exv4w18



 


Exhibit 4.18


OMB Approval 2700-0042



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
“[*****]” or “*****”. 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.




	 	 	 	 	 	 	 	 	 	 	 	 	 
	

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

	 	RATING
	 	PAGE

1
	 	OF
	 	PAGES

38
	

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

200-2002-00004

	 	3. EFFECTIVE DATE

November 28, 2001

	 	4. REQUISITION/PURCHASE REQUEST/PROJECT NO.	 
	

	5.	 	
ISSUED BY
	 	CODE
	6. ADMINISTERED BY (If other than Item 6)
	CODE
	 	 	 	7523
	 	 	
Centers for Disease Control and
Prevention (PGO)

2920 Brandywine Rd., Room 3000

Atlanta, GA 30341-5539	 	 	 	 	 	 	 	 	 	 
	

	7.	 	NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code)	 	8. DELIVERY	 	 	 	 	 	 
	 	 	
Acambis Inc.
	 	 	 	   o FOB ORIGIN   X OTHER (See below)	 	 	 	 	 	 
	 	 	
38 Sidney Street

	 	 	 	9. DISCOUNT FOR PROMPT PAYMENT
	 	 	 	 	 	 
	 	 	
Cambridge, MA 02139

	 	 	 	   Net 30	 	 	 	 	 	 
	 	 	
TIN: ******
	 	 	 	10. SUBMIT INVOICES

(4 copies unless other-

wise specified) TO
THE     4

ADDRESS SHOWN IN:
	 	ITEM

See G.1	 	 	 	 
	

	 	 	
CODE      6511
	 	FACILITY CODE	 	 	 	 	 	 	 	 
	





	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	11.	 	
SHIP TO/MARK FOR
	 	CODE
	 	 	12.	 	 	PAYMENT WILL BE MADE BY
	 	CODE
	 	 	7523	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	
As Specified in Individual Delivery Orders
	 	 	 	 	 	 	 	Centers for Disease Control and Prevention (FMO)

P.O Box 15580

Atlanta, GA 30333	 	 	 	 	 	 
	

	13.	 	
AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:
	 	14.	 	 	ACCOUNTING AND APPROPRIATION DATA	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	Appropriation: 7520140      Allowance: 2-A2646	 	 	 	 	 	 
	 	 	
o 10 U.S.C. 2304(c)(     )      o 41 U.S.C. 253(c)(     )
	 	 	 	 	 	 	 	OCC: 25.55      CAN: 0921-1032      Amt: $3,000,000.00	 	 	 	 	 	 
	





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

	 	 	 	 	 	 	 	 	 	 	 
	 	 	
Smallpox Vaccine- Development Thru Licensure
	 	 	 	 	 	 	 	See Sec. B
	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	ESTIMATED
	

	 	 	15G.
TOTAL AMOUNT OF CONTRACT   4 	 	$432,152,000 est
	





	 	 	 	 	 	 	 
	16. TABLE OF CONTENTS
	

	(ü)	 	SEC.	 	DESCRIPTION	 	PAGE(S)
	

PART I — THE SCHEDULE

	

	X	 	
A
	 	SOLICITATION/CONTRACT FORM
	 	1
	

	X	 	
B
	 	SUPPLIES OR SERVICES AND PRICE/COST
	 	2-5
	

	X	 	
C
	 	DESCRIPTION/SPECS./WORK STATEMENT
	 	6-11
	

	X	 	
D
	 	PACKAGING AND MARKING
	 	12
	

	X	 	
E
	 	INSPECTION AND ACCEPTANCE
	 	13
	

	X	 	
F
	 	DELIVERIES OR PERFORMANCE
	 	14-16
	

	X	 	
G
	 	CONTRACT ADMINISTRATION DATA
	 	17-20
	

	X	 	
H
	 	SPECIAL CONTRACT REQUIREMENTS
	 	21-31
	

	 	 	 	 	PART II — CONTRACT CLAUSES	 	 
	

	X	 	
I
	 	CONTRACT CLAUSES
	 	32-37
	

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

	X	 	
J
	 	LIST OF ATTACHMENTS
	 	38
	

	 	 	 	 	PART IV — REPRESENTATIONS AND INSTRUCTIONS	 	 
	

	X	 	
K
	 	REPRESENTATIONS, CERTIFICATIONS

AND OTHER STATEMENTS OF OFFERORS
	 	By Ref
	

	 	 	
L
	 	INSTRS., CONDS., AND NOTICES TO OFFERORS	 	 
	

	 	 	
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      3     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
including obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this
on any award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and
offer, specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)	 	
18. o AWARD (Contractor is not required to sign this document.) Your offer on Solicitation Number      ,
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
continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your
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	 	 	 	 
	 	 	
Gordon Cameron	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	
President & CFO
	 	 	 	 	 	 	 	Lorenzo J. Falgiano	 	 	 	 
	

	19B	 	
NAME OF CONTRACTOR
	 	19C
	 	DATE SIGNED
	 	20B
	 	UNITED STATES OF AMERICA
	 	20C
	 	DATE SIGNED
	 	 	 	 	 	 	 	 	BY	 	 	 	 	 	 
	 	 	


	 	 	 	 	 	 	 	
	 	 	 	 
	 	 	
(Signature of person authorized to sign)
	 	 	 	11/28/01
	 	 	 	(Signature of Contracting Officer)
	 	 	 	11/28/01
	





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















 


Section B — Supplies Or Services And Prices/Costs





	B.1	 	352.232-74 CONSIDERATION – FIRM-FIXED-PRICE – INCREMENTALLY FUNDED LINE ITEM




	 	 	 	 	 	 	 	 	 
	LINE	 	SUPPLIES/SERVICES	 	ESTIMATED	 	UNIT	 	EXTENDED
	ITEM	 	 	 	QUANTITY/	 	PRICE/	 	PRICE
	 	 	 	 	UNIT	 	MONTH	 	 
	0001	 	
Development,
Production and
FDA Licensure of
Smallpox vaccine
	 	******
	 	******
	 	******





	 	 	Guaranteed Minimum: $3,000,000.00





	 	(a)	 	It is determined that the total price to the Government for
full performance of this line item will be ******
	 
	 	(b)	 	Total funds currently available for payment and allotted to
this line item are ****** For further provisions on funding, see
Limitation of Funds clause.
	 
	 	(c)	 	It is estimated that the amount currently allotted will cover
****** which is scheduled to be completed by ******.
	 
	 	(d)	 	The Contracting Officer may allot additional funds to the
contract without the concurrence of the Contractor.
	 
	 	(e)	 	Monthly payments will be made upon submission of a properly
executed invoice and submission of the Monthly Progress Reports
required per Section C.8.



3







 





	B.2	 	FIRM-FIXED-PRICE (Indefinite quantity/Indefinite delivery)
	 
	 	 	The following doses shall be delivered to the stockpile for use under an IND.




