AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350) Rating N/A PAGE OF PAGES 1 | 26

Exhibit 10.25


AWARD/CONTRACT	1.	THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350)	Rating N/A	PAGE OF PAGES 1 \| 26

2. CONTRACT (Proc Inst. Ident.) NO. N01-AI-30030	3.	EFFECTIVE DATE September 26, 2003	4. REOUISITION/PURCHASE REQUEST/PROJEOT NO. VR 071

ISSUED BY
   National Institutes of Health
   Contract Management Branch, NIAID
   Room 2230
   0000-X Xxxxxxxxx Xx., XXX 0000
   Xxxxxxxx, Xxxxxxxx 00000-0000

CODE 2668-30030

ADMINISTERED BY (If other than Item 6)
DAIDS / VR

RFP NIH-NIAID-DAIDS-03-12

CODE

7.	NAME AND ADDRESS OF CONTRACTOR (No, street, county, state and ZIP code)	8. DELIVERY
		FOB ORIGIN OTHER (see below) FOB Destination

	Progenics Pharmaceuticals, Inc. 000 Xxx Xxx Xxxx Xxxxx Xxxx Xxxxxxxxx. NY 10591	9. DISCOUNT FOR PROMPT PAYMENT N/A
		10. SUBMIT INVOICES ITEM

	CODE	FACILITY CODE	ADDRESS SHOWN IN: Art. G.3.

11.	SHIP TO/MARK FOR See Article F.1.	CODE N/A	12.	PAYMENT WILL BE MADE BY See Article G.3.	CODE N/A

13.	AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:		14.	ACCOUNTING AND APPROPRIATION DATA: EIN 1-133379479-A1;
	10 U.S.C. 2304(c) ( )	41 U.S.C. 253(c) ( )		CAN 3-8425874; $3,054,013; SOCC 25.55; DOC #300N1AI30030A


15A. ITEM NO.	15B. SUPPLIES/SERVICES	15C. QUANTITY	15D. UNIT	15E. UNIT PRICE	15F. AMOUNT

Research and Development Contract	FY'03	$3,054,013
Title: HIV Vaccine Design and Development Teams (HVDDT)	FY'04	$3,351,512
Period: September 26, 2003 through September 25, 2008	FY'05	$6,797,463
Amount Allotted: $3,054,013	FY'06	$7,503,388
Contract Type: Cost-Plus-Fixed-Fee (Completion)	FY'07	$7,855,282

15G. TOTAL AMOUNT OF CONTRACT			$28,561,658

16. TABLE OF CONTENTS


	SEC.	DESCRIPTION	PAGE(S)	SEC.	DESCRIPTION	PAGE(S)

		PART I – THE SCHEDULE			PART II – CONTRACT CLAUSES

	A	SOLICITATION/CONTRACT FORM	1	I	CONTRACT CLAUSES	20

	B	SUPPLIES OR SERVICES AND PRICE/COST	4		PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

	C	DESCRIPTION/SPECS/WORK STATEMENT	8	J	LIST OF ATTACHMENTS	25

	D	PACKAGING AND MARKING	10		PART IV – REPRESENTATIONS AND INSTRUCTIONS

	E	INSPECTION AND ACCEPTANCE	10	K	REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS	26

	F	DELIVERIES OR PERFORMANCE	11

	G	CONTRACT ADMINISTRATION DATA	12	L	INSTRS., CONDS. AND NOTICES TO OFFERORS

	H	SPECIAL CONTRACT REQUIREMENTS	15	M	EVALUATION FACTORS FOR AWARD

CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

17.

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

18.

