Exhibit
10.17


 








 






    	 	 	 



    	 



    

 


CONTRACT TABLE OF CONTENTS


 




	PART
    I - THE SCHEDULE	3
	SECTION
    B - SUPPLIES OR SERVICES AND PRICES/COSTS	3
	ARTICLE
    B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES	3
	ARTICLE
    B.2. PRICES	3
	ARTICLE
    B.3. ADVANCE UNDERSTANDINGS	3
	SECTION
    C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT	4
	ARTICLE
    C.1. STATEMENT OF WORK	4
	ARTICLE
    C.2. REPORTING REQUIREMENTS	4
	ARTICLE
    C.3. INVENTION REPORTING REQUIREMENT	8
	SECTION
    D - PACKAGING, MARKING AND SHIPPING	8
	SECTION
    E - INSPECTION AND ACCEPTANCE	9
	SECTION
    F - DELIVERIES OR PERFORMANCE	9
	ARTICLE
    F.1. Estimated Completion Date	9
	ARTICLE
    F.2. DELIVERIES	9
	ARTICLE
    F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)	10
	SECTION
    G - CONTRACT ADMINISTRATION DATA	10
	ARTICLE
    G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)	10
	ARTICLE
    G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)	11
	ARTICLE
    G.3. INVOICE SUBMISSION	11
	ARTICLE
    G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (December 2013)	12
	ARTICLE
    G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE	13
	SECTION
    H - SPECIAL CONTRACT REQUIREMENTS	13
	ARTICLE
    H.1. HUMAN SUBJECTS	13
	ARTICLE
    H.2. HUMAN MATERIALS	13
	ARTICLE
    H.3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY	13
	ARTICLE
    H.4. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM
    NIH-FUNDED RESEARCH	14
	ARTICLE
    H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING	14
	ARTICLE
    H.6. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)	14
	ARTICLE
    H.7. ANIMAL WELFARE	15
	ARTICLE
    H.8. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS	15
	ARTICLE
    H.9. GUN CONTROL	16
	ARTICLE
    H.10. LIMITATIONS ON SUBCONTRACTING - SBIR	16
	ARTICLE
    H.11. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTSOF INTEREST	16
	ARTICLE
    H.12. PUBLICATION AND PUBLICITY	17
	ARTICLE
    H.13. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	17
	ARTICLE
    H.14. SHARING RESEARCH DATA	18
	PART
    II - CONTRACT CLAUSES	18
	SECTION
    I - CONTRACT CLAUSES	18
	PART
    III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS	21
	SECTION
    J - CONTRACT CLAUSES	21
	1.
    Statement of Work	21
	2.
    Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2	21
	3. Safety
    and Health	21
	4. Disclosure
    of Lobbying Activities, SF-LLL	22
	5. NIH
    Small Business Innovation Research (SBIR) Program Funding Agreement Certification	22
	6.
    NIH Small Business Innovation Research (SBIR) Program Life Cycle Certification	22
	PART
    IV· REPRESENTATIONS AND INSTRUCTIONS	22
	SECTION
    K ·REPRESENTATIONS AND CERTIFICATIONS	22
	1.
    Annual Representations and Certifications	 
	2.
    Annual Representations and Certifications, FAR Clause 52.204-8	 
	3.
    Animal Welfare Assurance Number	 


 






    	 	-2-	 



    	 



    

 





PART
I-THE SCHEDULE


 


SECTION
B - SUPPLIES OR SERVICES AND PRICES/COSTS


 


ARTICLE
B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES


 


Topic
352 - Cell-Based Models for Prostate Cancer Health Disparity Research:


 


This
Phase II SBIR effort will complete tasks to meet four objectives to establish 50 prostate cancer cell lines for commercialization for
health disparities research. Objective 1 is to establish 25 prostate paired epithelial cancer and normal cell lines from AA prostate
surgical specimens and 25 prostate epithelial cancer cell lines from targeted needle biopsies (product#1). In objective 2, paired tumor/normal
micro-arrays will be designed and manufactured (product#2). In objective 3, proprietary, supplemented conditioned medium will be manufactured
for growing AA prostate cancer cells (product #3). In objective 4, a plan will be advanced to commercialize and market the AA derived
prostate cancer cells and related products for health disparities research.


 


ARTICLE
B.2. PRICES


 





	 	a.	The
                                            total fixed price of this contract is $1,484,350.
	 	 	 
	 	b.	Upon
                                            delivery and acceptance of the services described in SECTION C of this contract and identified
                                            in the schedule of charges below, the Government shall pay to the Contractor the unit price(s)
                                            set forth below:



 


PAYMENT
SCHEDULE


 


	Description	 	Amount
    ($)	 
	Kick-Off Presentation	 	$	164,927	 
	Quarterly Report 1	 	$	164,927	 
	Quarterly Report 2	 	$	164,927	 
	Quarterly Report 3	 	$	164,927	 
	Quarterly Report 4, SBIR Program Life Cycle
    Certification, 
Annual Updated Commercialization Plan	 	$	164,927	 
	Quarterly Report 5	 	$	164,927	 
	Quarterly Report 6	 	$	164,927	 
	Quarterly Report 7	 	$	164,927	 
	Final Report, Contract Outcomes Report, Final
    presentation, and all other contract deliverables	 	$	164,934	 
	TOTAL FIXED PRICE	 	$	1,484,350	 



 





ARTICLE
B.3. ADVANCE UNDERSTANDINGS


 


		a.	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:


 





HHS
Contract Number: HHSN261201800016C


 


UPIID:
75N91018C00016


 




    	 	-3-	 



    	 



    

 


		b.	SBIR
                                            Funding Agreement Certification



 


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


 


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


 


SECTION
C - DESCRIPTIONZSPECIFICATIONSZWORK 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, dated September 17, 2018, set forth in SECTION
                                            J-List of Attachments, attached hereto and made a part of this contract.



 


ARTICLE
C.2. REPORTING REQUIREMENTS


 


All
reports required herein shall be submitted in electronic format via e-mail, as attachments, to the following designated NCI Branch Distribution
Mailbox: NCIbrancheinvoices@mail.nih.gov.


