EXHIBIT 10.6
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (together with the
attached Schedules, the "Agreement") is made as of this 25th day of September,
1997 (the "Effective Date") by and between Genzyme Transgenics Corporation, a
Massachusetts corporation having a principal place of business at Xxxx Xxxxxxxx
Xxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx 00000-0000 ("GTC") and X. Xxxxx Melsungen AG, a
German corporation having a principal place of business at Xxxx-Xxxxx-Xxxx x 0,
X-00000 Xxxxxxxxx, Xxxxxxx ("X. Xxxxx").
1. Background.
1.1. GTC. GTC is a biopharmaceutical company with experience in the
production of recombinant human proteins in the milk of goats through
the application of transgenic technology. GTC has the rights to make,
use and sell transgenically-produced recombinant human [*] ("rh[*],"
more fully defined below).
1.2. X. Xxxxx. X. Xxxxx is engaged in the development, manufacture and
sale of pharmaceutical and other products, and is interested in the
sale and distribution in the Territory (defined below) of Products
(defined below) which are filled and finished by X. Xxxxx from the
rh[*] supplied to it by GTC under this Agreement.
2. Definitions.
2.1. "Acceptance Assays" means (a) the assays which are included in GTC's
BLA for Bulk rh[*], to be listed as part of the Specifications on
Schedule A to this Agreement, the procedures for the performance of
which will be transferred to X. Xxxxx by GTC on a schedule to be
agreed upon by the parties, and (b) such other or additional assays
which X. Xxxxx and/or GTC is required by the applicable Regulatory
Authorities to perform for production and/or import of the Bulk rh[*]
(or any Product properly filled and finished therefrom) into the
Territory for distribution, sale and use.
2.2. "Affiliate" means an individual, trust, business trust, joint venture,
partnership, subsidiary, corporation, association or any other entity
which (directly or indirectly) is controlled by, controls or is under
common control with a Party. For the purposes of this definition, the
term "control" (including, with correlative meanings, the terms
"controlled by" and "under common control with") as used with respect
to any Party, shall mean the possession (directly or indirectly) of at
least forty percent (40%) of the outstanding voting securities of a
corporation or comparable equity interest in any other type of entity,
or the power to control or direct management even in the absence of a
controlling interest.
2.3. "BLA" means a United States biologics license application or its
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equivalent.
2.4. "Bulk rh[*]" means transgenically-produced rh[*] supplied to X. Xxxxx
by GTC under this Agreement.
2.5. "Certificate of Analysis" means a duly authorized, signed and dated
document accompanying each shipment of Bulk rh[*] from GTC under this
Agreement which is intended for administration to humans, certifying
that the Bulk rh[*], identified by batch number, meets the
Specifications, and that the Transgenic Goats, production processes,
equipment, materials, facilities and procedures associated with the
production of such Bulk rh[*] conform to GMP guidelines and all
applicable regulatory filings.
2.6. "Confidential Information" means all proprietary information and
materials, patentable or otherwise, including DNA sequences, vectors,
cells, substances, formulations, techniques, methodology, equipment,
data, reports, know-how, sources of supply, patent positioning and
business plans, including any negative developments, which are
communicated to, learned of, developed or otherwise acquired by GTC or
X. Xxxxx, and any other information designated by the disclosing party
as confidential or proprietary, whether or not related to the Bulk
rh[*] or Product. As used in this Agreement, the term "Confidential
Information" shall be interpreted consistent with the exceptions set
forth in Section 15.2, below.
2.7. "Cost of Goods Sold" means, with respect to the manufacture of a
Product, all direct and indirect labor and overhead, tangible
materials and supplies, fringe benefits, taxes and charges and direct
and indirect general and administration charges incurred by X. Xxxxx
related to the manufacture and sale of the Product, and accounted for
according to X. Xxxxx'x standard accounting practices consistent with
generally accepted accounting principles.
2.8. "CPMP" means the Committee for Proprietary Medicinal Products.
2.9. "Direct Cost" means (a) costs directly attributable to an activity
(i.e., those costs which vary with such activity), including, but not
limited to, direct labor and benefit expenses for such activity, and
consumable bulk and other materials, as determined in accordance with
generally accepted cost accounting practices in the country of the
activity, plus (b) fixed overhead costs allocable to the activity,
including, but not limited to, direct benefit and labor expenses for
technical services and support services, depreciation, maintenance and
repairs and insurance costs associated with such activity, as
determined in accordance with generally accepted cost accounting
practices in the country of the activity.
2.10."EMEA" means the European Medicines Evaluation Agency.
2.11."Field" means the use of rh[*] for medicinal purposes, including,
without limitation, [*].
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2.12. "Founder Goat(s)" means a Transgenic Goat from which a Production
Herd can be produced using standard animal husbandry techniques.
2.13. "GMP" means the Good Manufacturing Practice regulations of the
FDA as described in the United States Code of Federal Regulations
or any successor regulations and any similar or equivalent
regulations in the European Community or Japan.
2.14. "GTC Patent Rights" means any and all patents and patent
applications owned or licensed by GTC in which GTC has a
licensable interest and which exists as of the date of this
Agreement or which comes into existence during the term of this
Agreement, including, without limitation, the patents and patent
applications attached to this Agreement as Schedule B; provided,
however, such patents and patent applications, if developed by
GTC during the term of this Agreement, shall be deemed solely to
be Project Patent Rights as defined in Section 2.24, below,
unless GTC can reasonably demonstrate that such patents or patent
applications were independently developed by GTC outside of the
scope of this Agreement.
GTC Patent Rights shall include any reissues, extensions (or other
governmental acts which effectively extend the period of
exclusivity by the patent holder), substitutions, confirmations,
registrations, revalidations, additions, continuations,
continuations-in-part, divisions or foreign counterparts of or to
the foregoing patent rights.
2.15. "GTC Technology" means information, data, trade secrets,
processes, inventions, improvements and know-how which is owned
or controlled by GTC and in which GTC has a licensable interest,
and which exists as of the date of this Agreement or which comes
into existence during the term of this Agreement, related to the
transgenic production of rh[*], provided, however, such
technology, if developed by GTC during the term of this
Agreement, shall be deemed solely to be Project Technology as
defined in Section 2.25, below, unless GTC can reasonably
demonstrate that such technology was independently developed by
GTC outside of the scope of this Agreement.
2.16. "rh[*]" means the recombinant human [*] produced by Transgenic
Goats in the Production Herd pursuant to the terms and conditions
of this Agreement and in accordance with the protocols and
specifications established herein.
2.17. "IND" means an Investigational New Drug application or its
equivalent for initiating clinical trials in the United States or
any corresponding foreign application, registration, or
certification.
2.18. "Koseisho" means the Japanese Ministry of Health.
2.19. "Net Sales Price" means the gross billing price derived by or
payable to X. Xxxxx and its Affiliates and permitted sublicensees
from or on account of the sale
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of Product to third parties which are not Affiliates of X. Xxxxx,
less: (a) customary trade, quantity or cash discounts or rebates
allowed; (b) amounts rebated, refunded or credited for rejected
or returned Products or because of retroactive price reductions,
rebates or chargebacks; (c) customs duties, consular fees and
other like charges; (d) sales, use, turnover, excise taxes, or
other governmental charges levied on or measured by sales, but not
franchise or income taxes; (e) uncollected accounts receivable
attributable to sales of Products; and (f) transportation,
freight and handling charges, and insurance on shipments to
customers. Transfer of a Product by X. Xxxxx to an Affiliate
shall not be considered a sale.
In the event any Product is sold as a component of a combination
of functional elements, Net Sales Price for purposes of
determining royalty payments on such combination shall be
calculated on a country-by-country basis by multiplying the
average per unit Net Sales Price of the Product portion of the
combination when sold separately in the applicable country during
the accounting period in which the sale was made by the number of
units of Product sold as part of such combination product. In the
event no separate sales of the Product were made in the applicable
country during the applicable accounting period, the Net Sales
Price of such Product shall be determined by the Liaison
Committee.
2.20. "Parties" means GTC and X. Xxxxx; "Party" means GTC or X. Xxxxx.
2.21. "Product" means a product consisting of rh[*]-solution(s) and/or
rh[*]-powder (bulk) as a component meeting the Specifications
established by Schedule A.
2.22. "Purchase Price" means the prices per gram for Bulk rh[*] sold by
GTC to X. Xxxxx, as provided in Section 7.2, below.
2.23. "Production Herd" means a line of female Transgenic Goats derived
from a Founder Goat.
2.24. "Project Patent Rights" means (a) all patent applications
established by one or both of the Parties in performance of this
Agreement and hereafter filed or having legal force in any
country, which claim a composition, method or process relating to
Project Technology, together with any and all patents that have
issued or in the future issue therefrom, and (b) all related
divisionals, continuations, continuations-in-part, reissues,
renewals, extensions or additions to any such patents and patent
applications.
2.25. "Project Technology" means information, data, trade secrets,
processes, inventions, improvements and know-how established by
one or both of the Parties in performance of this Agreement.
2.26. "Regulatory Authority" shall mean the United States Food and Drug
Administration (the "FDA") and similar government agencies
throughout the world, including, without limitation, the EMEA
and/or the CPMP, which regulate
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the manufacture and marketing of Bulk rh[*] and/or the Product
in Europe, and the Koseisho, which regulates the manufacture
and marketing of Bulk rh[*] and/or the Product in Japan.
2.27. "SOP" has the meaning assigned to it in Section 4.2.
2.28. "Specifications" means the specifications and test methods for
Bulk rh[*] sold by GTC to X. Xxxxx, to be set forth in Schedule A
to this Agreement, which Schedule may be amended from time to
time only by written agreement of the Parties. The
Specifications shall meet the requirements (including, without
limitation, stability and release testing requirements) of each
applicable Regulatory Authorities for import of the Bulk rh[*]
(or any Product properly filled and finished therefrom) into the
applicable country or countries in the Territory for
distribution, sale and use.
2.29. "Territory" means [*]. In the event X. Xxxxx exercises its
Co-Marketing Option set forth in Section 8.1, below, the
Territory shall include [*], on a co-exclusive basis.
2.30. "Transgenic Goat" means a goat whose genome has been modified by
the incorporation of exogenous DNA, including, but not limited
to, DNA encoding rh[*], and which meets the Specifications set
forth in Schedule A.
2.31. "Pivotal Clinical Trial " meansthe final clinical trial which is
deemed necessary by the applicable Regulatory Authority in a
country in the Territory to support the filing of a BLA for
approval to market and sell the Product in such country.
2.32. Singular/Plural. The singular shall include the plural and the
plural the singular for the terms defined in this Section 2.
3. Liaison Committee. Within thirty (30) days of the Effective Date, GTC and
X. Xxxxx shall form a committee (the "Liaison Committee") to coordinate and
communicate the results of the Parties' activities under this Agreement.
The Liaison Committee shall consist of four (4) members, two (2) of whom
shall be designated by GTC and two (2) of whom shall be designated by X.
Xxxxx. Each Party may assign its members to the Liaison Committee as it
deems appropriate, and designated substitutes may represent Liaiso
Committee members at regularly scheduled meetings at the discretion of the
substituting Party. The Liaison Committee will meet at least once per
calendar quarter, alternating between GTC and X. Xxxxx locations, to assess
the progress under this Agreement. In addition to reports to, and meetings
of, the Liaison Committee, there will be frequent communications among the
scientists and project managers to keep X. Xxxxx and GTC advised of current
activities, research, testing and achieved results of the Parties under
this Agreement.
4. Development and Manufacture of Bulk rh[*].
4.1. Agreement to Develop and Manufacture. GTC agrees to use commercially
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reasonable and diligent efforts to (a) develop a Production Herd of
Transgenic Goats to produce rh[*] in their milk, (b) meet the
milestones and perform the activities set forth in Section 4.7 and, if
X. Xxxxx exercises its co-marketing option under Section 8.1, below,
in Section 8.3 of this Agreement, and undertake the activities shown
in Schedule C to this Agreement, and (c) supply X. Xxxxx with its
requirements of Bulk rh[*], on the terms and conditions set forth in
this Agreement. Schedule C to this Agreement sets forth a schematic
estimated timeline of GTC's development plan. In the event of any
conflict between the text of this Agreement and the schematic
timeline, the text of this Agreement shall control. In performing
their obligations under this Agreement, the Parties shall keep each
other informed, via the Liaison Committee, of Project Patent Rights
and Project Technology developed during the term of this Agreement.
