Exhibit 10.38


 


PharmAthene,
Inc.


Confidential
Materials Omitted and Submitted Separately to the


Securities
and Exchange Commission


Confidential
Portions denoted by [***]


 


Document
         

Control #A00821


 


	
  OMB Approval 2700-0042  

  



 


	
  

  AWARD/CONTRACT

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

  	
  


  	
  RATING

  N/A

  	
  PAGE    OF   PAGES

  
	
         1

  	
      59

  
	
   

  	
   

  	
   

  
	
  2   CONTRACT (Proc Inst Ident) NO

  HHSN272200800049C

  	
  3.  EFFECTIVE DATE

  September 25, 2008

  	
  4.  REQUISITION/PURCHASE
  REQUEST/PROJECT NO.

               751380

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5   ISSUED BY         CODE

  	
   

  	
  6.  ADMINISTERED BY (If other than Item 6)

  	
  CODE

  	
  N/A

  
	
  National Institutes of Health

  National Institute of Allergy and Infectious Diseases

  DEA, Office of Acquisitions

  6700-B Rockledge Drive, Room 3214, MSC 7612

  Bethesda, Maryland 20892-7612

  	
  MIDRCB-B

  

  BAA-NIH-BARDA-NIAID-DMID-AI2007007

  

  NIAID Reference No. N01-AI-80049

  	
   

  
	
   

  	
   

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

  PharmAthene, Inc.                          VIN:  1123607

  One Park Place, Suite 450

  Annapolis, MD   21401

  	
  8.  DELIVERY

  
	
  9.  DISCOUNT FOR PROMPT PAYMENT

  N/A

   

  
	
  10. SUBMIT INVOICES

  	
  ITEM

  
	
   

  	
   

  	
   

  	
   

  
	
  CODE

  	
  FACILITY CODE

  	
  ADDRESS SHOWN IN:

  	
  Art. G.3.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11. SHIP TO/MARK FOR

  	
  CODE

  	
  N/A

  	
  12. PAYMENT WILL BE MADE BY

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  
	
  Article F.2.

  	
  See Article G.3.

  
	
   

  	
   

  
	
  13. AUTHORITY FOR USING OTHER FULL AND OPEN  
  COMPETITION:



  	
  14. ACCOUNTING AND APPROPRIATION DATA
  TIN: 
  04-3560100               SOCC
  25.55
  CAN: 
  8-8470038               Amount:  $10,000,000

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

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

  
	
   

  	
   

  	
   

  
	
   

  	
  15A  ITEM NO.

  	
  15B.  SUPPLIES/SERVICES

  	
  15C.  QUANTITY

  	
  15D.  UNIT

  	
  15E.  UNIT PRICE

  	
  15F.  AMOUNT

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:  Biodefense Vaccine
  Enhancement - Development of a Third

  Generation rPA Anthrax Vaccine

  Period:  September 25, 2008 -
  September 24, 2011

  Contract Type: 
  Cost-Plus-Fixed-Fee - Completion

  	
  Year 1

  Year 2

  Year 3

  	
  $4,572,783

  $5,090,714

  $3,544,751

  	
   

  	
   

  
	
   

  	
  15G.  TOTAL
  AMOUNT OF CONTRACT

  	
  

  	
  $13,208,248

  
	
   

  
	
  16.  TABLE OF CONTENTS

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (ü)

  	
  SEC

  	
  DESCRIPTION

  	
  PAGE(S)

  	
  (ü)

  	
  SEC

  	
  DESCRIPTION

  	
  PAGE(S)

  
	
  PART I - THE SCHEDULE

  	
  PART II – CONTRACT CLAUSES

  
	
  x

  	
  A

  	
  SOLICITATION/CONTRACT FORM

  	
  1

  	
  x

  	
  I

  	
  CONTRACT CLAUSES

  	
  48

  
	
  x

  	
  B

  	
  SUPPLIES OR SERVICES AND PRICE/COST

  	
  4

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

  	
   

  
	
  x

  	
  C

  	
  DESCRIPTION/SPECS./WORK STATEMENT

  	
  16

  	
  x

  	
  J

  	
  LIST OF ATTACHMENTS

  	
  58

  
	
  x

  	
  D

  	
  PACKAGING AND MARKING

  	
  23

  	
  PART IV - REPRESENTATIONS AND INSTRUCTIONS

  	
   

  
	
  x

  	
  E

  	
  INSPECTION AND ACCEPTANCE

  	
  23

  	
  x

  	
  K

  	
  REPRESENTATIONS, CERTIFICATIONS AND

  OTHER STATEMENTS OF OFFERORS

  	
  59

  
	
  x

  	
  F

  	
  DELIVERIES OR PERFORMANCE

  	
  24

  
	
  x

  	
  G

  	
  CONTRACT ADMINISTRATION DATA

  	
  32

  	
  o

  	
  L

  	
  INSTRS., CONDS., AND NOTICES TO OFFERORS

  	
   

  
	
  x

  	
  H

  	
  SPECIAL CONTRACT REQUIREMENTS

  	
  36

  	
  o

  	
  M

  	
  EVALUATION FACTORS FOR AWARD

  	
   

  
	
   

  
	
  CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS
  APPLICABLE

  
	
   

  	
   

  
	
  17.  x  CONTRACTOR’S
  NEGOTIATED AGREEMENT (Contractor is

  required to sign this document and return
      2     copies to issuing office)

  Contractor agrees to furnish and deliver all items or perform all the
  services 

  set forth or otherwise identified above and on any continuation sheets for
  the

  consideration stated herein.  The
  rights and obligations of the parties to this

  contract shall be subject to and governed by the following documents:  (a) 

  this award/contract, (b) the solicitation, if any, and (c) such provisions,

  representations, certifications, and specifications, as are attached or

  incorporated by reference herein.  (Attachments are listed herein)

  	
  18.  o  AWARD (Contractor is not required
  to sign this document) Your

  offer on Solicitation Number
                                                                  .

  including the additions or changes made by you which additions or changes are

  set forth in full above, is hereby accepted as to the items listed above and
  on any

  continuation sheets.  This award
  consummates the contract which consists of the

  following documents:  (a) the
  Government’s solicitation and your offer, and (b)

  this award/contract.  No further
  contractual document is necessary.

  
	
   

  	
   

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

  	
  20A. 
  NAME OF CONTRACTING OFFICER

  
	
  Joseph L. O’Connor

  Director of Contracts

  	
  Teresa A. Baughman

  Contracting Officer, OA, DEA, NIAID, NIH, DHHS

  
	
   

  	
   

  	
   

  	
   

  
	
  19B. 
  NAME OF CONTRACTOR

  	
  19C. 
  DATE SIGNED

  	
  20B. 
  UNITED STATES OF AMERICA

  	
  20C. 
  DATE SIGNED

  
	
   

  	
  PharmAthene, Inc.

  	
   

  	
            9/25/08

  	
   

  	
   

  	
   

  	
            9/25/08

  
	
   

  	
  /s/ Joseph L. O’Connor

  	
   

  	
   

  	
  By

  	
  /s/ Theresa A. Baughman

  	
   

  	
   

  
	
   

  	
  (Signature of person authorized to sign)

  	
   

  	
   

  	
   

  	
  (Signature of
  Contracting Office)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NSN  754001-152-8069

  PREVIOUS EDITION UNUSABLE

  	
   

  	
  26-107

  Computer Generated

  	
  STANDARD FORM 26 (REV. 4-85)

  Prescribed by GSA

  FAR (48 CFR) 53 214(a)

  
																																				



 

















 


Contract
Number : HHSN272200800049C


Reference
Number : N01-AI-80049


 


CONTRACT
TABLE OF CONTENTS


 


	
  PART I - THE SCHEDULE

  	
   

  	
  4

  
	
  SECTION A
  - SOLICITATION/CONTRACT FORM

  	
   

  	
  4

  
	
  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

  	
   

  	
  9

  
	
  ARTICLE B.4.
  ADVANCE UNDERSTANDINGS

  	
   

  	
  11

  
	
   

  	
   

  	
   

  
	
  SECTION C
  - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

  	
   

  	
  16

  
	
  ARTICLE C.1.
  STATEMENT OF WORK

  	
   

  	
  16

  
	
  ARTICLE C.2.
  REPORTING REQUIREMENTS

  	
   

  	
  16

  
	
  ARTICLE C.3.
  INVENTION REPORTING REQUIREMENT

  	
   

  	
  22

  
	
   

  	
   

  	
   

  
	
  SECTION D
  - PACKAGING, MARKING AND SHIPPING

  	
   

  	
  23

  
	
  SECTION E -
  INSPECTION AND ACCEPTANCE

  	
   

  	
  23

  
	
   

  	
   

  	
   

  
	
  SECTION F
  - DELIVERIES OR PERFORMANCE

  	
   

  	
  24

  
	
  ARTICLE F.1. PERIOD
  OF PERFORMANCE

  	
   

  	
  24

  
	
  ARTICLE F.2.
  DELIVERIES

  	
   

  	
  24

  
	
  ARTICLE F.3.
  CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

  	
   

  	
  31

  
	
   

  	
   

  	
   

  
	
  SECTION G
  - CONTRACT ADMINISTRATION DATA

  	
   

  	
  32

  
	
  ARTICLE G.1.
  PROJECT OFFICER

  	
   

  	
  32

  
	
  ARTICLE G.2. KEY
  PERSONNEL, HHSAR 352.270-5 (January 2006)

  	
   

  	
  32

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

  	
   

  	
  33

  
	
  ARTICLE G.4.
  INDIRECT COST RATES

  	
   

  	
  34

  
	
  ARTICLE G.5.
  GOVERNMENT PROPERTY

  	
   

  	
  35

  
	
  ARTICLE G.6. POST
  AWARD EVALUATION OF CONTRACTOR PERFORMANCE

  	
   

  	
  35

  
	
   

  	
   

  	
   

  
	
  SECTION H
  - SPECIAL CONTRACT REQUIREMENTS

  	
   

  	
  36

  
	
  ARTICLE H.1. HUMAN SUBJECTS

  	
   

  	
  36

  
	
  ARTICLE H.2. REQUIRED EDUCATION IN THE
  PROTECTION OF HUMAN RESEARCH PARTICIPANTS

  	
   

  	
  36

  
	
  ARTICLE H.3. DATA AND SAFETY
  MONITORING IN CLINICAL TRIALS

  	
   

  	
  36

  
	
  ARTICLE H.4. REGISTRATION OF CLINICAL
  TRIALS IN THE GOVERNMENT DATABASE (ClinicalTrials.gov)

  	
   

  	
  37

  
	
  ARTICLE H.5. HUMAN MATERIALS
  (ASSURANCE OF OHRP COMPLIANCE)

  	
   

  	
  37

  
	
  ARTICLE H.6. RESEARCH INVOLVING
  RECOMBINANT DNA MOLECULES (Including Human Gene Transfer Research)

  	
   

  	
  37

  
	
  ARTICLE H.7. CONTINUED BAN ON FUNDING
  OF HUMAN EMBRYO RESEARCH

  	
   

  	
  38

  
	
  ARTICLE H.8. NEEDLE EXCHANGE

  	
   

  	
  38

  
	
  ARTICLE H.9. PRESS RELEASES

  	
   

  	
  38

  
	
  ARTICLE H.10. DISSEMINATION OF FALSE
  OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION

  	
   

  	
  38

  
	
  ARTICLE H.11. RESTRICTION ON
  EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

  	
   

  	
  38

  
	
  ARTICLE H.12. RESTRICTION ON ABORTIONS

  	
   

  	
  38

  



 


2

















 


	
  ARTICLE H.13. SALARY RATE LIMITATION
  LEGISLATION PROVISIONS

  	
   

  	
  38

  
	
  ARTICLE H.14. PRIVACY ACT, HHSAR
  352.270-11 (January 2006)

  	
   

  	
  39

  
	
  ARTICLE H.15. ANIMAL WELFARE

  	
   

  	
  39

  
	
  ARTICLE H.16. PROTECTION OF PERSONNEL
  WHO WORK WITH NONHUMAN PRIMATES

  	
   

  	
  40

  
	
  ARTICLE H.17. OMB CLEARANCE or
  CLINICAL EXEMPTION

  	
   

  	
  40

  
	
  ARTICLE H.18. OPTION PROVISION

  	
   

  	
  40

  
	
  ARTICLE H.19. INFORMATION SECURITY

  	
   

  	
  40

  
	
  ARTICLE H.20. ELECTRONIC AND
  INFORMATION TECHNOLOGY ACCESSIBILITY (January 2008)

  	
   

  	
  43

  
	
  ARTICLE H.21. INSTITUTIONAL
  RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS

  	
   

  	
  44

  
	
  ARTICLE H.22. PUBLICATION AND
  PUBLICITY

  	
   

  	
  45

  
	
  ARTICLE H.23. REPORTING MATTERS
  INVOLVING FRAUD, WASTE AND ABUSE

  	
   

  	
  45

  
	
  ARTICLE H.24. OBTAINING AND
  DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

  	
   

  	
  45

  
	
  ARTICLE H.25. SHARING RESEARCH DATA

  	
   

  	
  46

  
	
  ARTICLE H.26. POSSESSION USE AND
  TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

  	
   

  	
  46

  
	
  ARTICLE H.27. POSSESSION, USE OR
  TRANSFER OF A HIGHLY PATHOGENIC AGENT

  	
   

  	
  47

  
	
  ARTICLE H.28. HOTEL AND MOTEL FIRE
  SAFETY ACT OF 1990 (P.L. 101-391)

  	
   

  	
  47

  
	
  ARTICLE H.29. PROHIBITION ON
  CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

  	
   

  	
  47

  
	
  ARTICLE H.30. NIH POLICY ON ENHANCING
  PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

  	
   

  	
  47

  
	
   

  	
   

  	
   

  
	
  PART II - CONTRACT
  CLAUSES

  	
   

  	
  48

  
	
  SECTION I
  - CONTRACT CLAUSES

  	
   

  	
  48

  
	
   

  	
   

  	
   

  
	
  PART III - LIST OF
  DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

  	
   

  	
  58

  
	
  SECTION J
  - LIST OF ATTACHMENTS

  	
   

  	
  58

  
	
   

  	
   

  	
   

  
	
  1. Statement of
  Work

  	
   

  	
  58

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

  	
   

  	
  58

  
	
  3. Inclusion
  Enrollment Report

  	
   

  	
  58

  
	
  4. Annual Technical
  Progress Report Format for Each Study

  	
   

  	
  58

  
	
  5. Safety and
  Health

  	
   

  	
  58

  
	
  6. Procurement of
  Certain Equipment

  	
   

  	
  58

  
	
  7. Research Patient
  Care Costs

  	
   

  	
  58

  
	
  8. Disclosure of
  Lobbying Activities, SF-LLL

  	
   

  	
  58

  
	
  9. Commitment To
  Protect Non-Public Information

  	
   

  	
  58

  
	
  10. Roster of
  Employees Requiring Suitability Investigations

  	
   

  	
  58

  
	
  11. Employee
  Separation Checklist

  	
   

  	
  58

  
	
   

  	
   

  	
   

  
	
  PART IV -
  REPRESENTATIONS AND INSTRUCTIONS

  	
   

  	
  59

  
	
  SECTION K
  - REPRESENTATIONS AND CERTIFICATIONS

  	
   

  	
  59

  
	
  1.   Annual Representations and Certifications

  	
   

  	
  59

  
	
  2.   Representations and Certifications

  	
   

  	
  59

  
	
  3.   Human Subjects Assurance Identification Number

  	
   

  	
  59

  
	
  4.   Animal Welfare Assurance Number

  	
   

  	
  59

  



 


3
















 


PART I
- THE SCHEDULE


 


SECTION A -
SOLICITATION/CONTRACT FORM


 


SECTION B - SUPPLIES OR
SERVICES AND PRICES/COSTS


 


ARTICLE B.1.  BRIEF DESCRIPTION OF SUPPLIES OR SERVICES


 


This contract will support the development of
an anthrax vaccine containing rPA and CpG immunostimulant.  The work will demonstrate the following:  stability of the candidate vaccine and
diluent at 35 degrees C over the duration of the base period; safety prior to
human use through acute dose and repeat dose toxicology testing in two (2) animal
species; improved vaccine efficacy over existing vaccines through non-clinical
aerosol challenge studies in the pre-existing rabbit and macaque models, plus
supporting studies in the mouse models; and safety and immunogenicity of the
vaccine in humans through a Phase I dose escalation clinical trial.  The option exists for the scale-up and
validation at 200,000 doses/lot, along with a Phase II clinical trial.


 


ARTICLE B.2.  ESTIMATED COST AND FIXED FEE


 


a.               The estimated
cost of the Base Period of this contract is $ [* * *]


 


b.              The fixed fee
for the Base Period of this contract is $ [* * *] Payment shall be subject to
the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED
FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of
this contract.  Payment of fixed fee
shall not be made in less than monthly increments.


 


c.               The total
estimated amount of the contract, represented by the sum of the estimated cost
plus the fixed fee for the Base Period is $13,208,248.


 


d.              If the
Government exercises its option(s) pursuant to the OPTION PROVISION Article in
SECTION H of this contract, the Government’s total estimated contract
amount represented by the sum of the estimated cost plus the fixed fee will be
increased as follows:


 


	
   

  	
   

  	
  Estimated Cost

  ($)

  	
   

  	
  Fixed Fee

  ($)

  	
   

  	
  Estimated Cost

  Plus Fixed Fee

  ($)

  	
   

  
	
  Base Period - Process
  Devel. & Feasibility

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  $

  	
  13,208,248

  	
   

  
	
  Option 1 - Base Extension - Non-Clinical Development

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  
	
  Option 2 - Base Extension -
  Phase I Clinical Trial

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  
	
  Option 3 - Scale-Up and
  Validation

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  
	
  Option 4 - Phase II Clinical
  Trial

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  
	
  Total Base Period and Options

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  $

  	
  83,891,328

  	
   

  



 


4

















 


e.               Fee Payment
Schedule Based on 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


 


	
  MILESTONE

  	
   

  	
  MILESTONE

  DESCRIPTION

  	
   

  	
  TASK: COMPLETION OF ACTIVITY

  	
   

  	
  ESTIMATED

  COMPLETION

  DATE

  	
   

  	
  FIXED

  FEE ($)

  	
   

  
	
  BASE PERIOD - Process
  Development and Feasibility

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  PROCESS DEVELOPMENT AND
  MANUFACTURING

  	
   

  	
  [* * *]

  	
   

  	
  Mar 2011

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  ASSAYS

  	
   

  	
  [* * *]

  	
   

  	
  Aug 2011

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  STABILITY

  	
   

  	
  [* * *]

  	
   

  	
  July 2011

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4

  	
   

  	
  PRECLINICAL TOXICOLOGY

  	
   

  	
  [* * *]

  	
   

  	
  Mar 2011

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  NON CLINICAL - MODEL
  FEASIBILITY STUDIES (Dstl)

  	
   

  	
  [* * *]

  	
   

  	
  Nov 2010

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10

  	
   

  	
  REGULATORY

  	
   

  	
  [* * *]

  	
   

  	
  May 2011

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11

  	
   

  	
  DELIVERY OF VACCINE TO NIAID

  	
   

  	
  [* * *]

  	
   

  	
  Apr 2011

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  TOTAL BASE PERIOD

  	
   

  	
  [* * *]

  	
   

  



 


5

















 


	
  OPTION 1 - Non-Clinical
  Development

  	
   

  
	
   

  	
   

  
	
  6

  	
   

  	
  NON CLINICAL - RABBIT GUP

  	
   

  	
  [* * *]

  	
   

  	
  To Be Determined (TBD)

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  NON CLINICAL NHP GUP

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8

  	
   

  	
  PASSIVE TRANSFER

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL - OPTION 1

  	
   

  	
  [* * *]

  	
   

  



 


	
  OPTION - Phase I Clinical
  Trial

  	
   

  
	
   

  	
   

  
	
  9

  	
   

  	
  CLINICAL TRIAL (PHASE 1) DOSE ESCALATION

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL - OPTION 2

  	
   

  	
  [* * *]

  	
   

  



 


6

















 


	
  OPTION 3 - Scale-Up and
  Validation

  	
   

  
	
   

  	
   

  
	
  12

  	
   

  	
  DELIVERY OF PROCESS DEVELOPMENT PLAN FOR
  SCALE - UP

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13

  	
   

  	
  FDP DEMONSTRATION AND VERIFICATION

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14

  	
   

  	
  TECHNOLOGY TRANSFER OF DILUENT PROCESS TO CMO

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15

  	
   

  	
  OPTION 1b FDP PROCESS VALIDATION

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16

  	
   

  	
  OPTION 1c CONSISTENCY CAMPAIGN

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  17

  	
   

  	
  OPTION 1b DILUENT CONSISTENCY

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  18

  	
   

  	
  DRUG PRODUCT - ANALYTICAL METHOD VALIDATION
  AT CRO

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  19

  	
   

  	
  DILUENT ASSAYS - TECHNOLOGY TRANSFER AND
  ASSAY VALIDATION

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  20

  	
   

  	
  IMMUNOPOTENCY ASSAY DEVELOPMENT

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  



 


7

















 


	
  OPTION 3 - Scale-Up and
  Validation

  	
   

  
	
   

  	
   

  
	
  21

  	
   

  	
  STABILITY OF FDP

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  22

  	
   

  	
  STABILITY OF DILUENT

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL OPTION 3

  	
   

  	
  [* * *]

  	
   

  



 


	
  OPTION 4 - Phase II Clinical
  Trial

  	
   

  
	
   

  	
   

  
	
  23

  	
   

  	
  cGMP MANUFACTURE OF FDP CLINICAL BATCHES

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  24

  	
   

  	
  STABILITY OF CLINICAL LOTS

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  25

  	
   

  	
  PHASE II CLINICAL TRIAL

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  26

  	
   

  	
  RABBIT PASSIVE TRANSFER USING HUMAN PHASE
  I & PHASE II SERA

  	
   

  	
  [* * *]

  	
   

  	
  TBD

  	
   

  	
  [* * *]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL OPTION 4

  	
   

  	
  [* * *]

  	
   

  



 


8

















 


f.                 Total funds
currently available for payment and allotted to this contract are $10,000,000
of which [* * *] represents the estimated costs, and of which [* * *]
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.


