Vaxgen




	



[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES ACT OF 1934, AS AMENDED. 



EXHIBIT 10.47 



      OMB Approval
        2700-0042  









	
       

        AWARD/CONTRACT 

    	
      1. THIS CONTRACT
        IS A RATED ORDER 

             UNDER
        DPAS (15 CFR 350) 

    	RATING
      

           N/A
      	 	
      PAGE OF PAGES

                  1
                   31 

    
	
      2. CONTRACT (Proc.
        Inst. Ident.) NO. 

    	
      3. EFFECTIVE DATE
        

    	
      4. REQUISITION/PURCHASE
        REQUEST/PROJECT NO. 

    
	
           N01-AI-30053
        

    	
           September
        30, 2003 

    	
           VR076
        

    
	
      5. ISSUED BY                                         CODE
        

    	
                          2668-30053
        

    	
      6. ADMINISTERED BY
        (If other than Item 6)                    CODE
        

      	  
	
                National
        Institutes of Health

                  Contract Management
        Branch, NIAID

                  Room 2230

                  6700-B Rockledge
        Dr., MSC 7612

                  Bethesda,
        Maryland 20892-7612 

    	
      DMID-VR 

      RFP NIH-NIAID-DMID-03-29
        

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

    	
      8. DELIVERY 

    
	
      

        VaxGen, Inc. 

        1000 Marina Blvd. Ste. 200 

        Brisbane, CA 94005-1841 

    	
      o
         FOB ORIGIN   x
        OTHER (See below) 

                                                               FOB
        Destination 

    
	
      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                                                    
        CODE 

    	
       N/A 

    	
      12.
        PAYMENT WILL BE MADE BY                                                     CODE
        

    	
       N/A 

    
	
      Article F.1. 

    	  	
      See Article G.3.
        

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

      o
        10 U.S.C. 2304(c)(  )    o
        41 U.S.C. 253(c)( ) 

    	
      14. ACCOUNTING AND
        APPROPRIATION DATA

        EIN# 1-943236309-A1                CAN#
        3 -8460924 - $34,488,440 SOCC# 25.55 

        DOC# 300N1AI30053A 

    
	
      15A.
        ITEM NO. 

    	
      15B.
        SUPPLIES/SERVICES 

    	
      15C.
        QUANTITY 

    	
      15D.
        UNIT 

    	
      15E.
        UNIT PRICE 

    	
      15F.
        AMOUNT 

    
	
      Title:
        Production and Testing of Anthrax Recombinant Protective Antigen (rPA)
        Vaccine

      Period: September
        30, 2003 through September 29, 2007

        Amount Allotted: $ 34,488,440

        Contract Type: Cost Plus Fixed Fee/Completion 

    	  	  	
       FY 03 

        FY 04 

    	
       $34,488,440 $45,798,421
        

        $ 

        $ 

        $ 

    
	
       
         15G. TOTAL AMOUNT OF CONTRACT       

    	
       $80,286,861 

    
	
      
        16. TABLE OF CONTENTS 

    
	
      (x) 

    	
      SEC.
        

    	
      DESCRIPTION
        

    	
      PAGE(S)
        

    	
      (x) 

    	
      SEC.
        

    	
      DESCRIPTION
        

    	
      PAGE(S)
        

    
	
      
        PART I - THE SCHEDULE 

    	
      
        PART II - CONTRACT CLAUSES 

    
	
      x 	
      
        A 

    	
      
        SOLICITATION/CONTRACT FORM 

    	
      
        1 

    	
      x 	
      
        I 

    	
      
        CONTRACT CLAUSES 

    	
      
        24 

    
	
      x 	
      
        B 

    	
      
        SUPPLIES OR SERVICES AND PRICE/COST 

    	
      
        4 

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

    
	
      x 	
      
        C 

    	
      DESCRIPTION/SPECS./WORK
        STATEMENT 

    	
      
        10 

    	
      x 	
      
        J 

    	
      
        LIST OF ATTACHMENTS 

    	
      30 

    
	
      x 	
      
        D 

    	
      PACKAGING AND MARKING
        

    	
      
        12 

    	
      PART IV - REPRESENTATIONS
        AND INSTRUCTIONS 

    
	
      x 	
      
        E 

    	
      INSPECTION AND ACCEPTANCE
        

    	
      
        12 

    	
      x 	
      
        K 

    	
      
        REPRESENTATIONS, CERTIFICATIONS 

        AND OTHER STATEMENTS OF OFFERORS

    	
      31

    
	
      x 	
      
        F 

    	
      DELIVERIES OR PERFORMANCE

    	
      
        12

    	
      o 	
      
        L 

    	
      
        INSTRS., CONDS., AND NOTICES TO OFFERORS

    	
       

    
	
      x  	
      
        G 

    	
      CONTRACT ADMINISTRATION
        DATA

    	
      
        14

    	
       

    	 	 	 
	
      x 	
      
        H 

    	
      SPECIAL CONTRACT REQUIREMENTS

    	
      
        17

    	
      o 	
      
        M 

    	
      
        EVALUATION FACTORS FOR AWARD

    	
       

    
	
      CONTRACTING
        OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

    
	17.
        x CONTRACTOR’S
      NEGOTIATED AGREEMENT (Contractor is required to sign this document and
      return _3__ copies to issuing office.) Contractor agrees to furnish
      and deliver all items or perform all the services set forth or otherwise
      identified above and on any continuation sheets for the consideration stated
      herein. The rights and obligations of the parties to this contract shall
      be subject to and governed by the following documents: (a) this award/contract,
      (b) the solicitation, if any, and (c) such provisions, representations,
      certifications, and specifications, as are attached or incorporated by reference
      herein. (Attachments are listed herein.)	 	
      18. 
        o AWARD (Contractor is not required to sign this document.)
        Your offer on Solicitation Number _      
        _________________________________, including the additions or changes
        made by you which additions or changes are set forth in full above, is
        hereby accepted as to the items listed above and on any 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)

    	 	20A.
      NAME OF CONTRACTING OFFICER
	
      Lance
        Gordon, CEO

    	 	
      Elizabeth Osinski

      Contracting Officer,
        CMB, NIAID, NIH 

    
	
      19B. NAME OF CONTRACTOR

      ____/s/ Lance
        Gordon_______________

                        
        (Signature
        of person authorized to sign)

    	
      19C. DATE SIGNED

      9/30/03

    	
       

    	
      20B. UNITED STATES OF
        AMERICA

      BY _/s/ Elizabeth
        Osinski__________________________

                        
        (Signature
        of Contracting Officer)

    	
      20C. DATE SIGNED

      9/30/03

    



			
	NSN
      7540-01-152-8069		26-107		STANDARD
      FORM 26	
	(REV. 4-85)		 		 	
	PREVIOUS
      EDITION UNUSABLE		Computer
      Generated		Prescribed
      by GSA	
	 		 		FAR (48
      CFR) 53.214(a)	






	


[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of
1934, as amended. 







1.  














	




SECTION B. SUPPLIES OR
SERVICES AND PRICES/COSTS 



ARTICLE B.1. BRIEF
DESCRIPTION OF SUPPLIES OR SERVICES 




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



ARTICLE B.2. ESTIMATED
COST AND FIXED FEE 










     	a.	
          The estimated cost of this contract is $73,321,334. 


