exv10w16






Exhibit 10.16








	ORDER FOR SUPPLIES OR SERVICES PAGE OF PAGES
1 2
IMPORTANT: [Mark ell packages and papers with contract and/or order numbers.]
I. DATEOFORDER            r. CONTRACT NO. (IF ANY) 6, SHIP TO:
November 4.2009 HHSO1 00201 000001 |a. NAME OF CONSIGNEE
REQUISITION/REFERENCE NO            TBD
}. ORDER NO.
001 os23204 b. STREETADDRESS ISSUING OFFICE (Address correspondence to)
HHS\OS\ASPR\BARDAc. CITYI. STATE e. ZIP CODE
        .TO: f. SHIP VIA
NAME OF CONTRACTOR
BioCryst Pharmaceuticals, Inc.8. TYPE OF ORDER
COMPANY NAME            fl a. PURCHASE! b. DELIVERY — Except for billing
REFERENCE YOUR:instructions on the reverse, this
STREETADDRESS
Please furnish the following!—on thedelivery order is subject to
2190 Parkway Lake Drive            on this side terms and conditions specified on both            instructions contained
d. CITY            STATE ZIP rides of this order and on the attached only
of this form and ¡s issued subject le. STATE if any, including delivery as to the terms
and conditions of the
indicated above-numbered contract.
Birmingham AL 35244-1879
9.ACCOUNTING AND APPROPRIATION DATA 10.. REQUISITIONING OFFICE
Appr.: 75X0140; F.Y.: 2010; HHS\OS\ASPR\BARDA
CAN: 1994009: O,C,: 26201; Value: $22,500,000.00
11. BUSINESS CLASSFICATION (Check appropriate box(es)) 12. F,O.B. POINT
a. SMALL b. OTHER THAN SMALL c. DISADVANTAGED g. service- Destination
d. WOMEN-OWNED e. HUBZone f. EMERGING SMALL            DISABLED
BUSINESS            VETERAN-OWNED
13. PLACE OF: 14. GOVERNMENT B/L NO. 15. DELIVER TO F.O.B. POINT ON 16. DISCOUNT TERMS
a. INSPECTION b. ACCEPTANCE N/A            OR BEFORE (Date) N/A
See Schedule
17. SCHEDULE (See Reverse for Rejections)
ITEM NO. SUPPLIES OR SERVICES QUANTITY UNIT UNIT AMOUNT QUANTITY .
ORDERED            PRICE            ACCEPTED
(a).(b) (c)(d)(e)(f) (g)
Treatment Courses (TC) of IV peramivir 10,00 TC $2250.00 $22,500,000.00
(Shipping information will be provided in the Quality Agreement
to be provided to the contractor in accordance with the contract specified in Item 2 above)
[Remainder of this block intentionally left blank]
18.SHIPPING POINT I9. GROSS SHIPPINGWEIGHT 20. INVOICE No.
SEE BILLING 17(h)TOT.
21. MAIL INVOICE TO:
N/A
a. NAME ¡Cont.
INSTRUCIION
s            pages)
RoseMary Mann
ON b. STREETADDRESS (or P.O. Box)
17(rl
330 Independence Ave. SW, Room G640
REYERSE
c. GITY            d. STATE
e. ZIP CODE GRANT
022,500,000.00
Washington DC 20201 TOTAL
23. NAME (Typed)




	22.UNITED STATES OF            RoseMary Mann
AMERICA BY (Signature) TITLE: CONTRACTING/ORDERING OFFICER
AUTHORIZD FOR LOCAL REPRODUCTION OPTIONAL FORM 347 (REV. 4/2006)
PREVIOUS EDITIONS NOT USABLE            Prescribed by GSA/FAR 48 CFR 53.213(f)



















 





Contract No.HHSO1002010000011

Task/Delivery Order No. 001

November 4, 2009

Page2 of 2



Product will be delivered to:



Service Supply Center

Bldg 14

Perry Point, MD 21902

POC: Steve Pearson

#410-642-2244



The Contactor is required to sign acceptance of this Task/Delivery Order and return one copy to
the Contracting Officer.




	 	 	 	 
	 
	 

	 	 	 
	Signature

	 	Date	 




















 









