Common use of JSC Responsibilities Clause in Contracts

JSC Responsibilities. The JSC shall perform the following functions: (1) without prejudice to Clause 5.1(C)(3), at least [***] throughout the Term of this Agreement, review and discuss strategies and detailed plans (and progress against such plans) for the Development and Manufacture of Licensed Product in the Field and any Substantive Amendments (as defined below) to any such plans, as well as a more high-level review and discussion of the Commercialisation Plan; (2) review and discuss the high-level budgeted costs for Development and Manufacturing and actual spendings against such budgeted costs for each Calendar Quarter; (3) approve [***] the Development Plan, Manufacturing Plan and Technology Transfer Plan and (to the extent provided in this Agreement) any Commercialisation Plan for the subsequent Calendar Year, including budget and timelines, and subsequently during such Calendar Year approve any proposed Substantive Amendments to such plans; (4) discuss and approve any extension of any of the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Development Diligence Milestone as provided for in Clause 4.3(A)(4); (5) discuss and approve any proposal to Develop the [***] and the Development Plan for such [***]; (6) discuss and determine the need for any Third Party IPR licences, as provided for in Clause 6.8; (7) discuss and approve the need to use any platform technologies Controlled by Genmab, as set out in Clause 1.64, for the Development or Commercialisation of Licensed Product as contemplated in this Agreement; (8) discuss and approve [***]; (9) discuss and approve [***] (10) appoint sub-committees as appropriate to facilitate coordination and cooperation between the Parties or otherwise to further the purposes of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development Committee, unless otherwise indicated in this Agreement; (13) discuss and approve any proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(A); and (15) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment” means any change to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) months, and (iv) any other amendment which has any substantial effect on the timing, quality or costs of the activities thereby affected; and

JSC Responsibilities. The JSC shall perform have the following functionsresponsibilities with respect to the Ophthalmic Collaboration: (1a) without prejudice to Clause 5.1(C)(3), at least determining the overall Development strategy for the Programs and the Ophthalmic Products in the Field in the Territory; (b) evaluating and selecting [**] Additional Program Targets by no later than [**] throughout following the Term of this Agreement, review and discuss strategies and detailed plans Effective Date; (and progress against such plansc) reviewing for approval the Program Workplans for the Development and Manufacture Additional Programs (including without limitation, identifying each Clinical Study in such Program Workplans that is primarily in support of Licensed Regulatory Approval of a Profit-Sharing Product in the Field and any Substantive Amendments United States) within sixty (as defined below60) to any such plans, as well as a more high-level review and discussion days after the selection of the Commercialisation PlanAdditional Program Targets by the JSC, and reviewing for approval the related Development Expense budgets described in Section 2.11.3 within ninety (90) days after the selection of the Additional Program Targets by the JSC, in each case with appropriate input from ALNYLAM and MERCK senior management; (2d) review and discuss the high-level budgeted costs reviewing for Development and Manufacturing and actual spendings against such budgeted costs for each Calendar Quarter;approval (3i) approve [***] an annual update to each Program Workplan and the related Development PlanExpense budgets described in Section 2.11.3, Manufacturing Plan and Technology Transfer Plan and (to the extent provided in this Agreement) any Commercialisation Plan for the subsequent no later than December 31 of each Calendar Year, including budget and timelines, and subsequently during such Calendar Year approve (ii) any proposed Substantive Amendments modifications to such plans; Program Workplans and Development Expense budgets within thirty (430) discuss days of each submission to the JSC (including without limitation, identifying each Clinical Study in such updates and approve any extension modifications to such Program Workplans that is primarily in support of any Regulatory Approval of a Profit-Sharing Product in the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Development Diligence Milestone as provided for in Clause 4.3(A)(4United States); (5e) discuss determining each Party's responsibilities under the Program Workplans consistent with Section 2.5; (f) facilitating the transfer of Know-How and approve Information between the Parties for purposes of conducting the Program Workplans; (g) regularly assessing the progress of the Parties in their conduct of the Program Workplans and against the timelines and budgets contained therein, reviewing relevant data, considering issues of priority, and determining which Profit-Sharing Products to advance into clinical development; (h) reviewing for approval any proposal to Develop Manufacturing plans for Profit-Sharing Products and overseeing activities conducted thereunder; (i) reviewing for approval, within the Parties' regular business cycles, but no later than [***] and days after a proposal is made to the Development Plan JSC by either Party, the entry of any Profit-Sharing Product into IND-Enabling GLP