Document:

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

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

12

 

Contract
No. N01-AI-30052

 

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.

 

13

 

Contract
No. N01-AI-30052

 

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:

 

14

 

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

 

15

 

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.

 

16

 

Contract
No. N01-AI-30052

 

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

  	
   

  

 

17

 

Contract
No. N01-AI-30052

 

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

  

 

18

 

Contract
No. N01-AI-30052

 

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.

 

19

 

Contract
No. N01-AI-30052

 

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 8Exhibit 10.45

 

	
  AMENDMENT
  OF SOLICITATION/MODIFICATION OF CONTRACT

  	
   

  	
  1. CONTRACT ID CODE

  	
   

  	
  PAGE OF PAGES

  
	
   

  	
   

  	
   

  	
   

  	
  1

  	
   

  	
  2

  

	
   

  	
   

  	
   

  	
   

  
	
  2.  AMENDMENT/MODIFICATION
  NO

  	
  3.  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE
  REQ. NO.

  	
  5.  PROJECT
  NO. (If applicable)

  
	
  01

  	
  See 16C

  	
  VR092

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  ISSUED BY

  	
  CODE

  	
  2668-30052

  	
  7.  ADMINISTERED
  BY (If other than Item 6)

  	
  CODE

  	
   

  
	
   

  National Institutes of
  Health

  Contract Management
  Branch, NIAID

  6700-B Rockledge Drive

  Room 2230, MSC 7612

  Bethesda, MD 20892-7612

   

  	
  DMID-VR

  
	
   

  
	
  8.  NAME AND ADDRESS OF CONTRACTOR (No., street, country, State and ZIP Code)

  	
  x

  	
  9A.  AMENDMENT
  OF SOLICITATION NO.

  
	
   

  
	
  Avacia Limited

  PO Box 42, Hexagon House

  Blackley

  Manchester, M9 8ZS

  England

  	
   

  	
  9B.  DATED (SEE ITEM 11)

   

  
	
  x

  	
  10A.  MODIFICATION
  OF CONTRACT/ORDER NO.

  
	
  NO1-AI-30052

   

  
	
   

  	
  10B.  DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
  September 30, 2003

  
	
   

  	
   

  	
   

  	
   

  
	
  11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF
  SOLICITATIONS

  
	
   

  
	
  o The above numbered solicitation is
  amended as set forth in Item 14.  The
  hour and date specified for receipt of Offers o is extended, o is not extended.

   

  Offers must acknowledge
  receipt of this amendment prior to the hour and date specified in the
  solicitation or as amended, by one of the following methods:  (a) By completing Items 8 and 15, and
  returning copies of the amendment; (b) By acknowledging receipt of this
  amendment on each copy of the offer submitted; or (c) By separate letter
  or telegram which includes a reference to the solicitation and amendment
  numbers.  FAILURE OF YOUR
  ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF
  OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF
  YOUR OFFER.  If by virtue of this
  amendment, you desire to change an offer already submitted, such change may
  be made by telegram or letter, provided each telegram or letter makes
  reference to the solicitation and this amendment, and is received prior to
  the opening hour and date specified.

   

  
	
  12.  ACCOUNTING AND APPROPRIATION DATA (If required)

  DOC#300N1AI30052A  EIN  1-900216013-A1     CAN  3-8460924                    SOCC#
  25.55                [***]

   

  
	
  13.  THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
  CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

   

  
	
   

  	
  A.

  	
  THIS
  CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

   

  
	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation date,
  etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

   

  
	
   

  	
  C.

  	
  THIS
  SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  
	
  x

  	
  D.

  	
  OTHER
  (Specify type of modification and authority)

  Unilateral
  - Article B.2.f.

   

  
	
  E.  IMPORTANT: 
  Contractor x is not, o is required to sign this document and return copies
  to the issuing office.

   

  
	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE: 
  The purpose of this modification is to add an increment of funds.

   

  
										

	
   

  	
   

  	
  TOTAL FUNDS ALLOTTED

  	
   

  	
  TOTAL ESTIMATED COST

  	
   

  
	
  AMOUNT

  	
   

  	
  Cost

  	
   

  	
  Fixed Fee

  	
   

  	
  CPFF

  	
   

  	
  Cost

  	
   

  	
  Fixed Fee

  	
   

  	
  CPFF

  	
   

  
	
  Total Prior to
  this MOD:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  MOD #01:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  TOTAL

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  COMPLETION DATE:  [***]

  
	
  FUNDED THROUGH:   [***]

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

  
	
   

  	
  [***]

  
	
   

  	
  [***]

  
	
   

  	
   

  
	
  15B.  CONTRACTOR/OFFEROR

  	
  15C.  DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

  
	
   

  	
   

  	
   

  	
  [***]

  
	
   

  	
   

  	
  BY

  	
  [***]

  	
   

  
	
  (Signature of person authorized to sign)

  	
   

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  
	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  	
  OMB
  No. 0990-0115

  	
  STANDARD
  FORM 30
  (REV. 10-83)

  
											

 

 

	
  Special Provisions

  	
  Contract No.
  N01-AI-30052

  	
  Page 2 of 2

  
	
   

  	
  Modification
  No. 01

  	
   

  

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE - paragraphs
d, e and g are modified to read as follows:

 

	
  d.

  	
  Total funds
  currently available for payment and allotted to this contract are increased
  by [***] from [***] to [***] 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 1.2. Authorized Substitutions of
  Clauses.

  
	
   

  	
   

  
	
  e.

  	
  It is
  estimated that the amount currently allotted will cover performance of the
  contract through [***].

  
	
   

  	
   

  
	
  g.

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

  

 

	
  FY

  	
   

  	
  PERIOD

  	
   

  	
  ESTIMATED COST

  	
   

  	
  FIXED FEE

  	
   

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

	
   

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

  
	
   

  	
   

  
	
   

  	
  No other
  terms and conditions are changed by this modification.

  

 

 

[Letterhead of Department of Health and Human Services]

 

August 9, 2004

 

	
  Our
  Reference:

  	
  Contract
  No. N01-AI-30052

  
	
   

  	
  Modifications
  03

  

 

Avecia Limited

PO Box 42, Hexagon House

Blackley

Manchester, M9 8ZS

England

 

[***]

 

[***]

 

We are enclosing an executed
copy of the referenced modification for your retention.  Should you have any questions regarding its
administration, please do not hesitate to contact me on (301) 402-6298 or write
to:

 

Contracting Officer

National Institute of Allergy
   and Infectious Diseases

National Institutes of Health

6700-B Rockledge Drive

Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

 

Sincerely,

 

 

[***]

 

[***]

Contracting Officer

Contract Management Branch

National Institute of Allergy
     and Infectious Diseases

 

 

	
  AMENDMENT
  OF SOLICITATION/MODIFICATION OF CONTRACT

  	
   

  	
  1. CONTRACT ID CODE

  	
   

  	
  PAGE OF PAGES

  
	
   

  	
   

  	
   

  	
   

  	
  1

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.
  AMENDMENT/MODIFICATION NO 

  	
  3.
  EFFECTIVE DATE

  	
   

  	
  4.
  REQUISITION/PURC 

  	
   

  	
  5.
  PROJECT NO. (if applicable) 

  
	
  03

  	
  See Block 16 C

  	
   

  	
  N/A

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6. ISSUED BY

  	
   

  	
  CODE

  	
   

  	
   

  	
   

  	
  7. ADMINISTERED BY (if other than Item 6)

  	
   

  	
  CODE

  	
           

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  Contract Management
  Branch, NIAID

  6700-B Rockledge Drive

  Room 2230, MSC 7612

  Bethesda, MD 20892-7612

  	
   

  	
   

  DMID - VRCB

  
	
   

  	
   

  	
   

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

  	
   

  	
  x

  	
   

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Avecia, Limited

  	
   

  	
   

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
  P.O. Box
  42 Hexagon House

  	
   

  	
   

  	
   

  	
   

  
	
  Blackleyh

  	
   

  	
  x

  	
   

  	
  10A. MODIFICATION OF
  CONTRACT/ ORDER NO.

  
	
  Manchester,
  M9 8ZS

  	
   

  	
   

  	
   

  	
  N01-AI-30052

  
	
  England

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  10B.
  DATED (SEE ITEM 13) 

  
	
   

  	
   

  	
   

  	
   

  	
  September 29, 2003

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CODE

  	
  FACILITY
  CODE

  	
   

  	
   

  	
   

  	
   

  
																						

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF
SOLICITATIONS

 

o 
The above numbered solicitation is amended as set forth in Item 14.  The hour and date specified for receipt of
Offers o is extended, o is
not extended.

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:  (a) By completing Items 8 and 15, and
returning                 
copies of the amendment; (b) By acknowledging receipt of this amendment on
each copy of the offer submitted; or (c) By separate letter or telegram
which includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR
AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this amendment, you desire to
change an offer already submitted, such change maybe made by telegram or
letter, provided each telegram or letter makes reference to the solicitation
and this amendment, and is received prior to the opening hour and date
specified.

 

12.  ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

 

13.  THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

	
  {PRIVATE}

  	
  A.    THIS CHANGE ORDER IS ISSUED PURSUANT
  TO:  (Specify
  authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE
  CONTRACT ORDER NO. IN ITEM 10A

  
	
   

  	
   

  
	
   

  	
  B.     THE ABOVE NUMBERED CONTRACT/ORDER IS
  MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as
  changes in paying office, appropriation date, etc.) SET FORTH IN
  ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)

  
	
   

  	
   

  
	
  x

  	
  C.     THIS SUPPLEMENTAL AGREEMENT IS ENTERED
  INTO PURSUANT TO THE AUTHORITY OF:

  FAR 1.602-1

  
	
   

  	
   

  
	
   

  	
  D.    OTHER (Specify type of
  modifications and authority)

   

  
	
  E.  IMPORTANT: 
  Contractor o is not, o is required to sign this document and return 2 copies to the issuing office.

  
	
  14. 
  DESCRIPTION OF AMENDMENT MODIFICATION (Organized
  by UCF section headings, including solicitation/contract subject matter where
  feasible)

   

  PURPOSE:  To
  modify ARTICLE G.1- PROJECT OFFICER and ARTICLE B.4 - ADVANCE UNDERSTANDINGS.

   

  Total Estimated Cost Plus Fixed Fee - [***]
  (Unchanged)

  Total Funds Allotted:  [***]
  (Unchanged)

   

  Completion Date:  [***] (Unchanged)

  Funded Through:  [***] (Unchanged)

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  
	
   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

   

  [***]

  	
  16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

  [***]

  [***]

  
	
   

  	
   

  
	
  15B.  CONTRACTOR/OFFEROR

   

  [***]

  	
   

  	
  15C. DATE SIGNED

   

  3August2004

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

   

   8/6/04

  
	
  BY

  	
  [***]

  
	
  (Signature of person authorized
  to sign)

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  
	
   

  
	
  NSN 7540-01-152-8070

  	
  OMB No. 9009-0115

  	
  STANDARD FORM 30 (REV. 10-83)

  FAR (48 CFR) 53.243

  
									

 

 

	
  {PRIVATE} Special Provisions

  	
  Contract No.
  N01-AI-30052

  	
  Page 2 of 3

  
	
   

  	
  Modification
  No. 03

  	
   

  

 

The
following name and address associated with the NIAID contracts organization are
modified where they appear in the contract:

 

	
  DELETE

  	
  REPLACE
  WITH

  
	
   

  	
   

  
	
  Contract
  Management Branch

  	
  Contract
  Management Program

  
	
  CMB,
  NIAID, NIH

  	
  CMP,
  NIAID, NIH

  
	
  Room 2230,
  MSC 7612

  	
  Room 3214,
  MSC 7612

  
	
  6700-B
  Rockledge Drive

  	
  6700-B
  Rockledge Drive

  
	
  Bethesda,
  MD 20892-7612

  	
  Bethesda,
  MD 20892-7612

  

 

ARTICLE
B.4. ADVANCE UNDERSTANDINGS paragraph p. is added to
the contract
as follows:

 

p.               The Centers for
Disease Control and Prevention (CDC) will supply the following to Avecia under
this contract as Government furnished information:

 

Current technical protocols
for:

 

[***]

 

The Center for Disease Control
will also supply uncontrolled copies of all associated quality system documents
for the proper implementation of these protocols.

