Exhibit 10.15

CONFIDENTIAL TREATMENT REQUESTED

 

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)  

8.   DELIVERY

 

Pfenex Biopharmaceuticals.

Incorporated 5501 Oberlin Drive

San Diego, CA 92121

 

See Schedule

 

 

9/   DISCOUNT FOR PROMPT PAYMENT

N/A

 

            10. SUBMIT INVOICES ADDRESS SHOWN IN:  

ITEM

 

See Section G

CODE DUNS No. 013603710   FACILITY CODE                     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

 

14. ACCOUNTING AND APPROPRIATION DATA

      ¨ 10 U.S.C. 2304(c)(    )  

¨ 41 U.S.C. 253(c)(    )

 

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  
FY 2010     $    10,088,986     Performance Period. July 30, 2010 through
December 12, 2011   Option 1     $      1,590,218     Contract Type: COST PLUS
FIXED FEE   Option 2     $      1,025,164     BARDA-BAA-09-100-SOL-0010   Option
3     $      4,289,230       Option 4     $      1,084,229         Option 5    
  $         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 I 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

  x   F   DELIVERIES OR PERFORMANCE   11           AND OTHER STATEMENTS OF
OFFERORS     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.

 

[***] Certain information in this 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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19A.   NAME AND TITLE OF SIGNER (Type or print)

 

20A.   NAME OF CONTRACTING OFFICER

   

  BERTRAND LIANG, MD, MBA, CEO

 

MICHAEL A. YOUNKINS AMCG, ASPR, OS, DHHS

19B.   NAME OF CONTRACTOR

    19C. DATE SIGNED    

20B.   UNITED STATES OF AMERICA

    20C.   DATE SIGNED            

/s/    Bertrand C. Liang        

    7/27/2010   BY  

/s/    Michael A. Younkins        

    7/30/2010    

(Signature of person authorized to sign)

 

             

(Signature of Contracting Officer)

 

       

NSN 7540-01-152-8069

PREVIOUS EDITION UNUSABLE

 

28-107

Computer Generated

  

STANDARD FORM 26 (REV. 4-85)

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.

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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.

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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 $[***].

 

  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    [***]   [***]   [***]

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.

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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.

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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.

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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 Pfenex 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.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities not otherwise provided by the Government as needed to perform the
Statement of Work dated 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 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

 

[***] Certain information in this 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 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

 

[***] Certain information in this 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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plan for addressing areas of nonconformance to FDA regulations and guidance for
GLP, GMP or GCP guidelines as identified in the final audit report.

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.

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(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: [*]). 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

[*]

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.

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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   
[***]    [***]    [***]

 

[***] Certain information in this 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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2002      06/03/2013-06/01/2014       Stage 3b: [***]    1 Job    [***]    [***]
   [***] 2003      06/02/2014-07/06/2015       Stage 3c: [***]    1 Job    [***]
   [***]    [***]

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    Monthly Progress Report    2 electronic   

CO: (1) electronic copy

COTR: One (1) electronic

   The 15th 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.    Quarterly Progress Report    2
electronic    Same as CO and COTR above    15th 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

 

[***] Certain information in this 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)

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)

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 3rd Street, S.W. Suite 320

Washington, DC 20201

E-mail: [*]

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.

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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:

[*]

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

[*] (Office)

[*]

Alternate COTR:

[*]

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

[*] (Office)

[*]

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.

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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: [*] Room G640   
Washington, D.C. 20201    E-mail: [*]   

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.

 

[***] Certain information in this 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. 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.

 

  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:

[*]

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.

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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.

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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)

 

[***] Certain information in this 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.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.

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.

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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:

 

[***] Certain information in this 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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Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

ARTICLE H.15. 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.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.

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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.

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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.

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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)

 

[***] Certain information in this 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 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.

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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 Act (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.

(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:

 

[***] Certain information in this 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) 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.

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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.

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(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.

-30-

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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.

-31-

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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.

-32-

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Attachment 1

Statement of Work for the Development of rPA using Pfenex 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.

-33-

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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.

 

[***] Certain information in this 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-

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(b) Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4
Number: Show the Contractor’s name and address exactly as they appear in the
contract, along with the name, title, phone number, and e-mail address of the
person to notify in the event of an improper invoice or, in the case of payment
by method other than Electronic Funds Transfer, to whom payment is to be sent.
Provide the Contractor’s Vendor Identification Number (VIN), and Data

Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must
identify the Contractor’s name and address exactly as stated on the face page of
the contract. When an approved assignment has been made by the Contractor, or a
different payee has been designated, provide the same information for the payee
as is required for the Contractor (i.e., name, address, point of contact, VIN,
and DUNS).

 

(c) Invoice/Financing Request Number: Insert the appropriate serial number of
the payment request.

 

(d) Date Invoice/Financing Request Prepared: Insert the date the payment request
is prepared.

 

(e) Contract Number and Order Number (if applicable): Insert the contract number
and order number (if applicable).

 

(f) Effective Date: Insert the effective date of the contract or if billing
under an order, the effective date of the order.

 

(g) Total Estimated Cost of Contract/Order: Insert the total estimated cost of
the contract, exclusive of fixed-fee. If billing under an order, insert the
total estimated cost of the order, exclusive of fixed-fee. For incrementally
funded contracts/orders, enter the amount currently obligated and available for
payment.

 

(h) Total Fixed-Fee: Insert the total fixed-fee (where applicable). 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

 

[***] Certain information in this 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-

--------------------------------------------------------------------------------

- 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.

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:

 

[***] Certain information in this 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-

--------------------------------------------------------------------------------

“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.

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-

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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:

 

(I)       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-

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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.

 

[***] Certain information in this 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-

--------------------------------------------------------------------------------

(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.

-2-

--------------------------------------------------------------------------------

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.

CoIumn 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.

-3-

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT   1. CONTRACT ID CODE  

PAGE OF PAGES

        1        |         4

2 AMENDMENT/MODIFICATION NO.

 

0001

     

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 OBERLIN DR

SAN DIEGO CA 921211718

  (x)     9A. AMENDMENT OF SOLICITATION NO.            

