Document:

Exhibit
10.8

 

 

    	 

     

    

 

Contract
Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

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	9
	 	SECTION
    E - INSPECTION AND ACCEPTANCE	9
	 	SECTION
    F - DELIVERIES OR PERFORMANCE	9
	 	 	ARTICLE
    F.1. PERIOD OF PERFORMANCE	9
	 	 	ARTICLE
    F.2. DELIVERIES	10
	 	 	ARTICLE
    F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)	10
	 	SECTION
    G - CONTRACT ADMINISTRATION DATA	11
	 	 	ARTICLE
    G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR)	11
	 	 	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)	13
	 	 	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. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY	14
	 	 	ARTICLE
    H.3. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH	14
	 	 	ARTICLE
    H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING	14
	 	 	ARTICLE
    H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION	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 FROM USE OF LIVE VERTEBRATE ANIMALS	15
	 	 	ARTICLE
    H.9. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS	15
	 	 	ARTICLE
    H.10. GUN CONTROL	15
	 	 	ARTICLE
    H.11. LIMITATIONS ON SUBCONTRACTING - SBIR	16
	 	 	ARTICLE
    H.12. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-74 (December 2015)	16
	 	 	ARTICLE
    H.13. PUBLICATION AND PUBLICITY	16
	 	 	ARTICLE
    H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE	17
	PART
    II - CONTRACT CLAUSES	18
	 	SECTION
    I - CONTRACT CLAUSES	18
	PART
    III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS	22
	 	SECTION
    J - LIST OF ATTACHMENTS	22
	 	 	1.
    Statement of Work	22
	 	 	2.
    Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2	22
	 	 	3.
    Safety and Health	22
	 	 	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	23
	 	SECTION
    K - REPRESENTATIONS AND CERTIFICATIONS	23
	 	 	1.
    Annual Representations and Certifications	23
	 	 	2.
    Animal Welfare Assurance Number	23

 

    	-2-

     

    

 

Contract
Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

PART
I - THE SCHEDULE

 

SECTION
B - SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE
B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

In
this Phase I project the objectives are to develop and annotate AA prostate epithelial cancer cell line with donor matched normal prostate
epithelial cells and bio-banked reference prostate tissues. Also to support the feasibility of establishing 50 prostate cancer cell lines
from AA men in a subsequent Phase II application, prepare written protocols for tissue collection, processing, establishment of conditionally
reprogrammed cells and the reagents necessary for performing studies with these cells.

 

ARTICLE
B.2. PRICES

 

	 	a.	The
    total fixed price of this contract is $224,687.
	 	 	 
	 	b.	Upon
    delivery and acceptance of the item(s) and/or service(s) specified in the DELIVERY Article in SECTION F and described in SECTION
    C of this contract and identified in the schedule of charges below, the Government shall pay to the Contractor the unit prices set
    forth below:

 

PAYMENT
SCHEDULE

 

	Description	 	Invoice
    #	 	Period
    Covered	 	Amount	 
	PDF Kick-Off Presentation	 	HHSN261201600038C
    - 01	 	Month 1	 	$	50,000	 
	Quarterly Report 1	 	HHSN261201600038C - 02	 	Months 1-3	 	$	50,000	 
	Quarterly Report 2	 	HHSN261201600038C - 03	 	Months 4-6	 	$	50,000	 
	Draft Final Report	 	HHSN261201600038C - 04	 	Effective date of contract through one month
    prior to completion date of contract	 	$	37,344	 
	Final Report, Contract Outcomes Report, Final
    Presentaton, and all other contract deliverables	 	HHSN261201600038C - 05	 	Entire Period of Performance of contract	 	$	37,343	 
	TOTAL FIXED PRICE	 	 	 	 	 	$	224,687	 

 

ARTICLE
B.3. ADVANCE UNDERSTANDINGS

 

Other
provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.

 

	 	a.	Establishment
    of Indirect Cost Rate
	 	 	 
	 	 	Fringe
    Benefits costs are funded at a rate of 15% of Total Direct Labor Costs; Overhead costs are funded at a rate of 39% of Total Direct
    Labor and Fringe Benefits Costs; G&A is funded at a rate of 12% of Total Direct Labor and Fringe Benefits Costs; however, the
    Contractor shall not bill or be reimbursed for indirect costs until such time as an indirect cost proposal has been submitted to
    the cognizant office responsible for negotiating the indirect cost rates, unless a temporary billing rate(s) has been included herein.
    Unless otherwise specified below, the indirect cost rate proposal shall be submitted no later than three (3) months after the date
    of contract award.

 

    	-3-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	b.	Subcontract
	 	 	 
	 	 	To
    negotiate a fixed price type subcontract with Georgetown University for Cell and Animal-Based Models to Advance Health Disparity
    Research for an amount not to exceed $70,129 for the period 9/19/2016 through 6/18/2017. Award of the subcontract shall not proceed
    without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2,
    Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract
    shall be provided to the Contracting Officer.
	 	 	 
	 	c.	Contract
    Number Designation
	 	 	 
	 	 	On
    all correspondence submitted under this contract, the Contractor agrees to clearly identify the two contract numbers that appear
    on the face page of the contract as follows:

 

Contract
No. HHSN261201600038C.

 

NCI
Control No. N43CO-2016-00038 .

