Common use of Joint Commercialization Plan Clause in Contracts

Joint Commercialization Plan. At an appropriate time to be mutually agreed by the Parties through the JMC (but in any event [**] months prior to commercial launch of the applicable Shared Product in the United States), the Parties through the JMC shall mutually agree upon the initial joint plan for Commercialization of such Shared Product for the U.S. (the “Joint Commercialization Plan”), with the goal that each Party’s participation in the Commercialization of Shared Product for the U.S. shall, to the extent practicable, be substantially equal on an ongoing basis, provided that a Party shall not be assigned a particular Commercialization activity or responsibility unless it has the capacity and capability to undertake such activity or responsibility, as determined by the JMC. The Joint Commercialization Plan may be amended or updated from time to time by mutual agreement of the Parties through the JMC, including any amendments or updates to any anticipated timelines or to the then-current budget. The Joint Commercialization Plan shall encompass the planned Commercialization strategy in the U.S. for the applicable Shared Product and shall set forth the corresponding budget of Shared Commercialization Costs, anticipated timelines, Commercialization activities to be performed by each Party, commercial supply forecasts, and the other matters described below. The initial Joint Commercialization Plan shall include the budgeted Shared Commercialization Costs for pre-launch Commercialization activities in the U.S. and for Commercialization activities through at least [**] Calendar Years after the First Commercial Sale of the Shared Product in the U.S. Thereafter, the Joint Commercialization Plan shall be updated by the Parties, through the JMC, on an [**] basis. The Joint Commercialization Plan shall contain at a minimum, solely in regards to the U.S., the following (unless otherwise mutually agreed by the Parties): (1) wholesale acquisition cost (“WAC”) pricing strategy, publication strategy (with the Parties to agree on roles and responsibilities), market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Shared Product positioning; (2) sales forecast for the next [**] Calendar Years; (3) medical education plan which shall set forth medical science liaison (“MSL”) and medical affairs strategies and activities, including meetings with key opinion leaders, consultancy meetings or programs, non-promotional activities, conferences, budgets and strategies for grant disbursements, medical information services, managing relationships with cooperative groups, and establishing and implementing risk, evaluation and mitigation strategies. (4) advertising and promotion programs and strategies, including sales literature, promotional premiums, media plans, symposia and speaker programs; (5) sales plans and activity, including sales force training, and for each Party, development of appropriate sales training materials, and strategy and budget for samples; (6) post-marketing studies not required to obtain or maintain Regulatory Approvals to be conducted; (7) the total Details required to support the Shared Product, the responsibility for which Details shall be allocated 50/50 between the Parties (unless otherwise mutually agreed by the Parties), and the number of Sales Representatives and Details to be provided by each Party in such period; (8) the number of MSLs and medical affairs personnel and allocation between the Parties of MSL and medical affairs coverage for the United States, the responsibility for which MSLs and medical affairs coverage shall be allocated 50/50 between the Parties (unless otherwise mutually agreed by the Parties), with the goal of having each Party participate on a meaningful basis in such activities; (9) the Party(ies) that is responsible for each Commercialization activity; provided that, unless otherwise agreed by the Parties, the Parties shall jointly plan and participate in, and EISAI shall be solely responsible for administering, activities under the medical education plan with respect to meetings with key opinion leaders, consultancy meetings or programs, conferences, grant disbursements, and medical information services (including responding to physician inquiries).