 


g.              It is estimated
that the amount currently allotted will cover performance of the contract
through September 24, 2010.


 


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


 


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; see subparagraph b. below


 


5.               Foreign travel
- See subparagraph b. below;


 


6.               Consultant
costs;


 


7.               Subcontracts;


 


8.               Patient care
costs;


 


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


 


9

















 


10.         Light
Refreshment and Meal Expenditures


 


Requests to use contract funds to provide light
refreshments and/or meals to either federal or nonfederal employees must be
submitted to the Project Officer, with a copy to the Contracting Officer, at
least six (6) weeks in advance of the event.  The request shall contain the following
information:  (a) name, date, and
location of the event at which the light refreshments and/or meals will be
provided; (b) a brief description of the purpose of the event; (c) a
cost breakdown of the estimated light refreshment and/or meal costs; (d) the
number of nonfederal and federal attendees receiving light refreshments and/or
meals; and (e) if the event will be held somewhere other than a government
facility, provide an explanation of why the event is not being held at a
government facility.


 


Refer to NIH Manual Chapter 1160-1,
Entertainment, for more information on NIH’s policy on the use of appropriated
funds for light refreshments and meals.


 


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 the following amounts for
the base period and any option (if exercised)
without the prior written approval of the Contracting Officer:


 


·                  Base
Period:  [ * * *]


 


·                  Option 1:  [* * *]


 


·                  Option 2:  [* * *]


 


·                  Option 3:  [* * *]


 


·                  Option 4:  [* * *]


 


b.              The Contractor shall invoice and be reimbursed
for all travel costs in accordance with Federal Acquisition Regulations (FAR)
31.2 - Contracts with Commercial Organizations, Subsection 31.205-46, Travel
Costs.


 


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.


 


10

















 


ARTICLE B.4.  ADVANCE UNDERSTANDINGS


 


Other provisions of this contract
notwithstanding, approval of the following items, for the base period and any option (if exercised), within the limits set forth is hereby granted
without further authorization from the Contracting Officer.


 


a.               Subcontracts


 


[* * *]


 


To negotiate a subcontract with [* * *] for [*
* *] an amount not to exceed as follows:


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[*
* *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[*
* *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[*
* *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


11
















 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


12

















 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not
proceed without the prior written consent of the Contracting Officer upon
review of the supporting documentation required by FAR Clause 52.244-2,
Subcontracts.  After receiving written
consent of the subcontract by the Contracting Officer, a copy of the signed,
executed subcontract shall be provided to the Contracting Officer.


 


[* * *]


 


To negotiate a subcontract with [* * *]
for [* * *] for an amount not to exceed as follows:


 


·                  [* * *]


 


·                  [* * *]


 


Award of the subcontract shall not proceed
without the prior written consent of the Contracting Officer upon review of the
supporting documentation required by FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the
subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.


 


b.              Consultants [* * *]


 


13

















 


[* * *]


 


c.               Confidential Treatment of Sensitive Information


 


The Government has determined that the
information that the Contractor will generate, have access to, or be furnished
by the Government during the performance of the contract is of a sensitive
nature.  The Contractor shall guarantee
strict confidentiality of this information.


 


Disclosure of the information, 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 under the contract, the Contractor shall obtain a written
determination from the Contracting Officer.


 


14

















 


d.              Contract Number Designation


 


On all correspondence submitted under this
contract, the Contractor agrees to clearly identify the two contract numbers
that appear on the face page of the contract as follows:


 


Contract No. HHSN272200800049C


 


NIAID Reference No. N01-AI-80049


 


e.               Advance Copies of Press Releases


 


The Contractor agrees to accurately and
factually represent the work conducted under this contract in all press
releases.  In accordance with NIH Manual
Chapter 1754, misrepresenting contract results or releasing information that is
injurious to the integrity of NIH may be construed as improper conduct.  The complete text of NIH Manual Chapter 1754
can be found at:  http://www1.od.nih.gov/oma/manualchapters/management/1754/


 


Press releases shall be considered to include
the public release of information to any medium, excluding peer-reviewed
scientific publications.  The Contractor
shall ensure that the Project Officer has received an advance copy of any press
release related to this contract not less than seven (7) calendar days
prior to the issuance of the press release.


 


f.                 Indirect Costs


 


[* * *]


 


15

















 


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, dated September 25, 2008, set forth in SECTION J-List of
Attachments, attached hereto and made a part of this contract.


 


b.              Privacy Act
System of Records Number 09-25-0200 is applicable to this contract and shall be
used in any design, development, or operation work to be performed under the
resultant contract.  Disposition of
records shall be in accordance with SECTION C of the contract, and by
direction of the Project Officer(s).


 


ARTICLE C.2.  REPORTING REQUIREMENTS


 


All reports required herein shall be submitted
in electronic format.  In addition, one (1) hardcopy
of each report shall be submitted to the Project Officer and the Contracting
Officer, unless otherwise specified.  The reports included in this Article are
applicable to the base period and any option (if exercised).


 


a.               Technical Reports


 


In addition to those reports required by the
other terms of this contract, the Contractor shall prepare and submit the
following reports during the period of performance of this contract:


 


[Note:  Beginning May 25, 2008, the Contractor
shall include, in any technical progress report submitted, the applicable
PubMed Central (PMC) or NIH Manuscript Submission reference number when citing
publications that arise from its NIH funded research.]


 


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


 


Format of Cover Page:  All reports shall include a cover page prepared
in accordance with the following format:


 


·                  Contract Number
and Project Title


 


·                  Title of Report


 


·                  Period of
Performance Being Reported


 


·                  Contractor’s
Name and Address


 


·                  Author(s)


 


·                  Date of
Submission


 


·                  Delivery
Address


 


16

















 


1.               Monthly Progress Report


 


The Monthly Progress Report shall include a
description of the activities during the reporting period, and the activities
planned for the ensuing reporting period. 
The first reporting period consists of the first full month of
performance plus any fractional part of the initial month.  Thereafter, the reporting period shall
consist of each calendar month.  A Monthly
Progress Report shall not be required when an Annual Progress Report or the
Final Report is due.


 


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


 


Section B - The Monthly
Progress Report shall describe the results of work performed during the
reporting period for each milestone and key objective in the approved Product
Development Plan.  For each milestone,
include a summary of accomplishments in sufficient detail to explain comprehensively
the results achieved, and a summary of any technical issues/problems
encountered during the reporting period. 
The description shall include pertinent data and/or graphs in sufficient
detail to explain any significant results achieved, preliminary conclusions
resulting from analysis, and scientific evaluation of data accumulated to date
under the project for each milestone. 
The current status of each milestone and sub-task shall be displayed on
an updated Gantt chart as a component of the Monthly Progress Report.  In addition, requests and approvals to
conduct human trials, and Inclusion Enrollment Report forms, when appropriate,
shall be included.  Preprints and
reprints of papers, abstracts, and slides used in oral presentations shall also
be submitted with the Monthly Progress Report.


 


Section C - Substantive performance:  Describe current technical or substantive
performance, any problems encountered, and corrective actions taken or
proposed.  Explain any differences
between planned progress and actual progress, reasons for differences that have
occurred, and corrective actions taken or proposed.  Provide a summary of work proposed for the
next year period.  Submit copies of
manuscripts (published and unpublished), abstracts, and any protocols or
methods developed specifically under the contract during the reporting
period.  Include a summary of any
inventions developed during the course of the contract.  If applicable, advise the NIAID of other
government-funded activities beyond the Contractor’s control that could
adversely impact performance.


 


Section D - Estimated
and actual total costs incurred shall be provided for each milestone and task
performed during the reporting period. 
Costs shall be reported by a breakdown of Direct Labor, Direct
Materials, Subcontracts, Consultants, Travel, etc.


 


2.               Annual Progress Report


 


The Annual Progress Report shall include a
summation of the results of the entire contract work for the period
covered.  The Annual Progress Report is
due after each anniversary date of the contract.  An Annual Progress Report will not be
required for the period when the Final Report is due.


 


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


 


Section B - Describe the
results of work accomplished during the reporting period in relation to the
approved Product Development Plan and each key objective and milestone.  For each milestone, include a summary of
accomplishments in sufficient detail to explain comprehensively the results
achieved, and a summary of technical issues/problems encountered for the
reporting period.  The description shall
include pertinent data and/or graphs in sufficient detail to explain any
significant results achieved, preliminary conclusions resulting from analysis,
and scientific evaluation of data accumulated to date under the project for
each milestone.  The current status of
each milestone and sub-task shall be displayed on an updated Gantt chart as a
component of the Annual Progress Report. 
In addition, requests and approvals to conduct human trials, and Inclusion
Enrollment Report forms, when appropriate, shall be included.


 


17

















 


Section C - Substantive performance:  Describe current technical or substantive
performance, any problems encountered, and corrective actions taken or
proposed.  Explain any differences
between planned progress and actual progress, reasons for differences that have
occurred, and corrective actions taken or proposed.  Provide a summary of work proposed for the
next year period.  Submit copies of
manuscripts (published and unpublished), abstracts, and any protocols or
methods developed specifically under the contract during the reporting
period.  Include a summary of any
inventions developed during the course of the contract.


 


Section D - Estimated
and actual total costs incurred shall be provided for each milestone and task
performed during the reporting period. 
Costs shall be reported by a breakdown of Direct Labor, Direct
Materials, Subcontracts, Consultants, Travel, etc.


 


3.               Annual Technical Progress Report for Clinical Research Study Populations


 


The Contractor shall submit information about
the inclusion of women and members of minority groups and their subpopulations
for each study being performed under this contract.  The Contractor shall submit this information
in the format indicated in the Attachment entitled, “Inclusion Enrollment
Report,” which is set forth in SECTION J of this contract.  The Contractor also shall use this format,
modified to indicate that it is a final report, for reporting purposes in the
final report.  The Contractor shall
submit the report in accordance with the DELIVERIES Article in SECTION F
of this contract.


 


In addition, the NIH Policy and Guidelines on
the Inclusion of Women and Minorities as Subjects in Clinical Research,
Amended, October, 2001 applies.  If this
contract is for Phase III clinical trials, see Il.B of these guidelines.  The Guidelines may be found at the following
website:


 


http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm


 


Include a description of the plans to conduct
analyses, as appropriate, by sex/gender and/or racial/ ethnic groups in the
clinical trial protocol as approved by the IRB, and provide a description of
the progress in the conduct of these analyses, as appropriate, in the annual
progress report and the final report.  If
the analysis reveals no subset differences, a brief statement to that effect,
indicating the subsets analyzed, will suffice. 
The Government strongly encourages inclusion of the results of subset
analysis in all publication submissions. 
In the final report, the Contractor shall include all final analyses of
the data on sex/gender and race/ethnicity.


 


4.               Draft Final Report


 


The Contractor shall provide the Project
Officer with a copy of the Final Report in draft form ninety (90) calendar days
prior to the completion date of the contract. 
The Final Report shall contain an executive summary for activities
performed under the contract.  The format
described for the Monthly Progress Report shall be used for the Final
Report.  The Project Officer will review
the Draft Final Report and provide the Contractor with comments within fifteen
(15) calendar days after receipt.  The
Final Report shall be corrected by the Contractor, if necessary.


 


5.               Final Report


 


The Final Report shall include a summation of
the work performed and results obtained for the entire contract period of
performance.  This report shall be in
sufficient detail to describe comprehensively the methods used and the results
achieved, shall use the format for the Monthly Progress Report, and shall also
contain an executive summary for activities performed under the contract.  Preprints and reprints not submitted
previously shall be submitted as an appendix. 
The Final Report shall be submitted in accordance with the DELIVERIES Article in
SECTION F of the contract.


 


18

















 


6.               Summary of Salient Results


 


The Contractor shall submit, with the Final
Report, a summary (not to exceed 200 words) of salient results achieved during
the performance of the contract.


 


7.               Report on Select Agents or Toxins and/or Highly Pathogenic Agents


 


For work involving the possession, use, or
transfer of a Select Agent or Toxin
and/or a Highly Pathogenic Agent,
the following information shall also be included in each Annual Progress
Report:


 


1.               Any changes in the use of the Select Agent or Toxin and/or a Highly Pathogenic Agent, that have
resulted in a change in the required biocontainment level, and any resultant change
in location, if applicable, as determined by the IBC or equivalent body or
institutional biosafety official.


 


2.               If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted
in the upcoming reporting period, provide:


 


a.               A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be
studied;


 


b.              A description of the work that will be done
with each new or additional Select Agent or
Toxin and/or a Highly Pathogenic
Agent;


 


c.               The title and location for each biocontainment
resource/facility, including the name of the organization that operates the
facility, and the biocontainment level at which the work will be conducted,
with documentation of approval by your IBC or equivalent body or institutional
biosafety official.  It must be noted if
the work is being done in a new location.


 


If the IBC or equivalent body or institutional
biosafety official has determined, for example, by conducting a risk
assessment, that the work that has been performed or is planned to be performed
under this contract may be conducted at a biocontainment safety level that is
lower than BSL3, a statement to that affect shall be included in each Annual
Progress Report.


 


If no work involving a Select Agent or Toxin
and/or a Highly Pathogenic Agent has been performed or is planned to be
performed under this contract, a statement to that affect shall be included in
each Annual Progress Report.


 


b.              Other Reports/Deliverables


 


In addition to the above reports, the following
are considered other reports and deliverables under this contract and are
identified in the Statement of Work.  A
listing is included in the DELIVERIES Article in SECTION F.


 


1.               Product Development Plan


 


Within thirty (30) calendar days after the
effective date of the contract and prior to initiation of product development
activities, the Contractor shall submit to the Project Officer and Contracting
Officer an updated Product Development Plan to accomplish the product
development activities detailed in the negotiated Statement of Work for the
base period of performance, plus Options 1 and 2 (if exercised).  This Plan shall be updated following any
milestone change or deviation.


 


Within sixty (60) calendar days after the
exercise of Option 3, the Contractor shall submit to the Project Officer and
Contracting Officer an updated Option 3 Product Development Plan to accomplish
the product development activities detailed in the negotiated Statement of Work
for Option 3.  This Plan shall be updated
following any milestone change or deviation during this Option.


 


19

















 


Within sixty (60) calendar days after the
exercise of Option 4, the Contractor shall submit to the Project Officer and
Contracting Officer an updated Option 4 Product Development Plan to accomplish
the product development activities detailed in the negotiated Statement of Work
for Option 4.  This Plan shall be updated
following any milestone change or deviation during this Option.


 


The Product Development Plan shall include:


 


a) clearly defined goals for each proposed
stage of product development where “Go/No Go” decision points have been
identified;


 


b) quantitative and qualitative criteria for
assessing the scientific merit and feasibility of moving to the next stage of
product development;


 


c) a detailed Gantt chart with a timeline with
subtask, predecessor and successor logic for each milestone covering the
initiation, conduct and completion of product development tasks; and


 


d) a task linked budget listing a breakdown of
total costs linked to each milestone, task and subtask.


 


2.               Implementation Plan


 


Within thirty (30) calendar days after the
effective date of the contract and prior to initiation of product development
activities the Contractor shall submit to the Project Officer and Contracting
Officer an updated Implementation Plan to accomplish the product development
activities detailed in the negotiated Statement of Work for the base period of
performance, plus Options 1 and 2 (if exercised).  This Plan shall be updated following any
milestone change or deviation.


 


Within sixty (60) calendar days after the
exercise of Option 3, the Contractor shall submit to the Project Officer and
Contracting Officer an Option 3 updated Implementation Plan to accomplish the
product development activities detailed in the negotiated Statement of Work for
Option 3.  This Plan shall be updated
following any milestone change or deviation during this Option.


 


Within sixty (60) calendar days after the
exercise of Option 4, the Contractor shall submit to the Project Officer and
Contracting Officer an Option 4 updated Implementation Plan to accomplish the
product development activities detailed in the negotiated Statement of Work for
Option 4.  This Plan shall be updated
following any milestone change or deviation during this Option.


 


The Implementation Plan shall contain a
detailed discussion of the proposed technical approach for each activity to be
performed to achieve project objectives in sufficient detail to explain and
justify fully the scientific/technical rationale for the proposed approaches
and/or methodologies and reflecting a clear understanding of the scope and
nature of the work to be carried out.


 


3.               Product Development Reports


 


The Contractor shall provide all Product
Development Reports that document compliance with the requirements of cGMP and
product characterization and release testing in compliance with GLP, including
Shipping Validation Reports and Chemistry, Manufacturing and Controls (CMC) information,
and all raw data and statistical analyses to the Project Officer and the NIAID
Regulatory Affairs designee.


 


4.               Non-Clinical Study Protocols and Reports


 


The Contractor shall provide to the Project
Officer and to the NIAID Regulatory Affairs designee Draft and Final
Non-Clinical Study Protocols and Reports, including associated Standard
Operating Procedures (SOPs) and procedures necessary to support the development
and submission of IND applications to the FDA.


 


20

















 


5.               Contract Initiation Meeting, Annual Contract Review Meetings, and
Additional Contract Meetings Reports


 


Reports of the Contract Initiation Meeting, the
Annual Contract Review Meetings, and the Additional Contract Meetings shall be
prepared and submitted by the Contractor to the Project Officer and Contracting
Officer within twenty-one (21) calendar days following each meeting.  These reports shall include a list of
attendees, summaries of discussions, and copies of all meeting materials.


 


6.               Publications and Presentation Materials


 


The Contractor shall provide manuscripts,
scientific meeting abstracts, and oral presentations containing data generated
under this contract to the Project Officer for review prior to submission for
publication or public presentation.


 


a) Manuscripts shall be submitted no less than
thirty (30) calendar days in advance of submission.


 


b) Abstracts and oral presentations shall be
submitted no less than ten (10) calendar days in advance of presentation.


 


7.               Serious Adverse Events Reports


 


The Contractor shall submit Serious Adverse
Events (SAE) Reports to the Project Officer and to the NIAID Regulatory Affairs
designee according to the NIAID Clinical Terms of Award (http://www.niaidnih.gov/ncn/pdf/clinterm.pdf).


