Enanta has requested that portions of this document be accorded confidential treatment pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

EX-10.3 8 d401292dex103.htm AGREEMENT WITH THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES Agreement with the National Institute of Allergy and Infectious Diseases

Exhibit 10.3

Enanta has requested that portions of this document be accorded confidential treatment pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended.

 

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

CONTRACT TABLE OF CONTENTS

 

PART I - THE SCHEDULE					1
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS					1
ARTICLE B.1.		BRIEF DESCRIPTION OF SUPPLIES OR SERVICES			1
ARTICLE B.2.		ESTIMATED COST - OPTION			1
ARTICLE B.3.		ADVANCE UNDERSTANDINGS			1
ARTICLE B.4.		PROVISIONS APPLICABLE TO DIRECT COSTS			2
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT					4
ARTICLE C.1.		STATEMENT OF WORK			4
ARTICLE C.2.		REPORTING REQUIREMENTS			4
ARTICLE C.3.		INVENTION REPORTING REQUIREMENT			7
SECTION D - PACKAGING, MARKING AND SHIPPING					9
SECTION E - INSPECTION AND ACCEPTANCE					10
SECTION F - DELIVERIES OR PERFORMANCE					11
ARTICLE F.1.		PERIOD OF PERFORMANCE			11
ARTICLE F.2.		DELIVERIES			11
ARTICLE F.3.		CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998			13
SECTION G - CONTRACT ADMINISTRATION DATA					15
ARTICLE G.1.		CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR			15
ARTICLE G.2.		KEY PERSONNEL, HHSAR 352.242-70 (JANUARY 2006			15
ARTICLE G.3.		INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT			16
ARTICLE G.4.		INDIRECT COST RATES			17
ARTICLE G.5.		POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE			17
SECTION H - SPECIAL CONTRACT REQUIREMENTS					19
ARTICLE H.1.		PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(B) (JANUARY 2006			19
ARTICLE H.2.		HUMAN SUBJECTS			19
ARTICLE H.3.		REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS			19
ARTICLE H.4.		DATA AND SAFETY MONITORING IN CLINICAL TRIALS			20
ARTICLE H.5.		REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV			20
ARTICLE H.6.		HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE			21
ARTICLE H.7.		SALARY RATE LIMITATION, HHSAR 352.231-70 (JANUARY 2010			21
ARTICLE H.8.		NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH			22

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- i -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

ARTICLE H.9.		NEEDLE DISTRIBUTION			22
ARTICLE H.10.		PRESS RELEASES			22
ARTICLE H.11.		RESTRICTION ON ABORTIONS			22
ARTICLE H.12.		CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH			22
ARTICLE H.13.		DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION			23
ARTICLE H.14.		RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS			23
ARTICLE H.15.		CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(B) (OCTOBER 2009			23
ARTICLE H.16.		ANIMAL WELFARE			23
ARTICLE H.17.		OPTION PROVISION			24
ARTICLE H.18.		INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS			24
ARTICLE H.19.		PUBLICATION AND PUBLICITY			25
ARTICLE H.20.		REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE			25
ARTICLE H.21.		SHARING RESEARCH DATA			25
ARTICLE H.22.		POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS			26
ARTICLE H.23.		HIGHLY PATHOGENIC AGENTS			27
ARTICLE H.24.		HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391			27
PART II - CONTRACT CLAUSES					28
SECTION I - CONTRACT CLAUSES					28
ARTICLE I.1.		GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT			28
ARTICLE I.2.		AUTHORIZED SUBSTITUTION OF CLAUSES			32
ARTICLE I.3.		ADDITIONAL CONTRACT CLAUSES			33
ARTICLE I.4.		ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT			34
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS					35
SECTION B - LIST OF ATTACHMENTS					35
PART IV - REPRESENTATIONS AND INSTRUCTIONS					36
SECTION K - REPRESENTATIONS AND CERTIFICATIONS					36

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- ii -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The overall objective for this contract with Enanta Pharmaceuticals will develop EDP-788, a prodrug of EDP- 322 with enhanced bioavailability and water solubility, for oral and intravenous administration. Then move EDP-788 from preclinical to clinical development and toward licensure for use as a medical countermeasure for anthrax, plague and tularemia.

ARTICLE B.2. ESTIMATED COST - OPTION

 

a.

The estimated cost of the Base Period of this contract is $14,315,157.

 

b.

Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

 

c.

If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government’s total estimated contract amount represented by the sum of the estimated cost will be increased as follows:

 

Estimated Cost
Base Period		$	14,315,157
Option 1		$	1,922,683
Option 2		$	7,296,268
Option 3		$	3,143,236
Option 4		$	10,183,163
Option 5		$	827,085
Option 6		$	5,057,348
Total (Base and Options)		$	42,744,940

ARTICLE B.3. ADVANCE UNDERSTANDINGS

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

 

a.

