Territory Development Plan. Prior to ZLAB’s performance of any Development of the Product in the Territory (other than a Global Trial), the JSC must agree to a Territory Development Plan governing such Development and, for clarity, such Development shall be limited to the Approved Product for an Approved Indication that is specific to the Territory. If ZLAB desires to conduct any such Development during the Term, it shall submit to Regeneron, through the JDC, for review and revision, if applicable, a proposed Territory Development Plan including all of the detail set forth in the last sentence of this Section 5.2, and the JDC shall submit such updated Territory Development Plan to the JSC for approval. ZLAB will review and update the Territory Development Plan at least once annually and will present an updated Territory Development Plan to the JDC for review and revision, if applicable, at least […***…] prior to the end of each Calendar Year (starting in 2020), and the JDC shall submit the Territory Development Plan to the JSC for approval. The Parties will use good faith efforts to cause any updates to the Territory Development Plan to be approved by the JSC at least […***…] prior to the end of each Calendar Year. Each Territory Development Plan will set forth, in a reasonable level of detail, the plan for ZLAB’s Development of the Approved Product for the Approved Indications that is […***…] and will include all details set forth on Schedule 5.2, as well as strategies and timelines for Developing and obtaining and maintaining Regulatory Approvals for the Approved Product for the Approved Indications in the Territory.
Territory Development Plan. Except for the activities allocated to Zai under the Global Development Plan pursuant to Section 5.3, all Development by Zai of Licensed Products in the Territory under this Agreement shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.2 and Section 3.2, the “Territory Development Plan”). Following the Effective Date, and at least [***] prior to Zai’s planned initiation of Development activities in the Territory, Zai shall provide to Five Prime an initial draft of the Territory Development Plan for Five Prime’s review and comment, which Territory Development Plan shall contain in reasonable detail all major Development activities (including all Clinical Trials) and the timelines for achieving such activities. Zai shall take such comments into consideration in good faith and incorporate such comments where appropriate prior to finalizing the initial Territory Development Plan. From time to time thereafter, but at least every [***], Zai shall propose amendments to the Territory Development Plan in consultation with Five Prime and submit such proposed updated or amended Territory Development Plan to the JSC for review, discussion and approval. Once approved by the JSC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto must be consistent with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.
Territory Development Plan. Except for the activities to be conducted by Zymeworks pursuant to Sections 5.1(b) and 5.2, as between the Parties, all Development of Licensed Products in the Territory shall be conducted by Jazz. Promptly after Jazz prepares[***] a written plan for its Development of Licensed Products in the Territory and, if applicable, outside the Territory (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”), Jazz shall provide Zymeworks with a copy of such plan. From time to time thereafter[***] Jazz shall propose amendments to the Territory Development Plan in consultation with Zymeworks and submit such proposed updated or amended Territory Development Plan to the JSC for review and discussion. Once reviewed by the JSC, the amended Territory Development Plan shall become effective. The Territory Development Plan must include, without limitation, [***].
Territory Development Plan. Subject to the remainder of this Section 4.1, all of Licensee’s development of Products will be conducted consistent with the Territory Development Plan, as such Territory Development Plan may be amended from time to time by Licensee pursuant to and in accordance with Section 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. Licensee shall be solely responsible for conducting, [***] such Territory-Specific development activities with respect to the Products in the Field in the Territory to support MAA filing and Regulatory Approval in the Territory, as set forth in the Territory Development Plan and the performance of its obligations under the Global Development Plan, as applicable. Licensee shall provide the 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 XXXx 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 not perform any activ...
Territory Development Plan. Without limiting the generality of the other provisions in this Article 4, an initial, mutually agreed Territory Development Plan is attached hereto as Exhibit D (the “Initial Development Plan”). Within [***] after the Effective Date, Kaken (in conjunction with assistance from Spruce) will prepare and submit to the JSC a high level plan concerning the Development of the Licensed Compound and Licensed Products in the Field in the Kaken Territory (the “First Supplemental Development Plan,” and together with the Initial Development Plan and any subsequent updates pursuant to this Section 4.2, the “Territory Development Plan”). The First Supplemental Development Plan shall include among other things, all material non-clinical studies, Phase 1 Clinical Trial, CMC Activities and regulatory activities with respect to the Licensed Compound and Licensed Products to be conducted by or on behalf of Kaken or its Affiliates or their respective Sublicensees in the Kaken Territory and include target timelines for: [***]. From time to time during the Term (but at least [***] per Kaken Fiscal Year), Kaken shall prepare amendments and updates, as appropriate, to the then-current Territory Development Plan, and shall submit such amendments and updates to the JSC in accordance with Section 4.3. For clarity, if there are no amendments or updates to the then-current Territory Development Plan that are applicable in a Kaken Fiscal Year, Kaken’s sole responsibility under this Section 4.2 during such Kaken Fiscal Year shall be to inform Spruce that the then-current Territory Development Plan is up to date.
