Document:

exv4w34

 

Exhibit 4.34

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.

SUBCONTRACT

Section A – Subcontract Form

	 	 	 
	Subcontract between:	 	
Subcontract No: 200-2002-00012(CBL)
	Acambis, Inc.	 	
Prime Contracts Nos: 200-2002-00004 &
	38 Sidney Street	 	
200-2000-00001
	Cambridge, MA 02139	 	
Contractual Officer: [ **** ]
	 	 	
Program Officer: [ **** ]
	 	 	 
	AND	 	 
	 	 	 
	Chesapeake Biological Laboratories, Inc.	 	 
	1111 S. Paca Street	 	 
	Baltimore, MD 21230-2591	 	 

     This Subcontract is entered into effective this 30th day of April, 2002,
between Acambis, Inc., 38 Sidney Street, Cambridge, MA 02139 (hereinafter
“Buyer”) and Chesapeake Biological Laboratories, Inc. (hereinafter
“Manufacturer”).

     In consideration of the mutual promises, covenants and agreements set
forth herein, the parties agree that the Manufacturer shall furnish and deliver
to the Buyer all the supplies and perform all the services set forth in this
Subcontract, for the consideration stated herein. The rights and obligations
of the parties to this Subcontract shall be subject to and governed by this
Subcontract and other documents attached hereto or explicitly referenced
herein.

     This Subcontract sets forth the entire agreement of the parties and
supersedes any and all prior agreements of the parties, whether oral or
written, concerning the subject matter hereof. Neither party relied on any
representations, whether oral or written, in entering into this Subcontract
that are not incorporated into this Subcontract.

     This Subcontract shall not be varied or changed in its terms or conditions
by any oral agreement or representation. This Subcontract may be modified only
by a written instrument properly executed by one with authority on or after the
date hereof.

     The article titles used herein are for convenience only and shall in no
way be construed as part of this Subcontract, or as an indication of the
meaning of a particular section.

     IN WITNESS WHEREOF, the parties hereto have executed this Subcontract to
be effective as of the day and year first above written.

	 	 	 	 	 	 	 	 	 
	ACAMBIS INC.	 	CHESAPEAKE BIOLOGICAL LABORATORIES INC.	 	 
	 	 	 	 	 	 	 	 	 
	By:	 	 	 	By:	 	 	 	 
	 	 	

	 	 	 	
	 	 
	Name:	 	
[ **** ]
	 	Name:
	 	[ **** ]	 	 
	Title:	 	
[ **** ]
	 	Title:
	 	[ **** ]	 	 
	Date:	 	
May 1, 2002
	 	Date:
	 	4/29/02	 	 

 

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

Section B — Supplies Or Services and Prices/Costs

	 	 	 
	B.1	 	
SUBCONTRACT LINE ITEM 0001A
	 	 	
Vaccine for Use as an Investigational New Drug (“IND”)
	 	 	
US Government ACAM 2000 Program

	 	 	 	 	 	 	 	 	 
	 	 	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	 	 	
	 	
	 	
	 	

	 	 	
Fill, Lyophilize,
	 	See Table 1
	 	[ **** ]
	 	[ **** ]
	 	 	
Finish and Perform
	 	vials	 	 	 	 
	 	 	
Specified Quality Control	 	 	 	 	 	 
	 	 	
Tests For Vaccinia (ACAM2000)	 	 	 	 	 	 
	 	 	
IND Vaccine as Described	 	 	 	 	 	 
	 	 	
In the Vaccine Statement of Work	 	 	 	 	 	 

	 	 	 
	 	 	
SUBCONTRACT LINE ITEM 0001B
	 	 	
Change-over of Manufacturing Facilities

	 	 	 	 	 	 	 	 	 
	 	 	Description	 	Firm Fixed Price	 	Quantity
	 	 	
	 	
	 	

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

		
	 	     * 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)

	 	 	 	 	 	 	 	 	 
	 	 	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	 	 	
	 	
	 	
	 	

	 	 	
Manufacturing Time
	 	See Paragraphs
	 	[ **** ]
	 	[ **** ]
	 	 	
to Fill, Lyophilize,
	 	B.2(a) & (b)	 	 	 	 
	 	 	
Finish and Perform
	 	below	 	 	 	 
	 	 	
Specified Quality Control	 	 	 	 	 	 
	 	 	
Tests For Vaccinia IND	 	 	 	 	 	 
	 	 	
Vaccine as Described	 	 	 	 	 	 
	 	 	
In the Vaccine Statement of Work	 	 	 	 	 	 

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

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ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

Table 1

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

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

	 	 	 
	B.3	 	
SUBCONTRACT LINE ITEM 0003A (Indefinite Delivery/Indefinite Quantity)
	 	 	
Change-over of Manufacturing Facilities After Filling ACAM 1000

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Estimated	 	Estimated
	 	 	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	 	 	
	 	
	 	
	 	

	 	 	
Perform All Activities
	 	[ **** ]
	 	[ **** ]
	 	[ **** ]
	 	 	
Required to Clean Up	 	 	 	 	 	 
	 	 	
Facility After Filling	 	 	 	 	 	 
	 	 	
ACAM 1000 Vaccine	 	 	 	 	 	 
	 	 	
Under Item 0002	 	 	 	 	 	 

	 	 	 	 	 
	 	 	
(a)
	 	Order of change-over under Item 0003A
is subject to Government approval.
	 	 	 	 	 
	 	 	
(b)
	 	See Section G.2 for ordering provisions.

	 	 	 
	 	 	
SUBCONTRACT LINE ITEM 0003B (Indefinite Delivery/Indefinite Quantity)
Change-over of Manufacturing Facilities After Filling ACAM 2000

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Estimated	 	Estimated
	 	 	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	 	 	
	 	
	 	
	 	

	 	 	
Perform all Activities
	 	[ **** ]
	 	[ **** ]
	 	[ **** ]
	 	 	
Required to Clean Up	 	 	 	 	 	 
	 	 	
Facility After Filling	 	 	 	 	 	 
	 	 	
ACAM 2000 Vaccine	 	 	 	 	 	 
	 	 	
Under Item 0002	 	 	 	 	 	 

	 	 	 	 	 
	 	 	
(a)
	 	See Section G.2 for ordering provisions

	 	 	 
	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.

3

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

	 	 	 	 	 
	 	 	
(b)
	 	See Section G.2 for ordering provisions.

	 	 	 
	 	 	
SUBCONTRACT LINE ITEM 0004B (Indefinite Delivery/Indefinite Quantity)
	 	 	
Diluent to Accompany ACAM 2000 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)
	 	See Section G.2 for ordering provisions.

	 	 	 
	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,
	 	$ [per vial price
	 	(As Ordered)
	 	(As Ordered)
	 	 	
Finish and Perform
	 	to be mutually	 	 	 	 
	 	 	
Specified Quality Control
	 	agreed to prior	 	 	 	 
	 	 	
Tests For Licensed ACAM
	 	to issuance of	 	 	 	 
	 	 	
1000 or 2000 Vaccine as
	 	any order]	 	 	 	 
	 	 	
Described In Statement of	 	 	 	 	 	 
	 	 	
Work	 	 	 	 	 	 

	 	 	 	 	 
	 	 	
(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.

	 	 	 
	 	 	
SUBCONTRACT LINE ITEM 0005B (Indefinite Delivery/Indefinite Quantity)
	 	 	
Change-over of Manufacturing Facilities (After Manufacture of 0005A Orders)

	 	 	 	 	 	 	 	 	 
	 	 	Description	 	Firm Fixed Price	 	Quantity	 	Total Amount
	 	 	
	 	
	 	
	 	

	 	 	
Perform All Activities
	 	$[to be mutually
	 	(As Ordered)
	 	(As Ordered)
	 	 	
Required to Clean Up
	 	agreed to prior to	 	 	 	 
	 	 	
Facility After Filling
	 	issuance of any	 	 	 	 
	 	 	
ACAM 1000 or 2000
	 	order]	 	 	 	 

	 	 	 	 	 
	 	 	
(a)
	 	The estimated quantity is 2 change-overs. 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

4

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

	 	 	 
	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,
	 	$[per vial price
	 	(As ordered)
	 	(As ordered)
	 	 	
Finish, and Perform
	 	to be mutually	 	 	 	 
	 	 	
Quality Control Tests
	 	agreed to prior	 	 	 	 
	 	 	
For Diluent as Described
	 	to issuance of	 	 	 	 
	 	 	
In Statement of Work
	 	any order]	 	 	 	 

	 	 	 	 	 
	 	 	
(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.

