[***CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS AGREEMENT
HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISION]
CROSS-LICENSE AGREEMENT
This Agreement (the "Agreement") is entered into as of October 14, 2002
(the "Execution Date") by and between Wyeth (formerly, American Home Products
Corporation) by and through Genetics Institute, L.L.C. (formerly Genetics
Institute, Inc.), a Delaware limited liability company with a business address
at 00 XxxxxxxxxXxxx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("GI") and
MetaMorphix, Inc., a Delaware corporation with a business address at 0000X
Xxxxxxxx Xxxx, Xxxxxx, Xxxxxxxx 00000 ("MetaMorphix"). GI and MetaMorphix may
each be referred to herein individually as a "Party" and collectively as the
"Parties".
WHEREAS, as of December 1, 1994, GI, MetaMorphix and The Xxxxx Xxxxxxx
University ("JHU") entered into that certain Collaboration Agreement (the "1994
Agreement") relating to the discovery, characterization, and development of
factors in the TGF-B Superfamily (referred to by GI as "BMPs" and by MetaMorphix
and JHU as "GDFs,"/as such terms are more fully defined in that Agreement);
WHEREAS, as of January 26, 1999, the Parties and JHU entered into that
certain Amended and Restated Collaboration Agreement (as subsequently amended by
the Sponsored Research Amendments (as defined below), the "1999 Agreement")
relating to the discovery, characterization, and development of factors in the
TGF-B Superfamily (referred to by GI as "BMPs" and by MetaMorphix and JHU as
"GDFs," as such terms are more fully defined in that Agreement), which agreement
supercedes and replaces the 1994 Agreement;
WHEREAS, effective as of January 1, 2001, the Parties and JHU executed
and delivered that certain First Amendment to 1999 Amended and Restated
Collaboration Agreement and, effective as of June 30, 2002, the Parties and JHU
executed and delivered that certain Second Amendment to 1999 Amended and
Restated Collaboration Agreement (collectively, the "Sponsored Research
Amendments") each relating to Additional Sponsored Research at JHU focused
solely upon MetaMorphix Factor GDF-8; and
WHEREAS, the Parties desire to disclose and share freely with each
other Confidential Information regarding MetaMorphix Factor GDF-8 and to expand
the present cross licenses (granted under the 1999 Agreement) between the
Parties in respect, only, to MetaMorphix Factor GDF-8 and all internal and
external research related to such Factor, including, but not limited to, the
June 1, 1998 -- December 31, 2000 Sponsored Research at JHU in accordance with
Section 3.3 of the 1999 Agreement and the postJanuary 1, 2001 Additional
Sponsored Research in accordance with the Sponsored Research Amendments.
NOW THEREFORE, in consideration of the foregoing premises, the mutual
covenants, agreements, representations, and warranties set forth herein and
other good and valuable consideration, the receipt and sufficiency of which is
hereby acknowledged
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by each of the Parties, the Parties hereby covenant, agree, represent, and
warrant as follows:
1. DEFINITIONS.
1.1 EXISTING DEFINITIONS. Unless expressly defined herein, all
capitalized terms used in this Agreement shall have the
meanings assigned to such terms in the 1999 Agreement and are
incorporated herein by reference. For the sake of clarity,
where a capitalized term is defined in both this Agreement and
in the 1999 Agreement, the definition set forth in this
Agreement shall control with respect to the use of such term
in this Agreement, and the definition set forth in the 1999
Agreement shall control with respect to the use of such term
in the 1999 Agreement.
1.2 ADDITIONAL DEFINITIONS. Solely for purposes of this Agreement
(it being understood and agreed that nothing in this Section
1.2 shall be deemed to be an amendment of any provision in the
1999 Agreement), the following capitalized terms shall have
the respective meanings assigned thereto in this Section 1.2:
1.2.1 "CONTROL" OR "CONTROLLED" shall mean with respect to any (i)
item of information, including, without limitation, any GDF-8
KnowHow, or (ii) intellectual property right, the possession
(whether by purchase, assignment or license) by a Party of the
ability to grant to the other Party access and/or a license as
provided herein under such item or right without violating the
terms of any agreement or other arrangements with any Third
Party.
1.2.2 "EFFECTIVE DATE" shall mean the next business day following
the last to occur of: (i) the delivery to each Party of fully
executed counterparts of this Agreement, (ii) a determination
made by GI that a notification of this Agreement is not
required to be made under the HSR Act, and (iii) if
notification of this Agreement is required to be made under
the HSR Act, the expiration or earlier termination of any
notice and waiting period under the HSR Act.
1.2.3 "EXCLUDED PRODUCT" shall mean any GI Excluded Product or any
MetaMorphix Excluded Product.
1.2.4 "GDF-8" shall mean the TGF-(3 Factor known as GDF-8 which
Factor is designated under the 1999 Agreement as a
"MetaMorphix Factor".
1.2.5 "GDF-8 DERIVATIVE PRODUCT" shall mean any
pharmaceuticalproduct which primarily acts as
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(i) an antagonist or agonist of GDF-8 or the GDF-8
receptor,
(ii) a vaccine against GDF-8,
(iii) a modifier of GDF-8 synthesis, or
(iv) a modulator of the GDF-8 signal transduction pathway,
only to the extent that such pharmaceutical product is both
(a) developed or sold for the purposes of modulating the
effects of GDF-8, and (b) is covered by one or more Valid
Claims included within the applicable GDF-8 Patent Rights
licensed under Section 2.1 or Section 2.2 hereof.
1.2.6 "GDF-8 KNOW-HOW" shall mean any unpatented information
specifically relating to GDF-8 produced or otherwise
Controlled by either Party which is reasonably useful,
necessary or required for the other Party and its Affiliates
to manufacture, use and/or sell GDF-8 Licensed Products for
use in the MetaMorphix Field or the GI Field, as applicable,
under this Agreement.
1.2.7 "GDF-8 LICENSED PRODUCT" shall mean any GDF-8 Product or GDF-8
Derivative Product, in each case, other than (i) with respect
to the rights granted to GI hereunder, any MetaMorphix
Excluded Product or (ii) with respect to the rights granted to
MetaMorphix hereunder, any GI Excluded Product.
1.2.8 "GDF-8 PATENT RIGHTS" shall mean, with respect to GDF-8, any
GDF-8 Product, or any GDF-8 Derivative Product (a) all Patents
covering inventions (as such term is defined under United
States Patent Law) which (i) as of the Effective Date are
Controlled by or during the term of this Agreement come into
the Control of either Party, either alone or jointly
(including, without limitation, jointly with JHU pursuant to
the 1994 Agreement or the 1999 Agreement) and (ii) are
reasonably useful, necessary or required for the other Party
and its Affiliates to manufacture, use and/or sell GDF-8
Licensed Products for use in the MetaMorphix Field or the GI
Field, as applicable, and (b) all Patents coming into the
Control of a Party during the term of this Agreement, which,
but for the inclusion of such acquired Patents under this
clause (b), would prevent the other Party and its Affiliates
from practicing under one or more of the Patents included
under clause (a) above.
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1.2.9 "GDF-8 PRODUCT" shall mean GDF-8, including any and all
(i) formulations, mixtures or compositions of GDF-8,
(ii) antibodies targeted against GDF-8,
(iii) receptors for which GDF-8 is a ligand,
(iv) antisense molecules or ribozymes that modulate the IN
VIVO production of GDF-8, and
(v) other products for research, diagnostic or
therapeutic use containing GDF-8 or any of (i)
through (iv) above,
which, or which the manufacture use or sale of which, is
covered by one or more Valid Claims included within the
applicable GDF-8 Patent Rights licensed under Section 2.1 or
Section 2.2 hereof.
1.2.10 "GI EXCLUDED PRODUCT" shall mean any GDF-8 Product or any
GDF-8 Derivative Product which GI selects pursuant to Section
3.3 hereof. A list of those GI Excluded Products that have
been selected by GI as of the Effective Date is attached
hereto as Exhibit 1.2.10.
1.2.11 "GI GDF-8 KNOW-HOW" shall mean that GDF-8 Know-How, other than
the Joint GDF-8 Know-How, which is Controlled by GI or its
Affiliates as of the Effective Date or comes into the Control
of GI or its Affiliates during the term of this Agreement, in
each case other than through the grant of licenses by
MetaMorphix under this Agreement or the 1999 Agreement.
1.2.12 "GI GDF-8 PATENT RIGHTS" shall mean those GDF-8 Patent Rights,
other than the Joint GDF-8 Patent Rights, which are Controlled
by GI or its Affiliates as of the Effective Date or come into
the Control of GI or its Affiliates during the term of this
Agreement, in each case other than through the grant of
licenses by MetaMorphix under this Agreement or the 1999
Agreement. Without limitation of the foregoing, a list of
those GI GDF-8 Patent Rights believed to be existing as of the
Effective Date is attached hereto as Exhibit 1.2.12, PROVIDED,
HOWEVER, that inclusion of any particular Patent on Exhibit
1.2.12 shall not serve as an admission by either Party or
evidence that such Patent was not included in the rights
licensed by GI to MetaMorphix under the 1999 Agreement.
