1
EXHIBIT 10.29
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.
AMENDMENT NO. 4 TO
THE LICENSE AND SUPPLY AGREEMENT
BETWEEN COR THERAPEUTICS, INC.
AND
SOLVAY, S. A.
THIS AMENDMENT NO. 4 to the License and Supply Agreement (the
"Amendment") is entered into 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,
0000 Xxxxxxxxx, Xxxxxxx, each on behalf of itself and its Affiliates. This
Amendment shall be effective on April 1, 1997 (the "Amendment Effective Date").
RECITALS
WHEREAS, COR and Solvay entered into a License and Supply Agreement
dated 27 July 1994 (the "License and Supply Agreement") and a Long Term Supply
Agreement dated 28 September 1995 (the "Long Term Supply Agreement") to provide
for the manufacture of a bulk peptide product and for the supply of that product
to COR for commercial and clinical use; and
WHEREAS, Solvay has agreed that COR may utilize [*] on certain terms;
and
WHEREAS, the Parties desire to clarify certain matters related to the
transfer of technology and communications between the Parties.
NOW THEREFORE, in consideration of the foregoing and the covenants and
promises contained in this Amendment, COR and Solvay hereby amend the License
and Supply Agreement as follows.
In this Amendment, capitalized terms shall have the meanings provided
herein or otherwise provided by the License and Supply Agreement. Headings are
for the convenience of the Parties only, and shall not be of any force or
substance.
1. Section 1.7 shall be deleted and replaced with the following:
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1.7 "INTEGRILIN" shall refer to a specific peptide designated by COR and
known as Integrilin(TM), which same peptide was known previously as
"Integrelin", the chemical structure of which is known to Solvay because of the
prior business relationship between COR and Solvay. Any references herein to
Integrelin shall be deemed to refer to Integrilin.
2. Section 1.9 shall be deleted and replaced with the following:
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 [*] or 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
(d) any charges for freight or insurance in a CIF sale.
3. Section 1.13 shall be inserted after Section 1.12 as follows:
1.13 "STEP ONE INTERMEDIATES" shall refer to those Bulk Product
Intermediates, [*] which exist upon completion of the manufacture of Bulk
Product through a certain step (designated by the Parties as "Step One").
4. Section 2.2 shall be deleted and replaced with the following:
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 [*] would be acceptable
as the Secondary Source. COR will notify Solvay of the establishment of the
Secondary Source. In the event COR terminates a supply arrangement with a
Secondary Source, COR may establish an alternate Secondary
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Source. COR shall notify Solvay within [*] of such a termination of supply
arrangements with a Secondary Source. Further, after the Secondary Source is
established, COR may use [*]. COR's future requirements for Bulk Product [*] COR
wants to entertain certain [*]. Therefore, after the Secondary Source is
established, COR shall [*] purchase from Solvay [*] 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 produce 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 [*] of its requirements in
the event of any breach or default of Solvay of any supply arrangement between
COR and Solvay, for so long as the breach or default remains uncured. [*] 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 [*].
5. Section 3.1 shall be deleted and replaced with the following:
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 if COR is
the Secondary Source and/or Back-up Secondary Source, or have manufactured by
the Secondary Source and/or Back-up Secondary Source [*] Integrilin and products
containing Integrilin produced practicing the Solvay Know-how or the Licensed
Process. In addition, Solvay hereby grants to COR the right, within the
foregoing license, to [*] to have Bulk Product manufactured by [*] for COR
produced by practicing the [*] Solvay Know-how or the Licensed Process, [*]. No
other rights than those expressly provided in this Agreement, the Long Term
Supply 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
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term of this Agreement under the Solvay Patents and Solvay Know-how to
manufacture bulk peptide products containing Integrilin or to use or sell Bulk
Products manufactured thereby.