Establishment of Indirect Cost Rate

Indirect costs are funded at a rate of 75% of Base Costs which includes: Direct Salaries and wages excluding vacation pay, Fringe Benefits, Subcontractors, Consultants, Travel, and Other Direct Costs; however, the Contractor shall not bill or be reimbursed for indirect costs until such time as an indirect cost proposal has been submitted to the cognizant office responsible for negotiating the indirect cost rates, unless a temporary billing rate(s) has been included herein. Unless otherwise specified below, the indirect cost rate proposal shall be submitted no later than three (3) months after the date of contract award.

The Contractor may bill indirect costs at a temporary billing rate of 75% of Base Costs which includes: Direct Salaries and wages excluding vacation pay, Fringe Benefits, Subcontractors, Consultants, Travel, and Other Direct Costs as authorized by the Contracting Officer; until such time as indirect costs have been established.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 1 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

b.

Subcontract

A Cost and Reimbursement type subcontract with the following subcontractors for the base award and option(s) specified in the Statement of Work not to exceed the following amounts provided in direct performance of this contract:

 

SUBCONTRACT #

Base Period

Option1

Option 2

Option 3

Option 4

Option 5

Option 6

TOTAL per Subcontractor

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

TOTAL

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

[*****]

 

c.

Advance Copies of Press Releases

The contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. In accordance with NIH Manual Chapter 1754, misrepresenting contract results or releasing information that is injurious to the integrity of NIH may be construed as improper conduct. The complete text of NIH Manual Chapter 1754 can be found at: http://www1.od.nih.gov/oma/manualchapters/management/1754/

Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer’s Technical Representative (COTR) has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release.

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

 

a.

Items Unallowable Unless Otherwise Provided

Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, 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.

Foreign travel;

 

6.

Consultant costs;

 

7.

Subcontracts;

 

8.

Patient care costs;

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 2 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

9.

Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more and “sensitive items” (defined as items of personal property (supplies and equipment that are highly desirable and easily converted to person use), regardless of acquisition value.

 

b.

Travel Costs

 

1.

Domestic Travel

Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract base period and all options shall not exceed the amount listed for its respective base and option period listed below without the prior written approval of the Contracting Officer.

 

Domestic Travel Costs
Base Period		$	26,000
Option 1		$	12,000
Option 2		$	10,000
Option 3		$	12,000
Option 4		$	14,000
Option 5		$	0
Option 6		$	10,000
Total of Base and All Option(s)		$	84,000

 

2.

The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.2 - Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 3 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

 

a.

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, dated September 13, 2011, set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under “Helpful Resources.”

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

 

a.

Technical Reports

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES Article in SECTION F of this contract:

[Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

 

1.

Monthly Progress Report

This report shall include a description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

 

2.

Annual Progress Report

This report shall include a summation of the results of the entire contract work for the period covered. An annual report will not be required for the period when the Final Report is due. A Monthly Report shall not be submitted when an Annual Report is due.

 

3.

Annual Technical Progress Report for Clinical Research Study Populations

PopulationsIn addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website:

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 4 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

Include a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender and race/ethnicity.

 

4.

Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. A/An Annual report will not be required for the period when the Final Report is due.

 

5.

Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

 

6.

Report on Select Agents or Toxins and/or Highly Pathogenic Agents

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each Annual Progress Report:

 

1.

Any changes in the use of the Select Agent or Toxin including initiation of “restricted experiments,” and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

 

2.

If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

 

a.

A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

 

b.

A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html) or listed on the U.S. National Select Agents Registry restricted experiments website (http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html);

 

c.

The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

 

d.

For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 5 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Annual Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Annual Progress Report.

 

b.

Other Reports/Deliverables

 

1.

Decision Gate Report

A Decision Gate Report shall be submitted when the Contractor has completed a stage of product development and has reached a Go/No Go decision point, as defined in the approved Strategic Staged Product Development Plan. These reports shall be in sufficient detail to explain comprehensively the results achieved. The description shall also include pertinent data and/or conclusions resulting from the analysis and scientific evaluation of data accumulated to date under the project.

Decision Gate Reports shall include the following specific information:

a) Cover page that lists the contract number and title, the period of performance being reported, the Contractor’s name and address, telephone number, fax number, email address, and the date of submission.

b) An introduction covering the purpose and scope of the contract effort, and the specific Decision Gate that has been reached.

c) Document and summarize the results of work undertaken that supports the completion of the stage of product development, including an analysis of the data as it relates to the qualitative and quantitative criteria established for Go/No Go decision-making.

d) Actual costs incurred in relation to costs estimated in the original approved budget.

e) A description of the next stage of product development to be initiated and a request for COTR’s approval to proceed to the next stage of product development.

 

2.

