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EXHIBIT 10.11
CREATIVE BIOMOLECULES, INC. HAS OMITTED FROM THIS EXHIBIT 10.11 PORTIONS OF THE
AGREEMENT FOR WHICH CREATIVE BIOMOLECULES, INC. HAS REQUESTED CONFIDENTIAL
TREATMENT FROM THE SECURITIES AND EXCHANGE COMMISSION. THE PORTIONS OF THE
AGREEMENT FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED ARE MARKED WITH
AN ASTERISK AND SUCH CONFIDENTIAL PORTIONS HAVE BEEN FILED SEPERATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
AMENDMENT AGREEMENT
This agreement by and between CREATIVE BIOMOLECULES, INC., a
Delaware corporation with its office and place of business at ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("CBM"), and STRYKER CORPORATION, a Michigan
corporation with its office and place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇.▇.
▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("Stryker").
WHEREAS, CBM and Stryker are parties to that certain Second Amended
and Restated Research, Development and Supply Agreement, dated as of May 17,
1991, as amended to the date hereof (the "Agreement"), concerning research and
development on OP (capitalized terms used but not defined herein shall have the
meaning provided therefor in the Agreement); and
WHEREAS, CBM and Stryker desire to amend the Agreement in certain
respects as more fully set forth herein, to evidence their agreement that the OP
Field includes the Dental Field (as defined below) and to set forth the terms
and conditions relating to the license by CBM to Stryker of CBM's rights with
respect to certain intellectual property and related commercial rights related
to the Dental Field generally and to certain programs undertaken by CBM in the
Dental Field;
NOW, THEREFORE, in consideration of the foregoing and the agreements
set forth herein and in the Agreement, the parties
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hereto agree that, effective as of the date hereof, the provisions of the
Agreement shall be amended as provided herein.
1. The fifth WHEREAS clause of the Agreement is hereby amended by
deleting it in its entirety and replacing it with the following:
WHEREAS, the parties have agreed that Stryker shall own all right,
title and interest in and to the OP Products and OP Devices which have
resulted from or may be further developed by CBM, its agents or
independent contractors as a result of undertaking the Prior Agreement and
this Agreement or performing the tasks performed thereunder or to be
performed hereunder (the "Research Project"); that Stryker shall be the
exclusive licensee of the Licensed Dental Intellectual Property (as such
term is defined in Section 1.7A(iii) of this Agreement) as provided in
Section 1.7 of this Agreement; and that, pursuant to the terms of that
certain Irrevocable License Agreement, dated as of May 17, 1991 (the
"License"), a copy of which is attached hereto as Exhibit 1, Stryker shall
grant to CBM an irrevocable, exclusive, worldwide license to the Present
Patents and Applications and Future Patents and Applications (as such
terms are defined in Section 1.4B of this Agreement) for all uses and
applications of all inventions claimed therein, except for the
manufacture, use and sale of OP Products and OP Devices for use in the
field of treatment, repair or
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replacement of bone and joint tissue including, without limitation,
meniscus and articular cartilage and ligaments and tendons (the "OP
Field") other than the portion of the OP Field consisting of prevention or
treatment of Osteoporosis, Osteomalacia and Paget's Disease 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 Osteoporosis, Osteomalacia and Paget's Disease
(the "Bone Disease Field"), it being expressly understood and agreed that
the OP Field as defined herein includes the Dental Field (as such term is
defined in Section 1.7A(i) of this Agreement);
2. Paragraph B of Section 1.4 of the Agreement is hereby amended by
deleting it in its entirety and replacing it with the following:
B. Pursuant to the Assignment, dated May 17, 1991 (the "Patent
Assignment"), a copy of which is attached hereto as Exhibit 2, CBM has
assigned to Stryker its entire right, title and interest in the inventions
and improvements disclosed in the U.S., foreign and PCT applications and
patents issuing therefrom that are listed in Schedule A thereto (the
"Present Patents and Applications"). CBM represents to Stryker that the
Present Patents and
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Applications and the patents and applications that have been prosecuted in
Stryker's name during the period from May 17, 1991 to October 31, 1996 as
Future Patents and Applications (as defined below), a list of which is set
forth in Schedule I hereto, constitute all U.S., foreign and PCT
applications and patents in which CBM ever had any right, title and
interest that disclose inventions and improvements related to OP Products
and OP Devices conceived, made, developed or reduced to practice as part
of the Research Project by CBM or any of its personnel or by any third
party under contract to CBM. CBM agrees that all future patent
applications and patents that disclose inventions and improvements related
to OP Products and OP Devices that are conceived, made, developed or
reduced to practice as part of the Research Project by CBM or any of its
personnel or by any third party under contract to CBM and all
continuations, continuations in part, divisions, reissues, additions or
extensions and other patents or applications based in whole or in part on
such patents and applications (the "Future Patents and Applications") in
which CBM has any right, title or interest will be prosecuted in Stryker's
name at Stryker's expense. CBM will prepare and file the applications for
the Future Patents and Applications at no expense to Stryker but only
after review thereof by Stryker and with Stryker's concurrence as to the
form thereof. Issues that arise in
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the course of the prosecution of the Present Patents and Applications and
Future Patents and Applications will be jointly decided by Stryker and
CBM.
