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AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Addendum or Modifications

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT | Document Parties: HUMAN GENOME SCIENCES INC | HEALTH & HUMAN SERVICES | HUMAN GENOME SCIENCES, INC You are currently viewing:
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HUMAN GENOME SCIENCES INC | HEALTH & HUMAN SERVICES | HUMAN GENOME SCIENCES, INC

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Title: AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
Date: 10/29/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT, Parties: human genome sciences inc , health & human services , human genome sciences  inc
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Exhibit 10.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

 

  1. CONTRACT ID CODE
  N/A

 

  Page 1 of 10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. AMENDMENT/MODIFICATION NO.

 

  3. EFFECTIVE DATE

 

  4. REQUISITION/PURCHASE REQ. NO

 

  5. PROJECT NO. ( If applicable )

 

 

0007

 

   See Block 16C

 

  OS8873

 

  N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6. ISSUED BY CODE

 

  N/A

 

  7. ADMINISTERED BY (IF OTHER THAN ITEM 6) CODE

 

  N/A

 

 

U.S. DEPT OF HEALTH & HUMAN SERVICES

 

 

 

   See Block 6

 

 

 

 

OS\ASPR\BARDA

 

 

 

 

 

 

 

 

 

 

 

 

 

 

330 INDEPENDENCE AVE SW, ROOM G640

 

 

 

 

 

 

 

 

 

 

 

 

 

 

WASHINGTON, D.C. 20201

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8. NAME AND ADDRESS OF CONTRACTOR ( No., Street, County, State and ZIP Code )

 

o

 

9A. AMENDMENT OF SOLICITATION NO.

 

 

Human Genome Sciences, Inc.

 

 

 

 

 

 

 

 

 

 

14200 Shady Grove Road

 

 

 

 

 

 

Rockville, Maryland 20850-7464

 

 

 

9B. DATED ( SEE ITEM 11 )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TEL. 301/309.8504

 

x

 

10A. MODIFICATION OF CONTRACT/ORDER NO.

 

 

DUNS: 797057437

 

 

 

HHSO100200500006C

 

 

TIN: 223178468

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CODE: N/A

 

  FACILITY CODE: N/A

 

 

 

10B. DATED ( SEE ITEM 13 ) 9/23/2005

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

 

 

 

 

 

 

 

 

 

 

 

 

o

 

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.

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.

 

o

 

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.

 

 

 

o

 

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).

 

 

 

x

 

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: Bilateral Modification at the Mutual Agreement of the Parties.

 

 

 

o

 

D. OTHER ( Specify type of modification and authority )

 

 

 

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   15A. NAME AND TITLE OF SIGNER

 

 

 

 

 

 

16A. NAME AND TITLE OF CONTRACTING OFFICER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   James H. Davis – Exec VP

 

 

 

 

 

 

[ * * * ]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   15B. CONTRACTOR/OFFEROR

 

  15C. DATE SIGNED

 

 

16B. UNITED STATES OF AMERICA

 

  16C. DATE SIGNED

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

   BY

 

/s/ James H. Davis

 

  17 Jul 09

 

 

BY

 

/s/ [ * * * ]

 

  17 Jul 09

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

( Signature of person authorized to sign )

 

 

 

 

 

 

 

 

 

 

( Signature of Contracting Officer )

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NSN 7540-01-152-8070

 

STANDARD FORM 30 (REV. 10-83)

Previous Edition Unusable

 

Prescribed by GSA FAR (48 CFR) 53.243

 

[ * * * ]  

 

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.


 

Human Genome Sciences, Inc.

 

Page 2 of 10

HHSO100200500006C

 

 

Modification 0007

 

 

[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,

     WITNESSETH THAT,

     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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unit

 

Extended

CLIN

 

Item Description

 

Qty

 

U/I

 

Price

 

Value

0009

 

Raxibacumab (ABthrax™)

 

15,000

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

This is a firm-fixed price line item.

 

 

 

 

 

 

 

 

 

0010

 

Raxibacumab (ABthrax™)

 

15,000

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

This is a firm-fixed price line item

 

 

 

 

 

 

 

 

 

0011

 

Raxibacumab (ABthrax™)

 

15,000

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

This is a firm-fixed price line item.

 

 

 

 

 

 

 

 

 

[ * * * ]

 

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.

 

 

Modification 0007

 

 

HHSO100200500006C

 

 

Human Genome Sciences, Inc.

 

Page 2 of 10

 


 

Human Genome Sciences, Inc.

 

Page 3 of 10

HHSO100200500006C

 

 

Modification 0007

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unit

 

Extended

CLIN

 

Item Description

 

Qty

 

U/I

 

Price

 

Value

0012

 

Re-labeling of Raxibacumab (ABthrax™)

 

NTE

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

stored in SNS from investigative material

 

45,000

 

 

 

 

 

 

 

 

to FDA-licensed product.

 

 

 

 

 

 

 

 

 

0013

 

FDA-licensure of Raxibacumab (ABthrax™)

 

15,000

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

This is a firm-fixed price line item.

 

 

 

 

 

 

 

 

 

0014

 

FDA-licensure of Raxibacumab (ABthrax™)

 

15,000

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

This is a firm-fixed price line item.

 

 

 

 

 

 

 

 

 

0015

 

FDA-licensure of Raxibacumab (ABthrax™)

 

15,000

 

Doses

 

[ * * * ]

 

[ * * * ]

 

 

This is a firm-fixed price line item.

 

 

 

 

 

 

 

 

[End of Paragraph 1]

     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.

 

[ * * * ]

 

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.

 

 

Modification 0007

 

 

HHSO100200500006C

 

 

Human Genome Sciences, Inc.

 

Page 3 of 10

 


 

Human Genome Sciences, Inc.

 

Page 4 of 10

HHSO100200500006C

 

 

Modification 0007

 

 

     (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) FDA-licensed Product

C.7. Labeling .

           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.

           C.7.2. F


 
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