exv10w1





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 Offerso 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 (ABthraxTM) 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.


















 





			
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	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 (ABthraxTM), 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 (ABthraxTM) 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 (ABthraxTM) into interstate commerce; and



     WHEREAS, USG and HGS wish to modify the Contract to require HGS to furnish additional doses of
Raxibacumab (ABthraxTM) 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 (ABthraxTM)	 	15,000	 	Doses	 	[ * * * ]	 	[ * * * ]
	 
	 	This is a firm-fixed price line item.	 	 	 	 	 	 	 	 
	 
	0010
	 	Raxibacumab (ABthraxTM)	 	15,000	 	Doses	 	[ * * * ]	 	[ * * * ]
	 
	 	This is a firm-fixed price line item	 	 	 	 	 	 	 	 
	 
	0011
	 	Raxibacumab (ABthraxTM)	 	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.





			
	 
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	Human Genome Sciences, Inc.
	 	Page 2 of 10






 









 





			
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	 	 	 	 	 	 	 	 	Unit	 	Extended
	CLIN	 	Item Description	 	Qty	 	U/I	 	Price	 	Value
	0012
	 	Re-labeling of Raxibacumab (ABthraxTM)	 	NTE	 	Doses	 	[ * * * ]	 	[ * * * ]
	 
	 	stored in SNS from investigative material 	 	45,000	 	 	 	 	 	 
	 
	 	to FDA-licensed product.	 	 	 	 	 	 	 	 
	 
	0013
	 	FDA-licensure of Raxibacumab (ABthraxTM)	 	15,000	 	Doses	 	[ * * * ]	 	[ * * * ]
	 
	 	This is a firm-fixed price line item.	 	 	 	 	 	 	 	 
	 
	0014
	 	FDA-licensure of Raxibacumab (ABthraxTM)	 	15,000	 	Doses	 	[ * * * ]	 	[ * * * ]
	 
	 	This is a firm-fixed price line item.	 	 	 	 	 	 	 	 
	 
	0015
	 	FDA-licensure of Raxibacumab (ABthraxTM)	 	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.





			
	 
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	HHSO100200500006C	 	 
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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) 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. For additional information on labeling, Contractor should consult the interim final
rule “Exceptions or Alternatives to labeling Requirements for Products held by the Strategic
National Stockpile,” which document was published in the Federal register as Docket No. 2006N-0466
on December 28, 2007, available at http://edocket.access.gpo.gov/2007/pdf/e7-25165.pdf.
Contractor understands that an interim rule is open to public comment and future modification by
the USG.


C.8. Government Contractors. To the extent required for performance of the contract, the
Contractor shall fully cooperate with other USG contractors in the execution of this contract as
directed by the Contracting Officer, excluding other contractors that manufacture an anthrax
antitoxin, provided the USG takes all reasonable steps to protect confidential and proprietary
information in accordance with all applicable laws and regulations. USG anticipates that
Contractor may receive information and/or material that are confidential and proprietary to private
entities directly from those private entities in order to fulfill the requirements in this
contract. As the Contracting Officer deems necessary, the Contracting Officer may direct
Contractor to promptly negotiate appropriate agreements with the private entities governing the use
of such information and material in accordance with this contract, other applicable agreements, and
applicable law; provided that Contractor is not required to enter into such agreements if such
private entities refuse to do so. Any such agreements must be submitted to the Contracting Officer
for review prior to their execution.



D.2. Packaging of Product. Contractor shall package any Product for delivery under this
Contract in accordance with FDA-approved labeling and packaging for the Product. Packaging shall
be designed to promote, maximize, and maintain product quality during long-term
temperature-controlled storage at the SNS.




	 	 	 
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	HHSO100200500006C	 	 
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F.4. Batch Records. Contractor shall provide all batch records for the FDP lots
manufactured under this contract to the Contracting Officer upon demand.



F.5. Product Transport and Delivery.




     F.5.1. BARDA must approve all plans and standard operating procedures related to the
transport, delivery and acceptance of Product prior to delivery of FDP to the SNS. Such plans and
procedures include, but are not limited to: qualification and validation plans for
temperature-controlled packaging of Product to ensure it meets the acceptance criteria before
delivery to the SNS; qualification of vehicles and shipping procedures, instructions, choice of
temperature recording methods and procedures for handling deviations and excursions.



