EXHIBIT 10.4
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
AMENDED AND RESTATED COLLABORATION AGREEMENT
By and Among
GENZYME CORPORATION,
GENZYME TRANSGENICS CORPORATION
and
ATIII LLC
Dated as of July 31, 2001
AMENDED AND RESTATED
COLLABORATION AGREEMENT
THIS AMENDED AND RESTATED COLLABORATION AGREEMENT dated as of July 31,
2001 (as amended and otherwise modified in accordance with its terms, this
"AGREEMENT") is made among Genzyme Corporation, a Massachusetts corporation
having its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("GENZYME"), Genzyme Transgenics Corporation, a
Massachusetts corporation having its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("GTC"), and ATIII LLC, a Delaware
limited liability company having its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("ATIII LLC"). Genzyme, GTC and ATIII
LLC are sometimes referred to herein individually as a "PARTY" and collectively
as the "PARTIES."
RECITALS
WHEREAS, the Parties entered into the Collaboration Agreement dated as
of January 1, 1998 (the "ORIGINAL COLLABORATION AGREEMENT") to develop and
commercialize the "Collaboration Products" (as defined therein) throughout the
"Territory" (as defined therein) pursuant to the Original Collaboration
Agreement; and
WHEREAS, GTC has purchased from Genzyme Genzyme's percentage interest
in ATIII LLC pursuant to the Purchase Agreement dated of even date herewith and
in accordance with the terms and conditions of the Amended and Restated
Operating Agreement of ATIII LLC dated as of January 1, 1998 between GTC and
Genzyme (the "ORIGINAL OPERATING AGREEMENT"). In connection therewith, GTC and
Genzyme have taken such member actions and other actions as are necessary and
appropriate for Genzyme to withdraw from ATIII LLC; and
WHEREAS, GTC desires to license from Genzyme, and Genzyme desires to
license to GTC, the "Genzyme Patent Rights" and "Genzyme Technology" and
Genzyme's interest, if any, in the "Genzyme/GTC Patent Rights" and "Genzyme/GTC
Technology," in each case, as such term is defined in the Original Collaboration
Agreement.
NOW THEREFORE, in consideration of the premises and of the covenants
herein contained, the Parties mutually agree to amend and restate the Original
Collaboration Agreement as follows:
ARTICLE 1. DEFINITIONS
Section 1.1. DEFINED TERMS.
(a) CERTAIN DEFINED TERMS. For purposes of this Agreement the
terms defined in this Section 1.1 shall have the meanings specified below (such
meanings to be equally applicable to both the singular and plural forms of the
terms defined).
"AFFILIATE" shall mean any corporation or other entity that controls,
is controlled by, or is under common control with a Party. A corporation or
other entity shall be regarded as in control of another corporation or entity if
(i) it owns or controls, directly or indirectly, more than 50% of the voting
stock or other equity interest of such other corporation or entity, or (ii) it
possesses, directly or indirectly, the power to direct or cause the direction of
the management and policies of such other corporation or entity or the
1
power to elect or appoint more than 50% of the members of the governing body of
the corporation or other entity.
"BUSINESS DAY" shall mean any day on which the banks are open for
commercial banking business in The Commonwealth of Massachusetts.
"COLLABORATION PRODUCT" shall mean any product comprising ATIII
together with any process developed for use in the Field by a Party utilizing,
based upon or arising out of the Genzyme Patent Rights, the GTC Intellectual
Property Rights, the Genzyme/GTC Patent Rights, the Genzyme Technology, the GTC
Technology, the Genzyme/GTC Technology or the Manufacturing Know-How owned or
controlled by any Party, including, without limitation, any and all
improvements, combination products, delivery systems and dosage forms related
thereto.
"DEVELOPMENT PROGRAM" shall mean the preclinical and clinical
development of Collaboration Products, including the preparation and filing of
all applications for Regulatory Approvals for each Collaboration Product.
"FIELD" shall mean any and all indications for ATIII.
"GENZYME PATENT RIGHTS" shall mean all present Patent Rights owned or
controlled by, or licensed (with the right to sublicense where possible) to
Genzyme, to the extent that such Patent Rights cover a compound, composition,
biological or other material, product-by process, method, apparatus,
manufacturing or other process, relating to or useful for the research,
development, manufacture or commercialization of Collaboration Products for use
in the Field, including the Genzyme Patent Rights listed in Schedule I hereto.
"GENZYME TECHNOLOGY" shall mean Technology (as defined below) owned and
controlled by, or licensed (with the right to sublicense) to, Genzyme relating
to or useful for the research, development, manufacture or commercialization of
Collaboration Products for use in the Field.
"GENZYME/GTC PATENT RIGHTS" shall mean the Patent Rights that claim
Joint Inventions that have been or are jointly discovered, made or conceived
during and in connection with the "Program" as defined in the Original
Collaboration Agreement and the Program to the extent that such Patent Rights
cover a compound, composition, biological or other material, product-by-process,
method, apparatus, manufacturing or other process, or transgenic technology
relating to or useful for the research, development, manufacture or
commercialization of Collaboration Products for use in the Field.
