Document:

Exhibit 10.11

 

SMALL BUSINESS INNOVATION RESEARCH (SBIR)
PROGRAM

 

RESEARCH AGREEMENT AND SUBCONTRACT

BETWEEN

GEORGETOWN UNIVERSITY

AND

SHUTTLE PHARMACEUTICALS, LLC.

PURSUANT TO

AWARD NUMBER HHSN261201600027C - NCI CONTROL NUMBER:N43CO-2016-00027

 

("Predictive biomarkers of prostate
cancer patient sensitivity for radiation late effect")

 

	SUBGRANTEE:	Georgetown University
	 	 
	ADDRESS:	37th And O Streets, NW
	 	Washington, DC 20057
	 	 
	SUBGRANT PERIOD:	September 19, 2016 - September 18. 2017
	 	 
	ESTIMATED COST:	$100,000

 

PREAMBLE

 

This cost-reimbursable
Agreement is between Shuttle Pharmaceuticals, LLC, a small business concern organized as a Limited Liability Company under
the laws of the state of Maryland and having a principal place of business at One Research Court, Suite 450 Rockville, MD 20850
("Sponsor") and GEORGETOWN UNIVERSITY, a nonprofit institution of higher education organized as a non-stock corporation
under federal charter and whose principal place of business is situated at 37th and O Streets, N.W., Washington, D.C., U.S.A. ("Georgetown"
or "Subgrantee"). It constitutes a Subgrant for the transfer of substantive programmatic work under AWARD NO.
HHSN261201600027C - NCI CONTROL NO: N43CO-2016-00027 (Prime Agreement), which was issued to Sponsor by the National Institutes
of Health (NIH).

 

In consideration of the premises and other
good and valuable consideration, the receipt and sufficiency of which are acknowledged, and intending to be legally bound, the
parties expressly agree to the terms and conditions contained in this Agreement.

 

ARTICLE I. STATEMENT OF WORK

 

The Subgrantee agrees to undertake activities
in accordance with the Statement of Work appended as ATTACHMENT A.

 

     

     

    

 

ARTICLE II. KEY PERSONNEL

 

The activities to be performed under this
Agreement arc under the direction of Dr. Amrita K. Cheema. Should Dr. Cheema be unable to continue during the period of
performance of this Agreement, Sponsor reserves the right to approve or disapprove any successor recommended by the Subgrantee.

 

ARTICLE III. PERIOD OF PERFORMANCE

 

The effective period of performance of
this Agreement shall begin on September 19, 2016 and shall terminate on September 18, 2017.

 

ARTICLE IV. CONSIDERATION AND ALLOWABLE
COSTS

 

In return for the Subgrantee's performance
of the work required by ARTICLE I and agreement to abide by the terms contained in this Agreement, the Sponsor will reimburse
the Subgrantee for its actual allowable costs up to a ceiling amount of $100,000. The Subgrantee agrees not to invoice
for an amount in excess of $100,000 unless additional funds are obligated by formal written modification to this Agreement.
Costs shall be incurred in accordance with the Budget, which is appended as ATTACHMENT B and is an integral part of this
Agreement. The authorized amount will cover direct and indirect costs of the research, as detailed in the budget, ATTACHMENT
B. The allowability of direct and indirect costs will be in accordance with applicable 2 CFR 200. The Subgrantee is authorized
to move funds between line items in the Budget, provided that the total amount of expenditures docs not exceed funds currently
obligated by this Agreement and is within the policies stated in the NIH Grants Policy Statement.

 

Funds obligated are for the defined Period of Performance only,
as stated in Article III. Carryover of funds remaining at the end of this period is not automatic and must be asked for in a letter
to the Sponsor. Sponsor will seek the approval of NIH. Carryover funds to Subgrantee arc not available until such approval has
been received by Sponsor. Such approval will be forwarded to Subgrantee in a Modification to this agreement as detailed in Article
XXIII.

 

ARTICLE V. PAYMENT

 

		A.	Payments for performance under this Agreement shall be issued by
                                         the Sponsor to the Subgrantee on a cost reimbursable basis within 30 days of receipt
                                         of proper, approved invoice(s) in the Sponsor Office. Invoices should
                                         be submitted monthly and no less than quarterly.

 

		B.	To be considered proper, an invoice must contain
                                         the Agreement identification number (HHSN261201600027C), sufficiently itemize
                                         expenses for which the Subgrantee is invoicing, and contain an original dated approval
                                         signature of an authorized representative of the Subgrantee. This signature shall certify
                                         that the expenses recited in the invoice reflect actual expenditures consistent with
                                         the terms of this Agreement.

 

     

     

    

 

		C.	To be considered approved, an invoice must also bear the dated approval initials or signature of Scott
Grindrod, Ph.D. or his designee. The Sponsor Accounting Office shall seek to obtain this approval by submitting the invoice
to Peter Dritschilo, President and CFO after receipt.

 

		D.	Invoices shall be sent to:

 

Shuttle Pharmaceuticals, LLC.

One Research Court, Suite 450

Rockville, MD 20850

 

Payment shall be made to:

 

Georgetown University

and shall be sent to:

Sponsored Projects Financial Operation

2121 Wisconsin Ave., NW

4th Floor

Washington, DC 20007

Attention: Chief Accounting Officer

 

Tax ID: 53-0196603

 

		E.	Invoices that exceed cither the period of performance of this Agreement or the obligated amount of this Agreement may be considered
improper invoices and may be returned to the Subgrantee unpaid. Acceptance and payment by the Sponsor of any improper invoices
shall not be construed as a waiver of the Sponsor's right to return future improper invoices.

 

		F.	A final invoice clearly marked "FINAL" must be received within sixty (60) days of the close of the expiration date
of the award. Invoices received after this date may be considered improper invoices, and may be returned to the Subgrantee unpaid.

 

ARTICLE VI. RECORDS AND AUDIT

 

		A	Records for this Agreement arc to be retained by the Subgrantee for at least three years after final payment under this Agreement
and all pending matters arc closed. If an audit, litigation, or other action involving the records is started before the end of
the three year period, the records must be retained until all issues arising out of the action are resolved or until the end of
the three year period, whichever is later. The Subgrantee agrees to give the Sponsor, the National Institutes of Health, the Comptroller
General of the United States, or any of their authorized representatives access to these records and any other pertinent books,
documents, papers or other records, in order to make audits, examinations, excerpts and transcripts.

 

     

     

    

 

 

		B.	The Subgrantee agrees to comply with the requirements of 2 CFR 200 as appropriate. The Subgrantee further agrees to provide
the Sponsor with copies of any independent auditors' reports within 30 days of their receipt by the Subgrantee. Where the report
includes instances of non-compliance with federal laws and regulations, the Subgrantee shall provide copies of responses to the
report and a plan for corrective action.

