AMENDMENT TO CO-EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.4
AMENDMENT TO CO-EXCLUSIVE LICENSE AGREEMENT
This Amendment to the Alnylam Co-Exclusive License Agreement is made as of March 14, 2011
(“Effective Date”), by and between Alnylam Pharmaceuticals, Inc. (“Alnylam”), on the one hand, and
Xxxxxxxxx Institute for Biomedical Research (“Xxxxxxxxx”), Massachusetts Institute of Technology
(“MIT”), and Max-Xxxxxx-Innovation GmbH (“MI”).
This agreement is made with respect to the following recitals:
WHEREAS, Alnylam and MI (at the time called Garching Innovation GmbH and referred to as GI in
the Alnylam Co-Exclusive License Agreement) are parties to the Alnylam Co-Exclusive License
Agreement;
WHEREAS, Xxxxxxxxx and MIT joined the Alnylam Co-Exclusive License Agreement on July 30, 2003;
WHEREAS, the Alnylam Co-Exclusive License Agreement grants, among other things, a license to
the “XXX XXXXXX PATENT RIGHTS” (as that term is defined in the Alnylam Co-Exclusive License
Agreement) to Alnylam, subject to the terms and conditions of the Alnylam Co-Exclusive License
Agreement;
WHEREAS, pursuant to that certain Assignment Agreement made and entered into as of March 14,
2011, MIT and Xxxxxxxxx have become co-owners of the XXX XXXXXX PATENT RIGHTS in the US;
WHEREAS, the purpose of this Amendment is to reflect that MIT and Xxxxxxxxx have become
co-owners of the XXX XXXXXX PATENT RIGHTS in the US and to amend the Alnylam Co-Exclusive License
Agreement accordingly;
WHEREAS, MIT and Xxxxxxxxx have the right to grant licenses under the XXX XXXXXX PATENT RIGHTS
in the US;
WHEREAS, Alnylam desires to obtain licenses with the right to grant sublicenses under the XXX
XXXXXX PATENT RIGHTS in the US, and MIT and Xxxxxxxxx desire to grant such licenses subject to the
conditions set forth herein;
NOW, THEREFORE, Alnylam, on one hand, and each of MIT, Xxxxxxxxx, and MI, on the other, hereby
agree as follows:
1. Definitions. The following words and phrases shall have the meanings set forth below
solely for purposes of this Amendment, including the recitals above.
1.1. All capitalized terms not defined herein shall have the meaning set forth in the Alnylam
Co-Exclusive License Agreement.
1.2. “Amendment” shall mean this Amendment to the Alnylam Co-Exclusive License Agreement.
1.3. “Alnylam Co-Exclusive License Agreement” shall mean the Co-Exclusive License Agreement
originally executed on December 20, 2002, and subsequently amended, that grants therapeutic rights
to the JOINT PATENT RIGHTS and the XXX XXXXXX PATENT RIGHTS to Alnylam subject to the terms and
conditions of that license agreement as amended.
2. Amendment to Alnylam Co-Exclusive License Agreement. The Parties agree that the Alnylam
co-Exclusive License Agreement shall be amended as follows:
2.1. The second “WHEREAS” clause shall be amended to begin: “WHEREAS, MAX-XXXXXX is the sole
owner of certain XXX XXXXXX PATENT RIGHTS outside of the USA, and MAX-XXXXXX, XXXXXXXXX and M.I.T.
are the co-owners of certain XXX XXXXXX PATENT RIGHTS in the USA...”
2.2. The fifth “WHEREAS” clause shall be amended to state: “WHEREAS, XXXXXXXXX and M.I.T. have
authorized GI to act as their agent for the purposes of licensing the JOINT PATENT RIGHTS and the
XXX XXXXXX PATENT RIGHTS (including XXXXXXXXX’x and M.I.T.’s co-ownership rights in the XXX XXXXXX
PATENT RIGHTS in the USA) for therapeutic purposes, and therefore, this Agreement is binding on
each of XXXXXXXXX and M.I.T.”
2.3. Section 2.1 shall be amended to read as follows:
2.1 License Grant. MIT, XXXXXXXXX and GI grant to COMPANY for the TERM a
worldwide royalty-bearing co-exclusive license, with the right to grant sublicenses, under
the PATENT RIGHTS to develop, make, have made, use, sell and import LICENSED PRODUCTS in
the FIELD. MIT, XXXXXXXXX and GI grant to COMPANY for the TERM a worldwide royalty-bearing
non-exclusive license, without the right to grant sublicenses, under the PATENT RIGHTS to
develop, make, have made, use, sell and import LICENSED PRODUCTS for all diagnostic uses
other than for purposes of therapeutic monitoring.