	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Estimated	 	 	 	 
	Line item	 	Supplies/Services	 	quantity/unit	 	Unit price	 	Extended price
	 	 	 	 	(millions)	 	($)	 	($ million)*
	0002	 	
Smallpox Vaccine
	 	50 – 50
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	51 –  55
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	56 –  60
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	61 –  65
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	66 –  70
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	71 –  75
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	76 –  80
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	81 –  85
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	86 –  90
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	91 –  95
	 	doses
	 	******
	 	******
	0003	 	
Smallpox Vaccine
	 	96 – 100
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	101 –  105
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	106 –  110
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	111 –  115
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	116 –  120
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	121 –  125
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	126 –  130
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	131 –  135
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	136 –  140
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	141 –  145
	 	doses
	 	******
	 	******
	0004	 	
Smallpox Vaccine
	 	146 – 150
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	151 –  155
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	156 –  160
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	161 –  165
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	166 –  170
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	171 –  175
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	176 –  180
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	181 –  185
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	186 –  190
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	191 –  195
	 	doses
	 	******
	 	******
	0005	 	
Smallpox Vaccine
	 	196 – 200
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	201 –  205
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	206 –  210
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	211 –  215
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	216 –  220
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	221 –  225
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	226 –  230
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	231 –  235
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	236 –  240
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	241 –  245
	 	doses
	 	******
	 	******
	0006	 	
Smallpox Vaccine
	 	246 – 250
	 	doses
	 	******
	 	******



* Computed based upon highest estimated quantity for each Line Item

Estimated Minimum Quantity: 50M Doses

Estimated Maximum Quantity: 250M Doses


4







 




	B.3	 	FIRM-FIXED-PRICE
	 
	 	 	The prices below include the cost associated with finalizing the vaccines
delivered under line items 0002-0006 as FDA licensed vaccines.




	 	 	 	 	 	 	 	 	 
	LINE	 	SUPPLIES/SERVICES	 	ESTIMATED	 	UNIT	 	EXTENDED
	ITEM	 	 	 	QUANTITY/	 	PRICE	 	PRICE *
	 	 	 	 	UNIT	 	 	 	 
	0007	 	
Smallpox Vaccine
	 	50M Doses
	 	******
	 	******
	0008	 	
Smallpox Vaccine
	 	51M-100M Doses
	 	******
	 	******
	0009	 	
Smallpox Vaccine
	 	101M-150M Doses
	 	******
	 	******
	0010	 	
Smallpox Vaccine
	 	151M-200M Doses
	 	******
	 	******
	0011	 	
Smallpox Vaccine
	 	201M-250M Doses
	 	******
	 	******



* Computed based upon highest estimated quantity for each Line Item

Estimated Minimum Quantity: 50M Doses

Estimated Maximum Quantity: 250M Doses




	B.4	 	FIRM-FIXED-PRICE




	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES/SERVICES	 	ESTIMATED	 	UNIT	 	EXTENDED
	 	 	 	 	QUANTITY/	 	PRICE/	 	PRICE *
	 	 	 	 	UNIT	 	MONTH/	 	 
	 	 	 	 	 	 	DOSE	 	 
	0012	 	
Program Management
	 	50M Doses
	 	******
	 	******
	 	 	
******
	 	51M-100M Doses
	 	******
	 	******
	 	 	
******
	 	101M-150M Doses
	 	******
	 	******
	 	 	
******
	 	151M-200M Doses
	 	******
	 	******
	 	 	
******
	 	201M-250M Doses
	 	******
	 	******





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



 







 



OPTION ITEMS





	B.5	 	FIRM-FIXED-PRICE (Indefinite Quantity/Indefinite Delivery)




	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Estimated	 	 	 	 
	Line item	 	Supplies/Services	 	quantity/unit	 	Unit price	 	Extended price
	 	 	 	 	(millions)	 	($)	 	($ million)*
	00013	 	
Smallpox Vaccine
	 	50 –  50
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	51 –  55
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	56 –  60
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	61 –  65
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	66 –  70
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	71 –  75
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	76 –  80
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	81 –  85
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	86 –  90
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	91 –  95
	 	doses
	 	******
	 	******
	00014	 	
Smallpox Vaccine
	 	96 –  100
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	101 –  105
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	106 –  110
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	111 –  115
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	116 –  120
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	121 –  125
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	126 –  130
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	131 –  135
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	136 –  140
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	141 –  145
	 	doses
	 	******
	 	******
	00015	 	
Smallpox Vaccine
	 	146 –  150
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	151 –  155
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	156 –  160
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	161 –  165
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	166 –  170
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	171 –  175
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	176 –  180
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	181 –  185
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	186 –  190
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	191 –  195
	 	doses
	 	******
	 	******
	00016	 	
Smallpox Vaccine
	 	196 –  200
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	201 –  205
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	206 –  210
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	211 –  215
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	216 –  220
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	221 –  225
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	226 –  230
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	231 –  235
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	236 –  240
	 	doses
	 	******
	 	******
	 	 	
Smallpox Vaccine
	 	241 –  245
	 	doses
	 	******
	 	******
	00017	 	
Smallpox Vaccine
	 	246 –  250
	 	doses
	 	******
	 	******



* Computed based upon highest estimated quantity for each Line Item

Estimated Minimum Quantity: 50M Doses

Estimated Maximum Quantity: 250M Doses



Section C –  Description/Specification/Work Statement



 







 


The Contractor shall provide the necessary services and supplies as described
in the Statement of Work below:





	C.1	 	BACKGROUND
	 
	 	 	The United States Government has recognized the need to maintain a
stockpile of a smallpox vaccine to deal with the consequences if smallpox
virus were used as a terrorist weapon against the civilian population.
The Department of Health and Human Services (DHHS), Centers for Disease
Control and Prevention (CDC), National Center for Infectious Diseases
(NCID), has been charged with the responsibility to award a contract to
******. This contract contemplates the development, licensing, and
production of a new product.
	 
	C.2	 	PURPOSE
	 
	 	 	The purpose of this contract is to provide a stockpile of smallpox
vaccines in the shortest timeframe possible to be used in case of a public
health emergency and maintain current Good Manufacturing Practices (cGMP)
capacity for the production of the smallpox vaccine for the life of the
contract.
	 
	C.3	 	SCOPE OF WORK
	 
	 	 	The Contractor, as an independent organization and not as an agent of the
Government, shall furnish all labor, materials, supplies, facilities,
equipment, transportation and travel required to develop a candidate
smallpox vaccine, produce compliant pilot lots for testing vaccines,
conduct clinical trials, obtain final FDA licensure, produce a minimum of
50 million doses of the vaccine to include bifurcated needles and diluent
as appropriate for administration of the vaccines, ****** in case of an
emergency.
	 
	C.4	 	SPECIFIC TECHNICAL REQUIREMENTS





	 	1.	 	Development and Licensure of a Smallpox Vaccine





	 	a.	 	The Contractor shall develop a new smallpox vaccine
that meets the following specifications:
	 
	 	 	 	******
	 
	 	 	 	******
	 
	 	 	 	******



 







 




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





	 	 	 	******





	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******



 







 




	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	2.	 	Full Scale Production (Delivery of Vaccines to Stockpile)




 







 

	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	 	******





	 	 	******





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





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





	 	 	 	******





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



 







 




	 	4.	 	Security
	 
	 	 	 	The contractor shall develop and implement a security plan for the
manufacture ****** of vaccine acceptable to the Government.





	C.5	 	EMERGENCY CONTACTS
	 
	 	 	The Contractor shall provide a point of contact that will be available 24
hours per day, seven days per week to be contacted in case of a public
health emergency.



******





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



******





	 	 	******
	 
	 	 	******
	 
	 	 	******
	 
	 	 	******
	 
	C.8	 	REPORTING REQUIREMENTS
	 
	 	 	The Contractor shall submit real time and a Monthly Progress Report. The
Monthly Progress Report shall include the information listed below that is
applicable for the performance period during the month being reported.
The Contractor shall submit one copy of the Monthly Progress Report
electronically via e-mail. Any attachments to the e-mail report shall be
submitted in Microsoft Word or WordPerfect 9 or compatible version.