          



     	b.	
The fixed fee for this contract is $6,965,527. The fixed fee shall be paid in
installments based on the negotiated milestones set forth in ARTICLE B.4.d., and
subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT
and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1.
of this contract. Payment of fixed fee shall not be made in less than monthly
increments.  


          



     	c.	
          The Government’s obligation, represented by the sum of the estimated cost
          plus fixed fee, is $80,286,861. 


          



     	d.	
          Total funds currently available for payment and allotted to this contract are
          $34,488,440 , of which $31,496,292 represents the estimated costs, and of which
          $2,992,148 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. These funds cover the start dates for Milestones 1, 2,
          3, 4, 5, 6, 7, 8, 9,14 and 16. 


          



     	e.	
          It is estimated that the amount currently allotted will cover performance of the
          contract through September 23, 2004. 


          



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


          



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


          


	 	FY
      	 	PERIOD
      	 	 	ESTIMATED
      COST 	 	 	 FIXED
      FEE 	 	 TOTAL
      AMOUNT 
	          	
      

    	     	
      

    	 	 	
      

    	 	 	
      

    	 	
      

    	 
	 	04	 	9/30/03-9/29/07	 	 	$ 41,825,042	 	 		$3,973,379	 		$45,798,421	 
	 	(These
      funds cover the start of Milestones 10, 11, 12, 13, 15 and 17) 	 






	



ARTICLE B.3. PROVISIONS

APPLICABLE TO DIRECT COSTS 




     a.     
Items Unallowable Unless Otherwise Provided  










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






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


               



          	 	(2) 	
               Special rearrangement or alteration of facilities; 


               



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


               



          	 	(4) 	
               Travel to attend general scientific meetings; 


               



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


               




	


2.  



















          	 	(6) 	
               Consultant costs; 


               



          	 	(7) 	
               Subcontracts; 


               



          	 	(8) 	
               Patient care costs; 


               



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


               



	b. 	Travel
      Costs 






		(1) 	Domestic
Travel






               	 	(a) 	
                    Total expenditures for domestic travel (transportation, lodging, subsistence,
                    and incidental expenses) incurred in direct performance of this contract shall
                    not exceed $409,495 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. 	Subcontracts
      






          	 	(1) 	 To negotiate
      a cost plus fixed fee type subcontract with Health Protection Agency (Porton
      Down) in the estimated cost of [ *] plus a fixed fee of [ * ] for a total
      cost plus fixed fee amount not to exceed 

      [ *  ] . This subcontract shall also include ceilings for the indirect
      cost rates as set forth in the Indirect Cost Rate section of this contract.
      Award of the subcontract shall not proceed and no costs may be incurred
      until receipt of the State Department Clearance and without the prior
      written approval of the Contracting Officer upon review of the supporting
      documentation and a draft subcontract as required by the Subcontracts clause
      of the General Clauses incorporated in this contract. After written approval
      of the subcontract by the Contracting Officer, a copy of the signed, approved
      subcontract shall be provided to the Contracting Officer. 


               



          	 	(2) 	
               To negotiate a cost plus fixed fee type subcontract with Battelle in the
               estimated cost of [ * ] plus a fixed fee of [ * ] for a total estimated cost
               plus fixed fee amount not to exceed [ * ]. Award of the subcontract shall not
               proceed without the prior written approval of the Contracting Officer upon
               review of the supporting documentation and a draft subcontract agreement as
               required by the Subcontracts clause of the General Clauses incorporated in this
               contract. After written approval of the subcontract by the Contracting Officer,
               a copy of the signed, approved subcontract shall be provided to the Contracting
               Officer. 


               




	


3.  

















	b. 	Indirect Cost
      Rate Ceilings 






          	 	(1) 	
               In no event shall the final amount reimbursable for the indirect costs exceed a
               ceiling rate of [ * ]% for Fringe Benefits using a base of Direct Labor for the
               entire performance period of this contract. 


               



          	 	(2) 	
               In no event shall the final amount reimbursable for Technical Labor Overhead
               using a base of Technical Direct Labor and Fringe Benefits exceed a ceiling rate
               of [ * ]% for the entire performance period of this contract. 


               



          	 	(3) 	
               In no event shall the final amount reimbursable for Manufacturing Overhead using
               a base of Manufacturing Direct Labor and Fringe Benefits exceed a ceiling rate
               of [ * ]% for the entire performance period of this contract. 


               



          	 	(4) 	
               In no event shall the final amount reimbursable for General and Administrative
               Expenses (G&A) exceed a ceiling rate of [ * ]% of Direct Labor, Technical
               Labor Overhead , Manufacturing Labor Overhead and Total Other Direct Costs for
               the entire performance period of this contract. 


               



          	 	(5) 	
               For the Health Protection Agency (HPA) Porton Down subcontract, in no event
               shall the final amount reimbursable for Labor Overhead using a base of Direct
               Labor and Fringe Benefits exceed a ceiling rate of [ * ]% for the entire
               performance period of this subcontract. In no event shall the final amount
               reimbursable for General and Administrative Expenses (G&A) using a base of
               Direct Labor, Fringe Benefits, Overhead and Total Other Direct Costs exceed a
               ceiling rate of [ * ]% for the entire period of performance of this subcontract. 


               



          	 	(6) 	
               Any costs over and above these cost ceilings in items (1) through (5) above
               shall not be reimbursed under this contract or any other Government contract,
               grant, or cooperative agreement. 


               



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


               



	c. 	 Product
      Liability Insurance as a [ * ] 






		(1) 	[ * ]







	 	
[
* ] 







	 	
[
* ] 






	d.  	Contract
Milestones 






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







	
      

    
	 
      	 	 	MILESTONES	 	 	ESTIMATED
      COST	 	 	FIXED
      FEE	 	 	TOTAL
      CPFF	 	 
	
      

    
	 	 	 	Milestones
      for VaxGen	 	 	 	 	 	 	 	 	 	 	 
	
      

    
	  1	      	 	Submit refined
      preclinical	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	testing plan
      on or before	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	12/22/03	 	 	 	 	 	 	 	 	 	 	 
	
      

    
	  2	 	 	Submit refined
      clinical testing	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	plan on or
      before 12/16/03	 	 	 	 	 	 	 	 	 	 	 
	
      

    




	




4.  

















	
      

    
	 
      	 	 	MILESTONES	 	 	ESTIMATED
      COST	 	 	FIXED
      FEE	 	 	TOTAL
      CPFF	 	 
	
      

    
	 3	 	 	Submit
      refined regulatory plan	 	 	$[ * ]	 	 	[ * ]	 	 	$[ * ]	 	 
	  	 	 	on
      or before 12/15/03	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	 4	 	 	Complete
      development and	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	validation
      of assays on or	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	before
      3/22/04	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	 5	 	 	Demonstrated
      suitability of	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	facility
      on or before 11/7/03	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	 6	 	 	Demonstrated
      tech transfer on	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	or
      before 6/9/04	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	 7	 	 	Submit
      inventory	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	storage/maintenance
      plan on or	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	before
      9/20/06	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	 8	 	 	Phase
      2 trial completed on or	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	before
      3/7/05 - Reporting to	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	NIAID
      and subsequent payment to	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	be
      broken into three distinct	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	phases:
      (1) initiation of	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	enrollment
      (first patient	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	enrolled)
      (2) Last patient out;	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	and
      (3) delivery of final	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	report
      to NIAID. Reports	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	should
      include all data	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	collected
      during the various	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	phases
      of the study. Fee for	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	this
      milestone shall be paid in	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	3
      equal installments of the	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	total
      fee for this milestone	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	based
      on the completion of	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	phases
      (1), (2), and (3) above.	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	 9	 	 	Stockpile
      manufacturing	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	feasibility
      plan on or before	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	9/20/06	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	10	 	 	Manufacture
      all bulk rPA on or	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	before
      4/2/04 and fee will be	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	paid
      after receipt of	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	Certificate
      of Analysis	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	11	 	 	Fill/Finish
      3 million doses on	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	      	 	or
      before 10/14/04 and fee will	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	be
      paid after receipt of	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	Certificate
      of Analysis	 	 	  	 	 	  	 	 	  	 	 
	
      

    
	12	 	 	Release
      of 3d cGMP lot, deliver	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	  	 	 	or
      store 3 million doses after	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	receipt
      on or before 10/19/04	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	and
      fee will be paid after	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	receipt
      of Certificate of	 	 	  	 	 	  	 	 	  	 	 
	  	 	 	Analysis	 	 	  	 	 	  	 	 	  	 	 
	
      

    




	




5.  

















