Pfenex shall develop master BPRs for the second engineering run that cover all of upstream and downstream process and identifies where procedures are modified, if any. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

    Pfenex shall submit the completed BPRs to SAIC upon the completion of each engineering run.

 

    Pfenex shall execute the release and characterization testing as accomplished in Stage 6 for the engineering run material.

 

    Pfenex shall set aside aliquots for the stability program described below, and ship the remaining purified CSP from the engineering runs to a SAIC designated facility in aliquots to be determined at a later timepoint.

2.5. Stage 8: Stability Program

 

    Pfenex shall conduct a non-GMP stability monitoring of the purified CSP. Pfenex shall submit the stability monitoring plans for both engineering runs to SAIC for review and approval.

 

    The stability of purified CSP from the engineering runs shall be evaluated for stability at conditions of [*]

 

    Stability monitoring assessment shall include, at minimum, [*]

 

    A stability report shall be submitted to SAIC at each stability timepoint and include, at minimum, assays utilized with associated SOP, test results in table format, conclusion, trending data, and copies of raw data.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

2


2.6. Stage 9: Process Training and Transfer

 

    Pfenex shall train SAIC’s clinical contract manufacture organization (CMO) on the manufacturing process and shall transfer the BPRs (master and completed) and analytical method SOPs.

 

    As part of the process training and transfer Pfenex shall conduct at least one successful training run.

 

    The process yield from the process training run shall be within acceptable scientific variation from the 2 engineering runs performed in Stage 7. The purified CSP shall have purity [*]

 

    The process training run shall demonstrate reproducibility in all up- and down-stream processes including, but not limited to, growth rate in fermentation, quantity and quality of CSP in lysate, in primary recovery, in each process step, and in final product.

 

    Pfenex shall provide to SAIC and to SAIC designated CMO the RCS and a full process transfer package with all information necessary for the transfer of the manufacturing process.

 

    The full process transfer package shall be applicable for a scale up, at a minimum, [*] and follow-on purification, upon transfer.

 

    The full process transfer package shall include, but is not limited to, the following items:

 

    Bill of materials and suggested suppliers

 

    Detailed fermentation and purification process procedures (master BPRs)

 

    Listing of instruments/equipment

 

    Detailed testing procedures (SOPs)

 

    Technical specification for the bulk drug substance

 

    Health/Safety/Environment assessment of all materials and process

 

    Detailed characterization of purified protein/buffer and intermediates

 

    Stability testing plan and final report

 

    Research cell bank growth parameters and technical information

 

    Construct expression information and test results

 

    The process transfer and associated training records for the transfer to the clinical CMO shall be well documented and be provided to SAIC in the final report.

2.7. Final Report

 

    Pfenex shall issue a final report covering all of the process development and process transfer efforts. The report shall include an executive summary, brief description of methods, results, and conclusions pertaining to all process development activities, technical transfer training records and report, inventory of reagents provided by SAIC, and raw data in PDF format.

 

    The final report shall also contain sufficient data for use in the CMC section of the IND submission including, but not limited to, details of the cloning and development of the expression strain CS533-129.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

3


3. Quality Requirements

In addition to the Quality Requirements stated in the SOW, Pfenex shall execute a Quality Management Plan suitable for process development and technical transfer (see Section 10).

 

  3.1. Pfenex shall provide a scientific, technical, and administrative infrastructure to ensure quality control of all process development and technical transfer activities.

 

  3.2. The quality management plan shall include use of any materials, instruments/equipment, methods, procedures utilized in the process development and technical transfer.

 

  3.3. At a minimum, Pfenex shall ensure:

 

    Facilities in which SAIC’s materials are maintained in a safe and secure manner and allow limited access.

 

    Personnel have the necessary education and training in all procedures relevant to work assignments; training and qualifications are verified by leadership of Pfenex.

 

    SOPs will be used to document policies and procedures. SOPs will be version controlled and approved by key personnel.

 

    An effective tracking/tracing system or procedure is in place for all materials and equipment used in this contract.

 

    Equipment calibration and maintenance are performed as required and are documented.

 

  3.4. The Quality management plan shall govern Pfenex’s commitment to quality and ensure that procedures addressing the following requirements are in place.

 

    SOPs

 

    Document/version control

 

    Equipment maintenance and repair

 

    Training: adherence of staff to required schedules

 

    Data management

 

    Record management system

 

    Safety plan

 

    Asset tracking and management

 

    Building and facility monitoring

 

    Adherence to Federal or other applicable regulatory requirements appropriate for work on this contract

 

    Operational deviations and failures will be investigated through root cause analysis, which will be documented.

 

  3.5. Cold/frozen and controlled temperature storage chambers have continuous monitors with alarms or are monitored at least every 4 hours by security staff. Any deviations will be immediately reported to Pfenex staff.

 

  3.6. Effective cold chain management practices are in place for the handling of materials, products and samples.

 

  3.7. Investigation are initiated upon incident discovery (excursion from written procedure, policy, or protocol). Upon request, copies results of investigations are submitted to SAIC for review.

 

  3.8. SAIC may schedule in-plant and other visits at Pfenex to audit quality of activities conducted in this contract.

 

4. Record Management Requirements

Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan).

 

  4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

4


  4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results.

 

  4.3. Record and document security systems shall be adequate to ensure confidentiality and privacy of proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC.

 

  4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP.

 

  4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site.

 

  4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer.

 

  4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request.

 

5. Table 1. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Technical    purified CSP from process development    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
2    Technical    purified CSP from engineering and training runs    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
3    Technical    Unused reagents provided by SAIC    Within 2 weeks of SAIC request    Sent to SAIC designee in proper shipping containers
4    Technical    fermentation      
5    Technical         
6    Technical          PDF or Word document
7    Technical          PDF or Word document
8    Technical          PDF or Word document
9    Technical          PDF or Word document
10    Technical          PDF or Word document
11    Technical          PDF or Word document
12    Technical          PDF or Word document
13    Technical          PDF or Word document
14    Technical          PDF or Word document
15    Reporting          Telecom
16    Reporting          PDF or Word document

 

* Days = Calendar days

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

5


LOGO

SUBCONTRACT AGREEMENT

FIRM FIXED PRICE COMMERCIAL ITEMS (GOVERNMENT)

Modification 06

 

SUBCONTRACTOR:   SUBCONTRACT #:    P010022290
Pfenex Inc.   MODIFICATION #:    06
ADDRESS:   DPAS RATING:    Not Rated
10790 Roselle Street San Diego, CA 92121   TYPE:   

FIRM FIXED PRICE COMMERCIAL

 

ITEMS (GOVERNMENT)

 

VALUE:

FUNDED:

  

$4,055,873.00

$2,640,928.02

The purpose of this modification is to add subcontract value, incremental funding and a Statement of Work, dated May 2, 2011, entitled “Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™ and Process Manufacturing. The modification results from Pfenex Inc’s proposal, dated May 11, 2011. As a result, the award value is increased from $3,093,173.00 by $962,700.00 to $4,055,873.00.

Article 1.0 PRICE is modified to read as follows:

The total not-to-exceed PRICE of Subcontract No. P010022290 is increased by $962,700.00 from $3,093,173.00 to $4,055,873.00 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2011. The total FUNDING of Subcontract No. P010022290 is increased by $327,800.00 from $2,313,128.02 to $2,640,928.02 including profit.

Article 1.3 INVOICES is modified to read as follows:

Invoices shall contain the following information: subcontract number, subproject number, Stage #. Invoices may be mailed or emailed to:

Science Applications International Corporation

Attention: Michael A. Younkins

5202 Presidents Court, Suite 110

Frederick, Maryland 21703

Michael.A.Younkins@saic.com

Article 2.0 TECHNICAL AND CONTRACTUAL POINTS OF CONTACT is modified to replace Earleen Smith with the following:

SAIC (BUYER):

Contractual: Michael A. Younkins

Article 1.4 PAYMENT — is modified to read as follows:

(a) Original Subcontract Award: For each Stage of work there will be two invoices each totaling 50 % of the price for each Stage of Work, an initial invoice upon commencement of the Stage and a final invoice upon acceptance of the final report for each Stage.

Subcontract Modification #2: For each of the two Milestones in the Statement of Work dated May 4, 2010 (modification #2) there will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

Subcontract Modification #4: For each of the two Milestones in the Statement of Word dated November 15, 2010 (modification #4) there will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 5


LOGO

 

 

Subcontract Modification #5: The table shown in Mod #5 shall be utilized for Milestone Invoice dates of submission and Invoice Amounts for the Milestones defined in the Statement of Work dated December 13, 2010 (modification #5). There will be two invoices each totaling 50% of the price for each Milestone, an initial invoice upon commencement of the Milestone and a final invoice upon acceptance of the final report and associated deliverables for each Milestone.

Subcontract Modification #6: The following table shall be utilized for Milestone Invoice submission:

(see next page)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 5


LOGO

 

 

Milestone

  

Payment

  

Amount

  

Duration

Antigen 1 & Antigen 2 Milestone 1   

50% upon

commencement

   $ [*]   

Approximately 8 weeks from

receipt of synthetic genes

 

Antigen 1 & Antigen 2 Milestone 1

  

 

50% upon delivery of

report

   $ [*]   
Antigen 1 Milestone 2 [OPTIONAL]: Fermentation Assessment of [ * ] in Pfēnex Expression Technology™   

50% upon

commencement

   $ [*]   

Approximately 6 weeks from

receipt of written

authorization to proceed

 

Antigen 1 Milestone 2 [OPTIONAL]: Fermentation Assessment of [ * ] in Pfēnex Expression Technology™

  

 

50% upon delivery of

report

   $ [*]   
Antigen 2 Milestone 2 [OPTIONAL]: Fermentation Assessment of [ * ] in Pfēnex Expression Technology™   

50% upon

commencement

   $ [*]   

Approximately 6 weeks from

receipt of written

authorization to proceed

 

Antigen 2 Milestone 2 [OPTIONAL]: Fermentation Assessment of [ * ] in Pfēnex Expression Technology™

  

 

50% upon delivery of

report

   $ [*]   
Antigen 1 Milestone 2A [Optional]: [ * ] pure [ * ] protein from 3 selected [ * ] clones respectively to SAIC   

50% upon

commencement

   $ [*]   

Approximately 7 weeks from

receipt of written

authorization to proceed

 

Antigen 1 Milestone 2A [Optional]: [ * ] pure [ * ] protein from 3 selected [ * ] clones respectively to SAIC

  

 

50% upon delivery of

report

   $ [*]   

 

Antigen 2 Milestone 2A [Optional]: [ * ] pure [ * ] protein from 3 selected [ * ] clones respectively to SAIC

  

 

50% upon

commencement

   $ [*]   

 

Antigen 2 Milestone 2A [Optional]: [ * ] pure [ * ] protein from 3 selected [ * ] clones respectively to SA IC

  

 

50% upon delivery of

report

   $ [*]   
Antigen I Milestone 3 [OPTIONAL]: Preparation and Characterization of a P. fluorescens- [ * ] Research Cell Bank (RCB)   

50% upon

commencement

   $ [*]   

Approximately 4 weeks from

receipt of written

authorization to proceed

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 3 of 5


LOGO

 

Antigen 1 Milestone 3 [OPTIONAL]: Preparation and Characterization of a P. fluorescens- [ * ] Research Cell Bank (RCB)   

50% upon delivery of

report

   $ [*]   
Antigen 2 Milestone 3 [OPTIONAL]: Preparation and Characterization of a P. fluorescens- [ * ] Research Cell Bank (RCB)   

50% upon

commencement

   $ [*]   

Approximately 4 weeks from

receipt of written

authorization to proceed

 

Antigen 2 Milestone 3 [OPTIONAL]: Preparation and Characterization of a P. fluorescens- [ * ] Research Cell Bank (RCB)

  

50% upon delivery of

report

   $ [*]   

(b) Payment terms will be Net 45 days from date of invoice. Upon receipt of invoice Buyer shall within five (5) business days review the invoice and determine if the invoice is acceptable. If Buyer reasonable deems the invoice unacceptable Buyer shall contact Seller and Seller shall reissue a conforming invoice with a new date of invoice. If (1) Buyer does not pay on time or (2) Buyer’s financial responsibility becomes unsatisfactory (S&P rating below BBB- or Moody’s rating below Baa3) to Seller and Seller deems itself insecure, Seller may accelerate the due date and demand immediate payment on any outstanding invoice for Product, or may require cash payments or satisfactory security for future deliveries and for payment of all sums owed under this Agreement. Buyer agrees to pay all costs and expenses, including reasonable attorney’s fees, incurred by Seller in the collection of any sum payable by Buyer to Seller, or in the exercise of any remedy. Pfenex may charge Prime +2% on all overdue amounts.

Article 17.0 ORDER OF PRECEDENCE — is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

1. Attachment I: Statement of Work and Schedule dated May 11, 2011

 

2. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

3. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

4. Attachment C (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls

 

5. Attachment II: Statement of Work and Schedule dated July 2009, Subcontract Modification #2 dated May 4, 2010, Subcontract Modification #4 dated November 15, 2010 and Subcontract Modification #5 dated January 1, 2011.

All other Subcontract terms and conditions remain unchanged.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 4 of 5


LOGO

 

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Michael A. Younkins

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Michael A. Younkins

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

May 25, 2011

    Date:  

6/1/2011

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 5 of 5


STATEMENT OF WORK

Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™

And Process Manufacturing

Malaria Vaccine Production and Support Services

May 2, 2011

Subcontract Modification 6

 

1. Scope of Work

Independently and not as an agent of SAIC, P f ēnex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the proof-of-principle evaluation of expressing full-length and functional [*], suitable for use with [*] in combination vaccines, utilizing P f ēnex Expression Technology™. P f ēnex shall provide antigens, cell banks, and reports and other documentation related to the development and manufacturing process, as required in the deliverables (Table 1). Milestones in this subcontract modification include:

 

Antigen

  

Milestone

CeITOS    Milestone 1: Evaluation of [*] expression in Pfēnex Expression Technology™
  

 

Milestone 2 [OPTIONAL]: Fermentation Assessment of [*] in Pfēnex Expression Technology™

  

 

Milestone 2A [Optional]: Provide [*] pure [*] protein from 3 selected [*] clones respectively to SAIC

  

 

Milestone 3 [OPTIONAL]: Preparation and Characterization of a Pseudomonas -[*] Research Cell Bank (RCB)

TRAP    Milestone 1: Evaluation of [*] expression in Pfēnex Expression Technology™
  

 

Milestone 2 [OPTIONAL]: Fermentation Assessment of [*] in Pfēnex Expression Technology™

  

 

Milestone 2A [Optional]: Provide [*] pure [*] protein from 3 selected [*] clones respectively to SAIC

  

 

Milestone 3 [OPTIONAL]: Preparation and Characterization of a Pseudomonas -[*] Research Cell Bank (RCB)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

1


SAIC will provide the following information and materials:

 

  1.1. Background literature/references relating to [*].

 

  1.2. Suitable reference materials and sera relating to [*] if available.

 

2. Period of Performance

The period of performance (POP) for this effort is upon award through September 2014.

 

3. Technical Requirements

 

  3.1. Milestone 1: Evaluation of [*] expression in P f ēnex Expression Technology™

 

  3.1.1. P f ēnex shall clone and express a synthesized full-length [*] gene sequences (minus the GPI sequence) in P f ēnex Expression Technology™.

 

  3.1.1.1. The coding region for the [*] from Pf strain [*] shall be optimized, synthesized, and cloned into a minimum of [*] different P f ēnex expression vectors.

 

  3.1.1.2. P f enex shall transform the resulting plasmids into a strain of P f ēnex Expression Technology™ and plate onto selective medium.

 

  3.1.1.3. P f ēnex shall select a series of positive clones from assorted vectors and verify correct coding sequences of insert.

 

  3.1.2. P f ēnex shall assess the expression of [*] in P f ēnex Expression Technology™ at [*] scale in a minimum of [*] unique strains

 

  3.1.2.1. P f ēnex shall transform the resulting plasmids into up to [*] selected host strains. (A minimum of [*] unique Expression Strains)

 

  3.1.2.2. P f ēnex shall perform [*] as a primary screen.

 

  3.1.2.3. P f ēnex shall verify the target band on [*] (if antibody is available), and [*].

 

  3.1.3. P f ēnex shall issue a final report of milestone 1 efforts.

 

  3.1.3.1. Report shall include an executive summary, brief description of test method with a reference to corresponding SOP, test results (i.e. small scale growth, expression, analytical), and conclusion. Copies of raw data including sequencing data shall be included as an appendix.

 

  3.2. Milestone 2 [OPTIONAL]: Fermentation Assessment of [*] in P f ēnex Expression Technology™

 

  3.2.1. P f ēnex shall screen multiple fermentation conditions at the [*] scale using [*] Expression Strains to evaluate protein quality and expression levels

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

2


  3.2.1.1. Execute experiments to screen multiple fermentation conditions in mini-bioreactors for protein expression and protein quality. ([*] fermentations per strain)

 

  3.2.1.2. P f ēnex shall perform [*] analysis on samples from each of the fermentations.

 

  3.2.1.3. P f ēnex shall verify the target band and its solubility on [*]

 

  3.2.2. P f ēnex shall confirm selected conditions used at the [*] scale and verify conditions are suitable at the high cell density fermentation [*] scale to evaluate protein quality and expression levels of selected strains chosen based on data generated in 3.2.1.3.

 

  3.2.2.1. P f ēnex shall confirm selected conditions and strains identified in the screening experiments in a scalable high cell density fermentation process in multiplex fermentors for protein expression and protein quality.

 

  3.2.2.2. P f ēnex shall collect multiple time point samples for evaluation of protein expression levels and quality

 

  3.2.2.3. P f ēnex shall utilize a [*] method as appropriate to prepare samples from the best fermentation of each expression strain for supply to SAIC.

3.2.2.3.1. P f ēnex shall transfer to SAIC samples of the filtered whole cell lysate or periplasmic release extract and cell free broth for further in vitro analysis.

3.2.2.3.2. P f ēnex shall perform [*] on samples from each fermentation.

3.2.2.3.3. P f ēnex shall verify the target band and its solubility on [*]

 

  3.2.3. P f ēnex shall issue a final report of milestone 2 efforts.

 

  3.2.3.1. Report shall include an executive summary, brief description of test methods with associated reference to SOPs, data (i.e. small scale growth, expression, analytical), and conclusion. Copies of raw data shall be included as an appendix.

 

  3.3. Milestone 2A [Optional]: Provide [*] pure [*] protein from [*] selected [*] clones respectively to SAIC

 

  3.3.1. Pfenex shall evaluate up to four [*] to capture [*] protein using batch binding experiments in 96-well plate format.

 

  3.3.2. Pfenex shall conduct small scale capture chromatography runs using up to two selected [*] to evaluate purification of [*] protein.

 

  3.3.3. Pfenex shall conduct small scale secondary chromatography runs using up to two selected [*] using elution pool from the primary capture column runs.

 

  3.3.4. Pfenex shall evaluate up to [*] for reduction of [*].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

3


  3.3.5. Pfenex shall analyze the final purified proteins and the filtered lysate using analytical methods including [*]

 

  3.3.5.1. Pfenex shall assess the difference in endotoxin level between filtered lysate and purified [*]

 

  3.3.5.2. Pfenex shall also assess the conformational integrity of the purified [*]

 

  3.3.6. If the quality and purity of purified protein is deemed acceptable by SAIC for R&D non-clinical studies, Pfenex shall ship the resulting purified [*] protein ([*]) from [*] selected [*] clones to SAIC.

 

  3.4. Pfenex shall issue a final report of purification efforts.

 

  3.4.1. Report shall include an executive summary, brief description of methods, results and conclusions, inventory of reagents provided by SAIC, and raw data in PDF format.

 

  3.5. Milestone 3 [OPTIONAL]: Preparation and Characterization of a Pseudomonas- [*] Research Cell Bank (RCB)

Pfenex shall prepare a non-GMP Research Cell Bank (RCB).

 

  3.5.1. Pfēnex shall generate [*] vials of RCB

 

  3.5.2. Pfēnex shall store the RCB a temperature-controlled -80°C freezer which has a monitoring system.

 

  3.5.3. A [*] scale fermentation run shall performed to confirm productivity

 

  3.5.3.1. Pfēnex shall harvest and prepare filtered lysate from the [*] fermentation ([*] working volume)

 

  3.5.3.2. Plasmid retention shall be evaluated using viable count plating of the samples on selective and non-selective media.

 

  3.5.3.3. Structural stability shall be evaluated using plasmid restriction digests.

 

  3.5.4. Pfēnex shall perform a characterization analysis of the generated Pseudomonas -[*]

 

  3.5.4.1. Phenotype of the strain shall be determined by plating on [*]

 

  3.5.4.2. Culture purity analysis shall be performed on the RCB.

 

  3.5.4.3. [*]

 

  3.5.4.4. Pfēnex shall confirm the [*]

 

  3.5.5. Pfenex shall issue a final report of milestone 3 efforts.

 

  3.5.5.1. Report shall include, but no be limited to, an executive summary, description of cell banking methods and materials used, with associated reference to SOPs, characterization data, raw material certificates of analysis, and copies of raw data.

 

  3.5.5.2. A draft report shall be submitted to SAIC two weeks following completion of task and a final copy submitted one week following SAIC comments.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

4


4. Quality Requirements

Pfenex shall maintain a Quality System that meets scientific expectations of traceability, reliability and control. Pfenex shall be responsible for the development and demonstration of suitability of contracted deliverables as well as providing reports and managing this project in a manner that meets scientific expectations of traceability, reliability and control ensuring that the filtered whole cell lysate or periplasmic release extract and cell free broth produced and analyzed in the developed process and assays have the quality, and identity they purport.

 

5. Meeting and Conference Requirements

Unless an alternative directive is provided; meeting, conference, and audit support shall include the following:

 

  5.1. Pfēnex shall schedule a kickoff meeting via on-site meeting with SAIC within 7 days of award. The agenda shall be provided by Pfenex in advance. The purpose of the kickoff meeting is formal introduction of key staff and project management, technical and contractual discussions, and initial action items required to initiate contract work.

 

  5.2. Pfēnex shall participate in biweekly meetings and/or teleconferences with SAIC. Such meetings may include, but are not limited to, meetings to discuss the technical (e.g., assay designs and critical reagents), quality, schedule, regulatory, and contractual aspects of the program and site visits to Pfenex’s facilities. All visits to Pfēnex’s facility shall be prearranged. Pfēnex shall be responsible for preparing meeting agendas and summaries. Meeting minutes shall be captured by Pfēnex and are due to SAIC within 7 days after the completion of a biweekly teleconference.

 

  5.3 Pfēnex also shall be available for ad hoc support (e.g., phone calls and e-mails) to SAIC as required for project communications.

 

6. Reporting Requirements

 

  6.1. Monthly Technical and Business Progress Report: A monthly TPR shall be submitted to the SAIC management point of contact by the eighth of each month during subcontract POP.

 

  6.1.1. The TPR shall cover the work accomplished as well as issues and proposed resolutions that occur during each reporting period.

 

  6.1.2. Each TPR also shall contain an updated monthly project management schedule to indicate work completed and any change in schedule. Deliverables shall be incorporated into the schedule.

 

  6.2. Reports should include an updated inventory log, and a notice of any temperature deviations of equipment storing SAIC material. The report shall also document any changes made to methods and procedures utilized for the cloning and expression efforts.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

5


  6.2.1. Report shall include invoicing information for work performed during each reporting period and anticipated work activities.

 

  6.3. Documentation to Support an IND or Amendment: Data generated under this subcontract may be incorporated into an FDA submission. Pfenex shall provide a list of relevant SOPs or other control, development and testing documents as requested.

 

7. Subcontract Deliverables

Table 3 summarizes documents and other deliverables due to SAIC at the indicated timelines.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

6


Table 1. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Project
Management
  

Final Project

Schedule

   To be submitted within 1 week of kickoff meeting; schedule to be baselined within 3 weeks of award    1 electronic file, Preferably .mmp
format
2    Meeting
Requirement
  

Meeting

Agenda

   1 day prior to regular meetings, 3 days prior to kickoff   

1 electronic Word

document or

email

3    Meeting
Requirement
  

Meeting

Summaries

   7 days after meetings   

1 electronic Word

document

4    Technical
Requirement
  

Milestone
Reports

[if funded]

  

Draft: 2 weeks following completion of procedure

Final: 2 weeks after receipt

of SAIC comments

  

Draft: Word
Document

Final: Signed PDF

8    Technical
Requirement
  

Antigen

deliverables

  

2 weeks following

completion of requirement.

  

Sent to SAIC
designee in

proper shipping

containers

 

* Days = Calendar days; SAIC shall provide comment within 1 week.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

7


Core B. Carrier Protein Production

P.I. Pfenex, Inc. San Diego, CA

Project Summary

The overall goal of the Core is to express and produce carrier proteins for conjugation to [*] discovered in Projects 1 and 2. Special emphasis will be on the production of [*] containing strategically inserted [*] to serve as anchors for targeted attachment of [*] and [*]. We expect that such an immunogen with a focused [*] will have a better chance of eliciting neutralizing antibodies than the [*] with its unpredictable host-dependent glycan shield. In order to eliminate any other [*], we will express [*] in a [*] protein expression system. Further we will incorporate [*] at the sites of [*] to enable targeted attachment of synthetic [*] at correct sites.

Attempts to express [*] in E. coli has been difficult, generally resulting in production of insoluble material that refolds with very poor yields. The Pfenex Expression Technology™ platform represents a new paradigm of microbial strain development that overcomes the slow iterative process of strain selection and high failure rates for protein production in E. coli. Pfenex has developed a proprietary strain of P.fluorescens specifically as a protein production platform to enable rapid development of expression strains capable of expressing high titers of soluble, active protein. Using a combinatorial matrix of expression plasmids and host strains, along with high throughput methods for growth and analysis of expression strain candidates, identification of a production strain and development of a first fermentation process can be achieved rapidly. Importantly, yields of soluble protein of ~ 1 gram per liter can be achieved upon optimization of fermentations conditions. Initial expression studies (Aim1) will be done using the codon-optimized sequence of the [*] from the [*] as it has been shown to express epitopes recognized by each [*]. Next (Aim2), we will express [*] incorporating [*] at positions of [*] attachment such as positions [*]. This will enable attached of synthetic [*] at specific locations on [*] as part of Project 2. Subsequent studies will use [*], as required.

Core B Specific Aims

Aim 1. Efficiently express select [*] proteins in a prokaryotic system to produce non-glycosylated carrier proteins for elicitation of enhanced [*] responses

Codon optimized [*] genes will be cloned into [*] unique plasmids, which will be transformed into [*] unique host strain backgrounds resulting in a total of [*] unique expression strains. Following the small scale expression, Pfenex will perform analytical testing on the product produced from each of the Expression Strains, including [*]. Furthermore, Pfenex will scale up production and purification of selected strains and provide purified protein for Projects 1, 2, and 3.

 

  1.1 Develop P.fluorescens strains that efficiently express [*]

 

  1.2 Develop P. fluorescens strains for efficient production of [*]

 

  1.3 Scale up and purifiy [*] from above aims to provide ~ 1 gram of each protein to Projects 1, 2 and 3

 

  1.4 Produce ~ 1 gram of [*] for use as a carrier protein for Project 1 and for use as a control for experiments in Project 2

Aim 2. Efficiently express select [*] proteins in Pseudomonas fluorescens to produce soluble [*] proteins containing [*].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

1


Codon optimized DNA designed to insert [*] known to be critical for binding to[*] will be cloned into [*] unique plasmids, which will be transformed into [*] unique host strain backgrounds resulting in a total of [*] unique expression strains. Following the small scale expression, Pfenex will perform analytical testing on the product produced from each of the Expression Strains, including [*]. Emphasis will be placed on selection of strains that secrete high quantities of protein into the periplasmic space to facilitate purification. Three – five high-producer strains will be selected for scale up production and purification to provide [*] for Projects 2 and 3.

 

  2.1 Develop P.fluorescens strains that efficiently express [*]

 

  2.2 Scale up and purify [*] from strains developed in Aim 2.1 to provide ~ 1 gram of protein to support Projects 2 and 3.

Research Plan

Significance. The development of a vaccine to prevent AIDS is the best hope for controlling the epidemic that has led to infection of more than 30 million people with the HIV-1 virus worldwide. A vaccine approach that reduces viral load would certainly be beneficial, but one that elicits sterilizing immunity would be preferred. Conventional vaccine approaches based on delivery of HIV-1 envelope (Env) proteins or peptides derived from Env sequences have failed to generate broadly neutralizing antibodies (bNAbs) to the virus, which mutates rapidly to escape from the immune response. Recently, [*] have been discovered from subjects in the [*]. Several of these antibodies, including [*] determinants alone or in the context of the [*] protein. Importantly, these antibodies are even more potent (i.e., they neutralize HIV-1 at lower antibody concentrations) than other newly discovered [*]. Immunogens that elicit antibodies similar to the [*] could be ideal vaccine candidates.

(b) Innovation. The HIV-1 Env is shrouded with oligomannose glycans that obscure potential neutralization sites and prevent the elicitation of broad and potent immune responses. Partial removal of glycans has been shown to improve the immunogenicity of [*]. From a practical perspective, [*] are notoriously difficult to express in abundance in either mammalian or prokaryotic systems. In mammalian expression systems, yields of only 10-20µg per liter are common, and in E. coli expression results mainly in the production of insoluble material that is difficult to refold. Furthermore, glycosylation patterns in proteins derived from biological production systems are typically highly variable whereas using synthetic chemical methods we can obtain pure glycans in a manner that may be scaled for ultimate large scale production.

Our overall goal is to discover and develop an [*] exposure and targeted synthetic glycan modifications to elicit broadly neutralizing glycoprotein-specific immune responses. Specifically, we will employ the new broad and potent antibodies [*], which bind [*]. These sugar-binding antibodies require [*] and appear to require the [*] on the [*]. We plan to prepare vaccines that contain a constrained synthetic glycan attached specifically to [*] at the site of native [*]. The critical innovation required to meet this goal is the production of a large quantity (~ 1 gram) of soluble [*]. The Pfenex Expression System has the following unique properties that will ensure a high probability of success that will enable us to meet the above requirements:

Please list attributes…

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

2


(c) Approach.

Show steps involved in production of [*] as “preliminary data” to describe how you will approach the production of [*]

It is expected that our approach will elicit an immune response to [*] as well as to protein epitopes normally concealed by endogenous glycans. We recognize that this could have the mixed benefit of focusing the antibody response on the linked glycan while potentially diverting the immune response to non-neutralizing epitopes. However, efforts to eliminate non-neutralizing protein epitope by, for example, eliminating V loops, has not proven to be beneficial in focusing the immune response on neutralizing epitopes. Rather than trying to limit induction of non-neutralizing epitope, our approach it to stimulate a robust antibody response to the entire immunogen, especially to the glycans presented in the [*]. Glycoconjugate vaccines such as Prevnar (for the prevention of pneumococcal diseases) have been extremely successful in reducing invasive pneumococcal disease in humans despite induction of strong immune responses to the carrier protein.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

3


LOGO

SUBCONTRACT AGREEMENT

Modification 07

 

SUBCONTRACTOR:

 

Pfenex Inc.

   SUBCONTRACT #:    P010022290
  

 

MODIFICATION #:

  

 

07

ADDRESS:

 

10790 Roselle Street

San Diego, CA 92121

   DPAS RATING:    Not Rated
  

 

TYPE:

  

 

FIRM FIXED

PRICE COMMERCIAL

ITEMS (GOVERNMENT)

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

VALUE:

FUNDED:

  

$4,055,873.00

$2,640,928.02

The purpose of this modification is to extend the period of performance, at no additional cost, FROM Sep 11, 2009 through Sep 21, 2011 TO Sep 11, 2009 through Sep 21, 2014. The total value and funding value remain unchanged at $4,055,873 and $2,640,928.02 respectively. The address for Pfenex, Inc. is revised to that shown above.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX, INC.     SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Michael A. Younkins

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Michael A. Younkins

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

9/9/11

    Date:  

9/9/11

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

SUBCONTRACT AGREEMENT

Modification 08

 

SUBCONTRACTOR:

 

Pfenex Inc.

   SUBCONTRACT #:    P010022290
  

 

MODIFICATION #:

  

 

08

ADDRESS:

 

10790 Roselle Street, San Diego, CA 92121

   DPAS RATING:    Not Rated
  

 

TYPE:

  

 

FIRM FIXED PRICE COMMERCIAL

 

ITEMS (GOVERNMENT)

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

VALUE:

FUNDED:

  

$4,055,873.00

$2,863,328.02

The purpose of this modification is to provide incremental funding in the amount of $222,400.00. As a result, the funding value is increased FROM $2,640,928.02 BY $222,400.00 TO $2,863,328.02. The total value remains unchanged at $4,055,873.00.

Article 1.0 PRICE is modified to read as follows:

The total not-to-exceed PRICE of Subcontract No. P010022290 is $4,055,873.00 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $2,863,328.02 including profit.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Michael A. Younkins

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Michael A. Younkins

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

09/29/2011

    Date:  

09/29/2011

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

SUBCONTRACT AGREEMENT

Modification 09

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290
Pfenex Inc.    MODIFICATION#:    09
ADDRESS:    DPAS RATING:    Not Rated

10790 Roselle Street, San Diego, CA

   TYPE:    FIRM FIXED PRICE COMMERCIAL
92121      

 

ITEMS (GOVERNMENT)

Period of Performance:    VALUE:    $4,055,873.00

Sep 11, 2009 thru Sep 21, 2014

  

FUNDED

  

$3,135,328.02

The purpose of this modification is to provide incremental funding in the amount of $272,000.00. As a result, the funding value is increased FROM $2863,328.02 BY $272,000.00 TO $3,135,328.02. The total value remains unchanged at $4,055,873.00.

Article 1.0 PRICE is modified to read as follows:

The total not-to-exceed PRICE of Subcontract No. P010022290 is $4,055,873.00 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $3,135,328.02 including profit.

All other Subcontract terms and conditions remain unchanged

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX, INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Michael A. Younkins

(Signature)     (Signature)

Patrick Lucy

   

Michael A. Younkins

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

11-17-11

    Date:  

11-17-2011

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

SUBCONTRACT AGREEMENT

Modification 10

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290
Pfenex Inc.    MODIFICATION #:    10
ADDRESS:    DPAS RATING:    Not Rated
10790 Roselle Street, San Diego, CA 92121    TYPE:   

FIRM FIXED PRICE COMMERCIAL

     

 

ITEMS (GOVERNMENT)

Period of Performance:

   VALUE:    $4,055,873.00

 

Sep 11, 2009 thru Sep 21, 2014

   FUNDED:    $3,915,373.26

The purpose of this modification is to provide incremental funding in the amount of $780,045.24. As a result, the funding value is increased FROM $3,135,328.02 BY $780,045.26 TO $3,915,373.26. The total value remains unchanged at $4,055,873.00.

Article 1.0 PRICE is modified to read as follows:

The total not-to-exceed PRICE of Subcontract No.P010022290 is $4,055,873.00 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No.P010022290 is $3,916,373.26 including profit.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Michael A. Younkins

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Michael A. Younkins

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

December 12, 2011

    Date:  

12/13/11

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

SUBCONTRACT AGREEMENT

Modification 11

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

   MODIFICATION #:    11
  

 

DPAS RATING:

  

 

Not Rated

  

 

TYPE:

  

 

FIRM FIXED PRICE

   COMMERCIAL ITEMS (GOVERNMENT)
Period of Performance: Sep 11, 2009 thru Sep 21, 2014   

VALUE:

FUNDED:

  

$4,171,178.75

$4,030,679.01

The purpose of this modification is to increase the total award value by $115,305.75 for additional work; Stage 5A/ Preliminary [*]. As a result of this modification, the total value is increased FROM $4,055,873.00 BY $115,305.75 TO $4,171,178.75. The total funded amount is increased FROM $3,915,373.26 BY $115,305.75 TO $4,030,679.01.

Statements of Work entitled “[*], November 21, 2011, Subcontract Modification 11” are herein incorporated into and made part of Subcontract No. P010022290.

Article 1.0 PRICE is modified to read as follows:

The total not-to-exceed PRICE of Subcontract No. P010022290 is $4,171,178.75 including profit. This subcontract is incrementally funded for work to be performed through March 21, 2014. The total FUNDING of Subcontract No. P010022290 is $4,030,679.01 including profit.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Michael A. Younkins

(Signature)     (Signature)
Name:  

Patrick Lucy

    Name:  

Michael A. Younkins

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

Date:  

12/21/11

    Date:  

1/3/12

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

November 8, 2011

Steve C. Huang, PhD, RAC, PMP

Project Manager

Science Applications International Corporation ( SAIC )

5202 Presidents Court

Suite 110

Frederick, MD 21703

Dear Steve,

Please find enclosed Pfenex Inc.’s proposal in response to SAIC’s Request for Proposal regarding the Preliminary Formulation Development of rCSP. The scope of work will be Contract Modification 11 to Subcontract #P010022290 related to SAIC Prime Contract # N01-AI-05421. The total Firm Fixed Price of this program in accordance with Statement of Work enclosed is $70,500 inclusive of materials cost.

This proposal is valid for 120 days from today’s date.

I look forward to working with you on this program.

 

Sincerely,
/s/ Patrick Lucy

Patrick Lucy

Vice President of Business Development & Marketing

Pfenex Inc.

301 Newbury Street PMB #251

Danvers, MA 01923

Tel. (978) 887-4971

PKL@Pfenex.com

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-1-


LOGO

STATEMENT OF WORK

Evaluation of Malaria CSP Expression in Pf enex Expression TechnologyTM

and Process Manufacturing

Malaria Vaccine Production and Support Services

November 11, 2011

Subcontract Modification

Stage 5A: Preliminary Formulation of rCSP

 

  1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the production of additional filtered lysates, and purified full-length CSP expressed in Pf enex Expression Technology TM . As part of this support, Pfenex shall be required to provide summary reports related to the preliminary formulation of rCSP.