	 	1.	 	Procurement of the vaccinia strains;
	 
	 	2.	 	Quality control testing of acquired virus (genomic
integrity) and purity;



 







 




	 	3.	 	Development of cell culture substrate;
	 
	 	4.	 	Pilot lots plaque assay results;
	 
	 	5.	 	FDA inspections and consultation results or recommendation;
	 
	 	6.	 	****** stability studies for expiration date results (real time
and accelerated);
	 
	 	7.	 	Security assessment, problems and recommendations;
	 
	 	8.	 	Clinical trial study results;
	 
	 	9.	 	Scale up to full production capacity assessment problems and
recommendations, to include raw material procurement status;
	 
	 	10.	 	Quality Control Potency assessment;
	 
	 	11.	 	******
	 
	 	12.	 	******
	 
	 	13.	 	******
	 
	 	14.	 	Overall project assessment, problems encountered and
recommended solutions, etc.



 







 



Section D –  Packaging and Marking





	D.1	 	PACKAGING AND MARKING REQUIREMENTS





	 	(a)	 	Packaging shall be standard commercial to accommodate
refrigerated and/or frozen items to ensure acceptance by common
carrier for safe delivery to destination.
	 
	 	(b)	 	All shipping mailing containers
shall be marked ******.



 







 



Section E –  Inspection and Acceptance




	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.246-16	 	
Responsibility for Supplies (Apr 1984)
	52.246-2	 	
Inspection of Supplies– Fixed-Price (Aug 1996)
	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
Contracting Officer, or his duly authorized representative (who
for the purposes of this contract shall be the Project Officer)
at the destination of the articles, services or documentation.
	 
	 	(b)	 	The Government 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, as a minimum will include Device Master Records, document control
procedures, facilities, personnel training records, equipment process
procedures, and Quality Assurance Program reviews. Further, the on site
representative(s), if designated, will perform the inspection and acceptance of
articles, services and documentation contained in (a) above.



 







 






Section F –  Deliveries or Performance




	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.242-15	 	
Stop Work Order (Aug 1989)
	52.242-17	 	
Government Delay of Work (Apr 1984)
	52.247-34	 	
F.O.B. Destination (Nov 1991)





	F.1	 	DELIVERABLE(S) SCHEDULE





	 	(a)	 	The Contractor shall deliver, within the timeframes
specified, all items listed below to the Contracting Officer at the
address shown on the face page of the contract. The Contractor
shall deliver Item Numbers 1, 2, 3, 4, 5, 8 and 9 to the Project
Officer at the following address:
	 
	 	 	 	Centers for Disease Control and Prevention

Attn: Project Officer

1600 Clifton Road, Mail Stop D09

Atlanta, GA. 30333




	 	 	 	 	 	 	 	 	 
	Item No.	 	Description	 	No. of	 	Delivery Date
	 	 	 	 	Copies	 	 
	1	 	
Monthly Progress Report
	 	 	1	 	 	By the 10th of each
Month following the
end of the month
being reported
	2	 	
Proof of Filing
Application with FDA to
perform Clinical Trials
(if applicable)
	 	 	1	 	 	Within 45 Calendar
Days following
pilot lot
production that
included all
quality control and
release testing
required for use in
clinical trials
	3	 	
Proof of Filing
Application with FDA for
Licensure of Vaccines
	 	 	1	 	 	Within 7 Calendar

Days after filing

the application

with FDA




	 	 	 	 	 	 	 	 	 
	Item No.	 	Description	 	No. of	 	Delivery Date
	 	 	 	 	Copies	 	 
	4	 	
Draft Security Plan
	 	 	2	 	 	30 Calendar Days
After Award of the
Contract
	5	 	
Final Security Plan
	 	 	2	 	 	10 Calendar Days
After Receipt of
the Government’s
Comments



 







 



	 	 	 	 	 	 	 	 	 
	Item No.	 	Description	 	No. of	 	Delivery Date
	 	 	 	 	Copies	 	 
	6	 	
Confidentiality Agreements
	 	 	1	 	 	Prior to
Performance of Work
Under the Contract
	7	 	
Evidence of Registration
with the Secretary of
Agriculture of the United
States – Care of Live
Vertebrate Animals
	 	 	1	 	 	Prior to
Undertaking
Performance of
Tasks Involving
Live Vertebrate
Animals
	8	 	
Contractor IRB Approval
	 	 	1	 	 	Prior to Expending
Funds for Research
Involving Human
Subjects
	9	 	
Annual IRB Certification
	 	 	 	 	 	Prior to the
Expiration of
Current Approval
	10	 	
Assurance of Compliance
on File with the Office
Human Research Protection
(OHRP)
	 	 	1	 	 	Prior to
Undertaking
Performance of
Tasks Involving
Human Subjects





	 	(b)	 	The Contractor shall deliver the following items to the
consignee specified in each delivery order or shipping order within
the timeframe specified below:




	 	 	 	 	 	 	 
	Item No.	 	Description	 	Quantity	 	Delivery
	 	 	 	 	 	 	Date
	1	 	
Vaccine Products for
Stockpile to be used
Under an IND in an
Emergency Situation
	 	As Specified
In Section B.2
	 	12/31/02
	2	 	
Finalization of Vaccines
Delivered for Use Under
IND as FDA Licensed
Vaccines
	 	As specified
In Section B.3
	 	To be determined
At the time the
Modification is
Issued to Fund
The Line Item
	3	 	
******
	 	******
	 	******





	 	(c)	 	The Contractor shall deliver the following items to the
Government to the locations specified by the Government within the
timeframe specified below:





	 	 	 	 	 	 	 
	Item No.	 	Description	 	Quantity	 	Delivery Date









 




	 	 	 	 	 	 	 
	1	 	
******
	 	******
	 	******





	F.2	 	PERIOD OF PERFORMANCE
	 
	 	 	The period of performance for the basic contract will be for 60 months
from date of award. The period of performance for delivery orders will be
negotiated with the Contractor prior to award of the delivery order. The
actual period of performance for delivery orders may extend beyond the
contract period.





 









 




Section G — Contract Administration Data



     G.1 EVALUATION OF CONTRACTOR’S PERFORMANCE (SERVICES)





	 	(a)	 	Purpose
	 
	 	 	 	In accordance with FAR 42.1502, the Contractor’s performance will
be periodically evaluated by the Government, in order to provide
current information for source selection purposes. These
evaluations will therefore be marked “Source Selection
Information.”
	 
	 	(b)	 	Performance Evaluation Period
	 
	 	 	 	The Contractor’s performance will be evaluated at least annually.
	 
	 	(c)	 	Evaluators
	 
	 	 	 	The performance evaluation will be completed jointly by the Project
officer and the Contracting officer.
	 
	 	(d)	 	Performance Evaluation Factors
	 
	 	 	 	The contractor’s performance will be evaluated in accordance with
the attachment listed in Section J titled Performance Evaluation
Report.
	 
	 	(e)	 	Contractor Review
	 
	 	 	 	A copy of the evaluation will be provided to the contractor within
ten working days after completion of the evaluation. The
contractor shall submit comments, rebutting statements, or
additional information to the Contracting Officer within 30
calendar days after receipt of the evaluation.
	 
	 	(f)	 	Resolving Disagreements Between the Government and the Contractor
	 
	 	 	 	Disagreements between the parties regarding the evaluation will be
reviewed at a level above the Contracting Officer. The ultimate
conclusion on the performance evaluation is a decision of the
contracting agency. Copies of the evaluation, contractor’s
response, and review comments, if any, will be retained as part of
the evaluation.
	 
	 	(g)	 	Release of Contractor Performance Evaluation Information
	 
	 	 	 	The completed evaluation will not be released to other than
Government personnel and the contractor whose performance is being
evaluated. Disclosure of such information could cause harm both to
the commercial interest of the Government and to the competitive
position of the contractor being evaluated as well as impede the
efficiency of Government operations.
	 
