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EXHIBIT 10.22
CONFIDENTIAL TREATMENT
REQUESTED = [*] CERTAIN
CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, IS FILED
WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
LONG TERM SUPPLY AGREEMENT
THIS Agreement is entered into effective as of 28 September 1995,
between COR Therapeutics, Inc. ("COR"), a Delaware corporation, with its
principal offices at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇
▇▇▇▇▇, and Solvay, Societe Anonyme ("Solvay"), a Belgian corporation, with its
principal offices at ▇▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ - ▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, each on
behalf of itself and its Affiliates. COR and Solvay are sometimes referred to
herein individually as a "Party" and collectively as the "Parties", and
references to "COR" and "Solvay" shall include their respective Affiliates.
WHEREAS:
COR and Solvay are Parties to a certain License and Supply
Agreement dated 27 July 1994 (the "License Agreement") and a Supply Agreement
dated 27 July 1994 (the "Supply Agreement"); and
COR and Solvay wish to enter into a further agreement for the
long term production and supply of bulk peptide products containing
Integrelin(TM).
NOW, THEREFORE, COR and Solvay agree as follows:
1.0 CERTAIN DEFINITIONS.
1.1 "AFFILIATES" shall mean any entity or person which controls,
is controlled by or is under common control with either Party. For purposes of
this Article 1.1, "control" shall mean (a) in the case of corporate entities,
the direct or indirect ownership of at least one-half of the stock or
participating shares entitled to vote for the election of directors, and (b) in
the case of a partnership, the power to direct the management and policies of
such partnership. Without limitation of the foregoing and for purposes of this
Agreement, Peptisyntha & Cie, Societe en Nom Collectif ("Peptisyntha"), which is
fully owned subsidiary of Solvay and an entity existing under the laws of
Belgium and having its principal offices at ▇▇▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ - ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, and also Solvay Duphar B.V., a Dutch corporation having its
main office at ▇.▇. van ▇▇▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, are deemed
Affiliates of Solvay.
1.2 "BULK PRODUCT" shall mean a bulk peptide product which
contains Integrelin(TM), is produced by the Licensed Process (as defined in the
License Agreement) and is intended to undergo further processing, formulation
and/or vialing and packaging.
1.3 "BULK PRODUCT INTERMEDIATES" shall mean [*] used to
manufacture Bulk Product which have been partially processed.
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1.4 "INTEGRELIN(TM)" shall mean a specific peptide designated by
COR and known as Integrelin(TM), the chemical structure of which is known to
Solvay because of the prior business relationship between COR and Solvay.
1.5 "KEY RAW MATERIALS" shall mean [*] reasonably required for
the production of Bulk Product [*].
1.6 "PRODUCTION CAPACITY" shall refer to Solvay's capacity for
manufacturing Bulk Product during a given period of time, considering the
available plant, equipment, personnel and other staff and physical assets.
Production Capacity shall be measured in [*] of Bulk Product per year.
1.7 "PRODUCTION FORECASTS" shall mean the estimates of future
requirements for Bulk Product to be manufactured by Solvay that are prepared by
COR pursuant to Article 3.2.
1.8 "PRODUCTION SUITE" shall mean the plant, equipment, and
other physical assets of Solvay sufficient for the manufacture of an annual unit
amount [*] of Bulk Product through a complete production cycle. A complete
production cycle is considered to start with [*] and end with [*]. A Production
Suite shall be considered "New" until, for the first two New Production Suites,
the [*] and for additional New Production Suites, the end of the [*] following a
request by COR, duly accepted by Solvay, for the establishment of such New
Production Suite pursuant to Article 2.3.
1.9 "PURCHASE ORDER" shall mean a binding order placed by COR
for the production and supply by Solvay of Bulk Product.
1.10 "SPECIFICATION" shall mean the specification for Bulk
Product as agreed to by the Parties and as may thereafter be amended in writing
from time to time by mutual consent to reflect changes in such specifications.
The current Specification is contained in Appendix D.
Unless otherwise defined herein, other capitalized terms used
herein shall have the meaning specified in the License or Supply Agreement. For
convenience, this Agreement may refer to specific provisions or appendices of
the License or the Supply Agreement. Defined terms may be used in their singular
or plural forms.
2.0 ESTABLISHMENT AND RESERVATION OF PRODUCTION CAPACITY.
2.1 INITIAL PRODUCTION CAPACITY. The parties agree that,
pursuant to Section 2.2 of the Supply Agreement, COR has ordered and Solvay has
agreed to supply the [*] of Bulk Product for delivery in 1997, and that COR
shall pay to Solvay [*] of the purchase price for that order within [*] days of
the execution of this Agreement. Solvay represents and COR acknowledges that for
1997, Solvay's Production Capacity will be [*] per year pursuant to this
Agreement, in addition to the capacity required to manufacture the quantity of
Bulk Product already ordered for delivery in 1997 pursuant to the Supply
Agreement.
2.2 PRODUCTION CAPACITY INCREASE. Solvay represents and COR
acknowledges that decisions regarding the establishment of any New Production
Suite(s) will
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need to be made approximately [*] before the [*] in which COR would like to have
the New Production Suite(s) established to allow time for construction and
validation. Therefore, on a timely basis, the Parties shall discuss the
Production Forecasts and the implication of these forecasts on the need for New
Production Suites.
2.3 TIMING OF NEW PRODUCTION CAPACITY COMMITMENTS. Solvay shall
establish [*] New Production Suites before the beginning of 1998 and shall be
able to complete production of Bulk Product in those suites [*]. On [*] and on
[*] during the term of this Agreement, COR may request that Solvay establish
additional New Production Suites capable of complete production of Bulk Product
therein [*] following the request. Within [*] from each [*] when such request
has been made, Solvay shall notify COR whether or not it will establish part or
all of the requested New Production Suites.
2.4 FEE FOR FACILITATION OF NEW PRODUCTION SUITES. In order to
facilitate the establishment by Solvay of New Production Suites, COR shall pay
to Solvay a fee intended to be applicable to the future manufacture of Bulk
Product in the amount of [*] for [*] New Production Suites, and [*] for [*] New
Production Suite whose establishment is agreed upon by Solvay and COR. For each
New Production Suite, such fee payments shall be made in [*] installments:
(a) [*] for the [*] New Production Suites, and for [*]
New Production Suite, within [*] from the receipt by COR of notice by Solvay
that it will establish such additional New Production Suite;
(b) [*] within [*] from delivery of the major equipment
for each New Production Suite, as certified by Solvay; and
(c) [*] within [*] from validation of each New
Production Suite in accordance with Good Manufacturing Practice requirements as
prescribed from time to time by appropriate regulatory agencies, as certified by
Solvay and agreed by COR. In the event COR does not agree with Solvay's
certification of validation, and provided that COR so notifies Solvay within [*]
of COR's receipt of Solvay's certification, COR shall pay to Solvay the [*]
installment subject to return of such installment on demand forthwith in the
event that an independent auditor, agreeable to both COR and Solvay, find that
the facility is not appropriately validated.
2.5 CREDIT FOR FEE PAYMENT. The fee payments made to Solvay
pursuant to Article 2.4 coincident with the establishment of a New Production
Suite shall be credited against future installment payments made pursuant to
Article 8.3(d) for Bulk Product in an amount equal to (i) [*] of the total
purchase price of quantities of Bulk Product produced in the New Production
Suite up to the first [*] per calendar year, and (ii) [*] of the total purchase
price of quantities of Bulk Product produced in the New Production Suite over
[*] per calendar year, until this Agreement is terminated. The fee payments made
to Solvay pursuant to Article 2.4 coincident with the establishment of a New
Production Suite shall not be refundable to COR except in the event of a
material breach by Solvay of its obligations under this Agreement to establish
that particular New Production Suite.
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2.6 RESERVATION OF PRODUCTION CAPACITY. Solvay shall reserve a
Production Capacity of [*] for 1997, in addition to the capacity required to
manufacture the quantity of Bulk Product already ordered for [*]. For 1998,
Solvay shall reserve a Production Capacity of [*] per year. For 1999 and
subsequent years, Solvay shall reserve a Production capacity equal to [*] (a)
the quantity of Bulk Product ordered for manufacture in the previous year [*] or
(b) [*] Production Capacity of all New Production Suite(s). In the event that
the reserved Production Capacity for 1999 or subsequent years is [*], Solvay may
utilize the unreserved capacity for manufacturing activities unrelated to this
Agreement, so long as such activities do not adversely effect the ability of
Solvay to produce Bulk Product in the amounts ordered by COR or the regulatory
status of Integrelin(TM).
3.0 PRODUCTION PLANNING AND FORECASTS.
3.1 PRODUCTION SCHEME. Solvay represents and COR acknowledges
that certain manufacturing steps (described in terms of their timing and yields)
are to be utilized by Solvay in the production of Bulk Product from Bulk Product
Intermediates and certain Bulk Product Intermediates from other Bulk Product
Intermediates or from raw materials at various levels of production. This
production scheme is set forth in Appendix A. Solvay shall provide COR with a
prompt written update of this production scheme whenever the information
provided in Appendix A differs substantially from actual performance.
3.2 PRODUCTION FORECASTS. COR shall provide Solvay with
forecasts of its expected requirements for Bulk Product in accordance with
Section 2.2 of the License Agreement that are prepared in good faith and to the
best of COR's knowledge at the time they are prepared. The Production Forecasts
shall be consistent with the forecasts made by COR for requirements for
Integrelin(TM) worldwide, including [*]. The first Production Forecast is
appended hereto as Appendix B. Subsequent Production Forecasts shall be provided
to Solvay on [*] of each year during the term of this Agreement, but COR may
elect to provide such Production Forecasts more frequently. The Production
Forecasts are provided for the purpose of programming, are not to be construed
as Purchase Orders, and are not binding on COR or Solvay.
3.3 CHANGES TO THE SPECIFICATION. In the event that COR notifies
Solvay of requested changes to the Specification, Solvay shall acknowledge
receipt of such notice within a reasonable time, but in any event no later than
[*]. The Specification shall not be changed without the agreement of both
Parties. To the extent that changes to the Specification accomplish a change in
Production Capacity, Solvay shall so notify COR, and any increases in Production
Capacity created in this fashion shall not require any additional payment by COR
under Article 2.4. Both parties acknowledge that such changes may have an effect
on Appendices A and C.
4.0 PURCHASE ORDERS.
4.1 PURCHASE COMMITMENT. COR agrees to purchase and Solvay
agrees to manufacture and supply an amount of Bulk Product through Purchase
Orders to Solvay. Any Purchase Orders placed under this Agreement do not replace
or supersede the quantities of Bulk Product specified for purchase by COR in
Section 2.2 of the Supply Agreement.
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4.2 ADDITIONAL PURCHASE COMMITMENT. COR shall order from Solvay
a minimum quantity of [*] of Bulk Product to be manufactured in the calendar
years [*]. In the event that COR does not order [*] of Bulk Product for any such
calendar year, COR shall pay a capacity reservation fee for such [*] calculated
as follows: [*]. Such capacity reservation fee shall be paid in [*]
installments, within [*] days of the end of each calendar quarter during the
affected year. The capacity reservation fee may be satisfied (i) in cash or (ii)
by the value of other research, development or manufacturing contracts placed
with Solvay in the field of [*] by COR or by third parties whose arrangements
with Solvay are facilitated by COR, or (iii) a combination of (i) and (ii).
4.3 TIMING OF PURCHASE ORDERS. On [*], COR shall provide Solvay
with a Purchase Order specifying the amount of Bulk Product that COR is ordering
for calendar year 1997. On [*] and on each anniversary thereof during the term
of this Agreement, COR shall provide Solvay with a Purchase Order specifying the
amount of Bulk Product that COR is ordering for the following calendar year.
Solvay shall accept such Purchase Orders as long as the amount ordered does not
exceed the Production Capacity reserved for COR pursuant to Article 2.6 for such
year. Further, COR may elect to increase the amount COR has ordered for a
calendar year by providing Solvay with a supplemental Purchase Order no later
than [*] of the relevant ordering year, which increase Solvay shall accept, as
long as the total amount does not exceed either the Production Capacity reserved
for COR pursuant to Article 2.6 for such year or [*] of the amount of the
Purchase Order placed on [*] for such year.
4.4 SIZE OF ORDERS. For [*] and any subsequent calendar year
during the term of this Agreement, an order for Bulk Product shall be at least
equal to [*] and the total amount of Bulk Product ordered by COR shall not
exceed [*] or [*] of the amount of the Purchase Order placed on [*] for such
year. However, COR may request that Solvay produce [*] and Solvay agrees to use
reasonable efforts to accommodate such request. [*] Solvay shall be entitled to
utilize for manufacturing activities unrelated to this Agreement any unused
Production Capacity as long as such activities do not affect the ability of
Solvay to produce Bulk Product in the quantities ordered by COR or the
regulatory status of Integrelin(TM).
4.5 ACCEPTANCE OF PURCHASE ORDERS. Solvay shall acknowledge in
writing its receipt of and acceptance of a Purchase Order or increased Purchase
Order placed pursuant to this Article within [*] of receipt.
4.6 PRODUCTION SCHEDULING. During the term of this Agreement,
COR may request that Solvay modify the production schedule pertaining to an
outstanding Purchase Order by [*] or more steps of the production scheme of
Appendix A, subject only to the payment to Solvay of a price adjustment
described in Article 4.8, provided that such [*] of the production schedule [*]
does not result in orders for Bulk Product manufacture for that [*] which exceed
the Production Capacity reserved for COR pursuant to Article 2.6. Bulk Product
manufactured only through [*] shall be put into inventory by Solvay pursuant to
Article 5.2, however Solvay represents and COR acknowledges that Bulk Product
manufactured only through [*] of the manufacturing steps in Appendix A and put
into inventory pursuant to this Article 4.6 cannot be kept in inventory for a
period exceeding [*].
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4.7 PRODUCTION CAPACITY REALLOCATION. For 1998 and each
subsequent calendar year, COR may request that Solvay reallocate the use of the
Production Capacity planned by Solvay for Bulk Product manufacture in that year
by rearranging the production schedule pursuant to Article 4.6, according to the
production scheme of Appendix A, subject to the agreement of Solvay which shall
not be unreasonably withheld, provided that the Production Capacity is used [*].
4.8 PRODUCTION POSTPONEMENT AND ORDER CANCELLATION BY COR. Any
[*] pursuant to Article 4.6 shall be subject to the [*]. For Purchase Orders
placed in a given year, such [*] for Purchase Orders [*] of the given year, [*]
for Purchase Orders [*] of the given year, [*] for Purchase Orders [*] of the
following year, [*] for Purchase Orders [*] of the following year, or [*] for
Purchase Orders [*] of the following year. Following a modification of the
production scheme pursuant to Article 4.6, COR may elect to cancel, by notice
given to Solvay within [*] of any such modification, an outstanding Purchase
Order for Bulk Product manufactured only through [*] and retained in inventory
without paying any [*]. After such cancellation, Solvay shall [*] and provide
COR certification [*].
5.0 INVENTORIES, STORAGE AND OWNERSHIP OF RAW MATERIALS AND BULK
PRODUCT INTERMEDIATES.
5.1 RAW MATERIALS INVENTORY. In addition to having available the
amounts of Key Raw Materials required to accomplish the manufacture of the
specific quantities of Bulk Products or Bulk Product Intermediates ordered by
COR for each calendar year during the term of this Agreement, Solvay will
maintain an inventory of Key Raw Materials of not less than the amount necessary
to meet [*] of the production scheduled for that calendar year. The inventory
will be maintained at a facility [*] Such inventory shall be rotated [*].
