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EXHIBIT 10.24
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.
LICENSE AND SUPPLY AGREEMENT
THIS Agreement is entered into effective as of 27 July 1994, between COR
Therapeutics, Inc. ("COR"), a Delaware corporation, with its principal offices
at 000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx XXX 00000, and Solvay,
Societe Anonyme ("Solvay"), a Belgian corporation, with its principal offices at
00, xxx xx Xxxxxx Xxxxxx - 000 Xxxxxxxxx, Xxxxxxx 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.
WlTNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and know-how
relating to a product called Integrelin(TM);
WHEREAS Solvay has developed a unique and valuable patented and
proprietary process useful for the manufacture of bulk peptide products
containing Integrelin(TM);
WHEREAS COR has entered into a Confidentiality Agreement as of 24 July
1990 with the Solvay Affiliate Peptisyntha & Cie, Societe en Nom Collectif;
WHEREAS Peptisyntha and COR have entered into a Process Development
Agreement dated 11 October 1990 and amended as of 10 March 1993 for the
development by Solvay of a process for the manufacture of a bulk peptide product
containing Integrelin and for the supply of the same to COR;
WHEREAS COR is willing to purchase from Solvay and Solvay is willing to
manufacture for and to sell to COR additional quantities of a bulk peptide
product containing Integrelin; and
WHEREAS Solvay is willing to provide access to and a license of certain
technology developed by Solvay for the manufacture by a Secondary Source of bulk
peptide products
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containing Integrelin using the process developed by Solvay on the terms and
conditions herein set forth;
NOW THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the Parties agree as follows:
1.0 Certain Definitions. For the purposes of this Agreement, the
following terms shall have the following meanings:
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 section 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 on the foregoing and for purposes of this
Agreement, Peptisyntha & Cie, Societe en Nom Collectif ("Peptisyntha"), which is
a fully owned subsidiary of Solvay and an entity existing under the laws of
Belgium and having its principal offices at 000, xxx xx Xxxxxxxx - 0000
Xxxxxxxxx, Xxxxxxx, and also Solvay Duphar B.V., a Dutch corporation having its
main office at X.X. van Xxxxxxxxxx, 00, Xxxxx, Xxx Xxxxxxxxxxx, are deemed
Affiliates of Solvay.
1.2 "Bulk Product" shall mean a bulk peptide product which
contains Integrelin, is produced by the Licensed Process 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.
1.4 "Effective Date" shall mean 27 July 1994.
1.5 "Force Majeure" shall mean 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
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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 have
used its reasonable best efforts to avoid such occurrence.
1.6 "Good Manufacturing Practices" shall mean the good
manufacturing practices required by the U.S. Food and Drug Administration for
the manufacture and testing of pharmaceutical materials including bulk peptide
products, and the corresponding requirements of the European Union and, to the
extent they are applicable, of Member States of the European Union.
1.7 "Integrelin" 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.
1.8 "Licensed Process" shall mean any process or process(es)
developed or acquired by Solvay presently or in the future and used commercially
for making bulk peptide products containing Integrelin according to COR's
specifications, during the term of any supply arrangements between COR and
Solvay or a Secondary Source.
1.9 "Net Bulk Sales" shall mean as to each calendar quarter the
gross invoiced sales price charged for all Bulk Products sold to COR by a
Secondary Source, after deducting the following items paid by COR during such
calendar quarter with respect to sales of Bulk Product hereunder regardless of
the calendar quarter in which such sales were made, provided and to the extent
that such items are incurred, and are included in the price charged:
(a) trade, quantity and case discounts or rebates:
(b) credits or allowances given or made for rejection or
return of previously sold Bulk Product;
(c) any tax or government charge (other than an income
tax) levied on the sale, transportation or delivery of Bulk Product and borne by
the seller thereof; and
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(d) any charges for freight or insurance in a CIF sale.
1.10 "Secondary Source" shall mean the party established
hereunder for the manufacture and supply of Bulk Product for COR.
1.11 "Solvay Know-how" shall mean all information now or
hereafter in the possession of Solvay, whether or not patentable or disclosed
within the Solvay Patents, constituting materials, methods, processes,
techniques and data which are useful [*] for the manufacture of Bulk Product and
which relate to the Licensed Process which Solvay has the right to license or
disclose without violating existing contractual obligations to third parties.
1.12 "Solvay Patents" shall mean all patents (including
inventor's certificates) and applications therefor throughout the world and
substitutions, extensions, reissues, renewals, divisions, continuations or
continuations-in-part thereof or therefor, which Solvay presently or hereafter
owns or controls, or under which Solvay now or hereafter shall have the right to
grant a sublicense, to the extent they cover the Licensed Process, or to the
extent that they cover Integrelin manufactured by the Licensed Process. A list
of such Solvay Patents is attached hereto as Exhibit A.
2.0 Supply of Integrelin
2.1 Supply of Bulk Product. Solvay agrees to supply Bulk Product
to COR, and COR agrees to purchase Bulk Product from Solvay, pursuant to the
terms of the Supply Agreement attached as Exhibit B. Solvay and COR agree to
continue to negotiate in good faith an agreement for the long-term supply of
Bulk Product. It is contemplated that Solvay may fulfill its obligation to
supply Bulk Product to COR under the long-term supply agreement by having a
third party manufacture on its behalf part or all of the Bulk Product
Intermediates or the Bulk Product required by COR provided that such
manufacturing activities would not affect the regulatory status of Integrelin.
2.2 Secondary Supply. COR shall have the right to establish a
Secondary Source for the manufacture of Bulk Product by the Licensed Process for
COR. The Secondary Source shall be [*]. COR and Solvay agree that a [*], would
be acceptable as the Secondary Source. COR will notify Solvay of the
establishment of the Secondary Source. In the event
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COR terminates a supply arrangement with a Secondary Source, COR may establish
an alternate Secondary Source. COR shall notify Solvay within [*] of such a
termination of supply arrangements with a Secondary Source. COR's future
requirements for Bulk Product [*] COR wants to entertain certain [*]. Therefore,
after the Secondary Source is established, COR shall be [*] of its total,
worldwide requirements for Bulk Product on a year-to-year basis (to the extent
that such [*] does not exceed the manufacturing capacity planned by Solvay to
product Bulk Product) for the time period during which royalties are payable
under this Agreement. For purposes of the preceding sentence, such planned
capacity shall be determined for a particular calendar year X on [*].
Notwithstanding the above however, COR may purchase from such Secondary Source
[*] in the event of any breach or default of Solvay of any supply arrangement
between COR and Solvay, [*]. If by 15 March 1995, Solvay and COR have not
completed an agreement for the long-term supply of Bulk Product, provided that
COR and Solvay have been negotiating in good faith an agreement for the
long-term supply of Bulk Product, [*], COR may establish an additional,
"Back-up" Secondary Source for the manufacture of Bulk Product. In the event
that COR wishes to establish [*], then COR and Solvay shall negotiate in good
faith, before [*].