	AuwADrv/-*r>MTDA<~T I 1- THIS CONTRACT IS A RATED ORDER \ IRATING Ipage of pages AWARD/CONTRACT UNDER DPAS (15 CFR 700) \> j | 172. CONTRACT (Proc. Inst. Indent.) NO. 3. EFFECTIVE DATE |4. REQUISITION/PURCHASEREQUEST/PROJECT NO.HHSO100201000001I | 11-04-2009 |5. ISSUED BY CODE| HHS/OS/ASPR/BAR |
6- ADMINISTERED BY (If other than Item 5) CODE |HHS/OS/ASPR/BARDA 330 INDEPENDENCE AVE. SW ROOM G640 WASHINGTON DC 202017. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) ‘ |8. DELIVERYBIOCRYST PHARMACEUTICALS, INC D fob origin Pother (See below)2190 PARKWAY LAKE DRIVE 9- discount for prompt paymentBIRMINGHAM AL 35244-187910. SUBMIT INVOICES I ITEM(4copies unless othe
rwise ^\, . ¦ ^___specified) TO THE ^s’CODE FACILITY CODE ADDRESS SHOWN IN ^11. SHIP TO/MARK FOR CODeT 112. PAYMENT WILL BE MADE BY CODE~“SAME AS ITEM 713. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: — 14. ACCOUNTING ANDAPPROPRIATION DATAI 110 U.S.C. 2304(c) ( ) | | 41 U.S.C. 253(c) ( )15A. ITEMNOT 15B. SUPPLIES/SERVICES ?5C. QUANTITY |15D.UNIT|15E. UNIT PRI
CS 15F. AMOUNTINTRAVENOUS ANTIVIRAL DRUGPlease see Schedule for additional information 15G. TOTAL AMOUNT OF CONTRACT~T> $___^^ 16. TABLE OF CONTENTS(X) I SEC. I DESCRIPTION I PAGE(S)| (X) f SEC. f DESCRIPTION I PAGE(S)PART I — THE SCHEDULE PART II — CONTRACT CLAUSESX| A | SOLICITATION/CONTRACT FORM | X| ‘ I CONTRACT CLAUSES jX B SUPPLIES OR SERVICES AND PRICES/COSTS PART III — LIST OF DOCUMENTS, EXHIBITS AN
DOTHER ATTACH.X C DESCRIPTION/SPECS./WORK STATEMENT X| J | LIST OF ATTACHMENTSX D PACKAGING AND MARKING PART IV — REPRESENTATIONS AND INSTRUCTIONS X E INSPECTION AND ACCEPTANCE ^ REPRESENTATIONS, CERTIFICATIONS AND OTHER X F DELIVERIES OR PERFORMANCE ,, STATEMENTS OF OFFERORSX G CONTRACT ADMINISTRATION DATA L INSTRS., CONDS., AND NOTICES TO OFFERORSX H SPECIAL CONTRACT REQUIREMENTS M
EVALUATION FACTORS FOR AWARD CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE17. þ CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to 18. | | AWARD (Contractoris not required to sign this document.) Yourofferonsign this document and return ___copies to issuing office.) Contractor Solicitation Number ,agrees to furnish and deliver all items or perform all the services set forth or otherwiseincluding the additions or changes made by yo
u which additions or changes are set forth inidentified above and on any continuation sheets for the consideration stated herein. The fullabove, is hereby accepted as to the terms listed above and on any continuation sheets, rights andobligations of the parties to this contract shall be subject to and governed by the This awardconsummates the contract which consists of the following documents: (a) the following documents:(a) this award/contract, (b) the solicitation, if any, and (c) such Gove
rnment’s solicitation andyour offer, and (b) this award/contract. No further contractualprovisions, representations, certifications, and specifications, as are attached or document isnecessary.incorporated by reference herein. ‘Attachments are listed herein.)19A. NAME AND TITLE OF SIGNER (Type or Print) ‘ 20A. NAME OF CONTRACTING OFFICER^___ROSEMARY MANN19B. NAME OF CONTRACTOR |19C. DATE SIGNED 20B. UNITED STATES OF AMERICA |20C. DATE SIGNED ‘BY BY(Signature of person au
thorized to sign) (Signature of Contracting Officer)AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 26 (REV. 4/2008)Previous edition is usable Prescribed by GSA — FAR (48 CFR) 53.214(a)









 









 









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Contract # HHSO100201000001I

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SECTION B — SUPPLIES OR SERVICE AND PRICE / COST



ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES



The purchase of intravenous antiviral drugs is intended to safeguard the health of the severely
ill requiring hospitalization during a declared pandemic. This contract is to provide a certain
number of treatment courses of intravenous antiviral drugs as requested by HHS or other essential
government personnel to clinics providing critical care of influenza patients as a safeguard to
mitigate possible increases in morbidity and mortality arising from 2009 H1N1 infection.




ARTICLE B.2. PRICES





	a.	 	The prices set forth in this contract will cover the contract period of 24 months from the
date of award.






	b.	 	Upon delivery and acceptance of the item(s) described in SECTION C of this contract and
identified in the schedule of charges below, the Government shall pay to the Contractor the
unit price(s) set forth below in ARTICLE B.3.




ARTICLE B.3. SCHEDULE OF CHARGES




	 	 	 	 	 	 	 	 	 	 	 
	CLIN	 	Quantity	 	Unit Price	 	Total
	0001 - Antiviral Drug
	 	1,000 (treatment courses)	 	$	2,250.00	 	 	$	2,250,000.00	 
	 
	OPTIONAL CLIN*
	 	 	 	 	 	 	 	 	 	 
	0002 - Maximum Order
Antiviral Drug
	 	40,000 (treatment courses)	 	$	2,250.00	 	 	$	90,000,000.00	 








 




			
	*	 	The USG may order up to a maximum of 40,000 treatment courses if optional CLIN is exercised.




One ‘Treatment Course’ is defined as peramivir IV 600mg daily for 5 days.



