Common use of Establishment; Responsibilities Clause in Contracts

Establishment; Responsibilities. Promptly after the Effective Date, the Parties agree to establish and convene a Joint Review Committee (or “JRC”) to provide a forum for discussing Licensee’s ongoing Development and Commercialization activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products pursuant to this Agreement and the coordination of such Licensee activities with Takeda’s Development and Commercialization of the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Takeda Territory (where applicable). The JRC will consist of representatives and operate by the procedures in accordance with this Section 2.2 (Joint Review Committee). Except as otherwise provided herein, the role of the JRC will be: (a) to coordinate the transfer of all Assigned Regulatory Materials to be assigned to Licensee pursuant to Section 4.3.1 (Licensed Product INDs) and Section 4.3.2 (Other Assigned Regulatory Materials); (b) to review, discuss, and solely with respect to any Development activities in the Takeda Territory set forth therein, approve, any proposed material amendments or revisions to the TAK-385 Development Plan; (c) to review and discuss the initial TAK-385 Commercialization Plan, and any proposed material amendments or revisions to such Commercialization Plan; (d) to review and discuss Licensee’s activities and progress under the TAK-385 Development Plan, including to review and discuss the Development reports described in Section 5.4 (Development Reporting); (e) to review and discuss Takeda’s activities and progress with respect to the Development of the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Men’s Health Field and the Women’s Health Field in the Takeda Territory; (f) to review and discuss Licensee’s activities and progress against the Commercialization Plan, including to review and discuss the Commercialization reports described in Section 7.4 (Commercialization Reporting); (g) to review and discuss Takeda’s activities in the Men’s Health Field and its progress against the Takeda Commercialization Plan with respect to activities in the Men’s Health Field, including to review and discuss the Commercialization reports described in Section 7.4 (Commercialization Reporting); (h) to discuss and coordinate Licensee’s Development activities with Takeda’s Development and Commercialization of the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Takeda Territory (where appropriate); (i) to discuss the selection of the Product Trademarks to be used by each Party in connection with the Commercialization of the TAK-385 Licensed Products, subject to Section 10.9 (Trademarks); and (j) subject to Section 2.2.2 (JRC Decisions), to attempt to resolve any matters in dispute arising between the Parties.