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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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Contract Number : HHSN272201400039C

 

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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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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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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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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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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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 Health

National 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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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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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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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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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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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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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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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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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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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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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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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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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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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.

 

 

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  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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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.

 

 

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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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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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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

 

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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).

 

 

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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

 

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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 

 

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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

 

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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

 

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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

 

 

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