6. Section 3.3 shall be deleted and replaced with the following:
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 in any [*]. Any such improvements developed or acquired
by Solvay which are used commercially by Solvay or [*] and/or the Secondary
Source and/or Back-up Secondary Source for making bulk peptide products
containing Integrilin 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 use [*] and/or to
establish a Secondary Source (and/or Back-up Secondary Source) only if it 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 [*] or such Secondary Source, to develop, use, sell,
have sold, [*] or have manufactured by [*] and/or the Secondary Source (and/or
Back-up Secondary Source) [*] of this Agreement, Integrilin and products
containing Integrilin.
However, for [*] the Secondary Source established by COR pursuant to
Section 2.2 of this Agreement, any sublicense to [*] those improvements which
are developed or acquired by Solvay upon or after [*] and whose use in the
Licensed Process would have a significant impact on the economics of the
practice of the Licensed Process or on the quality of the products produced
thereby, and such improvements [*].
COR hereby agrees to sublicense the rights granted to it pursuant to
this Section 3.3 by [*] or 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 [*] or Secondary Source
improvements to manufacture Bulk Product [*] is the Secondary
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Source, [*] COR [*] or 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 [*] or any Secondary Source, whether or not the
exchange of improvements should be continued [*].
In the event that COR [*], 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-how 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
Integrilin and products containing Integrilin, 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 [*].
7. Section 3.5 shall be deleted and replaced with the following:
3.5 Technology Transfer to the Secondary Source. Promptly upon the
notification by COR to Solvay of the planned commencement of Bulk Product
manufacture by [*] for COR, or 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, and to [*] if applicable, 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
[*] and/or the Secondary Source to manufacture Bulk Product by the Licensed
Process and to obtain appropriate regulatory approvals for the sale of products
containing Integrilin.
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COR shall require [*] and the Secondary Source to agree that such Solvay
Know-how shall be distributed by [*] and/or the Secondary Source only to those
employees designated by [*] and/or 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 [*]
and the Secondary Source to further agree to guarantee such personal obligations
of confidentiality made by its employees, respectively.
8. Section 3.7 shall be inserted after Section 3.6 as follows:
3.7 TECHNOLOGY TRANSFER AGENTS. Solvay agrees that COR may designate [*]
Technology Transfer Agents ("TTAs"). The mission of the TTAs shall be to
participate in the technology transfer team appointed to transfer the Solvay
Know-How to [*] [*] or a Secondary Source established pursuant to Section 2.2 of
this Agreement (the "Mission"). The Mission shall terminate on the earlier of
either the production under appropriate regulatory approvals related to
manufacturing by [*] and the Secondary Source of an aggregate amount of [*] of
Bulk Product for COR [*] or [*] of the supply, to [*] or to the Secondary Source
pursuant to Section 3.5 of this Agreement, of an initial disclosure package in a
written form which would include:
[*]
In the event that COR entrusts its Secondary Source, [*] with the
manufacture for COR of [*] the Mission shall be reactivated and shall terminate
again on the earlier of either the production under appropriate regulatory
approvals related to manufacturing by [*] of an aggregate amount of [*] of Bulk
Product for COR [*] or [*] of the supply in a written form of the initial
disclosure package described above - to [*] pursuant to Section 3.5 of this
Agreement.
In the event that an alternate Secondary Source is established pursuant
to Section 2.2 of this Agreement, the Mission shall be reactivated and shall
terminate again on the earlier of either the production under appropriate
regulatory approvals related to manufacturing by such Secondary Source of an
aggregate amount of [*] of Bulk Product for COR [*] or [*] of the supply in a
written form of the initial disclosure package described above to such Secondary
Source pursuant to Section 3.5 of this Agreement.
SOLVAY shall disclose promptly to the TTAs all information sufficient to
enable them to complete the Mission. Each TTA will be under confidentiality
obligations to SOLVAY in accordance with the Confidentiality Agreement given in
Exhibit E. The persons utilized as
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TTAs may be changed by COR with the prior written approval of Solvay, such
approval not to be unreasonably delayed or withheld.
