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Exhibit 10.25

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AWARD/CONTRACT
1. THIS CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 350)  [arrow-solid.gif]                     Rating
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       1         |          26

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

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5. ISSUED BY
   National Institutes of Health
   Contract Management Branch, NIAID
   Room 2230
   6700-B Rockledge Dr., MSC 7612
   Bethesda, Maryland 20892-7612 CODE            2668-30030 6.

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

RFP NIH-NIAID-DAIDS-03-12 

CODE

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7. NAME AND ADDRESS OF CONTRACTOR (No, street, county, state and ZIP code) 8.
  DELIVERY          [emptybox.gif]  FOB ORIGIN      [tickedbox.gif]    OTHER
(see below)
                                             FOB Destination         Progenics
Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown. NY 10591 9.   DISCOUNT FOR PROMPT PAYMENT
      N/A     10. SUBMIT INVOICES                         ITEM

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

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11.

SHIP TO/MARK FOR

   See Article F.1.

CODE            N/A 12.

PAYMENT WILL BE MADE BY

See Article G.3.

CODE             N/A

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

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

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

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

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16. TABLE OF CONTENTS

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[tickedbox.gif] SEC.
DESCRIPTION
PAGE(S) [tickedbox.gif] SEC. DESCRIPTION
PAGE(S)

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PART I – THE SCHEDULE
 

 
PART II – CONTRACT CLAUSES

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A
SOLICITATION/CONTRACT FORM
1
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I
CONTRACT CLAUSES
20

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

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

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D
PACKAGING AND MARKING
10
 
 
PART IV – REPRESENTATIONS AND INSTRUCTIONS
 

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

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F
DELIVERIES OR PERFORMANCE
11
 
 
 
 

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

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[tickedbox.gif]
H
SPECIAL CONTRACT REQUIREMENTS
15
[emptybox.gif]
M
EVALUATION FACTORS FOR AWARD
 

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CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

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

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19A.  
NAME AND TITLE OF SIGNER (Type or print)
Robert A. McKinney, Vice President
20A.   NAME OF CONTRACTING OFFICER
Nancy M. Hershey
Contracting Officer, CMB, DEA, NIAID, NIH, DHHS

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19B.   NAME OF CONTRACTOR 19C. DATE SIGNED 20B.   UNITED STATES OF AMERICA 20C.
DATE SIGNED  
PROGENICS PHARMACEUTICALS, INC.
                                    /s/ Robert A. McKinney

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

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(Signature of Contracting Officer) 9/25/03

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

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N01-AI-30030

DETAILED TABLE OF CONTRACT CONTENTS

PART I- THE SCHEDULE             SECTION A – SOLICITATION/CONTRACT FORM        
    SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS 4     ARTICLE B.1. BRIEF
DESCRIPTION OF SUPPLIES OR SERVICES 4     ARTICLE B.2. ESTIMATED COST AND FIXED
FEE 4     ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS 4     ARTICLE B.4.
ADVANCE UNDERSTANDINGS 5      
 
  SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 8     ARTICLE C.1.
STATEMENT OF WORK 8     ARTICLE C.2. REPORTING REQUIREMENTS 8     ARTICLE C.3.
INVENTION REPORTING REQUIREMENT 10      
 
  SECTION D – PACKAGING, MARKING AND SHIPPING 10      
 
  SECTION E – INSPECTION AND ACCEPTANCE 10      
 
  SECTION F – DELIVERIES OR PERFORMANCE 11    
ARTICLE F.1. DELIVERIES
11    
ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE
12      
 
  SECTION G – CONTRACT ADMINISTRATION DATA 12    
ARTICLE G.1. PROJECT OFFICER
13    
ARTICLE G.2. KEY PERSONNEL
13    
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT
13    
ARTICLE G.4. INDIRECT COST RATES
13    
ARTICLE G.5. GOVERNMENT PROPERTY
14    
ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
14      
 
  SECTION H – SPECIAL CONTRACT REQUIREMENTS 15    
ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT
PROJECTS
15    
ARTICLE H.2. RESTRICTION FROM USE OF HUMAN SUBJECTS
15    
ARTICLE H.3. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
15    
ARTICLE H.4. DATA AND SAFETY MONITORING IN CLINICAL TRIALS
15    
ARTICLE H.5. HUMAN MATERIALS
16    
ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
16    
ARTICLE H.7. NEEDLE EXCHANGE
16    
ARTICLE H.8. PRIVACY ACT
16    
ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS
17    
ARTICLE H.10. ANIMAL WELFARE
17    
ARTICLE H.11. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS
17    
ARTICLE H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS
17    
ARTICLE H.13. PUBLICATION AND PUBLICITY
18    
ARTICLE H.14. PRESS RELEASES
18    
ARTICLE H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
18    
ARTICLE H.16. ANTI-LOBBYING
18    
ARTICLE H.17. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
19    
ARTICLE H.18. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORISM ACTIVITIES
19        

PART II- CONTRACT CLAUSES
20

 

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N01-Al-30030

  SECTION I – CONTRACT CLAUSES
20
   
ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT
20
   
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES
23
   
ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
23
   
ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
24
       
 
PART III
25
       
 
  SECTION J – LIST OF ATTACHMENTS
25
    1.
Statement of Work
25
    2.
Invoice/Financing Request and Contract Financial Reporting Instructions for NIH
Cost-Reimbursement Type Contracts
25
    3.
Inclusion Enrollment Report
25
    4.
Annual Technical Progress Report Format for Each Study
25
    5.
Safety and Health
25
    6.
Research Patient Care Costs
25
    7.
Procurement of Certain Equipment
25
       
 
PART IV
26
       
 
  SECTION K – REPRESENTATIONS AND CERTIFICATIONS
26
    1.
Representations and Certifications
26
    2.
Human Subjects Assurance Identification Number
26
    3.
Animal Welfare Assurance Number
26
       
 

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N01-AI-30030

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

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

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

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

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

    c.

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

    d.

Total funds currently available for payment and allotted to this contract are
$3,054,013, of which $2,881,144, represents the estimated costs, and of which
$172,869 represents the fixed fee. For further provisions on funding, see the
LIMITATION OF FUNDS clause referenced in Part II, ARTICLE I.2. Authorized
Substitutions of Clauses.

    e.

It is estimated that the amount currently allotted will cover performance of the
contract through September 25, 2004.

    f .

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

    g.

