Specific Responsibilities of the JSC. The responsibilities of the JSC will be to:
(a) oversee the overall strategic relationship between the Parties;
(b) review, discuss, and approve each Research Plan (including the applicable Research Budget set forth therein), and each amendment or update thereto;
(c) review, discuss, develop, and approve the Success Criteria (or any modification thereto) for Candidates that Modulate each Target;
(d) review and discuss each Interim Report, each Success Criteria Report, and the Exploratory Research Report;
(e) review, discuss, and determine whether any Candidate identified in the Success Criteria Report has achieved the Success Criteria for Candidates that Modulate such Target;
(f) facilitate the flow of information (including Development Reports) between the Parties with respect to the Development and Commercialization of Ophthalmic Candidates, Ophthalmic Products, [***] Candidates in the Ex-Vivo Field, and [***] Products in the Ex-Vivo Field;
(g) review and discuss any proposed sublicenses to whom NVS proposes to grant rights to Develop or Commercialize In-Vivo [***] Products;
(h) review and discuss the Development Plan for In-Vivo [***] Products and all material amendments or updates thereto;
(i) develop, discuss, and approve the initial high-level summary (including the associated budget) of marketing strategy and Commercialization activities for In-Vivo [***] Products, and each material amendment or update to such plans and budgets;
(j) review, discuss, and approve the Global In-Vivo [***] Commercialization Plan and the U.S. In-Vivo [***] Commercialization Plan (including the applicable Commercialization Budgets set forth therein), and all material amendments or updates to such plans and budgets;
(k) review and discuss the status and progress of regulatory activities for In-Vivo [***] Products and provide any comments to NVS with respect to any Jointly-Agreed Regulatory Submissions for In-Vivo [***] Products;
(l) review, discuss, and approve each Global Medical Affairs Plan and U.S. Medical Affairs Plan, progress under such plans, and all material amendments or updates thereto;
(m) review, discuss, and approve the initial Global Brand Plan for In-Vivo [***] Products, and each material amendment and update thereto;
(n) upon request of a Party, develop and discuss whether to approve a Territory-specific brand plan for U.S. [***] Products;
(o) review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to In-Vivo [...
Specific Responsibilities of the JSC. In addition to its overall responsibilities described in Section 2.4.1, and subject to the provisions of Section 2.7.3 and Article 6, the JSC shall, in particular:
(a) select which Party and/or Third Party(ies) to engage for the Manufacture and supply of Collaboration Products and components thereof (“Third Party Manufacturers”), oversee auditing of Third Party Manufacturers, and approve contracts governing such Manufacture and supply;
(b) delineate requirements and responsibilities for development and licensure of manufacturing processes and facilities for Collaboration Products and for worldwide supply of Collaboration Products;
(c) jointly develop a Manufacturing strategy for the US Territory and the ROW Territory to enable development and licensure of manufacturing processes and facilities for Collaboration Products that includes all aspects of Manufacture and release, including but not limited to formulations, intermediate, dosage form, devices, product characterization studies, test methods and process validation studies, stability studies and Manufacturing plans and forecasts and the implementation of Manufacturing Improvements;
(d) determine Manufacturing plans and budgets, including timelines and inventory strategies, and allocate responsibilities for and oversee the implementation of such plans in accordance with this Agreement;
(e) oversee and approve process development plans prior to the Manufacture of registration batches of Collaboration Products;
(f) oversee and approve plans to support Manufacture of commercial supply of Compound and Collaboration Products;
(g) review quality assurance efforts, including but not limited to those efforts with respect to the establishment of specifications and quality standards for Collaboration Products;
(h) review and coordinate the drafting and contents of the Chemistry, Manufacturing and Controls section of a Drug Approval Application for Collaboration Products;
(i) review and approve technology transfer plans for any changes in Manufacturing sites, testing sites, and responsibilities in the supply chain for Collaboration Products, it being understood that decisions regarding the selection of which of a Party’s own Manufacturing and testing sites shall be used to manufacture any component of a Collaboration Product, if a Party Manufactures any component of a Collaboration Product pursuant to this Agreement or any related supply agreement, shall remain in the sole control of such Party;
(j) prepare for re...
