EXHIBIT 10.2

 

EXECUTION COPY

 

RESEARCH AGREEMENT

NO. 10028857

 

BY AND BETWEEN

BIORESTORATIVE THERAPIES, INC.

AND

THE UNIVERSITY OF UTAH

 

This Research Agreement (“Agreement”) is entered into and effective as of June
15, 2012, by and between BioRestorative Therapies, Inc., a Nevada corporation
(Tax ID #91-1835664) having its principal place of business at 555 Heritage
Drive, Jupiter, FL 33458 (“Sponsor”), and the University of Utah, a body politic
and corporate of the State of Utah (“University”).

 

RECITALS

 

WHEREAS, Sponsor wishes to have certain research services performed in
accordance with the scope of work outlined in this Agreement; and

 

WHEREAS, the performance of such research is consistent, compatible and
beneficial to the academic role and mission of University as an institution of
higher education; and

 

WHEREAS, University is qualified to provide such research services.

 

AGREEMENT

 

NOW, THEREFORE, for and in consideration of the mutual covenants, conditions and
undertakings herein set forth, the parties agree as follows:

 

1.           Scope of Work. University agrees to perform for Sponsor certain
research (“Research”) described in the Scope of Work set forth in Appendix A,
which is attached hereto and incorporated herein by this reference (the
“Project”).

 

2.           Period of Performance. The Project period under this Agreement is
intended to commence as of June 15, 2012 (the “Effective Date”) and continue
until June 14, 2015, subject to earlier termination as hereinafter provided and
subject to extension for additional periods of performance upon written approval
by Sponsor and University (the “Term”).

 

3.           Compensation and Payment.

 

3.1           Compensation. During the Term, Sponsor shall pay to University a
fee at the rate of five hundred thousand dollars ($500,000) for each twelve (12)
month period of this Agreement (“Compensation”) for performance of the Research
under this Agreement. A budget itemizing the costs for providing the Research is
set forth in Appendix B, which is attached hereto and incorporated herein by
this reference.

 

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3.2           Payment. Sponsor shall pay the Compensation at the rate of
forty-one thousand six hundred sixty-seven dollars ($41,667) per month on the
fifteenth day of each month during the Term.

 

Compensation checks shall be payable to “The University of Utah” and shall be
delivered to:

 

GARY S. GLEDHILL

UNIVERSITY OF UTAH

RESEARCH ACCOUNTING

201 PRESIDENT’S CIRCLE, ROOM 406

SALT LAKE CITY UT 84112-9020

 

4.           Technical Supervision.

 

4.1       Supervision by Sponsor. The person with primary responsibility on
behalf of Sponsor for supervision of the performance of the Research shall be
Francisco Silva or such other person as may be designated by Sponsor, who shall
have primary responsibility and authority for technical supervision of the
Project.

 

4.2       Supervision by University. The person with primary responsibility for
supervision of the performance of the Research on behalf of University shall be
Dr. Amit Patel, MD. No other person shall replace or substitute for him in the
supervisory responsibilities hereunder without the prior written approval of
University, which may be granted or withheld at University’s sole discretion.
Subject to and to the extent consistent with this Agreement, University
acknowledges and agrees that Sponsor shall have the right to control the
Project.

 

5.           Reporting Requirements. University shall provide written reports to
Sponsor on the progress of the performance of Research on a quarterly basis
within thirty (30) days following the end of each calendar quarter. A final
written report shall be furnished to Sponsor upon completion of the Research or
termination of this Agreement within sixty (60) days of the last day of the
Project period or termination, as the case may be, and after the final payment
has been received.

 

6.           Equipment. All equipment, instruments and materials purchased or
used by University in connection with performance of the Research shall at all
times remain under the sole control and ownership of University.