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

   

  FY
PERIOD
  ESTIMATED COST
 FIXED FEE 
TOTAL AMOUNT
              04
09/26/04 – 09/25/05
$3,161,804
$189,708
$3,351,512
  05
09/26/05 – 09/25/06
$6,412,701
$384,762
$6,797,463
  06
09/26/06 – 09/25/07
$7,078,668
$424,720
$7,503,388
  07
09/26/07 – 09/25/08
$7,410,643
$444,639
$7,855,282

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided        

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

        (1) Acquisition, by purchase or lease, of any interest in real property;
        (2) Special rearrangement or alteration of facilities;         (3)
Purchase or lease of any item of general purpose office furniture or office
equipment regardless of dollar value. (General purpose equipment is defined as
any items of personal property which are usable for purposes other than
research, such as office equipment and furnishings, pocket calculators, etc.);  
      (4) Travel to attend general scientific meetings;         (5) Foreign
travel – See Paragraph b.(2) below;         (6) Consultant costs;

 

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N01-AI-30030

  (7)

Subcontracts;

          (8) Patient care costs;           (9) Accountable Government property
(defined as both real and personal property with an acquisition cost of $1,000
or more and a life expectancy of more than two years) and “sensitive items“
(defined and listed in the Contractor’s Guide for Control of Government
Property), 1990, regardless of acquisition value.         b. Travel Costs      
    (1) Domestic Travel             (a)  Total expenditures for domestic travel
(transportation, lodging, subsistence, and incidental expenses) incurred in
direct performance of this contract shall not exceed $26,387 without the prior
written approval of the Contracting Officer.             (b) 

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

          (2) Foreign Travel             Requests for foreign travel must be
submitted at least six weeks in advance and shall contain the following: (a)
meeting(s) and place(s) to be visited, with costs and dates; (b) name(s) and
title(s) of Contractor personnel to travel and their functions in the contract
project; (c) contract purposes to be served by the travel; (d) how travel of
contractor personnel will benefit and contribute to accomplishing the contract
project, or will otherwise justify the expenditure of NIH contract funds; (e)
how such advantages justify the costs for travel and absence from the project of
more than one person if such are suggested; and (f) what additional functions
may be performed by the travelers to accomplish other purposes of the contract
and thus further benefit the project.         ARTICLE B.4. ADVANCE
UNDERSTANDINGS         Other provisions of this contract notwithstanding,
approval of the following items within the limits set forth is hereby granted
without further authorization from the Contracting Officer.         a.
Confidential Treatment of Sensitive Information          

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

          Disclosure of the information/data, in whole or in part, by the
Contractor can only be made after the Contractor receives prior written approval
from the Contracting Officer. Whenever the Contractor is uncertain with regard
to the proper handling of information/data under the contract, the Contractor
shall obtain a written determination from the Contracting Officer.         b.
Subcontracts           (1) To negotiate a cost-reimbursenent type subcontract
with Weill Medical College of Cornell University for an amount not to exceed
$2,153,159. Award of the subcontract shall not proceed without the prior written
approval of the Contracting Officer upon review of the draft subcontract. After
written approval of the subcontract by the Contracting Officer, a copy of the
signed, approved subcontract shall be provided to the Contracting Officer.      
 

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N01-AI-30030

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

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

   

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

    Authorization to utilize consultants shall not proceed without the prior
written approval of the Contracting Officer upon review of each individual
consultant and a copy of each consultant agreement.     d. Indirect Costs      
  (1) In no event shall the final amount reimbursable for indirect costs exceed
a ceiling of 100% of total direct costs excluding equipment and
subcontract/consortium costs except for the first $25,000 per
subcontract/consortium per project period.         (2) The Government is not
obligated to pay any additional amount should the final indirect cost rates
exceed these negotiated ceiling rates. In the event that the final indirect cost
rates are less than these negotiated ceiling rates, the Government’s obligation
shall be reduced to conform to the lower rate.           Any costs over and
above this cost ceiling shall not be reimbursed under this contract or any other
Government contract, grant, or cooperative agreement.         (3) The Contractor
shall complete all work in accordance with the Statement of Work, terms and
conditions of this contract.       e. Contract Milestones       The Contractor
shall complete all work in accordance with the Statement of Work and the
contract milestones set forth below. The distribution of the fixed fee shall be
paid in installments based on the Project Officer’s written certification
regarding the completion of these milestones as follows:    

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

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N01-AI-30030

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

$89,816
19 File DMF/IND with CBER/FDA
$89,816
  Clinical Testing – Phase III   20 Initiate Phase I clinical testing of the SOS
gp l40 trimer vaccine through the HVTN or other vaccine clinical trials network
approved by the NIAID Project Officer.
Non-fundable milestone
21 Complete the Phase I trial.
Non-fundable milestone
22 Evaluate the safety and immunogenicity data from the Phase I trial and
prepare a final study report with recommendations for further clinical
development with the HVTN or other vaccine trial network approved by the Project
Officer.
$89,826

        f. Invoices – Cost and Personnel Reporting, and Variances from the
Negotiated Budget           (1) The Contractor agrees to provide a detailed
breakdown on invoices of the following cost categories:             (a) Direct
Labor – List individuals by name, title/position, hourly/annual rate, level of
effort, and amount claimed.     (b) Fringe Benefits – Cite rate and amount.

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N01-AI-30030

    (c) Materials & Supplies – Include detailed breakdown when total amount is
over $1,000.     (d) Travel – Identify travelers, dates, destination, purpose of
trip, and amount. Cite COA, if appropriate. List separately, domestic travel,
general scientific meeting travel, and foreign travel.     (e) Consultant Fees –
Identify individuals and amounts.     (f) Subcontracts – Attach subcontractor
invoice(s).     (g) Overhead – Cite rate and amount.     (h) Total Cost     (i)
Fixed Fee – Cite rate and amount     (j) Total CPFF               Monthly
invoices must include the cumulative total expenses to date, adjusted (as
applicable) to show any amounts suspended by the Government.             (2) The
Contractor agrees to immediately notify the contracting officer in writing if
there is an anticipated overrun (any amount) or unexpended balance (greater than
10 percent) of the amount allotted to the contract, and the reasons for the
variance. Also refer to the requirements of the Limitation of Funds and
Limitation of Cost Clauses in the contract.           g. GLP/GMP Compliance    
       

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

            SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT            
ARTICLE C.1. STATEMENT OF WORK             a.