3. Paragraph A of Section 1.5 of the Agreement is hereby amended by
adding a new sentence at the end thereof that shall read as follows:
Notwithstanding anything in the foregoing to the contrary, no payments
shall be required to be made by CBM to Stryker in respect of the first *
of Royalties, calculated in the manner provided herein, that would
otherwise be required to be paid hereunder.
4. The first sentence of paragraph A of Section 1.6 of this
Agreement is hereby amended to read in its entirety as follows:
Stryker shall pay to CBM, in U.S. dollars, quarterly royalties equal to *
of Stryker's Net Sales of OP Products and OP Devices for a period of *
years beginning, in the case of OP Products or OP Devices with application
in the OP Field other than the Dental Field, on the date of first
commercial sale of any OP Product or OP Device with such an application
and, in the case of OP Products or OP Devices with application in the
Dental Field, on the date of first commercial sale of any OP Product or OP
Device with such an application.
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5. Article I of the Agreement is hereby amended to add at the end
thereof a new Section 1.7, which shall read in its entirety as follows:
1.7 Agreements Relating to the Dental Field.
A. For purposes of this Agreement, the following terms shall have
the meanings set forth below:
(i) "Dental Field" shall mean the 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 in clause (v)
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;
(ii) "Know-How" shall mean all inventions, discoveries,
confidential or proprietary ideas, concepts and information, research
data, lab notebooks, records relating to preclinical and clinical trials,
manufacturing specifications, methods or processes, formulas, designs,
Master Files, IDE and other submissions to the FDA and other authorities
in connection with regulatory clearances,
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product development data and other trade secrets, other than the Licensed
Patent Rights (as such term is defined in Section 1.7A(iv) of this
Agreement), related to the development of OP Products and OP Devices with
applications in the Dental Field;
(iii) "Licensed Dental Intellectual Property" shall mean the
Know-How and the Licensed Patent Rights;
(iv) "Licensed Patent Rights" shall mean CBM's entire right, title
and interest for the United States and all foreign countries in all
inventions and improvements disclosed in the US, foreign and PCT
applications and patents issuing therefrom that are listed on Schedule II
hereto and in all continuations, continuations in part, divisions,
reissues, additions or extensions thereof and in the future patent
applications and patents referred to in the last sentence of Section 1.7B
of this Agreement;
(v) "Oral Ulcerations" shall mean 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 in clause (vi) 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; and
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(vi) "Periodontal Disease" shall mean 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.
B. CBM hereby grants to Stryker an irrevocable (except as set forth
in Section 3.2), exclusive, worldwide license in the Dental Field to use
and enjoy the Licensed Dental Intellectual Property and related commercial
rights that CBM now has or hereafter acquires arising out of research and
development programs undertaken by CBM, or by third parties and in which
CBM has or acquires any rights, to develop OP Products and OP Devices with
applications in the Dental Field, including, but not limited to, OP
Products and OP Devices for dentin regeneration and the treatment of
periodontal disease and tooth sensitivity. The license granted hereunder
shall include the right to sublicense to third parties not affiliated with
Stryker. CBM represents to Stryker that, as of the date hereof, the
Licensed Patent Rights constitute all US, foreign and PCT applications and
patents in which CBM ever had any right, title and interest that disclose
inventions and improvements related to OP Products and OP Devices with
applications in the Dental Field other than the Present Patents and
Applications and
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the Future Patents and Applications to the extent applicable to the Dental
Field and that the inventions and improvements disclosed in the Licensed
Patent Rights and the other Licensed Dental Intellectual Property were not
conceived, made, developed or reduced to practice as part of the Research
Project. CBM further agrees that all future patent applications and
patents in which it has or acquires any rights that disclose inventions or
improvements related to OP Products and OP Devices that were not
conceived, made, developed or reduced to practice as part of the Research
Project but have applications in the Dental Field as well as applications
outside the Dental Field shall be included in Licensed Patent Rights.
