exv10w5



 





Exhibit 10.5








	1 THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 3501 DF
AWARD/CONTRACT            RATING            PAGE            PAGES 38
——  ——  ——  ——  —
2 CONTRACT (Ptoc Inst Mem ) NO
HS0100200500006C 3 EFFECTIVE DATE 4 REQUISITION/PURCHASE REQUEST/PROJECT NO
——  ——  —
0 ISSUED BY            CODE 6 ADMINISTERED BY (IF other than Item 51 CODE




	SW, Room 636G




	DHHS/OS/OPHEP/ORDC
200 Independence Ave
Washington, DC 20201




	7 NAME AND ADDRESS OF CONTRACTOR (No . street- county. Slats and ZIP Code)




	Human Genome Sciences, Inc.




	14200 Shady Grove Road Rockville, MD 20850




	DUNS 79-705-7437




	8 DELIVERY




	FOB ORIGIN




	OTHER (SEE below!




	9 DISCOUNT FOR PROMPT PAYMENT N/A





	10 SUBMIT INVOICES 4) copies unless other- ITEM
wise specified! TO THE            ADDRESS SHOWN IN 5
CODE            FACILiTY CODE
——  —
11 SHIP TO/MARK FOR 1 2 PAYMENT WILL BE MADE BY            CODE
CODE            See Block 5
See            Block 5
—
1 3 AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 10U S C
2304(c) 41 U S C 253(c) 14 ACCOUNTING AND APPROPRIATION DATA            object
——  —
15A. ITEM NO. 15B. SUPPLIES/SERVICES 15C. QUANTITY 15D.UNIT 15E. UNIT PRICE 15F. AMOUNT
——  ——  ——  ——  ——  —
See            Section B
—
15G. TOTAL AMOUNT OF CONTRACT $
——  —




	16. TABLE OF CONTENTS




	[XI            SEC. DESCRIPTION            PAGE IS! (X) SEC. DESCRIPTION            PAGE(S)
——  ——  ——  ——  ——  ——  ——  —
PART I — THE SCHEDULE            PART II — CONTRACT CLAUSES
——  —
X            A            SOLICITATION/CONTRACT FORM 1 x 1 CONTRACT CLAUSES 34
——  ——  ——  ——  ——  ——  ——  —
x B            SUPPLIES OR SERVICES AND PRICES/COSTS 2 PART III — LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
——  ——  ——  ——  —
X            C            DESCRIPTION/SPECS. /WORK STATEMENT 8 X            J            LiST OF ATTACHMENTS 38
——  ——  ——  ——  ——  ——  ——  —
X            D            PACKAGING AND MARKING 16 PART IV REPRESENTATIONS AND INSTRUCTIONS
——  ——  ——  ——  —
REPRESENTATIONS, CERTIFICATIONS AND OTHER
X            E            INSPECTION AND ACCEPTANCE 17 K            STATEMENTS OF OFFERORS
——  ——  ——  —
X            F            DELIVERIES OR PERFORMANCE 18
——  ——  ——  —
X            G            CONTRACT ADMINISTRATION DATA 21 L 1NSTRS., CONDS., AND NOTICES TO OFFERORS
——  ——  ——  ——  ——  —
X            H            SPECIAL CONTRACT REQUIREMENTS 25 M            EVALUATION FACTORS FOR AWARD
——  ——  ——  ——  ——  —
CONTRACTING OFFICER WILL COM ‘LETEITEM 17 OR 18 AS APPLICABLE
——  —
17 CONTRACTOR S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return 2
copies to issuing office ) Contractor 18 AWARD (Contractor is not required to sign this document) Your offer on Solicitation Number
——  —




	including the additions 01 changes mads by you which additionsTor changes; are set (or!h in
lull above, ts hereby accepted as to the items listed above “andon any condition sheets. This award
consummates thp contract which consists of the iollowing documents: la] the Government’s
solicitation and your oUsr and (ta) this BwaroYcorstract No further contractual document is
necessary




	agrees to furnish and deliver all items or
perform aH the services set forth or otherwise
identified above and on any continuation sheets
for the consideration stated herein The rights
and obligations of the parties to this contract
shall be subject to and governed by the
following documents: la) this award/contract,
fb) the solicitation, if any. and Ic) such
provisions, representations, certifications, and
specifications, as are attached or incorporated
by reference herein /Attachments




	19A NAME AND TITLE OF SIGNER /Type or print! 20A NAME OF CONTRACTING OFFICER
E. Thomas Watkins Chief Executive Officer            Brian K,. Goodger
——  —
''B. NAME OF CONTRACTOR ~- 19C DATE SiGNED 20B UNiTED STATES OF AMERICA 20C DATE SIGNED
        . 9/21/05 by: Brian K. Goodgeo 9/23/05
——  —
(Signature of person authorized to sign! [Signature of Contracting Officer)
——  —




	AUTHORIZED FOR LOCAL REPRODUCTION Previous edition is usable




	STANDARD FORM 26 (REV 12/2002! Prescribed by GSA            FAR (48 CFR) 53 214(a)






 










 








Section B — Supplies Or Services And Prices/Costs



B.1 Description of Services



The Contractor shall supply the necessary supplies and services, for the purchase and maintenance
within the Strategic National Stockpile (SNS), of anthrax therapeutic products to treat United
States (US) civilians with inhalational anthrax disease, in accordance with Section C, Statement of
Work. The United States Government (USG) will purchase Investigational New Drug (IND) Final Drug
Product (FDP), (manufactured under cGMP conditions and described in the IND application to be used
in the Phase I clinical trial) and perform independent comparative testing of products from
prospective Contractor(s) (as described in requirement 1) and conduct an analysis of the
comparative testing results. The USG test information, along with the contractor’s own product/test
data and national security considerations, will form the basis of the USG’s decision process for
additional product acquisition.



B.2 Consideration and Payment (FFP)



In consideration for completion of the work, described under CLINs 0001 & 0002, the Contractor
shall be paid an amount not to exceed $1,797,372.00, in accordance with Section C.5, Requirement 1,
of the Statement of Work.



B.3 Reserved



The
anthrax therapeutic product that is mentioned throughout this
contract is the Contractor’s Protective Antigen monoclonal
Antibody (ABthrax tm)




B.4 Reserved



B.5 Reserved



 




			




2









 








B.6 Contract Line Item Numbers (CLINs)




	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	EXTENDED
	ITEM	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	PRICE
	0001

	 	Final Drug Product (FDP) 


The Contractor shall manufacture
anthrax therapeutic FDP, for use in
testing, in accordance with the
attached Statement of Work. The USG
intends to only pay for costs
associated with the manufacture of
the FDP used for testing. The USG
does not intend to pay for any
costs associated with Research &
Development of the product.
	 	A quantity of FDP
that includes 10
grams of active
pharmaceutical
ingredient	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 
	 

	 	This is a Firm Fixed Price line item	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	0002

	 	Test Support
	 	1 Job
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 
	 

	 	The Contractor shall provide all
necessary labor, effort, supplies
and other necessary items in order
to provide information and other
support services, to aid the
Government in the testing of the
FDP acquired under contract line
item number 0001, in accordance
with the attached Statement of
Work.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	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.




3









 







     B.7 Optional CLINs


Contract Line Item Numbers 0003A — 0008 are Optional. These optional CLINs may be exercised, in
accordance with FAR 52.217-7, (Option for Increased Quantity-Separately Priced Line Item) after USG
testing in CLINs 0001 & 0002 and within 12 months from the date of contract award. Optional CLINs
for Anthrax Therapeutic Products that do not meet a favorable analysis of the comparative testing
results will not be exercised by the USG.




	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0003A

	 	The Contractor
shall manufacture
Anthrax Therapeutic
Product and label
as IND material.


	 	10,000 — 20,000


	 	[***]


	 	[***]


	 

	 	* In accordance
with the Project
Bio-Shield Act of
2004, the
Contractor will be
paid a discounted
price per unit of a
product that is not
licensed, cleared
or approved at the
time of delivery to
the USG as IND
material. The
contractor will be
paid an additional
amount under CLIN
0005 if the product
becomes licensed,
cleared, or
approved by FDA
before the
expiration date of
the contract.


This is a Firm
Fixed-Price Line
Item
	 	20,001 — 30,000


30,001 — 40,000


40,001 — 50,000


50,001 — 60,000


60,001 — 70,000


70,001 — 99,999


100,000


Therapeutic
Courses of Treatment

	 	[***]


[***]


[***]


[***]


[***]


[***]


[***]


	 	[***]


[***]


[***]


[***]


[***]


[***]


[***]







 
 




			
	[***]	 	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.




4









 






	 	 	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES/SERVICES	 	QTY/UNIT	 	EST. COST	 	FIXED FEE	 	TOTAL EST. CPFF
	0003B

	 	Conduct Stability
and Potency
Testing, Advanced
Development/Pivotal
Studies, Submit
Regulatory
Submissions, Ship,
Store, and Dispose
of Product
	 	1 Job
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	The Contractor
shall perform
Stability & Potency
Testing, and
Conduct Advanced
Development/Pivotal
Studies, etc. in
accordance with
Requirements 3-7 of
the attached
Statement of Work.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	This is a Cost Plus
Fixed-Fee Line
Item.	 	 	 	 	 	 	 	 






	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0004

	 	The Contractor
shall execute the
labeling strategy
to convert the
investigative phase
of the label to the
approved/licensed
label, in
accordance with the
attached Statement
of Work.


This is a Firm
Fixed-Price Line
Item.
	 	10,000 — 20,000


20,001 — 30,000


30,001 — 40,000


40,001 — 50,000


50,001 — 60,000


60,001 — 70,000


70,001 — 100,000


Therapeutic
Courses of
Treatment
	 	[***]


[***]


[***]


[***]


[***]


[***]


[***]


	 	[***]


[***]


[***]


[***]


[***]


[***]


[***]







 
 




			
	[***]	 	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.




5









 






	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0005

	 	The Contractor
shall receive
payment, for
Anthrax Therapeutic
Product labeled as
FDA
approved/licensed
material, in
accordance with the
attached Statement
of Work.


The USG will
authorize an
additional payment
to the Contractor
once the
therapeutic courses
of treatment are
finalized as FDA
approved/licensed
material in
accordance with the
discounted payment
description in CLIN
0003A above.


This is a Firm
Fixed-Price Line
Item.
	 	10,000 — 20,000 


20,001 — 30,000


30,001 — 40,000


40,001 — 50,000 


50,001 — 60,000


60,001 — 70,000


70,001 — 99,999


100,000 


Therapeutic
Courses of
Treatment
	 	[***]


[***]


[***]


[***]


[***]


[***]


[***]


[***]


	 	[***]


[***]


[***]


[***]


[***]


[***]


[***]


[***]








	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	TOTAL EST.
	ITEM	 	SUPPLIES/SERVICES	 	QTY/UNIT	 	EST. COST	 	FIXED FEE	 	CPFF
	0006

	 	The Contractor
shall perform
maintenance
production
capacity.


The Contractor
shall manufacture,
release, maintain,
and monitor one (1)
full scale lot of
Bulk Drug Substance
(BDS) per
year for the life
of the life of the
contract in
accordance with
Section C.5,
requirement 8, of
the Statement of
Work.


This is a Cost Plus
Fixed Fee Line Item
	 	1 Job
	 	[***]
	 	[***]
	 	[***]




 
 




			
	[***]	 	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.






6









 






	 	 	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES/SERVICES	 	QTY/ UNIT	 	EST. COST	 	FIXED FEE	 	TOTAL EST. CPFF
	0007

	 	The Contractor
shall conduct
Clinical Trials in
Special
Populations.
	 	1 Job
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	Design and conduct
Clinical Trials in
Special Populations
in accordance with
Section C.5,
Requirement 9, of
the Statement of
Work.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	This is a Cost Plus
Fixed-Fee Line
Item.	 	 	 	 	 	 	 	 






