Prepared and filed by St Ives Burrups




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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 
	
	
	
	

    


	5. 	ISSUED
    BY

    
        National
        Institutes of Health

           Contract Management Branch, NIAID 

         Room 2230 

         6700-B Rockledge
      Dr., MSC 7612 

         Bethesda, Maryland 20892-7612 
        	CODE
               2668-30030	6.	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.

777  Old
Saw Mill River Road

Tarrytown. 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)

    Robert A. McKinney, Vice President    

    	20A.  	NAME OF CONTRACTING OFFICER

      Nancy M. Hershey

    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/ Robert A. McKinney

        

      (Signature
    of person authorized to sign)
	9/24/03	By	/s/ Nancy M. Hershey
        

      (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


 

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N01-Al-30030

	 	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

    
	 	 	 	 	 

    


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N01-AI-30030

SECTION B – SUPPLIES OR SERVICES
      AND PRICES/COSTS 

ARTICLE B.1. BRIEF DESCRIPTION
      OF SUPPLIES OR SERVICES 

The purpose of this contract is the
    development of an efficacious vaccine against HIV for worldwide use in stemming
    the AIDS epidemic. 

ARTICLE B.2. ESTIMATED COST AND
      FIXED FEE 

	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

    


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; 


 

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N01-AI-30030

	 	(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. 
	 	 	 	 


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N01-AI-30030

	 	(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 oligomeric 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

    




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N01-AI-30030


	 	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.


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N01-AI-30030

	 	 	(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. 


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	 	(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 (http://www.niaid.nih.gov/ncn/clinical/default_human.htm),
        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 


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suggested immunization
    schedule to be used for optimal reactivity in humans, and 6) evidence that
    the vaccine product can
  be manufactured under GMP/GLP conditions for use in human vaccine trials. In
  addition, the Contractor shall indicate whether any INDs were filed in relation
  to vaccine products developed during the course of the Contract, and provide
  a description of the IND and the results of the filings. For Contractors with
  foreign subcontracts, this report shall include details concerning approvals
  for manufacturing or testing that have been obtained for or by the foreign
  subcontractors. The final report shall be submitted by the completion date
  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 NIH has developed “Interagency
    Edison,” an electronic invention reporting system. Use of Interagency Edison
    is encouraged as it streamlines the reporting process and greatly reduces
    paperwork. Access to the system is through a secure interactive Web site
    to ensure that all information submitted is protected. Interagency Edison
    and information relating to the capabilities of the system can be obtained
    from the Web (http://www.iedison.gov) or by contacting the Extramural Inventions
    and Technology Resources Branch, OPERA, NIH. 

SECTION D – PACKAGING, MARKING
      AND SHIPPING 

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

SECTION E – INSPECTION AND
      ACCEPTANCE 



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

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

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

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


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N01-AI-30030

	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).


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 duly authorized representative, of the following items in accordance
    with the stated delivery schedule: 

	a.	The items specified below as described in
        SECTION C, ARTICLE C.2. will be required to be delivered F.O.B. Destination
        as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES
        PREMISES (APRIL 1984), and in accordance
    with and by the dates specified below:
	 	 


	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


 

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


	Addressee	Deliverable Item	Quantity
	 Contracting
          Officer

  CMB, NIAID, NIH

  Room 2230, MSC 7612

  6700-B Rockledge Drive

  Bethesda, MD 20892-7612
	 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


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	Addressee	Deliverable Item	Quantity
	 Project
          Officer

  Vaccine & Prevention

  Research Program

  Division of AIDS,

  NIAID, NIH

  Room 4108, MSC 7628

  6700-B Rockledge Drive

  Bethesda, MD 20892-7628
	 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*

        1 copy*

        1 copy*


* Plus one copy on 3.5 inch, high
    density computer diskette or other digital medium approved by the Project
    Officer. 

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.l. PROJECT OFFICER

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

	 	James Bradac, Ph.D. 

Medical Officer, Preclinical Research & Development Branch 

Vaccine & Prevention Research Program 

Division of AIDS, NIAID, NIH

Room 4102, MSC 7628

6700-B Rockledge Drive 

Bethesda, MD 20892-7628 



Phone: (301) 435-3754 

Fax: (301) 402-0122

Email: jbradac@niaid.nih.gov


The Project Officer is responsible
    for: (1) monitoring the Contractor’s technical progress, including the surveillance
    and assessment of performance and recommending to the Contracting Officer
    changes in requirements; (2) interpreting the Statement of Work and any other
    technical performance requirements; (3) performing technical evaluation as
    required; (4) performing technical inspections and acceptances required by
    this contract; and (5) assisting in the resolution of technical problems
    encountered during performance. 

