Document:

Contract Number : HHSN272201400039C

 

CONTRACT TABLE OF CONTENTS

 

	PART I - THE SCHEDULE	4
	SECTION B - SUPPLIES OR SERVICES
    AND PRICES/COSTS	4
	ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	4
	ARTICLE B.2. ESTIMATED COST - OPTION	5
	ARTICLE B.3. ADVANCE UNDERSTANDINGS	7
	ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS	9
	SECTION C - STATEMENT OF WORK	10
	ARTICLE C.1. STATEMENT OF WORK	10
	ARTICLE C.2. REPORTING REQUIREMENTS	10
	ARTICLE C.3. INVENTION REPORTING REQUIREMENT	15
	SECTION D - PACKAGING, MARKING
    AND SHIPPING	15
	SECTION E - INSPECTION AND
    ACCEPTANCE	16
	SECTION F - DELIVERIES OR PERFORMANCE	16
	ARTICLE F.1. PERIOD OF PERFORMANCE	16
	ARTICLE F.2. DELIVERIES	17
	ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)	17
	SECTION G - CONTRACT ADMINISTRATION
    DATA	17
	ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)	17
	ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)	18
	ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT	18
	ARTICLE G.4. INDIRECT COST RATES	20
	ARTICLE G.5. GOVERNMENT PROPERTY	20
	ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	20
	SECTION H - SPECIAL CONTRACT
    REQUIREMENTS	21
	ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)	21
	ARTICLE H.2. HUMAN SUBJECTS	21
	ARTICLE H.3. RESTRICTION ON USE OF HUMAN SUBJECTS, HHSAR 352.270-6 (January 2006)	21
	ARTICLE H.4. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS	22
	ARTICLE H.5. DATA AND SAFETY MONITORING IN CLINICAL TRIALS	22
	ARTICLE H.6. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV	23
	ARTICLE H.7. HUMAN MATERIALS	23
	ARTICLE H.8. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)	23
	ARTICLE H.9. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES (Including Human Gene Transfer Research)	23
	ARTICLE H.10. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH	24
	ARTICLE H.11. NEEDLE DISTRIBUTION	24
	ARTICLE H.12. ACKNOWLEDGEMENT OF FEDERAL FUNDING	24
	ARTICLE H.13. RESTRICTION ON ABORTIONS	24
	ARTICLE H.14. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH	24

 

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Contract Number : HHSN272201400039C

 

	ARTICLE H.15. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION	25
	ARTICLE H.16. PRIVACY ACT, HHSAR 352.224-70 (January 2006)	25
	ARTICLE H.17. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)	25
	ARTICLE H.18. ANIMAL WELFARE	26
	ARTICLE H.19. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES	26
	ARTICLE H.20. OMB CLEARANCE	26
	ARTICLE H.21. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS OMB CLEARANCE	26
	ARTICLE H.22. GUN CONTROL OMB CLEARANCE	26
	ARTICLE H.23. CERTIFICATION OF FILING AND PAYMENT OF TAXES OMB CLEARANCE	27
	ARTICLE H.24. OPTION PROVISION	27
	ARTICLE H.25. INFORMATION AND PHYSICAL ACCESS SECURITY	27
	ARTICLE H.26. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010)	32
	ARTICLE H.27. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST	33
	ARTICLE H.28. PUBLICATION AND PUBLICITY	35
	ARTICLE H.29. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	35
	ARTICLE H.30. YEAR 2000 COMPLIANCE	35
	ARTICLE H.31. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES	35
	ARTICLE H.32. SHARING RESEARCH DATA	36
	ARTICLE H.33. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS	36
	ARTICLE H.34. HIGHLY PATHOGENIC AGENTS	37
	ARTICLE H.35. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)	37
	ARTICLE H.36. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES	37
	ARTICLE H.37. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD	37
	ARTICLE H.38. USE OF FUNDS FOR PROMOTIONAL ITEMS	38
	PART II - CONTRACT CLAUSES	39
	SECTION I - CONTRACT CLAUSES	39
	PART III - LIST OF DOCUMENTS,
    EXHIBITS AND OTHER ATTACHMENTS	46
	SECTION J - LIST OF ATTACHMENTS	46
	1. Statement of Work	46
	2. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4	46
	3. Cumulative Inclusion Enrollment Report	46
	4. Privacy Act System of Records, Number	46
	5. Safety and Health	46
	6. Research Patient Care Costs	46
	7. Disclosure of Lobbying Activities, SF-LLL	46
	8. Roster of Employees Requiring Suitability Investigations	46
	9. Employee Separation Checklist	46
	PART IV - REPRESENTATIONS AND
    INSTRUCTIONS	47
	SECTION K - REPRESENTATIONS
    AND CERTIFICATIONS	47
	1. Annual Representations and Certifications	47
	2. Annual Representations and Certifications, FAR Clause 52.204-8	47
	3. Human Subjects Assurance Identification Number	47
	4. Animal Welfare Assurance Number	47

 

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Contract Number : HHSN272201400039C

 

PART
I - THE SCHEDULE

 

SECTION
B - SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

The objective of this contract is to support
the advanced development of candidate products, which consist of a vaccine component in combination with a dry formulation technology
(also referred to as solid vaccine formulations), that increase duration of stability and minimize cold chain or preservative requirements.
These products will likely be used to minimize the need for preservatives for in post-event settings following the intentional
release of NIAID Category A, B and C Priority Pathogens or in response to naturally occurring outbreaks of infectious diseases
caused by NIAID Category A, B and C Priority Pathogens.

 

ARTICLE B.2. ESTIMATED COST - OPTION

 

	a.	The estimated cost of the Base Period of this contract is [*****].
	b.	The fixed fee for the Base Period of this contract is [*****]. The fixed fee shall be paid
in installments based on fee payment schedule paragraph f. of this Article. Payment shall be subject to the withholding provisions
of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this
contract.
	c.	The
                                         total estimated amount of the contract, represented by the sum of the estimated cost
                                         plus the fixed fee for the Base Period is $5,841,498.
	d.	If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of
this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee
will be increased as follows:

 

	 	 	Estimated
    Cost 
($)	 	 	Fixed
    Fee 
($)	 	 	Estimated
    Cost
 Plus Fixed Fee 
($)	 
	Base Period (exercised)	 	 	[*****]	 	 	 	[*****]	 	 	 	5,841,498	 
	Option Period
    1	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Option Period
    2	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Option Period
    3	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Option Period
    4	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Option Period
    5	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Option Period
    6	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Option Period
    7	 	 	[*****]	 	 	 	[*****]	 	 	 	[*****]	 
	Total
    
(Base Period and Options)	 	 	[*****]	 	 	 	[*****]	 	 	$	24,733,014	 

 

 

	e.	Payments
                                         will be made from the following PRISM/NBS Line Items as follows:

 

	PRISM/NBS
    

Line Item No.	 	Option/Increment
     Description	 	PRISM/NBS
    Line Item  Period of Performance	 	 	Funded
                                         Amount	 
	Line 1	 	Base Period	 	8/18/2014 - 8/17/2016	 	 	$5,841,498	 

 

	Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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Contract Number : HHSN272201400039C

 

f. Fee Payment Schedule Based on Contract Milestones:

 

The Contractor shall
complete all work in accordance with the Statement of Work and the contract milestones set forthherein. The distribution of the
fixed fee shall be paid in installments based on the COR's written certification regarding the completion of these milestines
(Tasks) as follows:

 

	 	Period
                                         of Performance	 	 	Task
    Number	 	Task
    Description	 	Deliverable	 	 	Fee	 
	 	Base	 	 	1.1.2.1.1. and 1.1.3.1.1.	 	Complete BDS and FPD technology transfer	 	Upon Completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Base	 	 	1.1.2.2.1.1., 1.1.2.2.1.2., 1.1.2.2.1.3., 1.1.2.2.1.4.,
    1.1.3.2.1.1., 1.1.3.2.1.2., 1.1.3.2.1.3., and 1.1.3.2.1.4.	 	Complete pilot BDS, pilot liquid FDP, and pilot
    lymphilized FDP manufacturing	 	Upon Completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Base	 	 	1.2.1.2. and 1.2.1.4.	 	Complete partial assay transfer/ qualification
    - Phase 1	 	Upon Completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Base	 	 	1.1.2.2.1.5.1., 1.1.2.2.1.5.4., 1.1.2.2.1.5.5.,
    1.1.2.2.1.5.6., 1.1.2.2.1.5.7., 1.1.2.2.1.5.8., and 1.1.2.2.1.5.9.	 	Pilot BDS Stability (25C/40C/freeze thaw), Pilot
    Lyo & Liquid Stability	 	Upon Completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Option
                                         1	 	 	1.2.1.2., 1.2.1.3, and 1.2.1.4.	 	Complete assay transfer/qualification - Phase
    2	 	Upon completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Option
                                         1	 	 	1.2.2.2., 1.2.2.8., 1.2.2.9., 1.2.2.10, 1.2.2.11,
    1.2.2.11, 1.2.2.12, 1.2.2.13, 1.2.2.17, and 1.2.2.23.	 	Complete pilot NHP study	 	Upon completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Option
                                         1	 	 	1.2.6.2, 1.2.6.8, 1.2.6.13, 1.2.6.14., and 1.2.6.20.	 	Complete passive transfer study (pilot NHP)	 	Upon completion of the task as described in the
    SOW	 	 	[*****]	 
	 	Option
                                         2	 	 	1.1.2.1.2. and
    1.1.3.1.2.	 	Complete BDS
    & FDP technology transfer	 	Upon completion
    of the task as described in the SOW	 	 	[*****]	 
	 	Option
                                         2	 	 	1.1.2.2.2.1.,
    1.1.2.2.2.2.,     1.1.1.2.2.3., 1.1.2.2.2.4., 1.1.2.2.2.5., 1.1.2.2.2.6., 1.1.2.2.2.7., 1.1.2.2.2.8., 1.1.3.2.3.1.,    

1.1.3.2.3.2.,
1.1.3.2.3.3., and

1.1.3.2.3.4.

	 	Complete release of BDS
    and lyophilized vaccine	 	Upon completion of the task
    as described in the SOW	 	 	[*****]	 

 

	Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

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Contract Number : HHSN272201400039C

 

	 	Period of Performance	 	 	Task Number	 	Task Description	 	Deliverable	 	 	Fee	 
	 	Option 2	 	 	1.1.2.2.2.9. and 1.1.3.2.3.5.	 	Stability - Engineering BDS & Liquid/ Lyophilized FDP	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 3	 	 	1.2.4.2., 1.2.4.8., 1.2.4.9., 1.2.4.10., 1.2.4.11, 1.2.4.11., 1.2.4.12, 1.2.2.13, 1.2.4.17, and 1.2.4.23.	 	Complete NHP1 Study	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 3	 	 	1.2.8.2, 1.2.8.8., 1.2.8.13., 1.2.8.14., and 1.2.8.20.	 	Complete passive transfer study (NHP1)	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 3	 	 	1.2.3.2., 1.2.3.8., 1.2.3.9., 1.2.3.10, 1.2.3.14., and 1.2.3.20.	 	Complete GLP toxicology study	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 3	 	 	1.2.7.2., 1.2.7.8., 1.2.7.13., 1.2.7.14., and 1.2.7.20.	 	Complete passive transfer study (GLP toxicology study)	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 4	 	 	1.4.2.1.1., 1.4.2.1.3., and 1.4.2.1.4.	 	Pre-IND meeting	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 4	 	 	1.3.1.1.,1.3.1.2., 1.4.3.1. and 1.4.3.6.	 	IND Submission	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 5	 	 	1.1.2.2.3.1., 1.1.2.2.3.1, 1.1.1.2.3.3., 1.1.2.2.3.4., 1.1.3.2.4.1., 1.1.3.2.4.2., 1.1.3.2.4.2., 1.1.3.2.4.3., 1.1.3.2.4.4., 1.1.3.2.5.1., 1.1.3.2.5.2., 1.1.3.2.5.3., and 1.1.3.2.5.4.	 	Complete release of BDS, liquid, and lyophilized vacine	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 5	 	 	1.1.2.2.3.5., 1.1.3.2.4.5., and 1.1.3.2.3.5.	 	Stability BDS, liquid, and lyo	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 5	 	 	1.1.4.	 	NIAID Requested Deliverables	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 6	 	 	1.2.5.2., 1.2.5.8., 1.2.5.9., 1.2.5.10., 1.2.5.11., 1.2.5.12., 1.2.5.13., 1.2.5.17., and 1.2.5.23.	 	Complete NHP2 Study	 	Upon completion of the task as described in the SOW	 	 	[*****]	 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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Contract Number : HHSN272201400039C

	 	Period of Performance	 	 	Task Number	 	Task Description	 	Deliverable	 	 	Fee	 
	 	Option 6	 	 	1.2.9.2., 1.2.9.8., 1.2.9.13., 1.2.9.14., and 1.2.9.20.	 	Complete passive transfer study (NHP2)	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 7	 	 	1.3.2.2., 1.3.2.3., 1.3.2.4., 1.3.2.5., 1.3.2.6., 1.3.2.7., 1.3.2.8., 1.3.2.9., 1.3.2.10., 1.3.2.11., 1.3.2.12., 1.3.2.13., 1.3.2.14., 1.3.2.15., 1.3.2.16., 1.3.2.17., and 1.3.2.18.	 	Phase 1 study - first patient enrolled	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 7	 	 	1.3.2.18.2., 1.3.2.18.3., 1.3.2.19., 1.3.2.20.	 	Phase 1 study - Complete (Results reported)	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	Option 7	 	 	1.2.10.2., 1.2.10.8., 1.2.10.13., 1.2.10.14., and 1.2.10.20.	 	Complete passive transfer study (Phase 1 study)	 	Upon completion of the task as described in the SOW	 	 	[*****]	 
	 	TOTAL	 	 	 	 	 	 	 	 	 	[*****]	 

 

ARTICLE B.3. ADVANCE UNDERSTANDINGS

 

Other provisions of this contract notwithstanding,
approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting
Officer.

 

	a.	Subcontract
	 	 
		1. To negotiate a subcontract agreement with"> [*****]for an amount not to exceed [*****], inclusive of options.

                                     

                                    Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

	 	 

		2. To negotiate a subcontract agreement with
    [*****] for an amount not to exceed [*****], inclusive
    of options. 

    

    Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the
    supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract
    by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.
	 	 

		3. To negotiate a subcontract agreement
    with [*****]for an amount not to exceed [*****] inclusive
    of options. 

    

    Award of the subcontract shall not proceed without the prior written consent of the
    Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving
    written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be
    provided to the Contracting Officer.