 

  2. Technical Requirements

 

  2.1. Screen buffer Systems

 

  2.1.1. Pfenex shall evaluate at a minimum [*] that can accommodate concentrations of [*].

 

  2.1.1.1. Components/pH in the buffer systems should be suitable for human use.

 

  2.1.1.2. The buffer systems may include, but are not limited to the following.

 

No.

  

Buffer

  

pH

  

Tonicity

Modifier

  

Stabilizer

1

   [*]    [*]    [*]    [*]

2

   [*]    [*]    [*]    [*]

3

   [*]    [*]    [*]    [*]

4

   [*]    [*]    [*]    [*]

5

   [*]    [*]    [*]    [*]

 

  2.1.1.3. Compatibility of the buffer systems and CSP shall be analyzed. The methods that may include, but are not limited to, [*].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


LOGO

 

  2.2. Short term stability monitoring

 

  2.2.1. Upon selection of suitable buffer system(s) for [*], a short term stability shall be conducted to monitor the quality changes of [*] in the selected buffer systems.

 

  2.2.2. The short term stability shall include, but are not limited to, the following temperature and time points

 

Stress

   Conditions   Time Point(s)

Temperature

   [*]   [*]

 

  2.2.3. [*] quality in the selected buffer systems.

 

  2.2.4. At the minimum, one aliquot per temperature and per time point shall be assessed

 

  2.2.4.1. Testing methods for the CSP stability may include, but are not limited to, [*].

 

  2.2.5. Upon SAIC’s request, Pfenex shall provide [*] in the selected buffer system and concentration to SAIC for further testing

 

  2.3. Final Report

 

  2.3.1. Pfenex shall issue a final report.

The report shall include an executive summary, detailed description of methods including system suitability controls, list of all raw materials and their source, results, conclusions, inventory of reagents provided by SAIC, and all raw data in PDF format.

 

  3. Deliverables to SAIC

 

Deliverable

   Requirement    Item   

Date

  

Form

1

   Reporting    Final Report   

Draft: 2 weeks following completion

 

Final: 2 weeks after receipt of SAIC comments

  

Draft: Word Document

 

Final: Signed Pdf

2

   Technical    rCSP    Upon SAIC’s request    Proper shipping condition

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-3-


LOGO

 

 

  4. Cost Proposal

The pricing for the proposal shall be based upon commercial rates and is inclusive of costs for supplies, materials and reports. The pricing is broken down as follows:

Total Price – $[*]

Payment Terms – [*] upon delivery of final report.

Labor – Approximately [*] hours

Materials – $[*]

Timescale – Approximately eight (8) weeks from commencement to issuance of final report

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-4-


LOGO

 

November 21, 2011

Steve C. Huang, PhD, RAC, PMP

Project Manager

Science Applications International Corporation (SAIC)

5202 Presidents Court

Suite 110

Frederick, MD 21703

Dear Steve:

Please find enclosed Pfenex Inc.’s proposal in response to SAIC’s Request for Proposal regarding the Characterization of Fourteen (14) rCSP Monoclonal Antibodies. The scope of work will be Contract Modification 11 to Subcontract #P010022290 related to SAIC Prime Contract # N01-AI-05421. The total Firm Fixed Price of this program in accordance with Statement of Work enclosed is $45,000 inclusive of materials cost.

This proposal is valid for 120 days from today’s date. I look forward to working with you on this program.

Sincerely,

/s/ Patrick Lucy

Patrick Lucy

Vice President of Business Development & Marketing

Pfenex Inc.

301 Newbury Street PMB #251

Danvers, MA 01923

Tel. (978) 887-4971

PKL@Pfenex.com

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

 

STATEMENT OF WORK

Evaluation of Malaria CSP Expression in P f ēnex Expression TechnologyTM

and Process Manufacturing

Malaria Vaccine Production and Support Services

November 21, 2011

Subcontract Modification

Stage 6A: Characterization of 14 rCSP monoclonal antibodies

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the production of additional filtered lysates, and purified full-length CSP expressed in Pfēnex Expression TechnologyTM. As part of this support, Pfenex shall be required to provide summary reports related to the characterization of 14 of rCSP monoclonal antibodies (mAbs).

 

2. Technical Requirements

 

  2.1. [*]

 

  2.1.1. Pfenex shall characterize the provided [*] for their applications [*] and [*].

 

  2.1.1.1. In both [*] and [*], Pfenex shall screen [*] against the purified rCSP and its forced-degraded derivatives.

 

  2.1.1.2. For forced degradation, the purified rCSP shall be subjected to, but is not limited to, [*].

 

  2.1.1.3. Pfenex shall capture forced degradation conditions at which stability of the product can be reflected by the use of certain mAbs in [*].

 

  2.1.1.4. Forced-degraded derivatives of rCSP will also be analyzed by analytical methods that include, but is not limited to, [*].

 

  2.2. Final Report

 

  2.2.1. Pfenex shall issue a final report.

The report shall include an executive summary, detailed description of methods including system suitability controls, list of all raw materials and their source, results, conclusions, inventory of reagents provided by SAIC, and all raw data in PDF format.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

 

 

3. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date

  

Form

1

   Reporting    Final Report    Draft: 2 weeks following completion Final: 2 weeks after receipt of SAIC comments   

Draft: Word Document

Final: Signed PDF

2

   Technical    rCSP    Upon SAIC’s request    Proper shipping condition

 

4. Cost Proposal

The pricing for the proposal shall be based upon commercial rates and is inclusive of costs for supplies, materials and reports. The pricing is broken down as follows:

Total Price – $[*]

Payment Terms – [*] upon delivery of final report.

Labor – Approximately [*] – Included

Timescale – Approximately six (6) weeks from commencement to issuance of final report

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

 

SUBCONTRACT AGREEMENT

Modification 12

 

SUBCONTRACTOR:    SUBCONTRACT #:    P010022290

 

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

  

 

MODIFICATION #:

  

 

12

  

 

DPAS RATING:

  

 

Not Rated

  

 

TYPE:

  

 

FIRM FIXED PRICE

  

 

COMMERCIAL ITEMS (GOVERNMENT)

Period of Performance:

Sep 11, 2009 thru Sep 21, 2014

  

 

Modification Value:

  

 

$122,288.00

  

 

FUNDED:

  

 

$4,152,967.01

   Ceiling VALUE:    $4,612,816.75

The purpose of this modification is to increase the ceiling value by $441,638.00 and funding value by $122,288.00 for additional work as stated below.

Effective date of this modification is February 24, 2012.

Pfenex shall be required to provide (i) gene synthesis and strain engineering of PfRh5 in pseudomonas fluorecens, (ii) optimize fermentation for 1 L scale, (iii) purified 10mg protein from three selected clones, and (iv) produce research cell bank and conduct cell bank testing.

As a result of this modification, the total ceiling value is increased FROM $4,171,178.75 BY $441,638.00 TO $4,612,816.75 . The total funded amount is increased FROM $4,030,679.01 BY $122,288.00 TO $4,152,967.01 .

Statements of Work entitled “Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™ And Process Manufacturing Malaria Vaccine Production and Support Services, dated February 6, 2012 Subcontract Modification 12” are herein incorporated into and made part of Subcontract No. P010022290 and is attachment 1 to this modification 12.

Article 1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $4,612,816.75 including profit. This subcontract is incrementally funded for work to be performed through March 21, 2014. The total FUNDING of Subcontract No.P010022290 is $4,152,967.01 including profit.

Article 1.3 INVOICES is modified to read as follows:

Invoices shall contain the following information: subcontract number, subproject number, Stage #. Invoices may be mailed or emailed to:

Science Applications International Corporation

Attention: Carol Frishman

5202 Presidents Court, Suite 110

Frederick, Maryland 21703

carol.c.frishman@saic.com

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 3


LOGO

 

Article 2.0 TECHNICAL AND CONTRACTUAL POINTS OF CONTACT is modified to replace Michael Younkins with the following:

SAIC (BUYER):

Contractual: Carol Frishman

Article 1.4 PAYMENT — is modified to add the following:

 

(a) Original Subcontract Award: For each Stage of work there will be two invoices each totaling 50 % of the price for each Stage of Work, an initial invoice upon commencement of the Stage and a final invoice upon acceptance of the final report for each Stage.

The following table shall be utilized for Milestone Invoice submission for Modification 12 :

 

Milestone

  

Payment

  

Amount

  

Duration

Milestone 1: Strain Screening   

50% upon

commencement

   [*]   

Approximately 8

weeks from receipt

of synthetic genes

 

Milestone 1: Strain Screening

  

 

50% upon

delivery of report

  

 

[*]

  
Milestone 2 [OPTIONAL]: Fermentation Assessment of [*] in Pfēnex Expression Technology™   

50% upon

commencement

   [*]   

Approximately 6

weeks from receipt

of written

authorization to

proceed

 

Milestone 2 [OPTIONAL]: Fermentation Assessment of [*] in Pfēnex Expression Technology™

  

 

50% upon

delivery of report

  

 

[*]

  
Milestone 2A [OPTIONAL]: Provide [*] pure PfRh5 protein from [*] selected [*] clones respectively to SAIC   

 

50% upon

commencement

   [*]   

Approximately 7

weeks from receipt

of written

authorization to

proceed*

 

Milestone 2A [OPTIONAL]: Provide [*] pure [*] protein from [*] selected [*] clones respectively to SAIC

  

 

50% upon

delivery of report

  

 

[*]

  
Milestone 3 [OPTIONAL]: Preparation and Characterization of a P. fluorescens- [*] Research Cell Bank (RCB)   

50% upon

commencement

   [*]   

Approximately 4

weeks from receipt

of written

authorization to

proceed

 

Milestone 3 [OPTIONAL]: Preparation and Characterization of a P. fluorescens- [*] Research Cell Bank (RCB)

  

 

50% upon

delivery of report

  

 

[*]

  

 

* Duration for Milestone 2A will depend on expression and quality data of [*] from Milestone 2

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 3


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(b) Payment terms will be Net 45 days from date of invoice. Upon receipt of invoice Buyer shall within five (5) business days review the invoice and determine if the invoice is acceptable. If Buyer reasonable deems the invoice unacceptable Buyer shall contact Seller and Seller shall reissue a conforming invoice with a new date of invoice. If (1) Buyer does not pay on time or (2) Buyer’s financial responsibility becomes unsatisfactory (S&P rating below BBB- or Moody’s rating below Baa3) to Seller and Seller deems itself insecure, Seller may accelerate the due date and demand immediate payment on any outstanding invoice for Product, or may require cash payments or satisfactory security for future deliveries and for payment of all sums owed under this Agreement. Buyer agrees to pay all costs and expenses, including reasonable attorney’s fees, incurred by Seller in the collection of any sum payable by Buyer to Seller, or in the exercise of any remedy. Pfenex may charge Prime +2% on all overdue amounts.

Article 17.0 ORDER OF PRECEDENCE — is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment I: Statement of Work and Schedule dated February 6, 2012.

 

  2. Statements of Work and Schedules as follows:

Modifications - 6 dated 6/1/11, 5 dated 1/1/11, 4 dated 11/15/10, 2 dated 5/4/10 and original dated 5/11/11 respectively.

 

  3. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  4. Schedule B: U.S. Government Terms and Conditions, Part Ill — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  5. Attachment C (Enclosure 2; (Rev. 412009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION
/s/ Patrick Lucy     /s/ Carol Frishman

 

   

 

(Signature)     (Signature)
Name:   Patrick Lucy     Name:   Carol Frishman
 

 

     

 

(Type or Print)     (Type or Print)
Title:   Vice President of Business Development     Title:   Subcontracts Manager
 

 

     

 

Date:   2/24/12     Date:   2/24/12
 

 

     

 

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 3 of 3


Statement of Work

Evaluation of [*] Expression in P f ēnex Expression Technology™

and Process Manufacturing

Malaria Vaccine Production and Support Services

May 20, 2013

Subcontract Modification

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, and facilities for the full development of a manufacturing process for the [*] expressed from [*] clone using P f ēnex Expression Technology™ and technical transfer of the process to a SAIC designated cGMP manufacturing facility with processing capabilities and equipment compatible with the upstream and downstream process developed by Pfenex. The process shall be suitable for a scale up, at a minimum, of a [*] fermentation scale and follow-on purification, upon transfer. As part of this project, Pfenex is required to provide related meeting support, reports, and deliverables as listed in Table 1 .

 

  1.1. SAIC will provide the following information and materials:

 

    Background literature/references relating to [*].

 

    Additional [*] monoclonal antibodies (mAbs) and control Rh5, if required.

 

    Shipping instructions for purified [*] protein and other materials.

 

2. Technical Requirements

As a follow-on to the successful production, testing and selection of a [*] expressing cell line under the original subcontract and Mod 12 which was composed of: (i)-Evaluation of [*] (Stage 1), (ii)-Fermentation assessment of [*] (Stage 2A/Mod 12) and (iv)-Preparation and characterization of Pseudomonas -[*] (Stage 3); SAIC now requires Pfenex to develop a manufacturing process suitable for a scale up, at a minimum, of a [*] fermentation scale and follow-on purification for the SAIC selected clone [*] and technical transfer of the process to a SAIC designated cGMP manufacturing facility with processing capabilities and equipment compatible with the upstream and downstream process developed by Pfenex.

 

  2.1. Stage 4: Fermentation Optimization of cell line [*]

 

  2.1.1. Pfenex shall apply computer-aided, statistically-based design of experiments (DoE) to examine fermentation parameters [*] expression. Design and execute 2-level fractional factorial experiments to screen up to five (5) factors (e.g. pH and temperature) [*] expression in an 8-unit multiplex 1L bioreactor system.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 1 of 10


Please Note : Appropriate samples for yield determination and analysis will be collected throughout the fermentation runs.

 

  2.1.2. Perform the appropriate analysis on selected pre- and post-induction samples taken from the fermentations.

 

  2.1.3. Use JMP statistics software to analyze the data. Based on the conclusions, design a confirmation round of experiments up to a total of [*] X 1L fermentations.

 

  2.1.4. Evaluate [*] titer and quality on selected samples utilizing ELISA and western blot analysis development from Stage 7 Product Specific Analytical Method Development .

 

  2.1.5. The optimized fermentation condition shall be confirmed in up to [*] scale per round.

 

  2.1.6. The optimized fermentation shall produce material which can be subsequently purified to meet product quality safety specifications required for human use when produced under cGMP conditions.

 

  2.1.7. A technical study report shall be issued following the completion of the work.

 

  2.1.7.1. Pfenex shall submit the optimized fermentation procedure/protocol to SAIC for review and approval.

 

  2.1.7.2. Document shall also contain, at a minimum, in process parameters examined, rational for parameters selected, and copies of the raw data.

 

  2.2. Stage 5: Purification Process Development

 

  2.2.1. Pfenex shall develop a cGMP ready downstream purification process.

 

  2.2.2. Pfenex shall perform up to six rounds of [*] fermentation runs to supply cell paste for the experiments outlined in this stage of work.

 

  2.2.3. Pfenex shall develop a downstream purification process based on lessons learned from Stage 2A ([*] purification strategy).

 

  2.2.4. Pfenex shall design and execute a fractional factorial design to optimize protein release and purity [*].

 

  2.2.5. Pfenex shall evaluate efficiency (throughput, purity, recovery) of bulk separation of soluble and insoluble material by [*].

 

  2.2.6. Pfenex shall develop [*] will permit the material [*] to be filtered through a [*].

 

  2.2.7. Pfenex shall analyze samples taken throughout the primary recovery development for [*] yield and purity.

 

  2.2.8. Pfenex shall utilize the process intermediate from 2.2.7 to design and execute a resin screen (microtiter plate scale) for the primary capture chromatography step. Up to [*] will be screened for the best conditions for capacity. The best two resins will be screened in a second round using up to [*] conditions to determine selectivity.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 10


  2.2.9. Pfenex shall compare screening leads from 2.2.8 using test gradients and method scouting at small scale and rank performance with an emphasis on determining operating parameters (e.g., capacity, resolution, and yield) for protein with that resin

 

  2.2.10. The primary column resin and associated conditions selected from 2.2.9 will be optimized further for chromatography scale up and implemented at pilot scale.

 

  2.2.11. Pfenex shall utilize the elution pool from 2.2.10 to develop and execute a resin screen for the second chromatography step. Up to [*] will be screened for the best capacity and selectivity. The best resin will be screened in a second round using up to [*].

 

  2.2.12. Pfenex shall compare screening leads from 2.2.11 using test gradients and method scouting at small scale and rank performance with an emphasis on determining operating parameters (e.g., capacity, resolution, and yield) for protein with that resin.

 

  2.2.13. The second column resin and associated conditions selected from 2.2.12 will be optimized further for chromatography scale up and implemented at pilot scale.

 

  2.2.14. Pfenex shall utilize the elution pool from 2.2.13 to design and execute a resin screen for the polishing chromatography step. Up to eight resins will be screened for the best capacity and selectivity. The best resin will be screened in a second round using up to 36 conditions for efficiency and selectivity.

 

  2.2.15. Pfenex shall compare screening leads from 2.2.14 using test gradients and method scouting at small scale and rank performance with an emphasis on determining operating parameters (e.g., capacity, resolution, and yield) for protein with that resin.

 

  2.2.16. The polishing column resin and associated conditions selected from 2.2.12 will be optimized further for chromatography scale up and implemented at pilot scale.

 

  2.2.17. [*] from 2.2.16 will be buffer exchanged into the final drug substance buffer determined in Stage 6 using [*]. [*] parameters will be optimized to minimize processing time while maintaining product quality.

 

  2.2.18. For each downstream unit operation, Pfenex shall conduct hold studies to determine process intermediate stability.

 

  2.2.19. Pfenex shall perform analysis during development that may include [*].

 

  2.2.20. Pfenex shall perform a pilot scale integrated purification run to confirm scale-up parameters and overall process performance.

 

  2.2.20.1. Pfenex shall collect and analyze intermediate samples taken during the integrated run for protein yield, purity and contaminant profile.

 

  2.2.20.2. Pfenex shall provide [*] produced from the integrated run to SAIC or its designee.

 

  2.2.20.3. Pfenex shall perform analysis of integrated run final material that may include [*].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 3 of 10


  2.2.21. Pfenex shall submit the developed purification process procedures and protocols to SAIC for review and approval before moving forward to engineering run ( Stage 8 ).

 

  2.2.21.1. Document shall also contain, at a minimum, processes examined, rational or processes selected, and copies of the raw data.

 

  2.2.22. Pfenex shall ship [*] generated during development to a SAIC designated facility; however, Pfenex may retain all or a portion of the material produced for subsequent studies.

 

  2.3. Stage 6: BDS Formulation Development

 

  2.3.1. With material generated from Stage 5 Purification Process Development, Pfenex shall screen and evaluate at a minimum [*] buffer systems that are compatible with [*].

 

  2.3.1.1. Components/pH in the buffer systems should be suitable for human use and may include stabilizing excipients.

 

  2.3.1.2. Pfenex will measure compatibility of the buffer systems using SEC-HPLC and/or other stability indicating assays.

 

  2.3.2. Pfenex shall confirm the selected buffer systems to monitor quality changes of [*].

 

  2.3.3. Pfenex shall perform a short-term stability monitoring of selected, suitable buffer systems(s) to monitor quality changes of [*] and/or other stability indicating assays.

 

  2.3.3.1. Short term stability monitoring shall include the following temperature and time points:

 

Stress

  

Conditions

  

Time Point(s)

Temperature    [*]    [*]

 

  2.3.3.2. [*].

 

  2.3.4. Upon SAIC’s request, Pfenex shall provide [*] in the selected buffer system and concentration to SAIC for further testing

 

  2.3.5. Pfenex shall issue a final report. The report shall include an executive summary, detailed description of methods including system suitability controls, list of all raw materials and their source, results, conclusions, inventory of reagents provided by SAIC, and all raw data in PDF format.

 

  2.4. Stage 7: Product Specific Analytical Method Development

 

  2.4.1. Pfenex shall develop product specific in-process and final product analytical methods and provide standard operating procedures (SOPs) for each method.

Please Note: Method qualification may be performed as optional.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 4 of 10


  2.4.2. Pfenex shall establish acceptance criteria and specifications in consultation with SAIC, where applicable, that will be the basis for release and stability monitoring. The specifications shall be appropriate for a Phase 1 clinical product.

 

  2.4.3. For in-process testing of low purity fermentation and purification samples, the testing shall include: [*] analysis.

 

  2.4.4. For release testing of bulk drug substance, the testing shall include: [*]

 

  2.4.5. For characterization of bulk drug substance, the testing shall include: [*]

 

  2.4.6. Pfenex shall recommend and submit the developed analytical and characterization testing, including procedures, protocols, and their results, to SAIC for review and approval.

 

  2.4.7. (Optional) Analytical method qualification shall be performed on methods developed.

 

  2.4.7.1. Qualification protocols and report template shall be issued for review and approval

 

  2.4.7.2. Qualification report shall be issued and include data and summary tables.

 

  2.5. Stage 8: Engineering Run

 

  2.5.1. Pfenex shall perform a complete engineering run at the [*] scale to ensure reproducibility of previously drafted procedures.

 

  2.5.2. Pfenex shall develop master batch production records (BPRs) for the engineering run that covers all of upstream and downstream process, and identifies where the in-process tests occur and what volume is removed for testing. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

  2.5.3. Pfenex shall submit the completed BPRs to SAIC upon the completion of the engineering run.

 

  2.5.4. Pfenex shall execute the release and characterization testing as accomplished in Stage 7 for the engineering run material.

 

  2.5.5. Pfenex shall set aside aliquots for the stability program described below, and ship the remaining [*] from the engineering run to a SAIC designated facility in aliquots to be determined at a later timepoint.

 

  2.5.6. (Optional) Pfenex may perform additional engineering run(s) if required by SAIC

 

  2.5.6.1. Pfenex shall develop master batch production records (BPRs) for the engineering run that covers all of upstream and downstream process, and identifies where the in-process tests occur and what volume is removed for testing. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

  2.6. Stage 9: Stability Program

 

  2.6.1. Pfenex shall conduct a non-GMP stability monitoring of the [*]. Pfenex shall submit the stability monitoring plans for the engineering run to SAIC for review and approval.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 5 of 10


  2.6.2. The stability of purified [*] from the engineering run will be evaluated for stability at conditions [*].

 

Method/Test

–70°C, 5°C, 25°C/60% relative humidity (RH), 40°C/75% RH

   Initial
Testing

(T=0)
   1 mo    2 mo    3 mo
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X   
[*]    X    X    X   
[*]    X          X

 

  2.6.3. Stability monitoring assessment shall include: [*]

 

  2.6.4. A stability report shall be submitted to SAIC at each stability timepoint and include, at minimum, assays utilized with associated SOP, test results in table format, conclusion, trending data, and copies of raw data.

 

  2.7. Stage 10: Process Training and Transfer

 

  2.7.1. Pfenex shall train SAIC’s cGMP contract manufacture organization (CMO) on the manufacturing process and shall transfer the BPRs (master and completed) and analytical method SOPs.

 

  2.7.2. As part of the process training and transfer Pfenex shall conduct at least one successful training run.

 

  2.7.3. The process yield from the process training run shall be within acceptable scientific variation from the engineering run performed in Stage 8 .

 

  2.7.4. The process training run shall demonstrate within acceptable scientific variation reproducibility as compared to Stage 8, in all up- and down-stream processes including growth rate in fermentation, quantity and quality of Rh5 in lysate, in primary recovery, in each process step, and in final product.

 

  2.7.5. Pfenex shall provide to SAIC and to SAIC designated CMO the RCB and a full process transfer package with all information necessary for the transfer of the manufacturing process.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 6 of 10


  2.7.6. The full process transfer package shall include the following items:

 

  2.7.6.1. Bill of materials and suggested suppliers

 

  2.7.6.2. Detailed fermentation and purification process procedures (master BPRs)

 

  2.7.6.3. Listing of instruments/equipment

 

  2.7.6.4. Detailed testing procedures (SOPs)

 

  2.7.6.5. Technical specification for the bulk drug substance

 

  2.7.6.6. Health/Safety/Environment assessment of all materials and process

 

  2.7.6.7. Detailed characterization of purified protein/buffer and intermediates

 

  2.7.6.8. Stability testing plan and final report

 

  2.7.6.8.1. Research cell bank growth parameters and technical information

 

  2.7.6.8.2. Construct expression information and test results

 

  2.7.7. The process transfer and associated training records for the transfer to the clinical CMO shall be well documented and be provided to SAIC in the final report.

 

  2.8. CMC Support

 

  2.8.1. Pfenex shall provide support in reviewing CMC sections and documents related to IND submission including details of the cloning and development of the expression strain [*].

 

3. Quality Requirements

In addition to the Quality Requirements stated in the SOW, Pfenex shall execute a Quality Management Plan suitable for process development and technical transfer (see Section 10).

 

  3.1. Pfenex shall provide a scientific, technical, and administrative infrastructure to ensure quality control of all process development and technical transfer activities.

 

  3.2. The quality management plan shall include use of any materials, instruments/equipment, methods, procedures utilized in the process development and technical transfer.

 

  3.3. At a minimum, Pfenex shall ensure:

 

  3.3.1. Facilities in which SAIC’s materials are maintained in a safe and secure manner and allow limited access.

 

  3.3.2. Personnel have the necessary education and training in all procedures relevant to work assignments; training and qualifications are verified by leadership of Pfenex.

 

  3.3.3. SOPs will be used to document policies and procedures. SOPs will be version controlled and approved by key personnel.

 

  3.3.4. An effective tracking/tracing system or procedure is in place for all materials and equipment used in this contract.

 

  3.3.5. Equipment calibration and maintenance are performed as required and are documented.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 7 of 10


  3.4. The Quality Management Plan shall govern Pfenex’s commitment to quality and ensure that procedures addressing the following requirements are in place.

 

  3.4.1. SOPs

 

  3.4.2. Document/version control

 

  3.4.3. Equipment maintenance and repair

 

  3.4.4. Training: adherence of staff to required schedules

 

  3.4.5. Data management

 

  3.4.6. Record management system

 

  3.4.7. Safety plan

 

  3.4.8. Asset tracking and management

 

  3.4.9. Building and facility monitoring

 

  3.4.10. Adherence to Federal or other applicable regulatory requirements appropriate for work on this contract

 

  3.4.11. Operational deviations and failures will be investigated through root cause analysis, which will be documented.

 

  3.5. Cold/frozen and controlled temperature storage chambers have continuous monitors with alarms or are monitored at least every 4 hours by security staff. Any deviations will be immediately reported to Pfenex staff.

 

  3.6. Effective cold chain management practices are in place for the handling of materials, products and samples.

 

  3.7. Investigation are initiated upon incident discovery (excursion from written procedure, policy, or protocol). Upon request, copies results of investigations are submitted to SAIC for review.

 

  3.8. SAIC may schedule in-plant and other visits at Pfenex to audit quality of activities conducted in this contract.

 

4. Record Management Requirements

Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan).

 

  4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity.

 

  4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results.

 

  4.3. Record and document security systems shall be adequate to ensure confidentiality and proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC.

 

  4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 8 of 10


  4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site.

 

  4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer.

 

  4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request.

 

5. Table 1. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Technical    [*] from process development    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
2    Technical    [*] from engineering run    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
3    Technical    Unused reagents provided by SAIC    Within 2 weeks of SAIC request    Sent to SAIC designee in proper shipping containers
4    Technical    Optimized fermentation procedure and protocols    Within 3 week of completion    PDF or Word document
5    Technical    Selected primary recovery method    Within 3 week of completion    PDF or Word document
6    Technical    Purification process procedures and protocols    Within 3 week of completion    PDF or Word document
7    Technical    Recommended analytical and characterization testing    Within 3 week of completion    PDF or Word document
8    Technical    Master BPRs for the engineering run    2 weeks prior to initiation    PDF or Word document

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 9 of 10


Deliverable

  

Requirement

  

Item

  

Date*

  

Form

9    Technical    Master BPRs for the second engineering run, etc    2 weeks prior to initiation    PDF or Word document
10    Technical    Completed BPRs for the engineering run    Within 3 week of completion    PDF or Word document
11    Technical    Completed BPRs for the second engineering run, etc    Within 3 week of completion    PDF or Word document
12    Technical    Stability monitoring plans for engineering run(s)    2 weeks prior to initiation    PDF or Word document
13    Technical    stability reports    3 week following each indicated time point    PDF or Word document
14    Technical    Full Process transfer package    4 weeks following completion of engineering run    PDF or Word document
15    Reporting    Biweekly Meeting and minutes    Meeting as scheduled, minutes within a week of the meeting    Telecom
16    Reporting    Monthly Reports    Due by the 8 th of each month during the performance of work efforts    PDF or Word document
17    Reporting    CMC Support    Final: 3 weeks after receipt of SAIC CMC sections provided for review    Draft: Word document

 

* Days = calendar days

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 10 of 10


7A PRICE SHEET for Subcontract P010022290

May 24, 2012

Pricing is based upon commercial rates and is inclusive of costs for supplies, materials (except as noted) and reports.

 

Stage 7A Activity

   Payment Terms
(50% upfront/50%

issuance of final
report)
     Estimated
Labor
(hours)
   Estimated
Materials
Costs
   Estimated
Timescales

2.1.1 [*]

   $ [*]       [*]    [*]    3 weeks

2.1.2 [*]

   $ [*]       [*]    [*]    2 weeks

2.1.3 [*]

   $ [*]       [*]    [*]    5 weeks

2.1.4 [*]

   $ [*]       [*]    n/a    1 week

2.1.5-2.1.8 [*]

   $ [*]       [*]    n/a    3 weeks

2.1.9 [*]

   $ [*]       [*]    n/a    2 weeks

 

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Attachment 2 P010022290 Mod 13    Page 1 of 1


LOGO

SUBCONTRACT AGREEMENT P010022290 Modification 13

 

SUBCONTRACTOR:

 

Pfenex Inc.

10790 Roselle Street, San Diego,

CA 92121

   SUBCONTRACT #:    P010022290
  

 

MODIFICATION #:

  

 

13

  

 

DPAS RATING:

  

 

Not Rated

  

 

TYPE:

  

 

FIRM FIXED PRICE

  

 

COMMERCIAL ITEMS (GOVERNMENT)

 

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

 

  •    Modification Value:

  

 

$238,336.00

  

 

FUNDED:

  

 

$4,391,303.01

  

 

Ceiling VALUE:

  

 

$4,851,152.75

The purpose of this modification is to increase the ceiling value and funding value by $238,336.00 for additional work as stated below.

Effective date of this modification is June 15, 2012.

As a result of this modification, the total ceiling value is increased FROM $4,612,816.75 BY $238,336.00 TO $4,851,152.75 . The total funded amount is increased FROM $4,152,967.01 BY $238,336.00 TO $4,391,303.01 .

Statement of Work entitled “Evaluation of Malaria CSP Expression in Pf enex Expression Technology TM And Process Manufacturing Malaria Vaccine Production and Support Services, dated May 24, 2012 Subcontract Modification 13” is herein incorporated into and made part of Subcontract No. P010022290 as additional work and is attachment 1 to this modification 13.

1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $4,851,152.75 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No.P010022290 is $4,391,303.01 including profit.

Each Stage 7A Activity will commence upon request of SAIC representative in writing only. Payments will be made in accordance with Article 1.4 of this subcontract.

17.0 ORDER OF PRECEDENCE — is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment 1: Statement of Work and Schedule dated May 24, 2012, Mod 13.

 

  2. Attachment 2: 7A Price Sheet

 

  3. Statements of Work and Schedules as follows:

Modifications -12 dated 2/6/12, 6 dated 6/1/11, 5 dated 1/1/11, 4 dated 11/15/10, 2 dated 5/4/10 and original dated 5/11/11 respectively.

 

  3. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  4. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  5. Attachment C: (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on data shown.

 

PFENEX INC     SCIENCE APPLICATION INTERNATIONAL CORPORATION
/S/ Patrick Lucy     /s/ Carol Frishman

 

   

 

(Signature)     (Signature)
Name:   Patrick Lucy   Date 6/20/12     Name:   Carol Frishman   Date 6/20/12
 

 

     

 

(Type or Print)     (Type or Print)
Title:   Vice President of Business Development       Title:   Subcontracts Administrator  
 

 

     

 

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

 

STATEMENT OF WORK

Evaluation of Malaria CSP Expression in Pf enex Expression Technology TM

And Process Manufacturing

Malaria Vaccine Production and Support Services

May 24, 012

Subcontract Modification 13

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the production of additional filtered lysates, and purified [*] expressed in Pf enex Expression Technology TM . As part of this support, Pfenex shall be required to provide summary reports related to the development and manufacturing process, other documentation as required in the deliverables, bacterial cell lysates and reagent-[*] protein under specifications defined in Stage 7. Pfenex shall provide antigens, and reports and other documentation related to the development and manufacturing process, as required in the deliverables (Table 1). Milestones in this subcontract modification include:

Table 1. Milestones for CSP

 

Antigen

  

Milestones

  

Timeline

rCSP    Stage 7A : [*]    7-10 weeks, followed by Report in 2 weeks

SAIC will provide the following information and materials:

 

  1.1.1. Background literature/references relating to [*].

 

  1.1.2. Additional [*] and control [*], if required.

 

  1.1.3. Shipping instructions for filtered lysates and purified [*]

 

2. Technical Requirements

 

  2.1. Stage 7A: Provide improvements to [*] purification process for manufacture at large-scale (pilot) scale and provide rCSP purified material to SAIC’s Repository designate

 

  2.1.1. Pfenex shall investigate thawed lysate precipitation using centrifugation of thawed lysate to remove precipitation.

 

  2.1.2. Pfenex shall develop [*] to test for reduction of host cell protein levels to [*]. Note: SAIC shall decide on approval of Activity 2.1.3 pursuant to results from Activity 2.1.2.

 

  2.1.3. Pfenex shall incorporate a third chromatography step to reduce host cell protein levels to[*], pursuant to results from Activity 2.1.2.

 

  2.1.4. Pfenex shall perform buffer development to define acceptable deviation thresholds on key buffer formulations to better understand variability from preparation to preparation, and confirm buffers are robust, i.e. will meet process specifications from lot to lot.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

 

 

  2.1.5. Pfenex shall incorporate final buffer formulation from Stage 5A Preformulation Development of [*] Drug Substance and confirm at large-scale purification.

 

  2.1.6. Pfenex shall perform up to [*] scale fermentations to generate cell paste to support large-scale purification efforts. Targeted expression titer ranges shall be [*].

 

  2.1.6.1 Whole broth samples will be analyzed for titer by [*].

 

  2.1.7. Pfenex shall place in-process samples from the large-scale purification (Activity 2.1.5) on a short stability study to characterize hold times. The final [*] will be incorporated into Stage 8 Stability Program.

 

  2.1.8. Pfenex shall ship the remaining purified [*] to SAIC’s repository designate.

 

  2.1.9. Pfenex shall issue a final report of Stage 7A efforts.

 

  2.1.9.1 Pfenex shall refine master BPRs for the large-scale (pilot) development work that cover all downstream process and identified where procedures are modified, if any. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

3. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Project Management    Final Project Schedule    To be submitted within 1 week of kickoff meeting; schedule to be baselined within 3 weeks of award    1 electronic file, Preferably .mmp format
2    Meeting Requirement    Meeting Agenda    1 day prior to regular meetings, 3 days prior to kickoff    1 electronic Word document or email
3    Meeting Requirement    Meeting Summaries    7 days after meetings    1 electronic Word document
4    Technical Requirement    7A Milestone Report   

Draft: 2 weeks following completion of procedure

Final: 2 weeks after receipt of SAIC comments

  

Draft: Word Document

Final: Signed PDF

5    Technical Requirement    Antigen deliverables    2 weeks following completion of requirement    Sent to SAIC designee in proper shipping containers

 

* Days = Calendar days; SAIC shall provide comment within 1 week.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


LOGO

 

7A PRICE SHEET for Subcontract P010022290

May 24, 2012

Pricing is based upon commercial rates and is inclusive of costs for supplies, materials (except as noted) and reports.

 

Stage 7A Activity

   Payment Terms
(50% upfront/
50% issuance of
final report)
     Estimated Labor
(hours)
   Estimated
Materials Costs
     Estimated
Timescales

2.1.1 Precipitation Issues

   $ 34,560       120      n/a       3 weeks

2.1.2 HCP method development

   $ 14,824       48    $ 1,150 (ELISA kit)       2 weeks

2.1.3 HCP Reduction by Chromatography

   $ 86,400       300    $ 17,250 (resins)       5 weeks

2.1.4 Buffer Development

   $ 13,824       48      n/a       1 week

2.1.5-2.1.8 Large-scale (Pilot) demonstration

   $ 77,208       216      n/a       3 weeks

2.1.9 Final Report

   $ 11,520       40      n/a       2 weeks

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


LOGO

SUBCONTRACT AGREEMENT P010022290 Modification 14

 

SUBCONTRACTOR:   SUBCONTRACT #:   P010022290

 

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

 

 

MODIFICATION #:

 

 

14

 

 

DPAS RATING:

 

 

Not Rated

 

 

TYPE:

 

 

FIRM FIXED PRICE

 

 

COMMERCIAL ITEMS (GOVERNMENT)

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

 

 

•      Modification Value:

 

 

        $1,086,563.00

 

 

FUNDED:

 

 

$5,477,866.01

 

 

Ceiling VALUE:

 

 

$5,937,715.75

The purpose of this modification is to increase the ceiling value and funding value for additional work as stated below.

Effective date of this modification is July 31, 2012.

As a result of this modification, the total ceiling value is increased FROM $4,851,152.75 BY $1,086,563.00 TO $5,937,715.75 . The total funded amount is increased FROM $4,391,303.01 BY $1,086,563.00 TO $5,477,866.01 .

Statement of Work entitled “ Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™ And Process Manufacturing Malaria Vaccine Production and Support Services June 22, 2012 Subcontract Modification ” is herein incorporated into and made part of Subcontract No. P010022290 as additional work and is attachment 1 to this modification 14.