"GENZYME/GTC TECHNOLOGY" shall mean all Technology discovered, made or
conceived during and in connection with the "Program" as defined in the Original
Collaboration Agreement and hereunder, and future Technology owned or controlled
by, or licensed (with the right to sublicense where possible) to either Genzyme
or GTC relating to or useful for the research, development, manufacture or
commercialization of Collaboration Products for use in the Field.
"GTC INTELLECTUAL PROPERTY RIGHTS" shall mean, collectively, the "GTC
Patent Rights," the "GTC Licensed ATIII Patent Rights" and the "GTC Technology"
as each term is defined in the Original Collaboration Agreement.
"GTC LICENSED ATIII PATENT RIGHTS" shall mean all present and future
Patent Rights in the Territory sublicensed (whether exclusively or
nonexclusively) by GTC from Behring pursuant to the Agreement dated September
29, 1990 by and between Behringwerke Aktiengesellschaft, a subsidiary of
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Hoechst ▇▇▇▇▇▇ ▇▇▇▇▇▇▇, SMIG and GTC (as the successor to Genzyme's interest
therein) (the "ORIGINAL ATIII AGREEMENT").
"GTC PATENT RIGHTS" shall mean, except as to GTC Licensed ATIII Patent
Rights, all present Patent Rights owned or controlled by, or licensed (with the
right to sublicense where possible) to, GTC, to the extent that such Patent
Rights cover a compound, composition, biological or other material,
product-by-process, method, apparatus, manufacturing or other process, or
transgenic production technology relating to or useful for the research,
development, manufacture or commercialization of Collaboration Products for use
in the Field.
"GTC TECHNOLOGY" shall mean all present Technology owned or controlled
by, or licensed (with the right to sublicense where possible) to, GTC relating
to or useful for the research, development, manufacture or commercialization of
Collaboration Products for use in the Field.
"LIABILITY" shall mean any liability, losses, damages, costs, expenses,
fees and other amounts payable in connection with any of the foregoing.
"MANUFACTURING KNOW-HOW" shall mean all information, techniques,
inventions, discoveries, improvements, practices, methods, knowledge, skill,
experience and other technology, whether or not patentable or copyrightable, and
any patent applications, patents or copyrights based thereon, relating to or
necessary or useful for the production, purification, packaging, testing,
storage and transportation of Collaboration Products, including without
limitation specifications, acceptance criteria, manufacturing batch records,
standard operating procedures, engineering plans, installation, operation and
process qualification protocols for equipment, validation records, master files
submitted to the FDA, process validation reports, environmental monitoring
processes, test data, including biochemical, pharmacological, toxicological and
clinical test data, cost data and employee training materials.
"PATENT RIGHTS" shall mean patents, patent applications, certificates
of invention, or applications for certificates of invention, together with any
extensions, registrations, confirmations, re-issues, divisions, continuations or
continuations-in-part, re-examination or renewals thereof.
"SMIG TERRITORY" shall mean Japan, China, Taiwan, Thailand, India, Sri
Lanka, Indonesia, Philippines, Vietnam, Singapore, Malaysia, Hong Kong, Myanmar
(Burma), ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇, ▇▇▇▇▇▇▇▇ and their respective
succession states.
"TECHNOLOGY" shall mean inventions, trade secrets, copyrights,
know-how, data and other intellectual property of any kind (including without
limitation any proprietary biological or other materials, compounds or reagents,
and transgenic production technology but not including Patent Rights).
"TERRITORY" shall mean the world excluding the SMIG Territory.
"THIRD PARTY" shall mean any entity other than ATIII LLC, GTC or
Genzyme and their respective Affiliates.
"TRANSGENIC ANIMAL" shall mean a non-human animal, or an egg, sperm or
embryo of such animal, that bears in its germline a foreign gene derived from
another animal species.
"TRANSGENIC ATIII", which may be abbreviated as "ATIII", shall mean
recombinant human ATIII produced by expression of a recombinant ATIII gene or
ATIII cDNA or combination thereof in the milk of a Transgenic Animal bearing
such a gene, cDNA or combination in its genome.
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(b) ADDITIONAL DEFINED TERMS. The following capitalized terms
have the meaning ascribed thereto in the Section listed with respect to such
capitalized term.
TERM SECTION
Agreement Preamble
ATIII LLC Preamble
Dispute 8.6
Genzyme Preamble
Genzyme Invention 4.1
GTC Preamble
GTC Inventions 4.1
Information 5.1
Inventions 4.1
Joint Inventions 4.1
Licenses 3.1
Original Collaboration Agreement Recitals
Original Operating Agreement Recitals
Party Preamble
ARTICLE 2. SCOPE AND STRUCTURE OF THE COLLABORATION
Section 2.1. GENERAL. The Parties agree that GTC and ATIII LLC, or
such other designee of GTC as GTC may determine, will continue to use its
commercially reasonable efforts to pursue the Development Program. GTC hereby
assumes the obligations with respect thereto of Genzyme under the Original
Collaboration Agreement on and from the date of this Agreement. Genzyme shall
grant the Licenses (as defined in Section 3.1 below) as provided in Article 3
hereof on the terms provided therein. As used in this Agreement, the term
"commercially reasonable efforts" will mean that level of effort which,
consistent with the exercise of prudent scientific and business judgment, is
applied by GTC to its other therapeutic products at a similar stage of
development and with similar commercial potential.