9B. DATED (SEE ITEM 11)

 

  X    

10A. MODIFICATION OF CONTRACT/ORDER NO

HHSO100201000045C

   

10B.  DATED (SEE ITEM 13)

 

7/30/2010

CODE        1358378

 

  FACILITY CODE        

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATION

 

¨ 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 ACKNOWLEDGMENT 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 APPLIES ONLY TO MODIFICATIONS 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)

 

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

Period of Performance: 07/30/2010 to 12/12/2011

This action is a modification to the original contract signed July 30, 2010. The
following sections of the original agreement are hereby modified as detailed in
the subsequent three (3) pages:

1.   The Contracting Officer of record as defined in ARTICLE G.2.

2.   Deliverables as defined in SECTION F.2.

3.   Transfer of certain Accountable Government Property to the contract, now
defined in ARTICLE G.9.

This modification does not increase the overall contract value or period of
performance of the original contract.

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A.   NAME AND TITLE OF SIGNER (Type or print)

 

Bertrand C. Liang, CEO

 

16A.   NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

GLYNIS M. FISHER

 

  15B. CONTRACTOR/OFFEROR     15C. DATE SIGNED     16B. UNITED STATES OF AMERICA
     16C. DATE SIGNED        

/s/ Bertrand C. Liang

(Signature of person authorized to sign)

         

/s/ Glynis M. Fisher

(Signature of Contracting Officer)

 

      

    10/31/2011

 

NSN 7540-01.152-8070

Previous edition unusable

  30-105   

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.

--------------------------------------------------------------------------------

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Beginning with the effective date of this modification, the contract between the
Government and Contractor now reads:

 

1) In accordance with ARTICLE G.2. CONTRACTING OFFICER, the official Contracting
Officer on record is hereby changed from [*] to [*]. Additionally, the official
Contract Specialist on record is changed from [*] to [*]. Any reference to
Contracting Officer or Contract Specialist throughout the contract is to be
updated accordingly.

[*]

Contracting Officer

[*]

[*]

[*]

Contract Specialist

[*]

[*]

 

2) Adjustment of select deliverables due dates.

UNDER SECTION F – DELIVERIES OR PERFORMANCE, ARTICLE F.2 DELIVERIES, shall be
changed to the following:

 

Item

 

Description

 

Quantity

 

Addresses

 

Delivery Schedule

Technical Progress Reports

1)   Monthly Progress Report   2 electronic  

CO: (1) electronic copy

 

COTR: One (1) electronic

  The 15th 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)   Draft Final Technical
Progress Report   2 electronic   Same as CO and COTR above   30 calendar days
before the completion date of the contract 3)   Final Technical Progress Report
  2 electronic   Same as CO and COTR above   On or before the expiration date of
the contract 4)   Summary of Salient Results   2 electronic   Same as CO and
COTR above   On or before the expiration date of the contract

Other Technical Reports

5)   Audit Reports   2 electronic   Same as CO and COTR above   Within 30
Calendar days of the audit 6)   RCB Characterization Report   2 electronic  
Same as CO and COTR above   Within 30 Calendar days of completing RCB
Characterization

 

[***] Certain information in this 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)   MCB/WCB Characterization Report   2 electronic   Same as CO and COTR above
  Within 30 Calendar days of completing MCB/WCB Characterization 8)   Stage
milestone reports (and addendums)   2 electronic   Same as CO and COTR above  
Within 30 calendar days of completing milestone (or option period)

Other Reports

9)   FDA Correspondence and Meeting Summaries   1 electronic   Same as COTR  
Within 30 calendar days of receiving correspondence or meeting with the FDA 10)
  Invention Report Annual Utilization Report   2 electronic  

1 electronic to OPERA.

 

CO: 1 electronic

  Due on or before the 30th of the month following each anniversary date of the
contract. 11)   Final Invention Report   2 electronic  

1 electronic to OPERA.

 

1 CO: 1 electronic

  Due on or before the completion date of the contract.

 

3) 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 to this contract, Contract No. HHSO100201000045C. The said
property was Government property formerly accounted for under Contact No.
HDTRA1-07-C-0084. The listing of property, their original date of purchase,
description of property, vendor name, acquisition of cost are detailed 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.

--------------------------------------------------------------------------------

2007-2008 DARPA EQUIPMENT ORDERS

 

Date Purchased

   Vendor      Item Purchased      Amount  

10/17/2007

     [*** ]       [*** ]     $ 107,211.25   

10/30/2007

     [*** ]       [*** ]     $ 178,179.50   

1/16/2008

     [*** ]       [*** ]     $ 85,557.00   

4/22/2008

     [*** ]       [*** ]     $ 235,694.11            

 

 

 

TOTAL

$ 606,641.86            

 

 

 

2008 DTRA EQUIPMENT ORDERS

 

Date Purchased

   Vendor      Item Purchased      Amount  

9/29/2008

     [*** ]       [*** ]     $ 61,875.00   

9/29/2008

     [*** ]       [*** ]     $ 61,875.00   

TOTAL

         $ 123,750.00   

2009 DTRA EQUIPMENT ORDERS

 

Date Purchased

   Vendor      Item Purchased      Amount  

12/9/2008

     [*** ]       [*** ]     $ 20,199.89   

3/26/2009

     [*** ]       [*** ]     $ 2,539.35   

4/2/2009

     [*** ]       [*** ]     $ 485,305.60   

TOTAL

         $ 508,044.84            

 

 

 

 

b. Pursuant to FAR 45.106, Transferring Accountability, an equivalent contract
modification was made to Contract No. HDTRA1-07-C-0084, executed August 17, 2011
(Modification No. A00003). The property detailed in this Article shall now be
considered Government-furnished property under Contract Number HSO100201000045C,
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. GOVERNMENT 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.

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT  

1. CONTRACT ID CODE

 

PAGE OF PAGES

1        |        4

2. AMENDMENT/MODIFICATION NO.

 

0002

 

3. EFFECTIVE DATE

 

See Block 16C

  4. REQUISITION/PURCHASE REQ. NO.  

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)   (x)     9A. AMENDMENT OF SOLICITATION NO.                        

FENEX BIOPHARMACEUTICALS, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

5501 OBERLIN DR

SAN DIEGO CA 921211718

     

9B. DATED (SEE ITEM 11)

 

  X    

10A. MODIFICATION OF CONTRACT/ORDER NO

HHSO100201000045C

         

10B.  DATED (SEE ITEM 13)

  CODE        1358378  

FACILITY CODE  

 

     

 

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 ACKNOWLEDGMENT 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 APPLIES ONLY TO MODIFICATIONS 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.

