Document:

exv4w51

 

Exhibit 4.51

 

Confidential treatment has been requested for certain portions of this exhibit. The copy filed
herewith omits the information subject to the confidential treatment request. Omissions are
designated as “ ***** ”. A complete version of this exhibit has been filed separately with the
Commission pursuant to an application for confidential treatment under Rule 24b-2 promulgated under
the Securities Exchange Act of 1934, as amended.

 

ADB No. N01-AI-40071

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 

	 	1. THIS CONTRACT IS A RATED ORDER
	 	RATING
	 	PAGE
	 	OF
	 	PAGES

	AWARD/CONTRACT

	 	     UNDER DPAS (15 CFR 350)                      4
	 	     N/A
	 	 	1	 	 	 	 	 	27	 
	 

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

	 	3. EFFECTIVE DATE
	 	4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
	     HHSN266200400071C

	 	     September 30, 2004
	 	          VRCB148
	 

	 	 	 	 	 	 	 	 	 	 	 
	5. ISSUED BY

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

	 	 	 	 
	 	 	 	 	 	 
	     National Institutes of Health, DHHS
	 	 	 	 	 	 	 	 	 	 
	     Contract Management Program, NIAID	 	 	 	 	 	 	 	 
	     Room 3214
	 	 	 	 	 	 	 	 	 	 
	     6700-B Rockledge Dr., MSC 7612

	 	 	 	 	 	     RFP NIH-NIAID-DMID-04-49	 	 	 	 
	     Bethesda, Maryland 20892-7612
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

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

	 	 	 	     o FOB ORIGIN
	 	   x OTHER (See below)
	 

	 	 	 	 	 	FOB Destination
	 	 	 	 	 
	     Acambis, Inc.	 	 	 	9/ DISCOUNT FOR PROMPT PAYMENT
	     38 Sidney Street

	 	 	 	N/A	 	 
	     Cambridge, MA 02139
	 	 	 	 	 	 
	 	 	 	 	 
	 

	 	 	 	10. SUBMIT INVOICES
	 	ITEM
	 	 	 	 	 
	CODE

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

	 	 	 	 	 	 	 	 	 	 	 
	11. SHIP TO/MARK FOR

	 	CODE
	 	N/A
	 	12. PAYMENT WILL BE MADE BY
	 	CODE
	 	N/A
	 

	 	 	 	 
	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	     Article F.1.

	 	 	 	 	 	     See Article G.3.	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 
	13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: N/A

	 	14. ACCOUNTING AND APPROPRIATION DATA      ADB # N01-AI-40071
	      o 10 U.S.C. 2304(c)(   )            o 41 U.S.C. 253(c)(   )

	 	   EIN# *****    SOC# ****    04: $ *****    CAN# 4-8460924
	 
	 	 
	 

	 	 	 	 	 	 	 	 	 	 	 
	15A. ITEM NO.

	 	15B. SUPPLIES/SERVICES
	 	15C. UNIT PRICE
	 	15D. AMOUNT
	 	15E. UNIT PRICE
	 	15F. AMOUNT
	 

	 	 	 	 	 	 	 	 	 	 	 
	Title:

	 	FY 04
	 	$*****
	 	 
	 	 	 	 
	Production and Testing of a Modified Vaccinia Ankara (MVA) Vaccine

	 	FY 05
	 	*****	 	 	 	 	 	 
	Period: September 30, 2004 through September 29, 2007
	 	 	 	 	 	 	 	 	 	 
	Amount Allotted: *****
	 	 	 	 	 	 	 	 	 	 
	Contract Type: Cost reimbursement/Completion
	 	 	 	 	 	 	 	 	 	 
	 
	 	 	15G. TOTAL AMOUNT OF CONTRACT      4	 	$*****	 	 
	 

16. TABLE OF CONTENTS
 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	þ	 	SEC.	 	DESCRIPTION	 	PAGE(S)	 	þ	 	SEC.	 	DESCRIPTION	 	PAGE(S)
	 
	 

	 	 	 	PART I — THE SCHEDULE
	 	 	 	 	 	 	 	 	 	PART II — CONTRACT CLAUSES	 	 	 	 
	 
	x

	 	A
	 	SOLICITATION/CONTRACT FORM
	 	 	1	 	 	x
	 	I
	 	CONTRACT CLAUSES
	 	 	20	 
	 
	x	 	B	 	SUPPLIES OR SERVICES AND PRICE/COST	 	 	4	 	 	PART III — LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

	 
	x

	 	C
	 	DESCRIPTION/SPECS./WORK STATEMENT
	 	 	7	 	 	x
	 	J
	 	LIST OF ATTACHMENTS
	 	 	26	 
	 
	x

	 	D
	 	PACKAGING AND MARKING
	 	 	9	 	 	 	 	 	 	PART IV — REPRESENTATIONS AND INSTRUCTIONS	 	 	 	 
	 
	x

	 	E
	 	INSPECTION AND ACCEPTANCE
	 	 	9	 	 	x
	 	K
	 	REPRESENTATIONS, CERTIFICATIONS
	 	 	27	 
	 	 	 	 	 	 	 	 	 	 	 
	x

	 	F
	 	DELIVERIES OR PERFORMANCE
	 	 	10	 	 	 	 	 	 	AND OTHER STATEMENTS OF OFFERORS	 	 	 	 
	 
	x

	 	G
	 	CONTRACT ADMINISTRATION DATA
	 	 	11	 	 	o
	 	L
	 	INSTRS., CONDS., AND NOTICES TO OFFERORS	 	 	 	 
	 
	x

	 	H
	 	SPECIAL CONTRACT REQUIREMENTS
	 	 	14	 	 	o
	 	M
	 	EVALUATION FACTORS FOR AWARD	 	 	 	 
	 

CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
 

	 	 	 
	17. x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and
return _2___copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services
set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights
and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this
award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and
specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)

	 	18. AWARD o (Contractor is not required to sign this document.) Your offer on Solicitation Number
                                        , including the additions or changes made by you which additions or changes are set forth in full above, is hereby
accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents:
(a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document is necessary.
	 
	 	 
	 

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

	 	20A. NAME OF CONTRACTING OFFICER	 	 	 	 
	 

	 	Janet M. Mattson	 	 	 	 
	 

	 	Contracting Officer, VRCB, CMP, NIAID, NIH, DHHS	 	 	 	 
	 

	 	 	 	 	 	 	 
	19B. NAME OF CONTRACTOR

	 	19C. DATE SIGNED
	 	20B. UNITED STATES OF AMERICA
	 	20C. DATE SIGNED
	 
	 	 	 	 	 	 
	                                                  

	 	 	 	BY                                         	 	 

	 	 	 	 	 	 	 
	(Signature of person authorized to sign)

	 	 
	 	(Signature of Contracting Officer)
	 	 
	 

	 	 	 	 	 
	NSN 7540-01-152-8069

	 	26-107
	 	STANDARD FORM 26 (REV. 4-85)
	PREVIOUS EDITION UNUSABLE

	 	Computer Generated
	 	Prescribed by GSA
	 

	 	 	 	FAR (48 CFR) 53.214(a)

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

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
	 	 	7	 
	ARTICLE C.1. STATEMENT OF WORK
	 	 	7	 
	ARTICLE C.2. REPORTING REQUIREMENTS
	 	 	7	 
	ARTICLE C.3. INVENTION REPORTING REQUIREMENT
	 	 	8	 
	 
	 	 	 	 
	SECTION D — PACKAGING, MARKING AND SHIPPING
	 	 	9	 
	 
	 	 	 	 
	SECTION E — INSPECTION AND ACCEPTANCE
	 	 	9	 
	 
	 	 	 	 
	SECTION F — DELIVERIES OR PERFORMANCE
	 	 	10	 
	ARTICLE F.1. DELIVERIES
	 	 	10	 
	ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE
	 	 	11	 
	 
	 	 	 	 
	SECTION G — CONTRACT ADMINISTRATION DATA
	 	 	11	 
	ARTICLE G.1. PROJECT OFFICER
	 	 	11	 
	ARTICLE G.2. KEY PERSONNEL
	 	 	12	 
	ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
	 	 	12	 
	ARTICLE G.4. INDIRECT COST RATES
	 	 	12	 
	ARTICLE G.5. GOVERNMENT PROPERTY
	 	 	13	 
	ARTICLE G.6. POST A WARD EVALUATION OF CONTRACTOR PERFORMANCE
	 	 	13	 
	 
	 	 	 	 
	SECTION H — SPECIAL CONTRACT REQUIREMENTS
	 	 	14	 
	ARTICLE H.1. REIMBURSEMENT OF COSTS FOR INDEPENDENT RESEARCH AND DEVELOPMENT PROJECTS
	 	 	14	 
	ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS
	 	 	14	 
	ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS
	 	 	14	 
	ARTICLE H.4. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
	 	 	15	 
	ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
	 	 	15	 
	ARTICLE H.6. NEEDLE EXCHANGE
	 	 	15	 
	ARTICLE H.7. PRIVACY ACT
	 	 	16	 
	ARTICLE H.8. ANIMAL WELFARE
	 	 	16	 
	ARTICLE H.9. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS
	 	 	16	 
	ARTICLE H.10. OPTION PROVISION
	 	 	16	 
	ARTICLE H.11. SALARY RATE LIMITATION LEGISLATION PROVISIONS
	 	 	16	 
	ARTICLE H.12. PUBLICATION AND PUBLICITY
	 	 	17	 
	ARTICLE H.13. PRESS RELEASES
	 	 	17	 

2

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

	 	 	 	 	 
	ARTICLE H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
	 	 	17	 
	ARTICLE H.15. ANTI -LOBBYING
	 	 	18	 
	ARTICLE H.16. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES
	 	 	18	 
	ARTICLE H.17. SHARING RESEARCH DATA
	 	 	18	 
	ARTICLE H.18. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
	 	 	19	 
	ARTICLE H.19. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
	 	 	19	 
	 
	 	 	 	 
	PART II — CONTRACT CLAUSES
	 	 	20	 
	 
	 	 	 	 
	SECTION I — CONTRACT CLAUSES
	 	 	20	 
	 
	 	 	 	 
	ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT
	 	 	21	 
	ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES
	 	 	24	 
	ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES
	 	 	24	 
	ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
	 	 	25	 
	 
	 	 	 	 
	PART III
	 	 	26	 
	 
	 	 	 	 
	SECTION J — LIST OF ATTACHMENTS
	 	 	26	 
	1. Statement of work, 4 pages
	 	 	26	 
	2. Invoice/financing request and contract financial reporting instructions
for NIH Cost-Reimbursement Type Contracts
	 	 	26	 
	3. Inclusion Enrolment Report
	 	 	26	 
	4. Privacy Act System of Records
	 	 	26	 
	5. Safety and Health
	 	 	26	 
	6. Procurement of Certain Equipment
	 	 	26	 
	7. Research Patient Care Costs
	 	 	26	 
	 
	 	 	 	 
	PART IV
	 	 	27	 
	 
	 	 	 	 
	SECTION K — REPRESENTATIONS AND CERTIFICATIONS
	 	 	27	 
	1. Representations and Certifications
	 	 	27	 
	2. Human Subjects Assurance Identification Number
	 	 	27	 
	3. Animal Welfare Assurance Number
	 	 	27	 

3

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

SECTION B — SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this contract is to manufacture, fill, finish, and release 500,000 doses of a
Modified Vaccinia Ankara (MV A) vaccine, with an option for an additional 2.5 million doses, from
at least two additional cGMP consistency lots within the first two years of award. The vaccine
shall be of a quality suitable for a path to licensure in the U.S. The third year of the contract
will allow for preclinical study and clinical trial follow-up, maintenance and storage of the
vaccine inventory, and stability testing.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

	a.	 	The estimated cost of the Base portion of this contract is $*****.
	 
	b.	 	The fixed fee for the Base portion of this contract is $*****. The fixed fee shall be paid in
instalments based on the percentage of completion of work, as determined by the Contracting
Officer. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST
AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE 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 the fixed fee
for the Base portion of this contract $76,283,309.
	 
	d.	 	If the Government exercises its option pursuant to ARTICLE H.10. of this contract, the
Government’s total obligation represented by the sum of the estimated cost plus the fixed fee
will be increased as follows:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Estimated Cost	 	Fixed Fee	 	Estimated Cost Plus
	 	 	 	 	 	 	Fixed Fee
	Base Period
	 	*****	 	*****	 	$	*****
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Option Period
	 	*****	 	*****	 	$	*****
	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Total Base Period
and Option
	 	*****	 	*****	 	$	*****

	e.	 	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. For further
provisions on funding, see the LIMITATION OF FUNDS clause referenced in Part II, ARTICLE 1.2.
Authorized Substitutions of Clauses.

	f.	 	It is estimated that the amount currently allotted will cover performance of the contract
through September 29, 2005.

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

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

	a.	 	Items Unallowable Unless Otherwise Provided
	 
	 	 	Notwithstanding the clauses, ALLOW ABLE 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:

4

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

	(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)	 	Consultant costs;
	 
	(6)	 	Subcontracts;
	 
	(7)	 	Patient care costs;
	 
	(8)	 	Accountable Government property (defined as both real and personal property with an
acquisition cost of $1,000 or more and a life expectancy of more than two years) and
“sensitive items” (defined and listed in the Contractor’s Guide for Control of Government
Property), 1990, regardless of acquisition value.
	 
	b.	 	Travel Costs
	 
	(1)	 	Domestic Travel

	 	(a)	 	Total expenditures for domestic travel (transportation, lodging, subsistence,
and incidental expenses) incurred in direct performance of this contract shall not
exceed ***** without the prior written approval of the Contracting Officer.
	 
	 	(b)	 	The Contractor shall invoice and be reimbursed for all travel costs in
accordance with Federal Acquisition Regulations (FAR) 31.205-46.

	(2)	 	Foreign Travel

	 	(a)	 	Total expenditures for foreign 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 for 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/cost reimbursement type subcontract with Baxter Healthcare
SA to develop, formulate, purify, document and qualify appropriate downstream processing and
other necessary procedures and Quality Control testing, in process testing, and stability testing
for a MV A vaccine. The subcontractor shall document the process to manufacture MV A vaccine and
manufacture, fill, and finish, and deliver 500,000 doses with an option for an additional 2.5
million doses and other items set forth in Section B of the subcontract agreement. The amount shall
not exceed ***** for the Base period (Milestones 1-11, 15-18) and ***** for the Option (Milestones
12-14) for a Total Amount of *****.

5

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

	b.	 	Subcontract

Funds in the amount of ***** for the Base period (Milestones I-II, 15-18) and ***** for the Option
(Milestones 12-14) for a Total Amount of ***** are set aside for anticipated fixed price or cost
reimbursement type subcontracts with various organizations. Award of each 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. A draft subcontract shall be submitted for review by the Contracting Officer. After
written approval of the subcontract by the Contracting Officer, a copy of the signed, approved
subcontract shall be provided to the Contracting Officer.

	c.	 	Consultants

Consultant fees to be paid to the following individuals:

	 	 	 	 	 	 	 	 	 
	Name	 	Area	 	Rate	 	Total Cost	 	Not to Exceed
	Kathleen Kirby

	 	Clinical Consulting
	 	*****
	 	*****	 	 
	Foresight
Regulatory
Strategies, Inc.

	 	Regulatory Consulting
	 	*****
	 	*****	 	 
	Raif Geha

	 	Mouse Model
	 	*****
	 	*****	 	 
	Martin Hirsch

	 	Clinical Design
	 	*****
	 	*****	 	 
	Peter Jahrling

	 	Primate Study Design
	 	*****
	 	*****	 	 
	Donald Leung

	 	Clinical Design
	 	*****
	 	*****	 	 
	Data Safety

Monitoring Board

	 	Review
	 	*****
	 	*****	 	 

 

	*	 	Plus Travel
	 
	**	 	Plus expenses

	d.	 	Confidential Treatment of Sensitive Information

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

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after
the Contractor receives prior written approval from the Contracting Officer. Whenever the
Contractor is uncertain with regard to the proper handling of information/data under the contract,
the Contractor shall obtain a written determination from the Contracting Officer.

	e.	 	Contract Number Designation

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

	 	 	 	Contract No. HHSN26620040007lC

ADB Contract No. NOl-AI-4007l

	f.	 	Protocol Approval

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

6

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

clinical protocol that has not received the written approval of the NIAID Project Officer shall not
be reimbursed through this contract.

	g.	 	Clinical Exemption Committee

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.

	h.	 	Indirect Rate Agreement

The Contractor proposed rates of Fringe: *****; Overhead: ***** (Cambridge) and ***** (Canton); and
G&A: ***** were used for negotiation purposes. Documentation supporting these rates shall be
provided to the Division of Financial Advisory Services, NIH, at the address set forth in Article
GA. within six months of award. Failure to provide this documentation shall result in suspension of
indirect cost reimbursement until a formal rate agreement has been executed.

SECTION C — DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

	a.	 	Independently and not as an agent of the Government, the Contractor shall furnish all the
necessary services, qualified personnel, material, equipment, and facilities, not otherwise
provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT
I, dated September 30,2004, attached hereto and made apart of this contract.

ARTICLE C.2. REPORTING REQUIREMENTS

In addition to those reports required by the other terms of this contract, the Contractor shall
prepare and submit the following reports in the manner stated below and in accordance with ARTICLE
F.1. DELIVERIES of this contract:

	a.	 	Technical Reports

	 	1.	 	Monthly Technical Progress Reports On the fifteenth of each month for
the previous calendar month, the Contractor shall submit three (3) copies of a Monthly
Technical Progress Report, comprising two (2) copies to the Project Officer and one (I)
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-A listing of any and all deliverables submitted
during the previous month, a listing of any and all relevant administrative
items occurring in the previous months, a listing of all meetings held and
meeting minutes submitted during the previous month, a brief summary of
financial status of the Contract, and 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 and shall be organized by
Milestones. 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 one-page 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.

7

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

	 	d.	 	SECTION III-Substantive performance; a description of current technical
or substantive performance and any problems encountered and/or which may exist
along with 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. Also to be included in
the report is a summary of any significant decisions taken/pending and
concerns/strategies needing to be addressed.

	 	2.	 	Annual Technical Progress Report for Clinical Research Study Populations The
Contractor shall submit information about the inclusion of women and members of minority
groups and their subpopulations for each study being performed under this contract. The
contractor shall submit this information in the format indicated in the attachment
entitled, “Inclusion Enrolment Report,” which is set forth in Section J of this contract.
The contractor also shall use this format, modified to indicate that it is a final report,
for reporting purposes in the final report. The contractor shall submit the report in
accordance with ARTICLE F.1. DELIVERIES of this contract. In addition, the NIH Policy and
Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research,
Amended, October, 2001 applies.

If this contract is for Phase III clinical trials, see ILB of these guidelines. The
Guidelines may be found at the following website:

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

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

	 	3.	 	Final Report By the expiration date of the contract, the Contractor shall
submit three (3) copies of a comprehensive Final Report, as above, comprising two (2)
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. The Final Report shall be submitted
in accordance with ARTICLE F.1 DELIVERIES of this contract. An annual report will not be
required for the period when the Final Report is due.

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

	b.	 	Deliverables

	 	 	 	The following are considered deliverables under this contract:
	 
	 	1.	 	All Technical Reports, Milestone Reports, preprints, and protocols as described in the
Statement of Work. These deliverables are due as indicated in ARTICLE F.l DELIVERIES of
this contract.
	 
	 	2.	 	All milestones indicated in the Statement of Work, including the following plans for
specific milestones: Product Development Plan (Milestone 1); Quality Systems Plan
(Milestone 2); Clinical Testing Plan (Milestone 3); Animal Testing Plan (Milestone 4);
Regulatory Support Plan (Milestone 5); Summary Report (Milestone 6); Large-Scale Production
Plan (Milestone 9); Interim Clinical Trial Report (Milestone 10); and Interim Animal
Studies Report (Milestone 11).

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,

8

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

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 on the expiration date of the contract.

The final invention statement (see FAR 27.303(a)(2)(ii» shall be submitted on the expiration date
of the contract to the following address:

	 	 	 	Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases, CMP

6700B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892 — 7612

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

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

SECTION D — PACKAGING, MARKING AND SHIPPING

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

SECTION E — INSPECTION AND ACCEPTANCE

	a.	 	The Contracting Officer or the duly authorized representative will perform inspection and
acceptance of materials and services to be provided.
	 
	b.	 	For the purpose of this SECTION, the Project Officer is the authorized representative of the
Contracting Officer.
	 
	c.	 	Inspection and acceptance will be performed at the address listed in Article G .1.
	 
	 	 	Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer
or the duly authorized representative within 30 days of receipt.
	 
	d.	 	This contract incorporates the following clause by reference, with the same force and effect
as if it were given in full text. Upon request, the Contracting Officer will make its full
text available.
	 
	 	 	FAR Clause No 52.246-8, INSPECTION OF RESEARCH AND DEVELOPMENT — COST REIMBURSEMENT (MAY
2001).

9

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

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.I. and upon delivery and acceptance by the Contracting Officer, or the
duly authorized representative, of the following items in accordance with the stated delivery
schedule:

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

	 	 	 	 	 	 	 	 	 
	 	 	No.	 	 	 	 
	Type of Report	 	Copies	 	Addressee	 	Due Dates
	Monthly Progress Report

	 	 	3	 	 	Project Officer

NIH/NIAID/DMID

6610 Rockledge Drive

Room 5121, MSC 6604

Bethesda, MD 20892-6604
	 	On 15th of
each month for the
previous calendar month
	 
	 	 	 	 	 	 	 	 
	Monthly Progress Report

	 	 	1	 	 	Contracting Officer

NIH/NIAID/CMP

6700B Rockledge Drive

Room 3214, MSC 7612

Bethesda, MD 20892-7612
	 	Same as above
	 
	 	 	 	 	 	 	 	 
	Technical Progress Report for Clinical
 Research Study Populations

	 	 	2	 	 	Project Officer (above)
	 	Annually on contract

anniversary date
	 
	 	 	 	 	 	 	 	 
	Final Report

	 	 	3	 	 	Project Officer (above)
	 	Contract expiration date
	 
	 	 	 	 	 	 	 	 
	Final Report

	 	 	1	 	 	Contracting Officer (above)
	 	Contract expiration date
	 
	 	 	 	 	 	 	 	 
	Summary of Salient Results

	 	 	3	 	 	Project Officer (above)
	 	Contract expiration date

	b.	 	In addition to the above, the following are deliverables under this contract. If the
Government exercises its option pursuant to Article H.I 0 of this contract, the quantity will
be increased as listed below:

	 	 	 	 	 	 	 	 	 
	Item	 	Description	 	Quantity	 	Delivery Schedule
	Contract Base

	 	Single Dose of MVA
Vaccine
	 	500,000	 	Within 11 months of
contract award
	 
	 	 	 	 	 	 	 	 
	Contract Option

	 	Singles Doses of
MVA Vaccine
	 	Up to 2,500,000
	 	As directed

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

	 	 	 	 	 
	Item	 	Addressee	 	Quantity
	 	 	 	 	 
	Contract Base

	 	To be identified by the Project Officer
	 	500,000 single doses
	Contract Option

	 	To be identified by the Project Officer
	 	Up to 2,500,000 single doses

10

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

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.arnetgov/far/.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER I) 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 Officers will represent the Government for the purpose of this contract:

Gerald R. Kovacs, Ph.D.