	 	 	 
	B.7	 	
SUBCONTRACT LINE ITEM 0007

	 	 	 	 	 
	 	 	Description	 	Price
	 	 	
	 	

	 	 	
Data for Assembly
	 	Not separately
	 	 	
and Filing of the BLA
	 	Priced

5

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

Section C — Description/Specification/Work Statement

	 	 	 
	C.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
(Prime Contract 200-2002-00004) to develop,
license, and manufacture a stockpile (estimated
155 million doses) of a new vaccine (ACAM 2000)
within the shortest time possible. DHHS/CDC
has also awarded Acambis Inc. a contract (Prime
Contract 200-2001-00001) to develop, license,
and manufacture a stockpile of approximately 54
million doses of a new vaccine (ACAM 1000) as
soon as possible.
	 	 	 	 	 
	C.2	 	
PURPOSE
	 	 	 	 	 
	 	 	
The purpose of this Subcontract is to assist the Manufacturer in
providing 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 Subcontract.
	 	 	 	 	 
	 	 	 	 	 
	C.3	 	
SCOPE OF WORK:
	 	 	 	 	 
	 	 	
The Manufacturer, as an independent organization and not as an agent of
the Buyer, shall furnish all labor, materials, supplies, facilities,
equipment, transportation and travel required to: (1) fill, lyophilize,
and finish Vaccinia vaccine produced in bulk by Manufacturer and perform
certain quality control tests on such vaccine; (2) manufacture, fill, and
finish diluent and perform certain quality control tests on such diluent;
and (3) provide documentation and records to assist Buyer in submitting a
Biologics License Application (“BLA”). All activities shall be done in
accordance with cGMP.
	 	 	 	 	 
	C.4	 	
SPECIFIC TECHNICAL REQUIREMENTS
	 	 	 	 	 
	 	 	
a. The Manufacturer shall perform these Subcontract tasks in accordance
with the Statements of Work (“SOW”) attached hereto at Section J,
Attachment A:
	 	 	 	 	 
	 	 	
b. Shipping. See F.1 and F.4. for Shipping/Delivery requirements.
	 	 	 	 	 
	C.5	 	
EMERGENCY CONTACTS
	 	 	 	 	 
	 	 	
The Manufacturer shall provide a point of contact that will be available
24 hours per day, seven days per week.
	 	 	 	 	 
	C.6	 	
REPORTING REQUIREMENTS
	 	 	 	 	 
	 	 	
The Manufacturer shall submit Monthly and Quarterly Progress Reports.
The progress Reports shall include the information listed below that is
applicable for the performance period during the period being reported.
The Manufacturer shall submit one copy of each Progress Report
electronically via e-mail. Any attachments to the e-mail report shall be
submitted in Microsoft Word.

	 	 	 	 	 	 	 
	 	 	 	
1.	 	 	Monthly Reports

	 	 	 	 	 
	 	 	
a.
	 	Listing of all manufacturing events during the
preceding month, showing start dates, expected end dates,
number of vials of vaccine and diluent produced, inventoried,

6

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

	 	 	 	 	 
	 	 	 	 	and shipped/picked-up. An explanation of any problems
encountered, delays, and recommendations will be provided.
An appendix shall also be provided setting forth the full
technical specifications for each manufacturing event
initiated during the month; and
	 	 	
b.
	 	Listing of all quality control testing begun
and/or completed during the preceding month, showing start
dates, expected end dates, and results of such tests for both
vaccine and diluent.

	 	 	 	 	 	 	 
	 	 	 	
2.	 	 	Quarterly Reports

	 	 	 	 	 
	 	 	
a.
	 	Listing of all manufacturing events anticipated during the next quarter;
	 	 	
b.
	 	FDA inspections and consultation results or recommendation; and
	 	 	
c.
	 	Security assessment, problems and recommendations.

	 	 	 	 	 	 	 
	 	 	 	
3.	 	 	See Section F, Paragraph F.1 for additional reports and data requirements.

7

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

Section D — Packaging and Marking

	 	 	 	 	 
	 	 	
(a)
	 	Packaging shall conform to instructions provided by Buyer
through the Buyer’s validated packaging and shipping protocol to
ensure acceptance by common carrier or Buyer’s designee for safe
delivery to destination.
	 	 	 	 	 
	 	 	
(b)
	 	All shipping/mailing containers shall be marked showing the
Subcontract Number and Contract Number and shall be marked clearly
as refrigerated and/or frozen items (as required).
	 	 	 	 	 
	 	 	
(c)
	 	Exterior of shipping containers of ACAM 1000 vaccine
delivered under Item 0002 and ITEM 004A diluent shall be marked
[ **** ].

8

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

Section E – Inspection, Quality Assurance, and Acceptance

     The following FAR clauses are incorporated herein by reference.
References to the “Government” shall be deemed to refer to the Buyer as
described in Section I.1.

	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.246-4	 	
Inspection of Services-Fixed Price (Aug 1996)
	52.246-2	 	
Inspection of Supplies-Fixed Price (Aug 1996)
	52.246-16	 	
Responsibility for Supplies (Apr 1984)

	 	 	 
	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)
	 	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.
	 	 	 	 	 
	 	 	
(d)
	 	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.
	 	 	 	 	 
	 	 	
(e)
	 	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.

	 	 	 
	E.2	 	
RESEARCH RECORDS, INSPECTION AND CONSULTATION

	 	 	 	 	 
	 	 	
(a)
	 	The Manufacturer agrees to maintain books, records, and
supporting documentation in such detail as will properly reflect all
work done and results achieved in the performance of this
Subcontract, and agrees to retain and preserve the same, together
with all research notes, charts, graphs, comments, computations,
analysis, and other graphic or written data generated in connection
with performance hereunder and agrees to permit the Contractual
Officer or his authorized representatives to examine and review the
same at all reasonable times during said period. Buyer shall have
the right to copy such

9

 

ACAMBIS CONFIDENTIAL  —  PROPRIETARY INFORMATION

	 	 	 	 	 
	 	 	 	 	documentation at Manufacturer’s facility and to retain such copies
for Buyer’s records. Additionally, Manufacturer shall not destroy
or dispose of such documents; but shall furnish the originals and
existing copies of such documentation to Acambis Inc. upon
Subcontract completion.
	 	 	 	 	 
	 	 	
(b)
	 	The Contractual Officer or any of his authorized
representatives shall have the right to inspect the work of the
Manufacturer and subcontractors, if any, and the plant, floor plans,
equipment validation, and any other production information necessary
to ensure the safety, purity, and potency of the product, including
laboratories, shops, offices, or other premises where the work is
being performed. The Manufacturer shall provide and shall require
his subcontractors to provide all reasonable facilities and
assistance for the safety and convenience of such representatives in
the performance of their duties. Personnel engaged in the
performance of the Subcontract shall be available at all reasonable
times for consultation with such representatives. All inspections
and review shall be performed in such a manner as will not unduly
delay or interfere with the work.
	 	 	 	 	 
	 	 	
(c)
	 	Additionally, the Manufacturer shall inform the Buyer, in
writing, of any deviations, complaints, and adverse events, as well
as the results of all tests and investigations regarding or possibly
impacting the product. Manufacturer shall also inform Buyer of any
proposed changes to Manufacturer’s production and facilities used in
support of this Subcontract prior to implementation (including
introduction of new products or clinical material processing
operations within the Manufacturer’s viral manufacturing facility)
(see, e.g., 21 CFR 601.12).

