Joint Manufacturing Committee. Within [***] after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (or “JMC”) as a subcommittee of the JSC. The JMC shall have an initial term of [***] and shall [***] for successive [***]. The JMC shall have only the powers assigned expressly to it in this Section 3.13 and elsewhere in this Agreement, and the JMC shall not have any power to amend, modify or waive compliance with this Agreement. The JMC shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful Manufacture, Development and Commercialization of Licensed Products. The role of the JMC shall be to: (a) oversee the conduct of the Manufacturing of the Licensed Product by or on behalf of SGI and MPI under this Agreement, the Non-Commercial Supply Agreement and the Commercial Supply Agreement; (b) develop, update and annually approve a global plan for Manufacturing the Licensed Product, which plan shall include the strategy for the Manufacturing of the Licensed Product on a worldwide basis, and may include certain shared global Manufacturing activities (i.e., activities that benefit the Licensed Product in both the SGI Territory and the Licensed Territory, including such activities that relate to further process development, quality control release testing and quality assurance disposition, and inventory management, and, subject to mutual written agreement of the Parties, the appropriate allocation of responsibilities and, if applicable, [***]); (c) facilitate the sharing of information between the Parties as necessary to support the Manufacturing of the Licensed Product; (d) oversee the implementation of the global plans for the Manufacturing of the Licensed Product and the introduction of second sourcing and/or Manufacturing process improvements for the Licensed Product; and (e) perform such other functions as appropriate to further the purposes of this Agreement, as mutually determined by the Parties.
Appears in 2 contracts
Samples: Collaboration Agreement (Takeda Pharmaceutical Co LTD), Collaboration Agreement (Seattle Genetics Inc /Wa)
Joint Manufacturing Committee. Within [***] after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (or “JMC”) as a subcommittee of the JSC. The JMC shall have an initial term of [***] and shall [***] for successive [***]. The JMC shall have only the powers assigned expressly to it in this Section 3.13 and elsewhere in this Agreement, and the JMC shall not have any power to amend, modify or waive compliance with this Agreement. The JMC shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful Manufacture, Development and Commercialization of Licensed Products. The role of the JMC shall be to:
(a) oversee the conduct of the Manufacturing of the Licensed Product by or on behalf of SGI and MPI under this Agreement, the Non-Commercial Supply Agreement and the Commercial Supply Agreement;; [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) develop, update and annually approve a global plan for Manufacturing the Licensed Product, which plan shall include the strategy for the Manufacturing of the Licensed Product on a worldwide basis, and may include certain shared global Manufacturing activities (i.e., activities that benefit the Licensed Product in both the SGI Territory and the Licensed Territory, including such activities that relate to further process development, quality control release testing and quality assurance disposition, and inventory management, and, subject to mutual written agreement of the Parties, the appropriate allocation of responsibilities and, if applicable, [***]);
(c) facilitate the sharing of information between the Parties as necessary to support the Manufacturing of the Licensed Product;
(d) oversee the implementation of the global plans for the Manufacturing of the Licensed Product and the introduction of second sourcing and/or Manufacturing process improvements for the Licensed Product; and
(e) perform such other functions as appropriate to further the purposes of this Agreement, as mutually determined by the Parties.
Appears in 1 contract
Joint Manufacturing Committee. Within [***] after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (or “JMC”) as a subcommittee of the JSC. The JMC shall have an initial term [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. of [***] and shall [***] for successive [***]. The JMC shall have only the powers assigned expressly to it in this Section 3.13 and elsewhere in this Agreement, and the JMC shall not have any power to amend, modify or waive compliance with this Agreement. The JMC shall conduct its discussions in good faith with a view to operating to the mutual benefit of the Parties and in furtherance of the successful Manufacture, Development and Commercialization of Licensed Products. The role of the JMC shall be to:
(a) oversee the conduct of the Manufacturing of the Licensed Product by or on behalf of SGI and MPI under this Agreement, the Non-Commercial Supply Agreement and the Commercial Supply Agreement;
(b) develop, update and annually approve a global plan for Manufacturing the Licensed Product, which plan shall include the strategy for the Manufacturing of the Licensed Product on a worldwide basis, and may include certain shared global Manufacturing activities (i.e., activities that benefit the Licensed Product in both the SGI Territory and the Licensed Territory, including such activities that relate to further process development, quality control release testing and quality assurance disposition, and inventory management, and, subject to mutual written agreement of the Parties, the appropriate allocation of responsibilities and, if applicable, [***]);
(c) facilitate the sharing of information between the Parties as necessary to support the Manufacturing of the Licensed Product;
(d) oversee the implementation of the global plans for the Manufacturing of the Licensed Product and the introduction of second sourcing and/or Manufacturing process improvements for the Licensed Product; and
(e) perform such other functions as appropriate to further the purposes of this Agreement, as mutually determined by the Parties.
Appears in 1 contract
Samples: Collaboration Agreement (Takeda Pharmaceutical Co LTD)