 

ARTICLE VII. PUBLICATIONS

 

In the event either Party wishes to publish
or present any material from work performed under this Agreement, the Subgrantee agrees to submit a manuscript of the publication
or an abstract of the presentation to Dr. Scott Grindrod for comment at least thirty (30) days prior to submission for publication
or presentation.

 

The Subgrantee further agrees that when
publishing, or submitting for publication, in scientific, peer-reviewed or other scholarly publications, the Subgrantee shall acknowledge
the support of the National Institutes of Health whenever publicizing the work under this Subgrant in any media by including an
acknowledgement substantially as follows:

 

“The project described was supported
by Award Number (hhsn261201600027c) from the Shuttle Pharmaceuticals,
LLC. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Shuttle
Pharmaceuticals, LLC or the National Institutes of Health."

 

ARTICLE VIII. PATENTS AND INVENTIONS

 

Pursuant to the Bayh-Dole Act and Executive
Order 12591 (April 10, 1987), all recipients of Federal research funding (i.e., all Federal grantees and contractors and consortium
participants and other organizations receiving funds under Federal grants and contracts, whether small businesses, large businesses,
or non-profit organizations) are subject to the same invention reporting requirements and regulations. These are included in the
regulations issued by the Department of Commerce, found at 37 CFR Part 401.

 

For purposes of this Subgrant, Sponsor is
the grantor. Subgrantee will establish and implement an employee invention reporting policy to identify the parties who perform
work under this Subgrant and who may be reasonably expected to make inventions.

 

The determination of the rights of ownership
and disposition of inventions resulting from the performance of the work done under this Subgrant and the administration of such
inventions shall be in accordance with NIH policies and the Small Business Innovation Research (SBIR) agreement entered into by
and between the Parties dated 10/28/2016, attached hereto as ATTACHMENT C

 

ARTICLE IX. INDEMNIFICATION

 

The Subgrantee shall defend, indemnify and
hold the Sponsor, its officers, employees, and agents, harmless from any and all liability, loss, expenses (including reasonable
attorney's fees), or claims for injury or damages arising out of the performance of this Agreement but only in proportion to and
to the extent such liability, loss, expense, attorney's fees, or claims for injury or damages are caused by or result from the
negligent or intentional acts or omissions of the Subgrantee, its officers, employees, or agents.

 

     

     

    

 

 

The Sponsor shall defend, indemnify and
hold the Subgrantee, its officers, employees, and agents, harmless from any and all liability, loss, expenses (including reasonable
attorney's fees), or claims for injury or damages arising out of the performance of this Agreement but only in proportion to and
to the extent such liability, loss, expense, attorney's fees, or claims for injury or damages are caused by or result from the
negligent or intentional acts or omissions of die Sponsor, its officers, employees, or agents.

 

ARTICLE X. CERTIFICATION REGARDING DEBARMENT,
SUSPENSION, AND OTHER RESPONSIBILITY

MATTERS - PRIMARY COVERED TRANSACTIONS

 

		A.	The Subgrantee certifies to the best of its knowledge and
belief, that it and its principals:

 

		1.	Are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily
excluded by any Federal department or agency;

 

		2.	Have not within a three-year period preceding this agreement been convicted of or had a civil judgment
rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing
a public (Federal, State or local) transaction or contract under a public transaction; violation of Federal or State antitrust
statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements,
or receiving stolen property;

 

		3.	Are not presently indicted for or otherwise criminally or civilly charged by a governmental entity
(Federal, State, or local) with commission of any of the offenses enumerated in paragraph (2) of this certification; and

 

		4.	Have not within a three year period preceding this agreement had one or more public transactions
(Federal, State, or local) terminated for cause or default.

 

		B.	Where a prospective primary participant is unable to certify to any of the statements in this certification,
such prospective participant shall provide an explanation.

 

ARTICLE XL TERMINATION

 

		A.	Either Party may terminate this Agreement for cause or convenience by giving the other Party thirty
(30) days written notice.

 

		B.	In all instances of termination or suspension, the Subgrantee shall be given written notice of
the termination or suspension, including a written explanation of the reason(s) for such action. Where appropriate, the Subgrantee
shall be given reasonable time to cure any deficiency in its performance. If the deficiency is not corrected within a reasonable
time, as defined by the Sponsor in consultation with the Subgrantee, the Agreement may then be immediately terminated or suspended.

 

     

     

    

 

		C.	Upon receipt of a notice of termination or suspension as specified above, the Subgrantee shall take immediate action to minimize
all expenditures and obligations financed by this Agreement and shall cancel unliquidated obligations wherever possible. Except
as provided below, no further reimbursement shall be made after the effective date of termination or suspension. The Subgrantee
shall within 30 calendar days after the effective date of termination or suspension repay to the Sponsor all unexpended funds disbursed
by the Sponsor that are not otherwise obligated by a legally binding transaction applicable to this Agreement. Should the funds
paid by the Sponsor to the Subgrantee be insufficient to cover the Subgrantee's obligations in the legally binding transaction,
the Subgrantee may submit to the Sponsor within 60 calendar days after the effective date of termination or suspension a written
claim covering such obligations. The Sponsor Sponsored Accounting Office shall determine the amount(s) to be paid by the Sponsor
to the Subgrantee under such claims in accordance with the applicable cost principles.

 

ARTICLE XII. DISPUTES

 

		A.	There is no formal procedure established for resolving disputes between the Sponsor and the Subgrantee. It is Sponsor policy
to make every reasonable effort to resolve all issues fairly by negotiation without litigation. Any disputes arising under this
Agreement shall be brought to the attention of the Georgetown University Medical Center Office of Sponsored Research. Authority
for resolving such disputes on behalf of the Subgrantee shall reside with the Sr. Associate Vice President of the Office of Sponsored
Research or her designee.

 

		B.	This Article shall not be construed to limit the administrative or legal rights otherwise available to the parties in the event
of violations of the terms or conditions of this Agreement.

 

ARTICLE XIII. NOTICES

 

Any official notices required under the
terms of this Agreement shall be hand delivered or sent by Certified Mail, postage prepaid, return receipt requested, to the appropriate
individual and address listed below.