4.2. Good Agricultural Practices. GTC shall use Good Agricultural
Practices ("GAP") in the development of Transgenic Goats pursuant to
this Agreement. GAP shall be defined as a series of standard
operating procedures ("SOPs") covering recovery of fertilized eggs,
pronuclear microinjection, embryo transfer, pregnancy, delivery,
rearing and milking of the Transgenic Goats.
4.3. In Accordance with Specifications. All Bulk rh[*] ordered by X. Xxxxx
under this Agreement shall conform to Specifications. With respect to
the countries in the Territory, GTC shall be responsible for ensuring
that the Specifications comply with any licenses and approvals
including, without limitation, the licenses and approvals necessary to
export the Bulk rh[*] and any outright Product in such countries on a
country-by country basis, including all then-current licenses and
approvals granted or issued to GTC by the relevant Regulatory
Authorities.
4.4. Establishment of and Changes to Specifications. As set forth in
Section 2.28, the Specifications may be modified from time to time
only by written agreement of the Parties. X. Xxxxx shall not propose
to any Regulatory Authority the establishment of any Specification, or
any changes to the Specifications, or in any methods for testing the
Bulk rh[*] and/or the Product to assess conformity thereof with the
Specifications (e.g., the Acceptance Assays), without GTC's prior
written consent, which consent shall not be unreasonably withheld.
GTC shall have the right to consult in advance with X. Xxxxx for, and
to participate with X. Xxxxx in, any such discussions with Regulatory
Authorities which could lead to the establishment of any
Specifications, or any required or recommended changes in the
Specifications or associated testing methods.
4.5. Quality Control and Analysis.
a. GMP Compliance. All Bulk rh[*] supplied by GTC shall meet the
GMP guidelines required by the applicable Regulatory Authorities
and shall meet the Specifications, on a country-by country basis,
and such other specifications as are mutually agreed upon by GTC
and X. Xxxxx. The facilities and Transgenic Goats utilized by
GTC to make Bulk rh[*] shall comply with the Regulatory Authority
license requirements. GTC shall
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maintain such records and data as are necessary to ensure that
the manufacture of such Bulk rh[*] can be demonstrated to comply
with such guidelines and requirements. GTC agrees to furnish to
X. Xxxxx certification in such form as is required by the
applicable Regulatory Authorities and other governmental agencies
with proper jurisdiction that the manufacture of such Bulk rh[*]
complies with such guidelines and requirements.
b. Release Testing. GTC shall be solely responsible for performing
stability and release testing for the Bulk rh[*] available for
purchase by X. Xxxxx. As part of its fill/finish activities
under this Agreement, X. Xxxxx shall be solely responsible for
stability and release testing of all final Product available for
distribution and/or sale by X. Xxxxx.
c. Documentation and Inspections.
i. Documents. GTC shall provide X. Xxxxx with copies of any
records, documentation and technical assistance which may be
reasonably required for X. Xxxxx or any of its Affiliates or
Sublicensees of the Product to obtain from the appropriate
Regulatory Authorities approval to import and use the Bulk
rh[*], based on GTC's manufacture of such Bulk rh[*]. X.
Xxxxx shall provide GTC with copies of all documentation
pertaining to Bulk rh[*] and/or the Product prior to
submission of such documentation to the applicable
Regulatory Authorities. Each Party shall promptly review
such documentation and provide the other Party with any
comments it may have concerning such documentation and/or
the form in which any such information is delivered to such
Regulatory Authorities.
ii. Right to Inspect. X. Xxxxx, at its own expense, shall have
the right, from time to time, to send its technical and
quality personnel to GTC's manufacturing facilities to
inspect and audit the manufacturing and storage facilities
allotted to the Bulk rh[*] and to inspect and audit the
records (except for financial records) and documentation
related to the Bulk rh[*]. Upon prior notice to GTC, all
such personnel and representatives shall be freely admitted
by GTC for such purposes during reasonable and regular
business hours. All such personnel shall be required to
sign usual and customary confidentiality agreements and to
follow GTC's safety rules and procedures in effect at the
production facility.
4.6. Subcontracting. GTC's obligations under this Agreement may be
delegated to and fulfilled by Affiliate and/or non-Affiliate
subcontractors (i.e., by third party designees); provided, however,
(a) X. Xxxxx shall have the right to consent to such subcontractors,
(b) such subcontracting shall be on terms and conditions fully
consistent with the terms and conditions of this Agreement and (c) GTC
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shall remain fully responsible for the performance of all of its
obligations under this Agreement, notwithstanding any such
subcontracting.
4.7. Development Compensation. In accordance with the following schedule,
X. Xxxxx shall pay GTC the following payments in consideration of
GTC's development of rh[*]:
Estimated
Milestone Completion Date
a. Base Fee. [*] within [*].
b. [*] within [*]. The successful transgenic
identification of the Transgenic Goats will be
determined by polymerase chain reaction ("PCR")
of goat blood and ear biopsy. Transgenic
identification will be confirmed and
characterized by Southern blotting.
c. [*].
d. [*]. GTC shall update this commercial report
at each separate stage/milestone under this
Agreement.
e. [*].
f. [*]. The Liaison Committee shall consider
using XxXxx, Inc. of Irvine, California as
the contract research organization for the
performance of such preclinical studies.
g. [*].
h. [*]. The clinical plan for such trial shall
be developed in consultation with the Liaison
Committee.
i. [*].
[*]. The estimated completion date for the milestones set
forth above refer to the last day of the specified month.
[*].
4.8. Payments. All payments to GTC under this Agreement
will be made in U.S. Dollars by wire transfer of good
and immediately available funds to GTC's bank account
at [*], or by any other means agreed upon by the
Parties. Payments
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made to GTC under this Section 4 shall be made in United States
Dollars without regard to changes in exchange rates.
4.9. Capital, Facilities and Personnel. To the extent commercially
reasonable, GTC shall at all times possess sufficient capital,
facilities (directly or through third parties)(including warehouse
facilities) and administrative personnel to support GTC's obligations
under this Agreement.
4.10. Inventory. GTC shall maintain a sufficient inventory of Bulk
rh[*] and/or components thereof to provide delivery of Bulk rh[*]
to X. Xxxxx under the terms and conditions of this Agreement.
5. Purchase and Supply Terms and Conditions. X. Xxxxx agrees to purchase all
of its requirements of Bulk rh[*] from GTC, and GTC agrees to supply X.
Xxxxx with such requirements, on the terms and conditions set forth in this
Agreement. The obligations of the Parties with respect to projections,
forecasts and purchase orders are set forth in Sections 5.1 through 5.5,
below.
5.1. Initial Five Year Sales Projection and Updates. Promptly following
the Effective Date, X. Xxxxx will provide GTC with an initial
projection of the amount of Product X. Xxxxx expects to sell during
[*] (or such other launch date as specified by the Liaison Committee)
and each of the next four (4) successive calendar years, subject to
applicable Regulatory Authority approvals in the Territory.
Thereafter, on or before January 1st in each year, X. Xxxxx will
provide GTC with an updated projection of the amount of Product X.
Xxxxx expects to sell during the subsequent calendar year and each of
the next four (4) successive calendar years. Such projections shall
be used by GTC for planning purposes only and shall not create binding
sales or purchase obligations for either Party hereto. GTC and X.
Xxxxx will meet periodically to review X. Xxxxx'x projected
requirements for Bulk rh[*].
5.2. Initial Four Quarter Forecast. Within fifteen (15) business days of
the date GTC or X. Xxxxx notifies the other Party that it (or its
Affiliate or third party designee) has completed a Pivotal Clinical
Trial of rh[*], X. Xxxxx will provide GTC with an initial, non-binding
four-quarter forecast of the amount of Bulk rh[*] X. Xxxxx expects to
purchase from GTC during the four (4) calendar quarters commencing
nine (9) months following completion of such Pivotal Clinical Trial.
5.3. First Purchase Order and Updated Forecast. At a time to be determined
by X. Xxxxx, X. Xxxxx will provide GTC with:
a. First Purchase Order. A first purchase order specifying the
amount of Bulk rh[*] to be delivered to X. Xxxxx nine (9) months
after such purchase order; and
b. Updated Four-Quarter Forecast. An updated four-quarter forecast
of
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the amount of Bulk rh[*] X. Xxxxx expects to purchase from GTC
during each of the second, third and fourth calendar quarters
covered by, and the next calendar quarter following, the
preceding four-quarter forecast.
5.4. Subsequent Purchase Orders and Updated Forecasts. On or before the
first day of each subsequent calendar quarter, X. Xxxxx will provide
GTC with:
a. Quarterly Purchase Orders. A purchase order specifying the
amount of Bulk rh[*] to be delivered to X. Xxxxx during the
calendar quarter which begins nine (9) months from the date of
such purchase order; and
b. Updated Four-Quarter Forecasts. An updated four-quarter forecast
of the amount of Bulk rh[*] X. Xxxxx expects to purchase from GTC
during each of the second, third and fourth calendar quarters
covered by, and the next calendar quarter following, the
preceding four-quarter forecast.
5.5. Good Faith Projecting and Forecasting. In preparing the projections
and forecasts, X. Xxxxx shall use commercially reasonable and diligent
efforts to accurately predict its Product sales and actual
requirements for Bulk rh[*].
5.6. Minimum Purchase and Maximum Supply Commitments. For each calendar
quarter commencing six (6) months following filing by GTC or X. Xxxxx
(or their respective Affiliates or third party designees) of a BLA
for rh[*], X. Xxxxx shall be obligated to purchase at least eighty
percent (80%) of the amount of Bulk rh[*] forecasted for such quarter
in the most recent four-quarter forecast, subject to ongoing
Regulatory Authority approval (and any other necessary approvals) to
sell Products; and GTC shall be obligated to supply up to, but not
more than, one hundred twenty percent (120%) of the amount forecasted
for such quarter in the most recent four-quarter forecast. X. Xxxxx'x
minimum purchase obligations under this Section shall be reduced
adequately in the event that a Regulatory Authority in a country in
the Territory has prohibited X. Xxxxx from selling Product in such
country.
5.7. Purchase Orders.
a. Submission by X. Xxxxx. All orders for Bulk rh[*] by X. Xxxxx
shall be made by submission to GTC of a purchase order specifying
the quantity of Bulk rh[*] ordered and the requested delivery
date(s), and shall be consistent with the terms of this
Agreement.
b. Acceptance by GTC. Subject to the terms and conditions of this
Agreement, GTC shall be required to accept purchase orders which
conform to the limitations and requirements of Section 5.6 of
this Agreement. GTC shall notify X. Xxxxx within ten (10)
working days of receipt regarding the acceptance or permitted
rejection of a purchase order.
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c. Order Lead Time. A nine (9) month period is required from the
date GTC receives an accepted purchase order to the availability
of Bulk rh[*] for delivery under such purchase order to allow for
scheduling, preparation and testing of the Bulk rh[*] for
delivery to X. Xxxxx. This order lead time is required for all
purchase orders, no matter what their magnitude.
5.8. Delivery. GTC shall deliver Bulk rh[*] to X. Xxxxx or its designated
carrier at the times and in the amounts specified in each accepted
purchase order, provided that the lead times and quantities specified
in the purchase order conform with this Agreement.
5.9. Documentation. Each shipment of Bulk rh[*] shall be accompanied by a
Certificate of Analysis, in a form required for release of the Product
in the Territory following fill and finish by X. Xxxxx, together with
such other documentation, if any, that is required by customs
regulations for export/import of the Bulk rh[*] into countries in the
Territory where the Product will be filled and finished in final
dosage form suitable for sale. X. Xxxxx shall be responsible for
conducting tests and submitting results which may be required by
Regulatory Authorities for import of Bulk rh[*] into the Territory.