 

	 	d.	SBIR
    Funding Agreement Certification
	 	 	 
	 	 	The
    SBIR Funding Agreement Certification form, located in SECTION J, must be completed at the time of award prior to the performance
    of work under this contract, in accordance with the SBIR Policy Directive issued by SBA (October 18, 2012).
	 	 	 
	 	 	For
    additional information, see NIH Policy Notice NOT-OD-13-116, entitled, “New Program Certifications Required for SBIR and STTR
    Awards,” located at: http://grants.nih.gov/qrants/guide/notice-files/NQT-OD-13-116.html.

 

SECTION
C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

ARTICLE
C.1. STATEMENT OF WORK

 

	 	a.	Independently
    and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment,
    and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, dated September 19, 2016, 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.”

 

    	-4-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	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;
	 	 	 	 	 
	 	 	 	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.

 

    	-5-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038
 

	 	3.	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
4).

 

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.

 

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: Draft Commercialization Plan

 

	 	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.
	 	 	 
	 	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.

 

    	-6-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

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

 

	 	●	Letter
    of commitment of funding.
	 	 	 
	 	●	Letter
    of intent or evidence of negotiations to provide funding, should the Phase II project be successful and the market need still exist.
	 	 	 
	 	●	Letter
    of support for the project and/or some in-kind commitment, e.g., to test or evaluate the innovation.
	 	 	 
	 	●	Specific
    steps the Contractor is going to take to secure Phase III funding.

 

	 	f.	Production
    and Marketing Plan
	 	 	 
	 	 	Describe
    how the production of the Contractor’s product/process/service will occur ( e.g., in-house manufacturing, contract manufacturing).
    Describe the steps the Contractor will take to market and sell the Contractor’s product/process/service. For example, explain
    plans for licensing, Internet sales, etc.
	 	 	 
	 	g.	Revenue
    Stream
	 	 	 
	 	 	Explain
    how the Contractor plans to generate a revenue stream for the Contractor’s organization should this project be a success. Examples
    of revenue stream generation include, but are not limited to; manufacture and direct sales, sales through value added resellers or
    other distributors, joint venture, licensing, service. Describe how the Contractor’s staffing will change to meet the Contractor’s
    revenue expectations.

 

	 	4.	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 3).
	 	 	 
	 	5.	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.
	 	 	 
	 	6.	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;

 

    	-7-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	 	d.	Discussion
    of proposed milestones and whether they were achieved during the contract performance;
	 	 	 	 
	 	 	e.	Summary
    of submitted commercialization plan;
	 	 	 	 
	 	 	f.	Discussion
    of the anticipated Phase II activities with emphasis on how they fit into the commercialization plan, if Contractor is interested
    in pursuing Phase II research;
	 	 	 	 
	 	 	g.	Questions
    to the NCI.

 

	 	b.	Other
    Reports/Deliverables
	 	 	 	 
	 	 	1.	Section
    508 Annual Report
	 	 	 	 
	 	 	 	The
    contractor shall submit an annual Section 508 report in accordance with the schedule set forth in the ELECTRONIC AND INFORMATION
    TECHNOLOGY ACCESSIBILITY Article in SECTION H of this contract. The Section 508 Report Template and Instructions for completing the
    report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under “Vendor Information and
    Documents.”
	 	 	 	 
	 	 	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://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-116.html.

 

ARTICLE
C.3. INVENTION REPORTING REQUIREMENT

 

All
reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to,
the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division
of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland
20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement,
shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(H)) shall be submitted to the Contracting
Officer on or before the completion date of the contract.

 

If
no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative
report shall be submitted to the Contracting Officer via e-mail.

 

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.

 

    	-8-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

SECTION
D - PACKAGING, MARKING AND SHIPPING

 

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

 

SECTION
E - INSPECTION AND ACCEPTANCE

 

	 	a.	The
    Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be
    provided.
	 	 	 
	 	b.	For
    the purpose of this SECTION, the Contracting Officer’s Representative (COR) is the authorized representative of the Contracting
    Officer.
	 	 	 
	 	c.	Inspection
    and acceptance will be performed at:
	 	 	 
	 	 	National
                                            Cancer Institute

    9609
    Medical Center Drive

    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 clause by reference, with the same force and effect as if it were given in full text. Upon request,
    the Contracting Officer will make its full text available.
	 	 	 
	 	 	FAR
    Clause 52.246-9, Inspection of Research and Development (Short Form) (April 1984).
	 	 	 
	 	 	FAR
    Clause 52.246-16, Responsibility for Supplies (April 1984).

 

SECTION
F - DELIVERIES OR PERFORMANCE

 

ARTICLE
F.1. PERIOD OF PERFORMANCE

 

The
period of performance of this contract shall be from 09/19/2016 through 06/18/2017.

