Formation; Purpose. Within thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be: i. to review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of the Products and the Modified Products in the Field in the Advaccine Territory, including related regulatory activities; ii. to review, discuss and approve the Initial Development Plan and any proposed amendments or revisions to the Development Plan, including the First Supplemental Development Plan and those with respect to clinical Development activities set forth in Section 4.4(b); iii. to review and discuss (but not approve) the Commercialization Plan and any proposed amendments or revisions to such plan, and review and discuss (but not approve) the Commercialization of the Products in the Field in the Advaccine Territory (including any pricing strategy with respect to the Products); iv. to coordinate the Commercialization of the Products in the Advaccine Territory and Inovio Territory to ensure consistent global marketing of the Products in the Field; and v. to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
Appears in 1 contract
Sources: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)
Formation; Purpose. Within thirty (30) days after the Effective Date, the The Parties shall establish have established a joint steering committee under the Prior Agreement (the “Joint Steering Committee” or “JSC”) which JSC shall be responsible for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be:
i. (i) to review, discuss and coordinate the overall strategy for the Development, Manufacturing, and Commercialization of the Products and the Modified Products in the Field in the Advaccine Territory, including related regulatory activities;
(ii. ) to review, discuss and approve the Initial Development Plan and any proposed amendments or revisions to the Development Plan, including the First Supplemental Development Plan and those with respect to clinical Development activities set forth in Section 4.4(b);
(iii. ) to review and discuss (but not approve) the Commercialization Plan and any proposed amendments or revisions to such plan, and review and discuss (but not approve) the Commercialization of the Products in the Field in the Advaccine Territory (including any pricing strategy with respect to the Products);
(iv. ) to coordinate the Commercialization of the Products in the Advaccine Territory and Inovio Territory to ensure consistent global marketing of the Products in the Field;
(v) to review, discuss and approve the Global Phase 3 Study Plan and any proposed amendments or revisions thereto; and
v. (vi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
Appears in 1 contract
Sources: Collaboration and License Agreement (Inovio Pharmaceuticals, Inc.)