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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Contract Number : HHSN272201400039C

 

		4. To
    negotiate a subcontract agreement with [*****]for
    an amount not to exceed [*****], inclusive of options.

    
Award of the subcontract shall not proceed
without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause
52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed
subcontract shall be provided to the Contracting Officer.

	 	 
	 	5.To
    negotiate a subcontract agreement with [*****]for an amount not to exceed
    [*****], inclusive of options.
 
 Award
    of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the
    supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by
    the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.
	 	 
	 	6.To
                                         negotiate a subcontract agreement with [*****]for
                                         an amount not to exceed [*****], inclusive of
                                         options. 

                                         

                                         Award of the subcontract shall not proceed without the prior written consent of the Contracting
                                         Officer upon review of the supporting documentation required by FAR Clause 52.244-2,
                                         Subcontracts. After receiving written consent of the subcontract by the Contracting Officer,
                                         a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

  

	b.	Contract Number Designation
	 	 
	 	On all correspondence submitted under this
contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:
	 	 
	 	Contract
No. HHSN272201400039C.
	 	 
	c.	Advance Copies of Press Releases
	 	 
	 	The contractor agrees to accurately and factually represent the work conducted under this contract
    in all press releases. In accordance with NIH Manual Chapter 1754, misrepresenting contract results or releasing information
    that is injurious to the integrity of NIH may be construed as improper conduct. The complete text of NIH Manual Chapter 1754
    can be found at: http://www1.od.nih.gov/oma/manualchapters/management/1754/
	 	 
	 	Press releases shall be considered to include
the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that
the Contracting Officer's Representative (COR) has received an advance copy of any press release related to this contract not less
than four (4) working days prior to the issuance of the press release.

	 	 
	d.	Indirect Costs

 

		1. The Contractor may bill indirect costs at temporary billing rates as follows:

Fringe Benefits =[*****] of Direct
Labor

G&A = [*****] of Other Direct
Costs and Total Labor excluding Consultants and Subcontracts

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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Contract Number : HHSN272201400039C

 

		These temporary rates may be utilized until such time as indirect cost rates have been established, provided, that the Contractor's
indirect cost proposal is submitted to the cognizant office responsible for negotiating indirect costs no later than three (3)
months after the effective date of this contract. If the indirect cost proposal is not submitted by that time, any temporary indirect
costs billed after this due date will be suspended until such time as the indirect cost proposal is submitted.
	 	 
	 	2. The final amount reimbursable for indirect
costs shall not exceed the following rates. Once indirect costs rates have been established, these ceilings may be renegotiated
between the Contractor and the Contracting Officer and the ceilings lifted:

Fringe Benefits:
[*****]

G&A:
[*****]

	 	 
	 	The Government is not obligated to pay any additional
amount should the negotiated indirect cost rates exceed these ceiling rates. In the event that the negotiated indirect cost rates
are less than these ceilings rates, the Government's obligation should shall be reduced to conform to the lower rate.

 

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT
COSTS

 

	a.	Items Unallowable Unless Otherwise Provided

 

		Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated in this contract, unless authorized in writing
by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

 

		1.	Conferences and Meetings
	 	 	 
		2.	Food for Meals, Light Refreshments, and Beverages
	 	 	 
		3.	Promotional Items [includes, but is not limited to: clothing and commemorative items such
as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees,
or conference attendees.]
	 	 	 
		4.	Acquisition, by purchase or lease, of any interest in real property;
	 	 	 
		5.	Special rearrangement or alteration of facilities;
	 	 	 
		6.	Purchase or lease of any item of general purpose office furniture or office equipment regardless
of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than
research, such as office equipment and furnishings, pocket calculators, etc.);
	 	 	 
		7.	Travel to attend general scientific meetings;
	 	 	 
		8.	Foreign travel;
	 	 	 
		9.	Consultant costs;
	 	 	 
		10.	Subcontracts;
	 	 	 
		11.	Patient care costs;
	 	 	 
		12.	Accountable Government Property (defined as non-expendable personal property with an acquisition
cost of $1,000 or more and "sensitive items" (defined as items of personal property (supplies and equipment that are
highly desirable and easily converted to person use), regardless of acquisition value.

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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Contract Number : HHSN272201400039C

 

b.
Travel Costs

 

		1.	Domestic Travel
	 	 	 
	 	 	Total
                                         expenditures for domestic travel (transportation, lodging, subsistence, and incidental
                                         expenses) incurred in direct performance
                                         of this contract shall not exceed
                                         [*****]without
                                         the prior written approval of the Contracting Officer.

	 	 	 
		2.	The Contractor shall invoice and be reimbursed for all travel costs in accordance with Federal
Acquisition Regulations (FAR) 31.2 - Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs.

 

SECTION C - STATEMENT OF WORK 

ARTICLE C.1. STATEMENT
OF WORK

 

		a.	Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work, dated September 16, 2014, set forth in SECTION J-List of Attachments, attached hereto and made a part of
this contract.
	 	 	 
		b.	Privacy Act System of Records Number 09-25-0200 is applicable to this contract and shall
be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall
be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

 

ARTICLE C.2. REPORTING REQUIREMENTS

 

All reports required herein
shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

 

All
electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about
testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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a. Technical
Reports 

 

In addition to those reports required by the other terms
of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with
the DELIVERIES Article in SECTION F of this contract:

 

[Note:
Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central
(PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

 

	 	1.	Monthly Progress Report
	 	 	 

		This report shall include a description of the activities
during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists
of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist
of each calendar month.
	 	 

		The first report shall be due October 20, 2014. Thereafter,
reports shall be due on or before the 20th Calendar day following each reporting period.
	 	 

	 	2.	Annual Progress Report
	 	 	 

		This report shall include a summation of the results of the
entire contract work for the period covered. An annual report will not be required for the period when the Final Report is due.
A Monthly Report shall not be submitted when an Annual Report is due.
	 	 

		The first report shall cover the period August 18, 2014 through
August 17, 2015 of this contract and shall be due on/before 30 days after the Anniversary Date of the Contract.

 

	 	3.	Annual Technical Progress Report for Clinical Research
Study Populations

 

The
Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations for each
study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment
entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor
also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report.

 

The
Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract. In addition, the NIH
Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies.
The Guidelines may be found at the following website:

 

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

 

Include
a description of the plans to conduct analyses, as appropriate, by sex/gender and/or racial/ ethnic groups in the clinical trial
protocol as approved by the IRB, and provide a description of the progress in the conduct of these analyses, as appropriate, in
the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect,
indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis
in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender
and race/ethnicity.

 

4.
  Final Report

 

This
report is to include a summation of the work performed and results obtained for the entire contract period of performance.
This report shall be in sufficient detail to describe comprehensively the
results achieved. The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this
contract. An Annual report will not be required for the period when the Final Report is due.

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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Contract Number : HHSN272201400039C

 

The Contractor
shall provide the Contracting Officer with one electronic copy of the Final Report in draft form (in accordance with the
DELIVERIES Article in SECTION F of this contract 30 Calendar days prior to the expiration date of this contract.) The Contracting
Officer's Representative (COR) will review the draft report and provide the Contracting Officer with comments within 15 Calendar
days after receipt. The Final Report shall be corrected by the Contractor, if necessary and the final version delivered as specified
in the above paragraph.

 

5.   Summary
of Salient Results

 

The Contractor shall submit, with the
Final Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

 

6.    Reporting
on Select Agents or Toxins and/or Highly Pathogenic Agents

 

For work involving the possession, use,
or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be
included in each AnnualProgress Report: 

 

1.   Any
changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a Highly Pathogenic
Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable,
as determined by the IBC or equivalent body or institutional biosafety official.

 

		2.	If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent
will be conducted in the upcoming reporting period, provide:

		a.	A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will
be studied;
	 	 	 
		b.	A
                                         brief description of the work that will be done with each new or additional Select Agent
                                         or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent
                                         or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part
                                         73, Section 13.b (http://www.selectagents.gov/Regulations.html) or listed on the
                                         U.S. National Select Agents Registry restricted experiments website (http://www.selectagents.gov/
                                         Select%20Agents%20and%20Toxins%20Restricted%20Experiments.html);
	 	 	 
		c.	The name and location for each biocontainment resource/facility, including the name of the organization
that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by
your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or
different location.
	 	 	 
		d.	For work with Select Agents performed in the U.S. provide
documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents
performed in a non-U.S. country prior NIAID approval is required.

 

If the IBC or equivalent body or institutional
biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned
to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that
affect shall be included in each Annual Progress Report.

 

If no work involving a Select Agent or Toxin and/or
a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall
be included in each Annual Progress Report.

 

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Contract Number : HHSN272201400039C

 

b. Other Reports/Deliverables

 

1.   Information Security and Physical
Access Reporting Requirements

 

   The Contractor shall submit the following
reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed
below includes a reference to the appropriate subparagraph of this article.

 

a. Roster of Employees Requiring
Suitability Investigations

 

The Contractor shall submit a roster, by
name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the
contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall
be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days
of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in
SECTION H of this contract.)

 

b.IT Security Plan (IT-SP)

 

In
accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall
submit the IT-SP within thirty (30) days after the project kickoff meeting. The IT-SP shall be consistent with, and further detail
the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP
shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that
are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall
specify those parts of the contract to which the IT-SP applies.

 

The Contractor shall
review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information
Systems and Organizations, on an annual basis.

 

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article
in SECTION H of this contract.)

 

c.IT Risk Assessment (IT-RA)

 

In accordance with HHSAR Clause 352.239-72,
Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty (30) days
after the project kickoff meeting. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide
for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and
Privacy Policy.

 

The Contractor shall update the IT-RA on
an annual basis.

 

(Reference subparagraph D.c.2. of the INFORMATION
AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

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Contract Number : HHSN272201400039C

 

d.FIPS 199 Assessment

 

In accordance with
HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS
199 Assessment within thirty (30) days after the project kickoff meeting. The FIPS 199 Assessment shall be consistent with the
cited NIST standard.

 

(Reference subparagraph D.c.3. of the INFORMATION
AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

 

e.IT
Security Certification and Accreditation (IT-SC&A)

 

In accordance with HHSAR Clause 352.239-72,
Security Requirements For Federal Information Technology Resources, the Contractor shall submit written proof to the Contracting
Officer that an IT-SC&A was performed within three (3) months after contract award.

 

The Contractor shall perform an annual security
control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

 

(Reference subparagraph D.c.4. of the INFORMATION
AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

f.Reporting
of New and Departing Employees

 

The Contractor shall notify the Contracting
Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require
suitability determinations as follows:

		a.	New Employees who have or will have access to HHS Information systems or data: Provide
the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability
level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government
will determine the appropriate security level.
	 	 	 
		b.	Departing Employees: 1) Provide the name, position
title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in
the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor
employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

 

(Reference subparagraph E.2.a-c. of the INFORMATION
AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

g.Contractor
- Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to
Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access
to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/
Nondisclosure.pdf.

 

(Reference
subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

 

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Contract Number : HHSN272201400039C

 

2.Section
508 Annual Report

 

The
contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION
TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing
the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information
and Documents."

 

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

 

All reports and documentation
required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but
not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be
directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive,
Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report,
and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see
FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

 

The annual utilization report shall be submitted
in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii))
shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

 

Contracting Officer

National Institutes of Health

National Institute of Allergy and Infectious
Diseases

DEA, Office of Acquisition

6700B Rockledge Drive, Room 3108

Bethesda, Maryland 20892- 7612

 

If no
invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period,
a negative report shall be submitted to the Contracting Officer at the address listed above.

 

To
assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison,"
an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and
greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted
is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web (http://www.iedison.gov),
or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

 

SECTION D - PACKAGING, MARKING AND SHIPPING

 

All deliverables
required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum,
all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required
materials shall be delivered in immediate usable and acceptable condition.

 

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Contract Number : HHSN272201400039C

 

SECTION E - INSPECTION AND ACCEPTANCE

 

		a.	The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services
to be provided.
	 	 	 
		b.	For the purpose of this SECTION, The Contracting Officer's Representative is the authorized representative
of the Contracting Officer.
	 	 	 
		c.	Inspection and acceptance will be performed at: 

National Institutes of HealthNational Institute of Allergy and Infectious
Diseases 

Division of Microbiology and Infectious Diseases 

5601 Fishers Lane, MSC 9825

Rockville,
MD 20892-9825

	 	 	 

Acceptance may be presumed unless otherwise
indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

 

		d.	This contract incorporates the following clause by reference, with the same force and effect
as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

 

FAR Clause 52.246-3, Inspection of Supplies
- Cost-Reimbursement (May 2001).

 

FAR Clause 52.246-8, Inspection
of Research and Development - Cost-Reimbursement (May 2001).

 

Alternate I (April 1984) is not applicable to this contract.

 

SECTION F - DELIVERIES OR PERFORMANCE

 

ARTICLE
F.1. PERIOD OF PERFORMANCE

		a.	The period of performance of this contract shall be from August 18, 2014 through August 17, 2016.

		b.	If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section
H of this contract, the period of performance will be increased as listed below:

	Option	 	Description
	Option 1	 	Assay Transfer/Qualification
    Phase 2
	Option 2	 	BDS & FDP Technology Transfer
	Option 3	 	Passive Transfer Study (NHP1)
	Option 4	 	Pre-IND meeting and IND Submission
	Option 5	 	Complete Release of BDS, Liquid,
    and Lyophilized Vaccine
	Option 6	 	NHP2 Study
	Option 7	 	Phase 1 Study

 

* Options above are non-severable
and when exercised will extend the period of performance by the time listed in the current Gantt chart.

 

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Contract Number : HHSN272201400039C

 

ARTICLE F.2. DELIVERIES

 

Satisfactory performance of the final
contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this
contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the items listed
therein.

 

a. The items listed in the Statement
of Work shall be addressed and delivered to:

 

	Addressee	 	Deliverable Item No	 	Quantity
	[*****] Contracting Officer's Representative Office of Biodefense Research Affairs (OBRA) Division of Microbiology and Infectious Diseases NIAID, NIH, DHHS 5601 Fishers Lane, [*****] Rockville, MD 20892-9825	 	1 through 27, 34, 35, 36, and 37	 	One (1) Secure Electronic Copy [*****]
	[*****] Contracting Officer Research Contracts Branch - B Office of Acquisitions NIAID, NIH, DHHS 6700B Rockledge Drive, [*****] Bethesda, MD 20892-7612	 	1 through 10, 21, 22, 26, 28, and 29	 	One (1) Secure Electronic Copy [*****]

 

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE,
FAR 52.252-2 (FEBRUARY 1998)

 

This contract incorporates the following clause(s)
by reference, with the same force and effect as if it were given in full text.