Senior Project Officer

Product Development Section

Office of Biodefense Research Affairs (OBRA)

Division of Microbiology and Infectious Diseases (DMID) National Institute

of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)

6610 Rockledge Drive

Room 5121, MSC 6604

Bethesda, MD 20892-6604

(Zip for express mail is 20817)

Phone: (301) 451-3511, (301) 402-4197

FAX: (301) 480-1263

gkovacs@niaid.nih.gov

Nancy Joie Watkins, M.S.

Alternate Project Officer

Product Development Section

Office of Biodefense Research Affairs (OBRA)

Division of Microbiology and Infectious Diseases (DMID) National Institute

of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH)

6610 Rockledge Drive

Room 5004, MSC 6604

Bethesda, MD 20892-6604

(Zip for express mail is 20817)

Phone: (301) 451-6755 FAX: (301) 480-1263
nwatkins@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.

11

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

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: (I) 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 Government may unilaterally change its Project Officer designation.

ARTICLE G.2. KEY PERSONNEL

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

	 	 	 
	Name	 	Title
	 
	Cynthia K. Lee, Ph.D.
	 	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 IDISAR 342.7002.

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

	 	(a)	 	To be considered a “proper” invoice in accordance with FAR
32.9, each invoice shall clearly identify the two contract numbers that appear
on the face page of the contract as follows:
	 
	 	 	 	Contract No. IDISN266200400071C

ADB Contract No. NOI-AI-40071
	 
	 	(b)	 	An original and two copies to the following designated billing office:
	 
	 	 	 	Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious Diseases, CMP

6700B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892 -7612

	 	(2)	 	Inquiries regarding payment of invoices should be directed to the designated
billing office, (301) 496-0612.
	 
	 	(3)	 	 

ARTICLE G.4. INDIRECT COST RATES

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

12

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

	 	 	 	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

601 I 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.

ARTICLE G.6. POST A WARD 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, an interim evaluation will be prepared
mid-point in the contract 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

13

 

Contract No. HHSN26620040071C

ADB Contract No. NOI-AI-40071

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. 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-OO-O39.html.

The information below is a summary of the NIH Policy Announcement:

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

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

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

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

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

http://grants.nih.gov/grants/guide/notice-files/not99-l 07 .html

http://grants.nih.gov/grants/guide/notice-files/N OT -OD-00-03 8.html

14

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

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

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

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

ARTICLE H.4. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

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

The Contractor shall provide written documentation that all human materials obtained as a result of
research involving human subjects conducted under this contract, by collaborating sites, or by
subcontractors identified under this contract, were obtained with prior approval by the Office for
Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to
protect human research subjects. This restriction applies to all collaborating sites without
OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the
Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed “Protection of Human
Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No.
0990-0263 (formerly Optional Form 3 10), certifying IRB review and approval of the protocol from
which the human materials were obtained constitutes the written documentation required. The human
subject certification can be met by submission of a self designated form, provided that it contains
the information required by the “Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310)

ARTICLE H.5. 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 (I)
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. 108-199, Title V-General Provisions,                       2004                                 10/1/03-9/30/04

Section 510

ARTICLE H.6. NEEDLE EXCHANGE

	a.	 	Pursuant to Public Law 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.

15

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	b.	 	Public Law and Section No.                                          Fiscal Year                                           Period Covered
	 
	 	 	P.L. 108-199, Title V-General Provisions,                       2004                                 10/1/03-9/30/04

Section 505

ARTICLE H.7. 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 is
incorporated into this contract as Attachment 4.

ARTICLE H.8. 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.9. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS

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

ARTICLE H.10. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in ARTICLE I.3.,
the contract will consist only of the Base of the Statement of Work as defined in Sections C and F
of the contract. Pursuant to clause 52.217-7 set forth in ARTICLE I.3. of this contract, the
Government may, by unilateral contract modification, require the Contractor to deliver additional
doses of MVA in accordance with the Statement of Work as also defined in Sections C and F of the
contract. If the Government exercises this option, notice must be given at least 60 days prior to
the expiration date of this contract, and the estimated cost plus fixed fee of the contract will be
increased as set forth in ARTICLE B.2.

ARTICLE H.11. 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.

16

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	 	 	 	 	 	 	 	 	 
	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 I
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 I rate is $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.)

ARTICLE H.12. 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. HHSN266200400071C, ADB Contract No.
NOI-AI-40071.”

ARTICLE H.13. 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: (l)
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 non-governmental sources.

	 	 	 	 	 	 	 	 	 
	b.
	 	 	 	 	 	 	 	 
	 

	 	Public Law No.
	 	Fiscal Year
	 	Period Covered
	 

	 	P.L. 108-199, Title V-General Provisions,
	 	 	2004	 	 	10/1/03 — 9/30/04
	 

	 	Section 507	 	 	 	 	 	 

ARTICLE H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

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

Office of Inspector General

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Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

Department of Health and Human Services TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

ARTICLE H.15. ANTI -LOBBYING

	a.	 	Pursuant to Public Law(s) cited in paragraph c., below, contract funds shall only be used for
normal and recognized executive-legislative relationships. Contract funds shall not be used,
for publicity or propaganda purposes; or 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-
	 	 	2004	 	 	10/1/03 — 9/30/04
	 

	 	      General Provisions, Section 503a	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	for b., above: P.L. 108-199, Title V-	 	 	 	 	 	 
	 

	 	      General Provisions, Section 503b
	 	 	2004	 	 	10/1/03 — 9/30/04

ARTICLE H.16. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

Unique research resources arising from NTH-funded research are to be shared with the scientific
research community. NTH 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.17. SHARING RESEARCH DATA

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

The NIH endorses the sharing of final research data to expedite the translation of research results
into knowledge, products, and procedures to improve human health. this contract is expected to
generate research data that must be shared with the public and other researchers. NIH’s data
sharing policy may be found at the following Web site:

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

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

18

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

ARTICLE H.18. 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 agents.

For prime or subcontract awards to domestic institutions who possess, use, and/or transfer Select
Agents under this contract, the institution must complete registration with the Centers for Disease
Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and
Plant Health Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as applicable,
before using NIH funds for research involving Select Agents. No NIH funds can be used for research
involving Select Agents if the final registration certificate is denied.

For prime or subcontract awards to foreign institutions who possess, use, and/or transfer Select
Agents under this contract, the institution must provide information satisfactory to the NIH that a
process equivalent to that described in 42 CFR 73
(http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for
U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored
by these funds before using these funds for any work directly involving the Select Agents. The
contractor must provide information addressing the following key elements appropriate for the
foreign 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. An NIAID-chaired committee of U.S. federal
employees (including representatives of NIH grants/contracts and scientific program management, CDC, Department of Justice and other federal intelligence agencies, and Department of State) will
assess the policies and procedures for comparability to the U.S. requirements described in 42 CFR
Part 73. When requested by the contracting officer, the contractor should provide key information
delineating any laws, regulations, policies, and procedures applicable to the foreign institution
for the safe and secure possession, use, and transfer of Select Agents. This includes concise
summaries of safety, security, and training plans, and applicable laws, regulations, and policies.
For the purpose of security risk assessments, the contractor must provide the names of all
individuals at the foreign institution who will have access to the Select Agents and procedures for
ensuring that only approved and appropriate individuals have access to Select Agents under the
contract. 

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/ 

ARTICLE H.19. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

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

19

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

PART II — CONTRACT CLAUSES

SECTION I — CONTRACT CLAUSES

20

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

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.amet.gov/far/.

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

	 	 	 	 	 
	FAR	 	 	 	 
	 CLAUSE	 	 	 	 
	NO	 	DATE	 	TITLE
	52.202-1

	 	Jul 2004
	 	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)
	 
	 	 	 	 
	52.204-7

	 	Oct 2003
	 	Central Contractor Registration
	 
	 	 	 	 
	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

	 	Jan 2004
	 	Pension Adjustments and Asset Reversions
	 
	 	 	 	 
	52.215-18

	 	Oct 1997
	 	Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other
than Pensions
	 
	 	 	 	 
	52.215-19

	 	Oct 1997
	 	Notification of Ownership Changes
	 
	 	 	 	 
	52.215-21

	 	Oct 1997
	 	Requirements for Cost or Pricing Data or Information Other Than Cost or

Pricing Data – Modifications
	 
	 	 	 	 
	52.216-7

	 	Dec 2002
	 	Allowable Cost and Payment

21

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	 	 	 	 	 
	FAR	 	 	 	 
	 CLAUSE	 	 	 	 
	NO	 	DATE	 	TITLE
	52.216-8

	 	Mar 1997
	 	Fixed Fee
	 
	 	 	 	 
	52.219-8

	 	May 2004
	 	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

	 	Ju1 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

	 	Aug 2003
	 	Toxic Chemical Release Reporting (Over $100,000)
	 
	 	 	 	 
	52.225-1

	 	Jun 2003
	 	Buy American Act – Supplies
	 
	 	 	 	 
	52.225-13

	 	Dec 2003
	 	Restrictions on Certain Foreign Purchases
	 
	 	 	 	 
	52.225-1

	 	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 (t) is modified to include the requirements in
FAR 27.303(a)(2)(i) through (iv). The frequency of reporting in (i) is annual.
	 
	 	 	 	 
	52.227-14

	 	Jun 1987
	 	Rights in Data — General
	 
	 	 	 	 
	52.232-9

	 	Apr 1984
	 	Limitation on Withholding of Payments
	 
	 	 	 	 
	52.232-17

	 	Jun 1996
	 	Interest (Over $100,000)
	 
	 	 	 	 
	52.232-20

	 	Apr 1984
	 	Limitation of Cost
	 
	 	 	 	 
	52.232-23

	 	Jan 1986
	 	Assignment of Claims
	 
	 	 	 	 
	52.232-25

	 	Oct 2003
	 	Prompt Payment, Alternate I (Feb 2002)
	 
	 	 	 	 
	52.232-33

	 	Oct 2003
	 	Payment by Electronic Funds Transfer—Central Contractor Registration
	 
	 	 	 	 
	52.233-1

	 	Jul 2002
	 	Disputes
	 
	 	 	 	 
	52.233-3

	 	Aug 1996
	 	Protest After Award, Alternate I (Jun 1985)
	 
	 	 	 	 
	52.242-1

	 	Apr 1984
	 	Notice of Intent to Disallow Costs

22

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	 	 	 	 	 
	FAR	 	 	 	 
	 CLAUSE	 	 	 	 
	NO	 	DATE	 	TITLE
	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

	 	May 2004
	 	Government Property (Cost-Reimbursement, Time and Material, or Labor-Hour
Contract)
	 
	 	 	 	 
	52.246-23

	 	Feb 1997
	 	Limitation of Liability (Over $100,000)
	 
	 	 	 	 
	52.249-6

	 	Sep 1996
	 	Termination (Cost-Reimbursement)
	 
	 	 	 	 
	52.249-14

	 	Apr 1984
	 	Excusable Delays
	 
	 	 	 	 
	52.253-1

	 	Jan 1991
	 	Computer Generated Forms

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

	 	 	 	 	 
	HHSAR 	 	 	 	 
	CLAUSE NO.	 	DATE	 	TITLE
	352.202-1

	 	Jan 2001
	 	Definitions — with Alternate paragraph (h) (Jan 2001)
	 
	 	 	 	 
	352.216-72

	 	Oct 1990
	 	Additional Cost Principles
	 
	 	 	 	 
	352.228- 7

	 	Dec 1991
	 	Insurance — Liability to Third Persons
	 
	 	 	 	 
	352.232-9

	 	Apr 1984
	 	Withholding of Contract Payments
	 
	 	 	 	 
	352.233-70

	 	Apr 1984
	 	Litigation and Claims
	 
	 	 	 	 
	352.242-71

	 	Apr 1984
	 	Final Decisions on Audit Findings
	 
	 	 	 	 
	352.270-5

	 	Apr 1984
	 	Key Personnel
	 
	 	 	 	 
	352.270-6

	 	Ju1 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. 07/2004].

23

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

ARTICLE I.2 AUTHORIZED SUBSTITUTION OF CLAUSES

ARTICLE 1.1. 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 therefore. Note: When this contract is fully
funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no longer apply and FAR Clause 52.232-20,
LIMITATION OF COST will become applicable.

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

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

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

	 	(1)	 	FAR 52.215-17, Waiver of Facilities Capital Cost of Money (OCTOBER 1997).
	 
	 	(2)	 	FAR 52.217-7, Option for Increased Quantity — Separately Priced Line Item
(MARCH 1989).
	 
	 	 	 	“The Contracting Officer may exercise the option by written notice to the Contractor
within 60 days prior to the expiration of this contract”
	 
	 	(3)	 	FAR 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (JANUARY 1999).

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

	 	 	 	o Offeror elects to waive
the evaluation preference. ”

	 	(4)	 	FAR 52.224-1, Privacy Act Notification (APRIL 1984).
	 
	 	(5)	 	FAR 52.224-2, Privacy Act (APRIL 1984).
	 
	 	(6)	 	FAR 52.229-8, Taxes-Foreign Cost-Reimbursement Contracts (MARCH 1990).
	 
	 	(7)	 	FAR 52.242-3, Penalties for Unallowable Costs (MAY 2001).

	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 JATTACHMENTS.]
	 
	 	(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)	 	HHSARS 352.270-9, Care of Live Vertebrate Animals (JANUARY 2001).

24

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	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)-II, Research Patient Care Costs (4/1/84).

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

This contract incorporates the following clauses in full text.

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

	a.	 	FAR Clause 52.244-6, SUBCONTRACTS FOR COMMERCIAL ITEMS (July 2004)

	 	(a)	 	Definitions. As used in this clause-
	 
	 	 	 	Commercial item, has the meaning contained in Federal Acquisition Regulation
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 no
developmental 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 (MAY 2004) (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.

25

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

PART III

SECTION J — LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

	1.	 	Statement of Work, 4 pages.
	 
	2.	 	Invoice/Financing Request and Contract Financial Reporting Instructions for NIH
Cost-Reimbursement Type Contracts, NIH(RC)-4, (5/97), 6 pages.
	 
	3.	 	Inclusion Enrolment Report, 5101 (Modified OAMP: 10/01), 1 page.
	 
	4.	 	Privacy Act System of Records, Number 09-25-0200. A copy may be obtained at the following
website: http://oma.od.nih.goy/ms/oriyacv/oa-files/0200.htm
	 
	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, i page.

26

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

PART IV

SECTION K — REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

	1.	 	Representations and Certifications, dated February 2, 2004.
	 
	2.	 	Human Subjects Assurance Identification Number for Acambis, Inc.: FWA0001573, dated December
7, 2001.
	 
	3.	 	Animal Welfare Assurance Number for Acambis, Inc.: A3924-10.

END of the SCHEDULE

(CONTRACT)

27

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

STATEMENT OF WORK

Production and Testing of a Modified Vaccinia Ankara (MVA) Vaccine

Independently, and not as agent of the U.S. Government, the Contractor shall furnish all the
necessary services, qualified personnel, material, equipment, and facilities not otherwise provided
by the U.S. Government, as needed to perform the work described below.

BASE PORTION

	1.	 	Milestone I-Product Development Plan: Within 2 months of contract award submit a
Product Development Plan (PDP) that is integrated with the quality, testing, and regulatory
plans. Activities in this plan, for both the Active Phannaceutical Ingredient (API) and
final dosage fonD, shall focus on the following: (a) development, scale-up and validation
of the manufacturing processes; (b) development optimization, and qualification/validation
of the test methods necessary for product characterization, release testing, stability
testing, and potency evaluation; and ( c) stability studies for each fonnulation and
container/closure. The PDP shall include all planned development activities including GMP
as well as non-GMP studies. Timing of these activities relative to the manufacture of up to
3 million doses of MVA vaccine, as well as ultimate FDA licensure of the product (although
not a requirement of this RFP), should be stated. Development, validation and stability
programs must comply with current regulations and relevant FDA and ICG guidance documents.
	 
	 	 	The NIAID is requesting that the API be at a concentration of 1 x 108
TCID50 per dose, and the final dosage form be in a liquid formulation.
	 
	2.	 	Milestone 2-Quality Systems Plan: Within 3 months of contract award submit a Quality
Systems Plan (QSP) that is integrated with the manufacturing, testing and regulatory plans.
Activities in this plan shall focus on cGMP compliance for the production and release of
both the Active Pharmaceutical Ingredient (API) and the up to 3 million doses of MVA. It
shall include appropriate documentation of cells and/or cell banks used, change control,
document control, environmental and utility monitoring, laboratory controls, maintenance
and calibration, materials management (including shipping), Quality management, equipment
qualification, computer validation, cleaning validation, production records (including
deviations), laboratory records (including out of specifications results), and training.
Quality systems must comply with current regulations and relevant FDA and ICH guidance
documents.
	 
	3.	 	Milestone 3-Clinical Testing Plan: Within 4 months of contract award submit a Clinical
Testing Plan (CTP) to licensure that is integrated with the animal testing, manufacturing
and regulatory plans using the most current and available information including
consultation with DMID, CBER and other experts in the field. Clinical trial activities
performed as a result of this solicitation shall include: (a) a dose-response trial in
healthy adult populations (male and female) which are vaccinia naive and previously
vaccinated against smallpox; (b) a safety and immunogenicity trial with a fixed effective
dose of MVA as determined in the dose-response trial; (c) a safety and immunogenicity trial
in subjects with diagnosed atopic dermatitis; and (d) a safety and immunogenicity trial in
subjects with HIV infection. At least one study shall include a healthy cohort( s) that may
be followed for at least two years. Unless otherwise specified, all MVA vaccinations shall
be administered via the subcutaneous route. Alternative routes of vaccine delivery will be
studied by the DMID during the course of this contract. Although Phase III trials are not a
requirement of this contract, the CTP shall include future plans for these studies.

	 	 	 	 	 
	Statement of Work

	 	ATTACHMENT 1	 	 
	September 30, 2004

	 	Page 1	 	 

 

 

Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	 	 	It is recommended that the dose-response clinical trial be initiated as soon as possible. It
is also expected that the Contractor shall provide the NIAID with all relevant information
and/or the ability to cross-reference an IND in order to support NIAID filing a U.S.
Government held IND. To facilitate rapid product development, the Contractor shall provide
NIAID with copies of all communications with FDA, and include NIAID staff in conference
calls with the FDA. For information regarding the filing of an IND see
http://www.fda.gov/cber/ind/ind.htrn.
	 
	 	 	Standardized protocols, characterized reagents, and validated assays shall be used in all
human trials. DMID will facilitate attaining necessary resources to ensure that
immunological assays of samples obtained from all clinical trials are evaluated using
standardized validated assays. The CTP shall include arrangements for delivery of clinical
trial samples to the DMID and/or its designee(s).
	 
	4.	 	Milestone 4-Animal Testing Plan: Within 5 months of contract award, submit an Animal
Testing Plan (ATP) to vaccine licensure that is directed towards meeting the requirements
of 21 CFR 601.91 (FDA Animal Rule) and that is integrated with the clinical testing,
manufacturing and regulatory plans using the most current and available information derived
from consultations with DMID, CBER, and other experts in the field. The ATP shall: (a) be
such that efforts and budget for all animal studies are “front-loaded” so that the maximum
amount of data are acquired within the first two years of the contract; (b) include a
description of the animal experiments (supporting and pivotal) that will be conducted to
study immunogenicity and efficacy, and ultimately support licensure under 21 CFR 601.91;
and (c) include a description of the assays (including a plan for validation) that will be
used to study both humoral and cell-mediated immunity.
	 
	 	 	The following is a list of points to consider in preparing the ATP: (a) an appropriate
animal model is chosen that will provide data of sufficient statistical significance or
greater to support licensure under 21 CFR 601.91; (b) a murine model is selected that
demonstrates protection against a lethal aerosol challenge by ectromelia virus; ( c) a
nonhuman primate model is utilized that is suitable for testing the efficacy of the vaccine
to protect against challenge with monkeypox virus; and (d) all pivotal studies leading
towards licensure are conducted using Good Laboratory Practices (GLP). These points to
consider are not meant to reflect official U.S. Government policy with regards to
fulfillment of the requirements of 21 CFR 601.91; they are provided as a minimal framework
for the ATP, and points for discussion with the CBER.
	 
	 	 	In addition to the animal experiments proposed in fulfillment
of 21 CFR 60 1.91, the ATP
shall include separate section describing a formal toxicology study plan suitably tailored
to measure the unique safety aspects of MVA. The Contractor shall initiate immunogenicity
and toxicity studies only upon Project Officer approval.
	 
	5.	 	Milestone 5-Regulatory Support Plan: Within 6 months of contract award submit a
Regulatory Support Plan (RSP) that is integrated with all testing and manufacturing
activities. Activities in this plan shall include Investigational New Drug (IND)
maintenance, communications with the CBER, and the compilation of data and materials that
will be required in the Biological License Application (ELA).
	 
	6.	 	Milestone 6-Summary Report: Within 8 months of contract award, or sooner if available,
provide a formal summary report to the DMID based on items described in the PDP and
QSP. The report shall document the quality assurance procedures, performance measures, and
quantitative performance targets associated with manufacture of up to 3 million doses of
MVA vaccine. The Contractor shall demonstrate to the DMID that the final production
facility is suitable for the manufacture of FDA-licensable MVA vaccine. The facility and
production processes shall be maintained at current Good Manufacturing Practice (cGMP)
standards throughout all manufacturing operations. Quality Control (QC) and Quality
Assurance (QA) programs must be in place and sufficient to ensure cGMP manufacture of up to
3 million doses of MVA vaccine product.

	 	 	 	 	 
	Statement of Work

	 	 	 	 
	September 30, 2004

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ADB Contract No. NOI-AI-40071

	 	 	Quality programs must be maintained at cGMP standards throughout all manufacturing
operations. Completion of this milestone is contingent upon a successful preproduction audit
to be conducted by the DMID and/or its designee(s).
	 
	7.	 	Milestone 7: Within II months of contract award, complete manufacture, test, fill,
finish, release, store and/or deliver to the NIAID 500,000 single doses of MVA. The
formulation, via]Jclosure of this vaccine shall be the same as that to be used to fulfill
Milestone 13. The manufacture of this lot of vaccine shall be accomplished using the
intermediate-scale technologies and procedures proposed in the Technical Section ofthe
Proposal, and its intended purpose is to provide vaccine for both Contractor and NIAID
sponsored clinical trials.
	 
	8.	 	Milestone 8: Within 12 months of contract award, refine and submit for DMID approval, a
plan to maintain, test and replenish the MVA vaccine inventory for the period of
the contract. This milestone pertains to all activities required to maintain the vaccine
inventory.
	 
