Exhibit 10.18.2
SECOND AMENDMENT
TO THE AMENDED AND RESTATED
STRATEGIC ALLIANCE AGREEMENT
BY AND BETWEEN
PENWEST PHARMACEUTICALS CO.
AND
ENDO PHARMACEUTICALS INC.
This Second Amendment (this
“Amendment”) to the Amended and Restated Strategic
Alliance Agreement dated as of April 2, 2002, and as amended
by the Amendment Agreement dated January 7, 2007 (the
“Agreement”) is entered into by and between Penwest
Pharmaceuticals Co. (“Penwest”) and Endo
Pharmaceuticals Inc. (“Endo”), effective as of
July 14, 2008.
Endo and Penwest agree as
follows:
1. Section 1.23 of the
Definitions Exhibit to the Agreement is amended by deleting
Section 1.23 in its entirety and inserting the following new
Section 1.23 in its place:
1.23 “Formulated TIMERx
Price” shall mean Penwest’s contract manufacturing cost
(or, if made internally, its variable costs plus directly allocable
(a) fixed and (b) manufacturing overhead costs relating
to the manufacture or acquisition) of the Formulated TIMERx to be
provided to Endo or its Affiliates or sublicensees hereunder, as
shall be determined and adjusted no more often than annually
plus the costs directly relating to the quality control
testing referred to in Section 7.2 hereof plus the
allocable indirect costs and fees referred to in the last two
sentences of this Section 1.23; provided, however ,
that any amounts paid or payable by Penwest for third-party
royalties (or for materials acquisition costs to the extent
attributable to third-party intellectual properties and essentially
equivalent to royalties) which are the responsibility of Penwest
under Sections 9.5.1 or 9.5.2 hereof shall not be counted as part
of the Formulated TIMERx Price. Costs and fees related to and
arising out of patent enforcement litigation ensuing from a third
party certifying against a Penwest Patent or a patent covering
Penwest Product Technology held by Penwest and listed in the
FDA’s “Orange Book” may (to the extent not
reflected in the Certification Budget and the reconciliations under
Section 3.7 hereof) be included, at the option of Penwest and
without prejudice to its other rights, as part of the allocable
indirect costs of the manufacture or acquisit