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

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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 individuals are considered to
    be essential to the work being performed hereunder: 

	 	Name	                    Title

	 	 	 
	 	Paul J. Maddon, M.D., Ph.D.	 Principal Investigator, Progenics
    Pharmaceuticals, Inc.
	 	William C. Olson, Ph.D.	 Co-PI,  Progenics
    Pharmaceuticals, Inc.
	 	John P. Moore, Ph.D.	 Investigator, Weill Medical College
    of Cornell University (Subcontractor)
	 	Preston A. Marx, Ph.D.	 Investigator, Tulane Regional Primate
    Research Center (Subcontractor)


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.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.”


ARTICLE G.4. INDIRECT COST RATES 

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

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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



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




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.



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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. RESTRICTION FROM
      USE OF HUMAN SUBJECTS 

NOTICE: UNDER GOVERNING REGULATIONS,
      FEDERAL FUNDS ADMINISTERED BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
      SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING HUMAN SUBJECTS, AND INDIVIDUALS
      SHALL NOT BE ENROLLED IN SUCH RESEARCH, WITHOUT PRIOR APPROVAL BY THE OFFICE
      FOR HUMAN RESEARCH PROTECTIONS (OHRP) OF AN ASSURANCE TO COMPLY WITH THE
      REQUIREMENTS OF 45 CFR 46 TO PROTECT HUMAN RESEARCH SUBJECTS. THIS RESTRICTION
      APPLIES TO ALL COLLABORATING SITES WITHOUT OHRP-APPROVED ASSURANCES, WHETHER
      DOMESTIC OR FOREIGN, AND COMPLIANCE MUST BE ENSURED BY THE AWARDEE. 

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. 

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.htm1

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

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



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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 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 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	 	 


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.

 

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ARTICLE H.9. INTRODUCTION OF RODENTS
      AND RODENT PRODUCTS 

No rodent or rodent product shall
    be delivered into the NIH, NCI environment (NIH) directly, or through collaborative
    research or holding facilities under contract to NCI 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, NCI 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 FOR 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 WITHOUT OLAW-APPROVED ASSURANCES,
      WHETHER DOMESTIC OR FOREIGN.

ARTICLE H.12. SALARY RATE LIMITATION
      LEGISLATION PROVISIONS 

	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.


*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 I 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://www.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.)

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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. N0l-AI-30030.”


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.
	 	 	 	 
	b.	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
    email address is Htips@os.dhhs.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.
	 	 	 	 
	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


 

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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. 

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N01-AI-30030

PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES 

ARTICLE 1.1. 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.arnet.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	 


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	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
	 	 	 


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	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
	 	 	 


	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 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


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

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ARTICLE I.2 AUTHORIZED SUBSTITUTION
      OF CLAUSES 

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

FAR Clause 52.219-9, SMALL BUSINESS
    SUBCONTRACTING PLAN (JANUARY 20021), and FAR Clause 52.219-16, LIQUIDATED
    DAMAGES–SUBCONTRACTING PLAN (JANUARY 1999) are deleted in their entirety.

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 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 52.227-14, 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
	 	 	 	 


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N01 AI-30030

	 	 	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.
	 	 	 	 	 


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N01 AI-30030

PART III

SECTION J – LIST OF ATTACHMENTS 

The following documents are attached
    and incorporated in 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.
	 	 


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N01-AI-30030

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.	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.


 

END of the SCHEDULE

(CONTRACT)

 

 

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STATEMENT OF WORK

Independently, and not as an agent
    of the Government, the Contractor shall furnish all the necessary services,
    qualified personnel, materials, equipment, and facilities, not otherwise
    provided by the Government under the terms of this contract, as needed to
    perform the work set forth below. 

Specifically, the Contractor shall: 

	 	1.	Identify a specific vaccine concept
        to be pursued in a well planned and
        managed, comprehensive, multidisciplinary, targeted
        development effort culminating in the production and clinical
    testing of a promising AIDS vaccine candidate.
	 	 	 	 
	 	2.	Articulate and implement a strategic
    research plan that includes.
	 	 	 	 
	 	 	a.	key development objectives and a detailed
        work plan describing proposed time
        schedules for achieving contract objectives
        and milestones, and maintaining quality
        control over the implementation and operation of
    the contract
	 	 	 	 
	 	 	b.	how decisions to proceed or not proceed will
        be made (i.e. specific qualitative
        and quantitative criteria for advancement
        of vaccine molecules or constructs through
        each stage of preclinical product development)
        including decisions to proceed or not proceed
    vis a vis human safety, immunogenicity, and testing
	 	 	 	 
	 	 	c.	plans for GMP vaccine lot production and
        for obtaining the necessary government
    and ethical approvals to proceed.
	 	 	 	 
	 	 	 	The strategic plan shall articulate how the
        Team will efficiently allocate and
        utilize the resources, redirect the
        focus (including reallocation of funds) depending
        upon the project’s changing needs and emerging
        new knowledge, obtain patent coverage and licensing
        of the resulting HIV vaccine, and what procedures
        will be followed for the resolution of potential
    legal issues that may arise.
	 	 	 	 