ARTICLE B.4. CONTRACT TYPE



This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract. Firm Fixed Price Delivery/Task
orders will be issued against this contract. (See ARTICLE G.3. for additional ordering procedures).



ARTICLE B.5. ADVANCE UNDERSTANDINGS




Reserved



SECTION C — STATEMENT OF WORK (SOW)



ARTICLE C.1. DESCRIPTION



The near certainty that a novel strain of influenza virus will emerge at some time and cause
pandemic disease with significant U.S. and global public health impact has led the Department of
Health and




 









 





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Contract # HHSO100201000001I

Page 3 of 17



Human Services (HHS) to undertake an ambitious program to prepare countermeasures against
this threat. A key aspect of this preparedness strategy is to ensure the availability of antiviral
drugs against a pandemic strain in time to protect the U.S. population. For the past several
years, HHS, through the Biomedical Advanced Research and Development Authority (BARDA) in the
office of the Assistant Secretary for Preparedness and Response, has worked to build a stockpile
of antiviral drugs against viruses with pandemic potential. This year, a new virus with pandemic
potential unexpectedly emerged in Mexico and has rapidly spread around the world, causing
thousands of cases of disease as well as deaths in several countries. On April 26, 2009 the Acting
Secretary of HHS declared a public health emergency, indicating that the H1N1 2009 influenza virus
poses an imminent pandemic threat. On June 15, 2009, WHO declared H1N1 a pandemic threat. As of
September 5, 2009, the Centers for Disease Control and Prevention (CDC) reported 40,490 confirmed
cases of H1N1 2009 infection in the US.



Influenza antiviral drugs and vaccines are among the available countermeasures to decrease the
mortality and morbidity associated with the next pandemic. HHS is pursuing multiple and parallel
strategies to close the gap between current antiviral drug supply/demand and have stockpiled a
ready supply of antiviral drugs available for timely distribution.



Independently, and not as an agent of the USG, the Contractor shall furnish all the necessary
services, qualified personnel, materials, supplies, equipment, facilities, and transportation as
required to:





	a.	 	Manufacture treatment courses of antiviral drugs for delivery to the site requested.






	b.	 	Maintain ability to manufacture additional treatment courses dependent on the volume and size
of antiviral orders received from HHS for additional needs for either treatment or
prophylaxis.






	c.	 	Provide antiviral product and package labeling and packaging for finished product that is
consistent with CDC guidelines for stockpiled countermeasures.






	d.	 	Maintain integrity of antivirals while they are being transported from manufacturer to the
delivery sites pre-identified per order.






	e.	 	Provide report on product shipped to reflect delivery location, date of delivery, treatment
courses delivered, and lot numbers for full delivery.






	f.	 	Product will be accepted up to 6 months from the date of manufacture provided stability
testing data is supportive.




The Contractor shall honor only those orders for antiviral drugs that have been submitted by
Authorized Ordering Officials per contract.



ARTICLE C.2. MANUFACTURING



ARTICLE C.2.1. The contractor must have adequate facilities for manufacture, during the term of
the contract, of potentially licensable antiviral drug suitable for contingency use under an EUA,
including documentation of capacity for accomplishment of the stated activities and access to
facility(s) compliant with current Good Laboratory Practices, Good Manufacturing Practices, and
Good Clinical Practices regulations.




 









 





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ARTICLE C.2.2. The Contractor shall provide the Government with a current copy of their existing
security policy and procedures for the facility(s), included as Attachment C to this contract. The
Contractor shall provide to the Government access to its manufacturing facility for the purpose of
inspection. The Contractor shall arrange for the proper authorization and/or badges to facilitate
access for the Government representatives.



ARTICLE C.3. REGULATORY



ARTICLE C.3.1. All purchased product will adhere to cGMP, cGCP cGLP standards and practices.



ARTICLE C.3.2. All purchased product will not be used until an EUA has been issued and a PREP Act
Declaration occurs. Any and all conditions stipulated either by the EUA or the PREP Act
Declaration will apply.



ARTICLE C.3.3. A Quality Agreement will be established between the government and the Contractor
outlining roles and responsibilities for the handling and shipment of product.



ARTICLE C.4. BUSINESS MANAGEMENT



The Contractor shall have an integrated management plan for the entire manufacturing, production,
and shipment activities.



ARTICLE C.5. REPORTING REQUIREMENTS



Contractors shall notify the Contracting Officer or a duly authorized representative at least 24
hrs. beforehand that delivery of product will take place. Once delivery occurs and has been
accepted, contractors shall also notify designated HHS officials within 24 hrs. that product
acceptance has occurred.



SECTION D - PACKAGING, MARKING AND SHIPPING



ARTICLE D.1. PACKAGING OF PRODUCT



Packaging shall be consistent with standard packaging for this product. Packaging shall be
designed to promote quality during long-term controlled storage and transport in accordance with
the SOW.



ARTICLE D.2. MARKING



Marking shall be in accordance with FDA-approved labeling direction to be provided at the time of
the government places an order.