1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $5,937,715.75 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $5,477,866.01 including profit.

This Milestone Activity will commence upon request of SAIC representative in writing only. Payments for this modification 14 will be made in accordance with the schedule as outlined below.

 

Milestone

   Invoicing    Amount  

Milestone 1: Technology Transfer (including CMO Upfront Payments)

   Due upon execution of the
contract modification
   $ 864,209.00   

Project Management Storage & Shipping

   Due upon Initiation of GMP
manufacturing run
   $ 222,354.00   
     

 

 

 

Total for modification 14 Activity

      $ 1,086,563.00   
     

 

 

 

ADDITIONAL TERMS AND CONDITIONS:

 

  1. SAIC is responsible for all regulatory and quality issues related to Mod 14/cGMP Manufacturing.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 2


LOGO

 

 

  2. In the event SAIC shall be required to recall the Product because such SAIC Product may violate local, state or federal laws or regulations, or the laws or regulations of any applicable foreign government or agency, or does not conform to the Specifications, or in the event that SAIC elects to institute a voluntary recall, withdrawal, field alert or similar action (collectively a “Recall”), SAIC shall be responsible for coordinating such Recall. SAIC shall promptly notify Pfenex if the SAIC Product is the subject of a Recall and provide Pfenex with a copy of all documents relating to such Recall. Pfenex shall reasonably cooperate with Client in connection with any Recall and shall cause any of its Subcontractors to do the same, at SAIC’s expense. SAIC shall be responsible for all of the costs and expenses of such Recall except to the extent caused by a Limited Latent Defect in which case Pfenex shall cause the CMO to reimburse SAIC to that extent for its reasonable, direct and documented out of pocket expenses, up to an aggregate limit of $100,000 for all such Recall(s).

 

  3. If SAIC terminates Mod 14 then all unavoidable termination fees/costs incurred by Pfenex shall be reimbursed by SAIC.

 

17.0 ORDER OF PRECEDENCE — is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment I: Statement of Work and Schedule dated June 22, 2012, Mod 14.

 

  2. Statements of Work and Schedules as follows:

Modifications -13 dated 6/15/12, 12 dated 2/6/12, 6 dated 6/1/11, 5 dated 1/1/11, 4 dated 11/15/10, 2 dated 5/4/10 and original dated 5/11/11 respectively.

 

  3. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  4. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  5. Attachment C: (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Carol Frishman

(Signature)     (Signature)
Name:   Patrick Lucy   August 2, 2012     Name:   Carol Frishman   8/2/12
 

 

     

 

(Type or Print)   Date     (Type or Print)   Date
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

 

   

 

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 2


STATEMENT OF WORK

Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™

And Process Manufacturing

Malaria Vaccine Production and Support Services

June 22, 2012

Subcontract Modification

 

1. Background

The National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases (DMID), directed Science Applications International Corporation [Malaria Vaccine Production and Support Services Program, prime contract NO1-A1-05421] to develop early-phase malaria vaccines. SAIC provides project and quality management as well as regulatory support for DMID’s malaria vaccine development efforts. Under subcontract agreement (P010022290) with SAIC, Pfenex has developed a [*]. Currently, Pfenex has reached “Stage 9: Process Training and Transfer” which will facilitate the cGMP manufacture, release, and stability monitoring drug substance (DS) for use in Phase 1 clinical trials at a third party contract manufacture organization (CMO). As part of the Stage 9 agreement, Pfenex will coordinate with the CMO to perform the follow activities:

 

    Pfenex shall train the Pfenex-selected CMO manufacturing and QC staff, as necessary, using the information in the Pfenex technology transfer package.

 

    SAIC shall provide Pfenex selected CMO the working cell bank vials and WCB growth parameters and technical information

 

    Pfenex shall provide Pfenex selected CMO a full process transfer package with all information necessary for the successful transfer of the manufacturing process operable and reproducible at a minimum of [*] fermentation scale and shall include, but is not limited to, the following items:

 

    Bill of materials and suggested suppliers

 

    Detailed fermentation and purification process procedures (master BPRs)

 

    Listing of instruments/equipment

 

    Detailed testing procedures (SOPs)

 

    Technical specification for the bulk drug substance (BDS or DS)

 

    Health/Safety/Environment assessment of all materials and process

 

    Detailed characterization of purified protein/buffer and intermediates

 

    Construct expression information and test results

 

    The process transfer and associated training records of CMO personnel for the transfer to the CMO shall be well documented and be provided to SAIC in the final report.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


To further the successful transfer and manufacture of the [*] from Pfenex to the CMO, SAIC herein requests Pfenex to identify and subcontract a cGMP qualified CMO to perform the DS manufacture and release of [*], produced by production strain [*] for use in Phase 1 clinical trials.

 

2. Period of Performance

The period of performance (POP) for this effort is upon approval of the change of scope through September 2014.

 

3. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all necessary services, qualified personnel, and travel as needed to conduct the CMO subcontract technical management & coordination, cGMP manufacture and release of [*].

 

4. Technical Requirement

Pfenex Project Management and SAIC shall create a Project Coordination Team (PCT) that shall provide scientific, technical, and administrative oversight to ensure the efficient planning, initiation, implementation, and management of all activities carried out for the execution of Pfenex’s subcontract with the CMO. Details of the roles and responsibilities of the SAIC and Pfenex team members are described in detail in Section 5, Project Management ). Pfenex shall provide necessary ad hoc support to the CMO to ensure the success of all technical requirement activities. Upon SAIC’s request, Pfenex shall arrange for SAIC’s visit and audit at the CMO for monitoring tech transfer, engineering run(s) and GMP production activities, as well as other any other Quality Assurance functions (see Section 6, Quality for more details).

The technical requirement include the following milestones:

Milestone 1: Technical transfer

Milestone 2: Engineering runs (Optional)

Milestone 3: GMP manufacture (Optional)

Milestone 4: Testing and release of [*] at CMO (Optional)

Milestone 5: Regulatory support (Optional)

 

  4.1 Milestone 1: Technical transfer

 

  4.1.1 Beyond the agreed upon tech transfer activities to be undertaken under the existing Stage 9 agreement, Pfenex shall provide management and coordinating activities, between SAIC, Pfenex and the selected CMO, for the suitable scale [*] fermentation, process, and analytical methods transfer at the CMO.

 

  4.1.1.1 The PCT (Project Coordination Team) shall ensure that all updates, changes, decisions, findings, and study reports at the CMO site are directly transferred to Pfenex and SAIC within 48 hours of receipt or notification. SAIC shall be responsible for approval.

 

  4.1.2 The PCT shall provide all necessary documents for approval of transfer analytical methods, fermentation, and purification process of rCSP to the selected CMO at 5 L-scale.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


  4.1.3 The tech transfer runs shall generate sufficient interim non-GMP reference material to be used in the analysis of the engineering run(s).

 

  4.1.3.1 The interim reference standard (IRS) must pass the following tests: [*].

 

TESTS

  

SPECIFICATIONS

Appearance    [*]       [*]
Identification    A.    [*]    [*]
   B.    [*]    [*]
Protein content    [*]       [*]
Purity    A.    [*]    [*]
   B.    [*]    [*]
   C.    [*]    [*]

Structural

characterization (for information only)

   A.    [*]    [*]
   B.    [*]    [*]
Safety    A.    [*]    [*]
   B.    [*]    [*]
   C.    [*]    [*]
   D.    [*]    [*]
Potency    [*]       [*]

 

* Target specifications may be revised prior to the GMP run

 

  4.1.3.2 The IRS shall be aliquoted into up to [*]. (Note: assuming > [*] concentration)

 

  4.1.3.3 The IRS shall be placed on a 3-month stability program as outlined in the table below.

 

Method/Test

  

Initial

Testing

(T=0)

  

1 month

  

2 month

  

3 month

[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X         
[*]    X    X    X    X
[*]    X    X    X    X
[*]    X    X    X    X

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-3-


  4.1.4 The PCT shall provide SAIC QAD all reports documenting the success of the transfer of analytical methods, fermentation, and purification to Pfenex-selected CMO, including all materials, SOPs, and raw data generated in the transfer.

 

  4.1.4.1 PCT shall provide sufficient supporting evidence of the success of the transfer to SAIC QAD for approval.

 

  4.1.4.2 PCT shall receive the go/no go decision from SAIC QAD before moving forward to the engineering runs.

 

  4.2 Milestone 2: Engineering runs (Optional)

 

  4.2.1 PCT shall provide management and coordinating activities, between SAIC, Pfenex and the selected CMO, for all engineering run activities

 

  4.2.1.1 PCT shall ensure that all updates, changes, decisions, findings, and study reports at the CMO site are directly transferred to SAIC within 48 hours of receipt or notification

 

  4.2.2 The PCT shall provide all reports documenting the success of the engineering runs, including all materials, SOPs, and raw data generated in the transfer to Pfenex and SAIC QAD. SAIC QAD is responsible for approval.

 

  4.2.3 Up to two successful [*] runs shall be performed that will be of sufficient quality to be utilized in GLP toxicity studies.

 

  4.2.3.1 Unused cell paste from successful [*] fermentation runs shall be aliquoted into [*] batch sizes and stored in -80°C at Pfenex CMO, under agreed upon monitoring conditions.

 

  4.2.3.2 One successful [*]-scale purification run shall be performed with each [*] fermentation run. Note: current process flow diagram of [*]-scale purification run is provided for budgetary purposes (Exhibit 1).

 

  4.2.3.3 Potency data is not necessary BEFORE proceeding to second engineering run or GMP run. A decision will be submitted to SAIC QAD for approval based on the process and analytical data.

 

  4.2.4 The engineering run(s) shall generate interim sufficient quantity of non-GMP reference material to be used in future testing of GMP manufactured lots of [*].

 

  4.2.4.1 The reference standard must pass the assays designated as release and characterization tests as specified by the PCT for the GMP BDS lot.

 

  4.2.4.2 The reference standard shall be aliquoted in up to [*] and stored frozen at [*]. (Note: assuming concentration of [*])

 

  4.2.4.3 The reference standard shall be placed on a 12-month stability program with real-time storage, accelerated conditions, and freeze/thaw cycles as outlined in the table below.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-4-


  4.2.4.4 The stability tests to be performed at a minimum for all temperatures and conditions will be: [*].

 

Time Point

  

CSP Reference Standard Storage Temperature

  

£ -65°C

  

5°C±3°C

  

40°C±2°C/

70%±5% RH*

0 (lot release)    X      
1 Month    X    X    X
2 Month    X    X    X
3 Month    X    X    X
6 Month    X    X    X
9 Month    X      
12 Month    X      
1 Cycle Freeze/Thaw    X      
2 Cycle Freeze/Thaw    X      
3 Cycle Freeze/Thaw    X      

 

* RH, relative humidity

 

  4.2.5 PCT shall provide sufficient supporting evidence of the success of the engineering runs to SAIC QAD, i.e., completed BPRs and testing results, for approval

 

  4.2.6 PCT shall receive the go/no go decision from SAIC QAD before moving forward to the GMP manufacturing.

 

  4.3 Milestone 3: GMP manufacture of DS (Optional)

 

  4.3.1 If the second engineering run is successful and is performed with GMP-compliant documentation and quality, then that material shall be utilized as the deliverable for this milestone. CMO must address and resolve issues identified by SAIC QAD in quality audit report prior to commencement of GMP production of BDS.

 

  4.3.2 PCT shall provide management and coordinating activities, between SAIC, Pfenex and the selected CMO, for GMP run activities.

 

  4.3.2.1 Upon SAIC’s request, Pfenex shall facilitate/arrange for SAIC QAD and/or other SAIC representatives, at SAIC’s expense, to conduct audits at the Pfenex-selected CMO to ensure all cGMP activities and associated internal quality assurance (QA) and quality control (QC) review are compliant with U.S. Code of Federal Regulations Parts 210, 211, 600, and 610 and ICH Guidance on Quality of Biotechnological Products.

 

  4.3.2.2 PCT shall ensure that all updates, changes, decisions, findings, and study reports at the CMO site are directly transferred to SAIC QAD within 48 hours of receipt or notification.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-5-


  4.3.3 The master batch production records (MPRs) for the [*] cGMP run shall be provided to the PCT for review and approval.

 

  4.3.4 At a minimum, one successful [*] GMP fermentation run shall be performed using the rPfCSP WCB.

 

  4.3.4.1 Unused GMP cell paste will be aliquoted into 10 L batches in single-use closed bags, and will be stored at the Pfenex selected CMO facility in temperature monitored GMP storage locations (-80°C) under agreed upon monitoring conditions. Temperature monitoring records will be provided by Pfenex to SAIC upon request. SAIC will review shipping records to verify cold chain is maintained.

 

  4.3.5 Pfenex CMO shall perform successful [*]-scale purification(s) and provide 5 to 10 grams of purified GMP-grade CSP meeting the agreed upon specifications to SAIC or SAIC designated location.

 

  4.3.5.1 Interim bulk materials generated in each purification cycle must meet interim release specification to allow pooling to produce final bulk drug substance material.

 

  4.3.5.2 Interim release testing will include, but is not limited to the following, [*].

 

  4.3.6 Following PCT provided guidance, the drug substance (DS) shall be dispensed in aliquots suitable for long-term storage, release testing, and stability monitoring.

 

  4.3.6.1 SAIC aliquot sizes and container closures are:

 

    [*]

 

    Stability Samples: Vial component figuration to be determined (Note: [*])

 

  4.3.6.2 PCT to approve bottle specifications and labels in advance of the fills. (Stability monitoring of GMP Bulk DS will be determined at a later stage and scope of work will be handled as a contract modification.)

 

  4.3.7 CMO will ship Bulk drug substance samples to SAIC Designee using pre-approved, qualified shipping vendors, under the agreed upon shipping configuration

 

  4.3.8 The completed BPR shall be internally reviewed by the Pfenex CMO and then submitted to PCT and SAIC QAD for review.

 

  4.4 Milestone 4: Testing and release of [* ] DS at CMO (Optional)

 

  4.4.1 All analytical methods to be used at the CMO for release testing shall be qualified, based on mutual agreement within the PCT and SAIC QAD.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-6-


  4.4.2 The CoA, including a list of analytical methods and specifications as well as results shall be generated based upon an agreed upon testing plan.

 

  4.4.3 The cGMP [*] DS shall be shipped to an SAIC-designated facility.

 

  4.4.3.1 The CMO shall ensure the shipment will be at the required temperatures using a qualified shipping configuration for dry ice shipments with temperature monitoring. SAIC will be responsible for the review and approval of material following shipping.

 

  4.4.3.2 A material safety data sheet shall be prepared by Pfenex PCT and included in the shipment; duplicates of documents shall be provided to PCT and SAIC QAD.

 

  4.4.4 Any remaining development- and manufacture-related materials, such as cell bank, unpurified lysate, and in-process product, shall be shipped to SAIC’s repository upon SAIC’s request.

 

  4.4.5 PCT shall provide management and coordinating activities, between SAIC, Pfenex and the selected CMO, for release testing activities

 

  4.4.5.1 PCT shall ensure that all updates, changes, decisions, findings, and study reports at the CMO site are directly transferred to SAIC QAD within 48 hours of receipt or notification.

 

  4.5 Milestone 5: Regulatory support (Optional)

 

  4.5.1 The PCT shall transfer from the CMO to Pfenex and SAIC QAD all supporting material for the submission of an IND application by providing Chemistry, Manufacturing, and Control documentation (21CFR312.23) required by U.S. regulatory authorities. The supporting materials shall include, but are not limited to, the following:

 

  4.5.1.1 A detailed description of all production materials, including their derivation and the analytical methodology used to characterize and release these materials.

 

  4.5.1.2 A list of all raw materials, including source and methods to qualify their suitability for further manufacture. All animal-derived raw materials will be specifically identified, including details of country of origin.

 

  4.5.1.3 Analytical method development and /or qualification reports.

 

  4.5.1.4 A detailed description of the production process, including test sample points for intermediate materials and the DS.

 

  4.5.1.5 The DS labels including draft and final.

 

  4.5.1.6 Master and executed BPRs.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-7-


  4.5.1.7 Protocol (draft and final) for release testing of production materials and release of lots of DS, including descriptions of analytical methods and target specifications.

 

  4.5.1.8 CoAs for production materials and the DS; a detailed DS lot production report.

 

  4.5.1.9 Stability testing protocol (draft and final) for interim reference materials.

 

  4.5.1.10 Out-of-specification (draft and final) investigational reports.

 

  4.5.1.11 Control documentation for changes in analytical or manufacturing methods.

 

  4.5.1.12 Letter of cross-reference for Pfenex’s CMO Drug Master File.

 

5. Project Management

 

  5.1 Pfenex shall appoint a Project Manager who shall provide effective communications with SAIC’s PM and Subcontract Administrator in order to properly execute the manufacture of rPfCSP DS at the CMO. SAIC shall provide an equivalent PM who will coordinate the decisions with Pfenex that can affect scope, cost and schedule for work including testing, performed at the CMO.

 

  5.2 SAIC and Pfenex Project Management shall create a Project Coordination Team (PCT) that shall provide quality, scientific, technical, and administrative oversight to ensure the efficient planning, initiation, implementation, and management of all activities carried out for the execution of Pfenex’s subcontract with the CMO.

 

  5.2.1 The PCT is responsible for: (1) monitoring the CMO’s technical progress, including the surveillance and assessment of performance and recommending to the SAIC Subcontracts Administrator changes in requirements; (2) interpreting the SOW and any other technical performance requirements; (3) performing technical evaluation as required; (4) review invoices against technical work performed (5) performing technical inspections and acceptances required by this subcontract; and (6) assisting in the resolution of technical problems encountered during performance.

 

  5.3 SAIC and Pfenex PMs shall be responsible for:

 

  5.3.1 Facilitate and coordinate the activities the PCT Team members

 

  5.3.2 Project management and communications

 

  5.3.3 Tracking, monitoring, and reporting on status and progress

 

  5.3.4 Establishing and maintaining a risk register

 

  5.3.5 Provide tracking and verification of expenditures

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-8-


  5.3.6 Recommending modifications to project requirements and time lines, including projects undertaken by third-tier subcontractors

 

  5.3.7 Providing all deliverables according to the Reporting Requirements and Subcontract Deliverables sections of an agreed upon SOW to the CMO

 

  5.3.8 Scheduling and monitoring of all tests and/or work

 

  5.3.9 Collection and reporting of results

 

  5.4 Any changes in the SOW, POP, delivery schedule, costs incurred during the performance of this subcontract, or terms and conditions for the CMO shall be approved by the SAIC PM and Subcontracts Administrator prior to execution.

 

  5.5 The PCT, through Pfenex Project Management, shall direct the CMO to maintain an accurate inventory and package and transfer all remaining reagents purchased or provided through this subcontract to SAIC or a designated repository. The inventory shall be provided as part of a monthly report. The materials, if applicable, will be transferred in a manner sufficient to preserve their respective cold chains. SAIC will determine who is responsible for making this shipment and method used to maintain cold chain.

 

6. Quality

SAIC is contractually responsible for assuring that the CMO maintains a Quality System that ensures compliance with current Good Manufacturing Practices (cGMP) to ensure the product has the necessary safety, purity, identity and other quality attributes that are suitable for its intended use and that these efforts can be duplicated by an independent laboratory based solely on the documentation provided from CMO.

The PCT shall be responsible for the development and demonstration of suitability of contracted deliverables as well as providing reports and managing this project in a manner that meets scientific expectations of traceability and control.

The SAIC Quality Assurance Director (QAD) will verify that all CMO quality systems are in place and maintained prior to the execution of the sub-contracted GMP-related work effort and shall have access to all systems and documentation utilized for completion of this effort. All quality issues at the CMO shall be addressed prior to the execution of GMP-related work. Additionally, the SAIC QAD has the authority for review and final sign-off for acceptance of deliverables. The SAIC QAD has direct communication with the CMO’s QA/QC counterparts. As required, communications may be formal and include official responses to SAIC QAD audit reports, responses to deviations and associated investigation resolution documentation, or informal emails, teleconferences, and face-to-meetings.

SAIC shall perform an award audit of the Pfenex selected CMO to determine its adequacy, assessing the materials, systems, equipment, facilities and equipment to be utilized in the performance of product transfer, the engineering run and the cGMP manufacturing of the DS. Following the audit, SAIC shall provide a written report with stated findings and concerns to both CMO and Pfenex. SAIC shall verify remedial actions are completed by the CMO before GMP-contracted activities are initiated. The CMO shall complete follow-up to issues or concerns

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-9-


raised during quality audits as appropriate. SAIC is responsible for providing final approval of CAPA’s. SAIC QAD will provide on-going quality monitoring and oversight during the execution of sub-contracted activities. SAIC expects to have a person in the plant, as needed, to provide appropriate quality oversight.

 

7. Reporting Requirement

The PCT is responsible for monitoring quality, technical performance and budgetary updates and advising the (SAIC and Pfenex) subcontract administrator(s) on programmatic requirements. Further, they are responsible for coordinating these requirements with the USG Project and Contract Officers. Therefore, all communications and reports (technical and financial) from the CMO shall be sent directly to all PCT members (SAIC and Pfenex PMs) simultaneously in order allow unfettered access to all information that impacts technical and financial performance and decision making.

 

8. Subcontract Deliverables

Table 1 summarizes documents and other deliverables due to SAIC at the indicated time points.

 

Deliverable

 

Requirement

 

Item

 

Date

 

Form

1   Technical   Reports (technology transfer and engineering runs)  

Draft: 3 weeks following completion of transfer run

 

Final: 2 weeks after receipt of SAIC comments

  PDF or Word document
2   Technical   Remaining non-GMP [*] product (technology transfer and engineering runs) including cell paste interim reference material, and lysates   Within a week of completion   Sent to SAIC designee in proper shipping containers with a temperature monitor in each container
3   Technical   cGMP master BPRs  

Draft: 4 weeks before initiation

 

Final: 2 weeks after receipt of SAIC comments

  PDF or Word document
4   Technical   Completed rCSP cGMP BPRs  

Draft: 3 weeks following completion of 100 L cGMP run

 

Final: 2 weeks after receipt of SAIC comments

  PDF or Word document

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-10-


Deliverable

 

Requirement

 

Item

 

Date

 

Form

5   Technical   [*] along with associated raw data  

Draft: 3 weeks following completion of cGMP rPfCSP DS release testing

 

Final: 2 weeks after receipt of SAIC comments

  PDF or Word document
6   Technical   [*]   Within a week of completion   Sent to SAIC designee in proper shipping containers with a temperature monitor
7   Technical   Remaining cGMP unpurified cell paste and or lysate   Maintain GMP chain   Stored at Pfenex CMO in proper GMP storage conditions
8   Technical   Interim reports and a final stability report for the [*] stability monitoring  

Draft: 3 weeks following completion of each time point

 

Final: 2 weeks after receipt of SAIC comments

  PDF or Word document
9   Reporting   Biweekly meeting and minutes   Meeting as scheduled, minutes within a week of the meeting   Teleconference
10   Reporting   Monthly reports, including technical progress, and budgeting updates   Due by the 15th of each month during the performance of work efforts   PDF or Word document
11   Technical   Regulatory support documents  

Draft: 3 weeks following completion of all activities

 

Final: 2 weeks after receipt of SAIC comments

 

Draft: Word document

Final: Signed Pdf

12   Reporting   Inventory Tracking Report, including banked production materials, reagents, held intermediates and Drug Substance   Due by the 15th of each month during the performance of work efforts   PDF or Word document

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-11-


Exhibit 1 of SOW

Pfenex Inc. Confidential

 

# Step and Parameters

The process flow sheet is based on purifying 5 L fermentation and projected downstream process after development

 

In-Process Testing

    
   Fermentation (Pseudomonas fluorescens)      
  

Inoculum - batch

Seed broth volume

Fermentation time

  

 

0 6 L

~24 h

  
   Fermentation 2    i   
1   

Production - high density fed-batch

Production broth volume

Fermentation time

Expression Level

  

 

 

10 L

~48 h

4 g/L                     3-4 g/L

  
   Cell Paste by batch centrifugation      
2   

Production - high density fed-batch

Broth aliquot volume

Relative Centrifugation Force

Centrifugation Temperature

Centrifugation Time

  

 

 

1 L, cpy = 10

15900 × g

4°C

60 min

  
   Cell Reconstruction    i    Hold (-80°C)
3   

Feed

Paste Mass

Cycles Needed

Equipment

Mix Time

Dilution Buffer

Dilution buffer amount

Total volume upon dilution

Step Time

Step yield

  

Frozen (-80°C, Paste from step 3a

2.8 kg (equivalent to 5L broth)

2

Batch mixer

0.5 – 1 hr

20mM tris, 2M area

11.2 L approximate

14 L approximate

~1 hr

100%

  

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


In-Process Testing

    
4    Cell Lysis    i      2C g (per cycle)   
  

Feed

Equipment

Flush buffer

Flush buffer amount

Homogenization parameter

Lysate temperature

 

Number of passes

Lysis time

Step yield

  

14 L approximate from step 3

Niro Soayi

2M urea, 20mM Tris, pH 8.2

As needed

TBD (critical parameter)

Codec to < 12°C with heat exchanger at outlet)

1 pass

1.4 hr approximate (at ~ 0 L/hr)

100%

  

20% cell lysate: pH, Cond

Retain for SDS-PAGE/CGE

5    Dilution of 20% lysate to 10% solids 2C g (per cycle)
  

Feed

Feed volume

Equipment

Dilution buffer

Dilution buffer amount

Total volume upon dilution

Pump rate

Mix time

Step yield

  

Lysate from step 4

14 L

6C L single use bag Sartorius Stedim

2M urea, 20mM tris, PH 8

14 L approximate

28 L approximate

8 L/min

> 10 min

100%

  

10% cell lysate: pH, Cond

Retain for SDS-PAGE/CGE

6    Disk-Stack Centrifugation    i      2C g (per cycle)   
  

Feed

Feed volume

Feed Temp

Equipment

G-force

Flow rate

  

10% lysate from step 5

28 L

15 – 26 °C

Westfalia SC -6

15,000 g

0.3 L/mh

   Centrate turbidity (HACH NTU as well as Althea equipment measurement)
   Q/ S    8.10E-10 m/s   
  

Backpressure

Discharge Interval

Discharge Volume

Centrate Temp

 

Step Time

Step yield

  

75-82 psi

20 min

0.7 L

<20°C, cooled by heat exchanger on the outlet

1.6 hrs

88%

  
7    Depth Filtration    i      16 g (per cycle)   
  

Feed

Feed volume

Equipment

Manufacturer

Part #

  

Centrate from Step 6

24.64 L

Millistak+XOHC Depth Filter

Millipore

MXOHC05=S1

  

Depth Filter Equilibration:

pH, cond

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


In-Process Testing

    
  

Quantity

Filter Area

Filter Loading

Flowrate

Step time

Step yield

  

1

0.22 m2

112 L/m 2

33 – 50 LM-I 0.12 – 0.18 l/min

1 hr, run in parallel with centrugation

95%

  
8    Sterile Filtration    i      17 g (per cycle)   
  

Feed

Feed volume

Equipment

Manufacturer

Part #

Quantity

Filter Area

Filter Loading

Flowrate

Step Time

Step yield

  

Filtrate from Step 7, processed in-line

24.64 L

Sartobran P (0.45/0.2um)

Sartorius

5.235307H9-OO-V

1

0.20 m2

123 L/m2

36-54 LMH 0.12-0.18 L/min

N/A run in parallel with step 7

100%

  

Primary Recovery Filtrate: pH, cond

Retain for SDS-PAGE/CGE

9    Freezing of CSP clarified cell culture    i            17 g (per cycle)   
  

Feed

Feed Volume

Equipment

Manufacturer

Part #

Quantity

Step Time

Step Yield

  

Filtrate from Step 8

24.64 L

Sartorius Stedim Bags

Sartorious

Celsius FFT 2L, Celsius FFT 12L

4 of each part#

48-72hrs Specs TBD

100%

  
10    Thawing and filtration of CSP clarified cell culture    i            17 g (per cycle)   
  

Feed

Thaw volume

Equipment

Filter

Part #

Quantity

Filter Area

Filter Loading

Flowrate

Thaw Time

Filtration Time

Step time

Step yield

  

Filtrate from Step 8

24 L

Water Bath @ 25°C

TBD

TBD

1

TBD       m2

TBD       L/m2

TBD       LMH

< 4 hrs

TBD

< 5 hrs

97%

  

Thawed Filtrate: pH, cond

Retain for SDS-PAGE/CGE

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-3-


In-Process Testing

    
11    Primary Capture    i            16 g (per cycle)   
  

Feed

Feed Volume

Resin

 

Resin Amount

Equipment

Mode

Capacity

Flow rate

Bed height

Residence time

Loading Ratio

Equilibration/wash buffer

Washes

Elution buffer

Elution

Product elution volume

Strip

Clean, sanitize

Cycles Needed

Process time

Step yield

Step yield (vol)

  

Filtrate from step 10

24 L approximate

Fracotgel TMAE HiCap (M), an ion exchange resin

5.2 L approximate

20 cm column + 6 mm BioProcess skid

Bind and elute

~3 g/L resin estimated

150 cm/H          47.1 L/h

16.6 cm

7 min

4.6 L of Feed per L of Resin

20mM Tris, 2M Urea, pH 6.1

5 CV

20mM Tris, 2M Urea, 75 mM NaCL, pH 8.1

3.5 CV with higher NaCL

3 CV estimated

High salt g caustic

Common industry practice

1

5.4 hrs approximate

80% estimated

15.7 L approximate

  

TMAE Eluate pH, Cond, osmo (?, as a way to validate adj. pri HCT load)

Retain for SDS-PAGE/CGE

12    xxxxxxxxxxxxxxxx    i            16 g (per cycle)   
  

Xxxxxxxxxxxxxxxx

Xxxxxxxxxxxxxxxx

Xxxxxxxxxxxxxxxx

xxxxxxxxxxxxxxxx

  

 

xxxxxxxxxxxxxxxx

  

 

Elution Immediately Processed to Step 13

13    Ceramic HA Chromatography    i            13 g   
  

Feed

Feed Volume

Resin

Resin Amount

Equipment

Mode

Capacity

Flow rate

Bed height

Residence time

  

Filtrate from step 12

15.7 L approximate

Ceramic Hydroxyapetite

5.2 L approximate

20 cm column + 6 mm Bio Process skid

Bind and clute

3 c/L resin estimated

1511 cm/h        4/1 L/h

16.6 cm

7 min

  

CHT Load: pH, cond, osmo (as way to validate adjustments)

Retain for SDS-PAGE/CGE

 

 

 

Eluate: pH, cond, endotoxin

Retain for SDS-PAGE/CGE

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-4-


In-Process Testing

    
  

Loading Ratio

Equiliberation/Wash 1 buffer

 

Wash 1

Wash 2 Buffer

 

Wash 2

Elution

Product elution volume

Strip

Clean, Sanitize

Process time

Step yield

Step yield (vol)

  

3.00 L u/Feed per L of Resin

1mM phosphate, 50mM HEPES, 2 M urea, 75mM Nacl, pH 7.5

10 CV

4mM phosphate, 50 mM HEPES, 2M urea, 75mM NaCL, pH

5 CV

3.5 CV win 50 mM NaPO4

3 CV estimated

0.5M NaPO4

Common industry practice

5.6 hrs practice

90% estimated

16 L approximate

  
14    Sterile Filtration    i            11.6 g   
  

Feed

Filter

 

Filter capacity

Step Time

Step Yield

  

Filtrate from step 13

Sartobran 0/15/0.2-um sterilizing grace filter, 500 cm2

313 L/m2 loading

0.5 hrs

99%

  

 

5235307H7-OO0A

(Sartorius Stedim)

-500 cm2 filter

15    Mild Reduction of CSP    i            11.4 g   
  

Feed

Feed volume

Reductant

 

Reductant Concentration

Reductant Volume

Final Colume, HA Eluate +

Reductant Concentration

Equipment

Temperature

Reduction Time

Agitator

Agitator Rate

Filter

Par. #

Quantity

Filter Area

Filter Loading

Flowrate

Step time

Step Yield

  

HA Eluate from step 14

16 L

DIthiothreitol crystals U.T. Baker #JT-F780-2)

10 mM

0.0314 L          (-HA Eluate Volume/499

15.68 L

20 m m

50_ disposable sted m bag

15-25 LC

12-1X rrs

Recirculation on with Perstatic Pump

15-25% (v/vi per minute)

Sartobran P (0 45/0 2urm)

5235307H7—OO-V

 

0.05 m2

X1X 1/m2

1-2 L/min

12 – 10 hrs

99%

  

 

Pre-Reduction: A280, SEC, RR

Retain for SDS-PAGE/CGE

 

(Sartorius Stedim) -500 cm2 filter

 

Post-Reduction: a280, SEC,
RP, endotoxin

Retain for SDS-PAGE/CGE

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-5-


In-Process Testing

    
16    TFF (Concentration and Buffer Exchange)    i            11.9 g Many parameters yet to be optimized
  

Feed

Feed Volume

Membrane

Membrane Loading

Number of membranes

Equipment

 

Pumprate

 

Exchange into

Diafiltration

Diafiltration buffer

Clean and sanitize

Ultrafiltration time

Retentate volume

Step time

Step yield

  

Filtrate from step 1C

15.7 L approximate

16 m2, 6 k/a regenerated cellulose

11.3 g/m2

2

Peristatic pumas cassete holders pressure sensors

324 | MH (1 per m2 per min)

5.4 L/min/m2

TED

6 fold

144 L approximate

Industry practice

Hrs approximate

14 L approximate

5.0 hrs, including prep and clearing

90%

  

 

Equilibration: pH, (endotoxin?)

 

 

[                    ]

-Pellicon 2, C-screen UF cassette

 

Retentate: A280, retain for SDS-PAGE/CGE

17    Sterile filtration and bulk fill    i            10.2 g   
  

Feed

Filter

Filter Area

Filter Capacity

Step Time

Step yield

  

Retentate from step 16

Wilpak 2000 22um sterilizing grade

OV m2

14 L/m2 loading

30 min

99%

  

All BDS release testing as outlined in documentation

 

MPVL2GCA3 )EMD Millipore)

- Millipak 200, 0.2 um

1000 cm2

      Grams per 6L cycle 10.1 g   

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-6-


LOGO

SUBCONTRACT AGREEMENT P010022290 Modification 15

 

SUBCONTRACTOR:   SUBCONTRACT #:   P010022290

 

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

 

 

MODIFICATION #:

 

 

15

 

 

DPAS RATING:

 

 

Not Rated

 

 

TYPE:

 

 

FIRM FIXED PRICE

 

 

COMMERCIAL ITEMS (GOVERNMENT)

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

 

 

•      Modification Value:

 

 

        $311,000.00

 

 

FUNDED:

 

 

$5,788,866.01

 

 

Ceiling VALUE:

 

 

$6,248,715.75

The purpose of this modification is to increase the ceiling value and funding value for additional work as stated below.

Effective date of this modification is August 17, 2012.

As a result of this modification, the total ceiling value is increased FROM $5,937,715.75 BY $311,000.00 TO $8,248,715.75 . The total funded amount is increased FROM $5,477,866.01 BY $311,000.00 TO $5,788,866.01 .

Statement of Work entitled “ Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™ And Process Manufacturing Malaria Vaccine Production and Support Services May 4, 2012 Subcontract Modification ” is herein incorporated into and made part of Subcontract No. P010022290 as additional work and is attachment 1 to this modification 15.

1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $6,248,715.75 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $5,788,866.01 including profit.

This Milestone Activity will commence upon request of SAIC representative in writing only. Payments for this modification 15 will be made in accordance with the schedule as outlined below.

 

Milestone

  

Payment

  

Amount

   

Duration

[*] (Antigen 1) Milestone 2B

   50% upon
commencement
     [*   Approximately nine (9) weeks
   50% upon delivery of
report
     [*  

[*] (Antigen 2) Milestone 28

   50% upon
commencement
     [*   Approximately seven (7) weeks
   50% upon delivery of
report
     [*  

[*] (Antigen 2) Milestone 2C

   50% upon
commencement
     [*   Approximately two (2) weeks
   50% upon delivery of
report
     [*  

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 2


LOGO

 

17.0 ORDER OF PRECEDENCE — is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment I: Statement of Work and Schedule dated May 4 2012, Mod 15.

 

  2. Statements of Work and Schedules as follows:

Modifications -14 dated 6/22/2012, 13 dated 6/15/12, 12 dated 2/6/12, 6 dated 6/1/11, 5 dated 1/1/11, 4 dated 11/15/10, 2 dated 5/4/10 and original dated 5/11/11 respectively.

 

  3. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  4. Schedule B: U.S. Government Terms and Conditions, Part Ill — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  5. Attachment C: (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Carol Frishman

(Signature)     (Signature)
Name:  

Patrick Lucy                                         date 8/31/12

    Name:  

Carol Frishman                                     date 8/31/12

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 2


STATEMENT OF WORK

Evaluation of Malaria CSP Expression in Pf enex Expression Technology TM

And Process Manufacturing

Malaria Vaccine Production and Support Services

May 4, 2012

Subcontract Modification

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the proof-of-principle evaluation of expressing full-length and functional [*], suitable for use with [*] in combination vaccines, utilizing Pf enex Expression Technology TM . Pfenex shall provide antigens, and reports and other documentation related to the development and manufacturing process, as required in the deliverables (Table 1). Milestones in this subcontract modification include:

Table 1. Milestones for CELTOS/TRAP

 

Antigen

  

Milestones

[*]

(Antigen 1)

   Milestone 2B : [*] protein from 1 selected [*]
[*]

(Antigen 2)

  

Milestone 2B : Provide additional purification development to support Milestone 2A ([*] produced [*] expression strains to SAIC)

 

Milestone 2C (OPTION) : Endotoxin Reduction Development

 

1. SAIC will provide the following information and materials:

 

  1.1. Background literature/references relating to [*].

 

  1.2. Suitable reference materials and sera relating to [*] if available.

 

2. Technical Requirements

 

  2.1. Milestone 2B [*] to SAIC

 

  2.1.1. Pfenex shall screen different wash conditions on HIC column as well as TMAE HiCap, for separation of endotoxin from target varying factors such as pH, detergents, solvents, heat treatment, etc

 

  2.1.2. Pfenex shall confirm endotoxin reduction results observed in 2.1.1 and conduct small scale chromatography runs using conditions identified in 2.1.1.

