AWARD/CONTRACT

 

Exhibit 4.51

Confidential treatment has been requested for certain portions of this exhibit. The copy filed herewith omits the information subject to the confidential treatment request. Omissions are designated as “ ***** ”. A complete version of this exhibit has been filed separately with the Commission pursuant to an application for confidential treatment under Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended.

ADB No. N01-AI-40071

 

 

 

 

 

 

 

16. TABLE OF CONTENTS

CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

 

 

 

 

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

DETAILED TABLE OF CONTRACT CONTENTS

2

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

3

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

SECTION B — SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to manufacture, fill, finish, and release 500,000 doses of a Modified Vaccinia Ankara (MV A) vaccine, with an option for an additional 2.5 million doses, from at least two additional cGMP consistency lots within the first two years of award. The vaccine shall be of a quality suitable for a path to licensure in the U.S. The third year of the contract will allow for preclinical study and clinical trial follow-up, maintenance and storage of the vaccine inventory, and stability testing.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

a.		The estimated cost of the Base portion of this contract is $*****.
b.		The fixed fee for the Base portion of this contract is $*****. The fixed fee shall be paid in instalments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE 1.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.
c.		The Government’s obligation, represented by the sum of the estimated cost plus the fixed fee for the Base portion of this contract $76,283,309.
d.		If the Government exercises its option pursuant to ARTICLE H.10. of this contract, the Government’s total obligation represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

 

 

e.

Total funds currently available for payment and allotted to this contract are *****, of which ***** represents the estimated costs, and of which ***** represents the fixed fee. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE 1.2. Authorized Substitutions of Clauses.

 

f.

It is estimated that the amount currently allotted will cover performance of the contract through September 29, 2005.

 

g.

The Contracting Officer may allot additional funds to the contract without the concurrence of the Contractor.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

a.		Items Unallowable Unless Otherwise Provided
		Notwithstanding the clauses, ALLOW ABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

4

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

 

(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)		Consultant costs;
(6)		Subcontracts;
(7)		Patient care costs;
(8)		Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined and listed in the Contractor’s Guide for Control of Government Property), 1990, regardless of acquisition value.
b.		Travel Costs
(1)		Domestic Travel

 

	(a)		Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed ***** without the prior written approval of the Contracting Officer.
	(b)		The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

 

(2)

Foreign Travel

 

	(a)		Total expenditures for foreign travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed ***** without the prior written approval of the Contracting Officer.
	(b)		The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

a.

Subcontract

To negotiate a firm fixed price/cost reimbursement type subcontract with Baxter Healthcare SA to develop, formulate, purify, document and qualify appropriate downstream processing and other necessary procedures and Quality Control testing, in process testing, and stability testing for a MV A vaccine. The subcontractor shall document the process to manufacture MV A vaccine and manufacture, fill, and finish, and deliver 500,000 doses with an option for an additional 2.5 million doses and other items set forth in Section B of the subcontract agreement. The amount shall not exceed ***** for the Base period (Milestones 1-11, 15-18) and ***** for the Option (Milestones 12-14) for a Total Amount of *****.

5

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

b.

Subcontract

Funds in the amount of ***** for the Base period (Milestones I-II, 15-18) and ***** for the Option (Milestones 12-14) for a Total Amount of ***** are set aside for anticipated fixed price or cost reimbursement type subcontracts with various organizations. Award of each subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation as required by the Subcontracts clause of the General Clauses incorporated in this contract. A draft subcontract shall be submitted for review by the Contracting Officer. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

c.

Consultants

Consultant fees to be paid to the following individuals:

*		Plus Travel
**		Plus expenses

 

d.

Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

e.

Contract Number Designation

On all correspondence submitted under this contract, the contractor agrees to clearly identify the two contract numbers that appear on the face page of the contract as follows:

Contract No. HHSN26620040007lC ADB Contract No. NOl-AI-4007l

 

f.

Protocol Approval

The Contractor shall not commence any activity or work as described in any animal or clinical protocol unless the Contractor has received written approval of that activity or work from the NIAID Project Officer. The NIAID Project Officer will approve the protocol in consultation with an advisory group. It is understood that the protocol may be modified and may not be implemented as proposed. It is further understood that any costs incurred in the conduct of any animal or

6

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

clinical protocol that has not received the written approval of the NIAID Project Officer shall not be reimbursed through this contract.

g.

Clinical Exemption Committee

The Contractor shall not commence work on any protocol until the NIAID has informed the Contractor that it has been found exempt from OMB clearance procedures by the Clinical Exemption Committee of the NIH.

h.

Indirect Rate Agreement

The Contractor proposed rates of Fringe: *****; Overhead: ***** (Cambridge) and ***** (Canton); and G&A: ***** were used for negotiation purposes. Documentation supporting these rates shall be provided to the Division of Financial Advisory Services, NIH, at the address set forth in Article GA. within six months of award. Failure to provide this documentation shall result in suspension of indirect cost reimbursement until a formal rate agreement has been executed.

