Exhibit 10.1
 
[img002.jpg]
 
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 : HHSN272201300030C
 
CONTRACT TABLE OF CONTENTS
 

PART I - THE SCHEDULE  4   SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS 4  
  ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES   4     ARTICLE B.2. ESTIMATED COST
- OPTION  4     ARTICLE B.3. ADVANCE UNDERSTANDINGS  4     ARTICLE B.4.
PROVISIONS APPLICABLE TO DIRECT COSTS  6           SECTION C -
DESCRIPTION/SPECIFICATIONS/WORK STATEMENT  8     ARTICLE C.1. STATEMENT OF WORK
 8     ARTICLE C.2. REPORTING REQUIREMENTS   8     ARTICLE C.3. INVENTION
REPORTING REQUIREMENT  9           SECTION D - PACKAGING, MARKING AND SHIPPING
 11           SECTION E - INSPECTION AND ACCEPTANCE  12           SECTION F -
DELIVERIES OR PERFORMANCE  13     ARTICLE F.1. PERIOD OF PERFORMANCE  13    
ARTICLE F.2. DELIVERIES.  13     ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE,
FAR 52.252-2 (FEBRUARY 1998)   13           SECTION G - CONTRACT ADMINISTRATION
DATA  14     ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)  14    
ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)  14     ARTICLE G.3.
INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT  14
    ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS 
 16     ARTICLE G.5. INDIRECT COST RATES  16     ARTICLE G.6. POST AWARD
EVALUATION OF CONTRACTOR PERFORMANCE  17           SECTION H - SPECIAL CONTRACT
REQUIREMENTS  18     ARTICLE H.1. HUMAN SUBJECTS  18     ARTICLE H.2. NIH POLICY
ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED
RESEARCH  18     ARTICLE H.3. NEEDLE DISTRIBUTION  18     ARTICLE H.4.
ACKNOWLEDGEMENT OF FEDERAL FUNDING   18     ARTICLE H.5. CONTINUED BAN ON
FUNDING OF HUMAN EMBRYO RESEARCH  18     ARTICLE H.6. DISSEMINATION OF FALSE OR
DELIBERATELY MISLEADING INFORMATION  18     ARTICLE H.7. CARE OF LIVE VERTEBRATE
ANIMALS, HHSAR 352.270-5(b) (October 2009)  19     ARTICLE H.8. ANIMAL WELFARE
 19     ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS  19     ARTICLE
H.10. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES  20

 
 
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Contract Number : HHSN272201300030C
 

    ARTICLE H.11. OPTION PROVISION  20     ARTICLE H.12. INFORMATION AND
PHYSICAL ACCESS SECURITY  20     ARTICLE H.13. ELECTRONIC AND INFORMATION
TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010)  27     ARTICLE
H.14. CONFIDENTIALITY OF INFORMATION  27     ARTICLE H.15. INSTITUTIONAL
RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OFINTEREST  28    
ARTICLE H.16. PUBLICATION AND PUBLICITY  30     ARTICLE H.17. REPORTING MATTERS
INVOLVING FRAUD, WASTE AND ABUSE  30     ARTICLE H.18. YEAR 2000 COMPLIANCE   30
    ARTICLE H.19. SHARING RESEARCH DATA  31     ARTICLE H.20. HOTEL AND MOTEL
FIRE SAFETY ACT OF 1990 (P.L. 101-391)   31     ARTICLE H.21. PROHIBITION ON
CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES  31     ARTICLE H.22. USE OF
FUNDS FOR CONFERENCES, MEETINGS AND FOOD  31         PART II - CONTRACT CLAUSES 
 33   SECTION I - CONTRACT CLAUSES  33         PART III - LIST OF DOCUMENTS,
EXHIBITS AND OTHER ATTACHMENTS  39   SECTION J - LIST OF ATTACHMENTS  39     1.
Statement of Work  39     3. Invoice/Financing Request and Contract Financial
Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4  39
    4. Disclosure of Lobbying Activities, SF-LLL  39     5. Commitment To
Protect Non-Public Information  39     6. Roster of Employees Requiring
Suitability Investigations  39     7. Employee Separation Checklist  39        
PART IV - REPRESENTATIONS AND INSTRUCTIONS  40   SECTION K - REPRESENTATIONS AND
CERTIFICATIONS  40     1. Annual Representations and Certifications   40    
2. Annual Representations and Certifications, FAR Clause 52.204-8  40    
3. Animal Welfare Assurance Number  40