	 	(h)	 	Source Selection Information
	 
	 	 	 	Departments and agencies may share past performance information
with other Government departments and agencies when requested to
support future award decisions. The information may be provided



 







 





	 	 	 	through interview and/or by sending the evaluation and comment
document to the requesting source selection official.
	 
	 	(i)	 	Retention Period
	 
	 	 	 	The agency will retain past performance information for a maximum
period of three years after completion of contract performance for
the purpose of providing source selection information for future
contract awards.




G.2 PAYMENTS BY ELECTRONIC FUNDS TRANSFER





	 	(a)	 	The Government shall use electronic funds transfer to the maximum
extent possible when making payments under this contract. FAR
52.232-34, Payment by Electronic Funds Transfer–Other than Central
Contractor Registration, incorporated by reference in Section I,
requires the contractor to designate in writing a financial
institution for receipt of electronic funds transfer payments.
	 
	 	(b)	 	The contractor shall make the designation by submitting the
form titled “ACH Vendor/Miscellaneous Payment Enrollment Form” to
the address indicated below. Note: The form is either attached to
this contract (see Section J, List of Attachments) or may be
obtained by contacting the Contracting Officer or the CDC Financial
Management Office at (404) 687-6666.
	 
	 	(c)	 	In cases where the contractor has previously provided such
designation, i.e., pursuant to a prior contract/order, and been
enrolled in the program, the form is not required.
	 
	 	(d)	 	The completed form shall be mailed after award, but no later
than 14 calendar days before an invoice is submitted, to the
following address:





	 	 	 	Centers for Disease Control & Prevention (CDC)

Financial Management Office

Post Office Box 15580

Atlanta, GA 30333




G.3 INVOICE SUBMISSION





	 	(a)	 	Invoices





	 	(1)	 	The Contractor shall submit an original and three
(3) copies of contract invoices to the Contracting Officer at
the address shown on the face page of the contract.
	 
	 	(2)	 	The Contractor agrees to include (as a minimum)
the following information on each invoice:





	 	i.	 	Contractor’s Name & Address;
	 
	 	ii.	 	Contractor’s Tax Identification Number (TIN);
	 
	 	iii.	 	Contract Number;
	 
	 	iv.	 	Invoice Number;
	 
	 	v.	 	Invoice Date;
	 
	 	vi.	 	Contract Line Item Number (per Section B);
	 
	 	
vii.	 	 Quantity;



 







 



	 	viii.	 	Unit Price & Extended Amount for each line item;
ix. Total Amount of Invoice; and
	 



	 	ix.	 	Total Amount of Invoice; and
	 




	 	x.	 	Name, title and telephone number of
person to be notified in the event of a defective
invoice.




G.4 PROJECT OFFICER





	 	(a)	 	Performance of the work hereunder shall be subject to the
technical directions of the designated Project Officer for this
contract.
	 
	 	(b)	 	As used herein, technical directions are directions to the
Contractor which fill in details, suggests possible lines of
inquiry, or otherwise completes the general scope of work set forth
herein. These technical directions must be within the general scope
of work, and may not alter the scope of work or cause changes of
such a nature as to justify an adjustment in the stated contract
price/cost or period of performance, or any stated limitation
thereof. In the event that the Contractor feels that full
implementation of any of these directions may exceed the scope of
the contract, he or she shall notify the originator of the technical
direction and the Contracting Officer in a letter separate of any
required report(s) within two (2) weeks of the date of receipt of
the technical direction and no action shall be taken pursuant to the
direction. If the Contractor fails to provide the required
notification within the said two (2) week period that any technical
direction exceeds the scope of the contract, then it shall be deemed
for purposes of this contract that the technical direction was
within the scope. No technical direction, nor its fulfillment,
shall alter or abrogate the rights and obligations fixed in this
contract.
	 
	 	(c)	 	The Government Project Officer is not authorized to change
any of the terms and conditions of this contract. Changes shall be
made only by the Contracting Officer by properly written
modification(s) to the contract.
	 
	 	(d)	 	The Government will provide the Contractor with a copy of the
delegation memorandum for the Project Officer. Any changes in
Project Officer delegation will be made by the Contracting Officer
in writing with a copy being furnished to the Contractor.




G.5 CONTRACTING OFFICER





	 	(a)	 	The Contracting Officer is the only individual who can legally
commit the Government to the expenditure of public funds. No person
other than the Contracting Officer can make any changes to the
terms, conditions, general provisions, or other stipulations of
this contract.
	 
	 	(b)	 	No information, other than that which may be contained in an
authorized modification to this contract, duly issued by the
Contracting Officer, which may be received from any person employed
by the United States Government, or otherwise, shall be considered
grounds for deviation from any stipulation of this contract.



 







 



G.6 CONTRACT COMMUNICATIONS/CORRESPONDENCE





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




G.7 PRIVACY ACT MONITOR





	 	 	 	The Project Officer is hereby designated as the Privacy Act Monitor for
this contract.



 







 



Section H — Special Contract Requirements




H.1 KEY PERSONNEL





	 	 	 	The key personnel cited below are considered essential to the work being
performed under the contract. If these individuals leave the Contractor’s
or Subcontractor’s employ or are reassigned to other programs, the
Contractor shall notify the Contracting Officer reasonably in advance and
shall submit justification (including proposed substitutions) in
sufficient detail to permit evaluation of the impact on the program. No
diversion or replacement shall be made by the Contractor without the
written consent of the Contracting Officer.




	 	 	 
	Personnel	 	
Title
	 	 	 
	*******	 	
*******
	*******	 	
*******
	*******	 	
*******




H.2 KEY SUBCONTRACTS



     The subcontractor cited below was evaluated by the Government in the
source selection process and is considered key to both the award and successful
performance of the contract. If the contractor is unable to execute a
subcontract with this firm that is acceptable to both parties, the contractor
shall notify the Contracting Officer reasonably in advance and shall submit
justification (including proposed substitutions) in sufficient detail to permit
evaluation of the impact on the program. No diversion of work or replacement
of the below listed subcontractor shall be made by the Contractor without the
written consent of the Contracting Officer.




	 	 	 
	Subcontractor	 	
Scope of Subcontract
	 	 	 
	Baxter Healthcare	 	
Manufacture crude bulk vaccine;

*******, shipment, and kit

Preparation




H.3 PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES





	 	 	 	The contractor is hereby notified of the restrictions on the use of
Department of Health and Human Service’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 Department of Health and Human Services
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 Department of Health and Human Services 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.4 SMOKE FREE ENVIRONMENT





	 	 	 	In compliance with Department of Health and Human Services (DHHS)
regulations, all contractor personnel performing work within CDC/ATSDR
facilities shall observe the CDC/ATSDR smoke-free working environment
policy at all times. This policy prohibits smoking in all CDC/ATSDR
buildings and in front of buildings which are open to the public. This
policy is also applicable to contractor personnel who do not work
full-time within CDC/ATSDR facilities, but are attending meetings within
CDC/ATSDR facilities.




H.5 REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS





	 	 	 	The Representations, Certifications and Other Statements of Offerors
submitted by Acambis, Inc. dated November 2, 2001 are hereby incorporated
by reference, with the same force and effect as if they were given in
full text.




H.6 DATA SUBJECT TO CONFIDENTIALITY REQUIREMENTS





	 	 	 	The type(s) of data subject to the clause at 352.224-70, Confidentiality
of Information, which has been incorporated by reference in Section I,
are as follows:






	 	 	 	Personal Identifiers





	 	 	 	Following are the requirements for handling these data:
	 
	 	 	 	See Contractor’s Security Plan submitted as deliverable under the
contract.