 

Upon request, the Contracting
Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:
http://www.acquisition.gov/far.

 

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER
1) CLAUSE: 

 

52.242-15, Stop Work Order (August 1989)

 

Alternate I (April 1984) is applicable
to this contract.

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE
(COR)

 

The following Contracting Officer's Representative
(COR) will represent the Government for the purpose of this contract:

 

[*****]

 

The COR 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.

 

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 for any costs incurred during the performance
of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any
signed agreement shall be incorporated by reference in Section K of the contract

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

 

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Contract Number : HHSN272201400039C

 

The Government may unilaterally change its COR
designation.

 

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70
(January 2006)

 

The key personnel specified in this contract
are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other
programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ
of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion
or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact
on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written
consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the
Contractor or Government.

 

(End of Clause)

 

The following individual(s) is/are considered
to be essential to the work being performed hereunder:

 

	Name	 	Title
	[*****]	 	[*****]
	 	 	 
	[*****]	 	[*****]
	 	 	 
	[*****]	 	[*****]
	 	 	[*****]
	 	 	 
	[*****]	 	[*****]

 

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING
REQUEST AND CONTRACT FINANCIAL REPORT

 

a.   Invoice Submission/Contract
Financing Request and Contract Financial Reporting, NIH(RC)-4for NIH Cost-Reimbursement Type Contracts are attached and made part
of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements
of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

 

1.   Payment requests
shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor
invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

 

		a.	The original invoice shall be submitted to the following designated billing office:

 

National
Institutes of Health

Office
of Financial Management

Commercial
Accounts

2115
East Jefferson Street, Room 4B-432, MSC 8500

Bethesda,
MD 20892-8500

 

	 	b.	One copy of the invoice shall be submitted
    to the approving official via e-mail at:

    NIAIDOAInvoices@niaid.nih.gov

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson.

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Contract Number : HHSN272201400039C

 

	

	 		The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment
request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord,
MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line
of the e-mail shall include the Contractor's name, contract number, and unique invoice number. [Note: The original payment
request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper
invoice."]
	 	 	 
	 	 	The Contractor shall submit an electronic
copy of the payment request to the Central Point of Distribution mailbox. The payment request shall be transmitted as an attachment
via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF).
Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name,
contract number, and unique invoice number. [Note: The original payment request must still be submitted in hard copy and
mailed to the designated billing office to meet the requirements of a "proper invoice."]

 

 2.   In addition to the
requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page
of all payment requests:

 

		a.	Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIAID.
	 	 	 
		b.	Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it
shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's
name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing
contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
	 	 	 
		c.	DUNS or DUNS+4 Number. The DUNS number must identify the
Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the
payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN
is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If
the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
	 	 	 
		d.	Invoice Matching Option. This contract requires a two-way match.
	 	 	 
		e.	Unique Invoice Number. Each payment request must be identified by a unique invoice number, which
can only be used one time regardless of the number of contracts or orders held by an organization.
	 	 	 
		f.	The Contract Title is:

 

Development of Vaccine Formulations
Effective Against NIAID Priority Pathogens

		g.	PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance.

 

b.
 Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

 

c.  The
Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject
to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For billing purposes, certified invoices are
required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing
period utilizing the applicable Fiscal Year funds:

 

"I
hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation
in SECTION I of the above referenced contract."

 

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Contract Number : HHSN272201400039C

 

ARTICLE G.4. INDIRECT COST RATES

 

In accordance with Federal Acquisition Regulation
(FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART
II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost
rates is identified as follows:

 

Director, Division of Financial Advisory
Services

Office of Acquisition Management and Policy

National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA
MD 20892-7663

 

These rates are hereby incorporated without
further action of the Contracting Officer.

 

ARTICLE G.5. GOVERNMENT PROPERTY

 

a.   In
addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall
comply with the provisions of HHS Publication, "HHS Contracting Guide for Contract of Government Property," which is
incorporated into this contract by reference. This document can be accessed at:  http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix
Q_HHS Contracting Guide.pdf.

 

Among other
issues, this publication provides a summary of the Contractor's responsibilities regarding purchasing authorizations and inventory
and reporting requirements under the contract.

 

Requests for
information regarding property under this contract should be directed to the following office:

 

Division
of Logistics Services, NIH

Property
Management Branch 6011

Building,
Suite 639 6011

EXECUTIVE
BLVD MSC 7670

BETHESDA
MD 20892-7670

nihcontractproperty@nih.gov

 

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR
PERFORMANCE

 

	a.	Contractor Performance Evaluations

 

Interim
and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final
performance evaluation will be prepared at the time of completion of work.

 

Interim and Final evaluations will
be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty
days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between
the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

 

Copies
of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may
be used to support future award decisions.

 

	b.	Electronic Access to Contractor Performance Evaluations

 

Contractors
may access evaluations through a secure Web site for review and comment at the following address: http://www.cpars.gov

 

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Contract Number : HHSN272201400039C

 

SECTION
H - SPECIAL CONTRACT REQUIREMENTS

 

ARTICLE
H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

 

		a.	The
                                                              Contractor agrees that the rights and welfare of human subjects
                                                              involved in research under this contract shall be protected in accordance
                                                              with 45 CFR Part 46 and with the Contractor's current Assurance
                                                              of Compliance on file with the Office for Human Research Protections
                                                              (OHRP), Department of Health and Human Services. The Contractor
                                                              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
                                                              Contractor shall bear full responsibility for the performance of
                                                              all work and services involving the use of human subjects under
                                                              this contract and shall ensure that work is conducted in a proper
                                                              manner and as safely as is feasible. The parties hereto agree that
                                                              the Contractor retains the right to control and direct the performance
                                                              of all work under this contract. The Contractor shall not deem anything
                                                              in this contract to constitute the Contractor or any subcontractor,
                                                              agent or employee of the Contractor, or any other person, organization,
                                                              institution, or group of any kind whatsoever, as the agent or employee
                                                              of the Government. The Contractor 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 contractor without imputing liability
                                                              on the part of the Government for the acts of the Contractor or
                                                              its employees.

 

		c.	If
                                                              at any time during the performance of this contract, the Contracting
                                                              Officer determines, in consultation with OHRP that the Contractor
                                                              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 Contractor corrects the noncompliance.
                                                              The Contracting Officer may communicate the notice of suspension
                                                              by telephone with confirmation in writing. If the Contractor fails
                                                              to complete corrective action within the period of time designated
                                                              in the Contracting Officer's written notice of suspension, the Contracting
                                                              Officer may, after consultation with OHRP, terminate this contract
                                                              in whole or in part, and the Contractor's name may be removed from
                                                              the list of those contractors with approved Human Subject Assurances.

 

(End
of clause)

 

ARTICLE
H.2. HUMAN SUBJECTS

 

Research
involving human subjects shall not be conducted under this contract until the protocol developed in Phase I has been approved
by NIAID, written notice of such approval has been provided by the Contracting Officer, and the Contractor has provided to the
Contracting Officer a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration
of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the protocol. The
human subject certification can be met by submission of the Contractor's self designated form, provided that it contains
the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption",
Form OMB No. 0990-0263 (formerly Optional Form 310).

 

When
research involving Human Subjects will take place at collaborating sites or other performance sites, the Contractor shall obtain,
and keep on file, a properly completed "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration
of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and approval of the research.

 

ARTICLE
H.3. RESTRICTION ON USE OF HUMAN SUBJECTS, HHSAR 352.270-6 (January 2006)

 

Pursuant
to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research
involving human subjects or engage in any human subjects research activity prior to the
Contracting Officer's receipt of a certification that the research has been reviewed and approved by the Institutional Review
Board (IRB) designated under the Contractor's Federal-wide assurance of compliance. This restriction applies to all collaborating
sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors.

 

(End
of clause)

 

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Contract Number : HHSN272201400039C

 

Prisoners
shall not be enrolled in any HHS research activities until all requirements of HHS Regulations at 45 CFR PART 46, Subpart C have
been met. If a Research Subject becomes a prisoner during the period of this contract, 45 CFR PART 46, Subpart C will apply to
research involving that individual.

 

ARTICLE
H.4. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

 

NIH
policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards
for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the
protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement
dated June 5, 2000 at the following website:

 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

 

The information below is a summary of the
NIH Policy Announcement:

 

The
Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any
other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title
of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one
sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals
responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

 

Prior
to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research
under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the
education program and a one sentence description of the program that has been completed by the replacement.

 

ARTICLE
H.5. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

 

The
Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events,
which may be found at the following web sites:

 

http://grants.nih.gov/grants/guide/notice-files/not98-084.html

http://grants.nih.gov/grants/guide/notice-files/not99-107.html

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

 

The
Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements
found elsewhere in this contract.

 

Data
and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan.

 

The
Data and Safety Monitoring Board shall be established and approved prior to beginning the conduct of the clinical trial.

 

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Contract Number : HHSN272201400039C

 

ARTICLE
H.6. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV

 

The
Food and Drug Administration Amendments Act of 2007 (FDAAA) at: http://frwebgate.access.gpo.gov/cgi-bin/
getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf, Title VIII, expands the National Institutes ofHealth's
(NIH's) clinical trials registry and results database known as ClinicalTrials.gov and imposes
new requirements that apply to specified "applicable clinical trials," including those supported in whole or in part
by NIH funds. FDAAA requires:

 

		●	the
registration of certain "applicable clinical trials" (see Definitions at: http://grants.nih.gov/ClinicalTrials_fdaaa/ definitions.htm) in ClinicalTrials.gov no later than 21 days after
the first subject is enrolled; and

 

		●	the
                                                                                                                                                       reporting
                                                                                                                                                       of
                                                                                                                                                       summary
                                                                                                                                                       results
                                                                                                                                                       information
                                                                                                                                                       (including
                                                                                                                                                       adverse
                                                                                                                                                       events)
                                                                                                                                                       no
                                                                                                                                                       later
                                                                                                                                                       than
                                                                                                                                                       1
                                                                                                                                                       year
                                                                                                                                                       after
                                                                                                                                                       the
                                                                                                                                                       completion
                                                                                                                                                       date
                                                                                                                                                       (See
                                                                                                                                                       Definitions
                                                                                                                                                       at
                                                                                                                                                       link
                                                                                                                                                       above)
                                                                                                                                                       for
                                                                                                                                                       registered
                                                                                                                                                       applicable
                                                                                                                                                       clinical
                                                                                                                                                       trials
                                                                                                                                                       involving
                                                                                                                                                       drugs
                                                                                                                                                       that
                                                                                                                                                       are
                                                                                                                                                       approved
                                                                                                                                                       under
                                                                                                                                                       section
                                                                                                                                                       505
                                                                                                                                                       of
                                                                                                                                                       the
                                                                                                                                                       Food,
                                                                                                                                                       Drug
                                                                                                                                                       and
                                                                                                                                                       Cosmetic
                                                                                                                                                       Act
                                                                                                                                                       (FDCA)
                                                                                                                                                       or
                                                                                                                                                       licensed
                                                                                                                                                       under
                                                                                                                                                       section
                                                                                                                                                       351
                                                                                                                                                       of
                                                                                                                                                       the
                                                                                                                                                       PHS
                                                                                                                                                       Act,
                                                                                                                                                       biologics,
                                                                                                                                                       or
                                                                                                                                                       of
                                                                                                                                                       devices
                                                                                                                                                       that
                                                                                                                                                       are
                                                                                                                                                       cleared
                                                                                                                                                       under
                                                                                                                                                       section
                                                                                                                                                       510k
                                                                                                                                                       of
                                                                                                                                                       FDCA.

 

In
addition, the Contractor shall notify the Contracting Officer's Representative (COR), with the trial registration number (NCT
number), once the registration is accomplished. This notification may be included in the Technical Progress Report covering the
period in which registration occurred, or as a stand alone notification.

 

The
IND Sponsor will be determined after contract award, which will be the "Responsible Party" for the purposes of compliance
with FDAAA which includes registration (and results reporting, if required) of applicable clinical trial(s) performed under this
contract in the Government database, ClinicalTrials.gov (http://www.ClinicalTrials.gov
).

 

Additional
information is available at: http://prsinfo.clinicaltrials.gov .

 

ARTICLE
H.7. HUMAN MATERIALS

 

The
acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by
the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in
the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation
of human material.

 

ARTICLE
H.8. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

 

The
acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by
the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in
the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation
of human material.

 

The
Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects
conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with
prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46
to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether
domestic or foreign, and compliance must be ensured by the Contractor.

 

Provision
by the Contractor to the Contracting Officer of a properly completed "Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval
of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject
certification can be met by submission of a self designated form, provided that it contains the information required by the "Protection
of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly Optional
Form 310).

 

ARTICLE
H.9. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES (Including Human Gene Transfer Research)

 

All
research projects (both NIH-funded and non-NIH-funded) involving recombinant or synthetic nucleic acid molecules that are conducted
at or sponsored by an entity in the U.S. that receives any support for recombinant or synthetic nucleic acid research from NIH
shall be conducted in accordance with the NIH Guidelines for Research
Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) available at: http://oba.od.nih.gov/rdna/
nih_guidelines_oba.html). All NIH-funded projects abroad that include recombinant or synthetic nucleic acid molecules
must also comply with the NIH Guidelines.

 

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Contract Number : HHSN272201400039C

 
 The
                                                                                    NIH Guidelines stipulate biosafety and containment
                                                                                    measures for recombinant or synthetic nucleic
                                                                                    acid research, which is defined in the NIH
                                                                                    Guidelines as research with (1) molecules
                                                                                    that a) are constructed by joining nucleic
                                                                                    acid molecules and b) can replicate in a living
                                                                                    cell, i.e. recombinant nucleic acids, or (2)
                                                                                    nucleic acid molecules that are chemically
                                                                                    or by other means synthesized or amplified,
                                                                                    including those that are chemically or otherwise
                                                                                    modified but can base pair with naturally
                                                                                    occurring nucleic acid molecules, i.e. synthetic
                                                                                    nucleic acids, or (3) molecules that result
                                                                                    from the replication of those described in
                                                                                    (1) or (2). The NIH Guidelines apply to both
                                                                                    basic and clinical research. Specific guidance
                                                                                    for the conduct of human gene transfer studies
                                                                                    appears in Appendix M of the NIH Guidelines.

