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:
Acambis, Inc.
38 Sidney Street
Cambridge, MA 02139
|
Subcontract No:
200-2002-00012(CBL)
Prime Contracts Nos: 200-2002-00004 &
200-2000-00001
Contractual Officer: **********
Program Officer: **********
|
|
|
|
|
|
AND
|
|
|
|
|
|
Chesapeake Biological
Laboratories, Inc.
1111 S. Paca Street
Baltimore, MD 21230-2591
|
|
This
Subcontract is entered into effective this 30 th 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
|
|
|
|
|
|
|
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
vials
|
|
**********
|
|
**********
|
|
|
|
Finish and
Perform
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
Table 1
|
Price per
Vials
For Items
0001 & 0002
|
|
Cumulative Number of
Vials of ACAM 2000 Ordered
by Buyer 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 agreed to
prior
|
|
|
|
|
|
|
|
Specified Quality
Control
|
|
to issuance of any
order]
|
|
|
|
|
|
|
|
Tests For Licensed
ACAM
|
|
|
|
|
|
|
|
|
|
1000 or 2000 Vaccine
as
|
|
|
|
|
|
|
|
|
|
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
issuance of any order]
|
|
|
|
|
|
|
|
Facility After
Filling
|
|
|
|
|
|
|
|
|
|
ACAM 1000 or
2000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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
|
|
|
|
|
|
|
|
|
Page 4 Of
35
|
|
|
|
|
|
|
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 agreed to
prior
|
|
|
|
|
|
|
|
|
|
Quality Control
Tests
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
Page 5 Of
35
|
|
|
|
|
|
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.
|
|
|
|
|
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,
|
|
|
|
|
|
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.
|
|
|
|
|
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.
|
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 **********
|
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
|
|
|
|
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).
|
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
Copies
|
|
|
Delivery
Date
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
(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.
|
|
|
|
|
|
|
|
|
|
|
|
F.2
|
PERIOD OF
PERFORMANCE
|
|
|
(a)
|
The period of performance
for this Subcontract will be from Subcontract Award
until January 31, 2007.
|
|
|
(b)
|
The period of performance
for:
|
|
|
|
(i) Item 0001A is from
April 11, 2002 to September 30, 2002;
|
|
|
|
(ii) Item 0002 is from
October 1, 2002 to August 1, 2003;
|
|
|
|
(iii) Item 0004A and
0004B is from April 11, 2002 to August 1, 2003.
|
|
|
(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 August 1, 2003.
|
|
|
(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.
|
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:
|
|
|
|
|
|
|
|
|
(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
|
|
|
|
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).
|
|
|
|
|
(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. The number of manufacturing
facility change-overs that may be ordered under Items 0003A and
0003B is dependent on the number of separate campaigns of filled
product the Buyer utilizes under Item 0002. Buyer will order one
(1) change over for each different product (e.g., ACAM 2000 or ACAM
1000) ordered under Item 0002. Order of change-over under ITEM
0003A is subject to Government approval.
|
|
|
|
|
|
|
|
ITEM 0004A – There
is no guaranteed minimum quantity of diluent that the Buyer will
order under Item 0004. Buyer may order diluent to accompany IND
ACAM 1000 under Buyer’s prime contract 200-2000-00001 with
the U.S Government. Any orders under Item 0004A may be issued to
Manufacturer in Buyer’s sole discretion and are subject to
U.S. Government approval.
|
|
|
|
|
|
|
|
ITEM 0004B – The
guaranteed minimum quantity of diluent to accompany IND ACAM 2000
vaccine is 1,550,000 vials.
|
|
|
|
|
|
|
|
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 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
– From Contract Award until August 1, 2003
|
|
|
|
|
|
|
|
|
(ii)
|
Items 0004A and 0004B
− From Contract Award until August 1, 2003
|
|
|
|
|
|
|
|
|
(ii)
|
Items 0005A and 0005B and
0006 – From Receipt of BLA until January 31, 2007.
|
|
|
|
|
|
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:
|
|
|
|
|
|
|
(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.
|
|
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.
|
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 April 11, 2002 to September 30,
2002 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. A “ missed fill” occurs whenever Buyer
provides bulk vaccine product to Manufacturer for filling later
than one day after the expected start date for filling as set forth
on Attachment J, Section G such that Manufacturer is unable to
perform two (2) fills per week. In the event that more than five
(5) fills are “missed”, the Buyer may extend the period
of performance for Item 0001A to allow performance of additional
fills to replace the missed filled lots.
