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AMENDMENT OF
SOLICITATION/MODIFICATION OF CONTRACT
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1.
CONTRACT ID CODE
N/A
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Page
1 of 10
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2.
AMENDMENT/MODIFICATION NO.
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3.
EFFECTIVE DATE
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4.
REQUISITION/PURCHASE REQ. NO
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5.
PROJECT NO. ( If applicable )
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0007
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See Block 16C
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OS8873
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N/A
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6. ISSUED BY
CODE
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N/A
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7.
ADMINISTERED BY (IF OTHER THAN ITEM 6) CODE
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N/A
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U.S. DEPT OF
HEALTH & HUMAN SERVICES
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See Block 6
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330 INDEPENDENCE
AVE SW, ROOM G640
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8. NAME AND
ADDRESS OF CONTRACTOR ( No., Street, County, State and ZIP
Code )
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o
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9A. AMENDMENT OF
SOLICITATION NO.
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Human Genome Sciences,
Inc.
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14200 Shady
Grove Road
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Rockville,
Maryland 20850-7464
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9B. DATED (
SEE ITEM 11 )
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TEL.
301/309.8504
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x
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10A.
MODIFICATION OF CONTRACT/ORDER NO.
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DUNS:
797057437
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HHSO100200500006C
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TIN:
223178468
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CODE:
N/A
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FACILITY CODE: N/A
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10B. DATED (
SEE ITEM 13 ) 9/23/2005
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11. THIS ITEM ONLY APPLIES TO
AMENDMENTS OF SOLICITATIONS
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o
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The
above numbered solicitation is amended as set forth in item 14. The
hour and date specified for receipt of Offers o
is extended,
o
is not
extended.
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Offers must
acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended by one of the following
methods:
(a) By
completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this
amendment on each copy of
the offer submitted; or (c) By separate letter or telegram
which includes a reference to the solicitation and amendment
numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE
PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue
of this amendment, you desire to change an offer already submitted,
such change may be made by telegram or letter, provided each
telegram or letter makes reference to the solicitation and this
amendment, and is received prior to the opening hour and date
specified.
12. ACCOUNTING
AND APPROPRIATION DATA ( If Required )
Appropriation: 75-70-0513-0714-001; Fiscal Year: 2009; CAN:
1993419; Object Class: 26201; Amount +$151,847,100.00
13. THIS ITEM APPLIES ONLY TO
MODIFICATIONS OF CONTRACT/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO.
AS DESCRIBED IN ITEM 14.
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A. THIS CHANGE ORDER IS ISSUED
PURSUANT TO: ( Specify Authority ) THE CHANGES SET FORTH IN
ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
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o
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B. THE ABOVE NUMBERED
CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (
such as changes in paying office, appropriation date, etc. )
SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR
43.103(b).
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x
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C. THIS SUPPLEMENTAL AGREEMENT
IS ENTERED INTO PURSUANT TO AUTHORITY OF: Bilateral Modification at
the Mutual Agreement of the Parties.
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D. OTHER ( Specify type of
modification and authority )
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E.
IMPORTANT: Contractor
o is NOT
x
is required
to sign this document and return 1 copies to the issuing
office.
14. DESCRIPTION
OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where
feasible.)
The purpose of
this modification is to order additional doses of Raxibacumab
(ABthrax TM
) and to add conditions to the
Contract.
Total contract
value increases by $151,847,100 from $176,211,724 to
$328,058,824.
Total funding
allotted to the contract increases by $151,847,100 from
$176,211,724 to $328,058,824.
Contract
expiration date changes by 831 days from 22
September 2010 to 31 December 2012.
[Description
continues on the next page; remainder of this page intentionally
left blank.]
Except as
provided herein, all terms and conditions of the document
referenced in Item 9A or 10A, as heretofore changed, remains
unchanged and in full force and effect.
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15A. NAME AND TITLE OF
SIGNER
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16A. NAME AND
TITLE OF CONTRACTING OFFICER
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James H. Davis – Exec
VP
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[ * * *
]
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15C. DATE
SIGNED
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16B. UNITED
STATES OF AMERICA
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16C. DATE
SIGNED
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/s/ James H.
Davis
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17
Jul 09
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BY
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/s/ [ * * *
]
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17
Jul 09
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( Signature of person authorized
to sign )
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( Signature of Contracting
Officer )
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STANDARD FORM
30 (REV. 10-83)
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Previous
Edition Unusable
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Prescribed by
GSA FAR (48 CFR) 53.243
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[ * * *
]
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INDICATES
MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Human Genome Sciences,
Inc.