Decision Gate and Work Plan Change Request

The Contractor shall submit a written request any changes in the approved Strategic Staged Product Development Plan and Work Plan. This request shall include the following:

a) A discussion of the justification/rationale for the request based on current data and a description of those data.

b) Options for addressing the needed change/deviation from the approved timelines and/or decision gates, including a cost-benefit analysis of each option.

c) A recommendation for the preferred option that includes a full analysis and discussion of the effects of the change on the entire product development program, timelines, and budget.

 

3.

Draft and Final Clinical Trial Protocols

The NIAID has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in NIAID-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 draft protocols for review and all final protocols and protocol amendments for approval by the COTR. The consultative review period for submission of draft protocols will be negotiated with the COTR. The review period of final protocols will be negotiated with the COTR and must occur prior to FDA submission and enrollment. An additional review and approval period may be required for changes in the final protocol. Three (3) weeks should be planned for each review period. It is

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 6 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

recommended that protocols be submitted using the approved DMID template and include a sample Informed Consent and Clinical Trials Monitoring Plan. The DMID templates and other important information regarding performing human subject research are available at http://www3.niaid.nih.gov/research/resources/DMIDClinRsrch/.

 

4.

Strategic Staged Product Development Plan and Work Plan

The Contractor shall all correspondence from the FDA and shall prepare and submit minutes of all meetings with the FDA in accordance with Article F.2. Deliveries. At any time during the contract period the COTR may request additional detail from the Contractor regarding the Strategic Staged Product Development Plan and the Work Plan.

 

5.

External Advisory Group Approval Request

The Contractor shall submit the following to the COTR and the Contracting Officer to request approval of External Advisory Group membership:

a) A brief biosketch for each member being proposed.

b) A description of the roles and duties of each member.

c) The proposed compensation for each member.

The Contractor shall plan to have the External Advisory Group consulting agreements in place within six months of the effective date of the contract.

 

6.

Contract Meeting Reports

A report of the Post-Award Contract Initiation Meeting, Annual Review Meetings and External Advisory Group meetings shall be prepared by the Contractor and submitted in accordance with F.2. Deliveries. These reports shall include the slide presentations and all other meeting materials as well as summaries of all discussions.

 

7.

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 COTR.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301 ###-###-####). 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.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 7 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Office of Acquisition

6700-B Rockledge Drive

MSC 7612, Room 3214

Bethesda, Maryland 20892-7612

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed “Interagency Edison,” an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 8 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

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.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 9 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

SECTION E - INSPECTION AND ACCEPTANCE

 

a.

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

 

b.

For the purpose of this SECTION, the COTR is the authorized representative of the Contracting Officer.

 

c.

Inspection and acceptance will be performed at:

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Division of Microbiology and Infectious Diseases

Office of Biodefense Research Affairs

Drug Development Section

6610 Rockledge Drive, Room 3610

Bethesda, Maryland 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

 

d.

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 10 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

 

a.

The period of performance of this contract shall be from September 30, 2011 through March 30, 2014.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

 

a.

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984):

 

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 11 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

 

b.

The items below are deliverables specific to the base award and each option:

 

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 12 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

 

c.

The above items shall be addressed and delivered to:

Contracting Officer’s Technical Representative (COTR)

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Division of Microbiology and Infectious Diseases

Office of Biodefense Research Affairs

Drug Development Section

6610 Rockledge Drive, Room 3610

Bethesda, Maryland 20892

and

Contracting Officer (CO)

Microbiology and Infectious Diseases Research Contracts Branch A

Office of Acquisitions, DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 13 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE: 52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 14 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

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:

Helen F. Schiltz Ph.D.

Office of Biodefense Research Affairs

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 alternate COTR is responsible for carrying out the duties of the COTR only in the event that the COTR can no longer perform his/her duties as assigned or is officially covering for the COTR when they are on scheduled leave.

The alternate COTR for the purpose of this contract is:

Ping Chen Ph.D.

Office of Biodefense Research Affairs

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COTR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (JANUARY 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

 

Name		Title
Ly Phan Ph.D.		Principal Investigator

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 15 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

a.

Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

 

1.

Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

 

a.

The original invoice shall be submitted to the following designated billing office:

National Institutes of Health

Office of Financial Management

Commercial Accounts

2115 East Jefferson Street, Room 4B-432, MSC 8500

Bethesda, MD 20892-8500

 

b.

One copy of the invoice shall be submitted to the following approving official:

Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases

Office of Acquisitions, DEA Room 3214

6700-B Rockledge Drive MSC 7612

Bethesda, Maryland 20892-7612

E-Mail: ***@***

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor’s name, contract number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a “proper invoice.”]

 

2.

In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

 

a.

Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIAID.

 

b.

Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAIDOAInvoices.

 

c.

Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 16 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

d.

DUNS or DUNS+4 Number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

 

e.

Invoice Matching Option. This contract requires a two-way match.

 

f.

Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

 

b.

Inquiries regarding payment of invoices shall be directed to the designated billing office, (301)  ###-###-####.

 

c.

The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

“I hereby certify that the salaries charged in this invoice are in compliance with the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract.”

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.5. 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, interim evaluation(s) will be prepared on the anniversary date of the contract.

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

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

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 17 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

b.

Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.csd.disa.mil

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 18 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(B) (JANUARY 2006)

 

a.

The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

 

b.

The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

 

c.

If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Human Subject Assurances.

(End of clause)

ARTICLE H.2. HUMAN SUBJECTS

Research involving human subjects shall not be conducted under this contract until the protocol developed in Phase I has been approved by NIAID, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the Contracting Officer a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the protocol. The human subject certification can be met by submission of the Contractor’s 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).

When research involving Human Subjects will take place at collaborating sites or other performance sites, the Contractor shall obtain, and keep on file, a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the research.

ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 19 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

The Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

http://grants.nih.gov/grants/guide/notice-files/not99-107.html

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

The Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract.

Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan.

The Data and Safety Monitoring Board shall be established and approved prior to beginning the conduct of the clinical trial.

ARTICLE H.5. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV

The Food and Drug Administration Amendments Act of 2007 (FDAAA) at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf, Title VIII, expands the National Institutes of Health’s (NIH’s) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to specified “applicable clinical trials,” including those supported in whole or in part by NIH funds. FDAAA requires:

 

•

the registration of certain “applicable clinical trials” (see Definitions at: http://grants.nih.gov/ClinicalTrials_fdaaa/definitions.htm) in ClinicalTrials.gov no later than 21 days after the first subject is enrolled; and

 

•

the reporting of summary results information (including adverse events) no later than 1 year after the completion date (See Definitions at link above) for registered applicable clinical trials involving drugs that are approved under section 505 of the Food, Drug and Cosmetic Act (FDCA) or licensed under section 351 of the PHS Act, biologics, or of devices that are cleared under section 510k of FDCA.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 20 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

In addition, the Contractor shall notify the Contracting Officer’s Technical Representative (COTR), with the trial registration number (NCT number), once the registration is accomplished. This notification may be included in the Technical Progress Report covering the period in which registration occurred, or as a stand alone notification.

The Contractor is the Sponsor, therefore the “Responsible Party” for the purposes of compliance with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this contract in the Government database, ClinicalTrials.gov (http://www.ClinicalTrials.gov).

Additional information is available at: http://prsinfo.clinicaltrials.gov.

ARTICLE H.6. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self designated form, provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310).

ARTICLE H.7. SALARY RATE LIMITATION, HHSAR 352.231-70 (JANUARY 2010)

 

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 I in effect on the date an expense is incurred.

 

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 Federal 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.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 21 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

(End of clause)

See the following Web site for Executive Schedule rates of pay: http://www.opm.gov/oca/.

(For current year rates, click on Salaries and Wages / Executive Schedule / Rates of Pay for the Executive Schedule. For prior year rates, click on Salaries and Wages / select Another Year at the top of the page / Executive Schedule / Rates of Pay for the Executive Schedule. Rates are effective January 1 of each calendar year unless otherwise noted.)

ARTICLE H.8. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine’s (NLM) PubMed Central (PMC) an electronic version of the author’s final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author’s final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html.

ARTICLE H.9. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to distribute any needle or syringe for the purpose of preventing the spread of blood borne pathogens in any location that has been determined by the local public health or local law enforcement authorities to be inappropriate for such distribution.

ARTICLE H.10. PRESS RELEASES

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.11. RESTRICTION ON ABORTIONS

The Contractor shall not use contract funds for any abortion.

ARTICLE H.12. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human embryo or embryos” includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 22 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

ARTICLE H.13. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION

The Contractor shall not use contract funds to disseminate scientific information that is deliberately false or misleading.

ARTICLE H.14. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

The Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

“(3) Definition of unauthorized alien. - As used in this section, the term ‘unauthorized alien’ means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.”

ARTICLE H.15. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(B) (OCTOBER 2009)

 

a.

Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

 

b.

The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

 

c.

The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

 

d.

If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail: ***@***; Web site: (http://www.aphis.usda.gov/animal_welfare).

(End of Clause)

ARTICLE H.16. ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 23 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor’s technical proposal, as modified in the Final Proposal Revision (FPR), dated September 23, 2011, which is incorporated by reference.

ARTICLE H.17. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-6, Option for Increased Quantity set forth in ARTICLE I.3. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 30 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 Article in SECTION B of this contract.