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, SECTION J, ATTACHMENT I, dated September 30,2004, attached hereto and made apart of this contract.

ARTICLE C.2. REPORTING REQUIREMENTS

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 ARTICLE F.1. DELIVERIES of this contract:

a.

Technical Reports

 

1.

Monthly Technical Progress Reports On the fifteenth of each month for the previous calendar month, the Contractor shall submit three (3) copies of a Monthly Technical Progress Report, comprising two (2) copies to the Project Officer and one (I) copy to the Contracting Officer. Such reports shall include the following specific information:

 

	a.		A cover page that lists the contract number and title, the period of performance being reported, the contractor’s names and address, the author(s), and the date of submission;
	b.		SECTION I-A listing of any and all deliverables submitted during the previous month, a listing of any and all relevant administrative items occurring in the previous months, a listing of all meetings held and meeting minutes submitted during the previous month, a brief summary of financial status of the Contract, and an introduction covering the purpose and scope of the contract effort;
	c.		SECTION II-The report shall detail, document, and summarize the results of work done during the period covered and shall be organized by Milestones . These reports shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project. Also to be included in the report is a summary of work proposed for the next reporting period. Specific requirements are set forth in the Work Statement. A one-page summary of each ongoing and completed protocol shall be submitted at this time. A monthly report will not be required for the period when the final report is due. Preprints and reprints of papers and abstracts shall be submitted with the Annual Report.

7

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

d.

SECTION III-Substantive performance; a description of current technical or substantive performance and any problems encountered and/or which may exist along with proposed corrective action. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and if behind planned progress what corrective steps are planned. Also to be included in the report is a summary of any significant decisions taken/pending and concerns/strategies needing to be addressed.

 

2.

Annual Technical Progress Report for Clinical Research Study Populations The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each study being performed under this contract. The contractor shall submit this information in the format indicated in the attachment entitled, “Inclusion Enrolment Report,” which is set forth in Section J of this contract. The contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. The contractor shall submit the report in accordance with ARTICLE F.1. DELIVERIES of this contract. In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies.

If this contract is for Phase III clinical trials, see ILB of these guidelines. The Guidelines may be found at the following website:

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

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

3.

Final Report By the expiration date of the contract, the Contractor shall submit three (3) copies of a comprehensive Final Report, as above, comprising two (2) copies to the Project Officer and one (1) copy to the Contracting Officer. This final report shall detail, document and summarize the results of the entire contract work for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. Specific requirements are set forth in the Work Statement. Preprints and reprints not submitted previously shall be submitted. The Final Report shall be submitted in accordance with ARTICLE F.1 DELIVERIES of this contract. An annual report will not be required for the period when the Final Report is due.

 

4.

Summary of Salient Results With the annual/final reports the Contractor shall submit a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

 

b.

Deliverables

 

			The following are considered deliverables under this contract:
	1.		All Technical Reports, Milestone Reports, preprints, and protocols as described in the Statement of Work. These deliverables are due as indicated in ARTICLE F.l DELIVERIES of this contract.
	2.		All milestones indicated in the Statement of Work, including the following plans for specific milestones: Product Development Plan (Milestone 1); Quality Systems Plan (Milestone 2); Clinical Testing Plan (Milestone 3); Animal Testing Plan (Milestone 4); Regulatory Support Plan (Milestone 5); Summary Report (Milestone 6); Large-Scale Production Plan (Milestone 9); Interim Clinical Trial Report (Milestone 10); and Interim Animal Studies Report (Milestone 11).

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11 including, but not limited to, the invention disclosure report,

8

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

the confirmatory license, and the government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986).In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(a)(2)(ii» shall be submitted to the Contracting Officer on the expiration date of the contract.

The final invention statement (see FAR 27.303(a)(2)(ii» shall be submitted on the expiration date of the contract to the following address:

Contracting Officer National Institutes of Health National Institute of Allergy and Infectious Diseases, CMP 6700B Rockledge Drive, Room 3214, MSC 7612 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.

SECTION D — PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

SECTION E — INSPECTION AND ACCEPTANCE

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 Project Officer is the authorized representative of the Contracting Officer.
c.		Inspection and acceptance will be performed at the address listed in Article G .1.
		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 No 52.246-8, INSPECTION OF RESEARCH AND DEVELOPMENT — COST REIMBURSEMENT (MAY 2001).

9

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

SECTION F — DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in Article C.I. 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 SECTION C, ARTICLE c.2. will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates specified below:

 

 

b.

In addition to the above, the following are deliverables under this contract. If the Government exercises its option pursuant to Article H.I 0 of this contract, the quantity will be increased as listed below:

 

 

c.

The above items shall be addressed and delivered to:

 

10

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

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

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. Also, the full text of a clause may be accessed electronically at this address: http://www.arnetgov/far/ .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER I) CLAUSE:

           52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).

