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Exhibit 10.36
AMENDMENT NO.1
TO THE AGREEMENT
BETWEEN
COR THERAPEUTICS, INC.
AND
XXX XXXXX AND COMPANY
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TABLE OF CONTENTS
Amended Agreement Section Page
------------------------- ----
2.14a "COR Option Product" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.15a "COR Product" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.21a "First Human Dose" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.2lb "Generically Equivalent Product" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.26a "Lilly Product" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.32 "Patent Right" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2.44a "Specific PAI Agent" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.44b "Specific New Chemistry Compound" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
2.45a "Terminated Co-Development Products" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.1a Membership of Steering Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.4a Membership of Operating Committees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.5 Information and Reports Following the Research Term . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.5a COR Information and Reports Following the Research Term . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.5b Development of Specific New Chemistry Compounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.5c Development of Specific PAI Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.5d Responsibilities of Agreed Third Party . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
5.11 Termination of Certain Development Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.8 Commercialization of Non Co-Developed Products by Lilly . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.9 Commercialization of Non Co-Developed Products by COR . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
9.9 cGMP Compliance and QA Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
13.7 Additional Payment by Lilly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
13.8 Additional Payment by COR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
13.19 Royalty on Products Developed by COR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
13.20 Royalty on Lilly Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
14.5 Terminated Co-Development Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
14.6 COR Option Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
14.7 COR Products and Specific New Chemistry Compounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
14.8 Lilly Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
15.1 Patentable Inventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
15.9 Litigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
15.10 Enforcement of Lilly Patent Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
16.1 Licenses to COR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
16.2 Licenses to Lilly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
16.3 Disclosure of Information by Lilly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
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TABLE OF CONTENTS
(continued)
16.4 Disclosure of Information by COR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
16.5 Transfer of IND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
16.6 Transfer of USAN Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
16.7 No Assurances Under Third Party Intellectual Property Rights . . . . . . . . . . . . . . . . . . . . . . . . 21
17.1 Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
17.2 Publicity Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
19.1 Indemnification by Lilly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
19.3 Indemnification by COR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
APPENDICES
APPENDIX 1 - [*]
APPENDIX 2 - [*]
APPENDIX 3 - [*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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AMENDMENT NO.1
TO THE AGREEMENT
BETWEEN
COR THERAPEUTICS, INC.
AND
XXX XXXXX AND COMPANY
THIS AMENDMENT No.1 is entered into as of the 18 day of November,
1996, ("Amendment Effective Date") by and between COR THERAPEUTICS, INC., a
Delaware corporation ("COR") and XXX LILLY AND COMPANY, an Indiana corporation
("Lilly").
RECITALS
WHEREAS, COR and Lilly entered into a Research, Option, and License
Agreement dated May 1, 1991 (the "Original Agreement") for the research,
development, and commercialization of certain platelet aggregation inhibitor
agents that was superseded and terminated by a Collaboration Agreement
effective May 28, 1993, (the "Agreement"); and
WHEREAS, COR exercised its right to extend the Research Term until
April 30, 1996; and
WHEREAS, Lilly elected to terminate its rights to develop certain
Collaboration Compounds; and
WHEREAS, under this Amendment, the parties (i) confirm their
respective rights to perform continuing research and development within the
field of Collaboration Compounds (and, with respect to certain categories of
compounds, for COR to have the right to do so in collaboration with a third
party effective immediately and Lilly to have the right to do so in
collaboration with a third party effective [*]), and (ii) allocate to each other
[*] to commercialize [*] within the category of Collaboration Compounds; and
WHEREAS, in particular, under this Amendment, COR has [*] to: (a) [*]
as to which Lilly terminated co-development under the original Agreement (as
defined below, the "Terminated Co-Development Products"), (b) [*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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[*] Specific PAI Agents (as defined below) that COR designates prior to [*] (as
defined below, the "COR Option Products"), and (c) any additional Specific PAI
Agents which involve [*] (these are particular "Specific New Chemistry
Compounds", as defined below). Effective [*] either COR or Lilly can receive
exclusive rights to other Specific PAI Agents by [*] of the compound in
question (these products being referred to herein as "COR Products" and "Lilly
Products", respectively). All Collaboration Compounds other than Specific PAI
Agents remain subject to the existing terms of the Agreement (i.e., with each
of COR and Lilly retaining rights of co-development, co-promotion, etc.).
Compounds which are not within the definition of Collaboration Compounds under
the Agreement remain outside the scope of the Agreement; and
WHEREAS, in addition to the foregoing, this amendment clarifies
certain matters related to the termination of the Parties' collaborative
research.
NOW, THEREFORE, in consideration of the foregoing and the covenants
and promises contained in this Amendment, COR and Lilly hereby amend the
Agreement as follows:
1. Section 2.14a shall be inserted following Section 2.14 as follows:
2.14a "COR OPTION PRODUCT" means a Specific PAI Agent which is
designated by COR pursuant to Section 4.5a and [*] such compounds at any time.
As used herein, (i) [*] which have the [*] shall be treated as a [*] and (ii)
the designation of the [*] COR Option Product shall include [*]. Upon
designation by COR, a COR Option Product shall be excluded from the definitions
of Collaboration Compound and Product.
2. Section 2.15a shall be inserted following Section 2.15 as follows:
2.15a "COR PRODUCT" means a Specific PAI Agent to which COR obtains
exclusive rights on or after [*] by designation pursuant to Section 4.5c. As
used herein, (i) [*] which have the [*] shall be treated as a [*] and (ii) the
designation of the [*] COR Product shall include [*]. COR Products designated
pursuant to Section 4.5c shall be excluded from the definitions of
Collaboration Compound and Product.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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3. Section 2.21a shall be inserted following Section 2.21 as follows:
2.21a "FIRST HUMAN DOSE" means the first dose administered to a
human subject according to a clinical plan consistent with the dosing company's
regular practice for clinical trials designed to support regulatory approval in
any country.
4. Section 2.2lb shall be inserted following Section 2.21 as follows:
2.21b "GENERICALLY EQUIVALENT PRODUCT" means a product containing
the same active specie as a Product, Lilly Product, COR Product, COR Option
Product, Specific New Chemistry Compound, or a Terminated Co-Development
Product, the making, using or selling of which (i) is not authorized by COR or
by Lilly as applicable and (ii) either (a) cannot be prevented or stopped by
COR or by Lilly, relying on the COR Patent Rights or Lilly Patent Rights, after
negotiation or adjudication to a court of final resort, or (b) in the exercise
of the Patent owner's reasonable judgment, would not be prevented or stopped by
negotiation or adjudication.