Section 2.2. EXCLUSIVE RELATIONSHIP. During the term of this
Agreement, neither Genzyme nor its Affiliates (excluding therefrom GTC
Affiliates controlled by it for the purposes of this Section 2.2) shall
independently or with any Third Party conduct research or development activities
regarding, or engage in the manufacture, marketing, sale or distribution of,
products comprising ATIII in the Field and in the Territory other than as
expressly permitted under this Agreement. Notwithstanding the foregoing, nothing
herein is intended to restrict Genzyme or its Affiliates from conducting
research or development activities regarding, or engaging in the manufacture,
marketing, sale or distribution of, (i) aaATIII or (ii) products that have
substantially different biomedical pathways and are targeted to the same
indications included hereunder.
Section 2.3. REVOCATION OF CERTAIN LICENSES. ATIII LLC hereby revokes
each grant of rights and sublicenses by ATIII LLC to Genzyme pursuant to Section
3.2 of the Original Collaboration Agreement. ATIII LLC also hereby revokes any
grant of the right and license to use any and all trademarks owned or licensed
(with the right to sublicense) to ATIII LLC granted by ATIII LLC to Genzyme
pursuant to Section 3.2 of the Original Collaboration Agreement.
Section 2.4. EXCLUSIVE ENGAGEMENT. Genzyme and ATIII LLC hereby
terminate ATIII LLC's engagement of Genzyme on an exclusive basis to market and
sell Collaboration Products within the Territory for use within the Field as of
the date of this Agreement.
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ARTICLE 3. GRANTS AND RESERVATIONS OF RIGHTS
Section 3.1. LICENSES OF RIGHTS TO GTC. Genzyme hereby grants to GTC
the following licenses (the "LICENSES") on the terms and conditions set forth in
this Article 3.
(a) EXCLUSIVE GRANT. Genzyme hereby grants to GTC an
exclusive, irrevocable (during the term of this Agreement), royalty-free right
and sublicense, with the right to grant further sublicenses, under the
Genzyme/GTC Patent Rights and the Genzyme/GTC Technology and any associated
Technology and Manufacturing Know-How owned or controlled by Genzyme to develop,
make, have made, use, offer for sale, sell, have sold, import and export
Collaboration Products for use in the Field and in the Territory.
(b) NON-EXCLUSIVE GRANT. Genzyme hereby grants to GTC a
non-exclusive, irrevocable (during the term of this Agreement), royalty-free
right and license, with the right to grant sublicenses, under the Genzyme Patent
Rights, Genzyme Technology and the Manufacturing Know-How owned or controlled by
Genzyme, to develop, make, have made, use, offer for sale, sell, have sold,
import and export Collaboration Products for use in the Field and in the
Territory.
Section 3.2. GTC UNDERTAKINGS; SUBLICENSES. In consideration of the
Licenses granted under this Section 3.1 above, GTC hereby agrees to pay all
royalties, sublicense fees and other costs or expenses payable to Third Parties
associated with the acquisition or use of such Licenses by GTC including without
limitation those listed in SCHEDULE 3.2 hereto.
Section 3.3. SUBLICENSE OF RIGHTS TO ATIII LLC. GTC hereby grants to
ATIII LLC a non-exclusive, royalty-free right and license, with the right to
grant sublicenses, under GTC Intellectual Property Rights, the Manufacturing
Know-How owned or controlled by GTC, the Genzyme Patent Rights, Genzyme
Technology and the Manufacturing Know-How owned or controlled by Genzyme, to
develop, make, have made, use, offer for sale, sell, have sold, import and
export Collaboration Products for use in the Field and in the Territory.
Section 3.4. RESERVATION OF RIGHTS. Notwithstanding the license grants
set forth in Sections 3.1 and 3.3 above, each of Genzyme and GTC reserves, at
all times, its rights under the Patent Rights, Technology and Manufacturing
Know-How that such Party owns and/or otherwise controls (each prior to, and
without giving effect to, any licensing under this Agreement or the Original
Collaboration Agreement) (a) to make, have made and use Collaboration Products
for research and development purposes only, (b) to develop, make, have made,
use, offer for sale, sell, have sold, import and export (i) products outside the
Field and (ii) products other than products comprising ATIII and (c) to grant
licenses to Third Parties for the foregoing purposes.