 


Each
e-mail 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 e-mail shall read as follows: Deliverable- Contract Number_ Vendor’s Name_ Deliverable Description-
Due Date.


 


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


 


		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:
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. Slides shall be prepared and presentation of the slides shall occur either
in-person or through webinar or teleconference. The presentation shall cover the following:


 


	 	a.	Discussion of the Contractor’s
    organization and project status, particularly changes that occurred since the proposal submission;


 




    	 	-4-	 



    	 



    

 





	 	b.	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
    the proposed project is 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 Reports


 


The
Contractor shall submit Quarterly Reports, which shall include:


 


		a.	Summary
                                            of technical objectives with status of each objective clearly marked ( e.g. previously
                                            completed, completed during this 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.



 


This
report shall generally be no longer than five (5) pages, excluding tables, figures, images and graphs used to present data.


 


3.
Annual 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 Phases II and 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.


 




    	 	-5-	 



    	 



    

 


	 	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.


 


	 	e.	Finance Plan







 


Describe
the necessary financing the Contractor will require to commercialize the innovation 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.


 


4.
Draft Final Report


 





The
Contractor shall submit a Draft Final Report. The Government Contracting Officer’s Representative (COR) will review and provide
comments on the Draft Final Report, which the Contractor shall incorporate into a revised Final Report (- see Reporting Requirement Item
5).


 


The
Draft Final Report shall include the following three sections:


 


Section
1: Summary of Salient Results


 


The
Summary of Salient Results shall summarize in 200 words or less the salient results achieved during performance of the contract.


 




    	 	-6-	 



    	 



    

 


Section
2: Final Technical Report


 


The
Final Technical Report shall set forth the work performed and results obtained for the entire contract period of performance. This report
shall be in sufficient detail to describe comprehensively the results achieved.


 


Section
3: Commercialization Plan


 


The
Commercialization Plan shall be in the same format as described above for the Annual Updated Commercialization Plan (- see Reporting
Requirement Item 3).


 


5.
Final Report





 


The
Contractor shall submit a Final Report. This document shall incorporate revisions in response to the comments provided by the Government
COR after review of the Draft Final Report (- see Reporting Requirements Item 4).


 


6.
Contract Outcomes Report


 





The
Contractor shall submit a Contract Outcomes Report using a fillable PDF form to be provided by the Government. The Contract Outcomes
Report must be provided as a filled-in version of the PDF form provided and not as a printed or scanned copy of this document.


 


7.
Final Presentation


 





The
Contractor shall prepare and submit a final presentation. Slides shall be prepared and presentation of the slides shall occur either
in-person or through webinar or teleconference. The presentation shall cover the following:


 


		a.	Discussion
                                            of the Contractor’s organization and project status;
	 	 	 
		b.	Contractor’s
                                            achievements during the 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 progress towards commercialization;
	 	 	 
		f.	Questions
                                            to the NCI.






 


	 	b.	Other Reports/Deliverables




 


1.
Reporting of Financial Conflict of Interest (FCOI)


 





All
reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI
Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic
format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.


 


45
CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx? c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rqn=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.


 




    	 	-7-	 



    	 



    

 


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


 


2. 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 ward 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://qrants.nih.gov/grants/guide/ notice-files/NOT-OD-13-116.html.


 


ARTICLE
C.3. INVENTION REPORTING REQUIREMENT


 


A
‘subject invention’ is defined as “any invention of the contractor made in the performance of work under a Government
contract.” See FAR 27.301.


 


All
reports and documentation required for subject inventions 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).


 


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 required 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.


 


In
addition, a final invention statement, listing all subject inventions or stating that there were none, shall be submitted to the Contracting
Officer and the Contracting Officer’s Representative (COR) on or before the completion date of the contract.


 


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.


 




    	 	-8-	 



    	 



    

 


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) designated
                                            in SECTION G is the authorized representative of the Contracting Officer.
	 	 	 
	 	c.	Inspection
                                            and acceptance will be performed at:



 


National
Cancer Institute


9609
Medical Center Drive


Rockville,
MD 20850


 


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 clauses by reference, with the same force and effect
                                            as if 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).


 


SECTION
F - DELIVERIES OR PERFORMANCE


 


ARTICLE
F.1. Estimated Completion Date


 


The
estimated completion date of this contract is September 16, 2020.


 


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 date(s) specified below:



 


	Item	 	Description	 	Delivery
    Schedule
	 	 	 	 	 
	(1)	 	SBIR
    Funding Agreement Certification	 	Due
    at time of award, prior to performance of any work under this contract.
	(2)	 	Kick-off
    Presentation	 	Due
    on or before 30 calendar days following the effective date of this contract.
	(3)	 	Quarterly
    Reports	 	Due
                                            on or before 15 calendar days following completion of each reporting period.

    A
    Quarterly Report shall not be due when the Final Report is due.

	(4)	 	SBIR
    Program Life Cycle Certification 1	 	Due
    upon submission of invoice requesting at least 50% of the total fixed price.


 




    	 	-9-	 



    	 



    

 


	Item	 	Description	 	Delivery
    Schedule
	 	 	 	 	 
	(5)	 	Annual
    Updated Commercialization Plan	 	Due
    on or before 1 year after the effective date of this contract.
	(6)	 	Draft
    Final Report	 	Due
    on or before 1 month prior to the completion date of the contract.
	(7)	 	Final
    Report	 	Due
    on or before the completion date of the contract.
	(8)	 	Contract
    Outcomes Report	 	Due
    on or before the completion date of the contract.
	(9)	 	Final
    Presentation	 	Due
    on or before the completion date of the contract.
	(W)	 	SBIR
    Program Life Cycle Certification 2	 	Due
    on or before the completion date of the contract.
	(11)	 	Final
    Invention Statement	 	Due
    on or before the completion date of the contract.
	(12)	 	Financial
    Conflict of Interest Reports	 	In
    accordance with 45 CFR Part 94.
	(13)	 	Invention
                                            Disclosure Report &

    Annual
    Invention Utilization Reports
	 	In
    accordance with FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor, for any subject invention(s).