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1.2.13 "GI GDF-8 TECHNOLOGY" shall mean the GI GDF-8 Know-How, the GI
GDF-8 Patent Rights and GI's interest in each of the Joint
GDF-8 Know-How and the Joint GDF-8 Patent Rights.
1.2.14 "HSR ACT" shall mean the Xxxx-Xxxxx-Xxxxxx Antitrust
Improvements Act of 1976, as amended, and the rules and
regulations promulgated thereunder.
1.2.15 "JOINT GDF-8 KNOW-HOW" shall mean that GDF-8 Know-How, which
(a) as of the Effective Date is Controlled by both (i) GI or
its Affiliates and (ii) MetaMorphix or its Affiliates or (b)
during the term of this Agreement, comes into the Control of
both (i) GI or its Affiliates and (ii) MetaMorphix or its
Affiliates, in each case other than through the grant of
licenses by one Party to the other Party under this Agreement
or the 1999 Agreement.
1.2.15 "JOINT GDF-8 PATENT RIGHTS" shall mean those GDF-8 Patent
Rights, which (a) as of the Effective Date is Controlled by
both (i) GI or its Affiliates and (ii) MetaMorphix or its
Affiliates or (b) during the term of this Agreement, come into
the Control of both (i) GI or its Affiliates and (ii)
MetaMorphix or its Affiliates, in each case other than through
the grant of licenses by one Party to the other Party under
this Agreement or the 1999 Agreement. A list of those Joint
GDF-8 Patent Rights existing as of the Effective Date is
attached hereto as Exhibit 1.2.15.
1.2.16 "METAMORPHIX EXCLUDED. PRODUCT" shall mean any GDF-8 Product
or any GDF-8 Derivative Product which MetaMorphix selects
pursuant to Section 3.3 hereof. A list of those MetaMorphix
Excluded Products that have been selected by MetaMorphix as of
the Effective Date is attached hereto as Exhibit 1.2.16
1.2.17 "METAMORPHIX GDF-8 KNOW-HOW" shall mean that GDF-8 Know-How,
other than the Joint GDF-8 Know-How, which is Controlled by
MetaMorphix or its Affiliates as of the Effective Date or
comes into the Control of MetaMorphix or its Affiliates during
the term of this Agreement, in each case other than through
the grant of licenses by GI under this Agreement or the 1999
Agreement.
1.2.18 "METAMORPHIX GDF-8 PATENT RIGHTS" shall mean those GDF-8
Patent Rights, other than the Joint GDF-8 Patent Rights, which
are Controlled by MetaMorphix or its Affiliates as of the
Effective - Date or come into the Control of MetaMorphix or
its Affiliates during the term of this Agreement, in each case
other than through
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the grant of licenses by GI under this Agreement or the 1999
Agreement. Without limitation of the foregoing, a list of
those MetaMorphix GDF-8 Patent Rights believed to be existing
as of the Effective Date is attached hereto as Exhibit 1.2.18,
PROVIDED, HOWEVER, that inclusion of any particular Patent on
Exhibit 1.2.18 shall not serve as an admission by either Party
or evidence that such Patent was not included in the rights
licensed by MetaMorphix to GI under the 1999 Agreement.
1.2.19 "METAMORPHIX GDF-8 TECHNOLOGY" shall mean the MetaMorphix
GDF-8 Know-How, the MetaMorphix GDF-8 Patent Rights and
MetaMorphix's interest in each of the Joint GDF-8 Know-How and
the Joint GDF-8 Patent Rights.
1.2.20 "PRODUCT DEVELOPMENT" with respect to the activities conducted
by or on behalf of a Party, shall mean any and all activities
performed, by or on behalf of such Party, in connection with
the development of any GDF-8 Product or GDF-8 Derivative
Product from the date on which such Party has formally
determined (in such fashion as such determinations are
customarily made with in such Party's organization) to
undertake those preclinical activities necessary to support
the filing of an IND (in the case of GI) or an INAD (in the
case of MetaMorphix) until Regulatory Approval of such GDF-8
Product or GDF-8 Derivative Product is obtained for the
indication under study, including, without limitation, animal
toxicology studies, formulation research and development,
manufacturing research and development and clinical studies.
When used as a verb in such context, "Develop" shall mean to
engage in Product Development.
2. LICENSES AND OPTIONS.
2.1 LICENSES GRANTED TO GI. To the extent not granted to GI under
the 1999 Agreement, and subject to (i) the terms and
conditions of this Agreement, (ii) the reservation of rights
set forth in Section 6.6 of the 1999 Agreement and (iii) any
rights retained by the United States government in accordance
with P.L. 96-517, as amended by P.L. 98-620, MetaMorphix
hereby grants to GI and its designated Affiliates which agree
in writing to comply with the terms and conditions of this
-Agreement (with a copy of such written agreement being
provided to MetaMorphix) an exclusive, royalty-bearing license
under the MetaMorphix GDF-8 Technology, including the right to
grant sublicenses, (i) to make, have made, use, import,
market, offer for sale and sell GDF-8 Licensed Products in the
Territory, in each case only for use solely in the GI Field
and (ii) to make, have made and use GDF-8 Licensed Products
and MetaMorphix Excluded Products for GI's and/or its
designated
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Affiliates' internal research and development purposes
(PROVIDED, HOWEVER, that no MetaMorphix Excluded Product may
be the subject of a GI animal or clinical study without the
express prior written consent of MetaMorphix, which may be
withheld in its sole discretion). The license granted pursuant
to this Section 2.1 shall continue in effect until the
expiration of the last of the GDF-8 Patent Rights containing a
Valid Claim licensed to GI under this Section 2.1, PROVIDED,
HOWEVER, that thereafter, GI shall have a fully-paid, royalty
free, perpetual, irrevocable non-exclusive license to use the
MetaMorphix GDF-8 Know-How for any and all research,
development and commercialization purposes.
2.2 LICENSES GRANTED TO METAMORPHIX. To the extent not granted to
MetaMorphix under the 1999 Agreement, and subject to (i) the
terms and conditions of this Agreement, (ii) the reservation
of rights set forth in Section 6.6 of the 1999 Agreement and
(iii) any rights retained by the United States government in
accordance with P.L. 96-517, as amended by P.L. 98-620, GI
hereby grants to MetaMorphix and its designated Affiliates
which agree in writing to comply with the terms and conditions
of this Agreement (with a copy of such written agreement being
provided to GI) an exclusive (exclusive, even as to GI),
royalty-bearing license under the GI GDF-8 Technology,
including the right to grant sublicenses, (i) to make, have
made, use, import, market, offer for sale and sell GDF-8
Licensed Products in the Territory, in each case only for use
solely in the MetaMorphix Field and (ii) to make, have made
and use GDF-8 Licensed Products and GI Excluded Products for
MetaMorphix's and/or its designated Affiliates' internal
research and development purposes (PROVIDED, HOWEVER, that no
GI Excluded Product may be the subject of a MetaMorphix animal
or clinical study without the express prior written consent of
GI, which may be withheld in its sole discretion). The license
granted pursuant to this Section 2.2 shall continue in effect
until the expiration of the last of the GDF-8 Patent Rights
containing a Valid Claim licensed to MetaMorphix under this
Section 2.1, PROVIDED, HOWEVER, that thereafter, MetaMorphix
shall have a fully-paid, royalty free, perpetual, irrevocable
non-exclusive license to use the GI GDF8 Know-How for any and
all research, development and commercialization purposes.
2.3 OPTION FOR CERTAIN EXCLUDED PRODUCTS. In the event that either
GI or MetaMorphix develops or otherwise acquires rights to any
Excluded Product and such Party determines, in its sole
reasonable business judgment, that the inclusion by it of such
Excluded Product within the license granted under Section 2.1
or Section 2.2, as the case may be, would not interfere with
its product development and/or commercialization of such
Excluded Product, such Party (the "Offering Party") agrees to
extend to the other Party, by written notice, the opportunity
to negotiate a royalty-bearing license to such Excluded
Product, which license would (a) be restricted to the GI Field
or the
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MetaMorphix Field, as applicable, (b) provide for such
royalties, reports, and records as are set forth in Section 4
herein (and otherwise incorporate the provisions of Sections
9, 10, and 11), and (c) may provide for reasonable parameters
for clinical testing, regulatory approaches, and labeling
requirements. Within thirty (30) days of receiving such
notice, such other Party may elect to negotiate such an
agreement (which shall become an amendment of this Agreement)
by providing the Offering Party written notice of such
election, in which event the Parties would promptly commence
good faith negotiations of the license terms (as provided in
this Section 2.3). If MetaMorphix and GI are unable to agree
on the terms and conditions of such a license within ninety
(90) days after the Offering Party receives such notice from
the other Party, the Offering Party shall thereafter not be
free to grant such rights and licenses to any Third Party.