 

  2.1.3. Pfenex shall perform additional fermentation runs in a 1L-scale high-cell density bioreactor as needed to support purification of CelTOS from [*].

 

  2.1.4. Pfenex shall purify up to [*] protein ([*] purity by SDS-CGE) from strain [*] with acceptable endotoxin levels ([*]).

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


  2.1.5. Pfenex shall analyze the final purified protein and the filtered lysate using analytical methods including [*].

 

  2.1.6. If the quality and purity of purified protein is deemed acceptable by SAIC for R&D non-clinical studies, Pfenex shall ship the resulting purified [*] protein ( ³ 10 mg) to SAIC.

Note: Pfenex will complete the activities as described and shall assume no risk in the ability to deliver the 10 mg of [*] protein. The completion of the activities described shall suffice in meeting the deliverable and will be deemed acceptable to issue an invoice for the final 50% of the price.

 

  2.1.7. Pfenex shall issue a final report of purification efforts.

 

  2.1.8. Report shall include an executive summary, brief description of methods, results and conclusions, inventory of reagents provided by SAIC, and raw data in PDF format.

 

  2.2. Milestone 2B ( [*] ): Provide additional purification development to support Milestone 2A ( [*] protein from 3 selected [*] clones respectively to SAIC)

Note : As part of Milestone 2A: Pfenex shall perform additional resin screening to identify chromatography media for primary capture and secondary capture of TRAP. Pfenex shall perform additional fermentation runs in 1L-scale high-cell density bioreactor to support purification of [*] protein

 

  2.2.1. Pfenex shall conduct small scale chromatography runs using conditions identified in Milestone 2A and purify up to 10 mg of purified [*] protein from strains [*] with acceptable endotoxin levels ([*]).

Note : Pfenex will complete the activities as described and shall assume no risk in the ability to deliver the [*] of [*] protein. The completion of the activities described shall suffice in meeting the deliverable and will be deemed acceptable to issue an invoice for the final 50% of the price described in this contract modification and the final 50% of the price described in Contract Modification 6 Antigen 2 Milestone 2A.

 

  2.3. Milestone 2C ( [*] ): Pfenex shall screen different wash conditions on selected chromatography media, for separation of endotoxin from target varying factors such as pH, detergents, solvents, heat treatment, etc

 

  2.3.1. Pfenex shall confirm endotoxin reduction results observed in 3.2.2 and conduct small scale chromatography runs using conditions identified in 3.2.2.

 

  2.3.2. Pfenex shall analyze the final purified proteins and the filtered lysate using analytical methods including [*]

 

  2.3.2.1  

 

  2.3.3. If the quality and purity of purified protein is deemed acceptable by SAIC for R&D non-clinical studies, Pfenex shall ship the resulting purified [*] protein (>10 mg) from 3 selected [*] clones to SAIC.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


Note : Pfenex will complete the activities as described and shall assume no risk in the ability to deliver the [*] of [*]. The completion of the activities described shall suffice in meeting the deliverable and will be deemed acceptable to issue an invoice for the final 50% of the price described in this contract modification and the final 50% of the price described in Contract Modification 6 Antigen 2 Milestone 2A.

 

  2.3.4. Pfenex shall issue a final report of purification efforts.

 

  2.3.5. Report shall include an executive summary, brief description of methods, results and conclusions, inventory of reagents provided by SAIC, and raw data in PDF format.

 

3. Quality Requirements

 

  3.1. Pfenex shall maintain a Quality System that meets scientific expectations of traceability, reliability and control. Pfenex shall be responsible for the development and demonstration of suitability of contracted deliverables as well as providing reports and managing this project in a manner that meets scientific expectations of traceability, reliability and control ensuring that the filtered whole cell lysate or periplasmic release extract and cell free broth produced and analyzed in the developed process and assays have the quality, and identity they purport.

 

4. Meeting and Conference Requirements

Unless an alternative directive is provided; meeting, conference, and audit support shall include the following:

 

  4.1. Pfenex shall schedule a kickoff meeting via teleconference with SAIC within 7 days of award. The agenda shall be provided by Pfenex in advance. The purpose of the kickoff meeting is formal introduction of key staff and project management, technical and contractual discussions, and initial action items required to initiate contract work.

 

  4.2. Pfenex shall participate in biweekly meetings and/or teleconferences with SAIC. Such meetings may include, but are not limited to, meetings to discuss the technical (e.g., assay designs and critical reagents), quality, schedule, regulatory, and contractual aspects of the program and site visits to Pfenex’s facilities. All visits to Pfenex’s facility shall be prearranged. Pfenex shall be responsible for preparing meeting agendas and summaries. Meeting minutes shall be captured by Pfenex and are due to SAIC within 7 days after the completion of a biweekly teleconference.

 

  4.3. Pfenex also shall be available for ad hoc support (e.g., phone calls and e-mails) to SAIC as required for project communications.

 

5. Reporting Requirements

 

  5.1. Monthly Technical and Business Progress Report: A monthly TPR shall be submitted to the SAIC management point of contact by the eighth of each month during subcontract POP.

 

  5.1.1. The TPR shall cover the work accomplished as well as issues and proposed resolutions that occur during each reporting period.

 

  5.1.2. Each TPR also shall contain an updated monthly project management schedule to indicate work completed and any change in schedule. Deliverables shall be incorporated into the schedule.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-3-


  5.2. Reports should include an updated inventory log, and a notice of any temperature deviations of equipment storing SAIC material. The report shall also document any changes made to methods and procedures utilized for the cloning and expression efforts.

 

  5.2.1. Report shall include invoicing information for work performed during each reporting period and anticipated work activities.

 

  5.3. Documentation to Support an IND or Amendment: Data generated under this subcontract may be incorporated into an FDA submission. Pfenex shall provide a list of relevant SOPs or other control, development and testing documents as requested.

 

6. Subcontract Deliverables

 

  Table 2 summarizes documents and other deliverables due to SAIC at the indicated timelines.

Table 2. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Project Management    Final Project Schedule    To be submitted within 1 week of kickoff meeting; schedule to be baselined within 3 weeks of award    1 electronic file, Preferably .mmp format
2    Meeting Requirement    Meeting Agenda    1 day prior to regular meetings, 3 days prior to kickoff    1 electronic Word document or email
3    Meeting Requirement    Meeting Summaries    7 days after meetings    1 electronic Word document
4    Technical Requirement    Milestone Reports [If Funded]    Draft: 2 weeks following completion of procedure Final: 2 weeks after receipt of SAIC comments    Draft: Word Document Final: Signed PDF
5    Technical Requirement    Antigen deliverables    2 weeks following completion of requirement.    Sent to SAIC designee in proper shipping containers

 

* Days = Calendar days; SAIC shall provide comment within 1 week.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-4-


LOGO

 

SUBCONTRACT AGREEMENT P010022290 Modification 16

 

SUBCONTRACTOR:   

SUBCONTRACT #:

 

   P010022290

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

  

MODIFICATION #:

 

   16
  

DPAS RATING:

 

   Not Rated
   TYPE:    FIRM FIXED PRICE
  

 

COMMERCIAL ITEMS (GOVERNMENT)

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

 

•    Modification Value:            $-217,854.00***

  

 

FUNDED:

  

 

$5,571,012.01

   Ceiling VALUE:    $6,253,215.75

The purpose of this modification is to correct the funding amount and add additional services in support of pre-clinical development.

Effective date of this modification is September 21, 2012.

As a result of this modification, the total ceiling value is increased FROM $6,248,715.75 BY $4,500.00 TO $6,253,215.75 . The total funded amount is decreased FROM $5,788,866.01 BY $217,854.00 TO $5,571,012.01 . The ceiling value remains $6,253,215.75 .

Statement of Work entitled “ Evaluation of Malaria CSP Expression in P f ēnex Expression Technology™ And Process Manufacturing Malaria Vaccine Production and Support Services September 14, 2012 Subcontract Modification 16 ” is herein incorporated into and made part of Subcontract No. P010022290 as additional work and is attachment 1 to this modification 16.

 

*** Funding is corrected as listed below:

Mod 14 funding corrected from $1,086,563.00 to $864,209.00 (less $222,354.00)

 

Mod 15

   $ 311,000.00   

Mod 16 for SOW 9/14/12

   + $ 4,500.00   
  

 

 

 
   $ 1,179,709.00   

Funding at Mod 13

   + $ 4,391.303.01   
  

 

 

 

Total amount funded all Mods

   $ 5,571,012.01   

1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $6,253,215.75 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $5,571,012.01 including profit.

This Activity will commence upon request of SAIC representative in writing only. Payments for this modification 16 will be made in accordance with the schedule as outlined below.

Payment of $4,500.00 due upon the initiation of testing of the vials.

Delivery of Modification 16 is approximately two weeks from commencement.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 2


LOGO

 

17.0 ORDER OF PRECEDENCE — is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment I: Statement of Work and Schedule dated September 14, 2012.

 

  2. Statements of Work and Schedules as follows:

Modifications — 16 dated September 14, 2012, 15 dated May 4 2012, 14 dated 6/22/2012, 13 dated 6/15/12, 12 dated 2/6/12, 6 dated 6/1/11, 5 dated 1/1/11, 4 dated 11/15/10, 2 dated 5/4/10 and original dated 5/11/11 respectively.

 

  3. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  4. Schedule B: U.S. Government Terms and Conditions, Part III — FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  5. Attachment C: (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite internal Controls.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Carol Frishman

(Signature)     (Signature)
Name:  

Patrick Lucy                                             date 9/28/12

    Name:  

Carol Frishman                                         date 9/28/12

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 2


LOGO

September 14, 2012

Carol C. Frishman

Subcontracts Administrator

Health Solutions Business Unit

Science Applications International Corporation

5202 Presidents Court, Suite 110

Frederick, MD 21703

Dear Ms. Frishman,

Please find enclosed Pfenex Inc.’s contract modification proposal for additional services in support of pre-clinical development of the circumsporozoite protein (CSP). The specific activities are described in the statement of work below. This scope of work will be Contract Modification 16 to Subcontract #P010022290 related to SAIC Prime Contract # N01-AI-05421. If all options are exercised the total Firm Fixed Price of this program in accordance with Statement of Work enclosed is $4,500 inclusive of materials.

This proposal is valid for 120 days from today’s date.

We look forward to continuing to work with you on this program.

 

Sincerely,
/s/ Patrick Lucy
Patrick Lucy
Vice President of Business Development
Pfenex Inc.
301 Newbury Street PMB #251
Danvers, MA 01923
Tel. (978) 887-4971
PKL@pfenex.com

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-1-


LOGO

STATEMENT OF WORK

Evaluation of Malaria CSP Expression in Pf enex Expression Technology™

and Process Manufacturing

Malaria Vaccine Production and Support Services

September 14, 2012

Subcontract Modification 16

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, facilities, and travel not otherwise provided under the terms of this agreement as needed for the preparation of vials containing diluent that will be used in support of pre-clinical studies.

 

2. Technical Requirements

 

  2.1. Pfenex will prepare vials containing meeting the following requirements:

 

  2.1.1 Number: [*]

 

  2.1.2 Formulation: [*]

 

  2.1.3 Fill Volume: [*]

 

  2.1.4 Vial Type: [*]

 

  2.1.5 Container Closure: Screw cap

 

  2.1.6 Label Description: Name (rCSP Dilution Buffer), Date, Manufacturer, Formulation, Expiration Date

 

  2.1.7 Storage conditions: Following the completion of the filling and labeling exercise the vials will be stored at -80° C prior to shipment. In transit the vials will be shipped on dry ice.

 

  2.1.8 SAIC will provide detailed shipping instructions when they would like the vials shipped to a designated location.

 

  2.1.9 Specification: A Certificate of Analysis shall be provided and will include the following test results: pH, conductivity, osmolality and endotoxin (LAL) test results.

 

3. Cost Proposal

The pricing for the proposal shall be based upon commercial rates and is inclusive of costs for supplies and materials. The pricing is broken down as follows:

Total Price - $[*]

Payment Terms – 100% due upon the initiation of testing of the vials.

Time-scale – Approximately two (2) weeks from commencement.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


LOGO

 

SUBCONTRACT AGREEMENT P010022290 Modification 17

 

SUBCONTRACTOR:   

SUBCONTRACT #:

 

   P010022290

 

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

  

MODIFICATION #:

 

   17
  

DPAS RATING:

 

   Not Rated
  

TYPE:

 

   FIRM FIXED PRICE
  

COMMERCIAL ITEMS (GOVERNMENT)

 

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

•    Modification Value:            $0

 

   FUNDED:    $5,571,012.01
   Ceiling VALUE:    $6,253,215.75

The purpose of this modification is to correct the Milestone Chart as shown on Modification 14 to read as shown below.

Effective date of this modification is October 9, 2012.

 

Milestone

  

Invoicing

   Amount  

Milestone 1: CMO Initiation

  

Due upon execution of the contract modification,

   $ 293.831.06   

Milestone 1a: Technology Transfer

  

Due upon execution of Tech Transfer

   $ 570,377.94   

Project Management Storage & Shipping

  

Due upon Initiation of GMP manufacturing run

   $ 222,354.00   
     

 

 

 

Total for modification 14 Activity

      $ 1,086,563.00   
     

 

 

 

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATION INTERNATIONAL CORPORATION

/s/ Patrick Lucy

   

/s/ Carol Frishman

(Signature)     (Signature)
Name:  

Patrick Lucy                                        date 9/20/12

    Name:  

Carol Frishman                                date 9/20/12

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Manager

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

 

SUBCONTRACT AGREEMENT P010022290 Modification 18

 

SUBCONTRACTOR:

 

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

  

SUBCONTRACT #:

 

   P010022290
  

MODIFICATION #:

 

   18
  

DPAS RATING:

 

   Not Rated
  

TYPE:

 

   FIRM FIXED PRICE
  

COMMERCIAL ITEMS

 

   (GOVERNMENT)

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

•    Modification Value:            $590,522.25

 

  

FUNDED:

 

   $6,161,534.26
   Ceiling VALUE:    $6,253,215.75

The purpose of this modification is to add incremental funding as shown below. (This is an increase in funding only and is not for additional scope of work).

Effective date of this modification is May 21, 2013.

The total funded amount is increased FROM $5,571,012.01 BY $590,522.25 TO $6,161,534.26 . The ceiling value remains $6,253,215.75 .

1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $6,253,215.75 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $6,161,534.26 including profit.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

s/s Patrick Lucy

   

s/s Carol Frishman

(Signature)     (Signature)
Name:  

Patrick Lucy                                                 date

    Name:  

Carol Frishman                                                 date

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Administrator

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1


LOGO

 

SUBCONTRACT AGREEMENT P010022290 Modification 19

 

SUBCONTRACTOR:

 

Pfenex Inc.

10790 Roselle Street, San Diego, CA

92121

  

SUBCONTRACT #:

 

   P010022290
  

MODIFICATION #:        19

 

  

DPAS RATING:

 

   Not Rated
  

TYPE:

 

   FIRM FIXED
  

PRICE COMMERCIAL ITEMS (GOVERNMENT)

 

Period of Performance:

 

Sep 11, 2009 thru Sep 21, 2014

  

•    Modification Value:

 

   $2,155,708.00
   TOTAL FUNDED:        $7,437,162.26
   Ceiling VALUE:    $8,408,923.75

The purpose of this modification is to increase the ceiling value and funding value for additional work as stated below.

Effective date of this modification is September 30, 2013.

As a result of this modification, the total ceiling value is increased FROM $ 6,253,215.75 BY $2,155,708.00 TO $8,408,923.75 . The total funded amount is increased FROM $6,161,534.26 BY $1,275,628.00 TO $7,437,162.26.

Statement of Work entitled “Evaluation of [*] Antigen Expression in Pfēnex Expression Technology™ and Process Manufacturing” and dated May 20, 2013 is herein incorporated into and made part of Subcontract No. P010022290 as additional work and is attachment 1 to this modification 19.

1.0 PRICE is modified to read as follows: The total not-to-exceed Ceiling Value of Subcontract No. P010022290 is $8,408,923.75 including profit. This subcontract is incrementally funded for work to be performed through September 21, 2014. The total FUNDING of Subcontract No. P010022290 is $7,437,162.26 , including profit.

This Milestone Activity will commence upon request of SAIC representative in writing only. Payments for this modification 19 will be made in accordance with the schedule as outlined below.

It is understood Payment terms are 50% upon commencement of task and 50% upon acceptance of task draft final report which includes results of a successful engineering run. A successful engineering run is defined as pilot scale execution of bench-scale process that does not experience any operator error and/or mechanical error that impacts the successful completion of the run. The product quality from the engineering run needs to be comparable to that of the smaller scale runs and suitable for pre-clinical testing. Master batch records, along with process and analytical data will be outlined in the final Stage 8 report.

The estimated pricing for this proposal is inclusive of costs for labor, supplies, materials and reports.

 

Stage

   Estimated
Timescale
   Price  

Stage 4: Fermentation Development

   8 weeks    $ 200,200   

Stage 5: Purification Development

   20 weeks    $ 652,960   

Stage 5 materials & service fees

      $ 160,000   

Stage 6: BDS Formulation Development

   4 weeks    $ 103,796   

Stage 7: Product-Specific Analytical Method SOP Development

   20 weeks    $ 237,468   

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 2


LOGO

 

Stage

   Estimated
Timescale
   Price  

Stage 7 materials & service fees

      $ 25,000   

Stage 8: Engineering Run (ER)

   4 Weeks

Assumes using
materials purchased
in Stage 5.

   $ 221,760 per ER   

Stage 9: Stability Study for material from Stage 8: Engineering Run

   16 weeks    $ 263,648   

Stage 10: Process Transfer and Training

   8 weeks    $ 260,876   

CMC Support

   3 weeks    $ 30,000   
     

 

 

 

Total Price:

      $ 2,155,708   
     

 

 

 

17.0 ORDER OF PRECEDENCE – is modified to read as follows:

The documents listed below are hereby incorporated by reference. In the event of an inconsistency or conflict between or among the provisions of this Subcontract, the inconsistency shall be resolved by giving precedence in the following order:

 

  1. Attachment I: Statement of Work and Schedule dated May 20, 2013, Mod 19.

 

  2. Statements of Work and Schedules as follows:

Modifications -15 dated 5/4/12, 14 dated 6/22/12, 13 dated 6/15/12, 12 dated 2/6/12, 6 dated 6/1/11, 5 dated 1/1/11, 4 dated 11/15/10, 2 dated 5/4/10 and original dated 5/11/11 respectively.

 

  3. Schedule A: Specific Terms and Conditions Form 9-932-072 (Rev. 9/25/06).

 

  4. Schedule B: U.S. Government Terms and Conditions, Part III – FAR Clauses Form 9-932-082 (Rev. 07/25/07).

 

  5. Attachment C: (Enclosure 2; (Rev. 4/2009) Property Administration Requirements For Subcontractors With An Adequate System Or Requisite Internal Controls.

All other Subcontract terms and conditions remain unchanged.

In witness whereof, the duly authorized representatives of Buyer and Seller have executed this Subcontract Modification on the dates shown.

 

PFENEX INC.     SCIENCE APPLICATIONS INTERNATIONAL CORPORATION

 

   

 

(Signature)     (Signature)
Name:  

Patrick Lucy                                                 date

    Name:  

Carol Frishman                                                 date

(Type or Print)     (Type or Print)
Title:  

Vice President of Business Development

    Title:  

Subcontracts Administrator

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 2 of 2


Statement of Work

Evaluation of [* ] Malaria Antigen Expression in Pf ēnex Expression Technology™

and Process Manufacturing

Malaria Vaccine Production and Support Services

May 20, 2013

Subcontract Modification

 

1. Scope of Work

Independently and not as an agent of SAIC, Pfenex shall furnish all of the necessary services, qualified personnel, materials, equipment, and facilities for the full development of a manufacturing process for the [*] clone using Pf ēnex Expression Technology™ and technical transfer of the process to a SAIC designated cGMP manufacturing facility with processing capabilities and equipment compatible with the upstream and downstream process developed by Pfenex. The process shall be suitable for a scale up, at a minimum, of a [*] scale and follow-on purification, upon transfer. As part of this project, Pfenex is required to provide related meeting support, reports, and deliverables as listed in Table 1 .

 

  1.1. SAIC will provide the following information and materials:

 

    Background literature/references relating to Rh5.

 

    Additional [*], if required.

 

    Shipping instructions for [*] and other materials.

 

2. Technical Requirements

As a follow-on to the successful production, testing, and selection of a [*] line under the original subcontract and Mod 12 which was composed of: (i)-Evaluation of Rh5 expression (Stage 1), (ii)-Fermentation assessment of Rh5 (Stage 2), (iii)-Rh5 purification (Stage 2A/Mod 12) and (iv)-Preparation and characterization of [*] (RCB) (Stage 3); SAIC now requires Pfenex to develop a manufacturing process suitable for a scale up, at a minimum, of a [*] scale and follow-on purification for the SAIC selected clone [*] and technical transfer of the process to a SAIC designated cGMP manufacturing facility with processing capabilities and equipment compatible with the upstream and downstream process developed by Pfenex.

 

  2.1. Stage 4: Fermentation Optimization of cell line [*]

 

  2.1.1. Pfenex shall apply computer-aided, statistically-based design of experiments (DoE) to examine fermentation parameters for [*] expression. Design and execute 2-level fractional factorial experiments to screen up to five (5) factors (e.g. pH and temperature) for [*] expression in an 8-unit multiplex 1L bioreactor system.

Please Note : Appropriate samples for yield determination and analysis will be collected throughout the fermentation runs.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 1 of 10


  2.1.2. Perform the appropriate analysis on selected pre- and post-induction samples taken from the fermentations.

 

  2.1.3. Use JMP statistics software to analyze the data. Based on the conclusions, design a confirmation round of experiments up to a total of 32-40 X 1L fermentations.

 

  2.1.4. Evaluate Rh5 titer and quality on selected samples utilizing ELISA and western blot analysis development from Stage 7 Product Specific Analytical Method Development .

 

  2.1.5. The optimized fermentation condition shall be confirmed in up to three rounds at 3 X 20L scale per round.

 

  2.1.6. The optimized fermentation shall produce material which can be subsequently purified to meet product quality and safety specifications required for human use when produced under cGMP conditions.

 

  2.1.7. A technical study report shall be issued following the completion of the work.

 

  2.1.7.1. Pfenex shall submit the optimized fermentation procedure/protocol to SAIC for review and approval.

 

  2.1.7.2. Document shall also contain, at a minimum, in process parameters examined, rational for parameters selected, and copies of the raw data.

 

  2.2. Stage 5: Purification Process Development

 

  2.2.1. Pfenex shall develop a cGMP ready downstream purification process.

 

  2.2.2. Pfenex shall perform up to six rounds of [*] working volume) fermentation runs to supply cell paste for the experiments outlined in this stage of work.

 

  2.2.3. Pfenex shall develop a downstream purification process based on lessons learned from Stage 2A (Rh5 research-grade purification strategy).

 

  2.2.4. Pfenex shall design and execute a fractional factorial design to optimize protein release and purity [*].

 

  2.2.5. Pfenex shall evaluate efficiency (throughput, purity, recovery) of bulk separation of [*].

 

  2.2.6. Pfenex shall develop centrifugation, clarification, and filter train that will permit the material containing Rh5 [*].

 

  2.2.7. Pfenex shall analyze samples taken throughout the primary recovery development for Rh5 yield and purity.

 

  2.2.8. Pfenex shall utilize the process intermediat e from 2.2.7 to design and execute a resin screen (microtiter plate scale) for the primary capture chromatography step. Up to [*] resins will be screened for the best conditions for capacity. The best two resins will be screened in a second round using up to [*] to determine selectivity.

 

  2.2.9. Pfenex shall compare screening leads from 2.2.8 using test gradients and method scouting at small scale and rank performance with an emphasis on determining operating parameters (e.g., capacity, resolution, and yield) for protein with that resin

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 2 of 10


  2.2.10. The primary column resin and associated conditions selected from 2.2.9 will be optimized further for chromatography scale up and implemented at pilot scale.

 

  2.2.11. Pfenex shall utilize the elution pool from 2.2.10 to design and execute a resin screen for the second chromatography step. Up to [*] will be screened for the best capacity and selectivity. The best resin will be screened in a second round using up to [*] for efficiency and selectivity.

 

  2.2.12. Pfenex shall compare screening leads from 2.2.11 using test gradients and method scouting at small scale and rank performance with an emphasis on determining operating parameters (e.g., capacity, resolution, and yield) for protein with that resin.

 

  2.2.13. The second column resin and associated conditions selected from 2.2.12 will be optimized further for chromatography scale up and implemented at pilot scale.

 

  2.2.14. Pfenex shall utilize the elution pool from 2.2.13 to design and execute a resin screen for the polishing chromatography step. Up to [*] will be screened for the best capacity and selectivity. The best resin will be screened in a second round using up to [*] for efficiency and selectivity.

 

  2.2.15. Pfenex shall compare screening leads from 2.2.14 using test gradients and method scouting at small scale and rank performance with an emphasis on determining operating parameters (e.g., capacity, resolution, and yield) for protein with that resin.

 

  2.2.16. The polishing column resin and associated conditions selected from 2.2.12 will be optimized further for chromatography scale up and implemented at pilot scale.

 

  2.2.17. Purified Rh5 from 2.2.16 will be buffer exchanged into the final drug substance buffer determined in Stage 6 using tangential flow filtration (TFF). TFF parameters will be optimized to minimize processing time while maintaining product quality.

 

  2.2.18. For each downstream unit operation, Pfenex shall conduct hold studies to determine process intermediate stability.

 

  2.2.19. Pfenex shall perform analysis during development that may include [*].

 

  2.2.20. Pfenex shall perform a pilot scale integrated purification run to confirm scale-up parameters and overall process performance.

 

  2.2.20.1. Pfenex shall collect and analyze intermediate samples taken during the integrated run for protein yield, purity and contaminant profile.

 

  2.2.20.2. Pfenex shall provide purified Rh5 produced from the integrated run to SAIC or its designee.

 

  2.2.20.3. Pfenex shall perform analysis of integrated run final material that may include [*].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 3 of 10


  2.2.21. Pfenex shall submit the developed purification process procedures and protocols to SAIC for review and approval before moving forward to engineering run ( Stage 8 ).

 

  2.2.21.1. Document shall also contain, at a minimum, processes examined, rational for processes selected, and copies of the raw data.

 

  2.2.22. Pfenex shall ship purified Rh5 generated during development to a SAIC designated facility; however, Pfenex may retain all or a portion of the material produced for subsequent studies.

 

  2.3. Stage 6: BDS Formulation Development

 

  2.3.1. With material generated from Stage 5 Purification Process Development, Pfenex shall screen and evaluate at a minimum [*] that are compatible with Rh5.

 

  2.3.1.1. Components/pH in the buffer systems should be suitable for human use and may include stabilizing excipients.

 

  2.3.1.2. Pfenex will measure compatibility of the buffer systems using SEC-HPLC and/or other stability indicating assays.

 

  2.3.2. Pfenex shall confirm the selected buffer systems to monitor quality changes of rRh5 using SEC-HPLC and SDS-PAGE.

 

  2.3.3. Pfenex shall perform a short-term stability monitoring of selected, suitable buffer systems(s) to monitor quality changes of Rh5 using SEC-HPLC and/or other stability indicating assays.

 

  2.3.3.1. Short term stability monitoring shall include the following temperature and time points:

 

Stress

  

Conditions

  

Time Point(s)

Temperature    -70°C; 5°C; 25°C; 40C    Day 0, 1, 2

 

  2.3.3.2. Repeated freeze/thaw stress in 3-cycles.

 

  2.3.4. Upon SAIC’s request, Pfenex shall provide Rh5 in the selected buffer system and concentration to SAIC for further testing

 

  2.3.5. Pfenex shall issue a final report. The report shall include an executive summary, detailed description of methods including system suitability controls, list of all raw materials and their source, results, conclusions, inventory of reagents provided by SAIC, and all raw data in PDF format.

 

  2.4. Stage 7: Product Specific Analytical Method Development

 

  2.4.1. Pfenex shall develop product specific in-process and final product analytical methods and provide standard operating procedures (SOPs) for each method.

Please Note: Method qualification may be performed as optional.

 

  2.4.2. Pfenex shall establish acceptance criteria and specifications in consultation with SAIC, where applicable, that will be the basis for release and stability monitoring. The specifications shall be appropriate for a Phase 1 clinical product.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 4 of 10


  2.4.3. For in-process testing of low purity fermentation and purification samples, the testing shall include: [*].

 

  2.4.4. For release testing of bulk drug substance, the testing shall include: [*], endotoxin, and suitable process specific assays such as detection of impurities.

 

  2.4.5. For characterization of bulk drug substance, the testing shall include: [*].

 

  2.4.6. Pfenex shall recommend and submit the developed analytical and characterization testing, including procedures, protocols, and their results, to SAIC for review and approval.

 

  2.4.7. (Optional) Analytical method qualification shall be performed on methods developed.

 

  2.4.7.1. Qualification protocols and report template shall be issued for review and approval

 

  2.4.7.2. Qualification report shall be issued and include data and summary tables.

 

  2.5. Stage 8: Engineering Run

 

  2.5.1. Pfenex shall perform a complete engineering run at the 20 L (10 L w/v) scale to ensure reproducibility of previously drafted procedures.

 

  2.5.2. Pfenex shall develop master batch production records (BPRs) for the engineering run that covers all of upstream and downstream process, and identifies where the in-process tests occur and what volume is removed for testing. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

  2.5.3. Pfenex shall submit the completed BPRs to SAIC upon the completion of the engineering run.

 

  2.5.4. Pfenex shall execute the release and characterization testing as accomplished in Stage 7 for the engineering run material.

 

  2.5.5. Pfenex shall set aside aliquots for the stability program described below, and ship the remaining purified Rh5 from the engineering run to a SAIC designated facility in aliquots to be determined at a later timepoint.

 

  2.5.6. (Optional) Pfenex may perform additional engineering run(s) if required by SAIC

 

  2.5.6.1. Pfenex shall develop master batch production records (BPRs) for the engineering run that covers all of upstream and downstream process, and identifies where the in-process tests occur and what volume is removed for testing. SAIC will be provided copies of the master BPRs for review and approval prior to use.

 

  2.6. Stage 9: Stability Program

 

  2.6.1. Pfenex shall conduct a non-GMP stability monitoring of the purified Rh5. Pfenex shall submit the stability monitoring plans for the engineering run to SAIC for review and approval.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 5 of 10


  2.6.2. The stability of purified Rh5 from the engineering run shall be evaluated for stability at conditions of -70°C, 2°C–8°C, 25°C/60% relative humidity (RH), and 40°C/75% RH at month-0, 1,2, and 3. Note: T=0 initial testing is covered in Stage 8: Engineering Run.

 

Method/Test

-70°C, 5°C, 25°C/60% relative humidity (RH), 40°C/75% RH

   Initial
Testing
(T=0)
   1 mo    2 mo    3 mo

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X    X

[*]

   X    X    X   

[*]

   X    X    X   

[*]

   X          X

 

  2.6.3. Stability monitoring assessment shall include: pH, SDS-PAGE/CGE, RP-HPLC, SE-HPLC, peptide mapping by mass spectrometry, intact mass, capillary isoelectricfocusing (CIEF), circular dichroism, Intrinsic fluorescence.

 

  2.6.4. A stability report shall be submitted to SAIC at each stability timepoint and include, at minimum, assays utilized with associated SOP, test results in table format, conclusion, trending data, and copies of raw data.

 

  2.7. Stage 10: Process Training and Transfer

 

  2.7.1. Pfenex shall train SAIC’s cGMP contract manufacture organization (CMO) on the manufacturing process and shall transfer the BPRs (master and completed) and analytical method SOPs.

 

  2.7.2. As part of the process training and transfer Pfenex shall conduct at least one successful training run.

 

  2.7.3. The process yield from the process training run shall be within acceptable scientific variation from the engineering run performed in Stage 8 .

 

  2.7.4. The process training run shall demonstrate within acceptable scientific variation reproducibility as compared to Stage 8 , in all up- and down-stream processes including: growth rate in fermentation, quantity and quality of Rh5 in lysate, in primary recovery, in each process step, and in final product.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 6 of 10


  2.7.5. Pfenex shall provide to SAIC and to SAIC designated CMO the RCB and a full process transfer package with all information necessary for the transfer of the manufacturing process.

 

  2.7.6. The full process transfer package shall include the following items:

 

  2.7.6.1. Bill of materials and suggested suppliers

 

  2.7.6.2. Detailed fermentation and purification process procedures (master BPRs)

 

  2.7.6.3. Listing of instruments/equipment

 

  2.7.6.4. Detailed testing procedures (SOPs)

 

  2.7.6.5. Technical specification for the bulk drug substance

 

  2.7.6.6. Health/Safety/Environment assessment of all materials and process

 

  2.7.6.7. Detailed characterization of purified protein/buffer and intermediates

 

  2.7.6.8. Stability testing plan and final report

 

  2.7.6.8.1. Research cell bank growth parameters and technical information

 

  2.7.6.8.2. Construct expression information and test results

 

  2.7.7. The process transfer and associated training records for the transfer to the clinical CMO shall be well documented and be provided to SAIC in the final report.

 

  2.8. CMC Support

 

  2.8.1. Pfenex shall provide support in reviewing CMC sections and documents related to IND submission including details of the cloning and development of the expression strain CS672-3057.

 

3. Quality Requirements

In addition to the Quality Requirements stated in the SOW, Pfenex shall execute a Quality Management Plan suitable for process development and technical transfer (see Section 10).

 

  3.1. Pfenex shall provide a scientific, technical, and administrative infrastructure to ensure quality control of all process development and technical transfer activities.

 

  3.2. The quality management plan shall include use of any materials, instruments/equipment, methods, procedures utilized in the process development and technical transfer.

 

  3.3. At a minimum, Pfenex shall ensure:

 

  3.3.1. Facilities in which SAIC’s materials are maintained in a safe and secure manner and allow limited access.

 

  3.3.2. Personnel have the necessary education and training in all procedures relevant to work assignments; training and qualifications are verified by leadership of Pfenex.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 7 of 10


  3.3.3. SOPs will be used to document policies and procedures. SOPs will be version controlled and approved by key personnel.

 

  3.3.4. An effective tracking/tracing system or procedure is in place for all materials and equipment used in this contract.

 

  3.3.5. Equipment calibration and maintenance are performed as required and are documented.

 

  3.4. The Quality Management Plan shall govern Pfenex’s commitment to quality and ensure that procedures addressing the following requirements are in place.

 

  3.4.1. SOPs

 

  3.4.2. Document/version control

 

  3.4.3. Equipment maintenance and repair

 

  3.4.4. Training: adherence of staff to required schedules

 

  3.4.5. Data management

 

  3.4.6. Record management system

 

  3.4.7. Safety plan

 

  3.4.8. Asset tracking and management

 

  3.4.9. Building and facility monitoring

 

  3.4.10. Adherence to Federal or other applicable regulatory requirements appropriate for work on this contract

 

  3.4.11. Operational deviations and failures will be investigated through root cause analysis, which will be documented.

 

  3.5. Cold/frozen and controlled temperature storage chambers have continuous monitors with alarms or are monitored at least every 4 hours by security staff. Any deviations will be immediately reported to Pfenex staff.

 

  3.6. Effective cold chain management practices are in place for the handling of materials, products and samples.

 

  3.7. Investigation are initiated upon incident discovery (excursion from written procedure, policy, or protocol). Upon request, copies results of investigations are submitted to SAIC for review.

 

  3.8. SAIC may schedule in-plant and other visits at Pfenex to audit quality of activities conducted in this contract.

 

4. Record Management Requirements

Pfenex shall maintain a record management system suitable for process development and technical transfer (see Section 10, Quality Management Plan).

 

  4.1. Pfenex shall have a record management system that permits detailed records to be made concurrently with the performances of each process development activity.

 

  4.2. Records and documents shall be created and maintained in a manner that allows version control, handling steps, tests, retests, investigations, data, and results.

 

  4.3. Record and document security systems shall be adequate to ensure confidentiality and privacy of proprietary information. Confidential or proprietary information shall be restricted to staff with a need for access and inspectors from regulatory agencies. Records shall be readily accessible for inspection by authorized personnel from SAIC.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 8 of 10


  4.4. Records and documents shall be maintained for a minimum of 5 years after the completion of process development and technical transfer. SAIC shall be contacted for disposal or transfer instructions at the end of a records storage period or at the end of the subcontract POP.

 

  4.5. Electronic records shall be backed up daily on a separate server or network. Weekly backups shall be stored on an appropriate media, e.g., CD, tape, and stored off-site.

 

  4.6. Corrections or changes in a record shall be made in accordance with a quality monitoring procedures suitable for managing process development and technical transfer.

 

  4.7. Unless alternate agreements are made, all raw data and laboratory notebooks related to this subcontract shall be made available to SAIC upon request.