 





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


 


	Addressee	 	Deliverables
	NCI
    Contracting Officer ncibrancheinvoices@mail.nih.gov	 	Items
    1-12, in electronic format
	OPERA,
                                            OEH, NIH

    6705
    Rockledge Drive, Suite 310, MSC 7980

    Bethesda,
    MD 20892-7980
	 	Item
    13. via http://www.iedison.qov


 


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:
https://www.acquisition.qov/?q=browsefar.


 


FEDERAL
ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE: 52.242-15, Stop Work Order (August 1989).


 


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:


 


Dr.
Xiang-Jian Lou


 


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.


 




    	 	-10-	 



    	 



    

 


ARTICLE
G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)


 


The
key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor
voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer
and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify
the proposed replacement and provide an explanation of how the replacement’s skills, experience, and credentials meet or exceed
the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor
is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide
the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key
personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary
to reflect the agreement of the parties.


 


(End
of Clause)


 


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


 


	Name	 	Title
	Scott
    Grindrod, PhD	 	Principal
    Investigator


 


ARTICLE
G.3. INVOICE SUBMISSION


 


	a.	Invoice
                                            Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, 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_lnvoice number (e.g., if you are submitting Invoice 123456, save the
                                            single attachment as “Contractor Namejnvoice 123456”).
	 	 	 
	 	 	[Note:
                                            Please do not use special characters (such as #, $, %, *, &, I) when saving your attachment.
                                            Only the underscore symbol (_) is permitted.]



 










    	 	-11-	 



    	 



    

 





		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 E - ncibrancheinvoices@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.
	 	 	 
	 	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.



 





		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 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. 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 System for Award Management (SAM) 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. 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.
	 	 	 
		g.	The
                                            contract number designations identified in Article B and the contract title.



 


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



 


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)


 




    	 	-12-	 



    	 



    

 


ARTICLE
G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE


 


	a.	Contractor Performance Evaluations







 


Interim
and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance
evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared
Annually, on or around the anniversary of the effective date of the contract.


 


Interim
and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will
be permitted sixty 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. HUMAN SUBJECTS


 


It
is hereby understood and agreed that research involving human subjects shall not be conducted under this contract, and that no material
developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will
be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic
use involving humans without the prior written approval of the Contracting Officer.


 


ARTICLE
H.2. HUMAN MATERIALS


 


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


 


ARTICLE
H.3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY


 


Contractors
shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the
policy in performance of the Statement of Work and in publications, as applicable:


 


1)
Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key
Biological and/or Chemical Resources. This policy applies to all NIH funded research and development, from basic through advanced clinical
studies. See NIH Guide Notice, NQT-QD-15-103. “Enhancing Reproducibility through Rigor and Transparency” and NOT-OD-15-1Q2,
“Consideration of Sex as a Biological Variable in NIH-funded Research” for more information. In addition, publications
are expected to follow the guidance at http:// www.nih.gov/research-traininq/riqor-reproducibility/principles-guidelines-reporting-preclinical-research.
whether preclinical or otherwise, as appropriate. More information is available at http://grants.nih.gov/reproducibility/index.htm.
including FAQs and a General Policy Overview.


 




    	 	-13-	 



    	 



    

 





ARTICLE
H.4. 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.qov/grants/quide/notice-files/NOT-OD-09-Q71.html and http:// publicaccess.nih.gov.


 


ARTICLE
H.5. 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.6. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)


 


	a.	Before
                                            undertaking performance of any contract involving animal-related activities where the species
                                            is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register
                                            with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and
                                            9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the
                                            Contracting Officer.
	 	 
	b.	The
                                            Contractor shall acquire vertebrate animals used in research from a dealer licensed by the
                                            Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is
                                            exempt from licensing under those sections.
	 	 
	c.	The
                                            Contractor agrees that the care, use, and intended use of any live vertebrate animals in
                                            the performance of this contract shall conform with the Public Health Service (PHS) Policy
                                            on Humane Care and Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance
                                            (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press,
                                            Washington, DC) and the pertinent laws and regulations of the United States Department of
                                            Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict
                                            between standards, the more stringent standard shall govern.
	 	 
	d.	If
                                            at any time during performance of this contract, the Contracting Officer determines, in consultation
                                            with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH),
                                            that the Contractor is not in compliance with any of the requirements and standards stated
                                            in paragraphs (a) through (c)above, the Contracting Officer may immediately suspend, in whole
                                            or in part, work and further payments under this contract until the Contractor corrects the
                                            noncompliance. Notice of the suspension may be communicated by telephone and confirmed in
                                            writing. If the Contractor fails to complete corrective action within the period of time
                                            designated in the Contracting Officer’s written notice of suspension, the Contracting
                                            Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part,
                                            and the Contractor’s name may be removed from the list of those contractors with Animal
                                            Welfare Assurances.



 








Note:
The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the
Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the
appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff,
USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email: ace@aphis.usda.qov; Web site: ( http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).


 


(End
of clause)


 




    	 	-14-	 



    	 



    

 


ARTICLE
H.7. ANIMAL WELFARE


 


All
research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and
Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http:// qrants1.nih.gov/qrants/olaw/references/phspol.htm


 


In
addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate
Animal Section (VAS) of the contractor’s technical proposal, as modified in the Final Proposal Revision (FPR), dated July 31,2018,
which is incorporated by reference.


 


ARTICLE
H.8. 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.9. GUN CONTROL


 


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


 


ARTICLE
H.10. LIMITATIONS ON SUBCONTRACTING - SBIR


 


The
Contractor shall perform a minimum of one-half of the research and/or analytical effort conducted under this contract, as measured by
total contract dollars. Any deviation from this requirement must be approved in writing by the Contracting Officer.


 


ARTICLE
H.11. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST


 


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


 


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




 


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




 




    	 	-15-	 



    	 



    

 


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




 


		Significant financial
  interests do not include the following:




 





	 	1.	Income
                                            from seminars, lectures, or teaching, and service on advisory or review panels for government
                                            agencies, Institutions of higher education, academic teaching hospitals, medical centers,
                                            or research institutes with an Institution of higher learning; and
	 	2.	Income
                                            from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator
                                            does not directly control the investment decisions made in these vehicles.