This Section 2.3 is intended to amend and replace Section 6.9
of the 1999 Agreement with respect to the rights and
obligations conferred upon GI and MetaMorphix thereunder and,
as such, this Section 2.3 shall govern and control with
respect to both this Agreement and the 1999 Agreement.
2.4 RIGHTS LICENSED FROM THIRD PARTIES. In the event that the
license to MetaMorphix or GI under Sections 2.1 or 2.2
includes rights acquired by the licensor Party from a Third
Party (other than from JHU pursuant to the 1999 Agreement)
which involve the payment of royalties, fees or other payments
to such Third Party, the licensor Party shall notify the
licensee Party of the obligation to make such payment(s). The
licensee Party promptly shall elect in writing whether to
exclude such Third Party rights from the licenses granted to
it under this Agreement, and if the licensee Party fails to
exclude such rights, it shall be fully responsible for the
payment of any such royalties, fees and other payments to such
Third Party as a result of its practice of the licenses
granted to it hereunder.
2.5 NONCOMPETE.
2.5.1 BY METAMORPHIX. MetaMorphix and GI agree that, for so
long as the licenses granted to GI, under Section
2.1, with respect to the Product Development and
commercialization of GDF-8 Licensed Products, remain
in effect, MetaMorphix will not sell or otherwise
distribute any GDF-8 Product or GDF-8 Derivative
Product for use in the GI Field. The preceding
sentence shall not apply to any products that
MetaMorphix obtains, other than through the grant of
rights under the 1999 Agreement, from a Third Party
who has developed (or obtained from another Third
Party who has developed) such products without
infringing issued patents of GI included within the
GI GDF-8 Patent Rights under this Agreement, which
products were fully developed by or on behalf of such
Third Party without the use of any of the GI GDF-8
Know-How or any Confidential Information of GI. GI's
right to enforce this Section 2.5.1 shall not
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be assignable, except to its Affiliates. This Section
2.5.1 is not intended as an amendment of Section
6.8.1 of the 1999 Agreement but, rather, confers
rights and obligations in addition to those set forth
in Section 6.8.1 of the 1999 Agreement.
2.5.2 BY GI. GI and MetaMorphix agree that, for so long as
the licenses granted to MetaMorphix, under Section
2.2, with respect to the Product Development and
commercialization of GDF-8 Licensed Products, remain
in effect, GI will not sell or otherwise distribute
any GDF-8 Product or GDF-8 Derivative Product for use
in the MetaMorphix Field. The preceding sentence
shall not apply to any products that GI obtains,
other than through the grant of rights under the 1999
Agreement, from a Third Party who has developed (or
obtained from another Third Party who has developed)
such products without infringing issued patents
included within the MetaMorphix GDF-8 Patent Rights
under this Agreement, which products were fully
developed by or on behalf of such Third Party without
the use of any of the MetaMorphix Know-How or any
Confidential Information of MetaMorphix.
MetaMorphix's right to enforce this Section 2.5.2
shall not be assignable, except to its Affiliates.
This Section 2.5.2 is not intended as an amendment of
Section 6.8.2 of the 1999 Agreement but, rather,
confers rights and obligations in addition to those
set forth in Section 6.8.2 of the 1999 Agreement.
2.6 HSR FILING AND APPROVALS.
2.6.1 HSR FILING. As soon as practicable (consistent with
each Party's procedures for doing so, each of Wyeth
and MetaMorphix shall determine, in its respective
reasonable judgment, whether any filings are required
under the HSR Act and shall notify the other Party of
the determination so made. In the event either Party
determines that such filings should be made, each of
MetaMorphix and GI shall file, as soon as practicable
thereafter, with the Federal Trade Commission (the
"FTC") and the Antitrust Division of the United
States Department of Justice (the "Antitrust
Division") the notification and report form (the
"Report") required under the HSR Act with respect to
the transactions as contemplated hereby and shall
reasonably cooperate with the other Party to the
extent necessary to assist the other Party in the
preparation of its Report and to proceed to obtain
necessary approvals under the HSR Act, including but
not limited to the expiration or earlier termination
of any and all applicable waiting periods required by
the HSR Act. The Parties shall share equally in any
fees required to be paid to any governmental agency
in connection with making such filings and each Party
shall bear its own expenses, including, without
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limitation, legal fees, incurred in connection with
preparing such filings.
2.6.2 METAMORPHIX'S AND GI'S OBLIGATIONS. Each of
MetaMorphix and GI shall use its good faith efforts
to eliminate any concern on the part of any court or
government authority regarding the legality of the
proposed transaction, including, if required by
federal or state antitrust authorities, promptly
taking all steps to secure government antitrust
clearance, including, without limitation, cooperating
in good faith with any government investigation
including the prompt production of documents and
information demanded by a second request for
documents and of witnesses if requested.
2.6.3 ADDITIONAL APPROVALS. MetaMorphix and GI will
cooperate and use respectively all reasonable efforts
to make all other registrations, filings and
applications, to give all notices and to obtain as
soon as practicable all governmental or other
consents, transfers, approvals, orders,
qualifications authorizations, permits and waivers,
if any, and to do all other things necessary or
desirable for the consummation of the transactions as
contemplated hereby. Neither Party shall be required,
however, to divest products or assets or materially
change its business if doing so is a condition of
obtaining approval under the HSR Act or other
governmental approvals of the transactions
contemplated by this Agreement.
3. INFORMATION DISCLOSURE; EXCLUDED PRODUCTS.
3.1 RESEARCH MANAGEMENT COMMITTEE. Within thirty (30) days of the
Effective Date, the Parties shall reestablish a Research
Management Committee ("RMC") consisting of an equal number of
between two (2) and four (4) representatives of each Party.
The sole functions of the RMC shall be to facilitate the
exchange of ideas and information by GI and MetaMorphix under
this Agreement. The RMC shall have no right to amend any
provision of this Agreement. The RMC shall meet at least once
during each calendar half-year (or more or less often as a
majority of the members of the RMC may agree) during the term
of this Agreement. Meetings of the RMC shall alternate between
GI and MetaMorphix locations, provided that such meetings may
also be held telephonically or by videoconference as
determined by the members of the RMC.
3.2 INFORMATION DISCLOSURE. Each of GI and MetaMorphix shall use
its Commercially Reasonable Efforts to disclose, via exchange
of information at
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meetings of the RMC and provision of reports (if and as
available), to the other Party, a summary of those GDF-8
Patent Rights and GDF-8 Know-How that has come into such
Party's Control and has not been previously disclosed to the
other Party. Upon important discoveries or advances being
made, such Party shall endeavor to disclose such new
information prior to the next meeting of the RMC.
Notwithstanding the foregoing, it shall not be a breach of
this Agreement, if a Party has used its good faith
Commercially Reasonable Efforts to disclose such GDF-8
Know-How but has failed to disclose all such GDF-8 Know-How to
the other Party (provided that, upon request by the receiving
Party or awareness of the disclosing Party, such undisclosed
information is then promptly disclosed). From time to time,
upon request, a disclosing Party shall endeavor, but not be
obligated to provide the receiving Party with sample
quantities of proteins and other materials to assist the
receiving Party in its assessment of the disclosed
Confidential Information. Any GDF-8 Know-How disclosed or
materials provided by a Party pursuant to this Section 3.2 or
otherwise to the other Party shall be treated as Confidential
Information of the disclosing Party in accordance with Article
7 hereof.
3.3 EXCLUDED PRODUCTS. From time to time, each Party may, in good
faith and by written notice to the other Party, designate
certain GDF-8 Products and GDF-8 Derivative Products (other
than, (i) in the case of GI making a designation, GDF-8
Products or GDF-8 Derivative Products consisting of compounds
or compositions where such compounds or compositions are
Controlled by MetaMorphix and are initially provided to GI by
MetaMorphix under this Agreement or the 1999 Agreement and
(ii) in the case of MetaMorphix making a designation, GDF-8
Products or GDF-8 Derivative Products consisting of compounds
or compositions where such compounds or compositions are
Controlled by GI and are initially provided to MetaMorphix by
GI under this Agreement or the 1999 Agreement), as either GI
Excluded Products or MetaMorphix Excluded Products, as
applicable. Such notice shall detail the rationale for such
designation. A Party may designate a GDF-8 Product or a GDF-8
Derivative Product as either a GI Excluded Product or a
MetaMorphix Excluded Product only if such Party (upon
successful, in vivo, proof of concept) has initiated Product
Development of such GDF-8 Product or GDF-8 Derivative Product,
PROVIDED, HOWEVER, that upon designating any GDF-8 Product or
GDF-8 Derivative Product as an Excluded Product, the
designating Party may also designate as Excluded Products, a
reasonable number of other GDF-8 Products or GDF-8 Derivative
Products (as the case may be), which GDF-8 Products or GDF-8
Derivative Products not only are in the same chemical class or
biological class as the GDF-8 Product or GDF- Derivative
Product primarily selected as an Excluded Product, but also
are intended be back-up candidates (to the extent customary in
the pharmaceutical industry) for the primarily selected
Excluded Product. For the sake of clarity, a Party may not
designate a broad category of GDF-8 Products or GDF-8
Derivative
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Products (e.g., all antibodies, or all compounds of a
particular chemical class, or a biological class) as Excluded
Products, merely because such Party has initiated Product
Development of a GDF-8 Product or a GDF-8 Derivative Product
within such category. A designated Excluded Product shall be
only an active ingredient or a single molecule. Except to the
extent provided otherwise in Section 2.4 above, during the
term of this Agreement, MetaMorphix shall not develop or
commercialize any GI Excluded Product in the MetaMorphix Field
and GI shall not develop or commercialize any MetaMorphix
Excluded Product in the GI Field.