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


19A.	NAME AND TITLE OF SIGNER (Type or print) Xxxxxx X. XxXxxxxx, Vice President	20A.	NAME OF CONTRACTING OFFICER Xxxxx X. Xxxxxxx Contracting Officer, CMB, DEA, NIAID, NIH, DHHS


19B.	NAME OF CONTRACTOR	19C. DATE SIGNED	20B.	UNITED STATES OF AMERICA	20C. DATE SIGNED
	PROGENICS PHARMACEUTICALS, INC. /s/ Xxxxxx X. XxXxxxxx (Signature of person authorized to sign)	9/24/03	By	/s/ Xxxxx X. Xxxxxxx (Signature of Contracting Officer)	9/25/03

NSN 7540-01-152-8069
PREVIOUS EDITION UNUSABLE

26-107
Computer Generated

STANDARD FORM 26 (REV. 4-85)
Prescribed by GSA
FAR (48 CFR) 53.214(a)

N01-AI-30030

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		8
		ARTICLE C.1. STATEMENT OF WORK	8
		ARTICLE C.2. REPORTING REQUIREMENTS	8
		ARTICLE C.3. INVENTION REPORTING REQUIREMENT	10

	SECTION D – PACKAGING, MARKING AND SHIPPING		10

	SECTION E – INSPECTION AND ACCEPTANCE		10

	SECTION F – DELIVERIES OR PERFORMANCE		11
		ARTICLE F.1. DELIVERIES	11
		ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE	12

	SECTION G – CONTRACT ADMINISTRATION DATA		12
		ARTICLE G.1. PROJECT OFFICER	13
		ARTICLE G.2. KEY PERSONNEL	13
		ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT	13
		ARTICLE G.4. INDIRECT COST RATES	13
		ARTICLE G.5. GOVERNMENT PROPERTY	14
		ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	14

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

PART II- CONTRACT CLAUSES			20

	SECTION I – CONTRACT CLAUSES			20
		ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT		20
		ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES		23
		ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES		23
		ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT		24

PART III				25

	SECTION J – LIST OF ATTACHMENTS			25
		1.	Statement of Work	25
		2.	Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts	25
		3.	Inclusion Enrollment Report	25
		4.	Annual Technical Progress Report Format for Each Study	25
		5.	Safety and Health	25
		6.	Research Patient Care Costs	25
		7.	Procurement of Certain Equipment	25

PART IV				26

	SECTION K – REPRESENTATIONS AND CERTIFICATIONS			26
		1.	Representations and Certifications	26
		2.	Human Subjects Assurance Identification Number	26
		3.	Animal Welfare Assurance Number	26

a.	The estimated cost of this contract is $26,944,960.

b.	The fixed fee for this contract is $1,616,698. The fixed fee shall be paid in installments based on negotiated milestones set forth in Article B.4.e. and subject to withholding provisions of the clauses ALLOWABLE COST AND PAYMENT AND FIXED FEE Referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c.	The Government’s obligation, represented by the sum of the estimated cost plus fixed fee, is $28,561,658.

d.	Total funds currently available for payment and allotted to this contract are $3,054,013, of which $2,881,144, represents the estimated costs, and of which $172,869 represents the fixed fee. 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 25, 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	09/26/04 – 09/25/05	$3,161,804	$189,708	$3,351,512
05	09/26/05 – 09/25/06	$6,412,701	$384,762	$6,797,463
06	09/26/06 – 09/25/07	$7,078,668	$424,720	$7,503,388
07	09/26/07 – 09/25/08	$7,410,643	$444,639	$7,855,282

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;

	(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)	Domestic Travel

		(a)	Total expenditures for domestic travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract shall not exceed $26,387 without the prior written approval of the Contracting Officer.

		(b)	The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

	(2)	Foreign Travel

		Requests for foreign travel must be submitted at least six weeks in advance and shall contain the following: (a) meeting(s) and place(s) to be visited, with costs and dates; (b) name(s) and title(s) of Contractor personnel to travel and their functions in the contract project; (c) contract purposes to be served by the travel; (d) how travel of contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of NIH contract funds; (e) how such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and (f) what additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

ARTICLE B.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.	Confidential Treatment of Sensitive Information

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

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

b.	Subcontracts

	(1)	To negotiate a cost-reimbursenent type subcontract with Weill Medical College of Cornell University for an amount not to exceed $2,153,159. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the draft subcontract. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

	(2)	To negotiate a cost-reimbursement type subcontract with the Tulane Regional Primate Research Center for an amount not to exceed $1,685,605. Award of the subcontract shall not proceed without the prior written approval of the Contracting Officer upon review of the draft subcontract. After written approval of the subcontract by the Contracting Officer, a copy of the signed, approved subcontract shall be provided to the Contracting Officer.

c.	Consultants

	The total amount set aside for consultants for Years 1-5 are as follows:

	Year 1	Year 2	Year 3	Year 4	Year 5	Total
	$21,000	$21,162	$21,328	$21,499	$21,675	$106,664


Authorization to utilize consultants shall not proceed without the prior written approval of the Contracting Officer upon review of each individual consultant and a copy of each consultant agreement.

d.	Indirect Costs

	(1)	In no event shall the final amount reimbursable for indirect costs exceed a ceiling of 100% of total direct costs excluding equipment and subcontract/consortium costs except for the first $25,000 per subcontract/consortium per project period.