     F.5.2. Contractor shall, at its sole expense, take all corrective action necessary to develop,
modify, and maintain its product transport and delivery plans and procedures in accordance with the
USG’s requirements.


F.6. Interactions with Regulatory Agencies. The obligations set forth in this paragraph
shall apply with respect to interactions with regulatory agencies.




     (a) The Contractor shall prepare and submit initial draft minutes and final accepted minutes
of all informal and formal meetings with U.S. regulatory agencies, to include FDA, to BARDA.



     (b) The Contractor shall forward the dates and times of all scheduled meetings with U.S.
regulatory agencies, to include FDA, to BARDA and make arrangements for appropriate BARDA staff to
attend such U.S. regulatory agencies meetings in person and via teleconference.



     (c) The Contractor shall provide BARDA the opportunity to review and comment upon any
documents to be submitted to U.S. regulatory agencies with the exception of documents that are
administrative in nature. The Contractor shall provide BARDA with three (3) business days, or such
shorter period as may be practicable in time-sensitive situations, to review and provide comments
to the Contractor prior to its submittal to U.S. regulatory agencies.



     (d) The Contractor shall furnish all findings of U.S. regulatory agencies inspections,
including FDA form 482 and 483 inspection notice and observations and Establishment Inspection
Reports (EIR) pertinent to the contract, to BARDA within forty-eight (48) hours of receipt.



     (e) The Contractor shall notify the USG of all site visits/audits by U.S. regulatory agencies,
including FDA, within twenty-four (24) hours of agency personnel’s arrival.



     (f) The Contractor shall forward the dates and times of all unscheduled meetings with U.S.
regulatory agencies, including FDA, within twenty-four (24) hours of such meetings.


F.7. Inventory Reports. The Contractor shall provide the USG with monthly inventory reports
of all BDS and FDP in storage. Inventories reported shall be current as of the last working day of
the month, and submitted within fifteen (15) days following the end of said month, unless otherwise
directed by the Contracting Officer. The report shall provide the following information for each
lot:




     (a) Lot Number



     (b) Anticipated, or actual FDA-approved, Expiration Date, as applicable



     (c) Number of Doses


F.8. Timely Delivery of FDP. Contractor shall only deliver FDP that was filled/finished and
packaged no longer than six (6) months prior to said delivery.



F.9. Shipping Temperature Monitoring Devices. Contractor shall furnish and utilize
temperature monitoring devices in all shipments of FDP to the SNS. Contractor must only furnish
and utilize temperature monitoring devices that are compatible with the temperature monitoring
hardware and software at any SNS location. Contractor understands and agrees




	 	 	 
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	HHSO100200500006C	 	 
	Human Genome Sciences, Inc.
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that each SNS
location may use different temperature monitoring hardware and software. Contractor further
understands and agrees that the SNS may change the temperature monitoring hardware and software at
anytime without notice to Contractor.



F.10. Timely Delivery. Unless advance shipment has been authorized in writing by the
Contracting Officer, the USG may store at Contractor’s expense, or return, shipping charges
collect, all Products received in advance of the scheduled delivery date.



F.11. Dates for FDP Delivery. Contractor shall deliver FDP according to the schedule and
limitations set forth in the table below; provided that Contractor may deliver a variation in
Quantity of Doses of plus or minus (+/-) 20% of the stated Quantity of Doses on each Delivery Date;
provided further that no more than 15,000 doses shall be delivered and invoiced under each CLIN.
Except as otherwise authorized by this Contract, in no event shall more than 45,000 doses be
delivered and invoiced under this Contract. The number of deliveries to the SNS shall not exceed
three (3) per calendar quarter; provided that deliveries shall not occur more frequently than once
every thirty (30) days, unless otherwise approved by the Contract Officer in writing.
Notwithstanding the foregoing and the table below, any shipments and dose quantities must be
approved and authorized by the Contracting Officer in writing prior to delivery to the SNS.




	 	 	 	 	 	 	 	 	 
	 
	 	CLIN	 	 	Quantity of Doses	 	 	Delivery Date	 
	 	0009	 	 	 	 	 	 	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	CLIN
	 	 	Number of Doses
	 	 	Delivery Date	 
	 	0010	 	 	 	 	 	 	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	CLIN
	 	 	Number of Doses
	 	 	Delivery Date	 
	 	0011	 	 	 	 	 	 	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 	 
	 	 	[ * * * ]
	 	 	[ * * * ]	 
	 







F.12. Notice of Difficulties. Separately and in addition to any other requirement for
notice or report, if Contractor becomes aware of difficulty in performing the work under this
contract, Contractor shall timely notify USG, in writing, giving pertinent details. This
notification will not change the delivery schedule set forth above.