5.10. Terms and Conditions of Sale. All sales of Bulk rh[*] under this
Agreement shall be X WORKS ("EXW", as defined in INCOTERMS,
International Chamber of Commerce, 1990 edition) GTC's designated
production facility. Notwithstanding any proposed variation from
or addition to such terms and conditions appearing on any
purchase order, invoice or any other directions, notices or
instructions submitted by X. Xxxxx, the terms and conditions of
this Agreement shall prevail, unless otherwise agreed to in
writing by the Parties. All freight, insurance and other
shipping arrangements, and the costs and expenses thereof, shall
be made and borne by X. Xxxxx; and all packaging arrangements
necessary to ship the Bulk rh[*] safely and properly, and the
costs and expenses thereof, shall be made and borne by GTC. All
required shipping conditions and methods will be established and
validated by GTC in collaboration with X. Xxxxx. Subject to the
foregoing, title to, and ownership and risk of loss of, the Bulk
rh[*] shall pass to X. Xxxxx upon delivery of the Bulk rh[*] to
the custody and control of X. Xxxxx'x designated carrier at GTC's
designated production facility.
6. Acceptance Testing; Filling and Finishing.
6.1. Testing. For each shipment of Bulk rh[*], X. Xxxxx shall have the
right, within thirty (30) business days of receipt of a shipment, to
test each shipment, using the Acceptance Assay, in order to verify
that the material received by X. Xxxxx meets the Specifications for
such Bulk rh[*], consistent, within the expected variability of such
Acceptance Assay. All Bulk rh[*] which is found by X. Xxxxx, in its
performance of the Acceptance Assay, to be in conformance with the
Specifications, notwithstanding any variations between the results of
GTC's
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release testing and X. Xxxxx'x Acceptance Assay, shall be held
to comply with the Specifications. X. Xxxxx shall promptly inform GTC
of any discrepancies outside of the expected variability of the
Acceptance Assay discovered by X. Xxxxx in performing such Acceptance
Assay. Such shipment shall be held to comply with the Specifications,
unless, within such thirty (30) day period, X. Xxxxx gives GTC written
notice, together with supporting documentation, of non-conformance
with the Specifications discovered by X. Xxxxx. Upon receipt of such
notice, GTC will be given access to such shipment in order to conduct
its own inspection thereof (which inspection shall be conducted within
thirty (30) days of such notice), and the Parties will endeavor to
agree in good faith as to whether such shipment complies with the
Specifications for such Bulk rh[*].
Notwithstanding the foregoing, in the event the Bulk rh[*] delivered
to X. Xxxxx under this Agreement is determined, within one (1) year
from X. Xxxxx'x receipt of the Certificate of Analysis including the
release for such Bulk rh[*] (using the procedures set forth in Section
6.1, above) not to comply with the Specifications, and such
non-compliance was not detected at the time of delivery (a "hidden
defect"), then GTC shall reimburse X. Xxxxx for its direct
out-of-pocket costs associated with the manufacture and any recall of
such Product resulting from such hidden defect.
6.2. Dispute Resolution. If the Parties are unable, after good faith
efforts, to agree within a reasonable time as to any matter set forth
in Sections 6.1 of this Agreement, such matter will be submitted to an
independent quality control laboratory agreed upon by the Parties.
With respect to conformance with the Specifications, if either GTC
concedes or the independent laboratory finds that the Bulk rh[*]
shipped to X. Xxxxx does not conform with the Specifications
applicable for such shipment, GTC, at X. Xxxxx'x option, either shall
supply X. Xxxxx, as soon as possible and at no additional cost to X.
Xxxxx, with an equivalent quantity of Bulk rh[*] which meets the
Specifications, or refund to X. Xxxxx the purchase price for such
non-conforming Bulk rh[*]. In such event, X. Xxxxx will return to GTC
all non-conforming Bulk rh[*] in accordance with GTC's instructions,
at GTC's cost and expense. If either X. Xxxxx concedes or the
independent laboratory finds that GTC's release testing results are
determinative and that such batch complies with the Specifications,
GTC shall have no replacement or refund obligations with respect to
such shipment. The cost of inspections and/or testing conducted by
the independent laboratory shall be borne by the Party whose
determinations with respect to such batch are contrary to the findings
of the independent laboratory.
6.3. Returns. Transfer of title and risk of loss for Bulk rh[*] returned
to GTC pursuant to this Section 6 shall pass to GTC when such returned
Bulk rh[*] is placed in the custody and control of GTC's designated
carrier, consistent with GTC's instructions. The cost of freight,
insurance and handling and other similar costs shall be paid by GTC.
All amounts due by one Party to the other by virtue of this subsection
shall be paid within forty-five (45) days of the end of the month in
which they were invoiced.
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6.4. X. Xxxxx to Fill, Finish and Label Product. X. Xxxxx shall fill,
finish and label the Product in final dosage form suitable for sales
in the Territory, from the Bulk rh[*] supplied to X. Xxxxx by GTC
under this Agreement.
6.5. Expense and Damage Reimbursement. In the event GTC is held to have
willfully breached its manufacturing and delivery obligations under
this Agreement or is held to have been negligent in the manufacture
and delivery of Bulk rh[*] under this Agreement, GTC shall reimburse
and compensate X. Xxxxx for its direct damages and expenses incurred
by X. Xxxxx as a result thereof, unless otherwise stipulated in
Section 12, below.
7. Purchase Price and Payment Terms.
7.1. Bulk rh[*] for Pivotal Clinical Trials. GTC will sell Bulk rh[*] to
X. Xxxxx for use in clinical trials at a Purchase Price (per gram)
equal to GTC's Direct Costs or manufacturing, EX WORKS ("EXW", as
defined in INCOTERMS, International Chamber of Commerce, 1990 edition)
GTC's designated production facility.
7.2. Bulk rh[*] Intended for Commercial Sale.
a. Purchase Price. GTC will sell Bulk rh[*] to X. Xxxxx for
filling, finishing, labeling and sale as a commercial Product
after X. Xxxxx obtains Regulatory Authority approval necessary to
sell the Product, at a Purchase Price (per gram) set forth below:
Quantity Purchased
in Calendar Year Purchase Price (U.S. Dollars)
[*]
b. Minimum Annual Purchase Requirement; Conversion to Co-Exclusive
Rights in Territory. X. Xxxxx has investigated the market
potential in the Territory for the Product, taking into account
all relevant factors. Based on this investigation, X. Xxxxx has
agreed to purchase [*]. For purposes of calculating minimum
annual purchase requirements, the Parties shall consider on
purchases of Bulk rh[*] from GTC for sale in the Territory (i.e.,
not for sales in [*] pursuant to X. Xxxxx'x Co-Marketing Option).
In the event X. Xxxxx fails to purchase the applicable minimum
annual purchase requirement in any calendar year after utilizing
commercially reasonable efforts, GTC's sole remedy shall be to
appoint itself (or its designee) as a co-exclusive distributor
(with X. Xxxxx) of the Product in the Territory; provided,
however, X. Xxxxx may, at its option, preserve exclusivity if,
prior to the end of the calendar in which additional minimum
annual purchase requirement payments are due, it pays to GTC the
balance of the applicable annual minimum purchase requirement
then due for such calendar year. X. Xxxxx'x minimum purchase
obligations under this Section shall be subject to reduction or
suspension, as determined in good
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faith by the Liaison Committee, in the event of force majeure
or legal or Regulatory Authority prohibition or registration
schedule delay to sell Product in a country in the Territory.
7.3. Invoice and Payment. GTC shall invoice X. Xxxxx for the purchase
price associated with each shipment of Bulk rh[*] at the time of
shipment. X. Xxxxx shall make such payments to GTC within forty-five
(45) days of receipt of the applicable invoice. X. Xxxxx will pay GTC
by wire transfer of good and immediately available funds to a bank and
account, as specified in writing by GTC, or by any other means agreed
upon by the Parties. In the event the exchange rate of the German
Xxxx (and subsequently the EURO currency) and the United States Dollar
increases or decreases from the exchange rate applicable on the
Effective Date of this Agreement (in the case of conversion from the
EURO currency, from fixation of the exchange rate between the
applicable currency to the EURO) by more than ten (10) percent, an
adjustment in the payment due GTC under this Section 7 shall be made
on a payment-by-payment basis, whereby each Party will equally share
such increase or decrease. The basis for determining the exchange
rates in effect for the purposes of this Section shall be the exchange
rate for the average of the "buy and sell" rates as published in the
European Edition of the Wall Street Journal on the date of shipment of
the applicable order of Bulk rh[*].
7.4. Taxes. All sales, use, transfer and other taxes and duties imposed
with respect to the Bulk rh[*] or their sale by GTC to X. Xxxxx by any
governmental authority (but excluding any income or franchise taxes of
any kind imposed on GTC) shall be paid by X. Xxxxx, as adjusted if
necessary. The Parties shall cooperate in obtaining and providing to
each other any certificates of exemption or similar document required
to exempt any sales, use or similar tax liability.
8. [*] Co-Marketing Option.
8.1. Exercise by X. Xxxxx. GTC grants to X. Xxxxx an option (the
"Co-Marketing Option") to appoint itself (or a wholly-owned
subsidiary) as a co-exclusive distributor (with GTC) of the Product in
[*], by giving GTC written notice at any time prior to October 2,
1998. If X. Xxxxx exercises the Co-Marketing Option, X. Xxxxx and GTC
shall co-market the Product in [*]; and GTC shall continue to supply
X. Xxxxx with its requirements of Bulk rh[*] under the terms and
conditions of this Agreement. The form of the co-marketing
arrangement shall be agreed upon by the Parties.
8.2. No Right to Sublicense or Appoint Subdistributors. X. Xxxxx'x right
to market, distribute and sell the Product in [*] (itself or through
an Affiliate) may not be sublicensed to third parties which are not
Affiliates, nor may X. Xxxxx appoint a subdistributor for such
Product, without GTC's prior written consent.
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8.3. Consideration. In consideration of the grant of the Co-Marketing
Option and in accordance with the following schedule, X. Xxxxx shall
pay GTC the following payments:
Estimated
Milestone Completion Date
[*]
d. [*]. The Liaison Committee shall consider
using XxXxx, Inc. of Irvine, California as the
contract research organization for the
performance of such preclinical studies.
e. [*].
f. [*]. The clinical plan for such trial shall
be developed in consultation with the Liaison
Committee.
g. [*].
8.4. Payments. All payments to GTC under this Agreement will be made by
wire transfer of good and immediately available funds to a bank and
account, as specified in writing by GTC, or by any other means agreed
upon by the Parties. Payments made to GTC under this Section 8
shall be made in United States Dollars without regard to changes in
exchange rates.
9. X. Xxxxx Obligations to Purchase, Market and Sell Product.
9.1. Purchase Obligation. X. Xxxxx shall be obligated to purchase from GTC
one hundred percent (100%) of its and its Affiliates and distributors
requirements of rh[*] for filling, finishing, labeling and sales as a
commercial Product. Preclinical studies of such rh[*] shall be
conducted by or on behalf of GTC. X. Xxxxx, at its cost and expense,
will process the Bulk rh[*] supplied by GTC and formulate Products
therefrom. With the exception of GTC's obligations hereunder, X.
Xxxxx shall conduct all necessary testing, and shall make all
regulatory filings, necessary to market and sell Products in the
Territory. GTC shall provide X. Xxxxx with all data which relates to
Bulk rh[*] produced under this Agreement and GTC's performance of its
obligations under this Agreement which is reasonably necessary to
support such regulatory filings.
9.2. Area of Activity. X. Xxxxx shall concentrate its activities in
respect of the Product within the Territory. X. Xxxxx shall not,
outside the Territory: (a) seek customers for the Product; (b)
establish any branch or facility to sell the Product; or (c) maintain
any distribution depot for the Product. X. Xxxxx shall not be in
breach of this Section, nor of its obligation to sell Product only in
the Territory, if a third party which is not an Affiliate or
subdistributor of X. Xxxxx sells Product outside the
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Territory.