4. ROYALTIES.
4.1 PAYABLE BY GI. GI shall pay to MetaMorphix, on a country by
country basis, a royalty in the amount of two percent (2%) of
the Net Sales of each GDF-8 Licensed Product sold in such
country by or on behalf of GI, its Affiliates or sublicensees
(other than MetaMorphix) pursuant to the licenses granted by
MetaMorphix to GI hereunder. Such royalties shall be payable,
on a country by country basis, for so long as the manufacture,
use or sale of such GDF-8 Licensed Product in such country
would, but for the licenses granted by MetaMorphix to GI
hereunder, infringe a Valid Claim of a patent included within
the MetaMorphix GDF-8 Patent Rights or the Joint GDF-8 Patent
Rights licensed by MetaMorphix to GI hereunder and shall be
incremental to any royalty payable under the 1999 Agreement,
PROVIDED, HOWEVER, that the grant of rights under this
Agreement shall not serve to extend the period of time during
which royalties are payable under the 1999 Agreement.
4.2 PAYABLE BY METAMORPHIX. MetaMorphix shall pay to GI, on a
country by country basis, a royalty in the amount of two
percent (2%) of the Net Sales of each GDF-8 Licensed Product
sold in such country by or on behalf of MetaMorphix, its
Affiliates or sublicensees (other than GI) pursuant to the
licenses granted by GI to MetaMorphix hereunder. Such
royalties shall be payable, on a country by country basis, for
so long as the manufacture, use or sale of such GDF-8 Licensed
Product in such country would, but for the licenses granted by
GI to MetaMorphix hereunder, infringe a Valid Claim of a
patent included within the GI GDF-8 Patent Rights or the Joint
GDF-8 Patent Rights licensed by GI to MetaMorphix hereunder
and shall be incremental to any royalty payable under the 1999
Agreement, PROVIDED, HOWEVER, that the grant of rights under
this Agreement shall not serve to extend the period of time
during which royalties are payable under the 1999 Agreement.
CONFIDENTIAL -12-
4.3 ROYALTY CALCULATIONS.
4.3.1 COUNTRY-BY-COUNTRY BASIS. For each GDF-8 Licensed
Product, royalties shall be payable by a Party on a
country-by-country basis solely with respect to Net
Sales for any country where such GDF-8 Licensed
Product is manufactured or sold in which there is a
Valid Claim under the applicable GDF-8 Patent Rights.
However, for sales of a GDF-8 Licensed Product which
is manufactured in a country in which there is a
Valid Claim under the applicable GDF-8 Patent Rights,
but sold in a country where there is no existing
Valid Claim under the applicable GDF-8 Patent Rights,
the royalties payable hereunder by the Parties for
sales in that country shall be reduced by fifty
percent (50%) if products are being sold in that
country which directly compete with such GDF-8
Licensed Product.
4.3.2 ADVANCED PRODUCTS. For GDF-8 Licensed Products which
are not finished formulations, mixtures or
compositions of GDF-8 (that is, for GDF-8 Licensed
Products which could not have been developed by a
Party but for the application of substantial advanced
technologies developed by that Party (including,
without limitation, GDF-8 Licensed Products which are
antibodies, antisense molecules or ribozymes to,
GDF-8), the royalty payable hereunder by that
developing Party on Net Sales of that GDF-8 Licensed
Product shall be reduced to reflect the fair market
value contribution of that advanced technology to the
GDF-8 Licensed Product, as determined by mutual
agreement of the Parties. In the event that the
Parties are unable to calculate or agree upon the
fair market value contribution of the advanced
technology to the GDF-8 Licensed Product, then the
royalty payable by the developing Party on Net Sales
of that GDF-8 Licensed Product shall be reduced by
fifty percent (50%).
4.3.3 THIRD PARTY ROYALTIES. If it becomes necessary, in
order for a Party or its Affiliates or sublicensees
to make, use or sell any GDF-8 Licensed Product, to
pay royalties under a Third Party's patent rights
(including amounts, if any, payable to Third Parties
under Section 2.4, above; and with respect to
MetaMorphix, excluding amount payable by MetaMorphix
to GI under this Agreement or to JHU and/or GI under
the 1999 Agreement; and with respect to GI, excluding
amount payable by GI to MetaMorphix under this
Agreement or to MetaMorphix and/or JHU under the 1999
Agreement), then the licensee Party shall have the
right to deduct fifty percent (50%) of the amounts so
paid to Third Parties up to a total of fifty percent
(50%) of the amount due hereunder to the licensor
Party on account of such particular GDF-8 Licensed
Product.
CONFIDENTIAL -13-
4.3.4 LIMITATION ON ROYALTY DEDUCTIONS. Total royalty
deductions under this Section 4.3 shall not exceed
fifty percent (50%) of the amount due the licensor
Party on account of Net Sales of the GDF-8 Licensed
Product, for which royalty payments are owed.
4.4 REPORTS AND PAYMENT. Each Party shall deliver to the Party to
which royalties are owed hereunder, within sixty (60) days
after the end of each calendar quarter, a written report
showing its computation of royalties due under this Agreement
upon Net Sales by such Party, its Affiliates and sublicensees
during such calendar quarter. All Net Sales shall be segmented
in each such report according to sales by such Party, each
Affiliate and each sublicensee, as well as on a
country-by-country basis, including the rates of exchange used
to convert such royalties to United States Dollars from the
currency in which such sales were made. Subject to the
provisions of Sections 4.5 and 4.6 of this Agreement,
simultaneously with the delivery of each such report, the
paying Party shall tender payment in United States Dollars of
all royalties shown to be due therein. Such reports may be
combined with any report to be submitted by such Party to the
other Party pursuant to the 1999 Agreement, provided, that
such combined report separately states the amounts payable
under the 1999 Agreement and the amounts payable under this
Agreement. For purposes hereof, the rates of exchange to be
used for converting royalties hereunder to United States
Dollars shall be the closing price published for the purchase
of United States Dollars in the East Coast Edition of the Wall
Street Journal for the last business day of the calendar
quarter for which payment is due.
4.5 FOREIGN ROYALTIES. Where royalties are due hereunder for sales
of GDF-8 Licensed Products in a country where, by reason of
currency regulations or taxes of any kind, it is impossible or
illegal for such Party, any Affiliate or sublicensee to
transfer royalty payments to the licensor Party for Net Sales
in that country, such royalties shall be deposited in whatever
currency is allowable by the person or entity not able to make
the transfer for the benefit or credit of the licensor Party
in an accredited bank in that country that is reasonably
acceptable to the licensor Party.
4.6 TAXES. Any and all income or similar taxes imposed or levied
on account of the receipt of royalties payable under this
Agreement which are required to be withheld by a Party shall
be paid by such Party, its Affiliates or sublicensees on
behalf of the licensor Party and shall be paid to the proper
taxing authority. Proof of payment shall be secured and sent
to the licensor Party by such Party, its Affiliates or
sublicensees as evidence of such payment in such form as
required by the tax authorities having jurisdiction over such
Party, its Affiliates or sublicensees. Such taxes shall be
deducted from the royalty that would otherwise be remittable
hereunder by the Party, its Affiliates or sublicensees.
CONFIDENTIAL -14-
4.7 RECORDS. Each Party shall keep, and shall require all
Affiliates and sublicensees to keep, for a period of at least
two (2) years, full, true and accurate books of accounts and
other records containing all information and data which may be
necessary to ascertain and verify the royalties payable by
such Party hereunder. During the term of this Agreement and
for a period of two (2) years following its termination, each
Party shall have the right from time to time (not to exceed
once during each calendar year) to inspect in confidence, or
have an agent, accountant or other representative inspect in
confidence, such books, records and supporting data.
5. PRODUCT DEVELOPMENT AND COMMERCIALIZATION.
5.1 DILIGENCE OBLIGATIONS. GI and MetaMorphix each shall have no
diligence obligations with respect to the Product Development
or commercialization of any GDF-8 Licensed Product over and
above those set forth in the 1999 Agreement.