F.13. Time of the Essence. Contractor’s timely performance is a critical element of this
Contract. Time is of the essence in the performance of all obligations under this Contract.



G.10. Contract Communications and Correspondence.




             (a)
Contractor shall identify all correspondence, reports, and other data pertinent to this
contract by imprinting thereon the contract number from Page 1 of this contract.



             (b)
Any notice required or otherwise given pursuant to this Contract shall be in writing.



             (c)
Any notice to the USG shall be addressed to the Contracting Officer; any notice to the
Contractor shall be to the addressee indicated on the execution page of this Contract.





 




		
	[ * * * ]	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 6 of 10







 











 





			
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H.26.  Miscellaneous.




     (a) Any and all provisions, promises and warranties contained herein which by their terms,
nature or effect are required or intended to be observed, kept or performed after termination or
expiration of this contract will survive the termination or expiration of this Agreement, as the
case may be, and remain binding upon and for the benefit of the Parties hereto.



     (b) This contract contains the complete, entire, exclusive, and final understanding of the
Parties with respect to the subject matter hereof and supersedes all prior negotiations,
representations or contracts, either written or oral, regarding this subject matter. No promise,
warranty or agreement has been made by either Party that is not set forth herein. No subsequent
modification to this contract shall be binding unless in writing and signed by the Parties hereto.



     (c) This contract may be executed and delivered by any means and in any number of
counterparts, each of which shall be an original as against either Party whose signature appears
thereon, but all of which taken together shall constitute but one and the same instrument.



     (d) Each clause, paragraph and subparagraph of this contract is severable. If any provision
of this contract is determined to be illegal or unenforceable, then this contract will remain in
effect and such provision will be enforced to the maximum extent possible with all other provisions
remaining fully effective and enforceable, unless such reduced enforceability or omission of such
provision would frustrate the intent of the Parties, in which case this contract will immediately
terminate.



     (e) Any failure, forbearance or delay in insisting upon or enforcing any provisions of this
contract or applicable law, or in exercising a party’s rights, remedies, powers, or privileges
under this contract, shall neither excuse the other party from performance of any obligations under
this contract or law, nor be construed as a waiver or relinquishment of any of the requirements of
such provisions, rights or remedies of the enforcing party under the contract or law; rather the
same shall remain in full force and effect and neither party shall thereafter be precluded from or
impaired in any further enforcement of any provision under this contract or law. Each party’s
rights and remedies under this contract shall not be exclusive, but rather shall be in addition to
any other rights and remedies provided by law, this contract, or in equity.



     (f) The captions to the several Articles, Paragraphs, and sub-Sections of this contract are
not a part of this contract, but are merely for convenience to assist in locating and reading the
several Articles, Paragraphs, and sub-Sections of this contract.



H.27. Government Approvals. Contractor agrees that any and all USG reviews or approvals of
Contractor’s technical specifications, quality specifications, methodologies, drawings, plans,
procedures, validations, protocols, regulatory agency submissions, and reports shall not relieve
Contractor from Contractor’s obligations to comply with and perform all of the requirements of this
contract.




H.28. Cooperation with Government Contractors.




     (a) As directed by the USG, Contractor shall cooperate under this Contract in a complementary,
responsive and timely manner with other persons or entities that may be retained by the USG;
provided that Contractor will not be required to cooperate or share information pursuant to this
paragraph with other contractors that manufacture an anthrax antitoxin and the USG has taken all
reasonable steps to protect the Contractor’s confidential information under applicable law and
regulation.



     (b) Other entities are not authorized to direct Contractor in any manner.



     (c) The USG’s contracts with other entities will contain a confidentiality/non-disclosure
clause that requires said contractors to protect shared information and prohibits such contractors
from using the information for any purpose other than that for which the information was furnished.



			
	 
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     (d) Neither the Contractor nor its subcontractors shall be required in the satisfaction of the
requirements of this paragraph to perform any effort or supply any documentation not otherwise
required by this contract or subcontract.



