CLINICAL TRIAL
AGREEMENT
This Agreement
is entered into as of July 8, 2009 by and between HADASIT MEDICAL
RESEARCH SERVICES AND DEVELOPMENT LIMITED, a company duly
incorporated under the laws of Israel, of P.O. Box 12000, Jerusalem
91120, (hereinafter: “ Hadasit ” or the “
Institution ”) and Prof. Itamar Raz and Dr. Miriam
Kidron (the “ Investigator ”) on one hand and
Oramed Ltd., a corporation organized under the laws of the state of
Nevada, with its registered office located at 2/5 Hi-Tech Park
Givat-Ram P.O. Box 39098, Jerusalem 91390, (hereinafter: “
Sponsor ”), on the other hand.
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PREAMBLE
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1
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1.
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STUDY,
INVESTIGATOR AND SITE
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2
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2.
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COMPLIANCE
WITH LAWS, REGULATIONS AND GUIDELINES
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3
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3.
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INFORMED
CONSENT
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3
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4.
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RECORDKEEPING, REPORTING AND
ACCESS
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4
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5.
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COMPENSATION
FOR STUDY
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5
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6.
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CONFIDENTIAL
INFORMATION
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5
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7.
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PUBLICATIONS
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6
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8.
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INTELLECTUAL
PROPERTY
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7
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9.
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TANGIBLE
MATERIALS
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8
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10.
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INDEMNIFICATION, INSURANCE, LIMITED
LIABILITIES
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8
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11.
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TERM AND
TERMINATION
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10
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12.
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CHANGES TO
THE PROTOCOL
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11
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13.
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ASSIGNMENTS
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11
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14.
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APPLICABLE
LAW
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12
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15.
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INDEPENDENT
CONTRACTORS
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12
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16.
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NOTICES
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12
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17.
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ENTIRE
AGREEMENT
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12
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Schedule A
– Protocols
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15
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Schedule B -
Compensation
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16
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Schedule C -
Materials
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18
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Schedule D -
Insurance policy
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19
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Schedule E
– First Agreement
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20
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Schedule F
– Second Agreement
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PREAMBLE
WHEREAS Hadasit
is a wholly owned subsidiary of Hadassah Medical Organization
(“ HMO ”) and is authorized to enter this
Agreement and to utilize HMO’s facilities, employees and
agents for purpose of this Agreement;
Whereas , the Sponsor is the successor of Integrated
Security Technologies, Inc. (“ IST ”);
and
Whereas , on February 17, 2006 Hadasit and IST have
entered into the agreement regarding Method of Replacing Insulin
Injections with Oral Insulin attached hereto as Schedule E
(the “ First Agreement ”); and
Whereas , Section 5 of the First Agreement contains
certain terms and conditions in connection with Clinical Trials (as
defined in the original agreement) to be performed by IST and
Hadasit as well as funding requirements for said Clinical Trials;
and
Whereas, on
January 9, 2009 Hadasit and Oramed have entered into an agreement
replacing the First Agreement attached hereto as Schedule F
(the “ Second Agreement ”); and
WHEREAS the
Sponsor is in the process of development of administration and
delivery of peptides into the body (hereinafter: the “
Product ”) and has prepared the Protocol in order to
conduct clinical trials for further investigation of the
Product.
WHEREAS the
Sponsor represents that it is the sole owner of any and all
intellectual property rights in the Product and the Protocol (as
such term is defined herein), and that the execution and delivery
of this Agreement does not infringe any third parties’ rights
and/or any applicable law;
WHEREAS, the
SPONSOR has previously invested and is willing to invest certain
funds in the Study (as hereinafter defined) to be carried at
HMO’s facilities by the Investigator under the terms and
conditions herein;
NOW THEREFORE, the parties agree as
follows:
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1.
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STUDY,
INVESTIGATOR AND SITE
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Hadasit shall
contribute the Investigator for purpose of carrying out clinical
trials (the: “ Study ”) in accordance with the
Sponsor Protocols (the “ Protocols ”), which
have been drafted by the Sponsor at its sole responsibility. A list
of said protocols and a copy of each Protocol is attached herein as
Schedule A .
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The
Investigator will be responsible for performing the Study and for
the direct supervision of any individual performing portions of the
Study.
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In the event
that the Investigator ceases to be available for purpose of the
Study (including without limitation the event of termination of
employment between HMO and the Investigator for any reason
whatsoever), Hadasit shall use its best efforts to procure within
30 days his/her substitution by a suitably qualified person
acceptable to Sponsor. If such substitute is not acceptable to the
Sponsor, Sponsor shall be entitled to terminate this Agreement
without further notice, and this shall be Sponsor’s sole
remedy in such circumstances except as further defined in Schedule
B.
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Notwithstanding
anything to the contrary herein, the Sponsor hereby represents and
warrants that it has examined the facilities of the Institution and
found them entirely adequate and suitable for the purpose of
performance of the Protocol and the Study. In addition, nothing
contained herein shall be construed as casting upon the
Institution, the Investigator or HMO an undertaking to purchase any
equipment for purpose of the Study or to improve its existing
equipment.
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2.
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COMPLIANCE
WITH LAWS, REGULATIONS AND GUIDELINES
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The
Investigator will perform the Study in conformance (i) with the
Protocols, (ii) with all applicable laws and regulations, including
laws and regulations governing the performance of clinical studies
and (iii) with all applicable standards, regulations or guidelines
for good clinical practice (“ GCP ”) and ethical
conduct in connection with clinical studies, including those of the
Institution and HMO.
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Prior to
commencement of the Study, the Investigator will seek at the
Sponsor’s expense any consents or approvals that must be
obtained from the HMO’s ethics committee (the “
Committee ”). The Investigator will comply
with all requirements established by the Committee and agrees to
execute such assurances and other documents as the Committee may
reasonably request. The Sponsor shall assist the
Investigator to the extent required in this regard including,
without limitation, signing the relevant forms and amending the
Sponsor’s documents which shall be filed with the Committee.
The Investigator will not enroll patients in the Study until the
Protocol has been reviewed and approved by the Committee. The
Sponsor shall be liable to obtain any further approval that may be
required under applicable law. Any delay in the performance by the
Institution and/or the Investigator’ of any of their
undertakings hereunder due to insufficient approvals shall not be
deemed to be a breach of this Agreement by them.
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The
Investigator will be responsible for obtaining the written informed
consent of each subject participating in the Study (or his or her
authorized legal representative) before his or her participation in
the Study. The form that shall be used in this regard
shall be drafted by the Sponsor and approved by the Investigator;
however the Sponsor shall be solely responsible for the content
thereof as part of the Study’s documents.
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Without
derogating from the generality of the aforementioned, the parties
agree that such informed consent shall be granted only under
circumstances that provide the prospective Study subject (or his or
her representative) with sufficient opportunity to consider whether
or not to participate and that minimize the possibility of coercion
or undue influence. The parties further agree that any
such written informed consent shall be obtained in compliance with
all applicable laws, regulations, standards or
guidelines.
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4.
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RECORDKEEPING, REPORTING AND
ACCESS
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ACCESS. The
Sponsor and/or any regulatory authorities may, to the extent
reasonably necessary or to the extent required by applicable laws,
regulations, standards or guidelines, subject to prior coordination
with the Investigator and at the normal working hours in HMO (i.e.
8:00AM-16:00 PM):
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Examine and
inspect the Investigator’ and the Institution's facilities
required for performance of the Study; and
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Confidentially
inspect all data and work product relating to the Study.
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Receive, on a
quaterly basis, a detailed report on the expenses incurred in
connection with the study which are charged to Dr. Kidron’s
Research Fund
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Notwithstanding
anything to the contrary herein, any information and/or data to be
provided to the Sponsor under Sub Sections 1-3 above or under any
other provision hereunder, shall be subject to the provisions of
section 6(D) below and to the rights of the Subject of the Study
for medical confidentiality and privacy under any applicable law or
regulation (including, without limitation, HMO’s internal
procedures).
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The
Investigator shall prepare and maintain reasonably complete and
accurate written records, accounts, notes, reports and data of the
Study, including case report forms and shall provide Sponsor with
copies of all such documentation upon request. The Investigator
will retain or will cause the Institution to retain all such
materials and data that the Institution has to retain under any
applicable law for such periods as such law determines. After the
termination of such applicable retention periods, the Institution
shall no longer have any duty whatsoever to retain any such
materials and data.
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REPORTING OF
ADVERSE EVENTS
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The
Investigator shall promptly advise the Sponsor of any serious
adverse event or unanticipated adverse effect occurring during the
Study, or subsequent to the completion or termination of the Study,
that becomes known to him.
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INTERVAL AND
FINAL STUDY REPORTS
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During the
course of the Study, the Investigator shall provide the Sponsor
with quarterly interval reports (to be provided within 60 days of
the end of each quarter with respect to such quarter) including
copies of patient case report forms. The Investigator
will deliver a final written Study report to the Sponsor within 3
months from the Study’s completion.
5. COMPENSATION
FOR STUDY
The Sponsor
will pay compensation to the Institution for the performance of the
Study as set forth in SCHEDULE B hereto.
6. CONFIDENTIAL
INFORMATION
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Subject to the
publication rights set out in section 7 below, the Investigator and
the Institution agree to keep in confidence any written information
expressly marked as “confidential” that is forwarded by
the Sponsor to the Investigator or the Institution for purpose of
the Study (or such oral information which is clearly defined as
confidential upon its disclosure provided it is followed by a
written notice specifying the information so disclosed and its
being confidential within 30 days of such disclosure); or (b)
information that the Proprietary Data of the Sponsor as defined in
section 8 hereto (the information described in clauses (a) and (b)
above being collectively the “ Confidential
Information ”). However, the obligation of
non-disclosure and non-use shall not apply to the
following:
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Information
that is or becomes publicly available other than as a result of
disclosure by the Investigator or the Institution;
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Information
that is already independently known by the Investigator, , prior to
its disclosure; or
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Information
that was independently developed by employees of the Institution or
of HMO who have not been exposed to the Confidential
Information;
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Information at
or after such time that is disclosed on a non confidential basis to
the Investigator or the Institution or the HMO, or their employees,
by a third party; or
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Information
that the disclosure thereof is required under any law, court writ
or any competent authority. However, if the Investigator and/or the
Institution are legally required to disclose any Confidential
Information to a court or governmental authority, prompt written
notice thereof shall be given to the Sponsor.
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The obligations
of non-disclosure and non-use hereunder shall continue for 5 years
after the termination of this Agreement for any reason
whatsoever.
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At the request
of the Sponsor, the Investigator or the Institution, as the case
may be, will return to the Sponsor all copies or other
manifestations of Confidential Information that may be in the
possession of the Investigator or the Institution, except for
materials that have to be retained by the Investigator or the
Institution as aforementioned and subject further to Section 4(B)
hereto.
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Confidentiality of Medical
Records Sponsor, Investigator, and Institution
understand, acknowledge and agree that they share the common goal
of securing all individually identifiable health information and
according that information the highest possible degree of
confidentiality and protection from disclosure; accordingly, all
individually identifiable health information shall at all times be
treated as confidential by the parties in accordance with all
federal, state and local laws, rules and regulations governing the
confidentiality and privacy of individually identifiable health
information as applicable, including, but not limited to, the
Health Insurance Portability and Accountability Act of 1996
(“HIP AA”) and any regulations and official guidance
promulgated thereunder, as well as the Israeli Patient’s
Rights Law, 1996 (the “PR Law”), the Israeli Protection
of Privacy Law, 1981 (the “PP Law”) and any regulations
and rules 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 HIP AA regulations and official
guidance, as well as the PR and PP Laws and any regulations and
rules promulgated thereunder. It is hereby agreed that any
undertaking of the Institution and/or Investigator hereunder
whatsoever is subject to any restrictions and/or limitations deemed
necessary by the Institution and/or Inv
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