3.0 Licenses
3.1 Grant by Solvay. Solvay hereby grants to COR under the
Solvay Patents and Solvay Know-how an irrevocable (subject to Section 5.2), sole
- with Solvay and Solvay Affiliates - worldwide license, with right to
sublicense to the Secondary Source and the Back-up Secondary Source, to develop,
use for regulatory or legal purposes, sell, have sold, and either manufacture
[*], or have manufactured by the Secondary Source and/or Back-up Secondary
Source [*]. Integrelin and products containing Integrelin produced practicing
the Solvay Know-how or the Licensed Process. No other rights than those
expressly provided in this Agreement and the Supply Agreement are granted by
Solvay to COR or any Secondary Source by implication or otherwise. COR [*]. Any
rights sublicensed to the Secondary Source or Back-up Secondary Source, pursuant
to this Section 3.1 shall not be further transferred without the prior written
consent of Solvay. For the purpose of this Section 3.1, "sole" license shall
mean that Solvay shall not grant to any third party any right during the term of
this Agreement under the
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Solvay Patents and Solvay Know-how to manufacture bulk peptide products
containing Integrelin or to use or sell Bulk Products manufactured thereby.
3.2 Grant by COR. COR hereby grants to Solvay a non-exclusive,
worldwide license, without right to sublicense, under COR's patents and know-how
covering Integrelin, for the sole purpose of manufacturing Bulk Product for COR
during the term of any Bulk Product supply arrangement between COR and Solvay.
This license shall not be assigned or transferred without the prior written
consent of COR.
3.3 Process Improvements. The Parties acknowledge that Solvay or
COR may develop or acquire improvements to the manufacturing materials,
equipment, procedure, Solvay Know-how or Licensed Process in the course of
fulfilling its obligations under this Agreement and the Supply Agreement. Solvay
agrees to obtain COR's consent prior to implementing such improvements, or any
changes in the Licensed Process or [*]. Any such improvements developed or
acquired by Solvay which are used commercially by Solvay or the Secondary Source
and/or Back-up Secondary Source for making bulk peptide products containing
Integrelin shall be deemed to be within the definition of Licensed Process or
Solvay Know-how as licensed in Section 3.1.
Except as provided below, COR hereby agrees to establish only a
Secondary Source (and/or Back-up Secondary Source) which agrees to grant back to
COR a non-exclusive, worldwide, royalty-free license, sublicenseable by COR to
entities entitled to practice the Licensed Process, to use any improvements to
the manufacturing materials, equipment, procedure, Solvay Know-how or the
Licensed Process related to this Agreement which are developed or acquired by
such Secondary Source, to develop, use, sell, have sold, [*] or have
manufactured by the Secondary Source (and/or Back-up Secondary Source) [*] of
this Agreement, Integrelin and products containing Integrelin. COR hereby agrees
to sublicense the rights granted to it pursuant to this Section 3.3 by a
Secondary Source (and/or Back-up Secondary Source) to Solvay, for use by Solvay
during any time period wherein Solvay is supplying COR with Bulk Product,
pursuant to the terms of any supply arrangement between COR and Solvay. COR
agrees that it will use any such Secondary Source improvements to
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manufacture Bulk Product [*] is the Secondary Source, [*] COR [*] such Secondary
Source improvements to manufacture Bulk Product [*] Secondary Source when COR
[*].
For purposes of this Section 3.3, COR, Solvay and any Secondary Source
shall exchange rights to the improvements specified in this Section 3.3 which
are developed or acquired by any of them during the time period between the
Effective Date and [*] at which time COR and Solvay agree to consider in good
faith, in consultation with any Secondary Source, whether or not the exchange of
improvements should be continued beyond [*].
In the event that COR establishes itself as the Secondary Source (and/or
Back-up Secondary Source), COR hereby agrees to grant to Solvay a worldwide,
royalty-free license, without right to sublicense, to use any improvements to
the manufacturing materials, equipment, procedure, Solvay Know-hew or the
Licensed Process related to this Agreement which are owned or developed by COR,
to develop, manufacture, have made, use, sell and have sold Integrelin and
products containing Integrelin, according to the terms of this Agreement, and
for use by Solvay during any time period wherein Solvay is supplying COR with
Bulk Product, pursuant to the terms of any supply arrangement between COR and
Solvay.
In the event that, despite good faith negotiations, a potential
Secondary Source with whom COR desires to contract is unable or refuses to grant
rights to its improvements to COR for further sublicense, then COR agrees that
any [*] or [*] by Solvay upon or after the establishment of that Secondary
Source shall [*] that Secondary Source, to be [*].
3.4 Technology Transfer to COR. Promptly upon execution of this
Agreement and updated at least quarterly, Solvay shall provide to COR in a
written form, [*] the Solvay Know-how which is useful [*] for supporting COR's
efforts to obtain appropriate regulatory approvals needed to market products
containing Integrelin, including by way of example, [*] and any documents which
result from inspection by governmental agencies [*]. COR agrees that such Solvay
Know-how shall be distributed by COR only to those employees designated by COR
as having a need to know such information (e.g., in COR's regulatory,
development and manufacturing, and legal departments) who sign personal
obligations of confidentiality with Solvay with respect to Solvay Confidential
Information; COR further agrees to guarantee such personal obligations of
confidentiality made by COR employees.
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3.5 Technology Transfer to the Secondary Source. Promptly upon
the notification by COR to Solvay of the establishment of the Secondary Source
or the Back-up Secondary Source pursuant to Sections 2.2, 3.3 and 3.5 of this
Agreement, and updated at least quarterly, Solvay shall provide to the Secondary
Source in a written form, [*] Solvay Know-how useful for the manufacture of Bulk
Product, including by way of example, [*] and any documents which result from
inspection by governmental agencies [*]. Solvay shall disclose [*]. During the
term of this Agreement, Solvay shall continue to provide such technical
assistance and access to information, as may be useful for the Secondary Source
to manufacture Bulk Product by the Licensed Process and to obtain appropriate
regulatory approvals for the sale of products containing Integrelin.
COR shall require the Secondary Source to agree that such Solvay
Know-how shall be distributed by the Secondary Source only to those employees
designated by the Secondary Source as having a need to know such information,
and who sign personal obligations of confidentiality with Solvay with respect to
Solvay Confidential Information. COR shall require the Secondary Source to
further agrees to guarantee such personal obligations of confidentiality made by
employees of the Secondary Source.
3.6 Escrow of Technology. [*] Solvay shall deposit to a third
party escrow acceptable to COR and Solvay, all such technical information in
English language written form. Such escrow of [*] technical information shall be
updated at least quarterly by Solvay. Access to this escrowed information may be
made by COR upon [*] or [*] or [*], or [*] or [*] or [*]:
(a) failure by Solvay to transfer relevant technology
to a Secondary Source under Section 3.5 of this
Agreement, within [*] of notice by COR to Solvay
of the establishment of that Secondary Source or
on an ongoing basis [*] of a request from the
Secondary Source (or from COR on behalf of the
Secondary Source) for applicable information
within Solvay's possession, unless Solvay is in
the process of attempting in good faith to remedy
such failure, in which case [*];
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(b) failure by Solvay to transfer relevant technology
to COR under Section 3.4 of this Agreement, on an
ongoing basis within [*] of a request from COR to
Solvay for applicable information within Solvay's
possession, unless Solvay is in the process of
attempting in good faith to remedy such failure,
in which case [*];
(c) in the event that Solvay assigns or transfers to a
third party the Licensed Process, or any of its
rights or obligations under this Agreement or the
Supply Agreement inconsistently with the
provisions of Section 10.2 of this Agreement or
Section 6.6 of the Supply Agreement;
(d) in the event of any assignment by Solvay or
Peptisyntha of substantially all of its assets for
the benefit or creditors, or the placement of
substantially all of Solvay or Peptisyntha's
assets in the hands of a receiver unless the
receivership is dissolved within [*] thereafter,
or
(e) upon judicial order.
