Common use of Co-Commercialization Plan Clause in Contracts

Co-Commercialization Plan. At an appropriate time to be agreed by the JCC (but in any event [***] months prior to commercial launch of the applicable Co-Exploited Product in the United States), the JCC shall agree upon the initial joint plan and budget for Commercialization of such Co-Exploited Product for the United States (the “Co-Commercialization Plan”), with the goal that each Party’s participation in the Commercialization of Co-Exploited Product for the United States 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 or reasonably can, in a timely manner, obtain, create, or add the capacity and capability to undertake such activity or responsibility. The Co-Commercialization Plan may be amended or updated from time to time by the JCC, including any amendments or updates to any anticipated timelines or to the then-current budget. The Co-Commercialization Plan shall encompass the planned Commercialization strategy in the United States for the Co-Exploited 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 Co-Commercialization Plan shall include the budgeted Shared Commercialization Costs for pre-launch Commercialization activities in the United States and for Commercialization activities through at least [***] Calendar [***] after the First Commercial Sale of the Co-Exploited Product in the United States. Thereafter, the Co-Commercialization Plan shall be updated by the JCC on an annual basis. The Co-Commercialization Plan shall contain at a minimum, solely in regards to the United States, the following (unless otherwise mutually agreed by the Parties): i) wholesale acquisition cost (“WAC”) pricing strategy, market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Co-Exploited Product positioning; ii) sales forecast for the next [***] Calendar Years; iii) advertising and promotion programs and strategies, including sales literature, promotional materials, media plans, symposia and speaker programs; iv) sales plans and activities, including sales force training, development of appropriate sales training materials, and strategy and budget for samples; v) post-marketing studies not required to obtain or maintain Regulatory Approvals to be conducted; vi) the Detail Requirements required to support the Co-Exploited Product, the responsibility for which shall be allocated between the Parties by the JCC in an equitable manner, taking into consideration all reasonable factors; vii) plan for implementation of periodic joint sales and marketing meetings, including a national launch meeting, for the Co-Exploited Product for the United States; viii) the Party(ies) that is responsible for each Commercialization activity; provided that, unless otherwise determined by the JCC, the Parties shall jointly plan and participate in, and Licensee 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); provided that with respect to a second or subsequent Indication for a Licensed Product, the JCC will reasonably consider appointing MTI as the lead Party responsible for such activities; and

Co-Commercialization Plan. On a Collaboration Target-by-Collaboration Target basis, but only during the Co-Promote Period: 6.3.1 The Commercialization of the Opt-In Products Directed Against such Collaboration Target in the United States will be conducted pursuant to the Co-Commercialization Plan, which will at a minimum include a reasonably detailed plan for the Commercialization of the Opt-In Products Directed Against such Collaboration Target in the United States. At an appropriate time to be agreed by the JCC (but in any event least [***] months prior to commercial launch the anticipated date of First Commercial Sale of the applicable first Opt-In Product Directed Against such Collaboration Target in the United States (or such other time as may be mutually agreed by the Parties), Sanofi will prepare, in consultation with Xxxxxx via the JCC, a proposed initial Co-Exploited Commercialization Plan for the JCC’s review, discussion and approval. The JCC will endeavor to approve the initial Co-Commercialization Plan at least [***] prior to anticipated date of First Commercial Sale of an Opt-In Product Directed Against such Collaboration Target in the United States), the JCC shall agree upon the initial joint plan and budget for Commercialization of such Co-Exploited Product for the United States (the “Co-Commercialization Plan”), with the goal that each Party’s participation in the Commercialization of Co-Exploited Product for the United States 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 or reasonably can, in a timely manner, obtain, create, or add the capacity and capability to undertake such activity or responsibility. The Co-Commercialization Plan may be amended or updated from time to time by the JCC, including any amendments or updates to any anticipated timelines or to the then-current budget. The Co-Commercialization Plan shall encompass the planned Commercialization strategy in the United States for the Co-Exploited 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 Co-Commercialization Plan shall include for a given Collaboration Target will not be effective unless and until approved by the budgeted Shared Commercialization Costs for preJCC. 