	 	 	 	 	 	 	 	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY/UNIT	 	EST. COST	 	FIXED FEE	 	TOTAL EST. CPFF
	0008

	 	The Contractor
shall conduct Phase
4 Post Marketing
Studies.
	 	1 Job
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	Design and conduct
Phase 4 post
marketing studies
to verify and
describe the
product’s clinical
benefit and assess
safety when used as
indicated (this
CLIN will only be
exercised in the
event the
Government
releases for use
stockpiled product)
in accordance with
Section C.5,
Requirement 4, of
the Statement of
Work.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	This is a Cost Plus
Fixed-Fee 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.





7









 





Section C — Description/Specification/Work Statement



C.1 Project Identification and Purpose



The purpose of this requirement is the acquisition and maintenance within the Strategic National
Stockpile (SNS) of therapeutic products to treat United States (US) civilians with inhalational
anthrax disease. The types of products to be acquired under this solicitation include the
following: immunotherapeutic antitoxins (e.g., monoclonal antibodies, polyclonal antibodies, and
human immune globulin), other protein products (e.g., mutated toxins), and small molecular entity
treatments (e.g., protease inhibitors) for the treatment of inhalational anthrax disease. It is
anticipated that these products would be used concurrently with antimicrobial therapy in the
treatment of symptomatic patients exposed to anthrax. The USG will purchase a quantity of
Investigational New Drug (IND) Final Drug Product (FDP) that includes 10 grams of active
pharmaceutical ingredient and perform independent comparative testing of products from the
Contractor(s). The USG shall conduct an analysis of the comparative testing results. The USG test
information will be one factor among several factors used to determine whether optional ranges of
products in CLIN 0003A will be exercised; the contractor’s own product and test data, as well as
national security considerations, will also be an important component of the USG’s decision
process. The acquisition ranges for this project will be between 10,000 and 100,000 therapeutic
courses of treatment of products from the categories described above. The USG reserves the right to
make one or more awards. Desirable product characteristics include: controlled room temperature
storage; long shelf life; packaging as single or small multiple doses; and no or minimal ancillary
supplies needed to administer the product. Refrigeration would be preferable to freezing if room
temperature storage were not possible. While these are optimal product characteristics, the USG
recognizes that these may not be achievable for all types of products. The USG is interested in
storage proposals that would significantly extend shelf-life.



The Federal Response Plan of the Department of Homeland Security designates the Department of
Health and Human Services (HHS) as the lead agency for public health and medical response to
manmade or natural disasters. In 2002, HHS established the Office of the Assistant Secretary for
Public Health Emergency Preparedness (OASPHEP). This office is responsible for the implementation
of a comprehensive HHS strategy to protect from, and be prepared to respond to, acts of
bioterrorism and other public health emergencies threatening the civilian population.



The Office of Research and Development Coordination (ORDC) in OASPHEP has the primary
responsibility within HHS to contract for large-scale manufacturing and delivery of licensable
products to the SNS in preparation for response to a public health emergency. This requirement
will require the submission of the appropriate FDA regulatory marketing application (New Drug
Application (NDA) or a Biologics License Application (BLA)), application supplements, long-term
maintenance (during the contract period of performance) of the stockpiled products, and long-term
manufacturing base to continue replenishing the stockpile as product expires. Accelerated, stress,
and long-term storage stability testing data supporting a long-term expiration-dating period for
the therapeutic products stored in the SNS is considered important for the USG.



C.2 Background and Need



Recognizing the potential threat posed by the use of infectious agents as weapons of biological
warfare and the deliberate exposure of citizens of the U.S., postal workers, and other USG
employees to Bacillus anthracis spores in 2001, HHS has taken action to stockpile anthrax vaccine.
Antimicrobials are also stored in the SNS for use in the event of another anthrax attack.
Antimicrobials are effective against anthrax bacteria and inhalational anthrax disease may be
prevented if antimicrobial drugs are initiated shortly after exposure to spores. However, any
delay in antimicrobial therapy and/or overwhelming exposure may result in toxemia. The release of
toxins accounts for most of the morbidity and mortality associated with progressive inhalational
anthrax disease. Post-exposure vaccination and antimicrobial interventions are not effective in
treating the toxemia that occurs as the disease progresses. This acquisition is for agents
directed at the treatment of toxemia resulting from inhalational anthrax disease.




8









 







Because of the urgency of this requirement, products to be considered for acquisition must meet the
Absolute Criteria for Eligibility by time of proposal submission. These criteria are:





	 	1)	 	A complete IND submitted to and received by the Food and Drug Administration (FDA) for
initiation of clinical trials. The IND must conform to the requirements as specified in 21
Code of Federal Regulations (CFR) 312.
	 
	 	2)	 	Proof-of concept data in small animals.




Note: Offerors’ products must be allowed to proceed by FDA under IND by time of award.



The urgent nature of the current threat requires an accelerated pace of development, testing, and
procurement of an emergency stockpile of therapeutic products. The USG anticipates that prior to
licensure or approval by the FDA, if an emergency were declared and the appropriate criteria met,
the investigational therapeutic products for inhalational anthrax disease could be administered
under either a Centers for Disease Control and Prevention (CDC)-held Investigational New Drug (IND)
protocol or an Emergency Use Authorization (EUA) submitted by the CDC. Initial therapeutic product
acceptance into the SNS is dependent on the accumulation and submission of the appropriate data to
support the use of the product (under IND) in patients showing symptoms of inhalational anthrax
disease. However, Contractors are required to diligently pursue FDA licensure or approval of all
therapeutic product(s) manufactured and acquired under this Contract, taking all steps required by
FDA.



C.3 Definitions



Accelerated Approval—Approval of a new drug or biological product for a serious or
life-threatening illness based on a surrogate endpoint reasonably likely to predict clinical
benefit or on an effect on a clinical endpoint other than survival or irreversible morbidity. (21
CFR 314 Subpart H; 21 CFR 601 Subpart E.)



Animal Rule—Approval of new drugs or biological products based on evidence of effectiveness from
studies in animals when a) definitive human efficacy studies cannot be conducted because it would
be unethical to deliberately expose healthy human volunteers to a lethal or permanently disabling
toxic biological, chemical, radiological, or nuclear substance; and b) field trials to study the
product’s effectiveness after an accidental or hostile exposure have not been feasible. (21 CFR 314
Subpart I; 21 CFR 601 subpart H.)



Anthrax Therapeutic Product— immunotherapeutic antitoxins (e.g., monoclonal antibodies, polyclonal
antibodies, and human immune globulin), other protein therapeutic products (e.g. mutated toxins),
and small molecular entity treatments (e.g. protease inhibitors) for the treatment of inhalational
anthrax disease.



Advanced development/pivotal studies—Includes 1) expanded human safety studies, 2) animal efficacy
studies if following the Animal Rule or clinical studies required for Accelerated Approval; and 3)
other studies as deemed necessary by FDA for approval or licensure of product.



BDS—Bulk Drug Substance



BLA—Biologics License Application



CBER—Center for Biologics Evaluation and Review



CDC—Centers for Disease Control and Prevention



CDER—Center for Drug Evaluation and Research



CFR—Code of Federal Regulations



cGMP—Current Good Manufacturing Practices: 21 CFR 210, 211 and 600




9









 







EUA—Emergency Use Authorization (Under Public Law 108-276, the Project Bioshield Act of 2004, the
Secretary of HHS may authorize the emergency use of a medical product that is not FDA
approved/licensed for that use. CDC will coordinate EUA activities for products under this
acquisition).



FDA—Food and Drug Administration



FDP—Final Drug Product



GCP—Good Clinical Practices: 21 CFR 50, 54, 56, 312, 314, 361



GLP—Good Laboratory Practices: 21 CFR 58



HHS—Department of Health and Human Services



IACUC—Institutional Animal Care and Use Committee: Public Health Service Policy on Humane Care and
Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/phspol.htm)



ICH—International Conference on Harmonisation



IND—Investigational New Drug



NDA—New Drug Application



OASPHEP—Office of the Assistant Secretary for Public Health Emergency Preparedness



OHRP—Office for Human Research Protections



ORDC—Office of Research and Development Coordination



SDB—Small Disadvantaged Business



SNS— Strategic National Stockpile. The SNS is a national repository of antibiotics, chemical
antidotes, antitoxins, life-support medications; IV administration, airway maintenance and
medical/surgical items. The SNS is designed to supplement and re-supply state and local public
health agencies in the event of a national emergency anywhere and at anytime within the U.S. or its
territories. The SNS includes products in 12-hour push packages (broad spectrum of assets staged
and ready for deployment), SNS-managed inventory and vendor-managed inventory. It is planned that
anthrax therapeutic products will be held in SNS-managed inventory.



Therapeutic course of treatment—the number of doses of a therapeutic product required to treat a
single patient.



US—United States



USG—United States Government




10









 







C.4 Contract Tasks



The Contractor, as an independent organization and not as an agent of the Government, shall furnish
all necessary services, qualified personnel, materials, supplies, equipment, facilities,
transportation and travel as required to:





	 	1)	 	Deliver a quantity of FDP that includes 10 grams of active pharmaceutical ingredient to
treat inhalational anthrax disease for independent comparative testing by the USG.
	 
	 	2)	 	Manufacture between 10,000 and 100,000 therapeutic courses of treatment of a product to
treat inhalational anthrax disease to be delivered to the SNS;
	 
	 	3)	 	Perform accelerated, stress, and long-term storage stability testing to support the
proposed product dating period of the Bulk Drug Substance (BDS) and FDP, and ongoing
stability assessments to support extension of the product dating period (as necessary);
	 
	 	4)	 	Conduct advanced development/pivotal studies, which include a) expanded human safety
studies, b) animal efficacy studies if following the Animal Rule, or clinical studies
required for Accelerated Approval and c) other studies as deemed necessary by FDA.
	 
	 	5)	 	Obtain FDA approval/licensure for the therapeutic entity for the treatment of
inhalational anthrax disease and provide necessary data to CDC to support CDC submission of
a CDC-held IND protocol and/or an EUA to be utilized in the case of an anthrax public
health emergency;
	 
	 	6)	 	Perform quality control and quality assurance monitoring on product in the SNS,
track/rotate inventory of the SNS stored product as needed while the product is under IND,
and perform stability testing of product through the end of the contract;
	 
	 	7)	 	Execute any product disposition directions provided by the USG;
	 
	 	8)	 	Produce, release, maintain and monitor one (1) full scale lot of BDS per year for the
life of the contract in order to maintain cGMP capacity to produce sufficient therapeutic
courses of treatment of the product to replace expired FDP when ordered by the USG;
	 
	 	9)	 	Initiate and complete all human and animal safety and efficacy studies to support
licensure of biologics or approval of drugs for expanded indications for special
populations, including pediatric and geriatric populations. Submit to FDA for review and
potential inclusion in product labeling the results of special population studies;
	 
	 	10)	 	Provide a security plan for development, manufacturing, storage, and distribution of
the product;
	 
	 	11)	 	Provide a security plan for information technology systems.




The Contractor shall perform the work required to manufacture and to gain FDA approval or licensure
of a safe and effective product for treatment of inhalational anthrax disease for delivery to the
SNS in accordance with the requirements outlined below. The primary requirements are listed below
with some containing subcategories of secondary activities. Requirements 1-11 below apply to
all product type for treatment of inhalational anthrax disease.  The Contractor shall
incorporate these requirements into the work plan and timeline.



C.5 Specific Technical Requirements



C.5.A Requirement 1 — Sample of IND FDP





	 	1.	 	The Contractor shall deliver a quantity of FDP that includes 10 grams of active
pharmaceutical ingredient manufactured under cGMP conditions. Comparative testing of the
FDP will be performed by the USG. This FDP shall be comparable to the FDP to be used in
the advanced development/pivotal studies (Requirement 4). The USG does not intend to pay
for any costs associated with Research & Development of the product. Contractor shall
divide the samples for testing into aliquots per direction from the USG. The USG will
receive the sample aliquots from the Contractor, blind the aliquots, and distribute them
for independent testing (such as in vivo or in vitro assays) by the USG. The USG will
coordinate with the FDA regarding the selection of appropriate tests and the quality
standards to be used for those tests. The USG test information will be one factor among
several factors used to determine whether options for additional product will be exercised;
the




11









 






	 	 	 	contractor’s own product and test data, as well as national security considerations,
will also be an important component of the USG’s decision process.