Table 1. Deliverables to SAIC

 

Deliverable

  

Requirement

  

Item

  

Date*

  

Form

1    Technical    Purified Rh5 from process development    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
2    Technical    Purified Rh5 from engineering run    Within a week of completion    Sent to SAIC designee in proper shipping containers with a temperature monitor
3    Technical    Unused reagents provided by SAIC    Within 2 weeks of SAIC request    Sent to SAIC designee in proper shipping containers
4    Technical    Optimized fermentation procedure and protocols    Within 3 week of completion    PDF or Word document
5    Technical    Selected primary recovery method    Within 3 week of completion    PDF or Word document
6    Technical    Purification process procedures and protocols    Within 3 week of completion    PDF or Word document
7    Technical    Recommended analytical and characterization testing    Within 3 week of completion    PDF or Word document
8    Technical    Master BPRs for the engineering run    2 weeks prior to initiation    PDF or Word document

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 9 of 10


Deliverable

  

Requirement

  

Item

  

Date*

  

Form

9    Technical    Master BPRs for the second engineering run, etc    2 weeks prior to initiation    PDF or Word document
10    Technical    Completed BPRs for the engineering run    Within 3 week of completion    PDF or Word document
11    Technical    Completed BPRs for the second engineering run, etc    Within 3 week of completion    PDF or Word document
12    Technical    Stability monitoring plans for engineering run(s)    2 weeks prior to initiation    PDF or Word document
13    Technical    stability reports    3 week following each indicated time point    PDF or Word document
14    Technical    Full Process transfer package    4 weeks following completion of engineering run    PDF or Word document
15    Reporting    Biweekly Meeting and minutes    Meeting as scheduled, minutes within a week of the meeting    Telecom
16    Reporting    Monthly Reports    Due by the 8 th of each month during the performance of work efforts    PDF or Word document
17    Reporting    CMC Support    Final: 3 weeks after receipt of SAIC CMC sections provided for review    Draft: Word Document

 

* Days = Calendar days

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Page 10 of 10


LOGO

October 29, 2013

Pfenex Inc.

10790 Roselle Street

San Diego, CA 92121

 

Attention: Patrick Lucy, Vice President of Business Development and Marketing

 

Subject: Modification No. 20

 

Reference: (a) SAIC Subcontract P010022290

Dear Mr. Lucy :

In 2012, SAIC, Inc. announced plans to separate into two independent, publicly-traded companies. This separation was approved by the SAIC Board of Directors and will occur on 28 September 2013. The legacy company (SAIC, Inc.) will operate under the name Leidos, Inc., and will continue to use the original Home Office CAGE Code and DUNS Number.

Therefore, this unilateral modification, effective 28 September 2013, to Reference (a) Subcontract is issued to amend “Science Applications International Corporation” (SAIC) to “Leidos, Inc.”. All references in the Reference (a) Subcontract to “SAIC” are hereby amended to “Leidos.”

 

Sincerely,

s/s Carol Frishman

Carol Frishman
Subcontracts Administrator | Leidox, Inc.
Phone: 240-529-0438
Carol.c.frishman @ leidos.com

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

 

Page 1 of 1

The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or

privileged material. If you received this in error, please contact the sender and delete the material from any computer.

Exhibit 10.13

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].”

 

AWARD/CONTRACT      

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 350)

  u       

RATING

     N/A

 

PAGE    OF

PAGES

                1   65

2. CONTRACT  (Proc. Inst. Ident.)  NO.

HHSO100201000045C

     

3. EFFECTIVE DATE

See Block 20C (below)

 

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

OS37265

5. ISSUED BY     CODE         6 ADMINISTERED BY  (If other than Item 6)     CODE          

Office of Acquisition Management Contracts and Grants (AMCG)

DHHS, Contracts Division

330 Independence Ave., S.W. Room G640

Washington, D.C. 20201

 

  See Block 5            

7. NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code)

 

Pfenex Biopharmaceuticals.

Incorporated 5501 Oberlin Drive

San Diego, CA 92121

 

8. DELIVERY

    See Schedule

             

9/ DISCOUNT FOR PROMPT PAYMENT

 N/A

             
             
              10. SUBMIT INVOICES   ITEM
CODE DUNS No. 013603710               FACILITY CODE           ADDRESS SHOWN IN:  

 

See Section G

11. SHIP TO/MARK FOR       CODE     N/A   12. PAYMENT WILL BE MADE BY   CODE    N/A
                 

 

    See Block 5

 

                  See Block 5

13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: N/A

     ¨   10 U.S.C. 2304(c)(    )                                          ¨   41 U.S.C. 253(c)(    )

 

14. ACCOUNTING AND APPROPRIATION DATA

Object Class 25106

CAN#1990087 75-1011-0140        FY10            10,088,986

15A. ITEM NO.   15B. SUPPLIES/SERVICES     15C. UNIT PRICE         15D. AMOUNT          15E. UNIT PRICE     15F. AMOUNT

 Title: Development of rPA Expression Technology

 Performance Period. July 30, 2010 through December 12, 2011

 Contract Type: COST PLUS FIXED FEE

 BARDA-BAA-09-100-SOL-0010

 

FY 2010

Option 1

Option 2

Option 3

Option 4

Option 5

  $

$

$

$

$

$

10,088,986

  1,590,218

  1,025,164

  4,289,230

  1,084,229

  737,812

  

  

  

  

  

  

       
                                                                                              15G. TOTAL AMOUNT OF CONTRACT         u   10,088,986
16. TABLE OF CONTENTS
( ü )   SEC   DESCRIPTION   PAGE(S)   ( ü )   SEC  

DESCRIPTION

  PAGE(S)  
PART I - THE SCHEDULE   PART II - CONTRACT CLAUSES
x   A   SOLICITATION/CONTRACT FORM   1   x   I   CONTRACT CLAUSES     23
x   B   SUPPLIES OR SERVICES AND PRICE/COST   3   PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
x   C   DESCRIPTION / SPECS  WORK STATEMENT   7   x   J   LIST OF ATTACHMENTS   29
x   D   PACKAGING AND MARKING   11   PART IV - REPRESENTATIONS AND INSTRUCTIONS
x   E   INSPECTION AND ACCEPTANCE   11   ¨   K   REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS  
x   F   DELIVERIES OR PERFORMANCE   11              
x   G   CONTRACT ADMINISTRATION DATA   14   ¨   L   INSTRS., CONDS., AND NOTICES TO OFFERORS    
x   H   SPECIAL CONTRACT REQUIREMENTS   17   ¨   M   EVALUATION FACTORS FOR AWARD    
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

17. x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return 2  copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award/contract, (b) the solicitation, it any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)

 

  18. ¨ AWARD (Contractor is not required to sign this document) Your offer on Solicitation Number                                          , including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your offer, and (b) this award/contract No further contractual document is necessary.

19A. NAME AND TITLE OF SIGNER (Type or print)

 

    BERTRAND LIANG, MD, MBA, CEO

 

20A. NAME OF CONTRACTING OFFICER

 

    MICHAEL A. YOUNKINS AMCG, ASPR, OS, DHHS

19B. NAME OF CONTRACTOR

 

                         /s/ Bertrand C. Liang                    

 

 19C. DATE SIGNED

 

      7/27/2010

 

20B. UNITED STATES OF AMERICA

 

BY                     /s/ Michael A. Younkins                    

 

20C. DATE SIGNED

 

7/30/2010

(Signature of person authorized to sign)          

                  (Signature of Contracting  Officer)

 

       
NSN 7540-01-152-8069   28-107  

STANDARD FORM 26 (REV. 4-85)

PREVIOUS EDITION UNUSABLE   Computer Generated  

Prescribed by GSA

   

FAR (48 CFR) 53.214(a)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


CONTRACT TABLE OF CONTENTS

 

PART I — THE SCHEDULE

     3   

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

     3   

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

     7   

SECTION D - PACKAGING, MARKING AND SHIPPING

     11   

SECTION E - INSPECTION AND ACCEPTANCE

     11   

SECTION F - DELIVERIES OR PERFORMANCE

     11   

SECTION G - CONTRACT ADMINISTRATION DATA

     14   

SECTION H - SPECIAL CONTRACT REQUIREMENTS

     17   

PART II — CONTRACT CLAUSES

     23   

SECTION I - CONTRACT CLAUSES

     23   

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

     29   

SECTION J - LIST OF ATTACHMENTS

     29   

PART IV - REPRESENTATIONS AND INSTRUCTIONS

     30   

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

     30   

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


PART I- THE SCHEDULE

PART B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of the contract is to further develop a strain and process to manufacture recombinant protective antigen (rPA) for use in anthrax vaccine development using a microbial system.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

 

  a. The total estimated cost of the base period of performance contract is $[*].

 

  b. The total fixed fee for the base period of performance contract is $[*]. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer, and subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE 1.1 of this contract. Payment of fixed fee shall not be made in less than monthly increments.

 

  c. The total amount of the contract, represented by the sum of the total estimated cost plus fixed fee is $10,088,986.

 

  d. It is estimated that the amount currently allotted will cover performance of the contract through December 12, 2011.

 

CLIN

   Base Period   

Supplies/Services

   Quantity
(Units)
   Cost     Fixed Fee     Total Estimated
Cost Plus Fixed
Fee
 
0001    07/30/2010-

12/12/2011

  

[*]

   1 Job      [ *]      [ *]    $ 10,088,986   

ARTICLE B.3. OPTION PRICES

 

  a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.1. GENERAL CLAUSES FOR A COST PLUS FIXED FEE RESEARCH AND DEVELOPMENT CONTRACT, the contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of the contract.

 

  b. Pursuant to FAR Clause 52.217-7 (Options for Increased Quantity -Separately Priced Line Item), the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION CLAUSE Article in SECTION H of this contract. The estimated cost of the contract will be increased as set forth below:

OPTIONS

CLIN 1001 [*].

CLIN 2001 [*].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


CLIN

   Option Period   

Supplies/Services

   Quantity
(Units)
   Cost      Fixed
Fee
     Estimated
Cost
 
1001    12/13/2011-

04/11/2013

  

Stage 2b: [*]

   1 Job      [*]         [*]         [*]   
1002    04/12/2013-

09/17/2014

  

Stage, 2c: [*]

   1 Job      [*]         [*]         [*]   
2001    12/13/2011-

06/02/2013

  

Stage 3a: [*]

   1 Job      [*]         [*]         [*]   
2002    06/03/2013-

06/01/2014

  

Stage 3b: [*]

   1 Job      [*]         [*]         [*]   
2003    06/02/2014-

07/06/2015

  

Stage 3c: [*]

   1 Job      [*]         [*]         [*]   

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

 

  1. Acquisition, by purchase or lease, of any interest in real property;

 

  2. Special rearrangement or alteration of facilities;

 

  3 Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

 

  4. Travel to attend general scientific meetings;

 

  5. Unapproved foreign travel —Subject to the procedure specified under subparagraph b.2. below;

 

  6. Consultant costs;

 

  7. Subcontracts;

 

  8. Patient care costs;

 

  9. Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined and listed in the Contractor’s Guide for Control of Government Property), regardless of acquisition value.

 

  10. Printing Costs (as defined in the Government Printing and Binding Regulations).

 

  11. Light Refreshment and Meal Expenditures

Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Technical Representative (COTR), with a copy to

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


the Contracting Officer, at least six (6) weeks in advance of the event. The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshment and/or meal costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held somewhere other than a government facility, provide an explanation of why the event is not being held at a government facility.

b. Travel Costs

1. Domestic Travel

 

  a. Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed [*] during the base period (07/30/2010-12/12/2011) without the prior written approval of the Contracting Officer.

 

  b. Subject to the annual dollar limitation specified under B.4.b.1.a. above the Contractor shall invoice and be reimbursed for all travel costs in accordance with OMB Circular A-122 - “Cost Principles for Nonprofit Organizations.”

2. Foreign Travel

Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following: (a) meeting(s) and place(s) to be visited, with costs and dates; (b) name(s) and title(s) of Contractor personnel to travel and their functions in the contract project; (c) contract purposes to be served by the travel; (d) how travel of Contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of BARDA contract funds; (e) how such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and (f) what additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

a. Security Plan - Reserved

b. The Contractor agrees to provide data generated from this contract to the Contracting Officer upon request either in the form of an email attachment or via delivery to a secured Government eRoom.

c. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories (as applicable):

 

  1. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

 

  2. Fringe Benefits - Cite rate and amount

 

  3. Overhead - Cite rate and amount

 

  4. Materials & Supplies - Include detailed breakdown when unit price is over [*].

 

  5. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

 

  6. Consultant Fees - Identify individuals and amounts.

 

  7. Subcontracts - Attach subcontractor invoice(s).

 

  8. Equipment - Cite authorization and amount

 

  9. G&A - Cite rate and amount.

 

  10. Total Cost

 

  11. Fixed Fee

 

  12. Total CPFF

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

d. Reserved

e. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

f. Equipment

All Equipment purchases must receive prior written consent of the Contracting Officer. Upon review of quotes and supporting documentation the Contracting Officer may provide written consent for the equipment purchases.

g. Site Visits and Inspections

At the discretion of the USG and independent of activities conducted the Contractor, with ten (10) business days notice to the contractor, the USG reserves the right to conduct site visits and inspections on an as needed basis, including collection of product samples and intermediates held by the contractor, or subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall demonstrate cause for such visit and/or inspection. These visits shall be coordinated through the Prime Contractor. Under time-sensitive or critical situations, the USG reserves the right to suspend the 10 day notice to the Contractor. The areas included under the site visit could include, but are not limited to: security, regulatory and quality systems, and cGMP/GLP/GCP compliance.

h. Establishment of Indirect Cost Rates

In accordance with AMCG internal review at P f enex Biopharmaceuticals, Inc., letter dated June 18, 2010; the Contractor may bill indirect costs at the following rates:

Fringe Benefit Rate [*]

Overhead Rate [*]

The Government is not obligated to pay any additional amount over the above billing rates until such time that DCAA negotiates revised rates. In the event that the DCAA negotiated final indirect cost rates are less than the billing rates, the Government’s obligation shall be reduced to conform to the lower rates.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

6


SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated June 24, 2010 set forth in SECTION J-List of Attachments, attached hereto and made a part of the contract.

ARTICLE C.2. REPORTING REQUIREMENTS

Technical Reports

In addition to those reports required by the other terms of this contract, the Contractors shall prepare and submit the following reports in the manner state below and in accordance with the DELIVERIES Article in SECTION F of this contract.

1. Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

A cover page that includes the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission;

SECTION I - An introduction covering the purpose and scope of the contract effort;

SECTION II - PROGRESS

SECTION II Part A: OVERALL PROGRESS-A description of overall progress;

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating, and managing subcontractor performance);

SECTION II Part C: TECHNICAL PROGRESS-For each activity, document the results of work completed and cost incurred during the period covered in relation to proposed progress, effort and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the contract. The report shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress, why the differences have occurred and what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project;

SECTION II Part D; PROPOSED WORK-A summary of work proposed for the next reporting period and preprints/reprints of papers and abstracts.

A Monthly Progress Report will not be required in the same month that the Quarterly or Annual Technical Progress Report is submitted.

2. Quarterly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full quarter of performance plus any fractional part of the initial quarter. Thereafter, the reporting period shall consist of each calendar quarter.

The Contractor shall submit a Quarterly Progress Report on or before the 15 th calendar day following the last day of each reporting period and shall include the following:

A cover page that includes the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission;

SECTION I - An introduction covering the purpose and scope of the contract effort;

SECTION II - PROGRESS

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

7


SECTION II Part A: OVERALL PROGRESS-A description of overall progress;

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating, and managing subcontractor performance);

SECTION II Part C: TECHNICAL PROGRESS-For each activity, document the results of work completed and cost incurred during the period covered in relation to proposed progress, effort and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the contract. The report shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress, why the differences have occurred and what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project;

SECTION II Part D; PROPOSED WORK- A summary of work proposed for the next reporting period; and preprints/reprints of papers, abstracts and a current GANTT chart. A Quarterly Progress Report will not be required in the same month that the Annual Progress Report is submitted.

a. Draft Final Technical Progress Report and Final Technical Progress Report

These reports are to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Report and Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract. The Draft Final Technical Progress Report shall be submitted one hundred twenty (120) calendar days before completion date of the contract and the Revised Final Technical Progress Report shall be submitted at sixty (60) calendar days before the completion date of the contract. The report shall conform to the following format:

(1) Cover page to include the contract number, contract title, performance period covered, Contractor’s name and address, telephone number, fax number, e-mail address and submission date;

(2 ) SECTION I: EXECUTIVE SUMMARY-Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.

(3) SECTION II: RESULTS-A detailed description of the work performed, the results obtained, and the impact of the results on the scientific and/or public health community, including a listing of all manuscripts (published and in preparation) and abstracts presented during the entire period of performance, and a summary of all inventions.

Draft Final Technical Progress Report : The Contractor is required to submit the Draft Final Technical Progress Report to the Contracting Officer’s Technical Representative and Contracting Officer. This report is due 120 calendar days before the completion date of the contract. The Contracting Officer’s Technical Representative and Contracting Officer will review the Draft Final Technical Progress Report and provide the Contractor with comments within 45 calendar days after receipt.

Final Technical Progress Report : The Contractor will deliver the final version of the Final Technical Progress Report on or before the completion date of the contract.

b. Summary of Salient Results

The Contractor shall submit, with the Final Technical Progress Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

c. Audit Reports

Within thirty (30) calendar days of an audit related to conformance to FDA regulations and guidance, including adherence to GLP, GMP, or GCP guidelines, the Contractor shall provide copies of the audit report and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

8


d. Clinical Trial Protocols

BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-funded clinical trials. Therefore, as described in the NIAID Clinical Terms of Award ( http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf ), the Contractor shall develop a protocol for each clinical trial and submit all protocols and protocol amendments for approval by the BARDA Contracting Officer’s Technical Representative. Important information regarding performing human subjects research is available at http://www3.niaid.nih.gov/healthscience/clinicalstudies/ .

Any updates to technical reports are to be addressed in the Monthly, Quarterly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Technical Representative or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

e. Other Reports/Deliverables

(1) Copies of FDA Correspondence and Meeting Summaries

(a) For any formal meeting with the FDA, the contractor shall forward initial draft minutes and subsequently final meeting minutes appropriately formatted within thirty (30) calendar days of the FDA meeting to the BARDA Contracting Officer’s Technical Representative.

(b) The contractor shall forward the final draft minutes of any informal meeting with the FDA to BARDA.

(c) The contractor shall forward the dates and times of any meeting with the FDA to BARDA at least 30 days prior to the meeting and make arrangements for appropriate BARDA staff to attend FDA meetings.

(d) The contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA. The contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the contractor.

(2) Technology Transfer

Technology packages developed under the contract that include complete protocols and critical reagents developed and/or improved with contract funding must be submitted at the request of the BARDA Contracting Officer’s Technical Representative. See FAR clause 52.227-11 (Patent Rights-Ownership by the Contractor).

(3) Institutional Biosafety Approval

The Contractor shall provide documentation of materials submitted for Institutional Biosafety Committee Review and documentation of approval of experiments at the request of the BARDA Contracting Officer’s Technical Representative.

(4) Study/Experiment/Test Plans

The contractor shall submit all study/experiment/test plans, designs, and protocols upon request by the COTR .

(5) Data

The contractor shall provide raw data or specific analysis of data generated with contract funding at the request of the BARDA Contracting Officer’s Technical Representative. See FAR clause 52.227-14 (Rights in Data-General).

(6) Meeting Minutes

The Contractor shall provide an electronic copy of conference call meeting minutes/summaries to the BARDA Contracting Officer’s Technical Representative, Contracting Officer and Contracting Specialist within seven (7) calendar days after the conference call is held.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

9


(7) Audits/Site Visits

AMCG/BARDA Audits

The United States Government (USG) reserves the right to conduct an audit of the Contractor with 48 hours notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractors. At the discretion of the USG and independent of testing conducted by the Contractor, AMCG/BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractors.

ARTICLE C.3. SUBJECT INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 2207, MSC 7987, Bethesda, Maryland 20892-7987 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract. See also FAR clause 52.227-11 (Patent Rights-Ownership by the Contractor).

Reports and documentation submitted to the Contracting Officer shall be sent to the following address:

Contracting Officer

Michael Younkins

Office of Acquisitions Management, Contracts, and Grants (AMCG)

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, “Interagency Edison,” an electronic invention reporting system has been developed. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov ), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

ARTICLE C.4. TWICE MONTHLY CONFERENCE CALLS

A conference call between the Contracting Officer’s Technical Representative and the principal investigator shall occur bi-monthly or as directed by the Contracting Officer’s Technical Representative. During this call the principal investigator will discuss the activities during the reporting period, any problems that have arisen and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month. The principal investigator may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Technical Representative.

ARTICLE C.5. PROJECT MEETINGS

The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Technical Representative. These meetings may include face-to-face meetings with BARDA/AMCG in Washington, D.C. and at work sites of the Contractor and its subcontractors. Such meetings may include, but are not limited to, meetings of the Contractor (and subcontractors invited by the Contractor) to discuss study designs, site visits to the Contractor’s and subcontractor’s facilities, and meetings with the

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

10


Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor must provide data, reports, and presentations to groups of outside experts and USG personnel as required by the Contracting Officer’s Technical Representative in order to facilitate review of contract activities.

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E - INSPECTION AND ACCEPTANCE

1. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

2. For the purpose of this SECTION, the designated Contracting Officer’s Technical Representative is the authorized representative of the Contracting Officer.

3. Inspection and acceptance will be performed at:

Biomedical Advanced Research and Development Authority (BARDA)/ Office of Acquisition

Management, Contracts, and Grants (AMCG)

Office of the Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

330 Independence Avenue, S.W., Room G644

Washington, D.C. 20201

4. The contract incorporates the following clause by reference with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement

(May 2001). (Note: Work is deemed acceptable 90 days after delivery.)

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The base period of performance of this contract shall be from July 30, 2010 through December 12, 2011.

b. If the Government exercises its options pursuant to the OPTION CLAUSE Article in Section H of the contract the period of performance will be increased as listed below:

 

CLIN

   Option Period   

Supplies/Services

   Quantity
(Units)
   Cost     Fixed
Fee
    Estimated
Cost
 
1001    12/13/2011-

04/11/2013

  

Stage 2b: [*]

   1 Job      [ *]      [ *]      [ *] 
1002    04/12/2013-

09/17/2014

  

Stage 2c: [*]

   1 Job      [ *]      [ *]      [ *] 
2001    12/13/2011-

06/02/2013

  

Stage 3a: [*]

   1 Job      [ *]      [ *]      [ *] 
2002    06/03/2013-

06/01/2014

  

Stage 3b: [*]

   1 Job      [ *]      [ *]      [ *] 
2003    06/02/2014-

07/06/2015

  

Stage 3c: [*]

   1 Job      [ *]      [ *]      [ *] 

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

11


ARTICLE F.2. DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract.

 

Item

 

Description

  

Quantity

  

Addresses

  

Delivery Schedule

Technical Progress Reports

1)   Monthly Progress Report    2 electronic   

CO: (1) electronic copy

 

COTR: One (1) electronic

   The 15 th calendar day of each month following the first full month of the contract award. The Monthly Progress Report will not be required on months when an Annual or Quarterly Progress Report is due.
2)   Quarterly Progress Report    2 electronic    Same as CO and COTR above    15 th calendar day of the month following the end of each 3 month performance period. The Quarterly Progress Report will not be required on months when an Annual Progress Report is due.
4)   Draft Final Technical Progress Report    2 electronic    Same as CO and COTR above    120 calendar days before the completion date of the contract
5)   Final Technical Progress Report    2 electronic    Same as CO and COTR above    On or before the expiration date of the contract
6)   Summary of Salient Results    2 electronic    Same as CO and COTR above    On or before the expiration date of the contract

Other Technical Reports

7)   Audit Reports    2 electronic    Same as CO and COTR above    Within 30 Calendar days of the audit
8)   RCB Characterization Report    2 electronic    Same as CO and COTR above    Within 30 Calendar days of completing RCB Characterization
9)   MCB/WCB Characterization Report    2 electronic    Same as CO and COTR above    Within 30 Calendar days of completing MCB/WCB Characterization
10)   Stage milestone reports (and addendums)    2 electronic    Same as CO and COTR above    60 calendar days before the completion of the milestone (or option period)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

12


Other Reports

11)

  FDA Correspondence and Meeting Summaries    1 electronic    Same as COTR    Within 30 calendar days of receiving correspondence or meeting with the FDA

12)

  Invention Report Annual Utilization Report    2 electronic   

1 electronic to OPERA.

 

CO: 1 electronic

   Due on or before the 30m of the month following each anniversary date of the contract.

13)

  Final Invention Report    2 electronic   

1 electronic to OPERA.

1 CO: 1 electronic

   Due on or before the completion date of the contract.

b. The above items shall be addressed and delivered to: Contracting Officer’s address:

 

Contracting Officer’s address:

    

AMCG

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

Contracting Officer’s Technical Representative’s address:     

BARDA

330 Independence Avenue, S.W.

Room G644

Washington, D.C. 20201

See G.1. for e-mail address

BARDA Security Specialist  

Office of the Assistant Secretary for Preparedness and Response

Office of Public Health Emergency Medical Countermeasures

409 3 rd Street, S.W. Suite 320

Washington, DC 20201

E-mail: james.graham@hhs.gov

Address for the Extramural Inventions and Technology Resources Branch (EITRB), Office of Biodefense Research Affairs:
 

OPERA

NIH

6705 Rockledge Drive

Room 1040-A

MSC 7980

Bethesda, Maryland 20892-7980

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

The contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: httb://www.acouisition.gov/comp/far/index.html

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

13


FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)

The following Contracting Officer’s Technical Representative (COTR) will represent the Government for the purpose of this contract:

Brian Dattilo, Ph.D.

Contracting Officer Technical Representative

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

Mailing Address:

330 Independence Avenue, SW, Room G640

Washington, D.C. 20201

(202) 260-0462 (Office)

Brian.Dattilo@hhs.gov

Alternate COTR:

Jonathan Seals

Acting Director Strategic Science and Technology Division

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response

Department of Health and Human Services

Mailing Address:

330 Independence Avenue, SW, Room G640

Washington, D.C. 20201

(202)2260-1010 (Office)

Jonathan.Seals@hhs.gov

The COTR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Government may unilaterally change its COTR designation.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

14


ARTICLE G.2. CONTRACTING OFFICER

 

a. The Contracting Officer (CO) is the only individual who can legally commit the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract.

 

b. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

 

c. No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, shall be considered grounds for deviation from this contract. The Government may unilaterally change its CO designation

ARTICLE G.3. KEY PERSONNEL, HHSAR 352.270-5 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual is considered to be essential to the work being performed hereunder:

 

Name

  

Title

   Principal Investigator
   Deputy PI & Fermentation
   Administrative Contact

[*]

   Analytical Biochemistry
   Downstream Processing
   Molecular Biology
   LBERI Animal Studies Principal Investigator

ARTICLE G.4. INVOICE SUBMISSION

The Contractor shall submit one electronic copy of the contract invoices to the address shown below:

 

DHHS/OS/ASPR/AMCG    DHHS/OS/ASPR/AMCG
Attn: Contracting Officer    Attn: Contract Specialist
330 Independence Ave., S.W.    Email: Jeannett.Jackman@hhs.gov
Room G640   
Washington, D.C. 20201   
E-mail: Michael.Younkins@ahhs.gov   

ARTICLE G.5. CONTRACT FINANCIAL REPORT

 

  a. Financial reports on the attached Financial Report of Individual Project/Contract shall be submitted by the Contractor in accordance with the instructions for completing this form, which accompany the form, in an original and one electronic copy, not later than the 30th working day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are discussed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.

 

  b. Unless otherwise stated in that part of the instructions for completing this form, entitled “ PREPARATION INSTRUCTIONS ,” all columns A through J, shall be completed for each report submitted.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

15


  c. The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a quarterly basis.

 

  d. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

 

  e. The listing of expenditure categories to be reported is incorporated within the Attachment entitled, “Financial Report of Individual Project/Contract,” located in SECTION J and made a part of this contract.

 

  f. The Government may unilaterally revise the “Financial Report of Individual Project/Contract” to reflect the allotment of additional funds.

ARTICLE G.6. INDIRECT COST RATES

a. In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Mr. Andrew Sandberg

AMCG

330 Independence Ave., S.W.

Room G640

Washington, D.C. 20201

b. These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.7. GOVERNMENT PROPERTY

 

  a. In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated into this contract by reference. This document can be accessed at:

htto://www.hhs.gov/oamp/policies/contractors guide for control of gov property.pdf

Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

 

  b. Notwithstanding the provisions outlined in the HHS Publication, “Contractor’s Guide for Control of Government Property,” which is incorporated in this contract in paragraph a. above, the Contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

 

  c. Title will vest in the Government for equipment purchased as a direct cost.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

  a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, an interim evaluation shall be submitted December 31, 2011.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

16


Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

 

  b. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address: http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4 (January 2006)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Office of Public Health and Science (OPHS). The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

c. If at any time during the performance of this contract, the Contracting Officer determines, in consultation with the OHRP, OPHS, ASH, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OHRP, OPHS, ASH, terminate this contract in a whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Health and Human Services Human Subject Assurances.

(End of clause)

ARTICLE H.2. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable Federal, State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

17


Provision by the Contractor to the Contracting Officer of a properly completed “Protection of Human Subjects Assurance ldentification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310).

ARTICLE H.3. RESEARCH INVOLVING HUMAN FETAL TISSUE

All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/quide/notice-files/not93-235.html and any subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.

The Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.

ARTICLE H.4. NEEDLE EXCHANGE

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

a. Before undertaking performance of any contract involving animal related activities, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 through 2.11, or from a source that is exempt from licensing under those sections.

c. The Contractor agrees that the care and use of any live vertebrate animals used or intended for use in the performance of this contract will conform with the PHS Policy on Humane Care of Use of Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq . and 9 CFR Subchapter A, Parts 1 - 4). In case of conflict between standards, the more stringent standard shall be used.

d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved PHS Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.

(End of Clause)

ARTICLE H.6. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy may be accessed at: http://grants1.nih.qov/grants/olaw/references/phspol.htm.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

18


ARTICLE H.7. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN RIMATES

All Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with Nonhuman Primates,” located at the following URL:

http/www1.od.nih.gov/oma/manualchapters/intramura1/3044-2/

ARTICLE H.8. IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data determined by DHHS to be relevant to this contract. The contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

ARTICLE H.9. INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS

Registration with the U. S. Dept. of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes. USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.), http //www.nal. usda.gov/awic/legislat/awa.htm .

The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW) http://qrants2.nih.qov/qrants/olaw/olaw.htm . An essential requirement of the PHS Policy http://qrants2.nih.qov/qrants/olaw/references/phspol.htm is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. Public Health Service.

The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readinqroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/leqislat/usdalegl.htm issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.orq is a professional organization that inspects and evaluates programs of animal care for institutions at their request. Those that meet the high standards are given the Accredited status. As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable. AAALAC uses the Guide as their primary evaluation tool. They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching . It is published by the Federated of Animal Science Societies http://www.fass.org .

ARTICLE H.10. APPROVAL OF REQUIRED ASSURANCE BY OLAW

Under governing regulations, federal funds which are administered by the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (BARDA) shall not be expended by the contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office of Laboratory Animal Welfare (OLAW). Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities which do not directly involve live vertebrate animals (i.e. are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by the contractor or individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional information regarding OLAW may be obtained via the Internet at http.//qrants2.nih.gov/qrants/olaw/references/phspol.htm

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

19


ARTICLE H.11. REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING THE POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

Work involving select biological agents or toxins shall not be conducted under this contract until the contractor and any affected subcontractor(s) are granted a certificate of registration or are authorized to work with the applicable select agents.

For prime or subcontract awards to domestic institutions who possess, use, and/or transfer Select Agents under this contract, the institution must complete registration with the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work involving Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR 73, if the final registration certificate is denied.

For prime or subcontract awards to foreign institutions who possess, use, and/or transfer Select Agents under this contract, the institution must provide information satisfactory to the Government that a process equivalent to that described in 42 CFR 73 ( http://www.cdc.gov/od/sap/docs/42cfr73.pdf ) for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The contractor must provide information addressing the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations and policies equivalent to 42 CFR 73 . The Government will assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR Part 73 . When requested by the contracting officer, the contractor shall provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select Agents. This includes summaries of safety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, the contractor must provide the names of all individuals at the foreign institution who will have access to the Select Agents and procedures for ensuring that only approved and appropriate individuals have access to Select Agents under the contract.

Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program Web site at http://www.cdc.qov/od/sa

ARTICLE H.12. EXPORT CONTROL NOTIFICATION

Offerors are responsible for ensuring compliance with all export control laws and regulations that maybe applicable to the export of and foreign access to their proposed technologies. Offerors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).

ARTICLE H.13. OPTION CLAUSE

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I, ARTICLE 1.1., the contract will consist only of the base period and/or any option period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract, the Government may, by unilateral contract modification, require the contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST PLUS FIXED FEE price of the contract as noted in Article B.3 in SECTION B of this contract.

ARTICLE H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in AMCG funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htipsa@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

20


ARTICLE H.15. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

ARTICLE H.16 CONFLICT OF INTEREST

a. The Contractor warrants that to the best of its knowledge and belief except as otherwise disclosed, no actual or apparent organizational, financial or employee conflict of interest exists as defined below:

(i) a situation in which the nature of work under a Government contract and a Contractor’s organization and any of its affiliate organizations or their successors in interest (hereinafter collectively referred to as the “Contractor”), financial, contractual or other interests are such that the appearance of the Contractor’s objectivity in performing the contract work may be impaired, may otherwise result in a biased work product, or may result in the contractor being given an unfair competitive advantage; or

(ii) a financial interest or relationship, professional or otherwise, of an employee, subcontractor employee, or consultant (hereinafter referred to as “employee”) with an entity that may actually impair or have the appearance of impairing the objectivity of the employee in performing the contract work, or

(iii) an employee has had, currently has, or is reasonably expected to have, official responsibilities with an outside organization, or some other financial interest or business affiliation, such that a reasonable person with knowledge of the relevant facts might question the employee’s objectivity/impartiality in performing the contract.

(iv) For purposes of paragraphs a(i) - (a)(iii), the financial interests and business affiliations of the employee’s spouse, minor children, and business partners are imputed to the employee.

Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational, financial or employee conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions, which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational, financial or employee conflict of interest. If the Contractor was aware of a potential organizational, financial or employee conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

ARTICLE H.17. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (Jan 2006)

The Contractor is hereby notified of the restrictions on the use of Department of Health and Human Service’s funding for lobbying of Federal, State and Local legislative bodies.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

21


Section 1352 of Title 31, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, as set forth in HHSAR 352.270-10 “Anti-Lobbying” (January 2006), the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

(End of Clause)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

22


PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE 1.1. General Clauses for a Cost-Reimbursement Research and Development Contract

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

FAR

CLAUSE NO.

  

DATE

  

TITLE

52.202-1    Jul 2004    Definitions (Over $100,000)
52.203-3    Apr 1984    Gratuities (Over $100,000)
52.203-5    Apr 1984    Covenant Against Contingent Fees (Over $100,000)
52.203-6    Sep 2006    Restrictions on Subcontractor Sales to the Government (Over $100,000)
52.203-7    Jul 1995    Anti-Kickback Procedures (Over $100,000)
52.203-8    Jan 1997    Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)
52.203-10    Jan 1997    Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
52.203-12    Sep 2007    Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
52.203-13    Apr 2010    Contractor Code of Business Ethics and Conduct
52.203-14    Dec 2007    Display of Hotline Poster(s)
52.204-4    Aug 2000    Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
52.204-7    Apr 2008    Central Contractor Registration
52.209-6    Sep 2006    Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
52.212-4    Mar 2009    Contract Terms and Conditions-Commercial Items
52.215-2    Mar 2009    Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over $100,000 funded exclusively with non-Recovery Act funds.]
52.215-8    Oct 1997    Order of Precedence - Uniform Contract Format
52.215-10    Oct 1997    Price Reduction for Defective Cost or Pricing Data (Over $650,000)
52.215-12    Oct 1997    Subcontractor Cost or Pricing Data (Over $650,000)
52.215-14    Oct 1997    Integrity of Unit Prices (Over $100,000)
52.215-15    Oct 2004    Pension Adjustments and Asset Reversions
52.215-18    Jul 2005    Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
52.215-19    Oct 1997    Notification of Ownership Changes
52.215-21    Oct 1997    Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data - Modifications
52.216-7    Dec 2002    Allowable Cost and Payment
52.216-8    Mar 1997    Fixed Fee
52.217-9    Mar 2000    Option to Extend the Term of the Contract
52.219-8    May 2004    Utilization of Small Business Concerns (Over $100,000)
52.219-9    Apr 2008    Small Business Subcontracting Plan (Over $550,000, $1,000,000 for Construction)
52.219-16    Jan 1999    Liquidated Damages - Subcontracting Plan (Over $550,000, $1,000,000 for Construction)
52.222-1    Jun 2003    Convict Labor
52.222-21    Feb 1999    Prohibition of Segregated Facilities
52.222-26    Mar 2007    Equal Opportunity
52.222-35    Sep 2006    Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000)
52.222-36    Jun 1998    Affirmative Action for Workers with Disabilities
52.222-37    Sep 2006    Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

23


FAR

CLAUSE NO.

  

DATE

  

TITLE

52.222-39    Dec 2004    Notification of Employee Rights Concerning Payment of Union Dues or Fees.
52.222-50    Feb 2009    Combating Trafficking in Persons
52.222-54    May 2001    Drug-Free Workplace
52.223-14    Aug 2003    Toxic Chemical Release Reporting (Over $100,000)
52.225-1    Feb 2009    Buy American Act - Supplies
52.225-13    Jun 2008    Restrictions on Certain Foreign Purchases
52.227-1    Dec 2007    Authorization and Consent, Alternate I (Apr 1984)
52.227-2    Dec 2007    Notice and Assistance Regarding Patent and Copyright Infringement
52.227-11    Dec 2007    Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
52.227-14    Dec 2007    Data Rights Alt II
52.229-3    Apr 2003    Federal, State and Local Taxes
52.232-9    Apr 1984    Limitation on Withholding of Payments
52.232-17    Oct 2008    Interest (Over $100,000)
52.232-20    Apr 1984    Limitation of Cost
52.232-23    Jan 1986    Assignment of Claims
52.232-25    Oct 2008    Prompt Payment, Alternate I (Feb 2002)
52.232-33    Oct 2003    Payment by Electronic Funds Transfer - Central Contractor Registration
52.233-1    Jul 2002    Disputes
52.233-3    Aug 1996    Protest After Award, Alternate I (Jun 1985)
52.233-4    Oct 2004    Applicable Law for Breach of Contract Claim
52.242-1    Apr 1984    Notice of Intent to Disallow Costs
52.242-3    May 2001    Penalties for Unallowable Costs (Over $650,000)
52.242-4    Jan 1997    Certification of Final Indirect Costs
52.242-13    Jul 1995    Bankruptcy (Over $100,000)
52.243-2    Aug 1987    Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2    Jun 2007    Subcontracts, Alternate I (June 2007)
52.244-5    Dec 1996    Competition in Subcontracting (Over $100,000)
52.244-6    Apr 2010    Subcontracts for Commercial Items
52.245-1    Jun 2007    Government Property
52.245-9    Jun 2007    Use and Charges
52.246-23    Feb 1997    Limitation of Liability (Over $100,000)
52.249-6    May 2004    Termination (Cost-Reimbursement)
52.249-14    Apr 1984    Excusable Delays
52.253-1    Jan 1991    Computer Generated Forms

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

HHSAR

CLAUSE NO.