	(2)	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 rate.

		Any costs over and above this cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or cooperative agreement.

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

e.	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 installments based on the Project Officer’s written certification regarding the completion of these milestones as follows:

	MILESTONES	FIXED FEE
	Preclinical Vaccine Production and Screening for Phase I
1	Finalize safety and immunogenicity criteria in small animals for advancing the SOS gp140 trimer vaccines into testing in non-human primates.	Non-fundable milestone
2	Screen two current SOS gp140 trimers and control envelope proteins in a series of adjuvants for induction of neutralizing antibody in small animals.	$89,816
3	Produce multiple additional gp 140 trimers and control envelope proteins in animal-grade form. (Specifically, at least 8-10 trimers plus monomer forms.)	$89,816
4	Characterize the antigenicity and xxxxxxxxxx state of the SOS gp140 trimer vaccines.	$89,816
5	Screen additional candidates in a series of adjuvants for induction of neutralizing antibody in small animals.	$89,816
6	Pass DAIDS-contracted external audit of GMP facility.	$89,816

	MILESTONES	FIXED FEE
7	Select 5 promising SOS gp 140 trimer vaccines to test in non-human primates. Design additional optimized vaccines for synthesis and testing in small animals if required.	$89,816
8	Finalize safety and immunogenicity criteria in non-human primates for advancing the SOS gp 140 trimer vaccines into clinical development.	Non-fundable milestone
9	Screen the selected SOS gp140 trimer vaccines for production of neutralizing antibody and protection from SHIV challenge in macaques and report results to NIAID Project Officer.	$89,816
10	Select the most promising gp140 trimer vaccine that meets predetermined safety and immunogenicity criteria to advance into clinical development.	$89,816
	cGMP Vaccine Production and IND Preparation for Phase II
11	Finalize the Phase I clinical trial concept with the HVTN or other vaccine trials network approved by the NIAID Project Officer.	$89,816
12	Develop cGMP manufacturing processes for the lead SOS gp 140 trimer vaccine.	$89,816
13	Produce a GMP pilot chemical lot of the SOS gp 140 trimer vaccine for IND-enabling preclinical studies.	$89,816
14	Prepare dossier summarizing preclinical data and clinical trial design. Schedule Pre-IND meeting with CBER/FDA.	$89,816
15	Hold Pre-IND meeting with CBER/FDA.	$89,816
16	Complete IND-enabling formation, toxicology, stability and immunogenicity studies.	$89,816
17	Produce clinical lot of the SOS gp 140 trimer vaccine	$89,816
18	Finalize the Phase I clinical protocol with HVTN or other vaccine trials network approved by the NIAID Project Officer.	$89,816
19	File DMF/IND with CBER/FDA	$89,816
	Clinical Testing – Phase III
20	Initiate Phase I clinical testing of the SOS gp l40 trimer vaccine through the HVTN or other vaccine clinical trials network approved by the NIAID Project Officer.	Non-fundable milestone
21	Complete the Phase I trial.	Non-fundable milestone
22	Evaluate the safety and immunogenicity data from the Phase I trial and prepare a final study report with recommendations for further clinical development with the HVTN or other vaccine trial network approved by the Project Officer.	$89,826


f.	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)	Materials & Supplies – Include detailed breakdown when total amount is over $1,000.
		(d)	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.
		(e)	Consultant Fees – Identify individuals and amounts.
		(f)	Subcontracts – Attach subcontractor invoice(s).
		(g)	Overhead – Cite rate and amount.
		(h)	Total Cost
		(i)	Fixed Fee – Cite rate and amount
		(j)	Total CPFF

		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.

g.	GLP/GMP Compliance

	The Contractor will be audited for GMP, GLP and QC/QA capabilities within four months of contract award. Noted deficiencies shall be corrected (or addressed) within six months after issuance of the audit report.

	SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

	ARTICLE C.1. STATEMENT OF WORK

	a.	Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, dated September 26, 2003, attached hereto and made a part of this contract.

	ARTICLE C.2. REPORTING REQUIREMENTS

	The Contractor is required to formally report progress once per year, through submission of a written Technical Report, and once by holding a formal Site Visit review to be attended by appropriate NIAID contract staff and program officials, and the External Advisory Committee of the Team. The Contractor is also required to submit Goals and Milestones Achievement Reports during the contract period at appropriate times. Distribution of written reports is listed in Article F.1.

	(1)	Goals and Milestones Achievement Reports. Since the payment of contract fee portions will be tied to the accomplishment of negotiated, predetermined goals and milestones, the Contractor will submit Goals and Milestones Achievement Reports during the contract period as appropriate. The original shall be submitted to the Contracting Officer, and two (2) copies (one hard copy and a copy in a digital medium) to the Project Officer. Each report must consist of:

		1.	A cover page

		2.	Reports shall include but not be limited to the following:

			Section A – An introduction covering the goal or milestone

			Section B – A description of the results. Description shall include pertinent data and/or figures in sufficient detail to explain any significant results from analysis and scientific evaluation of data accumulated to date under the goal or milestone. When appropriate this report should detail specific requests and approvals for the conduct of human trials.

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. 52.246-9, INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM) (APRIL 1984).

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:

(2)	Clinical Trials Protocol(s). NIAID has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in NIAID-supported studies. Therefore, as described in the NIAID Clinical Terms of Award and Guidance (xxxx://xxx.xxxxx.xxx.xxx/xxx/xxxxxxxx/xxxxxxx_xxxxx.xxx), the Contractor shall develop a protocol for each clinical trial and submit it for approval by the NIAID Prevention Science Review Committee (PSRC). Protocols should include a description of the research design and protocol development including definition of objectives and approaches, planning, implementation, participant recruitment and follow-up, data collection, quality control, data and safety monitoring, final data analysis and interpretation, and publication of results. Final approval of this protocol must take place prior to participant enrollment. [For trials to be conducted through the DAIDS-sponsored HVTN, the protocol should be developed in conjunction with the HVTN.]

(3)	Annual Technical Report. By the fifteenth working day of the twelfth month of each Contract year, the Contractor shall submit Annual Technical Progress Reports as described below. The original shall be submitted to the Contracting Officer, and two (2) copies (one hard copy and one copy in a digital medium) to the Project Officer. The report should be factual and concise and consist of the following:

	1.	A cover page

	2.	Reports shall include but not be limited to the following:

			Section A – An introduction covering the purpose and scope of the contract effort

			Section B – A description of overall progress plus a separate description for each task or other logical segment of work on which effort was expended during the reporting period. The description shall include pertinent data and/or figures in sufficient detail to explain any significant results from analysis and scientific evaluation of data accumulated to date under the project. Special emphasis shall be placed on goals or milestones that were reached, or problems that were encountered that prevented reaching a scheduled goal or milestone during the reporting period and how those problems were/will be addressed, and requests and approvals to conduct human trials.

			Section C – A summary of the proposed goals and milestones for the duration of the Contract, including any proposed revisions based on results generated to date

	(4)	Annual Site Visit Review and Report. At the middle (6 month mark) of each contract year, the Contractor shall host, for NIAID contract and program staff and their External Advisory Board, a site visit review. The Contractor’s Principal Investigator and all co-investigators shall attend this meeting. An update and summary of results generated on each sub-project shall be presented by the co-investigator and/or other pertinent staff. These presentations shall include summaries of all goals or milestones reached during the review period and include a description of all problems encountered that will impact the achievement of particular goals and milestones as outlined in the Contractor’s research plan. The Principal Investigator, co-investigator and staff representing each project and sub-project shall describe goals and milestones and development objectives for the coming year. Additionally, application of the policies and procedures for monitoring the direction of specific projects shall be presented. For Contractors with foreign subcontracts, this annual site visit will also report details about approvals for manufacturing or testing that have been obtained from both the U.S. and foreign governments. A report of the plan for, and results of, this site visit shall be prepared by the Contractor and submitted to the Project Officer (in hard copy and digital medium) and the Contracting Officer (original hard copy).