	 	2.	 	The Contractor shall provide all necessary labor, effort, supplies, and other necessary
items in order to provide information and other support services to aid the USG in the
testing of IND FDP.





C.5.B Requirement 2 — Product Manufacturing and cGMP Compliance





	 	1.	 	The Contractor shall conduct cGMP manufacturing of FDP to be delivered to the SNS. The
Contractor shall deliver between 10,000 and 100,000 therapeutic courses of treatment of
FDP. The quantity funded by the exercise of optional CLIN 0003A must be delivered to the
SNS within a timeframe not to exceed thirty-six (36) months after the optional CLIN is
exercised. The BDS and FDP shall meet the specifications agreed upon by the FDA, including
demonstration of consistency of manufacturing, and shall be manufactured under cGMP
conditions that are suitable for FDA approval/licensure.
	 
	 	2.	 	The Contractor shall provide information requested by the FDA in order for FDA to
schedule and to execute a cGMP site-visit to review the manufacturing facility prior to
production of stockpile lots.
	 
	 	3.	 	The Contractor shall provide a proposal to FDA, with copies to the Contracting Officer
and Project Officer, to utilize a single two-part label for both the investigative and
licensed/approved (final approvable label) phases of the product. This labeling strategy
and mockup will address the use of product pre- and post-licensure/approval and should be
designed as not to require re-labeling from an IND label to the FDA approved label once the
BLA/NDA is granted. This proposal should describe how the Contractor will remove the IND
label, the re-labeling of the inner and outer shipping cartons with the approved label,
placement of the approved package insert, and instructions for the end-user for both pre-
and post-licensure/approval scenarios. The proposal should also contain a mockup
(including carton and shipper) and any/all labeling studies consistent with the proposal.
Further instructions will be given after contract award.
	 
	 	4.	 	The Contractor shall provide information on the anticipated storage temperature
(refrigeration would be preferable to freezing if room temperature storage were not
possible), shelf life, and supplies needed to administer the product. The Contractor shall
make every effort to produce a product with high stability and a long shelf life. The
projected type of packaging should be described, (preferably packaging as single or small
multiple doses), including packaging for each unit, number of units per case and number of
cases per pallet. Projected case dimensions should also be described.
	 
	 	5.	 	The Contractor shall provide primary and secondary points of contact that will be
available 24 hours per day, seven days per week to be notified in case of a public health
emergency.
	 
	 	6.	 	The Contractor shall provide data showing comparability between lots of material used
during pre-clinical studies and those intended for clinical studies under IND.
	 
	 	7.	 	If certified by the International Standards Organization, the Contractor shall provide
proof of certification. Certification by the International Standards Organization is not
required for award consideration and the Contractor is not required to obtain such
certification during contract performance.





C.5.C Requirement 3 — Stability and Potency Testing of Finished Therapeutic





	 	1.	 	The Contractor shall validate critical assays necessary for BDS and FDP release,
stability testing, and for potency evaluation. Validation of all assays by the Contractor
will be required for licensure or approval; however FDA will determine which critical assay
parameters require validation for product use under a CDC-held IND protocol and/or EUA to
be utilized in the case of an anthrax public health emergency. Each




12









 






	 	 	 	quantitative analytical procedure shall be designed to minimize assay variation. Formal
quality unit review of analytical test results shall be performed according to established
quality standards and procedures.






	 	2.	 	The Contractor shall conduct adequate stability studies under accelerated, stress, and
long-term storage conditions appropriate for the stage of development and type of product
(e.g., biologic vs. drug) and potency testing. General guidance regarding stability testing
for drug substances, drug products and the biotechnological/biological products can be
found in the ICH guidances “Q1A(R2): Stability Testing of New Drug Substances and Products
(Second Revision)” and “Q5C Quality of biotechnological products: Stability testing of
biotechnological/biological products)” available at
http://www.fda.gov/cder/guidance/index.htm.” The Contractor shall also perform stability
testing at specified time intervals on the BDS lots stored by the Contractor and all FDP
lots placed in the SNS through the end of the contract and provide these results to the
USG. This testing will assess whether the product remains within the product specification
while data to determine an appropriate expiration date are being acquired. The Contractor
shall discuss possible inclusion of the product in the Shelf-Life Extension Program if
deemed appropriate by FDA. At the discretion of the USG and independent of testing
conducted by the Contractor, the USG reserves the right to conduct inspections and collect
samples of product held by the Contractor and in the SNS.





C.5.D Requirement 4 — Design and Conduct Advanced Development/Pivotal Studies





	 	1.	 	The Contractor shall develop and submit plans to conduct advanced development/pivotal
studies including 1) expanded human safety studies, 2) animal efficacy studies (in
appropriate models of inhalational anthrax disease if following the Animal Rule) or
clinical studies required for Accelerated Approval using validated endpoints; and 3) other
studies as deemed necessary by FDA. Contractor shall adhere to Institutional Animal Care
and Use Committee guidelines, Good Laboratory Practice regulations, Good Clinical Practice
regulations, and all other applicable FDA regulations in the conduct of non-clinical and
clinical studies undertaken to support approval/licensure of the product.
	 
	 	2.	 	The Contractor shall initiate and complete advanced development/pivotal studies
including 1) expanded human safety studies, 2) animal efficacy studies (in appropriate
models of inhalational anthrax disease) if following the Animal Rule, or clinical studies
required for Accelerated Approval, and 3) other studies as deemed necessary by FDA. All
studies shall utilize the therapeutic products manufactured by the large-scale or fully
representative process. Clinical studies shall not begin until the responsible FDA Center
(Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and
Review (CBER)) accepts the plans and protocols.
	 
	 	3.	 	Working together with the FDA, the Contractor shall consider the clinical use of the
product (such as concurrently with antibiotics) in the design and conduct of the studies.
	 
	 	4.	 	The Contractor shall present a plan for conducting Phase 4 post-licensure/marketing
studies.1





C.5.E Requirement 5 — Regulatory Submissions for Approval/Licensure and Emergency Use






 




			
	1	 	As noted in the Animal Rule (21 CFR 314
Subpart I; 21 CFR 601 subpart H), the Offeror shall conduct post-marketing
studies, such as field studies, to verify and describe the product’s
clinical benefit and to assess its safety when used as indicated when such
studies are feasible and ethical. Such post-marketing studies may not be
feasible until an exigency arises (i.e., a situation in which anthrax
therapeutics from the SNS are needed to treat U.S. civilians). When such
studies are feasible, the Offeror shall conduct such studies with due
diligence. Similarly, as noted in the regulations for Accelerated Approval (21
CFR 314 Subpart H; 21 CFR 601 Subpart E), approval is “subject to the
requirement that the applicant study the drug further, to verify and describe
its clinical benefit where there is uncertainty as to the relation of the
surrogate endpoint to clinical benefit, or of the observed clinical benefit to
the ultimate clinical outcome.”




13









 











	 	1.	 	The Contractor shall prepare and submit the required regulatory submissions (as it
pertains to the IND, and/or any Drug Master File(s), as specified in but not limited to 21
CFR 312, 314.420, and 601) to the FDA to conduct advanced development/pivotal studies and
obtain approval/licensure.
	 
	 	2.	 	The Contractor shall prepare and submit an original NDA/BLA for therapeutic products
for treatment of inhalational anthrax disease in order to obtain FDA approval/licensure.
The Contractor shall discuss options, e.g. fast track and priority review, with FDA.
	 
	 	3.	 	The Contractor will provide the necessary data to CDC to support CDC submission of a
CDC-held IND protocol and/or EUA to be utilized in the case of an anthrax public health
emergency.
	 
	 	4.	 	Contractor shall provide evidence of general understanding of steps required for FDA
licensure/approval, such as past performance, FDA approval/licensure of other products,
etc.





C.5.F Requirement 6 — Shipment to SNS and Storage





	 	1.	 	The Contractor will assume responsibility for the cost of shipping finished product
once “usable” product requirements have been met to the SNS for long-term storage. The USG
will assume responsibility for the cost of finished product long-term storage and emergency
distribution of the finished product. The USG shall incur only the storage costs while the
product is held within the USG’s control. The product shall remain in storage at the
Contractor’s facility until the delivery of finished product to the SNS.
	 
	 	2.	 	The Contractor shall ensure that the delivery follows cGMP procedures to maintain the
integrity of the product en route. The Contractor shall perform/execute all necessary
pilot transfers and validate the shipping method that will be used for delivery to the SNS
prior to first shipment of product. The Contractor shall file the necessary documentation
to the FDA for the safe movement of the product to include any protocol deviations en
route.
	 
	 	3.	 	The Contractor shall be responsible for the secure and segregated storage of held
intermediates and the FDP prior to lot release and subsequent shipment to the USG. The
Contractor may also be required to store FDP at its own facility for up to three months at
no additional cost. The Contractor may propose a delivery schedule that may not exceed 1
delivery per month. Thirty days advance notice is required prior to shipment to the SNS.
However, while the product is in long-term storage with the USG (i.e., in SNS), the
Contractor shall continue to be responsible for all quality control/quality assurance
monitoring and subsequent reporting necessary to insure appropriate storage conditions of
the product until said product is licensed. The Contractor, via this contract with the
USG, will be expected to establish a written Quality Agreement as to the manner in which
the product will be stored within the specific USG stockpile facility (ies) that will be
identified post contract award. In addition, this Quality Agreement will outline the
responsibilities of both the Contractor and the USG (i.e., SNS- Quality Control). These
documents shall be drafted and signed by both parties prior to the transport and storage of
the product.





C.5.G Requirement 7 — Disposition of Product Inventory



Upon expiration or termination (including partial termination) of this contract, the USG may effect
final disposition of any FDP remaining in storage at the Contractor’s facility or in the SNS by any
one or combination of the following methods:





	 	1.	 	The USG may elect to direct the Contractor to ship within five (5) calendar days prior
to the contract termination date, to a consignee(s) designated by the USG, all FDP
remaining in storage at the Contractor’s facility.
	 
	 	2.	 	The USG may offer the FDP to be repurchased by the Contractor at the original purchase
price.




14









 











The USG may elect to handle disposition of expired FDP by the following method:





	 	3.	 	The USG may elect to direct the Contractor to ship all expired FDP and FDP scheduled to
expire within 30 calendar days to the USG to the location specified by the USG.




C.5.H Requirement 8 — Maintaining Production Capacity



The Contractor shall manufacture, release, maintain and monitor one (1) full scale lot of BDS per
year for the life of the contract in order to maintain cGMP capacity to produce sufficient
therapeutic courses of treatment of the product to replace expired FDP when ordered by the USG.
All BDS shall be tested for stability. The Contractor shall store and handle such BDS lots such
that BDS is suitable for continued manufacture into FDP.



C.5.I Requirement 9 — Clinical Trials in Special Populations



The Contractor shall compile available data and initiate and complete any necessary additional
animal and human studies to obtain expanded labeling in special populations, including pediatric
and geriatric populations. These studies to support additional clinical indications shall be
investigational and conducted under an IND (including, when possible, post-event studies), even if
the product is approved for a different population.



C.5.J Requirement 10 — Security of Contract Operations



The Contractor’s Security Plan shall be included as part of the Technical Proposal and will be
incorporated into any resultant contract. Performance of work under this contract shall be in
accordance with this written Security Plan.



C.5.K Requirement 11 — Information Technology Security



The Contractor’s IT Security Plan shall be included as part of the Technical Proposal and will be
incorporated into any resultant contract. Performance of work under this contract shall be in
accordance with this written IT Security Plan.




15









 







Section D — Packaging and Marking



D.1 Method of Delivery




     Unless otherwise specified by the Contracting Officer or the Contracting Officer’s
representative, delivery of items, to be furnished to the government under this contract (including
invoices), shall be made by first class mail.