ARTICLE D.3. SHIPPING



Shipping shall be in accordance with the Quality Agreement to be negotiated between the government
and the contractor for the contract performance period. The Quality Agreement will include
delivery date and time, address where the order is to be delivered, and point of contact at
delivery location, in addition to other instructions specific to the contract.




 









 






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Contract # HHSO100201000001I

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SECTION E — INSPECTION AND ACCEPTANCE




	 	 	 
	FAR SOURCE	 	Title and Date
	FAR Clause 52.246-1

	 	Contractor Inspection Requirements (Apr 1984)
	 
	 	 
	FAR Clause 52.246-2

	 	Inspection of Supplies — Fixed Price ( Aug 1996)
	 
	 	 
	FAR Clause 52.246-16

	 	Responsibility for Supplies ( Apr 1984)





ARTICLE E.1. INSPECTION AND ACCEPTANCE



Inspection and acceptance of the articles, services, and documentation called for herein will be
accomplished by the Contracting Officer or a duly authorized representative at the destination of
the articles, services or documents.



SECTION F — DELIVERIES OR PERFORMANCE




	 	 	 
	FAR Source	 	Title and Date
	FAR Clause 52.211-17

	 	Delivery of Excess Quantities ( Sept 1989)
	 
	 	 
	FAR Clause 52.242-15

	 	Stop Work Order (Aug 1989)
	 
	 	 
	FAR Clause 52.242-15, Alt 1

	 	Stop Work Order, Alternate 1 (April 1984)
	 
	 	 
	FAR Clause 52.242-17

	 	Government Delay of Work (Apr 1984)
	 
	 	 
	FAR Clause 52.247-34

	 	FOB Destination (Nov 1991)





ARTICLE F.1. PERIOD OF PERFORMANCE



The period of performance of this contract is anticipated for twenty four months from date of
award.



ARTICLE F.2. PLACE AND METHOD OF DELIVERY





	a.	 	The delivery of the antiviral drugs and related supplies shall be F.O.B. Destination.
	 
	b.	 	The place of delivery will be provided to the Contractor no less than 24 hours prior to
shipping.
	 
	c.	 	Order Fulfillment and Delivery Criteria (from the Contractor’s proposal)
	 
	 	 	Through February 2010, if the government places an order(s) for up to 40,000 treatment courses,
the contractor can deliver these treatment courses in one to two weeks ONLY IF the contractor
has the inventory on-hand. If treatment courses are unavailable, up to 40,000 treatment courses
can be delivered in 12-16 weeks following an order
	 
	 	 	Beyond February 2010, if the government places an order, the contractor can deliver treatment
courses manufactured in August 2009 IF ON-HAND within one to two weeks if the government
chooses to accept product manufactured more than six months prior. If the government opts not
to take treatments manufactured in August 2009, it will take 12-16 weeks to manufacture and
deliver treatment courses.




ARTICLE F.3. REPORTING REQUIREMENTS




 









 





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ARTICLE F.3.1. Reporting Requirements



Reports shall be submitted in accordance with ARTICLE C.5. of the SOW.



ARTICLE F.3.2. Final Report



Within 30 days of 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.



ARTICLE F.3.3. Sample Inspection



At the discretion of the Government and independent of testing conducted by the Contractor, the
Government reserves the right to conduct site visits and collect samples of products manufactured
by the Contractor.



SECTION G — CONTRACT ADMINISTRATION



ARTICLE G.1. CONTRACTING OFFICER



1) 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.



2) The Contracting Officer is the only person with authority to act as agent of the Government
under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any
changes in the statement of work; (2) modify or extend the period of performance; (3) change the
delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the
performance of this contract; (5) obligate or deobligate funds into the contract; or (6) otherwise
change any terms and conditions of this contract.



3) 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.



ARTICLE G.2. PROJECT OFFICER/CONTRACTING OFFICER’S TECHNICAL
REPRESENTATIVE (COTR)



The Government’s Project Officer/COTR is:




     Dr. Kevin Gilligan, PhD


The Project Officer/COTR is responsible for: (1) monitoring the Contractor’s technical progress,
including the surveillance and assessment of performance and recommending to the Contracting
Officer changes in requirements; (2) interpreting the statement of work and any other technical
performance requirements; (3) performing technical evaluation as required; (4) performing
technical inspections and acceptances required by this contract; and (5) assisting in the
resolution of technical problems encountered during performance.



ARTICLE G.3. ORDERING PROCEDURES




 









 





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ARTICLE G.3.1. Method of Ordering



The Contracting Officer will sign all orders (including written confirmation of oral/telephonic
orders) involving requests for supplies and/or services under this contract. Each delivery shall
be accompanied by a packing slip or other evidence of delivery/performance.



ARTICLE G.3.2. Delivery Order and Task Order Type



Delivery orders and task orders issued under this contract will be firm-fixed
price.



ARTICLE G.3.3. Minimum and Maximum Quantity



The Government will order a MINIMUM of 1,000 treatment courses of the antiviral drugs.



The Government may order a MAXIMUM of 40,000 treatment courses of the antiviral drugs during the
contract period.