 


	 	b.	Require each Investigator to complete training regarding
  the Institution’s financial conflicts of interest policy prior to engaging in research related to any NIH-funded contract and
  at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators,
  consultants or subcontractors comply with the regulations.
	 	 	 
	 	c.	Designate
                                            an official(s) to solicit and review disclosures of significant financial interests from
                                            each Investigator who is planning to participate in, or is participating in, the NIH-funded
                                            research.
	 	 	 
	 	d.	Require
                                            that each Investigator who is planning to participate in the NIH-funded research disclose
                                            to the Institution’s designated official(s) the Investigator’s significant financial
                                            interest (and those of the Investigator’s spouse and dependent children) no later than
                                            the date of submission of the Institution’s proposal for NIH- funded research. Require
                                            that each Investigator who is participating in the NIH-funded research to submit an updated
                                            disclosure of significant financial interests at least annually, in accordance with the specific
                                            time period prescribed by the Institution during the period of the award as well as within
                                            thirty days of discovering or acquiring a new significant financial interest.
	 	 	 
	 	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.



 




    	 	-16-	 



    	 



    

 


	 	i.	Establish
                                            adequate enforcement mechanisms and provide for employee sanctions or other administrative
                                            actions to ensure Investigator compliance as appropriate.
	 	 	 
	 	j.	Complete
                                            the certification in Section K - Representations, Certifications, and Other Statements of
                                            Offerors titled “Certification of Institutional Policy on Financial Conflicts of Interest”.



 


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


 


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


 


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


 


ARTICLE
H.12. 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. HHSN261201800016C”


 


	a.	Advanced Copies of Press Releases




 


Press
releases shall be considered to include the public release of information to any medium, excluding peer- reviewed scientific publications.
The Contractor shall not publish a press release related to this contract without receiving prior concurrence from the Contracting Officer.
The Contractor shall submit an advance copy of the press release to the Contracting Officer and Contracting Officer’s Representative
(COR). Upon acknowledgment of receipt, the Contracting Officer will have five (5) working days to respond with concurrence or comments.
In the event that the Contracting Officer does not communicate concurrence or comments to the Contractor within five (5) working days
following acknowledgement of receipt of the press release advance copy, concurrence may be presumed.


 


ARTICLE
H.13. 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://oiq.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


 




    	 	-17-	 



    	 



    

 


ARTICLE
H.14. SHARING RESEARCH DATA


 


The
Contractor agrees to adhere to the data sharing plan submitted with its final proposal revision and shall request prior approval of the
Contracting Officer for any changes in its plan.


 


The
NIH endorses the sharing of final research data to serve health. This contract is expected to generate research data that must be shared
with the public and other researchers. NIH’s data sharing policy may be found at the following Web site: http://qrants.nih.gov/grants/quide/notice-files/NOT-OD-03-Q32.html.


 


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


 


PART
II - CONTRACT CLAUSES


 


SECTION
I - CONTRACT CLAUSES


 


ARTICLE
1.1. GENERAL CLAUSES FOR A FIXED-PRICE RESEARCH AND DEVELOPMENT 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: htto://www, acquisition, oov/far/. HHSAR Clauses at: http:// www. hhs. gov/policies/hhsar/suboart352. 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)


 






    	 	-18-	 



    	 



    

 


	FAR
                                            CLAUSE NO.
	 	DATE	 	TITLE
	52.203-12	 	Oct
    2010	 	Limitation
    on Payments to Influence Certain Federal Transactions (Over $150,000)
	52.203-17	 	Apr
    2014	 	Contractor
    Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
	52.203-99	 	Feb
    2015	 	Prohibition
    on Contracting with Entities That Require Certain Internal Confidentiality Agreements (DEVIATION)
	52.204-4	 	May
    2011	 	Printed
    or Copied Double-Sided on Postconsumer Fiber Content PaperfOver the Simplified Acquisition Threshold)
	52.204-10	 	Oct
    2016	 	Reporting
    Executive Compensation and First-Tier Subcontract Awards ($30,000 or more)
	52.204-13	 	Oct
    2016	 	System
    for Award Management Maintenance
	52.209-6	 	Oct
    2015	 	Protecting
    the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $35,000)
	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 $750,000)
	52.215-12	 	Oct
    2010	 	Subcontractor
    Cost or Pricing Data (Over $750,000)
	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 $750,000)
	52.215-18	 	Jul
    2005	 	Reversion
    or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
	52.215-19	 	Oct
    1997	 	Notification
    of Ownership Changes
	52.215-21	 	Oct
    2010	 	Requirements
    for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications
	52.219-6	 	Nov
    2011	 	Notice
    of Total Small Business Set-Aside
	52.219-8	 	Nov
    2016	 	Utilization
    of Small Business Concerns (Over the Simplified Acquisition Threshold)
	52.219-14	 	Jan
    2017	 	Limitations
    on Subcontracting
	52.222-3	 	Jun
    2003	 	Convict
    Labor
	52.222-21	 	Apr
    2015	 	Prohibition
    of Segregated Facilities
	52.222-26	 	Sep
    2016	 	Equal
    Opportunity
	52.222-35	 	Oct
    2015	 	Equal
    Opportunity for Veterans ($150,000 or more)
	52.222-36	 	Jul
    2014	 	Equal
    Opportunity for Workers with Disabilities
	52.222-37	 	Feb
    2016	 	Employment
    Reports on Veterans ($150,000 or more)
	52.222-40	 	Dec
    2010	 	Notification
    of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)
	52.222-50	 	Mar
    2015	 	Combating
    Trafficking in Persons
	52.222-54	 	Oct
    2015	 	Employment
    Eligibility Verification (Over the Simplified Acquisition Threshold)


 




    	-19-



     


    

 


	FAR
    CLAUSE NO.	 	DATE	 	TITLE
	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
	52.229-3	 	Feb
    2013	 	Federal,
                                            State and Local Taxes (Over the Simplified Acquisition

