Exhibit 10.4
EXECUTION COPY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)4, AND
240.24b-2
NOVATED AND
RESTATED
TECHNOLOGY LICENSE
AGREEMENT
dated as of April 7,
2006
among
ISIS PHARMACEUTICALS,
INC.,
SYMPHONY GENISIS,
INC.
and
SYMPHONY GENISIS HOLDINGS
LLC
Table of Contents
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Page
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Article 1
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Definitions
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1
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Article 2
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Grant Of Rights
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1
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2.1.
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Assignment
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1
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2.2.
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License Grant
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2
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2.3.
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Sublicense to
Licensor
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2
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2.4.
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Right to
Sublicense
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2
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2.5.
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Partial Reversion of License upon
Licensor’s Exercise of Discontinuation Option
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3
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2.6.
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Reservation of
Rights
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3
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2.7.
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Regulatory Files After Expiration
or Termination of Term or Discontinuation Option
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3
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2.8.
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Delivery of Materials After
Expiration or Termination of Term
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4
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2.9.
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License
Opportunities
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5
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2.10.
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Separate Third Party License for
Discontinued Program
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6
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2.11.
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Supply of Materials After
Expiration or Termination of Term
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6
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Article 3
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Sublicense To Certain Third Party Intellectual
Property
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6
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3.1.
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Third Party Sublicense
Payments
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6
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3.2.
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Sublicensed Intellectual
Property
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7
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Article 4
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Intellectual Property
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7
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4.1.
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Ownership
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7
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4.2.
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Marking
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7
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4.3.
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Prosecution and
Maintenance
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7
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4.4.
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Abandonment
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8
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4.5.
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Infringement
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8
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4.6.
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Enforcement Right During
Term
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9
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4.7.
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Post-Term
Enforcement
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10
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4.8.
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Withdrawal of
Enforcement
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11
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4.9.
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Recoveries
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12
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Article 5
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Representations And Warranties
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12
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5.1.
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Representations and Warranties of
Licensor
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12
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5.2.
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Disclaimer and
Acknowledgement
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13
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Article 6
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Indemnification And Limitation Of
Liability
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13
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6.1.
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Indemnity
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13
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6.2.
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Notice of Claims
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14
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6.3.
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Defense of
Proceedings
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14
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6.4.
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Settlement
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15
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6.5.
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Limitation of
Liability
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16
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6.6.
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Insurance
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16
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i
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Article 7
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Term And Termination
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16
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7.1.
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Term
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16
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7.2.
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Termination
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16
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7.3.
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Survival
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17
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7.4.
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Bankruptcy
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17
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Article 8
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Miscellaneous
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17
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8.1.
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Notices
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17
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8.2.
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Entire Agreement
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18
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8.3.
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Assignment
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19
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8.4.
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Headings
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19
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8.5.
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Independent
Contractor
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19
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8.6.
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Severability
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19
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8.7.
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No Third-Party
Beneficiaries
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19
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8.8.
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Compliance with
Laws
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19
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8.9.
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Amendment
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20
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8.10.
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Governing Law; Consent to
Jurisdiction and Service of Process
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20
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8.11.
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WAIVER OF JURY
TRIAL
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20
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8.12.
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Counterparts
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20
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8.13.
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No Waiver
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20
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ANNEX A
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DEFINITIONS
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ANNEX B
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[RESERVED]
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ANNEX C
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CERTAIN PROGRAM-SPECIFIC
PATENTS
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ANNEX D
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CERTAIN ROYALTY AND MILESTONE
PAYMENTS
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SCHEDULE 2.2
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CERTAIN RESTRICTIONS RELATING TO LICENSED
INTELLECTUAL PROPERTY LICENSED TO LICENSOR BY A THIRD
PARTY
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ii
NOVATED AND RESTATED
TECHNOLOGY LICENSE AGREEMENT
This NOVATED AND RESTATED TECHNOLOGY
LICENSE AGREEMENT (this “ Agreement ”) is
made and effective as of April 7, 2006 by and among, Isis
Pharmaceuticals, Inc., a Delaware corporation (the “
Licensor ”), Symphony GenIsis, Inc., a Delaware
corporation (“ Symphony GenIsis ”) (each
of Licensor and Symphony GenIsis being a “
Party ,” and collectively, the “
Parties ”), and Symphony GenIsis Holdings LLC,
a Delaware limited liability company (“
Holdings ”).
WHEREAS, Licensor and Holdings have
entered into that certain Technology License Agreement, dated April
7, 2006 (the “ Original Agreement
”);
WHEREAS, Holdings desires to assign
its right, title and interest in, and delegate and novate its
obligations under the Original Agreement to Symphony GenIsis, and
Licensor and Symphony GenIsis desire to novate and restate the
terms and conditions of the Original Agreement to effect such
novation;
WHEREAS, Licensor owns or has rights
in certain technology, know-how, patents and other intellectual
property rights related to the design, development, manufacture
and/or use of the Products;
WHEREAS, Licensor desires to grant
to Symphony GenIsis, and Symphony GenIsis desires to acquire, the
exclusive (or nonexclusive, as the case may be) right to use such
technology, know-how, patents and other intellectual property
rights to develop and commercialize Products on the terms and
conditions of this Agreement; and
WHEREAS, Licensor desires to
receive, and Symphony GenIsis desires to grant to Licensor, the
exclusive right to use such technology, know-how, patents and other
intellectual property rights to develop Products on behalf of
Symphony GenIsis on the terms and conditions of this
Agreement.