4.0 Payments and Royalties.
4.1 License Issue Fee. Within [*] of the Effective Date, COR
shall pay to Solvay a license issue fee of [*].
4.2 Royalty Payments. COR shall pay Solvay a running royalty
computed at the following rates:
(a) until the [*] anniversary of the first commercial
launch by COR of a product containing Integrelin,
[*] of Net Bulk Sales, and
(b) after the [*] anniversary of the first commercial
launch by COR of a product containing Integrelin
and until [*] of Net Bulk Sales of Bulk Product
manufactured, used or sold in any country or
territory where valid and enforceable patent
claims covering the Licensed Process or products
manufactured by the Licensed Process exist. The
period for payment of royalties [*].
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4.3 Minimum Annual Royalty. Before the [*] the first commercial
launch by COR of a product containing Integrelin and before the [*] until and
including the [*] anniversary of such first commercial launch, COR shall make to
Solvay an advance payment of [*] of which each such payment shall be refundable
either as a credit against all payments to be made by COR to Solvay under
Section 4.2 during the following year, or as a credit against [*] of the gross
invoiced sales price for all Bulk Product sold to COR by Solvay during the
following year, after deducting the following items provided and to the extent
that such items are incurred, and are included in the price charged:
(a) trade, quantity and case discounts or rebates;
(b) credits or allowances given or made for rejection
or return of previously sold Bulk Product;
(c) any tax or government charge (other than an income
tax) levied on the sale, transportation or
delivery of Bulk Product and borne by the seller
thereof; and
(d) any charges for freight or insurance in a CIF
sale.
4.4 Payment Dates. COR shall pay royalties to Solvay within [*]
of the end of each calendar quarter for that calendar quarter. Such payment
shall be accompanied by a statement showing the amount of Bulk Product sold, on
a country-by-country, currency-by-currency basis.
4.5 Records and Accounting. COR shall keep complete and accurate
records of the latest [*] calendar years of Net Bulk Sales with respect to which
a royalty is payable under this Agreement. Solvay shall have the right at its
own expense to have an independent, certified public accountant, reasonably
acceptable to COR and acting on a confidential basis, review COR's business
records upon reasonable notice and during reasonable business hours for the
purposes of verifying the payments provided for in this Agreement. This right
may not be exercised more than once in any calendar year. In the event such
review reveals a willful misstatement of royalties owed, in which instance the
expense of such independent review shall be paid by COR.
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4.7 Currency of Payments. All payments to Solvay by COR under
this Agreement shall be made in United States Dollars by wire transfer (or such
other reasonable means as Solvay may direct) to the bank account of [*] or such
bank account as Solvay may designate from time to time. Any payments clue
hereunder on sales outside of the United States shall by payable in United
States Dollars at the prevailing rate of exchange of the currency of the country
or collective of countries in which the sales are made in accordance with each
Party's customary and usual translation procedures (which are in accord with
generally accepted accounting principles consistently applied).
4.8 Taxes. Solvay shall pay any and all taxes levied on account
of royalties it receives under this Agreement. If laws or regulations require
that taxes be withheld, COR will (a) deduct those taxes from the remittable
royalty, (b) timely pay the taxes to the proper taxing authority, and (c) send
proof by certificate or other evidence of payment as required by the tax
authorities to Solvay promptly following receipt of such proof.
4.9 Expenses for Training and Technology Transfer. COR shall pay
to Solvay, as compensation for technical assistance to COR or the Secondary
Source in the transfer of information including the Solvay Know-how and the
Licensed Process, and for training to personnel of the Secondary Source [*] the
amount of [*] any Solvay employee is providing such technical assistance or
training. From the [*] this amount shall be [*] for the [*]. COR shall also bear
all actually incurred [*] for Solvay personnel working for the benefit of COR or
the Secondary Source [*] upon invoice, with supporting documentation, from
Solvay.
4.10 Overdue Payment. Payments provided for in this Section 4.0,
when overdue, shall bear interest at a rate per annum equal to [*] effective [*]
and for the time period until such payment is received by Solvay, without
prejudice of any other available remedies.
5.0 Termination
5.1 Term. This Agreement shall become effective on the Effective
Date and shall remain in effect until the thirty-first (31st) day of December
2020, unless earlier terminated as provided in this Section 5.0.
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5.2 Early Termination.
(a) If either Party shall default in a material manner
with respect to any material provision of this
Agreement and the other Party shall have given the
defaulting Party notice of such default, the
defaulting Party shall have ninety (90) days to
cure such default. If such default is not cured
within such ninety (90) day period, the
nondefaulting Party shall have the right, upon
notice to the defaulting Party and without
prejudice to any other rights it may have, to
terminate this Agreement unless the defaulting
Party is in the process of attempting in good
faith to remedy such default, in which case the
ninety (90) day cure period shall be extended by
an additional sixty (60) days;
(b) If the other Party (the "Troubled Party") makes
any assignment of substantially all of its assets
for the benefit of creditors, or places
substantially all of its assets in the hands of a
receiver or judicial manager unless the
receivership or judicial management is dissolved
within thirty (30) days thereafter, goes into
liquidation, or is dissolved, wound up,
confiscated, sequestered or in any other way
transferred into state ownership, then the
non-Troubled Party may terminate this Agreement
forthwith upon ten (10) days written notice to the
Troubled Party.
5.3 Effects of Expiration or Termination. After expiration of
this Agreement, the provisions of Sections 4.0 and 8.0 shall survive, and the
Parties shall be free to practice the Licensed Process and the Improvements as
of the year 2000. In the event of early termination by COR due to default by
Solvay, or if Solvay is the Troubled Party, the provisions of Sections 3.1, [*]
4.0 and 8.0 shall survive, and COR shall be free, within the context of the
obligations of the surviving Sections, to practice the Licensed Process and any
Solvay Improvements incorporated into the Licensed Process prior to the
termination. In the event of early termination by Solvay due to default of COR
or if COR is the Troubled Party, the provisions of Sections 4.0 and 8.0 of this
Agreement shall survive.
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6.0 Representations and Warranties.
6.1 Mutual Representations and Warranties. Each Party hereby
represents and warrants to the other Party that to the best of its knowledge
this Agreement and the Supply Agreement are legal and valid obligations binding
upon such Party and enforceable in accordance with their terms. The execution,
delivery and performance of this Agreement and the Supply Agreement by such
Party does not conflict with any agreement, instrument or understanding, oral or
written, to which it is a party or by which it is bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having jurisdiction over it.
6.2 Solvay Representations and Warranties. Solvay represents and
warrants that it is entitled to grant the rights granted under Section 3.0
hereof, and that Solvay has not, and during the term of this Agreement and the
Supply Agreement will not, grant any right to any third party relating to the
Solvay Patents and Solvay Know-how which would conflict with the rights granted
hereunder. Solvay further represents that to the best of its present knowledge
the Solvay Patents cover patentable inventions and are valid and enforceable.
Solvay represents that to the best of its present knowledge the Licensed Process
and Solvay Know-how can be practiced without infringing the rights of any third
party.
6.3 COR Representations and Warranties. COR represents and
warrants that it has not, and during the term of this Agreement and the Supply
Agreement will not, grant any right to any third party relating to the Solvay
Patents and Solvay Know-how which would conflict with this Agreement.
6.4 No Representation of Approvability. Nothing in this
Agreement or the Supply Agreement shall be construed as a representation or
warranty that the manufacture, sale or use of Integrelin or products containing
Integrelin shall be approved by any appropriate governmental agency.
6.5 No Other Warranties. The express warranties made in this
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.