Toxicology Studies; (j) reviewing for such approval, within the Parties' regular business cycles, but no later than [***]] days after a proposal is made to the JSC by either Party, the submission of an IND with respect to any Profit-Sharing Product; (6k) discuss and determine reviewing for approval the need for terms of any Third Party IPR licences, as provided for in Clause 6.8In-License under Section 2.15; (7l) discuss and approve the need to use any platform technologies Controlled by Genmab, as set out in Clause 1.64, reviewing for the Development or Commercialisation of Licensed Product as contemplated in this Agreement; (8) discuss and approve [***]; (9) discuss and approve [***] (10) appoint sub-committees as appropriate to facilitate coordination and cooperation between the Parties or otherwise to further the purposes of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development Committee, unless otherwise indicated in this Agreement; (13) discuss and approve any approval proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment Third Party collaborations in accordance with Clause 5.4(A)Section 2.6; and (15m) perform performing such other functions activities as appropriate to further the purposes of are contemplated under this Agreement as determined by or that the Parties. For Parties agree shall be the purposes responsibility of the foregoing: (i) the term “Substantive Amendment” means any change to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) months, and (iv) any other amendment which has any substantial effect on the timing, quality or costs of the activities thereby affected; andJSC.

JSC Responsibilities. The JSC shall perform the following functions: (1i) without prejudice review, coordinate and, in its discretion, approve the strategies for the Development, Commercialization and Manufacture of the Products in the Field in the Territory, and provide direction to Clause 5.1(C)(3)the DT, at least CT and ST as provided herein; (ii) approve the scope of the DT’s, CT’s and ST’s decision-making authority; (iii) except as otherwise provided herein, review and, in its discretion, approve by [***] throughout the Term of this Agreement, review and discuss strategies and detailed plans (and progress against such plans) for each calendar year the Development and Manufacture of Licensed Product in the Field and any Substantive Amendments (as defined below) to any such plans, as well as a more high-level review and discussion of the Commercialisation Plan; (2) review and discuss the high-level budgeted costs for Development and Manufacturing and actual spendings against such budgeted costs for each Calendar Quarter; (3) approve [***] the Development Plan, Manufacturing Plan and Technology Transfer Plan and (to the extent provided in this Agreement) any Commercialisation Plan for the subsequent Calendar Year, calendar year (including the Development Plan annual budget and timelines, and subsequently during the division of responsibilities between the Parties under such Calendar Year approve any proposed Substantive Amendments to such plans;plan); ** CONFIDENTIAL TREATMENT REQUESTED (4iv) discuss and review and, in its discretion, approve any extension of any of substantive amendments to the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Plan (including the Development Diligence Milestone as provided for in Clause 4.3(A)(4Plan annual budget); (5v) discuss and review and, in its discretion, approve any proposal to Develop the multiyear long-range plan for Development of the Products in the Field in the Territory (including the budget for Development Costs) formulated by the DT; (vi) review and, in its discretion, approve recommendations for further Development of the Products, including Development of the Products for a New Indication; (vii) review and, in its discretion, approve by [***] and of each calendar year the Development Commercialization Plan for such [***]the subsequent calendar year (including the Commercialization Plan annual budget); (6viii) discuss and determine review and, in its discretion, approve substantive amendments to the need for any Third Party IPR licences, as provided for in Clause 6.8Commercialization Plan (including the Commercialization Plan annual budget); (7ix) discuss and review and, in its discretion, approve the need to use any platform technologies Controlled multiyear long-range plan for Commercialization of the Products in the Field in the Territory (including the budget for Commercialization Costs) formulated by Genmab, as set out in Clause 1.64, for the Development or Commercialisation of Licensed Product as contemplated in this AgreementCT; (8) discuss x) review and, in its discretion, make a commercially reasonable determination whether the budget for Patent Costs prepared by the Patent Committee pursuant to Section 7.3 should be approved, and if appropriate, approve [***]the budget in accordance with such determination; (9) discuss and approve [***] (10) appoint sub-committees as appropriate to facilitate coordination and cooperation between the Parties or otherwise to further the purposes of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12xi) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development CommitteeDT, CT or ST, unless otherwise indicated in this Agreement; (13) discuss and approve any proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(A); and (15xii) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment” means any change to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) months, and (iv) any other amendment which has any substantial effect on the timing, quality or costs of the activities thereby affected; and.