 

    	-9-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

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 the contract.
	(3)	 	Quarterly
    Report One	 	Due
    on or before 15 calendar days following completion of 3 full months of contract performance.
	(4)	 	Quarterly
    Report Two	 	Due
    on or before 15 calendar days following completion of 6 full months of contract performance.
	(5)	 	Draft
    Final Report	 	Due
    on or before 1 month prior to the contract completion date.
	(6)	 	Final
    Report	 	Due
    on or before the contract completion date.
	(7)	 	Contract
    Outcomes Report	 	Due
    on or before the contract completion date.
	(8)	 	Final
    Presentation	 	Due
    on or before the contract completion date.
	(9)	 	Final
    Invention Statement	 	Due
    on or before the contract completion date.
	(W)	 	Invention
    Disclosure Report	 	Due
    on or before the contract completion date.
	(11)	 	SBIR
    Program Life Cycle Certification	 	Due
    on or before the contract completion date.
	(12)	 	Section
    508 Annual Report	 	Due
    on or before the contract completion date.

 

	 	b.	The
    above items shall be addressed and delivered to ncibrancheinvoices@mail.nih.gov. as well as to the following addressees:

 

	Addressee	 	Deliverables
	Kathleen
                                            Sears

    Office
    of Acquisitions

    searskv@mail.nih.aov
	 	All
    deliverables, in electronic format.
	 	 	 
	Todd
                                            Haim

    NCI
    SBIR & STTR Programs

    Haimte@mail.nih.aov
	 	All
    deliverables, in electronic format.
	 	 	 
	OPERA,
                                            OEH, NIH

    6705
    Rockledge Drive

    Suite
    310, MSC 7980

    Bethesda,
    MD 20892-7980
	 	Items
    9 and 10, in hard copy.

 

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

 

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

 

FEDERAL
ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

 

52.242-15,
Stop Work Order (August 1989)

 

Alternate
I (April 1984) is not applicable to this contract.

 

    	-10-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

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:

 

Todd
Haim

 

The
COR is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance
and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance
requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this
contract; and (5) assisting in the resolution of technical problems encountered during performance.

 

The
Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer
has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change
the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract;
(5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall
be incorporated by reference in Section K of the contract

 

The
Government may unilaterally change its COR designation.

 

ARTICLE
G.2. KEY PERSONNEL, HHSAR 352.237-75 (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
	Dr.
    Johng Rhim	 	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.

 

    	-11-

     

    

     

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	 	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: YourVendorNameJnvoice
    number (e.g., if you are submitting Invoice 123456, save the single attachment as “Ash Stevensjnvoice 123456”) [Note:
    Please do not use special characters such as (#, $, %,*, &, I) when saving your attachment. Only the underscore symbol (_) is
    permitted.]
	 	 	 	 
	 	 	3.	Transmit
    the saved single attachment via e-mail to the appropriate branch’s Central Point of Distribution. For the purpose of this
    contract, the Central Point of Distribution is NCI OA Branch 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
	 	 	 	 
	 	 	 	(e.g,
    HHSN2612XXXXXC_Clinical Genetics SupportAsh Stevens J nvoice 12345) [Note: The original payment request must still be submitted
    in hard copy and mailed to the designated billing office listed in subparagraph a, above, to meet the requirements of a “proper
    invoice.” Also, The Contractor must certify on the payment request that the electronic courtesy copy is a duplicate of the
    original invoice mailed to NIH’s Office of Financial Management.]

 

	 	2.	In
    addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information
    on the face page of all payment requests:
	 	 	 	 
	 	 	a.	Name
    of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute .
	 	 	 	 
	 	 	b.	Federal
    Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number
    (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name on the face page of the contract.
    If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
	 	 	 	 
	 	 	c.	DUNS
    or DUNS+4 Number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract and as
    registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify
    the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor’s name
    on the face page of the contract. 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.

 

    	-12-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	 	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 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)

 

ARTICLE
G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

	 	a.	Contractor
    Performance Evaluations
	 	 	 
	 	 	A
    Final evaluation 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.
	 	 	 
	 	 	The
    Final evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will
    be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot
    be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision
    will be final.
	 	 	 
	 	 	Copies
    of the evaluation, 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.

 

    	-13-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

ARTICLE
H.2. 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, NOT-OD-15-1Q3,
“Enhancing Reproducibility through Rigor and Transparency” and NOT-OD-15-102. “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-training/rigor-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.

 

ARTICLE
H.3. 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/guide/notice-files/NOT-QD-09-Q71.html and http:// publicaccess.nih.gov.

 

ARTICLE
H.4. ACKNOWLEDGEMENT OF FEDERAL FUNDING

 

The
Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents
describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or
project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage
and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

 

ARTICLE
H.5. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

 

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

 

ARTICLE
H.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.

 

    	-14-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	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.gov: Web site: (http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

 

(End
of clause)

 

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://grants1.nih.gov/grants/olaw/references/phspol.htm

 

In
addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate
Animal Section (VAS) of the contractor’s technical proposal, as modified in the Final Proposal Revision (FPR), dated 9/19/2016,
which is incorporated by reference.

 

ARTICLE
H.8. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS

 

UNDER
GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE (PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE
ANIMALS WITHOUT PRIOR APPROVAL BY THE OFFICE OF LABORATORY ANIMAL WELFARE (OLAW), OF [AN ANIMAL WELFARE ASSURANCE THAT COMPLIES WITH
THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS AND/OR A VALID INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) APPROVAL],
THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES (e.g. COLLABORATING INSTITUTIONS, SUBCONTRACTORS, SUBGRANTEES) WITHOUT OLAW-APPROVED
ASSURANCES, WHETHER DOMESTIC OR FOREIGN.

