exv4w31



 



Exhibit 4.31


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.








ACAMBIS SUBCONTRACT MODIFICATION 0003



Subcontract No.: 200-2002-00010(BXTR)



Modification No.: 0003



Effective Date: December 20, 2002




	 	 	 	 	 
	Subcontractors:	 	
Baxter Healthcare SA
	 	Baxter Healthcare Corporation
	 	 	
Hertistrasse 2
	 	One Baxter Parkway
	 	 	
CH-8304 Wallisellen, Switzerland
	 	Deerfield, IL 60015



Description of Modification:



     [ **** ]



Authority for, and type of, modification: Bilateral Supplemental Agreement



Total Subcontract value change: $0.00



Changes to Subcontract:




	 	 	 
	Deletes	 	
Subcontract Sections A.1, A.2, B, C (Items 0001 and 0003), and G.8
	 	 	 
	Adds	 	
The attached modified Subcontract Sections A.1, A.2, B, C (Items 0001 and
0003), and G.8.



RELEASE OF CLAIMS

In consideration of the modifications made above, this Modification is in full
settlement of any Subcontractors right to equitable adjustment as the result of
the changes made herein. Except to the extent modified herein, the subcontract
terms and conditions remain unchanged. This supplemental agreement constitutes
the full agreement of the parties and supercedes any prior agreements with
respect to the changes made herein.




	 	 	 
	For: ACAMBIS, INC	 	
For: BAXTER HEALTHCARE S.A. and
	 	 	
BAXTER HEALTHCARE CORPORATION
	 	 	 
	[ **** ]	 	
[ **** ]
	 	 	 
	Execution Date December 20, 2002	 	
Execution Date December 20, 2002




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION



 







 





Modification 0003



Section A — Introduction




	 	 	 
	A.1	 	
BACKGROUND
	 	 	 
	 	 	
The United States Government has recognized the need to maintain a stockpile of 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 awarded Acambis Inc. a contract to develop, license,
manufacture, and [ **** ] , in quantities as may be
ordered by the Government, [ **** ].
	 	 	 
	A.2	 	
PURPOSE
	 	 	 
	 	 	
The purpose of this Subcontract is for Contractor to purchase crude bulk
vaccine from the 1st Subcontractor sufficient to produce an estimated 155
million doses of such vaccine (with a maximum total quantity of [ **** ]
doses), as an investigational new drug (“IND”). [ **** ]




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION



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Modification 0003



Section B – Schedule of Subcontract ITEMs/Prices




	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Estimated	 	Unit	 	Estimated
	ITEM	 	 	 	Description	 	Quantity	 	Price	 	Total Amount
	
	 	 	 	
	 	
	 	
	 	

	0001	 	
–
	 	Bulk Vaccine/Partial Kit Assembly	 	 	 	 
	 	 	 	 	-Preliminary kit (IND)(initial order)**	 	 	 	 
	 	 	 	 	 	 	 	 	 
	 	 	 	 	0001A Crude Bulk Vaccine
	 	155,000,000 doses
	 	[ **** ]	 	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	 	 	 	 	0001B Partial Kit Assembly
	 	1,550,000 Kits*
	 	[ **** ]	 	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	0002	 	
–
	 	Bulk Vaccine/Partial Kit Assembly	 	 	 	 
	 	 	 	 	-Preliminary kit (IND)**	 	 	 	 
	 	 	 	 	 	 	 	 	 
	 	 	 	 	0002A Crude Bulk Vaccine
	 	[ **** ]	 	[ **** ]	 	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	 	 	 	 	0002B Partial Kit Assembly
	 	[ **** ]	 	[ **** ]	 	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	 	 	 	 	[ **** ]	 	 	 	 
	 	 	 	 	 	 	 	 	 
	 	 	 	 	[ **** ]	 	 	 	 




Title, Risk of Loss and Invoices for Crude Bulk Vaccine



1.     The [ **** ] shall, with at least ten (10) working days advance notice
to the Contractor, ship crude bulk vaccine conforming to the Subcontract
requirements from [ **** ]. Each lot of crude bulk vaccine shipped to
Contractor shall be accompanied with a Certificate of Conformance (Section J,
Attachment B) to the effect that shipped crude bulk vaccine conforms to
Subcontract requirements.



