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THIRD AMENDMENT
TO THE AMENDED AND RESTATED
STRATEGIC ALLIANCE AGREEMENT
BY AND BETWEEN
PENWEST PHARMACEUTICALS CO.
AND
ENDO PHARMACEUTICALS INC.
This Third
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 and further amended by the Second Amendment
dated as of July 14, 2008 (the “Agreement”) is
entered into by and between Penwest Pharmaceuticals Co.
(“Penwest”) and Endo Pharmaceuticals Inc.
(“Endo”), effective as of January 1,
2009.
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 Pen
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