SECTION G — CONTRACT ADMINISTRATION DATA

ARTICLE G.1. PROJECT OFFICER

The following Project Officers will represent the Government for the purpose of this contract:

Gerald R. Kovacs, Ph.D.
Senior Project Officer
Product Development Section
Office of Biodefense Research Affairs (OBRA)
Division of Microbiology and Infectious Diseases (DMID) National Institute
of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)
6610 Rockledge Drive
Room 5121, MSC 6604
Bethesda, MD 20892-6604
(Zip for express mail is 20817)
Phone: (301) 451-3511, (301) 402-4197
FAX: (301) 480-1263
gkovacs@niaid.nih.gov

Nancy Joie Watkins, M.S.
Alternate Project Officer
Product Development Section
Office of Biodefense Research Affairs (OBRA)
Division of Microbiology and Infectious Diseases (DMID) National Institute
of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)
6610 Rockledge Drive
Room 5004, MSC 6604
Bethesda, MD 20892-6604
(Zip for express mail is 20817)
Phone: (301) 451-6755 FAX: (301) 480-1263 nwatkins@niaid.nih.gov

The Project Officer is responsible for: (I) 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.

11

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

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: (I) 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 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 Project Officer designation.

ARTICLE G.2. KEY PERSONNEL

Pursuant to the Key Personnel clause incorporated in Section I of this contract, the following individual is considered to be essential to the work being performed hereunder:

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 instructions and the following directions for the submission of invoices/financing request must be followed to meet the requirements of a “proper” payment request pursuant to FAR 32.9.
		These instructions also provide for the submission of financial and personnel reporting required by IDISAR 342.7002.

 

(1)

Invoices/financing requests shall be submitted as follows:

 

	(a)		To be considered a “proper” invoice in accordance with FAR 32.9, each invoice shall clearly identify the two contract numbers that appear on the face page of the contract as follows:
			Contract No. IDISN266200400071C ADB Contract No. NOI-AI-40071
	(b)		An original and two copies to the following designated billing office:
			Contracting Officer National Institutes of Health National Institute of Allergy and Infectious Diseases, CMP 6700B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892 -7612

 

	(2)		Inquiries regarding payment of invoices should be directed to the designated billing office, (301) 496-0612.
	(3)

ARTICLE G.4. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter I) 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:

12

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health 6100 Building, Room 6B05 6100 EXECUTIVE BLVD MSC 7540 BETHESDA MD 20892-7540

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

ARTICLE G.5. GOVERNMENT PROPERTY

a.		In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of DHHS Publication, Contractor’s Guide for Control of Government Property , 1990, which is incorporated into this contract by reference. Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract. A copy of this publication is available upon request to the Contracts Property Administrator.
		Requests for information regarding property under this contract should be directed to the following office:

 

Division of Personal Property Services, NIH 601 I Building, Suite 637 6011 EXECUTIVE BLVD MSC 7670 BETHESDA MD 20852-7670 (301) 496-6466

 

b.

Notwithstanding the provisions outlined in the DHHS Publication, Contractor’s Guide for Control of Government Property , 1990 which is incorporated in this contract in paragraph a. above, the contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for performing annual inventories required under this contract.

ARTICLE G.6. POST A WARD 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 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, an interim evaluation will be prepared mid-point in the contract to coincide with the anniversary date of the contract.

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

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

b.

Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://ocm.od.nih.gov/cdmp/cps contractor.htm

13

 

Contract No. HHSN26620040071C
ADB Contract No. NOI-AI-40071

The registration process requires the contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the contractor will be required to identify an alternate contact who will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

SECTION H — SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS

The primary purpose of the Public Health Service (PHS) is to support and advance independent research within the scientific community. PHS has established effective, time tested and well recognized procedures for stimulating and supporting this independent research by selecting from multitudes of applications those research projects most worthy of support within the constraints of its appropriations. The reimbursement through the indirect cost mechanism of independent research and development costs not incidental to product improvement would circumvent this competitive process.

To ensure that all research and development projects receive similar and equal consideration, all organizations may compete for direct funding of independent research and development projects they consider worthy of support by submitting those projects to the appropriate Public Health Service grant office for review. Since these projects may be submitted for direct funding, the Contractor agrees that no costs for any independent research and development project, including all applicable indirect costs, will be claimed under this contract.

ARTICLE H.2. 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-OO-O39.html .

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.3. 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-l 07 .html
http://grants.nih.gov/grants/guide/notice-files/N OT -OD-00-03 8.html

14

 

Contract No. HHSN266200400071C
ADB Contract No. NOI-AI-40071

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 Plan and Board shall be established and approved prior to beginning the conduct of the clinical trial.

ARTICLE H.4. 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 3 10), 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.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

a.		Pursuant to Public Law(s) cited in paragraph b. , below, NIH is prohibited from using appropriated funds to support human embryo research. Contract funds may not be used for (I) 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 46.208(a)(2) 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