 

	For the Sponsor:	 	For the Subgrantee:
	 	 	 
	Peter Dritschilo, President and CFO	 	Marjan Mobini
	Shuttle Pharmaceuticals, Inc.	 	Sr. Grants & Contracts Officer
	One Research Court, Suite 450	 	Office of Sponsored Research
	Rockville, MD 20850	 	Georgetown University
	 	 	3300 Whitehaven Street, NW
	Phone: 	240-403-4212
    (Work)	 	Washington, DC 20007
	 	240-271-0642
    (Cell)	 	Tel: 202-687-7866
	Email:	peter.dritschllo@shuttlepharma.org	 	Email: mobinim@georgetown.edu

 

     

     

    

  

ARTICLE XIV. IRB APPROVAL

 

Research involving human subjects shall not be conducted under
this subgrant until Subgrantee has provided to Sponsor a properly completed "Protection of Human Subjects Assurance identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310), certifying IRB review and approval
of the protocol. The human subject certification can be met by submission of the Subgrantee's self designated form, provided that
it contains the information required by the "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration
of Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310). Certification/Declaration of Exemption", Form OMB
No. 0990-0263 (formerly Optional Form 310).

 

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

 

ARTICLE XV. REQUIRED EDUCATION IN THE
PROTECTION OF HUMAN

RESEARCH PARTICIPANTS

 

NIH policy requires education on the protection
of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a
complete description of the NIH Policy announcement on required education in the protection of human subject participants, the
Subgrantee should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 (Revised August 25, 2000)
at the following website:

 

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

 

The terms and conditions referencing Human
Subjects Assurance and Required Education in the Protection of Human Research Participants are in full force as if written in their
entirety and are made a part of this Subgrant.

 

ARTICLE XVI. HIPAA

 

Notwithstanding anything to the contrary
in this Agreement, all individually identifiable health information shall be treated as confidential by the parties in accordance
with all applicable federal, state or local laws and regulations governing the confidentiality and privacy of individually identifiable
health information, including without limitation, the HIPAA Privacy Regulation and any regulations and official guidelines promulgated
thereunder, and the parties agree to take such additional steps and/or to negotiate such amendments to this Agreement as may be
required to ensure that the parties are and remain in compliance with the HIPAA Privacy Regulation and official guidance. Institution
hereby certifies that it complies with all applicable HIPAA requirements.

 

     

     

    

 

ARTICLE XVII. INCORPORATED TERMS OF THE
PRIME AGREEMENT

 

This Agreement is subject, where applicable,
to the following terms and conditions of the Prime Agreement.

 

		1.	FAR 52. 252-2

		2.	Section G

		3.	Section H

		4.	Section I

 

These terms are in full force and effect
as if written in this Article in their entirety. Where the terms read or imply "The Government or the National Institutes
of Health" they shall be considered to read or imply "The Sponsor". Where they read or imply "The Grantee"
they shall be considered to read or imply "The Subgrantee". Where they read or imply a Sponsor official, they shall be
considered to read or imply the relevant Sponsor official.

 

These additional terms supplement the articles
of this Agreement. They do not replace or supersede nor are they replaced or superseded by the Articles of this Agreement. In
the event of a conflict between the Articles of this Agreement and these additional terms and conditions, a resolution shall be
achieved in accordance with ARTICLE XII.

 

ARTICLE XVIII. ATTACHMENTS

 

The following attachments are an integral
part of this Agreement:

 

	ATTACHMENT A.	Statement of Work
	ATTACHMENT B.	Budget
	ATTACHMENT C.	SBTR Agreement
	ATTACHMENT D.	(If applicable IRB Approval or IACUC Approval)

  

ARTICLE XIX. REPORTING REQUIREMENTS

 

Subgrantee's Principal Investigator will
provide to Dr. Scott Grindrod quarterly technical progress reports and a final technical report on all work to be performed
under this Agreement as required to fulfill reporting requirements under the Prime Award and to enable with the filing of the
continuation application of such award.

 

ARTICLE XX. INDEPENDENT CONTRACTOR

 

In performing activities under this Agreement,
Subgrantee shall be deemed to be and shall be an independent contractor and, as such, shall not be entitled to any benefits applicable
to employees of the Sponsor.

 

     

     

    

 

ARTICLE XXI. GOVERNING LAW

 

This Agreement shall be governed by the
laws of the District of Columbia.

 

ARTICLE XXII. WAIVER

 

No waiver of any term, provision or condition
of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further
or continuing waiver of any such term, provision or condition, or of any other term, provision, or condition of this Agreement.

 

ARTICLE XXIII. MODIFICATION OR AMENDMENT

 

No modification or amendment to this Agreement
shall be valid unless in writing, signed by an authorized representative of the Sponsor and an authorized representative of the
Subgrantee. Only designated individuals within the Georgetown University Medical Center, Office of Sponsored Research are authorized
to modify this Agreement for Georgetown.

 

ARTICLE XXIV. ENTIRE AGREEMENT

 

This writing contains the entire agreement
of the parties and there are no promises, understandings, or agreements of any kind pertaining to this Agreement other than those
written in this Agreement.

 

ARTICLE XXV. SEVERABILITY

 

In the event that any term or provision
of this Agreement or any application of a term or provision of this Agreement is deemed illegal, or unenforceable, the remainder
of this Agreement or the application of such a term or provision shall not be affected, except with regard to those persons or
circumstances to which it was specifically held invalid or unenforceable.

 

ARTICLE XXVI. ANTI-TERRORISM

 

The Subgrantee is reminded that U.S. Executive
Orders 13224 and U.S. Law prohibits transactions with, and the provision of resources and support to, individuals and organizations
associated with terrorism. It is the legal responsibility of die Subgrantee to ensure compliance with these Executive Orders and
Laws. This provision must be included in all subcontracts/subawards issued under this subgrant agreement.

 

ARTICLE XXVII. CAPTIONS OR HEADINGS

 

Captions or headings contained in this Agreement
are inserted only as a matter of convenience and do not in any way define, limit, or extend the scope or intent of this Agreement
or any term or provision of this Agreement.

 

     

     

    

 

ARTICLE XXVIII. COUNTERPARTS

 

This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

ARTICLE XXIX. CERTIFICATION REGARDING
FINANCIAL CONFLICTS 

OF INTEREST

 

In this Article, capitalized terms have
the meaning given to them in the Public Health Service's regulations on Promoting Objectivity In Research, codified in Title 42,
Part 50, Subpart F of the Code of Federal Regulations, as they may from time to time be amended ("PHS Regulations").
The Subgrantee certifies to the Sponsor that [check ONE statement below]:

 

x
Subgrantee has adopted Financial Conflicts of Interest policies
and procedures that comply with the PHS Regulations. Subgrantee will comply with the requirements of its own Financial Conflicts
of Interest policies and procedures with respect to its performance under this Agreement. Within 1 day of receipt of a "just
in time" notice from the Sponsor [or: of the execution of this Agreement], and thereafter within 30 days of discovering any
new Significant Financial Interests for its Investigators, Subrecipient shall report to the Sponsor any identified Financial Conflicts
of Interest for its Investigators.