16









 





Section E — Inspection and Acceptance




	 	 	 
	FAR SOURCE	 	TITLE AND
DATE

	52.246-2

	 	Inspection of Supplies — Fixed-Price (Aug 1996)
	 
	52.246-3

	 	Inspection of Supplies — Cost-Reimbursement (May 2001)
	 
	52.246-5

	 	Inspection of Services — Cost-Reimbursement (Apr 1984)
	 
	52.246-16

	 	Responsibility for Supplies (Apr 1984)






E.1 Inspection and Acceptance (Jul 1999)




     Inspection and acceptance of the articles, services, and documentation called for herein shall
be accomplished by the Contracting Officer, or his duly authorized representative (who for the
purposes of this contract shall be the Project Officer) at the destination of the articles,
services or documentation.



17









 






Section F — Deliveries Or Performance




	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.211-17

	 	Delivery of Excess Quantities (Sep 1989)
	 
	52.242-15

	 	Stop-Work Order (Aug 1989)
	 
	52.242-15 Alternate I

	 	Stop-Work Order (Alternate I) (Apr 1984)
	 
	52.242-17

	 	Government Delay of Work (Apr 1984)
	 
	52.247-34

	 	F.o.b. — Destination (Nov 1991)
	 
	52.247-35

	 	F.o.b. — Destination, within Consignee’s Premises (Apr 1984)






F.1 Period of Performance





The period of performance shall be twelve (12) months from the effective date of contract
award. The contract contains optional contract line items, which may be exercised by the
government, and could potentially increase the period of performance an additional forty-eight
(48) months.



F.2 Contract Deliverables




     The following deliverables are applicable to CLINs 0001 & 0002: 




	 	1.	 	A quantity of FDP that includes 10 grams of active pharmaceutical ingredient to
be delivered within 2 months of contract award to the USG for comparative testing.
(CLIN 0001)
	 
	 	2.	 	Technical data associated with test support. (CLIN 0002)





     The following deliverables are applicable if optional CLINs 0003 — 0008 are funded:




	 	1.	 	Written Memorandum of Agreement and responsibilities document between the
Contractor and the USG stockpile facility within 6 months of notification of the
USG-chosen storage location. (CLIN 0003A and 0003B)
	 
	 	2.	 	Within the ranges outlined in CLIN 0003A the USG will make a funding
determination of between 10,000 to 100,000 therapeutic courses of treatment for
inhalational anthrax disease. The funded quantity, based upon the exercise of optional
CLIN 0003A, shall be delivered to the SNS as usable product. The quantity funded by
the exercise of optional CLIN 0003A must be delivered to the SNS within a timeframe not
to exceed thirty-six (36) months after the optional CLIN is exercised. All doses
delivered must be licensable/approvable lots if not already licensed/approved, and data
must be provided to support expectation of a reasonable shelf-life in the stockpile.
(CLIN 0003A)
	 
	 	3.	 	A copy of the approval letter from the Contractor’s IRB, a copy of the clinical
protocol, and a copy of the informed consent document to be provided in advance of
beginning any clinical trial. (CLIN 0003B, CLIN 0007, and CLIN 0008)
	 
	 	4.	 	An FDA approval/licensure letter for the NDA/BLA for the therapeutic products
for inhalational anthrax disease to include those therapeutic courses of treatment of
FDP stored in the SNS. (CLIN 0005)




18









 






	 	5.	 	Evidence, including a summary of salient results, of an ongoing Quality
Control/Quality Assurance Program for the monitoring of SNS stored product while the
product is under IND and ongoing stability testing of the retained lots of product in
SNS through the end of the contract. (CLIN 0003B)
	 
	 	6.	 	Submission of final study reports as evidence of completion of any necessary
additional animal and human studies to obtain expanded labeling in special populations,
including pediatric and geriatric populations (CLIN 0007); proof of submission to FDA
of appropriate regulatory submissions to address label changes (CLIN 0004, 0007) and
submission of final study reports for Phase 4 licensure/marketing studies. (CLIN 0008)
	 
	 	7.	 	One (1) full scale lot of BDS per year (to be held at the Contractor’s
facility) to maintain cGMP capacity for the production of the therapeutic products for
inhalational anthrax disease for the life of the contract. (CLIN 0006)
	 
	 	8.	 	Copies of all FDA inspection reports, including Form 483, for all aspects of
final finished product manufacturing and any GMP inspection reports and copies of
correspondence with FDA. (CLIN 0003A and CLIN 0003B)





F.3 Reporting Requirements





The Contractor(s) shall submit to the Contracting Officer and to the Project Officer
technical progress reports covering the work accomplished during each reporting period.
These reports are subject to the technical inspection and requests for clarification by the
Project Officer. These shall be brief and factual and prepared in accordance with the
following format:




Monthly Technical Progress Reports: On the fifteenth of each month for the previous
calendar month, the Contractor shall submit a Monthly Technical Progress Report to the
Project Officer and the Contracting Officer. A monthly report will not be required for the
period when the final report is due. The Contractor shall submit one copy of the Monthly
Progress Report electronically via e-mail. Any attachments to the e-mail report shall be
submitted in Microsoft Word, Excel, Project or compatible versions. Such reports shall
include the following specific information:




The contract number and title, the period of performance being reported, the Contractor’s
name and address, the author(s), and the date of submission;




Section I — An introduction covering the purpose and scope of the contract effort during
the period of performance being reported;




Section II — The report shall detail, document, and summarize the results of work done
during the period covered, including problems encountered and corrective actions taken.
This shall include the information listed below that is applicable, for the relevant CLINs,
for the performance period during the month being reported.




	 	a.	 	Progress in production and delivery of (1) IND FDP for USG
testing and (2) FDP to the SNS
	 
	 	b.	 	Scale up to full production capacity assessment, including raw
material procurement status;
	 
	 	c.	 	Quality control/quality assurance monitoring;
	 
	 	d.	 	FDA inspections and consultation results or recommendations;
	 
	 	e.	 	Storage and stability studies for expiration date results
(accelerated, stress, and long-term storage conditions);




19









 






	 	f.	 	Security assessment;
	 
	 	g.	 	Progress, results, and final reports of expanded human safety
studies;
	 
	 	h.	 	Progress, results, and final reports of efficacy studies
performed in animals if following the Animal Rule, or clinical studies required
for Accelerated Approval;
	 
	 	i.	 	Progress, results, and final reports of any other studies
deemed necessary by FDA;
	 
	 	j.	 	Progress in providing data to CDC to support CDC submission of
a CDC-held IND protocol and/or EUA to be utilized in the case of an anthrax
public health emergency;
	 
	 	k.	 	Progress in obtaining FDA approval/licensure for the
therapeutic entity for the treatment of inhalational anthrax disease;
	 
	 	l.	 	Progress in execution of any product disposition directions
provided by the USG;
	 
	 	m.	 	Progress, results, and final reports of any necessary
additional animal and human studies to obtain expanded labeling in special
populations, including pediatric and geriatric populations;
	 
	 	n.	 	Potency and stability testing results;
	 
	 	o.	 	 Inventory report of total number of FDP therapeutic courses of
treatment in storage during the month, to include: lot number, expiration date,
and bulk quantity (if applicable);
	 
	 	p.	 	Progress in production of one full scale lot of BDS per year in
order to maintain cGMP capacity;
	 
	 	q.	 	Quantity of out-of-date FDP, assessment and recommendations to
replacement FDP orders to maintain required stockpile quantities;
	 
	 	r.	 	Physical storage facilities (Contractor and SNS) assessments






Section III — Overall project assessment, problems encountered, corrective actions taken by
the Contractor, recommendations for USG action, etc. An explanation of any difference
between planned progress and actual progress, why the differences have occurred, and, if
behind planned progress, what corrective steps are planned. The project plan and schedule,
with accompanying Gantt chart, will be updated in each Monthly Report and compared to the
locked project baseline.




Section IV: Summary of the work planned for the next reporting period.




Final Report : By the expiration date of the contract, the Contractor shall submit a
comprehensive Final Report that shall detail, document, and summarize the results of the
entire contract work. The report shall explain comprehensively the results achieved.



20









 





Section G — Contract Administration Data



G.1 Payment by Electronic Funds Transfer (Jan 2000)




     (a) The Government shall use electronic funds transfer to the maximum extent possible when
making payments under this contract. FAR 52.232-34, Payment by Electronic Funds Transfer—Other
than Central Contractor Registration, incorporated by reference in Section I, requires the
contractor to designate in writing a financial institution for receipt of electronic funds transfer
payments.



     (b) The contractor shall make the designation by submitting the form titled “ACH
Vendor/Miscellaneous Payment Enrollment Form” to the address indicated below. Note: The form is
either attached to this contract (see Section J, List of Attachments) or may be obtained by
contacting the Contracting Officer or the CDC Financial Management Office at (404) 687-6666.



     (c) In cases where the contractor has previously provided such designation, i.e., pursuant to
a prior contract/order, and been enrolled in the program, the form is not required.



     (d) The completed form shall be mailed after award, but no later than 14 calendar days before
an invoice is submitted, to the following address:



G.2 Invoice Submission (Jul 1999) (Fixed Price Line Items)




     (a) The Contractor shall submit an original and three copies of contract invoices to the
address shown below:


[***], Contracting Officer

Office of Research and Development Coordination

Department of Health and Human Services

Office of Public Health Emergency Preparedness

200 Independence Avenue, S.W., Room 636G

Washington, D.C. 20201




     (b) The Contractor agrees to include (as a minimum) the following information on each invoice:


(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Contract Number

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Total Amount of Invoice



(10) Name, title and telephone number of person to be notified in the event of a defective
invoice



(11) Payment Address, if different from the information in (c)(1).





Invoice Submission — (Cost Type Line Items)




(c) Contractor voucher requests for reimbursement shall conform to the form, format, and
content requirements of the Billing Instructions for Negotiated Cost Type Contracts, made a
part of the contract in Section J.





 




			
	[***]	 	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.





21









 






(d) The Contractor shall, in addition to the above requirements, submit a detailed breakout of
costs as supporting backup and shall place the following signed Contractor Certification on
each invoice/voucher submitted under this contract:




I certify that this voucher reflects (fill in Contractor’s name) request for
reimbursement of allowable and allocable costs incurred in specific performance of work
authorized under Contract (fill in contract number)/Task (fill-in task order
number, if applicable), and that these costs are true and accurate to the best of my
knowledge and belief.




(Original Signature of Authorized Official)

Typed Name and Title of Signatory




(e) The date of receipt of a proper invoice/voucher by the Contracting Officer shall be used
for the purpose of Prompt Payment Act time computations.



G.4 Reimbursement of Cost (Apr 2000)




     (a) For the performance of this contract, the Government shall reimburse the Contractor the
cost determined by the Contracting Officer to be allowable (hereinafter referred to as allowable
cost) in accordance with the clause entitled Allowable Cost and Payment in Section I, Contract
Clauses. Examples of allowable costs include, but are not limited to, the following:



     (1) All direct materials and supplies which are used in the performing of the work provided
for under the contract, including those purchased for subcontracts and purchase orders.



     (2) All direct labor, including supervisory, that is properly chargeable directly to the
contract, plus fringe benefits.



     (3) All other items of cost budgeted for and accepted in the negotiation of this basic
contract or modifications thereto.



     (4) Special expenditures which, upon request from the Contractor, the Contracting Officer
approves as being an allowable cost under this contract, such as purchase or lease of office
furniture or equipment, etc..



     (5) All travel costs plus per diem or actual subsistence for personnel while in an actual
travel status in direct performance of the work and services required under this contract. These
costs will be in accordance with the Contractor’s policy and subject to the following:



          (i) Air travel shall be by the most direct route using “air coach” or “air tourist” (less than
first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons
other than avoidable delay in making reservations, would require circuitous routing or entail
additional expense offsetting the savings on fare, or would not make necessary connections).




          (ii) Rail travel shall be by the most direct route, first class with lower berth or nearest
equivalent.




          (iii) Costs incurred for lodging, meals, and incidental expenses shall be considered
reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates
set forth in the Federal Travel Regulation (FTR).




          (iv) Travel via privately owned automobile shall be reimbursed at not more than the current
General Services Administration (GSA) FTR established mileage rate.




     (b) Except as stated herein, the Contractor shall not incur costs unless the prior written
authorization of the Contracting Officer has been obtained. When costs are incurred without such
prior authorization, with the intent of claiming reimbursement as direct costs, it shall be at the
contractor’s risk.