9.3. Activities. With regard to the final manufacture and marketing of
Product, X. Xxxxx'x obligations under this Agreement shall include,
but shall not be limited to, the activities set forth in this Section
9.3:
a. Product Testing, Labeling and Packaging; Reimbursement of Direct
Costs.
i. Testing for Import, Distribution and Sale. X. Xxxxx shall
perform all testing required to import the Bulk rh[*] to the
Territory and distribute and sell the Product in the
Territory. GTC shall have the right, from time to time, to
send its technical and quality personnel to X. Xxxxx'x
facility to inspect such testing facilities and to inspect
and audit the records and documentation related thereto. X.
Xxxxx shall not subcontract such testing to a third party
which is not a X. Xxxxx Affiliate, without GTC's prior
written consent.
ii. Labeling and Packaging. X. Xxxxx shall label and package
all Product for marketing, distribution and sale in the
Territory.
iii. Inspection and Release of Product. X. Xxxxx shall be
responsible for and shall perform all inspections required
to release, distribute and sell the Product in the
Territory.
b. Promotion and Advertising. X. Xxxxx shall conduct commercially
reasonably educational, promotional and advertising activities
with respect to the Product in the Territory, and in so doing X.
Xxxxx shall perform the following activities:
i. Country Symposia and Trade Shows. X. Xxxxx may provide
representatives from within its organization to participate
in country and local trade and industry meetings,
conventions, shows, symposia and congresses to advance the
sales of the Product.
ii. Advertising. To the extent commercially reasonable, X.
Xxxxx will actively advertise and promote the Product in the
Territory utilizing media and other means of communication
commonly employed in the industry.
c. Distribution, Marketing and Sales. To the extent commercially
reasonable, X. Xxxxx will distribute, market and sell the Product
throughout the Territory, and in so doing will establish, train,
manage and fund a sales force to cover the Territory. The
selection of qualified technical and other personnel for the
sales force shall be at X. Xxxxx'x sole discretion. The sales
force will offer support to health care professionals and
customers of the Product, including, without limitation, such
technical advice, assistance, training and field services as will
promote customer satisfaction with the Product. The sales force
will be conversant in the conventional technical language of the
Product, and shall
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*Confidential Treatment has been requested for the marked portion.
develop sufficient knowledge of the industry and any competitive
products so as to be able to explain to potential customers the
difference between the Product and any such competitive products.
Training and support provided by the sales force shall be rendered
in the language or languages customarily employed in countries in
the Territory.
9.4. Capital, Facilities and Personnel. To the extent commercially
reasonable, X. Xxxxx shall possess sufficient capital, facilities
(including warehouse facilities) and administrative personnel to
support X. Xxxxx'x obligations to test, label, package, market,
transport, store, distribute and sell the Product in the Territory.
9.5. Inventory. X. Xxxxx shall maintain, subject to availability and
delivery of Bulk rh[*] from GTC, a sufficient inventory of the Product
to provide prompt delivery of the Product to its customers in the
Territory.
9.6. Books and Records. For a period of not less than two (2) years, X.
Xxxxx shall maintain and preserve distinct, complete and accurate
books of accounts and inventories (including, without limitation, lot
records) related to all of its activities as a distributor under this
Agreement, and shall make such books and records available to an
independent accountant designated by GTC not more than one (1) time
per year, upon GTC's request and at GTC's cost, for the limited
purpose of confirming the completeness and accuracy of such books and
records.
10. Clinical Trials.
10.1. In the Territory. X. Xxxxx, at is cost and expense, shall be
responsible for all Pivotal Clinical Trials and registration
activities for the Product in the Territory, except for Phase
I/II clinical trials, which are GTC's responsibility.
10.2. In [*]. GTC, at is cost and expense, shall be responsible for
all worldwide Phase I/II clinical trials and clinical development
and registration activities for the Product in [*].
10.3. Cost-Sharing upon Exercise of Co-Marketing Option. Upon exercise
by X. Xxxxx of the Co-Marketing Option set forth in Section 8,
above, the Parties will agree upon budgets of [*] Pivotal
Clinical Trials and the initial regulatory registration of the
Product in [*]. X. Xxxxx shall pay fifty percent (50%) of the
costs of such Pivotal Clinical Trials up to a maximum payment by
X. Xxxxx of [*]. X. Xxxxx shall pay GTC fifty percent (50%) of
this amount as costs of the Pivotal Clinical Trials are incurred,
if the initial costs of such Pivotal Clinical Trials are less
than [*], with the balance due upon completion of such trials and
analysis of the data therefrom.
10.4. Clinical Data and Regulatory Filings. Each Party shall make
available to the other all of its clinical and formulation data
and regulatory filings free of charge. The Parties shall discuss
and coordinate the further exchange of information and data as is
necessary to obtain and maintain regulatory approval of the
Product. Each party shall have a royalty-free, non-exclusive
license, with the right to sublicense, to use
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all of the data and information furnished under this Section for
the sole and exclusive purposes of conducting clinical testing
and obtaining or maintaining regulatory approval of the Product,
in the Territory in the case of X. Xxxxx, and in [*] in the case
of GTC. GTC may share such clinical data and regulatory filings
with its [*] designee, under appropriate confidentiality
restrictions, for such designee to obtain and maintain regulatory
approval of the Product in [*]. Each Party agrees, to the extent
practical, to provide the other Party with the opportunity to
review and comment on all regulatory filings and material
correspondence with regulatory agencies. Each Party shall have
the right to attend meetings the other Party has with regulatory
authorities which relate to the Product.
11. Licenses and Royalties.
11.1. Grant. Subject to the fulfillment of the terms and conditions of
this Agreement, GTC grants to X. Xxxxx:
a. an exclusive license under the GTC Patent Rights and GTC's
interest in the Project Patent Rights; and
b. an exclusive license to use the GTC Technology and GTC's
interest in the Project Technology,
with the right to grant sublicenses (except as provided below),
for the sole and exclusive purposes, restricted to the Field, of
(i) filling, finishing and labeling Product from Bulk rh[*]
supplied by GTC under this Agreement, (ii) conducting Pivotal
Clinical Trials on the rh[*], and (iii) using, importing and
exporting, marketing and selling the Products, in the Territory.
The license granted pursuant to Section 11.1.a. shall continue in
effect until the expiration of the last patent licensed to
X. Xxxxx hereunder. The license granted pursuant to
Section 11.1.b. shall continue in effect for ten (10) years from
the date of first commercial sale of a Product within the
Territory; provided, however, X. Xxxxx shall have a renewable
right to extend such license for successive terms by delivery of
written notice to GTC.
In the event X. Xxxxx exercises the Co-Marketing Option set forth
in Section 8, above, the license set forth in this Section 11.1
shall be expanded to include a non-exclusive license under the
GTC Patent Rights and Project Patent Rights and a non-exclusive
license to use the GTC Technology and Project Technology in [*],
under the terms and conditions set forth above, except that
X. Xxxxx shall not be permitted to sublicense such rights to
third parties which are not Affiliates in [*].
11.2. Reservation of Rights. GTC reserves for itself, its Affiliates,
other corporate partners, sublicensees and third party designees
the right under the GTC Patent Rights and the GTC Technology and
its interest in the Project Patent Rights and Project Technology
to (a) produce Bulk rh[*], (b) conduct clinical trials on such
Product in [*], and (c) use, import and sell such Products in
[*]. With respect to GTC's retained rights to market and sell
Products in [*], GTC's sublicense rights
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shall be limited to the right to license a single entity.
11.3. Conversion to Non-Exclusive Licenses. In the event that X. Xxxxx
fails to meet the minimum annual purchase requirements set forth
in Section 7.2(b), above, after using commercially reasonable
efforts, GTC shall have as its sole remedy the right, in its sole
discretion and upon thirty (30) days prior written notice to X.
Xxxxx, to convert the license set forth in Section 11.1, above,
from exclusive to non-exclusive; provided, however, X. Xxxxx may,
at its option, preserve the exclusivity of such license if,
within said thirty (30) day period, it pays to GTC the balance of
the annual minimum purchase requirement then due for such
calendar year. This provision shall be subject to suspension, as
determined in good faith by the Liaison Committee, in the event
of force majeure or legal or Regulatory Authority prohibition or
registration schedule delay to sell Product in a country in the
Territory.
11.4. Exclusivity. During the term of this Agreement, and for as long
as the license set forth in Section 11.1, above, has not been
terminated or converted to non-exclusive, X. Xxxxx and GTC agree
that each will work exclusively with the other with respect to
the development, production and manufacture of any recombinant
human [*], and agree not to develop, produce, manufacture or sell
(or collaborate or work with any third party to develop,
manufacture or sell), any form of recombinant human [*] except as
provided in this Agreement, nor have this done by third parties.
Notwithstanding the foregoing, and subject to the other
provisions of this Agreement, GTC may subcontract to, and work
and/or collaborate with, third parties with respect to the
development and manufacture of Transgenic Goats which produce
rh[*] in their milk, and for the production of such rh[*] from a
Production Herd only for the purposes of this Agreement.
11.5. GTC Rights in Territory. In the event that X. Xxxxx elects not
to file for regulatory approval for a Product in a country in the
Territory within one (1) year following completion of a Pivotal
Clinical Trial, or if approval is obtained in a country and X.
Xxxxx elects within a commercially reasonable period not to
market and sell a Product in such country, then GTC shall have
the non-exclusive right itself or through an Affiliate or
sublicensee to use, import and sell the Product in such country.
11.6. Royalties. Royalty payments to GTC under this Section 11.6 are
subject to the existence of one or more valid claims under the
GTC Patent Rights or Project Patent Rights, or the existence of
GTC Technology or Project Technology which is not available to
third parties (other than permitted third parties under this
Agreement).
a. Sales of Products in Territory. Beginning one (1) year
following commercial launch of the Product, and following
Regulatory Authority approval in a country in the Territory
to market and sell Products, X. Xxxxx shall pay to GTC
royalties on Net Sales Price of each Product sold by
X. Xxxxx, its Affiliates and/or sublicensees in such
countries in the Territory, as follows:
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Annual Net Sales Percentage
[*]
b. Sales of Products in [*]. In addition to the foregoing
royalties, in the event X. Xxxxx exercises its Co-Marketing
Option, X. Xxxxx shall pay to GTC royalties on Net Sales
Price of each Product sold by X. Xxxxx and/or its Affiliates
in [*], as follows:
Annual Net Sales Percentage
[*]
11.7. Reports and Payment. X. Xxxxx shall deliver to GTC, within sixty
(60) days after the end of each calendar quarter, a written
report showing its computation of royalties due under this
Agreement upon Net Sales during such calendar quarter. All Net
Sales shall be segmented in each such report according to sales
on a country-by-country basis, including the rates of exchange
used to convert such royalties to United States Dollars from the
EURO-currency or other currency in which such sales were made
(in the case of conversion from the EURO currency, from fixation
of the exchange rate between the applicable currency to the
EURO). Simultaneously with the delivery of each such report, X.
Xxxxx shall tender payment in United States Dollars of all
royalties shown to be due therein.
In the event the exchange rate of the German Xxxx (and
subsequently the EURO currency) and the United States Dollar
increases or decreases from the exchange rate applicable on the
Effective Date of this Agreement by more than ten (10) percent,
an adjustment in the payment due GTC under this Section 11 shall
be made on a payment-by-payment basis, whereby each Party will
equally share such increase or decrease. The basis for
determining the exchange rates in effect for the purposes of this
Section shall be the exchange rate for the average of the "buy
and sell" rates as published in the European Edition of the Wall
Street Journal on the first and last days of the calendar quarter
for which payment is due.
11.8. Foreign Royalties. Where royalties are due hereunder for sales
of Products in a country where, by reason of currency regulations
or taxes of any kind, it is impossible or illegal for X. Xxxxx to
transfer royalty payments to GTC for Net Sales in that country,
such royalties shall be deposited in whatever currency is
allowable by the person or entity not able to make the transfer
for the benefit or credit of GTC in an accredited bank in that
country that is reasonably acceptable to GTC.
11.9. Taxes. Any and all income or similar taxes imposed or levied on
account of the receipt of royalties payable under this Agreement
which are required to be withheld by X. Xxxxx shall be paid by X.