 

CDC will initiate a separate
agreement with Avecia to transfer the above information.  The agreement will allow Avecia to share this
information with contractors that will be bidding [***].

 

When Avecia selects their
subcontractor, CDC may, pending further discussion and agreement with NIH,
provide public domain and proprietary computer software algorithms for the
implementation of these protocols, a limited quantity of reagents, and
technical or intellectual oversight for a technology transfer activity to the
successful subcontractor.

 

 

	
  {PRIVATE} Special Provisions

  	
  Contract No.
  N01-AI-30052

  	
  Page 3 of 3

  
	
   

  	
  Modification
  No. 03

  	
   

  

 

ARTICLE
G.1. PROJECT OFFICER is replaced in its entirety
with the following:

 

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

 

[***]

[***]

[***]

[***]

DHHS/NIH/NIAID

6610 Rockledge Dr, Room 5119, MSC 6604

Bethesda, MD 20892-6604

ph 301-451-4806

fax 301-480-1263

swinram@niaid.nih.gov

 

[***]

 

[***]

[***]

[***]

DHHS/NIH/NIAID

6610 Rockledge Dr, Room 5002, MSC 6604

Bethesda, MD 20892-6604

ph 301-451-6737

fax 301-480-1263

eflynn@niaid.nih.gov

 

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

 

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

 

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

 

The Government may unilaterally
change its Project Officer designation.

 

 

	
  AMENDMENT
  OF SOLICITATION/MODIFICATION OF CONTRACT

  	
   

  	
  1.

  	
  CONTRACT ID CODE

  	
   

  	
  PAGE OF PAGES

  
	
   

  	
   

  	
   

  	
  N/A

  	
   

  	
  1

  	
   

  	
  3

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

	
  2.  AMENDMENT/MODIFICATION NO.

  04

  	
  3.  EFFECTIVE DATE

  see block 16C, below

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  VRCB146

  	
  5.  PROJECT NO. (if
  applicable)

  
	
   

  	
   

  	
   

  	
   

  
	
  6.  ISSUED BY

  	
  CODE

  	
   

  	
  ADMINISTERED BY (if other than Item 6)

  VR

  	
  CODE

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  National Institute of
  Allergy and Infectious Diseases

  DEA, Contract Management
  Program

  Room 3214, MSC 7612

  6700-B Rockledge Drive

  Bethesda, MD 20892-7912

   

  	
   

  
	
  8.  NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP Code)

  	
  o

  	
  9A.  AMENDMENT OF SOLICITATION NO.

   

  
	
  Avecia Ltd

  P.O. Box 42,
  Hexagon House

  	
   

  	
  9B.  DATED (SEE ITEM 11)

   

  
	
  Blackley

  Manchester, M9 8ZS

  	
   

  	
  10A.  MODIFICATION OF CONTRACT/ORDER NO.

  N01-AI-30052

   

  
	
  England

  	
  x

  	
  10B.  DATED (SEE ITEM 13)

  
	
  CODE 

  	
  FACILITY CODE

  	
   

  	
  September 29, 2003

  
											

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF
SOLICITATIONS

 

o The above numbered solicitation is amended and set
forth in Item 14. The hour and date specified for receipt of Offers o is extended, o is
not extended.

 

Offers must acknowledge
receipt of this amendment prior to the hour and the specified in the
solicitation or as amended, by one of the following methods: 

 

(a) By completing
Items 8 and 15, and returning (1) copy of the amendment, (b) By
acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the solicitation
and amendment numbers.  FAILURE OF YOUR
ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS
PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR
OFFER.  If by virtue of this amendment
you desire to change an offer already submitted, such change may be made by
telegram or letter, provided each telegram or letter makes reference to the
solicitation and this amendment, and is received prior to the opening hour and
date specified.

 

12.  ACCOUNTING AND APPROPRIATION DATA (If required

EIN #1-900216013-A1            CAN #4-8460924 - [***]       SOC #25.55           [***]

 

13.  THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

	
  o

  	
  A.    THIS CHANGE ORDER IS ISSUED PURSUANT
  TO:  (Specify
  authority)  THE CHANGES
  SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

   

  
	
   

  	
  B.     THE ABOVE NUMBERED CONTRACT/ORDER IS
  MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as
  changes in paying office, appropriation date, etc.) SET FORTH IN
  ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

   

  
	
   

  	
  C.     THIS SUPPLEMENTAL AGREEMENT IS ENTERED
  INTO PURSUANT TO AUTHORITY OF:

   

  
	
  

  x

  	
  D.    OTHER (Specify type of
  modification and authority)

  Article B.2.f.

   

  
	
  E.  IMPORTANT: 
  Contractor  x is not, o is required to sign this document and return copies
  to the issuing office.

  
	
   

  
	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible.)

   

  PURPOSE: 
  To provide incremental funding and to update Section H. articles.

  

 

	
   

  	
  TOTAL FUNDS ALLOTTED

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  Estimated Cost

  	
   

  	
  Fixed Fee

  	
   

  	
  Total Allotted Amount

  	
   

  	
   

  
	
  Prior to this mod:

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  This modification #4:

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  Total:

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
   

  
	
  Total Funds Allotted:  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  TOTAL Contract
  Amount:  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Funded Through:  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Contract Completion
  Date:  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  
	
   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

  [***]

   

  
	
  15B.  CONTRACTOR/OFFEROR

  	
   

  	
  15C. DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  [***]

   

  	
  16C.  DATE SIGNED

  [***]

  
	
  BY

  	
   

  
	
  (Signature of person authorized
  to sign)

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  
	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  PREVIOUS EDITION
  UNUSABLE

  	
  30-105

  Computer Generated

  	
  STANDARD FORM 30
  (REV. 10-83)

  Prescribed by GSA

  FAR (40 CFR) 53.243

  
								

 

 

	
  SPECIAL PROVISIONS

  	
  CONTRACT
  No. N01-AI-30052

  	
  Page 2 of 3 Pages

  
	
   

  	
  Modification
  No. 4

  	
   

  

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE
- paragraphs d., e. and g. are hereby modified to read as follows:

 

d.              Total funds currently
available for payment and allotted to this contract are hereby increased by
[***] from [***] to [***]; of which [***] represents an increase to the
estimated cost from [***] to [***] and of which [***] represents an increase to
the fixed fee from [***] to [***].  For
further provisions on funding, see the LIMITATION OF FUNDS Clause referenced in
Part II, ARTICLE 1.2., Authorized Substitution of Clauses.

 

e.               It is estimated
that the amount currently allotted will cover performance of the contract
through [***].

 

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

 

	
  PERIOD

  	
   

  	
  ESTIMATED
  COST

  	
   

  	
  FIXED
  FEE

  	
   

  	
  TOTAL
  AMOUNT

  
	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  

 

ARTICLE
H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
- paragraph b. is hereby modified to add the following:

 

	
  b.

  	
   

  	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  P.L.
  108-199, Title V-General Provisions, Section 510

  	
   

  	
  2004

  	
   

  	
  10/01/2003
  -09/30/2004

  

 

ARTICLE H.7. 
NEEDLE EXCHANGE -  paragraph b. is hereby modified to add the
following:

 

	
  b.

  	
   

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  P.L.
  108-199, Title V-General Provisions, Section 505

  	
   

  	
  2004

  	
   

  	
  10/01/2003  09/30/2004

  

 

ARTICLE
H.12.  SALARY RATE LIMITATION
LEGISLATION PROVISIONS, paragraphs b and c are
hereby modified to add the following:

 

	
  b.

  	
   

  	
  Public Law. No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Dollar Amount of Salary
  Limitation

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  P.L.
  108-199, Title II - General Provisions, Section 204

  	
   

  	
  2004

  	
   

  	
  Executive
  Level I

  

 

c.               Direct salaries
which will be paid with FY-04 funds are limited to the Executive Level 1 rate
which was in effect on the date(s) the expense was incurred.

 

*For contract expenditures using FY-04 funds, the Executive Level I rate
for the period 10/1/03 - 12/31/03 is $171,900. 
Effective 1/1/04, for contract expenditures using FY-04 funds, the
Executive Level 1 rate was increased to $175,700 and will remain at that level
until such time as it is determined to raise the Executive Schedule annual
rates.  See the web site listed below for
Executive Schedule rates of pay.

 

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

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

 

	
  NOTE:

  	
  All
  prior Public Laws and related Executive Levels incorporated in the Basic
  Award and all previous Modifications shall remain in effect for the
  applicable fiscal year and related funds.

  

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. N01-AI-30052

  	
  Page 3 of 3 Pages

  
	
   

  	
  Modification
  No. 4

  	
   

  

 

ARTICLE H.14. 
PRESS RELEASES, paragraph b., is hereby
modified to add the following:

 

	
  b.

  	
   

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  P.L.
  108-199, Title V - General Provisions, Section 507

  	
   

  	
  2004

  	
   

  	
  10/01/2003-09/30/2004

  

 

ARTICLE
H.16.  ANTI-LOBBYING,
paragraph c. is hereby modified to add the following:

 

	
  a.

  	
   

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

  
	
   

  	
   

  	
   

  
	
  b.

  	
   

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

  

 

	
  c.

  	
   

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  for a.
  above:

  P.L. 108-199, Title V - General Provisions, Section 503a

  	
   

  	
  2004

  	
   

  	
  10/01/2003 -
  09/30/2004

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  for b.
  above:

  P.L. 108-199, Title V - General Provisions, Section 503b

  	
   

  	
  2004

  	
   

  	
  10/01/2003 -
  09/30/2004

  

 

	
   

  	
   

  	
  All
  other terms and conditions of the contract remain unchanged.

  

 

 

	
  AMENDMENT OF
  SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  	
  PAGE OF PAGES

  
	
   

  	
   

  	
  1

  	
  8

  
	
   

  	
   

  	
   

  	
   

  
	
  2.  AMENDMENT /MODIFICATION NO

  Mod #06

  	
  3.  EFFECTIVE DATE

  See Block 16 C

  	
  4.  REQUISITION/PURC

  N/A

  	
  5.  PROJECT NO. (If applicable)

  N/A

  
	
   

  	
   

  	
   

  	
   

  
	
  6.  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other than Item 6)

  	
  CODE

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  	
   

  
	
  Contract Management
  Program, NIAID

  	
   

  
	
  6700-B Rockledge Drive 

  	
   

  
	
  Room 3214, MSC 7612

  	
   

  
	
  Bethesda, MD 20892-7612

  	
   

  
	
   

  	
   

  
	
  8.  NAME AND ADDRESS OF CONTRACTOR (No., street,
  county, State and Zip Code)

  	
  x

  	
  9A.  AMENDMENT OF SOLICITATION NO.

  
	
   

  	
   

  	
   

  
	
   

  	
  Avecia Limited

  	
   

  	
  9.B.  DATED (SEE ITEM 11)

  
	
   

  	
  P.O. Box 42,
  Hexagon House

  	
   

  	
   

  
	
   

  	
  Blackley, Manchester, M9
  8ZS, UK

  	
   

  	
   

  
	
   

  	
  x

  	
  10A.  MODIFICATION PF CONTRACT/ORDER NO.

  
	
   

  	
   

  	
  N01-AI-30052

   

  
	
   

  	
   

  	
  10B.  DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
   

  	
  September 29, 2003

  
														

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF
SOLICITATIONS

 

“ The above numbered
solicitation is amended as set forth in item 14.  The hour and date specified for receipt of
offers” is extended. “  is not extended.

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:  (a) By completing items 8 and 15, and
returning                  
copies of the amendment:  (b) By
acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the
solicitation and amendment numbers. 
FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER.  If by virtue of
this amendment, you desire to change an offer already submitted, such change
may be made by telegram or letter, provided each telegram or letter makes
reference to the solicitation and this amendment, and is received prior to the
opening hour and date specified.

