EXHIBIT 10.3
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE SUCH OMISSIONS.
SERVICES AGREEMENT
by and between
GENZYME CORPORATION
and
GENZYME TRANSGENICS CORPORATION
Dated as of July 31, 2001
SERVICES AGREEMENT
THIS SERVICES AGREEMENT (this "Agreement") dated as of July 31, 2001 (the
"Effective Date") is made by and between Genzyme Corporation, a Massachusetts
corporation having its principal place of business at Xxx Xxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("Genzyme"), and Genzyme Transgenics Corporation,
a Massachusetts corporation having its principal place of business at 000
Xxxxxxxx Xxxxxxxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx 00000 ("GTC"). Genzyme and GTC are
sometimes referred to herein individually as a "Party" and collectively as the
"Parties."
RECITALS
WHEREAS, GTC and Genzyme have entered into a Purchase Agreement of even
date herewith (the "Purchase Agreement") under which Genzyme has sold to GTC its
entire right, title and interest in ATIII LLC to GTC; and
WHEREAS, in connection therewith, GTC and Genzyme have contemporaneously
amended the Collaboration Agreement of ATIII LLC dated as of January 1, 1998 by
and among GTC, Genzyme and ATIII LLC (the "Original Collaboration Agreement") to
reflect the fact that GTC and Genzyme will no longer collaborate in the
development of Collaboration Products (as defined below) (as amended, the
"Amended Collaboration Agreement"); and
WHEREAS, GTC desires to purchase, and Genzyme desires to provide and
perform, certain Manufacturing Services and RD&R Services (each as defined
below) on the terms and conditions set forth in this Agreement.
NOW THEREFORE, in consideration of the premises and of the covenants herein
contained, the Parties mutually agree 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 fifty percent (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 power to elect or appoint more than fifty percent (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 GTC 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.
"DEVIATION" shall mean any variance from written specifications for
materials, components, equipment, facilities, test methods, or controls involved
in any aspect of producing, testing or labeling any Collaboration Product.
"EMEA" shall mean the European Medicines Evaluation Agency of the European
Union or any successor agency thereto.
"FACILITY" shall mean the portion of the manufacturing, testing and support
facilities operated by Genzyme at the following locations used in connection
with performing Manufacturing Services hereunder: (a) 00 Xxx Xxxx Xxxxxx,
Xxxxxxxxxx, XX 00000-0000, (b) 00 Xxx Xxxx Xxxxxx, Xxxxxxxxxx, XX 00000-0000,
(c) 00 Xxx Xxxx Xxxxxx, Xxxxxxxxxx, XX 00000-0000, (d) 0 Xxxxxxxx Xxxx,
Xxxxxxxxxx, XX 00000-0000, (e) 0 Xxxxxxxx Xxxx, Xxxxxxxxxx, XX 00000-0000 and
(f) Allston Landing, 000 Xxxxxxxx Xxxxx Xxxx, Xxxxxxx, XX 00000.
"FIELD" shall mean any and all indications for ATIII.
"FDA" shall mean the United States Food and Drug Administration or any
successor agency thereto.
"FULLY BURDENED COST OF GOODS" shall mean, with respect to any
Collaboration Products, (a) the variable costs and fixed costs incurred by
Genzyme or its Affiliates associated with the manufacture (inclusive of
finishing processes) and inventory of batches of such Collaboration Product or
(b) if such Collaboration Product is not manufactured by Genzyme or an Affiliate
thereof, the transfer price for batches of such Collaboration Product purchased
from the Third Party contractor and the cost of maintaining the inventory of
such batches of Collaboration Product. For purposes of this definition,
"variable costs" shall be deemed to be the cost of labor, raw materials,
supplies and other resources directly consumed in the manufacture and inventory
of batches of such Collaboration Product and all process validation and
revalidation and requalification costs. For purposes of this definition, "fixed
costs" shall be deemed to be the cost of facilities, utilities, insurance,
facility and equipment depreciation and other fixed costs directly related to
the manufacture and inventory of batches of such Collaboration Product. Fixed
costs shall be allocated to such Collaboration Product based upon the proportion
of such costs directly attributable to support of the manufacturing process and
inventory for such Collaboration Product. If any Facility or other facility is
used to manufacture Collaboration Products and products for other programs of
Genzyme, fixed costs shall be allocated in proportion to the actual use
(calculated based on the time such capacity is used) of such Facility or other
facility for the manufacture of Collaboration Products and products for such
other programs. Fully Burdened Cost of Goods shall exclude all costs otherwise
reimbursed by GTC pursuant to this Agreement. Except as otherwise provided in
this Agreement, all cost determinations made hereunder shall be made in
accordance with GAAP. It is agreed by the parties that in no event shall GTC be
responsible for any process revalidation costs directly resulting from
modifications made by Genzyme to its Facility located at 00 Xxx Xxxx Xxxxxx,
Xxxxxxxxxx, XX 00000-0000 in excess of an aggregate amount of [*****] dollars
(US$[*****]).
"FULLY BURDENED COST OF SERVICE" shall mean, with respect to any RD&R
Deliverable (as defined below), (a) the variable costs and fixed costs incurred
by Genzyme or its Affiliates associated with such
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Exchange Commission. Asterisks denote such omissions.
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RD&R Deliverable or (b) if such RD&R Deliverable is not prepared or produced by
Genzyme or an Affiliate thereof, the transfer price for such RD&R Deliverable
purchased from the Third Party contractor. For purposes of this definition,
"variable costs" shall be deemed to be the cost of labor, supplies and other
resources directly consumed in the preparation or production, as the case may
be, of such RD&R Deliverable and all process validation and revalidation and
requalification costs. For purposes of this definition, "fixed costs" shall be
deemed to be the cost of facilities and other fixed costs directly related to
the preparation or production, as the case may be, of such RD&R Deliverables.
Fixed costs shall be allocated to such RD&R Deliverable based upon the
proportion of such costs directly attributable to support of the preparation or
production of such RD&R Deliverable. If a facility is used to produce or prepare
RD&R Deliverables and products for other programs of Genzyme, fixed costs shall
be allocated in proportion to the actual use (calculated based on the time such
capacity is used) of such facility for the preparation and production of RD&R
Deliverables and such other products. Fully Burdened Cost of Service shall
exclude all costs otherwise reimbursed by GTC pursuant to this Agreement. Except
as otherwise provided in this Agreement, all cost determinations made hereunder
shall be made in accordance with GAAP. It is agreed by the parties that in no
event shall GTC be responsible for any process revalidation costs directly
resulting from modifications made by Genzyme to its Facility located at 00 Xxx
Xxxx Xxxxxx, Xxxxxxxxxx, XX 00000-0000 in excess of an aggregate amount of
[*****] dollars (US$[*****]).
"GAAP" shall mean United States generally accepted accounting principles,
consistently applied.
"GENZYME PATENT RIGHTS" shall have the meaning ascribed to it in the
Amended Collaboration Agreement.
"GENZYME TECHNOLOGY" shall have the meaning ascribed to it in the Amended
Collaboration Agreement.
"GENZYME/GTC PATENT RIGHTS" shall have the meaning ascribed to it in the
Amended Collaboration Agreement.
"GENZYME/GTC TECHNOLOGY" shall have the meaning ascribed to it in the
Amended Collaboration Agreement.
"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 Amended Collaboration Agreement.
"GTC MANUFACTURING SPECIFICATIONS" shall mean with respect to any
Collaboration Product, the written specifications for such Collaboration Product
(including the manufacturing thereof) determined by GTC and Genzyme to be set
forth in the Manufacturing Work Plan at the time such determination is made by
the Parties; PROVIDED, that such specifications shall at all times comply with
the relevant Regulatory Scheme in the country of sale and in the country of use.
"LIABILITY" shall mean any liability, losses, damages, costs, expenses
(including without limitation reasonable attorneys' fees and expenses), fees and
other amounts.
"MAA" shall mean a Marketing Authorization Application to be filed with the
EMEA.
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Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
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"MANUFACTURING COSTS" shall mean, with respect to any Manufacturing
Services, (i) Genzyme's Fully Burdened Cost of Goods plus (ii) a general and
administrative percentage calculated by dividing Genzyme's General Division's
actual general and administrative costs by the sum of (A) Genzyme General
Division's cost of goods sold (B) plus the increase in its inventory or minus
the decrease in its inventory, as the case may be (C) plus its research and
development expense (but in no event more than [*****] percent ([*****]%)).
"MANUFACTURING KNOW-HOW" shall have the meaning ascribed to it in the
Amended Collaboration Agreement.
"MANUFACTURING WORK PLAN" shall mean the detailed Manufacturing Work Plan
developed and signed by GTC and Genzyme, including any modifications, amendments
or updates thereto mutually agreed to in writing by GTC and Genzyme, specifying
the manufacturing services to be provided by Genzyme, which shall include,
without limitation: a detailed description of the manufacturing services for the
batch records requirements; periodic delivery requirements and delivery
instructions; a manufacturing schedule; a project schedule; a responsibility
matrix; and performance expectations. A copy of the initial Manufacturing Work
Plan, which covers Manufacturing Services to be provided during the period from
the Effective Date through December 31, 2001, is attached hereto as SCHEDULE I.
"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.