2.     Legal title to such crude bulk vaccine shall pass to the Contractor upon
shipment from [ **** ] however, due to the sensitive nature of the crude
bulk vaccine and the 1st Subcontractor’s transportation and logistics
capabilities, the [ **** ] shall continue to be responsible for and bear all
risks of loss or damage to the crude bulk vaccine, cost of insurance, freight
and transportation until Contractor’s receipt of such crude bulk vaccine at
Contractor’s facility [ **** ] . Upon Contractor’s receipt of each
shipment of crude bulk vaccine, Contractor shall thereafter assume all future
risks of loss or damage to such vaccine when the vaccine is processed,
returned, and received [ **** ].



3.     [ **** ]



4.     The [ **** ] shall submit an invoice for each lot of crude bulk vaccine
(exclusive of pilot lots) shipped from [ **** ]  to
[ **** ]  for manufacture of kits
under Subcontract Item(s) 0001 and/or 0002. Initially, such invoices shall be
based upon the assumption that each lot of crude bulk vaccine delivered to
Contractor, shall yield[ **** ] after down-stream processing, purification,
and lyophilization. (For example, under ITEM 0001A, [ **** ] ). Subsequent
invoices for future crude bulk lots shipped for manufacture of kits under
Item(s) 0001 and/or 0002 shall be based on anticipated actual yields as agreed
to by the parties. Crude bulk vaccine in excess of that required to manufacture
vaccine kits for the U.S. Government under this Subcontract shall be processed
and finished into vaccine kits for commercial sales under the terms of a
separate commercial sales agreement between Contractor and the 1st
Subcontractor.



5.     Notwithstanding any other provision of this Subcontract, except Section C,
ITEM 0001, Paragraph A.4, payment for ITEMs 0001 and 0002 shall be made and be
due at the earlier of: (1) thirty (30) days after the US Government makes
payment to Contractor for completed kits accepted by the Government under the
terms of Contractor’s Prime Contract (See Paragraph G.2) upon due performance
by the Subcontractors of Subcontract ITEM(s) 0001 and 0002 and Subcontractors’
submission of proper invoices for the actual number of kitted vaccine delivered
and accepted by the Contractor; or (2) on December 31, 2003 for the amounts
invoiced for each lot of crude bulk vaccine, as described above, ordered under
Delivery Order 0001; or (3) on December 31, 2005 for the amounts invoiced for
each lot of crude bulk vaccine, as described above, ordered after Delivery
Order 0001. In no event shall Subcontractor(s) be paid more under this
Subcontract than the Subcontract price shown above for ITEMs 0001 and 0002 for
the number of kits




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION



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Modification 0003



delivered and accepted unless the Contractor orders additional crude bulk
vaccine for which it is obligated to make payment under Section C, ITEM 0001,
Paragraph A.7. below.




	 	 	 	 	 	 	 	 	 	 	 
	0003	 	
–
	 	Kit and Component [ **** ] 
	 	[ **** ]	 	[ **** ]	 	[ **** ]
	 	 	 	 	 	 	 
	0004	 	
–
	 	Label Vaccine/Diluent
	 	[ **** ]	 	[ **** ]	 	[ **** ]
	 	 	 	 	And Re-kit after-Licensure	 	 
	 	 	 	 	[ **** ]	 	 
	 	 	 	 	 	 	 
	0005A	 	
–
	 	Final Kit Assembly and
	 	[ **** ]	 	[ **** ]	 	[ **** ]
	 	 	 	 	Distribution of Vaccine and	 	 
	 	 	 	 	Diluent after Licensure	 	 
	 	 	 	 	 	 	 
	0005B	 	
–
	 	Labeling, Final Kit Assembly,
and Distribution of IND
Vaccine and Diluent
	 	[ **** ]	 	[ **** ]	 	[ **** ]




** As ordered, ITEMs 0005A and 0005B
combined shall not exceed [ **** ].




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	0006	 	–	 	Data—Not Separately Priced
	 	 	 	 	 	 	 
	0007	 	–	 	Payment for Additional Services
	 	 	 	 	– Payable as specified in Paragraph H.26.
	 	 	 	 	 	 	 