 

12.  ACCOUNTING AND APPROPRIATION DATA (If
required)

 

13.  THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
CONTRACTS/ORDERS.  IT MODIFIES THE
CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

	
  x  

  	
  A.

  	
  THIS CHANGE ORDER IS
  ISSUED PURSUANT TO:  (Specify
  authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER
  NO. IN ITEM 10A.

  
	
  x

  	
  FAR 43.202

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  B.

  	
  THE ABOVE NUMBERED
  CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.)
  SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

  
	
   

  	
   

  	
   

  
	
   

  	
  C.

  	
  THIS SUPPLEMENTAL
  AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: FAR 1.602-1 AND 52.243-2,
  Changes - Cost Reimbursement, Alternate V

  
	
   

  	
   

  	
   

  
	
   

  	
  D.

  	
  OTHER (Specify type of modification and authority)

  
	
   

  	
   

  
	
  E.  IMPORTANT: 
  Contractor o is not, x is required to sign this document and return 3 copies
  to the issuing office

  
	
   

  
	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
   

  
	
  PURPOSE:  To issue a Change Order to the Statement of
  Work and revise the milestone payment schedule in Article B.4.

  
	
   

  
	
  TOTAL AMOUNT
  FUNDED:  [***]

  
	
  TOTAL ESTIMATED
  COST:  [***]

  
	
  FUNDED THROUGH:  [***]

  
	
  CONTRACT EXPIRATION
  DATE:  [***]

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changes, remains unchanges and in  full force and effect

  
	
   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or Print)

  	
  16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

  
	
   [***]

  	
   

  
	
   

  	
   

  
	
  15B. CONTRACTOR/OFFEROR

  	
  15C.  DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

  
	
   [***]

  	
        27JUL05

  	
   [***]

   [***]

   

  	
  [***]

  
	
  [***]

  	
   

  	
  BY

  	
  [***]

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
  (Signature
  of contracting Officer)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  	
  OMB No. 0990-0115

  	
  STANDARD FORM 30 (REV. 10-83)

  Far (48 CFR) 53.243

  
										

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 2 of pages 8

  
	
   

  	
  Modifications
  No. 6

  	
   

  

 

ARTICLE B.4.  ADVANCE UNDERSTANDINGS
- Paragraph h., item 17 is deleted, and items 4-8, and 10-16 are hereby revised
as follows:

 

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 shall be
determined by the Project Officer’s written certification that the milestone
has been satisfactorily performed and that the technical requirements have been
met regarding the completion of the following milestones:  If the Contractor meets the milestones
earlier than the dates set forth below, then the fee will be paid at the
earlier date after completion of the milestone.

 

	
   

  	
   

  	
  MILESTONES FOR AVECIA

  	
   

  	
  ESTIMATED COST

  	
   

  	
  FIXED FEE

  	
   

  	
  TOTAL CPFF

  
	
  4

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in two installments for this milestone based on the
  completion of the following items:

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in three installments for this milestone based on
  the completion of the following items:

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 3 of pages 8

  
	
   

  	
  Modification
  No. 6

  	
   

  

 

	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in six installments for this milestone based on the
  completion of the following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 4 of pages 8

  
	
   

  	
  Modification
  No. 6

  	
   

  

 

	
  10

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in three installments for this milestone based on
  the completion of the following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  11

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
  Fee shall be paid in three installments for this milestone based on
  the completion of the following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 5 of pages 8

  
	
   

  	
  Modification
  No. 6

  	
   

  

 

	
  12

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in two installments for this milestone based on the
  completion of the following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in six installments for this milestone based on the
  completion of the following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in three yearly installments for this milestone
  based on the completion of the following

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 6 of pages 8

  
	
   

  	
  Modification
  No. 6

  	
   

  

 

	
   

  	
   

  	
  items:

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  15

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in three equal installments (one each

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  year) on provision of [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be paid in three installments (one each

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
  year) upon completion of [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 7 of pages 8

  
	
   

  	
  Modification
  No. 6

  	
   

  

 

ARTICLE
B.4.  ADVANCE UNDERSTANDINGS
- Paragraph p., is added to read as follows:

 

p.  Contractor’s Statement of
Release

 

In consideration of the modification agreed to herein as complete
equitable adjustments for the Contractor’s doses reduction proposal for
adjustment, the Contractor hereby releases the Government from any and all
liability under this contract for further equitable adjustments attributable to
such facts or circumstances giving rise to the proposal for adjustment.

 

ARTICLE
G.1.  PROJECT OFFICER
- the second paragraph is hereby modified to replace the Co-Project Officer as
follows:

 

[***]

[***]

[***]

[***]

DHHS/NIH/NIAID/OBRA

Bethesda MD 20892

Ph:  (301) 451-6737

Fax:  (301) 480-1263/ (301) 480-3235

shrivass@niaid.nih.gov

 

SECTION J
- List of Attachments

 

ATTACHMENT
1, Statement of Work, Milestones 4-6, 8, 10-14, and 17
are hereby modified as follows:

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

	
  SPECIAL
  PROVISIONS

  	
  CONTRACT
  No. HHSN26620030052C

  	
  Page 8 of pages 8

  
	
   

  	
  Modification
  No. 6

  	
   

  

 

[***]

 

[***]

 

[***]

 

[***]

 

Milestone
17:  DELETED.*

 

[***]

 

All other terms and conditions of the
contract remain unchanged.

 

 

[Letterhead of Department of Health and Human Services]

 

September 13, 2005

 

[***]

Avecia Limited

P.O. Box 42, Hexagon House

Blackley, Manchester, M9 8ZS, UK

 

	
  Subject:

  	
   

  	
  Contract No. N01-AI-30052

  
	
   

  	
   

  	
  Modification
  No. 07

  

 

[***]

 

We are enclosing an executed
copy of the subject modification for your retention. If you have any questions
regarding its administration, please contact the Undersigned, at (301)
451-2617.

 

Sincerely,

 

[***]

[***]

Contract Specialist

 

 

	
  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  N/A

  	
  PAGE OF PAGES

  
	
  1

  	
  3

  
	
   

  	
   

  	
   

  	
   

  
	
  2.  AMENDMENT/MODIFICATION NO.

  07

  	
  3.  EFFECTIVE DATE

  [See block 16C, below]

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  DMID 2 017

  	
  5.  PROJECT NO. (If
  applicable)

  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  National Institute of
  Allergy and Infectious Diseases

  DEA, Contract Management
  Branch

  Room 3214, MSC 7612

  6700-B Rockledge Drive

  Bethesda, MD 20892-7612

  	
  MID2-RCB

  
	
   

  
	
   

  	
   

  	
   

  
	
  8. NAME AND ADDRESS OF
  CONTRACTOR (No., street, country, State and ZIP Code)

  	
  x

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  
	
  Avacia Limited

  P.O. Box 42,
  Hexagon House

  Blackley, Manchester, M9
  8ZS, UK

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
											

 

	
   

  	
   

  	
  x

  	
  10A.
  MODIFICATION OF CONTRACT/ORDER NO.

  
	
   

  	
   

  	
   

  	
  NO1-AI-30052

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  10B.
  DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
   

  	
  09/30/2003

  

 

11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS

 

o 
The above numbered solicitation is amended as set forth in Item 14.  The hour and date specified for receipt of
Offers o is extended, o is
not extended.

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:  (a) By completing Items 8 and 15, and
returning
              
copies of the amendment; (b) By acknowledging receipt of this amendment on
each copy of the offer submitted; or (c) By separate letter or telegram
which includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR
AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this amendment, you desire to
change an offer already submitted, such change may be made by telegram or
letter, provided each telegram or letter makes references to the solicitation
and this amendment, and is received prior to the opening hour and date
specified.

 

12. ACCOUNTING AND
APPROPRIATION DATA (If required)

DOC#300N1AI30052A           EIN 
1-900216013-A1            CAN  3-8460924     SOCC#
25.55           [***]

 

13. THIS ITEM APPLIES ONLY TO
MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS
DESCRIBED IN ITEM 14.

 

	
   

  	
  A.

  	
  THIS
  CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

  
	
   

  	
   

  	
   

  
	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation
  date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

  
	
   

  	
   

  	
   

  
	
   

  	
  C.

  	
  THIS SUPPLEMENTAL
  AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  
	
   

  	
   

  	
   

  
	
  x

  	
  D.

  	
  OTHER (Specify type of modification and authority)

  P.L. 1.602-1; Limitation
  of Funds Clause and P.L. 108-447

   

  
	
  E.             IMPORTANT:  Contractor x is not, o is required to sign this document and
  return              
  copies to the issuing office.

   

  
	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE: 
  Incremental Funding.

  

 

	
   

  	
   

  	
  Total
  Funds Currently Allotted

  	
   

  	
  Total
  Estimated Cost

  	
   

  
	
   

  	
   

  	
  Cost

  	
   

  	
  Fixed
  Fee

  	
   

  	
  CPFF

  	
   

  	
  Cost

  	
   

  	
  Fixed
  Fee

  	
   

  	
  CPFF

  	
   

  
	
  Total Prior to
  this Mod:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  Mod #01:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  Revised TOTAL

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  COMPLETION DATE:
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  FUNDED THROUGH:
  [***]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  
	
   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

    [***]

    [***]

  
	
   

  	
   

  	
   

  	
   

  
	
  15B.  CONTRACTOR/OFFEROR

  	
  15C.  DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
                  [***]

  
	
   

  	
   

  	
   

  	
  BY

  	
  [***]

  	
   

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
  (Signature of Contracting
  Officer)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  PREVIOUS EDITION
  UNUSABLE

  	
  30-105

  Computer Generated

  	
  STANDARD FORM 30 (REV.
  10-83)STANDARD
  FORM 30 (REV. 10-83  Prescribed by
  GSA

  FAR (48 CFR) 53.243

  
										

 

 

	
  CONTRACT No. N01-AI-30052

  	
  SPECIAL
  PROVISIONS

  	
  Page 2 of 3

  
	
  Modification No. 07

  

 

ARTICLE B.2. 
ESTIMATED COST AND FIXED FEE, paragraphs d. and e., are hereby modified to read as
follows and paragraph g. is deleted in its entirety:

 

d.                                      Total funds currently available for
payment and allotted to this contract are hereby increased by [***] from [***]
to [***];  of which [***] represents an
increase to the estimated cost from [***] to [***];  and  of
which [***] represents an increase to the fixed fee from  [***] to 
[***].  For further provisions on
funding, see the LIMITATION OF COST Clause referenced in Part II, ARTICLE
1.1., General Clauses for a Cost-Reimbursement Research and Development
Contract.

 

e.                                       It is estimated that the amount currently
allotted will cover performance of the contract through [***]. By virtue of
this action, this contract is hereby fully funded.

 

ARTICLE H.6. 
CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH, paragraph b. is hereby modified to add
the following:

 

	
  b.

  	
  Public
  Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 108-447,
  Title V General Provisions, Section 509

  	
   

  	
  2005

  	
   

  	
  10/01/04-09/30/05

  	
   

  

 

ARTICLE H.7. 
NEEDLE EXCHANGE, paragraph b, is hereby modified to add the
following:

 

	
  b.

  	
  Public
  Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 108-447,
  Title V - General Provisions, Section 505

  	
   

  	
  2005

  	
   

  	
  10/01/04-09/30/05

  	
   

  

 

ARTICLE H.12. 
SALARY RATE LIMITATION LEGISLATION PROVISIONS, paragraphs b. and c. are hereby
modified to add the following:

 

	
  b.

  	
  Public
  Law No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Dollar
  Amount of

  Salary Limitation*

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  108-447.  Title II, General Provisions,
  Section 204

  	
   

  	
  2005

  	
   

  	
  Executive Level I

  	
   

  

 

c.                                       Direct salaries are limited to the
Executive Level I rate which was in effect on the date(s) the expense was
incurred.