    Threshold)

	52.232-2	 	Apr
    1984	 	Payments
    under Fixed-Price Research and Development Contracts
	52.232-9	 	Apr
    1984	 	Limitation
    on Withholding of Payments
	52.232-17	 	May
    2014	 	Interest
    (Over the Simplified Acquisition Threshold)
	52.232-23	 	May
    2014	 	Assignment
    of Claims
	52.232-25	 	Jan
    2017	 	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 A ward
	52.233-4	 	Oct
    2004	 	Applicable
    Law for Breach of Contract Claim
	52.242-13	 	Jul
    1995	 	Bankruptcy
    (Over the Simplified Acquisition Threshold)
	52.243-1	 	Aug
    1987	 	Changes
    - Fixed Price, Alternate V (Apr 1984)
	52.244-5	 	Dec
    1996	 	Competition
    in Subcontracting (Over the Simplified Acquisition Threshold)
	52.244-6	 	Nov
    2017	 	Subcontracts
    for Commercial Items
	52.246-25	 	Feb
    1997	 	Limitation
    of Liability - Services (Over the Simplified Acquisition Threshold)
	52.249-2	 	Apr
    2012	 	Termination
    for the Convenience of the Government (Fixed-Price)
	52.249-9	 	Apr
    1984	 	Default
    (Fixed-Price Research and Development)(Over the Simplified Acquisition Threshold)
	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
	352.203-70	 	Dec
    2015	 	Anti-Lobbying
	352.222-70	 	Dec
    2015	 	Contractor
    Cooperation in Equal Employment Opportunity Investigations
	352.227-70	 	Dec
    2015	 	Publications
    and Publicity
	352.237-75	 	Dec
    2015	 	Key
    Personnel


 


[End
of GENERAL CLAUSES FOR A FIXED-PRICE RESEARCH AND DEVELOPMENT SBIR PHASE II CONTRACT- Rev. 11/2017].


 




    	-20-



     


    

 


ARTICLE
1.2. AUTHORIZED SUBSTITUTION OF CLAUSES


 


ARTICLE
1.1. of this SECTION is hereby modified as follows:


 


	 	a.	THERE ARE NO APPLICABLE CLAUSES
  IN THIS SECTION.




 


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 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
	 	 	 
	 	2.
    	FAR
    Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations (November 2015).
	 	 	 
	 	3.
    	FAR
    Clause 52.219-28, Post-Award Small Business Program Rerepresentation (July 2013).



 


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




 


	 	1.	HHSAR Clause 352.208-70,
  Printing and Duplication (December 2015)
	 	 	 
	 	2.	HHSAR Clause 352.223-70,
  Safety and Health (December 2015)




 


PART
III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS


 


SECTION
J - LIST OF ATTACHMENTS


 


The
following documents are attached and incorporated in this contract:


 


1.
Statement of Work


 


Statement
of Work, dated September 17, 2018, 4 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.
Safety and Health


 


Safety
and Health, HHSAR Clause 352.223-70, (12/15), 2 pages.


 




    	-21-



     


    

 


4.
Disclosure of Lobbying Activities, SF-LLL


 


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


 


5.
NIH Small Business Innovation Research (SBIR) Program Funding Agreement Certification


 


NIH
Small Business Innovative Research (SBIR) Program Funding Agreement Certification, 3 pages, located at: http://grants.nih.qov/grants/funding/sbir_forms/SBlR%20Fundinq%20Agreement%20Certification.pdf.


 


6.
NIH Small Business Innovation Research (SBIR) Program Life Cycle Certification


 


NIH
Small Business Innovative Research (SBIR) Program Life Cycle Certification, 3 pages, located at: http:// grants.nih.gov/grants/funding/sbir_forms/SBIR%20Life%20Cycle%20Certification.pdf.


 


PART
IV - REPRESENTATIONS AND INSTRUCTIONS


 


SECTION
K - REPRESENTATIONS AND CERTIFICATIONS


 


The
following documents are incorporated by reference in this contract:


 


	 	1.	FAR
  Clause 52.204-19 Incorporation by Reference of Representations and Certifications (December 2014)




 


The
Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM),
are incorporated by reference into the contract.


 


(End
of clause)


 


	 	2.	NIH Representations &
  Certifications, dated January, 2017
	 	 	 
	 	3.	Animal Welfare Assurance
  Number A8433-02.




 


END
of the SCHEDULE


 


(CONTRACT)


 




    	-22-



     


    

 


STATEMENT
OF WORK (Phase II Topic 352)


 


TITLE:
Cell-Based Models for Prostate Cancer Health Disparity Research


 


Background
Information


 


	I.	Prostate cancer health disparities
  studies have shown that African-American (AA) men are at higher risk for developing prostate cancer, as well as at higher risk of cancer
  specific death rates, as compared to Caucasian American (CA) men. Causes of disparities have been attributed to socioeconomic differences,
  environmental exposures and biological factors; however, the lack of relevant in vitro and in vivo models has limited biological and
  mechanistic studies. In the Phase I SBIR contract effort, we completed feasibility studies of establishing annotated, same donor cancer
  and normal prostate epithelial cell lines from an AA patient. We developed standard operating procedures and reagents for establishing
  cancer and normal prostate epithelial cell lines using “conditional reprogramming cell (CRC)” technology. In this Phase
  II SBIR contract application, we propose to establish prostate epithelial cancer cell lines from 50 AA patients to serve as the product
  for commercialization for use in health disparities research. Furthermore, a niche marketing assessment and negotiations with Propagenix,
  Inc. to license the CRC intellectual property supports the development of a commercialization plan for AA cell distribution and reagent
  marketing.
	 	 
	II.	Scope




 


Prostate
cancer and normal epithelial cell lines will be established from 50 African- American patients presenting with prostate cancer for use
in health disparities research.


