EXHIBIT 10.8
STRYKER
IRREVOCABLE LICENSE AGREEMENT
This Agreement, dated November 20, 1998 by and between Creative
BioMolecules, Inc., a Delaware corporation with its principal office at 00 Xxxxx
Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("CBM") and Stryker Corporation, a
Michigan corporation with its corporate office at 0000 Xxxxxxxxx Xxxx, X.X. Xxx
0000, Xxxxxxxxx, Xxxxxxxx 00000-0000 ("Stryker").
WHEREAS, the patents and patent applications listed on Schedule 1 attached
hereto are owned by CBM; and
WHEREAS, it is the intention of CBM, by this Irrevocable License Agreement,
to grant to Stryker an exclusive license under the Patent Rights Licensed to
Stryker in the Stryker Field (as such terms are defined herein);
NOW, THEREFORE, in consideration of the foregoing and for other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties, intending to be legally bound, hereby agree as
follows:
1. Definitions. As used herein, the following words shall have the
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following meanings:
a. "Patent Rights Licensed to Stryker" shall mean (i) the patents and
applications listed on Schedule 1 attached hereto, (ii) any patent
applications and patents deemed to be Patent Rights Licensed to Stryker
pursuant to Section 4.6 of the Master Agreement, and (iii) all worldwide
counterparts and registrations, continuations, divisions, reissues,
extensions or supplementary protection certificates, continuations-in-part
or additions (but only to the extent such continuations-in-part or
additions claim inventions disclosed as required by 35 U.S.C. (S)112 (CIPs)
or the applicable laws (additions) in the parent application therefor
listed in Schedule 1) with respect thereto, and all patents issuing
therefrom.
b. "Biological Materials" shall mean any biological materials, assays,
substances or reagents, including without limitation transformed or
transfected cells (including any cell expressing an OP Product or an
analog, mutation or heterodimer thereof conceived, made, developed or
reduced to practice as part of the Research Project (as defined in the
Master Agreement)), cell lines, DNA sequences, vectors, host cells,
proteins, antibodies and any fragments or subcellular components thereof.
c. "Bone Diseases" shall mean Osteoporosis, Osteomalacia and Paget's
Disease.
d. "OP" shall mean proteins (or the active sites thereof) or
polypeptides or combinations of proteins and polypeptides which produce an
osteogenic effect.
e. "OP Products" shall mean OP and polyclonal or monoclonal antibodies
of OP and specific inhibitors or inhibitory activities of the osteogenic
effect of OP, which inhibitors or inhibitory activities are found and
identified as such in the course of the Research Project (as defined in the
Second Amended and Restated Research, Development and Supply Agreement,
dated May 17, 1991, between CBM and Stryker, as amended).
f. "OP Devices" shall mean the combination of OP Products with
suitably biocompatible and biodegradable carriers.
g. "Bone Disease Field" shall mean the prevention or treatment of the
Bone Diseases other than (i) by the local application of OP Products and OP
Devices in an insoluble formulation directly on bone or joint tissue for
local, as opposed to general or systemic, effect and (ii) the treatment of
fractures regardless of whether they result from a Bone Disease.
h. "Creative Manufacturing Know-How" means all inventions, know-how,
Biological Materials (including, without limitation, any cell line
expressing an analog of OP-1 conceived, made, developed or reduced to
practice as part of the Current Scope(s)
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of Work conducted pursuant to Section 4.2 of the Master Agreement),
designs, trade secrets, copyrights, processes, formulas, techniques,
discoveries, ideas and the like that, as of the Closing Date (as defined in
the Master Agreement), are owned by CBM or as to which CBM has acquired
rights which are licensable hereunder, that are necessary or useful in the
manufacture OP Products or OP Devices.
