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[*] INDICATES THAT CONFIDENTIAL MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY IN A REQUEST FOR CONFIDENTIAL TREATMENT WITH THE SECURITIES
AND EXCHANGE COMMISSION
Exhibit 10.54
AMENDMENT No. 1
TO LICENSE AND DEVELOPMENT AGREEMENT
BETWEEN CELTRIX PHARMACEUTICALS, INC.
AND GENZYME CORPORATION
As of June 24, 1994, Celtrix Pharmaceuticals, Inc.
(hereinafter "Celtrix") and Genzyme Corporation (hereinafter "Genzyme") entered
into a License and Development Agreement (hereinafter "the Agreement"). Subject
to the modifications contained in this Amendment No. 1, the Agreement shall
continue in full force and effect.
In order to resolve any issues outstanding between Celtrix and
Genzyme with respect to the Agreement and its subject matter, with the exception
of transfer of any rights in Licensed Technology as defined in the Agreement,
and in accordance with Section 12.6, Celtrix and Genzyme now wish to amend the
Agreement as follows. The effective date of this amendment shall be the latest
date of execution hereof by the parties, with all other terms of the Agreement
continuing in full force and effect.
I. Revision of Article 1, Section 1.26.
Section 1.26 shall be deleted and replaced with the following:
1.26. "Territory" means worldwide including Japan, China,
Korea and Taiwan (the "Asian countries").
II. Revision of Article 2, Sections 2.1 and 2.2.
Section 2.1 shall be deleted and replaced with the following:
2.1 Exclusive License. Subject to the terms and conditions of
this Agreement and rights granted to Genentech, Inc., pursuant to the License
Agreement dated April 1, 1993 between Celtrix and Genentech, Inc., Celtrix
hereby grants to Genzyme an exclusive (against Celtrix and all others) right and
license (including the right to grant sublicenses) to Celtrix's rights in the
Territory to make, have made, (including by Celtrix hereunder), use and sell any
Product in the Field (a) the use, manufacture or sale of which is covered by one
or more claims of the Patents or (b)
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Amendment No. 1
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incorporating or manufactured using Licensed Technology. Any Celtrix rights
not specifically licensed hereunder shall continue to be vested exclusively in
Celtrix, and Celtrix shall have the sole authority and discretion to exercise or
refrain from exercising such rights.
Section 2.2 shall be deleted and replaced with the following:
2.2. Acquisition of Third Party Rights. Genzyme shall use all
commercially reasonable efforts to obtain any rights, at its cost, from any
Third Party that are necessary for the manufacture, use or sale of the Product
in accordance with this Agreement. Genzyme shall bear and pay all costs and
royalties due by Celtrix under Sections 3.2, 3.3, 3.4, and 3.5 of the License
Agreement effective as of April 1, 1993 between Celtrix and Genentech, Inc.
("the "Genentech Agreement"), in accordance with the provisions contained in
Section 7.0 of the Genentech Agreement, and Genzyme shall further have the right
to seek and obtain reduction of such royalty provisions, to its sole benefit.
III. Addition to Article 3, Section 3.2.(c)
Section 3.2(c) shall be amended to add the following at the
end of that Section 3.2:
Genzyme hereby waives and releases Celtrix from any obligation
to provide, or pay the dollar equivalent of, any services required to be
provided pursuant to this Section 3.2(c), including without limitation, all
services required to be provided by Celtrix for the years 1994 through 1997 that
are undelivered as of the effective date of this Amendment No. 1.
IV. Revision of Article 4, Section 4.3(a)
Section 4.3(a) shall be deleted and replaced with the
following:
(a) Royalty Rates. On a per Product (e.g., all wound repair
Products regardless of dosage or formulation comprise a Product) and annual
basis and subject to decrease pursuant to Section 4.3(b), Genzyme shall pay
Celtrix royalties based on one of the following percentages of Net Sales of
Products sold by Genzyme and its Affiliates in a country where the respective
Product is covered by any Valid Claim, beginning with the First Commercial Sale
in such country and continuing until all such Valid Claims have expired:
For Initial and Additional Products:
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(x) [*] on Net Sales [*]; and
(y) [*] on Net Sales [*].
V. Revision of Article 4, Section 4.3(e):
Section 4.3(e) shall be deleted and replaced with the
following:
(e) Third Party Royalties. If any Third Party is entitled to
receive royalties based on Product sales by Genzyme or its Affiliates or
sublicensees, such royalty obligations shall be allocated to Genzyme and shall
be paid directly by Genzyme.
VI. Revision of Article 5, Section 5.1:
Section 5.1 shall be deleted and replaced with the following:
5.1 Pre-Clinical and Clinical Manufacture. Subject to
Genzyme's rights under Section 5.3, Celtrix shall be responsible for the
manufacturing of all of Genzyme's requirements for Product for the conduct of
pre-clinical and Phase I/II clinical testing of Initial Products prior to June
1, 1997, provided that Celtrix possesses the capability to perform such
manufacturing under applicable regulatory standards and that it shall have
adequate capacity to provide the necessary quality and quantity of Product in
the time frames required by Genzyme. The parties shall agree to and implement
customary forecast and order procedures with respect to such Product to be
manufactured by Celtrix. With regard to such Product manufacture, Celtrix's
responsibilities shall include all aspects of the manufacturing process,
including maintenance of manufactured inventory, quality control and shipment of
Product in accordance with orders placed by Genzyme. As compensation for such
manufacturing services, Celtrix shall be entitled to receive payments of its
manufacturing costs, subject to reduction pursuant to Section 3.2(c). Genzyme
acknowledges that Celtrix has fulfilled all of its manufacturing requirements
for Product under this Section 5.1.
ACCEPTED AND AGREED,
Celtrix Pharmaceuticals, Inc. Genzyme Corporation
By: /s/ Andreas Sommer By: /s/ Richard Douglas
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Title: President & CEO Title: V.P. Corporate Development
Date: 12/31/97 Date: 12/18/97