 

7.           Publication and Confidentiality.

 

7.1          Publication.

 

(a)          In furtherance of University’s role as a public institution of
higher education, it is necessary that significant results of research
activities be reasonably available for publication by University in academic
publications and inclusion in research grant applications, and Sponsor
acknowledges that University may publish and include the results of research
conducted in connection with this Agreement, as well as research previously
conducted in connection with the Scope of Work, including in connection with the
Patent being obtained by Sponsor pursuant to that certain Assignment Agreement
of even date between University of Utah Research Foundation and Sponsor (“Prior
Research”), for such purposes.

 

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Notwithstanding the foregoing, University agrees that it shall not publish or
include the results of research conducted in connection with this Agreement or
Prior Research for such purposes, without the prior written consent of Sponsor,
unless and until it shall have followed the procedures set forth in paragraph
(b) hereof.

 

(b)          In the event University wishes to publish research results it
creates under this Agreement or Prior Research in academic publications or
include such research results in research grant applications, University shall
first provide to Sponsor written notice of University’s intent to publish or
include and a draft of such publication or application. Sponsor shall have
thirty (30) days after receipt of the draft publication or application to
request in writing the removal of portions deemed by Sponsor to contain
confidential, proprietary or patentable material owned by Sponsor. If University
receives Sponsor’s written response to the notice of intent to publish or
include within the thirty (30) day period, University shall give good faith
consideration to such request but shall not be required to remove the portions
deemed by Sponsor to contain confidential, proprietary or patentable material.
If University does not receive Sponsor’s written response to the notice of
intent to publish or include within the thirty (30) day period, then Sponsor
shall be deemed to have consented to such publication. The foregoing shall apply
to each draft of each publication and application that University intends to
submit for publication or approval. University shall deliver to Sponsor copies
of any and all comments received with regard to its draft publications and its
applications.

 

(c)          Information supplied to University by Sponsor and identified by
Sponsor as confidential, proprietary or patentable information shall not be
included in any material published by University without prior written consent
of Sponsor.

 

7.2          Confidentiality.

 

(a)          In view of the confidential and proprietary nature of the
information that will be disclosed or obtained in the performance of this
Agreement, it is hereby understood and agreed that:

 

(i)          Except as set forth in Sections 7.1, 7.2 and 10.1(b), University
shall treat as confidential, and not use or disclose, any information received
from Sponsor or otherwise obtained in connection with its Research and Prior
Research, whether from third parties or otherwise (“Confidential Information”).
For sake of clarity, the foregoing shall not restrict University from publishing
or using the results of research it creates under this Agreement or Prior
Research pursuant to the provisions of Section 7.1.

 

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(ii)         University shall notify its faculty, employees and agents that all
Confidential Information is confidential, and shall disclose Confidential
Information only to such of its faculty, employees and agents who have a “need
to know”.

 

(iii)        Except as set forth in Sections 7.1, 7.2 and 10.1(b) hereof,
neither University nor its faculty, employees or agents shall publish, submit a
publication or grant proposal, or otherwise disclose the results of any Research
performed under this Agreement or Prior Research without the prior written
consent of Sponsor.

 

(iv)        Except as set forth in Sections 7.1, 7.2 and 10.1(b), University
shall not use, practice, or exploit any Confidential Information without the
prior written consent of Sponsor.

 

(v)         Nothing in this Agreement shall obligate Sponsor to disclose any
particular information to University.

 

(b)          Notwithstanding the foregoing, Sponsor acknowledges that University
is a governmental entity subject to the Government Records Access and Management
Act, Utah Code §§ 63G-2-101 to 901, as amended (“GRAMA”) and Utah Code §§
53B-16-301 to -305 as amended. Under GRAMA certain records within University’s
possession or control, including, without limitation, this Agreement, may be
subject to public disclosure; and University’s confidentiality obligations shall
be subject in all respects to compliance with GRAMA.   Pursuant to GRAMA,
Sponsor may submit a single claim of business confidentiality concerning
confidential business records exchanged during the Project with a concise
statement of reasons supporting such claim. Notwithstanding any provision to the
contrary in this Agreement, University may disclose any information or record to
the extent required by GRAMA or as otherwise required by law.  University
acknowledges and agrees that it has been advised by Sponsor that (i) the
information set forth in Annex A to this Agreement and all records relating
thereto constitute trade secrets and confidential and proprietary information of
Sponsor, (ii) Sponsor intends to commercialize the materials that are being
developed pursuant to the Project and the disclosure of the information set
forth in the annexes would have a material adverse effect upon its ability to
accomplish such desire, (iii) the disclosure of the information set forth in the
annexes to this Agreement and the records relating thereto will have a material
adverse effect on Sponsor’s business and prospects and will result in unfair
competitive injury to Sponsor and (iv) such information and records need to be
protected from disclosure. The foregoing constitutes Sponsor’s written claim of
business confidentiality and a concise statement of reasons supporting the claim
of business confidentiality for purposes of Section 63G-2-309 of GRAMA with
respect to the referenced materials.