JSC Responsibilities. The JSC shall perform be responsible for directing and overseeing the following functionsprogress of, and addressing any issues in connection with, each R&D Program. To that end, the JSC shall be responsible, without limitation, for the following: (1a) without prejudice to Clause 5.1(C)(3)discuss and decide the strategic direction of each R&D Program; (b) to allocate any unassigned activities under an R&D Plan; (c) to monitor, at least review and discuss the progress and results of all activities undertaken by the Parties under each R&D Plan and the allocation of resources among such activities; (d) to facilitate the exchange of information between the Parties in accordance with the R&D Plan; (e) to discuss, recommend updates for, amend and approve each R&D Plan (including the applicable R&D Budget) on an [***] throughout the Term (or at any other time in accordance with Section 2.3.3 (Review of this Agreement, review and discuss strategies and detailed plans R&D Plans)) (and progress against such plans) for the Development and Manufacture of Licensed Product including in the Field event Septerna reasonably believes that any R&D Plan Activity in such R&D Plan is technically infeasible to complete in accordance with Section 2.4.6 (Infeasible R&D Programs), to include additional R&D Plan Activities with respect to additional back-up or follow-on Program Compounds in accordance with Section 2.4.3(b) or Additional R&D Program Optimization Activities to be performed by Septerna in accordance with Section 2.4.4 (Additional R&D Program Optimization Activities), and to engage different subcontractors and update the R&D Budget accordingly in accordance with Section 2.9.3); provided that Novo Nordisk’s representatives on the JSC shall not have the right to approve any Substantive Amendments R&D Budget or amendment thereto without first receiving required internal governance approval of Novo Nordisk (as defined below) to any such plans, as well as a more high-level review and discussion outside of the Commercialisation Planpurview of the JSC); (2f) to (i) [***] and (ii) review and discuss the high-level budgeted costs for Development and Manufacturing and actual spendings against such budgeted costs G0 Data Package(s) for each Calendar Quarter; R&D Program and determine whether to progress existing Licensed Compounds under such R&D Program to Development to G1 Activities or to continue R&D Plan Activities to advance additional Program Compound(s) toward the G0 Criteria under such R&D Program, in each case, in accordance with Section 2.4.2 (3) approve [***] the Development Plan, Manufacturing Plan and Technology Transfer Plan and (to the extent provided in this Agreement) any Commercialisation Plan for the subsequent Calendar Year, including budget and timelines, and subsequently during such Calendar Year approve any proposed Substantive Amendments to such plans; (4) discuss and approve any extension of any of the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Development Diligence Milestone as provided for in Clause 4.3(A)(4Optimization Activities); (5g) to discuss and review the results of Novo Studies as described in Section 2.4.5 (Novo Studies); (h) to discuss and approve any proposal a Proposed New Program Plan in accordance with Section 2.6 (R&D Program Creation and Replacement Right); (i) if requested by Novo Nordisk, to Develop develop a plan outlining key transition activities to be carried out by Parties with respect to an R&D Program in accordance with Section 2.7 (Technology Transfer); (j) to receive, review and discuss the [***] Septerna Research FTE Costs and the Development Out-of-Pocket Costs incurred and expected to be incurred by or on behalf of Septerna or any of its Affiliates with respect to each R&D Plan for such [***](including any anticipated Budget Overruns in accordance with Section 2.9.2); (6k) to review, discuss and determine whether to use human biosamples in the need for any Third Party IPR licences, activities to be conducted pursuant to an R&D Plan as provided for described in Clause 6.8Section 2.10.2 (Human Biosamples); (7l) discuss to review and approve the need to use any platform technologies Controlled by Genmab, determine whether activities under each Manufacturing Transition Plan are completed as set out described in Clause 1.64, for the Development or Commercialisation of Licensed Product as contemplated in this AgreementSection 3.4 (Manufacturing Technology and Material Transfer); (8) discuss m) to decide matters and approve [***]; (9) discuss and approve [***] (10) appoint sub-committees as appropriate resolve disputes referred to facilitate coordination and cooperation between the Parties JSC which the JSC has authority to decide or otherwise to further the purposes of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development Committee, unless otherwise indicated in resolve under this Agreement; (13) discuss and approve any proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(A); and (15n) to perform such other functions as appropriate responsibilities specifically assigned to further the purposes of JSC pursuant to this Agreement or as determined may be mutually agreed upon by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment” means any change Parties in writing from time to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) months, and (iv) any other amendment which has any substantial effect on the timing, quality or costs of the activities thereby affected; and.