 


	III.	Objectives




 


This
Phase II SBIR effort will complete tasks to meet four objectives to establish 50 prostate cancer cell lines for commercialization for
health disparities research. Objective 1 is to establish 25 prostate paired epithelial cancer and normal cell lines from AA prostate
surgical specimens and 25 prostate epithelial cancer cell lines from targeted needle biopsies (product#1). In objective 2, paired tumor/normal
micro-arrays will be designed and manufactured (product#2). In objective 3, proprietary, supplemented conditioned medium will be manufactured
for growing AA prostate cancer cells (product #3). In objective 4, a plan will be advanced to commercialize and market the AA derived
prostate cancer cells and related products for health disparities research.


 


	IV.	Services to be Performed.




 


“The
contractor shall independently perform all work and furnish all labor, materials, supplies, equipment, and services (except as otherwise
specified in the contract) to perform the following services:”


 


	A.	Specific Requirements.




 


Objective
1. Obtain tissues to establish prostate epithelial tumor and normal cell cultures from 50 African-American patients (product #1).


 


Rationale,
Overview and Methodologies: We have demonstrated that biopsies from prostatectomy specimens may be sampled in regions with normal
appearance as well as regions deemed abnormal by an experienced pathologist. We have expanded the epithelial cells using CRC technology.
In this first objective, biopsy samples from 25 African -American patients


will be grown to establish paired normal and tumor derived cells. Furthermore, patients undergoing prostatectomy are generally low to
intermediate risk, yielding tumors from cancers with predominantly Gleason’s grades 6 and 7. Patients presenting with high risk
cancers with higher Gleason’s grades (8-10) and PSA values exceeding 20 ng/dl are frequently biopsied and offered hormonal and/or
radiation therapy options. The CRC technology is capable of establishing cell growth from needle biopsies with as few as 5,000 cells.
We propose to apply targeted biopsy technology to establish cell lines from these higher-grade, more aggressive tumors, or from metastatic
lesions in soft tissues to expand the range of tumor aggressiveness of AA-derived prostate cancers. Matched normal cells may not be available
in some cases.


 





	Attachment
    1: Statement of Work	Page
    1 of 4
	Dated:
    September 17, 2018 	 
	HHSN261201800016C	 


 




    	 



    	 



    

 


Task
1.1. Acquire tissues from 25 radical prostatectomy specimens from AA patients and grow cells under CRC conditions.


Milestone
1.1. 25 tumor and normal prostate epithelial cell cultures from prostatectomy specimens from AA patients.


 


Task
1.2. Acquire tissues from 25 AA patient undergoing targeted needle biopsies. 


Milestone 1.2. 25 tumor and normal prostate epithelial
cell cultures from prostate needle biopsy specimens from AA patients.


 


Task
1.3. Perform characterization and annotation studies, including clinical annotation, cell growth > 30 passages, capacity to form
xenograft tumors, karyotype at early and late passages, microarray analysis for differential gene expression in cells in 2D and 3D cultures,
expression of prostate tissue and tumor specific markers, STR analysis, and mycoplasma testing.


Milestone
1.3. Clinical and biological annotations of AA cells are available.


 


Task
1.4. Establish and expand (up to 30 passages) paired tumor/normal stock cell cultures derived from AA patients with prostate cancers.


Milestone
1.4. 50 annotated cell cultures from AA patients (product #1).


 


Task
1.5. Perform Q/A testing for immortalization of cells during extended growth by growing cells in medium, without the use of irradiated
feeder layer cells, and growing cells in an immune deficient animal to form tumors.


Milestone
1.5. Established cultures will be annotate for immortal or tumorigenic cell growth.


 


Objective
2. Design and manufacture paired tumor/normal micro-arrays (product #2).


 


Rationale,
Overview and Methodologies: The focus on personalized medicine in cancer treatment has been to discover and apply predictive biomarkers
in directing targeted therapy. The use of tissue micro-arrays (TMAs) offers a screen for understanding the relevant molecular pathways.
The use of cells for drug candidate screening offers an efficient and cost effective assay to discover new therapeutics. Here we propose
to manufacture TMAs from our annotated prostate epithelial cell culture.


 


Task
2.1. Based on prostate epithelial cell annotation data, design tissue microarrays (TMAs) for AA cells based on groupings of cells
by site of derivation (normal vs tumor), annotation parameters of Gleason’s grades, tumor growth in animals, early passage vs late
and selected tumor specific markers.


Milestone
2.1. At least three categories for grouping cells are identified for TMA manufacture in sets of 12 tumor cell lines and associated
normal.


 


Task
2.2. Manufacture TMAs from AA cells.


Milestone
2.2. Stock of representative TMAs for each of the selected categories of AA cells (product #2).


 


	Attachment
    1: Statement of Work	Page
    2 of 4
	Dated:
    September 17, 2018 	 
	HHSN261201800016C	 


 




    	 



    	 



    

 


Objective
3. Manufacture proprietary, supplemented conditioned medium for growing AA prostate cancer cells (product #3).


 


Rationale,
Overview and Methodologies. The use of the CRC technology requires technical experience, manpower, access to an irradiator and has
a learning curve for staff for optimal implementation. Through our previous efforts to optimize the media for use with prostate epithelial
cells, we observed that conditioned medium with supplements permitted expansion of 5,000 prostate epithelial cells to > 1,000,000.
Since establishing the full scale CRC technology includes potential barriers for some investigators, here we propose to provide reagents
for use for more focused experiments with proprietary medium for selected AA prostate cell lines.


 


Task
3.1. Manufacture conditioned medium formulated to support AA prostate cell growth.


Milestone
3.1. Stock of 100 ml vials of proprietary conditioned medium for AA cells (product #3).


 


Task
3.2. Test AA prostate cell growth in proprietary conditioned medium and select best growing cells for marketing in combination
with the proprietary conditioned medium.


Milestone
3.2. Stock of AA cells capable of growth in proprietary conditioned medium.


 


Objective
4. Advance the business development and commercialization plan for company sustainability and AA cell distribution and sales.


 


Rationale,
Overview and Methodologies.


 


Task
4.1. Complete licensing agreement with Propagenix for CRC technology to establish and commercialize AA cells for research use.


Milestone
4.1. Executed license agreement for the IP to support AA cell line commercialization.