22









 





G.5 Payments (Jul 1999) (Cost Type Line Items only) (See B.7 for dollar amounts)




     The cost of the work to be performed by the Contractor under this contract (exclusive of
the fixed-fee) is estimated at $             . The Contractor shall receive a fixed-fee of $             for a total
estimated cost-plus-fixed-fee of $             . The Contractor shall invoice for his fixed-fee in accordance
with the clause of Section I entitled “Fixed-Fee” — FAR 52.216-08. Subject to the provisions of
the clause entitled “Allowable Cost and Payment” of Section I, payments shall be made on a monthly
basis as work progresses. After payment of 85% of the fixed-fee, as provided for in the clause
entitled “Fixed-Fee” — FAR 52.216-08 of Section I, further payment on account of the fixed-fee
shall be withheld until final payment.



G.6 Contracting Officer (Jul 1999)




     (a) The Contracting Officer is the only individual who can legally commit the Government to
the expenditure of public funds. No person other than the Contracting Officer can make any changes
to the terms, conditions, general provisions, or other stipulations of this contract.



     (b) No information, other than that which may be contained in an authorized modification to
this contract, duly issued by the Contracting Officer, which may be received from any person
employed by the United States Government, or otherwise, shall be considered grounds for deviation
from any stipulation of this contract.



G.7 Evaluation of Contractor Performance (Jan 2000)




     (a) Purpose:



     In accordance with FAR 42.1502, the Contractor’s performance will be periodically evaluated by
the government in order to provide current information for source selection purposes. These
evaluations will therefore be marked “Source Selection Information.”



     (b) Performance Evaluation Period:



     The Contractor’s performance will be evaluated at least annually.



     (c) Evaluators:



     The performance evaluation will be completed jointly by the Project Officer and the
Contracting Officer.



     (d) Performance Evaluation Factors:



     The contractor’s performance will be evaluated in accordance with the attachment listed in
Section J titled “Performance Evaluation Report.”



     (e) Contractor Review:



     A copy of the evaluation will be provided to the contractor as soon as practicable after
completion of the evaluation. The contractor shall submit comments, rebutting statements, or
additional information to the Contracting Officer within 30 calendar days after receipt of the
evaluation.



     (f) Resolving Disagreements Between the Government and the Contractor:



     Disagreements between the parties regarding the evaluation will be reviewed at a level above
the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the
contracting agency. Copies of the evaluation, contractor response, and review comments, if any,
will be retained as part of the evaluation.



23









 





     (g) Release of Contractor Performance Evaluation Information:



     The completed evaluation will not be released to other than Government personnel and the
contractor whose performance is being evaluated. Disclosure of such information could cause harm
both to the commercial interest of the Government and to the competitive position of the contractor
being evaluated as well as impede the efficiency of Government operations.



     (h) Source Selection Information:



     Departments and agencies may share past performance information with other Government
departments and agencies when requested to support future award decisions. The information may be
provided through interview and/or by sending the evaluation and comment document to the requesting
source selection official.



     (i) Retention Period:



     The agency will retain past performance information for a maximum period of three years after
completion of contract performance for the purpose of providing source selection information for
future contract awards.



G.8 Negotiated Indirect Cost Rates





	 	(a)	 	Notwithstanding the provisions of the clause entitled “Allowable Cost and Payment” in
Section I, Contract Clauses, allowable indirect costs under this contract shall be
obtained by applying negotiated indirect cost rates to bases agreed upon by the parties,
as specified below.
	 
	 	(b)	 	Pending establishment of final rates for any period, the Contractor shall be
reimbursed for allowable indirect costs at the following rate(s):





	 	 	 	 	 
	TYPE	 	RATE	 	BASE
	Fringe Benefits

	 	[***]
	 	Direct Labor
	G & A

	 	[***]
	 	Direct Labor







 




			
	[***]	 	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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Section H — Special Contract Requirements



H.1 HHSAR 352.270-5 Key Personnel (Apr 1984)



The personnel specified in this contract are considered to be essential to the work being performed
hereunder. Prior to diverting any of the specified individuals to other programs, the Contractor
shall notify the Contracting 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 shall be made by the Contractor without the written consent of the
Contracting Officer; provided, that the Contracting Officer may ratify in writing such diversion
and such ratification shall constitute the consent of the Contracting Officer required by this
clause. The contract may be modified from time to time during the course of the contract to either
add or delete personnel, as appropriate.




	 	 	 	 	 
	[***]

[***]

[***]

[***]

[***]
	 	[***]

[***]

[***]

[***]

[***]
	 	 






H.2 Prohibition on the Use of Appropriated Funds for Lobbying Activities (Jul 1999)




     The contractor 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 of 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.3 Smoke Free Environment (Jul 1999)




     In compliance with Department of Health and Human Services (DHHS) regulations, all contractor
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 which are open to the public. This policy is also applicable to
contractor personnel who do not work full-time within CDC/ATSDR facilities, but are attending
meetings within CDC/ATSDR facilities.





 




			
	[***]	 	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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H.4 Representations, Certifications and Other Statements of Offerors (Jul 1999)




     The Representations, Certifications and Other Statements of Offerors submitted by [***] dated
10/25/04 are hereby incorporated by reference, with the same force and effect as if they were given
in full text.



H.5 Government Property (Jan 2000)




     (a) Government-Furnished Property (GFP). The Government reserves the right to supply the
Contractor, as Government-furnished property, any additional supplies, equipment, and materials
determined by the Contracting Officer to be necessary and in the best interest of the Government in
the performance of this contract provided the property is furnished, or the Contractor is notified
of the Government’s intent to furnish it, prior to the Contractor’s commitment to acquire such
items.



     (b) Contractor-Acquired Property (CAP). Regardless of the place of performance, when the
costs of such items will be charged to the contract, the Contractor must receive written consent
from the Contracting Officer prior to purchase of any item which requires such consent under FAR
52.244-2 (see Section I, FAR 52.244-2, paragraphs (c), (d) and (e)).



     (c) If performance of this contract is within and on Government facilities, and the
Government-furnished property or contractor-acquired property is for use only within or on the
Government facilities, the control and accountable record keeping for such property shall be
retained by the Government (see FAR 52.245-1, Property Records). The Contractor shall remain
accountable for loss or damage, but will not be required to submit an annual inventory or place its
own bar codes on the items. The Government will provide property labels and other identification
for contractor-acquired Government property under this paragraph.



     (d) If performance of this contract is not within Government facilities, and there is either
Government-furnished property or contractor-acquired property being used in performance of the
work, the Contractor shall be responsible for the control and accountable record keeping for such
property 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.



     (e) The Chief of Material Management Branch, PGO, Centers for Disease Control and Prevention
(CDC), is hereby designated as the Property Administrator for this contract. The Contractor agrees
to furnish information regarding the Government property under this contract to the Property
Administrator, an authorized representative, or a duly designated successor(s). The Contractor
shall identify each item of equipment furnished by the Government to the Contractor or acquired by
the Contractor using contract funds, with a suitable decal, tag, or other marking, as prescribed by
the Property Administrator, and shall follow the guidance set forth in the “Contractor’s Guide for
Control of Government Property.”



H.6 Year 2000 Compliance (Jul 1999)




     Unless elsewhere exempted, information technology (if any) to be acquired under this
contract/purchase order, which will be required to perform date/time processing involving dates
subsequent to December 31, 1999, shall be Year 2000 compliant as defined in Federal Acquisition
Regulation Part 39.002.


H.7 Registration with the Select Agent Program for Work Involving the Possession, Use, and/or
Transfer of Select Biological Agents or Toxins




Work involving select biological agents or toxins shall not be conducted under this contract until
the contractor and any affected subcontractor(s) are granted a certificate of registration or are
authorized to work with the applicable select agents.


For prime or subcontract awards to domestic institutions who possess, use, and/or transfer Select
Agents under this contract, the institution must complete registration with the Centers for Disease
Control and Prevention (CDC),





 




			
	[***]	 	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.




26









 







Department of Health and Human Services (DHHS) or the Animal and Plant Health Inspection Services
(APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work involving
Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work involving
Select Agents, as defined in 42 CFR 73, if the final registration certificate is denied.



For prime or subcontract awards to foreign institutions who possess, use, and/or transfer Select
Agents under this contract, the institution must provide information satisfactory to the Government
that a process equivalent to that described in 42 CFR 73
(http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S. institutions is in place and will be
administered on behalf of all Select Agent work sponsored by these funds before using these funds
for any work directly involving the Select Agents. The contractor must provide information
addressing the following key elements appropriate for the foreign institution: safety, security,
training, procedures for ensuring that only approved/appropriate individuals have access to the
Select Agents, and any applicable laws, regulations and policies
equivalent to 42 CFR 73. The
Government will assess the policies and procedures for comparability to the U.S. requirements
described in 42 CFR Part 73. When requested by the contracting officer, the contractor shall
provide key information delineating any laws, regulations, policies, and procedures applicable to
the foreign institution for the safe and secure possession, use, and transfer of Select Agents.
This includes summaries of safety, security, and training plans, and applicable laws, regulations,
and policies. For the purpose of security risk assessments, the contractor must provide the names
of all individuals at the foreign institution who will have access to the Select Agents and
procedures for ensuring that only approved and appropriate individuals have access to Select Agents
under the contract.



Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins
as well as information about the registration process, can be obtained on the Select Agent Program
Web site at http://www.cdc.gov/od/sap/.




H.8 Protection of Human Subjects



1. Basic Requirements:





	 	a)	 	No contract involving human subjects research shall be awarded until acceptable
assurance has been given that the project or activity will be subject to initial and
continuing review by an appropriate institutional review committee(s) as described in 45
CFR Part 46. Contracts involving human subjects will not be awarded to an individual
unless the individual is affiliated with or sponsored by an institution that has an Office
for Human Research Protections (OHRP) approved assurance of compliance in place and will
assume responsibility for safeguarding the human subjects involved. The OHRP web site is:
http://www.hhs.gov/ohrp. The Offeror further agrees to provide certification at least
annually that the institutional review board has reviewed and approved the procedures which
involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.
	 
	 	b)	 	The Offeror shall bear full responsibility for the performance of all work and services
involving the use of human subjects under this contract in a proper manner and as safely as
is feasible. The parties hereto agree that the Offeror retains the right to control and
direct the performance of all work under this contract. Nothing in this contract shall be
deemed to constitute the Offeror or any subcontractor, agent or employee of the Offeror, or
any other person, organization, institution, or group of any kind whatsoever, as the agent
or employee of the Government. The Offeror agrees that it has entered into this contract
and will discharge its obligations, duties, and undertakings and the work pursuant thereto,
whether requiring professional judgment or otherwise, as an independent Offeror without
imputing liability on the part of the Government for the acts of the Offeror or it
employees.
	 
	 	c)	 	If at any time during performance of this contract, the Contracting Officer determines,
in consultation with the OHRP, that the Offeror is not in compliance with any of the
requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting
Officer may immediately suspend, in whole or in part, work and further payments under this
contract until the Offeror corrects such noncompliance. Notice of the suspension may be
communicated by telephone and confirmed in writing.




27









 






	 	d)	 	If the Offeror fails to complete corrective action within the period of time designated in
the Contracting Officer’s written notice of suspension, the Contracting Officer may, in
consultation with OHRP, terminate this contract in whole or in part, and the Offeror’s name
may be removed from the list of those Offerors with approved Health and Human Services Human
Subject Assurances.




2. Restricted Award:



This contract requires the awardees to participate in the development and implementation of new
study protocols involving human subjects. Under governing regulations, Federal funds which are
administered by the Centers for Disease Control and Prevention (CDC) shall not be expended by the
awardees for research involving human subjects, nor shall human subjects be involved in research
activities by the awardees under this award unless satisfactory evidence of approval by the
awardee’s Institutional Review Board for the Protection of Human Subjects (IRB) is submitted to CDC
by the awardees within 40 days of development of the protocol. Each performance site must also
assure compliance with 45 CFR 46 and receive the IRB’s approval before expenditure of funds or
involvement of human subjects.



