Exhibit 10.83
RESEARCH AGREEMENT
MADE AND ENTERED THIS 19 DAY OF NOVEMBER 2002 BY AND BETWEEN ADVANCED VIRAL
RESEARCH CORPORATION INC. WHOSE ADDRESS IS 200 CORPORATE BOULEVARD SO., YONKERS,
NY 10701 USA (HEREINAFTER: "THE COMPANY") AND KAPLAN MEDICAL CENTER (MEDICAL
RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND) WHOSE ADDRESS IS,
P.O. BOX 1, REHOVOT 76100, ISRAEL (HEREINAFTER: "THE FUND")
WHEREAS: The Company wishes to carry out a study of a Phase I/I Trial of the
Peptide Nucleic Acid Complex Product R in Patients with Advanced-Stage
Acquired Imminodeficiency Syndrome Study (hereinafter: "THE STUDY") in
accordance with the Study Protocol (hereinafter: "THE STUDY PROTOCOL")
dated March 10, 2002 attached to this Agreement as Schedule A and
constituting an integral part thereof; AND
WHEREAS: The Fund, through the services of Prof. Zev M. Shtoeger (hereinafter:
"THE INVESTIGATOR") of the Kaplan Medical Center (hereinafter: "THE
HOSPITAL") agrees to carry out the study on behalf of the Company; AND
WHEREAS: The parties to this Agreement agree to comply with the terms specified
in the appendix to the Guidelines of the Ministry of Health Committee
for Research Contracts with Commercial Companies No. 15/98 dated
16/11/98 titled "Obligations of the Commercial Company" attached to
this agreement as SCHEDULE B and constituting an integral part thereof
(hereinafter: "THE MINISTRY GUIDELINES");
WHEREAS: The Company, the Fund, the Hospital and the Investigator all
acknowledge and accept the fact that a principal purpose of the Study
is to produce results for submission to the U.S.F.D.A. in support of a
new drug application for a New Drug Approval (NDA) from said U.S.F.D.A.
and for that reason, the study must be performed in compliance with all
relevant laws and regulations of the U.S. and of the State of Israel.
NOW, THEREFOR. IT IS AGREED AND STIPULATED BETWEEN THE PARTIES AS FOLLOWS:
1. THE PREAMBLE
1.1. The Preamble to this Research Agreement and all its addenda
constitute an integral part thereof.
1.2. It is a condition precedent to the validity of this Research
Agreement that this Agreement shall come into effect only
after approval is received from the Helsinki Committee and the
Ministry of Health Committee for Research Contracts with
Commercial Companies.
2. THE STUDY
2.1. The Fund undertakes to perform the Study, using the services
of the Investigator, in accordance with the Study Protocol,
the Ministry of Health instructions, the terms specified in
the approval of the Helsinki Committee, current good clinical
practice and the statutes and regulations of the State of
Israel including its Ministry of Health and of the United
States including its Food and Drug Administration (FDA).
Should any contradiction arise between the above, the
instructions of the Ministry of Health and the tents specified
in the approval of the Helsinki Committee will prevail.
Whenever applicable, the Study will be performed only after
approval of the Study Protocol by the Helsinki Committee.
2.2. The Fund will conduct the Study in accordance with Section 2.1
above and according to all written instructions and
prescriptions issued by the Company and governing the
administration of the Study's drug. All Study drugs and
medicaments will be supplied by the Company at its sole
expense. The Fund shall maintain proper records concerning the
administration of the Study's drug.
2.3. The Study will be conducted in a manner required of a
reasonable and prudent clinical investigator or physician.
2.4. In the course of the Study, the Fund will also comply with the
Biomedical Research Manual which is applicable in Israel.
3. REPORTS AND PUBLICATIONS
3.1. The Fund agrees to permit representatives of the Company to
examine its facilities in order to determine their adequacy,
validate case reports against original data in its files and
monitor work performed to insure its compliance with the Study
Protocol and the relevant guidelines stipulated in the
Biomedical Research Manual. All Company's activities will be
conducted at reasonable times and in a reasonable manner.
3.2. Publication of the Study results in scientific literature is
encouraged, but the Company reserves the right to review any
paper written utilizing data generated from the Study before
such paper is presented or submitted for publication and to
stay publication for at least six (6) months in its
discretion.
3.3. The Company undertakes to comply with the terms concerning
publications, which are specified in paragraphs 1-- 5 to the
Ministry Guidelines (Schedule B).
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4. CONFIDENTIALITY AND PROPRIETARY RIGHTS
4.1. All information designated by the Company as confidential and
obtained by the Fund and/or its assistants from the Company in
connection with the Study (hereinafter: "The Confidential
Information") shall be treated as confidential both during the
Study and for a period of three (3) years following its
termination. The Confidential Information shall not be
disclosed to any third party without prior written approval
from the Company, except f requested by law and/or court order
and/or the FDA or any national regulatory health authority.
This restriction shall not apply to Confidential Information
which is, or becomes, public domain through no fault of the
Fund, the Hospital or the Investigator and/or was obtained by
the Fund and/or by the Investigator from another source as
proved by documentary evidence.
4.2. The parties undertake to maintain the confidentiality of all
details relating to the patients participating in the Study.
It is hereby agreed that the Fund shall not release any
details of the identity of the patients and the Company
undertakes that if for any reason whatsoever, it should become
privy to such details, it shall maintain them in strict
confidentiality.
4.3. With the exception of personal and confidential medical
records, all data generated during the course of the Study
will become the property of the Company and shall not be
disclosed to any third party without the prior written
approval of the Company.
4.4. Any inventions or discoveries made by the Fund during the
course of the Study relating to use of the drug under study
shall be disclosed to the Company and shall become its
property. All other inventions developed by the Fund and/or
the Hospital under this study shall remain and/or become the
property of the Hospital. The Fund, the Hospital and the
Investigator will cooperate fully with the Company in any and
all of its efforts to obtain patents and to enforce said
patents throughout the world, without payment to the Fund, the
Hospital or the Investigator but entirely at the expense of
the Company.
5. TERM AND TERMINATION
5.1. The term of this Agreement shall be from the date of its
execution by the last party (subject to approval as
conditioned in clause 1.2 above, whichever is later) until the
Study is either completed according to the Study Protocol or
terminated. It is anticipated that this study should be
completed by June 1, 2003.
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5.2. The Company retains the right to terminate this study for good
and sufficient reasons at any time subject to thirty (30) days
prior written notice. In the event early termination occurs,
the costs of non-cancelable items shall be paid by the Company
and payment of the agreed Remuneration shall be prorated
according to Article 6.
6. REMUNERATION
6.1. In return for the Fund's performance of the Study, the Company
undertakes to pay the Fund U.S. Dollars minimum of $105,000 up
to a maximum of $210,000 (hereinafter: "The Remuneration")
according to the payment schedule listed in Schedule C
attached o this Agreement and constituting an integral part
thereof.
6.2. The Fund shall provide the Company with a receipt for each
installment paid.
7. CLAIMS, LIABILITY AND INSURANCE
Subject to the fulfillment of the Fund's undertakings stated in paragraph 2
supra:
7.1. The Company shall bear sole responsibility and bear any
payment and/or compensation and/or liability for any damage
whatsoever caused to any person, directly or indirectly, as a
result of the performance of the Study, but only up to the
limits of insurance coverage obtained by the Company for this
purpose, as set forth in Schedule 0 annexed hereto.
7.2. The Company shall pay all expenses associated with any
proceedings taking place as a result of a complaint and/or
legal claim submitted by any person in respect of damages
claimed to have been caused as a result of the performance of
the Study. Whenever applicable, the Company shall immediately
indemnify the Fund and/or the Hospital and/or the State of
Israel and/or any of their employees and/or their agents
and/or their representatives and/or the Investigator for any
such expenses paid, together with attachment differences, but
only up to the limits of insurance coverage obtained by the
Company for this purpose, as set forth in Schedule I annexed
hereto.
7.3. The Fund will notify the Company, within 20 working days from
the day the Fund acquired such knowledge, of any complaint,
claim, or injury relating to the Study.
7.4. Without derogating from its above liabilities, the Company
shall cover the medical personnel conducting the Study, the
Fund and the Hospital (hereinafter: "The Beneficiaries") with
an insurance policy, for an amount similar to the amount with
which the State of Israel insures its physicians,
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against third party's claims and/or demands associated with
the performance of the Study.
8. ADVERSE EFFECTS
8.1. In the event one or more of the participating patients sustain
any adverse effects related to the Study, the Investigator
shall inform the Company and/or the Hospital's Helsinki
Committee and/or the Hospital management and/or the authorized
national health authorities. The Investigator and the Fund are
also entitled to immediately cease the performance of the
Study and report their decision to the Company.
8.2. In the aforementioned event, the Company undertakes to break
the study medications code and immediately inform the
Investigator and/or the Fund the content of the medication
received by each participating patient. The Company will also
immediately take all measures at its disposal, to evaluate the
risk to the other patients and will instruct the Investigator
which measures to take in regard to that risk.
9. LAW AND VENUE
Any dispute between the parties to this Agreement, including its breach
and/or its implementation and/or its termination, shall be decided
exclusively by the competent court of law in Tel-Aviv, Israel which
shall have exclusive jurisdiction and the law that shall apply in such
case shall be the statutes and laws of the State of Israel.
10. MISCELLANEOUS
10.1. NON EMPLOYMENT. For the purpose of this Agreement, the Fund
and/or its servants and/or investigators will be deemed an
independent contractor and not an employee of the Company.
10.2. GOOD FAITH. Both parties shall be under a duty to act in good
faith in the performance and enforcement of this Agreement.
10.3. NOTICES. Except as otherwise provided in this Agreement, all
notices permitted or required by this Agreement shall be in
writing and shall be deemed to have been duly served (I) upon
personal delivery (ii) upon facsimile transmission (receipt of
which has been orally confirmed by the recipient) or (iii)
Seven (7) business days after deposit, postage prepaid, return
receipt requested, if eth by Registered Mail and addressed to
the address of the parties first above stated or in accordance
with such other address information as the party to receive
notice may provide in writing to the other party in accordance
with the above notice provisions. Any
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notice given by any other method will be deemed to have been
duly served upon receipt thereof.
10.4. ASSIGNMENT. This Agreement is personal to the parties and may
not be assigned without the prior written consent of the other
party.
10.5. CAPTIONS. Any paragraph or other captions are inserted for
convenience only and shall not be considered a part of or
affect the interpretation or construction of any of the
provisions of this Agreement.
10.6. WAIVERS. No course of dealing in respect of, nor any omission
or delay in the exercise of, any right, power, or privilege by
either party shall operate as a waiver thereof, nor shall any
single or partial exercise thereof preclude any further or
other exercise thereof or of any other, as each such right,
power, or privilege may be exercised either independently or
concurrently with others and as often and in such order as
each party may deem expedient.
10.7. SURVIVAL OF PROVISIONS. Notwithstanding termination of this
Agreement for any reason, this Agreement shall remain in full
force and effect with respect to the parties undertakings
related to the Study and to the provisions of Article 4 which
shall survive any such termination.
10.8. ENTIRE AGREEMENT; AMENDMENTS. This Agreement, including,
without limitation, its schedules, contains the entire
agreement of the parties with respect to its subject matter.
No oral or prior written statements or representations not
incorporated herein shall have any force or effect, nor shall
any part of this Agreement be amended, supplemented, waived or
otherwise modified except in a writing signed by both parties.
10.9. 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.
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.
/s/ Kaplan Medical Center
Affiliated to the Hebrew University
/s/ SHALOM Z. HIRSCHMAN, MD MEDICAL SCHOOL AND HADASSAH
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The Company The Fund
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I the undersigned Zev M Shtoeger hereby declare and confirm that I read and
understood the Agreement, I agree to be appointed as the Investigator of the
Study on behalf of the Fund, and I undertake to comply with all the conditions,
provisions, instructions and stipulations of the Agreement.
/s/ ZEV M. SHTOEGER
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The Investigator
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