	
      

    
	 
      	 	 	MILESTONES	 	 	ESTIMATED
      COST	 	 	FIXED
      FEE	 	 	TOTAL
      CPFF	 	 
	
      

    
	13	 	 	Second
      Phase 2 trial completed	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	on
      or before 6/21/06 Reporting	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	to
      NIAID and subsequent payment	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	to
      be broken into three	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	distinct
      phases: (1) initiation	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	of
      enrollment (first patient	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	enrolled)
      (2) Last patient out;	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	and
      (3) delivery of final	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	report
      to NIAID. Reports	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	should
      include all data	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	collected
      during the various	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	phases
      of the study. Fee for	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	this
      milestone shall be paid in	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	3
      equal installments of the	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	total
      fee for this milestone	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	based
      on the completion of	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	phases
      (1), (2), and (3) above.	 	 	 	 	 	 	 	 	 	 	 
	
      

    
	14	 	 	Preclinical
      studies completed	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	on
      or before 7/11/06	 	 	  	 	 	 	 	 	 	 	 
	
      

    
	15	      	 	Complete
      regulatory plan on or	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	before
      9/4/07	 	 	 	 	 	 	 	 	 	 	 
	
      

    
	16	 	 	Complete
      stability plan on or	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	before
      3/30/07 Upon completion	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	of
      1st year, 2nd year and 3rd	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	year
      of stability testing and	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	reporting,
      fee will be paid in	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	partial
      payments	 	 	 	 	 	 	 	 	 	 	 
	
      

    
	17	 	 	Complete
      inventory	 	 	$[ * ]	 	 	$[ * ]	 	 	$[ * ]	 	 
	 	 	 	storage/maintenance
      plan on or	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	before
      10/4/06	 	 	 	 	 	 	 	 	 	 	 
	
      

    





	e.  	Scientific
Meetings 






        Travel
to general scientific meetings as follows: 



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






	f.  	Protocol Approvals
      






          	 	(1) 	
               The Contractor shall not commence work on any clinical or pre-clinical protocol
               unless the Contractor has received written approval of that protocol from the
               NIAID Project Officer. The NIAID Project Officer will approve the clinical and
               pre-clinical protocols in consultation with an advisory group. It is understood
               that the clinical or pre-clinical protocols may be modified and may not be
               implemented as proposed. It is further understood that any costs incurred in the
               conduct of any clinical or pre-clinical protocol that has not received the
               written approval of the NIAID Project Officer shall not be reimbursed through
               this contract. 


               



	




6.  

















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


               



	g. 	Subcontractor
      Estimated Expenditures 






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






	h. 	Invoices
      — Cost and Personnel Reporting, and Variances from the Negotiated Budget
      






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


               



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


                    



               	 	(b) 	
                    Fringe Benefits — Cite rate and amount 


                    



               	 	(c) 	
                    Overhead — Cite rate and amount 


                    



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


                    



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


                    



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


                    



               	 	(g) 	
                    Equipment — Cite authorization and amount. 


                    



               	 	(h) 	
                    Total Cost 


                    



               	 	(i) 	
                    Fixed Fee 


                    



               	 	(j) 	
                    Total CPFF 


                    



	 	
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. 


               



	

SECTION C.
DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 



ARTICLE C.1. STATEMENT
OF WORK 











     	a.	
          Independently and not as an agent of the Government, the Contractor shall
          furnish all the necessary services, qualified personnel, material, equipment,
          and facilities, not otherwise provided by the Government as needed to accomplish
          the tasks and milestones in the Statement of Work, SECTION J, ATTACHMENT 1,
          dated September 30, 2003, attached hereto and made a part of this contract.
          Performance and expenditures under this contract will be consistent with the
          work plans, schedule and budget described in the Contractor’s initial
          proposal dated June 27, 2003,and the Final Proposal Revision dated September 8,
          2003, which includes the answers provided in Response to the Technical and
          Administrative Questions. 


          



	




ARTICLE C.2. REPORTING
REQUIREMENTS 






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









7.  


















	a.  	Technical Reports
      






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






          	 	(1) 	 Monthly
      Technical Progress Reports — On the fifteenth of each month for
      the previous calendar month, the Contractor shall submit six (6) copies
      of a Monthly Technical Progress Report, comprising five (5) copies to the
      Project Officer and one (1) copy to the Contracting Officer. Such reports
      shall include the following specific information: 


               



               	 	(a) 	
                    A cover page that lists the contract number and title, the period of performance
                    being reported, the contractor’s names and address, the author(s), and the
                    date of submission; 


                    



               	 	(b) 	
                    SECTION I — An introduction covering the purpose and scope of the contract
                    effort; 


                    



               	 	(c) 	
                    SECTION II — The report shall detail, document, and summarize the results
                    of work done during the period covered. These reports shall be in sufficient
                    detail to explain comprehensively the results achieved. The description shall
                    include pertinent data and/or graphs in sufficient detail to explain any
                    significant results achieved and preliminary conclusions resulting from analysis
                    and scientific evaluation of data accumulated to date under the project. Also to
                    be included in the report is a summary of work proposed for the next reporting
                    period. Specific requirements are set forth in the Work Statement. A summary of
                    each ongoing and completed protocol shall be submitted at this time. A monthly
                    report will not be required for the period when the final report is due.
                    Preprints and reprints of papers and abstracts shall be submitted with the
                    Annual Report. 


                    



               	 	(d) 	
                    SECTION III — Substantive performance; a description of current technical
                    or substantive performance and any problems encountered and/or which may exist
                    along with resolution or proposed corrective action. An explanation of any
                    difference between planned progress and actual progress, why the differences
                    have occurred, and if behind planned progress what corrective steps are planned. 


                    



               	 	(e) 	
                    SECTION IV — Estimated and Actual Expenses 


                    



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






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


               



          	 	(3) 	 Final
      Report — By the expiration date of the contract, the Contractor
      shall submit five (5) copies of a comprehensive Final Report, as above,
      comprising four (4) copies to the Project Officer and one (1) copy to the
      Contracting Officer. This final report shall detail, document and summarize
      the results of the entire contract work for the period covered. This report
      shall be in sufficient detail to explain comprehensively the results achieved.
      Specific requirements are set forth in the Work Statement. Preprints and
      reprints not submitted previously shall be submitted. 


               



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


               




	



8. 














	






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. 


