Common use of Commercialization Plans Clause in Contracts

Commercialization Plans. As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

Commercialization Plans. As soon as practicable after formation [****] Zai will develop and provide an initial draft of the JCC Commercialization Plan for such Licensed Product to the JPT for its review and discussion. The Commercialization Plan for a Licensed Product will contain [****] Commercialization activities to be undertaken (following Acucela’s exercise including [****]) for such Licensed Product in the Territory and the estimated timelines for achieving such activities. The JPT will have the right to comment on each such Commercialization Plan and Zai will consider such comments [****] and incorporate such comments [****] prior to finalizing each such Commercialization Plan. Thereafter, from time to time, [****] Zai will propose updates to the Commercialization Plan for each Licensed Product in consultation with the JPT to reflect changes in such plans, including those in response to changes in the marketplace, relative commercial success of an Opt-In Right under Section 3.1)the applicable Licensed Product, and other relevant factors that may influence such plan and the JCC shall prepare Commercialization activities set forth therein. Zai will submit each proposed updated Commercialization Plan for a Licensed Product to the JPT for review and discussion and will consider [****] and incorporate [****] any comments thereon provided by the JPT before finalizing any such update. Zai submit each initial Commercialization Plan and each such proposed updated Commercialization Plan to the JSC. The JSC will review, discuss, and determine whether to approve the each initial Commercialization Plan for Commercialization of the each Licensed Product for and each update thereto. Once approved by the Initial Indication in the Initial Formulation (andJSC, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts each update to ensure that such initial a Commercialization Plan for Commercialization of the a Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto will become effective and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by supersede the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plansuch Licensed Product. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the for a Licensed Product (includingincluding each update thereto) must be consistent with Blueprint’s global brand strategy and global key messaging, and Global Brand Elements for such Licensed Product (each, a “Global Brand Strategy”), if applicableand as provided to Zai by Blueprint from time to time during the Term; provided, however, that if the JSC agrees upon brand strategy for a Licensed Product that is specific to the Territory (or any Other Indication Productregion therein) and that is inconsistent with the Global Brand Strategy for such Licensed Product (including any product positioning or messaging for the Territory or any region therein), including:then Zai will have the right to implement such Territory-specific brand strategy within the Territory and to incorporate such inconsistent strategies in the Commercialization Plan for such Licensed Product.

Commercialization Plans. As soon as practicable after formation [***] CStone will develop and provide an initial draft of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of such Collaboration Product to the Licensed Product JPT for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territoryits review and discussion. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for a Collaboration Product will contain a [***] the major Commercialization of the Licensed activities to be undertaken (including revenue targets) for such Collaboration Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and the estimated timelines for Commercialization of achieving such activities. The JPT will have the right to comment on each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each such Commercialization Plan not less than annually or more frequently as needed and CStone will consider such comments [***] and incorporate such comments [***] prior to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current finalizing each such Commercialization Plan. Amendments and revisions Thereafter, from time to time[***] CStone will propose updates to the Commercialization Plan shall be reviewed for each Collaboration Product in consultation with the JPT to reflect changes in such plans, including those in response to changes in the marketplace, relative commercial success of the applicable Collaboration Product, and discussed, in advance, other relevant factors that may influence such plan and the Commercialization activities set forth therein. CStone will submit each proposed updated Commercialization Plan for a Collaboration Product to the JPT for review and discussion and will consider [***] and incorporate [***] any comments thereon provided by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for JPT before adopting any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plansuch update. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization for a Collaboration Product (including Co-Promotioneach update thereto) activities related must be consistent with Blueprint’s global brand strategy and global key messaging for such Collaboration Product (each, a “Global Brand Strategy”), if and as provided to CStone by Blueprint from time to time during the Term; provided, however, that if the JSC agrees upon brand strategy for a Collaboration Product that is specific to the Licensed Territory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Collaboration Product (including, if applicable, including any Other Indication Productproduct positioning or messaging for the Territory or any region therein), including:then CStone will have the right to implement such Territory-specific brand strategy within the Territory and to incorporate such inconsistent strategies in the Commercialization Plan for such Collaboration Product.

