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