Global Development Plan. During the License Term for each Licensed Program, the Development of Licensed Products under this Agreement under such Licensed Program shall be conducted pursuant to a reasonably comprehensive written research and development plan (each, a “Global Development Plan”), which shall include a detailed budget for all Development Costs and Manufacturing Process Development Costs (each, a “Development Budget”), and which shall include the resource allocations for the Parties based upon the general principle that the allocation shall endeavor to take advantage of the respective resources, capabilities and expertise of MacroGenics and Servier, respectively. Within *** after the License Grant Date, the JRDC shall prepare an initial draft of the Global Development Plan for approval by the JSC for such Licensed Program. Each Global Development Plan also shall set forth the specific activities (including non-clinical and clinical studies to be conducted by each Party) and the estimated timeline for Development of Licensed Products licensed under such Licensed Program in order to obtain the data that the Parties intend will be useful, by both Parties, to obtain Regulatory Approvals of the Licensed Products in both the United States, and the EU. Servier shall be the sponsor of all clinical studies conducted in the Servier Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the Servier Territory, and MacroGenics shall be the sponsor of all clinical studies conducted in the MacroGenics Territory and shall be solely responsible for Development activities and for obtaining Regulatory Approval for Licensed Products in the MacroGenics Territory. The JRDC shall discuss which Party(ies) shall be the sponsor of all clinical studies conducted in countries of both the MacroGenics Territory and the Servier Territory under such Licensed Program.
Global Development Plan. Nanobiotix’s global Development of the Licensed Product outside of the Territory will be conducted pursuant to a written plan (the “Global Development Plan”). Prior to the first Phase III Trial for any Licensed Product, Nanobiotix will provide the initial Global Development Plan to the JSC for its review, discussion, and [***] regarding activities to be conducted in the Territory, approval. The Global Development Plan will include an outline of all major Development activities for the Licensed Product to be conducted throughout the world by Nanobiotix. From time to time, Nanobiotix may propose updates to the then-current Global Development Plan for the Licensed Products, to the JSC to review and discuss and [***] regarding activities to be conducted in the Territory, approval.
Global Development Plan. The JDC will oversee the Development of Shared Products by the Parties in the Field in the Territory. Each Shared Product will be Developed in accordance with a global development plan (the “Global Development Plan”). The Global Development Plan will include a plan for the Development of the Shared Product in the Territory through Regulatory Approval, including a regulatory strategy, high-level study design criteria, an allocation of responsibilities between the Parties, timelines and a budget for activities conducted under the Global Development Plan (the “Development Budget”). The JDC will update the Global Development Plan [***] (or more frequently as needed) and submit it to the JSC for approval. The Parties will establish a project team (the “Project Team”) to oversee and coordinate activities under the Global Development Plan. The Project Team be formed with an experienced team leader (“Project Leader”), and the composition of the Project Team will be determined by the Project Leader based on available personnel from each Party across functions. The Project Team will conduct its responsibilities under the Global Development Plan in good faith and with reasonable care and diligence. The Project Team will provide the JDC with periodic updates regarding the progress of activities pursuant to the Global Development Plan.
Global Development Plan. From time to time, in order to facilitate the Development of Products on a worldwide basis, a Party, acting through its representatives on the Steering Committee, may propose that certain Development activities be performed in coordination between the Parties in accordance with a written plan (the “Global Development Plan”). If approved by the Steering Committee for inclusion in the Global Development Plan, such Development activities shall be incorporated in appropriate detail into a written amendment of the Global Development Plan. If not approved by the Steering Committee for inclusion in the Global Development Plan, such Development [***] Confidential Treatment Requested Confidential portion omitted and filed separately with the Commission activities may be performed by a Party to the extent in accordance with Section 4.1 above. Except as expressly provided in this Agreement or agreed in writing by the Parties, each Party shall be solely responsible for the expenses of performing its responsibilities under the Global Development Plan.
4.2.1. In addition, if ADLS or a Licensee decides to conduct any clinical studies with respect to any proposed future Product, ADLS shall give written notice of such decision to Wyeth with a brief description of the proposed Product and clinical studies. If, after receipt of such notice, Wyeth notifies ADLS that Wyeth has a good faith interest in Developing and Commercializing such Product in the Territory, then such clinical studies shall be added to the Global Development Plan pursuant to an amendment of the Global Development Plan to be approved by the Steering Committee in accordance with this Agreement.
4.2.2. During the Term, the Global Development Plan may be updated from time to time as deemed necessary by the Steering Committee.
4.2.3. Each Party shall provide to the other Party or the Steering Committee, as appropriate, such information in its Control and relevant to the Development of Products as may be necessary or appropriate in connection with updating the Global Development Plan. Each modification or update of the Global Development Plan shall be subject to review and approval of the Steering Committee.
Global Development Plan. (a) NVCR’s global Development of Licensed Products will be conducted pursuant to a written development plan (as amended from time to time in accordance with this Section 5.3, the “Global Development Plan”), which the Parties agree shall include (i) TT Fields Multi-Regional Clinical Studies for (1) the NSCLC Indication, (2) the pancreatic cancer Indication, and (3) the ovarian cancer Indication, for each of which, Zai [***]; and (ii) a [***].
