Agreement for Clinical Trials (without CRO)
EXHIBIT
10.28
(without
CRO)
This Agreement for Clinical Trials
(without CRO) (hereinafter, this “Agreement”) is made this 18 day of March 2010 by and between Medgenics Medical
Israel, Ltd., a company
organized and existing under the laws of the State of Israel with offices
at Misgav Business Park,
Misgav, Israel (hereinafter - the Company), and The Medical
Research,
Infrastructure, and Health Services Fund of the Tel Aviv Medical Center,
a ____________
organized and existing under the laws of the State of Israel with offices at
_____________________ (hereinafter - the Fund), and ▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, an
individual residing at _________________________, and having Israeli I.D. No.:
5556763-0 (hereinafter - the
Principal Investigator). Each of the Company, the Fund, and the Principal
Investigator may be referred to herein as a “Party” and collectively as the
“Parties”.
Whereas:
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a.
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The
Company has expressed its interest in managing the Clinical Trial, the
subject of which is “Safety and Efficacy of Sustained Erythropoietin
Therapy of Anemia in Chronic Kidney Disease Patients using EPODURE
Biopump” (hereinafter: the “Trial”), with Company’s code name
“EPODURE Trial”, bearing protocol No. MG-001-02, a copy of which is
attached as Appendix
A hereto
(hereinafter: the “Trial Protocol”);
and
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b.
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The
Company has warranted that to the best of its knowledge it is either the
sole owner of, or has license to, the intellectual property rights in the
Product, as defined below, and the Trial Protocol, and there is no
prohibition under any law and/or agreement to the Company executing this
Agreement and performing its obligations hereunder in all material
respects; and
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c.
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The
Fund and the Principal Investigator have the ability, the facilities and
the staff to perform the Trial, and the Fund and the Principal
Investigator have agreed to perform the Trial, without any promise of
success. The Fund and the Principal Investigator have warranted that there
is no prohibition under any law and/or agreement to the Fund or the
Principal Investigator executing this Agreement and performing their
respective obligations hereunder in all material respects;
and
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d.
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The
Company has agreed to pay the Fund the consideration, specified in Appendix
C hereto, for the
performance of the undertakings of the Principal Investigator and the Fund
under this Agreement; and
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e.
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The
Company shall not pay the Principal Investigator any consideration, it
being agreed that the Principal Investigator will conduct the Trial under
the auspices of the Fund and in consideration of whatever compensation the
Fund will pay to the Principal Investigator pursuant to a separate
agreement among them.
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NOW, THEREFORE, in
consideration of the Parties’ mutual covenants and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows:
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1.
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Preamble and
Appendices
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a.
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The
preamble to this Agreement and the representations contained therein
constitute an integral part of the
Agreement.
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b.
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The
appendices appended to this Agreement, as specified hereunder, constitute
an integral part of the Agreement:
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Appendix
A - Trial Protocol
Appendix
B - List of Trial Personnel
Appendix
C - Trial Budget and Schedule of Payments
Appendix
D - Directives of Ministry of Health
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c.
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The
provisions of this Agreement shall prevail - in the event of a
contradiction or non-compliance - over the provisions of any appendix
attached to this Agreement or which shall be attached hereto in the
future, unless said appendix explicitly provides that its provisions shall
prevail over this Agreement. However, existing and/or future Ministry of
Health regulations and/or guidelines shall prevail over the provisions of
this Agreement and/or any appendix provided that said regulations and/or
guidelines are stricter regarding the Company’s undertakings than the
Company’s undertakings under this Agreement and/or any
appendix.
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2.
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Definitions
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In this
Agreement, the following terms when capitalized shall have the following
meanings set forth below:
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“Ministry
of Health Approval”
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Approval
of the Director General of the Israeli Ministry of Health, or to whomever
he/she delegated the authority for this purpose, for the performance of
the Trial by the Fund according to the National Health
Regulations.
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“Hospital”
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The
Tel-Aviv Sourasky Medical Center.
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this
“Agreement”
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This
Agreement and its appendices.
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the
“Product(s)”
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BIOPUMP
implanted tissue platform for sustained production and delivery of
erythropoietin
(EPODURE)
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the
“Trial”
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as
defined in Preamble clause “a”, i.e., the Clinical Trial, which shall be
performed under this Agreement and the Trial Protocol, as each may be
modified or updated from time to time subject to the consent of Fund and
Company in writing and in advance.
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the
“Helsinki Declaration”
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the
Declaration containing the recommendations guiding investigators in
biomedical trials involving human beings, Helsinki 1964, as amended in
Tokyo 1975, and a draft of which appears in the attachment to the National
Health Regulations.
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“Trial
Protocol”
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as
defined in Preamble clause “a”, and appended hereto as Appendix “A” to
this Agreement, as may be modified or updated from time to time subject to
the consent of the Fund and the Company in writing and in
advance.
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the
“IRB”
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the
Internal Review Board appointed pursuant to the National Health
Regulations, the role of which is to approve any medical experiment on
human subjects that will be conducted by the Fund.
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“Trial
Personnel”
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the
team that shall be employed by the Hospital or the Fund for conducting the
Trial, including the Principal Investigator.
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“Participants
in the Trial”
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A
group of persons chosen by the Principal Investigator according to
criteria established in the Trial Protocol.
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“GCP”
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Ethical
and scientific quality standards for designing, conducting, recording, and
reporting trials that involve the participation of human subjects, as
customized by the Fund.
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“National
Health Regulations”
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National
Health Regulations (Medical Trials on Humans),
5741-1980.
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3.
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The
Engagement
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3.1
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Upon
signing this Agreement, the Company appoints the Fund and the Principal
Investigator, and those two parties undertake, each of them pursuant to
its authority and share, to perform the Trial according to the stages
thereof, within the framework and by means of the Hospital and to provide
all needed facilities, materials and services necessary to complete the
Trial, while complying with the schedule, the Trial budget and the Trial
Protocol in Appendix “A”, and while complying with the demands and terms
established by the Ministry of Health, and all pursuant to the terms and
conditions of this Agreement. The Fund shall be responsible for and obtain
all approvals required under any applicable law for the conduct of the
Trial.
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3.2
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Notwithstanding
sub-section 3.1 above, in the event that the employer-employee
relationship between the Principal Investigator and the Hospital and/or
the Fund is terminated for any reason and/or in the event the Principal
Investigator goes on leave and/or is unable and/or unwilling to carry out
his duties under this Agreement, for any reason, the Fund may appoint a
substitute Principal Investigator in place of the Principal Investigator
subject to the prior written approval of the Company, which shall not
unreasonably be withheld.
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4.
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The
Term of the Agreement
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4.1
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Subject
to the terms of this Agreement, the Term of the Agreement shall be the
duration of the Trial as defined in the Trial Protocol, which shall
commence on
and end upon completion of the Trial; provided, however, that the rights
and obligations under Sections 5.6, 6, 8, 9, 10, 11, 12 and 15 shall
survive the termination or expiration of this
Agreement.
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4.2
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Notwithstanding
the aforesaid in sub-section 4.1 above, but subject to the provisions that
survive termination, the Parties may bring this Agreement to an early end
at any time, in writing, upon the occurrence of one (or more) of the
following events: -
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4.2.1
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by
the Company only, at any time at its sole discretion, by way of a written
notice to the Fund, thirty (30) days in
advance.
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4.2.2
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if
the Ministry of Health has voided, directly or indirectly, its approval of
the Trial or has conditioned its approval on conditions, as to which the
Fund has notified the Company that it does not intend and/or is unable to
comply with these conditions in whole or in part. In such case the
Agreement shall be terminated not later than ten (10) days after such
notice shall have been sent to the
Company.
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4.2.3
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A
Party breaches this Agreement and does not cure such breach within thirty
(30) days after having received a notice in writing from the other Party
demanding a cure of the breach in reasonable detail so that the breaching
Party is on notice of the nature of the
breach.
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4.2.4
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A
party enters into bankruptcy or liquidation proceedings or a receiver is
appointed over part or all of its assets, and such proceedings are not
ceased within a period of forty five (45) days from the time that they
have commenced.
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4.2.5
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An
adverse effect occurs to the Participants in the Trial, which, in the
absolute discretion of the Fund and/or the Principal Investigator and/or
the IRB, jeopardizes the safety of the Participants in the Trial and/or
the Trial Personnel, and prior notice thereof is given immediately to the
Company by any member of the Trial Personnel and the Principal
Investigator within a reasonable time from the discovery of such adverse
effect. In such case the Agreement shall be terminated immediately after
such notice shall be sent.
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For the
removal of any doubt, it is agreed that the Principal Investigator may not
terminate this Agreement under this section.
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4.3
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For
the avoidance of any doubt, the termination of this Agreement, for any
reason, shall not prejudice the Company’s undertaking to pay the Fund for
all services and expenditures of the Fund under this Agreement until the
termination of the Agreement.
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5.
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The
Trial
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5.1
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The
Company shall supply to the Principal Investigator the Products and/or
parts of the Product and/or the materials from which the Product is
composed, without consideration, at the necessary pharmaceutical standard,
all in accordance with the schedule and in the quantities provided in the
Trial Protocol.
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5.2
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The
Trial shall be performed and managed by the Principal Investigator at the
Hospital facilities, while making use of the Hospital’s resources, without
payment of further consideration by the Company
therefore.
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5.3
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The
Principal Investigator shall carry out the Trial in accordance with the
Trial Protocol, GCP, and all the relevant laws and regulations prevailing
in Israel and in accordance with all necessary permits and/or licenses
from the relevant authorities.
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5.4
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In
performance of the Trial, the Fund shall employ, directly or indirectly,
the Trial Personnel, which will comprise the individuals specified in the
list appended herewith and marked as Appendix B to this Agreement. In the
event that any of the Trial Personnel so identified cease to be available
for the Trial, the Fund will use its best efforts to procure within 30
days a substitute of a suitably qualified person acceptable to the
Company. The Fund and the Principal Investigator represent and warrant
that none of the Trial personnel has been debarred, disqualified or banned
from conducting clinical studies by any regulatory agency, including the
Israeli Ministry of Health and the U.S. Food & Drug Administration. In
the event that prior to or during the Trial, the Fund or the Principal
Investigator become aware that any of the Trial Personnel becomes
disbarred, or is in the process of disbarment, the Fund will immediately
notify the Company in writing and the Fund will procure within 30 days a
substitute of a suitably qualified person acceptable to the
Company.
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5.5
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Subject
to the provisions of sub-section 11 below, the representatives of the
Company shall have the right to examine the results, notes and other
documents and representations obtained during the course of the Trial,
during regular working hours and confidentially inspect the Principal
Investigator’s and the Hospital’s facilities required for performance of
the Trial, after providing advanced written notice and at a reasonable
time.
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To avoid
any doubt, it is clarified that this sub-section and any provision of this
Agreement shall not be deemed as providing management and/or supervision
authority to the Company or to anyone on its behalf over the Trial and/or the
Principal Investigator and/or whomever of the Trial Personnel.
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5.6
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In
performance of the Trial, pursuant to this Agreement, the Company
undertakes to continue to supply the Product to the Fund and/or the
Hospital, without consideration, in order to complete the commenced
treatment of the Participants of the Trial at the Principal Investigator’s
sole and reasonable discretion, or as part of the Trial Protocol, should
one of the Participants of the Trial become dependent on the
Product.
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To avoid
any doubt, it is hereby clarified that this obligation of the Company shall
remain in effect even in the event that the Agreement has been terminated or is
voided for any reason, but only for so long as it shall be required under the
guidelines of the Ministry of Health.
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5.7
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Notwithstanding
the Company’s undertakings under this Agreement, the Company undertakes to
abide by all the relevant laws and regulations prevailing in Israel and in
accordance with and after all necessary permits and/or licenses from the
relevant authorities, as are presented to it by the
Fund.
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6.
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Reporting and
Follow-Up
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6.1
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The
Principal Investigator shall meet with the representatives of the Company,
during the customary working hours and to a reasonable extent, in order to
report to the Company, on an ongoing and consecutive basis, and in order
to update the Company in all matters related to the performance of the
Trial, its progress, difficulties, solutions, etc. The Principal
Investigator shall promptly advise the Company of any serious adverse
event or unanticipated effect occurring during the Trial, or subsequent to
the completion or termination of the Study, that becomes known to
him.
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6.2
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The
Principal Investigator shall prepare and maintain reasonably complete and
accurate written records, accounts, notes, report and data of the Trial,
including case report forms. The Principal Investigator shall prepare the
case reports forms (CRF) legibly and accurately (or ensure that a
co-Investigator does so) throughout the Trial, and shall make the CRF
available to the Company. The Principal Investigator will retain or will
cause the Fund to retain all such materials and data that the Fund has to
retain under any applicable law for such periods as such law
determines.
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6.3
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The
Principal Investigator hereby undertakes to adhere to the accuracy of the
Trial results as required by the Helsinki Declaration and the
GCP.
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7.
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Financing of the
Trial
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7.1
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In
consideration for the performance of the Trial under this Agreement, the
Company shall pay the Fund the consideration specified in Appendix C to
this Agreement on the dates specified in Appendix C. Such payments shall
be made against a proper invoice render a reasonable time in advance of
the due date for the payment.
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7.2
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To
avoid any doubt, it is hereby clarified that the Fund and/or the Principal
Investigator shall not perform any acts which deviate from the acts
specified in the Trial Protocol and/or are specifically mentioned in this
Agreement unless the Fund and the Company have both approved said acts, in
advance and in writing.
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8.
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Insurance
and Indemnity
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8.1
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The
Company shall indemnify and hold harmless the Hospital, the Fund, the
Principal Investigator, the Trial Personnel and all other employees of the
Hospital and the Fund (hereinafter: the “Indemnitees”) from and against
any loss, damage, liability and expense (including legal costs) arising
out of or resulting, directly or indirectly, from the use of the Products
and/or any other materials which have been supplied by the Company and/or
from conducting the Trial in accordance with the Trial Protocol, except to
the extent that such loss, damage, liability or expense are a result of
the negligent acts, willfulness, misconduct or breach of contract of any
of the Fund, the Principal Investigator or the Trial
Personnel.
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This
indemnity is subject to the following conditions:
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8.1.1
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The
indemnity shall not apply in case of claims or losses arising from a
breach of the Trial Protocol, GCP, Helsinki Declaration, National Health
Regulations, and/or any other applicable law or regulation relating to the
Trial.
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8.1.2
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The
Company will be notified promptly and in writing of any complaint or claim
promptly after the Fund becomes aware of the
same.
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8.1.3
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The
Company will be given absolute and sole discretion in the defense and
settlement of any such complaint or
claim.
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8.1.4
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The
Fund shall cooperate with and give the Company reasonable assistance in
connection with any such claim or proceedings at Company’s cost and
expense, and shall consent to any reasonable settlement of such complaint
or claim approved by the Company.
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8.2
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Without
derogation from Company’s liability under this Agreement and/or under any
applicable law, including the Ministry of Health Directive, Company
undertakes to present the Fund an Insurance Certificate according to the
law of Israel and the Guidelines of the Ministry of Health. The
Certificate will specifically include the following
provisions:
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Type of
insurance – one of the followings:
No Fault
Insurance for Clinical Trial with a specific sub-limit for not less than
$3,000,000 any one Occurrence and in the aggregate;
or
Liability
Insurance including coverage for Clinical Trials with a specific sub-limit for
not less than $3,000,000 any one Occurrence and in the aggregate.
The
policy shall include as additional insured the Fund, the Tel Aviv Sourasky
Medical Centre and/or their employees and/or the Principal Investigator and/or
Sub Investigators and/or the Ethics Committee and/or any medical personnel
involved in performing the Clinical Trial.
The
insurance coverage shall be in force until the Trail and the discovery period
shall be of 7 years.
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8.5.
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The
Company hereby undertakes that any and all settlements of indemnification
claims hereunder by the Company and/or its insurers will be free of
admission of any liability whatsoever on the part of the
Indemnitees.
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8.6.
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The
Company’s undertaking under this section shall survive termination of this
Agreement for whatever reason.
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9.
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Limitation of Liability.
The Parties agree that the Parties shall be liable for direct
damages only and that no Party shall be liable for indirect, incidental or
consequential damages in connection with the
Agreement.
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10.
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Intellectual
Property
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All
rights and title to and/or interests in the data, information, conceptions, and
results derived from the Trial and/or the Product as well as any inventions or
discoveries invented, patent applications, or discovered in connection
therewith, including without limitation, any materials, compositions, treatments
or methods which may be developed based thereon (hereinafter, collectively the
“IP”) are and shall be owned by and are and will be the sole and exclusive
property of the Company.
The Fund
and the Principal Investigator hereby assign and transfer and shall make efforts
to cause all Trial Personnel to assign and transfer to the Company all right,
title and interest to the IP and to any invention or other proprietary rights
relating to or deriving from the conduct of the Trial which are conceived,
reduced into practice or developed by them under or as a result of this
Agreement or the performance of the Trial and agree to take all further acts
reasonably required, at the Company’s expense, to convey title in such IP or
other proprietary rights to the Company and/or to assist the Company, at the
Company’s cost and expense, to perfect and protect such rights including by way
of preparation, filing, and prosecution of any patent application, copyrights,
or other rights on such proprietary rights and to maintain the same in any and
all countries.
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11.
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Exploitation of the Trial
Results
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It is
hereby agreed that the Company has and shall have the sole and absolute right,
without limitation of time or place, worldwide (i.e., in Israel or abroad),
subject only to limitations under the law and the regulations of the Ministry of
Health, to make any and all uses of the IP, including without limitation to
manufacture and/or market and/or sell and/or grant a right of use in the
production and/or marketing rights of the Product and/or accompanying products
which shall derive from the Trial, directly or indirectly, and rights to perform
research and development on said IP, including any modifications and/or
improvements of the same.
The Fund,
the Principal Investigator, the Trial Personnel and all other employees of the
Fund involved in conducting the Trial shall not have any claim or demand against
the Company for any payment, royalties or compensation of whatever type deriving
from the development or sale of any such medicine, medical devices, treatments
or methods or any other rights pertaining to the data, information and/or
results derived from conducting the Trial.
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12.
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Confidentiality
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12.1
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The
Fund and the Principal Investigator undertake to keep, and shall cause all
other Trial Personnel to keep, in absolute confidence, not to transfer or
disclose to any person and/or entity and not to make any use, other than
for purposes of the performance of the Trial, any information, data,
inventions, conceptions, results, or know-how, whether orally or in
writing, which shall come into their possession in relation to and/or in
connection with the Trial, the Trial Results and/or the Product and/or the
IP (hereinafter - the Confidential
Information).
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12.2
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It
is hereby clarified that submission of the Confidential Information
pursuant to the demands of the authorities operating by virtue of the law
and according to their authority, after prior written notice has been
delivered with respect to same to the Company, as well as the exposure of
Confidential Information, after it has become public domain, but not as a
result of its being published in a patent application or granted patent,
and not as a result of the acts and omissions of the Hospital, the Fund,
the Principal Investigator and/or any other Trial Personnel, shall not be
considered a breach of this
Agreement.
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12.3
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At
the request of the Company, the Principal Investigator or the Fund, as the
case may be, will return to the Company all copies or other manifestations
of Confidential Information that may be in the possession of the Principal
Investigator or the Fund, except for materials that have to be retained by
the Principal Investigator or the Fund in accordance with applicable
law.
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13.
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Publications
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13.1
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The
Principal Investigator and the Fund hereby undertake to submit to the
Company all drafts of any publications proposed for publication by the
Principal Investigator, no later than sixty (60) days prior to the
submission of any form of such publication or drafts thereof to any
journal, publisher, and/or any other third
party.
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13.2
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The
Company hereby undertakes to promptly inform the Principal Investigator
and the Fund of any changes and/or deletions the Principal Investigator is
to perform in such publications, required for the purpose of preserving
the confidentiality and proprietary rights of the Company under this
Agreement. It is agreed that the Principal Investigator and/or the Fund
shall not make any publication of information to which the Company objects
under this sub-section 12.2.
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13.3
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Without
derogating from the above, the Company hereby undertakes to abide by the
rules of publications issued by the Ministry of Health including and
without limitation the Guidelines for the Conduct of Clinical Trials in
Human Subjects issued by the Israeli Ministry of Health in 2006, or any
guidelines issued in addition thereto or in substitution
thereof.
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13.4
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As
a condition for performing the Trial, the Company shall be responsible for
publishing the Trial in the NIH web sites in accordance with the
instructions of the General Manager of the Israeli Ministry of Health
published in 4/9/05.
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14.
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Relations of the
Parties
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This
Agreement shall not create relations of agency and/or partnership and/or
employer-employee relations between the Company and the Fund and/or Hospital
and/or the Principal Investigator and/or the Trial Personnel.
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15.
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Suspending
Conditions
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The
Parties hereby agree and undertake that the Agreement shall not enter into
effect before the three (3) following cumulative approvals shall have been
granted with regard to the Trial; provided, however, that the rights and
obligations provided in Section 11 above shall be effective from the date of
execution of this Agreement:
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15.1
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Approval
of the Trial Protocol by the IRB and/or by the Ministry of Health, if
required by the National Health
Regulations.
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The
Principal Investigator shall submit the Trial Protocol to the IRB to obtain
approval for conducting the Trial and/or to the Ministry of Health, if required
by the National Health Regulations.
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15.2
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Approval
of this Agreement in general and its Budget by the Ministry of Health and
specifically by the Contracting Committee of the Ministry of
Health.
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15.3
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Pursuant
to section 8.5 of this Agreement, a written Confirmation of Insurance
shall be provided to the Fund.
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16.
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Governing Law and
Jurisdiction
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16.1
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This
Agreement shall be exclusively governed by the Laws of the State of
Israel.
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16.2
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Any
dispute, controversy or claim arising under, out of or relating to this
Agreement (and subsequent amendments thereof), its validity, binding
effect, interpretation, performance, breach or termination, including tort
claims, shall be exclusively referred to the competent courts in Tel Aviv,
Israel.
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17.
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Non-Waiver of
Rights
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A Party
to this Agreement shall not be considered as waiving its rights which it has
acquired pursuant to the same and by virtue thereof because it has failed to
ensure the immediate enforcement of any right or because it has granted another
Party an extension or delay, and a waiver or extension granted in one case shall
not be considered or regarded as a waiver or extension in another, whether in
the same matter or in another matter.
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18.
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Endorsement, Assignment and
Transfer
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A Party
to this Agreement shall not transfer, endorse or assign its debts, obligations
or rights pursuant to and by virtue of this Agreement, or a part thereof (each,
an “Assignment”), all as the case may be (hereinafter - the Transferor) to any
third party, unless the prior written consent of the other Parties has been
obtained. Notwithstanding the foregoing, the Fund shall not, without reasonable
ground, withhold its consent to any Assignment by the Company if such Assignment
is being made (a) to any entity that acquires fifty percent (50%) or more of
that Company’s shares or voting securities or all or substantially all of its
assets, or (b) as part of a reorganization, re-incorporation or merger of the
Company. Subject to the foregoing, this Agreement will benefit and bind the
parties’ successors and assigns.
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19.
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Cooperation between the
Parties
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The
Parties shall take all actions necessary to execute the provisions of this
Agreement, and shall cause that at each one of them all the decisions required
by this Agreement will be made and all the acts performed. The Parties shall
cooperate with each other and shall act in good faith in all things relating to
their engagement in this Agreement and all matters derived
therefrom.
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20.
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Force
Majeure
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20.1
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Notwithstanding
the aforesaid in this Agreement, a delay in the performance of an
obligation imposed on any Party due to an event which falls under the
definition of the term “Force Majeure” shall not be considered a breach of
the Agreement, and performance of the said obligation shall be deferred
until a date when the hindrance is removed, whereas the schedule will be
amended accordingly, unless the performance has become, due to the delay,
unreasonable under the circumstance of the
matter.
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20.2
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For
purposes of this Agreement, the term “Force Majeure” shall mean acts of
war, acts of terror, sabotage, general conscription, decisions of legal
tribunals (including injunctions, whether temporary or permanent), the
acts and omissions of an authority operating pursuant to law, statute,
strikes, state of emergency at the Hospital, and general stoppage of the
economy, natural disasters and other events that are not under the
reasonable control of the Party alleging the occurrence of the “Force
Majeure” event if that same Party alleging the occurrence of the said
“Force Majeure” event has taken all reasonable measures to prevent their
occurrence and/or continuance.
|
|
21.
|
Interpretation
|
|
|
21.1
|
Any
change or addition to this Agreement shall be made in writing and with the
signatures of all of the Parties affected by said change or addition
only.
|
|
|
21.2
|
In
the event it is determined that any provision of this Agreement - which
does not constitute a material and basic term herein - is invalid, illegal
or unenforceable, this will be insufficient to cause the avoidance of the
rest of the provisions of this Agreement and/or to affect the validity,
legality or the possibility of the enforcement of the rest of the
provisions, as stated.
|
|
|
21.3
|
This
Agreement shall replace any prior binder, representation, engagement,
arrangement or agreement between the parties, the subject matter of which
is the Trial, and voids them to the extent that they
exist.
|
|
22.
|
Notice and
Addresses
|
|
|
22.1
|
The
addresses of the Parties for purposes of this Agreement shall be:
-
|
The
Company – Misgav Business Par, ▇.▇. ▇▇▇ ▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇
The Fund
- ▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇-▇▇▇▇
The
Principal Investigator – at the Fund.
|
|
22.2
|
A
Party who shall change its address will submit notice of the same within a
reasonable time to the other
Parties.
|
|
|
22.3
|
A
notice that must be submitted pursuant to this Agreement will be delivered
to the Parties at the addresses specified above, by personal
delivery.
|
|
|
22.4
|
Any
notice submitted in accordance with this section shall be considered as if
delivered to its address after the passing of one business day from the
date on which receipt has been
confirmed.
|
In
witness whereof the parties set their hands
on
the date and at the location set forth above: -
|
/s/
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
|
/s/
Raz Tabib
Raz Tabib General Manager
Research & Development Fund
Tel-Aviv Sourasky Medical Center
Israel
|
/s/
▇▇▇▇▇
▇▇▇▇▇▇▇▇
▇▇▇▇▇
▇▇▇▇▇▇▇▇,
MD
Tel-Aviv Sourasky Medical Center
Israel
|
||
|
The
Company
|
|
The
Fund
|
|
The
Principal
Investigator
|
Appendix
A - Trial Protocol
Appendix
B - List of Trial Personnel
|
1.
|
▇▇.
▇▇▇▇▇ ▇▇▇▇▇▇ – Principle
Investigator
|
|
2.
|
▇▇.
▇▇▇ Tzarnin – sub Principle
Investigator
|
|
3.
|
▇▇▇▇.
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ – sub Principle
Investigator
|
|
4.
|
Ofer
Rap – Site Study Coordinator
|
Appendix
C - Trial Budget and Schedule of Payments
|
Ichilov
Budget
|
||||||||||||
|
Itemized per patient fees:
|
Quantity
|
ea.
|
Total
|
|||||||||
|
Sub
Investigator
|
1 | $ | 2,300 | $ | 2,300 | |||||||
|
Sub
Investigator
|
1 | $ | 1,725 | $ | 1,725 | |||||||
|
Sub
Investigator
|
1 | $ | 1,725 | $ | 1,725 | |||||||
|
Plastic
surgeon (per procedure)
|
2 | $ | 575 | $ | 1,150 | |||||||
|
Operating
room nurse (per procedure)
|
2 | $ | 173 | $ | 345 | |||||||
|
Per
Patient subtotal
|
$ | 7,245 | ||||||||||
|
Extended
follow-up - per month per patient
|
1 | $ | 575 | $ | 575 | |||||||
|
Screening
without enrollment (per patient)
|
1 | $ | 575 | $ | 575 | |||||||
|
Patient
reimbursement (estimated per patient)
|
$ | 2,000 | $ | 2,000 | ||||||||
Notes:
Central
lab (AML), travel expenses, shipments - are paid directly by Medgenics to the
subcontractors.
Patient
travel expenses will be paid to the taxi service directly by
Medgenics.
Payment
Terms:
|
|
1.
|
On
receipt of invoice, Net +30 days
|
|
|
2.
|
For
each patient recruited into the trial, the Company will be
invoiced:
|
|
|
a.
|
60%
at patient enrollment
|
|
|
b.
|
40%
at patient termination (or completion of 6 months of
follow-up)
|
|
|
c.
|
Extended
follow-up: invoiced on a quarterly
basis
|
|
|
d.
|
Patient
reimbursement will be charged to the Company without overhead, invoiced on
a quarterly basis
|