EX-10.44 2 a09-1850_1ex10d44.htm EX-10.44

Exhibit 10.44

AWARD/CONTRACT

1. THIS CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 350)

RATING

N/A

PAGE OF
1

PAGES
28

2. CONTRACT (Proc. Inst. Ident.) NO.
N01-AI-30052

3. EFFECTIVE DATE
September 30, 2003

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
VR075

5. ISSUED BY

CODE

2606-30052

6. ADMINISTERED BY (If other than Item 5)

CODE

National Institute of Health
Contract Management Branch, NIAID
Room 2230
8700-B Rockridge Dr. MSC 7612
Belhasda, Maryland 20892-7612

DMID-VR

RFP NIH-NIAID-DMID-03-29

7. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

8. DELIVERY

Avecia Limited

PO Box 42, Hexagon House

Blackley

Manchester M9 6ZS

England

o FOB ORIGIN

x OTHER (See below)

FOB Destination

9. DISCOUNT FOR PROMPT PAYMENT

N/A

10. SUBMIT INVOICES ADDRESS
SHOWN IN

ITEM

G.3.

CODE

FACILITY CODE

11. SHIP TO/MARK FOR

CODE

N/A

12. PAYMENT WILL BE MADE BY

CODE

N/A

Article F.1.

See Article G.3.

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

14. ACCOUNTING AND APPROPRIATION DATA

o 10 U.S.C. 2304(c) ( )

o 41 U.S.C. 253(c) ( )

15A. ITEM NO.

15B. SUPPLIES/SERVICES

15C. QUANTITY

15D. UNIT

15E. UNIT PRICE

15F. AMOUNT

Title: Production and Testing of Anthrax Recombinant Protective Antigen (rPA) Vaccine
Period, September 30, 2003 through October 12, 2006
Amount Allotted: $29,410,000
Contact Type: Cost Plus Fixed Fee/Completion

FY 03

FY 04

$29,410,000

$41,882,000

15Q TOTAL AMOUNT OF CONTRACT

$71,292,000

16. TABLE OF CONTENTS

(ü)

SEC.

DESCRIPTION

PAGE(S)

(ü)

SEC.

DESCRIPTION

PAGE(S)

PART I - THE SCHEDULE

PART II - CONTRACT CLAUSES

SOLICITATION/CONTRACT FORM

CONTRACT CLAUSES

SUPPLIES OR SERVICES AND PRICES/COST

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

DESCRIPTION/SPECS./WORK STATEMENT

LIST OF ATTACHMENTS

PACKAGING AND MARKING

PART IV - REPRESENTATIONS AND INSTRUCTIONS

INSPECTION AND ACCEPTANCE

REPRESENTATIONS, CERTIFICATIONS AND

DELIVERIES OR PERFORMANCE

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA

INSTRS., CONDS., AND NOTICES TO OFFERORS

SPECIAL CONTRACT REQUIREMENTS

EVALUATION FACTORS FOR AWARD

CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

17. x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign and return 2 copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)

18. o AWARD (Contractor is not required to sign this document.) Your offer on Solicitation Number , including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any condition sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.

19A. NAME AND TITLE OF SIGNER (Type or print)

David Greensmith

Chief Operating Officer (COO)

20A. NAME OF CONTRACTING OFFICER

Elizabeth Ozinski

Contracting Officer, CMB, NIAID, NIH

19B. NAME OF CONTRACTOR

20B. UNITED STATES OF AMERICA

19C. DATE SIGNED

20C. DATE SIGNED

/s/ David Greensmith

29 SEPTEMBER 2003

/s/ Elizabeth Ozinski

9/23/03

(Signature of person authorized to sign)

(Signature of Contracting Officer)

NSN 7640-01-152-8089

PREVIOUS EDITION UNUSABLE

M-107

Computer Generated

STANDARD FORM 26 (Rev. 4-A5)

Prescribed by GSA

FAR (48 CFR) 53.214(a)

Contract No. N01-AI-30052

DETAILED TABLE OF CONTRACT CONTENTS

PART I - THE SCHEDULE

	SECTION A - SOLICITATION/CONTRACT FORM

	SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS	4
	ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	4
	ARTICLE B.2. ESTIMATED COST AND FIXED FEE	4
	ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS	4
	ARTICLE B.4. ADVANCE UNDERSTANDINGS	5

	SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT	10
	ARTICLE C.1. STATEMENT OF WORK	10
	ARTICLE C.2. REPORTING REQUIREMENTS	10
	ARTICLE C.3. INVENTION REPORTING REQUIREMENT	11

	SECTION D - PACKAGING, MARKING AND SHIPPING	11

	SECTION E - INSPECTION AND ACCEPTANCE	11

	SECTION F - DELIVERIES OR PERFORMANCE	12
	ARTICLE F.1. DELIVERIES	12
	ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE	13

	SECTION G - CONTRACT ADMINISTRATION DATA	13
	ARTICLE G.1. PROJECT OFFICER	13
	ARTICLE G.2. KEY PERSONNEL	14
	ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT	14
	ARTICLE G.4. INDIRECT COST RATES	14
	ARTICLE G.5. GOVERNMENT PROPERTY	15
	ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	15

	SECTION H - SPECIAL CONTRACT REQUIREMENTS	16
	ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS	16
	ARTICLE H.2. HUMAN SUBJECTS	16
	ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS	16
	ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS	17
	ARTICLE H.5. HUMAN MATERIALS	17
	ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH	17
	ARTICLE H.7. NEEDLE EXCHANGE	17
	ARTICLE H.8. PRIVACY ACT	18
	ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS	18
	ARTICLE H.10. ANIMAL WELFARE	18
	ARTICLE H.11. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS	18
	ARTICLE H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS	18
	ARTICLE H.13. PUBLICATION AND PUBLICITY	19
	ARTICLE H.14. PRESS RELEASES	19
	ARTICLE H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	19
	ARTICLE H.16. ANTI -LOBBYING	19
	ARTICLE H.17. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES	20
	ARTICLE H.18. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORISM ACTIVITIES	20
	ARTICLE H.19. OFFICE OF HEALTH AND SAFETY - LABORATORY REGISTRATION/SELECT AGENT TRANSFER PROGRAM	20

Contract No. N01-AI-30052

	ARTICLE H.20. SELECT AGENT AWARDS TO FOREIGN CONTRACTORS STATUS		20
	ARTICLE H.21. POSSESSION, USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS		20

PART II - CONTRACT CLAUSES			22

	SECTION I - CONTRACT CLAUSES		22
	ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT		22
	ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES		24
	ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES		25
	ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT		26

PART III			27

	SECTION J - LIST OF ATTACHMENTS		27
	1.	Statement of Work	27
	2.	Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts	27
	3.	Inclusion Enrollment Report	27
	4.	Annual Technical Progress Report Format for Each Study	27
	5.	Research Patient Care Costs	27
	6.	Safety and Health	27
	7.	Procurement of Certain Equipment	27

PART IV			28

	SECTION K - REPRESENTATIONS AND CERTIFICATIONS		28
	1.	Representations and Certifications	28
	2.	Human Subjects Assurance Identification Number	28
	3.	Animal Welfare Assurance Number	28

Contract No. N01-AI-30052

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to continue development of the rPA vaccine and produce, test and release three million doses made from at least three cGMP consistency lots.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

a. The estimated cost of this contract is [***].

b. The fixed fee for this contract is [***]. The fixed fee shall be paid in installments based on the negotiated milestones set forth in ARTICLE B.4.h. and subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE 1.1. of this contract. Payment of fixed fee shall not be made in less than monthly increments.

c. The Government’s obligation, represented by the sum of the estimated cost plus fixed fee, is [***].

d. 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. These funds cover the start dates for Milestones 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17. For further provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized Substitutions of Clauses.

e. It is estimated that the amount currently allotted will cover performance of the contract through September 29, 2004.