          



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


          



	 	
FAR
Clause No. 52.246-8, INSPECTION OF RESEARCH AND DEVELOPMENT — COST REIMBURSEMENT (MAY
2001). 






	


9.  














	





SECTION F. DELIVERIES OR
PERFORMANCE ARTICLE 



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	 	Monthly Progress
      Reports	 	 	Fifteenth
      of each month	 	 
	
      

    
	 	2	 	Milestone
      Reports	 	 	Fifteenth
      of month following milestone	 	 
	 	 	 	 	 	 	completion	 	 
	
      

    
	 	3	 	Final Report	 	 	Expiration
      Date of the Contract	 	 
	
      

    
	 	4	 	Summary of
      Salient Results	 	 	With the
      Final Reports	 	 
	
      

    







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






	
      

    
	        Addressee	 	 	Deliverable
      Item	 	 	Quantity	 	 
	
      

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

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

    






	c. 	 Other
Reports/Deliverables  






        The
following are considered deliverables under this contract: 



          	 	(1) 	
               All Technical Reports, Milestone Reports, preprints, and protocols as described
               in paragraph A, above. These deliverables are due as indicated. 


               



          	 	(2) 	
               All milestones indicated in the Statement of Work. 


               



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






	



10.  














	




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



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



FEDERAL ACQUISITION REGULATION (48
CFR CHAPTER 1) CLAUSE: 



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



SECTION G. CONTRACT
ADMINISTRATION DATA 



ARTICLE G.1. ARTICLE
G.1. PROJECT OFFICER 



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












	 	
Ed Nuzum DVM, PhD       
Office of Biodefense Research Affairs (OBRA)/DMID/NIAID/NIH

      Mail Stop Code 6604       
6610 Rockledge Drive, Room 5117       
Bethesda, MD
20892-6604 
      301-402-8603, 301-402-4197     
  301-480-1263 (fax)        
301-461-8279
(cell)       
enuzum@niaid.nih.gov 






	 	
Eileen Flynn, Co-Project Officer       
Office of Biodefense Research Affairs
(OBRA)/DMID/NIAID/NIH      
 Mail Stop Code 7630       
6610 Rockledge Drive, Room 5002

      Bethesda, MD 20892-7630       
Phone: (301) 451-6737       
Fax: (301) 480-1263

      Email: eflynn@niaid.nih.gov 






	


The Project Officer is responsible
for: (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. 



The Contracting Officer hereby
delegates the Project Officer as the Contracting Officer’s authorized representative
responsible for signing software license agreements issued as a result of this contract. 



The Government may unilaterally
change its Project Officer designation. 



ARTICLE G.2. KEY
PERSONNEL  



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






11.  

















	                           Name	 	 	Title	 	 
	 	 	 	 	 	 
	                           Carmen
      Betancourt, MS, MBA	 	 	Principal
      Investigator	 	 
	                           Marc
      Gurwith, MD	 	 	 	 	 
	                           Lynne
      Deans	 	 	 	 	 






	


ARTICLE G.3. INVOICE
SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACTFINANCIAL 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: 











	 	
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. 







12.  














	





ARTICLE G.5. GOVERNMENT
PROPERTY 










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







	

Requests for information regarding
property under this contract should be directed to the following office: 










	 	
Division
of Personal Property Services, NIH
 6011 Building, Suite 637 
6011 EXECUTIVE BLVD MSC 7670

BETHESDA MD 20852-7670
 (301) 496-6466  






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






	


ARTICLE G.6. POST AWARD
EVALUATION OF CONTRACTOR PERFORMANCE 










	a.  	Contractor
Performance Evaluations  






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






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







	


13.  














	




SECTION H. SPECIAL
CONTRACT REQUIREMENTS 



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



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



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



ARTICLE H.2. HUMAN
SUBJECTS 



RESEARCH INVOLVING HUMAN SUBJECTS
SHALL NOT BE CONDUCTED UNDER THIS CONTRACT UNTIL THE PROTOCOL DEVELOPED IN PHASE II HAS
BEEN APPROVED BY NIAID, WRITTEN NOTICE OF SUCH APPROVAL HAS BEEN PROVIDED BY THE
CONTRACTING OFFICER, AND THE CONTRACTOR HAS PROVIDED TO THE CONTRACTING OFFICER A PROPERLY
COMPLETED “PROTECTION OF HUMAN SUBJECTS ASSURANCE IDENTIFICATION/IRB
CERTIFICATION/DECLARATION OF EXEMPTION”, FORM OMB NO. 0990-0263 (FORMERLY OPTIONAL
FORM 310) CERTIFYING IRB REVIEW AND APPROVAL OF THE PROTOCOL. THE HUMAN SUBJECT
CERTIFICATION CAN BE MET BY SUBMISSION OF THE CONTRACTOR’S SELF DESIGNATED FORM,
PROVIDED THAT IT CONTAINS THE INFORMATION REQUIRED BY THE “PROTECTION OF HUMAN
SUBJECTS ASSURANCE IDENTIFICATION/IRB CERTIFICATION/DECLARATION OF EXEMPTION”, FORM
OMB NO. 0990-0263 (FORMERLY OPTIONAL FORM 310). 



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



NIH policy requires education on the
protection of human subject participants for all investigators receiving NIH contract
awards for research involving human subjects. For a complete description of the NIH Policy
announcement on required education in the protection of human subject participants, the
contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5,
2000 at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.    
          The information below is a summary of the NIH Policy Announcement: 



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



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







14.  














	





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



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



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



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



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



The Contractor must comply with the
NIH Policy cited in these NIH Announcements, the NIAID Clinical Terms of Award
(http://www.niaid.nih.gov/ncn/clinical/default_human.htm), and any other data and safety
monitoring requirements found elsewhere in this contract.  



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



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



ARTICLE H.5. HUMAN
MATERIALS 



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



ARTICLE H.6. CONTINUED
BAN ON FUNDING OF HUMAN EMBRYO RESEARCH 











	a. 	Pursuant
to Public Law(s) cited in paragraph b., below, NIH is prohibited from           using
appropriated funds to support human embryo research. Contract funds may           not be
used for (1) the creation of a human embryo or embryos for research           purposes;
or (2) research in which a human embryo or embryos are destroyed,           discarded, or
knowingly subjected to risk of injury or death greater than that           allowed for
research on fetuses in utero under 45 CFR 46.208(a)(2) and Section           498(b) of
the Public Health Service Act (42 U.S.C. 289g(b)). The term           “human embryo
or embryos” includes any organism, not protected as a           human subject under
45 CFR 46 as of the date of the enactment of this Act, that           is derived by
fertilization, parthenogenesis, cloning, or any other means from           one or more
human gametes or human diploid cells. 






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





	b	Public
      Law and Section No.	 	 	Fiscal
      Year	 	 	Period
      Covered	 	 
	 
      
	
      	P.L.
      108-7, Division G, Title V-	 	 	2003	 	 	10/1/02
      - 9/30/03	 	 
	
      	General
      Provisions, Section 510	 	 	
      	 	 	
      	 	 






	


ARTICLE H.7. 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	 	 	
      	 	 	
      	 	 





	




15.  














	





ARTICLE H.8. PRIVACY ACT 



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



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



ARTICLE H.9.
INTRODUCTION OF RODENTS AND RODENT PRODUCTS 



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



ARTICLE H.10.
RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS 



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



ARTICLE H.11. 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.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	 	 
	
      	P.L.
      108-7, Division G, Title II-	 	 	2003	 	 	Salary
      Limitation	 	 
	
      	General
      Provisions, Section 204	 	 	
      	 	 	Executive
      Level I	 	 




	




16.  

