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6.6 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 and the Supply 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 and the Supply Agreement in connection with such
performance.
6.7 Performance by Secondary Source. COR shall remain
responsible and be guarantor of the performance by its Secondary Source under
this Agreement and the Supply Agreement and shall cause its Secondary Source to
comply with the provisions of this Agreement and the Supply Agreement in
connection with such performance.
6.8 Limitation of Liability. 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.
7.0 Patent Rights. The Parties recognize that in the course of work
under this Agreement, either Party may independently make or come to control
inventions (including without limitation, processes and methods) respecting Bulk
Product. In such event, the Party making the invention shall be the sole owner
of that invention. With respect to any inventions that are jointly made by the
Parties including also any inventions made by one obliged to assign an invention
to a Party (i.e., inventions in which one or more inventors from each Party have
made an inventive contribution as determined by English laws of inventorship)
concerning Bulk Product or processes or methods relating to Bulk Product, the
Parties shall own such inventions (and any patent applications filed on such
inventions and any patents issued on such inventions) jointly as co-owners of
equal, undivided shares without right of accounting for any act carried out in
accordance with the invention, and agree to cooperate in filing any patent
applications and undertaking all other reasonable and appropriate protection for
such patentable joint inventions. Solvay shall have the first right, but no
obligation, to undertake such filings and prosecutions respecting jointly held
inventions, subject to reimbursement from COR for one-half of any reasonable
out-of-pocket expenses Solvay incurs in such filing and prosecution. In the
event Solvay fails to undertake the filing of such a patent application within
[*] of a notice by COR to
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Solvay that it believes the filing of such an application is appropriate, COR
may undertake such a filing at its own expense in which event any subsequently
issued patent application shall be owned solely by COR. As to the enforcement of
jointly owned patents, including actions against an infringer, the Parties shall
consult with each other in good faith as to the best manner in which to proceed.
The Parties agree as a basic principle that in the case of such actions against
infringers, the expenses incurred and damages awarded shall be for the account
of the Party or Parties undertaking such actions to the extent of their
financial participation therein. Either Party may assign its rights to any
jointly owned invention, application or subsequently issued patent on notice to
the other Party, which other Party shall then have the right to assume the
prosecution and/or maintenance as the sole owner thereof.
8.0 Confidentiality.
8.1 Confidentiality and Exceptions. In the course of the
performance of this Agreement, one Party may disclose to the other or receive
information from the other relating to the subject matter of this Agreement and
of the Supply Agreement which information, if so identified upon disclosure,
shall be considered to be the disclosing party's Confidential Information.
Confidential Information shall include in the case of COR, information relating
to the structure of Integrelin. Each Party agrees that it will take the same
steps to protect the confidentiality of the other Party's Confidential
Information as it takes to protect its own proprietary and confidential
information. Each Party shall protect and keep confidential and shaft not use,
publish or otherwise disclose to any third party, except as permitted by this
Agreement, the Supply Agreement, or with the other Party's written consent, the
other Party's Confidential Information. For the purposes of this Agreement,
Confidential Information shall not include such information that:
(a) was already known to the receiving Party, other
than under an obligation of confidentiality, at
the time of disclosure by the other Party;
(b) was generally available to the public or was
otherwise part of the public domain at the time of
disclosure or became generally available to the
public or otherwise part of the public domain
after
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
16
disclosure other than through any act or omission
of the receiving party in breach of this
Agreement; or
(c) was lawfully disclosed to the receiving Party,
other than under an obligation of confidentiality,
by a third party who had no obligation to the
disclosing Party not to disclose such information
to others.
8.2 Authorized Disclosure. Each Party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably necessary for
prosecuting or defending litigation, complying with applicable governmental
regulations or conducting preclinical or clinical trials, provided that if a
Party is required by law or regulation to make any such disclosure of the other
Party's Confidential Information it will, except where impracticable for
necessary disclosures, for example in the event of medical emergency, give
reasonable advance notice to the other Party of such disclosure requirement and
will use its reasonable efforts to secure confidential treatment of such
Confidential Information required to be disclosed. In addition, COR shall be
entitled to disclose, under a binder of confidentiality containing provisions as
protective as those of this Section 8.0, Solvay Confidential Information to any
Secondary Source permitted under Sections 2.2 and 3.0 of this Agreement. Nothing
in this Section 8.0 shall restrict any Party from using for any purpose any
information developed by it during the course of this Agreement. Neither Party
shall disclose Confidential Information of the other Party in any patent filings
without the prior written consent of the disclosing Party.
8.3 Survival. All obligations of confidentiality and non-use
imposed upon the Parties under this Agreement shall expire on [*].
8.4 Termination of Prior Agreement. This Agreement supersedes
all confidentiality arrangements previously entered into between the Parties.
Any disclosures between COR and Solvay or Solvay Affiliates made prior to the
Effective Date of this Agreement of confidential information related to the
Licensed Process, Bulk Product or to Integrelin shall be considered Confidential
Information covered by Section 8.0.
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
17
8.5 Confidentiality and Limitation on Use. COR agrees, and shall
require any Secondary Source to agree, to not disclose Solvay Know-how to any
third party and not to use Solvay Know-how for any purpose other than the
production of Bulk Product, except for necessary disclosures to governmental
agencies such as the U.S. Food and Drug Agency and its equivalents, according to
the provisions of Section 8.0. COR shall require the Secondary Source to sign a
three-way confidentiality agreement (with COR and Solvay) in the form of Exhibit
D or in a form substantially similar to that of Exhibit D hereto but having
changes agreed to by COR and Solvay.
9.0 Patent Infringement.
9.1 Notification of Infringement. COR shall promptly notify
Solvay of any violation by a third party of any Solvay Patent of which it is
aware, and shall provide Solvay with available evidence of such violation.
9.2 Enforcement of Solvay Patents. Upon reasonable notice and
evidence of infringement, the Parties agree to consult with each other as to the
best manner in which to xxxxx the infringement, considering the best interest of
both Parties. Solvay shall have the right to bring any suit or action for
infringement of Solvay Patents in force covering the Licensed Process. The costs
of such action shall be borne by Solvay, and any amount recovered shall be owned
by Solvay.
9.3 Defense and Settlement of Third Party Claims. If a third
party asserts that a patent or other right owned by it is infringed by the
manufacture, use or sale of Integrelin manufactured by the Licensed Process in
accordance with this Agreement or the Supply Agreement, by reason of such
manufacture, the Party first obtaining knowledge of such a claim shall
immediately provide the other Party notice of such claim and the related facts
in reasonable detail. Solvay agrees to investigate the situation fully in
collaboration with COR, and the Parties agree to discuss how best to control the
defense of any such claim. In the event the Parties cannot agree on the defense
of any such claim, Solvay shall have the right, but not the obligation, to
control such defense. COR shall have the right to be represented separately by
counsel of its own choice.
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
18
10.0 General Provisions.
10.1 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 by given by facsimile transmission
(receipt verified), telexed, mailed by registered or certified mail (return
receipt requested), postage prepaid, or sent by express courier service,
properly addressed to the address of the Party to be notified as shown below:
If to Solvay:
Solvay, S.A.
Head of Licensing Department
Xxx xx Xxxxxx Xxxxxx, 00
X-0000 Xxxxxxxxx, Xxxxxxx
If to COR:
President, COR Therapeutics, Inc.
000 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx, 00000 U.S.A.,
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.
