Exhibit
10.44


 


	
  AWARD/CONTRACT

  	
  1.    THIS CONTRACT IS A
  RATED ORDER

  UNDER DPAS (15 CFR 350)

  	
  RATING

  N/A

  	
   

  	
  PAGE     OF

  1

  	
  PAGES

  28

  
	
   

  	
   

  	
   

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

  N01-AI-30052

  	
  3.   EFFECTIVE
  DATE

  September 30, 2003

  	
  4.   REQUISITION/PURCHASE
  REQUEST/PROJECT NO.

  VR075

  
	
   

  	
   

  	
   

  
	
  5.   ISSUED BY

  	
  CODE

  	
  2606-30052

  	
  6.   ADMINISTERED BY (If other than Item 5)

  	
  CODE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institute of
  Health

  Contract Management Branch, NIAID

  Room 2230

  8700-B Rockridge Dr. MSC 7612

  Belhasda, Maryland 20892-7612

  	
  DMID-VR

  RFP NIH-NIAID-DMID-03-29

  	
   

  
	
   

  	
   

  	
   

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

  	
  8. DELIVERY

  
	
   

  	
   

  
	
  Avecia Limited

  PO Box 42, Hexagon House

  Blackley

  Manchester M9 6ZS

  England

  	
  o FOB ORIGIN 

  	
  x OTHER (See
  below)

  FOB Destination



  
	
  9. DISCOUNT FOR PROMPT PAYMENT

  
	
  N/A

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  10. SUBMIT INVOICES ADDRESS 

  SHOWN IN

  	
  ITEM

  G.3.

  
	
  CODE

  	
   

  	
  FACILITY CODE

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  11. SHIP TO/MARK FOR

  	
  CODE

  	
  N/A

  	
  12.
  PAYMENT WILL BE MADE BY

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  
	
  Article F.1.

  	
   

  	
   

  	
  See
  Article G.3.

  	
   

  	
   

  
	
   

  	
   

  	
   

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

  	
  14.
  ACCOUNTING AND APPROPRIATION DATA

  
	
   

  	
   

  	
   

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

  Period, September 30, 2003 through October 12, 2006

  Amount Allotted: $29,410,000

  Contact Type: Cost Plus Fixed Fee/Completion

  	
   

  	
   

  	
   

  FY
  03

  FY
  04

  	
   

  $29,410,000

  $41,882,000

  
	
   

  	
   

  	
   

  
	
   

  	
  15Q TOTAL AMOUNT OF CONTRACT

  	
  $71,292,000

  
	
   

  	
   

  	
   

  
	
  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

  	
   

  	
  22

  	
   

  
	
  x

  	
   

  	
  B

  	
   

  	
  SUPPLIES
  OR SERVICES AND PRICES/COST

  	
   

  	
  4

  	
   

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

  	
   

  
	
  x

  	
   

  	
  C

  	
   

  	
  DESCRIPTION/SPECS./WORK
  STATEMENT

  	
   

  	
  10

  	
   

  	
  x

  	
   

  	
  J

  	
   

  	
  LIST
  OF ATTACHMENTS

  	
   

  	
  27

  	
   

  
	
  x

  	
   

  	
  D

  	
   

  	
  PACKAGING
  AND MARKING

  	
   

  	
  11

  	
   

  	
   

  	
   

  	
  PART IV - REPRESENTATIONS
  AND INSTRUCTIONS

  	
   

  
	
  x

  	
   

  	
  E

  	
   

  	
  INSPECTION
  AND ACCEPTANCE

  	
   

  	
  11

  	
   

  	
  x

  	
   

  	
  K

  	
   

  	
  REPRESENTATIONS,
  CERTIFICATIONS AND 

  	
   

  	
   

  	
   

  
	
  x

  	
   

  	
  F

  	
   

  	
  DELIVERIES
  OR PERFORMANCE

  	
   

  	
  12

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  OTHER
  STATEMENTS OF OFFERORS

  	
   

  	
  28

  	
   

  
	
  x

  	
   

  	
  G

  	
   

  	
  CONTRACT
  ADMINISTRATION DATA

  	
   

  	
  13

  	
   

  	
  o

  	
   

  	
  L

  	
   

  	
  INSTRS.,
  CONDS., AND NOTICES TO OFFERORS

  	
   

  	
   

  	
   

  
	
  x

  	
   

  	
  H

  	
   

  	
  SPECIAL
  CONTRACT REQUIREMENTS

  	
   

  	
  16

  	
   

  	
  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 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 condition 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)

   

  David Greensmith

  Chief Operating Officer (COO)

  	
   

  	
  20A. NAME OF CONTRACTING OFFICER

   

  Elizabeth Ozinski

  Contracting Officer, CMB, NIAID, NIH

  
	
   

  	
   

  	
   

  
	
  19B. NAME OF CONTRACTOR

  	
   

  	
   

  	
  20B. UNITED STATES OF AMERICA

  	
   

  
	
   

  	
  19C. DATE SIGNED

  	
   

  	
   

  	
  20C. DATE SIGNED

  
	
  BY

  	
  /s/ David Greensmith

  	
   

  	
  29 SEPTEMBER 2003

  	
   

  	
  BY

  	
  /s/ Elizabeth Ozinski

  	
   

  	
  9/23/03

  
	
   

  	
  (Signature of person
  authorized to sign)

  	
   

  	
   

  	
   

  	
   

  	
  (Signature of Contracting Officer)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NSN 7640-01-152-8089

  PREVIOUS EDITION UNUSABLE

  	
  M-107

  Computer Generated

  	
  STANDARD FORM 26 (Rev. 4-A5)

  Prescribed by GSA

  FAR (48 CFR) 53.214(a)

  
													



 

















 


Contract No. N01-AI-30052


 


DETAILED TABLE OF CONTRACT
CONTENTS


 


	
  PART I - THE SCHEDULE

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION A
  - SOLICITATION/CONTRACT FORM

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION B
  - SUPPLIES OR SERVICES AND PRICES/COSTS

  	
  4

  
	
   

  	
  ARTICLE B.1. BRIEF
  DESCRIPTION OF SUPPLIES OR SERVICES

  	
  4

  
	
   

  	
  ARTICLE B.2. ESTIMATED
  COST AND FIXED FEE

  	
  4

  
	
   

  	
  ARTICLE B.3. PROVISIONS
  APPLICABLE TO DIRECT COSTS

  	
  4

  
	
   

  	
  ARTICLE B.4. ADVANCE
  UNDERSTANDINGS

  	
  5

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION C
  - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

  	
  10

  
	
   

  	
  ARTICLE C.1. STATEMENT OF
  WORK

  	
  10

  
	
   

  	
  ARTICLE C.2. REPORTING
  REQUIREMENTS

  	
  10

  
	
   

  	
  ARTICLE C.3. INVENTION
  REPORTING REQUIREMENT

  	
  11

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION D
  - PACKAGING, MARKING AND SHIPPING

  	
  11

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION E
  - INSPECTION AND ACCEPTANCE

  	
  11

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION F
  - DELIVERIES OR PERFORMANCE

  	
  12

  
	
   

  	
  ARTICLE F.1. DELIVERIES

  	
  12

  
	
   

  	
  ARTICLE F.2. CLAUSES
  INCORPORATED BY REFERENCE

  	
  13

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION G
  - CONTRACT ADMINISTRATION DATA

  	
  13

  
	
   

  	
  ARTICLE G.1. PROJECT
  OFFICER

  	
  13

  
	
   

  	
  ARTICLE G.2. KEY PERSONNEL

  	
  14

  
	
   

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

  	
  14

  
	
   

  	
  ARTICLE G.4. INDIRECT COST
  RATES

  	
  14

  
	
   

  	
  ARTICLE G.5. GOVERNMENT
  PROPERTY

  	
  15

  
	
   

  	
  ARTICLE G.6. POST AWARD
  EVALUATION OF CONTRACTOR PERFORMANCE

  	
  15

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION H
  - SPECIAL CONTRACT REQUIREMENTS

  	
  16

  
	
   

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

  	
  16

  
	
   

  	
  ARTICLE H.2. HUMAN
  SUBJECTS

  	
  16

  
	
   

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

  	
  16

  
	
   

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

  	
  17

  
	
   

  	
  ARTICLE H.5. HUMAN
  MATERIALS

  	
  17

  
	
   

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

  	
  17

  
	
   

  	
  ARTICLE H.7. NEEDLE
  EXCHANGE

  	
  17

  
	
   

  	
  ARTICLE H.8. PRIVACY ACT

  	
  18

  
	