X        

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:

 

X  

D.    OTHER (Specify type of modification and authority)

 

No Cost Extension

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

Period of Performance: 07/30/2010 to 03/30/2012

The purpose of this modification is to issue a change order and to modify the
original contract to extend the period of performance to 3/30/2012. The period
of performance for the base period is now 07/30/2010 to 03/30/2012.

This modification does not increase the overall contract value or period of
performance of the original contract.

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    16A. NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

/s/ Bertrand C. Liang

  

GLYNIS M. FISHER

 

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

--------------------------------------------------------------------------------

15B. CONTRACTOR/OFFEROR   15C. DATE SIGNED      16B. UNITED STATES OF AMERICA  
16C. DATE SIGNED      

Bertrand C. Liang CEO                                                         

(Signature of person authorized to sign)

  12/9/11   

/s/ Glynis M. Fisher                                                         

(Signature of Contracting Officer)

 

  12/9/11

NSN 7540-01-152-8070

Previous edition unusable

  30-105   

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.

 

--------------------------------------------------------------------------------

SUMMARY OF CHANGES

Beginning with the effective date of this modification, the contract between the
Government and Contractor now reads:

 

1) No-Cost Extension to Base Period

The period of performance for the base year will be extended via no cost
extension. Period of performance date are adjusted in the contract and now reads
as follows:

 

a. SF 26, Block 15 Period: Period: July 30, 2010 through March 30, 2012.

 

b. UNDER SECTION B (SUPPLIES OR SERVICES and PRICES/COSTS), ARTICLE B.2
(ESTIMATED COST AND FIXED FEE), d. replace with:

It is estimated that the amount currently allotted will cover performance of the
contract through March 31, 2012.

UNDER SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS, Article B.2 ESTIMATED
COST AND FIXED FEE, the dates shall be changed to the following:

 

CLIN

  

Base

Period

  

Supplies/Services

  

Quantity

(Units)

   Cost      Fixed Fee     

Total Estimated

Cost Plus Fixed

 

0001

   07/30/2010-

03/30/2012

  

[***]

   1 Job    $ 9,428,959       $ 660,027       $ 10,088,986   

UNDER SECTION B– SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.3 INVOICE
OPTION PRICES, shall be changed to the following:

 

CLIN

   Option   

Supplies/Services

   Quantity    Cost      Fixed Fee      Estimated  

1001

   03/31/2012-

07/30/2013

  

[***]

   1 Job    $ 1,486,185       $ 104,033       $ 1,590,218   

1002

   07/31/2013-

01/30/2015

  

[***]

   1 Job    $ 958,097       $ 67,067       $ 1,025,164   

2001

   03/31/2012-
09/30/2013   

[***]

   1 Job    $ 4,008,626       $ 280,604       $ 4,289,230   

2002

   10/01/2013-
09/30/2014   

[***]

   1 Job    $ 1,013,298       $ 70,931       $ 1,084,229   

2003

   10/01/2014-
10/30/2015   

[***]

   1 Job    $ 689,544       $ 48,268       $ 737,812   

UNDER SECTION B– SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.4.b. TRAVEL,
shall be changed to the following:

 

  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 $7,619 in the twenty month base period
(07/30/2010-03/30/2012) without the prior written approval of 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.

--------------------------------------------------------------------------------

  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 Federal Acquisition Regulations (FAR) 31.2 - Contracts with
Commercial Organizations, Subsection 31.205-46, Travel Costs.

 

c. 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 March 30, 2012. 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   

Supplies/Services

   Quantity    Cost      Fixed Fee      Estimated  

1001

   03/31/2012-

07/30/2013

  

[***]

   1 Job    $ 1,486,185       $ 104,033       $ 1,590,218   

1002

   07/31/2013-

01/30/2015

  

[***]

   1 Job    $ 958,097       $ 67,067       $ 1,025,164   

2001

   03/31/2012-
09/30/2013   

[***]

   1 Job    $ 4,008,626       $ 280,604       $ 4,289,230   

2002

   10/01/2013-
09/30/2014   

[***]

   1 Job    $ 1,013,298       $ 70,931       $ 1,084,229   

2003

   10/01/2014-
10/30/2015   

[***]

   1 Job    $ 689,544       $ 48,268       $ 737,812   

 

d. UNDER SECTION G – CONTRACT ADMINISTRATION DATA, G.8. POST AWARD EVALUATION OF
CONTRACTOR PERFORMANCE, a., shall be changed to the following:

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 April 30, 2012.

Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be permitted
thirty days to review the document and to submit additional information or a
rebutting statement. If agreement cannot be reached between the parties, the
matter will be referred to an individual one level above the Contracting Officer
whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any,
will be retained as part of the contract file, and may be used to support future
award decisions.

 

2) Change Order

UNDER SECTION J - LIST OF ATTACHMENTS, Attachment 1. Statement of Work, the
following tasks shall be added:

6.3.1.1 Milestone 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.

--------------------------------------------------------------------------------

Deliverable for 6.3.1.1 [***]

6.3.1.2 Milestone 2: [***]

Deliverable for 6.3.1.2 [***]

6.3.1.3 Milestone 3: [***]

Deliverable for 6.3.1.3 Phase 3: [***]

(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.

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT  

1. CONTRACT ID CODE

 

PAGE OF PAGES

1        |        3

2. AMENDMENT/MODIFICATION NO.

 

0003

 

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)   (x)     9A. AMENDMENT OF SOLICITATION NO.                        

FENEX BIOPHARMACEUTICALS, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

5501 OBERLIN DR

SAN DIEGO CA 921211718

     

9B. DATED (SEE ITEM 11)

 

  X    

10A. MODIFICATION OF CONTRACT/ORDER NO

HHSO100201000045C

          10B. DATED (SEE ITEM 13)   CODE         1358378  

FACILITY CODE  

 

     

 

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 ACKNOWLEDGMENT 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 APPLIES ONLY TO MODIFICATIONS 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:

 

X  

D.    OTHER (Specify type of modification and authority)

 

No Cost Extension

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

Period of Performance: 07/30/2010 to 04/30/2012

The purpose of this modification is to issue a No Cost Extension to modify the
contract to extend the period of performance to 4/30/2012. The period of
performance for the base period is now 07/30/2010 to 04/30/2012.

