Exhibit 10.3
AMENDMENT NO. 2 TO
ADDENDUM RE: INFLUENZA PROGRAM TO
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This Amendment No. 2 to the Addendum re: Influenza Program to Research
Collaboration and License Agreement ("Amendment No. 2") is made and effective as
of May 5, 2006 (the "Amendment No. 2 Effective Date") by and between Novartis
Institutes for BioMedical Research, Inc., a corporation organized and existing
under the laws of Delaware, with its principal place of business at 000
Xxxxxxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("Novartis"), and Alnylam
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
Delaware, with its principal place of business at 000 Xxxxx Xxxxxx, 0xx Xxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("Alnylam").
RECITALS:
WHEREAS, Alnylam and Novartis entered into that certain Research
Collaboration and License Agreement effective as of October 12, 2005 (the
"Agreement");
WHEREAS, Alnylam and Novartis entered into that Addendum re: Influenza
Program to Research Collaboration and License Agreement effective as of February
17, 2006, as amended by Amendment No. 1 to Addendum re: Influenza Program to
Research Collaboration and License Agreement effective as of March 14, 2006 (the
"Addendum");
WHEREAS, in accordance with Section 9.6 of the Agreement, the Parties
desire to amend the Addendum as set forth herein;
NOW, THEREFORE, in consideration of the respective representations,
warranties, covenants and agreements contained herein, and for other valuable
consideration, the receipt and adequacy of which are hereby acknowledged,
Alnylam and Novartis agree as follows:
ARTICLE I
DEFINITIONS
1.1 For the purposes of this Amendment No. 2, capitalized terms, whether
used in the singular or plural form, shall have the respective meanings ascribed
to such terms in the Addendum, or, if not defined therein, in the Agreement.
ARTICLE II
PANDEMIC FLU JOINT STEERING COMMITTEE
2.1 Commercialization of Pandemic Products. The second (2nd) sentence of
Section 2.02 of the Addendum is hereby amended and restated in its entirety as
follows:
"Such Commercialization, including sales to the USG or an agency thereof, will
be led by Novartis worldwide and shall be overseen by the Pandemic Flu Joint
Steering Committee; provided, however, that the Parties agree that Alnylam shall
have the right, but not the
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obligation, to (a) be actively involved in such Commercialization in the United
States and (b) take the lead in certain aspects of such Commercialization in the
United States if it is in the best interests of the Pandemic Flu Program as
approved by the Pandemic Flu Joint Steering Committee."
2.2 Governance in General.
2.2.1 The second (2nd) sentence of Section 3.01(b) of the Addendum is
hereby amended and restated in its entirety as follows:
"In addition, except as provided in Section 3.01(e), the Pandemic Flu Joint
Steering Committee will be responsible for arrangements relating to the
Development, Commercialization and Manufacture of Pandemic Products, taking into
account any pre-existing Manufacturing relationships as set forth on Schedule B
hereto."
2.2.2 Section 3.01(c) of the Addendum is hereby amended by inserting
the following sentence at the end thereof:
"Alnylam will participate on the Pandemic Flu Joint Steering Committee until
Commercialization of the first Pandemic Product. Upon Commercialization of the
first Pandemic Product, Alnylam will have the right but not the obligation to
participate on the Pandemic Flu Joint Steering Committee."
2.2.3 The first (1st) sentence of Section 3.01(d) of the Addendum is
hereby amended by inserting the following clause immediately prior to the start
of such sentence:
"Except as provided in Section 3.01(e),"
2.2.4 Section 3.01 of the Addendum is hereby amended by inserting the
following as new Section 3.01(e):
"(e) If, at any time after the Commercialization of the first
Pandemic Product, Alnylam does not participate on the Pandemic Flu Joint
Steering Committee, then the Pandemic Flu Joint Steering Committee shall not
have the right to decide any matter that relates to the choice of Novartis or
one of its Affiliates to Manufacture any Pandemic Product if the cost structure
offered by Novartis or such Affiliate differs significantly and adversely from
the bona fide cost structure available from a Third Party able to Manufacture
such Pandemic Product at substantially equivalent quality and Novartis shall
only be so chosen if mutually agreed upon by the Parties. Any dispute between
the Parties with respect to such matter shall be referred to the Executive
Officers for resolution. If such matter is not resolved by the Executive
Officers within fifteen (15) days after referral thereto, then either Party may
seek any and all remedies available under law or equity with respect to such
dispute."
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ARTICLE III
ADDITIONAL CONSIDERATION
3.1 Additional Consideration. In consideration for the execution of this
Amendment No. 2, Alnylam shall pay to Novartis the sum of one dollar ($1.00) on
the Amendment No. 2 Effective Date.
ARTICLE IV
MISCELLANEOUS
4.1 Effect on Addendum. Except as amended by this Amendment No. 2, the
Addendum, the Agreement, the CRT Sublicense Agreement and the Stock Purchase
Agreement shall remain in full force and effect.
4.2 Execution in Counterparts; Facsimile Signatures. This Amendment No. 2
may be executed in counterparts, each of which counterparts, when so executed
and delivered, shall be deemed to be an original, and all of which counterparts,
taken together, shall constitute one and the same instrument even if both
Parties have not executed the same counterpart. Signatures provided by facsimile
transmission shall be deemed to be original signatures.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, Alnylam and Novartis have caused this Amendment No. 2
to be duly executed by their authorized representatives, as of the date first
written above.
ALNYLAM PHARMACEUTICALS, INC.
By: /s/ Xxxxxxxx X. Xxxxx
---------------------------------------
Name: Xxxxxxxx X. Xxxxx
Title: VP, Finance and Treasurer
NOVARTIS INSTITUTES FOR BIOMEDICAL
RESEARCH, INC.
By: /s/ Xxxxxxxxx Xxxx
--------------------------------------
Name: Xxxxxxxxx Xxxx
Title: CFO
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