2.4. The Heading of Section 6.3 shall be amended to read as follows: “6.3 Infringement of
JOINT PATENT RIGHTS.
2.5. Section 6.3 shall be amended by adding the following at the beginning of the section,
immediately following the heading: “This Section shall govern infringement or possible infringement
of the JOINT PATENT RIGHTS.
2.6. A new section shall be added after section 6.3 that reads as follows: “6.4 Infringement
of XXX XXXXXX PATENT RIGHTS.”
2.7. The following sections 6.4.1. through 6.4.5. shall be added:
“6.4.1. Notice. Each Party shall notify the other Parties promptly in
writing of any infringement of any XXX XXXXXX PATENT RIGHTS that becomes known to any of
them, including without limitation the receipt of any Paragraph IV notice letter under the
Drug Price Competition and Patent Term Restoration Act of 1984
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(commonly referred to as the Xxxxx-Xxxxxx Act). In no event shall such notice be
given more than 60 calendar days after learning of any infringement.
6.4.2. Control of Patent Litigation. GI, M.I.T. and XXXXXXXXX agree that
COMPANY may bring suit for infringement of any claim of the XXX XXXXXX PATENT RIGHTS within
the FIELD, to enjoin infringement, to collect damages, profits and awards of whatever
nature recoverable for such infringement, to defend against any challenge to validity of
such patent, and to pursue any such litigation until a final judgment, from which no
further appeal may be taken and no further review may be sought. Alnylam shall reasonably
consult with M.I.T. and XXXXXXXXX and keep them informed concerning developments in the US
Commercial Litigation.
(a) M.I.T. and XXXXXXXXX agree not to contest being joined as necessary parties by
motion or being named as co-plaintiffs upon reasonable prior notice, if necessary to
establish standing or subject matter jurisdiction, in any patent litigation brought in the
United States against a for-profit commercial entity (the “US Commercial Infringement
Litigation”), provided that the complaint satisfies all pleading obligations and the
requirements of Rule 11 of the Federal Rules of Civil Procedure. Subject to Section
6.4.2(b), COMPANY shall have sole and exclusive control over all decisions in any such US
Commercial Infringement Litigation except that COMPANY shall give good faith consideration
to the views of M.I.T. and XXXXXXXXX concerning the selection of counsel for any US
Commercial Infringement Litigation or any settlement of any US Commercial Infringement
Litigation.
(b) In the event there arises an actual or potential conflict of interest between
M.I.T. and/or XXXXXXXXX on the one hand (the “Conflicted Party”), and Alnylam on the other
hand, with respect to the US Commercial Infringement Litigation such that representation of
the Conflicted Party by the counsel retained by COMPANY is inappropriate, the Conflicted
Party shall be entitled to select its own counsel, which counsel shall be paid for by the
Conflicted Party and not by COMPANY. Thereafter, COMPANY shall obtain the consent of the
Conflicted Party to settle the US Commercial Infringement Litigation, which consent shall
not be unreasonably withheld.
6.4.3. Fees. Subject to Section 6.4.2(b) above, any and all fees, costs and
expenses incurred by COMPANY, M.I.T., XXXXXXXXX, and/or GI including, without limitation,
attorney’s fees, court costs and disbursements, in connection with any action taken under
this Section 6.4 shall be paid by, and be the sole responsibility of, COMPANY.
6.4.4. Cooperation. M.I.T., XXXXXXXXX, and GI shall cooperate fully with
COMPANY in connection with any action under this Section 6.4 and agree to promptly provide
reasonable access to all necessary documents, information, and persons under their control,
and to render reasonable assistance in response to a request by COMPANY for such
assistance, all at the Company’s expense.
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6.4.5. Consent. None of M.I.T., XXXXXXXXX, or GI shall be entitled to bring
a suit for infringement of any XXX XXXXXX PATENT RIGHTS within the FIELD without the
express written consent of COMPANY, which COMPANY may withhold in its sole discretion.”
3. No Additional Rights. Nothing in this Amendment shall be construed to confer any rights
upon Alnylam by implication, estoppel, or otherwise as to any intellectual property rights,
including without limitation patents and patent applications, trademarks, copyrights and know-how,
of MIT or Xxxxxxxxx other than the XXX XXXXXX PATENT RIGHTS in the US, regardless of whether such
intellectual property rights shall be dominant or subordinate to any patent application or patent
in the XXX XXXXXX PATENT RIGHTS in the US within the FIELD.