  

DATE

  

TITLE

352.202-1    Jan 2006    Definitions - with Alternate paragraph (h) (Jan 2006)
352.216-70    Jan 2006    Additional Cost Principles
352.224-70    Jan 2006    Privacy Act
352.228-7    Dec 1991    Insurance - Liability to Third Persons
352.242-73    Jan 2006    Withholding of Contract Payments
352.233-71    Jan 2006    Litigation and Claims
352.242-74    Apr 1984    Final Decisions on Audit Findings
352.242-70    Jan 2006    Key Personnel
352.227-70    Jan 2006    Publications and Publicity
352.203-70    Jan 2006    Anti-Lobbying (Over $100,000)

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT-Rev. 03/2009].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

24


ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

(Reserved)

ARTICLE I.3. Additional Contract Clauses

This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

1. FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

2. FAR Clause 52.219-25, Small Disadvantaged Business Participation Program–Disadvantaged Status and Reporting (April 2008).

3. FAR Clause 52.227-16, Additional Data Requirements (June 1987).

b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:

3. HHSAR Clause 352.223-70, Safety and Health (January 2006).

4. HHSAR Clause 352.224-70, Privacy Act (January 2006).

3. HHSAR Clause 352.201-70, Paperwork Reduction Ac t (January 2006).

4. HHSAR Clause 352.270-4, Protection of Human Subjects (January 2006)

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

  a. FAR Clause 52.219-28, Post-Award Small Business Program Representation (April 2009).

(a) Definitions As used in this clause—

Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

Small business concern means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause. Such a concern is “not dominant in its field of operation” when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged. In determining whether dominance exists, consideration shall be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature of business activity.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

25


(b) If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall represent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following:

(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

(3) For long-term contracts—

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and (ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

(c) The Contractor shall represent its size status in accordance with the size standard in effect at the time of this representation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at http://www.sba.govicontractingopportunities/officials/size/index.html

(d) The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees.

(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in the Online Representations and Certifications Application and its data in the Central Contractor Registration, as necessary, to ensure that they reflect the Contractor’s current status. The Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update.

(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in ORCA, or does not have a representation in ORCA for the NAICS code applicable to this contract, the Contractor is required to complete the following representation and submit it to the Contracting Office, along with the contract number and the date on which the representation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code assigned to contract number.

[Contractor to sign and date and insert authorized signer’s name and title].

(End of clause)

b. FAR Clause 52.222-39, Notification Of Employee Rights Concerning Payment Of Union Dues Or Fees (December 2004)

(a) Definition . As used in this clause —

United States means the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.

(b) Except as provided in paragraph (e) of this clause, during the term of this contract, the Contractor shall post a notice, in the form of a poster, informing employees of their rights concerning union membership and payment of union dues and fees, in conspicuous places in and about all its plants and offices, including all

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

26


places where notices to employees are customarily posted. The notice shall include the following information (except that the information pertaining to National Labor Relations Board shall not be included in notices posted in the plants or offices of carriers subject to the Railway Labor Act, as amended (45 U.S.C. 151-188)).

Notice to Employees

Under Federal law, employees cannot be required to join a union or maintain membership in a union in order to retain their jobs. Under certain conditions, the law permits a union and an employer to enter into a union-security agreement requiring employees to pay uniform periodic dues and initiation fees. However, employees who are not union members can object to the use of their payments for certain purposes and can only be required to pay their share of union costs relating to collective bargaining, contract administration, and grievance adjustment.

If you do not want to pay that portion of dues or fees used to support activities not related to collective bargaining, contract administration, or grievance adjustment, you are entitled to an appropriate reduction in your payment. If you believe that you have been required to pay dues or fees used in part to support activities not related to collective bargaining, contract administration, or grievance adjustment, you may be entitled to a refund and to an appropriate reduction in future payments.

For further information concerning your rights, you may wish to contact the National Labor Relations Board (NLRB) either at one of its Regional offices or at the following address or toll free number:

National Labor Relations Board

Division of Information

1099 14th Street, N.W.

Washington, DC 20570

1-866-667-6572

1-866-316-6572 (TTY)

To locate the nearest NLRB office, see NLRB’s website at http://www.nlrb.gov .

(c) The Contractor shall comply with all provisions of Executive Order 13201 of February 17, 2001, and related implementing regulations at 29 CFR part 470, and orders of the Secretary of Labor.

(d) In the event that the Contractor does not comply with any of the requirements set forth in paragraphs (b), (c), or (g), the Secretary may direct that this contract be cancelled, terminated, or suspended in whole or in part, and declare the Contractor ineligible for further Government contracts in accordance with procedures at 29 CFR part 470, Subpart B - Compliance Evaluations, Complaint Investigations and Enforcement Procedures. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 470, which implements Executive Order 13201, or as are otherwise provided by law.

(e) The requirement to post the employee notice in paragraph (b) does not apply to—

(1) Contractors and subcontractors that employ fewer than 15 persons;

(2) Contractor establishments or construction work sites where no union has been formally recognized by the Contractor or certified as the exclusive bargaining representative of the Contractor’s employees;

(3) Contractor establishments or construction work sites located in a jurisdiction named in the definition of the United States in which the law of that jurisdiction forbids enforcement of union-security agreements;

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

27


(4) Contractor facilities where upon the written request of the Contractor, the Department of Labor Deputy Assistant Secretary for Labor-Management Programs has waived the posting requirements with respect to any of the Contractor’s facilities if the Deputy Assistant Secretary finds that the Contractor has demonstrated that—

(i) The facility is in all respects separate and distinct from activities of the Contractor related to the performance of a contract; and

(ii) Such a waiver will not interfere with or impede the effectuation of the Executive order; or

(5) Work outside the United States that does not involve the recruitment or employment of workers within the United States.

(f) The Department of Labor publishes the official employee notice in two variations; one for contractors covered by the Railway Labor Act and a second for all other contractors. The Contractor shall—

(1) Obtain the required employee notice poster from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue, NW, Room N-5605, Washington, DC 2021, or from any field office of the Department’s Office of Labor-Management Standards or Office of Federal Contract Compliance Programs;

(2) Download a copy of the poster from the Office of Labor-Management Standards website at http://www.olms.dol.gov ; or

(3) Reproduce and use exact duplicate copies of the Department of Labor’s official poster.

(g) The Contractor shall include the substance of this clause in every subcontract or purchase order that exceeds the simplified acquisition threshold, entered into in connection with this contract, unless exempted by the Department of Labor Deputy Assistant Secretary for Labor-Management Programs on account of special circumstances in the national interest under authority of 29 CFR 470.3(c). For indefinite quantity subcontracts, the Contractor shall include the substance of this clause if the value of orders in any calendar year of the subcontract is expected to exceed the simplified acquisition threshold. Pursuant to 29 CFR part 470, Subpart B - Compliance Evaluations, Complaint Investigations and Enforcement Procedures, the Secretary of Labor may direct the Contractor to take such action in the enforcement of these regulations, including the imposition of sanctions for noncompliance with respect to any such subcontract or purchase order. If the Contractor becomes involved in litigation with a subcontractor or vendor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the Secretary of Labor, to enter into such litigation to protect the interests of the United States.

(End of Clause)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

28


PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

 

1. Statement of Work

Statement of Work, dated June 24, 2010, 32 pages

 

2. Invoice/Financing Request Instructions for BARDA Cost-Reimbursement Type Contracts,

Invoice/Financing Request Instructions for BARDA Cost-Reimbursement Type Contracts, 4 pages.

 

3. Financial Report of Individual Project/Contract, 1 page

 

4. Instructions for Completing Financial Report of Individual Project/Contract, 3 pages

 

5. Report of Government Owned, Contractor Held Property (Not Attached)

Report of Government Owned, Contractor Held Property, dated 3/2008, 1 page. Located at: http://rcb.cancer.gov/rcb-internet/forms/Govt-Owned-Prop.pdf

Sections C - J of the contract

Attachment 1, Statement of Work, dated June 24, 2010

Attachment 2, Invoice/Financing Request Instructions for BARDA Cost-Reimbursement Type Contracts

Attachment 3, Financial Report of Individual Project/Contract

Attachment 4, Instructions for Completing Financial Report of Individual Project/Contract

Attachment 5, Report of Government Owned, Contractor Held Property, dated 3/2008

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

29


PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

 

1. Annual Representations and Certifications completed and located at the Online Representations and Certifications Application (ORCA) website.

 

2. Representations & Certifications dated January 12, 2010

 

3. Animal Welfare Assurance Number: LBERI - A3083-01

END of the SCHEDULE

(CONTRACT)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

30


Attachment 1

Statement of Work for the Development of rPA using P f enex Expression Technology

[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

31


ATTACHMENT 2

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

INSTRUCTIONS FOR BARDA COST-REIMBURSEMENT CONTRACTS

Format : Payment requests shall be submitted on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.

Number of Copies : Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

Frequency : Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Officer.

Cost Incurrence Period : Costs incurred must be within the contract performance period or covered by precontract cost provisions.

Billing of Costs Incurred : If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs.

Contractor’s Fiscal Year : Payment requests shall be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.

Currency : All BARDA contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

Costs Requiring Prior Approval : Costs requiring the Contracting Officer’s approval, which are not set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request.

Invoice/Financing Request Identification : Each payment request shall be identified as either:

 

(a) Interim Invoice/Contract Financing Request : These are interim payment requests submitted during the contract performance period.

 

(b) Completion Invoice : The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.

 

(c) Final Invoice : A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).

Preparation and Itemization of the Invoice/Financing Request : The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.

 

(a) Designated Billing Office Name and Address : Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(b)

Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number : Show the Contractor’s name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


  Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).

 

(c) Invoice/Financing Request Number : Insert the appropriate serial number of the payment request.

 

(d) Date Invoice/Financing Request Prepared : Insert the date the payment request is prepared.

 

(e) Contract Number and Order Number (if applicable) : Insert the contract number and order number (if applicable).

 

(f) Effective Date : Insert the effective date of the contract or if billing under an order, the effective date of the order.

 

(g) Total Estimated Cost of Contract/Order : Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.

 

(h) Total Fixed-Fee : Insert the total fixed-fee (where applicable). For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.

 

(i) Two-Way/Three-Way Match : Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(j) Office of Acquisitions : Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(k) Central Point of Distribution : Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(I) Billing Period : Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

 

(m) Amount Billed - Current Period : Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(n) Amount Billed - Cumulative : Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(o) Direct Costs : Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

 

  (1) Direct Labor : Include salaries and wages paid (or accrued) for direct performance of the contract.

For Level of Effort contracts only, the Contractor shall provide the following information on a separate sheet of paper attached to the payment request:

 

    hours or percentage of effort and cost by labor category (as specified in the Level of Effort Article in Section F of the contract) for the current billing period, and

 

    hours or percentage of effort and cost by labor category from contract inception through the current billing period. (NOTE: The Contracting Officer may require the Contractor to provide additional breakdown for direct labor, such as position title, employee name, and salary or hourly rate.)

 

  (2) Fringe Benefits : List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.

 

  (3) Accountable Personal Property : Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property ). Show permanent research equipment separate from general purpose equipment.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. An asterisk (*) shall precede the item if the equipment is below the $1,000 approval level. Include reference to the following (as applicable):

 

    item number for the specific piece of equipment listed in the Property Schedule, and

 

    COA number, if the equipment is not covered by the Property Schedule.

The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract.

 

  (4) Materials and Supplies : Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.

 

  (5) Premium Pay : List remuneration in excess of the basic hourly rate.

 

  (6) Consultant Fee : List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.

 

  (7) Travel : Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

 

  (8) Subcontract Costs : List subcontractor(s) by name and amount billed.

 

  (9) Other : List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.

 

(p) Cost of Money (COM) : Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed.

 

(q) Indirect Costs : Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.

 

(r) Fixed-Fee : Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.

 

(s) Total Amounts Claimed : Insert the total amounts claimed for the current and cumulative periods.

 

(t) Adjustments : Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.

 

(u) Grand Totals

 

(v) Certification of Salary Rate Limitation : If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:

“I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.”

The Contracting Officer may require the Contractor to submit detailed support for costs claimed on one or more interim payment requests.

FINANCIAL REPORTING INSTRUCTIONS:

These instructions are keyed to the Columns on the sample invoice/financing request.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

3


Column A - Expenditure Category : Enter the expenditure categories required by the contract.

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated : Enter the percentage of effort or number of hours agreed to for each employee or labor category listed in Column A.

Column C - Cumulative Percentage of Effort/Hrs. - Actual : Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.

Column D - Amount Billed - Current : Enter amounts billed during the current period. Column E - Amount Billed - Cumulative: Enter the cumulative amounts to date.

Column F - Cost at Completion : Enter data only when the Contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates are essential.

Column G - Contract Amount : Enter the costs agreed to for all expenditure categories listed in Column A.

Column H - Variance (Over or Under) : Show the difference between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made in Column F. This column need not be filled in when Column F is blank. When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column F by Column G, an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications : Any modification in the amount negotiated for an item since the preceding report should be listed in the appropriate cost category.

Expenditures Not Negotiated : An expenditure for an item for which no amount was negotiated (e.g., at the discretion of the Contractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in, except for G. Column H will of course show a 100 percent variance and will be explained along with those identified under H above.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

4


SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

(a)    Designated Billing Office Name and Address:

 

DHHS/OS/ASPR/BARDA

Attn: Contracting Officer

330 Independence Ave., S.W.

Room G644

Washington, D.C. 20201

 

(b)    Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:

 

ABC CORPORATION

100 Main Street

Anywhere, USA Zip Code

 

Name, Title, Phone Number, and E-mail Address of person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent.

 

VIN:

DUNS or DUNS+4:

  

(c)    Invoice/Financing Request No.:

 

(d)    Date Invoice Prepared:

 

(e)    Contract No. and Order No. (if applicable):                     

 

(f)     Effective Date:

 

(g)    Total Estimated Cost of Contract/Order:

 

(h)    Total Fixed-Fee (if applicable):

 

(i)      ¨ Two-Way Match:

 

          ¨ Three-Way Match:

 

(j)     Office of Acquisitions:

 

(k)    Central Point of Distribution:

(l)     This invoice/financing request represents reimbursable costs for the period from              to             

 

     Cumulative Percentage of
Effort/Hrs.
   Amount Billed    Cost at
Completion
F
   Contract
Amount
G
   Variance
H

Expenditure Category* A

   Negotiated
B
   Actual
C
   (m)
Current
D
   (n)
Cumulative
E
        

(o) Direct Costs:

                    

(1) Direct Labor

                    

(2) Fringe Benefits

                    

(3) Accountable Property

                    

(4) Materials & Supplies

                    

(5) Premium Pay

                    

(6) Consultant Fees

                    

(7) Travel

                    

(8) Subcontracts

                    

(9) Other

                    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

Total Direct Costs

                    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

(p) Cost of Money

                    

(q) Indirect Costs

                    

(r) Fixed Fee

                    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

(s) Total Amount Claimed

                    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

(t) Adjustments

                    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

(u) Grand Totals

                    
  

 

  

 

  

 

  

 

  

 

  

 

  

 

I certify that all payments are for appropriate purposes and in accordance with the contract.

 

 

 

   

 

 
  (Name of Official)     (Title)  

 

* Attach details as specified in the contract

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5


ATTACHMENT 3

 

FINANCIAL REPORT OF INDIVIDUAL

PROJECT/CONTRACT

 

Note: Complete this Form in Accordance with Accompanying Instructions.

  Project Task:   Contract No.:   Date of Report:  

0990-0134

0990-0131

  Reporting Period:   Contractor Name and Address:    

 

Expenditure Category

  

 

Percentage of
Effort/Hours

   Cumulative
Incurred Cost
at End of
Prior
Period
   Incurred
Cost-
Current
Period
   Cumulative
Cost to Date
(D + E)
   Estimated
Cost to
Complete
   Estimated
Cost at
Completion
(F + G)
   Negotiated
Contract
Amount
   Variance
(Over
or Under)

(I-H)
   Negotiated    Actual                     

A

  

B

  

C

  

D

  

E

  

F

  

G

  

H

  

I

  

J

                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          
                          

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


ATTACHMENT 4

INSTRUCTIONS FOR COMPLETING

“FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT”

GENERAL INFORMATION

Purpose . This Quarterly Financial Report is designed to: (1) provide a management tool for use by be BARDA in monitoring le application of financial and personnel resources to the BARDA contracts; (2) provide contractors with financial and personnel management data which is usable in their management processes; (3) promptly indicate potential areas of contract underruns or overruns by making possible comparisons of actual performance and projections with prior estimates on individual elements of cost and personnel; and (4) obtain contractor’s analyses of cause and effect of significant variations between actual and prior estimates of financial and personnel performance.

REPORTING REQUIREMENTS

Scope . The specific cost and personnel elements to be reported shall be established by mutual agreement prior to award The Government may require the contractor to provide detailed documentation to support any element(s) on one or more financial reports.

Number of Copies and Mailing Address . An original and two (2) copies of the report(s) shall be sent to the contracting officer at the address shown on the face page of the contract, no later than 30 working days after the end of the period reported. However, the contract may provide for one of the copies to be sent directly to the Contracting Officer’s Technical Representative.

REPORTING STATISTICS

A modification which extends the period of performance of an existing contract will not require reporting on a separate quarterly report, except where it is determined by the contracting officer that separate reporting is necessary. Furthermore, when incrementally funded contracts are involved, each separate allotment is not considered a separate contract entity (only a funding action). Therefore, the statistics under incrementally funded contracts should be reported cumulatively from the inception of the contract through completion.

Definitions and Instructions for Completing the Quarterly Report . For the purpose of establishing expenditure categories Column A, the following definitions and instructions will be utilized. Each contract will specify the categories to be reported.

 

(1) Key Personnel. Include key personnel regardless of annual salary rates. All such individuals should be listed by names and job titles on a separate line including those whose salary is not directly charged to the contract but whose effort is directly associated with the contract. The listing must be kept up to date.

 

(2) Personnel—Other. List as one amount unless otherwise required by the contract.

 

(3) Fringe Benefits. Include allowances and services provided by the contractor to employees as compensation in addition to regular salaries and wages. If a fringe benefit rate(s) has been established, identify the base, rate, and amount billed for each category. If a rate has not been established, the various fringe benefit costs may be required to be shown separately. Fringe benefits which are included in the indirect cost rate should not be shown here.

 

(4) Accountable Personal Property. Include nonexpendable personal property with an acquisition cost of $1,000 or more and with an expected useful life of two or more years, and sensitive items regardless of cost. Form HHS 565, “Report of Accountable Property,” must accompany the contractor’s public voucher (SF 1034/SF 1035) or this report if not previously submitted. See “Contractor’s Guide for Control of Government Property.”

 

(5) Supplies. Include the cost of supplies and material and equipment charged directly to the contract, but excludes the cost of nonexpendable equipment as defined in (4) above.

 

(6) Inpatient Care. Include costs associated with a subject while occupying a bed in a patient care setting. It normally includes both routine and ancillary costs.

 

(7) Outpatient Care. Include costs associated with a subject while not occupying a bed. It normally includes ancillary costs only.

 

(8) Travel. Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses. Travel for staff and consultants shall be shown separately. Identify foreign and domestic travel separately. If required by the contract, the following information shall be submitted: (i) Name of traveler and purpose of trip; (ii) Place of departure, destination and return, including time and dates; and (iii) total cost of trip.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

1


ATTACHMENT 4

 

(9) Consultant Fee. Include fees paid to consultant(s). Identify each consultant with effort expended, billing rate, and amount billed.

 

(10) Premium Pay. Include the amount of salaries and wages over and above the basic rate of pay. 1) Subcontracts. List each subcontract by name and amount billed.

 

(12) Other Costs. Include any expenditure categories for which the Government does not require individual line item reporting. It may include some of the above categories.

 

(13) Overhead/Indirect Costs. Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.

 

(14) General and Administrative Expense. Cite the rate and the base. In the case of nonprofit organizations, this item will usually be included in the indirect cost.

 

(15) Fee. Cite the fee earned, if any.

 

(16) Total Costs to the Government .

PREPARATION INSTRUCTIONS

These instructions are keyed to the Columns on the Quarterly Report.

Column A—Expenditure Category . Enter the expenditure categories required by the contract.

Column B—Percentage of Effort/Hours Negotiated . Enter the percentage of effort or number of hours agreed to during contract negotiations for each labor category listed in Column A.

Column C—Percentage of Effort/Hours-Actual . Enter the cumulative percentage of effort or number of hours worked by each employee or group of employees listed in Column A.

Column D—Cumulative Incurred Cost at End of Prior Period . Enter the cumulative incurred costs up to the end of the prior reporting period. This column will be blank at the time of the submission of the initial report.

Column E—Incurred Cost-Current Period . Enter the costs which were incurred during the current period. Column F—Cumulative Incurred Cost to Date. Enter the combined total of Columns D and E.

Column G—Estimated Cost to Complete . Make entries only when the contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates are essential.

Column H—Estimated Costs at Completion . Complete only if an entry is made in Column G.

Column I—Negotiated Contract Amount . Enter in this column the costs agreed to during contract negotiations for all expenditure categories listed in Column A.

Column J—Variance (Over or Under) . Complete only if an entry is made in Column H. When entries have been made in Column H, this column should show the difference between the estimated costs at completion (Column H) and negotiated costs (Column I). When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column J by Column I, an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications. List any modification in the amount negotiated for an item since the preceding report in the appropriate cost category.

Expenditures Not Negotiated . List any expenditure for an item for which no amount was negotiated (e.g., at the discretion of the contractor in performance of its contract) in the appropriate cost category and complete all columns except for I. llumn J will of course show a 100 percent variance and will be explained along with those identified under J above.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2


AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

  1 CONTRACT ID CODE  

PAGE OF PAGES

1            |             35

2 AMENDMENT/MODIFICATION NO

 

0007

 

3 EFFECTIVE DATE

 

See Block 16C

  4 REQUISITION/PURCHASE REQ NO   5 Project No ( if applicable)
6 ISSUED BY                                 CODE   HHS/OS/ASPR/BARDA       7 ADMINISTERED BY  (If other than item 6)  CODE      ASPR-BARDA02

 

HHS/OS/ASPR/BARDA

330 Independence Ave., S.W.

Room 640-G

Washington DC 20201

 

     

 

ASPR - BARDA

330 Independence Ave, SW, Rm G640

Washington DC 20201

 

8 NAME AND ADDRESS OF CONTRACTOR (No, street, county, State and ZIP Code)

 

FENEX BIOPHARMACEUTICALS, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

5501 OBERLINE DR

SAN DIEGO CA 921211718

 

 

X  

  9A AMENDMENT OF SOLICITATION NO
         

9B DATED (SEE ITEM 11)

 

    X    

10A MODIFICATION OF CNTRACT/ORDER NO

HHS0100201000045C

 

CODE             1358378   FACILITY CODE        

10B DATED ( SEE ITEM 13)

 

07/30/2010

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

¨    

 

The above numbered solicitation is amended as set forth in Item 14. The hour and  date specified for receipt of Offers     ¨  is extended     ¨  is not extended

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing Items 8 and 15, and returning                      copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted, or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12   ACCOUNTING AND APPROPRIATION DATA ( if required)
See Schedule
13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
 
CHECK ONE   A.   THIS CHANGE ORDER IS ISSUED PURSUANT TO ( Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO IN ITEM 10A
 
    B.   THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43 103(b)
 
    C.   THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF
 
    D.   OTHER ( Specify type of modification and authority)
 
    Mutual agreement of parties (FAR 43.103(a) (3) )
E. IMPORTANT:                     Contractor                              x is not                             ¨   is required to sign this document and return 0 copies to the issuing office

14 DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible)

 

Tax ID Number:        27-1356759

DUNS Number:        013603710

 

The purpose of this modification is to:

 

1. Extend Option 1 (CLIN 00002) for a term of 4/15/12 - 10/31/13;

 

2. Update SOW;

 

3. Administrative update to COA requirement;

 

4. Update Key Personnel; and

 

5. Update Transfer of Government Property.

 

Continued …

 

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed. remains unchanged end in full force and effect

15A NAME AND TITLE OF SIGNER (Type or print)

 

Charles H. Squires, V.P. Discovery

 

16A NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

MATTHEW A. MCCORD

15b CONTRACTOR/OFFEROR

 

  15C DATE SIGNED   16b UNITED STATES OF AMERICA   16c DATE SIGNED
/s/ Charles H. Squires                           4/24/13   /s/ Matthew A. McCord                               4/25/13

 

        

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53 243

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONTINUATION SHEET      

REFERENCE NO. OF DOCUMENT BEING CONTINUED

 

HHS0100201000045C/0007

 

PAGE

2

     

OF

35

NAME OF OFFEROR OR CONTRACTOR

FENEX BIOPHARMACEUTICALS, INC. 1358378

                   

ITEM NO.

(A)

 

SUPPLIES/SERVICES

(B)

 

QUANTITY    

(C)    

 

UNIT

(D)

 

UNIT PRICE    

(E)    

 

AMOUNT

(F)

   

Period of Performance: 07/30/2010 to 04/30/2013

 

 

 

 

 

 

 

                       
NSN 7540-01-152-8067         OPTIONAL FORM 336 (4-86)
        Sponsored by GSA
        FAR (48 CFR) 53/110

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


SUMMARY OF CHANGES

Beginning with the effective date of this modification, the below portions of the contract between the Government and Contractor now reads:

 

  1) Mutual Agreement to Revise Statement of Work within the Scope of the Contract

UNDER SECTION J — LIST OF ATTACHMENTS, 1. STATEMENT OF WORK will be changed as follows:

1. Statement of Work

Statement of Work, Dated April 23, 2013 (27 Pages).

 

  2) No Cost Extension

Period of performance dates for the option periods are adjusted in the contract and now reads as follows:

 

a. UNDER SECTION B— SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.3 INVOICE OPTION PRICES, shall be changed to the following:

 

CLIN

   Option Period   

Supplies/Services

   Quantity    Cost      Fixed
Fee
     Estimated  
0002    04/15/2012 -

10/31/2013

  

[*]

   1 Job      [*]         [*]         [*]   
0003    01/1/2013 -
12/31/2013
  

[*]

   1 Job      [*]         [*]         [*]   

 

b. UNDER SECTION F — DELIVERIES OR PERFORMANCE, ARTICLE F.1 PERIOD OF PERFORMANCE, shall be changed to the following:

a. The base period of performance of this contract shall be from July 30, 2010 through October 31, 2013.

b. If the Government exercises its options pursuant to the OPTION CLAUSE Article in Section H of the contract. The period of performance will be increased as defined in SECTION B of this contract.

 

  3) Update to Requirements for Pre-Authorization of Contracting Officer

UNDER SECTION B— SUPPLIES OR SERVICES AND PRICES/COSTS ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


a. Items Unallowable Unless Otherwise Provided:

[…]

7. Subcontracts:

Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

 

    is of the cost-reimbursement type*;

 

    is Fixed-Price and exceeds $150,000.

 

* Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Article.

[…]

 

  4) Update to Key Personnel

UNDER SECTION G — CONTRACT ADMINISTRATION DATA, ARTICLE G.3 KEY PERSONNEL, shall be changed to the following:

 

Name

  

Title

Carrie Schneider, Ph. D.    Principal Investigator
Chuck Squires, Ph. D.    Deputy Principal Investigator

 

  5) Transfer of Accountability of Government Property

ARTICLE G.9 TRANSFER OF ACCOUNTABILITY OF GOVERNMENT PROPERTY, shall be added to SECTION G — CONTRACT ADMINISTRATION DATA, as follows:

ARTICLE G.9. TRANSFER OF ACCOUNTABILITY OF GOVERNMENT PROPERTY

 

  a. Accountability of government property listed in this Article is hereby transferred in full from this contract (i.e. Contract No. HHS0100201000045C) to contract number HHSN272201200033C and contract number HHSN2722010000221.

The listing of property, vendor name, and date of transfer are detailed as follows:

 

  1. Government Property transferred: 1 gram rPA of Lot 563-264
    Date of Transfer: March 2013
    Contractor / U.S. Govt. Contract Number : Glide (NIAID Contract #: HHSN272201200033C)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


  2. Government Property transferred: 1 mL at 10 mg/mL of Lot EP563-317
    Date of Transfer: September 2012
    Contractor / U.S. Govt. Contract Number: Immunovaccine (NIAID Contract #: HH5N2722010000221)

 

  b. Pursuant to FAR 45.106, Transferring Accountability, an equivalent contract modification was made will be executed for the contracts controlling the gaining office’s activities. The property detailed in this Article shall now be considered Government-furnished property under Contract Number HS0100201000045C, with title vesting to the Department of Health & Human Services.

 

  c. This property is subject to the requirements of FAR 52.245-1, GOVERNMENT PROPERTY, in addition to the requirements set forth in this contract in ARTICLE G.7. GOVERNMMENT PROPERTY.

 

  d. This transfer does not affect the total obligated dollar amount to this contract. The total contract dollar amount of this contract is unchanged.

(End of Summary of Changes)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Attachment 1

[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 10.25

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[*].”

 

LOGO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


CONTRACT TABLE OF CONTENTS

 

PART I - THE SCHEDULE

     5   

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

     5   

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

     5   

ARTICLE B.2. ESTIMATED COST - OPTION

     5   

ARTICLE B.3. ADVANCE UNDERSTANDINGS

     6   

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

     8   

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

     11   

ARTICLE C.1. STATEMENT OF WORK

     11   

ARTICLE C.2. REPORTING REQUIREMENTS

     11   

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

     16   

SECTION D - PACKAGING, MARKING AND SHIPPING

     17   

SECTION E - INSPECTION AND ACCEPTANCE

     18   

SECTION F - DELIVERIES OR PERFORMANCE

     19   

ARTICLE F.1. PERIOD OF PERFORMANCE

     19   

ARTICLE F.2. DELIVERIES

     19   

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

     24   

SECTION G - CONTRACT ADMINISTRATION DATA

     25   

ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

     25   

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

     25   

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

     26   

ARTICLE G.4. INDIRECT COST RATES

     27   

ARTICLE G.5. GOVERNMENT PROPERTY

     27   

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

     28   

SECTION H - SPECIAL CONTRACT REQUIREMENTS

     29   

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

     29   

ARTICLE H.2. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

     29   

ARTICLE H.3. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV

     30   

ARTICLE H.4. HUMAN MATERIALS

     30   

ARTICLE H.5. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

     30   

ARTICLE H.6. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene Transfer Research)

     31   

ARTICLE H.7. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

     31   

ARTICLE H.8. NEEDLE DISTRIBUTION

     32   

ARTICLE H.9. ACKNOWLEDGEMENT OF FEDERAL FUNDING

     32   

ARTICLE H.10. RESTRICTION ON ABORTIONS

     32   

ARTICLE H.11. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

     32   

ARTICLE H.12. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

     32   

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-2-


ARTICLE H.13. ARTICLE H.13. PRIVACY ACT, HHSAR 352.224-70 (January 2006)

     32   

ARTICLE H.14. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

     33   

ARTICLE H.15. ANIMAL WELFARE

     33   

ARTICLE H.16. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

     34   

ARTICLE H.17. OMB CLEARANCE

     34   

ARTICLE H.18. OPTION PROVISION

     34   

ARTICLE H.19. INFORMATION AND PHYSICAL ACCESS SECURITY

     34   

ARTICLE H.20. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010)

     41   

ARTICLE H.21. CONFIDENTIALITY OF INFORMATION

     41   

ARTICLE H.22. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

     42   

ARTICLE H.23. PUBLICATION AND PUBLICITY

     44   

ARTICLE H.24. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

     44   

ARTICLE H.25. YEAR 2000 COMPLIANCE

     45   

ARTICLE H.26. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

     45   

ARTICLE H.27. SHARING RESEARCH DATA

     45   

ARTICLE H.28. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

     46   

ARTICLE H.29. HIGHLY PATHOGENIC AGENTS

     47   

ARTICLE H.30. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

     47   

ARTICLE H.31. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

     47   

ARTICLE H.32. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

     47   

ARTICLE H.33. USE OF FUNDS FOR PROMOTIONAL ITEMS

     48   

PART II - CONTRACT CLAUSES

     49   

SECTION I - CONTRACT CLAUSES

     49   

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT

     49   

ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

     52   

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

     52   

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

     54   

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

     56   

SECTION J - LIST OF ATTACHMENTS

     56   

1.   Statement of Work

     56   

2.   Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4

     56   

3.   Inclusion Table

     56   

4.   Privacy Act System of Records, Number Privacy Act System of Records, Number 09-25-0200

     56   

5.   Safety and Health

     56   

6.   Research Patient Care Costs

     56   

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-3-


7.   Disclosure of Lobbying Activities, SF-LLL

     56   

8.   Roster of Employees Requiring Suitability Investigations

     56   

9.   Employee Separation Checklist

     56   

PART IV - REPRESENTATIONS AND INSTRUCTIONS

     57   

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

     57   

1.   Annual Representations and Certifications

     57   

2.   Human Subjects Assurance Identification Number

     57   

3.   Animal Welfare Assurance Number

     57   

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-4-


PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This contract will support the advanced development of candidate vaccine components and technologies that accelerate the immune response for use in post-event settings following the intentional release of the NIAID Category A Priority Pathogen Bacillus anthracis or in response to naturally occurring outbreaks of infectious diseases caused by NIAID Category A Priority Pathogen B. anthracis.

ARTICLE B.2. ESTIMATED COST - OPTION

 

  a. The estimated cost of the Base Period of this contract is $[*].

 

  b. The fixed fee for the Base Period of this contract is $[*]. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

 

  c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $2,180,144.

 

  d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government’s total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:
     Estimated Cost
($)
  Fixed Fee
($)
 

Estimated Cost Plus

Fixed Fee
($)

Base Period (exercised)

   [*]   [*]   $2,180,144

Option Period 1

   [*]   [*]   [*]

Option Period 2

   [*]   [*]   [*]

Option Period 3

   [*]   [*]   [*]

Option Period 4

   [*]   [*]   [*]

Option Period 5

   [*]   [*]   [*]

Option Period 6

   [*]   [*]   [*]

Option Period 7

   [*]   [*]   [*]

Option Period 8

   [*]   [*]   [*]

Option Period 9

   [*]   [*]   [*]

Option Period 10

   [*]   [*]   [*]

Option Period 11

   [*]   [*]   [*]

Option Period 12

   [*]   [*]   [*]

Option Period 13

   [*]   [*]   [*]

Total (Base Period and Options)

   [*]   [*]   [*]

 

  e. [*]

 

  f. [*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-5-


ARTICLE B.3. ADVANCE UNDERSTANDINGS

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

 

  a. Subcontract

 

  1. To negotiate subcontract agreement with Althea Technologies for an amount not to exceed as follows:

 

    Option 3: $[*]

 

    Option 5: $[*]

 

    Option 7: $[*]

 

    Option 13: $[*]

Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

 

  2. To negotiate subcontract agreement with Cato Research Ltd. for an amount not to exceed as follows:

 

    Option 3: $[*]

 

    Option 5: $[*]

 

    Option 7: $[*]

 

    Option 8: $[*]

 

    Option 9: $[*]

 

    Option 10: $[*]

 

    Option 11: $[*]

 

    Option 12: $[*]

 

    Option 13: $[*]

Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

 

  3. To negotiate subcontract agreement with Glide Pharmaceutical Technologies Limited for an amount not to exceed as follows:

 

    Base Period: $[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-6-


    Option 1: $[*]

 

    Option 3: $[*]

 

    Option 4: $[*]

 

    Option 5: $[*]

Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

 

  4. To negotiate subcontract agreement with Lovelace Biomedical and Environmental Research Institute for an amount not to exceed as follows:

 

    Option 2: $[*]

 

    Option 6: $[*]

 

    Option 7: $[*]

 

    Option 9: $[*]

 

    Option 10: $[*]

 

    Option 11: $[*]

Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

 

  5. To negotiate subcontract agreement with Quintiles Inc for an amount not to exceed as follows:

 

    Option 13: $[*]

Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

 

  b. Contract Number Designation

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the two contract numbers that appear on the face page of the contract as follows:

Contract No. HHSN272201200033C

 

  c. Advance Copies of Press Releases

The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. In accordance with NIH Manual Chapter 1754, misrepresenting contract results or releasing information that is injurious to the integrity of NIH may be construed as improper conduct.

 

[*] Certain information in this document 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 complete text of NIH Manual Chapter 1754 can be found at: http://www1.od.nih.gov/oma/manualchapters/management/1754/

Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer’s Representative (COR) has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release.

 

  d. Indirect Costs

 

  1. The Contractor may bill indirect costs at temporary billing rates as follows:

Fringe Benefits = [*]% of Direct Labor

Overhead = [*]% of Total Direct Costs

These temporary rates may be utilized until such time as indirect cost rates have been established, provided, that the Contractor’s indirect cost proposal is submitted to the cognizant office responsible for negotiating indirect costs no later than three (3) months after the effective date of this contract. If the indirect cost proposal is not submitted by that time, any temporary indirect costs billed after this due date will be suspended until such time as the indirect cost proposal is submitted.