 

ARTICLE
H.9. 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.10. GUN CONTROL

 

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

 

    	-15-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

ARTICLE
H.11. LIMITATIONS ON SUBCONTRACTING - SBIR

 

The
Contractor shall perform a minimum of two-thirds 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.12. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-74 (December 2015)

 

	 	a.	Pursuant
    to Section 508 of the Rehabilitation Act of 1973(29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic
    and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply
    with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility
    Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access
    Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of
    Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.
	 	 	 
	 	b.	The
    Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification
    or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s)
    at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration
    is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform
    to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified
    in the contract will be the responsibility of the Contractor at its own expense.
	 	 	 
	 	c.	The
    Section 508 accessibility standards applicable to this contract are: None.
	 	 	 
	 	d.	In
    the event of a modification(s) to this contract or order,which adds new EIT supplies or services or revises the type of, or specifications
    for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment
    Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services
    conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment
    Template may be found under Section 508 policy on the HHS Web site: (http://www.hhs.gov/web/508). If it is determined by the Government
    that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract,
    remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor
    at its own expense.
	 	 	 
	 	e.	If
    this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests
    that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the
    Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information
    necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards.
    Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508.
    If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility
    standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract
    will be the responsibility of the Contractor at its own expense.

 

(End
of clause)

 

ARTICLE
H.13. 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. HHSN261201600038C.”

 

    	-16-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

ARTICLE
H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

 

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

 

	 	US
    Department of Health and Human Services
	 	Office
    of Inspector General
	 	ATTN:
    OIG HOTLINE OPERATIONS
	 	P.O.
    Box 23489
	 	Washington,
    D.C. 20026

 

ARTICLE
H.15. 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
(CO). The Contractor shall submit an advance copy of the press release to the Contracting Officer and Contracting Officer’s Representative
(COR). Upon acknowledgement 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.

 

    	-17-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

PART
II - CONTRACT CLAUSES

 

SECTION
I - CONTRACT CLAUSES

 

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

 

This
contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request,
the Contracting Officer will make their full text available. Also, the full text o f a clause may be accessed electronically as follows:
FAR Clauses at: http://www.acquisition.gov/far/. HHSAR Clauses at: http://www.hhs.gov/Dolicies/hhsar/subDart352.html.

 

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

 

	FAR
    

    CLAUSE NO.	 	DATE	 	TITLE
	52.202-1	 	Nov
    2013	 	Definitions
    (Over the Simplified Acquisition Threshold)
	52.203-12	 	Oct
    2010	 	Limitation
    on Payments to Influence Certain Federal Transactions (Over $150,000)
	52.203-17	 	Apr
    2014	 	Contractor
    Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (Over the Simplified Acquisition Threshold)
	52.203-99	 	Feb
    2015	 	Prohibition
    on Contracting with Entities That Require Certain Internal Confidentiality Agreements (DEVIATION)
	52.204-10	 	Oct
    2015	 	Reporting
    Executive Compensation and First-Tier Subcontract Awards ($30,000 or more)
	52.204-13	 	Jul
    2013	 	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)
	52.215-8	 	Oct
    1997	 	Order
    of Precedence - Uniform Contract Format
	52.219-6	 	Jul
    1996	 	Notice
    of Total Small Business Set-Aside
	52.222-3	 	Jun
    2003	 	Convict
    Labor
	52.222-21	 	Apr
    2015	 	Prohibition
    of Segregated Facilities
	52.222-26	 	Apr
    2015	 	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)
	52.222-50	 	Mar
    2015	 	Combating
    Trafficking in Persons
	52.222-54	 	Oct
    2015	 	Employment
    Eligibility Verification (Over the Simplified Acquisition Threshold)
	52.223-6	 	May
    2001	 	Drug-Free
    Workplace
	52.223-18	 	Aug
    2011	 	Encouraging
    Contractor Policies to Ban Text Messaging While Driving
	52.225-1	 	May
    2014	 	Buy
    American - Supplies
	52.225-13	 	Jun
    2008	 	Restrictions
    on Certain Foreign Purchases
	52.227-1	 	Dec
    2007	 	Authorization
    and Consent, Alternate 1 (Apr 1984)
	52.227-2	 	Dec
    2007	 	Notice
    and Assistance Regarding Patent and Copyright Infringement

 

    	-18-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	FAR

    CLAUSE NO.	 	DATE	 	TITLE
	52.227-11	 	May
    2014	 	Patent
    Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements
    in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
	52.227-20	 	May
    2014	 	Rights
    in Data - SBIR Program
	52.232-9	 	Apr
    1984	 	Limitation
    on Withholding of Payments
	52.232-23	 	May
    2014	 	Assignment
    of Claims
	52.232-25	 	Jul
    2013	 	Prompt
    Payment
	52.232-33	 	Jul
    2013	 	Payment
    by Electronic Funds Transfer-System for Award Management
	52.232-39	 	Jun
    2013	 	Unenforceability
    of Unauthorized Obligations
	52.233-1	 	May
    2014	 	Disputes
	52.233-3	 	Aug
    1996	 	Protest
    After Award
	52.233-4	 	Oct
    2004	 	Applicable
    Law for Breach of Contract Claim
	52.243-1	 	Aug
    1987	 	Changes
    - Fixed Price, Alternate V (Apr 1984)
	52.244-6	 	Jun
    2016	 	Subcontracts
    for Commercial Items
	52.249-1	 	Apr
    1984	 	Termination
    for the Convenience of the Government (Fixed-Price) (Short Form)
	52.249-9	 	Apr
    1984	 	Default
    (Fixed-Price Research and Development)(Over the Simplified Acquisition Threshold)
	52.253-1	 	Jan
    1991	 	Computer
    Generated Forms