5.2 INVENTORY OF BULK PRODUCT INTERMEDIATES. During the term of
this Agreement, Solvay will maintain in inventory Bulk Product Intermediates
manufactured up through certain manufacturing steps, as defined in Appendix A,
pursuant to Articles 4.6, 4.7 or 4.8. To the extent possible, such inventory
shall be rotated on a [*] basis, with Bulk Product Intermediates subsequently
manufactured and scheduled for production through to final Bulk Product. Solvay
shall retain samples of lots of each Bulk Product Intermediate to be used in the
manufacture of Bulk Product until such Bulk Product ha been manufactured,
shipped to and accepted by COR.
5.3 BULK PRODUCT INVENTORY. During the term of this Agreement,
Solvay shall notify COR of the completion of the manufacture of each lot of
final, [*] Bulk Product and shall put such lot into inventory at a facility [*]
and for a period not to exceed [*]. Solvay shall deliver all completed Bulk
Product to its inventory facility, and shipments shall be delivered to COR from
that inventory facility.
5.4 STORAGE COST. No separate storage or inventorying costs
pursuant to Solvay's obligations under this Article shall be charged to COR.
5.5 OWNERSHIP. Upon full payment by COR for Bulk Product
pursuant to Article 8.3, COR shall own such Bulk Product. Upon payment by COR
for completion of Bulk
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Product through a particular manufacturing step pursuant to Article 8.0, COR
shall also own those materials and shall be entitled to take possession of them
in the event of material breach of this Agreement by Solvay, or in the event
that Solvay indicates that it will not be able to deliver Bulk Product within
[*] of an agreed shipping date, and such possession shall be COR's only remedy
with respect to these materials in such events.
6.0 QUALITY CONTROL AND REGULATORY MATTERS.
6.1 SOLVAY'S MANUFACTURING COMMITMENT. Solvay shall manufacture
Bulk Product under this Agreement in conformity with the Specification, in a
duly licensed facility as required by the United States Food and Drug
Administration and equivalent European Union regulatory agencies, and in
compliance with applicable laws and regulations and Good Manufacturing
Practices, as prescribed from time to time by these appropriate regulatory
agencies. Each shipment of Bulk Product hereunder shall have been subjected to a
quality control inspection by Solvay in accordance with the Specification and
with Solvay's then-current quality control standards and systems, which shall be
consistent with those agreed between COR and Solvay. Solvay shall number each
shipment with a vendor lot number that is traceable to Key Raw Materials, Bulk
Product Intermediates and/or other components used to manufacture such Bulk
Product and shall maintain all appropriate validation documentation as
reasonably specified by COR and agreed by Solvay, or as required by appropriate
regulatory authorities. Such manufacturing and validation information shall be
communicated to COR pursuant to Section 3.4 of the License Agreement. Solvay
shall permit COR and/or representatives of appropriate regulatory agencies to
review periodically Solvay's Bulk Product manufacturing facilities and testing
procedures at reasonable times with a Solvay representative present, and to
obtain copies of batch records for Bulk Product in order to assure compliance
with the requirements of this Article 6.0.
6.2 COMPLIANCE WITH LAW. Solvay shall be responsible for
complying with all applicable regulatory requirements of the United States, the
European Union, and to the extent applicable, of Member States of the European
Union, for the manufacture, importation and shipment of the Bulk Product
supplied hereunder. Solvay shall give COR prompt written notice of any impending
inspections by a governmental agency of the facility used for or processes
involved in the manufacture of Bulk Product, and provide COR an opportunity to
observe such inspection. Each Party shall promptly notify the other in writing
of new instructions or specifications of which it becomes aware and governmental
inspection reports which are relevant to the manufacture of Bulk Product under
this Agreement and which are required by the United States Food and Drug
Administration, equivalent European Union regulatory agencies, or other
applicable laws or governmental regulations and shall confer with each other
with respect to the best means to comply with such requirements. Solvay shall
assist COR in obtaining and maintaining all approvals and authorizations of any
governmental agencies necessary for the use, sale or distribution of
Integrelin(TM) products, and will notify COR within [*] of any comments,
responses or notices received from any governmental authorities which relate to
the regulatory status of Integrelin(TM). These actions by Solvay shall not be
construed as an admission that Solvay is doing business in the United States.
6.3 NOTIFICATION OF ISSUES. Solvay shall notify COR in writing
within [*] of any issue related to manufacturing or raw material supply, or
other information relating to
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Solvay or the site of manufacture which may affect the regulatory status of
Integrelin(TM) or the ability of Solvay to supply Bulk Product.
7.0 SHIPPING AND ACCEPTANCE OF PRODUCT.
7.1 SHIPPING INSTRUCTIONS. COR shall send to Solvay a request
for shipment of Bulk Product at least [*] prior to a requested date of delivery,
the exact date of delivery to be agreed between COR and Solvay. Solvay shall
acknowledge in writing its receipt of and acceptance of a shipping request
within [*] of receipt and shall use its best efforts to:
(a) ship Bulk Product at the agreed delivery date with
the proper identification on the packaging as required by applicable
authorities; and
(b) fill the entirety of each shipping request from the
same production lot.