NOW THEREFORE, in consideration of
the mutual promises and agreements set forth herein, and for other
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties agree as
follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used herein and
not defined shall have the meanings assigned to such terms in
Annex A attached hereto.
ARTICLE 2
GRANT OF RIGHTS
2.1.
Assignment . Holdings hereby assigns to Symphony
GenIsis all of its right, title and interest in and to the Original
Agreement. The Parties agree that from and after the Closing
Date, all of the right, title, interest and obligations of Holdings
under the Original
1
Agreement will be assigned, novated
and transferred to, and assumed by, Symphony GenIsis, as amended
and restated by this Agreement.
2.2.
License Grant.
(a)
Subject to Sections 2.3, 2.4, 2.5 and 2.6 below, the limitations
and restrictions set forth on Schedule 2.2, and the terms and
conditions of this Agreement, Licensor hereby grants to Symphony
GenIsis a fully paid, worldwide, exclusive license under the
Licensed Intellectual Property, solely to develop, make, have made,
use, offer for sale, sell, and import Products in the Exclusive
Field; and
(b)
Subject to Sections 2.3, 2.4, 2.5 and 2.6 below, the limitations
and restrictions set forth on Schedule 2.2, and the terms and
conditions of this Agreement, Licensor hereby grants to Symphony
GenIsis a fully paid, worldwide, nonexclusive license under the
Licensed Intellectual Property, solely to develop, make, have made,
use, offer for sale, sell, and import Products in the Nonexclusive
Field.
2.3.
Sublicense to Licensor . Symphony GenIsis hereby
grants to Licensor a fully paid, worldwide, exclusive (even as to
Symphony GenIsis) sublicense under the Licensed Intellectual
Property, with the right to grant further sublicense(s), to
develop, make, have made, use and import Products, or otherwise as
necessary or useful to carry out Licensor’s obligations or
exercise Licensor’s rights under the Operative
Documents. Notwithstanding the foregoing, Licensor shall only
exercise its sublicense rights in connection with and for the
purpose of carrying out Licensor’s obligations or exercising
Licensor’s rights under the Operative Documents. In the
event of the expiration of a Discontinuation Option without
exercise by Licensor, the sublicense set forth in this Section 2.3
shall expire with respect to the Products relating to the Program
to which such Discontinuation Option pertained. Upon the
unexercised expiration or termination of the Purchase Option
without Licensor’s exercise of the Purchase Option, the
sublicense set forth in this Section 2.3 shall expire with respect
to all Products relating to the Program(s) for which Licensor has
not exercised the Discontinuation Option.
2.4.
Right to Sublicense . Subject to the limitations and
restrictions set forth on Schedule 2.2, the license granted
hereunder includes the right of Symphony GenIsis to grant
sublicenses under the Licensed Intellectual Property, provided,
that,
(a)
subject to Sections 2.3 and 2.4(b), Symphony GenIsis shall not
sublicense any of the rights granted pursuant to Section 2.2 to any
third party (including without limitation any Affiliates) during
the Term;
(b)
notwithstanding (a), in the event of the expiration of a
Discontinuation Option without exercise by Licensor, Symphony
GenIsis may grant sublicense(s) to third parties (including without
limitation Affiliates) of the rights granted pursuant to Section
2.2 with respect to the Products relating to the Program to which
such Discontinuation Option pertained;
(c)
each sublicense granted is (i) pursuant to a written contract, (ii)
consistent with the terms of this Agreement, (iii) does not grant
any rights beyond the scope of the license rights granted herein,
and (iv) is as protective of Licensor’s rights as set forth
in this Agreement; and
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(d)
upon Licensor’s written request, Symphony GenIsis shall
provide to Licensor copies of any sublicense agreements, provided
that (i) Symphony GenIsis may redact any financial or other
proprietary information contained therein which does not affect
Licensor’s rights and (ii) Licensor shall treat its copy of
the sublicense agreements as Confidential Information of Symphony
GenIsis.
2.5.
Partial Reversion of License upon Licensor’s Exercise of
Discontinuation Option . Licensor and Symphony GenIsis
acknowledge that Licensor may exercise its Discontinuation Option
pursuant to Section 11.1 of the Amended and Restated Research and
Development Agreement. Upon the Discontinuation Option
Closing Date, as applicable, (i) the license set forth in Section
2.2 (and the corresponding sublicense under Section 2.3) shall
expire with respect to the Products relating to the Program for
which Licensor exercised its Discontinuation Option, as applicable,
(ii) those patents, know-how and enhancements that were previously
part of the Licensed Intellectual Property and relate exclusively
to such Program (including its Products) but not to the other
Programs, shall be deleted from the relevant intellectual property
definitions, and accordingly, Symphony GenIsis shall no longer be
responsible for any obligations or costs (including royalties or
fees to third parties, prosecution costs, maintenance costs and
enforcement costs) accruing after such Discontinuation Option
Closing Date with respect to such patents, know-how and
enhancements; and (iii) Symphony GenIsis shall (a) at
Licensor’s request and option, promptly return to Licensor or
destroy all Tangible Materials relating solely to such Program; and
(b) upon Licensor’s request, provide Licensor a copy of any
Tangible Materials which relate to such Program (but not solely to
such Program). The Parties shall, as necessary, promptly
amend this Agreement, in connection with the exercise and
consummation of the Discontinuation Option pursuant to Section 11.1
of the Amended and Restated Research and Development Agreement, to
give Licensor all rights it needs to pursue the Program for which
such option was exercised without any obligation to or dependency
on Symphony GenIsis and to limit this Agreement to the other
Programs.