▇. ▇▇▇▇▇▇▇ is hereby given the first right during the term of this
Agreement to ▇▇▇ infringers in the Dental Field of the Licensed Dental
Intellectual Property and to collect and retain all profits and/or damages
or amounts by way of settlement that may be recovered as a result thereof,
whether for the past or for the future, and CBM agrees to permit the use
of its name in all such suits and sign all necessary papers. The expenses
of such suit or suits shall be paid by Stryker, and any and all recoveries
from said suit or settlements thereof shall go to Stryker. Should Stryker
fail to take the necessary steps by litigation or otherwise to stop
infringement in the Dental Field of the
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Licensed Dental Intellectual Property, then CBM may conduct at its own
expense, and with the right to all recoveries, such litigation as it may
deem necessary, provided that CBM has first given a written sixty (60) day
notice to Stryker of its intention to initiate such litigation, and
provided further, that Stryker fails during said sixty (60) days' period
to indicate its willingness to initiate said suggested litigation or fails
to initiate said suggested litigation within four (4) months after said
notice. The party conducting any litigation shall keep the other party
reasonably informed as to all actions in the litigation and the party not
conducting the litigation shall assist and cooperate with the party
conducting the litigation and shall be reimbursed by the conducting party
for the out-of-pocket expenses reasonably incurred by it in connection
with providing such assistance and cooperation.
▇. ▇▇▇▇▇▇▇ agrees to reimburse CBM for its pro rata share of all
costs incurred after August 1, 1996 in the prosecution and defense of the
Licensed Patent Rights, which costs will be prorated by agreement of the
parties based on a good faith estimate of the relative value of the patent
or application inside and outside the Dental Field but, if the parties
cannot otherwise agree, each will bear half the cost. CBM agrees that it
will consult with Stryker with respect to issues that arise in the course
of the
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prosecution of the Licensed Patent Rights and that it will not abandon any
claims related to the Dental Field without the prior written consent of
Stryker.
▇. ▇▇▇▇▇▇▇ acknowledges that certain of the Licensed Patent Rights
are the subject of a Cross-License Agreement entered into among Stryker,
CBM and Genetics Institute, Inc. (for itself and the GPDC Partnership
referred to therein).
F. As part of the consideration for the license of the Licensed
Dental Intellectual Property hereunder, Stryker agrees to pay to CBM, by
wire transfer to the account designated in writing by CBM, the sum of
$500,000.
▇. ▇▇▇▇▇▇▇ agrees that it will employ such reasonable efforts as are
necessary to diligently proceed with research and product development work
with regard to the development of OP Products and OP Devices for dentin
regeneration and the treatment of Periodontal Disease. With respect to
dentin regeneration, Stryker agrees to complete the current clinical
trials and then to evaluate this program. With respect to the treatment of
Periodontal Disease, Stryker agrees to prepare a work plan that
contemplates the commencement of human feasibility studies of such OP
Products and Devices prior to *. Stryker's agreements herein with regard
to the continuation of the programs regarding the development of OP
Products and OP
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Devices for dentin regeneration and the treatment of Periodontal Disease
are subject, however, in each case, to the cessation of such activities at
any time in the event of adverse findings regarding safety or efficacy or
any other matter that in Stryker's judgment adversely affects Stryker's
ability to develop a commercially marketable product therefor. Stryker
also agrees to evaluate the results of CBM's research regarding the
treatment of tooth sensitivity and to make a decision regarding the
resumption of that program. In the event that Stryker determines that the
development of a commercially marketable product for dentin regeneration
or the treatment of Periodontal Disease or tooth sensitivity is not
feasible, Stryker agrees that it will consider entering into a license and
sublicense, which license and sublicense shall not include the right to
grant sublicenses without Stryker's written consent, with CBM or a third
party proposed by CBM that is acceptable to Stryker in its reasonable
discretion with respect to the use and exploitation of the patent rights
of Stryker owned by Stryker pursuant to Section 1.4A of this Agreement and
of the Licensed Dental Intellectual Property insofar as they relate to
dentin regeneration or the treatment of Periodontal Disease or tooth
sensitivity, as the case may be. In exercising its discretion in
determining that a proposed third-party licensee/sublicensee is not
acceptable
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to it, Stryker may take into account, among other things, the economic
terms of any such license and sublicense, the fact that the proposed
third-party licensee/sublicensee is a competitor of Stryker in the OP
Field and the protections against off-label use of products produced by
the proposed third-party licensee/sublicensee that are included in the
proposed terms of any such license and sublicense.
