Document:

exv4w32

 

EXHIBIT 4.32

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.

Modification 0004

ACAMBIS SUBCONTRACT MODIFICATION 0004

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

Modification No.: 0004

Effective Date: December 20, 2002

	 	 	 	 	 
	Subcontractors:	 	
Baxter Healthcare SA

Hertistrasse 2

CH-8304 Wallisellen, Switzerland
	 	Baxter Healthcare Corporation

One Baxter Parkway

Deerfield, IL 60015

Description of Modification:

	 	 	 	Revises H.26 Provision for Services to Be Provided by Baxter Healthcare
SA in support of the development of ACAM2000 manufacturing processes and
subsequent manufacturing efforts.

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

Total Change to Subcontract value: $0.00 (No Change)

Changes to Subcontract:

	 	 	 	See attached Pages 2 and 3.

RELEASE OF CLAIMS

In consideration of the modifications made above, this Modification is in full
settlement of any right the Subcontractors may have to any equitable
adjustment(s) 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

 

 

Modification 0004

Section B

Delete Item 0007.

Substitute:

0007- AdditionalServices (See Provision H.26)

	 	 	 	 	 	 	 	 
	0007AA-	 	
Services in Support of Development

Of Manufacturing Process
	 	As Required
	[****]	 	[****]
	 	 	 	 	 	 	 	 
	0007AB-	 	
Services in Support of Manufacturing

Item 0001 Vaccine Kits
	 	As Required
	[****]	 	[****]
	 	 	 	 	 	 	 	 
	0007 AC	 	
Services in support of Manufacturing

Item 0002 Vaccine Kits
	 	As Required
	[****]	 	[****]

Section C

Add:

Item 0007—Services in Support of Development of Manufacturing Process and
Manufacturing, as described in Provision H.26

Section F

Add:

	 	 	 	 	 	 	 
	0007AA	 	
Additional Services
to Develop
Manufacturing Process
	 	As Required
	 	[ **** ]
	 	 	 	 	 	 	 
	0007AB	 	
Services in Support
of Manufacturing
	 	As Required
	 	Until Government
Acceptance of Item
0001 Vaccine Kits
Ordered
	 	 	 	 	 	 	 
	0007 AC	 	
Services in Support
of Manufacturing
	 	As Required
	 	Until Government
Acceptance of Item
0002 Vaccine Kits
Ordered

2

 

Modification 0004

Section H

     Delete H.26.

Substitute:

H.26 PAYMENT FOR ADDITIONAL SERVICES (ITEM 0007)

Contractor shall pay 1st Subcontractor:

	 	a.	 	[ **** ] for services provided in support of the development of
the ACAM2000 vaccine kit manufacturing process. The 1st Subcontractor
may invoice for such services upon completion of such efforts ([ ****
] ). Payment for Item 0007AA services performed shall be due and
payable within thirty (30) days after receipt of a proper invoice or on
March 31, 2003, whichever is later, without regard to whether the
Contractor has received payment from the US Government for any vaccine
kits manufactured under this subcontract. (Item 0007AA)
	 
	 	b.	 	[ **** ] for services rendered to assist in the manufacture of
Item 0001 kitted vaccine. The 1st Subcontractor may invoice the
Contractor for such services upon the delivery and Government
acceptance of the last of the initial 1.55 million vaccine kits ordered
under Item 0001 of this subcontract (completion and Government
acceptance of the 155 million dose order). Such invoice shall be
payable by the Contractor within thirty (30) days after receipt of a
proper invoice or Contractor receipt of final payment from the US
Government for the last of the 1.55 million vaccine kits delivered and
accepted, whichever is later. (Item 0007AB)
	 
	 	c.	 	[ **** ] for kitted smallpox vaccine ordered under Section B,
Item 0002 of this subcontract. The 1st Subcontractor shall submit an
invoice for additional services under ITEM 0007AC at the same time
invoices are submitted for completed kits delivered under ITEM 0002.
Payment for ITEM 0007AC shall be due at the same time payment is due
for kitted vaccine under ITEM 0002. (Item 0007AC)
	 
	 	d.	 	The additional services contemplated by this provision include:
reasonable technical and consulting assistance and services regarding
export/import assistance, technical and quality issues, and assistance
concerning Contractor’s Security Plan with respect to facilities and
vaccine transportation security after purification at Contractor’s
facilities.