6.3.2 On a Collaboration Target-launch Commercialization activities in the United States and for Commercialization activities through at least [***] Calendar [***] after the First Commercial Sale of the Coby-Exploited Product in the United States. ThereafterCollaboration Target basis, the Co-Commercialization Plan shall be updated by the JCC on an annual basis. The Co-Commercialization Plan shall for a given Collaboration Target will contain at a minimum, solely in regards to the United States, the following (unless otherwise mutually agreed by the Parties): i) wholesale acquisition cost (“WAC”) pricing strategy, market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Co-Exploited Product positioning; ii) sales forecast for the next [***] Calendar Years; iii) advertising and promotion programs and strategies, including sales literature, promotional materials, media plans, symposia and speaker programs; iv) sales plans and activities, including sales force training, development of appropriate sales training materials, and strategy and rolling budget for samples; v) post-marketing studies not required to obtain or maintain Regulatory Approvals the probable Allowed Expenses for the Commercialization activities to be conducted; viperformed for the United States during the then-current Calendar Year (broken down by Calendar Quarter) and the Detail Requirements required to support [***] of the Co-Exploited ProductCommercialization Plan, and will be updated by Sanofi annually on a rolling [***] period basis. Such initial Co-Commercialization Plan will include a budget for the responsibility for which shall then-current Calendar Year commencing as of the date of such initial Co-Commercialization Plan and ending [***] of such Calendar Year and [***] thereafter [***] (each such budget, a “Co-Commercialization Budget”). The [***] of the initial Co-Commercialization Budget will be allocated between the Parties by the JCC in an equitable manner, taking into consideration all reasonable factors; vii) plan for implementation of periodic joint sales and marketing meetings, including a national launch meeting, binding. [***]. The initial Co-Commercialization Budget for the Co-Exploited Product for Commercialization Plan, and each update thereto, will be prepared by Sanofi based on Sanofi’s good faith estimation, consistent with its standard internal practices, of the probable Commercialization activities to be conducted in the United States; viii) States during the Party(ies) that is responsible for each relevant Co-Commercialization activity; provided that, unless otherwise determined by the JCC, the Parties shall jointly plan and participate inBudget period, and Licensee shall be solely responsible based on and consistent with the documents and information related to the Opt-In Products Directed Against such Collaboration Target prepared by Sanofi for administering, activities under its internal use and reference in 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); provided that with respect to budgeting process. Upon request by a second or subsequent Indication for a Licensed ProductParty, the JCC will reasonably consider appointing MTI as discuss the lead Party responsible appropriate level of detail to include in a Co-Commercialization Budget for the applicable Commercialization activities to be performed during the period covered by such Co-Commercialization Budget. 6.3.3 On a Collaboration Target-by-Collaboration Target basis, Sanofi, in consultation with Kymera via the JCC, will (a) review the Co-Commercialization Plan for a given Collaboration Target at least annually for the purpose of considering appropriate amendments thereto to be proposed to the JCC and (b) then no later than [***] of the then-current Calendar Year beginning with the first full Calendar Year of the initial Co-Commercialization Plan, provide the JCC with a proposed updated Co-Commercialization Plan for the JCC’s review, discussion and approval. The JCC will endeavor to approve such updated Co-Commercialization Plan for such activities; andCollaboration Target no later than [***] of the then-current Calendar Year. Annual updates to the Co-Commercialization Budget for such Collaboration Target will contain a proposed Co-Commercialization Budget covering (i) the next Calendar Year, broken down by Calendar Quarter, and (ii) each of the [***], in each case ((i) and (ii)), in accordance with the requirements set forth in Section 6.3.2. In addition to the annual update, either Party, through its representatives on the JCC, may propose amendments to the Co-Commercialization Plan for such Collaboration Target at any time. No update or amendment to the Co-Commercialization Plan for such Collaboration Target will be effective unless and until approved by the JCC.