Xxxxx on behalf of GTC and shall be paid to the proper taxing
authority. Proof of payment shall be secured and sent to GTC by
X. Xxxxx as evidence of such payment in such form as required by
the tax authorities having jurisdiction over X. Xxxxx. Such
taxes shall be deducted from the royalty that would otherwise be
remittable by X. Xxxxx.
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11.10. Records. X. Xxxxx shall keep, and shall require all Affiliates
and any permitted sublicensees to keep, for a period of at least
two (2) years, full, true and accurate books of accounts and
other records containing all information and data which may be
necessary to ascertain and verify the royalties payable
hereunder. During the term of this Agreement and for a period of
two (2) years following its termination, GTC, at its costs,
shall have the right from time to time (not to exceed once during
each calendar year) during normal business hours to have an
independent agent, accountant or other representative inspect in
confidence, such books, records and supporting data.
11.11. Payment Method. X. Xxxxx will pay GTC by wire transfer of good
and immediately available funds to a bank and account, as
specified in writing by GTC, or by any other means agreed upon by
the Parties.
12. Representations, Warranties, Indemnities and Insurance.
12.1. Representations and Warranties by GTC. GTC hereby represents and
warrants to X. Xxxxx as follows:
a. Organization and Good Standing. GTC is a corporation duly
organized, validly existing and in good standing under the
laws of the Commonwealth of Massachusetts and has full
corporate power and authority to conduct its business as
presently conducted and as proposed to be conducted by it
and to enter into and perform this Agreement, and to carry
out its obligations hereunder and the other transactions
contemplated by this Agreement.
b. Authority for Agreement. The execution, delivery and
performance by GTC of this Agreement has been duly
authorized by all necessary corporate action. The execution
and performance of the transactions contemplated by this
Agreement and compliance with its provisions by GTC will not
conflict with or result in any breach of any of the terms,
conditions or provisions of, or constitute a default under
any indentures lease, agreement or other instrument to which
GTC is a party or by which it or any or its properties is
bound, or any decree, judgment, order, statute, rule or
regulation known by GTC to be applicable to it.
c. Governmental Consents. To GTC's knowledge no consent,
approval, order or authorization of, or registration,
qualification, designation, declaration or filing with, any
governmental authority is required on the part of GTC in
connection with the execution of this Agreement or the
transactions contemplated by this Agreement.
d. No Known Infringement. Following diligent inquiry, including
worldwide patent searches conducted by outside patent
counsel, GTC is unaware of any infringement of the perfected
and valid intellectual property rights of any third party,
or any claim of such infringement by any third party, that
would arise
21
upon the immediate use of any gene construct or other
material presently contemplated to be furnished by GTC to
X. Xxxxx pursuant to this Agreement, or from the presently
contemplated and proposed activities of GTC pursuant to this
Agreement, including, without limitation, the production of
Bulk rh[*] and its sale as part of the Product. The Parties
acknowledge that the perfected and valid intellectual
property rights of third parties relating to recombinant
human [*] materially vary from country to country (for
example, third party patent rights exist in some countries
but not in others; and such patent rights will expire at
different times in different countries). Therefore, GTC's
representation and warranty to X. Xxxxx under this
Subsection (d) is applicable as of the Effective Date only
with respect to those countries in which perfected and valid
third party intellectual property rights do not exist (for
example, without limitation, in [*]). GTC will provide
X. Xxxxx with a copy of the report from its outside patent
counsel within fifteen (15) business days following the
Effective Date, confirming GTC's warranty under this
Subsection (d) with respect to patent rights of third
parties. GTC further represents and warrants to X. Xxxxx
that the relevant intellectual property rights of third
parties which do exist as of the Effective Date should
expire in time for X. Xxxxx to have broad marketing rights
for the Product in the Territory, consistent with the
commercialization schedule set forth in this Agreement.
e. Production of Bulk rh[*]. GTC represents and warrants to X.
Xxxxx that GTC's production of the Bulk rh[*] shall be
performed in accordance with GTC's standard operating
procedures under the supervision and control of its qualified
personnel. GTC further warrants that the Bulk rh[*] supplied
to X. Xxxxx under this Agreement shall meet the
Specifications at the time of delivery, shall not be
adulterated or misbranded within the meaning of the Federal
Food, Drug and Cosmetic Act in effect at the time of
delivery, and shall meet the applicable Regulatory Authority
requirements.
f. No Other Licenses. GTC represents and warrants to X. Xxxxx
that GTC has not granted rights to the GTC Patent Rights or
GTC Technology to third parties for use in the Field in the
Territory [*]. GTC further represents and warrants to
X. Xxxxx that, following diligent inquiry, including
worldwide patent searches conducted by outside patent
counsel, GTC is unaware of any infringement of the perfected
and valid intellectual property rights of [*], or any claim
of such infringement by [*], which would arise by the
performance of the rights granted to X. Xxxxx under this
Agreement, and GTC will defend, indemnify and hold harmless
X. Xxxxx and its Affiliates, permitted subdistributors,
agents, directors, officers and employees, at GTC's cost and
expense, from and against any and all losses, costs,
liabilities, damages, fees and expenses, including reasonable
attorneys' fees and expenses, incurred in connection with
any claim, action or proceeding brought by [*] and arising
out of or in connection a breach of GTC's representation and
warranty contained in this Subsection (f).
g. GTC Patent Rights. GTC represents and warrants to X. Xxxxx
that the issued
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patents listed in Schedule B to this Agreement are valid
and effective as of the Effective Date.
h. Exclusivity of Warranty and Limitation of Remedies. The
warranties made by GTC in this Section 12.1 are in lieu of
all other representations and warranties, express or
implied, including, but not limited to, implied warranties
of merchantability or fitness for a particular purpose.
12.2. Representations and Warranties by X. Xxxxx. X. Xxxxx hereby
represents and warrants to GTC as follows:
a. Organization. X. Xxxxx is a German corporation duly
organized and validly existing under the laws of Germany
and has full power and authority to enter into and perform
this Agreement, and to carry out the transactions
contemplated by this Agreement.
b. Authority for Agreement. The execution, delivery and
performance by X. Xxxxx of this Agreement has been duly
authorized by all necessary corporate action, and has been
duly executed and delivered by X. Xxxxx. The execution
and performance of the transactions contemplated by this
Agreement and compliance with its provisions by X. Xxxxx
will not conflict with or result in any breach of any of
the terms, conditions or provisions of, or constitute
default under, any indentures, lease, agreement or other
instrument to which X. Xxxxx is a party or by which it or
any or its properties is bound, or any decree, judgment,
order, statute, rule or regulation known by X. Xxxxx to be
applicable to it.
c. Governmental Consents. To X. Xxxxx'x knowledge, except as
provided herein, no consent, approval, order or
authorization of, or representation, qualification,
designation, declaration, or filing with any governmental
authority is required on the part of X. Xxxxx in
connection with the execution of this Agreement or the
transactions contemplated by this Agreement.
d. No Infringement. X. Xxxxx is unaware of any infringement
of the perfected and valid rights of any third party, or
any claim of such infringement by any third party, that
would arise upon the use of any gene construct or other
material presently contemplated to be furnished or
obtained by X. Xxxxx pursuant to this Agreement, or from
the contemplated activities of X. Xxxxx pursuant to this
Agreement.
e. Exclusivity of Warranty and Limitation of Remedies. The
warranties made by X. Xxxxx in this Section 12.2 are in
lieu of all other representations and warranties, express
or implied, including, but not limited to, implied
warranties of merchantability or fitness for a particular
purpose.
12.3. Limitation of Liability. Unless otherwise specifically provided
for in this Agreement, neither Party will be liable for any lost
profits arising out of the such
23
Party's performance or non-performance of its obligations under
this Agreement, whether any such damages are based on a claim
of negligence, strict liability, breach of warranty or
otherwise. Neither Party will be liable for any other
indirect, incidental, consequential or special damages arising
out of such Party's performance or non-performance of its
obligations under this Agreement, whether any such damages are
based on a claim of negligence, strict liability, breach of
warranty or otherwise; provided, however, a Party may be liable
for such other indirect, incidental, consequential or special
damages in the event such Party is held to have willfully
breached its material obligations under this Agreement or is
held to have been negligent in its performance of its
obligations hereunder.
12.4. Indemnification by X. Xxxxx. X. Xxxxx agrees to defend,
indemnify and hold harmless GTC and its Affiliates, agents,
directors, officers and employees, at X. Xxxxx'x cost and
expense, from and against any and all losses, costs, liabilities,
damages, fees and expenses, including reasonable attorneys' fees
and expenses (collectively, "Liabilities") incurred in connection
with any claim, action or proceeding brought by a third party and
arising out of or in connection with any and all import testing,
filling, finishing, labeling, packaging, registration,
inspection, marketing, sale, distribution or any other activities
related to the Product which are performed by or on behalf of X.
Xxxxx, including, but not limited to, any actual or alleged
injury, damage, death or other consequence occurring to any
person as a result, directly or indirectly, of the possession,
consumption or use of the Product, regardless of the form in
which any such claim is made.
X. Xxxxx'x obligation to defend and indemnify GTC under this
Section 12.4 shall not apply to the extent that the existence
or incurrence of any such Liabilities is attributable to the
negligence, breach of warranty, recklessness, fault, errors or
omissions, misconduct, or otherwise of GTC or its Affiliates,
subdistributors, agent, directors, officers and employees.
12.5. Indemnification by GTC. GTC agrees to defend, indemnify and hold
harmless X. Xxxxx and its Affiliates, permitted subdistributors,
agents, directors, officers and employees, at GTC's cost and
expense, from and against any and all Liabilities incurred in
connection with any claim, action or proceeding brought by a
third party and arising out of or in connection with any actual
or alleged injury, damage, death or other consequence occurring
to any person as a result, directly or indirectly, of a Product
defect arising from GTC's production of Bulk rh[*], regardless of
the form in which any such claim is made.
GTC's obligation to defend and indemnify X. Xxxxx under this
Section 12.5 shall not apply to the extent that the existence
or incurrence of any such Liabilities is attributable to the
negligence, breach of warranty, recklessness, fault, errors or
omissions, misconduct, or otherwise of X. Xxxxx or its
Affiliates, subdistributors, agent, directors, officers and
employees.
12.6. Defense of Claims. In the event of any such claim against a
Party or its Affiliates, subdistributors, agents, directors,
officers or employees, the indemnified Party shall
24
*Confidential Treatment has been requested for the marked portion.
promptly notify the indemnifying Party in writing of the claim
and the indemnifying Party shall manage and control, at its sole
expense, the defense of the claim and its settlement. The
indemnified Party shall cooperate with the indemnifying Party
and may, at its option and at its own expense, be represented
in any such action or proceeding. The indemnifying Party shall
not be liable for any settlements, litigation costs, or expenses
incurred by the indemnified Party without the indemnifying
Party's written consent, such consent to be promptly given and
not unreasonably withheld.
12.7. Liability Insurance. Each Party shall secure and maintain at its
own expense during the term of this Agreement an adequate
insurance policy or policies with an insurer or insurers,
protecting the Party against any and all risks typically insured
against by businesses comparable to the Party, including without
limitation general and products liability, arising or occurring
upon or in connection with each Party's business. Such policy or
policies or program shall include general and products liability
coverage in an amount typically secured by businesses comparable
to the Party. Each Party shall furnish the other Party with
certificates evidencing all such insurance.
13. Pharmacovigilance Programs. If either Party receives any complaints
(excluding customer service-related complaints) relating to the
manufacture and use of Product, including adverse reaction reports, it
promptly shall notify the other Party of such complaints and reports;
provided, however, that in the case of adverse reaction reports
concerning "serious adverse experiences" (as such term, or analogous
terms, are defined by the Regulatory Authorities in any country in the
Territory, as applicable), such Party immediately shall notify the other
Party by telefax and/or telephone of such report, but in no event more
than two (2) working days after receipt of such report. Following
execution of this Agreement, GTC and X. Xxxxx promptly shall agree upon a
written policy for reporting adverse experiences which will comply with
all applicable Regulatory Authority requirements.