 

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(c)          Notwithstanding the foregoing, University may disclose Confidential
Information if:

 

(i)such information is already or comes within the public domain (other than by
breach of a duty of confidence owed to any person);

 

(ii)disclosure has been approved by the written consent of Sponsor;

 

(iii)University is required to provide such information by law or under a court
or other administrative agency ruling; or

 

(iv)to the extent required by federal or state law or regulation of any
governmental authority having jurisdiction over any of the parties in connection
with the Project;

 

Prior to disclosing any Confidential Information, University shall give Sponsor
prompt written notice so that Sponsor may seek, in its sole discretion, a
protective order or other appropriate remedy. If, in the absence of a protective
order (or other protective remedy), University is nonetheless compelled to
disclose Confidential Information, University may disclose such information
without liability hereunder, provided that University gives written notice to
Sponsor of the Confidential Information to be disclosed as far in advance of its
disclosure as is practicable and, upon Sponsor’s request, University shall use
best efforts to obtain assurances that confidential treatment will be accorded
to such Confidential Information.

 

8.           Indemnification.

 

8.1           Indemnification by University. University is a governmental entity
under the Governmental Immunity Act of Utah, Utah Code §§ 63G -7-101 to 904, as
amended (the “Act”). Nothing in this Agreement shall be construed as a waiver by
University of any protections, rights, or defenses applicable to University
under the Act, including without limitation, the provisions of section 63G-7-604
regarding limitation of judgments.  It is not the intent of University to incur
by contract any liability for the operations, acts, or omissions of the other
party or any third party and nothing in this Agreement shall be so interpreted
or construed.    Without limiting the generality of the foregoing, and
notwithstanding any provisions to the contrary in this Agreement, any indemnity
obligations of University contained in this Agreement are subject to the Act,
are limited to the amounts established in section 63G-7-604 of the Act, and are
further limited only to claims that arise from the negligent acts or omissions
of University. Subject to the Act, University shall indemnify, defend and hold
harmless Sponsor, its directors, officers, agents and employees against any
actions, suits, proceedings, liabilities and damages to the extent caused by the
negligent acts or omissions of University, its officers, agents or employees in
connection with the performance of University’s obligations under this
Agreement.

 

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8.2           Indemnification by Sponsor. Sponsor shall indemnify, defend and
hold harmless University, its directors, officers, agents and employees against
any actions, suits, proceedings, liabilities and damages that may result from
the negligent acts or omissions of Sponsor, its officers, agents or employees in
connection with this Agreement.

 

9.           Compliance With Laws. In performance of the Research, Sponsor and
University shall comply with all applicable federal, state and local laws,
codes, regulations, rules and orders.

 

10.         Patents and Inventions.

 

10.1        Work for Hire.

 

(a)          All intellectual property made, developed or created by University
as a direct result of its performance of its obligations hereunder, including,
without limitation, all inventions, discoveries, patent rights, trade secrets,
information, data, methods, techniques and know-how, including all cell lines,
cell culture media and derivatives thereof (collectively, the “Intellectual
Property”), shall be subject to this Agreement.