3exv4w33

 

EXHIBIT 4.33

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.

Modification 0004

ACAMBIS SUBCONTRACT MODIFICATION 0005

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

Modification No.: 0005

Effective Date: May 29, 2003

	 	 	 	 	 
	Subcontractors:	 	
Baxter Healthcare SA

Hertistrasse 2

CH-8304 Wallisellen, Switzerland
	 	Baxter Healthcare Corporation

One Baxter Parkway

Deerfield, IL 60015

Description of Modification:

	 	(A)	 	Adds testing for Detection of Vero Cell DNA being an impurity
in an estimated quantity sufficient to provide the US Government
with up to [ **** ] doses of ACAM 2000.
	 
	 	(B)	 	Changes the Contractor’s Property Administrator in Clause H.14

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

Estimated Total Change to Subcontract value: $[ **** ]

Changes to Subcontract:

	 	 	 	See attached Pages 2 and 3.

RELEASE OF CLAIMS

In consideration of the modifications made above, this Modification is in full
settlement of any right the Subcontractors may have to any equitable
adjustment(s) 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 May 29, 2003
	 	Execution Date      , 2003

 

 

Modification 0005

Section B — Schedule of Subcontract ITEMs/Prices

Add:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	Estimated	 	Unit	 	Estimated
	Item	 	Description	 	Quantity	 	Price	 	Total Amount
	
	 	
	 	
	 	
	 	

	Item 0008	 	Testing for Vero Cell

DNA Being an Impurity
	 	[****]	 	 	[****]	 	 	 	[****]

	*	 	1st Subcontractor shall perform testing for Vero Cell DNA being
an impurity in provided samples as requested by the Contractor.
The Contractor shall request testing by submitting an ACAM2000
testing sample and a description of the testing required to the
1st Subcontractor. The estimated maximum number of tests that may
be ordered is [ **** ] but the number of tests required may be
more or less depending on various factors. Contractor shall have
no liability for payment except to the extent that testing is
requested. 1st Subcontractor shall be required to perform DNA
testing, if requested, only to the extent that such vaccine was
purchased from the 1st Subcontractor under the terms of this
Subcontract.

Section C — Description/Specification/Work Statement

Add:

ITEM 0008 –Testing for Vero Cell DNA

1st Subcontractor shall perform testing of ACAM 2000 samples for Vero Cell DNA
being an impurity in provided samples in accordance with Protocol IQ9032, cGMP
controls appropriate to a lab that supports cGMP manufacturing, relevant
regulations, and due care and attention.

1st Subcontractor shall supply a Test Report on completion of each test for
Vero Cell DNA being an impurity in the provided samples. The Test Report shall
indicate the methods, results, observations and conclusions derived from the
test identified in the protocol. 1st Subcontractor shall make all reasonable
efforts to issue the Test Report within 21 days from receipt of the ACAM 2000
sample sent for testing.

Section E — Inspection and Acceptance

Add:

E.1A 0008 – Testing for Vero Cell DNA being an impurity shall be accepted upon
Contractor’s receipt of a Test Report (see Section C, Item 0008 for the
description of the Test Report) indicating that the test was performed in
accordance with the requirements of this Subcontract.

Section F — Deliveries or Performance

Add:

	 	 	 	 	 	 	 
	 	 	ITEM	 	Quantity	 	Deliver
	 	 	
	 	
	 	

	F.1(4)	 	
Item 0008 Test Report
	 	1 Test Report

Per Test Ordered
	 	Use all reasonable
efforts to deliver
within 21 days of
receipt of the ACAM
2000 sample for
testing

2

 

Modification 0005

Section G — Subcontract Administration Data

Add:

	G.1(2)(xiv)	 	 For Item 0008, the invoice must include the quantity of the tests
invoiced and the lot number for the sample related to each of those tests.