10.2 Assignment and Delegation. Solvay may not assign its rights
and/or delegate its obligations under this Agreement or any three-way
confidentiality agreement pursuant to Section 8.5, to any third party without
the prior 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 assets of Peptisyntha, providing 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 in whole or in part,
or delegate any of its obligations, under this Agreement or any three-way
confidentiality agreement pursuant to Section 8.5, 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 rights of COR
relating to Integrelin, provided such assignee or delegatee agrees to be bound
by the terms of this Agreement.
18.
CONFIDENTIAL TREATMENT REQUESTED = [*]
19
10.3 Exclusivity. Solvay shall not engage in, or enable any
third party to engage in, any commercialization, licensing, manufacturing,
marketing or sales activity with respect to the application of Solvay Know-how
or the Licensed Process to Integrelin with or on behalf of any third party
without COR's prior written consent, except as expressly provided in this
Agreement.
10.4 Governing Law. This Agreement shall be governed by the laws
of England. Solvay and COR consent to the exclusive jurisdiction and venue of
the courts of England.
10.5 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 Force Majeure. In the event of Force Majeure, the
Party affected shall notify the other and shall attempt to perform its
obligations as soon as possible.
10.6 Entire Agreement. This Agreement (including the Supply
Agreement attached as Exhibit B hereto) is the entire agreement between the
Parties and shall terminate and supersede any prior written or oral promises or
representations between the Parties not incorporated herein. 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.
10.7 Binding Effect. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective successors and
permitted assigns.
10.8 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.
19.
CONFIDENTIAL TREATMENT REQUESTED = [*]
20
10.9 Publicity. Solvay and COR agree that, except as may
otherwise be required by applicable laws, regulations, rules, or orders, no
information concerning this Agreement and the transactions contemplated herein
shall be made public by either Party without the prior written consent of the
other.
10.10 Waiver. Failure of either Party to insist upon strict
observance of or compliance with any of the terms of this 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.
10.11 Headings. All headings, titles and captions in this
Agreement are for convenience only and shall not be of any force or substance.
10.12 Counterparts. This Agreement may be executed in multiple
counterparts, each of which shall be an original, but all of which shall
constitute but one agreement.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement to
be effective on the date first set forth above.
COR THERAPEUTICS, INC. SOLVAY S.A.
BY: BY:
-------------------------------- --------------------------------------
TITLE: TITLE:
----------------------------- -----------------------------------
Exhibit A: Solvay Patents
Exhibit B: Supply Agreement
Exhibit C: Secondary Sources
Exhibit D: Three-way confidentiality agreement
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.
EXHIBIT A
SOLVAY PATENTS
[*]
[*]
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 = [*]
23
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.
[*]
[*]
23.
CONFIDENTIAL TREATMENT REQUESTED = [*]
24
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.
[*]
[*]
24.
CONFIDENTIAL TREATMENT REQUESTED = [*]
25
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.
EXHIBIT B
SUPPLY AGREEMENT
THIS Agreement is entered into effective as of 27 July 1994, between COR
Therapeutics, Inc. ("COR"), a Delaware corporation, with its principal offices
at 000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx XXX 00000, and Solvay,
Societe Anonyme ("Solvay"), a Belgian corporation, with its principal offices at
00, xxx xx Xxxxxx Xxxxxx - 00 Xxxxxxxxx, Xxxxxxx 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
made and entered into as of 27 July 1994 (the "License Agreement"); and
Pursuant to the terms and conditions of the License Agreement, Solvay
has agreed to supply COR with bulk peptide products containing Integrelin for
the preparation, use and sale of discrete products containing Integrelin;
NOW, THEREFORE, COR and Solvay agree as follows:
1.0 Certain Definitions. For the purposes of this Agreement, the
following terms shall have the following meanings:
1.1 "Specification" shall mean the specification for Bulk
Product as agreed to by the Parties and as may thereafter be amended from time
to time to reflect changes in such Specifications. The current Specification is
contained in Appendix 1 to this Supply Agreement.
Unless otherwise defined herein, other capitalized terms used herein shall have
the meaning specified in the License Agreement.
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
26
2.0 Supply of Products.
2.1 Purchase and Sale of Products. During the term of this
Supply Agreement, Solvay agrees to supply Bulk Product to COR, and COR agrees to
purchase Bulk Product from Solvay.
2.2 Purchase Commitment. Notwithstanding COR's right to purchase
from a Secondary Source as provided in the License Agreement, COR agrees to
purchase, and Solvay agrees to supply, an amount of Bulk Product equivalent to
[*] according to the agreed Specification and to use its best efforts to ship
according to the shipping schedule in Appendix 2. In the event that COR wishes
to purchase more than these amounts during [*]. Solvay agrees to use its
reasonable efforts to supply additional amounts ordered by COR at the price in
Appendix 3 and according to the delivery schedule in Appendix 2.
2.3 Inventory. It is contemplated that a long-term supply
agreement between the Parties will involve an obligation by Solvay to maintain,
on agreed terms and conditions, an inventory of Bulk Product of not less than
[*]. The inventory will be maintained at a warehouse [*]. Such inventory shall
be rotated to maintain an average time in inventory of [*].
2.4 Intermediates. It is contemplated that a long-term supply
agreement between the Parties will involve an obligation by Solvay to maintain,
on agreed terms and conditions, an inventory of certain Bulk Product
Intermediates of not less than [*]. Such inventory shall be rotated to maintain
an average time in inventory of [*]. For Bulk Product Intermediates utilized
pursuant to this Supply Agreement and any long term Supply Agreement between the
Parties, Solvay shall retain samples of lots of Bulk Product Intermediates used
in the manufacture of Bulk Product until such Bulk Product has been shipped to
and accepted by COR.
2.5 Product Estimates and Shipping Requests. With respect to
COR's administrative effectuation of its orders of Bulk Product, COR shall send
firm shipping requests for Bulk Product to Solvay at least [*] prior to the
dates for delivery agreed between COR and Solvay according to Appendix 2 and
further specifying the delivery destination, which shall be noncancellable
except as provided in Section 2.8 below.
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
27
Solvay shall acknowledge in writing its receipt of and acceptance of a
shipping request placed pursuant to this Section 2.5 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 individual shipping
request from the same production lot.
2.6 Non-Conforming Product. Bulk Product supplied hereunder
shall be produced by Solvay in accordance with applicable laws and regulations
and Good Manufacturing Practices, to meet the Specification. COR may reject any
shipment of Bulk Product which is (a) not conforming with the Specification or
(b) adulterated or misbranded within the meaning of the United States Federal
Food, Drug and Cosmetic Act. Any notice of rejection of non-conforming Bulk
Product 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
Bulk Product is received, COR shall be deemed to have accepted such delivery of
Bulk Product.
After notice of rejection of non-conforming Bulk Product is given, COR
shall cooperate with Solvay in determining whether rejection is necessary or
justified. Solvay shall notify COR as promptly as reasonably possible whether or
not it accepts COR's basis for any rejection. If Solvay disagrees with COR's
determination that certain Bulk Product does not meet the Specification, such
Bulk 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 Bulk Product meets the Specifications 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 Bulk Product, Solvay shall, at COR's
request, use its best efforts to replace such rejected Bulk Product. Bulk
Product can only be reprocessed in accordance with validated reprocessing
procedures described in the drug master file, as agreed by the Parties.
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
28
Unless Solvay requests the destruction of rejected Bulk Product within
[*] of receipt of COR's notice of rejection of non-conforming Bulk 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 Bulk Product promptly
and provide Solvay with certification of such destruction.