ARTICLE H.18. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS

The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that investigators (defined as the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded under NIH contracts) will not be biased by any conflicting financial interest. For the purposes of this part relating to financial interests, “Investigator” includes the Investigator’s spouse and dependent children. 45 CFR Part 94 is available at the following Web site:

http://ecfr.gpoaccess.gov/cgi/t/text/textidx? c=ecfr;sid=cfc3d0caac2d06e14935ada5731b763d;rgn=div5;view=text;node=45%3A1.0.1.1.52;idno=45;cc=ecfr

As required by 45 CFR Part 94, the Contractor shall, at a minimum:

 

a.

Maintain a written, enforceable policy on conflict of interest that complies with 45 CFR Part 94 and inform each investigator of the policy, the investigator’s reporting responsibilities, and the applicable regulations. The Contractor must take reasonable steps to ensure that investigators working as collaborators or subcontractors comply with the regulations.

 

b.

Designate an official(s) to solicit and review financial disclosure statements from each investigator participating in NIH-funded research. Based on established guidelines consistent with the regulations, the designated official(s) must determine whether a conflict of interest exists, and if so, determine what actions should be taken to manage, reduce, or eliminate such conflict. A conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. The Contractor may require the management of other conflicting financial interests in addition to those described in this paragraph, as it deems appropriate. Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interests are included in 45 CFR Part 94, under Management of Conflicting Interests.

 

c.

Require all financial disclosures to be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

 

d.

Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the Contractor with respect to each conflicting interest 3 years after final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

 

e.

Establish adequate enforcement mechanisms and provide for sanctions where appropriate.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 24 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

If a conflict of interest is identified, the Contractor shall report to the Contracting Officer, the existence of the conflicting interest found. This report shall be made and the conflicting interest managed, reduced, or eliminated, at least on a temporary basis, within sixty (60) days of that identification.

If the failure of an investigator to comply with the conflict of interest policy has biased the design, conduct, or reporting of the NIH-funded research, the Contractor must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will take appropriate action or refer the matter to the Contractor for further action, which may include directions to the Contractor on how to maintain appropriate objectivity in the funded research.

The Contracting Officer may at any time inquire into the Contractor’s procedures and actions regarding conflicts of interests in NIH-funded research, including a review of all records pertinent to compliance with 45 CFR Part 94. The Contracting Officer may require submission of the records or review them on site. On the basis of this review, the Contracting Officer may decide that a particular conflict of interest will bias the objectivity of the NIH-funded research to such an extent that further corrective action is needed or that the Contractor has not managed, reduced, or eliminated the conflict of interest. The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

If the Contracting Officer determines that NIH-funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an investigator with a conflict of interest that was not disclosed or managed, the Contractor must require disclosure of the conflict of interest in each public presentation of the results of the research.

ARTICLE H.19. PUBLICATION AND PUBLICITY

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, the Contractor shall acknowledge the support of the National Institutes of Health whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

“This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201100029C”

ARTICLE H.20. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1 ###-###-####). All telephone calls will be handled confidentially. The e-mail address is ***@*** and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

ARTICLE H.21. SHARING RESEARCH DATA

[The data sharing plan submitted by the Contractor is acceptable/The Contractor’s data sharing plan, dated September 13, 2011 is hereby incorporated by reference.] The Contractor agrees to adhere to its plan and shall request prior approval of the Contracting Officer for any changes in its plan.

The NIH endorses the sharing of final research data to serve health. this contract is expected to generate research data that must be shared with the public and other researchers. NIH’s data sharing policy may be found at the following Web site:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 25 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/). The rights and privacy of people who participate in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects.

ARTICLE H.22. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

The work being conducted under this contract may involve the possession, use, or transfer of a select agent or toxin. The contractor shall not conduct work involving a Select Agent or Toxin under this contract until it and any associated subcontractor(s) comply with the following:

For prime or subcontract awards to domestic institutions that possess, use, and/or transfer a Select Agent or Toxin under this contract, the institution must comply with the provisions of 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 (http://www.selectagents.gov/Regulations.html) as required, before using NIH funds for work involving a Select Agent or Toxin. No NIH funds can be used for research involving a Select Agent or Toxin at a domestic institution without a valid registration certificate.

For prime or subcontract awards to foreign institutions that possess, use, and/or transfer a Select Agent or Toxin, before using NIH funds for any work directly involving a Select Agent or Toxin, the foreign institution must provide information satisfactory to the NIAID that safety, security, and training standards equivalent to those described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be administered on behalf of all Select Agent or Toxin work supported by these funds. The process for making this determination includes a site visit to the foreign laboratory facility by an NIAID representative. During this visit, the foreign institution must provide the following information: concise summaries of safety, security, and training plans; names of individuals at the foreign institution who will have access to the Select Agent or Toxin and procedures for ensuring that only approved and appropriate individuals, in accordance with institution procedures, will have access to the Select Agents or Toxins under the contract; and copies of or links to any applicable laws, regulations, policies, and procedures applicable to that institution for the safe and secure possession, use, and/ or transfer of select agents. Site visits to foreign laboratories are conducted every three years after the initial review. No NIH funds can be used for work involving a Select Agent or Toxin at a foreign institution without written approval from the Contracting Officer.