H.7 SAFEGUARDS FOR INDIVIDUALS AND ESTABLISHMENTS AGAINST INVASION OF PRIVACY





	 	 	 	In accordance with Section 308(d) of the Public Health Service Act (42
U.S.C. 242m), the Contractor is required to give an assurance of
confidentiality and to provide safeguards to ensure that 



 







 





	 	 	 	confidentiality
is maintained. To provide this assurance and these safeguards the
Contractor shall:






	 	(a)	 	Be bound by the following assurance:





	 	 	 	Assurance of Confidentiality





	 	 	 	In accordance with Section 308(d) of the Public Health Service Act
(42 U.S.C. 242m), the Director, CDC, assures each respondent that
the confidentiality of responses to this information request will
be maintained by the Contractor and CDC and that no information
obtained in the course of this activity may be disclosed in a
manner in which the particular establishment or individual
supplying the information or described in it is identifiable,
unless such establishment or individual has consented to such
disclosure, to anyone other than authorized staff of CDC.
	 
	 	(b)	 	Maintain the following safeguards to ensure that this
confidentiality is protected by the Contractor’s employees and to
provide for the physical security of the records:





	 	(i)	 	After having read the above assurance of
confidentiality, each employee of the Contractor participating
in this project must sign the following statement of
understanding:
	 
	 	 	 	I have carefully read and I understand the CDC assurance that
pertain to the confidential nature of all records to be
handled in regard to this survey. As an employee of the
Contractor I understand that I am prohibited by law from
disclosing any confidential information obtained under the
terms of this contract to anyone other than authorized staff
of CDC.





	 	 	 	Signature

Date





	 	(ii)	 	To preclude observation of confidential
information by persons not employed on the project, the
Contractor shall maintain under lock and key all confidential
records that identify establishments or individuals or from
which establishments or individuals could be identified.
Specifically, at each site where these items are processed or
maintained, all confidential records that will permit
identification of establishments or individuals are to be
kept in locked containers when not in use by the Contractor’s
employees. The keys or other means of access to these
containers are to be held by a limited number of the
Contractor’s staff at each site. When confidential records
are being used in a room, admittance to the room is to be
restricted to employees pledged to confidentiality and
employed on this project. If at any time the Contractor’s
employees are absent from the room, it is to be locked.
	 
	 	(iii)	 	The Contractor and the Contractor’s professional
staff will take steps to ensure that the intent of the
statement of understanding is enforced at all times through
appropriate qualifications standards for all personnel working
on this 



 







 





	 	 	 	project and through adequate training and periodic
follow up procedures.





	 	(c)	 	Print on the questionnaire in a clearly visible location and
in clearly visible letters in the following notice of the
confidential treatment to be accorded the information on the
questionnaire by any individual who may see it:





	 	 	 	Confidential Information






	 	 	 	Information contained on this form which would permit
identification of any individual or establishment has been
collected with a guarantee that it will be held in strict
confidence by the Contractor and CDC, will be used only for
purposes stated in this study, and will not be disclosed or
released to anyone other than authorized staff of CDC without the
consent of the individual or establishment in accordance with
Section 308(d) of the Public Health Service Act (42 U.S.C. 242m).
	 
	 	(d)	 	In a letter or other form that can be retained by the
individual or the establishment, or on the questionnaire form itself
if it is a self-administered questionnaire, inform in clear and
simple terms each individual or establishment asked to supply
information:





	 	(i)	 	That the collection of the information by CDC and
its Contractor is authorized by Section 306 of the Public
Health Service Act (42 U.S.C. 242k);
	 
	 	(ii)	 	Of the purpose or purposes for which the
information is intended to be used, any plans for disclosures
of information in a form that would permit the identification
of an establishment or individual, and a statement that the
data will be used solely for epidemiological or statistical
research and reporting purposes;
	 
	 	(iii)	 	That participation is voluntary and there are no
penalties for declining to participate in whole or in part;
and
	 
	 	(iv)	 	That no information collected under the authority
of Section 306 of the Public Health Service Act (42 U.S.C.
242k) may be used for any purpose other than the purpose for
which it was supplied, and that information may not be
published or released in other form to anyone other than
authorized staff of CDC if the particular establishment or
individual supplying the information or described in it is
identifiable, unless the establishment or individual has
consented to such release.





	 	(e)	 	Release no information from the data obtained or used under
this contract to any person except authorized staff of CDC.
	 
	 	(f)	 	By a specified date, which may be no later than the date of
completion of the contract, return all study data to CDC or destroy
all such data, as specified by the contract.



 







 



H.8 PRIVACY ACT APPLICABILITY





	 	 	 	Notification is hereby given that the Contractor and its employees are
subject to criminal penalties for violation of the Privacy Act to the
same extent as employees of the Government. The Contractor shall assure
that each of its employees knows the prescribed rules of conduct and that
each is aware that he or she can be subjected to criminal penalty for
violation of the Act. A copy of 09-20-0136, Epidemiologic Studies and
Surveillance of Disease Problems has been attached for your convenience
(see Attachment G). A copy of 45 CFR Part 5b, Privacy Act Regulations,
will be provided by the Government under separate cover if requested by
the Contractor.




H.9 LABORATORY LICENSE REQUIREMENTS





	 	 	 	The Contractor shall comply with all applicable FDA requirements,
requirements of Section 353 of the Public Health Service Act (Clinical
Laboratory Improvement Act as amended) and the Current Good Manufacturing
Practice Regulations (cGMP). This requirement shall also be included in
any subcontract for services under the contract.




H.10 MANUFACTURING STANDARDS





	 	(a)	 	The Current Good Manufacturing Practice Regulations (cGMP)
(21 CFR Parts 210-211) will be the standard to be applied for
manufacturing, processing and packing of this vaccine.
	 
	 	(b)	 	If at any time during the life of the contract, the
Contractor fails to comply with cGMP in the manufacturing,
processing and packaging of this 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 Food and Drug
Administration, the Contractor shall have thirty (30) calendar days
from the time such material failure is identified to cure such
material failure. If the Contractor fails to take such an action
within the thirty (30) calendar day period, then the contract may be
terminated.




H.11 FORCE MAJEURE





	 	 	 	This contract seeks the development, ******* and availability of a
smallpox vaccine to the Government in the event of a national
bioterrorism emergency. The Contractor *******. The Contractor will not
be responsible for damages to ******* if due to force majeure and without
the fault or negligence of the Contractor. For purposes of this
agreement, force majeure shall include the causes of excusable delay set
forth in FAR 52.249-14 except in so far as subsection (a)(5) of such
clause includes smallpox epidemics.



 







 



H.12 TITLE TO VACCINES – CONTRACTOR’S STOCKPILE





	 	 	 	Title of the vaccines will be transferred to the Government upon payment
for the vaccines by the Government. Payment will be made upon acceptance
of the vaccines by the Government and upon receipt of a proper invoice by
the office specified under Section G.3. (This contract contains no
provisions for deductions as cited in FAR 52.232-1, Payments for the line
items in Section B.)




H.13 INDEMNIFICATION





	 	 	 	The vaccine ******* request for indemnification under Public Law 85-804.