	 	3.	Provide a research and administrative
        team that includes all expertise needed
        for the development, optimization, pre-clinical
        and clinical testing, and production of an HIV/AIDS
        vaccine
based on the concept chosen by the Contractor.
	 	 	 	 
	 	4.	Provide infrastructure, facilities,
        and resources for performing all phases
        of this contract, including production of
        an optimized vaccine under GMP (Good Manufacturing Practices,
        as defined in the US Code of Federal Regulations – 21 CFR        §211)
        conditions, GLP (Good Laboratory Practices – 21 CFR
        §58) performance of IND-enabling preclinical animal studies,
        and GCP (Good Clinical Practices – 21 CFR §312 and ICH
        Guidelines document E6) performance of clinical studies in humans
        if clinical studies will be performed by the Contractor,
        on its own, rather than through the DAIDS HIV Vaccine
    Trials Network.
	 	 	 	 
	 	5.	Report progress according to
        Reporting Requirements (refer to the “Deliverables
    and Reporting Requirements” in this contract).


 

	Statement of Work 	ATTACHMENT 1
	(September 26, 2003)	Page 1





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	 	6.	Meet with the Project Officer
        and the External Advisory Committee
    associated with this Contract,
	 	 	 	 
	 	 	a.	The Contractor and the NIH, after Contract
        award, shall jointly establish an
        External Advisory Committee for the
        contract. The Contractor’s key personnel
        shall meet with the Project Officer and the Team’s
        External Advisory Committee at periodic intervals
        to be scheduled after contract award to review
    progress and anticipated or existing problems.
	 	 	 	 
	 	 	b.	In the middle (6 month mark) of each contract
        year, the Contractor shall host a
        site visit review for NIAID contract
        and program staff, and their External Advisory
        Committee. The Contractor’s Principal Investigator
        and all co-investigators shall attend this
        meeting. The co-investigator and/or other pertinent
        staff shall present an update and summary of
        results generated on each sub-project. These presentations
        shall include summaries of all goals or milestones
        reached during the review period and a description
        of all problems encountered that will impact
        on 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 also will report details
        about: approvals for manufacturing or testing that
        have been obtained from both the U.S. and foreign
    governments.


    

    

     

	Statement of Work 	ATTACHMENT 1
	(September 26, 2003)	Page 2







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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 be 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
    shall 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


 

	NIH(RC)-4	ATTACHMENT 2
	Rev. 5/97	Page 1







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	 	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.
	 	 
	(c)	Date Invoice/Financing Request Prepared – Insert
    the date the invoice/financing request is prepared.
	 	 
	(d)	Contract Number and Date – Insert the
    contract number and the effective date of the contract.
	 	 
	(e)	Payee’s Name and Address – Show the
        contractor's 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.


 

 

	NIH(RC)-4	ATTACHMENT 2
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	 	 	(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 $1,000 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 billed separately from domestic travel.
	 	 	 	 
	 	 	(8)	Subcontract
    Costs — List subcontractor(s) by name and amount billed.
	 	 	 	 
	 	 	(9)	Other —      List
        all other direct costs in total unless exceeding $1,000 in amount. If
        over $1,000, list cost elements and dollar amounts separately. If the
        contract contains restrictions on any cost element, that cost element
    must be listed separately.
	 	 	 	 
	 	(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.


 

	NIH(RC)-4	ATTACHMENT 2
	Rev. 5/97	Page 3







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	 	(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.


 

 

 

 

 

	NIH(RC)-4	ATTACHMENT 2
	Rev. 5/97	Page 4







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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.

 

 

	NIH(RC)-4	ATTACHMENT 2
	Rev. 5/97	Page 5







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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

            

  (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	  (b)    Invoice/Financing Request No.                                                                  

      

  (c)    Date
      Invoice Prepared                                                                              

      

  (d)    Contract
      No.                                                                                           

      

            Effective
      Date                                                                                          



  (f)
          Total Estimated Cost                                                                               

      

  (g)    Total
      Fixed Fee                                                                                       

    


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


	Expenditure Category*

        A	Cumulative

        Percentage
of
Effort/Hrs.	Incurred Cost	Cost
    at
Completion

        F	Contract
Amount

        G	Variance

        H
	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)                      
                                  (Tit1e)
 



        

     * Attach details as specified in the contract


    

	NIH(RC)-4	ATTACHMENT 2
	Rev. 5/97	Page 6







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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
	Ethnic Category	 Sex/Gender
	Females	Males	Unknown or Not Reported	Total
	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) 
	Racial Categories	Females	Males	Unknown
or Not Reported	Total
	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: October, 2001)	 







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 ANNUAL TECHNICAL PROGRESS
        REPORT
FORMAT FOR EACH STUDY

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	 







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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 this 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)	 







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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 6
	(4/1/84)	 







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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 7
	OMB Bulletin 81-16