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

g. Future increments to be allotted to this contract are estimated as follows:

FY	PERIOD	ESTIMATED COST	FIXED FEE	TOTAL AMOUNT

04	9/30/04 - 10/13/06	[***]	[***]	[***]

These funds cover continuation of Milestones 7, 9, 10, 11, 12, 13, and 17.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Special rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

(4) Travel to attend general scientific meetings;

(5) Foreign travel - See Paragraph b.(2) below;

(6) Consultant costs;

Contract No. N01-AI-30052

(7) Subcontracts;

(8) Patient care costs;

(9) Accountable Government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined and listed in the Contractor’s Guide for Control of Government Property), 1990, regardless of acquisition value.

b. Travel Costs

(1) Travel

(a) Total expenditures for 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 fur 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 type subcontract with Baxter Healthcare Corporation (BHC) for an amount not to exceed [***]. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation and the draft subcontract as required by the Subcontracts clause of the General Clauses incorporated in this contract. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

b. Subcontract

To negotiate a firm fixed price type subcontract with Baxter Pharmaceutical Solutions LLC (BPS) for an amount not to exceed [***]. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation and the draft subcontract as required by the Subcontracts clause of the General Clauses incorporated in this contract. 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. Subcontract

To negotiate a cost plus fixed fee type subcontract with DSTL for an amount not to exceed [***]. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation and the draft subcontract as required by the Subcontracts clause of the General Clauses incorporated in this contract. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

d. Subcontract

To negotiate a firm fixed price type subcontract with Parexel International Corporation (PxI) for an amount not to exceed [***]. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation and the draft subcontract as required by the Subcontracts clause of the General Clauses incorporated in this contract. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

5

Contract No. N01-AI-30052

e. Subcontract

To negotiate a firm fixed price type subcontract with Inveresk Ltd. for an amount not to exceed [***]. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the supporting documentation and the draft subcontract as required by the Subcontracts clause of the General Clauses incorporated in this contract. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

f. Subcontract

To negotiate a firm fixed price type subcontract with SRI International (SRI) for an amount not to exceed [***]. Award of the 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. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

g. Ceilings

(1) In no event shall the final amount reimbursable for the Overhead R&D Burn Rate using a base of Scientific Labor exceed a ceiling of 99% for the entire performance period of this contract.

(2) In no event shall the final amount reimbursable for Labor Overhead using a base of Direct Scientific Labor, plus R&D Burn on scientific labor, plus Direct Project Management Labor exceed a ceiling of 66% for the entire performance period of this contract.

(3) In no event shall the final amount reimbursable for Fringe Benefits exceed a ceiling of 38% for the entire performance period of this contract.

(4) In no event shall the final amount reimbursable for ABC 5000 facility daily rate exceed [***]. The contractor must submit to the Financial Advisory Services Branch, NIH the actual costs, excluding profit, for the ABC 5000 facility as of 12/31/03 and 12/31/04. The actual costs will be evaluated and the contractor will be required to make adjustments to the facility costs that have been reimbursed to the contractor based on the funded amount.

(5) This is authorization to charge as a direct cost to the contract a daily cost not to exceed [] per day for office leasing space for the first year of the contract in a total amount not to exceed a ceiling of [].

(6) The Government is not obligated to pay any additional amount should the final indirect cost rates exceed these negotiated ceiling rates. In the event that the final indirect cost rates are less than these negotiated ceiling rates, the Government’s obligation shall be reduced to conform to the lower rates. Any costs over and above this cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or cooperative agreement.

(7) The Contractor shall complete all work in accordance with the Statement of Work, terms and conditions of this contracts.

h. Contract Milestones

The Contractor shall complete all work in accordance with the Statement of Work and the contract milestones set forth below. The distribution of the fixed fee shall be paid in milestone based installments and payment of this fee is determined by the Project Officer’s written certification that the milestone has been satisfactorily performed and that the technical requirements have been met regarding the completion of the following milestones: If the Contractor meets the milestones earlier than the dates set forth below, then the fee will be paid at the earlier date after completion of the milestone.

Contract No. N01-AI-30052

	MILESTONES	ESTIMATED COST	FIXED FEE	TOTAL CPFF
	Milestones for Avecia

1	Submit refined preclinical testing plan on/before [***].	[***]	[***]	[***]

2	Submit refined clinical testing plan on/before [***].	[***]	[***]	[***]

3	Submit refined regulatory plan on/before [***].	[***]	[***]	[***]

4	Complete development and validation of assays on/before [***].	[***]	[***]	[***]

5	Demonstrated suitability of facility on/before [***].	[***]	[***]	[***]

6	Demonstrated tech transfer on/before [***].	[***]	[***]	[***]

7	Submit inventory storage/maintenance plan on/before [***].	[***]	[***]	[***]

8	Phase 2 trial completed on/before [***]. Reporting to NIAID and subsequent payment to be broken into three distinct phases: (1) initiation of enrollment (first patient enrolled) (2) Last patient out; and (3) delivery of final report to NIAID. Reports should include all data collected during the various phases of the study. Fee for this milestone shall be paid in 3 equal installments of the total fee for this milestone based on the completion of phases (1), (2), and (3) above.	[***]	[***]	[***]

9	Stockpile manufacturing feasibility plan on/before [***].	[***]	[***]	[***]

10	Manufacture all bulk rPA on/before [***] and fee will be paid after receipt of Certificate of Analysis.	[***]	[***]	[***]

11	Fill/Finish 3 million doses on/before [***] and fee will be paid after receipt of Certificate of Analysis.	[***]	[***]	[***]

12	Release of 3d cGMP lot, deliver or store 3 million doses on/before [***] and fee will be paid after receipt of Certificate of Analysis.	[***]	[***]	[***]

13	Second Phase 2 trial completed on/before [***]. Reporting to NIAID and subsequent payment to be broken into three distinct phases: (1) initiation of enrollment (first patient enrolled) (2) Last patient out; and (3) delivery of final report to NIAID. Reports should include all data collected during the various phases of the study. Fee for this milestone shall be paid in 3 equal installments of the total fee for this milestone based on the completion of phases (1), (2), and (3) above.	[***]	[***]	[***]

14	Preclinical studies completed on/before [***].	[***]	[***]	[***]

15	Complete regulatory plan on/before [***].	[***]	[***]	[***]

Contract No. N01-AI-30052

	MILESTONES	ESTIMATED COST	FIXED FEE	TOTAL CPFF
	Milestones for Avecia

16	Complete stability plan on/before [***]. Upon completion of 1st year, and 2nd year and 3rd year of stability testing and reporting, fee will be paid in partial payments.	[***]	[***]	[]*