 


8.               Clinical Trial Monitoring Plan and Clinical Trial Protocols


 


The NIAID has a responsibility to ensure that
mechanisms and procedures are in place to protect the safety of participants in
NIAID-funded clinical trials.  Therefore,
as described in the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf),
the Contractor shall develop a protocol for each clinical trial and submit all
protocols and protocol amendments for approval by the Project Officer.  Protocols must be submitted using the
approved DMID template and include a sample Informed Consent and Clinical
Trials Monitoring Plan.  The DMID
templates and other important information regarding performing human subjects
research are available at http://www3.niaid.nih.gov/research/resources/DMIDCIinRsrch//.


 


9.               FDA Correspondence and Meeting Summaries


 


The Project Officer and Project Officer’s
designees shall be granted permission by the Contractor to be an observer at
all FDA meetings and teleconferences related to any activities being performed
as part of this contract, including work performed by subcontractors and
collaborators.  The Contractor shall
provide copies of all correspondence relating to this contract sent to and
received from the FDA and shall provide minutes of meetings held with the FDA
within five (5) calendar days after the meeting date to the Project Officer and
the NIAID Regulatory Affairs designee.


 


10.         Final Clinical Study Report


 


The Final Clinical Study Report shall follow
the ICH guidelines on Structure and Content of Clinical Study Reports E3 (http://www.pharmacontract.ch/support/su_ich_Iiste.htm).  Final Clinical Study Reports shall be
provided within thirty (30) calendar days after the completion of the analysis
of all clinical trial data to the Project Officer and the NIAID Regulatory
Affairs designee.


 


21
















 


ARTICLE C.3.  INVENTION REPORTING REQUIREMENT


 


All reports and documentation required by FAR
Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not
limited to, the invention disclosure report, the confirmatory license, and the
Government support certification, shall be directed to:


 


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(b)(2)(ii))
shall be submitted to the Contracting Officer on the completion date of the
contract.


 


The annual utilization report shall be
submitted in accordance with the DELIVERIES Article in SECTION F of
this contract. The first annual utilization report shall be due on or before
due on or before the 30th of the month following each anniversary date of the
contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be
submitted on the completion date of the contract. All reports shall be sent to
the following address:


 


Contracting Officer

MID Research Contract Branch-B

Office of Acquisitions, DEA, NIAID, NIH

6700-B Rockledge Drive, Room 3214, MSC 7612 

Bethesda, MD 20892-7612


 


Direct Phone
Number:  301-451-3690 

Office Phone Number:  301-496-0612

Fax Number:  301-402-0972


 


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.


 


22

















 


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 identified in ARTICLE G.1. is the
authorized representative of the Contracting Officer.


 


c.              Inspection and
acceptance will be performed at:


 


National Institutes of
Health

National Institute of Allergy and Infectious Diseases

Division of Microbiology and Infectious Diseases

6610 Rockledge Drive

Bethesda, MD 20892


 


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


 


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


 


FAR Clause 52.246-8, Inspection of Research and Development -
Cost-Reimbursement (May 2001).


 


23

















 


SECTION F 
DELIVERIES OR PERFORMANCE


 


ARTICLE F.1.  PERIOD
OF PERFORMANCE


 


a.              The period of
performance of this contract shall be from September 25, 2008 through September 24,
2011.


 


b.             If the
Government exercises its option(s) pursuant to the OPTION PROVISION Article in
Section H of this contract, the period of performance will be increased as
listed below:


 


	
  Option

  	
   

  	
  Option Period

  
	
  1 - Base Extension - Non- Clinical Development

  	
   

  	
  Two (2) years beginning with the
  effective date of the exercise of Option 1.

  
	
  2 - Base Extension - Phase I Clinical
  Trial

  	
   

  	
  Two (2) years beginning with the
  effective date of the exercise of Option 2.

  
	
  3 - Scale-Up and Validation

  	
   

  	
  Five (5) years beginning with the
  effective date of the exercise of Option 3.

  
	
  4 - Phase II Clinical Trial

  	
   

  	
  Three (3) years beginning with the
  effective date of the exercise of Option 3.

  



 


ARTICLE F.2.  DELIVERIES


 


Satisfactory performance of the final contract
shall be deemed to occur upon performance of the work described in the
Statement of Work Article in SECTION C of this contract 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:


 


The items specified below as described in the
REPORTING REQUIREMENTS Article in SECTION C of this contract 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 and any specifications stated in SECTION D,
PACKAGING, MARKING AND SHIPPING, of this contract:


 


a.               Reports and Deliverables


 


	
  Item

  	
   

  	
  Report/Deliverable

  	
   

  	
  Delivery Schedule

  
	
  1.

  	
   

  	
  Monthly Progress Report

  	
   

  	
  The first report is due on or before
  November 15, 2008. Thereafter, each report is due on or before the 15th
  of the month following each reporting period. Monthly Progress Reports are
  not required when an Annual Progress Report or Final Report is due.

  
	
  2.

  	
   

  	
  Annual Progress Report

  	
   

  	
  The first report is due on or before
  October 30, 2009. Thereafter, each report is due on/before the 30th of
  the month following each anniversary date of the contract. An Annual Progress
  Report is not due when a Final Report is due.

  
	
  3.

  	
   

  	
  Annual Technical Progress Report for
  Clinical Research Study Populations (Options 2 and 4)

  	
   

  	
  The first report is due the 30th of the
  month following the date 

  Option 2 is exercised. Thereafter, each report is due on or before the 30th
  of the month following each anniversary date in 

  Options 2 and 4.

  
	
  4.

  	
   

  	
  Draft Final Report

  	
   

  	
  Due 90 calendar days prior to the
  completion date of the contract.

  
	
  5.

  	
   

  	
  Final Report and Summary of Salient
  Results

  	
   

  	
  Due on or before the completion date of
  the contract

  
	
  6.

  	
   

  	
  Contract Initiation Meeting, Annual
  Contract Review Meetings, and Additional Contract Meetings Reports

  	
   

  	
  Due within 21 calendar days following
  each meeting.

  



 


24

















 


	
  Item

  	
   

  	
  Report/Deliverable

  	
   

  	
  Delivery Schedule

  
	
  7.

  	
   

  	
  Publications and Presentation Materials

  	
   

  	
  Manuscripts are due 30 calendar days in
  advance of submission.

   

  Abstracts and oral presentations are
  due 10 calendar days in advance of presentation.

  
	
  8.

  	
   

  	
  Product Development Plans

  	
   

  	
  Initial Updated Plan is due
  October 25, 2008 and following any milestone change or deviation.

   

  Option 3 Updated Plan is due 60
  calendar days after the exercise of Option 3 and following any milestone
  change or deviation.

   

  Option 4 Updated Plan is due 60
  calendar days after the exercise of Option 4 and following any milestone
  change or deviation.

  
	
  9.

  	
   

  	
  Implementation Plans

  	
   

  	
  Initial Updated Plan is due
  October 25, 2008 and following any milestone change or deviation.

   

  Option 3 Updated Plan is due 60
  calendar days after the exercise of Option 3 and following any milestone
  change or deviation.

   

  Option 4 Updated Plan is due 60
  calendar days after the exercise of Option 4 and following any milestone
  change or deviation.

  
	
  10.

  	
   

  	
  Product Development Reports including:

   

  Shipping Validation Reports;

   

  Chemistry, Manufacturing and Controls
  (CMC) Information;

   

  All raw data and statistical analyses

  	
   

  	
  To be negotiated.

  
	
  11.

  	
   

  	
  Draft Non-Clinical Study Protocols and
  Reports

  	
   

  	
  To be negotiated.

  
	
  12.

  	
   

  	
  Final Non-Clinical Study Protocols and
  Reports

  	
   

  	
  To be negotiated.

  
	
  13.

  	
   

  	
  Standard Operating Procedures (SOPs)

  	
   

  	
  To be negotiated.

  
	
  14.

  	
   

  	
  Serious Adverse Events (SAE) Reports

   

  (Options
  2 and 4 only)

  	
   

  	
  In accordance with NIAID Clinical Terms
  of Award.

  
	
  15.

  	
   

  	
  Sample Informed Consent and Clinical
  Trial Monitoring Plan (Options 2 and 4 only)

  	
   

  	
  In accordance with NIAID Clinical Terms
  of Award.

  
	
  16.

  	
   

  	
  Final Clinical Study Report

   

  (Options
  2 and 4 only)

  	
   

  	
  Due 30 calendar days after the
  completion of the analysis of all clinical trial data.

  
	
  17.

  	
   

  	
  Food and Drug Administration (FDA)
  Correspondence and Meeting Summaries

  	
   

  	
  Due five (5) calendar days after
  the meeting is held or correspondence is sent.

  
	
  18.

  	
   

  	
  Process Development Final Report (SOW,
  Base Period, Milestone 1.a.)

  	
   

  	
  Prior to technical transfer and scale
  up of process.

  
	
  19.

  	
   

  	
  Technical Transfer Audit Report and
  Quality Agreement Statement of Work (SOW, Base

  Period. Milestone 1.b.)

  	
   

  	
  Prior to placing orders with CMO.

  
	
  20.

  	
   

  	
  Technical Transfer Completion Reports,
  including Analytical Qualification Reports (SOW, Base Period, Milestone 1.b.)

  	
   

  	
  Prior to GMP manufacture.

  



 


25

















 


	
  Item

  	
   

  	
  Report/Deliverable

  	
   

  	
  Delivery Schedule

  
	
  21.

  	
   

  	
  Master Batch Records (MBRs) (SOW, Base
  Period, Milestone 1.c.)

  	
   

  	
  Prior to production of the
  demonstration batches.

  
	
  22.

  	
   

  	
  Executed Batch Manufacturing Records
  (BMRs) and Certificate of Analysis (SOW, Base Period, Milestone 1.f.)

  	
   

  	
  Within five (5) months after
  manufacture.

  
	
  23.

  	
   

  	
  Qualification of Process Assays Reports
  (SOW, Base Period, Milestone 2.a.)

  	
   

  	
  Within 14 months after the effective
  date of the contract.

  
	
  24.

  	
   

  	
  Qualification of Product Assays Reports
  (SOW, Base Period, Milestone 2.b.)

  	
   

  	
  Within 14 months after the effective
  date of the contract.

  
	
  25.

  	
   

  	
  Qualification of Stability Indicating
  Assays Reports (SOW, Base Period, Milestone
  2.c.)

  	
   

  	
  Within 14 months after the effective
  date of the contract.

  
	
  26.

  	
   

  	
  Qualification of Immuno-Potency Assay
  Reports (SOW, Base Period, Milestone 2.d.)

  	
   

  	
  Within 24 months after the effective
  date of the contract.

  
	
  27.

  	
   

  	
  Stability Trials Audit Report and
  Quality Agreement (SOW, Base Period, Milestone
  3.0.)

  	
   

  	
  Prior to placing orders with the
  Clinical Research Organization (CRO)

  
	
  28.

  	
   

  	
  cGMP Stability Protocols (SOW, Base
  Period, Milestone 3.0.)

  	
   

  	
  One (1) month prior to the
  initiation of the stability study.

  
	
  29.

  	
   

  	
  Stability Study Report (SOW, Base
  Period, Milestone 3.0.)

  	
   

  	
  Within 30 calendar days after
  completion of the study.

  
	
  30.

  	
   

  	
  Draft Safety and Toxicity
  Protocol(s) (SOW, Base Period, Milestone
  4.a.)

  	
   

  	
  To be negotiated.

  
	
  31.

  	
   

  	
  CRO Audit Report and Quality Agreement
  (SOW, Base Period, Milestone 4.a.)

  	
   

  	
  To be negotiated.

  
	
  32.

  	
   

  	
  Acute Dose Safety and Toxicity Studies
  Reports (SOW, Base Period, Milestone 4.b.)

  	
   

  	
  To be negotiated.

  
	
  33.

  	
   

  	
  Repeat Dose Safety and Toxicity Studies
  Reports (SOW, Base Period, Milestone 4.c.)

  	
   

  	
  To be negotiated.

  
	
  34.

  	
   

  	
  Safety Pharmacology Study (SOW, Base
  Period, Milestone 4.d.)

  	
   

  	
  To be negotiated.

  
	
  35.

  	
   

  	
  Final Documentation of FDA Concurrence
  (SOW, Base Period, Milestone 4.e.)

  	
   

  	
  To be negotiated.

  
	
  36.

  	
   

  	
  A Draft Protocol, Animal Studies Group
  (ASG) Minutes and Concurrence for the each of the following mouse model
  studies (SOW, Base Period, Milestone 5.a.)
  :

   

  Excipient Effects;

   

  Immunogencity;

   

  Dose Ranging; and,

   

  Adjuvant Requirements.

  	
   

  	
  To be negotiated.

  
	
  37.

  	
   

  	
  Final Reports for the each of the
  following mouse model studies (SOW, Base Period, Milestone 5.b.) :

   

  Excipient Effects;

   

  Immunogencity;

   

  Dose Ranging:  and,

   

  Adjuvant Requirements

  	
   

  	
  To be negotiated.

  



 


26

















 


	
  Item

  	
   

  	
  Report/Deliverable

  	
   

  	
  Delivery Schedule

  
	
  38.

  	
   

  	
  Non Clinical Study Rabbit Model Audit
  Report and Quality Agreement (SOW, Option 1 , Milestone 6.a.)

  	
   

  	
  Prior to placing orders with the CRO.

  
	
  39.

  	
   

  	
  Non Clinical Study Rabbit Model
  Protocol (SOW, Option
  1, Milestone 6.a.)

  	
   

  	
  To be negotiated.

  
	
  40.

  	
   

  	
  Rabbit Model Immune Response Interim
  Report (SOW, Option 1,
  Milestone 6.c.)

  	
   

  	
  To be negotiated.

  
	
  41.

  	
   

  	
  Rabbit Model Immune Response Final
  Report (SOW, Option 1,
  Milestone 6.c.)

  	
   

  	
  To be negotiated.

  
	
  42.

  	
   

  	
  Animal Dose Ranging Challenge Study
  Interim Report (SOW, Option
  1, Milestone 6.e.)

  	
   

  	
  To be negotiated.

  
	
  43.

  	
   

  	
  Animal Dose Ranging Challenge Study
  Interim Report (SOW, Option
  1, Milestone 6.e.)

  	
   

  	
  To be negotiated.

  
	
  44.

  	
   

  	
  Non Clinical Study Non-Human Primate
  Model Audit Report and Quality Agreement (SOW, Option 1, Milestone 7.a.)

  	
   

  	
  Prior to placing orders with the CRO.

  
	
  45.

  	
   

  	
  Non Clinical Study Non-Human Primate
  Model Protocol (SOW, Option
  1, Milestone 7.a.)

  	
   

  	
  To be negotiated.

  
	
  46.

  	
   

  	
  Non-Human Primate Model Dose Ranging
  Challenge Study Interim Report (SOW, Option 1, Milestone
  7.c.)

  	
   

  	
  To be negotiated.

  
	
  47.

  	
   

  	
  Non-Human Primate Model Dose Ranging
  Challenge Study Final Report (SOW, Option 1, Milestone
  7.c.)

  	
   

  	
  To be negotiated.

  
	
  48.

  	
   

  	
  Passive Transfer Audit Report and
  Quality Agreement (SOW, Option
  1, Milestone 8.a.)

  	
   

  	
  Prior to placing orders with the CRO.

  
	
  49.

  	
   

  	
  Passive Transfer Protocol (SOW, Option 1, Milestone 8.a.)

  	
   

  	
  To be negotiated.

  
	
  50.

  	
   

  	
  Passive Transfer Final Report (SOW, Option 1, Milestone 8.c.)

  	
   

  	
  To be negotiated.

  
	
  51.

  	
   

  	
  Phase I Clinical Trial Audit Report and
  Quality Agreement (SOW, Option
  2, Milestone 9.a.)

  	
   

  	
  Prior to placing orders with the CRO.

  
	
  52.

  	
   

  	
  Phase I Clinical Trial Documentation
  (including Protocol and Investigators Brochure) (SOW, Option 2, Milestone 9.b.)

  	
   

  	
  To be negotiated.

  
	
  53.

  	
   

  	
  Documentation of Interactions with CBER
  and CBER Concurrence (SOW, Option 2, Milestone
  9.c.)

  	
   

  	
  To be negotiated.

  
	
  54.

  	
   

  	
  Phase I Clinical Trial Report (SOW, Option 2, Milestone 9.e.)

  	
   

  	
  To be negotiated.

  
	
  55.

  	
   

  	
  2,000 Clinical Doses of cGMP Vaccine
  and Associated Certificate of Analysis (SOW, Option 2, Milestone 11.a.)

  	
   

  	
  To be negotiated.

  
	
  56.

  	
   

  	
  2,000 Doses of cGMP Diluent and
  Associated Certificate of Analysis (SOW, Option 2, Milestone
  11.a.)

  	
   

  	
  To be negotiated.

  
	
  57.

  	
   

  	
  Final Approved Master Batch Records
  (MBRs) for Process Scale-Up of Final Drug Product (FDP)(SOW, Option 3, Milestone 13)

  	
   

  	
  Prior to cGMP manufacture.

  
	
  58.

  	
   

  	
  Final Report of Process Scale-Up for
  FDP (SOW Option 3,
  Milestone 13)

  	
   

  	
  To be negotiated.

  



 


27

















 


	
  Item

  	
   

  	
  Report/Deliverable

  	
   

  	
  Delivery Schedule

  
	
  59.

  	
   

  	
  Executed Batch Manufacturing Records
  (BMRs) and Certificate of Analysis for Process Scale-Up of FDP (SOW, Option 3, Milestone 13)

  	
   

  	
  Within six (6) months after
  manufacture.

  
	
  60.

  	
   

  	
  Final Approved Master Batch Records
  (MBRs) for Scale-Up of Diluent (SOW, Option 3, Milestone 14)

  	
   

  	
  Prior to cGMP manufacture.

  
	
  61.

  	
   

  	
  Executed Batch Manufacturing Records
  (BMRs) and Certificate of Analysis for Scale Up of Diluent (SOW, Option 3, Milestone 14)

  	
   

  	
  Within six (6) months after
  manufacture.

  
	
  62.

  	
   

  	
  Validation Master Plan (VMP) for FDP
  and Diluent (SOW, Option
  3, Milestone 15)

  	
   

  	
  Within six (6) months after
  exercising Option 3.

  
	
  63.

  	
   

  	
  FDP Process Validation Protocol (SOW, Option 3, Milestone 15)

  	
   

  	
  To be negotiated.

  
	
  64.

  	
   

  	
  Executed Batch Manufacturing Records
  (BMRs) and Certificate of Analysis for FDP Process Validation (SOW, Option 3, Milestone 15)

  	
   

  	
  Within five (5) months after
  manufacture.

  
	
  65.

  	
   

  	
  FDP Consistency Protocol with
  Validation Data and VMP (SOW, Option 3, Milestone
  16)

  	
   

  	
  To be negotiated.

  
	
  66.

  	
   

  	
  Executed Batch Manufacturing Records
  (BMRs) and Certificate of Analysis for FDP Consistency (SOW, Option 3, Milestone 16)

  	
   

  	
  To be negotiated.

  
	
  67.

  	
   

  	
  Diluent Process Validation/Consistency
  Report (SOW, Option 3,
  Milestone 17)

  	
   

  	
  To be negotiated.

  
	
  68.

  	
   

  	
  Executed Batch Manufacturing Records
  (BMRs) and Certificate of Analysis for Diluent Process Validation/Consistency
  (SOW, Option 3,
  Milestone 17)

  	
   

  	
  Within five (5) months after
  manufacture.

  
	
  69.

  	
   

  	
  200,000 Doses of cGMP FDP Vaccine and
  Associated Certificate of Analysis (SOW, Option 3, Milestone
  16)

  	
   

  	
  To be negotiated.

  
	
  70.

  	
   

  	
  200,000 Doses of cGMP FDP Diluent and
  Associated Certificate of Analysis (SOW, Option 3, Milestone
  16)

  	
   

  	
  To be negotiated.

  
	
  71.

  	
   

  	
  Validation Reports for Each In-Process
  and Release Assay for FDP (SOW, Option 3, Milestone
  18)

  	
   

  	
  To be negotiated.

  
	
  72.