14. Proprietary Rights.
14.1. Ownership. GTC shall own for itself all GTC Patent Rights and
GTC Technology. The Parties shall jointly own all Project Patent
Rights and Project Technology. Either Party is free to use its
ownership interest in the Project Patent Rights and Project
Technology outside the scope of this Agreement; provided,
however, neither Party shall use such ownership interest in
collaboration with a third party, or license such ownership
interest to a third party, without notifying the other Party, and
the other Party may object to such collaboration or license
within thirty (30) days of notice thereof, if it can be
reasonably demonstrated that such collaboration or license would
materially disadvantage such Party's business interests.
14.2. Filing and Maintenance of Patents.
a. Project Patent Rights. The Parties shall cooperate with
respect to decisions whether or not to seek or continue to
seek or maintain patent protection on the Project Patent
Rights in any country in the world, and shall have the
right, jointly in both their names, to file for, procure,
and maintain patents on any
25
such Project Patent Rights in any country in the world,
with the expenses being shared equally by the Parties. If
one Party elects not to seek or continue to seek or
maintain patent protection on any Project Patent Rights in
any country in the world, the other Party shall have the
right, in its name, to file, procure and maintain in such
countries patents on such Project Patent Rights, with the
expenses being borne by such Party.
b. GTC Patent Rights. GTC shall have the right and
responsibility to decide whether or not to seek or
continue to seek or maintain patent protection on the GTC
Patent Rights in any country in the world, and shall have
the right to file for, procure, and maintain patents on
any such GTC Patent Rights in any country in the world,
with the expenses being borne by GTC. If GTC elects not
to seek or continue to seek or maintain patent protection
on any GTC Patent Rights in any country in the world, and
GTC has the right to permit X. Xxxxx to file, procure and
maintain in such countries patents on such GTC Patent
Rights, X. Xxxxx shall have the right, in its name, to
file, procure and maintain in such countries patents on
such GTC Patent Rights, with the expenses being borne by
X. Xxxxx, and the rights under such GTC Patent Rights
thereafter shall be transferred to X. Xxxxx. GTC agrees
to advise X. Xxxxx of all decisions taken under this
Subsection in a timely manner, but in any case at least
ninety (90) days prior to the time any action is required,
in order to allow X. Xxxxx to protect the Parties'
ownership and license interests in the GTC Patent Rights.
14.3. Patent Cooperation. Each Party shall provide the other Party
with copies of all substantive communications from all patent
offices regarding applications or patents on any Project Patent
Rights and Project Technology promptly after the receipt
thereof. Each Party shall provide the other Party with copies of
all proposed substantive communications to such patent offices
regarding applications or patents on any such Project Patent
Rights in sufficient time before the due date in order to enable
the other Party an opportunity to comment on the content thereof.
Each Party shall make available to the other Party or its
authorized attorneys, agents, or representatives, such of its
employees whom the other Party in its reasonable judgment deems
necessary in order to assist it in obtaining patent protection
for the Project Patent Rights. Each Party shall sign or use its
best efforts to have signed all legal documents necessary to file
and prosecute patent applications or to obtain or maintain
patents at no cost to the other Party.
14.4. Infringement.
a. Each Party shall promptly report in writing to the other
Party during the term of this Agreement any known (1)
infringement or suspected infringement or (2) unauthorized
use or misappropriation of any of the GTC Patent Rights or
Project Patent Rights in the Territory, and shall provide
the other Party with all available evidence supporting
said infringement, suspected infringement or unauthorized
use or misappropriation.
26
b. GTC Patent Rights.
i. GTC shall have the sole and exclusive right to
initiate an infringement or other appropriate suit
anywhere in the Territory against any third party who
at any time has infringed or misappropriated, or is
suspected of infringing or misappropriating, any of
the GTC Patent Rights. GTC shall give X. Xxxxx
sufficient advance notice of its intent to file said
suit and the reasons therefore, and shall provide X.
Xxxxx with an opportunity to make suggestions and
comments regarding such suit. GTC shall keep X.
Xxxxx promptly informed, and shall from time to time
consult with X. Xxxxx regarding the status of any
such suit. In the event that GTC decides not to
initiate an infringement or other appropriate suit
pursuant to this Subsection (b)(i), GTC shall
promptly advise X. Xxxxx of its intent not to
initiate such suit; provided, however, GTC shall
bring infringement or other appropriate actions
against third parties against which a credible claim
of infringement or misappropriation may be asserted,
unless GTC can reasonably demonstrate to X. Xxxxx
that the consequences of such action against such
third parties could materially injure GTC's
intellectual property or other business interests.
In any event, upon written request by X. Xxxxx to
make an election, GTC shall elect to file a suit no
later than one hundred twenty (120) days following
such request, and if GTC has failed to initiate suit
within said one hundred twenty (120) day period, X.
Xxxxx shall have the right to the remedies set forth
in Subsection (b)(iii), below.
ii. GTC shall have the sole and exclusive right to select
counsel for any suit referred to in Subsection
(b)(i), above, and shall, except as provided below,
pay all expenses of the suit, including without
limitation attorneys' fees and court costs. If
necessary or desirable in GTC's sole opinion, X.
Xxxxx or its Affiliates shall join as a party to the
suit but shall be under no obligation to participate
except to the extent that such participation is
required as the result of being a named party to the
suit. X. Xxxxx shall offer reasonable assistance to
GTC in connection therewith at no charge to GTC
except for reimbursement of reasonable out-of-pocket
expenses, including reasonable attorneys' fees,
incurred in rendering such assistance. X. Xxxxx
shall have the right to participate and be
represented in any such suit by its own counsel at
its own expense. If GTC requires X. Xxxxx to join in
such suit, GTC shall defend, indemnify and hold
harmless X. Xxxxx against any claim arising out of
such suit or any claim for injunctive or other
relief.
iii. In the event GTC decides not to initiate a suit or
fails to elect to file a suit within the one hundred
twenty (120) day time period set forth in Subsection
(b)(ii), above, where GTC has the legal right and
standing to bring such suit, and such election has a
material and adverse affect on X. Xxxxx'x market
share with respect to sales of the Product in one or
more of the countries in the Territory in which X.
Xxxxx is exercising commercially reasonable and
diligent efforts to distribute and sell the Product,
then X. Xxxxx may be relieved of a percentage of its
annual
27
minimum purchase requirements, with such percentage
being equal to the percentage of X. Xxxxx'x
Territory-wide sales of Product which occurred in
such country or countries during the prior annual
sales period.
c. Project Patent Rights.
i. The Parties shall cooperate in electing whether or
not to initiate an infringement or other appropriate
suit against any third party who at any time has
infringed, or is suspected of infringing, any of, or
of using without proper authorization all or any
portion of, the Project Patent Rights. Each Party
shall decide, no later than ninety (90) days
following written notice from the other Party of
infringement pursuant to Subsection (a), above,
whether to participate in such infringement or other
appropriate suit.
ii. The Parties shall have the joint right to select
counsel for any suit referred to in Subsection
(c)(i), above and shall, except as provided below,
jointly pay in equal parts all expenses of the suit,
including without limitation attorneys' fees and
court costs. Each Party (except as provided below)
shall be entitled to retain fifty percent (50%) of
any damages, royalties, settlement fees, or other
consideration for infringement resulting therefrom.
iii. In the event that one Party elects not to participate
in such infringement or other appropriate suit
pursuant to subsection (c)(ii), above, that Party
shall promptly advise the other Party of its intent
not to participate in such suit, and the other Party
shall have the right, at its own expense, of
initiating an infringement or other appropriate suit
against any third party who at any time has
infringed, or is suspected of infringing, or of using
without proper authorization all or any portion of
such Project Patent Rights. In exercising its rights
pursuant to this subsection (c)(iii), the
participating Party shall have the sole and exclusive
right to select counsel and shall, except as provided
below, pay all expenses of the suit including without
limitation attorneys' fees and court costs. The
participating Party shall be entitled to retain any
damages, royalties, settlement fees, or other
consideration which are attributable to infringement
resulting therefrom. If necessary, the other Party
shall join as a party to the suit but shall be under
no obligation to participate except to the extent
that such participation is required as a result of
being a named party to the suit. At the
participating Party's request, the other Party shall
offer reasonable assistance to the participating
Party in connection therewith at no charge to the
participating Party except for reimbursement of
reasonable out-of-pocket expenses incurred in
rendering such assistance. The participating Party
shall not settle any such suit involving rights of
the other Party in the Project Patent Rights without
obtaining the prior written consent of the other
Party, which consent shall be promptly given and
shall not be unreasonably withheld.
28
14.5. Claimed Infringement.
a. In the event that a third party at any time provides
written notice of a claim to, or brings an action, suit or
proceeding against, either Party or any of their
respective Affiliates, claiming infringement of its patent
rights or unauthorized use or misappropriation of its
know-how, based upon an assertion or claim arising out of
the development, manufacture and/or sale of the Bulk rh[*],
such Party shall promptly notify the other Party of the
claim or the commencement of such action, suit or
proceeding, enclosing a copy of the claim and/or all
papers served.
b. GTC shall attempt, at its costs, to resolve the problem
raised by the asserted infringement in one of the
following ways:
i. obtain a license permitting GTC and X. Xxxxx to make,
have made, use and sell Bulk rh[*] as part of the
Product in the country or countries in question; or
ii. obtain a written statement from such third party
that:
(1) no action will be taken against GTC or X. Xxxxx
and their respective Affiliates, sublicensees or
distributors for the manufacture, use or sale of
Bulk rh[*] as part of the Product; or
(2) the patent or other third party right is not
infringed by the formulation, manufacture, use
or sale of Bulk rh[*] as part of the Product; or
(3) obtain a holding that the third party patent is
invalid or the third party patent or other right
is unenforeceable or not infringed by a court of
competent jurisdiction from which no appeal has
or can be taken.
In the event that X. Xxxxx has given written notice to GTC
that a third party has claimed or alleged that the
manufacture, use or sale of Bulk rh[*] as part of the
Product constitutes an infringement of its patent or
patents or industrial property rights against X. Xxxxx,
its Affiliates, sublicensees or distributors and GTC does
not undertake, within sixty (60) days of such notice, to
defend and/or settle such claim or allegation as described
above, X. Xxxxx shall have the right to retain the
royalties otherwise payable to GTC under this Agreement
and to use such royalties to pay for or defray the actual
expended costs of defending each such claim or allegation,
including the costs of settling or satisfying said claim
or allegation. X. Xxxxx shall not settle or satisfy such
claim or allegation in a manner which affects GTC's rights
under the GTC Patent Rights, GTC Technology, Project
Patent Rights or Project Technology without GTC's prior
written consent. During the defense of such claims or
allegations, X. Xxxxx shall submit documentation showing
royalties accruing to
29
*Confidential Treatment has been requested for the marked portion.
GTC and the expenses of defending against the claims or
allegations of infringement. In the event such claim or
allegation is resolved, X. Xxxxx shall promptly return to
GTC any amount of withheld royalties in excess of the
costs expended by X. Xxxxx in resolving such claim or
allegation.
If, under the preceding paragraph, GTC settles or
satisfies such claim or allegation of patent or industrial
property right infringement, then GTC shall be responsible
for any payments to third parties to settle or satisfy
such claim or allegation. If, under the preceding
paragraph, X. Xxxxx xxxxxxx or satisfies such claim or
allegation of patent or industrial property right
infringement, then X. Xxxxx shall be entitled to deduct
fifty percent (50%) of those payments or royalties paid to
such third party from the royalties due to GTC under this
Agreement, up to a maximum of fifty percent (50%) of the
royalties otherwise due GTC hereunder.
15. Confidential Information.
15.1. Treatment of Confidential Information. Each Party shall maintain
the Confidential Information of the other Party in confidence,
and shall not disclose, divulge or otherwise communicate such
Confidential Information to others, or use it for any purpose,
except pursuant to, and in order to carry out, the terms and
objectives of this Agreement, and hereby agrees to exercise every
reasonable precaution to prevent and restrain the unauthorized
disclosure of such Confidential Information by any of its
directors, officers, employees, consultants, subcontractors,
sublicensees or agents. The Parties' confidentiality obligations
shall expire ten (10) years following termination of this
Agreement.