17	Complete inventory storage/maintenance plan on/before [***].	[***]	[***]	[]*

i. Scientific Meetings

Travel to general scientific meetings as follows:

Authorization to expend contract funds for general scientific meeting travel is not provided herein. The Contractor shall request approval to expend contract funds for general scientific meeting travel, in writing, 4 weeks in advance of the proposed travel. The Contractor’s written request shall include the name(s) and title(s) of personnel proposed to travel, the meeting dates and location, details of proposed costs (airfare, per diem/subsistence, other), and a description of the benefit to be derived (to this contract) from the proposed travel.

j. Protocol Approvals

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

b. 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.

k. Subcontractor Estimated Expenditures

The Contractor shall include in their monthly invoice a list of estimated Subcontractor monthly expenditures for Subcontractors that have not submitted invoices for that respective month. If the Subcontractor(s) did not work and therefore did not incur costs during that respective month, then this should also be indicated on the monthly invoice.

l. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

(1) The contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

(a) Direct Labor- List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

(b) Fringe Benefits - Cite rate and amount

(c) Overhead - Cite rate and amount

(d) Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

(e) Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

(f) Subcontracts - Attach subcontractor invoice(s).

(g) Equipment - Cite authorization and amount.

(h) Total Cost

(i) Fixed Fee

(j) Total CPFF

Contract No. N01-AI-30052

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

(2) The contractor agrees to immediately notify the contracting officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost Clauses in the contract.

m. FAR Clause 52.223-6 Drug Free Workplace is included in this contract, however, FAR 23.501 (c) provides that the clause does not apply to work that is “(c) Performed outside of the United States and its outlying areas or any part of a contract performed outside the United States and its outlying areas.”

n. Understanding regarding FAR 52.222-36

FAR 22.1408(a) requires the Contracting Officer to “Insert the clause at 52.222-36, Affirmative Action for Workers with Disabilities, in solicitations and contracts that exceed or are expected to exceed $ 10,000, except when - -

“(1) Both performance of the work and the recruitment of workers will occur outside the United States, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island; or

“(2) The agency head has waived, in accordance with 22.1403(a) or 22.1403(b) all the terms of the clause.”

It is the mutual understanding of the contracting officer and Avecia that a significant portion of the work, including all self-performed work, under this contract will be performed outside the United States and the other named territories by workers recruited from outside the United States and the named territories. However, it is also mutually understood that some subcontracted work will be performed in the United States. Therefore both parties agree that FAR 52.222-36(a) (b) and (c) will not apply to Avecia and that FAR 52122-36 (d) “Subcontracts” will only apply to subcontracts that will be performed in the United States or by workers recruited from the United States and the named territories; i.e., FAR 52.222-36 would apply in its entirety to any subcontractor that performs work in the United States. It is also agreed that Avecia will flow-down language similar to that in this paragraph to its subcontracts not performed in the United Stales; i.e., FAR 52.222-36 would apply in its entirety to any second-tier (or lower) subcontracts performed in the United States.

o. Understanding regarding FAR 52.222-37

FAR 22.1310(a)(1)(i) provides that FAR 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans, is required to be in contracts over $25,000, except when “Work is performed outside the United States by employees recruited outside the United States”. As FAR 52.222-35(d) contains an “Applicability” clause that limits its reach to the listing of employment openings within the United States and named territories, no additional understanding beyond that applicability clause is necessary.

FAR 22.1310(b) provides that 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans, in solicitations and contracts containing the clause at 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans. Therefore, if “Work is performed outside the United States by Employees recruited outside the United States,” FAR 52.222-37 would not be required.

It is the mutual understanding of the contracting officer and Avecia that a significant portion of the work, including all self-performed work, under this contract will be performed outside the United States and the other named territories by workers recruited from outside the United States and the named territories. However, it is also mutually understood that some subcontracted work will be performed in the United States. Therefore both parties agree that FAR 52.222-37(a) through (c) will not apply to Avecia and that FAR 52.222-37 (f) will only apply to subcontracts that will be performed in the United States or by workers recruited from the United States; i.e., FAR 52.222-37 would apply in its entirety to any subcontractor that performs work in the United States It is also agreed that Avecia will flow-down language similar to that in this paragraph to its subcontracts not performed in the United States; i.e., FAR 52.222-37 would apply in its entirety to any second-tier (or lower) subcontracts performed in the United States.

Contract No. N01-AI-30052

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 accomplish the tasks and milestones in the Statement of Work, SECTION J, ATTACHMENT I, dated September 30, 2003, attached hereto and made a part of this contract. Performance and expenditures under this contract will be consistent with the work plans, schedule and budget described in the Contractor’s initial proposal dated June 30, 2003, and the Final Proposal Revision dated September 8, 2003, which includes the answers provided in Response to the Technical and Administrative Questions.

ARTICLE C.2. REPORTING REQUIREMENTS

The Contractor shall submit to the Contracting Officer and to the Project Officer technical progress reports covering the work accomplished during each reporting period. These reports are subject to the technical inspection and requests for clarification by the Project Officer. These shall be brief and factual and prepared in accordance with the following:

b. Technical Reports

The Contractor shall prepare and submit the following reports in the manner stated below:

(1) Monthly Technical Progress Reports - On the fifteenth of each month for the previous calendar month, the Contractor shall submit six (6) copies of a Monthly Technical Progress Report, comprising five (5) copies to the Project Officer and one (1) 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 - 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. 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 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.

d. SECTION III - Substantive performance; a description of current technical or substantive performance and any problems encountered and/or which may exist along with resolution or 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.

e. SECTION IV - Estimated and Actual Expenses

This report shall also contain a narrative statement as to whether there is any discrepancy at this time between the % of work completed and the cumulative costs incurred to date. Section IV of this report shall also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous month. These shall be listed for each Subcontractor. If the Subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.

Contract No. N01-AI-30052

(2) Milestone Reports - A milestone report will be provided after the completion of each Milestone unless otherwise agreed upon by the Principal Investigator and the Project Officer. Milestone reports and monthly reports may be combined if agreed by the Contracting Officer and the Project Officer. For those months when milestone reporting requirements are extensive, the monthly Technical Progress Report may not be required if agreed by the Project Officer, Contracting Officer and Contractor. Cost information for the month will be required in all cases.

(3) Final Report - By the expiration date of the contract, the Contractor shall submit five (5) copies of a comprehensive Final Report, as above, comprising four (4) 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.

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

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, 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 within 90 days after the expiration date of the contract to the following address:

Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases, CMB

6700-B Rockledge Drive, Room 2230

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 NTH 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

11

Contract No. N01-AI-30052

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)

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.1. and upon delivery and acceptance by the Contracting Officer, or the duty 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:

Item	Description	Delivery Schedule

1	Monthly Progress Reports	Fifteenth of each month

2	Milestone Reports	On the fifteenth day after completion of each milestone

3	Final Report	Expiration Date of the Contract

4	Summary of Salient Results	With the Final Report

b. The above items shall be addressed and delivered to:

Addressee	Deliverable Item	Quantity
Contracting Officer	Monthly Progress Reports	Original
CMB, NIAID, NIH	Milestone Reports	Original
Room 2230, MSC 7612	Final Report	Original
6700-B Rockledge Drive	Summary of Salient Results	Original
Bethesda, MD 20892-7612

Project Officer	Monthly Progress Reports	5 Copies
DMID/NIAID/NIH	Milestone Reports	5 Copies
6610 Rockledge Dr.,	Final Report	5 Copies
Room 5002	Summary of Salient Results	5 Copies
Bethesda, MD 20892-7630

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c. Other Reports/Deliverables

The following are considered deliverables under this contract:

5. All Technical Reports, Milestone Reports, preprints, and protocols as described in paragraph A, above. These deliverables are due as indicated.

