Nevada
(State
or other jurisdiction
of
incorporation)
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000-50298
(Commission
File Number)
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98-0376008
(IRS
Employer
Identification
No.)
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ITEM
1.01
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ENTRY
INTO A MATERIAL DEFINITIVE
AGREEMENT
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ITEM
9.01
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FINANCIAL
STATEMENTS AND EXHIBITS.
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(c)
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Exhibits
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10.1
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Consulting
Services Agreement by and among Oramed Ltd., HADASIT Medical Research
Services and Development Ltd., Prof. Itamar Raz and Dr. Miriam Kidron,
entered into as of July 8,
2009.
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ORAMED PHARMACEUTICALS
INC.
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|||
Dated:
July 9, 2009
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By:
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/s/
Nadav Kidron
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Nadav
Kidron
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|||
President,
CEO and
Director
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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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21
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1.
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STUDY,
INVESTIGATOR AND SITE
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A.
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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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B.
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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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C.
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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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A.
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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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B.
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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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3.
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INFORMED
CONSENT
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A.
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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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B.
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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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A.
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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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(1)
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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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(2)
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Confidentially
inspect all data and work product relating to the
Study.
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(3)
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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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(4)
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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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B.
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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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C.
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REPORTING
OF ADVERSE EVENTS
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D.
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INTERVAL
AND FINAL STUDY REPORTS
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A.
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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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(1)
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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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(2)
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Information
that is already independently known by the Investigator, , prior to its
disclosure; or
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(3)
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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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(4)
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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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(5)
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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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B.
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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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C.
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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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D.
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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
Investigator in their sole discretion, to comply with the above
provisions. It is hereby made expressly clear that no patient identifiable
information will be provided, or made available, to the Sponsor or any
party acting on its behalf, without the express written consent of the
patient.
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A.
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Notwithstanding
anything contained herein to the contrary, the Investigator and/or
Institution may publish the results of the Study, provided that the
Investigator and/or Institution have notified the Sponsor of their intent
to publish as set forth in Sub-Section B below. The Investigator and/or
Institution and the Sponsor shall be listed as co-authors on said
publication. Any said publication will require Sponsor’s prior written
approval and will not contain the Sponsor’s Confidential Information,
which for the purpose of this section shall not include the Study
results.
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B.
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The
Investigator will provide Sponsor with a copy of any proposed publication
or presentation materials (“Material”) and a written notice of intent (on
behalf of the Investigator or any Study staff at the Institution) to
publish or present the Material at least 45 days prior to the scheduled
presentation or publication submission date (the “Evaluation
Period”). The Sponsor shall use said 45 days to determine
whether it wishes to seek patent protection for said Material and shall
notify Investigator and Institution in writing, prior to the end of the
Evaluation Period, if it intends to seek patent protection. If Sponsor
decides to seek patent protection, it shall have an additional 30 days,
beginning from the end of the Evaluation Period (“Preparation Period”), to
prepare and submit any patent application it wishes. After such time,
Investigator and/or Institution shall be free to publish the Material,
subject to the limitations contained
herein.
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C.
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If
the Sponsor, in its reasonable judgement, needs additional time to seek
patent or other protection for the Material intended to be published or
presented, the Sponsor will notify the Investigator of such need within
the Evaluation Period and publication or presentation will be deferred
until such time that the Sponsor gives notification that such protection
has been applied for. Such deferrals will in no event extend
for a total of more than 15 days beyond the Preparation Period without
written agreement of the
Investigator.
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A.
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Subject
to Sub-Section C hereto, all intellectual property, including ideas,
documents, information, know-how, trade secrets, reports, analyses, data
and inventions, generated by the Investigator or the Institution or their
respective employees, agents or contractors, directly from the performance
of the Study and this Agreement (collectively, the “Proprietary Data”)
shall be owned by the Sponsor.
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B.
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The
Investigator and the Institution hereby assign and transfer to the Sponsor
all right, title and interest in such Proprietary Data and agree to take
all further acts reasonably required, at the Sponsor’s expense, to convey
title in such property to the Sponsor and/or to assist the Sponsor to
perfect and protect such rights.
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C.
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The
Proprietary Data shall not include and Institution and/or the Investigator
shall retain any and all rights, including intellectual property rights,
to any development processes, software (including codes), technology,
means, and know-how developed by the Institution and/or Investigator
and/or HMO, including, but not limited to, that which relate to data
collection, data management or project
management.
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D.
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Nothing
contained herein shall prevent Institution and/or HMO and/or Investigator
from using the Proprietary Data for academic research, non commercial
therapeutic and educational purposes only, provided that that every person
or entity making use of the proprietary data is explicitly made aware by
the Institution or the Investigator or HMO of the Sponsor’s proprietary
interest therein. Such use will be subject to Sponsor’s prior written
consent.
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A.
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Each
party shall defend, indemnify and hold harmless (the “Indemnifying Party”)
the other parties and any of their employees, agents or
contractors (collectively the “Indemnitees”) promptly upon
their first demand from and against any loss, damage, liability and
expense (including legal fees) arising out of or resulting from the
results or performance of the Study and/or from the direct or indirect
use, sale or manufacture of the Study and/or the Study results and /or of
products incorporating or involving such results and, without limitation
to the foregoing, from or against product liability claims or claims
regarding third party’s intellectual property rights; provided
however:
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(1)
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that
the Indemnifying Party’s indemnification obligations under this Section
shall be proportionately reduced to the extent the loss was caused or
increased by the negligence or willful misconduct of an Indemnitee (but
only to the extent that such demands, claims, or judgments are due to the
negligence or willful malfeasance of the
Indemnitees);
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(2)
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that
the Indemnifying Party is notified in writing as soon as practicable under
the circumstances of any complaint or claim potentially subject to
indemnification;
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B.
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The
Indemnitees shall be entitled, at their sole discretion, to either (i)
instruct the Indemnifying Party to assume defense of any litigation or
other legal procedure which entitles them to indemnification under this
Agreement, in which case the Indemnitees shall be entitled to approve the
choice of the legal counsel of the Indemnifying Party, such approval shall
not be unreasonably withheld, or (ii) to manage their defense themselves,
in which case the Indemnifying Party shall be responsible to any legal
expenses (including reasonable attorney fees) stemming from such procedure
and the results thereof.
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C.
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The
Sponsor shall reimburse Institution for reasonable and necessary medical
expenses incurred by Study Subjects as a direct result of the treatment of
adverse reactions resulting from the administration of Study drugs and/or
devices or procedures performed in accordance with the Protocol, provided
such expenses are not covered by the Study Subject's medical or hospital
insurance coverage and are in no way attributable to the negligence or
misconduct of any agent or employee of the Institution. No
other compensation of any type will be provided by the Sponsor to the
Study Subjects.
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D.
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Without
derogating from the aforementioned, the Sponsor warrants and undertakes
that it has purchased, and shall maintain during the entire term of the
Agreement and for all relevant times subsequent thereto (including under
applicable statues of limitation), sufficient insurance coverage for the
Study and for the Sponsor’s liabilities hereunder, including without
limitation, for claims relating to negligence of both Sponsor and of
personnel performing the Study, and for claims relating to product
liability, which insurance coverage shall be satisfactory to the
Institution. The Sponsor further undertakes that HMO, the Institution, the
Investigator and their employees will be included as co-insured in such
insurance policy/ies. The Sponsor represents that as of the date hereof,
it maintains the insurance policy that is annexed hereto as Schedule
D1.
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E.
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Disclaimer of Warranty.
Nothing contained in this Agreement shall be construed as a warranty by
the Institution and the Investigator that the results of the Study will be
useful or commercially exploitable or of any value whatsoever. In
addition, and without derogating from the aforementioned the Institution
and the Investigator disclaim all warranties, either express or implied,
with respect to the Study and any products that incorporate, integrate or
are designed based in whole or part, on the Study results (“Products”),
including without limitation implied warranties of merchantability,
efficacy and fitness for a particular purpose. The entire risk arising out
of the production and use of the Study and the Products and any
accompanying materials remains solely with the Sponsor, and the Sponsor
shall be solely responsible for any use of the Work and/or the
Product.
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F.
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Limitation on liability.
Without derogating from the above, and except in the event of gross
negligence, willful misconduct or medical malpractice to the Study
subjects, if the Institution or the Investigator are found liable (whether
under contract, tort (including negligence) or otherwise), then the
cumulative liability thereof for all claims whatsoever related to the
Study or the Products or otherwise arising out of this Agreement, shall
not exceed a total consideration actually paid to it by the Sponsor under
this Agreement. This limitation of liability is intended to apply to all
claims of the Sponsor without regard to which other provisions of this
Agreement have been breached or have proved
ineffective.
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G.
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Exclusion of Consequential
Damages. Neither party shall be liable (whether under contract,
tort (including negligence) or otherwise) to the other party, or any third
party for any indirect, incidental or consequential damages, including,
without limitation, any loss or damage to business earnings, lost profits
or goodwill and lost or damaged data or documentation, suffered by any
person, arising from and/or related with and/or connected to this
agreement even if such party is advised of the possibility of such
damages.
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A.
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This
Agreement shall become effective upon its execution by both parties and
shall be in effect during the entire period of the Study as set forth in
Schedule A hereto, unless terminated by the parties as set forth
herein.
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B.
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Hadasit
and the Sponsor may either terminate this Agreement upon the filing by any
person of a petition for the winding-up or liquidation or the appointment
of a receiver on most of the assets of the terminated party, if petition
has not been withdrawn or dismissed within 21 days of its filing. In
addition, each party may terminate this Agreement without further notice
in case the terminated party has breached this Agreement and did not cure
such breach within 21 days of delivery of a written notice from the
non-defaulting party. The Sponsor may terminate this Agreement without
prior notice as set in Section 1 (B)
hereto.
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C.
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In
addition, this Agreement may be terminated by either Hadasit or the
Sponsor for any other reason upon 60 days written
notice.
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D.
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In
the event that this agreement is terminated by the Sponsor, the Sponsor
shall reimburse the Institution for all costs and non-cancelable
commitments incurred prior such termination with regard to the performance
of this Agreement.
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E.
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Subject
to Sub-Section D above, upon termination of this Agreement, the
Investigator and the Institution shall return to the Sponsor any funds not
expended or irrevocably committed prior to the effective termination date.
However, and without derogating from the Institution’s rights under any
applicable law, the Institution may set-off from such funds any debts of
the Sponsor towards the Institution or the
Investigator.
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F.
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The
Sponsor shall be obliged notwithstanding the termination of this Agreement
for any reason to continue supplying any material and drug supplied by the
Sponsor and used in the Study in order to comply with applicable laws and
regulations and/or to avoid injury or harm to the Study
subjects.
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G.
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Termination
of this Agreement by either party shall not affect the rights and
obligations of the parties accrued prior to the effective date of the
termination. The rights and duties under Sections 6, 7, 8, 10, 14, and 16
will survive the termination or expiration of this
Agreement.
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ORAMED
LTD
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By:
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/s/ Nadav Kidron
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Name:
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Nadav Kidron
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Title:
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Chief Executive Officer
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Date:
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INVESTIGATOR:
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/s/ Miriam Kidron
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Dr.
Miriam Kidron
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/s/ Itamar Raz
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Prof.
Itamar Raz
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By:
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/s/
Yuval Kupits
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/s/ Menachem Katz | |||
Name:
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Yuval
Kupits
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Menachem Katz | |||
Business
Development Manager
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CFO | ||||
Date:
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1.
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For
the performance of the Study, the Sponsor shall pay Hadasit the amount of
$400,000 (four hundred thousand U.S. Dollars) (the “Study fee”), payable
in accordance with the following
schedule:
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2.
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In
addition, the sponsor shall pay Hadasit, on a monthly basis, an amount of
NIS 3,000 (three thousand New Israeli Shekel) (the “Monthly Fee”) plus VAT
for the services provided by Dr. Roei Eldor, who is working with Prof.
Raz, under this agreement. Such payment will commence retroactively from
June 2008 and will continue until termination of the Agreement.
Notwithstanding the agreed above, the study that will be carried out by
Prof. Raz through Dr. Eldor, can be terminated without cause on thirty
(30) days’ prior written notice upon the sponsor decision
.
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3.
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It
is hereby agreed by the parties that no overhead charges will be charged
by Hadasit to the funds paid by
Sponsor.
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4.
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The
compensation detailed above shall constitute the complete compensation to
be paid by the Sponsor to Hadasit for the Study and include all fees,
charges and expenses that the Sponsor is obligated to pay under the
Agreement
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5.
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Sponsor
will have no obligation or liability in respect of payments to be made by
Dr. Kidron and/or her research
fund.
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6.
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At
the termination, for any reason, of the Agreement any unused funds in Dr.
Kidron’s research fund will be returned to the
Sponsor
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7.
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TAXES. If required under
Israel law, Sponsor shall add VAT to any payments made under this
Agreement to the Institution. Any payment shall be made against the
provision of tax invoice by the
Institution.
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8.
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INTEREST.
Any amount payable hereunder, which has not been made upon its due date of
payment, shall bear interest from the date such payment is due until the
date of its actual payment, according to the following: (i) any amounts
due in Israeli currency shall bear the maximum interest charged by Bank
Leumi Le Israel B.M. for unapproved overdrafts; (ii) any amount due in
foreign currency shall bear the same interest charged by Bank Leumi Le
Israel B.M. for a loan of the said amount in the said currency plus an
annual compounded interest at a rate of
3%.
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