 

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

 

	HHSAR
    

    CLAUSE NO.	 	DATE	 	TITLE
	352.203-70	 	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 I CONTRACT- Rev. 08/2016],

 

ARTICLE
I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

 

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

 

	 	a.	Alternate
    IV (October 2010) of FAR Clause 52.215-21, Requirements for Certified Cost or Pricing Data and Data Other Than Certified
    Cost or Pricing Data-Modifications (October 2010) is added.
	 	 	 
	 	b.	The
    following clause(s) are added to this contract:
	 	 	 	 

	 	 	●	FAR
    Clause 52.203-3, Gratuities (April 1984)
	 	 	 	 
	 	 	●	FAR
    Clause 52.203-5, Covenant Against Contingent Fees (May 2014)

 

    	-19-

     

    

 

	 	 	●	FAR
    Clause 52.203-6, Restrictions on Subcontractor Sales to the Government (September 2006)
	 	 	 	 
	 	 	●	FAR
    Clause 52.203-7, Anti-Kickback Procedures (May 2014)
	 	 	 	 
	 	 	●	FAR
    Clause 52.203-8, Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (May 2014)
	 	 	 	 
	 	 	●	FAR
    Clause 52.203-10, Price or Fee Adjustment for Illegal or Improper Activity (May 2014)
	 	 	 	 
	 	 	●	FAR
    Clause 52.204-4, Printed or copied Double-Sided on Postconsumer Fiber Content Paper (May 2011)
	 	 	 	 
	 	 	●	FAR
    Clause 52.215-2, Audit and Records Negotiation (October 2010)
	 	 	 	 
	 	 	●	FAR
    Clause 52.215-14, Integrity of Unit Prices (October 2010)
	 	 	 	 
	 	 	●	FAR
    Clause 52.219-8, Utilization of Small Business Concerns (October 2014)
	 	 	 	 
	 	 	●	FAR
    Clause 52.219-14, Limitations on Subcontracting (December 1996)
	 	 	 	 
	 	 	●	 FAR
    Clause 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (December 2010)
	 	 	 	 
	 	 	●	FAR
    Clause 52.229-3, Federal, State and Local Taxes (February 2013)
	 	 	 	 
	 	 	●	FAR
    Clause 52.232-2, Payments under Fixed-Price Research and Development Contracts (April 1984)
	 	 	 	 
	 	 	●	FAR
    Clause 52.232-17, Interest (May 2014)
	 	 	 	 
	 	 	●	FAR
    Clause 52.242-13, Bankruptcy (July 1995)
	 	 	 	 
	 	 	●	FAR
    Clause 52.244-5, Competition in Subcontracting (December 2010)

 

	 	The
    following clause(s) is substituted as follows:
	 	 	 	 
	 	 	●	FAR
    Clause 52.249-1, Termination for the Convenience of the Government (Fixed-Price)(Short Form) (April 1984) is deleted in its
    entirety and FAR Clause 52.249-2, Termination for the Convenience of the Government (Fixed Price) (April 2012) is substituted
    therefor.

 

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)

 

    	-20-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

	 	 	2.	HHSAR
    Clause 352.223-70, Safety and Health (December 2015)
	 	 	 	 
	 	 	3.	HHSAR
    Clause 352.231-70, Salary Rate Limitation (December 2015)

 

	 	Note:
    The Salary Rate Limitation is at the Executive Level II Rate.
	 	 
	 	See
    the following website for Executive Schedule rates of pay: https://www.opm.gov/policy-data-oversight/pav-leave/salaries-wages/.
	 	 
	 	(For current year rates, click on Salaries and Wages/Executive Schedule/Rates of Pay for the Executive Schedule. For prior year rates,
    click on Salaries and Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay for the Executive Schedule.
    Rates are effective January 1 of each calendar year unless otherwise noted.)

 

ARTICLE
1.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

 

This
contract incorporates the following clauses in full text.

 

	 	a.
    	THERE
    ARE NO APPLICABLE CLAUSES IN THIS SECTION.

 

    	-21-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

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 19, 2016, 2 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.

 

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.gov/grants/funding/sbir_forms/SBIR%20Fundina%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.

 

    	-22-

     

    

 

Contract
                                            Number: HHSN261201600038C

NCI
Control Number: N43CO-2016-00038

 

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.
    	Animal
    Welfare Assurance Number A3282-1.