  	
   

  	
  Validation Reports of the Stability of
  Non- Releasable Assays for FDP (SOW, Option 3, Milestone
  18)

  	
   

  	
  To be negotiated.

  
	
  73.

  	
   

  	
  Validation Reports for Each In-Process
  and Release Assay for Diluent (SOW, Option 3, Milestone
  19)

  	
   

  	
  To be negotiated.

  
	
  74.

  	
   

  	
  Validation Reports of the Stability of
  Non- Releasable Assays for Diluent (SOW, Option 3, Milestone
  19)

  	
   

  	
  To be negotiated.

  
	
  75.

  	
   

  	
  Validation Report of Immunopotency
  Assay (SOW, Option 3,
  Milestone 20)

  	
   

  	
  To be negotiated.

  



 


28

















 


	
  Item

  	
   

  	
  Report/Deliverable

  	
   

  	
  Delivery Schedule

  
	
  76.

  	
   

  	
  Stability Study Reports for Testing of
  FDP Process Verification (SOW, Option 3, Milestone
  21)

  	
   

  	
  To be negotiated.

  
	
  77.

  	
   

  	
  Stability Study Reports for Testing of
  FDP Process Validation (SOW, Option 3, Milestone
  21)

  	
   

  	
  To be negotiated.

  
	
  78.

  	
   

  	
  Stability Study Report for Consistency Campaign
  for FDP (SOW, Option 3,
  Milestone 21)

  	
   

  	
  To be negotiated.

  
	
  79.

  	
   

  	
  Stability Study Reports for Testing of
  Diluent GMP Lot (SOW, Option
  3, Milestone 22)

  	
   

  	
  To be negotiated.

  
	
  80.

  	
   

  	
  Stability Study Reports for Testing of
  Diluent Process Validation/Consistency (SOW, Option 3, Milestone 22)

  	
   

  	
  To be negotiated.

  
	
  81.

  	
   

  	
  Executed Batch Manufacturing Records (BMRs)
  and Certificate of Analysis for Phase II Clinical Trial (SOW, Option 4, Milestone 23)

  	
   

  	
  Within five (5) months after
  manufacture.

  
	
  82.

  	
   

  	
  Stability Study Reports for Clinical
  Batches (SOW, Option 4,
  Milestone 23)

  	
   

  	
  To be negotiated.

  
	
  83.

  	
   

  	
  Phase II Clinical Trial Audit Report
  and Quality Agreement (SOW, Option 4, Milestone
  25)

  	
   

  	
  Prior to placing orders with the CRO.

  
	
  84.

  	
   

  	
  Phase II Clinical Trial Documentation (including Protocol and Investigators Brochure) (SOW, Option 4, Milestone 25)

  	
   

  	
  To be negotiated.

  
	
  85.

  	
   

  	
  Documentation of Interactions with CBER and CBER Concurrence (SOW Option 4, Milestone 25)

  	
   

  	
  To be negotiated.

  
	
  86.

  	
   

  	
  Phase II Clinical Trial Report (SOW, Option 4, Milestone 25)

  	
   

  	
  To be negotiated.

  
	
  87.

  	
   

  	
  Passive Transfer Study Using Clinical
  Trial Material
  Documentation of Interaction with and Concurrence from the Animal Studies Group (SOW, Option
  4, Milestone 26)

  	
   

  	
  To be negotiated.

  
	
  88.

  	
   

  	
  Passive Transfer Study Using Clinical
  Trial Material
  Final Report (SOW, Option
  4, Milestone 26)

  	
   

  	
  To be negotiated.

  
	
  89.

  	
   

  	
  Human Subjects Annual IRB Report (Options 2
  and 4)

  	
   

  	
  Due annually during the Option periods.

  
	
  90.

  	
   

  	
  Annual Utilization Report

  	
   

  	
  Due on or before the 30th of the month
  following each anniversary date of the contract.

  
	
  91.

  	
   

  	
  Final Invention Statement

  	
   

  	
  Due on or before the completion date of
  the contract.

  



 


29
















 


b.              Copies of reports shall be sent to the following addressees:


 




	
  Recipient

  	
   

  	
  Address

  	
   

  	
  Item No.

  	
   

  	
  Quantity and Format

  
	
  Project Officer

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  1 hard copy, 1 electronic copy

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Contracting Officer

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  1 original, 1 electronic copy

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NIAID Regulatory Affairs designee

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  1 hard copy, 1 electronic copy

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Designated DMID Repository

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  2,000 Clinical Doses of cGMP Vaccine
  and Associated Certificate of Analysis

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Designated DMID Repository

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  2,000 Doses of cGMP Diluent and
  Associated Certificate of Analysis

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Designated DMID Repository

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  200,000 Doses of cGMP FDP Vaccine and Associated
  Certificate of Analysis

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Designated DMID Repository

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  200,000 Doses of cGMP FDP Diluent and
  Associated Certificate of Analysis

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OPERA

  	
   

  	
  [* * *]

  	
   

  	
  [* * *]

  	
   

  	
  1 hard copy

  






 


30

















 


ARTICLE F.3.  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.acquisition.gov/comp/far/index.html


 


FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER
1) CLAUSE:


 


52.242-15, Stop Work
Order (August 1989) with Alternate I
(April 1984).


 


31

















 


SECTION G
- CONTRACT ADMINISTRATION DATA


 


ARTICLE G.1.  PROJECT
OFFICER


 


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


 


[* * *]


 


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 for any costs incurred during the performance
of this contract; or (5) otherwise change any terms and conditions of this
contract.


 


The Government may unilaterally change its
Project Officer designation.


 


ARTICLE G.2.  KEY
PERSONNEL, HHSAR 352.270-5 (January 2006)


 


The key personnel specified in this contract
are considered to be essential to work performance. At least 30 days prior to
diverting any of the specified individuals to other programs or contracts (or
as soon as possible, if an individual must be replaced, for example, as a
result of leaving the employ of the Contractor), the Contractor shall notify
the Contracting Officer and shall submit comprehensive justification for the
diversion or replacement request (including proposed substitutions for key
personnel) to permit evaluation by the Government of the impact on performance
under this contract. The Contractor shall not divert or otherwise replace any
key personnel without the written consent of the Contracting Officer. The
Government may modify the contract to add or delete key personnel at the
request of the Contractor or Government.


 


(End of Clause)


 


The following individual is considered to be
essential to the work being performed hereunder:


 


	
  Name

  	
   

  	
  Title

  
	
  [***]

  	
   

  	
  Principal Investigator

  



 


32

















 


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 Contractor shall follow the attached instructions and submission
procedures specified below to meet the requirements of a “proper invoice”
pursuant to FAR Subpart 32.9, Prompt Payment.


 


1.              Invoices shall
be submitted as identified below. Do not
submit supporting documentation (e.g., receipts, time sheets, vendor invoices,
etc.) with your invoice unless specified elsewhere in the contract or requested
by the Contracting Officer.


 


a.              The original hard
copy invoice shall be submitted to the following designated billing
office:


 


National Institutes of
Health

Office of Financial Management

Commercial Accounts

2115 East Jefferson Street, Room 4B-432, MSC 8500

Bethesda, MD 20892-8500


 


b.             The Contractor shall submit an electronic copy of the invoice to the
Contracting Officer instead of a paper copy. The invoice shall be transmitted
as an attachment via e-mail to the NIAID OA central invoice e-mail address listed
below. The subject line of the e-mail must include the following
information:  Name of Contractor,
Contract Number, and Unique Invoice Number. Only one (1) invoice should be
submitted per email. The invoice should be in Adobe PDF format, though a MS Word
or MS Excel format will also be considered acceptable. [Note:  The original invoice must still be submitted
in hard copy and mailed to the designated billing office to meet the
requirements of a “proper invoice”.]

E-mail:  NIAIDOAlnvoices@niaid.nih.gov


 


2.              In addition to
the requirements specified in FAR Subpart 32.905 for a proper invoice, the
Contractor shall include the following information on the face page of all
invoices:


 


a.              Name of the Office of Acquisitions. The Office
of Acquisitions for this contract is NIAID.


 


b.             Central Point of Distribution. For the purpose
of this contract, the Central Point of Distribution is NIAIDOAInvoices.


 


c.              Federal Taxpayer Identification Number (TIN). If
the Contractor does not have a valid TIN, it shall identify the Vendor
Identification Number (VIN) on the invoice. The VIN is the number that appears
after the Contractor’s name in Block 7 on the face page of the contract. If
the Contractor has neither a TIN, DUNS, or VIN, they should contact the
Contracting Officer.


 


d.             DUNS or DUNS+4 number. The DUNS number must
identify the Contractor’s name and address exactly as stated in the contract
and as registered in the Central Contractor Registration (CCR) database. If the
Contractor does not have a valid DUNS number, it shall identify the VIN number
on the invoice. If the Contractor has neither a TIN, DUNS, or VIN, they should
contact the Contracting Officer.


 


e.              Invoice Matching Option. This contract requires
a Two-Way match.


 


33

















 


f.                Unique Invoice Number. Each invoice must be
identified by a unique invoice number, which can only be used one time
regardless of the number of contracts or orders held by an organization.


 


b.             Inquiries
regarding payment of invoices shall be directed to the designated billing
office, (301) 496-6452.


 


c.              The Contractor
shall provide a detailed breakdown on invoices of the following cost
categories:


 


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


 


b.             Fringe Benefits - Cite rate and amount.


 


c.              Overhead - Cite rate and amount.


 


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


 


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


 


f.                Consultant Fees - Identify individuals and
amounts. Cite COA, if appropriate.


 


g.             Subcontracts - Attach subcontractor invoice(s).


 


h.             Equipment - Cite COA, if appropriate, and
amount.


 


i.                 G&A - Cite rate and amount.


 


j.                 Total Cost


 


k.              Fixed Fee


 


l.                 Total Cost Plus Fixed Fee


 


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


 


Monthly
invoices must also include a Summary page along with separate pages for
costs billed per each Milestone.


 


ARTICLE G.4.  INDIRECT COST RATES


 


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


 


Director, Division of
Financial Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6100 Building, Room 6B05

6100 Executive Blvd., MSC-7540

Bethesda, MD 20892-7540


 


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


 


34

















 


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 HHS
Publication, “Contractor’s Guide for Control of Government Property,” which is
incorporated into this contract by reference. This document can be accessed at:


 


http://www.hhs.gov/oamp/policies/contractors_guide_for_control_of_gov_property.pdf.


 


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 Boulevard MSC 7670

Bethesda, MD 20892-7670

(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 shall be submitted as determined by the Project Officer and the
Contracting Officer, but at least once during the life 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://oamp.od.nih.gov/OD/CPS/cps.asp


 


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.


 


35

















 


SECTION H  - SPECIAL CONTRACT REQUIREMENTS


 


ARTICLE H.1.  HUMAN SUBJECTS


 


Research involving human subjects shall not be
conducted under this contract until the protocol developed in Phase I has been
approved by NIAID, written notice of such approval has been provided by the
Contracting Officer, and the Contractor has provided to the Contracting Officer
a properly completed “Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263
(formerly Optional Form 310) certifying IRB review and approval of the
protocol. The human subject certification can be met by submission of the
Contractor’s self designated form, provided
that it contains the information required by the “Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB
No. 0990-0263 (formerly Optional Form 310).


 


The Contractor is required to submit the Form OMB
No. 0990-0263 on an annual basis beginning with the effective date of the
contract, or the exercise of Options, as applicable.


 


When research involving human subjects will
take place at collaborating sites or other performance sites, the Contractor
shall obtain, and keep on file, a properly completed “Protection of Human
Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB
No. 0990-0263 (formerly Optional Form 310) certifying IRB review and
approval of the research.


 


ARTICLE H.2.  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.3.      DATA AND SAFETY MONITORING IN CLINICAL TRIALS


 


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


 


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

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

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


 


The Contractor must comply with the NIH Policy
cited in these NIH Announcements and any other data and safety monitoring
requirements found elsewhere in this contract.


 


36

















 


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


 


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


 


ARTICLE H.4.  REGISTRATION OF CLINICAL TRIALS IN THE GOVERNMENT DATABASE
(ClinicalTrials.gov)


 


Pursuant to Public Law 110-85, Food and Drug
Administration Amendments Act of 2007, Title VIII-Clinical Trial Databases, the
Contractor shall register the clinical trial(s) performed under this
contract in the Government database, ClinicalTrials.gov ( http://www.ClinicalTrials.gov)
by the later of December 27, 2007, or 21 days after the first patient is
enrolled.


 


Additional information is available at:  http://prsinfo.clinicaltrials.gov .


 


ARTICLE H.5.  HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)


 


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.


 


The Contractor shall provide written
documentation that all human materials obtained as a result of research
involving human subjects conducted under this contract, by collaborating sites,
or by subcontractors identified under this contract, were obtained with 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
Contractor.


 


Provision by the Contractor to the Contracting
Officer of a properly completed “Protection of Human Subjects Assurance
Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly
Optional Form 310), certifying IRB review and approval of the protocol
from which the human materials were obtained constitutes the written documentation
required. The human subject certification can be met by submission of a self
designated form, provided that it contains the information required by the “Protection
of Human Subjects Assurance Identification/IRB Certification/Declaration of
Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310).


 


ARTICLE H.6.  RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (Including Human Gene
Transfer Research)


 


All research involving Recombinant DNA
Molecules shall be conducted in accordance with the NIH Guidelines for Research
Involving Recombinant DNA Molecules (
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) and the September 24,
2007 Notice, “Reminder of NIH Policy for Enhancing the Science, Safety, and
Ethics of Recombinant DNA Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-096.html)
(and any subsequent revisions to the Guide Notice) which stipulates biosafety
and containment measures for recombinant DNA research and delineates critical,
ethical principles and key safety reporting requirements for human gene
transfer research (See Appendix M of the Guidelines). These guidelines apply to
both basic and clinical research studies.


 


The Recombinant DNA Advisory Committee (RAC) is
charged with the safety of manipulation of genetic material through the use of
recombinant DNA techniques. Prior to beginning any clinical trials involving
the transfer of recombinant DNA to humans, the trial must be registered with
the RAC. If this contract involves new protocols that contain unique and/or
novel issues, the RAC must discuss them in a public forum and then the
Institutional Biosafety Committee (IBC), the Institutional Review Board (IRB),
and the Project Officer and Contracting Officer must approve the protocol prior
to the start of the research.


 


Failure to comply with these requirements may
result in suspension, limitation, or termination of the contract for any work
related to Recombinant DNA Research or a requirement for Contracting Officer
prior approval of any or all


 


37

















 


Recombinant DNA projects under this contract. This
includes the requirements of the Standing Institutional Biosafety Committee (IBC)
(See http://www4.od.nih.gov/oba/IBC/IBCindexpg.htm ).


 


As specified in Appendix M-1-C-4 of the NIH
Guidelines, any serious adverse event must be reported immediately to the IRB,
the IBC, the Office for Human Research Protections (if applicable), and the NIH
Office for Biotechnology Activities (OBA), followed by the filing of a written
report with each office/group and copies to the Project Officer and Contracting
Officer. (http://www4.od.nih.gov/oba/rac/guidelines_02/Appendix_M.htm#_Toc7255836)


 


ARTICLE H.7.  CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH


 


Pursuant to the current HHS annual
appropriations act, the Contractor shall not use contract funds for (1) the
creation of a human embryo or embryos for research purposes; or (2) research
in which a human embryo or embryos are destroyed, discarded, or knowingly
subjected to risk of injury or death greater than that allowed for research on
fetuses in utero under 45 CFR 46.204(b) 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.


 


ARTICLE H.8.  NEEDLE EXCHANGE


 


Pursuant to the current HHS annual
appropriations act, the Contractor shall not use contract funds to carry out
any program of distributing sterile needles or syringes for the hypodermic
injection of any illegal drug.


 


ARTICLE H.9.  PRESS RELEASES


 


Pursuant to the current HHS annual
appropriations act, 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.


 


ARTICLE H.10.  DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC INFORMATION


 


Pursuant to the current HHS annual
appropriations act, the Contractor shall not use contract funds to disseminate
scientific information that is deliberately false or misleading.


 


ARTICLE H.11.  RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS


 


Pursuant to the current HHS annual
appropriations act, the Contractor shall not use contract funds to employ
workers described in section 274A(h)(3) of the Immigration and Nationality
Act, which reads as follows:


 


“(3) Definition
of unauthorized alien. - As used in this section, the term ‘unauthorized alien’
means, with respect to the employment of an alien at a particular time, that
the alien is not at that time either (A) an alien lawfully admitted for
permanent residence, or (B) authorized to be so employed by this Act or by
the Attorney General.”


 


ARTICLE H.12.  RESTRICTION ON ABORTIONS


 


Pursuant to the current HHS annual
appropriations act, the Contractor shall not use contract funds for any
abortion.


 


38

















 


ARTICLE H.13.  SALARY RATE LIMITATION LEGISLATION PROVISIONS


 


a.              Pursuant to the
current HHS annual appropriations act, the Contractor shall not use NIH Fiscal
Year funds to pay the direct salary of an individual through this contract at a
rate in excess of Executive Level I. Direct salary is exclusive of fringe
benefits, overhead and general and administrative expenses (also referred to as
“indirect costs” 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 annual salary rate
limitation 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 used to establish contract funding exceeds any salary rate
limitation subsequently established in future HHS appropriation acts.


 


b.             Payment of
direct salaries is limited to the Executive Level I rate which was in effect on
the date(s) the expense was incurred. See the following Web site for
Executive Schedule rates of pay:  http://www.opm.gov/oca/. (For current year rates, click on Salaries and Wages
/ Executive Schedule / Rates of Pay for the Executive Schedule. For prior year
rates, click on Salaries and Wages /cursor to bottom of page and select
year/ Executive Schedule / Rates of Pay for the Executive Schedule. Rates are
effective January 1 of each calendar year unless otherwise noted.)


 


ARTICLE H.14.  PRIVACY ACT, HHSAR 352.270-11 (January 2006)


 


This contract requires the Contractor to
perform one or more of the following:  (a) Design;
(b) develop; or (c) operate a Federal agency system of records to
accomplish an agency function in accordance with the Privacy Act of 1974 (Act)
(5 U.S.C. 552a(m)(1)) and applicable agency regulations. The term “system of
records” means a group of any records under the control of any agency from
which information is retrieved by the name of the individual or by some
identifying number, symbol, or other identifying particular assigned to the
individual.


 


Violations of the Act by the Contractor and/or
its employees may result in the imposition of criminal penalties (5 U.S.C.
552a(i)). The Contractor shall ensure that each of its employees knows the
prescribed rules of conduct and that each employee is aware that he/she is
subject to criminal penalties for violation of the Act to the same extent as
HHS employees. These provisions also apply to all subcontracts awarded under
this contract which require the design, development or operation of the
designated system(s) of records (5 U.S.C. 552a(m)(1)).


 


The contract work statement:  (a) Identifies the system(s) of
records and the design, development, or operation work to be performed by the
Contractor; and (b) specifies the disposition to be made of such records
upon completion of contract performance.


 


(End of clause)


 


45 CFR Part 5b contains additional
information which includes the rules of conduct and other Privacy Act
requirements and can be found at: 
http://www.access.apo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.


 


The Privacy Act System of Records applicable to
this project is Number 09-25-0200. This document is available at:  http://oma.od.nih.gov/ms/privacy/pa-files/read02systems.htm.


 


ARTICLE H.15.  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.


 


39
















 


ARTICLE H.16.  PROTECTION OF PERSONNEL WHO WORK WITH
NONHUMAN PRIMATES


 


All Contractor personnel who work with nonhuman
primates or enter rooms or areas containing nonhuman primates shall comply with
the procedures set forth in NIH Policy Manual 3044-2, entitled, “Protection of
NIH Personnel Who Work with Nonhuman Primates,” located at the following URL:


 


http://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/


 


ARTICLE H.17.  OMB CLEARANCE or CLINICAL EXEMPTION


 


In accordance with HHSAR 352.270-7, Paperwork
Reduction Act, the Contractor shall not proceed with surveys or interviews
until such time as Office of Management and Budget (OMB) Clearance for
conducting interviews has been obtained by the Project Officer and the
Contracting Officer has issued written approval to proceed.  In addition, in accordance with 5 CFR
1320.3(h)(5), this requirement may be eligible for a Clinical Exemption to OMB
Clearance requirements subject to the approval of the NIH Clinical Exemption
Review Committee (CERC).  The clinical
exemption must be obtained and written approval to proceed received from the
Project Officer and Contracting Officer before data is collected under this
contract or any subcontract.