 

  2. The final amount reimbursable for indirect costs shall not exceed the following rates. Once indirect costs rates have been established, these ceilings may be renegotiated between the Contractor and the Contracting Officer and the ceilings lifted:

Fringe Benefits: [*]%

Overhead: [*]%

The Government is not obligated to pay any additional amount should the negotiated indirect cost rates exceed these ceiling rates. In the event that the negotiated indirect cost rates are less than these ceiling rates, the Government’s obligation shall be reduced to conform to the lower rate.

Any costs over and above this costs ceiling shall not be reimbursed under any other Government contract, grant, or cooperative agreement. The Contractor shall complete all work in accordance with the Statement of Work, terms and conditions of this contract.

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

 

  a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

 

  1. Conferences and Meetings

 

  2. Food for Meals, Light Refreshments, and Beverages

 

  3. Promotional Items [includes, but is not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees .]

 

  4. Acquisition, by purchase or lease, of any interest in real property;

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-8-


  5. Special rearrangement or alteration of facilities;

 

  6. Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

 

  7. Travel to attend general scientific meetings;

 

  8. Foreign travel;

 

  9. Consultant costs;

 

  10. Subcontracts;

 

  11. Patient care costs;

 

  12. Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more and “sensitive items” (defined as items of personal property (supplies and equipment that are highly desirable and easily converted to person use), regardless of acquisition value.

 

  b. Travel Costs

 

  1. Domestic Travel

Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed the following amounts for the base period and any option (if exercised) without the prior written approval of the Contracting Officer:

 

    Base Period: $[*]

 

    Option 1: $[*]

 

    Option 2: $[*]

 

    Option 3: $[*]

 

    Option 4: $[*]

 

    Option 5: $[*]

 

    Option 6: $[*]

 

    Option 7: $[*]

 

    Option 8: $[*]

 

    Option 9: $[*]

 

    Option 10: $[*]

 

    Option 11: $[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-9-


    Option 12: $[*]

 

    Option 13: $[*]

 

  2. The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.2 - Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-10-


SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

 

  a. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, dated September 24, 2012, set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.

 

  b. Privacy Act System of Records Number 09-25-0200 is applicable to this contract and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer’s Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under “Helpful Resources.”

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

 

  a. Technical Reports

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES Article in SECTION F of this contract:

[ Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research .]

 

  1. Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The first report shall be due October 15, 2012. Thereafter, reports shall be due on or before the 15th Calendar day following each reporting period.

 

  2. Annual Progress Report

This report shall include a summation of the results of the entire contract work for the period covered. An annual report will not be required for the period when the Final Report is due. A Monthly Report shall not be submitted when an Annual Report is due.

 

[*] Certain information in this document 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 first report shall cover the period September 27, 2012 through September 26, 2013 of this contract and shall be due on/before 30 days after the Anniversary Date of the Contract.

The Annual Progress Report shall describe the results of work accomplished during the reporting period in relation to the overall approved Product Development Plan, and each key objective and milestone. Each task section should include a summary paragraph of accomplishments and technical issues/problems encountered for the reporting period. Annual Progress Reports shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved, preliminary conclusions resulting from analysis, and scientific evaluation of data accumulated to date under the project for each milestone. In addition, requests and approvals to conduct human trials, and Inclusion Enrollment Report forms, when appropriate, shall be included. The current status of each task level shall be displayed on an updated Gantt chart as a component of the Annual Progress Report. Also included shall be a current task linked budget.

 

  3. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, “Inclusion Enrollment Report,” which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract. In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

Include a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender and race/ethnicity.

 

  4. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. A Monthly and an Annual report will not be required for the period when the Final Report is due.

The Contractor shall provide the Contracting Officer with one electronic copy of the Final Report in draft form (in accordance with the DELIVERIES Article in SECTION F of this contract 30 Calendar days prior to the expiration date of this contract.) The Contracting Officer’s Representative (COR) will review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified in the above paragraph.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-12-


  5. Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

 

  6. Report on Select Agents or Toxins and/or Highly Pathogenic Agents

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent , the following information shall also be included in each Annual Progress Report:

 

  1. Any changes in the use of the Select Agent or Toxin including initiation of “restricted experiments,” and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

 

  2. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

 

  a. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

 

  b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html ) or listed on the U.S. National Select Agents Registry restricted experiments website ( http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html );

 

  c. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

 

  d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Annual Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report.

 

[*] Certain information in this document 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. Other Reports/Deliverables

 

  1. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

 

  a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

  b. IT Security Plan (IT-SP)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty (30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

  c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-14-


  d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.

 

  e. IT Security Certification and Accreditation (IT-SC&A)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

  f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer’s Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

 

  a. New Employees who have or will have access to HHS Information systems or data : Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

 

  b. Departing Employees : 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the “Employee Separation Checklist”, attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

  g. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed “Commitment to Protect Non-Public Information - Contractor Agreement” form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/docs/public/Nondisclosure.pdf .

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-15-


  2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/od under “Vendor Information and Documents.”

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases

DEA, Office of Acquisitions

6700B Rockledge Dr., Room 3214

Bethesda, Maryland 20892-7612

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed “Interagency Edison,” an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

 

[*] Certain information in this document 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 D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

 

[*] Certain information in this document 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 E - INSPECTION AND ACCEPTANCE

 

  a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

 

  b. For the purpose of this SECTION, The Contracting Officer’s Representative is the authorized representative of the Contracting Officer.

 

  c. Inspection and acceptance will be performed at:

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Division of Microbiology and Infectious Diseases

6610 Rockledge Drive, MSC 6603

Bethesda, Maryland 20892-6603

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

 

  d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-3, Inspection of Supplies - Cost-Reimbursement (May 2001).

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

 

[*] Certain information in this document 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 F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

 

  a. The period of performance of this contract shall be from September 27, 2012 through November 30, 2013.

 

  b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

 

Option    Option Period
Option 1    7 Months beginning with the effective date of the Option
Option 2    9 Months beginning with the effective date of the Option
Option 3    13 Months beginning with the effective date of the Option
Option 4    11 Months beginning with the effective date of the Option
Option 5    9 Months beginning with the effective date of the Option
Option 6    12 Months beginning with the effective date of the Option
Option 7    12 Months beginning with the effective date of the Option
Option 8    12 Months beginning with the effective date of the Option
Option 9    12 Months beginning with the effective date of the Option
Option 10    12 Months beginning with the effective date of the Option
Option 11    12 Months beginning with the effective date of the Option
Option 12    12 Months beginning with the effective date of the Option
Option 13    12 Months beginning with the effective date of the Option

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

 

  a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

 

Item    Description    Quantity    Delivery Schedule
(1)    Monthly Progress Report   

1 hard copy to COR

1 electronic copy to COR and CO

   The first report is due on/ before October 15, 2012. Thereafter, each report is due on/before the 15th of the month following each reporting period. Monthly Progress Reports are not required when an Annual Progress Report or Final Report is due.

 

[*] Certain information in this document 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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Item    Description    Quantity    Delivery Schedule
(2)    Annual Technical Progress Report for Clinical Research Study Populations   

1 hard copy to COR 1 hard copy to NIAID Regulatory Affairs Designee

1 electronic copy to COR, CO, and NIAID Regulatory Affairs Designee

   Each report is due on/ before the 30th of the month following each anniversary date of the contract.
(3)    DRAFT Final Report   

1 hard copy to COR

1 electronic copy to COR and CO

   A Draft Final Report shall be provided approximately 30 calendar days before the conclusion of each option period and shall cover all Milestones within that option. The option Periods are defined in the Additional options and related tasks table. COR’s comments are due to the Contractor within 15 calendars days after receipt.
(4)    Final Report and
Summary of Salient Results
  

1 hard copy to COR

1 electronic copy to COR and CO

   A Final Report shall be provided on/before the completion date of the conclusion of each option period and shall cover all tasks within that option. The option periods are defined in the Additional options and related tasks table.

 

  b. Other Reports and Deliverables (Delivery Schedule)

 

  Item        Deliverables    Recipient    Delivery Schedule
1.    Product Development Plan    1 electronic copy to COR and CO   

The initial plan is due 30 calendar days following the effective date of the contract.

 

Updated plans annually on/before the 30 th of the month following each anniversary date of the contract or as required by the COR prior to the initiation of major product development activities or as necessary in support of contract modifications.

2.    Clinical and Regulatory Development Plan    1 electronic copy to COR, CO, and NIAID Regulatory Affairs Designee    A Clinical and Regulatory Development Plan shall be provided within 30 calendar days of contract award and modified as needed during the term of the contract based on data and regulatory meetings.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-20-


  Item        Deliverables    Recipient    Delivery Schedule
3.    Quality Systems Agreements    1 electronic copy to COR    Within 30 calendar days of the effective date of contract/ subcontract award and prior to initiation of any major product development activities.
4.    All Assay Development, Qualification and    1 electronic copy to COR    Draft plans or protocols, as appropriate, 21 days prior to implementation. Draft reports within 60 days after
     Validation Plans, Protocols, and Reports         completion of laboratory phase. Final reports within 7 days after incorporation of NIAID comments and release by QA.
5.    Draft and Final Batch Records for each production process    1 electronic copy to COR    Draft records 21 days prior to implementation. Final records within 7 days of release by QA.
6.    Certificates of Analysis for non cGMP and cGMP products    1 electronic copy to COR    Within 7 days of release by QA.
7.    Stability Reports for non cGMP and cGMP product    1 electronic copy to COR    In accordance with FDA and ICH guidelines.
8.    Shipping Validation Reports    1 electronic copy to COR    For shipment of cGMP, Clinical materials and Critical Reagents.
9.    Animal, and other non clinical study designs, protocols and reports:    1 electronic copy to COR and NIAID Regulatory Affairs Designee   

Draft study designs and protocols for approval prior to ordering animals. Draft Protocols at least 21 days prior to protocol initiation.

 

Final protocols 7 days prior to protocol initiation.

 

Draft Unaudited Reports within 6 weeks of termination of the last animal on protocol, 12 weeks if full histopathology is required.

 

Final reports within 7 days of incorporation of NIAID comments and release by QA.

10.    Chemistry, Manufacturing and Controls (CMC) information    1 electronic copy to COR and NIAID Regulatory Affairs Designee    At least 21 days prior to submission to FDA.
11.    Raw data and/or specific analyses of data generated by this contract    1 electronic copy to COR and NIAID Regulatory Affairs Designee    Within 30 calendar days of the request.
12.    Internal Audit Reports: As needed to evaluate compliance with FDA required cGMP, GLP and GCP standards    1 electronic copy to COR, CO, and NIAID Regulatory Affairs Designee    Within 30 calendar days of each audit.
13.    Audits by FDA involving contractor or subcontractor materials, facilities or operations related to this contract    1 electronic copy to COR, CO, and NIAID Regulatory Affairs Designee    Notification within 7 calendar days of each audit. Reports within 7 calendar days of receipt of each audit from the FDA.

 

[*] Certain information in this document 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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  Item        Deliverables    Recipient    Delivery Schedule
14.    FDA Pre IND Meeting Materials and Minutes    1 electronic copy to COR and NIAID Regulatory Affairs Designee   

-Pre IND Meeting materials. Within 14 calendar days prior to submission to FDA.

 

-Pre IND Meeting Minutes. Within 7 calendar days after each meeting.

15.    Clinical Trial Protocols, Amendments, and Supporting Documents (draft, revisions and final)    1 electronic copy to COR and NIAID Regulatory Affairs Designee    In accordance with to timelines or specified by DMID clinical operation guidelines.
16.    FDA IND Submissions and Meeting Minutes    1 electronic copy to COR and NIAID Regulatory Affairs Designee   

-IND materials: At least 21 calendar days prior to submission to FDA.

 

-IND Meeting minutes: Within 7 calendar days after each meeting.

17.    SAE Reports    1 electronic copy to COR and NIAID Regulatory Affairs designee    In accordance with to timelines or specified by DMID clinical operation guidelines.
18.    FDA Correspondence and Meeting Summaries    1 electronic copy to COR and NIAID Regulatory Affairs designee   

-Within 5 business days after receipt from the FDA.

 

-For correspondence to the FDA, within 5 business days prior to submission.

 

-Meeting Minutes: Within 5 business days after each meeting.

19.    Draft and Final Clinical Study Reports    1 electronic copy to COR and NIAID Regulatory Affairs designee    Prior to regulatory submission to the FDA and as requested or as available
20.    Other clinical reports (for example, IND annual reports, NIH Clinical Population Reports, SMC Reports, Clinical Trial Monitoring Plan, Data Management Plan, Safety Oversight Plan, Quality Management Plan, and Clinical Monitoring Reports)    1 electronic copy to COR    Submit according to timelines or specified by NIAID-DMID clinical operation guidelines.
21.    Contract Initiation Meeting, Annual Contract Review Meetings, and Additional Contract Meetings, Reports and Minutes.    1 electronic copy to COR and CO    Within 21 calendar days of each meeting.

 

[*] Certain information in this document 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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  Item        Deliverables    Recipient    Delivery Schedule
22.    Publications and Presentations    1 electronic to COR   

-For manuscripts, within 30 calendar days in advance of submission.

 

-For abstracts and oral presentations, within 10 calendar days in advance of submission.

23.    Annual Utilization Report    1 electronic to CO    Due on/before the 30th of the month following the anniversary date of the contract.
24.    Final Invention Statement    1 electronic to CO    Due on/before completion date of the contract.
25.    All reports and Documentation including the invention disclosure report, the confirmatory license, and the government support certification    1 electronic to OPERA    As required by FAR Clause 52.227-11.
26.    All deliverables noted on the SOW    1 electronic to COR and CO    Upon completion of each task.

 

  c. Copies of the Reports shall be sent to the following addresses:
Recipient    Address
NIAID Contract Officer Representative (COR)   

Patrick Sanz, Ph.D.

Vaccines and other Biological Products Development Section Office of Biodefense Research Affairs (OBRA)

DMID/NIAID/NIH

6610 Rockledge Drive, Room 3716

Bethesda, MD 20892

Tel: 301-402-2148

Fax: 301-480-1263

sanzp@niaid.nih.gov

 

NIAID Contracting Officer   

National Institutes of Health, DHHS

National Institute of Allergy and Infectious Diseases Division of Extramural Activities, OA 6700-B

Rockledge Drive, Room 3214, MSC 7612 Bethesda, MD 20892-7612

 

NIAID Office of Policy for Extramural Research Administration (OPERA)   

National Institutes of Health

Office of Policy for Extramural Research Administration (OPERA)

Extramural Inventions and Technology Resources Branch 6705 Rockledge Drive, Room 1040-A, MSC 7980 Bethesda, MD 20892-7980

 

 

[*] Certain information in this document 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 F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

 

[*] Certain information in this document 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 G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer’s Representative (COR) will represent the Government for the purpose of this contract:

Patrick Sanz, Ph.D.

Contracting Officer’s Representative

Vaccines and other Biological Products Development Section Office of Biodefense Research Affairs

(OBRA)/DMID/

NIAID/NIH/HHS

6700-B Rockledge Drive, Room 3716

Bethesda, MD 20892

The COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individuals are considered to be essential to the work being performed hereunder:

 

Name    Title
Dr. Charles H. Squires    Principal Investigator
Dr. Bert Liang    Clinician focused on pre-clinical and clinical studies
Dr. Lawrence Chew    Director Fermentation and Vaccine Development
Dr. Jeff Allen Biochemistry    Director Downstream Processing (DSP) and Analytical
Andy Hooper    Project Manager
Ron Cantwell    Project Control Manager

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-25-


ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

  a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

 

  1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer .

 

  a. The original invoice shall be submitted to the following designated billing office :

National Institutes of Health

Office of Financial Management

Commercial Accounts

2115 East Jefferson Street, Room 4B-432, MSC 8500

Bethesda, MD 20892-8500

 

  b. One copy of the invoice shall be submitted to the following approving official via e-mail at :

E-mail: NIAIDOAInvoices@niaid.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor’s name, contract number, and unique invoice number.

[ Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a “proper invoice.” ]

 

  2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

 

  a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIAID .

 

  b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAIDOA Invoices .

 

  c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number .] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-26-


  d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number .] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

 

  e. Invoice Matching Option. This contract requires a two-way match.

 

  f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

 

  g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance.

 

  b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

 

  c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

“I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract.”

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.5. GOVERNMENT PROPERTY

 

  a. In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, “HHS Contracting Guide for Contract of Government Property,” which is incorporated into this contract by reference. This document can be accessed at:

http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix Q_HHS Contracting Guide.pdf .

Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-27-


Requests for information regarding property under this contract should be directed to the following office:

Division of Personal Property Services, NIH

6011 Building, Suite 637

6011 EXECUTIVE BLVD MSC 7670 BETHESDA MD 20892-7670

(301) 496-5711

 

  b. Notwithstanding the provisions outlined in the HHS Publication, “HHS Contracting Guide for Contract of Government Property,” which is incorporated in this contract in paragraph a. above, the Contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

  a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

 

  b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-28-


SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

 

  a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

 

  b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

 

  c. If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Human Subject Assurances.

(End of clause)

ARTICLE H.2. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

The Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

http://grants.nih.gov/grants/guide/notice-files/not99-107.html

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

The Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract.

Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan.

The Data and Safety Monitoring Board shall be established and approved prior to beginning the conduct of the clinical trial.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-29-


ARTICLE H.3. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV

The Food and Drug Administration Amendments Act of 2007 (FDAAA) at:

http://frwebgate.access.gpo.gov/cgi-

bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf , Title VIII, expands the National Institutes of Health’s (NIH’s) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to specified “applicable clinical trials,” including those supported in whole or in part by NIH funds. FDAAA requires:

 

    the registration of certain “applicable clinical trials” (see Definitions at:
     http://grants.nih.gov/ClinicalTrials fdaaa/ definitions.htm ) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and
    the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.

In addition, the Contractor shall notify the Contracting Officer’s Representative (COR), with the trial registration number (NCT number), once the registration is accomplished. This notification may be included in the Technical Progress Report covering the period in which registration occurred, or as a stand alone notification.

The IND Sponsor will be determined after contract award, the “Responsible Party” for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov ( http://www.ClinicalTrials.gov ).

Additional information is available at: http://prsinfo.clinicaltrials.gov .

ARTICLE H.4. HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

ARTICLE H.5. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-30-


Provision by the Contractor to the Contracting Officer of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310).

ARTICLE H.6. RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene Transfer Research)

All research involving recombinant DNA molecules that is conducted at or sponsored by an entity that receives any support for recombinant DNA research from NIH shall be conducted in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) (See http://oba.od.nih.gov/rdna/ nih_guidelines_oba.html ). The NIH Guidelines stipulate biosafety and containment measures for recombinant DNA research and delineate points to consider in the development and conduct of human gene transfer clinical trials, including ethical principles and safety reporting requirements (See Appendix M of the Guidelines). More information about compliance with the NIH Guidelines can be found in a set of Frequently Asked Questions at: http://oba.od.nih.gov/rdna_ibc/ibc_faq.html .

The NIH Guidelines apply to both basic and clinical research studies. Prior to beginning any clinical trials involving the transfer of recombinant DNA to humans, the trial must be registered with the NIH OBA and reviewed by the NIH Recombinant DNA Advisory Committee (RAC). If this contract involves new protocols that contain unique and/or novel issues, the RAC may recommend that the protocol also be discussed by the RAC in a public forum. Approval of the Institutional Biosafety Committee (IBC) and the Institutional Review Board (IRB) are necessary before the Contracting Officer’s Representative (COR) and Contracting Officer may approve the protocol prior to the start of the research. The IBC approval may not occur before the NIH RAC has concluded its review of the protocol.

Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of the contract for any work related to recombinant DNA research or a requirement for Contracting Officer prior approval of any or all recombinant DNA projects under this contract. This includes the requirements of the Institutional Biosafety Committee (IBC) (See http://oba.od.nih.gov/rdna_ibc/ibc.html ).

As specified in Appendix M-1-C-4 of the NIH Guidelines , any serious adverse event that that is both unexpected and associated with the use of the gene transfer product (i.e., there is reasonable possibility that the event may have been caused by the use of the product) must be reported to the NIH OBA and IBC within 15 days, or within 7 days if the event was life-threatening or resulted in a death. A copy of the report must also be filed with the COR and Contracting Officer (See http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_M.htm ). Such reports must also be submitted within their mandated time frames to the IRB, Food and Drug Administration, and, if applicable, the HHS Office for Human Research Protections.

ARTICLE H.7. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) an electronic version of the author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov .

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-31-


Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html .

ARTICLE H.8. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

ARTICLE H.9. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.10. RESTRICTION ON ABORTIONS

The Contractor shall not use contract funds for any abortion.

ARTICLE H.11. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

ARTICLE H.12. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

ARTICLE H.13. ARTICLE H.13. PRIVACY ACT, HHSAR 352.224-70 (January 2006)

This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term “system of records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

 

[*] Certain information in this document 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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(End of clause)

45 CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html .

The Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document is also available at: http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm .

ARTICLE H.14. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

 

  a. Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

 

  b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

 

  c. The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

 

  d. If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Assurances.

 

       Note : The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov ; Web site: ( http://www.aphis.usda.gov/animal_welfare ).

(End of Clause)

ARTICLE H.15. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm

 

[*] Certain information in this document 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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In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor’s technical proposal, as modified in the Final Proposal Revision (FPR), dated 09/24/2012, which is incorporated by reference.

ARTICLE H.16. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

All Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with Nonhuman Primates,” located at the following URL:

http://oma.od.nih.gov/manualchapters/intramural/3044-2/

ARTICLE H.17. OMB CLEARANCE

In accordance with HHSAR 352.201-70, Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer’s Representative (COR) and the Contracting Officer has issued written approval to proceed.

ARTICLE H.18. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to

FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST Article in SECTION B of this contract.

ARTICLE H.19. INFORMATION AND PHYSICAL ACCESS SECURITY

 

  A. Standard for Security Configurations, HHSAR 352.239-70 , (January 2010)

 

  a. The Contractor shall configure its computers that contain HHS data with the applicable Federal Desktop Core Configuration (FDCC) (see http://nvd.nist.gov/fdcc/index.cfm ) and ensure that its computers have and maintain the latest operating system patch level and anti-virus software level.

 

       Note : FDCC is applicable to all computing systems using Windows XPTM and Windows VistaTM, including desktops and laptops - regardless of function - but not including servers.

 

  b. The Contractor shall apply approved security configurations to information technology (IT) that is used to process information on behalf of HHS. The following security configuration requirements apply: FDCC

 

  c.

The Contractor shall ensure IT applications operated on behalf of HHS are fully functional and operate correctly on systems configured in accordance with the above configuration requirements. The Contractor shall use Security Content Automation Protocol (SCAP)-validated tools with FDCC Scanner capability to ensure its products operate correctly with

 

[*] Certain information in this document 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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FDCC configurations and do not alter FDCC settings - see http://nvd.nist.gov/validation.cfm . The Contractor shall test applicable product versions with all relevant and current updates and patches installed. The Contractor shall ensure currently supported versions of information technology products met the latest FDCC major version and subsequent major versions.

 

  d. The Contractor shall ensure IT applications designed for end users run in the standard user context without requiring elevated administrative privileges.

 

  e. The Contractor shall ensure hardware and software installation, operation, maintenance, update, and patching will not alter the configuration settings or requirements specified above.

 

  f. The Contractor shall (1) include Federal Information Processing Standard (FIPS) 201-compliant (http//csrc.nist.gov/publications/fips/fips201-1/FIPS-201-1-chng1.pdf) , Homeland Security Presidential Directive 12 (HSPD-12) card readers with the purchase of servers, desktops, and laptops; and (2) comply with FAR Subpart 4.13, Personal Identity Verification.

 

  g. The Contractor shall ensure that its subcontractors (at all tiers) which perform work under this contract comply with the requirements contained in this clause.

 

  B. Security Requirements For Federal Information Technology Resources, HHSAR 352.239-72 , (January 2010)

 

  a. Applicability . This clause applies whether the entire contract or order (hereafter “contract”), or portion thereof, includes information technology resources or services in which the Contractor has physical or logical (electronic) access to, or operates a Department of Health and Human Services (HHS) system containing, information that directly supports HHS’ mission. The term “information technology (IT)”, as used in this clause, includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services) and related resources. This clause does not apply to national security systems as defined in FISMA.

 

  b. Contractor responsibilities . The Contractor is responsible for the following:

 

  1. Protecting Federal information and Federal information systems in order to ensure their -

 

  a. Integrity, which means guarding against improper information modification or destruction, and includes ensuring information non-repudiation and authenticity;

 

  b. Confidentiality, which means preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information; and

 

  c. Availability, which means ensuring timely and reliable access to and use of information.

 

  2. Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor, regardless of location, on behalf of HHS.

 

[*] Certain information in this document 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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  3. Adopting, and implementing, at a minimum, the policies, procedures, controls and standards of the HHS Information Security Program to ensure the integrity, confidentiality, and availability of Federal information and Federal information systems for which the Contractor is responsible under this contract or to which it may otherwise have access under this contract. The HHS Information Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief Information Officer’s (OCIO) Web site.

 

  c. Contractor security deliverables . In accordance with the timeframes specified, the Contractor shall prepare and submit the following security documents to the Contracting Officer for review, comment, and acceptance:

 

  1. IT Security Plan (IT-SP) - due within 30 days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor’s bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

 

  a. The Contractor’s IT-SP shall comply with applicable Federal laws that include, but are not limited to, the Federal Information Security Management Act (FISMA) of 2002 (Title III of the E-Government Act of 2002, Public Law 107-347), and the following Federal and HHS policies and procedures:

 

  i. Office of Management and Budget (OMB) Circular A-130, Management of Federal Information Resources, Appendix III, Security of Federal Automation Information Resources.

 

  ii. National Institutes of Standards and Technology (NIST) Special Publication (SP) 800-18, Guide for Developing Security Plans for Information Systems, in form and content, and with any pertinent contract Statement of Work/Performance Work Statement (SOW/ PWS) requirements. The IT-SP shall identify and document appropriate IT security controls consistent with the sensitivity of the information and the requirements of Federal Information Processing Standard (FIPS) 200, Recommend Security Controls for Federal Information Systems. The Contractor shall review and update the IT-SP in accordance with NIST SP 800-26, Security Self-Assessment Guide for Information Technology Systems and FIPS 200, on an annual basis.

 

  iii. HHS-OCIO Information Systems Security and Privacy Policy.

 

  2. IT Risk Assessment (IT-RA) - due within 30 days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy. After resolution of any comments provided by the Government on the draft IT-RA, the Contracting Officer shall accept the IT-RA and incorporate the Contractor’s final version into the contract for Contractor implementation and maintenance. The Contractor shall update the IT-RA on an annual basis.

 

[*] Certain information in this document 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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  3. FIPS 199 Standards for Security Categorization of Federal Information and Information Systems Assessment (FIPS 199 Assessment) – due within 30 days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard. After resolution of any comments by the Government on the draft FIPS 199 Assessment, the Contracting Officer shall accept the FIPS 199 Assessment and incorporate the Contractor’s final version into the contract.

 

  4. IT Security Certification and Accreditation (IT-SC&A) - due within 3 months after contract award. The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed for applicable information systems - see paragraph (a) of this clause. The Contractor shall perform the IT-SC&A in accordance with the HHS Chief Information Security Officer’s Certification and Accreditation Checklist; NIST SP 800-37, Guide for the Security, Certification and Accreditation of Federal Information Systems; and NIST 800-53, Recommended Security Controls for Federal Information Systems. An authorized senior management official shall sign the draft IT-SC&A and provided it to the Contracting Officer for review, comment, and acceptance.

 

  a. After resolution of any comments provided by the Government on the draft IT SC&A, the Contracting Officer shall accept the IT-SC&A and incorporate the Contractor’s final version into the contract as a compliance requirement.

 

  b. The Contractor shall also perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid. Evidence of a valid system accreditation includes written results of:

 

  i. Annual testing of the system contingency plan; and

 

  ii. The performance of security control testing and evaluation.

 

  d. Personal identity verification . The Contractor shall identify its employees with access to systems operated by the Contractor for HHS or connected to HHS systems and networks. The Contracting Officer’s Representative (COR) shall identify, for those identified employees, position sensitivity levels that are commensurate with the responsibilities and risks associated with their assigned positions. The Contractor shall comply with the HSPD-12 requirements contained in “HHS-Controlled Facilities and Information Systems Security” requirements specified in the SOW/PWS of this contract.

 

  e. Contractor and subcontractor employee training . The Contractor shall ensure that its employees, and those of its subcontractors, performing under this contract complete HHS-furnished initial and refresher security and privacy education and awareness training before being granted access to systems operated by the Contractor on behalf of HHS or access to HHS systems and networks. The Contractor shall provide documentation to the COR evidencing that Contractor employees have completed the required training.

 

  f. Government access for IT inspection . The Contractor shall afford the Government access to the Contractor’s and subcontractors’ facilities, installations, operations, documentation, databases, and personnel used in performance of this contract to the extent required to carry out a program of IT inspection (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the integrity, confidentiality, and availability, of HHS data or to the protection of information systems operated on behalf of HHS.

 

[*] Certain information in this document 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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  g. Subcontracts . The Contractor shall incorporate the substance of this clause in all subcontracts that require protection of Federal information and Federal information systems as described in paragraph (a) of this clause, including those subcontracts that -

 

  a. Have physical or electronic access to HHS’ computer systems, networks, or IT infrastructure; or

 

  b. Use information systems to generate, store, process, or exchange data with HHS or on behalf of HHS, regardless of whether the data resides on a HHS or the Contractor’s information system.

 

  h. Contractor employment notice . The Contractor shall immediately notify the Contracting Officer when an employee either begins or terminates employment (or is no longer assigned to the HHS project under this contract), if that employee has, or had, access to HHS information systems or data.

 

  i. Document information . The Contractor shall contact the Contracting Officer for any documents, information, or forms necessary to comply with the requirements of this clause.

 

  j. Contractor responsibilities upon physical completion of the contract . The Contractor shall return all HHS information and IT resources provided to the Contractor during contract performance and certify that all HHS information has been purged from Contractor-owned systems used in contract performance.

 

  k. Failure to comply . Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause shall be grounds for the Contracting Officer to terminate this contract.

(End of Clause)

Note : The NIST Special Publication SP-800-26 cited in subparagraph c.1.a.(ii) of this clause has been superseded by NIST SP 800-53A, “Guide for Assessing the Security Controls in Federal Information Systems and Organizations” for use for the assessment of security control effectiveness. See http://csrc.nist.gov/publications/PubsSPs.html to access NIST Special Publications (800 Series).

 

  C. Additional NIH Requirements

 

  1. SECURITY CATEGORIZATION OF FEDERAL INFORMATION AND INFORMATION SYSTEMS (FIPS 199 Assessment)

 

  a. Information Type:

 

  [  ] Administrative, Management and Support Information:

 

  [X] Mission Based Information:

 

  b. Security Categories and Levels:

 

Confidentiality Level:    [X] Low    [  ] Moderate    [  ] High
Integrity Level:    [  ] Low    [X] Moderate    [  ] High
Availability Level:    [X] Low    [  ] Moderate    [  ] High
Overall Level:    [  ] Low    [X] Moderate    [  ] High

 

[*] Certain information in this document 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. In accordance with HHSAR Clause 352.239-72, the contractor shall submit a FIPS 199 Assessment within 30 days after contract award. Any differences between the contractor’s assessment and the information contained herein, will be resolved, and if required, the contract will be modified to incorporate the final FIPS 199 Assessment.

 

  2. INFORMATION SECURITY TRAINING

In addition to any training covered under paragraph (e) of HHSAR 352.239-72, the contractor shall comply with the below training:

 

  a. Mandatory Training

 

  i. All Contractor employees having access to (1) Federal information or a Federal information system or (2) sensitive data/information as defined at HHSAR 304.1300(a) (4), shall complete the NIH Computer Security Awareness Training course at http://irtsectraining.nih.gov/ before performing any work under this contract. Thereafter, Contractor employees having access to the information identified above shall complete an annual NIH-specified refresher course during the life of this contract. The Contractor shall also ensure subcontractor compliance with this training requirement.

 

  ii. The Contractor shall maintain a listing by name and title of each Contractor/Subcontractor employee working on this contract and having access of the kind in paragraph 1.a(1) above, who has completed the NIH required training. Any additional security training completed by the Contractor/Subcontractor staff shall be included on this listing. The list shall be provided to the COR and/or Contracting Officer upon request.

 

  b. Role-based Training

HHS requires role-based training when responsibilities associated with a given role or position, could, upon execution, have the potential to adversely impact the security posture of one or more HHS systems. Read further guidance at Secure One HHS Memorandum on Role-Based Training Requirement .

For additional information see the following: http://ocio.nih.gov/security/security-communicating.htm#RoleBased .

The Contractor shall maintain a list of all information security training completed by each contractor/subcontractor employee working under this contract. The list shall be provided to the COR and/or Contracting Officer upon request.

 

  c. Rules of Behavior

The Contractor shall ensure that all employees, including subcontractor employees, comply with the NIH Information Technology General Rules of Behavior ( http://ocio.nih.gov/security/nihitrob.html ), which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov .

 

  3. PERSONNEL SECURITY RESPONSIBILITIES

In addition to any personnel security responsibilities covered under HHSAR 352.239-72, the contractor shall comply with the below personnel security responsibilities:

 

[*] Certain information in this document 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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  a. In accordance with Paragraph (h) of HHSAR 352.239-72, the Contractor shall notify the Contracting officer and the COR within five working days before a new employee assumes a position that requires access to HHS information systems or data, or when an employee with such access stops working on this contract. The Government will initiate a background investigation on new employees assuming a position that requires access to HHS information systems or data, and will stop pending background investigations for employees that no longer work under the contract or no longer have such access.

 

  b. New contractor employees who have or will have access to HHS information systems or data: The Contractor shall provide the COR with the name, position title, e-mail address, and phone number of all new contract employees working under the contract and provide the name, position title and position sensitivity level held by the former incumbent. If an employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate position sensitivity level.

 

  c. Departing contractor employees : The Contractor shall provide the COR with the name, position title, and position sensitivity level held by or pending for departing employees. The Contractor shall perform and document the actions identified in the Contractor Employee Separation Checklist ( http://ocio.nih.gov/nihsecurity/Emp-sep-checklist.pdf ) when a Contractor/ subcontractor employee terminates work under this contract. All documentation shall be made available to the COR upon request.

 

  d. Commitment to Protect Non-Public Departmental Information and Data .

 

     The Contractor, and any subcontractors performing under this contract, shall not release, publish, or disclose non-public Departmental information to unauthorized personnel, and shall protect such information in accordance with provisions of the following laws and any other pertinent laws and regulations governing the confidentiality of such information:

 

  18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)
  18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)
  Public Law 96-511 (Paperwork Reduction Act)

 

     Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the “Commitment to Protect Non-Public Information - Contractor Employee Agreement” located at: http://ocio.nih.gov/docs/public/Nondisclosure.pdf .
     A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

 

  4. LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION (PII) - NOTIFICATION OF DATA BREACH

 

     The Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT) via email ( IRT@mail.nih.gov ) within one hour of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of the applicable two forms below within three (3) work days of incident discovery:

 

           NIH PII Spillage Report at: http://ocio.nih.gov/docs/public/PII Spillage Report.doc
           NIH Lost or Stolen Assets Report at: http://ocio.nih.gov/docs/public/Lost or Stolen.doc

 

[*] Certain information in this document 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 H.20. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010)

 

  a. Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order must comply with the “Electronic and Information Technology Accessibility Provisions” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 provisions is available at http://www.section508.gov/ . The complete text of Section 508 Final provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm .

 

  b. The Section 508 standards applicable to this contract/order are identified in the Statement of Work. The contractor must provide a written Section 508 conformance certification due at the end of each contract/ order exceeding $100,000 when the contract/order duration is one year or less. If it is determined by the Government that EIT products and services provided by the Contractor do not conform to the described accessibility standards in the Product Assessment Template, remediation of the products or services to the level of conformance specified in the Contractor’s Product Assessment Template will be the responsibility of the Contractor at its own expense.

 

  c. In the event of a modification(s) to this contract/order, which adds new EIT products or services or revises the type of, or specifications for, products or services the Contractor is to provide, including EIT deliverables such as electronic documents and reports, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template to assist the Government in determining that the EIT products or services support Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS Office on Disability Web site ( http://www.hhs.gov/od/ ).

 

     [(End of HHSAR 352.239-73(b)]

 

  d. Prior to the Contracting Officer exercising an option for a subsequent performance period/additional quantity or adding funding for a subsequent performance period under this contract, as applicable, the Contractor must provide a Section 508 Annual Report to the Contracting Officer and Project Officer. Unless otherwise directed by the Contracting Officer in writing, the Contractor shall provide the cited report in accordance with the following schedule. Instructions for completing the report are available in the Section 508 policy on the HHS Office on Disability Web site under the heading Vendor Information and Documents. The Contractor’s failure to submit a timely and properly completed report may jeopardize the Contracting Officer’s exercising an option or adding funding, as applicable.

Schedule for Contractor Submission of Section 508 Annual Report:

[End of HHSAR 352.239-73(c)]

ARTICLE H.21. CONFIDENTIALITY OF INFORMATION

 

  a. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

 

[*] Certain information in this document 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 Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the “Disputes” clause.

 

  c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

 

  d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

 

  e. Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

 

  f. Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

 

  g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

ARTICLE H.22. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

The Institution (includes any contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under NIH contracts, or proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&rgn=div5&view=text&node=45:1.0.1.1.52&idno=45

As required by 45 CFR Part 94, the Institution shall, at a minimum:

 

  a. Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator’s reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:

 

  1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;

 

[*] Certain information in this document 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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  2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest; or

 

  3. Intellectual property rights and interests, upon receipt of income related to such rights and interest.

Significant financial interests do not include the following:

 

  1. Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and

 

  2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

 

  b. Require each Investigator to complete training regarding the Institution’s financial conflicts of interest policy prior to engaging in research related to any NIH-funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.

