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: (i) strategies for positioning and marketing of the Licensed Product in the Field in the Territory; (ii) designation of which Party will be the Responsible Party with respect to specific Commercialization activities; (iii) the personnel, Detailing and other resources to be devoted by each Party to the Co-Promotion efforts, including the budgeted number of sales representatives, managed market representatives and medical affairs personnel, assignment of Detailing responsibilities by market segment, including the minimum number and positioning of Details (which, with respect to Acucela shall be consistent with the Participation Percentage), the target healthcare professionals, and the type and level of other sales force activities to be performed by each Party; provided that such resources and efforts shall be comparable to the activities actually conducted in connection with promotion of other pharmaceutical products then marketed in the Field in the Territory; (iv) the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any, which shall be set forth in a Development Plan) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any) after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Commercialization Plan; (v) requirements for programs (including medical education programs) and grants related to the Licensed Product, such as speaker programs, lunch programs, congresses, symposia, speaker and peer-to-peer activity programs, publication plans and medical information plans; (vi) Phase 3b Clinical Trials and Post-Approval Studies, if any; (vii) public relations and communications programs; (viii) nature of Co-Promotion activities and call plans (including allocation of key decision makers and Co-Promotion to managed care providers); and (ix) marketing research plans and metrics for measuring the success of the respective Parties’ efforts in respect of Commercialization of the Licensed Product in the Field in the Territory.
Appears in 2 contracts
Samples: Development and Collaboration Agreement (Acucela Inc), Development and Collaboration Agreement (Acucela Inc)
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:
(i) strategies for positioning and marketing of the Licensed Product in the Field in the Territory;
(ii) designation of which Party will be the Responsible Party with respect to specific Commercialization activities;
(iii) the personnel, Detailing and other resources to be devoted by each Party to the Co-Promotion efforts, including the budgeted number of sales representatives, managed market representatives and medical affairs personnel, assignment of Detailing responsibilities by market segment, including the minimum number and positioning of Details (which, with respect to Acucela shall be consistent with the Participation Percentage), the target healthcare professionals, and the type and level of other sales force activities to be performed by each Party; provided that such resources and efforts shall be comparable to the activities actually conducted in connection with promotion of other pharmaceutical products then marketed in the Field in the Territory;
(iv) the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any, which shall be set forth in a Development Plan) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any) after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Commercialization Plan;
(v) requirements for programs (including medical education programs) and grants related to the Licensed Product, such as speaker programs, lunch programs, congresses, symposia, speaker and peer-to-peer activity programs, publication plans and medical information plans;
(vi) Phase 3b Clinical Trials and Post-Approval Studies, if any;
(vii) public relations and communications programs;
(viii) nature of Co-Promotion activities and call plans (including allocation of key decision makers and Co-Promotion to managed care providers); and
(ix) marketing research plans and metrics for measuring the success of the respective Parties’ efforts in respect of Commercialization of the Licensed Product in the Field in the Territory.
Appears in 1 contract
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:
(i) strategies for positioning and marketing of the Licensed Product in the Field in the Territory;
(ii) designation of which Party will be the Responsible Party with respect to specific Commercialization activities;
(iii) the personnel, Detailing and other resources to be devoted by each Party to the Co-Promotion efforts, including the budgeted number of sales representatives, managed market representatives and medical affairs personnel, assignment of Detailing responsibilities by market segment, including the minimum number and positioning of Details (which, with respect to Acucela shall be consistent with the Participation Percentage), the target healthcare professionals, and the type and level of other sales force activities to be performed by each Party; provided that such resources and efforts shall be comparable to the activities actually conducted in connection with promotion of other pharmaceutical products then marketed in the Field in the Territory;
(iv) the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any, which shall be set forth in a Development Plan) for the forthcoming calendar year (or portion thereof), including a reasonably detailed allocation of such costs and expenses among the activities expected to be conducted in such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any) after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected in the Commercialization Plan;
(v) requirements for programs (including medical education programs) and grants related to the Licensed Product, such as speaker programs, lunch programs, congresses, symposia, speaker and peer-to-peer activity programs, publication plans and medical information plans;
(vi) Phase 3b Clinical Trials and Post-Approval Studies, if any;
(vii) public relations and communications programs;
(viii) nature of Co-Promotion activities and call plans (including allocation of key decision makers and Co-Promotion to managed care providers); and
(ix) marketing research plans and metrics for measuring the success of the respective Parties’ efforts in respect of Commercialization of the Licensed Product in the Field in the Territory.. 37
Appears in 1 contract
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 to the Licensed Product (including, if applicable, any Other Indication Product), including:
(i) strategies for positioning and marketing of the Licensed Product in the Field in the Territory;
(ii) designation of which Party will be the Responsible Party with respect to specific Commercialization activities;
(iii) the personnel, Detailing and other resources to be devoted by each Party to the Co-Promotion efforts, including the budgeted number of sales representatives, managed market representatives and medical affairs personnel, assignment of Detailing responsibilities by market segment, including the minimum number and positioning of Details (which, with respect to Acucela shall must be consistent with the Participation PercentageBlueprint’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 target healthcare professionalsTerm; provided, and however, that if the type and level of other sales force activities to be performed by each Party; provided JSC agrees upon brand strategy for a Collaboration Product that such resources and efforts shall be comparable is specific to the activities actually conducted in connection Territory (or any region therein) and that is inconsistent with promotion of other pharmaceutical products then marketed in the Field in the Territory;
Global Brand Strategy for such Collaboration Product (iv) the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any, which shall be set forth in a Development Plan) including any product positioning or messaging for the forthcoming calendar year (Territory or portion thereofany region therein), including a reasonably detailed allocation of then CStone will have the right to implement such costs Territory-specific brand strategy within the Territory and expenses among the activities expected to be conducted in incorporate such calendar year (or portion thereof), and a reasonable good faith projection of the budget for Commercialization Costs (excluding costs of Phase 4 Clinical Trials, if any) after such calendar year, in each case which budget shall be an amount reasonably intended to be sufficient to cover the anticipated costs associated with the activities reflected inconsistent strategies in the Commercialization Plan;
(v) requirements Plan for programs (including medical education programs) and grants related to the Licensed such Collaboration Product, such as speaker programs, lunch programs, congresses, symposia, speaker and peer-to-peer activity programs, publication plans and medical information plans;
(vi) Phase 3b Clinical Trials and Post-Approval Studies, if any;
(vii) public relations and communications programs;
(viii) nature of Co-Promotion activities and call plans (including allocation of key decision makers and Co-Promotion to managed care providers); and
(ix) marketing research plans and metrics for measuring the success of the respective Parties’ efforts in respect of Commercialization of the Licensed Product in the Field in the Territory.
Appears in 1 contract
Samples: License and Collaboration Agreement (Blueprint Medicines Corp)