 
 
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Contract Number : HHSN272201300030C
 
PART I - THE SCHEDULE
 
SECTION B - SERVICES AND COSTS
 
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
 
NIAID's Division of Allergy, Immunology, and Transplantation funds applied and
translational research and development of radiation/nuclear medical
countermeasures (MCMs) to mitigate and/or treat radiation gastrointestinal
tissue damaged when administered at least 24 hours after radiation exposure.
OrbeShield will be evaluated as a MCM for Gastrointestinal-Acute Radiation
Syndrome (GI-ARS).
 
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 direct ratio to the level of effort expended; that is, the
percent of fee paid shall be equal to the percent of total effort expended.
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 [*****] .
       
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:

 
[img003.jpg]
 
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.
Indirect Costs

 

 
1.
In no event shall the final amount reimbursable for G&A costs exceed a ceiling
of indirect costs, and for Fringe costs exceed a ceiling of [*****] of [*****]
of salary costs. These rates shall be fixed for the life of the contract.
       
2.
The Government is not obligated to pay any additional amount should the final
indirect cost rates exceed these negotiated ceiling rates.
       
3.
The Contractor shall complete all work in accordance with the Statement of Work,
terms and conditions of this 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 Commission.
 
 
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Contract Number : HHSN272201300030C
 
  b.  Subcontract
 
To negotiate a [*****]                                                      type
subcontract with
[*****]                                                               for
non-human primate studies for an amount not to exceed $(as negotiated) for the
period 9/30/2013 through 9/29/2014. 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.
 
  c.  Consultants Consultant fees to be paid to the following individuals:
 
[img004.jpg]
 
  d.  Invoices - Cost and Personnel Reporting, and Variances from the Negotiated
Budget
 
1.  The Contractor agrees to provide a detailed breakdown on invoices of the
following cost categories:
 

 
a.
Direct Labor - List individuals by name, title/position, hourly/annual rate,
level of effort, and amount claimed.
       
b.
Fringe Benefits - Cite rate and amount
       
c.
Overhead - Cite rate and amount
       
d.
Materials & Supplies - Include detailed breakdown when total amount is over
$1,000.
       
e.
Travel - Identify travelers, dates, destination, purpose of trip, and amount.
Cite COA, if appropriate.
         
List separately, domestic travel, general scientific meeting travel, and foreign
travel.
     
f.
Consultant Fees - Identify individuals and amounts.
       
g.
Subcontracts - Attach subcontractor invoice(s).
       
h.
Equipment - Cite authorization and amount.
       
i.
G&A - Cite rate and amount.
       
j.
Total Cost
       
k.
Fixed Fee
       
l.
Total CPFF

 
Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government.
 
2. The Contractor agrees to immediately notify the Contracting Officer in
writing if there is an anticipated overrun (any amount) or unexpended balance
(greater than 10 percent) of the amount allotted to the contract, and the
reasons for the variance. Also refer to the requirements of the Limitation of
Funds and Limitation of Cost Clauses in 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 Commission.
 
 
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Contract Number : HHSN272201300030C
 
  e.   Confidential Treatment of Sensitive Information
 
The Contractor shall guarantee strict confidentiality of the information/data
that it is provided by the Government during the performance of the contract.
The Government has determined that the information/data that the Contractor will
be provided during the performance of the contract is of a sensitive nature.
 
Disclosure of the information/data, in whole or in part, by the Contractor can
only be made after the Contractor receives prior written approval from the
Contracting Officer. Whenever the Contractor is uncertain with regard to the
proper handling of information/data under the contract, the Contractor shall
obtain a written determination from the Contracting Officer.
 
  f.   Special Copyright Provisions
 
In accordance with FAR Clause 52.227-14, Rights in Data General, the Contractor
shall seek written permission from the Contracting Officer before establishing a
copyright for any software and associated data generated under this contract.
Additionally, the Government shall be provided a paid-up, world-wide,
irrevocable, nonexclusive license to all rights under any copyright obtained.
 
  g.  Contract Number Designation
 
On all correspondence submitted under this contract, the Contractor agrees to
clearly identify the contract number that appear on the face page of the
contract as follows:
 
Contract No. HHSN272201300030C
 
  h.  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.
 
