Exhibit 10.46.1
The confidential portions of this exhibit have
been filed separately with the Securities and Exchange Commission
pursuant to a confidential treatment request in accordance with
Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.
REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN
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TERMINATION
AGREEMENT
This Termination Agreement
(“Termination Agreement”) is dated as of
February 24, 2006, by and between Noven Pharmaceuticals, Inc.,
a Delaware corporation (“Noven”), and Endo
Pharmaceuticals, Inc., a Delaware corporation (“Endo”).
Noven and Endo are collectively referred to as
“Parties” and individually as
“Party.”
RECITALS
WHEREAS, the Parties entered into an
agreement dated February 25, 2004 (“License
Agreement”) related to the exclusive distribution of certain
fentanyl transdermal patch products (“Licensed
Product”);
WHEREAS, the Parties entered into a
supply agreement dated as of February 25, 2004 ( “Supply
Agreement”) and an intercompany quality control agreement
dated as of February 25, 2004 ( “Quality
Agreement”) relating to the Licensed Product;
WHEREAS, the Parties further agreed
that they would work together with respect to certain additional
products using Noven’s transdermal patch technology
(“Additional Products”), as more particularly described
in the License Agreement;
WHEREAS, the Food & Drug
Administration (“FDA”) advised Noven on
September 27, 2005 that the FDA would not approve the Licensed
Product based on the FDA’s assessment of potential safety
concerns related to the higher drug content in the Licensed
Product;
WHEREAS, the Parties mutually desire
to terminate the Supply Agreement and Quality Control Agreement and
wish to terminate the License Agreement with respect to the
Licensed Product as set forth below; and
WHEREAS, the Parties desire that the
License Agreement survive with respect to the Additional Products,
with certain modifications as described herein; and
Termination Agreement Signature
Page
1
WHEREAS, this Agreement memorializes
the understandings of the parties with respect to the subject
matter hereof as of December 31, 2005 (the “Effective
Date”).
NOW, THEREFORE, in consideration of
the foregoing premises, and of the mutual promises and covenants
contained in the Termination Agreement, and for other good and
valuable consideration, the receipt and sufficiency of which is
hereby acknowledged, Noven and Endo agree as follows:
Article 1. Definitions.
Capitalized terms used herein shall
have the meaning as provided in the License Agreement, unless as
otherwise set forth below.
Article 2. Termination of Rights and Obligations
with Respect to Licensed Product.
2.1 Generally. The Parties mutually
agree to, and hereby do, terminate in their entirety the Supply
Agreement and the Quality Agreement, and all of the Parties’
respective rights and obligations thereunder, if any, shall
terminate as of the Effective Date. Except as explicitly provided
in this Termination Agreement, all of the Parties’ respective
rights and obligations with respect to Licensed Product under the
License Agreement, if any, shall terminate; provided, that all of
the Parties’ rights and obligations under the License
Agreement with respect to any Additional Product(s) shall continue.
By way of clarification of the preceding sentence, on and after the
date hereof Section 13.03 of the License Agreement (including
Section 13.03(b) with respect to the Licensed Products) shall
survive and bear upon the termination of the License