EXHIBIT 10.21

 

RESEARCH AGREEMENT

 

This Research Agreement (“Agreement”) is made and entered into this 29th day of
December, 2016, by and between One World Cannabis Ltd., a company duly
incorporated under the laws of the State of Israel, having its registered office
at 7 Imber Street, Petach Tikva, 4951141, Israel, by its authorized
representative, Mr. Ziv Turner, CEO (the “Company”)

 

and:

 

Medical Research Infrastructure Development and Health Services Fund by Chaim
Sheba Medical Center, a non-profit organization incorporated under the laws of
the State of Israel, represented by ________________, its authorized
representative (the “Fund”);

 

Each of the parties above may be referred to as “Party” or collectively, as the
“Parties.”

 

Whereas: The Company wishes that the Fund, employing the services of Dr. Aviv
Barzilay (the “Investigator”) carry out the Study, as defined below, in
accordance with the terms of this Agreement and the Protocol, as defined below;
and     Whereas: The Fund agrees to carry-out the Study, employing the services
of the Investigator; and     Whereas: The Parties to this Agreement agree to
comply with the terms specified in the Ministry Guidelines, as defined below,
including without limitation Fonn 4A (to the Guidelines and other applicable
Israeli laws, rules and regulations; AND Whereas  the Parties have executed a
master Quality Agreement required pursuant to the MOH Guidelines: GMP (Good
Manufacturing Practices) for MPs (Investigational Medicinal Products) No.
EX-012/01 effective as of 29.12.2016 which constitute an integral part of this
Agreement.

 

NOW, THEREFOR, the Parties agree, declare and stipulate as follows:

 

1.THE PREAMBLE AND DEFINITIONS:

 

  1.1.The Preamble to this Research Agreement and all its addenda constitute an
integral part thereof. The terms specified in the Preamble, which are defined
hereinafter, shall be interpreted according to the meaning ascribed to them
hereinafter.        1.2.In addition to terms defined elsewhere in this Agreement
or its appendices, the following terms shall have the meaning ascribed to them
hereinafter:         The “Study”: the clinical trial detailed in the Protocol.

 

The “Protocol”: The Study plan prepared by the Company numbered
3322-16-SMC\OWC-PS0-01, titled “A Phase I, double blind, randomized, placebo
controlled, maximal dose study to determine the safety, tolerability of Topical
cream containing MGC (Medical Grade Cannabis) in healthy volunteers” attached to
this Agreement as Schedule A and constituting an integral part thereof.

 

  The “Hospital”: Chaim Sheba Medical Center.         The “Study Staff”; The
personal designated by the Fund for the     performance of the Study.        
The “Study Drug”: Cannabis.         The “Subject”: A person who is eligible and
who has consented to     participate in the Study.         “MOH”: The Israeli
Ministry of Health.         “Ministry Guidelines: The MOH Guidelines titled
“Clinical Trials of Human         Human Subjects” issued on February 2016, as
may         be amended from time to time or superseded by successor        
Successor laws, rules, regulations or guidelines.

 

 

 

 

  “Form 4A”: Form 4A to the Ministry Guidelines titled “Warrants of the
Sponsor”, attached to this Agreement as Schedule B and constituting an integral
part thereof.         “ICH-GCP”: IICH Harmonized Tripartite Guideline for Good
Clinical Practice 135/95, dated 17 July 1996.         “Helsinki Declaration”:
World Medical Association Declaration of Helsinki regarding “Ethical Principles
for Medical Research Involving Human Subjects” as amended and modified from time
to time.

 

2. PRE-CONDITION:       It is a condition precedent to the validity of this
Research Agreement that this Agreement shall come into effect only after
approval is received from (i) the Helsinki Committee; and (ii) the Hospital’s
Committee for Research Contracts with Commercial Companies. The performance of
the Study shall commence only after both committees have approved the Study.    
3. THE STUDY:

 

  3.1. Compliance. The Fund undertakes to perform the Study, employing the
services of the Investigator, in compliance with the following: (1) the
Protocol; (2) the Ministry Guidelines; (3) the instructions and terms specified
in the Helsinki Committee’s approval; (4) the ICH-GCP; (5) the Helsinki
Declarations; (6) the applicable laws, rules and regulations regulating such
studies which are applicable in Israel; and (7) written instructions and
prescriptions issued by the Company and governing the administration of the
Study Drug (collectively, the “Applicable Laws”). The Fund shall ensure
compliance of the Investigator, Study Staff and other personnel involved in the
performance of the Study on behalf of Fund with all Applicable Laws and the
provisions of this Agreement.           Should any contradiction arise between
the Ministry Guidelines, the Protocol or this Agreement, the Ministry Guidelines
shall prevail.         3.2. Conduct. The Study will be conducted in a manner
required of a reasonable and prudent clinical investigator or physician.        
3.3 Supply of Study Drug. The Company shall provide the Fund, at its sole
expense, with the Study Drug and Placebo (when applicable) required for the
performance of the Study. The Fund shall maintain proper records concerning the
administration of the Study Drug.

 

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  3.4. Investigator. It is agreed by the Parties that the Company is entering
into this Agreement based upon the Fund’s representation that Dr. Barzilay shall
serve as the Investigator and will be responsible for the direction of the Study
in accordance with the Protocol, applicable Fund policies, generally accepted
standards of good clinic practice and all Applicable Laws and regulations. All
obligations of the Investigator hereunder shall be performed solely by or under
the direct supervision of the Investigator. In the event the Investigator, for
any reason whatsoever, is unable to conduct the Study, or shall cease to be
available for the performance of the undertakings set forth in this Agreement,
the Fund shall use its best efforts to appoint, ·within 20 (twenty) days, a
successor investigator whose identity shall be approved in advance by the
Company (the “Successor Investigator”). Should the Fund is unable to appoint
such Successor Investigator, the Company shall have the sole discretion to
terminate the Agreement with prior notice. In the event of such early
termination, the Company shall pay the Fund the agreed Remuneration (as
specified in clause 9) solely for Milestones which were fully achieved by the
Fund prior to such early termination. For the purpose of this Section 3.4,
“Milestones”, as detailed in the Protocol.         3.5. No warranty of results.
For the removal of doubt, it is hereby clarified that nothing specified in this
Agreement shall be construed as a warranty by the Fund that the Study’s results
shall be useful in any manner or commercially exploitable.         3.6. Informed
Consent Form (“ICF”). The Fund shall ensure that each and all of the Subjects
have given their written informed consent to participate in the Study, prior to
their participation. The Fund acknowledges and represents that the ICF includes
and gives effect to all of the elements listed in the Protocol and, in the
reasonable opinion of the Fund, any other information which should be disclosed
therein. The Fund will neither request consent for any Subject, nor allow any
Subject to participate in the Study, prior to receiving all the necessary
approvals detailed in Section 2 above.         3.7. Debarment. The Fund
represents and warrants that, to the best of its knowledge, neither it, nor any
of the Study Staff, including the Investigator, has been debarred, disqualified
or banned from conducting clinical studies.         3.8. Storage of the Study
Drug. The Fund shall store the Study Drug in the Hospital’s Pharmacy according
to the Pharmacy’s practice and policies and in accordance to the Company’s
licenses to use cannabis for medical research, issued by MOH - Israel Medical
Cannabis Unit (IMCU).         3.9. NIH Registration. The Company declares and
covenants that it had registered the Study in the repository of the National
Institute of Health (“NIH”) including registration of the Fund and the Hospital
as one of the sites performing the Study. The confim1ation regarding
registration of the Study in the repository of the NIH, as aforesaid, is
attached as Schedule C to this Agreement and constituting an integral part
thereof.         3.1 0.  Biological Samples. “Biological Samples” means blood,
fluid and/or tissue samples and tangible materials directly or indirectly
derived from such san1ples, collected from Subjects as may be set forth in the
Protocol and as permitted by the Informed Consent Form (“ICF”). The Fund, the
Investigator and the Study Staff will collect, retain and/or use and/or transfer
Biological Samples solely as set forth in Applicable Laws, the Protocol, the ICF
and as approved by the Hospital’s Helsinki Committee. Biological Samples
collected for analyses and therapeutic purposes shall be used solely for that
purpose. Biological Samples will be collected for use in future research only if
it was specified in the Protocol, the ICF and approved by the ethic committee.
To the extent applicable, the Fund shall retain a portion of the Biological
Samples for future research performed by the Fund provided such is approved by
the Hospital’s Helsinki Committee. The Company shall pay for any required
procedures and/or collection and/or transfer of such Biological San1ples by the
Fund and the Investigator. Such payment will be as agreed in advance and in
writing by the Parties.

 

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4. ADVERSE EVENT:

 

  4.1. In the event that one or more of the Subjects sustain any adverse event
related to the Study, the Investigator shall inform the Company and/or the
Hospital’s Helsinki Committee and/or the Hospital’s management and/or the
authorized national health authorities, immediately upon occurrence of such
adverse event. The Investigator and the Fund are also entitled to immediately
cease the performance of the Study and report their decision to the Company.    
    4.2. In the event that one or more of the Subjects sustain any serious
adverse event, the Company undertakes, to the request of the Investigator, to
break the study medication’s code and immediately inform the Investigator and/or
the Fund the content of the medication received by each Subject. The Company
will also immediately take all measures at its disposal, to evaluate the risk to
the other patients and will instruct the Investigator which measures to take
with regard to such risk.

 

5. CONFIDENTIALITY:

 

  5.1. All information disclosed by the Company and obtained by the Fund and/or
its assistants from the Company in connection with the Study (“Confidential
Information”) shall be treated as confidential both during the Study and for a
period of five (5) years following its termination. The Confidential Information
shall not be disclosed to any third party without prior written approval of the
Company, except if requested by law and/or court order and/or the FDA and/or any
national regulatory authority. This restriction shall not apply to Confidential
Information which (i) is, or becomes public domain through no act or omission of
the Fund and/or (ii) was lawfully obtained by the Fund and/or by the
Investigator from another source (iii) was already known to the Fund, other than
under an obligation of confidentiality, at the time of disclosure by the
Company, as evidenced in written records; (iv) was independently discovered or
developed by the Fund without the use of Confidential Information of the
Company.         5.2. The Parties and the Investigator undertake to maintain the
confidentiality of all details relating to the Subjects participating in the
Study. It is hereby agreed that the Fwrd, the Investigator and the Study Staff
shall not release any details of the identity of the Subjects and the Company
undertakes that if, for any reason whatsoever, it should become privy to such
details, it shall maintain them in strict confidentiality. The Fund agrees to
limit its internal disclosure of Confidential Information only to those of its
employees who need to know such information and who are binding to the terms and
conditions included in this Agreement. The Parties shall not disclose any
Confidential Information to any third party without the prior written approval
of the other party.

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6. REPORTS AND PUBLICATIONS:

 

  6.1. The Fund and the Investigator shall promptly and fully disclose to
Company in writing all improvements, developments, discoveries and inventions,
whether or not patentable, conceived or reduced to practice, either alone or
with others, in performance of the Study or relating to Company’s Confidential
Information (“Inventions”) and according to the License Agreement that was
signed with THM on December 2014. The Fund and the Investigator shall further
disclose and furnish to Company all results of the Study and data generated in
the performance thereof except Study Subject medical records (collectively, the
“Results”) and all reports, records and other material, allowable by law that
may be prepared by or on behalf of the Fund or the Investigator or any of the
Study Personnel in connection therewith or relating to Company’s Confidential
Information (“Reports”). During the execution of the Study, the Fund and/or the
Investigator shall provide the Company with: (i) periodical written status
Reports, which shall inform the Company of the progress of the Study, major
issues, if encountered, and shall summarize all the results of the Study during
the preceding report period and provide any other information reasonably
requested by the Company; (ii) any significant results or discoveries as soon as
practicable after the Fund becomes aware thereof; and (iii) a final written
report summarizing the results of the Study within such agreed upon time period
as of the end of the Study.         6.2. Subject to clause 5.1-2 above, the Fund
agrees to permit representatives of the Company to examine its facilities in
order to determine their adequacy, validate case reports against original data
in its files and monitor work performed to insure its compliance with the
Protocol. Such inspection shall be coordinated in advance with the Fund, shall
take place in times and dates mutually agreed upon and shall be conducted in a
reasonable manner that shall not interfere with or disturb the work and
activities being conducted in the Hospital.         6.3. The Fund and the
Investigator shall prepare and maintain records, reports and data as provided in
the Protocol and in accordance with all applicable laws and regulation.        
6.4. The Fund shall notify and provide the Company with copies of any inquiries,
correspondence or communications to or from any governmental or regulatory
authority related to the Study.         6.5. The Investigator shall be entitled,
consistent with academic standards, to publish the results of the Study, subject
to the stipulations set forth, provided that such publication does not
constitute a violation of Article 5.l above. In the event that the Investigator
desirers to publish the results as stated in this section, the Company reserves
the right to review, amend, modify and edit any paper written utilizing data
generated from the Study prior to such paper’s presentation or submission for
publication purposes. In addition, prior to submitting or presenting a
manuscript or other materials relating to the Study to a publisher, reviewer, or
any third party, the Fund shall provide the Company a copy of all such
manuscripts and materials, and allow the Company 90 days to review and comment,
such approval will not be unreasonably withheld. The Fund will give due
consideration to the Company’s comments and make its best efforts to take them
into account. The Fund and Investigator further agree to delay any publication
in accordance with this section, for an additional 120 days, at the request of
the Company, where the Company considers such delay necessary for the protection
of its intellectual property rights.         6.6. If the Study is a part of a
multi-center study and the Company wishes to publicize a joint publication which
includes results of all centers, then the Investigator shall not publicize the
Study results before the first joint publication, unless such publication is not
published within 12 month from the completion of the Study at the Hospital.

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  6.7. The Company undertakes to avoid using, directly or indirectly, the name
of the Hospital and/or the Fund and/or the Investigator and/or any of the Study
Staff, in the Company’s commercial publications, as parties recommending the
quality and/or the effectiveness of the Study Drug.         6.8. The Company
undertakes that should it publicize the results of the Study, it shall publish
the results in full and avoid quoting matters out of context.

 

7.  STUDY RESULTS, PROPRIETARY RIGHTS AND INVENTIONS:

 

    All rights to any invention, Reports and Study results, whether or not
reduced to practice as a direct result of the performance of the Study shall be
as detailed in the Research Collaboration and License Agreement dated December
2014 attached hereto as Schedule D to this Agreement and constituting an
integral part thereof.

 

8. TERM AND TERMINATION:

 

  8.1. The term of this Agreement shall be from the date of its execution by the
last Party (subject to approval as conditioned in clause 2 above, whichever is
later) until the Study is either completed according to the Protocol or
terminated. It is anticipated that the Study should be completed according to
the Protocol.         8.2. The Company retains the right to terminate the Study
at any time and for any reason whatsoever, subject to thirty (30) days prior
written notice. In the event such early termination occurs, or in the event of
any early termination whatsoever, which is not due to a breach of this Agreement
by the Fund or by the Investigator or by any of the Fund’s employees, agents or
officers, the Company shall pay the Fund all the following payments:        
8.3. The costs of non-cancelable items.         8.4. The payment of the agreed
Remuneration which shall be prorated according to Article 9 and Schedule E.    
    8.5. The full Storage Fee, as defined bellow         8.6. The rights and
duties under Article 5 (Confidentiality), Article 6 (Reports and Publications)
and Article 7 (Study results, Proprietary Rights and Inventions), shall survive
the termination or expiration of this Agreement for any reason.

 

9. REMUNERATION:

 

  9.1. In return for the Fund’s obligations hereunder, the Company undertakes to
pay the Fund the amounts specified in the payment schedule listed in Schedule E
attached to this Agreement and constituting an integral part thereof (the
“Remuneration”). Notwithstanding anything to the contrary in Schedule E, the
Company shall pay the Fund, within seven (7) days from the date of execution
hereof, an advance payment of 15% (fifteen percent) of the total Remuneration.  
      9.2. The Company shall pay the Fund, for each 12-month period, 3,500 NIS
(three thousand and five hundred NIS), plus 15% overhead in return for the
storage of the Study Drug in the Pharmacy (“Storage Fee”). In addition, the
Company shall pay any other fees, as specified in Schedule D for the preparation
and/or sterilization and/ or any other care required to be performed by the
pharmacy.         9.3. The Fund shall provide the Company with a receipt for
each installment paid.         9.4. The Company shall pay the costs of medical
treatment required by any Subject for any illness or condition caused by the
performance of the Study and/or the Study Drug and/or procedure required by the
Protocol, provided that the Study is administered in accordance with the
Protocol and without negligence or willful misconduct, or failure to act on the
part of the Fund, Study Staff or the Investigator.

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  9.5. The Fund and Company agree that if the Fund received reimbursement from
any healthcare program or other insurance of the Subject, the Fund will not seek
reimbursement of such medical expenses from the Company. If Fund receives
payment from any health care or insurance program for medical expenses already
reimbursed by Company hereunder, Fund shall promptly notify Company and
reimburse Company for such payments.

 

10. CLAIMS, LIABILITY AND INSURANCE:

 

  l0.1. The Company shall bear sole responsibility, pursuant to the applicable
law and this Agreement, and bear any payment and/or compensation and/or
liability for any damage whatsoever caused, directly or indirectly, to any
person, as a result of the performance of the Study and/or a derivative thereof
(the: “Damages”) unless such Damages arose out of the negligence, willful
misconduct of the Fund or any on its behalf.         10.2. The Company shall
indemnify and hold harmless, the Fund, the Hospital, the Study Staff, the
Investigator and their employees and/or agents and/or officers and/or
representatives involved in the performance of the Study (the “Beneficiaries”)
from and against any and all claims, demands, causes of action and suits of
whatsoever kind or nature based on damages claimed to have been caused as a
result of the following: (i) the performance of the Study and/or (ii) any
procedures prescribed in the Protocol and/or pertaining to the Study and/or
(iii) the use by the Company of the results of the Study and/or (iv) the
administration, use marketing or consumption of the product to which the results
relate (the “Loss”). The above indemnity shall not apply where:

 

  10.2.1. The Loss was caused as a result of negligence, malfeasance or willful
misconduct of the Fund and/or the Investigator and/or the Study Staff; or      
  10.2.2. The Loss was caused as a result of a failure, by the Fund and/or the
Investigator and/or the Study Staff, to comply with the terms of the Protocol or
other written instruction of the Company concerning use of the Study Drug or
device and/or this Agreement and/or failure to comply with any applicable laws.

 

  10.3. Subject to that stated above in this Section 10, the Company shall pay
all expenses associated with any proceedings taking place as a result of a
complaint and/or legal claim submitted by any person in respect of the Loss.    
    10.4. For the purpose of the Indemnity pursuant to section 10.2 above the
Fund undertakes as follows: (i) The Fund shall notify the ·company, within 15
(fifteen) days from the day the Fund acquired such knowledge, of any claim, or
injury relating to the Study; (ii) the Beneficiaries shall permit the Company to
assume full responsibility for the investigation of, preparation for, and
defense of, any claim for which indemnification is being sought; and (iii) the
Beneficiaries agree to cooperate with Company in the defense of any claim or
suit relating to the Loss and permit Company to have the exclusive right to
control the defense and/or settlement of any such claim or suit, including
without limitation the right to select- defense counsel, provided that Company
shall not have the right to settle any such claim or suit without the prior
written consent of the Fund unless such settlement only involves the payment of
money and the Beneficiaries are given an unconditional release from all
liability by the claimant therein.

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  10.5. Without derogating from its liabilities stated above, the Company shall
at its own expense insure its liability pursuant to this Agreement, including
this clause 10 for the term as follows: (i) if the insurance policy is on claims
occurred basis - for the term of this Agreement or (ii) if the insurance policy
is on claims made basis -for the period of this Agreement plus an additional
period until the limitation term of any Loss have elapsed according to the
Israeli Limitation Law. Such insurance shall be in reasonable amounts which
shall not be less than $3,000,000 (three million) USD and on reasonable terms in
the circumstances, having regard, in particular, to the nature of the Study and
the Study Drug. The named insured under such insurance shall be the Company and
the Beneficiaries. The policy or policies so issued shall include a
“cross-liability” provision pursuant to which the insurance is deemed to be
separate insurance for each named insured (without right of subrogation as
against any of the insured under the policy, or any of their representatives,
employees, officers, directors or anyone in their name) and shall further
provide that the insurer will be obliged to notify each insured in writing at
least 30 (thirty) days in advance of the expiry or cancellation of the policy or
policies. The Company undertakes that such insurance shall include any future
amendments to the Protocol.         10.6. This clause 10 shall survive the
termination of this Agreement and remain in full force and affect.         10.7.
The Fund and its officers, employees, directors and agents and the clinical
studies conducted at the Hospital are covered under professional liability
insurance in the framework of an insurance arrangement, in accordance with
applicable law and regulation and as customarily maintained by governmental
hospitals in Israel.

 

11. Disclaimers:

 

  11.1. Under no circumstances the liability of the Beneficiaries to the Company
under or arising out of this Agreement whether for breach of contract, in tort
(including, but not limited to, negligence) or otherwise shall exceed in
aggregate a sum equal to the remuneration.         11.2. Company’s
indemnification liability pursuant to this Agreement shall be limited to the
amounts of insurance purchased by Company pursuant to Section 10.5 above.

 

12. LAW AND VENUE:

 

    Any dispute between the parties to this Agreement, including its breach
and/or its implementation and/or its termination, shall be decided exclusively
by the competent court of law in Tel-Aviv, Israel which shall have exclusive
jurisdiction and the law that shall apply shall be the statutes and laws of the
State of lsrael.

 

13. MISCELLANEOUS:

 

  13.1. Superiority. Should any contradiction arise between the provisions of
this Agreement and any of its appendices (excluding the Protocol), including the
payment schedule and/or any other document executed in connection with this
Agreement, save for Form 4A, the provisions of this Agreement shall prevail.    
    13.2. Non-employment. For the purpose of this Agreement, the Fund and/or the
Study Staff and/or the Investigator shall be deemed an independent contractor
and shall not be considered a partner, agent, employee or representative of the
Company.         13.3. Good Faith. Both parties shall be under a duty to act in
good faith in the performance and enforcement of this Agreement.

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  13.4. Continuing Obligations. The rights and obligations of each of the
Parties hereto under any provision of this Agreement, which is expressly or by
implication intended to survive beyond the term of this Agreement, including but
not limited to those provisions relating to Publication Rights, Confidentiality,
Indemnification and Insurance, and Intellectual Property Rights, shall survive
the expiration or termination of this Agreement for any reason.         13.5.
Notices. Except as otherwise provided in this Agreement, all notices permitted
or required by this Agreement shall be in writing and shall be deemed to have
been duly served (i) upon personal delivery (ii) upon facsimile transmission
(receipt of which has been orally confirmed by the recipient) or (iii) Seven (7)
business days after deposit,postage prepaid, return receipt requested, if sent
by registered mail and addressed to the address of the parties first above
stated or in accordance with such other address information as the party to
receive notice may provide in writing to the other party in accordance with the
above notice provisions. Any notice given by any other method will be deemed to
have been duly served upon receipt thereof.         13.6. Assignment. This
Agreement is personal to the Parties and may not be assigned without the prior
written consent of the other Party. Notwithstanding the above, the Fund shall be
entitled to assign its rights and obligations hereunder to any legal entity
established in connection with or for the benefit of the Hospital, provided
however, that such legal entity shall assume in writing all the obligations
under this Agreement         13.7. Captions. Any paragraph or other captions are
inserted for convenience only and shall not be considered a part of or affect
the interpretation or construction of any of the provisions of this Agreement.  
      13.8. Waivers. No course of dealing in respect of, nor any omission or
delay in the exercise of, any right, power, or privilege by either Party shall
operate as a waiver thereof, nor shall any single or partial exercise thereof
preclude any further or other exercise thereof or of any other, as each such
right, power, or privilege may be exercised either independently or concurrently
with others and as often and in such order as each party may deem expedient.    
    13.9. Entire Agreement; Amendments. This Agreement, including, without
limitation, its schedules, contains the entire agreement of the Parties with
respect to its subject matter. No oral or prior written statements or
representations not incorporated herein shall have any force or effect, nor
shall any part of this Agreement be amended, supplemented, waived or otherwise
modified except in a writing signed by both Parties.         13.10.
Severability. If any provision of this Agreement is determined by a court of
competent jurisdiction to be invalid, illegal, or unenforceable, that
determination shall not affect any other provision of this Agreement, and each
such other provision shall be construed and enforced as if the invalid, illegal,
or unenforceable provision were not contained herein.

 

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I, the undersigned, Dr. Barzilay, hereby declare and confirm that I read and
understood the Agreement, I agree to be appointed as the Investigator of the
Study on behalf of the Fund, and I undertake to comply with all the conditions,
provisions, instructions and stipulations of the Agreement.

 

The Investigator

 

December 29, 2016

 

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