	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.) 



ARTICLE H.13.
PUBLICATION AND PUBLICITY 



The contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this
contract in any media by including an acknowledgment substantially as follows: 











	  	
“This
project has been funded in whole or in part with Federal funds from the National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department
of Health and Human Services, under Contract No. N01-AI- 30053.” 






	

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-	 	2003	 	 	10/1/02
      - 9/30/03	 
	 	General
      Provisions, Section 507	 	 	 	 	 	 






	


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



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






	


17.  

















	c.	Public
      Law and Section No.	 	 	Fiscal
      Year	 	 	Period
      Covered	 	 
	 	 	 	 	 	 	 	 	 	 
	 
      	for
      a., above: P.L. 108-7, Division G,	 	 	2003	 	 	10/1/02
      - 9/30/03	 	 
	
      	Title
      V- General Provisions, Section 503a	 	 	
      	 	 	
      	 	 
	
      	for
      b., above: P.L. 108-7, Division G,	 	 	2003	 	 	10/1/02
      - 9/30/03	 	 
	
      	Title
      V. General Provisions, Section 503b	 	 	
      	 	 	
      	 	 



	




ARTICLE H.17. OBTAINING
AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES 



Unique research resources arising
from NIH-funded research are to be shared with the scientific research community. NIH
provides guidance, entitled, “Sharing Biomedical Research Resources: Principles and
Guidelines for Recipients of NIH Research Grants and Contracts,” (Federal Register
Notice, December 23, 1999 {64 FR 72090}), concerning the appropriate terms for
disseminating and acquiring these research resources. This guidance, found at :
http://ott.od.nih.gov/NewPages/64FR72090.pdf. is intended to help contractors ensure that
the conditions they impose and accept on the transfer of research tools will facilitate
further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH
funding policy. 



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



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



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



ARTICLE H.19. SELECT
AGENT AWARDS TO FOREIGN CONTRACTORS STATUS 



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



ARTICLE H.20. OFFICE OF
HEALTH AND SAFETY - LABORATORY REGISTRATION/SELECT AGENT TRANSFER PROGRAM 



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



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



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



For possession, use and transfer of
biological agents or toxins that have been determined to have the potential to pose a
severe threat to: 1) public health and safety; 2) both human and animal health; animal
health, or animla products; and/or 3) plant health or plant products, registration
information must be submitted to the Centers for Disease Control and Prevention,
Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection
Service (APHIS), U.S. Department of Agriculture (USDA) as applicable. 







18.  














	




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



[ * ] = Certain confidential
information contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Act of 1934, as amended. 







19.  














	






PART II — CONTRACT
CLAUSES 



SECTION I. CONTRACT
CLAUSES 



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



This contract incorporates the
following clauses by reference, with the same force and effect as if they were given in
full text. Upon request, the Contracting Officer will make their full text available.
Also, the full text of a clause may be accessed electronically at this address:
http://www.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	 	 
	 	 	 	 	 	 	 	 	 
	52.215-21	 	 	Oct 1997	 	 	Requirements
      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)	 	 
	 	 	 	 	 	 	 	 




	




20.  
















	52.222-2	 	 	Jul
      1990	 	 	Payment
      for Overtime Premium (Over $100,000) (Note:

      The dollar amount in paragraph (a) of this	 	 
	
      	     	 	
      	      	 	clause
      is $0 unless otherwise specified in the contract.)	 	 
	 	 	 	 	 	 	 	 	 
	52.222-3	 	 	Jun
      2003	 	 	Convict
      Labor 52.222-26 Apr 2002 Equal Opportunity	 	 
	 	 	 	 	 	 	 	 	 
	52.222-35	 	 	Dec
      2001	 	 	Equal
      Opportunity for Special Disabled Veterans, 

      Veterans of the Vietnam Era, and Other Eligible Veterans	 	 
	 	 	 	 	 	 	 	 	 
	52.222-36	 	 	Jun
      1998	 	 	Affirmative
      Action for Workers with Disabilities	 	 
	 	 	 	 	 	 	 	 	 
	52.222-37	 	 	Dec
      2001	 	 	Employment
      Reports on Special Disabled Veterans,	 	 
	
      	 	 	
      	 	 	Veterans
      of the Vietnam Era, and Other Eligible Veterans	 	 
	 	 	 	 	 	 	 	 	 
	52.223-6	 	 	May
      2001	 	 	Drug-Free
      Workplace	 	 
	 	 	 	 	 	 	 	 	 
	52.223-14	 	 	Jun
      2003	 	 	Toxic
      Chemical Release Reporting	 	 
	 	 	 	 	 	 	 	 	 
	52.225-1	 	 	Jun
      2003	 	 	Buy
      American Act - Supplies	 	 
	 	 	 	 	 	 	 	 	 
	52.225-13	 	 	Jun
      2003	 	 	Restrictions
      on Certain Foreign Purchases	 	 
	 	 	 	 	 	 	 	 	 
	52.227-1	 	 	Jul
      1995	 	 	Authorization
      and Consent, Alternate I (Apr 1984)	 	 
	 	 	 	 	 	 	 	 	 
	52.227-2	 	 	Aug
      1996	 	 	Notice
      and Assistance Regarding Patent and

      Copyright Infringement (Over $100,000)	 	 
	 	 	 	 	 	 	 	 	 
	52.227-11	 	 	Jun
      1997	 	 	Patent
      Rights - Retention by the Contractor (Short Form)

      (Note: In accordance with FAR 27.303(a)(2),	 	 
	
      	 	 	
      	 	 	paragraph
      (f) is modified to include the requirements

      in FAR 27.303(a)(2)(I) through (iv).	 	 
	
      	 	 	
      	 	 	The
      frequency of reporting in (I) is annual.	 	 
	 	 	 	 	 	 	 	 	 
	52.227-14	 	 	Jun
      1987	 	 	Rights
      in Data - General	 	 
	 	 	 	 	 	 	 	 	 
	52.232-9	 	 	Apr
      1984	 	 	Limitation
      on Withholding of Payments	 	 
	 	 	 	 	 	 	 	 	 
	52.232-17	 	 	Jun
      1996	 	 	Interest
      (Over $100,000)	 	 
	 	 	 	 	 	 	 	 	 
	52.232-20	 	 	Apr
      1984	 	 	Limitation
      of Cost	 	 
	 	 	 	 	 	 	 	 	 
	52.232-23	 	 	Jan
      1986	 	 	Assignment
      of Claims	 	 
	 	 	 	 	 	 	 	 	 
	52.232-25	 	 	Feb
      2002	 	 	Prompt
      Payment, Alternate I (Feb 2002)	 	 
	 	 	 	 	 	 	 	 	 
	52.232-34	 	 	May
      1999	 	 	Payment
      by Electronic Funds Transfer—Other 

      Than Central Contractor Registration	 	 
	 	 	 	 	 	 	 	 	 
	52.233-1	 	 	Jul
      2002	 	 	Disputes	 	 
	 	 	 	 	 	 	 	 	 
	52.233-3	 	 	Aug
      1996	 	 	Protest
      After Award, Alternate I (Jun 1985)	 	 
	 	 	 	 	 	 	 	 	 