[*] shall not be deemed Generically Equivalent Products.
5. Section 2.26a shall be inserted following Section 2.26 as follows:
2.26a "LILLY PRODUCT" means those Specific PAI Agents to which Lilly
obtains exclusive rights after [*] by designation pursuant to Section 4.5c. As
used herein, (i) [*] which have the [*] shall be treated as a [*] and (ii) the
designation of the [*] a Lilly Product shall include [*]. Lilly Products
designated pursuant to Section 4.5c shall be excluded from the definitions of
Collaboration Compound and Product.
6. Section 2.32 shall be deleted in its entirety and shall be replaced
with the following:
2.32 "PATENT RIGHT" means a patent or patent application, and all
divisions, continuations, continuations in part, reissues, extensions and
foreign counterparts thereof, and supplemental protection certificates related
thereto, that is owned or controlled by COR or by Lilly and is based on an
invention made on or before the end of the Research Term, at least one claim of
which covers the making, using or selling of a Collaboration Compound.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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7. Section 2.44a shall be inserted following Section 2.44 as follows:
2.44a "SPECIFIC PAI AGENT" means a [*] which has an [*] as measured
by [*] assays described in Appendix 1 and either (i) is conceived, discovered,
synthesized or developed by COR or Lilly and is within the scope of a claim of
a patent or patent application (or any division, continuation,
continuation-in-part, reissue, extension or foreign counterpart thereof) that
is based on an invention which is reduced to practice prior to the end of the
Research Term or (ii) as to which rights were acquired by COR or Lilly from a
third party prior to [*] on an absolute or contingent basis. As used herein, an
invention of a Specific PAI Agent shall have been "reduced to practice" if any
compound within any claim of the patent or patent application covering such
invention has been synthesized or otherwise made and shown to be a [*]. As
used herein, (i) [*] which have the [*] shall be treated as a [*] and (ii) the
designation of the [*] as a Specific PAI Agent shall include [*]. As used
herein, [*].
8. Section 2.44b shall be inserted following Section 2.44a as follows:
2.44b "SPECIFIC NEW CHEMISTRY COMPOUND" means a Specific PAI Agent,
which compound (i) [*] and (ii) either (a) is conceived, discovered,
synthesized or developed by COR and is within the scope of a claim of a patent
or patent application (or any division, continuation, continuation-in-part,
reissue, extension or foreign counterpart thereof) that is based on an
invention which is reduced to practice between [*] and [*] or (b) as to which
rights were acquired by COR from a third party between [*] and [*], on an
absolute or contingent basis. As used herein, an invention of a Specific New
Chemistry Compound shall have been "reduced to practice" if any compound within
any claim of the patent or patent application covering such invention has been
synthesized or otherwise made and shown to be a [*]. As used herein, (i) [*]
which have the [*] shall be treated as a [*] and (ii) the designation of the
[*] as a Specific New
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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Chemistry Compound shall include [*]. Specific New Chemistry Compounds
designated for development pursuant to Section 4.5b shall be excluded from the
definitions of Collaboration Compound and Product.
9. Section 2.45a shall be inserted following Section 2.45 as follows:
2.45a "TERMINATED CO-DEVELOPMENT PRODUCTS" means [*]. As used
herein, (i) [*] which have the same active specie shall be treated as [*] (ii)
the designation of the [*] as a Terminated Co-Development Product shall include
[*], and (iii) the [*] shall include the [*] and [*]. Terminated Co-Development
Products are excluded from the definitions of Collaboration Compound and
Product.
10. Section 0.xx shall be inserted following Section 3.1 as follows:
3.1a MEMBERSHIP OF STEERING COMMITTEE. Following the Amendment
Effective Date, the Steering Committee shall no longer operate as a committee,
and decisions reserved to such committee shall be made by mutual agreement of
the Vice President of Cardiovascular Research of Lilly and the Vice President
of Research of COR, or the designee of each of them.
11. Section 3.4a shall be inserted following Section 3.4 as follows:
3.4a MEMBERSHIP OF OPERATING COMMITTEES. Following the Amendment
Effective Date, any Operating Committee shall no longer operate as a committee,
and decisions reserved to such committee shall be made by mutual agreement of
the Vice President of Cardiovascular Research of Lilly and the Vice President
of Research of COR, or the designee of each of them.
12. Section 4.5 shall be deleted in its entirety and shall be replaced
with the following:
4.5 INFORMATION AND REPORTS FOLLOWING THE RESEARCH TERM. Subject
to Sections 4.5a, 4.5b, 4.5c and 4.5d, at any point following the Research Term
that a Party believes a Collaboration Compound should be designated for
development, it shall submit such recommendation, together with all available
Information regarding such Collaboration Compound, to the Operating Committee
pursuant to Section 5.1 for a determination of whether such compound should be
selected for development as a
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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Product. If the Operating Committee does not select such compound for
development, the Party desiring to develop such compound may proceed with
development, if it desires to do so, pursuant to Section 5.10 (including the
re-offer and royalty provisions contained therein) and shall notify the other
Party if such development is discontinued. Submission by a Party of a
recommendation for development under this Section 4.5 shall preclude the other
Party from subsequently designating such Collaboration Compound for development
under Sections 4.5a, 4.5b, or 4.5c, during the time period such Collaboration
Compound is being actively developed as a Co-Developed Product or under Section
5.10.
13. Section 4.5a shall be inserted following Section 4.5 as follows:
4.5a COR INFORMATION AND REPORTS FOLLOWING THE RESEARCH TERM. At
any point before [*] that COR believes a Specific PAI Agent, [*] should be
designated for development as a COR Option Product, it shall notify Lilly and a
mutually agreed third party, in writing, of such designation. The notice to
Lilly shall include identification of the compound [*]. Subject to prior
designation of such compound for development under Section 4.5 and subject also
to Section 4.5d, this notice shall constitute a designation of such compound as
a COR Option Product. Such notice, to be effective, must be provided to Lilly
and the third party prior to or substantially contemporaneously with the [*].