   

  	
  ARTICLE H.9. INTRODUCTION
  OF RODENTS AND RODENT PRODUCTS

  	
  18

  
	
   

  	
  ARTICLE H.10. ANIMAL
  WELFARE

  	
  18

  
	
   

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

  	
  18

  
	
   

  	
  ARTICLE H.12. SALARY RATE
  LIMITATION LEGISLATION PROVISIONS

  	
  18

  
	
   

  	
  ARTICLE H.13. PUBLICATION
  AND PUBLICITY

  	
  19

  
	
   

  	
  ARTICLE H.14. PRESS
  RELEASES

  	
  19

  
	
   

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

  	
  19

  
	
   

  	
  ARTICLE H.16. ANTI
  -LOBBYING

  	
  19

  
	
   

  	
  ARTICLE H.17. OBTAINING
  AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

  	
  20

  
	
   

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

  	
  20

  
	
   

  	
  ARTICLE H.19. OFFICE OF
  HEALTH AND SAFETY - LABORATORY REGISTRATION/SELECT AGENT TRANSFER PROGRAM

  	
  20

  



 


2

















 


Contract
No. N01-AI-30052


 


	
   

  	
  ARTICLE H.20. SELECT AGENT
  AWARDS TO FOREIGN CONTRACTORS STATUS

  	
  20

  
	
   

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

  	
  20

  
	
   

  	
   

  	
   

  
	
  PART II - CONTRACT CLAUSES

  	
  22

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION I
  - CONTRACT CLAUSES

  	
  22

  
	
   

  	
  ARTICLE I.1. GENERAL CLAUSES
  FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT

  	
  22

  
	
   

  	
  ARTICLE I.2. AUTHORIZED
  SUBSTITUTION OF CLAUSES

  	
  24

  
	
   

  	
  ARTICLE I.3. ADDITIONAL
  CONTRACT CLAUSES

  	
  25

  
	
   

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

  	
  26

  
	
   

  	
   

  	
   

  
	
  PART III

  	
  27

  
	
   

  	
   

  	
   

  
	
   

  	
  SECTION J
  - LIST OF ATTACHMENTS

  	
  27

  
	
   

  	
  1.

  	
  Statement
  of Work

  	
  27

  
	
   

  	
  2.

  	
  Invoice/Financing
  Request and Contract Financial Reporting Instructions for NIH
  Cost-Reimbursement Type Contracts

  	
  27

  
	
   

  	
  3.

  	
  Inclusion
  Enrollment Report

  	
  27

  
	
   

  	
  4.

  	
  Annual
  Technical Progress Report Format for Each Study

  	
  27

  
	
   

  	
  5.

  	
  Research
  Patient Care Costs

  	
  27

  
	
   

  	
  6.

  	
  Safety
  and Health

  	
  27

  
	
   

  	
  7.

  	
  Procurement
  of Certain Equipment

  	
  27

  
	
   

  	
   

  	
   

  	
   

  
	
  PART IV

  	
  28

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  SECTION K -
  REPRESENTATIONS AND CERTIFICATIONS

  	
  28

  
	
   

  	
  1.

  	
  Representations
  and Certifications

  	
  28

  
	
   

  	
  2.

  	
  Human
  Subjects Assurance Identification Number

  	
  28

  
	
   

  	
  3.

  	
  Animal
  Welfare Assurance Number

  	
  28

  



 


3
















 


Contract
No. N01-AI-30052


 


SECTION B
- SUPPLIES OR SERVICES AND PRICES/COSTS


 


ARTICLE B.1.  BRIEF DESCRIPTION OF SUPPLIES OR
SERVICES


 


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


 


ARTICLE B.2.  ESTIMATED COST AND FIXED FEE


 


a.             The estimated cost of this contract is
[***].


 


b.             The fixed fee for this contract is
[***].  The fixed fee shall be paid in
installments based on the negotiated milestones set forth in
ARTICLE B.4.h. and subject to the withholding provisions of the clauses
ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause
Listing in Part II, ARTICLE 1.1. of this contract.  Payment of fixed fee shall not be made in
less than monthly increments.


 


c.             The Government’s obligation, represented
by the sum of the estimated cost plus fixed fee, is [***].


 


d.             Total funds currently available for
payment and allotted to this contract are: 
[***], of which [***] represents the estimated costs, and of which [***]
represents the fixed fee.  These funds
cover the start dates for Milestones 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15, 16 and 17.  For further
provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II,
ARTICLE I.2. Authorized Substitutions of Clauses.


 


e.             It is estimated that the amount currently
allotted will cover performance of the contract through September 29,
2004.


 


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


 


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


 


	
  FY

  	
   

  	
  PERIOD

  	
   

  	
  ESTIMATED COST

  	
   

  	
  FIXED FEE

  	
   

  	
  TOTAL AMOUNT

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  04

  	
   

  	
  9/30/04 -
  10/13/06

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


These funds
cover continuation of Milestones 7, 9, 10, 11, 12, 13, and 17.


 


ARTICLE B.3.  PROVISIONS APPLICABLE TO DIRECT COSTS


 


a.             Items Unallowable Unless
Otherwise Provided


 


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


 


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


 


(2)           Special rearrangement
or alteration of facilities;


 


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


 


(4)           Travel to attend
general scientific meetings;


 


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


 


(6)           Consultant costs;


 


4

















 


Contract
No. N01-AI-30052


 


(7)           Subcontracts;


 


(8)           Patient care costs;


 


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


 


b.             Travel Costs


 


(1)           Travel


 


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


 


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


 


ARTICLE B.4.  ADVANCE UNDERSTANDINGS


 


Other
provisions of this contract notwithstanding, approval of the following items
within the limits set forth is hereby granted without further authorization
from the Contracting Officer.


 


a.             Subcontract


 


To negotiate a
firm fixed price type subcontract with Baxter Healthcare Corporation (BHC) for
an amount not to exceed [***].  Award of
the subcontract shall not proceed without the prior written approval of the
Contracting Officer upon review of the supporting documentation and the draft
subcontract as required by the Subcontracts clause of the General Clauses
incorporated in this contract.  After
written approval of the subcontract by the Contracting Officer, a copy of the
signed, approved subcontract shall be provided to the Contracting Officer.


 


b.             Subcontract


 


To negotiate a
firm fixed price type subcontract with Baxter Pharmaceutical Solutions LLC
(BPS) for an amount not to exceed [***]. 
Award of the subcontract shall not proceed without the prior written
approval of the Contracting Officer upon review of the supporting documentation
and the draft subcontract as required by the Subcontracts clause of the General
Clauses incorporated in this contract. 
After written approval of the subcontract by the Contracting Officer, a
copy of the signed, approved subcontract shall be provided to the Contracting
Officer.


 


c.             Subcontract


 


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


 


d.             Subcontract


 


To negotiate a
firm fixed price type subcontract with Parexel International Corporation (PxI)
for an amount not to exceed [***].  Award
of the subcontract shall not proceed without the prior written approval of the
Contracting Officer upon review of the supporting documentation and the draft
subcontract as required by the Subcontracts clause of the General Clauses
incorporated in this contract.  After
written approval of the subcontract by the Contracting Officer, a copy of the
signed, approved subcontract shall be provided to the Contracting Officer.


 


5





















 


Contract
No. N01-AI-30052


 


e.             Subcontract


 


To negotiate a
firm fixed price type subcontract with Inveresk Ltd. for an amount not to
exceed [***].  Award of the subcontract
shall not proceed without the prior written approval of the Contracting Officer
upon review of the supporting documentation and the draft subcontract as
required by the Subcontracts clause of the General Clauses incorporated in this
contract.  After written approval of the
subcontract by the Contracting Officer, a copy of the signed, approved
subcontract shall be provided to the Contracting Officer.


 


f.              Subcontract


 


To negotiate a
firm fixed price type subcontract with SRI International (SRI) for an amount
not to exceed [***].  Award of the
subcontract shall not proceed without the prior written approval of the
Contracting Officer upon review of the supporting documentation as required by
the Subcontracts clause of the General Clauses incorporated in this
contract.  After written approval of the
subcontract by the Contracting Officer, a copy of the signed, approved
subcontract shall be provided to the Contracting Officer.


 


g.             Ceilings


 


(1)           In no event shall the
final amount reimbursable for the Overhead R&D Burn Rate using a base of
Scientific Labor exceed a ceiling of 99% for the entire performance period of
this contract.