 

The report will contain all elements required by the PHS Regulations[,
including: (i) Project/Contract number; (ii) principal investigator/project director; (iii) name of the Investigator with the
Financial Conflict of Interest; (iv) name of entity in which the Investigator has a Significant Financial Interest that gives
rise to a Financial Conflict of Interest; (v) nature of the financial interest; (vi) value of the financial interest, within dollar
ranges, or if the value cannot be readily determined through reference to public prices or other reasonable measures, a statement
to that effect; (vii) a description of how the financial interest relates to the PHS-funded research and the basis for the Subgrantee's
determination that the financial interest conflicts with such research; and (viii) a description of the key elements of the management
plan, including (a) the role and principal duties of the conflicted Investigator in the research project, (b) conditions
of the management plan, (c) how the management plan is designed to safeguard objectivity in the research project (d)
confirmation of the Investigator's agreement to the management plan. (e) how the management plan will be monitored
to ensure Investigator compliance, and (f) other information as needed].

 

 ̈
Subgrantee has not adopted Financial Conflicts of Interest policies
and procedures that comply with the PHS Regulations. In performing its obligations under this Agreement, Subgrantee will follow
Sponsor's Financial Conflicts of Interest Policy [http://ora.georgctown.edu/FCOIPolicyRequircments.html]. which will be incorporated
into the Subaward Agreement by reference. Subgrantee will require its Investigators to complete the Financial Conflicts of Interest
Disclosure forms provided by the Sponsor. Within 1 day of receipt of a "just in time" notice from the Sponsor [or: of
the execution of this Agreement], and thereafter within 30 days of discovering any new Significant Financial Interests of its Investigators,
Subrecipient shall report to the Sponsor any Significant Financial Interests reported by its Investigators. Subgrantee will ensure
that its Investigators provide full information to Sponsor regarding any Significant Financial Interests, in order for the Sponsor
to determine if such Significant Financial Interests are related to the research and constitute a Financial Conflict of Interest
and to make required reports to the funding agency. If Sponsor determines that any of Subgrantee's Investigators have Financial
Conflicts of Interest, Subgrantee will ensure that its Investigators comply with the terms of any conflict management plan(s) issued
by the Sponsor with respect to such Financial Conflicts of Interest.

 

     

     

    

 

ARTICLE XXX. ACCEPTANCE

 

This Agreement shall not be considered accepted
or effective until signed below by authorized representatives of both of the parties. By signing below, each individual warrants
that he or she is authorized to bind his or her organization to this Agreement.

 

The parties agree that this Agreement may be signed by either
party by electronic means. Neither party will challenge the legal effect of cither party's signature or the enforceability of this
Agreement solely because the signature is in electronic form.

 

	FOR SHUTTLE PHARMACEUTICALS, LLC.	 	FOR GEORGETOWN UNIVERSITY:
	 	 	 
	 	 	 
	/s/ Peter Dritschilo	 	/s/ Trudy Bright
	NAME: Peter Dritschilo,	 	NAME: Trudy Bright
	 	 	 
	TITLE: President and CFO	 	TITLE: Director, Office of Sponsored Research
	 	 	 
	Date: 	11/21/16	 	Date: 	11/22/2016

 

     

     

    

 

ATTACHMENT A.

STATEMENT OF WORK

 

     

     

    

 

Statement of Work (Phase I) Dated XX/XX/XXXX

Contract No. HHSNxxxxxxxx

 

[Blue – To be filled out by NCI STAFF]

 

STATEMENT OF WORK (Phase I)

 

	TITLE:	Predictive biomarkers for prostate cancer patient sensitivity
	 	for radiation late effects

 

	PRINCIPAL INVESTIGATOR(S):	Scott Grindrod, PhD
	PROJECT DURATION:	12 months
	COMPANY:	Shuttle Pharmaceuticals, Inc.
	SUBCONTRACTORS:	Georgetown University

 

		I.	Background Information and Objectives 

 

		A.	Background Information

 

Patients treated for
prostate cancer may experience treatment related late effects that adversely affect quality of life and may prove life-threatening.
The objective of this Phase I SBIR application is to determine the technical and commercial feasibility of a biomarker panel predictive
of radiation mediated late effects in patients treated for prostate cancer. We will develop a metabolite signature of radiation
responses in a cohort of patients undergoing stereotactic body radiation therapy (SBRT) for prostate cancer. Analysis of banked
plasma samples will be correlated with clinical outcomes to identify markers of urinary and gastrointestinal late effects for validation
in a larger clinical population to be proposed in a subsequent Phase II application. The Phase II effort will allow Shuttle Pharmaceuticals
to advance its proposed commercialization plan and to raise capital to support validation clinical trials leading to FDA approval.

 

Patients
treated with stereotactic body radiation therapy (SBRT) for prostate cancers on an IRB approved protocol have banked clinical specimens
and detailed monitoring of quality of life parameters. Sub-sets of these patients have developed urinary incontinence (Ul), symptomatic
urinary flare (USF), obstructed voiding symptoms/retention (UR) and radiation proctitis (RP). We have used high resolution mass
spectrometry based metabolomics/lipidomic profiling to analyze this unique cohort of patient samples and propose here, to leverage
our established analytical platform to advance product development and validation of a biomarker panel predictive of radiation
toxicities. Metabolites in plasma from a cohort of 100 de-identified patients will be analyzed
to develop a kit supporting metabolomic analysis to serve as a biomarker panel predictive of patient susceptibility for radiation
late effects.

 

		B.	Technical Objectives

 

The
three technical objectives of this proposal focus on determining the feasibility for developing a metabolite panel predictive of
clinical outcomes in prostate cancer patients treated with radiation therapy (SBRT). In Objective 1, we
will use technology in the Waters Center of Excellence at Georgetown University to perform metabolite analysis on de-identified,
bio-banked plasma samples from 100 patients. In the first objective, untargeted metabolite
profiles will be obtained and analyzed for correlations with clinical outcomes, including cancer recurrence, urinary tract injury
and rectal injury. Candidate metabolites will be validated and a metabolite "kit" will be designed and tested in Objective
2. Standard operating procedures (SOPs) will be prepared and purity, stability and storage
capacity will be tested. Objective 3 is to consolidate the intellectual property (metabolite
panels) within Georgetown University policies and obtain a license to develop and commercialize the biomarker panels. Submitting
a final report to NIH staff documenting success in achieving the Phase I milestones will allow preparation of a phase II application
to clinically validate the biomarker panel and support commercialization efforts.