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

            ARTICLE C.2. REPORTING REQUIREMENTS             The Contractor is
required to formally report progress once per year, through submission of a
written Technical Report, and once by holding a formal Site Visit review to be
attended by appropriate NIAID contract staff and program officials, and the
External Advisory Committee of the Team. The Contractor is also required to
submit Goals and Milestones Achievement Reports during the contract period at
appropriate times. Distribution of written reports is listed in Article F.1.    
        (1) Goals and Milestones Achievement Reports. Since the payment of
contract fee portions will be tied to the accomplishment of negotiated,
predetermined goals and milestones, the Contractor will submit Goals and
Milestones Achievement Reports during the contract period as appropriate. The
original shall be submitted to the Contracting Officer, and two (2) copies (one
hard copy and a copy in a digital medium) to the Project Officer. Each report
must consist of:               1. A cover page               2. Reports shall
include but not be limited to the following:                 Section A – An
introduction covering the goal or milestone                 Section B – A
description of the results. Description shall include pertinent data and/or
figures in sufficient detail to explain any significant results from analysis
and scientific evaluation of data accumulated to date under the goal or
milestone. When appropriate this report should detail specific requests and
approvals for the conduct of human trials.

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N01-AI-30030

  (2) Clinical Trials Protocol(s). NIAID has a responsibility to ensure that
mechanisms and procedures are in place to protect the safety of participants in
NIAID-supported studies. Therefore, as described in the NIAID Clinical Terms of
Award and Guidance (http://www.niaid.nih.gov/ncn/clinical/default_human.htm),
the Contractor shall develop a protocol for each clinical trial and submit it
for approval by the NIAID Prevention Science Review Committee (PSRC). Protocols
should include a description of the research design and protocol development
including definition of objectives and approaches, planning, implementation,
participant recruitment and follow-up, data collection, quality control, data
and safety monitoring, final data analysis and interpretation, and publication
of results. Final approval of this protocol must take place prior to participant
enrollment. [For trials to be conducted through the DAIDS-sponsored HVTN, the
protocol should be developed in conjunction with the HVTN.]             (3)
Annual Technical Report. By the fifteenth working day of the twelfth month of
each Contract year, the Contractor shall submit Annual Technical Progress
Reports as described below. The original shall be submitted to the Contracting
Officer, and two (2) copies (one hard copy and one copy in a digital medium) to
the Project Officer. The report should be factual and concise and consist of the
following:               1. A cover page               2. Reports shall include
but not be limited to the following:                   Section A – An
introduction covering the purpose and scope of the contract effort              
    Section B – A description of overall progress plus a separate description
for each task or other logical segment of work on which effort was expended
during the reporting period. The description shall include pertinent data and/or
figures in sufficient detail to explain any significant results from analysis
and scientific evaluation of data accumulated to date under the project. Special
emphasis shall be placed on goals or milestones that were reached, or problems
that were encountered that prevented reaching a scheduled goal or milestone
during the reporting period and how those problems were/will be addressed, and
requests and approvals to conduct human trials.                   Section C – A
summary of the proposed goals and milestones for the duration of the Contract,
including any proposed revisions based on results generated to date            
  (4) Annual Site Visit Review and Report. At the middle (6 month mark) of each
contract year, the Contractor shall host, for NIAID contract and program staff
and their External Advisory Board, a site visit review. The Contractor’s
Principal Investigator and all co-investigators shall attend this meeting. An
update and summary of results generated on each sub-project shall be presented
by the co-investigator and/or other pertinent staff. These presentations shall
include summaries of all goals or milestones reached during the review period
and include a description of all problems encountered that will impact the
achievement of particular goals and milestones as outlined in the Contractor’s
research plan. The Principal Investigator, co-investigator and staff
representing each project and sub-project shall describe goals and milestones
and development objectives for the coming year. Additionally, application of the
policies and procedures for monitoring the direction of specific projects shall
be presented. For Contractors with foreign subcontracts, this annual site visit
will also report details about approvals for manufacturing or testing that have
been obtained from both the U.S. and foreign governments. A report of the plan
for, and results of, this site visit shall be prepared by the Contractor and
submitted to the Project Officer (in hard copy and digital medium) and the
Contracting Officer (original hard copy).               (5) Final Technical
Report. The Contractor shall submit the final report documents, two (2) copies
(one hard copy and one copy in a digital medium) to the Project Officer, and the
original to the Contracting Officer, which shall summarize the results of the
entire contract work for the complete performance period, and shall include the
specifications of the optimized AIDS vaccine product developed during the course
of this Contract. These specifications shall include: 1) the identity of the
vaccine strain or strains in the final product, 2) a detailed description of the
manipulations used in the vaccine design, 3) a detailed description of all
processes used to expand, attenuate, inactivate, or purify the final vaccine
product, 4) a detailed description of any adjuvants or other potentiating agents
used in the delivery of the final optimized product, 5) a detailed description
of the

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N01-AI-30030

suggested immunization schedule to be used for optimal reactivity in humans, and
6) evidence that the vaccine product can be manufactured under GMP/GLP
conditions for use in human vaccine trials. In addition, the Contractor shall
indicate whether any INDs were filed in relation to vaccine products developed
during the course of the Contract, and provide a description of the IND and the
results of the filings. For Contractors with foreign subcontracts, this report
shall include details concerning approvals for manufacturing or testing that
have been obtained for or by the foreign subcontractors. The final report shall
be submitted by the completion date of the Contract.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11 including, but
not limited to, the invention disclosure report, the confirmatory license, and
the government support certification, shall be directed to the Extramural
Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986).
In addition, one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer. The final
invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted to the
Contracting Officer within 90 days after the expiration date of the contract to
the following address:

Contracting Officer
National Institutes of Health
National Institute of Allergy and Infectious Diseases, CMB
6700-B Rockledge Drive, Room 2230
Bethesda, Maryland 20892-7612

If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the address listed above.

To assist Contractors in complying with invention reporting requirements of the
clause, the NIH has developed “Interagency Edison,” an electronic invention
reporting system. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (http://www.iedison.gov) or by
contacting the Extramural Inventions and Technology Resources Branch, OPERA,
NIH.

SECTION D – PACKAGING, MARKING AND SHIPPING

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

SECTION E – INSPECTION AND ACCEPTANCE

  a.  

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

        b.

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

        c.

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

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

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d. This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the Contracting
Officer will make its full text available.       FAR Clause No. 52.246-9,
INSPECTION OF RESEARCH AND DEVELOPMENT (SHORT FORM) (APRIL 1984).