	9.	 	Milestone 9-Large-Scale Production Plan: Within 12 months of contract award, provide a
Large-scale Production Plan (LPP) to manufacture, formulate, fill/finish, test, and deliver
to the U.S. Government up to 50 million doses of the candidate MVA vaccine suitable for
storage in a stockpile for emergency use. The purpose of the LPP is to demonstrate
suitability to the U.S. Government as a supplier of MVA vaccine should the immediate need
arise. The LPP shall be based on production of a stockpile produced from multiple,
consistent, cGMP vaccine production campaigns, if needed. The plan shall include steps to
be taken to monitor the quality of the vaccine product, and replenish the stockpile as
needed to maintain its ready availability for emergency use under IND. The LPP shall
include: (a) details of the process to scale-up production of multiple lots, if needed; (b)
a timeline for production and delivery of up to 50 million doses of product; (c) a strategy
that will be pursued to seek a U.S. license for the product and to provide continued
support for maintaining an active government-held IND (this strategy shall be consistent
with, and refined from, plans developed in the QSP and RSP and the Technical Proposal); (d)
estimates of cost/dose delivered in single-use vials; and (e) a plan to monitor and
replenish the stockpile as needed in consultation with managers of the u.s. Government
stockpile (this plan shall be consistent with, and refined from Milestone 8).
	 
	10.	 	Milestone 10-Interim Clinical Trial Report: Within 12 months of contract award or
sooner if it becomes available, provide an Interim Clinical Trial Report that
includes data summary and analysis, interpretation, and conclusions for the dose-response
study. Also included in this report shall be a plan for refinement of follow-on clinical
studies that may have been proposed in the CTP. The U.S. Government and/or the Contractor
may use these data for consultations with the FDA concerning planning for subsequent
product development.
	 
	11.	 	Milestone 11-Interim Animal Studies Report: Within 16 months of contract award, provide
an Interim Animal Studies Report derived from experiments proposed in the ATP.
Included in this report shall be data summaries, analyses, interpretations, and conclusions
of experiments conducted. Also included in this report shall be a plan for follow-on animal
studies that may not have been proposed in the ATP. Lastly, in line with the requirement of
21 CFR 601.91 for GLP to be followed for pivotal studies, an interim
qualification/validation report shall be prepared for selected animal models and their
respective assays.
	 
	12.	 	Milestone 15: Within 36 months of contract award, complete the ATP outlined in
Milestone 4. Each GLP study shall be initiated following Project Officer approval of the
plan and when suitable cGMP vaccine is available.

	 	 	 	 	 
	Statement of Work

	 	ATTACHMENT 1	 	 
	September 30, 2004

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Contract No. HHSN266200400071C

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	13.	 	Milestone 16: Within 36 months of contract award, complete the CTP and RSP outlined
in Milestones 3 and 5, respectively. The U. S. Government and/or the Contractor may use
these data for consultations with the FDA concerning planning for subsequent product
development.
	 
	14.	 	Milestone 17: Within 36 months of contract award, complete the PDP and OSP
outlined in Milestones 1 and 2, respectively.
	 
	15.	 	Milestone 18: Within 36 months of contract award, store, maintain, test and
replenish the vaccine inventory as needed. These activities shall begin after Milestone
7, when the first lot of vaccine is delivered to the DMID.

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

Biweekly Meeting Details: Regular biweekly meetings shall be held between the Principal
Investigator and the Project Officer to monitor progress and address issues and concerns as may
arise. These meetings will be held at NIAID offices or another mutually agreeable location or by
telephone or videoconference at the discretion of the Project Officer. Other government or contract
staff members or consultants may be asked to participate as appropriate. At least two (2) business
days in advance of each biweekly meeting, the Contractor shall provide to the Project Officer a
written (E-mail) outline of the agenda for the upcoming biweekly meeting. Within five (5) business
days following each meeting, the Contractor shall provide to the Project Officer a written (E-mail)
summary of discussions at the last meeting, including documentation of any decisions made at the
meeting.

OPTION PORTION

In accordance with the Statement of Work capabilities in the base portion of the contract,
including the requirements for a Product Development Plan and Quality Systems Plan, and the
successful completion of Milestones 6 and 7 resulting in the manufacture of 500,000 doses, exercise
of the contract option shall require the Contractor to perform the following additional work
requirements:

	1.	 	Milestone 12: Manufacture and release at least two additional consistency lots of
vaccine sufficient for the fill and finish of up to 2.5 million single doses of MVA.
	 
	2.	 	Milestone 13: Complete formulation, fill and finish of all vaccine product that shall
comprise the 2.5 million dose MVA vaccine inventory.
	 
	3.	 	Milestone 14: Deliver and/or store for the U.S. Government, the 2.5 million dose
inventory as directed. Lots may be delivered as they become available if approved by the
Project Officer.

[END OF STATEMENT OF WORK]

	 	 	 	 	 
	Statement of Work

	 	ATTACHMENT 1	 	 
	September 30, 2004

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Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

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-l 034 and SF-1O35, claims may be submitted on the payee’s letter-head
or self-designed form provided that it contains the information shown on the sample
invoice/financing request.

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

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

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

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

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

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

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

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

	(a)	 	Interim Invoice/Contract Financing Request - These are interim payment requests
submitted during the contract performance period.
	 
	(b)	 	Completion Invoice — The completion invoice is submitted promptly upon completion of
the work; but no later than one year from the contract completion date, or within 120 days
after settlement of the final indirect cost rates covering the year in which this contract
is physically complete (whichever date is later).

	 	 	 
	 

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ADB Contract No. NOI-AI-40071

The completion invoice should be submitted when all costs have been assigned to the contract
and all performance provisions have been completed.

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

	 	 	 
	 

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Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	 	 	 	Fringe benefits included in indirect costs should not be identified here.
	 
	 	(3)	 	Accountable Personal Property — Include permanent research equipment and
general purpose equipment having a unit acquisition cost of $1,000 or more and having
an expected service life of more than two years, and sensitive property regardless of
cost (see the DHHS Contractor’s Guide for Control of Government Property). Show
permanent research equipment separate from general purpose equipment. Prepare and
attach Form HHS-565, “Report of Accountable Property,” in accordance with the following
instructions:
	 
	 	 	 	List each item for which reimbursement is requested. A reference shall be made to
the following (as applicable):

	 	-	 	The item number for the specific piece of equipment listed in
the Property Schedule.
	 
	 	-	 	The Contracting Officer’s Authorization letter and number, if
the equipment is not covered by the Property Schedule.
	 
	 	-	 	Be preceded by an asterisk (*) if the equipment is below the
approval level.

	 	(4)	 	Materials and Supplies — Include equipment with unit costs of less than $1,000
or an expected service life of two years or less, and consumable material and supplies
regardless of amount.
	 
	 	(5)	 	Premium Pay — List remuneration in excess of the basic hourly rate.
	 
	 	(6)	 	Consultant Fee  — List fees paid to consultants. Identify consultant by name or
category as set forth in the contract’s Advance Understanding or in the COA letter, as
well as the effort (i.e., number of hours, days, etc.) and rate being billed.
	 
	 	(7)	 	Travel — Include domestic and foreign travel. Foreign travel is travel outside
of Canada, the United States and its territories and possessions. However, for an
organization located outside Canada, the United States and its territories and
possessions, foreign travel means travel outside that country. Foreign travel must be
billed separately from domestic travel.
	 
	 	(8)	 	Subcontract Costs — List subcontractor(s) by name and amount billed.
	 
	 	(9)	 	Other — List all other direct costs in total unless exceeding $1,000 in amount.
If over $1,000, list cost elements and dollar amounts separately. If the contract
contains restrictions on any cost element, that cost element must be listed separately.

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

	 	 	 
	 

	 	ATTACHMENT 2
	 

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Contract No. HHSN266200400071C

ADB Contract No. NOI-AI-40071

	(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. HHSN266200400071C

ADB Contract No. NOI-AI-40071

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,
Le., 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. HHSN266200400071C

ADB Contract No. N01-AI-40071

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 Enthicity and Race

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Sex/Gender	 
	Ethnic Category	 	Females	 	 	Males	 	 	Unknown or Not Reported	 	 	Total	 
	Hispanic or Latino
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Not Hispanic or Latino
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Unknown (Individuals not reporting ethnicity)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Ethnic Category: Total of All Subjects*
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Racial Categories
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	American Indian/Alaska Native
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Asian
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Native Hawaiian or Other Pacific Islander
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Black or African American
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	White
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	More than one race
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Unknown or not reported
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Racial Categories: Total of All Subjects*
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

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

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Racial Categories	 	Females	 	 	Males	 	 	Unknown or Not Reported	 	 	Total	 
	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 Hispanics or Latinos**
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

	*	 	These totals must agree
	 
	**	 	These totals must agree

			
	 	 	 
	Inclusion Enrollment Report

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

 

 

Contract No. HHSN266200400071C

ADB Contract No. N01-AI-40071

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

	(a)	 	Billing Office Name and Address

NATIONAL INSTITUTES OF HEALTH

National Institute of Allergy & Infectious Diseases

Room 3214, 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

	Atm:	 	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	 	 	Contract	 	 	 	 
	Expenditure Category*	 	Negotiated	 	 	Actual	 	 	Current	 	 	Cumulative	 	 	Completion	 	 	Amount	 	 	Variance	 
	A	 	B	 	 	C	 	 	D	 	 	E	 	 	F	 	 	G	 	 	H	 
	(k) Direct Costs:
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(J) Direct Labor
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(2) Fringe Benefits
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(3)Accountable
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Property
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(4) Materials & Supplies
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(5) Premium Pav
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(6) Consultant Fees
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(7) Travel
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(8) Subcontracts
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(9) Other
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total Direct Costs
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(I) Cost of Money
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(m) Overhead
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	G&A
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(n) Fixed Fee
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	(0) 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

			
	 	 	 
	Safety and Health Clause

HHSAR 352.223-70, (1/01)
	 	ATTACHMENT 5

 

 

Contract No. HHSN266200400071C

ADB Contract No. N01-AI-40071

HHSAR 352.223-70 SAFETY AND HEALTH (JANUARY 2001)

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

(End of Clause)

			
	 	 	 
	Safety and Health Clause

HHSAR 352.223-70, (1/01)
	 	ATTACHMENT 5

 

 

Contract No. HHSN266200400071C

ADB Contract No. N01-AI-40071

PROCUREMENT OF
CERTAIN EQUIPMENT

Notwithstanding any other cllause 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.

	 	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) OMB Bulletin 81-16

ATTACHMENT 6

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

OMB Bulletin 81-16
	 	ATTACHMENT 6

 

 

Contract No. HHSN266200400071C

ADB Contract No. N01-AI-40071

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.

			
	 	 	 
	NH(RC)-11

(4/1/84)
	 	ATTACHMENT 7

 

 

ACAMBIS DATA SHARING PLAN

Acambis will share research results when they are final data accepted for publication. However, Acambis does not wish to publish data that might impair its ability to patent any invention. Acambis is aware that the NIH encourages sharing of data generated in
support of its research and development contracts and that the NIH expects that the sharing of research data will lead to products and knowledge of benefit to the public. However, the NIH also recognizes the need to protect patentable and other proprietary data
and that restrictions on sharing data may be imposed by agreements with third parties. In this regard, under the Bayh-Dole Act, Acambis and its subcontractors/grantees have the right to elect and retain title to subject inventions developed with Federal funding
and intend to do so under the MVA program (See Intellectual Property plan at Tab IIG). Premature publication may create a statutory bar to obtaining appropriate patent coverage and compromise the Acambis competitive position with respect to the marketing and
sale of MVA vaccine to the U.S. Government and private market. Since patent protection will be sought for inventions that are patentable, Acambis intends to publicly share the results of final research data only when they are accepted for publication. Acambis
will share data with the NIH prior to publication, but such data will be submitted to the U.S. Government as confidential proprietary information submitted to the Government for evaluation purposes only and subject to protection under 18 U.S.C. 1905 and Section
27 of the Procurement Integrity Act.

The above policy is necessary to avoid the premature publication of sensitive data that describes the attributes or process for our MVA vaccine candidate that we intend to propose for sale to the NIH under the future 50-million dose Request for
Proposal (RFP) expected to be issued to acquire a Government stockpile of MVA vaccine. Such data, in essence, consists of information that will become a portion of the Acambis technical proposal for that future RFP, or is data that may be used to
evaluate the vaccine candidate proposed by Acambis, and, as such, is source-selection sensitive proprietary data to be protected from unauthorized release to competitors and others under Section 27 of the Procurement Integrity Act as implemented by FAR
3.104 et seq. After the contract(s) resulting from the 50-million dose RFP have been awarded, such data might be published or made available to third-parties if such release would not compromise the Acambis/Baxter competitive position for future sale
of MVA.

For any data sharing and publication, Acambis will adhere to the HIPAA Privacy Rule, and the Privacy Act as required by federal statute and regulations.exv4w52

 

Exhibit 4.52

 

Confidential treatment has been requested for certain portions of this exhibit. The copy filed
herewith omits the information subject to the confidential treatment request. Omissions are
designated as “ ***** “. A complete version of this exhibit has been filed separately with the
Commission pursuant to an application for confidential treatment under Rule 24b-2 promulgated under
the Securities Exchange Act of 1934, as amended.

 

SUBCONTRACT

	 	 	 
	Section A — Subcontract Form
	 	 
	 

	 	Subcontract No: MVA-2004-00001BXTR
	Subcontract between:

	 	Purchase Order No: To-Be-Determined
	Acambis Inc.

	 	Prime Contract No: To-Be-Determined
	38 Sidney Street

	 	RFP # NIH-NIAID-DMID-04-49
	Cambridge, MA 02139

	 	Contractual Officer: Roger J. McAvoy
	(“Contractor” or “Acambis”)

	 	Program Officer: Cynthia K. Lee, PhD
	 
	 	 
	               AND
	 	 
	Baxter Healthcare SA

	 	Authorized Representative: Kim C. Bush
	Hertistrassse 2

	 	Project Officer: Andreas Wustinger
	CH-8304 Wallisellen, Switzerland
	 	 
	(“Subcontractor” or “Baxter”)
	 	 

     This Subcontract is entered into this 30th day of September, 2004, between Acambis Inc., 38
Sidney Street, Cambridge, MA 02139 (hereinafter “Contractor”) and Baxter Healthcare SA,
Hertistrassse 2, CH 8304 Wallisellen, Switzerland (hereinafter “Subcontractor). This Subcontract is
issued under the Prime Contract shown in the heading above, as executed between the Contractor and
the United States Government, through the Department of Health and Human Services. In consideration
of the mutual promises, covenants and agreements set forth herein, the parties agree that the
Subcontractor shall furnish and deliver to the Contractor all the supplies and perform all the
services set forth in this Subcontract, for the consideration stated herein. The rights and
obligations of the parties to this Subcontract shall be subject to and governed by this Subcontract
and other documents attached hereto or referenced herein.

     This Subcontract sets forth the entire agreement of the parties and supersedes any and all
prior agreements of the parties, whether oral or written, concerning the subject matter hereof.
Neither party has relied upon any representations, oral or written, in entering into this
Subcontract that are not incorporated herein.

     This Subcontract shall not be varied or changed in its terms or conditions by any oral
agreement or representation, or otherwise, except by an instrument in writing of even or subsequent
date thereto, properly executed.

     The Article and Paragraph titles used herein are for convenience only and shall in no way be
construed as part of this Subcontract, or as an indication of the meaning of a particular section.

     This subcontract shall not be legally binding unless and until approved in writing by the US
Government Contracting Officer.

1

 

IN WITNESS WHEREOF, the parties hereto have executed this Subcontract to be effective as of the day
and year first above written.

	 	 	 	 	 	 	 	 	 
	Acambis Inc.	 	 	 	Baxter Healthcare S.A.
	 
	 	 	 	 	 	 	 	 
	(Contractor)	 	 	 	(Subcontractor)
	By:

	 	/s/ Roger J. McAvoy
	 	 	 	By:
	 	/s/ Kim C. Bush
	 

	 	 
	 	 	 	 	 	 
	 
	Name: Roger J. McAvoy	 	 	 	Name: Kim C. Bush
	Title: Vice President, Government Contracts
	 	 	 	Title: President Vaccines, Baxter
	 	 	   And Legal Affairs	 	 	 	 	 	   BioScience
	 
	 	 	 	 	 	 	 	 
	Execution Date: September 30, 2004	 	 	 	Execution Date: September 30, 2004

2

 

Section A — Introduction

A.1 PURPOSE

The purpose of this subcontract is to continue advanced development and manufacture of an
MVA vaccine to support commercial manufacturing.

A.2 SCOPE OF WORK

Subcontractor, as an independent organization and not as an agent of the Contractor, shall
furnish all labor, materials, supplies, facilities, equipment, transportation and travel
necessary, to ***** other Items set forth in Section B below, according to Section J,
Attachment A.

Section B – Schedule of Subcontract Items/Prices 

B.1 FIRM
- FIXED PRICE ITEMS (EACH ITEM/SUB LINE ITEM IS AN OPTION AND SHALL NOT BE
AWARDED UNLESS AND UNTIL THE CONTRACTOR ISSUES NOTICE OF OPTION EXERCISE — SEE H.25)

	 	 	 	 	 	 	 
	LINE ITEM	 	DESCRIPTION	 	UNIT	 	TOTAL PRICE
	CLIN 0001

	 	Process
Development,
Validation, and
Manufacturing
	 	N/A
	 	N/A
	 
	 	 	 	 	 	 
	CLIN 0001AA

(Milestone 1)

	 	Product Development

Plan (PDP)
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN0001AB

(Milestone 17)

	 	PDP and Quality

Systems Plan (QSP)
Updates
	 	PDP Update

QSP Update
	 	*****

*****
	 
	 	 	 	 	 	 
	CLIN0001AC

(Milestone 2)

	 	QSP
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN0001AD

(Milestone 5)

	 	Regulatory Support

Plan (Manufacturing)
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN0001AE

(Milestone 16)

	 	Updated Regulatory

Support Plan
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0001AF

(Milestone 6)

	 	Summary Report
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0001AG

(Milestone 7)

	 	Process Validation
and Manufacture and
Delivery of MVA
Vaccine Vials
	 	500,000 doses	 	 

3

 

	 	 	 	 	 	 	 
	LINE ITEM	 	DESCRIPTION	 	UNIT	 	TOTAL PRICE
	 

	 	 	 	(a) (Full Testing)	 	(Full Testing)
	 

	 	 	 	*****	 	*****
	 
	 	 	 	 	 	 
	 
	 

	 	 	 	(b) (Full Testing
	 	 
	 

	 	 	 	with *****)
	 	 
	 
	 

	 	 	 	*****	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	 	 	(Full Testing with
	 

	 	 	 	(c) (Limited
	 	*****)
	 

	 	 	 	Testing - *****)
	 	 
	 

	 	 	 	*****
	 	*****
	 
	 	 	 	 	 	 
	 

	 	 	 	(d) Limited Testing
	 	 
	 

	 	 	 	*****)
	 	 
	 

	 	 	 	*****	 	 
	 
	 

	 	 	 	*****	 	 
	 
	 

	 	 	 	 	 	(Limited Testing)
	 

	 	 	 	 	 	*****
	 
	 

	 	 	 	 	 	(Limited Testing
	 

	 	 	 	 	 	*****)
	 

	 	 	 	 	 	*****
	 
	 	 	 	 	 	 
	CLIN 0001AH

(Milestone 1)

	 	Small-Scale Lyo

Study
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0002

	 	Vaccine Stockpile

Maintenance Plan
	 	N/A
	 	N/A
	 
	 	 	 	 	 	 
	CLIN 0002AA

(Milestone 8)

	 	Maintenance,
Testing, and
Replenishment Plan
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003

	 	Large-Scale

Manufacturing
	 	N/A
	 	N/A

4

 

	 	 	 	 	 	 	 
	LINE ITEM	 	DESCRIPTION	 	UNIT	 	TOTAL PRICE
	CLIN 0003AA

(Milestone 9)

	 	Large-Scale

Production Plan
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003AB

	 	Manufacture
	 	2.5 million dose	 	 
	(Milestone 12)

	 	Purified Bulk
	 	equivalent volume	 	 
	 

	 	Vaccine
	 	 	 	 
	 

	 	(Subcontractor may
	 	(a) (Full Testing)
	 	(Full Testing)
	 

	 	prorate billings
	 	*****	 	*****
	 

	 	based upon # equivalent
	 	 	 	 
	 

	 	doses/released lot)	 	(b) Full Testing *****	 	 
	 

	 	 	 	 	 	(Full Testing *****)
	 

	 	 	 	*****	 	*****
	 
	 

	 	 	 	(c) Limited Testing	 	 
	 

	 	 	 	 	 	 Limited Testing
	 

	 	 	 	*****	 	*****
	 
	 

	 	 	 	(d) Limited Testing	 	 
	 

	 	 	 	*****	 	(Limited Testing
	 

	 	 	 	 	 	*****)
	 

	 	 	 	*****	 	 
	 

	 	 	 	 	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003AC

	 	Manufacture	 	 	 	 
	(Milestone 12)

	 	Purified Bulk	 	 	 	 
	 

	 	Vaccine (Same	 	 	 	 
	 

	 	Release Criteria as
	 	***** dose equivalent	 	 
	 

	 	0003AB)
	 	volume
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003AD

	 	Formulate, Fill and
	 	*****	 	 
	(Milestone 13)

	 	Finish Item 0003AB
	 	*****
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003AE

	 	Formulate, fill and
	 	500,000 doses	 	 
	(Milestone 13)

	 	finish Item 0003AC
	 	*****
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003AF

	 	Package/Ship Vials	 	 	 	 
	(Milestone 14)

	 	of Released Vaccine	 	 	 	 
	 

	 	   (Prorate billings	 	 	 	 
	 

	 	based upon # doses	 	 	 	 
	 

	 	shipped in each
	 	*****	 	 
	 

	 	shipment)
	 	(Item ***** Vials)
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0003AG

	 	Package/Ship Vials	 	 	 	 
	(Milestone 14)

	 	of Released	 	 	 	 
	 

	 	Vaccine) (Prorate	 	 	 	 
	 

	 	billings based upon	 	 	 	 
	 

	 	# doses shipped in	 	 	 	 
	 

	 	each shipment)
	 	*****
	 	*****

5

 

	 	 	 	 	 	 	 
	LINE ITEM	 	DESCRIPTION	 	UNIT	 	TOTAL PRICE
	CLIN 0004

	 	Stockpile

Maintenance/Stability 
Studies
	 	N/A
	 	N/A
	 
	 	 	 	 	 	 
	CLIN 0004AA

(Milestone 18)

	 	Stability Program
	 	Lot
	 	*****
	 
	 	 	 	 	 	 
	CLIN 0005

	 	Replenishment

Vaccine
	 	N/A
	 	N/A
	 
	 	 	 	 	 	 
	CLIN 0005AA

	 	Vials MVA Vaccine
	 	Number of Lots -	 	 
	(Milestone 18)

	 	 	 	*****	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	(a) Full Testing
	 	 
	 

	 	 	 	*****
	 	 
	 

	 	 	 	 	 	(Full Testing)
	 

	 	 	 	 	 	*****
	 
	 	 	 	 	 	 
	 

	 	 	 	(b) Full Testing
	 	 
	 

	 	 	 	with *****
	 	 
	 

	 	 	 	 	 	(Full Testing with
	 

	 	 	 	 	 	*****)
	 
	 	 	 	 	 	 
	 

	 	 	 	(c) Limited Testing
	 	 
	 

	 	 	 	*****
	 	 
	 

	 	 	 	 	 	(Limited Testing)
	 

	 	 	 	 	 	*****
	 
	 	 	 	 	 	 
	 

	 	 	 	(d) Limited Testing
	 	 
	 

	 	 	 	*****
	 	 
	 

	 	 	 	 	 	(Limited Testing
	 

	 	 	 	 	 	*****)
	 
	 

	 	 	 	 	 	*****
	 
	 	 	 	 	 	 
	CLIN 0006

	 	Other Direct Cost

(Travel)
	 	Lot
	 	Est. Cost *****

 

	Note: Items 0001AG, 0003AB, 0003AD, 0003AE, 0003AF, and 0003AG may be invoiced for partial
deliveries at the unit price (if a Unit Price is stated above) or at a pro-rata amount of the Total
Price for the lot (if a Unit Price is not stated), based upon the quantity of the Item delivered as
the partial delivery.

