AGREEMENT Between BioCancell Therapeutics Ltd. Beck Science Center, 8 Hartom St. Jerusalem 97775, Israel (Hereinafter: “BioCancell”) And between Hadasit Medical Research Services and Development Ltd. Hadassah Ein-Kerem Hospital Jerusalem, Israel...
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AGREEMENT
Between
BioCancell
Therapeutics Ltd.
Xxxx
Science Center, 0 Xxxxxx Xx.
Xxxxxxxxx
00000, Xxxxxx
(Hereinafter:
“BioCancell”)
And
between
Hadasit
Medical Research Services and Development Ltd.
Hadassah
Xxx-Xxxxx Xxxxxxxx
X.X.Xxx
00000
Xxxxxxxxx,
Xxxxxx
(Hereinafter:
“the Medical
Center”)
BioCancell
and the Medical Center shall be hereinafter collectively referred to in this
Agreement as “Parties”; each one of which also referred to
as “Party”.
Whereas
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BioCancell
has expressed its interest in carrying out, managing and funding the
clinical trial the subject of which being “Phase 2b, Multicenter Trial of
Intravesical DTA-H19/PEI in Patients with Intermediate-Risk Superficial
Bladder Cancer”, bearing protocol no. BC-07-01, a copy of which is
attached as Appendix A hereto (hereinafter: “the Trial”); and
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Whereas
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The
Medical Center is a wholly owned subsidiary of Hadassah Medical
Organization (hereinafter: “HMO”) and is authorized
to enter this Agreement and to utilize HMO’s
facilities, employees and agents for the purpose of this Agreement;
and
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Whereas
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The
Medical Center wishes to conduct the Trial, and has declared that HMO
holds the proper facilities and staff required to perform the Trial, and
that it is willing to put such facilities and staff at the disposal of
BioCancell, for the purpose of performing the Trial;
and
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Whereas
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The
Parties agree that BioCancell shall maintain the management authorities
with regard to the performance of the Trial in all of its stages subject
to the Protocol, HMO internal procedures and Privacy limitations;
and
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Whereas
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BioCancell
has agreed to pay the Medical Center the consideration, specified in
Appendix C hereto, for the performance of all the undertakings of the
Medical Center under this Agreement; all, according to the terms and
conditions of this Agreement
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NOW, THEREFORE, it is hereby declared and
agreed between the parties as follows:
1.
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General
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1.1.
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The
preface and appendices to this Agreement constitute an integral part
hereof.
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1.2.
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Titles
of the sections in this Agreement shall be used for terms of reference
only, and could not be used for the interpretation of this
Agreement.
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1.3.
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This
Agreement contains the entire understanding of the Parties and the
Principle Investigator with respect to the subject matter hereof, and
supersedes all prior or pre-existing negotiations, declarations,
presentations, commitments and/or agreements, whether written or oral,
whether explicit or implied, between the Parties and the Principle
Investigator, with respect to such subject
matter.
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1.4.
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In
the event of a contradiction between this Agreement and any of the terms
of its appendices, the terms and conditions of this Agreement shall
prevail, whereas on medical issues, the Protocol (Appendix A) prevails
this Agreement.
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1.5.
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Anything
in this Agreement denoting the singular shall also denote the plural, and
anything denoting the feminine gender shall also denote the masculine
gender, and vice versa, insofar as no other meaning is inferred by the
context.
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2.
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Appendices
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The
appendices to the Agreement are:
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2.1.
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Appendix
A: The Trial Protocol
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2.2.
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Appendix
B: The Trial Personnel Clearance
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2.3.
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Appendix
C: The Consideration
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2.4.
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Appendix
D: Schedule 4 of the Guidelines.
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2.5.
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Appendix
E: The Trial Documents and Related
Activities.
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3.
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Definitions
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In this
Agreement, the following terms shall have the specific meaning attributed to
them in the table below:
The
Agreement
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This
agreement and its appendices.
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Serious
Adverse
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As
defined in the Trial
Protocol and in the Guidelines.
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Event
Monitors
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Any
body or person/s nominated by, or representing BioCancell and/or any
company of the BioCancell Group to monitor the Trial (i.e., conduct
on-site audits for Good Clinical Practices
compliance).
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Completed
CRF
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A
CRF having, according to the discretion of BioCancell and/or any third
party appointed by BioCancell, no discrepancies in its details and no
unanswered queries.
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CRF
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Case
Report Forms containing any and all data of the Subjects, which has been
gathered during the Trial. The CRF shall be in hardcopy
format.
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The End of the
Trial
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The
point in time, in which a Completed CRF has been submitted to BioCancell
by the Principal Investigator, as defined herein, for all the Subjects
participating in the Trial, or the date of termination of the Trial
according to the terms and conditions of the Agreement; the earlier of the
two.
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FDA
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The
United States of America Food and Drug Administration.
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The
Guidelines
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Ministry
of Health guidelines entitled “Clinical Trials of Human Subjects” as may
be amended and modified from time to time.
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The
Helsinki Declaration
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The
1964 Declaration of Helsinki regarding the recommendations guiding
physicians in bio-medical research involving human beings, as amended in
Tokyo, 1975.
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ICH-GCP
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Harmonized
Tripartite Guideline for Good Clinical Practice as may be amended and
modified from time to time.
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IND
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Investigational
New Drug Application (US code of Federal Regulations 21 CFR Part
312).
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Inspector/s
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Any
inspecting body legally authorized to perform inspections in clinical
trials, including, inter alia, the MOH, FDA or any other state regulated
medical authority.
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Invention
Rights
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(i)
Any and all intellectual property rights, relating to the Trial Data
and/or to the BioCancell Data, including, inter alia, all data, reports,
inventions, discoveries, formulas, concepts, tests, drawings,
specifications, applications, designs and trade secrets, methodologies,
engineering and manufacturing processes and research processes or results
generated, arrived at, developed or reduced to practice by the Medical
Center and/or the Principal Investigator during the course of, or arising
from the Trial, the right to register and/or own any inventions stemming
directly or indirectly from the Trial Data and/or the BioCancell Data,
with the exception of Trial Subjects personal and confidential medical
records and hospital records.
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(ii)
All patents, copyrights, know-how, trademarks, and other intellectual
property in and/or covering such data, reports, invention, discoveries and
results as referred to above.
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Investigator
Brochure
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A
document, which is submitted along with the Trial Protocol to the relevant
Helsinki Committee and FDA, and the content of which is outlined in the
GCP Guidelines.
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Medical
Center Helsinki Committee
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A
committee appointed pursuant to the National Health Regulations and whose
role is to approve any and all medical experiments on humans conducted by
the Medical Center.
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Ministry
of Health Approval
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Approval
from the Director General of the Ministry of Health, or whomever he/she
has delegated the authority to for this purpose, for the performance of
the Trial at the Medical Center, according to the National Health
Regulations and the Guidelines.
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Ministry
of Health / MOH
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The
Israeli Ministry of Health.
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National
Health Regulations
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Israel
National Health Regulations (Clinical Trials on Human Subjects), 1980 as
may be amended from time to time.
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Publications
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All
publications, manuscripts, abstracts and papers relating directly to the
Trial, and which were initiated or composed directly, in whole or in part,
by the Principal Investigator and/or by the Medical Center and/or by any
of the Trial Personnel.
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The
BioCancell Data
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Any
and all information provided by BioCancell or by the BioCancell Group to
the Medical Center, Principal Investigator or any member of the Trial
Personnel with regard to the Trial, including, without limitation, the
Trial Protocol and the Investigator Brochure which shall be the sole
property of the BioCancell Group.
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The
BioCancell Group
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The
group of companies consisting of BioCancell Therapeutics, Inc and
BioCancell Therapeutics Ltd.
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The
Guidelines
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Ministry
of Health guidelines entitled “Clinical Trials of Human Subjects” as may
be amended and modified from time to time.
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The
Product(s)
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DTA-H19/PEI
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The
Subjects
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A
group of persons chosen by the Principal Investigator to participate in
the Trial and who signed a written informed consent for the participation
in the Trial, all according to the criteria established in the Trial
Protocol.
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The
Trial Data
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Any
and all clinical data, technical information, records, files and materials
relating to the Trial, including the Trial Documents, case report forms,
source documents (such as subjects charts and physical notes), as well as
other related data generated during or as a result of the Trial which
shall be the sole property of the BioCancell Group, and be subject to
confidentiality obligations imposed under the Guidelines and ICH-GCP and
National Health Regulations.
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Trial
Documents
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Any
and all documents required by BioCancell, the MOH, the Medical Center or
any applicable laws, rules, regulations or guidelines, for the initiation,
performance and completion of the Trial; without derogating from the
generality of the above, the Trial Documents shall include any and all
documents specified in Appendix E to this Agreement subject to
confidentiality obligations imposed under the Guidelines and ICH-GCP and
National Health Regulations.
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Trial
Personnel
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The
medical and administrative staff involved in the Trial, including those
who shall be employed by HMO and cleared according to the undertaking
attached to this Agreement as Appendix B.
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The
Trial Protocol
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A
document that describes the objective(s), design, methodology, statistical
considerations, and organization of the Trial. The Trial Protocol usually
also gives the background and rationale for the trial, but these could be
provided in other protocol referenced documents. Throughout this Agreement
the term Trial Protocol refers to the protocol and its amendments, which
are attached to this Agreement as Appendix
A.
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4.
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Precedent
Conditions
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The
Parties hereby agree and undertake that the Agreement shall not enter into
effect before all of following cumulative approvals have been granted
(hereinafter: “the Approvals”):
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4.1.
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The
approval of the Trial Protocol by the Medical Center Helsinki Committee
and the MOH, if such approval is required by the Guidelines;
and
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4.2.
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The
approval of the Agreement in general, its budget and Appendix C in
particular, by the MOH and the committee of engagement with commercial
companies in accordance Section 9 of the Guidelines;
and
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4.3.
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The
approval of the Trial Protocol, Investigator Brochure and related
documents by the FDA.
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5.
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The
Principal Investigator
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5.1.
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Xx.
Xxxxxxxx Xxxxxx MD, of HMO (hereinafter: “the Principal
Investigator”) has agreed to
serve as the principal investigator of the
Trial.
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5.2.
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The
Principal Investigator undertakes to perform the Trial in compliance with
the following: (a) the Trial Protocol, (b) the Guidelines, (c) the
instructions and the terms specified in the approval of the Medical Center
Helsinki Committee, (d) the ICH-GCP, (e) the Helsinki Declaration, (f) the
applicable laws, rules and regulations regulating such studies which are
applicable in Israel, (g) written instructions and prescriptions issued by
BioCancell regarding the Trial and/or the Product; all as may be amended
from time to time, and (h) the requirements in accordance with the FDA
Form 1572 “Statement of Investigator.” Every PI at each site must sign
this form for submission to the
FDA.
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5.3.
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The
Principal Investigator has declared that he holds the professional ability
and credentials required for performing the Trial in accordance with the
Trial Protocol and any applicable laws, rules, regulations and guidelines,
all as detailed above.
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5.4.
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In
the event that the Principal Investigator, for any reason whatsoever,
shall be unable to conduct the Trial, or shall cease to be available for
the performance of the undertakings set forth in this Agreement, the
Medical Center shall use its best efforts to appoint, within 30 days of
the Investigator becoming unable to conduct the Trial, a suitably
qualified successor investigator whose identity shall be approved in
advance by BioCancell (the “Successor Investigator”). Such Successor Investigator
shall undertake all the duties and responsibilities of the Principal
Investigator as detailed in the Agreement. Should the Medical Center not
be able to appoint a Successor Investigator, or if the appointed Successor
Investigator is not acceptable by BioCancell, either party shall be
entitled to terminate this Agreement forthwith and without further
liability and at no cost to Biocancell, save for any payments for work
already performed and for documented out-of-pocket costs arising from
non-cancellable commitments incurred prior to such
termination.
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5.5.
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In
the event of the replacement of the Principal Investigator, as described
under this Section 5.4, the Principal Investigator shall have no claim
towards BioCancell and/or the Medical Center and/or any third party acting
on their behalf in direct or indirect connection with such
replacement.
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6.
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Medical
Center undertakings
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6.1.
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The
Medical Center represents that HMO has the requisite skills, knowledge,
experience, facilities, resources and appropriately qualified human
resources to undertake and conduct the Trial in accordance with the
provisions of this Agreement.
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6.2.
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The
Medical Center and HMO undertake that the Trial shall be conducted in an
efficient, diligent, professional and timely manner and in compliance with
the following: (a) the Trial Protocol, (b) the Guidelines, (c) the
instructions and the terms specified in the approval of the Medical Center
Helsinki Committee, (d) the ICH-GCP, (e) the Helsinki Declaration, (f) the
applicable laws, rules and regulations regulating such studies which are
applicable in Israel, and (g) written instructions and prescriptions
issued by BioCancell regarding the Trial and/or the Product; all as may be
amended from time to time.
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6.3.
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The
Medical Center and the Principal Investigator shall conduct the Trial and
maintain records and data during and after the term of this Agreement in
compliance with all applicable laws, rules, regulations and guidelines and
the requirements of any governmental authority regulating such
trials.
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6.4.
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The
Medical Center and HMO hereby undertake to furnish BioCancell, the
Principal Investigator and all of the Trial Personnel with the facilities
and personnel necessary for the adequate performance of the Trial
according to the terms and conditions of the Trial Protocol, and to fully
collaborate with the Principal Investigator, BioCancell, and/or any other
third party nominated by BioCancell, with regard to performing its duties
hereunder.
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7.
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BioCancell
Undertakings
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7.1.
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BioCancell
hereby undertakes to allow the Principal Investigator to use the BioCancell
Data, on a need-to-know basis, exclusively for the purpose of performing
the Trial, during the Term of This Agreement and according to the terms
and conditions of this
Agreement.
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The
Principal Investigator shall strictly abide by any and all instructions
given to him by BioCancell with regard to the BioCancell Data, while
recognizing that BioCancell or any other company from the BioCancell Group
was and shall remain, during the Term of this Agreement and thereafter,
the sole and exclusive owner of any and all rights in the BioCancell Data
and the Trial Data, and the use
thereof.
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7.2.
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BioCancell
shall remunerate the Medical Center, the Principal Investigator and the
Trial Personnel, according to the terms of Appendix C hereto, for all
services rendered.
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7.3.
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BioCancell
represents that it is the sole owner of any and all intellectual property
rights of the Product and that the execution and delivery of this
Agreement does not infringe any third parties rights and/or any
law.
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8.
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Parties
Mutual Undertakings
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8.1.
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The
Principal Investigator will be responsible for obtaining the written
informed consent of each of the Subjects, or his or her authorized legal
representative, before his or her participation in the Trial. The form of
the informed consent shall be drafted by BioCancell and approved by the
Principal Investigator.
Without
derogating from the generality of the foregoing, it is agreed that such
informed consent shall be obtained: (i) in circumstances in which the
prospective Subject (or his or her representative as aforesaid) is given
reasonable and sufficient opportunity to consider whether or not to
participate in the Trial and which minimize the possibility of coercion
and/or undue influence; and (ii) in compliance with all applicable laws,
regulations, standards and
guidelines.
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8.2.
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All
Parties to this Agreement undertake securing all individually identifiable
health information and keeping that information with the highest possible
degree of confidentiality and protection from disclosure. Accordingly, all
Subjects identifiable health information shall at all times be treated as
confidential by all parties involved in the execution of the Trial in
accordance with the Applicable Laws and any regulations and rules
promulgated subsequently. The Parties agree to take such additional steps
and/or to negotiate such amendments to this Agreement as may be required
to ensure compliance with any laws, the Guidelines and Regulations and any
rules promulgated subsequently. Any such amendment must be informed by
either Party to the other Party.
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8.3.
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Without
derogating from the aforesaid, the Investigator shall notify Biocancell at
the earliest possible time of any deviations from the Trial Protocol that
are necessary to protect the safety, rights or welfare of the
Subjects.
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8.4.
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It
is hereby agreed that any undertaking of the Medical Center and/or HMO and
its employees, including the Principal Investigator hereunder whatsoever,
is subject to any restrictions and/or limitations deemed necessary by the
Medical Center and/or HMO and its employees, including the Principal
Investigator in their sole discretion, to comply with the above
provisions. It is hereby made expressly clear that no Subjects’
identifiable information will be provided, or made available, to
BioCancell or any party acting on its behalf, without prior written
consent of the Subject.
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8.5.
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Nothing
contained in this Agreement shall be construed as a warranty by the
Medical Center and/or HMO and its employees, including the Principal
Investigator, that the results of the Trial will be useful or commercially
exploitable or of any value whatsoever. In addition, and without
derogating from the aforementioned the Medical Center and/or HMO and its
employees, including the Principal Investigator disclaim all warranties,
either express or implied, with respect to the Trial and any products,
including the Product, that incorporate, integrate or are designed based
in whole or part, on the Trial Data and Reports, 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 Trial Data, the Reports and the Product and any accompanying
materials remains solely with BioCancell, and BioCancell shall be solely
responsible for any use of the Trial Data, the Reports and/or the
Product.
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8.6.
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Nothing
contained herein shall be construed as casting upon the Medical Center
and/or HMO and its employees, including the Principal Investigator an
undertaking to purchase any equipment for purpose of the performing the
Trial or for improving its existing
equipment.
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9.
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Consideration
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9.1.
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In
consideration for the performance of all of the tasks, duties and
undertakings of the Principal Investigator, the Trial Personnel and the
Medical Center under this Agreement, BioCancell hereby undertakes to pay
the Medical Center the amount specified in Appendix C hereto, according to
the installments, timetable and manner specified therein. For the removal
of doubt, the consideration set out in Appendix C hereto constitutes the
only consideration payable by Biocancell under this Agreement for the
conduct of the Trial, with the exception of Indemnification or unless
defined otherwise in this
Agreement.
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9.2.
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If
Biocancell is required by applicable law to make any tax deduction, tax
withholding or similar payment from any amount paid or payable by
Biocancell on account of income tax, tax on profit or any other taxes of a
similar nature imposed on the Medical Center (“Withholding Tax”) under this Agreement, then
Biocancell shall notify the Medical Center of this requirement and shall
deduct the Withholding Tax from the payments referred to above, as
prescribed by applicable law and shall provide the Institution as soon as
practicable with the receipts or other documents issued by the tax
authorities evidencing payment of the Withholding Tax, so that the Medical
Center may claim an appropriate tax credit from the relevant tax
authorities. Alternatively, the Medical Center shall provide BioCancell
with the appropriate Tax Exemption at Source approvals from the relevant
tax authorities.
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10.
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Product
Supply
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10.1.
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BioCancell
will, at its own expense, supply to the Medical Center all necessary
quantities of the drugs to be used in the Trial, and only for the purposes
as described in the Protocol. Any surplus shall be returned to BioCancell,
at BioCancell expense, without delay, upon completion of the Trial or
termination of this Agreement for any reason whichever is the
earlier.
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10.2.
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The
Medical Center will ensure that the Product is managed and stored in
accordance with GCP and with any special instructions issued by
BioCancell. Any use of any drugs under the Trial, including the Product,
shall only be made via HMO’s
internal pharmacy and shall be subjected to its procedures. HMO internal
pharmacy and the Principal Investigator will maintain proper records of
receipts, dispensing and returns of the
Product.
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10.3.
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BioCancell
will continue to supply the Product after the termination of the Trial
and/or Agreement to the patients participating in the trial in accordance
with Appendix D.
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11.
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Trial
Personnel Compliance and Clearance
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11.1.
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The
Medical Center and the Principal Investigator hereby undertake to exercise
their best efforts so that the Trial Personnel shall abide by : (a) the
Trial Protocol, (b) the Guidelines, (c) the instructions and the terms
specified in the approval of the Medical Center Helsinki Committee, (d)
the ICH-GCP, (e) the Helsinki Declaration, (f) the applicable laws, rules
and regulations regulating such studies which are applicable in Israel,
and (g) written instructions and prescriptions issued by BioCancell
regarding the Trial and/or the Product; all as may be amended from time to
time.
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11.2.
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The
Trial will also be conducted in accordance with the “Statement of
Investigator” (FDA form no. 1572).
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11.3.
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Trial
Personal Clearance:
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11.3.1.
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The
Medical Center and the Principal Investigator shall deploy all possible
efforts that none of the Trial Personnel (including the Principal
Investigator and any other investigators) are debarred by the FDA or by
the MOH in any capacity whatsoever, and that (1) none of the Trial
Personnel appear in the FDA debarment list, detailing all firms or persons
debarred pursuant to Section 306 (a) and (b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335 (a) and (b)), as published in the Federal
Registrar from time to time; and (2) none of the Trial Personnel are
debarred according to the terms and conditions of the Israeli Physicians
Ordinance [New Version], 1976 or pursuant to any other applicable
law.
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11.3.2.
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The
Medical Center and the Principal Investigator shall provide BioCancell
with the written confirmation thereof, in a form attached as Appendix B
hereto.
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12.
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Compliance
with the Trial Budget and Cooperation with BioCancell
Sub-Contractors
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12.1.
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The
Medical Center and the Principal Investigator hereby undertake to perform
the Trial in accordance with the budget of the Trial, as such term is
derived from Appendix C hereto (hereinafter: “the Trial Budget”) and not to deviate therefrom without
the prior written approval of BioCancell in relation
thereto.
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12.2.
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The
Medical Center and the Principal Investigator hereby undertake to fully
cooperate with any and all sub-contractors nominated by BioCancell for the
purpose of the Trial, including, inter alia, clinical research
organizations, logistics companies, laboratories,
etc.
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13.
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Trial
Documents
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13.1.
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The
Principal Investigator shall prepare and submit the Trial
Documents.
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13.2.
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The
Principal Investigator shall perform all the activities specified in
Appendix E hereto.
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13.3.
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Any
and all amendments to the Trial Protocol shall be performed only after
securing the approval of BioCancell and the competent regulatory
authority. Insofar as permitted by applicable legislation, BioCancell is
entitled to alter or amend the Protocol and/ or other documents related to
the Trial, subject to prior written notice to the Principal Investigator
and the Medical Center of at least fourteen (14) days prior to such
amendment application to the Medical Center Helsinki Committee. The
Medical Center and the Principal Investigator shall act in accordance with
these alterations or amendments. BioCancell shall incur all costs and fees
levied by the Medical Center Helsinki Committee for the purpose of such
amendment of the Protocol.
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14.
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Confidentiality
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14.1.
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The
Parties and the Principal Investigator hereby agree and undertake that
they are aware that the BioCancell Data and the Trial Data (hereinafter,
jointly and severally “the Confidential
Information”) are
confidential information, and that BioCancell has disclosed such
Confidential Information to the Medical Center and Principal Investigator
for the sole purpose of conducting the
Trial.
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14.2.
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The
Parties and the Principal Investigator hereby agree and undertake that
they are aware that the Confidential Information is the sole and exclusive
property of BioCancell and/or any other company from the BioCancell Group.
Accordingly, The Principal Investigator shall retain the Confidential
Information under the strictest safeguarding and not use, disclose or
divulge the Confidential Information in part or in whole, directly or
indirectly, for a period of five (5)
years.
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|
14.3.
|
The
Medical Center and the Principal Investigator shall maintain the
confidentiality of the Confidential Information using the same degree of
care used by them in relation to their own confidential information, and
shall, without limitation, keep the Confidential Information in a safe and
separate place and not make any copies thereof (whether in hardcopy or
electronic file) unless first receiving BioCancell’s
prior written consent.
|
|
14.4.
|
The
Medical Center and the Principal Investigator hereby further undertake to
limit access to the Confidential Information to the Trial Personnel and
any third parties on a “need to know basis”
only.
|
|
14.5.
|
At
the request of BioCancell, the Medical Center and the Principal
Investigator shall forthwith return to BioCancell the Confidential
Information or any part thereof, in accordance with Section 13.3
above.
|
|
14.6.
|
The
Medical Center and the Principal Investigator hereby state that they are
aware of the fact that any unauthorized disclosure or use of the
Confidential Information shall cause immediate and/or irreparable injury
to BioCancell, and that BioCancell cannot be adequately compensated for
such injury in monetary damages. Thus, in order to safeguard BioCancell
from any possible breach of confidentiality, the Principal Investigator
and the Medical Center hereby undertake that BioCancell would be permitted
to obtain, from any Court or Tribunal, any temporary or permanent
injunction relief, necessary to prevent such unauthorized disclosure or
use or peril thereof, and hereby renounce filing and/or submitting any
objection to any request by BioCancell or by any company from the
BioCancell Group, relating to such temporary or permanent
injunction.
|
|
14.7.
|
For
the avoidance of any doubt, it is hereby clarified that such an
undertaking is supplementary to and will not prejudice any right or
remedy, which is or shall be available to BioCancell under any applicable
law or agreement.
|
|
14.8.
|
The
Medical Center and the Principal Investigator hereby undertake to exercise
their best efforts to see to it that the Trial Personnel shall abide by
the undertakings set forth in this Section
14.
|
|
14.9.
|
In
the event that the Medical Center and the Principal Investigator are
required by law, regulation, rule, act or order of any governmental
authority or agency to disclose Confidential Information, they shall be
entitled to do so provided that it shall reasonably attempt to first
notify BioCancell of any such required disclosure, and limit such
disclosure as far as is possible under applicable law. Such disclosure
shall, however, not relieve the Medical Center and the Principal
Investigator of their other obligations contained
herein.
|
15.
|
Invention
Rights
|
|
15.1.
|
The
Medical Center and the Principal Investigator hereby acknowledge that the
idea and initiative for the Trial were exclusively those of BioCancell,
and that the involvement of the Medical Center and the Principal
Investigator in the Trial is strictly the consequence of their nomination
by BioCancell.
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15.2.
|
The
Parties and the Principal Investigator hereby irrevocably agree and
undertake that the Confidential Information, except for medical records of
the Subjects and subject to Confidentiality, is the exclusive property of
BioCancell, may be freely utilized by BioCancell in any manner it sees
fit. Notwithstanding the above, BioCancell shall have the right to review
Subjects’
medical records, subject to the limitations stated in Section 8, to verify
entries in the CRF’s.
BioCancell hereby undertakes full responsibility to ensure the safekeeping
of patients’
confidentiality and personal data and shall be fully responsible for
taking every measure to apply this
commitment.
|
15.3.
|
The
Parties and the Principal Investigator hereby irrevocably agree and
undertake that the Invention Rights shall be the absolute and exclusive
property of BioCancell and that BioCancell shall have unrestricted free
right to use such Invention Rights.
|
15.4.
|
The
Medical Center and the Principal Investigator hereby undertake to disclose
to BioCancell any and all applicable information relating to Invention
Rights and exercise their best efforts with regards to registration of the
Inventions Rights on the name of BioCancell and/or a name designated in
writing by BioCancell, if and to the extent requested to do so by
BioCancell and at BioCancell’s
expense.
|
15.5.
|
If
by operation of law or for any reason, any Invention Rights to be owned by
BioCancell pursuant to this Section 15 are not automatically deemed
proprietary BioCancell upon their creation, the Medical Center and the
Principal Investigator hereby further undertake to cause the Trial
Personnel to, irrevocably grant and assign all such intellectual property
rights to BioCancell, at BioCancell expense in relation to filling and
submitting applications to the relevant
authorities.
|
15.6.
|
Nothing
contained herein shall be deemed to grant the Investigator and the Medical
Center a license to use BioCancells’
Invention Rights and IP for any purposes whatsoever except for the
performance of the Trial pursuant
hereto.
|
16.
|
Inspections
|
16.1.
|
The
Medical Center and the Principal Investigator hereby undertake to allow
the monitors to perform monitoring visits in all sites related to the
Trial subject to a prior reasonable notice and during HMO working hours
(Sunday-Thursday 8 a.m. to 4 p.m. with the exclusion of holidays) during
or after the Trial, and assist the monitors in their duties. For the
avoidance of doubt, it is hereby clarified that the monitors shall be
entitled to monitor and/or inspect among others the Trial Documents and
Trial Data as well as to insure compliance with the Trial Protocol,
subject to the confidentiality conditions set in this
Agreement.
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|
16.2.
|
The
Medical Center and the Principal Investigator hereby undertake to allow
the Inspectors to perform inspections of all sites related to the Trial,
during or after the Trial (and each such inspection shall hereinafter be
referred to as: “an
Inspection”) in order to
determine their adequacy, to examine all data, documents, records, work
product relating to the Trial, to validate case reports against original
data in its files and to make copies of such data, documents and records
and to monitor work preformed to the extent relevant or necessary to
ascertain compliance thereof with the Trial Protocol, applicable laws,
rules, regulations, guidelines and the terms of this Agreement. The
Medical Center and the Principal Investigator also undertake to assist the
Inspectors in their duties, if and to the extent requested to do so by the
Inspectors.
|
16.3.
|
The
Medical Center and the Principal Investigator shall immediately inform
BioCancell in the event of an Inspection and/or upon gaining knowledge of
any intention to perform an Inspection. The Medical Center and the
Principal Investigator shall provide BioCancell with copies of any
inquiries, correspondence or communications to or from any such
Inspectors.
|
16.4.
|
The
Medical Center and/or the Investigator shall promptly notify Biocancell in
writing if any regulatory authority schedules an inspection or, without
scheduling, commences an inspection as aforesaid and shall promptly
provide Biocancell with a copy of correspondence or observations made by
such regulatory authority relating to the Trial and/or resulting from any
such Inspection.
|
16.5.
|
The
Medical Center and the Investigator shall take any reasonable action
requested by BioCancell to cure deficiencies noted during an audit or
inspection.
|
17.
|
Publications
|
17.1.
|
BioCancell
covenants that it will not at any time, without first obtaining the
consent in writing of the Medical Center (which consent may by refused or
granted in its absolute discretion), use the Medical Center’s
name or the name of the Principal Investigator or otherwise disclose the
fact of their involvement in the performance of the Trial in any
advertising, publicity or publication. However, BioCancell may use the
name of the Medical Center and/or the Principal Investigator for listing
the Trail on xxxxxxxxxxxxxx.xxx.
which shall include merely a disclosure that shall be limited to the fact
that the Trial has been executed in HMO under the supervision of the
Principal Investigator. BioCancell shall include appropriate
acknowledgement and credit reflecting the contribution of the Principal
Investigator, HMO and the Trial Personnel in any publication relating to
the Trial in whatever media, in accordance with customary scientific
practice.
|
17.2.
|
Publication
of the Trial and/or its results, in whole or in part, shall be within the
sole and absolute discretion of BioCancell. The Medical Center, the
Principal Investigator or the Trial Personnel, and any employees and/or
officers and/or representatives of any of the foregoing shall not publish
or refer to the Trial and/or its results, in whole or in part, without
obtaining the prior consent of BioCancell in writing. BioCancell reserves
the right to reject any such request, at its sole discretion. For the
avoidance of doubt BioCancell has the right, at all times, to publish any
article or data generated from the services rendered under this Agreement.
Subject to the foregoing, following termination of the Trial, and in the
absence of any publication within a period of one calendar year, Principal
Investigator shall be entitled to make a publication providing notice to
BioCancell and suspending such publication for a period of thirty (30)
days in order to enable BioCancell to safeguard any Intellectual Property,
extendable for an additional period of thirty (30) days. After theses two
extensions, the Principal Investigator shall have the liberty to make such
publication.
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17.3.
|
Without
derogating from this Section 17, BioCancell hereby undertakes to abide by
the rules of publications issued by the MOH and set forth in Section 2 of
Appendix D attached hereto.
|
18.
|
Reports
|
18.1.
|
Each
of the Medical Center and the Investigator shall: (i) prepare and maintain
complete and accurate written records, accounts, notes, reports and data
of the Trial, including source data and case report forms (on case report
forms supplied by Biocancell) in accordance with the Trial Protocol and
applicable laws, regulations and guidelines (the “Reports”); and (ii) retain all such
Reports after completion of the Trial for such periods as determined by
any applicable law or regulation, but no less than 15 (fifteen) years, at
no additional cost to Biocancell. Upon termination of the retention
period, the Medical Center shall transfer all Reports to Biocancell,
subject to confidentiality obligation as stated under this Agreement or if
so requested by Biocancell, destroy such Reports. In no event shall any
such Reports be discarded or destroyed without first notifying Biocancell
and subject to BioCancell indication within thirty (30) days subsequent to
the aforesaid notification.
|
18.2.
|
The
Medical Center and the Principal Investigator hereby undertake to submit
the Reports to BioCancell and/or to competent authorities, whether Israeli
or foreign.
|
18.3.
|
The
Medical Center and the Principal Investigator hereby undertake to disclose
in the Reports any and all data provided to them by BioCancell, in
accordance with any applicable laws, rules, regulations and guidelines,
including, inter alia, safety data.
|
18.4.
|
The
Medical Center will cause the Principal Investigator to provide
BioCancell, within 45 (forty five) days of the end of each period of three
(3) months during the period of the Trial, with a written report on the
progress of the Trial in the said
period.
|
18.5.
|
45
(forty five) days following the End of the Trial, the Principal
Investigator shall submit to BioCancell a summary report, which shall
include, in a full and detailed manner, a declaration regarding the
activities performed during the Trial and the results obtained
therein.
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19.
|
Serious
Adverse Event
|
19.1.
|
In
the event one or more of the Subjects sustains any Serious Adverse Event
related to the Trial, the Principal Investigator shall inform BioCancell
and the Medical Center Helsinki Committee and/or the Medical Center
management and/or the authorized national health
authorities.
|
19.2.
|
The
Principal Investigator shall report such Serious Adverse Event in the
timetable and manner prescribed in the Trial Protocol and
Guidelines.
|
19.3.
|
In
the occurrence of a Serious Adverse Event the Principal Investigator and
the Medical Center Helsinki Committee shall be entitled to immediately
cease the performance of the Trial, pending a prior notice of at least 24
hours to BioCancell regarding such decision and its
execution.
|
19.4.
|
In
the occurrence of a Serious Adverse Event BioCancell will immediately take
all measures at their disposal to evaluate the risk to the Subjects and/or
other patients and will instruct the Principal Investigator which measures
to take with regard to that risk.
|
19.5.
|
BioCancell
has an obligation, as the trial sponsor, to notify each investigator,
including the Principal Investigator of any Serious Adverse Events that
are reported by any site during the trial that are submitted to the FDA in
a safety report. Each Principal Investigator is obligated to provide these
reports to the appropriate Helsinki
Committee.
|
20.
|
The
Legal Status of the Medical Center and the Principal
Investigator
|
20.1.
|
The
Parties and the Principal Investigator hereby agree that the relationship
between BioCancell, on one hand, and the Medical Center and the Principal
Investigator, on the other hand, are that of a client and an independent
contractor, with the Medical Center and the Principal Investigator lacking
any capacity whatsoever to legally bind BioCancell to a relationship of
employer-employee, principal-agent or any other legal relationship
differing from that of a client and an independent
contractor.
|
21.
|
Term
and Termination
|
21.1.
|
This
Agreement shall be in full force and effect as of the latter of either:
(a) the date of its execution by the last Party and (b) the date the
Approvals have been granted; and until the End of the Trial (and the
period in which this Agreement shall be in full force and effect shall be
referred to in this Agreement as “the Term of this
Agreement”).
|
21.2.
|
The
Parties may bring this Agreement to an early end at any time, in writing,
by prior notice of at least 30 (thirty) days, upon the occurrence of one
(or more) of the following events:
|
21.2.1.
|
The
MOH has voided its approval granted for the performance of the Trial or
has conditioned the approval by conditions which the Medical Center and/or
the Principal Investigator, as the case may be, have notified BioCancell
that they are unable to comply
with.
|
21.2.2.
|
The
FDA has placed the Trial on clinical
hold.
|
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21.2.3.
|
BioCancell
decides upon its sole and absolute discretion to bring the Trial to an
end. For the sake of good order, the Parties and the Principal
Investigator hereby state and undertake that they are aware, and agree,
that BioCancell is entitled to terminate this Agreement, upon its sole and
absolute discretion, at any moment whatsoever; and in this case no party
hereto shall have any claim whatsoever towards BioCancell and/or any other
company from the BioCancell Group with regard to such early
termination.
|
21.2.4.
|
A
Party and/or the Principal Investigator is found to be in breach of this
Agreement and does not cure such breach within a period of 30 (thirty)
days following receipt of a notice in writing from any of the other
Parties in relation thereto.
|
21.2.5.
|
A
Party and/or the Principal Investigator enter into bankruptcy or
liquidation proceedings or a receiver is appointed over part or all of
their assets, and such proceedings are not ceased within a period of 45
(forty five) days following receipt by such Party of a written notice in
relation thereto from any or all of the other
Parties.
|
21.3.
|
In
the event of termination of this Agreement the Parties and the Principal
Investigator
shall bring the Trial to an end as
follows:
|
21.3.1.
|
Any
and all Confidential Information and remaining supply of Product shall be
returned to BioCancell, as defined in Section 14
above.
|
21.3.2.
|
The
Parties and the Principal Investigator shall cooperate in swiftly
dispersing the Subjects and Trial Personnel, if the need arises, while
preserving the latest Trial Data and providing as many Completed CRF’s
as possible, and all to the satisfaction of
BioCancell.
|
21.3.3.
|
BioCancell
shall pay the Medical Center all out-of-pocket and none-cancelable
commitments incurred by the Medical Center prior to such
termination.
|
21.4.
|
The
obligation of the Parties and the Principal Investigator pursuant to
sections 14,
15, 17, and 22 shall survive termination of this
Agreement.
|
22.
|
Insurance
and Indemnification
|
22.1.
|
BioCancell
has agreed to insure, in accordance with the terms and conditions set
forth in Appendix D attached hereto, the Subjects, the Trial Personnel,
the Principal Investigator and the Medical Center. BioCancell shall
provide for a sufficient product liability and/or clinical trial insurance
cover and all the necessary documents which prove the evidence of cover of
the above-mentioned liability to the Medical Center. BioCancell 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), of at least the same
level of coverage for the whole period of the Trial, sufficient insurance
coverage for the Trial and for BioCancell’s
liabilities hereunder, which insurance coverage shall be satisfactory to
the Medical Center. BioCancell further undertakes that the Medical Center,
the Principal Investigator, HMO, and the Trial Personnel will be included
as co-insured in such insurance policy/ies. The insurance policy/ies shall
have a discovery period of seven (7) years. Thirty (30) days prior to the
each Insurance Certificate expiry date, BioCancell shall provide the
Investigator with a new certificate that meets the requirements
above.
|
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|
22.2.
|
BioCancell
has agreed to indemnify the Trial Personnel, HMO, the Principal
Investigator and/or the Medical Center according to the terms of
Sub-Section 22.3 below (hereinafter each of them shall also be referred to
as: the “Indemnitee”) for damages arising as a
direct result of their involvement in the performance of the Trial
(hereinafter: the “Damages”), provided that the damages are
not as a result of an expected side effect of the Products and subject to
the conditions detailed herein:
|
22.2.1.
|
The
Damages are not caused as a result of negligence or misconduct of the
Indemnitee to the extent that such damage was caused or increased by the
negligence or willful misconduct of an
Indemnitee;
|
22.2.2.
|
The
Indemnitee performed the Trial in accordance with the Trial Protocol
;
|
22.3.
|
Promptly
after receipt by the Indemnitee of a notice of the commencement of any
claim, action, suit, proceeding or investigation in respect of which
indemnity may be sought pursuant to this Section 22 (hereinafter: the
“Claim”), the Indemnitee shall provide
a notice to BioCancell, in writing, describing in reasonable detail the
facts and circumstances upon which the asserted Claim for indemnification
is based, and shall thereafter keep BioCancell reasonably informed with
respect thereto. BioCancell shall have the right to assume the defense of
any Claim, at its sole discretion within the specified period of time
under law. In any event, the Indemnitee shall cooperate with BioCancell in
the defense of any Claim for which BioCancell assumes the defense of
behalf of all Parties, including the Principal Investigator and Trial
Personnel. BioCancell shall not be liable for the settlement by the
Indemnitee of any Claim affected without the consent of BioCancell.
BioCancell shall be entitled to enter into any settlement of a Claim at
its sole discretion. BioCancell may not assume the blame or liability of
the Medical Center, Trial Personnel or the PI without their prior written
consent.
|
23.
|
Limitation
of Liability
|
23.1.
|
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 connection to this Agreement even if such party is
advised of the possibility of such
damages.
|
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xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
23.2.
|
Without
derogating from the above, and except in the event of medical malpractice
to the Subjects, if the Medical Center or the Principal Investigator or
the Trial Personnel are found liable (whether under contract, tort
(including negligence) or otherwise), then the cumulative liability
thereof for all claims whatsoever related to the Trial or the Product or
otherwise arising out of this Agreement, shall not exceed a total
consideration actually paid to it under this Agreement. This limitation of
liability is intended to apply to all claims of BioCancell without regard
to which other provisions of this Agreement have been breached or have
proved ineffective.
|
24.
|
Notices
|
24.1.
|
Notices
to be given by one Party to another shall be in the English language, and
shall be deemed properly given if reduced to writing and transmitted to
the Party’s
address appearing on the first page of this Agreement, by air courier or
by certified registered mail - all to be effective 3 (three) days after
their sending date, or by facsimile with confirmation receipt - to be
effective at the first business day following the date of transmission,
provided that submission has been on a working day at HMO (Sunday-Thursday
8 a.m. to 4 p.m. with the exclusion of holidays) and acceptance shall be
construed as te subsequent working
day.
|
24.2.
|
However,
a notice shall be considered properly given, only in case a copy thereof
was communicated as follows:
|
Notice
to BioCancell
|
Notice
to Medical Center
|
BioCancell
Therapeutics Ltd.
|
Hadasit
Medical Research Services
|
Xxxx
Science Center, 8 Hartom St.
|
and
Development Ltd.
|
Jerusalem,
00000 Xxxxxx
|
Kiryat
Hadassah
|
Attn:
Ran Xxxxxx
|
X.X.Xxx
12000
|
Director,
Strategic Alliances
|
Xxxxxxxxx
00000
|
Telephone: x000-0-000-0000
|
Attn:_Mrs.
Xxxxxx Xxxxxxxx
|
Facsimile: x000-0-000-0000
|
VP
Finance & Contracts
|
Telephone:
x000-0-0000000
|
|
Facsimile:
x000-0-0000000
|
24.3.
|
The
addresses of the Parties, listed in page 1 of this Agreement, shall be
subject to any change of such address notified in writing by one Party to
the other, according to the procedure stipulated in this
Section.
|
25.
|
Miscellanies
|
25.1.
|
Expenses
of the Parties. Each Party and the Principal Investigator shall bear all
its own expenses, including the expenses of its attorneys, in connection
with the negotiation, execution and performance of this
Agreement.
|
25.2.
|
Waiver
and forbearance. No rights of any Party shall be prejudiced or restricted
by any indulgence or forbearance, to any other person or entity, and no
waiver by any Party in respect of any breach shall operate as a waiver in
respect of any subsequent breach.
|
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xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
25.3.
|
Governing
law and jurisdiction. This Agreement shall be exclusively governed by the
Laws of the State of Israel. Any and all disputes arising hereunder shall
be resolved by a competent court having jurisdiction over such matters in
the Jerusalem District, Israel
|
25.4.
|
Assignment.
This Agreement shall not be assigned, without the prior written consent of
all of the other Parties, save for an assignment of rights by BioCancell
to any company within the BioCancell Group and subject to the assignee
assuming all BioCancell obligations under this
Agreement.
|
25.5.
|
Counterparts.
This Agreement and any amendment hereto may be executed in multiple
counterparts, each of which shall be deemed an original agreement and all
of which shall constitute one and the same
agreement.
|
25.6.
|
Amendments.
Modification or amendment to this Agreement shall only be valid if
performed by a written instrument, signed by all Parties to this
Agreement.
|
25.7.
|
Severability.
If any provision of this Agreement is determined by a court of competent
jurisdiction to be invalid, illegal, or unenforceable, that determination
shall not affect any other provision of this Agreement, and each such
other provision shall be construed and enforced as if the invalid,
illegal, or unenforceable provision were not contained
herein.
|
[Remainder
of page left intentionally blank. Signature page follows.]
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|
IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed and each of the undersigned hereby warrants and represents that he or
she has been and is, on the date of this Agreement, duly authorized by all
necessary and appropriate action to execute this Agreement.
IN
WITNESS WHEREOF, the parties have executed this Agreement as at the date first
above written:
BioCancell
Therapeutics Ltd.
|
Hadasit
Medical Research Services
and
Development Ltd.
|
|||
By:
|
/s/ Xxx Xxxxx |
By:
|
[Illegible] | |
|
||||
Print
Name: Xxx Xxxxx
|
Print Name:
|
[Illegible] | ||
Title:
CEO
|
Title:
|
|||
By:
|
/s/ Xxxxxxxx Xxxxx |
By:
|
||
Print
Name: Xxxxxxxx Xxxxx
|
Print Name:
|
|||
Title:_VP
Clinical Development
|
Title:
|
I the
undersigned, Xx. Xxxxxxxx Xxxxxx MD, hereby declare and confirm that I have read
and understood the Agreement. I hereby agree to be appointed as the Principal
Investigator of the Trial on behalf of the Medical Center, and accept and
undertake to comply with all the terms, conditions, provisions, instructions and
stipulations set forth in the Agreement, including, without limitation,
provisions referring to the Parties.
/s/
Xxxxxxxx Xxxxxx
|
The
Principal Investigator
|
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|
Appendix
A
The Trial
Protocol
See
attached separately
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|
Appendix
B
The Trial Personnel
Clearance
An Undertaking with regard
to a Clinical Trial’s
Personnel
We, the
undersigned, hereby warrant and undertake in relation of clinical trial bearing
protocol number BC-07-01, researching “Phase 2b, Multicenter Trial of
Intravesical DTA-H19/PEI in Patients with Intermediate-Risk Superficial Bladder
Cancer”, that we have not, we do not and we will not use nor employ, in any
capacity, the services of any person debarred under Section 306 (a) or (b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335 (a) and (b)), or
debarred under the Israeli Physicians Ordinance [New Version], 1976 or pursuant
to any other applicable law.
The
Principal Investigator
|
The
Medical
Center
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
Appendix
C
The
Consideration
1.
|
Terms
and Definitions
|
In this
Appendix C terms shall have the meaning
assigned to them in the Agreement. The following terms shall have the meanings
assigned to them hereunder:
Complete
Screening
|
A
Screening of a Subject in which all examinations and/or tests and/or
treatment and/or evaluations included in the Screening process, as
detailed in the Trial Protocol, have been performed and the data collected
and registered in the CRF
|
|
Complete
Evaluation Visit or Complete Treatment Visit
|
A
Visit of a Participating Subject in which all examinations and/or tests
and/or treatment and/or evaluations scheduled for the visit have been
performed, as detailed in the Trial Protocol, and the data collected and
registered in the CRF
|
|
Evaluation
Visit
|
Any
Visit, as defined below, of visits 7, 11, 15, and 19 as these visits are
numbered and defined in the Trial Protocol.
|
|
Participating
Subject
|
A
Subject who that has undergone Screening, as defined below, and was
determined to meet the requirements specified in the Trial protocol and
who is participating in the Trial according to the terms and conditions of
the Trial Protocol
|
|
Screening
|
A
series of tests and examinations as defined in table 4 of the Trial
Protocol designed to evaluate a Subject’s suitability for participating in
the Trial, as detailed in the Trial Protocol.
|
|
Treatment
Visit
|
Any
Visit, as defined below, of visits 1-6, 8-10, 12-14, and 16-18 as these
visits are numbered and defined in the Trial Protocol.
|
|
Visit
|
Any
one of the scheduled nineteen (19) visits of a Participating Subject
as detailed in table 4 and 5 of the Trial
Protocol.
|
2.
|
The
Consideration
|
2.1.
|
In
consideration for the performance, in good faith, by the Principal
Investigator and
the Medical Center, of all of their undertakings under this Agreement,
BioCancell
hereby undertakes to pay to the Medical Center the following amounts:
|
Visit
#
|
Procedure
|
Costs
of
procedure (NIS)
|
Total costs
per visit
|
|||
Screening
|
Urine
cytology
|
140
|
||||
Video
cystoscopy
|
370
|
|||||
Histology
& Pathology
|
180
|
|||||
Doctor’s
fee
|
1,000
|
|||||
Study
nurse
|
250
|
|||||
Study
coordinator
|
250
|
|||||
TUR
|
960
|
3,150
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
Visit # 1 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit # 2 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 3
|
||||||
Doctor’s
fee
|
750
|
|||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 4
|
||||||
Doctor’s
fee
|
750
|
|||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 5
|
||||||
Doctor’s
fee
|
750
|
|||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 6
|
||||||
Doctor’s
fee
|
750
|
|||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 7
|
Urine
cytology
|
140
|
||||
Video
cystoscopy
|
370
|
|||||
Histology
& Pathology
|
180
|
|||||
Doctor’s
fee
|
500
|
|||||
Study
nurse
|
250
|
|||||
Study
coordinator
|
250
|
|||||
TUR
|
960
|
2,650
|
||||
Total
per first treatment period
|
13,300
|
|||||
Visit
# 8
|
||||||
Doctor’s
fee
|
750
|
|||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 9
|
||||||
Doctor’s
fee
|
750
|
|||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
Visit # 10 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 11
|
Urine
cytology
|
140
|
||||
Video
cystoscopy
|
370
|
|||||
Doctor’s
fee
|
500
|
|||||
Study
nurse
|
250
|
|||||
Study
coordinator
|
250
|
1,510
|
||||
Visit # 12 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit # 13 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit # 14 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit
# 15
|
Urine
cytology
|
140
|
||||
Video
cystoscopy
|
370
|
|||||
Doctor’s
fee
|
500
|
|||||
Study
nurse
|
250
|
|||||
Study
coordinator
|
250
|
1,510
|
||||
Visit # 16 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit # 17 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
||||
Visit # 18 | ||||||
|
Doctor’s
fee
|
750
|
||||
Study
nurse (Drug administration &
|
250
|
|||||
blood
sampling)
|
||||||
Study
coordinator
|
250
|
1,250
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
Visit
# 19
|
Urine
cytology
|
140
|
||||
Video
cystoscopy
|
370
|
|||||
Doctor’s
fee
|
500
|
|||||
Study
nurse
|
250
|
|||||
Study
coordinator
|
250
|
1,510
|
||||
Total
per continued treatment period (if no recurrence)
|
15,780
|
|||||
Total
per first treatment period & continued treatment
period
|
13,300
+
15,780
|
29,080
|
||||
General
|
Unscheduled
Histology & Pathology (if applicable)
|
180
|
180
|
|||
General
|
Unscheduled
Video cystoscopy
|
370
|
370
|
|||
General
|
Unscheduled
TUR
|
960 |
960
|
|||
Pharmacy
|
500
US $
|
500
US
$
|
* Blood
work and Urine analysis will be perform by an external central Lab (the costs
will be covered by the sponsor).
3.
|
Limitation
of Payments
|
|
3.1.
|
For
the avoidance of doubt, it is hereby declared and agreed that BioCancell
shall not pay any additional payments or any other amounts, which are not
clearly mentioned and specified in section 2
above.
|
3.2.
|
It
is further clarified that the amounts specified in section 2 above include
payment by BioCancell for all services rendered from the Medical Center
including but not limited to office services, Trial Personal required for
performing the Trial including the Principal Investigator, physicians,
nurses, receptionists and study coordinator, use of the Medical Center’s
facilities, and all tests, procedures, examinations and evaluations as
detailed in the Trial protocol.
|
|
3.3.
|
The
considerations do not include cost of analysis of hematology and chemistry
samples which will be performed by BioCancell’s
sub-contractor/s.
|
4.
|
Terms
of Payment
|
4.1.
|
The
Medical Center shall send an invoice at the end of each calendar quarter
(31/3, 30/6, 30/9, and 31/12) detailing the Complete Screening, Complete
Treatment Visits and Complete Evaluation Visits (together hereinafter:
“Complete Visits”)
performed as well as on which Subjects or Participating Subjects
the relevant Complete Visit was
performed.
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
4.2.
|
Payments
detailed in section 2 shall be conditioned upon payment for Complete
Visits and shall be included in the first invoice sent by the Medical
Center.
|
4.3.
|
Payment
shall be made by BioCancell within 30 (thirty)
days of receipt of the Medical Center’s
invoice.
|
4.4.
|
Immediately
upon receiving the payment as per the issued invoice the Medical Center
will provide BioCancell with a receipt approving the
payment.
|
5.
|
Currency of
Payments
|
All of
the payments subject of this Appendix C shall be performed by BioCancell to the
Medical Center in NIS (New Israel Shekel) and shall be subject to VAT, if
applicable.
6.
|
General
Observations and Clarifications
|
For the
sake of good order it is hereby clarified that, unless otherwise agreed upon in
writing by BioCancell:
6.1.
|
No
payment would be performed for any activities performed by the Principal
Investigator and/or by the Medical Center, prior to
the commencement of the Trial.
|
6.2.
|
Without
derogating from any right of BioCancell, in the event that no Completed
CRF’s are provided to BioCancell, regarding a Subject, in relation to
which BioCancell has performed payments to the Medical Center, BioCancell
shall be entitled to perform one of the following
three,:
|
6.2.1.
|
Write-off
the amount paid by BioCancell in relation to
Subject(s) for which no Completed CRFs have been provided (hereinafter:
“the Return Amount”)
from the amount remaining due to the Medical Center by BioCancell according to this
Agreement (hereinafter: “the Remaining
Amount”).
|
6.2.2.
|
Order
the Medical Center, in writing, to pay BioCancell the Return Amount
within a period no longer than 45 (forty-five) days from the End of the
Trial. The Medical Center hereby undertakes that it shall pay the Return
Amount, as specified above, and renounces any contentions and/or claims
whatsoever in relation
thereto.
|
6.2.3.
|
In
the event that the Return Amount shall exceed the Remaining Amount,
BioCancell shall be entitled to exercise its rights under the above
sub-sections 6.2.1 and 6.2.2 in concert, to the extent that BioCancell
shall fully collect the Return Amount from the Medical
Center.
|
6.3.
|
No
advance payments would be performed by BioCancell to the Medical
Center.
|
6.4.
|
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 shall bear the maximum interest charged by Bank
Leumi Le Israel B.M. for unapproved
overdrafts.
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
Appendix D
Schedule
4 of the
Guidelines
Title
of the trial: “Phase 2b, Multicenter Trial of Intravesical DTA-HI9/PEI in
Patients with
Intermediate-Risk Superficial Bladder Cancer”
|
|
The
protocol name and number: BC-07-01
|
|
Name
of the investigational product: DTA-HI9/PEI
|
|
Name
of the Principal Investigator:
|
Department:
|
Urology
|
|
Name
of the medical institution:
|
|
The
Sponsor’s
name and address: BioCancell Therapeutics Ltd., Xxxx Science Center, 0
Xxxxxx Xx., Xxxxxxxxx 00000,
Xxxxxx
|
1.
|
Sponsor
undertaking
|
The
Sponsor undertakes to act in accordance with the local and international law for
clinical trials, and in particular with regard to the following
issues:
1.1.1.
|
Responsibility
for the safety and good order of the investigational
product;
|
1.1.2.
|
Supply
of information regarding the trial;
|
1.1.3.
|
Notice
to the Ministry of Health regarding the performance of a multicentre
trial in Israel;
|
1.1.4.
|
Monitoring
the trial process;
|
1.1.5.
|
Safety
reports;
|
1.1.6.
|
Accountability
in respect of the investigational product;
|
|
1.1.7.
|
Retention
of documents.
|
2.
|
The
Sponsor undertakes that if it shall decide to publish the results of the
clinical trial in scientific literature, it shall publish them in full and
without taking matters out of their
context.
|
3.
|
Insurance:
|
3.1.
|
The
Sponsor undertakes to insure its legal liability pursuant to the laws of
the State of Israel against claims that may be filed by subjects in the
clinical trial and/or third party claims - all in connection with the
clinical trial, whether in the period of conducting the clinical trial or
thereafter. The insurance shall be extended to include the legal liability
of the medical institution and/or the clinical trial personnel and/or the
Principal Investigator (hereinafter referred to as “the
parties conducting the trial”) deriving from their involvement in the
conduct of the clinical trial, subject to an exception of an act committed
negligently or an intentional deviation from the clinical trial
protocol.
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
3.2.
|
The
Sponsor shall be given notice of any claim or any potential claim
immediately after such comes to the knowledge of the medical institution
or the Principal Investigator.
|
3.3.
|
The
Principal Investigator, the medical institution and its employees shall
give the Sponsor, upon its written request, reasonable support in any
event of a claim that may be filed against it as
aforesaid.
|
4.
|
The
Sponsor undertakes to supply the medical institution with the
investigational product throughout the period of the clinical trial until
the conclusion thereof, free of charge. Furthermore, the Sponsor
undertakes to pay all additional costs deriving from the conduct of the
clinical trial, provided that such costs do not derive from the regular
medical treatment of the sickness.
|
5.
|
If
after the termination of the clinical trial it is ascertained and
recommended by the Principal Investigator that the welfare of the patient
participating in the clinical trial necessitates continuation of his
treatment with the investigational product and there is no other
appropriate alternative medical treatment, the Sponsor undertakes to also
continue supplying the investigational product, without charge, after the
termination of the clinical trial for a period of three years, except in
one of the following cases:
|
5.1.
|
The
investigational product was approved for marketing in the State of Israel
after its registration for its requested scope and it can be obtained from
the sick fund with which the patient is
insured.
|
5.2.
|
The
development of the product was discontinued or the results of the clinical
trials were unsuccessful.
|
5.3.
|
The
administration of the investigational product for the said protracted
period is likely to harm the patient’s
health, since there is insufficient information regarding the safety of
the product administered over the long
term.
|
5.4.
|
Where
the investigational product is not a medical preparation, such as:
cosmetic products / food / food additive / herbal
remedy.
|
The
decision as to the continuation of administering the investigational product is
given to the medical institution’s Helsinki Committee (“the Helsinki Committee”), that is entitled to re-examine its
determination from time to time. The Principal Investigator and the Sponsor have
a right of appeal against such decision to the Ministry of Health’s
director-general or such person as empowered by him in such regard.
6.
|
The
continued administration of the investigational product after termination
of the clinical trial is subject to the following terms and
conditions:
|
6.1.
|
The
continued treatment shall be given within the context of an orderly
monitoring protocol that shall be written by the Principal Investigator
and approved by the Sponsor and the Helsinki
Committee.
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
6.2.
|
The
Principal Investigator is responsible for continuing to routinely monitor
the subject’s
medical condition and to report to the Helsinki Committee any exceptional
events that occur during the ongoing treatment, as is the norm in clinical
trials.
|
The
principal investigator shall report to the Helsinki Committee at least once a
year as to the progress of the subject’s
treatment.
The
medical institution in which the ongoing treatment shall be given shall attend
to appropriate insurance cover for the liability of the medical institution and
the Principal Investigator vis-a-vis the patient, in respect of the continuation
of administering the investigational product after the termination of the
clinical trial.
7.
|
This
Appendix constitutes an integral part of the agreement between the company
sponsoring the clinical trial and the medical
institution.
|
BioCancell
Therapeutics Ltd.
|
Hadasit
Medical Research Services
and
Development Ltd.
|
|||
By:
|
/s/ Xxx Xxxxx |
By:
|
[Illegible] | |
Print
Name: Xxx Xxxxx
|
Print Name:
|
[Illegible] | ||
Title:
CEO
|
Title:
|
|||
By:
|
/s/ Xxxxxxxx Xxxxx |
By:
|
||
Print
Name: Xxxxxxxx Xxxxx
|
Print Name:
|
|||
Title:
VP Clinical Development
|
Title:
|
I the
undersigned, Xx. Xxxxxxxx Xxxxxx MD, hereby declare and confirm that I have read
and understood this Appendix D.
/s/ Xxxxxxxx Xxxxxx |
The
Principal Investigator
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
Appendix
E
The Trial Documents and
Related Activities
The Trial
Documents shall include, inter alia, all the documents set forth in the
Guidelines, as well as the documents specified hereunder.
Any and
all terms not specifically defined in this Appendix shall have the meaning
attributed to them in the Agreement.
Prior
to the initiation of the Trial:
1.
|
The
executed signature page of the Trial Protocol;
and
|
2.
|
Investigator
Brochure; and
|
3.
|
The
current curriculum vitae of the Principal Investigator;
and
|
4.
|
The
list of all sub-investigators, all of which necessarily being listed on
either the FDA form no. 1572, or on the Principal Investigator’s Statement
Form; and
|
5.
|
The
written approval of the Medical Center Helsinki Committee, indicating that
it has reviewed and approved the Trial Protocol;
and
|
6.
|
The
written approval of the MOH with regards to the content of all publicity
and advertisements,
related to the Trial, which are to be performed prior to
the commencement
of the Trial; and
|
7.
|
A
list of all participants in the Helsinki Committee, convened in relation
to the Trial
(hereinafter:
“the Helsinki
Committee”);
and
|
7.1.
|
Should
the Principal Investigator be a member of the Helsinki Committee,
the written
Statement of the chairman of the Helsinki Committee confirming
that the
Principal Investigator did not participate in the voting, relating to the
Trial, during
the hearing of the said Helsinki Committee;
and
|
7.2.
|
A
financial disclosure form, confirming that the Principal Investigator
holds no financial
interests in BioCancell.
|
While
conducting the Trial:
1.
|
A
review of all the Trial Documents and verification the accuracy and
completeness thereof in relation to the source documents, on which the
above documents were based; and
|
2.
|
Report
to the Medical Center Helsinki Committee of any Severe Adverse Events, as
such terms are defined in the Trial Protocol, to the Subject(s), in
accordance with the Guidelines; and
|
3.
|
Report
to the Medical Center Helsinki Committee of any deviation from the Trial
Protocol; and
|
4.
|
Maintain
adequate records of Subjects identification, clinical observations, as
well as study drug receipt and dispensation (hereinafter: “the Records”), in accordance with any applicable
laws, rules, regulations and guidelines, as amended from time to time. In
any event, the Principal Investigator and BioCancell shall maintain the
Records for a period of no less than 15 (fifteen) years following the end
of the Trial.
|
Hadassah–agreement
0
Xxxxxx Xx, Xxxxxxxxx Xxxxxx 00000
Phone:
x000-0-000-0000 Fax: x000-0-000-0000
xxx.xxxxxxxxxx.xxx xxxx@xxxxxxxxxx.xxx
|
5.
|
Compare
the data in the CRF with the source documents relating to each subject
participating in the Trial, and confirm the accuracy of the CRF;
and
|
6.
|
Maintain
a log, documenting the Product(s) provided to each subject during the
Trial; and
|
7.
|
Report
no later than 7 (seven) days before additional quantities of Product(s)
are required to proceed with the
Trial.
|
8.
|
Complete
all CRFs
|
9.
|
Re-validate
the approval of the relevant Helsinki Committee to the Trial, within a
reasonable time prior to its expiration
date.
|
10.
|
A
written detailed periodic report on the progress of the Trial in the said
period (section 17.3 of the
Agreement).
|
At
the end of the Trial:
1.
|
All
Completed CRFs;
|
2.
|
A
summary report, which shall include, in a full and detailed manner, a
declaration regarding the activities performed during the Trial and the
results obtained therein (section 17.4 of the
Agreement).
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Hadassah–agreement