COR may, at its election, undesignate [*] as a COR Option Product and
substitute one compound for each undesignated compound, provided that COR may
not undesignate a compound after the [*] of such compound. Upon a decision by
COR and/or a licensee of COR to proceed with [*] of such COR Option Product [*],
the notice provided by COR to Lilly pursuant to this Section 4.5a shall be
updated to include [*]. COR may make up to [*] compounds substitutions under
this Section 4.5a. Once a compound has been undesignated by COR, such compound
may not be subsequently designated by COR. A designation by COR of a compound
as a COR Option Product shall not itself constitute the exercise of an option
to take a license for such compound under Section 16.1(d). Such option exercise
shall occur by means of an express notice of exercise by COR, which notice must
be provided to Lilly and the third party prior to [*] of a COR Option Product
shall be deemed an option exercise by COR even if no express election
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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was made, in which case COR shall provide [*]. COR may exercise its option to
take a license under Section 16.1(d) only as [*]; may not [*] covered by such
exercised option; and may not exercise such option after [*].
14. Section 4.5b shall be inserted following Section 4.5a as follows:
4.5b DEVELOPMENT OF SPECIFIC NEW CHEMISTRY COMPOUNDS. Between
April 30, 1996 and [*], substantially contemporaneously with [*] by COR, COR
shall notify, in writing, Lilly and a mutually agreed third party of such
administration. The notice to Lilly shall include identification of the
compound [*], and the notice to the third party shall include identification
of the compound [*] and shall constitute perfection of COR's rights to
exclusivity for that compound under Section 16.1(e), subject to prior
designation of such compound for development under Section 4.5 and subject
also to Section 4.5d and subject to royalty obligations as set forth in
Section 13.6. Upon a decision by COR and/or a licensee of COR to proceed with
[*], the notice provided by COR to Lilly pursuant to this Section 4.5b shall
be updated to include identification of the compound [*].
15. Section 4.5c shall be inserted following Section 4.5b as follows:
4.5c DEVELOPMENT OF SPECIFIC PAI AGENTS. Commencing [*],
substantially contemporaneously with administration of the [*] by either party,
such party shall notify, in writing, the other Party and a mutually agreed
third party of such administration. The notice to the other Party shall include
identification of the compound [*], and the notice to the third party shall
include identification of the compound [*] and, subject to prior designation
of the compound for development under Section 4.5 and subject also to Section
4.5d, shall constitute perfection of the notifying party's rights to
exclusivity for that compound under Section 16.1(g) or 16.2(d), as applicable,
subject to royalty obligations as set forth in Sections 13.6, 13.19 and 13.20,
and thereafter, such compound shall be excluded from the definitions of
Collaboration Compound and Product. Upon a decision by either party to proceed
with a [*], the notice
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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provided by either Party to the other Party pursuant to this Section 4.5c shall
be updated to include identification of the compound [*].
16. Section 4.5d shall be inserted following Section 4.5c as follows:
4.5d RESPONSIBILITIES OF AGREED THIRD PARTY. The Parties shall
agree on a third party to receive the notices and hold the information to be
disclosed to a mutually agreed third party pursuant to Sections 4.5a, 4.5b and
4.5c. Upon receipt of a notice by a Party of [*] of a compound or other claim
to exclusivity for a particular compound under Sections 4.5, 4.5a, 4.5b or
4.5c, the third party shall determine if it has already received a notice that
such compound is being actively developed by the other Party. The third party
shall, within ten business days, communicate to both Parties whether that
compound, by name, is or is not available for the notifying Party's development
at that time. No perfection of a Party's rights to exclusivity for a compound
under Sections 16.l(d), 16.l(e), 16.l(g) or 16.2(d), shall occur without such
clearance for development by the third party. COR shall bear the expenses
incurred in connection with the third party's services under this Agreement.
17. Section 5.11 shall be inserted following Section 5.10 as follows:
5.11 TERMINATION OF CERTAIN DEVELOPMENT PROGRAMS. Lilly hereby
confirms that it has terminated its rights to develop [*] and [*] pursuant to
Section 5.9 of the Agreement.
18. Section 7.8 shall be deleted in its entirety and shall be replaced
with the following:
7.8 COMMERCIALIZATION OF NON CO-DEVELOPED PRODUCTS BY LILLY. Lilly
agrees to exercise reasonable and diligent efforts toward developing and
commercializing products developed by it under this Agreement that are not Co-
Developed Products. Other than the responsibilities of COR determined by the
Joint Research Committee in accordance with Section 4.3, such development and
commercialization shall occur at the expense of Lilly. Such development and
commercialization shall be conducted in accordance with Lilly's internal
standards with respect to matters such as development timetables, expenditures,
pricing, promotion and advertising, taking into account relevant parameters
including market size, profit margins and competition. In connection with the
development of each Lilly Product, or Product that is not a Co-Developed
Product, Lilly shall provide to COR an annual report listing the general
efforts devoted
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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to that product for the year including the following information: a list of the
[*] completed during the year covered by the report, a list of the [*]
commenced or ongoing during the year covered by the report and a list of the
compounds taken out of development during the year covered by the report. The
obligation to provide such reports shall begin upon the First Human Dose for
such product and shall continue until (i) the first sale of such product, or
(ii) development is terminated. If such a product is introduced commercially,
Lilly shall thereafter advise COR promptly of each application filed by its for
regulatory approval of such product in a new country, and each related
regulatory approval that is obtained. In the event COR begins to participate in
development of a Product but terminates such participation in particular
countries or overall pursuant to Section 5.8, Lilly shall thereafter provide
the reports called for in this Section 7.8.
19. Section 7.9 shall be inserted following 7.8 as follows:
7.9 COMMERCIALIZATION OF NON CO-DEVELOPED PRODUCTS BY COR. COR
agrees to exercise reasonable and diligent efforts toward developing and
commercializing products developed by it under this Agreement that are not
Co-Developed Products, including Terminated Co-Development Products, COR Option
Products, Specific New Chemistry Compounds, and COR Products. Other than the
responsibilities of Lilly determined by the Joint Research Committee in
accordance with Section 4.3, such development and commercialization shall occur
at the expense of COR. Such development and commercialization shall be
conducted in accordance with COR's internal standards with respect to matters
such as development timetables, expenditures, pricing, promotion and
advertising, taking into account relevant parameters including market size,
profit margins and competition. In connection with the development of each
Terminated Co-Development Product, COR Option Product, Specific New Chemistry
Compound, COR Product, or Product that is not a Co-Developed Product, COR shall
provide to Lilly an annual report listing the general efforts devoted to that
product for the year including the following information: a list of the [*]
completed during the year covered by the report, a list of the [*] commenced or
ongoing during the year covered by the report and a list of the compounds taken
out of development during the year covered by the report. The obligation to
provide such reports shall begin upon the First Human Dose for such product and
shall continue until (i) the first sale of such product, or (ii) development of
such product is terminated. If such a product is introduced commercially, COR
shall thereafter advise Lilly promptly of each application filed by it for
regulatory approval of such product in a new country, and each related
regulatory approval that is obtained. In the event Lilly begins to participate
in development of a Product but terminated such participating in particular
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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countries or overall pursuant to Section 5.8, COR shall thereafter provide the
reports called for in this Section 7.9.
