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 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) [***] Program Before Opt-In and MGNX Option Program. [***], the Parties will jointly conduct Development activities pursuant to a Global Development Plan and a Territory-Specific Development Plan for such Collaboration Program; provided that, with respect to the [***] Program, the Parties will so conduct the Development activities unless and until Zai elects to exercise its Opt-In pursuant to Section 5.1(e). Subject to Section 5.1(a)(ii), no later than [***] prior to the date the Parties reasonably [***], the Parties shall mutually prepare a Global Development Plan and a Territory-Specific Development Plan for such Collaboration Program for the JSC’s review and approval. Each Global Development Plan and Territory-Specific Development Plan shall set forth in reasonable detail the major Development and regulatory activities to be conducted by or on behalf of each Party (or its Affiliates or Sublicensees) and the estimated timelines for achieving such activities to obtain Regulatory Approval in each country or Region in the applicable Collaboration Territory. Pursuant to each Global Development Plan and Territory-Specific Development Plan for a Collaboration Program Zai shall be primarily responsible for conducting Clinical Trials in the applicable Collaboration Territory, and MacroGenics shall be primarily responsible for conducting Clinical Trials outside the applicable Collaboration Territory. The JSC shall review each Global Development Plan and Territory-Specific Development Plan no less than [***] and make updates as appropriate, and the JRDC shall oversee and facilitate cooperation and information transfer between the Parties in conducting the activities set forth in the Global Development Plan and Territory-Specific Development Plan. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED (ii) [***]] Program After Opt-In. If Zai exercises the [***] Profit Share Option pursuant to Section 5.1(e) the Parties shall mutually prepare a Co-Development Plan within [***] of Zai’s exercise of the [***] Profit Share Option for the JRDC’s review and approval; provided that, if there is a Global Development Plan or Territory Specific Development Plan in effect at such time, the Co-Development Plan shall replace such Global Development Plan or Territory Specific Development Plan. The Co-Development Plan shall set forth in reasonable detail (1) the major Development and regulatory activities to be conducted by or on behalf of each Party (or its Affiliates or Sublicensees), (2) the estimated timelines for achieving such activities to obtain Regulatory Approval in each case consistent with country or Region in the world, and (3) the respective budgets for the Development of the applicable [***] Product (A) under the Research Plan, if ongoing, (B) in the [***] Opt-In Territory, and (C) in the ROW. Pursuant to the Co-Development Plan and unless otherwise specified therein, Zai shall be primarily responsible for finishing all Clinical Trials it is conducting in the [***] Territory at the time of the Opt-In and conducting Clinical Trials in the [***] Opt-In Territory that will be initiated after the Opt-In, and MacroGenics shall be primarily responsible for finishing all Clinical Trials it is conducting outside the [***] Territory at the time of the Opt-In and conducting Clinical Trials in all countries in the ROW that will be initiated after the Opt-In. The JSC shall review the Co-Development Plan no less than [***] and make updates as appropriate, and the JRDC shall oversee and facilitate cooperation and information transfer between the Parties in conducting the activities described set forth 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 Co-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.

Development Plans. During (a) Licensee shall prepare and deliver to ▇▇▇▇▇▇▇ within […***…] after the TermEffective Date a written development plan for the AR Mutant Program describing the activities to be performed to up to and including the conduct and completion of the AR Mutant POC Trial and the AR Mutant Pre-Phase III Activities, the deliverables for such activities, target dates and estimated timelines for completion of such activities and a budget for such activities (the “AR Mutant Development Plan”). The Development Plan for the AR Mutant Program shall at all times contain […***…]. ▇▇▇▇▇▇▇ shall review the initial AR Mutant Development Plan within […***…] following receipt thereof and may provide comments on such AR Mutant Development Plan, which Licensee will conduct all shall consider in good faith. Any portion of the initial AR Mutant Development activities in connection with the TAK-385 Licensed Compound or any TAK-385 Licensed Product in accordance with the terms and conditions Plan describing a ▇▇▇▇▇▇▇ AR Mutant Activity that is not set forth on Schedule ▇▇▇▇▇▇▇ AR Mutant Activities, or setting forth a target date or timeline for any ▇▇▇▇▇▇▇ AR Mutant Activity, will not become effective unless and until approved in this Article 5 writing by ▇▇▇▇▇▇▇. (Developmentb) Licensee shall prepare and deliver to ▇▇▇▇▇▇▇ within […***…] after the Effective Date a written development plan for the NIK Program describing the activities to be performed to up to and including the conduct and completion of the NIK POC Trial, the deliverables for such activities, target dates and estimated ***Confidential Treatment Requested timelines for completion of such activities and a budget for such activities (the “NIK Development Plan” and the plan AR Mutant Development Plan or the NIK Development Plan, a “Development Plan”). The Development Plan for the NIK Program shall at all times contain: […***…]. ▇▇▇▇▇▇▇ shall review the initial NIK Development activities with respect Plan within […***…] following receipt thereof and may provide comments on such NIK Development Plan, which