2.6.
Reservation of Rights . All rights not expressly
granted to a Party hereunder shall remain the exclusive property of
the other Party. Symphony GenIsis covenants and agrees not to
use or exploit the Licensed Intellectual Property outside of the
scope of the licenses granted herein. Licensor covenants and
agrees not to use or exploit the Licensed Intellectual Property in
connection with the development, manufacture, use, sale, or
importation of Products in the Exclusive Field after the expiration
of all sublicenses granted pursuant to Section 2.3; provided,
however, that such covenant by Licensor shall not apply to any
Program for which Licensor exercises a Discontinuation Option or to
any Products relating to such Program. For the avoidance of
doubt, Isis shall not be restricted from using or otherwise
exploiting any intellectual property relating to drug discovery
platforms outside the fields of the Products and/or the
Programs.
2.7.
Regulatory Files After Expiration or Termination of Term or
Discontinuation Option.
(a)
As soon as reasonably practical after the expiration or termination
of the Purchase Option without exercise by Licensor and as of a
date to be agreed upon by Licensor and Symphony GenIsis, Licensor
and Symphony GenIsis shall, at Symphony GenIsis’ expense,
take all actions necessary to effect the assignment to Symphony
GenIsis or its designee of the
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sponsorship to the
Regulatory Files with respect to the Programs for which Licensor
has not exercised its Discontinuation Option. After such
Regulatory Files are assigned to Symphony GenIsis, Licensor shall
have no further rights therein or obligations thereunder; provided,
however, that during the one hundred eighty (180) days following
such assignment of Regulatory Files, at Symphony GenIsis’
reasonable request and expense, Licensor shall use commercially
reasonable efforts to provide Symphony GenIsis or its designee with
assistance in respect of such Regulatory Files. Licensor
shall, at the reasonable request of Symphony GenIsis and at
Symphony GenIsis’ expense, perform any acts that Symphony
GenIsis may reasonably deem necessary or desirable to evidence or
confirm Symphony GenIsis’ ownership interest in such
Regulatory Files, including, but not limited to, making further
written assignments in a form determined by Symphony GenIsis.
Without limiting the license rights granted under this ARTICLE 2,
the Parties understand and agree that the assignment of such
Regulatory Files does not include an assignment of any Licensed
Intellectual Property.
(b) As soon as
reasonably practical after the expiration of a Discontinuation
Option without exercise by Licensor and as of a date to be agreed
upon by Licensor and Symphony GenIsis, Licensor and Symphony
GenIsis shall, at Symphony GenIsis’ expense, take all actions
necessary to effect the assignment to Symphony GenIsis or its
designee of the sponsorship to the Regulatory Files with respect to
the Programs for which Licensor has not exercised its
Discontinuation Option. After such Regulatory Files are
assigned to Symphony GenIsis, Licensor shall have no further rights
therein or obligations thereunder; provided, however, that during
the one hundred eighty (180) days following such assignment of
Regulatory Files, at Symphony GenIsis’ reasonable request and
expense, Licensor shall use commercially reasonable efforts to
provide Symphony GenIsis or its designee with assistance in respect
of such Regulatory Files. Licensor shall, at the reasonable
request of Symphony GenIsis and at Symphony GenIsis’ expense,
perform any acts that Symphony GenIsis may reasonably deem
necessary or desirable to evidence or confirm Symphony
GenIsis’ ownership interest in such Regulatory Files,
including, but not limited to, making further written assignments
in a form determined by Symphony GenIsis. Without limiting
the license rights granted under this ARTICLE 2, the Parties
understand and agree that the assignment of such Regulatory Files
does not include an assignment of any Licensed Intellectual
Property.
2.8.
Delivery of Materials After Expiration or Termination of
Term.
(a) Upon the unexercised
expiration or termination of the Purchase Option without exercise
by Licensor, Licensor shall, at Symphony GenIsis’ expense,
promptly deliver to Symphony GenIsis all copies of Tangible
Materials existing as of the date of such unexercised expiration or
termination that relate to the Programs for which Licensor has not
exercised its Discontinuation Option; provided, however that
Licensor may also retain copies of (and the right to use) those
Tangible Materials that are required to be delivered to Symphony
GenIsis hereunder but which also relate to (i) any Program for
which Licensor has exercised its Discontinuation Option or (ii) any
other product of Licensor.
(b) In the event of the
expiration of a Discontinuation Option without exercise by
Licensor, Licensor shall, at Symphony GenIsis’ expense,
promptly deliver to Symphony GenIsis all copies of Tangible
Materials existing as of the date of such expiration that relate to
the Program to which the Discontinuation Option pertained;
provided, however that Licensor may
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also retain copies of (and the right to use)
those Tangible Materials that are required to be delivered to
Symphony GenIsis hereunder but which also relate to any other
Program or any other product of Licensor.