"RD&R DELIVERABLE" shall mean any item set forth in the RD&R Work Plan,
including without limitation any report, summary, proposal, application, test or
assay results (whether evidenced by a certificate or otherwise), clinical trials
or statistical analyses, or filing for or in connection with any Regulatory
Approval, or any draft or summary of, or other work product supporting or
arising from, the foregoing items, which item is to be delivered to GTC or to
any Third Party on behalf of GTC pursuant to the RD&R Work Plan.
"RD&R COSTS" shall mean, with respect to any RD&R Deliverable, (i)
Genzyme's Fully Burdened Cost of Service for such RD&R Deliverable plus (ii) a
general and administrative percentage calculated by dividing Genzyme's General
Division's actual general and administrative costs by the sum of (A) Genzyme
General Division's cost of goods sold (B) plus the increase in its inventory or
minus the decrease in its inventory, as the case may be (C) plus its research
and development expense (but in no event more than [*****] ([*****]%)).
"RD&R WORK PLAN" shall mean the research, development and regulatory
services Work Plan developed and signed by GTC and Genzyme, including any
modifications, amendments or updates thereto mutually agreed to in writing by
GTC and Genzyme, which shall include, without limitation: the RD&R Deliverables
and delivery schedules in connection with the MAA or other regulatory submission
to be made in respect of the Collaboration Product under the Regulatory Scheme.
A copy of the RD&R Work Plan, which covers RD&R Services to be provided during
the period from the Effective Date through December 31, 2001 is attached hereto
as SCHEDULE III.
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Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
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"REGULATORY APPROVALS" shall mean all approvals from regulatory authorities
in any country, which approvals are required to market lawfully Collaborative
Products in any such country, including without limitation any MAA and any
product pricing approvals where applicable.
"REGULATORY SCHEME" shall mean the United States Food, Drug and Cosmetic
Act and the United States Public Health Service Act and the regulations,
interpretations and guidelines promulgated thereunder by the FDA or the
regulatory scheme applicable to the Collaboration Products in any country other
than the United States, as such statutes, regulations, interpretations and
guidelines or regulatory schemes may be amended from time to time, including,
without limitation, the statutes, regulations, interpretations, and guidelines
administered by the FDA and the EMEA.
"SMIG TERRITORY" shall mean Japan, China, Taiwan, Thailand, India, Sri
Lanka, Indonesia, Philippines, Vietnam, Singapore, Malaysia, Hong Kong, Myanmar
(Burma), Xxxxxxxx, Xxxxxxxxxx, Xxxxx Xxxxx, Xxxx, Xxxxxxxx and their respective
succession states.
"TECHNOLOGY" shall have the meaning ascribed to it in the Amended
Collaboration Agreement.
"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.
Section 1.2 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
Amended Collaboration Agreement Recitals
ATIII LLC Preamble
cGMPs 8.2(a)
Dispute 10.7
Effective Date Preamble
FFDCA 8.2
Genzyme Preamble
GTC Preamble
Indemnitee 8.6
Indemnitor 8.6
Information 7.1
Inventions 5.4
Manufacturing Services 3.1
Notification 10.7
Original Collaboration Agreement Recitals
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TERM SECTION
Party/Parties Preamble
Project Manager 5.1
Publishing Party 7.3
Purchase Agreement Recitals
RD&R Services 4.1
Reviewing Party 7.3
U.S. dollars 6.3
ARTICLE 2. GRANTS AND RESERVATIONS OF RIGHTS
Section 2.1. LICENSES AND SUBLICENSE FROM GTC. GTC hereby grants to
Genzyme a non-exclusive, irrevocable (during the term of this Agreement),
royalty-free right and sublicense under (a) the Licenses (as defined in the
Amended Collaboration Agreement) granted to it pursuant to Section 3.1 the
Amended Collaboration Agreement and (b) the GTC Intellectual Property Rights and
the related Manufacturing Know-How owned or controlled by GTC, in each case
solely to the extent required to permit Genzyme to perform its duties under this
Agreement. GTC hereby grants to Genzyme a non-exclusive, irrevocable (during the
term of this Agreement), royalty-free right and license to use any and all
present and future trademarks owned or licensed (with the right to sublicense)
by GTC in connection with the commercialization of Collaboration Products in the
Territory solely to the extent required to permit Genzyme to perform its duties
under this Agreement.
Section 2.2. LICENSE FROM GENZYME. The Parties hereby acknowledge and
agree that the Genzyme Patent Rights and Genzyme Technology covering Inventions
arising as a result of and during the course of Genzyme's performance of the
Manufacturing Services or the RD&R Services hereunder are subject to the
Licenses granted by Genzyme to GTC under Section 3.1 of the Amended
Collaboration Agreement.
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ARTICLE 3. MANUFACTURING SERVICES
Section 3.1. PERFORMANCE OF SERVICES; AUDITS OF FACILITIES.
(a) Genzyme shall perform the manufacturing activities (the
"Manufacturing Services") set forth in the Manufacturing Work Plan attached
hereto as SCHEDULE I in accordance with the terms and conditions set forth
therein and herein. The Manufacturing Work Plan may be modified or amended from
time to time upon the mutual written agreement of the Parties. Any Manufacturing
Services in addition to those set forth in the Manufacturing Work Plan as it
existed on the Effective Date shall be subject to the availability of capacity
and personnel of Genzyme as reasonably determined by Genzyme. Genzyme covenants
that neither Genzyme nor any Third Party shall manufacture products in any
Facility or use any equipment integral thereto that makes any such Facility or
equipment unusable for the performance of the Manufacturing Services as agreed
upon in the Manufacturing Work Plan; PROVIDED, HOWEVER, that it is understood
and agreed that nothing herein shall prohibit Genzyme from modifying any
Facility in a manner that does not make such Facility unusable for the
performance of Manufacturing Services hereunder. Genzyme shall promptly notify
GTC of any modification to any Facility that will materially affect the
licensure of the Collaboration Products under the Regulatory Scheme. Genzyme
will keep GTC reasonably informed of all planned changes to the Facilities and
provide GTC with a reasonable opportunity to discuss such plans before they are
implemented, with it being understood and agreed by the parties that GTC's
approval shall not be required for any such changes. GTC acknowledges that
Genzyme will provide the Manufacturing Services in the Work Plan and that GTC
does not require that the Facilities will be reserved for FTC's exclusive use.
(b) GTC may conduct an audit of each Facility and Genzyme's operations at
its sole expense during regular business hours and upon reasonable advance
notice to Genzyme for the sole purpose of confirming that each Facility and
Genzyme's operations are reasonably suitable for the manufacture of
Collaboration Products, as long as such observation does not interfere with
Genzyme's operations at any such facility; PROVIDED, HOWEVER, that in no event
shall GTC conduct such audit of any Facility more once in each calendar year
during the period in which Genzyme performs Manufacturing Services under this
Agreement unless additional audits are reasonably necessary under the Regulatory
Scheme; PROVIDED FURTHER that notwithstanding the forgoing limitation on GTC's
rights to audit the Facilities, GTC shall have the right to audit any and all
modifications to any Facility within a reasonable amount of time after such
modifications are made.
Section 3.2. FORECASTS; PURCHASE ORDERS.
(a) No later than forty-five (45) days prior to the commencement of each
calendar quarter during the term of this Agreement, GTC shall provide a
non-binding written forecast to Genzyme stating the amount of the Collaboration
Products GTC reasonably anticipates it will purchase from Genzyme for each of
the next eight (8) calendar quarters, which forecast shall be broken out by
quarter for the first four (4) calendar quarters covered thereby. GTC has
delivered to Genzyme the initial forecast prior to the execution of this
Agreement.
(b) Annual firm purchase orders for Collaboration Products shall be
placed by GTC no later than the commencement of each calendar year during the
period in which Genzyme provides Manufacturing Services hereunder. The firm
purchase orders may differ from the forecast provided by GTC pursuant to clause
(a) above; PROVIDED, HOWEVER, that Genzyme shall not be obligated to supply GTC
in any given month in a calendar quarter amounts of Collaboration Products in
excess of
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[*****] percent ([*****] %) of the amount provided for such month in the most
recent annual forecast provided by GTC and in no event in excess of Genzyme's
capacity to manufacture Collaboration Products in the Facility as described in
the Manufacturing Work Plan. Firm purchase orders shall be delivered by GTC to
Genzyme's Manufacturing Project Manager (as defined below).
(c) Each firm purchase order shall include: (i) the quantity of
Collaboration Products to be purchased; (ii) the requested delivery date(s)
therefor; (iii) any relevant shipping instructions; and (iv) any other
information dictated by the circumstances of the order. Genzyme shall accept
purchase orders issued to it by GTC that are within the amounts allowed by the
restrictions set forth in clause (b) above within five (5) Business Days after
receipt of such purchase order. Genzyme shall use commercially reasonable
efforts to ship Collaboration Products to GTC or its designee in accordance with
the terms of the purchase order.
Section 3.3. MODIFICATIONS OF MANUFACTURING PROCESS.
(a) Genzyme will use commercially reasonable efforts to contact promptly
the GTC Manufacturing Project Manager (as defined below) in the event of a
Deviation in the manufacture of Collaboration Products from the Manufacturing
Work Plan (whether actual, expected or anticipated) that could impact the
safety, identity, strength, quality or purity of any Collaboration Product.