7.2 PRODUCT SHIPPING PROCEDURES. Solvay shall ship to a
destination specified by COR all Bulk Product owned by COR pursuant to Article
5.5 and requested to be delivered, by the delivery dates provided in an accepted
shipping request. Bulk Product will be labeled and packaged according to the
Specification. In the event that COR specifies that the Bulk Product be shipped
to a location other than COR's principal offices (e.g., to a different location
[*]), or in the event that COR's shipping request requires that the Bulk Product
by placed into inventory for a period longer than [*], and upon COR's request,
Solvay shall ship a quality control sample to COR's principal offices (or such
other place as COR may designate) in advance of or not later than concurrently
with the shipment of the Bulk Product. Except as provided herein with respect to
non-conforming product, title and risk of loss as to all materials shipped shall
pass [*]. Solvay shall provide a packing list and a certificate of analysis to
COR for every shipment.
7.3 NON-CONFORMING PRODUCT. Bulk Product supplied hereunder
shall be produced by Solvay in accordance with applicable laws and regulations,
including current Good Manufacturing Practices as set forth in the United States
Code of Federal Regulations, in conformance with the Specification. COR may
reject any shipment of Bulk Product which (a) does not conform with the
Specification or (b) is adulterated or misbranded within the meaning of the
United States Federal Food, Drug and Cosmetic Act, equivalent European Union
regulatory agency requirements, or other applicable laws or governmental
regulations. Any notice of rejection of non-conforming product or notice that
the product is adulterated or misbranded must be submitted to Solvay within [*]
after shipment, accompanied by a report of analysis (including a product sample
from the lot analyzed) prepared according to the Specification. If no such
notice of rejection of non-conforming product is submitted, COR shall be deemed
to have accepted such delivery of the product. Product may be rejected as
non-conforming based on analysis of a product sample shipped in advance of or
concurrently with the full lot.
7.4 PROCEDURES AFTER NOTICE OF REJECTION. After notice of
rejection of non-conforming product is given, COR shall cooperate with Solvay in
determining whether rejection is necessary or justified. Solvay shall notify COR
promptly whether or not it accepts COR's
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basis for any rejection. If Solvay disagrees with COR's determination that a
certain product does not meet the Specification, such product shall be submitted
to a mutually acceptable third party laboratory; the fees and expenses of such
laboratory testing shall be borne entirely by the Party against whom such
findings are made. Such third party laboratory shall determine whether such
product meets the Specification and the Parties agree that such laboratory's
determination shall be final and determinative. Whether or not Solvay accepts
COR's basis for rejection, promptly on receipt of a notice of rejection of
non-conforming product, Solvay shall, at COR's request, use its best efforts to
replace such rejected product. In the event that the rejected lot is determined
to not meet the Specification, any moneys paid for the rejected lot shall be
credited against the cost of a replacement lot or returned to COR in the event
Solvay is unable to manufacture a replacement lot. Bulk Product may only be
reprocessed in accordance with validated reprocessing procedures described in
the drug master file, as agreed by the Parties.
Unless Solvay requests the destruction of rejected Bulk Product
within [*] of receipt of COR's notice of rejection of non-conforming product,
COR shall promptly return said Bulk Product to Solvay, at Solvay's cost [*] and
according to shipping instructions in the Specification. COR shall, upon receipt
of a request for destruction of the material, destroy such product promptly,
properly and at Solvay's expense, and provide Solvay with certification of such
destruction. In the event the Bulk Product is rejected by COR on the basis of
analysis of a product sample, Solvay shall retain the relevant lot of Bulk
Product and treat it in the same fashion provided above.
7.5 GOVERNING TERMS. All sales hereunder shall be subject to the
provisions hereof (including the Specification) and shall not be subject to the
terms and conditions contained on any shipping request of COR or confirmation of
Solvay, except insofar as any such shipping request or confirmation establishes:
(a) the quantity of any Bulk Product to be shipped; (b) the agreed delivery
date; (c) the shipment route and destination; or (d) the carrier.
8.0 PRICE AND PAYMENTS.
8.1 PRICES. COR agrees to pay to Solvay the prices for the
manufacture of Bulk Product set forth in Appendix C. Applicable pricing shall be
determined based on the total quantity of Bulk Product ordered in a particular
calendar year.
8.2 PRICE COMPUTATION. The payments to be made by COR to Solvay
for the quantity of Bulk Product stated in a Purchase Order shall be computed by
[*] in Appendix C. COR shall be entitled to a credit pursuant to Article 2.5 for
previous payments made pursuant to Article 2.4.
8.3 INVOICING AND PAYMENT. Payment for Bulk Product shall be
made in the following increments:
(a) Before [*] of each year for Purchase Orders placed
during that year, [*] of the Bulk Product price specified in Appendix C [*] in
the applicable Purchase Order;
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(b) Within [*] of receipt of Solvay's written
certification of the completion of the manufacture of Bulk Product through [*]
as described in Appendix A, [*] of the Bulk Product price specified in Appendix
C [*] stated in the applicable Purchase Order;
(c) Within [*] of receipt of Solvay's written
certification of the completion of the manufacture of Bulk Product through [*]
as described in Appendix A, [*] of the Bulk Product price specified in Appendix
C [*] in the applicable Purchase Order; and
(d) Within [*] of receipt of Solvay's written
certification of the completion of the manufacture of Bulk Product through [*]
as described in Appendix A, [*] of the Bulk Product price specified in Appendix
C [*] in the applicable Purchase Order.
8.4 METHOD OF PAYMENT. All payments shall be made in United
States Dollars by wire transfer to the bank account of [*] or to such account of
Solvay in such bank as Solvay may from time to time designate by notice to COR.
8.5 TAXES. Solvay shall be responsible for all value added
taxes, property taxes, sales tax or any other such tax resulting from sales of
Bulk Product to COR from Solvay or production of Bulk Product or purchase of any
raw materials.
8.6 PROCESS MODIFICATION. It is understood by both parties that
significant manufacturing cost reductions may be possible by negotiating with
regulatory authorities to achieve cost effective product specifications. The
parties shall discuss and agree on a mechanism by which the benefits of process
modifications to which COR contributed are equitably allocated to the parties
according to their relative contribution to a cost reduction.
8.7 COR'S RIGHT TO VERIFY MANUFACTURE CERTIFICATION. COR shall
have the right at its own expense to have an independent third party, acceptable
to Solvay, audit Solvay's production records, during normal business hours and
upon reasonable notice, for the purpose of verifying the manufacture of Bulk
Product in accordance with this Agreement as certified pursuant to Article 8.3.
Solvay's acceptance of the independent third party shall not be unreasonably
withheld.
8.8 OVERDUE PAYMENT. Payments provided for in this Article 8.0,
when overdue, shall bear interest at a rate per annum equal to [*] effective [*]
and for the time period until payment is made by COR.
8.9 [*] Without prejudice to any of Solvay's rights hereunder,
in the event that [*].
8.10 SHORT-TERM DELAY IN SUPPLY FROM NEW PRODUCTION CAPACITY.
Royalties payable to Solvay under the License Agreement will change in the event
that Bulk Product supply is delayed because the FDA or other regulatory
authority deems the New Production Capacity, environmental assessment, or any
other procedure or process followed by Solvay in the manufacture of Bulk Product
unacceptable and the problems cannot be remedied by the reasonable efforts of
Solvay prior to the intended commencement date of manufacture in the New
Production Capacity, resulting in either: i) a delay of less than [*] in the
supply of Bulk
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
11
Product; or ii) COR's seeking, for a period of time, the Secondary Source to
produce the quantities that would have been produced by Solvay, if COR and
Solvay nonetheless believe the problems can be remedied in a timely manner. In
either of these circumstances i) or ii), royalties payable to Solvay on Net Bulk
Sales by the Secondary Source as specified in the License Agreement will
decrease by [*] during the time period in question, until all necessary
regulatory approvals are achieved and the Production Capacity can produce the
ordered quantities.
8.11 OTHER DELAY IN SUPPLY. In recognition of the fact that long
term supply disruptions will affect the commercial viability of COR and
Integrelin(TM), in the event that Solvay is unable to consistently supply
conforming Bulk Product according to agreed schedules, then COR may elect to
obtain [*] of its Bulk Product supply needs from the Secondary Source for as
long as Solvay remains unable to supply. Additionally, no royalties shall be
paid during such time period on Net Bulk Sales to COR from a Secondary Source.
9.0 TERM AND TERMINATION.
9.1 TERM. The term of this Agreement shall commence on 28
September 1995 and will continue subject to the provisions of Article 9.2 (a) or
(b) until 31 December 2000. This Agreement shall automatically renew thereafter
in one (1) year increments until terminated pursuant to Article 9.2.
9.2 TERMINATION. This Agreement may be terminated: (a) upon
mutual written agreement between the Parties, (b) by either Party as a result of
a material breach or default in the performance of any obligation, condition or
covenant of this Agreement, if such default or noncompliance shall not have been
remedied, or steps initiated to remedy the same to the other Party's reasonable
satisfaction, within ninety (90) days after receipt by the defaulting Party of a
notice thereof from the other Party, or (c) by either Party on notice of its
intention to terminate, provided that such notice is served on the other Party
at least two (2) years before the termination becomes effective and further
provided that such termination shall not become effective at a time when a
Production Suite is considered "New".
9.3 EFFECT OF TERMINATION. The termination of this Agreement
shall not relieve Solvay from its obligation to deliver Bulk Product, or Bulk
Product Intermediates pursuant to Article 5.5, ordered by Purchase Orders
received and accepted by Solvay prior to the effective date of such termination,
nor shall termination relieve COR from accepting and, upon acceptance, paying
for any such Bulk Product and/or Bulk Product Intermediates. Termination shall
not limit COR's right to sell Integrelin(TM) produced from Bulk Product in its
possession or delivered to it after such termination. The provisions of Articles
6.0, 7.0, 8.0, 10.0 and 11.0 shall survive the termination of this Agreement.
Termination of this Agreement shall not affect the License Agreement or the
Supply Agreement.
10.0 INDEMNIFICATION, LIABILITY AND RECALLS
10.1 COR INDEMNIFICATION. COR shall indemnify, defend and hold
harmless Solvay and Solvay Affiliates from and against all costs, claims, suits,
expenses (including reasonable attorneys' fees) and damages arising out of or
resulting from:
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
12
(a) the use by or administration to any person of
Integrelin(TM) (except where such cost, claim, suit, expense or damage arose or
resulted from Solvay's negligence or willful misconduct, or an event specified
in Article 10.2); or
(b) infringement of any third party intellectual
property rights relating to Integrelin(TM) but not to the manufacture of Bulk
Product;
provided that Solvay gives prompt notice in writing to COR of any such claim or
action, tenders the defense of such claim or action to COR, assists COR if
requested by COR, at COR's expense in defending such claim or action and does
not compromise or settle such claim or action without COR's prior written
consent.