Specific Responsibilities of the JSC. On an Fcab-by-Fcab and a mAb2-by-mAb2 basis, until the expiration of the License Option Term for such Accepted Fab Target, the JSC shall review the strategy for the Development of mAb2s. In particular, at each meeting the JSC shall:
2.2.1 discuss Denali’s Technical Development.
2.2.2 discuss the suitability of an Fcab Target for the generation of Fcabs and mAb2 pursuant to Section 3.1.5.
2.2.3 agree on the Fcab Discovery Plan for each Accepted Fcab Target, based on the Fcab Discovery Plan for the TfR Accepted Fcab Target which is appended as Schedule 1.51;
2.2.4 agree on (i) the Fcab Delivery Criteria for each Accepted Fcab Target, based on the Fcab Delivery Criteria for the TfR Accepted Fcab Target which are set out in Schedule 1.51; and (ii) the protocol for the validation experiment(s) required for the Fcab Delivery Criteria.
2.2.5 review and discuss the conduct of research and Development activities under each Fcab Discovery Plan, until all activities to be performed thereunder have been completed;
2.2.6 discuss the progress of research and Development activities under each mAb2 Development Plan and to agree any activities that Denali requests that F-star undertakes in relation to the conduct such mAb2 Development Plan in each case for each mAb2 until all activities to be performed thereunder have been completed;
2.2.7 agree on a policy for publications, presentations or public disclosures related to a Selected Fcab during the Buy-out Option Period and to consider any proposed publications specifically;
2.2.8 establish Working Groups as necessary;
2.2.9 perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Specific Responsibilities of the JSC. In addition to its general responsibilities set forth in Section 5.1.1, the JSC shall, in particular, have responsibility to:
(a) oversee and coordinate the Development activities;
(b) review, provide comments relating to, and approve each Development Plan, and any modifications thereof or amendments thereto, to ensure that the Development Plan is designed to meet the Development diligence objectives set forth in Section 2.1;
(c) review, provide comments relating to, and approve each Commercialization Plan, and any modifications thereof or amendments thereto, to ensure that the Commercialization Plan is designed to meet the Commercialization diligence objectives set forth in Sections 3.1 and 3.2;
(d) review and provide comments to the pricing strategy for each Product (as included in the Commercialization Plan), subject to the provisions of Section 3.1 and applicable Law;
(e) review the overall progress under the Product Plans;
(f) provide a forum for the Parties to discuss and attempt to resolve Disputes; and
(g) such other responsibilities as the Parties may allocate to the JSC.
Specific Responsibilities of the JSC. In addition to its overall responsibility under this Agreement for the Development and Commercialization of Licensed Compounds and Licensed Products, the JSC shall, in particular:
(a) coordinate the activities of the Parties hereunder;
(b) resolve any disputes or disagreements, including those arising from any Sub-Committee, or submit unresolved disputes or disagreements to the designated executive officers pursuant to Section 3.04 (Decision Making and JSC Dispute Resolution) and Article XV (Dispute Resolution, Governing Law);
(c) support Development and Commercialization efforts for Licensed Compounds and Licensed Products, including reviewing and discussing the strategy for the Development and Commercialization of Licensed Compounds and Licensed Products;
(d) make recommendations for approval by the Parties for [***] programs;
(e) subject to Section 4.02 (Development Plan), review and approve the Development Plan [***];
(f) review and approve any Development in the Territory for [***] of the DD-CKD Indication and NDD-CKD Indication;
(g) subject to Section 6.05 (Trademarks and International Nonproprietary Name), review and discuss the use in the Territory of the [***] for the Licensed Product, which shall be prepared by Akebia, and review and discuss the [***] for each country in the Territory, which shall be prepared by Licensee;
(h) review and discuss a [***] including supporting materials for a [***] for [***] taking into consideration [***] for the [***];
(i) review commercial and sales performance, and sales forecasts, of the Licensed Product in each country in the Territory; and
(j) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties, including the periodic evaluation of performance against goals.