6. PATENT PROSECUTION AND INFRINGEMENT.
6.1 RESPONSIBILITY FOR PATENTING GDF-8 PATENT RIGHTS.
6.1.1 GI GDF-8 PATENT RIGHTS AND CERTAIN JOINT GDF-8 PATENT
RIGHTS. Subject to the rights and obligations of each
of the Parties and JHU under the 1999 Agreement, GI
shall have the first right, but not the obligation,
to seek or continue to seek or maintain Patent
protection on any GI GDF-8 Patent Rights and any
Joint GDF-8 Patent Rights, in any country. If GI
elects, in any country not to seek or continue to
seek or maintain Patent protection on any such GDF-8
Patent Rights, to the extent the manufacture use or
sale, by MetaMorphix, of a GDF-8 Licensed Product
would infringe such GDF-8 Patent Rights in such
country, MetaMorphix shall have the right, but not
the obligation, at its expense, to file, procure and
maintain in such country(ies) such GDF-8 Patent
Rights.
6.1.2 METAMORPHIX GDF-8 PATENT RIGHTS. Subject to the
rights and obligations of the Parties and JHU under
the 1999 Agreement, MetaMorphix shall have the first
right, but not the obligation, to seek or continue to
seek - or maintain Patent protection on any
MetaMorphix GDF-8 Patent Rights in any country. If
MetaMorphix elects not to seek or continue to seek or
maintain Patent protection on any MetaMorphix GDF-8
Patent Rights in any country, GI shall have the
right, but not the obligation, at its expense, to
file, procure and maintain in such country(ies) such
MetaMorphix GDF-8 Patent Rights.
CONFIDENTIAL -15-
6.1.3 PATENT COOPERATION. Each Party shall advise the other
Party of all decisions taken under this Section 6.1
in a timely manner in order to allow the other Party
to protect its rights under this Section 6.1. Each
Party shall provide the other Party with copies of
all substantive communications from all patent
offices regarding any GDF-8 Patent Rights, promptly
after the receipt thereof. Each Party shall provide
the other Party with copies of all proposed
substantive communications to such patent offices
regarding the GDF-8 Patent Rights in sufficient time
before the due date in order to enable the other
applicable Party an opportunity to comment on the
content thereof. Each Party shall make available to
the other Party, or its authorized attorneys, agents
or representatives, such of its employees whom the
other applicable Party, in its reasonable judgment,
deems necessary in order to assist it in obtaining
Patent protection for the applicable GDF-8 Patent
Rights, in the event the Party with first rights to
seek or continue to seek or maintain Patent
protection on any such GDF-8Patent Rights chooses not
to do so. Each Party shall sign or use its best
efforts to have signed all legal documents necessary
to file and prosecute Patents or to obtain or
maintain Patents at no cost to the other Party. Each
Party shall bear all costs incurred by it in
exercising the foregoing rights.
6.1.4 INTERFERENCES. The Parties shall each, in good faith,
use its respective Commercially Reasonable Efforts to
resolve any patent interferences between any of the
Parties relating to Patents directed to GDF-8 or any
GDF-8 Licensed Product.
6.2 INFRINGEMENT.
6.2.1 NOTICE. Each Party shall promptly report in writing
to the other Party during the term of this Agreement
any (i) known infringement or suspected infringement
of any of the GDF-8 Patent Rights or (ii)
unauthorized use or misappropriation of the other
Party's Confidential Information by a Third Party of
which it becomes aware, and shall provide the other
Parties with all available evidence supporting said
infringement, suspected infringement or unauthorized
use or misappropriation.
6.2.2 FIRST RIGHT TO INITIATE SUITS. Subject to the rights
and obligations of the Parties under the 1999
Agreement, MetaMorphix shall have the first right to
initiate an infringement or other appropriate suit
against any Third Party who at any time has
infringed, or is suspected of infringing, any of the
MetaMorphix GDF-8 Patent Rights licensed to GI
hereunder or of using without proper authorization
all or any of MetaMorphix's Confidential Information,
where such infringement,
CONFIDENTIAL -16-
suspected infringement or unauthorized use is
determined by MetaMorphix to have an adverse affect
on its ability to make, have made, use and/or sell
GDF-8 Licensed Products, PROVIDED, HOWEVER, that GI
shall have the first right to initiate such
infringement or other appropriate suit against any
such Third Party, where the actual or suspected
infringement is occurring only in the GI Field. GI
shall have the first right to initiate an
infringement or other appropriate suit against any
Third Party who at any time has infringed, or is
suspected of infringing, any of the GI GDF-8 Patent
Rights licensed to MetaMorphix hereunder or the Joint
GDF-8 Patent Rights, or of using without proper
authorization all or any of GI's Confidential
Information, where such infringement, suspected
infringement or unauthorized use is determined by GI
to have an adverse affect on its ability to make,
have made, use and/or sell GDF-8 Licensed Products.
GI and MetaMorphix agree to consult with each other
prior to instituting any such suit and to provide the
other Party a reasonable opportunity to participate,
at its own expense, in any such suit to protect its
respective interests.
6.2.3 RIGHT TO PARTICIPATE IN SUIT. The Party initiating a
suit pursuant to Section 6.2.2 above (the "first
Party") shall give the other Party (the "second
Party") sufficient advance notice of its intent to
file said suit and the reasons therefor, and shall
provide the second Party with an opportunity to make
suggestions and comments regarding such suit,
including, without limitation, the initiation thereof
and the selection of counsel therefor. The first
Party shall keep the second Party promptly informed,
and shall from time to time consult with the second
Party regarding the status of any such suit and shall
provide the second Party with copies of all documents
filed in, and all written communications relating to,
such suit. Except as provided herein, the first Party
shall have the sole and exclusive right to select
counsel for any suit and shall pay all expenses of
the suit, including without limitation attorneys'
fees and court costs. The second Party, in its sole
discretion, may elect, within sixty (60) days after
the commencement of such litigation, to contribute a
fixed percentage of up to fifty percent (50%) of the
costs incurred by the first Party in connection with
such litigation, including, without limitation,
reimbursement of the first Party's expenses
hereunder. If it so elects, any damages, royalties,
settlement fees or other consideration received by
the first Party or any of its Affiliates for past
infringement or misappropriation as a result of such
litigation shall be shared by the first and second
Parties pro-rata based on their respective sharing of
the costs of such litigation, subject to Section
6.2.5, below. In the event that the second Party
elects not to contribute to the costs of such
litigation, the first Party and/or its Affiliates
shall be entitled to retain any damages, royalties,
settlement
CONFIDENTIAL -17-
fees or other consideration for past infringement or
misappropriation resulting therefrom, subject to
Section 6.2.5, below. If necessary or desirable, the
second Party shall join as a party to the suit but
shall be under no obligation to participate except to
the extent that such participation is required as the
result of being a named party to the suit. The second
Party shall offer reasonable assistance to the first
Party in connection therewith at no charge to the
first Party except for reimbursement of reasonable
out-of-pocket expenses. The second Party shall have
the right to participate and be represented in any
such suit by its own counsel at its own expense. The
first Party shall not settle any such suit involving
rights of the second Party without obtaining the
prior written consent of the second Party, which
consent shall not be unreasonably withheld or
delayed.
6.2.4 SECOND RIGHT TO INITIATE SUIT. In the event that the
first Party elects not to initiate an infringement or
other appropriate suit pursuant to Sections 6.2.2,
above, as applicable, the first Party shall promptly
advise the second Party of its intent not to initiate
such suit, and the second Party shall have the right,
at its expense, of initiating an infringement or
other appropriate suit against any Third Party who at
any time has infringed, or is suspected of
infringing, any of the GDF8 Patent Rights or of using
without proper authorization all or any portion of
such Party's Confidential Information. In exercising
its rights pursuant to this Section 6. 2. 4, the
second Party shall have the sole and exclusive right
to select counsel and shall, except as provided
below, pay all expenses of the suit including without
limitation attorneys' fees and court costs. The first
Party, in its sole discretion, may elect, within
sixty (60) days after the commencement of such
litigation, to contribute a fixed percentage of up to
fifty percent (50%) of the costs incurred by the
second Party in connection with such litigation,
including, without limitation, reimbursement of the
second Party's expenses hereunder. If it so elects,
any damages, royalties, settlement fees or other
consideration received by the second Party or any of
its Affiliates for past infringement or
misappropriation as a result of such litigation shall
be shared by the second and first Parties pro-rata
based on their respective sharing of the costs of
such litigation, subject to Section 6. 2. 5, below.
In the event that the first Party elects not to
contribute to the costs of such litigation, the
second Party and/or its Affiliates shall be entitled
to retain any damages, royalties, settlement fees or
other consideration for past infringement or
misappropriation resulting therefrom, subject to
Section 6.2.5, below. If necessary or desirable, the
first Party shall join as a party to the suit but
shall be under no obligation to participate except to
the extent that such participation is required as a
result of being a named party to the suit. At the
second Party's request, the first Party shall offer
reasonable assistance to the second
CONFIDENTIAL -18-
Party in connection therewith at no charge to the
second Party except for reimbursement of reasonable
out-of-pocket expenses. The first Party shall have
the right to participate and be represented in any
such suit by its own counsel at its own expense.