2.7 Shipment. Solvay shall ship to a destination specified by
COR air Bulk Product ordered by COR by the agreed delivery dates. Bulk Product
will be labeled and packed according to the Specification. In the event that COR
specifies that the Bulk Product shall be shipped to a location other than COR's
principal offices (e.g., to a different location [*]) 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 or not later than concurrently with
the shipment of the Bulk Product. Except as provided herein with respect to
non-conforming Bulk Product, title and risk of loss as to all materials shipped
shall pass [*]. Solvay shall assist COR in arranging [*]. A packing list and a
certificate of analysis will be provided to COR for every shipment.
2.8 Purchase Cancellation. COR, on notice to Solvay, may cancel
any or all outstanding shipments only to the extent materials have not been
produced for such shipments. At any time, should COR cancel all outstanding
shipments other than by termination of this Agreement pursuant to Section 4.2,
COR agrees [*]. In the event that cancellation occurs after COR has paid Solvay
for Bulk Product Intermediates or for finished Bulk Product, COR shall be the
owner of such already-paid-for Bulk Product Intermediates and such finished Bulk
Product.
2.9 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.
2.10 Quality Control. Solvay shall manufacture Bulk Product
under this Agreement in conformity with the Specification, in a duly licensed
Peptisyntha facility as required by the United States Food and Drug
Administration or equivalent European Union
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
29
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
raw materials and/or components used to manufacture such Bulk Product and shall
maintain all appropriate validation documentation. 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 Section 2.10.
2.11 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 and shipment of the Bulk Product supplied hereunder.
Solvay shall give COR prompt notice of any impending inspections by a
governmental agency of the facility used for or processed involved in the
manufacture of Bulk Product, and provide COR an opportunity to observe such
inspection. Each Party shall promptly notify the other of new instructions or
specifications of which it becomes aware which are relevant to the manufacture
of Bulk Product under this Supply 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 or
distribution of Integrelin products, and will promptly notify COR of any
comments, responses or notices received from any governmental authorities which
relate to the regulatory status of Integrelin.
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
30
3.0 Price and Payments.
3.1 Price. COR shall pay to Solvay for the Bulk Product
purchased hereunder the amount set forth in Appendix 3, for Bulk Product in
accordance with the Specification of Appendix 1.
3.2 Initial and Intermediate Payments. Within thirty (30) days
of the Effective Date, COR shall pay to Solvay [*] which amount Solvay has
agreed will be committed to the purchase of raw materials for use in the
preparation of Bulk Product. Additionally, COR shall pay to Solvay [*] within
[*] days of the date on which Solvay notifies COR that Solvay has produced all
of the following intermediates fit for further processing into Bulk Product (or
such other level of production agreed in the Specification):
[*]
Ownership of such Bulk Product Intermediates shall pass to COR upon [*] by COR
to Solvay.
3.3 Method of Payment for Finished Bulk Product. Within [*]
after a shipment of Bulk Product pursuant to Section 2.7 above, Solvay shall
submit an invoice for the balance of payments attributable to that shipment of
Bulk Product to COR. All payments due hereunder to Solvay shall be paid to
Solvay in United States Dollars not later than [*] days following the acceptance
date of the applicable shipment, to such account of Solvay in such bank as
Solvay may from time to time designate by notice to COR, as provided in the
License Agreement.
3.4 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.
3.5 Process Improvement. It is understood by both Parties that
significant manufacturing cost reductions may be possible. The parties shall
discuss and agree on a mechanism by which the benefits of process improvements
to which COR contributed are equitably allocated to the Parties according to
their relative contribution to the improvements.
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
31
3.6 Overdue Payment. Payments provided for in this Section 3.0,
when overdue, shall bear an interest at a rate per annum equal to [*] effective
[*] and for the time period until payment is received by Solvay.
3.7 [*]. Without prejudice to any of Solvay's rights hereunder,
in the event that [*] COR agrees to [*] and [*].
4.0 Term and Termination.
4.1 Term. The term of this Supply Agreement shall commence on
the Effective Date and will continue, unless sooner terminated, for a period of
three (3) years.
4.2 Termination. This Supply Agreement may be terminated: (a)
upon mutual written agreement between the Parties; or (b) by either Party as a
result of a material default in the performance of any material agreement,
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.
4.3 Effect of Termination. The expiration or termination of this
Supply Agreement shall not relieve Solvay from its obligation to deliver Bulk
Product ordered by purchase orders received and accepted by Solvay prior to the
effective date of such expiration or termination, nor shall expiration or
termination relieve COR from accepting and, upon acceptance, paying for any such
Bulk Product. Expiration or termination shall not limit COR's right to sell
Integrelin produced from Bulk Product in its possession or delivered to it after
such expiration or termination. Unless expressly provided to the contrary, the
provisions of Sections 3.0, 4.3, 5.0, 6.1,6.6 and 6.10 shall survive the
expiration or termination of this Agreement.
5.0 Indemnification and Liability.
5.1 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:
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
32
(a) the use by or administration to any person of
Integrelin (except where such cost, claim, suit,
expense or damage arose or resulted from Solvay's
negligence or willful misconduct, or an event
specified in Section 5.2); or
(b) infringement of any third party intellectual
property rights relating to Integrelin;
provided that Solvay gives prompt notice 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.
5.2 Solvay Indemnification. Solvay shall indemnify COR for:
(a) any failure of the Bulk Product supplied by Solvay
under the Supply 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;
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.
5.3 Liability Cap. Other than for death or personal injury
caused by Solvay's negligent or willful acts, Solvay's liability to COR under
this Supply 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
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
33
Product or Bulk Product Intermediates used to manufacture the batch of Bulk
Product to be replaced and the manufacture of same was accurate.
5.4 Limitation of Liability. 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.
6.0 General Provisions.
6.1 Warranties. Solvay warrants:
(a) that it will comply with all manufacturing
instructions and the Specification, including
quality control standards provided in accordance
with Sections 1.2, 2.10 or 2.11;
(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 the
carrier, Bulk Product will be in conformity with
the Specification and with the United States Food,
Drug and Cosmetic Act, e.g., shall not be
adulterated or misbranded or otherwise of a nature
which may not be introduced into United States
interstate commerce.
6.2 No Other Warranties. The express warranties made in this
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.
6.3 Recalls. Solvay will indemnify and hold COR harmless from
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 Section 6.1 above. For purposes of this Agreement, the expenses of recall
shall be the expenses of notification and destruction or return
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
34
of the recalled Bulk Product, the costs of Bulk Product recalled and any costs
directly associated with the distribution of replacement Bulk Product. COR shall
have the right to control the arrangement of any recall, and the Parties will
cooperate with each other in implementing such recall.
6.4 Complaints. Solvay will report to COR in writing any
complaints and any information that it may receive relating to Integrelin.
6.5 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 by given by facsimile transmission (receipt
verified), telexed, mailed by registered or certified mail (return receipt
requested), postage prepaid, or sent by express courier service, properly
addressed to the address of the Party to be notified as shown below:
If to Solvay:
Peptisyntha & Cie, SNC
General Manager
000, xxx xx Xxxxxxxx
X-0000 Xxxxxxxxx, Xxxxxxx
If to COR:
President, COR Therapeutics, Inc.
00 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx, 00000 U.S.A.,
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.
6.6 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,
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. However, in
any event, Solvay agrees that COR's Bulk Product orders for 1995 and 1996 shall
be made in the existing Peptisyntha manufacturing facility. It is
10.
