Exhibit 10.14
CLINICAL TRIAL AGREEMENT
THIS AGREEMENT is made and entered into as of the 12th day of December,
1994 (hereinafter "Effective Date") by and between
XXXXX-XXXXXXXXX INSTITUTE FOR CANCER RESEARCH and its affiliate,
MEMORIAL HOSPITAL FOR CANCER AND ALLIED DISEASES, both having a principal
place of business at 0000 Xxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000, membership
corporations of the State of New York (hereinafter "SKI/MEMORIAL") and
ACTIVE BIOTHERAPIES, INC., a corporation of the State of Delaware
having its principal place of business at 000 Xxx Xxx Xxxx Xxxxx Xxxx,
Xxxxxxxxx, Xxx Xxxx 00000, (hereinafter "ABI").
WITNESSETH
WHEREAS, SKI/MEMORIAL has established and maintains a Clinical
Immunology Service, a Division of Hematologic Oncology, in the Department of
Medicine and has acquired expertise in conducting research investigations,
clinical trials and laboratory test evaluations; and
WHEREAS, ABI conducts business in the development, manufacture and sale
of therapeutic products; and
WHEREAS, ABI desires SKI/MEMORIAL to conduct a clinical trial to
determine the safety and efficacy of GM2 covalently attached to KLH plus the
immunological adjuvant QS-21 in patients with melanoma (hereinafter "GM2-KLH
conjugate"), said trial entitled
VACCINATION OF MELANOMA PATIENTS WITH GM2 COVALENTLY ATTACHED TO KLH
(GM2-KLH) PLUS THE IMMUNOLOGICAL ADJUVANT QS-21: TRIAL COMPARING DOSES OF
GM2-KLH
(hereinafter the "Study").
NOW, THEREFORE intending to be legally bound and upon the terms,
conditions and covenants hereinafter set forth, SKI/MEMORIAL and ABI agree as
follows:
ARTICLE I - THE STUDY
1.1 The Study under this Agreement will be conducted under the protocol
approved by SKI/MEMORIAL's Human Subject Institutional Review Board
(hereinafter "IRB"), based on the protocol annexed hereto as Exhibit A
(hereinafter "Protocol"). SKI/MEMORIAL shall submit the Protocol for approval
to the IRB. ABI shall supply Study drug after ABI has:
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a. received a mutually executed copy of this Agreement;
b. received documentation from the Office of Industrial Affairs that
SKI/MEMORIAL's IRB has approved the Protocol;
Promptly after SKI/MEMORIAL's IRB has approved the final Protocol, the
Principal Investigator shall forward a copy to the Office of Industrial
Affairs, and the Office of Industrial Affairs shall forward a copy to ABI.
The Principal Investigator shall also forward to the Office of Industrial
Affairs any subsequent change to the Protocol, and the Office of Industrial
Affairs shall forward the change to ABI.
1.2 As part of this Agreement, SKI/MEMORIAL shall appoint Xx. Xxxx X.
Xxxxxxx and/or such other physicians as it may deem appropriate as
investigators (hereinafter "Investigators") to oversee the Study. If Xx.
Xxxxxxx should become unable to complete the Study, SKI/MEMORIAL shall
consult with ABI regarding the appointment of a new principal investigator.
SKI/MEMORIAL will negotiate in good faith to select a new principal
investigator so that the Study can continue.
1.3 The Investigators on behalf of SKI/MEMORIAL shall prepare and
maintain records and case histories with all pertinent data documented as
required by the Protocol on case report forms supplied by ABI. All patient
data shall be kept confidential. Information provided to ABI shall not
disclose patient names, except to the extent that the patient consent form
permits.
1.4 The Investigators shall also immediately notify ABI of any adverse
reaction in the course of the Study of which they become aware.
1.5 All applicable government laws, rules, regulations and guidelines,
including those of the United States Food and Drug Administration
(hereinafter the "FDA"), shall be adhered to by SKI/MEMORIAL and ABI in the
performance and documentation of the Study.
1.6 ABI shall provide SKI/MEMORIAL with any investigational protocols,
pre-clinical or background information which are germane to the Study.
1.7 ABI shall provide, without cost to SKI/MEMORIAL, sufficient
amounts of its GM2-KLH conjugate to SKI/MEMORIAL to conduct the Study.
SKI/MEMORIAL may not use this GM2-KLH conjugate in any way other than as
specified in the Protocol.
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1.8 SKI/MEMORIAL shall use reasonable efforts to obtain an
institutional IND for purposes of conducting the Study. At ABI's request any
time in the three years after the Effective Date, SKI/MEMORIAL will assign
the IND to ABI at no additional charge and write a letter to the FDA to
inform them of the assignment of the IND to ABI. ABI shall indemnify
SKI/MEMORIAL for any use ABI makes of the IND after SKI/MEMORIAL has assigned
it to ABI, including attorney fees.
ARTICLE II - SKI/MEMORIAL STAFF AND FACILITIES
2.1 The Study shall be carried out at SKI/MEMORIAL under the
supervision of SKI/MEMORIAL's IRB and the Investigators indicated above.
2.2 SKI/MEMORIAL shall provide the physician, laboratory, statistical,
and clinical support staff levels of effort required to complete the Study.
ARTICLE III- REPORTS
3.1 SKI/MEMORIAL shall keep ABI advised of the status of the Study via
periodic reports. The frequency of such reports shall be mutually agreed to
by both parties. There shall also be a final report of the Study presented to
ABI.
3.2 All reports submitted to ABI shall become the property of ABI and
may be used by ABI without, however, making any reference to Memorial
Xxxxx-Xxxxxxxxx Cancer Center, Memorial Hospital for Cancer and Allied
Diseases or Xxxxx-Xxxxxxxxx Institute for Cancer Research, unless such
reference appears in a communication with the FDA or as otherwise required by
law. If ABI desires to make reference to any of the foregoing in utilizing
the results of the Study, ABI must first obtain written consent from
SKI/MEMORIAL. SKI/MEMORIAL shall respond to any such ABI's request for
release of information within thirty (30) days after receiving ABI's request.
ARTICLE IV - PUBLICATION
4.1 Notwithstanding anything contained herein to the contrary including
without limitation Articles 5.1 and 9.6, SKI/MEMORIAL may freely publish the
results of its investigative findings hereunder. The authorship and contents
(including scientific conclusions and professional judgments) of any paper
submitted shall be determined by SKI/MEMORIAL. SKI/MEMORIAL shall provide ABI
with a copy of the papers prepared for publication prior to their submission
to a scientific journal or presentation at scientific meetings. ABI shall
have thirty (30) days to review the papers. ABI shall not make any editorial
changes in the papers, but may delete any of its Confidential Information (as
defined below) contained therein. ABI personnel shall be acknowledged with
customary scientific practice.
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ARTICLE V - CONFIDENTIAL INFORMATION
5.1 In order to effectively complete the Study, it may be necessary or
desirable for the parties to disclose proprietary, trade secret and/or other
confidential information (herein "Confidential Information") to one another.
Each party agrees that any such Confidential Information disclosed to it or
to its employees shall be used only in connection with the legitimate
purposes of this Agreement; shall be disclosed only to those who have a need
to know it, and shall be safeguarded with the same care normally afforded
such Confidential Information in the possession, custody or control of the
party receiving the Confidential Information provided, however, that the
disclosing party specifies in writing the nature and identity of the
Confidential Information and the manner and time of disclosure. The foregoing
shall not apply when, after and to the extent the Confidential Information
disclosed becomes generally available to the public through no fault of the
receiving party, was already known to the receiving party at the time of
disclosure as evidenced by written records in the possession of the receiving
party prior to such time, or is subsequently received by the receiving party
in good faith from a third party without breaching any confidential
obligation between the third party and the disclosing party.
ARTICLE VI - COMPENSATION
6.1 In consideration for SKI/MEMORIAL's participation and to cover the
costs associated with the Study, ABI shall pay SKI/MEMORIAL a total of
[***]
6.2 SKI/MEMORIAL shall discuss, if ABI so requests, budgetary matters
with ABI, but reserves the right to be the final control on budgetary
categories and expenditures. SKI/MEMORIAL shall not be obligated to provide
expenditure reports, or to submit to audits by ABI.
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[***] Confidential Treatment Requested
6.3 The checks shall be made payable to XXXXX-XXXXXXXXX INSTITUTE FOR
CANCER RESEARCH (Xxxxx-Xxxxxxxxx Institute Tax I.D. No. 00-0000000) and shall
be forwarded to:
Memorial Xxxxx-Xxxxxxxxx Cancer Center
Office of Industrial Affairs
0000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
ABI should note on its check stub or in its transmittal letter that the
payment relates to a Clinical Trial Agreement, SK#1267, under the direction
of Xx. Xxxx X. Xxxxxxx.
ARTICLE VII - INDEPENDENT CONTRACTOR
7.1 Both parties shall, at all times during the performance of this
Agreement, remain as independent contractors and the Agreement shall not make
the parties partners, joint venturers, or agents of one another. No party to
this Agreement shall have the power to bind or obligate the other party.
ARTICLE VIII - TERM AND TERMINATION
8.1 This Agreement shall commence on the Effective Date of this
Agreement and shall continue until completion as provided in the Protocol,
which is estimated at about twelve (12) months from the date hereof.
8.2 This Agreement can be terminated by either SKI/MEMORIAL or ABI
with or without cause upon thirty (30) days prior written notice without
penalty to either party.
8.3 In the event that a.) SKI/MEMORIAL terminates this Agreement prior
to completion of the Study, the amount due to SKI/MEMORIAL from ABI shall be
[***]
any time between the Effective Date and the date of termination of this
Agreement and then completes the Protocol; or b.) ABI terminates this
Agreement then in addition to [***]
8.4 If ABI terminates the Agreement prior to completion of the Study,
ABI shall, if permitted by law and requested by SKI/MEMORIAL, supply
SKI/MEMORIAL, free of charge, with sufficient GM2-KLH conjugate to allow
SKI/MEMORIAL to complete the treatment of those patients participating in the
Study on the date of SKI/MEMORIAL's receipt of ABI's termination notice.
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*** Confidential Treatment Requested
8.5 Sections 3.2, 4.1, 5.1, 8.3, 8.4, 8.5, 9.1, 9.6 and 9.7 shall all
survive the termination of this Agreement.
ARTICLE IX - GENERAL
9.1 ABI shall indemnify, defend and hold SKI/MEMORIAL, and its
affiliate corporation, Memorial Xxxxx-Xxxxxxxxx Cancer Center harmless from
and against all claims, causes of action, suits, damages and costs arising
out of, resulting from, or otherwise in respect of, the manufacture, sale
and/or use of GM2-KLH conjugate except where such claims, causes of action,
suits, damages and costs are the result of negligence on behalf of
SKI/MEMORIAL, its staff or agents. ABI shall have no obligation to indemnify,
defend or hold SKI/MEMORIAL harmless against liability, loss or damage
arising from a failure by SKI/MEMORIAL, its staff or agents to; (i) comply
with any applicable FDA or other governmental requirement or; (ii) adhere to
the terms of the Protocol.
SKI/MEMORIAL shall indemnify, defend and hold ABI harmless from and
against all claims, causes of action, suits, damages and costs arising out
of, resulting from, or otherwise in respect of, the manufacture, sale and/or
use of GM2-KLH conjugate except where such claims, causes of action, suits,
damages and costs are the result of negligence on behalf of ABI, its staff or
agents. SKI/MEMORIAL shall have no obligation to indemnify, defend or hold
ABI harmless against liability, loss or damage arising from a failure by ABI,
its staff or agents to; (i) comply with any applicable FDA or other
governmental requirement or; (ii) adhere to the terms of the Protocol.
9.2 No right or license is granted under this Agreement by either
party to the other either expressly or by implication, except those
specifically set forth herein.
9.3 Nothing contained within this Agreement shall impose an obligation
of exclusivity on one party by the other. Both parties reserve the right to
enter into and participate in other activities (either alone or with a third
party) including, but not limited to, clinical trials and sponsored research
projects.
9.4 All matters affecting the interpretation, validity and performance
of this Agreement shall be governed by the laws of the State of New York
applicable to agreements made and to be performed wholly within the State of
New York. This Agreement, including the Protocol, sets forth the entire
understanding between the parties
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herein, and cannot be changed or amended except by written agreement executed
by the parties. In the event of any inconsistency in this Agreement, the
inconsistency shall be resolved by giving precedence first, to the Articles
of this Agreement, and then, to the Protocol. This Agreement may not be
assigned by either party without the prior written consent of the other party.
9.5 All notices to be given by either party to the other shall be made
in writing by hand delivery or by registered or certified mail, return
receipt requested and addressed to the parties at the following addresses
respectively:
Xxxxx-Xxxxxxxxx Institute for Cancer Research
0000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
(Attention: Director, Office of Industrial Affairs)
(Copy: Xxxxx X. Xxxxx, Senior Vice President)
Active Biotherapies, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxx 00000
(Attention: Xxxx X. Madddon, M.D., Ph.D.
President and CEO)
Any notice shall be effective as of its date of receipt.
9.6 Except as set forth in articles 5.1 and 4.1, as required by law
and/or as may be required in order to maintain a party's status as an exempt
organization under Section 501(c) (3) of the Internal Revenue Code and
regulations thereunder, neither SKI/MEMORIAL nor ABI shall release any
information, publicity, news releases or other public announcement, written
or oral, with regard to the Agreement or any amendment thereto or to
performance hereunder, to newspapers or any other mass communication media
without the prior written approval of the other party. SKI/MEMORIAL shall
respond to any such ABI's request for release of information within thirty
(30) days after receiving ABI's request. ABI shall not use the name of
Memorial Xxxxx-Xxxxxxxxx Cancer Center, Memorial Hospital for Cancer and
Allied Diseases or Xxxxx-Xxxxxxxxx Institute for Cancer Research, or a
variant of any of the foregoing in any advertising, packaging or other
promotional material in connection with the GM2-KLH conjugate except as may
be required by law.
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IN WITNESS THEREOF, SKI/MEMORIAL and ABI have caused this Agreement to
be executed in duplicate by their respective duly authorized officers.
ACTIVE BIOTHERAPIES, INC. XXXXX-XXXXXXXXX INSTITUTE
FOR CANCER RESEARCH, AND
By: /s/ Xxxx X. Xxxxxx MEMORIAL HOSPITAL FOR AND
--------------------------- ALLIED DISEASES
Xxxx X. Xxxxxx, M.D., Ph.D.
President and CEO
Date: Dec. 23, 1994 By: /s/ Xxxxx X. Xxxxx
---------- -------------------------------
Xxxxx X. Xxxxx
Senior Vice President
Research Resources Management
Date: Dec. 12, 1994
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By: /s/ Xxxx X. Xxxxxxx
-------------------------------
Xxxx X. Xxxxxxx, M.D.
Principal Investigator
Date: Dec 4, 1994
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