(c) Subsequent to any
such unexercised expiration or termination of the Purchase Option
without exercise by Licensor or expiration of a Discontinuation
Option without exercise by Licensor, (i) Licensor shall promptly
notify Symphony GenIsis (and any subsequent partners or transferees
of Symphony GenIsis’ rights hereunder) regarding any safety
or other related issues that Licensor identifies in its safety
database that may be relevant to a Product being developed by
Symphony GenIsis (or any such partner or transferee) hereunder, and
if requested, provide the data supporting Licensor’s
conclusions regarding such issues, and (ii) Symphony GenIsis shall
use commercially reasonable, good faith efforts, to negotiate with
any of its subsequent partners or transferees of Symphony
GenIsis’ rights hereunder to ensure, Isis’ continued
access to safety data and other related information acquired by
Symphony GenIsis or any subsequent partners or transferees of
Symphony GenIsis’ rights hereunder [***].
2.9.
License Opportunities . In the event that, during the
Term, Licensor reasonably determines that it is necessary to
license from any third party any intellectual property relating to
the composition of matter, use, manufacture, formulation or
exploitation of the Products (“ Third Party IP
”) and Licensor desires to license such Third Party IP during
the Term, then (i) if Licensor desires Symphony GenIsis to pay any
or all of the financial obligations under such license, Licensor
shall obtain Symphony GenIsis’ written consent, which shall
not be unreasonably withheld or delayed before acquiring such
license; and (ii) if Symphony GenIsis provides such consent, then
unless otherwise agreed to by the Parties in writing, Licensor
shall use commercially reasonable efforts to obtain, at the time
such license is granted, the right to sublicense such Third Party
IP to Symphony GenIsis consistent with the terms of this Agreement
as if such Third Party IP were Licensed Intellectual
Property. Unless otherwise agreed to by the Parties in
writing, the financial obligations under any licenses to Third
Party IP obtained by Licensor with Symphony GenIsis’ consent
shall (1) be borne fully by Symphony GenIsis if such Third Party IP
relates solely to the composition of matter, use, manufacture,
formulation or exploitation of the Products and, at the time of
entering into such third party license, Licensor has not exercised
its Discontinuation Option with respect to the Program to which
such Third Party IP relates; or (2) be shared by the Parties in
amounts and/or percentages to be agreed upon by the Parties prior
to Licensor entering into such third party license, if such Third
Party IP relates (but does not relate solely) to the composition of
matter, use, manufacture, formulation or exploitation of Products
within Program(s) for which Licensor has not exercised its
Discontinuation Option and also relates to either (x) the
composition of matter, use, manufacture, formulation or
exploitation of Products within Program(s) for which Licensor has
exercised its Discontinuation Option or (y) the composition of
matter, use, manufacture, formulation or exploitation of other
products of Licensor; or (3) be borne fully by Licensor if such
Third Party IP relates solely to the composition of matter, use,
manufacture, formulation or exploitation of Product(s) within a
Program(s) for which Licensor has exercised its Discontinuation
Option. Notwithstanding the foregoing, Licensor shall have no
obligation to obtain any such third party licenses under this
Agreement or, in the event that Symphony GenIsis does not give such
consent, to grant any sublicenses to Symphony GenIsis. Upon
obtaining a license to such Third Party IP and the right to
sublicense to Symphony GenIsis, the Parties will, as necessary,
promptly amend this Agreement to include such sublicensed
intellectual property within the
5
license granted hereunder, incorporate any other
limitations, royalties or other provisions required by such third
party with respect to such sublicense, and address Symphony
GenIsis’ rights (if any) with respect to patent prosecution,
maintenance and enforcement of patents and patent applications
within such Third Party IP.
2.10.
Separate Third Party License for Discontinued Program
. In the event of the expiration of a Discontinuation Option
without exercise by Licensor, Symphony GenIsis has the right to
transfer to a third party Symphony GenIsis’ rights to the
Products relating to the Program to which such Discontinuation
Option pertained (the “ Discontinued Program
”). If Symphony GenIsis identifies a third party that
wishes to obtain such rights, then upon Symphony GenIsis’
request, (i) Licensor and Symphony GenIsis shall amend this
Agreement to terminate all of Symphony GenIsis’ rights and
obligations to the extent applicable to the Discontinued Program
and (ii) Licensor shall enter into a separate license agreement
with such third party in which all of such terminated rights and
obligations shall be conferred upon and undertaken by such third
party. The terms and conditions of such license agreement
shall be identical to those contained herein, to the extent that
such terms are applicable to the Discontinued Program and not
dependent on any Operative Document other than this
Agreement. Such terms shall include but not be limited to (1)
provisions allowing for termination of such license agreement upon
a material, uncured breach of such license agreement by the third
party on similar terms as provided herein with respect to Symphony
GenIsis and (2) a confidentiality provision that is not dependent
on any of the Operative Documents. Termination of this
Agreement shall not effect such license agreement and
Licensor’s obligation to enter into such a license agreement
shall survive termination of this Agreement.
2.11.
Supply of Materials After Expiration or Termination of Term
. In the event of an unexercised expiration or termination of
the Purchase Option, Licensor agrees to negotiate in good faith,
and on commercially reasonable terms and conditions, a supply
agreement relating to materials, including compounds and Products,
required by Symphony GenIsis (or its partners or transferees
hereunder) for the continued development (including clinical
development), manufacture and commercialization of
Products.