 

     

     

    

 

Statement of Work (Phase I) Dated XX/XX/XXXX

Contract No. HHSNxxxxxxxx

 

Objective 1. Develop a metabolite biomarker panel of radiation
late effects.

 

Task 1.1. Perform untargeted metabolomics profiling of plasma
specimens using UPLC-ESI-QTOFMS.

 

Milestone 1.1. Metabolite raw data on clinical
samples from 100 patients

 

Task 1.2. Perform biostatistics analysis of raw data to identify
candidate metabolite signatures.

 

Milestone 1.2. Metabolite signatures for cancer
recurrence, urinary tract injury and rectal injury.

 

Task 1.3. Validate and evaluate
biomarker performance using SID-MRM-MS. Identify candidate molecules for biomarker development.

 

Milestone 1.3. Panels
of validated biomarkers that correlate to cancer recurrence, urinary injury and rectal injury (for kit development).

 

Objective 2. Design and test a metabolite "kit"
suitable for GLP clinical application

 

Task 2.1. Define the operating range of the biomarker assay.

 

Milestone 2.1. Accuracy
and precision of the assay is available for preparing standard operating procedures (SOPs).

 

Task 2.2. Determine the assay optimization and standardization.

 

Milestone 2.2. Purity, stability and storage capacity
data for selected metabolites will be used in SOPs.

 

Task 2.3. Determine robustness of the assay.

 

Milestone 2.3. Assay repeatability available for
the SOPs.

 

Objective 3. Review achieved
milestones, evaluate commercialization potential and advance a Phase II SBIR application for clinical trial validation of the biomarker

 

Task 3.1. Disclose intellectual property to the GU Office of
Technology Commercialization.

 

Milestone 3.1. Provisional patent application
submission.

 

Task 3.2. Prepare and submit the final report of Phase
I accomplishments.

 

Milestone 3.2. Written final report is accepted
by NIH staff allowing submission of a Phase II application.

 

		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.

 

     

     

    

 

Statement of Work (Phase I) Dated XX/XX/XXXX

Contract No. HHSNxxxxxxxx

 

		B.	Specific Requirements

 

Phase I Milestones and Timeline

 

	 	 	 	 	Months

    1-3	 	Months

    4-6	 	Months

    7-9	 	Months

    10-12
	Objective 1	 	 	 	******	 	******	 	 	 	 
	GU	 	Milestone
    1.1. Metabolite raw data on clinical samples from 100 patients	 	X	 	X	 	 	 	 
	SP/GU	 	Milestone
    1.2. Metabolite sianatures for cancer recurrence, urinary tract injury and rectal injury.	 	 	 	X	 	 	 	 
	SP	 	Milestone
    1.3. Panels of validated biomarkers for assay kit development.	 	 	 	X	 	X	 	X
	 	 	 	 	 	 	 	 	 	 	 
	Objective 2	 	 	 	 	 	******	 	******	 	 
	SP	 	Milestone
    2.1. Accuracy and precision of the assay for standard operating procedures (SOPs)	 	 	 	X	 	X	 	 
	SP	 	Milestone
    2.2. Puritv. stability and storaae capacity data for selected metabolites for SOPs.	 	 	 	X	 	X	 	 
	SP	 	Milestone
    2.3. Assay repeatability for SOPs.	 	 	 	 	 	X	 	 
	Objective 3	 	 	 	 	 	***	 	******	 	******
	SP/GU	 	Milestone
    3.1. Provisional patent application submission.	 	 	 	X	 	X	 	X
	SP	 	Milestone
    3.2. Written final report is accepted by NIH staff; submit a Phase II SBIR application.	 	 	 	 	 	X	 	X

 

SP = Work will be performed in Shuttle
Pharmaceuticals Laboratory/ Administrative Offices

 

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

 

     

     

    

 

ATTACHMENT B.

BUDGET

 

     

     

    

 

 

 

     

     

    

 

 

 

 

     

     

    

 

 

 

     

     

    

 

ATTACHMENT C.

SBIR AGREEMENTExhibit 10.12

 

Small Business Innovation Research
(SBIR) Program

 

Phase I

 

Allocation of Rights in Intellectual
Property and Rights to

Carry Out Follow-on Research, Development, or Commercialization

 

This SBIR Phase I agreement (“Agreement”) between
Shuttle Pharmaceuticals, Inc., a small business concern organized as corporation under the laws of Maryland having a principal
place of business at One Research Court, Suite 450, Rockville, MD 20850, (“SBC”) and Georgetown University, a nonprofit
institution of higher education organized as a non-stock corporation under federal charter and whose principal place of business
is situated at 37th and O Streets, N.W., Washington, D.C., U.S.A. (hereinafter called “Georgetown”) is entered into
for the purpose of allocating between the parties certain rights relating to an SBIR project to be carried out by SBC and Georgetown
(hereinafter individually referred to as Party or collectively as “Parties”) under an SBIR funding agreement awarded
by the National Institutes of Health (“AGENCY”) to SBC, (HHSN261600038C) to fund a proposal entitled, “Cell
and Animal Based Models to Advance Health Disparity Research.”

 

		1.	Applicability of this Agreement.

 

		(a)	This Agreement shall be applicable only to matters relating to the SBIR phase I project referred to in the preamble above.

 

		(b)	SBC shall promptly provide a copy of the funding agreement to Georgetown, and SBC will make a sub-award to Georgetown in accordance
with the funding agreement, the proposal, and this Agreement. If the terms of such funding agreement appear to be inconsistent
with the provisions of this Agreement, the parties will attempt in good faith to resolve any such inconsistencies. However, if
such resolution is not achieved within a reasonable period, SBC shall not be obligated to award nor Georgetown to accept the subaward,
as the case may be. If a subaward is made by SBC and accepted by Georgetown, this Agreement shall not be applicable to contradict
the terms of such subaward or of the funding agreement awarded by AGENCY to SBC except on the grounds of fraud, misrepresentation,
or mistake, but shall be considered to resolve ambiguities in the terms of the subaward.

 

		(c)	The provisions of this Agreement shall apply to any and all consultants, subcontractors, independent contractors, or other
individuals employed by SBC or Georgetown for the purposes of this SBIR project.

 

		(d)	It is understood that performance of the research contemplated in the SBIR project, as outlined in Attachment A, attached hereto,
shall be carried out in the laboratory of Dr. Bhaskar Kallakury, who is a Professor and Researcher in the Pathology Department
at Georgetown.

 

		2.	Background Intellectual Property.

 

		(a)	“Background Intellectual Property” means property and the legal right therein of either or both Parties developed
before or independent of this Agreement including inventions, patent applications, patents, copyrights, trademarks, mask works,
trade secrets and any information embodying proprietary data such as technical data and computer software.