 


ARTICLE H.18.  OPTION PROVISION


 


Unless the Government exercises its option
pursuant to the Option Clause set forth in ARTICLE I.3., the contract will
consist only of the Base Period of the Statement of Work as defined in Sections
C and F of the contract.  Pursuant to FAR
Clause 52.217-7, Option for Increased Quantity-Separately Priced Line Item set
forth in ARTICLE I.3. of this contract, the Government may, by unilateral
contract modification, require the Contractor to perform additional options set
forth in the Statement of Work and also defined in Sections C and F of the
contract.  If the Government exercises
this option, notice must be given at least 60 days prior to the completion date
of this contract, and the estimated cost plus fixed fee of the contract will be
increased as set forth in Article B.2. of this contract.


 


ARTICLE H.19.  INFORMATION SECURITY


 


The Statement of Work (SOW) requires the
Contractor to (1) develop, (2) have the ability to access, or (3) host
and/ or maintain a Federal information system(s).  Pursuant to Federal and HHS Information
Security Program Policies, the Contractor and any subcontractor performing
under this contract shall comply with the following requirements:


 


Federal Information Security Management Act of
2002 (FISMA), Title Ill, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17,
2002); http://csrc.nist.gov/drivers/documents/FISMA-final.pdf


 


a.               Information
Type


 


x
Administrative, Management and Support Information


Scientific
and Technical Research and Innovation


o Mission Based
Information


 


 


b.              Security
Categories and Levels


 


	
  Confidentiality Level:

  	
  x Low

  	
  o Moderate

  	
  o High

  
	
  Integrity Level:

  	
  o Low

  	
  x Moderate

  	
  o High

  
	
  Availability Level.

  	
  x Low

  	
  o Moderate

  	
  o High

  
	
   

  	
   

  	
   

  	
   

  
	
  Overall Level:

  	
  o Low

  	
  x Moderate

  	
  o High

  



 


40

















 


c.               Position
Sensitivity Designations


 


1.               The following
position sensitivity designations and associated clearance and investigation
requirements apply under this contract.


 


o  Level 6:  Public
Trust - High Risk (Requires Suitability Determination with a BI).  Contractor employees assigned to a Level 6
position are subject to a Background Investigation (BI)


 


o  Level 5:  Public
Trust - Moderate Risk (Requires Suitability Determination with NACIC, MBI or
LBI).  Contractor employees
assigned to a Level 5 position with no previous investigation and approval
shall undergo a National Agency Check and Inquiry Investigation plus a Credit
Check (NACIC), a Minimum Background Investigation (MBI), or a Limited
Background Investigation (LBI).


 


x  Level 1:  Non
Sensitive (Requires Suitability Determination with an NACI).  Contractor employees assigned to a Level 1
position are subject to a National Agency Check and Inquiry Investigation
(NACI).


 


2.               The Contractor
shall submit a roster, by name, position, e-mail address, phone number and
responsibility, of all staff (including subcontractor staff) working under the
contract who will develop, have the ability to access, or host and/or maintain
a Federal information system(s).  The
roster shall be submitted to the Project Officer, with a copy to the Contracting
Officer, within 14 calendar days of the effective date of the contract.  Any revisions to the roster as a result of
staffing changes shall be submitted within 15 calendar days of the change.  The Contracting Officer shall notify the
Contractor of the appropriate level of suitability investigations to be
performed.  An electronic template, “Roster
of Employees Requiring Suitability Investigations,” is available for Contractor
use at:  http://ais.nci.nihgov/forms/Suitability-roster.xls.


 


Upon receipt of the Government’s notification
of applicable Suitability Investigations required, the Contractor shall
complete and submit the required forms within 30 days of the notification.  Additional submission instructions can be
found at the “NCI Information Technology Security Policies, Background
Investigation Process” website:  http://ais.nci.nih.gov.


 


Contractor/subcontractor employees who have met
investigative requirements within the past five years may only require an
updated or upgraded investigation.


 


3.               Contractor/subcontractor
employees shall comply with the HHS criteria for the assigned position
sensitivity designations prior to performing any work under this contract.  The following exceptions apply:


 


Levels 5 and 1: 
Contractor/subcontractor employees may begin work under the contract
after the Contractor has submitted the name, position and responsibility of the
employee to the Project Officer, as described in paragraph c. (2) above.


 


Level 6: 
In special circumstances the Project Officer may request a waiver of the
pre-appointment investigation.  If the
waiver is granted, the Project Officer will provide written authorization for
the Contractor/subcontractor employee to work under the contract.


 


d.              Information
Security Training


 


The Contractor shall ensure that each
Contractor/subcontractor employee has completed the NIH Computer Security
Awareness Training course at:  http://irtsectraining.nih.gov,
prior to performing any contract work, and thereafter completing the
NIH-specified fiscal year refresher course during the period of performance of
the contract.


 


The Contractor shall maintain a listing by name
and title of each Contractor/subcontractor employee working under this contract
that has completed the NIH required training. 
Any additional security training completed by Contractor/subcontractor
staff shall be included on this listing. 
The listing of completed training shall be included in the first monthly
progress report.  (See Article C.2.
Reporting Requirements ) Any revisions to this listing as a result of staffing
changes shall be submitted with next required monthly progress report.


 


41

















 


e.               Rules of
Behavior


 


The Contractor/subcontractor employees shall
comply with the NIH Information Technology General Rules of Behavior
at:  http://irm.cit.nih.gov/security/nihitrob.html.


 


f.                 Personnel
Security Responsibilities


 


Contractor Notification
of New and Departing Employees Requiring Background Investigations


 


1.               The Contractor
shall notify the Contracting Officer, the Project Officer, and the Security
Investigation Reviewer within five (5) working
days before a new employee assumes a position that requires a
suitability determination or when an employee with a security clearance stops
working under the contract.  The
Government will initiate a background investigation on new employees requiring
security clearances and will stop pending background investigations for
employees that no longer work under the contract.


 


2.               New
employees:  Provide the name, position
title, e-mail address, and phone number of the new employee.  Provide the name, position title and
suitability level held by the former incumbent. 
If the employee is filling a new position, provide a description of the
position and the Government will determine the appropriate security level.


 


3.               Departing
employees:


 


·                  Provide the
name, position title, and security clearance level held by or pending for the
individual.


 


·                  Perform and
document the actions identified in the “Employee Separation Checklist”,
attached in Section J, ATTACHMENTS of this contract, when a
Contractor/subcontractor employee terminates work under this contract.  All documentation shall be made available to
the Project Officer and/or Contracting Officer upon request.


 


g.              Commitment to
Protect Non-Public Departmental Information Systems and Data


 


1.               Contractor
Agreement


 


The Contractor and its subcontractors
performing under this Statement of Work shall not release, publish, or disclose
non-public Departmental information to unauthorized personnel, and shall
protect such information in accordance with provisions of the following laws
and any other pertinent laws and regulations governing the confidentiality of
such information:


 


· 18 U.S.C. 641
(Criminal Code:  Public Money, Property
or Records)
 · 18 U.S.C. 1905
(Criminal Code:  Disclosure of
Confidential Information)
 · Public
Law 96-511 (Paperwork Reduction Act)


 


2.               Contractor-Employee
Non-Disclosure Agreements


 


Each Contractor/subcontractor employee who may
have access to non-public Department information under this contract shall
complete the Commitment to Protect Non-Public Information - Contractor
Agreement.  A copy of each signed and
witnessed Non-Disclosure agreement shall be submitted to the Project Officer
prior to performing any work under the contract.


 


h.              NIST SP 800-53
Self-Assessment


 


The Contractor shall annually update and
re-submit its Self-Assessment required by NIST SP 800-53, Recommended Security Controls for Federal Information
Systems. 
(http://csrc.nist.gov/publications - under Special Publications).


 


42

















 


Subcontracts: 
The Contractor’s annual update to its Self-Assessment Questionnaire
shall include similar information for any subcontractor that performs under the
Statement of Work to (1) develop a Federal information system(s) at
the Contractor’s/subcontractor’s facility, or (2) host and/or maintain a
Federal information system(s) at the Contractor’s/subcontractor’s
facility.


 


The annual update shall be submitted to the
Project Officer, with a copy to the Contracting Officer.  For the option periods:  no later than the completion date of the
option period of performance.


 


i.                  Information
System Security Plan


 


The Contractor’s draft ISSP submitted with its
proposal shall be finalized in coordination with the Project Officer no later
than 90 calendar days after contract award.


 


Following approval of its draft ISSP, the
Contractor shall update and resubmit its ISSP to the Project Officer every
three (3) years or when a major modification has been made to its internal
system.  The Contractor shall use the
current ISSP template in Appendix A of NIST SP 800-18, Guide to Developing
Security Plans for Federal Information Systems. 
(http://csrc.nist.gov/publications/nistpubs/800-18-Rev1/sp800-18-Rev1-final.pdf).  The details contained in the Contractor’s
ISSP shall be commensurate with the size and complexity of the requirements of
the Statement of Work based on the System Categorization determined above in
subparagraph (b) Security Categories and Levels of this Article.


 


Subcontracts: 
The Contractor shall include similar information for any subcontractor
performing under the Statement of Work with the Contractor whenever the
submission of an ISSP is required.


 


j.                  Common Security
Configurations


 


The Contractor shall ensure that any
information technology acquired under this contract incorporates the applicable
common security configuration established by the National Institute of
Standards and Technology (NIST) at http://checklists.nist.gov.


 


ARTICLE H.20.  ELECTRONIC AND INFORMATION TECHNOLOGY
ACCESSIBILITY (January 2008)


 


Pursuant to Section 508 of the
Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce
Investment Act of 1998, all electronic and information technology (EIT)
products and services developed, acquired, maintained, and/or used under this
contract/order must comply with the “Electronic and Information Technology
Accessibility Provisions” set forth by the Architectural and Transportation
Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR
part 1194.  Information about Section 508
provisions is available at http:// www.section508.gov/.  The complete text of Section 508 Final
provisions can be accessed at http://www.access-board.gov/sec508/provisions.htm.


 


The Section 508 standards applicable to
this contract/order are identified in the Statement of Work.  The Contractor must provide a written Section 508
conformance certification due at the end of each order/contract exceeding
$100,000 when the order/contract duration is one year or less.  If it is determined by the Government that
EIT products and services provided by the Contractor do not conform to the
described accessibility in the Product Assessment Template, remediation of the
products and/or services to the level of conformance specified in the vendor’s
Product Assessment Template will be the responsibility of the Contractor at its
own expense.


 


In the event of a modification(s) to the
contract/order, which adds new EIT products and services or revised the type
of, or specifications for, products and services the Contractor is to provide,
including EIT deliverables such as electronic documents and reports.  The Contracting Officer may require that the
Contractor submit a completed HHS Section 508 Product Assessment Template
to assist the Government in determining that the EIT products and services
support Section 508 accessibility requirements.  Instructions for documenting accessibility
via the HHS Section 508 Product Assessment Template may be found at
http://508 hhs gov.


 


[End of HHSAR 352.270-19(b)]


 


43

















 


Prior to the Contracting Officer exercising an
option for a subsequent performance period/additional quantity or adding
increment funding for a subsequent performance period under this contract, as
applicable, the Contractor must provide a Section 508 Annual Report to the
Contracting Officer and Contracting Officer’s Technical Representative (also
known as Project Officer or Contracting Officer’s Representative).  Unless otherwise directed by the Contracting
Officer in writing, the Contractor shall provide the cited report in accordance
with the following schedule. 
Instructions for completing the report are available at:  http://508.hhs.gov/ under the heading Vendor
Information and Documents.  The
Contractor’s failure to submit a timely and properly completed report may
jeopardize the Contracting Officer’s exercising an option or adding incremental
funding, as applicable.


 


Schedule for Contractor
Submission of Section 508 Annual Report:  To be included with the Annual Progress
Report.


 


[End of HHSAR 352.270-19(c)]


 


ARTICLE H.21.  INSTITUTIONAL RESPONSIBILITY REGARDING
CONFLICTING INTERESTS OF INVESTIGATORS


 


The Contractor shall comply with the
requirements of 45 CFR Part 94, Responsible Prospective Contractors, which
promotes objectivity in research by establishing standards to ensure that
investigators (defined as the principal investigator and any other person who
is responsible for the design, conduct, or reporting of research funded under
NIH contracts) will not be biased by any conflicting financial interest.  45 CFR Part 94 is available at the
following


Web site: 
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=cc7504e541


bc62939c52389e9afc27d5&rgn=div5&view=text&node=45:1.0.1.1.51 &idno=45


 


As required by 45 CFR Part 94, the
Contractor shall, at a minimum:


 


a.               Maintain a
written, enforceable policy on conflict of interest that complies with 45 CFR Part 94
and inform each investigator of the policy, the investigator’s reporting
responsibilities, and the applicable regulations.  The Contractor must take reasonable steps to
ensure that investigators working as collaborators or subcontractors comply
with the regulations.


 


b.              Designate an
official(s) to solicit and review financial disclosure statements from
each investigator participating in NIH-funded research.  Based on established guidelines consistent
with the regulations, the designated official(s) must determine whether a
conflict of interest exists, and if so, determine what actions should be taken
to manage, reduce, or eliminate such conflict. 
A conflict of interest exists when the designated official(s) reasonably
determines that a Significant Financial
Interest could directly and significantly affect the design,
conduct, or reporting of the NIH-funded research.  The Contractor may require the management of
other conflicting financial interests in addition to those described in this
paragraph, as it deems appropriate. 
Examples of conditions or restrictions that might be imposed to manage
actual or potential conflicts of interests are included in 45 CFR Part 94,
under Management of Conflicting Interests.


 


c.               Require all
financial disclosures to be updated during the period of the award, either on
an annual basis or as new reportable Significant Financial Interests are
obtained.


 


d.              Maintain
records, identifiable to each award, of all financial disclosures and all
actions taken by the Contractor with respect to each conflicting interest 3
years after final payment or, where applicable, for the other time periods
specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.


 


e.               Establish
adequate enforcement mechanisms and provide for sanctions where appropriate.


 


If a conflict of interest is identified, the
Contractor shall report to the Contracting Officer, the existence of the
conflicting interest found.  This report
shall be made and the conflicting interest managed, reduced, or eliminated, at
least on a temporary basis, within sixty (60) days of that identification.


 


If the failure of an investigator to comply
with the conflict of interest policy has biased the design, conduct, or
reporting of the NIH-funded research, the Contractor must promptly notify the
Contracting Officer of the corrective action taken or to be taken.  The Contracting Officer will take appropriate
action or refer the matter to the Contractor for


 


44

















 


further action, which may include directions to
the Contractor on how to maintain appropriate objectivity in the funded
research.


 


The Contracting Officer may at any time inquire
into the Contractor’s procedures and actions regarding conflicts of interests
in NIH-funded research, including a review of all records pertinent to
compliance with 45 CFR Part 94.  The
Contracting Officer may require submission of the records or review them on
site.  On the basis of this review, the
Contracting Officer may decide that a particular conflict of interest will bias
the objectivity of the NIH-funded research to such an extent that further
corrective action is needed or that the Contractor has not managed, reduced, or
eliminated the conflict of interest.  The
issuance of a Stop Work Order by the Contracting Officer may be necessary until
the matter is resolved.


 


If the Contracting Officer determines that
NIH-funded clinical research, whose purpose is to evaluate the safety or
effectiveness of a drug, medical device, or treatment, has been designed,
conducted, or reported by an investigator with a conflict of interest that was
not disclosed or managed, the Contractor must require disclosure of the
conflict of interest in each public presentation of the results of the
research.


 


ARTICLE H.22.  PUBLICATION AND PUBLICITY


 


In addition to the requirements set forth in
HHSAR Clause 352.270-6, Publications and
Publicity incorporated by reference in SECTION I of this
contract, 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. HHSN272200800049C”


 


ARTICLE H.23.  REPORTING MATTERS INVOLVING FRAUD, WASTE AND
ABUSE


 


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


 


Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026


 


ARTICLE H.24.  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.


 


45

















 


ARTICLE H.25.   SHARING RESEARCH DATA


 


The data sharing plan submitted by the
Contractor is acceptable.  The Contractor
agrees to adhere to its plan and shall request prior approval of the
Contracting Officer for any changes in its plan.


 


The NIH endorses the sharing of final research
data to serve health.  This contract is
expected to generate research data that must be shared with the public and
other researchers.  NIH’s data sharing
policy may be found at the following Web site:


 


http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html


 


NIH recognizes that data sharing may be
complicated or limited, in some cases, by institutional policies, local IRB
rules, as well as local, state and Federal laws and regulations, including the
Privacy Rule (see HHS-published documentation on the Privacy Rule at http://www.hhs.gov/ocr/).  The rights and privacy of people who
participate in NIH-funded research must be protected at all times; thus, data
intended for broader use should be free of identifiers that would permit
linkages to individual research participants and variables that could lead to
deductive disclosure o the identity of individual subjects.


 


ARTICLE H.26.   POSSESSION USE AND TRANSFER OF SELECT
BIOLOGICAL AGENTS OR TOXINS


 


The Contractor shall not conduct work involving
select agents or toxins under this contract until it and any associate
subcontractors comply with the following:


 


For prime or subcontract awards to domestic institutions
that possess, use, and/or transfer Select Agents under this contract, the
institution must comply with the provisions of 42 CFR part 73, 7 CFR part 331,
and/or 9 CFR part 121 ( http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf
) as required, before using NIH funds for work involving a Select Agent or Toxin.  No NIH funds can be used for research involving a Select Agent or Toxin at a domestic institution without a valid registration
certificate.


 


For prime or subcontract awards to foreign institutions
that possess, use, and/or transfer a Select
Agent or Toxin, before
using NIH funds for any work directly involving a Select Agent or Toxin,
the foreign institution must provide information satisfactory to the NIAID that
safety, security, and training standards equivalent to those described in 42
CFR part 73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be
administered on behalf of all Select Agent
or Toxin work supported by these
funds.  The process for making this
determination includes inspection of the foreign laboratory facility by an
NIAID representative.  During this
inspection, the foreign institution must provide the following
information:  concise summaries of
safety, security, and training plans; names of individuals at the foreign
institution who will have access to the Select Agents and procedures for
ensuring that only approved and appropriate individuals, in accordance with
institution procedures, will have access to the Select Agents under the
contract; and copies of or links to any applicable laws, regulations, policies,
and procedures applicable to that institution for the safe and secure
possession, use, and/or transfer of select agents.  No NIH
funds can be used for work involving a Select
Agent or Toxin at a
foreign institution without written approval from the Contracting Officer.


 


Listings of HHS select agents and toxins, and
overlap select agents or toxins as well as information about the registration
process for domestic institutions, are available on the Select Agent Program
Web site at http://www:cdc.gov/od/sap/ and
http://www.cdc.gov/od/sap/docs/salist.pdf


 


Listings of USDA select agents and toxins as
well as information about the registration process for domestic institutions
are available on the APHIS/USDA website at: 
http://www.aphis_usda.gov/programs/ag_selectagent/index.html and:

http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html


 


For foreign institutions, see the NIAID Select
Agent Award information:

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


 


46

















 


ARTICLE H.27.  POSSESSION, USE OR TRANSFER OF A HIGHLY
PATHOGENIC AGENT


 


The work being conducted under this contract
may involve the possession, use, or transfer of a Highly Pathogenic Infectious Agent (HPA).  The NIAID defines an HPA as a pathogen that,
under any circumstances, warrants a biocontainment safety level of BSL3 or
higher according to either:


 


1.               The current
edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories
(BMBL)


(http://
www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm);


 


2.               The Contractor’s
Institutional Biosafety Committee (IBC) or equivalent body; or


 


3.               The Contractor’s
appropriate designated institutional biosafety official.


 


If there is ambiguity in the BMBL guidelines
and/or there is disagreement among the BMBL, an IBC or equivalent body, or
institutional biosafety official, the highest recommended containment level
must be used.