 

*For the period 10/1/04-12/31/04,
the Executive Level I rate is $175,700. Effective 1/1/05, the Executive Level I
rate increased to $180,100 and will remain at that rate until it is revised.
See the web site listed below for Executive Schedule rates of pay.

 

LINK
to EXECUTIVE LEVEL SALARIES:  http://www.opm.gove/oca/05tables/html/ex.asp (For previous years, go to:  http://www.opm.gove/oca/05tables/index.asp
and click on the year to locate the Executive Level salary rates.)

 

	
  NOTE:

  	
  All prior Public Laws and related Executive Levels
  incorporated in the Basic Award and all previous Modifications shall remain
  in effect for the applicable fiscal year and related funds.

  

 

HHS-556

 

 

	
  CONTRACT No. N01-AI-30052

  	
  SPECIAL
  PROVISIONS

  	
  Page 3 of 3

  
	
  Modification No. 07

  

 

ARTICLE H.14. 
PRESS RELEASES, paragraph b., is hereby modified to add the
following:

 

	
  b.

  	
  Public
  Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 108-447,
  Title V - General Provisions, Section 506

  	
   

  	
  2005

  	
   

  	
  10/01/04-09/30/05

  	
   

  

 

ARTICLE H.16. 
ANTI-LOBBYING, paragraph c., is hereby modified to add the
following:

 

	
  c.

  	
  Public
  Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  for b., above:  P.L. 108-447, Title V - General Provisions,
  Section 503b

  	
   

  	
  2005

  	
   

  	
  10/1/04-9/30/05

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  for
  a., above:  P.L. 108-447, Title V -
  General Provisions, Section 503a

  	
   

  	
  2005

  	
   

  	
  10/1/04-9/30/05

  	
   

  

 

ARTICLE I.2. 
AUTHORIZED SUBSTITUTION OF CLAUSES, is hereby modified to delete FAR Clause 52.232-22,
LIMITATION OF FUNDS (APRIL 1984), reinstating the applicability of FAR Clause
52.232-20, LIMITATION OF COST (APRIL 1984) of ARTICLE 1.1.

 

HHS-556

 

 

	
  AMENDMENT OF
  SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  N/A

  	
  PAGE OF PAGES

  
	
  1

  	
  4

   

  
	
  2.  AMENDMENT/MODIFICATION NO

  	
  3.

  	
  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  	
  5.  PROJECT NO. (If applicable)

  
	
  08

  	
   

  	
  [See
  block 16C, below]

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  
	
  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
  N/A

  
	
   

  National Institutes of
  Health

  National Institute of
  Allergy and Infectious Diseases

  DEA, Contract Management
  Branch

  Room 3214, MSC 7612

  6700-B Rockledge Drive

  Bethesda, MD 20892-7612

   

  	
  MID-RCB-B

  
	
   

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

  	
  x

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  
	
  Avacia Limited

  PO Box 42, Hexagon House

  Blackley, Manchester, M9
  8ZS, UK

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
   

  	
  x

  	
  10A.
  MODIFICATION OF CONTRACT/ORDER NO.

  
	
   

  	
  N01-AI-30052

   

  
	
   

  	
  10B. DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
  09/30/2003

  
												

 

11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is
amended as set forth in Item 14.  The
hour and date specified for receipt of Offers o is
extended, ois not extended.

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:  (a) By completing Items 8 and 15, and
returning
             copies
of the amendment; (b) By acknowledging receipt of this amendment on each
copy of the offer submitted; or (c) By separate letter or telegram which
includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR
AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this amendment, you desire to
change an offer already submitted, such change may be made by telegram or
letter, provided each telegram or letter makes references to the solicitation
and this amendment, and is received prior to the opening hour and date
specified.

 

12. ACCOUNTING AND
APPROPRIATION DATA (If required)

EIN  1-900216013-A1    SOCC#
25.55               CAN 
6-846701                                    [***]

 

13. THIS ITEM APPLIES ONLY TO
MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS
DESCRIBED IN ITEM 14.

 

	
   

  	
  A.

  	
  THIS CHANGE
  ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

   

  
	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation
  date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

   

  
	
   

  	
  C.

  	
  THIS
  SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  
	
  x

  	
  D.

  	
  OTHER
  (Specify type of modification and authority)

  P.L.
  1.602-1; Limitation of Cost Clause and P.L. 109-149

   

  
	
  E.           IMPORTANT:  Contractor o is not, x is required to sign this document and
  return 2 copies to the issuing office.

   

  
	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE: 
  To increase the Total Estimated Cost of the contract and obligate
  funds in the amount of the increase.

  

 

	
   

  	
   

  	
  Total
  Funds Currently Allotted

  	
   

  	
  Total
  Estimated Cost

  	
   

  
	
   

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  
	
  Total Prior to this Mod:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  This Mod #

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  Revised Total

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

	
  COMPLETION DATE:  [***]

  
	
  FUNDED THROUGH:  [***]

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

  
	
  [***]

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  15B.  CONTRACTOR/OFFEROR

  	
  15C.  DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

  
	
  [***]

  	
  30 August 2006

  	
  [***]

   

  	
  [***]

  
	
   

  	
   

  	
  BY

  	
   

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  
	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  PREVIOUS EDITION UNUSABLE 

  	
  30-105

  Computer
  Generated

  	
  STANDARD FORM 30 (REV.
  10-83

  Prescribed by GSA

  FAR (48 CFR)
  53.243

  
						

 

 

	
  CONTRACT No: N01-AI-30052

  	
  SPECIAL PROVISIONS

  	
  Page 2 of 4

  
	
  Modification No: 08

  

 

ARTICLE
B.2.  ESTIMATED COST AND FIXED FEE,
paragraphs a., c., d., and e., are hereby modified to read as follows:

 

	
  a.

  	
   

  	
  The
  estimated cost of this contract is increased by [***] from [***] to [***].

  
	
   

  	
   

  	
   

  
	
  c.

  	
   

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

  
	
   

  	
   

  	
   

  
	
  d.

  	
   

  	
  Total funds
  currently available for payment and allotted to this contract are hereby
  increased by [***] from [***] to [***]; of which [***] represents an increase
  to the estimated cost from [***] to [***] and of which [***] represents and
  increase to the fixed fee remaining unchanged at [***] For further provisions
  on funding, see the LIMITATION OF COST Clause referenced in Part II,
  ARTICLE 1.1., General Clauses for a Cost-Reimbursement Research and
  Development Contract.

  
	
   

  	
   

  	
   

  
	
  e.

  	
   

  	
  It is
  estimated that the amount currently allotted will cover performance through
  contract completion.

  

 

ARTICLE
B.3.  ADVANCE UNDERSTANDINGS,
paragraphs h., is hereby modified to revise the submilestone estimated cost,
fixed fee and total cost plus fixed fee detail as follows (all other aspect and
descriptions of the milestone chart remains inchanged):

 

	
  Milestone

  	
   

  	
  Submilestone

  	
   

  	
  Estimated

  Cost

  	
   

  	
  Fixed

  Fee

  	
   

  	
  Total

  CPFF

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
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  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
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HHS-556

 

 

	
  CONTRACT No: N01-AI-30052

  	
  SPECIAL PROVISIONS

  	
  Page 3 of pages 4

  
	
  Modification No: 08

  

 

	
   

  	
   

  	
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HHS-556

 

 

	
  CONTRACT No: N01-AI-30052

  	
  SPECIAL PROVISIONS

  	
  Page 4 of pages 4

  
	
  Modification No: 08

  	
   

  	
   

  

 

ARTICLE H.6. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH,
paragraph b. is hereby modified to add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 109-149, Title V - General Provisions, Section 509

  	
   

  	
  2006

  	
   

  	
  10/01/05-09/30/06

  	
   

  

 

ARTICLE H.7.  NEEDLE EXCHANGE, paragraph b. is hereby modified to
add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 109-149, Title V - General Provisions, Section 505

  	
   

  	
  2006

  	
   

  	
  10/01/05-09/30/06

  	
   

  

 

ARTICLE H.12. SALARY RATE LIMITATION LEGISLATION PROVISIONS,
paragraphs b. and c. are hereby modified to add the following:

 

	
  b.

  	
  Public Law No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Dollar Amount of Salary Limitation*

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 109-149

  	
   

  	
  2006

  	
   

  	
  Executive Level I

  	
   

  

 

	
  c.

  	
   

  	
  Payment of
  direct salaries is limited to the Executive Level I* rate which was in effect
  on the date(s) the expense was incurred.

  

 

	
  *

  	
  For the
  period 10/1/05 - 12/31/05, the Executive Level I rate is $180,100. Effective
  January 1, 2006, the Executive Level I rate increased to $183,500 and
  will remain at that rate until it is revised. See the web site listed below
  for the Executive Schedule rates of pay:

  

 

FOR FY06 EXECUTIVE LEVEL SALARIES EFFECTIVE JANUARY 1, 2006:

 

http://www.opm.gove/oca/06tables/html/ex.asp

 

(Note:  This
site shows the FY-06 rates. For previous years, click on “salaries and wages”
and then scroll down to the bottom of the page and click on the year to
locate the desired Executive Level salary rates.)

 

NOTE:        All prior Public Laws and
related Executive Levels incorporated in the Basic Award and all previous
Modifications shall remain in effect for the applicable fiscal year and related
funds.

 

ARTICLE H.14. PRESS RELEASES, paragraph b., is
hereby modified to add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 109-149, Title V - General Provisions, Section 506

  	
   

  	
  2006

  	
   

  	
  10/01/05-09/30/06

  	
   

  

 

ARTICLE H.16. ANTI-LOBBYING, paragraph c., is
hereby modified to add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L. 109-149, Title V - General Provisions, Section 503a

  	
   

  	
  2006

  	
   

  	
  10/01/05-09/30/06

  	
   

  
	
   

  	
  P.L. 109-149, Title V - General Provisions, Section 503b

  	
   

  	
  2006

  	
   

  	
  10/01/05-09/30/06

  	
   

  

 

HHS-556

 

 

	
  AMENDMENT OF
  SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  N/A

  	
  PAGE OF PAGES

  
	
  1

  	
  2

   

  
	
  2.  AMENDMENT/MODIFICATION NO

  	
  3.  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  	
  5.  PROJECT NO. (If applicable)

  
	
  09

  	
  [See block 16C, below]

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  
	
  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
      N/A

  
	
   

  National Institutes of
  Health, HHS

  National Institute of
  Allergy and Infectious Diseases

  DEA, Contract Management
  Branch

  6700-B Rockledge Drive

  Room 3214, MSC 7612

  Bethesda, MD 20892-7612

   

  	
  MID RCB-B

  
	
   

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

  	
  x

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  
	
  Avacia Limited

  PO Box 42, Hexagon House

  Blackley, Manchester, M9
  8ZS, UK

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
   

  	
  x

  	
  10A.
  MODIFICATION OF CONTRACT/ORDER NO.

  
	
   

  	
  N01-AI-30052

   

  
	
   

  	
  10B. DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
  09/30/2003

  
											

 

11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is
amended as set forth in Item 14.  The
hour and date specified for receipt of Offers o is
extended, o is not extended.

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:  (a) By completing Items 8 and 15, and
returning copies of the amendment; (b) By acknowledging receipt of this
amendment on each copy of the offer submitted; or (c) By separate letter
or telegram which includes a reference to the solicitation and amendment
numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT
TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE
HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this amendment, you desire to
change an offer already submitted, such change may be made by telegram or
letter, provided each telegram or letter makes references to the solicitation
and this amendment, and is received prior to the opening hour and date
specified.

 

12. ACCOUNTING AND
APPROPRIATION DATA (If required)

EIN  1-900216013-A1; SOCC 25-55

 

13. THIS ITEM APPLIES ONLY TO
MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS
DESCRIBED IN ITEM 14.

 

	
   

  	
  A.

  	
  THIS
  CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

   

  
	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation
  date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

   

  
	
   

  	
  C.

  	
  THIS
  SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  
	
  x

  	
  D.

