exv4w36



 


EXHIBIT 4.36



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.





	 	 	 	 	 	 	 
		 	
38 Sidney St., Cambridge, MA 02139
	 	Phone: (617) 494-1339
	 	Fax: (617) 494-1741




	 	 	 
	PURCHASE ORDER 28890	 	
Subcontract 200-2002-00012(CBL)(Mod 0002)




	 	 	 	 	 	 	 	 	 
	Requested by:	 	 	 	Authorization:	 	 	 	 
	[ **** ]	 	
1.
	 	 	 	2.
	 	9/10/02
	 	 	 	 	
	 	 	 	 




	 	 	 
	Vendor Name (Address & Phone if new vendor)	 	
Special Instructions: Payment Terms:
	 	 	 
	Chesapeake Biological Laboratories, Inc.

1111 S. Paca Street

Baltimore MD 21230	 	
(1) ACAM 2000 US Govt Program

(2) All of the Subcontract 200-2002-00012(CBL) terms and conditions apply to

this purchase order as modified below.




	 	 	 	 	 	 	 	 	 	 	 
	Customer Order No.:	 	 	 	Date Needed:
	 	 	 	Date Requested:	 	 
	 	 	


	 	 	 	

	 	 	 	






	 	 	 	 	 	 	 	 	 
	Line #	 	Quantity	 	Unit	 	Description	 	Actual Price
	
	 	
	 	
	 	
	 	

	1	 	
1

Exp
	 	 

Project
	 	Develop/Transfer Cleaning Procedure, including drafting, re-formatting,
and finalizing cleaning Standard Operating Procedure (“SOP”) to reflect
Acambis’s change [ **** ]
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	2	 	
1

Exp
	 	 

Project
	 	Transfer/Train Vessel Assembly Procedure, including drafting, training,
evaluating, re-formatting and finalizing vessel assembly SOP to reflect
Acambis’s change [ **** ]
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	3	 	
1

Exp
	 	 

Project
	 	Transfer/Train Vessel Decontamination Procedure, including evaluating
method and preparing, trying, refining, and finalizing vessel
decontamination SOP to reflect Acambis’s change [ **** ].
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	4	 	
1

Exp
	 	 

Project
	 	Develop/Train Vessel
Receipt Inspection [****], including determining
new tamper evident process; determining necessary release
specifications; and drafting, trying, refining steps, and finalizing
vessel receipt inspection SOP [ **** ] to reflect Acambis’s change [
**** ] .
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	5	 	
1

Exp
	 	 

Project
	 	Update Related SOPs, including reviewing the list of SOPs and
completing SOPs to reflect Acambis’s change [ **** ]. After CBL
completes these SOPs, the Acambis Quality Assurance (“QA”) department
will review and provide their comments to CBL. CBL may invoice for
this item following resolution of all the comments contained in that
review process.
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	6	 	
1

Exp
	 	 

Project
	 	 

Update and Finalize Safety Plan to reflect Acambis’s change [ **** ]
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	7	 	
1

Exp
	 	 

Project
	 	 

Revise transfer validation record to reflect Acambis’s change [ **** ]
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	8	 	
1

Exp
	 	 

Project
	 	 

Revise/Approve Media fill record
	 	[ **** ]



 







 



	 	 	 	 	 	 	 	 	 
	Line #	 	Quantity	 	Unit	 	Description	 	Actual Price
	
	 	
	 	
	 	
	 	

	9	 	
1

Exp
	 	 

Project
	 	Revise Master Batch Record,
including implementing changes
for the new process, finish
sampling plan (liquid, FP),
define rejects – product on
stopper, and approve record
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	10	 	
1

Exp
	 	 

Project
	 	[ **** ] process validation
– SIP of Pooling/Product
Delivery, [ **** ] , plan
assembly, prepare protocol,
approve protocol, conduct
temperature and B/I trials
(1,2+3), incubate B/Is (#s
1,2+3), read B/I’s trials
(#s1,2,+3), prepare report,
draft SOP [ **** ]
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	11	 	
1

Exp
	 	 

Project
	 	[ **** ] process validation
– [ **** ] Qualification,
including: (1) for non-qualified
vessels [****], receiving,
training on assembly of vessels,
qualifying (IQ/OQ) non-qualified
vessels, and assigning CBLINC#;
(2) for qualified vessels
[****], receiving, qualifying
(IQ/OQ), and assigning CBLINC#;
and (3) for qualified vessels
[****], receiving, qualifying
(IQ/OQ), and assigning CBLINC#.
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	12	 	
1

Exp
	 	 

Project
	 	Placebo fill, including issuing
batch record, preparing for
fill, receiving and releasing 3
bags of placebo from Acambis,
performing thawing the placebo,
filling, lyophilization capping,
inspection, bulk packaging,
moisture testing (1 set of
samples for each shelf utilized
in the lyophilizer for this
fill) and reviewing the record.
All work to be performed in
substantial compliance with the
Product Statement of Work,
Section J, Attachment A,
Subcontract 200-2002-00012(CBL),
Mod 0001. Provide all testing
results, including for moisture
content, to Acambis for review.
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	13	 	
2

Exp
	 	 

Project
	 	Media manipulation (pooling and
transfer), including issuing
batch record, preparing for
transfer validation, receiving
and releasing [****]
from Acambis, thawing media,
conducting transfer, 7 day read
of incubation, 14 day read of
incubation, and review record.
Provide all media test results
to Acambis for review. (Each
media manipulation is [ **** ]
). An acceptable media
manipulation is defined as a
pooling and transfer where the
media test results shows no
growth in the pooled and
transferred media.
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	14	 	
1

Exp
	 	 

Project
	 	Media Fill (pooling with vial
fill), including issuing batch
record; preparing for transfer
validation; receiving and
[****] from
Acambis; thawing media;
conducting fill, lyophilization
demonstration, and capping; 7
day read of incubation, 14 day
read of incubation, and review
record. All work to be
performed in substantial
compliance with the Product
Statement of Work, Section J,
Attachment A, Subcontract
200-2002-00012(CBL), Mod 0001.
Provide all test results to
Acambis for review. An
acceptable media fill is defined
as a fill where the media test
results show no growth in the
vialed media.
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	15	 	
1

Exp
	 	 

Project
	 	Engineering run (VV02-003),
including issuing batch record;
preparing for the engineering
run, receiving and releasing [
**** ] from Acambis, thawing[
**** ] , conducting fill,
lyophilization, capping,
inspection, bulk packaging, and
moisture testing (1 set of
samples for each shelf utilized
in the lyophilizer for this
fill), and reviewing record.
All work to be performed in
substantial compliance with the
Product Statement of Work,
Section J, Attachment A,
Subcontract 200-2002-00012(CBL),
Mod 0001. Provide all testing
results, including for moisture
content, to Acambis for review.
	 	[ **** ]
	 	 	 	 	 	 	 	 	 
	16	 	
1

Exp
	 	 

Project
	 	Shipment simulation, including
defining validation
requirements, arranging shipment
(diluent and placebo), preparing
shipment (cases and labels), and
shipping diluent and placebo.
	 	[ **** ]



2







 



	 	 	 	 	 	 	 	 	 
	Line #	 	Quantity	 	Unit	 	Description	 	Actual Price
	
	 	
	 	
	 	
	 	

	17	 	
1

Exp
	 	 

Project
	 	Develop/Review Autoclave
Cycle, including
reviewing cycles,
preparing load
configuration documents,
revising SOP’s
BMF-MAT-6019, -6020,
-6021 and verifying
programmed cycle
parameters to reflect
Acambis’s change [ **** ]
	 	[ **** ]




	 	 	 	 	 	 	 	 	 	 	 
	 	 	
 
	 	 
	 	 
	 	Total
	 	$644,000





	 	(A)	 	This Modification 002 increases the estimated total price of PO 28890 from: [ **** ] by: [ **** ] to: [ **** ]
	 
	 	(B)	 	By signing this purchase order, CBL acknowledges and agrees that CBL is not entitled to a “missed fill” payment otherwise due under Subcontract
200-2002-00012(CBL), Section H, Paragraph H.3(a)(i) for the one (1) scheduled fill closest to each of the dates CBL performs the placebo fill (Line
#13), media fill (Line #15), and the engineering fill (VV02-003) (Line #16) for a total of three (3) waived missed fills.
	 
	 	(C)	 	This purchase order includes all adjustments relating to validating the Product Transfer Process to which CBL is entitled for the Acambis
changes to the ACAM 2000 Vaccine Statement of Work arising out of the change to the [ **** ] and the requirement that CBL treat the pre-IND
vaccine as hazardous materials and utilize [ **** ] containers to ship all packaged vaccine.
	 
	 	(D)	 	Acambis will pay Invoice 8386 [75% of the total of Line Numbers 13, 15, 14, 2, 3, 4, 8, and 9] (as amended 8/23/02) upon receipt of a
certificate of conformance from CBL. Time for payment of Invoice 8425 [representing 25% of the total of Line Numbers 13, 15, 14, 2, 3, 4, 8, and
9] (dated 8/23/02) is ten days after receipt of acceptable CBL final batch records. Time for payment for the remainder of the tasks described in
this purchase order is 30 days after receipt of a proper invoice or 10 days after receipt of acceptable CBL final batch records, whichever is
later.



     *****This Purchase Order is invalid without an assigned PO#




	 	 	 	 	 	 	 	 	 	 	 
	Company Representative	 	 	 	Date 9/9/02
	 	 	 	Confirmation No.	 	 
	 	 	


	 	 	 	

	 	 	 	






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