Commercialization Plans. As soon as practicable after formation of With respect to both the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1)E2609 Eisai Collaboration Product and the BAN2401 Eisai Collaboration Product, the JCC shall prepare a comprehensive rolling, three (3)-Calendar Year plan with the tactics and strategy for the Commercialization of Eisai Collaboration Products in each Commercial Territory (including for each Major Commercialization Country) and shall update each such plan annually as set forth in Section 7.6(a) (each such plan, a “Commercialization Plan”). Unless otherwise agreed to by the Parties, each Commercialization Plan and any updates thereto shall (x) reflect the application of Commercially Reasonable Efforts to Commercialize Eisai Collaboration Products either globally or in the applicable Commercial Territory, (y) implement the Global Branding Strategy for the Eisai Collaboration Products and (z) describe in detail the pre-launch, launch and subsequent Commercialization of Eisai Collaboration Products either globally or in the applicable Commercial Territory, including the following components: (1) overall goals of the Parties with regard to the Commercialization of Eisai Collaboration Products; (2) anticipated activities relating to messaging, branding, marketing and training with respect to Eisai Collaboration Products; and (3) key tactics and strategies with respect to Eisai Collaboration Products. Each Commercialization Plan shall allocate the responsibilities of the Parties for the activities under plan in an equitable fashion taking into account the Parties’ respective capabilities, provide a meaningful role for each Party and be consistent with the co-promotion terms set forth on Exhibit 5.3(a). With respect to (A) each Commercial Territory that is not a Major Commercialization Country, the JSC shall approve the initial Commercialization Plan for Commercialization at least one hundred eighty (180) days prior to the anticipated First Commercial Sale of the Licensed an Eisai Collaboration Product for the Initial Indication anywhere in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Commercial Territory, and (B) each Major Commercialization Country, the JSC shall update and amend each approve the Initial Commercialization Plan not less than annually or more frequently as needed at least ten (10) months prior to take into account changed circumstances or completionthe anticipated First Commercial Sale of an Eisai Collaboration Product anywhere in such Major Commercialization Country. In the event 132539616_1 of any inconsistency between a Commercialization Plan and this Agreement, commencement or cessation the terms of Commercialization activities not contemplated this Agreement shall prevail unless otherwise mutually agreed by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:Parties.

Commercialization Plans. As soon as practicable after formation Incyte shall conduct its Commercialization activities with respect to any Profit-Share Product under a rolling three (3) year commercialization plan and associated budget (each, a “Commercialization Plan”) that will describe the proposed overall program of Commercialization of such Product in the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the Field. An initial Commercialization Plan for Commercialization each Profit-Share Product shall be prepared no later than the earlier of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization Initiation of the Licensed second Phase 2 Clinical Trial of such Product for or the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version Initiation of the Commercialization Plan, or that provides for addition or discontinuation first Phase 3 Clinical Trial of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plansuch Product. Each Commercialization Plan shall identify be updated annually by Incyte, in consultation with Agenus, and submitted to the goals JSC for review and approval not later than October 31 of each Calendar Year during the Term. Each such updated Commercialization contemplated thereunder Plan shall include (i) an overall Commercialization plan for the applicable Profit-Share Product that sets forth all major Commercialization tasks remaining to be accomplished prior to First Commercial Sale, (ii) a detailed description for the Commercialization activities proposed for the following three (3) Calendar Years, and (iii) a detailed, rolling three (3) year financial forecast containing a good faith estimated revenue forecast and a committed budget for the first Calendar Year and good faith estimates of the [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. CONFIDENTIAL TREATMENT MATERIAL budget for the following two (2) Calendar Years. While minor adjustments to the Commercialization Plan may be made from time to time in Incyte’s discretion, any changes in budgeted funding exceeding [**] of the then-total amount budgeted in any Calendar Year for such Profit-Share Product must be approved by the JSC, in the absence of which approval the most recently approved Commercialization Plan and budget shall address Commercialization remain in effect. Notwithstanding the foregoing, if the JSC does not approve the budget increase, and (including 1) such increase is for an activity to be conducted by Agenus for a Co-PromotionPromotion Product, Incyte may, in its sole discretion, fund such activity and such expenditure shall be an Allowable Expense hereunder, or (2) activities related subject to the Licensed Product clause (including, if applicable, any Other Indication Product1), including:Incyte may fund such amounts itself, and such expenditures shall not be an Allowable Expense hereunder.