 

Failure
to comply with the NIH Guidelines may result in suspension, limitation, or termination of the contract for any work related
to recombinant or synthetic nucleic acid research or a requirement for the Contracting Officer to approve any or all recombinant
or synthetic nucleic acid molecule projects under this contract. This includes the requirement for the institution to have an
Institutional Biosafety Committee (IBC) registered with NIH OBA that complies with the requirements of the NIH Guidelines. Further
information about compliance with the NIH Guidelines can be found on the NIH Office of Biotechnology Activities (OBA) website
available at: http://oba.od.nih.gov/rdna_ibc/ibc.html.

 

ARTICLE
H.10. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

 

NIH-funded
investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's
final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from
NIH. NIH defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health
care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

 

Additional
information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html.

 

ARTICLE
H.11. NEEDLE DISTRIBUTION

 

The
Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic
injection of any illegal drug.

 

ARTICLE
H.12. ACKNOWLEDGEMENT OF FEDERAL FUNDING

 

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: (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.13. RESTRICTION ON ABORTIONS

 

The
Contractor shall not use contract funds for any abortion.

 

ARTICLE
H.14. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

 

The
Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research
in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that
allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)). The term "human embryo or embryos" includes any organism, not
protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis,
cloning, or any other means from one or more human gametes or human diploid cells.

 

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Contract Number : HHSN272201400039C
  

Additionally,
in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

 

ARTICLE
H.15. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

 

The
Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

 

ARTICLE
H.16. PRIVACY ACT, HHSAR 352.224-70 (January 2006)

 

This
contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop; or (c) operate a Federal agency
system of records to accomplish an agency function in accordance with the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and
applicable agency regulations. The term "system of records" means a group of any records under the control of any agency
from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying
particular assigned to the individual. Violations of the Act by the Contractor and/or its employees may result in the imposition
of criminal penalties (5 U.S.C. 552a(i)). The Contractor shall ensure that each of its employees knows the prescribed rules of
conduct and that each employee is aware that he/she is subject to criminal penalties for violation of the Act to the same extent
as Department of Health and Human Services employees. These provisions also apply to all subcontracts the Contractor awards under
this contract which require the design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)].
The contract work statement: (a) identifies the system(s) of records and the design, development, or operation work the Contractor
is to perform; and (b) specifies the disposition to be made of such records upon completion of contract performance.

 

(End
of clause)

 

45
CFR Part 5b contains additional information which includes the rules of conduct and other Privacy Act requirements and can be
found at: http://www.access.gpo.gov/nara/cfr/waisidx_06/45cfr5b_06.html.

 

The
Privacy Act System of Records applicable to this project is Number 09-25-0200. This document is incorporated into this contract
as an Attachment in SECTION J of this contract. This document is also available at: http://
oma.od.nih.gov/public/MS/privacy/PAfiles/read02systems.htm.

 

ARTICLE
H.17. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

 

		a.	Before
                                                                                                         undertaking performance
                                                                                                         of any contract involving
                                                                                                         animal-related activities
                                                                                                         where the species is
                                                                                                         regulated by USDA, the
                                                                                                         Contractor shall register
                                                                                                         with the Secretary of
                                                                                                         Agriculture of the United
                                                                                                         States in accordance
                                                                                                         with 7 U.S.C. 2136 and
                                                                                                         9 CFR sections 2.25 through
                                                                                                         2.28. The Contractor
                                                                                                         shall furnish evidence
                                                                                                         of the registration to
                                                                                                         the Contracting Officer.

 

		b.	The
                                                                                                         Contractor shall acquire
                                                                                                         vertebrate animals used
                                                                                                         in research from a dealer
                                                                                                         licensed by the Secretary
                                                                                                         of Agriculture under
                                                                                                         7 U.S.C. 2133 and 9 CFR
                                                                                                         Sections 2.1-2.11, or
                                                                                                         from a source that is
                                                                                                         exempt from licensing
                                                                                                         under those sections.

 

		c.	The
                                                                                                         Contractor agrees that
                                                                                                         the care, use and intended
                                                                                                         use of any live vertebrate
                                                                                                         animals in the performance
                                                                                                         of this contract shall
                                                                                                         conform with the Public
                                                                                                         Health Service (PHS)
                                                                                                         Policy on Humane Care
                                                                                                         of Use of Laboratory
                                                                                                         Animals (PHS Policy),
                                                                                                         the current Animal Welfare
                                                                                                         Assurance (Assurance),
                                                                                                         the Guide for the Care
                                                                                                         and Use of Laboratory
                                                                                                         Animals (National Academy
                                                                                                         Press, Washington, DC)
                                                                                                         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
                                                                                                         1-4). In case of conflict
                                                                                                         between standards, the
                                                                                                         more stringent standard
                                                                                                         shall govern.

 

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	 	d.	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 Contractor is not in compliance with any of the requirements and standards
    stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and
    further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated
    by telephone and confirmed in writing. If the Contractor 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 Contractor's name may be removed from the list of those contractors with approved
    Assurances.
	 	 	 
	 	 	Note: The Contractor
    may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal
    and Plant Health Inspection Service (APHIS), USDA, for the region 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 the
    Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (E-mail:
    ace@aphis.usda.gov; Web site: ( http://www.aphis.usda.gov/ animal_welfare).

 

(End
of Clause)

 

ARTICLE
H.18. ANIMAL WELFARE

 

All
research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care
and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at:

 

http://
grants1.nih.gov/grants/olaw/references/phspol.htm

 

In
addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the
Vertebrate Animal Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated
August 5, 2014, which is incorporated by reference.

 

ARTICLE
H.19. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

 

All
Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the
procedures set forth in NIH Policy Manual 3044-2, entitled, "Protection of NIH Personnel Who Work with Nonhuman Primates,"
located at the following URL:

 

http://oma.od1.nih.gov/manualchapters/intramural/3044-2/

 

ARTICLE H.20. OMB CLEARANCE

 

In
accordance with HHSAR 352.201-70, Paperwork Reduction Act, the Contractor shall not proceed with surveys or interviews until such
time as Office of Management and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer's
Representative (COR) and the Contracting Officer has issued written approval to proceed.

 

ARTICLE
H.21. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS OMB CLEARANCE

 

The
Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading,
and exchanging of pornography.

 

ARTICLE
H.22. GUN CONTROL OMB CLEARANCE

 

The
Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

 

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Contract Number : HHSN272201400039C

 

ARTICLE
H.23. CERTIFICATION OF FILING AND PAYMENT OF TAXES OMB CLEARANCE

 

The
contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

 

ARTICLE
H.24. OPTION PROVISION

 

Unless
the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the
Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-7, Option for
Increased Quantity-Separately Priced Line Item set forth in SECTION I. of this contract, the Government may, by unilateral contract
modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections
C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration
date of this contract, and the estimated cost plus fixed fee of the contract will be increased as set forth in the ESTIMATED COST
PLUS FIXED FEE Article in SECTION B of this contract.

 

ARTICLE
H.25. INFORMATION AND PHYSICAL ACCESS SECURITY

 

A.
Security Requirements For Federal Information Technology Resources, HHSAR 352.239-72, (January 2010)

 

a.
  Applicability. This clause applies whether the entire contract or order (hereafter "contract"), or portion
thereof, includes information technology resources or services in which the Contractor has physical or logical (electronic) access
to, or operates a Department of Health and Human Services (HHS) system containing, information that directly supports HHS' mission.
The term "information technology (IT)", as used in this clause, includes computers, ancillary equipment (including imaging
peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be
controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support
services) and related resources. This clause does not apply to national security systems as defined in FISMA.

 

b.
  Contractor responsibilities. The Contractor is responsible for the following:

 

1.
 Protecting Federal information and Federal information systems in order to ensure their -

 

		a.	Integrity,
                                                                                                        which means guarding against
                                                                                                        improper information modification
                                                                                                        or destruction, and includes
                                                                                                        ensuring information non-repudiation
                                                                                                        and authenticity;

 

		b.	Confidentiality,
                                                                                                        which means preserving
                                                                                                        authorized restrictions
                                                                                                        on access and disclosure,
                                                                                                        including means for protecting
                                                                                                        personal privacy and proprietary
                                                                                                        information; and

 

		c.	Availability,
                                                                                                        which means ensuring timely
                                                                                                        and reliable access to
                                                                                                        and use of information.

 

2.
  Providing security of any Contractor systems, and information contained therein, connected to an HHS network or operated by the
Contractor, regardless of location, on behalf of HHS.

 

3.
  Adopting, and implementing, at a minimum, the policies, procedures, controls and standards of the HHS Information Security Program
to ensure the integrity, confidentiality, and availability of Federal information and Federal information systems for which the
Contractor is responsible under this contract or to which it may otherwise have access under this contract. The HHS Information
Security Program is outlined in the HHS Information Security Program Policy, which is available on the HHS Office of the Chief
Information Officer's (OCIO) Web site.

 

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Contract Number : HHSN272201400039C

 

c. 
 Contractor security deliverables. In accordance with the timeframes specified, the Contractor shall prepare and submit
the following security documents to the Contracting Officer for review, comment, and acceptance:

 

1.
IT Security Plan (IT-SP) - due within 30 days after the project kickoff meeting. The IT-SP shall be consistent with, and
further detail the approach to, IT security contained in the Contractor's bid or proposal
that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow
to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies
to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

 

		a.	The
                                                                                                        Contractor's IT-SP shall
                                                                                                        comply with applicable
                                                                                                        Federal laws that include,
                                                                                                        but are not limited to,
                                                                                                        the Federal Information
                                                                                                        Security Management Act
                                                                                                        (FISMA) of 2002 (Title
                                                                                                        III of the E-Government
                                                                                                        Act of 2002, Public Law
                                                                                                        107-347), and the following
                                                                                                        Federal and HHS policies
                                                                                                        and procedures:

 

		i.	Office
                                                                                                      of Management and Budget
                                                                                                      (OMB) Circular A-130, Management
                                                                                                      of Federal Information Resources,
                                                                                                      Appendix III, Security of
                                                                                                      Federal Automation Information
                                                                                                      Resources.

 

		ii.	National
                                                                                                       Institutes of Standards
                                                                                                       and Technology (NIST) Special
                                                                                                       Publication (SP) 800-18,
                                                                                                       Guide for Developing Security
                                                                                                       Plans for Information Systems,
                                                                                                       in form and content, and
                                                                                                       with any pertinent contract
                                                                                                       Statement of Work/Performance
                                                                                                       Work Statement (SOW/ PWS)
                                                                                                       requirements. The IT-SP
                                                                                                       shall identify and document
                                                                                                       appropriate IT security
                                                                                                       controls consistent with
                                                                                                       the sensitivity of the
                                                                                                       information and the requirements
                                                                                                       of Federal Information
                                                                                                       Processing Standard (FIPS)
                                                                                                       200, Recommend Security
                                                                                                       Controls for Federal Information
                                                                                                       Systems. The Contractor
                                                                                                       shall review and update
                                                                                                       the IT-SP in accordance
                                                                                                       with NIST SP 800-26, Security
                                                                                                       Self-Assessment Guide for
                                                                                                       Information Technology
                                                                                                       Systems and FIPS 200, on
                                                                                                       an annual basis.

 

		iii.	HHS-OCIO
                                                                                                        Information Systems Security
                                                                                                        and Privacy Policy.

 

		2.	IT
                                                                                                               Risk Assessment
                                                                                                               (IT-RA) - due
                                                                                                               within 30 days
                                                                                                               after the project
                                                                                                               kickoff meeting.
                                                                                                               The IT-RA shall
                                                                                                               be consistent,
                                                                                                               in form and content,
                                                                                                               with NIST SP 800-30,
                                                                                                               Risk Management
                                                                                                               Guide for Information
                                                                                                               Technology Systems,
                                                                                                               and any additions
                                                                                                               or augmentations
                                                                                                               described in the
                                                                                                               HHS-OCIO Information
                                                                                                               Systems Security
                                                                                                               and Privacy Policy.
                                                                                                               After resolution
                                                                                                               of any comments
                                                                                                               provided by the
                                                                                                               Government on the
                                                                                                               draft IT-RA, the
                                                                                                               Contracting Officer
                                                                                                               shall accept the
                                                                                                               IT-RA and incorporate
                                                                                                               the Contractor's
                                                                                                               final version into
                                                                                                               the contract for
                                                                                                               Contractor implementation
                                                                                                               and maintenance.
                                                                                                               The Contractor
                                                                                                               shall update the
                                                                                                               IT-RA on an annual
                                                                                                               basis.

 

		3.	FIPS
                                                                                                               199 Standards for
                                                                                                               Security Categorization
                                                                                                               of Federal Information
                                                                                                               and Information
                                                                                                               Systems Assessment
                                                                                                               (FIPS 199 Assessment)
                                                                                                               - due within
                                                                                                               30 days after the
                                                                                                               project kickoff
                                                                                                               meeting. The FIPS
                                                                                                               199 Assessment
                                                                                                               shall be consistent
                                                                                                               with the cited
                                                                                                               NIST standard.
                                                                                                               After resolution
                                                                                                               of any comments
                                                                                                               by the Government
                                                                                                               on the draft FIPS
                                                                                                               199 Assessment,
                                                                                                               the Contracting
                                                                                                               Officer shall accept
                                                                                                               the FIPS 199 Assessment
                                                                                                               and incorporate
                                                                                                               the Contractor's
                                                                                                               final version into
                                                                                                               the contract.

 

		4.	IT
                                                                                                               Security Certification
                                                                                                               and Accreditation
                                                                                                               (IT-SC&A) -
                                                                                                               due within 3 months
                                                                                                               after contract
                                                                                                               award. The Contractor
                                                                                                               shall submit written
                                                                                                               proof to the Contracting
                                                                                                               Officer that an
                                                                                                               IT-SC&A was
                                                                                                               performed for applicable
                                                                                                               information systems
                                                                                                               - see paragraph
                                                                                                               (a) of this clause.
                                                                                                               The Contractor
                                                                                                               shall perform the
                                                                                                               IT-SC&A in
                                                                                                               accordance with
                                                                                                               the HHS Chief Information
                                                                                                               Security Officer's
                                                                                                               Certification and
                                                                                                               Accreditation Checklist;
                                                                                                               NIST SP 800-37,
                                                                                                               Guide for the Security,
                                                                                                               Certification and
                                                                                                               Accreditation of
                                                                                                               Federal Information
                                                                                                               Systems; and NIST
                                                                                                               800-53, Recommended
                                                                                                               Security Controls
                                                                                                               for Federal Information
                                                                                                               Systems. An authorized
                                                                                                               senior management
                                                                                                               official shall
                                                                                                               sign the draft
                                                                                                               IT-SC&A and
                                                                                                               provided it to
                                                                                                               the Contracting
                                                                                                               Officer for review,
                                                                                                               comment, and acceptance.