Genzyme shall notify the GTC Manufacturing Project Manager in writing of any
such Deviation within two (2) Business Days after the occurrence of such
Deviation.
(b) Upon receipt by GTC of Genzyme's notice pursuant to clause (a) above
or upon GTC's independent observation or awareness of any such Deviation, the
Parties' Manufacturing Project Managers shall meet within five (5) Business Days
after such notice or observation, as the case may be, to determine the course of
performance thereafter. The agenda for such meeting shall include, without
limitation, an assessment of such Deviation and possible solutions and the
development of a plan to correct the Deviation, including a mutually agreeable
time frame for such correction, and a plan for reporting such Deviation, if
necessary, to the applicable regulatory authorities. Genzyme and GTC shall
undertake all commercially reasonable efforts to remedy any Deviation from the
Manufacturing Work Plan.
Section 3.4. CERTIFICATES.
(a) Genzyme shall perform, or cause its contract manufacturer(s) to
perform, quality assurance and control tests on each lot of Collaboration
Products finish processed pursuant to this Agreement before delivery and shall
prepare, or cause its contract manufacturer(s) to prepare and deliver, a written
report of the results of such tests. Each test report shall set forth for each
lot delivered the items tested, specifications and results in a certificate of
analysis containing the types of information that shall have been approved by
GTC and are in compliance with acceptance criteria submitted to the FDA or other
applicable regulatory authority. Genzyme shall maintain such certificates for a
period of not less than seven (7) years from the date of expiration of such
batch of Collaboration Product, or such longer period as may be required under
the applicable requirements of the applicable Regulatory Scheme.
(b) Genzyme shall prepare and maintain, or cause its contract
manufacturer(s) to prepare and deliver to Genzyme, for a period of not less than
seven (7) years from the date of expiration of each lot of Collaboration
Products or such longer period as may be required under applicable requirements
of the applicable Regulatory Scheme for each lot of Collaboration Products
manufactured hereunder a certificate
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Exchange Commission. Asterisks denote such omissions.
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of compliance containing the types of information which shall have been approved
by GTC or required by the FDA or other applicable regulatory authority, which
certificate will certify that the lot of Collaboration Products was manufactured
in compliance with acceptance criteria submitted to the FDA or other regulatory
authority.
(c) Upon the expiration of any seven (7)-year period (or such longer
period as may be required under the applicable requirements of the applicable
Regulatory Scheme) referenced in the foregoing clauses (a) and (b), Genzyme
shall, and shall cause its contract manufacturer(s) to, notify GTC of the expiry
of such period and upon receipt of GTC's written instructions therefor to either
destroy or deliver to GTC at GTC's expense, all such certificates; PROVIDED,
that if GTC does not provide written directions within fifteen (15) Business
Days of receiving the relevant notice, Genzyme shall deliver at GTC's expense
the applicable certificates to GTC in accordance with the appropriate delivery
instructions contained in the Manufacturing Work Plan.
Section 3.5. ACCESS TO RECORDS AND FACILITIES; CLINICAL AND REGULATORY
AUDITS.
(a) Genzyme shall permit GTC to have access during regular business hours
and upon reasonable advance notice, at GTC's expense and no more than twice in
each calendar year during the term of this Agreement, to those records and
supporting documentation of Genzyme, to the extent necessary to substantiate all
of Genzyme's Fully Burdened Costs of Goods, billing invoices, adjustments and
other matters pertaining to the performance of Genzyme under this Agreement and
those records and supporting documentation of Genzyme for three (3) years prior
to the date of this Agreement solely to the extent that they contain information
that may affect charges and costs under this Agreement. Genzyme shall maintain
such records and supporting documentation for a period of three (3) years from
the date thereof.
(b) GTC shall have the right, at its own expense to have a reasonable
number of GTC employees or representatives enter each Facility or the facility
of Genzyme's contract manufacturer(s), as the case may be, solely to observe
activities relating to the manufacture of Collaboration Products and the
documentation of such Manufacturing Services and any other activity incidental
thereto during regular business hours and upon reasonable advance notice and no
more than twice in each calendar year during the term of this Agreement, as long
as such observation does not interfere with Genzyme's operations at any such
Facility; PROVIDED, HOWEVER, that such GTC personnel shall be subject to the
supervision of Genzyme while present in such Facility or facility as the case
may be, and shall adhere to Genzyme's safety policies and the safety and
confidentiality requirements of Genzyme's contract manufacturer(s), as
applicable; PROVIDED FURTHER that GTC's right to enter the facility of Genzyme's
contract manufacturer(s) shall be subject to the authorization by such contract
manufacturer(s).
(c) Genzyme shall permit a reasonable number of GTC employees or
representatives of GTC to have access during regular business hours and upon
reasonable advance notice, at GTC's own expense and no more than twice in each
calendar year during the term of this Agreement, to audit Genzyme's records
relating to the Manufacturing Services for the purpose of monitoring compliance
with Manufacturing Work Plan, cGMPs and other requirements of the applicable
Regulatory Scheme.
(d) Genzyme shall advise GTC immediately if an authorized agent of the
FDA or other regulatory authority visits any of Genzyme's manufacturing
facilities, including, without limitation, any Facility, or any other facilities
at which Collaboration Products are manufactured by Genzyme's contract
manufacturers, for an inspection with respect to the Collaboration Products.
Genzyme shall furnish, or cause the appropriate Third Party to furnish, to GTC
the report by such regulatory authority of such visit, to the extent that such
report relates to Collaboration Products, within fifteen (15) Business Days
after Genzyme's receipt of such report.
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(e) Notwithstanding anything to the contrary in this Agreement, GTC may
not designate any Third Parties (other than agents of the FDA or other
regulatory authorities) to visit any of Genzyme's manufacturing facilities
without the prior written consent of Genzyme, which consent shall not be
unreasonably withheld or delayed. Any such Third Party shall be required to
execute a confidentiality agreement reasonably acceptable to Genzyme prior to
such visit.
Section 3.6. TECHNOLOGY TRANSFER PROJECT. GTC shall use its reasonable
efforts to select and qualify a Third Party to manufacture the Collaboration
Products and perform the Manufacturing Services by no later than six (6) months
prior to the expiration of the term of this Agreement set forth in Section
9.1(ii) hereof. Genzyme shall, at GTC's expense, reasonably cooperate with GTC
during the term of this Agreement to provide advice in the selection and
validation of Third Party vendors and such technical assistance as may be
necessary in connection with the transfer of the Manufacturing Services to the
Third Party vendor selected and qualified by GTC as a manufacturer of the
Collaboration Products. Genzyme shall use its reasonable efforts to develop and
deliver the reasonable deliverables set forth in SCHEDULE II hereto and such
other deliverables as may be identified and mutually agreed upon by the Parties
in writing in connection with the transfer of Manufacturing Services to such
Third Party vendor. Genzyme shall provide advice with respect to the selection
and validation of a Third Party vendor in good faith upon GTC's request pursuant
to this Section 3.6 but shall have no liability to GTC, its Affiliates or any
Third Parties with respect thereto whatsoever.
ARTICLE 4. RESEARCH, DEVELOPMENT AND REGULATORY SERVICES
Section 4.1. RESEARCH, DEVELOPMENT AND REGULATORY SERVICES.
(a) PERFORMANCE OF SERVICES. Genzyme hereby agrees to provide the
research, development and regulatory services for the preparation, production
and delivery of the RD&R Deliverables in connection with certain Regulatory
Approval filings in the Territory for certain Collaboration Products in the name
of GTC or in the name of such other entity as GTC may direct in writing, all as
set forth in the RD&R Work Plan set forth in SCHEDULE III hereto (such services,
collectively, the "RD&R Services"). The RD&R Work Plan may be modified or
amended from time to time upon the mutual written agreement of the Parties. Any
RD&R Services in addition to those set forth in the initial RD&R Work Plan shall
be subject to the availability of Genzyme's capacity and personnel, as
determined by Genzyme in its sole discretion. Prior to any submission to the
EMEA or any other authority under the applicable Regulatory Scheme, or with
respect to any other Regulatory Approval, the Parties' European Project Managers
or U.S. Regulatory Project Managers, as applicable (each as defined below),
shall consult on, and GTC shall approve in writing, the content and scope of
such Regulatory Approval filings.
(b) DELIVERY. Genzyme shall deliver all RD&R Deliverables in accordance
with the instructions contained in the RD&R Work Plan. GTC shall reimburse
Genzyme for all delivery expenses (including, without limitation, filing fees,
as applicable) incurred by Genzyme in connection therewith.
(c) MODIFICATION OF RD&R SERVICES. GTC shall approve all methodologies,
reports, filings and timelines. Genzyme shall not change the reports, filings,
timelines or methodologies set forth in RD&R Work Plan without the prior written
consent of GTC, which consent shall not be unreasonably withheld or delayed.