ARTICLE G.3.4. Multiple Award Ordering



Orders will be issued to all contractors awarded a contract under this solicitation. In the event
that multiple contracts are awarded, all contractors will receive orders up to the minimum
guaranteed quantity. Additional quantities may be ordered based upon Government’s need and the
contractor’s ability to produce the requirement and will be ordered on a competitive basis. The
Government reserves the right to make multiple awards.



ARTICLE G.3.5. Option for additional purchases



The Government may exercise options to fund the purchase of additional treatment courses of the
antiviral drugs in the quantity designated by the Contracting Officer at the time the Option is
exercised during the performance period of the contract at the unit price specified in the
contract.



ARTICLE G.3.6. Ordering Official



The Contracting Officer is the designated Ordering Official for this contract.



ARTICLE G.3.7. Applicable FAR Clauses



52.216-18 Ordering.



Ordering (Oct 1995)



(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of
delivery orders or task orders by the individuals or activities designated in the Schedule. Such
orders may be issued from November 4, 2009, to November 3, 2011.



(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In
the event of conflict between a delivery order or task order and this contract, the contract shall
control.




 









 





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(c) If mailed, a delivery order or task order is considered “issued” when the Government deposits
the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce
methods only if authorized in the Schedule.



(End of clause)



52.216-19 Order Limitations.



Order Limitations (Oct 1995)



(a) Minimum order. When the Government requires supplies or services covered by this contract in an
amount of less than 1000 treatment courses, the Government is not obligated to purchase, nor is the
Contractor obligated to furnish, those supplies or services under the contract.



(b) Maximum order. The Contractor is not obligated to honor—



(1) Any order for a single item in excess of 40,000 treatment courses;



(2) Any order for a combination of items in excess of 40,000 treatment courses; or



(3) A
series of orders from the same ordering office within 7 days that together call for
quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.



(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection
52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a
part of any one requirement from the Contractor if that requirement exceeds the maximum-order
limitations in paragraph (b) of this section.



(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order
exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned
to the ordering office within 2 days after Contractor receives the order, with written notice
stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon
receiving this notice, the Government may acquire the supplies or services from another source.



(End of clause)



52.216-22 Indefinite Quantity (Oct 1995)



(a) This is an indefinite-quantity contract for the supplies or services specified, and effective
for the period stated, in the Schedule. The quantities of supplies and services specified in the
Schedule are estimates only and are not purchased by this contract.



(b) Delivery or performance shall be made only as authorized by orders issued in accordance with
the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the
supplies or services specified in the Schedule up to and including the quantity designated in the
Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services
designated in the Schedule as the “minimum.”



(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule,
there is no limit on the number of orders that may be issued. The Government may issue orders
requiring delivery to multiple destinations or performance at multiple locations.



(d) Any order issued during the effective period of this contract and not completed within that
period shall be completed by the Contractor within the time specified in the order. The contract
shall govern the Contractor’s and Government’s rights and obligations with respect to that order to
the same extent as if the order were completed during the contract’s effective period; provided,
that the Contractor shall not be required to make any deliveries under this contract after
November 3, 2011.




 









 






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(End of clause)



ARTICLE G.4. PAYMENT BY ELECTRONIC FUNDS TRANSFER (Jan 2000)



The Government will use electronic funds transfer to the maximum extent possible when making
payments under this contract. FAR 52.232-33, Payment by Electronic Funds Transfer—Central
Contractor Registration, in Section I, requires the contractor to designate in writing a financial
institution for receipt of electronic funds transfer payments.



ARTICLE G.5. INVOICE SUBMISSION



The Contractor shall submit invoices in accordance with instructions provided in Attachment 1
— Invoice instructions.



ARTICLE G.6. PAYMENT CONDITIONS



The Contractor may not invoice for any CLIN prior to delivery.



Accepted product which falls into any of the following categories shall be replaced by the
contractor at no cost to the USG.





	 	1.	 	If product does not meet any criterion outlined in this contract.
	 
	 	2.	 	If product is deemed to be recalled for any reason, as outlined in the Product
Recalls, Including Removal and corrections published by U.S. Department of Health and
Human Services, Food and Drug Administration, Office of Regulatory Affairs; or based
upon Chapter 7 of the Regulatory Procedures Manual of March 2007.




ARTICLE G.7. CONTRACT COMMUNICATIONS/CORRESPONDENCE



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



ARTICLE G.8. POINT OF CONTACT



The Contractor shall provide primary and secondary points of contact that will be available 24
hours per day, 7 days per week, to be notified in case a public health emergency. (See Attachment
2)



SECTION H — SPECIAL CONTRACT REQUIREMENTS



ARTICLE H.1. CONFIDENTIALITY OF INFORMATION



The following information is covered by HHSAR Clause 352.224-70, Confidentiality of
Information (January 2006): Data obtained from human subjects.