 


(2)           In no event shall the
final amount reimbursable for Labor Overhead using a base of Direct Scientific
Labor, plus R&D Burn on scientific labor, plus Direct Project Management
Labor exceed a ceiling of 66% for the entire performance period of this
contract.


 


(3)           In no event shall the
final amount reimbursable for Fringe Benefits exceed a ceiling of 38% for the
entire performance period of this contract.


 


(4)           In no event shall the
final amount reimbursable for ABC 5000 facility daily rate exceed [***].  The contractor must submit to the Financial
Advisory Services Branch, NIH the actual costs, excluding profit, for the ABC
5000 facility as of 12/31/03 and 12/31/04. 
The actual costs will be evaluated and the contractor will be required
to make adjustments to the facility costs that have been reimbursed to the
contractor based on the funded amount.


 


(5)           This is authorization
to charge as a direct cost to the contract a daily cost not to exceed [***] per
day for office leasing space for the first year of the contract in a total
amount not to exceed a ceiling of [***].


 


(6)           The Government is not
obligated to pay any additional amount should the final indirect cost rates
exceed these negotiated ceiling rates. 
In the event that the final indirect cost rates are less than these
negotiated ceiling rates, the Government’s obligation shall be reduced to
conform to the lower rates.  Any costs
over and above this cost ceiling shall not be reimbursed under this contract or
any other Government contract, grant, or cooperative agreement.


 


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


 


h.             Contract Milestones


 


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


 


6

















 


Contract
No. N01-AI-30052


 


	
   

  	
   

  	
  MILESTONES

  	
   

  	
  ESTIMATED

  COST

  	
   

  	
  FIXED FEE

  	
   

  	
  TOTAL

  CPFF

  	
   

  
	
   

  	
   

  	
  Milestones for
  Avecia

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  Submit
  refined preclinical testing plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  Submit
  refined clinical testing plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  Submit
  refined regulatory plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4

  	
   

  	
  Complete
  development and validation of assays on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  Demonstrated
  suitability of facility on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6

  	
   

  	
  Demonstrated
  tech transfer on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  Submit
  inventory storage/maintenance plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8

  	
   

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

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  9

  	
   

  	
  Stockpile
  manufacturing feasibility plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  10

  	
   

  	
  Manufacture
  all bulk rPA on/before [***] and fee will be paid after receipt of
  Certificate of Analysis.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11

  	
   

  	
  Fill/Finish
  3 million doses on/before [***] and fee will be paid after receipt of
  Certificate of Analysis.

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  12

  	
   

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

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13

  	
   

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

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14

  	
   

  	
  Preclinical
  studies completed on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15

  	
   

  	
  Complete
  regulatory plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


7

















 


Contract
No. N01-AI-30052


 


	
   

  	
   

  	
  MILESTONES

  	
   

  	
  ESTIMATED

  COST

  	
   

  	
  FIXED FEE

  	
   

  	
  TOTAL

  CPFF

  	
   

  
	
   

  	
   

  	
  Milestones for
  Avecia

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16

  	
   

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

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  17

  	
   

  	
  Complete
  inventory storage/maintenance plan on/before [***].

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  



 


i.              Scientific
Meetings


 


Travel to
general scientific meetings as follows:


 


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


 


j.              Protocol Approvals


 


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


 


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


 


k.             Subcontractor Estimated
Expenditures


 


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


 


l.              Invoices - Cost and
Personnel Reporting, and Variances from the Negotiated Budget


 


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


 


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


(b)           Fringe Benefits - Cite
rate and amount


(c)           Overhead - Cite rate
and amount


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


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


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


(g)           Equipment - Cite
authorization and amount.


(h)           Total Cost


(i)            Fixed Fee


(j)            Total CPFF


 


8

















 


Contract
No. N01-AI-30052


 


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


 


(2)           The contractor agrees
to immediately notify the contracting officer in writing if there is an
anticipated overrun (any amount) or unexpended balance (greater than 10
percent) of the amount allotted to the contract, and the reasons for the
variance.  Also refer to the requirements
of the Limitation of Funds and Limitation of Cost Clauses in the contract.


 


m.            FAR Clause 52.223-6 Drug Free Workplace is
included in this contract, however, FAR 23.501 (c) provides that the
clause does not apply to work that is “(c) Performed outside of the United
States and its outlying areas or any part of a contract performed outside the
United States and its outlying areas.”


 


n.             Understanding regarding
FAR 52.222-36


 


FAR 22.1408(a) requires
the Contracting Officer to “Insert the clause at 52.222-36, Affirmative Action
for Workers with Disabilities, in solicitations and contracts that exceed or
are expected to exceed $ 10,000, except when - -


 


“(1) Both
performance of the work and the recruitment of workers will occur outside the
United States, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam,
the U.S.  Virgin Islands, and Wake
Island; or


 


“(2) The
agency head has waived, in accordance with 22.1403(a) or 22.1403(b) all
the terms of the clause.”


 


It is the
mutual understanding of the contracting officer and Avecia that a significant
portion of the work, including all self-performed work, under this contract
will be performed outside the United States and the other named territories by
workers recruited from outside the United States and the named
territories.  However, it is also
mutually understood that some subcontracted work will be performed in the
United States.  Therefore both parties
agree that FAR 52.222-36(a) (b) and (c) will not apply to Avecia
and that FAR 52122-36 (d) “Subcontracts” will only apply to subcontracts
that will be performed in the United States or by workers recruited from the
United States and the named territories; i.e., FAR 52.222-36 would apply in its
entirety to any subcontractor that performs work in the United States.  It is also agreed that Avecia will flow-down
language similar to that in this paragraph to its subcontracts not performed in
the United Stales; i.e., FAR 52.222-36 would apply in its entirety to any
second-tier (or lower) subcontracts performed in the United States.


 


o.             Understanding regarding
FAR 52.222-37


 


FAR
22.1310(a)(1)(i) provides that FAR 52.222-35, Equal Opportunity for
Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans, is required to be in contracts over $25,000, except when “Work is
performed outside the United States by employees recruited outside the United
States”.  As FAR 52.222-35(d) contains
an “Applicability” clause that limits its reach to the listing of employment
openings within the United States and named territories, no additional
understanding beyond that applicability clause is necessary.


 


FAR 22.1310(b) provides
that 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of
the Vietnam Era, and Other Eligible Veterans, in solicitations and contracts
containing the clause at 52.222-35, Equal Opportunity for Special Disabled
Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans.  Therefore, if “Work is performed outside the
United States by Employees recruited outside the United States,” FAR 52.222-37
would not be required.


 


It is the
mutual understanding of the contracting officer and Avecia that a significant
portion of the work, including all self-performed work, under this contract
will be performed outside the United States and the other named territories by
workers recruited from outside the United States and the named
territories.  However, it is also
mutually understood that some subcontracted work will be performed in the
United States.  Therefore both parties
agree that FAR 52.222-37(a) through (c) will not apply to Avecia and
that FAR 52.222-37 (f) will only apply to subcontracts that will be
performed in the United States or by workers recruited from the United States;
i.e., FAR 52.222-37 would apply in its entirety to any subcontractor that
performs work in the United States It is also agreed that Avecia will flow-down
language similar to that in this paragraph to its subcontracts not performed in
the United States; i.e., FAR 52.222-37 would apply in its entirety to any
second-tier (or lower) subcontracts performed in the United States.


 


9
















 


Contract
No. N01-AI-30052


 


SECTION C
- DESCRIPTION/SPECIFICATIONS/WORK STATEMENT


 


ARTICLE C.1.  STATEMENT OF WORK


 


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


 


ARTICLE C.2.  REPORTING REQUIREMENTS


 


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


 


b.             Technical Reports


 


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


 


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


 


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


 


b.                                      SECTION I -
An introduction covering the purpose and scope of the contract effort;


 


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


 


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


 


e.                                       SECTION IV
- Estimated and Actual Expenses


 


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


 


10

















 


Contract
No. N01-AI-30052


 


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


 


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


 


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


 


ARTICLE C.3.  INVENTION REPORTING REQUIREMENT


 


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


 


Contracting Officer


National Institutes of Health


National Institute of Allergy and Infectious Diseases, CMB


6700-B Rockledge Drive, Room 2230


Bethesda, Maryland 20892 -7612


 


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


 


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


 


SECTION D
- PACKAGING, MARKING AND SHIPPING


 


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


 


SECTION E
- INSPECTION AND ACCEPTANCE


 


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


 


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


 


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


 


11





















 


Contract
No. N01-AI-30052


 


otherwise indicated in writing by the Contracting Officer or the duly
authorized representative within 30 days of receipt.