6.2.5 ROYALTY DEDUCTION. Any damages, royalties, settlement
fees or other consideration for past infringement or
misappropriation awarded to and/or collected by a
Party (or Parties) resulting from an infringement or
other appropriate suit against a Third Party or a
settlement thereof shall, after deduction of all
costs and expenses associated with such suit or
settlement, be deemed to reflect a loss of commercial
sales, and royalties shall be payable thereon to the
Party (or Parties) to which royalties would have been
owed under Section 4.1 of this Agreement, provided
that such Party is not otherwise entitled to receive
a portion of any recovery other than reimbursement of
its litigation expenses) obtained from such suit or
settlement pursuant to this Section 6.2.
6.3 CLAIMED INFRINGEMENT.
6.3.1 NOTICE; COOPERATION. In the event that a Third Party
at any time provides written notice of a claim to, or
brings an action, suit or proceeding against, any
Party or any of their respective Affiliates or sub
licensees, claiming infringement of its patent rights
or copyrights or unauthorized use or misappropriation
of its Confidential Information, based upon an
assertion or claim arising out of the manufacture,
use and/or sale of any GDF-8 Product pursuant to the
licenses granted under this Agreement, such Party
shall promptly notify the other Parties of the claim
or the commencement of such action, suit or
proceeding, enclosing a copy of the claim and/or all
papers served. Each Party agrees to make available to
the other Party its advice and counsel regarding the
technical merits of any such claim at no cost to the
other Party.
6.3.2 LIMITATION OF LIABILITY. EXCEPT FOR BREACHES OF
SECTIONS 8.1, 8.2 AND 8.3 OF THIS AGREEMENT, THE
FOREGOING STATES THE ENTIRE RESPONSIBILITY OF THE
PARTIES IN THE CASE OF ANY CLAIMED INFRINGEMENT OR
VIOLATION OF ANY THIRD PARTY'S PATENT RIGHTS OR
COPYRIGHTS OR UNAUTHORIZED USE OR MISAPPROPRIATION OF
ANY THIRD PARTY'S KNOW-HOW.
CONFIDENTIAL -19-
7. CONFIDENTIAL INFORMATION.
7.1 NONDISCLOSURE OF CONFIDENTIAL INFORMATION. Neither Party may
directly or indirectly publish, disseminate or otherwise
disclose, deliver or make available to any person outside its
organization any of the other Party's Confidential Information
received hereunder. Each Party may disclose the other Party's
Confidential Information to persons within its organization
and to its Affiliates and sublicensees who/which have a need
to receive such Confidential Information in order to further
the purposes of this Agreement and who/which are bound to
protect the confidentiality of such Confidential Information,
as set forth in Section 7.3 below. Each Party may disclose the
other Party's Confidential Information to a governmental
authority or by order of a court of competent jurisdiction,
provided that such disclosure is subject to all applicable
governmental or judicial protection available for like
material and reasonable advance notice is given to the other
Party.
7.2 USE OF CONFIDENTIAL INFORMATION. Each Party shall use the
other Party's Confidential Information solely for the purposes
contemplated in this Agreement or for such other purposes as
may be agreed upon by the Parties in writing.
7.3 AGREEMENTS WITH PERSONNEL AND THIRD PARTIES. The Parties have
or shall obtain agreements with all personnel and Third
Parties who will have access to the other Party's Confidential
Information which impose on such personnel and Third Parties
confidentiality and non-use obligations which are no less
restrictive than those that are set forth in this Agreement.
7.4 PUBLICATIONS.
7.4.1 RIGHT TO PUBLISH. Any Party may publish any
manuscripts or other scientific papers on work
conducted exclusively by that Party without the
written consent of the other Parties. However, a
Party may not publish (or permit a Third Party to
publish) any manuscript or other scientific paper
that discloses or uses any Confidential Information
of another Party without first obtaining that other
Party's written consent; and a Party may not publish
any manuscript or other scientific paper that would
prejudice any Patent rights of another Party
(including, without limitation, prospective Patent
rights) without first complying with the provisions
of this Section 7.4 and Section 6.1, above.
7.4.2 NOTICE AND REVIEW. In order to balance the Parties'
interests in securing Patents covering the GDF-8
Patent Rights with each Party's right to publish any
manuscripts or other scientific papers on work
relating directly and exclusively to GDF-8 or GDF-8
Products which work is conducted solely by or on
behalf of that Party, prior to the
CONFIDENTIAL -20-
publication or other public disclosure of any
manuscripts or other form of disclosure describing
the results of its work hereunder, the publishing
Party shall provide (a) the data to be disclosed in
that manuscript or other form of public disclosure to
the other Party as soon as practicable, but at least
four (4) weeks prior to intended submission for
publication or other method of public disclosure, (b)
a copy of the draft manuscript to be published, or a
detailed summary of any other public disclosure to
the other Parties as soon as practicable, but at
least two (2) weeks prior to intended submission for
publication or other method of public disclosure, (c)
a copy of the completed manuscript or other form of
public disclosure at the time of submission and (d) a
copy of any reviewer's comments on the manuscript or
other form of public disclosure with a revised copy
thereof at least two (2) weeks prior to publication.
7.4.3 DELETION OF CONFIDENTIAL INFORMATION; PATENT
PROTECTION. A Party may request that the publishing
Party delete from its manuscripts or other scientific
papers or other forms of public disclosure reference
to that Party's Confidential Information. In
addition, if a Party notifies another Party that it
desires patent applications to be filed claiming
inventions that would be included within the GDF-8
Patent Rights once filed, which patent application
contains information to be disclosed by that other
Party in a public forum other than in manuscripts or
other scientific papers, the presenting Party will
defer such presentation for a period, not to exceed
thirty (30) additional days, sufficient to permit the
Party with rights to file any desired patent
applications to do so.
8. REPRESENTATION AND WARRANTIES.
8.1 REPRESENTATIONS AND WARRANTIES OF GI AND METAMORPHIX. As of the
Effective Date, each of GI and MetaMorphix hereby represents,
warrants and covenants to the other Party hereto as follows:
(a) it is a corporation or entity duly organized and
validly existing under the laws of the state or other
jurisdiction of incorporation or formation;
(b) the execution, delivery and performance of this
Agreement by such Party has been duly authorized by
all requisite corporate action and do not require any
shareholder action or approval;
(c) it has the power and authority to execute and deliver
this Agreement and to perform its obligations
hereunder;
CONFIDENTIAL -21-
(d) the execution, delivery and performance by such Party
of this Agreement and its compliance with the terms
and provisions hereof does not and will not conflict
with or result in a breach of any of the terms and
provisions of or constitute a default under (i) a
loan agreement, guaranty, financing agreement,
agreement affecting a product or other agreement or
instrument binding or affecting it or its property;
(ii) the provisions of its charter or operative
documents or bylaws; or (iii) any order, writ,
injunction or decree of any court or governmental
authority entered against it or by which any of its
property is bound; and
(e) it shall at all times comply with all applicable
material laws and regulations relating to its
activities under this Agreement.
8.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF GI.
8.2.1 PATENT RIGHTS AND KNOW-HOW. To the best of GI's
knowledge, information and belief, GI represents and
warrants that it owns or has exclusive (except to the
extent otherwise provided in the 1999 Agreement)
rights to the GI GDF-8 Patent Rights and GI GDF-8
Know-How in existence on the Effective Date and/or has
the right to grant the licenses under the GI GDF-8
Patent Rights and to the GI GDF-8 Know-How in
existence on the Effective Date subject to the terms
of this Agreement. The foregoing representation and
warranty shall not be construed as a warranty as to
the scope and/or validity of any claims in the GI
GDF-8 Patent Rights.
8.2.2 NO CONFLICTING AGREEMENTS. GI represents and warrants
that the execution of, and performance of the
transactions contemplated by, this Agreement will not
conflict with or result in any breach of any of the
teens, conditions or provisions of, or constitute a
default under, any agreement to which GI is a party or
by which GI is bound.
8.3 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF METAMORPHIX.
8.3.1 PATENT RIGHTS AND KNOW-HOW. To the best of
MetaMorphix' knowledge, information and belief,
MetaMorphix represents and warrants that it owns or
has exclusive (except to the extent otherwise provided
in the 1999 Agreement) rights to the MetaMorphix GDF-8
Patent Rights and MetaMorphix GDF-8 Know-How in
existence on the Effective Date and/or has the right
to grant the licenses under the MetaMorphix GDF-8
Patent Rights and to the MetaMorphix GDF-8 Know-How in
existence on the Effective Date subject to the terms
of this Agreement. The foregoing representation and
warranty shall not be construed as a warranty as to
the scope and/or validity of any claims in the
MetaMorphix GDF-8 Patent Rights.