 

(b)          All Intellectual Property, other than trade secrets and know-how
(collectively, “Assigned IP”), shall be deemed to be furnished under this
Agreement as a “work for hire” (as such term is defined under United States
copyright laws) and shall become the exclusive property of Sponsor in perpetuity
for all purposes throughout the world. To the extent any Assigned IP does not
qualify as "work for hire" under applicable law, University hereby irrevocably
and exclusively assigns to Sponsor, its successors, and assigns, all right,
title, and interest in and to all such Assigned IP, including any patent
applications naming a University faculty member or employee. To the extent any
of University’s rights in the Assigned IP, including without limitation any
moral rights, are not subject to assignment hereunder, University hereby
irrevocably and unconditionally waives all enforcement of such rights.
University shall execute and deliver such instruments and take such other
actions as may be required to carry out and confirm the assignments contemplated
by this paragraph and the remainder of this Agreement. With respect to all
Assigned IP, including, without limitation, all patentable inventions and
copyrightable works, Sponsor, on behalf of itself, its successors and assigns,
hereby grants to University a perpetual, irrevocable, non-sublicensable,
non-assignable, world-wide, royalty-free, non-exclusive license to practice or
otherwise use Assigned IP for the limited purposes of non-commercial research,
academic and educational purposes.

 

(c)          With respect to all Intellectual Property that is not Assigned IP,
namely all trade secrets and know-how (collectively, “Licensed IP”), University,
on behalf of itself, its successors and assigns, hereby grants to Sponsor a
perpetual, irrevocable, sub-licensable, assignable, world-wide, royalty-free,
non-exclusive license to practice or otherwise use such Licensed IP in all
fields of use.

 

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(d)          University acknowledges that Sponsor shall have the right to use,
exploit, produce, improve, change, and sell the Assigned IP, and otherwise
exploit any or all Intellectual Property in any manner and in any and all media,
whether now known or hereafter devised, throughout the world in perpetuity, as
Sponsor shall determine in its sole discretion provided that no license,
assignment, transfer or other disposition of the Assigned IP will be
inconsistent with the license Sponsor has granted to University hereunder.
University agrees to cooperate with Sponsor in any efforts that Sponsor decides
to undertake to obtain available protection for the Intellectual Property under
United States or foreign laws and University agrees it will execute any
assignments or other documents and do all such other acts or things reasonably
required to effectuate the intent of this paragraph without any additional
compensation.

 

(e)          University acknowledges and agrees that any and all trade secrets
and know-how developed or obtained prior to the date hereof in connection with
the Scope of Work, including in connection with the Patent being obtained by
Sponsor pursuant to that certain Assignment Agreement of even date between
University of Utah Research Foundation and Sponsor, shall be considered Licensed
IP for purposes of paragraph (c) hereof and, accordingly, Sponsor shall have a
perpetual, irrevocable, sub-licensable, assignable, world-wide, royalty-free,
non-exclusive license to practice or otherwise use such trade secrets and
know-how in all fields of use.

 

10.2        Royalty.

 

(a)          In consideration of University’s performance of the Research,
Sponsor shall pay to University, during the twenty (20) year period commencing
on the Effective Date (the “Royalty Term”), an earned royalty of five percent
(5%) of Net Sales (as hereinafter defined) of all products and/or methods to the
extent, and only to the extent, directly arising from inventions and
improvements conceived or reduced to practice by University in the course of
performing the Research during the Term pursuant to this Agreement (“Products
and Methods”). Earned royalties shall be payable to University whether or not a
patent is applied for in a particular country.

 

(b)          For purposes hereof, “Net Sales” shall mean the gross revenue and
other consideration paid or given to Sponsor or its Affiliates for Products
and/or Methods which are sold, leased or otherwise commercialized (collectively,
“Sale’) by or for Sponsor or any of its Affiliates; however, Sales or other
transfers of Products and/or practice of Methods between Sponsor and its
Affiliates shall be excluded from the computation of Net Sales. In addition,
“Net Sales” shall not include any of the following:

 

(i)cash, quantity and other trade discounts, credits or allowances;

 

(ii)credits or allowances granted upon returns, rejections or recalls;

 

(iii)amounts payable resulting from governmental (or any agency thereof)
mandated rebate programs;