9. Section 4.9 shall be deleted and replaced with the following:
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 [*] or 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 [*] or the Secondary Source [*] upon invoice, with supporting
documentation, from Solvay.
10. Section 6.7 shall be deleted and replaced with the following:
6.7 Performance by Secondary Source. COR shall remain responsible
and be guarantor of the performance by [*] or the Secondary Source under this
Agreement and the Supply Agreement and shall cause [*] or the Secondary Source
to comply with the provisions of this Agreement and the Supply Agreement in
connection with such performance.
11. Section 8.2 shall be deleted and replaced with the following:
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 [*]
or any Secondary Source permitted under Sections 2.2 and 3.0 of this Agreement.
Nothing in this
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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.
12. Section 8.5 shall be deleted and replaced with the following:
8.5 Confidentiality and Limitation on Use COR agrees, and shall
require [*] and the 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 [*] and 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.
13. Except as otherwise amended herein, the License and Supply Agreement
shall remain in full force and effect.
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IN WITNESS WHEREOF, the Parties hereto have executed this Amendment to
be effective on the date set forth above.
COR THERAPEUTICS, INC. SOLVAY, S.A.
By: By:
-------------------------------- --------------------------------
Title: Title:
----------------------------- -----------------------------
Exhibit E: Technology Transfer Agent Confidentiality Agreement
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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.
CONFIDENTIALITY AGREEMENT
This Agreement is entered into effective as July 16, 1996
among:
SOLVAY, Societe Anonyme ("SOLVAY"), a Belgian corporation,
with its principal offices at 00, xxx xx Xxxxxx Xxxxxx, 0000
Xxxxxxxx, Xxxxxxx, on behalf of itself and its Affiliates; and
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
[*] ("RECIPIENT"), a designee of COR with an address at [*]
USA.
WITNESSETH:
WHEREAS, COR owns certain patent rights, trademarks and
know-how relating to a product called INTEGRILIN(TM),
WHEREAS, SOLVAY has developed a unique and valuable patented
and proprietary process useful for the manufacture of
peptides, and is practising the said process for the
manufacture of bulk peptide products containing INTEGRILIN(TM)
sold to COR pursuant to several Agreements entered into
between SOLVAY and COR,
WHEREAS, SOLVAY has agreed to disclose confidential
information relating to its process to RECIPIENT, who has been
duly appointed by COR to participate in technology transfer
team in charge of the transfer of SOLVAY's technology to COR's
Secondary Source of supply of INTEGRILIN(TM) and to [*] the
production of bulk peptide products containing INTEGRILIN(TM)
for the account of SOLVAY.
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:
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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 Xxxxxxxx,
Xxxxxxx, is deemed an Affiliate of SOLVAY.
1.2. "Agreement Purpose" shall mean the participation of
RECIPIENT in the technology transfer team appointed
to Transfer SOLVAY's technology to COR's Secondary
Source of supply and [*]
1.3 "SOLVAY Confidential Information" shall mean any or
all confidential information relating to the process
developed by SOLVAY for the manufacture of bulk
peptide products containing INTEGRILIN(TM).
1.4. "Effective Date" shall mean 07/16, 1996.
1.5. "INTEGRILIN(TM)" shall mean a specific peptide
designated by COR and known as INTEGRILIN(TM), the
chemical structure of which is known to the Parties
pursuant to the terms of separate agreements entered
into with COR.
1.6. "Party" shall mean SOLVAY, COR or RECIPIENT.
2.0. DISCLOSURE OF SOLVAY CONFIDENTIAL INFORMATION
2.1. SOLVAY shall disclose to RECIPIENT SOLVAY
Confidential Information sufficient to enable
RECIPIENT to fulfil the Agreement Purpose.
2.2 SOLVAY Confidential Information disclosed under
paragraph 2.1 hereabove may be disclosed in tangible
form, such as in writing and marked "Confidential",
or provided
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orally. SOLVAY confidential Information must be indicated to
be confidential at the time of its first disclosure to
RECIPIENT.