  	
  OTHER
  (Specify type of modification and authority)

  P.L.
  1.602-1; Limitation of Cost Clause and P.L. 109-149

   

  
	
  E.         IMPORTANT:  Contractor o is not, x is required to sign this document and
  return 2 copies to the issuing office.

   

  
	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE:  Modify Invoice Payment Procedures under
  ARTICLE G.3.

   

  
	
  COMPLETION DATE:  [***]

  	
  FUNDED THROUGH:  [***]

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

  
	
  [***]

  	
  [***]

  
	
  [***]

  	
  [***]

  
	
   

  	
   

  
	
  15B.  CONTRACTOR/OFFEROR

  	
  15C.  DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

  
	
  [***]

  	
  14JUN07

  	
  [***]

   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  BY

  	
   

  	
   

  
	
  (Signature of person authorized to sign)

  	
   

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  
	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  PREVIOUS EDITION UNUSABLE 

  	
  30-105

  Computer
  Generated

  	
  STANDARD FORM 30 (REV.
  10-83

  Prescribed by GSA

  FAR (48 CFR)
  53.243

  
									

 

 

	
  CONTRACT
  No. N01-AI-30052

  	
  SPECIAL PROVISIONS

  	
  Page 2 of 2

  
	
  Modification
  No. 9

  

 

ARTICLE
G.3.      INVOICE SUBMISSION/CONTRACT
FINANCING REQUEST AND CONTRACT FINANCIAL REPORT - is hereby modified to read as
follows:

 

	
  a.

  	
   

  	
  Invoice/Financing
  Request Instructions and Contract Financial Reporting for NIH
  Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of
  this contract. The Contractor shall follow the attached instructions and
  submission procedures specified below to meet the requirements of a “proper
  invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (1)

  	
  Payment
  requests shall be submitted as follows:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  On original to follow designated billing
  office:

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  National
  Institutes of Health

  
	
   

  	
   

  	
   

  	
   

  	
  Office of
  Financial Management

  
	
   

  	
   

  	
   

  	
   

  	
  Commercial
  Accounts

  
	
   

  	
   

  	
   

  	
   

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

  
	
   

  	
   

  	
   

  	
   

  	
  Bethesda, MD
  20892-8500

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  (2)

  	
  In addition
  to the requirements specified in FAR Subpart 32.9 for a proper invoice, the
  Contractor shall include the following information on all payment request:

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (a)

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

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (b)

  	
  Central
  Point of Distribution. For the purpose of this contract, the Central Point of
  Distribution is NIAID  OA  Invoices.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (c)

  	
  Vendor
  Identification Number. This is the 7 digit number that appears after the
  Contractors name in Block 7 of Standard Form 26. (Note: This
  only applies to new contracts awarded on/after June 4, 2007, and any
  existing contract modified to include the number.)

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (d)

  	
  DUNS number
  or DUNS+4 that identifies the Contractor’s name and address exactly as stated
  on the face page of the contract.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
  (e)

  	
  Identification
  of whether payment is to be made using a two-way or three-way match. This
  contract requires a two-way
  match.

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  b.

  	
   

  	
  Inquiries
  regarding payment shall be directed to the designated billing office, (301)
  496-6088.

  

 

SECTION J
- Attachment 2, Invoice/Financing Request Instructions and Contract Financial
Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 is hereby
replaced with the following updated attachment.

 

HHS-556

 

 

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

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

 

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

 

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

 

Frequency: 
Payment requests shall not be submitted more frequently than once every
two weeks in accordance with the Allowable Cost and Payment Clause incorporated
into this contract. Small business concerns may submit invoices/financing
requests more frequently than every two weeks when authorized by the
Contracting Officer.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Preparation and Itemization
of the Invoice/Financing Request:  The Contractor shall furnish
the information set forth in the instructions below. The instructions are keyed
to the entries on the Sample Invoice/Financing request.

 

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

 

(b)                                 Contractor’s Name, Address, Point of contact, VIN, and DUNS or DUNS+4
Number:  Show the Contractor’s name and address
exactly as they appear in the contract, along with the name, title, 

 

	
  NIH(RC)-4

  	
   

  	
  ATTACHMENT 2

  
	
  Rev. 05/2007

  	
   

  	
  Page 1

  

 

 

phone number, and e-mail
address of the person to notify in the event of an improper invoice or, in the
case of payment by method other than Electronic Funds Transfer, to whom payment
is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and
Data Universal Numbering System (DUNS) number or DUNS+4.  The DUNS number must identify the Contractor’s
name and address exactly as stated on the face page of the contract. When
an approved assignment has been made by the Contractor, or a different payee
has been designated, provide the same information for the payee as is required
for the Contractor (i.e., name, address, point of contract, VIN, and DUNS).

 

(c)                                  Invoice/financing Request Number:  Insert the appropriate serial
number of the payment request.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

	
  NIH(RC)-4

  	
   

  	
  ATTACHMENT 2

  
	
  Rev. 05/2007

  	
   

  	
  Page 2

  

 

 

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

 

(2)                                  Fringe Benefits:  List any fringe benefits applicable to direct
labor and billed as a direct cost. Do not include in this category fringe
benefits that are included in indirect costs.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(6)                                  Consultant Fee:  List fees paid to consultants. Identify
consultant by name or category as set for in the contract or COA, as well as
the effort (i.e., number of hours, days, etc.) and rate billed.

 

(7)                                  Travel:  Include domestic and foreign travel. Foreign
travel is travel outside of Canada, the United States and its territories and
possessions, foreign travel means travel outside that country. Foreign travel
must be billed separately from domestic travel.

 

(8)                                  Subcontract Costs:  List subcontractor(s) by name and amount
billed.

 

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

 

(p)                                 Cost of Money (COM):  Cite the COM factor and base in effect during
the time the cost was incurred and for which reimbursement is claimed.

 

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

 

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

 

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

 

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

 

	
  NIH(RC)-4

  	
   

  	
  ATTACHMENT 2

  
	
  Rev. 05/2007

  	
   

  	
  Page 3

  

 

 

(u)                                 Grand Totals

 

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

 

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

 

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

 

FINANCIAL REPORTING INSTRUCTIONS:

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

	
  NIH(RC)-4

  	
   

  	
  ATTACHMENT 2

  
	
  Rev. 05/2007

  	
   

  	
  Page 4

  

 

 

SAMPLE
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

(a)          Designated
Billing Office Name and Address:

 

National Institutes of Health

Office of Financial Management

Commercial Accounts

2115 East Jefferson Street, Room 4B432, MSC 8500 

Bethesda, MD 20692-8500

 

(b)          Contractor’s
Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:

 

ABC CORPORATION

100 Main Street

Anywhere, USA Zip Code

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

VIN:

DUNS or DUNS+4

(c)                                  Invoice/Financing
Request No.:

 

(d)                                 Date
Invoice Prepared:

 

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

 

(f)                                    Effective
Date:

 

(g)                                 Total
Estimated Cost of Contract/Order:

 

(h)                                 Total
Fixed-Fee (if applicable):

 

(i)                                     o
Two-Way Match o Three-Way Match

 

(j)                                     Office
of Acquisitions:

 

(k)                                  Central
Point of Distribution:

 

(l)                                     This
invoice /financing request represents reimbursable costs for the period               
to                

 

	
   

  	
   

  	
  Cumulative Percentage of

  	
   

  	
  Amount Billed

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Effort/Hrs

  	
   

  	
   

  	
   

  	
  (n)

  	
   

  	
  Cost at

  	
   

  	
  Contract

  	
   

  	
   

  	
   

  
	
  Expenditure Category*

  	
   

  	
  Negotiated

  	
   

  	
  Actual

  	
   

  	
  (m) Current

  	
   

  	
  Cumulative

  	
   

  	
  Completion

  	
   

  	
  Amount

  	
   

  	
  Variance

  	
   

  
	
  A

  	
   

  	
  B

  	
   

  	
  C

  	
   

  	
  D

  	
   

  	
  E

  	
   

  	
  F

  	
   

  	
  G

  	
   

  	
  H

  	
   

  
	
  (o) Direct Costs:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (1) Direct Labor

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (2) Fringe Benefits

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (3) Accountable Property

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (4) Materials and Supplies

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (5) Premium Pay

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (6) Consultant Fees

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (7) Travel

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (8) Subcontracts

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (9) Other

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total Direct Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (p) Cost of Money

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (q) Indirect Costs

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (r) Fixed Fee

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (s) adjustments

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (t) adjustments

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (u) 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

 

	
  NIH(RC)-4

  	
   

  	
  ATTACHMENT 2

  
	
  Rev. 05/2007

  	
   

  	
  Page 5

  

 

 

	
  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  N/A

  	
  PAGE OF PAGES

  
	
  1

  	
  8

  

 

	
  2.  AMENDMENT/MODIFICATION NO

  	
  3.  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  	
  5.  PROJECT NO. (If applicable)

  
	
  10

  	
  [see block 16C, below]

  	
  DMIO 2 017

  	
  N/A

  

 

	
  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  National Institute of Allergy and Infectious Diseases

  DEA, Contract Management Branch

  Room 3214 MSC 7612

  6700-B Rockledge Drive

  Bethesda, MD 20892-7612

  	
  MID2-RCB

  
	
   

  

 

	
  8. NAME AND ADDRESS OF
  CONTRACTOR (No., Street, county, State and ZIP Code)

  	
  o

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  
	
  Avecia Limited

  PO Box 42, Hexagon House

  Blackley, Manchester, M9
  8ZS, UK

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
   

  	
   

  	
  x

  	
  10A. MODIFICATION OF
  CONTRACT/ORDER NO.

  
	
   

  	
   

  	
   

  	
  NO1-AI-30052

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  10B. DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
   

  	
  09/30/2003

  

 

11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS

 

oThe above numbered solicitation is amended as set forth
in Item 14.  The hour and date specified
for receipt of Offers         ois extended,  ois not extended

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:

 

(a) By completing
Items 8 and 15, and returning one (1) copy of the amendment; (b) By
acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the solicitation
and amendment numbers.  FAILURE OF YOUR
ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF
OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF
YOUR OFFER.  If by virtue of this
amendment, you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes references
to the solicitation and this amendment, and is received prior to the opening
hour and date specified.

 

12. ACCOUNTING AND APPROPRIATION
DATA (If required)

EIN 1-900216013 - A1 SOCC 25.55

 

13. THIS ITEM APPLIES ONLY TO
MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

	
  o

  	
  A.

  	
  THIS
  CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

  

 

	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation
  date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

  

 

	
  x

  	
  C.

  	
  THIS SUPPLEMENTAL
  AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: 

  P.L. 1.602-1

  

 

	
   

  	
  D.

  	
  OTHER
  (Specify type of modification and authority)

  

 

	
  E.             IMPORTANT:  Contractor o is not, x is required to sign this document and
  return 2 copies to the issuing office.

  

 

	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
   

  
	
  PURPOSE: 
  To increase the Total Estimated Cost and Fixed Fee; clarify Part B
  Statement and Work and the corresponding milestones; and to extend the
  contract completion date.

  

 

	
   

  	
   

  	
  TOTAL FUNDS ALLOTTED

  	
   

  	
  TOTAL ESTIMATED COST

  
	
  AMOUNT

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  
	
  Prior to this
  Mod:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  This Mod #01:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  Revised TOTAL

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  

 

	
  FUNDED THROUGH DATE:

  	
   [***]

  	
  COMPLETION DATE:

  	
   [***]

  

 

	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  
	
   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

                             [***]

                             [***]

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

                                                    
  [***]

                                                    
  [***]

  

 

	
  15B.  CONTRACTOR/OFFEROR
                              [***]

  	
  15C.  DATE SIGNED

  20 August 2007

  	
  16B.  UNITED STATES OF AMERICA

   

  	
  16C.  DATE SIGNED

  
	
   

  	
   

  	
   

  	
  BY

  	
   

  	
   

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
   

  	
   

  	
  (Signature of Contracting
  Officer)

  	
   

  
							

 

	
  NSN 7540-01-152-8070

  PREVIOUS EDITION
  UNUSABLE

  	
  30-105

  Computer Generated

  	
  STANDARD FORM 30
  (REV. 10-83)

  Prescribed by GSA

  FAR (48 CFR 53 243)

  

 

 

	
  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  N/A

  	
  PAGE OF PAGES

  
	
  1

  	
  8

  

 

	
  2.  AMENDMENT/MODIFICATION NO

  	
  3.  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  	
  5.  PROJECT NO. (If applicable)

  
	
  10

  	
      [see block 16C, below]

  	
  DMIO 2 017

  	
  N/A

  

 

	
  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  National Institute of Allergy and Infectious Diseases

  DEA, Contract Management Branch

  Room 3214, MSC 7812

  6700-B Rockledge Drive

  Bethesda, MD 20892-7612

  	
  MID2-RCB

  
	
   

  

 

	
  8. NAME AND ADDRESS OF
  CONTRACTOR (No., Street, County, State and ZIP Code)

  	
  o

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  
	
  Avecia Limited

  PO Box 42, Hexagon House

  Blackley, Manchester, M9 8ZS, UK

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
   

  	
   

  	
  x

  	
  10A. MODIFICATION OF
  CONTRACT/ORDER NO.

