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EXHIBIT 10.16
[Confidential treatment has been requested for portions of this exhibit. The
confidential portions have been redacted and are denoted by [**]. The
confidential portions have been separately filed with the commission.]
AMENDMENT AND AGREEMENT
WITH RESPECT TO
LICENSE AGREEMENT
THIS AMENDMENT AND AGREEMENT effective as of October 5, 1996,
(hereinafter, the "Amendment") amends the License Agreement effective as of
November 1, 1993, by and among Xxxxxxxxx Wellcome Co. ("B.W. Co."), The
Wellcome Foundation Limited ("WFL"), and CTRC Research Foundation ("CTRC")
(hereinafter, the "Original Agreement") and sets forth certain other
acknowledgements, consents and other agreements with respect to the Original
Agreement.
W I T N E S S E T H:
WHEREAS, pursuant to the Original Agreement, CTRC obtained from B.W.
Co. and WFL, an exclusive worldwide license to certain patent rights, know-how
and other rights related to the chemical compound known as crisnatol mesylate;
WHEREAS, pursuant to an Assignment of Rights and Assets, effective as
of November 18, 1994, CTRC assigned and transferred to its wholly-owned
subsidiary Biovensa, Inc., ("Biovensa"), all of the rights and obligations of
CTRC contained in or arising out of, the Original Agreement;
WHEREAS, by virtue of an Amended Certificate of Authority of Biovensa,
filed with the Secretary of State of the State of Texas on January 18, 0000,
Xxxxxxxx formally changed its name to ILEX Oncology, Inc. ("Ilex"), and as such
Ilex is the legal successor-in-interest to all the rights and obligations of
CTRC contained in, or arising out of, the Original Agreement;
WHEREAS, by virtue of Articles of Amendment to the Articles of
Incorporation of B.W. Co., filed with the Secretary of State of the State of
North Carolina on October 31, 1995, B.W. Co. formally changed its name to Glaxo
Wellcome, Inc. ("GW"), and as such GW is the legal successor-in-interest to all
the rights and obligations of B.W. Co. contained in, or arising out of, the
Original Agreement;
WHEREAS, Ilex now desires to sublease certain of its rights and
obligations contained in the Original Agreement to Xxxxxxx Pharmaceutica, N.V.,
a Belgium corporation ("Xxxxxxx"), pursuant to a Development and License
Agreement (hereinafter, the "Xxxxxxx Sublicense");
WHEREAS, Article 24 of the Original Agreement provides that the
parties may alter the provisions of the Original Agreement by a written
instrument duly executed by each of the parties thereto, and
WHEREAS, each of Ilex, GW and WFL desire to amend the Original
Agreement, as more particularly set forth herein, and each of Ilex, GW and WFL
desire to provide
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for certain other agreements with respect to the Original Agreement and the
Xxxxxxx Sublicense.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual promises and covenants set forth herein, Ilex, GW, WFL and Xxxxxxx
hereby agree as follows:
SECTION 1 - DEFINITIONS, ACKNOWLEDGEMENTS & CONSENT
1.1 Unless otherwise specifically defined herein, each term used
herein which is defined in the Original Agreement shall have the meaning
assigned to such term in the Original Agreement.
1.2 Each of Ilex, GW, WFL and Xxxxxxx acknowledge and agree that
GW is the legal successor-in-interest to all the rights and obligations of B.W.
Co. contained in, or arising out of, the Original Agreement, and that therefore
each and every reference to B.W. Co. in the Original Agreement shall instead be
deemed to be to GW.
1.3 Each of Ilex, GW, WFL and Xxxxxxx acknowledge and agree that
Ilex is the legal successor-in-interest to all the rights and obligations of
CTRC contained in, or arising out of, the Original Agreement, and that
therefore each and every reference to CTRC in the Original Agreement shall
instead be deemed to be to Ilex.
1.4 Ilex hereby represents and warrants to GW and WFL that on
November 18, 1994, CTRC assigned and transferred to Biovensa, and Biovensa
accepted and assumed from CTRC, all the rights and obligations of CTRC
contained in, or arising out of, the Original Agreement. In reliance upon the
representation and warranty made in the preceding sentence, each of GW and WFL
hereby consent to the assignment by CTRC to Biovensa, and the corresponding
acceptance and assumption by Biovensa, of all of CTRC's rights and obligations
contained in, or arising of, the Original Agreement.
SECTION 2 - ADDITIONAL USES
Ilex, GW and WFL agree that Article 3 of the Original Agreement is
hereby amended by adding the following provisions as new Article 3.4:
"3.4 Additional Uses Outside the Field. If Ilex or its
Affiliates, sublicensees or assignees discover a use, indication or
potential use or indication of the Product which is outside the scope
of the Field (such use, indication or potential use or indication
being hereinafter referred to as an "Additional Use"), Ilex and its
Affiliates, sublicensees or assignees (as applicable) shall promptly
notify GW in writing of such Additional Use of the Product. for a
period of forty-five (45) days from the date of the written notice of
Additional Use (the "Exercise Period"), Ilex may submit a written
proposal to GW with respect to the negotiation of a license by GW to
Ilex of the rights related to such Additional
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Use (such written proposal to be hereinafter referred to as a
"Proposal of Terms"). The Proposal of Terms shall contain terms and
conditions which are commercially reasonable. If Ilex shall fail to
deliver a Proposal of Terms to GW within the Exercise Period, then in
such event, Ilex shall have no further rights with respect to such
Additional Use. Upon the receipt by GW of a Proposal of Terms from
Ilex within the Exercise Period, GW agrees that for a one hundred and
twenty (120) day period beginning on the date of receipt by GW of such
Proposal of Terms (the "Negotiation Period"), GW shall negotiate in
good faith with Ilex concerning a license to Ilex of the rights
related to the Additional Use which is the subject of such Proposal of
Terms. If the parties are unable to execute an agreement within the
Negotiation Period, then in such event, for a period of one (1) year
following the end of the Negotiation Period, GW shall not offer to
license the rights with respect to such Additional Use to any other
Third Party on terms which are less favorable to GW in material
respects than the terms offered to Ilex during the Negotiation Period.