ARTICLE H.2. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS



The contractor shall not conduct work involving select agents or toxins under this contract until
it and any associated subcontractor(s) comply with the following:





 












 





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	 	 	 	For prime or subcontract awards to domestic institutions that possess, use, and/or transfer
Select Agents under this contract, the institution must comply with the provisions of 42 CFR
part 73, 7 CFR part 331, and/or 9 CFR part 121
(http://www.aphis.usda.gov/programs/ag_selectagent/FinalRule3-18-05.pdf ) as
required, before using HHS funds for work involving a Select Agent or Toxin. No HHS funds
can be used for research involving a Select Agent or Toxin at a domestic institution without
a valid registration certificate.
	 
	 	 	 	For prime or subcontract awards to foreign institutions that possess, use, and/or transfer a
Select Agent or Toxin , before using HHS funds for any work directly involving a Select
Agent or Toxin , the foreign institution must provide information satisfactory to the HHS
that safety, security, and training standards equivalent to those described in 42 CFR part
73, 7 CFR part 331, and/or 9 CFR part 121 are in place and will be administered on behalf of
all Select Agent or Toxin work supported by these funds. The process for making this
determination includes inspection of the foreign laboratory facility by a HHS
representative. During this inspection, the foreign institution must provide the following
information: concise summaries of safety, security, and training plans; names of individuals
at the foreign institution who will have access to the Select Agents and procedures for
ensuring that only approved and appropriate individuals, in accordance with institution
procedures, will have access to the Select Agents under the contract; and copies of or links
to any applicable laws, regulations, policies, and procedures applicable to that institution
for the safe and secure possession, use, and/or transfer of select agents. No HHS funds can
be used for work involving a Select Agent or Toxin at a foreign institution without written
approval from the Contracting Officer.






	 	 	Listings of HHS select agents and toxins, and overlap select agents or toxins as well as
information about the registration process for domestic institutions, are available on the
Select Agent Program Web site at http://www.cdc.gov/od/sap/ and
http://www.cdc.gov/od/sap/docs/salist.pdf .






	 	 	Listings of USDA select agents and toxins as well as information about the registration process
for domestic institutions are available on the APHIS/USDA website at:

http://www.aphis.usda.gov/programs/ag_selectagent/index.html and:

http://www.aphis.usda.gov/programs/ag_selectagent/ag_bioterr_forms.html






	 	 	For foreign institutions, see the HHS Select Agent Award information:

( http://www.niaid.nih.gov/ncn/clinical/default_biodefense.htm ).





ARTICLE H.3. ANTI-LOBBYING



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 States 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





 









 








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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, FAR Clause 52.203-12 and HHSAR 352.270-10.



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 and State or Local
legislature.




ARTICLE H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING





	A.	 	Section 507 of P.L. 104-208 mandates that contractors funded with Federal dollars, in whole or
in part, acknowledge Federal funding when issuing statements, press releases, requests for
proposals, bid solicitations and other documents. Contractors are required to state (1) the
percentage and dollar amounts of the total program or project costs financed with Federal money,
and (2) the percentage and dollar amount of the total costs financed by nongovernmental sources.
	 
	 	 	This requirement is in addition to the continuing requirement to provide an acknowledgment of
support and disclaimer on any publication reporting the results of a contract funded activity.
	 
	B.	 	Publication and Publicity
	 
	 	 	The Contractor shall acknowledge the support of the Department of Health and Human Service,
Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and
Development Authority whenever publicizing the work under this contract in any media by including
an acknowledgment substantially as follows:  
“This project has been funded in whole or in part with
Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority, under HHSO100201000001I.
	 
	C.	 	Press Releases
	 
	 	 	Pursuant to Section 508 of Public Law 105-78, the contractor shall clearly state, when issuing
statements, press releases, requests for proposals, bid solicitations and other documents
describing projects or programs funded in whole or in part with Federal money that: (1) the
percentage of the total costs of the program or project which will be financed with Federal
money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage
and dollar amount of the total costs of the project or program that will be financed by
nongovernmental sources.




ARTICLE H.5. SUBCONTRACTING PROVISIONS


 









 











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Not applicable since BioCryst Pharmaceuticals, Inc. is a Small Business entity.




ARTICLE H.6. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE



Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in HHS
funded programs is encouraged to report such matters to the HHS Inspector General’s Office in
writing or on the Inspector General’s Hotline. The toll free number is 1-800-HHS-TIPS
(1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is
Htips@os.dhhs.gov and the mailing address is:



Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026




ARTICLE H.7. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES



The contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O.
13224 and P.L. 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.




ARTICLE H.8. NOTICE PRIOR TO PUBLICATION



The Contractor shall not release any reports, manuscripts, press releases, or abstracts
about the work being performed under this contract without written notice in advance to
the Government, for additional information see HHSAR 352.270-6.




ARTICLE H.9. 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 (HHS). HHS reserves the right to review any other data
determined by HHS 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.




ARTICLE H.10. 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 Contractor 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)





 









 








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as identified by CBER and CDER, the Contractor shall have thirty (30) calendar days from the time
such material failure is identified to cure such material failure. If the Contractor fails to take
such an action within the thirty (30) calendar day period, then the contract may be terminated.