CONFIDENTIAL -22-
8.3.2 NO CONFLICTING AGREEMENTS. MetaMorphix represents and
warrants that the execution of, and performance of
the transactions contemplated by, this Agreement will
not conflict with or result in any breach of any of
the terms, conditions or provisions of, or constitute
a default under, any agreement to which MetaMorphix
is a party or by which MetaMorphix is bound.
8.4 REPRESENTATION BY LEGAL COUNSEL. Each Party hereto represents
that it has been represented by legal counsel in connection
with this Agreement and acknowledges that it has participated
in the drafting hereof. In interpreting and applying the terms
and provisions of this Agreement, the Parties agree that no
presumption shall exist or be implied against the Party which
drafted such teens and provisions.
8.5 MATERIALITY. EACH PARTY EXPRESSLY WAIVES ANY RIGHTS TO SEEK
DAMAGES OR OTHER RELIEF FOR BREACH OF THE REPRESENTATIONS AND
WARRANTIES IN SECTIONS 8.1, 8.2 AND 8.3 UNLESS SUCH BREACH HAS
A MATERIAL AND ADVERSE EFFECT ON SUCH PARTY.
8.6 DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NO
PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT
NOT LIMITED TO IMPLIED WARRANTIES OR MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
9. PRODUCT LIABILITY INDEMNIFICATION.
9.1 METAMORPHIX INDEMNIFICATION. MetaMorphix agrees to defend GI
and ITS respective Affiliates, sublicensees, agents,
directors, officers, employees, students and licensees of
rights to a GDF-8 Licensed Product, as applicable (the
"indemnitees") (other than in settlement of a claim of
infringement), at MetaMorphix' cost and expense, and will
indemnify and hold harmless such indemnitees from and against
any and all liabilities, losses, costs, damages, fees, or
expenses claimed by or paid to a Third Party attributable to
injury to persons or damage to property (collectively,
"Losses") arising out of or in connection with the
manufacture, use and/or sale of any GDF-8 Licensed Product by
MetaMorphix, its -Affiliates, or sublicensees (other than GI);
provided that such Losses do not arise out of the gross
negligence or willful misconduct of GI or any GI indemnitee.
MetaMorphix's indemnification obligations under this Section
9.1 shall be applicable only to the extent not covered by
MetaMorphix's indemnification obligations under the 1999
Agreement.
CONFIDENTIAL -23-
9.2 GI INDEMNIFICATION. GI agrees to defend MetaMorphix and its
respective Affiliates, permitted sublicensees, agents,
directors, officers, employees, students and licensees of
rights to a GDF-8 Licensed Product, as applicable (the
"indemnitees") (other than in settlement of a claim of
infringement), at GI's cost and expense, and will indemnify
and hold harmless such indemnitees from and against any and
all Losses arising out of or in connection with the
manufacture, use and/or sale of any GDF-8 Licensed Product by
GI, its Affiliates, or sublicensees (other than MetaMorphix);
provided that such Losses do not arise out of the gross
negligence or willful misconduct of MetaMorphix or any
MetaMorphix indemnitee. GI's indemnification obligations under
this Section 9.2 shall be applicable only to the extent not
covered by GI's indemnification obligations under the 1999
Agreement.
9.3 NOTICE; COOPERATION. In the event of any such indemnifiable
claim, the indemnified Party shall promptly notify the
indemnifying Party in writing of the claim and the
indemnifying Party shall manage and control, at its sole
expense, the defense of the claim and its settlement. The
indemnified Party shall cooperate with the indemnifying Party
and may, at its option and expense, be represented in any such
action or proceeding. The indemnifying Party shall not be
liable for any settlements, litigation costs, or expenses
incurred by the indemnified Party without the indemnifying
Party's written consent, such consent to be promptly given and
not unreasonably withheld.
9.4 LIABILITY LIMITATION. Neither GI nor MetaMorphix shall be
liable for special, incidental or consequential damages or for
loss of profit or lost revenue, even another Party had been
advised of the possibility of such damages.
9.5 INSURANCE. Prior to initial human testing or first commercial
sale of any GDF-8 Product in any particular country by a
Party, such Party shall secure and maintain at its own expense
during the term of this Agreement either self insurance or an
insurance policy or policies with an insurer or insurers
acceptable to the other Parties, in either case, protecting
the Parties against any and all risks typically insured
against by businesses comparable to the Party, including
without limitation general and products liability, arising or
occurring upon or in connection with each Party's business.
Such policy or policies shall include general and products
liability coverage in an amount typically secured by
businesses comparable to the Party. Each Party shall furnish
the other Party with certificates evidencing all such
insurance. Each Party shall name the other Party and JHU as
additional insured in such policy or policies.
CONFIDENTIAL -24-
10. TERM AND TERMINATION.
10.1 TERM. This Agreement shall remain in effect until terminated
in accordance with the provisions of this Section 10 or until
the last to expire of any of the exclusive licenses granted
pursuant to this Agreement.
10.2 TERMINATION FOR BREACH. In the event that a Party shall be in
default of any of its material obligations to another Party
hereunder, and shall fail to remedy any such default within
sixty (60) days after notice thereof by the non-breaching
Party to whom such obligations are owed, such non-breaching
Party shall, by written notice to the other Party, be entitled
to terminate the rights it granted to the breaching Party
under this Agreement and its obligations to the breaching
Party under this Agreement. Any such notice shall specifically
describe the alleged default and expressly state that the
non-breaching Party intends to terminate the rights it has
granted to the breaching Party under this Agreement in the
event that the breaching Party shall fail to remedy the
default. Upon any termination of this Agreement pursuant to
this Section 10.2, the Parties shall not be relieved of any
obligations incurred prior to such termination.
Notwithstanding the foregoing, a termination of this Agreement
under this Section 10.2 shall have no effect on the 1999
Agreement and any termination of the 1999 Agreement under
Section 14.2 thereof shall have no effect on this Agreement.
10.3 SURVIVAL OF OBLIGATIONS; RETURN OF CONFIDENTIAL INFORMATION.
Notwithstanding any termination of this Agreement, the
obligations of the Parties under Sections 7, 9, 10.3, 11.1,
11.6 and 11.15 as well as under any other provisions which by
their nature are intended to survive any such termination,
shall survive and continue to be enforceable. Upon any
termination of this Agreement pursuant to Section 10.2 hereof,
the breaching Party shall promptly return to the non-breaching
Party all written Confidential Information, and all copies
thereof, of the non-breaching Party, which is not covered by a
license surviving such termination.
11. MISCELLANEOUS.
11.1 PUBLICITY. No Party, nor any of its Affiliates, shall
originate any publicity, news release or other public
announcement, written or oral, relating to this Agreement
without the prior written approval of the other Parties, which
approval shall not be unreasonably withheld, except as
otherwise required by law. It is expressly understood that
nothing in this Section 11.1 shall prevent a Party from making
a disclosure in connection with any required filings with the
Securities and Exchange Commission or in connection with the
offering of securities or any financing. In addition, neither
GI nor MetaMorphix shall use the name of the other Party in
any advertising,
CONFIDENTIAL -25-
promotional, sales literature or fundraising documents without
the prior written consent of such other Party.
11.2 EXPORT CONTROL. The Parties acknowledge that the export of
technical data, materials, or products is subject to the
exporting Party receiving the necessary export licenses and
that the Parties cannot be responsible for any delays
attributable to export controls that are beyond the reasonable
control of either Party. The Parties agree that regardless of
any disclosure made by the Party receiving an export of an
ultimate destination of any technical data, materials, or
products, the receiving Party will not reexport either
directly or indirectly, any technical data, material, or
products without first obtaining the applicable validated or
general license from the United States Department of Commerce,
United States Food and Drug Administration, and/or any other
agency or department of the United States Government, as
required. The receiving Party shall provide the exporting
Party with any information, materials, certifications, or
other documents which may be reasonably required in connection
with such exports under the Export Administration Act of 1979,
as amended, its rules and regulations, the Federal Food, Drug
and Cosmetic Act, and other applicable export laws.
11.3 CONDUCT OF STUDIES. All studies, research and testing done by
or on behalf of each Party under this Agreement shall be
performed in strict compliance with any applicable federal,
state, or local laws, rules, and regulations governing the
conduct of studies, research, and testing at the site where
such studies, research, and testing are being conducted.
11.4 NO IMPLIED LICENSES. Only the licenses granted pursuant to the
express terms of this Agreement shall be of any legal force
and effect. No license rights shall be created by implication
or estoppel.
11.5 NO AGENCY. Nothing herein shall be deemed to constitute any
Party as the agent or representative of the other Parties, or
the Parties as joint venturers or partners for any purpose.
Each Party shall be an independent contractor, not an employee
or partner of the other Parties, and the manner in which each
Party renders its services under this Agreement shall be
within its sole discretion. No Party shall be responsible for
the acts or omissions of the other Parties, and no Party will
have authority to speak for, represent or obligate the other
Parties in any way without prior written authority from the
other Party or Parties.