6. All milestones indicated in the Statement of Work.

If the Contractor becomes unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delay, the reasons for the delay, and the expected date of delivery for the report.

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.arnet.gov/far/.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

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

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. PROJECT OFFICER

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

Ed Nuzum, DVM, Ph.D.
Project Officer
Office of Biodefense Research Affairs (OBRA)/DMID/NIAID/NIH
Mail Stop Code 6604
6610 Rockledge Drive, Room 5117
Bethesda, MD 20892-6604
Phone: (301) 451-6737
Fax: (301) 480-1263
Email: enuzum@niaid.nih.gov

Eileen Flynn
Co-Project Officer
Office of Biodefense Research Affairs (OBRA)/DMID/NIAID/NIH
Mail Stop Code 7630
6610 Rockledge Drive, Room 5002
Bethesda, MD 20892-7630
Phone: (301) 451-6737
Fax: (301) 480-1263
Email: eflynn@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.

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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: (l) 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 Contracting Officer hereby delegates the Project Officer as the Contracting Officer’s authorized representative responsible for signing software license agreements issued as a result 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 this contract, the following individual is considered to be essential to the work being performed hereunder:

Name		Title

Matthew G. Duchars, BSc, PhD		Principal Investigator

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 HHSAR 342.7002.

(1) Invoices/financing requests shall be submitted as follows:

An original and two copies to the following designated billing office:

Contracting Officer
Contract Management Branch
National Institute of Allergy and Infectious Diseases, NIH
Room 2230
6700-B ROCKLEDGE DRIVE, MSC 7612
BETHESDA, MD 20892-7612

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

b. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the salary rate limitation provisions as specified in ARTICLE H.11. 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 P.L. 108-7 and ARTICLE H.11. 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 1, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Contract No. N01-AI-30052

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
6011 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. This form is included as an attachment in SECTION J of this contract.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluations will be prepared annually 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

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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. HUMAN SUBJECTS

RESEARCH INVOLVING HUMAN SUBJECTS SHALL NOT BE CONDUCTED UNDER THIS CONTRACT UNTIL THE PROTOCOL DEVELOPED IN PHASE II 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).

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. 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.

Contract No. N01-AI-30052

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 I07

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, the NIAID Clinical Terms of Award ( http://www.niaid.nih.gov/ncn/clinical/default_human.htm ), 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 and Plan shall be established and approved prior to beginning the conduct of the clinical trial.

ARTICLE H.5. HUMAN MATERIALS

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

ARTICLE H.6. 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 (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 46.208(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, Federal funds may not be used for cloning of human beings.

b.	Public Law and Section No.	Fiscal Year	Period Covered

	P.L. 108-7, Division G, Title V-General Provisions, Section 510	2003	10/1/02 - 9/30/03

ARTICLE H.7. NEEDLE EXCHANGE

a.	Pursuant to Public Law(s) cited in paragraph b., below, contract funds shall not be used to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

b.	Public Law and Section No.	Fiscal Year	Period Covered

	P.L. 108-7, Division G, Title V-General Provisions, Section 505	2003	10/1/02 - 9/30/03

Contract No. N01-AI-30052

ARTICLE H.8. PRIVACY ACT

This procurement action requires the Contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties.

The Privacy Act System of Records applicable to this project is Number 09-25-0200. “This document may be accessed on the Internet at the following URL: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm.

ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

No rodent or rodent product shall be delivered into the NIH, NIAID environment (NIH) directly, or through collaborative research or holding facilities under contract to NIAID except by permit. Direct shipments to NIH from a commercial colony will be considered exempt. Non-exempt sources must be approved by permit issued through the National Center for Research Resources (NCRR). The permit must be obtained by the Contractor prior to the shipment to NIH of the rodents and/or rodent products. The Contractor must be sure that this permit exists and is current before transferring rodents or rodent products into the NIH, NIAID environment. Refusal or negligence to do so will be considered a material breach of contract and may be treated as any other such material breach. Applications for permits should be submitted not less than 30 days prior to shipping date to: NIH Veterinary Resources Branch (VRP), National Center for Research Resources (NCRR), Scientific Services Branch, Laboratory Sciences Section, Building 28A, Room 111, 28 LIBRARY DR MSC 5210, BETHESDA MD 20892-5210, (301)496-2527.

ARTICLE H.10. ANIMAL WELFARE

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

ARTICLE H.11. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS

UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE (PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS WITHOUT PRIOR APPROVAL BY THE OFFICE OF LABORATORY ANIMAL WELFARE (OLAW), OF AN ASSURANCE TO COMPLY WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES (e.g. COLLABORATING INSTITUTIONS, SUBCONTRACTORS, SUBGRANTEES) WITHOUT OLAW-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN.

ARTICLE H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS

Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year funds may be used to pay the direct salary of an individual through this contract at a rate in excess of applicable amount shown for the fiscal year covered. Direct salary is exclusive of fringe benefits, overhead, and general and administrative expenses (also referred to as “indirect cost” or “facilities and administrative (F&A) costs”). Direct salary has the same meaning as the term “institutional base salary.” An individual’s direct salary (or institutional base salary) is the annual compensation that the contractor pays for an individual’s appointment whether that individual’s time is spent on research, teaching, patient care or other activities. Direct salary (or institutional base salary) excludes any income that an individual may be permitted to earn outside of duties to the contractor. The per year salary rate limit also applies to individuals proposed under subcontracts. It does not apply to fees paid to consultants. If this is a multiple year contract, it may be subject to unilateral modifications by the Government if an individual’s salary rate exceeds any salary rate ceiling established in future HHS appropriation acts.

b.	Public Law No.	Fiscal Year	Dollar Amount of Salary Limitation*

	P.L. 108-7, Division G, Title II-General Provisions, Section 204	2003	Executive Level 1

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b. Direct salaries which will be paid with FY-03 funds are limited to the Executive Level I rate which was in effect on the date(s) the expense was incurred.

*For contract expenditures using FY-03 funds, the period 10/1/02 - 12/31/02 the Executive Level rate is $166,700. Effective 1/1/03, for contract expenditures using FY-03 funds, the Executive Level 1 rate is increased to $171,900 and will remain at that level until such time as it is determined to raise the Executive Schedule annual rates. See the web site listed below for Executive Schedule rates of pay.

LINK to EXECUTIVE LEVEL SALARIES: http://opm.gov.oca/PAYRATES/index.htm

(Click on “Executive Schedule” for the current Fiscal Year’s salary rate or scroll down to the “General Schedule Salary Tables from Previous Years” to locate the Executive Level salary rates from previous years.)

ARTICLE H.13. PUBLICATION AND PUBLICITY

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. N01-AI- 30052.”