10.2 SOLVAY INDEMNIFICATION. Solvay shall indemnify, defend and
hold COR harmless from and against all costs, claims, suits, expenses (including
reasonable attorneys' fees) and damages arising out of or resulting from:
(a) any failure of the Bulk Product supplied by Solvay
under this Agreement to meet the Specification;
(b) any failure of Solvay to manufacture the Bulk
Product in accordance with Good Manufacturing Practices or any other applicable
government law or regulation; and
(c) infringement of any third party intellectual
property right relating to the manufacture, use or sale of Bulk Product but not
to Integrelin(TM) independent of its manufacture;
provided that COR gives prompt notice to Solvay of any such claim or action,
offers to tender the defense of such claim or action to Solvay, assists Solvay
if requested by Solvay, at Solvay's expense in defending such claim or action,
and does not compromise or settle such claim or action without Solvay's prior
written consent.
10.3 LIMITATION OF LIABILITY. Subject to Solvay's obligations
under Articles 10.2(c) and 10.4 and other than for death or personal injury
caused by Solvay's negligent or willful acts, Solvay's liability to COR under
this Agreement shall be limited to the free (to COR) replacement of Bulk Product
within a reasonable time, or the value thereof, provided that the information
Solvay originally submitted to COR about the batch of Bulk Product and the
manufacture of same was accurate. Neither Party shall be liable to the other for
indirect, incidental or consequential damages arising out of any of the terms or
conditions of this Agreement or with respect to its performance.
10.4 RECALLS. Solvay will indemnify and hold COR harmless from
the costs of Bulk Product recalled and up to [*] for any out-of-pocket expense
relating to implementation of a recall of any batch of Bulk Product supplied by
Solvay due to failure to meet the warranties set forth in Article 11.1 below.
For purposes of this Agreement, the expenses of recall shall be the expenses of
notification and destruction or return of the recalled Bulk Product, and any
costs directly associated with the distribution of replacement Bulk Product. COR
shall have the right
12.
CONFIDENTIAL TREATMENT REQUESTED = [*]
13
to control the arrangement of any recall, and the Parties will cooperate with
each other in implementing such recall.
11.0 WARRANTIES
11.1 WARRANTIES. Solvay warrants:
(a) that it will comply with all manufacturing
instructions and the Specification, including quality control standards provided
in accordance with this Agreement;
(b) that Bulk Product will be produced in accordance
with such instructions and specifications and with Good Manufacturing Practices
and other applicable laws, rules and regulations of the United States, the
European Union, and to the extent applicable, of European Union Member States;
and
(c) that, upon delivery of Bulk Product to [*] Bulk
Product will be in conformity with the Specification and with the United States
Food, Drug and Cosmetic Act, providing, inter alia, that the Bulk Product shall
not be adulterated or misbranded or otherwise of a nature which may not be
introduced into United States interstate commerce.
11.2 NO OTHER WARRANTIES. THE EXPRESS WARRANTIES MADE IN THIS
AGREEMENT, THE LICENSE AGREEMENT AND THE SUPPLY AGREEMENT ARE IN LIEU OF ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
12.0 GENERAL PROVISIONS.
12.1 COMPLAINTS. Solvay will report to COR in writing any
complaints and any information that it may receive relating to Integrelin(TM).
12.2 NOTICES. All notices and demands required or permitted to
be given or made pursuant to this Agreement shall be in writing and shall be
deemed given if delivered personally or be given by facsimile transmission
(receipt verified), telexed, mailed by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service (receipt
verified), properly addressed to the address of the Party to be notified as
shown below:
If to Solvay:
Peptisyntha & Cie, SNC
General Manager
▇▇▇, ▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇
▇-▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
If to COR:
COR Therapeutics, Inc.
President
13.
CONFIDENTIAL TREATMENT REQUESTED = [*]
14
▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇.▇.▇.
or to such other address as to which either Party may notify the other. Any
notice sent by facsimile transmission or telex shall be followed within
twenty-four (24) hours by a signed notice sent by first class mail, postage
prepaid.
12.3 ASSIGNMENT AND DELEGATION. Solvay may not assign its rights
and/or delegate its obligations under this Supply Agreement to any third party
without the prior written consent of COR, such consent not to be unreasonably
withheld, except in connection with the sale, merger or transfer of
substantially all of the stock or assets of Solvay or the sale, merger or
transfer of substantially all of the interests in or the assets of Peptisyntha
to any party who meets financial and ethical standards generally acceptable
within the pharmaceutical industry, providing that such assignee or delegatee
agrees to be bound by the terms of this Agreement, in which case the consent of
COR is not required. COR may assign its rights hereunder in whole or part, or
delegate any of its obligations hereunder to any party who meets financial and
ethical standards generally acceptable within the pharmaceutical industry,
except without such requirement of standards in connection with the sale, merger
or transfer of all or substantially all of the assets of COR relating to
Integrelin(TM), provided such assignee or delegatee agrees to be bound by the
terms of this Agreement.
12.4 PERFORMANCE BY AFFILIATES. The Parties recognize that each
may perform some or all of its obligations under this Agreement through
Affiliates as specified in this Agreement, provided however, that each Party
shall remain responsible and be guarantor of the performance by its Affiliates
and shall cause its Affiliates to comply with the provisions of this Agreement
in connection with such performance.