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon
performance of the work described in Article C.1. and upon delivery and
acceptance by the Contracting Officer, or the duly authorized representative, of
the following items in accordance with the stated delivery schedule:

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

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

 

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

Addressee Deliverable Item Quantity
Contracting Officer
CMB, NIAID, NIH
Room 2230, MSC 7612
6700-B Rockledge Drive
Bethesda, MD 20892-7612
Goals and Milestones Achievement
Report
Clinical Trials Protocol(s)
Annual Technical Report
Annual Site Visit Review
Final Technical Report
—
—
—
1 copy
1 copy
1 copy

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Addressee Deliverable Item Quantity
Project Officer
Vaccine & Prevention
Research Program
Division of AIDS,
NIAID, NIH
Room 4108, MSC 7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628
Goals and Milestones Achievement
Report
Clinical Trials Protocol(s)
Annual Technical Report
Annual Site Visit Review
Final Technical Report
1 copy*
1 copy*
1 copy*
1 copy*
1 copy*

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

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

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

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

SECTION G – CONTRACT ADMINISTRATION DATA

ARTICLE G.l. PROJECT OFFICER

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

  James Bradac, Ph.D.
Medical Officer, Preclinical Research & Development Branch
Vaccine & Prevention Research Program
Division of AIDS, NIAID, NIH
Room 4102, MSC 7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628

Phone: (301) 435-3754
Fax: (301) 402-0122
Email: jbradac@niaid.nih.gov

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

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

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

The Government may unilaterally change its Project Officer designation.

ARTICLE G.2. KEY PERSONNEL

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

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

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for
NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of
this contract. The instructions and the following directions for the submission
of invoices/financing request must be followed to meet the requirements of a
“proper” payment request pursuant to FAR 32.9.

These instructions also provide for the submission of financial and personnel
reporting required by HHSAR 342.7002.

  (1) Invoices/financing requests shall be submitted as follows:           An
original and two copies to the following designated billing office:

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

  (2) Inquiries regarding payment of invoices should be directed to the
designated billing office, (301) 496-0612.       b. The Contractor shall include
the following certification on every invoice for reimbursable costs incurred
with Fiscal Year funds subject to the salary rate limitation provisions as
specified in ARTICLE H.12. of this contract. For billing purposes, certified
invoices are required for the billing period during which the applicable Fiscal
Year funds were initially charged through the final billing period utilizing the
applicable Fiscal Year funds:           “I hereby certify that the salaries
charged in this invoice are in compliance with P.L. 108-7 and ARTICLE H.12. of
the above referenced contract.”

ARTICLE G.4. INDIRECT COST RATES

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

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

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

ARTICLE G.5. GOVERNMENT PROPERTY

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

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

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations       Interim and final evaluations of
contractor performance will be prepared on this contract in accordance with FAR
42.15. The final performance evaluation will be prepared at the time of
completion of work. In addition to the final evaluation, interim evaluations
will be prepared annually to coincide with the anniversary date of the contract.
      Interim and final evaluations will be provided to the Contractor as soon
as practicable after completion of the evaluation. The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement. If agreement cannot be reached between the
parties, the matter will be referred to an individual one level above the
Contracting Officer, whose decision will be final.       Copies of the
evaluations, contractor responses, and review comments, if any, will be retained
as part of the contract file, and may be used to support future award decisions.
    b. Electronic Access to Contractor Performance Evaluations       Contractors
that have Internet capability may access evaluations through a secure Web site
for review and comment by completing the registration form that can be obtained
at the following address:

http://ocm.od.nih.gov/cdmp/cps_contractor.htm

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

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SECTION H – SPECIAL CONTRACT REQUIREMENTS

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

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

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

ARTICLE H.2. RESTRICTION FROM USE OF HUMAN SUBJECTS

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

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

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

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

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

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

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

http://grants.nih.gov/grants/guide/notice-files/not98-084.htm1
http://grants.nih.gov/grants/guide/notice-files/not99-107.html
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

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

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

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

ARTICLE H.5. HUMAN MATERIALS

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

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

a. Pursuant to Public Law(s) cited in paragraph b. , below, NIH is prohibited
from using appropriated funds to support human embryo research. Contract funds
may not be used for (1) the creation of a human embryo or embryos for research
proposes; or (2) research in which a human embryo or embryos are destroyed,
discarded, or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section
498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term “human
embryo or embryos” includes any organism, not protected as a human subject under
45 CFR 46 as of the date of the enactment of this Act, that is derived by
fertilization, parthenogenesis, cloning, or any other means from one or more
human gametes or human diploid cells.           Additionally, in accordance with
a March 4, 1997 Presidential Memorandum, Federal funds may not be used for
cloning of human beings.             b. Public Law and Section No. Fiscal Year
Period Covered           P.L. 108-7, Division G, Title V-         2003   10/1/02
– 9/30/03   General Provisions, Section 510             ARTICLE H.7. NEEDLE
EXCHANGE             a. Pursuant to Public Law(s) cited in paragraph b., below,
contract funds shall not be used to carry out any program of distributing
sterile needles or syringes for the hypodermic injection of any illegal drug.  
      b. Public Law and Section No.           Fiscal Year Period Covered        
  P.L. 108-7, Division G, Title V-           2003 10/1/02 – 9/30/03   General
Provisions, Section 505    

ARTICLE H.8. PRIVACY ACT

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

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

 

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ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

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

ARTICLE H.10. ANIMAL WELFARE

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

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

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

ARTICLE H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS

a. Pursuant to Public Law(s) cited in paragraph b., below, no NIH Fiscal Year
funds may be used to pay the direct salary of an individual through this
contract at a rate in excess of applicable amount shown for the fiscal year
covered. Direct salary is exclusive of fringe benefits, overhead, and general
and administrative expenses (also referred to as “indirect cost” or “facilities
and administrative (F&A) costs”). Direct salary has the same meaning as the term
“institutional base salary.” An individual's direct salary (or institutional
base salary) is the annual compensation that the contractor pays for an
individual's appointment whether that individual's time is spent on research,
teaching, patient care or other activities. Direct salary (or institutional base
salary) excludes any income that an individual may be permitted to earn outside
of duties to the contractor. The per year salary rate limit also applies to
individuals proposed under subcontracts. It does not apply to fees paid to
consultants. If this is a multiple year contract, it may be subject to
unilateral modifications by the Government if an individual's salary rate
exceeds any salary rate ceiling established in future HHS appropriation acts.  
      b. Public Law No. Fiscal Year Dollar Amount of
Salary Limitation*   P.L. 108-7, Division G, Title II-      2003   Executive
Level I   General Provisions, Section 204             c. Direct salaries which
will be paid with FY-03 funds are limited to the Executive Level I rate which
was in effect on the date(s) the expense was incurred.

