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EXHIBIT 10.24
CONSENT, ACKNOWLEDGMENT AND
WAIVER AGREEMENT
This CONSENT, ACKNOWLEDGMENT AND WAIVER AGREEMENT (the "Agreement")
dated as of September__, 1994 is entered into by and among CTRC Research
Foundation, a Texas not-for-profit corporation ("CTRC"), Sterling Winthrop
Inc., ("Sterling"), and Biovensa Inc., a Delaware corporation ("Biovensa").
RECITALS
WHEREAS, CTRC's mission includes the discovery, initial development
and testing of therapeutic agents and pharmaceutical products for the treatment
of human cancers;
WHEREAS, Sterling, which is in the process of being acquired by
Sanofi, is involved in the development, manufacture and sale of agents and
pharmaceutical products intended for the treatment of human cancers and is
expected to continue such activities both directly and possibly through its
affiliation with Sanofi after its acquisition by Sanofi;
WHEREAS, Biovensa is a wholly-owned subsidiary of CTRC and was
established to engage in the manufacture and commercial development of
therapeutic agents and pharmaceutical products for the treatment of human
cancers;
WHEREAS, CTRC and Sterling have entered into the Option Agreement,
dated as of October 1, 1992 and amended effective as of April 1, 1994, attached
as Exhibit A hereto (the "Option Agreement"), which Option Agreement provides
Sterling an exclusive option for a designated period to obtain a license to
certain commercial rights of CTRC;
WHEREAS, CTRC and Sterling have entered into the Research
Collaboration Agreement, dated as of October 1, 1992 and amended effective as
of April 1, 1994, attached as Exhibit B hereto (the "Research Collaboration
Agreement"), which Research Collaboration Agreement provides that CTRC and
Sterling shall undertake various cooperative research program activities;
WHEREAS, CTRC and Sterling have entered into that License and
Development Agreement dated as of October 1, 1992 concerning the cancer
compound known as MGBG and attached as Exhibit C hereto (the "MGBG License and
Development Agreement"); and
WHEREAS, in connection with the development of Biovensa's business,
(i) CTRC intends to assign to Biovensa and Biovensa intends to assume various
assets, rights and obligations, including those of CTRC under the MGBG License
and Development Agreement and those of CTRC concerning the anticancer compound
known as Crisnatol Mesylate ("Crisnatol") under the Option Agreement, and
Sterling wishes to consent and
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agree to such assignments; and (ii) CTRC, Sterling and Biovensa wish to
acknowledge their understanding and agree, except with respect to the compound
Crisnatol, that the terms and provisions of the Option Agreement and Research
Collaboration Agreement shall not be applicable to or otherwise binding upon
Biovensa.
NOW THEREFORE, in consideration of the premises contained herein, and
other good and valuable consideration, the receipt and sufficiency of which is
acknowledged, the parties hereby agree as follows:
1. Consent to Assignment and Assumption. Pursuant to Article XV
of the MGBG License and Development Agreement and Article 5.2 of the Option
Agreement, Sterling hereby consents to the assignment by CTRC to Biovensa, and
the corresponding assumption by Biovensa of all of CTRC's rights, obligations
and commitments, including but not limited to all rights of CTRC to receive
compensation and royalties and reimbursement for expenses, arising under the
MGBG License and Development Agreement, and relating to the compound Crisnatol
arising under the Option Agreement. Biovensa agrees that effective as of the
date hereof it will perform all obligations of CTRC under the MGBG License and
Development Agreement and with respect to the compound Crisnatol under the
Option Agreement, and Sterling agrees that effective as of the date hereof it
will make all payments and reimbursements thereunder directly to Biovensa.
2. Acknowledgment and Waiver of Sterling. Sterling acknowledges
that, except for any rights exclusively concerning Crisnatol arising under the
Option Agreement, it does not have and shall not and will not have any rights
or options pursuant to the Option Agreement, the Research Collaboration
Agreement or otherwise with respect to the therapeutic agents, (collectively,
the "Designated Agents, Products and Activities") or with respect to
therapeutic agents, pharmaceutical products and other products and activities
of Biovensa the pursuit or investigation of which is commenced by Biovensa
after the date hereof (collectively, the "Prospective Agents, Products and
Activities"). Effective as of the date hereof, Sterling hereby waives any and
all rights, entitlements and options that might be construed to exist now or in
the future in favor of it under the Option Agreement or Research Collaboration
Agreement relating to the Designated Agents, Products and Activities and any
Prospective Agents, Products and Activities and hereby releases Biovensa from
any and all terms and conditions of such agreements that might be deemed
applicable to it.