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.    Acquisition, by purchase or lease, of any interest in real property;
 
4.    Special rearrangement or alteration of facilities;
 
 
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Contract Number : HHSN272201300030C

 
5.
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.);
       
6.
Travel to attend general scientific meetings;
       
7.
Foreign travel;
       
8.
Consultant costs;
       
9.
Subcontracts;
       
10.
Patient care costs;
       
11.
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.

 
  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 the negotiated amount 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.

 
 
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Contract Number : HHSN272201300030C
 
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
 
ARTICLE C.1. STATEMENT OF WORK
 
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 7/5/2013, set forth
in SECTION J-List of Attachments, attached hereto and made a part of this
contract.
 
ARTICLE C.2. REPORTING REQUIREMENTS
 
All reports required herein shall be submitted in electronic format. 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."
 
  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
in Attachment 2 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. Quarterly Progress Report
 
2. Annual Progress Report
 
3. Final Report
 
4. 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.
 
5.  Additional Reports and Deliverables
 
The Contractor shall submit the required reports as listed in Attachment 2,
Reporting Requirements and Deliverables
 
  b.  Other Reports/Deliverables
 
1.  Reporting of Financial Conflict of Interest (FCOI)
 
All reports and documentation required by 45 CFR Part 94, Responsible
Prospective Contractors including, but not limited to, the New FCOI Report,
Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be
submitted to the Contracting Officer in Electronic format. Thereafter, reports
shall be due in accordance with the regulatory compliance requirements in 45 CFR
Part 94.
 
45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?
c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&i  dno=45.
See Part 94.5, Management and reporting of financial conflicts of interest for
complete information on reporting requirements.
 
 
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Contract Number : HHSN272201300030C
 
(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING
INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this
contract.)
 
2. Source Code and Object Code
 
Unless otherwise specified herein, the Contractor shall deliver to the
Government, upon the expiration date of the contract, all source code and object
code developed, modified, and/or enhanced under this contract.
 
3.  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.
 
4.  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."
 
5.  Multiple Principal Investigators Leadership Plan
 
The Contractor shall submit a Leadership Plan in the event of a change in any of
the Principal Investigators named in the Key Personnel Article in SECTION G of
this contract. The revised plan is subject to review and approval by the
Contracting Officer.
 
  c.  Reports shall be sent to the following addresses as specified:
 
Deliver to
 
No. of Copies
Contracting Officer's Representative (COR)
 
One (1) Electronic Copy and One (1) Paper copy
Contracting Officer
 
One (1) Electronic Copy

 
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 first annual utilization report shall be due on or before October 31, 2014.
Thereafter, reports shall be due on or before the 30 Calendar day following the
reporting period. 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
    Office of Acquisitions
    6700B Rockledge Drive
    MSC 7612, Room 3214
    Bethesda, Maryland 20892- 7612
 
 
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Contract Number : HHSN272201300030C
 
 
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.
 
 
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Contract Number : HHSN272201300030C
 
SECTION D - PACKAGING, MARKING AND SHIPPING
 
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and Contractor name. The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.
 
 
 
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Contract Number : HHSN272201300030C
 
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 (COR)
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 Allergy,
Immunology, and Transplantation 6610 Rockledge Drive
   
Bethesda, MD 20892
         
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 52.246-9, Inspection of Research and Development (Short Form) (April
1984).
 
 
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Contract Number : HHSN272201300030C
 
SECTION F - DELIVERIES OR PERFORMANCE
 
ARTICLE F.1. PERIOD OF PERFORMANCE
 

 
a.
The period of performance of this contract shall be from 9/30/2013 through
9/29/2014.