This modification does not increase the overall contract value of the original
contract.

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    16A. NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

Charles H. Squires V.P. Discovery & Partnerships

  

GLYNIS M. FISHER

 

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

--------------------------------------------------------------------------------

15B. CONTRACTOR/OFFEROR   15C. DATE SIGNED      16B. UNITED STATES OF AMERICA  
16C. DATE SIGNED      

/s/ Charles H. Squires                                                     

(Signature of person authorized to sign)

  3/29/12   

/s/ Glynis M. Fisher                                                 

(Signature of Contracting Officer)

 

  3/29/2012

NSN 7540-01-152-8070

Previous edition unusable

 

30-105

  

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.

-2-

--------------------------------------------------------------------------------

SUMMARY OF CHANGES

Beginning with the effective date of this modification, the contract between the
Government and Contractor now reads:

 

1) No-Cost Extension to Base Period

The period of performance for the base year will be extended via no cost
extension. Period of performance date are adjusted in the contract and now reads
as follows:

 

a. SF 26, Block 15 Period: Period: July 30, 2010 through April 30, 2012.

 

b. UNDER SECTION B (SUPPLIES OR SERVICES and PRICES/COSTS), ARTICLE B.2
(ESTIMATED COST AND FIXED FEE), d. replace with:

It is estimated that the amount currently allotted will cover performance of the
contract through April 30, 2012.

UNDER SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS, Article B.2 ESTIMATED
COST AND FIXED FEE, the dates shall be changed to the following:

 

CLIN

  

Base

Period

  

Supplies/Services

  

Quantity

(Units)

   Cost      Fixed Fee     

Total Estimated

Cost Plus Fixed

 

0001

  

07/30/2010-

04/30/2012

   [***]    1 Job    $ 9,428,959       $ 660,027       $ 10,088,986   

UNDER SECTION B– SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.3 INVOICE
OPTION PRICES, shall be changed to the following:

 

CLIN

  

Option

  

Supplies/Services

   Quantity    Cost      Fixed Fee      Estimated  

1001

  

04/30/2012-

08/30/2013

   [***]    1 Job    $ 1,486,185       $ 104,033       $ 1,590,218   

1002

  

07/31/2013-

09/30/2015

   [***]    1 Job    $ 958,097       $ 67,067       $ 1,025,164   

2001

  

04/30/2012-

10/30/2013

   [***]    1 Job    $ 4,008,626       $ 280,604       $ 4,289,230   

2002

  

10/01/2013-

10/30/2014

   [***]    1 Job    $ 1,013,298       $ 70,931       $ 1,084,229   

2003

  

10/01/2014-

11/30/2015

   [***]    1 Job    $ 689,544       $ 48,268       $ 737,812   

UNDER SECTION B– SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.4.b. TRAVEL,
shall be changed to the following:

 

  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 $7,619 in the twenty month base period
(07/30/2010-04/30/2012) without the prior written approval of 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.

-3-

--------------------------------------------------------------------------------

  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 Federal Acquisition Regulations (FAR) 31.2 - Contracts with
Commercial Organizations, Subsection 31.205-46, Travel Costs.

 

c. 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 April 30, 2012.

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

  

Supplies/Services

   Quantity    Cost      Fixed Fee      Estimated  

1001

  

04/30/2012-

08/30/2013

   [***]    1 Job    $ 1,486,185       $ 104,033       $ 1,590,218   

1002

  

07/31/2013-

02/30/2015

   [***]    1 Job    $ 958,097       $ 67,067       $ 1,025,164   

2001

  

04/30/2012-

08/30/2013

   [***]    1 Job    $ 4,008,626       $ 280,604       $ 4,289,230   

2002

  

10/01/2013-

09/30/2014

   [***]    1 Job    $ 1,013,298       $ 70,931       $ 1,084,229   

2003

  

10/01/2014-

11/30/2015

   [***]    1 Job    $ 689,544       $ 48,268       $ 737,812   

 

d. UNDER SECTION G – CONTRACT ADMINISTRATION DATA, G.8. POST AWARD EVALUATION OF
CONTRACTOR PERFORMANCE, a., shall be changed to the following:

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 May 30, 2012.

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.

(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.

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT   1. CONTRACT ID CODE  

PAGE OF PAGES

1        |        2

2. AMENDMENT/MODIFICATION NO.

 

0004

     

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)     (x)    

9A.    AMENDMENT OF SOLICITATION NO.

                     

FENEX BIOPHARMACEUTICALS, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

5501 OBERLIN DR

SAN DIEGO CA 921211718

     

9B.    DATED (SEE ITEM 11)

 

    X    

10A. MODIFICATION OF CONTRACT/ORDER NO

HHSO100201000045C

 

   

10B.  DATED (SEE ITEM 13)

 

07/30/2010

 

CODE        1358378  

FACILITY CODE    

 

     

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 ACKNOWLEDGMENT 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 APPLIES ONLY TO MODIFICATIONS 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.

X        

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:

 

X  

D.    OTHER (Specify type of modification and authority)

 

Mutual agreement of the parties.

E. IMPORTANT: Contractor        ¨ is not,        x is required to sign this
document and return     1     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) revise Attachment 1 (Statement of
Work) in Section J; (2) update the option periods accordingly in Section B and
Section F; and (3) update the Key Personnel defined in Section G.

This modification does not alter the deliverables or obligated value of the
original contract.

FOB: Destination

Period of Performance: 07/30/2010 to 04/30/2012

Continued …

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    16A. NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

Charles H. Squires V.P. Discovery & Partnerships

   CAROLYN R. KEESEMAN 15B. CONTRACTOR/OFFEROR      15C. DATE SIGNED      16B.
UNITED STATES OF AMERICA      16C. DATE SIGNED      

/s/ Charles H. Squires

(Signature of person authorized to sign)

       April 12, 2012     

/s/ Carolyn R. Keeseman

(Signature of Contracting Officer)

 

       4/12/2012

NSN 7540-01-152-8070

Previous edition unusable

  30-105   

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

HHSO100201000045C/0004

   PAGE OF        

2        |        2

NAME OF OFFEROR OR CONTRACTOR

FENEX BIOPHARMACEUTICALS, INC. 1358378

    ITEM NO.    