ARTICLE H.11. PRESS RELEASES





	1.	 	Pursuant to Public Law(s) cited in paragraph (2), below, the contractor shall clearly state,
when issuing statements, press releases, requests for proposals, bid solicitations and other
documents describing projects or programs funded in whole or in part with Federal money: the
percentage of the total costs of the program or project which will be financed with Federal
money; the dollar amount of Federal funds for the project or program; and the percentage and
dollar amount of the total costs of the project or program that will be financed by
nongovernmental sources.





	 	 	 	 	 	 	 	 	 	 	 
	2.	 	Public Law and Section No.	 	Fiscal Year	 	Period Covered
	 	 	P.L. 109-149, Title V, section 506, as
Directed by P.L. 110-5, Div. B, title I,
Section 104
	 	 	2009	 	 	 	10/1/2009 - 9/30/2010	 






 









 







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PART II – CONTRACT CLAUSES




SECTION I — CONTRACT CLAUSES



FAR 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. Also, the full text of a clause may be accessed electronically at these addresses:



http://www.dhhs.gov/oamp/dap/hhsar.html

http://www.acqnet.gov

http://farsite.hill.af.mil/




I.1. General Clauses for a Negotiated Fixed Price Supply Contract





	a.	 	FEDERAL ACQUISITION REGULATION (FAR) (48 CHAPTER 1) CLAUSES





	 	 	 	 	 	 	 
	Reg	 	Clause	 	Date	 	Clause Title
	FAR
	 	52.202-1
	 	Jul-04
	 	Definitions (Over $100,000)

	FAR
	 	52.203-3
	 	Apr-84
	 	Gratuities (Over $100,000)

	FAR
	 	52.203-5
	 	Apr-84
	 	Covenant Against Contingent Fees (Over $100,000)

	FAR
	 	52.203-6
	 	Sep-06
	 	Restrictions on Subcontractor Sales to the Government (Over $100,000)

	FAR
	 	52.203-7
	 	Jul-95
	 	Anti-Kickback Procedures (Over $100,000)

	FAR
	 	52.203-8
	 	Jan-97
	 	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over $100,000)

	FAR
	 	52.203-10
	 	Jan-97
	 	Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)

	FAR
	 	52.203-12
	 	Sep-07
	 	Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)

	FAR
	 	52.204-4
	 	Aug-00
	 	Printed or Copied Double-Sided on Recycled Paper (Over $100,000)

	FAR
	 	52.204-7
	 	Apr-08
	 	Central Contractor Registration

	FAR
	 	52.204-10
	 	Sep-07
	 	Reporting Subcontract Awards ($500,000,000 or more)

	FAR
	 	52.209-6
	 	Sep-06
	 	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)

	FAR
	 	52.211-5
	 	Aug-00
	 	Material Requirements

	FAR
	 	52.215-2
	 	Mar-09
	 	Audit and Records — Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over $100,000 funded exclusively with non-Recovery Act funds.]

	FAR
	 	52.215-8
	 	Oct-97
	 	Order of Precedence — Uniform Contract Format

	FAR
	 	52.215-10
	 	Oct-97
	 	Price Reduction for Defective Cost or Pricing Data (Over $650,000)

	FAR
	 	52.215-12
	 	Oct-97
	 	Subcontractor Cost or Pricing Data (Over $650,000)

	FAR
	 	52.215-14
	 	Oct-97
	 	Integrity of Unit Prices (Over $100,000)

	FAR
	 	52.215-15
	 	Oct-04
	 	Pension Adjustments and Asset Reversions

	FAR
	 	52.215-18
	 	Jul-05
	 	Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

	FAR
	 	52.215-19
	 	Oct-97
	 	Notification of Ownership Changes

	FAR
	 	52.215-21
	 	Oct-97
	 	Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data — Modifications

	FAR
	 	52.219-8
	 	May-04
	 	Utilization of Small Business Concerns (Over $100,000)

	FAR
	 	52.219-9
	 	Apr-08
	 	Small Business Subcontracting Plan (Over $550,000, $1,000,000 for Construction)

	FAR
	 	52.219-16
	 	Jan-99
	 	Liquidated Damages — Subcontracting Plan (Over $550,000, $1,000,000 for Construction)

	FAR
	 	52.222-19
	 	Feb-08
	 	Child Labor—Cooperation with Authorities and Remedies

	FAR
	 	52.222-20
	 	Dec-96
	 	Walsh-Healey Public Contracts Act

	FAR
	 	52.222-21
	 	Feb-99
	 	Prohibition of Segregated Facilities







 









 







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	Reg	 	Clause	 	Date	 	 	Clause Title
	FAR	 	52.222-26	 	Mar-07	 	Equal Opportunity

	FAR	 	52.222-35	 	Sep-06	 	Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000)

	FAR	 	52.222-36	 	Jun-98	 	Affirmative Action for Workers with Disabilities

	FAR	 	52.222-37	 	Sep-06	 	Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Over $100,000)

	FAR	 	52.222-50	 	Feb-09	 	Combating Trafficking in Persons

	FAR	 	52.222-54	 	Jan-09	 	Employment Eligibility Verification (Over $100,000)