Genzyme will use commercially reasonable efforts to contact promptly, but in no
event later than two (2) Business Days following the occurrence of any such
deviation, the GTC Project Coordinator in the event of any deviation from the
RD&R Work Plan (whether actual, expected or anticipated) that could impact any
Regulatory Approval or filings for the Collaboration Products as contemplated by
the RD&R Work Plan. Upon receipt by GTC of Genzyme's notice pursuant to the
preceding sentence or upon GTC's independent observation or awareness of such
deviation, the
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appropriate Project Managers of the Parties shall meet within two (2) Business
Days of such notice to determine the course of performance thereafter. The
agenda for such meeting shall include, without limitation, an assessment of such
deviation and possible solutions and the development of a plan to correct such
deviation that shall include a mutually agreeable timeframe for such correction.
Genzyme shall use best efforts to remedy any deviation from the RD&R Work Plan,
including, without limitation, the timing of any filing specified therein.
Section 4.2. CERTIFICATES AND ACCESS; RECORDS.
(a) Each RD&R Deliverable that is test, assay report or technical report
prepared by or on behalf of Genzyme shall set forth the items tested,
specifications and results in a certificate of analysis or report, as the case
may be, containing the types of information that shall have been approved by GTC
or required by the FDA or other applicable regulatory authority. Genzyme shall
maintain such certificates and/or reports for the later to terminate of a period
of not less than seven (7) years from the date of performance or for such longer
period as may be required under applicable requirements of the applicable
Regulatory Scheme.
(b) Genzyme shall permit a reasonable number of GTC employees or
representatives to have access during regular business hours and upon reasonable
advance notice, at GTC's own expense and no more than twice in each calendar
year during the term of this Agreement, to those records and supporting
documentation of Genzyme, to the extent necessary to substantiate all of
Genzyme's Fully Burdened Costs of Services, billing invoices, adjustments and
other matters pertaining to the performance of Genzyme under this Agreement and
those records supporting documentation for three (3) years prior to the date of
this Agreement solely to the extent that they contain information that may
affect charges and costs under this Agreement. Genzyme shall maintain such
records and supporting documentation for a period of three (3) years from the
date thereof.
(c) Upon the expiration of any seven (7)-year period referenced in the
foregoing clause (a), Genzyme shall, and shall cause its contractors, if any,
to, notify GTC of the expiry of such period and to either destroy or deliver to
GTC, at GTC's written direction, all such certificates and/or reports; PROVIDED,
that if GTC does not provide written directions within fifteen (15) Business
Days of receiving the relevant notice, Genzyme shall deliver at GTC's expense
the certificates and/or reports in accordance with the appropriate delivery
instructions contained in the RD&R Work Plan.
(d) Genzyme shall permit a reasonable number of GTC employees or
representatives during regular business hours and upon reasonable advance
notice, at GTC's own expense and no more than twice in each calendar year during
the term of this Agreement, to audit Genzyme's records and facilities relating
to the RD&R Services for the sole purpose of monitoring compliance with the RD&R
Work Plan and the applicable requirements of the Regulatory Scheme, as long as
such observation does not interfere with Genzyme's operations; PROVIDED,
HOWEVER, that such GTC personnel shall be subject to the supervision of Genzyme
while present in such facilities and shall adhere with Genzyme's safety
policies.
ARTICLE 5. GENERAL PROVISIONS FOR SERVICES
Section 5.1. PROJECT MANAGEMENT.
(a) GTC and Genzyme have each appointed a (i) a project manager for the
Manufacturing Services (the "Manufacturing Project Managers"), (ii) a project
manager for the European clinical and regulatory portion of the RD&R Services
(the "European Project Managers"), (iii) a project manager for U.S. regulatory
portions of the RD&R Service (the "US Regulatory Project Managers"), (iv) a
project
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manager for research and development portion of the RD&R Services (the "Research
Project Managers"), (v) a project manager for the U.S. clinical portion of the
RD&R Services (the "U.S. Clinical Project Managers") and (vi) an overall
coordinator for the Manufacturing and RD&R Services (the "Project
Coordinators"). The initial Project Managers and Project Coordinators are
identified in Schedule IV hereto. Each Party may change any of its Project
Managers or its Project Coordinator at any time in its sole discretion by
delivery written notice of such change to the other Party.
(b) The Project Managers shall have the authority of GTC and Genzyme, as
applicable, to resolve disputes between GTC and Genzyme with respect to the
day-to-day execution of relevant portions of the Manufacturing Work Plan and the
RD&R Work Plan. In addition, the Project Managers and the Project Coordinators
shall advise and instruct one another concerning all aspects of performance
under this Agreement except as otherwise provided herein, in the Manufacturing
Work Plan or the RD&R Work Plan or determined by GTC and Genzyme.
The Project Managers and the Project Coordinators shall meet with their
counterparts regularly and at least on a monthly basis during the performance of
Manufacturing Services and RD&R Services, as applicable. Additional meetings may
be scheduled as the Project Managers and Project Coordinators may mutually
determine as necessary or advisable. Except as otherwise agreed by Genzyme and
GTC, each meeting's agenda shall include, without limitation, the review and
on-going update of the Manufacturing Work Plan and RD&R Work Plan, as the case
may be, subject to Sections 3.1(a) and 4.1(a). The Project Managers and the
Project Coordinators, respectively, will prepare jointly minutes of each such
meeting and distribute such minutes to GTC and Genzyme within five (5) Business
Days after each such meeting. The Project Coordinators, in consultation with the
Project Managers, shall oversee monthly update memos and quarterly reporting on
the Manufacturing Services and RD&R Services, which update memos and reports
shall include such data, and be deliverable on such dates, as set forth in the
Manufacturing and RD&R Work Plans.
Section 5.2 SUBCONTRACTS. GTC acknowledges and agrees that, in
performing services hereunder, that Genzyme may, and is hereby authorized to,
engage or agree or otherwise collaborate with other Third Parties, including,
without limitation, its Affiliates or research institutions performing other
research and development activities for such party, to provide assistance in
carrying out the services to be provided hereunder to the extent provided in or
contemplated by the Manufacturing Work Plan and the Regulatory Work Plan.
Genzyme shall use its reasonable efforts to cause its contract manufacturer(s)
to authorize GTC's employees and representatives to have access to their
facilities in which Collaboration Products are manufactured as contemplated by
Section 3.5 above.
Section 5.3 OWNERSHIP OF INVENTIONS. Genzyme and GTC understand and
agree that all right, title and interest to any (i) writings, inventions,
know-how, discoveries, improvements and other technology, whether or not
patentable or copyrightable, and any patent applications, patents or copyrights
based thereon (collectively, "Inventions") and (ii) data and information
developed at least in part by, or on behalf of, Genzyme pursuant to this
Agreement or in the course of performing Manufacturing Services and/or RD&R
Services under this Agreement shall vest in Genzyme. It is understood that all
of the aforementioned Inventions, data and information are subject to the
license granted by Genzyme to GTC pursuant to Section 3.1 of the Amended
Collaboration Agreement.
Section 5.4 CONSISTENCY WITH REGULATORY REQUIREMENTS AND APPLICABLE LAWS
AND REGULATIONS. Notwithstanding anything to the contrary in this Agreement, in
no event shall Genzyme be required under the Manufacturing Work Plan, the RD&R
Work Plan or otherwise to perform any element of the Manufacturing Services or
the RD&R Services in a manner that is inconsistent with the applicable
requirements of the Regulatory Scheme or other applicable laws or regulations.
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ARTICLE 6. PAYMENT TERMS
Section 6.1 PRICE.
(a) For the Manufacturing Services, Genzyme shall charge GTC an
amount equal to the Manufacturing Costs plus and additional [*****] percent
([*****]%) of such Manufacturing Costs.
(b) For the R&D Services, Genzyme Shall Charge GTC an amount
equal to Rd&R Costs plus and additional [*****] percent ( [*****]%) of such RD&R
Costs.
Section 6.2 INVOICES. Genzyme shall issue an invoice to GTC on a monthly
basis for the Manufacturing Services and RD&R Services provided during such
calendar month. Payment terms are net forty-five (45) days from GTC's receipt of
the invoice. Each invoice shall contain the detail described in SCHEDULE V
hereto.
Section 6.3 METHOD OF PAYMENT. All payments to be made under this
Agreement shall be payable in U.S. dollars by check or wire transfer in
immediately available funds to such account(s) as Genzyme may designate in
writing to GTC. For purposes of this Agreement, "U.S. dollars" shall mean United
States dollars and any success or currency thereof as the lawful currency of the
United States of America.
Section 6.4 LATE PAYMENTS. In the event that any payment due from GTC
under this Article 1 is not made within ten (10) business days after such
payment is due, interest shall accrue on such late payment from the date on
which such amount became due at a rate per annum equal to the two (2) plus the
prime rate established by Fleet National Bank, N.A. in Boston,
Massachusetts, or
at a lower rate if required by applicable law, calculated on the number of days
that lapse until such amount is paid in full.
ARTICLE 7. CONFIDENTIALITY
Section 7.1. NONDISCLOSURE OBLIGATIONS. Except as otherwise provided in
this Article 7, 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
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
- 13 -
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 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. The Parties
hereby acknowledge and agree that the records, books and supporting
documentation provided to or reviewed by GTC with respect to the Manufacturing
Costs and the RD&R Costs shall be deemed to be Genzyme's confidential
Information.
