Common use of Development Plans Clause in Contracts

Development Plans. During the Term, Licensee will conduct all Development activities in connection with the TAK-385 Licensed Compound or any TAK-385 Licensed Product in accordance with the terms and conditions set forth in this Article 5 (Development) and the plan for Development activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products (as such plan may be amended from time to time pursuant to this Section 5.3 (Development Plans) (with respect to the TAK-385 Development Plan), a “TAK-385 Development Plan”). [***]. The TAK-385 Development Plan will include reasonably detailed descriptions of: (a) all material Development activities reasonably anticipated to be undertaken by Licensee to obtain Regulatory Approval of the one or more TAK-385 Licensed Products in the Field in the Licensee Territory and in the Men’s Health Field in the Takeda Territory, (b) all Licensee Development Activities in the Takeda Territory, (c) all Initial Development Activities, (d) estimated dates on which Licensee expects to achieve each Development Milestone Event, including the filing of an NDA in each country in the Licensee Territory in which Licensee is Developing a TAK-385 Licensed Product, and (e) an estimate of costs and expenses associated with the activities set forth in the TAK-385 Development Plan. The initial TAK-385 Development Plan is attached hereto as Schedule 5.3 (TAK-385 Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (i) [***]; and (ii) [***], in each case consistent with the activities described in the initial TAK-385 Development Plan attached hereto as Schedule 5.3 (TAK-385 Development Plan). Licensee will prepare an update to the TAK-385 Development Plan at least annually. Licensee may amend the TAK-385 Development Plan as reasonable or necessary at any time during the Term; provided that all annual updates and any material amendments must be reviewed, discussed, and, solely with respect to any Development activities in the Takeda Territory, approved, by the JRC in accordance with Section 2.2.2(a) (Establishment; Responsibilities), and provided, further, that all such updates or material amendments to the TAK-385 Development Plan must be in accordance with the requirements of this Article 5 (Development). No update or amendment to the TAK-385 Development Plan related to Development activities in the Takeda Territory will be effective unless approved by the JRC in accordance with Article 2 (Governance). Licensee will provide Takeda with a copy of all updates or amendments to the TAK-385 Development Plan.

Development Plans. During For the TermFirst Licensed Compound, Licensee will conduct all the initial Development activities in connection with the TAK-385 Licensed Compound or any TAK-385 Licensed Product in accordance with the terms Plans through and conditions set forth in this Article 5 (Development) and the plan for Development activities including one Phase 2a Clinical Trial with respect to the TAK-385 Licensed Compound thereto are attached hereto as Exhibit C and TAK-385 Licensed Products Exhibit D (as such plan may be amended from time to time pursuant to this Section 5.3 (upon mutual agreement of the Parties, the “Development Plans) (,” including the “Development Plan — Pre-IND” and “Development Plan — Phase 1 and Phase 2a,” respectively). The Parties agree and acknowledge that these initial Development Plans reflect, as of the Execution Date, SYNTA’s good faith estimates of Development activities and the timing, internal costs, and external costs associated with such activities, all of which may be subject to change. With respect to the TAK-385 further Development Plan)of the relevant First Licensed Compound or following the approval for advancement into Development of any subsequent Licensed Compound, a “TAK-385 SYNTA and ROCHE, under the guidance of the JRDC, shall prepare initial or updated Development Plan”)Plans directed to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Development activities in the Territory for such Licensed Compound for the next twelve (12) month period. An updated Development Plan for each subsequent twelve (12) month period will be prepared by SYNTA and ROCHE at least [***] ([***]) days prior to the beginning of each such subsequent twelve (12) month period. The TAK-385 Development Plan will include reasonably detailed descriptions of: shall be consistent with the terms and conditions of this Agreement, and shall be subject to review and approval by the JRDC and the JSC. The Development Plan shall specify, among other things, (a) all material Development activities reasonably anticipated to be undertaken by Licensee to obtain Regulatory Approval of the one or more TAK-385 Licensed Products in the Field in the Licensee Territory and in the Men’s Health Field in the Takeda Territorykey objectives, (b) all Licensee Development Activities in the Takeda Territoryand related Manufacturing activities to be performed with respect to a Licensed Compound, including Initiation of Clinical Trials, (c) all Initial Development Activitiesthe Party responsible for performance of an activity, (d) estimated dates on which Licensee expects the number and types of FTEs to achieve each be assigned to specific activities by SYNTA, (e) anticipated costs to be incurred under the Development Milestone Event, including Plans (the filing of an NDA in each country in “Budget”) for the Licensee Territory in which Licensee is Developing a TAK-385 Licensed Productapplicable twelve (12) month period, and (ef) an estimate Development timelines. For the sake of costs and expenses associated with clarity, neither the activities set forth in the TAK-385 