 


ARTICLE H.28.  HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L.
101-391)


 


Pursuant to Public Law 101-391, no Federal
funds may be used to sponsor or fund in whole or in part a meeting, convention,
conference or training seminar that is conducted in, or that otherwise uses the
rooms, facilities, or services of a place of public accommodation that do not
meet the requirements of the fire prevention and control guidelines as
described in the Public Law.  This
restriction applies to public accommodations both foreign and domestic.


 


Public accommodations that meet the
requirements can be accessed at: 
http://www.usfa.fema.gov/hotel/index.htm.


 


ARTICLE H.29.  PROHIBITION ON CONTRACTOR INVOLVEMENT WITH
TERRORIST ACTIVITIES


 


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


 


ARTICLE H.30.  NIH POLICY ON ENHANCING PUBLIC ACCESS TO
ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH


 


Beginning April 7, 2008, NIH-funded
investigators shall submit to the NIH National Library of Medicine’s (NLM)
PubMed Central (PMC) an electronic version of the author’s final manuscript,
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH.  NIH
defines the author’s final manuscript as the final version accepted for journal
publication, and includes all modifications from the publishing peer review
process.  The PMC archive will preserve
permanently these manuscripts for use by the public, health care providers,
educators, scientists, and NIH.  The
Policy directs electronic submissions to the NIH/NLM/PMC:  http://www.pubmedcentral.nih.gov.


 


Additional information is available at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html.


 


47

















 


PART II
- CONTRACT CLAUSES


 


SECTION I - CONTRACT
CLAUSES


 


General Clauses for a
Cost-Reimbursement Research and Development Contract


 


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.amet.gov/far/.


 


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


 


	
  FAR

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
  52.202-1

  	
   

  	
  Jul 2004

  	
   

  	
  Definitions (Over $100,000)

  
	
  52.203-3

  	
   

  	
  Apr 1984

  	
   

  	
  Gratuities (Over $100,000)

  
	
  52.203-5

  	
   

  	
  Apr 1984

  	
   

  	
  Covenant Against Contingent
  Fees (Over $100,000)

  
	
  52.203-6

  	
   

  	
  Sep 2006

  	
   

  	
  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

  	
   

  	
  Sep 2007

  	
   

  	
  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)

  
	
  52.204-7

  	
   

  	
  Apr 2008

  	
   

  	
  Central Contractor
  Registration

  
	
  52.204-10

  	
   

  	
  Sep 2007

  	
   

  	
  Reporting Subcontract
  Awards ($500,000,000 or more)

  
	
  52.209-6

  	
   

  	
  Sep 2006

  	
   

  	
  Protecting the Government’s
  Interests When Subcontracting With Contractors Debarred, Suspended, or
  Proposed for Debarment (Over $30,000)

  
	
  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 (Over $650,000)

  
	
  52.215-12

  	
   

  	
  Oct 1997

  	
   

  	
  Subcontractor Cost or
  Pricing Data (Over $650,000)

  
	
  52.215-14

  	
   

  	
  Oct 1997

  	
   

  	
  Integrity of Unit Prices
  (Over $100,000)

  
	
  52.215-15

  	
   

  	
  Oct 2004

  	
   

  	
  Pension Adjustments and
  Asset Reversions

  
	
  52.215-18

  	
   

  	
  Jul 2005

  	
   

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

  
	
  52.215-19

  	
   

  	
  Oct 1997

  	
   

  	
  Notification of Ownership
  Changes

  
	
  52.215-21

  	
   

  	
  Oct 1997

  	
   

  	
  Requirements for Cost or
  Pricing Data or Information Other Than Cost or Pricing Data - Modifications

  
	
  52.216-7

  	
   

  	
  Dec 2002

  	
   

  	
  Allowable Cost and Payment

  
	
  52.216-8

  	
   

  	
  Mar 1997

  	
   

  	
  Fixed Fee

  
	
  52.219-8

  	
   

  	
  May 2004

  	
   

  	
  Utilization of Small
  Business Concerns (Over $100,000)

  
	
  52.219-9

  	
   

  	
  Apr 2008

  	
   

  	
  Small Business
  Subcontracting Plan (Over $550,000, $1,000 000 for Construction)

  



 


48

















 


	
  FAR

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
  52.219-16

  	
   

  	
  Jan 1999

  	
   

  	
  Liquidated Damages -
  Subcontracting Plan (Over $550,000, $1,000,000 for Construction)

  
	
  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

  
	
  52.222-21

  	
   

  	
  Feb 1999

  	
   

  	
  Prohibition of Segregated
  Facilities

  
	
  52.222-26

  	
   

  	
  Mar 2007

  	
   

  	
  Equal Opportunity

  
	
  52.222-35

  	
   

  	
  Sep 2006

  	
   

  	
  Equal Opportunity for
  Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
  Veterans (Over $100,000)

  
	
  52.222-36

  	
   

  	
  Jun 1998

  	
   

  	
  Affirmative Action for
  Workers with Disabilities

  
	
  52.222-37

  	
   

  	
  Sep 2006

  	
   

  	
  Employment Reports on
  Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
  Veterans (Over $100,000)

  
	
  52.222-50

  	
   

  	
  Aug 2007

  	
   

  	
  Combating Trafficking in
  Persons

  
	
  52.223-6

  	
   

  	
  May 2001

  	
   

  	
  Drug-Free Workplace

  
	
  52.223-14

  	
   

  	
  Aug 2003

  	
   

  	
  Toxic Chemical Release
  Reporting (Over $100,000)

  
	
  52.225-1

  	
   

  	
  Jun 2003

  	
   

  	
  Buy American Act - Supplies

  
	
  52.225-13

  	
   

  	
  Jun 2008

  	
   

  	
  Restrictions on Certain
  Foreign Purchases

  
	
  52.227-1

  	
   

  	
  Dec 2007

  	
   

  	
  Authorization and Consent,
  Alternate I (Apr 1984)

  
	
  52.227-2

  	
   

  	
  Dec 2007

  	
   

  	
  Notice and Assistance
  Regarding Patent and Copyright Infringement

  
	
  52.227-11

  	
   

  	
  Dec 2007

  	
   

  	
  Patent Rights - Ownership
  by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph
  (e) is modified to include the requirements in FAR
  27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is
  annual.

  
	
  52.227-14

  	
   

  	
  Dec 2007

  	
   

  	
  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

  	
   

  	
  Oct 2003

  	
   

  	
  Prompt Payment, Alternate I
  (Feb 2002)

  
	
  52.232-33

  	
   

  	
  Oct 2003

  	
   

  	
  Payment by Electronic Funds
  Transfer—Central Contractor Registration

  
	
  52.233-1

  	
   

  	
  Jul 2002

  	
   

  	
  Disputes

  
	
  52.233-3

  	
   

  	
  Aug 1996

  	
   

  	
  Protest After Award,
  Alternate I (Jun 1985)

  
	
  52.233-4

  	
   

  	
  Oct 2004

  	
   

  	
  Applicable Law for Breach
  of Contract Claim

  
	
  52.242-1

  	
   

  	
  Apr 1984

  	
   

  	
  Notice of Intent to Disallow
  Costs

  
	
  52.242-3

  	
   

  	
  May 2001

  	
   

  	
  Penalties for Unallowable
  Costs (Over $650,000)

  
	
  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

  	
   

  	
  Jun 2007

  	
   

  	
  Subcontracts, Alternate
  I(June 2007)

  
	
  52.244-5

  	
   

  	
  Dec 1996

  	
   

  	
  Competition in
  Subcontracting (Over $100,000)

  
	
  52.244-6

  	
   

  	
  Mar 2007

  	
   

  	
  Subcontracts for Commercial
  Items

  



 


49

















 


	
  FAR

  	
   

  	
   

  	
   

  	
   

  
	
  CLAUSE NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
  52.245-1

  	
   

  	
  Jun 2007

  	
   

  	
  Government Property

  
	
  52.245-9

  	
   

  	
  Jun 2007

  	
   

  	
  Use and Charges

  
	
  52.246-23

  	
   

  	
  Feb 1997

  	
   

  	
  Limitation of Liability
  (Over $100,000)

  
	
  52.249-6

  	
   

  	
  May 2004

  	
   

  	
  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 2006

  	
   

  	
  Definitions - with
  Alternate paragraph (h) (Jan 2006)

  
	
  352.216-72

  	
   

  	
  Jan 2006

  	
   

  	
  Additional Cost Principles

  
	
  352.228-7

  	
   

  	
  Dec 1991

  	
   

  	
  Insurance - Liability to
  Third Persons

  
	
  352.232-9

  	
   

  	
  Jan 2006

  	
   

  	
  Withholding of Contract
  Payments

  
	
  352.233-70

  	
   

  	
  Jan 2006

  	
   

  	
  Litigation and Claims

  
	
  352.242-71

  	
   

  	
  Apr 1984

  	
   

  	
  Final Decisions on Audit
  Findings

  
	
  352.270-5

  	
   

  	
  Jan 2006

  	
   

  	
  Key Personnel

  
	
  352.270-6

  	
   

  	
  Jan 2006

  	
   

  	
  Publications and Publicity

  
	
  352.270-10

  	
   

  	
  Jan 2006

  	
   

  	
  Anti-Lobbying (Over
  S100,000)

  



 


[End of GENERAL CLAUSES FOR A
NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 08/2008].


 


50

















 


ARTICLE I.2 AUTHORIZED
SUBSTITUTION OF CLAUSES


 


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


 


a.               FAR
Clauses 52.215-15, Pension Adjustments
And Asset Reversions (October 2004); 52.215-18, Reversion Or
Adjustment Of Plans For Post Retirement Benefits (PRB) Other Than Pensions
(July 2005); and, 52.215-19, Notification
Of Ownership Changes (October 1997), are deleted in their
entirety.


 


b.              Alternate IV (October 1997) of FAR Clause 52.215-21,
Requirements For Cost Or Pricing Data Or Information Other Than Cost Or Pricing
Data—Modifications (October 1997) is added.


 


c.               FAR
Clauses 52.219-9, Small Business
Subcontracting Plan (April 2008), and 52.219-16, Liquidated Damages—Subcontracting Plan
(January 1999) are deleted in their entirety.


 


d.              FAR
Clause 52.232-20, Limitation Of Cost
(April 1984), 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.


 


51
















 


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
Clause 52.203-13, Contractor Code of
Business Ethics and Conduct (December 2007).


 


2.               FAR
Clause 52.203-14, Display of Hotline
Poster(s) (December 2007).


 


“.....(3) Any required posters may be
obtained as follows:


 




	
  Poster(s)

  	
   

  	
  Obtain From”

  
	
  HHS Contractor Code of Ethics and 

  Business Conduct Poster

  	
   

  	
  http://www.oig.hhs.gov/hotline/OIG_Hotline_Poster.pdf

  






 


3.               FAR
Clause 52.215-17, Waiver of Facilities
Capital Cost of Money (October 1997).


 


4.               FAR
Clause 52.217-7, Option for Increased
Quantity - Separately Priced Line Item (March 1989).


 


“....The Contracting Officer may exercise the
option by written notice to the Contractor within 60 calendar days .”


 


5.               FAR
Clause 52.219-4, Notice of Price Evaluation
Preference for HUBZone Small Business Concerns (July 2005).


 


“(c) Waiver of evaluation preference.....

o Offeror elects to waive the evaluation
preference.”


 


6.               FAR
Clause 52.222-29, Notification of Visa
Denial (June 2003).


 


7.               FAR
Clause 52.223-3, Hazardous Material
Identification and Material Safety Data (January 1997), with Alternate I (July 1995).


 


8.               FAR
Clause 52.224-1, Privacy Act
Notification (April 1984).


 


9.               FAR
Clause 52.224-2, Privacy Act
(April 1984).


 


10.         Alternate II (December 2007), FAR Clause 52.227-14, Rights in Data—General (December 2007).


 


Additional purposes for which the limited
rights data may be used are:


 


None.


 


52

















 


11.         Alternate III (December 2007), FAR Clause 52.227-14, Rights in Data–General (December 2007).


 


Additions to, or limitations on, the restricted
rights set forth in the Restricted Rights Notice of subparagraph (g)(4) of
the clause are expressly stated as follows: 
None.


 


12.         Alternate V (December 2007), FAR Clause 52.227-14, Rights in Data—General (December 2007).


 


Specific data items that are not subject to
paragraph (j) include:  None.


 


13.         FAR
Clause 52.227-16, Additional Data
Requirements (June 1987).


 


14.         FAR
Clause 52.227-17, Rights in Data—Special
Works (December 2007).


 


15.         FAR
Clause 52.227-23, Rights to Proposal
Data (Technical) (June 1987).


 


Excluded pages from the proposal are
identified as follows:


 


None.


 


16.         FAR
Clause 52.229-8, Taxes-Foreign
Cost-Reimbursement Contracts (March 1990).


 


17.         FAR
Clause 52.239-1, Privacy or Security
Safeguards (August 1996).


 


18.         FAR
Clause 52.242-3, Penalties for
Unallowable Costs (May 2001).


 


19.         FAR
Clause 52.247-63, Preference for U.S.
Flag Air Carriers (June 2003).


 


20.         FAR
Clause 52.247-68, Report of Shipment
(REPSHIP) (February 2006).


 


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


 


1.               HHSAR
Clause 352.223-70, Safety and Health
(January 2006).


 


2.               HHSAR
Clause 352.270-1, Accessibility of
Meetings, Conferences and Seminars to Persons with Disabilities (January 2001).


 


3.               HHSAR
Clause 352.270-7, Paperwork Reduction
Act (January 2006).


 


4.               HHSAR
Clause 352.270-8(b), Protection of Human
Subjects (January 2006).


 


5.               HHSAR
Clause 352.270-9(b), Care of Live
Vertebrate Animals (January 2006).


 


6.               HHSAR
Clause 352.333-7001, Choice of Law
(Overseas) (March 2005).


 


53

















 


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).


 


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


 


54

















 


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 52.219-28, Post-Award Small
Business Program Representation (June 2007).


 


(a) Definitions.  As used in this clause—


 


Long-term contract means a
contract of more than five years in duration, including options.  However, the term does not include contracts
that exceed five years in duration because the period of performance has been
extended for a cumulative period not to exceed six months under the clause at
52.217-8, Option to Extend Services, or other appropriate authority.


 


Small business concern means a
concern, including its affiliates, that is independently owned and operated,
not dominant in the field of operation in which it is bidding on Government
contracts, and qualified as a small business under the criteria in 13 CFR part
121 and the size standard in paragraph (c) of this clause.


 


(b) If the Contractor represented that it
was a small business concern prior to award of this contract, the Contractor
shall rerepresent its size status according to paragraph (e) of this
clause or, if applicable, paragraph (g) of this clause, upon the
occurrence of any of the following:


 


(1) Within 30 days after execution of a
novation agreement or within 30 days after modification of the contract to
include this clause, if the novation agreement was executed prior to inclusion
of this clause in the contract.


 


(2) Within 30 days after a merger or
acquisition that does not require a novation or within 30 days after
modification of the contract to include this clause, if the merger or
acquisition occurred prior to inclusion of this clause in the contract.


 


(3) For long-term contracts


 


(i) Within 60 to 120 days prior to the end
of the fifth year of the contract; and


 


(ii) Within 60 to 120 days prior to the
exercise date specified in the contract for any option thereafter.


 


(c) The Contractor shall rerepresent its
size status in accordance with the size standard in effect at the time of this
rerepresentation that corresponds to the North American Industry Classification
System (NAICS) code assigned to this contract. 
The small business size standard corresponding to this NAICS code can be
found at http://www.sba.gov/services/contractingopportunities/sizestandardstopics/.


 


(d) The small business size standard for a
Contractor providing a product which it does not manufacture itself, for a
contract other than a construction or service contract, is 500 employees.


 


(e) Except as provided in paragraph (g) of
this clause, the Contractor shall make the rerepresentation required by
paragraph (b) of this clause by validating or updating all its
representations in the Online Representations and Certifications Application
and its data in the Central Contractor Registration, as necessary, to ensure
they reflect current status.  The
Contractor shall notify the contracting office by e-mail, or otherwise in
writing, that the data have been validated or updated, and provide the date of
the validation or update.


 


(f) If the Contractor represented that it
was other than a small business concern prior to award of this contract, the
Contractor may, but is not required to, take the actions required by paragraphs
(e) or (g) of this clause.


 


(g) If the Contractor does not have
representations and certifications in ORCA, or does not have a representation
in ORCA for the NAICS code applicable to this contract, the Contractor is
required to complete


 


55

















 


the following rerepresentation and submit it to
the contracting office, along with the contract number and the date on which
the rerepresentation was completed:


 


The Contractor represents that it is a small
business concern under NAICS Code assigned to contract number.  (End of clause)


 


b.              FAR Clause 52.222-39, Notification Of Employee Rights Concerning
Payment Of Union Dues Or Fees (December 2004)


 


(a) Definition.  As used in this clause—


 


United States means the
50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands,
American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.


 


(b) Except as
provided in paragraph (e) of this clause, during the term of this
contract, the Contractor shall post a notice, in the form of a poster,
informing employees of their rights concerning union membership and payment of
union dues and fees, in conspicuous places in and about all its plants and
offices, including all places where notices to employees are customarily
posted.  The notice shall include the following
information (except that the information pertaining to National Labor Relations
Board shall not be included in notices posted in the plants or offices of
carriers subject to the Railway Labor Act, as amended (45 U.S.C. 151-188)).


 


Notice to Employees


 


Under
Federal law, employees cannot be required to join a union or maintain
membership in a union in order to retain their jobs.  Under certain conditions, the law permits a
union and an employer to enter into a union-security agreement requiring employees
to pay uniform periodic dues and initiation fees.  However, employees who are not union members
can object to the use of their payments for certain purposes and can only be
required to pay their share of union costs relating to collective bargaining, contract
administration, and grievance adjustment.


 


If
you do not want to pay that portion of dues or fees used to support activities
not related to collective bargaining, contract administration, or grievance
adjustment, you are entitled to an appropriate reduction in your payment.  If you believe that you have been required to
pay dues or fees used in part to support activities not related to collective
bargaining, contract administration, or grievance adjustment, you may be
entitled to a refund and to an appropriate reduction in future payments.


 


For
further information concerning your rights, you may wish to contact the
National Labor Relations Board (NLRB) either at one of its Regional offices or
at the following address or toll free number:


 


National Labor
Relations Board

Division of Information

1099 14th Street, N.W.

Washington, DC 20570

1-866-667-6572

1-866-316-6572 (TTY)


 


To locate the nearest
NLRB office, see NLRB’s website at http://www.nlrb gov.


 


(c) The Contractor
shall comply with all provisions of Executive Order 13201 of February 17,
2001, and related implementing regulations at 29 CFR part 470, and orders of
the Secretary of Labor.


 


(d) In the event
that the Contractor does not comply with any of the requirements set forth in
paragraphs (b), (c), or (g), the Secretary may direct that this contract be
cancelled, terminated, or suspended in whole or in part, and declare the
Contractor ineligible for further Government contracts in accordance with
procedures at 29 CFR part 470, Subpart B—Compliance Evaluations, Complaint
Investigations and Enforcement Procedures. 
Such other sanctions or remedies may be imposed


 


56

















 


as are provided by 29
CFR part 470, which implements Executive Order 13201, or as are otherwise
provided by law.


 


(e) The
requirement to post the employee notice in paragraph (b) does not apply to—


 


(1) Contractors
and subcontractors that employ fewer than 15 persons;


 


(2) Contractor
establishments or construction work sites where no union has been formally
recognized by the Contractor or certified as the exclusive bargaining
representative of the Contractor’s employees;


 


(3) Contractor
establishments or construction work sites located in a jurisdiction named in
the definition of the United States in which the law of that jurisdiction
forbids enforcement of union-security agreements;


 


(4) Contractor
facilities where upon the written request of the Contractor, the Department of
Labor Deputy Assistant Secretary for Labor-Management Programs has waived the
posting requirements with respect to any of the Contractor’s facilities if the
Deputy Assistant Secretary finds that the Contractor has demonstrated that—


 


(i) The facility is in all respects
separate and distinct from activities of the Contractor related to the
performance of a contract; and


 


(ii) Such a waiver will not interfere with
or impede the effectuation of the Executive order; or


 


(5) Work outside
the United States that does not involve the recruitment or employment of
workers within the United States.


