Co-Promotion Territory. United States of America and its possessions and territories, including Puerto Rico.
Co-Promotion Territory. With respect to the Co-Promotion Territory, the parties shall have the rights and obligations set forth in this Article IV.
Co-Promotion Territory. The Parties agree that Myovant shall be responsible for and shall have the sole right with respect to (i) the preparation, submission, and maintenance of all Regulatory Materials (including Drug Approval Applications), and (ii) conducting communications with the applicable Regulatory Authorities (together the “Regulatory Activities”), in each case, with respect to the Products in the United States. The Parties shall reasonably agree as to when Regulatory Activities with respect to Canada shall commence and which Party shall be responsible for Regulatory Activities for the Products in the Field in Canada and accordingly the Regulatory Party with respect to Canada.
Co-Promotion Territory. In respect of the Regulatory Activities for which the Regulatory Party is responsible in the Co-Promotion Territory, the Regulatory Party shall promptly provide to the applicable JMDRC all proposed material Regulatory Materials to be filed with or submitted to any Regulatory Authority, and copies and details of Regulatory Materials including final Product Labeling and specifications received by such Regulatory Party from the Regulatory Authorities in the Co-Promotion Territory, in each case, relating to any Product in the Field, for the Non-Regulatory Party’s review and comments (and, in the case of the Major Regulatory Filings, for JSC approval under Section 2.4.12 or JMC approval under Section 2.6.3 in relation to CMC portions thereof), sufficiently in advance of the Regulatory Party’s filing or submission thereof. The Regulatory Party shall reasonably consider all comments provided by such Non-Regulatory Party in connection with the Regulatory Materials with respect to the Co-Promotion Territory and shall respond within a reasonable time frame to all reasonable inquiries by such Non-Regulatory Party with respect thereto.
Co-Promotion Territory. Subject to the terms and conditions of this Agreement, each Party shall be responsible for the performance of the activities in relation to the Commercialization of the Products in the Field in the Co-Promotion Territory allocated to it under each Co-Promotion Commercialization Plan and Budget, in each case, in accordance with such Co-Promotion Commercialization Plan and Budget and subject to the oversight by the applicable JCC pursuant to Section 2.5. The Parties have agreed that [***]. The Parties shall cause their respective representatives on the applicable Committees to divide Detailing activities between the Parties so that Detailing efforts contributed by each Party are [***]. The JCC shall review the Detailing efforts contributed by each Party at least [***] per year and shall, as agreed to by the applicable Committee, make adjustments as necessary in an effort to maintain an equality of efforts contributed by each Party.
Co-Promotion Territory. Each Party shall use [***] to perform the Commercialization activities assigned to it in the applicable Co-Promotion Commercialization Plan and Budget. Without limiting the foregoing, each Party shall use [***] to Commercialize the Products in each indication in the Field in Co-Promotion Territory for which Regulatory Approval has been obtained.
Co-Promotion Territory. At least once every [***] during the period in which a Party is conducting Commercialization activities in the Co-Promotion Territory hereunder, such Party shall provide to the applicable JCC reasonably detailed written reports of the Commercialization activities it has performed, or caused to be performed (other than its Detailing activities in the Co-Promotion Territory, which are addressed in Section 6.1.4) in the Co-Promotion Territory, since the preceding report (or with respect to the first such report, since the Effective Date) and the future activities it expects to initiate during the then-current [***]. Each such report shall contain sufficient detail to enable the other Party to assess such Party’s compliance with its obligations set forth in Section 5.3.1, including the nature of Commercialization activities conducted.
Co-Promotion Territory. Promptly after the Effective Date, Myovant shall provide Pfizer with the training materials it uses for the Oncology Product in the Co-Promotion Territory and Pfizer shall train its own Sales Force for the Oncology Product in the Oncology Field using such training materials, as revised by Pfizer as appropriate at Pfizer’s sole discretion (subject to the subsequent sentence) promptly thereafter, at its cost and expense. Either Party may object to the training materials for the WH Product prepared by the other Party through the applicable Joint Review Committee, and Myovant may object to the training materials for the Oncology Product revised by Pfizer, [***]. Each Party shall have the right to train its own Sales Force and develop its own training materials for the WH Product in the WH Field, provided that such training materials are subject to review and approval by the applicable Joint Review Committee, and each Party shall schedule its initial training, at its cost and expense, for its Sales Representatives for the WH Product in the WH Field in sufficient time to ensure the applicable women’s health Sales Representatives are fully trained prior to the launch of the WH Product in the WH Field in the Co-Promotion Territory. If the Parties agree to jointly train their respective Sales Force, the applicable JCC shall (i) prepare a Product-specific training plan and update such plan as needed, and (ii) develop training materials to be approved through the applicable Joint Review Committee to be used by both Parties and update such training materials from time to time as appropriate. The Costs for the joint training activities shall be Sales and Marketing Costs but solely to the extent included in the applicable Co-Promotion Commercialization Plan and Budget; otherwise, each Party shall bear its own cost and expense in connection therewith. The applicable JCC-designated Party shall produce (or cause to be produced) sufficient quantities of the approved joint training materials for both Parties’ use in the Co-Promotion Territory, and the Costs of such training materials shall be included in Sales and Marketing Costs. The Parties will endeavor to use the joint training materials for consistency and efficiency.
Co-Promotion Territory. The applicable JCC may from time to time develop Promotional and Educational Materials that each Party may, but is not required to, use in promoting the Products in the Co-Promotion Territory (“Joint Promotional and Educational Materials”), which materials shall be reviewed and approved by the applicable Joint Review Committee prior to use. All Promotional and Educational Materials shall comply with Applicable Law and be consistent with the applicable Product Labeling. The applicable Joint Review Committee shall review and determine whether to reapprove the then-most recent Joint Promotional and Educational Materials on at least an annual basis, and either Party may propose amendments thereto during such annual review or at any other time. Myovant shall own all copyrights in and to the Joint Promotional and Educational Materials developed for the Co-Promotion Territory.
Co-Promotion Territory