11.6 NOTICE. All notices required under this Agreement to be given
by one Party to another shall be in writing and shall be given
by addressing the same to the other at the address or
facsimile number set forth below, or at such other addresses
or facsimile numbers as the Parties may specify in writing.
All notices shall become effective when deposited in the
United States Mail with proper postage for first class
registered or certified mail prepaid, return
CONFIDENTIAL -26-
receipt requested, or when delivered personally, or, if
promptly confirmed by mail as provided above, when dispatched
by facsimile.
If to GI:
Genetics Institute, Inc. 00
XxxxxxxxxXxxx Xxxxx Xxxxxxxxx,
Xxxxxxxxxxxxx 00000
Telecopier: (000) 000-0000
Attn: Legal Department
If to MetaMorphix:
MetaMorphix, Inc.
0000X Xxxxxxxx Xxxx
Xxxxxx, Xxxxxxxx 00000
Telecopier: (000) 000-0000
Attn: President
with copies to:
Wyeth
0 Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000.
Telecopier: (000) 000-0000
Attn: General Counsel
and
Xxxxxxx Xxxx Guinot & Sandler
00 Xxxxx Xxxxxxx Xxxxxx - Xxxxx 0000
Xxxxxxxxx, XX 00000-0000
Telecopier: (000) 000-0000
Attn: Xxxxxxx X. Xxxxxxx, Esq.
11.7 ASSIGNMENT. This Agreement, and the rights and obligations
hereunder, may not be assigned or transferred, in whole or in
part, by any Party without the prior written consent of the
other Parties, except that (a) upon notice to the other Party,
GI may assign this Agreement to an Affiliate controlled by GI,
and MetaMorphix may assign this Agreement to an Affiliate
which is majority controlled by MetaMorphix, provided that
each such Party remains primarily liable and/or responsible
for the performance of such obligations and such controlled
Affiliate, and provided further that such controlled Affiliate
agrees to be bound to the terms and conditions of this
Agreement and (b) upon notice to the other Party, GI may
assign this Agreement in connection with the merger,
consolidation or sale of all or substantially all of GI's
assets and MetaMorphix may assign this Agreement in connection
with the merger, consolidation or sale of all or substantially
all of MetaMorphix' assets.
CONFIDENTIAL -27-
11.8 ENTIRE AGREEMENT. This Agreement and the exhibits and
schedules attached hereto, together, constitute the entire
agreement of the Parties with regard to its subject matter,
and supersedes all previous written or oral representations,
agreements and understandings between the Parties.
Notwithstanding the foregoing, the Parties hereby acknowledge
and agree that the 1999 Agreement shall remain in full force
and effect in accordance with the terms and conditions set
forth therein except to the extent expressly amended hereby
and that this Agreement is in addition to and should be
interpreted in light of the rights and obligations of each of
the Parties under the 1999 Agreement.
11.9 NO MODIFICATION. This Agreement may be changed only by a
writing signed by the Parties.
11.10 HEADINGS. The headings contained in this Agreement are for
convenience of reference only and shall not be considered in
construing this Agreement.
11.11 WAIVER. The waiver by any Party of a breach or a default of
any provision of this Agreement by another Party shall not be
construed as a waiver of any succeeding breach of the same or
any other provision, nor shall any delay or omission on the
part of any Party to exercise or avail itself of any right,
power or privilege that it has or may have hereunder operate
as a waiver of any right, power, or privilege by such Party.
11.12 SEVERABILITY. In the event that any one or more of the
provisions contained in this Agreement shall, for any reason,
be held to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall
not affect any other provisions of this Agreement, and all
other provisions shall remain in full force and effect. If any
of the provisions of this Agreement is held to be excessively
broad or invalid, illegal or unenforceable in any
jurisdiction, it shall be reformed and construed by limiting
and reducing it so as to be enforceable to the maximum extent
permitted by law in conformance with its original intent.
11.13 SUCCESSORS AND ASSIGNS. This Agreement shall be binding upon
and inure to the benefit of the Parties hereto and their
successors and permitted assigns.
11.14 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but
all of which together shall constitute one and the same
instrument.
CONFIDENTIAL -28-
11.15 APPLICABLE LAW. This Agreement shall in all events and for all
purposes be governed by, and construed in accordance with, the
law of the State of Maryland without regard to any choice of
law principle that would dictate the application of the law of
another jurisdiction.
IN WITNESS WHEREOF, duly-authorized representatives of the
parties have signed this Agreement as a document under seal as of the Effective
Date.
GENETICS INSTITUTE, LLC METAMORPHIX,INC.
By: /s/ Xxxxxx X. Xxxxx By: /s/ Xxxxx X. Xxxxxxxxxxx
Xxxxxx X. Xxxxx Xxxxx X. Xxxxxxxxxxx, Ph.D.
Vice President President and Chief Executive Officer
CONFIDENTIAL -29-
EXHIBIT 1.2.10
GI EXCLUDED PRODUCTS
--------------------
None as of Effective Date.
CONFIDENTIAL
EXHIBIT 1.2.12
GI GDF-8 PATENT RIGHTS
----------------------
--------------------------------------------------------------------------------
WYETH PATENT/APP # TITLE COUNTRY STATUS FILED
DOCKET #
--------------------------------------------------------------------------------
*** *** *** US Filed 02/08/02
--------------------------------------------------------------------------------
*** *** *** PCT Filed 02/08/02
--------------------------------------------------------------------------------
*** *** *** Argentina Filed 02/08/02
--------------------------------------------------------------------------------
*** *** *** Chile Filed 02/07/02
--------------------------------------------------------------------------------
*** *** *** Taiwan Filed 02/07/02
--------------------------------------------------------------------------------
*** *** *** Venezuela Filed 02/08/02
I
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
*** *** US Filed 09/26/02
--------------------------------------------------------------------------------
*** *** PCT Filed 09/26/02
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
*** *** *** US Filed 02/21/02
--------------------------------------------------------------------------------
*** *** *** US Filed 02/21/02
--------------------------------------------------------------------------------
CONFIDENTIAL
EXHIBIT 1.2.15
JOINT GDF-8 PATENT RIGHTS
None as of Effective Date.
CONFIDENTIAL
EXHIBIT 1.2.16
METAMORPHIX EXCLUDED PRODUCTS
None as of Effective Date
CONFIDENTIAL
EXHIBIT 1.2.18
METAMORPHIX GDF-8 PATENT RIGHTS
-------------------------------
-------------------------------------------------------------------------------
PATENT / APP # TITLE COUNTRY STATUS
-------------------------------------------------------------------------------
*** *** US Issued
-------------------------------------------------------------------------------
*** *** Argentina Pending
-------------------------------------------------------------------------------
*** *** Brazil Pending
-------------------------------------------------------------------------------
*** *** Canada Pending
-------------------------------------------------------------------------------
*** *** Europe Pending
-------------------------------------------------------------------------------
*** *** Japan Pending
-------------------------------------------------------------------------------
*** *** Mexico Pending
-------------------------------------------------------------------------------
*** *** New Zealand Pending
-------------------------------------------------------------------------------
*** *** South Africa Issued
-------------------------------------------------------------------------------
*** *** US Pending
-------------------------------------------------------------------------------
*** *** World Published
-------------------------------------------------------------------------------
*** *** World Published
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
*** *** US Pending
-------------------------------------------------------------------------------
*** *** Canada Pending
-------------------------------------------------------------------------------
*** *** Europe Pending
-------------------------------------------------------------------------------
*** *** Japan Pending
-------------------------------------------------------------------------------
*** *** US Pending
-------------------------------------------------------------------------------
*** *** World Pending
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
*** *** US Pending
-------------------------------------------------------------------------------
*** *** Australia National
-------------------------------------------------------------------------------
*** *** Brazil Pending
-------------------------------------------------------------------------------
*** *** Canada Pending
-------------------------------------------------------------------------------
*** *** China Published
-------------------------------------------------------------------------------
*** *** Europe Published
-------------------------------------------------------------------------------
*** *** Japan National
Phase
-------------------------------------------------------------------------------
CONFIDENTIAL
EXHIBIT 1.2.18
METAMORPHIX GDF-8 PATENT RIGHTS
-------------------------------
-------------------------------------------------------------------------------
PATENT / APP # TITLE COUNTRY STATUS
-------------------------------------------------------------------------------
*** *** Mexico Pending
-------------------------------------------------------------------------------
*** *** New Zealand National
Phase
-------------------------------------------------------------------------------
*** *** World Pending
-------------------------------------------------------------------------------
-------------------------------------------------------------------------------
*** *** US Issued
-------------------------------------------------------------------------------
*** *** Australia Pending
-------------------------------------------------------------------------------
*** *** Canada Pending
-------------------------------------------------------------------------------
*** *** Europe Pending
--------------------------------------------------------------------------------
*** *** US Pending
--------------------------------------------------------------------------------
*** *** World National
Phase
--------------------------------------------------------------------------------
CONFIDENTIAL