 

    	 	 	1

     

    

 

		(b)	This agreement shall not be construed as implying that either Party hereto shall have the right to use Background Intellectual
Property of the other in connection with this SBIR except as otherwise provided hereunder..

 

		(c)	Georgetown’s Background Intellectual Property that will be used in connection with the research and development activities
for this SBIR project is in whole or part set forth in Attachment B, attached hereto (also referred to as “Licensed Technology”).
Georgetown is the owner of certain cell lines, research material, intellectual property, know-how, “Conditionally Reprogrammed
Cells” (also referred to as “CRC”) and CRC cultures, and CRC conditioned media, as may be described in the patent
applications and/or further listed and/or defined in Exhibit B pertaining to what is also collectively referred to as “CRC
Technology.” CRC Technology is exclusively licensed to a commercial partner (“Licensee”). Georgetown’s Licensee
has certain restrictions on third party use of CRC Technology. Based upon the permitted uses as set forth in this Agreement and
permission granted by Licensee for the use of the Licensed Technology hereunder, applicable solely with respect to initial discovery
under this Phase I SBIR program, Georgetown grants SBC and SBC hereby accepts the rights to use CRC Technology and cells transformed
under the research plan with CRC Technology solely for non- commercial use that is limited to academic research, education or other
scholarly purposes with the following restrictions: a) research material and research material derived through CRC Technology shall
not be used in humans; b) research material and research material derived through CRC Technology may not be further transferred
without Georgetown’s express written permission; and c) research material and research material derived through CRC Technology
shall not be used for any “Commercial Purpose” which shall include without limitation (i) for-profit sponsored research,
other than the conditions as outlined hereunder with respect to the research and development activities under this SBIR; and/or
(ii) fee-for-service and other activities, including without limitation, drug and chemical screening and profiling, proficiency
testing, manufacturing and quality control, and development of diagnostic and therapeutic products and services. For the sake of
clarity to this section, should a non-profit, governmental institution, or commercial entity seek to engage in sponsored research
with SBC, and said sponsor require a license to practice the patent rights set forth in Attachment B or Licensed Technology as
part of or as an outcome of the sponsored research, then the Licensee of the CRC technology shall have the sole authority and responsibility
for providing a sublicense to said sponsor under market-appropriate terms. In the event the Parties hereto seek to engage in a
Phase II or Phase III SBIR submission or agreement, the use of Licensed Technology shall be re-negotiated and subject to a license
from Licensee who reserves the right to enter at that time.

 

		3.	Project Intellectual Property.

 

		(a)	“Project Intellectual Property” means the legal rights relating to inventions (including Subject Inventions as
defined in 37 CFR 401), patent applications, patents, copyrights, trademarks, mask works, trade secrets, and any other legally
protectable information, including computer software, first made or generated during the performance of this SBIR Agreement.

 

    	D-2	 	 

     

    

 

		(b)	The rights of the Parties to Project Intellectual Property made by their respective employees in the performance of this SBIR
Agreement shall be as set forth in the Patent rights clause of 37 CFR 401.14.

 

Project Intellectual Property shall be owned by the inventor
of such Project Intellectual Property, as defined under United States patent law. Ownership shall follow inventorship. Jointly
made or generated Project Intellectual Property shall be jointly owned by the Parties. Each Party may obtain title to Project Intellectual
Property made by the other Party and not elected by said Party.

 

The Parties agree that the Government shall have an irrevocable,
nontransferable, royalty-free, nonexclusive license in all Project Intellectual Property, but only for the same purposes as the
license respecting Subject Inventions that the Federal Government holds under the Patent rights clause of 37 CFR 401.14(b).

 

		(c)	The Parties agree to disclose to each other, in writing, each and every Subject Invention and Project Intellectual Property,
which may be patentable or otherwise protectable under the United States patent laws in Title 35, U.S.C, which arise out of the
SBIR funded project. The Parties acknowledge that they will disclose Subject Inventions and Project Intellectual Property to each
other within two (2) months after their respective inventor(s) first disclose the invention in writing, subject to confidentiality
if necessary to maintain patentability of the Subject Invention and Project Intellectual Property.

 

		(d)	Each Party hereto may use Project Intellectual Property of the other nonexclusively and without compensation solely in connection
with the non-commercial research or development activities for this SBIR I project, including inclusion in SBIR I project reports
to the AGENCY.

 

		(e)	SBC will have an option to commercialize the Project Intellectual Property of Georgetown, subject to any rights of the Government
or other sponsors as follows:

 

		(1)	SBC shall receive a non-exclusive, royalty free license to use Project Intellectual Property developed solely or jointly by
Georgetown for non-profit, academic or purely research purposes only in accordance with the restrictions set forth in Section 2
(c) and not for any Commercial Purpose without prior written permission from Georgetown. Any publication related to Project Intellectual
Property shall acknowledge the original source of the materials, data and/or other intellectual property used therein and ownership
by Georgetown as well as license by Licensee, as appropriate. SBC shall receive an exclusive option (“Option”) to negotiate
a non- exclusive or exclusive, royalty-bearing commercial license to such Project Intellectual Property,. The Option shall be for
an initial option period of six (6) months after such invention has been promptly reported to SBC (the “Option Period”),
as reporting is set forth in Section 3(c) herein, provided that during the Option Period, SBC shall reimburse Georgetown for its
reasonable out-of-pocket expenses for pursuing and maintaining patent or other intellectual property protection for the Project
Intellectual Property. Except with the written consent of SBC, Georgetown will not voluntarily discontinue the pursuit and maintenance
of any US patent protection during the Option Period. SBC may terminate the Option at will by giving written notice to Georgetown
within the Option Period in which case Project Intellectual Property rights in Georgetown shall revert to Georgetown. At any time
prior to the expiration or termination of the Option, SBC may exercise such Option by giving written notice to Georgetown, whereupon
the Parties will promptly and in good faith enter into negotiations for an exclusive license to Georgetown’s rights in Project
Intellectual Property. The terms of such license shall include, but not be limited to: (i) payment of reasonable royalties to Georgetown
and/or Licensee on sales or leases of products or services which embody, or the development, manufacture or use of which involves
employment of Project Intellectual Property; (ii) reimbursement by SBC of reasonable expenses incurred by Georgetown in seeking
and maintaining patent or other intellectual property protection for the Project Intellectual Property; (iii) reasonable due diligence
milestones and (iv) insurance and indemnity provisions reasonably acceptable to Georgetown’s insurance carrier.