Co-Commercialization Plan. On a Collaboration Target-by-Collaboration Target basis, but only during the Co-Promote Period: 6.3.1 The Commercialization of the Opt-In Products Directed Against such Collaboration Target in the United States will be conducted pursuant to the Co-Commercialization Plan, which will at a minimum include a reasonably detailed plan for the Commercialization of the Opt-In Products Directed Against such Collaboration Target in the United States. At an appropriate time to be agreed by the JCC (but in any event least [***] months prior to commercial launch the anticipated date of First Commercial Sale of the applicable first Opt-In Product Directed Against such Collaboration Target in the United States (or such other time as may be mutually agreed by the Parties), Sanofi will prepare, in consultation with Kymera via the JCC, a proposed initial Co-Exploited Commercialization Plan for the JCC’s review, discussion and approval. The JCC will endeavor to approve the initial Co-Commercialization Plan at least [***] prior to anticipated date of First Commercial Sale of an Opt-In Product Directed Against such Collaboration Target in the United States), the JCC shall agree upon the initial joint plan and budget for Commercialization of such Co-Exploited Product for the United States (the “Co-Commercialization Plan”), with the goal that each Party’s participation in the Commercialization of Co-Exploited Product for the United States 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 or reasonably can, in a timely manner, obtain, create, or add the capacity and capability to undertake such activity or responsibility. The Co-Commercialization Plan may be amended or updated from time to time by the JCC, including any amendments or updates to any anticipated timelines or to the then-current budget. The Co-Commercialization Plan shall encompass the planned Commercialization strategy in the United States for the Co-Exploited 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 Co-Commercialization Plan shall include for a given Collaboration Target will not be effective unless and until approved by the budgeted Shared Commercialization Costs for preJCC. 6.3.2 On a Collaboration Target-launch Commercialization activities in the United States and for Commercialization activities through at least [***] Calendar [***] after the First Commercial Sale of the Coby-Exploited Product in the United States. ThereafterCollaboration Target basis, the Co-Commercialization Plan shall be updated by the JCC on an annual basis. The Co-Commercialization Plan shall for a given Collaboration Target will contain at a minimum, solely in regards to the United States, the following (unless otherwise mutually agreed by the Parties): i) wholesale acquisition cost (“WAC”) pricing strategy, market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Co-Exploited Product positioning; ii) sales forecast for the next [***] Calendar Years; iii) advertising and promotion programs and strategies, including sales literature, promotional materials, media plans, symposia and speaker programs; iv) sales plans and activities, including sales force training, development of appropriate sales training materials, and strategy and rolling budget for samples; v) post-marketing studies not required to obtain or maintain Regulatory Approvals the probable Allowed Expenses for the Commercialization activities to be conducted; viperformed for the United States during the then-current Calendar Year (broken down by Calendar Quarter) and the Detail Requirements required to support [***] of the Co-Exploited ProductCommercialization Plan, and will be updated by Sanofi annually on a rolling [***] period basis. Such initial Co-Commercialization Plan will include a budget for the responsibility for which shall then-current Calendar Year commencing as of the date of such initial Co-Commercialization Plan and ending [***] of such Calendar Year and [***] thereafter [***] (each such budget, a “Co-Commercialization Budget”). The [***] of the initial Co-Commercialization Budget will be allocated between the Parties by the JCC in an equitable manner, taking into consideration all reasonable factors; vii) plan for implementation of periodic joint sales and marketing meetings, including a national launch meeting, binding. [***] The initial Co-Commercialization Budget for the Co-Exploited Product for Commercialization Plan, and each update thereto, will be prepared by Sanofi based on Sanofi’s good faith estimation, consistent with its standard internal practices, of the probable Commercialization activities to be conducted in the United States; viii) States during the Party(ies) that is responsible for each relevant Co-Commercialization activity; provided that, unless otherwise determined by the JCC, the Parties shall jointly plan and participate inBudget period, and Licensee shall be solely responsible based on and consistent with the documents and information related to the Opt-In Products Directed Against such Collaboration Target prepared by Sanofi for administering, activities under its internal use and reference in 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); provided that with respect to budgeting process. Upon request by a second or subsequent Indication for a Licensed ProductParty, the JCC will reasonably consider appointing MTI as discuss the lead Party responsible appropriate level of detail to include in a Co-Commercialization Budget for the applicable Commercialization activities to be performed during the period covered by such Co-Commercialization Budget. 6.3.3 On a Collaboration Target-by-Collaboration Target basis, Sanofi, in consultation with Kymera via the JCC, will (a) review the Co-Commercialization Plan for a given Collaboration Target at least annually for the purpose of considering appropriate amendments thereto to be proposed to the JCC and (b) then no later than [***] of the then-current Calendar Year beginning with the first full Calendar Year of the initial Co-Commercialization Plan, provide the JCC with a proposed updated Co-Commercialization Plan for the JCC’s review, discussion and approval. The JCC will endeavor to approve such updated Co-Commercialization Plan for such activities; andCollaboration Target no later than [***] of the then-current Calendar Year. Annual updates to the Co-Commercialization Budget for such Collaboration Target will contain a proposed Co-Commercialization Budget covering (i) the next Calendar Year, broken down by Calendar Quarter, and (ii) each of the [***], in each case ((i) and (ii)), in accordance with the requirements set forth in Section 6.3.2. In addition to the annual update, either Party, through its representatives on the JCC, may propose amendments to the Co-Commercialization Plan for such Collaboration Target at any time. No update or amendment to the Co-Commercialization Plan for such Collaboration Target will be effective unless and until approved by the JCC.