initial Development Plan. The initial TAK-385 Plans attached hereto, nor any subsequent Development Plan is attached hereto as Schedule 5.3 (TAK-385 Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (i) [***]; and (ii) [***], in each case consistent with the activities described in the initial TAK-385 Development Plan attached hereto as Schedule 5.3 (TAK-385 Development Plan). Licensee will prepare an update to the TAK-385 Development Plan at least annually. Licensee may amend the TAK-385 Development Plan as reasonable or necessary at any time during the Term; provided that all annual updates and any material amendments must be reviewed, discussed, and, solely with respect to any Development activities in the Takeda Territory, approved, once agreed by the JRC in accordance with Section 2.2.2(a) (Establishment; Responsibilities)Parties, and provided, further, that all such updates or material amendments to may be amended except by mutual agreement of the TAK-385 Development Plan must be in accordance with the requirements of this Article 5 (Development). No update or amendment to the TAK-385 Development Plan related to Development activities in the Takeda Territory will be effective unless approved by the JRC in accordance with Article 2 (Governance). Licensee will provide Takeda with a copy of all updates or amendments to the TAK-385 Development PlanParties.

Development Plans. During [*], Betta will provide a development plan for the Territory in reasonable details including the clinical trials to be conducted for each Licensed Antibody, and a timeline for such Development (“Initial Territory Development Plan”) to the JSC for discussion and approval. A more comprehensive development plan describing in reasonable detail the proposed overall program of Development for the Licensed Product(s) containing such Licensed Antibodies in each region in the Territory, including preclinical and non-clinical studies, toxicology, formulation, plans for preparation and filing of INDs, indications for each Licensed Antibody to be Developed by Betta, Clinical Trials and regulatory plans and other key elements necessary to obtain Regulatory Approvals for such Licensed Product(s) (each, together with the Initial Territory Development Plan, a “Territory Development Plan”) will be provided by Betta to the JSC for discussion and approval [*]. Each Territory Development Plan will be updated at least annually by Betta, and submitted to the JSC for review and approval not later than June 30 of each calendar year during the Term. Each new or updated Territory Development Plan will include, Licensee with respect to each Licensed Product, an outline of an overall plan for such Licensed Product that sets forth all major Development tasks remaining to be accomplished prior to submission of INDs and, once Clinical Trials in the Territory have commenced, filings for Regulatory Approvals to the extent such tasks are known or can reasonably be ascertained. Betta will conduct Develop each Licensed Antibody and Licensed Product in the Field and in the Territory in accordance with the applicable Territory Development Plan. Betta will be solely responsible for all Development activities costs and expenses in connection with the TAK-385 Development of Licensed Compound or any TAK-385 Licensed Product in accordance with the terms Antibodies and conditions set forth in this Article 5 (Development) and the plan for Development activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products (as such plan may be amended from time to time pursuant to this Section 5.3 (Development Plans) (with respect to the TAK-385 Development Plan), a “TAK-385 Development Plan”). [***]. The TAK-385 Development Plan will include reasonably detailed descriptions of: (a) all material Development activities reasonably anticipated to be undertaken by Licensee to obtain Regulatory Approval of the one or more TAK-385 Licensed Products in the Field in the Licensee Territory and in the Men’s Health Field in the Takeda Territory, (b) all Licensee Development Activities in the Takeda Territory, (c) all Initial Development Activities, (d) estimated dates on which Licensee expects to achieve each Development Milestone Event, including the filing of an NDA in each country in the Licensee Territory in which Licensee is Developing a TAK-385 Licensed Product, and (e) an estimate of costs and expenses associated with the activities set forth in the TAK-385 Development Plan. The initial TAK-385 Development Plan is attached hereto as Schedule 5.3 (TAK-385 Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (i) [***]; and (ii) [***], in each case consistent with the activities described in the initial TAK-385 Development Plan attached hereto as Schedule 5.3 (TAK-385 Development Plan). Licensee will prepare an update to the TAK-385 Development Plan at least annually. Licensee may amend the TAK-385 Development Plan as reasonable or necessary at any time during the Term; provided that all annual updates and any material amendments must be reviewed, discussed, and, solely with respect to any Development activities in the Takeda Territory, approved, by the JRC in accordance with Section 2.2.2(a) (Establishment; Responsibilities), and provided, further, that all such updates or material amendments to the TAK-385 Development Plan must be in accordance with the requirements of this Article 5 (Development). No update or amendment to the TAK-385 Development Plan related to Development activities in the Takeda Territory will be effective unless approved by the JRC in accordance with Article 2 (Governance). Licensee will provide Takeda with a copy of all updates or amendments to the TAK-385 Development Plan.