|
|
|
|
|
|
|
|
|
(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 1,550,000 vials of ACAM 2000 by
September 30, 2002 as extended for any “missed fills”
as specified in paragraph (a)(i) above . The “partial
fill” fee will be ********** for each additional fill
after September 30, 2002 required to fill 1,550,000 vials of Item
0001A material over and above the number of fills for which the
Manufacturer received a “missed fill” underutilization
fee under paragraph (a)(i) above and the number of fills that
failed due to Manufacturer’s negligence or failure to comply
with good manufacturing practices, batch records, or
Manufacturer’s standard operating procedures. The period of
performance for Item 0001A may be extended by Buyer to add the
additional fills required to complete Item 0001A fill and finish to
make-up for underutilization due to any partial fills.
|
|
|
|
|
|
|
(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 October 1, 2002 to August 1, 2003 to
provide the manufacturing capability required by Item 0002 and to
perform change-over activities under Items 0003A and
0003B.
|
|
|
|
|
|
(b) Guaranteed
Payment. Buyer shall make payments totaling at least the
guaranteed minimum total payment of $4,000,000 for vaccinia vaccine
fills under Item 0002 during the period from October 1, 2002 to
August 1, 2003. If, through Buyer’s failure to provide bulk
vaccine, Manufacturer is unable to fill sufficient vaccinia vaccine
to generate a revenue of at least $4,000,000 under Item 0002 for
filled products delivered from October 1, 2002 to August 1, 2003,
Manufacturer is entitled to a payment measured by the difference
between $4,000,000 and the total amount Manufacturer was paid under
Item 0002. Manufacturer may invoice for any such payments upon
completion of Item 0002.
|
|
|
|
|
|
(c) Advance
Payments. If Buyer fails to provide sufficient vaccinia vaccine
to generate a revenue of at least ********** for each month
from October 1, 2002 to August 1, 2003 for vaccine filled and
delivered under Item 0002 and change-overs under Items 0003A or
0003B, Manufacturer will be entitled to advance payment of a
portion of the guaranteed minimum total payment under Section
H.2(b). Such advance payment(s) will be equal to the difference
between ********** and Manufacturer’s earned revenue
payable under Items 0002, 0003A and/or 0003B for that month. Any
such advance payments shall be applied against future invoices as a
credit to the Buyer whenever Manufacturer’s revenue payable
in such future month(s) under Items 0002, 0003A and/or 0003B
exceeds ********** For example:
|
|
|
|
|
|
|
|
|
|
|
Period
|
Manufacturer’s
|
Advance
|
Buyer’s
|
Manufacturer’s
|
|
|
|
|
Earned
Revenue
|
Payment
|
Credit
|
Invoiced
Amount
|
|
|
|
Month 1
|
**********
|
**********
|
**********
|
**********
|
|
|
|
Month 2
|
**********
|
**********
|
**********
|
**********
|
|
|
|
Month 3
|
**********
|
**********
|
**********
|
**********
|
|
|
|
Month 4
|
**********
|
**********
|
**********
|
**********
|
|
|
|
Month 5
|
**********
|
**********
|
**********
|
**********
|
|
|
|
|
|
|
Manufacturer may invoice
for this advance payment monthly until Manufacturer’s total
revenue under Item 0002 equals the guaranteed minimum payment under
Item 0002 of $4,000,000. Once Manufacturer’s total revenue
under Item 0002 equals or exceeds $4,000,000, Manufacturer shall
not be entitled to further advance payments under this Section
H.4(c) and the then-current amount of advanced payments made shall
be credited to the Buyer on future invoices, as described
above.
|
|
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 anticipated
dates for the fill, lyophilization, and finish of vaccinia vaccine
under Item 0002 will be established after contract award for fill
and finish between October 1, 2002 and August 1, 2003. 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.
Manufacturer shall be paid ********** for each conformance
lot manufactured prior to demonstrating validation of the
manufacturing process. For the three successful consecutive lots
that demonstrate validation of the manufacturing process,
Manufacturer shall also be paid upon completion of the third
successful lot, the difference between the above **********
and the Item 0001A price for the filled vaccine. Thereafter,
Manufacturer shall be paid the Item 0001A price for filled vaccine
that conforms to subcontract requirements. If, after five
attempted fill lots, CBL has been unable to establish validation of
the manufacturing process; the parties shall suspend fill and
finish activity to review the product and the batch
records/manufacturing process to determine what changes may be
required to enable successful manufacture of the
vaccine.
|
|
|
|
|
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
|
|
|
|
|
|
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.
|
|
|
|
|
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
plan shall describe the Manufacturer’s procedures to ensure
against theft, tampering or destruction of the vaccinia vaccine and
diluent and all related documents. This plan shall also protect the
Manufacturer’s physical facilities
**********
|
|
|
|
|
|
|
|
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.
|
|
|
|
|
|
|
(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
|
|
|
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.
|
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. Governm
|