3. Acknowledgment of Biovensa. Biovensa acknowledges and agrees
that it shall not acquire or develop any of CTRC's Commercial Rights (as that
term is defined in the Option Agreement) in violation of Sterling's rights
pursuant to the Option Agreement and the Research Collaboration Agreement.
4. Miscellaneous.
4.1 Governing Law. This Agreement shall be governed by and
construed in accordance with the internal laws of the State of New York,
without giving effect to
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any choice or conflict of law provisions or rules (whether of the State of New
York or otherwise) that would cause the application of the laws of any
jurisdiction other than the State of New York.
4.2 Successors and Assigns. This Agreement shall be binding
upon and inure to the benefit of the parties hereto, and their successors and
assigns, however, except as otherwise provided below, no party may assign its
rights, interests or obligations hereunder without the prior written consent of
the other parties. Notwithstanding the foregoing prohibition on assignments,
Sterling shall be permitted to assign its rights, interests or obligations
hereunder to Sanofi or any affiliate thereof without the consent of any other
party hereto.
4.3 Execution in counterparts. This Agreement may be executed
simultaneously in one or more counterparts, each of which shall be deemed an
original agreement, but all of which together shall constitute one and the same
instrument.
4.4 Titles and Headings. The titles and headings to sections
contained herein are for purposes of reference only, and shall not affect the
provision hereof.
4.5 Amendment and Modification. The terms of this Agreement may
be amended, modified, waived or supplemented only by mutual consent set forth
in a writing duly signed by the parties hereto.
4.6 Severability. In case any of the provisions contained in this
Agreement are found to be invalid, illegal or unenforceable in any respect, any
invalidity, illegality or unenforceability shall not affect any other provision
of this Agreement, but this Agreement shall be construed as if such invalid,
illegal or unenforceable provision has been limited or modified (consistent
with its general intent) to the extent necessary so that it shall be valid,
legal and enforceable, or if it shall not be possible to so limit or modify
such invalid or illegal or unenforceable provision or part of a provision, this
Agreement shall be construed as if such invalid or illegal or unenforceable
provision or part of a provision had never been contained herein.
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IN WITNESS HEREOF, CTRC, Sterling and Biovensa have caused this
Agreement to be executed by their duly authorized officers as of the date set
forth above.
CTRC RESEARCH FOUNDATION
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By:
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Title:
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STERLING WINTHROP, INC.
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By:
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Title:
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BIOVENSA INC.
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By:
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Title:
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ANNEX I
DESIGNATED AGENTS, PRODUCTS AND ACTIVITIES
Products to be assigned from CTRC Research Foundation to Biovensa, Inc.:
o Dihydro - 5 - azacytidine
Products identified in the business plan of Biovensa, Inc. that may be acquired
in the future:
o Difluoromethylornithine
o Oxypurinol
o Spirogermanium
o Oral camptothecin
o Piritrexim*
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* An option to license Piritrexim will be granted to Sterling by
Biovensa; the option will be evidenced by an option agreement to be entered
into by Sterling and Biovensa, which agreement will provide, among other
things, that (i) no option fee will be required, (ii) no licensing fee will be
required and (iii) no milestone payment for filing an IND will be required.
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EXHIBIT A
OPTION AGREEMENT
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AMENDMENT I
(to Option Agreement)
THIS AMENDMENT TO THE OPTION AGREEMENT, effective as of the 1st day of April,
1994, is by and between Sterling Winthrop Inc. of 00 Xxxx Xxxxxx, Xxx Xxxx, Xxx
Xxxx 00000 X.X.X. (hereinafter called "Sterling," which expression includes its
subsidiaries, successors and assignees) and the CTRC Research Foundation of
0000 Xxxxxxxxx, Xxxxx 000, Xxx Xxxxxxx, Xxxxx, 00000, U.S.A., a not-for-profit
Texas corporation (hereinafter "CTRC," which expression includes its
subsidiaries, successors and assignees).