H.9 Animal Care



Notice to Offerors of Requirement for Adequate Assurance of Protection of Vertebrate Animal
Subjects



The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations
proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office for
Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the
humane care and use of live vertebrate animals involved in research activities supported by the
PHS. The PHS Policy stipulates that an applicant organization, whether domestic or foreign, bears
responsibility for the humane care and use of animals in PHS-supported research activities. Also,
the PHS policy defines “animal” as “any live, vertebrate animal used, or intended for use, in
research, research training, experimentation, biological testing or for related purposes.” This
Policy implements and supplements the U.S. Government Principles for the Utilization and Care of
Vertebrate Animals Used in Testing, Research, and Training, and requires that institutions use the
Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an
institutional animal care and use program. This Policy does not affect applicable State or local
laws or regulations that impose more stringent standards for the care and use of laboratory
animals. All institutions are required to comply, as applicable, with the Animal Welfare Act as
amended (7 USC 2131 et. seq.) and other Federal statutes and regulations relating to animals. These
documents are available from the Office of Laboratory Animal Welfare, National Institutes of
Health, Bethesda, MD 20892, (301) 496-7163. See http://grants.nih.gov/grants/olaw/olaw.htm.



No PHS supported work for research involving vertebrate animals will be conducted by an
organization, unless that organization is operating in accordance with an approved Animal Welfare
Assurance and provides verification that the Institutional Animal Care and Use Committee (IACUC)
has reviewed and approved the proposed activity in accordance with the PHS policy. Applications may
be referred by the PHS back to the institution for further review in the case of apparent or
potential violations of the PHS Policy. No award to an individual will be made unless that
individual is affiliated with an assured organization that accepts responsibility for compliance
with the PHS Policy. Foreign applicant organizations applying for PHS awards for activities
involving vertebrate animals are required to comply with PHS Policy or provide evidence that
acceptable standards for the humane care and use of animals will be met. Foreign applicant
organizations are not required to submit IACUC approval.



Care of Live Vertebrate Animals



1. Before undertaking performance of any contract involving research on live, vertebrate animals,
the Offeror shall register with the Secretary of Agriculture of the United States in accordance
with 7 U.S.C. 2316 and 9 CFR Section 2.30. The Offeror shall furnish evidence of such registration
to the Contracting Officer.



2. The Offeror shall acquire animals used in research from a dealer licensed by the Secretary of
Agriculture under 7 U.S.C. 2131-2157 and 9 CFR Sections 2.1-2.11, or from a source that is exempt
from licensing under those sections.




28









 







3. The Offeror agrees that the care and use of any live, vertebrate animals used or intended for
use in the performance of this contract will conform with the PHS Policy on Humane Care and Use of
Laboratory Animals, the current Animal Welfare Assurance, the Guide for the Care and Use of
Laboratory Animals prepared by the Institute of Laboratory Animal Resources, and the pertinent laws
and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR
Subchapter A, Parts 1-3). In case of conflict between standards, the more stringent standard shall
be used.



4. If at any time during performance of this contract, the Contracting Officer determines, in
consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health
(NIH), that the Offeror is not in compliance with any of the requirements and/or standards stated
in paragraphs (1) through (3) above, the Contracting Officer may immediately suspend, in whole or
in part, work and further payments under this contract until the Offeror corrects the
noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing.
If the Offeror fails to complete corrective action within the period of time designated in the
Contracting Officer’s written notice of suspension, the Contracting Officer may, in consultation
with OLAW, NIH, terminate this contract in whole or in part, and the Offeror ‘s name may be removed
from the list of those Offeror s with approved Public Health Service Animal Welfare Assurances.



The Offeror may request registration of its facility and a current listing of licensed dealers from
the Animal Care Sector Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for
the sector in which its research facility is located. The location of the appropriate APHIS
Regional Office, as well as information concerning this program, may be obtained by contacting:
Animal Care Staff USDA/APHIS 4700 River Road, Unit 84 Riverdale, MD 20737 (301) 734-4980. Offerors
proposing research that involves live, vertebrate animals will be contacted by OLAW and given
detailed instructions on filing a written Animal Welfare Assurance with the PHS. Offerors are
encouraged to visit the OLAW website at http://grants.nih.gov/grants/olaw/olaw.htm for
additional information. OLAW may be contacted at the National Institutes of Health at (301)
594-2289.



Approval of Required Assurance by OLAW



Under governing regulations, federal funds which are administered by the Centers for Disease
Control and Prevention (CDC) shall not be expended by the Offeror for research involving live
vertebrate animals, nor shall live vertebrate animals be involved in research activities by the
Offeror under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR
Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office
of Laboratory Animal Welfare (OLAW). Each performance site (if any) must also assure compliance
with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities
which do not directly involve live vertebrate animals (i.e. are clearly severable and independent
from those activities that do involve live vertebrate animals) may be conducted by the Offeror or
individual performance sites pending OLAW approval of their respective assurance of compliance with
7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28. Additional information regarding OLAW may be obtained
via the Internet at
http://grants2.nih.gov/grants/olaw/olawaddr.htm.



H.10 Indemnification and Support Anti-Terrorism by Fostering Effective Technologies Act of 2002
(Safety Act)



Indemnification: The Contractor shall be required to attempt to obtain clinical trial
insurance. If Contractors are unable to obtain sufficient insurance coverage for activities under
the contract, and the Contractor desires indemnification pursuant to Public Law No. 85-804 from the
USG, the Contractor shall submit a request to DHHS for indemnification by the USG. The
Contractor’s “Request for Indemnification” shall provide all information and documentation as
required by Federal Acquisition Regulation 50.403-1(a) (“Indemnification Requests”). Such requests
may be forwarded to the Contracting Officer at any time; however in accordance with the FAR,
requests for indemnification will not be considered for approval until after contract award.



The United States Government agrees that the Anthrax Therapeutics Product delivered under this
contract will not be used in humans unless indemnification has been approved in accordance with FAR
subpart 50.4 that is mutually agreeable to both parties or another sufficient liability protection
mechanism is enacted or established. The United States Government will assist the Contractor in
resolving the Contractor’s liability concerns related to this contract





29









 







and will not take any public position adversely affecting the Contractor’s requirement for full
indemnification or liability protection before the product may be used in humans consistent with
this contract.



SAFETY Act: As a requirement of indemnification, Contractor will be required by the terms
of the indemnification agreement to request to the Department of Homeland Security (DHS) for
liability protection under the terms of the SAFETY Act. (6 U.S.C. §§ 441-44; see
also 6 C.F.R. pt. 25)



H.11 Laboratory License Requirement



The Offeror shall comply with all applicable FDA requirements, requirements of Section 353 of the
Public Health Service Act (Clinical Laboratory Improvement Act as amended) and the Current Good
Manufacturing Practices Regulations (cGMP). This requirement shall also be included in any
subcontract for services under this contract.



H.12 Manufacturing Standards



The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the
standard to be applied for manufacturing, processing and packing of this therapeutic product.



If at any time during the life of the contract, the Offeror fails to comply with cGMP in the
manufacturing, processing and packaging of this therapeutic product and such failure results in a
material adverse effect on the safety, purity or potency of this therapeutic product (a material
failure) as identified by CBER and CDER, the Offeror shall have thirty (30) calendar days from the
time such material failure is identified to cure such material failure. If the Offeror fails to
take such an action within the thirty (30) calendar day period, then the contract may be
terminated.



H.13 Review and Approval



The Contractor shall not release any reports, manuscripts, press releases, or abstracts about the
work being performed under this contract, without written approval in advance from the Government.



H.14 Incorporation of Technical Proposal



The Contractor’s technical proposal dated 10/26/04, 6/8/05, 7/21/05, & 9/6/05, submitted in
response to RFP 2004-N-01385, is hereby incorporated into the contract by reference. The Contractor
shall perform the work substantially as set forth in the technical proposal. Any revisions to the
technical proposal that would significantly alter the technical approach must be approved in
writing by the Contracting Officer. In the event of a conflict between Section C, Statement of
Work, and the Contractor’s technical proposal, Section C shall take precedence.



H.15 Identification and Disposition of Data



The Contractor will be required to provide certain data generated under this contract to the
Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data
determined by DHHS to be relevant to this contract. The contractor shall keep copies of all data
required by the Food and Drug Administration (FDA) relevant to this contract for the time specified
by the FDA.



H.16 Intellectual Property



The USG expects and requires that any successful offeror will take all steps necessary to secure
access to all intellectual property, know-how and tangible materials prior to contract award and
that the offeror will need to fulfill its obligations under the contract. Accordingly, the USG
requires evidence that the offeror has secured access to such intellectual property, know-how and
tangible materials necessary to fulfill its obligations under the contract.




30









 







H.17 Privacy Act Applicability





	 	(a)	 	Notification is hereby given that the Contractor and its employees are subject to criminal
penalties for violation of the Privacy Act to the same extent as employees of the Government.
The Contractor shall assure that each of its employees knows the prescribed rules of conduct
and that each is aware that he or she can be subjected to criminal penalty for violation of
the act.
	 
	 	(b)	 	The Project Officer is hereby designated as the official who is responsible for monitoring
contractor compliance with the Privacy Act.
	 
	 	(c)	 	This solicitation requires the Contractor to do one or more of the following: design,
develop, or operate a system of records to accomplish an agency function in accordance with
the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable
agency regulations. Violations of the Act may involve the imposition of criminal penalties.
The Privacy Act System of Records applicable to this project is yet to be assigned.




H.18 Prohibition on Contractor Involvement with Terrorist Activities



The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to
Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provision of
resources and support to, individuals and organizations associated with terrorism. It is the legal
responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This
clause must be included in all subcontracts issued under this contract.



H.19 Priority of Government Requirements



The contractor is not restricted in marketing this product outside the United States and its
possessions provided that such marketing does not interfere with performance under this contract.
The Contractor is permitted to market the product developed under this contract in the United
States and its possessions provided that such marketing does not interfere with performance under
this contract.



H.20 Security Plan Requirements



The Contractor is required to have an established security plan for the development, manufacturing,
storage and distribution work performed under this contract that ensures against theft, tampering
or destruction of pertinent documents and the specific therapeutic for inhalational anthrax
disease. The Contractor’s security plan shall demonstrate how the physical facilities will be
protected using, for example, fencing, controlled access, surveillance equipment, tamper evident
packaging, and armed guards.



The Security Plan shall also describe the procedures to be utilized to control the general internal
operations of the firm and a description of the facility(ies) in which the work will be performed,
including any subcontractors. The Security Plan shall also describe the Contractor’s process for
conducting background investigations for all employees and subcontractors who will have access to
the development, manufacturing and storage of the product.



This plan shall include the security measures to be used to protect the therapeutic to be stored at
the Contractor’s facility (e.g., refrigeration/freezer alarm systems, backup electrical power
generator systems, etc.), and the contingency plan (including any backup or redundant facilities)
to accommodate any manufacturing and storage problems caused by natural or man-made disasters,
power loss, refrigerant loss, equipment failures, etc. The contingency plan shall include a
description of the timeline for restarting production.




31









 







H.21 Information Technology Security



The Contractor shall provide information in both paper and electronic formats to Government
Agencies and support services Contractors, including and especially the SNS, per USG direction. The
Contractor shall provide the IT security plan to safeguard computers, databases, and other IT
materials associated with the contract. This plan shall demonstrate confidentiality and integrity
of and timely access by authorized individuals to data, information and information technology
systems. The Contractor shall agree to comply with the IT system security and/or privacy
specifications set forth in the Statement of Work, the Computer Security Act of 1987 Office of
Management and Budget (OMB) Circular A-130, Appendix III, “Security of Federal Automated
Information Systems,” and the DHHS Automated Information Systems Security Program Handbook (Release
2.0, dated May 1994). The Contractor further agrees to include this provision in any subcontract
awarded pursuant to this prime contract. NOTE: OMB A-130
<http://wwwoirm.nih.gov/policy/aissp.html> is accessible via web site.