ARTICLE H.14. PRESS RELEASES

a. Pursuant to Public Law(s) cited in paragraph b., below, 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.

Public Law and Section No.	Fiscal Year	Period Covered

P.L. 108-7, Division G, Title V-General Provisions, Section 507	2003	10/1/02 - 9/30/03

ARTICLE H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dh.hs.gov and the mailing address is:

	Office of Inspector General
	Department of Health and Human Services
	TIPS HOTLINE
	P.O. Box 23489
	Washington, D.C. 20026

ARTICLE H.16. ANTI -LOBBYING

a. Pursuant to Public Law(s) cited in paragraph c, below, contract funds shall not be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State legislature, except in presentation to the Congress or any State legislature itself.

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b. Contract funds shall not be used to pay salary or expenses of the contractor or any agent acting for the contractor, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature.

Public Law and Section No.	Fiscal Year	Period Covered

for a., above: P.L. 108-7, Division G, Title V-General Provisions, Section 503a	2003	10/1/02 - 9/30/03

for b., above: P.L. 108-7, Division G, Title V. General Provisions, Section 503b	2003	10/1/02 - 9/30/03

ARTICLE H.17. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

Unique research resources arising from NIH-funded research are to be shared with the scientific research community. NIH provides guidance, entitled, “Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts,” (Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate terms for disseminating and acquiring these research resources. This guidance, found at:

http://ott.od.nih.gov/NewPages/64FR72090.pdf is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will facilitate further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

Note: For the purposes of this Article, the terms, “research tools,” “research materials,” and “research resources” are used interchangeably and have the same meaning.

ARTICLE H.18. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORISM ACTIVITIES

The Contractor acknowledges that U. S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

ARTICLE H.19. OFFICE OF HEALTH AND SAFETY - LABORATORY REGISTRATION/SELECT AGENT TRANSFER PROGRAM

The awardee is responsible for ensuring that all work under this grant, cooperative agreement, or contract complies with all Federal requirements related to select agents including DCDs that can be found at http://www.cdc.gov/od/ohs/1rsat.htm and NTH’s OBA that can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-052.htm.

ARTICLE H.20. SELECT AGENT AWARDS TO FOREIGN CONTRACTORS STATUS

This award includes research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens). Before using contract funds for any work directly involving the Select Agents, the contractor must provide information satisfactory to the NIH that a process equivalent to that described in 42 CFR 73 for US institutions is in place and will be administered for all Select Agent work covered by the contract. The contractor must address the following key elements for their institution: safety; security; training; procedures for ensuring that only approved/appropriate individuals have access to the Select Agents; and any applicable laws, regulations and policies equivalent to 42 CFR 73.

ARTICLE H.21. POSSESSION, USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

Work involving select biological agents or toxins shall not be conducted under this contract until the contractor and any affected subcontractor(s) are granted a certificate of registration or are authorized to work with the applicable select agents.

For possession, use and transfer of biological agents or toxins that have been determined to have the potential to pose a severe threat to: 1) public health and safety; 2) both human and animal health; animal health, or animal products; and/or 3) plant health or plant products, registration information must be submitted to the Centers for Disease Control and Prevention,

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Department of Health and Human Services (DHHS) or the Animal and Plant Health inspection Service (APHIS), U.S. Department of Agriculture (USDA) as applicable.

Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program Web site at http://www.cdc.gov/od/sap.

Contract No. N01-AI-30052

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT - FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arpet.gov/far/.

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

FAR CLAUSE NO.	DATE	TITLE

52.202-1	Dec 2001	Definitions

52.203-3	Apr 1984	Gratuities (Over $100,000)

52.203-5	Apr 1984	Covenant Against Contingent Fees (Over $100,000)

52.203-6	Jul 1995	Restrictions on Subcontractor Sales to the Government (Over $100,000)

52.203-7	Jul 1995	Anti-Kickback Procedures(Over $100,000)

52.203-8	Jan 1997	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)

52.203-10	Jan 1997	Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)

52.203-12	Jun 2003	Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)

52.204-4	Aug 2000	Printed or Copied Double-Sided on Recycled Paper (Over $100,000)

52.209-6	Jul 1995	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $25,000)

52.215-2	Jun 1999	Audit and Records - Negotiation (Over $100,000)

52.215-8	Oct 1997	Order of Precedence - Uniform Contract Format

52.215-10	Oct 1997	Price Reduction for Defective Cost or Pricing Data

52.215-12	Oct 1997	Subcontractor Cost or Pricing Data (Over $500,000)

52.215-14	Oct 1997	Integrity of Unit Prices (Over $100,000)

52.215-15	Dec 1998	Pension Adjustments and Asset Reversions

52.215-18	Oct 1997	Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

52.215-19	Oct 1997	Notification of Ownership Changes

52.215-21	Oct 1997	Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data - Modifications

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52.216-7	Dec 2002	Allowable Cost and Payment

52.216-8	Mar 1997	Fixed Fee

52.219-8	Oct 2000	Utilization of Small Business Concerns (Over $100,000)

52.219-9	Jan 2002	Small Business Subcontracting Plan (Over $500,000)

52.219-16	Jan 1999	Liquidated Damages - Subcontracting Plan (Over $500,000)

52.222-2	Jul 1990	Payment for Overtime Premium (Over $100,000) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)

52.222-3	Jun 2003	Convict Labor

52.222-26	Apr 2002	Equal Opportunity

52.222-35	Dec 2001	Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

52.222-36	Jun 1998	Affirmative Action for Workers with Disabilities

52.222-37	Dec 2001	Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

52.223-6	May 2001	Drug-Free Workplace

52.223-14	Jun 2003	Toxic Chemical Release Reporting

52.225-1	Jun 2003	Buy American Act - Supplies

52.225-13	Jun 2003	Restrictions on Certain Foreign Purchases

52.227-1	Jul 1995	Authorization and Consent, Alternate I (Apr 1984)

52.227-2	Aug 1996	Notice and Assistance Regarding Patent and Copyright Infringement (Over $100,000)

52.227-11	Jun 1997	Patent Rights - Retention by the Contractor (Short Form) (Note: In accordance with FAR 27.303(a)(2), paragraph (f) is modified to include the requirements in FAR 27.303(a)(2)(1) through (iv). The frequency of reporting in (I) is annual.

52.227-14	Jun 1987	Rights in Data - General

52.232-9	Apr 1984	Limitation on Withholding of Payments

52.232-17	Jun 1996	Interest (Over $100,000)

52.232-20	Apr 1984	Limitation of Cost

52.232-23	Jan 1986	Assignment of Claims

52.232-25	Feb 2002	Prompt Payment, Alternate I (Feb 2002)

52.232-34	May 1999	Payment by Electronic Funds Transfer-Other Than Central Contractor Registration

52.233-1	Jul 2002	Disputes

52.233-3	Aug 1996	Protest After Award, Alternate I (Jun 1985)

52.242-1	Apr 1984	Notice of Intent to Disallow Costs

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52.242-3	May 2001	Penalties for Unallowable Costs (Over $500,000)

52.242-4	Jan 1997	Certification of Final Indirect Costs

52.242-13	Jul 1995	Bankruptcy (Over $100,000)

52.243-2	Aug 1987	Changes - Cost Reimbursement, Alternate V (Apr 1984)

52.244-2	Aug 1998	Subcontracts, Alternate II (Aug 1998) *If written consent to subcontract is required, the identified subcontracts are listed in ARTICLE B, Advance Understandings.