 


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


 


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


 


SECTION F
- DELIVERIES OR PERFORMANCE


 


ARTICLE F.1.  DELIVERIES


 


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


 


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


 


	
  Item

  	
   

  	
  Description

  	
   

  	
  Delivery Schedule

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  Monthly
  Progress Reports

  	
   

  	
  Fifteenth of
  each month

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  Milestone
  Reports

  	
   

  	
  On the
  fifteenth day after completion of each milestone

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3

  	
   

  	
  Final Report

  	
   

  	
  Expiration
  Date of the Contract

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4

  	
   

  	
  Summary of
  Salient Results

  	
   

  	
  With the
  Final Report

  	
   

  



 


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


 


	
  Addressee

  	
   

  	
  Deliverable
  Item

  	
   

  	
  Quantity

  	
   

  
	
  Contracting
  Officer

  	
   

  	
  Monthly
  Progress Reports

  	
   

  	
  Original

  	
   

  
	
  CMB, NIAID, NIH

  	
   

  	
  Milestone Reports

  	
   

  	
  Original

  	
   

  
	
  Room 2230, MSC 7612

  	
   

  	
  Final Report

  	
   

  	
  Original

  	
   

  
	
  6700-B Rockledge Drive

  	
   

  	
  Summary of Salient Results

  	
   

  	
  Original

  	
   

  
	
  Bethesda, MD 20892-7612

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Project Officer

  	
   

  	
  Monthly
  Progress Reports

  	
   

  	
  5 Copies

  	
   

  
	
  DMID/NIAID/NIH

  	
   

  	
  Milestone Reports

  	
   

  	
  5
  Copies

  	
   

  
	
  6610 Rockledge Dr.,

  	
   

  	
  Final Report

  	
   

  	
  5
  Copies

  	
   

  
	
  Room 5002

  	
   

  	
  Summary of Salient Results

  	
   

  	
  5
  Copies

  	
   

  
	
  Bethesda, MD 20892-7630

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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Contract
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c.                                       Other
Reports/Deliverables


 


The following
are considered deliverables under this contract:


 


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


 


6.                                       All
milestones indicated in the Statement of Work.


 


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


 


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


 


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


 


FEDERAL
ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:


 


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


 


SECTION G
- CONTRACT ADMINISTRATION DATA


 


ARTICLE G.1.  PROJECT OFFICER


 


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


 


Ed Nuzum, DVM, Ph.D.

Project Officer

Office of Biodefense Research Affairs (OBRA)/DMID/NIAID/NIH

Mail Stop Code 6604

6610 Rockledge Drive, Room 5117

Bethesda, MD 20892-6604

Phone: (301) 451-6737

Fax: (301) 480-1263

Email:  enuzum@niaid.nih.gov


 


Eileen Flynn

Co-Project Officer

Office of Biodefense Research Affairs (OBRA)/DMID/NIAID/NIH

Mail Stop Code 7630

6610 Rockledge Drive, Room 5002

Bethesda, MD 20892-7630

Phone: (301) 451-6737

Fax:         (301)
480-1263

Email:  eflynn@niaid.nih.gov


 


The Project
Officer is responsible for:  (I) 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.


 


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Contract
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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: (l) direct or negotiate any changes
in the Statement of Work; (2) modify or extend the period of performance; (3) change
the delivery schedule; (4) authorize reimbursement to the Contractor any
costs incurred during the performance of this contract; or (5) otherwise
change any terms and conditions of this contract.


 


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


 


The Government
may unilaterally change its Project Officer designation.


 


ARTICLE G.2.  KEY PERSONNEL


 


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


 


	
  Name

  	
   

  	
  Title

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Matthew G.
  Duchars, BSc, PhD

  	
   

  	
  Principal
  Investigator

  	
   

  



 


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


 


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


 


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


 


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


 


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


 


Contracting Officer

Contract Management Branch

National Institute of Allergy and Infectious Diseases, NIH

Room 2230

6700-B ROCKLEDGE DRIVE, MSC 7612

BETHESDA, MD 20892-7612


 


(2)                                  Inquiries regarding
payment of invoices should be directed to the designated billing office,
(301)496-0612.


 


b.                                      The Contractor
shall include the following certification on every invoice for reimbursable
costs incurred with Fiscal Year funds subject to the salary rate limitation
provisions as specified in ARTICLE H.11. of this contract.  For billing purposes, certified invoices are
required for the billing period during which the applicable Fiscal Year funds
were initially charged through the final billing period utilizing the
applicable Fiscal Year funds:


 


“I hereby certify that the
salaries charged in this invoice are in compliance with P.L.  108-7 and ARTICLE H.11.  of the above referenced contract.”


 


ARTICLE G.4.  INDIRECT COST RATES


 


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


 


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Contract
No. N01-AI-30052


 


Director, Division of Financial
Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6100 Building, Room 6B05

6100 EXECUTIVE BLVD MSC 7540

BETHESDA MD 20892-7540


 


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


 


ARTICLE G.5.  GOVERNMENT PROPERTY


 


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


 


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


 


Division of Personal Property
Services, NIH

6011 Building, Suite 637

6011 EXECUTIVE BLVD MSC 7670

BETHESDA MD 20852-7670

(301) 496-6466


 


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


 


ARTICLE G.6.  POST AWARD EVALUATION OF CONTRACTOR
PERFORMANCE


 


a.                                       Contractor
Performance Evaluations


 


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


 


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


 


Copies of the
evaluations, contractor responses, and review comments, if any, will be
retained as part of the contract file, and may be used to support future award
decisions.


 


b.                                      Electronic
Access to Contractor Performance Evaluations


 


Contractors
that have Internet capability may access evaluations through a secure Web site
for review and comment by completing the registration form that can be obtained
at the following address:


 


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


 


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Contract
No. N01-AI-30052


 


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.


 


SECTION H
- SPECIAL CONTRACT REQUIREMENTS


 


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


 


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


 


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


 


ARTICLE H.2.  HUMAN SUBJECTS


 


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


 


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


 


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


 


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


 


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


 


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


 


The Contractor
is directed to the full text of the NIH Policy regarding Data and Safety
Monitoring and Reporting of Adverse


 


Events, which
may be found at the following web sites:


 


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


http://grants.nih.gov/grants/guide/notice-files/not99-107.html I07


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


 


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


 


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


 


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


 


ARTICLE H.5.  HUMAN MATERIALS


 


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


 


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


 


	
  a.

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

  
	
   

  	
   

  
	
   

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

  



 


	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 108-7,
  Division G, Title V-General Provisions, Section 510

  	
   

  	
  2003

  	
   

  	
  10/1/02 -
  9/30/03

  	
   

  



 


ARTICLE H.7.  NEEDLE EXCHANGE


 


	
  a.

  	
  Pursuant to
  Public Law(s) cited in paragraph b., below, contract funds shall not be
  used to carry out any program of distributing sterile needles or syringes for
  the hypodermic injection of any illegal drug.

  



 


	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 108-7,
  Division G, Title V-General Provisions, Section 505

  	
   

  	
  2003

  	
   

  	
  10/1/02 -
  9/30/03

  	
   

  



 


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Contract
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ARTICLE H.8.  PRIVACY ACT


 


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


 


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


 


ARTICLE H.9.  INTRODUCTION OF RODENTS AND RODENT
PRODUCTS


 


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


 


ARTICLE H.10.  ANIMAL WELFARE


 


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


 


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


 


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


 


ARTICLE H.12.  SALARY RATE LIMITATION LEGISLATION
PROVISIONS


 


	
  a.

  	
   

  	
  Pursuant to
  Public Law(s) cited in paragraph b., below, no NIH Fiscal Year funds may
  be used to pay the direct salary of an individual through this contract at a
  rate in excess of applicable amount shown for the fiscal year covered.  Direct salary is exclusive of fringe
  benefits, overhead, and general and administrative expenses (also referred to
  as “indirect cost” or “facilities and administrative (F&A) costs”).  Direct salary has the same meaning as the
  term “institutional base salary.” An individual’s direct salary (or
  institutional base salary) is the annual compensation that the contractor pays
  for an individual’s appointment whether that individual’s time is spent on
  research, teaching, patient care or other activities.  Direct salary (or institutional base
  salary) excludes any income that an individual may be permitted to earn
  outside of duties to the contractor. 
  The per year salary rate limit also applies to individuals proposed
  under subcontracts.  It does not apply
  to fees paid to consultants.  If this
  is a multiple year contract, it may be subject to unilateral modifications by
  the Government if an individual’s salary rate exceeds any salary rate ceiling
  established in future HHS appropriation acts.