20. Section 9.9 shall be inserted following Section 9.8 as follows:
9.9 cGMP COMPLIANCE AND QA AUDITS. After the Amendment Effective
Date, Lilly shall not be responsible for the manufacture of COR Option
Products, COR Products, Specific New Chemistry Compounds or Terminated
Co-Development Products. Notwithstanding the previous sentence, after the
Amendment Effective Date, Lilly shall be responsible for the manufacture of
Products developed pursuant to Section 4.5 and for the completion of
manufacturing of the bulk [*] lots that were commenced during the Research
Term. During the first [*] the Amendment Effective Date, upon written request
to Lilly and at a mutually agreeable time during normal business hours, COR
shall have the right, with respect only to such manufacture of [*] to (i) have
representatives visit Lilly's or its subcontractors' manufacturing facilities,
as applicable, (ii) review Lilly's or its subcontractors' manufacturing,
operations and assess their compliance with cGMP and quality assurance
standards, and (iii) discuss any related issues with Lilly's or its
subcontractors' manufacturing and management personnel. During the first [*] the
Amendment Effective Date, Lilly shall cooperate and cause its subcontractor to
cooperate with any inspection by the FDA or other regulatory agency, including
but not limited to any inspection prior to approval of the NDA for a Terminated
Co-Development Product containing [*].
While it is not anticipated that the FDA or other regulatory agencies
will seek to inspect or review the manufacturing of [*] by Lilly or its
subcontractors after the expiration of [*] from the Amendment Effective Date,
all parties to this agreement acknowledge the right of these agencies to do so.
In view of such potential regulatory inspection or review, Lilly agrees not to
destroy any records directly relating to the manufacturing of [*] by Lilly or
its subcontractors without first notifying COR and giving COR a reasonable
opportunity to obtain such records. In the event that such a review or
inspection is requested, COR, Lilly and Lilly's subcontractors will (i) confer
with each other with respect to the best means to comply with any such agency
requests, and (ii) use their respective best efforts to comply with such
requests. COR shall bear the reasonable direct costs incurred by Lilly in
complying with this Section 9.9.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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21. Section 13.7 shall be deleted in its entirety and shall be replaced with
the following:
13.7 ADDITIONAL PAYMENT BY LILLY. COR acknowledges and agrees that as
of the Amendment Effective Date, Lilly has made all payments owed to COR under
this Section.
22. Section 13.8 shall be deleted in its entirety and shall be replaced with
the following:
13.8 ADDITIONAL PAYMENT BY COR. COR Shall pay to Lilly a single lump
sum of [*] to be paid upon [*] Product, COR Product, COR Option Product or
Terminated Co-Development Product containing as its active ingredient a PAI
Agent originally discovered by Lilly (the "Additional Payment Due Date"). COR
may, at its election, defer such payment up to [*] months after the Additional
Payment Due Date, provided, however, that interest will accrue on the amount
due at the rate of [*] per annum. Only a single payment of [*] plus interest,
if any, shall be required under this Section 13.8.
23. Section 13.19 shall be inserted following Section 13.18 as follows:
13.19 ROYALTY ON PRODUCTS DEVELOPED BY COR. COR shall pay to Lilly a
running royalty at a rate of (i) [*] of Royal-Bearing Sales of [*], and (ii)
[*] of Royalty-Bearing Sales of [*], COR Option Products, Specific New Chemistry
Compounds and COR Products for which exclusivity is perfected under Section
4.5d and Sections 4.5a, 4.5b or 4.5c. Such royalties shall be exclusive of
inventor law payments and shall be paid quarterly, on a country by country
basis, within sixty (60) days of the end of the relevant quarter, from the date
of the first commercial sale of such product in a particular country until the
later of ten (10) years from the first commercial sale in such country or the
last to expire of any Lilly Patent Rights granted before the end of that ten
(10)-year period in that country for which a Valid Claim thereof covers the
manufacture, use or sale of the product, subject to the following reduction:
The royalty rate in a given country shall be reduced by fifty percent
(50%) if (i) the patent coverage in such country expires before the end of the
ten (10) year period specified above, or (ii) a Generically Equivalent Product
is introduced following expiration of patent coverage in such country.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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Such royalties shall be subject to the provisions of Sections 13.9
through 13.13, 13.15, 13.17 and 13.18. For the purposes of this Section and
Sections 13.9 through 13.13, 13.15, 13.17 and 13.18, Royalty-Bearing Sales
shall include sales by COR of COR Option Products, COR Products, Specific New
Chemistry Compounds and Terminated Co-Development Products.
24. Section 13.20 shall be inserted following Section 13.19 as follows:
13.20 ROYALTY ON LILLY PRODUCTS. Lilly shall pay to COR a running
royalty at a rate of [*] of Royalty-Bearing Sales of Lilly Products for which
exclusivity is perfected under Sections 4.5c and 4.5d. Such royalties shall be
exclusive of inventor law payments and shall be paid quarterly, on a country by
country basis, within sixty (60) days of the end of the relevant quarter, from
the date of the first commercial sale of each compound in a particular country
until the later of ten (10) years from the first commercial sale in such
country or the last to expire of any COR Patent Rights granted before the end
of that ten (10)-year period in that country for which a Valid Claim thereof
covers the manufacture, use or sale of the product, subject to the following
reduction:
The royalty rate in a given country shall be reduced by fifty percent
(50%) if (i) the patent coverage on such compound in such country expires
before the end of the ten (10) year period specified above, or (ii) a
Generically Equivalent Product is introduced following expiration of patent
coverage for that compound in such country.
Such royalties shall be subject to the provisions of Sections 13.9
through 13.13, 13.15, 13.17 and 13.1.18.
