Common use of Joint Commercialization Plan Clause in Contracts

Joint Commercialization Plan. (i) No later than [**] prior to the anticipated first Regulatory Approval in the Shared Territory for a Licensed Product, the Parties shall, through the JCC, prepare and submit to the JSC for approval a detailed Commercialization plan for such Licensed Product in the Territory (the “Joint Commercialization Plan”), which shall include on a Calendar Year basis (with such Calendar Year plan segmented by Calendar Quarters within each Calendar Year) for [**], the pre-launch, launch and subsequent Commercialization of any Licensed Product in the Shared Territory, including First Commercial Sale preparation and pre-First Commercial Sale market development activities for such Licensed Product in the Field in the Shared Territory, Commercialization activities and the respective roles and responsibilities of each Party in connection with such activities, each Party’s sales forecasts, global pricing strategies, Manufacturing for Commercialization, key tactics and strategies for implementing those Commercialization activities, general marketing and promotional plans for such Product in the Shared Territory (including selection and prosecution of the Product Marks), the targeted level of promotion effort for each Licensed Product, including the number of Details, overall targeting strategy and approach for prescribers and organized customers (e.g., medical groups, integrated delivery networks, hospitals), for the Calendar Year(s) covered by the applicable Commercialization Plan, sales forces, use of Distributors, and the associated budget for the foregoing Commercialization activities for the remainder of [**] (the “Joint Commercialization Budget”) and a good faith forecast for the [**]. (ii) On an annual basis no later than [**] of each Calendar Year, or more often as the Parties deem appropriate, the JCC shall prepare amendments to the then-current Joint Commercialization Plan such that the forecasted profit and loss plan shall always reflect the forecasted profit and loss for the Licensed Products in the Shared Territory for the remainder of the then current Calendar Year and the next [**] Calendar Years, which amendments shall be finalized and approved by the JSC and included into the applicable Joint Commercialization Plan no later than [**] of each Calendar Year. The Joint Commercialization Plan shall allocate the responsibilities of the Parties for all Commercialization activities in the Shared Territory in an equitable manner. The Joint Commercialization Plan, including the corresponding Joint Commercialization Budget, with respect to the applicable Licensed Product in the Shared Territory and subsequent revisions thereto shall contain such information as the JCC and JSC believes necessary for the successful Commercialization of such Licensed Product in the Shared Territory, both pre- and post-launch. On a Calendar Year basis, or more often as the Parties deem appropriate, the JCC shall prepare and approve amendments to the then-current Joint Commercialization Plan, including the corresponding Joint Commercialization Budget. In the event of any inconsistency between a Joint Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Each Party shall conduct its activities under the Joint Commercialization Plan in compliance in all material respects with Applicable Law.

Joint Commercialization Plan. (ia) No later than [**] prior to As further described in this Section 6.2, the anticipated first Regulatory Approval tactics and strategy for the Commercialization of each Product in the Shared Territory for shall be described in a Licensed Productcomprehensive plan (each such plan, the Parties shall, through the JCC, prepare and submit to the JSC for approval a detailed Commercialization plan for such Licensed Product in the Territory (the “Joint Commercialization Plan”), which shall include on a Calendar Year basis (with such Calendar Year plan segmented by Calendar Quarters within each Calendar Year) for [**], that describes the pre-launch, launch and subsequent Commercialization of any Licensed such Product in the Shared TerritoryTerritory (including without limitation anticipated activities relating to messaging, including First Commercial Sale preparation branding, Pricing Matters, advertising, planning, marketing, sales force training and pre-First Commercial Sale market development activities for such Licensed Product in the Field in the Shared Territoryallocation, Commercialization