 

  c. Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the NIH-funded research.

 

  d. Require that each Investigator who is planning to participate in the NIH-funded research disclose to the Institution’s designated official(s) the Investigator’s significant financial interest (and those of the Investigator’s spouse and dependent children) no later than the date of submission of the Institution’s proposal for NIH-funded research. Require that each Investigator who is participating in the NIH-funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.

 

  e. Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator’s significant financial interest is related to NIH-funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator’s significant financial interest is related to NIH-funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the NIH-funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research.

 

  f. Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).

 

  g. Provide initial and ongoing FCIO reports to the Contracting Officer pursuant to Part 94.5(b).

 

  h. Maintain records relating to all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures, and all actions under the Institution’s policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

 

[*] Certain information in this document 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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  i. Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.

 

  j. Complete the certification in Section K - Representations, Certifications, and Other Statements of Offerors titled “Certification of Institutional Policy on Financial Conflicts of Interest”.

If the failure of an Institution to comply with an Institution’s financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the NIH-funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the NIH-funded research project.

The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Institution’s review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution’s determination of a financial conflict of interests. The Contracting Officer may require submission of the records or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer may decide that a particular financial conflict of interest will bias the objectivity of the NIH-funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

If the Contracting Officer determines that NIH-funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was managed or reported by the Institution, the shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

ARTICLE H.23. PUBLICATION AND PUBLICITY

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

“This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201200033C”

ARTICLE H.24. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477) . All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-44-


ARTICLE H.25. YEAR 2000 COMPLIANCE

In accordance with FAR 39.106, Information Technology acquired under this contract must be Year 2000 compliant as set forth in the following clause(s):

 

  1. Service Involving the Use of Information Technology
     YEAR 2000 COMPLIANCE--SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY

The Contractor agrees that each item of hardware, software, and firmware used under this contract shall be able to accurately process date data (including, but not limited to, calculating, comparing and sequencing) from, into and between the twentieth and twenty-first centuries and the Year 1999 and the Year 2000 and leap year calculations.

(End of Clause)

ARTICLE H.26. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

Unique research resources arising from NIH-funded research are to be shared with the scientific research community. NIH provides guidance, entitled, “Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice,” (Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate terms for disseminating and acquiring these research resources. This guidance, found at: http://ott.od.nih.gov/pdfs/64FR72090.pdf is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

Note: For the purposes of this Article, the terms, “research tools”, “research materials”, and “research resources” are used interchangeably and have the same meaning.

 

  a. Sharing of Model Organisms for Biomedical Research

The plan for sharing model organisms submitted by the Contractor is acceptable. The Contractor agrees to adhere to its plan and shall request prior approval of the Contracting Officer for any changes in its plan.

ARTICLE H.27. SHARING RESEARCH DATA

The data sharing plan submitted by the Contractor is acceptable. The Contractor agrees to adhere to its plan and shall request prior approval of the Contracting Officer for any changes in its plan.

The NIH endorses the sharing of final research data to serve health. this contract is expected to generate research data that must be shared with the public and other researchers. NIH’s data sharing policy may be found at the following Web site:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/ ). The rights and privacy of people who participate in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-45-


ARTICLE H.28. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

The work being conducted under this contract may involve the possession, use, or transfer of a select agent or toxin. The contractor shall not conduct work involving a Select Agent or Toxin under this contract until it and any associated subcontractor(s) comply with the following:

For prime or subcontract awards to domestic institutions that possess, use, and/or transfer a Select Agent or Toxin under this contract, the institution must comply with the provisions of 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 ( http://www.selectagents.gov/Regulations.html ) as required, before using NIH funds for work involving a Select Agent or Toxin. No NIH funds can be used for research involving a Select Agent or Toxin at a domestic institution without a valid registration certificate.

For prime or subcontract awards to foreign institutions that possess, use, and/or transfer a Select Agent or Toxin, before using NIH funds for any work directly involving a Select Agent or Toxin, the foreign institution must provide information satisfactory to the NIAID that safety, security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be administered on behalf of all Select Agent or Toxin work supported by these funds. The process for making this determination includes a site visit to the foreign laboratory facility by an NIAID representative. During this visit, the foreign institution must provide the following information: concise summaries of safety, security, and training plans; names of individuals at the foreign institution who will have access to the Select Agent or Toxin and procedures for ensuring that only approved and appropriate individuals, in accordance with institution procedures, will have access to the Select Agents or Toxins under the contract; and copies of or links to any applicable laws, regulations, policies, and procedures applicable to that institution for the safe and secure possession, use, and/ or transfer of select agents. Site visits to foreign laboratories are conducted every three years after the initial review. No NIH funds can be used for work involving a Select Agent or Toxin at a foreign institution without written approval from the Contracting Officer.

Prior to conducting a restricted experiment with a Select Agent or Toxin under this contract or any associated subcontract, the contractor must discuss the experiment with the Contracting Officer’s Representative (COR) and request and obtain written approval from the Contracting Officer. Domestic institutions must submit to the Contracting Officer written approval from the CDC to perform the proposed restricted experiment. Foreign institutions require review by a NIAID representative. The prime contractor must contact the COR and the NIAID Office of International Extramural Activities (OIEA) at mailto:niaidforeignawards@niaid.nih.gov for guidance on the process used by NIAID to review proposed restricted experiments. The NIAID website provides an overview of the review process at http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/saconproc.aspx . The Contracting Officer will notify the prime contractor when the process is complete. No NIH funds can be used for a restricted experiment with a Select Agent or Toxin at either a domestic or foreign institution without written approval from the Contracting Officer.

Listings of HHS and USDA select agents and toxins, and overlap select agents or toxins as well as information about the registration process for domestic institutions, are available on the Select Agent Program Web site at http://www.selectagents.gov/ and http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html .

For foreign institutions, see the NIAID Select Agent Award information:

( http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/default.aspx ).

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-46-


ARTICLE H.29. HIGHLY PATHOGENIC AGENTS

The work being conducted under this contract may involve a Highly Pathogenic Agent (HPA) . The NIAID defines an HPA as a pathogen that, under any circumstances, warrants a biocontainment safety level of BSL3 or higher according to either:

 

  1. The current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) (http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm) ;

 

  2. The Contractor’s Institutional Biosafety Committee (IBC) or equivalent body; or

 

  3. The Contractor’s appropriate designated institutional biosafety official.

If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an IBC or equivalent body, or institutional biosafety official, the highest recommended containment level must be used.

ARTICLE H.30. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting, convention, conference or training seminar that is conducted in, or that otherwise uses the rooms, facilities, or services of a place of public accommodation that do not meet the requirements of the fire prevention and control guidelines as described in the Public Law. This restriction applies to public accommodations both foreign and domestic.

Public accommodations that meet the requirements can be accessed at: http://www.usfa.fema.gov/hotel/index.htm .

ARTICLE H.31. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

ARTICLE H.32. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

The Contractor shall not use contract funds to conduct meetings or conferences without prior written Contracting Officer approval.

In addition, the use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-47-


The following conferences and/or meetings have been approved by the Contracting Officer and are hereby authorized under this contract:

 

Conference or

Meeting Title

  

Conference or

Meeting Location

   Federal/
NonFederal Space
  

Date of

Conference

  

Not to Exceed

Estimate Cost

         

[    ] Federal

[    ] NonFederal

         
         

[    ] Federal

[    ] NonFederal

         
         

[    ] Federal

[    ] NonFederal

         
         

[    ] Federal

[    ] NonFederal

         

ARTICLE H.33. USE OF FUNDS FOR PROMOTIONAL ITEMS

The Contractor shall not use contract funds to purchase promotional items. Promotional items include, but are not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees. This includes items or tokens given to individuals as these are considered personal gifts for which contract funds may not be expended.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-48-


PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at: https://www.acquisition.gov/far/ . HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html .

 

  a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

FAR
CLAUSE NO.      

 

  

DATE

 

    

TITLE

 

52.202-1

 

  

Jan 2012

 

    

Definitions (Over the Simplified Acquisition Threshold)

 

52.203-3

 

   Apr 1984      Gratuities (Over the Simplified Acquisition Threshold)

52.203-5

 

   Apr 1984      Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)
52.203-6    Sep 2006     

Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)

 

52.203-7    Oct 2010     

Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)

 

52.203-8    Jan 1997     

Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

 

52.203-10    Jan 1997     

Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

 

52.203-12    Oct 2010     

Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)

 

52.204-4    May 2011     

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (Over the Simplified Acquisition Threshold)

 

52.204-7    Aug 2012     

Central Contractor Registration

 

52.204-10    Aug 2012     

Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)

 

52.209-6    Dec 2010     

Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)

 

52.215-2    Oct 2010     

Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]

 

52.215-8    Oct 1997     

Order of Precedence - Uniform Contract Format

 

52.215-10    Aug 2011     

Price Reduction for Defective Certified Cost or Pricing Data (Over $700,000)

 

52.215-12    Oct 2010     

Subcontractor Cost or Pricing Data (Over $700,000)

 

52.215-14    Oct 2010     

Integrity of Unit Prices (Over the Simplified Acquisition Threshold)

 

52.215-15    Oct 2010      Pension Adjustments and Asset Reversions (Over $700,000)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-49-


FAR
CLAUSE NO.      

 

  

DATE

 

    

TITLE

 

52.215-18    Jul 2005     

Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

 

52.215-19    Oct 1997     

Notification of Ownership Changes

 

52.215-21    Oct 2010     

Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications

 

52.215-23    Oct 2009     

Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)

 

52.216-7    Jun 2011     

Allowable Cost and Payment

 

52.216-8    Jun 2011     

Fixed Fee

 

52.219-8    Jan 2011     

Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold)

 

52.219-9    Jan 2011     

Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)

 

52.219-16    Jan 1999     

Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction)

 

52.222-2    Jul 1990     

Payment for Overtime Premium (Over the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)

 

52.222-3    Jun 2003     

Convict Labor

 

52.222-21    Feb 1999     

Prohibition of Segregated Facilities

 

52.222-26    Mar 2007     

Equal Opportunity

 

52.222-35    Sep 2010     

Equal Opportunity for Veterans ($100,000 or more)

 

52.222-36    Oct 2010     

Affirmative Action for Workers with Disabilities

 

52.222-37    Sep 2010     

Employment Reports on Veterans ($100,000 or more)

 

52.222-40    Dec 2010     

Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)

 

52.222-50    Feb 2009     

Combating Trafficking in Persons

 

52.222-54    Jul 2012     

Employment Eligibility Verification (Over the Simplified Acquisition Threshold)

 

52.223-6    May 2001     

Drug-Free Workplace

 

52.223-18    Aug 2011     

Encouraging Contractor Policies to Ban Text Messaging While Driving

 

52.225-1    Feb 2009     

Buy American Act - Supplies

 

52.225-13    Jun 2008     

Restrictions on Certain Foreign Purchases

 

52.227-1    Dec 2007     

Authorization and Consent, Alternate I (Apr 1984)

 

52.227-2    Dec 2007     

Notice and Assistance Regarding Patent and Copyright Infringement

 

52.227-11    Dec 2007     

Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.

 

52.227-14    Dec 2007     

Rights in Data - General

 

52.232-9    Apr 1984     

Limitation on Withholding of Payments

 

52.232-17    Oct 2010     

Interest (Over the Simplified Acquisition Threshold)

 

52.232-20    Apr 1984     

Limitation of Cost

 

52.232-23    Jan 1986      Assignment of Claims    

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-50-


FAR
CLAUSE NO.      

 

  

DATE

 

    

TITLE

 

52.232-25    Oct 2008     

Prompt Payment, Alternate I (Feb 2002)

 

52.232-33    Oct 2003     

Payment by Electronic Funds Transfer--Central Contractor Registration

 

52.233-1    Jul 2002     

Disputes

 

52.233-3    Aug 1996     

Protest After Award, Alternate I (Jun 1985)

 

52.233-4    Oct 2004     

Applicable Law for Breach of Contract Claim

 

52.242-1    Apr 1984     

Notice of Intent to Disallow Costs

 

52.242-3    May 2001     

Penalties for Unallowable Costs (Over $700,000)

 

52.242-4    Jan 1997     

Certification of Final Indirect Costs

 

52.242-13    Jul 1995     

Bankruptcy (Over the Simplified Acquisition Threshold)

 

52.243-2    Aug 1987     

Changes - Cost Reimbursement, Alternate V (Apr 1984)

 

52.244-2    Oct 2010     

Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007)

 

52.244-5    Dec 1996     

Competition in Subcontracting (Over the Simplified Acquisition Threshold)

 

52.244-6    Dec 2010     

Subcontracts for Commercial Items

 

52.245-1    Apr 2012     

Government Property

 

52.245-9    Apr 2012     

Use and Charges

 

52.246-23    Feb 1997     

Limitation of Liability (Over the Simplified Acquisition Threshold)

 

52.249-6    May 2004     

Termination (Cost-Reimbursement)

 

52.249-14    Apr 1984     

Excusable Delays

 

52.253-1    Jan 1991      Computer Generated Forms

 

  b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

HHSAR
CLAUSE NO.      

 

  

DATE

 

    

TITLE

 

352.202-1    Jan 2006     

Definitions - with Alternate paragraph (h) (Jan 2006)

 

352.203-70    Mar 2012     

Anti-Lobbying

 

352.216-70    Jan 2006     

Additional Cost Principles

 

352.222-70    Jan 2010     

Contractor Cooperation in Equal Employment Opportunity Investigations

 

352.227-70    Jan 2006     

Publications and Publicity

 

352.228-7    Dec 1991     

Insurance - Liability to Third Persons

 

352.233-71    Jan 2006     

Litigation and Claims

 

352.242-70    Jan 2006     

Key Personnel

 

352.242-73    Jan 2006     

Withholding of Contract Payments

 

352.242-74    Apr 1984      Final Decisions on Audit Findings

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 08/2012].

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-51-


ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

ARTICLE I.1. of this SECTION is hereby modified as follows:

 

  a. Alternate I , (December 1991), of FAR Clause 52.233-1, Disputes (December 1998) is added.

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

 

  a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

  1. FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (April 2010).

 

  2. FAR Clause 52.203-14, Display of Hotline Poster(s) (December 2007).

“....(3) Any required posters may be obtained as follows:

 

   

Poster(s)

 

  

Obtain From”

 

    
 

 

HHS Contractor Code of Ethics and

Business Conduct Poster

 

  

 

     http://oig.hhs.gov/fraud/report-         

     fraud/OIG_Hotline_Poster.pdf         

 

  

 

  3. FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

 

  4. FAR Clause 52.217-7, Option for Increased Quantity - Separately Priced Line Item (March 1989).

“....The Contracting Officer may exercise the option by written notice to the Contractor within 60 days before the contract expires or prior to the exercise of the options.”

 

  5. FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (January 2011).

“(c) Waiver of evaluation preference.....

[  ] Offeror elects to waive the evaluation preference.”

 

  6. FAR Clause 52.219-28, Post-Award Small Business Program Rerepresentation (April 2012).

 

  7. FAR Clause 52.224-1, Privacy Act Notification (April 1984).

 

  8. FAR Clause 52.224-2, Privacy Act (April 1984).

 

  9. Alternate II (December 2007), FAR Clause 52.227-14, Rights in Data--General (December 2007).

Additional purposes for which the limited rights data may be used are:

(i) Use (except for manufacture) by support service contractors.

(ii) Evaluation by nongovernment evaluators.

(iii) Use (except for manufacture) by other contractors participating in the Government’s program of which the specific contract is a part.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-52-


  10. Alternate V (December 2007), FAR Clause 52.227-14, Rights in Data--General (December 2007).

 

  11. FAR Clause 52.227-16, Additional Data Requirements (June 1987).

 

  12. FAR Clause 52.227-17, Rights in Data--Special Works (December 2007).

 

  13. FAR Clause 52.230-2, Cost Accounting Standards (May 2012).

 

  14. FAR Clause 52.230-6, Administration of Cost Accounting Standards (June 2010).

 

  15. FAR Clause 52.232-18, Availability of Funds (April 1984).

 

  16. FAR Clause 52.239-1, Privacy or Security Safeguards (August 1996).

 

  17. FAR Clause 52.247-63, Preference for U.S. Flag Air Carriers (June 2003).

 

  18. FAR Clause 52.247-68, Report of Shipment (REPSHIP) (February 2006).

 

  19. FAR Clause 52.251-1, Government Supply Sources (April 2012).

 

  b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:

 

  1. HHSAR Clause 352.201-70, Paperwork Reduction Act (January 2006).

 

  2. HHSAR Clause 352.223-70, Safety and Health (January 2006).

 

  3. HHSAR Clause 352.231-70, Salary Rate Limitation (March 2012).

Note: P.L. 112-74 sets forth the Salary Rate Limitation at the Executive Level II Rate, effective December 23, 2011.

See the following Web site for Executive Schedule rates of pay: http://www.opm.gov/oca/ .

(For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

 

  4. HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to Persons with Disabilities (January 2001).

 

  c. NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:

The following clauses are attached and made a part of this contract:

 

  1. NIH(RC)-11, Research Patient Care Costs (4/1/84).

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-53-


ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text.

 

  a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

  1. FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (February 2012)

(a) The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the Central Contractor Registration database at https://www.acquisition.gov .

(b) As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111-212), all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments--

(1) The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by--

(i) Government personnel and authorized users performing business on behalf of the Government; or

(ii) The Contractor, when viewing data on itself; and

(2) The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for--

(i) Past performance reviews required by subpart 42.15;

(ii) Information that was entered prior to April 15, 2011; or

(iii) Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

(c) The Contractor will receive notification when the Government posts new information to the Contractor’s record.

(1) If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

(2) The Contractor will also have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-54-


(3) As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available.

(d) Public requests for system information posted prior to April 15, 2011, will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

(End of clause)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-55-


PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

 

1. Statement of Work

Statement of Work, dated September 24, 2012, 13 pages.

 

2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4

Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (8/12), 6 pages.

 

3. Inclusion Table

Inclusion Table (Formerly Annual Technical Progress Report Format for Each Study), April, 1998, 1 page. Located at: http://grants.nih.gov/grants/funding/women min/InclusionOldForm.pdf

 

4. Privacy Act System of Records, Number Privacy Act System of Records, Number 09-25-0200

 

5. Safety and Health

Safety and Health, HHSAR Clause 352.223-70, (1/06), 1 page.

 

6. Research Patient Care Costs

Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.

 

7. Disclosure of Lobbying Activities, SF-LLL

Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages

 

8. Roster of Employees Requiring Suitability Investigations

Roster of Employees Requiring Suitability Investigations, 1 page. Excel file located at:

http://ocio.nih.gov/docs/public/ Suitability-roster.xls

 

9. Employee Separation Checklist

Employee Separation Checklist, 1 page. Fillable PDF format located at: http://ocio.nih.gov/nihsecurity/Emp-sep-checklist.pdf

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-56-


PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

 

  1. Annual Representations and Certifications completed and located in the Online Representations and Certifications Application (ORCA) at The System for Acquisition Management (SAM) website ( http://www.sam.gov ). [This includes the changes identified in paragraph (b) of the FAR provision 52.204-8, Annual Representations and Certifications, contained in the Contractor’s proposal.]

 

  2. Human Subjects Assurance Identification Number: FWA00004217.

Quintiles, Inc. FWA# 00003974

 

  3. Animal Welfare Assurance Number: A3083-01

END of the SCHEDULE

(CONTRACT)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

-57-


STATEMENT OF WORK

Base Period

[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4

Format : Submit payment requests on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.

Number of Copies : Submit payment requests in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

Frequency : Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Office.

Cost Incurrence Period : Costs incurred must be within the contract performance period or covered by precontract cost provisions.

Billing of Costs Incurred : If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall cite the amount(s) and month(s) in which the costs were incurred.

Contractor’s Fiscal Year : Prepare payment requests in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.

Currency : All NIH contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract shall not exceed the United States dollars authorized.

Costs Requiring Prior Approval : Identify and reference the Contracting Officer’s Authorization (COA) Number for costs requiring the Contracting Officer’s approval, which are not set forth in an Advance Understanding in the contract. In addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate entry under the appropriate expenditure category on the payment request.

Invoice/Financing Request Identification : Identify each payment as either:

 

(a) Interim Invoice/Contract Financing Request : These are interim payment requests submitted during the contract performance period.

 

(b) Completion Invoice : Submit the completion invoice promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and all performance provisions have been completed.

 

(c) Final Invoice : A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

NIH(RC)-4    
Rev. 8/2012   1   Attachment 2


Preparation and Itemization of the Invoice/Financing Request : The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request. All information must be legible or the invoice will be considered improper and returned to the Contractor.

 

(a) Designated Billing Office Name and Address : Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(b) Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4 Number : Show the Contractor’s name and address exactly as they appear in the contract. Any invoice identified as improper will be sent to this address. Also include the name, title, phone number, and email address of the Point of Contact in case of questions. If the remittance name differs from the legal business name, both names must appear on the invoice. Provide the Contractor’s Federal Taxpayer Identification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4 number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract, and as registered in the Central Contractor Registration (CCR) database.

When an approved assignment of claims has been executed, the Contractor shall provide the same information for the assignee as is required for the Contractor (i.e., name, address, point of contact, TIN, and DUNS number), with the remittance information clearly identified as such.

 

(c) Invoice/Financing Request Number : Identify each payment request by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization. For example, if a contractor has already submitted invoice number 05 on one of its contracts or orders, it cannot use that same invoice number on any other contract or order. Payment requests with duplicate invoice numbers will be considered improper and returned to the contractor.

The NIH does not prescribe a particular numbering format but suggests using a job or account number for each contract and order followed by a sequential invoice number (example: 8675309-05). Invoice numbers are limited to 30 characters. There are no restrictions on the use of special characters, such as colons, dashes, forward slashes, or parentheses.

If all or part of an invoice is suspended and the contractor chooses to reclaim those costs on a supplemental invoice, the contractor may use the same unique invoice number followed by an alpha character, such as “R” for revised (example: 8675309-05R).

 

(d) Date Invoice/Financing Request Prepared : Insert the date the payment request is prepared.

 

(e) Contract Number and Order Number (if applicable) : Insert the contract number and order number (if applicable).

 

(f) Contract Title : Insert the contract title exactly as it appears on the cover page of the contract.

 

(g) Current Contract Period of Performance : Insert the contract start date/effective date through the current completion date of the contract.

 

(h) Effective Date : Insert the effective date of the contract or if billing under an order, the effective date of the order.

 

(i) Total Estimated Cost of Contract/Order : Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For contracts/orders with options or incremental funding provisions, enter the amount currently obligated and available for payment.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

NIH(RC)-4    
Rev. 8/2012   2   Attachment 2


(j) Total Fixed-Fee : Insert the total fixed-fee (where applicable). For contracts/orders with options or incremental funding provisions, enter the amount currently obligated and available for payment (where applicable).

 

(k) Two-Way/Three-Way Match : Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(l) Office of Acquisitions : Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(m) Central Point of Distribution : Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

(n) Billing Period : Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

 

(o) Amount Billed - Current Period : Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(p) Amount Billed - Cumulative : Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

 

(q) Direct Costs : Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

 

  1) Direct Labor : Include salaries and wages paid (or accrued) for direct performance of the contract.

 

     For Level of Effort contracts only, the Contractor shall provide the following information on a separate sheet of paper attached to the payment request:

 

  - hours or percentage of effort and cost by labor category (as specified in the Level of Effort Article in Section F of the Contract Schedule) for the current billing period, and

 

  - hours or percentage of effort and cost by labor category from contract inception through the current billing period. (NOTE: The Contracting Officer may require the Contractor to provide additional breakdown for direct labor, such as position title, employee name, and salary or hourly rate.)

 

  2) Fringe Benefits : List any fringe benefits applicable to direct labor and billed as a direct cost. Cite the rate(s) used to calculate fringe benefit costs, if applicable.

 

  3) Accountable Personal Property : Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property ). Show permanent research equipment separate from general purpose equipment.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

NIH(RC)-4    
Rev. 8/2012   3   Attachment 2


On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. Precede the item with an asterisk (*) if the equipment is below the $1,000 approval level. Include reference to the following (as applicable):

 

  - item number for the specific piece of equipment listed in the Property Schedule, and Contracting Officer Authorization (COA) number, if the equipment is not covered by the Property Schedule.

The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract.

 

  4) Materials and Supplies : Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.

 

  5) Premium Pay : List remuneration in excess of the basic hourly rate.

 

  6) Consultant Fee : List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.

 

  7) Travel : Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

 

  8) Subcontract Costs : List subcontractor(s) by name and amount billed.

 

  9) Other : List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.

 

  (r) Cost of Money (COM) : Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed.

 

  (s) Indirect Costs : Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.

 

  (t) Fixed-Fee : Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.

 

  (u) Total Amounts Claimed : Insert the total amounts claimed for the current and cumulative periods.

 

  (v) Adjustments : Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.

 

  (w) Grand Totals

Certification of Salary Rate Limitation : If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:

“I certify that all payments requested are for appropriate purposes and in accordance with the contract and the salaries billed are in compliance with the Salary Rate Limitation Provisions in Section I of the contract.”

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

NIH(RC)-4    
Rev. 8/2012   4   Attachment 2


The Contracting Officer may require the Contractor to submit detailed support for costs claimed on one or more interim payment requests.

FINANCIAL REPORTING INSTRUCTIONS:

These instructions are keyed to the Columns on the sample invoice/financing request.

Column A - Expenditure Category : Enter the expenditure categories required by the contract.

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated : Enter the percentage of effort or number of hours agreed to for each employee or labor category listed in Column A.

Column C - Cumulative Percentage of Effort/Hrs. - Actual : Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.

Column D - Amount Billed - Current : Enter amounts billed during the current period.

Column E - Amount Billed - Cumulative : Enter the cumulative amounts to date.

Column F - Cost at Completion : Enter data only when the Contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates are essential.

Column G - Contract Amount : Enter the costs agreed to for all expenditure categories listed in Column A.

Column H - Variance (Over or Under) : Show the difference between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made in Column F. This column need not be filled in when Column F is blank. When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column F by Column G, an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications : List all new modification(s) (not previously reported) in the amount negotiated for an item in the appropriate cost category.

Expenditures Not Negotiated : An expenditure for an item for which no amount was negotiated (e.g., at the discretion of the Contractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in, except for G. Column H will of course show a 100 percent variance and will be explained along with those identified under H above.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

NIH(RC)-4    
Rev. 8/2012   5   Attachment 2


 

LOGO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


INCLUSION TABLE

This report format should NOT be used for data collection from study participants.

 

Principal Investigator/Project Director

    

(Last, First, Middle)

  

 

Grant Number (if known) :

    

 

STUDY TITLE :

    

 

Total Enrollment:                                                                                                    Protocol Number:                                                                                         
      

American
Indian or
Alaskan
Native

 

  

Asian or
Pacific
Islander

 

  

Black, not

of Hispanic
Origin

 

  

Hispanic

 

  

White, not

of Hispanic
Origin

 

  

Other or
Unknown

 

  

Total

 

         

Female

 

                                  
         

Male

 

                                  
         

Unknown

 

                                  
         

Total

 

                                  

Attachment 3

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


ATTACHMENT 4 – PRIVACY ACT SYSTEM OF RECORDS, NUMBER

09-25-0200

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHSN272201200033C   Page 1   Attachment 4


Safety and Health, HHSAR 352.223-70 (January 2006)

 

(a) To help ensure the protection of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State, and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies at the Federal, State, and local levels.

 

  (1) In addition, the Contractor shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test projects:

 

  (ii) 29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health and safety standards issued by OSHA and included in 29 CFR Part 1910. These regulations are available at: http://www.osha.gov .

 

  (ii) Nuclear Regulatory Commission Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies from the U.S. Nuclear Regulatory Commission, Washington, DC 20555¬0001.

 

  (2) The following Government guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel and facilities:

 

  (i) Biosafety in Microbiological and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4toc.htm .

 

  (ii) Prudent Practices for Safety in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This publication is available at http://www.nap.edu/catalog/4911.html .

 

(b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer’s Technical Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting Officer will make an equitable adjustment in accordance with the applicable “Changes” clause set forth in this contract.

 

(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

 

(d)

If the Contractor fails or refuses to comply with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to the

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Safety and Health, HHSAR 352.223-70 (January 2006)   Page 1 of 2


 

Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

 

(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor is responsible for the compliance of its subcontractors with the provisions of this clause.

(End of clause)

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Safety and Health, HHSAR 352.223-70 (January 2006)   Page 2 of 2


RESEARCH PATIENT CARE COSTS -- NIH(RC)-11

 

(a) Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract.

 

(b) Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative.

 

(c) Prior to submitting an invoice for patient care costs under this contract, the contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care.

 

(d) The contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement.

 

(e) Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

NIH(RC)-11, Research Patient Care Costs   
4/1/84    Page 1 of 1


LOGO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

This disclosure form shall be completed by the reporting entity, whether subawardee of prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing of attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action. Use the SF-LLL-A Continuation Sheet for additional information if the space on the form is inadequate. Complete all items that apply for both the initial filing and material change report. Refer to the implementing guidance published by the Office of Management and Budget for additional information.

 

1.

Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

 

2.

Identify the status of the covered Federal action.

 

3.

Identify the appropriate classification of this report. If this is a follow-up report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.

 

4.

Enter the full name, address, city, state and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.

 

5.

If the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address, city, state and zip code of the prime Federal recipient. Include Congressional District, if known.

 

6.

Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For example, Department of Transportation, United States Coast Guard.

 

7.

Enter the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.

 

8.

Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number, Invitation for Bid (IFB) number, grant announcement number, the contract, grant, or loan award number, the application/proposal control number assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.”

 

9.

For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.

 

10.   (a)

Enter the full name, address, city, state and zip code of the lobbying registrant under the Lobbying Disclosure of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.

 

  (b)

Enter the full names of the individual(s) performing services, and include full address if different from 10(a); Enter Last Name, First Name, and Middle Initial (MI).

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of Lobbying Activities     ATTACHMENT 7
SF-LLL   2  


11. The certifying official shall sign and date the form, print his/her name, title and telephone number.

 

According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB 0348¬0046. Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, D.C. 20503.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Disclosure of Lobbying Activities     ATTACHMENT 7
SF-LLL   3  


DISCLOSURE OF LOBBYING ACTIVITIES

CONTINUATION SHEET

Approved by OMB

0348-0046

     Reporting Entity:                                                                                                        Page                  of                 

 

 

 

Authorized for Local Reproduction

Standard Form--LLL-A

Disclosure of Lobbying Activities             ATTACHMENT 7

SF-LLL

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHSN272201200033C   Page 1   Attachment 8


ATTACHMENT 8 – COMMITMENT TO PROTECT NON-PUBLIC INFORMATION

Located at: http://ocio.nih.gov/docs/public/Nondisclosure.pdf

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHSN272201200033C   Page 1   Attachment 9


ATTACHMENT 9– ROSTER OF EMPLOYEES REQUIRING SUITABILITY INVESTIGATIONS

Located at: http://ocio.nih.gov/docs/public/Suitability-roster.xls

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHSN272201200033C   Page 1   Attachment 9


 

LOGO

   National Institutes of Health (NIH)
Phone: 301-496-0612    National Institute of Allergy and Infectious Diseases (NIAID)
Fax: 301-402-0972    Office of Acquisitions, DEA
http://www.niaid.nih.gov/    6700B Rockledge Drive, Room 3214
   Bethesda, MD 20892-7612

April 8, 2013

Transmitted via email to:

pkl@pfenex.com        

Mr. Patrick Lucy

Pfenex, Inc.

10790 Roselle Street

San Diego, CA 92121

Subject: Contract No.: HHSN272201200033C

Modification No.: 01

Dear Mr. Lucy,

We are enclosing an executed copy of the subject modification for your retention. If you have any questions regarding the administration of this contract, please contact me at (301) 451-2569 or by email at welshmi@mail.nih.gov .

Sincerely,

/s/ Michael Welsh

Michael Welsh

Contracting Officer Representative

Microbiology and Infectious Diseases

Research Contracts Branch-B

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

LOGO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHS-556


 

Contract No:

HHSN272201200033C

 

  

 

Modification No: 01

  

 

Page 2 of 2

ARTICLE G.2. KEY PERSONNEL (HIISAR 352.242-70 (January 2006) is hereby modified to update key personnel as follows:

 

                         Name                            Title
Dr. Carrie Schneider    Principal Investigator
Dr. Chuck Squires                            Deputy Principle Investigator
Dr. Bert Liang    Clinician focused on pre-clinical and clinical studies
Dr. Jeff Allen Biochemistry    Director Downstream Processing (DSP) and Analytical Biochemistry
Lei Lei Sengchanthalangsy    Project Manager
Ron Cantwell    Project Control Manager

ARTICLE 11.32. USE OF FUNDS FOR CONFERENCES, MEETINGS, AND FOOD is hereby modified as follows:

The Contractor shall not use contract funds ( direct or indirect ) to conduct meetings or conferences without prior written Contracting Officer approval.

In addition, the use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited.

The following conferences and/or meetings have been approved by the Contracting Officer and are hereby authorized under this contract:

 

Conference or

Meeting Title

  

Conference or

Meeting Location

   Federal/
NonFederal Space
  

Date of

Conference

  

Not to Exceed

Estimate Cost

         

[  ] Federal

[  ] NonFederal

         
         

[  ] Federal

[  ] NonFederal

         
         

[  ] Federal

[  ] NonFederal

         
         

[  ] Federal

[  ] NonFederal

         

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT is hereby modified to incorporate the following FAR clause, which replaces FAR 52.204-7:

 

FAR

CLAUSE NO.

   DATE    TITLE
52.204-13                    Dec 2012                Central Contractor Registration Maintenance

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHS-556


 

LOGO

 

 

Phone: 301-496-0612

Fax: 301-402-0972

http://www.niaid.nih.gov/

  

National Institutes of Health (NIH)

National Institute of Allergy and Infectious Diseases (NIAID)

Office of Acquisitions, DEA

6700B Rockledge Drive, Room 3214

Bethesda, MD 20892-7612

November 27, 2013

Transmitted via email to:

cbrady@pfenex.com     

Cassidy Brady

Senior Manager of Marketing and Business Development

Pfenex Inc.

10790 Roselle Street

San Diego, CA 92121

Subject: Contract No.: HHSN272201200033C

Modification No.: 02

Dear Ms. Brady,

We are enclosing an executed copy of the subject modification for your retention. If you have any questions regarding the administration of this contract, please contact me at (301) 451-2569 or by email at welshmimail.nih.gov .

Sincerely,

/s/ Michael P. Welsh

Michael P. Welsh

Contracting Officer

Microbiology and Infectious Diseases

Research Contracts Branch-B

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

LOGO

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


 

Contract No:

HHSN272201200033C

 

  

 

Modification No: 02

  

 

Page 2 of 4

The period of performance listed on the face page of the contract (SF-26) in Block 15A is changed as follows: “09/27/2012 — 10/31/2014”

ARTICLE B.2. ESTIMATED COST — OPTION , the Base Period chart under paragraph f., is hereby modified as follows:

 

    Task Number        Task Description    Deliverable        Percentage                Fees        
              Base Period              
1.1.1.2   

[*]

  

Upon Completion of the task as described in the SOW

  

[*]

  

[*]

1.1.1.4   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.1.5   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.2.1   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.2.3   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.2.4   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.4.1   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.4.3   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

1.1.4.4   

[*]

   Upon Completion of the task as described in the SOW   

[*]

  

[*]

Total Base Period                  

[*]

ARTICLE C.2. REPORTING REQUIREMENTS , the first paragraph and paragraph a.2 are hereby modified as follows, respectively:

All reports required herein shall be submitted in a secure electronic format. The Contractor shall make CDs of the reports available upon the request of the Contracting Officer.

a.2. Annual Progress Report

This report shall include a summation of the results of the entire contract work for the period covered and incorporate a yearly updated assay development plan. An Annual Report will not be required in the same year when the Final Report for the entire contract is due. A Monthly Report shall not be submitted when an Annual Report is due.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHS-556


 

Contract No:

HHSN272201200033C

 

  

 

Modification No: 02

  

 

Page 3 of 4

ARTICLE F.2. DELIVERIES , paragraph b., is hereby modified to add the following sentence before the chart:

b. Other Reports and Deliverables (Delivery Schedule) — An item is considered “Delivered” when such item has been reviewed, modified as needed and accepted by NIAID.

ARTICLE G.2. KEY PERSONNEL (HHSAR 352.242-70 (January 2006) is hereby modified to update key personnel as follows:

 

                         Name                            Title
Dr. Carrie Schneider    Principal Investigator
Dr. Chuck Squires    Deputy Principle Investigator
Dr. Bert Liang    Clinician focused on pre-clinical and clinical studies
Dr. Jeff Allen Biochemistry    Director Downstream Processing (DSP) and Analytical Biochemistry
Cassidy Brady    Project Manager
Ron Cantwell    Project Control Manager

ARTICLE G.5. GOVERNMENT PROPERTY , paragraph a., is revised to change the Division name and contract information as follows:

Division of Logistic Services, NIH

Property Management Branch

6011 Building, Suite 639

6011 EXECUTIVE BLVD MSC 7670

BETHESDA MD 20892-7670

nihcontractproperty@nih.gov

ARTICLE G.7. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, 52.232-99 (DEVIATION) (August 2013) is hereby incorporated as follows:

This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012, and the extension to that policy provided by OMB Policy Memorandum M-13-15, Extension of Policy to Provide Accelerated Payment to Small Business Subcontractors, dated July 11, 2013.

  a. Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.
  b. Include the substance of this article, including this paragraph (b), in all subcontracts with small business concerns.
  c. The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHS-556


 

Contract No:

HHSN272201200033C

 

  

 

Modification No: 02

  

 

Page 4 of 4

ARTICLE H.18. OPTION PROVISION is hereby modified as follows:

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I. , the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST Article in SECTION B of this contract.

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

HHS-556


STATEMENT OF WORK

Base Period

[*]

 

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.