25. Section 14.5 shall be inserted following Section 14.4 as follows:
14.5 TERMINATED CO-DEVELOPMENT PRODUCTS. The Parties agree that COR
shall have the exclusive right to research, develop, commercialize, market and
sell [*], [*], or both, independently or with any third party. Without limiting
the foregoing, COR shall have no obligation to disclose to Lilly any data or
information relating to [*] or [*] except as expressly provided under this
Agreement. The separate activities of COR with respect to Terminated
Co-Development Products, taken alone, shall not be deemed a violation of any
best efforts or other diligence obligation herein.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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26. Section 14.6 shall be inserted following Section 14.5 as follows:
14.6 COR OPTION PRODUCTS. The Parties agree that COR shall have an
option to obtain the exclusive right to develop, commercialize, market and sell
COR Option Products, independently or with any third party, pursuant to Section
16.1. Without limiting the foregoing, COR shall have no obligation to disclose
to Lilly any data or information relating to COR Option Products except as
expressly provided under this Agreement. The separate activities of COR with
respect to COR Option Products, taken alone, shall not be deemed a violation of
any best efforts or other diligence obligation herein.
27. Section 14.7 shall be inserted following Section 14.6 as follows:
14.7 COR PRODUCTS AND SPECIFIC NEW CHEMISTRY COMPOUNDS. The Parties
agree that COR shall have the exclusive right to develop, commercialize, market
and sell COR Products and Specific New Chemistry Compounds, independently or
with any third party, pursuant to Section 16.1. Without limiting the foregoing,
COR shall have no obligation to disclose to Lilly any data or information
relating to COR Products or Specific New Chemistry Compounds except as
expressly provided under this Agreement. The separate activities of COR with
respect to COR Products or Specific New Chemistry Compounds, taken alone, shall
not be deemed a violation of any best efforts or other diligence obligation
herein.
28. Section 14.8 shall be inserted following Section 14.7 as follows:
14.8 LILLY PRODUCTS. The Parties agree that Lilly shall have the
exclusive right to develop, commercialize, market and sell Lilly Products,
independently or with any third party, pursuant to Section 16.2. Without
limiting the foregoing, Lilly shall have no obligation to disclose to COR any
data or information relating to Lilly Products except as expressly provided
under this Agreement. The separate activities of Lilly with respect to Lilly
Products, taken alone, shall not be deemed a violation of any best efforts or
other diligence obligation herein.
29. Section 15.1 shall be deleted in its entirety and shall be replaced with
the following:
15.1 PATENTABLE INVENTIONS. The Parties intend to establish broad
patent protection for PAI Agents arising from the Research. If a patentable
invention is conceived in the course of and within the scope of the Research
and reduced to
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practice during the Research Term. Lilly and COR shall discuss that invention
and the desirability of filing a United States patent application covering the
invention, as well as any foreign counterparts. Each Party shall provide the
other Party with copies of all preliminary invention disclosure documents which
disclose a PAI Agent conceived in the course of and within the scope of the
Research and reduced to practice during the Research Term.
Lilly shall own all inventions within the scope of the Research made
solely by its employees ("Lilly inventions"), and COR shall own all inventions
within the scope of the Research made solely by its employees ("COR
inventions"). All patent applications and patents on inventions made jointly by
employees of Lilly and employees of COR shall be owned jointly by COR and Lilly
("COR-Lilly inventions").
All patent filings on all inventions within the scope of the Research
made solely by employees of Lilly, and on inventions made jointly by employees
of Lilly and employees of COR, shall be prepared, filed, prosecuted and
maintained worldwide by a third-party patent counsel acceptable to COR and
Lilly. COR shall have the ultimate responsibility for such filings, and COR
shall bear all expenses incurred in filing and prosecuting Lilly and COR-Lilly
patents under this Section. COR or its designee shall provide to Lilly copies
of invoices on third-party patent expenses incurred under this Section.
COR or its designee shall provide to Lilly drafts of any patent
application which discloses a PAI Agent conceived in the course of and within
the scope of the Research and reduced to practice during the Research Term,
prior to filing that application in the United States, allowing adequate time
for review and comment by Lilly if possible. COR shall not be obligated to
delay the filing of any patent application, however it shall use its best
efforts to incorporate into the draft the comments and suggestions of Lilly
such that, to the greatest extent possible, all patent applications on Lilly
and COR-Lilly inventions represent a consensus position by Lilly and COR. Lilly
shall maintain any such patent application in confidence, pursuant to Section
17.1.
COR or its designee shall keep Lilly fully informed of patent
prosecution efforts on patentable inventions made jointly or separately,
conceived in the course of and within the scope of the Research and reduced to
practice during the Research Term. COR or its designee shall provide Lilly with
timely notice and copies of failed patent applications, official actions and
proposed responses pending in the United States and foreign prosecution of
these patentable inventions, allowing adequate time for review and comment by
Lilly, and with respect to Lilly and COR-Lilly inventions, shall use its
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best efforts to incorporate into any proposed response the comments and
suggestions of Lilly regarding these prosecution efforts such that, to the
greatest extent possible, all patent submissions on Lilly and COR-Lilly
inventions represent a consensus position by Lilly and COR. COR or its designee
shall, on a quarterly or more frequent basis, report to Lilly on the status of
the patent applications and patents for which it has primary responsibility
under this Section.
On Lilly and COR-Lilly inventions under this Section, COR shall not,
without the prior written consent of Lilly, authorize the third-party patent
counsel to make any amendments to a draft or filed patent application or patent
for which it has primary responsibility under this Section, if such amendment
would reduce the written description in the application, or narrow the scope of
pending claims, or if its action would have the effect of reducing the
enforceable duration of the patent term of any aspect of the invention. COR
shall have complete discretion with regard to the filing and prosecution of its
solely owned inventions under this Section.
If a party decides not to prosecute, file or maintain an application or
patent on its invention, or on a joint invention, in any country, it shall give
the other Party reasonable notice to this effect; after that notice, the other
Party may, at its expense, prosecute, file or maintain the application or
patent.
30. Section 15.9 shall be inserted following Section 15.8 as follows:
15.9 LITIGATION.
(a) DEFENSE. If the use of the Lilly Patent Rights or Lilly
Know-how results in a claim for patent infringement against COR in connection
with the sale by COR of [*], a COR Option Product, a COR Product, or a Specific
New Chemistry Compound, the party having notice of the claim shall promptly
notify the other Party in writing. The notice shall set forth the facts of the
claim in reasonable detail. COR shall have the primary right, but not the
obligation, to defend against and settle such claim. Lilly shall cooperate with
COR at COR's request and expense in such defense and shall have the right to be
represented by counsel of its own choice and at Lilly's expense. If COR shall
fail to defend against such claim within a period of one hundred twenty (120)
days after receiving written notice of such claim, Lilly shall have the right
to defend by counsel of Lilly's own choice and COR shall have the right, at its
own expense, to be represented by counsel of its own choice.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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(b) ROYALTY REDUCTION. If, as a result of settlement procedures or
litigation COR is required to pay the third party a royalty or make any payment
of any kind for the right to use the Lilly Patent Right or Lilly Know-how in a
particular country, exclusive of inventor law payments, COR may deduct, from
the amount of royalties owed to Lilly in connection with the same country,
fifty percent (50%) of the amount of the royalty or such other amount payable
to Lilly up to, but no more than, fifty percent (50%) of the amounts otherwise
payable to Lilly in connection with sales in that particular country.