Section 7.2. TERMS OF THIS AGREEMENT. The Parties further agree that the
terms of this Agreement shall be deemed to be confidential and shall not be
disclosed except as expressly permitted in this Section 7.2. Except as otherwise
required by applicable law, each Party agrees not to disclose any terms or
conditions of this Agreement to any Third Party without the prior consent of the
other Party (which consent shall not be unreasonably withheld or delayed);
PROVIDED, HOWEVER, 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 Amended Collaboration Agreement
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.
Section 7.3. PUBLICATIONS.
(a) Each Party recognizes the mutual interest in obtaining valid patent
protection. Consequently, either Party and its Affiliates and their respective
employees, consultants and Third Party contractors wishing to make a publication
(including, without limitation, any oral disclosure made without obligation of
confidentiality) relating to work performed by Genzyme as part of the
Manufacturing Services and/or the RD&R Services (the "Publishing Party") shall
transmit to the other Party (the "Reviewing Party") a copy of the proposed
written publication at least forty-five (45) days prior to submission for
publications, or an abstract of such oral disclosure at least fifteen (15)
Business Days prior to submission of the abstract or the oral disclosure,
whichever is earlier. The Reviewing Party shall have the right to (i) request a
delay in publication or presentation in order to protect patentable information,
(ii) propose modifications to the publication for patent reasons or (iii)
request that the information be maintained as a trade secret.
(b) If the Reviewing Party requests a delay as described in clause (a)(i)
above, the Publishing Party shall delay submission or presentation of the
publication for a period of ninety (90) days to enable patent applications
protecting each Party's rights in such information to be filed. Upon the
expiration of forty-five (45) days, in the case of proposed written disclosures,
or fifteen (15) Business Days in the case of an abstract of proposed oral
disclosure, from transmission of such proposed disclosures to the
- 14 -
Reviewing Party, the Publishing Party shall be free to proceed with the written
publication or the oral presentations, respectively, unless the Reviewing Party
has requested the delay described above.
(c) To the extent possible in the reasonable exercise of its discretion,
the Publishing Party shall incorporate all modifications proposed under clause
(a)(ii) above. If a trade secret that is the subject of a request made under
clause (a)(iii) above cannot be otherwise protected without unreasonable expense
to the Reviewing Party, such information shall be omitted from the publication.
ARTICLE 8. REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
Section 8.1. 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 8.2. GENZYME'S REPRESENTATIONS AND WARRANTIES. Genzyme hereby
represents, warrants and covenants to and with GTC as follows:
(a) The Collaboration Products manufactured, sold and delivered pursuant
to this Agreement shall be manufactured and delivered in accordance with (i) the
current Good Manufacturing Practices promulgated by the FDA or other applicable
regulatory authority ("cGMPs") and (ii) after such time as the GTC Manufacturing
Specifications are mutually determined by the Parties and added to the
Manufacturing Work Plan in accordance with Section 1.1(a) hereof, in accordance
with the GTC Manufacturing Specifications set forth in SCHEDULE I hereto and any
changes thereto as may be mutually agreed upon in writing by the Parties from
time to time. Genzyme further warrants that the Collaboration Products delivered
by Genzyme shall conform in all material respects to any applicable requirements
of the Regulatory Scheme regarding the manufacture of the Collaboration
Products. Notwithstanding the foregoing, Genzyme's representations and
warranties hereunder do not extend to any acts or omissions by Genzyme or its
Affiliates or contract manufacturer(s) as a result of directions or instructions
provided by GTC as to the manner in which the Manufacturing Services are to be
performed, including without limitation the Manufacturing Work Plan and the GTC
Manufacturing Specifications.
(b) All Collaboration Products delivered to GTC pursuant to this
Agreement, at the time of such delivery, shall not be adulterated within the
meaning of the Federal Food, Drug and Cosmetic Act, as amended ("FFDCA"), or
within the meaning of any applicable state or municipal law in which the
definition of adulteration is substantially the same as that contained in the
FFDCA, as the FFDCA and such laws are constituted and effective at the time of
delivery, and will not be an article which may not, under the provisions of the
FFDCA, be introduced into interstate commerce. Notwithstanding the foregoing,
Genzyme's representation and warranty hereunder does not extend to any packaging
or labeling provided by, or at the direction of, GTC or to any acts or omissions
by Genzyme or its Affiliates or contract manufacturer(s) as a result of
directions or instructions provided by GTC as to the manner in which the
Manufacturing Services are to be performed, including without limitation the
Manufacturing Work Plan and the GTC Manufacturing Specifications.
- 15 -
(c) All activities associated with the operation of each Facility will be
conducted in accordance with all applicable laws except to the extent that such
failure to comply therewith would not have a material adverse effect on
Genzyme's performance of its obligations under this Agreement.
(d) All aspects of the RD&R Services will be conducted in accordance with
the Regulatory Scheme and all other applicable federal, state, local and foreign
statute, law, ordinance, regulation, rule, code, or any order, writ, judgment,
injunction, decree, stipulation, determination or award entered by any
governmental authority, or any guideline, interpretation and other requirement
or rule of law. Notwithstanding the foregoing, Genzyme's representation and
warranty hereunder does not extend to any acts or omissions by Genzyme, its
Affiliates or vendors as a direct result of directions or instructions provided
by GTC as to the manner in which the RD&R Services are to be performed or
delivered, including without limitation the RD&R Work Plan.
(e) All RD&R Deliverables to be filed pursuant to the Regulatory Scheme
will be prepared and produced in accordance with the Regulatory Scheme and other
applicable federal, state, local and foreign statute, law, ordinance,
regulation, rule, code, or any order, writ, judgment, injunction, decree,
stipulation, determination or award entered by any governmental authority, or
any guideline, interpretation and other requirement or rule of law.
Notwithstanding the foregoing, Genzyme's representation and warranty hereunder
does not extend to any acts or omissions by Genzyme, its Affiliates or vendors
as a direct result of directions or instructions provided by GTC as to the
manner in which the RD&R Services are to be performed or delivered, including
without limitation the RD&R Work Plan.
Section 8.3. DISCLAIMER OF WARRANTIES. THE LIMITED WARRANTIES CONTAINED
IN SECTION 8.2 ARE THE SOLE WARRANTIES WITH RESPECT TO THE COLLAOBRATION
PRODUCT, THE MANUFACTURING SERVICES, THE RD&R SERVICES AND THE RD&R DELIVERABLES
SUPPLIED, DELIVERED OR PERFORMED BY GENZYME AND ARE MADE EXPRESSLY IN LIEU OF
AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR NON-INFRINGEMENT OF THIRD PARTY RIGHTS AND ALL OTHER EXPRESS OR
IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW OR STATUTE. GTC
ASSUMES ALL RISK WHATSOEVER AS TO THE USE OF THE COLLABORATION PRODUCT AND THE
RD&R DELIVERABLES, WHETHER USED SINGLY OR IN COMBINATION WITH OTHER SUBSTANCES
OR MATERIALS.
Section 8.4. LIMITATION ON LIABILITY. NEITHER PARTY SHALL BE LIABLE TO
THE OTHER FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR
PUNITIVE DAMAGES.
Section 8.5. INDEMNIFICATION.
(a) GENZYME'S INDEMNIFICATION OBLIGATIONS. Genzyme will indemnify and
hold GTC harmless against any and all Liabilities resulting from (i) any Third
Party claims made or suits brought against GTC to the extent such Liability
arises from Genzyme's gross negligence or willful misconduct in the performance
of the Manufacturing Services or the RD&R Services or (ii) any breach of any
representation or warranty made by Genzyme in this Agreement; PROVIDED, HOWEVER,
that such indemnification shall not extend to any Liabilities resulting from (x)
any acts or omissions by Genzyme as a direct result of directions or
instructions provided by GTC as to the manner in which the Manufacturing
Services or the RD&D Services are to be performed, including without limitation
the GTC Manufacturing Specifications, the Manufacturing Work Plan and the RD&R
Work Plan or (y) the gross negligence or willful misconduct of GTC.
- 16 -
(b) GTC'S INDEMNIFICATION OBLIGATIONS. GTC will indemnify and hold
Genzyme harmless against any and all Liabilities resulting from (i) any
packaging or labeling of the Collaboration Products to the extent that such
packaging or labeling has been supplied by or at the direction of GTC and
applied in accordance with instructions from GTC, (ii) any Third Party claims
made or suits brought against Genzyme to the extent such Liability arises from
GTC's breach of any provision of this Agreement or its gross negligence or
willful misconduct, (iii) any representation or warranty made by GTC to its
customers or users with respect to the Collaboration Products other than
representations or warranties that (A) the Collaboration Products are not, at
the time of delivery by Genzyme to GTC, adulterated within the meaning of the
FFDCA or within the meaning of any applicable state or municipal law in which
the definition of adulteration is substantially the same as that contained in
the FFDCA and (B) will not be an article that may not, under the provisions of
the FFDCA, be introduced into interstate commerce, (iv) the use of the
Collaboration Product for any purpose, including without limitation any use
contemplated under this Agreement or the Amended Collaboration Agreement, (v)
the manufacture of the Collaboration Product according to the GTC Manufacturing
Specifications, (vi) after delivery of the Collaboration Product by Genzyme to
GTC (or GTC's designee), the handling, storage, testing, transportation,
promotion, distribution, sale, use, treatment or disposal of the Collaboration
Product, (vii) visits by GTC's representatives to the Facilities or the
facilities of Genzyme's contract manufacturer(s), (viii) alleged design,
trademark, trade name or copyright infringement resulting from the use of any
design, trademark, trade name, copyright or part thereof, appearing on the
Collaboration Products at GTC's request or (ix) patent or copyright infringement
based on the manufacture, sale or use of the Collaboration Products manufactured
by Genzyme pursuant to this Agreement; PROVIDED, HOWEVER, that such
indemnification shall not extend to any such Liabilities resulting from the
gross negligence or willful misconduct of Genzyme.