ARTICLE 3
SUBLICENSE TO CERTAIN THIRD PARTY INTELLECTUAL
PROPERTY
3.1.
Third Party Sublicense Payments . Unless otherwise
agreed to by the Parties in writing, to the extent that (a) any
Licensed Patent Rights are licensed to Licensor by a third party
and sublicensed to Symphony GenIsis by Licensor hereunder or (b) a
third party has previously collaborated with Isis with respect to
GCCR or GCGR, and the development, manufacture, use, sale or other
commercialization of any Product by Symphony GenIsis shall require
the Licensor to make a royalty payment, milestone or any other
payment obligation to the third party licensor of such Licensed
Intellectual Property or previous collaborator, (i) Symphony
GenIsis shall be responsible for the satisfaction of such royalty
payment, milestone or any other obligation to such licensor if such
payment is triggered by the development, manufacture, use, sale or
other commercialization of any Product by Symphony GenIsis; or (ii)
such royalty payment shall be shared by the Parties in amounts
and/or percentages to be agreed upon by the Parties if such payment
relates (but does not relate solely) to the manufacture, use, sale
or other commercialization of any Product by Symphony
GenIsis. Notwithstanding the foregoing, with
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respect to agreements between Isis and any third
party existing as of the Closing Date, Symphony GenIsis’
obligations under this Section 3.1 for Products [***].
3.2.
Sublicensed Intellectual Property . Symphony GenIsis
acknowledges (i) that certain Licensed Intellectual Property is
licensed to Licensor by third parties and will be sublicensed to
Symphony GenIsis hereunder (the “ Sublicensed
Intellectual Property ”) and (ii) that such
sublicense is subject to certain restrictions and obligations set
forth in the applicable written agreements between Licensor and
such third parties (the “ Sublicense
Obligations ”), including but not limited to those
restrictions and obligations set forth on Schedule 2.2.
Symphony GenIsis agrees to either be bound by the Sublicense
Obligations or forfeit the applicable sublicense of such
Intellectual Property under Section 2.2 subject to the applicable
Sublicense Obligation and sublicensed hereunder; provided, however,
that Symphony GenIsis cannot use this Section to avoid any
Sublicense Obligation that has accrued prior to the date Symphony
GenIsis elects to forfeit the applicable sublicense.
ARTICLE 4
INTELLECTUAL PROPERTY
4.1.
Ownership . The Parties acknowledge and agree that, as
between Licensor and Symphony GenIsis, and subject to Schedule 2.2,
Licensor or its licensors are the owners of all right, title and
interest in and to the Licensed Intellectual Property, including
without limitation Symphony GenIsis Enhancements. Symphony
GenIsis hereby assigns to Licensor all of Symphony GenIsis’
rights and interests in any Symphony GenIsis Enhancements,
including any rights in inventions made jointly by Licensor and
Symphony GenIsis. Symphony GenIsis shall promptly disclose
any Symphony GenIsis Enhancement to Licensor, and shall use
reasonable efforts, at Licensor’s request and at no cost to
Licensor, to cooperate fully with Licensor to transfer such
Symphony GenIsis Enhancements to Licensor.
4.2.
Marking . Symphony GenIsis shall mark, and shall cause
all of its sublicensees to mark, all Products, or the packaging
thereof or materials related thereto, with the number of the
applicable patents licensed hereunder in accordance with applicable
U.S. patent law.
4.3.
Prosecution and Maintenance.
(a) Unless otherwise set
forth in this Section 4.3, (i) Licensor shall prepare, file,
prosecute and maintain those patents and patent applications in
Licensed Patent Rights for which Licensor has patent prosecution
and maintenance rights; and (ii) Licensor shall provide Symphony
GenIsis with (1) quarterly reports regarding the status of the
prosecution and maintenance of Program-Specific Patents, (2) copies
of and/or access to any patent documents related to the Licensed
Patent Rights as reasonably requested by Symphony GenIsis, (3)
copies of patent applications and other substantive patent
prosecution documents pertaining to the Program-Specific Patents
prior to filing in the United States so as to afford Symphony
GenIsis and its patent counsel, at Symphony GenIsis’ expense,
a reasonable opportunity to review and comment on such documents
and (4) timely answers to Symphony GenIsis’ questions
regarding the status of patents and patent applications in Licensed
Patent Rights.
7
(b) Licensor will use
commercially reasonable efforts to seek the allowance of broad
generic claims, consistent with Licensor’s determination of
enforceability, business considerations and other
factors.
(c) Subject to any such
costs paid by Third Party Licensors and a reasonable allocation of
costs, to the extent that the Program-Specific Patents relate to
Licensor’s business other than the Programs, the cost of the
prosecution and maintenance of Program-Specific Patents shall be
paid by Symphony GenIsis. Upon the scope of any Licensed
Patent Rights being amended so that the patent or patent
application’s claims no longer relate to, or are exploitable
in connection with, any Product and/or any Program, for which
Licensor has not exercised a Discontinuation Option, such patent or
patent application shall cease to be a Licensed Patent Right and
all rights and obligations with respect to such patent or patent
application (including costs, fees, prosecution, maintenance and
enforcement) shall revert to Licensor.