Co-Commercialization Plan. At an appropriate time to be agreed For any CNS Product that is the subject of Cost Profit Sharing in a Cost Profit Sharing Country, Sanofi shall prepare, in consultation with Denali and for discussion, review and approval by the JCC (but or if such CNS Products are not also Co-Commercialization Products, by the JSC), a detailed Co‑Commercialization Plan for the Commercialization of such CNS Products in any event such country. The Co‑Commercialization Plan for a Cost Profit Sharing Country shall include: (a) [***]; (b) [***]; (c) a non-binding sales and marketing forecast for such country; (d) a non-binding projection of Net Sales of such CNS Products for such country; (e) [***]; (f) [***]; *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] months prior indicates that text has been omitted and is the subject of a confidential treatment request. (g) for those CNS Products in a country where the Co‑Commercialization Option has been exercised pursuant to commercial launch of the applicable Co-Exploited Product Section 5.2.4 (Co‑Commercialization Option in the United States)U.S. and China) by Denali for one or more CNS Products, the JCC shall agree upon the initial joint plan and budget for Commercialization allocation of such Co-Exploited Product for the United States (the “Co-Commercialization Plan”)Activities between the Parties to be undertaken with respect to each of the CNS Products in the applicable country, with including the goal that allocation of responsibility for the conduct of any MSL Activities and Detailing, including the geographic allocation of each Party’s participation in the Commercialization of Co-Exploited Product for the United States shall, to the extent practicable, be substantially equal on an ongoing basis, provided that sales representatives (consistent with this Section ‎5.3.2); and (h) a Party shall not be assigned a particular Commercialization activity or responsibility unless it has or reasonably can, in a timely manner, obtain, create, or add the capacity and capability to undertake such activity or responsibility. The Co-Commercialization Plan may be amended or updated from time to time by the JCC, including any amendments or updates to any anticipated timelines or Budget with respect to the then-current budgetCommercialization Activities for each Cost Profit Sharing Product in such country. The For each Co-Commercialization Plan shall encompass the planned Commercialization strategy in the United States for the Co-Exploited 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 Co-Commercialization Plan shall include the budgeted Shared Commercialization Costs for pre-launch Commercialization activities in the United States and for Commercialization activities through at least [***] Calendar [***] after the First Commercial Sale of the Co-Exploited Product in the United States. ThereafterCountry, the Co-Commercialization Plan shall be updated by the JCC on an annual basis. The Co-Commercialization Plan shall contain at a minimum, solely in regards to the United States, the following (unless otherwise mutually agreed by allocate Co‑Commercialization Activities between the Parties): i) wholesale acquisition cost (“WAC”) pricing strategy, market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Co-Exploited Product positioning; ii) sales forecast for the next [***] Calendar Years; iii) advertising and promotion programs and strategies, including sales literature, promotional materials, media plans, symposia and speaker programs; iv) sales plans and activities, including sales force training, development of appropriate sales training materials, and strategy and budget for samples; v) post-marketing studies not required to obtain or maintain Regulatory Approvals to be conducted; vi) the Detail Requirements required to support the Co-Exploited Product, the responsibility for which shall be allocated between the Parties by the JCC in an equitable manner, taking into consideration all reasonable factors; vii) plan for implementation the Parties’ respective actual or reasonably anticipated capabilities, infrastructure and resources in the applicable country, as the case may be, relevant to the CNS Program at the time of periodic joint sales and marketing meetingsexpected First Commercial Sale of the CNS Products therein. Notwithstanding the foregoing, including a national launch meeting, for if Denali exercises the Co-Exploited Product Commercialization Option the Co‑Commercialization Plan shall provide for sales representatives of each Party to be deployed in at least some of the United States; viii) the Party(ies) that is responsible for each Commercialization activity; provided that, unless otherwise determined by the JCC, the Parties shall jointly plan and participate in, and Licensee 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); provided that with respect to a second or subsequent Indication for a Licensed Product, the JCC will reasonably consider appointing MTI as the lead Party responsible for major metropolitan areas in such activities; andcountry.