  



 


	
  b.

  	
   

  	
  Public Law No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Dollar
  Amount of Salary

  Limitation*

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  P.L. 108-7,
  Division G, Title II-General Provisions, Section 204

  	
   

  	
  2003

  	
   

  	
  Executive
  Level 1

  



 


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Contract
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b.                                      Direct salaries
which will be paid with FY-03 funds are limited to the Executive Level I rate
which was in effect on the date(s) the expense was incurred.


 










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


 


LINK to EXECUTIVE LEVEL SALARIES: 
http://opm.gov.oca/PAYRATES/index.htm


(Click on “Executive Schedule” for the current Fiscal Year’s salary
rate or scroll down to the “General Schedule Salary Tables from Previous Years”
to locate the Executive Level salary rates from previous years.)


 


ARTICLE H.13.  PUBLICATION AND PUBLICITY


 


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


 


“This project
has been funded in whole or in part with Federal funds from the National
Institute of Allergy and Infectious Diseases, National Institutes of Health
Department of Health and Human Services, under Contract No.  N01-AI-
30052.”


 


ARTICLE H.14.  PRESS RELEASES


 


a.                                       Pursuant to
Public Law(s) cited in paragraph b., below, the contractor shall clearly
state, when issuing statements, press releases, requests for proposals, bid
solicitations and other documents describing projects or programs funded in
whole or in part with Federal money: (1) the percentage of the total costs
of the program or project which will be financed with Federal money; (2) the
dollar amount of Federal funds for the project or program; and (3) the
percentage and dollar amount of the total costs of the project or program that
will be financed by nongovernmental sources.


 


	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  P.L. 108-7,
  Division G, Title V-General Provisions, Section 507

  	
   

  	
  2003

  	
   

  	
  10/1/02 -
  9/30/03

  



 


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


 


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


 


	
   

  	
  Office of Inspector General

  
	
   

  	
  Department of Health and Human Services

  
	
   

  	
  TIPS HOTLINE

  
	
   

  	
  P.O.  Box 23489

  
	
   

  	
  Washington, D.C. 20026

  



 


ARTICLE H.16.  ANTI -LOBBYING


 


a.                                       Pursuant to
Public Law(s) cited in paragraph c, below, contract funds shall not be
used, other than for normal and recognized executive-legislative relationships,
for publicity or propaganda purposes, for the preparation, distribution, or use
of any kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support or defeat legislation pending before the
Congress or any State legislature, except in presentation to the Congress or
any State legislature itself.


 


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Contract
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b.                                      Contract funds
shall not be used to pay salary or expenses of the contractor or any agent
acting for the contractor, related to any activity designed to influence
legislation or appropriations pending before the Congress or any State
legislature.


 


	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  for a.,
  above: P.L. 108-7, Division G, Title V-General Provisions, Section 503a

  	
   

  	
  2003

  	
   

  	
  10/1/02 -
  9/30/03

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  for b.,
  above: P.L. 108-7, Division G, Title V. General Provisions, Section 503b

  	
   

  	
  2003

  	
   

  	
  10/1/02 -
  9/30/03

  



 


ARTICLE H.17.  OBTAINING AND DISSEMINATING BIOMEDICAL
RESEARCH RESOURCES


 


Unique
research resources arising from NIH-funded research are to be shared with the
scientific research community.  NIH
provides guidance, entitled, “Sharing Biomedical Research Resources: Principles
and Guidelines for Recipients of NIH Research Grants and Contracts,” (Federal
Register Notice, December 23, 1999 [64 FR 72090]), concerning the
appropriate terms for disseminating and acquiring these research
resources.  This guidance, found at:


http://ott.od.nih.gov/NewPages/64FR72090.pdf
is intended to help contractors ensure that the conditions they impose and
accept on the transfer of research tools will facilitate further biomedical
research, consistent with the requirements of the Bayh-Dole Act and NIH funding
policy.


 


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


 


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


 


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


 


ARTICLE H.19.  OFFICE OF HEALTH AND SAFETY -
LABORATORY REGISTRATION/SELECT AGENT TRANSFER PROGRAM


 


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


 


ARTICLE H.20.  SELECT AGENT AWARDS TO FOREIGN
CONTRACTORS STATUS


 


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


 


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


 


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


 


For
possession, use and transfer of biological agents or toxins that have been
determined to have the potential to pose a severe threat to:  1) public health and safety; 2) both human
and animal health; animal health, or animal products; and/or 3) plant health or
plant products, registration information must be submitted to the Centers for
Disease Control and Prevention,


 


20

















 


Contract
No. N01-AI-30052


 


Department of
Health and Human Services (DHHS) or the Animal and Plant Health inspection
Service (APHIS), U.S.  Department of
Agriculture (USDA) as applicable.


 


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


 


21

















 


Contract
No. N01-AI-30052


 


PART II - CONTRACT
CLAUSES


 


SECTION I
- CONTRACT CLAUSES


 


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


 


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


 


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


 


	
  FAR

  CLAUSE NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.202-1

  	
   

  	
  Dec 2001

  	
   

  	
  Definitions

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-3

  	
   

  	
  Apr 1984

  	
   

  	
  Gratuities
  (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-5

  	
   

  	
  Apr 1984

  	
   

  	
  Covenant
  Against Contingent Fees (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-6

  	
   

  	
  Jul 1995

  	
   

  	
  Restrictions
  on Subcontractor Sales to the Government (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-7

  	
   

  	
  Jul 1995

  	
   

  	
  Anti-Kickback
  Procedures(Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-8

  	
   

  	
  Jan 1997

  	
   

  	
  Cancellation,
  Rescission, and Recovery of Funds for Illegal or Improper Activity (Over
  $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-10

  	
   

  	
  Jan 1997

  	
   

  	
  Price or Fee
  Adjustment for Illegal or Improper Activity (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.203-12

  	
   

  	
  Jun 2003

  	
   

  	
  Limitation
  on Payments to Influence Certain Federal Transactions (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.204-4

  	
   

  	
  Aug 2000

  	
   

  	
  Printed or
  Copied Double-Sided on Recycled Paper (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.209-6

  	
   

  	
  Jul 1995

  	
   

  	
  Protecting
  the Government’s Interests When Subcontracting With Contractors Debarred,
  Suspended, or Proposed for Debarment (Over $25,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-2

  	
   

  	
  Jun 1999

  	
   

  	
  Audit and
  Records - Negotiation (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-8

  	
   

  	
  Oct 1997

  	
   

  	
  Order of
  Precedence - Uniform Contract Format

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-10

  	
   

  	
  Oct 1997

  	
   

  	
  Price
  Reduction for Defective Cost or Pricing Data

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-12

  	
   

  	
  Oct 1997

  	
   

  	
  Subcontractor
  Cost or Pricing Data (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-14

  	
   

  	
  Oct 1997

  	
   

  	
  Integrity of
  Unit Prices (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-15

  	
   

  	
  Dec 1998

  	
   

  	
  Pension
  Adjustments and Asset Reversions

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-18

  	
   

  	
  Oct 1997

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-19

  	
   

  	
  Oct 1997

  	
   

  	
  Notification
  of Ownership Changes

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.215-21

  	
   

  	
  Oct 1997

  	
   

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

  



 


22

















 


Contract
No. N01-AI-30052


 


	
  52.216-7

  	
   

  	
  Dec 2002

  	
   

  	
  Allowable
  Cost and Payment

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.216-8

  	
   

  	
  Mar 1997

  	
   

  	
  Fixed Fee

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.219-8

  	
   

  	
  Oct 2000

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.219-9

  	
   

  	
  Jan 2002

  	
   

  	
  Small
  Business Subcontracting Plan (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.219-16

  	
   

  	
  Jan 1999

  	
   

  	
  Liquidated
  Damages - Subcontracting Plan (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-2

  	
   

  	
  Jul 1990

  	
   

  	
  Payment for
  Overtime Premium (Over $100,000) (Note: The dollar amount in paragraph
  (a) of this clause is $0 unless otherwise specified in the contract.)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-3

  	
   

  	
  Jun 2003

  	
   

  	
  Convict
  Labor

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-26

  	
   

  	
  Apr 2002

  	
   

  	
  Equal Opportunity

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-35

  	
   

  	
  Dec 2001

  	
   

  	
  Equal
  Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and
  Other Eligible Veterans

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-36

  	
   

  	
  Jun 1998

  	
   

  	
  Affirmative
  Action for Workers with Disabilities

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.222-37

  	
   

  	
  Dec 2001

  	
   