H.14 DISSEMINATION OF INFORMATION





	 	 	 	Information related to this contract or to data obtained or generated
under this contract may be released or publicized only after coordination
with the Contracting Officer and the Contractor, provided, however, that
the Contractor may, notwithstanding anything in this clause or clause
HHSAR 352.224-70 to the contrary, disclose such information (i) to
regulatory authorities as may be required to obtain all product marketing
authorizations and pricing approvals in connection with the exercise by
Contractor of its rights under Section H.26 and (ii) to such third
parties, under appropriate confidentiality restrictions, as may be
necessary or useful in connection with the research, development,
registration, manufacturing, ******* and marketing of smallpox vaccine
hereunder. The restrictions set forth above shall not prohibit the
Government from making disclosures required by law, provided that the
Government shall take all actions available under the circumstances to
protect such information.




H.15 352.280-1(b) PROTECTION OF HUMAN SUBJECTS (Oct 1986)





	 	(a)	 	The Contractor agrees that the rights and welfare of human
subjects involved in research under this contract shall be protected
in accordance with 45 CFR Part 46 and with the Contractor’s current
Assurance of Compliance on file with the Office for Human Research
Protection (OHRP). The Contractor further agrees to provide
certification at least annually that the institutional review board
has reviewed and approved the procedures which involve human
subjects in accordance with 45 CFR Part 46 and the Assurance of
Compliance.
	 
	 	(b)	 	The Contractor shall bear full responsibility for the
performance of all work and services involving the use of human
subjects under this contract in a proper manner and as safely as is
feasible. The parties hereto agree that the Contractor retains the
right to control and direct the performance of all work under this
contract. Nothing in this contract shall be deemed to constitute
the Contractor or any subcontractor, agent or employee of the
Contractor, or any other person, organization, institution, or group
of any kind whatsoever, as the agent or employee of the Government.
The Contractor agrees that it has entered into this contract and
will discharge its obligations, duties, and undertakings and the
work pursuant thereto, whether requiring professional judgment or
otherwise, as an independent 



 







 





	 	 	 	Contractor without imputing liability
on the part of the Government for the acts of the Contractor or it
employees.
	 
	 	(c)	 	If at any time during performance of this contract, the
Contracting Officer determines, in consultation with the OHRP, that
the Contractor is not in compliance with any of the requirements
and/or standards stated in paragraphs (a) and (b) above, the
Contracting Officer may immediately suspend, in whole or in part,
work and further payments under this contract until the Contractor
corrects such noncompliance. Notice of the
suspension may be communicated by telephone and confirmed in
writing. If the Contractor fails to complete corrective action
within the period of time designated in the Contracting Officer’s
written notice of suspension, the Contracting Officer may, in
consultation with OHRP, terminate this contract in whole or in
part, and the Contractor’s name may be removed from the list of
those Contractors with approved Health and Human Services Human
Subject Assurances.




H.16 SECURITY PLAN REQUIREMENTS





	 	 	 	The work performed by the contractor at the Acambis and Baxter
operations for manufacturing, ******* distribution will be performed
under a detailed security plan that ensures ******* submit the plan to
the Contracting Officer and Project Officer within 30 calendar days after
award of the contract. The Draft Security Plan shall describe *******
*******.
	 
	 	 	 	The Project Officer and the Information Protection and Systems Security
(IPASS) Coordinator will review the plan and submit comments to the
Contractor within ten (10) calendar days after receipt. The Contractor
shall revise the Security Plan, if required, and submit a final Security
Plan to the Government with ten (10) working days after receipt of the
Government’s comments. A failure to agree on the



 







 





	 	 	 	adequacy of the
contractor’s security plan shall be resolved in accordance with the
provision of Section I, FAR 52.233-1 “Disputes”.
	 
	 	 	 	Performance of work under this contract shall be in accordance with this
written Security Plan.




H.17 ACCESS AND LIMITATION ON DISCLOSURE





	 	 	 	The Contractor shall require each employee to sign a written
Confidentiality Agreement for Access and Limitation on Disclosure
that has been specifically adjusted to the duties assigned, before
access to any federal Information Technology (IT) device or to any
data or information that is exempt from public disclosure (e.g.
Privacy Act, Proprietary, Data Collected Under an Assurance of
Confidentiality, etc.) may be granted. A sample Confidentiality
Agreement from is provided as an attachment in Section J. The
Confidentiality Agreements shall be submitted to the Contracting
Officer and the Project Officer in accordance with Section F.




H.18 DELIVERY ORDER AUTHORITY





	 	 	 	The Contracting Officer or any individual so designated by the
Contracting Officer shall be the only Government officials authorized to
place delivery orders under this contract. The Contractor shall not
accept any delivery order or verbal request from other Government
personnel.



H.19 INCLUSION OF WOMEN AND RACIAL AND ETHNIC MINORITIES IN RESEARCH





	 	 	 	It is the policy of the Centers for Disease Control and Prevention (CDC)
and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black, and
Hispanic. Offerors shall ensure that women, racial, and ethnic minority
populations are appropriately represented in proposals for research
projects involving human subjects. Where a clear and compelling
rationale exists that inclusion is inappropriate or not feasible, this
situation must be explained as part of the proposal. This policy does
not apply to research studies when the investigator cannot control the
race, ethnicity, and/or sex of subjects. Further guidance to this policy
is contained in the Federal Register notice dated September 15, 1995.




H.20 HHSAR 352.270-9(b) CARE OF LIVE VERTEBRATE ANIMALS (Jan 2001)





	 	(a)	 	Before undertaking performance of any contract involving
animal related activities, the Contractor shall register with the
Secretary of Agriculture of the United States in accordance with 7
U.S.C. 2316 and 9 CFR 2.25 through 2.28. The Contractor shall
furnish evidence of such registration to the Contracting Officer.
	 
	 	(b)	 	The Contractor shall acquire vertebrate animals used in
research from a dealer licensed by the Secretary of Agriculture
under 7 



 







 





	 	 	 	U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source
that is exempt from licensing under those sections.
	 
	 	(c)	 	The Contractor agrees that the care and use of any live
vertebrate animals used or intended for use in the performance of
this contract will conform with the PHS Policy on Humane Care and
Use of Laboratory Animals, the current Animal Welfare Assurance, the
Guide for the Care and Use of Laboratory Animals prepared by the
Institute of Laboratory Animal Resources and the pertinent laws and
regulations of the United States Department of Agriculture (see 7
U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of
conflict between standards, the more stringent standard shall be
used.
	 
	 	(d)	 	If at any time during performance of this contract, the
Contracting Officer determines, in consultation with the Office for
Human Research Protection (OHRP), that the Contractor is not in
compliance with any of the requirements and/or standards stated in
paragraphs (a) and (c) above, the Contracting Officer may
immediately suspend, in whole or in part, work and further payments
under this contract until the Contractor corrects such
noncompliance. Notice of the suspension may be communicated by
telephone and confirmed in writing. If the Contractor fails to
complete the corrective action within the period of time designated
in the Contracting Officer’s written notice of suspension, the
Contracting Officer may, in consultation with OHRP, terminate this
contract in whole or in part, and the Contractor’s name may be
removed from the list of those Contractors with approved Public
Health Service Animal Welfare Assurances.
	 
	 	 	 	Note: The Contractor may request registration of his facility and
a current listing of licensed dealers from the Regional Office of
the Animal and Plant Health Inspection Service (APHIS),
USDA, for the region in which its research facility is located.
The location of the appropriate APHIS Regional Office, as well as
information concerning this program may be obtained by contacting
the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale,
Maryland 20737.




H.21 VACCINE DEVELOPMENT SITE





	 	 	 	The vaccine development site for this contract shall be at the address
shown below. Alternate sites may be used upon receipt of written
approval from the Contracting Officer.



