EXHIBIT 10.62
First Amendment to
the
License, Development, Supply and
Distribution Agreement
by and among
Allergan Sales, LLC, Allergan
USA, Inc., Allergan, Inc., and
Spectrum Pharmaceuticals,
Inc.
This FIRST AMENDMENT (the “
Amendment ”) TO THE LICENSE, DEVELOPMENT, SUPPLY AND
DISTRIBUTION AGREEMENT (the “ Agreement ”),
entered into as of April 20, 2009 (the “ Amendment
Effective Date ”), is made by and among Allergan Sales,
LLC, a Delaware corporation with its principal place of business at
2525 Dupont Drive, Irvine, California 92612 (“ Allergan
Sales ”), Allergan USA, Inc., a Delaware corporation with
its principal place of business at 2525 Dupont Drive, Irvine,
California 92612 (“ Allergan USA ”), Allergan,
Inc., a Delaware corporation with its principal place of business
at 2525 Dupont Drive, Irvine, California 92612 (“
Allergan, Inc. ” and, collectively with Allergan Sales
and Allergan USA, “ Allergan ”) and Spectrum
Pharmaceuticals, Inc. (“ Spectrum ”), a Delaware
corporation with its principal place of business at 157 Technology
Drive, Irvine, CA 92618.
RECITALS
WHEREAS, the Parties entered into
the Agreement as of October 28, 2008;
WHEREAS, under Section 5.5 of
the Agreement, the Parties agreed to enter into a pharmacovigilance
or adverse event reporting agreement within 60 days of the
Effective Date; and
WHEREAS, the Parties believe it is
in their collective best interests to amend the Agreement as it
relates to an adverse event reporting agreement;
NOW, THEREFORE, in consideration of
the foregoing recitals, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto agree as follows:
1. Definitions and
References . Except as set forth
herein, capitalized terms not otherwise defined or amended in the
Amendment shall have the meaning ascribed to them in the Agreement.
References to Articles or Sections are to the same with all of
their subparts as they appear in the Agreement.
2. Amendments to the
Agreement . Effective as of the
Amendment Effective Date, the Agreement shall be amended as set
forth in this Paragraph 2:
(a)
Section 5.5 of the Agreement is
hereby deleted in its entirety and replaced with the
following:
“Section
5.5
Pharmacovigilance . The Parties shall
begin negotiating an adverse event reporting agreement and safety
data exchange agreement (the “ SDEA ”) no later
than the date the first application for licensure for the Licensed
Product is submitted in any geography, and the Parties agree that
such SDEA will be executed and effective no later than thirty
(30) days prior to the first launch of the Licensed Product in
any geography. Furthermore, Allergan and Spectrum agree, for itself
and all current and future partnerships, collaborations, joint
ventures or other combinations (together, the “
Partnerships ”) it may enter into relating to the
Licensed Product during the term of the Agreement, to collaborate
on the execution of the SDEA meeting all regulatory requirements of
the Parties in all geographies. Allergan and Spectrum, for itself,
and any Partnerships, further agree that: 1) one global database
for safety post-marketing will be created for the Licensed Product
worldwide; 2) if a risk management plan and/or a risk evaluation
and mitigation strategy (together, “ REMS ”)
is/are required for the Licensed Product at any time, Spectrum and
Allergan agree to work together to ensure that the REMS meets all
regu