JSC Responsibilities. The JSC shall perform have the following functionsresponsibilities with respect to this Agreement: (1i) without prejudice to Clause 5.1(C)(3)monitor, at least [***] throughout review, discuss and coordinate the Term overall progress of this Agreement, review and discuss strategies and detailed plans (and progress against such plans) the Parties under the Joint Global Development Plan for the Development and Manufacture of Licensed Product in the Field and any Substantive Amendments (as defined below) to any such plansRusfertide and, as well applicable, any Joint Global Development Plans for Licensed Products other than Rusfertide, and the Joint Commercialization Plan for Rusfertide and, as a more high-level review and discussion of the Commercialisation Planapplicable, any Joint Commercialization Plans for Licensed Products other than Rusfertide; (2ii) review review, discuss and discuss determine whether to approve the high-level budgeted costs for Development and Manufacturing and actual spendings against such budgeted costs for each Calendar Quarteroccurrence of a Rusfertide Failure; (3iii) approve [***] provide a forum for, and facilitate communications between, the Development Plan, Manufacturing Plan and Technology Transfer Plan and (Parties with respect to the extent provided in this Agreement) any Commercialisation Plan for the subsequent Calendar Year, including budget and timelines, and subsequently during such Calendar Year approve any proposed Substantive Amendments to such plans; (4) discuss and approve any extension of any of the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Development Diligence Milestone as provided for in Clause 4.3(A)(4); (5) discuss and approve any proposal to Develop the [***] and the Development Plan for such [***]; (6) discuss and determine the need for any Third Party IPR licences, as provided for in Clause 6.8; (7) discuss and approve the need to use any platform technologies Controlled by Genmab, as set out in Clause 1.64, for the Development or Commercialisation of Licensed Product as contemplated in collaboration under this Agreement; (8) discuss iv) establish, but not delegate decision making authority to, such additional subcommittees as it deems necessary to achieve the objective and approve [***]; (9) discuss and approve [***] (10) appoint sub-committees as appropriate to facilitate coordination and cooperation between the Parties or otherwise to further the purposes intent of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development Committee, unless otherwise indicated in this Agreement; (13v) unless Protagonist has exercised the Rusfertide Opt-Out Right or a Partial Opt-Out Right (in which limited case the discontinuation shall apply solely with respect to the applicable Licensed Product that would be the subject of such plans and activities): ▇. ▇▇▇▇▇▇, discuss and determine whether to approve any proposed extension of amendment to (1) the Joint Global Development Committee Term; Plan for Rusfertide (14) review including, as applicable, the corresponding Shared Development Budget and approve associated regulatory strategy), including to add any Development Costs Clinical Trial or Indications as described in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(ASection ‎4.2(b); and (15) perform such other functions , as appropriate to further the purposes of this Agreement as determined recommended by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment” means any change to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) monthsJDC, and (iv2) the Joint Commercialization Plan for Rusfertide (including, as applicable, the corresponding Shared Commercialization Budget and associated distribution strategy) as recommended by the JCC, B.for any Licensed Product other amendment which has any substantial effect on than Rusfertide, as applicable, review, discuss and determine whether to approve its applicable Joint Global Development Plan (including the timingcorresponding Shared Development Budget and associated regulatory strategy) for such Licensed Product, quality or costs of and all annual and interim amendments thereto, as such plans and amendments may be submitted to the activities thereby affected; andJSC by the JDC as described in Section ‎4.2(a), ​