Prior to conducting a restricted experiment with a Select Agent or Toxin under this contract or any associated subcontract, the contractor must discuss the experiment with the Contracting Officer’s Technical Representative (COTR) and request and obtain written approval from the Contracting Officer. Domestic institutions must submit to the Contracting Officer written approval from the CDC to perform the proposed restricted experiment. Foreign institutions require review by a NIAID representative. The prime contractor must contact the COTR and the NIAID Office of International Extramural Activities (OIEA) at mailto ***@*** for guidance on the process used by NIAID to review proposed restricted experiments. The NIAID website provides an overview of the review process at http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/saconproc.aspx. The Contracting Officer will notify the prime contractor when the process is complete. No NIH funds can be used for a restricted experiment with a Select Agent or Toxin at either a domestic or foreign institution without written approval from the Contracting Officer.

Listings of HHS and USDA select agents and toxins, and overlap select agents or toxins as well as information about the registration process for domestic institutions, are available on the Select Agent Program Web site at http://www.selectagents.gov/ and http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.

For foreign institutions, see the NIAID Select Agent Award information:

(http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/default.aspx).

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 26 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

ARTICLE H.23. HIGHLY PATHOGENIC AGENTS

The work being conducted under this contract may involve a Highly Pathogenic Agent (HPA). The NIAID defines an HPA as a pathogen that, under any circumstances, warrants a biocontainment safety level of BSL3 or higher according to either:

 

1.

The current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)(http:// www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm);

 

2.

The Contractor’s Institutional Biosafety Committee (IBC) or equivalent body; or

 

3.

The Contractor’s appropriate designated institutional biosafety official.

If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an IBC or equivalent body, or institutional biosafety official, the highest recommended containment level must be used.

ARTICLE H.24. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting, convention, conference or training seminar that is conducted in, or that otherwise uses the rooms, facilities, or services of a place of public accommodation that do not meet the requirements of the fire prevention and control guidelines as described in the Public Law. This restriction applies to public accommodations both foreign and domestic.

Public accommodations that meet the requirements can be accessed at: http://www.usfa.fema.gov/hotel/index.htm.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 27 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at: https://www.acquisition.gov/far/. HHSAR Clauses at: http:// www.hhs.gov/policies/hhsar/subpart352.html.

 

a.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 28 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 29 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

 

b.

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 30 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 08/2011].

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 31 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

ARTICLE I.1. of this SECTION is hereby modified as follows:

 

a.

THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 32 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

This contract incorporates the following clauses by reference, with the same force and effect, as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

 

a.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

1.

FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (April 2010).

 

2.

FAR Clause 52.203-14, Display of Hotline Poster(s) (December 2007).

“….(3) Any required posters may be obtained as follows:

 

Poster(s)		Obtain From”
HHS Contractor Code of Ethics and Business Conduct Poster		http://oig.hhs.gov/fraud/hotline/ OIG Hotline Poster.pdf

 

3.

FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

 

4.

FAR Clause 52.217-6, Option for Increased Quantity (March 1989).

“….The Contracting Officer may exercise the option by written notice to the Contractor any point prior to 30 days of the completion date of the contract ….”

 

5.

FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (January 2011).

“(c) Waiver of evaluation preference

[ ] Offeror elects to waive the evaluation preference.”

 

6.

FAR Clause 52.227-16, Additional Data Requirements (June 1987).

 

7.

FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001).

 

8.

FAR Clause 52.251-1, Government Supply Sources (August 2010).

 

b.

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:

 

1.

HHSAR Clause 352.201-70, Paperwork Reduction Act (January 2006).

 

2.

HHSAR Clause 352.223-70, Safety and Health (January 2006).

 

3.

HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to Persons with Disabilities (January 2001).

 

c.

NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:

The following clauses are attached and made a part of this contract:

 

1.

NIH(RC)-11, Research Patient Care Costs (4/1/84).

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 33 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

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 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (January 2011)

(a) The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the Central Contractor Registration database at http://www.ccr.gov.

(b)(1) The Contractor will receive notification when the Government posts new information to the Contractor’s record.

(2) The Contractor will have an opportunity to post comments regarding information that has been posted by the Government. The comments will be retained as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

(3) (i) Public requests for system information prior to April 15, 2011, will be handled under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

(ii) As required by section 3010 of Public Law 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available.

(End of clause)

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 34 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION B - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

1. Statement of Work

Statement of Work, dated September 13, 2011, 3 pages.

2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4

Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (8/08), 6 pages.