(c) INDEMNIFICATION PROCEDURES. GTC, Genzyme, any of their respective
Affiliates, or their respective employees or agents that intends to claim
indemnification under this Section 8.5 (each, in such capacity, an "Indemnitee")
shall promptly notify the other Party (in such capacity, the "Indemnitor") of
any Liability in respect of which such Indemnitee intends to claim such
indemnification reasonably promptly after such Indemnitee is aware thereof, and
the Indemnitor shall assume the defense of any related Third Party action, suit
or proceeding with counsel mutually satisfactory to such parties; PROVIDED,
HOWEVER, that such Indemnitee shall have the right to retain its own counsel,
with the fees and expenses to be paid by the Indemnitor, if representation of
such Indemnitee by the counsel retained by the Indemnitor would be inappropriate
due to actual or potential conflicting interests between such Indemnitee and any
other party represented by such counsel in such proceedings. In any claim or
suit in which an Indemnitee seeks indemnification from the Indemnitor, the
Indemnitee shall not settle, offer to settle or admit liability or damages in
any such claim or suit without the prior written consent of the Indemnitor,
which consent shall not be unreasonably withheld or delayed. The indemnity
agreement in clause (a) or (b) above, as the case may be, shall not apply to
amounts paid in settlement of any claim, loss, damage or expense if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be unreasonably withheld or delayed. The failure of an Indemnitee to
deliver notice to the Indemnitor within a reasonable time after becoming aware
of such matter, if materially prejudicial to the Indemnitor's ability to defend
such action, shall relieve the Indemnitor of such liability to the Indemnitee
under clause (a) or (b) above, as the case may be. Each Indemnitee and its
employees and agents shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any matter covered by this
indemnification. The Indemnitor shall additionally be liable to pay any
reasonable attorneys' fees and expenses incurred by any Indemnitee in
establishing a successful claim for indemnity hereunder.
Section 8.6. INSURANCE. Each Party shall maintain the following insurance
policies or self insurance that is adequately funded in accordance with sound
actuarial principles and in accordance with any applicable statutory
requirements: Commercial General Liability insurance, including contractual
- 17 -
liability coverage, in an amount not less than [*****] U.S. dollars
(U.S.$[*****]) per occurrence and [*****] U.S. dollars (U.S.$[*****]) annual
aggregate; and naming the other Parties' Indemnitees as specified in this
Agreement, additional insured as their interests may appear. In addition,
Genzyme shall maintain Products Liability insurance applicable to the
manufacture of any Collaboration Products under this Agreement in accordance
with the following milestones: (i) as of the date of this Agreement, Genzyme
will have in full force and effect Primary Products Liability Insurance for
Human Clinical Trials in an amount not less than [*****]U.S. dollars
(U.S.$[*****]) per occurrence and in the aggregate, with defense costs within
the limits, and said coverage shall continue to be in effect for not less than
[*****]; (ii) as of the date on which GTC or its Affiliate or collaborative
partner receives marketing authorization for the first Collaboration Product,
Genzyme will have in full force and effect Products and Completed Operations
Liability Insurance in an amount not less than [*****] U.S. dollars
(U.S.$[*****]) per occurrence and in the aggregate with defense costs within the
limits, and said policy shall continue to be in effect for not less than
[*****]. Each such Products Liability policy shall name GTC and its Indemnitees
as specified in this Agreement, additional insureds. Each Party shall provide
the other upon written request , a certificate of insurance or evidence of
appropriate self-insurance, as applicable as evidence of the insurance required
herein and said certificate shall provide not less than thirty (30) days notice
of cancellation, termination, non-renewal or a material change which reduces the
terms and conditions of the coverage below that required in this Agreement. Each
Party's insurance shall be written as primary policy coverage and not
contributing with, nor in excess of, any insurance which any other Party shall
carry with respect to the obligations of each Party under this Agreement. If
replacement insurance (without any gap in coverage) meeting the requirements of
this Agreement is not obtained by the Party whose coverage is affected, then the
other Party shall have the right to terminate this Agreement upon thirty (30)
days prior written notice.
Section 8.7. LIMITATION ON REMEDY. EXCEPT AS PROVIDED IN SECTION 8.5
HEREOF, GTC'S EXCLUSIVE REMEDY AND GENZYME'S TOTAL LIABILITY TO GTC FOR CLAIMS
FOR BATCHES OF COLLABORATION PRODUCT DELIVERED UNDER THIS AGREEMENT THAT FAILS
TO MEET THE GTC MANUFACTURING SPECIFICATIONS AT THE TIME OF DELIVERY (EXCEPT AS
A DIRECT RESULT OF THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF GENZYME) IS
EXPRESSLY LIMITED AS FOLLOWS: GTC HAS THE OPTION OF REPLACEMENT OF, OR REPAYMENT
OF THE PRICE PAID FOR, THE BATCH OF COLLABORATION PRODUCT WITH RESPECT TO WHICH
FAILURES TO CONFORM ARE CLAIMED. GTC WAIVES ALL OTHER CLAIMS BY GTC AGAINST
GENZYME FOR SUCH BATCHES OF COLLABORATION PRODUCT DELIVERED UNDER THIS
AGREEMENT.
Section 8.8. GTC'S REPRESENTATIONS AND WARRANTIES. GTC hereby represents,
warrants and covenants to Genzyme that the milk to be provided to Genzyme by GTC
in connection with the Manufacturing Services shall meet the criteria mutually
agreed upon by the Parties and set forth in the Manufacturing Work Plan.
Section 8.9 GENZYME COVENANT. Genzyme hereby agrees that it will not use
any of the equipment that is owned by GTC and located in any Genzyme Facility or
otherwise on Genzyme's premises and listed on SCHEDULE VI hereto for any
products other than the Collaboration Products without compensating GTC for such
use at a commercially reasonable rate to be negotiated in good faith and
mutually agreed upon by the Parties that takes into account the amount, if any,
paid by Genzyme with respect to such equipment, including without limitation as
part of any purchase or acquisition cost or any depreciation expense of such
equipment.
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
- 18 -
ARTICLE 9. TERM AND TERMINATION
Section 9.1 TERM OF AGREEMENT. This Agreement shall be effective for a
period beginning on the Effective Date and ending upon the earlier of (i) the
date on which both the Manufacturing Services and RD&R Services have expired or
been terminated pursuant to this Article 9 or (ii) the third (3rd) anniversary
of the Effective Date, unless terminated as provided in Section 9.4 below. The
Parties agree to negotiate in good faith a reasonable extension of the term of
this Agreement for the purposes of extending the Manufacturing Services (but not
RD&R Services) if requested by either Party prior to the expiration of this
Agreement pursuant to the immediately preceding sentence.
Section 9.2 TERM AND TERMINATION OF MANUFACTURING SERVICES. Genzyme
shall provide Manufacturing Services hereunder until the earlier of (i) the
third (3rd) anniversary of the Effective Date, (ii) the date on which GTC first
receives marketing approval from a regulatory authority for the first
Collaboration Product, unless the Manufacturing Services are terminated earlier
pursuant to this Section 9.2, (iii) the expiration of the last mutually agreed
upon Manufacturing Work Plan or (iv) the successful completion of the transfer
of the Manufacturing Services to a third party and the delivery by Genzyme of
all of the deliverables agreed upon by the Parties in connection therewith
pursuant to Section 3.6 hereof. The Parties agree to negotiate in good faith an
extension of the three (3)-year period referenced in Section 9.2(i) above if
requested by either Party prior to the earlier of the expiration of said period.
The Parties may terminate the Manufacturing Services, with the remainder of this
Agreement remaining in full force and effect, as follows:
(a) GTC may terminate the Manufacturing Services at any time upon at
least one hundred and eighty (180) days prior written notice to Genzyme;
(b) Genzyme may terminate the Manufacturing Services upon at least one
hundred and eighty (180) days prior written notice to GTC, PROVIDED, HOWEVER,
that the effective date of any termination of the Manufacturing Services by
Genzyme pursuant to this clause (b) may not occur until the earlier of (A) the
date on which the transfer project contemplated by Section 3.6 hereto has been
successfully completed with respect to at least one Third Party vendor or (B)
the date on which GTC shall have provided Genzyme with written notice of the
completion of GTC's (or its Affiliate's) own manufacturing capacity; or
(c) the Parties may mutually agree in writing to terminate the
Manufacturing Services at any time.