JSC Responsibilities. The In addition to its overall responsibility for monitoring and providing a forum to discuss each Party’s activities under this Agreement, including those that are subject to the Development cost-sharing arrangements described in Article 3, the JSC shall perform the following functionsin particular: (1i) without prejudice facilitate the flow of Information between the Parties with respect to Clause 5.1(C)(3), at least [***] throughout the Term co-Commercialization of this Agreement, review Compounds and discuss strategies and detailed plans (and progress against such plans) for the Development and Manufacture of Licensed Product in the Field and any Substantive Amendments (as defined below) to any such plans, as well as a more high-level review and discussion of the Commercialisation PlanProducts; (2ii) review and discuss the high-level budgeted costs for Development and progress of Development, Manufacturing and actual spendings against such budgeted costs for each Calendar Quarterco-Commercialization of Compounds and Products; (3iii) approve [***] coordinate activities of the Parties in connection with that portion of the Development Plan, Manufacturing Plan of Compounds and Technology Transfer Plan and (Products that are subject to the extent provided Development cost-sharing arrangements described in this Agreement) any Commercialisation Plan for the subsequent Calendar YearArticle 3, including budget and timelines, and subsequently during such Calendar Year approve with respect to any proposed Substantive Amendments to such plansinteractions with Regulatory Authorities; (4iv) discuss and if Development of R552 is discontinued, select a Lead Non-CNS Penetrant to replace R552; (v) review the Rxxx Data Package and, if applicable, approve any extension the selection of any of a RIP1 Inhibitor that meets the Development Diligence Milestone deadlines provided CNS Penetrant Criteria for in Clauses 4.3(A)(1designation as Rxxx pursuant to Section 3.4(a) and 4.3(A)(2), or any suspension of any Development Diligence Milestone as provided for in Clause 4.3(A)(4(CNS Penetrant Lead Identification); (5vi) discuss if applicable, review the Rxxx Continuation Data Package and approve any proposal the selection of a RIP1 Inhibitor that meets the CNS Penetrant Criteria for designation as Rxxx pursuant to Develop the [***] and the Development Plan for such [***]Section 3.4(b)(iv) (Rxxx Acceptance); (6vii) discuss review and determine provide feedback regarding proposed amendments of each Development Plan, including the need for any Third Party IPR licencesoverall strategy and design of all Clinical Trials and other studies conducted under each Development Plan, as provided for in Clause 6.8each case, to the extent such amendment relates to an activity that is, or such Clinical Trial is, subject to the Development cost-sharing arrangements described in Article 3; (7viii) approve amendments of the Non-CNS Penetrant Development Plan, including the R552 Development Plan, in each case to the extent such amendment relates to an activity under such plan that is subject to the Development cost-sharing arrangements described in Article 3; (ix) approve amendments of the CNS Penetrant Development Plan with respect to activities through the delivery to Lilly of the Rxxx Data Package and, if applicable in the case of Rigel Rxxx Continuation, the Rxxx Continuation Data Package; (x) review and provide feedback regarding such portions of the Commercialization Plan (and amendments thereto) that relate to co-Commercialization activities in the United States being undertaken by Rigel or Lilly; (xi) with respect to the Commercialization of Non-CNS Penetrant Products in the U.S. if Rigel has not delivered a Stage 1 Opt-Out Notice and has exercised its right to co-Commercialize the applicable Non-CNS Penetrant Product pursuant to Section 5.1 (Overview), oversee and coordinate activities of the Parties, discuss and review marketing studies, discuss pricing strategies (it being understood that Lilly will have sole decision making rights with respect to pricing and reimbursement matters), and review and approve the need to use any platform technologies Controlled by Genmabpromotional and training materials; (xii) establish such additional joint subcommittees or subteams, e.g., a joint commercialization committee (“JCC”), Joint Ethics and Compliance Committee (“JECC”) or a finance committee (“Finance Committee”), as set out in Clause 1.64, for it deems necessary to achieve the Development or Commercialisation objectives and intent of Licensed Product as contemplated in this Agreement; (8) discuss xiii) coordinate and approve [***];oversee the operation of the JDC, any JCC, the Finance Committee and any other Committee established by JSC, (9xiv) discuss and approve [***] (10) appoint sub-committees as appropriate resolve any issues presented to facilitate coordination and cooperation between the Parties or otherwise to further the purposes of this Agreement [***]; (11) discuss JSC by any dispute between the Parties as to whether a milestone payment has been triggered; (12) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development other Committee, unless otherwise indicated in this Agreement; (13) discuss and approve any proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(A); and (15xv) perform such other functions as appropriate to further the purposes of this Agreement as determined allocated to it in writing by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment” means any change to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) months, and (iv) any other amendment which has any substantial effect on the timing, quality or costs of the activities thereby affected; and.