3. Inclusion Enrollment Report

Inclusion Enrollment Report, PHS 398/2590, (Rev. 6/09), 1 page. Located at: http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf

4. Inclusion Table

Inclusion Table (Formerly Annual Technical Progress Report Format for Each Study), April, 1998, 1 page. Located at: http://grants.nih.gov/grants/funding/women_min/InclusionOld_Form.pdf

5. Safety and Health

Safety and Health, HHSAR Clause 352.223-70, (1/06), 1 page.

6. Research Patient Care Costs

Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.

7. Disclosure of Lobbying Activities, SF-LLL

Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages.

8. Conference Expense Offset Worksheets

Contractor Pre-Conference Expense Offset Worksheet, dated 3/2008, 1 page. Located at:http://rcb.cancer.gov/rcb-internet/forms/Pre-Conf-worksheet.pdf

Post Conference Expense Offset Worksheet, dated 3/2008, 2 pages. Located at: http://rcb.cancer.gov/rcb-internet/forms/Post-Conf-worksheet.pdf

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 35 -

---

Contract Number: HHSN272201100029C

Reference Number: NIHAI2010097

 

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. [This includes the changes identified in paragraph (b) of the FAR provision 52.204-8, Annual Representations and Certifications, contained in the Contractor’s proposal.]

 

2.

NIH Representations & Certifications, dated September 20, 2011

 

3.

Human Subjects Assurance Identification Number. Enanta Pharmaceuticals will conduct clinical trials in human subjects under their subcontract agreement with PPD in this contract. PPD’s Human Subjects Assurance Identification Number is FWA00003916.

 

4.

Animal Welfare Assurance Number Animal Welfare Assurance Number. Enanta Pharmaceuticals will conduct work involving vertebrate animals under their subcontract agreement with MPI in this contract. MPI’s Animal Welfare Assurance Numbers is A3181?01.

NOTE: Restriction- Funds included in this award for research involving live vertebrate animals are restricted and may not be used for any other purpose without the written prior approval of the NIH awarding component. Under governing PHS Policy no funds may be drawn down from the payment system and no obligations made against federal funds for research involving live vertebrate animals prior to approval by the Office of Laboratory Animal Welfare (OLAW) of an Animal Welfare Assurance in accordance with the PHS Policy on Humane Care and Use of Laboratory Animals. This restriction applies to the applicant organization and all performance sites (e.g., collaborating institutions, sub-contractors, sub-grantees) lacking OLAW-approved Assurances, whether domestic, foreign or inter-institutional. If the applicant organization does not have an Animal Welfare Assurance and the animal work will be conducted at an institution with an Assurance, the grantee must obtain an Inter-institutional Assurance from OLAW. Animal Welfare Assurances must be submitted to OLAW not later than November 30, 2011. Failure to submit the Animal Welfare Assurance to OLAW within the required timeframe or to otherwise comply with the above requirements can result in suspension and/or termination of this award, withholding of support, audit disallowances, and/or other appropriate action.

END of the SCHEDULE

(CONTRACT)

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 36 -

---

Final Proposal (Revision #4) – 9/13/2011		ENANTA Pharmaceuticals, Inc

 

CHANGES IN THE FINAL BUSINESS PROPOSAL (Revision #4, September 13, 2011)

(RFP): BAA-NIAID-DMID-NIHAI2010097

“Development of Therapeutics for Biodefense”

The following items in the table below summarizes the major changes to the Business Proposal Revision #3 dated September 1, 2011, with the corresponding page numbers in the current Final Proposal (Revision #4), as per the teleconference discussion on September 12th.

 

Changes		Major Changes		Comment		Page #
1.		Revised Business Proposal Cover Sheet		•       Reflect change to total amount requested (reduced $119,000) due to deletion of the budget for the Safety Monitoring Committee reports in Options 2 and 5 as per NIAID’s request		1
2.		Revised Pricing Proposal Signature Page		•       Reflect change to total amount requested (reduced $119,000)		2
3.		Revised Proposal Summary and Data Record Page		•       Reflect change to estimated direct costs requested (reduced $68,000)		3
4.		Revised Detailed budget for Enanta		Revised to reflect requested changes to Options 2 and 5; removed funds for Safety Monitoring Committee; reclassified Materials & Supplies, Consultants’ travel, External Advisory Board fees and travel, Vendor Costs, and Subcontractor Costs as per NIAID’s request		6-25
5.		Revised Budget Justification		Revised to reflect requested changes to Enanta’s Detailed Budget		67-70

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 37 -

---

Final Proposal (Revision #4) – 9/13/2011		ENANTA Pharmaceuticals, Inc

 

BAA contract structure

Base period and 6 options for the 5-year award.

Contractor: Enanta Pharmaceuticals, Inc.