  	
  Employment
  Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other
  Eligible Veterans

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.223-6

  	
   

  	
  May 2001

  	
   

  	
  Drug-Free
  Workplace

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.223-14

  	
   

  	
  Jun 2003

  	
   

  	
  Toxic
  Chemical Release Reporting

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.225-1

  	
   

  	
  Jun 2003

  	
   

  	
  Buy American
  Act - Supplies

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.225-13

  	
   

  	
  Jun 2003

  	
   

  	
  Restrictions
  on Certain Foreign Purchases

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.227-1

  	
   

  	
  Jul 1995

  	
   

  	
  Authorization
  and Consent, Alternate I (Apr 1984)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.227-2

  	
   

  	
  Aug 1996

  	
   

  	
  Notice and
  Assistance Regarding Patent and Copyright Infringement (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.227-11

  	
   

  	
  Jun 1997

  	
   

  	
  Patent
  Rights - Retention by the Contractor (Short Form) (Note: In accordance with
  FAR 27.303(a)(2), paragraph (f) is modified to include the requirements
  in FAR 27.303(a)(2)(1) through (iv). The frequency of reporting in (I) is
  annual.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.227-14

  	
   

  	
  Jun 1987

  	
   

  	
  Rights in
  Data - General

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-9

  	
   

  	
  Apr 1984

  	
   

  	
  Limitation
  on Withholding of Payments

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-17

  	
   

  	
  Jun 1996

  	
   

  	
  Interest
  (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-20

  	
   

  	
  Apr 1984

  	
   

  	
  Limitation
  of Cost

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-23

  	
   

  	
  Jan 1986

  	
   

  	
  Assignment
  of Claims

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-25

  	
   

  	
  Feb 2002

  	
   

  	
  Prompt
  Payment, Alternate I (Feb 2002)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.232-34

  	
   

  	
  May 1999

  	
   

  	
  Payment by
  Electronic Funds Transfer-Other Than Central Contractor Registration

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.233-1

  	
   

  	
  Jul 2002

  	
   

  	
  Disputes

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.233-3

  	
   

  	
  Aug 1996

  	
   

  	
  Protest
  After Award, Alternate I (Jun 1985)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.242-1

  	
   

  	
  Apr 1984

  	
   

  	
  Notice of
  Intent to Disallow Costs

  



 


23

















 


Contract
No. N01-AI-30052


 


	
  52.242-3

  	
   

  	
  May 2001

  	
   

  	
  Penalties
  for Unallowable Costs (Over $500,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.242-4

  	
   

  	
  Jan 1997

  	
   

  	
  Certification
  of Final Indirect Costs

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.242-13

  	
   

  	
  Jul 1995

  	
   

  	
  Bankruptcy
  (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.243-2

  	
   

  	
  Aug 1987

  	
   

  	
  Changes -
  Cost Reimbursement, Alternate V (Apr 1984)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.244-2

  	
   

  	
  Aug 1998

  	
   

  	
  Subcontracts,
  Alternate II (Aug 1998) *If written consent to subcontract is required, the
  identified subcontracts are listed in ARTICLE B, Advance Understandings.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.244-5

  	
   

  	
  Dec 1996

  	
   

  	
  Competition
  in Subcontracting (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.245-5

  	
   

  	
  Jun 2003

  	
   

  	
  Government
  Property (Cost-Reimbursement, Time and Material, or Labor-Hour Contract)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.246-23

  	
   

  	
  Feb 1997

  	
   

  	
  Limitation
  of Liability (Over $100,000)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.249-6

  	
   

  	
  Sep 1996

  	
   

  	
  Termination
  (Cost-Reimbursement)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.249-14

  	
   

  	
  Apr 1984

  	
   

  	
  Excusable
  Delays

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  52.253-1

  	
   

  	
  Jan 1991

  	
   

  	
  Computer
  Generated Forms

  



 


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


 


	
  HHSAR

  CLAUSE

  NO.

  	
   

  	
  DATE

  	
   

  	
  TITLE

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.202-1

  	
   

  	
  Jan 2001

  	
   

  	
  Definitions
  - with Alternate paragraph (h) (Jan 2001)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.216-72

  	
   

  	
  Oct 1990

  	
   

  	
  Additional
  Cost Principals

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.228-7

  	
   

  	
  Dec 1991

  	
   

  	
  Insurance -
  Liability to Third Persons

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.232-9

  	
   

  	
  Apr 1984

  	
   

  	
  Withholding
  of Contract Payments

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.233-70

  	
   

  	
  Apr 1984

  	
   

  	
  Litigation
  and Claims

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.242-71

  	
   

  	
  Apr 1984

  	
   

  	
  Final
  Decisions on Audit Findings

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.270-5

  	
   

  	
  Apr 1984

  	
   

  	
  Key
  Personnel

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.270-6

  	
   

  	
  Jul 1991

  	
   

  	
  Publications
  and Publicity

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  352.270-7

  	
   

  	
  Jan 2001

  	
   

  	
  Paperwork
  Reduction Act

  



 


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


 


ARTICLE I.2.  AUTHORIZED SUBSTITUTION OF CLAUSES


 


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


 


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


 


24

















 


Contract
No. N01-AI-30052


 


applicable.


 


ARTICLE I.3.  ADDITIONAL CONTRACT CLAUSES


 


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


 


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


 


(1)                                  FAR
52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997).


 


(2)                                  FAR
52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (JANUARY 1999).


 


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


 


[ ]                                     Offeror
elects to waive the evaluation preference.”


 


(3)                                  FAR
52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged
Business Concerns (JUNE 2003).


 


“(b)                           Evaluation
adjustment.  (1) The Contracting
Officer will evaluate offers by adding a factor of 10% to the price of all
offers, except—...”


 


(4)                                  FAR
52.224- 1, Privacy Act Notification (APRIL 1984)


 


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


 


(6)                                  FAR
52.225-5, Trade Agreements Act


 


(7)                                  FAR
52.227-14, Rights in Data - General (JUNE 1987)


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


(2)                                  NIH(RC)
[   ], Research Patient Care Costs
(4/1/84).


 


25

















 


Contract
No. N01-AI-30052


 


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


 


This contract
incorporates the following clauses in full text.


 


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


 


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


 


(a)                      Definitions.  As used in this clause-


 


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


 


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


 


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


 


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


 


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


 


(ii)           52.222-26,
Equal Opportunity (APR 2002) (E.O. 
11246).


 


(iii)          52.222-35,
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (DEC 2001) (38 U.S.C.  4212(a)).


 


(iv)          52.222-36,
Affirmative Action for Workers with Disabilities (JUN 1998) (29 U.S.C.  793).


 


(v)           52.247-64,
Preference for Privately Owned U.S. - Flag Commercial Vessels (APR 2003) (46
U.S.C.  Appx 1241 and 10 U.S.C.  2631) (flow down required in accordance with
paragraph (d) of FAR clause 52.247 64).


 


(2)                                  While
not required, the Contractor may flow down to subcontracts for commercial items
a minimal number of additional clauses necessary to satisfy its contractual
obligations.


 


(d)                                 The
Contractor shall include the terms of this clause, including this paragraph
(d), in subcontracts awarded under this contract.


 


26
















 


Contract
No. N01-AI-30052


 


PART III


 


SECTION J
- LIST OF ATTACHMENTS


 


The following
documents are attached and incorporated in this contract:


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


27

















 


Contract
No. N01-AI-30052


 


PART IV


 


SECTION K
- REPRESENTATIONS AND CERTIFICATIONS


 


The following
documents are incorporated by reference in this contract:


 


1.                                       Representations
and Certifications, dated September 4, 2003


 


2.                                       Human
Subjects Assurance Identification Number FWA00004876, dated June 6, 2003


 


3.                                       Animal
Welfare Assurance Number for Subcontractor DSTL, A5537-01, dated October 7,
2002.


 


END of the
SCHEDULE

(CONTRACT)


 


28

















 


Contract
No. N01-AI-30052


 


Statement of
Work


 


[***]


 


	
  Statement of
  Work

  	
   

  	
  ATTACHMENT 1

  
	
  (September
  30, 2003)

  	
   

  	
  Page 1

  



 

















 


Contract
No. N01-AI-30052


 


Statement of
Work


 


[***]


 


	
  Statement of
  Work

  	
   

  	
  ATTACHMENT 1

  
	
  (September
  30, 2003)

  	
   

  	
  Page 2

  



 

















 


Contract
No. N01-AI-30052


 


Statement of
Work


 


[***]


 


	
  Statement of
  Work

  	
   

  	
  ATTACHMENT 1

  
	
  (September
  30, 2003)

  	
   

  	
  Page 3

  



 

















 


Contract
No. N01-AI-30052


 


INVOICE/FINANCING
REQUEST AND CONTRACT FINANCIAL REPORTING

INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


(a)                                  Interim Invoice/Contract Financing Request - These are
interim payment requests submitted during the contract performance period.