Specific Responsibilities of the JSC. In addition to its overall responsibility for monitoring and providing general oversight with respect to the Parties’ activities under the Collaboration, the JSC shall in particular have the following responsibilities:
(i) periodic review of the overall goals, strategy and progress of each Development and Research Program and adjusting such goals and strategy of each Development and Research Program as needed;
(ii) with respect to each Collaboration Product, reviewing and approving the Development and Research Plan and making any revisions, updates or amendments to the Development and Research Plan, the Annual Development and Research Plan Budget for such Collaboration Product;
(iii) reviewing and approving the Commercialization Plan and its related budget in the Profit Share Territories;
(iv) with respect to each Collaboration Product, reviewing and approving any new Development for such Collaboration Product;
(v) periodic review of the overall goals, strategy and progress of the Commercialization of the Collaboration Products;
(vi) reviewing and approving the Global Branding Strategy for each Collaboration Product prepared by the JCC;
(vii) reviewing and approving New Third Party Licenses pursuant to Section 8.5(b);
(viii) coordinating the reporting of actual financial results for the Collaboration Products so as to ensure that each Party can timely comply with all of its reporting obligations;
(ix) resolution of matters presented to it by, and disputes raised to it by the Joint Research and Development Committee, the Joint Commercialization Committee, the Joint Intellectual Property Committee, the Joint Supply Committee or any other Subcommittee, in each case, that is within the scope of responsibilities delegated to the respective Subcommittee by the JSC under this Agreement and subject to final decision-making authority set forth in Section 2.5; and
(x) performing such other functions as appropriate, and directing each Subcommittee to perform such other functions as appropriate, to further the purposes of this Agreement and the Collaboration, in each case as mutually agreed in writing by the Parties.
Specific Responsibilities of the JSC. The JSC shall review the strategy for and oversee the Research Plans for the Collaboration Research of the RNAi Molecules and the Licensed Compounds directed to such Selected Target under each Research Plan. In particular, the JSC shall:
Specific Responsibilities of the JSC. In addition to its general responsibility to oversee, monitor, review, coordinate and provide strategic direction for the Product in the Territory, the JSC shall in particular:
18.6.2 and
18.6.3 and
Specific Responsibilities of the JSC. Until the expiration of the Research Collaboration Term with respect to a particular Target, the JSC shall review the strategy for and oversee the Development of the Licensed Product directed to such Target. In particular, the JSC shall:
2.2.1 agree on the C3 Work Plan and, with respect to any Optioned Complement Target, the applicable Complement Work Plan;
2.2.2 review and discuss the overall status of each Work Plan and the conduct of research and Development activities under the Work Plans;
2.2.3 review and discuss the results of each activity under the Work Plans, whether completed or ongoing;
2.2.4 review and agree to any amendment to a Work Plan;
2.2.5 review and discuss the prosecution strategy for Silence Research Patents and Joint Research Patents, including [***]
2.2.6 establish subcommittees to perform specific duties of the JSC, direct each such subcommittee to perform the functions for which it is established, and oversee each subcommittee, including resolution of disputes raised to the JSC by any subcommittee;
2.2.7 perform such other functions, and direct each subcommittee to perform such other functions, as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Specific Responsibilities of the JSC. The JSC shall be responsible for overseeing the activities of the Parties under the Research Program. In addition to its general responsibilities, the JSC shall in particular, without limitations:
(i) approve the Research Plan;
(ii) oversee the implementation of the Research Plan;
(iii) oversee the conduct of research according to the Research Plan;
(iv) decide on discontinuation of studies in the Research Plan;
(v) decide on possible additional studies in the Research Plan;
(vi) decide on possible amendment of scope of the Research Plan;
(vii) resolve possible non-scientific issues (e.g. logistics and financial) directly relating to the Research Plan;
(viii) facilitate the flow of Information between the Parties in relation to the Research Plan; and
(ix) perform such additional functions in relation to the Research Program as the Parties may jointly agree from time to time. The JSC shall not have any authority to amend the terms of this Agreement or to amend the level of any Development Milestone or Product Milestone or to expand the Research Plan beyond the Field.