10

 

`
ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

Section F – Deliveries or Performance

          The following FAR clauses are incorporated herein by reference.
References to the “Government” shall be deemed to refer to the Buyer as
described in Section I.1.

	 	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.242-15	 	
Stop Work Order (Aug 1989)
	52.242-17	 	
Government Delay of Work (Apr 1984)

	F.1	 	DELIVERABLE(S) SCHEDULE

	 	(a)	 	The Manufacturer shall deliver, within the time frames
specified, the Items set forth below, to the Contractual Officer at
the address shown in Section G.

	 	 	 	 	 	 	 	 	 
	Item No.	 	Description	 	No. of	 	Delivery Date
	 	 	 	 	Copies	 	 
	1	 	
Monthly Progress
Report (Section
C-Item C.6)
	 	 	1	 	 	On or before the
first work day of
each month
beginning the first
full month after
Subcontract award
	2	 	
Quarterly Progress
Report (Section
C-Item C.6)
	 	 	1	 	 	On or before
January 2, April 2,
July 2, and October
2 of each year
	3	 	
Draft Security Plan

(Section H-Item H-13)
	 	 	2	 	 	30 Calendar Days
After Award of the
Subcontract
	4	 	
Final Security Plan

(Section H-Item H-13)
	 	 	2	 	 	10 Calendar Days
After Receipt of
Comments
	5	 	
Reports and Data
	 	 	As required	 	 	As specified

11

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	(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 end of Item
0001A product
campaign
	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
	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.

12

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	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 [ **** ].
	 
	 	(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.

	F.3	 	PLACE(S) OF PERFORMANCE
	 
	 	 	The Manufacturer shall perform the work under this Subcontract at the location specified below:

	 	 	 	[ **** ]

	F.4	 	SHIPPING/DELIVERY REQUIREMENTS
	 
	 	 	Acambis or its designee (as specified in the delivery order) will
arrange for shipment of released product from CBL, with pick up from CBL’s
loading dock at a mutually agreeable time.

13

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

Section G – Contract Administration Data

	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;
	 
	 	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.	 	Quantity of the General Safety and
Microbial Limits Tests conducted in accordance with the
Statement of Work (see Section B.2(c)) (if applicable);
	 
	 	x.	 	Total Amount of Invoice;
	 
	 	xi.	 	Name, title and telephone number of
person to be notified in the event of a defective
invoice;
	 
	 	xii.	 	Payment address, if different from the information in (2)i. Above;
	 
	 	xiii.	 	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
	 
	 	xiv.	 	If the invoice includes an amount due
under Clauses H.3, 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 and
accepted” 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.

	G.2	 	ISSUANCE OF DELIVERY ORDERS

	 	(a)	 	Orders may be issued against Contract Line Items 0004A,
0004B, 0005A, 0005B and 0006 to fill and finish vaccine and/or
diluent and Items 0003A, 0003B and 0005B to

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	 	 	change over the manufacturing facility at the price(s) set forth in
the Subcontract Schedule (Section B).
	 
	 	(b)	 	Such orders shall be effective upon receipt by the
Manufacturer and shall be issued either in writing or by electronic
message to be confirmed in writing within five (5) business days of
issuance. Each order shall contain the following information (as
applicable):

	 	(1)	 	The Delivery Order Number;
	 
	 	(2)	 	The Contract Line Item (0003A, 0003B,
0004A, 0004B, 0005A, 0005B, or 0006) against which the
order is being placed;
	 
	 	(3)	 	The estimated quantity of bulk
vaccine to be filled and finished or of diluent to be
manufactured, filled and finished under the delivery
order (if applicable)
	 
	 	(4)	 	If the order is for product under
Item 0005A, the estimated date by which the bulk vaccine
is expected to arrive at the Manufacturer’s facility for
processing (Manufacturer shall promptly notify the Buyer
if the materials fail to arrive by the date specified).
	 
	 	(5)	 	[ **** ]
	 
	 	(6)	 	Pick-up instructions for finished
vaccine and/or diluent;
	 
	 	(7)	 	The label Manufacturer shall place on
the bulk packages of vials of diluent and/or vaccine;
	 
	 	(8)	 	The estimated price for the order;
and
	 
	 	(9)	 	The pick-up date for the finished
vaccine and/or diluent.

	 	(c)	 	The price(s) to be paid for any order of vaccine or diluent
shall be based upon the actual quantity of vaccine or diluent filled
and finished under each delivery order at the unit price(s) set
forth in the Subcontract Schedule (Section B) on the date that the
order was issued (date order was received by Manufacturer).
	 
	 	(d)	 	No order for fill and finish of vaccine or diluent later may
be filled or finished later than 12 months after issuance of the
order, unless the parties mutually agree in writing.
	 
	 	(e)	 	Guaranteed Minimum Quantities:
	 
	 	 	 	ITEMS 0003A and 0003B – There is no minimum guaranteed minimum
quantity of facility change-overs that the Buyer will order. [
**** ].
	 
	 	 	 	ITEM 0004A – There is no guaranteed minimum quantity of diluent
that the Buyer will order under Item 0004. [ **** ].
	 
	 	 	 	ITEM 0004B – The guaranteed minimum quantity of diluent to
accompany IND ACAM 2000 vaccine is [ **** ].
	 
	 	 	 	ITEM 0005A – Quantities of vaccine that may be ordered under Item
0005A are dependent upon receipt of funded order(s) from the U.S.
Government for licensed smallpox vaccine or commercial orders. The
Buyer also anticipates that it may compete this Item 0005A
requirement at the time order(s) are issued, in which event the
Manufacturer will be given the opportunity to propose lower prices.
There is no guaranteed minimum quantity of approved vaccinia
vaccine that the Buyer will order to be filled, lyophilized,
finished, and tested under this Item.
	 
	 	 	 	ITEM 0005B – The number of manufacturing facility change-overs that
may be ordered under Item 0005B is dependent on the number of
separate campaigns of filled product

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	 	 	the Buyer orders under Item 0005A. Buyer will order one (1) change
over for each different product (e.g., ACAM 2000 or ACAM 1000)
ordered under Item 0005A.
	 
	 	 	 	ITEM 0006 – The need for diluent under Item 0006 will be dependent
upon receipt of funded order(s) for vaccine from the U.S.
Government or commercial orders. The Buyer anticipates that it may
compete (or perform in-house) this Item 0006 requirement at the
time a requirement for Item 0006 diluent arises. There is no
guaranteed minimum quantity of diluent that the Buyer will purchase
under Item 0006.
	 
	 	(f)	 	Ordering Periods

	 	(i)	 	Items 0003A and 0003B– [ **** ]
	 
	 	(ii)	 	Items 0004A and 0004B – [ **** ]
	 
	 	(ii)	 	Items 0005A and 0005B and 0006 – [ **** ] .

	G.3	 	PROGRAM OFFICER

	 	(a)	 	Performance of the work hereunder shall be subject to the
technical directions of the designated Program Officers for this
Subcontract. Such technical direction shall be issued between the
individuals specified in subparagraph (e) below.
	 
	 	(b)	 	As used herein, technical directions are directions to the
Manufacturer, 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 Subcontract
price/cost or period of performance, or any stated limitation
thereof. In the event that the Manufacturer feels that full
implementation of any of these directions may constitute a change to
the Subcontract requirements or exceed the scope of the Subcontract,
no action shall be taken and he or she shall notify the originator
of the technical direction and the Contractual Officer in a letter
separate of any required report(s). Such notification shall be given
within two (2) weeks from the date on which the Manufacturer knew or
should have known that the technical direction constituted a
contract change or exceeded the scope of the Subcontract. If the
Manufacturer fails to provide the required notification within the
above two (2) week period, it shall be deemed for purposes of this
Subcontract that the technical direction was not a change to
contract requirements and that such direction was within the scope
of the Manufacturer’s obligations. No technical direction, nor its
fulfillment, shall alter or abrogate the rights and obligations
fixed in this Subcontract.
	 