 

(iv)chargebacks and other amounts paid on the Sale or dispensing of Products or
Procedures;

 

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(v)taxes, tariffs and duties;

 

(vi)transportation, freight, postage, importation, insurance and other handling
expenses;

 

(vii)delayed ship order credits;

 

(viii)discounts pursuant to indigent patient programs and patient discount
programs and coupon discounts;

 

(ix)amounts received from University or its Affiliates;

 

(x)amounts received as grants from any governmental body, quasi-governmental
body or foundation;

 

(xi)amounts received from third parties in connection with clinical trials; or

 

(xii)Patent Revenue (as such term is defined in that certain Assignment
Agreement of even date between University of Utah Research Foundation
(“Foundation”) and Sponsor), it being understood and agreed that Sponsor will
not be obligated to pay royalties to both University and Foundation with respect
to the same revenue and other consideration.

 

(c)          A Product and/or Method shall be considered sold when it is
shipped, delivered, or invoiced, whichever is earlier. No deductions shall be
made from Net Sales for commissions paid to individuals whether they are with
independent sales agencies or are regularly employed by Sponsor or its
Affiliates and are on its or their payroll, or for the cost of collections. In
the event Sponsor transfers a Product to, and/or transfers or performs a Method
for, a third party in a bona fide arm’s length transaction, for consideration,
in whole or in part, other than cash, then the Net Sales price for such Product
and/or Method shall be deemed to be the standard invoice price then being
invoiced by Sponsor in an arm’s length transaction with similar companies or, in
the absence of such standard invoice price, then the reasonable fair market
value of the Product and/or Method. Components of Net Sales shall be determined
in the ordinary course of business using the accrual method of accounting in
accordance with generally accepted accounting practices.

 

(d)          If Sponsor or any Affiliate Sells any Product and/or Method at a
reduced fee or price for the purpose of promoting other products, goods or
services or for the purpose of facilitating the Sale of other products, goods or
services, then Sponsor shall pay to University, and each such Affiliate shall be
obligated to pay to University, a royalty under Section 10 based upon the fair
market value of the Product and/or Method.

 

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11.         Relationship of Parties. In assuming and performing the obligations
of this Agreement, University and Sponsor are each acting as independent parties
and neither shall be considered or represent itself as a joint venturer,
partner, agent or employee of the other. Neither party shall use the name or any
trademark of the other party in any advertising, sales promotion or other
publicity matter without the prior written approval of the other party.

 

12.         Termination.

 

12.1        Termination Right. This Agreement may be terminated as follows:

 

(a)          by either party, by giving written notice to the other party, in
the event of a material breach of this Agreement by the other party and the
continuance thereof for a period of thirty (30) days following receipt of
written notice thereof;

 

(b)          by Sponsor, by giving written notice to University, in the event
that Dr. Amit Patel is no longer employed by University; and

 

(c)          by Sponsor after the second anniversary of the Effective Date, by
giving written notice to University, in the event that, based upon the Research
performed, Sponsor reasonably believes that it cannot in good faith file an IND
application with the FDA for a Phase I safety and feasibility study or that, if
filed, the IND application would not be approved by the FDA.

 

12.2         Effect of Termination. Termination of this Agreement shall not
relieve either party of any obligation or liability accrued hereunder prior to
such termination with regard to obligations due prior to such termination, or
rescind or give rise to any right to rescind any payments made prior to the time
of such termination.

 

13.         Exclusivity. During the Term, no University laboratory that operates
under the supervision of Dr. Amit Patel shall perform or provide research or
other services relating to brown fat other than for the benefit of Sponsor;
provided, however, that the foregoing shall not restrict the performance of
research solely for academic purposes in accordance with the provisions of this
Agreement..

 

14.         Insurance. During the Term, University will carry and maintain in
full force and effect at all times either with financially sound and reputable
insurers, or pursuant to a program of self-insurance, liability insurance
against claims for personal injury or death. Such insurance shall be maintained
in such form and in such amounts as are consistent with University’s current
practice.