Joint Commercialization Plan. At an appropriate time to be mutually agreed by (i) As further described in this Section 8.3, the Parties through tactics and strategy for the JMC (but in any event [**] months prior to commercial launch Commercialization of the applicable Shared each Product in the United States)Territory will be described in a comprehensive plan (each such plan, the Parties through the JMC shall mutually agree upon the initial joint plan for Commercialization of such Shared Product for the U.S. (the a “Joint Commercialization Plan”)) that describes the pre-launch, with the goal that each Party’s participation launch and subsequent Commercialization of such Product in the Commercialization of Shared Product for the U.S. shallTerritory (including anticipated activities relating to messaging, branding, Pricing Matters (to the extent practicablenot prohibited by Applicable Law), be substantially equal advertising, planning, marketing, sales force training and allocation, detailing, and Distribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a “Joint Commercialization Budget”). (ii) Either Party’s representatives on an ongoing basisthe JCC may propose a Voluntary Phase 4 Clinical Trial. If the JCC does not recommend such Voluntary Phase 4 Clinical Trial to the JSC (or the JSC does not approve it) for inclusion in the Joint Commercialization Plan, provided that a the proposing Party shall will have the right to conduct such Voluntary Phase 4 Clinical Trial, at its sole expense, even if not be assigned a particular Commercialization activity or responsibility unless it has included in the capacity and capability to undertake such activity or responsibility, as determined by the JMC. The Joint Commercialization Plan by the JSC, unless the other Party reasonably believes that any such Voluntary Phase 4 Clinical Trial would present unreasonable safety risk or would materially harm the commercial potential of the Product or, in the case of Unum, may result in an ACTR Matter. Each Party will notify the other Party, and provide such information as the other Party may request, regarding any proposed Voluntary Phase 4 Clinical Trial before taking any steps to initiate same. (iii) If SGI reasonably believes that a Voluntary Phase 4 Clinical Trial that SGI is conducting at its sole expense for the Licensed Territory will also reasonably benefit the Shared Territory, SGI may propose to Unum that a portion or all of the costs attributable to such Voluntary Phase 4 Clinical Trial be included in the [***] allocation set forth in Section 8.3(b), and Unum will consider that request reasonably and in good faith. Alternatively, Unum may request by written notice to SGI that any Voluntary Phase 4 Clinical Trial that SGI is conducting at its sole expense pursuant to the preceding sentence be included in the Joint Commercialization Plan and the Joint Commercialization Costs attributable to such Voluntary Phase 4 Clinical Trial be allocated on the terms set forth in this Section 8.3(a)(iii), including the applicable premium. No such costs may be amended allocated in whole or updated from time in part without the express written consent of Unum and for clarity will not be subject to time by mutual agreement decision within the JDC or JSC (it being understood that each of the Parties through will be deemed to have consented expressly in writing that any such costs included as part of the JMCJoint Commercialization Plan be so allocated to the extent appearing in such plan). Further, such an allocation of such costs incurred with respect to such Voluntary Phase 4 Clinical Trial may be made retrospectively (i.e., after the relevant activity has been performed); provided that if (a) the allocation is made after the acceptance in the Shared Territory of an application for Regulatory Approval that includes information or data generated by such Voluntary Phase 4 Clinical Trial but before Regulatory Approval is granted, Unum will, in addition to paying the share allocated to it for Development Costs already incurred in accordance with Section 8.3(b), pay to SGI a premium equal to [***] of Unum’s share of such amount allocated for incurred costs only and (b) the allocation is made after Regulatory Approval is granted, Unum will, in addition to paying the share allocated to it for Development Costs already incurred in accordance with Section 8.3(b), pay to SGI a premium equal to [***] of Unum’s share of the amount allocated for incurred costs only. For purposes of the immediately preceding sentence, the date of Unum’s request for allocation will be treated as the date on which such allocation is made. Notwithstanding the forgoing, Unum will not use information or data generated by such Voluntary Phase 4 Clinical Trial in the Shared Territory prior to agreement by the parties to include the data from such Voluntary Phase 4 Clinical Trial (unless such use is at the request of a Regulatory Authority or required by Applicable Law). (iv) If Unum reasonably believes that a Voluntary Phase 4 Clinical Trial that Unum is conducting at its sole expense for the Shared Territory will also reasonably benefit the Licensed Territory, Unum may propose to SGI that a portion or all of the Joint Commercialization Costs attributable to such Voluntary Phase 4 Clinical Trial be included in the [***] allocation set forth in Section 8.3(b), and SGI will consider that request reasonably and in good faith. Alternatively, SGI may request by written notice to Unum that any Voluntary Phase 4 Clinical Trial that Unum is conducting at its sole expense pursuant to the preceding sentence be included in the Joint Commercialization Plan and the Joint Commercialization Costs attributable to such Voluntary Phase 4 Clinical Trial be allocated on the terms set forth in this Section 8.3(a)(iv), including the applicable premium. No such Joint Commercialization Costs may be allocated in whole or in part without the express written consent of SGI and for clarity will not be subject to decision within the JDC or JSC (it being understood that each of the Parties will be deemed to have consented expressly in writing that any such Joint Commercialization Costs included as part of the applicable Joint Commercialization Plan be so allocated to the extent appearing in such plan). Further, such