CONFIDENTIAL TREATMENT REQUESTED = [*]
35
recognized that Solvay may wish to pursue the manufacture of Bulk Product
Intermediates by a manufacturer other than Peptisyntha (such as the Solvay
Affiliate Solvay Duphar B.V.); the Parties agree to discuss in good faith
whether the possibility of such manufacturing activities would affect the
regulatory status of Integrelin. 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, provided such assignee or delegatee agrees to be bound
by the terms of this Supply Agreement.
6.7 Governing Law. This Agreement shall be governed by the laws
of England. Solvay and COR consent to the exclusive jurisdiction and venue of
the courts of England.
6.8 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 Supply Agreement by virtue of Force Majeure. In the event of Force Majeure,
the Party affected shall notify the other and shall attempt to perform its
obligations as soon as possible.
6.9 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.
6.10 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
11.
CONFIDENTIAL TREATMENT REQUESTED = [*]
36
name of the other or any other tradename or trademark 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 fact
that Solvay has contracted to furnish COR the goods and services herein ordered.
6.11 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.
6.12 Headings. All headings, titles and captions in this
Agreement are for convenience only and shall not be of any force or substance.
6.13 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.
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:
-------------------------------- --------------------------------------
Its: Its:
------------------------------- -------------------------------------
Appendix 1: Product Specification
Appendix 2: Shipping Schedule
Appendix 3: Bulk Product Price
12.
CONFIDENTIAL TREATMENT REQUESTED = [*]
37
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 1
BULK PRODUCT SPECIFICATION
I. Bulk Product content and testing
[*]
-----------------------------
[*]
13.
CONFIDENTIAL TREATMENT REQUESTED = [*]
38
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.
II. Shipping specification for shipment of Bulk Product to COR.
[*]
[*]
[*]
14.
CONFIDENTIAL TREATMENT REQUESTED = [*]
39
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 2
BULK PRODUCT SHIPPING SCHEDULE
[*]
-----------------------
[*]
15.
CONFIDENTIAL TREATMENT REQUESTED = [*]
40
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 3
BULK PRODUCT PRICE
COR shall pay to Solvay the amount of [*] for Bulk Product at the Specification.
16.
CONFIDENTIAL TREATMENT REQUESTED = [*]
41
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.
EXHIBIT C
ACCEPTABLE SECONDARY SOURCES
COR
[*]
17.
CONFIDENTIAL TREATMENT REQUESTED = [*]
42
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.
EXHIBIT D
CONFIDENTIALITY AGREEMENT
This Agreement is entered into effective as of ____ between
Solvay, Societe Anonyme ("Solvay"), a Belgian corporation, with its
principal offices at 00, xxx xx Xxxxxx Xxxxxx, 0000 Xxxxxxxxx, Xxxxxxx on behalf
of itself and its Affiliates;
COR Therapeutics, Inc. ("COR"), a Delaware corporation, with its
principal offices at 000 Xxxx Xxxxx Xxxxxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx,
00000, XXX, on behalf of itself and its Affiliates; and
_________________________________________________________ ("Company").
WITNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and know-how
relating to a product called Integrelin(TM);
WHEREAS, Solvay has developed a unique and valuable patented and
proprietary process useful for the manufacture of bulk peptide products
containing Integrelin(TM);
WHEREAS, Solvay is practicing the said process for the manufacture of
bulk peptide products containing Integrelin sold to COR pursuant to a License
and Supply Agreement entered into between Solvay and COR as of 27 July 1994:
WHEREAS, under the said License and Supply Agreement, COR is entitled to
establish, under certain conditions, a secondary source of supply for
manufacturing by practicing the said process and selling to COR bulk peptide
products containing Integrelin;
WHEREAS, under the said License and Supply Agreement, Solvay is
obligated to transfer its know-how and provide technical assistance to the
Company provided that the Company has entered into this confidentiality
agreement;
1.
CONFIDENTIAL TREATMENT REQUESTED = [*]
43
NOW THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the parties agree as follows:
1.0 Certain Definitions
For the purposes of this Confidentiality Agreement, the following terms
shall have the following meanings:
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 section 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 on the foregoing and for purposes of this
Agreement, Peptisyntha & Cie, Societe en Nom Collectif
("Peptisyntha"), which is a fully owned subsidiary of
Solvay and an entity existing under the laws of Belgium
and having its principal offices at 000, xxx xx Xxxxxxxx
- 0000 Xxxxxxxxx, Xxxxxxx, and also Solvay Duphar B.V.,
a Dutch corporation having its main office at X.X. van
Xxxxxxxxxx, 00, Xxxxx, Xxx Xxxxxxxxxxx, are deemed
Affiliates of Solvay.
1.2 "Agreement Purpose" shall mean the manufacture of Bulk
Product by the Company for supply to COR.
1.3 "Bulk Product" shall mean a bulk peptide product which
contains Integrelin, is produced by the Licensed Process
and is intended to undergo further processing,
formulation and/or vialing and packaging.
1.4 "Company Know-how" shall mean all information now or
hereafter in the possession of the Company, whether or
not patentable or disclosed within patents owned or
controlled by the Company, constituting materials,
methods, processes, techniques and data which are useful
or necessary for the manufacture of Bulk Product and
which relate to the Licensed Process
2.
CONFIDENTIAL TREATMENT REQUESTED = [*]
44
which the Company has the right to license or disclose
without violating existing contractual obligations to
third parties.
1.5 "Effective Date" shall mean ___________________.
1.6 "Integrelin" shall mean a specific peptide designated by
COR and known as Integrelin(TM), the chemical structure
of which is known to the parties because of prior
business relationships.
1.7 "Licensed Process" shall mean any process or process(es)
developed or acquired by Solvay presently or in the
future and used commercially for making bulk peptide
products containing Integrelin according to COR's
specifications, during the term of any supply
arrangements between COR and Solvay or the Company.
1.8 "Party" shall mean Solvay, COR or the Company.
1.9 "Solvay Know-how" shall mean all information now or
hereafter in the possession of Solvay, whether or not
patentable or disclosed within patents owned or
controlled by Solvay, constituting materials, methods,
processes, techniques and data which are useful [*] for
the manufacture of Bulk Product and which relate to the
Licensed Process which Solvay has the right to license
or disclose without violating existing contractual
obligations to third parties.
2.0 KNOW-HOW AND TECHNICAL ASSISTANCE
2.1 Transfer of Solvay Know-how to the Company. Promptly
upon execution of this Agreement, and updated at least
quarterly, Solvay shall provide to the Company in a
written form, [*] Solvay Know-how useful for the
manufacture of Bulk Product, including by way of
example, [*] and any documents which result from
inspection by governmental agencies [*]. Solvay shall
disclose such [*]. During the term of this Agreement,
Solvay shall continue to provide such technical
assistance and access to
3.
CONFIDENTIAL TREATMENT REQUESTED = [*]
45
information, as may be useful for the Company to
manufacture Bulk Product by the Licensed Process and to
support COR's efforts to obtain appropriate regulatory
approvals for the sale of products containing
Integrelin.
The Company agrees that such Solvay Know-how shall be
distributed by the Company only to those employees
designated by the Company as having a need to know such
information, and who sign personal obligations of
confidentiality with Solvay with respect to Solvay
Confidential Information. The Company further agrees to
guarantee such personal obligations of confidentiality
made by its employees
2.2 Transfer of Company Know-how to Solvay. During the term
of this Confidentiality Agreement, the Company shall at
least quarterly and promptly disclose the Company
Know-how to Solvay at a level of detail sufficient to
enable Solvay to practice the Company Know-now and shall
provide such technical assistance and access to
information as may be useful for Solvay to manufacture
Bulk Product and to support COR's efforts to obtain
appropriate regulatory approvals for the sale of
products containing Integrelin.