 

		a.	After
                                                                                                        resolution of any comments
                                                                                                        provided by the Government
                                                                                                        on the draft IT SC&A,
                                                                                                        the Contracting Officer
                                                                                                        shall accept the IT-SC&A
                                                                                                        and incorporate the Contractor's
                                                                                                        final version into the
                                                                                                        contract as a compliance
                                                                                                        requirement.

 

		b.	The
                                                                                                        Contractor shall also
                                                                                                        perform an annual security
                                                                                                        control assessment and
                                                                                                        provide to the Contracting
                                                                                                        Officer verification that
                                                                                                        the IT-SC&A remains
                                                                                                        valid. Evidence of a valid
                                                                                                        system accreditation includes
                                                                                                        written results of:

 

		i.	Annual
                                                                                                                                                   testing
                                                                                                                                                   of
                                                                                                                                                   the
                                                                                                                                                   system
                                                                                                                                                   contingency
                                                                                                                                                   plan;
                                                                                                                                                   and

 

		ii.	The
                                                                                                                                                    performance
                                                                                                                                                    of
                                                                                                                                                    security
                                                                                                                                                    control
                                                                                                                                                    testing
                                                                                                                                                    and
                                                                                                                                                    evaluation.

 

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Contract Number : HHSN272201400039C

 

d.
  Personal identity verification. The Contractor shall identify its employees with access to systems operated by the Contractor
for HHS or connected to HHS systems and networks. The Contracting Officer's Representative (COR) shall identify, for those identified
employees, position sensitivity levels that are commensurate with the responsibilities and risks associated with their assigned
positions. The Contractor shall comply with the HSPD-12 requirements contained in "HHS-Controlled Facilities and Information
Systems Security" requirements specified in the SOW/PWS of this contract.

 

e.
  Contractor and subcontractor employee training. The Contractor shall ensure that its employees, and those of its subcontractors,
performing under this contract complete HHS-furnished initial and refresher security and privacy education and awareness training
before being granted access to systems operated by the Contractor on behalf of HHS or access to HHS systems and networks. The
Contractor shall provide documentation to the COR evidencing that Contractor employees have completed the required training.

 

f.
  Government access for IT inspection. The Contractor shall afford the Government access to the Contractor's and subcontractors'
facilities, installations, operations, documentation, databases, and personnel used in performance of this contract to the extent
required to carry out a program of IT inspection (to include vulnerability testing), investigation, and audit to safeguard against
threats and hazards to the integrity, confidentiality, and availability, of HHS data or to the protection of information systems
operated on behalf of HHS.

 

g.
  Subcontracts. The Contractor shall incorporate the substance of this clause in all subcontracts that require protection
of Federal information and Federal information systems as described in paragraph (a) of this clause, including those subcontracts
that -

 

		a.	Have
                                                                                                        physical or electronic
                                                                                                        access to HHS' computer
                                                                                                        systems, networks, or
                                                                                                        IT infrastructure; or

 

		b.	Use
                                                                                                        information systems to
                                                                                                        generate, store, process,
                                                                                                        or exchange data with
                                                                                                        HHS or on behalf of HHS,
                                                                                                        regardless of whether
                                                                                                        the data resides on a
                                                                                                        HHS or the Contractor's
                                                                                                        information system.

 

h.
  Contractor employment notice. The Contractor shall immediately notify the Contracting Officer when an employee either begins
or terminates employment (or is no longer assigned to the HHS project under this contract), if that employee has, or had, access
to HHS information systems or data.

 

i.
   Document information. The Contractor shall contact the Contracting Officer for any documents, information, or forms necessary
to comply with the requirements of this clause.

 

j.
  Contractor responsibilities upon physical completion of the contract. The Contractor shall return all HHS information and
IT resources provided to the Contractor during contract performance and certify that all HHS information has been purged from
Contractor-owned systems used in contract performance.

 

k.
  Failure to comply. Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause
shall be grounds for the Contracting Officer to terminate this contract.

 

(End
of Clause)

 

Note:
The NIST Special Publication SP-800-26 cited in subparagraph c.1.a.(ii) of this clause has been superseded by NIST SP 800-53A,
"Guide for Assessing the Security Controls in Federal Information Systems and Organizations" for use for the assessment
of security control effectiveness. See http://csrc.nist.gov/ publications/PubsSPs.html to access NIST Special Publications
(800 Series).

 

B.
Additional NIH Requirements

 

1.
  SECURITY CATEGORIZATION OF FEDERAL INFORMATION AND INFORMATION SYSTEMS (FIPS 199 Assessment)

 

a.
Information Type:

 

£
Administrative, Management and Support Information:

 

S
Mission Based Information:

  

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Contract Number : HHSN272201400039C

 

		b.	Security
                                                                                                                                                      Categories
                                                                                                                                                      and
                                                                                                                                                      Levels:
	 	 	 

	Confidentiality
    Level:	S
    Low	£
    Moderate	£
    High
	Integrity Level:	£ Low	S
    Moderate	£ High
	Availability
    Level:	S Low	£
    Moderate	£ High
	Overall Level:	£ Low	S Moderate	£ High

 

		c.	In
                                                                                                                                                      accordance
                                                                                                                                                      with
                                                                                                                                                      HHSAR
                                                                                                                                                      Clause
                                                                                                                                                      352.239-72,
                                                                                                                                                      the
                                                                                                                                                      contractor
                                                                                                                                                      shall
                                                                                                                                                      submit
                                                                                                                                                      a
                                                                                                                                                      FIPS
                                                                                                                                                      199
                                                                                                                                                      Assessment
                                                                                                                                                      within
                                                                                                                                                      30
                                                                                                                                                      days
                                                                                                                                                      after
                                                                                                                                                      contract
                                                                                                                                                      award.
                                                                                                                                                      Any
                                                                                                                                                      differences
                                                                                                                                                      between
                                                                                                                                                      the
                                                                                                                                                      contractor's
                                                                                                                                                      assessment
                                                                                                                                                      and
                                                                                                                                                      the
                                                                                                                                                      information
                                                                                                                                                      contained
                                                                                                                                                      herein,
                                                                                                                                                      will
                                                                                                                                                      be
                                                                                                                                                      resolved,
                                                                                                                                                      and
                                                                                                                                                      if
                                                                                                                                                      required,
                                                                                                                                                      the
                                                                                                                                                      contract
                                                                                                                                                      will
                                                                                                                                                      be
                                                                                                                                                      modified
                                                                                                                                                      to
                                                                                                                                                      incorporate
                                                                                                                                                      the
                                                                                                                                                      final
                                                                                                                                                      FIPS
                                                                                                                                                      199
                                                                                                                                                      Assessment.

 

2.
  INFORMATION SECURITY TRAINING

 

In
addition to any training covered under paragraph (e) of HHSAR 352.239-72, the contractor shall comply with the below training:

 

a.
  Mandatory Training

 

		i.	All
                                                                                                         Contractor employees
                                                                                                         having access to (1)
                                                                                                         Federal information or
                                                                                                         a Federal information
                                                                                                         system or (2) sensitive
                                                                                                         data/information as defined
                                                                                                         at HHSAR 304.1300(a)
                                                                                                         (4), shall complete the
                                                                                                         NIH Computer Security
                                                                                                         Awareness Training course
                                                                                                         at http:// irtsectraining.nih.gov/
                                                                                                         before performing
                                                                                                         any work under this contract.
                                                                                                         Thereafter, Contractor
                                                                                                         employees having access
                                                                                                         to the information identified
                                                                                                         above shall complete
                                                                                                         an annual NIH-specified
                                                                                                         refresher course during
                                                                                                         the life of this contract.
                                                                                                         The Contractor shall
                                                                                                         also ensure subcontractor
                                                                                                         compliance with this
                                                                                                         training requirement.

 

		ii.	The
                                                                                                          Contractor shall maintain
                                                                                                          a listing by name and
                                                                                                          title of each Contractor/Subcontractor
                                                                                                          employee working on
                                                                                                          this contract and having
                                                                                                          access of the kind in
                                                                                                          paragraph 1.a(1) above,
                                                                                                          who has completed the
                                                                                                          NIH required training.
                                                                                                          Any additional security
                                                                                                          training completed by
                                                                                                          the Contractor/Subcontractor
                                                                                                          staff shall be included
                                                                                                          on this listing. The
                                                                                                          list shall be provided
                                                                                                          to the COR and/or Contracting
                                                                                                          Officer upon request.

 

b.
  Role-based Training

 

HHS
requires role-based training when responsibilities associated with a given role or position, could, upon execution, have the potential
to adversely impact the security posture of one or more HHS systems. Read further guidance about "NIH Information Security
Awareness and Training Policy," at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/Final-InfoSecAwarenessTrainPol.doc.

 

The
Contractor shall maintain a list of all information security training completed by each contractor/subcontractor employee working
under this contract. The list shall be provided to the COR and/or Contracting Officer upon request.

 

c.
  Rules of Behavior

 

The
Contractor shall ensure that all employees, including subcontractor employees, comply with the NIH Information Technology General
Rules of Behavior (https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx),
which are contained in the NIH Information Security Awareness Training Course http://irtsectraining.nih.gov.

 

 

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Contract Number : HHSN272201400039C

 

3.
PERSONNEL SECURITY RESPONSIBILITIES

 

In
addition to any personnel security responsibilities covered under HHSAR 352.239-72, the contractor shall comply with the below
personnel security responsibilities:

 

		a.	In
                                         accordance with Paragraph (h) of HHSAR 352.239-72, the Contractor shall notify the Contracting
                                         officer and the COR within five working days before a new employee assumes a position
                                         that requires access to HHS information systems or data, or when an employee with such
                                         access stops working on this contract. The Government will initiate a background investigation
                                         on new employees assuming a position that requires access to HHS information systems
                                         or data, and will stop pending background investigations for employees that no longer
                                         work under the contract or no longer have such access.
	 	 	 
		b.	New
                                         contractor employees who have or will have access to HHS information systems or data:
                                         The Contractor shall provide the COR with the name, position title, e-mail address,
                                         and phone number of all new contract employees working under the contract and provide
                                         the name, position title and position sensitivity level held by the former incumbent.
                                         If an employee is filling a new position, the Contractor shall provide a position description
                                         and the Government will determine the appropriate position sensitivity level.
	 	 	 
		c.	Departing
                                         contractor employees: The Contractor shall provide the COR with the name, position
                                         title, and position sensitivity level held by or pending for departing employees. The
                                         Contractor shall perform and document the actions identified in the Contractor Employee
                                         Separation Checklist ( https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf)
                                         when a Contractor/subcontractor employee terminates work under this contract. All documentation
                                         shall be made available to the COR upon request.
	 	 	 
		d.	Commitment
                                         to Protect Non-Public Departmental Information and Data.
	 	 	 
	 	 	The
                                         Contractor, and any subcontractors performing under this contract, shall not release,
                                         publish, or disclose non-public Departmental information to unauthorized personnel, and
                                         shall protect such information in accordance with provisions of the following laws and
                                         any other pertinent laws and regulations governing the confidentiality of such information:
	 	 	 
	 	 	-
                                         18 U.S.C. 641 (Criminal Code: Public Money, Property or Records)

-
18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)

- Public Law 96-511 (Paperwork Reduction Act)

 
	 	 	Each
                                         employee, including subcontractors, having access to non-public Department information
                                         under this acquisition shall complete the "Commitment to Protect Non-Public Information
                                         - Contractor Employee Agreement" located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf.
                                         A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to
                                         the Project Officer/COR prior to performing any work under this acquisition.

 

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Contract
Number : HHSN272201400039C

 

4.
LOSS AND/OR DISCLOSURE OF PERSONALLY IDENTIFIABLE INFORMATION (PII) - NOTIFICATION OF DATA BREACH

 

The
Contractor shall report all suspected or confirmed incidents involving the loss and/or disclosure of PII in electronic or physical
form. Notification shall be made to the NIH Incident Response Team (IRT) via email ( IRT@mail.nih.gov)
within one hour* of discovering the incident. The Contractor shall follow up with IRT by completing and submitting one of
the applicable two forms below within three (3) work days of incident discovery:

 

NIH
PII Spillage Report at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/

NIH
PII Spillage Proced.doc 

NIH
Lost or Stolen Assets Report at: https://ocio.nih.gov/InfoSecurity/Policy/Documents/ ISSO_Stolen_Device-Media_Handling_Procedures.doc

 

*
Soligenix will make reasonable efforts to notify NIAID as soon as possible.

 

ARTICLE
H.26. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010)

 

		a.	Pursuant
                                         to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the
                                         Workforce Investment Act of 1998, all electronic and information technology (EIT) products
                                         and services developed, acquired, maintained, or used under this contract/order must
                                         comply with the "Electronic and Information Technology Accessibility Provisions"
                                         set forth by the Architectural and Transportation Barriers Compliance Board (also referred
                                         to as the "Access Board") in 36 CFR part 1194. Information about Section 508
                                         provisions is available at http://www.section508.gov/. The complete text of Section
                                         508 Final provisions can be accessed at http://www.access-board.gov/guidelines-and-standards.

 

		b.	The
                                         Section 508 standards applicable to this contract/order are identified in the Statement
                                         of Work. The contractor must provide a written Section 508 conformance certification
                                         due at the end of each contract/ order exceeding $100,000 when the contract/order duration
                                         is one year or less. If it is determined by the Government that EIT products and services
                                         provided by the Contractor do not conform to the described accessibility standards in
                                         the Product Assessment Template, remediation of the products or services to the level
                                         of conformance specified in the Contractor's Product Assessment Template will be the
                                         responsibility of the Contractor at its own expense.

 

		c.	In
                                         the event of a modification(s) to this contract/order, which adds new EIT products or
                                         services or revises the type of, or specifications for, products or services the Contractor
                                         is to provide, including EIT deliverables such as electronic documents and reports, the
                                         Contracting Officer may require that the contractor submit a completed HHS Section 508
                                         Product Assessment Template to assist the Government in determining that the EIT products
                                         or services support Section 508 accessibility standards. Instructions for documenting
                                         accessibility via the HHS Section 508 Product Assessment Template may be found on the
                                         HHS Web site ( http://www.hhs.gov/ web/508/contracting/technology/vendors.html).
	 	 	 