15.2. Release from Restrictions. The provisions of Section 15.1 shall
not apply to any Confidential Information disclosed hereunder
which:
a. was known or used by the receiving Party or its Affiliates
prior to its date of disclosure to the receiving Party, as
evidenced by the prior written records of the receiving
Party or its Affiliates; or
b. either before or after the date of the disclosure to the
receiving Party is lawfully disclosed without restriction
to the receiving Party or its Affiliates by an
independent, unaffiliated third party rightfully in
possession of the Confidential Information (but only to
the extent of the rights received from such third party);
or
c. either before or after the date of the disclosure to the
receiving Party becomes published or generally known to
the public through no fault or omission on the part of the
receiving Party or its Affiliates; or
d. is required to be disclosed by the receiving Party or its
Affiliates to comply with applicable laws, to defend or
prosecute litigation or to comply with governmental
regulations, provided that the receiving Party provides
prior
30
written notice of such disclosure to the other Party and
takes reasonable and lawful actions to avoid and/or
minimize the degree of such disclosure.
15.3. Publications. The following restrictions shall apply with
respect to the disclosure in scientific journals or
publications by either Party or any employee or consultant of
either Party relating to any scientific work relating to the
Product and/or Final Product:
a. The publishing Party shall provide the other Party with an
advance copy of any proposed publication (which may be in
draft form) relating to the Product/Final Product, and the
other Party shall have a reasonable opportunity to
recommend any changes it reasonably believes are necessary
to preserve patent rights or know-how licensed to or owned
in whole or in part by the other Party, or are otherwise
necessary to promote or protect the interests of the other
Party, and the incorporation of such recommended changes
shall not be unreasonably refused;
b. if the other Party informs the publishing Party, within
thirty (30) days of receipt of an advance copy of a
proposed publication, that such publication in its
reasonable judgment could be expected to have a material
adverse effect on any patent rights or know-how licensed
to or owned in whole or in part by the other Party, the
publishing Party shall, to the extent permitted by its
agreements with its employees and consultants, delay or
prevent such publication as proposed. In the case of
inventions, the delay shall be sufficiently long to permit
the timely preparation and filing of a patent
application(s) or application(s) for a certificate of
invention on the information involved; and
c. if the other Party informs the publishing Party, within
thirty (30) days of receipt of an advance copy of a
proposed publication, that such publication in its
reasonable judgement could be expected to have a material
adverse effect on the interests of the other Party, the
Parties shall discuss the publication and, if mutually
agreeable, the publishing Party shall, to the extent
permitted by its agreements with its employees and
consultants, delay or prevent such publication as agreed.
15.4. Permissible Uses of Confidential Information. The foregoing
provisions shall not preclude the disclosure of Confidential
Information as necessary for (a) the Parties' performance of this
Agreement, (b) the manufacture of Bulk rh[*] by GTC, (c) the
manufacture and marketing of the Product by X. Xxxxx pursuant to
this Agreement or (d) X. Xxxxx'x filing and prosecution of
applications with Regulatory Authorities for the manufacture,
sale and use of the Product in the Territory or the manufacture
of the Bulk rh[*] by GTC.
16. Termination.
16.1. Term. The term of this Agreement (the "Term") will commence on
the Effective Date and will continue for so long as one or more
valid claims under the GTC Patent
31
*Confidential Treatment has been requested for the marked portion.
Rights or Project Patent Rights, or GTC Technology or Project
Technology which is not available to third parties (other than
permitted third parties under this Agreement), exists, unless
terminated sooner pursuant to the express provisions of this
Agreement.
16.2. Termination for Breach.
a. General Provision. Each Party shall be entitled to
terminate this Agreement by written notice to the other
Party in the event that the other Party shall be in
material default of any of its obligations hereunder, and
shall fail to remedy any such default within sixty (60)
days after notice thereof by the non-breaching Party. Any
such notice shall specifically state that the
non-breaching Party intends to terminate this Agreement in
the event that the breaching Party shall fail to remedy
the default in said period. Upon termination of this
Agreement pursuant to this Section 16.2, neither Party
shall be relieved of any obligations incurred prior to
such termination. The Parties acknowledge that material
breach by X. Xxxxx or GTC of its obligations hereunder
shall be considered valid grounds for termination under
this Section 16.2.
b. Partial Termination Where X. Xxxxx is the Breaching Party.
Notwithstanding anything contained in this Section 16.2 to
the contrary, if X. Xxxxx is the breaching Party and if X.
Xxxxx'x default (a) primarily occurred in or primarily
affects a particular country or group of countries which
are part of the Territory and (b) does not materially
adversely affect (i) X. Xxxxx'x ongoing ability to fully
perform its obligations under this Agreement in the other
countries specified in this Agreement or (ii) GTC's
reputation or its ongoing ability to perform its
obligations under this Agreement, then GTC shall have the
right to terminate X. Xxxxx'x rights under this Agreement
with respect to the country or group of countries in which
the default occurred or primarily affects. Upon such
partial termination of X. Xxxxx'x rights under this
Agreement pursuant to this Section 16.2, (x) neither Party
shall be relieved of any obligations incurred prior to
such termination or thereafter in the country or countries
specified in this Agreement not subject to such
termination, (y) X. Xxxxx'x rights under this Agreement
will terminate in such country or countries according to
the notice, opportunity to cure and other procedures
specified for general termination of this Agreement under
this Section 16 and (z) such rights will revert to GTC.
c. GTC Willful Breach or Gross Negligence. Notwithstanding
anything contained in this Section 16 to the contrary, if,
following the filing of the first BLA by either of the
Parties under this Agreement, GTC has willfully breached
this Agreement or has been grossly negligent in its
performance of its obligations hereunder, and GTC has not
corrected such breach within three (3) months of X.
Xxxxx'x written request (which three (3) month period may
be extended by agreement of the Parties, if GTC is
diligently attempting to correct such breach), then X.
Xxxxx may, at its sole option and without prejudice to any
other remedy it may have, produce itself or have produced
all or any part
32
of its requirements for Bulk rh[*] for use in the Product,
utilizing the GTC Patent Rights, the Project Patent
Rights, the GTC Technology and the Project Technology.
GTC, at its own cost and expense, promptly shall transfer
to X. Xxxxx the non-exclusive right to use the GTC Patent
Rights, Project Patent Rights, GTC Technology and Project
Technology to make and have made the Bulk rh[*] for use in
the Product. In addition, GTC, at its own cost and
expense, will provide X. Xxxxx with reasonable production
assistance, so that X. Xxxxx may use the GTC Patent
Rights, Project Patent Rights, GTC Technology and Project
technology to produce Bulk rh[*] for such purpose. In the
event X. Xxxxx elects to produce or have a third party
produce Bulk rh[*] for such purpose, X. Xxxxx shall pay
GTC a fee equal to fifty percent (50%) of the royalty
rates set forth in Section 11.6(b), above, on X. Xxxxx'x
sales of Product filled and finished from Bulk rh[*]
produced by X. Xxxxx under this Subsection (c).
16.3. Termination by X. Xxxxx. In addition, X. Xxxxx may terminate
this Agreement, or its rights and obligations in a country or
countries under this Agreement, as specified below:
a. In the event GTC is acquired by a major competitor of X.
Xxxxx, X. Xxxxx shall be entitled to terminate this
Agreement by giving not less than ninety (90) days prior
written notice to GTC.
x. X. Xxxxx may terminate its rights and obligations under
this Agreement with respect to any country at any time by
giving not less than ninety (90) days prior written notice
to GTC if, due to any governmental or regulatory action in
such country or countries, X. Xxxxx is unable to market
the Product in such country; in such event, all rights to
manufacture, import, market, sell and use the Product in
such country or countries shall revert to GTC.
x. X. Xxxxx may terminate this Agreement at any time by
giving not less than ninety (90) days prior written notice
to GTC if X. Xxxxx determines that it does not desire that
development and/or commercialization of the rh[*] and/or
the Product shall be continued; provided, however, in such
event X. Xxxxx shall pay GTC for all reasonable costs and
obligations incurred by GTC (with the Liaison's
Committee's consent) under this Agreement through the date
of such termination. Thereafter, all of X. Xxxxx'x rights
under this Agreement shall revert to GTC, except that X.
Xxxxx shall retain the rights set forth in Section 14.1,
above.
x. X. Xxxxx may terminate this Agreement by giving not less
than ninety (90) days prior written notice to GTC if a
development milestone as set forth in Section 4.7 and
Schedule C of this Agreement is not met within ninety (90)
days of the date specified for completion of such
milestone; X. Xxxxx also may terminate its rights and
obligations with respect to [*] only, by giving not less
than ninety (90) days prior written notice to GTC, if a
development milestone as set forth in Section 8.3 and
Schedule C of this Agreement is not met within one ninety
33
*Confidential Treatment has been requested for the marked portion.
(90) days of the date specified for completion of such
milestone; provided, however, GTC shall have the
opportunity during such ninety-day notice period to meet
such milestone, in which case this Agreement may not be
terminated. In the event of termination by X. Xxxxx under
his Subsection (d), X. Xxxxx shall pay GTC for all
reasonable costs and obligations incurred by GTC with the
Liaison Committee's consent) under this Agreement through
the date of such termination.
16.4. Termination by Either Party. Either Party may terminate this
Agreement in the event the other Party shall enter into
liquidation or become insolvent or have a receiver appointed with
respect to any of its assets or takes or suffers any other
similar or equivalent action by reason of insolvency or in
consequence of debt, such termination to be effective immediately
upon written notice to such other Party.
16.5. Effect of Termination.
a. In the event X. Xxxxx terminates this Agreement, other
than pursuant to breach by GTC under Section 16.2 or for
the reasons set forth in Sections 16.3(a) or (d) or 16.4,
above, then for a period of four (4) years following such
termination, X. Xxxxx shall first offer GTC the
opportunity to supply X. Xxxxx with all if its
requirements, if any, of bulk-form recombinant human [*]
(or any modification or formulation thereof), on
commercially reasonable and competitive terms and
conditions to be agreed to by the Parties.
b. Termination of this Agreement shall not affect the rights
and obligations of the Parties accrued under this
Agreement prior to such termination and, other than as
specified in Section 16.3, X. Xxxxx shall be obligated to
make milestone payments under Sections 4.7 and 8.3 in the
event of completion of such milestones prior to
termination of the Agreement.
x. X. Xxxxx shall have the right to sell its remaining
inventory of Product under the obligation to pay to GTC
the running royalties due thereon.
d. In the event GTC terminates this Agreement as provided for
herein or Xxxxx terminates this Agreement other than
pursuant to Sections 16.2, 16.3(d) or 16.4, above, or
terminates its rights and obligations with respect to any
country or countries under this Agreement, X. Xxxxx shall
cancel all rights of regulatory approvals with the health
authorities for the Product, if any, in the Territory or
in such country or countries, as applicable, or upon GTC's
request, transfer the same to GTC or an entity to be named
by GTC, with the costs of such transfer being borne by
GTC.
e. Following termination, each Party shall be free to
non-exclusively use its interest in the Project Patent
Rights and Project Technology without restriction or
obligation to the other Party; provided, however, the
restrictions set forth in Section 14.1 shall be applicable
analogously (other than in the event of termination
pursuant to Sections 16.2, 16.3(d) or 16.4, above) and
shall survive
34
*Confidential Treatment has been requested for the marked portion.
any such termination, as provided for therein.
16.6. Survival of Obligations; Return of Confidential Information.
Notwithstanding any termination or expiration of this Agreement,
the obligations of the Parties under Sections 6.2, 12, 14, 15, 16
and 17 of this Agreement shall survive and continue to be
enforceable. Upon any termination of this Agreement, each Party
shall promptly return to the other Party all written Confidential
Information, and all copies thereof, of the other Party, but may
retain one (1) copy for archival purposes.
17. Miscellaneous.
17.1. Public Announcements. Neither Party shall make any public
disclosure regarding this Agreement without the prior written
consent of the other Party. Each Party hereby covenants and
agrees to collaborate with the other Party within reason
concerning disclosures which are or may be expected to be
publicly disseminated regarding the existence of this Agreement.