activities and the respective roles and responsibilities of each Party in connection with such activities, each Party’s sales forecasts, global pricing strategies, Manufacturing for CommercializationDistribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a “Joint Commercialization activitiesBudget”). If Astellas believes any individual Commercialization Cost that it expects or plans to incur with respect to the Licensed Territory will also reasonably benefit the Shared Territory, general marketing Astellas may propose that a portion of such Commercialization Cost be allocated in the applicable Joint Commercialization Budget to the Shared Territory, and promotional plans Medivation shall consider that request reasonably and in good faith. No such Commercialization Cost may be allocated in whole or in part to the Shared Territory without the express written consent of Medivation (it being understood that each of the Parties shall be deemed to have consented expressly in writing that any such Commercialization Costs included as part of the Joint Commercialization Budget be allocated to the Shared Territory to the extent appearing in such budget). (b) Within [*] after the Effective Date, the Parties shall agree upon the initial Joint Commercialization Plan (including the initial Joint Commercialization Budget), following which the JCC shall approve such initial Joint Commercialization Plan. Subject to Section 6.5, each Joint Commercialization Plan shall allocate the responsibilities of the Parties for the activities under the plan in an equitable fashion taking into account the Parties’ respective capabilities and the Medivation Promotional Share elected by Medivation in accordance with Section 6.9 (it being understood that Medivation shall be assigned to perform that proportion of Details in the Joint Commercialization Plan that equals the Medivation Promotional Share). All Joint Commercialization Plans, including the corresponding Joint Commercialization Budgets, with respect to a 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 (including selection Territory, both pre- and prosecution of post-launch, and shall generally conform to the Product Marks), the targeted level of promotion effort for each Licensed Product, including the number detail utilized by Astellas in preparation of Details, overall targeting strategy and approach for prescribers and organized customers (e.g., medical groups, integrated delivery networks, hospitals), for the Calendar Year(s) covered by the applicable its own product Commercialization Plan, sales forces, use of Distributors, and the associated budget for the foregoing Commercialization activities for the remainder of [**] (the “Joint Commercialization Budget”) and a good faith forecast for the [**]. (ii) plans. On an annual basis (no later than [**] of each Calendar Yearthe preceding calendar year), or more often as the Parties deem appropriate, the JCC shall prepare amendments to the then-current Joint Commercialization Plan such that the forecasted profit and loss plan shall always reflect the forecasted profit and loss for the Licensed Products in the Shared Territory for the remainder of the then current Calendar Year and the next [**] Calendar Years, which amendments shall be finalized and approved by the JSC and included into the applicable Joint Commercialization Plan no later than [**] of each Calendar Year. The Joint Commercialization Plan shall allocate the responsibilities of the Parties for all Commercialization activities in the Shared Territory in an equitable manner. The Joint Commercialization PlanPlan(s), including the corresponding Joint Commercialization Budget, with respect to the applicable Licensed Product in the Shared Territory and subsequent revisions thereto shall contain such information as the JCC and JSC believes necessary for the successful Commercialization of such Licensed Product in the Shared Territory, both pre- and post-launch. On a Calendar Year basis, or more often as the Parties deem appropriate, the JCC shall prepare and approve amendments to the then-current Joint Commercialization Plan, including the corresponding Joint Commercialization BudgetBudgets. In the event of any inconsistency between a Joint Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Each Party shall conduct its activities under the Joint Commercialization Plan in compliance in all material respects with Applicable Law. [*] = 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.