(A)

 

SUPPLIES/SERVICES

(B)

 

  QUANTITY  

(C)

 

  UNIT  

(D)

 

  UNIT PRICE  

(E)

 

  AMOUNT  

(F)

 

Add Item 2 as follows:

                  2  

[***]

 

Add Item 3 as follows:

 

[***]

 

$2,310,123.00 (Option Line Item)

            0.00       3  

Cancel Item 1001 in its entirety.

 

Cancel Item 1002 in its entirety.

 

Cancel Item 2001 in its entirety.

 

Cancel Item 2002 in its entirety.

 

Cancel Item 2003 in its entirety.

              0.00

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.

-2-

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT   1. CONTRACT ID CODE  

PAGE OF PAGES

1        |        2

2. AMENDMENT/MODIFICATION NO.

 

0005

 

3. EFFECTIVE DATE

 

04/15/2012

 

4. REQUISITION/PURCHASE REQ. NO.

 

OS86617

  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)     (x)    

9A.    AMENDMENT OF SOLICITATION NO.

               

FENEX BIOPHARMACEUTICALS, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

5501 OBERLIN DR

SAN DIEGO CA 921211718

     

9B.    DATED (SEE ITEM 11)

 

    X    

10A. MODIFICATION OF CONTRACT/ORDER NO.

HHSO100201000045C

 

         

10B.  DATED (SEE ITEM 13)

CODE        1358378  

FACILITY CODE    

 

     

 

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 ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this
amendment you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

 

12. ACCOUNTING AND APPROPRIATION DATA (if required)
                                        Net Increase:
                                                 $5,794,316.00

2012.1992002.25106

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS 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:

 

X  

D.    OTHER (Specify type of modification and authority)

 

FAR 52.217-9 Option to Extend the Term of the Contract

E. IMPORTANT: Contractor        x is not,        ¨ is required to sign this
document and return            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 exercise Option 1 (CLIN 00002) for a term
of 4/15/12 - 4/30/13.

Delivery Location Code: HHS

HHS

200 Independence Avenue, SW

Washington DC 20201 US

Continued …

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    16A. NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

Charles H. Squires V.P. Discovery & Partnerships

   CAROLYN R. KEESEMAN 15B. CONTRACTOR/OFFEROR      15C. DATE SIGNED      16B.
UNITED STATES OF AMERICA      16C. DATE SIGNED      

/s/ Charles H. Squires

(Signature of person authorized to sign)

       4/12/2012   

/s/ Carolyn R. Keeseman

(Signature of Contracting Officer)

 

       4/12/2012

NSN 7540-01-152-8070

Previous edition unusable

    

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

HHSO100201000045C/0005

   PAGE OF        

2        |        2

NAME OF OFFEROR OR CONTRACTOR

FENEX BIOPHARMACEUTICALS, INC. 1358378

    ITEM NO.    

(A)

 

SUPPLIES/SERVICES

(B)

 

  QUANTITY  

(C)

 

  UNIT  

(D)

 

  UNIT PRICE  

(E)

 

  AMOUNT  

(F)

 

Appr. Yr.: 2012 CAN: 1992002 Object Class: 25106

FOB: Destination

Period of Performance: 07/30/2010 to 04/30/2013

 

Change Item 2 to read as follows (amount shown is the obligated amount):

                  2  

[***]

 

$5,794,316.00

              5,794,316.00

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.

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT   1. CONTRACT ID CODE  

PAGE OF PAGES

1        |        3

2. AMENDMENT/MODIFICATION NO.

 

0006

     

3. EFFECTIVE DATE

 

See Block 16C

 

4. REQUISITION/PURCHASE REQ. NO.

 

OS107720

  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)     (x)     9A. AMENDMENT OF SOLICITATION NO.                        

PFENEX, INC 1358378

5501 OBERLIN DR

SAN DIEGO CA 921211718

         

9B. DATED (SEE ITEM 11)

 

        X    

10A. MODIFICATION OF CONTRACT/ORDER NO.

HHSO100201000045C

          10B. DATED (SEE ITEM 13) CODE        1358378  

FACILITY CODE

 

      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 ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this
amendment you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

 

12. ACCOUNTING AND APPROPRIATION DATA (if
required)                                         Net
Increase:                                         $10,581.00

See Schedule

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS 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.

      X  

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)

 

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 correct the original discrepancy between
the contract document itself and the PRISM award system.

FOB: Destination

Period of Performance: 07/30/2010 to 04/30/2013

Change Item 1 to read as follows (amount shown is the obligated amount):

 

1    [***]    10,581.00        

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    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      

_____________________________________

(Signature of person authorized to sign)

      

/s/  MATTHEW A. MCCORD                                    

(Signature of Contracting Officer)

 

  4/11/13

NSN 7540-01-152-8070

Previous edition unusable

    

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

HHSO100201000045C/0006

   PAGE         OF        

2        |        3

NAME OF OFFEROR OR CONTRACTOR

PFENEX, INC 1358378

    ITEM NO.    

(A)

 

SUPPLIES/SERVICES

(B)

 

  QUANTITY  

(C)

 

  UNIT  

(D)

 

  UNIT PRICE  

(E)

 

  AMOUNT  

(F)

   

[***]

 

$10,581.00

 

Delivery: 02/23/2011

Delivery Location Code: HHS

HHS

200 Independence Avenue, SW

Washington DC 20201 US

Amount: $10,078,405.00

Accounting Info:

 

2010.1990087.25106 Appr. Yr.: 2010 CAN: 1990087 Object Class: 25106

 

Funded: $0.00

 

Delivery: 04/11/2013

Delivery Location Code: OS-BARDA-SWITZER

OS-BARDA-SWITZER

330 Independence Ave, SW, Rm G644

Washington DC 20201 US

Amount: $10,581.00

Accounting Info:

 

2010.1990087.25106.00000000.00 Appr. Yr.: 2010 CAN: 1990087 Object Class: 25106

 

Funded: $10,581.00

               

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.