Section H — Special Subcontract Requirements

Delete Entire Provision:

H.14 GOVERNMENT PROPERTY/CONTRACTOR FURNISHED PROPERTY

Substitute:

H.14 GOVERNMENT PROPERTY/CONTRACTOR FURNISHED PROPERTY

	 	 	 	Each Subcontractor shall be responsible for the control and accountable
record keeping for all Government Property in their possession under this
subcontract in accordance with FAR Subpart 45.5 as supplemented by DHHS
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
Contractor-furnished property as well.
	 
	 	 	 	The Chief of Material Management Branch, PGO, CDC, is the Government’s
Property Administrator for government property accountable under this
Subcontract. The Contractor’s Property Administrator for any Government
or Contractor-furnished property under this Subcontract is [
**** ].
The Subcontractor agrees to furnish information regarding the Government
property (or any Contractor-furnished property) under this Subcontract to
the respective Property Administrator, an authorized representative, or a
duly designated successor(s). Any inquiry from or information proposed to
be furnished to the Government Property Administrator shall be promptly
reported to Contractor’s Property Administrator before furnishing
information to the Government representative.
	 
	 	 	 	The following Government property shall be furnished to the specified
Subcontractor under this Subcontract. Such items shall be marked as U.S.
Government Property, with the Subcontract # 200-2002-0001(BXTR), the
Prime Contract #200-2002-00004 (Acambis Inc, Prime Contractor) (if not
already so marked when received) and shall be managed and administered
while in Subcontractors’ possession in accordance with the Government
Property (Fixed Price Contracts) (Dec 1989) clause, FAR 52.245.2:

	 	1.	 	Two (2) 9 mL vials of master virus seed (as is)
[ **** ] ); and
	 
	 	2.	 	[ **** ]

	 	 	 	Contractor shall furnish the following materials in sufficient quantities
to enable the 2nd Subcontractor to assemble the number of smallpox
vaccine kits ordered, in accordance with the Government Property (Fixed
Price Contracts) (Dec 1989) clause, FAR 52.245.2, modified to properly
reflect the parties, and marked to identify as the property as property
of Acambis Inc. (“Contractor Furnished Property”):

	 	 	 	[ **** ]

3

 

Modification 0005

Add:

H.30 Quality Control Testing Services (Item 0008)

	(a)	 	In the event that 1st Subcontractor should deem it advisable or necessary
to make variations to the agreed upon testing protocol, Contractor shall
be notified of such variation at least 14 days in advance of the first
planned use of the revised protocol and be given opportunity to comment on
the proposed variation. Contractor may request a change to the testing
protocol by writing to 1st Subcontractor (Attn: [ **** ] ). 1st
Subcontractor shall not be obligated to implement any variations or
deviations to the protocol requested by Contractor if such implementation
would result or would likely result in a breach of GMP or any other
relevant regulations, or if such implementation would not be commercially
reasonable..
	 
	(b)	 	If a repeat of a test is required, 1st Subcontractor shall carry out such
repeat test as soon as reasonably practicable and at 1st Subcontractor’s
sole cost provided the requirement to repeat is caused by 1st
Subcontractor’s wrongful act or omission. If the repeat test is due to
Contractor’s wrongful act or omission, Contractor shall pay the price
listed in Item 0008 for the repeat test. Acambis shall make available to
1st Subcontractor sufficient quantities of ACAM 2000 to enable the 1st
Subcontractor to perform the test and to repeat the test in the event of
loss or damage to the material prior to the completion of the test or in
the event that any part of the test must be repeated.
	 
	(c)	 	If Contractor requests that the 1st Subcontractor send test samples or
other material to the Contractor during or following completion of a test,
Contractor shall be responsible for all the transportation and insurance
costs for sending that sample or material.
	 
	(d)	 	For no less than the period required under GMP and any other relevant
regulations, 1st Subcontractor shall store or shall arrange to be stored
all data, information, results, material and other documentation relating
to the testing services provided under Item 0008 of this Subcontract.

4

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