 


(f) The Department
of Labor publishes the official employee notice in two variations; one for
contractors covered by the Railway Labor Act and a second for all other
contractors.  The Contractor shall—


 


(1) Obtain the
required employee notice poster from the Division of Interpretations and
Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200
Constitution Avenue, NW, Room N-5605, Washington, DC 2021, or from any
field office of the Department’s Office of Labor-Management Standards or Office
of Federal Contract Compliance Programs;


 


(2) Download a
copy of the poster from the Office of Labor-Management Standards website at http://www.olms.dol.gov;
or


 


(3) Reproduce and
use exact duplicate copies of the Department of Labor’s official poster.


 


(g) The Contractor
shall include the substance of this clause in every subcontract or purchase
order that exceeds the simplified acquisition threshold, entered into in
connection with this contract, unless exempted by the Department of Labor
Deputy Assistant Secretary for Labor-Management Programs on account of special
circumstances in the national interest under authority of 29 CFR 470.3(c).  For indefinite quantity subcontracts, the
Contractor shall include the substance of this clause if the value of orders in
any calendar year of the subcontract is expected to exceed the simplified
acquisition threshold.  Pursuant to 29
CFR part 470, Subpart B—Compliance Evaluations, Complaint Investigations and
Enforcement Procedures, the Secretary of Labor may direct the Contractor to
take such action in the enforcement of these regulations, including the
imposition of sanctions for noncompliance with respect to any such subcontract
or purchase order.  If the Contractor
becomes involved in litigation with a subcontractor or vendor, or is threatened
with such involvement, as a result of such direction, the Contractor may
request the United States, through the Secretary of Labor, to enter into such
litigation to protect the interests of the United States


 


(End of Clause)


 


57

















 


PART III
- LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS


 


SECTION J - LIST OF
ATTACHMENTS


 


The following documents are attached and
incorporated in this contract:


 


1.  Statement of Work


 


Statement of Work, dated September 25,
2008, 17 pages.


 


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


 


Invoice/Financing Request and Contract
Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts,
NIH(RC)-4, (5/07), 6 pages.


 


3.  Inclusion Enrollment Report


 


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


 


4.  Annual Technical Progress Report Format for
Each Study


 


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


 


5.  Safety and Health


 


Safety and Health, HHSAR Clause 352.223-70,
(1/06), 1 page.


 


6.  Procurement of Certain Equipment


 


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


 


7.  Research Patient Care Costs


 


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


 


8.  Disclosure of Lobbying Activities, SF-LLL


 


Disclosure of Lobbying Activities, SF-LLL,
dated 7/97, 2 pages.


 


9.  Commitment To Protect Non-Public Information


 


Commitment To Protect Non-Public Information, 1
page.  Located at:  http://irm.cit.nih.gov/security/Nondisclosure.pdf


 


10.  Roster of Employees Requiring Suitability
Investigations


 


Roster of Employees Requiring Suitability
Investigations, 1 page.  Excel file located
at:


http://ais.nci.nih.gov/forms/Suitability-roster.xls


 


11.  Employee Separation Checklist


 


Employee Separation Checklist, 1 page.  Fillable PDF format located at:  


http://rcb.cancer.gov/rcb-internet/forms/Emp-sep-checklist.pdf


 


58

















 


PART IV
- REPRESENTATIONS AND INSTRUCTIONS


 


SECTION K -
REPRESENTATIONS AND CERTIFICATIONS


 


The following documents are incorporated by
reference in this contract:


 


1.               Annual
Representations and Certifications completed and located at the Online
Representations and Certifications Application (ORCA) website.  This includes the changes identified in
paragraph (b) of the FAR provision 52.204-8, Annual Representations and
Certifications, contained in the Contractor’s proposal.


 


2.               Representations
and Certifications, dated August 26, 2008.


 


3.               Human Subjects
Assurance Identification Number FWA00010447.


 


4.               Animal Welfare
Assurance Number A3034-01.


 


END of the SCHEDULE


 


(CONTRACT)


 


59
















 


STATEMENT OF WORK


 


“Biodefense Vaccine
Enhancement - Development of a Third

Generation rPA Anthrax Vaccine”


 


BACKGROUND


 


Research supported and conducted by the
National Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), Department of Health and Human Services, strives to
understand, treat and ultimately prevent the myriad infectious, immunologic,
and allergic diseases that threaten millions of human lives.  The NIAID Division of Microbiology and
Infectious Diseases (DMID) supports extramural research to control and prevent
diseases caused by virtually all infectious agents, with the exception of the
human immunodeficiency virus (HIV).  This
includes basic and applied research to develop and evaluate therapeutics, vaccines,
and diagnostics, which are funded through a variety of research grants and
contracts.  The NIAID is also the primary
institute at the NIH for emerging infectious disease research, including
research on pathogens that can be used as agents of bioterrorism.  Bioterrorism is defined as the use of
microorganisms or the toxins produced by microorganisms to harm people or to
elicit widespread fear and intimidation of society.  Recent events have significantly changed the
world’s perception of the nature and degree of the threats posed by the use of
infectious agents as weapons of bioterrorism. 
The risk of using such weapons once appeared to be restricted to
military encounters.  However, in October of
2001, the exposure of postal workers, other government employees, and U.S.
civilians at large to Bacillus anthracis
spores highlighted the need to devise safe and effective measures to protect
all U.S. citizens from the debilitating and lethal effects of agents of
bioterrorism.  The NIAID supports a
number of basic and applied research efforts to develop countermeasures for
microbes identified by the NIAID biodefense research agenda as Category A, B
and C Priority Pathogens http://www.niaid.nih.gov/Biodefense/bandc_priority.htm.


 


On December 19, 2006, President George W.
Bush signed into law the Pandemic and All-Hazards Preparedness Act (Public Law
109-417), referred to as PAHPA.  Title IV
of PAHPA established the Biomedical Advanced Research and Development Authority
(BARDA) in the Office of the Assistant Secretary for Preparedness and Response
(ASPR) in the U.S. Department of Health and Human Services (HHS) to facilitate
the research, development, and acquisition of medical countermeasures for
chemical, biological, radiological, and nuclear (CBRN) agents and emerging
infectious diseases, including pandemic influenza, that threaten the U.S.
civilian population.  One of the central
responsibilities of BARDA is to lead the HHS Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE), which provides an integrated approach to
the development and purchase of medical countermeasures for public health
medical emergencies.  The HHS PHEMCE
consists of NIH, ASPR, the U.S. Food and Drug Administration (FDA), and Centers
for Disease Control and Prevention (CDC), along with ex officio participation
from other federal agencies.  To guide
progress toward the goal of public health preparedness, the HHS PHEMCE
Implementation Plan provides insight into the current priorities for medical
countermeasure development.


 


BARDA, in partnership with the NIAID on this
contract, is working through advanced product development activities supported
under this contract that will contribute towards allowing candidate medical
countermeasures to progress through the development pipeline toward
licensure.  The eventual goal is to
enable the U.S. Government to stockpile these medical countermeasures to
protect the American public.  Product


 


	
  HHSN272200800049C

  	
   

  	
  Attachment 1

  
	
  Statement of Work

  	
   

  	
   

  
	
  September
  25, 2008

  	
   

  	
   

  



 


1

















 


developers should be cognizant of the
logistical implications of using these products during a public health
emergency.


 


For additional information on BARDA, the PHEMCE
Implementation Plan, and Project BioShield, please visit http://www.hhs.gov/aspr/barda.


 


SCOPE


 


The objective of this contract is to develop an
anthrax vaccine containing rPA and CpG immunostimulant.  The scope of work includes demonstrating
stability of the candidate vaccine and diluent at 35 degrees C over the duration
of the base period; safety prior to human use through acute dose and repeat
dose toxicology testing in 2 animal species; improved vaccine efficacy over
existing vaccines through non-clinical aerosol challenge studies in the
pre-existing rabbit and macaque models, plus supporting studies in the mouse
models.  Options exist for a Phase I and
Phase II clinical trial.


 


TECHNICAL REQUIREMENTS
BY MILESTONE


 


Independently, and not as an agent of the
Government, the Contractor shall furnish all necessary services, qualified
professional, technical, and administrative personnel, material, equipment and
facilities, not otherwise provided by the Government under the terms of the
contract, as needed to perform the Statement of Work.


 


The U.S. Government reserves the right to
determine, at any time during the contract period, that a particular
candidate/product has not demonstrated sufficient potential to merit further
investment in the development and evaluation of that candidate/product.  In addition, the U.S. Government reserves the
right to modify the milestones, progress, schedule, budget, or product to add
or delete products, process, or schedule as need may arise.  Because of the nature of this Research and
Development (R&D) contract and complexities inherent in this and prior
programs, at designated milestones the Government will evaluate whether work
should be redirected, removed, or whether schedule or budget adjustments should
be made.  In any event, the Government reserves
the right to change product, process, schedule, or event to add or delete part
or all of these elements as the needs arise.


 


The Contractor shall attend the following
contract meetings:


 


·                  Post-Award
Contract Initiation Meeting:  Within
thirty (30) calendar days after the effective date of the contract, the
Contractor shall plan, conduct and be responsible for the logistical
arrangements for a 1.5-day Post-award Contract Initiation Meeting to be held in
the Bethesda, Maryland area.


 


·                  Annual Review
Meetings:  The Contractor, in
consultation with the Project Officer, shall plan, organize and conduct 2-day
Annual Review Meetings to be held at the twelve (12) month mark of each
contract year at locations that will alternate between the Contractor’s site
and the Bethesda, Maryland area.  These
meetings shall include updates of the status of efforts for each milestone
since the prior meeting, a description of any problem(s) that may have
arisen and actions taken or recommended to resolve identified problems, and a
discussion of future plans for each milestone.


 


2

















 


·                  Additional
Contract Meetings:  Principal Investigator,
Project Manager, and Contractor and subcontractor personnel shall attend at
least two additional 1-day meetings per year at locations that will alternate
between the Contractor’s site and the Bethesda, Maryland area at the request of
the Project Officer, as necessary, to discuss contract specific issues and to
review recommended changes or deviations from milestones and timelines in the
approved Product Development Plan.


 


BASE PERIOD - Process
Development and Feasibility


 


1.0       Manufacture of cGMP FDP (lyo-rPA/CpG) and diluent (Milestone 1)


 


Within 28 months, complete the release of
>2,000 doses of both cGMP FDP (lyo rPA/CpG) and diluent, suitable for use in
Phase I clinical trials.  Work shall
include the following activities and deliverables:


 


a.               Process
Development


 


·                  Generation of
R&D FDP (lyo rPA/CpG) and diluent for analytical development and
preliminary stability studies


·                  Production of
development lots


·                  Production of
initial reference standard


·                  Development of
the process steps to produce the bulk FDP (lyo rPA/CpG)


·                  Formulation and
its subsequent aliquoting into vials prior to lyophilization.


·                  Development of
the Iyophilization cycle suitable for manufacturing to the required scale.


·                  A final report
shall be provided to the Project Officer, which shall describe the development
activities undertaken, data generated and recommendations for technical
transfer and scale up of the process.


 


b.              Technical
Transfer of process to FDP (lyo rPA/CpG) manufacturer


 


·                  Review audit
status, quality agreement and commercial contract.  Re-audit, update the quality agreement and
contract as required.


·                  Submit copy of
current audit report and quality agreement to the Project Officer for consent
prior to placing orders with CMO.


·                  Transfer of the
lyophilization process to the cGMP facility - CMO.


·                  Establishment
and qualification of the required analytical methods at CMO and/or other
selected CROs.


·                  Technical
transfer reports summarizing completion of activities shall be submitted to the
Project Officer, including analytical qualification reports, prior to GMP
manufacture.


 


c.               Production of
Master Batch Records (MBRs)


 


·                  Master batch
records shall be produced by CMO and reviewed and approved by the Contractor’s
technical and quality functions and by CMO


·                  Final approved
MBRs shall be submitted to the Project Officer prior to production of the
demonstration batches


 


d.              Production of
two demonstration batches of FDP (lyo rPA/CpG)


 


·                  Conduct cGMP
manufacturing runs


·                  Complete release
testing of material


·                  Complete QA
review of batch records, including review of non-conformances and disposition
of batch


 


3

















 


e.               Update of
Master Batch Records (MBRs)


 


·                  Updated Master
batch records shall be produced by CMO and reviewed and approved by the
Contractor’s technical and quality functions and by CMO


 


f.                 Production of
two clinical batches of cGMP FDP (lyo rPA/CpG)


 


·                  Conduct two
cGMP manufacturing runs


·                  Complete
release testing of materials


·                  Complete QA
review of batch records, including review of non-conformances and disposition
of batch


·                  Submit copies
of the executed BMRs and CoA to Project Officer, within 5 months after
manufacture.


 


g.              Clinical batch
of cGMP diluent (to be supplied from the Challenge Grant program)


 


·                  Conduct a cGMP
manufacturing run


·                  Complete
release testing of diluent


·                  Complete QA
review of batch records, including review of non-conformances and disposition
of batch


·                  This work shall
be supplied from the existing challenge grant


 


2.0       Development and Qualification of Assays (Milestone 2)


 


Develop
and qualify all assays required for manufacture, stability, non-clinical and
clinical.  Work shall include the
following activities and deliverables:


 


a.               Analytical
Development and qualification of Process Assays


 


·                  Development and
qualification of in-process monitoring and control assays


·                  Qualification
reports shall be produced and submitted to the Project Officer within 14 months
of award.


 


b.              Analytical
Development and qualification of Product Assays


 


·                  Development and
qualification of product characterization and release assays


·                  Qualification
reports shall be produced and submitted to the Project Officer within 14 months
of award.


 


c.               Analytical
Development and qualification of Stability Indicating Assays


 


·                  Development and
qualification of stability indicating assays


·                  Qualification
reports shall be produced and submitted to the Project Officer within 14 months
of award.


 


d.              Development of
immuno-potency assay in association with on-going rPA vaccine programme.


 


·                  Development of
immuno-potency assay


·                  Development
reports shall be produced and submitted to the Project Officer within 24 months
of award.


 


4

















 


3.0       Stability (Milestone 3)


 


Initiate
R&D and cGMP stability trials within 11 months and 26 months respectively
of contract award.  Work shall include
the following activities and deliverables:


 


a)              Set up R&D
and cGMP stability trials


 


R&D Stability Trials


 


·                  Produce R&D
protocol(s) for FDP (Iyo-rPA/CpG) and diluent stability trials


·                  Initiate the
R&D stability trial using the non-GMP FDP (lyo rPA/CpG) and diluent
material


 


cGMP Stability Trials


 


·                  Review audit
status, quality agreement and commercial contract.  Re-audit, update the quality agreement and
contract as required.


·                  Submit copy of
current audit report and quality agreement to Project Officer prior to placing
orders with CRO


·                  Produce cGMP
protocol(s) for FDP (lyo rPA/CpG) and diluent stability trials


·                  Technical and
quality review and approval of protocols


·                  Initiate
stability trial using the cGMP FDP (lyo rPA/CpG) lot and diluent.  The stability program shall include real-time
and accelerated studies using temperatures of 35 ° C (proposal required
temperature) and 55 ° C (accelerated condition).


·                  cGMP stability
protocols shall be submitted to the Project Officer at least 1 month prior to
initiation of the study.


·                  Updated
stability data shall be submitted to the Project Officer as part of the Monthly
report.


·                  An end of
stability study report shall be submitted to the Project Officer


 


4.0       Pre-Clinical Toxicology (Milestone 4)


 


Within
12 months of contract award, commence a Good Laboratory Practice (GLP) safety
and toxicity study(ies).  Work shall
include the following activities and deliverables:


 


a.               Confirmation of
CRO and Generation of study protocols


 


·                  Review audit
status, quality agreement and commercial contract.  Re-audit, update the quality agreement and
contract as required.


·                  Production of a
draft safety and toxicity protocol(s)


·                  Submit for
Project Officer review a draft safety and toxicity protocol(s) (WBS 4.1.2)


·                  Submit copy of
current audit report and quality agreement to Project Officer prior to placing
orders with CRO.


 


b.              Conduct Acute
Dose Safety and Toxicity Studies


 


·                  Finalize set-up
with CRO (including supply of materials and animals)


·                  Complete acute
dose toxicity studies


·                  Technical and
quality review and approval of reports


·                  Submit reports
to Project Officer.


 


5

















 


c.               Conduct Repeat
Dose Safety and Toxicity Studies


 


·                  Finalize set-up
with CRO (including supply of materials and animals)


·                  Complete repeat
dose toxicity studies


·                  Technical and
quality review and approval of reports


·                  Submit reports
to Project Officer.


 


d.              Conduct Safety
Pharmacology study


 


·                  Finalize set-up
with CRO (including supply of materials and animals)


·                  Complete safety
pharmacology study


·                  Technical and
quality review of report


·                  Submit report
to Project Officer.


 


e.               Submission of
final reports to CBER


 


·                  Submit Acute
Dose report to CBER and seek concurrence


·                  Submit Repeat
Dose report to CBER and seek concurrence


·                  Submit Safety
Pharmacology report to CBER and seek concurrence


·                  Provide
documentation to the Project Officer of interactions with the FDA and that
concurrence has been received from CBER/FDA.


 


5.0       Non-Clinical Development Mouse Model - (Milestone 5)


 


Within
8 month of contract award, commence studies in the mouse model.  Prior to the initiation of these studies,
confirmation of the CRO shall be undertaken.


 


Upon
CRO confirmation the following studies shall be undertaken;


 


i.                  Excipient
Effects


ii.               Immunogenicity
studies


iii.            Dose Ranging
(CpG/rPA ratios)


iv.           Adjuvant
Requirements


 


Each
of the above studies shall include the following activities and deliverables:


 


a.               Animal Studies
Group (ASG) Consultation


 


·                  Submission of a
draft protocol(s) to ASG and NIH


·                  Finalize
protocol incorporating any comments from ASG


·                  Provide
documentation to the Project Officer in the form of written minutes of
interactions with the ASG and that concurrence has been received from ASG.


 


b.              Conduct Studies
(i to iv) and Reporting


 


·                  Finalize set-up
with CRO (including supply of materials and animals)


·                  Complete
studies


·                  Technical and
quality review and approval of report(s)


·                  Submit report(s) to
Project Officer


·                  Circulate
report(s) to ASG


 


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


 


Format:  Payment requests shall be submitted on the
Contractor’s self-generated form in the manner and format prescribed herein and
as illustrated in the Sample Invoice/Financing Request.  Standard Form 1034, Public Voucher for
Purchases and Services Other Than Personal, may be used in lieu of the
Contractor’s self-generated form provided it contains all of the information
shown on the Sample Invoice/Financing Request. 
DO NOT include a cover letter with the payment request.


 


Number of Copies:  Payment requests shall be submitted in the
quantity specified in the Invoice Submission Instructions in Section G of
the Contract Schedule.


 


Frequency:  Payment requests shall not be submitted more
frequently than once every two weeks in accordance with the Allowable Cost and
Payment Clause incorporated into this contract. 
Small business concerns may submit invoices/financing requests more
frequently than every two weeks when 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 Contractor shall site the amount(s) and month(s) in which it
incurred such costs.


 


Contractor’s Fiscal Year:  Payment requests shall be prepared in such a
manner that the Government can identify costs claimed with the Contractor’s
fiscal year.


 


Currency:  All NIH contracts are expressed in United
States dollars.  When the Government pays
in a currency other than United States dollars, billings shall be expressed,
and payment by the 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 identified and reference the Contracting Officer’s Authorization (COA)
Number.  In addition, the Contractor
shall show any cost set forth in an Advance Understanding as a separate line
item on the payment request.


 


Invoice/Financing Request
Identification:  Each
payment 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 shall be submitted promptly upon completion of the work, but
no later than one year from the contract completion date, or within 120 days
after settlement of the final indirect cost rates covering the year in which
the contract is physically complete (whichever date is later).  The Contractor shall submit the completion
invoice when all costs have been assigned to the contract and it completes all
performance provisions.