 


(b)                                 Completion Invoice - The completion invoice is submitted
promptly upon completion of the work; but no later than one year from the
contract completion date, or within 120 days after settlement of the final
indirect cost rates covering the year in which this contract is physically
complete (whichever date is later).  The
completion invoice should be submitted when all costs have been assigned to the
contract and all performance provisions have been completed.


 


(c)                                  Final Invoice - A final invoice may be required after the
amounts owed have been settled between the Government and the contractor (e.g.,
resolution of all suspensions and audit exceptions).


 


Preparation and Itemization of the Invoice/Financing Request:  The contractor shall furnish the information
set forth in the explanatory notes below. 
These notes are keyed to the entries on the sample invoice/financing
request.


 


(a)                                  Designated Billing Office Name and Address - Enter the
designated billing office and address, identified in the Invoice Submission
Clause of the contract, on all copies of the invoice/financing request.


 


(b)                                 Invoice/Financing Request Number - Insert the appropriate
serial number of the invoice/financing request.


 


(c)                                  Date Invoice/Financing Request Prepared - Insert the date
the invoice/financing request is prepared.


 


	
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Contract
No. N01-AI-30052


 


(d)           Contract
Number and Date - Insert the contract number and the effective date
of the contract.


 


(e)           Payee’s Name
and Address - Show the contractors name (as it appears in the
contract), correct address, and the title and phone number of the responsible
official to whom payment is to be sent. 
When an approved assignment has been made by the contractor, or a
different payee has been designated, then insert the name and address of the
payee instead of the contractor.


 


(f)            Total Estimated
Cost of Contract - Insert the total estimated cost of the contract,
exclusive of fixed-fee.  For
incrementally funded contracts, enter the amount currently obligated and
available for payment.


 


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


 


(h)           Billing
Period - Insert the beginning and ending dates (month, day, and
year) of the period in which costs were incurred and for which reimbursement is
claimed.


 


(i)            Incurred
Cost - Current - Insert the amount billed for the major cost
elements, adjustments, and adjusted amounts for the current period.


 


(j)            Incurred
Cost - Cumulative - Insert the cumulative amounts billed for the
major cost elements and adjusted amounts claimed during this contract.


 


(k)           Direct Costs
- Insert the major cost elements.  For
each element, consider the application of the paragraph entitled “Costs
Requiring Prior Approval” on page 1 of these instructions.


 


(1)           Direct Labor
- Include salaries and wages paid (or accrued) for direct performance of the
contract.  For Key Personnel, list each
employee on a separate line.  List other
employees as one amount unless otherwise required by the contract.


 


(2)           Fringe Benefits
- List any fringe benefits applicable to direct labor and billed as a direct
cost.  Fringe benefits included in
indirect costs should not be identified here.


 


(3)           Accountable
Personal Property - Include permanent research equipment and general
purpose equipment having a unit acquisition cost of S1,000 or more and having
an expected service life of more than two years, and sensitive property
regardless of cost (see the DHHS Contractor’s Guide for
Control of Government Property). 
Show permanent research equipment separate from general purpose
equipment.  Prepare and attach Form HHS-565,
“Report of Accountable Property,” in accordance with the following
instructions:


 


List each item for which
reimbursement is requested.  A reference
shall be made to the following (as applicable):


 


·                                          The
item number for the specific piece of equipment listed in the Property
Schedule.


 


·                                          The Contracting Officer’s
Authorization letter and number, if the equipment is not covered by the
Property Schedule.


 


·                                          Be
preceded by an asterisk (*) if the equipment is below the approval level.


 


(4)           Materials
and Supplies- Include equipment with unit costs of less than $1,000
or an expected service life of two years or less, and consumable material and
supplies regardless of amount.


 


(5)           Premium Pay
- List remuneration in excess of the basic hourly rate.


 


(6)           Consultant
Fee - List fees paid to consultants. 
Identify consultant by name or category as set forth in the contract’s
Advance Understanding or in the COA letter, as well as the effort (i.e., number
of hours, days, etc.) and rate being billed.


 


(7)           Travel
- Include domestic and foreign travel. 
Foreign travel is travel outside of Canada, the United States and its
territories and possessions.  However,
for an organization located outside Canada, the United States and its
territories and possessions, foreign travel means travel outside that
country.  Foreign travel must be


 


	
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Contract
No. N01-AI-30052


 


(8)           billed separately from
domestic travel.


 


(9)           Subcontract
Costs - List subcontractor(s) by name and amount billed.


 


(10)         Other
- List all other direct costs in total unless exceeding $1,000 in amount.  If over $1,000, list cost elements and dollar
amounts separately.  If the contract
contains restrictions on any cost element, that cost element must be listed
separately.


 


(l)            Cost of
Money (COM) - Cite the COM factor and base in effect during the time
the cost was incurred and for which reimbursement is claimed_


 


(m)          Indirect
Costs-Overhead - Identify the cost base, indirect cost rate, and
amount billed for each indirect cost category.


 


(n)           Fixed-Fee
Earned - Cite the formula or method of computation for the fixed-fee
(if any).  The fixed-fee must be claimed
as provided for by the contract.


 


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


 


(p)           Adjustments
- Include amounts conceded by the contractor, outstanding suspensions, and/or
disapprovals subject to appeal.


 


(q)           Grand Totals


 


The contracting officer may require the contractor to submit detailed
support for costs claimed on one or more interim invoices/financing requests.


 


	
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Contract
No. N01-AI-30052


 


FINANCIAL REPORTING INSTRUCTIONS:


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 


	
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Contract
No. N01-AI-30052


 


SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT


 


	
  (a)

  	
  Billing Office Name and Address

  
	
   

  	
   

  
	
   

  	
  NATIONAL INSTITUTES OF HEALTH

  
	
   

  	
  National Institute of Allergy and Infectious Diseases. 

  
	
   

  	
  Room 2230, MSC 7612

  
	
   

  	
  6700-B Rockledge Drive

  
	
   

  	
  Bethesda, MD 20892-7612

  
	
   

  	
   

  
	
  (b)

  	
  Invoice/Financing Request No.

  
	
   

  	
   

  
	
  (c)

  	
  Date Invoice Prepared

  
	
   

  	
   

  
	
  (d)

  	
  Contract No.

  
	
   

  	
   

  
	
  Effective Date

  
	
   

  	
   

  
	
  (e)

  	
  Payee’s Name and Address

  
	
   

  	
   

  
	
   

  	
  ABC CORPORATION

  
	
   

  	
  100 Main Street

  
	
   

  	
  Anywhere, USA zip code

  
	
   

  	
   

  
	
  Attn:

  	
  Name, Title, & Phone Number of Official to Whom Payment is
  Sent

  
	
   

  	
   

  
	
  (f)

  	
  Total Estimated Cost

  
	
   

  	
   

  
	
  (g)

  	
  Total Fixed Fee

  
	
   

  	
   

  
	
  (h)

  	
  This invoice/financing request represents reimbursable costs for the
  period from                to                

  



 


	
   

  	
   

  	
  Cumulative Percentage of

  Effort/Hrs.