Section C — Description/Specification/Work Statement 

C.1

ITEMS 0001- 0005: See Section J, Attachment A for Statement of Work (SOW).

ITEM 0006: See Section G, Provisions G-7 and G-8.

C.2 REPORTING REQUIREMENTS (Applicable to All Items)

The Subcontractor shall submit a Monthly Progress Report providing the information listed below.
The Subcontractor shall submit one copy of the Monthly Progress Report electronically via e-mail.
Monthly progress reports are due on the 7th day of every month. Any attachments to the
e-mail report shall be submitted in MS Windows readable files, such as Microsoft Word, Acrobat
Reader PDF, MS PowerPoint, or MS Excel.

	 	1.	 	A summary of the results of work performed during the reported period.
	 
	 	2.	 	Include pertinent data/graphs in sufficient detail to explain any
significant results achieved and preliminary conclusions.

6

 

	 	3.	 	Describe any problems encountered or expected to occur and described the proposed
corrective action. Differences between planned and actual progress should be
identified and explained, including any cost impacts arising from performance.
	 
	 	4.	 	Listing of all in-process and Quality Control testing completed during
the preceding month, showing start dates and expected end dates, and the results of
such tests for vaccine, diluent, Master Virus Seed and/or Production Virus Seed.

 

	**See Section J, Attachment A, for other data requirements**

Section D — Packaging and Marking

PACKAGING AND MARKING REQUIREMENTS (ITEMS 0001AG, 0003AF, 0003AG, and 0005AA)

	 	(a)	 	Packaging of vaccine for shipment shall conform to Subcontractor’s validated
shipping and packaging protocol to ensure safe delivery by common carrier to
place of destination named by Acambis *****. Each package shall be shipped by airway.
	 
	 	(b)	 	Subcontractor shall mark all shipping containers as “Property of the U.S.
Government” and shall show the Prime Contract, and Subcontract numbers and shall
identify “Acambis Inc.” as the Prime Contractor.
	 
	 	(c)	 	Shipping containers shall be marked and labeled as refrigerated or frozen
materials, as required.

Section E — Inspection and Acceptance 

     The following FAR clauses are incorporated herein by reference. References to the
“Government” shall be deemed to refer to the “Contractor.” References to the “Contractor” shall be
deemed to refer to the “Subcontractors.” To the extent that FAR clauses incorporated herein may
conflict with the clauses set forth below in full text, the clauses in full text shall govern.

	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.246-2

	 	Inspection of Supplies -Fixed-Price (Aug 1996)
	52.246-7

	 	Inspection of Research and Development — Fixed Price (Aug 1996)
	52.246-16

	 	Responsibility for Supplies (Apr 1984)
	52. 246-4

	 	Inspection of Services-Fixed Price (Aug 1996)

E.1 Inspection and Acceptance

	 	(a)	 	Inspection and acceptance of the articles, services, and documentation called
for herein shall be accomplished by the Contractual Officer, or his duly authorized representative (who
for the purposes of this Subcontract shall be the Program Officer). Acambis Quality
Assurance (Q/A) will inspect the deliverable items as set out in Section J, Attachment
A, for conformance with subcontract requirements at Baxter’s premises with the
exception of vaccine samples to be furnished to Acambis for Product Identity Testing
and executed batch records and related documentation, which shall be submitted to
Acambis at its place of business in the United States.
	 
	 	(b)	 	The Contractor may designate one or more representatives to perform on-site
inspection(s) of the physical plant(s) on a full or part time basis. Plant
inspection, at a minimum will include Master Batch Records, document control
procedures, facilities, personnel training records, equipment process procedures, and
Quality Assurance Program reviews.
	 
	 	(c)	 	The Contractual Officer (or his duly authorized representative) shall have
the right to inspect articles, services, and documentation delivered and tendered for
acceptance. Contractor shall make its best effort to inspect and accept delivered
items within thirty (30) work days from the date on which the Subcontractor notifies
the Contractor that the tendered items have been fully performed (including
Subcontractor submission of executed batch records and samples of filled vials for
Product Identity Testing by the Contractor) and are available for inspection, after

7

 

	 	 	 	which time, the tendered items shall be either 1) accepted or 2) rejected. In the
absence of a rejection within forty (40) work days, the fully performed, tendered
item(s) or services shall be deemed accepted. In the case of a rejection, the
Contractor shall in due course provide the Subcontractor with a detailed description
of the nonconformance(s) and, where applicable, evidence such as photographs of the
discrepancies.
	 
	 	(d)	 	Subcontractor agrees to provide and maintain quality control systems
acceptable to Contractor and to provide access to Subcontractors’ facilities at all
reasonable times for surveillance by Contractor and authorized representatives of the
Government .
	 
	 	(e)	 	Contractor shall have the right to audit Subcontractors’ facilities to determine
compliance with (i) cGMP and (ii) applicable federal, state, and local laws,
regulations and rules regarding facilities. Such audits shall be scheduled at
mutually agreeable times upon two (2) business days written notice to Subcontractors
and shall not occur more than one (1) time per calendar year *****. In connection
with performing such audits, each party shall bear its own expenses and the Contractor
shall comply with all reasonable rules and regulations promulgated by Subcontractors.
All information disclosed or reviewed in such inspections shall be deemed to be the
property of the Subcontractor and Subcontractor’s Confidential Information and
Propriety Information.
	 
	 	(f)	 	All notices, forms, approvals, certificates, acceptances and other
communications identified above may be transmitted by facsimile or electronic mail
with e-signature.

E.2 RESEARCH RECORDS, INSPECTION AND CONSULTATION

	 	(a)	 	The Subcontractor agrees to maintain books, records, and supporting
documentation in such detail as will properly reflect all work done and results
achieved in the performance of this contract, and agrees to retain and preserve the
same, together with all research notes, charts, graphs, comments, computations,
analysis, and other graphic or written data (collectively, “documentation”) generated
in connection with performance hereunder and agrees to permit the Contractual Officer
or his authorized representatives to examine and review the same at all reasonable
times during said period. Contractor shall have the right to copy such documentation
at Subcontractor’s facility and to retain such copies for Contractor’s records to the
extent reasonably necessary for regulatory compliance and pharmacovigilence.
Additionally, Subcontractor shall not destroy or dispose of such documents; but shall
furnish the originals and existing copies of such documentation to Acambis, Inc upon
contract completion.
	 
	 	(b)	 	The Contractual Officer or any of his authorized representatives shall have the
right to inspect the work of the Subcontractor and its subcontractors, if any, and the
facilities, floor plans, equipment validation, and any other information, including
laboratories or other premises where the work is being performed. The Subcontractor
shall provide and shall require its subcontractors to provide all reasonable facilities
and assistance for the safety and convenience of such representatives in the
performance of their duties. Personnel engaged in the performance of the contract
shall be available at all reasonable times for consultation with such representatives.
All inspections and review shall be performed in such a manner as will not unduly delay
or interfere with the work.
	 
	 	(c)	 	Additionally, the Subcontractor shall inform the Contractor, in writing, of
any deviations, complaints, and adverse events, as well as the results of all tests
and investigations regarding or possibly impacting the safety or efficacy of the
evaluated product.

E.3 *****

	 	(a)	 	*****
	 
	 	(b)	 	*****

8

 

	 	 	 	(c)

	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.242-15

	 	Stop Work Order (Aug 1989) (the Contractor may exercise its
rights under this clause only if and to the same extent that
the Government has suspended performance under the terms of the
Prime Contract)

F.1 DELIVERABLE (S) SCHEDULE

Periods of Performance: Specified completion dates are based upon the date(s) on which the
Contactor has exercised the option(s) for the various items specified in Section B of the
Subcontract Schedule (Dates After Receipt of Order (ARO). Time required for Contractor inspection
and acceptance under Provision E.2 of delivered items shall not be counted toward the period of
performance by the Subcontractor.

CLIN 0001

     CLIN 0001AA (Milestone 1) - Product Development Plan (PDP)- *****

     CLIN 0001AB (Milestone 17) - Deliver PDP Update and Quality Systems Plan (QSP) Update - *****

     CLIN 0001AC (Milestone 2) -Deliver Quality Systems Plan (QSP)- *****

     CLIN 0001AD (Milestone 5) - Regulatory Support Plan- *****

     CLIN 0001AE (Milestone 16) - Updated Regulatory Support Plan- *****

     CLIN 0001AF (Milestone 6) - Summary Report - *****

     CLIN 0001AG (Milestone 7) - Complete Process Validation and Produce/Deliver ***** doses MVA
vaccine- *****

     CLIN 0001AH (Milestone 1) - Small Scale Lyophilization Study - *****

CLIN 0002

     CLIN 0002AA (Milestone 8) - Develop plan to Maintain, Test, and Replenish MVA vaccine
stockpile- *****

CLIN 0003

     CLIN 0003AA (Milestone 9) - Large Scale Production Plan (50 million doses)- *****

     CLIN 0003AB (Milestone 12) - Manufacture Purified Bulk vaccine 2.5 million doses - *****

     CLIN 0003AC (Milestone 12) - Deliver 500,000 additional dose-equivalent purified bulk vaccine if
500,000 doses from Milestone 7 not produced from conformance lots that successfully
established consistency of manufacture - *****

     CLIN 0003AD (Milestone 13) - Formulate, fill and finish, and label ***** doses MVA            vaccine -
*****

     CLIN 0003AE (Milestone 13) (Option) -Formulate, fill and finish, and label ***** doses- *****

9

 

     CLIN 0003AF (Milestone 14) - Package/Ship ***** dose vials MVA -*****

     CLIN 0003AG (Milestone 14) - Package/Ship additional ***** vials MVA-*****

CLIN 0004

     CLIN
0004AA (Milestone 18) - Stability Study Program – From option exercise until *****

CLIN 0005

     CLIN
0005AA (Milestone 18) - Replenish Government stockpile, as ordered — Ordered vaccine
shall be delivered within a reasonable time ARO, as mutually agreed between the parties.

CLIN 0006 - Perform necessary travel to accomplish SOW from Subcontract Award through Completion

** For Option Exercise Clause, see Special Contract Provision H.25.

Section G — Subcontract Administration Data 

G.1 INVOICE/VOUCHER SUBMISSION

Invoices (Fixed-Price)

	 	(1)	 	Subcontractor shall submit an original and three (3) copies
of Subcontract invoices to:

Acambis Inc.

Accounts Payable

38 Sidney Street

Cambridge, MA 02139

	 	(2)	 	Subcontractor agrees to include (at a minimum) the
following information on each invoice:

	 	i.	 	Subcontractor’s Name & Address;
	 
	 	ii.	 	Subcontractor’s Tax Identification Number (TIN);
	 
	 	iii.	 	Prime Contract, Subcontract, and Purchase Order Numbers (and
	 
	 	iv.	 	Invoice Number;
	 
	 	v.	 	Invoice Date;
	 
	 	vi.	 	Subcontract ITEM Number (See Section B);
	 
	 	vii.	 	Quantity;
	 
	 	viii.	 	Unit Price;
	 
	 	ix.	 	Total Amount of Invoice;
	 
	 	x.	 	Name, title and telephone number of person
to be notified in the event of a defective invoice;
	 
	 	xi.	 	Payment Address, if different from the
information in (2) i. above;
	 
	 	xii.	 	Electronic Funds Transfer Information (EFT)
	 
	 	xiii.	 	For Other Direct Costs (Item 0005), an
itemized listing of expenses for which reimbursement is sought,
supported by receipts for each item of expense exceeding
$75.00.

	 	(3)	 	Any invoice not containing the above
information/documentation may be considered defective and returned to the
Subcontractor without payment within five (5) business days.

10

 

G.2 CONTRACTOR’S OBLIGATION TO PAY

Subcontractor may submit an invoice for payment upon Subcontractor shipment of any end
item(s) accepted by the Contractor. Contractor agrees to make payment by wire within
thirty (30) days following receipt of a properly submitted invoice from the Subcontractor.
Payment shall be deemed to have been “made” on the date that the electronic transfer of
funds has been authorized. Late payments (other than as to amounts for which Contractor
liability to Subcontractors is in dispute under Paragraph H. 19 DISPUTES or Paragraph H. 21
CLAIMS INVOLVING THE GOVERNMENT) shall accrue simple interest (at the then prime rate as
published by the Federal Reserve Board) from thirty (30) days after receipt of a proper
invoice from the Subcontractor until the date of payment.

G.3 PROGRAM/PROJECT OFFICER(S)

I. For the Contractor:

	 	(a)	 	Performance of the work hereunder shall be subject to the technical
directions of the designated Program Officer for this Subcontract.
	 
	 	(b)	 	The Program Officer is not authorized to change any of the terms or
conditions of the Subcontract. In the event that the Subcontractor believes that
implementation of any of the direction issued by the Program Officer constitute a
change to the Subcontract requirements or to otherwise warrant an adjustment to
Subcontract price, Subcontractor shall promptly notify the Program Officer and the
Contractual Officer in writing.
	 
	 	(c)	 	Contractor may from time to time change the person designated as the Program
Officer for this Subcontract by delivering a written notice of such change to
Subcontractors.
	 
	 	(d)	 	The designated Program Officer for this project is:
	 
	 	 	 	Cynthia K. Lee, PhD

Principal Investigator

*****

*****

*****

*****

*****

II. For the Subcontractor:

	 	(a)	 	Correspondence for technical performance of the work hereunder shall be
addressed to the Subcontractor’s designated Project Officer.
	 
	 	(b)	 	The Project Officer is not authorized to change any of the terms or
conditions of the Subcontract.
	 
	 	(c)	 	The designated Project Officer for this project is:

Andreas Wustinger

Senior Project Manager

*****

*****

*****

*****

*****

11

 

G.4 CONTRACTUAL OFFICER

	 	(a)	 	The Contractual Officer is the only individual who can legally commit the
contractor to the expenditure of funds. No other person other than the Contractual
Officer can make any changes to the terms, conditions, general provisions, or other
stipulations of this subcontract. Such changes may only be made by mutual agreement
of the parties through their duly authorized representatives, in writing. If any such
change causes an increase or decrease in the cost of, or the time required for work
under this Subcontract, whether or not changed, the Subcontract price and delivery
schedule shall be subject to equitable adjustment.
	 
	 	(b)	 	No information, other than that which may be contained in an authorized
modification to this Subcontract, duly issued by the Contractual Officer, which may be
received from any person employed by the Contractor, or otherwise, shall be considered
grounds for deviation from any stipulation of this Subcontract.
	 
	 	(c)	 	Contractor may from time to time change the person designated as the
Contractual Officer for this Subcontract by delivering a written notice of such change
to Subcontractor. Except for changes mutually agreed to by the parties under
subparagraph (a) above, the Subcontractor must assert its right to an equitable
adjustment for any changes under this clause within 30 days from actual or
constructive notice or knowledge of the event that gave rise to the equitable
adjustment sought. However, if the Contractual Officer decides that the facts justify
it, the Contracting Officer may receive and act upon a proposal for equitable
adjustment submitted before final payment.
	 
	 	(d)	 	The designated Contractual Officer for this Subcontract is:

Roger J. McAvoy

Vice President, *****

*****

*****

*****

*****

*****

*****

	 	(e)	 	Contractor designates the following individual and agrees to make such
individual available to Subcontractor for receipt of subcontract administration
matters:

NAME: Mark S. Stay

ADDRESS: *****

                    *****

                    *****

TELEPHONE: *****

FAX: *****

E-MAIL: *****

G. 5 AUTHORIZED REPRESENTATIVE OF SUBCONTRACTOR

	 	(a)	 	The Authorized Representative of Subcontractor is the only individual who can
legally commit the Subcontractor. No person other than the Authorized Representative
of Subcontractor can agree to any changes to the terms, conditions, general
provisions, or other stipulations of this Subcontract.
	 
	 	(b)	 	No information, which may be received from any person employed by
Subcontractor other than from the Subcontractor’s Authorized Representative, shall be
considered grounds for deviation from any stipulation of this Subcontract.
	 
	 	(c)	 	Subcontractor may from time to time change the person designated as the
Authorized Representative for this Subcontract by delivering a written notice of such
change to Contractor.
	 
	 	(d)	 	The Authorized Representative of the Subcontractor for this Subcontract is:

12

 

Kim C. Bush

President Vaccines, *****

*****

*****

*****

*****

*****

G.6 SUBCONTRACT COMMUNICATIONS/CORRESPONDENCE

Subcontractor shall identify all correspondence, reports, and other data pertinent to this
Subcontract by imprinting thereon the Subcontract number from Page 1 of the Subcontract.

G.7 REIMBURSEMENT OF OTHER DIRECT COSTS (CLIN 0006 only)

(a) Contractor shall reimburse the Subcontractor its allowable costs incurred and properly
allocable to this contract, in accordance with the clause entitled Allowable Cost and
Payment (See Section I). Costs that may be allowable include the following:

	 	(1)	 	Travel costs plus per diem or actual subsistence for
personnel while in an actual travel status in direct performance of the work
and services required under this contract. These costs will be in accordance
with the Subcontractor’s policy and subject to the following:

	 	(i)	 	Air travel shall be by the most direct
route using “air coach” or “air tourist” (less than first class)
unless use of air coach or air tourist is clearly unreasonable or
impractical (e.g., not available for reasons other than avoidable
delay in making reservations, would require circuitous routing or
entail additional expense offsetting the savings on fare, or would
not make necessary connections).
	 
	 	(ii)	 	Rail travel shall be by the most direct
route, first class with lower berth or nearest equivalent.
	 
	 	(iii)	 	Costs incurred for lodging, meals, and
incidental expenses shall be considered reasonable and allowable to
the extent that they do not exceed on a daily basis the per diem
rates set forth in the Federal Travel Regulation (FTR).
	 
	 	(iv)	 	Travel via privately owned automobile shall
be reimbursed at not more than the current General Services
Administration (GSA) FTR established mileage rate.
	 
	 	(v)	 	All allowable travel costs under this
paragraph will be invoiced and reimbursed in US dollars. Conversion
to US dollars from foreign currency will be as of the date the cost
was incurred. Receipts in excess of $75.00 must be provided with the
invoice.

G.8 LIMITATION OF COST (CLIN 0006 only)

	 	(a)	 	It is estimated that the cost to the Contractor for the performance of CLIN
0006 of this Contract will not exceed the estimated cost set forth in the Subcontract
Schedule. Subcontractor agrees to use reasonable efforts to perform the work specified
in the Schedule within such estimated cost.
	 
	 	(b)	 	If at any time the Subcontractor has reason to believe that the costs that it
expects to incur subject to reimbursement under Item 0006 within the next succeeding
thirty (30) days,

13

 

	 	(c)	 	when added to all Other Direct Costs previously incurred and subject to
reimbursement under Item 0006, will exceed seventy-five percent (75%) of the total
estimated cost for Item 0006 as shown in the Subcontract Schedule, the
Subcontractor shall notify the Contractual Officer in writing to that effect. The
notice shall state the estimated amount of additional funds required to continue
performance for the duration of the Subcontract period of performance for “Other
Direct Costs” required.
	 
	 	(d)	 	Except as required by other provisions of this contract specifically citing
and stating that they are an exception to this provision, the Contractor shall not be
obligated to reimburse the Subcontractor for Other Direct Costs incurred in excess of
the Estimated Cost for Item 0006 as set forth in the Subcontract Schedule and the
Subcontractor shall not be obligated to incur Other Direct Costs in excess of the
Estimated Cost for Item 0006, unless, and until, the Contractual Officer has
notified the Subcontractor in writing that the Estimated Cost for Item 0006 has been
increased and the amount of such increase. No notice, communication, or
representation in any other form, or from any person other than the Contractual
Officer, shall be deemed to be an increase to the Estimated Cost of Item 0006. When
and if the Estimated Cost for Item 0006 in the Subcontract Schedule is increased by
the Contractual Officer, the Subcontractor shall be entitled to reimbursement of any
Other Direct Costs incurred, whether incurred before or after the date on which the
Contractual Officer notified the Subcontractor that the Estimated Cost of Item 0006
has been increased, to the extent that such costs are allowable Other Direct Costs
properly allocable to this subcontract. If the Contractual Officer issues a
termination or other notice, the Contractual Officer may increase the Estimated Cost
for Item 0006 and direct that the increase be used solely for the purpose of Other
Direct Costs associated with termination activities.
	 
	 	(e)	 	Change orders issued pursuant to the Changes clause shall not be considered
an authorization to the Subcontractor to exceed the Estimated Cost for Item 0006 in
the absence of a statement in the change order, or other contractual modification,
increasing the Estimated Cost of Item 0006 set forth in the Subcontract Schedule.

G.9 Performance-Based Payments

     The Contractor shall make payment for completed item(s) when such items have been delivered
and accepted, as specified by Subcontract Provision G.2 and B1. The following item(s), however,
involve substantial efforts/costs to be incurred by the Subcontractor before the item is completed
and delivered under the terms of the Subcontract. For the Item(s) specified below,
performance-based payments shall be made to the Subcontractor in accordance with the Performance -
Based Payments clause of this Subcontract. Such performance-based payments may be invoiced upon
successful completion of the specified milestone.

	 	 	 	 	 	 	 	 	 
	LINE ITEM	 	DESCRIPTION	 	TOTAL PRICE	 	MILESTONE EVENT	 	MILESTONE PAYMENT
	0004AA

	 	Stability Program
	 	*****
	 	*****
	 	*****
	 

	 	 	 	 	 	Subcontract Award	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	*****
	 	*****
	 

	 	 	 	 	 	Subcontract Award	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Completion of 0004AA
	 	Balance of Item
	 

	 	 	 	 	 	 	 	Price

Section H — Special Subcontract Requirements

H.1 KEY PERSONNEL

The key personnel cited below are considered essential to the work being performed under
the Subcontract. If these individuals leave the Subcontractor’s employ or are reassigned to
other programs, Subcontractor shall notify the Contractual Officer reasonably in advance
and shall submit justification (including proposed substitutions) in sufficient detail to
permit evaluation of the impact on the program. The Subcontractor shall not divert or
replace such individuals without the written consent of the Contractual Officer, which
shall not be unreasonably withheld.