Joint Commercialization Plan. The JDC shall determine a target filing date of the BLA for the most advanced Licensed Product being Developed under this Agreement (i) the “Target BLA Filing Date”). No later than [***] prior to the anticipated first Regulatory Approval in the Shared Territory for of a Licensed Product, the Parties shall, through the JCC, prepare and submit to the JSC for approval a detailed Commercialization plan for such Licensed Product in the Profit-Sharing Territory, GSK will provide to the JCC a draft initial joint commercialization plan and budget that sets out the Commercialization and Medical Affairs activities to be conducted by the Parties with respect to the Licensed Products in the Profit-Sharing Territory (the “Joint Commercialization Plan”), which shall include on a Calendar Year basis (. The Joint Commercialization Plan will be based upon and consistent with such Calendar Year plan segmented by Calendar Quarters within each Calendar Year) the Global Strategic Launch Plan for [**]the applicable Licensed Product. Promptly thereafter, the pre-launchJCC, with the support and direct involvement of the Financial Working Group with regard to preparation of the Joint Commercialization Budget, will review, discuss and recommend modifications to the draft Joint Commercialization Plan (provided, that only the medical representatives on the JCC may recommend modifications to the Medical Affairs activities set forth in the Joint Commercialization Plan), and the JCC will, in turn, provide such Joint Commercialization Plan (as such plan may be modified on the recommendation of the JCC) and Joint Commercialization Budget to the JSC to review, discuss and determine whether to approve. The Joint Commercialization Plan will (a) include matters similar to those included in the Global Strategic Launch Plan but revised to specifically support launch and subsequent Commercialization of any the Licensed Product in the Shared Profit-Sharing Territory, including First (b) [***] included in such plan to be undertaken for the upcoming Calendar Year which budget will be broken down by Calendar Quarter, for the estimated Commercial Sale preparation FTE Costs (for Commercialization activities), estimated Development FTE Costs (for Medical Affairs activities), Manufacturing Costs, and preOut-First Commercial Sale market development activities for such Licensed Product in the Field in the Shared Territory, Commercialization activities and the respective roles and responsibilities of Of-Pocket Costs expected to be incurred by each Party in connection the given Calendar Year with respect to such activities, each Party’s sales forecasts, global pricing strategies, Manufacturing for Commercialization, key tactics Medical Affairs and strategies for implementing those Commercialization activities, general marketing and promotional plans for such Product in the Shared Territory (including selection and prosecution of the Product Marks), the targeted level of promotion effort for each Licensed Product, including the number of Details, overall targeting strategy and approach for prescribers and organized customers (e.g., medical groups, integrated delivery networks, hospitals), for the Calendar Year(s) covered by the applicable Commercialization Plan, sales forces, use of Distributors, and the associated budget for the foregoing Commercialization activities for the remainder of [**] set forth in such plan (such budget the “Joint Commercialization Budget”) and a good faith forecast for the [**]. (ii) On an annual basis no later than [**] of each Calendar Year, or more often ). So long as the Parties deem appropriate, the JCC shall prepare amendments to the then-current Joint Commercialization Plan such that the forecasted profit and loss plan shall always reflect the forecasted profit and loss for ITEOS is Commercializing with GSK the Licensed Products in the Shared Profit-Sharing Territory for under this Agreement, on at least an annual basis during the remainder of the then current Calendar Year Term (or more frequently as may be required), GSK will review and the next [**] Calendar Years, which amendments shall be finalized and approved by the JSC and included into the applicable update each Joint Commercialization Plan no later than [**] (and Joint Commercialization Budget therein) based on the currently available information and data. GSK will provide to the JCC a copy of each Calendar Year. The such update to the Joint Commercialization Plan shall allocate to (together with the responsibilities of Financial Working Group) review, discuss, and recommend modifications (provided, that only the Parties for all Commercialization medical representatives on the JCC may recommend modifications to the Medical Affairs activities set forth in the Shared Territory in an equitable manner. The Joint Commercialization Plan), including and the corresponding JCC will, in turn, provide such update to the Joint Commercialization Plan (as such update may be modified on the recommendation of the JCC) to the JSC to review, discuss and determine whether to approve. The initial Joint Commercialization Plan and each such update to the Joint Commercialization Plan will become effective and will supersede the previous Joint Commercialization Plan only upon approval thereof by the JSC. Any such updates or amendments to the Joint Commercialization Plan and Joint Commercialization Budget may be memorialized in the JCC and JSC meeting minutes until the next annual update to the Joint Commercialization Plan and Joint Commercialization Budget, with respect at which time such updates or amendments will be added to the applicable Licensed Product in the Shared Territory and subsequent revisions thereto shall contain such information as the JCC and JSC believes necessary for the successful Commercialization of such Licensed Product in the Shared Territory, both pre- and post-launch. On a Calendar Year basis, or more often as the Parties deem appropriate, the JCC shall prepare and approve amendments to the then-current Joint Commercialization Plan, including the corresponding Joint Commercialization Budget. In the event of any inconsistency between a updated Joint Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Each Party shall conduct its activities under the Joint Commercialization Plan in compliance in all material respects with Applicable LawBudget.