31. Section 15.10 shall be inserted following Section 15.9 as follows:
15.10 ENFORCEMENT OF LILLY PATENT RIGHTS. If any patent in the Lilly
Patent Rights relating to [*], a COR Option Product, a COR Product, or a
Specific New Chemistry Compound, is infringed by a third party, the party to
this Agreement first having knowledge of such infringement shall promptly
notify the other in writing. The notice shall set forth the facts of that
infringement in reasonable detail.
(a) COR shall have the primary right, but not the obligation, to
institute, prosecute, and control any action or proceeding with respect to
third party infringement of the Lilly Patent Rights relating to [*], a COR
Option Product, a COR Product, or a Specific New Chemistry Compound, by counsel
of its own choice. Lilly agrees to be joined as a party plaintiff and to give
COR, at COR's request, reasonable-assistance and authority to file and
prosecute the suit. Lilly shall have the right, at its own expense, to be
represented in that action by counsel of its own choice. If COR fails to bring
an action or proceeding within a period of [*] or otherwise having knowledge of
that infringement, or if the infringement relates solely to Lilly Patent Rights
which do not relate to [*], a COR Option Product, a COR Product, or a Specific
New Chemistry Compound, Lilly shall have the right to bring and control any
such action by counsel of its own choice, and COR shall have the right to be
represented in any such action by counsel of its own choice at its own expense.
(b) COR shall retain any damages or other monetary awards recovered
in favor of COR and/or Lilly in connection with third party infringement of the
claims relating to [*] COR Option Products, Specific New Chemistry Compounds or
COR Products if COR brings and prosecutes the action through to a final
judgment. To the extent any damages or other monetary awards are recovered in
favor of COR and/or Lilly in connection with third party infringement of the
Lilly Patent Rights, and COR has
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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brought and prosecuted the action, COR shall be reimbursed for its costs and
expenses of the litigation and any remaining amounts shall belong to Lilly.
(c) No settlement or consent judgment or other voluntary final
disposition of a suit under this Section 15.10 may be entered into without the
joint consent of COR and Lilly, which consent shall not be unreasonably
withheld.
32. Section 16.1 shall be deleted in its entirety and shall be replaced with
the following:
16.1 LICENSES TO COR. In consideration of the payments and commitments
made by COR to Xxxxx, Xxxxx grants to COR, subject to the terms and conditions
of this Agreement:
(a) An exclusive (except as to Lilly), fully-paid worldwide
license under Lilly Patent Rights for COR to discover and develop Products, to
manufacture and have manufactured Products as provided in Section 9.8, and to
import, use, offer for sale and sell Co-Promoted Products within the Field
within the Co-Promotion Territory;
(b) An exclusive (except as to Lilly) license, with right to
sublicense, under Lilly Patent Rights for COR to conduct research on Specific
PAI Agents;
(c) An exclusive (even as to Lilly) worldwide license, with the
right to sublicense, under Lilly Patent Rights, to develop, manufacture, have
manufactured, import, use, offer for sale and sell Terminated Co-Development
Products for all human and animal therapeutic indications, subject to the
royalty obligations set forth in Section 13.19;
(d) An option to an exclusive (even as to Lilly) worldwide
license, with the right to sublicense, under Lilly Patent Rights for [*], COR
Option Products, for COR to develop, manufacture, have manufactured, import,
use, offer to sell and sell COR Option Products for all human and animal
therapeutic indications, exercisable, with respect to each such product, in the
manner set forth in Section 4.5a, prior to the earlier of the [*], subject to
the provisions of Section 4.5b and 4.5d, and the royalty obligations set forth
in Section 13.19;
(e) An exclusive (even as to Lilly) worldwide license, with
the right to sublicense, under Lilly Patent Rights to develop, manufacture,
have manufactured,
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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import, use, offer to sell and sell Specific New Chemistry Compounds for all
human and animal therapeutic indications, subject to the royalty obligations
set forth in Section 13.19;
(f) A nonexclusive, fully-paid, worldwide license, under the
Lilly Know-how and Project Information to discover, develop, manufacture, have
manufactured, import, use, offer for sale and sell Products within the Field
during the Research Term, and for any and all purposes after April 30, 1996,
subject only to Articles 4.4, 4.5 and 17 hereof. Upon the Amendment Effective
Date, COR may grant sublicenses under this Section 16.1(f) for Terminated Co-
Development Products, COR Option Products, Specific New Chemistry Compounds and
COR Products. Commencing [*], COR may grant sublicenses under this Section
16.1(f) for any and all purposes; and
(g) Commencing [*], a co-exclusive worldwide license with the
right to sublicense under Lilly Patent Rights to develop, manufacture, have
manufactured, import, use, offer for sale and sell COR Products for all human
and animal therapeutic indications subject to the royalty obligations set forth
in Section 13.19. Commencing upon [*] of a compound within the scope of Lilly
Patent Rights and subject to the provisions of Section 4.5b, under the
direction of COR or a COR licensee, said co-exclusive license shall be
exclusive (even as to Lilly) subject to the royalty obligations set forth in
Section 13.19.
The license granted in Section 16.1(a) shall not be sublicensable by COR
without the consent of Lilly except to Affiliates owned 80% or more by COR.
Lilly grants no licenses herein under the Lilly Patent Rights except with
respect to Products, Terminated Co-Development Products, COR Option Products,
and Collaboration Compounds, and for the purpose of implementing the provisions
of this Agreement.
Appendix 2 hereto sets forth a list of patents and patent applications,
together with a list of invention disclosure statements received by Lilly's
patent department, from which the Lilly Patent Rights referenced in this
Section 16.1 flow.
If COR's rights with respect to a Product terminate as provided in
Section 6.3, COR's license, under Lilly Patent Rights, with respect to such
Product in such country shall terminate and Lilly shall have an exclusive
license, with right to sublicense, under COR Patent Rights, to discover,
develop, manufacture, have manufactured, use and sell such Product within the
Field within such country.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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COR shall not be obligated to re-offer Terminated Co-Development
Products, COR Option Products, COR Products or Specific New Chemistry Compounds
to the collaboration as contemplated by Section 5.10.