 

END
of the SCHEDULE

 

(CONTRACT)

 

    	-23-

     

    

 

Statement
of Work (Phase I) Dated 09/19/2016

Contract
No. HHSN261201600038C

 

STATEMENT
OF WORK (Phase I)

 

	TITLE:	Cell-Based
    Models for Prostate Cancer Health Disparity Research
	 	 
	PRINCIPAL
    INVESTIGATOR: 	Dr.
    Johng Rhim
	 	 
	PROJECT
    DURATION:	9
    months
	 	 
	COMPANY:	Shuttle
    Pharmaceuticals, LLC
	 	 
	SUBCONTRACTORS:	Georgetown
    University

 

I.
Background Information and Objectives

 

A.
Background Information

 

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. The causes of disparities have been attributed
to socioeconomic differences, environmental exposures and biological factors. Most disparities studies have been population based, in
part, due to the lack of relevant in vitro and in vivo models to support biological studies. In this Phase I proposal, we will develop
an annotated AA prostate epithelial cancer cell line with donor matched normal prostate epithelial cells and bio-banked reference prostate
tissues. To support the feasibility of establishing 50 prostate cancer cell lines from AA men in a subsequent Phase II application, we
will prepare written protocols for tissue collection, processing, establishment of conditionally reprogrammed cells and the reagents
necessary for performing studies with these cells. We will determine commercial feasibility for cell distribution and reagent marketing
through a private-public partnership.

 

B.
Technical Objectives

 

The
three technical objectives of this proposal focus on determining the feasibility for establishing paired cancer and normal epithelial
cell lines from African-American patients presenting with prostate cancers. In the first objective, three previously harvested, de-identified
and bio-banked prostate cells from AA patients will be grown and characterized to develop standard operating protocols and optimal media
conditions. The second objective will be to optimize growth medium for use with AA cell lines. The third objective is to negotiate intellectual
property (license) through Georgetown University to support commercialization of AA cell lines.

 

Objective
1. Grow paired cancer and normal epithelial cells from AA prostate tumors and normal biopsy specimens bio-banked on IRB protocol # 2012-163.

 

Task
1.1. Establish malignant and non-malignant cell lines from AA prostatectomy specimens.

 

Milestone
1.1. Expand and freeze 20 vials for each AA cell line to perform characterizations.

 

Task
1,2. Characterize and annotate AA cells.

 

Milestone
1.2, Full characterization of AA cell lines, including: cell origin, cell growth > 30 passages, capacity to form xenograft tumors,
karyotypes, expression of prostate tissue and tumor specific markers, STR authentication and Mycoplasma testing

 

Task
1,3. Expand early passages of CRCs for freezing and banking in the CRC bio-repository.

 

Milestone
1.3. 50 vials of 1-2x10A6 cells/vial are banked for each normal/tumor AA cell pair.

 

Task
1,4. Prepare written protocols and standard operating procedures (SOPs) for establishing AA cell lines.

 

Milestone
1.4, SOPs for establishing AA cell lines and SOPs for cell growth and annotation.

 

Objective
2. Determine the optimal growth medium and conditions for growing prostate CRCs with and without irradiated feeder cells.

 

Task
2.1. Collect and concentrate the conditioned medium from J2-irradiated fibroblasts in sufficient quantity to support AA cell growth
in 50 flasks. Test effects of graded concentrations of conditioned medium on AA cells using telomerase and cell growth assays.

 

Milestone
2.1,1. Documentation of effects of conditioned medium on AA cell growth.

 

Milestone
2.1.2. Optimal formulation of conditioned medium supplement for AA prostate cell growth.

 

Task
2.2. Optimize the panel of supplementary growth factors for AA prostate CRC cell growth.

 

Milestone
2.2. Proprietary formula of growth factors needed to promote AA CRC culture growth.

 

    	 	Page 1	ATTACHMENT 1

     

    

 

Statement
of Work (Phase I) Dated 09/19/2016

Contract
No. HHSN261201600038C

 

Task
2.3. Compare cell characteristics under different media and growth conditions.

 

Milestone
2.3. Determine cell growth over at least 30 passages, capacity to form xenograft tumors, karyotype at early and late passages and
expression of prostate specific markers.

 

Objective
3. Negotiate a licensing agreement for commercialization of AA derived cells, submit a Phase I final report to SBIR administration and
prepare a Phase II SBIR application.

 

Task
3.1. Through the GU Office of Technology Commercialization, negotiate to obtain a licensing agreement to support commercialization
of established AA cells.

 

Milestone
3.1. Executed licensing agreement.

 

Task
3.2. Submit a written final Phase I report to SBIR administration.

 

Milestone
3.2. Phase I milestones have been reached and SBIR administration is informed of the technical and commercial feasibility of establishing
50 model AA cell lines supporting a Phase II application in response to an appropriate NIH/SBIR RFA.

 

II.
Services to be Performed

 

A.
General Requirements

 

	 	1.	The
    contractor shall independently perform all work and furnish all labor, materials, supplies, equipment, and services (except as otherwise
    specified in the contract).
	 	 	 