▇. ▇▇▇▇▇▇▇ and CBM agree that the Research Project will be expanded
to cover projects related to the programs to be continued by Stryker with
respect to the development of OP Products and OP Devices for dentin
regeneration and the treatment of Periodontal Disease and tooth
sensitivity, if Stryker determines to proceed with any such program. In
such event, the specific projects on which CBM will work and the maximum
number of full-time equivalents to be allocated to them in any month shall
be determined in advance by one or more written documents (a "Dental Field
Related Current Scope of Work") and the term "Current Scopes of Work," as
defined in paragraph B of Section 1.1 shall include any such Dental Field
Related Current Scope of Work.
▇. ▇▇▇▇▇▇▇ shall reimburse CBM for all expenses incurred by CBM
after July 31, 1996 in connection with research efforts and clinical
trials related to the Dental Field up to an aggregate of $85,000 or such
greater amount as may have been approved in advance by Stryker in writing
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promptly upon receipt of an invoice or invoices therefor that provides
detailed information with respect to the particular expenses for which
reimbursement is sought. Except as set forth in the preceding sentence, it
is expressly understood and agreed that Stryker is not assuming any
obligation or liability incurred or that may be incurred as a result of
the work performed prior to the date hereof by CBM or by third patties
under contract to CBM related to the development of OP Products and OP
Devices with applications in the Dental Field, including, but not limited
to, product liability claims, claims arising out of treatments prior to
the date hereof in connection with preclinical or clinical trials,
including with respect to all patients currently enrolled therein, and
that Stryker is not assuming any obligation or liability of CBM to any
third party under any agreement or understanding related to such
development efforts, whether incurred prior to or on or after the
execution and delivery of this Agreement (collectively, the "Preexisting
CBM Obligations"). CBM agrees to indemnify and hold Stryker harmless from
any and all losses, costs, expenses (including attorneys' fees and
expenses), fees, liabilities and damages sustained or that may be
sustained by Stryker to the extent they arise out of Preexisting CBM
Obligations.
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J. Nothing in this Agreement, including, without limitation, the
acceptance of the license of the Licensed Dental Intellectual Property
pursuant to this Section 1.7, shall constitute a waiver by Stryker of its
right to ownership of any portion of the Licensed Dental Intellectual
Property that is subsequently determined to have been conceived, made,
developed or reduced to practice as part of the Research Project by CBM or
any of its personnel or by any third party under contract to CBM.
▇. ▇▇▇▇▇▇▇ acknowledges that any patent rights owned by Stryker that
arise from any Dental Field Related Current Scope of Work shall be Future
Patents and Applications and shall be covered by the License with respect
to all uses and applications of the inventions claimed therein other than
in the OP Field.
6. The first sentence of subparagraph (iv) of Section 3.2C of the
Agreement shall be amended to read in its entirety as follows:
(iv) if Stryker shall at any time after the date hereof decide not
to proceed, or fail to diligently proceed with its obligations under
Section 1.lE, other than with respect to applications in the Dental Field
that are treated separately in Section 1.7G of this Agreement, and such
failure shall continue for three (3) months after notice from CBM, Stryker
shall
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reassign to CBM all of the rights and licenses otherwise granted to
Stryker under this Agreement and the Patent Assignment.
7. Section 3.5 of the Agreement is hereby amended by adding, at the
end thereof, the following language:
; provided, however, that in the event of any controversy or claim
relating to the provisions of this Agreement pertaining exclusively to
matters arising under Section 1.7 hereof, the arbitration shall take place
in Boston, Massachusetts.
8. The specific amendments of certain provisions of the Agreement
set forth in paragraphs 1, 2, 3, 4, 6 and 7 hereof shall be effective as of the
date hereof and the provisions set forth in paragraph 5 hereof shall be deemed
to be added to Article I of the Agreement effective as of the date hereof.
Except as specifically provided herein, the terms and provisions of the
Agreement shall continue in full force and effect in all respects and are hereby
confirmed by the parties hereto.
9. This Agreement may be executed in counterparts and shall become
effective when one or more counterparts have been signed by each of the parties.
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IN WITNESS WHEREOF, the parties hereto have-executed this Amendment
Agreement as of the 31st day of October, 1996.
CREATIVE BIOMOLECULES, INC. STRYKER CORPORATION
/s/▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ /s/▇▇▇▇ ▇. ▇▇▇▇▇
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▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇
President and Chief Chairman of the Board,
Executive Officer President and Chief
Executive Officer
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SCHEDULE I.
CaseNumber Country Application Number: Filing Date: Patent Number:
*
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SCHEDULE I.
CaseNumber Country Application Number: Filing Date: Patent Number:
*
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SCHEDULE II.
Pending and Issued CBM Patent Filings Relating to Dental Field
**The inventions and improvements in the patent applications and patent(s)
listed herein are licensed only for use in the Dental Field.
CaseNumber Country Application Number: Filing Date: Patent Number:
*
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