Joint Commercialization Plan. (ia) No later than [**] prior to As further described in this Section 6.2, the anticipated first Regulatory Approval tactics and strategy for the Commercialization of each Product in the Shared Territory for shall be described in a Licensed Productcomprehensive plan (each such plan, the Parties shall, through the JCC, prepare and submit to the JSC for approval a detailed Commercialization plan for such Licensed Product in the Territory (the “Joint Commercialization Plan”), which shall include on a Calendar Year basis (with such Calendar Year plan segmented by Calendar Quarters within each Calendar Year) for [**], that describes the pre-launch, launch and subsequent Commercialization of any Licensed such Product in the Shared TerritoryTerritory (including without limitation anticipated activities relating to messaging, including First Commercial Sale preparation branding, Pricing Matters, advertising, planning, marketing, sales force training and pre-First Commercial Sale market development activities for such Licensed Product in the Field in the Shared Territoryallocation, Commercialization activities and the respective roles and responsibilities of each Party in connection with such activities, each Party’s sales forecasts, global pricing strategies, Manufacturing for CommercializationDistribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a “Joint Commercialization activitiesBudget”). If Astellas believes any individual Commercialization Cost that it expects or plans to incur with respect to the Licensed Territory will also reasonably benefit the Shared Territory, general marketing Astellas may propose that a portion of such Commercialization Cost be allocated in the applicable Joint Commercialization Budget to the Shared Territory, and promotional plans Medivation shall consider that request reasonably and in good faith. No such Commercialization Cost may be allocated in whole or in [*] = 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. part to the Shared Territory without the express written consent of Medivation (it being understood that each of the Parties shall be deemed to have consented expressly in writing that any such Commercialization Costs included as part of the Joint Commercialization Budget be allocated to the Shared Territory to the extent appearing in such budget). (b) Within [*] after the Effective Date, the Parties shall agree upon the initial Joint Commercialization Plan (including the initial Joint Commercialization Budget), following which the JCC shall approve such initial Joint Commercialization Plan. Subject to Section 6.5, each Joint Commercialization Plan shall allocate the responsibilities of the Parties for the activities under the plan in an equitable fashion taking into account the Parties’ respective capabilities and the Medivation Promotional Share elected by Medivation in accordance with Section 6.9 (it being understood that Medivation shall be assigned to perform that proportion of Details in the Joint Commercialization Plan that equals the Medivation Promotional Share). All Joint Commercialization Plans, including the corresponding Joint Commercialization Budgets, with respect to a 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 (including selection Territory, both pre- and prosecution of post-launch, and shall generally conform to the Product Marks), the targeted level of promotion effort for each Licensed Product, including the number detail utilized by Astellas in preparation of Details, overall targeting strategy and approach for prescribers and organized customers (e.g., medical groups, integrated delivery networks, hospitals), for the Calendar Year(s) covered by the applicable its own product Commercialization Plan, sales forces, use of Distributors, and the associated budget for the foregoing Commercialization activities for the remainder of [**] (the “Joint Commercialization Budget”) and a good faith forecast for the [**]. (ii) plans. On an annual basis (no later than [**] of each Calendar Yearthe preceding calendar year), or more often as the Parties deem appropriate, the JCC shall prepare amendments to the then-current Joint Commercialization Plan such that the forecasted profit and loss plan shall always reflect the forecasted profit and loss for the Licensed Products in the Shared Territory for the remainder of the then current Calendar Year and the next [**] Calendar Years, which amendments shall be finalized and approved by the JSC and included into the applicable Joint Commercialization Plan no later than [**] of each Calendar Year. The Joint Commercialization Plan shall allocate the responsibilities of the Parties for all Commercialization activities in the Shared Territory in an equitable manner. The Joint Commercialization PlanPlan(s), including the corresponding Joint Commercialization Budget, with respect to the applicable Licensed Product in the Shared Territory and subsequent revisions thereto shall contain such information as the JCC and JSC believes necessary for the successful Commercialization of such Licensed Product in the Shared Territory, both pre- and post-launch. On a Calendar Year basis, or more often as the Parties deem appropriate, the JCC shall prepare and approve amendments to the then-current Joint Commercialization Plan, including the corresponding Joint Commercialization BudgetBudgets. In the event of any inconsistency between a Joint Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Each Party shall conduct its activities under the Joint Commercialization Plan in compliance in all material respects with Applicable Law.