ARTICLE 4. INTELLECTUAL PROPERTY RIGHTS
Section 4.1. FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS. Each
of GTC and Genzyme shall be responsible for the filing, prosecution and
maintenance of all patent applications and patents, including, without
limitation, for the payment of all costs and expenses arising therefrom, which
make up its Patent Rights. GTC shall be responsible for the filing, prosecution
and maintenance of all patent applications and patents which make up Genzyme/GTC
Patent Rights; PROVIDED, HOWEVER, that the Party designated by the "Steering
Committee" (as defined in the Original Collaboration Agreement) pursuant to
Section 8.2.1 of the Original Collaboration Agreement to file, prosecute and/or
maintain such
5
patent application or patent shall continue to be so responsible unless and
until GTC and Genzyme shall agree otherwise; PROVIDED FURTHER, HOWEVER, that
each of GTC and Genzyme shall share equally in the cost and expense of any such
filing application or maintenance. For so long as any of the licenses granted
under Article 3 hereof remain in effect and upon the request of GTC, Genzyme
agrees to file and prosecute patent applications and maintain the patents
covering the Genzyme Patent Rights in all countries in the Territory reasonably
requested by GTC.
Section 4.2. COOPERATION. Genzyme shall consult with and keep GTC fully
informed of important issues relating to the preparation and filing (if time
permits), prosecution and maintenance of the Genzyme Patent Rights and, if
applicable, the Genzyme/GTC Patent Rights allocated to Genzyme's under Section
4.1 above. Genzyme shall make available to GTC (or to such Party's authorized
attorneys, agents or representatives) its employees, agents or consultants to
the extent necessary or appropriate to enable GTC to file, prosecute and
maintain patent applications and resulting patents with respect to GTC Patent
Rights and for periods of time sufficient for GTC Party to obtain the assistance
it needs from such personnel. Where appropriate, Genzyme shall sign or cause to
have signed all documents relating to said patent applications or patents at no
charge to GTC.
Section 4.3. NOTIFICATION OF PATENT TERM RESTORATION. Genzyme shall
notify GTC of (a) the issuance of each United States patent included within the
Genzyme Patent Rights (and, if applicable, the Genzyme/GTC Patent Rights),
giving the date of issue and the patent number for each such patent, and (b)
each notice pertaining to any patent included within the Genzyme Patent Rights
that it receives as patent owner pursuant to the Drug Price Competition and
Patent Term Restoration Act of 1984. Such notice shall be given promptly, but in
any event within ten (10) Business Days after receipt of such notice pursuant to
such Act. Genzyme shall notify GTC of each filing for patent term restoration
under such Act, any allegations of failure to show due diligence and all awards
of patent term restoration (extensions) with respect to the Genzyme Patent
Rights. GTC shall notify Genzyme of the issuance of each United States Patent
included in the Genzyme/GTC Patent Rights, giving the date of issue and the
patent number of each such patent.
Section 4.4. NO OTHER TECHNOLOGY RIGHTS. Except as otherwise expressly
provided in this Agreement, under no circumstances shall a Party hereto, as a
result of this Agreement, obtain any ownership interest in or other right to the
Patent Rights, Technology or Manufacturing Know-How of any other Party,
including items owned, controlled or developed by any other Party, or
transferred by another Party to any such Party at any time pursuant to this
Agreement. It is understood and agreed that this Agreement does not grant GTC,
Genzyme or ATIII LLC any license or other right in or to the Patent Rights of
such other Party for uses other than as specified in Article 3 hereof and this
Article 4.
Section 4.5. ENFORCEMENT OF PATENT RIGHTS; DEFENSE OF INFRINGEMENT
ACTIONS.
(a) GTC, on its own behalf and on behalf of ATIII LLC, and
Genzyme shall each promptly notify the other in writing of any alleged or
threatened infringement of any Patent Rights that it owns or for which it is
responsible pursuant to Section 4.1 above or if either Party, or any of their
respective Affiliates, shall be individually named as a defendant in a legal
proceeding by a Third Party for infringement because of the manufacture, use or
sale of a Collaboration Product or because of attempts to invalidate such Patent
Rights.
(b) Each of GTC and Genzyme shall have the first right to
respond to or defend against such challenge or infringement of the Patent Rights
that it owns or for which it is responsible pursuant to Section 4.1 above. In
the case of any Genzyme/GTC Patent Rights, and in the event such Party elects to
so respond or defend, the other Party will cooperate with the responding Party's
legal counsel,
6
join in such suits as may be brought by the responding Party to enforce such
Patent Rights, and be available at the responding Party's reasonable request to
be an expert witness or otherwise to assist in such proceedings.
