Exhibit
10.5


 





 






    	 



    	 



    

 


 






    	 



    	 



    

 


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-



    	 



    

 


	 	 	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



 






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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-



    	 



    

 


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
    
[Base Period and Option]	 	$	1,528,385	 	 	$	91,703	 	 	$	1,620,088	 



 


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-



    	 



    

 


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, Commercialization Consultant, Phase II	 	$	200	 	 	 	100	 	 	$	20,000	 



 


	 	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/qrants/quide/notice-files/NQT- 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-



    	 



    

 


ARTICLE
B.5. PROVISIONS APPLICABLE TO DIRECT COSTS


 


	 	a.
  	Items
  Unallowable Unless Otherwise Provided




 


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


 


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



 




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	 	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_VendorJs 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-



    	 



    

 


	 	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-



    	 



    

 


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-



    	 



    

 


	 	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-



    	 



    

 


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-



    	 



    

 


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-



    	 



    

 


	 	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.gov/cqi-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.gov/web/508/contracting/technology/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-



    	 



    

 


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)(H))
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-



    	 



    

 


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-



    	 



    

 


	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/IRB 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-



    	 



    

 


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.acguisition.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-



    	 



    

 


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 (#, $, %,*, &, I) 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 Radiosensitization_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-



    	 



    

 


	 	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-



    	 



    

 


	 	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/loqisticsmanual/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-



    	 



    

 


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-



    	 



    

 


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:


 


httD://grants.nih.qov/qrants/guide/notice-files/NOT-OD-OQ-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-



    	 



    

 


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://qrants.nih.gov/grants/guide/notice-files/not98-Q84.html


http://grants.nih.gov/grants/guide/notice-files/not99-1Q7.html


http://grants.nih.gov/grants/guide/notice-files/NQT-QD-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/ getdoc.cgiVdbname^HO
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-Q33.html.


 




    	-24-



    	 



    

 


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)j. 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)


 




    	-25-



    	 



    

 


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


 


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


 


ARTICLE
H.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-



    	 



    

 


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.qov/. The complete text of Section 508 Final provisions can be accessed at
    http://www.access-board.gov/quidelines-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/technoloqy/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)j


 


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-



    	 



    

 


	 	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&S I D=0af84ca649a74846f 102aaf664da 1623&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.


 




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


 




    	-29-



    	 



    

 


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-



    	 



    

 


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-



    	 



    

 


PART
II - CONTRACT CLAUSES


 


SECTION
I - CONTRACT CLAUSES


 


ARTICLE
1.1. 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/nolicies/hhsar/subr)art352.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 1 (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

    



 




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	FAR
    

CLAUSE NO.	 	DATE	 	TITLE

    

	 	 	 	 	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
	52.232-23	 	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-



    	 



    

 


ARTICLE
1.1. 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


 




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	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	 	Jut
    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 1 (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 1 (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


 




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	FAR
    

CLAUSE NO.	 	DATE	 	TITLE
	52.233-3	 	Aug
    1996	 	Protest
    After Award, Alternate 1 (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	 	Jul1995	 	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].


 




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ARTICLE
1.2. AUTHORIZED SUBSTITUTION OF CLAUSES


 


ARTICLE
1.1. 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-



    	 



    

 


ARTICLE
1.3. 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.oDm.ciov/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-



    	 



    

 


ARTICLE
1.4. 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-



    	 



    

 


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://qrants.nih.qov/qrants/fundinq/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.


 


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


 


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


 




    	-40-



    	 



    

 


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)


 




    	-41-



    	 



    

 


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 ILIdR (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 l and PK clinical trial to design the Phase IB/II 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/II protocol for
efficacy determination. 


 


Milestone 3.2. Write Phase IB/II 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.


 


	Site	Milestones
    and Deliverables	Delivery
    Schedule (months)
	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/II 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, NIHfRC)-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.


 









    	NIH(RC)-2
Revised 7/2013
	 
Attachment 2




    	1



    

 


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.
	 	 
	(l)	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.

                                                                              

	 	 
	(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.


 






    	NIH(RC)-2
Revised 7/2013
	 





    	2



    

 


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).



 






    	NIH(RC)-4
Revised 7/2013
	 





    	1



    

 


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.


 






    	NIH(RC)-4
Revised 7/2013
	 





    	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.
	 	 
	(l)	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.



 



    	NIH(RC)-4
Revised 7/2013
	 





    	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.



 



    	NIH(RC)-4
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	(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.