(d) Symphony GenIsis
shall not be responsible for the costs of any opposition,
interference or reexamination initiated by Licensor with respect to
the Program Specific Patents (except to the extent allocated in the
Development Budget), unless the Parties mutually agree in writing
(i) that it is reasonably necessary or useful to file and prosecute
such opposition, interference or re-examination in connection with
such Program Specific Patents to protect their interests in such
Program Specific Patents and (ii) to a reasonable allocation of
costs to the extent that the Program Specific Patents relate to
Licensor’s business other than the Programs, which agreement
will not be unreasonably withheld or delayed. In the event,
however, that (i) Symphony GenIsis does not agree to pay such
costs (or its share of costs as reasonably allocated as set forth
above) of such opposition, interference or reexamination and (ii)
Licensor successfully files and prosecutes or settles such
opposition, interference or reexamination at its sole cost, then
the licenses granted by Licensor to Symphony GenIsis in Section 2.2
herein shall immediately terminate with respect to specific Program
Specific Patent subject to such opposition, interference or
reexamination.
(e) Each Party shall
provide the prosecuting Party with reasonable cooperation under
this Section 4.3.
4.4.
Abandonment . Subject to the limitations and
restrictions set forth on Schedule 2.2, the Parties acknowledge
that in the event Licensor desires to abandon any patent or patent
application covering Program-Specific Patents within the Major
Market during the Term or in any jurisdiction after the Term),
Licensor shall provide prompt, timely, prior written notice of at
least [***] days prior to abandonment thereof to Symphony GenIsis
before any such abandonment. If Symphony GenIsis informs
Licensor in writing at least [***] days before the relevant
abandonment deadline that Symphony GenIsis desires to avoid such
abandonment or lapse, then Licensor shall continue to prosecute or
maintain such patent or patent application at Symphony
GenIsis’ request and sole expense.
4.5.
Infringement . Each Party agrees to immediately notify
the other Party upon becoming aware of any infringement,
misappropriation, illegal use or misuse of the Licensed
Intellectual Property in connection with Products in the Exclusive
Field and provide to the other Party all available evidence of such
infringement.
8
4.6.
Enforcement Right During Term .
(a) Except as provided
in Section 4.6(b), during the Term, Licensor has the first right,
but not the obligation, to take action against others in the
courts, administrative agencies or otherwise to prevent or
terminate infringement, misappropriation, illegal use or misuse of
the Licensed Patent Rights or other Licensed Intellectual
Property.
(b) During the Term,
Licensor has the first right, but not the obligation, to take
action against others to terminate or prevent a GenIsis Relevant
Action. The costs and expenses of any such action shall be
borne by Symphony GenIsis to the extent the action relates to a
GenIsis Relevant Action; provided, that Symphony GenIsis’
prior, written consent was obtained prior to the initiation of such
action, such consent not to be unreasonable withheld or
delayed. Symphony GenIsis shall, at its expense, cooperate
with and reasonably assist Licensor in any such action if so
requested by Licensor, and, upon Licensor’s request, execute,
file and deliver all documents and proof necessary for such
purpose, including being named as a party to such litigation if
requested by Licensor or if required by Law. Symphony GenIsis
shall have the right to participate and be represented by its own
counsel at its own expense in any such action, suit or proceeding
with respect to Licensed Patent Rights solely relating to Products
for which Licensor has not exercised the relevant Discontinuation
Option provided that Symphony GenIsis shall not enter into any
settlement or compromise of such action, suit or proceeding that
affects or concerns the validity, enforceability, or ownership of
any Licensed Patent Rights or other Licensed Intellectual Property
without the prior written consent of Licensor, which consent shall
not be unreasonably withheld or delayed. Licensor shall not
enter into any settlement or compromise of such action, suit or
proceeding that affects or concerns the validity, enforceability,
or ownership of any Licensed Patent Rights or other Licensed
Intellectual Property without the prior, written consent of
Symphony GenIsis, which consent shall not be unreasonably withheld
or delayed.
(c) Subject to the
limitations and restrictions set forth on Schedule 2.2, if, (1)
during the Term, Symphony GenIsis requests Licensor to take action
pursuant to Section 4.6(b) with respect to a GenIsis Relevant
Action that either (i) solely involves the enforcement of a Program
Specific Patent or (ii) involves the enforcement of other Licensed
Intellectual Property and there is not a claim of an issued Program
Specific Patent that covers the infringing ASO, and (2) Licensor
does not take such action within [***] days of Symphony
GenIsis’ written request that Licensor take such action, then
Symphony GenIsis shall have the option to commence any such action
under its own direction and control, and at Symphony GenIsis’
cost and expense. Licensor shall, at Symphony GenIsis’
expense, cooperate with and reasonably assist Symphony GenIsis in
any such action if so requested by Symphony GenIsis, and, upon
Symphony GenIsis’ request, execute, file and deliver all
documents and proof necessary for such purpose, including being
named as a party to such litigation if requested by Symphony
GenIsis or if required by Law. Licensor shall have the right
to participate and be represented by its own counsel at its own
expense in any such action, suit or proceeding with respect to
Licensed Patent Rights provided that Licensor shall not enter into
any settlement or compromise of such action, suit or proceeding
that affects or concerns the validity, enforceability, or ownership
of any Licensed Patent Rights or other Licensed Intellectual
Property without the prior written consent of Symphony GenIsis,
which consent shall not be unreasonably withheld or delayed.