WITNESSETH:
WHEREAS, Sterling and CTRC have entered into the Option Agreement (attached
hereto as Exhibit 1) effective as of the 1st day of October, 1992;
WHEREAS, Sterling and CTRC wish to extend the term of the Option Agreement by
one year through December 31, 1996;
WHEREAS, Sterling and CTRC agree to make certain changes to the rights and
obligations of the parties in calendar year 1996;
NOW, THEREFORE, in consideration of the mutual covenants contained herein,
Sterling and CTRC agree to amend the Option Agreement as follows:
ARTICLE I - DEFINITIONS
Replace paragraph d) with the following:
d) "COMMERCIAL RIGHTS" shall mean CTRC's legal right by patent,
contract, agreement, copyright, trademark, or other means to
make, have made, sell or have sold in any country any
compound, material, technology or know-how within the Field of
Use for commercial purposes, including Inventions, Know-How or
Products. Effective January 1, 1996, Commercial Rights shall
be limited to Commercial Rights arising from the Research
Program.
Replace paragraph e) with the following:
e) "CTRC AFFILIATE" shall mean any present or future firm,
company, joint venture or other entity which directly or
indirectly is controlled by or is under the common control of
CTRC. "Control" shall mean the legal power to direct or cause
the direction of the general management and policies of such
entity whether through ownership of at least fifty-one (51%)
percent of voting securities, by contract or otherwise.
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Replace paragraph j) with the following:
j) "INVENTION" shall mean any invention or discovery (whether or
not patented or patentable) in the Filed of Use which is
originated or conceived or first reduced to practice.
Effective january 1, 1996, Inventions shall be limited to
inventions or discoveries (whether or not patented or
patentable) arising from the Research Program.
Delete paragraph u) and reletter paragraphs v) through dd) sequentially.
ARTICLE II - GRANT OF OPTION
Replace Article 2.1 with the following:
2.1 Upon execution of this Agreement and payment of the option fee
according to Article 4.1, CTRC hereby grants to Sterling an exclusive
option (hereinafter the Option) for a period of fifty-one (51) months
from the Effective Date (October 1, 1993) to evaluate CTRC Information
and obtain a license to any Commercial Rights.
ARTICLE IV - FEES, MILESTONE PAYMENTS AND ROYALTIES
Replace Article 4.1 with the following:
4.1 OPTION FEE: Upon execution of this Agreement and payment of
the first of four annual option payments of five hundred thousand
($500,000) dollars, CTRC shall grant to Sterling the exclusive option
set forth in Article 2.1 for the period beginning with the Effective
Date and ending fifty-one (51) months therefrom. The total Option Fee
for this fifty-one (51) month term is two million ($2,000,000)
dollars. During the term of this Agreement, Sterling's exclusive
Option will remain in effect so long as Sterling pays the annual
option fee which shall be due no later than the annual Anniversary
Date of this Agreement.
ARTICLE V - ASSIGNMENT
Replace Article 5.2 with the following:
5.2 CTRC shall be entitled, with the consent of Sterling which
shall not be unreasonably withheld, to assign, transfer, or in any
manner provide, in whole or part, the benefit and/or burden of this
Agreement to a subsidiary or CTRC Affiliate or the University of Texas
Health Science Center at San Antonio; provided that such CTRC
Affiliate, subsidiary, or UTHSCSA undertakes and agrees in writing to
assume, observe and perform the rights and powers and/or duties and
obligations of CTRC under the provisions of this Agreement, being
assigned, transferred or otherwise provided.
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EFFECT OF AGREEMENT
The parties agree that nothing herein is intended to supersede or
modify any of the rights and obligations of the Parties in effect or which have
accrued during the initial term of the Option Agreement except for CTRC's
assignment rights as described in Article 5.2.
IN WITNESS WHEREOF, the parties hereto have executed this Amendment I:
STERLING WINTHROP INC.
By:
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Title:
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Date:
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CTRC RESEARCH FOUNDATION
By:
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Title:
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Date:
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