	52.242-1	 	 	Apr
      1984	 	 	Notice
      of Intent to Disallow Costs	 	 
	 	 	 	 	 	 	 	 	 
	52.242-3	 	 	May
      2001	 	 	Penalties
      for Unallowable Costs (Over $500,000)	 	 
	 	 	 	 	 	 	 	 	 
	52.242-4	 	 	Jan
      1997	 	 	Certification
      of Final Indirect Costs	 	 
	 	 	 	 	 	 	 	 	 
	52.242-13	 	 	Jul
      1995	 	 	Bankruptcy
      (Over $100,000)	 	 
	 	 	 	 	 	 	 	 	 
	52.243-2	 	 	Aug
      1987	 	 	Changes
      - Cost Reimbursement, Alternate V (Apr 1984)	 	 
	 	 	 	 	 	 	 	 	 
	52.244-2	 	 	Aug
      1998	 	 	Subcontracts,
      Alternate II (Aug 1998) *If written 

      consent to subcontract is required, the identified	 	 
	
      	 	 	
      	 	 	subcontracts
      are listed in ARTICLE B, Advance

      Understandings.	 	 
	 	 	 	 	 	 	 	 	 
	52.244-5	 	 	Dec
      1996	 	 	Competition
      in Subcontracting (Over $100,000)	 	 
	 	 	 	 	 	 	 	 	 
	52.245-5	 	 	Jun
      2003	 	 	Government
      Property (Cost-Reimbursement, Time 

      and Material, or Labor-Hour Contract)	 	 
	 	 	 	 	 	 	 	 	 
	52.246-23	 	 	Feb
      1997	 	 	Limitation
      of Liability (Over $100,000)	 	 
	 	 	 	 	 	 	 	 	 
	52.249-6	 	 	Sep
      1996	 	 	Termination
      (Cost-Reimbursement)	 	 
	 	 	 	 	 	 	 	 	 
	52.249-14	 	 	Apr
      1984	 	 	Excusable
      Delays 52.253-1 Jan 1991 Computer

      Generated Forms	 	 
	 	 	 	 	 	 	 	 	 
	52.253-1	 	 	Jan 1994
      	 	 	Computer Generated Forms
      	 	 





	




21.  

















	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 3	 	 
	 	 	 	 	 	 	 	 	 
	52.270-7	 	 	Jan 2001	 	 	Paperwork
      Reduction Act	 	 






	

{End of GENERAL CLAUSES FOR A
COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT — Rev. 6/2003}. 



ARTICLE I.2. AUTHORIZED
SUBSTITUTION OF CLAUSES 



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



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







	




22.  



















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






		(6) 	FAR
52.227-14, Rights in Data — General (JUNE 1987). 






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






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






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






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






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






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






		(3)	 HHSAR
352.270-9, Care of Live Vertebrate Animals (JANUARY 2001). 






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






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






		(1) 	NIH
(RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin 81-16). 






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







	


ARTICLE I.4. ADDITIONAL
FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT 





This contract incorporates the
following clauses in full text. 



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











	a. 	FAR
          Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (APRIL 2003) 






	 	
(a)     Definitions.
As used in this clause — 







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






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






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






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






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







	



23.  




















	 	(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. 







	


[ * ] = Certain confidential
information contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Act of 1934, as amended. 











	


24.  














	




PART III 



SECTION J. LIST OF
ATTACHMENTS 



The following documents are attached
and incorporated in this contract: 










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






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






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






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






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






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






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






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






	


[ * ] = Certain confidential
information contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Act of 1934, as amended. 






25.  














	





PART IV 



SECTION K.
REPRESENTATIONS AND CERTIFICATIONS 



The following documents are
incorporated by reference in this contract: 











	1. 	Representations
and Certifications, dated September 8, 2003. 






	2. 	Human
Subjects Assurance Identification Number VaxGen, Inc. FWA00001083, dated 






	3. 	Animal
Welfare Assurance Numbers —






	 	
Subcontractor Argus Research Laboratories, Inc./Charles River Labs - A3963-01       

Subcontractor Battelle Memorial Institute-Columbus - A3034-01       

Subcontractor Covance Laboratories, Inc. - A3218-01 






	


END of the SCHEDULE 
(CONTRACT) 



[ * ] = Certain confidential
information contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the

Securities Act of 1934, as amended. 







26.  














	




Statement of Work 



   Production
and Testing of Anthrax Recombinant Protective Antigen (rPA) Vaccine



Independently and not as an agent of
the Government, the Contractor shall furnish all the necessary services, qualified
personnel, material, equipment, and facilities, not otherwise provided by the Government
as needed to accomplish the tasks and milestones described below. Performance and spending
under this contract will be consistent with the work plans, schedule and budget described
in the Contractor’s initial proposal dated June 27, 2003,and the Final Proposal
Revision dated September 8, 2003, which includes the answers provided in Response to the
Technical and Administrative Questions. 



Using intellectual property to which
the company has unencumbered access and documents “freedom to operate” and
technology known to be acceptable in the production of vaccines licensed for use in the U.
S., the Contractor shall accomplish the following work associated with intermediate-scale
manufacturing and product testing: 











		(a) 	Manufacture,
formulate, fill, finish, release and deliver to the government as                single
doses, up to 3-5 x 10e6 doses of rPA anthrax vaccine from at least three
               (3) current cGMP consistency lots. This cGMP manufacturing shall be
preceded by                transfer of assay and process technologies, process
development and validation                and engineering runs sufficient to insure
production of at least three cGMP                consistency lots suitable for Phase 3
trials and acceptable to the FDA. 






		(b) 	Develop
and validate product release and characterization criteria, serological
               assays and reagents that shall ultimately support BLA submission and
product                licensure. 






		(c) 	Develop,
implement and execute accelerated and long-term stability testing                programs
that shall ensure the safety, sterility, potency and integrity of the                IND
vaccine inventory. 






		(d) 	Store,
maintain and replenish the rPA vaccine inventory, as necessary, through
               the end of this contract. 






		(e) 	Conduct
preclinical and clinical testing to assure the safety and efficacy of                the
initial and stored vaccine inventory; and to obtain data that shall
               contribute to submission of a Biologics License Application (BLA) to the
Food                and Drug Administration (FDA). Preclinical testing shall include two
               well-characterized, appropriate animal models with B. anthracis spore
aerosol                challenge to enable correlation of efficacious immune response in
animals to                immune response in man. These models shall continue to be
refined such that data                provided from future pivotal studies be adequate to
support vaccine licensure                under the animal rule. 






		(f) 	Conduct
initial Phase 2 clinical trials. 






	 	 Milestones:
      Consistent with the urgent requirement and work requirements described above,
      the Contractor will submit a proposed plan, and execute this plan to accomplish
      the following milestones. Unless otherwise agreed, all milestones will conclude
      with delivery of an acceptable final milestone report to the NIAID. 






		1. 	Milestone
      1: Within three months of contract award, refine and submit a preclinical
      testing plan to licensure that is integrated with the clinical testing
      and manufacturing plans using the most current and available information
      including consultation with DMID and FDA Center for Biologics Evaluation
      and Research (CBER). This plan shall: a) be such that effort for all animal
      studies and budget for non-aerosol animal challenge studies are “front-loaded”
      so that as much animal data as possible will be acquired within two years
      of contract award, b) in addition to safety and efficacy data in animals,
      provide for studies that demonstrate correlates of protection in two animal
      models and delineation of surrogate markers to support licensure under 21
      CFR 601.91, c) contain studies addressing both GUP and PEP. Additionally,
      to more fully characterize the complete immune response to rPA, Cell Mediated
      Immunity (CMI) responses shall also be proposed and evaluated for their
      potential as correlates of protection. Although DMID shall directly fund
      and oversee aerosol challenge studies, these studies shall be proposed by
      successful offeror(s) and reviewed and implemented as a function of collaboration
      between offeror(s) and the rPA Interagency Animal Working Group. 