	 	2.	All
    work will be monitored by the Government Project Officer identified in Section G of the contract.

 

B.
Specific Requirements

 

Phase
I Milestones and Timeline

 

	Objectives	 	Milestone	 	Months

    1-3
	 	Months

    

    4-6
	 	Months

    

    7-9

	Objective
    1	 	 	 	***	 	***	 	 ***
	 	 	Milestone
    1.1.Repository of 20 frozen vials of each initial model AA cell line.	 	X	 	 	 	 
	 	 	Milestone
    1.2. Annotation data completed for initial AA cell lines	 	 	 	X	 	 
	 	 	Milestone
    1.3. Repository of 50 frozen vials of each AA cell line.	 	 	 	 	 	X
	 	 	Milestone
    1.4. Written protocols, annotation reports and SOP’s.	 	 	 	X	 	X
	Objective
    2	 	 	 	 	 	***	 	***
	 	 	Milestone
    2.1. Optimal media formula for growing AA prostate cells.	 	 	 	X	 	 
	 	 	Milestone
    2.2. Growth media supplements for AA prostate cells.	 	 	 	X	 	 
	 	 	Milestone
    2.3. Annotation of cell growth, xenograft tumor formation, genetic analysis, marker expression, and cell of origin	 	 	 	 	 	X
	Objective
    3	 	 	 	 	 	 	 	***
	 	 	Milestone
    3.1. Executed licensing agreement.	 	 	 	 	 	X
	 	 	Milestone
3.2. Written final report of achieved Phase 1 milestones and application for Phase II SBIR funding
	 	 	 	 	 	X

 

    	 	Page 2	ATTACHMENT 1

     

    

 

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.

 

    	NIH(RC)-2
 Revised 7/2013	1	ATTACHMENT 2

     

    

 

	 	If
    all or part of an invoice is suspended and the contractor chooses to reclaim those costs on a supplemental invoice, the contractor
    may use the same unique invoice number followed by an alpha character, such as “R” for revised (example: 8675309-05R).
	 	 
	(d)	Date
    Invoice/Voucher Prepared: Insert the date the payment request is prepared.
	 	 
	(e)	Contract
    Number and Order Number (if applicable): Insert the contract number and order number (as applicable).
	 	 
	(f)	Contract
    Title: Insert the contract title listed on the cover page of the contract and/or Section G of the Contract Schedule.
	 	 
	(g)	Current
    Contract Period of Performance: Insert the contract start date/effective date through the current completion date of the contract.
	 	 
	(h)	Total
    Fixed-Price of Contract/Order: Insert the total fixed-price of the contract/order.
	 	 
	(i)	Two-Way/Three-Way
    Match: Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer
    to the Invoice Submission Instructions in Section G of the Contract Schedule.
	 	 
	(j)
    	Office
    of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section
    G of the Contract Schedule.
	 	 
	(k)	Central
    Point of Distribution: Identify the Central Point of Distribution, as specified in the Invoice Submission Instructions in Section
    G of the Contract Schedule.
	 	 
	(l)	Billing
    Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which
    reimbursement is claimed.
	 	 
	(m)	Description
    of Supplies or Services: Provide a description of the supplies or services, by line item (if applicable), quantity, unit price
    (where appropriate), and total amount. The item description, unit of measure, and unit price must match those specified in
    the contract. For example, if the contract specifies 1 box of hypodermic needles (100/box) with a unit price of $50.00, then the
    invoice must state 1 box, hypodermic needles (100/box), $50.00, not 100 syringes at $0.50 each. Invoices that do not match
    the line item pricing in the contract will be considered improper and will be returned to the Contractor.
	 	 
	(n)	Amount
    Billed - Current Period: Insert the amount claimed for the current billing period, including any adjustments, if applicable.
    If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request.
	 	 
	(o)	Amount
    Billed - Cumulative: Insert the cumulative amounts claimed to date, including any adjustments as applicable. If the Contract
    Schedule contains separately priced line items, identify the contract line item(s) on the payment request.

 

	(p)	Freight
    or Delivery Charges: Identify all charges for freight or express shipments, other than f.o.b. destination, as a separate line
    item on the invoice. (If shipped by freight or express, and charges are more than $25, attach prepaid bill.)
	 	 
	(q)	Government
    Property: If the contract authorizes the purchase of any item of Government Property (e.g., equipment), the invoice must list
    each item for which reimbursement is requested. Include reference to the following (as applicable):
	 	 
	 	-	item
    number for the specific piece of equipment listed in the Property Schedule, and
	 	 	 
	 	-	Contracting
    Officer Authorization (COA) Number, if the equipment is not covered by the Property Schedule.

 

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

     

    

 

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/biosafety/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.

 

    	ATTACHMENT 3

     

    

 

	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)

 

    	ATTACHMENT 3

     

    

 

 

    	 

     

    

 

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

 

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

 

	 	1.	Identify
    the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal
    action.
	 	 	 
	 	2.	Identify
    the status of the covered Federal action.
	 	 	 
	 	3.	Identify
    the appropriate classification of this report. If this is a followup report caused by a material change to the information previously
    reported, enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this
    reporting entity for this covered Federal action.
	 	 	 
	 	4.	Enter
    the full name, address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriateclassification
    of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee,
    e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract
    awards under grants.
	 	 	 
	 	5.	If
    the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address, city, State and
    zip code of the prime Federal recipient. Include Congressional District, if known.
	 	 	 
	 	6.	Enter
    the name of the Federal agency making the award or loan commitment. Include at least one organizationallevel below agency name, if
    known. For example, Department of Transportation, United States Coast Guard.
	 	 	 
	 	7.	Enter
    the Federal program name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic
    Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.
	 	 	 
	 	8.	Enter
    the most appropriate Federal identifying number availablefor the Federal action identified in item 1 (e.g., Request for Proposal
    (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal
    control number assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.”
	 	 	 