 

15.         Uncontrollable Forces. Neither Sponsor nor University shall be
considered to be in default of this Agreement if delays in or failure of
performance shall be due to uncontrollable forces the effect of which, by the
exercise of reasonable diligence, the nonperforming party could not avoid. The
term “uncontrollable forces” shall mean any event which results in the
prevention or delay of performance by a party of its obligations under this
Agreement and which is beyond the control of the nonperforming party. It
includes, but is not limited to, fire, flood, earthquakes, storms, lightning,
epidemic, war, riot, civil disturbance, sabotage, inability to procure permits,
licenses, or authorizations from any state, local, or federal agency or person
for any of the supplies, materials, accesses, or services required to be
provided by either Sponsor or University under this Agreement, strikes, work
slowdowns or other labor disturbances, and judicial restraint.

 

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16.         Miscellaneous.

 

16.1        Assignment. Neither this Agreement nor any of the rights or
obligations hereunder may be assigned by University without the prior written
consent of Sponsor. Sponsor may assign any and all of its rights and obligations
under this Agreement.

 

16.2        Entire Agreement. This Agreement, with its attachments, constitutes
the entire agreement between the parties regarding the subject matter hereof and
supersedes any other written or oral understanding of the parties. This
Agreement may not be modified except by a written instrument executed by both
parties.

 

16.3        Successors and Assigns. This Agreement shall be binding upon and
inure to the benefit of the parties and their respective successors and
permitted assigns.

 

16.4        Publicity. Subject to the provisions of Section 7.2(b) hereof,
neither party shall have the right to make any public announcements or other
disclosures with respect to this Agreement, nor disclose the terms of this
Agreement, without the prior written consent of the other party, except as
follows:

 

(a)          Upon Sponsor’s request, the parties shall exercise good faith
efforts to reach agreement on the text of a press release regarding this
Agreement.

 

(b)          Each party may disclose the terms of this Agreement to the extent
such disclosure is required by law (including without limitation by rules or
regulations of the Securities and Exchange Commission, any securities exchange
or NASDAQ) or to defend or prosecute litigation or arbitration; provided, that,
prior to such disclosure, to the extent permitted by law or such rules or
regulations, the disclosing party promptly notifies the other party of such
requirement and the disclosing party furnishes only those terms of this
Agreement that the disclosing party is legally required to furnish.

 

(c)          Sponsor may disclose this Agreement to (i) Sponsor’s then-current
and potential third party licensees and sublicensees, and (ii) Sponsor’s
then-current and potential directors, investors, lenders and acquirers;
provided, that such persons are bound to maintain the confidentiality of this
Agreement to the same extent as if they were parties hereto.

 

16.5        Notices. Except as provided in Section 3 hereof regarding payment of
invoices, any notice or other communication required or permitted to be given to
either party hereto shall be in writing and shall be deemed to have been
properly given and effective: (a) on the date of delivery if delivered in person
during recipient’s normal business hours; or (b) on the date of delivery if
delivered by courier, express mail service or first-class mail, registered or
certified, return receipt requested. Such notice shall be sent or delivered to
the respective addresses given below, or to such other address as either party
shall designate by written notice given to the other party as follows:

 

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In the case of University:

 

Technical   Contractual       Dr. Amit Patel, MD, MS   University of Utah
University of Utah   Office of Sponsored Projects 30 North 1900 East 3C127  
1471 East Federal Way Salt Lake City, Utah 84132   Salt Lake City, Utah 
84102-1821

 

In the case of Sponsor:

 

Technical   Contractual       555 Heritage Drive   555 Heritage Drive Suite 130
  Suite 130 Jupiter, Florida 33458   Jupiter, Florida 33458 Attn: Research
Scientist   Attn:  Chief Executive Officer

 

 

16.6        Order of Precedence. In the event of any conflict, inconsistency or
discrepancy amount, this Agreement and any other documents listed below shall be
resolved by giving precedence in the following order:

 

(a)       This Agreement including the annexes hereto; and

 

(b)       Purchase orders issued by Sponsor. In the event a purchase order is
issued under this Agreement and such purchase order contains standardized terms
and conditions, the terms and conditions of this Agreement shall supercede and
replace all such purchase order standardized terms and conditions.