33. Section 16.2 shall be inserted following Section 16.1 as follows:
16.2 LICENSES TO LILLY. In consideration of the payments and
commitments made by Lilly to COR, COR grants to Lilly, subject to the terms and
conditions of this Agreement:
(a) An exclusive (except as to COR), fully-paid worldwide
license, with right to sublicense, under COR Patent Rights, for Lilly to
discover, develop, manufacture, have manufactured, import, use, offer for sale
and sell Products within the Field;
(b) An exclusive (except as to COR) license, under COR Patent
Rights for Lilly to conduct research on Specific PAI Agents;
(c) A nonexclusive, fully-paid, worldwide license, under COR
Know-how and Project Information to discover, develop, manufacture, have
manufactured, import, use, offer for sale and sell Products within the Field
during the Research Term, and for any and all purposes thereafter, subject only
to Articles 4.4, 4.5 and 17 hereof. Commencing [*], Lilly may grant sublicenses
under this Section 16.2(c); and
(d) Commencing [*] a co-exclusive worldwide license with the
right to sublicense under Co Patent Rights to discover, develop, manufacture,
have manufactured, import, use, offer for sale and sell Lilly Products for all
human and animal therapeutic indications, subject to the royalty obligations
set forth in Section 13.22. Commencing upon [*] of a compound within the scope
of COR Patent Rights and subject to the provisions of Sections 4.5c and 4.5d,
under the direction of Lilly or a Lilly licensee, said co-exclusive license
shall be exclusive (even as to COR) subject to the royalty obligations set
forth in Section 13.20.
COR grants no licenses herein under COR Patent Rights except with
respect to Products, Lilly Products and Collaboration Compounds, and for the
purpose of implementing the provisions of this Agreement.
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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Appendix 3 hereto sets forth a list of patents and patent applications,
together with a list of invention disclosure statements received by COR's
patent department, from which the COR Patent Rights referenced in this Section
16.2 flow.
If Lilly's rights with respect to a Product terminate as provided in
Section 6.3, Lilly's license, under COR Patent Rights, with respect to such
Product in such country shall terminate and COR shall have an exclusive
license, with right to sublicense, under Lilly Patent Rights, to discover,
develop, manufacture, have manufactured, use and sell such Product within the
Field within such country. If Lilly's rights to a Product terminate as provided
in Section 5.9, such license shall be worldwide.
Lilly shall not be obligated to re-offer Lilly Products to the
collaboration as contemplated by Section 5.10.
34. Section 16.3 shall be inserted following Section 16.2 as follows:
16.3 DISCLOSURE OF INFORMATION BY LILLY. Promptly after execution of
this Amendment, but no later than 45 days after the full execution of this
Amendment, Lilly shall disclose to COR all Project Information and confidential
and/or proprietary chemical substances, biological materials, technical
information, clinical and other information (including commercial information),
data and assays which Lilly owns or controls relating to Terminated Co-
Development Products, non-specific PAI Agents and Specific PAI Agents, including
but not limited to all data generated in connection with the manufacturing and
other processes and final reports for all studies performed in connection with
these compounds. As to any such study related to the research or development of
Terminated Co-Development Products, non-specific PAI Agents and Specific PAI
Agents for which no final report has been prepared, whether or not such study
was completed, Lilly will prepare such final report for delivery to COR no
later than 45 days after the full execution of this Amendment, and COR shall
bear the reasonable direct costs incurred by Lilly in preparing such report.
Lilly shall cause its employees and consultants to participate with COR's
employees and consultants in any discussion of the information and reports
disclosed by Lilly to COR hereunder until the expiration of 90 days after the
full execution of this Amendment. Any reports due to Lilly hereunder shall be
delivered both in hard copy and electronically readable form.
35. Section 16.4 shall be inserted following Section 16.3 as follows:
16.4 DISCLOSURE OF INFORMATION BY COR. Promptly after execution of
this Amendment but no later than 45 days after the fall execution of this
Amendment, COR
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shall disclose to Lilly all Project Information and confidential and/or
proprietary chemical substances, biological materials, technical information,
clinical and other information (including commercial information), data and
assays which COR owns or controls relating to non-specific PAI Agents and
Specific PAI Agents, including but not limited to all data generated in
connection with the manufacturing and other processes developed in connection
therewith, and reports and final reports for all studies performed in
connection with any of these compounds. As to any such study related to the
research or development of non-specific PAI Agents and Specific PAI Agents for
which no report or final report has been prepared, whether or not such study
was completed, COR will prepare such final report for delivery to Lilly no
later than 45 days after the full execution of this Amendment, and Lilly shall
bear the reasonable direct costs incurred by COR in preparing such report. COR
shall cause its employees and consultants to participate with Lilly's employees
and consultants in any discussion of the information and reports disclosed by
COR to Lilly hereunder until the expiration of 90 days after the full execution
of this Amendment. Any reports due to Lilly hereunder shall be delivered both
in hard copy and electronically readable form.
36. Section 16.5 shall be inserted following Section 16.4 as follows:
16.5 TRANSFER OF IND. Promptly following execution of this Amendment,
Lilly shall take all necessary action to transfer to COR the sponsorship and
ownership of all Investigational New Drug Applications and foreign equivalents
filed in connection with Terminated Co-Development Products.
37. Section 16.6 shall be inserted following Section 16.5 as follows:
16.6 TRANSFER OF USAN APPLICATION. Promptly following execution of
this Amendment, Lilly shall take all necessary action to transfer to COR the
sponsorship and ownership of all United States Adopted Name applications and
foreign equivalents filed in connection with Terminated Co-Development
Products.
38. Section 16.7 shall be inserted following Section 16.6 as follows:
16.7 NO ASSURANCES UNDER THIRD PARTY INTELLECTUAL PROPERTY RIGHTS. The
Parties disclaim any express or implied warranty of freedom from infringement
of third party intellectual property rights.
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39. Section 17.1 shall be deleted in its entirety and shall be replaced with
the following:
17.1 CONFIDENTIALITY. Except as otherwise provided in writing by the
Parties, both Parties shall use their best efforts to retain in confidence and
shall not use, except as provided in this Agreement, all information relating
to the Research. Such information may, however, be disclosed insofar as such
disclosure is necessary (where possible, with advance notice to the other party
and with adequate safeguards for confidentiality) to allow either party to
defend against litigation with a third party, to file and prosecute patent
applications, or to comply with governmental regulations or tax requirements,
or to advise a partner or potential partner of the rights and obligations of
the parties under this Agreement, provided neither Party shall use the other
Party's information in any patent application without prior written approval
from the other Party. Notwithstanding the foregoing, COR may, in its sole
discretion, publish and present the results of studies carried out with respect
to Terminated Co-Development Products, COR Option Products, COR Products and
Specific New Chemistry Compounds, and Lilly may publish and present the results
of studies carried out with the compound [*] with COR's prior written consent,
COR's consent not to be unreasonably withheld.