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

LINK to EXECUTIVE LEVEL SALARIES: http://www.opm.gov/oca/PAYRATES/index.htm
(Click on “Executive Schedule” for the current Fiscal Year’s salary rate or
scroll down to the “General Schedule Salary Tables from Previous Years” to
locate the Executive Level salary rates from previous years.)

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ARTICLE H.13. PUBLICATION AND PUBLICITY

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

“This project has been funded in whole or in part with Federal funds from the
National Institute of Allergy and Infectious Diseases, National Institutes of
Health, Department of Health and Human Services, under Contract No.
N0l-AI-30030.”

ARTICLE H.14. PRESS RELEASES

a.  Pursuant to Public Law(s) cited in paragraph b., below, the contractor shall
clearly state, when issuing statements, press releases, requests for proposals,
bid solicitations and other documents describing projects or programs funded in
whole or in part with Federal money: (1) the percentage of the total costs of
the program or project which will be financed with Federal money; (2) the dollar
amount of Federal funds for the project or program; and (3) the percentage and
dollar amount of the total costs of the project or program that will be financed
by nongovernmental sources.         b. Public Law and Section No. Fiscal Year
Period Covered           P.L. 108-7, Division G, Title V-
General Provisions, Section 507
2003 10/1/02 – 9/30/03

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

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

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

ARTICLE H.16. ANTI-LOBBYING

a. Pursuant to Public Law(s) cited in paragraph c., below, contract funds shall
not be used, other than for normal and recognized executive-legislative
relationships, for publicity or propaganda purposes, for the preparation,
distribution, or use of any kit, pamphlet, booklet, publication, radio,
television, or video presentation designed to support or defeat legislation
pending before the Congress or any State legislature, except in presentation to
the Congress or any State legislature itself.         b. Contract funds shall
not be used to pay salary or expenses of the contractor or any agent acting for
the contractor, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State legislature.         c.
Public Law and Section No. Fiscal Year Period Covered           for a., above:
P.L. 108-7,  Division G, Title V-
     General Provisions, Section 503a 2003  10/1/02 – 9/30/03   for b., above:
P.L. 108-7, Division G, Title V,
     General Provisions, Section 503b  2003    10/1/02 – 9/30/03

 

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ARTICLE H.17. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

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

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

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

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

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N01-AI-30030

PART II – CONTRACT CLAUSES

SECTION I – CONTRACT CLAUSES

ARTICLE 1.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT
CONTRACT – FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

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

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

FAR                     
CLAUSE                    
NO.                     DATE                              
                    TITLE           52.202-1 Dec 2001 Definitions          
52.203-3 Apr 1984 Gratuities (Over $100,000)           52.203-5 Apr 1984
Covenant Against Contingent Fees (Over $100,000)           52.203-6 Jul 1995
Restrictions on Subcontractor Sales to the Government (Over $100,000)          
52.203-7 Jul 1995 Anti-Kickback Procedures (Over $100,000)           52.203-8
Jan 1997 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper
Activity (Over $100,000)           52.203-10 Jan 1997 Price or Fee Adjustment
for Illegal or Improper Activity (Over $100,000)           52.203-12 Jun 2003
Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
          52.204-4 Aug 2000 Printed or Copied Double-Sided on Recycled Paper
(Over $100,000)           52.209-6 Jul 1995 Protecting the Government’s
Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed
for Debarment (Over $25,000)           52.215-2 Jun 1999 Audit and Records –
Negotiation (Over $100,000)           52.215-8 Oct 1997 Order of Precedence –
Uniform Contract Format           52.215-10 Oct 1997 Price Reduction for
Defective Cost or Pricing Data           52.215-12 Oct 1997 Subcontractor Cost
or Pricing Data (Over $500,000)           52.215-14 Oct 1997 Integrity of Unit
Prices (Over $100,000)           52.215-15 Dec 1998 Pension Adjustments and
Asset Reversions           52.215-18 Oct 1997 Reversion or Adjustment of Plans
for Post-Retirement Benefits (PRB) other than Pensions           52.215-19 Oct
1997 Notification of Ownership Changes  

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52.215-21 Oct 1997 Requirement for Cost or Pricing Data or Information Other
Than Cost or Pricing Data – Modifications       52.216-7 Dec 2002 Allowable Cost
and Payment       52.216-8 Mar 1997 Fixed Fee       52.219-8 Oct 2000
Utilization of Small Business Concerns (Over $100,000)       52.219-9 Jan 2002
Small Business Subcontracting Plan (Over $500,000)       52.219-16 Jan 1999
Liquidated Damages – Subcontracting Plan (Over $500,000)       52.222-2 Jul 1990
Payment for Overtime Premium (Over $100,000) (Note: The dollar amount in
paragraph (a) of this clause is $0 unless otherwise specified in the contract.)
      52.222-3 Jun 2003 Convict Labor       52.222-26 Apr 2002 Equal Opportunity
      52.222-35 Dec 2001 Equal Opportunity for Special Disabled Veterans,
Veterans of the Vietnam Era, and Other Eligible Veterans       52.222-36 Jun
1998 Affirmative Action for Workers with Disabilities       52.222-37 Dec 2001
Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans       52.223-6 May 2001 Drug-Free Workplace      
52.223-14 Jun 2003 Toxic Chemical Release Reporting       52.225-1 Jun 2003 Buy
American Act – Supplies       52.225-13 Jun 2003 Restrictions on Certain Foreign
Purchases       52.227-1 Jul 1995 Authorization and Consent, Alternate I (Apr
1984)       52.227-2 Aug 1996 Notice and Assistance Regarding Patent and
Copyright Infringement (over $100,000)       52.227-11 Jun 1997 Patent Rights –
Retention by the Contractor (Short Form) (Note: In accordance with FAR
27.303(a)(2), paragraph (f) is modified to include the requirements in FAR
27.303(a)(2)(i) through (iv). The frequency of reporting in (i) is annual.      
52.227-14 Jun 1987 Rights in Data – General       52.232-9 Apr 1984 Limitation
on Withholding of Payments       52.232-17 Jun 1996 Interest (Over $100,000)    
  52.232-20 Apr 1984 Limitation of Cost       52.232-23 Jan 1986 Assignment of
Claims       52.232-25 Feb 2002 Prompt Payment, Alternate I (Feb 2002)      
52.232-34 May 1999 Payment by Electronic Funds Transfer–Other Than Central
Contractor Registration      

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52.233-1 Jul 2002 Disputes       52.233-3 Aug 1996 Protest After Award,
Alternate I (Jun 1985)       52.242-1 Apr 1984 Notice of Intent to Disallow
Costs       52.242-3 May 2001 Penalties for Unallowable Costs (Over $500,000)  
    52.242-4 Jan 1997 Certification of Final Indirect Costs       52.242-13 Jul
1995 Bankruptcy (Over $100,000)       52.243-2 Aug 1987 Changes – Cost
Reimbursement, Alternate V (Apr 1984)       52.244-2 Aug 1998 Subcontracts,
Alternate II (Aug 1998) *If written consent to subcontract is required, the
identified subcontracts are listed in ARTICLE B, Advance Understandings.      
52.244-5 Dec 1996 Competition in Subcontracting (Over $100,000)       52.245-5
Jun 2003 Government Property (Cost-Reimbursement, Time and Material, or
Labor-Hour Contract)       52.246-23 Feb 1997 Limitation of Liability (Over
$100,000)       52.249-6 Sep 1996 Termination (Cost-Reimbursement)      
52.249-14 Apr 1984 Excusable Delays       52.253-1 Jan 1991 Computer Generated
Forms      

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

        HHSAR     CLAUSE           NO DATE         TITLE       352.202-1 Jan
2001 Definitions – with Alternate paragraph (h) (Jan 2001)       352.216-72 Oct
1990 Additional Cost Principles       352.228-7 Dec 1991 Insurance – Liability
to Third Persons       352.232-9 Apr 1984 Withholding of Contract Payments      
352.233-70 Apr 1984 Litigation and Claims       352.242-71 Apr 1984 Final
Decisions on Audit Findings       352.270-5 Apr 1984 Key Personnel      
352.270-6 Jul 1991 Publications and Publicity       352.270-7 Jan 2001 Paperwork
Reduction Act

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

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ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES

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

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

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

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

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

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES         (1)
FAR 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997).      
    (2) FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small
Business Concerns (JANUARY 1999).             “(c) Waiver of evaluation
preference.....               [      ]     Offeror elects to waive the
evaluation preference.”           (3) FAR 52.219-23, Notice of Price Evaluation
Adjustment for Small Disadvantaged Business Concerns (JUNE 2003).            
“(b) Evaluation adjustment. (1) The Contracting Officer will evaluate offers by
adding a factor of 10% to the price of all offers, except–...”           (4) FAR
52.224-1, Privacy Act Notification (APRIL 1984).           (5) FAR 52.224-2,
Privacy Act (APRIL 1984).           (6) FAR 52.227-14, Rights in Data – General
(JUNE 1987).           (7) FAR 52.242-3, Penalties for Unallowable Costs (MAY
2001).           (8) FAR 52.247-63, Preference for U.S. Flag Air Carriers (JUNE
2003).         b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR)(48 CHAPTER 3) CLAUSES:           (1) HHSAR 352.223-70, Safety and Health
(JANUARY 2001). [This clause is provided in full text in SECTION J –
ATTACHMENTS.]           (2) HHSAR 352.270-8, Protection of Human Subjects
(JANUARY 2001).             Note: The Office for Human Research Protections
(OHRP), Office of the Secretary (OS), Department of Health and Human Services
(DHHS) is the office responsible for oversight of the Protection of Human
subjects and        

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N01 AI-30030

    should replace Office for Protection from Research Risks (OPRR), National
Institutes of Health (NIH) wherever it appears in this clause.             (3)
HHSAR 352.270-9, Care of Live Vertebrate Animals (JANUARY 2001).           c.
NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:          
  The following clauses are attached and made a part of this contract:          
  (1) NIH (RC)-7, Procurement of Certain Equipment (APRIL 1984) (OMB Bulletin
81-16).             (2) NIH(RC)-11, Research Patient Care Costs (4/1/84).      
    ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT          
This contract incorporates the following clauses in full text.           FEDERAL
ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1) CLAUSES:           a. FAR Clause
52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (APRIL 2003)             (a)
Definitions. As used in this clause–               Commercial item, has the
meaning contained in the clause at 52.202-1, Definitions.              
Subcontract, includes a transfer of commercial items between divisions,
subsidiaries, or affiliates of the Contractor or subcontractor at any tier.    
        (b) To the maximum extent practicable, the Contractor shall incorporate,
and require its subcontractors at all tiers to incorporate, commercial items or
nondevelopmental items as components of items to be supplied under this
contract.             (c) (1) The Contractor shall insert the following clauses
in subcontracts for commercial items:                 (i) 52.219-8, Utilization
of Small Business Concerns (OCT 2000) (15 U.S.C. 637(d)(2) and (3)), in all
subcontracts that offer further subcontracting opportunities. If the subcontract
(except subcontracts to small business concerns) exceeds $500,000 ($1,000,000
for construction of any public facility), the subcontractor must include
52.219-8 in lower tier subcontracts that offer subcontracting opportunities.    
            (ii) 52.222-26, Equal Opportunity (APR 2002) (E.O. 11246).          
      (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans
of the Vietnam Era, and Other Eligible Veterans (DEC 2001) (38 U.S.C. 4212(a)).
                (iv) 52.222-36, Affirmative Action for Workers with Disabilities
(JUN 1998) (29 U.S.C. 793).                 (v) 52.247-64, Preference for
Privately Owned U.S.-Flag Commercial Vessels (APR 2003) (46 U.S.C. Appx 1241 and
10 U.S.C. 2631) (flow down required in accordance with paragraph (d) of FAR
clause 52.247-64).               (2) While not required, the Contractor may flow
down to subcontracts for commercial items a minimal number of additional clauses
necessary to satisfy its contractual obligations.             (d) The Contractor
shall include the terms of this clause, including this paragraph (d), in
subcontracts awarded under this contract.          