 

16.7        Governing Law. This Agreement shall be interpreted and construed in
accordance with the laws of the State of Utah, without application of any
principles of choice of laws.

 

16.8        Nonwaiver. A waiver by either party of any breach of this Agreement
shall not be binding upon the waiving party unless such waiver is in writing. In
the event of a written waiver, such a waiver shall not affect the waiving
party’s rights with respect to any other or further breach.

 

16.9        Counterparts; Facsimile or Email Signatures. This Agreement may be
executed in any number of counterparts, each of which shall be deemed an
original, and all of which together shall constitute one and the same
instrument. Signatures hereon which are transmitted via facsimile or email shall
be deemed original signatures.

 

[Remainder of page intentionally left blank. Signature page follows.]

 

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives effective as of the day and year first
written above.

 

BIORESTORATIVE THERAPIES, INC.   UNIVERSITY OF UTAH “Sponsor”   “University”    
  By: /s/ Mark Weinreb   By: /s/ Kristee Thompson (for Todd Nilsen) Name: Mark
Weinreb   Name: Todd Nilsen Title: Chief Executive Officer   Title: Associate
Director,         Office of Sponsored Projects Date: June 8, 2012   Date: June
__, 2012

 

 

 

 

APPENDIX A

SCOPE OF WORK

 

The research and development that will be performed at University under the
supervision of Dr. Amit Patel will involve the following milestones and will be
developed using methods and materials that will be able to be clinically
translated. Data generated and collected will be used for the filing of an IND
with the FDA for a Phase 1 clinical trial.

 

Brown Adipose Identification

 

Human adipose tissue depots will be procured under approved University IRB
protocols. These tissues will be identified to contain brown adipose populations
by morphological, immunohistochemical and gene expression profiles that are
specific to brown adipose. In addition, whenever possible, identification of
brown adipose depots will include PET imaging.

 

Cell-Line Expansion and Characterization

 

Cell-lines will be developed and characterized from these brown adipose depots.
Characterization of these cell-lines will include growth kinetics, gene
expression profile, micro-RNA profile, cell surface marker profile, metabolic
activity and differentiation potential (i.e., osteogenesis, chondrogenesis,
white and brown adipogenesis). Differentiation will be confirmed by
immunocytochemistry, protein expression, gene expression profile and functional
assays (i.e., metabolic activity)

 

Once a brown fat line has been identified, different cell-lines will be
generated containing several different constructs with brown fat specific genes
(i.e., PRDM16, UCP1,) with down stream reporter genes. These cell-lines will be
used for small molecule screening.

 

Cells will also be cultured on biodegradable scaffolds and induced to
differentiate within the scaffold. Metabolic activity of the cellular/scaffold
matrix will be determined.

 

Pre-Clinical Animal Models

 

After a clinical cell-line with metabolic activity has been identified and
characterized, pre-clinical small animal models will be initiated. These animal
models will be used to determine the feasibility of using a cell-based approach
to treat human metabolic disorders. In addition, if a small molecule has been
identified, safety and feasibility testing will be performed.

 

IND Filing with the FDA for a Phase 1 Clinical Trial

 

After pre-clinical testing in small animal models, data will be collected and
submitted for an IND filing with the FDA for a Phase 1 safety and feasibility
study. If IND approval is obtained, clinical grade product will be manufactured
at University cGMP facility.

 

 

 

 

APPENDIX B

RESEARCH AGREEMENT BUDGET

 

   Direct Expenses   Indirect (32.5%)   Fee to TCO (2%)   TOTAL  Year 1 
$371,747   $120,818   $7,435   $500,000  Year 2  $371,747   $120,818   $7,435  
$500,000  Year 3  $371,747   $120,818   $7,435   $500,000  TOTAL  $1,115,241  
$362,454   $22,305   $1,500,000