14

 

	 	 	 	 	 
	Personnel	 	Title	 	Organization
	Andreas Wustinger

	 	Senior Project Manager, Vaccines
	 	Baxter Bioscience
	Noel Barrett, Ph.D.

	 	Sr.Vice-President	 	Baxter BioScience
	 	 	Global R&D Vaccines	 	 

H.2 PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES

Subcontractor is hereby notified of the restrictions on the use of DHHS’s funding for
lobbying of federal, state and local legislative bodies.

Section 1352 of Title 31, United Stated Code among other things, prohibits a recipient (and
their subcontractors) of a federal contract, grant, loan, or cooperative agreement from
using appropriated funds (other than profits from a federal contract) to pay any person for
influencing or attempting to influence an officer or employee of any agency, a Member of
Congress, an officer or employee of Congress, or an employee of a Member of Congress in
connection with any of the following covered federal actions; the awarding of any federal
contract; the making of any federal grant; the making of any federal loan; the entering
into of any cooperative agreement; or the modification of any federal contract, grant,
loan, or cooperative agreement. For additional information of prohibitions against
lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, the current DHHS Appropriations Act provides that no part of any appropriation
contained in this Act shall 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 or local legislature except in presentation to the Congress, or
any state or local legislative body itself.

The current DHHS Appropriations Act also provides that no part of any appropriation
contained in this Act shall be used to pay the salary or expenses of any contract or grant
recipient, or agent acting for such recipient, related to any activity designed to
influence legislation or appropriations pending before the Congress, or any state or local
legislature.

H.3 INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS

Subcontractor shall:

(a) Maintain an appropriate written, enforced policy on conflict of interest that complies
with 42 CFR Part 50 Subpart F and/or 45 CFR Part 94 as appropriate and inform each
investigator of the Subcontractor’s (Institution’s) policy, the Investigator’s reporting
responsibilities, and the applicable regulations. If the Institution carries out the NIH
funded research through subgrantees, subcontractors or collaborators, the Institution must
take reasonable steps to ensure that Investigators working for such entities comply with
the regulations, either by requiring those investigators to comply with the Institution’s
policy or by requiring the entities to provide assurances to the Institution that will
enable the Institution to comply with the regulations.

(b) Designate an Institutional official(s) to solicit and review financial disclosure
statements from each Investigator who is planning to participate in NIH-funded research.

(c) Require that by the time an application/proposal is submitted to the NIH, each
investigator who is planning to participate in the NIH-funded research has
submitted to the designated official(s) a listing of his/her known Significant
Financial Interests (and those of his/her spouse and dependent children): (i) that
would reasonably appear to be affected by the research for which the NIH
funding is sought; and (ii) in entities whose financial interests would reasonably appear
to be affected by the research. All financial disclosures must be updated during the period
of the award, either on an annual basis or as new reportable Significant Financial
Interests are obtained.

15

 

(d) Provide guidelines consistent with the regulations for the designated official(s) to
identify conflicting interests and take such actions as necessary to ensure that such
conflicting interests will be managed, reduced, or eliminated.

(e) Maintain records, identifiable to each award, of all financial disclosures and all
actions taken by the institution with respect to each conflicting interest for: (1) in the
case of grants, at least three years from the date of submission of the final expenditures
report or, where applicable, from other dates specified in 45 CFR Part 74.53(b) and (2) in
the case of contracts, 3 years after final payment or, where applicable, for the other time
period specified in 48 CFR Part 4 Subpart 4.7, Contract Records Retention.

(f) Establish adequate enforcement mechanisms and provide for sanctions where appropriate.

(g) Certify, in each application/proposal for funding to which the regulations applies,
that:

      1) there is in effect at the Institution a written and enforced administrative process
to identify and manage, reduce or eliminate conflicting interests with respect to all
research projects for which funding is sought from the NIH;

      2) prior to the Institution’s expenditure of any funds under the award, the
Institution will report to the Contractor (awarding component) the existence of a
conflicting interest (but not the nature of the interest or other details) found by the
Institution and assure that the interest has been managed, reduced or eliminated in accord
with the regulations; and for any interest that the Institution identifies as conflicting
subsequent to the expenditure of funds after award, the report will be made and the
conflicting interest managed, reduced, or eliminated, at least on a temporary basis within
sixty days of that identification;

      3) the Institution agrees to make information available, upon request, to the
awarding component regarding all conflicting interests identified by the Institution and
how those interested have been managed, reduced, or eliminated to protect the research from
bias; and 4) the Institution will otherwise comply with the regulations.

H.4 INSTITUTIONAL MANAGEMENT OF CONFLICTING INTERESTS

(a) The designated official(s) must: (1) review all financial disclosures; and (2)
determine whether conflict of interest exists, and if so, determine what actions should be
taken by the Institution to manage, reduce or eliminate such conflict of interest. A
conflict of interest exists when the designated official(s) reasonably determines that a
Significant Financial Interest could directly and significantly affect the design, conduct,
or reporting of the NIH-funded research.

(b) Examples of conditions or restrictions that might be imposed to manage actual or
potential conflicts of interests include, but are not limited to:

(i) public
disclosure of significant financial interests;

(ii) monitoring of research by independent reviewers;

(iii) modification of the research plan;

(iv) disqualification of the Investigator(s) from participation
in all or a portion of the research funded by the    awarding component;

(v) divestiture of significant financial interests; or,

(vi) severance of relationships that create actual or potential
conflicts of interests.

(c) An Institution may require the management of other conflicting financial interests in
addition to those described in paragraph (a) of this section, as the Institution deems
appropriate.

H.5 REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

The Representations, Certifications and Other Statements of Offerors submitted by
Subcontractor, Section J, Attachment B, are hereby incorporated by reference, with the same
force and effect as if they were given in full text.

16

 

H.6 LABORATORY LICENSE REQUIREMENTS

The Subcontractor shall comply with all applicable FDA requirements and the requirements of
Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as
amended) to the extent applicable to subcontract performance. This requirement shall also
be included in any lower-tier subcontract awarded by the Subcontractor

H.7 MANUFACTURING STANDARDS

	 	(a)	 	The current Good Manufacturing Practices (cGMP) regulations (21 CFR Parts
210-211) will be the standard to be applied for manufacturing under this Subcontract.
	 
	 	(b)	 	If at any time during the life of the Subcontract, Subcontractor fails to
comply with cGMP in the manufacturing of the vaccine and such failure results in a
material adverse effect on the safety, purity or potency of this vaccine (a material
failure) as identified by the Center for Biologics Evaluation and Research of the FDA,
the Subcontractor shall have thirty (30) calendar days from the time such material
failure is identified within which to cure such material failure. If the
Subcontractor fails to take such action within the thirty (30) calendar day period,
the Subcontract may be terminated.

H.8 DISSEMINATION OF INFORMATION

Information related to this Subcontract or to data obtained or generated under this
Subcontract may be released or publicized only after coordination with the Contractual
Officer, provided, however, that the Subcontractor may, notwithstanding anything in this
clause, disclose such information to third parties, under appropriate confidentiality
restrictions, as may be necessary or useful in connection with the manufacturing or storage
of MVA vaccine hereunder.

H.9 CONFIDENTIALITY OF PROPRIETARY INFORMATION AND INTELLECTUAL PROPERTY RIGHTS

*****

17

 

H. 10 MANUFACTURING SITE

The manufacturing site for vaccine under this Subcontract shall be at the address shown
below. Alternate sites may be used upon receipt of written approval from the Contractual
Officer.

*****

H. 11 GOVERNMENT PROPERTY/CONTRACTOR FURNISHED PROPERTY

Subcontractor shall be responsible for the control and accountable record keeping for all
Government Property in its possession under this subcontract in accordance with FAR Subpart
45.5. Similar controls and record keeping procedures shall be used for any
Contractor-furnished property as well.

The Subcontract Program Officer (or her duly authorized representative) shall be the
Contractor’s Property Administrator for any Government or Contractor-furnished property
under this Subcontract. The Subcontractor agrees to furnish information regarding any
Government property (or any Contractor-furnished property) under this Subcontract to the
respective Property Administrator, an authorized representative, or a duly designated
successor(s). Any inquiry from or information proposed to be furnished to the Government
Property Administrator shall be promptly reported to Contractor’s Property Administrator
before furnishing information to the Government representative.

The following Government property shall be furnished to the Subcontractor “as is” under
this Subcontract. Such items shall be marked as U.S. Government Property, with Subcontract
No. MVA-2004-00001(BXTR), the Prime Contract No. (TBD), (Acambis Inc, Prime Contractor) (if
not already so marked when received) and shall be managed and administered while in
Subcontractor’s possession in accordance with the Government Property (Fixed Price
Contracts) (Dec 1989) clause, FAR 52.245-2:

*****

*****

The following Acambis property shall be furnished to the Subcontractor “as is” for use in
performance of the Subcontract:

*****

*****

Any residual Acambis-furnished property (and related documentation provided by Acambis)
shall be returned to the Contractor upon subcontract completion, at Contractor expense.

18

 

H.12 LIMITATION OF LIABILITY

*****

H.13 ASSIGNMENT OF CLAIMS

Assignment of this Subcontract, or any interest therein, or any payment due or to become
due thereunder, without the prior written consent of Contractor, which shall not be
unreasonably withheld, shall be void. Should Contractor approve any assignment thereof, in
no event shall any copy of any part or all of this Subcontract which is marked “Top
Secret”, “Secret,” “Confidential”, or “Proprietary Information” be furnished to any
assignee of any claim arising under this Subcontract, or to any person not entitled to
receive the same, without prior written consent of Contractor.

H.14 VALIDITY OF INDIVIDUAL PROVISION

The invalidity, in whole or in part, of any provision of this Subcontract shall not void or
otherwise affect the validity of any other provision.

H. 15 WAIVER OF BREACH

No waiver of a breach of any provision of this Subcontract shall constitute a waiver of any
other breach of such provision, nor shall waiver of breach of any provision of this
contract constitute a waiver of breach of any other provision of this contract. Failure of
any party to enforce at any time, or from time to time, any provision of this Subcontract
shall not be construed as a waiver thereof. The remedies herein shall be cumulative and
additional to any other remedies in law and in equity.

H. 16 COMPLIANCE WITH LAWS

Each party agrees to comply with all applicable U.S. federal, state and municipal laws and
ordinances and all rules and regulations thereunder. *****

H.17 INDEPENDENT CONTRACTOR

It is understood and agreed that Subcontractor is an independent contractor in all its
operations and activities hereunder; that the employees furnished by Subcontractor to
perform work hereunder shall be deemed to be Subcontractor’s employees exclusively, without
any relationship to Contractor with respect to their employment; that said employees shall
be paid by Subcontractor for all services in this connection, and that Subcontractor shall
be responsible for all obligations and reports covering Social Security, unemployment
insurance, workers’ compensation, income tax, and other reports and deductions required by
state, U.S. federal, or foreign law.

H.18 SOLICITATION OF EMPLOYEES

Each of the parties agrees that, during the term of this Subcontract and for a period of
one (1) year thereafter, it will not directly solicit or recruit the employees of the other
party associated with the performance of this Subcontract. Nothing herein shall preclude
any employee of any party from pursuing and securing employment opportunities with another
party on such employee’s own initiation.

19

 

H.19 DISPUTES

Any dispute arising under or related to the performance of this Subcontract, including the
breach, termination, or validity thereof, that is not resolved by good faith negotiations
shall, upon the written request of either party, be submitted to non-binding arbitration to
be conducted in accordance with the rules of the CPR Institute for Dispute Resolution for
Non-Administered Arbitration by a sole arbitrator who is a member of the National Health
Lawyers Association or another mutually agreeable individual. Such arbitrator shall set a
schedule for determination of such dispute that is reasonable under the circumstances.
Such arbitrator shall determine the dispute in accordance with the substantive rules of law
(but not the rules of procedure) as required by Paragraph H.21 below. The arbitration
shall take place in Delaware. The arbitration will be governed by the Federal Arbitration
Act, 9 U.S.C. §§ 1-16, and, where applicable, the Patent Arbitration Act, 35 U.S.C. § 294.
Each party shall bear its own costs of such arbitration and shall equally share the common
costs of the arbitration.

In the event that non-binding arbitration fails to resolve a dispute, any legal proceedings
between the Contractor and the Subcontractor shall be brought and jurisdiction and venue
shall be proper only in the United States District Court for the District of Delaware, or
if jurisdiction is lacking, the Courts of the State of Delaware.

Pending final resolution of any dispute, as evidenced by a written agreement of the
parties, or in the event of legal proceedings, as evidenced by final judgment by a court of
competent jurisdiction, the parties shall proceed diligently with the performance of their
respective responsibilities under this Subcontract, except to the extent that Contractor
may have terminated the Subcontract.

Any reference to disputes procedures in FAR clauses incorporated into this Subcontract
by reference shall be deemed to refer to this provision.

H.20 GOVERNING LAW

The validity, construction, scope and performance of this Subcontract, including any
attachments and modifications hereto, and all disputes related thereto, shall be governed
by the laws of the State of Delaware, without regard to its “Choice of Law” provisions;
except that with respect to any provisions “flowed-down” from the Prime Contract or based
upon FAR clauses, such provisions shall be interpreted and governed by the body of federal
government procurement law interpreting such provisions.

H.21 CLAIMS INVOLVING THE GOVERNMENT

	(a)	 	Government Claims Against Contractor and Contractor Claims Against the Government - To the
extent that the Contractor may present any request for equitable adjustment, request for
schedule extension, settlement proposal, or other matter to the Government that may become a
“claim” under the Contract Disputes Act of 1978 (41 U.S.C. 604)(hereinafter referred to as the
Contract Disputes Act); or, to the extent that the Government may assert any claim against the
Contractor, the Parties agree:

	 	(1)	 	To the extent that such matters involve the performance of this
Subcontract, Subcontractors shall fully cooperate with the Contractor, provide
supporting documentation, witnesses, statements, and otherwise participate in
negotiations with or litigation against the Government, to the extent reasonably
requested by the Contractor.
	 
	 	(2)	 	That the Subcontractor shall not be bound by any settlement the
Contractor may make with the Government or other compromise with respect to any
matter within the coverage of paragraph (a)(1) above unless the Subcontractor
agrees to such settlement or compromise in writing.
	 
	 	(3)	 	That, if the Government issues a final decision of the Contracting
Officer under the terms of the Prime Contract with respect to any claim described
in paragraph (a) above, and the Contractor elects not to file an appeal from such
final decision under the Disputes provisions of the Prime Contract, within sixty
(60) days of Contractor receipt of such final decision; the Contractor may
authorize the Subcontractor to appeal such final decision, in the name of and with
the consent of the Contractor, at the Subcontractor’s expense. In the event that
the Subcontractor elects to appeal any such final decision, the Contractor

20

 

	 	(4)	 	shall cooperate with the Subcontractor in the same manner provided in subparagraph
(1) above with respect to Subcontractor cooperation with the Contractor.

	(b)	 	Subcontractor Claims Against the Government - To the extent that the costs of Subcontract
performance have been increased or the schedule or manner of Subcontract performance has been
adversely affected by actions or inactions of the Government, and the Subcontractor request
consent to pursue a claim against the Government, the Parties agree as follows:

	 	 	 	If the subject matter of the Subcontractor claim is not within the coverage of a
matter governed by paragraph (a) above, Subcontractor shall submit to the
Contractor a fully supported claim with respect to such matter no later than final
payment under this Subcontract.
	 
	 	 	 	If the Parties are unable to resolve the Subcontractor’ claim within ninety
(90) days of Subcontractor’s submission to the Contractor, the Contractor may
either: (A) Present a request for equitable adjustment or other relief, as
appropriate, to the Government, which submission shall embody the Subcontractor’s
claim and shall be governed by paragraph (a) above, or (B) may authorize the
Subcontractor to assert such claim against the Government on behalf of the
Contractor, to negotiate a settlement thereof, and to prosecute any appeal from
any final decision of the Government Contracting Officer with respect to such
claim, in the name of and with the consent of the Contractor.

	(c)	 	If the Contractor authorizes the Subcontractor to assert any claim against the Government
in the name of the Contractor, or to prosecute an appeal from the final decision of the
Government Contracting Officer, in the name of and with the consent of the Contractor, if the
claim is subject to certification by the Contractor under the Contract Disputes Act,
Subcontractor shall submit with their claim, when submitted to the Contractor under paragraph
(b)(1), a certification that: (i) the claim is made in good faith, (ii) the supporting data
are accurate and complete to the best of the Subcontractors’ knowledge and belief, and (iii)
the amount requested accurately reflects the Subcontract adjustment for which Subcontractors
believe the Government through the Contractor is liable; furthermore, such certification shall
be executed by a person duly authorized to certify the claim and bind Subcontractor, and
Subcontractor shall indemnify and hold Contractor harmless from damages, judgments, costs
(including reasonable attorneys’ fees), and other liabilities arising from any breach of such
certification or any violation of section 5 of the Contract Disputes Act of 1978 (41 U.S.C. §
604) or any violation of common law or statutory prohibitions against misrepresentations, fraud
or false statements.
	 
	(d)	 	Contractor shall include interest in the amount of any Subcontract price adjustment to which
the Subcontractors are found entitled on any Subcontractor claim. Such interest shall be
computed from (1) the date the Contractor received the Subcontractor’s claim (certified, if
required) or (2) from the date that such Subcontract payments would otherwise be due, if such
date is later, until the date of payment to the Subcontractor. If the Subcontractor’s
certification was defective, but is cured prior to the date of settlement or the date on which
the Board of Contract Appeals or Court enters judgment, such defect shall not affect the
computation of interest to which the Subcontractor is entitled. Simple interest shall be paid
at the rate fixed by the Secretary of the Treasury under the Contract Disputes Act, from the
date such interest is first payable until payment to the Subcontractor, as such rate may be
adjusted by the Secretary of the Treasury each six months during the pendency of the claim.
	 
	(e)	 	The Contractor and Subcontractor shall each bear their own costs of prosecuting any claims
under this provision.
	 
	(f)	 	With respect to any claim under this provision affecting both the Contractor and the
Subcontractor, the parties agree to enter into a formal or informal joint defense agreement,
the parameters of which shall be mutually agreed upon by the parties, and further to (i)
promptly cooperate in the case, (ii) grant reasonable requests to make records and employees
available to the other party, (iii) provide to the other party free of charge, copies of all
pleadings, filings, and communications with the Government, and (iv) inform the other party of
all oral communications with the Government.
	 
	(g)	 	Nothing in this Subcontract shall be construed to grant the Subcontractor the right to file
any claim under this Subcontract directly against the Government or to appeal, other than in
the name of and with the consent of the Contractor, any final decision of the Government
Contracting Officer under the Disputes clause of the Prime Contract.

H.22 PRODUCT CHANGES, COMPLAINTS, AND ADVERSE EVENTS

	(a)	 	Subcontractor agrees to inform Contractor within fifteen (15) calendar days of the result
of any regulatory development or change to vaccine-specific standard operating procedures that
materially

21

 

	 	 	affect the production of the vaccine. Subcontractor shall notify Contractor of and require
written approval from Contractor for change to master batch records and vaccine specifications
prior to the production of the vaccine.
	 
	(b)	 	***** Subcontractor agrees to inform Contractor of any manufacturing deviations that might
be reportable under 21 CFR 600.14 within ten (10) calendar days of obtaining such information.
	 
	(c)	 	***** Subcontractor and Contractor shall report to the other any information that they have
knowledge of concerning any adverse drug experience in connection with the use of the vaccine,
including the incidence or severity thereof, associated with non-clinical toxicity studies,
clinical uses, studies, investigations or tests, whether or not determined to be attributable
to the vaccine. Reports of routine adverse drug experiences of the type defined in Section
214.80 of Title 21 of the United States Code of Federal Regulations shall be exchanged by each
party on a quarterly basis. Reports of serious adverse drug experiences of the type defined in
Sections 312.32 and 314.80 of Title 21 of the United States Code of Federal Regulations shall
be made available to the other party within five (5) calendar days after a party becomes aware
of such adverse drug experience. Upon receipt of any such information concerning any serious
drug experience by either the Subcontractor or the Contractor, the parties shall promptly
consult each other and use their best efforts to arrive at a mutually acceptable procedure for
taking such possible actions as appropriate or required under the circumstances. The
Contractor shall promptly provide a copy of any report filed with and communications received
from the US FDA related to product complaints or (serious) adverse drug experiences.
	 
	(d)	 	The parties will inform each other within forty-eight (48) hours of notice of any inspection
by the competent authorities related to the vaccine or the production, testing, or packaging
of the same. A copy of all observations and all warning letters concerning the production,
storage, and distribution of the vaccine and any related correspondence, will be promptly
provided by the affected party to the other party. The non-affected party will assist in
responding to observations or warning letters, but the final responsibility for responding to
such matters will be that of the party to whom the FDA or other competent authority directed
the inquiry or act.

H.23 PRODUCT RECALL AND FIELD CORRECTIVE ACTIONS

In the event Contractor shall be required to recall any vaccine furnished under this
subcontract because such vaccine may violate local, state or federal laws or regulations or the
product specifications, or in the event that Contractor elects to institute a voluntary recall,
Contractor shall be responsible for coordinating such recall and shall, except as provided
below, bear all related cost and expenses. Contractor shall promptly notify Subcontractor if
any vaccine is the subject of a recall and provide Subcontractor with a copy of all documents
relating to such recall.

Subcontractor shall cooperate with Contractor in connection with any recall at Contractor’s
expense, except in the event that a recall (which term includes any product withdrawal or field
correction) is necessary because either (i) the Subcontractor has delivered a non-conforming
product to Contractor, or (ii) such recall was due to the negligence of Subcontractor,
Subcontractor shall bear all reasonable costs associated with such recall (including, but not
limited to, costs associated with receiving and administering the recalled vaccine and
notification of the recall to those persons whom Contractor deems appropriate).

H.24 TRUTH-IN-NEGOTIATIONS/PROCUREMENT INTEGRITY

Subcontractor shall indemnify and hold the Contractor harmless from
any liability that the Contractor may have to the U.S. Government
based upon any cost or pricing data (as defined in FAR Subpart 15.4)
that the Subcontractor submitted to the Contractor or to the U.S.
Government, or that Subcontractor was required to submit, but failed
to do so, that was not accurate, current, and complete, as required
by the Truth-in-Negotiations Act (41 U.S.C. 254b). Additionally, the
Subcontractor shall indemnify the Contractor from any liability of
the Contractor to the Federal Government due to any subcontractor
activities determined by the Government to violate subsection 27 (a),
(b), or (c) of the Office of Federal Procurement Policy act, 41 USC
§423, as amended (See FAR 52.203-10).

22

 

H.25 OPTION FOR ADDITIONAL SPECIFIED ITEMS

The Contractor may require the delivery of each of the numbered line items separately
identified in the Subcontract Schedule (Section B) as an option item, on the terms and at the
price stated in Section B. The Contracting Officer may exercise the option(s) at various times
by furnishing written notice to the Subcontractor that the option item or items are being
exercised. Except as stated below, Option Item(s) shall be exercised within thirty (30) days
after the U.S. Government provides sufficient funding to the Prime Contractor for performance
of the Milestone to which the Subcontract Item relates. Option Item(s) 0003AE (Milestone 13)
and 0003AG (Milestone 14) shall be exercised within fifteen (15) days after the later of the
date of Contractor acceptance *****.

H.26 JOINT DEVELOPMENT EFFORTS

	 	(a)	 	Subcontractor representatives shall participate in Contractor technical/regulatory
meetings with the NIH Project Officer, the FDA, or other government agencies, when
requested by the Contractor if three (3) business days advance notice of the meeting is
given to the Subcontractor.
	 
	 	(b)	 	In addition to the meetings set forth in subparagraph (a), Subcontractor
representatives from affected functional areas (manufacturing, regulatory, etc.) shall
have the right to attend any technical/regulatory meetings with the NIH Project Officer,
the FDA, or other government agencies unless the U.S. Government has requested an
“Acambis-only” meeting.
	 
	 	(c)	 	It is understood that Acambis, being the prime contractor ***** will actively lead
the discussions in any meetings with government agencies and that Baxter shall participate
as an observer to support Acambis on its request. Acambis shall give Baxter advance
notice of any technical/regulatory meetings with the U.S. Government and the agenda of
item(s) to be discussed, at least three (3) business days before the date scheduled for
the meeting, if feasible. A copy of any post-meeting minutes for matters pertaining to
product development or manufacturing shall also be provided to the Baxter Project Officer.
	 
	 	(d)	 	The Contractor shall review the plans delivered by the Subcontractor under this
Subcontract and shall provide to the Subcontractor any comments or changes proposed by the
Contractor before submitting such plans to the Government under the prime contract.
Additionally, the Contractor shall provide the Subcontractor with a copy of the final
plan(s) submitted to the Government and any Government comments made with respect to such
plans.

Section I — Subcontract Clauses 

Section I-1 — CLAUSES INCORPORATED BY REFERENCE

The Federal Acquisition Regulation (FAR) and Health And Human Services Supplemental
Acquisition Regulation (HHSAR) clauses identified herein below are hereby incorporated into
this Subcontract by reference with full force and effect. The additional HHSAR clauses
augment and supplement the FAR clauses, taking precedence thereover to any extent
inconsistent therewith.

All such clauses, as well as any other FAR or HHSAR clauses referred to elsewhere in this
Subcontract, shall with respect to the rights, duties, and obligations of the Contractor
and the Subcontractor thereunder, be interpreted and construed in such manner as to
recognize and give effect to (i) the contractual relationship between the Contractor and
Subcontractor under this Subcontract and (ii) the rights of the Government with respect
thereto under the Prime Contract from which such clauses are derived. Where rights, duties
and obligations are expressed herein as applying to the “Government,” the “United States,”
or the “Contracting Officer”, they shall generally apply by reason of the flow down to the
“Contractor”; and where expressed herein as applying to the “Contractor”, they shall
generally apply by reason of the flow down to the “Subcontractor”. However, the terms
“Government” or “Contracting Officer” do not change (i) in the phrases “Government
Property”; “Government-Owned Property,” “Government Equipment” or “Government-Owned
Equipment” except with respect to property identified in provision H.12 as
Contractor-Furnished Property; (ii) when a right, act, authorization or obligation can only
be exercised by the Government or the Contracting Officer under the prime contract or his
duly authorized representative, (iii) when title to property is to be transferred directly
to the Government and (iv) in

23

 

FAR 52.227-1 and 52.227-2. To the extent there is a conflict between the FAR or HHSAR
clauses incorporated by reference and the text of this Subcontract, the text of the
Subcontract shall have precedence.

	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.203-12

	 	Limitation on Payment to Influence Certain Federal Transactions (Jun 1997)
	52.215-17

	 	Waiver of Facilities Capital Cost of Money (Oct 1997)
	 
	 	 
	52.215-21

	 	Requirements for Cost or Pricing Data or Information Other than Cost or
Pricing Data — Modifications (Oct 1997)
	 
	 	 
	52.216-7

	 	Allowable Cost and Payment (Feb 2002) [Only paragraphs (a)(1), (g), (h)(1).
(h)(2) and (h)(2)(i)] (Applies to Item 0006 only)
	 
	 	 
	52.232-32

	 	Performance-Based Payments (Feb 2002)
	 
	 	 
	52.222-26

	 	Equal Opportunity (Feb 1999)
	52.222-35

	 	Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Dec 2001)
	52.222-36

	 	Affirmative Action for Workers with Disabilities (Jun 1998)
	52.223-3

	 	Hazardous Material Identification and Material Safety Data (Jan 1997)
(Alternate I, Jan 1997)
	 
	 	 
	52.225-1

	 	Buy American Act-Balance of Payments-Supplies (Feb 2002)
	 
	 	 
	52.225-13

	 	Restrictions on Certain Foreign Purchases (Jul 2000)
	 
	 	 
	52.227-1

	 	Authorization and Consent (Jul 1995) Alternate I (Apr 1984)
	52.227-2

	 	Notice and Assistance Regarding Patent and Copyright Infringement (Aug 1996)
	52.227-11

	 	Patent Rights — Retention by the Contractor (Short Form) (Note: In accordance
with FAR 27.303(a)(2), paragraph (f) is modified to include the requirements
in FAR 27.303(a)(2)(i) through (iv). The frequency of reporting in (i) is
annual.
	52.227-14

	 	Rights in Data — General (Jun 1987)
	52.232-1

	 	Payments (Apr 1984)
	 
	 	 
	52.232-32

	 	Performance — Based Payments (Feb 2002) (delete paragraph (c)(2))
	 
	 	 
	52.232-17

	 	Interest (Jun 1996) [Delete reference to “(net of any applicable tax credit
under the Internal Revenue Code (26 U.S.C. 1481)” in subparagraph (a) and
subparagraph (c).
	52.242-1

	 	Notice of Intent to Disallow Costs (Apr 1984) (Applies only to Item 0006)
	52.242-13

	 	Bankruptcy (Jul 1995)
	52.245-2

	 	Government Property (Fixed Price)(Dec 1989)(as implemented at Paragraph H.12)

	 	 	 
	HHSAR SOURCE	 	TITLE AND DATE (48 CFR Chapter 3)
	352.223-70

	 	Safety and Health (Jan 2001)
	352.232-9

	 	Withholding of Contract Payment (Apr 1984)
	 
	 	 
	352.224-70

	 	Confidentiality of Information ((Apr 1984)
	352.270-5

	 	Key Personnel (Apr 1984)
	352.270-6

	 	Publications and Publicity (Jul 1991)
	352.270-9

	 	Care of Live Vertebrate Animals ((Jan 2001)

Section I-2 CLAUSES IN FULL TEXT

	 	 	I.2 FAR 52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL COMPONENTS (OCT 1998)

	 	(a)	 	Definitions.

24

 

	 	 	 	“Commercial item”, as used in this clause, has the meaning contained in the clause
at 52.202-1, Definitions.
	 
	 	 	 	“Subcontract”, as used in this clause, 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 Subcontractors shall incorporate, and
require its subcontractors at all tiers to incorporate, commercial items or
non-developmental items as components of items to be supplied under this Subcontract.
	 
	 	(c)	 	The Contractor shall insert the following in subcontracts for commercial
items:

	 	(i)	 	52.219-8, Utilization of Small Business Concerns (OCT 2000)
	 
	 	(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); and

	 	 	 	 
	 
	 	(d)	 	The Subcontractor shall include the terms of this clause, including this paragraph (d), in
lower-tier subcontracts awarded under this Subcontract.

I.3 TERMINATION FOR CONVENIENCE (FIXED PRICE)

	 	(a)	 	The Contractor may terminate performance of work under this Subcontract in
whole or, from time to time, in part, if the Contractual Officer determines that a
termination is in the Contractor’s interest, but only if and to the same extent that
the Government has terminated the Contractor’s Prime Contract. The Contractual
Officer shall terminate by delivering to the Subcontractor a Notice of Termination
specifying the extent of termination and the effective date.
	 
	 	(b)	 	After receipt of a Notice of Termination, and except as directed by the
Contractual Officer, the Subcontractor(s) shall immediately proceed with the following
obligations, regardless of any delay in determining or adjusting any amounts due under
this clause:

	 	(1)	 	Stop work as specified in the notice.
	 
	 	(2)	 	Place no further subcontracts or orders (referred to as
subcontracts in this clause) for materials, services, or facilities, except
as necessary to complete the continued portion of the Subcontract.
	 
	 	(3)	 	Terminate all subcontracts to the extent they relate to the
work terminated.
	 
	 	(4)	 	Assign to the Contractor or the Government, as directed by
the Contractual Officer, all right, title, and interest of the
Subcontractor(s) under the subcontracts terminated, in which case the
Contractor shall have the right to settle or to pay any termination
settlement proposal arising out of those terminations.
	 
	 	(5)	 	With approval or ratification to the extent required by the
Contractual Officer, settle all outstanding liabilities and termination
settlement proposals arising from the termination of subcontracts; the
approval or ratification will be final for purposes of this clause.
	 
	 	(6)	 	As directed by the Contractual Officer, transfer title and
deliver to the Contractor or the Government -

	 	(i)	 	The fabricated or unfabricated parts, work
in process, completed work, supplies and other material produced or
acquired for the work terminated; and

25

 

	 	(ii)	 	The completed or partially completed plans,
drawings, information, and other property that, if the Subcontract
had been completed would be required to be furnished to the
Contractor or the Government.

	 	(7)	 	Complete performance of the work not terminated.
	 
	 	(8)	 	Take any action that may be necessary, or that the
Contractual Officer may direct, for the protection and preservation of the
property related to this Subcontract that is in the possession of the
Subcontractor(s) and in which the Contractor or the Government has or may
acquire an interest.
	 
	 	(9)	 	Use its best efforts to sell, as directed or authorized by
the Contractual Officer, any property of the types referred to in
subparagraph (b)(6) of this clause; provided, however, that the
Subcontractor(s) (i) is not required to extend credit to any purchaser and
(ii) may acquire the property under the conditions prescribed by, and at
prices approved by, the Contractual Officer. The proceeds of any transfer or
disposition will be applied to reduce any payments to be made by the
Contractor under this Subcontract, credited to the price or cost of the work,
or paid in any other manner directed by the Contractual Officer.

	 	(c)	 	The Subcontractor shall submit complete termination inventory schedules no
later than 90 days from the effective date of termination, unless extended in writing
by the Contractual Officer upon written request of the Subcontractor within this
90-day period.
	 
	 	(d)	 	After expiration of the plant clearance period as defined in Subpart 45.6 of
the Federal Acquisition Regulation, the Subcontractor may submit to the Contractual
Officer a list, certified as to quantity and quality, of termination inventory not
previously disposed of, excluding items authorized for disposition by the Contractual
Officer. The Subcontractor may request the Contractor to remove those items or enter
into an agreement for their storage. Within 30 days, the Contractor will accept title
to those items and remove them or enter into a storage agreement. The Contractual
Officer may verify the list upon removal of the items, or if stored, within 45 days
from submission of the list, and shall correct the list, as necessary, before final
settlement.
	 
	 	(e)	 	After termination, the Subcontractor shall submit a final termination
settlement proposal to the Contractual Officer in the form and with the certification
prescribed by the Contractual Officer. The Subcontractor shall submit the proposal
promptly, but no later than 240 days from the effective date of termination, unless
extended in writing by the Contractual Officer upon written request the Subcontractor
within this 240-day period. However, if the Contractual Officer determines that the
facts justify it, a termination settlement proposal may be received and acted on after
240 days or any extension. If the Subcontractor fails to submit the proposal within
the time allowed, the Contractual Officer may determine, on the basis of information
available, the amount, if any, due the Subcontractor because of the termination and
shall pay the amount determined.
	 
	 	(f)	 	Subject to paragraph (e) of this clause, the Subcontractor and the
Contractual Officer may agree upon the whole or any part of the amount to be paid or
remaining to be paid because of the termination. The amount may include a reasonable
allowance for profit on work done. However, the agreed amount, whether under this
paragraph (f) or paragraph (g) of this clause, exclusive of costs shown in
subparagraph (g)(3) of this clause, may not exceed the total Subcontract price as
reduced by (1) the amount of payments previously made and (2) the Subcontract price of
work not terminated. The Subcontract shall be modified, and the Subcontractor(s) paid
the agreed amount. Paragraph (g) of this clause shall not limit, restrict, or affect
the amount that may be agreed upon to be paid under this paragraph.
	 
	 	(g)	 	If the Subcontractor and the Contractual Officer fail to agree on the whole
amount to be paid because of the termination of work, the Contractual Officer shall
pay the Subcontractor the amounts determined by the Contractual Officer as follows,
but without duplication of any amounts agreed on under paragraph (f) of this clause:

	 	(1)	 	The Subcontract price for completed supplies or services
accepted by the Contractor (or sold or acquired under subparagraph (b)(9) of
this clause) not previously paid for, adjusted for any saving of freight and
other charges.

26

 

	 	(2)	 	The total of -

	 	(i)	 	The costs incurred in the performance of
the work terminated, including initial costs and preparatory expense
allocable thereto, but excluding any costs attributable to supplies
or services paid or to be paid under subparagraph (g)(1) of this
clause;
	 
	 	(ii)	 	The cost of settling and paying termination
settlement proposals under terminated subcontracts that are properly
chargeable to the terminated portion of the Subcontract if not
included in subdivision (g)(2)(i) of this clause; and
	 
	 	(iii)	 	A sum, as profit on subdivision (g)(2)(i)
of this clause, determined by the Contractual Officer under 49.202 of
the Federal Acquisition Regulation, in effect on the date of this
Subcontract, to be fair and reasonable; however, if it appears that
the Subcontractor(s) would have sustained a loss on the entire
Subcontract had it been completed, the Contractual Officer shall
allow no profit under this subdivision (g)(2)(iii) and shall reduce
the settlement to reflect the indicated rate of loss.

	 	(3)	 	The reasonable costs of settlement of the work terminated,
including -

	 	(i)	 	Accounting, legal, clerical, and other
expenses reasonably necessary for the preparation of termination
settlement proposals and supporting data;
	 
	 	(ii)	 	The termination and settlement of
subcontracts (excluding the amounts of such settlements); and
	 
	 	(iii)	 	Storage, transportation, and other costs
incurred, reasonably necessary for the preservation, protection, or
disposition of the termination inventory.

	 	(h)	 	Except for normal spoilage, and except to the extent that the Contractor or
the Government expressly assumed the risk of loss, the Contractual Officer shall
exclude from the amounts payable to the Subcontractor under paragraph (g) of this
clause, the fair value, as determined by the Contractual Officer, of property that is
destroyed, lost, stolen, or damaged so as to become undeliverable to the Contractor.
	 
	 	(i)	 	The cost principles and procedures of Part 31 of the Federal Acquisition
Regulation, in effect on the date of this Subcontract, shall govern all costs claimed,
agreed to, or determined under this clause.
	 
	 	(j)	 	The Subcontractor shall have the right to dispute the termination settlement
amount unilaterally established by Contractor under paragraph (e) or (g) of this
clause and any equitable adjustment unilaterally established by the Contractor under
paragraph (l), except that if the Subcontractor failed to submit the termination
settlement proposal or request for equitable adjustment within the time provided in
paragraph (e) or (l), respectively, and failed to request a time extension, there is
no right to dispute the amount allowed by the Contractor.
	 
	 	(k)	 	In arriving at the amount due the Subcontractor under this clause, there
shall be deducted

	 	(1)	 	All unliquidated advance or other payments to the
Subcontractor under the terminated portion of this Subcontract;
	 
	 	(2)	 	Any claim which the Contractor has against the
Subcontractor under this Subcontract; and
	 
	 	(3)	 	The agreed price for, or the proceeds of sale of,
materials, supplies, or other things acquired by the Subcontractor(s) or sold
under the provisions of this clause and not recovered by or credited to the
Contractor.

27

 

	 	(l)	 	If the termination is partial, the Subcontractor may file a proposal with the
Contractual Officer for an equitable adjustment of the price(s) of the continued
portion of the Subcontract. The Contractual Officer shall make any equitable
adjustment agreed upon. Any proposal by the Subcontractor for an equitable adjustment
under this clause shall be requested within 90 days from the effective date of
termination unless extended in writing by the Contractual Officer.
	 
	 	(m)	 	(1)	The Contractor may, under the terms and conditions it prescribes, make
partial payments and payments against costs incurred by the Subcontractor for the
terminated portion of the Subcontract, if the Contractual Officer believes the total
of these payments will not exceed the amount to which the Subcontractor will be
entitled.

	 	(2) 	If the total payments exceed the amount finally determined
to be due, the Subcontractor(s) shall repay the excess to the Contractor upon
demand, together with interest computed at the rate established by the
Secretary of the Treasury under 50 U.S.C. App. 1215(b)(2). Interest shall be
computed for the period from the date the excess payment is received by the
Subcontractor to the date the excess is repaid. Interest shall not be
charged on any excess payment due to a reduction in the Subcontractor’s
termination settlement proposal because of retention or other disposition of
termination inventory until 10 days after the date of the retention or
disposition, or a later date determined by the Contractual Officer because of
the circumstances.

	 	(n)	 	Unless otherwise provided in this Subcontract or by statute, the
Subcontractor shall maintain all records and documents relating to the terminated
portion of this Subcontract for 3 years after final settlement. This includes all
books and other evidence bearing on the Subcontractors’ costs and expenses under this
Subcontract. The Subcontractor shall make these records and documents available to
the Contractor and the Government, at the Subcontractors’ offices, at all reasonable
times, without any direct charge. If approved by the Contractual Officer,
photographs, microphotographs, or other authentic reproductions may be maintained
instead of original records and documents.

I.4 DEFAULT (FIXED PRICE)

	 	 	(a)(1)	The Contractor may, subject to paragraphs (c) and (d) of this clause, by written
notice of default to the Subcontractor terminate this Subcontract in whole or in part
if the Subcontractor fails to:

	 	(i)	 	Deliver the supplies or to perform the services within the
time specified in this Subcontract or any extension
	 
	 	(ii)	 	Make progress, so as to endanger performance of this
Subcontract (but see subparagraph (a)(2) of this clause); or
	 
	 	(iii)	 	Perform any of the other provisions of this Subcontract
(but see subparagraph (a)(2) of this clause).

	 	(2)	 	The Contractor’s right to terminate this Subcontract under
subdivisions (a)(1)(ii) and (1)(iii) of this clause, may be exercised if the
Subcontractor does not provide the Contractor with written assurances that it can
and will cure such failure within 10 days (or more if authorized in writing by the
Contractual Officer) after receipt of the notice from the Contractual Officer
specifying the failure. The failure of Contractor to issue such notice to the
Subcontractor, or to give the Subcontractor at least 10 days within which to cure
its failure to perform under subdivisions (a)(1)(ii) or (1)(iii), shall not be a
basis to invalidate a default termination if, in fact, the Subcontractor was
either failing to make progress so as to endanger performance or was in breach of
a material Subcontract requirement.

	 	(b)	 	If the Contractor terminates this Subcontract in whole or in part, it may
acquire, under the terms and in the manner the Contractual Officer considers
appropriate, supplies or services similar to those terminated, and the Subcontractor
shall be liable to the Contractor for any excess costs for those supplies or services.
However, the Subcontractor shall continue the work not terminated.

28

 

	 	(c)	 	Except for defaults of subcontractors at any tier, the Subcontractor(s) shall
not be liable for any excess costs if the failure to perform the Subcontract arises
from causes beyond the control and without the fault or negligence of the
Subcontractor. Examples of such causes include (1) acts of God or of the public
enemy, (2) acts of the Government in either its sovereign or contractual capacity, (3)
fires, (4) floods, (5) epidemics, (6) quarantine restrictions, (7) strikes, (8)
freight embargoes, and (9) unusually severe weather. In each instance the failure to
perform must be beyond the control and without the fault or negligence of the
Subcontractor.
	 
	 	(d)	 	If the failure to perform is caused by the default of a Subcontractor to the
Subcontractor at any tier, and if the cause of the default is beyond the control of
both the Subcontractor and any of their subcontractors, and without the fault or
negligence of either Subcontractor any of their lower-tier subcontractors, the
Subcontractor shall not be liable for any excess costs for failure to perform, unless
the subcontracted supplies or services were obtainable from other sources in
sufficient time for the Subcontractor to meet the required delivery schedule.
	 
	 	(e)	 	If this Subcontract is terminated for default, the Contractor may require the
Subcontractor(s) to transfer title and deliver to the Contractor or to the Government,
as directed by the Contractual Officer, any (1) completed supplies, and (2) partially
completed supplies and materials, parts, tools, dies, jigs, fixtures, plans, drawings,
information, and contract rights (collectively referred to as “manufacturing
materials” in this clause) that the Subcontractor has specifically produced or
acquired for the terminated portion of this Subcontract. Upon direction of the
Contractual Officer, the Subcontractor shall also protect and preserve property in its
possession in which the Contractor or the Government has an interest.
	 
	 	(f)	 	The Contractor shall pay the Subcontract price for completed supplies
delivered and accepted. The Subcontractor and Contractual Officer shall agree on the
amount of payment for manufacturing materials delivered and accepted and for the
protection and preservation of the property. The Contractor may withhold from these
amounts any sum the Contractual Officer determines to be necessary to protect the
Contractor against loss because of outstanding liens or claims of former lien holders.
	 
	 	(g)	 	If, after termination, it is determined that the Subcontractor was not in
default, or that the default was excusable, the rights and obligations of the parties
shall be the same as if the termination had been issued for the convenience of the
Contractor.
	 
	 	(h)	 	The rights and remedies of the Contractor in this clause are in addition to any other
rights and remedies provided by law or under this Subcontract.

I.5 Care of Live Vertebrate Animals

The following notice is applicable when subcontract performance is expected to involve
care of live vertebrate animals:

The Public Health Service (PHS) Policy on Human Care and Use of Laboratory Animals
establishes a number of requirements for research activities involving animals. Before
a PHS award may be made to an applicant organization, the organization shall file, with
the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW),
National Institutes of Health (NIH), PHS, a written Animal Welfare Assurance which
commits the organization to comply with the provisions of the PHS Policy on Humane Care
and Use of Laboratory Animals by Awardee Institutions, the Animal Welfare Act, and the
Guide for the Care and Use of Laboratory Animals prepared by the Institute of
Laboratory Animal Resources. In accordance with the PHS Policy on Humane Care and Use
of Laboratory Animals by Awardee Institutions, applicant organizations must establish a
committee, qualified through the experience and expertise of its members, to oversee
the institution’s animal program, facilities and procedures. No PHS award involving
the use of animals shall be made unless the Animal Welfare Assurance has been approved
by OER. Prior to award, the Contracting Officer will notify Contractor(s) selected for
projects that involve live vertebrate animals that an Animal Welfare Assurance is
required. The Contracting Officer will request that OER, OLAW negotiate an acceptable
Animal Welfare Assurance with those Contractor(s). For further information, OER,

29

 

OLAW, may be contacted at Rockledge Center I — Suite 1050, 6705 Rockledge Drive,
Bethesda, MD 20817, (301) 496-7163, ext 234. FAX copies are of the PHS Policy are
available at (301) 402-2803. This policy is also available on the internet at
http://www.grants.nih.gov/grants/olaw/olaw.htm.

