Exhibit 10.7


 


  




     
 


     


    

 


Contract Number : HHSN261201400013C



 


CONTRACT
TABLE OF CONTENTS


 





	PART I - THE SCHEDULE	4
	SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS	4
	ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	4
	ARTICLE B.2. PRICES	4
	ARTICLE B.3. OPTION FOR PHASE II	5
	ARTICLE B.4. ADVANCE UNDERSTANDINGS	5
	ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS	7
	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	15
	SECTION D - PACKAGING, MARKING AND SHIPPING	15
	SECTION E - INSPECTION AND ACCEPTANCE	15
	SECTION F - DELIVERIES OR PERFORMANCE	16
	ARTICLE F.1. PERIOD OF PERFORMANCE	16
	ARTICLE F.2. DELIVERIES	16
	ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)	18
	SECTION G - CONTRACT ADMINISTRATION DATA	18
	ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)	18
	ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)	18
	ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT	19
	ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)	21
	ARTICLE G.5. GOVERNMENT PROPERTY	21
	ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	22
	SECTION H - SPECIAL CONTRACT REQUIREMENTS	22
	ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)	22
	ARTICLE H.2. HUMAN SUBJECTS	23
	ARTICLE H.3. RESTRICTION ON USE OF HUMAN SUBJECTS, HHSAR 352.270-6 (January 2006)	23
	ARTICLE H.4. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS	23
	ARTICLE H.5. DATA AND SAFETY MONITORING IN CLINICAL TRIALS	24
	ARTICLE H.6. REGISTRATION AND RESULTS REPORTING FOR APPLICABLE CLINICAL TRIALS IN CLINICALTRIALS.GOV	24
	ARTICLE H.7. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH	24
	ARTICLE H.8. NEEDLE DISTRIBUTION	25
	ARTICLE H.9. ACKNOWLEDGEMENT OF FEDERAL FUNDING	25
	ARTICLE H.10. RESTRICTION ON ABORTIONS	25
	ARTICLE H. 11. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH	25
	ARTICLE H.12. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION	25
	ARTICLE H.13. PRIVACY ACT, HHSAR 352.224-70 (January 2006)	25







 




    	 	- 2 -	 



     


    

 


Contract Number : HHSN261201400013C


 





	ARTICLE H.14. OMB CLEARANCE	26
	ARTICLE H.18. OPTION PROVISION	26
	ARTICLE H.19. LIMITATIONS ON SUBCONTRACTING - SBIR	26
	ARTICLE H.20. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010)	27
	ARTICLE H.21. CONFIDENTIALITY OF INFORMATION	27
	ARTICLE H.22. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST - PHASE II	28
	ARTICLE H.23. PUBLICATION AND PUBLICITY	30
	ARTICLE H.24. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	30
	ARTICLE H.25. YEAR 2000 COMPLIANCE	31
	ARTICLE H.26. USE OF FUNDS FOR PROMOTIONAL ITEMS	31
	PART II - CONTRACT CLAUSES	32
	SECTION I - CONTRACT CLAUSES	32
	PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS	40
	SECTION J - LIST OF ATTACHMENTS	40
	1. Statement of Work	40
	2. Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2	40
	3. Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts, NIH(RC)-4	40
	4. Cumulative Inclusion Enrollment Report	40
	5. Privacy Act System of Records, Number	40
	6. Research Patient Care Costs	40
	7. Disclosure of Lobbying Activities, SF-LLL	40
	8. Government Property - Schedule IB	40
	9. Report of Government Owned, Contractor Held Property	40
	PART IV - REPRESENTATIONS AND INSTRUCTIONS	42
	SECTION K - REPRESENTATIONS AND CERTIFICATIONS	42
	1. Annual Representations and Certifications	42
	2. Annual Representations and Certifications, FAR Clause 52.204-8	42
	3. Human Subjects Assurance Identification Number	42







 




    	 	- 3 -	 



     


    

 


Contract Number : HHSN261201400013C


 


PART
I- THE SCHEDULE


 


SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS


 


ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES


 


Phase
I: To advance commercialization efforts for IPdR (5-iodo-2-pyrimidinone-2'-deoxyribose), a prodrug of the radiosensitizer IUdR
(5-iodo-2'-deoxyuridine). The Phase I will determine the scientific merit, feasibility and potential for commercialization of oral
IPdR as a radiation sensitizer for use in cancer treatment. Administrative tasks will be completed to enable an IND for the Contractor;
formulation of GMP manufactured IPdR into 250 mg capsules; submission of a letter of intent (LOI) to CTEP; protocol preparation
and IRB approval for the proposed Phase I clinical trial and establishment of companion diagnostics for analyzing clinical specimens
from Phase I patients.


 Phase
II: To perform the first-in-human therapeutic trial assessing safety and pharmacokinetics of 5-iodo-2- pyrimidinone-2'-deoxyribose
(IPdR), as a radiosensitizer for cancer treatment. The Phase I clinical trial and PK study will be performed as the first step
in the plan to commercialize IPdR.


 


ARTICLE B.2. PRICES


 


		a.	The total fixed price of this contract is $191,971.



 


		b.	Upon delivery and acceptance of the item specified in the DELIVERY Article in SECTION F and described
in SECTION C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit
prices set forth below:



 


PAYMENT
SCHEDULE  




 





	Description	 	Invoice #	 	Period Covered	 	Amount	 
	PDF Kick-Off
    Presentation	 	HHSN261201400013C
    - 01	 	Month 1	 	$	47,993	 
	Quarterly
    Report 1	 	HHSN261201400013C -
    02	 	Month 2-3	 	$	47,993	 
	Quarterly
    Report 2	 	HHSN261201400013C -
    03	 	Month 4-6	 	$	47,993	 
	Draft
    Commercialization Plan, Draft Final Report	 	HHSN261201400013C -
    04	 	Start
    date of contract through one month prior to contract completion date	 	$	23,996	 
	PDF
    of Final Presentation, Final Report, Summary of Salient Results, Final Commercialization Plan	 	HHSN261201400013C -
    05	 	Entire Contract Period
    of Performance	 	$	23,996	 
	TOTAL FIXED PRICE	 	 	 	 	 	$	191,971	 





 







    	 	- 4 -	 



     


    

 


Contract Number : HHSN261201400013C


 


ARTICLE
B.3. OPTION FOR PHASE II


 


		a.	The fixed price of the Base Period (Phase I) of this contract
is $191,971.



 


		b.	If the Government exercises its option pursuant to the
OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum
of the estimated cost plus the fixed fee will be increased as follows:



 


	 	 	Estimated Cost

    ($)	 	 	Fixed Fee

    ($)	 	 	Estimated Cost

    Plus Fixed Fee 

    ($)	 
	Base Period 9/19/2014 - 6/18/2015	 	$	181,105	 	 	$	10,866	 	 	$	191,971	 
	Option Period: 6/19/2015 - 6/18/2017	 	$	1,347,280	 	 	$	80,837	 	 	$	1,428,117	 
	Total	 	$	1,528,385	 	 	$	91,703	 	 	$	1,620,088	 
	[Base Period and Option]	 	 	 	 	 	 	 	 	 	 	 	 



 


ARTICLE B.4. 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 indirect
costs exceed ceiling rates of 15% of Direct Labor for Fringe Benefits, 30% of Direct Labor for Overhead, and 12% of Direct Labor
for G&A.



 


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



 


Any
costs over and above this cost ceiling shall not be reimbursed under this contract or any other Government contract, grant, or
cooperative agreement.


 


		3.	The Contractor shall complete all work in accordance with the Statement of Work, terms and conditions
of this contract.



 


		b.	Subcontract



 


To
negotiate a fixed price type subcontract with with
Rhode Island Hospital for Phase I for an amount not to exceed $65.549
for the period 9/19/2014-6/18/2015
.. 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.


 


If
the Government exercises its option for Phase II pursuant to the Option Provision Article in Section H of this contract, the total
estimated Subcontract amount will be increased as follows:


 


Option
- 6/19/2015-6/18/2017 - $623,269


 




    	 	- 5 -	 



     


    

 


Contract Number : HHSN261201400013C


 


Consultant


 


c.  Consultants
Consultant fee(s) to be paid to the following individual(s): Phase II only


 


	Name	 	Rate 
 Per
    Hour	 	 	Number of Hours	 	 	Total Cost 

    Including Travel 

    Not to Exceed	 
	Carl Schmidt,	 	$	200	 	 	 	100	 	 	$	20,000	 
	Commercialization	 	 	 	 	 	 	 	 	 	 	 	 
	Consultant, Phase II	 	 	 	 	 	 	 	 	 	 	 	 



 


d.  Scientific Meetings


 


		a.	Travel to general scientific meetings shall be unallowable without the prior written approval of the Contracting Officer. No
retroactive approvals will be issued, and no travel costs incurred without prior Contracting Officer approval will be paid.



 


		b.	All travel requests shall be sent to both the Contracting Officer and the Contracting Officer's Representative (COR) 90 calendar
days prior to the planned start date of the travel. If it is determined that the travel is allowable, then the Contracting Officer
will issue written approval.



 


e.  Contract Number Designation


 


On
all correspondence submitted under this contract, the Contractor agrees to clearly identify the two contract numbers that appear
on the face page of the contract as follows:


 


Contract
No. HHSN261201400013C


NCI Control No. N01CO-2014-00013 .


 


f.  SBIR Funding Agreement Certification


 


The
SBIR Funding Agreement Certification form, located in SECTION J, must be completed at the time of award prior to the performance
of work under this contract, in accordance with the SBIR Policy Directive issued by SBA (October 18, 2012).


 


For
additional information, see NIH Policy Notice NOT-OD-13-116, entitled, "New Program Certifications Required for SBIR and
STTR Awards," located at: http://grants.nih.gov/grants/guide/notice-files/NOT- OD-13-116.html .


 


g.  SBIR Fast Track Recertification Requirement


 


Phase
I and Phase II SBIR awards are considered separate funding agreements under the Fast-Track Initiative. Therefore, Phase I Fast-Track
awardees must recertify that they meet all of the eligibility criteria for an SBIR or STTR award prior to issuance of the Phase
II award.


 


h.Software Purchases


 


All
software purchases must first be approved in writing by the Contracting Officer.


 




    	 	- 6 -	 



     


    

 


Contract Number : HHSN261201400013C


 


ARTICLE B.5. PROVISONS APPLICABLE TO DIRECT COSTS


 


     a.Items
Unallowable Unless Otherwise Provided


 


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


 


		1.	Conferences and Meetings



 


		2.	Food for Meals, Light Refreshments, and Beverages



 


		3.	Promotional
                                         Items [includes, but is not limited to: clothing and commemorative items
                                         such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are sometimes
                                         provided to visitors, employees, grantees, or conference attendees.]



 


		4.	Acquisition, by purchase or lease, of any interest in real property;



 


		5.	Special rearrangement or alteration of facilities;



 


		6.	Purchase or lease of any
item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment
is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings,
pocket calculators, etc.);



 


		7.	Travel to attend general scientific meetings;



 


		8.	Foreign travel;



 


		9.	Consultant costs;



 


		10.	Subcontracts;



 


		11.	Patient care costs;



 


		12.	Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more and
"sensitive items" (defined as items of personal property (supplies and equipment that are highly desirable and easily
converted to person use), regardless of acquisition value.



 


		13.	Printing Costs (as defined in the Government Printing and Binding Regulations).



 




    	 	- 7 -	 



     


    

 


Contract Number : HHSN261201400013C


 


   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 $9,600 in Phase II without the prior written approval of the Contracting Officer.


 


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



 


SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT


 


ARTICLE C.1. STATEMENT OF WORK


 


		a.	Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform
the Statement of Work, set forth in SECTION J-List of Attachments, attached hereto and made a part of this contract.



 


	Document
    Title	 	Date
	Statement of Work - Phase I	 	August 25, 2014
	Statement of Work - Phase II	 	August 25, 2014


 


		b.	Privacy Act System of Records Number 09-25-0200 is applicable
to this contract and shall be used in any design, development, or operation work to be performed under the resultant contract.
Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative
(COR).



 


ARTICLE C.2. REPORTING REQUIREMENTS


 


All
reports required herein shall be submitted in an electronic format via email as attachments to the following designated NCI Branch
Distribution Mailbox.: Ncibranchbinvoices@mail.nih.gov


 


Each
email submission shall contain only one deliverable, if the attached file for the deliverable exceeds 50 MB, the Contractor
shall divide the deliverable into files of 50 MB each. All deliverables shall be limited to five file attachments or
less.


 


The
subject line of the email shall read as follows:


 


Deliverable_Contract
Number_Vendor's Name_Deliverable Description_Due Date


 


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.”


 




    	 	- 8 -	 



     


    

 


Contract Number : HHSN261201400013C


 


   a.
Technical Reports


 


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


 


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


 


1.Kick-off Presentation


 


The
Contractor shall prepare and submit a kick-off presentation. Presentation of the slides will occur either in-person, through Webinar,
or teleconference. The presentation shall cover the following:


 


		a.	Discussion of the Contractor's organization/project status, particularly changes that occurred since the proposal submission.



 


		b.	The Contractor's recent achievements (patents, publications, sales, regulatory approvals, partnerships, awards, etc.).



 


		c.	Status of the field.



 


		d.	Status of commercial and academic competitors.



 


		e.	Where is the proposed project positioned against the state
of the art.



 


		f.	Intellectual property landscape.



 


		g.	Refresher on the proposed technology/ R&D.



 


		h.	Detailed plan for the first budget period of the contract.



 


		i.	Milestones (technical and commercial) to be achieved by
the end of the first budget period of the contract.



 


		j.	Discussion of anticipated technical risks and alternative
approaches.



 


		k.	Questions to the NCI



 


2.Quarterly Report


 


Phase
I


 


The
Contractor shall submit two (2) Quarterly Reports which shall include:


 


		a.	Summary of technical objectives with status of each objective clearly marked (e.g. previously complete, complete during the
reporting period, not started, etc.).



 


		b.	Clear description of activities accomplished in the quarter.



 


		c.	Analysis of experimental data and presentation of selected
data.



 


		d.	Comments regarding the timeliness of performance.



 


		e.	Brief explanation of objectives/activities to be pursued
in the next reporting period.



 


The
report shall generally be no longer than five (5) pages excluding tables presenting the data, figures, images, and graphs.


 




    	 	- 9 -	 



     


    

 


Contract Number : HHSN261201400013C


 


Phase II


 


The Contractor
shall submit Quarterly Reports which shall include the same information as required for the Phase I Quarterly Reports. The first
reporting period in Phase II consists of the first full three (3) months of performance including any fractional part of the initial
month. Thereafter, the reporting period shall consist of three (3) full calendar months.


 


The first Phase
II Quarterly Report shall be due 15 calendar days after the first complete reporting period. Thereafter, report shall be due on
or before the 15th calendar day following each reporting period.


 


3.Draft Updated Commercialization Plan


 


The
Contractor shall submit an updated commercialization plan which shall include:


 


a.Value
of the SBIR Project. Expected Outcomes, and Impact


 


Describe,
in layperson's terms, the proposed project and its key technology objectives. State the product, process, or service to be developed
in Phase III. Clarify the need addressed, specifying weaknesses in the current approaches to meet this need. In addition, describe
the commercial applications of the research and the innovation inherent in this application. Be sure to also specify the potential
societal, educational, and scientific benefits of this work. Explain the non-commercial impacts to the overall significance of
the project. Explain how the SBIR contract integrates with the overall business plan of the company.


 


b.Organization


 


Give
a brief description of the Contractor's organization including corporate objectives, core competencies, present size (annual sales
level and number and types of employees), history of previous Federal and non-Federal funding, regulatory experience, and subsequent
commercialization, and any current products/services that have significant sales. Include a short description of the origins of
the Contractor's organization. Indicate the Contractor's vision for the future, how the Contractor will grow/maintain a sustainable
business entity, and how the Contractor will meet critical management functions as the Contractor's organization evolves from a
small technology R&D business to a successful commercial entity.


 


c.Market,
Customer, and Competition


 


Describe
the market and/or market segments being targeted and provide a brief profile of the potential customer. Tell what significant advantages
the Contractor's innovation will bring to the market, e.g., better performance, lower cost, faster, more efficient or effective,
new capability. Explain the hurdles the Contractor will have to overcome in order to gain market/customer acceptance of the Contractor's
innovation. Describe any strategic alliances, partnerships, or licensing agreements the Contractor has in place to get FDA approval
(if required) and to market and sell the Contractor's product. Briefly describe the Contractor's marketing and sales strategy.
Give an overview of the current competitive landscape and any potential competitors over the next several years.


 


d.Intellectual
Property (IP) Protection


 


Describe
how the Contractor is going to protect the IP that results from the Contractor's innovation. Also note other actions the Contractor
may consider taking that will constitute at least a temporal barrier to others aiming to provide a solution similar to the Contractor's.


 




    	 	- 10 -	 



     


    

 


Contract Number : HHSN261201400013C


 


e.Finance
Plan


 


Describe
the necessary financing the Contractor will require to commercialize the product, process, or service, and when it will be required.
Describe the Contractor's plans to raise the requisite financing to launch the Contractor's innovation into Phase III and begin
the revenue stream. Plans for this financing stage may be demonstrated in one or more of the following ways:


 


		·	Letter of commitment of funding.



 


		·	Letter of intent or evidence of negotiations to provide
funding, should the Phase II project be successful and the market need still exist.



 


		·	Letter of support for the project and/or some in-kind commitment,
e.g., to test or evaluate the innovation.



 


		·	Specific steps the Contractor is going to take to secure
Phase III funding.



 


f.Production
and Marketing Plan


 


Describe
how the production of the Contractor's product/process/service will occur (e.g., in-house manufacturing, contract manufacturing).
Describe the steps the Contractor will take to market and sell the Contractor's product/process/service. For example, explain plans
for licensing, Internet sales, etc.


 


g.Revenue
Stream


 


Explain
how the Contractor plans to generate a revenue stream for the Contractor's organization should this project be a success. Examples
of revenue stream generation include, but are not limited to; manufacture and direct sales, sales through value added resellers
or other distributors, joint venture, licensing, service. Describe how the Contractor's staffing will change to meet the Contractor's
revenue expectations.


 


The
Draft Updated Commercialization Plan shall be submitted one (1) month before the the Phase I completion date. The Contracting Officer's
Representative (COR) will provide comments regarding the Draft Updated Commercialization Plan within two (2) weeks from the receipt
date of the document.


 


		4.	Draft Final Report and Draft Summary of Salient Results



 


Phase
I


 


The
Draft Final Report for Phase I shall consist of the work performed and results obtained for the entire contract period of performance
of Phase I as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the results
achieved.


 


The
Draft Summary of Salient Results for Phase I shall be consist of a summary (not to exceed 200 words) of salient results achieved
during the performance of the contract.


 


Both
the Draft Final Report and Draft Summary of Salient Results for Phase I shall be submitted one (1) month before the the Phase I
completion date. A Quarterly Report shall not be required for the period when the Phase I Final Report is due. The COR will provide
comments regarding the Draft Final Report and Draft Summary of Salient Results for Phase I within two (2) weeks from the receipt
date of the document.


 




    	 	- 11 -	 



     


    

 


Contract Number : HHSN261201400013C


 


Phase
II


 


The
Draft Final Report for Phase II shall consist of the work performed and results obtained for the entire contract period of performance
of Phase II as stated in SECTION F of this contract. This report shall be in sufficient detail to describe comprehensively the
results achieved.


 


The
Draft Summary of Salient Results for Phase II shall consist of a summary (not to exceed 200 words) of salient results achieved
during the performance of the contract.


 


Both
the Draft Final Report and Draft Summary of Salient Results for Phase II shall be submitted one (1) month before the Phase II contract
completion date. A Quarterly Report shall not be required for the period when the Phase II Final Report is due. The COR will provide
comments regarding the Draft Final Report and Draft Summary of Salient Results for Phase II within two (2) weeks from the receipt
date of the document.


 


5. Final Commercialization Plan


 


The
Contractor shall provide the Final Commercialization Plan by the completion date of the Phase I portion of the contract. This document
shall include the changes required in the Draft Updated Commercialization Plan as well as the comments provided by the COR.


 


6.Final Report


 


Phase
I


 


The
Contractor shall provide the Phase I Final Report by the completion date of the Phase I portion of the contract. This document
shall include the changes required in the Phase I Draft Final Report as well as the comments provided by the COR.


 


Phase II


 


The
Contractor shall provide the Phase II Final Report by the completion date of the Phase II portion of the contract. This document
shall include the changes required in the Phase II Draft Final Report as well as the comments provided by the COR.


 


7.Final Presentation


 


Phase
I


 


The
Contractor shall prepare and submit a final presentation which shall be due on or before the completion date of Phase I portion
of the contract. Presentation of the slides shall occur either in-person, through Webinar, or teleconference. The presentation
shall cover the following:


 


		a.	Discussion of the Contractor's organization/project status.



 


		b.	The Contractor's achievements during the Phase I performance period (patents, publications, sales, regulatory approvals, partnerships,
awards, etc.)



 


		c.	Detailed results of the performed research and development.



 


		d.	Discussion of proposed milestones and whether they were achieved during the contract performance.



 


		e.	Summary of submitted commercialization plan.



 


		f.	If the Contractor is interested in pursuing Phase II research, detailed discussion of the anticipated
Phase II technical activities with emphasis on how they fit in the commercialization plan. The Phase II research plan and commercialization
plan shall be included in the final presentation for Phase I.



 


		g.	Questions to the NCI.



 




    	 	- 12 -	 



     


    

 


Contract Number : HHSN261201400013C


 


Phase II


 


The
Contractor shall prepare and submit a final presentation which shall be due on or before the completion date of Phase II portion
of the contract. Presentation of the slides shall occur either in-person, through webinar, or teleconference. The presentation
shall cover the following:


 


		a.	Discussion of the Contractor's/project status.



 


		b.	The Contractor's achievements during the performance period (patents, publications, sales, regulatory approvals, partnerships,
awards, etc.).



 


		c.	Detailed technical results of the performed research and
development.



 


		d.	Discussion of proposed milestones and whether they were
achieved during the contract performance.



 


		e.	Summary of progress towards commercialization.



 


		f.	Questions to the NCI.



 


8.Final Summary of Salient Results


 


Phase
I 


 


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


 


Phase II


 


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


 


9.Annual Technical Progress Report for Clinical
Research Study Populations


 


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


 


The
Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.


 


In
addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October,
2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the
following website:


 


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


 


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


 




    	 	- 13 -	 



     


    

 


Contract Number : HHSN261201400013C


 


b.Other Reports/Deliverables


 


1.Reporting of Financial Conflict of Interest
(FCOI) - Phase II


 


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.aov/cai-bin/text-idx?


c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45. See Part 94.5, Management and reporting of financial conflicts of interest for complete information on
reporting requirements.


 


(Reference
subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H
of this contract.)


 


2.Section 508 Annual Report


 


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


 


3.NIH Small Business Innovation Research (SBIR)
Program Life Cycle Certification


 


In
accordance with the SBIR/STTR Reauthorization Act of 2011, the Contractor shall complete and submit the NIH Small Business Innovation
Research (SBIR) Life Cycle Certification form, located in SECTION J of the contract, to the Contracting Officer. This certification
is required to ensure the Contractor is meeting the program's requirements during the life cycle of the contract.


 


The
Life Cycle Certification form shall be submitted as follows:


 


		·	Phase I SBIR Contractors shall submit the Certification
at the time of receiving final payment or disbursement.



 


		·	Phase II SBIR Contractors shall submit the Certification
prior to receiving more than 50% of the total contract amount AND
prior to final payment or disbursement.



 


The
Contracting Officer, may, at any time after award request further clarifications and supporting documentation in order to assist
in the verification of any information provided by the Contractor.


 


For
additional information, see NIH Policy Notice NOT-OD-13-116, entitled, "New Program Certifications Required for SBIR and
STTR Awards," located at: http://grants.nih.gov/grants/guide/ notice-files/NOT-OD-13-116.html.


 




    	 	- 14 -	 



     


    

 


Contract Number : HHSN261201400013C


 


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 completion date of the contract.


 


All
reports shall be submitted in accordance with the DELIVERIES Article in SECTION F


 


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 email address specified in SECTION F.


 


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


 


SECTION D - PACKAGING, MARKING AND SHIPPING


 


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


 


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
Cancer Institute


  9609
Medical Center Drive, Room 1W542, MSC 9706 Bethesda, MD 20892-9706


 


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).


 


  FAR
Clause 52.246-16, Responsibility for Supplies (April
1984).


 




    	 	- 15 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


SECTION F - DELIVERIES OR PERFORMANCE


 


ARTICLE F.1. PERIOD OF PERFORMANCE


 


		a.	The period of performance of this contract shall be from 09/19/2014 through 06/18/2015.



 


		b.	If the Government exercises its option 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
	 	 	 
	Option for Phase II	 	June 19, 2015 - June 18, 2017



  


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 following items in accordance with the stated delivery schedule:


 


		a.	The items specified below as 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 below:



 





	Item

        No.
	 	Description	 	Delivery
    Schedule
	1.	 	SBIR Funding Agreement
    Certification	 	At time of award,
    prior to the performance of any work under this contract.
	2.	 	Kick Off Presentation	 	Due at the conclusion
    of the Kick- Off presentation which shall be completed within 30 calendar days of contract award.
	3.	 	Quarterly Report One
    - Phase 1	 	Due within 15 calendar
    days of completion of month 3 of performance.
	4.	 	Quarterly Report Two
    - Phase 1	 	Due within 15 calendar
    days of completion of month 6 of performance.
	5.	 	Draft Updated Commercialization Plan,

        Draft Summary of Salient Results, and Draft Final
        Report and Draft Final Report - Phase 1
	 	Due
    one (1) month before the Phase I completion date.
	6.	 	Final Presentation,
    Final Summary of Salient Results, Final Report and Final Presentation - Phase 1	 	Due on or before Phase I completion date.
	7.	 	Quarterly Reports
    - Phase II	 	Within 15 calendar
    days after each reporting period.
	8.	 	Draft Summary of Salient
    Results, and Draft Final Report and Draft Final Report - Phase II	 	One month prior to
    the Phase II completion date.
	9.	 	Final Summary of Salient
    Results, Final Report and Final Presentation - Phase II	 	Due on or before the
    Phase II completion date.
	10.	 	Final Presentation-
    Phase II	 	Due on or before the completion of Phase II.




 




    	 	- 16 -	 



     


    

 


Contract
Number : HHSN261201400013C


 





	Item

        No.
	 	Description	 	Delivery
    Schedule
	11.	 	Annual Technical Progress
    Report for Clinical Research Study Population (Cumulative Inclusion Enrollment Report) - Phase II	 	Due one year after
    the start of Phase II.
	12.	 	Protection of Human Subjects Assurance Identification/I
    RB Certification/Declaration of Exemption", Form OMB No. 0990-0263	 	Prior to starting
    any work involving human subjects.
	13.	 	Annual Utilization
    Report	 	Due one year after
    the start of Phase II.
	14.	 	Final Invention Statement	 	Due on or before contract
    completion date.
	15.	 	Invention Disclosure
    Report	 	Due on or before contract
    completion date.
	16.	 	Section 508 Annual
    Report	 	Due one year after
    the start of Phase II.
	17.	 	Section 508 Conformance
    Certification	 	Due on or before Phase
    I completion date.
	18.	 	New or Revised Financial Conflict of Interest
    (FCOI) Report and Mitigation Report	 	Due as FCOI arises.
	19.	 	SBIR Program Life
    Cycle Certification - Phase 1	 	Due on or before Phase
    I completion date.
	20.	 	SBIR Program Life
    Cycle Certification - Phase II - Report 1	 	Due prior to receiving
    50% of the total contract amount.
	21.	 	SBIR Program Life
    Cycle Certification - Phase II - Report 2	 	Due on or before Phase II completion date.




 


 


		b.	The above items
                                         shall be addressed and emailed to ncibranchbinvoices@mail.nih.gov. The following
                                         addresses are provided for general correspondence and other deliveries:



 





	Addressee	 	Deliverable Item No	 	Quantity
	
        Andrea Giuliano, Contract Specialist

        National Cancer Institute

        Office of Acquisitions, Room 1E148

        9609 Medical Center Drive, MSC

        9705

        Bethesda, MD 20892-9705
	 	1-14, 16-21	 	Electronically
	
        Deepa Narayanan, COR

        National Cancer Institute

        NCI SBIR & STTR Programs, Room

        1W542

        9609 Medical Center Drive, MSC

        9705

        Bethesda, MD 20892-9705
	 	2-12	 	Electronically
	OPERA, OEH, NIH

6705 Rockledge Drive

Suite 310, MSC 7980 

Bethesda, Maryland 20892-7980	 	13-15	 	1 Hard Copy




 




    	 	- 17 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


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


 


This
contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon
request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically
at this address: http://www.acquisition.gov/far.


 


FEDERAL
ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:


 


52.242-15,Stop
Work Order (August 1989) (Applicable to Phase I)


 


52.242-15,Stop
WorkOrder, Alternate I (April 1984) is applicable to Phase II of this contract.


 


52.242-17,Government
Delay of Work (April
1984).


 


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:


 


Deepa
Narayanan, Ph.D.


 


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)


 




    	 	- 18 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


The following individual is considered to be essential to the work being performed hereunder:  


 





	Name 	 	 Title 
	Theodore L. Phillips, M.D.	 	  Principal Investigator








 


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


 


		a.	Invoice Instructions for NIH
Fixed-Price Type Contracts, NIH(RC)-2 (Phase I) and Invoice/Financing Request Instructions and Contract Financial Reporting
for NIH Cost-Reimbursement
Type Contracts NIH(RC)-4 (Phase II), 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
courtesy copy of the original invoice shall be submitted electronically as follows:


 


		1.	The Contractor shall scan the original payment request (invoice) in Adobe Portable Document Format (PDF) along with the necessary
supporting documentation as one single attachment.



 


		2.	Save the
single attachment (scanned invoice along with any supporting documentation) in the following format: YourVendorName_Invoice number
(e.g., if you are submitting Invoice 123456, save the single attachment as "Contractor Name_Invoice 123456") [Note: Please
do not use special characters such as (#, $, %,*, &,!) when saving your attachment. Only the underscore symbol (_) is permitted.]



 


		3.	Transmit the
saved single attachment via e-mail to the appropriate branch's Central Point of Distribution. For the purpose of this contract,
the Central Point of Distribution is NCI OA Branch B - ncibranchbinvoices@mail.nih.gov . Only one payment request shall be submitted
per e-mail and the subject line of the e-mail shall include the Contract Number_ Contract Title_ Contractor's Name_ unique Invoice
number



 


(e.g,
HHSN261201400013C_Clinical Development of IPdR for Radiosensitizafion_Shuttle Pharmaceuticals, LLS_Invoice 12345) [Note:
The original payment request must still be submitted in hard copy and mailed to the designated billing office listed in subparagraph
a, above, to meet the requirements of a "proper invoice." Also, The Contractor must certify on the payment request that
the electronic courtesy copy is a duplicate of the original invoice mailed to NIH's Office of Financial Management.]


 




    	 	- 19 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


		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 Cancer Institute.



 


		b.	Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's
name on the face page of the contract. [Note:
A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.]
If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.



 


		c.	DUNS or DUNS+4 Number. The DUNS number must identify the
Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the
payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note:
A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.]
If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.



 


		d.	Invoice Matching Option. This contract requires a two-way match.



 


		e.	Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time
regardless of the number of contracts or orders held by an organization.



 


		f.	The contract period of performance is: 9/19/2014 - 6/18/2015



 


		g.	The Contract Title is:



 


Clinical
Development of IPdR for Radiosensitization


 


		h.	Contract Line Items as follows:



 


	Line
    Item #	 	Line
    Item Description
	1	 	Clinical Development of IPdR for Radiosensitization


 


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



 




    	 	- 20 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


		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, FAR 52.232-40 (December 2013)


 


		a.	Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated
payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment
is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation
from the small business subcontractor.



 


		b.	The acceleration of payments under this clause does not provide any new rights under the prompt
Payment Act.



 


		c.	Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including
subcontracts with small business concerns for the acquisition of commercial items.



(End
of Clause)


 


ARTICLE
G.5. GOVERNMENT PROPERTY


 


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



http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix
Q _HHS Contracting Guide.pdf.


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


 


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


 


Division
of Logistics Services, NIH


Property
Management Branch


6011
Building, Suite 639


6011
EXECUTIVE BLVD MSC 7670


BETHESDA
MD 20892-7670


nihcontractproperty@nih.gov


 


		b.	Notwithstanding the provisions outlined in the HHS Publication, "HHS Contracting Guide for Contract of Government Property,"
which is incorporated in this contract in paragraph a. above, the Contractor shall use the form entitled, "Report of Government
Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by the Contracting
Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.



 


		c.	Contractor-Acquired Government Property - Schedule l-B



 


Pursuant
to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the Contractor will be authorized to acquire the property listed
in the attached Schedule l-B for use in direct performance of the contract, following receipt of the Contracting Officer’s
written approval, based on contractor-furnished prices and evidence of competition. Schedule l-B is included as an attachment in
SECTION J of this contract.


 




    	 	- 21 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


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 evaluations
will be prepared Annually as determined by the Contracting Officer.


 


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



 


SECTION H - SPECIAL CONTRACT REQUIREMENTS


 


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


 


		a.	The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected
in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research
Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually
that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45
CFR Part 46 and the Assurance of Compliance.



 


		b.	The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects
under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto
agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor
shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor,
or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The
Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work
pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability
on the part of the Government for the acts of the Contractor or its employees.



 


		c.	If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that
the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting
Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects
the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing.
If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written
notice of
suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's
name may be removed from the list of those contractors with approved Human Subject Assurances.



 


(End
of clause)


 




    	 	- 22 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


ARTICLE
H.2. HUMAN SUBJECTS


 


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


 


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


 


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


 


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


 


(End
of clause)


 


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


 


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


 


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


 


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


 


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


 


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


 


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


 




    	 	- 23 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


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


 


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


 


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


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


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


 


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


 


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


 


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


 


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


 


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


 


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



 


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



 


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


 


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


 


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


 


ARTICLE H.7. 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.


 




    	 	- 24 -	 



     


    

 


Contract
Number : HHSN261201400013C


 


ARTICLE
H.8. 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.9. 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.10. RESTRICTION ON ABORTIONS


 


The
Contractor shall not use contract funds for any abortion.


 


ARTICLE H.11. 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.12. DISSEMINATION OF FALSE OR DELIBERATELY
MISLEADING INFORMATION


 


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


 


ARTICLE
H.13. PRIVACY ACT, HHSAR 352.224-70 (January 2006)


 


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


 


(End
of clause)


 


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


 




    	 	- 25 -	 



     


    

 


Contract Number : HHSN261201400013C


 





The Privacy Act System of Records applicable to this project
is Number 09-25-0200. This document is incorporated into this contract as an Attachment in SECTION J of this contract. This document
is also available at: http:// oma.od.nih.gov/public/MS/privacy/PAfiles/read02svstems.htm.


 


ARTICLE H. 14. OMB CLEARANCE


 


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


 


ARTICLE H. 15. RESTRICTION ON PORNOGRAPHY ON
COMPUTER NETWORKS


 


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


 


ARTICLE H. 16. GUN CONTROL


 


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


 


ARTICLE H. 17. CERTIFICATION OF FILING AND PAYMENT
OF TAXES


 


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


 


ARTICLE H. 18. OPTION PROVISION


 


Unless the Government exercises its
option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement
of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-9, Option to Extend the Term of the Contract
set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform
additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises
this option, notice must be given at least 30 calendar 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 OPTION FOR PHASE II Article in SECTION B of this contract.


 


ARTICLE H. 19. LIMITATIONS ON SUBCONTRACTING -
SBIR


 


Phase I - The Contractor shall perform
a minimum of two-thirds of the research and/or analytical effort (total contract price less profit/fee) conducted under this contract.
Any deviation from this requirement must be approved in writing by the Contracting Officer.


 


Phase II - The Contractor shall perform a minimum of one-half of
the research and/or analytical effort (total contract price less profit/fee) conducted under this contract. Any deviation from
this requirement must be approved in writing by the Contracting Officer.


 




    	 	- 26 -	 



     


    

 


Contract Number : HHSN261201400013C


 


ARTICLE H.20. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY,
HHSAR 352.239-73(b) (January 2010)


 


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



 


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



 


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



 


[(End of HHSAR 352.239-73(b)]


 


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



 


Schedule for Contractor Submission of Section 508 Annual
Report: Annually

[End of HHSAR 352.239-73(c)]


 


ARTICLE H.21. 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.



 






    	 	- 27 -	 



     


    






 


Contract Number : HHSN261201400013C


 


		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:


 


All data on participants in the clinical trial(s) performed
under this contract.


 


ARTICLE H.22. INSTITUTIONAL RESPONSIBILITY REGARDING
INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST - PHASE II


 


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


 


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



 


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



 


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



 


		3.	Intellectual property rights and interests, upon receipt
of income related to such rights and interest.



 




    	 	- 28 -	 



     


    

 


Contract Number : HHSN261201400013C


 


Significant financial interests do not include the following:


 


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



 


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



 


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



 


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



 


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



 


		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.



 






    	 	- 29 -	 



     


    

 


Contract Number : HHSN261201400013C


 


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



 


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


 


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


 


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


 


ARTICLE H.23. 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 Cancer Institute, National Institutes of Health, Department of Health and Human Services,
under Contract No. HHSN261201400013C"


 


ARTICLE H.24. REPORTING MATTERS
INVOLVING FRAUD, WASTE AND ABUSE


 


Anyone who becomes aware of the existence or apparent existence
of fraud, waste and abuse in NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office in
writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls
will be handled confidentially. The website to file a complaint on-line is: http://oig.hhs.gov/fraud/hotline/ and the mailing
address is:


 


US Department of Health and Human Services


Office of Inspector General


ATTN: OIG HOTLINE OPERATIONS


P.O. Box 23489


Washington, D.C. 20026


 




    	 	- 30 -	 



     


    

 


Contract Number : HHSN261201400013C


 


ARTICLE H.25. 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.26. USE OF FUNDS FOR PROMOTIONAL
ITEMS


 


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


 




    	 	- 31 -	 



     


    

 


Contract Number : HHSN261201400013C


 


PART II - CONTRACT CLAUSES


 


SECTION I - CONTRACT CLAUSES


 


ARTICLE I.1. GENERAL CLAUSES FOR A FIXED-PRICE RESEARCH
AND DEVELOPMENT SBIR PHASE I CONTRACT


 


This contract incorporates the following clauses by
reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make
their full text available. Also, the full text of a clause may be accessed electronically as follows: FAR Clauses at: http://www.
acquisition, gov/far/. HHSAR Clauses at: http:// www.hhs.gov/policies/hhsar/subpart352.html.


 


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


 


	FAR	 	 	 	 
	CLAUSE
    NO.	 	DATE	 	TITLE
	 	 	 	 	 
	52.202-1	 	Nov 2013	 	Definitions (Over the Simplified Acquisition
    Threshold)
	 	 	 	 	 
	52.203-12	 	Oct 2010	 	Limitation on Payments to Influence Certain
    Federal Transactions (Over $150,000)
	 	 	 	 	 
	52.203-17	 	Apr 2014	 	Contractor Employee Whistleblower Rights
    and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.204-10	 	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)
	 	 	 	 	 
	52.215-8	 	Oct 1997	 	Order of Precedence - Uniform Contract Format
	 	 	 	 	 
	52.219-6	 	Jul 1996	 	Notice of Total Small Business Set-Aside
	 	 	 	 	 
	52.222-3	 	Jun 2003	 	Convict Labor
	 	 	 	 	 
	52.222-21	 	Feb 1999	 	Prohibition of Segregated Facilities
	 	 	 	 	 
	52.222-26	 	Mar 2007	 	Equal Opportunity
	 	 	 	 	 
	52.222-35	 	Jul 2014	 	Equal Opportunity for Veterans ($100,000
    or more)
	 	 	 	 	 
	52.222-36	 	Jul 2014	 	Equal Opportunity for Workers with Disabilities
	 	 	 	 	 
	52.222-37	 	Jul 2014	 	Employment Reports on Veterans ($100,000
    or more)
	 	 	 	 	 
	52.222-50	 	Feb 2009	 	Combating Trafficking in Persons
	 	 	 	 	 
	52.222-54	 	Aug 2013	 	Employment Eligibility Verification (Over
    the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.223-6	 	May 2001	 	Drug-Free Workplace
	 	 	 	 	 
	52.223-18	 	Aug 2011	 	Encouraging Contractor Policies to Ban Text
    Messaging While Driving
	 	 	 	 	 
	52.225-1	 	May 2014	 	Buy American - Supplies
	 	 	 	 	 
	52.225-13	 	Jun 2008	 	Restrictions on Certain Foreign Purchases
	 	 	 	 	 
	52.227-1	 	Dec 2007	 	Authorization and Consent, Alternate I (Apr
    1984)
	 	 	 	 	 
	52.227-2	 	Dec 2007	 	Notice and Assistance Regarding Patent and
    Copyright Infringement
	 	 	 	 	 
	52.227-11	 	May 2014	 	Patent Rights - Ownership by the Contractor
    (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i)
    through (iv). The frequency of reporting in (i) is annual.


 




    	 	- 32 -	 



     


    

 


Contract Number : HHSN261201400013C


 


	FAR

        CLAUSE NO.
	 	DATE	 	TITLE
	 	 	 	 	 
	52.227-20	 	May 2014	 	Rights in Data
    - SBIR Program
	 	 	 	 	 
	52.232-9	 	Apr 1984	 	Limitation on
    Withholding of Payments
	 	 	 	 	 
	52.232-23	 	May 2014	 	Assignment of
    Claims
	 	 	 	 	 
	52.232-25	 	Jul 2013	 	Prompt Payment
	 	 	 	 	 
	52.232-33	 	Jul 2013	 	Payment by Electronic
    Funds Transfer-System for Award Management
	 	 	 	 	 
	52.232-39	 	Jun 2013	 	Unenforceability
    of Unauthorized Obligations
	 	 	 	 	 
	52.233-1	 	May 2014	 	Disputes
	 	 	 	 	 
	52.233-3	 	Aug 1996	 	Protest After
    Award
	 	 	 	 	 
	52.233-4	 	Oct 2004	 	Applicable Law
    for Breach of Contract Claim
	 	 	 	 	 
	52.243-1	 	Aug 1987	 	Changes - Fixed
    Price, Alternate V (Apr 1984)
	 	 	 	 	 
	52.244-6	 	Jul 2014	 	Subcontracts
    for Commercial Items
	 	 	 	 	 
	52.249-1	 	Apr 1984	 	Termination for
    the Convenience of the Government (Fixed-Price) (Short Form)
	 	 	 	 	 
	52.249-9	 	Apr 1984	 	Default (Fixed-Price
    Research and Development) (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	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
	 	 	 	 	 
	352.203-70	 	Mar 2012	 	Anti-Lobbying
	 	 	 	 	 
	352.222-70	 	Jan 2010	 	Contractor Cooperation in Equal Employment
    Opportunity Investigations
	 	 	 	 	 
	352.227-70	 	Jan 2006	 	Publications and Publicity
	 	 	 	 	 
	352.231-71	 	Jan 2001	 	Pricing of Adjustments
	 	 	 	 	 
	352.242-70	 	Jan 2006	 	Key Personnel
	 	 	 	 	 
	352.242-73	 	Jan 2006	 	Withholding of Contract Payments


 


[End of GENERAL CLAUSES FOR A FIXED-PRICE
RESEARCH AND DEVELOPMENT SBIR PHASE I CONTRACT- Rev. 08/2014].


 




    	 	- 33 -	 



     


    

 


Contract Number : HHSN261201400013C


 


ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT
SBIR PHASE II CONTRACT


 


This contract incorporates the
following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting
Officer will make their full text available. Also, the full text of a clause may be accessed electronically as follows: FAR Clauses
at: http://www.acquisition.gov/far/. HHSAR Clauses at: http://www.hhs. gov/policies/hhsar/subpart352.html.


 


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



 


	FAR

        CLAUSE NO.
	 	DATE	 	TITLE
	52.202-1	 	Nov 2013	 	Definitions (Over the Simplified Acquisition
    Threshold)
	 	 	 	 	 
	52.203-3	 	Apr 1984	 	Gratuities (Over the Simplified Acquisition
    Threshold)
	 	 	 	 	 
	52.203-5	 	May 2014	 	Covenant Against Contingent Fees (Over the
    Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-6	 	Sep 2006	 	Restrictions on Subcontractor Sales to the
    Government (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-7	 	May 2014	 	Anti-Kickback Procedures (Over the Simplified
    Acquisition Threshold)
	 	 	 	 	 
	52.203-8	 	May 2014	 	Cancellation, Rescission, and Recovery of
    Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-10	 	May 2014	 	Price or Fee Adjustment for Illegal or Improper
    Activity (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.203-12	 	Oct 2010	 	Limitation on Payments to Influence Certain
    Federal Transactions (Over $150,000)
	 	 	 	 	 
	52.203-17	 	Apr 2014	 	Contractor Employee Whistleblower Rights
    and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.204-4	 	May 2011	 	Printed or Copied Double-Sided on Postconsumer
    Fiber Content Paper (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.204-10	 	Jul 2013	 	Reporting Executive Compensation and First-Tier
    Subcontract Awards ($25,000 or more)
	 	 	 	 	 
	52.204-13	 	Jul 2013	 	System for Award Management Maintenance
	 	 	 	 	 
	52.209-6	 	Aug 2013	 	Protecting the Government's Interest When
    Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)
	 	 	 	 	 
	52.215-2	 	Oct 2010	 	Audit and Records
    - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value,
    AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]
	 	 	 	 	 
	52.215-8	 	Oct 1997	 	Order of Precedence - Uniform Contract Format
	 	 	 	 	 
	52.215-10	 	Aug 2011	 	Price Reduction for Defective Certified Cost
    or Pricing Data (Over $700,000)
	 	 	 	 	 
	52.215-12	 	Oct 2010	 	Subcontractor Cost or Pricing Data (Over
    $700,000)
	 	 	 	 	 
	52.215-14	 	Oct 2010	 	Integrity of Unit Prices (Over the Simplified
    Acquisition Threshold)
	 	 	 	 	 
	52.215-15	 	Oct 2010	 	Pension Adjustments and Asset Reversions
    (Over $700,000)
	 	 	 	 	 
	52.215-18	 	Jul 2005	 	Reversion or Adjustment of Plans for Post-Retirement
    Benefits (PRB) other than Pensions
	 	 	 	 	 
	52.215-19	 	Oct 1997	 	Notification of Ownership Changes


 




    	 	- 34 -	 



     


    

 


Contract Number : HHSN261201400013C


 


	FAR

        CLAUSE NO.
	 	DATE	 	TITLE
	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
	 	 	 	 	 
	52.219-6	 	Jul 1996	 	Notice of Total Small Business Set-Aside
	 	 	 	 	 
	52.219-8	 	May 2014	 	Utilization of Small Business Concerns (Over
    the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.219-14	 	Dec 1996	 	Limitations on Subcontracting
	 	 	 	 	 
	52.222-2	 	Jul 1990	 	Payment for Overtime Premium (Over the Simplified
    Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)
	 	 	 	 	 
	52.222-3	 	Jun 2003	 	Convict Labor
	 	 	 	 	 
	52.222-21	 	Feb 1999	 	Prohibition of Segregated Facilities
	 	 	 	 	 
	52.222-26	 	Mar 2007	 	Equal Opportunity
	 	 	 	 	 
	52.222-35	 	Jul 2014	 	Equal Opportunity for Veterans ($100,000
    or more)
	 	 	 	 	 
	52.222-36	 	Jul 2014	 	Equal Opportunity for Workers with Disabilities
	 	 	 	 	 
	52.222-37	 	Jul 2014	 	Employment Reports on Veterans ($100,000
    or more)
	 	 	 	 	 
	52.222-40	 	Dec 2010	 	Notification of Employee Rights Under the
    National Labor Relations Act (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.222-50	 	Feb 2009	 	Combating Trafficking in Persons
	 	 	 	 	 
	52.222-54	 	Aug 2013	 	Employment Eligibility Verification (Over
    the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.223-6	 	May 2001	 	Drug-Free Workplace
	 	 	 	 	 
	52.223-18	 	Aug 2011	 	Encouraging Contractor Policies to Ban Text
    Messaging While Driving
	 	 	 	 	 
	52.225-1	 	May 2014	 	Buy American - Supplies
	 	 	 	 	 
	52.225-13	 	Jun 2008	 	Restrictions on Certain Foreign Purchases
	 	 	 	 	 
	52.227-1	 	Dec 2007	 	Authorization and Consent, Alternate I (Apr
    1984)
	 	 	 	 	 
	52.227-2	 	Dec 2007	 	Notice and Assistance Regarding Patent and
    Copyright Infringement
	 	 	 	 	 
	52.227-11	 	May 2014	 	Patent Rights
    - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements
    in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
	 	 	 	 	 
	52.227-20	 	May 2014	 	Rights in Data - SBIR Program
	 	 	 	 	 
	52.232-9	 	Apr 1984	 	Limitation on Withholding of Payments
	 	 	 	 	 
	52.232-17	 	May 2014	 	Interest (Over the Simplified Acquisition
    Threshold)
	 	 	 	 	 
	52.232-20	 	Apr 1984	 	Limitation of Cost
	 	 	 	 	 
	52.232-23	 	May 2014	 	Assignment of Claims
	 	 	 	 	 
	52.232-25	 	Jul 2013	 	Prompt Payment, Alternate I (Feb 2002)
	 	 	 	 	 
	52.232-33	 	Jul 2013	 	Payment by Electronic Funds Transfer–System
    for Award Management
	 	 	 	 	 
	52.232-39	 	Jun 2013	 	Unenforceability of Unauthorized Obligations
	 	 	 	 	 
	52.233-1	 	May 2014	 	Disputes


 




    	 	- 35 -	 



     


    

 


Contract Number : HHSN261201400013C


 


	FAR	 	 	 	 
	CLAUSE
    NO.	 	DATE	 	TITLE
	 	 	 	 	 
	52.233-3	 	Aug 1996	 	Protest
    After Award, Alternate I (Jun 1985)
	 	 	 	 	 
	52.233-4	 	Oct 2004	 	Applicable
    Law for Breach of Contract Claim
	 	 	 	 	 
	52.242-1	 	Apr 1984	 	Notice
    of Intent to Disallow Costs
	 	 	 	 	 
	52.242-3	 	May 2014	 	Penalties
    for Unallowable Costs (Over $700,000)
	 	 	 	 	 
	52.242-4	 	Jan 1997	 	Certification
    of Final Indirect Costs
	 	 	 	 	 
	52.242-13	 	Jul
    1995	 	Bankruptcy
    (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.243-2	 	Aug 1987	 	Changes
    - Cost Reimbursement, Alternate V (Apr 1984)
	 	 	 	 	 
	52.244-2	 	Oct 2010	 	Subcontracts
    (Over the Simplified Acquisition Threshold), Alternate 1 (June 2007)
	 	 	 	 	 
	52.244-5	 	Dec 1996	 	Competition
    in Subcontracting (Over the Simplified Acquisition Threshold)
	 	 	 	 	 
	52.244-6	 	Jul 2014	 	Subcontracts
    for Commercial Items
	 	 	 	 	 
	52.245-1	 	Apr 2012	 	Government
    Property
	 	 	 	 	 
	52.245-9	 	Apr 2012	 	Use
    and Charges
	 	 	 	 	 
	52.249-6	 	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 COST-REIMBURSEMENT SBIR PHASE II CONTRACT- Rev. 08/2014].


 




    	 	- 36 -	 



     


    

 


Contract Number : HHSN261201400013C


 


ARTICLE I.2. AUTHORIZED SUBSTITUTION OF
CLAUSES


 


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


 


		a.	Alternate I (October 1997) of FAR Clause 52.215-14,
Integrity of Unit Prices (October 2010) is added.



 


		b.	The following clauses are added to this contract (Phase
I only):



 


		•	FAR Clause 52.203-3, Gratuities (April 1984)



 


		•	FAR Clause
                                         52.203-5, Covenant Against Contingent Fees (May 2014)



 


		•	FAR Clause
                                         52.203-6, Restrictions on Subcontractor Sales to the Government (September 2006)



 


		•	FAR Clause
                                         52.203-7, Anti-Kickback Procedures (May 2014)



 


		•	FAR Clause
                                         52.203-8, Cancellation, Recission, and Recovery of Funds for Illegal or Improper Activity
                                         (May 2014)



 


		•	FAR Clause
                                         52.203-10, Price or Fee Adjustment for Illegal or Improper Activity (May 2014)



 


		•	FAR Clause
                                         52.204-4, Printed or copied Double-Sided on Postconsumer Fiber Content Paper (May
                                         2011)



 


		•	FAR Clause
                                         52.215-2, Audit and Records Negotiation (October 2010)



 


		•	FAR Clause
                                         52.215-14, Integrity of Unit Prices (October 2010)



 


		•	FAR Clause
                                         52.219-8, Utilization of Small Business Concerns (May 2014)



 


		•	FAR Clause
                                         52.219-14, Limitations on Subcontracting (December 1996)



 


		•	FAR Clause
                                         52.222-40, Notification of Employee Rights Under the National Labor Relations Act
                                         (December 2010)



 


		•	FAR Clause
                                         52.229-3, Federal, State and Local Taxes (February 2013)



 


		•	FAR Clause
                                         52.232-2, Payments under Fixed-Price Research and Development Contracts (April
                                         1984)



 


		•	FAR Clause
                                         52.232-17, Interest (May 2014)



 


		•	FAR
                                         Clause 52.242-13, Bankruptcy (July 1995)



 


		•	FAR Clause
                                         52.244-5, Competition in Subcontracting (December 2010)



 


The following clause(s) is substituted as follows:


 


		•	FAR Clause
                                         52.249-1, Termination for the Convenience of the Government (Fixed-Price)(Short Form)
                                         (April 1984) is deleted in its entirety and FAR Clause 52.249-2, Termination for
                                         the Convenience of the Government (Fixed Price) (April 2012) is substituted therefor.



 


		c.	Alternate I (February 2002), of FAR Clause 52.232-25,
Prompt Payment (July 2013) is deleted.



 




    	 	- 37 -	 



     


    

 


Contract Number : HHSN261201400013C


 


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



 


		2.	FAR Clause 52.219-28,
                                         Post-Award Small Business Program Rerepresentation (July 2013).



 


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



 


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



 


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



 


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



 


		7.	FAR Clause 52.244-5,
                                         Competition in Subcontracting (December 1996).



 


		8.	Alternate
                                         I (April 2012), FAR Clause 52.245-1, Government Property (April 2012).



 


		9.	FAR Clause 52.246-23,
                                         Limitation of Liability (February 1997).



 


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



 


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



 


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



 


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


 


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


 


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


 


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



 


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


 


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



 



    	 	- 38 -	 



     


    

 


Contract Number : HHSN261201400013C


 


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 52.217-9, 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 15 calendar days before the
contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least
30 calendar 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 five (5) years.



 


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



 


THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.


 




    	 	- 39 -	 



     


    

 


Contract Number : HHSN261201400013C


 


PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS


 


SECTION J - LIST OF ATTACHMENTS


 


The following documents are attached
and incorporated in this contract:


 


1.Statement of Work


 


Statement of Work - Phase I, dated
08/25/2014, 2 pages.


 


Statement of Work - Phase II, dated
08/25/2014, 3 pages.


 


2.Invoice Instructions for NIH
Fixed-Price Contracts, NIH(RC)-2


 


Invoice Instructions for NIH Fixed-Price
Contracts, NIH(RC)-2, (8/12), 3 pages.


 


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


 


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


 


4.Cumulative Inclusion Enrollment
Report


 


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


 


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


 


5.Privacy Act System of Records,
Number


 


Privacy Act System of Records, Number
09-25-0200,10 pages.


 


6.Research Patient Care Costs


 


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


 


7.Disclosure of Lobbying Activities,
SF-LLL


 


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


 


8.Government Property - Schedule
IB


 


Government Property - Schedule IB,
dated September 19, 2014, 1 page.


 


9.Report of Government Owned,
Contractor Held Property


 


Report of Government Owned, Contractor
Held Property, dated 3/2008,1 page. Located at: http://oamp.od.nih.gov/ sites/default/files/DGS/contracting-forms/Govt-Owned-Prop.pdf


 


10.NIH Small Business Innovation Research (SBIR)
Program Funding Agreement Certification


 


NIH Small Business Innovative Research (SBIR) Program Funding Agreement
Certification, 3 Pages.


 




    	 	- 40 -	 



     


    

 


Contract Number : HHSN261201400013C


 


11.NIH Small Business Innovation Research (SBIR) Program
Life Cycle Certification


 


NIH Small Business Innovative Research (SBIR) Program Life
Cycle Certification, 3 pages.


 




    	 	- 41 -	 



     


    

 


Contract Number : HHSN261201400013C


 


PART IV - REPRESENTATIONS AND INSTRUCTIONS 


 


SECTION K - REPRESENTATIONS AND CERTIFICATIONS


 


The following documents are incorporated
by reference in this contract:


 


		1.	Annual Representations and Certifications are completed and located in The System for Award Management (SAM) website ( http://www.sam.gov).
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 February
2013



 


		4.	Human Subjects Assurance Identification Number FWA00022203.



 


END of the SCHEDULE


 


(CONTRACT)


 




    	 	- 42 -	 



     


    

 


Shuttle Pharmaceuticals, LLC


HHSN261201400013C


August 25, 2014


 


STATEMENT OF WORK - PHASE I SBIR


 


		I.	Background Information and Objectives



 


		A.	Background information



The objective of this project is to
advance commercialization efforts for IPdR (5 -iodo- 2pyrimidinone-2'-deoxyribose), a prod rug of the radiosensitizer lUdR (5-iodo-2'-
deoxyuridine). In Phase I, the Contractor shall determine the scientific merit, feasibility and potential for commercialization
of oral IPdR as a radiation sensitizer for use in cancer treatment. Administrative tasks shall be completed to enable an IND for
the Contractor; formulation of GMP manufactured IPdR into 300 mg capsules; submission of a letter of intent (LOI) to CTEP; protocol
preparation and IRB approval for the proposed Phase I clinical trial and establishment of companion diagnostics for analyzing clinical
specimens from Phase I patients. The tasks detailed for the Phase I effort are intended to facilitate an IND for IPdR for the Contractor.


 


		B.	Technical Objectives



 


Objective 1. Activate the IPdR
IND to enable the Contractor to provide GMP IPdR to the sub-contractor (BrUOG/RIH) for the Phase I and PK clinical trial.


 


Task 1.1. The Contractor shall
file administrative documents to initially cross-file (IND 70,333) and obtain an IND for IPdR to enable performance of the Phase
I and PK study at Brown University (Lifespan/RIH).





Milestone 1.1. The Contractor
shall cross-file on the IPdR IND currently held by CTEP to permit performance of the Phase I clinical trial in Phase II of this
contract.





Task 1.2. The Contractor shall
negotiate an agreement with CTEP to transfer sufficient cGMP clinical product IPdR from the NCI DTP to the Contractor for performance
of the clinical trial.





Milestone 1.2. Bulk cGMP drug
shall be formulated into clinical product (encapsulated) IPdR, 250 mg capsules, for use in the proposed Phase I and PK clinical
trial.





Task 1.3. The Contractor
shall formulate and encapsulate cGMP IPdR into capsules (250 and 500 mg).





Milestone 1.3. IPdR in capsules
of 300 mg shall be available for the Phase I and PK clinical trial.


 


Objective 2. Obtain approvals
for the Phase I and PK clinical protocol from Brown University (Lifespan/Rhode Island Hospital) and CTEP. Develop efficacy protocols
satisfying FDA “Orphan Drug” status.


 


Task 2.1. The Contractor shall
submit a Letter of Intent (LOI) to NCI CTEP for approval of the Phase I and PK clinical studies of IPdR.





Milestone 2.1. The Contractor
shall obtain a favorable response to an LOI to NCI CTEP for Phase I and PK studies.





Task 2.2. The Contractor shall obtain IRB approval
of the complete Phase I and PK study





Milestone 2.2. IRB approved Phase I for safety and feasibility of IPdR + RT.





Task 2.3. The Contractor shall
consult with the FDA regarding “Orphan Drug” status for IPdR as a radiosensitizing drug for use in rectal cancer treatment


 




    	Attachment 1 – Phase I	Page 1



     


    

 


Milestone 2.3. The Contractor
shall obtain FDA guidance on requirements for IPdR approval as an “Orphan Drug” leading to a strategy to accomplish
this task.


 


Objective 3. Establish the in-house
(Shuttle Pharmaceuticals, LLC Laboratories) biomarker assays for evaluating clinical specimens to be obtained from patients entering
IPdR clinical trials.


 


Task 3.1. The Contractor shall
establish plasma IPdR—>IUdR—>IU PK and %IUdR-DNA cellular incorporation assays in the Contractor’s laboratories
for use in patient plasma and tissue samples during the IPdR Phase I and PK dose escalation.





Milestone 3.1. The Contractor shall optimize LC/MS/MS
PK, HPLC and flow cytometry assays for %IUdR-DNA incorporation in cells.





Task 3.1. The Contractor shall complete the Phase
I work plan and report progress and achieved milestones to NIH to allow the project to progress to the Phase II work plan. 





Milestone
3.2. The Contractor shall prepare a written report of Phase I progress and achieved milestones submitted and accepted by NIH.


 


		II.	Services to be performed



 


		A.	General Requirements



 


1.The Contractor shall independently perform
all work and furnish all labor, materials, supplies, equipment and services (except as otherwise specified in the contract)


 


2.All work shall be monitored
by the Government Contracting Officer’s Representative.


 


B.Specific Requirements are
summarized in Gantt Chart 1:


 


Chart 1. Phase I. Milestones, Deliverables, Timeline and
Work Distribution between the Contractor and Lifespan/Rhode Island Hospital (L/RIH).


 





	Site	 	Milestones
    and Deliverables	 	Months
	 	 	 	 	1	 	2	 	3	 	4	 	5	 	6	 	7	 	8	 	9
	
        SP,

        L/RIH
	 	
        Objective 1. Task 1.1.

        Milestone 1.1. Activation of
        the IPdR IND
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	
        Objective 1. Task 1.2.

        Milestone 1.2. IPdR clinical product is obtained from
        CTEP suitable for use in the Phase I clinical trial
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	
        Objective 1. Task 1.3.

        Milestone 1.3. Sufficient quantity of 300 mg capsules
        of IPdR are provided to complete the Phase I clinical trial.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
        SP,

        L/RIH
	 	
        Objective 2. Task 2.1.

        Milestone 2.1. NCI CTEP approval
        of the Phase I and PK LOI.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
        SP,

        L/RIH
	 	
        Objective 2. Task 2.2.

        Milestone 5. The Phase I clinical
        trial receives IRB approval.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	
        Objective 2. Task 2.3.

        Milestone 6. FDA provided advice for “Orphan
        Drug” status for IPdR in rectal cancer treatment.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	
        Objective 3. Task 3.1.

        Milestone 3.1. The %IUdR-DNA cellular incorporation
        assays for Phase II is established in Shuttle Pharmaceuticals laboratories.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	SP	 	
        Objective 3. Task 3.2.

        Milestone 3.2. Written final report of achieved Phase
        I SBIR milestones to advance to the Phase II SBIR.work plan.
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 







 




    	Attachment 1 – Phase I	Page 2



     


    

 


Shuttle Pharmaceuticals, LLC


HHSN261201400013C


August 25, 2014


 


STATEMENT OF WORK - PHASE II SBIR


 


		I.	Background Information and Objectives



 


		A.	Background information



Although radiosensitization is integral
to the treatment of many types of human cancers, the drugs currently available are also cytotoxic, and there is no drug with FDA
approval for the indication of radiosensitization. IPdR represents a potential first-in-class non-cytotoxic radiation sensitizer
to biologically enhance radiation therapy effects on cancers. In Phase II, the Phase I clinical trial will be performed to determine
safety and feasibility. This shall allow the Contractor to advance its proposed commercialization plan and to raise capital for
efficacy clinical trials leading to FDA approval.


 


		B.	Technical Objectives



 


Objective 1: Perform the Phase I and PK clinical
trial of IPdR-mediated radiosensitization in patients with locally advanced gastrointestinal cancers, presenting for palliative
radiation therapy to the abdominal and/or pelvic regions.


 


The Contractor shall:


 


Task 1.1. Perform the Phase
I clinical trial.





Milestone 1.1. Initiation and performance of the
Phase I and PK clinical trial of lUdR with RT.





Milestone 1.3. Collect and transfer clinical samples
to the Contractor’s laboratories for analysis.


 


Objective 2: Perform PK analyses
to determine optimal dosing schedule of IPdR and perform biomarker assays of %IUdR-DNA cellular incorporation in clinical specimens.


 


The Contractor shall:


 


Task 2.1. Determine pharmacokinetics (PK) and
%IUdR-DNA for biomarker analysis.





Milestone 2.1. Obtain and analyze clinical specimens
for PK & %IUdR-DNA determinations.





Milestone 2.2. Perform PK analyses.





Milestone 2.3. Determine and correlate %IUdR-DNA
incorporation with clinical observations.


 






    	Attachment 1 – Phase II	Page 1



     


    

 


Objective 3: Use results of the Phase I
and PK clinical trial to design the Phase IB/ll clinical trials in patients with rectal cancers.


 


The Contractor shall:


 


Task 3.1. Analyze
the PK data to determine optimal IPdR dosing.


Milestone 3.1. Establish
optimum dosing schedule of IPdR, based on PK data.


Task 3.2. Design and
write the Phase IB/ll protocol for efficacy determination.


Milestone 3.2. Write
Phase IB/ll clinical protocol for IPdR and RT in rectal cancer.


 


Objective 4: Advance the business development
and commercialization plan for company sustainability


 


The Contractor shall:


 


Task 4.1. Advance results of the Phase
I clinical trial to raise capital for efficacy clinical trials of IPdR and RT.


Milestone 4.1. Ensure that the written
business development and commercialization plan is available for entering capital markets to commercialize IPdR.


Task 4.2. Prepare and submit a final written
report to the Government at the conclusion of the Phase II contract.


Milestone 4.1. Submit
written final progress report.


 


		II.	Services to be performed



 


A.
General Requirements


 


1. The Contractor shall
independently perform all work and furnish all labor, materials, supplies, equipment and services (except as otherwise
specified in the contract)


 


2. All work shall be monitored by
the Contracting Officer’s Representative.


 




    	Attachment 1 - Phase II	Page 2



     


    

 


B. Specific
Requirements


 


The tasks are detailed for the Phase II effort,
intended to perform the Phase I clinical trial and PK study for IPdR for Shuttle Pharmaceuticals are summarized in Gantt Chart
2:


 


Chart 2. Phase II Milestones, Deliverables and
Work Distribution between the Contractor and Lifespan/Rhode Island Hospital (L/RIH) for Clinical Development of IPdR as a Radiosensitizer.


 


	 	 	Delivery
    Schedule (months)
	Site	Milestones
    and Deliverables	2	4	6	8	10	12	14	16	18	20	22	24
	L/RIH	Obiective 1. Task
        1.1

        Milestone 1.1.
        Initiation and performance of the Phase I and PK clinical trial of lUdR with RT.

        Milestone 1.2.
        Safety and MTD parameters for IPdR with RT.

        Milestone 1.3.
        Collect and transfer clinical samples to SP Labs.
	 	 	 	 	 	 	 	 	 	 	 	 
	L/RIH

        SP
	Obiective 2. Task
        2.1.

        Milestone 2.1.
        Obtain clinical specimens for PK & %IUdR-DNA

        Milestone 2.2.
        PK analyses

        Milestone 2.3.
        %IUdR-DNA incorporation is determined and correlated with clinical observations.
	 	 	 	 	 	 	 	 	 	 	 	 
	SP	Obiective 3: Task
        3.1.

        Milestone 3.1.
        Dosing schedule of IPdR is established, based on PK
	 	 	 	 	 	 	 	 	 	 	 	 
	SP	Obiective 3: Task
        3.2.

        Milestone 3.2.
        Written Phase IB/ll clinical protocol
	 	 	 	 	 	 	 	 	 	 	 	 
	SP	Obiective 4: Task
        4.1.

        Milestone 4.1
        Written business and commercialization plan.
	 	 	 	 	 	 	 	 	 	 	 	 
	SP,

        L/RIH
	Obiective 4: Task
        4.2.

        Milestone 4.2.
        Final report submitted to NIH.
	 	 	 	 	 	 	 	 	 	 	 	 


 




    	Attachment 1 - Phase II	Page 3



     


    

 


INVOICE INSTRUCTIONS FOR
NIH FIXED-PRICE CONTRACTS. NIH(RC)-2


 


Format: Submit payment requests on Standard
Form 1034, Public Voucher for Purchases and Services Other Than Personal, or the Contractor’s self-generated form provided it contains
all of the information prescribed herein. DO NOT include a cover letter with the payment request.


 


Number of Copies: Submit payment requests
in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.


 


Frequency: Submit payment requests upon delivery
and acceptance of goods or services unless otherwise authorized by the Contracting Officer.


 


Currency: All NIH contracts
are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall
be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred.
Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices
paid under this contract may not exceed the United States dollars authorized.


 


Preparation and Itemization
of the Payment Request: Prepare payment requests as follows:


 


		Note:	All information must be legible or the invoice
                                         will be considered improper and returned to the Contractor.



 


		(a)	Designated Billing Office Name and Address: Enter
the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract
Schedule.



 


		(b)	Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address
exactly as they appear in the contract. Any invoice identified as improper will be sent to this address. Also include the name,
title, phone number, and e-mail address of the Point of Contact in case of questions. If the remittance name differs from the legal
business name, both names must appear on the invoice. Provide the Contractor’s Federal Taxpayer Identification Number (TIN) and
Data Universal Numbering System (DUNS) or DUNS+4 number. The DUNS number must identify the Contractor’s name and address exactly
as stated in the contract, and as registered in the System for Acquisition Management (SAM) database.



 


When an approved assignment
of claims has been executed, the Contractor shall provide the same information for the assignee as is required for the Contractor
(i.e., name, address, point of contact, TIN, and DUNS number), with the remittance information clearly identified as such.


 


		(c)	Invoice/Voucher Number: Identify each payment request by a unique invoice number, which can only be used one time regardless
of the number of contracts or orders held by an organization. For example, if a contractor has already submitted invoice number
05 on one of its contracts or orders, it cannot use that same invoice number on any other contract or order. Payment requests with
duplicate invoice numbers will be considered improper and returned to the contractor.



 




    	 	1	Attachment 2 



     


    

 


The NIH does not prescribe
a particular numbering format but suggests using a job or account number for each contract and order followed by a sequential invoice
number (example: 8675309-05). Invoice numbers are limited to 30 characters. There are no restrictions on the use of special characters,
such as colons, dashes, forward slashes, or parentheses.


 


If all or part of an invoice
is suspended and the contractor chooses to reclaim those costs on a supplemental invoice, the contractor may use the same unique
invoice number followed by an alpha character, such as “R” for revised (example: 8675309-05R).


 


		(d)	Date Invoice/Voucher Prepared: Insert the date the
payment request is prepared.



 


		(e)	Contract Number and Order Number (if applicable): Insert
the contract number and order number (as applicable).



 


		(f)	Contract Title: Insert the contract title listed on the cover page of the contract and/or Section G of the Contract
Schedule.



 


		(g)	Current Contract Period of Performance: Insert the contract start date/effective date through the current completion
date of the contract.



 


		(h)	Total Fixed-Price of Contract/Order: Insert the total fixed-price of the contract/order.



 


		(i)	Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three-way match. To determine required
payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.



 


		(j)	Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions
in Section G of the Contract Schedule.



 


		(k)	Central Point of Distribution: Identify the Central Point of Distribution, as specified in the Invoice Submission Instructions
in Section G of the Contract Schedule.



 


		(I)	Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred
and for which reimbursement is claimed.



 


		(m)	Description of Supplies or Services: Provide a description of the supplies or services,
by line item (if applicable), quantity, unit price (where appropriate), and total amount. The item description, unit of measure,
and unit price must match those specified in the contract. For example, if the contract specifies 1 box of hypodermic needles
(100/box) with a unit price of $50.00, then the invoice must state 1 box, hypodermic needles (100/box), $50.00, not 100
syringes at $0.50 each. Invoices that do not match the line item pricing in the contract will be considered improper and will be
returned to the Contractor.



 


		(n)	Amount Billed - Current Period: Insert the amount
claimed for the current billing period, including any adjustments, if applicable. If the Contract Schedule contains separately
priced line items, identify the contract line item(s) on the payment request.



 


		(o)	Amount Billed - Cumulative: Insert the cumulative amounts claimed to date, including any
                                                                              adjustments as applicable. If the Contract Schedule contains separately priced line items, identify the contract line item(s)
                                                                              on the payment request.



 




    	 	2	 



     


    

 


		(p)	Freight or Delivery Charges: Identify all charges
for freight or express shipments, other than f.o.b. destination, as a separate line item on the invoice. (If shipped by freight
or express, and charges are more than $25, attach prepaid bill.)



 


		(q)	Government Property: If the contract authorizes
the purchase of any item of Government Property (e.g., equipment), the invoice must list each item for which reimbursement is
requested. Include reference to the following (as applicable):



 


		-	item number for the specific piece of equipment listed
in the Property Schedule, and



		-	Contracting Officer Authorization (COA) Number, if
the equipment is not covered by the Property Schedule.



 




    	 	3	 



     


    

 


INVOICE/FINANCING REQUEST AND CONTRACT
FINANCIAL REPORTING INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS. NIH(RC)-4


 


Format: Submit payment requests on the Contractor’s
self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard
Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated
form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with
the payment request.


 


Number of Copies: Submit payment requests
in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.


 


Frequency: Payment requests shall not be submitted
more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract.
Small business concerns may submit invoices/financing requests more frequently than every two weeks.


 


Cost Incurrence Period: Costs incurred must
be within the contract performance period or covered by precontract cost provisions.


 


Billing of Costs Incurred: : If billed costs
include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed
after the contract period has expired, the Contractor shall cite the amount(s) and month(s) in which the costs were incurred.


 


Contractor’s Fiscal Year: Prepare payment
requests in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.


 


Currency: All NIH contracts
are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall
be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred.
Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices
paid under this contract shall not exceed the United States dollars authorized.


 


Costs Requiring Advance Approval: Costs requiring
advance approval by the Contracting Officer, which are not set forth in the Contract Schedule shall be identified by the Contracting
Officer’s Authorization (COA) Number as a separate expenditure category on the payment request. In addition, the Contractor shall
show any cost limitation or ceiling set forth in the Contract Schedule, i.e. an Advance Understanding, as a separate expenditure
category on the payment request.


 


Invoice/Financing Request
Identification: Identify each payment as either:


 


		(a)	Interim Invoice/Contract Financing Request: These
are interim payment requests submitted during the contract performance period.



 


		(b)	Completion Invoice: Submit the completion invoice
promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement
of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The
Contractor shall submit the completion invoice when all costs have been assigned to the contract and all performance provisions
have been completed.



 


		(c)	Final Invoice: A final invoice may be required after
the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).



 




    	 	1	Attachment 3 



     


    

 


Preparation and Itemization
of the Invoice/Financing Request:


 


The Contractor shall furnish
the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing
Request. All information must be legible or the invoice will be considered improper and returned to the Contractor.


 


		(a)	Designated Billing Office Name and Address: Enter
the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract
Schedule.



 


		(b)	Contractor’s Name, Address, Point of Contact, TIN, and
DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract. Any invoice identified
as improper will be sent to this address. Also include the name, title, phone number, and e-mail address of the Point of Contact
in case of questions. If the remittance name differs from the legal business name, both names must appear on the invoice. Provide
the Contractor’s Federal Taxpayer Identification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4 number. The
DUNS number must identify the Contractor’s name and address exactly as stated in the contract, and as registered in the System
for Award Management (SAM) database.



 


When an approved assignment
of claims has been executed, the Contractor shall provide the same information for the assignee as is required for the Contractor
(i.e., name, address, point of contact, TIN, and DUNS number), with the remittance information clearly identified as such.


 


		(c)	Invoice/Financing Request Number: Identify each
payment request by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held
by an organization. For example, if a contractor has already submitted invoice number 05 on one of its contracts or orders, it
cannot use that same invoice number on any other contract or order. Payment requests with duplicate invoice numbers will be considered
improper and returned to the contractor.



 


The NIH does not prescribe a particular numbering
format but suggests using a job or account number for each contract and order followed by a sequential invoice number (example:
8675309-05). Invoice numbers are limited to 30 characters. There are no restrictions on the use of special characters, such as
colons, dashes, forward slashes, or parentheses.


 


If all or part of an invoice
is suspended and the contractor chooses to reclaim those costs on a supplemental invoice, the contractor may use the same unique
invoice number followed by an alpha character, such as “R” for revised (example: 8675309-05R).


 


		(d)	Date Invoice/Financing Request Prepared: Insert
the date the payment request is prepared.



 


		(e)	Contract Number and Order Number (if applicable): Insert
the contract number and order number (as applicable).



 


		(f)	Contract Title: Insert the contract title exactly
as it appears on the cover page of the contract and/or Section G of the Contract Schedule.



 


		(g)	Current Contract Period of Performance: Insert the
contract start date/effective date through the current completion date of the contract.



 




    	 	2	 



     


    

 


		(h)	Total Estimated Cost of Contract/Order: Insert the
total estimated cost of the contract, exclusive of fee. If billing under an order, insert the total estimated cost of the order,
exclusive of fee. For contracts/orders with options or incremental funding provisions, enter the amount currently obligated and
available for payment.



 


		(i)	Total Fixed-Fee:
                                         Insert the total fixed-fee (where applicable). For contracts/orders with options
                                         or incremental funding provisions, enter the amount currently obligated and available
                                         for payment (where applicable). Note: If the contract provides for another
                                         type of Fee, i.e. Award or Incentive Fee, insert the amount available to be earned as
                                         identified in the contract and indicate the type of fee to be billed on the payment request.



 


		(j)	Two-Way/Three-Way Match: Identify whether payment
is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions
in Section G of the Contract Schedule.



 


		(k)	Office of Acquisitions: Insert the name of the Office
of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.



 


		(I)	Central Point of Distribution: Insert the Central
Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.



 


		(m)	Billing Period: Insert the beginning and ending
dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.



 


		(n)	Amount Billed - Current Period: Insert the amount
claimed for the current billing period by major cost element, including any adjustments and fee. If the Contract Schedule contains
separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major
cost element) for each line item.



 


		(o)	Amount Billed - Cumulative: Insert the cumulative
amounts claimed by major cost element, including any adjustments and fee. If the Contract Schedule contains separately priced
line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element)
for each line item.



 


		(p)	Direct Costs: Insert the major cost elements. For
each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these
instructions.



 


		1)	Direct Labor: Include salaries and wages paid
(or accrued) for direct performance of the contract.



 


For Level of Effort contracts
only, the Contractor shall provide the following information on a separate sheet of paper attached to the payment request:


 


		-	hours or percentage of effort and cost by labor category
(as specified in the Level of Effort Article in Section F of the Contract Schedule) for the current billing period, and



 


		-	hours or percentage of effort and cost by labor category from contract inception through the
                                                                                current billing period. (NOTE: The Contracting Officer may require the Contractor to provide additional breakdown for direct
                                                                                labor, such as position title, employee name, and salary or hourly rate.)



 


		2)	Fringe Benefits: List any fringe benefits applicable
to direct labor and billed as a direct cost. Cite the rate(s) used to calculate fringe benefit costs, if applicable.



 




    	 	3	 



     


    

 


		3)	Accountable Personal Property: Include permanent
research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life expectancy of more
than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Contract of Government Property).
Show permanent research equipment separate from general purpose equipment.



 


On a separate sheet of paper attached to the payment
request, list each item for which reimbursement is requested. Precede the item with an asterisk (*) if the equipment is below the
$1,000 approval level. Include reference to the following (as applicable):


 


		-	item number for the specific piece of equipment listed
in the Property Schedule, and,



		-	Contracting Officer Authorization (COA) number, if
the equipment is not covered by the Property Schedule.



 


The Contracting Officer may require the Contractor
to provide further itemization of property having specific limitations set forth in the contract.


 


		4)	Materials
and Supplies: Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and
consumable material and supplies regardless of amount.



 


		5)	Premium
Pay: List remuneration in excess of the basic hourly rate.



 


		6)	Consultant
Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as
the effort (i.e., number of hours, days, etc.) and rate billed.



 


		7)	Travel:
Include domestic and foreign travel. Foreign travel is travel outside of the United States and its territories and possessions.
However, for an organization located outside the United States and its territories and possessions, foreign travel means travel
outside that country. Foreign travel must be billed separately from domestic travel.



 


		8)	Subcontract
Costs: List subcontractor(s) by name and amount billed.



 


		9)	Other:
List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts
separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.


 


		(q)	Cost of Money (COM): Cite the COM factor and base
in effect during the time the cost was incurred and for which reimbursement is claimed.



 


		(r)	Indirect Costs: Identify the indirect cost base
(IDC), indirect cost rate, and amount billed for each indirect cost category.



 


		(s)	Fixed-Fee:
                                         Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee
                                         must be claimed as provided for by the contract. Note: If the contract provides
                                         for another type of Fee, i.e. Award or Incentive Fee, provide the same documentation
                                         for the amount claimed.



 


		(t)	Total Amounts Claimed: Insert the total amounts
claimed for the current and cumulative periods.



 


		(u)	Adjustments: Include amounts conceded by the Contractor,
outstanding suspensions, and/or disapprovals subject to appeal.



 




    	 	4	 



     


    

 


		(v)	Grand Totals



 


		(w)	Certification: The Contractor shall include the
following certification at the bottom of each payment request:



 


“Pursuant to authority vested in me, I certify
that this voucher is correct and proper for payment.”


 


Note: The contract may require additional
certifications (See Invoice Submission Instructions in Section G of the Contract Schedule)


 


The Contracting Officer may require the Contractor
to submit detailed support for costs claimed on one or more interim payment requests.


 


FINANCIAL REPORTING INSTRUCTIONS:


 


These instructions correspond to the Columns on the
Sample Invoice/Financing Request.


 


Column A - Expenditure Category: Enter the
expenditure categories required by the contract.


 


Column B - Cumulative Percentage of Effort/Hrs.
- Negotiated: Enter the percentage of effort or number of hours agreed to for each employee or labor category listed in Column
A.


 


Column C - Cumulative Percentage of Effort/Hrs.
- Actual: Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.


 


Column D - Amount Billed - Current: Enter
amounts billed during the current period.


 


Column E - Amount Billed - Cumulative: Enter
the cumulative amounts to date.


 


Column F - Cost at Completion: Enter data
only when the Contractor estimates that a particular expenditure category will vary from the amount negotiated. Realistic estimates
are essential.


 


Column G - Contract Amount: Enter the costs
agreed to for all expenditure categories listed in Column A.


 


Column H - Variance (Over or Under): Show
the difference between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made
in Column F. This column need not be filled in when Column F is blank. When a line item varies by plus or minus 10 percent, i.e.,
the percentage arrived at by dividing Column F by Column G, an explanation of the variance should be submitted. In the case of
an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost Clause in
the contract.


 


Modifications: List all new modification(s)
(not previously reported) in the amount negotiated for an item in the appropriate cost category.


 


Expenditures Not Negotiated: An expenditure for an
item for which no amount was negotiated (e.g., at the discretion of the Contractor in performance of its contract) should be listed
in the appropriate cost category and all columns filled in, except for G. Column H will of course show a 100 percent variance and
will be explained along with those identified under H above.


 




    	 	5	 



     


    

 


SAMPLE INVOICE/FINANCING
REQUEST AND CONTRACT FINANCIAL REPORT


	
        (a)     Designated Billing
        Office Name and Address:

        National Institutes of Health

        Office of Financial Management

        Commercial Accounts

        2115 East Jefferson Street, Room 4B432, MSC

        8500

        Bethesda, MD 20892-8500

         

        (b)     Contractor’s Name,
        Address, Point of Contact,

        TIN, and DUNS or DUNS+4 Number:

        ABC CORPORATION

        100 Main Street

        Anywhere, U.S.A. Zip+4

        Name, Title, Phone Number, and E-mail

        Address of Contractor’s Point of Contact.

        DUNS or DUNS+4:_____________________

        TIN:______________________________________
	
        (c) Invoice/Financing Request No.:__________

        (d) Date Invoice/Financing Request
        Prepared:

        _________________________________

        (e) Contract No. and Order No. (if
        applicable):

        _________________________________

        (f) Contract Title:

        _________________________________

        (g) Current Contract Period of
        Performance:

        _________________________________

        (h) Total Estimated Cost of
        Contract/Order:

        _________________________________

        (i) Total Fixed Fee (if applicable):___________

         

        (j) Two-Way Match:____

        Three-Way Match:_____

        (k) Office of Acquisitions:_________________

        (l) Central Point of Distribution:_____________



 


(m)
This invoice/financing request represents reimbursable costs for the period
from __________ to ________. 


	 	Cumulative % 

of Effort/Hrs	 	Amount Billed	 	 	 	 	 	 
	Expenditure Category*

 A	
        Neg.

        B
	 	
        Actual

        C
	 	
        (n)

        Current

        D
	 	
        (o)

        Cum

        E
	 	Cost at 

Comp 

F	 	
        Contract

        Value

        G
	 	
        Variance

        H

	(p) Direct Costs:	 	 	 	 	 	 	 	 	 	 	 	 	 
	(1) Direct Labor	 	 	 	 	 	 	 	 	 	 	 	 	 
	(2) Fringe Benefits __%	 	 	 	 	 	 	 	 	 	 	 	 	 
	(3) Accountable Property	 	 	 	 	 	 	 	 	 	 	 	 	 
	(4) Materials & Supplies	 	 	 	 	 	 	 	 	 	 	 	 	 
	(5) Premium Pay	 	 	 	 	 	 	 	 	 	 	 	 	 
	(6) Consultant Fees	 	 	 	 	 	 	 	 	 	 	 	 	 
	(7) Travel	 	 	 	 	 	 	 	 	 	 	 	 	 
	(8) Subcontracts	 	 	 	 	 	 	 	 	 	 	 	 	 
	(9) Other	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total Direct Costs	 	 	 	 	 	 	 	 	 	 	 	 	 
	(a) Cost of Money __%	 	 	 	 	 	 	 	 	 	 	 	 	 
	(r) Indirect Costs ___%	 	 	 	 	 	 	 	 	 	 	 	 	 
	(s) Fixed Fee ___%	 	 	 	 	 	 	 	 	 	 	 	 	 
	(t) Total Amount Claimed	 	 	 	 	 	 	 	 	 	 	 	 	 
	(u) Adjustments	 	 	 	 	 	 	 	 	 	 	 	 	 
	(v) Grand Totals	 	 	 	 	 	 	 	 	 	 	 	 	 


 


“Pursuant to authority vested in me, I certify that this voucher is correct and proper for payment.”


 


	 	 	 
	(Name of Official)	 	(Title)


 


*Attach details as specified in the contract or requested
by the Contracting Officer




 



    	 	6	 



     


    

 


 



     


    	09-25-0200 SYSTEMS LISTING	Page 1 of 10



    

 


09-25-0200 SYSTEMS
LISTING


 


SYSTEM NAME:


 


Clinical, Basic and Population-based Research Studies
of the National Institutes of Health (NIH), HHS/NIH/OD.


 


SECURITY CLASSIFICATION:


 


None.


 


SYSTEM LOCATION:


 


Records are located at NIH and Contractor research
facilities which collect or provide research data for this system. Contractors may include, but are not limited to: Research centers,
clinics, hospitals, universities, medical schools, research institutions/foundations, national associations, commercial organizations,
collaborating State and Federal Government agencies, and coordinating centers. A current list of sites, including the address of
any Federal Records Center where records from this system may be stored, is available by writing to the appropriate Coordinator
listed under Notification Procedure.


 


CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:


 


Adults and/or children who are
the subjects of clinical, basic, or population-based research studies of the NIH. Individuals with disease. Individuals who are
representative of the general population or of special groups including, but not limited to: normal controls, normal volunteers,
family members and relatives; providers of services (e.g., health care and social work); health care professionals and educators,
and demographic sub-groups as applicable, such as age, sex, ethnicity, race, occupation, geographic location; and groups exposed
to real and/or hypothesized risks (e.g., exposure to biohazardous microbial agents).


 


CATEGORIES OF RECORDS IN THE SYSTEM:


 


The system contains data about individuals as relevant
to a particular research study. Examples include, but are not limited to: name, study identification number, address, relevant
telephone numbers, social security number (voluntary), driver’s license number, date of birth, weight, height, sex, race; medical,
psychological and dental information, laboratory and diagnostic testing results; registries; social, economic and demographic data;
health services utilization; insurance and hospital cost data, employers, conditions of the work environment, exposure to hazardous
substances/compounds; information pertaining to stored biologic specimens (including blood, urine, tissue and genetic materials),
characteristics and activities of health care providers and educators and trainers (including curricula vitae); and associated
correspondence.


 


AUTHORITY FOR MAINTENANCE OF THE SYSTEM:


 


“Research and Investigation,”
“Appointment and Authority of the Directors of the National Research Institutes,” “National Cancer
Institute,” “National Eye Institute,” “National Heart, Lung and Blood Institute,” “National
Institute on Aging,” “National Institute on Alcohol Abuse and Alcoholism,” “National Institute on Allergy
and Infectious Diseases,” “National Institute of Arthritis and Musculoskeletal and Skin Diseases,”
“National Institute of Child Health and Human Development,” “National Institute on Deafness and Other
Communication Disorders,” “National Institute of Dental and Craniofacial Research,” “National Institute
of Diabetes, and Digestive and Kidney Diseases,” “National Institute of Drug Abuse,” “National Institute
of Environmental Health Sciences,” “National Institute of Mental Health,” “National Institute of
Neurological Disorders and Stroke,” and the “National Human Genome Research Institute” of the Public Health
Service Act. (42 U.S.C. 241,242,248,281, 282,284, 285a, 285b, 285c, 285d, 285e, 285f, 285g, 285h, 285i, 285j, 2851, 285m,
285n, 285o, 285p, 285q, 287, 287b, 287c, 289a, 289c, and 44 U.S.C. 3101.)


 


 Attachment 5


 



     


    	09-25-0200 SYSTEMS LISTING	Page 2 of 10



    

 


PURPOSE(S):


 


To document, track, monitor and evaluate NIH clinical, basic,
and population-based research activities.


 


ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING
CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:


 


1 .A re cord may be disclosed
for a research purpose, when the Department: (A) has determined that the use or disclosure does not violate legal or policy limitations
under which the record was provided, collected, or obtained; e.g., disclosure of alcohol or drug abuse patient records will be
made only in accordance with the restrictions of confidentiality statutes and regulations 42 U.S.C. 241,42 U.S.C. 290dd-2,42 CFR
Part 2, and where applicable, no disclosures will be made inconsistent with an authorization of confidentiality under 42 U.S.C.
241 and 42 CFR Part 2a; (B) has determined that the research purpose (1) cannot be reasonably accomplished unless the record is
provided in individually identifiable form, and (2) warrants the risk to the privacy of the individual that additional exposure
of the record might bring; (C) has required the recipient to (1) establish reasonable administrative, technical, and physical
safeguards to prevent unauthorized use or disclosure of the record, (2) remove or destroy the information that identifies the
individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research
project, unless the recipient has presented adequate justification of a research or health nature for retaining such information,
and (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of
any individual, (b) for use in another research project, under these same conditions, and with written authorization of the Department,
(c) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information
that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose
of the audit, or (d) when required by law; and (D) has secured a written statement attesting to the recipient’s understanding
of, and willingness to abide by, these provisions.


2.
Disclosure may be made to a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional
office made at the written request of the constituent about whom the record is maintained.


3. The Department of
Health and Human Services (HHS) may disclose information from this system of r ecords to the Department of Justice when: (a)
The agency or any component thereof; or (b) any employee of the agency in his or her official capacity where the Department
of Justice has agreed to represent the employee; or (c) the United States Government, is a party to litigation or has an
interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to
the litigation and the use of such records by the Department of Justice is, therefore, deemed by the agency to be for a
purpose that is compatible with the purpose for which the agency collected the records.


4. Disclosure may be
made to agency contractors, grantees, experts, consultants, collaborating researchers, or volunteers who have been engaged by
the agency to assist in the performance of a service related to this system of records and who need to have access to the
records in order to perform the activity. Recipients shall be required to comply with the requirements of the Privacy Act of
1974, as amended, pursuant to 5 U.S.C. 552a(m).


 



     


    	09-25-0200 SYSTEMS LISTING	Page 3 of 10



    

 


5. Information from this
system may be disclosed to Federal agencies, State agencies (including the


Motor Vehicle Administration and State vital statistics
offices, private agencies, and other third parties (such as current or prior employers, acquaintances, relatives), when necessary
to obtain information on morbidity and mortality experiences and to locate individuals for follow-up studies. Social security numbers,
date of birth and other identifiers may be disclosed: (1) to the National Center for Health Statistics to ascertain vital status
through the National Death Index; (2) to the Health Care Financing Agency to ascertain morbidities; and (3) to the Social Security
Administration to ascertain disabilities and/or location of participants. Social security numbers may also be given to other Federal
agencies, and State and local agencies when necessary to locating individuals for participation in follow-up studies.


6. Medical
information may be disclosed in identifiable form to tumor registries for maintenance of health statistics, e.g., for use in
research studies.


7. PHS may inform the
sexual and/or needle-sharing partner(s) of a subject individual who is infected with the human immunodeficiency virus (HIV) of
their exposure to HIV, under the following circumstances: (1) The information has been obtained in the course of clinical activities
at PHS facilities carried out by PHS personnel or contractors; (2) The PHS employee or contractor has made reasonable efforts to
counsel and encourage the subject individual to provide the information to the individual’s sexual or needle-sharing partner(s);
(3) The PHS employee or contractor determines that the subject individual is unlikely to provide the information to the sexual
or needle-sharing partner(s) or that the provision of such information cannot reasonably be verified; and (4) The notification
of the partner(s) is made, whenever possible, by the subject individual’s physician or by a professional counselor and shall follow
standard counseling practices.


 


PHS may disclose information to State or local
public health departments, to assist in the notification of the subject individual’s sexual and/or needle-sharing partner(s),
or in the verification that the subject individual has notified such sexual or needle-sharing partner(s). 


 


8. Certain disea ses
and conditions, including infectious diseases, may be reported to appropriate representatives of State or Federal Government
as required by State or Federal law.


9. Disclosure may be
made to authorized organizations which provide health services to subject individuals or provide third-party reimbursement or
fiscal intermediary functions, for the purpose of planning for or providing such services, billing or collecting third-party
reimbursements.


10.
The Secretary may disclose information to organizations deemed qualified to carry out quality assessment, medical audits or utilization
reviews.


11.
Disclosure may be made for the purpose of reporting child, elder or spousal abuse or neglect or any other type of abuse or neglect
as required by State or Federal law.


 


POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING,
RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:


 


STORAGE:


 


Records may be stored on index cards, file folders, computer
tapes and disks (including optical disks), photography media, microfiche, microfilm, and audio and video tapes. For certain studies,
factual data with study code numbers are stored on computer tape or disk, while the key to personal identifiers is stored separately,
without factual data, in paper/computer files.


 



     


    	09-25-0200 SYSTEMS LISTING	Page 4 of 10



    

 


RETRIEV ABILITY:


 


During data collection stages and follow-up, retrieval is
by personal identifier (e.g., name, social security number, medical record or study identification number, etc.). During the data
analysis stage, data are normally retrieved by the variables of interest (e.g., diagnosis, age, occupation).


 


SAFEGUARDS:


 


1. Authorized Users:
Access to identifiers and to link files is strictly limited to the authorized personnel whose duties require such access.
Procedures for determining authorized access to identified data are established as appropriate for each location. Personnel,
including contractor personnel, who may be so authorized include those directly involved in data collection and in the design
of research studies, e.g., interviewers and interviewer supervisors; project managers; and statisticians involved in
designing sampling plans. Other one-time and special access by other employees is granted on a need-to-know basis as
specifically authorized by the system manager. Researchers authorized to conduct research on biologic specimens will
typically access the system through the use of encrypted identifiers sufficient to link individuals with records in such a
manner that does not compromise confidentiality of the individual.


2. Physical
Safeguards: Records are either stored in locked rooms during off-duty hours, locked file cabinets, and/or secured computer
facilities. For certain studies, personal identifiers and link files are separated and stored in locked files. Computer data
access is limited through the use of key words known only to authorized personnel.


3. Procedural
Safeguards: Collection and maintenance of data is consistent with legislation and regulations in the protection of human
subjects, informed consent, confidentiality, and confidentiality specific to drug and alcohol abuse patients where these
apply. When anonymous data is provided to research scientists for analysis, study numbers which can be matched to personal
identifiers will be eliminated, scrambled, or replaced by the agency or contractor with random numbers which cannot be
matched. Contractors who maintain records in this system are instructed to make no further disclosure of the records. Privacy
Act requirements are specifically included in contracts for survey and research activities related to this system. The OHS
project directors, contract officers, and project officers oversee compliance with these requirements. Personnel having
access are trained in Privacy Act requirements. Depending upon the sensitivity of the information in the record, additional
safeguard measures may be employed.


4. Implementation
Guidelines: These practices are in compliance with the standards of Chapter 45- 13 of the HHS General Administration Manual,
“Safeguarding Records Contained in Systems of Records,” supplementary Chapter PHS hf: 45-13, and the HHS
Automated Information Systems Security Program Handbook.


 


RETENTION AND DISPOSAL:


 


Records are retained and disposed of under the authority
of the NIH Records Control Schedule contained in NIH Manual Chapter 1743, Appendix IB “Keeping and Destroying Records”
(HHS Records Management Manual, Appendix B-361), item 3000-G-3, which allows records to be kept as long as they are useful in
scientific research. Collaborative Perinatal Project records are retained in accordance with item 3000-G-4, which does not allow
records to be destroyed. Refer to the NIH Manual Chapter for specific conditions on disposal or retention instructions.


 


SYSTEM MANAGER(S) AND ADDRESS(ES):


 


See Appendix I for a listing of current System Managers.
This system is for use by all NIH Institutes and Centers.


 



     


    	09-25-0200 SYSTEMS LISTING	Page 5 of 10



    

 


NOTIFICATION PROCEDURE:


 


To determine if a record exists, write to the
appropriate IC Privacy Act Coordinator listed below. In cases where the requester knows specifically which System Manager to
contact, he or she may contact the System Manager directly (See Appendix I). Notification requests should include:
individual’s name; current address; date of birth; date, place and nature of participation in specific research study; name
of individual or organization administering the research study (if known); name or description of the research study (if
known); address at the time of participation; and in specific cases, a notarized statement (some highly sensitive systems
require two witnesses attesting to the individual’s identity). A requester must verify his or her identity by providing
either a notarization of the request or by submitting a written certification that the is who he or she claims to be and
understands that the knowing and willful request for acquisition of a record pertaining to an individual under false
pretenses is a criminal offense under the Act, subject to a five thousand dollar fine.


 


Individuals will be granted direct access to their
medical records unless the System Manager determines that such access is likely to have an adverse effect (i.e., could cause harm)
on the individual. In such cases when the System Manager has determined that the nature of the record information requires medical
interpretation, the subject of the record shall be requested to designate, in writing, a responsible representative who will be
willing to review the record and inform the subject individual of its contents at the representative’s discretion. The representative
may be a physician, other health professional, or other responsible individual. In this case, the medical/dental record will be
sent to the designated representative. Individuals will be informed in writing if the record is sent to the representative. This
same procedure will apply in cases where a parent or guardian requests notification of, or access to, a child’s or incompetent
person’s medical record. The parent or guardian must also verify (provide adequate documentation) their relationship to the child
or incompetent person as well as his or her own identity to prove their relationship.


 


If the requester does not know which Institute or
Center Privacy Act Coordinator to contact for notification purposes, he or she may contact directly the NIH Privacy Act Officer
at the following address: NIH Privacy Act Officer, Office of Management Assessment, 6011 Executive Blvd., Room 601L, Rockville,
MD 20852.


 


NIH Privacy Act Coordinators


 


Associate Director for Disease Prevention, Office
of the Director (OD), Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, Clinical Center (CC), Building
10, Room 1N208, 10 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Center for Complementary
and Alternative Medicine (NCCAM), Building 31, Room 2B11, 31 Center Drive, Bethesda, MD 20892-2182.


 


Privacy Act Coordinator, National Cancer Institute
(NCI), Building 31, Room 10A34, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Center on Minority
Health and Health Disparities (NCMHD), Democracy Plaza II, Room 800, 6707 Democracy Boulevard, Bethesda, MD 20892-5465.


 


Privacy Act Coordinator, National Center for Research
Resources (NCRR), Rockledge I, Room 5140, 6705 Rockledge Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Eye Institute
(NEI), Building 31, Room 6A32, 31 Center Drive, Bethesda, MD 20892-2510.


 



     


    	09-25-0200 SYSTEMS LISTING	Page 6 of 10



    

 


Privacy Act Coordinator, National Human Genome Research
Institute (NHGRI), Building 10, 3C710, 10 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Heart, Lung, and
Blood Institute (NHLBI), Building 31, Room 5 A3 3, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute on Aging
(NIA), Gateway Building 31, Room 2C234, 7201 Wisconsin Avenue, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute on Alcohol
Abuse and Alcoholism (NIAAA), Willco Building, Room 400, 6000 Executive Boulevard, Bethesda, MD 20892-7003.


 


Privacy Act Coordinator, National Institute of Allergy
and Infectious Diseases (NIAID), 6700-B Rockledge Drive, Room 2143, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS), Natcher Building, Room 5AS49, 45 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute of Biomedical
Imaging and Bioengineering (NIBIB), Building 31, Room 1B37, 31 Center Drive, Bethesda, MD 20892-2077.


 


Privacy Act Coordinator, National Institute of Child
Health and Human Development (NICHD), Building 31, Room 2A11, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, Office of Extramural Affairs,
National Institute on Drug Abuse (NIDA), Neuroscience Center, 6001 Executive Boulevard, Room 3158, Bethesda, MD 20892-9547.


 


Privacy Act Coordinator, National Institute on Deafness
and Other Communication Disorders (NIDCD), Building 31, Room 3C02, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute of Dental
and Craniofacial Research (NIDCR), Natcher Building, Room 4AS25, 45 Center Drive, Bethesda, MD 20892-6401.


 


Privacy Act Coordinator, National Institute of Diabetes
and Digestive and Kidney Disease (NIDDK), Building 31, Room 9A47, 31 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute of Environmental
Health Sciences (NIEHS), P.O. Box 12233, Research Triangle Park, NC 27709.


 


Privacy Act Coordinator, National Institute of General
Medical Sciences (NIGMS), Natcher Building, Room 2AN32, 45 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute of Mental
Health (NIMH), Neuroscience Center, 6001 Executive Boulevard, Room 8102, Bethesda, MD 20892.


 


Privacy Act Coordinator, National Institute of Neurological
Disorders and Stroke (NINDS), Building 31, Room 8A33, 31 Center Drive, Bethesda, MD 20892.


 



     


    	09-25-0200 SYSTEMS LISTING	Page 7 of 10



    

 


Privacy Act Coordinator, National Institute of Nursing
Research (NINR), Rockledge II, Room 710, 6701 Rockledge Drive, Bethesda, MD 20892.


 


RECORD ACCESS PROCEDURE:


 


Same as Notification Procedures. Requesters should
reasonably specify the record contents being sought. An individual may also request an accounting of disclosures of his/her record,
if any.


 


CONTESTING RECORD PROCEDURE:


 


Contact the appropriate official at the address specified
under Notification Procedure, and reasonably identify the record, specify the information being contested, and state corrective
action sought, with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.


 


RECORD SOURCE CATEGORIES:


 


The system contains information
obtained directly from the subject individual by interview (face-to-face or telephone), written questionnaire, or by other tests,
recording devices or observations, consistent with legislation and regulation regarding informed consent and protection of human
subjects. Information is also obtained from other sources, including but not limited to: referring medical physicians, mental health/alcohol/drug
abuse or other health care providers; hospitals; organizations providing biological specimens; relatives; guardians; schools; and
clinical medical research records.


 


SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE
ACT:


 


None.


 


Appendix I: System Manager(s) and Address(es)


 


Associate Director for Disease Prevention, Office
of the Director (OD), Building 1, Room 260, 1 Center Drive, Bethesda, MD 20892.


 


Computer Systems Analyst, Division of Cancer Treatment
and Diagnosis, National Cancer Institute (NCI), Executive Plaza North, Room 344, 6130 Executive Boulevard, Bethesda, MD 20892.


 


American Burkitt’s Lymphoma Registry, Division of
Cancer Etiology, National Cancer Institute (NCI), Executive Plaza North, Suite 434, 6130 Executive Boulevard, Bethesda, MD 20892.


 


Chief, Genetic Epidemiology
Branch, Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), Executive Plaza South, Room 7122, 6120 Executive
Boulevard, Bethesda, MD 20892- 7236.


 


Program Director, Research Resources, Biological
Carcinogenesis Branch, Division of Cancer Etiology, National Cancer Institute (NCI), Executive Plaza North, Room 540, 6130 Executive
Boulevard, Bethesda, MD 20892.


 


Chief, Environmental Epidemiology Branch, Division
of Cancer Etiology, National Cancer Institute (NCI), Executive Plaza North, Room 443,6130 Executive Boulevard, Bethesda, MD 20892.


 


Associate Director, Surveillance Program, Division
of Cancer Prevention, National Cancer Institute (NCI), Executive Plaza North, Room 343K, 6130 Executive Boulevard, Bethesda, MD
20892.


 



     


    	09-25-0200 SYSTEMS LISTING	Page 8 of 10



    

 


Head, Biostatistics and Data Management Section,
Center for Cancer Research, National Cancer Institute (NCI), Building 6116, Room 702, 6116 Executive Boulevard, Bethesda, MD 20892.


 


Chief, Clinical Research Branch, Center for Cancer
Research, Frederick Cancer Research and Development Center, National Cancer Institute (NCI), 501 W. 7th Street, Room 3, Frederick,
MD 21702.


 


Deputy Branch Chief, Navy Hospital, NCI-Naval Medical
Oncology Branch, Center for Cancer Research, National Cancer Institute (NCI), Building 8, Room 5101, Bethesda, MD 20814.


 


Chief, Pharmaceutical Management Branch, Cancer
Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), Executive Plaza
North, Room 804, 6130 Executive Boulevard, Bethesda, MD 20892.


 


Director, Extramural Clinical Studies, Frederick
Cancer Research and Development Center, National Cancer Institute (NCI), Fort Detrick, Frederick, MD 21702.


 


Clinical Operations Manager, National Eye Institute
(NEI), Building 10, Room 10S224, 10 Center Drive, Bethesda, MD 20892.


 


Director, Division of Biometry and Epidemiology,
National Eye Institute (NEI), Building 31, Room 6A52, 31 Center Drive, Bethesda, MD 20892.


 


Associate Director, Office of Clinical Affairs, National
Heart, Lung, and Blood Institute (NHLBI), Building 10, Room 8C104, 10 Center Drive, Bethesda, MD 20892-1754.


 


Senior Scientific Advisor, Office of the Director,
Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute (NHLBI), Federal Building, Room 220,
7550 Wisconsin Avenue, Bethesda, MD 20892.


 


Chief Laboratory of Epidemiology, Demography and
Biometry, National Institute on Aging (NIA), Gateway Building, Room 3C309, 7201 Wisconsin Avenue, Bethesda, MD 20892.


 


Chief, Research Resources Branch, Intramural Research
Program, National Institute on Aging (NIA), 5600 Nathan Shock Drive, Baltimore, MD 21224.


 


Clinical Director, National Institute on Aging (NIA),
5600 Nathan Shock Drive, Baltimore, MD 21224.


 


Deputy Director, Division of Biometry and Epidemiology,
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Willco Building, Room 514, 6000 Executive Boulevard, Bethesda, MD 20892-
7003.


 


Deputy Director, Division of
Clinical and Prevention Research, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Willco Building, Room 505, 6000 Executive
Boulevard, Bethesda, MD 20892-7003.


 


Chief, Respiratory Viruses Section, Laboratory of
Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), Building 7, Room 106,7 Memorial Drive, Bethesda,
MD 20892.


 



     


    	09-25-0200 SYSTEMS LISTING	Page 9 of 10



    

 


Chief, Hepatitis Virus Section,
Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), Building 7, Room 202,7 Memorial
Drive, Bethesda, MD 20892.


 


Chief, Biometry Branch, Division of Microbiology and
Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), 6700-B Rockledge Drive, Room 3120, Bethesda,
MD 20892.


 


Clinical Director, National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Building 10, Room 9S205,10 Center Drive, Bethesda, MD 20892.


 


Chief, Contracts Management Branch,
National Institute of Child Health and Human Development (NICHD), Executive Plaza North, Room 7A07, 6130 Executive Boulevard, Bethesda,
MD 20892.


 


Director of Intramural Research,
National Institute on Deafness and Other Communication Disorders (NIDCD), Building 31, Room 3C02, 31 Center Drive, Bethesda, MD
20892.


 


Chief, Scientific Programs Branch, National Institute
on Deafness and Other Communication Disorders (NIDCD), Executive Plaza South, Room 400C, 6120 Executive Boulevard, Bethesda, MD
20892-7180.


 


Clinical Director, National Institute of Dental and
Craniofacial Research (NIDCR), Building 10, Room INI 17,10 Center Drive, Bethesda, MD 20892-1191.


 


Chief, Scientific Review Branch,
National Institute of Dental and Craniofacial Research (NIDCR), Building 10, Room 1N117,10 Center Drive, Bethesda, MD 20892-1191.


 


Research Psychologist, Gene Therapy
and Therapeutics Branch, National Institute of Dental and Craniofacial Research (NIDCR), Building 10, Room 1N105,10 Center Drive,
Bethesda, MD 20892- 1190.


 


Chief, Clinical Investigations, National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), Building 10, Room 9N222,10 Center Drive, Bethesda, MD 20892.


 


Chief, Phoenix Clinical Research
Section, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix Area Indian Hospital, Room 541, 4212
North 16th Street, Phoenix, AZ 85016.


 


Chief, Diabetes Research Section,
Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Disease (NIDDK),
Natcher Building, Room 5AN18G, 45 Center Drive, Bethesda, MD 20892-6600.


 


Privacy Act Coordinator, Office of Extramural Affairs,
National Institute on Drug Abuse (NIDA), 6001 Executive Boulevard, Room 3158, Bethesda, MD 20892-9547.


 


Chief, Epidemiology Branch, National Institute of Environmental
Health Sciences (NIEHS), P.O. Box 12233, Research Triangle Park, NC 27709.


 


Director, Intramural Research Program, National Institute
of Mental Health (NIMH), Building 10, Room 4N224,10 Center Drive, Bethesda, MD 20892.


 


Privacy Act Coordinator, National
Institute of Mental Health (NIMH), Neuroscience Center, Room 8102,6001 Executive Boulevard, Bethesda, MD 20982.


 




     


    	09-25-0200 SYSTEMS LISTING	Page 10 of 10



    

 


Privacy Act Coordinator, National
Institute of Neurological Disorders and Stroke (NINDS), Building 31, Room 8A33, 31 Center Drive, Bethesda, MD 20892.


 


Chief, Epilepsy Branch, National
Institute of Neurological Disorders and Stroke (NINDS), Neuroscience Center, 6001 Executive Boulevard, Suite 2110, Bethesda, MD
20892-9523.


 


Assistant Director, Clinical Neurosciences
Program, Division of Intramural Research, National Institute of Neurological Disorders and Stroke (NINDS), Building 10, Room 5N234,10
Center Drive, Bethesda, MD 20892.


 


Acting Chief, Laboratory of Central
Nervous Systems Studies, Intramural Research Program, National Institute of Neurological Disorders and Stroke (NINDS), Building
36, Room 4A21, 36 Convent Drive, Bethesda, MD 20892-4123.


 


Clinical Director, National Human
Genome Research Institute (NHGRI), Building 10, Room 10C101D, 10 Center Drive, Bethesda, MD 20892.


 


Deputy Director, Division of Extramural Research, National
Institute of Neurological Disorders and Stroke (NINDS), Neuroscience Center, Room 3307, 6001 Executive Boulevard, Bethesda, MD
20892.


 


Director, Office of Clinical and Regulatory Affairs,
Division of Extramural Research and Training, Democracy Plaza II, Room 401,6707 Democracy Boulevard, Bethesda, MD 20892-5475.


 


Privacy Act Coordinator, National Institute of Biomedical
Imaging and Bioengineering (NIBIB), Building 31, Room 1B37,31 Center Drive, Bethesda, MD 20892-2077.


 


Privacy Act Coordinator, National Center on Minority
Health and Health Disparities (NCMHD), Democracy Plaza II, Room 800, 6707 Democracy Boulevard, Bethesda, MD 20892-5465.


 




     


     


    

 


RESEARCH PATIENT CARE COSTS — NIH(RC)-11


 


		(a)	Research patient care costs are the costs of routine and ancillary services provided to patients participating in research
programs described in this contract.



 


		(b)	Patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program
for determining the part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement
method used to determine the remaining portion of Medicare reimbursement shall not be used to determine patient care costs. Patient
care rates or amounts shall be established by the Secretary of HHS or his duly authorized representative.



 


		(c)	Prior to submitting an invoice for patient care costs under this contract, the contractor must make every reasonable effort
to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for patient care.



 


		(d)	The contractor must maintain adequate procedures to identify those research patients participating in this contract who are
eligible for third party reimbursement.



 


		(e)	Only those charges not recoverable from third party payors or patients and which are consistent with the terms and conditions
of the contract are chargeable to this contract.



 




    	NIH (RC)-11, Research Patient Care Costs	Page 1 of 1
	 	 
	 	Attachment 6



     


    

 


 



     


     


    

 


INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING
ACTIVITIES


 


This disclosure form shall be
completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is
required for each payment or agreementto make payment to any lobbying entity for influencing or attempting to influence an
officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employeeof a Member of
Congress in connection with a covered Federal action. Complete all items that apply for both the initial filing and material
change report. Refer to the implementing guidance published by the Office of Management and Budget for additional
information.


 


		1.	Identify the type of covered Federal action
for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.



 


		2.	Identify the status of the covered Federal
action.



 


		3.	Identify the appropriate classification
of this report. If this is a followup report caused by a material change to the information previously reported, enter the year
and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this
covered Federal action.



 


		4.	Enter the full name, address, city, State
and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classification of the reporting
entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the
first subawardee of the prime is the 1 st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards
under grants.



 


		5.	If the organization filing the report
in item 4 checks "Subawardee,"then enter the full name, address, city, State and zip code of the prime Federal recipient.
Include Congressional District, if known.



 


		6.	Enter the name of the Federal agency
                                                               making the award or loan commitment. Include at least one organizational level below agency name, if known. For example,
                                                               Department of Transportation, United States Coast Guard.



 


		7.	Enter the Federal program name or description
for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants,
cooperative agreements, loans, and loan commitments.



 


		8.	Enter the most appropriate Federal identifying
number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB)
number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number assigned
by the Federal agency). Include prefixes, e.g., "RFP-DE-90-001."



 


		9.	For a covered Federal action where there
has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime
entity identified in item 4 or 5.



 


		10.	(a) 	Enter the full name, address, city, State and zip code of the lobbying
registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered
Federal action.



 


		 	(b)	Enter the full names of the individual(s) performing services,
and include full address if different from 10 (a). Enter Last Name, First Name, and Middle Initial (Ml).



 


		11.	The certifying official shall sign and
date the form, print his/her name, title, and telephone number.



 


	According
    to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it
    displays a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046.
    Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time
    for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
    reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection
    of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction
    Project (0348-0046), Washington, DC 20503.


 




     


     


    

 


Schedule l-B


 


Contractor Acquired Government Property


 


	Biological Specimen Freezer (-80)	 	$	12,000	 
	(For purchase in Phase II)	 	 	 	 



 


Attachment 8


September 19, 2014


 




     


     


    

 


 



     


     


    

 


SBIR Funding Agreement Certification


 


Contract Number:


 


Program Director(s)/Principal Investigators)
(PD(s)/PI(s)):


 


All small businesses that are selected
for award of an SBIR funding agreement must complete this certification at the time of award and any other time set forth in the
contract that is prior to performance of work under this contract. This includes checking all of the boxes and having an authorized
officer of the contractor sign and date the certification each time it is requested.


 


Please read carefully the following
certification statements. The Federal government relies on this information to determine whether the business is eligible for a
Small Business Innovation Research (SBIR) Program award. A similar certification will be used to ensure continued compliance with
specific program requirements during the life of the funding agreement. The definitions for the terms used in this certification
are set forth in the Small Business Act, SBA regulations (13 C.F.R. Part 121), the SBIR Policy Directive and also any statutory
and regulatory provisions references in those authorities.


 


If the Contracting Officer believes
that the business may not meet certain eligibility requirements at the time of award, they are required to file a size protest
with the U.S. Small Business Administration (SBA), who will determine eligibility. At that time, SBA will request further clarification
and supporting documentation in order to assist in the verification of any of the information provided as part of a protest. If
the Contracting Officer believes, after award, that the business is not meeting certain contract requirements, the agency may request
further clarification and supporting documentation in order to assist in the verification of any of the information provided.


 


Even if correct information has been included in other
materials submitted to the Federal government, any action taken with respect to this certification does not affect the Government’s
right to pursue criminal, civil, or administrative remedies for incorrect or incomplete information given in the certification.
Each person signing this certification may be prosecuted if they have provided false information.


 


The undersigned has reviewed, verified
and certifies that (all boxes must be checked):


 


		1.	The business concern meets the ownership and control requirements set forth in 13 C.F.R. § 121.702.



x Yes
 ̈ No


 


		2.	If a corporation, all corporate documents (articles of incorporation and any amendments, articles of conversion, by-laws and
amendments, shareholder meeting minutes showing director elections, shareholder meeting minutes showing officer elections, organizational
meeting minutes, all issued stock certificates, stock ledger, buy-sell agreements, stock transfer agreements, voting agreements,
and documents relating to stock options, including the right to convert non-voting stock or debentures into voting stock) evidence
that it meets the ownership and control requirements set forth in 13C.F.R. § 121.702.



x Yes
 ̈ No  ̈ N/A Explain why N/A:


 


		3.	If a partnership, the partnership agreement evidences that it meets the ownership and control requirements set forth in 13
C.F.R. § 121.702.



x Yes
 ̈ No  ̈ N/A Explain why N/A: (LLC)


 


		4.	If a limited liability company, the articles of organization and any amendments, and operating agreements and amendments, evidence
that it meets the ownership and control requirements set forth in 13 C.F.R. §121.702.



x Yes
 ̈ No  ̈ N/A Explain why N/A:


 


		5.	The birth certificates, naturalization papers, or passports show that any individuals it relies upon to meet the eligibility
requirements are U.S. citizens or permanent resident aliens in the United States.



x Yes
 ̈ No  ̈ N/A Explain why N/A:


 




    	Attachment 10	Page 1



     


    

 


		6.	It has no more than 500 employees, including the employees of its affilliates.



x
Yes  ̈ No


 


		7.	SBA has not issued a size determination currently in effect finding that this business concern exceeds the 500 employee size
standard.



x Yes
 ̈ No


 


		8.	During the performance of the award, the principal investigator will spend more than half of his/her time as an employee of
die awardee or has requested and received a written deviation from this requirement from the Contracting Officer.



x Yes
 ̈ No        Deviation approved in writing by Contracting Officer:   %


 


		9.	All, essentially equivalent work, or a portion of the work proposed under this project (check the applicable line):



x
Has not been submitted for funding by another Federal agency.


 


 ̈
Has been submitted for funding by another Federal agency but has not been funded under any other Federal grant, contract,
subcontract, or other transaction.


 


 ̈
A portion has been funded by another grant, contract, or subcontract as described in detail in the proposal and approved in
writing by the Contracting Officer.


 


		10.	During die performance of award, it will perform die applicable percentage of work unless a deviation from this requirement
is approved in writing by the Contracting Officer (check the applicable line and fill in if needed):



 


x SBIR Phase
I: at least two-thirds (66 2/3%) of the research


 


x SBIR
Phase II: at least half (5 0%) of die research


 


 ̈
Deviation approved in writing by the Contracting Officer %


 


		11.	During performance of award, the research/research and development will be performed in the United States unless a deviation
is approved in writing by the Contracting Officer.



x Yes
 ̈ No


 


		12.	During the performance of award, the research/research and development will be performed at my facilities with my employees,
except as otherwise indicated in the SBIR proposal and approved in the Notice of Award



x Yes
 ̈ No


 


		13.	It has registered itself on SBA’s database as majority-owned by venture capital operating companies, hedge funds or private
equity firms.



 ̈ Yes
x No  ̈ N/A     Explain why N/A:


 


		14.	It is a Covered Small Business Concern (a small business concern that: (a) was not majority-owned by multiple venture capital
operating companies (VCOCs), hedge funds, or private equity firms on die data on which it submitted a proposal in response to an
SBIR solicitation; and (b) on the date of the SBIR award, which is made more than 9 months after the closing date of the solicitation,
is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms).



x Yes
 ̈ No


It will notify the Federal agency immediately if
all or a portion of the work proposed is subsequentiy funded by another Federal agency.


x Yes
 ̈ No


 




    	 	Page 2	SBIR Funding Agreement Certificate



     


    

 


I understand that the
information submitted may be given to Federal, State and local agencies for determining violations of law and other purposes.


 


I am an officer of
the business concern authorized to represent it and sign this certification on its behalf. By signing this certification, I am
representing on my own behalf, and on behalf of the business concern that the information provided in this certification, the
proposal, and all other information submitted in connection with this proposal is true and correct as of the date of submission.
I acknowledge that any intentional or negligent misrepresentation of the information contained in this certification may result
in criminal, civil or administrative sanctions, including but not limited to: (1) fines, restitution and/or imprisonment under
18 U.S.C. § 1001; (2) treble damages and civil penalties under the False Claims Act (31 U.S.C. § 3729 et seq); (3) double
damages and civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C. §380 1 et seq); (4) civil recovery of award
funds; (5) suspension and/or debarment from all Federal procurement and nonprocurement transactions (FAR Subpart 9.4 or 2 C.F.R.
part 180; and (6) other administrative penalties including termination of SBIR/STTR awards.


 


	Date 	9/19/2014


 


	Signature	/s/ ANATOLY DRITSCHILO


 


	Printed Name (First, Middle, Last) 	ANATOLY DRITSCHILO


 


	Title 	CEO


 


	Organization Name 	Shuttle Pharmaceuticals, LLC




 




    	 	Page 3	SBIR Funding Agreement Certificate



     


    

 


NIH Small
Business Innovation Research Program


Life Cycle Certification


 


All SBIR Phase I and Phase II Contractors must complete this certification
at all times set forth in the funding agreement (see § 8(h) of the SBIR Policy Directive). This includes checking all of the
boxes and having an authorized officer of the Contractor sign and date the certification each time it is required.


 


A certification is required at the following times:


 


		·	For SBIR Phase I Contractors: At the time of receiving
final payment or disbursement.



 


		·	For SBIR Phase II Contractors: prior to receiving more
than 50% of the total contract amount and prior to final payment or disbursement.



 


If the Contractor cannot complete this certification
or cannot ensure compliance with the certification process, it should notify the Contracting Officer immediately. If resolution
cannot be reached, the Contracting Officer will void or terminate the award, as appropriate.


 


Contract Number:


 


Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)):


 


Please read carefully the following certification statements. The
Federal government relies on the information to ensure compliance with specific program requirements during the life of the funding
agreement. The definitions for the terms used in this certification are set forth in the Small Business Act, the SBIR Policy Directive,
and also any statutory and regulatory provisions referenced in those authorities.


 


If the Contracting Officer believes that the
business is not meeting certain funding agreement requirements, the agency may request further clarification and supporting documentation
in order to assist in the verification of any of the information provided.


 


Even if correct information has been included in other materials
submitted to the Federal government, any action taken with respect to this certification does not affect the Government’s
right to pursue criminal, civil or administrative remedies for incorrect or incomplete information given in the certification.
Each person signing this certification may be prosecuted if they have provided false information.


 


The undersigned has reviewed, verified and certifies that (all
boxes must be checked):


 


		1.	The principal investigator spent more than one half of
his/her time as an employee of the Contractor or has requested and received a written deviation from this requirement from the
Contracting Officer.



 


 ̈
Yes  ̈ No Deviation approved in writing by Contracting
Officer:________%


 


		2.	All, essentially equivalent work, or a portion of the work
performed under this project (check the applicable line):



 


 ̈ Has
not been submitted for funding by another Federal agency.


  




    	Attachment 11	Page 1



     


    

 


 ̈
Has been submitted for funding by another Federal agency but has not been funded under any other Federal grant, contract,
subcontract, or other transaction.


 


 ̈
A portion has been funded by another grant, contract, or subcontract as described in detail in the proposal and approved
in writing by the Contracting Officer.


 


		3.	Upon completion of the contract it will have performed
the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Contracting Officer
(check the applicable line and fill in if needed):



 


 ̈
SBIR Phase I: at least two-thirds (66 2/3%) of the research


 


 ̈
SBIR Phase II: at least half (50%) of the research


 


 ̈
Deviation approved in writing by the Contracting Officer:     %


 


		4.	The work is completed and it has performed the applicable
percentage of work, unless a deviation from this requirement is approved in writing by the Contracting Officer (check the applicable
line and fill in if needed).



 


 ̈
SBIR Phase I: at least two-thirds (66 2/3%) of the research


 


 ̈
SBIR Phase II: at least half (50%) of the research


 


 ̈
Deviation approved in writing by the Contracting Officer:     %


 


 ̈
N/A because work is not completed


 


		5.	The research/research and development is performed in the
United States unless a deviation is approved in writing by the Contracting Officer.



 


 ̈
Yes  ̈ No Waiver has been granted


 


		6.	The research/research and development is performed at my
facilities with my employees, except as otherwise indicated in the SBIR proposal and approved in the contract.



 


 ̈
Yes  ̈ No


 


 ̈
I will notify the Federal agency immediately if all or a portion of the work proposed is subsequently funded by another Federal
agency.


 


 ̈
I understand that the information submitted may be given to Federal, State and local agencies for determining violations of law
and other purposes.


 


 ̈
I am an officer of the business concern authorized to represent it and sign this certification on its behalf. By signing this certification,
I am representing on my own behalf, and on behalf of the business concern that the information provided in this certification,
the proposal, and all other information submitted in connection with the award, is true and correct as of the date of submission.
I acknowledge that any intentional or negligent misrepresentation of the information contained in this certification may result
in criminal, civil or administrative sanctions, including but not limited to: (1) fines, restitution and/or imprisonment under
18 U.S.C. § 1001; (2) treble damages and civil penalties under the False Claims Act (31 U.S.C. § 3729 et seq.); (3) double
damages and civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C. §3801 et seq.); (4) civil recovery of award
funds; (5) suspension and/or debarment from all Federal procurement and nonprocurement transactions (FAR Subpart 9.4 or 2 C.F.R.
part 180); and (6) other administrative penalties including termination of SBIR/STTR awards.


 




    	 	Page 2



     


    

 


	Date	 
	Signature	 
	Printed
    Name (First, Middle, Last)	 
	Title	 
	Business
    Name	 


 




    	 	Page 3



     


    

 


 


 



     


     


    

 


BEGINNING
WITH THE EFFECTIVE DATE OF THIS MODIFICATION, THE GOVERNMENT AND THE CONTRACTOR MUTUALLY AGREE AS FOLLOWS:


 


ARTICLE
B.3. OPTION FOR PHASE II subparagraph d is revised as follows:


 


d.
If the Government exercises its option pursuant
to the OPTION PROVISION Article in SECTION H of this contract, the Government’s total estimated contract amount represented
by the sum of the estimated cost plus the fixed fee will be increased as follows:


 


	 	 	Estimated
 Cost($)	 	 	Fixed Fee($)	 	 	Estimated Cost Plus Fixed
 Fee($)	 
	Base Period 
9/19/2014 - 8/03/2015	 	$	181,105	 	 	$	10,866	 	 	$	191,971	 
	Option Period: 
8/04/2015 - 8/03/2017	 	$	1,347,280	 	 	$	80,837	 	 	$	1,428,117	 
	Total [Base Period and Option]	 	$	1,528,385	 	 	$	91,703	 	 	$	1,620,088	 




 


ARTICLE
B.4. ADVANCE UNDERSTANDINGS, subparagraph b., is revised as follows:


 


b.
Subcontract


 


A
fixed type subcontract with Rhode Island Hospital for Phase I for an amount not to exceed $65,549 for the period for the period
9/19/2014-8/03/2015.


 


If
the Government exercises its option for Phase II pursuant to the Option Provision Article in Section H of this contract, the total
estimated Subcontract amount will be increased as follows:


 


Option
- 8/04/2015-8/03/2017 - $623,269


 


ARTICLE
F.1. PERIOD OF PERFORMANCE- is revised as follows:


 


a.
The period of performance of this contract shall
be from 09/19/2014 through 08/03/2017.


 


b.
If the Government exercises its option 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
	Option for Phase II	 	August 04, 2015 - August 03, 2017




 




    	Shuttle Pharmaceuticals, LLC
HHSN261201400013C
Modification 2
	2 of 6



     


    

 


ARTICLE F.2. DELIVERIES-subparagraph b is revised as follows:


 


b. The above items shall be addressed and emailed to ncibranchbinvoices@mail.nih.gov
..The following addresses are provided for general correspondence and other deliveries:


 


	Addressee	 	Deliverable Item No	 	Quantity
	
        Sandra Addae, Contract Specialist National Cancer Institute Office
        of Acquisitions,

        9609 Medical Center Drive,

        Room 1E632

        MSC 9705

        Bethesda, MD 20892-9705
	 	1-14, 16-21	 	Electronically
	 	 	 	 	 
	Deepa Narayanan, COR National Cancer Institute NCI SBIR & STTR Programs, Room1W5429609 Medical Center Drive, MSC9705Bethesda, MD 20892-9705	 	2-12	 	Electronically
	 	 	 	 	 
	OPERA, OEH, NIH6705 Rockledge DriveSuite 310, MSC 7980Bethesda, Maryland 20892-7980	 	13-15	 	Electronically




 


ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND
CONTRACT FINANCIAL REPORT - 2.f. and 2.h are revised as follows:


 


2. f. The contract period of performance is: 9/19/2014 - 08/03/2017


 


2. h. Contract line items as follows:


 


	Line
    Item #	 	Line
    Item Description
	1	 	Clinical Development of IPdR for Radiosensitization
	2	 	Phase II Clinical Development of IPdR for
    Radiosensitization




 


ARTICLE
I.1. GENERAL CLAUSES FOR A FIXED-PRICE RESEARCH AND DEVELOPMENT SBIR PHASE II CONTRACT- is deleted and replaced in its entirety.


 


This contract
incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request,
the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically as
follows: FAR Clauses at: http://www.acquisition.gov/far/ .
HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html


 




    	Shuttle Pharmaceuticals, LLC
HHSN261201400013C
Modification 2
	3 of 6



     


    

 


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


 


	
        FAR

        CLAUSE NO.
	 	DATE	 	TITLE
	52.202-1	 	Nov 2013	 	Definitions (Over the Simplified Acquisition
    Threshold)
	52.203-3	 	Apr 1984	 	Gratuities (Over the Simplified Acquisition
    Threshold)
	52.203-5	 	May 2014	 	Covenant Against Contingent Fees (Over the
    Simplified Acquisition Threshold)
	52.203-6	 	Sep 2006	 	Restrictions on Subcontractor Sales to the
    Government (Over the Simplified Acquisition Threshold)
	52.203-7	 	May 2014	 	Anti-Kickback Procedures (Over the Simplified
    Acquisition Threshold)
	52.203-8	 	May 2014	 	Cancellation, Rescission, and Recovery of
    Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
	52.203-10	 	May 2014	 	Price or Fee Adjustment for Illegal or Improper
    Activity (Over the Simplified Acquisition Threshold)
	52.203-12	 	Oct 2010	 	Limitation on Payments to Influence Certain
    Federal Transactions (Over $150,000)
	52.203-17	 	Apr 2014	 	Contractor Employee Whistleblower Rights
    and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
	52.203-99	 	Feb 2015	 	Prohibition on Contracting with Entities
    That Require Certain Internal Confidentiality Agreements
	52.204-4	 	May 2011	 	Printed or Copied Double-Sided on Postconsumer
    Fiber Content Paperf(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)
	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
	52.219-6	 	Jul 1996	 	Notice of Total Small Business Set-Aside




 




    	Shuttle Pharmaceuticals, LLC
HHSN261201400013C
Modification 2
	4 of 6



     


    

 


	
        FAR

        CLAUSE NO.
	 	DATE	 	TITLE
	52.219-8	 	Oct 2014	 	Utilization of
    Small Business Concerns (Over the Simplified Acquisition Threshold)
	52.219-14	 	Dec 1996	 	Limitations on
    Subcontracting
	52.222-3	 	Jun 2003	 	Convict Labor
	52.222-21	 	Apr 2015	 	Prohibition of
    Segregated Facilities
	52.222-26	 	Apr 2015	 	Equal Opportunity
	52.222-35	 	Jul 2014	 	Equal Opportunity
    for Veterans ($100,000 or more)
	52.222-36	 	Jul 2014	 	Equal Opportunity
    for Workers with Disabilities
	52.222-37	 	Jul 2014	 	Employment Reports
    on Veterans ($100,000 or more)
	52.222-40	 	Dec 2010	 	Notification
    of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)
	52.222-50	 	Mar 2015	 	Combating Trafficking
    in Persons
	52.222-54	 	Aug 2013	 	Employment Eligibility Verification (Over
    the Simplified Acquisition Threshold)
	52.223-6	 	May 2001	 	Drug-Free Workplace
	52.223-18	 	Aug 2011	 	Encouraging Contractor
    Policies to Ban Text Messaging While Driving
	52.225-1	 	May 2014	 	Buy American
    - Supplies
	52.225-13	 	Jun 2008	 	Restrictions
    on Certain Foreign Purchases
	52.227-1	 	Dec 2007	 	Authorization
    and Consent, Alternate  I (Apr 1984)
	52.227-2	 	Dec 2007	 	Notice and Assistance
    Regarding Patent and Copyright Infringement
	52.227-11	 	May 2014	 	Patent Rights
    - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements
    in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
	52.227-20	 	May 2014	 	Rights in Data
    - SBIR Program
	52.229-3	 	Feb 2013	 	Federal, State
    and Local Taxes (Over the Simplified Acquisition Threshold)
	52.232-2	 	Apr 1984	 	Payments under
    Fixed-Price Research and Development Contracts
	52.232-9	 	Apr 1984	 	Limitation on
    Withholding of Payments
	52.232-17	 	May 2014	 	Interest (Over
    the Simplified Acquisition Threshold)
	52.232-23	 	May 2014	 	Assignment of
    Claims
	52.232-25	 	Jul 2013	 	Prompt Payment
	52.232-33	 	Jul 2013	 	Payment by Electronic
    Funds Transfer-System for Award Management
	52.232-39	 	Jun 2013	 	Unenforceability
    of Unauthorized Obligations
	52.233-1	 	May 2014	 	Disputes
	52.233-3	 	Aug 1996	 	Protest After
    Award
	52.233-4	 	Oct 2004	 	Applicable Law
    for Breach of Contract Claim
	52.242-13	 	Jul 1995	 	Bankruptcy (Over
    the Simplified Acquisition Threshold)
	52.243-1	 	Aug 1987	 	Changes - Fixed
    Price, Alternate V (Apr 1984)
	52.244-5	 	Dec 1996	 	Competition in
    Subcontracting (Over the Simplified Acquisition Threshold)
	52.244-6	 	Apr 2015	 	Subcontracts
    for Commercial Items
	52.249-2	 	Apr 2012	 	Termination for
    the Convenience of the Government (Fixed-Price)
	52.249-9	 	Apr 1984	 	Default (Fixed-Price
    Research and Development)(Over the Simplified Acquisition Threshold)




 




    	Shuttle Pharmaceuticals, LLC
HHSN261201400013C
Modification 2
	5 of 6



     


    

 


	
        FAR 

        CLAUSE NO.
	 	DATE
	 	TITLE
	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
	352.203-70	 	Mar 2012	 	Anti-Lobbying
	352.222-70	 	Jan 2010	 	Contractor Cooperation in Equal Employment
    Opportunity Investigations
	352.227-70	 	Jan 2006	 	Publications and Publicity
	352.231-71	 	Jan 2001	 	Pricing of Adjustments
	352.242-70	 	Jan 2006	 	Key Personnel
	352.242-73	 	Jan 2006	 	Withholding of Contract Payments




 


[End of GENERAL CLAUSES FOR
A FIXED-PRICE RESEARCH AND DEVELOPMENT SBIR PHASE II CONTRACT- Rev. 04/2015].


 


All
other terms and conditions of this contract remain unchanged and in full force and effect.


 




    	Shuttle Pharmaceuticals, LLC
HHSN261201400013C
Modification 2
	6 of 6