52.244-5	Dec 1996	Competition in Subcontracting (Over $100,000)

52.245-5	Jun 2003	Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)

52.246-23	Feb 1997	Limitation of Liability (Over $100,000)

52.249-6	Sep 1996	Termination (Cost-Reimbursement)

52.249-14	Apr 1984	Excusable Delays

52.253-1	Jan 1991	Computer Generated Forms

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

HHSAR CLAUSE NO.	DATE	TITLE

352.202-1	Jan 2001	Definitions - with Alternate paragraph (h) (Jan 2001)

352.216-72	Oct 1990	Additional Cost Principals

352.228-7	Dec 1991	Insurance - Liability to Third Persons

352.232-9	Apr 1984	Withholding of Contract Payments

352.233-70	Apr 1984	Litigation and Claims

352.242-71	Apr 1984	Final Decisions on Audit Findings

352.270-5	Apr 1984	Key Personnel

352.270-6	Jul 1991	Publications and Publicity

352.270-7	Jan 2001	Paperwork Reduction Act

[ End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT - Rev. 6/2003].

ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

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

FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefor. Note: When this contract is fully funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no longer apply and FAR Clause 52.232-20, LIMITATION OF COST will become

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applicable.

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 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997).

(2) FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JANUARY 1999).

“(c) Waiver of evaluation preference……

[ ] Offeror elects to waive the evaluation preference.”

(3) FAR 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (JUNE 2003).

“(b) Evaluation adjustment. (1) The Contracting Officer will evaluate offers by adding a factor of 10% to the price of all offers, except—…”

(4) FAR 52.224- 1, Privacy Act Notification (APRIL 1984)

(5) FAR 52.224-2, Privacy Act (APRIL 1984)

(6) FAR 52.225-5, Trade Agreements Act

(7) FAR 52.227-14, Rights in Data - General (JUNE 1987)

(8) FAR 52.242-3, Penalties for Unallowable Costs (MAY 2001).

(9) FAR 52.247-63, Preference for U.S. Flag Air Carriers (JUNE 2003)

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

(1) HHSAR 352.223-70, Safety and Health (JANUARY 2001). [This clause is provided in full text in SECTION J - ATTACHMENTS.]

(2) HHSAR 352.270-8, Protection of Human Subjects (JANUARY 2001).

Note: The Office for Human Research Protections (OHRP), Office of the Secretary (OS), Department of Health and Human Services (DHHS) is the office responsible for oversight of the Protection of Human subjects and should replace Office for Protection from Research Risks (OPRR), National institutes of Health (NIH) wherever it appears in this clause.

(3) HHSAR 352.270-9, Care of Live Vertebrate Animals (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)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin 81-16).

(2) NIH(RC) [ ], Research Patient Care Costs (4/1/84).

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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 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (APRIL 2003)

(a) Definitions. As used in this clause-

Commercial item, has the meaning contained in the clause at 52.202-1, Definitions.

Subcontract, includes a transfer of commercial items between divisions, subsidiaries, or affiliates of the Contractor or subcontractor at any tier.

(b) To the maximum extent practicable, the Contractor shall incorporate, and require its subcontractors at all tiers to incorporate, commercial items or nondevelopmental items as components of items to be supplied under this contract.

(i) 52.219-8, Utilization of Small Business Concerns (OCT 2000) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $500,000 ($1,000,000 for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(ii) 52.222-26, Equal Opportunity (APR 2002) (E.O. 11246).

(iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)).

(iv) 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C. 793).

(v) 52.247-64, Preference for Privately Owned U.S. - Flag Commercial Vessels (APR 2003) (46 U.S.C. Appx 1241 and 10 U.S.C. 2631) (flow down required in accordance with paragraph (d) of FAR clause 52.247 64).

(2) While not required, the Contractor may flow down to subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(d) The Contractor shall include the terms of this clause, including this paragraph (d), in subcontracts awarded under this contract.

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PART III

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

1. Statement of Work, September 30, 2003, 3 pages.

2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97), 5 pages.

3. Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.

4. Annual Technical Progress Report Format for Each Study, July 1994, 1 page.

5. Safety and Health, HHSAR Clause 352.223-70, (1/01), 1 page.

6. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1 page.

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

8. Report of Government Owned, Contractor Held Property, 1 page.

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PART IV

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

1. Representations and Certifications, dated September 4, 2003

2. Human Subjects Assurance Identification Number FWA00004876, dated June 6, 2003

3. Animal Welfare Assurance Number for Subcontractor DSTL, A5537-01, dated October 7, 2002.

END of the SCHEDULE
(CONTRACT)

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Statement of Work

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Statement of Work		ATTACHMENT 1
(September 30, 2003)		Page 1

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Statement of Work

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Statement of Work		ATTACHMENT 1
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Statement of Work

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Statement of Work		ATTACHMENT 1
(September 30, 2003)		Page 3

Contract No. N01-AI-30052

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4

General: The contractor shall submit claims for reimbursement in the manner and format described herein and as illustrated in the sample invoice/financing request.

Format: Standard Form 1034, “Public Voucher for Purchases and Services Other Than Personal,” and Standard Form 1035, “Public Voucher for Purchases and Services Other Than Personal— Continuation Sheet,” or reproduced copies of such forms marked ORIGINAL should be used to submit claims for reimbursement. In lieu of SF-1034 and SF-1035, claims may be submitted on the payee’s letter-head or self-designed form provided that it contains the information shown on the sample invoice/financing request.

Number of Copies: As indicated in the Invoice Submission Clause in the contract.

Frequency: Invoices/financing requests submitted in accordance with the Payment Clause shall he submitted monthly unless otherwise authorized by the contracting officer.

Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by precontract cost provisions.

Billing of Costs Incurred: If billed costs include: (1) costs of a prior billing period, but not previously billed; or (2) costs incurred during the contract period and claimed after the contract period has expired, the amount and month(s) in which such costs were incurred shalt be cited.

Contractor’s Fiscal Year: Invoices/financing requests shall be prepared in such a manner that costs claimed can be identified with the contractor’s fiscal year.

Currency: All NIH contracts are expressed in United States dollars. When payments are made in a currency other than United States dollars, billings on the contract shall be expressed, and payment by the United States Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

Costs Requiring Prior Approval: Costs requiring the contracting officer’s approval, which are not set forth in an Advance Understanding in the contract shall be so identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, any cost set forth in an Advance Understanding shall be shown as a separate line item on the request.

Invoice/Financing Request Identification: Each invoice/financing request shall be identified as either:

(a) Interim Invoice/Contract Financing Request - These are interim payment requests submitted during the contract performance period.

(b) Completion Invoice - The completion invoice is submitted promptly upon completion of the work; but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which this contract is physically complete (whichever date is later). The completion invoice should be submitted when all costs have been assigned to the contract and all performance provisions have been completed.

(c) Final Invoice - A final invoice may be required after the amounts owed have been settled between the Government and the contractor (e.g., resolution of all suspensions and audit exceptions).