(c) The costs incurred on and after the date hereof (i) in
responding to or defending against a challenge to or infringement of a Party's
Patent Rights specific to the Field or a charge that the manufacture, use or
sale of Collaboration Products infringes upon the Patent Rights of Third
Parties, (ii) in settling any such actions (which settlement may not be done
without the prior written consent of GTC) and (iii) as damages paid as a result
of such actions shall be borne, in the case of any GTC Patent Rights, by GTC
and, in the case of any Genzyme Patent Rights or Genzyme/GTC Patent Rights, by
GTC at its election, and otherwise by Genzyme or the Party responsible therefor
pursuant to Section 4.1 above; PROVIDED that, any such election of GTC shall be
conditioned upon, unless GTC shall expressly waive any such performance, that
GTC shall be reasonably satisfied that Genzyme (x) shall have complied in all
material respects with the terms of the Original Collaboration Agreement and
this Agreement in connection with such Genzyme/GTC Patent Rights, (y) shall not
have acted grossly negligent or committed any misconduct with respect to such
challenge or infringement, and (z) shall have assigned irrevocably and otherwise
conveyed Genzyme's right, title and interest in and to such Patent Rights to
GTC.
(d) SECOND RIGHT TO RESPOND. If Genzyme does not exercise its
right to respond to or defend against any challenge or infringement of its
Patent Rights as provided in clause (b) above within sixty (60) days of becoming
aware of or being notified of such challenges or infringements, then GTC shall
have the option to do so at its sole cost; PROVIDED that in such case all
amounts so recovered from such Third Party shall be retained by GTC and GTC may
decline or withdraw at any time from such response or defense whereupon GTC
shall have no further obligations to Genzyme with respect to the response or
defense thereof.
ARTICLE 5. CONFIDENTIALITY
Section 5.1. NONDISCLOSURE OBLIGATIONS. Except as otherwise provided in
this Article 5, during the term of this Agreement and for a period of five (5)
years thereafter, the Parties shall maintain in confidence and use only for
purposes specifically authorized under this Agreement (a) confidential
information and data resulting from or related to the development of
Collaboration Products and (b) all information and data not described in clause
(a) but supplied by another Party under this Agreement and marked or identified
as "Confidential" (the information and data described in the foregoing clauses
(a) and (b) being referred to herein as the "INFORMATION"). To the extent it is
reasonably necessary or appropriate to fulfill its obligations or exercise its
rights under this Agreement, a Party may disclose Information it is otherwise
obligated under this Section not to disclose to its Affiliates, sublicensees,
consultants, outside contractors and clinical investigators, on a need-to-know
basis and on the condition that such entities or persons agree to keep the
Information confidential for the same time periods and to the same extent as
such Party is required to keep the Information confidential. A Party or its
sublicensees may disclose such Information to government or other regulatory
authorities to the extent that such disclosure is reasonably necessary to obtain
patents or authorizations to conduct clinical trials with and to market
commercially Collaboration Products. The obligation not to disclose Information
shall not apply to any part of such Information that: (i) is or becomes
patented, published or otherwise becomes publicly known other than by acts of
the Parties obligated not to disclose such Information or their respective
Affiliates or sublicensees in contravention of this Agreement; (ii) can be shown
by written documents to have been disclosed to the receiving Party or its
Affiliates or sublicensees by a Third Party, provided that such Information was
not obtained by such Third Party directly or indirectly from the other Party
under this Agreement or the Original Collaboration Agreement; (iii) prior to
disclosure under this Agreement, was already in the possession of the receiving
Party or its Affiliates or sublicensees, PROVIDED that such Information was not
7
obtained directly or indirectly from another Party under this Agreement or the
Original Collaboration Agreement; (iv) can be shown by written documents to have
been independently developed by the receiving Party or its Affiliates without
breach of any of the provisions of this Agreement or the Original Collaboration
Agreement; or (v) is disclosed by the receiving Party pursuant to a subpoena
lawfully issued by a court or governmental agency, provided that the receiving
Party notifies the applicable Party immediately upon receipt of any such
subpoena.
Section 5.2. TERMS OF THIS AGREEMENT. The Parties further agree that
the terms of this Agreement shall be, and shall be deemed to be confidential and
shall not be disclosed except as expressly permitted in this Section 5.2. Except
as otherwise required by applicable law or regulation, each Party agrees not to
disclose any terms or conditions of this Agreement to any Third Party without
the prior consent of, in the case of GTC and ATIII LLC, Genzyme, and, in the
case of Genzyme, GTC; PROVIDED that each Party shall be entitled to disclose the
terms of this Agreement without such consent to potential investors or other
financing sources on the condition that such entities or persons agree to keep
such terms confidential for the same time periods and to the same extent as such
Party is required to keep such terms confidential; PROVIDED FURTHER that
promptly after the execution of this Agreement, the Parties shall discuss and
mutually agree upon the provisions of an initial a press release announcing the
existence of this Agreement, the Purchase Agreement and the Services Agreement
of even date herewith and certain terms thereof to the extent either Party
reasonably determines that such disclosure is required under applicable laws or
regulations or is advisable. Notwithstanding the foregoing, Genzyme and GTC
agree that the information contained in a press release mutually agreed upon by
the Parties in advance may be used to describe the nature of this transaction,
Genzyme and GTC may disclose the information contained in any such agreed upon
and issued press release, as modified by mutual agreement from time to time,
without the other Party's consent.