     (e) The Contractor agrees to include this clause in its contract with the Fill/Finish
Subcontractor; provided that Contractor is not required to include such clause if the Fill/Finish
Subcontractor refuses to do so. This agreement neither relieves the Contractor of responsibility
to manage subcontracts effectively and efficiently, nor is it intended to establish privity of
contracts between the USG or other entities and such subcontractors.



H.29. Release of Contractor Confidential Information.




     (a) The Department of Health and Human Services (“HHS”) may find it necessary to release
information submitted by the Contractor pursuant to the provisions of this contract, to individuals
not employed by HHS with whom HHS has entered into confidentiality/non-disclosure agreements.
Information that is ordinarily entitled to confidential treatment under applicable law may be
included in the information released to these individuals. Accordingly, by signature on this
contract or other contracts, Contractor hereby consents to a limited release of its confidential
information (“CI”) provided that such information is not released to other companies that
manufacture an anthrax antitoxin.



     (b) Possible circumstances where HHS may release the Contractor’s CI to entities that are
under confidentiality/non-disclosure agreements with HHS include, but are not limited to, the
following:


          (1) To HHS support service contractors tasked with assisting HHS in the administration,
evaluation, audit, or handling and processing information and documents in the award,
administration, or termination of HHS contracts.


          (2) To entities such as the Government Accountability Office, boards of contract appeals, and
courts of competent jurisdiction in the resolution of solicitation or contract protests and
disputes.


          (3) To HHS contractor employees engaged in information systems analysis, development,
operation, and maintenance, including performing data processing and management functions for HHS.


          (4) Pursuant to a court order or court-supervised agreement.



     (c) HHS recognizes an obligation to protect the Contractor from competitive harm that may
result from the release of CI to a competitor. Except where otherwise provided by law, HHS will
only permit the release of CI pursuant to a confidentiality/non-disclosure agreement.



     (d) This clause does not authorize HHS to release the Contractor’s CI to the public pursuant
to a request filed under the Freedom of Information Act.



     (e) The Contractor agrees to include this clause, including this paragraph (e), in all
subcontracts at any tier awarded pursuant to this contract that require the furnishing of
confidential business information by the subcontractor.



H.30. Conflict of Interest. The Contractor represents and warrants that, to the best of the
Contractor’s knowledge and belief, there are no relevant facts or circumstances which could give
rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, or that the
Contractor has disclosed all such relevant information. Prior to commencement of any work, the
Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and
belief, no actual or potential conflict of interest exists or to identity to the Contracting
Officer any actual or potential conflict of interest the firm may have. In emergency situations,
however, work may begin but notification shall be made within five (5) working days. The
Contractor agrees that if an actual or potential organizational conflict of interest is identified
during performance, the Contractor shall promptly make a full disclosure in writing to the
Contracting Officer. This disclosure shall include a description of actions, which the Contractor
has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate,
or neutralize the actual or potential conflict of interest. The Contractor shall continue
performance until notified by the Contracting Officer of any contrary action to be taken. Remedies
include termination of this contract for convenience, in whole or in part, if the Contracting
Officer deems such termination necessary to avoid an organizational conflict of interest. If the
Contractor was aware of a potential organizational conflict of interest prior to award or




			
	 
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discovered an actual or potential conflict after award and did not disclose it or
misrepresented relevant information to the Contracting Officer, the Government may terminate the
contract for default, debar the Contractor from Government contracting, or pursue such other
remedies as may be permitted by law or this contract.




H.31. Confidentiality of Information.




     (a) The USG has determined that this contract involves access to, and creation, distribution,
and use of, sensitive information, confidential information, and other non-public information
(“Protected Data/Materials”). Non-public information is information, data, paperwork, records,
electronic media, material or similar items that is known, or reasonably should be known, not to
have been made available to the general public. USG agrees to mark all Protected Data/Materials
that are provided to Contractor. Contractor shall mark all Protected Data/Materials created by
Contractor. Examples of Protected Data/Materials include, but are not limited to,
information/data/materials/et cetera that is:


          (1) routinely exempt from disclosure under 5 U.S.C. 552 or otherwise protected from disclosure
by statute, Executive order or regulation;


          (2) designated as non-public by any government agency;


          (3) has not actually been disseminated to the general public and is not authorized to be made
available to the public on request; or


          (4) not independently developed by Contractor without benefit of Protected Data/Materials.