Territory Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.2, all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written development plan (as amended from time to time in accordance with this Section 5.3 and Section 3.2, the “Territory Development Plan”). The initial Territory Development Plan is attached hereto as Exhibit 5.3. […***…].45
Territory Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.3, all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written development plan (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”). BeiGene shall provide the first Territory Development Plan for JDC review and discussion [***] after exercise of the Option by BeiGene. From time to time after the Effective Date, but not [***], BeiGene shall propose amendments to the Territory Development Plan in consultation with Leap and submit such proposed updated or amended Territory Development Plan to the JDC for review and discussion. For clarity, the Territory Development Plan and amendments thereto shall be consistent with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.39 34 Competitive Information – Discovery Information and Commercially Sensitive Terms. 35 Competitive Information – Discovery Information and Commercially Sensitive Terms. 36 Competitive Information – Discovery Information and Commercially Sensitive Terms. 37 Competitive Information – Discovery Information and Commercially Sensitive Terms. 38 Competitive Information – Discovery Information and Commercially Sensitive Terms.
Territory Development Plan. Except for the activities allocated to Zai under the Global Development Plan pursuant to Section 5.3, all Development by Zai of Licensed Products in the Territory under this Agreement shall be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.4 and Section 3.2, the “Territory Development Plan”), which Territory Development Plan shall contain in reasonable detail all major Development activities (including all Clinical Trials) for Licensed Products in the Territory and the timelines for achieving such activities. Attached hereto as Exhibit C is an initial draft of the Territory Development Plan and attached hereto as Exhibit B is a NMPA Submission Timeline for the indications of recurrent and newly diagnosed GBM. From time to time as needed thereafter, Zai shall propose amendments to the Territory Development Plan in consultation with NVCR and submit such proposed updated or amended Territory Development Plan to the JSC for review, discussion and approval. Once approved by the JSC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto must be consistent with the Global Development Plan and the Global Development Plan shall take precedent in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.
Territory Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.2, all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written development plan (as amended from time to time in accordance with this Section 5.3 and Section 3.2, the “Territory Development Plan”). The initial Territory Development Plan is 43 Competitive Information – Commercially Sensitive Terms. 44 Competitive Information – Discovery Information and Commercially Sensitive Terms. 45 Competitive Information – Discovery Information and Commercially Sensitive Terms. 46 Competitive Information – Discovery Information and Commercially Sensitive Terms. attached hereto as Exhibit 5.3. […***…].47
Territory Development Plan. Except for the activities allocated to BeiGene under the Global Development Plan pursuant to Section 5.2, all Development of Licensed Products in the Territory under this Agreement shall be conducted by BeiGene pursuant to a written development plan (as amended from time to time in accordance with this Section 5.3 and Section 3.3(a), the “Territory Development Plan” and, until the Territory Development Plan is approved pursuant to this Section 5.3(a), all references in this Agreement to the Territory Development Plan shall be deemed references to the ABI-H0731 Initial Development Plan). The Territory Development Plan shall include a proposed budget for the Development activities (including the Territory Clinical Trials) set forth under the Territory Development Plan (including any Costs incurred related to any start-up activities for any Phase 3 Clinical Trial) (the “Territory Development Budget”). AssemblyBio will propose the initial draft of the Territory Development Plan for the Licensed ABI-H2158 Products and Licensed ABI-H3733 Products and submit to the JDC for its review, discussion and approval. From time to time after the Effective Date, but not less than annually, either Party may propose amendments to the Territory Development Plan and submit such proposed updated or amended Territory Development Plan to the JDC for review, discussion and approval. Once approved by the JDC, the amended Territory Development Plan shall become effective. For clarity, the Territory Development Plan and amendments thereto shall be consistent with the Global Development Plan, and the Global Development Plan shall take precedence in case of any conflict or inconsistency between the Territory Development Plan and the Global Development Plan.