ARTICLE 6. REPRESENTATIONS AND WARRANTIES
Section 6.1. MUTUAL REPRESENTATIONS. Each Party warrants and represents
to the other that (a) it has the legal right and power to enter into this
Agreement, to extend the right and licenses granted to the other in this
Agreement, and to perform fully its obligations hereunder, (b) this Agreement is
a valid and binding agreement of such Party enforceable in accordance with its
terms, (c) such Party has obtained all necessary approvals to the transactions
contemplated hereby and (d) such Party has not made nor will it make any
commitments to the other in conflict with or in derogation of such rights or
this Agreement.
Section 6.2. REPRESENTATIONS OF GENZYME. Genzyme hereby represents and
warrants that as of the date hereof (a) it possesses an exclusive right, title
and interest in the Genzyme Patent Rights and the Genzyme Technology, (b) the
Genzyme Patent Rights and the Genzyme Technology are free and clear of any lien
or other encumbrance and (c) it has the right to (i) enter into and perform the
obligations set forth in this Agreement and (ii) grant the rights and licenses
set forth in Article 3 hereof.
ARTICLE 7. TERM AND TERMINATION
Section 7.1. TERM. The term of this Agreement shall be perpetual
unless terminated pursuant to this Section 7.1(a), as follows:
(a) GTC may terminate this Agreement upon at least twenty (20)
Business Days prior written notice to Genzyme, and
(b) Genzyme shall have the right to terminate this Agreement,
effective upon written notice of termination to GTC in the event that:
8
(i) GTC fails to perform or observe or otherwise
breaches any of its material obligations under this Agreement or the
Purchase Agreement, and such failure or breach continues for a period
of sixty (60) days after written notice thereof to GTC from Genzyme;
(ii) GTC shall (A) seek the liquidation,
reorganization, dissolution, winding-up of itself or the composition or
readjustment of its debts, (B) apply for or consent to the appointment
of, or the taking of possession by, a receiver, custodian, trustee or
liquidator of itself or of all or a substantial part of its assets, (C)
make a general assignment for the benefit of its creditors, (D)
commence a voluntary case under the Bankruptcy Code, (E) file a
petition seeking to take advantage of any other law relating to
bankruptcy, insolvency, reorganization, wind-up or composition or
readjustment of debts, or (F) adopt any resolution of its stockholders
of Board of Directors for the purpose of effecting any of the
foregoing; or
(iii)a proceeding or case shall be commenced,
without the application or consent of GTC and such proceeding or case
shall continue undismissed, or an order, judgment or decree approving
or ordering any of the following shall be entered and continue unstayed
and in effect, for a period of forty-five (45) days from and after the
date service of process is effected upon GTC, seeking (A) GTC's
liquidation, reorganization, dissolution or winding-up, or the
composition or readjustment of its debts, (B) the appointment of a
trustee, receiver, custodian, liquidator or the like of GTC or of any
substantial part of its assets, or (C) similar relief in respect of GTC
under any law relating to bankruptcy, insolvency, reorganization,
winding-up or the composition or readjustment of debts.
Section 7.2. SURVIVAL OF RIGHTS AND DUTIES UNDER THE ORIGINAL
COLLABORATION AGREEMENT. No termination of this Agreement shall eliminate any
rights or duties of the Parties accrued prior to such termination. The
provisions of Articles 1, 4 and 5 and Sections 7.2 and 8.4 through 8.6
(inclusive) hereof shall survive any termination of this Agreement.
ARTICLE 8. MISCELLANEOUS
Section 8.1. FORCE MAJEURE. No Party shall be held liable or
responsible to any other Party, nor be deemed to have defaulted under or
breached this Agreement, for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected Party; PROVIDED, HOWEVER,
that the Party so affected shall use commercially reasonable efforts to avoid or
remove such causes of non-performance, and shall continue performance hereunder
with reasonable dispatch wherever such causes are removed. Each Party shall
provide the other Parties with prompt written notice of any delay or failure to
perform that occurs by reason of force majeure. The Parties shall seek mutually
and in good faith a resolution of the delay or the failure to perform.
Section 8.2. ASSIGNMENT. This Agreement may not be assigned or
otherwise transferred by any Party without the consent of the other Parties
(which consent shall not be unreasonably withheld or delayed) except: (a) that
any party may, without such consent, assign its rights and obligations under
this Agreement (i) in connection with a corporate reorganization, to any member
of an affiliated group, all or substantially all of the equity interest of which
is owned and controlled by such Party or its direct or indirect parent
corporation or (ii) in connection with a merger, consolidation or sale of
substantially all of such Party's assets to an unrelated Third Party, PROVIDED,
that such Party's rights and obligations under this Agreement shall be assumed
by its successor in interest in any such transaction and shall not be
transferred separate from all or substantially all of its other business assets,
including without limitation those business assets that are the subject of this
Agreement; and (b) without limiting the foregoing, GTC
9
may assign any of its rights and obligations hereunder to any Person in
connection with the assignment by GTC of all or a portion of its Member
Interest (as such term is defined in the amendment and restatement of the
Original Operating Agreement), PROVIDED that such assignee's rights and
obligations hereunder may not exceed GTC's rights and obligations hereunder.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement. Any purported assignment in violation of this Section 8.2 shall be
void.