 

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

 
Option
    Option Period
One
  9/30/2014 - 9/29/2015
Two
  9/30/2015 - 9/29/2016

 
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 described in Attachment 2 and
accordance with the stated delivery schedule:
 

 
a.
The items described in the REPORTING REQUIREMENTS Article in SECTION C of this
contract will be required to be delivered F.o.b. Destination as set forth in FAR
52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in
accordance with and by the dates specified in the delivery schedule and any
specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this
contract.

 

 
b.
The above items shall be addressed and delivered to:

 
       [*****]
Contracting Officer's Respresntative (COR)
DAIT, NIAID, NIH
6610 Rockledge Dr., [*****]
Bethesda, Maryland 20892 (for express mail:  [*****] )
 
Contracting Officer
OA/DEA/NIAID/NIH
6700B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892
 
ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
 
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. Also, the full text of a clause may
be accessed electronically at this
address: http://www.acquisition.gov/comp/far/index.html
 
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.
 
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 : HHSN272201300030C
 
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:
 
    [*****]
    Contracting Officer's Representative (COR)
    DAIT, NIAID, NIH
    6610 Rockledge Dr., Room[*****]
    Bethesda, MD 20892 (for express mail:     [*****])
    Phone: [*****]
    Fax: [*****]
    E-Mail: [*****]
 
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
 
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 individuals are considered to be essential to the work being
performed hereunder:
 
[img005.jpg]
 
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 : HHSN272201300030C
 
ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT
 
a.
Invoice/Financing Request Instructions and Contract Financial Reporting for NIH
Cost-Reimbursement Type Contracts NIH(RC)-4 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 paper copy of the invoice shall be submitted to the following approving
official:
             
Contracting Officer
     
Office of Acquisitions
     
National Institute of Allergy and Infectious Diseases, NIH
     
6700B Rockledge Drive, Room 3214
     
Bethesda, MD 20892 MSC 7612
             
E-Mail: NIAIDOAinvoices@niaid.nih.gov
             
The Contractor shall also submit an electronic copy of the payment request to
the approving official. 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 National Institute of Allergy and Infectious Diseases.
           
b)
Central Point of Distribution. For the purpose of this contract, the Central
Point of Distribution is
             
NIAIDOAinvoices@niaid.nih.gov
           
c )
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.
 
   
d)
DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and
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.

 
 
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Contract Number : HHSN272201300030C
 

     
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.
 
   
e)
Invoice Matching Option. This contract requires a two-way match.
           
f)
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.
           
g)
The Contract Title is:
   
    Development of Medical Countermeasures to Mitigate or Treat the
Gastrointestinal Acute Radiation Syndrome after a Nuclear or Radiation Incident
           
h)
Contract Line Items as follows:

 
[img006.jpg]
 
 
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."

 
ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS
 

 
a.
The Government encourages the contractor to pay small business subcontractors
along an accelerated timetable to the maximum extent practicable. The Government
recommends payment to small business subcontractors within 15 days of receipt of
proper documentation.

 

 
b.
Include the substance of this article, including this paragraph (b), in all
subcontracts with small business concerns.

 

 
c.
This policy does not modify the application or operation of the Prompt Payment
Act.

 
 
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Contract Number : HHSN272201300030C
 
ARTICLE G.5. 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
 
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. In addition to the Final
evaluation, Interim evaluation(s) will be prepared at least once during the
contract period of performance.
 
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 : HHSN272201300030C
 
SECTION H - SPECIAL CONTRACT REQUIREMENTS ARTICLE H.1. HUMAN SUBJECTS
 
It is hereby understood and agreed that research involving human subjects shall
not be conducted under this contract, and that no material developed, modified,
or delivered by or to the Government under this contract, or any subsequent
modification of such material, will be used by the Contractor or made available
by the Contractor for use by anyone other than the Government, for experimental
or therapeutic use involving humans without the prior written approval of the
Contracting Officer.
 
ARTICLE H.2. 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.3. 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.4. 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.5. 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.
 
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
 
ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
 
The Contractor shall not use contract funds to disseminate information that is
deliberately false or misleading.
 
 
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Contract Number : HHSN272201300030C
 
ARTICLE H.7. 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.