	(5)	Final Technical Report. The Contractor shall submit the final report documents, two (2) copies (one hard copy and one copy in a digital medium) to the Project Officer, and the original to the Contracting Officer, which shall summarize the results of the entire contract work for the complete performance period, and shall include the specifications of the optimized AIDS vaccine product developed during the course of this Contract. These specifications shall include: 1) the identity of the vaccine strain or strains in the final product, 2) a detailed description of the manipulations used in the vaccine design, 3) a detailed description of all processes used to expand, attenuate, inactivate, or purify the final vaccine product, 4) a detailed description of any adjuvants or other potentiating agents used in the delivery of the final optimized product, 5) a detailed description of the

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

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

	c.	Inspection and acceptance will be performed at the address listed in Article G.1.

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

Item	Description	Delivery Schedule
1	Goals and Milestones Achievement Report	Quarterly after Award
2	Clinical Trials Protocol(s)	As required by the Project Officer
3	Annual Technical Report	15th day of the twelfth month of each Contract Year
4	Annual Site Visit Review	6th month of each Contract Year
5	Final Technical Report	On or before Contract Expiration

Addressee	Deliverable Item	Quantity
Contracting Officer CMB, NIAID, NIH Room 2230, MSC 7612 0000-X Xxxxxxxxx Xxxxx Xxxxxxxx, XX 00000-0000	Goals and Milestones Achievement Report Clinical Trials Protocol(s) Annual Technical Report Annual Site Visit Review Final Technical Report	— — — 1 copy 1 copy 1 copy

	Name	Title

	Xxxx X. Xxxxxx, M.D., Ph.D.	Principal Investigator, Progenics Pharmaceuticals, Inc.
	Xxxxxxx X. Xxxxx, Ph.D.	Co-PI, Progenics Pharmaceuticals, Inc.
	Xxxx X. Xxxxx, Ph.D.	Investigator, Weill Medical College of Cornell University (Subcontractor)
	Xxxxxxx X. Xxxx, Ph.D.	Investigator, Tulane Regional Primate Research Center (Subcontractor)

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

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

	(2)	Inquiries regarding payment of invoices should be directed to the designated billing office, (000) 000-0000.

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.12. 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.12. of the above referenced contract.”

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:

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:

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 proposes; 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-	2003	10/1/02 – 9/30/03
	General Provisions, Section 510

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-	2003	10/1/02 – 9/30/03
	General Provisions, Section 505

AWARD/CONTRACT 1. THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350) Rating N/A PAGE OF PAGES 1 | 26

Document Metadata

a.	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-	2003	Executive Level I
	General Provisions, Section 204

c.	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.

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.

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.

c.	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

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	Requirement for Cost or Pricing Data or Information Other Than Cost or Pricing Data – Modifications

52.216-7	Dec 2002	Allowable Cost and Payment

52.216-8	Mar 1997	Fixed Fee

52.219-8	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)(i) 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

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


HHSAR
CLAUSE
NO	DATE	TITLE

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

352.216-72	Oct 1990	Additional Cost Principles

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

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 xxxx xxxxxxxx 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 52.227-14, Rights in Data – General (JUNE 1987).

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

	(8)	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)-11, Research Patient Care Costs (4/1/84).

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.

	(c)	(1)	The Contractor shall insert the following clauses in subcontracts for commercial items:

			(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.

1.	Statement of Work, September 26, 2003, 2 pages.

2.	Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97), 6 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.	Research Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.

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

1.	Representations and Certifications, dated September 4, 2003.

2.	Progenics Pharmaceuticals, Inc., Human Subjects Assurance Identification Number FWA00003010, expires August 6, 2005.

3.	Weill Medical College of Cornell University, Human Subjects Assurance Identification Number FWA00000093, expires March 2, 2004.

4.	Tulane Regional Primate Research Center, Animal Welfare Assurance No. A3071-01, dated April 23, 2002.