Section 8.3. SEVERABILITY. Each Party hereby agrees that it does not
intend to violate any public policy, statutory or common laws, rules,
regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries. Should one or
more provisions of this Agreement be or become invalid, the Parties hereto shall
substitute, by mutual consent, valid provisions for such invalid provisions
which valid provisions in their economic effect are sufficiently similar to the
invalid provisions that it can be reasonably assumed that the Parties would have
entered into this Agreement with such valid provisions. In case such valid
provisions cannot be agreed upon, the invalidity of one or several provisions of
this Agreement shall not affect the validity of this Agreement as a whole,
unless otherwise specified herein or the invalid provisions are of such
essential importance to this Agreement that it is to be reasonably assumed that
the Parties would not have entered into this Agreement without the invalid
provisions.
Section 8.4. NOTICES. Any consent, notice or report required or
permitted to be given or made under this Agreement by one of the Parties to any
other Party shall be in writing, delivered personally or by facsimile (and
promptly confirmed by personal delivery or courier), by a next business day
delivery service of a nationally recognized overnight courier service or by
courier, postage prepaid (where applicable), addressed to such other Party at
its address indicated below, or to such other address as the addressee shall
have last furnished in writing to the addressor in accordance with this Section
8.2 and shall be effective upon receipt by the addressee.
If to GTC:
Genzyme Transgenics Corporation
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
Genzyme Transgenics Corporation
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: General Counsel
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇.
If to Genzyme: Genzyme Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President and Chief Executive Officer
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to: Genzyme Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
10
Attention: Chief Legal Officer
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇.
If to ATIII LLC: ATIII LLC
c/o
Genzyme Transgenics Corporation
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: General Manager, ATIII LLC
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
Genzyme Transgenics Corporation
▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: General Counsel
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇.
Section 8.5. APPLICABLE LAW. This Agreement shall be governed by and
construed in accordance with the laws of The Commonwealth of
Massachusetts
without regard to any choice of law principle that would dictate the application
of the laws of another jurisdiction.
Section 8.6. DISPUTES. Any disputes arising among or between the
Parties (other than between GTC and ATIII LLC) relating to, arising out of or in
any way connected with this Agreement or any term or condition hereof, or the
performance by any Party of its obligations hereunder, whether before or after
termination of this Agreement (a "DISPUTE"), shall be subject to the following:
(i) The representatives of the Parties will negotiate
in good faith for a period of not less than thirty (30) days to attempt to
resolve the dispute. Any unresolved dispute shall be presented promptly to the
chief executive officers of GTC and Genzyme or a designee of such chief
executive officer reasonably acceptable to such other Party. Such executives
shall meet or discuss in a telephone or video conference each of GTC and
Genzyme's view and explain the basis for such dispute.
(ii) If such executives cannot resolve such disagreement
within sixty (60) days after such issue has been referred to them, then such
dispute shall be referred to arbitration as described in the following clauses
(b) and (c).
(b) Any Dispute not settled as contemplated by clause (a)
above, shall be resolved, except as otherwise provided in this Section 8.6
solely and exclusively by binding arbitration. The arbitration shall be held in
Boston,
Massachusetts before a single arbitrator and shall be conducted in
accordance with the rules and regulations of the American Arbitration
Association unless specifically modified herein.
The Parties covenant and agree that the arbitration shall commence
within one hundred and twenty (120) days following the date on which any Party
files a written demand for arbitration. In connection with the arbitration
proceeding, the arbitrator shall have the power to order the production of
documents by each party and any third party witnesses. The Party to file a
written demand for arbitration shall deliver written notification of such filing
(the "NOTIFICATION") to the other Party(ies) party to such dispute within ten
(10) days of such filing. Each Notification will be deemed to have been sent on
the date it is postmarked and deemed to have been received three (3) days after
the date it is postmarked. In addition, each Party(ies) party to such dispute
may take up to three (3) depositions as of right, and the arbitrator may in his
or her discretion allow additional depositions upon good cause shown by the
moving party. However, the
11
arbitrator shall not have the power to order the answering of interrogatories or
the response to requests for admission. In connection with any arbitration, each
Party(ies) party to such dispute shall provide to the other party(ies) thereto,
no later than fifteen (15) Business Days before the date of the arbitration, the
identity of all persons that may testify at the arbitration and a copy of all
documents that may be introduced at the arbitration or considered or used by a
Party's witness or expert. The arbitrator's decision and award shall be made and
delivered within six (6) months of the selection of the arbitrator. The
arbitrator's decision shall set forth a reasoned basis for any award of damages
or finding of liability. The arbitrator shall not have the power to award
damages in excess of actual compensatory damages. Each Party hereby irrevocably
waives any claim to damages in excess of those damages provided for in this
Agreement.