H.22 Reserved



H.23 Changes resulting from Amendment 00003 to the RFP 2004-N-01385





	A.	 	Compliance with Project BioShield: Section I.1, FAR 52.216-7, Allowable Cost and Payment (Dec
2002)(DEVIATION). Paragraph (a)(1) is modified to read: In accordance with Public Law
108-276, the Contractor may not invoice for payment under contract line item number 0003B,
0006, 0007, and 0008 prior to satisfying the paragraph of this contract entitled “Payment
conditioned on delivery of usable product.” After satisfaction of the paragraph “Payment
conditioned on delivery of usable product,” the Government will make payments to the
Contractor when requested as work progresses, but (except for small business concerns) not
more often than once every 2 weeks, in amounts determined to be allowable by the Contracting
Officer in accordance with Federal Acquisition Regulation (FAR) Subpart 31.2 in effect on the
date of this contract and the terms of this contract. The Contractor may submit to an
authorized representative of the Contracting Officer, in such form and reasonable detail as
the representative may require, an invoice or voucher supported by a statement of the claimed
allowable cost for performing this contract.






	B.	 	Payment conditioned on delivery of usable product: No payment shall be made under Optional
CLINS until the delivery and acceptance of one production run of FDP under CLIN 0003A of
“usable” product supported by a sufficient body of safety, efficacy, and cGMP manufacturing
data to use under a CDC-held IND protocol and/or EUA, or licensed/ approved product.






	C.	 	Definition of Usable Product: Usable product is defined as the final formulation of drug
product derived from a fully validated manufacturing process, i.e., consistency lot FDP.
There must be a high degree of confidence, as determined by the FDA, that all manufactured
units of FDP from successive lots will meet acceptable product specifications as demonstrated
by comprehensive and satisfactory in-process and release testing. A minimum of three (3)
consistency lots must be manufactured at commercial scale to demonstrate reproducibility and
provide an accurate measure of variability among successive runs. The product must meet
stability specifications to the satisfaction of FDA prior to entry into the SNS. The efficacy
data to support usable product and license requirements must be derived from studies using FDP
produced from a fully validated manufacturing process. An ongoing stability program must be
in place using a stability indicating assay(s) that has been agreed upon by FDA.





H.24 Government Assistance to Contractor in Litigation.



In the event that a claim or suit for damages is brought against the Contractor by a third party
arising out of its performance of this contract, the Government will provide reasonable and timely
access to documents potentially relevant to the Contractor’s assertion of defenses to any dispute
with a third party, including but not limited to a claim for bodily injury or other damages
allegedly arising out of the use or ingestion on any product delivered to the





32









 







Government under this contract. In addition, the Government will consider any request from the
contractor, to assist the Contractor in litigation, including a request to support the contractor’s
assertion of appropriate defenses, including but not limited to the government contractor defense.
If and when appropriate, the Government will file papers in support of the Contractor’s assertion
of its defenses it such disputes.




H.25 Intellectual Property.



This contract is entered into on the understanding that the Unites States Government will not take
any affirmative action to impair Contractor’s exclusive ownership of intellectual property brought
to this contract, including, but not limited to, its patents or data rights, know-how, processes,
procedures and methods (unless these are subject Inventions), its Master File and the existing IND.





33









 








Section I — Contract Clauses




Section I-1 — Clauses Incorporated By Reference




I.1 52.252-2 Clauses Incorporated by Reference (Feb 1998)




     This contract incorporates one or more clauses by reference, with the same force and effect as
if they were given in full text. Upon request, the Contracting Officer will make their full text
available. Please note that clauses are applicable to the various cost-reimbursement and
fixed-price CLINs as provided by the FAR. Also, the full text of a clause may be accessed
electronically at the address(es) below:



http://www.arnet.gov/far

http://farsite.hill.af.mil/VFFARa.htm or VFFAR1.htm




	 	 	 
	FAR SOURCE	 	TITLE
AND DATE
	52.202-1

	 	Definitions (July 2004)
	 
	52.203-3

	 	Gratuities (Apr 1984)
	 
	52.203-5

	 	Covenant Against Contingent Fees (Apr 1984)
	 
	52.203-6

	 	Restrictions on Subcontractor Sales to the Government (Jul 1995)
	 
	52.203-7

	 	Anti-Kickback Procedures (Jul 1995)
	 
	52.203-8

	 	Cancellations, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Jan 1997)
	 
	52.203-10

	 	Price or Fee Adjustment for Illegal or Improper Activity (Jan 1997)
	 
	52.203-12

	 	Limitation on Payments to Influence Certain Federal Transactions (Jun 2003)
	 
	52.204-4

	 	Printed or Copied Double-Sided on Recycled Paper (Aug 2000)
	 
	52.209-6

	 	Protecting the Governments Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Jan 2005)
	 
	52.215-2

	 	Audit and Records — Negotiation (Jun 1999)
	 
	52.215-8

	 	Order of Precedence — Uniform Contract Format (Oct 1997)
	 
	52.215-10

	 	Price Reduction for Defective Cost or Pricing Data (Oct 1997)
	 
	52.215-12

	 	Subcontractor Cost or Pricing Data (Oct 1997)
	 
	52.215-14

	 	Integrity of Unit Prices (Oct 1997)
	 
	52.215-15

	 	Pension Adjustments and Asset Reversions (Oct 2004)
	 
	52.215-18

	 	Reversion or Adjustment of Plans for Postretirement Benefits (PRB) Other Than
Pensions (July 2005)
	 
	52.215-19

	 	Notification of Ownership Changes (Oct 1997)
	 
	52.215-20

	 	Requirements for Cost or Pricing
Data or Information Other Than Cost or Pricing Data (Oct 1997)
	 
	52.215-21

	 	Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing
Data — Modifications (Oct 1997)
	 
	52.216-7

	 	Allowable Cost and Payment (Dec 2002)(DEVIATION) See H.23A






34









 






	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.216-8

	 	Fixed Fee (Mar 1997)
	 
	52.217-5

	 	Evaluation of Options (Jun 1988)
	 
	52.217-6

	 	Option for Increased Quantity (Mar 1989)(Insert: “one year after contract award”)
	 
	52.217-7

	 	Option for Increased Quantity
— Separately Priced Line Item (Mar 1989) (Insert: “one year after contract award”)
	 
	52.219-8

	 	Utilization of Small Business Concerns (May 2004)
	 
	52.219-9

	 	Small Business Subcontracting Plan (Jan 2002)
	 
	52.219-9

	 	Small Business Subcontracting Plan (Alternate II) (Oct 2001)
	 
	52.219-16

	 	Liquidated Damages — Subcontracting Plan (Jan 1999)
	 
	52.219-25

	 	Small Disadvantaged Business Participation Program — Disadvantaged Status and
Reporting (Oct 1999)
	 
	52.222-2

	 	Payment for Overtime Premiums (Jul 1990)
	 
	52.222-3

	 	Convict Labor (Jun 2003)
	 
	52.222-20

	 	Walsh-Healey Public Contracts Act (Dec 1996)
	 
	52.222-21

	 	Prohibition of Segregated Facilities (Feb 1999)
	 
	52.222-22

	 	Previous Contracts and Compliance Reports (Feb 1999)
	 
	52.222-26

	 	Equal Opportunity (Apr 2002)
	 
	52.222-35

	 	Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and
Other Eligible Veterans (Dec 2001)
	 
	52.222-36

	 	Affirmative Action for Workers with Disabilities (Jun 1998)
	 
	52.222-37

	 	Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and
Other Eligible Veterans (Dec 2001)
	 
	52.223-3

	 	Hazardous Material Identification and Material Safety Data (Jan 1997)
	 
	52.223-6

	 	Drug-Free Workplace (May 2001)
	 
	52.223-7

	 	Notice of Radioactive Materials (Jan 1997)
	 
	52.223-11

	 	Ozone-Depleting Substances (May 2001)
	 
	52.223-14

	 	Toxic Chemical Release Reporting (Aug 2003)
	 
	52.225-13

	 	Restrictions on Certain Foreign Purchases (Mar 2005)
	 
	52.226-1

	 	Utilization of Indian Organizations and Indian-Owned Economic Enterprises (Jun
2000)
	 
	52.227-1

	 	Authorization and Consent (Jul 1995)
	 
	52.227-2

	 	Notice and Assistance Regarding Patent and Copyright Infringement (Aug 1996)
	 
	52.227-3

	 	Patent Indemnity (Apr 1984)
	 
	52.227-14

	 	Rights in Data — General (Jun 1987)
	 
	52.227-14

	 	Alternate II (June 1987)
	 
	52.227-15

	 	Representation of Limited Rights Data and Restricted Computer Software (May 1999)
	 
	52.227-19

	 	Commercial Computer Software — Restricted Rights (Jun 1987)
	 
	52.229-3

	 	Federal, State, and Local Taxes (Apr 2003)
	 
	52.232-1

	 	Payments (Apr 1984)






35









 






	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.232-8

	 	Discounts for Prompt Payments (Feb 2002)
	 
	52.232-9

	 	Limitation on Withholding of Payments (Apr 1984)
	 
	52.232-11

	 	Extras (Apr 1984)
	 
	52.232-17

	 	Interest (Jun 1996)
	 
	52.232-18

	 	Availability of Funds (Apr 1984)
	 
	52.232-20

	 	Limitation of Cost (Apr 1984)
	 
	52.232-22

	 	Limitation of Funds (Apr 1984)
	 
	52.232-23

	 	Assignment of Claims (Jan 1986)
	 
	52.232-25

	 	Prompt Payment (Oct 2003)
	 
	52.232-33

	 	Payment by Electronic Funds Transfer — Central Contractor Registration (Oct 2003)
	 
	52.232-34

	 	Payment by Electronic Funds Transfer — Other Than Central Contractor
Registration (July 2004)
	 
	52.233-1

	 	Disputes (Jul 2002)
	 
	52.233-3

	 	Protest After Award (Aug 1996) “This clause is only applicable to the extent
provided by the Project Bioshield Act of 2004.”
	 
	52.233-3

	 	Protest After Award (Alternate I) (Jun 1985) “This clause is only applicable to
the extent provided by the Project Bioshield Act of 2004.”
	 
	52.242-1

	 	Notice of Intent to Disallow Costs (Apr 1984)
	 
	52.242-3

	 	Penalties for Unallowable Costs (May 2001)
	 
	52.242-4

	 	Certification of Final Indirect Costs (Jan 1997)
	 
	52.242-13

	 	Bankruptcy (Jul 1995)
	 
	52.243-1

	 	Changes — Fixed Price (Aug 1987)
	 
	52.243-1

	 	Changes — Alternate II Changes — Fixed-Price (Apr 1984)
	 
	52.243-2

	 	Changes — Cost-Reimbursement (Aug 1987)
	 
	52.244-2

	 	Subcontracts (Aug 1998)
	 
	52.244-2

	 	Subcontracts (Alternate II) (Aug 1998)
	 
	52.244-6

	 	Subcontracts for Commercial Items (July 2004)
	 
	52.245-2

	 	Government Property (Fixed-Price Contracts) (May 2004)
	 
	52.245-5

	 	Government Property (Cost-Reimbursement, Time-and-Material, or Labor-Hour
Contracts) (May 2004)
	 
	52.245-5

	 	Government Property (Cost-Reimbursement, Time-and-Material, or Labor-Hour
Contracts) (Alternate I) (Jun 2003)
	 
	52.246-23

	 	Limitation of Liability (Feb 1997)
	 
	52.246-24

	 	Limitation of Liability — High-Value Items (Feb 1997)
	 
	52.246-25

	 	Limitation of Liability — Services (Feb 1997)
	 
	52.248-1

	 	Value Engineering (Feb 2000)
	 
	52.249-2

	 	Termination for Convenience of the Government (Fixed-Price) (May 2004)
	 
	52.249-6

	 	Termination (Cost-Reimbursement) (May 2004)
	 
	52.249-8

	 	Default (Fixed-Price Supply and Service) (Apr 1984)






36









 






	 	 	 
	FAR SOURCE	 	TITLE AND DATE
	52.249-14

	 	Excusable Delays (Apr 1984)
	 
	52.253-1

	 	Computer Generated Forms (Jan 1991)
	 
	HHSAR SOURCE	 	TITLE AND DATE
	352.202-1

	 	Definitions (Jan 2001)
	 
	352.216-72

	 	Additional Cost Principles (Oct 1990)
	 
	352.224-70

	 	Confidentiality of Information (Apr 1984)
	 