	 	(c)	 	The Buyer’s Program Officer is not authorized to change any
of the terms and conditions of this Subcontract. Changes shall be
made only by the Contractual Officer by properly written
modification to the Subcontract.
	 
	 	(d)	 	Buyer may from time to time change the person designated as
the Program Officer for this Subcontract by delivering a written
notice of such change to Manufacturer.
	 
	 	(e)	 	The designated Program Officers for this project are:
	 
	 	 	 	[ **** ]
	 
	 	 	 	[ **** ]

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	G.4	 	CONTRACTUAL OFFICER

	 	(a)	 	The Contractual Officer is the only individual who can legally commit
the Buyer to the
expenditure of funds. No person other than the Contractual Officer
can make any changes to the terms, conditions, general provisions,
or other stipulations of this Subcontract.
	 
	 	(b)	 	No information, other than that which may be contained in an
authorized modification to this Subcontract, duly issued by the
Contractual Officer, which may be received from any person employed
by the Buyer, or otherwise, shall be considered grounds for
deviation from any stipulation of this Subcontract.
	 
	 	(c)	 	Buyer may from time to time change the person designated as
the Contractual Officer for this Subcontract by delivering a written
notice of such change to Manufacturer.
	 
	 	(d)	 	The designated Contractual Officer for this Subcontract is:
	 
	 	 	 	[ **** ]

	G.5	 	CONTRACT COMMUNICATIONS/CORRESPONDENCE
	 
	 	 	The Manufacturer shall identify all correspondence, reports, and other
data pertinent to this Subcontract by imprinting thereon the Subcontract
number from the cover page of this Subcontract.

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	G.6	 	GOVERNMENT CLAIMS AGAINST BUYER BASED UPON MANUFACTURER’S SUBMISSION OF
DEFECTIVE COST OR PRICING DATA (MODIFICATIONS)

	 	(a)	 	Manufacturer shall be liable to Buyer for any and all losses or
liability that Buyer may incur to the Government as a result of
Government claims based upon: 1) any of the Manufacturer’s cost or
pricing data that was not accurate, current, and complete; including
but not limited to any cost or pricing data which Manufacturer was
required by Public Law (41 U.S.C. 254b) or the Federal Acquisition
Regulation (FAR Subpart 15.4) to provide, but which Manufacturer failed
to provide (defective cost or pricing data).
	 
	 	(b)	 	In the event the Government claims that any of the Manufacturer’s
cost or pricing data was defective, Buyer agrees that it shall: 1) give
Manufacturer the right to participate in any negotiations with the
Government on such claims and 2) that the Buyer shall not settle such
claims with the Government without the Manufacturer’s concurrence.
	 
	 	(c)	 	In the event that negotiations with the Government result in an
impasse and the Government issues a Final Decision of the Contracting
Officer against the Buyer on a Government claim as defined in paragraph
(a) above, Buyer shall promptly furnish to the Manufacturer a copy of
the Final Decision of the Contracting Officer. If the Manufacturer
requests in writing within thirty (30) days of Manufacturer’s receipt
of the Final Decision, permission to file an appeal from the
Contracting Officer’s Final Decision, Buyer shall grant the
Manufacturer permission to file such an appeal, in the name and with
the consent of the Buyer, at Manufacturer’s expense. Nothing herein
shall be construed, however, to create privity of contract between the
Manufacturer and the Government or to allow the Manufacturer, as
subcontractor, to pursue any contract claim directly against the
Government.

	G.7	 	BUYER’S OBLIGATION TO PAY
	 
	 	 	Buyer agrees to make payment within thirty (30) days of receipt of a
properly submitted invoice or voucher.

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Section H – Special Contract Requirements

	H.1	 	KEY PERSONNEL
	 
	 	 	The key personnel cited below are considered essential to the work being
performed under the Subcontract. If these individuals leave the
Manufacturer’s employ or are reassigned to other programs, the
Manufacturer shall notify the Contractual 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 Manufacturer without the
written consent of the Contractual Officer.

	 	 	 
	Personnel	 	Title
	[ **** ]
	 	[ **** ]
	[ **** ]
	 	[ **** ]

	H.2	 	BUYER’S PROVISION OF BATCH RECORDS
	 
	 	 	Buyer will provide Manufacturer with a signed batch record at least one
week in advance of a planned fill.
	 
	H.3	 	RESERVATION OF MANUFACTURING CAPACITY AND UNDERUTILIZATION FEES (ITEM
0001A — IND ACAM 2000 VACCINE)

	 	(a)	 	Manufacturer shall reserve manufacturing capacity from [
**** ] to satisfy Buyer’s orders for services under Item 0001A.

	 	(i)	 	Buyer will pay Manufacturer a “missed fill”
underutilization fee of [ **** ] for the 6th missed fill
and each missed fill thereafter. [ **** ].
	 
	 	(ii)	 	Buyer will pay Manufacturer a “partial fill”
underutilization fee if Buyer provides insufficient bulk
vaccine to enable the Manufacturer to fill and finish at least
[ **** ] vials of ACAM 2000 [ ****
].

	 	(b)	 	Manufacturer may invoice for the “missed fill”
underutilization fee (paragraph (a)(i) above) immediately upon the
occurrence of a missed fill. The Manufacturer may invoice for any
“partial fill” underutilization fee (paragraph (a)(ii) above) upon
completion of each additional fill required under paragraph (a)(ii)
above to make-up underutilization due to partial fill(s).

	H.4	 	RESERVATION OF MANUFACTURING CAPACITY, GUARANTEED PAYMENT, AND ADVANCE PAYMENTS (ITEM 0002 — IND ACAM 1000 VACCINE AND/OR IND ACAM 2000 VACCINE)
	 
	(a)	 	Reservation of Manufacturing Capacity. Manufacturer shall reserve
manufacturing capacity from [ **** ] to provide the manufacturing
capability required by Item 0002 and to perform change-over activities
under Items 0003A and 0003B.
	 
	 	 	[ **** ]
	 
	 	 	[ **** ]
	 
	 	 	[ **** ]
	 
	 	 	[ **** ]

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

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

	 	(a)	 	The anticipated dates for the fill, lyophilization, and
finish of ACAM 2000 under Item 0001A are attached hereto at Section
J, Attachment G. [ **** ]. The Manufacturer shall be notified of
the planned Item 0002 schedules at least 45 days prior to initiation
of the required campaign and such schedule shall be added to this
Subcontract at Section J, Attachments H and I.
	 
	 	(b)	 	Buyer will provide Manufacturer notice of the actual planned
date for shipment of bulk vaccine to Manufacturer and the actual
vaccine fill date no later than ten (10) working days prior to that
fill date. Manufacturer shall fill all bulk vaccine as soon as
reasonably practicable based on a fill schedule of 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.

	H.6	 	VALIDATION OF CONSISTENCY OF MANUFACTURE
	 
	 	 	Manufacturer shall demonstrate consistency of its fill, finish and
lyopholization process by manufacturing three (3) consecutive conformance
lots of ACAM 2000 vaccine that conform to subcontract requirements. [
**** ].
	 
	H.7	 	PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES
	 
	 	 	The Manufacturer 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 10, United Stated Code (Public Law 101-121,
effective 12/23/89), 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 on 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.8	 	SMOKE FREE ENVIRONMENT

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	 	In compliance with Department of Health and Human Services (DHHS)
regulations, all Manufacturer 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 that are open to the public. This
policy is also applicable to Manufacturer personnel who do not work
full-time within CDC/ATSDR facilities, but are attending meetings within
CDC/ATSDR facilities.
	 