	



27.  



















	 	2. 	 Milestone
      2: Within three months of contract award, refine and submit a clinical
      testing plan to licensure that is integrated with the preclinical testing
      and manufacturing plans using the most current and available information
      including consultation with DMID and CBER. Clinical trial activities performed
      as a result of this solicitation shall include Phase 2 trials to determine
      optimum dose and optimum dosing regimen. Phase 2 trials for the young, elderly
      and special populations and Phase 3 trials are not a requirement of this
      milestone. Given the duration, cost and importance of clinical trials, the
      schedule for each clinical trial must clearly indicate key events. 


               



          	 	3. 	 Milestone
      3: Within three months of contract award and using the most current
      and available information including consultation with DMID and CBER, refine
      and submit a regulatory development and support plan that is integrated
      with all testing and manufacturing activities. Activities in this plan include
      IND maintenance, verbal and written communications with CBER, and compilation
      of data and materials that will be required in the BLA. 


               




	 	4. 	 Milestone
      4: Within six months of contract award, complete development and validation
      of all assays necessary for product characterization, release and potency
      evaluation. Validation must comply with relevant FDA and ICH guidelines.
      Milestone completion shall be determined by submission of a validation report(s).
      


               



          	 	5. 	 Milestone
      5: Within six months of contract award, demonstrate to the DMID and/or
      its designee(s) that the final production facility is suitable for manufacture
      of licensable rPA vaccine. The manufacturing facility and production processes
      shall be maintained at cGMP standards throughout all manufacturing operations.
      As part of the technical proposal, the offeror must provide documentation
      of the adequacy of facilities available for increased production of vaccine.
      As required by this acquisition, the proposed manufacturing facility must
      be operated in compliance with cGMP and shall produce product of licensable
      quality. Quality Control (QC) and Quality Assurance (QA) programs must be
      in place and sufficient to ensure cGMP manufacture of rPA vaccine acceptable
      for licensure. Quality programs must be maintained at cGMP standards throughout
      all manufacturing operations. 


               




	 	6. 	 Milestone
      6: Within nine months of contract award, demonstrate to DMID and/or
      its designee(s) that all technology transfer and process development necessary
      for intermediate-scale cGMP manufacture of three million-doses of rPA vaccine
      has been completed. This process includes completion and QC/QA release of
      all necessary documentation, and completion of all process development and
      engineering runs (for manufacture and fill) in the same facility(s) to be
      used for final consistency lot production. 


               



          	 	7. 	 Milestone
      7: Within 12 months of contract award, refine and submit for DMID approval,
      a plan to maintain, test, and replenish the rPA anthrax vaccine inventory
      for the period of this contract. This milestone pertains to all activities
      required to maintain the vaccine inventory other than stability testing.
      A stability plan shall be contained in the proposal; however, the final
      stability testing plan must be that agreed to and approved by the Project
      Officer. 


               




	 	8. 	 Milestone
      8: Within 12 months of contract award, complete the first Phase 2, dose
      optimization clinical trial. Testing shall begin only after the plan and
      initial protocols are approved by the Project Officer, and suitable cGMP
      test material is available. 


               



          	 	9. 	 Milestone
      9: Within twelve months of award, provide a feasibility plan to manufacture,
      formulate, fill and finish, test, and deliver to the government up to 25
      million doses of the candidate rPA vaccine suitable for storage in a stockpile
      for emergency use. This plan shall be based on production of a stockpile
      produced from multiple, consistent, cGMP vaccine lots. The plan shall include
      proposed steps to be taken to monitor the quality and replenish the stockpile
      as needed to maintain its ready availability for emergency use under IND.
      The feasibility plan shall include: (a) details of the process to scale-up
      production of multiple lots, including data to support the approach, i.e.
      successful scale-up of similar product class or data to or from intermediate
      scales of production; (b) timeline for production and delivery of up to
      25 million doses of product; (c) strategy that will be pursued to seek a
      US license for the product and to provide continued support for maintaining
      an active government-held IND (this strategy shall be consistent with, and
      refined from, plans developed in Milestones 1-3); (d) estimates of cost/dose
      of up to 25 million doses delivered as single doses to the government for
      use, and (e) a plan to monitor and replenish the stockpile as needed in
      consultation with the managers of the Government stockpile (this plan shall
      be consistent with, and refined from, Milestone 7). 


               




	


28.  



















	 	10. 	 Milestone
      10: Within 18 months of contract award, complete manufacture and release
      of bulk drug substance from at least three cGMP consistency lots. 


               



          	 	11.
      	 Milestone
      11: Within 21 months of contract award, complete formulation, fill and
      finish of all drug product lots that shall comprise the three million single-dose
      rPA anthrax vaccine inventory. 


               




	 	12. 	 Milestone
      12: Vaccine from each consistency lot must be delivered to, or stored
      for, the government as directed immediately upon completion of drug product
      characterization and testing under GLP conditions, and release (under IND).
      Within 24 months of contract award, the entire three million-dose vaccine
      inventory shall have been delivered to, or stored for, the government as
      directed. 


               




	 	13. 	 Milestone
      13: Within 24 months of contract award, complete the second Phase 2,
      clinical trial. Testing shall begin only after the Project Officer approves
      the plan and initial protocols. 


               



          	 	14. 	 Milestone
      14: Within 36 months of contract award complete the preclinical testing
      plan delineated in Milestone 1. Each GLP study shall be initiated following
      Project Officer approval of the plan and when suitable cGMP test material
      is available. Preclinical testing shall be conducted so that as much data
      as possible is obtained during the first two years after contract award.
      


               



          	 	15.  	 Milestone
      15: Within 36 months of contract award complete the regulatory development
      and support plan delineated in Milestone 3. These activities shall begin
      following Project Officer approval of the plan. 


               



          	 	16. 	 Milestone
      16: Within 36 months of contract award complete the stability testing
      plan for drug substance and drug product. 


               



          	 	17.
      	 Milestone
      17: Within 36 months of contract award, store, maintain, test and replenish
      the vaccine inventory as needed. These activities, which do not include
      stability testing, shall begin when the vaccine inventory is completed and
      continue to the end of the contract period of performance. 


               



	 	
Meetings
and Conferences: The Contractor shall participate in regular meetings to coordinate and
oversee the contract effort as directed by the Project Officer. Such meetings may include,
but are not limited to, meetings of all contractors and subcontractors to discuss
preclinical and clinical study designs; meetings with individual contractors and other PHS
officials to discuss the technical, regulatory and ethical aspects of the program; and
meetings with NIH technical consultants to discuss technical data provided by the
contractor.  







	

[ * ] = Certain confidential
information contained in this document, marked by brackets, has been omitted and filed
separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the
Securities Act of 1934, as amended. 






29.  