12.5 PERFORMANCE BY THIRD PARTIES. The Parties recognize that
Solvay may perform some or all of its manufacture and storage obligations under
this Agreement through a third party, with the prior written consent of COR,
such consent not to be unreasonably withheld. [*] Solvay shall remain
responsible and be guarantor of the performance by third parties performing its
obligations hereunder and shall cause such third parties to comply with the
provisions of this Agreement in connection with such performance.
12.6 GOVERNING LAW. This Agreement shall be governed by and
construed in accordance with the laws of England. Solvay and COR submit
irrevocably to the exclusive jurisdiction and venue of the English courts.
12.7 FORCE MAJEURE. Neither Party shall be liable to the other
for loss or damage, or, except as provided herein, have any right to terminate
this Agreement by virtue of an occurrence which prevents, delays or interferes
with the performance by a Party of any of its obligations hereunder, if such
occurs by reason of any Act of God, flood, fire, explosion, casualty or
accident, or war, revolution, civil commotion, acts of public enemies, blockage
or embargo, or any law, order or proclamation of any government, strike or other
labor trouble, failure of suppliers to deliver materials, equipment or
machinery, interruption of or delay in transportation, or any other cause
whatsoever, whether similar or dissimilar to those above enumerated, beyond the
reasonable control of such Party, if, and only if, the Party affected shall
14.
CONFIDENTIAL TREATMENT REQUESTED = [*]
15
have used its best efforts to avoid such occurrence. In such an event, the Party
affected shall notify the other and shall attempt to perform its obligations as
soon as possible.
12.8 ENTIRE AGREEMENT. This Agreement, together with the License
Agreement and the Supply Agreement, is the entire agreement between the Parties
with respect to the production of Bulk Product for 1997 and thereafter, and
shall terminate and supersede any prior written or oral promises or
representations with respect to the production of Bulk Product by Solvay for
1997 and thereafter between the Parties not incorporated herein. In the event of
conflict between this Agreement and the License Agreement, the terms of the
License Agreement shall control, except for the provisions of Articles 8.10 and
8.11 of this Agreement which shall be governed by the terms of this Agreement.
No amendment or modification of the terms of this Agreement shall be binding on
either Party unless reduced to writing and signed by the respective authorized
officers of the Parties.
12.9 SEVERABILITY. If any provision of this Agreement is
determined to be illegal or unenforceable by any Court of law or any competent
governmental or other authority, the remaining provisions shall be severable and
enforceable in accordance with their terms so long as this Agreement without
such terms or provisions does not fail of its essential purpose. The Parties
shall negotiate in good faith to replace any such illegal or unenforceable
provisions with suitable substitute provisions which will maintain as far as
possible the purposes and the effect of this Agreement.
12.10 RELATIONSHIP OF THE PARTIES. Nothing in this Supply
Agreement is intended or shall be deemed to constitute a partnership, agency,
employer-employee or joint venture relationship between the Parties. All
activities by the Parties hereunder shall be performed by them as independent
contractors. Neither Party shall incur any debts or make any commitments for the
other Party, except to the extent, if at all, specifically provided herein. No
right, express or implied, is granted by this Agreement to either Party to use
in any manner the name of the other or any other trade name or trade ▇▇▇▇ of the
other in connection with the performance of this Supply Agreement. Solvay shall
not, without first obtaining the written consent of COR, in any manner disclose
or publish the terms of this Agreement and/or the fact that Solvay has
contracted to furnish COR the goods and services which are the subject of this
Agreement.
12.11 WAIVER. Failure of either Party to insist upon strict
observance of or compliance with any of the terms of this Supply Agreement in
one or more instances shall not be deemed to be a waiver of its rights to insist
upon such observance or compliance with the other terms hereof, at that point in
time or in the future.
12.12 HEADINGS. All headings, titles and captions in this
Agreement are for convenience only and shall not be of any force or substance.
12.13 COUNTERPARTS. This Supply Agreement may be executed in
multiple counterparts, each of which shall be an original, but all of which
shall constitute but one agreement.
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
16
IN WITNESS WHEREOF, the Parties hereto have executed this Supply
Agreement to be effective on the date first set forth above.
COR THERAPEUTICS, INC. SOLVAY S.A.
By: By:
-------------------------------- --------------------------------------
Title: Title:
----------------------------- -----------------------------------
Appendix A: Production Scheme
Appendix B: Production Forecast
Appendix C: Bulk Product Price
Appendix D: Bulk Product Specification
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
17
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX A
PRODUCTION SCHEME
[*]
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
18
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX B
PRODUCTION FORECAST
[*]
18.
CONFIDENTIAL TREATMENT REQUESTED = [*]
19
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX C
BULK PRODUCT PRICE
The reference price for Bulk Product at the Specification, [*] shall be:
[*]
The unit price for Bulk Product shall be computed by [*].
19.
CONFIDENTIAL TREATMENT REQUESTED = [*]
20
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
APPENDIX D
BULK PRODUCT SPECIFICATION
I. BULK PRODUCT CONTENT AND TESTING
[*]
-----------------------------
[*]
20.
CONFIDENTIAL TREATMENT REQUESTED = [*]
21
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
[*]
[*]
21.
CONFIDENTIAL TREATMENT REQUESTED = [*]
22
Confidential Treatment
Requested = [*] Certain
confidential information
contained in this document,
marked by brackets, is filed
with the Securities and
Exchange Commission pursuant
to Rule 24b-2 of the
Securities Exchange Act of
1934, as amended.
[*]
22.
CONFIDENTIAL TREATMENT REQUESTED = [*]