	H.9	 	REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS
	 
	 	 	The Representations, Certifications and Other Statements of Offerors
submitted by Manufacturer are hereby incorporated by reference, with the
same force and effect as if they were given in full text.(See Section J,
Attachment E)
	 
	H.10	 	LABORATORY LICENSE REQUIREMENTS
	 
	 	 	The Manufacturer shall comply with all applicable FDA requirements of
Section 353 of the Public Health Services Act (Clinical Laboratory
Improvement Act as amended) and the Current Good Manufacturing Practice
Regulations (cGMP). This requirement and any applicable current Good
Laboratory Practice (cGLP) shall also be included in any subcontract for
manufacturing and laboratory services under this Subcontract. This
requirement shall also be included in any Subcontract for services under
this Subcontract.
	 
	H.11	 	MANUFACTURING STANDARDS

	 	(a)	 	The Current Good Manufacturing Practice Regulations (cGMP)
(21 CFR Parts 210-211 or successor regulations) will be the standard
to be applied for manufacturing, processing and packing of vaccine
and diluent under this Subcontract.
	 
	 	(b)	 	Manufacturer shall promptly inform the Buyer of any FDA
citation of a deviation from cGMP relating to the facilities or
processes related to performance of this Subcontract. If at any time
during the life of the Subcontract, the items listed under this
Subcontract fail to meet cGMP and/or Manufacturer fails to timely
remedy a negative Food and Drug Administration Quality Assurance
Evaluation to the satisfaction of the FDA, such failure shall be
deemed to be a breach of a material contract requirement and shall be
grounds for default termination.
	 
	 	(c)	 	If at any time during the life of the Subcontract, the
Manufacturer 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 Manufacturer shall have thirty (30) calendar days
from the time such material failure is identified to cure such
material failure. If the Manufacturer fails to take such an action
within the thirty (30) calendar day period, then the Subcontract may
be terminated.

	H.12	 	INSURED LOSSES
	 
	 	 	This Subcontract procures services to manufacture smallpox vaccine for
use by the Government. If the vaccine becomes damaged or destroyed
during contract performance and the Manufacturer receives monies as part
of any insurance coverage, the Buyer shall be entitled to receive a
pro-rata share of any recovered monies.

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	H.13	 	DISSEMINATION OF INFORMATION
	 
	 	 	No information related to, obtained, or generated under this Subcontract
shall be released or publicized without prior written consent of the
Contractual Officer.
	 
	H.14	 	SECURITY REQUIREMENTS

	 	(a)	 	Security Plan Requirement
	 
	 	 	 	The Manufacturer shall develop and submit a written Security Plan to
the Contractual Officer and Program Officer within 30 calendar days
after award of the Subcontract. The Security Plan shall describe the
procedures to be utilized to control the general internal operations
of the firm and a description of Manufacturer’s facility(ies) in which
the work will be performed—including any subcontractors.
[ **** ].
	 
	 	 	 	[ **** ]
	 
	 	 	 	This security plan shall also include the Manufacturer’s plans for
conducting background investigations on all employees and
subcontractors who will have access to any activity undertaken by the
Manufacturer that relates to this Subcontract. The Buyer will review
the plan and submit comments to the Manufacturer. The Manufacturer
shall revise the Security Plan, if required, and submit a final
Security Plan to the Buyer with ten (10) working days after receipt of
the comments.
	 
	 	 	 	Performance of work under this Subcontract shall be in accordance with
the Manufacturer’s approved written Security Plan.

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ACAMBIS CONFIDENTIAL —
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	 	(b)	 	Contract Closeout
	 
	 	 	 	Upon completion of the work of this Subcontract, including delivery of
all required deliverables:

	 	(1)	 	the Manufacturer shall submit to the Contractual
Officer a statement certifying that all non-public data and
information created by the Manufacturer or made available to
the Manufacturer during the performance of this Subcontract
has been purged from all storage components of its facilities,
including computer system backup tapes, and that no source
document or output has been retained by the Manufacturer, or,
	 
	 	(2)	 	if documentation is required to be maintained by
the Manufacturer by law or regulation, or immediate purging is
not possible, the Manufacturer shall submit a list of all such
material in its control, along with the names of those with
access to the material, whether access is electronic via an
individual account or group account, or is physical, and shall
certify that such material remaining in its control, including
system backup tapes, will be safeguarded to prevent any
unauthorized use or disclosure.

	H.15	 	DELIVERY ORDER AUTHORITY
	 
	 	 	The Contractual Officer or any individual so designated by the
Contractual Officer shall be the only Buyer’s officials authorized to
place delivery orders under this Subcontract. The Manufacturer shall not
accept any delivery order or verbal request from other Buyer personnel.
	 
	H.16	 	CONFIDENTIALITY OF PROPRIETARY AND OTHER INFORMATION

	 	(a)	 	Each party agrees that, during the term of this Subcontract and for
a period of ten (10) years following its termination or completion, it
shall (1) use any Proprietary Information disclosed to it only for the
purpose of performance under this Subcontract and any follow-on
subcontract as may be awarded by Acambis Inc. to the Manufacturer, (2)
not disclose Proprietary Information to any third party, or to any
employee who does not have a need-to-know such information, and (3)
employ the same standard of care it uses to protect its own Proprietary
Information. To be considered “Proprietary Information” under this
clause, the information must be (a) disclosed in written or tangible
form and appropriately marked as proprietary, or (b) if disclosed
orally or visually, clearly identified as proprietary at the time of
disclosure. Information shall not be deemed to be proprietary if such
information is already known without restriction to a receiving party;
or is rightfully received without restriction by the receiving party
from a third party having the right to disclose the information; or
becomes publicly available through no wrongful act of the receiving
party; or is hereafter furnished by the disclosing party without a
similar restriction on disclosure; or is independently developed by the
receiving parity without breach of this agreement. The receiving party
shall not be liable for inadvertent disclosure or use of the
information received hereunder if, upon discovery of such, it shall
take reasonable steps to prevent any further inadvertent disclosure or
unauthorized use. The receiving party may make disclosures to the
Government as required under the prime contract. The receiving party
may make disclosures required by operation of law, provided that the
receiving party shall give the disclosing party reasonable advance
notice to provide the disclosing party an opportunity to contest the
requirement of disclosure. No license is either granted or implied by
the conveyance of Proprietary Information by either party.
	 
	 	(b)	 	Additionally, Manufacturer shall obtain a Confidentiality Agreement
(See Section J, Item B) from each employee involved in the performance
of this subcontract prior to the employee’s performing any task
hereunder. Copies of such agreements shall be maintained in the
Manufacturer’s

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	 	 	company records and shall be available for Government or Buyer inspection
upon request at Manufacturer’s facility.

	H.17	 	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.

	H.18	 	INDEMNIFICATION (U.S. GOVERNMENT SALES OF ACAM 1000)
	 
	 	 	The Buyer shall indemnify, defend, and hold harmless the Manufacturer
from any product liability claims and associated cost resulting from
acts, omissions, and mishandling of Item 0002 or 0005A ACAM 1000 vaccine
sold to the U.S. Government other than matters under the Manufacturer’s
direct control and responsibility. With respect to claims, losses, and
liabilities for personal injury or physical property damage that arise
under Item 0002 or 0005A ACAM 1000 vaccine sold to the U.S. Government,
Manufacturer agrees to indemnify and hold Buyer harmless, except to the
extent that such claims, liabilities or losses shall arise out of Buyer’s
own negligence or the negligence of Buyer’s employees, agents or
subcontractors other than Manufacturer. In no event shall either party
be liable to the other, as a result of the performance of this contract
for any loss of profits or any incidental, special, exemplary or
consequential damages.