	




DETAILED TABLE
  OF CONTRACT CONTENTS 









		 	PAGE
		 	
	PART
      I. — THE SCHEDULE 		1
		 	
	SECTION
      A. SOLICITATION CONTRACT FORM		1
	 	 	 
	SECTION
      B. SUPPLIES OR SERVICES AND PRICES/COSTS	 	3
	 	 	 
	      ARTICLE
      B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	 	3
	 	 	 
	      ARTICLE
      B.2. ESTIMATED COST AND FIXED FEE	 	3
	 	 	 
	      ARTICLE
      B.3. PROVISIONS APPLICABLE TO DIRECT COSTS	 	3
	 	 	 
	      ARTICLE
      B.4. ADVANCE UNDERSTANDINGS	 	4
	 	 	 
	SECTION
      C. DESCRIPTION/SPECIFICATIONS/WORK STATEMENT	 	9
	 	 	 
	      ARTICLE
      C.1. STATEMENT OF WORK	 	9
	 	 	 
	      ARTICLE
      C.2. REPORTING REQUIREMENTS	 	9
	 	 	 
	      ARTICLE
      C.3. INVENTION REPORTING REQUIREMENT	 	11
	 	 	 
	SECTION
      D. PACKAGING, MARKING AND SHIPPING	 	11
	 	 	 
	SECTION
      E. INSPECTION AND ACCEPTANCE	 	11
	 	 	 
	SECTION
      F. DELIVERIES OR PERFORMANCE ARTICLE	 	12
	 	 	 
	      ARTICLE
      F.1. DELIVERIES	 	12
	 	 	 
	      ARTICLE
      F.2. CLAUSES INCORPORATED BY REFERENCE 	 	13
	 	 	 
	SECTION
      G. CONTRACT ADMINISTRATION DATA	 	13
	 	 	 
	      ARTICLE
      G.1. PROJECT OFFICER	 	13
	 	 	 
	      ARTICLE
      G.2. KEY PERSONNEL	 	13
	 	 	 
	      ARTICLE
      G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST 

                              
            AND CONTRACT FINANCIAL REPORT	 	14
	 	 	 
	      ARTICLE
      G.4. INDIRECT COST RATES	 	14
	 	 	 
	      ARTICLE
      G.5. GOVERNMENT PROPERTY	 	15
	 	 	 
	      ARTICLE
      G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	 	15
	 	 	 
	SECTION
      H. SPECIAL CONTRACT REQUIREMENTS	 	16
	 	 	 
	      ARTICLE
      H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH 

                              
            AND DEVELOPMENT PROJECTS	 	16
	 	 	 
	      ARTICLE
      H.2. HUMAN SUBJECTS	 	16
	 	 	 
	      ARTICLE
      H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN

                              
             RESEARCH PARTICIPANTS	 	16
	 	 	 
	      ARTICLE
      H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS	 	17
	 	 	 
	      ARTICLE
      H.5. HUMAN MATERIALS	 	17
	 	 	 
	      ARTICLE
      H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH	 	17
	 	 	 
	      ARTICLE
      H.7. NEEDLE EXCHANGE	 	17
	 	 	 
	      ARTICLE
      H.8. PRIVACY ACT	 	18




	




-i- 















	


TABLE OF CONTENTS

(CONTINUED)  









		 	 	 	PAGE	 
	 	 	 	 	 	 
	      ARTICLE
      H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS	 	 	 	18	 
	 	 	 	 	 	 
	      ARTICLE
      H.10. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS	 	 	 	18	 
	 	 	 	 	 	 
	      ARTICLE
      H.11. ANIMAL WELFARE	 	 	 	18	 
	 	 	 	 	 	 
	      ARTICLE
      H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS	 	 	 	18	 
	 	 	 	 	 	 
	      ARTICLE
      H.13. PUBLICATION AND PUBLICITY	 	 	 	19	 
	 	 	 	 	 	 
	      ARTICLE
      H.14. PRESS RELEASES	 	 	 	19	 
	 	 	 	 	 	 
	      ARTICLE
      H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	 	 	 	19	 
	 	 	 	 	 	 
	      ARTICLE
      H.16. ANTI -LOBBYING	 	 	 	19	 
	 	 	 	 	 	 
	      ARTICLE
      H.17. OBTAINING AND DISSEMINATING BIOMEDICAL

             RESEARCH RESOURCES	 	 	 	20	 
	 	 	 	 	 	 
	      ARTICLE
      H.18. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH 

             TERRORISM ACTIVITIES	 	 	 	20	 
	 	 	 	 	 	 
	      ARTICLE
      H.19. SELECT AGENT AWARDS TO FOREIGN CONTRACTOR’S

             STATUS	 	 	 	20	 
	 	 	 	 	 	 
	      ARTICLE
      H.20. OFFICE OF HEALTH AND SAFETY - LABORATORY

             REGISTRATION/SELECT AGENT TRANSFER
      PROGRAM	 	 	 	20	 
	 	 	 	 	 	 
	      ARTICLE
      H.21. POSSESSION, USE AND TRANSFER OF SELECT

             BIOLOGICAL AGENTS OR TOXINS	 	 	 	20	 
	 	 	 	 	 	 
	PART II.
      — CONTRACT CLAUSES	 	 	 	22	 
	 	 	 	 	 	 
	SECTION I.
      CONTRACT CLAUSES	 	 	 	22	 
	 	 	 	 	 	 
	      ARTICLE
      I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT

             RESEARCH AND DEVELOPMENT CONTRACT
      - FAR 52.252-2, CLAUSES

             INCORPORATED BY REFERENCE(FEBRUARY
      1998)	 	 	 	22	 
	 	 	 	 	 	 
	      ARTICLE
      I.2. AUTHORIZED SUBSTITUTION OF CLAUSES	 	 	 	24	 
	 	 	 	 	 	 
	      ARTICLE
      I.3. ADDITIONAL CONTRACT CLAUSES	 	 	 	24	 
	 	 	 	 	 	 
	      ARTICLE
      I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED

            IN FULL TEXT	 	 	 	25	 
	 	 	 	 	 	 
	PART III.
      	 	 	 	27	 
	 	 	 	 	 	 
	SECTION J.
      LIST OF ATTACHMENTS	 	 	 	27	 
	 	 	 	 	 	 
	              1.
      Statement of work 				27	 
	 	 	 	 	 	 
	             2.
      Invoice/Financing Request and Contract Financial Reporting Instructions					 
	                 for
      NIH Cost-Reimbursement Type Contracts				27	 
	 	 	 	 	 	 
	             3.
      Inclusion Enrollment Report 				27	 
	 	 	 	 	 	 
	             4.
      Annual Technical Progress Report Format for Each Study				27	 
	 	 	 	 	 	 
	             5.
      Safety & Health				27	 
	 	 	 	 	 	 
	             6.
      Procurement of Certain Equipment				27	 
	 	 	 	 	 	 
	             7.
      Research Patient Care Costs				27	
	 	 	 	 	 	 
	             8.
      Report of Government-Owned, Contractor Held Property				27	
				 		
	PART IV.	 	 	 	28	 
	 	 	 	 	 	 
	SECTION K.
      REPRESENTATIONS AND CERTIFICATIONS	 	 	 	28	 
			 			
	             1.
      Representations and Certifications				28	
	 	 	 	 	 	 
	             2.
      Human Subjects Assurance Indentification Number				28	
	 	 	 	 	 	 
	             3.
      Animal Welfare Assurance Number				28	






	

[ * ] = Certain confidential information
contained in this document, marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of
1934, as amended. 






-ii-