an allocation of such Joint Commercialization Costs incurred with respect to such Voluntary Phase 4 Clinical Trial may be made retrospectively (i.e., after the relevant activity has been performed); provided that if (a) the allocation is made after the acceptance in the Licensed Territory of an application for Regulatory Approval that includes information or data generated by such Voluntary Phase 4 Clinical Trial but before Regulatory Approval is granted, SGI will, in addition to paying the share allocated to it for Development Costs already incurred in accordance with Section 8.3(b), pay to Unum a premium equal to [***] of SGI’s share of such amount allocated for incurred costs only and (b) the allocation is made after Regulatory Approval is granted, SGI will, in addition to paying the share allocated to it for Development Costs already incurred in accordance with Section 8.3(b), pay to Unum a premium equal to [***] of SGI’s share of the amount allocated for incurred costs only. For purposes of the immediately preceding sentence, the date of SGI’s request for allocation will be treated as the date on which such allocation is made. Notwithstanding the forgoing, SGI will not use information or data generated by such Voluntary Phase 4 Clinical Trial in the Licensed Territory prior to agreement by the parties to include the data from such Voluntary Phase 4 Clinical Trial (unless such use is at the request of a Regulatory Authority or required by Applicable Law). (v) No later than [***] prior to the projected NDA filing date for a Product in the Shared Territory, the JCC will prepare and recommend to the JSC for approval an initial Joint Commercialization Plan for each Product (including the initial Joint Commercialization Budget). Subject to Section 8.3(c), each Joint Commercialization Plan will allocate the Co-Promotion responsibilities of the Parties in an equitable fashion taking into account the Parties’ respective capabilities. For clarity, SGI will be responsible for all Commercialization activities in the Licensed Territory, and such activities will not be included in the Joint Commercialization Plan. All Joint Commercialization Plans, including the corresponding Joint Commercialization Budgets, with respect to each Product in the Shared Territory and subsequent revisions thereto will contain such information as the JCC believes necessary for the successful Commercialization of such Product in the Shared Territory, both pre- and post-launch, and will generally conform to the level of detail utilized by the Lead Commercializing Party in preparation of its own product Commercialization plans. On an annual basis, or more often as the Parties deem appropriate, the JCC will prepare amendments or updates to any anticipated timelines or to the then-current budgetJoint Commercialization Plan(s), including the corresponding Joint Commercialization Budgets. The In the event of any inconsistency between a Joint Commercialization Plan shall encompass and this Agreement, the planned Commercialization strategy in the U.S. for the applicable Shared Product and shall set forth the corresponding budget terms of Shared Commercialization Costs, anticipated timelines, Commercialization this Agreement will prevail. Each Party will conduct its activities to be performed by each Party, commercial supply forecasts, and the other matters described below. The initial Joint Commercialization Plan shall include the budgeted Shared Commercialization Costs for pre-launch Commercialization activities in the U.S. and for Commercialization activities through at least [**] Calendar Years after the First Commercial Sale of the Shared Product in the U.S. Thereafter, under the Joint Commercialization Plan shall be updated by the Parties, through the JMC, on an [**] basis. The Joint Commercialization Plan shall contain at a minimum, solely Plan(s) in regards to the U.S., the following (unless otherwise mutually agreed by the Parties): (1) wholesale acquisition cost (“WAC”) pricing strategy, publication strategy (compliance in all material respects with the Parties to agree on roles and responsibilities), market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Shared Product positioning; (2) sales forecast for the next [**] Calendar Years; (3) medical education plan which shall set forth medical science liaison (“MSL”) and medical affairs strategies and activities, including meetings with key opinion leaders, consultancy meetings or programs, non-promotional activities, conferences, budgets and strategies for grant disbursements, medical information services, managing relationships with cooperative groups, and establishing and implementing risk, evaluation and mitigation strategiesApplicable Law. (4) advertising and promotion programs and strategies, including sales literature, promotional premiums, media plans, symposia and speaker programs; (5) sales plans and activity, including sales force training, and for each Party, development of appropriate sales training materials, and strategy and budget for samples; (6) post-marketing studies not required to obtain or maintain Regulatory Approvals to be conducted; (7) the total Details required to support the Shared Product, the responsibility for which Details shall be allocated 50/50 between the Parties (unless otherwise mutually agreed by the Parties), and the number of Sales Representatives and Details to be provided by each Party in such period; (8) the number of MSLs and medical affairs personnel and allocation between the Parties of MSL and medical affairs coverage for the United States, the responsibility for which MSLs and medical affairs coverage shall be allocated 50/50 between the Parties (unless otherwise mutually agreed by the Parties), with the goal of having each Party participate on a meaningful basis in such activities; (9) the Party(ies) that is responsible for each Commercialization activity; provided that, unless otherwise agreed by the Parties, the Parties shall jointly plan and participate in, and EISAI shall be solely responsible for administering, activities under the medical education plan with respect to meetings with key opinion leaders, consultancy meetings or programs, conferences, grant disbursements, and medical information services (including responding to physician inquiries).