24

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	H.19	 	INDEMNIFICATION (U.S. GOVERNMENT SALES OF ACAM 1000 AND ACAM 2000)

(a)  Contractor shall request the U.S. Government to indemnify the
Subcontractors from certain unusually hazardous risks associated with the
manufacture, kitting and [ **** ] of the Items 0001A, 0002, and 0005A
vaccine sold to the U.S. Government, as described in the following provision:

	 	 	 	Indemnification Under Public Law 85-804 (Applicable to Vaccine Sold to
the U.S. Government via Subcontracts under Prime Contracts 200-2000-00001
and 200-2002-00004)
	 
	 	(a)	 	“Subcontractor’s principal officials,” as used in this clause,
means directors, officers, managers, superintendents, or other
representatives supervising or directing—

	 	(1)	 	All or substantially all of the Subcontractor’s
business;
	 
	 	(2)	 	All or substantially all of the Subcontractor’s
operations at any one plant or separate location in which this
subcontract is being performed; or
	 
	 	(3)	 	A separate and complete major industrial operation in
connection with the performance of this subcontract.

	 	(b)	 	Under Public Law 85-804 (50 U.S.C. 1431-1435) and Executive Order
10789, as amended, and regardless of any other provision of this
subcontract, the Government shall, subject to the limitations contained
in the other paragraphs of this clause, indemnify the subcontractor
against—

	 	(1)	 	Claims (including reasonable expenses of litigation or
settlement) by third persons (including the Contractor and
employees of the Contractor or Subcontractors) for death;
personal injury; or loss of, damage to, or loss of use of
property;
	 
	 	(2)	 	Loss of, damage to, or loss of use of Contractor
property, excluding loss of profit;
	 
	 	(3)	 	Loss of, damage to, or loss of use of Subcontractor
property, excluding loss of profit; and
	 
	 	(4)	 	Loss of, damage to, or loss of use of Government
property, excluding loss of profit.
	 
	 	(5)	 	Litigation, arbitration, or alternative dispute
resolution-related expenses if Subcontractor is required by the
Government or the Contractor, as a condition of indemnification,
to sue insurance carriers that decline to compensate for claims
for losses related to this Subcontract.

	 	(c)	 	This indemnification applies only to the extent that the claim,
loss, or damage:

	 	(1)	 	Arises out of or results from risks defined below as
“unusually hazardous” and
	 
	 	(2)	 	Is not compensated for by insurance or otherwise.

	 	 	 	Any such claim, loss, or damage, to the extent that it is within the
deductible amounts of the Subcontractor’s insurance, is not covered under
this clause. If insurance coverage or other financial protection in
effect on the date (Enter Date:
                         ) the Government
approving official authorized the use of this clause is reduced, the
Government’s liability under this clause shall not increase as a result.
	 
	 	(d)	 	The following risks are defined to be “unusually hazardous” for the
purposes of this indemnification agreement:

	 	(1)	 	Alleged adverse reactions in humans resulting
from administration of vaccine, vaccine placebos, or other
materials used in the development of the vaccine incident to
contract performance; or resulting from the administration of
vaccine delivered or otherwise furnished under the contract,
irrespective of whether such vaccine was furnished, delivered,
or administered to humans prior to or after FDA licensure, and

25

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	(2)	 	The alleged release of toxic materials (including
infectious agents) into the environment that is alleged to
have resulted in environmental damage or human exposure to
such toxic materials that were involved in the development,
testing, manufacture, [ **** ], transportation, or disposal
of vaccine under the contract.
	 
	 	(3)	 	“Adverse reactions” include anaphylaxis and any
other adverse reactions, whether foreseeable or not,
including, but not limited to:

	 	i.	 	Adverse reactions resulting from
the administration of the vaccine, vaccine placebo, or
other materials involved in the development of the
vaccine, including challenge materials,
	 
	 	ii.	 	The failure of the vaccine to
function as intended or to fail to confer immunity,
	 
	 	iii.	 	Side effects or performance of
the vaccine in a manner not intended, and
	 
	 	iv.	 	Reactions that may be manifested
long after exposure to the vaccine, vaccine placebo,
or other materials associated with the development or
manufacture of the vaccine (including challenge
materials), which reactions are directly attributable
to or result from the administration of such vaccine,
vaccine placebo, or other materials.

	 	(4)	 	“Acts of Terrorism,” meaning any act of one or
more persons, whether or not agents of a sovereign power, for
political or terrorist purposes and whether the loss or damage
resulting therefrom is accidental or intentional.

	 	(e)	 	When the claim, loss, or damage is caused by the willful misconduct
or lack of good faith on the part of any of the Subcontractor’s
principal officials, the Subcontractor shall not be indemnified for—

	 	(1)	 	Government claims against the Subcontractor (other than
those arising through subrogation); or
	 
	 	(2)	 	Loss or damage affecting the Subcontractor’s property.

	 	(f)	 	Neither the Government nor the Contractor shall be liable to the
Subcontractor under this or any other subcontract provision for any
liability arising from Subcontractor’s indemnification of any
subcontractor at a lower tier unless such lower-tier indemnification
provisions have been approved in writing by both the Government and the
Contractor.
	 
	 	(g)	 	The rights and obligations of the parties under this clause shall
survive the subcontract’s termination, expiration, or completion. No
payments shall be required to be made under this clause unless the
agency head determines that the amount is just and reasonable. The
Government shall pay the Subcontractor directly for any amounts payable
hereunder; or may directly pay the parties to whom the Subcontractor is
alleged to be or found liable.
	 
	 	(h)	 	The Subcontractors shall—

	 	(1)	 	Promptly notify the Prime Contractor and the Government
Contracting Officer of any claim or action against, or any loss
by, the Subcontractor that may be reasonably expected to involve
indemnification under this clause;
	 
	 	(2)	 	Immediately furnish to the Government and Prime
Contractor copies of all pertinent papers the Subcontractor
receives;
	 
	 	(3)	 	Furnish evidence or proof of any claim, loss, or damage
covered by this clause in the manner and form the Government
requires; and
	 
	 	(4)	 	Comply with the Government’s directions and execute any
authorizations required in connection with settlement or defense
of claims or actions.

	 	(i)	 	The Government may direct, control, or assist in settling or
defending any claim or action that may involve indemnification under
this clause.

26

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	(j)	 	Notwithstanding any other provision of this Subcontract: (1) no
settlement shall be executed involving sums to be paid by
Subcontractors (e.g., deductible amounts on Subcontractor’s insurance
policies) unless Subcontractors consent to the settlement; and (2)
Subcontractor shall not be required to take any action in violation of
any existing insurance policy.

(b)  [ **** ]. If and when the U.S. Government approves indemnification of the
Subcontractors, the above provision, as revised to the extent required by the
U.S. Government, shall be incorporated into this subcontract.

	H.20	 	SOLICITATION OF EMPLOYEES
	 
	 	 	Each of the parties agrees that, during the term of this Subcontract and
for a period of one (1) year thereafter, it will not directly solicit or
recruit the employees of the other party associated with the performance
of this Subcontract. Nothing herein shall preclude any employee of either
party from pursuing and securing employment opportunities with the other
party on such employee’s own initiation.
	 
	H.21	 	ASSIGNMENT OF CLAIMS
	 
	 	 	Assignment of this Subcontract, or any interest therein, or any payment
due or to become due thereunder, without the prior written consent of
Buyer shall be void. Should Buyer approve any assignment thereof, in no
event shall any copy of any part or all of this Subcontract which is
marked “Top Secret”, “Secret,” “Confidential”, or “Proprietary
Information” be furnished to any assignee of any claim arising under this
Subcontract, or to any person not entitled to receive the same, without
prior written consent of Buyer.
	 
	H.22	 	WAIVER OF BREACH
	 
	 	 	No waiver of a breach of any provision of this Subcontract shall
constitute a waiver of any other breach of such provision. Failure of
either party to enforce at any time, or from time to time, any provision
of this Subcontract shall not be construed as a waiver thereof. The
remedies herein shall be cumulative and additional to any other remedies
in law and in equity.
	 
	H.23	 	COMPLIANCE WITH LAWS
	 
	 	 	Manufacturer agrees to comply with all applicable federal, state and
municipal laws and ordinances and all rules and regulations thereunder,
and all provisions required thereby to be included herein are hereby
incorporated by reference.
	 