	 	9.	For
    a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the
    award/loan commitment for the prime entity identified in item 4 or 5.
	 	 	 
	 	10.	(a)
    Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged
    by the reporting entity identified in item 4 to influence the covered Federal action.
	 	 	 
	 	 	(b)
    Enter the full names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name,
    First Name, and Middle Initial (Ml).
	 	 	 
	 	11.	The
    certifying official shall sign and date the form, print his/her name, title, and telephone number.

 

 

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

 

 

    		2	Attachment 4

     

    

 

SBIR
Funding Agreement Certification

 

Grant
Contract Number:

 

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

 

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:

 

    		1	Attachment 5

     

    

 

	 	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:

 

    		2	SBIR Funding Agreement
Attachment
                                            5
Certification                       

     

    

 

	 	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	
	 	 	 	 	 
	 	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
	 
	Signature
	 
	Printed
    Name (First, Middle, Last)
	 
	Title
	 
	Organization
    Name

 

    		3	SBIR Funding Agreement
Attachment 5
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.

 

    		1	SBIR Life Cycle Certification
Attachment 6

     

    

 

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

 

	1.	The
    principal investigator spent more than one half of his/her time as an employee of the 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

 

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

 

☐
I understand that the information submitted may be given to Federal, State and local agencies for

 

determining
violations of law and other purposes.

 

☐
I am an officer of the business concern authorized to represent it and sign this certification on its behalf.
By signing this certification, I am representing on my own behalf, and on behalf of the business concern that the information provided
in this certification, the 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

 

    		2	SBIR Life Cycle Certification
Attachment
                                            6Exhibit 10.9

 

Shuttle
Pharmaceuticals, Inc.

1
Research Ct. Suite 450 ● Rockville, MD 20850 ● TEL (240) 403-4212 ● FAX (301) 519-8001

 

 

MATERIALS
TRANSFER AGREEMENT

 

This
Material Transfer Agreement (“Agreement”) is hereby made by and between the GeorgeWashington University (hereinafter
“Recipient”) and Shuttle Pharmaceuticals, Inc, Rockville, MD (hereinafter “Provider”) upon request from
Recipient for the following material (hereinafter “Material”) more particularly described below:

 

[DESCRIPTION
OF MATERIAL]

 

Recipient
and Provider hereby agree to conform to the following terms related to transfer of Material: Small molecule ATM activator/HDAC inhibitor
and selective HDAC inhibitor

 

1.
The above-described Material is the property of the Provider and is made available as a service to the research
community.

 

 2. The Material is not intended for and will not be used in human subjects.

 

 3. The Material will be used for teaching or not-for-profit research purposes only.

 

4.
The Material will not be distributed further to others without the Provider’s prior express written consent. The Recipient
shall refer any third-party request for the Material to the Provider.

 

5. The Recipient agrees to acknowledge the source of the Material in any publication reporting its use.

 

6.
Any Material delivered pursuant to this Agreement is understood to be experimental in nature and may contain hazardous properties.
The Provider makes no representations and extends no warranties of any kind, either express or implied. Unless prohibited by law,
Recipient assumes all liability for claims of damages against Recipient by third-parties which may arise from the use, storage, or
disposal of the Material except that, to the extent permitted by law, the Provider shall be liable to the Recipient when the damage
is caused by the gross negligence or willful misconduct of the Provider.

 

7.
The Recipient agrees to use the Material in compliance with all applicable state and federal statutes and regulations.

 

8.
The Material is provided at no cost or with an optional transmittal fee solely to reimburse the Provider for its preparation and
distribution costs. If a fee is requested, the amount is indicated here: $        waived       .

 

Shuttle
Pharmaceuticals, LLC ● 1 Research Court, Suite 450 ● Rockville, MD 20850

 

    	 

     

    

 

PROVIDER
INFORMATION AND AUTHORIZED SIGNATURE:

 

	Date:	 	 	 
	 	 	 	Anatoly
                                    Dritschilo, MD

                                    CEO

                                    Shuttle
                                    Pharmaceuticals, Inc

                                    One
                                    Research Court, Suite 450

                                    240-403-4212

                                    anatoly.dritschilo@shuttlepharma.org

	 	 	 
	 	 	Provider

 

RECIPIENT
INFORMATION AND AUTHORIZED SIGNATURE:

 

	Date: 	4-24-2017	 	
	 	 	Charles
                                            T. Maples

    Sr.
    Contracting Officer, Sponsored Projects

    Office of the Vice President for Research

    George Washington University

    2121
    Eye Street, NW, Suite 601

    Washington, DC 20052 USA

     

    Recipient

 

	READ AND ACKNOWLEDGED

                                                                                 

                                                                                          4/24/2017
	 	 
		 	

    Alejandro
    Villagra, PhD

    Assistant Professor

    Cancer
    Biology Program, GW Cancer Center

     

    Department
    of Biochemistry and Molecular Medicine

    School of Medicine and Health Sciences

    The
    George Washington University

    800
    22nd St NW, Suite 8880 | Washington, DC 20052

    (202)
    994 9547 | avillagra@gwu.edu

     

    Recipient

 

    	2

     

    

 

EXHIBIT
A – Research Plan

 

Dr.
Villagra will write in vitro assays related to the Materials. No in vivo studies are contemplated in this MTA.

 

    	3

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