Section 9.3. TERM AND TERMINATION OF RD&R SERVICES. Genzyme shall provide
RD&R Services hereunder until the earlier of (i) the date on which GTC or its
Affiliate or collaborative partner, as the case may be, first receives marking
approval from a regulatory authority for the first Collaboration Product, (ii)
such date as GTC withdraws application to receive marketing approval for the
first Collaboration Product, (iii) such date as a regulatory authority rejects
an application to receive marketing approval for the first Collaboration
Product, (iv) the date on which GTC notifies Genzyme that it or its Affiliate or
collaborative partner, as the case may be, has decided to stop development of
the Collaboration Products, (v) the third (3rd) anniversary of the Effective
Date or (vi) the expiration of the last mutually agreed xxxx XX&X Work Plan,
unless the RD&R Services are terminated earlier pursuant to this Section 9.3.
The Parties may terminate the RD&R Services, with the remainder of this
Agreement remaining in full force and effect, as follows:
(a) GTC may terminate the RD&R Services at any time upon ninety (90) days
prior written notice to Genzyme;
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(b) Genzyme may terminate the RD&R Services upon ninety (90) days prior
written notice to GTC, PROVIDED, HOWEVER, that the effective date of any
termination of the RD&R Services by Genzyme pursuant to this clause (b) may not
occur until Genzyme has delivered to GTC all of the RD&R Deliverables set forth
in the RD&R Work Plan;
(c) the Parties may mutually agree in writing to terminate the RD&R
Services at any time.
Section 9.4. TERMINATION OF THE AGREEMENT IN ITS ENTIRETY. The Parties
may terminate this Agreement in its entirety as provided below.
(a) FOR BREACH. Either Party may terminate this Agreement at any time if
the other Party breaches a material obligation under this Agreement and such
breach has not been remedied within sixty (60) days after the non-breaching
Party delivers written notice of such breach to the breaching Party.
(b) BANKRUPTCY. Either Party may terminate this Agreement in the event
that the other Party voluntarily or involuntarily enters a bankruptcy or similar
proceeding or passes a resolution for winding-up its business, or a court makes
an order to that effect (other than for the purpose of amalgamation or
reconstruction), or voluntarily or involuntarily has a receiver appointed in
respect of substantially all of its assets.
(c) MUTUAL AGREEMENT. The Parties may mutually agree in writing to
terminate this Agreement at any time.
(d) TERMINATION OF THE AMENDED COLLABORATION AGREEMENT. This Agreement
shall automatically terminate upon the termination for any reason of the Amended
Collaboration Agreement.
Section 9.5. EFFECTS OF TERMINATION; SURVIVAL.
(a) No termination of the Manufacturing Services, the RD&R Services or
this Agreement in its entirety pursuant to this Article 9 shall eliminate any
rights or duties of the Parties accrued prior to such termination.
(b) In the event of any termination of the Manufacturing Services
pursuant to Section 9.2 above or this Agreement in its entirety pursuant to
Section 9.4 above, GTC shall, as a condition precedent to the effectiveness of
such termination, (i) purchase any equipment identified in the Manufacturing
Work Plan from time to time that is acquired by Genzyme in connection with the
Manufacturing Services and is dedicated to, and not utilizable by Genzyme except
in the provision of, the Manufacturing Services, as expressly required by the
Manufacturing Work Plan, for a purchase price equal to the net book value of
such assets less any amounts paid by or charged to GTC, as depreciation,
original acquisition cost, or otherwise, (ii) pay to Genzyme termination charges
incurred by Genzyme from Third Party contractors and vendors related to the
Manufacturing Services and (iii) compensate Genzyme for any non-cancelable
obligations incurred by Genzyme in connection with the Manufacturing Services,
and (iv) purchase from Genzyme all of its inventory (intermediates, raw material
and finished product).
(c) In the event of any termination of the Manufacturing Services
pursuant to Section 9.2 above or this Agreement in its entirety pursuant to
Section 9.4 above, GTC and Genzyme shall negotiate in good faith for GTC to
sell, and Genzyme to purchase, any equipment owned by GTC located in any
Facility (or otherwise on Genzyme's premises) and listed on Schedule VI hereto
(i) that GTC does not desire to use, retain or transfer to its Third Party
vendor and (ii) for which Genzyme determines that it has
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a reasonable alternative use and need, at a price equal to (A) the [*****] of
such equipment [*****] (B) the [*****] with respect to such equipment,
including, without limitation, as part of any purchase or acquisition cost, or
any depreciation expense of such equipment.
(d) In the event of any termination of the Manufacturing Services
pursuant to Section 9.2 above or of this Agreement in its entirety pursuant to
Section 9.4 above, on or prior to the date twenty (20) Business Days after the
effective date of such termination, or as otherwise agreed in writing by the
Parties, Genzyme shall deliver to GTC all property of GTC located at any
Facility (or otherwise on Genzyme's premises) or facility of any contractor of
Genzyme other than such equipment that is subject to Section 9.5(c) above. Such
delivery shall be made in accordance with the written instructions of GTC, which
written instructions shall be provided to Genzyme at least fifteen (15) Business
Days prior to the termination date. All delivery and related expenses accruing
from the time such property is delivered to such common carrier shall be borne
by GTC, except in the case of a termination of this Agreement by GTC under
Section 9.4(a) above, in which case Genzyme shall bear such delivery costs.
(e) In the event of any termination of the RD&R Services pursuant to
Section 9.3 above or of this Agreement in its entirety pursuant to Section 9.4
above, on or prior to the date twenty (20) Business Days after the effective
date of the termination of the RD&R Services, or as otherwise agreed in writing
by the Parties, Genzyme shall deliver to GTC all property of GTC located on
Genzyme's premises or the premises of any contractor of Genzyme, including,
without limitation, all RD&R Deliverables to be delivered prior to the effective
date of termination pursuant to the RD&R Work Plan, whether such deliverables
are complete or at any stage of work-in-progress (including, without limitation,
any preparatory materials related thereto). Such delivery shall be made in
accordance with the written instructions of GTC, which written instructions
shall be provided to Genzyme within fifteen (15) Business Days prior to the
termination date. All delivery and related expenses accruing from the time such
property is delivered to such common carrier shall be borne by GTC, except in
the case of a termination of this Agreement by GTC under Section 9.4(a) above,
in which case Genzyme shall bear such delivery costs.
(f) The provisions of Articles 1 and 7 and Sections 2.2 (unless and until
such time as the Amended Collaboration Agreement is terminated), 3.4, 4.2(a)
through (c) (inclusive), 5.4, 6.4, 8.1, 8.3, 8.5, 9.5, 10.1, 10.5 through 10.7
(inclusive) and 10.9 hereof shall survive the expiration or earlier termination
of this Agreement.
ARTICLE 10. MISCELLANEOUS
Section 10.1. NON-SOLICITATION. During the term of this Agreement and for
a period of one (1) year thereafter, neither Party or its Affiliate shall
solicit the employment of any person who, during the term of this Agreement,
shall have been an employee of the other Party; PROVIDED, HOWEVER, that general
advertising not specifically directed to such other Party's employees shall not
be deemed to constitute solicitation under this Section.
Section 10.2. 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, including without limitation to
contamination or diseases affecting the herd of Transgenic Animals from which
ATIII is produced; PROVIDED, HOWEVER, that the Party so affected shall use
commercially reasonable efforts to avoid or remove such causes of
non-performance, and shall
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
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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 10.3. ASSIGNMENT. This Agreement may not be assigned or otherwise
transferred by any Party without the consent of the other Party (which consent
shall not be unreasonably withheld or delayed); PROVIDED, HOWEVER, that either
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. Any permitted
assignee shall assume all obligations of its assignor under this Agreement. Any
purported assignment in violation of this Section 10.3 shall be void.
Section 10.4. 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 10.5. NOTICES. Any consent, notice or report required or permitted
to be given or made under this Agreement by one Party to the 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 10.5 and shall be
effective upon receipt by the addressee
If to GTC:
Genzyme Transgenics Corporation
000 Xxxxxxxx Xxxxxxxxx
Xxxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: President
Facsimile: (000) 000-0000
with a copy to:
Genzyme Transgenics Corporation
000 Xxxxxxxx Xxxxxxxxx
Xxxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: General Counsel
Facsimile: (000) 000-0000.
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If to Genzyme: Genzyme Corporation
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: President and Chief Executive Officer
Facsimile: (000) 000-0000
with a copy to: Genzyme Corporation
Xxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Legal Officer
Facsimile: (000) 000-0000.
Section 10.6. 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 10.7. DISPUTES.
(a) Any disputes arising among or between the Parties 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
resolved in accordance with the following provisions.
(i) The representatives of the Parties (which, in the case of any
dispute between GTC and Genzyme in connection with Article 3 or 4 hereof, shall
be each such Party's Project Coordinator for the purposes of such Article) 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 10.7 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 days after the date
it is postmarked. In addition, each Party(ies) party to such dispute may take up
to three 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 arbitrator shall not have the power to order the answering
of interrogatories or the response to requests for admission. In
- 23 -
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 10.7 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 10.7 shall be enforceable in any court of competent
jurisdiction.