	 	 	 	 	0007A	 	[ **** ]	[ **** ]
	 	 	 	 	 	 	 
	 	 	 	 	0007B	 	[ **** ]	 
	 	 	 	 	 	 	[ **** ]	[ **** ]




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION



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Modification 0003



Section C – Description/Specification/Work Statement (References to “TBD” shall
be determined by Mutual Agreement of the Parties)



ITEM 0001- Manufacture of Bulk Vaccine and Partial Kit Assembly



          [ **** ]



ITEM 0003- [ **** ]



     [ **** ]



     2nd Subcontractor shall provide samples of vaccine and diluent to
Contractor from time to time, according to a schedule to be provided by
Contractor, for stability tests (performed by Contractor). Samples shall
correspond to individual lots of vaccine and diluent. Samples will be shipped
to Contractor’s Quality Control laboratory on dry ice at Contractor’s expense.




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION



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Modification 0003



G.8 ISSUANCE OF DELIVERY ORDERS (Applicable to All Subcontract ITEMs)





	(a)	 	Orders for work to be performed by the
Subcontractors under this Subcontract shall be placed by
means of Delivery Orders. (See Section J, Attachment C).
Delivery Orders may be issued in writing, by facsimile, or
e-mail with electronic signature. (See Paragraph I.1).
	 
	(b)	 	Delivery Orders issued under this Subcontract
shall contain, at a minimum, the following information:





	 	(1)	 	Delivery Order, Subcontract, and
Prime Contract Numbers;
	 
	 	(2)	 	Quantity of ITEM(s) Ordered;
	 
	 	(3)	 	Unit Price;
	 
	 	(4)	 	Extended Price; and
	 
	 	(5)	 	Consignee Name and Address;
	 
	 	(6)	 	Consignee contact name and
telephone number.





	(c)	 	Ordering Period:





	 	(1)	 	ITEMs 0001 and 0002: From
Subcontract award until [ **** ] , or such later
period as the parties may agree in writing.
	 
	 	(2)	 	ITEMs 0003, 0004, and 0005: From Subcontract award
until [ **** ] , or such later period as the parties may
agree in writing.





	(d)	 	Contractor may issue Delivery Orders at any
time during the stated ordering period. The period of
performance for a delivery order may extend beyond the
ordering period.
	 
	(e)	 	Delivery Order Authority: The Contractual
Officer or any individual so
designated in writing by the Contractual Officer shall be the
only Contractor representative authorized to place Delivery
Orders under this Subcontract. The Subcontractor(s) shall not
accept any Delivery Order or verbal request from any other
Contractor representative or any Government personnel.
	 
	(f)	 	All Delivery Orders issued under this
Subcontract shall be sent to the Subcontractor as follows:





	 	 	(1) 1st Subcontractor:
	 
	 	 	NAME: [ **** ] 
	 	 	
with informational copy to:
	 
	 	 	[ **** ]




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION



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Modification 0003





	(1)	 	2nd Subcontractor:
	 
	 	 	[ **** ]
	 
	 	 	with informational copy to:
	 
	 	 	[ **** ]
	 
	(g)	 	Contractor designates the following individual
and agrees to make such individual available to allow
Subcontractors to confirm receipt of Contractor’s Delivery
Order(s) in the event that the Contractual Officer is
unavailable:
	 
	 	 	[ **** ]




	 	 	 
	ADDRESS:	 	
Acambis Inc

38 Sidney Street

Cambridge, MA 02139





	 	 	[ **** ]




ACAMBIS CONFIDENTIAL-PROPRIETARY INFORMATION





7