Preparation and Itemization of the Invoice/Financing Request: The contractor shall furnish the information set forth in the explanatory notes below. These notes are keyed to the entries on the sample invoice/financing request.

(a) Designated Billing Office Name and Address - Enter the designated billing office and address, identified in the Invoice Submission Clause of the contract, on all copies of the invoice/financing request.

(b) Invoice/Financing Request Number - Insert the appropriate serial number of the invoice/financing request.

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(d) Contract Number and Date - Insert the contract number and the effective date of the contract.

(e) Payee’s Name and Address - Show the contractors name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the contractor, or a different payee has been designated, then insert the name and address of the payee instead of the contractor.

(f) Total Estimated Cost of Contract - Insert the total estimated cost of the contract, exclusive of fixed-fee. For incrementally funded contracts, enter the amount currently obligated and available for payment.

(g) Total Fixed-Fee - Insert the total fixed-fee (where applicable). For incrementally funded contracts, enter the amount currently obligated and available for payment.

(h) Billing Period - Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

(i) Incurred Cost - Current - Insert the amount billed for the major cost elements, adjustments, and adjusted amounts for the current period.

(j) Incurred Cost - Cumulative - Insert the cumulative amounts billed for the major cost elements and adjusted amounts claimed during this contract.

(k) Direct Costs - Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

(1) Direct Labor - Include salaries and wages paid (or accrued) for direct performance of the contract. For Key Personnel, list each employee on a separate line. List other employees as one amount unless otherwise required by the contract.

(2) Fringe Benefits - List any fringe benefits applicable to direct labor and billed as a direct cost. Fringe benefits included in indirect costs should not be identified here.

(3) Accountable Personal Property - Include permanent research equipment and general purpose equipment having a unit acquisition cost of S1,000 or more and having an expected service life of more than two years, and sensitive property regardless of cost (see the DHHS Contractor’s Guide for Control of Government Property). Show permanent research equipment separate from general purpose equipment. Prepare and attach Form HHS-565, “Report of Accountable Property,” in accordance with the following instructions:

List each item for which reimbursement is requested. A reference shall be made to the following (as applicable):

· The item number for the specific piece of equipment listed in the Property Schedule.

· The Contracting Officer’s Authorization letter and number, if the equipment is not covered by the Property Schedule.

· Be preceded by an asterisk (*) if the equipment is below the approval level.

(4) Materials and Supplies- Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.

(5) Premium Pay - List remuneration in excess of the basic hourly rate.

(6) Consultant Fee - List fees paid to consultants. Identify consultant by name or category as set forth in the contract’s Advance Understanding or in the COA letter, as well as the effort (i.e., number of hours, days, etc.) and rate being billed.

(7) Travel - Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be

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(8) billed separately from domestic travel.

(9) Subcontract Costs - List subcontractor(s) by name and amount billed.

(10) Other - List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.

(l) Cost of Money (COM) - Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed_

(m) Indirect Costs-Overhead - Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.

(n) Fixed-Fee Earned - Cite the formula or method of computation for the fixed-fee (if any). The fixed-fee must be claimed as provided for by the contract.

(o) Total Amounts Claimed - Insert the total amounts claimed for the current and cumulative periods.

(p) Adjustments - Include amounts conceded by the contractor, outstanding suspensions, and/or disapprovals subject to appeal.

(q) Grand Totals

The contracting officer may require the contractor to submit detailed support for costs claimed on one or more interim invoices/financing requests.

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FINANCIAL REPORTING INSTRUCTIONS:

These instructions are keyed to the Columns on the sample invoice/financing request.

Column A - Expenditure Category - Enter the expenditure categories required by the contract.

Column B - Cumulative Percentage of Effort/Hrs.-Negotiated - Enter the percentage of effort or number of hours agreed to doing contract negotiations for each employee or labor category listed in Column A.

Column C - Cumulative Percentage of Effort/Hrs.-Actual - Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.

Column D - Incurred Cost-Current - Enter the costs, which were incurred during the current period.

Column E-Incurred Cost-Cumulative - Enter the cumulative cost to date.

Column F - Cost at Completion - Enter data only when the contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates are essential.

Column G - Contract Amount - Enter the costs agreed to during contract negotiations for all expenditure categories listed in Column A.

Column H - Variance (Over or Under) - Show the difference between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made in Column F. This column need not be filled in when Column F is blank. When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column F by Column G, an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications: Any modification in the amount negotiated for an item since the preceding report should be listed in the appropriate cost category.

Expenditures Not Negotiated: An expenditure for an item for which no amount was negotiated (e.g., at the discretion of the contractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in, except for G. Column H will of course show a 100 percent variance and will be explained along with those identified under H above.

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Contract No. N01-AI-30052

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

(a)	Billing Office Name and Address

	NATIONAL INSTITUTES OF HEALTH
	National Institute of Allergy and Infectious Diseases.
	Room 2230, MSC 7612
	6700-B Rockledge Drive
	Bethesda, MD 20892-7612

(b)	Invoice/Financing Request No.

(c)	Date Invoice Prepared

(d)	Contract No.

Effective Date

(e)	Payee’s Name and Address

	ABC CORPORATION
	100 Main Street
	Anywhere, USA zip code

Attn:	Name, Title, & Phone Number of Official to Whom Payment is Sent

(f)	Total Estimated Cost

(g)	Total Fixed Fee

(h)	This invoice/financing request represents reimbursable costs for the period from to

Cumulative Percentage of
Effort/Hrs.

Incurred Cost

Cost at
Completion
F

Contract
Amount
G

Variance
H

Expenditure Category*
A

Negotiated
B

Actual
C

(i) Current
D

(j) Cumulative
E

(k) Direct Costs

(1) Direct Labor

(2) Fringe Benefits

(3) Accountable Property (attach HHS-565)

(4) Materials & Supplies

(5) Premium Pay

(6) Consultant Fees

(7) Travel

(8) Subcontracts

(9) Other

Total Direct Costs

(l) Cost of Money

(m) Overhead

G&A

(n) Fixed Fee

(o) Total Amount Claimed

(p) Adjustments

(q) Grand Totals

I certify that all payments are for appropriate purposes and in accordance with the contract.


	(Name of Official)		(Title)

* Attach details as specified in the contract

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Contract No. N01-AI-30052

INCLUSION ENROLLMENT REPORT

This report format should NOT be used for data collection from study participants

Study Title:

Total Enrollment:	Protocol Number:
Contract Number:

PART A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race

	Sex/Gender
	Females	Males	Unknown or Not Reported	Total
Ethnic Category
Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals not reporting ethnicity)
Ethnic Category: Total of All Subjects*
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More than one race
Unknown or not reported
Racial Categories: Total of All Subjects*

PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

	Females	Males	Unknown or Not Reported	Total
Racial Categories
American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown or not reported
Racial Categories: Total of Hispanics or Latinos**

*These totals must agree

**These totals must agree

Inclusion Enrollment Report	ATTACHMENT 3
5/2001 (Modified OAMP: 10/2001)

Contract No. N01-AI-30052

ANNUAL TECHNICAL PROGRESS REPORT FORMAT

Study Title:

Date:

Provide the number of subject enrolled in the study to date according to the following categories:

American
Indian or
Alaskan
Native

Asian or
Pacific
Islander

Black,
not of
Hispanic
Origin

Hispanic

White,
not of
Hispanic
Origin

Other
or
Unknown

Total

Female

Male

Unknown

TOTAL

Subpopulations of the minority groups should also be reported, using a similar format.