     (b) Contractor shall maintain confidentiality of Protected Data/Materials, and shall not
release, publicize, or make known such Protected Data/Materials in any manner. Further, Contractor
agrees to use such Protected Data/Materials only under the following conditions:


          (1) Contractor shall



               (i) use Protected Data/Materials only for the purposes of carrying out the work required by
the contract;



               (ii) not disclose Protected Data/Materials to anyone other than the Contracting Officer, his
duly appointed project officer(s), or as otherwise authorized under this contract; and



               (iii) return Protected Data/Materials whenever the information/data/material is no longer
required by the Contractor for performance or upon completion of the contract, whichever is sooner;
provided, however, Contractor may retain one copy in its legal files for verification, compliance
and dispute resolution purposes.


          (2) Contractor shall obtain written confidentiality/non-disclosure agreements to honor the
limitations of this clause from each of the Contractor’s employees who will have access to
Protected Data/Materials before the employee is allowed access.


          (3) Contractor agrees that these contract conditions concerning the use and disclosure of such
Protected Data/Materials are included for the benefit of, and shall be enforceable by, the
Government and any affected person, business, or organization having a proprietary interest in the
information/data/material.


          (4) Contractor shall not use any Protected Data/Materials to compete with any person,
business, or organization having a proprietary interest in the Protected Data/Materials.


          (5) The Contractor agrees to obtain the written consent of the Contracting Officer prior to
entering into any subcontract that will involve the disclosure of Protected Data/Materials by the
Contractor to the subcontractor.



			
	 
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          (6) If Contractor, through an employee or otherwise, is subpoenaed to testify or produce
documents, or to disseminate any Protected Data/Materials to comply with any law, rule, regulation,
court ruling or similar order, which could result in disclosure of such Protected Data/Materials,
then the Contractor must provide immediate advance notification to the contracting officer so that
the Government may authorize such disclosure, or have the opportunity to take action to prevent
such disclosure.



     (c) Contractor shall submit any request for waiver of this provision to the Contracting
Officer. Disclosure of any Protected Data/Materials, in whole or in part, by Contractor shall only
be made after receipt of signed, written approval from the Contracting Officer. Whenever the
Contractor is uncertain with regard to the proper handling of Protected Data/Materials under the
contract, Contractor shall obtain a written determination from the Contracting Officer.



     (d) The Contractor agrees that this provision is a substantive and material part of this
contract and that any disclosure of Protected Data/Materials other than as provided under this
contract is in violation of this contract and maybe a violation of applicable law. Remedies for
noncompliance herewith include default, or other contractual actions, as well as civil or criminal
remedies authorized by law.



     (e) The requirements of this clause shall survive the termination or expiration of this
contract and shall continue in perpetuity.



     (f) The Contractor agrees to include a clause substantially the same as this clause in its
contract with the Fill/Finish Subcontractor; provided that Contractor is not required to include
such clause if the Fill/Finish Subcontractor refuses to do so.



[End of Paragraph 2]



     The Representations, Certifications and Other Statements of Contractor submitted prior to the
execution of this Modification are hereby incorporated herein by reference with the same force and
effect as if they were given in full text. Contractor acknowledges that the USG will rely upon
Contractor certifications and representations contained in this clause and in any written offer,
proposal or quote, representation, or company profile that was made or provided to the USG by
Contractor and which served as the basis of the award of this Modification to Contractor.
Contractor acknowledges and agrees that any representation, certification, and other statement
contained in this clause is now a substantive part of this Contract and each is a condition of this
Contract.



     This Modification, together with the Contract, contains the complete, entire, exclusive, and
final understanding of the Parties with respect to the subject matter hereof and supersedes all
prior negotiations, representations or contracts, either written or oral, regarding this subject
matter. No promise, warranty or agreement has been made by either Party that is not set forth
herein. No subsequent modification to this contract shall be binding unless in writing and signed
by the Parties hereto.



     The Parties agree and acknowledge that the form of expression of each condition of this
Modification was the subject of negotiation and bargaining between the Parties.



     This Modification may be executed and delivered by any means and in any number of
counterparts, each of which shall be an original as against either Party whose signature appears
thereon, but all of which taken together shall constitute but one and the same instrument.



[END OF MODIFICATION 0007]




			
	 
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