Exhibit 10.25
AMENDMENT TO PRODUCT DEVELOPMENT
AND LICENSE AGREEMENT
This Amendment to the Product Development and
License Agreement, effective as of February 24, 2009, is by and
between Shire LLC, Shire Biopharmaceuticals Holdings (formerly
known as Shire plc) (collectively “Shire”) and Duramed
Pharmaceuticals, Inc. (“Duramed”). Shire and Duramed
are referred to together as the “Parties”.
WHEREAS, Shire and Duramed entered into the
Product Development and License Agreement (the
“Agreement”) dated as of August 14, 2006, pursuant to
which the Parties have cooperated on continued research and
development of certain pharmaceutical products, with the results of
such cooperation to be commercialized by Shire in the Shire
Territory and by Duramed in the Duramed Territory;
WHEREAS, Shire has determined that, despite the
Parties’ diligence, commercialization of the Collaboration
Products by Shire in the Shire Territory is unlikely and,
therefore, continued cooperation by the Parties on research and
development will not be productive for the Parties;
WHEREAS, pursuant to Section 17.1 of the
Agreement, the Parties desire to amend the Agreement in the manner
set forth herein;
NOW, THEREFORE, in consideration of the mutual
promises and covenants contained herein, the Parties agree to amend
the Agreement as follows:
1.
Capitalized Terms . Capitalized terms used and not defined
in this Amendment shall have the meanings ascribed to them in the
Agreement.
2.
Rights to Collaboration Products . The Parties agree that,
effective as of the execution date of this Amendment, any and all
rights and interests of Shire in the Collaboration Products are
returned to Duramed.
3.
Acknowledgement of Previously Reimbursed Development
Expenses . Shire acknowledges and agrees that the
$39,376,991 in Development Expenses previously invoiced
by Duramed and paid by Shire qualified for expense reimbursement
under the Agreement, and Shire waives any audit rights with respect
to such payments.
4.
Payment of Outstanding Invoice . Shire will pay the
outstanding January 26, 2009 invoice for Development Expenses
incurred in 2008 in the amount of $5,058,380 within three (3)
business days of the execution of this Amendment, by wire transfer
to an account designated by Duramed, and Shire waives any audit
rights with respect to such payment.
5.
Reimbursement for Development Expenses . Pursuant to Section
7.2.1 of the Agreement, Shire will reimburse Duramed for
Development Expenses incurred by Duramed between January 1, 2009
and December 31, 2009 and/or Carryover Expenses incurred by Duramed
prior to January 1, 2009, up to an aggregate amount of Thirty
Million Dollars ($30,000,000). Shire acknow