	FAR	 	52.223-6	 	May-01	 	Drug-Free Workplace

	FAR	 	52.223-14	 	Aug-03	 	Toxic Chemical Release Reporting (Over $100,000)

	FAR	 	52.225-1	 	Feb-09	 	Buy American Act — Supplies

	FAR	 	52.225-13	 	Jun-08	 	Restrictions on Certain Foreign Purchases

	FAR	 	52.227-1	 	Dec-07	 	Authorization and Consent

	FAR	 	52.227-2	 	Dec-07	 	Notice and Assistance Regarding Patent and Copyright Infringement

	FAR	 	52.229-3	 	Apr-03	 	Federal, State and Local Taxes (Over $100,000)

	FAR	 	52.232-1	 	Apr-84	 	Payments

	FAR	 	52.232-8	 	Feb-02	 	Discounts for Prompt Payment

	FAR	 	52.232-9	 	Apr-84	 	Limitation on Withholding of Payments

	FAR	 	52.232-11	 	Apr-84	 	Extras

	FAR	 	52.232-17	 	Oct-08	 	Interest (Over $100,000)

	FAR	 	52.232-23	 	Jan-86	 	Assignment of Claims

	FAR	 	52.232-25	 	Oct-08	 	Prompt Payment

	FAR	 	52.232-33	 	Oct-03	 	Payment by Electronic Funds Transfer—Central Contractor Registration

	FAR	 	52.233-1	 	Jul-02	 	Disputes

	FAR	 	52.233-3	 	Aug-96	 	Protest After Award

	FAR	 	52.233-4	 	Oct-04	 	Applicable Law for Breach of Contract Claim

	FAR	 	52.242-13	 	Jul-95	 	Bankruptcy (Over $100,000)

	FAR	 	52.243-1	 	Aug-87	 	Changes — Fixed-Price

	FAR	 	52.244-6	 	Mar-09	 	Subcontracts for Commercial Items

	FAR	 	52.249-2	 	May-04	 	Termination for the Convenience of the Government (Fixed-Price)

	FAR	 	52.249-8	 	Apr-84	 	Default (Fixed-Price Supply and Service)(Over $100,000)

	FAR	 	52.253-1	 	Jan-91	 	Computer Generated Forms







I.2. Department of Health and Human Services Acquisition Regulation (HHSAR) (48 CFR Chapter 3)
Clauses:



Full text of these clauses can be found at http://www.hhs.gov/oamp/policies/index.html




	 	 	 	 	 	 	 	 	 
	HHSAR	 	352.202-1	 	Jan-06	 	Definitions

	HHSAR	 	352.232-9	 	Jan-06	 	Withholding of Contract Payments

	HHSAR	 	352.270-4	 	Jan-01	 	Pricing of Adjustments

	HHSAR	 	352.270-5	 	Jan-06	 	Key Personnel

	HHSAR	 	352.270-6	 	Jan-06	 	Publications and Publicity

	HHSAR	 	352.270-10	 	Jan-06	 	Anti-Lobbying (Over $100,000)







I.3. ADDITIONAL CONTRACT CLAUSES




FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES



 









 








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	FAR	 	52.216-18	 	Oct-95	 	Ordering

	FAR	 	52.216-19	 	Oct-95	 	Order Limitations

	FAR	 	52.216-22	 	Oct-95	 	Indefinite Quantity

	FAR	 	52.216-27	 	Oct-95	 	Single or Multiple Awards

	FAR	 	52.227-14	 	Dec-07	 	Rights in Data — General

	FAR	 	52.232-20	 	Apr-84	 	Limitation of Cost

	FAR	 	52.232-32	 	Jan-08	 	Performance-based Payments

	FAR	 	52.242-1	 	Apr-84	 	Notice of Intent to Disallow Costs

	FAR	 	52.245-1	 	Jun-07	 	Government Property

	FAR	 	52.245-2	 	Jun-07	 	Government Property – Fixed Price Contracts

	FAR	 	52.249-2	 	May-04	 	Termination for the Convenience of the Government (Fixed-Price)

	FAR	 	52.249-8	 	Apr-84	 	Default (Fixed-Price Supply and Service) (Over $100,000)

	FAR	 	52.249-14	 	Apr-84	 	Excusable Delays









 




			
	(1)	 	52.217-7 Option for Increased Quantity — Separately Priced Line Item (Reserved) (Mar 1989).
	 
	 	 	“....The Contracting Officer may exercise the option by written notice to the Contractor within 24
hours of issuance of the contract ....”
	 
	(2)	 	52.215-17 Waiver of Facilities Capital Cost of Money (October 1997)
	 
	(3)	 	52.227-14, Rights in Data — General (Dec 2007)




 









 










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PART III – ATTACHMENTS 




SECTION J — LIST OF ATTACHMENTS



The following Attachments are provided in full text with this contract:



ATTACHMENT 1: INVOICE INSTRUCTIONS



ATTACHMENT 2: CONTRACTOR POINT OF CONTACT



ATTACHMENT 3: MANUFACTURING FACILITY SECURITY PLAN (Per ARTICLE C.2.2.)