  
	
   

  	
   

  	
   

  	
  NO1-AI-30052

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  10B. DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
  09/30/2003

  

 

11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set
forth in Item 14.  The hour and date
specified for receipt of Offers          ois extended, ois not extended

 

Offers must acknowledge
receipt of this amendment prior to the hour and date specified in the
solicitation or as amended, by one of the following methods:

 

(a) By completing
Items 8 and 15, and returning one (1) copy of the amendment; (b) By
acknowledging receipt of this amendment on each copy of the offer submitted; or
(c) By separate letter or telegram which includes a reference to the
solicitation and amendment numbers. 
FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT
IN REJECTION OF YOUR OFFER.  If by virtue
of this amendment, you desire to change an offer already submitted, such change
may be made by telegram or letter, provided each telegram or letter makes
references to the solicitation and this amendment, and is received prior to the
opening hour and date specified.

 

12. ACCOUNTING AND
APPROPRIATION DATA (If required)

EIN 1-900216013-A1 SOCC 25.55

 

13. THIS ITEM APPLIES ONLY TO
MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

	
  o

  	
  A.

  	
  THIS
  CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

  

 

	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation
  date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

  

 

	
  x

  	
  C.

  	
  THIS SUPPLEMENTAL
  AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  P.L. 1.602-1

  

 

	
   

  	
  D.

  	
  OTHER
  (Specify type of modification and authority)

  
	
   

  	
  E.

  	
  IMPORTANT:  Contractor o is not, x is required to sign this document and
  return 2 copies to the issuing office.

  

 

	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE: 
  Fixed fee; clarify font B statement of Work and the corresponding
  miles tones; and to extend the contract completion date.

  

 

	
   

  	
   

  	
  TOTAL FUNDS ALLOTTED

  	
   

  	
  TOTAL ESTIMATED COST

  
	
  AMOUNT

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  
	
  Prior to this
  MOD:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  This Mod #:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
  Revised TOTAL

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  

 

	
  FUNDED THROUGH DATE:

  	
   

  	
  August 31, 2009
  (Unchanged)

  	
   

  	
  COMPLETION DATE:

  	
   

  	
  August 31, 2013
  (Unchanged)

  

 

	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  

 

	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  [***]

  [***]

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

  [***]

  [***]

  

 

	
  15B.  CONTRACTOR/OFFEROR

                                   [***]

  	
  15C.  DATE SIGNED

   

  	
  16B.  UNITED STATES OF AMERICA
                         [***]

  	
  16C.  DATE SIGNED

                    [***]

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  20 August 2007

  	
  BY

  	
   

  	
   

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
  (Signature of Contracting
  Officer)

  	
   

  
							

 

	
  NSN 7540-01-152-8070

  PREVIOUS EDITION
  UNUSABLE

  	
  30-105

  Computer Generated

  	
  STANDARD FORM 30
  (REV. 10-83)

  Prescribed by GSA

  FAR (48 CFR) 53.243

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 2 of 8

  

 

ARTICLE B.2.  ESTIMATED COST AND FIXED FEE,
- paragraphs a., b., and c. are hereby modified to read as follows:

 

a.                                       The
estimated cost of this contract is increased by [***] from  [***] to 
[***].

 

b.                                      The
fixed fee for this contract is increased by [***] from  [***] to 
[***].

 

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

 

ARTICLE
B.4.  ADVANCE UNDERSTANDINGS, paragraph
h., is hereby modified to revise the submilestone estimated cost, fixed fee,
total cost plus fixed fee, and clarification of the work to be completed per
milestone; detail as follows (all other aspects and descriptions of the
milestone chart remain unchanged):

 

	
   

  	
   

  	
  MILESTONES
  FOR AVECIA

  	
   

  	
  ESTIMATED
  

  COST

  	
   

  	
  FIXED
  FEE

  	
   

  	
  TOTAL
  

  CPFF

  
	
  4

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***] 

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***] 

  	
   

  	
   

  	
   

  	
  b) [***] 

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  5

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in two installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***] 

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 3 of 8

  

 

	
  6

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]  

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in three installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***] 

  	
   

  	
   

  	
   

  	
  b) [***] 

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  7

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  8

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in six installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 4 of 8

  

 

	
  10

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in three installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  g) [***]

  	
   

  	
   

  	
   

  	
  g) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  h) [***]

  	
   

  	
   

  	
   

  	
  h) [***]

  	
   

  	
   

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 5 of 8

  

 

	
  11

  	
   

  	
  [***] 

  	
   

  	
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  [***]    

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in five installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***] 

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***] 

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d) [***] 

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 6 of 8

  

 

	
  12

  	
   

  	
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  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in two installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  13

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]    

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in six installments for this milestone based on the completion of the
  following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d)
  [***]  

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  14

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]   

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in three yearly installments for this milestone based on the completion
  of the following items:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a)
  [***]  

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 7 of 8

  

 

	
  15

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in three equal installments (one each year) on provision of 

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  16

  	
   

  	
  [***] 

  	
   

  	
  [***]

  	
   

  	
  [***]    

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Fee shall be
  paid in three installments (one each year) upon completion

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  	
   

  	
  a) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  	
   

  	
  b) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  	
   

  	
  c) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  	
   

  	
  d) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  	
   

  	
  e) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  	
   

  	
  f) [***]

  	
   

  	
   

  

 

 

	
  Contract
  No: N01-AI-30052

  Modification No: 10

  	
   

  	
  SPECIAL PROVISIONS

  	
   

  	
  Page 8 of 8

  

 

	
   

  	
   

  	
  g) [***]

  	
   

  	
   

  	
   

  	
  g) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  h) [***]

  	
   

  	
   

  	
   

  	
  h) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  i) [***]

  	
   

  	
   

  	
   

  	
  i) [***]

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  j) [***]

  	
   

  	
   

  	
   

  	
  j) [***]

  	
   

  	
   

  

 

 

	
  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

  	
  1.  CONTRACT ID CODE

  N/A

  	
  PAGE OF PAGES

  
	
  1

  	
  3

  

 

	
  2.  AMENDMENT/MODIFICATION NO

  	
  3.  EFFECTIVE DATE

  	
  4.  REQUISITION/PURCHASE REQ. NO.

  	
  5.  PROJECT NO. (If applicable)

  
	
  11

  	
       [see
  block 16C, below]

  	
  182712

  	
  N/A

  

 

	
  ISSUED BY

  	
  CODE

  	
   

  	
  7.  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
       N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  National Institutes of
  Health

  National Institute of
  Allergy and Infectious Diseases

  DEA, Contract Management
  Branch

  Room 3214, MSC 7612

  6700-B Rockledge Drive

  Bethesda, MD 20892-7612

  	
  MID2-RCB

  
	
   

  VIN:  1109979

  

 

	
  8. NAME AND ADDRESS OF
  CONTRACTOR (No., street, country, State and ZIP Code)

  	
  o

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
   

  
	
  Avecia Limited

  PO Box 42, Hexagon House

  Blackley, Manchester, M9
  8ZS, UK

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
   

  	
   

  	
  x

  	
  10A. MODIFICATION OF
  CONTRACT/ORDER NO.

  
	
   

  	
   

  	
   

  	
  N01-AI-30052

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  10B. DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
  09/30/2003

  

 

11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS

 

	
  o The above numbered solicitation is
  amended as set forth in Item 14. The hour and date specified for receipt of
  Offers       ois extended, ois not extended

  

 

	
  Offers must
  acknowledge receipt of this amendment prior to the hour and date specified in
  the solicitation or as amended, by one of the following methods:

   

  (a) By
  completing Items 8 and 15, and returning one (1) copy of the amendment;
  (b) By acknowledging receipt of this amendment on each copy of the offer
  submitted; or (c) By separate letter or telegram which includes a reference
  to the solicitation and amendment numbers. 
  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
  FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED
  MAY RESULT IN REJECTION OF YOUR OFFER. 
  If by virtue of this amendment, you desire to change an offer already
  submitted, such change may be made by telegram or letter, provided each
  telegram or letter makes references to the solicitation and this amendment,
  and is received prior to the opening hour and date specified.

  

 

	
  12. ACCOUNTING AND
  APPROPRIATION DATA (If required)

  EIN 1-900216013-A1                              SOCC 25.55          CAN: 
  8475593      [***]

  

 

	
  13. THIS ITEM APPLIES ONLY TO
  MODIFICATIONS OF CONTRACTS/ORDERS,

  IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

  

 

	
  o

  	
  A.

  	
  THIS
  CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE
  MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

  

 

	
   

  	
  B.

  	
  THE
  ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
  CHANGES (such as changes in paying office, appropriation
  date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
  43.103(b).

  

 

	
   

  	
  C.

  	
  THIS SUPPLEMENTAL
  AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  

 

	
  x

  	
  D.

  	
  OTHER (Specify type of modification and authority)

  FAR 1.602-1 and FAR
  52.232-11, Limitation of Funds

  

 

	
   

  	
  E.

  	
  IMPORTANT:  Contractor x is not, o is required to sign this document and
  return 2 copies to the issuing office.

  

 

	
  14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE: 
  The purpose of this modification is to add an increment of funds.

  

 

	
   

  	
   

  	
  TOTAL FUNDS ALLOTTED

  	
   

  	
  TOTAL ESTIMATED COST

  	
   

  
	
  AMOUNT

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  
	
  Total Prior to
  this MOD:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  MOD #01:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  
	
  TOTAL

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  

 

	
  FUNDED THROUGH DATE:

  	
  [***]

  	
  COMPLETION DATE:

  	
  [***]

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  

 

	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TILE OF CONTRACTING OFFICER (Type or print)

  [***]

  [***]

  

 

	
  15B. CONTRACTOR/OFFEROR

  	
   

  	
  15C. DATE SIGNED

  	
  16B. UNITED STATES OF
  AMERICA

  	
   

  	
  16C. DATE SIGNED 

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
  [***]

  
	
   

  	
   

  	
   

  	
  BY

  	
  [***]

  	
   

  	
   

  
	
  (Signature
  of person authorized to sign)

  	
   

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  	
   

  
							

 

	
  NSN 7540-01-152-8070

  PREVIOUS EDITION
  UNUSABLE

  	
  30-105

  Computer Generated

  	
  STANDARD FORM 30
  (REV. 10-83)

  Prescribed by GSA

  FAR (48 CFR) 53 243

  

 

 

	
  Contract No:  N01-A1-30052

  Modification No:  11

  	
  SPECIAL
  PROVISIONS

  	
  Page 2 of 3

  

 

ARTICLE B.2.  ESTIMATED  COST AND FIXED FEE, - paragraphs d. and e., are hereby
modified to read as follows:

 

	
  d.

  	
  Total funds
  currently available for payment and allotted to this contract are hereby
  increased by [***] from [***] to [***]; of which [***] represents an increase
  to the estimated cost from [***] to [***]; and of which [***] represents an
  increase to the fixed fee from [***] to [***]. For further provisions on
  funding, see the LIMITATION OF FUNDS Clause referenced in Part II,
  ARTICLE I.1., General Clauses for a Cost-Reimbursement Research and
  Development Contract.

  
	
   

  	
   

  
	
  e.

  	
  It is
  estimated that the amount currently allotted will cover performance through
  January 31, 2011.

  

 

ARTICLE
H.6.  CONTINUED BAN ON FUNDING OF
HUMAN EMBRYO RESEARCH, paragraph b. is hereby
modified to add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal Year

  	
   

  	
  Period Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  110-005, Section 509 *

  	
   

  	
  2007

  	
   

  	
  10/01/06 -
  09/30/07

  

 

	
   

  	
  *Public Law
  110-005, Revised Continuing Appropriations Resolution, 2007, extends the
  legislative provisions provided in the FY 2006 Appropriations Act (Public Law
  109-149) through the end of FY 2007.

  

 

ARTICLE
H.7.  NEEDLE EXCHANGE,
paragraph b. is hereby modified to add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  110-005, Section 505 *

  	
   

  	
  2007

  	
   

  	
  10/01/06 -
  09/30/07

  

 

	
   

  	
  *Public Law
  110-005, Revised Continuing Appropriations Resolution, 2007, extends the
  legislative provisions provided in the FY 2006 Appropriations Act (Public Law
  109-149) through the end of FY 2007.

  

 

ARTICLE
H.12.  SALARY RATE LIMITATION LEGISLATION PROVISIONS,
paragraphs b. and c. are hereby modified to add the following:

 

	
  b.

  	
  Public Law and No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Dollar
  Amount of Salary Limitation*

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  110-005, Section 204 *

  	
   

  	
  2007

  	
   

  	
  Executive
  Level I

  

 

	
   

  	
  *Public Law 110-005, Revised Continuing Appropriations Resolution, 2007,
  extends the legislative provisions provided in the FY 2006 Appropriations Act
  (Public Law 109-149) through the end of FY 2007.  Therefore, the provision that restricts the
  amount of direct salary to Executive Level I of the Federal Executive Pay
  Scale continues through FY 2007.  The
  Executive Level I annual salary rate was $183,500 for the period January 1
  through December 31, 2006. 
  Effective January 1, 2007, the Executive Level I salary rate
  increased to $186,600.

  
	
   

  	
   

  
	
  c.

  	
  Payment of
  direct salaries is limited to the Executive I* rate which was in effect on
  the date(s) the expense was incurred.

  

 

HHS-556

 

 

	
  Contract No:  N01-A1-30052

  Modification No:  11

  	
  SPECIAL
  PROVISIONS

  	
  Page 3 of 3

  

 

FOR FY -07 EXECUTIVE LEVEL
SALARIES EFFECTIVE JANUARY 1, 2007:

http://www.opm.gov/oca/07tables/html/ex.asp

(Note:  This site shows the FY-07 rates.  For previous years, click on “salaries and
wages” and then scroll down to the bottom of the pages and click on the
year to locate the desired Executive Level salary rates.)

 

	
  NOTE:

  	
  All prior Public Laws and related Executive Levels incorporated in
  the Basic Award and all previous Modifications shall remain in effect for the
  applicable fiscal year and related funds.

  

 

ARTICLE
H.14.  PRESS RELEASES,  paragraph b., is hereby modified to add the following:

 

	
  b.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  P.L.
  110-005, Section 506 *

  	
   

  	
  2007

  	
   

  	
  10/01/06 -
  09/30/07

  

 

	
   

  	
  *Public Law
  110-005, Revised Continuing Appropriations Resolution, 2007, extends the
  legislative provisions provided in the FY 2006 Appropriations Act (Public Law
  109-149) through the end of FY 2007.

  

 

ARTICLE
H.16.  ANTI-LOBBYING,
paragraph c., is hereby modified to add the following:

 

	
  c.

  	
  Public Law and Section No.

  	
   

  	
  Fiscal
  Year

  	
   

  	
  Period
  Covered

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  for a.,
  above:  P.L. 110-005, Section 503(a)*

  	
   

  	
  2007

  	
   

  	
  10/01/06 -
  9/30/07

  
	
   

  	
  for b.,
  above:  P.L. 110-005, Section 503(b)*

  	
   

  	
  2007

  	
   

  	
  10/01/06 -
  9/30/07

  

 

	
   

  	
  *Public
  Law 110-005, Revised Continuing Appropriations Resolution, 2007, extends the
  legislative provisions provided in the FY 2006 Appropriations Act (Public Law
  109-149) through the end of FY 2007.

  

 

HHS-556

 

 

[Letterhead of Department of Health and Human Services]

 

	
   

  	
  Division of Microbiology and Infectious Diseases

  
	
   

  	
  National Institute of Allergy and Infectious Diseases

  
	
   

  	
  Room 6111, 6610 Rockledge Drive

  
	
   

  	
  Bethesda, MD 20892-6603

  
	
   

  	
  Ph:  301-496-1884

  
	
  [***]

  	
   

  
	
  Avecia Biotechnology

  	
   

  
	
  PO Box 2, Belasis Avenue

  	
   

  
	
  Billingham

  	
   

  
	
  TS23 1 YN United Kingdom

  	
   

  
	
   

  	
   

  
	
  June 12, 2006

  	
   

  
	
   

  	
   

  
	
  Re: [***]

  
	
   

  	
   

  
	
  Dear Dr. Duchars,

  
	
   

  
	
  [***]

  
	
   

  
	
  [***]

  
	
  1. Not
  to further modify the CDC approved modified code

  2. To
  use the routines exclusively for government purposes within the scope of the
  DMID contract.

  3. To
  contact the CDC for a commercial use license in the event the routines are
  required for any private or commercial purposes.

  
	
   

  
	
  If Avecia Biotechnology agrees with the terms of this LoA please have
  an authorized signatory sign below.

  
	
   

  
	
  [***]

  
	
   

  
	
   

  
	
  [***]

  	
   

  
	
  [***]

  	
   

  
	
  Division of Microbiology and Infectious Diseases

  
	
   

  
	
  Accepted and Agreed on behalf of Avecia
  Biotechnology:

  
			

 

	
  [***]

  	
   

  	
  Date:

  	
  [***]

  
	
    [***]

  	
   

  	
   

  	
   

  
	
    [***]

  	
   

  	
   

  	
   

  

 

 

[Letterhead of Department of Health and Human Services]

 

	
  [***]

  	
   

  
	
  Avecia Biotechnology

  	
  6610 Rockledge Dr

  
	
  Belasis Avenue

  	
  Room 5119

  
	
  Billingham, Cleveland

  	
  Bethesda, MD 20892-6604

  
	
  TS23 1YN, United Kingdom

  	
  Ph 301-451-4806

  
	
   

  	
  Fax 301-496-8030

  
	
   

  	
  swinram@niaid.nih.gov

  
	
   

  	
   

  
	
  RE: 
  Letter of Agreement - NIAID’s Clinical Trials using Avecia’s rPA
  Vaccine Candidate

  
	
   

  
	
  Dear Matthew,

  
	
   

  
	
  [***]

  
	
   

  
	
  [***]

  
	
   

  
	
  NIAID agrees that Avecia may have the following involvement in the
  DMID sponsored clinical trial:

  
	
   

  
	
  [***]

  

 

Data generated by studies using Avecia’s vaccine candidate will be
owned by NIAID but will be made available to Avecia, at no cost.  Once a clinical trial has been completed, the
data obtained may be published with the prior written permission of NIAID.  NIAID will provide Avecia an opportunity to
review and comment on proposed publications.

 

Please indicate your acceptance of these terms by having an authorized
representative from Avecia Biotechnology sign below.  At your earliest convenience, kindly return a
copy of this letter to my attention, and then please mail the signed original
using the contact information above.

 

	
   

  
	
  Sincerely,

  	
  Authorized Representative for Avecia Biotechnology:

  
	
   

  	
   

  
	
   

  	
  [***]  30th June 2004

  
	
  [***]

  	
  Signature & Date

  
	
  [***]

  	
   

  
	
  [***]

  	
  Name:

  	
  [***]

  
	
  [***]

  	
   

  	
   

  
	
  July 2, 2007

  	
  Title:

  	
  [***]

  

 

 

	
  AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

  	
  1  CONTRACT ID CODE

  	
  PAGE OF PAGES

  
	
  N/A

  	
  1

  	
  2

   

  
	
  2  AMENDMENT/MODIFICATION NO

  	
  3  EFFECTIVE DATE

  	
  4  REQUISITION/PURCHASE REQ. NO.

  	
  5  PROJECT NO (If
  applicable)

  
	
  13

  	
  [see block 16C, below]

  	
   

  	
   

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  6  ISSUED BY

  	
  CODE

  	
   

  	
  7  ADMINISTERED BY (If other
  than Item 6)

  	
  CODE

  	
  N/A

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
  National Institutes of
  Health

  National Institute of Allergy and Infectious Diseases

  DEA, Contract Management Branch

  Room 3214, MSC 7612

  5700-B Rockledge Drive

  Bethesda, MD 20892-7612

   

  	
  MID - RCB-B

  
	
   

  
	
  8.  NAME AND ADDRESS OF CONTRACTOR (No Street County State and ZIP Code)

  	
  x

  	
  9A.  AMENDMENT OF SOLICITATION NO

  
	
   

  
	
   

  	
  PharmAthene UK, Limited
  VIN:  1148448

  Johnson Matthey Building

  PO Box 88, Haverton Hill Road

  Billingham TS23 1XN

  	
   

  	
  9B.  DATED (SEE ITEM 11)

  
	
  x

  	
  10A.
  MODIFICATION OF CONTRACT/ORDER NO

  
	
  NO1-AI-30052

   

  
	
   

  	
  10B.  DATED (SEE ITEM 13)

  
	
  CODE

  	
  FACILITY CODE

  	
  09/30/2003

  
	
   

  
	
  11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF
  SOLICITATIONS

  
	
   

  
	
  o The above numbered solicitation is
  amended as set forth in Item 14.  The
  hour and date specified for receipt of Offers      o is extended,          o is not extended. 

   

  Offers must acknowledge receipt of this amendment
  prior to the hour and date specified in the solicitation or as amended, by
  one of the following methods:

   

  (a) By completing
  Items 8 and 15, and returning one (1) copy of the amendment; (b) By
  acknowledging receipt of this amendment on each copy of the offer submitted
  or (c) By separate letter or telegram which includes a reference to the
  solicitation and amendment numbers. 
  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED
  FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT
  IN REJECTION OF YOUR OFFER.  If by
  virtue of this amendment you desire to change an offer already submitted,
  such change may be made by telegram or letter, provided each telegram or
  letter makes reference to the solicitation and this amendment, and is
  received prior to the opening hour and date specified

   

  
	
  12.  ACCOUNTING AND APPROPRIATION DATA (If required)

     SOCC 25.55

   

  
	
  13.  THIS ITEM APPLIES ONLY TO MODIFICATIONS OF
  CONTRACTS/ORDERS,

  IT MODIFIES THE CONTRACT/ORDER NO.  AS
  DESCRIBED IN ITEM 14.

   

  
	
  (C)

  	
  A.             THIS CHANGE ORDER IS ISSUED PURSUANT
  TO  (Specify
  authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE
  CONTRACT ORDER NO IN ITEM 10A.

   

  
	
   

  
	
   

  	
  B.              THE ABOVE NUMBERED CONTRACT/ORDER IS
  MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as
  changes in paying office, appropriation date, etc.)  SET FORTH IN ITEM 14, PURSUANT TO THE
  AUTHORITY OF FAR 43.103(b).

   

  
	
  x

  	
  C.                THIS
  SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

  FAR 42,12 and FAR 1.502-1

  
																

 

	
   

  	
  D.             OTHER (Specify type of modification and
  authority)

   

  
	
  E. 
  IMPORTANT:  Contractor                o is not,  x 
  is required to sign this document and return 2 copies to the issuing
  office.