 


Task
4.2. Negotiate distribution agreement with Indivumed to market and distribute Shuttle products.


Milestone
4.2. Executed distribution agreement for AA cell lines and ancillary products.


 


Task
4.3. Prepare the business plan and marketing materials for AA cell commercialization and distribution for use in a capital raise,
(engage consultant Glenn Peters - see letter of support)


Milestone
4.3. Commercialization and marketing plan for AA prostate cancer cells is available for implementation.


 


Past
Experience with similar studies: We have previously published on biological differences in the expression of genes affecting tumor
aggressiveness and metastases in cell lines established from AA as compared to CA patients (3). Our collaboration with Drs. Schlegel
and Liu resulted in a highly cited publication in American Journal of Pathology


 





	Attachment
    1: Statement of Work	Page
    3 of 4
	Dated:
    September 17, 2018 	 
	HHSN261201800016C	 


 




    	 



    	 



    

 


Chart
1: Gantt chart of project time line and work distribution between GU and SP.


 


Phase
II Milestones and Timeline


 


	 	 	 	 	Months

    1-6
	 	Months

    6-12
	 	Months

    12-18
	 	Months

    18-24

	Objective
    1	 	 	 	******	 	******	 	******	 	 
	GU/SP	 	Milestone
                                            1.1. 25 tumor and normal prostate epithelial cell cultures from prostatectomy specimens
                                            from AA patients.
	 	X	 	X	 	X	 	X
	GU/SP	 	Milestone
                                            1.2. 25 tumor and normal prostate epithelial cell cultures from prostate needle biopsy
                                            specimens from AA patients.
	 	X	 	X	 	X	 	X
	SP	 	Milestone
    1.3. Clinical and bioloaical annotations of AA cells are available, including differential gene expression by microarray
    analysis of 2D and 3D cultures.	 	X	 	X	 	X	 	X
	SP	 	Milestone
    1.4. 50 annotated cell cultures from AA patients (product #1).	 	 	 	X	 	X	 	X
	 	 	 	 	 	 	 	 	 	 	 
	Objective
    2	 	 	 	******	 	******	 	******	 	******
	SP/GU	 	Milestone
    2.1. At least three cateaories for grouping cells are identified for TMA manufacture in sets of 12 tumor cell lines and associated
    normal.	 	 	 	 	 	X	 	X
	SP/GU	 	Milestone
    2.2. Stock of reoresentative TMAs for each of the selected categories of AA cells (product #2).	 	 	 	 	 	X	 	X
	 	 	 	 	 	 	 	 	 	 	 
	Objective
    3	 	 	 	 	 	 	 	******	 	******
	SP	 	Milestone
    3.1. Stock of 100 ml vials of proprietary conditioned medium for AA cells.	 	X	 	X	 	X	 	X
	SP	 	Milestone
    3.2. Stock of AA cells capable of qrowth in proprietary conditioned medium.	 	 	 	X	 	X	 	X
	 	 	 	 	 	 	 	 	 	 	 
	Objective
    4	 	 	 	 	 	 	 	 	 	 
	SP	 	Milestone
                                            4.1. Executed license agreement for the IP to support AA cell line commercialization.
	 	X	 	 	 	 	 	 
	SP	 	Milestone
    4.2. Executed distribution agreement for AA cell lines and ancillary products.	 	 	 	 	 	X	 	X
	SP	 	Milestone
    4.3. Commercialization and marketing plan for AA prostate cancer cells is available for implementation.	 	 	 	X	 	X	 	X


 


SP
= Work will be performed in Shuttle Pharmaceuticals laboratory/offices


GU
= Work will be performed in Georgetown University Shared Resource facilities


 





	Attachment
    1: Statement of Work	Page
    4 of 4
	Dated:
    September 17, 2018 	 
	HHSN261201800016C	 


 




    	 



    	 



    

 


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


 


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


 


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


 


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


 


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


 


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


 


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




 


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




 


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


 


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




 




    	 



     


    

 


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 6 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.


 




    	 



     


    

 


Safety
and Health, HHSAR 352.223-70 (DEC 2015)


 


	a.	To help ensure the protection
  of the life and health of all persons, and to help prevent damage to property, the Contractor shall comply with all Federal, State,
  and local laws and regulations applicable to the work being performed under this contract. These laws are implemented or enforced by
  the Environmental Protection Agency, Occupational Safety and Health Administration (OSHA) and other regulatory/enforcement agencies
  at the Federal, State, and local levels.




 


	 	1.	In addition, the Contractor
  shall comply with the following regulations when developing and implementing health and safety operating procedures and practices for
  both personnel and facilities involving the use or handling of hazardous materials and the conduct of research, development, or test
  projects:




 


	 	I.	29 CFR 1910.1030, Bloodborne
  pathogens; 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories; and other applicable occupational health
  and safety standards issued by OSHA and included in 29 CFR part 1910. These regulations are available at https://www.osha.gov/.
	 	 	 
	 	II.	Nuclear Regulatory Commission
  Standards and Regulations, pursuant to the Energy Reorganization Act of 1974 (42 U.S.C. 5801 et seq.). The Contractor may obtain copies
  from the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.




 


	 	2.	The following Government
  guidelines are recommended for developing and implementing health and safety operating procedures and practices for both personnel
  and facilities:




 


	 	I.	Biosafety in Microbiological
  and Biomedical Laboratories, CDC. This publication is available at http://www.cdc.gov/biosafetv/publications/index.htm.
	 	 	 
	 	II.	Prudent Practices for Safety
  in Laboratories (1995), National Research Council, National Academy Press, 500 Fifth Street NW., Lockbox 285, Washington, DC 20055
  (ISBN 0-309-05229-7). This publication is available at http://www.nap.edu/catalog/4911/prudent-practices-in-the- laboratory-handling-and-disposal-of-chemicals.




 


	b.	Further, the Contractor shall
  take or cause to be taken additional safety measures as the Contracting Officer, in conjunction with the Contracting Officer’s
  Representative or other appropriate officials, determines to be reasonably necessary. If compliance with these additional safety measures
  results in an increase or decrease in the cost or time required for performance of any part of work under this contract, the Contracting
  Officer will make an equitable adjustment in accordance with the applicable “Changes” clause set forth in this contract.




