Pfizer Territory. Pfizer, in its sole responsibility and discretion, shall be entitled to make all decisions with respect to any such Corrective Action with respect to any Licensed Product in the Pfizer Territory.
Pfizer Territory. Following Option Closing (if it occurs):
(i) if Pfizer wishes to perform any Clinical Trials or Other Studies for the Oncology Product in the Oncology Field in the Pfizer Territory which are not already set out in the then-current Development Component of the Pfizer Operation Plan, Pfizer shall submit detailed particulars of such proposed Clinical Trials or Other Studies for the Oncology JMDRC’s approval. Upon any approval by the Oncology JMDRC of such proposal, such proposal shall be deemed to be included as part of the Development Component of the Pfizer Operation Plan.
(ii) Following Option Closing (if it occurs), operational or tactical level decisions necessary to execute any medical affairs and Development activities in the Pfizer Territory shall be within the decision-making authority of Pfizer; provided that: (i) all such decisions shall be consistent with the terms of this Agreement and Applicable Law; and (ii) Pfizer shall periodically consult the Oncology JMDRC with respect to operationalizing such operational or tactical level decisions and shall reasonably take into account the Oncology JMDRC’s comments with respect thereto.
Pfizer Territory. (i) Following Option Closing (if any), the marketing authorization with respect to the Oncology Product(s) in the Oncology Field in any country or jurisdiction in the Pfizer Territory shall be transferred to or otherwise held by Pfizer, unless otherwise agreed between the Parties in writing. Upon the approval of such transfer to Pfizer by the relevant Regulatory Authority or any other date agreed by the Parties in writing, Myovant shall use [***] to transfer all Regulatory Materials (including Drug Approval Applications) and communications with the applicable Regulatory Authorities for the Pfizer Territory to Pfizer and Pfizer shall, following such transfer, be responsible for and shall have the sole right with respect to the Regulatory Activities with respect to such Oncology Product(s) in such country or jurisdiction in the Pfizer Territory. Pfizer shall fully co-operate with Myovant in order to facilitate such transfer of Regulatory Materials from Pfizer to Myovant, including executing any documents required for such transfer. Myovant shall be responsible for its costs of providing any reasonable assistance to Pfizer with respect to such transfer of marketing authorization to Pfizer, provided that, if Myovant is required to perform any regulatory activities or assistance beyond what is considered reasonable in connection with such transfer, the Parties shall agree in writing the cost to be reimbursed to Myovant for such activities or assistance prior to such costs being incurred by Myovant.
(ii) Following Option Closing (if it occurs), Pfizer shall use [***] to seek Regulatory Approvals for the Oncology Product in the Oncology Field in the applicable [***] as determined in accordance with Exhibit 1.144 in the Pfizer Territory.
Pfizer Territory. In respect of the Regulatory Activities for which the Regulatory Party is responsible in the Pfizer Territory, the Regulatory Party shall promptly provide to the other Party copies of all Major Regulatory Filings filed with any Regulatory Authority in the Pfizer Territory, in each case, relating to any Product in the Field. In addition, to the extent requested by [***], if Pfizer is the Regulatory Party with respect to the Pfizer Territory, Pfizer shall provide copies of proposed Regulatory Materials to be filed with any Regulatory Authority relating to any such Product sufficiently in advance of Pfizer’s filing or submission thereof, and shall reasonably consider all comments provided by [***] via Myovant to the extent required under the [***] Agreement.
Pfizer Territory. Subject to the terms and conditions of this Agreement, following Option Closing (if it occurs), Pfizer shall be solely responsible for Commercialization of the Oncology Product(s) in the Oncology Field and Pediatric Product(s) in the Pediatric Field in the Pfizer Territory in accordance with the Commercialization Component of the Pfizer Operation Plan.
Pfizer Territory. Following Option Closing (if it occurs), Pfizer shall: (i) use [***] to Commercialize the Oncology Product(s) in the Oncology Field in each of the Major Countries for which Regulatory Approval has been obtained and (ii) Pfizer shall evaluate whether Commercializing the Oncology Product in each country (other than the Major Countries) in the Pfizer Territory is commercially reasonable, and shall use [***] to Commercialize the Oncology Product(s) in each indication in the Oncology Field in each country in the Pfizer Territory for which Regulatory Approval has been obtained and where Commercialization of such Product has been deemed reasonable, and (ii) without limiting the foregoing, for the first [***] years following the Effective Date, perform the activities under the Pfizer Operation Plan. Pfizer shall bear all costs and expenses incurred in connection with Commercialization of the Oncology Product(s) in the Oncology Field in or for the Pfizer Territory.
Pfizer Territory. No later than [***] of each Calendar Year following Option Closing (if it occurs), Pfizer shall provide to the Oncology JCC (and the WH JCC if any Commercialization activities with respect to the Pediatric Product(s) were conducted in such Calendar Year) a detailed written report of the Commercialization activities that Pfizer, its Affiliates and Sublicensees have performed, or caused to be performed, since the preceding report, the future activities it expects to initiate in the Pfizer Territory. Each such report will contain sufficient detail to enable Myovant to assess Pfizer’s compliance with its obligations set forth in Section 5.3.1 and will include a rolling [***] year forecast of estimated Net Sales for the Oncology Product in the Pfizer Territory. Without limiting the foregoing, Pfizer shall provide to the Oncology JCC a revenue report and a revenue projection for the Oncology Product in the Pfizer Territory at the end of each Calendar Quarter after the First Commercial Sale of the Oncology Product in the Pfizer Territory.
Pfizer Territory. Following the Option Closing if it occurs, Pfizer shall be responsible for training its own Sales Force in the Pfizer Territory at its sole expense.
Pfizer Territory. Following the Option Closing if it occurs, this Section 6.3.2 shall apply. Pfizer shall be solely responsible for its Promotional and Educational Materials for use by Pfizer in the Pfizer Territory. Pfizer may develop the Promotional and Educational Materials for the Oncology Product(s) in the Oncology Field for use in the Pfizer Territory that are different than the ones used in the Co-Promotion Territory, provided that such Pfizer-developed Promotional and Educational Materials shall not have a substantial adverse effect on the Commercialization activities with respect to the Oncology Product(s) in the Co-Promotion Territory. All Promotional and Educational Materials shall comply with Applicable Law and be consistent with the applicable Product Labeling. Pfizer shall own all copyrights in and to the Promotional and Educational Materials developed for the Oncology Product(s) in the Pfizer Territory under this Agreement.
Pfizer Territory. Pfizer, without cause, for any or no reason, may terminate this Agreement on a Region by Region basis for all Oncology Products with respect solely to the rights granted to Pfizer under this Agreement for such Region by providing [***] days’ prior written notice of such termination to Myovant if there has been no First Commercial Sale of such Oncology Product by Pfizer, its Affiliates or Sublicensees in such Region, or [***] days’ prior written notice to Myovant following the First Commercial Sale of such Oncology Product by Pfizer, its Affiliates or Sublicensees in such Region. If Pfizer terminates this Agreement with respect to the United States or to a Region under this Section 15.4, such Region or the United States shall be deemed to be a “Terminated Territory” under this Agreement.