	352.228-7

	 	Insurance — Liability to Third Persons (Dec 1991)
	 
	352.232-9

	 	Withholding of Contract Payments (Apr 1984)
	 
	352.233-70

	 	Litigation and Claims (Apr 1984)
	 
	352.242-71

	 	Final Decisions on Audit Findings (Apr 1984)
	 
	352.270-4

	 	Pricing of Adjustments (Jan 2001)
	 
	352.270-6

	 	Publications and Publicity (Jul 1991)
	 
	352.270-7

	 	Paperwork Reduction Act (Jan 2001)
	 
	352.270-8

	 	Protection of Human Subjects (Jan 2001)
	 
	352.270-9

	 	Care of laboratory animals (Sept 1985)






37









 






Section J — List of Attachments




	 	 	 	 	 
	Attachment #	 	Attachment Description	 	Number of Pages
	 
	J.1

	 	Billing Instructions for Cost Type Contracts
	 	4 pages
	 
	 	 	 	 
	J.2

	 	Notes to Offerors
	 	2 pages
	 
	 	 	 	 
	J.3

	 	Optional Form 310
Protection of Human
Subjects Assurance
	 	1 page
	 
	 	 	 	 
	J.4

	 	Text from Amendment
0004 to RFP clarifying
Amendment 0003.
	 	1 page
	 
	 	 	 	 
	J.5

	 	ACH Vendor Payment	 	1 page
	 
	 	 	 	 
	J.6

	 	Small Business Model
Subcontracting Plan
	 	7 pages







38









 







	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
	 	1. CONTRACT ID CODE	 	PAGE OF PAGES
	 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	1	11	 	 
	 	 	 	 	 	 
	2. AMENDMENT/MODIFICATION NO.
Modification 0001
	 	 3. EFFECTIVE DATE	 	 4. REQUISITION/PURCHASE REQ NO
	 5. PROJECT NO (If applicable.)
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	6. ISSUED BY	 	CODE	 	 	 	 7. ADMINISTERED BY (If other than Item 6.)
	 	CODE  	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	DHHS / OS OPHEP / ORDC	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	200 Independence Ave.	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SW, Room 636G
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Washington, DC 20201	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 
	8. NAME AND ADDRESS OF CONTRACTOR (No. street, county Sate and ZIP Code)	þ	 9A.	AMENDMENT OF SOLICITATION NO 
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Human Genome Sciences, Inc	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	14299 Shady Grove Road	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Rockville, MD 20850	 	 	 	 	 	 	 	 9B.	DATED (SEE ITEM 11)	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 þ	 	 10A. 
	MODIFICATION OF CONTRACT/ORDER NO
	 	 	 	 	 	 	 	 	 	 	HHSO100200500006C

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 10B.	 DATED (SEE ITEM 11)	 	 
	CODE	 	 	 	FACILITY CODE	 	 	 	 	 	09  /  23  /  05	 	 	 
	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 your 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 APPROPIRATION DATA (If required)




     TIN: 223178468      CAN: 1991535      Appropriation: 7560140       O.C. 26.11       $165,205,217.


 



13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS



IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14




						
	 	 	 	 
	CHECK
ONE  

	 	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 1O1A.
	 
	 	 	 	 	 
	 	 	 	 
	 

	 	 	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).
	 	 	 	 
	þ

	 	 	C
	 	THIS SUPPLEMENTAL AGREEMENT IS
ENTERED INTO PURSUANT TO AUTHORITY
OF: 

	 	 	 	 	FAR 52 243-1 Changes FAR 52 217-7 Options

	 	 	 	 
	 

	 	 	D
	 	OTHER (Specify type of modification and authority.)
	 
	 	 	 	 	 
	 	 	 	 





E. IMPORTANT: Contractor o is not, þ is required to sign this document and return  1  copies to the issuing office.



 




			
	14.

	 	DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section heading, including solicitation/contract, subject matter where feasible.)
	 
	 

	 	Purpose: To exercise an option for CLIN 0003A, CLIN 0003B, CLIN 0004, CLIN 0005, and the
design portion of CLIN 0008; and embed contract milestones into this contract and modification; and add an advanced understanding under article B 8 as described on page 2.
	 
	 	 
	 

	 	The funded amount is increased by $165,205,217 from $1,797,372, to $167,002,589.
	 

	 	The total contract amount is increased by $165,205,217 from $1,797,372 to $167,002,589.
	 

	 	The contract expiration date is extended from 9/22/06 to 9/22/09.






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 (Type or print)	 	 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)
	H. Thomas Watkins, Chief Executive Officer	 	 	 	Brian K. Goodger
	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	15B. CONTRACTOR/OFFEROR

	 	 15C. DATE SIGNED
	 	 16B. UNITED STATES OF AMERICA	 	 16C. DATE SIGNED
	/s/ H. Thomas Watkins	 	 6/19/06	 	  /s/ Brian K. Goodger	 	 6/19/06
	 
	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 
	(Signature of person authorized to sign)	 	 	 	(Signature of Contracting Officer)	 	 
	 
	 
	 	 	 	 	 	 	 	 





 
			
	NSN 7540-01 152-B070

Previous edition unusable
	 	STANDARD FORM 30 (REV 10-83)

Prescribed by GSA FAR (48 CFR) 53 243


















 









			
	 	 	 
	Contract Number HHSO100200500006C
	 	Modification 1, page 2 of 11
	HGS, Inc.	 	 





The purpose of this contract modification is to exercise an option for more quantity of product,
and add an advance understating under this modification.



THEREFORE, the contract is hereby modified as follows:



ARTICLE B.7 Optional CLINs are hereby exercised as follows:



CLIN 0003A is optioned for 20,001 units

CLIN 0003B is optioned for 1 Job

CLIN 0004 is optioned for 20,001 units

CLIN 0005 is optioned for 20,001 units

CLIN 0008 is optioned for the design portion only




	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	EXTENDED
	ITEM	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	UNIT PRICE	 	PRICE
	0003A

	 	The Contractor
shall manufacture
Anthrax Therapeutic
Product and label
as IND material.
	 	[***]


Thera-peutic
Courses of
Treatment
	 	[***]
	 	[***]
	 

	 	* In accordance
with the Project
Bio-Shield Act of
2004, the
Contractor will be
paid a discounted
price per unit of a
product that is not
licensed, cleared
or approved at the
time of delivery to
the USG as IND
material. The
contractor will be
paid an additional
amount under CLIN
0005 if the product
becomes licensed,
cleared, or
approved by FDA
before the
expiration date of
the contract.	 	 	 	 	 	 
	 	 	 
	 

	 	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.





 









 








			
	 	 	 
	Contract Number HHSO100200500006C
	 	Modification 1, page 3 of 11
	HGS, Inc.	 	 






	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	TOTAL EST.
	ITEM	 	SUPPLIES/SERVICES	 	QTY/UNIT	 	EST. COST	 	FIXED FEE	 	CPFF
	0003B

	 	Conduct Stability
and Potency
Testing, Advanced
Development/Pivotal
Studies, Submit
Regulatory
Submissions, Ship,
Store, and Dispose
of Product
	 	1 Job
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	The Contractor
shall perform
Stability & Potency
Testing, and
Conduct Advanced
Development/Pivotal
Studies, etc. in
accordance with
Requirements 3-7 of
the attached
Statement of Work.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	This is a Cost Plus
Fixed-Fee Line
Item.	 	 	 	 	 	 	 	 






	 	 	 	 	 	 	 	 	 
	 	 	 	 	QTY /	 	 	 	 
	ITEM	 	SUPPLIES / SERVICES	 	UNIT	 	UNIT PRICE	 	EXTENDED PRICE
	0004

	 	The Contractor
shall execute the
labeling strategy
to convert the
investigative phase
of the label to the
approved/licensed
label, in
accordance with the
attached Statement
of Work.
	 	[***]


Thera-peutic
Courses of
Treatment
	 	[***]
	 	[***]
	 

	 	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.





 









 






			
	 	 	 
	Contract Number HHSO100200500006C
	 	Modification 1, page 4 of 11
	HGS, Inc.	 	 






	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	UNIT	 	 
	ITEM	 	SUPPLIES / SERVICES	 	QTY / UNIT	 	PRICE	 	EXTENDED PRICE
	0005

	 	The Contractor
shall receive
payment, for
Anthrax Therapeutic
Product labeled as
FDA
approved/licensed
material, in
accordance with the
attached Statement
of Work.
	 	[***]


Thera-peutic
Courses of
Treatment
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 
	 

	 	The USG will
authorize an
additional payment
to the Contractor
once the
therapeutic courses
of treatment are
finalized as FDA
approved/licensed
material in
accordance with the
discounted payment
description in CLIN
0003A above.	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	This is a Firm
Fixed-Price Line
Item.	 	 	 	 	 	 






	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	TOTAL
	 	 	 	 	QTY/	 	EST.	 	FIXED	 	EST.
	ITEM	 	SUPPLIES / SERVICES	 	UNIT	 	COST	 	FEE	 	CPFF
	0008

	 	The Contractor shall Design

Phase 4 Post Studies
	 	1 Job
	 	[***]
	 	[***]
	 	[***]
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	Design and conduct Phase 4
post marketing studies to
verify and describe the
product’s clinical benefit
and assess safety when
used as indicated in
accordance with Section
C.5, Requirement 4, of the
Statement of Work.	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	This is a Cost Plus
Fixed-Fee 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.





 









 






			
	 	 	 
	Contract Number HHSO100200500006C
	 	Modification 1, page 5 of 11
	HGS, Inc.	 	 






ARTICLE B.8 Advance Understanding




Continued Economies of Scale:



If during the manufacturing run of the 20,001 units exercised above, the Government decides to
purchase an additional 10,000 units, the price would be [***].




FDA Meeting Minutes:



1. The Contractor shall forward the initial draft minutes and final draft minutes of any formal
meeting with the FDA to ORDC.



2. The Contractor shall forward the final draft minutes of any informal meeting with the FDA to
ORDC.



3. The Contractor shall forward the dates and times of any meeting with the FDA to ORDC.



4. The Contractor shall provide ORDC the opportunity to review and comment upon any questions to
be submitted to the FDA. The Contractor shall provide ORDC with a 48 hour period in which to
review and provide comments back to the Contractor.




Site Visits/Meetings/Man in Plant:



The Contractor shall provide for at least monthly site visits by the Government to the Contractor’s
facility at the request of ORDC.



The Contractor shall provide for weekly teleconferences with the Government at the request of ORDC.



The Contractor shall allow for a US Government representative to work one day per week in the
Contractors plant. This U.S. Government representative shall communicate any and all deviations in
the work plan to the Government Project Officer and Contracting Officer.




PCT:



The Contractor shall work in collaboration with ORDC to establish and participate on a PCT (Project
Coordination Team) that shall consist of monthly meetings unless otherwise requested by the
Government, which shall include the Contractor’s participation and may include multiple
organizations within the Department of Health & Human Services.




[***] 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.




 









 






			
	 	 	 
	Contract Number HHSO100200500006C
	 	Modification 1, page 6 of 11
	HGS, Inc.	 	 





Usable Product:



FDP produced from or following three consistency lots shall be used in animal and clinical studies
and shall be the product delivered to the SNS after completion of all necessary studies to fulfill
the “usable product” requirement of the contract. Three conformance lots shall be produced prior
to BLA application. If there is a difference in conformance lots compared to the earlier
consistency lots, the Contractor shall replace the product that is in the SNS with the new product
at no cost to the Government.




Further Clarification to page 32 (b. and c & J.4.1) of the Usable Product definition:



The definition of usable product found at H.23. of the contract is further clarified to state that
sufficient safety (non-clinical and clinical) and efficacy data (non-clinical and other FDA
requested tests) shall be submitted to the Contractor’s IND prior to delivery of immuno-therapeutic
to the SNS to support use of investigational product for the inhalational treatment indication by
the U.S. Government under an IND held by the CDC for contingency use protocol or an EUA. All
specifications outlined in the usable product definition will be the basis for FDA/CDER review and
concurrence that the product meets the usability criteria needed to initiate product delivery to
the SNS.




ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED