EXHIBIT 10.33
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH REGARD TO PORTIONS OF THIS EXHIBIT
AMENDMENT TO CLINICAL DEVELOPMENT AGREEMENT
This Amendment is entered into this 27th day of October, 1999 by and
between Vion Pharmaceuticals, Inc., Four Science Park, New Haven, Connecticut
("Vion"), Covance Clinical Research Unit Ltd., Hyde Street, Leeds, United
Kingdom ("Covance"), and Covance Inc., 000 Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxx
Xxxxxx ("Covance"), and amends the Clinical Development Agreement between Vion
and Covance dated June 6, 1997 ("Original Agreement").
WHEREAS, the parties to the Original Agreement desire to effect an
amicable and efficient transfer of Covance's responsibilities (except as
provided hereinafter in Section 2(b)) and terminate the Original Agreement.
NOW THEREFORE, in consideration of the premises and the undertakings of
the parties hereinafter set forth, the parties agree as follows:
1. DEFINITIONS
a. "Affiliate" means an individual, trust, business trust, joint
venture, partnership, corporation, limited liability company,
association or any other entity which owns, is owned by or is under
common ownership with a party. For the purposes of this definition,
the term "owns" (including, with correlative meanings, the terms
"owned by" and "under common ownership with") as used with respect
to any party, shall mean the possession (directly or indirectly) of
more than fifty percent (50%) of the outstanding voting securities
of a corporation or comparable equity interest in any other type of
entity.
b. "FDA" means the United States Food and Drug Administration (or its
substantial equivalent in any foreign country).
c. "IND" means Investigational New Drug Application No. 52,804 filed
for the Drug with the FDA or its substantial equivalent in any
foreign country.
d. All capitalized terms used herein and not otherwise defined, shall
have the meaning ascribed thereto under the Original Agreement.
e. "BIPI" means Boehringer Ingelheim Pharmaceuticals, Inc.
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2. OBLIGATIONS OF COVANCE
a. Covance shall use its best efforts to cooperate with Vion and BIPI
to transition its responsibilities under the Original Agreement
according to the Transition Plan, which is attached as Appendix 1
to this Amendment (and which may be amended from time to time
during the transition period). For the purposes of this amendment,
"best efforts" shall be those efforts Covance would apply to a
similar project for its most important clients in good standing.
BIPI and Vion agree that they shall accept such responsibilities in
accordance with the Transition Plan no later than November 30,
1999.
b. Covance shall continue to perform IVRS patient randomization and
assignment and clinical trial supply management according to the
methodology and fee structure as under the Original Agreement and
in accordance with the Roles and Responsibilities for Protocol No.
PORF-96-001 dated January 15, 1999 and approved January 18, 1999.
The fee to Covance for IVRS patient randomization and assignment
and clinical trial supply management shall be []. The parties agree
that fees described in this Section 2(b) apply to the first []
patients randomized and assigned. Covance agrees to perform further
IVRS randomization and assignment and clinical trial supply
management at BIPI's request on a PRO RATA cost basis.
c. Covance will continue to be responsible for site management of each
individual research site in accordance with the methodology
described in the Original Agreement and Transition Plan until BIPI
(or a BIPI Affiliate) is prepared to take over responsibility for
such tasks but in no event later than November 30, 1999. It is
understood and agreed that during the transition herein described,
these tasks may be performed jointly by Covance and BIPI (or a BIPI
Affiliate). All agreements with Investigators shall be assigned by
Covance and accepted by BIPI (or a BIPI Affiliate) no later than
such date pursuant to a written acknowledgment of such assignment
and acceptance from each individual research site at which point
Covance's responsibility for such tasks shall cease. After BIPI (or
a BIPI Affiliate) has executed a contract with an individual
research site, Covance shall continue to be responsible for
reporting all (including Pharm-Olam generated) expeditable and/or
severe adverse events to the FDA (or other relevant agencies) until
the date upon which BIPI provides written notice to Covance that
acceptable data bases have been established at BIPI and all
relevant BIPI Affiliates, but in no event shall Covance be so
responsible beyond November 30, 1999.
d. BIPI and Covance shall enter a contract for performance of the
activities described in Section 2(b).
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3. OBLIGATIONS OF VION
a. For all activities performed by Covance and not yet paid by Vion
through September 27, 1999, Vion shall pay Covance a total of [].
This payment shall be in full settlement of all amounts owed to
Covance by Vion for Covance activities under the Original Agreement
through September 27, 1999 and shall be paid to Covance no later
than November 30, 1999.
x. Xxxx shall reimburse Covance for pass-through Investigator fees
that have been incurred by Covance through September 27, 1999 but
not yet reimbursed by Vion. The amount of the pass-through
Investigator fees incurred through September 27, 1999 is
approximately []. For all other outstanding pass-through fees
incurred by Covance through September 27, 1999, Vion shall
reimburse Covance a total of []. The sums described herein shall be
paid no later than November 30, 1999.
c. For all fees and pass-through costs other than Investigator fees
after September 27, 1999, including the transition activities
described in Section 2(a) above and the Transition Plan, Vion shall
pay Covance a fee of [], such fee payable within fifteen (15) days
of the date upon which BIPI provides written notice to Covance that
acceptable data bases have been established at BIPI and all
relevant BIPI Affiliates, but in no event later than December 15,
1999. Vion shall continue to reimburse Covance for pass-through
Investigator fees incurred by Covance within thirty (30) days of
invoice.
4. ORIGINAL AGREEMENT
a. Upon the date of formal transfer of responsibility for all INDs
from Vion to BIPI as defined in Section 5 below, the Original
Agreement will terminate.
b. The confidentiality obligations contained in Section 5, the
indemnification provisions of Sections 2(l) and 3(h) of the
Original Agreement shall survive termination of the Original
Agreement. In addition, the parties agree that the obligation to
comply with all applicable regulations shall also survive
termination of the Original Agreement.
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5. RELEASE FROM LIABILITY
a. Upon full review of all the data and information relating to
Covance's work under the Original Agreement and formal transfer of
responsibility for all INDs from Vion to BIPI, Vion and Covance
shall execute a mutual release, from further responsibility or
liability under the Original Agreement (including a waiver of any
early termination penalties described in Section 8 of the Original
Agreement). Such release shall not release Vion or Covance from the
claims of third parties pursuant to Sections 2(l) and 3(h) of the
Original Agreement. For the purposes of this Amendment, "formal
transfer of responsibility" is defined, on a country-by-country
basis, as notification from BIPI (or a BIPI Affiliate) to the FDA
of the transfer of sponsor responsibility for the IND from Vion to
BIPI (or a BIPI Affiliate). The review described herein shall be
completed by BIPI and Vion no later than March 31, 2000. In the
event of any complaints with respect to the data and information so
reviewed, BIPI and Vion shall provide Covance with prompt written
notice of the same and Covance shall be given an opportunity, if
practicable, to cure any identified deficiency. In the event of a
dispute among the parties with respect to this review, the parties
agree to submit the dispute to non-binding mediation in the event
that executive discussion cannot resolve the issue to everyone's
satisfaction.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the date and year first
written above.
VION PHARMACEUTICALS, INC. COVANCE CLINICAL
RESEARCH UNIT LTD.
By: /s/ Xxxxxx Xxxxxxx By: /s/ Xxxxxxx X. Xxxxxxx, Xx.
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Its: VP Operations Its: Director
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Date: October 27, 1999 Date: October 28, 1999
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COVANCE INC.
By: /s/ Xxxxxxx X. Xxxxxxx, Xx.
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Its: Senior Vice President and Chief Financial Officer
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Date: October 28, 1999
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The undersigned hereby agrees to be bound by the applicable provisions of
Sections 2(a), (c), (d) and 5 hereof.
BOEHRINGER INGELHEIM
PHARMACEUTICALS, INC.
By: /s/ X. Xxxxx
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Its: Sr. VP Medical/DRA
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Date: October 27, 1999
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