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Page 2 of 10
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HHSO100200500006C
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Modification
0007
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[CONTINUATION
OF BLOCK 14 OF SF 30]
This Modification
No. 0007 to Contract No. HHSO100200500006C (this
“Modification”), entered into and made effective as of
the date imprinted in Block 16C of the Standard Form 30, is by
and between the UNITED STATES OF AMERICA, represented by the
Department of Health and Human Services, Biomedical Advanced
Research and Development Authority (the “Government” or
“USG”), and HUMAN GENOME SCIENCES, INC., a Delaware
company, with a principal place of business located at 14200 Shady
Grove Road, Rockville, Maryland 20850 (“HGS” or the
“Contractor”) (USG and HGS hereinafter each being
referred to as a “Party,” and collectively being
referred to as the “Parties”), who jointly agree to be
bound by the terms and conditions hereof,
WHEREAS, HGS is a
biopharmaceutical company that produces Raxibacumab
(ABthrax™), which is a human monoclonal antibody that
specifically targets and blocks Bacillus anthracis
protective antigen; and
WHEREAS, USG
desires to purchase and stockpile therapeutic products to treat
persons with inhalational anthrax disease; and
WHEREAS, USG
desires to maintain manufacturing facilities for anthrax
therapeutic products in compliance with current Good Manufacturing
Practices; and
WHEREAS, USG and
HGS are Parties to an existing contract, which contract is
identified in Block 10 of the Standard Form 30 (the
“Contract”), originally awarded on 23
September 2005 for the purposes of supplying the Strategic
National Stockpile (“SNS”) with a therapeutic product
to treat inhalational anthrax disease; and
WHEREAS, HGS
delivered 20,001 doses of Raxibacumab (ABthrax™) to the SNS
between 29 January 2009 and 5 May 2009 in satisfaction of the
quantity theretofore ordered under Contract Line Item Number
(CLIN) 0003A; and
WHEREAS, HGS
submitted a Biologics License Application on 13 May 2009 to
the Center for Drug Evaluation and Research in the Food and Drug
Administration for the purposes of requesting permission to
introduce Raxibacumab (ABthrax™) into interstate commerce;
and
WHEREAS, USG and
HGS wish to modify the Contract to require HGS to furnish
additional doses of Raxibacumab (ABthrax™) under such
conditions as are more specifically hereinafter set
forth.
NOW, THEREFORE, in
consideration of the mutual promises and other good and valuable
consideration contained herein, the receipt and sufficiency of
which is hereby acknowledged, each Party, intending to be legally
bound, hereby agrees as follows:
1. Contract
section B.6 entitled Contract Line Item Numbers (CLINs)
is changed by adding the following to the end of the
table:
Definitions : “CLIN” shall mean Contract Line
Item Number; “Qty” shall mean Quantity;
“U/I” shall mean Unit of Issue; “NTE” shall
mean Not-to-Exceed; “NSP” shall mean Not Separately
Priced.
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Unit
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Extended
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CLIN
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Item
Description
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Qty
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U/I
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Price
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Value
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Raxibacumab
(ABthrax™)
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15,000
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Doses
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[ * * * ]
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[ * * * ]
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This is a
firm-fixed price line item.
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Raxibacumab
(ABthrax™)
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15,000
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Doses
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[ * * * ]
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[ * * * ]
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This is a
firm-fixed price line item
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Raxibacumab
(ABthrax™)
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15,000
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Doses
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[ * * * ]
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[ * * * ]
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This is a
firm-fixed price line item.
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[ * * *
]
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INDICATES
MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Modification
0007
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HHSO100200500006C
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Human Genome Sciences,
Inc.
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Page 2 of 10
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Human Genome Sciences,
Inc.
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Page 3 of 10
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HHSO100200500006C
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Modification
0007
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Unit
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Extended
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CLIN
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Item
Description
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Qty
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U/I
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Price
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Value
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Re-labeling of
Raxibacumab (ABthrax™)
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NTE
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Doses
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[ * * * ]
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[ * * * ]
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stored in SNS
from investigative material
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45,000
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to FDA-licensed
product.
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FDA-licensure
of Raxibacumab (ABthrax™)
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15,000
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Doses
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[ * * * ]
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[ * * * ]
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This is a
firm-fixed price line item.
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FDA-licensure
of Raxibacumab (ABthrax™)
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15,000
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Doses
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[ * * * ]
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[ * * * ]
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This is a
firm-fixed price line item.
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FDA-licensure
of Raxibacumab (ABthrax™)
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15,000
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Doses
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[ * * * ]
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[ * * * ]
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This is a
firm-fixed price line item.
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2. Contract
part I entitled The Schedule is changed by adding the
following conditions to the stated sections:
B.8.1.
Regulatory Fees . The contract price is inclusive of all
regulatory fees, including, but not limited to, the BLA Submission
User Fee costs associated with the Prescription Drug User Fee Act
(PDUFA) for submittal of a BLA to FDA.