Licensee shall consider in good faith. (c) Subject to the TAK-385 Licensed Compound Section 2.2.2(a) or 2.2.2(b), as applicable, and TAK-385 Licensed Products (as such plan Section 2.2.2(e), each Development Plan may be amended from time to time pursuant to this Section 5.3 by Licensee, provided that no such amendment shall take effect until (Development Plansi) Licensee provides ▇▇▇▇▇▇▇ with notice of and a copy of the proposed amendment, (ii) Licensee provides ▇▇▇▇▇▇▇ with respect to the TAK-385 Development Plan), a “TAK-385 Development Plan”). […***]…] to review and provide comments on such amendment and (iii) Licensee considers in good faith any comments made by ▇▇▇▇▇▇▇; and provided further that no such amendment relating to a ▇▇▇▇▇▇▇ AR Mutant Activity shall take effect unless and until approved in writing by ▇▇▇▇▇▇▇. The TAK-385 For clarity, the approval of ▇▇▇▇▇▇▇ is not required to amend any 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 except as described 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, immediately preceding sentence. (d) estimated dates on which Prior to the commencement of any of the […***…], Licensee expects shall amend the AR Mutant Development Plan to achieve each Development Milestone Event, including the filing of an NDA in each country in the Licensee Territory in which Licensee is Developing include a TAK-385 Licensed Product, budget for such activities and submit such amendment to ▇▇▇▇▇▇▇ for review pursuant to Section 2.2.2(c). (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 for a Program shall not contain any Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (i) activities relating to […***…]; , and (ii) [Licensee shall not conduct any such activities during the Development Term of such Program. ***], 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.Confidential Treatment Requested

Development Plans. During (a) Confidential Treatment Requested Licensee shall prepare and deliver to ▇▇▇▇▇▇▇ within [...***...] after the TermEffective Date a written development plan for the AR Mutant Program describing the activities to be performed to up to and including the conduct and completion of the AR Mutant POC Trial and the AR Mutant Pre-Phase III Activities, the deliverables for such activities, target dates and estimated timelines for completion of such activities and a budget for such activities (the “AR Mutant Development Plan”). The Development Plan for the AR Mutant Program shall at all times contain [...***...]. ▇▇▇▇▇▇▇ shall review the initial AR Mutant Development Plan within [...***...] following receipt thereof and may provide comments on such AR Mutant Development Plan, which Licensee will conduct all shall consider in good faith. Any portion of the initial AR Mutant Development activities in connection with the TAK-385 Licensed Compound or any TAK-385 Licensed Product in accordance with the terms and conditions Plan describing a ▇▇▇▇▇▇▇ AR Mutant Activity that is not set forth on Schedule ▇▇▇▇▇▇▇ AR Mutant Activities, or setting forth a target date or timeline for any ▇▇▇▇▇▇▇ AR Mutant Activity, will not become effective unless and until approved in this Article 5 writing by ▇▇▇▇▇▇▇. (Developmentb) Licensee shall prepare and deliver to ▇▇▇▇▇▇▇ within [...***...] after the Effective Date a written development plan for the NIK Program describing the activities to be performed to up to and including the conduct and completion of the NIK POC Trial, the deliverables for such activities, target dates and estimated timelines for completion of such activities and a budget for such activities (the “NIK Development Plan” and the plan AR Mutant Development Plan or the NIK Development Plan, a “Development Plan”). The Development Plan for the NIK Program shall at all times contain: [...***...]. ▇▇▇▇▇▇▇ shall review the initial NIK Development activities with respect Plan within [...***...] following receipt thereof and may provide comments on such NIK Development Plan, which Licensee shall consider in good faith. (c) Subject to the TAK-385 Licensed Compound Section 2.2.2(a) or 2.2.2(b), as applicable, and TAK-385 Licensed Products (as such plan Section 2.2.2(e), each Development Plan may be amended from time to time pursuant to this Section 5.3 by Licensee, provided that no such amendment shall take effect until (Development Plansi) Licensee provides ▇▇▇▇▇▇▇ with notice of and a copy of the proposed amendment, (ii) Licensee provides ▇▇▇▇▇▇▇ with respect to the TAK-385 Development Plan), a “TAK-385 Development Plan”). [...***]...] to review and provide comments on such amendment and (iii) Licensee considers in good faith any comments made by ▇▇▇▇▇▇▇; and provided further that no such amendment relating to a ▇▇▇▇▇▇▇ AR Mutant Activity shall take effect unless and until approved in writing by ▇▇▇▇▇▇▇. The TAK-385 For clarity, the approval of ▇▇▇▇▇▇▇ is not required to amend any 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 except as described 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, immediately preceding sentence. (d) estimated dates on which Prior to the commencement of any of the [...***...], Licensee expects shall amend the AR Mutant Development Plan to achieve each Development Milestone Event, including the filing of an NDA in each country in the Licensee Territory in which Licensee is Developing include a TAK-385 Licensed Product, budget for such activities and submit such amendment to ▇▇▇▇▇▇▇ for review pursuant to Section 2.2.2(c). (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 for a Program shall not contain any Development Plan). Without limiting the foregoing, the TAK-385 Development Plan will provide that Licensee conduct (i) activities relating to [...***]; and (ii) [***...], in each case consistent with the and Licensee shall not conduct any such 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 Term of 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 PlanProgram.