Section J — List Of Attachments

A            Statement
of Work

B            Subcontractors’ Certifications, Representations, and Other Statements

SECTION J, ATTACHMENT A

STATEMENT OF WORK

The following Contract Line Items (CLINs) shall be performed by the Subcontractor to satisfy the
efforts associated with the noted Milestones set out in the statement of work issued by the NIH.
In the case of any discrepancies with the noted Milestones and this Agreement, this Agreement shall
prevail.

CLIN 0001- Process Development, Validation, and Manufacturing

     AA Product Development Plan (PDP) (Milestone 1)

The Product Development Plan *****

     AB Product Development Plan (PDP) and Quality Systems Plan (QSP) Updates (Milestone
17) 

Update the PDP (Item 0001AA) and QSP (Item 0001AC) after manufacture *****

     AC Quality Systems Plan (QSP) (Milestone 2) 

The QSP shall describe *****

30

 

     AD Regulatory Support Plan (Manufacturing) (Milestone 5)

The Regulatory Support Plan shall describe *****

     AE Updated Regulatory Support Plan (Milestone 16) 

Update the Regulatory Support Plan *****

     AF Summary Report (Milestone 6)

A summary report shall be prepared and submitted *****

     AG Manufacture and Delivery *****

*****

*****

31

 

     AH Small-Scale Investigation for a Lyophilized Product (Milestone 1)

Conduct a lyophilization study *****

CLIN 0002- Vaccine Stockpile Maintenance Plan

	 	AA.	 	 Develop a plan to maintain, test, and replenish the MVA vaccine in the
U.S. Government stockpile for the term of the Prime Contract (Estimate: Until 36
months after Subcontract Award) (Milestone 8) 

This plan shall address all considerations necessary to *****

CLIN 0003- Large-Scale Manufacturing

     AA Large-Scale Production Plan (LPP) (Milestone 9)

Submit to Acambis a Large-Scale Production Plan (LPP) *****

*****

*****

32

 

     AB Manufacture Purified Bulk MVA – Deliver Sufficient Volume *****

Manufacture sufficient purified bulk vaccine *****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

	 	•	 	*****
	 
	 	•	 	*****

33

 

***** 

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	 
	 	*****	 	*****
	*****
	 	*****	 	*****
	 
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

34

 

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

35

 

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

*****

     AC Additional *****

If the***** delivered under *****

     AD Formulate, fill and finish Item 0003AB. *****

*****

36

 

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

	 	 	 	 	 
	 *****	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****
	*****
	 	*****	 	*****

*****

*****

*****

37

 

     AE. Formulate, fill and finish *****

*****

     AF Deliver Vials of Filled Vaccine (2.5 million Doses) (Milestone 14)

Ship Baxter *****

     AG Deliver Vials of Filled Vaccine (500,000 Doses) (Milestone 14)

Ship Baxter- *****

CLIN 0004- Stockpile Maintenance/Stability Studies

     AA Stability Program (Milestone 18)

Perform stability testing of purified bulk vaccine to *****

*****

*****

38

 

CLIN 0005- Replenishment Vaccine (Milestone 18)

     AA Deliver Replacement Single-Dose vials of MVA (As Ordered)

Vaccine vials *****

*****

CLIN 0006 – Provide any and all travel necessary to accomplish the work identified above. Actual
costs for travel are reimbursed in amounts not to exceed allowable costs under FAR.

Overall Requirement (Applicable to all Items): All manufacturing activities shall be
performed in accordance with *****

39

 

SECTION K – CERTIFICATIONS, REPRESENTATIONS AND OTHER STATEMENTS

Representations, Certifications, and Other Statements of Offerors or Quoters
(Negotiated).

1. FAR 52.203-2 Certification of Independent Price Determination

2. FAR 52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal
Transactions (DEVIATION)

3. FAR 52.204-3 Taxpayer Identification

4. FAR 52.204-5 Women-Owned Business (Other Than Small Business)

5. FAR 52.204-6 Data Universal Numbering System (DUNS) Number

6. FAR 52.209-5 Certification Regarding Debarment, Suspension, Proposed Debarment and Other
Responsibility Matters

7. FAR 52.215-6 Place of Performance

8. FAR 52.215-16 Facilities Capital Cost of Money

9. FAR 52.219-1 Small Business Program Representations

10. FAR 52.219-19 Small Business Concern Representation for the Small Business Competitiveness
Demonstration Program

11. FAR 52.219-21 Small Business Size Representation for Targeted Industry Categories Under the
Small Business Competitiveness Demonstration Program

12. FAR 52.219-22 Small Disadvantaged Business Status

13. FAR 52.222-18 Certification Regarding Knowledge of Child Labor for Listed End Products

14. FAR 52.222-21 Certification of Nonsegregated Facilities

15. FAR 52.222-22 Previous Contracts and Compliance Reports

16. FAR 52.222-25 Affirmative Action Compliance

17. FAR 52.222-38 Compliance with Veterans’ Employment Reporting Requirements

18. FAR 52.222-48 Exemption From Application of Service Contract Act Provisions

19. FAR 52.223-4 Recovered Material Certification

20. FAR 52.225-2 Buy American Act Certificate

21. FAR 52.226-2 Historically Black College or University and Minority Institution Representation

22. FAR 52.227-6 Royalty Information

23. FAR 52.230-1 Cost Accounting Standards Notices and Certification

24. —— Certification of Institutional Policy on Conflict of Financial Interest

To Be Completed by the Offeror: (The Representations and Certifications must be executed by an
individual authorized to bind the offeror.) The offeror makes the following Representations and
Certifications as part of its proposal (check/complete all appropriate boxes or blanks on the
following pages).

	 	 	 
	 
	 	 
	 

	 	 
	(Name of Offeror)

	 	(RFP No.)
	 
	 	 
	

	 	(Date):
	(Signature of Authorized Individual)
	 	 
	 
	 	 
	

	 	Note: The penalty for making false
statements in offers is prescribed in USC 1001
	18 (Typed Name of Authorized Individual)
	 	 

40

 

K.1 52.203-2 CERTIFICATE OF INDEPENDENT PRICE DETERMINATION (APRIL 1985)

[NOTE: This provision is applicable when a firm-fixed price or fixed-price with economic price
adjustment contract is contemplated.]

(a) The offeror certifies that -

(1) The prices in this offer have been arrived at independently, without, for the purpose of
restricting competition, any consultation, communication, or agreement with any other offeror or
competitor relating to (i) those prices, (ii) the intention to submit an offer, or (iii) the
methods or factors used to calculate the prices offered;

(2) The prices in this offer have not been and will not be knowingly disclosed by the offeror,
directly or indirectly, to any other offeror or competitor before bid opening (in the case of a
sealed bid solicitation) or contract award (in the case of a negotiated solicitation) unless
otherwise required by law; and

(3) No attempt has been made or will be made by the offeror to induce any other concern to submit
or not to submit an offer for the purpose of restricting competition.

(b) Each signature on the offer is considered to be a certification by the signatory that the
signatory—

(1) Is the person in the offeror’s organization responsible for determining the prices being
offered in this bid or proposal, and that the signatory has not participated and will not
participate in any action contrary to subparagraphs (a)(1) through (a)(3) above; or

(2) (i) Has been authorized in writing, to act as agent for the following principals in certifying
that those principals have not participated, and will not participate in any action contrary to
subparagraphs (a)(1) through (a)(3) above

 

 

[insert full name of person(s) in the offeror’s organization responsible for determining the prices
offered in this bid or proposal, and the title of his or her position in the offeror’s
organization];

(ii) As an authorized agent, does certify that the principals named in subdivision (b)(2)(i) above
have not participated, and will not participate, in any action contrary to subparagraphs (a)(1)
through (a)(3) above; and

(iii) As an agent, has not personally participated, and will not participate, in any action
contrary to subparagraphs (a)(1) through (a)(3) above.

(c) If the offeror deletes or modifies subparagraph (a)(2) above, the offeror must furnish with its
offer a signed statement setting forth in detail the circumstances of the disclosure.

41

 

K.2 52.203-11 CERTIFICATION AND DISCLOSURE REGARDING PAYMENTS TO INFLUENCE CERTAIN FEDERAL
TRANSACTIONS (DEVIATION)

(a) The definitions and prohibitions contained in the clause, at FAR 52.203-12, Limitations on
Payments to Influence Certain Federal Transactions, included in this solicitation, are hereby
incorporated by reference in paragraph (b) of this certification.

(b) The offeror, by signing its offer, hereby certifies to the best of his or her knowledge
and belief that on or after December 23, 1989 -

(1) No Federal appropriated funds have been paid or will be paid, to any person for influencing or
attempting to influence an officer or employee of any agency, a Member of Congress, an officer or
employee of Congress, or an employee of a Member of Congress on his or her behalf in connection
with the awarding of a contract resulting from this solicitation.

(2) If any funds other than Federal appropriated funds (including profit or fee received under a
covered Federal transaction) have been paid, or will be paid, to any person for influencing or
attempting to influence an officer or employee of any agency, a Member of Congress, an officer or
employee of Congress, or an employee of a Member of Congress on his or her behalf in connection
with this solicitation, the offeror shall complete and submit with its offer, OMB Standard
Form-LLL, “Disclosure of Lobbying Activities”, to the Contracting Officer, and

(3) He or she will include the language of this certification in all subcontract awards at any
tier and require that all recipients of subcontract awards in excess of $100,000 shall certify and
disclose accordingly.

(c) Submission of this certification and disclosure is a prerequisite for making or entering
into this contract imposed by section 1352, Title 31, United States Code. Any person who makes an
expenditure prohibited under this provision or who fails to file or amend the disclosure form to be
filed or amended by this provision, shall be subject to a civil penalty of not less than $10,000,
and not more than $100,000, for each such failure.

K.3 FAR 52.204-3 TAXPAYER IDENTIFICATION (OCT 1998)

(a) Definitions.

“Common parent,” as used in this solicitation provision, means that corporate entity that owns or
controls an affiliated group of corporations that files its Federal income tax returns on a
consolidated basis, and of which the offeror is a member.

“Taxpayer Identification Number (TIN),” as used in this provision, means the number required by the
Internal Revenue Service (IRS) to be used by the offeror in reporting income tax and other returns.
The TIN may be either a Social Security Number or an Employer Identification Number.

(b) All offerors must submit the information required in paragraphs (d) through (f) of this
provision to comply with debt collection requirements of 31 U.S.C. 7701(c) and 3325(d), reporting
requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the IRS.
If the resulting contract is subject to the payment reporting requirements described in Federal
Acquisition Regulation (FAR) 4.904, the failure or refusal by the offeror to furnish the
information may result in a 31 percent reduction of payments otherwise due under the contract.

(c) The TIN may be used by the Government to collect and report on any delinquent amounts arising
out of the offeror’s relationship with the Government (31 U.S.C. 7701(c)(3)). If the resulting
contract is subject to the payment reporting requirements described in FAR 4.904, the TIN provided
hereunder may be matched with IRS records to verify the accuracy of the offeror’s TIN.

42

 

(d) Taxpayer Identification Number (TIN).

[  ] TIN:                                         

[  ] TIN has been applied for.

[  ] TIN is not required because:

_______ Offeror is a nonresident alien, foreign corporation, or foreign partnership that does not
have income effectively connected with the conduct of a trade or business in the United States and
does not have an office or place of business or a fiscal paying agent in the United States;

_______Offeror is an agency or instrumentality of a foreign government;

_______Offeror is an agency or instrumentality of a Federal Government.

(e) Type of organization.

___Sole proprietorship;

___Partnership;

___Corporate entity (not tax-exempt);

___Corporate entity (tax-exempt);

___Government entity (Federal, State, or local);

___Foreign government;

___International organization per 26 CFR 1.6049-4;

___Other:                                                            

(f) Common Parent.

     [  ]
Offeror is not owned or controlled by a common parent as defined
in paragraph

(a) of this provision.

     [  ] Name and TIN of common parent:

Name:                                                                                                    

TIN:                                                            

K.4 52.204-5 WOMEN-OWNED BUSINESS (Other Than Small Business) (MAY 1999)

(a) Definition. Women-owned business concern, as used in this provision, means a concern that is at
least 51 percent owned by one or more women; or in the case of any publicly owned business, at
least 51 percent of its stock is owned by one or more women; and whose management and daily
business operations are controlled by one or more women.

(b) Representation. [Complete only if the offeror is a women-owned business concern and has not
represented itself as a small business concern in paragraph (b)(1) of FAR 52.219-1, Small Business
Program Representations, of this solicitation.]

     The offeror represents that it [  ] is a women-owned business concern.

43

 

K.5 52.204-6 DATA UNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER (JUNE 1999)

(a) The offeror shall enter, in the block with its name and address on the cover page of its offer,
the annotation “DUNS” followed by the DUNS number that identifies the offeror’s name and address
exactly as stated in the offer. The DUNS number is a nine-digit number assigned by Dun and
Bradstreet Information Services.

(b) If the offeror does not have a DUNS number, it should contact Dun and Bradstreet directly to
obtain one. A DUNS number will be provided immediately by telephone at no charge to the offeror.
For information on obtaining a DUNS number, if located within the United States, the offeror should
call Dun and Bradstreet at 1-800-333-0505. The offeror should be prepared to provide the following
information:

(1) Company name.

(2) Company address.

(3) Company telephone number.

(4) Line of business.

(5) Chief executive officer/key manager.

(6) Date the company was started.

(7) Number of people employed by the company.

(8) Company affiliation.

(c) Offerors located outside the United States may obtain the location and phone number of the
local Dun and Bradstreet Information Services office from the Internet home page at
http://www.customerservice@dnb.com. If an offeror is unable to locate a local service center, it
may send an e-mail to Dun and Bradstreet at globalinfo@mail.dnb.com.

K.6 52.209-5 CERTIFICATION REGARDING DEBARMENT, SUSPENSION, PROPOSED SUSPENSION, PROPOSED
DEBARMENT AND OTHER RESPONSIBILITY MATTERS (DECEMBER 2001)

(NOTE: Applies to contracts expected to exceed $100,000.)

(a) (1) The Offeror certifies, to the best of its knowledge and belief, that -

(i) The Offeror and/or any of its Principals —

(A) Are [  ], are not [  ] presently debarred, suspended, proposed for debarment, or declared
ineligible for the award of contracts by any Federal agency;

(B) Have [  ], have not [  ], within a three-year period preceding this offer, been convicted of or
had a civil judgment rendered against them for: commission of fraud or a criminal offense in
connection with obtaining, attempting to obtain, or performing a public (Federal, state or local)
contract or subcontract; violation of Federal or state antitrust statutes relating to the
submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or
destruction of records, making false statements, tax evasion, or receiving stolen property; and

(C) Are [  ], are not [  ] presently indicted for, or otherwise criminally or civilly charged by a
governmental entity with, commission of any of the offenses enumerated in subdivision (a)(1)(i)(B)
of this provision.

(B) If the offeror has responded affirmatively, the offeror shall provide additional information if
requested by the Contracting Officer; and

(ii) The Offeror has [  ], has not [  ], within a three-year period preceding this offer, had one
or more contracts terminated for default by any Federal agency.

44

 

(2) “Principals” for the purposes of this certification, means officers; directors; owners;
partners; and, persons having primary management or supervisory responsibilities within a business
entity (e.g., general manager, plant manager, head of a subsidiary, division, or business segment,
and similar positions).

THIS CERTIFICATION CONCERNS A MATTER WITHIN THE JURISDICTION OF AN AGENCY OF THE UNITED STATES AND
THE MAKING OF A FALSE, FICTITIOUS, OR FRAUDULENT CERTIFICATION MAY RENDER THE MAKER SUBJECT TO
PROSECUTION UNDER SECTION 1001, TITLE 18, UNITED STATES CODE.

(b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time
prior to contract award, the Offeror learns that its certification was erroneous when submitted or
has become erroneous by reason of changed circumstances.

(c) A certification that any of the items in paragraph (a) of this provision exists will not
necessarily result in withholding of an award under this solicitation. However, the certification
will be considered in connection with a determination of the Offeror’s responsibility. Failure of
the Offeror to furnish a certification or provide such additional information as requested by the
Contracting Officer may render the Offeror nonresponsible.

(d) Nothing contained in the foregoing shall be construed to require establishment of a system of
records in order to render, in good faith, the certification required by paragraph (a) of this
provision. The knowledge and information of an Offeror is not required to exceed that which is
normally possessed by a prudent person in the ordinary course of business dealings.

(e) The certification in paragraph (a) of this provision is a material representation of fact upon
which reliance was placed when making an award. If it is later determined that the Offeror
knowingly rendered an erroneous certification, in addition to other remedies available to the
Government, the Contracting Officer may terminate the contract resulting from this solicitation for
default.

K.7 FAR 52.215-6 PLACE OF PERFORMANCE (OCT 1997)

(a) The offeror or respondent, in the performance of any contract resulting from this solicitation,
[  ] intends, [  ] does not intend [check applicable block] to use one or more plants or
facilities located at a different address from the address of the offeror or respondent as
indicated in this proposal or response to request for information.

(b) If the offeror or respondent checks “intends” in paragraph (a) of this provision, it shall
insert in the following spaces the required information:

	 	 	 
	PLACE OF PERFORMANCE

	 	NAME AND ADDRESS OF
	OWNER AND
	 	 
	STREET ADDRESS, CITY, STATE, COUNTY,

	 	OPERATOR OF THE PLANT OR
	COUNTY, ZIP CODE)

	 	FACILITY IF OTHER THAN
	OFFEROR
	 	 
	 

	 	OR RESPONDENT

45

 

K.8 52.215-16 FACILITIES CAPITAL COST OF MONEY (OCTOBER 1997)

(a) Facilities capital cost of money [(see FAR 15.408(h)] will be an allowable cost under the
contemplated contract, if the criteria for allowability in subparagraph 31.205-10(a)(2) of the
Federal Acquisition Regulation are met. One of the allowability criteria requires the prospective
Contractor to propose facilities capital cost of money in its offer.

If the offeror elects to claim this cost, the offeror shall specifically identify or propose it in
the cost proposal for the contract by checking the appropriate box below.

[  ]The prospective Contractor has specifically identified or proposed facilities capital cost of
money in its cost proposal and elects to claim this cost as an allowable cost under the contract.
Submit Form CASB-CMF (see FAR 31.205-10).

[  ] The prospective Contractor has not specifically identified or proposed facilities capital cost
of money in its proposal and elects not to claim it as an allowable cost under the contract.

(b) If the prospective Contractor does not propose this cost, the resulting contract will include
the clause “Waiver of Facilities Capital Cost of Money,” FAR 52.215-17.

K.9 52.219-1 SMALL BUSINESS PROGRAM REPRESENTATIONS (APRIL 2002)

(Note: This provision applies to solicitations exceeding the micro-purchase threshold when the
contract is to be performed in the United States, its territories or possessions, Puerto Rico, the
Trust Territory of the Pacific Islands, or the District of Columbia.)

(a) (1) The North American Industry Classification System (NAICS) code for this acquisition is
54171

     (2) The small business size standard is 500 employees

(3) The small business size standard for a concern which submits an offer in its own name, other
than on a construction or service contract, but which proposes to furnish a product which it did
not itself manufacture, is 500 employees.

(b) Representations.

(1) The offeror represents as part of its offer that it [  ] is, [  ] is not a small business
concern.

(2) (Complete only if the offeror represented itself as a small business concern in paragraph
(b)(1) of this provision.) The offeror represents, for general statistical purposes, that it [  ]
is, [  ] is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(3) (Complete only if the offeror represented itself as a small business concern in paragraph
(b)(1) of this provision.) The offeror represents as part of its offer that it [  ] is, [  ] is not
a women-owned small business concern.

(4) (Complete only if the offeror represented itself as a small business concern in paragraph
(b)(1) of this provision.) The offeror represents as part of its offer that it [  ] is, [  ] is not
a veteran-owned small business concern.

(5) (Complete only if the offeror represented itself as a veteran-owned small business concern in
paragraph (b)(4) of this provision.) The offeror represents as part of its offer that it [  ] is,
[  ] is not a service-disabled veteran owned small business concern.

(6) (Complete only if the offeror represented itself as a small business concern in paragraph
(b)(1) of this provision.) The offeror represents , as a part of its offeror, that–

46

 

(i) It [  ] is, [  ] is not a HUBZone small business concern listed, on the date of this
representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small
business Administration, and no material change in ownership and control, principal office, or
HUBZone employee percentage has occurred since it was certified by the Small Business
Administration in accordance with 13 CFR part 126; and

(ii) It [  ] is, [  ] is not a joint venture that complies with the requirements of 13 CFR part
126, and the representation in paragraph (b)(6)(i) of this provision is accurate for the HUBZone
small business concern or concerns that are participating in the joint venture. [The offeror shall
enter the name or names of the HUBZone small business concern or concerns that are participating in
the joint venture: _______________________________________] Each HUBZone small business concern
participating in the joint venture shall submit a separate signed copy of the HUBZone
representation.

(c) Definitions. As used in this provision—

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—(i) Not less than 51 percent of which is owned by one or more
service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent
of the stock or which is owned by one or more service-disabled veterans; and
(ii) The Management and daily business operation of which are controlled by one or more
service-disabled veterans or, in the case of a veteran with permanent and severe disability, the
spouse or permanent caregiver of such veteran.
(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability
that is service connected, as defined in 38 U.S.C. 101(16).

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

Women-owned small business concern, means a small business concern-
(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned
business, at least 51 percent of the stock of which is owned by
one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Veteran-owned small business concern means a small business concern—
(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S. C.
101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of
which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

(d) Notice.

(1) If this solicitation is for supplies and has been set aside, in whole or in part, for small
business concerns, then the clause in this solicitation providing notice of the set-aside contains
restrictions on the source of the end items to be furnished.

(2) Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a small, HUBZone small,
small disadvantaged, or women-owned small business concern in order to obtain a contract to be
awarded under the preference programs established pursuant to section 8(a), 8(d), 9, or 15 of the
Small Business Act or any other provision of Federal law that specifically references section 8(d)
for a definition of program eligibility, shall—

     (i) Be punished by imposition of fine, imprisonment, or both;

47

 

     (ii) Be subject to administrative remedies, including suspension and debarment; and

     (iii) Be ineligible for participation in programs conducted under the authority of the Act.

K.10 52.219-19 SMALL BUSINESS CONCERN REPRESENTATION FOR THE SMALL BUSINESS COMPETITIVENESS
DEMONSTRATION PROGRAM (OCTOBER 2000)

(This representation must be completed if the acquisition is for one of the four designated
industry groups of the Small Business Competitiveness Demonstration Program specified in FAR
19.1005(a)[includes Construction Contracts under NAICS codes that comprise Industry Subsectors 233,
234 and 235].)

—NOT APPLICABLE—

(a) Definition

“Emerging small business” as used in this solicitation, means a small business concern whose size
is no greater than 50 percent of the numerical size standard applicable to the North American
Industry Classification System (NAICS) code assigned to a contracting opportunity.