	 	 	[(End
                                         of HHSAR 352.239-73(b)]

 

		d.	Prior
                                         to the Contracting Officer exercising an option for a subsequent performance period/additional
                                         quantity or adding funding for a subsequent performance period under this contract, as
                                         applicable, the Contractor must provide a Section 508 Annual Report to the Contracting
                                         Officer and Project Officer. Unless otherwise directed by the Contracting Officer in
                                         writing, the Contractor shall provide the cited report in accordance with the following
                                         schedule. Instructions for completing the report are available in the Section 508 policy
                                         on the HHS Office on Disability Web site under the heading Vendor Information and Documents.
                                         The Contractor's failure to submit a timely and properly completed report may jeopardize
                                         the Contracting Officer's exercising an option or adding funding, as applicable.
	 	 	 
	 	 	Schedule
for Contractor Submission of Section 508 Annual Report:

 

[End
of HHSAR 352.239-73(c)]

 

 

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Contract
Number : HHSN272201400039C

 

ARTICLE
H.27. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

 

The
Institution (includes any contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45
CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that
Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of research funded under NIH contracts, or proposed for such funding,
which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest.
45 CFR Part 94 is available at the following Web site: : http://www.ecfr.gov/cgi-bin/text-idx?
c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 As required by 45
CFR Part 94, the Institution shall, at a minimum:

 

	 	a.	 Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform
each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure of significant financial interests,
and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist,
available to any requestor within five business days of a request. A significant financial interest means a financial interest
consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent
children) that reasonably appears to be related to the Investigator's institutional responsibilities:

 

		1.	With
                                         regard to any publicly traded entity, a significant financial interest exists if the
                                         value of any remuneration received from the entity in the twelve months preceding the
                                         disclosure and the value of any equity interest in the entity as of the date of disclosure,
                                         when aggregated, exceeds $5,000. Included are payments and equity interests;

 

		2.	With
                                         regard to any non-publicly traded entity, a significant financial interest exists if
                                         the value of any remuneration received from the entity in the twelve months preceding
                                         the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's
                                         spouse or dependent children) holds any equity interest; or
	 	 	 
	 	3.	Intellectual
                                         property rights and interests, upon receipt of income related to such rights and interest.

 

Significant financial interests do
not include the following:

 

		1.	Income
                                         from seminars, lectures, or teaching, and service on advisory or review panels for government
                                         agencies, Institutions of higher education, academic teaching hospitals, medical centers,
                                         or research institutes with an Institution of higher learning; and

 

		2.	Income
                                         from investment vehicles, such as mutual funds and retirement accounts, as long as the
                                         Investigator does not directly control the investment decisions made in these vehicles.

 

		b.	Require
    each Investigator to complete training regarding the Institution's financial conflicts of interest policy prior to engaging
    in research related to any NIH-funded contract and at least every four years. The Institution must take reasonable steps [see
    Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.
	 	 	 
		c.	

Designate
an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to
participate in, or is participating in, the NIH-funded research.

	 	 	 
		d.	Require
    that each Investigator who is planning to participate in the NIH-funded research disclose to the Institution's designated
    official(s) the Investigator's significant financial interest (and those of the Investigator's spouse and dependent children)
    no later than the date of submission of the Institution's proposal for NIH-funded research. Require that each Investigator
    who is participating in the NIH-funded research to submit an updated disclosure of significant financial interests at least
    annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well
    as within thirty days of discovering or acquiring a new significant financial interest.

 

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Contract
Number : HHSN272201400039C

 

		e.	Provide
                                         guidelines consistent with the regulations for the designated official(s) to determine
                                         whether an Investigator's significant financial interest is related to NIH-funded research
                                         and, if so related, whether the significant financial interest is a financial conflict
                                         of interest. An Investigator's significant financial interest is related to NIH-funded
                                         research when the Institution, thorough its designated official(s), reasonably determines
                                         that the significant financial interest: Could be affected by the NIH-funded research;
                                         or is in an entity whose financial interest could be affected by the research. A financial
                                         conflict of interest exists when the Institution, through its designated official(s),
                                         reasonably determines that the significant financial interest could directly and significantly
                                         affect the design, conduct, or reporting of the NIH-funded research.

 

		f.	Take
                                         such actions as necessary to manage financial conflicts of interest, including any financial
                                         conflicts of a subcontractor Investigator. Management of an identified financial conflict
                                         of interest requires development and implementation of a management plan and, if necessary,
                                         a retrospective review and mitigation report pursuant to Part 94.5(a).

 

		g.	Provide
                                         initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).

 

		h.	Maintain
                                         records relating to all Investigator disclosures of financial interests and the Institution's
                                         review of, and response to, such disclosures, and all actions under the Institution's
                                         policy or retrospective review, if applicable, for at least 3 years from the date of
                                         final payment or, where applicable, for the other time periods specified in 48 CFR Part
                                         4, subpart 4.7, Contract Records Retention.

 

		i.	Establish
                                         adequate enforcement mechanisms and provide for employee sanctions or other administrative
                                         actions to ensure Investigator compliance as appropriate.

 

		j.	Complete
                                         the certification in Section K - Representations, Certifications, and Other Statements
                                         of Offerors titled "Certification of Institutional Policy on Financial Conflicts
                                         of Interest".

 

If
the failure of an Institution to comply with an Institution's financial conflicts of interest policy or a financial conflict of
interest management plan appears to have biased the design, conduct, or reporting of the NIH-funded research, the Institution
must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider
the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may
include directions to the Institution on how to maintain appropriate objectivity in the NIH-funded research project.

 

The
Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial
interests, and the Institution's review of, and response to, such disclosure, regardless of whether the disclosure resulted in
the Institution's determination of a financial conflict of interests.. The Contracting Officer may require submission of the records
or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer
may decide that a particular financial conflict of interest will bias the objectivity of the NIH-funded research to such an extent
that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance
with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

 

If
the Contracting Officer determines that NIH-funded clinical research, whose purpose is to evaluate the safety or effectiveness
of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial conflict
of interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose
the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously
published presentations.

 

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Contract
Number : HHSN272201400039C

 

ARTICLE
H.28. PUBLICATION AND PUBLICITY

 

In
addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference
in SECTION I of this contract, the Contractor shall acknowledge the support of the National Institutes of Health 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 National Institute of Alergy and Infectious Diseases,
National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201400039C"

 

ARTICLE
H.29. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

 

Anyone
who becomes aware of the existence or apparent existence of fraud, waste and abuse in NIH 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 website to file a complaint on-line is:
http://oig.hhs.gov/fraud/hotline/ and the mailing address is:

 

US
Department of Health and Human Services

Office
of Inspector General

ATTN:
OIG HOTLINE OPERATIONS

P.O.
Box 23489

Washington,
D.C. 20026

 

ARTICLE
H.30. YEAR 2000 COMPLIANCE

 

In
accordance with FAR 39.106, Information Technology acquired under this contract must be Year 2000 compliant as set forth in the
following clause(s):

 

	 	1.	Service
    Involving the Use of Information Technology
	 	 	YEAR
    2000 COMPLIANCE--SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY
	 	 	 
	 	 	The
    Contractor agrees that each item of hardware, software, and firmware used under this contract shall be able to accurately
    process date data (including, but not limited to, calculating, comparing and sequencing) from, into and between the twentieth
    and twenty-first centuries and the Year 1999 and the Year 2000 and leap year calculations.

 

(End
of Clause)

 

ARTICLE
H.31. OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES

 

Unique
research resources arising from NIH-funded research are to be shared with the scientific research community. NIH provides guidance,
entitled, "Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical
Research Resources: Final Notice," (Federal Register Notice, December 23, 1999 [64 FR 72090]), concerning the appropriate
terms for disseminating and acquiring these research resources. This guidance, found at: http://www.gpo.gov/fdsys/pkg/FR-1999-12-23/pdf/99-33292.pdf
is intended to help contractors ensure that the conditions they impose and accept on the transfer of research tools will facilitate
further biomedical research, consistent with the requirements of the Bayh-Dole Act and NIH funding policy.

 

Note:
For the purposes of this Article, the terms, "research tools", "research materials", and "research resources"
are used interchangeably and have the same meaning.

 

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

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Contract
Number : HHSN272201400039C

 

	 	a.	Sharing
    of Model Organisms for Biomedical Research
	 	 	 
	 	 	

A
plan for sharing model organisms shall be completed by the Contractor and incorporated by reference in the contract. The Contractor
shall adhere to this plan and request prior approval of the Contracting Officer for any changes in its plan

 

ARTICLE
H.32. SHARING RESEARCH DATA

 

The
Contractor's data sharing plan, dated October 2, 2013 is hereby incorporated by reference. The Contractor agrees to adhere to
its plan and shall request prior approval of the Contracting Officer for any changes in its plan.

 

The
NIH endorses the sharing of final research data to serve health. This contract is expected to generate research data that must
be shared with the public and other researchers. NIH's data sharing policy may be found at the following Web site:

 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

 

NIH
recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well
as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-published documentation on the Privacy Rule
at http://www.hhs.gov/ocr/). The rights and privacy of people who participate
in NIH-funded research must be protected at all times; thus, data intended for broader use should be free of identifiers that
would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity
of individual subjects.

 

ARTICLE
H.33. POSSESSION USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

 

The
work being conducted under this contract may involve the possession, use, or transfer of a select agent or toxin. The contractor
shall not conduct work involving a Select Agent or Toxin under this contract until it and any associated subcontractor(s) comply
with the following:

 

For
prime or subcontract awards to domestic institutions that possess, use, and/or transfer a Select Agent or Toxin
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.selectagents.gov/Regulations.html) as required, before using NIH funds for work involving a Select Agent
or Toxin. No NIH 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 NIH funds for any work directly involving a Select Agent or Toxin, the foreign institution must provide information
satisfactory to the NIAID 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 a site visit to the foreign laboratory facility by an NIAID
representative. During this visit, 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 Agent or Toxin
and procedures for ensuring that only approved and appropriate individuals, in accordance with institution procedures, will have
access to the Select Agents or Toxins 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. Site
visits to foreign laboratories are conducted every three years after the initial review. No NIH funds can be used for work
involving a Select Agent or Toxin at a foreign institution without written approval from the Contracting Officer.

 

 

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Contract
Number : HHSN272201400039C

 

Prior
to conducting a restricted experiment with a Select Agent or Toxin under this contract or any associated subcontract, the contractor
must discuss the experiment with the Contracting Officer's Representative (COR) and request and obtain written approval from the
Contracting Officer. Domestic institutions must submit to the Contracting Officer written approval from the CDC to perform
the proposed restricted experiment. Foreign institutions require review by a NIAID representative. The prime contractor
must contact the COR and the NIAID Office of International Extramural Activities (OIEA) at mailto:niaidforeignawards@niaid.nih.gov
for guidance on the process used by NIAID to review proposed restricted experiments. The NIAID website provides an overview
of the review process at http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/saconproc.aspx. The Contracting Officer
will notify the prime contractor when the process is complete. No NIH funds can be used for a restricted experiment with a
Select Agent or Toxin at either a domestic or foreign institution without written approval from the Contracting Officer.

 

Listings
of HHS and USDA 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.selectagents.gov/ and
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.

 

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

(
http://funding.niaid.nih.gov/researchfunding/sci/biod/pages/default.aspx ).

 

ARTICLE
H.34. HIGHLY PATHOGENIC AGENTS

 

The
work being conducted under this contract may involve a Highly Pathogenic Agent (HPA). The NIAID defines an HPA as a pathogen
that, under any circumstances, warrants a biocontainment safety level of BSL3 or higher according to either:

 

		1.	The
                                         current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories
                                         (BMBL)( http:// www.cdc.gov/biosafety/publications/index.htm under "Publications);

 

		2.	The
                                         Contractor's Institutional Biosafety Committee (IBC) or equivalent body; or

 

		3.	The
                                         Contractor's appropriate designated institutional biosafety official.

 

If
there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an IBC or equivalent body, or institutional
biosafety official, the highest recommended containment level must be used.

 

ARTICLE
H.35. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)

 

Pursuant
to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting, convention, conference or
training seminar that is conducted in, or that otherwise uses the rooms, facilities, or services of a place of public accommodation
that do not meet the requirements of the fire prevention and control guidelines as described in the Public Law. This restriction
applies to public accommodations both foreign and domestic.

 

Public
accommodations that meet the requirements can be accessed at: http://apps.usfa.fema.gov/hotel/.

 

ARTICLE
H.36. 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.37. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

 

The
Contractor shall not use contract funds (direct or indirect) to conduct meetings or conferences in performance of this contract
without prior written Contracting Officer approval.

 

In
addition, the use of contract funds to purchase food for meals, light refreshments, or beverages is expressly prohibited.

 

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-37-

    	 

    

 

Contract
Number : HHSN272201400039C

 

The
following conferences and/or meetings have been approved by the Contracting Officer and are hereby authorized under this contract:

 

	Conference
    or Meeting Title	Conference
    or 

    Meeting Location	Federal/NonFederal
    

    Space	Date
    of Conference	Not
    to Exceed 

    Estimate Cost
	 	 	☐
                                         Federal

         

        ☐
        NonFederal
	 	 
	 	 	☐
    Federal
         

        ☐
        NonFederal
	 	 
	 	 	☐
    Federal
         

        ☐
        NonFederal
	 	 
	 	 	☐
    Federal
         

        ☐
        NonFederal
	 	 

 

 

 

ARTICLE
H.38. USE OF FUNDS FOR PROMOTIONAL ITEMS

 

The
Contractor shall not use contract funds to purchase promotional items. Promotional items include, but are not limited to: clothing
and commemorative items such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes provided to
visitors, employees, grantees, or conference attendees. This includes items or tokens given to individuals as these are considered
personal gifts for which contract funds may not be expended.

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

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Contract
Number : HHSN272201400039C

 

PART
II - CONTRACT CLAUSES

 

SECTION I - CONTRACT CLAUSES

 

ARTICLE
I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT

 

This
contract incorporates the following 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
as follows: FAR Clauses at: http://www.acquisition.gov/far/. HHSAR Clauses at: http:// www.hhs.gov/policies/hhsar/subpart352.html.