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N01 AI-30030

PART III

SECTION J – LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

1. Statement of Work, September 26, 2003, 2 pages.     2. Invoice/Financing
Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement
Type Contracts, NIH(RC)-4, (5/97), 6 pages.     3. Inclusion Enrollment Report,
5/01 (Modified OAMP: 10/01), 1 page.     4. Annual Technical Progress Report
Format for Each Study, July 1994, 1 page.     5. Safety and Health, HHSAR Clause
352.223-70, (1/01), 1 page.     6. Research Patient Care Costs, NIH(RC)-11,
4/1/84, 1 page.     7. Procurement of Certain Equipment, NIH(RC)-7, 4/1/84, 1
page.    

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N01-AI-30030

PART IV

SECTION K – REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

1. Representations and Certifications, dated September 4, 2003.     2. Progenics
Pharmaceuticals, Inc., Human Subjects Assurance Identification Number
FWA00003010, expires August 6, 2005.     3. Weill Medical College of Cornell
University, Human Subjects Assurance Identification Number FWA00000093, expires
March 2, 2004.     4. Tulane Regional Primate Research Center, Animal Welfare
Assurance No. A3071-01, dated April 23, 2002.

 

END of the SCHEDULE
(CONTRACT)

 

 

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STATEMENT OF WORK

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

Specifically, the Contractor shall:

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

 

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

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

    

    

     

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

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

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

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

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

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

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

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

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

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

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

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

(a) Interim Invoice/Contract Financing Request – These are interim payment
requests submitted during the contract performance period.     (b) Completion
Invoice – The completion invoice is submitted promptly upon completion of the
work; but no later than one year from the contract completion date, or within
120 days after

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  settlement of the final indirect cost rates covering the year in which this
contract is physically complete (whichever date is later). The completion
invoice should be submitted when all costs have been assigned to the contract
and all performance provisions have been completed.     (c) Final Invoice – A
final invoice may be required after the amounts owed have been settled between
the Government and the contractor (e.g., resolution of all suspensions and audit
exceptions).     Preparation and Itemization of the Invoice/Financing Request:
The contractor shall furnish the information set forth in the explanatory notes
below. These notes are keyed to the entries on the sample invoice/financing
request.     (a) Designated Billing Office Name and Address – Enter the
designated billing office and address, identified in the Invoice Submission
Clause of the contract, on all copies of the invoice/financing request.     (b)
Invoice/Financing Request Number – Insert the appropriate serial number of the
invoice/financing request.     (c) Date Invoice/Financing Request Prepared –
Insert the date the invoice/financing request is prepared.     (d) Contract
Number and Date – Insert the contract number and the effective date of the
contract.     (e) Payee’s Name and Address – Show the contractor's name (as it
appears in the contract), correct address, and the title and phone number of the
responsible official to whom payment is to be sent. When an approved assignment
has been made by the contractor, or a different payee has been designated, then
insert the name and address of the payee instead of the contractor.     (f)
Total Estimated Cost of Contract – Insert the total estimated cost of the
contract, exclusive of fixed-fee. For incrementally funded contracts, enter the
amount currently obligated and available for payment.     (g) Total Fixed-Fee –
Insert the total fixed-fee (where applicable). For incrementally funded
contracts, enter the amount currently obligated and available for payment.    
(h) Billing Period – Insert the beginning and ending dates (month, day, and
year) of the period in which costs were incurred and for which reimbursement is
claimed.     (i) Incurred Cost-Current – Insert the amount billed for the major
cost elements, adjustments, and adjusted amounts for the current period.     (j)
Incurred Cost-Cumulative – Insert the cumulative amounts billed for the major
cost elements and adjusted amounts claimed during this contract.     (k) Direct
Costs – Insert the major cost elements. For each element, consider the
application of the paragraph entitled “Costs Requiring Prior Approval” on page 1
of these instructions.

 

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    (1) Direct Labor — Include salaries and wages paid (or accrued) for direct
performance of the contract. For Key Personnel, list each employee on a separate
line. List other employees as one amount unless otherwise required by the
contract.               (2) Fringe Benefits — List any fringe benefits
applicable to direct labor and billed as a direct cost. Fringe benefits included
in indirect costs should not be identified here.               (3) Accountable
Personal Property — Include permanent research equipment and general purpose
equipment having a unit acquisition cost of $1,000 or more and having an
expected service life of more than two years, and sensitive property regardless
of cost (see the DHHS Contractor’s Guide for Control of Government Property).
Show permanent research equipment separate from general purpose equipment.
Prepare and attach Form HHS-565, “Report of Accountable Property,” in accordance
with the following instructions:                 List each item for which
reimbursement is requested. A reference shall be made to the following (as
applicable):                 - The item number for the specific piece of
equipment listed in the Property Schedule.                 - The Contracting
Officer’s Authorization letter and number, if the equipment is not covered by
the Property Schedule.                 - Be preceded by an asterisk (*) if the
equipment is below the approval level.               (4) Materials and Supplies
— Include equipment with unit costs of less than $1,000 or an expected service
life of two years or less, and consumable material and supplies regardless of
amount.             (5) Premium Pay — List remuneration in excess of the basic
hourly rate.             (6) Consultant Fee — List fees paid to consultants.
Identify consultant by name or category as set forth in the contract’s Advance
Understanding or in the COA letter, as well as the effort (i.e., number of
hours, days, etc.) and rate being billed.             (7) Travel — Include
domestic and foreign travel. Foreign travel is travel outside of Canada, the
United States and its territories and possessions. However, for an organization
located outside Canada, the United States and its territories and possessions,
foreign travel means travel outside that country. Foreign travel must be billed
separately from domestic travel.             (8) Subcontract Costs — List
subcontractor(s) by name and amount billed.             (9) Other — List all
other direct costs in total unless exceeding $1,000 in amount. If over $1,000,
list cost elements and dollar amounts separately. If the contract contains
restrictions on any cost element, that cost element must be listed separately.  
        (l) Cost of Money (COM) — Cite the COM factor and base in effect during
the time the cost was incurred and for which reimbursement is claimed.

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  (m) Indirect Costs-Overhead — Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.         (n) Fixed-Fee Earned —
Cite the formula or method of computation for the fixed-fee (if any). The
fixed-fee must be claimed as provided for by the contract.         (o) Total
Amounts Claimed — Insert the total amounts claimed for the current and
cumulative periods.         (p) Adjustments — Include amounts conceded by the
contractor, outstanding suspensions, and/or disapprovals subject to appeal.    
    (q) Grand Totals         The contracting officer may require the contractor
to submit detailed support for costs claimed on one or more interim
invoices/financing requests.