SECTION 3 - CERTAIN REPRESENTATIONS
Each of GW and WFL hereby represent to Xxxxxxx that, as of the date
hereof, the Original Agreement is in full force and effect. Each of GW and WFL
acknowledge that Ilex has informed GW that Ilex proposes to enter into the
Xxxxxxx Sublicense. Each of GW and WFL represent that, to the best of their
knowledge, as of the date hereof, Ilex is not in material breach of the
Original Agreement.
SECTION 4 - MODIFICATION OF DILIGENCE EXTENSIONS
Ilex, GW and WFL hereby agree that the last sentence in Article 8.2(i)
of the Original Agreement is hereby deleted in its entirety and the following
is hereby substituted in lieu thereof.
"The time periods specified in clauses (a) and (b) above shall each be
subject to three (3) twelve (12) month extensions, at Ilex's election,
by payment to GW of [**] ($ [**] ) for the first such
twelve (12) month extension, and by payment to GW of [**]
($ [**] ) for the second such twelve (12) month extension, and by
payment to GW of [**] Dollars ($ [**] ) for the third
such twelve (12) month extension, such payments to be made within the
first thirty (30) days of each extension."
SECTION 5 - RIGHTS UPON TERMINATION
Each of Ilex, GW WFL and Xxxxxxx agree that in the event that Ilex
breaches any of the provisions in the Original Agreement and fails to cure such
breach within the period of time allotted in the Original Agreement, and GW and
WFL, as a result thereof, terminate the Original Agreement, and Xxxxxxx is not
in default of any of its obligations contained in the Xxxxxxx Sublicense, then
in such case Xxxxxxx shall
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have a period of thirty (30) days after such termination to fully cure such
breach of the Original Agreement. In the event that Xxxxxxx fully cures such
breach within such thirty (30) day period, Xxxxxxx shall have the right to
assume that Original Agreement and Xxxxxxx'x name shall be substituted for Ilex
in the Original Agreement, provided, however, that if Xxxxxxx shall exercise
its right to assume the Original Agreement pursuant to this provision, Xxxxxxx
shall by virtue of such exercise, and without further action, accept and assume
all of Ilex's responsibilities, liabilities and obligations that are stated in,
arise out of, or are associated with, the Original Agreement, including without
limitation, the responsibilities, liabilities and obligations set out in
Article 11 of the Original Agreement.
SECTION 6 - MODIFICATION OF NON-U.S. DEVELOPMENT OBLIGATIONS
Ilex, GW and WFL hereby agree that Article 8.3 of the Original
Agreement is hereby deleted in its entirety and the following provision
inserted in lieu thereof.
"8.3 Non-U.S. Development. No later than the filing by
Ilex of an NDA for a Product in the U.S., Ilex shall use reasonable
efforts to enter into a sublicense agreement with one or more Third
Parties for development and marketing outside the U.S. Such
sublicense agreement shall require such Third Party or Third Parties
to use reasonable efforts, commensurate with the efforts it would
normally exercise for products of similar potential sales volume and
consistent with its overall business strategy."
SECTION 7 - NOTICES
Ilex, GW and WFL hereby agree that the address for CTRC which appears
in Article 21 of the Original Agreement is hereby deleted in its entirety and
the following is hereby substituted in lieu thereof.
"ILEX Oncology, Inc.
00000 Xxxxxxx Xxxxx, Xxx. 000
Xxx Xxxxxxx, Xxxxx 00000-0000
Attn: President
Fax: (000) 000-0000"
Ilex, GW and WFL hereby agree that the address for B. W. Co. which
appears in Article 21 of the Original Agreement is hereby deleted in its
entirety and the following is hereby substituted in lieu thereof:
"Glaxo Wellcome Inc.
Five Xxxxx Xxxxx
Xxxxxxxx Xxxxxxx Xxxx
Xxxxx Xxxxxxxx 00000
Attn: General Counsel
Fax: (000) 000-0000"
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SECTION 8 - EFFECT OF AMENDMENT
Unless specifically amended or modified by this Amendment, the terms
of the Original Agreement shall remain in full force and effect.
SECTION 9 - ENTIRE AGREEMENT; COUNTERPARTS
This Amendment and the Original Agreement, as modified by this
Amendment, contain the entire understanding of the parties hereto and represent
a complete and exclusive statement of agreement with respect to the subject
matter contained herein. This Amendment may be executed in any number of
counterparts.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date indicated above.
ILEX ONCOLOGY INC.
By:
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Name:
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Title:
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GLAXO WELLCOME INC.
By:
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Name: Xxxx X. Xxxxxxxx
Title: Vice President -
Business Development and Planning
General Manager -
Specialty Divisions
THE WELLCOME FOUNDATION LTD.
By:
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Name:
-----------------------------------------
Title:
----------------------------------------
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XXXXXXX PHARMACEUTICA, N.V.
By:
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Name:
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Title:
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