Development Plans. The Development of the Product in the Territory under this Agreement shall be governed by the Global Development Plan and Territory Specific Development Plan, which may be revised from time to time in accordance with this Section 3.3. During the Term, Licensee will conduct all the Global Development Plan and Territory Specific Development Plan shall contain in reasonable detail the major THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Development and regulatory activities in connection with the TAK-385 Licensed Compound conducted by or any TAK-385 Licensed Product in accordance with the terms and conditions set forth in this Article 5 on behalf of Zai (Developmentor its Affiliates or Sublicensees), including those necessary to (i) and the plan for Development activities with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products (as such plan may be amended from time to time pursuant to this Section 5.3 (Development Plans) (with respect to Territory Specific Activities under the TAK-385 Global Development Plan), a “TAK-385 conduct the [***] in Section 3.2(a)(ii) above, (ii) seek Regulatory Approval and progress clinical Development Plan”). for (A) Margetuximab [***]. The TAK-385 Development Plan will include reasonably detailed descriptions of: , (aB) all material Development activities reasonably anticipated to be undertaken by Licensee to obtain Regulatory Approval of the one or more TAK-385 Licensed Products Margetuximab [***] in the Field in the Licensee Territory and in the Men’s Health Field in the Takeda Territory, (b) all Licensee Development Activities in the Takeda Territory, (c) all Initial Development Activities, (d) estimated dates on which Licensee expects to achieve each Development Milestone Event, including the filing of an NDA in each country in the Licensee Territory in which Licensee is Developing a TAK-385 Licensed Product, and (e) an estimate of costs and expenses associated with the activities set forth in the TAK-385 Development Plan. The initial TAK-385 Development Plan is attached hereto as Schedule 5.3 (TAK-385 Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (iC) [***]; and (ii) ] Clinical Trials that include [***], in each case consistent with the activities described of (A) through (C) in the initial TAK-385 Development Plan attached hereto Territory and subject to review and change as Schedule 5.3 set forth in Section 3.3(b), and (TAK-385 Development Plan). Licensee will prepare an update to iii) the TAK-385 Development Plan at least annually. Licensee may amend the TAK-385 Development Plan as reasonable estimated timelines for achieving such activities until such Regulatory Approval in each Country or necessary at any time during the Term; provided that all annual updates and any material amendments must be reviewed, discussed, and, solely with respect to any Development activities Region in the Takeda Territory, approved, by the JRC in Territory has been obtained. In accordance with Section 2.2.2(a) (Establishment; Responsibilities2.1(b)(ii), the JDC shall review and provided, further, that all such updates or material amendments submit to the TAK-385 JSC for approval, and the JSC shall review and approve the Global Development Plan must be in accordance with the requirements of this Article 5 (Development). No update or amendment to the TAK-385 and each Territory Specific Development Plan related to Development activities in the Takeda Territory will be effective unless approved by the JRC in accordance with Article 2 (Governance). Licensee will provide Takeda with a copy of all and any updates or amendments to the TAK-385 Global Development Plan or a Territory Specific Development Plan. The initial Global Development Plan and Territory Specific Development Plan are attached hereto as Exhibit C. To the extent the Development activities and Clinical Trials contemplated under 3.3(ii) are not included under the Global Development Plan, such Development activities and Clinical Trials shall be included under the Territory Specific Development Plan, unless otherwise mutually agreed by the Parties in writing. For clarity, Zai shall not be permitted to exercise its unilateral decision-making authority under Section 2.1(d)(ii)(A) to reduce or eliminate Zai’s obligations to conduct the Development activities and Clinical Trials contemplated by the foregoing 3.3.