[Pursuant to 17 C.F.R. 240.24b-2, confidential information has been omitted in
places marked “[…***…]” and has been filed separately with the Securities and
Exchange Commission pursuant to a Confidential Treatment Application.]

 

RESEARCH AGREEMENT

 

(“Agreement”)

 

Pfizer Inc, a Delaware corporation with an address at 235 East 42nd Street, New
York, New York 10017 (“PFIZER”), and BioRestorative Therapies, Inc., a Nevada
corporation with an address at 555 Heritage Drive, Jupiter, Florida 33458
(“BRT”), enter into this Agreement for the conduct of studies entitled
“Development and Validation of a Human Brown Adipose Cell Model” as set forth in
the research plan attached as Exhibit A (“Research Plan”).

 

1.DEFINITION:

 

1.1.“Affiliate” means any corporation, firm, partnership or other entity which
directly or indirectly controls, is controlled by, or is under common control
with a particular party.

1.2.“Applicable Law” means any statute, law, treaty, rule, code, ordinance,
regulation, permit, interpretation, certificate or order of a Governmental
Authority, or any judgment, decision, decree, injunction, writ, order, subpoena,
or like action of any court, arbitrator or other government entity related to
the collection, retention, security and use of the Material, as the same are
promulgated and applied as of the effective date of this Agreement and at all
times thereafter.

1.3.“BRT Material” means all materials or samples (including, without
limitation, […***…]) provided by or on behalf of or otherwise made available by
or on behalf of BRT to PFIZER pursuant to or otherwise in connection with this
Agreement.

1.4.“BRT Results” means and includes all technology, materials, intellectual
property and technical information that are developed by BRT employees,
technicians or others working solely on behalf of BRT (excluding any PFIZER
employees or contractors) in performance of the Research Plan.

1.5.“Donor” means the donor of the Donor Material or of the original tissues
from which the Donor Material was derived.

1.6.“Donor Material” means cells, cell cultures, blood, fluids, tissues, genetic
information (including data or results derived from human brown and white
adipose cell lines).

1.7.“Governmental Authority” means any federal, state, local or foreign
government entity, authority, agency, instrumentality, court, tribunal,
regulatory commission or other body, whether legislative, judicial,
administrative or executive (or a combination or permutation thereof), and any
arbitrator to whom a dispute has been presented under government rule or by
agreement of the parties with an interest in such dispute.

1.8.“HIPAA” means the Health Insurance Portability and Accountability Act of
1996, as codified at 42 USC § 1320(d) and all regulations promulgated
thereunder.

  

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

  

 

 

  

1.9.“Patient Identifiable Information” means any information (whether or not key
coded) that identifies, or could identify, the Donor and/or any individually
identifiable, or potentially individually identifiable, health information of
that Donor, including, without limitation, Protected Health Information (as
defined in 45 CFR § 164.501) or Individually Identifiable Health Information (as
defined in 42 USC § 1320(d)) and other information protected by data protection
and/or privacy legislation in any and all applicable territories.

1.10."PFIZER Material" means all materials or samples (including, without
limitation, […***…]) provided by or on behalf of or otherwise made available by
or on behalf of PFIZER to BRT pursuant to or otherwise in connection with this
Agreement.

1.11.“PFIZER Results” means and includes all technology, materials, intellectual
property and technical information that are developed by PFIZER employees,
technicians or others working solely on behalf of PFIZER (excluding any BRT
employees or contractors) in performance of the Research Plan.

1.12.“Privacy Board” means a review body that is established to act upon
requests for a waiver or an alteration of the authorization requirement under
the privacy rule for uses and disclosures of Patient Identifiable Information
for the relevant research study.

 

2.SCOPE OF WORK: BRT, under the direction of principal investigator, Francisco
Silva, Vice President, Research & Development (“Principal Investigator”), will
perform the studies and provide to PFIZER the data and reports described in the
Research Plan.

 

3.TERM: The term of this Agreement is effective as of March 24th, 2014
(“Effective Date”) and unless earlier terminated or extended, continues for two
(2) years until March 23rd ,2016 (the “Expiration Date”), or until the
completion of the work described in the Research Plan, whichever comes first.

 

4.PAYMENT: PFIZER will pay BRT up to the sum of $775,000 (Seven Hundred and
Seventy Five Thousand Dollars) during the term of this Agreement according to
the following payment schedule:

 

·The sum of $250,000 (Two Hundred Fifty Thousand Dollars) (the “Initial
Payment”) – which represents technology access fee, upfront costs, and Q1 labor
costs associated with Workstream #1 — will be payable concurrently with the
execution of this Agreement.

·The sum of $356,250 (Three Hundred Fifty-Six Thousand Two Hundred Fifty
Dollars) (the “Second Installment”) will be payable in four (4) equal quarterly
installments (of $89,062.50 for Q2, Q3, Q4, and Q5) commencing on the three (3)
month anniversary of the Effective Date and continuing every three (3) months
thereafter (each, a “Quarterly Period”); provided, however, that, in the event
of the achievement of Workstream #1 Deliverable #1 — Delivery from BRT to PFE of
[…***…], the balance of the Second Installment shall be due and payable.

·The sum of $168,750 (One Hundred Sixty-Eight Thousand Seven Hundred Fifty
Dollars) (the “Third Installment”) will be payable in two (2) equal bi-annual
installments (of $84,375) following the Second Installment and continuing every
six (6) months thereafter (each, a “Bi-Annual Period”); provided, however, that,
in the event of achievement of Workstream #2 Deliverable #2 — analysis of
[…***…] and delivery of the final report to PFIZER, the balance of the Third
Installment shall be due and payable.

  

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

 

 

 

 

  

Payments under this Agreement will be due within thirty (30) days following
PFIZER’s receipt of an invoice from BRT (except that the Initial Payment shall
be paid concurrently with the execution of this Agreement).

 

All invoices shall be delivered to PFIZER c/o: PFIZER INC. GFSS – AMERICAS, PO
Box 34600, Bartlett, TN 38184-0600, United States. To receive payment from your
purchase order (PO), mail a document clearly marked 'INVOICE' to the address
above (or email apinvoices@pfizer.com) with the following information clearly
listed: Description of research conducted, and/or goods provided, PO number,
amount owed and name and address payment is to be sent to. This will help
facilitate a quick payment to BRT for research conducted. BRTs enrolled in
PFIZER's e-Invoicing programs (ASN or OB10) can ignore this PO Note. All invoice
or billing related questions should be referred to PFIZER's Accounting
Department at 800.601.1357 or go to the Accounts Payable Inquiry Tool (APIQ) at
www.pfizeraccountspayable.com.

 

In addition, a copy of each invoice will be mailed and emailed to:

 

Michael Rukstalis, Principal Scientist

 

CVMED Research Unit

 

Pfizer Worldwide Research & Development

 

Cambridge Laboratories

 

610 Main St

 

Cambridge, MA 02139

 

with an electronic copy to:

 

Michael Rukstalis at: michael.rukstalis@pfizer.com

  

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

  

 

 

  

5.PFIZER & BRT MATERIAL:

5.1.1.Ownership, Delivery and Handling. BRT acknowledges and agrees that, as
between the parties, PFIZER is and shall at all times remain the sole and
exclusive owner of the PFIZER Material and all intellectual property rights
therein. PFIZER acknowledges and agrees that, as between the parties, BRT is and
shall at all times remain the sole and exclusive owner of the BRT Material and
all intellectual property rights therein. PFIZER will supply BRT with such
quantities and types of the PFIZER Material as PFIZER in its sole discretion
determines is appropriate under the Research Plan, and BRT will supply PFIZER
with such quantities and types of the BRT Material as BRT in its sole discretion
determines is appropriate under the Research Plan. Upon the sooner of the
expiration or termination of this Agreement or upon the request of PFIZER, BRT
shall, in accordance with PFIZER’s instructions, return to PFIZER, or destroy at
PFIZER’s option with written certification of such destruction sent to PFIZER,
all unused PFIZER Material. Upon the sooner of the expiration or termination of
this Agreement or upon the request of BRT, PFIZER shall, in accordance with BRT’
instructions, destroy with written certification of such destruction sent to
BRT, all stem cell lines in PFIZER’s possession that were developed by BRT
during the performance of the Research Plan and were not selected by PFIZER
pursuant to the Workstream 1 Deliverables set forth in the Research Plan for
further analysis in Workstream 2.

 

5.1.2.Experimental Materials. BRT acknowledges that the PFIZER Material
comprises experimental materials and BRT will comply with all laws and
regulations applicable to handling and use of such materials. BRT will not use
the PFIZER Material for testing in or treatment of human subjects. PFIZER
acknowledges that the BRT Material comprises experimental materials and PFIZER
will comply with all laws and regulations applicable to handling and use of such
materials. PFIZER will not use the BRT Material for testing in or treatment of
human subjects.

 

5.1.3.NO WARRANTY. THE PFIZER MATERIAL AND BRT MATERIAL ARE PROVIDED TO THE
OTHER PARTY AS-IS AND WITHOUT WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, TITLE, OR FITNESS FOR A PARTICULAR
PURPOSE.

 

5.1.4.Transfer of Material. BRT will not transfer, disclose, make available, or
sell any of the PFIZER Material to any third party. BRT shall not modify or use
the PFIZER Material other than as expressly permitted under the Research Plan.
PFIZER will not transfer, disclose, make available, or sell any of the BRT
Material to any third party except as permitted under Section 6(a).

 

5.1.5.Use of Material. BRT will use the PFIZER Material solely for the purpose
of performing the Research Plan. BRT shall not analyze the PFIZER Material or
attempt in any way to discover the identity, structure, mechanism of action, or
composition of the PFIZER Material other than as expressly permitted under the
Research Plan. Notwithstanding any provision in this Agreement to the contrary,
PFIZER shall not be obligated at any time to disclose to BRT the identity,
structure, composition of, or other information concerning, the PFIZER Material.

 

6.INTELLECTUAL PROPERTY:

 

(a) BRT Materials; BRT Results. […***…]

 

(b)           PFIZER Related IP. […***…]

  

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

  

 

 

  

(c)  PFIZER Materials; PFIZER Results. […***…]

 

(d)  […***…]

 

7.INFORMATION: For purposes of this Agreement, the term “Information” means all
written information relating to the studies described in the Research Plan,
including but not limited to data, know-how, materials, compound samples and
compound specifications which PFIZER shall deliver to BRT, or BRT shall deliver
to PFIZER, pursuant to this Agreement, stamped “Confidential,” or disclosed to
BRT or PFIZER, as the case may be, orally declaring same to be confidential and
confirming such declaration in writing within thirty (30) days of disclosure.

 

8.CONFIDENTIALITY: Each party agrees to maintain the Information in confidence
with the same degree of care it holds its own confidential information. Neither
party will use the Information except for the studies described in the Research
Plan or as otherwise permitted herein to practice the rights granted herein.
Each party will disclose the Information only to its officers, directors,
employees and consultants directly concerned with the studies, but will neither
disclose information to any third party nor use the Information for any other
purpose.

 

9.EXCEPTIONS TO CONFIDENTIALITY: Each party’s obligation of nondisclosure and
the limitations upon the right to use the Information shall not apply to the
extent that such party can demonstrate that the Information: (a) was in the
possession of such party prior to the time of disclosure; or (b) is or becomes
public knowledge through no fault or omission of such party; or (c) is obtained
by such party from a third party under no obligation of confidentiality to the
other party.

 

In the event a party is legally required to disclose any of the Information,
such party shall provide prompt prior written notice of such requirement to the
other party, afford the other party an opportunity to secure confidential
treatment for such disclosure, and if the other party is unsuccessful, furnish
only that portion of the Information which such party is legally required to
disclose.

 

10.SURVIVAL OF CONFIDENTIALITY OBLIGATIONS: All obligations relating to
confidentiality of the parties under this Agreement shall survive the
termination of this Agreement for a period of […***…].

 

11.DONOR MATERIAL: BRT represents that the Donor Material used in, provided to
PFIZER, pursuant to this Agreement will conform to the overall description,
features, function and specifications set forth in the Research Plan.
Furthermore, BRT represents and warrants the following:

11.1.            BRT will not provide to PFIZER any medical information or
Patient Identifiable Information about any Donor.

11.2.            BRT will comply with all Applicable Laws and obtain all
required governmental permits, licenses and authorizations in the collection and
handling of the Donor Material.

11.3.            Collection of the Donor Material has been approved by an
Institutional Review Board (“IRB”) that complies with all Applicable Laws for
such a body.

11.4.            An IRB-approved informed consent form (“ICF”) compliant with
all Applicable Laws, will be signed by and obtained from each Donor (or Donor’s
representative in the event that the Donor is incapacitated) prior to donation
in respect of each Donor Material (or the tissue from which the Material was
derived) (“Informed Consent”).

  

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

  

 

 

  

11.5.            BRT has legal right and title to the Donor Material and has the
required Donor consent to transfer the Donor Material to PFIZER.

11.6.            Uses of the Donor Material described in the Research Plan are
within the scope of and consistent with BRT’s ethical approval policies, if any,
the Informed Consent, and the IRB’s approval.

 

12.REPORTS: BRT shall cause the Principal Investigator to furnish to PFIZER a
comprehensive report within thirty (30) days of the one year anniversary of the
Effective Date, describing in reasonable detail the work accomplished on the
studies described in the Research Plan.

 

13.DISCLOSURE OF FEES: As part of any disclosure policy that may be implemented
from time-to-time by a party regarding payments made to members of the medical
or scientific community, or in accordance with applicable laws or regulations,
such party shall have the right to disclose any terms related to this Agreement,
including the Principal Investigator’s name and the fees provided to BRT
hereunder.

 

14.HANDLING OF PATIENT INFORMATION:

14.1.             BRT and PFIZER will each comply in all material respects with
all Applicable Law regarding the privacy of Patient Identifiable Information
(including during collection, use, storage, and disclosure), including, but not
limited to, HIPAA and any current and future regulations promulgated thereunder
including without limitation the federal privacy regulations contained in 45 CFR
Parts 160 and 164, the federal security standards contained in 45 CFR Parts 106
and 162, all collectively referred to herein as “HIPAA Requirements”).

14.2.             BRT agrees to collect, use, store, and disclose Patient
Identifiable Information collected or provided as part of the Research Plan and
for the purpose of complying with applicable law, provided that all such uses
are disclosed in the ICF.

14.3.             BRT will ensure that that ICF provides PFIZER may use the
Donor Material for any research, development and regulatory purpose.

14.4.             BRT agrees that it will not disclose to PFIZER any Patient
Identifiable Information of any Donor and PFIZER will not attempt to identify
any Donor.

14.5.             If PFIZER inadvertently receives Patient Identifiable
Information from BRT, PFIZER will take appropriate measures to protect the
privacy and confidentiality of such information and to ensure that PFIZER’s
collaborators take similar measures.

 

15.ENTIRE AGREEMENT: This Agreement sets forth the entire agreement between
PFIZER and BRT as to its subject matter. None of the terms of this Agreement
shall be amended except in writing signed by both parties.

 

16.BREACH AND TERMINATION: If either party breaches this Agreement in any
material respect, the other party may terminate it if the breaching party does
not cure the breach within thirty (30) days of written notice of the same (a
“Breach Termination”). PFIZER may terminate this Agreement […***…] by giving
thirty (30) days notice to BRT in writing. […***…] The right of termination
shall be an addition to any other rights the terminating party may have, at law
or equity, pursuant to this Agreement. Sections 1, 5, 6, 8, 9, 10, 15 and 18
shall survive any termination of this Agreement, whether due to a breach or
otherwise.

  

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

  

 

 

  

17.COMPLIANCE WITH LAWS: Both PFIZER and BRT shall comply in all material
respects with the requirements of all Applicable Laws, rules, regulations and
orders of any government authority including laws related to animal welfare. BRT
will comply with Pfizer’s animal care and use policy —
http://www.pfizer.com/research/research_clinical_trials/laboratory_animal_care .
BRT will procure all Donor Material in accordance with all Applicable Laws.
Additionally, PFIZER agrees to use the Donor Material in compliance with all
Applicable Laws. BRT shall not use services of any BRT employees that have been
or are currently debarred or otherwise disqualified by the United States Food
and Drug Administration or other regulatory or certification authority.

 

17.1.             Regulatory. BRT is solely responsible for any and all safety
reporting and regulatory obligations associated with the procurement of the
Donor Material.

17.2.             Standards. BRT will procure the Donor Material in accordance
with International Conference on Harmonization Good Clinical Practice (“ICH
GCP”) guidelines (to the extent applicable), and all Applicable Laws. BRT will
comply with all IRB requirements relating to the procurement of Donor Materials.

17.3.             IRB Approval. If required, BRT will ensure that the
procurement of the Donor Material is approved by and subject to continuing
oversight by an appropriate IRB.

17.4.             Informed Consent. As required, BRT will obtain Informed
Consent from each Donor in accordance with Applicable Law (including without
limitation 21 Code of Federal Regulations Part 50), ensure that Informed Consent
that covers the research to be conducted has already been obtained, or obtain a
waiver of Informed Consent for procurement of the Donor Material from an
appropriate IRB. If an Informed Consent is used, BRT will inform Donors that
Pfizer is providing support for procurement of the Donor Material. Pfizer has no
obligation to participate in the development of, or to review or comment on, an
ICF, authorization, or waiver request.

 

18.CHOICE OF LAW: This Agreement shall be construed in accordance with the laws
of the State of New York, excluding choice of law principles thereof.

 

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

 

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

 

 

 

  

IN WITNESS WHEREOF, duly-authorized representatives of the parties have signed
as of the dates written below.

 

BioRestorative Therapies, Inc.     Pfizer Inc.  

 

 

By:     By:  

 

 

Print Name:     Print Name:  

 

 

Title:     Title:               (Duly authorized)     (Duly authorized)

 

[…***…] Confidential information has been omitted and filed separately with the
Securities and Exchange Commission. Confidential treatment has been requested
with respect to this omitted information.

 

 

 

  

EXHIBIT A

 

RESEARCH PLAN

 

[…***…]