Annual Technical Progress Report Format	ATTACHMENT 4
July, 1994

Contract No. N01-AI-30052

HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001)

(a) To help ensure the protection of the life and health of all persons and to help prevent damage to property, the Contractor shall comply with all Federal, State and local laws and regulations applicable to the work being performed under the contract. These laws are implemented and/or enforced by the Environmental Protection Agency, Occupational Safety and Health Administration and other agencies at the Federal, State and local levels (Federal, State and local regulatory/enforcement agencies).

(b) Further, the Contractor shall take or cause to be taken additional safety measures as the Contracting Officer in conjunction with the project or other appropriate officer, determines to be reasonably necessary. If compliance with these additional safety measures results in an increase or decrease in the cost or time required for performance of any part of work under this contract, an equitable adjustment will be made in accordance with the applicable “Changes” Clause set forth in this contract.

(c) The Contractor shall maintain an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; and/or damage to property incidental to work performed under the contract and all violations for which the Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report shall include a copy of the notice of violation and the findings of any inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State or local regulatory/enforcement agency and the time frame allowed by the agency to accomplish the necessary corrective action.

(d) If the Contractor fails or refuses to comply promptly with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective action (as approved by the Federal, State or local regulatory/enforcement agencies) has been taken and documented to the Contracting Officer. No part of the time lost due to any stop work order shall be subject to a claim for extension of time or costs or damages by the Contractor.

(e) The Contractor shall insert the substance of this clause in each subcontract involving toxic substances, hazardous materials, or operations. Compliance with the provisions of this clause by subcontractors will be the responsibility of the Contractor.

(End of clause)

Safety and Health Clause	ATTACHMENT 5
HHSAR 352.223-70, (1/01)

Contract No. N01-AI-30052

PROCUREMENT OF CERTAIN EQUIPMENT

Notwithstanding any other clause in this contract, the Contractor will not be reimbursed for the purchase, lease, or rental of any item of equipment listed in the following Federal Supply Groups, regardless of the dollar value, without the prior written approval of the Contracting Officer.

67 -	Photographic Equipment
69 -	Training Aids and Devices
70 -	General Purpose ADP Equipment, Software, Supplies and Support (Excluding 7045-ADP Supplies and Support Equipment.)
71 -	Furniture
72 -	Household and Commercial Furnishings and Appliances
74 -	Office Machines and Visible Record Equipment
77 -	Musical Instruments, Phonographs, and Home-type Radios
78 -	Recreational and Athletic Equipment

When equipment in these Federal Supply Groups is requested by the Contractor and determined essential by the Contracting Officer, the Government will endeavor to fulfill the requirement with equipment available from its excess personal property sources, provided the request is made under a contract. Extensions or renewals of approved existing leases or rentals for equipment in these Federal Supply Groups are excluded from the provisions of this article.

NIH(RC)-7 (4/1/84)	ATTACHMENT 6
OMB Bulletin 81-16

Contract No. N01-AI-30052

RESEARCH PATIENT CARE COSTS

(a) Research patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract.

(b) Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative.

(c) Prior to submitting an invoice for patient care costs under this contract, the contractor must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care.

(d) The contractor must maintain adequate procedures to identify those research patients participating in this contract who are eligible for third party reimbursement.

(e) Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions of the contract are chargeable to this contract.

NIH(RC)-11	ATTACHMENT 7
(4/1/84)

Contract No. N01-AI-30052

REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY

CONTRACTOR:	CONTRACT NUMBER

ADDRESS	REPORT DATE:

	FISCAL YEAR:

BEGINNING OF
PERIOD

ADJUSTMENTS

END OF PERIOD

CLASSIFICATION

#ITEMS

VALUE

GFP
ADDED

CAP ADDED

DELETIONS

#ITEMS

VALUE

LAND>=$25K

LAND<$25K

OTHER REAL>=$25K

OTHER REAL<$25K

PROPERTY UNDER CONST>=$25K

PROPERTY UNDER CONST<$25K

PLANT EQUIP>=$25K

PLANT EQUIP<$25K

SPECIAL TOOLING>=$25K

SPECIAL TOOLING<$25K

SPECIAL TEST EQUIP>=$25K

SPECIAL TEST EQUIP<$25K

AGENCY PECULIAR>=$25K

AGENCY PECULIAR<$25K

MATERIAL>=$25K (CUMULATIVE)

PROPERTY UNDER MFR>=$25K

PROPERTY UNDER MFR<$25K

	SIGNED BY:		DATE SIGNED:


Report of Government Owned, Contractor Held Property		ATTACHMENT 8

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

a. The estimated cost of this contract is [***].

c. The Government’s obligation, represented by the sum of the estimated cost plus fixed fee, is [***].

e. It is estimated that the amount currently allotted will cover performance of the contract through September 29, 2004.

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

g. Future increments to be allotted to this contract are estimated as follows:

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Special rearrangement or alteration of facilities;

(4) Travel to attend general scientific meetings;

(5) Foreign travel - See Paragraph b.(2) below;

(6) Consultant costs;

(7) Subcontracts;

(8) Patient care costs;

b. Travel Costs

(1) Travel

(a) Total expenditures for 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 fur all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

a. Subcontract

b. Subcontract

c. Subcontract

d. Subcontract

5

e. Subcontract

f. Subcontract

g. Ceilings

(1) In no event shall the final amount reimbursable for the Overhead R&D Burn Rate using a base of Scientific Labor exceed a ceiling of 99% for the entire performance period of this contract.

(2) In no event shall the final amount reimbursable for Labor Overhead using a base of Direct Scientific Labor, plus R&D Burn on scientific labor, plus Direct Project Management Labor exceed a ceiling of 66% for the entire performance period of this contract.

(3) In no event shall the final amount reimbursable for Fringe Benefits exceed a ceiling of 38% for the entire performance period of this contract.

(5) This is authorization to charge as a direct cost to the contract a daily cost not to exceed [***] per day for office leasing space for the first year of the contract in a total amount not to exceed a ceiling of [***].

(7) The Contractor shall complete all work in accordance with the Statement of Work, terms and conditions of this contracts.

h. Contract Milestones

i. Scientific Meetings

j. Protocol Approvals

b. 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.

k. Subcontractor Estimated Expenditures

l. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

(1) The contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

(a) Direct Labor- List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

(b) Fringe Benefits - Cite rate and amount

(c) Overhead - Cite rate and amount

(d) Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

(e) Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

(f) Subcontracts - Attach subcontractor invoice(s).

(g) Equipment - Cite authorization and amount.

(h) Total Cost

(i) Fixed Fee

(j) Total CPFF

n. Understanding regarding FAR 52.222-36

o. Understanding regarding FAR 52.222-37

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

ARTICLE C.2. REPORTING REQUIREMENTS

b. Technical Reports

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

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

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

11

(5) This is authorization to charge as a direct cost to the contract a daily cost not to exceed [] per day for office leasing space for the first year of the contract in a total amount not to exceed a ceiling of [].