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SECOND AMENDMENT TO THE MASTER DEVELOPMENT
AND TOLL MANUFACTURING AGREEMENT BETWEEN
ENDO PHARMACEUTICALS INC. AND
NOVARTIS CONSUMER HEALTH, INC.
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 ***.
This Second
Amendment to the Master Development and Toll Manufacturing
Agreement, dated May 3, 2001 (as amended, the
“Agreement”), by and between Endo Pharmaceuticals Inc.
(“Endo”) and Novartis Consumer Health, Inc.
(“Novartis”) is entered in this 2
nd day of August 2005 and is effective as of
December 1, 2004 (this “Amendment”).
WHEREAS, Endo
and Novartis entered into the Agreement pursuant to which Novartis
agreed to perform certain Services on behalf of Endo as set forth
therein;
WHEREAS, Endo
and Novartis mutually amended the Agreement by way of a First
Amendment dated February 1, 2003; and
WHEREAS, Endo
and Novartis now desire to further amend the Agreement as more
fully set forth below;
NOW THEREFORE,
for good and valuable consideration, the receipt of which is hereby
acknowledged, the parties hereto agree as follows:
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1.
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Unless otherwise set forth herein,
the capitalized terms contained in this Amendment shall have the
meanings set forth in the Agreement.
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2.
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The
following Annexes to the Agreement are hereby deleted in their
entirety and replaced the following Annexes attached
hereto:
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3.
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The
definition of “Annex I” is hereby added to
Section 2:
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“Annex
I” means the *** attached to this Agreement as Annex I, as
may be amended or supplemented from time to time.
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4.
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The
definition of “Development Work” is hereby deleted in
its entirety and replaced with the following:
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“Development Work” means the
activities to be performed by Novartis which are related to product
development for NDA or ANDA products or required for the scale-up
and/or transfer of a product to Novartis from another
site.”
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5.
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The
definition of “Initial Term” is hereby deleted in its
entirety and replaced with the following:
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““Initial Term” means the
period of time commencing on the Effective Date and ending
December 31, 2006.”
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6.
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The
definition of “Production Baseline” is hereby deleted
in its entirety and replaced with the following:
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“Production Baseline” means *** of
Products (excluding ***), in any combination, during each
Production Year ***, or any equivalent thereof to be determined by
mutual agreement of the parties.”
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7.
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The
definition of “Production Year” is hereby deleted in
its entirety and replaced with the following:
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“Production Year” means each period
of twelve (12) consecutive months commencing on the FDA
Approval Date for the first Initial Product to be approved by the
FDA, or any anniversary thereof, during the Term, and following
January 1, 2005, means each period of twelve
(12) consecutive months thereafter.
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8.
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Section 2 of the Agreement is
hereby deleted in its entirety and replaced with the
following:
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“2.
DESCRIPTION OF DEVELOPMENT WORK
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2.1
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Novartis shall perform all
Development Work at the Facility or other site specified by Endo
and agreed to by Novartis.
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2.2
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Novartis shall determine the costs
for all Development Work to be done and invoiced to Endo;
provided that Endo must agree in writing to those costs
before such Development Work begins.
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2.3
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Endo and Novartis may choose to set
an annual fixed fee based on the amount of Development Work to be
done which fee
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