(b) (Complete only if offeror has represented itself under the provision at FAR 52.219-1 as a small
business concern under the size standards of this solicitation.)

     The Offeror [  ] is, [X] is not an emerging small business.

(c) (Complete only if the Offeror is a small business or an emerging small business, indicating its
size range.)

Offeror’s number of employees for the past twelve months (check this column if size standard stated
in solicitation is expressed in terms of number of employees) or Offeror’s average annual gross
revenue for the last 3 fiscal years (Check this column if size standard stated in solicitation is
expressed in terms of annual receipts). (Check one of the following.)

	 	 	 
	Number of Employees	 	Average Annual Gross Revenues
	[  ] 50 or fewer

	 	[  ] $1 million or less
	[  ] 51 – 100

	 	[  ]
$1,000,001 — $2 million

	[  ] 101 – 250

	 	[  ]
$2,000,001 — $3.5 million

	[  ] 251 – 500

	 	[  ]
$3,500,001 — $5 million

	[  ] 501 – 750

	 	[  ]
$5,000,001 — $10 million

	[  ] 751 — 1,000

	 	[  ]
$10,000,001 — $17 million

	[  ] Over 1,000

	 	[  ]
Over $17 million

48

 

K.11 52.219-21 SMALL BUSINESS SIZE REPRESENTATION FOR TARGETED INDUSTRY CATEGORIES UNDER THE
SMALL BUSINESS COMPETITIVENESS DEMONSTRATION PROGRAM (MAY 1999)

(Complete only if the Offeror has represented itself under the provision 52.219-1 as a small
business concern under the size standards of this solicitation.)

(NOTE: This representation must be completed if this solicitation covers one of the ten targeted
industry categories under the Small Business Competitiveness Demonstration Program and if the
offeror has certified itself under the clause at FAR 52.219-1 to be a small business concern under
the size standards of this solicitation).

—NOT APPLICABLE—

Offeror’s number of employees for the past twelve months (check this column if size standard stated
in solicitation is expressed in terms of number of employees) or Offeror’s average annual gross
revenue for the last three fiscal years (check this column if size standard stated in solicitation
is expressed in terms of annual receipts). (Check one of the following.)

	 	 	 
	No. of Employees	 	Average Annual Gross Revenues
	o 50 or fewer

	 	o $1 million or less
	o 51 – 100

	 	o $1,000,001 — $2 million
	o 101 –250

	 	o $2,000,001 — $3.5 million
	o 251 – 500

	 	o $3,500,001 — $5 million
	o 501 – 750

	 	o $5,000,001 — $10 million
	o 751 — 1,000

	 	o $10,000,001 — $17 million
	o Over 1,000

	 	o Over $17 million

The ten targeted industries are as follows:

	 	 	 	 	 	 	 
	Product	 	SIC Code	 	Description
	Service Code	 	 	 	 	 	 
	G004

	 	 	8742	 	 	Counseling/Training/Social Rehabilitation Services
	J099

	 	 	7699	 	 	Maintenance, Repair and Rebuilding of Equipment (Office
	 

	 	 	 	 	 	Machines, Text Processing Systems & Visible Record Equipment)
	K099

	 	 	7699	 	 	Modification of Equipment (misc.)
	Q210

	 	 	8099, 8742	 	 	General Health Care Services
	R406

	 	 	8742	 	 	Policy Review/Development Services
	R497

	 	 	7299	 	 	Personal Services
	6505

	 	 	2833, 2834	 	 	Drugs and Biologics
	 

	 	 	2835, 2836	 	 	 
	7045

	 	 	3572, 3695	 	 	ADP Supplies
	 

	 	 	5065	 	 	 
	7110

	 	 	5021	 	 	Office Furniture
	7510

	 	 	5112	 	 	Office Supplies

49

 

K.12 52.219-22 SMALL DISADVANTAGED BUSINESS STATUS (OCTOBER 1999)

(Note: This applies to competitive solicitations over $100,000 under the SIC Major Groups for which
a price evaluation adjustment is applicable.)

—NOT APPLICABLE—

(a) General. This provision is used to assess an offeror’s small disadvantaged business status for
the purpose of obtaining a benefit on this solicitation. Status as a small business and status as a
small disadvantaged business for general statistical purposes is covered by the provision at FAR
52.219-1, Small Business Program Representation.

(b) Representations.

(1) General. The offeror represents, as part of its offer, that it is a small business under the
size standard applicable to this acquisition; and either—

o (i) It has received certification by the Small Business Administration as a small
disadvantaged business concern consistent with 13 CFR 124, Subpart B; and

(A) No material change in disadvantaged ownership and control has occurred since its certification;

(B) Where the concern is owned by one or more disadvantaged individuals, the net worth of each
individual upon whom the certification is based does not exceed $750,000 after taking into account
the applicable exclusions set forth at 13 CFR 124.104(c)(2); and

(C) It is identified, on the date of its representation, as a certified small disadvantaged
business concern in the database maintained by the Small Business Administration (PRO-Net); or

o (ii) It has submitted a completed application to the Small Business Administration or a
Private Certifier to be certified as a small disadvantaged business concern in accordance with 13
CFR 124, Subpart B, and a decision on that application is pending, and that no material change in
disadvantaged ownership and control has occurred since its application was submitted.

(2) o For Joint Ventures. The offeror represents, as part of its offer, that it is a joint
venture that complies with the requirements at 13 CFR 124.1002(f) and that the representation in
paragraph (b)(1) of this provision is accurate for the small disadvantaged business concern that is
participating in the joint venture. [The

offeror shall enter the name of the small disadvantaged business concern that is participating in
the joint venture:                                                                                 .]

(c) Penalties and Remedies. Anyone who misrepresents any aspects of the disadvantaged status of a
concern for the purposes of securing a contract or subcontract shall:

          (1) Be punished by imposition of a fine, imprisonment, or both;

          (2) Be subject to administrative remedies, including suspension and debarment; and

          (3) Be ineligible for participation in programs conducted under the authority of the Small

          Business Act.

Alternate I (OCTOBER 1998)

(Note: Applies when price evaluation adjustment for small disadvantaged business concerns is
authorized on a regional basis. Designated regions by Major SIC Category can be found at
http://www.arnet.gov/References/sdbadjustments.htm . Currently, this includes SIC Major Industry
Groups 15, 16, 17, which are all construction related groups.)

50

 

As prescribed in 19.306(b), add the following paragraph (b)(3) to the basic provision:

(3) Address. The offeror represents that its address___is, ___is not in a region for
which a small disadvantaged business procurement mechanism is authorized and its address has not
changed since its certification as a small disadvantaged business concern or submission of its
application for certification. The list of authorized small disadvantaged business procurement
mechanisms and regions is posted at http://www.arnet.gov/References/sdbadjustments.htm The offeror
shall use the list in effect on the date of this solicitation. “Address,” as used in this
provision, means the address of the offeror as listed on the Small Business Administration’s
register of small disadvantaged business concerns or the address on the completed application that
the concern has submitted to the Small Business Administration or a Private Certifier in accordance
with 13 CFR part 124, subpart B. For joint ventures, “address” refers to the address of the small
disadvantaged business concern that is participating in the joint venture.

	K.13.	 	52.222-18 CERTIFICATION REGARDING KNOWLEDGE OF CHILD LABOR FOR LISTED END PRODUCTS (MAY
2001)

     (Applies to all contracts for supplies over $2,500. See FAR 22.1503 for more information)

—NOT APPLICABLE—

a. Definition.

     Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its
nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can
be accomplished by process or penalties.

b. Listed end products. The following end product(s) being acquired under this solicitation is
(are) included in the List of Products Requiring Contractor Certification as to Forced or
Indentured Child Labor, identified by their country of origin. There is a reasonable basis to
believe that listed end products from the listed countries of origin may have been mined, produced,
or manufactured by forced or indentured child labor.

	 	 	 
	Listed End Product

	 	Listed Countries of Origin
	          NONE                    

	 	          N/A                    
	                    

	 	                    

c. Certification. The Government will not make award to an offeror unless the offeror, by checking
the appropriate block, certifies to either paragraph (c)(1) or paragraph (c)(2) of this provision.

o (1) The offeror will not supply any end product listed in paragraph (b) of this provision that
was mined, produced, or manufactured in a corresponding country as listed for that end product.

o (2) The offeror may supply an end product listed in paragraph (b) of this provision that was
mined, produced, or manufactured in the corresponding country as listed for that product. The
offeror certifies that it has made a good faith effort to determine whether forced or indentured
child labor was used to mine, produce, or manufacture such end product. On the basis of those
efforts, the offeror certifies that it is not aware of any such use of child labor.

51

 

K.14 52.222-21 CERTIFICATION OF NONSEGREGATED FACILITIES (FEBRUARY 1999)

(a) Segregated facilities, as used in this clause, means any waiting rooms, work areas, rest rooms
and wash rooms, restaurants and other eating areas, time clocks, locker rooms and other storage or
dressing areas, parking lots, drinking fountains, recreation or entertainment areas,
transportation, and housing facilities provided for employees, that are segregated by explicit
directive or are in fact segregated on the basis of race, color, religion, sex, or national origin
because of written or oral policies or employee custom. The term does not include separate or
single-user rest rooms or necessary dressing or sleeping areas provided to assure privacy between
the sexes.

(b) The Contractor agrees that it does not and will not maintain or provide for its employees any
segregated facilities at any of its establishments, and that it does not and will not permit its
employees to perform their services at any location under its control where segregated facilities
are maintained. The Contractor agrees that a breach of this clause is a violation of the Equal
Opportunity clause in this contract.

(c) The Contractor shall include this clause in every subcontract and purchase order that is
subject to the Equal Opportunity clause of this contract.

K.15 FAR 52.222-22 PREVIOUS CONTRACTS AND COMPLIANCE REPORTS (FEB 1999)

     The offeror represents that

(a) It o has o has not participated in a previous contract or subcontract subject either to
the Equal opportunity clause of this solicitation, the clause originally contained in Section 310
of Executive Order No. 10925, or the clause contained in Section 201 of Executive order No. 11114;

(b) It o has o has not filed all required compliance reports; and

(c) Representations indicating submission of required compliance reports, signed by proposed
subcontractors, will be obtained before subcontract awards.

K.16 FAR 52.222-25 AFFIRMATIVE ACTION COMPLIANCE (APR 1984)

     The offeror represents that

(a) It o has developed and has on file o has not developed and does not have on file, at
each establishment, affirmative action programs required by the rules and regulations of the
Secretary of Labor (41 CFR 60-1 and 60-2); or

(b) it o has not previously had contracts subject to the written affirmative action programs
requirement of the rules and regulations of the Secretary of Labor.

	K.17	 	52.222-38 COMPLIANCE WITH VETERANS’ EMPLOYMENT REPORTING REQUIREMENTS (DECEMBER 2001)

—NOT APPLICABLE—

By submission of its offer, the offeror represents that, if it is subject to the reporting
requirements of 38 U.S.C. 4212(d) (i.e., if it has any contract containing Federal Acquisition
Regulation clause 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the
Vietnam Era, and Other Eligible Veterans), it has submitted the most recent VETS-100 Report
required by that clause.

52

 

	K.18.	 	52.222-48 EXEMPTION FROM APPLICATION OF SERVICE CONTRACT ACT PROVISIONS FOR CONTRACTS FOR
MAINTENANCE, CALIBRATION, AND/OR REPAIR OF CERTAIN INFORMATION TECHNOLOGY, SCIENTIFIC AND
MEDICAL AND/OR OFFICE AND BUSINESS EQUIPMENT—CONTRACTOR CERTIFICATION (AUGUST 1996)

(NOTE: This clause is applicable to all solicitations and resultant contracts calling for
maintenance, calibration, and/or repair of information technology, scientific and medical, and
office and business equipment if the contracting officer determines that the resultant contract may
be exempt from Service Contract Act coverage).

—NOT APPLICABLE—

(a) The following certification shall be checked:

CERTIFICATION

The offeror certifies o, does not certify o that: (1) The items of equipment to be serviced
under this contract are commercial items which are used regularly for other than Government
purposes, and are sold or traded by the Contractor in substantial quantities to the general public
in the course of normal business operations; (2) The contract services are furnished at prices
which are, or are based on, established catalog or market prices for the maintenance, calibration,
and/or repair of certain information technology, scientific and medical, and/or office and business
equipment. An “established catalog price” is a price (including discount price) recorded in a
catalog, price list schedule, or other verifiable and established record that is regularly
maintained by the manufacturer or the Contractor and is either published or otherwise available for
inspection by customers. An “established market price” is a current price, established in the usual
course of ordinary and usual trade between buyers and sellers free to bargain, which can be
substantiated by data from sources independent of the manufacturer or Contractor; and (3) The
Contractor utilizes the same compensation (wage and fringe benefits) plan for all service employees
performing work under the contract as the Contractor uses for equivalent employees servicing the
same equipment of commercial customers.

(b) If a negative certification is made and a Service Contract Act wage determination is not
attached to the solicitation, the Contractor shall notify the Contracting Officer as soon as
possible.

(c) Failure to execute the certification in paragraph (a) of this clause or to contact the
Contracting Officer as required in paragraph (b) of this clause may render the bid or offer
nonresponsive.

K.19. 52.223-4 RECOVERED MATERIAL CERTIFICATION (OCTOBER 1997)

(This certification is applicable in solicitations that are for, or specify the use, of recovered
materials.)

—NOT APPLICABLE—

As required by the Resource Conservation and Recovery Act of 1976 (42 U.S.C. 6962(c)(3)(A)(i)), the
offeror certifies, by signing this offer, that the percentage of recovered materials to be used in
the performance of the contract will be at least the amount required by the applicable contract
specifications.

53

 

K.20 52.225-2 BUY AMERICAN ACT CERTIFICATE (MAY 2002)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this
provision, is a domestic end product as defined in the clause of this solicitation entitled “Buy
American Act—Supplies” and that the offeror has considered components of unknown origin to have
been mined, produced, or manufactured outside the United States. The offeror shall list as foreign
end products those end products manufactured in the United States that do not qualify as domestic
end products.

(b) Foreign End Products:

          Line Item No.:                                                                                 

          Country of Origin:                                                                                

          (List as necessary)

(c) The Government will evaluate offers in accordance with the policies and procedures of Part 25
of the Federal Acquisition Regulation.

	K.21	 	52.226-2 HISTORICALLY BLACK COLLEGE OR UNIVERSITY AND MINORITY INSTITUTION REPRESENTATION
(MAY 2001)

(a) Definitions. As used in this provision—

Historically Black College or University means an institution determined by the Secretary of
Education to meet the requirements of 34 CFR 608.2. For the Department of Defense, the National
Aeronautics and Space Administration, and the Coast Guard, the term also includes any nonprofit
research institution that was an integral part of such a college or university before November 14,
1986.

Minority Institution means an institution of higher education meeting the requirements of Section
1046(3) of the Higher Education Act of 1965 (20 U.S.C. 1067k, including a Hispanic-serving
institution of higher education, as defined in Section 316(b)(1) of the Act (20 U.S.C. 1101a.)).

(b) Representation. The offeror represents that it—

o is o is not a Historically Black College or University;

o is o is not a Minority Institution.

K.22 52.227-6 ROYALTY INFORMATION (APRIL 1984)

(a) Cost or charges for royalties. When the response to this solicitation contains costs or charges
for royalties totaling more than $250, the following information shall be included in the response
relating to each separate item of royalty or license fee:

          (1) Name and address of licensor.

          (2) Date of license agreement.

          (3) Patent numbers, patent application serial numbers or other basis on which the royalty is payable.

          (4) Brief description, including any part or model numbers of each contract item or component on which the royalty is payable.

          (5) Percentage or dollar rate of royalty per unit.

          (6) Unit price of contract item.

          (7) Number of units.

          (8) Total dollar amount of royalties.

54

 

(b) Copies of current licenses. In addition, if specifically requested by the Contracting Officer
before execution of the contract, the offeror shall furnish a copy of the current license agreement
and an identification of applicable claims of specific patents.

K.23 52.230-1 COST ACCOUNTING STANDARDS NOTICES AND CERTIFICATION (JUNE 2000)

Note: Commercial Items sold at firm-fixed prices – NOT APPLICABLE

Note: This notice does not apply to small businesses or foreign governments. This notice is in
three parts, identified by Roman numerals I through III.

Offerors shall examine each part and provide the requested information in order to determine Cost
Accounting Standards (CAS) requirements applicable to any resultant contract.

If the offeror is an educational institution, Part II does not apply unless the contemplated
contract will be subject to full or modified CAS-coverage pursuant to 48 CFR 9903.201-2(C)(5) or
9903.201-2(c)(6), respectively.

I. Disclosure Statement — Cost Accounting Practices and Certification

(a) Any contract in excess of $500,000 resulting from this solicitation will be subject to the
requirements of the Cost Accounting Standards Board (48 CFR Chapter 99), except for those contracts
which are exempt as specified in 9903.201-1.

(b) Any offeror submitting a proposal which, if accepted, will result in a contract subject to the
requirements of 48 CFR Chapter 99 must, as a condition of contracting, submit a Disclosure
Statement as required by 9903.202. When required, the Disclosure Statement must be submitted as a
part of the offeror’s proposal under this solicitation unless the offeror has already submitted a
Disclosure Statement disclosing the practices used in connection with the pricing of this proposal.
If an applicable Disclosure Statement has already been submitted, the offeror may satisfy the
requirement for submission by providing the information requested in paragraph (c) of Part I of
this provision.

CAUTION: In the absence of specific regulations or agreement, a practice disclosed in a Disclosure
Statement shall not, by virtue of such disclosure, be deemed to be a proper, approved, or agreed-to
practice for pricing proposals or accumulating and reporting contract performance cost data.

(c) Check the appropriate box below:

o (1) Certificate of Concurrent Submission of Disclosure Statement.

The offeror hereby certifies that, as part of the offer, copies of the Disclosure Statement have
been submitted as follows:

(i) original and one copy to the cognizant Administrative Contracting Officer (ACO), or
cognizant Federal agency official authorized to act in that capacity (Federal official), as
applicable, and;

(ii) one copy to the cognizant Federal auditor.

(Disclosure must be on Form No. CASB DS-1 or CASB DS-2, as applicable.. Forms may be obtained from
the cognizant ACO or Federal official and/or from the loose-leaf version of the Federal Acquisition
Regulation).

55

 

Date of Disclosure Statement:                                                            

Name and Address of Cognizant ACO or Federal Official Where Filed:

                                                                                                                        

The offeror further certifies that the practices used in estimating costs in pricing this
proposal are consistent with the cost accounting practices disclosed in the Disclosure
Statement.

o (2) Certificate of Previously Submitted Disclosure Statement. The offeror hereby certifies
that the required Disclosure Statement was filed as follows:

Date of Disclosure Statement:                                                             

Name and Address of Cognizant ACO or Federal Official Where Filed:

                                                                                                                        

The offeror further certifies that the practices used in estimating costs in pricing this proposal
are consistent with the cost accounting practices disclosed in the applicable Disclosure Statement.

o (3) Certificate of Monetary Exemption. The offeror hereby certifies that the offeror together
with all divisions, subsidiaries, and affiliates under common control, did not receive net awards
of negotiated prime contracts and subcontracts subject to CAS totaling more than $50 million or
more in the cost accounting period immediately preceding the period in which this proposal was
submitted. The offeror further certifies that if such status changes before an award resulting from
this proposal, the offeror will advise the Contracting Officer immediately.

o (4) Certificate of Interim Exemption. The offeror hereby certifies that:

(i) the offeror first exceeded the monetary exemption for disclosure, as defined in (3) of this
subsection, in the cost accounting period immediately preceding the period in which this offer was
submitted, and

(ii) in accordance with 48 CFR 9903.202-1, the offeror is not yet required to submit a Disclosure
Statement. The offeror further certifies that if an award resulting from this proposal has not been
made within 90 days after the end of that period, the offeror will immediately submit a revised
certificate to the Contracting Officer, in the form specified under subparagraph (c)(1) or (c)(2)
of Part I of this provision, as appropriate, to verify submission of a completed Disclosure
Statement.

CAUTION: Offerors currently required to disclose because they were awarded a CAS-covered prime
contract or subcontract of $50 million or more in the current cost accounting period may not claim
this exemption (4). Further, the exemption applies only in connection with proposals submitted
before expiration of the 90-day period following the cost accounting period in which the monetary
exemption was exceeded.

o (5) Certificate of Disclosure Statement Due Date by Educational Institution.

(ALTERNATE I — APRIL 1996)

If the offeror is an educational institution that, under the transition provisions of 48 CFR
9903-202-1(f), is or will be required to submit a Disclosure Statement after receipt of this award,
the offeror hereby certifies that (check one and complete):

o (i) A Disclosure Statement filing Due Date of has been established with the cognizant Federal
agency.

56

 

o(ii) The Disclosure Statement will be submitted within the 6-month period ending ___months
after receipt of this award.

Name and Address of Cognizant ACO or Federal Official Where Disclosure Statement is to be Filed:

 

II. Cost Accounting Standards — Eligibility for Modified Contract Coverage

If the offeror is eligible to use the modified provisions of 48 CFR 9903.201-2(b) and elects to do
so, the offeror shall indicate by checking the box below. Checking the box below shall mean that
the resultant contract is subject to the Disclosure and Consistency of Cost Accounting Practices
clause in lieu of the Cost Accounting Standards clause.

o The offeror hereby claims an exemption from the Cost Accounting Standards clause under the
provisions of 48 CFR 9903.201-2(b) and certifies that the offeror is eligible for use of the
Disclosure and Consistency of Cost Accounting Practices clause because during the cost accounting
period immediately preceding the period in which this proposal was submitted, the offeror received
less than $50 million in awards of CAS-covered prime contracts and subcontracts. The offeror
further certifies that if such status changes before an award resulting from this proposal, the
offeror will advise the Contracting Officer immediately.

CAUTION: An offeror may not claim the above eligibility for modified contract coverage if this
proposal is expected to result in the award of a CAS-covered contract of $50 million or more or if,
during its current cost accounting period,

the offeror has been awarded a single CAS-covered prime contract or subcontract of $50 million or
more.

III. Additional Cost Accounting Standards Applicable to Existing Contracts

The offeror shall indicate below whether award of the contemplated contract would, in accordance
with subparagraph (a)(3) of the Cost Accounting Standards Clause, require a change in established
cost accounting practices affecting existing contracts and subcontracts.

o YES           o NO

K.24 CERTIFICATION OF INSTITUTIONAL POLICY ON CONFLICT OF FINANCIAL INTEREST (OCTOBER 1995)

(Note: This certification is applicable to Research and Development (R&D) Contracts. However, this
certification does not apply to SBIR-Phase I contractors.)

By submission of its offer, the offeror certifies that:

(1) A written and enforced administrative process to identify and manage, reduce or eliminate
conflicting financial interest with respect to all research projects for which funding is sought
from the NIH is o, is not o currently in effect.

(2) Should a process not be in effect at the time of the submission of its offer, the offeror
certifies that it will, no later than 30 days subsequent to submission of its offer or prior to
award, whichever is earlier, notify the Contracting Officer of the establishment of a written and
enforced financial conflict of interest policy.

57

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