4. Miscellaneous Provisions.
4.1. Non-Use of Owners’ Trademarks. Neither Alnylam nor its Affiliates and
Sublicensees shall use the name of “Massachusetts Institute of Technology,” “Xxxxxxxxx Institute,”
or “University of Massachusetts,” or any variation, adaptation, or abbreviation thereof, or of any
of its trustees, officers, faculty, students, employees, or agents, or any trademark owned by any
of them, in any promotional material or other public announcement or disclosure, without the prior
written consent of the respective institution or in the case of an individual, the consent of that
individual. The foregoing notwithstanding, Alnylam may state generally that it is exclusively
licensed by MIT and/or Xxxxxxxxx, under the XXX XXXXXX PATENT RIGHTS in the US within the FIELD.
4.2. Termination. MIT and Xxxxxxxxx agree that this Amendment (including the license
granted under Section 2.1) is non-revocable and cannot be terminated under any circumstances,
except in the event of a termination of the Alnylam Co-Exclusive License Agreement pursuant to the
provisions of Article 11 of the Alnylam Co-Exclusive License Agreement, which termination shall
automatically terminate this Amendment.
4.3. Notices. Any notices required or permitted under this Amendment and all
correspondence hereunder shall be in English and in writing, shall specifically refer to this
Amendment, and shall be sent by a method providing confirmation of delivery to the following
addresses or facsimile numbers of the parties:
Notices as described above shall be provided to the following:
If to Xxx Xxxxxx:
Managing Director
Xxx Xxxxxx Innovation GmbH
Xxxxxxxxxx. 00
00000 Xxxxxx
Xxxxxxx
Xxx Xxxxxx Innovation GmbH
Xxxxxxxxxx. 00
00000 Xxxxxx
Xxxxxxx
If to Alnylam:
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If to MIT:
Massachusetts Institute of Technology
00 Xxxxxxxxxxxxx Xxx.
Xxxxxxxxx, XX 00000-0000
Attn: Office of the General Counsel
00 Xxxxxxxxxxxxx Xxx.
Xxxxxxxxx, XX 00000-0000
Attn: Office of the General Counsel
If to WHITEHEAD:
Vice President
Xxxxxxxxx Institute
Nine Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Xxxxxxxxx Institute
Nine Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
4.4. Governing Law. This Amendment, and all disputes arising out of or related to
such sections of this Amendment, or the performance, enforcement, breach or termination hereof, and
any remedies relating thereto, shall be construed, governed, interpreted and applied in accordance
with section 12.2 (Governing Law) of the Alnylam Co-Exclusive License Agreement.
4.5. Integration. This Amendment supersedes all prior written agreements and all
prior written and contemporaneous oral agreements with respect to the subject matter hereof, except
the Alnylam Co-Exclusive License Agreement, which, as amended by this Agreement, remains in full
force and effect.
4.6. Amendment and Waiver. This Amendment may be amended, supplemented, or otherwise
modified only by means of a written instrument signed by all parties. Any waiver of any rights or
failure to act in a specific instance shall relate only to such instance and shall not be construed
as an agreement to waive any rights or fail to act in any other instance, whether or not similar.
4.7. Severability. Should one of the provisions of this Amendment be held void,
invalid or unenforceable, the remaining provisions of this Amendment will not cease to be
effective. The parties shall negotiate in good faith to replace such void, invalid or
unenforceable provision by a new provision which reflects, to the extent possible, the original
intent of the parties.
4.8. Headings. All headings are for convenience only and shall not affect the meaning
of any provision of this Amendment.
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4.9. Dispute Resolution. The parties agree that any dispute or claim that arises
between or among them relating to or arising out of this Amendment, will be considered a dispute or
claim arising out of the Alnylam Co-Exclusive License Agreement and it shall be subject to the
procedures set forth in Section 12.3 of the Alnylam Co-Exclusive Agreement.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized
representatives.
| ALNYLAM PHARMACEUTICALS, INC. | ||||||
| By: | /s/ Xxxxx Xxxxxx | |||||
| Its: | President and Chief Operating Officer | |||||
| MASSACHUSETTS INSTITUTE OF TECHNOLOGY | ||||||
| By: | R. Xxxxxxx Xxxxxx | |||||
| Its: | VP & General Counsel | |||||
| XXXXXXXXX INSTITUTE FOR BIOMEDICAL RESEARCH | ||||||
| By: | /s/ Xxxxxx X. Xxxxxxx | |||||
| Its: | Vice President | |||||
| XXX XXXXXX INNOVATION | ||||||
| By: | /s/ Xxx Xxxxxx | |||||
| Its: | Managing Director | |||||
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