 


(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 instructions
below.  The instructions are keyed to the
entries on the Sample Invoice/Financing Request.  All information must be legible or the invoice will be
considered improper and returned to the Contractor.


 


(a)          Designated Billing Office Name and Address:  Enter the designated billing office name and
address, as identified in the Invoice Submission Instructions in Section G
of the Contract Schedule.


 


(b)          Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4
Number.  Show the Contractor’s name and
address exactly as they appear in the contract, along with the name, title,
phone number, and e-mail address of the person to notify in the event of an
improper invoice or, in the case of payment by method other than Electronic
Funds Transfer, to whom payment is to be sent. 
If the remittance name differs from the legal business name, both names
must appear on the invoice.  Provide the
Contractor’s Federal Taxpayer Identification Number (TIN) and Data Universal
Numbering System (DUNS) or DUNS+4 number. 
The DUNS number must


 


	
  NIH(RC)-4

  	
   

  	
  ATTACHMENT 2

  
	
  Rev.
  08/2008

  	
   

  	
   

  



 


1

















 


identify the Contractor’s name and address
exactly as stated in the contract, and as registered in the Central Contractor
Registration (CCR) database.  If the
Contractor does not have a valid TIN or DUNS number, provide the Contractor’s
Vendor Identification Number (VIN), which appears after the Contractor’s name
on the face page of the award document. 
[Note:  A VIN is assigned to new contracts awarded on
or after June 4, 2007, and any existing contract modified to include the
VIN number.]  When an
approved assignment of claims has been executed, the Contractor shall provide
the same information for the assignee as is required for the Contractor (i.e.,
name, address, point of contact, TIN, and DUNS number), with the remittance
information clearly identified as such.


 


(c)          Invoice/Financing Request Number: 
Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders
held by an organization.  For example, if
a contractor has already submitted invoice number 05 on one of its contracts or
orders, it cannot use that same invoice number on any other contract or
order.  Payment requests with duplicate
invoice numbers will be considered improper and will be returned to the
contractor.


 


The NIH does not prescribe a particular
numbering format but suggests using a job or account number for each contract
and order followed by a sequential invoice number (example:  8675309-05). 
Invoice numbers are limited to 30 characters.  There are no restrictions on the use of
special characters, such as colons, dashes, forward slashes, or parentheses.


 


If all or part of an invoice is suspended and
the contractor chooses to reclaim those costs on a supplemental invoice, the
contractor may use the same unique invoice number followed by an alpha
character, such as “R” for revised (example: 
8675309-05R).


 


(d)          Date Invoice/Financing Request Prepared: 
Insert the date the payment request is prepared.


 


(e)          Contract Number and Order Number (if applicable):  Insert the contract number and order number
(if applicable).


 


(f)            Effective Date:  Insert
the effective date of the contract or if billing under an order, the effective
date of the order.


 


(g)         Total Estimated Cost of Contract/Order: 
Insert the total estimated cost of the contract, exclusive of
fixed-fee.  If billing under an order,
insert the total estimated cost of the order, exclusive of fixed-fee.  For incrementally funded contracts/orders,
enter the amount currently obligated and available for payment.


 


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


 


(i)            Two-Way/Three-Way Match: 
Identify whether payment is to be made using a two-way or three-way
match.  To determine required payment
method, refer to the Invoice Submission Instructions in Section G of the
Contract Schedule


 


(j)            Office of Acquisitions:  Insert
the name of the Office of Acquisitions, as identified in the Invoice Submission
Instructions in Section G of the Contract Schedule.


 


(k)        Central Point of Distribution: 
Insert the Central Point of Distribution, as identified in the Invoice
Submission Instructions in Section G of the Contract Schedule.


 


(I)            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.


 


(m)      Amount Billed - Current Period: 
Insert the amount claimed for the current billing period by major cost
element, including any adjustments and fixed-fee.  If the Contract Schedule contains separately
priced line items, identify the contract line item(s) on the payment
request and include a separate breakdown (by major cost element) for each line
item.


 


(n)         Amount Billed - Cumulative: 
Insert the cumulative amounts claimed by major cost element, including
any adjustments and fixed-fee.  If the
Contract Schedule contains separately priced line items, identify the contract
line item(s) on the payment request and include a separate breakdown (by
major cost element) for each line item.


 


(o)          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.


 


2

















 


1)              Direct Labor:  Include salaries and wages
paid (or accrued) for direct performance of the contract.


 


For Level of Effort contracts only, the
Contractor shall provide the following information on a separate sheet of paper
attached to the payment request:


 


·                  hours or
percentage of effort and cost by labor category (as specified in the Level of
Effort Article in Section F of the contract) for the current billing
period, and


 


·                  hours or
percentage of effort and cost by labor category from contract inception through
the current billing period.  (NOTE:  The Contracting Officer may require the
Contractor to provide additional breakdown for direct labor, such as position
title, employee name, and salary or hourly rate.)


 


2)              Fringe Benefits:  List
any fringe benefits applicable to direct labor and billed as a direct
cost.  Cite the rate(s) used to
calculate fringe benefit costs, if applicable.


 


3)              Accountable Personal Property: 
Include permanent research equipment and general purpose equipment
having a unit acquisition cost of $1,000 or more, with a life expectancy of
more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property).  Show permanent research equipment separate
from general purpose equipment.


 


On a separate sheet of paper attached to the
payment request, list each item for which reimbursement is requested.  An asterisk (*) shall precede the item if the
equipment is below the $1,000 approval level. 
Include reference to the following (as applicable):


 


·                  item number for
the specific piece of equipment listed in the Property Schedule, and


·                  COA number, if
the equipment is not covered by the Property Schedule.


 


The Contracting Officer may require the
Contractor to provide further itemization of property having specific
limitations set forth in the contract.


 


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 or COA, as well as
the effort (i.e., number of hours, days, etc.) and rate 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.


 


(p)          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.


 


(q)          Indirect Costs: 
Identify the indirect cost base (IDC), indirect cost rate, and amount
billed for each indirect cost category.


 


(r)          Fixed-Fee:  Cite the formula or method of
computation for fixed-fee, if applicable. 
The fixed-fee must be claimed as provided for by the contract.


 


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


 


(t)            Adjustments:  Include amounts conceded by
the Contractor, outstanding suspensions, and/or disapprovals subject to appeal


 


(u)         Grand Totals


 


3

















 


(v)           Certification of Salary Rate Limitation: 
If required by the contract (see Invoice Submission Instructions in Section G
of the Contract Schedule), the Contractor shall include the following
certification at the bottom of the payment request:


 


“I hereby certify that the salaries billed in
this payment request are in compliance with the Salary Rate Limitation
Provisions in Section H of the contract.”


 


The Contracting Officer may
require the Contractor to submit detailed support for costs claimed on one or
more interim payment requests.


 


4

















 


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 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 - Amount Billed -
Current:  Enter amounts billed during
the current period.


 


Column E - Amount Billed -
Cumulative:  Enter the cumulative amounts
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 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.


 


5

















 


SAMPLE INVOICE/FINANCING
REQUEST AND CONTRACT FINANCIAL REPORT


 


(a)          Designated
Billing Office Name and Address:


 


National Institutes of
Health


Office of Financial
Management


Commercial Accounts


2115 East Jefferson
Street, Room 4B432, MSC 8500


Bethesda, MD
20892-8500


 


(b)         Contractor’s
Name, Address, Point of Contact, TIN, and


DUNS or DUNS+4 Number.


 


ABC CORPORATION


100 Main Street


Anywhere, U.S.A. Zip+4


 


Name, Title, Phone Number, and E-mail Address
of person to notify in the event of an improper invoice or, in the case of
payment by method other than Electronic Funds Transfer, to whom payment is to
be sent.


 


*DUNS or DUNS+4:
                                                            

*TIN:


 






*Provide VIN only if Contractor does not
have a valid TIN or DUNS number.


 


(c)          Invoice/Financing
Request No.:


 


(d)         Date Invoice
Prepared:


 


(e)          Contract No. and
Order No. (if applicable):
                          




(f)            Effective Date:


 


(g)         Total Estimated
Cost of Contract/Order.


 


(h)         Total Fixed Fee
(if applicable):


 


(i)             Two-Way
Match: 
        

Three-Way Match:


 


J)               Office of
Acquisitions:




 


(k)          Central Point
of Distribution:


 


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


 


	
   

  	
   

  	
  Cumulative

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Percentage

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  of Effort/Hrs

  	
   

  	
  Amount Billed

  	
   

  	
  Cost at

  	
   

  	
  Contract

  	
   

  	
   

  	
   

  
	
  Expenditure
  Category*

  A

  	
   

  	
  Negotiated

  B

  	
   

  	
  Actual 

  C

  	
   

  	
  (m) Current

  D

  	
   

  	
  (n) Cumulative

  E

  	
   

  	
  Completion

  F

  	
   

  	
  Value

  G

  	
   

  	
  Variance 

  H

  	
   

  
	
  (o)   Direct
  Costs:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (1)   Direct
  Labor

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (2)   Fringe
  Benefits    %

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (3)   Accountable
  Property

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (4)   Materials &
  Supplies

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (5)   Premium
  Pay

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (6)   Consultant
  Fees

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (7)   Travel

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (8)   Subcontracts

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
         (9)   Other

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (p)   Cost of
  Money    %

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (q)   Indirect
  Costs    %

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (r)   Fixed
  Fee    %

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (s)   Total
  Amount Claimed

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (t)   Adjustments

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (u)  Grand Totals

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
																			



 


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


 


	
   

  	
   

  	
   

  	
   

  
	
   

  	
  (Name of

  	
   

  	
            (Title)

  



 






*Attach details as specified in the
contract or requested by the Contracting Officer


 


6
















 


INCLUSION
ENROLLMENT REPORT


 


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


 


	
  Study Title:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Total Enrollment:

  	
   

  	
  Protocol Number:

  
	
  Contract Number:

  	
   

  	
   

  



 


	
  PART A. TOTAL
  ENROLLMENT REPORT:

  	
   

  	
  Number of Subjects Enrolled
  to Date (Cumulative) by Ethnicity and Race

  



 


	
   

  	
   

  	
  Sex/Gender

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ethnic Category

  	
   

  	
  Females

  	
   

  	
  Males

  	
   

  	
  Unknown or Not Reported

  	
   

  	
  Total

  	
   

  
	
  Hispanic or Latino

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Not Hispanic or Latino

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Unknown (Individuals not reporting
  ethnicity)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Ethnic Category: Total of All
  Subjects*

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  0

  	
   

  
	
  Racial Categories

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  American Indian/Alaska Native

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Asian

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Native Hawaiian or Other Pacific
  Islander

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Black or African American

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  White

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  More than one race

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Unknown or not reported

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Racial Categories: Total of All
  Subjects*

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  0

  	
   

  



 


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

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Asian

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Native Hawaiian or Other Pacific
  Islander

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Black or African American

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  White

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  More Than One Race

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Unknown or not reported

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  0

  	
   

  
	
  Racial Categories: Total
  of Hispanics or Latinos**

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  0

  	
   

  	
  0

  	
   

  



 






*These totals must agree


**These totals must agree


 


	
  Inclusion Enrollment Report

  	
   

  	
   

  
	
  October,
  2001

  	
   

  	
  ATTACHMENT 3

  



 

















 


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

  	
   

  	
   

  
	
  July 1994

  	
   

  	
  ATTACHMENT 4

  



 

















 


HHSAR 352.223-70
SAFETY AND HEALTH (JANUARY 2006)


 


(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).


 


1.               In addition, the following regulations must be followed when developing
and implementing health and safety operating procedures and practices for both
personnel and facilities involving the use or handling of hazardous materials
and the conduct of research, development, or test projects:


 


(1)          29 CFR 1910.1030, Bloodborne pathogens; 29 CFR 1910.1450, Occupational
exposure to hazardous chemicals in laboratories; and other applicable
occupational health and safety standards issued by the Occupational Health and
Safety Administration (OSHA) and included in 29 CFR Part 1910.  These regulations are available at:  http://www.osha.gov/comp-links.html


 


(2)          Nuclear Regulatory Commission Standards and Regulations, pursuant to
the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.).  Copies may be obtained from the U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001.


 


2.               The following guidelines are recommended for use in developing and
implementing health and safety operating procedures and practices for both
personnel and facilities:


 


(1)          Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH,
HHS.  This publication is available at http://bmbl.od.nih.gov/index.htm.


 


(2)          Prudent Practices for Safety in Laboratories (1995), National Research
Council, National Academy Press, 500 Fifth Street, NW., Lockbox 285,
Washington, DC 20055 (ISBN 0-309-05229-7). 
This publication can be obtained by telephoning 800-624-8373.  It also is available at http://www.nap.edu/cataloq/4911.html.


 


(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 officers, 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 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 hazardous
operations.  Compliance with the provisions
of this clause by subcontractors will be the responsibility of the Contractor.


 


(End of Clause)


 


	
  Safety and Health

  	
   

  	
   

  
	
  HHSAR 352.223-70 (1/06)

  	
   

  	
  ATTACHMENT 5

  



 

















 


PROCUREMENT OF CERTAIN EQUIPMENT,
NIH(RC)-7


 


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 cost-reimbursement 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)

  	
   

  	
   

  
	
  OMB Bulletin 81-16

  	
   

  	
  ATTACHMENT 6

  



 

















 


RESEARCH
PATIENT CARE COSTS — NIH(RC)-11


 


(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.


 


	
  NIC(RC)-4 (4/1/84)

  	
   

  	
  ATTACHMENT 7

  



 

















 


	
  DISCLOSURE OF LOBBYING ACTIVITIES

  	
  Approved by OMB

  
	
  Complete this form to disclose lobbying
  activities pursuant to 31 U.S.C. 1352 

  (See reverse for public burden disclosure.)

  	
  0348-0046

  
	
   

  	
   

  
	
  1.  Type of Federal Action:

  	
  2.  Status of Federal Action:

  	
  3.  Report Type:

  
				



 


	
  o

  	
  a.  contract

  b.  grant

  c.  cooperative agreement

  d. 
  loan

  e. 
  loan guarantee

  f. 
  loan insurance

  	
   

  	
  o

  	
  a. 
  bid/offer/application

  b. 
  initial award

  c. 
  post-award

  	
   

  	
  o

  	
  a. 
  initial filing

  b. 
  material change

  
	
   

  	
  For Material Change Only:

  Year
                
  quarter
                

  date of last report 
                      

  
	
   

  	
   

  	
   

  	
   

  
	
  4.

  	
  Name and Address of
  Reporting Entity:

  	
  5.

  	
  If Reporting Entity in No. 4
  is a Subawardee, Enter Name and 

  
	
   

  	
  o Prime

  	
  o Subawardee

  	
   

  	
  Address of Prime:

  
	
   

  	
   

  	
  Tier
                  ,
  if known:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Congressional District, if known:  4c

  	
   

  	
  Congressional District, if known:

  
	
   

  	
   

  	
   

  
	
  6.  Federal Department/Agency:

  	
  7.  

  	
  Federal Program Name/Description:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CFDA Number,
  if applicable:
                            

  
	
   

  	
   

  	
   

  
	
  8.  Federal Action Number, if known :

  	
  9.

  	
  Award Amount, if known :

  
	
   

  	
   

  	
  $

  
	
   

  	
   

  	
   

  
	
  10. a.

  	
  Name and Address of Lobbying
  Registrant

  	
  b.

  	
  Individuals Performing
  Services

  
	
   

  	
  (if
  individual, last name, first name, MI):

  	
   

  	
  (including
  address if different from No. 10a)

  
	
   

  	
   

  	
   

  	
  (last
  name, first name, MI):

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  11.

  	
  Information requested through this form
  is authorized 

  	
   

  
	
   

  	
  by title 31 U.S.C. section 1352.  This disclosure of

  	
   

  
	
   

  	
  lobbying activities is a material
  representation of fact

  	
   

  
	
   

  	
  upon which reliance was placed by the
  tier above

  	
   

  
	
   

  	
  when this transaction was made or
  entered into.  This

  	
   

  
	
   

  	
  disclosure is required pursuant to 31
  U.S.C. 1352.  

  	
   

  
	
   

  	
  This information will be available for
  public

  	
   

  
	
   

  	
  inspection.  Any person who fails to file the required

  	
   Signature:

  	
   

  
	
   

  	
  disclosure shall be subject to a civil
  penalty of not less

  	
   Print Name:

  	
   

  
	
   

  	
  than $10,000 and not more than $100,000
  for each 

  	
   Title:

  	
   

  
	
   

  	
  such failure.

  	
   Telephone No.:

  	
   

  	
   

  	
  Date:

  	
   

  
	
   

  	
   

  	
   

  
	
  Federal Use Only:

  	
   

  	
  Authorized for Local Reproduction

  
	
   

  	
   

  	
  Standard Form LLL (Rev. 7-97)

  
																							



 


	
  Disclosure of Lobbying Activities, SF-LLL

  	
   

  	
   

  
	
  7/97

  	
   

  	
  ATTACHMENT 8

  



 

















 


INSTRUCTIONS FOR
COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES


 


This disclosure form shall be completed by the
reporting entity, whether subawardee or prime Federal recipient, at the
initiation or receipt of a covered Federal action, or a material change to a
previous filing, pursuant to title 31 U.S.C. section 1352.  The filing of a form is required for each
payment or agreement to make payment to any lobbying entity for influencing or
attempting to influence an officer or employee of any agency, a Member of
Congress, an officer or employee of Congress, or an employee of a Member of
Congress in connection with a covered Federal action.  Complete all items that apply for both the
initial filing and material change report. 
Refer to the implementing guidance published by the Office of Management
and Budget for additional information.


 


1.               Identify the type of covered Federal action for which lobbying activity
is and/or has been secured to influence the outcome of a covered Federal
action.


 


2.               Identify the status of the covered Federal action.


 


3.               Identify the appropriate classification of this report.  If this is a followup report caused by a
material change to the information previously reported, enter the year and
quarter in which the change occurred. 
Enter the date of the last previously submitted report by this reporting
entity for this covered Federal action.


 


4.               Enter the full name, address, city, State and zip code of the reporting
entity.  Include Congressional District,
if known.  Check the appropriate
classification of the reporting entity that designates if it is, or expects to
be, a prime or subaward recipient. 
Identify the tier of the subawardee, e.g., the first subawardee of the
prime is the 1st tier.  Subawards include
but are not limited to subcontracts, subgrants and contract awards under
grants.


 


5.               If the organization filing the report in item 4 checks “Subawardee,”
then enter the full name, address, city, State and zip code of the prime
Federal recipient.  Include Congressional
District, if known.


 


6.               Enter the name of the Federal agency making the award or loan
commitment.  Include at least one
organizational level below agency name, if known.  For example, Department of Transportation,
United States Coast Guard.


 


7.               Enter the Federal program name or description for the covered Federal
action (item 1).  If known, enter the
full Catalog of Federal Domestic Assistance (CFDA) number for grants,
cooperative agreements, loans, and loan commitments.


 


8.               Enter the most appropriate Federal identifying number available for the
Federal action identified in item 1 (e.g., Request for Proposal (RFP) number;
Invitation for Bid (IFB) number; grant announcement number; the contract,
grant, or loan award number; the application/proposal control number assigned
by the Federal agency).  Include
prefixes, e.g., “RFP-DE-90-001.”


 


9.               For a covered Federal action where there has been an award or loan
commitment by the Federal agency, enter the Federal amount of the award/loan
commitment for the prime entity identified in item 4 or 5.


 


10.         (a) Enter the full name, address, city, State and zip code of the
lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the
reporting entity identified in item 4 to influence the covered Federal action.


 


(b)         Enter the full names of the individual(s) performing services, and
include full address if different from 10 (a). 
Enter Last Name, First Name, and Middle Initial (MI).


 


11.         The certifying official shall sign and date the form, print his/her
name, title, and telephone number.


 


According to the Paperwork Reduction Act, as
amended, no persons are required to respond to a collection of information
unless it displays a valid OMB Control Number. 
The valid OMB control number for this information collection is OMB No. 0348-0046.  Public reporting burden for this collection
of information is estimated to average 10 minutes per response, including time
for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of
information.  Send comments regarding the
burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden, to the Office of Management and
Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503.