2.3 Transfer of Solvay Know-how and Company Know-how to COR.
During the term of this Confidentiality Agreement, the
Company may provide to COR in a written form, [*] Solvay
Know-how and [*] Company Know-how [*] useful [*] for
obtaining appropriate regulatory approvals [*] including
by way of example, [*] and any documents which result
from inspection by governmental agencies [*].
Such information shall be deposited by the Company to a
third party escrow acceptable to COR, Solvay and the
Company, in English language written form. Such escrow
of additional technical information shall be updated at
least quarterly by the Company. Access to this escrowed
information may be made by Solvay upon judicial order or
by agreement
4.
CONFIDENTIAL TREATMENT REQUESTED = [*]
46
between COR and Solvay. Access to this escrowed
information may be made by [*]. Any information received
by COR from the Company pursuant to this Section 2.3
shall be deemed Solvay Confidential Information for the
purposes of the License and Supply Agreement entered
into between Solvay and COR as of 27 July 1994.
3.0 CONFIDENTIALITY
3.1 Confidentiality and Exceptions. In the course of the
performance of this Confidentiality Agreement, one Party
may disclose to the other or receive information from
another Party relating to the subject matter of this
Agreement which information, if so identified upon
disclosure, shall be considered to be the disclosing
Party's Confidential Information. Each Party agrees that
it will take the same steps to protect the
confidentiality of another Party's Confidential
Information as it takes to protect its own proprietary
and confidential information. Each Party shall protect
and keep confidential and shall not use, publish or
otherwise disclose to another Party or to any third
party, except as permitted by this Agreement, without
the disclosing Party's written consent, the disclosing
Party's Confidential Information. For the purposes of
this Agreement, Confidential Information shall not
include such information that:
(a) was already known to the receiving Party, other
than under an obligation of confidentiality, at
the time of disclosure by the disclosing Party;
(b) was generally available to the public or was
otherwise part of the public domain at the time
of disclosure or became generally available to
the public or otherwise part of the public
domain after disclosure other than through any
act or omission of the receiving Party in breach
of this Agreement; or
(c) was lawfully disclosed to the receiving Party,
other than under an obligation of
confidentiality, by a third party who had no
5.
CONFIDENTIAL TREATMENT REQUESTED = [*]
47
obligation to the disclosing Party not to
disclose such information to others.
3.2 Authorized Disclosure. Each Party may disclose
Confidential Information hereunder to the extent such
disclosure is reasonably necessary for prosecuting or
defending litigation, complying with applicable
governmental regulations or conducting preclinical or
clinical trials, provided that if a Party is required by
law or regulation to make any such disclosure of another
Party's Confidential Information it will, except where
impracticable for necessary disclosures, for example in
the event of medical emergency, give reasonable advance
notice to that other Party of such disclosure
requirement and will use its reasonable efforts to
secure confidential treatment of such Confidential
Information required to be disclosed. In addition, COR
and Solvay shall be entitled to disclose, under a binder
of confidentiality containing provisions as protective
as those of this Section 3.0, the Company's confidential
Information to other entity permitted to practice the
License Process. No Party shall disclose Confidential
Information of another Party in any patent filings
without the prior written consent of the disclosing
Party.
3.3 Limitation on use. The Parties shall not use the
Confidentiality Information of any other Party disclosed
herein for any purpose other than the Agreement Purpose.
4.0 TERMINATION.
4.1 Term. This Confidentiality Agreement shall become
effective on the Effective Date and, unless terminated
earlier under Section 4.2 or 4.3, shall remain in effect
until termination of the supply arrangements between COR
and the Company.
4.2 Termination.
6.
CONFIDENTIAL TREATMENT REQUESTED = [*]
48
(a) If the Company shall default in a material
manner with respect to any material provision of
this Agreement and Solvay or COR shall have
given the Company and the other Party notice of
such default, the Company shall have ninety (90)
days to cure such default. If such default is
not cured within such ninety (90) day period,
the nondefaulting Parties shall have the right,
upon notice to the Company and without prejudice
to any other rights they may have, to terminate
this Agreement unless the Company is in the
process of attempting in good faith to remedy
such default, in which case the ninety (90) day
cure period shall be extended by an additional
sixty (60) days;
(b) If the Company makes any assignment of
substantially all of its assets for the benefit
of creditors, or places substantially all of its
assets in the hands of a receiver or judicial
manager unless the receivership or judicial
management is dissolved within thirty (30) days
thereafter, goes into liquidation, or is
dissolved, wound up, confiscated, sequestered or
in any other way transferred into state
ownership, then COR or Solvay may terminate this
Agreement forthwith upon ten (10) days written
notice to the Company.
4.3 Survival of Certain Provisions. The provisions of
Section 3.0 shall survive any termination of this
Confidentiality Agreement until [*].
5.0 GENERAL PROVISIONS
5.1 Liability. Solvay makes no representation nor warranty
and, other than for death or personal injury caused by
Solvay's negligent or willful acts, shall have no
liability whatsoever to COR, the Company or any third
party for or on account of any injury, loss or damage,
of any kind or nature, sustained by, or any damage
assessed or asserted against, or any other liability
incurred or imposed upon COR, the Company or any third
party, arising out of or in connection with or resulting
from the execution,
7.
CONFIDENTIAL TREATMENT REQUESTED = [*]
49
delivery and performance of this Confidentiality
Agreement and the Company shall hold Solvay and its
officers, agents and employees harmless in the event
Solvay, its officers, agents or employees are held
liable.
5.2 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 by given by facsimile transmission
(receipt verified), telexed, mailed by registered or
certified mail (return receipt requested), postage
prepaid, or sent by express courier service, properly
addressed to the address of the Party to be notified as
shown below:
If to Solvay:
Solvay, S.A.
Head of Licensing Department
Xxx xx Xxxxxx Xxxxxx, 00
X-0000 Xxxxxxxxx. Belgium
If to COR:
President, COR Therapeutics, Inc.
000 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx, 00000 U.S.A.,
If to the Company:
or to such other address as to which any Party may notify the
others. 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.
5.3 Assignment and Delegation. The Company may not assign
its rights and/or delegate its obligations under this
Agreement to any third party
8.
CONFIDENTIAL TREATMENT REQUESTED = [*]
50
without the prior consent of COR and Solvay. Solvay and
COR may assign their rights and/or delegate their
obligations under this Agreement to any third party
without the consent of the Company.
5.4 Governing Law. This Agreement shall be governed by the
laws of England. Solvay, the Company and COR consent to
the exclusive jurisdiction and venue of the courts of
England.
5.5 Amendment. No amendment or modification of the terms of
this Agreement shall be binding any Party unless reduced
to writing and signed by the respective authorized
officers of the Parties.
5.6 Publicity. The Parties agree that, except as may
otherwise be required by applicable laws, regulations,
rules, or orders, no information concerning this
Agreement and the transactions contemplated herein shall
be made public by any Party without the prior written
consent of the others.
5.7 Waiver. Failure of any Party to insist upon strict
observance of or compliance with any of the terms of
this 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.
5.8 Counterparts. This Agreement may be executed in multiple
counterparts, each of which shall be an original, but
all of which shall constitute but one agreement.
9.
CONFIDENTIAL TREATMENT REQUESTED = [*]