 

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

 

	FAR

    CLAUSE NO.	 	DATE	 	TITLE
	52.202-1	 	Nov
    2013	 	Definitions
    (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-3	 	Apr
    1984	 	Gratuities
    (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-5	 	May
    2014	 	Covenant
    Against Contingent Fees (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-6	 	Sep
    2006	 	Restrictions
    on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)
	 	 	 	 	
	52.203-7	 	May
    2014	 	Anti-Kickback
    Procedures (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-8	 	May
    2014	 	Cancellation,
    Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
	 	 	 	 	
	52.203-10	 	May
    2014	 	Price
    or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
	 	 	 	 	
	52.203-12	 	Oct
    2010	 	Limitation
    on Payments to Influence Certain Federal Transactions (Over $150,000)
	 	 	 	 	 
	52.203-17	 	Apr
    2014	 	Contractor
    Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition
    Threshold)
	 	 	 	 	
	52.204-4	 	May
    2011	 	Printed
    or Copied Double-Sided on Postconsumer Fiber Content Paper(Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.204-10	 	Jul
    2013	 	Reporting
    Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)
	 	 	 	 	
	52.204-13	 	Jul
    2013	 	System
    for Award Management Maintenance
	 	 	 	 	 
	52.209-6	 	Aug
    2013	 	Protecting
    the Government's Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over
    $30,000)
	 	 	 	 	
	52.215-2	 	Oct
    2010	 	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 the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]
	 	 	 	 	 
	52.215-8	 	Oct
    1997	 	Order
    of Precedence - Uniform Contract Format
	 	 	 	 	 
	52.215-10	 	Aug
    2011	 	Price
    Reduction for Defective Certified Cost or Pricing Data (Over $700,000)
	 	 	 	 	 
	52.215-12	 	Oct
    2010	 	Subcontractor
    Cost or Pricing Data (Over $700,000)
	 	 	 	 	 
	52.215-14	 	Oct
    2010	 	Integrity
    of Unit Prices (Over the Simplified Acquisition Threshold)

 

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Contract
    Number : HHSN272201400039C

 

	FAR
    

    CLAUSE NO.	 	DATE	 	TITLE
	52.215-15	 	Oct
    2010	 	Pension
    Adjustments and Asset Reversions (Over $700,000)
	 	 	 	 	 
	52.215-18	 	Jul
    2005	 	Reversion
    or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
	 	 	 	 	 
	52.215-19	 	Oct
    1997	 	Notification
    of Ownership Changes
	 	 	 	 	 
	52.215-21	 	Oct
    2010	 	Requirements
    for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications
	 	 	 	 	 
	52.215-23	 	Oct
    2009	 	Limitations
    on Pass-Through Charges (Over the Simplified Acquisition Threshold)
	 	 	 	 	
	52.216-7	 	Jun
    2013	 	Allowable
    Cost and Payment
	 	 	 	 	 
	52.216-8	 	Jun
    2011	 	Fixed
    Fee
	 	 	 	 	 
	52.219-8	 	May
    2014	 	Utilization
    of Small Business Concerns (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.219-9	 	Jul
    2013	 	Small
    Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)
	 	 	 	 	
	52.219-16	 	Jan
    1999	 	Liquidated
    Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction)
	 	 	 	 	 
	52.222-2	 	Jul
    1990	 	Payment
    for Overtime Premium (Over the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this
    clause is $0 unless otherwise specified in the contract.)
	 	 	 	 	
	52.222-3	 	Jun
    2003	 	Convict
    Labor
	 	 	 	 	 
	52.222-21	 	Feb
    1999	 	Prohibition
    of Segregated Facilities
	 	 	 	 	 
	52.222-26	 	Mar
    2007	 	Equal
    Opportunity
	 	 	 	 	 
	52.222-35	 	Jul
    2014	 	Equal
    Opportunity for Veterans ($100,000 or more)
	 	 	 	 	 
	52.222-36	 	Jul
    2014	 	Equal
    Opportunity for Workers with Disabilities
	 	 	 	 	 
	52.222-37	 	Jul
    2014	 	Employment
    Reports on Veterans ($100,000 or more)
	 	 	 	 	 
	52.222-40	 	Dec
    2010	 	Notification
    of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)
	 	 	 	 	
	52.222-50	 	Feb
    2009	 	Combating
    Trafficking in Persons
	 	 	 	 	 
	52.222-54	 	Aug
    2013	 	Employment
    Eligibility Verification (Over the Simplified Acquisition Threshold)
	 	 	 	 	
	52.223-6	 	May
    2001	 	Drug-Free
    Workplace
	 	 	 	 	 
	52.223-18	 	Aug
    2011	 	Encouraging
    Contractor Policies to Ban Text Messaging While Driving
	 	 	 	 	 
	52.225-1	 	May
    2014	 	Buy
    American - Supplies
	 	 	 	 	 
	52.225-13	 	Jun
    2008	 	Restrictions
    on Certain Foreign Purchases
	 	 	 	 	 
	52.227-1	 	Dec
    2007	 	Authorization
    and Consent, Alternate I (Apr 1984)
	 	 	 	 	 
	52.227-2	 	Dec
    2007	 	Notice
    and Assistance Regarding Patent and Copyright Infringement
	 	 	 	 	 
	52.227-11	 	May
    2014	 	Patent
    Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include
    the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
	 	 	 	 	 
	52.227-14	 	May
    2014	 	Rights
    in Data - General
	 	 	 	 	 
	52.232-9
	 	Apr
    1984	 	Limitation
    on Withholding of Payments
	 	 	 	 	 
	52.232-17	 	May
    2014	 	Interest
    (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.232-20	 	Apr
    1984	 	Limitation
    of Cost

 

 

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Contract
Number : HHSN272201400039C

 	FAR

    CLAUSE NO.	 	DATE	 	TITLE
	52.232-23	 	May
    2014	 	Assignment
    of Claims
	 	 	 	 	 
	52.232-25	 	Jul
    2013	 	Prompt
    Payment, Alternate I (Feb 2002)
	 	 	 	 	 
	52.232-33	 	Jul
    2013	 	Payment
    by Electronic Funds Transfer--System for Award Management
	 	 	 	 	 
	52.232-39	 	Jun
    2013	 	Unenforceability
    of Unauthorized Obligations
	 	 	 	 	 
	52.233-1	 	May
    2014	 	Disputes
	 	 	 	 	 
	52.233-3	 	Aug
    1996	 	Protest
    After Award, Alternate I (Jun 1985)
	 	 	 	 	 
	52.233-4	 	Oct
    2004	 	Applicable
    Law for Breach of Contract Claim
	 	 	 	 	 
	52.242-1	 	Apr
    1984	 	Notice
    of Intent to Disallow Costs
	 	 	 	 	 
	52.242-3	 	May
    2014	 	Penalties
    for Unallowable Costs (Over $700,000)
	 	 	 	 	 
	52.242-4	 	Jan
    1997	 	Certification
    of Final Indirect Costs
	 	 	 	 	 
	52.242-13	 	Jul
    1995	 	Bankruptcy
    (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.243-2	 	Aug
    1987	 	Changes
    - Cost Reimbursement, Alternate V (Apr 1984)
	 	 	 	 	 
	52.244-2	 	Oct
    2010	 	Subcontracts
    (Over the Simplified Acquisition Threshold), Alternate I (June
    2007)
	 	 	 	 	 
	52.244-5	 	Dec
    1996	 	Competition
    in Subcontracting (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.244-6	 	Jul
    2014	 	Subcontracts
    for Commercial Items
	 	 	 	 	 
	52.245-1	 	Apr
    2012	 	Government
    Property
	 	 	 	 	 
	52.245-9	 	Apr
    2012	 	Use
    and Charges
	 	 	 	 	 
	52.246-23	 	Feb
    1997	 	Limitation
    of Liability (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.249-6	 	May
    2004	 	Termination
    (Cost-Reimbursement)
	 	 	 	 	 
	52.249-14	 	Apr
    1984	 	Excusable
    Delays
	 	 	 	 	 
	52.253-1	 	Jan
    1991	 	Computer
    Generated Forms

 

b.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

	HHSAR

CLAUSE
    NO.	 	DATE	 	TITLE
	352.202-1	 	Jan 2006	 	Definitions - with Alternate
    paragraph (h) (Jan 2006)
	 	 	 	 	 
	352.203-70	 	Mar 2012	 	Anti-Lobbying
	 	 	 	 	 
	352.216-70	 	Jan 2006	 	Additional Cost Principles
	 	 	 	 	 
	352.222-70	 	Jan 2010	 	Contractor Cooperation
    in Equal Employment Opportunity Investigations
	 	 	 	 	 
	352.227-70	 	Jan 2006	 	Publications and Publicity
	 	 	 	 	 
	352.228-7	 	Dec 1991	 	Insurance - Liability
    to Third Persons
	 	 	 	 	 
	352.233-71	 	Jan 2006	 	Litigation and Claims
	 	 	 	 	 
	352.242-70	 	Jan 2006	 	Key Personnel
	 	 	 	 	 
	352.242-73	 	Jan 2006	 	Withholding of Contract
    Payments
	 	 	 	 	 
	352.242-74	 	Apr 1984	 	Final Decisions on Audit
    Findings

 

[End
of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 08/2014].

 

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-41-

    	 

    

 

Contract
Number : HHSN272201400039C

 

ARTICLE
I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

 

ARTICLE
I.1. of this SECTION is hereby modified as follows:

 

		a.	FAR
                                         Clauses 52.219-9, Small Business Subcontracting Plan (July 2013), and 52.219-16,
                                         Liquidated Damages—Subcontracting Plan (January 1999) are deleted in their
                                         entirety.

 

b.  Alternate
I, (December 1991), of FAR Clause 52.233-1, Disputes (May 2014) is added.

 

ARTICLE
I.3. Additional Contract Clauses

 

This
contract incorporates the following 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.

 

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

 

		1.	FAR
                                         Clause 52.203-13, Contractor Code of Business Ethics and Conduct (April 2010).

 

2.
 FAR Clause 52.203-14, Display of Hotline Poster(s) (December 2007).

 

"(3)
Any required posters may be obtained as follows:

 

	Poster(s)	Obtain
    From"
	
        HHS
        Contractor Code of Ethics 

        and Business Conduct Poster
	http://oig.hhs.gov/fraud/report-

        fraud/OIG_Hotline_Poster.pdf

 

3.
 FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

 

4.
 FAR Clause 52.217-7, Option for Increased Quantity - Separately Priced Line Item (March 1989).

 

"....The
Contracting Officer may exercise the option by written notice to the Contractor within 60 days before the contract expires or
prior to the exercise of the options ...."

 

		5.	FAR
                                         Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
                                         Concerns (January 2011).

 

"(c)
Waiver of evaluation preference

[
] Offeror elects to waive the evaluation preference."

 

		6.	FAR
Clause 52.2 19-28, Post-Award Small Business Program Rerepresentation (July 2013).

 

		7.	FAR
                                         Clause 52.224-1, Privacy Act Notification (April 1984).

 

		8.	FAR
Clause 52.224-2, Privacy Act (April 1984). 

 

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-42-

    	 

    

 

Contract
Number : HHSN272201400039C

 

9.
  Alternate II (December 2007), FAR Clause 52.227-14, Rights in Data—General (December 2007).

 

Additional purposes
for which the limited rights data may be used are:

 

(i)Use
(except for manufacture) by support service contract.

 

(ii)Evaluation
by nongovernmental evaluators.

 

(iii)Use
(except for manufacture) by other contractors participating in the Government's program of which the specific contract is a part

 

10.  Alternate V (December 2007), FAR Clause 52.227-14, Rights in Data—General (December 2007). Specific data items
that are not subject to paragraph (j) include: None

 

11.
   FAR Clause 52.227-16, Additional Data Requirements (June 1987).

 

12.
   FAR Clause 52.227-17, Rights in Data—Special Works (December 2007).

 

13.
   FAR Clause 52.232-18, Availability of Funds (April 1984).

 

14.
   FAR Clause 52.239-1, Privacy or Security Safeguards (August 1996).

 

15.
   FAR Clause 52.247-68, Report of Shipment (REPSHIP) (February 2006).

 

16.
   FAR Clause 52.251-1, Government Supply Sources (April 2012).

 

b.
  DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:

 

		1.	HHSAR
                                         Clause 352.201-70, Paperwork Reduction Act (January 2006).

 

		2.	HHSAR
                                         Clause 352.223-70, Safety and Health (January 2006).

 

		3.	HHSAR
                                         Clause 352.231-70, Salary Rate Limitation (August 2012).

 

Note: P.L.
113-76 sets forth the Salary Rate Limitation at the Executive Level II Rate, effective January 17, 2014.

 

See
the following website for Executive Schedule rates of pay: http://www.opm.gov/oca/ .

 

(For
current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates,
click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule.
Rates are effective January 1 of each calendar year unless otherwise noted.)

 

		4.	HHSAR
                                         Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to Persons with
                                         Disabilities (January 2001).

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-43-

    	 

    

 

Contract
Number : HHSN272201400039C

 

c.
  NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC) CLAUSES:

 

The
following clauses are attached and made a part of this contract:

 

1.
  NIH(RC)-11, Research Patient Care Costs (4/1/84).

 

ARTICLE
I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

 

This
contract incorporates the following clauses in full text.

 

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

 

1.
  FAR Clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (July
2013)

 

As
prescribed in 32.706-1(b), insert the following clause:

 

a.
 The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a
semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management
(SAM) database at http://www.acquisition.gov.

 

b.
  As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub. L. 111-212), all information posted in FAPIIS on
or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two

segments— —

 

1.
  The non-public segment, into which Government officials and the Contractor post information, which can only be
viewed by— —

 

		i.	Government
                                         personnel and authorized users performing business on behalf of the Government; or

 

		ii.	The
                                         Contractor, when viewing data on itself; and

 

2.
  The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting
period of 14 calendar days, except for—

 

		i.	Past
                                         performance reviews required by subpart 42.15;

 

		ii.	Information
                                         that was entered prior to April 15, 2011; or

 

		iii.	Information
                                         that is withdrawn during the 14-calendar-day waiting period by the Government official
                                         who posted it in accordance with paragraph (c)(1) of this clause.

 

c.
  The Contractor will receive notification when the Government posts new information to the Contractor's record.