 




    	1



     


    

 


	c.	The Contractor shall maintain
  an accurate record of, and promptly report to the Contracting Officer, all accidents or incidents resulting in the exposure of persons
  to toxic substances, hazardous materials or hazardous operations; the injury or death of any person; or damage to property incidental
  to work performed under the contract resulting from toxic or hazardous materials and resulting in any or all violations for which the
  Contractor has been cited by any Federal, State or local regulatory/enforcement agency. The report citing all accidents or incidents
  resulting in the exposure of persons to toxic substances, hazardous materials or hazardous operations; the injury or death of any person;
  or damage to property incidental to work performed under the contract resulting from toxic or hazardous materials and resulting in
  any or all violations for which the Contractor has been cited shall include a copy of the notice of violation and the findings of any
  inquiry or inspection, and an analysis addressing the impact these violations may have on the work remaining to be performed. The report
  shall also state the required action(s), if any, to be taken to correct any violation(s) noted by the Federal, State, or local regulatory/enforcement
  agency and the time frame allowed by the agency to accomplish the necessary corrective action.
	 	 
	d.	If the Contractor fails or
  refuses to comply with the Federal, State or local regulatory/enforcement agency’s directive(s) regarding any violation(s) and
  prescribed corrective action(s), the Contracting Officer may issue an order stopping all or part of the work until satisfactory corrective
  action (as approved by the Federal, State, or local regulatory/enforcement agencies) has been taken and documented to the Contracting
  Officer. No part of the time lost due to any such stop work order shall form the basis for a request for extension or costs or damages
  by the Contractor.
	 	 
	e.	The Contractor shall insert
  the substance of this clause in each subcontract involving toxic substances, hazardous materials, or hazardous operations. The Contractor
  is responsible for the compliance of its subcontractors with the provisions of this clause.




 


(End
of clause)


 




    	2



     


    

 





 



    	 



    	 



    




 


SBIR
Funding Agreement Certification


 


Grant
Contract Number: BAAN44CO89001 - 49


 


Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s)): Scott Grindrod, PhD


 


Public
reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection
of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-0001). Do not return the completed form to this address.


 


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 Notice of Award or Contract Award that is prior to performance of work under this award. This includes checking
all of the boxes and having an authorized officer of the awardee 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 Grants Management or 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 Grants Management or Contracting Officer believes, after award, that the business is not meeting
certain Notice of Award requirements, the agency may request further clarification and supporting documentation in order to assist in
the verification of any of the information provided.


 


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


 


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


 


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


 


☒
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 13 C.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:


 


	 	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:


 




    	OMB No. 0925-0001 (Rev. 06/15Approved Through 03/31/2020)	Page 1	SBIR Funding AgfHment Certification



    	 



    

 


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


 


	 	☒
    Yes ☐ No ☐ N/A 	Explain
    why N/A:


 


	 	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 Grants Management or Contracting Officer.


 


☒
Yes ☐ No Deviation approved in writing by Grants Management or 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 Grants Management or 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 Grants Management or 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 Grants Management or 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 Grants Management or 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 application and approved in the Notice of Award or Contract 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 an application 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


 




    	OMB No. 0925-0001 (Rev. 06/15Approved Through 03/31/2020)	Page 2	SBIR Funding AgfHment Certification



    	 



    

 


	 	15.	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 the business concern that the information provided in this certification, the application,
and all other information submitted in connection with this application, 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 9/12/2018
		
	 	 
	Signature	 
	 	 
	Printed Name (First, Middle, Last) Anatoly Dristchilo
	 	 	 
	Title CEO
	 	 
	Organization Name Shuttle Pharmaceuticals, Inc


 




    	OMB No. 0925-0001 (Rev. 06/15Approved Through 03/31/2020)	Page 3	SBIR Funding AgfHment Certification



    	 



    

 


HHS
Small Business Innovation Research Program


Life
Cycle Certification


 


Public
reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection
of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless
it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection
of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-0001). Do not return the completed form to this address.


 


All
SBIR Phase I and Phase II awardees 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 awardee sign and date the
certification each time it is required. Awardees are not required to submit this certification directly to NIH but must instead complete
the certification and maintain it on file in accordance with the records and retention policy in Section 8.4.2 of the NIH Grants Policy
Statement or as listed in the SBIR contract solicitation
or contract award.


 


A
certification is required at the following times:


 


	 	●	For
    SBIR Phase I Awardees : At the time of receiving final payment or disbursement from the Payment Management System or via contract.
	 	 	 
	 	●	For
    SBIR Phase II Awardees: prior to receiving more than 50% of the total award amount and prior to final payment or disbursement from
    the Payment Management System or via contract.


 


In
addition, SBIR awardees indicate compliance with these certification requirements by drawing or requesting funds from the Payment Management
System. If the grantee cannot complete this certification or cannot ensure compliance with the certification process, it should notify
the funding agreement officer immediately. If resolution cannot be reached, the funding agreement officer will void or terminate the
award, as appropriate.


 


Grant
or Contract Number:


 


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


 


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


 


If
the funding agreement 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):


 




    	OMB No. 0925-0002 (Rev. 06/15 Approved Through 03/31/2020)	Page 1	SBIR Life Cycle Certification



    	 



    

 


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


 


☐
Yes ☐ No Deviation approved in writing by funding agreement 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.


☐
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 funding agreement officer.


 


	 	3.	Upon
    completion of the award it will have performed the applicable percentage of work, unless a deviation from this requirement is approved
    in writing by the funding agreement 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 funding agreement 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 funding agreement 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 funding agreement 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 funding agreement
    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 application
    and approved in the Notice of Award or Contract Award.


 


☐
Yes ☐ No


 


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


 


☐
1 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 application,
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


 




    	OMB No. 0925-0002 (Rev. 06/15 Approved Through 03/31/2020)	Page 2	SBIR Life Cycle Certification