(b) The Parties shall discuss and agree upon the initial Global Development Plan within [***] days following the Effective Date. In addition to Zai’s Development activities under the Territory Development Plan, Zai shall [***] Global Development Plan. The Global Development Plan shall include (i) an outline only of NVCR’s global Clinical Trials for Licensed Products, (ii) details and timelines of the [***], (iii) details and timelines of any other Development activities [***], and (iv) [***] Global Development Plan [***], which for each of the TT Fields Multi-Regional Clinical Studies for the NSCLC Indication, the pancreatic cancer Indication and the ovarian cancer Indication, shall be up to [***], using its Commercially Reasonable Efforts.
(c) From time to time, NVCR may make and implement amendments to the then-current Global Development Plan. To the extent such amendments are (x) material, and (y) relate to the Territory, NVCR shall submit such proposed amendments to the JSC for review and discussion before adopting such amendments.
Global Development Plan. On a Global Target-by-Global Target basis, the Development activities that are necessary or useful to be undertaken for the applicable Global Antibody Candidates or Global Licensed Products to achieve initial Regulatory Approval for each of the Indications selected by Novartis using Commercially Reasonable Efforts in the Major Market Countries (including the design of CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. the initial Phase 1 Study) will be set forth in reasonable detail in a written work plan and time table (each, a “Global Development Plan”). The initial Global Development Plan for each Global Target will be included in the Option IND Package for such Global Target provided by Surface to Novartis under Section 4.2.2. The terms of, and Development activities set forth in, each Global Development Plan will at all times be designed to be in compliance with all applicable Laws and in accordance with professional and ethical standards customary in the pharmaceutical industry. Novartis will update the Global Development Plan for such Global Antibody Candidates and Global Licensed Products [***] and will provide such updated Global Development Plan to the JDC.
Global Development Plan. The JDC will oversee the Development of the Shared Products and the Research of Follow-On Products by the Parties in the Field in the Territory. The Shared Products will be Developed in accordance with a global development plan (the “Global Development Plan”), which will include the Development Budget (as defined below), which will be prepared by the Project Team within [***] days after the Effective Date and shall be approved by the JDC thereafter. Unless otherwise agreed by the Parties in writing, the Global Development Plan will at all times include a plan for the Development of the Shared Products in the Territory through Regulatory Approval, including a regulatory strategy, high-level study design criteria, an allocation of responsibilities between the Parties, timelines and a budget for activities conducted under the Global Development Plan (the “Development Budget”). Until such time as the initial Development Budget has been established in accordance with this Agreement, each Party will incur Program Expenses in a manner substantially consistent with the plans and budgets previously discussed by the Parties and such Program Expenses will be shared as provided in ARTICLE 7. On [***] basis (or more frequently as needed), the Project Team will update the Global Development Plan and will submit the updated Global Development Plan to the JDC for review and discussion. The JDC will review and discuss the updated Global Development Plan and submit such updated Global Development Plan to the JSC for review, discussion and approval. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents
Global Development Plan. The Parties’ global Development of the Licensed Product inside and outside of the Territory will be conducted pursuant to a written plan (as updated from time to time in accordance with this Section 5.3 (Global Development Plan), the “Global Development Plan”). The initial Global Development Plan for the Licensed Product is set forth on Schedule 5.3 (Global Development Plan) attached hereto. Other than any Clinical Development for the Licensed Product to be performed by Partner under the Global Development Plan (if Partner either requests or is requested to serve as Territory Sponsor, and agrees, following review and discussion by the JSC, to serve as the Territory Sponsor for such trials in accordance with this Agreement), Kiniksa will have the right to conduct all Development activities for the Licensed Product, including all non-clinical and preclinical studies for the Licensed Product worldwide, pursuant to the Global Development Plan (and solely pursuant to the Global Development Plan as it relates to the Territory) and will have the exclusive right to conduct Development activities for the Licensed Product outside the Territory. In addition to Partner’s exclusive right to conduct Territory Development activities for the Licensed Product included in the Territory Development Plan, Partner will have the right to request (or to consent, if Kiniksa so requests of Partner), in each case, following review and discussion by the JSC, and permitted under Applicable Law (and subject to Partner agreeing to bear its share of costs for such Global Clinical Trial in accordance with Section 5.7.2 (Global Development Costs)), to support the global Development of the Licensed Product by serving as Territory Sponsor for and otherwise participating in the conduct of certain Global Clinical Trials, including, to the extent practicable, any Ongoing Global Clinical Trial, and other Clinical Development activities in the Territory as set forth in, and in accordance with, the Global Development Plan. Following any determination that Partner will serve as Territory Sponsor for a given Global Clinical Trial:
Global Development Plan. Lyra’s global Development of the Licensed Product outside of the Territory and, [***], clinical Development within the Territory will be conducted pursuant to a written plan (the “Global Development Plan”). [***], Lyra will provide to the JSC for its review and discussion the initial Global Development Plan. The Global Development Plan will include an outline of all major Development activities for the Licensed Product to be conducted throughout the world by Lyra. From time to time, Lyra may propose updates to the then-current Global Development Plan for the Licensed Products, to the JSC to review and discuss and, solely to the extent relating to activities to be conducted by Lian in the Territory, to determine whether to approve such activities.
Global Development Plan. The following new Section 5.2(d) is hereby appended to Section 5.2 of the Agreement to the end thereof:
