Document:

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.	 	 
	 	 	

	 	 	 	

	 	 	 	

3exv4w37

 

Exhibit 4.37

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

Subcontract Number: 200-2002-00012(CBL) (PO 28890)

Modification Number: 0003

Effective Date: This Subcontract modification is effective as of the last signed date below.

	 	 	 
	Subcontractor:	 	
Chesapeake Biological Laboratories, Inc.
	 	 	
1111 S. Paca Street
	 	 	
Baltimore, MD 21230-2591

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

Description of Modification:

	 	 	 
	Clause B.1	 	
Increases the “Firm Fixed Price” and the “Total Amount” to
account for a supplemental payment for third fills under Item
0001A
	Clause B.2	 	
Changes “Quantity” from [ **** ] to the [ **** ] of Item 0002
	Table 1	 	
Adds [ **** ] supplemental payment for each third fill
under Item 0001A product
	Clauses B.4, B.5,
and B.6	 	
Clarifies that the “Estimated Quantity” is stated in vials
	Clause B.8	 	
Adds provision for the General Release and invoicing for such release
	Clause E.1	 	
Clarifies the acceptance procedure for filled vials (paragraphs (c) and (d))
	Clause F.1(b)	 	
Clarifies the timing of the Item 0001B change-over and modifies the Item 0004B delivery date
	Clause F.2	 	
Modifies the period of performance for Items 0001A, 0001B, 0002, 0003A, 0003B, 0004A, and 0004B
	Clause G.1	 	
Deletes reference to general safety and microbial limits test and adds a reference to paragraph
H.3.1 in paragraph (xiii) (paragraph (2)), clarifies acceptance procedures (paragraph (3)) and
adds a Government/Buyer Property provision (paragraph (4)).
	Clause G.2(f)	 	
Modifies the ordering periods for Items 0003A, 0003B, 0004A, and 0004B.
	Clause H.3	 	
Modifies missed fill provision and deletes “partial fill” underutilization fee
	Clause H.3.1	 	
Adds provision relating performing scheduled fills [ **** ] and potential extensions
to the filling period
	Clause H.4	 	
Modifies guaranteed payment and advance payment provisions
	Clause H.5	 	
Modifies planned schedule and notification of bulk vaccine shipment provisions
	Clause H.6	 	
Replaces Validation of Consistency of Manufacture provision
	Clause H.6.1	 	
Adds provision [ **** ]
	Clause H.17	 	
Modifies property provision to cover Buyer-furnished property
	Section J	 	
Modifies Attachments to include new planned vaccine schedule, Buyer-Furnished Property,
Modification 0003 general release, and Statement of Work Modification 0001

 

 

Total Change to Subcontract Amount:

	 	 	 	 	 	 
	 	 	
Item 0001A 

Item 0002 

Item 0008 

	 	[ **** ]

[ **** ]

[ **** ]
	[ **** ]

[ **** ]

[ **** ]

Changes to Subcontract:

     See attached Pages 1 — 19

	 	 	 	 	 
	ACAMBIS, INC	 	
CHESAPEAKE BIOLOGICAL LABORATORIES, INC
	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	
	 	

	 	 
	[ **** ]	 	
[ **** ]	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	December 31, 2002	 	
December 30, 2002	 	 

2

 

Section B

	1.	 	Delete Items 0001A, 0002, 004A, 005A, 006
	 
	 	 	Substitute:
	 
	B.1	 	 SUBCONTRACT LINE ITEM 0001A

Vaccine for Use as an Investigational New Drug (“IND”)

US Government ACAM 2000 Program

	 	 	 	 	 	 	 
	 	 	 	 	Estimated
	 	 	 	 	

	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	
	 	
	 	
	 	

	Fill, Lyophilize,
Finish and Perform
Specified Quality Control
Tests For Vaccinia (ACAM2000)
IND Vaccine as Described
In the Vaccine Statement of Work	 	
See Table 1
for per vial
charge and
Supplemental
Payment for 3rd
Fills
	 	[ **** ]
	 	[ ****
]
 
+
 
[ **** ]

SUBCONTRACT LINE ITEM 0001B

Change-over of Manufacturing Facilities

	 	 	 	 	 	 	 
	Description	 	Firm Fixed Price	 	Quantity
	
	 	
	 	

	Perform All Activities
Required to Clean Up
Facility After Filling
ACAM 2000	 	
*NSP
	 	 	1	 

	*	 	The change-over fee for Item 0001B is included in the “per vial”
price for
Item 0001A.

	B.2	 	 SUBCONTRACT LINE ITEM 0002

Manufacturing Time to Fill, Lyophilize, and Finish Vaccinia IND Vaccine(s)

	 	 	 	 	 	 	 
	 	 	 	 	Quantity	 	 
	Description	 	Firm Fixed Price	 	(months)	 	Total Amount
	
	 	
	 	
	 	

	Manufacturing Time
to Fill, Lyophilize,
Finish and Perform
Specified Quality Control
Tests For Vaccinia IND
Vaccine as Described
In the Vaccine Statement of Work	 	
See Paragraphs
B.2(a) & (b)
below
	 	See Paragraph
F.2 (Period of
Performance)
	 	As Ordered

	 	(a)	 	For manufacturing time utilized to fill and
finish ACAM 1000 vaccine under Item 0002, the price shall be [
**** ] per vial (utilization of Item 0002 for filling and
finishing ACAM 1000 vaccine is subject to Government
approval).
	 
	 	(b)	 	For manufacturing time utilized to fill and
finish ACAM 2000 vaccine under Item 0002, the price shall be
as set forth in Table 1 below.

3

 

	 	(c)	 	See Section H.4 regarding guaranteed payment
terms.

Table 1

	 	 	 	 	 
	Price per Vials	 	 	 	 
	For Items	 	Cumulative Number of Vials of ACAM 2000 Ordered by Buyer
	0001 & 0002*	 	Under Items 0001A & 0002
	
	 	

	[ **** ]
	 	 	[ **** ]	 
	[ **** ]
	 	 	[ **** ]	 
	[ **** ]
	 	 	[ **** ]	 
	[ **** ]
	 	 	[ **** ]	 
	[ **** ]
	 	 	[ **** ]	 

	*	 	Plus [ **** ] supplemental payment for each [ **** ]
(applicable
to Item 0001A only) (See Provision H.3.1)

	B.4	 	 SUBCONTRACT LINE ITEM 0004A (Indefinite Delivery/Indefinite Quantity)

Diluent to Accompany ACAM 1000 IND Vaccine

	 	 	 	 	 	 	 
	 	 	 	 	Estimated	 	Estimated
	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	
	 	
	 	
	 	

	Manufacture, Fill,
Finish, and Perform
Quality Control Tests
for Diluent as Described
in the Diluent Statement of Work	 	
[ **** ]
	 	[ **** ]
	 	[ **** ]

	 	(a)	 	Orders under Item 0004A are subject to Government
approval.
	 
	 	(b)	 	See Section G.2 for ordering provisions.

4

 

	B.5	 	 SUBCONTRACT LINE ITEM 0005A (Indefinite Delivery/Indefinite Quantity)

Approved Vaccine (after receipt of Biologics License)

	 	 	 	 	 	 	 
	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	
	 	
	 	
	 	

	Fill, Lyophilize,
Finish and Perform
Specified Quality Control
Tests For Licensed ACAM
1000 or 2000 Vaccine as
Described In Statement of
Work	 	
[ **** ]
	 	(Vials

as Ordered)
	 	(As Ordered)

	 	(a)	 	The estimated quantity is [ **** ] vials of
vaccine. This is Buyer’s current best estimate of the
quantities that may be ordered. The actual amounts ordered
may be more or less.
	 
	 	(b)	 	See Section G.2 for ordering provisions.

	B.6	 	 SUBCONTRACT LINE ITEM 0006 (Indefinite Delivery/Indefinite Quantity)

Diluent to Accompany Approved Vaccinia Vaccine(s)

(after receipt of Biologics License)

	 	 	 	 	 	 	 
	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	
	 	
	 	
	 	

	Manufacture, Fill,
Finish, and Perform
Quality Control Tests
For Diluent as Described
In Statement of Work	 	
[ **** ]
	 	(Vials as

Ordered)
	 	(As ordered)

	 	(a)	 	Estimated Quantity — The estimated quantity is[ **** ] vials
of diluent. This is Buyer’s current best estimate, but the number
ordered may be more or less.
	 
	 	(b)	 	See Section G.2 for ordering provisions.

	2.	 	Add Item 0008
	 
	B.8	 	 SUBCONTRACT LINE ITEM 0008

General Release (Section J, Attachment I)

	 	 	 
	Item 0008AA	 	Total Amount
	
	 	

	Reservation of Manufacturing	 	
[ **** ]
	Capacity in [ **** ]	 	 

	 	(a)	 	Buyer shall make payment for Item 0008AA within 10 calendar
days of receipt of invoice or January 20, 2003, whichever is later.

5

 

	 	 	 
	Item 0008AB	 	Total Amount
	
	 	

	All Other Aspects Covered by
the General Release Not Included
in Item 0008AA	 	
[ **** ]

	 	(a)	 	Buyer must make payment for Item 0008AB within 10 calendar days
of receipt of invoice or January 20, 2003, whichever is later.

Section E

	1.	 	Delete Provision E.1
	 
	 	 	Substitute:

	 	E.1	 	 INSPECTION, QUALITY ASSURANCE, 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) at the destination of the
articles, services or documentation.
	 
	 	(b)	 	Each order tendered for acceptance shall include a
Certificate of Conformance (See Section J, Attachment F), properly
executed by the Manufacturer. A copy of the Certificate of
Conformance shall also be included with Manufacturer’s invoice
following Buyer’s inspection and acceptance of each order.
	 
	 	(c)	 	Approval of Manufacturer’s final batch records shall
constitute “acceptance.”
	 
	 	(d)	 	Buyer will accept delivered filled vials that conform to
Subcontract requirements. A filled vial shall be considered to
conform to Subcontract requirements if its manufacture conforms to
good manufacturing practices and does not materially deviate from
the approved Master Batch Records or standard operating procedures.
A “material deviation” is one that causes the product to fail to
meet the Buyer’s release criteria.
	 
	 	(e)	 	On site inspections of the physical plant may be conducted by
the Buyer, the Government and/or their duly authorized
representatives and other designated technical experts. Plant
inspection, at 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.
	 
	 	(f)	 	In addition to the inspections discussed above, Buyer may
conduct one full-scale GMP audit per year. Buyer may conduct
additional full-scale GMP audits if the parties mutually agree or in
the instance of a product failure, deviations from acceptable
production practices, or any other occurrence that calls the
product’s quality or integrity into question.
	 
	 	(g)	 	Manufacturer agrees to provide and maintain a quality control system
acceptable to Buyer and the Government and to provide access to
Manufacturer’s facilities at all reasonable times for surveillance
periodically by Buyer and authorized representatives of the
Government. Manufacturer agrees to include, and to require its
subcontractors to include, the substance of this paragraph,
including this sentence, in each of its subcontracts under this
Subcontract.

6

 

Section F

	1.	 	Delete Provision F.1(b)
	 
	 	 	Substitute:

	 	(b)	 	The Manufacturer shall deliver, within the time frames
specified, the Items set forth below.

	 	 	 	 	 
	No.	 	Description	 	Delivery Date
	
	 	
	 	

	1	 	
Vials of IND ACAM 2000 per Subcontract
Item 0001A
	 	As scheduled in
accordance with
provision H.5
	 	 	 	 	 
	2	 	
Change-over per Subcontract Item 0001B
	 	At the completion of
filling ACAM 2000
	 	 	 	 	 
	3	 	
Vials of IND ACAM 1000 and/or ACAM 2000
per Subcontract Item 0002
	 	As scheduled in
accordance with
provision H.5
	 	 	 	 	 
	4	 	
Change-over(s) per Subcontract Item 0003A
and/or 0003B
	 	At end of each Item
0002 product
campaign(s)
	 	 	 	 	 
	5	 	
Vials of IND Diluent to accompany ACAM
1000 vaccine per Subcontract Item 0004A
	 	Concurrent with
delivery of Item
0002 ACAM 1000
vaccine to which the
diluent relates or,
if no related
vaccine, as mutually
agreed between Buyer
and Manufacturer
prior to Issuance of
the Delivery Order.
	 	 	 	 	 
	6	 	
Vials of IND Diluent to accompany ACAM
2000 vaccine per Subcontract Item 0004B
	 	Concurrent with
delivery of Item
0002 ACAM 2000
vaccine to which the
diluent relates or,
if no related
vaccine, as mutually
agreed between Buyer
and Manufacturer
prior to issuance of
the Delivery Order.
	 	 	 	 	 
	7	 	
Vials of ACAM 1000 or 2000 per Subcontract
Item 0005A
	 	As agreed upon
between Buyer and
Manufacturer prior
to Issuance of the
Delivery Order.
	 	 	 	 	 
	8 	 	
Change-over(s) per Subcontract Item 0005B
	 	At end of Item 0005A
product campaign(s)
	 	 	 	 	 
	9	 	
Vials of Diluent per Subcontract Item 0006
	 	As agreed upon
between Buyer and
Manufacturer prior
to Issuance of the
Delivery Order.

7

 

	2.	 	Delete Provision F.2
	 
	 	 	Substitute:

     F.2   PERIOD OF PERFORMANCE

	 	(a)	 	The period of performance for this Subcontract will be from
Subcontract Award
until [ **** ]
	 
	 	(b)	 	The period of performance for:
	 
	 	 	 	[ **** ]
	 
	 	(c)	 	The period of performance for Items 0001B, 0003A, and 0003B
facility change-overs will not exceed 30 calendar days after
completion of prior vaccine campaign fill with the last of such
change overs being completed no later than thirty days after the
completion date for Item 0001A or Item 0002, whichever is later.
	 
	 	(d)	 	The period of performance for Items 0005A, 0005B, and 0006
will be negotiated with the Manufacturer prior to award of the
delivery order(s).
	 
	 	(e)	 	The actual period of performance for delivery orders may
extend beyond the Subcontract period of performance.

Section G

	1.	 	Delete Provision G.1
	 
	 	 	Substitute:

     G.1   INVOICE/VOUCHER SUBMISSION

	 	(1)	 	The Manufacturer shall submit an original and
four (4) copies of contract invoices to the following address:

	 	 	 
	 	 	
Acambis, Inc.
	 	 	
(Attn: Accounts Payable)
	 	 	
38 Sidney Street
	 	 	
Cambridge, MA. 02139

	 	(2)	 	The Manufacturer shall include the following
information with each invoice:

	 	 	 	 	 
	 	 	
i
	 	Manufacturer’s Name & Address;
	 	 	
ii
	 	Manufacturer’s Tax Identification Number (TIN);
	 	 	
iii
	 	Subcontract and Purchase Order Number;
	 	 	
iv
	 	Invoice Number;
	 	 	
v
	 	Invoice Date;
	 	 	
vi
	 	Contract Line Item Number (per
Section B) and Delivery Order Number Shown on each
Delivery Order;
	 	 	
vii
	 	Quantity, including (if applicable)
specifying the number of vials of vaccine and diluent
actually filled and delivered;

8

 

	 	 	 	 	 
	 	 	
viii
	 	Unit Price & Extended Amount for
each line item, including the Fixed Price Billed based
upon the actual number of vaccine and/or diluent vials
filled and delivered;
	 	 	
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
	 	A copy of the Certificate of
Conformance (See Section J, Attachment G) signed by the
Manufacturer for each batch of vaccine and/or diluent
tendered for acceptance or for change over of
manufacturing facility; and
	 	 	
xiii
	 	If the invoice includes an amount
due under Clauses H.3, H.3.1, H.4, or H.6 a description
and a calculation for such amount.

	 	 	 	(Any invoice submitted without required Certifications shall
be considered defective and returned to Manufacturer without
payment.)
	 
	 	(3)	 	Manufacturer may invoice twice monthly for
delivered and accepted products and related services. For
this purpose, products and related services are “delivered” if
the Manufacturer has completed the certificate of analysis and
the certificate of conformance and the filled vaccine and/or
diluent vials are available for pick up by Buyer’s designee.
Acceptance shall be evidenced by Buyer’s approval of the final
batch records.
	 
	 	(4)	 	Together with Manufacturer’s final invoice for
Subcontract Items,
	 
	 	 	 	Manufacturer shall submit a list of all property supplied to
Manufacturer as Buyer-furnished property and a certification
that all Buyer-furnished property has either been consumed as
an expendable materials in performance of the Subcontract or
returned to the Buyer.

	2.	 	Delete Provision G.2(f)
	 
	 	 	Substitute:

	 	(f)	 	Ordering Periods

	 	 	 
	 	 	
(i) Items 0003A and 0003B– From Contract Award until 30 days after
the completion date of Item 0001A or Item 0002, whichever is later.
	 	 	 
	 	 	
(ii) Items 0004A and 0004B — From Contract Award until [ **** ]
	 	 	 
	 	 	
(iii) Items 0005A and 0005B and 0006 – From Receipt of BLA until [
**** ]

9

 

Modification 0003

	3.	 	Delete Provision G.7
	 
	 	 	Substitute:

	 	 	G.7 BUYER’S OBLIGATION TO PAY

	 	 	Buyer agrees to make timely payment on the payment dates set forth in this
Agreement. In addition, unless the Subcontract specifies otherwise, Buyer
agrees to make payment within thirty (30) calendar days of receipt of a
properly submitted invoice or voucher.
	 
	 	 	Timely payment is essential to this Agreement. Should Buyer fail to pay a
proper invoice (including batch records that are accepted, approved, and
not disputed by the Buyer) within 30 days of receiving such invoice,
Manufacture shall provide notice of such non-payment to Buyer. Buyer’s
repeated failure to cure non-payments within 15 days of receiving notice
from the Buyer will be a material breach of the Agreement.

Section H

	1.	 	Delete Provision H.3
	 
	 	 	Substitute:

	 	 	H.3 MISSED FILL FEES (ITEM 0001A — IND ACAM 2000 VACCINE)

	 	(a)	 	Buyer shall provide the Manufacturer with sufficient bulk
vaccine product to perform the number of fills per week during the
Item 0001A period as shown in Section J, Attachment G.
	 
	 	(b)	 	Buyer will pay Manufacturer a “missed fill” fee of [ **** ]
	 
	 	(c)	 	If the Buyer fails to provide the Manufacturer sufficient
bulk vaccine product to enable the Manufacturer to fill [****] of the [ **** ] scheduled for any week, Buyer will pay
the Manufacturer [ **** ] for each of those two fills missed.
	 
	 	(d)	 	Manufacturer may invoice for the “missed fill” fee
(paragraphs (b) and (c)above) at the conclusion of each one-week
period (Monday through Sunday) during the Item 0001A period of
performance.

10

 

Modification 0003

	2.	 	Add Provision H.3.1

	 	 	H.3.1 MANUFACTURER’S COMMITMENT TO PERFORM SCHEDULED FILLS

	 	(a)	 	Missed Fills (Items 0001A and 0002)
	 
	 	 	 	[ **** ]
	 
	 	(b)	 	Supplemental Payment for [ **** ] Fills in a Week (Item 0001A)
	 
	 	 	 	[ **** ]

	3.	 	Delete Provision H.4
	 
	 	 	Substitute:

	 	 	H.4 GUARANTEED PAYMENT AND ADVANCE PAYMENTS (ITEM 0002 — IND ACAM
1000 VACCINE AND/OR IND ACAM 2000 VACCINE)
	 
	 	 	(a) Guaranteed Payment. [ **** ][ **** ].

	 	 	 	[ **** ]

	4.	 	Delete Provision H.5
	 
	 	 	Substitute:

	 	 	H.5 PLANNED DATES FOR VACCINE FILL, LYOPHILIZATION, FINISH, AND
CHANGEOVER

	 	(a)	 	For planning purposes, the anticipated dates for the fill,
lyophilization, and finish of ACAM 2000 under Item 0001A from [
**** ] to the completion of the Item 0001A period of performance
and fill of vaccinia vaccine under Item 0002 are attached. (see
Section J, Attachment G).
	 
	 	(b)	 	Buyer will provide Manufacturer notice of the tentative date
for shipment of bulk vaccine no later than fourteen (14) calendar
days prior to shipment and the actual planned date for shipment of
bulk vaccine to Manufacturer no later than seven (7) calendar days
prior to the anticipated shipment date. Manufacturer shall fill all
bulk vaccine as soon as reasonably practicable based on a fill
schedule of at least two completed fills per week.
	 
	 	(c)	 	Buyer will provide Manufacturer at least 20 days notice prior
to the initiation of any change-over under Items 0001B, 0003A,
0003B, and/or 0005B.

11

 

Modification 0003

	5.	 	Delete Provision H.6
	 
	 	 	Substitute:

	 	 	H.6 VALIDATION OF CONSISTENCY OF MANUFACTURE

	 	 	Manufacturer shall demonstrate consistency of its fill, finish and
lyophilization process by manufacturing three (3) consecutive consistency
lots of ACAM 2000 vaccine that conform to subcontract requirements.
Acambis will notify CBL, in advance but no later than [ **** ] , which
lots are intended as consistency lots. [ **** ].
	 
	6.	 	Add Provision H.6.1
	 
	 	 	[ **** ].
	 	 	[ **** ].

12

 

Modification 0003

	8.	 	Delete Provision H.17
	 
	 	 	Substitute:

	 	 	H. 17 GOVERNMENT PROPERTY/BUYER FURNISHED PROPERTY

	A.	 	Government Property
	 
	 	 	Manufacturer shall be responsible for the control and accountable record
keeping for all Government Property under this subcontract in accordance
with FAR Subpart 45.5 as supplemented by HHS Publication (OS) 74.115
entitled “Contractor’s Guide for Control of Government Property,” a copy
of which will be provided upon request. Similar controls and record
keeping procedures shall be used for any Buyer-furnished equipment as
well.
	 
	 	 	The Chief of Material Management Branch, PGO, Centers for Disease Control
and Prevention (CDC), is the Government’s Property Administrator for
government property accountable under this contract. The subcontract
Program Officer (or his duly authorized representative) shall be the
Buyer’s Property Administrator for any Government or Buyer-furnished
property under this subcontract. The Manufacturer agrees to furnish
information regarding the Government property (or any Buyer-furnished
property) under this contract 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 Buyer’s Property
Administrator before furnishing information to the Government
representative.
	 
	 	 	The following Government property shall be furnished to the Manufacturer
under this Subcontract. Such items shall be marked as U.S. Government
Property, with the Subcontract #200-2002-00012 (CBL), the Prime Contract
#200-2000-00001 (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 Manufacturer shall not be responsible for any loss, damage, or
destruction of the above Government property (hereafter referred to as
“loss”), except to the extent that such loss:

	 	(1)	 	has been insured by the Manufacturer, in which
case, provision H.I2 shall apply, or
	 
	 	(2)	 	such loss was the result of Manufacturer’s
negligence or failure to store or manufacture such vaccine in
accordance with Good Manufacturing Practices (GMP) and the
applicable batch records and subcontract requirements.

13

 

Modification 0003

	 	 	B. Buyer Furnished Property

	 	 	Buyer has provided Manufacturer with the property listed in Section J,
Attachment H to this Subcontract as Buyer-furnished property.
Manufacturer shall manage and administer such property in accordance with
the Government Property (Fixed Price Contracts) (Dec 1989) clause, FAR
52.245-2, as modified to properly reflect the parties to this
Subcontract. Buyer shall either mark all Buyer-furnished property as
property of Acambis Inc. provided under Subcontract 200-2002-00012(CBL)
or provide labels to Manufacturer for Manufacturer to label
Buyer-furnished property.
	 
	 	 	Upon Subcontract completion and prior to final payment for Subcontract
Items, Manufacturer shall return such Buyer-furnished property to the
Buyer with the insurance and shipment charges (external costs) pre-paid
and to be reimbursed by Acambis under this Subcontract.
	 
	9.	 	Delete Section J, List of Attachments
	 
	 	 	Substitute:
	 
	 	 	Section J – List of Attachments

	 	A	 	Vaccine and Diluent Statements of Work & Schedule A,
Agreement of Technical Responsibility
	 
	 	B	 	Confidentiality Agreement
	 
	 	C	 	CBL Security Plan (when submitted and approved after award)
	 
	 	D	 	Chesapeake Biological Laboratories Inc’s Representations,
Certifications and Other Statements of Offerors
	 
	 	E	 	Acambis Delivery Order (See Section G.1)
	 
	 	F	 	Certificate of Conformance (See Section G.1)
	 
	 	G	 	Item 0001A and 00002 Planned Vaccine Schedule
	 
	 	H	 	Buyer-furnished Property
	 
	 	I	 	Modification 0003 General Release

14

 

Modification 0003

	10.	 	Delete Section J, Attachment G
	 
	 	 	Substitute:

Section J, Attachment G

Subcontract 200-2002-00012 (CBL)

Acambis Prime Contractor

SCHEDULE

Item 0001A and 00002 Planned Vaccine Schedule

[ **** ]

ACAM 2000 (or ACAM 1000 with a change-over)

	 	 	 	 	 	 	 
	Week	 	Item Number	 	Number of Fills
	
	 	
	 	

	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]
	[ **** ]	 	[ **** ]	 	[ **** ]

15

 

Modification 0003

	11.	 	Delete Section J, Attachment H
	 
	 	 	Substitute:

Section J, Attachment H

Subcontract 200-2002-00012 (CBL)

Acambis Prime Contractor

BUYER-FURNISHED PROPERTY

A.     In accordance with Clause H.20, the Buyer has provided the following
equipment (to be returned upon Subcontract completion) to the Manufacturer “as
is” as Buyer-furnished property:

               [ **** ]

B.     In accordance with Clause H.17, the Buyer has provided the following
materials (to be consumed in performing the Subcontract) to the Manufacturer
“as is” as Buyer-furnished property:

          [ **** ]

16

 

Modification 0003

	12.	 	Delete Section J, Attachment I
	 
	 	 	Substitute:

Section J, Attachment I

Subcontract 200-2002-00012 (CBL)

Acambis Prime Contractor

SUBCONTRACT 200-2002-00012(CBL)

MODIFICATION 0003 GENERAL RELEASE

A.     In consideration of the mutual promises and agreements reached in this
Modification 0003, except as stated in paragraph (c) below, the Parties
mutually release and forever discharge each other from:

	 	 	1. any and all rights, known or unknown, arising under or relating to the
performance of this Subcontract (including the changes made in this
Subcontract modification) that the Parties may have against each other as
of the date of the first signature on this Modification 0003 with respect
to: (a) any rights to equitable adjustment or other relief to which a
Party may be entitled under the Subcontract provisions, (b) damages, (c)
interest, and (d) any other relief, claims, demands, and causes of action
to which a Party may be entitled at law or equity; and
	 
	 	 	2. any and all rights, known or unknown, the Parties may have to a price
adjustment as the result of any increased costs (including but not
limited to, costs resulting from delays, disruption, loss of efficiency
and/or impact costs, including cumulative impact costs) and associated
profit, including any anticipatory profit lost, and schedule adjustments
with respect to any and all matters arising under or relating to
Subcontract performance, including the changes made in this Subcontract
Modification 0003.

B.     Chesapeake Biological Laboratories (CBL) hereby cancels Invoice 8242,
thereby removing any liability for that invoice from Acambis Inc.

C.     The above general release shall not affect CBL’s right:

	 	 	1. to payment for any vaccine or diluent (items) delivered, but for which
the applicable batch records have not yet been approved, to the extent
that such items are determined to comply with Subcontract requirements;
and
	 
	 	 	2. to payment of pending invoices [ **** ] to the extent that such
invoices are proper and are determined to cover product and services that
comply with Subcontract requirements.

17

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