Notwithstanding the foregoing, neither Party shall be required to
obtain the consent of the other Party regarding a disclosure of
this Agreement for purposes of disclosures which such Party
reasonably believes to be required by law; provided, however,
that the Party intending to disclose such Confidential
Information provides advance written notice to the other Party,
and that such disclosing party takes all reasonable and lawful
actions to obtain confidential treatment for such disclosure and,
if possible, to minimize the extent of such disclosure.
17.2. Good Faith Effort to Resolve Disputes. Any controversy or claim
arising out of, or relating to, any provisions of this Agreement,
or breach thereto, shall be referred for resolution to GTC's
president, and to X. Xxxxx'x president ("Vorstandsvorsitzender").
If the Parties respective officers, or their designees cannot
reach a resolution of the dispute within sixty (60) days after
referring such dispute to the Parties respective presidents, then
the dispute shall be resolved by binding arbitration pursuant to
the provisions of Section 17.3.
17.3. Arbitration. Any dispute arising between the Parties in
connection with this Agreement which cannot be resolved pursuant
to the provisions of Section 17.2 shall be finally settled under
the rules of the International Chamber of Commerce ("ICC"), by a
panel of three (3) arbitrators, one of such arbitrators to be
selected by GTC, one of such arbitrators to be selected by X.
Xxxxx, and a third to be selected by the other two. Both legal
and equitable remedies shall be available to the arbitrators.
Judgment upon the award rendered by the arbitrators may be
entered in any court having jurisdiction thereof. Any such
arbitration shall be held in Boston, Massachusetts, for
arbitration proceedings commenced by X. Xxxxx, and in
Frankfurt/Main, Germany, for arbitration proceedings commenced by
GTC, or at such other location as the Parties may agree, and
shall be conducted in the English language. The losing Party
shall bear all costs of the arbitration. If one Party fails to
select an arbitrator within sixty (30) days after receiving
notice of arbitration from the other Party, then such Party shall
forfeit its right to select an arbitrator, and such arbitrator
shall be selected by the ICC.
35
17.4. Successors and Assigns. The provisions of this Agreement shall
be binding upon, and inure to the benefit of, the respective
successors and assigns of the Parties hereto.
17.5. Notices. Any notice or other communication in connection with
this Agreement must be in writing and if by mail, by registered
mail, return receipt requested, and if transmitted by telecopier,
with a copy sent by mail in accordance with this Section 17.5,
and shall be effective when delivered to the addressee at the
address or telecopier number listed below or such other address
or telecopier number as the addressee shall have specified in a
notice actually received by the addressor.
If to X. Xxxxx: X. Xxxxx Melsungen XX
Xxxx-Xxxxx-Xxxxxxx 0
00000 Xxxxxxxxx / Xxxxxxx
Telecopier: 49/5661/71-3569
Attn: Head of the Pharma Division
If to GTC: Genzyme Transgenics Corporation
Xxxx Xxxxxxxx Xxxx
Xxxxxxxxxx, Xxxxxxxxxxxxx 00000 XXX
Telecopier: 000-000-0000
Attn: Vice President and General Counsel
17.6. Export. The Parties acknowledge that the export of technical
data, materials or products may be subject to the exporting Party
receiving the necessary export licenses. The Parties agree that
regardless of any disclosure made by the Parties receiving an
export of an ultimate destination of any technical data,
materials or products, the receiving Party will not reexport
either directly or indirectly, any technical data, material or
products without first obtaining the applicable validated or
general license from the United States Department of Commerce,
United States Food and Drug Administration and/or any other
agency or department of the United States Government, as
required. The receiving Party shall provide the exporting Party
with any information, certifications or other documents which may
be reasonably required in connection with such exports under the
Export Administration Act of 1979, as amended, its rules and
regulations, the Federal Food, Drug and Cosmetic Act and other
applicable export laws.
17.7. Foreign Corrupt Practices Prohibited. In carrying out its
responsibilities under this Agreement, X. Xxxxx will not pay or
agree to pay, directly or indirectly, any funds or anything of
value to any public official in a foreign country or jurisdiction
within the Territory for the purpose of influencing such
official's official acts or decisions. If X. Xxxxx directly or
indirectly offers, pays, promises, gives or authorizes payment of
any money or anything of value to any government or public
official for the purpose of influencing any official in the
course of carrying out this Agreement, this Agreement will
automatically terminate. X. Xxxxx agrees to notify GTC of any
request that X. Xxxxx receives to take any action that might
constitute a violation of the United States Foreign Corrupt
Practices Act of 1977, as amended.
36
17.8. Entire Agreement. This Agreement embodies the entire agreement
and understanding between the Parties with respect to the subject
matter hereof and supersedes all prior agreements and
understandings relating to such subject matter.
17.9. Waiver. Except as otherwise expressly set forth in this
Agreement, any term of this Agreement may be amended and the
observance of any term of this Agreement may be waived (either
generally or in a particular instance and either retroactively or
prospectively), only with the written consent of the Parties. No
waivers or exceptions to any term, condition or provision of this
Agreement, in any one or more instances, shall be deemed to be,
or construed as, a further or continuing waiver of any such term,
condition or provision.
17.10. Counterparts. This Agreement may be executed in several
counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument.
17.11. Headings. The headings of the sections, subsections, and
paragraphs of this Agreement have been added for convenience only
and shall not be deemed to be a part of this Agreement.
17.12. Force Majeure. Either Party's failure to perform any term or
provision of this Agreement shall be considered an "Excused
Failure" if caused by any reason beyond its reasonable control
(not including, however, financial difficulties), or by reason of
any of the following circumstances: the development of rh[*] or
the manufacture or marketing of the Product is disallowed or
restrained by any statute, rule or regulation or a binding
judgment, order or decree of any court or administrative agency,
or denial of a necessary governmental approval; and to the extent
that any one or more of the following conditions actually disable
the development of rh[*] or the manufacture or marketing of the
Product, labor disturbances or labor disputes of any kind;
accident; disease; failure of utilities, mechanical breakdowns,
material shortages or other similar occurrences; civil disorders
or commotions, acts of aggression, vandalism or other similar
occurrences; or fire, floods, earthquakes, or acts of God.
Neither Party shall be responsible in damages or otherwise for
any delay in the performance of its obligations hereunder (other
than obligations to pay money) caused by any even or occurrence
considered an Excused Failure; and each Party agrees to give
notice of each such delay to the other Party within ten (10)
business days of its inception, together with an estimate of the
length of the delay, and agrees to continue to make all
reasonable efforts to perform its obligations hereunder both
during and after the period of such delay.
17.13. Severability. In the event that any provision of this Agreement
is held by a court of competent jurisdiction to be unenforceable
because it is invalid or in conflict with any law of any relevant
jurisdiction, such provision shall be deemed not to have taken
effect from the date of this Agreement and the validity of the
remaining provisions shall not be affected, and the rights and
obligations of the Parties shall be construed and enforced as if
the Agreement
37
*Confidential Treatment has been requested for the marked portion.
did not contain the particular provision held to be
unenforceable, and the Parties shall negotiate in good faith with
each other and with such court with a view to modifying this
Agreement in a manner which as closely as is reasonably
practicable reflects the commercial objectives and effect of this
Agreement as originally signed.
17.14. Assignment. Neither this Agreement nor any of the rights or
obligations hereunder may be assigned or transferred, in whole or
in part, by either Party, without the prior written consent of
the other Party, except that (a) either Party may assign this
Agreement in whole or in part to an Affiliate, provided that such
Party remains primarily liable and/or responsible for the
performance of such obligations, and provided further that such
Affiliate agrees to be bound to the terms and conditions of this
Agreement, (b) either Party may assign and transfer this
Agreement in connection with the merger, consolidation or sale of
all or substantially all of that Party's assets (other than by
GTC to a major competitor of X. Xxxxx, as provided in Section
16.3(a)), (c) X. Xxxxx may assign this Agreement, without GTC's
prior consent, in the event GTC is acquired by a third party
which is not an Affiliate and (d) X. Xxxxx may assign this
Agreement, with GTC's prior consent, following approval of a BLA
for the Product in a country in the Territory.
17.15. Governing Law. This Agreement shall be exclusively governed by
and construed in accordance with the Laws of Switzerland, without
regard to conflicts of laws principles dictating the application
of the law of another jurisdiction. The Parties expressly reject
any application of the United Nations Convention on Contracts for
the International Sale of Goods.
17.16. Waiver of Immunity. To the extent that either Party may in any
jurisdiction in which proceedings may at any time be taken for
the enforcement of this Agreement claim for itself or its assets
immunity from suit, judgment, execution, attachment (whether in
aid of execution, before judgment or otherwise) or other legal
process, the Parties hereby irrevocably waive any such immunity
to the fullest extent now or hereafter permitted by the law of
such jurisdiction.
17.17. Equitable Remedies. Each Party acknowledges that in certain
cases (as determined by the courts of competent jurisdiction) of
a violation by either Party of any of the provisions of this
Agreement may entitle the other Party to equitable relief in
addition to any other right or remedy, and this relief shall be
available in addition to, and shall not be unavailable by reason
of, the arbitration provisions of Section 17.3 hereof. Such
equitable relief may be in the way of temporary restraining
orders, and preliminary and permanent injunctions, and such other
equitable relief as any court of competent jurisdiction may deem
just and proper.
17.18. Consents Not Unreasonably Withheld. Whenever a provision is made
in this Agreement which requires either Party to secure the
consent or approval of the other, such consent or approval shall
not be unreasonably withheld, and whenever in this Agreement
provisions allow for one Party to object or to disapprove a
matter, such
38
objection or disapproval shall not be unreasonably exercised.
17.19. Compliance with Laws. The Parties shall comply with all material
laws, regulations and other requirements with regard to the
performance of its obligations under this Agreement. If any law
or regulation in the Territory or any subdivision thereof
requires that any governmental agency receive notice of or
registration of this Agreement, X. Xxxxx and GTC shall cooperate
in the preparation of such registration or notification.
Duly authorized representatives of the parties have signed this Agreement
as of the Effective Date.
GENZYME TRANSGENICS CORPORATION
By /s/ Xxxxx X. Xxxxxxxx By /s/ Xxxxxxx Xxxxx
------------------------------ ------------------------------
Print Name: Xxxxx X. Xxxxxxxx Print Name: Xxxxxxx Xxxxx
Title President and CEO Title Vice President
--------------------------- ---------------------------
duly authorized duly authorized
B XXXXX MELSUNGEN AG
By /s/ Xxxxxxxx Xxxxxx By /s/ Xxxxx Xxxxx
------------------------------ ------------------------------
Print Name Xxxxxxxx Xxxxxx Print Name: Xxxxx Xxxxx
Title Member of the Board Title: Member of the Board
--------------------------- ---------------------------
duly authorized duly authorized
Enclosures
39
Schedule A
Specifications
The Specifications for Bulk rh[*] will be developed and attached to this
Agreement as an integral part thereof by the Parties, via the Liaison
Committee. Preliminary Specifications will be established and agreed upon by
the Liaison Committee within ninety (90) days of the Effective Date.
Additionally, a detailed development plan will be established and adopted by
the Liaison Committee within such 90-day period. The Specifications shall
include the Acceptance Assays and related information, as set forth in the
Agreement. The parameters of the Specifications shall include, without
limitation, specifications for Bulk rh[*] purity, activity, amino acid
sequence information, that the Bulk rh[*] (and Product filled and finished
therefrom) shall be essentially similar to the leading non-transgenic
recombinant human [*] produced in cell culture as of the Effective Date of
this Agreement, anticipated dosing information, the profile of the leading
non-transgenic recombinant human [*]produced in cell culture as of the
Effective Date of this Agreement which has been accepted by Regulatory
Authorities, product quality appropriate for its use in the intended
indications, quality control provisions, cost parameters, and any other
parameters agreed to by the Parties.
40
*Confidential Treatment has been requested for the marked portion.
Schedule B
GTC Patent Rights
[*]
41
*Confidential Treatment has been requested for the marked portion.
Schedule C
GTC Development Plan
[*]
42
*Confidential Treatment has been requested for the marked portion.
