Common use of Establishment; Responsibilities Clause in Contracts

Establishment; Responsibilities. The Parties have established, under the License Agreement, a joint manufacturing working group (the “Joint Manufacturing Working Group” or “JMWG”), which shall have, with respect to this Agreement, the responsibilities set forth in this Section 2.3. For clarity, Section 4.1 of the License Agreement and the “Transition Plan” described therein shall remain in full force and effect for Licensed Compounds including the Drug Substance under this Agreement; provided, however, that the disclaimers set forth in Section 4.2.2 (Takeda Materials Disclaimer) of the License Agreement will not negate any express warranties made by Takeda in this Agreement. The JMWG shall be responsible for overseeing, reviewing and coordinating activities related to the supply of Drug Substance under this Agreement and operational decisions with respect thereto, including as follows: (a) The implementation of activities under the Drug Substance Transition Plan (as defined below); (b) The creation of the Gain-sharing Report and implementation of changes described therein, as set forth in Section 7.3 (Continuous Improvement) hereof. For clarity, the JMWG shall have no authority to amend or waive compliance with any provision of this Agreement.