FIRST AMENDMENT TO THE LICENSE
AND COLLABORATION AGREEMENT
This FIRST
AMENDMENT TO THE LICENSE AND COLLABORATION AGREEMENT (the
“ First Amendment ”) is entered into as of
February 10, 2009 (the “ First Amendment Effective
Date ”), by and between Valeant Pharmaceuticals North
America , a Delaware corporation having a place of business at
One Enterprise, Aliso Viejo, California 92656 (“
VALEANT ”) and Glaxo Group Limited , a company
organized under the laws of England and Wales with its principal
place of business at Glaxo Wellcome House, Berkeley Avenue,
Greenford, Middlesex, UB6 0NN, United Kingdom (“ GSK
”). VALEANT and GSK are each referred to herein individually
as a “ Party ” or, collectively, as the “
Parties .”
WHEREAS, the
Parties entered into that certain License and Collaboration
Agreement dated as of August 27, 2008 (the “
Collaboration Agreement ”) under which VALEANT and GSK
are collaborating on the development and commercialization of
VALEANT’S compound, Retigabine; and
B. WHEREAS,
the Parties desire to amend certain provisions of the Collaboration
Agreement, in particular, (i) to provide GSK with
decision-making authority with respect to development, regulatory
and manufacturing activities for the Product in the Territory prior
to the expiration of the Review Period; and (ii) to amend the
provisions in Section 11.3.4 with respect to the payment of
certain amounts by Valeant to GSK upon termination of the
Collaboration Agreement by GSK during the Review Period, all on the
terms and conditions set forth herein.
NOW, THEREFORE, in
consideration of the premises and mutual covenants herein
contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
Parties hereto agree as follows:
1.
Amendment of the Collaboration Agreement .
The Parties
hereby agree to amend the terms of the Collaboration Agreement as
provided below, effective as of the First Amendment Effective Date.
To the extent that the Collaboration Agreement is explicitly
amended by this First Amendment, the terms of this First Amendment
will control where the terms of the Collaboration Agreement are
contrary to or conflict with the following provisions. Where the
Collaboration Agreement is not explicitly amended, the terms of the
Collaboration Agreement will remain in full force and effect.
Capitalized terms used in this First Amendment that are not
otherwise defined herein shall have the same meanings ascribed to
them in the Collaboration Agreement.
PORTIONS OF THIS EXHIBIT HAVE BEEN
OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION (THE
“COMMISSION”).
THE OMISSIONS HAVE BEEN INDICATED BY ASTERISKS (“***”),
AND THE OMITTED TEXT HAS
BEEN FILED SEPARATELY WITH THE COMMISSION.
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2.
Amendments to Section 3.1
2.1 Section 3.1.7(a) is deleted in its entirety
and shall be of no further force of effect.
2.2 Section 3.1.7(b) is hereby renumbered as
“Section 3.1.7(a)” and amended in its entirety to
read as follows:
(a)
Impasse . Except as otherwise provided in
Section 2.2.2, this Section 3.1.7(a) and Section
3.1.7(b), if despite good faith efforts, the Senior Executives are
unable to resolve such matter within thirty (30) days of the
date of any Escalation Notice, then GSK may cast the deciding vote
on such matter (which shall become the decision of the Joint
Steering Committee); provided, however, that GSK cannot cast a
deciding vote with respect to any decision to enter into any
binding agreements relating to the manufacture of the Product or
Additional Products in the Field and in the Territory that do not
meet the criteria set forth in Section 1.3, but, rather, in
the case of the foregoing, VALEANT’s prior consent must be
obtained for such decision. For clarity, GSK shall have final
decision-making authority over any manufacturing issues, including
issues regarding ***. Notwithstanding the foregoing, in the event
of GSK’s termination of the Agreement, GSK’s
obligations regarding manufacture shall remain as set forth in
Section 11.2.2(g).
2.3 Section 3.1.7(c) is hereby renumbered as
“Section 3.1.7(b)”.
3.
Amendments to Section 3.2
3.1 Section 3.2.2 is hereby amended in its
entirety to read as follows:
3.2.2 The Joint
Steering Committee will oversee development of the Compound,
Additional Compounds, Products and Additional Products in
accordance with the Development Plans. Subject to
Sections 3.2.3 and 3.2.5, GSK shall use Commercially
Reasonable Efforts to carry out all clinical development and other
activities required to obtain Regulatory Approvals for the Products
and Additional Products in the Field and in the Territory and
Collaboration Territory, with the conduct and manner of
implementation of such activities determined in the reasonable
discretion of GSK consistent with the Development Plan and as
directed by the Joint Steering Committee. Subject to
Section 3.2.5, VALEANT shall use Commercially Reasonable
Efforts to carry out all clinical development and other activities
required to obtain Regulatory Approvals for the Product in the
Field in the Collaboration Territory, in accordance with the
then-current Development Plans and as directed by the Joint
Steering Committee. Subject to Sections 3.2.3 and 3.2.5, each
Party shall conduct those activities allocated to such Party under
the Development Plans in compliance in all material respects in
accordance with good scientific and clinical practices, and Laws
applicable in the country in which such activities are
conducted.
4.
Amendments to Section 3.3
4.1 Section 3.3.1 is hereby amended in its
entirety to read as follows:
PORTIONS OF THIS EXHIBIT HAVE BEEN
OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT FILED WITH THE SECURITIES AND EXCHANGE COMMISSION (THE
“COMMISSION”).
THE OMISSIONS HAVE BEEN INDICATED BY ASTERISKS (“***”),
AND THE OMITTED TEXT HAS
BEEN FILED SEPARATELY WITH THE COMMISSION.
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3.3.1 Prior to
the Expiration of the Review Period. Prior to the expiration of
the Review Period, GSK will be responsible for filing of all MAAs
and other filings with Regulatory Authorities in the Territory for
development, use, and commercialization of each Product and
Additional Products in the Territory, as directed by the Joint
Steering Committee and using Commercially Reasonable Efforts to
seek such approvals; provided , however , that prior
to the expiration of the Review Period, VALEANT will file the NDA
for the Product in the United States in its name. All such activity
of GSK and VALEANT shall be done in accordance with the direction
of the Joint Steering Committee. Other than the NDA, all filings
with Regulatory Authorities will be in the name of GSK, except
where otherwise required by applicable law in any country within
the Territory or as otherwise agr
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