          *******




H.22 MANUFACTURING SITE





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



          *******

 







 



           
*****



           
*****



           
*******)




H.24 GOVERNMENT ASSISTANCE





	 	 	 	The Government undertakes to provide the full cooperation of the
DHHS, CDC, FDA, and other regulatory authorities in order to
facilitate the Contractor’s efforts to develop and obtain licensure
of the smallpox vaccine as expeditiously as reasonably possible. All
available data, clinical studies and other materials in the
possession of such agencies shall be made available as soon as
possible for due diligence review and for use under this agreement.




H.25 RESTRICTED AWARD – HUMAN SUBJECT





	 	 	 	This contract requires the awardees to participate in the development
and implementation of new study protocols involving human subjects.
Under governing regulations, Federal funds which are administered by
the Centers for Disease Control and Prevention (CDC) shall not be
expended by the awardees for research involving human subjects, nor
shall human subjects be involved in research activities by the
awardees under this award unless satisfactory evidence of approval by
the awardee’s Institutional Review Board for the Protection of Human
Subjects (IRB) is submitted to CDC by the awardees within 40 days of
development of the protocol by the Steering Committee. Each
performance site (if any) must also assure compliance with 45 CFR 46
and receive the IRB’s approval before expenditure of funds or
involvement of human subjects. The present award is being made
without evidence of IRB approval with the following restriction:
only activities which do not directly involve human subjects (i.e.,
are clearly severable and independent from those activities that do
not involve human subjects) may be conducted by the awardee or
individual performance sites pending IRB approval of their respective
protocols.




H.26 GOVERNMENT FURNISHED PROPERTY





	 	 	 	The following property from Contract No. 200-2000-00001 will be
furnished to the Contractor within five (5) calendar days after award of
the contract:





	 	1.	 	3 vials of master virus seed (*******QC tested)
	 
	 	2.	 	5 vials of production virus seed



 







 



H.27 RIGHTS OF THE CONTRACTOR TO MARKET SMALLPOX VACCINE





	 	 	 	The Contractor is not prohibited from marketing the smallpox vaccine
developed under this contract provided that such marketing does not
interfere with performance under this contract.



 







 



Section I — Contract Clauses

Section I-1 — Clauses Incorporated By Reference




I.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)





	 	 	 	This contract incorporates one or more 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/these
address(es):
	 
	 	 	 	http://www.arnet.gov/far/




	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.202-1	 	
Definitions (Oct 1995)
	52.203-3	 	
Gratuities (Apr 1984)
	52.203-5	 	
Covenant Against Contingent Fees (Apr 1984)
	52.203-6	 	
Restrictions on Subcontractor Sales to the Government (Jul
1995)
	52.203-7	 	
Anti-Kickback Procedures (Jul 1995)
	52.203-8	 	
Cancellation, Rescission, and Recovery of Funds for Illegal
or Improper Activities (Jan 1997)
	52.203-10	 	
Price or Fee Adjustment for Illegal or Improper Activity (Jan

1997)
	52.203-12	 	
Limitation on Payment to Influence Certain Federal
Transactions (Jun 1997)
	52.204-4	 	
Printing/Copying Double-Sided on Recycled Paper (Aug 2000)
	52.209-6	 	
Protecting the Government’s Interest When Subcontracting with
Contractors Debarred, Suspended, or Proposed for Debarment
(Jul 1995)
	52.215-2	 	
Audit and Records – Negotiation (Jun 1999)
	52.215-8	 	
Order of Precedence – Uniform Contract Format (Oct 1997)
	52.215-14	 	
Integrity of Unit Prices (Oct 1997)
	52.215-18	 	
Reversion or Adjustment of Plans for Postretirement Benefits
(Oct 1997)
	52.217-7	 	
Option for Increased Quantity-Separately Priced Line Item

(Mar 1989)
	52.219-8	 	
Utilization of Small Business Concerns (Oct 1999)
	52.222-3	 	
Convict Labor (Aug 1996)
	52.222-26	 	
Equal Opportunity (Feb 1999)
	52.222-35	 	
Affirmative Action for Disabled Veterans and Veterans of the
Vietnam Era (Apr 1998)
	52.222-36	 	
Affirmative Action for Workers with Disabilities (Jun 1998)
	52.222-37	 	
Employment Reports on Disabled Veterans and Veterans of the
Vietnam Era (Jan 1999)
	52.223-6	 	
Drug-Free Workplace (Jan 1997)
	52.223-12	 	
Refrigeration Equipment and Air Conditioners (May 1995)
	52.223-14	 	
Toxic Chemical Release Reporting (Oct 1996)
	52.224-1	 	
Privacy Act Notification (Apr 1984)
	52.224-2	 	
Privacy Act (Apr 1984)
	52.225-3	 	
Buy American Act — Supplies (Feb 2000)
	52.226-1	 	
Utilization of Indian Organizations and Indian-Owned Economic
Enterprises (Jun 2000)
	52.227-1	 	
Authorization and Consent (Jul 1995) Alternate I (Apr 1984)



 







 



	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.227-11	 	
Patent Rights-Retention by the Contractor (Short Form) (Jun

1997, Alternate II (Jun 1989)
	52.227-14	 	
Rights and Data-General (Jun 1987) Alternate I (Jun 1987)
	52.227-16	 	
Additional Data Requirements (Jun 1987)
	52.227-2	 	
Notice and Assistance Regarding Patent and Copyright
Infringement (Aug 1996)
	52.229-3	 	
Federal, State, and Local Taxes (Jan 1991)
	52.229-5	 	
Taxes—Contracts Performed in U.S. Possessions or Puerto Rico
(Apr 1984)
	52.232-1	 	
Payments (Apr 1984)
	 	 	 
	52.232-9	 	
Limitation of Withholding of Payments (Apr 1984)
	52.232-11	 	
Extras (Apr 1984)
	52.232-17	 	
Interest (Jun 1996)
	52.232-18	 	
Availability of Funds (Apr 1984)
	52.232.22	 	
Limitation of Funds (Apr 1984)
	52.232-23	 	
Assignment of Claims (Jan 1986)
	52.232-25	 	
Prompt Payment (Jun 1997)
	52.232-34	 	
Payment by Electronic Funds Transfer — Other than Central
Contractor Registration (May 1999)
	52.233-1	 	
Disputes (Dec 1998) Alternate I (Dec 1991)
	52.233-3	 	
Protest after Award (Aug 1996) Alternate I (Jun 1985)
	52.242-13	 	
Bankruptcy (Jul 1995)
	52.243-1	 	
Changes—Fixed-Price (Aug 1987) Alternate V (Apr 1984)
	52.244-5	 	
Competition in Subcontracting (Dec 1996)
	52.245-2	 	
Government Property (Fixed Price Contracts) (Dec 1989)
	52.249-2	 	
Termination for Convenience of the Government (Fixed-Price)
(Sep 1996)
	52.249-8	 	
Default (Fixed-Price Supply and Service) (Apr 1984)
	52.253-1	 	
Computer Generated Forms (Jan 1991)
	 
	HHSAR SOURCE	 	TITLE AND DATE
	352.202-1	 	 
	352.224-70	 	
Confidentiality of Information (Apr 1984)
	352.232-9	 	
Withholding of Contract Payment (Apr 1984)
	352.270-6	 	
Publications and Publicity (Jul 1991)
	352.270-7	 	
Paperwork Reduction Act (Apr 1984)



 







 



Section I-2 — Clauses Incorporated In Full Text




I.2 FAR 52.215-19 NOTIFICATION OF OWNERSHIP CHANGES (OCT 1997)





	 	(a)	 	The Contractor shall make the following notifications in writing:





	 	(1)	 	When the Contractor becomes aware that a change
in its ownership has occurred, or is certain to occur, that
could result in changes in the valuation of its capitalized
assets in the accounting records, the Contractor shall notify
the Administrative Contracting Officer (ACO) within 30 days.
	 