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

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FINANCIAL REPORTING INSTRUCTIONS:

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

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

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

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

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

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

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

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

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

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

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

 

 

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

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SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

  (a)    Billing Office Name and Address

            NATIONAL INSTITUTES OF HEALTH
            National Institute of Allergy and Infectious Diseases
            Room 2230. MSC 7612
            6700-B Rockledge Drive
            Bethesda, MD 20892-7612
            
  (e)     Payee's Name and Address
            ABC CORPORATION
            100 Main Street
            Anywhere, USA zip code
            
Attn:    Name, Title, & Phone Number of Official to
            Whom Payment is Sent
  (b)    Invoice/Financing Request No.                                                                  

  (c)    Date Invoice
Prepared                                                                              

  (d)    Contract
No.                                                                                           

            Effective Date
                                                                                         

  (f)     Total Estimated
Cost                                                                               

  (g)    Total Fixed
Fee                                                                                       

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

Expenditure Category*
A Cumulative
Percentage of
Effort/Hrs. Incurred Cost Cost at
Completion
F Contract
Amount
G Variance
H Negotiated
B Actual
C (i) Current
D (j) Cumulative
E (k) Direct Costs:              
(1) Direct Labor
             
(2) Fringe Benefits
             
(3) Accountable property (attach HHS-565)
             
(4) Materials & Supplies
             
(5) Premium Pay
             
(6) Consultant Fees
             
(7) Travel
             
(8) Subcontracts
             
(9) Other
              Total Direct Costs               (l) Cost of Money              
(m) Overhead                     G&A               (n) Fixed Fee              
(o) Total Amount Claimed               (p) Adjustments               (q) Grand
Totals                 I certify that all payments are for appropriate purposes
and in accordance with the contract.
 
                                                                     
                                             
       (Name of Official)                      
                          (Tit1e)
 
* Attach details as specified in the contract

    

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

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

Study Title: Total Enrollment: Protocol Number: Contract Number:   

PART A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date
(Cumulative) by Ethnicity and Race Ethnic Category Sex/Gender Females Males
Unknown or Not Reported Total Hispanic or Latino         Not Hispanic or Latino
        Unknown (Individuals not reporting ethnicity)         Ethnic Category:
Total of All Subjects*         Racial Categories         American Indian/Alaska
Native         Asian         Native Hawaiian or Other Pacific Islander        
Black or African American         White         More than one race        
Unknown or not reported         Racial Categories: Total of All Subjects*      
    PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled
to Date (Cumulative) Racial Categories Females Males Unknown or Not Reported
Total American Indian or Alaska Native         Asian         Native Hawaiian or
Other Pacific Islander         Black or African American         White        
More Than One Race         Unknown or not reported         Racial Categories:
Total of Hispanics or Latinos**         *These totals must agree
**These totals must agree        

 

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

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ANNUAL TECHNICAL PROGRESS REPORT FORMAT FOR EACH STUDY

Study Title:
Date:

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

  American Indian or Alaskan Native Asian or Pacific Islander Black, not of
Hispanic Origin Hispanic White, not of Hispanic Origin Other or Unknown Total
Female               Male               Unknown               TOTAL            
 

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

 

Annual Technical Progress Report Format ATTACHMENT 4 July, 1994  

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HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001)

(a) To help ensure the protection of the life and health of all persons, and to
help prevent damage to property, the Contractor shall comply with all Federal,
State and local laws and regulations applicable to the work being performed
under this contract. These laws are implemented and/or enforced by the
Environmental Protection Agency, Occupational Safety and Health Administration
and other agencies at the Federal, State and local levels (Federal, State and
local regulatory/enforcement agencies).     (b) Further, the Contractor shall
take or cause to be taken additional safety measures as the Contracting Officer
in conjunction with the project or other appropriate officer, determines to be
reasonably necessary. If compliance with these additional safety measures
results in an increase or decrease in the cost or time required for performance
of any part of work under this contract, an equitable adjustment will be made in
accordance with the applicable “Changes” Clause set forth in this contract.    
(c) The Contractor shall maintain an accurate record of, and promptly report to
the Contracting Officer, all accidents or incidents resulting in the exposure of
persons to toxic substances, hazardous materials or hazardous operations; the
injury or death of any person; and/or damage to property incidental to work
performed under the contract and all violations for which the Contractor has
been cited by any Federal, State or local regulatory/enforcement agency. The
report shall include a copy of the notice of violation and the findings of any
inquiry or inspection, and an analysis addressing the impact these violations
may have on the work remaining to be performed. The report shall also state the
required action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame allowed
by the agency to accomplish the necessary corrective action.     (d) If the
Contractor fails or refuses to comply promptly with the Federal, State or local
regulatory/enforcement agency’s directive(s) regarding any violation(s) and
prescribed corrective action(s), the Contracting Officer may issue an order
stopping all or part of the work until satisfactory corrective action (as
approved by the Federal, State or local regulatory/enforcement agencies) has
been taken and documented to the Contracting Officer. No part of the time lost
due to any stop work order shall be subject to a claim for extension of time or
costs or damages by the Contractor.     (e) The Contractor shall insert the
substance of this clause in each subcontract involving toxic substances,
hazardous materials, or operations. Compliance with the provisions of this
clause by subcontractors will be the responsibility of the Contractor.

(End of clause)

     

 

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

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RESEARCH PATIENT CARE COSTS

(a) Research patient care costs are the costs of routine and ancillary services
provided to patients participating in research programs described in this
contract.     (b) Patient care costs shall be computed in a manner consistent
with the principles and procedures used by the Medicare Program for determining
the part of Medicare reimbursement based on reasonable costs. The Diagnostic
Related Group (DRG) prospective reimbursement method used to determine the
remaining portion of Medicare reimbursement shall not be used to determine
patient care costs. Patient care rates or amounts shall be established by the
Secretary of HHS or his duly authorized representative.     (c) Prior to
submitting an invoice for patient care costs under this contract, the contractor
must make every reasonable effort to obtain third party payment, where third
party payors (including Government agencies) are authorized or are under a legal
obligation to pay all or a portion of the charges incurred under this contract
for patient care.     (d) The contractor must maintain adequate procedures to
identify those research patients participating in this contract who are eligible
for third party reimbursement.     (e) Only those charges not recoverable from
third party payors or patients and which are consistent with the terms and
conditions of the contract are chargeable to this contract.

 

NIH(RC)-11 ATTACHMENT 6 (4/1/84)  

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PROCUREMENT OF CERTAIN EQUIPMENT

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

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

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

     

 

 

 

 

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

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