Common use of Territory Development Plan Clause in Contracts

Territory Development Plan. Except for the activities assigned to Partner under a Global Development Plan for a Licensed Product pursuant to Section 5.3 (Global Development Plan) all Development by or on behalf of Partner of Licensed Products and any Companion Diagnostic to be used in connection therewith designed to generate data that is intended to be used for the purposes of obtaining Regulatory Approval in the Territory will be conducted pursuant to a written development plan agreed by the JDC and approved by the JSC (as updated from time to time in accordance with this Section 5.2 (Territory Development Plan) and Section 3.2 (Joint Steering Committee), the “Territory Development Plan”), and Partner will be primarily responsible for all Territory Development activities for the Licensed Products. An outline of the initial Territory Development Plan for the Licensed Products is set forth on Schedule 5.2 (Territory Development Plan) attached hereto. The Territory Development Plan and all updates thereto will contain [***] (a) all major Territory Development activities for the Licensed Products (including all non-clinical and preclinical studies and Territory-Specific Clinical Trials and the trial design thereof) to be conducted solely in furtherance of obtaining and maintaining Regulatory Approval of the Licensed Products in each Indication in the Territory and any Territory Development activities to be conducted for a Licensed Product solely for use in the Territory, (b) the estimated timelines for performing and completing such activities, including Development of Companion Diagnostics for Licensed Products that are to be used with one or more Licensed Products, and (c) an outline of the ​ ​ key elements involved in obtaining Regulatory Approval of such Licensed Product in each Indication from all applicable Regulatory Authorities throughout the Territory as further described in Section 6.1 (Regulatory Strategy), including the estimated timelines for Regulatory Submissions for the Licensed Products in each country or region in the Territory. In addition, [***], the JDC will propose updates to each Territory Development Plan and submit such proposed updated Territory Development Plan to the JSC. The JSC will review, discuss, and determine whether to approve any and all such updates to the Territory Development Plan. Once approved by the JSC, each update to the Territory Development Plan will become effective and supersede the then-current Territory Development Plan. Notwithstanding any provision to the contrary set forth in this Agreement, including Partner’s final decision-making authority under Section 3.8.2(b) (Partner Final Decision-Making Authority), the Territory Development Plan and all updates thereto must be consistent with the Global Development Plan for such Licensed Product except as provided in Section 5.4 (New Development by Partner). In the event of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan, the Global Development Plan will control and take precedence.

Territory Development Plan. Except for Subject to the activities assigned to Partner under a Global Development Plan for a Licensed Product pursuant to remainder of this Section 5.3 (Global Development Plan) 4.1, all Development by or on behalf of Partner Licensee’s development of Licensed Products and any Companion Diagnostic to be used in connection therewith designed to generate data that is intended to be used for the purposes of obtaining Regulatory Approval in the Territory will be conducted pursuant to a written development plan agreed by consistent with the JDC and approved by the JSC (Territory Development Plan, as updated such Territory Development Plan may be amended from time to time by Licensee pursuant to and in accordance with this Section 5.2 (Territory 4.1(b), except for those activities for which Licensee has agreed to conduct in support of any Global Phase 2/3 Study, as contemplated in Section 4.2(b), which shall be set forth in the Global Development Plan) and Section 3.2 (Joint Steering Committee), the “Territory Development Plan”), and Partner will . Licensee shall be primarily solely responsible for all Territory Development activities for the Licensed Products. An outline of the initial Territory Development Plan for the Licensed Products is set forth on Schedule 5.2 (Territory Development Plan) attached hereto. The Territory Development Plan and all updates thereto will contain conducting, [***] (a) all major Territory Development activities for the Licensed Products (including all non-clinical and preclinical studies and such Territory-Specific Clinical Trials and development activities with respect to the trial design thereof) to be conducted solely in furtherance of obtaining and maintaining Regulatory Approval of the Licensed Products in each Indication the Field in the Territory to support MAA filing and any Territory Development activities to be conducted for a Licensed Product solely for use Regulatory Approval in the Territory, (b) the estimated timelines for performing and completing such activities, including Development of Companion Diagnostics for Licensed Products that are to be used with one or more Licensed Products, and (c) an outline of the ​ ​ key elements involved in obtaining Regulatory Approval of such Licensed Product in each Indication from all applicable Regulatory Authorities throughout the Territory as further described in Section 6.1 (Regulatory Strategy), including the estimated timelines for Regulatory Submissions for the Licensed Products in each country or region in the Territory. In addition, [***], the JDC will propose updates to each Territory Development Plan and submit such proposed updated Territory Development Plan to the JSC. The JSC will review, discuss, and determine whether to approve any and all such updates to the Territory Development Plan. Once approved by the JSC, each update to the Territory Development Plan will become effective and supersede the then-current Territory Development Plan. Notwithstanding any provision to the contrary set forth in this Agreement, including Partner’s final decision-making authority under Section 3.8.2(b) (Partner Final Decision-Making Authority), the Territory Development Plan and all updates thereto must be consistent with the Global Development Plan for such Licensed Product except as provided in Section 5.4 (New Development by Partner). In the event of any conflict or inconsistency between the Territory Development Plan and the performance of its obligations under the Global Development Plan, as applicable. Licensee shall provide the Global initial Territory Development Plan to Dermavant reasonably in advance of the first meeting of the JDC, which initial Territory Development Plan shall be consistent in all material respects with the high level outline set forth on Exhibit C. Without limiting the foregoing, the Territory Development Plan shall include (i) an outline of all major development activities for Products for each indication within the Field in the Territory to be conducted by or on behalf of Licensee, its Affiliates or its or their Sublicensees, including clinical/non-clinical development activities necessary for obtaining and maintaining the ▇▇▇▇ for the Products in the Field in the Territory including, but not limited to, Phase 3 Trials in the Field in the Territory; (ii) estimated timelines for the conduct of such major development activities, as well as estimated timelines for submission of MAA applications for the Products in each indication the Field in the Territory; and (iii) estimated timelines of any other major development activities in the Territory, and (iv) any investigator-initiated clinical studies of a Product for which Licensee has the right to participate, as set forth in Section 3.1(b)(ix). As between the parties, but subject to the terms and conditions of this Agreement, Licensee shall be solely responsible, [***] for the performance of its activities under the Territory Development Plan, and Licensee shall keep Dermavant reasonably informed of the status, progress and results of all material developments with respect to the Territory Development Plan activities. Licensee will control not perform any activity that Dermavant reasonably believes in good faith and take precedence.following consultation with Licensee could adversely affect the development or commercialization of the Product outside the Territory. Upon Licensee’s reasonable request, Dermavant shall provide reasonable cooperation and informal assistance to Licensee in connection with the Territory Development Plan, [***] except to the extent otherwise agreed by the parties with respect to certain activities that are specific to the development or commercialization of the Product outside of the Territory or that falls within Dermavant’s responsibility as described in Section 4.2(a). Notwithstanding Section 2.9, if Dermavant includes, in an MAA application submitted to a Regulatory Authority in the Dermavant Territory to obtain Regulatory Approval for a Product in an Existing Formulation in a dosage strength other than [***] for the treatment of Atopic Dermatitis or Plaque Psoriasis, utilizes Information (other than safety data) which is generated by Licensee, its Affiliates or Sublicensees in the course of any Territory-specific development activities with respect to the efficacy of such Product in such formulation and dosage strength in such indication in the Field on the Territory, then Dermavant shall reimburse to Licensee [***] costs and expenses incurred by Licensee to generate such Information during such Territory-specific development activities within [***] following Dermavant’s receipt of