EISAI Responsibilities Clause Samples

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...