--------------------------------------------------------------------------------

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Beginning with the effective date of this modification, the contract between the
Government and Contractor is hereby updated as follows:

 

  1) [***]

 

  2) Terms of condition of this contract and prior modifications remain
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.

-3-

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFCATION OF CONTRACT   1 CONTRACT ID CODE      

PAGE OF PAGES

1                |             35

2 AMENDMENT/MODIFICATION NO

 

0007

 

3 EFFECTIVE DATE

 

See Block 16C

  4 REQUISITON/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)

  x    

9A AMENDMENT OF SOLICITATION NO

 

                     

FENEX BIOPHARMACEUTICALS, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

5501 OBERLINE DR

SAN DIEGTO CA 921211718

     

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 SOLICATIONS

 

¨ 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 DESINGATED 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 APPROPRIATEION 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 PUIRSUANT 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 AUTHROITY OF FAR 43 103(b)

   

 

C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AURHTORITY OF

   

 

D.    OTHER (Specify type of modification and authority)

 

Mutual agreement of parties (FAR 43.103(a) (3) )

E. IMPORTANT:             Contractor         ¨ is not        ¨ is required to
sign this document and return     0     copies to the issuing office

 

 

14 DESCRITION 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, ell terms end 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)

 

   16A NAME AND TITLE OF CONTRACTING OFFICER (Type or print) Charles H. Squires,
V.P. Discovery    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)

 

[***] Certain information in this 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-

--------------------------------------------------------------------------------

     

Prescribed by GSA

FAR (48 CFR) 53 243

 

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

[*]    Principal Investigator [*]    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.

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT  

1. CONTRACT ID CODE

 

PAGE OF PAGES

1        |        53

2. AMENDMENT/MODIFICATION NO.

 

0008

 

3. EFFECTIVE DATE

 

See Block 16C

 

4. REQUISITION/PURCHASE REQ. NO.

 

OS119304

 

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)  
(x)      9A. AMENDMENT OF SOLICITATION NO.

 

PFENEX, INC 1358378

                   

FENEX BIOPHARMACEUTICALS, INC.

10790 ROSELLE ST

     

9B. DATED (SEE ITEM 11)

 

SAN DIEGO CA 921211718       x     

10A. MODIFICATION OF CONTRACT/ORDER NO.

HHSO100201000045C

 

          10B. DATED (SEE ITEM 13) CODE            1358378  
FACILITY CODE                         

 

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 ACKNOWLEDGMENT 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)

..2013.1992002.25106

 

 

Net Increase:

   

 

$7,962,932.00

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS 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)

 

X  

C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

Mutual agreement of parties (FAR 43.103(a)(3))

   

D.    OTHER (Specify type of modification and authority)

 

E. IMPORTANT: Contractor        ¨ is not,        x is required to sign this
document and return     1     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

[***]

Delivery Location Code: HHS

HHS

200 Independence Avenue, SW

Washington DC 20201 US

Continued  …

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    16A. NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

Patrick Lucy, VP Business Development

  

 

GLYNIS M. FISHER

15B. CONTRACTOR/OFFEROR     15C. DATE SIGNED      16B. UNITED STATES OF AMERICA
    16C. DATE SIGNED      

/s/ Patrick Lucy

      9/13/13      

/s/ Glynis M. Fisher

      9/13/2013 (Signature of person authorized to sign)       

(Signature of Contracting Officer)

 

   

NSN 7540-01-152-8070

Previous edition unusable

    

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

HHSO100201000045C/0008

  PAGE OF               2        |        53

NAME OF OFFEROR OR CONTRACTOR

PFENEX, INC 1358378

  ITEM NO.  

(A)

 

SUPPLIES/SERVICES

(B)

 

  QUANTITY  

(C)

 

  UNIT  

(D)

 

  UNIT PRICE  

(E)

 

  AMOUNT  

(F)

3  

Appr. Yr.: 2013 CAN: 1992002 Object Class: 25106

FOB: Destination

Period of Performance: 07/30/2010 to 12/31/2014

 

Change Item 3 to read as follows (amount shown is the obligated amount):

 

0003A: [***]

            7,962,932.00          

[***]

 

               

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
contract HHSO100201000045C between the Government and Contractor now read:

 

  1. Revision of Option Period 2.

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, the options shall be changed to the following:

 

CLIN

   SUB-
CLIN    Period of
Performance      Type     

Supplies/Services

   Quantity    Estimated Cost      Fixed Fee      Estimated
Total  

0002

       

 

04/15/2012 -

10/31/2013

  

 

     CPFF       [***]    1 Job    $ 5,415,249       $ 379,067       $ 5,794,316
  

0003

   0003A     

 

01/1/2013 -

12/31/2014

  

 

     CPFF       [***]    1 Job    $ 6,680,310       $ 467,622       $ 7,147,932
           Delivery Date         Type      Supplies/Services    Quantity      
     Price       0003B      10/15/2013         FFP       [***]    1 Set of Data
Deliverables          $ 815,000                           

 

 

 

Total Estimated CLIN 003:

  

$ 7,962,932                           

 

 

 

 

  (b) UNDER SECTION F – DELIVERIES OR PERFORMANCE, ARTICLE F.1 PERIOD OF
PERFORMANCE, shall be changed to the following:

a. The period of performance of this contract, including all options shall be
from July 30, 2010 through December 31, 2014. Specific periods of performance by
option period under this contract are delineated in Section B of this contract.

 

  2. Updates to FAR Clauses incorporated by Reference

UNDER SECTION I – CONTRACT CLAUSES, ARTICLE I.1. is updated as follows
(additions in red):

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

 

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

--------------------------------------------------------------------------------

52.203-14 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) 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

 

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

--------------------------------------------------------------------------------

52.242-1    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) 52.243-1    Aug 1987    Changes-Fixed Price 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 52.246-2    Aug 1996    Inspection of
Supplies—Fixed-Price 52.246-4    Aug 1996    Inspection of Services—Fixed-Price
52.246-23    Feb 1997    Limitation of Liability (Over $100,000) 52.249-2   
Apr 2012    Termination for Convenience of the Government (Fixed Price) 52.249-6
   May 2004    Termination (Cost-Reimbursement) 52.249-8    May 2004    Default
(Fixed-Price Supply and Service) 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)

 

  3. HHSAR Clause Updates

UNDER SECTION I – CONTRACT CLAUSES, ARTICLE I.5. shall be added as follows:

ARTICLE I.5. ADDITIONAL HHSAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text:

 

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

--------------------------------------------------------------------------------

352.231-70 Salary rate limitation (AUG 2012)

(a) Pursuant to the current and applicable prior HHS appropriations acts, the
Contractor shall not use contract funds to pay the direct salary of an
individual at a rate in excess of the Federal Executive Schedule Level in effect
on the date the funding was obligated (the effective date of the contract
action). Funding obligated on or after December 23, 2011 cannot be used to pay
the direct salary of an individual at a rate in excess of Federal Executive
Schedule Level II.