Symphony GenIsis shall not enter into any settlement or compromise
of such action, suit or proceeding that
9
affects or concerns the validity,
enforceability, or ownership of any Licensed Patent Rights or other
Licensed Intellectual Property without the prior, written consent
of Licensor, which consent shall not be unreasonably withheld or
delayed.
4.7.
Post-Term Enforcement .
(a) Program Specific
Patents . Following the unexercised expiration or
termination of the Purchase Option without Licensor’s
exercise of the Purchase Option, as between the Parties, and solely
with respect to Program Specific Patents, Symphony GenIsis shall
have the first right, but not the obligation, to take action
against others to prevent or terminate GenIsis Relevant
Actions. Licensor shall, at Symphony GenIsis’ expense,
cooperate and reasonably assist Symphony GenIsis in such action if
so requested, and upon Symphony GenIsis’ request, execute,
file and deliver all documents and proof necessary for such
purpose, including being named as a party to such litigation if
requested by Symphony GenIsis or if required by Law. Licensor
shall have the right to participate and be represented in any such
action, suit or proceeding by its own counsel at its own expense
provided that Licensor shall not enter into any settlement or
compromise of such action, suit or proceeding that affects or
concerns the validity, enforceability, or ownership of any Licensed
Patent Rights or other Licensed Intellectual Property without the
prior written consent of Symphony GenIsis, which consent shall not
be unreasonably withheld or delayed. Symphony GenIsis shall
not enter into any settlement or compromise of such action, suit or
proceeding that affects or concerns the validity, enforceability,
or ownership of any Licensed Patent Rights or other Licensed
Intellectual Property without the prior written consent of
Licensor, which consent shall not be unreasonably withheld or
delayed.
(b) Following the
unexercised expiration or termination of the Purchase Option
without Licensor’s exercise of the Purchase Option, if
Symphony GenIsis does not take action under Section 4.7(a) within
[***] days of Licensor’s written request that Symphony
GenIsis take such action, then Licensor shall have the option to
commence any such action under its own direction and control, and
at Licensor’s cost and expense. Symphony GenIsis shall,
at Licensor’s expense, cooperate and reasonably assist
Licensor in such action if so requested, and upon Licensor’s
request, execute, file and deliver all documents and proof
necessary for such purpose, including being named as a party to
such litigation if requested by Licensor or if required by
Law. Symphony GenIsis shall have the right to participate and
be represented in any such action, suit or proceeding by its own
counsel at its own expense provided that Symphony GenIsis shall not
enter into any settlement or compromise of such action, suit or
proceeding that affects or concerns the validity, enforceability,
or ownership of any Licensed Patent Rights or other Licensed
Intellectual Property without the prior written consent of
Licensor, which consent shall not be unreasonably withheld or
delayed. Licensor shall not enter into any settlement or
compromise of such action, suit or proceeding that affects or
concerns the validity, enforceability, or ownership of any Licensed
Patent Rights or other Licensed Intellectual Property without the
prior written consent of Symphony GenIsis, which consent shall not
be unreasonably withheld or delayed.
(c) Licensed
Intellectual Property . Except as set forth in Section
4.7(a) and 4.7(b) above, following the unexercised expiration or
termination of the Purchase Option without Licensor’s
exercise of the Purchase Option, as between the Parties, Licensor
shall have the first
10
right, but not the obligation, to take action
against others in the courts, administrative agencies or otherwise,
under Licensor’s direction and control and at
Licensor’s cost and expense, to prevent or terminate
infringement, misappropriation, illegal use or misuse of any
Licensed Intellectual Property, including but not limited to a
GenIsis Relevant Action. Symphony GenIsis shall, at
Licensor’s expense, cooperate and reasonably assist Licensor
in such action if so requested, and upon Licensor’s request,
execute, file and deliver all documents and proof necessary for
such purpose, including being named as a party to such litigation
if requested by Licensor or if required by Law. Symphony
GenIsis shall have the right to participate and be represented in
any such action, suit or proceeding by its own counsel at its own
expense provided that Symphony GenIsis shall not enter into any
settlement or compromise of such action, suit or proceeding that
affects or concerns the validity, enforceability, or ownership of
any Licensed Patent Rights or other Licensed Intellectual Property
without the prior written consent of Licensor, which consent shall
not be unreasonably withheld or delayed. Licensor shall not
enter into any settlement or compromise of such action, suit or
proceeding that affects or concerns the validity, enforceability,
or ownership of any Licensed Patent Rights or other Licensed
Intellectual Property without the prior written consent of Symphony
GenIsis, which consent shall not be unreasonably withheld or
delayed.
(d) Except as set forth
in Section 4.7(a) and 4.7(b) above and subject to the limitations
and restrictions set forth on Schedule 2.2, following the
unexercised expiration or termination of the Purchase Option
without Licensor’s exercise of the Purchase Option, if
Licensor does not take action under Section 4.7(c) with respect to
a GenIsis Relevant Action within [***] days of Symphony
GenIsis’ written request that Licensor take such action, then
Symphony GenIsis shall have the option to commence any such action
under its own direction and control, and at Symphony GenIsis’
cost and expense. Licensor shall, at Symphony GenIsis’
expense, cooperate and reasonably assist Symphony GenIsis in such
action if so requested, and upon Symphony GenIsis’ request,
execute, file and deliver all documents and proof necessary for
such purpose, including being named as a party to such litigation
if requested by Symphony GenIsis or if required by Law.