   

  
	
  14  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract
  subject matter where feasible)

  
	
  PURPOSE: 
  To recognize the Contractor’s successor in Interest from Avecia
  Biologica Limited to Pharmothene UK, Limited, to revise ARTICLE B.4.  ADVANCED UNDERSTANDINGS and ARTICLE
  G.1.  PROJECT OFFICER.

  

	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Total Funds Currently Allotted

  	
   

  	
  Total Estimated Cost

  	
   

  
	
   

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  	
  Cost

  	
   

  	
  Fee

  	
   

  	
  Total

  	
   

  
	
  Prior to this Mod:

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  117,736,200

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  118,036,200

  	
   

  
	
  This Mod #

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  -0-

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  -0-

  	
   

  
	
  Revised Total

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  117,736,200

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  $

  	
  118,036,200

  	
   

  

	
   

  	
   

  
	
  FUNDED THROUGH
  DATE:  January 31, 2001
  (Unchanged)

  	
  COMPLETION
  DATE:  August 31, 2013 (Unchanged)

  
	
   

  
	
  Except as provided
  herein, all terms and conditions of the document referenced in Item 9A or
  10A, as heretofore changed, remains unchanged and in full force and effect.

  
	
   

  
	
  15A.  NAME AND TITLE OF SIGNER (Type or print)

  	
  16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

  
	
  Chris Camut, VP, CFO/UK
  Board of Directors

  	
  Karen M. Gamble

  
	
  Contracting Officer,
  DEA, NIAID, HIH

  
	
   

  	
   

  
	
  15B.  CONTRACTOR/OFFEROR

  	
  15C.  DATE SIGNED

  	
  16B.  UNITED STATES OF AMERICA

  	
  16C.  DATE SIGNED

  
	
   

  	
  12/4/08

  	
   

  	
  12/4/08

  
	
  /s/
  Chris Camut

  	
   

  	
  BY

  	
  /s/
  Karen Gamble

  	
   

  
	
  (Signature of person authorized to sign)

  	
   

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NSN 7540-01-152-8070

  PREVIOUS EDITION UNUSABLE

  	
  30-105

  Computer Generated

  	
  STANDARD FORM 30
  (REV. 10-83)

  Prescribed by GRA

  FAR (48 CPR) 53.243

  
								

 

 

	
  Contract No:  N01-A1-30052

  Modification No:  13

  	
  SPECIAL
  PROVISIONS

   

  	
  Page 2 of 2

  

 

Pursuant to FAR 42.12, Block 8 of the
Standard Form 30 shall read as follows:

 

PharmAthene
UK, Limited VIN: 1148448

Johnson Matthey Building

PO Box 88, Haverton Hill Road

Billingham TS23 1XN

 

The following is attached and made part of
this modification:

 

Novation
Agreement

Exhibit A, List of all Affected Contracts

 

ARTICLE B.4.  ADVANCED
UNDERSTANDINGS, paragraph g. Ceilings, is modified to add the following:

 

(8)              As a result of this
novation, it is agreed that the Total Estimated Cost of this Contract shall not
exceed the current value of $118,036,200, due to any variances in the indirect
costs.

 

ARTICLE G.1.  PROJECT OFFICER, is
modified to add the following:

 

The Alternate Project Officer named below will represent the Government
for the purpose of this contract:

 

Nancy Wilkie

Office of Biodefense Research Affairs (OBRA)

Division of Microbiology and Infectious Diseases

DHHS/NIH/NIAID

Room 5004, MSC 6604

6610 Rockledge Drive

Bethesda, MD  20892-6604

wilkien@niaid.nih.gov

 

	
  HHS-556

  

 

 

NOVATION
AGREEMENT

 

AVECIA BIOLOGICS LIMITED
(Transferor), a corporation duly organized and existing under the laws of
England and Wales with its principal office in Manchester United Kingdom; PHARMATHENE UK LIMITED (Transferee), a corporation duly
organized and existing under the laws of England and Wales with its principal office
in Billingham, UK; and the UNITED STATES OF AMERICA
(Government) enter into this Agreement as of 2nd April, 2008.

 

(a)   The parties agree to the
following facts:

 

(1)   The Government, represented by various
Contracting Officers of the National Institute for Allergies and Infectious
Diseases, has entered into certain contracts with the Transferor as shown in
the attached list marked ‘Exhibit A’ and incorporated in this Agreement by
reference.  The term “the contracts,” as
used in this Agreement, means the above contracts and purchase orders and all
other contracts and purchase orders, including all modifications, made between
the Government and the Transferor before the effective date of this Agreement
(whether or not performance and payment have been completed and releases
executed if the Government or the Transferor has any remaining rights, duties,
or obligations under these contracts and purchase orders).  Included in the term “the contracts” are also
all modifications made under the terms and conditions of these contracts and
purchase orders between the Government and the Transferee, on or after the
effective date of this Agreement.

 

(2)   As of 2nd April, 2008, the Transferor has transferred to
the Transferee all the assets of the Transferor by virtue of a Sale and
Purchase Agreement between the Transferor and the Transferee.

 

(3)   The Transferee has acquired
all the assets of the Transferor by virtue of the above transfer.

 

(4)   The Transferee has assumed
all obligations and liabilities of the Transferor under the contracts by virtue
of the above transfer.

 

(5)   The Transferee is In a
position to fully perform all obligations that may exist under the contracts.

 

(6)   It is consistent with the
Government’s interest to recognize the Transferee as the successor party to the
contracts.

 

(7)   Evidence of the above transfer has been filed
with the Government.

 

(b)   In consideration of these
facts, the parties agree that by this Agreement—

 

(1)   The Transferor confirms the transfer to the
Transferee, and waives any claims and rights against the Government that it now
has or may have in the future in connection with the contracts.

 

(2)   The Transferee agrees to be bound by and to
perform each contract in accordance with the conditions contained in the
contracts.  The Transferee also

 

 

assumes all obligations and liabilities of, and all claims against, the
Transferor under the contracts as if the Transferee were the original party to
the contracts.

 

(3)   The Transferee ratifies all previous actions
taken by the Transferor with respect to the contracts, with the same force and
effect as if the action had been taken by the Transferee.

 

(4)   The Government recognizes
the Transferee as the Transferor’s successor in interest in and to the
contracts.  The Transferee by this Agreement
becomes entitled to all rights, titles, and interests of the Transferor in and
to the contracts as if the Transferee were the original party to the
contracts.  Following the effective date
of this Agreement, the term “Contractor,” as used in the contracts, shall refer
to the Transferee.

 

(5)   Except as expressly provided
in this Agreement, nothing in it shall be construed as a waiver of any rights
of the Government against the Transferor.

 

(6)   All payments and
reimbursements previously made by the Government to the Transferor, and all
other previous actions taken by the Government under the contracts, shall be
considered to have discharged those parts of the Government’s obligations under
the contracts.  All payments and
reimbursements made by the Government after the date of this Agreement in the
name of or to the Transferor shall have the same force and effect as if made to
the Transferee, and shall constitute a complete discharge of the Government’s
obligations under the contracts, to the extent of the amounts paid or
reimbursed.

 

(7)   The Transferor and the
Transferee agree that the Government is not obligated to pay or reimburse
either of them for, or otherwise give effect to, any costs, taxes, or other
expenses, or any related increases, directly or indirectly arising out of or
resulting from the transfer or this Agreement, other than those that the
Government in the absence of this transfer or Agreement would have been
obligated to pay or reimburse under the terms of the contracts.

 

(8)   The Transferor guarantees payment of all
liabilities and the performance of all obligations that the Transferee—

 

(i)    Assumes under this
Agreement; or

 

(ii)   May undertake in the
future should these contracts be modified under their terms and
conditions.  The Transferor waives notice
of, and consents to, any such future modifications.

 

(9)   The contracts shall remain in full force and
effect, except as modified by this Agreement. 
Each party has executed this Agreement as of the day and year first
above written.

 

UNITED STATES OF AMERICA,

 

	
  Signed

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  
	
  Name and Title

  	
  [***]

  	
   

  

 

 

AVECIA BIOLOGICS LIMITED,

 

	
  Signed

  	
  /s/ Duncan McLellan

  	
   

  
	
   

  	
   

  
	
  Name and Title

  	
  Duncan McLellan - Director and Chief
  Financial Officer

  

 

PHARMATHENE UK LIMITED,

 

	
  Signed

  	
  /s/ David P. Wright

  	
   

  
	
   

  	
   

  
	
  Name and Title

  	
  David P. Wright - CEO

  

 

CERTIFICATE

 

I, Richard Clements,
certify that I am the Company Secretary of AVECIA BIOLOGICS LIMITED, that
Duncan McLellan, who signed this Agreement for this corporation, was then a
Director and the Chief Financial Officer of this corporation; and that this
Agreement was duly signed for and on behalf of this corporation by authority of
its governing body and within the scope of its corporate powers.  Witness my hand this day of 2nd June 2008.

 

	
  Signed

  	
  /s/ Richard Clements

  	
   

  

 

CERTIFICATE

 

I, Christopher C. Camut,
certify that I am the Company Secretary of PHARMATHENE UK LIMITED, that
David P. Wright, who signed this Agreement for this corporation, was then
a Director of this corporation; and that this Agreement was duly signed for and
on behalf of this corporation by authority of its governing body and within the
scope of its corporate powers.  Witness
my hand this day of 23 June 2008.

 

	
  Signed

  	
  /s/ Christopher C. Camut

  	
   

  

 

 

Exhibit A

 

The Contracts

 

Contract number N01-AI-25492

 

Contract
between Avecia Biologics Limited and the National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development and Testing of Vaccines Against Anthrax.”

 

Contract number N01-AI-30052

 

Contract
between Avecia Biologics Limited and the National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Production and Testing of Anthrax Recombinant Protective Antigen.”

 

Contract number HHSN266200400034C, N01-AI-40034

 

Contract
between Avecia Biologics Limited and the National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development, Testing and Evaluation of Candidate Vaccines Against
Plague.”

 

 

List of Affected Contracts

 

Contract number N01-AI-25492

 

Contract
between Avecia Biologics Limited and the National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development and Testing of Vaccines Against Anthrax.”

 

This contract
is substantially complete.  As at 15th January 2008, the total contract amount
was $10,155,120 and there was an [***] which is under discussion between Avecia
Biologics Limited and NIAID.

 

	
  Contracting
  Office:

  	
   

  	
  National
  Institutes of Health

  
	
   

  	
   

  	
  Office of
  Acquisitions, NIAID

  
	
   

  	
   

  	
  Room 3214

  
	
   

  	
   

  	
  6700-B
  Rockledge Dr., MSC 7612

  
	
   

  	
   

  	
  Bethesda,
  Maryland 20892-7612

  

 

Contract number N01-AI-30052

 

Contract
between Avecia Biologics Limited and the National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Production and Testing of Anthrax Recombinant Protective Antigen.”

 

As at 15th April 2008, the total contract value was
$118,036,200 and the total estimated costs remaining to complete were [***].

 

	
  Contracting
  Office:

  	
   

  	
  National
  Institutes of Health

  
	
   

  	
   

  	
  Office of
  Acquisitions, NIAID

  
	
   

  	
   

  	
  Room 3214

  
	
   

  	
   

  	
  6700-B
  Rockledge Dr., MSC 7612

  
	
   

  	
   

  	
  Bethesda,
  Maryland 20892-7612

  

 

Contract number HHSN266200400034C, N01-AI-40034

 

Contract
between Avecia Biologics Limited and the National Institute of Allergy and
Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development, Testing and Evaluation of Candidate Vaccines Against
Plague.”

 

As at 15th April 2008, the total contract value was
$50,701,714 and the total estimated costs remaining to complete were [***].

 

	
  Contracting
  Office:

  	
   

  	
  National
  Institutes of Health

  
	
   

  	
   

  	
  Office of
  Acquisitions, NIAID

  
	
   

  	
   

  	
  Room 3214

  
	
   

  	
   

  	
  6700-B
  Rockledge Dr., MSC 7612

  
	
   

  	
   

  	
  Bethesda,
  Maryland 20892-7612

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