(b) For purposes of the salary rate limitation, the terms “direct salary,”
“salary”, and “institutional base salary”, have the same meaning and are
collectively referred to as “direct salary”, in this clause. An individual’s
direct salary is the annual compensation that the Contractor pays for an
individual’s direct effort (costs) under the contract. Direct salary excludes
any income that an individual may be permitted to earn outside of duties to the
Contractor. Direct salary also excludes fringe benefits, overhead, and general
and administrative expenses (also referred to as indirect costs or facilities
and administrative [F&A] costs).

Note: The salary rate limitation does not restrict the salary that an
organization may pay an individual working under an HHS contract or order; it
merely limits the portion of that salary that may be paid with contract funds.

(c) The salary rate limitation also applies to individuals under subcontracts.
If this is a multiple-year contract or order, it may be subject to unilateral
modification by the Contracting Officer to ensure that an individual is not paid
at a rate that exceeds the salary rate limitation provision established in the
HHS appropriations act in effect when the expense is incurred regardless of the
rate initially used to establish contract or order funding.

(d) See the salaries and wages pay tables on the U.S. Office of Personnel
Management Web site for Federal Executive Schedule salary levels that apply to
the current and prior periods.

(End of clause)

 

  4. Administrative Updates.

 

  (a) Under SECTION G - CONTRACT ADMINISTRATION DATA and in accordance with
ARTICLE G.2. CONTRACTING OFFICER, the official Contracting Officer on record is
hereby changed from [*] to _[*]. Additionally, the official Contract Specialist
on record is changed from [*] to [*]. Any reference to Contracting Officer or
Contract Specialist throughout the contract is to be updated accordingly.

[*]

Contracting Officer

[*]

[*]

[*]

Contract Specialist

[*]

[*]

 

  (b) Under SECTION G - CONTRACT ADMINISTRATION DATA, ARTICLE G.1. CONTRACTING
OFFICER’S TECHNICAL REPRESENTATIVE (COTR) shall be changed to the following,
effective as of August 15, 2012.

ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer’s Technical Representative (COR) will
represent the Government for the purpose of this contract:

[*]

Contracting Officer 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.

--------------------------------------------------------------------------------

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

[*] (Office)

[*]

Alternate COR: 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

[*] (Office)

[*]

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 Government may unilaterally change its COR designation.

 

  (c) Any remaining reference to Contracting Officer’s Technical Representative
(or COTR) in the contract are hereby deleted and replaced with Contracting
Officer’s Representative (or COR).

 

  5. 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 revised as
follows (referenced SOW attached herein):

 

  1. Statement of Work

Statement of Work, Dated September 9, 2013 (45 Pages).

(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.

--------------------------------------------------------------------------------

9/9/2013

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.

-8-

--------------------------------------------------------------------------------

OMB APPROVAL 2700-0042

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT  

 

1 CONTRACT ID CODE

 

   N/A

 

PAGE OF PAGES

1        |        2

2 AMENDMENT/MODIFICATION NO.

 

        0009

 

3 EFFECTIVE DATE

 

  See Block 16C

 

4 REQUISITION/PURCHASE REQ NO.

 

N/A

 

5 PROJECT NO (if applicable)

6 ISSUED BY   CODE         7 ADMINISTERED BY (If other than Item 6)   CODE      

 

Office of Acquisitions Management, Contracts, and Grants (AMCG)

330 Independence Ave., S.W. Room G640

Washington, D.C. 20201

 

            8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and
ZIP Code)         (  )     9A AMENDMENT OF SOLICITATION NO

 

Pfenex Biopharmaceuticals, Inc.

                     

10790 Roselle ST

San Diego, CA 92121

     

9B DATED (SEE ITEM 11)

 

     

10A MODIFICATION OF CONTRACT/ORDER NO

 

      HHSO100201000045C

        X     10B DATED (SEE ITEM 13) CODE            DUNS: 013603710   FACILITY
CODE    

 

July 30, 2010

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATION

 

 

¨ 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 one (1) copy 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 ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATA 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 data specified.

 

12 ACCOUNTING AND APPROPRIATION DATA

No change in data.

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

   

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).

X  

C     THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

Mutual agreement of the parties — FAR 43.103(a)(3)

   

D     OTHER (Specify type of modification and authority)

 

E. IMPORTANT: Contractor        ¨ is not,        x is required to sign this
document and return     1     copy to the issuing office.

 

14 DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

PURPOSE: [***]

All other terms and conditions remain unchanged.

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A NAME AND TITLE OF SIGNER (Type or print)        16A NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

Patrick Lucy, V.P. of BD

      

 

Thomas P. Hastings,

Contracting Officer. AMCG, ASPR, OS, DHHS

    15B. CONTRACTOR/OFFEROR     15C. DATE SIGNED      16B. UNITED STATES OF
AMERICA     16C. DATE SIGNED      

/s/ Patrick Lucy

      1/23/14     

/s/ Thomas P. Hastings

      1/27/14

(Signature of person authorized to sign)

 

      

(Signature of Contracting Officer)

 

   

NSN 7540-01.152-8070

PREVIOUS EDITION UNUSABLE

 

30-105

  

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.

 

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

--------------------------------------------------------------------------------

BEGINNING WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE CONTRACT IS MODIFIED
AS FOLLOWS:

1. The end date for the period of performance of CLIN 0002, as used throughout
the contract, is modified to August 30, 2014.

