Common use of EISAI Responsibilities Clause in Contracts

EISAI Responsibilities. i) EISAI shall undertake the responsibilities allocated to EISAI (A) in the Joint Development Plan under the direction and oversight of the JDC and (B) in the Joint Commercialization Plan under the direction and oversight of the JMC; ii) Unless otherwise mutually agreed by the Parties, subject to JDC oversight, (A) EISAI shall be responsible, in consultation with EPIZYME, for preparing and submitting regulatory applications to Regulatory Authorities in order to obtain the Regulatory Approvals with respect to the Shared Product, and EISAI shall own and maintain all Regulatory Approvals, and (B) EISAI shall be responsible, in consultation with EPIZYME, for communicating and meeting with Regulatory Authorities with respect to the Shared Product, provided that (x) EISAI shall share with EPIZYME material written communications it receives from Regulatory Authorities and (y) if EPIZYME so requests, and to the extent permitted by applicable Law, one (1) representative of EPIZYME shall have the right to be present in any such communications and meetings with Regulatory Authorities; iii) EISAI shall use (A) an appropriate management infrastructure to supervise the Commercialization Personnel employed by EISAI and required to oversee performance of EISAI’s Commercialization obligations under the Joint Commercialization Plan, including performance of its Detail Requirements, and (B) Commercialization Personnel of sufficient number and adequate experience to implement its responsibilities under the Joint Commercialization Plan; iv) EISAI shall have the sole right and responsibility to (A) subject to the WAC pricing strategy adopted by the Parties in the Joint Commercialization Plan, determine the price and other terms of sale for the Shared Product (including discounts, rebates, and the like) and (B) record and collect payment for sales of the Shared Product throughout the U.S. EISAI shall be responsible for distribution, invoicing and collection with respect to sales of the Shared Product in the U.S. and shall book such sales (it being understood that EISAI shall be solely and exclusively responsible for its own revenue recognition with respect to the Shared Product, and EPIZYME shall have no responsibility therefor); v) EISAI shall use Commercially Reasonable Efforts to build and maintain an appropriate pharmacovigilance infrastructure, including to maintain a global safety database with respect to the Shared Product, in connection with which the Parties shall enter into a pharmacovigilance agreement; vi) EISAI shall have the sole right to Manufacture the Shared Product or contract a Third Party to Manufacture the Shared Product, in either case, in a commercially reasonable manner, including managing raw material supply for Manufacturing the Shared Product, warehousing and distributing the Shared Product; vii) EISAI will update the JMC on a [**] basis with respect to material Manufacturing matters for the Shared Product; and viii) The Parties shall mutually agree upon the trademarks and logos to be used in connection with the Shared Product in the United States (the “Product Trademarks”), consistent with the branding strategy implemented by EISAI with respect to such Shared Product in the ROW. Except as otherwise set forth in Section 13.5.1(h) or Section 13.5.2(a) of the CLA, EISAI shall have the sole right to register, maintain, enforce and defend the Product Trademarks (excluding any EPIZYME company-specific names or company-specific logos) for the Shared Product and own such Product Trademarks (excluding any EPIZYME company-specific names or company-specific logos), including all associated goodwill. For purposes of clarity, EPIZYME shall retain ownership of all right, title and interest in and to any EPIZYME company-specific names or company-specific logos, including all associated goodwill.