 

		1.	If
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              Contractor
                                                                                                                                                                                                                                              asserts
                                                                                                                                                                                                                                              in
                                                                                                                                                                                                                                              writing
                                                                                                                                                                                                                                              within
                                                                                                                                                                                                                                              7
                                                                                                                                                                                                                                              calendar
                                                                                                                                                                                                                                              days,
                                                                                                                                                                                                                                              to
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              Government
                                                                                                                                                                                                                                              official
                                                                                                                                                                                                                                              who
                                                                                                                                                                                                                                              posted
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              information,
                                                                                                                                                                                                                                              that
                                                                                                                                                                                                                                              some
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              information
                                                                                                                                                                                                                                              posted
                                                                                                                                                                                                                                              to
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              non-public
                                                                                                                                                                                                                                              segment
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              FAPIIS
                                                                                                                                                                                                                                              is
                                                                                                                                                                                                                                              covered
                                                                                                                                                                                                                                              by
                                                                                                                                                                                                                                              a
                                                                                                                                                                                                                                              disclosure
                                                                                                                                                                                                                                              exemption
                                                                                                                                                                                                                                              under
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              Freedom
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              Information
                                                                                                                                                                                                                                              Act,
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              Government
                                                                                                                                                                                                                                              official
                                                                                                                                                                                                                                              who
                                                                                                                                                                                                                                              posted
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              information
                                                                                                                                                                                                                                              must
                                                                                                                                                                                                                                              within
                                                                                                                                                                                                                                              7
                                                                                                                                                                                                                                              calendar
                                                                                                                                                                                                                                              days
                                                                                                                                                                                                                                              remove
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              posting
                                                                                                                                                                                                                                              from
                                                                                                                                                                                                                                              FAPIIS
                                                                                                                                                                                                                                              and
                                                                                                                                                                                                                                              resolve
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              issue
                                                                                                                                                                                                                                              in
                                                                                                                                                                                                                                              accordance
                                                                                                                                                                                                                                              with
                                                                                                                                                                                                                                              agency
                                                                                                                                                                                                                                              Freedom
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              Information
                                                                                                                                                                                                                                              procedures,
                                                                                                                                                                                                                                              prior
                                                                                                                                                                                                                                              to
                                                                                                                                                                                                                                              reposting
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              releasable
                                                                                                                                                                                                                                              information.
                                                                                                                                                                                                                                              The
                                                                                                                                                                                                                                              contractor
                                                                                                                                                                                                                                              must
                                                                                                                                                                                                                                              cite
                                                                                                                                                                                                                                              52.209-9
                                                                                                                                                                                                                                              and
                                                                                                                                                                                                                                              request
                                                                                                                                                                                                                                              removal
                                                                                                                                                                                                                                              within
                                                                                                                                                                                                                                              7
                                                                                                                                                                                                                                              calendar
                                                                                                                                                                                                                                              days
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              posting
                                                                                                                                                                                                                                              to
                                                                                                                                                                                                                                              FAPIIS.

 

		2.	The
                                                                                                                                                                                                                                              Contractor
                                                                                                                                                                                                                                              will
                                                                                                                                                                                                                                              also
                                                                                                                                                                                                                                              have
                                                                                                                                                                                                                                              an
                                                                                                                                                                                                                                              opportunity
                                                                                                                                                                                                                                              to
                                                                                                                                                                                                                                              post
                                                                                                                                                                                                                                              comments
                                                                                                                                                                                                                                              regarding
                                                                                                                                                                                                                                              information
                                                                                                                                                                                                                                              that
                                                                                                                                                                                                                                              has
                                                                                                                                                                                                                                              been
                                                                                                                                                                                                                                              posted
                                                                                                                                                                                                                                              by
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              Government.
                                                                                                                                                                                                                                              The
                                                                                                                                                                                                                                              comments
                                                                                                                                                                                                                                              will
                                                                                                                                                                                                                                              be
                                                                                                                                                                                                                                              retained
                                                                                                                                                                                                                                              as
                                                                                                                                                                                                                                              long
                                                                                                                                                                                                                                              as
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              associated
                                                                                                                                                                                                                                              information
                                                                                                                                                                                                                                              is
                                                                                                                                                                                                                                              retained,
                                                                                                                                                                                                                                              i.e.,
                                                                                                                                                                                                                                              for
                                                                                                                                                                                                                                              a
                                                                                                                                                                                                                                              total
                                                                                                                                                                                                                                              period
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              6
                                                                                                                                                                                                                                              years.
                                                                                                                                                                                                                                              Contractor
                                                                                                                                                                                                                                              comments
                                                                                                                                                                                                                                              will
                                                                                                                                                                                                                                              remain
                                                                                                                                                                                                                                              a
                                                                                                                                                                                                                                              part
                                                                                                                                                                                                                                              of
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              record
                                                                                                                                                                                                                                              unless
                                                                                                                                                                                                                                              the
                                                                                                                                                                                                                                              Contractor
                                                                                                                                                                                                                                              revises
                                                                                                                                                                                                                                              them 

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-44-

    	 

    

 

Contract
Number : HHSN272201400039C

 

3.
  As required by section 3010 of Pub. L. 111-212, all information posted in FAPIIS on or after April 15, 2011, except past performance
reviews, will be publicly available.

 

d.
  Public requests for system information posted prior to April 15, 2011, will be handled under Freedom of Information Act procedures,
including, where appropriate, procedures promulgated under E.O. 12600.

 

(End
of clause)

 

b.
  DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CHAPTER 3) CLAUSES:

 

None

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-45-

    	 

    

 
 Contract
Number : HHSN272201400039C

 

PART
III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

SECTION J - LIST OF ATTACHMENTS

 

The
following documents are attached and incorporated in this contract:

 

1.Statement
of Work

 

Statement
of Work, dated September 16, 2014, 15 pages.

 

2.Invoice/Financing
Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4

 

Invoice/Financing
Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4, (8/12), 6 pages.

 

3.Cumulative
Inclusion Enrollment Report

 

Cumulative
Inclusion Enrollment Report, PHS 398/2590, (Rev. 08/12), 1 page. Located at:

 

http://grants.nih.gov/grants/funding/phs398/CumulativeInclusionEnrollmentReport.pdf

 

4.Privacy
Act System of Records, Number Privacy

 

Act System of Records, Number 09-25-0200

 

5.Safety
and Health

 

Safety
and Health, HHSAR Clause 352.223-70, (1/06), 1 page.

 

6.Research
Patient Care Costs

 

Research
Patient Care Costs, NIH(RC)-11, 4/1/84, 1 page.

 

7.Disclosure
of Lobbying Activities, SF-LLL 

 

Disclosure
of Lobbying Activities, SF-LLL, dated 7/97, 2 pages.

 

 8.Roster
of Employees Requiring Suitability Investigations

 

Roster
of Employees Requiring Suitability Investigations, 1 page. Excel file located at: https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx

 

9.Employee
Separation Checklist

 

Employee
Separation Checklist, 1 page. Fillable PDF format located at: https://ocio.nih.gov/aboutus/publicinfosecurity/ acquisition/Documents/Emp-sep-checklist.pdf

 

 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

    	-46-

    	 

    

 

Contract
Number : HHSN272201400039C

 

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

 

The
following documents are incorporated by reference in this contract:

 

		1.	Annual
                                                                                                                                                                                                                 Representations
                                                                                                                                                                                                                 and
                                                                                                                                                                                                                 Certifications
                                                                                                                                                                                                                 are
                                                                                                                                                                                                                 completed
                                                                                                                                                                                                                 and
                                                                                                                                                                                                                 located
                                                                                                                                                                                                                 in
                                                                                                                                                                                                                 The
                                                                                                                                                                                                                 System
                                                                                                                                                                                                                 for
                                                                                                                                                                                                                 Award
                                                                                                                                                                                                                 Management
                                                                                                                                                                                                                 (SAM)
                                                                                                                                                                                                                 website
                                                                                                                                                                                                                 (
                                                                                                                                                                                                                 http://www.sam.gov).

  

		2.	NIH
                                         Representations & Certifications, dated November 8, 2013

 

3.
Human Subjects Assurance Identification Number [*****].

 

		4.	Animal
                                                                                                                                                                                                                 Welfare
                                                                                                                                                                                                                 Assurance
                                                                                                                                                                                                                 Number
                                                                                                                                                                                                                 Not
                                                                                                                                                                                                                 Applicable.

                                                                                                                                                                                                                 

[*****]

  

END
of the SCHEDULE

 

(CONTRACT) 

 

Portions herein identified by [*****] have been omitted
pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete
copy of this document has been filed separately with the Securities and Exchange Commisson. 

	 	 	DM3/3022892.1		CONFIDENTIAL

 

 

-47-Exhibit 10.1

 

September 22, 2014

 

HAND DELIVERED

 

Mr. Ken Hartwick 
 5100 14th Side Road
 Milton Ontario L9T 2Y1
 Canada

 

Dear Ken:

 

Re:  Offer of Employment

 

On behalf of the Board of Directors, it is with pleasure that I offer you temporary/interim employment with Atlantic Power Corporation (the “Company”).

 

The key terms of the Company’s offer of employment are as follows (once signed by you confirming your acceptance, this letter will also be referred to as “this Agreement”):

 

1.                                      Start Date

 

Your start date will be September 15, 2014.

 

2.                                      Position/Role

 

You will be employed in the position of Interim President and Chief Executive Officer. In its discretion, the Company may also assign you other positions with its affiliates.

 

To be clear, your employment is temporary and on an interim basis pending the Company hiring a permanent President and Chief Executive Officer.

 

Reporting directly to the Company’s Board of Directors, you will have duties and responsibilities as the most senior management executive of the Company.  You will perform all duties in accordance with the charter documents and by-laws of the Company, the instructions of the Board of Directors, and the Company’s policies and codes of conduct, rules and regulations as they are amended from time to time.

 

Your employment will be at the Company’s Canadian office(s) located at 123 Front Street, Suite 1620, Toronto, Ontario, but with regular travel to the organization’s headquarters in Boston, MA.

 

Your employment is full-time and exclusive to the Company (including, if applicable, its affiliates).

 

 

3.                                      Compensation

 

During your employment with the Company (but excluding any leaves of absence), you will be paid a base salary at the rate of US$500,000 per year, payable on a regular payroll basis consistent with other employees of the Company in Canada.

 

You will be reimbursed for all reasonable travel and other out-of-pocket expenses actually and properly incurred by you in accordance with the Company’s policies from time to time in connection with carrying out your duties and responsibilities.  For all such expenses, you will furnish to the Company invoices or statements in respect of which you seek reimbursement.

 

You will not be eligible for any bonus or other group insurance or other employment benefits from the Company or any of its affiliates.

 

To the extent that you serve as a director or officer of the Company or of any of its affiliates during your employment, you will do so without any additional remuneration.

 

4.                                      Term/Termination

 

Your employment is on a temporary and interim basis pending the Company hiring a permanent President and Chief Executive Officer; upon such hiring, your employment will end automatically without further notice to you and without any termination pay or severance pay or similar payments or benefits (except as may require by the ESA as set out in the following paragraph).

 

At any time and for any reason, the Company may terminate your employment. On any termination for just cause, no notice of termination, termination pay or severance pay or similar payments or benefits will be provided. Otherwise, the Company’s sole obligation in such circumstances will be to provide you with the minimums mandated by the Employment Standards Act, 2000 (Ontario) or such other employment/labour standards governing your employment with the Company (the “ESA”) including all requirements set out in the ESA with respect to notice of termination or termination pay in lieu of notice of termination, severance pay (if applicable) and continuation of benefits (if any); for certainty, the foregoing is deemed to satisfy all of the Company’s obligations in connection with the termination of your employment, whether statutory, contractual or at common law.

 

You agree to provide four weeks’ advance written notice of your intention to resign your employment. The Company may waive the notice, in whole or in part, subject to the Company’s obligation to pay you your base salary until the effective date of resignation.

 

Upon any cessation of your employment with the Company (howsoever caused), you will be paid all compensation earned by you up to the date that you cease employment or as may be required by the ESA; no additional payments or benefits following the date of the cessation of your employment will be provided to you other than as specifically set out in this Agreement.  The provisions of the ESA shall be deemed to be incorporated into this Agreement; as legislation is changed, this Agreement shall be deemed amended so as to comply with such legislation to the extent greater wages or benefits are provided therein.

 

2

 

For greater certainty, in no circumstances shall you be provided any less than the minimum requirements of the ESA.

 

5.                                      Policies

 

It is a condition of this Agreement and of your continued employment with the Company that you abide by the Company’s policies and procedures as they may amended from time to time.

 

6.                                      Personal Information

 

For purposes of processing or administering your employment relationship, the Company may transfer your personal information to affiliates or to agents and contractors (such as payroll companies, insurance companies, information technology consultants, etc.) that provide services to the Company.

 

7.                                      General

 

(a)                                 Withholdings:  You are responsible for all tax liability resulting from any receipt of payments or benefits or other entitlements from the Company or pursuant to this Agreement and, further, all compensation are less applicable withholdings and deductions.

 

(b)                                 Changes:  Unless specifically amended in writing and signed by the parties, the terms of this Agreement will continue to apply notwithstanding the passage of time or any changes in your position, duties, reporting or other terms of employment.

 

(c)                                  Assignment of Rights:  Your rights under this Agreement cannot be assigned or transferred by you in any manner. Except with your prior written consent, the Company shall not have the right to assign this Agreement to any other entity.

 

(d)                                 Severability:  If a court or tribunal of competent jurisdiction deems any provision of this Agreement to be void or invalid, such void or invalid provisions shall be severed from this Agreement and the remaining provisions of this Agreement shall remain in full force and effect.

 

(e)                                  Entire Agreement: This Agreement supersedes and replaces all prior or contemporaneous negotiations and/or agreements, whether oral or written and the execution of this Agreement has not been induced by, nor do any of the parties hereto rely upon or regard as material any representations or writings whatsoever not incorporated into and made a part of this Agreement. This Agreement, together with the Company’s policies and procedures as they may be changed from time to time, shall constitute the entire agreement with respect to all matters relating to your employment with the Company. Any amendment to this Agreement must be in writing and signed by you and the Company.

 

***

 

3

 

We look forward to the contributions you will make to the Company’s executive team.

 

To accept this offer, please sign and date the acceptance below and return a full copy to me via email at irg@allstream.net with an original to follow.

 

Sincerely,

 

ATLANTIC POWER CORPORATION.

 

 

	
/s/ Irving Gerstein
    	
 
    
	
Irving Gerstein, Chairman of the Board
    	
 
    

 

Acceptance:

 

I have read and I understand the terms and conditions of employment set out in this Agreement and I accept them freely and voluntarily.  I confirm that I have had the opportunity to obtain advice regarding its contents, including from counsel of my choice.

 

Signed at the City of Toronto on September 22, 2014.

 

 

	
 
    	
/s/ Kenneth Hartwick
    
	
 
    	
Kenneth Hartwick
    

 

4

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