	H.24	 	INDEPENDENT CONTRACTOR
	 
	 	 	It is understood and agreed that Manufacturer shall be deemed to be an
independent contractor in all its operations and activities hereunder;
that the employees furnished by Manufacturer to perform work hereunder
shall be deemed to be Manufacturer’s employees exclusively, without any
relation to Buyer as employees of an independent contractor; that said
employees shall be paid by Manufacturer for all services in this
connection, and that Manufacturer shall be responsible for all obligations
and reports covering social security, unemployment insurance, workers’
compensation, income tax, and other reports and deductions required by
state or federal law.

27

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	H.25	 	CLAUSE MODIFICATION REQUIRED BY BUYER’S CUSTOMER
	 
	 	 	Manufacturer agrees to incorporate into this Subcontract any revised
clause or additional clause as Buyer may reasonably deem necessary to
enable Buyer to comply with the provisions of the prime contract with the
Government and any modifications thereto. If such revised clause or
additional clause causes any increase or decrease in the cost of or time
required for performance of the contract work, an equitable adjustment
shall be made in accordance with the Changes clause hereof.
	 
	H.26	 	DEFAULT FOR INSOLVENCY
	 
	 	 	Buyer may terminate forthwith this contract for default in the event of
the occurrence of any of the following: (i) insolvency of the Manufacturer
(Manufacturer shall be deemed to be insolvent if it has ceased to pay its
debts in the ordinary course of business or cannot pay its debts as they
become due, whether it has filed for bankruptcy or not and whether
insolvent within the meaning of the Federal Bankruptcy Code or not); (ii)
the filing of a voluntary petition to have Manufacturer declared bankrupt;
(iii) the appointment of a receiver or trustee for Manufacturer; or (iv)
the execution by Manufacturer of an assignment for the benefit of
creditors.
	 
	H.27	 	DISPUTES
	 
	 	 	Any dispute arising under, out of, or in connection with this Subcontract,
that is not resolved by agreement of the parties, may be resolved by
alternative dispute resolution procedures as may be agreed to by the
parties or by appropriate legal proceedings. Such legal proceedings
between the parties shall be brought and jurisdiction and venue shall be
proper only in the Federal District Court for the District of
Massachusetts or, if jurisdiction is lacking, the Courts of the
Commonwealth of Massachusetts. Pending any decision, appeal, or judgment,
or the settlement of any such dispute, Manufacturer shall proceed
diligently with the performance of the work under this Subcontract (except
to the extent that Buyer has cancelled or terminated the contract work).
	 
	H.28	 	GOVERNING LAW
	 
	 	 	The validity, construction, scope and performance of this Subcontract,
including any attachments and modifications hereto, and all disputes
related thereto, shall be governed by the laws of the Commonwealth of
Massachusetts, without regard to its “Choice of Law” provisions; except
that with respect to any provisions hereof which are governed by the laws
of United States of America, said laws of the United States shall apply,
and with respect to any provisions “flowed down” from the Prime Contracts
or based upon FAR clauses, such provisions shall be interpreted and
governed by that body of federal procurement law interpreting such
provisions.
	 
	H.29	 	VALIDITY OF INDIVIDUAL PROVISION
	 
	 	 	The invalidity, in whole or in part, of any provision of this Subcontract
shall not void or otherwise affect the validity of any other provision.

28

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

Section I – Contract Clauses

Section I – 1 – Clauses Incorporated By Reference

     52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

	 	 	 	The Federal Acquisition Regulation (FAR) and Health And Human Services
Supplemental Acquisition Regulation (HHSAR) clauses identified herein
below are hereby incorporated into this Subcontract by reference with
full force and effect. The additional HHSAR clauses augment and
supplement the FAR clauses, taking precedence thereover to any extent
inconsistent therewith.
	 
	 	 	 	All such clauses, as well as any other FAR or HHSAR clauses referred to
elsewhere in this Subcontract, shall with respect to the rights, duties,
and obligations of the Buyer and the Manufacturer thereunder, be
interpreted and construed in such manner as to recognize and give effect
to (i) the contractual relationship between the Buyer and Manufacturer
under this Subcontract and (ii) the rights of the Government with respect
thereto under the prime contract from which such clauses are derived.
Where rights, duties and obligations are expressed herein as applying to
the “Government” the “United States,” or the “Contracting Officer”, they
shall generally apply by reason of the flow down to the “Buyer”; and
where expressed herein as applying to the “Contractor”, they shall
generally apply by reason of the flow down to the “Manufacturer”.
However, the terms “Government” or “Contracting Officer” do not change
(i) in the phrases “Government Property”; “Government-Owned Property,”
“Government Equipment” or “Government-Owned Equipment”; (ii) when a
right, act, authorization or obligation can only be exercised by the
Government or the Contracting Officer under the prime contract or his
duly authorized representative, (iii) when title to property is to be
transferred directly to the Government, (iv) where specifically noted
below, and (v) in FAR 52.227-1 and 52.227-2.

	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.215-21	 	
Requirements for Cost or Pricing Data or Information Other Than
Cost or Pricing Data – Modifications (Oct 1997) Alternate I
(Oct 1997)
	52.227-1	 	
Authorization and Consent (Jul 1995) Alternate I (Apr 1984)
	52.227-2	 	
Notice and Assistance Regarding Patent and Copyright
Infringement (Aug 1996)
	52.227-14	 	
Rights in Data—General (Jun 1987), Alternate I (Jun 1987)
	52.227-16	 	
Additional Data Requirements (Jun 1987)
	52.232-1	 	
Payments (Apr 1984)
	52.232-17	 	
Interest (Jun 1996)
	52.232-23	 	
Assignment of Claims (Jan 1986)
	52.242-13	 	
Bankruptcy (Jul 1995)
	52.243-1	 	
Changes-Fixed Price (Aug 1987) (Alt V)(Apr 1984)
	52.245-2	 	
Government Property (Fixed Price Contracts) (Dec 1989)

29

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	 	 
	HHSAR SOURCE	 	TITLE AND DATE
	352.224-70	 	
Confidentiality of Information (Apr 1984)
	352.232-9	 	
Withholding of Contract Payment (Apr 1984)

Section I – 2 – Clauses Incorporated In Full Text

	I.2	 	FAR 52.216-18 ORDERING (OCT 1995) (MODIFICATION) (Items 0003A, 0003B,
0004A, 0004B, 0005A, 0005B, and 0006)

	 	(a)	 	Any supplies and services to be furnished under this Subcontract
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 a task order and this Subcontract, this
Subcontract shall control.
	 
	 	(c)	 	Deleted.

	I.3	 	FAR 52.216-19 ORDER LIMITATIONS (OCT 1995) (MODIFICATION) (Items 0003A,
0003B, 0004A, 0004B, 0005A, 0005B, and 0006)

	 	(a)	 	Minimum Orders.

	 	(1)	 	When the Buyer requires supplies or services
covered under Subcontract Items 0004A or 0004B of this
Contract in an amount less than the manufacture, fill and
finish of 90,000 vials of diluent, the Manufacturer is not
obligated to furnish those supplies and related services under
the contract.
	 
	 	(2)	 	When the Buyer requires supplies or services
covered by Subcontract Item 0005A of this Contract in an
amount less than the fill and finish of [ **** ] vials of
vaccine, the Manufacturer is not obligated to furnish those
supplies and related services under the contract.
	 
	 	(3)	 	When the Buyer requires supplies or services
covered by Subcontract Item 0006 of this Contract in an amount
less than the manufacture, fill and finish of [ **** ]
vials of diluent, the Manufacturer is not obligated to furnish
those supplies and related services under the contract.

	 	(b)	 	Maximum Orders.

	 	(1)	 	Subcontract Items 0004A and 0004B have no maximum
order quantity.
	 
	 	(2)	 	For Subcontract Item 0005A, the Manufacturer is
not obligated to honor any single order in excess of [ ****
] vials of vaccine.
	 
	 	(3)	 	For Subcontract Item 0006, the Manufacturer is
not obligated to honor any single order in excess of [ ****
] vials of diluent.