i. "Stryker Field" shall mean the field of (i) treatment, repair or
replacement of bone and joint tissue, including, without limitation,
meniscus and articular cartilage and ligaments and tendons, but excluding
the Bone Disease Field, and (ii) treatment, repair or replacement of the
tooth, dentin, alveolar bone, cementum, enamel, gingiva (to the extent, but
only to the extent, the gingiva functions as part of the apparatus holding
the tooth to the jaw) and/or periodontal ligament, but excluding the
treatment of Oral Ulcerations (as defined below) or any other disease or
disorder of the tissues of the mouth not involving the tooth, dentin, bone
(including alveolar bone), cementum, enamel, gingiva (to the extent, but
only to the extent, the gingiva functions as part of the apparatus holding
the tooth to the jaw), ligament (including the periodontal ligament),
tendon and/or cartilage.
As used herein, "Oral Ulcerations" means the formation of lesions on
the surface of skin lining the oral cavity caused by loss of tissue but
does not include Periodontal Disease (as defined below) or any other
disease or disorder involving the tooth, dentin, bone (including alveolar
bone), cementum, enamel, gingiva (to the extent, but only to the extent,
the gingiva functions as part of the apparatus holding the tooth to the
jaw), ligament (including the periodontal ligament), tendon and/or
cartilage.
As used herein, "Periodontal Disease" means degeneration of the
apparatus holding the tooth to the jaw involving damage to any or all of
the gingiva (to the extent, but only to the extent, the gingiva functions
as part of the apparatus holding the tooth to the jaw), alveolar bone,
cementum, enamel and periodontal ligament.
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j. "Master Agreement" means the Master Restructuring Agreement dated
October 15, 1998 between Stryker and CBM.
2. Grant of Exclusive License. CBM hereby grants to Stryker an irrevocable,
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exclusive, worldwide license, with the unrestricted right to grant sublicenses,
to all of the Patent Rights Licensed to Stryker solely for the manufacture, use,
importation and sale of OP Products and OP Devices in the Stryker Field, which
grant shall be exclusive, even as to CBM, with respect to the Stryker Field, it
being understood that CBM retains the exclusive right to manufacture, use,
import and sell OP Products and OP Devices for use in all fields other than the
Stryker Field. Such license shall not be terminable by CBM or any successor,
assign or any party claiming through CBM under any circumstances or for any
reason (including, without limitation, any breach or default under any other
agreement between Stryker and CBM).
3. Grant of Non-Exclusive License. CBM hereby grants to Stryker an
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irrevocable, non-exclusive, worldwide license, with the unrestricted right to
grant sublicenses under all Creative Manufacturing Know-How, solely for use (a)
in the manufacture of OP Products and OP Devices for use in the Stryker Field,
(b) in the manufacture of OP Products and OP Devices for Creative and (c) in the
manufacture of proteins or polypeptides (or combinations of proteins or
polypeptides) other than OP.
4. Retained Rights. Notwithstanding Section 2, CBM hereby retains for
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itself the right to use OP Products and OP Devices as research and development
tools for the development of other products and devices for use in the Creative
Field. Nothing in the license granted to Stryker hereunder shall preclude CBM
from engaging in the development, production and sale of products and devices in
the Creative Field.
5. Recording of License. CBM shall record this license in the United
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States Patent and Trademark Office and such other foreign patent offices as
Stryker shall determine to be appropriate.
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6. Miscellaneous.
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a. This Agreement may only be amended by a written instrument signed
by both parties, which makes specific reference to this Agreement.
x. Xxxxxxx may assign this Agreement without the consent of CBM. This
Agreement shall be binding upon and shall inure to the benefit of CBM and
Stryker and their respective successors and assigns.
c. This Agreement is governed by the laws of the State of Delaware.
IN WITNESS WHEREOF, the parties have executed this Agreement under seal as
of the date first above written.
CREATIVE BIOMOLECULES, INC. STRYKER CORPORATION
By: /s/ Xxxxxxx Xxxxxx By: /s/ Xxxx X. Xxxxx
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Title: President and CEO Title: Chairman, President and CEO
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