	 	(2)	 	The Contractor shall also notify the ACO within
30 days whenever changes to asset valuations or any other cost
changes have occurred or are certain to occur as a result of a
change in ownership.





	 	(b)	 	The Contractor shall–





	 	(1)	 	Maintain current, accurate, and complete
inventory records of assets and their costs;
	 
	 	(2)	 	Provide the ACO or designated representative
ready access to the records upon request;
	 
	 	(3)	 	Ensure that all individual and grouped assets,
their capitalized values, accumulated depreciation or
amortization, and remaining useful lives are identified
accurately before and after each of the Contractor’s ownership
changes; and
	 
	 	(4)	 	Retain and continue to maintain depreciation and
amortization schedules based on the asset records maintained
before each Contractor ownership change.





	 	(c)	 	The Contractor shall include the substance of this clause in
all subcontracts under this contract that meet the applicability
requirement of FAR 15.408(k).




	 	 	 
	I.3	 	
FAR 52.215-21 REQUIREMENTS FOR COST OR PRICING DATA OR INFORMATION
OTHER THAN COST OR PRICING DATA - MODIFICATIONS (OCT 1997) ALTERNATE IV
(OCT 1997)





	 	(a)	 	Submission of cost or pricing data is not required.
	 
	 	(b)	 	Provide information described below:
	 
	 	 	 	If information is required to determine reasonableness of an
equitable adjustment in the price for a line item(s), the
information to be provided by the Contractor shall include an
itemized cost breakdown of applicable unit price(s). The cost
breakdown shall include, as a minimum, the type of labor, estimated
number of hours, and hourly rate for each labor category, fringe
benefits, overhead, other direct costs, general and administrative,
and profit. The requirement of this clause does not entitle the
Government to require such information to support the prices
included in the contract at time of award.



 







 



I.4 FAR 52.216-18 ORDERING (OCT 1995)





	 	(a)	 	Any supplies and services to be furnished under this contract
shall be ordered by issuance of delivery orders or task orders by
the individuals or activities designated in the Schedule. Such
orders may be issued from the date of award through the expiration
date of the contract.
	 
	 	(b)	 	All delivery orders or task orders are subject to the terms
and conditions of this contract. In the event of conflict between a
delivery order or task order and this contract, the contract shall
control.
	 
	 	(c)	 	If mailed, a delivery order or task order is considered
“issued” when the Government deposits the order in the mail. Orders
may be issued orally, by facsimile, or by electronic commerce
methods only if authorized in the Schedule.




I.5 FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)





	 	(a)	 	Minimum order. When the Government requires supplies or
services covered by this contract in an amount of less than
50,000,000 doses, the Government is not obligated to purchase, nor
is the Contractor obligated to furnish, those supplies or services
under the contract.
	 
	 	(b)	 	Maximum order. The Contractor is not obligated to honor—





	 	(1)	 	Any order for a single item in excess of 250,000,000 doses;
	 
	 	(2)	 	Any order for a combination of items in excess of
250,000,000 does; or
	 
	 	(3)	 	A series of orders from the same ordering office
within ten days that together call for quantities exceeding
the limitation in subparagraph (1) or (2) of this section.





	 	(c)	 	If this is a requirements contract (i.e., includes the
Requirements clause at subsection 52.216-21 of the Federal
Acquisition Regulation (FAR)), the Government is not required to
order a part of any one requirement from the Contractor if that
requirement exceeds the maximum-order limitations in paragraph (b)
of this section.
	 
	 	(d)	 	Notwithstanding paragraphs (b) and (c) of this section, the
Contractor shall honor any order exceeding the maximum order
limitations in paragraph (b), unless that order (or orders) is
returned to the ordering office within five (5) working days after
issuance, with written notice stating the Contractor’s intent not to
ship the item (or items) called for and the reasons. Upon receiving
this notice, the Government may acquire the supplies or services
from another source.



 







 






I.6 FAR 52.216-22 INDEFINITE QUANTITY (Oct 1995)





	 	(a)	 	This is an indefinite-quantity contract for the supplies or
services specified, and effective for the period stated, in the
Schedule. The quantities of supplies and services specified in the
Schedule are estimates only and are not purchased by this contract.
	 
	 	(b)	 	Delivery or performance shall be made only as authorized by
orders issued in accordance with the Ordering clause. The
Contractor shall furnish to the Government, when and if ordered, the
supplies or services specified in the Schedule up to and including
the quantity designated in the Schedule as the “maximum.” The
Government shall order at least the quantity of supplies or services
designated in the Schedule as the “minimum.”
	 
	 	(c)	 	Except for any limitations on quantities in the Order
Limitations clause or in the Schedule, there is no limit on the
number of orders that may be issued. The Government may issue
orders requiring delivery to multiple destinations or performance at
multiple locations.
	 
	 	(d)	 	Any order issued during the effective period of this contract
and not completed within that period shall be completed by the
Contractor within the time specified in the order. The contract
shall govern the Contractor’s and Government’s rights and
obligations with respect to that order to the same extent as if the
order were completed during the contract’s effective period;
provided, that the Contractor shall not be required to make any
deliveries under this contract after the expiration date of the
delivery order.




	 	 	 
	I.7	 	
FAR 52.244-6 SUBCONTRACTS FOR COMMERCIAL ITEMS AND COMMERCIAL
COMPONENTS (OCT 1998)





	 	(a)	 	Definitions.
	 
	 	 	 	“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 Contractor shall
incorporate, and require its subcontractors at all tiers to
incorporate, commercial items or nondevelopmental items as
components of items to be supplied under this contract.
	 
	 	(c)	 	Notwithstanding any other clause of this contract, the
Contractor is not required to include any FAR provision or clause,
other than those listed below to the extent they are applicable and
as may be required to establish the reasonableness of prices under
Part 15, in a subcontract at any tier for commercial items or
commercial components:





	 	(1)	 	52.222-26, Equal Opportunity (E.O. 11246);
	 
	 	(2)	 	52.222-35, Affirmative Action for Disabled Veterans and
Veterans of the Vietnam Era (38 U.S.C. 4212(a));



 







 





	 	(3)	 	52.222-36, Affirmative Action for Workers with Disabilities
(29 U.S.C. 793); and
	 
	 	(4)	 	52.247-64, Preference for Privately-Owned U.S.-Flagged
Commercial Vessels (46 U.S.C. 1241)(flow down not required
for subcontracts awarded beginning May 1, 1996).





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




I.8 INCORPORATION OF TECHNICAL PROPOSAL





	 	 	 	Pages 6 through 20 of the technical approach, contained in the
contractor’s technical proposal dated November 2, 2001 are incorporated
herein by reference. Any variation or deviation from the planned
approach shall be coordinated with the Government Project Officer as
provided for in Section G.4(b). Provided, however, that should there be
a conflict among the provisions of the technical proposal pages as
incorporated, and the contract provisions, the contract provisions shall
prevail.



 







 



Section J — List Of Attachments





	J.1	 	 Applicable Documents
	 
	J.2	 	 Contractor Performance Report
	 
	J.3	 	 ACH Miscellaneous Payment Enrollment Form
	 
	J.4	 	 Order for Supplies or Services, Optional Form 347 (Rev.6/95)
	 
	J.5	 	 Sample Confidentiality Agreement
	 
	J.6	 	 Sample Security Plan
	 
	J.7	 	 09-20-0136, Epidemiologic Studies and Surveillance of Disease Problems