Section 10.8. ENTIRE AGREEMENT: AMENDMENT. This Agreement, together
with the Purchase Agreement and the Amended Collaboration Agreement and the
schedules and exhibits hereto and thereto, contains the entire understanding
of the Parties with respect to the subject matter hereof. All express or
implied agreements and understandings, either oral or written, heretofore
made are expressly merged in and made a part of this Agreement, including
without limitation 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 Genzyme, GTC and ATIII LLC, as amended to date; PROVIDED, HOWEVER, that
this Agreement shall not affect the rights and obligations of Genzyme, GTC
and ATIII LLC, a Delaware limited liability company, under the [*****]
Agreement dated as of [*****] among Genzyme [*****], GTC and ATIII LLC
related [*****] which shall remain in full force and effect. 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 10.9. 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 10.10. 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 10.11. 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 waiver of
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
- 24 -
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 10.12. 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]
- 25 -
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/ Xxxx X. Xxxxx
Name: Xxxx X. Xxxxx
Title: Vice Present
- 26 -
Schedule I
INITIAL MANUFACTURING WORK PLAN
See Attached.
- 27 -
SCHEDULE I
MANUFACTURING SERVICES WORK PLAN
Manufacturing Services Work Plan Confidential X. Xxxxxx
TABLE OF CONTENTS
1. GOALS AND OBJECTIVES
2. SCOPE OF SERVICES
3. PROCESS DESCRIPTION
11/09/01 2
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
- 28 -
Schedule II
TRANSFER PROJECT DELIVERABLES
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
- 29 -
Schedule III
INITIAL RD&R WORK PLAN
See Attached.
- 30 -
RESEARCH, DEVELOPMENT AND REGULATORY
(RD&R) SERVICES WORK PLAN
17 July 2001
- 31 -
Table of Contents
1. Goals and Objectives
2. Scope of Services
3. Additional Provisions for RD&R Services
4. Budget (see attachments)
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
3. ADDITIONAL PROVISIONS FOR RD&R SERVICES
IND SPONSORSHIP. Genzyme shall transfer no later than September 1, 2001 all
sponsor obligations for any existing Investigational New Drug applications
("INDs") related to the Collaboration Products to GTC (or ATIII LLC if so
instructed in writing by GTC) as of Effective Date, and GTC shall, itself or
through ATIII LLC, maintain all such IND sponsor obligations throughout the term
of this Agreement.
REGISTRATION APPROVAL. GTC shall be responsible for seeking, obtaining and
maintaining all Regulatory Approvals and all approvals from the Regulatory
Authorities regarding marketing and advertising materials. Genzyme shall
cooperate with GTC in making and maintaining all filings that may be necessary
or desirable in accordance with the RD&R Work Plan. Prior to any submission to
the FDA or any authority under the applicable Regulatory Scheme, or with respect
to any Regulatory Approval, the technical managers of Genzyme and GTC shall
consult on the content and scope of such Regulatory Approval filings. Genzyme
shall fully cooperate with GTC in its efforts to obtain regulatory approvals and
shall provide such assistance as may be necessary for GTC to fully satisfy its
obligations, including the collection of Collaboration Product related
information and the preparation of reports with respect to such information. The
scope and details of such cooperation by Genzyme shall be mutually agreed upon
in writing by the GTC and Genzyme Regulatory Affairs departments. GTC shall
apply for the Registration Approval as agreed, subject to the following
conditions:
ADVERTISING AND PROMOTIONAL MATERIALS. Marketing and promotional materials
related to the Collaboration Product shall not reference Genzyme without prior
written approval of Genzyme in accordance with its written procedures.
COMMUNICATION WITH AGENCIES. GTC shall have responsibility for communications
with the Regulatory Authorities concerning the Registration Approval and
approval of Collaboration Product related to marketing and advertising
materials. Each party shall advise the other party of material developments and
events relating to their respective regulatory responsibilities in writing
within two (2) Business Days after notice of such material development and
events.
ADVERSE EVENTS. As of the Effective Date and throughout the term of this
Agreement, GTC shall be responsible for notification of Regulatory Authorities
of any death, life-threatening event, unexpected adverse experience, or an event
that could result in permanent injury or impairment or prolonged
hospitalization, whether or not related to the Collaboration Product (an
"Serious Adverse Event"). If at any time either party receives notice of a
Serious Adverse Event (the "Notifying Party"), the Notifying Party shall notify
the other party (the "Notified Party") in a timely manner (but not later than
two (2) days) by telephone, confirmed in writing, to the person designated as
the Notified Party's contact for such purposes. The Serious Adverse Event
information shall be classified and maintained by GTC in accordance with the
Medical Dictionary for Regulatory Activities standard, as amended from time to
time. The SOP shall include, without limitation, the foregoing relating to
notification of Serious Adverse Events and maintenance of such information. GTC
shall have responsibility to determine whether such information must be reported
to the FDA (under United States law) or the Regulatory Authorities. GTC shall
make an initial determination as to reportability, and shall communicate such
information to Genzyme (to the attention of the Technical Director) within an
additional three (3) Business Days. In addition to the foregoing, the parties
shall develop mutually acceptable guidelines and procedures to govern the
sharing of adverse experience information, and the assessment and submission of
adverse experience reported to the FDA and the Regulatory Authorities within
thirty (30) days after the Approval Date.
COMPLAINTS AND INQUIRIES AS TO SAFETY, QUALITY, OR EFFICACY. As of the Effective
Date and throughout the term of this Agreement, GTC shall be responsible for
handling the treatment of complaints and inquiries as to the safety, quality or
efficacy of the Collaboration Product. GTC shall collect and investigate such
complaints or inquiries, and shall within two (2) Business Days of GTC's receipt
of such complaint or inquiry, forward all complaints and inquiries to Genzyme.
Genzyme shall respond to all complaints and inquiries relating to the
Collaboration Product in a timely manner. If an investigation by Genzyme is
needed in response to a complaint or inquiry, Genzyme shall conduct such an
investigation and will forward the results thereof to GTC within a reasonable
time. GTC shall retain records of all Collaboration Product related complaints,
inquiries or Adverse Events for a period of not less than three (3) years beyond
the termination date of this Agreement or for such longer period as may be
required by applicable law.
REPORTING AND POST MARKETING SURVEILLANCE. GTC shall have the responsibility of
preparing and filing all required regulatory reports and updates and for
conducting Post Marketing Surveillance ("PMS") for the Collaboration Products.
Genzyme shall fully cooperate with GTC in its efforts to file regulatory reports
and updates and shall provide such assistance as may be necessary for GTC to
fully satisfy its obligations, including the collection of Collaboration Product
related information and the preparation of reports with respect to such
information. The scope and details of such cooperation by Genzyme shall be
mutually agreed upon in writing by the GTC and Genzyme Regulatory Affairs
department.
COLLABORATION PRODUCT RECALLS. As of the Effective Date and throughout the term
of this Agreement, GTC shall prepare and maintain a written SOP to handle any
recalls of the Collaboration Product. Such SOP shall include, without
limitation, prior notice to and approval by Genzyme of any recall. In the event
that (i) any governmental agency or authority issues a request or directive or
orders that the Collaboration Product be recalled or retrieved, (ii) a court of
competent jurisdiction orders that the Collaboration Product be recalled or
retrieved, or (iii) Genzyme and GTC reasonably determine, after mutual
consultation, that the Collaboration Product should be recalled, retrieved or a
"Dear Doctor" letter is required relating to restrictions on use of the
Collaboration Product, GTC shall conduct such activity and the parties shall
take all appropriate corrective actions and shall execute the steps detailed in
the SOP. In the event such action results from Genzyme's negligence or willful
misconduct, Genzyme shall be responsible for the expenses thereof. In the event
such action results from GTC's negligence or willful misconduct, GTC shall be
responsible for the expenses thereof. For purposes of this Agreement, the
expenses of the action shall be the expenses of notification and return or
destruction (if authorized by Genzyme) of units of the Collaboration Product,
the cost of replacement of the Collaboration Product, and any costs directly
associated with the distribution or replacement Collaboration Product.
Otherwise, the parties shall share equally the expenses of the action. GTC and
Genzyme shall cooperate fully with one another in conducting any such action.
TECHNICAL DIRECTOR. Within ten (10) days after the Effective Date, GTC shall
identify to Genzyme a candidate to serve as the technical director for all
regulatory matters relating to the Collaboration Product (the "Technical
Director"). The Technical Director shall coordinate and direct all of the
activities undertaken by GTC to achieve the Registration Approval and all other
Regulatory Authority approvals related to the Collaboration Product. The
Technical Director shall serve as the point of contact with the Regulatory
Authorities, and shall be responsible for submitting all reports and documents
as may be required by the Regulatory Authorities with respect to the
Collaboration Product, including without limitation, notices regarding Adverse
Events. In the event that GTC appoints a new Technical Director, Genzyme shall
be notified within thirty (30) days of the appointment.
RECORDS. Unless otherwise stated in this Article, Genzyme shall create and
maintain records of all duties
performed under this Article and shall retain such records for the duration of
this Agreement. Upon termination of this Agreement, Genzyme shall forward copies
of all records to GTC within thirty (30) Business Days.
4. BUDGETS
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Schedule IV
INITIAL PROJECT MANAGERS
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Schedule V
FORM OF INVOICE
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
SCHEDULE VI
GTC EQUIPMENT LOCATED IN GENZYME FACILITIES
[*****]
------------------------
Confidential materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