JSC Responsibilities. The JSC shall perform the following functions: (1I) without prejudice review, coordinate and, in its discretion, approve the strategies for the Development, Commercialization and Manufacture of the Products in the Field in the Territory, and provide direction to Clause 5.1(C)(3)the DT, at least CT and ST as provided herein; (II) approve the scope of the DT's, CT's and ST's decision-making authority; (III) except as otherwise provided herein, review and, in its discretion, approve by [***] throughout the Term of this Agreement, review and discuss strategies and detailed plans (and progress against such plans) for each calendar year the Development and Manufacture of Licensed Product in the Field and any Substantive Amendments (as defined below) to any such plans, as well as a more high-level review and discussion of the Commercialisation Plan; (2) review and discuss the high-level budgeted costs for Development and Manufacturing and actual spendings against such budgeted costs for each Calendar Quarter; (3) approve [***] the Development Plan, Manufacturing Plan and Technology Transfer Plan and (to the extent provided in this Agreement) any Commercialisation Plan for the subsequent Calendar Year, calendar year (including the Development Plan annual budget and timelines, and subsequently during the division of responsibilities between the Parties under such Calendar Year approve any proposed Substantive Amendments to such plans;plan); ** CONFIDENTIAL TREATMENT REQUESTED (4IV) discuss and review and, in its discretion, approve any extension of any of substantive amendments to the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Plan (including the Development Diligence Milestone as provided for in Clause 4.3(A)(4Plan annual budget); (5V) discuss and review and, in its discretion, approve any proposal to Develop the multiyear long-range plan for Development of the Products in the Field in the Territory (including the budget for Development Costs) formulated by the DT; (VI) review and, in its discretion, approve recommendations for further Development of the Products, including Development of the Products for a New Indication; (VII) review and, in its discretion, approve by [***] and of each calendar year the Development Commercialization Plan for such [***]the subsequent calendar year (including the Commercialization Plan annual budget); (6VIII) discuss and determine review and, in its discretion, approve substantive amendments to the need for any Third Party IPR licences, as provided for in Clause 6.8Commercialization Plan (including the Commercialization Plan annual budget); (7IX) discuss and review and, in its discretion, approve the need to use any platform technologies Controlled multiyear long-range plan for Commercialization of the Products in the Field in the Territory (including the budget for Commercialization Costs) formulated by Genmab, as set out in Clause 1.64, for the Development or Commercialisation of Licensed Product as contemplated in this AgreementCT; (8) discuss X) review and, in its discretion, make a commercially reasonable determination whether the budget for Patent Costs prepared by the Patent Committee pursuant to Section 7.3 should be approved, and if appropriate, approve [***]the budget in accordance with such determination; (9) discuss and approve [***] (10) appoint sub-committees as appropriate to facilitate coordination and cooperation between the Parties or otherwise to further the purposes of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12XI) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development CommitteeDT, CT or ST, unless otherwise indicated in this Agreement; (13) discuss and approve any proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(A); and (15XII) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment” means any change to the Development Plan or the Manufacturing Plan other than a Non-Substantive Amendment, such as: (i) the addition to the Development Plan of any new Clinical Study, (ii) the deletion of any Clinical Study from the Development Plan, (iii) any amendment which is likely to result in a delay to any time-specific action forming part of the Development Plan or the Manufacturing Plan of more than six (6) months, and (iv) any other amendment which has any substantial effect on the timing, quality or costs of the activities thereby affected; and.