3.0. CONFIDENTIALITY AND EXCEPTIONS
3.1. RECIPIENT hereby agrees, regarding SOLVAY Confidential
Information, that he/she shall:
(a) make no use of said information, except for the Agreement
Purpose;
(b) not disclose said information to any party or person other
than a possible second person appointed by COR to fulfil the
Agreement Purpose and who shall have signed a confidentiality
agreement similar to this Agreement;
(c) not disclose said information to COR;
(d) not disclose to any party or person either the existence
of this Agreement or its underlying discussions except for the
Agreement Purpose;
(e) take the same steps to protect said information as he/she
takes to protect the proprietary and confidential information
of COR.
3.2. The obligations under paragraph 3.1 hereabove shall not,
however, apply to any SOLVAY Confidential Information which:
(a) RECIPIENT can prove is at the time of disclosure or
thereafter becomes public knowledge through no fault or
negligence of RECIPIENT, or
(b) RECIPIENT can prove was known to him/her, prior to the
receipt of such Confidential Information from SOLVAY, or
(c) is lawfully obtained by RECIPIENT from any party not bound
by a secrecy obligation towards SOLVAY relating to the
Confidential Information.
For the purposes of this paragraph 3.2, information shall not be deemed
to be public knowledge or known on the ground only that:
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(i) the general principle is public knowledge or known to
RECIPIENT if the particular practice is not itself public
knowledge or so known, or
(ii) it constitutes a combination of or is drawn from
information which is public knowledge or known to RECIPIENT
unless the combination itself and its principle and mode of
operation is also public knowledge or known to the RECIPIENT.
4.0. DOCUMENTS DELIVERY OR DESTRUCTION
Upon the written request of SOLVAY, RECIPIENT undertakes to
promptly deliver it, or destroy if so instructed by it, all
documents furnished by SOLVAY to RECIPIENT and constituting
Confidential Information, as well as all copies thereof which
might be in his/her possession.
5.0. NO IMPLIED LICENSE
Nothing in this Agreement shall be construed as to grant
RECIPIENT any title or right or license to own or use at any
time the SOLVAY Confidential Information, except as expressly
set forth herein.
6.0. COR'S RESPONSIBILITY
COR shall guarantee the performance of this Agreement by
RECIPIENT.
7.0. TERM
This Agreement shall become effective on the Effective Date
and shall remain in effect for six (6) months. The provisions
of Article 3 shall however survive until [*].
8.0. GENERAL PROVISIONS
8.1. 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 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:
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If to SOLVAY:
SOLVAY S.A.
DCR-LC
000, xxx xx Xxxxxxxx
X - 0000 Xxxxxxxx, Xxxxxxx
Attention General Manager Research and Development
If to COR:
President, COR Therapeutics, Inc.
000 Xxxx Xxxxx Xxxxxx
Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000, XXX
If to RECIPIENT:
[*]
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.
8.2. Assignment and Delegation
RECIPIENT may not assign his/her rights and/or delegate
his/her obligations under this Agreement to any third party
without the prior consent of SOLVAY and COR.
8.3. Amendment
No amendment or modification of the terms of this Agreement
shall be binding on any Party unless reduced to writing and
signed by the respective authorised officers of SOLVAY and COR
and by RECIPIENT.
8.4. 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.
8.5. Waiver
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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.
8.6. 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.
8.7 Governing Law
This Agreement shall be governed by the laws of England.
SOLVAY, COR and RECIPIENT consent to the exclusive
jurisdiction and venue of the Courts of England.
IN WITNESS THEREOF, the parties hereto have executed this
Agreement, in three original copies.
SOLVAY S.A. COR THERAPEUTICS, INC.
By: By:
-------------------------------- --------------------------------
Title: Title:
----------------------------- -----------------------------
RECIPIENT
[*]
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