Joint Commercialization Plan. (i) No later than [**] prior to the anticipated first Regulatory Approval The Parties shall agree on a comprehensive joint product plan for Licensed Products in the Shared Territory for a Licensed Product, the Parties shall, through the JCC, prepare and submit to the JSC for approval a detailed Commercialization plan for such Licensed Product in the Territory (the “Joint Commercialization Plan”), which shall include on a Calendar Year basis (with such Calendar Year plan segmented by Calendar Quarters within each Calendar Year) for [**], the pre-launch, launch and subsequent Commercialization of any Licensed Product in the Shared Territory, including First Commercial Sale preparation and pre-First Commercial Sale market development activities for such Licensed Product in the Field in the Shared Territory, Commercialization activities and the respective roles and responsibilities of each Party in connection with such activities, each Party’s sales forecasts, global pricing strategies, Manufacturing for Commercialization, key tactics and strategies for implementing those Commercialization activities, general marketing and promotional plans for such Product in the Shared Territory (including selection and prosecution of the Product Marks), the targeted level of promotion effort for each Licensed Product, including the number of Details, overall targeting strategy and approach for prescribers and organized customers (e.g., medical groups, integrated delivery networks, hospitals), for the Calendar Year(s) covered by the applicable Commercialization Plan, sales forces, use of Distributors, and the associated budget for the foregoing Commercialization activities for the remainder of [**] (the the, “Joint Commercialization Budget”) and a good faith forecast for ). Notwithstanding the foregoing, the initial Joint Commercialization Plan (including the initial high-level Joint Commercialization Budget [***].), which includes a forecasted profit and loss plan [***] based on initial product plan activities for the Lead Product during such period, is attached hereto as Exhibit H. ​ ​ ​ (ii) On an annual basis no later than [***] of each Calendar Year, or more often as the Parties deem appropriate, the JCC shall prepare amendments to the then-current Joint Commercialization Plan such that the forecasted profit and loss plan shall always reflect the forecasted profit and loss for the Licensed Products in the Shared Territory for the remainder of the then current Calendar Year and the next [**] Calendar Years*], which amendments shall be finalized and approved by the JSC JCC and included into the applicable Joint Commercialization Plan no later than [***] of each Calendar Year. The Joint Commercialization Plan shall allocate the responsibilities of the Parties for all Commercialization activities in the Shared Territory in an equitable mannermanner that optimizes the value of the Licensed Products in the Shared Territory. The Joint Commercialization Plan, including the corresponding Joint Commercialization Budget, with respect to the applicable Licensed Product Products in the Shared Territory and subsequent revisions thereto shall contain such information as the JCC and JSC believes necessary for the successful Commercialization of such the Licensed Product Products in the Shared Territory, both pre- and post-launch. On a Calendar Year basis, or more often as the Parties deem appropriate, the JCC shall prepare and approve amendments to the then-current Joint Commercialization Plan, including the corresponding Joint Commercialization Budget. In the event of any inconsistency between a Joint Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Each Party shall conduct its activities under the Joint Commercialization Plan in compliance in all material respects with Applicable Law. For the avoidance of doubt, any costs incurred by a Party for any Commercialization activity that are not set forth in the then-current Joint Commercialization Budget or are incurred for any Commercialization activity not included in the then-current Joint Commercialization Plan are not Joint Operational Costs and shall not be subject to reconciliation pursuant to this Section 5.4 and shall be borne entirely by the Party that incurs them.