 



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SAMPLE
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT


 





	(a)	Designated Billing Office Name and Address: 

National Institutes of Health	(c)	Invoice/Financing Request No.:_________
	 	Office of Financial Management

Commercial Accounts	(d)	
    Date Invoice/Financing Request Prepared:

     _________________________________

	 	
    2115 East Jefferson Street, Room 4B432, MSC 8500

    Bethesda, MD 20892-8500
	(e)	
    Contract No. and Order No. (if applicable):

     __________________

	 	 	(f)	
    Contract Title:

     __________________

	(b)	Contractor’s Name, Address, Point of Contact, TIN, and DUNS or DUNS+4 Number:	(g)	
    Current Contract Period of Performance:

    ___________________

	 	 	(h)	
    Total Estimated Cost of Contract/Order:

     _________________________________

	 	
    ABC CORPORATION

    100 Main Street
	(i)	
    Total Fixed Fee (if applicable):___________

     

	 	
    Anywhere, U.S.A. Zip+4

    Name, Title, Phone Number, and E-mail
	(j)	
    Two-Way Match:_____

    Three-Way Match:_______

     

	 	Address of Contractor’s Point of Contact.	(k)	Office of Acquisitions:_________________
	 	DUNS or DUNS+4: ________________	 	 
	 	TIN:_____________________________________	(l)	Central Point 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	 	 	 	 	 	 	 
	(q)
    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 


 






    	NIH(RC)-4
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Cumulative
Inclusion Enrollment Report


 


This
report format should NOT be used for collecting data from study participants.


 



Study
Title:


 


Comments:


	 	Ethnic
    Categories	Total
	Racial
    Categories	Not
    Hispanic or Latino	Hispanic
    or Latino	Unknown/Not
    Reported Ethnicity
	Female	Male	Unknown/

    

    Not

    

    Reported
	Female	Male	Unknown/

    

    Not

    

    Reported
	Female	Male	Unknown/
                                            

    Not

    

    Reported

	American
    Indian/ Alaska Native	 	 	 	 	 	 	 	 	 	0
	Asian	 	 	 	 	 	 	 	 	 	0

	Native
    Hawaiian or Other Pacific islander	 	 	 	 	 	 	 	 	 	0

	Black
    or African American	 	 	 	 	 	 	 	 	 	0
	White	 	 	 	 	 	 	 	 	 	0
	More
                                            Than One

     

    Race
	 	 	 	 	 	 	 	 	 	0

	Unknown
    or Not Reported	 	 	 	 	 	 	 	 	 	0

	Total	0	0	0	0	0	0	0	0	 	0


 


PHS
398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015)


 


OMB
No. 0925-0001/0002 

Cumulative Inclusion Enrollment Report


 


Page


 



    	 



    	 



    




 


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.


 






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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.)


 


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.	Are 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 records 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).



 






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	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
    diseases 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.


 


RETRIEVABILITY:


 


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).


 



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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.


 




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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 10A3 4, 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.


 




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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.


 




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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.


 




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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 8004,10 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.


 




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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 INI 17,10 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.


 


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.


 




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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 contracto r must make every reasonable effort to obtain
    third party payment, where third party payors (including Government agencies) are authorized or are under a legal ob ligation 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




    	4/1/84	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 agreement to 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 employee of 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) (For purchase in Phase II)	 	$12,000





 




    	 



    	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 die 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 fall boxes must be checked):


 


	 	1.	The
    business concern meets the ownership and control requirements set forth in 13 C.F.R. § 121.702.
	 	 	 
	 	 	☒
    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.
	 	 	 
	 	 	☒
    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. ,
	 	 	 
	 	 	☒
    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.
	 	 	 
	 	 	☒
    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 toe United States. 
	 	 	 
	 	 	☒
    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 affiliates.
	 	 	 
	 	 	☒
    Yes ☐ No
	 	 	 
	 	7.	SBA
    has not issued a size determination currently in effect finding that this business concern exceeds the 500 employee size standard.
	 	 	 
		 	☒
    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 the awardee
    or has requested and received a written deviation from this requirement from the Contracting Officer.
	 	 	 
	 	 	☒
    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):

                                                                                 

	 	 	☒
    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
    the performance of award, it will perform 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):
	 	 	 
	 	 	☒
    SI SBIR Phase I: at least two-thirds (66 2/3%) of the research
	 	 	 
	 	 	☒
    SBIR Phase II: at least half (5 0%) of the 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.
	 	 	 
	 	 	☒
    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. 
	 	 	 
	 	 	☒
    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 ☒ 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 the 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).
	 	 	☒
    Yes ☐ No
	 	 	 
	 	 	It
    will notify the Federal agency immediately if all or a portion of the work proposed is subsequently funded by another Federal agency.
	 	 	☒
    Yes ☐ No


 


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 die 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	
	 	 
	Printed
    Name (First, Middle, Last)	ANATOLY
    DRITSCHILO
	 	 
	Title	CEO
	 	 
	Organization
    Name	Shuttle
    Pharmaceuticals, LLC





 






    	Page 1	SBIR Funding Agreement Certification




    	 



    

 


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 Investigators) (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.


 


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


 




    

    		Page 2