COR may disclose, under appropriate binders of confidentiality and in
its sole discretion, the terms of this Agreement, Lilly Patent applications,
Project Information and any other information disclosable under Section 16.3
relevant to Specific PAI Agents.
After [*], Lilly may disclose, under appropriate binders of
confidentiality and in its sole discretion, the terms of this Agreement, COR
Patent applications, Project Information and information disclosable under
Section 16.4 relevant to Specific PAI Agents.
Commencing [*], each of COR and Lilly may publish and present the results
of studies carried out with those compounds to which such Party has secured
exclusive rights pursuant to Section 4.5c.
The foregoing obligations of confidentiality and non-use shall not apply
to information which (i) is in the public domain, (ii) comes into the public
domain through no fault of the receiving Party, (iii) was known by the
receiving Party prior to disclosure under this Agreement as demonstrated by
written evidence generated at the time of
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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claimed knowledge, or (iv) is disclosed to the receiving Party without an
obligation of confidentiality by a third party having a lawful right to make
the disclosure.
If a Party wishes to make a disclosure other than as provided for in
this Section 17.1 in furtherance of the objectives of the Agreement and
notwithstanding the provisions of Section 11.6, with the written approval of
both Parties, either Party may disclose confidential information concerning
Collaboration Compounds or Products obtained from the other Party under this
Agreement to a third party who has agreed in writing to be bound by the same or
similar obligations of confidence set forth in this Section, provided the third
party agrees not to use the confidential information without authorization from
the Party owning the information.
All obligations of confidentiality and non-use imposed upon the Parties
under this Agreement shall expire on the later of (i) ten (10) years from the
termination of the Research or (ii) expiration of all obligations of payment
under Article 13.
40. Section 17.2 shall be deleted in its entirety and shall be replaced with
the following:
17.2 PUBLICITY REVIEW. COR and Lilly will jointly discuss and agree,
based on the principles of this Section 17.2, on any statement to the public
regarding this Agreement or Collaboration Compounds or Products subject in each
case to disclosure otherwise required by law or regulation. Notwithstanding
Section 11.6, each Party shall have the right to make any statement to the
public as specified in Section 17.1. Except as provided in Section 17.1 with
respect to public statements, if either Party is required by law or regulation
to make a public disclosure or announcement concerning such topics, such Party
shall give reasonable prior advance notice of the proposed text of such
disclosure or announcement to the other Party for their review and comment. In
the discussion and agreement referred to above, the principles observed by COR
and Lilly will be: accuracy, the requirements for confidentiality under Section
17.1, and advantage a competitor of COR or Lilly may gain from any public or
Third Party statements under this Section 17.2, the requirements of disclosure
under any applicable securities laws, including those associated with public
offerings, and the standards and customs in the biotechnology and
pharmaceutical industries for such disclosures by companies comparable to COR
and Lilly.
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41. Section 19.1 shall be deleted in its entirety and shall be replaced with
the following:
19.1 INDEMNIFICATION BY LILLY. As to Lilly Products and Products
developed or promoted by Lilly, alone or with a third party, in countries where
such products are not Co-Promoted by the Parties pursuant to this Agreement:
(a) Lilly hereby agrees to save, defend and hold COR and its
agents and employees harmless from and against any and all suits, claims,
actions, demands, liabilities, expenses and/or loss, including reasonable legal
expense and attorneys' fees ("Losses") resulting directly or indirectly from
the manufacture, use, handling, storage, sale or other disposition of chemical
agents, Lilly Products or Products by Lilly, its Affiliates, agents or
sublicensees except to the extent such Losses result from the negligence or
wrongdoing of COR.
(b) In the event that COR is seeking indemnification under
Section 19.1(a), it shall inform Lilly of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit Lilly to assume
direction and control of the defense of the claim (including the right to
settle the claim solely for monetary consideration), and shall cooperate as
requested (at the expense of Lilly) in the defense of the claim.
42. Section 19.3 shall be deleted in its entirety and shall be replaced with
the following:
19.3 INDEMNIFICATION BY COR. As to Terminated Co-Development Products,
COR Option Products, COR Products, Specific New Chemistry Compounds and
Products developed or promoted by COR, alone or with a third party, in
countries where such products are not Co-Promoted by the Parties pursuant to
this Agreement:
(a) COR hereby agrees to save, defend and hold Lilly and its
agents and employees harmless from and against any and all suits, claims,
actions, demands, liabilities, expenses and/or loss, including reasonable legal
expense and attorneys' fees ("Losses") resulting directly or indirectly from
the manufacture, use, handling, storage, importation, offer for sale, sale or
other disposition of chemical agents, COR Option Products, Terminated Co-
Development Products, COR Products, Specific New Chemistry Compounds designated
for development under Section 4.5b, or Products by COR, its Affiliates, agents
or sublicensees except to the extent such Losses result from the negligence or
wrongdoing of Lilly.
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(b) In the event that Lilly is seeking indemnification under
Section 19.3(a), it shall inform COR of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit COR to assume
direction and control of the defense of the claim including the right to settle
the claim solely for monetary consideration), and shall cooperate as requested
(at the expense of COR) in the defense of the claim).
43. Except as otherwise amended herein, the Agreement shall remain in full
force and effect.
This Amendment shall be effective as of the date first written above.
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IN WITNESS WHEREOF, the parties hereto have duly executed this
Amendment.
COR THERAPEUTICS, INC. XXX XXXXX AND COMPANY
By: /s/ By: /s/
------------------------------- -------------------------------
Xxxxxxx X. Homey, M.D. August X. Xxxxxxxx, M.D.
Executive Vice President- Executive Vice President,
Title: Research & Development Title: Science and Technology
---------------------------- ----------------------------
APPENDIX 1 - [*]
APPENDIX 2 - [*]
APPENDIX 3 - [*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
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APPENDIX 1 - [*]
[*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
31
APPENDIX 2 - [*]
[*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
32
APPENDIX 3 - [*]
[*]
* Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 24-b2 of the Securities Exchange Act
of 1934, as amended.