	 	(c)	 	Items 0003A, 0003B, and 0005B have no minimum or maximum order
quantity.

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ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	(d)	 	Notwithstanding paragraph (b) of this section, the
Manufacturer 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 Manufacturer’s intent not
to fill and finish the item (or items) called for and the reasons.

	I.4	 	FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995) (Modification) (Items 0003A,
0003B, 0004A, 0004B, 0005A, 0005B, and 0006)

	 	(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
Manufacturer shall furnish to the Buyer, 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 Buyer
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 Buyer 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
Manufacturer within the time specified in the order. The contract
shall govern the Manufacturer’s and Buyer’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.

	I.5	 	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 Manufacturer 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
Manufacturer 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);

31

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

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

	I.6	 	DEFAULT (FIXED PRICE)

	 	(a)(1)	 	The Buyer may, subject to paragraphs (c) and (d) of this clause,
by written notice of default to the Manufacturer, terminate this
Subcontract in whole or in part if the Manufacturer fails to –

	 	(i)	 	Deliver the supplies or to perform the services
within the time specified in this Subcontract or any extension
	 
	 	(ii)	 	Make progress, so as to endanger performance of
this Subcontract (but see subparagraph (a)(2) of this clause);
or
	 
	 	(iii)	 	Perform any of the other provisions of this
Subcontract (but see subparagraph (a)(2) of this clause).
	 
	 	(2)	 	The Buyer’s right to terminate this Subcontract
under subdivisions (a)(1)(ii) and (1)(iii) of this clause, may
be exercised if the Manufacturer does not cure such failure
within 10 days (or more if authorized in writing by the
Contractual Officer) after receipt of the notice from the
Contractual Officer specifying the failure. The failure of
Buyer to issue such notice to the Manufacturer, or to give the
Manufacturer at least 10 days within which to cure its failure
to perform under subdivisions (a)(1)(ii) or (1)(iii), shall
not be a basis to invalidate a default termination if, in
fact, the Manufacturer was either failing to make progress so
as to endanger performance or was in breach of a material
contract requirement.

	 	(b)	 	If the Buyer terminates this Subcontract in whole or in part,
it may acquire, under the terms and in the manner the Contractual
Officer considers appropriate, supplies or services similar to those
terminated, and the Manufacturer will be liable to the Buyer for any
excess costs for those supplies or services. However, the
Manufacturer shall continue the work not terminated.
	 
	 	(c)	 	Except for defaults of subcontractors at any tier, the
Manufacturer shall not be liable for any excess costs if the failure
to perform the Subcontract arises from causes beyond the control and
without the fault or negligence of the Manufacturer. Examples of
such causes include (1) acts of God or of the public enemy, (2) acts
of the Government in either its sovereign or contractual capacity,
(3) fires, (4) floods, (5) epidemics, (6) quarantine restrictions,
(7) strikes, (8) freight embargoes, and (9) unusually severe
weather. In each instance the failure to perform must be beyond the
control and without the fault or negligence of the Manufacturer.

32

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	 	(d)	 	If the failure to perform is caused by the default of a
subcontractor at any tier, and if the cause of the default is beyond
the control of both the Manufacturer and subcontractor, and without
the fault or negligence of either, the Manufacturer shall not be
liable for any excess costs for failure to perform, unless the
subcontracted supplies or services were obtainable from other
sources in sufficient time for the Manufacturer to meet the required
delivery schedule.
	 
	 	(e)	 	If this Subcontract is terminated for default, the Buyer may
require the Manufacturer to transfer title and deliver to the Buyer
or to the Government, as directed by the Contractual Officer, any
(1) completed supplies, and (2) partially completed supplies and
materials, parts, tools, dies, jigs, fixtures, plans, drawings,
information, and contract rights (collectively referred to as
“manufacturing materials” in this clause) that the Manufacturer has
specifically produced or acquired for the terminated portion of this
Subcontract. Upon direction of the Contractual Officer, the
Manufacturer shall also protect and preserve property in its
possession in which the Buyer or the Government has an interest.
	 
	 	(f)	 	The Buyer shall pay contract price for completed supplies
delivered and accepted. The Manufacturer and Contractual Officer
shall agree on the amount of payment for manufacturing materials
delivered and accepted and for the protection and preservation of
the property. The Buyer may withhold from these amounts any sum the
Contractual Officer determines to be necessary to protect the Buyer
against loss because of outstanding liens or claims of former lien
holders.
	 
	 	(g)	 	If, after termination, it is determined that the Manufacturer
was not in default, or that the default was excusable, the rights
and obligations of the parties shall be the same as if the
termination had been issued for the convenience of the Buyer.
	 
	 	(h)	 	The rights and remedies of the Buyer in this clause are in
addition to any other rights and remedies provided by law or under
this Subcontract. Additionally, if the Buyer elects to waive its
right to terminate the Manufacturer for default under paragraph
(a)(1)(i) or (iii) by accepting late deliveries or nonconforming
performance, the Buyer shall retain the right to recover any damages
allowed by law resulting from the Manufacturer’s breach of its
Subcontract obligations.

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	 	Planned Vaccine Schedule — US Government IND ACAM 2000 (Item 0001A)

33

 

ACAMBIS CONFIDENTIAL  –  PROPRIETARY INFORMATION

	H	 	Planned Vaccine Schedule – Commercial IND ACAM 2000 (Item 0002) [Buyer shall set the schedule of exact fill dates after
contract award]
	 
	I	 	Planned Vaccine Schedule – US Government IND ACAM 1000 (Item 0002) [Buyer shall set the schedule of exact fill dates after
contract award]

34exv4w35

 

EXHIBIT 4.35

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 Mod 0001

	 	 	 	 	 	 	 
	Requested by:	 	
Authorization:	 	 	 	 
	[****]	 	
1. [****]
	 	2.	 	 
	 	 	 	 	 	 	

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

1111 S. Paca Street

Baltimore MD 21230-2591	 	
(1) ACAM 2000 US Govt Program

(2) Same terms and conditions apply as PO 28890 and Subcontract

200-2002-00012(CBL) except as modified below.

	 	 	 	 	 	 	 	 	 	 	 
	Customer Order No.:	 	 	 	Date Needed:
	 	 	 	Date Requested:	 	 
	 	 	

	 	 	 	

	 	 	 	

	 	 	 	 	 	 	 	 	 	 	 
	Line #	 	Quantity	 	Unit	 	Description	 	Unit Price	 	Estimated Price
	
	 	
	 	
	 	
	 	
	 	

	1	 	
1

Exp
	 	Lot

Project
	 	Fill and finish 1
lot of
media/placebo in
accordance with
Attch A, Statement
of Work, to
Subcontract
200-2002-00012(CBL)
	 	[****] / vial
	 	[****]**
	 	 	 	 	 	 	 	 	 	 	 
	2	 	
2

Exp
	 	Studies

Project
	 	Perform thawing
studies per
attached e-mail and
in accordance with
CBL’s standard
operating
procedures
	 	[****] / study
	 	[****]

	 	 	 	 	 	 	 	 	 	 	 
	 	 	
 
	 	 
	 	 
	 	Estimated Total

Price Mod 0001
	 	[****]

	 	(A)	 	This Mod 0001 increases the estimated total price of PO 28890 from: [****] by [****] to [****]
	 
	 	(B)	 	By signing this purchase order below, 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 1 scheduled fill closest to the date CBL performs the Line #1
media/placebo fill and for the 1 scheduled fill closest to the date CBL performs the 2 Line #2 thawing studies.

	**	 	This estimated price is based on an estimated quantity of [****] finished vials. Final billing shall be based on the number of completed
vials actually filled and finished.

Authorized Signature [****] Date: 11 June 02

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

	 	 	 	 	 	 	 	 	 	 	 
	Company Representative	 	 	 	Date 11 June 02
	 	 	 	Confirmation No.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00054-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00054-of-00352.parquet"}]]