Title: BAA NIAID-DMID-NIHAI2010097 “Development of Therapeutics for Biodefense”

Total award amount: $42,744,940

Award period: 9/30/2011 – 9/29/2016

Non-severable tasks within the Base period

Duration (months): 30 months

Budget: $ 14,315,157

The major focus of the R&D activities conducted in the base period is:

 

•

Microbiology

 

•

Non-GLP and GLP IND enabling safety studies

 

•

Medicinal chemistry for back up candidate (if needed)

 

•

Non-GMP and cGMP manufacturing of the active pharmaceutical ingredient (API), formulation, and manufacturing of oral drug product

 

•

Long term stability studies of API and drug product

 

•

Clinical protocol development for oral studies, oral IND preparation, review and submission

The molecule is expected to be safe and active against B. anthracis, F. tularensis, Y. pestis, MRSA and streptococci.

Decision Gate Criteria: Successful completion of oral IND enabling safety studies and manufacturing of non-GMP and cGMP API and oral drug product, formulation and stability studies, protocol development, IND preparation and submission.

Deliverables: Monthly and annual technical progress reports, Decision Gate Report, other study reports as needed.

Non-severable tasks within Option Period 1

Duration (months): 10 months

Budget: $ 1,922,683

Activities during the Option Period 1 will include:

 

•

IV preclinical PKs and non-GLP IV safety studies

 

•

IV clinical formulation development

Decision Gate Criteria: Successful completion of IV preclinical non-GLP PKs and safety studies and completion of IV formulation development.

Deliverables: Monthly and annual technical progress reports, Decision Gate report, and other study reports as needed.

Criteria for Exercising Option: Successful completion of oral IND enabling safety studies with adequate safety margin (in Base period).

Non-severable tasks within Option Period 2

Duration (months): 18 months

Budget: $ 7,296,268

Activities during the Option Period 2 will include:

 

•

Oral clinical Phase 1a SAD and 1b MAD studies

 

•

Oral human BAL lung distribution study

Decision Gate Criteria: Successful completion of oral clinical Phase 1a SAD, Phase 1b MAD and oral human BAL lung distribution studies.

Deliverables: Monthly and annual technical progress reports, clinical study reports, other study and audit reports as needed, and FDA communications.

Criteria for Exercising Option: Successful completion of oral IND enabling safety studies with adequate safety margin (in Base period).

Non-severable tasks within Option Period 3

Duration (months): 15 months

Budget: $ 3,143,236

Activities during the Option Period 3 will include:

 

•

IV GLP IND enabling safety studies

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 38 -

---

Final Proposal (Revision #4) – 9/13/2011		ENANTA Pharmaceuticals, Inc

 

•

IV clinical protocol development

 

•

IV IND preparation and reviews

Milestone: Successful completion of IV GLP IND enabling safety studies, IV clinical protocol development and IV IND preparation and reviews.

Deliverables: Monthly and annual technical progress reports, and other study reports as needed.

Criteria for Exercising Option: Successful completion of IV range finding safety studies with adequate safety margin (in Option 1)

Non-severable tasks within Option Period 4

Duration (months): 34 months

Budget: $ 10,183,163

Activities during the Option Period 4 will include:

 

•

Humanization of NHP PK

 

•

Discussion with the FDA regarding NHP efficacy studies with select agents for biodefense indications

 

•

NHP efficacy studies for biodefense pathogens

Decision Gate Criteria: Successful completion NHP efficacy studies and demonstration of efficacy against one or more biodefense pathogens.

Deliverables: Monthly and annual technical progress reports, FDA communication, and efficacy study reports.

Criteria for Exercising Option: 1) Demonstrate efficacy in small animal models (mice, rats or rabbits) for biodefense pathogens (in Base period). 2) Demonstrate adequate safety and tolerability in oral Phase 1a/1b studies (in Option 2)

Non-severable tasks within Option Period 5

Duration (months): 27 months

Budget: $ 827,085

Activities during the Option Period 5 will include:

 

•

IV drug product manufacturing

 

•

24 months drug product stability study

 

•

Submission of IV IND application to the FDA

Decision Gate Criteria: Successful completion of IV drug product manufacturing, IV IND submission and drug product stability.

Deliverables: Monthly and annual technical progress reports, FDA communication, and study reports.

Criteria for Exercising Option: Successful completion of IV IND enabling safety studies with adequate safety margin (in Option 3)

Non-severable tasks within Option Period 6

Duration (months): 12 months

Budget: $ 5,057,348

Activities during the Option Period 6 will include:

 

•

V clinical Phase 1a SAD and 1b MAD studies

Decision Gate Criteria: Successful completion of IV Phase 1a SAD and 1b MAD studies

Deliverables: Monthly and annual technical progress reports, FDA communications, and clinical study reports (Note: Clinical study report (CSR) for Phase 1b will not be available until 2 months after the end of the funding period [No Cost Extension will be required] due to the NIAID requested delay in starting the IV clinical studies, to be initiated in Year 5).

Criteria for Exercising Option: Successful completion of IV IND enabling safety studies with adequate safety margin (in Option 3).

 

Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission.

- 39 -