Co-Commercialization Plan. At an appropriate time to be agreed by In the JCC (but in any event [***] months prior to commercial launch of that ARQULE exercises the applicable Co-Exploited Product in Commercialization Option, within * (*) days after the United States)Initiation of a Phase 3 Clinical Trial with respect to each Licensed Product, the JCC shall agree upon the initial joint plan and budget for Commercialization of such DS shall, with advance input from ARQULE, prepare a Co-Exploited Product for the United States Commercialization plan (the “Co-Commercialization Plan”), with the goal that ) for each Party’s participation in the Commercialization of Co-Exploited Commercialized Licensed Product for the United States shallCo-Commercialization Territory which shall include, to the extent practicable, be substantially equal on an ongoing basis, provided that a Party shall but not be assigned limited to, (a) demographics and market dynamics, market strategies, and estimated launch date of such Co-Commercialized Licensed Product in the Co Commercialization Territory, (b) a particular sales and expense forecast (including at least five (5) years of estimated sales and expenses), manufacturing plans and targeted label claims for such Co-Commercialized Licensed Product in the Co-Commercialization activity or responsibility unless it has or reasonably canTerritory, (c) a marketing plan (including five (5) year advertising and Detailing forecasts and Pricing strategies) for such Co-Commercialized Licensed Product in the Co-Commercialization Territory, (d) a timely mannerfive (5) year budget for such Co-Commercialized Licensed Product for the Co-Commercialization Territory, obtainand (e) sales force strategy, createtraining plans, or add the capacity territorial divisions and capability to undertake allocation of targeted audience. DS shall submit such activity or responsibility. The Co-Commercialization Plan may be amended or updated from time to time by the JCC, including any amendments or updates to any anticipated timelines or to the thenUSJCC for review and approval within * (*) Business Days after it is prepared. USJCC members shall use reasonable efforts to reach agreement on any such Co-current budgetCommercialization Plan. The In the event that, despite reasonable efforts, agreement on a Co-Commercialization Plan shall encompass cannot be reached by the planned Commercialization strategy in USJCC within * (*) Business Days after the United States for the USJCC first meets to review and approve such Co-Exploited Product and Commercialization Plan, then DS shall set forth have the corresponding budget of Shared Commercialization Costs, anticipated timelines, Commercialization activities right to be performed by each Party, commercial supply forecasts, and make the other matters described below. The initial final decision on whether to approve such Co-Commercialization Plan but shall include the budgeted Shared Commercialization Costs for pre-launch Commercialization activities only exercise such right in the United States and for Commercialization activities through at least [***] Calendar [***] good faith after the First Commercial Sale full consideration of the Co-Exploited Product in the United Statespositions of both Parties. Thereafter, the The Co-Commercialization Plan shall be updated by the JCC on an annual basisDS, with advance input from ARQULE, not less than annually. The Each amendment or modification of each Co-Commercialization Plan for each Licensed Product that is prepared by DS with advance input from ARQULE shall contain at a minimum, solely in regards be submitted to the United States, the following USJCC for its review and approval within * (unless otherwise mutually agreed by the Parties): i*) wholesale acquisition cost (“WAC”) pricing strategy, market research and strategy, including market size, dynamics, growth, customer segmentation, competitive analysis and Co-Exploited Product positioning; ii) sales forecast for the next [***] Calendar Years; iii) advertising and promotion programs and strategies, including sales literature, promotional materials, media plans, symposia and speaker programs; iv) sales plans and activities, including sales force training, development of appropriate sales training materials, and strategy and budget for samples; v) post-marketing studies not required Business Days after it is prepared. USJCC members shall use reasonable efforts to obtain reach agreement on any such amendment or maintain Regulatory Approvals modification to be conducted; vi) the Detail Requirements required to support the Co-Exploited ProductCommercialization Plan. In the event that, the responsibility for which shall be allocated between the Parties by the JCC in despite reasonable efforts, agreement on an equitable manner, taking into consideration all reasonable factors; vii) plan for implementation of periodic joint sales and marketing meetings, including a national launch meeting, for amendment or modification to the Co-Exploited Product for the United States; viii) the Party(ies) that is responsible for each Commercialization activity; provided that, unless otherwise determined Plan cannot be reached by the JCCUSJCC within * (*) Business Days after the USJCC first meets to review and approve such amendment or modification, then DS shall have the Parties right to make the final decision on whether to approve such amendment or modification but shall jointly plan and participate in, and Licensee shall be solely responsible for administering, activities under only exercise such right in good faith after full consideration of 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); provided that with respect to a second or subsequent Indication for a Licensed Product, the JCC will reasonably consider appointing MTI as the lead Party responsible for such activities; andpositions of both Parties.