Licensor shall have the right to participate and be represented in
any such action, suit or proceeding by its own counsel at its own
expense provided that Licensor shall not enter into any settlement
or compromise of such action, suit or proceeding that affects or
concerns the validity, enforceability, or ownership of any Licensed
Patent Rights or other Licensed Intellectual Property without the
prior written consent of Symphony GenIsis, which consent shall not
be unreasonably withheld or delayed. Symphony GenIsis shall
not enter into any settlement or compromise of such action, suit or
proceeding that affects or concerns the validity, enforceability,
or ownership of any Licensed Patent Rights or other Licensed
Intellectual Property without the prior written consent of
Licensor, which consent shall not be unreasonably withheld or
delayed.
4.8.
Withdrawal of Enforcement . If either Party brings an
action under this ARTICLE 4 with respect to a GenIsis Relevant
Action and subsequently ceases to pursue or withdraws from such
action without resolution (which resolution may include the
granting of a license by Isis to such third party that does not
violate Section 2.2 or Section 2.6 of this Agreement), it shall
promptly notify the other Party and the other Party may, to the
extent permitted by Law, substitute itself for the withdrawing
party under the terms of this ARTICLE 4.
11
4.9.
Recoveries . All damages or other compensation of any
kind recovered in such action, suit, or proceeding or from any
settlement or compromise brought under this ARTICLE 4 shall first
be used to reimburse each Party for its expenses in connection with
such action, suit or proceeding, (in proportion to the expenses of
each Party if recovery is insufficient to cover all such expenses)
and the remainder of such recovery, shall be allocated [***] to the
Party hereto taking the lead in the action, suit or
proceeding.
ARTICLE 5
REPRESENTATIONS AND WARRANTIES
5.1.
Representations and Warranties of Licensor . Licensor
hereby represents and warrants to Symphony GenIsis, that, as of the
Closing Date:
(a) Subject to Section
3.2 and Schedule 2.2, Licensor is the exclusive owner of all right,
title, and interest in and to (i) all Licensed Patent Rights
and not identified as jointly owned or licensed from a third party
and (ii) the Regulatory Files;
(b) Licensor has
sufficient rights to grant the licenses granted hereunder and the
grant of such licenses does not and will not conflict with any
agreement to which Licensor is a party or otherwise governing the
Licensed Intellectual Property and Licensor further represents and
warrants that, on an ongoing basis throughout the Term, Licensor
shall not enter into any agreement that will conflict with the
rights and licenses granted to Symphony GenIsis
hereunder;
(c) To the Knowledge of
Licensor, no third party is engaging in any activity that infringes
or misappropriates the Program-Specific Patents or related know-how
or trade secrets;
(d) No element of the
Licensed Intellectual Property has been adjudged invalid or
unenforceable in whole or part, and to the Knowledge of Licensor,
the issued patents within the Licensed Intellectual Property are
valid and enforceable;
(e) To the Knowledge of
Licensor, no actions or claims have been asserted, are pending or
have been threatened, against Licensor in writing alleging that the
manufacture, use or sale of any Product misappropriates or
infringes the intellectual property rights of any third
party;
(f) Except as set
forth on Annex D, Licensor and/or Symphony GenIsis shall not be
liable or otherwise obligated to pay royalties, milestone payments
or other consideration pursuant to any agreement Licensor may have
with a third party existing on the Closing Date in connection with
Symphony GenIsis’ exploitation of the Licensed Intellectual
Property (including Sublicensed Intellectual Property) in
connection with the development, manufacture, use, sale, or
importation of Products [***] hereunder; and
(g) To the Knowledge of
Licensor, the manufacture, use or sale of any Product [***] by
Symphony GenIsis (or its sublicensees) in strict accordance with
the licenses herein and other terms of this Agreement will not
misappropriate or infringe the intellectual property rights of any
third party.
12
5.2.
Disclaimer and Acknowledgement . EXCEPT AS EXPRESSLY
SET FORTH IN THIS ARTICLE 5, THE LICENSED INTELLECTUAL PROPERTY,
PRODUCTS, TANGIBLE MATERIALS AND REGULATORY FILES ARE PROVIDED
“AS IS” WITH NO REPRESENTATIONS OR WARRANTIES OF ANY
KIND, AND LICENSOR EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES,
EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF
MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, OR
NON-INFRINGEMENT. LICENSOR DOES NOT WARRANT THE PERFORMANCE
OF ANY PRODUCT, INCLUDING THEIR SAFETY, EFFECTIVENESS OR COMMERCIAL
VIABILITY. ANY SYMPHONY GENISIS ENHANCEMENTS PROVIDED TO
LICENSOR HEREUNDER ARE PROVIDED “AS IS” WITH NO
REPRESENTATIONS OR WARRANTIES OF ANY KIND AND SYMPHONY GENISIS
EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING
BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR
PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
ARTICLE 6
INDEMNIFICATION AND LIMITATION OF LIABILITY
6.1.
Indemnity . To the greatest extent permitted by
applicable Law, Licensor shall indemnify and hold harmless Symphony
GenIsis, its Affiliates, and each of their respective officers,
directors, employees, agents, members, managers, successors and
assigns (each, a “ Symphony GenIsis Indemnified
Party ”) and Symphony GenIsis shall indemnify and
hold harmless Licensor, its Affiliates and each of their respective
officers, director