B.8.2.
People in Plant . The USG may place, for a duration of its
choosing, one or two persons in the Contractor’s facility
(including the facilities of the current fill/finish subcontractor
(the “Fill/Finish Subcontractor”), if permitted by
Contractor’s agreement with such subcontractor) during
manufacturing of the Products (as defined below) with a five
(5) business day advance notice to Contractor. The People in
Plant will observe, verify, and survey Contractor’s
performance, environment and adherence to the Scope of Work and
applicable regulations under this contract. Contractor shall use
its best efforts to include the terms and conditions of this clause
in the fill/finish subcontract, so that these terms and conditions
will be binding upon such subcontractor; provided that “best
efforts” as used hereunder does not require Contractor to
engage a replacement fill/finish subcontractor if the Fill/Finish
Subcontractor refuses to incorporate such terms and conditions in
its contract with Contractor.
B.8.3.
Site Visits, Audits, & Collection of Samples
.
B.8.3.1.
At the sole discretion of the USG, and independent of testing
conducted by Contractor, the USG (or contractor(s) retained by USG)
may conduct site visits, audits, and sample collections of any
material, intermediates, work-in-process material, bulk drug
substance or Products at the facilities of Contractor or the
Fill/Finish Subcontractor (if permitted by Contractor’s
agreements with such subcontractor) or in the Strategic National
Stockpile (“SNS”); provided that USG provides a five
(5) business day advance written notice; provided further that
any requirement for notice shall not apply in the event of an
emergency as determined by the USG. Contractor shall furnish all
information, facilitation, and assistance necessary to allow for
safe and convenient site visits, audits, and sample collections.
Contractor shall, at its sole expense, take all corrective action
in a timely manner necessary to develop, modify, and maintain its
systems, plans and procedures in accordance with the USG’s
requirements. Contractor shall use its best efforts to include the
terms and conditions of this clause in the fill/finish subcontract,
so that these terms and conditions will be binding upon such
subcontractor; provided that “best efforts” as used
hereunder does not require Contractor to engage a replacement
fill/finish subcontractor if the Fill/Finish Subcontractor refuses
to incorporate such terms and conditions in its contract with
Contractor.
B.8.3.2.
Site visits, audits, and sample collections may include, but are
not limited to, the following areas: shipping, security,
regulatory, quality, GMP/GLP/GCP compliance, facilities, storage,
records, testing, and manufacture.
B.8.4.
Timely Manufacture . In the event of a termination for convenience or
Change, no claim for reimbursement by Contractor will be allowed
for any manufacture or procurement in advance of Contractor’s
normal flow time unless there has been prior written consent by the
Contracting Officer.
B.8.5.
Product Replacement . Product accepted by the USG, but that later
falls into any of the following three categories, shall be replaced
by Contractor at no cost to the USG.
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[ * * *
]
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INDICATES
MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Modification
0007
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HHSO100200500006C
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Human Genome Sciences,
Inc.
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Page 3 of 10
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Human Genome Sciences,
Inc.
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Page 4 of 10
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HHSO100200500006C
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Modification
0007
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(a) Product
does not meet any specified label claims, fails release testing, or
does not meet at a minimum a twenty-four (24) month expiry
period.
(b) Product
is deemed to be recalled for any reason, as outlined in Product
Recalls, Including Removals and Corrections published by U.S.
Department of Health and Human Services, Food and Drug
Administration, Office of Regulatory Affairs; or based upon
Chapter 7 of the Regulatory Procedures Manual of
March 2007.
(c) Product
is different from the final FDA-approved or licensed
product.
B.8.6.
Access to Documentation . The USG shall have physical and electronic
access, upon request, to all documentation and data generated
during this contract, including but not limited to: all Contractor
efforts; communications and correspondence with regulatory agencies
and bodies to include all audit observations, inspection reports,
and all Contractor’s commitments and responses. At the
request of the USG, the Contractor shall provide all information of
this nature generated under previous USG-funded efforts.
C.6.
Storage and cGMP Stability Programs .
Contractor shall store the products
listed in paragraphs (a), (b), and (c) below (the
“Products”) in a U.S. facility and, in consultation
with FDA and CDC, establish, perform, and maintain separate
stability programs for each of the Products for a minimum of sixty
(60) months beginning on the date of lot release pursuant to
FDA cGMP storage and stability guidelines and requirements.
Contractor stability programs shall be designed and implemented to
maximize the quality and useful life of the Products.
(a) Bulk Drug
Substance (“BDS”)
(b) Final
Drug Product (“FDP”)
C.7.1. Contractor shall develop a labeling strategy in
consultation with FDA and CDC that transitions FDP labels from IND
to licensed product. The labeling strategy shall be submitted to
FDA/CDER for its complete review and concurrence.
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