The Parties covenant and agree that they will participate in the
arbitration of each Dispute to which they are, respectively, party in good faith
and that they will share equally its costs, except as otherwise provided in this
Agreement. The Parties shall bear their own attorneys' fees, costs and expenses
in connection with the arbitration. The Parties will share equally in the
arbitrator's fees and expenses, subject to the terms of this paragraph. The
arbitrator may in his or her discretion assess costs and expenses (including
reasonable legal fees and expenses of the prevailing party) against any party to
a proceeding. Any Party unsuccessfully refusing to comply with an order of the
arbitrator shall be liable for costs and expenses, including attorneys' fees,
incurred by the other Party(ies) to such Dispute in enforcing the award. This
Section 8.6 applies equally to requests for temporary, preliminary or permanent
injunctive relief, except that in the case of temporary or preliminary
injunctive relief any party may proceed in court without prior arbitration for
the limited purpose of avoiding immediate and irreparable harm. The provisions
of this Section 8.6 shall be enforceable in any court of competent jurisdiction.
Section 8.7. ENTIRE AGREEMENT: EFFECT ON ORIGINAL AGREEMENT; AMENDMENT.
This Agreement, together with the Purchase Agreement and the Services Agreement
of even date herewith and the exhibits and schedules hereto and thereto,
contains the entire understanding of the Parties with respect to the subject
matter hereof, and amends and restates the Original Collaboration Agreement in
its entirety and supercedes the letter of intent dated November 7, 2001 by and
between Genzyme and GTC and the Interim Funding Agreement dated March 28, 2001
by and among the Parties, as amended to date; PROVIDED, HOWEVER, that this
Agreement shall not affect the rights and obligations of the Parties under the
Collaboration Agreement dated as of February 3, 1999 among Genzyme (acting
through its Molecular Oncology division), GTC and ATIII LLC related to a
configuration of ATIII that inhibits angiogenesis, which shall remain in full
force and effect. All express or implied agreements and understandings, either
oral or written, heretofore made are expressly merged in and made a part of this
Agreement. Without limiting the foregoing, any provision of the Original
Collaboration Agreement not included in this Agreement is terminated as of the
date hereof. This Agreement may be amended, or any term hereof modified, only by
a written instrument duly executed by each of the Parties bound by the terms
hereof so amended or modified. Each Party hereby acknowledges that this
Agreement is the result of mutual negotiation and therefore any ambiguity in its
terms shall not be construed against any Party.
Section 8.8. HEADINGS. The captions to the several Articles and
Sections hereof are not a part of this Agreement, but are merely guides or
labels to assist in locating and reading the several Articles and Sections
hereof.
Section 8.9. INDEPENDENT CONTRACTORS. It is expressly agreed that GTC
and Genzyme shall be independent contractors and that, the relationship between
GTC and Genzyme shall not constitute a partnership, joint venture or agency.
Section 8.10.WAIVER. Except as expressly provided herein, the waiver
by any Party hereto of any right hereunder or of any failure to perform or any
breach by any other Party shall not be deemed a
12
waiver of any other right hereunder or of any other failure to perform or
breach by such other Party, whether of a similar nature or otherwise, nor shall
any singular or partial exercise of such right preclude any further exercise
thereof or the exercise of any other such right.
Section 8.11.COUNTERPARTS. This Agreement may be executed in two or
more counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument. One or more counterparts
of this Agreement may be delivered by telecopier, and shall have, and shall be
deemed to have, the same effects as an original counterpart hereof.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
13
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
GENZYME CORPORATION
By: /s/ Jan van Heek
Name: Jan van Heek
Title: Executive Vice President
GENZYME TRANSGENICS CORPORATION
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇
Name: ▇▇▇▇ ▇. ▇▇▇▇▇
Title: Vice President
ATIIILLC
By:
Genzyme Transgenics Corporation, its member
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇
Name: ▇▇▇▇ ▇. ▇▇▇▇▇
Title: Vice President
Schedule I
GENZYME PATENT RIGHTS
TITLE COUNTRY
1. [*****] U. S. Serial No. [*****]
Canada [*****]
Europe [*****]
2. [*****] U. S. Patent [*****]
Australia [*****]
Canada [*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Schedule 3.2
THIRD PARTY ROYALTIES AND FEES
1. Patent Sublicense Agreement dated February 1, 1990 by and between DNX, Inc.
("Chrysalis") and GTC (as successor to Genzyme).
2. Agreement dated September 20, 1990 by and among GTC (as successor to
Genzyme), SMI Genzyme Limited and Centeon (as successor to Behring
Aktiengesellschaf).
3. License Agreement dated December 26, 1990 by and between Pharming B.V. (as
successor to Biogen, Inc.) and GTC (as successor to Genzyme).
4. Cooperation Agreement dated September 6, 1988 by and between Tufts University
School of Veterinary Medicine and GTC (as successor to Genzyme, the successor
to Integrated Genetics, Inc.) as amended through and including September 6,
2000.