 

 
d.
If at any time during performance of this contract, the Contracting Officer
determines, in onsultation 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.8. 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), which is incorporated by reference.
 
ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS
 
No rodent or rodent product shall be delivered into the NIH, NIAID environment
(NIH) directly, or through collaborative research or holding facilities under
contract to NIAID except by permit. Direct shipments to NIH from a Division of
Veterinary Resources (DVR), Office of Research Services (ORS) approved source
will be considered exempt. Non- exempt sources must be approved by permit issued
through the DVR, ORS. The permit must be obtained by the Contractor prior to the
shipment to NIH of the rodents and/or rodent products. The Contractor must be
sure that this permit exists and is current before transferring rodents or
rodent products into the NIH, NIAID environment. Refusal or negligence to do so
will be considered a material breach of contract and may be treated as any other
such material breach. Applications for permits should be submitted by facsimile
not less than 30 days prior (60 days in situations where quarantine is likely)
to shipping date to: NIH Division of Veterinary Resources (DVR), Office of
Research Services (ORS), Building 14G, Service Rd. South, Room 102, BETHESDA MD
20892-5210, (301)496-2527, FAX: (301) 402-0352.
 
 
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Contract Number : HHSN272201300030C
 
 
ARTICLE H.10. 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.od.nih.gov/manualchapters/intramural/3044-2/
 
ARTICLE H.11. OPTION PROVISION
 
Unless the Government exercises its option pursuant to the Option Clause set
forth in ARTICLE I.3., 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
and FAR Clause 52.217-9, Option to Extend the Term of the Contract set forth in
ARTICLE I.3. 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 H.12. INFORMATION AND PHYSICAL ACCESS SECURITY
 
A. HHS-Controlled Facilities and Information Systems Security
 

 
a.
To perform the work specified herein, Contractor personnel are expected to have
routine (1) physical access to an HHS-controlled facility; (2) physical access
to an HHS-controlled information system; (3) access to sensitive HHS data or
information, whether in an HHS-controlled information system or in hard copy; or
(4) any combination of circumstances (1) through (3).

 

 
b.
To gain routine physical access to an HHS-controlled information system, and/or
access to sensitive data or information, the Contractor and its employees shall
comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a
Common Identification Standard for Federal Employees and Contractors; Office of
Management and Budget Memorandum (M-05­24); and Federal Information Processing
Standards Publication (FIPS PUB) Number 201; and with the personal identity
verification and investigations procedures contained in the following documents:

 

 
1.
HHS-OCIO Information Systems Security and Privacy Policy
( http://www.hhs.gov/ocio/policy/#Security)

 

 
2.
HHS HSPD-12 Policy Document, v. 2.0
(
http://www.whitehouse.gov/sites/default/files/omb/assets/omb/memoranda/fy2005/m05-24.pdf)

 

 
3.
Information regarding background checks/badges
( http://idbadge.nih.gov/background/index.asp)

 
 
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Contract Number : HHSN272201300030C
 

 
c.
Position Sensitivity Levels:
 
This contract will entail the following position sensitivity levels:
 
oLevel 6: Public Trust - High Risk. Contractor/subcontractor employees assigned
to Level 6 positions shall undergo a Suitability Determination and Background
Investigation (MBI).
 
oLevel 5: Public Trust - Moderate Risk. Contractor/subcontractor employees
assigned to Level 5 positions with no previous investigation and approval shall
undergo a Suitability Determination and a Minimum Background Investigation
(MBI), or a Limited Background Investigation (LBI).
 
x Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1
positions shall undergo a Suitability Determination and National Check and
Inquiry Investigation (NACI).

 

 
d.
The personnel investigation procedures for Contractor personnel require that the
Contractor prepare and submit background check/investigation forms based on the
type of investigation required. The minimum Government investigation for a
non-sensitive position is a National Agency Check and Inquiries (NACI) with
fingerprinting. More restricted positions - i.e., those above non-sensitive,
require more extensive documentation and investigation.
 
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 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 after the effective date of the contract. The
Contracting Officer shall notify the Contractor of the appropriate level of
suitability investigations to be performed. An electronic template, "Roster of
Employees Requiring Suitability Investigations," is available for contractor use
at: https://ocio.nih.gov/aboutus/publicinfosecurity/
acquisition/Documents/SuitabilityRoster 10-15-12.xlsx.
 