  	
   

  	
  Incurred Cost

  	
   

  	
  Cost at

  Completion

  F

  	
   

  	
  Contract

  Amount

  G

  	
   

  	
  Variance

  H

  	
   

  
	
  Expenditure Category*

  A

  	
   

  	
  Negotiated

  B

  	
   

  	
  Actual

  C

  	
   

  	
  (i) Current

  D

  	
   

  	
  (j) Cumulative

  E

  	
   

  
	
  (k)  Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Direct Labor

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (2) Fringe Benefits

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (3) Accountable Property (attach
  HHS-565)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (4) Materials & Supplies

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (5) Premium Pay

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (6) Consultant Fees

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (7) Travel

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (8) Subcontracts

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (9) Other

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (l)  Cost of Money

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (m)  Overhead

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  G&A

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (n)  Fixed Fee

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (o)  Total Amount Claimed

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (p)  Adjustments

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (q)  Grand Totals

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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


 


	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
          (Name
  of Official)

  	
   

  	
         (Title)

  	
   

  



 






* Attach details as specified in the contract


 


	
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Contract
No. N01-AI-30052


 


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

  
	
   

  	
   

  	
  Females

  	
   

  	
  Males

  	
   

  	
  Unknown or Not
  Reported

  	
   

  	
  Total

  
	
  Ethnic Category

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Hispanic or Latino

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Not Hispanic or
  Latino

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown (Individuals
  not reporting ethnicity)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Ethnic Category:
  Total of All Subjects*

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Racial
  Categories

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  American
  Indian/Alaska Native

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Asian

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Native Hawaiian or
  Other Pacific Islander

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Black or African
  American

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  White

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  More than one race

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown or not
  reported

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Racial Categories:
  Total of All Subjects*

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


PART B.  HISPANIC ENROLLMENT REPORT:  Number of Hispanics or Latinos Enrolled to
Date (Cumulative)


 


	
   

  	
   

  	
  Females

  	
   

  	
  Males

  	
   

  	
  Unknown or Not Reported

  	
   

  	
  Total

  
	
  Racial Categories

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  American Indian or
  Alaska Native

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Asian

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Native Hawaiian or
  Other Pacific Islander

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Black or African
  American

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  White

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  More Than One Race

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown or not
  reported

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Racial Categories: Total of Hispanics or
  Latinos**

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 






*These totals must agree


**These totals must agree


 


	
  Inclusion
  Enrollment Report

  	
  ATTACHMENT 3

  
	
  5/2001 (Modified
  OAMP: 10/2001)

  	
   

  



 

















 


Contract
No. N01-AI-30052


 


ANNUAL TECHNICAL PROGRESS REPORT FORMAT


 


Study Title:


Date:


 


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


 


	
   

  	
   

  	
  American

  Indian or

  Alaskan

  Native

  	
   

  	
  Asian or

  Pacific

  Islander

  	
   

  	
  Black,

  not of

  Hispanic

  Origin

  	
   

  	
  Hispanic

  	
   

  	
  White,

  not of

  Hispanic

  Origin

  	
   

  	
  Other

  or

  Unknown

  	
   

  	
  Total

  	
   

  
	
  Female

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Male

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Unknown

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


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


 


	
  Annual
  Technical Progress Report Format

  	
  ATTACHMENT 4

  
	
  July, 1994

  	
   

  



 
















 


Contract No. N01-AI-30052


 


HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001)


 


(a)                                  To
help ensure the protection of the life and health of all persons and to help
prevent damage to property, the Contractor shall comply with all Federal, State
and local laws and regulations applicable to the work being performed under the
contract.  These laws are implemented
and/or enforced by the Environmental Protection Agency, Occupational Safety and
Health Administration and other agencies at the Federal, State and local levels
(Federal, State and local regulatory/enforcement agencies).


 


(b)                                 Further,
the Contractor shall take or cause to be taken additional safety measures as
the Contracting Officer in conjunction with the project or other appropriate
officer, determines to be reasonably necessary. 
If compliance with these additional safety measures results in an
increase or decrease in the cost or time required for performance of any part
of work under this contract, an equitable adjustment will be made in accordance
with the applicable “Changes” Clause set forth in this contract.


 


(c)                                  The
Contractor shall maintain an accurate record of, and promptly report to the
Contracting Officer, all accidents or incidents resulting in the exposure of
persons to toxic substances, hazardous materials or hazardous operations; the
injury or death of any person; and/or damage to property incidental to work
performed under the contract and all violations for which the Contractor has
been cited by any Federal, State or local regulatory/enforcement agency.  The report shall include a copy of the notice
of violation and the findings of any inquiry or inspection, and an analysis
addressing the impact these violations may have on the work remaining to be performed.  The report shall also state the required
action(s), if any, to be taken to correct any violation(s) noted by the
Federal, State or local regulatory/enforcement agency and the time frame
allowed by the agency to accomplish the necessary corrective action.


 


(d)                                 If
the Contractor fails or refuses to comply promptly with the Federal, State or
local regulatory/enforcement agency’s directive(s) regarding any violation(s) and
prescribed corrective action(s), the Contracting Officer may issue an order
stopping all or part of the work until satisfactory corrective action (as
approved by the Federal, State or local regulatory/enforcement agencies) has
been taken and documented to the Contracting Officer.  No part of the time lost due to any stop work
order shall be subject to a claim for extension of time or costs or damages by
the Contractor.


 


(e)                                  The
Contractor shall insert the substance of this clause in each subcontract
involving toxic substances, hazardous materials, or operations.  Compliance with the provisions of this clause
by subcontractors will be the responsibility of the Contractor.


 


(End
of clause)


 


	
  Safety and
  Health Clause

  	
  ATTACHMENT 5

  
	
  HHSAR
  352.223-70, (1/01)

  	
   

  



 





















 


Contract
No. N01-AI-30052


 


PROCUREMENT OF CERTAIN EQUIPMENT


 


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


 


	
  67 -

  	
  Photographic
  Equipment

  
	
  69 -

  	
  Training
  Aids and Devices

  
	
  70 -

  	
  General
  Purpose ADP Equipment, Software, Supplies and Support (Excluding 7045-ADP
  Supplies and Support Equipment.)

  
	
  71 -

  	
  Furniture

  
	
  72 -

  	
  Household
  and Commercial Furnishings and Appliances

  
	
  74 -

  	
  Office
  Machines and Visible Record Equipment

  
	
  77 -

  	
  Musical
  Instruments, Phonographs, and Home-type Radios

  
	
  78 -

  	
  Recreational
  and Athletic Equipment

  



 


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


 


	
  NIH(RC)-7
  (4/1/84)

  	
  ATTACHMENT 6

  
	
  OMB Bulletin
  81-16

  	
   

  



 





















 


Contract
No. N01-AI-30052


 


RESEARCH PATIENT CARE COSTS


 


(a)                                  Research
patient care costs are the costs of routine and ancillary services provided to
patients participating in research programs described in this contract.


 


(b)                                 Patient
care costs shall be computed in a manner consistent with the principles and
procedures used by the Medicare Program for determining the part of Medicare
reimbursement based on reasonable costs. 
The Diagnostic Related Group (DRG) prospective reimbursement method used
to determine the remaining portion of Medicare reimbursement shall not be used
to determine patient care costs.  Patient
care rates or amounts shall be established by the Secretary of HHS or his duly
authorized representative.


 


(c)                                  Prior
to submitting an invoice for patient care costs under this contract, the
contractor must make every reasonable effort to obtain third party payment,
where third party payors (including Government agencies) are authorized or are
under a legal obligation to pay all or a portion of the charges incurred under
this contract for patient care.


 


(d)                                 The
contractor must maintain adequate procedures to identify those research
patients participating in this contract who are eligible for third party
reimbursement.


 


(e)                                  Only
those charges not recoverable from third party payors or patients and which are
consistent with the terms and conditions of the contract are chargeable to this
contract.


 


	
  NIH(RC)-11

  	
  ATTACHMENT 7

  
	
  (4/1/84)

  	
   

  



 





















 


Contract No. N01-AI-30052


 


	
  REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY

  
	
   

  
	
  CONTRACTOR:

  	
  CONTRACT
  NUMBER

  
	
   

  	
   

  
	
  ADDRESS

  	
  REPORT DATE:

  
	
   

  	
   

  
	
   

  	
  FISCAL YEAR:

  
	
   

  	
   

  
	
   

  	
   

  



 


	
   

  	
   

  	
  BEGINNING OF

  PERIOD

  	
   

  	
  ADJUSTMENTS

  	
   

  	
  END OF PERIOD

  	
   

  
	
  CLASSIFICATION

  	
   

  	
  #ITEMS

  	
   

  	
  VALUE

  	
   

  	
  GFP

  ADDED

  	
   

  	
  CAP ADDED

  	
   

  	
  DELETIONS

  	
   

  	
  #ITEMS

  	
   

  	
  VALUE

  	
   

  
	
  LAND>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  LAND<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OTHER REAL>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  OTHER REAL<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER CONST>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER CONST<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PLANT EQUIP>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PLANT EQUIP<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TOOLING>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TOOLING<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TEST EQUIP>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  SPECIAL TEST EQUIP<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AGENCY PECULIAR>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  AGENCY PECULIAR<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  MATERIAL>=$25K (CUMULATIVE)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER MFR>=$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PROPERTY UNDER MFR<$25K

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  



 


	 
	
  SIGNED BY:

  	
   

  	
   

  	
   

  	
  DATE SIGNED:

  	
   

  	 

	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Report of
  Government Owned, Contractor Held Property

  	
  ATTACHMENT 8