 

    	 	 	3

     

    

 

		(2)	Georgetown shall receive a non-exclusive, royalty free license to use Project Intellectual Property owned and developed jointly
by SBC and Georgetown for all purposes, subject to Licensee restrictions as applicable, up to and unless SBC exercises its Option,
in which case the rights of the Parties shall be governed by the terms and conditions of such Option and ensuing license and/or
other agreement as applicable. Any publication related to Project Intellectual Property shall acknowledge the original source of
the PPEC and ownership by SBC.
	 	 	 

		(3)	Where more than one royalty might otherwise be due in respect of any product or service under a license granted pursuant to
this Agreement, the Parties shall take such stacked royalty(ies) into good faith consideration in their negotiations with respect
to such product or service.

 

		4.	Follow-on Research or Development

 

All follow-on work, including any licenses, contracts,
subcontracts, sublicenses or arrangements of any type, shall contain appropriate provisions to implement the Project Intellectual
Property rights provisions and other provisions of this Agreement and insure that the Parties and the Government obtain and retain
such rights granted herein in all future resulting research, development, or commercialization work.

 

		5.	Confidentiality/Publication.

 

		(a)	Background Intellectual Property, as well as other proprietary or confidential information of a Party disclosed orally or in
tangible form to the other Party in connection with this SBIR project shall be reduced to writing (within thirty days of oral disclosures),
marked “Confidential,” and received and held in confidence by the receiving party for a period of three (3) years from
the date of disclosure. The following information shall not be considered confidential:

 

i)  information that is
now in the public domain or subsequently enters into the public domain, except through breach of this Agreement by receiving party;

 

    	D-4	 	 

     

    

 

ii)  information that
was in receiving party’s possession prior to disclosure by disclosing party hereunder as evidenced by written records, and was
not acquired directly or indirectly from disclosing party;

 

iii)  information that
was developed by or for receiving party from its own independent sources as evidenced by written records;

 

iv)  information that
receiving party receives from any third party not under any obligation to disclosing party to keep such information confidential;
and

 

v)  information that is
required to be disclosed by applicable statute or regulation or by judicial or administrative process, provided that receiving
party shall use reasonable efforts under the circumstances to notify disclosing party of such requirement so as to provide disclosing
party the opportunity to obtain such protective orders or other relief as the compelling court or other entity may grant,

 

		(b)	Subject to the terms of paragraph (a) above, either Party may publish its results from this SBIR project and each Party agrees
to provide another copy of any such publications within thirty (30) days of submission to provide the other Party time to review
the proposed publications, identify material on which patent applications should be filed, and submit other comments. Each Party
will give serious and good-faith consideration to any comments received from the other.

 

		6.	Liability.

 

		(a)	Each Party disclaims all warranties running to the other or through the other to third parties, whether express or implied,
including without limitation warranties of merchantability, fitness for a particular purpose, and freedom from infringement, as
to any information, result, design, prototype, product or process deriving directly or indirectly and in whole or part from such
Party in connection with this SBIR project.

 

		(b)	SBC will indemnify and hold harmless Georgetown with regard to any claims arising in connection with the results or performance
of this SBIR project by or under the authority of SBC. The Parties will indemnify and hold harmless the Government with regard
to any claims arising in connection with the results or performance of this SBIR project.

 

		(c)	Each Party hereby assumes any and all risk of personal injury and property damage attributable to the negligent acts or omissions
of that Party and the officers, employees, and agents thereof.

 

		7.	Termination.

 

		(d)	(a)    This Agreement may be terminated by either Party upon forty-five (45) days written notice to the other
Party. This Agreement may also be terminated by either Party in the event of the failure of the other Party to comply with the
terms of this Agreement. In the event of termination, the Parties shall retain all rights to Project Intellectual Property developed
up to and through the effective date of termination, including SBC’s right to the Option under the terms of the Agreement
that may have accrued prior to termination. In the event of termination by SBC, SBC shall reimburse Georgetown for all reasonable
expenses or uncancellable commitments incurred as of the date of notice of termination but not to exceed the total amount committed
under this agreement. The confidentiality, use, and/or non-disclosure obligations of this Agreement shall survive any termination
of this Agreement.

 

    	 	 	5

     

    

 

		8.	Separability of Provisions/Counterparts.

 

The provisions of this agreement are separable
and in the event that any of its provisions are determined to be invalid or unenforceable by a court of competent jurisdiction,
such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions. This
Agreement may be executed via facsimile or via email of scanned signed copies and in counterparts, each of which shall be deemed
an original and both of which, when taken together, shall constitute a single instrument.

 

	AGREED TO AND ACCEPTED:
	 
	Small Business Concern
	 
	Shuttle Pharmaceuticals, Inc.

 

	By:	/s/ Peter Dritschilo	 	Date:	1/23/2017

 

	Print Name: Peter Dritschilo MBA
	 
	 
	 
	Title: President & CFO
	 
	 
	Georgetown University

 

	By:	/s/ Claudia Stewart	 	Date:	1/26/17	 

 

	Claudia Stewart	 
	 	 
	Vice President for Technology Commercialization	 
	 	 
	Georgetown University	 
	 	 
	Read and Acknowledged by Dr. Bhaskar Kallakury	 
	 	 
	Of Georgetown University	 
	 	 
	/s/ Dr. Bhaskar Kallakury	 

 

	Date:	1/23/17	 

 

    	D-6	 	 

     

    

 

Attachment A

 

Statement of Work

 

STATEMENT OF WORK (Phase  I) for the
GU Sub-Contract

 

	TITLE:	Cell-based models for prostate cancer health disparity research

	PRINCIPAL INVESTIGATOR(S):	Johng S. Rhim, MD Prime Contract to Shuttle Pharmaceuticals, Inc.

 

	 	Bhaskar Kallkury, MD, PhD sub-Contract to GU
	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 blo-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 the 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. We will extend technology developed by colleagues at Georgetown University for growing “conditional reprogrammed
cells” to clinical application for potential use in precision medicine. In the first objective, three previously harvested,
de-identified and bio-banked prostate cells from AA patients will be grown and characterized in a process that will develop standard
operating protocols and optimal media conditions. The second objective will be to determine if modifications of growth medium can
promote growth without feeder layer cells to enhance wider applications for the AA cell lines. The third objective is to consolidate
the intellectual property (cell-lines) within Georgetown University policies and obtain a license to develop and commercialize
the cell lines for research and drug development in personalized medicine. Achieving the milestones for the phase I contract should
allow SBIR staff to judge the feasibility for establishing 50 prostate epithelial cell lines from AA patients through a phase II
contract that will include a commercialization plan for the prostate cell lines.

 

Objective 1: Grow paired cancer
and normal epithelial cell line from AA prostate tumors and normal biopsy specimens bio-banked on protocol IRB protocol #
2012-163. GU will perform only items identified in bold type. GU will provide data for quarterly reporting by Shuttle to NIH.
GU will assist in preparing SOPs for cell collection and growth.

 

Task 1.1. (performed by
GU under sub-contract) Establish malignant and non-malignant cell lines from banked AA prostatectomy specimens.

 

    	 	 	7

     

    

 

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

 

Task 1.2.
(performed by Shuttle) Characterize and annotate AA cells.

Milestone
1.2. Have full characterization of established AA cell lines by cell origin, cell growth > 30 passages, capacity to form
xenograft tumors, karyotype at early and late passages, expression of prostate tissue and tumor specific markers, STR analysis
to authenticate the established cell lines and mycoplasma testing

 

Task
1.3. (performed by GU under sub-contract) Expand early passages of CRCs for freezing and banking in the CRC bio-repository.

Milestone
1.3. 50 vials of each normal/tumor pair with l-2xl0^6cells/vial will be frozen and banked.

 

Task
1.4. (performed by GU under sub-contract) Prepare written protocols for establishing cell lines and standard operating procedures
(SOPs) for prostatectomy specimen processing and tissue acquisition for AA cell growth, maintenance, quality assurance and annotation.

 

Milestone
1.4. Have written protocols available for establishing AA cell lines and cell annotation. Provide complete annotation reports
for AA cell lines analyzed in this Phase I effort.

 

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 SO flasks. Test effects of graded concentrations of conditioned medium on AA cells using telomerase and cell growth assays.

 

Milestone
2.1.1 Results of effects of conditioned medium and concentrated conditioned medium on cellular growth.

Milestone
2.1.2 Determine optimal conditioned medium supplement for AA prostate CRC cell growth based on telomerase assay and confirmed
with a cell growth assay.

 

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

Milestone
2.2. A proprietary formula for concentrations of growth factors needed to promote efficient growth of AA CRC cultures using
telomerase assays and cell growth assays.

 

Task 2.3.
Compare cell characteristics under different growth conditions.

Milestone
2.3. The panel of growth, tumorigenicity, tissue and tumor tumor marker expression and STR analysis are available for paired
cell lines.

 

Objective
3: Complete a licensing agreement with Georgetown University for rights for commercialization of AA derived cell to be established
in Phase II. Prepare and submit a Phase II application.

 

Task 3.1
Negotiate a license from Georgetown University (or sublicense from Propagenlx) for marketing

rights for
AA paired prostate cell lines.

Milestone
3.1 Georgetown University OTC licenses marketing rights for the AA cells or Propagenix sub- licenses marketing rights to Shuttle
Pharmaceuticals. 

 

    	D-8	 	 

     

    

 

Task 3.2
Prepare and submit the final Phase I report with the licensing agreement to SBIR administration.

Milestone
3.3 Phase I milestones are met and support the technical and commercial feasibility to advance to Phase II.

 

Task 3.3
Submit the Phase II SBIR application.

Milestone
3.3 Phase II award allows continued work to establish 50 paired prostate cell lines from AA patients.

 

		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

 

    	 	 	9

     

    

 

Phase I
Milestones and Timeline

(Please feel free to use format
appropriate for your project)

 

	 	 	 	Months	Months	Months
	 	 	 	1-4	4-6	7-9
	 	 	 	 	 	 
	Objective 1	 	 	******	******	***
	 	 	 	 	 	 
	GU	Milestone 1.1. 3 paired cell cultures are expand and frozen (20 vials for each cell line)	 	X	 	 
	 		 	 	 	 
	Shuttle	Milestone 1.2. Characterization AA cell lines	 	 	X	 
	 	 	 	 	 	 
	GU	Milestone 1.3. 50 vials of each characterized normal/tumor cell line will be frozen and banked	 	 	 	X
	 	 	 	 	 	 
	Objective 2	 	 	***	******	******
	 	 	 	 	 	 
	Shuttle	Milestone 2.1. Effects of conditioned medium and concentrated conditioned medium are available	 	 	X	X
	 	 	 	 	 	 
	Shuttle	Milestone 2.2. A proprietary formula for defined concentrations of growth factors is developed	 	 	 	X
	 	 	 	 	 	 
	Shuttle	Milestone 2.3. Growth, tumorigenicity. and cell markers are available.	 	 	 	X
	 	 	 	 	 	 
	Objective 3	 	 	 	***	******
	 	 	 	 	 	 
	Shuttle	Milestone 3.1. GU OTC (or Propagenix) licenses marketing rights for the AA cells to Shuttle	 	 	X	X
	 	 	 	 	 	 
	Shuttle	Milestone 3.3. Phase I milestones are met and a Phase II application may advance	 	 	 	X
	 	 	 	 	 	 
	Pending	Milestone 3.3. Phase II award application allows work to establish 50 paired AA prostate cell lines	 	 	 	X

 

    	D-10	 	 

     

    

 

Attachment B

 

Georgetown Background Intellectual Property

 

Conditionally Reprogrammed Cells (“CRC”),
CRC Technology, know how, analysis and methodologies related thereto as described in:

 

Proc Natl Acad Sci U S A. 2012
Dec 4;109(49):20035-40

 

And protected under the following patent
applications (GU Ref. No.: 2011-006), which are exclusively licensed to Propagenix Inc,:

 

		·	Prov.Appl. No.: 61/413,291

		·	Prov. Appl. No.: 61/474,901

		·	PCT Appl. No.: US11/060378 (and foreign filings in Canada (2,817,712); Europe (11839723.1); Japan
(2013-538933); and Hong Kong (13/885,078))

		·	US Application No.: 13/885,078, 9,279,106 “Immortalization of Epithelial Cells and Methods
of Use”

		·	US Con’t14/498,089

		·	US Con’t 15/040,770

		·	US Con’t 15/040,783

 

For purposes of this Agreement, CRC
Conditioned Madia shall be defined as: media described within the above patent(s), without limitation, a calcium containing basal
media that has been incubated with division-arrested NIH-3T3 J2 cells, plus addition of an inhibitor of Rho Kinase (ROCK), whether
sold as a mixture or as a separate component for the purpose of reconstituting CRC Conditioned Media. Patentable components or
subsets of components shall be treated as derivatives.

 

For purposes of this Agreement, CRC
Cultures shall be defined as: normal or diseased primary epithelial cells, tumor cells, or any other type of cell type from
any organism, expanded using the methods described in the above patent(s), including without limitation, either co-culture or division-arrested
J2 cells in calcium-containing media plus ROCK inhibitor, or CRC Conditioned Media, and any derivatives.

 

    	 	 	11

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