Upon receipt of the Government's notification of applicable Suitability
Investigations required, the Contractor shall complete and submit the required
forms within 30 days of the notification.
 
The Contractor shall notify the Contracting Officer in advance when any new
personnel, who are subject to a background check/investigation, will work under
the contract and if they have previously been the subject of national agency
checks or background investigations.
 
All contractor and subcontractor employees shall comply with the conditions
stablished for their designated position sensitivity level prior to performing
any work under this contract.
 
Contractors may begin work after the fingerprint check has been completed.

 

 
e.
Investigations are expensive and may delay performance, regardless of the
outcome of the investigation. Delays associated with rejections and consequent
re-investigations may not be excusable in accordance with the FAR clause,
Excusable Delays - see FAR 52.249-14. Accordingly, the Contractor shall ensure
that any additional employees whose names it submits for work under this
contract have a reasonable chance for approval.

 

 
f.
Typically, the Government investigates personnel at no cost to the Contractor.
However, multiple investigations for the same position may, at the Contracting
Officer's discretion, justify reduction(s) in the contract price of no more that
the cost of the additional investigation(s).

 

 
g.
The Contractor shall include language similar to this "HHS Controlled Facilities
and Information Systems Security" language in all subcontracts that require
subcontractor personnel to have the same frequency and duration of (1) physical
access to an HHS-controlled facility; (2) logical access to an HHS-controlled
information system; (3) access to sensitive HHS data/information, whether in an
HHS-controlled information system or in hard copy; or (4) any combination of
circumstances (1) through (3).

 
 
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Contract Number : HHSN272201300030C
 
 
h.
The Contractor shall direct inquiries, including requests for forms and
assistance, to the Contracting Officer or designee.

 
i.
Within 7 calendar days after the Government's final acceptance of the work under
this contract, or upon termination of the contract, the Contractor shall return
all identification badges to the Contracting Officer or designee.

 
B. 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.
               
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 contract award. 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.

 
 
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Contract Number : HHSN272201300030C
 
 

  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 800­26,
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 contract award. 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
contract award. The FIPS 199 Assessment shall be consistent with the cited NIST
standard. After resolution of any comments by the Government on the draft FIPS
199 Assessment, the Contracting Officer shall accept the FIPS 199 Assessment and
incorporate the Contractor's final version into the contract.

 

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

 

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

 

   
b)
The Contractor shall also perform an annual security control assessment and
provide to the Contracting Officer verification that the IT-SC&A remains valid.
Evidence of a valid system accreditation includes written results of:
 
     i. Annual testing of the system contingency plan; and
 
     ii. The performance of security control testing and evaluation.

 
 
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Contract Number : HHSN272201300030C
 

 
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).
 
 
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Contract Number : HHSN272201300030C
 
C. Additional NIH Requirements
 
1. SECURITY CATEGORIZATION OF FEDERAL INFORMATION AND INFORMATION SYSTEMS (FIPS
199 Assessment)
 
a. Information Type:
 
   o Administrative, Management and Support Information:
 
  x Mission Based Information:
 
b.  Security Categories and Levels:
 
Confidentiality Level:
x Low
o Moderate
o High
Integrity Level:
o Low
x Moderate
o High
Availability Level:
x Low
o Moderate
o High
       
Overall Level:
oLow
xModerate
oHigh

 
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.
 
 
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Contract Number : HHSN272201300030C
 
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.
 
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,
e­mail 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 COR prior to performing any
work under this acquisition.
 
 
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Contract Number : HHSN272201300030C
 
ARTICLE H.13. 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/sec508/standards.htm.

 
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:
   
    Submit with the Annual Technical Report.

 
[End of HHSAR 352.239-73(c)]
 
ARTICLE H.14. CONFIDENTIALITY OF INFORMATION
 
a.
Confidential information, as used in this article, means information or data of
a personal nature about an individual, or proprietary information or data
submitted by or pertaining to an institution or organization.

 
b.
The Contracting Officer and the Contractor may, by mutual consent, identify
elsewhere in this contract specific information and/or categories of information
which the Government will furnish to the Contractor or that the Contractor is
expected to generate which is confidential. Similarly, the
Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the
contract. Failure to agree will be settled pursuant to the "Disputes" clause.

 
 
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Contract Number : HHSN272201300030C
 
c.
If it is established elsewhere in this contract that information to be utilized
under this contract, or a portion thereof, is subject to the Privacy Act, the
Contractor will follow the rules and procedures of disclosure set forth in the
Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies,
with respect to systems of records determined to be subject to the Privacy Act.

 
d.
Confidential information, as defined in paragraph (a) of this article, shall not
be disclosed without the prior written consent of the individual, institution,
or organization.

 
e.
Whenever the Contractor is uncertain with regard to the proper handling of
material under the contract, or if the material in question is subject to the
Privacy Act or is confidential information subject to the provisions of this
article, the Contractor should obtain a written determination from the
Contracting Officer prior to any release, disclosure, dissemination, or
publication.

 
f.
Contracting Officer determinations will reflect the result of internal
coordination with appropriate program and legal officials.

 
g.
The provisions of paragraph (d) of this article shall not apply to conflicting
or overlapping provisions in other Federal, State or local laws.

 
The following information is covered by this article: TBD
 
ARTICLE H.15. INSTUTIONAL 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

 
 
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Contract Number : HHSN272201300030C
 
3.  Intellectual property rights and interests, upon receipt of income related
to such rights and interest. Significant financial interests do not include the
following:

 
a)
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

 
b)
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.

 
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".

 
 
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Contract Number : HHSN272201300030C
 
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.
 
ARTICLE H.16. 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 Allergy and Infectious Diseases, National Institutes of
Health, Department of Health and Human Services, under Contract No.
HHSN272201300021C"
 
ARTICLE H.17. 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 e-mail address is Htips@os.dhhs.gov and the mailing
address is:
 
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
 
 
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Contract Number : HHSN272201300030C
 
ARTICLE H.18. 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.19. SHARING RESEARCH DATA
 
The data sharing plan submitted by the Contractor is acceptable. 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.20. 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://www.usfa.fema.gov/hotel/index.htm.
 
ARTICLE H.21. 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.22. 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 : HHSN272201300030C
 
The following conferences and/or meetings have been approved by the Contracting
Officer and are hereby authorized under this contract:
 
[img007.jpg]
 
 
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Contract Number : HHSN272201300030C
 
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: https://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
 
Jan 2012
 
Definitions (Over the Simplified Acquisition Threshold)
52.203-3
 
Apr 1984
 
Gratuities (Over the Simplified Acquisition Threshold)
52.203-5
 
Apr 1984
 
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
 
Oct 2010
 
Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)
52.203-8
 
Jan 1997
 
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Over the Simplified Acquisition Threshold)
52.203-10
 
Jan 1997
 
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)
52.204-4
 
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)
52.215-15   Oct 2010   Pension Adjustments and Asset Reversions (Over $700,000)

 
 
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Contract Number : HHSN272201300030C
 

FAR        
CLAUSE NO.
 
DATE
 
TITLE
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
 
Jul 2013
 
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
 
Sep 2010
 
Equal Opportunity for Veterans ($100,000 or more)
52.222-36
 
Oct 2010
 
Affirmative Action for Workers with Disabilities
52.222-37
 
Sep 2010
 
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
 
Feb 2009
 
Buy American Act - 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
 
Dec 2007
 
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
 
Dec 2007
 
Rights in Data - General
52.232-9
 
Apr 1984
 
Limitation on Withholding of Payments
52.232-17
 
Oct 2010
 
Interest (Over the Simplified Acquisition Threshold)
52.232-20
 
Apr 1984
 
Limitation of Cost
52.232-23
 
Jan 1986
 
Assignment of Claims

 
 
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Contract Number : HHSN272201300030C
 

FAR        
CLAUSE NO.
 
DATE
 
TITLE
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
 
Jul 2002
 
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 2001
 
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 2013
 
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. 08/2013].
 
 
 
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Contract Number : HHSN272201300030C
 
ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES
 
ARTICLE I.1. of this SECTION is hereby modified as follows:
 
a.
FAR Clauses 52.215-15, Pension Adjustments and Asset Reversions (October 2010);
52.215-18, Reversion or Adjustment of Plans for Post Retirement Benefits (PRB)
Other Than Pensions (July 2005); and, 52.215-19, Notification of Ownership
Changes (October 1997), are deleted in their entirety.

 
b.
Alternate IV (October 2010) of FAR Clause 52.215-21, Requirements for Certified
Cost or Pricing Data and Data Other Than Certified Cost or Pricing
Data—Modifications (October 2010) 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:
 
[img008.jpg]
 
3. FAR Clause 52.210-1, Market Research (April 2011).
 
4. FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October
1997).
 
5. 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 30 days.
 
6.
FAR Clause 52.219-4, Notice of Price Evaluation Preference for HUBZone Small
Business Concerns (January 2011).

 
"(c) Waiver of evaluation preference
 
oOfferor elects to waive the evaluation preference."
 
7.
FAR Clause 52.219-25, Small Disadvantaged Business Participation Program—
Disadvantaged Status and Reporting (December 2010).

 
8.
FAR Clause 52.219-28, Post-Award Small Business Program Rerepresentation (April
2012).

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

 
10.
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: TBD

 
 
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Contract Number : HHSN272201300030C
 
11.
FAR Clause 52.227-16, Additional Data Requirements (June 1987).

 
12.
FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2001).

 
13.
FAR Clause 52.247-64, Preference for Privately Owned U.S. Flag Commercial
Vessels (February 2006).

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

 
1.
HHSAR Clause 352.231-70, Salary Rate Limitation (August 2012).
 
Note:  P.L. 112-74 sets forth the Salary Rate Limitation at the Executive Level
II Rate, effective December 23, 2011. See the following Web site 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.)

 
2.
HHSAR Clause 352.233-70, Choice of Law (Overseas) (October 2009).

 
3.
HHSAR Clause 352.270-1, Accessibility of Meetings, Conferences and Seminars to
Persons with Disabilities (January 2001).

 
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 (February 2012)
 
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 Central
Contractor Registration database at https://www.acquisition.gov.

 
b)
As required by section 3010 of the Supplemental Appropriations Act, 2010 (Pub.
L. 111­212), 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;
 
 
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Contract Number : HHSN272201300030C
 
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
non­public 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.

 
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)
 
2. FAR Clause 52.217-9, Option to Extend the Term of the Contract (March 2000).
 
a.
The Government may extend the term of this contract by written notice to the
Contractor within 30 days; provided that the Government gives the Contractor a
preliminary written notice of its intent to extend at least 30 days before the
contract expires. The preliminary notice does not commit the Government to an
extension.

 
b.
If the Government exercises this option, the extended contract shall be
considered to include this option clause.

 
c.
The total duration of this contract, including the exercise of any options under
this clause, shall not exceed 3 YEARS.

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

 
THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.
 
 
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Contract Number : HHSN272201300030C
 
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, dated 7/5/2013, 6 pages.
 
2.Delivery Schedule, Reporting Requirements and Deliverables
 
3. Invoice/Financing Request and Contract Financial Reporting Instructions for
NIH Cost- Reimbursement Type Contracts, NIH(RC)-4, (8/12), 6 pages.
 
4. Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages.
 
5. Commitment To Protect Non-Public Information, 1 page. Located at:
https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf
 
6. 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
 
7.Employee Separation Checklist, 1 page. Fillable PDF format located at:
https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf
 
 
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Contract Number : HHSN272201300030C
 
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 completed and located in the Online
Representations and Certifications Application (ORCA) at The System for
Acquisition Mangement (SAM) website ( http:// www.sam.gov). [This includes the
changes identified in paragraph (b) of the FAR provision 52.204-8, Annual
Representations and Certifications, contained in the Contractor's proposal.]

 
2.
NIH Representations & Certifications, dated 11/21/2010

 
5.
Animal Welfare Assurance Number for[*****]

 
END of the SCHEDULE
 
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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