2. SECTION G, ARTICLE G.3. is modified to delete the following Key Personnel
position from the contract:

 

Name

  

Title

[*]    Deputy Principal Investigator

3. SECTION G is modified to include the additional following article:

ARTICLE G.10. TRANSFER OF ACCOUNTABILITY OF GOVERNMENT PROPERTY

a. Accountability of government property listed in this Article is hereby
transferred in full from this contract to contract number HHSN272201300029C. The
listing of property and vendor name are as follows:

 

  1. [***]

 

  2. [***]

b. Pursuant to FAR 45.106, Transferring Accountability, an equivalent contract
modification shall be executed for the contract controlling the gaining office’s
activities. The property detailed in this Article is considered
Government-furnished property.

c. The property identified in this Article is subject to the requirements of FAR
52.245-1, Government Property, in addition to the requirements set forth in
Article G.7. Government Property of this contract.

d. This transfer does not affect the total amount of this contract.

ALL OTHER TERMS AND CONDITIONS OF THE CONTRACT REMAIN UNCHANGED AND 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.

--------------------------------------------------------------------------------

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT      

1. CONTRACT ID CODE

 

PAGE OF PAGES

1        |        2

2. AMENDMENT/MODIFICATION NO.  

0010

 

 3. EFFECTIVE DATE

   See Block 16C

 

4. REQUISITION/PURCHASE REQ. NO.  

OS145133

 

5. PROJECT NO (If applicable)

 

6. ISSUED BY   CODE     HHS/OS/ASPR/BARDA  
7. ADMINISTERED BY (If other than Item 6)   CODE    ASPR-BARDA02

 

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)

 

PFENEX, INC. 1358378

FENEX BIOPHARMACEUTICALS, INC.

10790 ROSELLE ST

SAN DIEGO CA 921211718

  (x)     9A. AMENDMENT OF SOLICITATION NO.            

9B. DATED (SEE ITEM 11)

 

  X    

10A. MODIFICATION OF CONTRACT/ORDER NO

HHSO100201000045C

      10B. DATED (SEE ITEM 13) CODE    1358378      

FACILITY CODE

 

     

 

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
ACKNOWLEDGMENT 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)

2015.1992015.25106

      Net Increase:                                         $1,394,958.30

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS 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).

 

X  

C.    THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

FAR 52.243-2 Alternate I (Apr 1987) Changes – Cost reimbursement and mutual
agreement of parties

   

D.    OTHER (Specify type of modification and authority)

 

E. IMPORTANT: Contractor        ¨ is not,        x is required to sign this
document and return     1     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. Increase the Estimated Cost and Fixed Fee by $1,394,958

2. Extend the Period of Performance of subCLIN 0003A to 5/8/2015 3. Supplement
the Statement of Work to [***] 4. Update Article G.2 for a new contract
specialist.

See Attached

Continued …

Except as provided herein, all terms and conditions of the document referenced
in item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)    16A. NAME AND TITLE OF
CONTRACTING OFFICER (Type or print)

 

Patrick Lucy Chief Business Officer

   THOMAS P. HASTINGS 15B. CONTRACTOR/OFFEROR     15C. DATE SIGNED      16B.
UNITED STATES OF AMERICA     16C. DATE SIGNED      

/s/ Patrick Lucy

(Signature of person authorized to sign)

     

12/18/14

 

  

/s/ Thomas P. Hastings

(Signature of Contracting Officer)

 

     

12/18/14

 

NSN 7540-01-152-8070

Previous edition unusable

  30-105   

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

HHSO100201000045C/0010

  PAGE OF               2        |        2

NAME OF OFFEROR OR CONTRACTOR

PFENEX, INC 1358378

  ITEM NO.  

(A)

 

SUPPLIES/SERVICES

(B)

 

  QUANTITY  

(C)

 

  UNIT  

(D)

 

  UNIT PRICE  

(E)

 

  AMOUNT  

(F)

 

Delivery: 11/06/2014

Delivery Location Code: HHS/OS/ASPR

HHS/OS/ASPR

200 C St SW

WASHINGTON DC 20201 US

 

Appr. Yr.: 2015 CAN: 1992015 Object Class: 25106

FOB: Destination

Period of Performance: 07/30/2010 to 05/08/2015

 

Add Item 2004 as follows:

                  2004  

ASPR-15-00409 — Additional funds under Option 2

of Pfenex Inc HHS01002011000045C

Obligated Amount: $1,394,958.00

 

              1,394,958.00

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
contract HHSO100201000045C between the Government and the Contractor now read:

Under SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS, ARTICLE B.3 INVOICE
OPTION PRICES, the estimated cost and fixed fee of subCLIN 0003A is increased by
$1,394,958 [***]:

 

CLIN

   SUB-CLIN    Period of
Performance
or Delivery
Date    Type   

Supplies /

Services

   Quantity    Estimated
Cost     Fixed
Fee     Total
Estimated
Cost or
Price   [***]       [***]    [***]   

[***]

   [***]      [*** ]      [*** ]      [*** ]  [***]    [***]    [***]    [***]
  

[***]

   [***]      [*** ]      [*** ]      [*** ]     [***]    [***]    [***]   

[***]

   [***]      [*** ]      [*** ]      [*** ]                       

 

 

 

Total Estimated Cost for CLIN 0003

  [*** ]                       

 

 

 

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT, ARTICLE C.1. STATEMENT OF
WORK, is hereby modified as follows:

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 November 7, 2014, set forth in SECTION J-List of
Attachments.

SECTION F – DELIVERIES OR PERFORMANCE, ARTICLE F.1 PERIOD OF PERFORMANCE,
paragraph a. is hereby modified to read 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.

 

--------------------------------------------------------------------------------

  a) The period of performance of this contract, including options, shall be
from July 30, 2010 through May 8, 2015. Specific periods of performance by
option period of this contract are delineated in Section B of this contract.

Under SECTION G – CONTRACT DATA ADMINISTRATION and in accordance with ARTICLE
G.2. CONTRATING OFFICER, the official Contract Specialist on record is changed
from [*] to [*]. Any reference to the Contracting Specialist throughout the
contract is to be updated accordingly.

[*].

Contract Specialist

[*]

[*]

Section J – List of Attachments 1.) STATEMENT OF WORK is hereby modified as
follows:

 

  1. Statement of Work

[***]

END OF MODIFICATION 10 TO HHSO100201000045C

 

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

 

--------------------------------------------------------------------------------

Statement of Work

[***]

 

[***] Certain information in this 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-