Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products On a Product by the Parties in the Field in the Territory. No Product basis, not later than [***] prior to sixty (60) days after the anticipated launch filing of the Shared first application for Regulatory Approval of a Product in the first country in the Copromotion Territory, the JCC will develop MSC shall prepare and submit to the JSC approve a rolling multiyear (not less than three (3) years) plan for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCCMSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. The JCC will update Not later than thirty (30) days after the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization filing of the Shared first application for Regulatory Approval of a Product in the Field Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the Territory and (h) a budget for activities conducted under the Commercialization Plan upcoming calendar year (the “Commercialization Budget”first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will include a meaningful role specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for both Partiesthe Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In allocating responsibilities between preparing and updating the PartiesCopromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the JCC MSC will take into consideration each Party’s expertisefactors such as market conditions, capabilities, staffing regulatory issues and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCcompetition.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. A designated Party or its relevant Affiliate shall be the lead Commercializing Party for Products in the Field in the Territory (the “Lead Commercialization Party”)2. The Lead Commercialization Party shall be agreed to by the Parties after holding good faith discussions regarding which Party is best positioned to serve in the function during the negotiation of the Joint Development & Commercialization Agreement as set forth in Section 4.1.1 of the Research Collaboration Agreement. No later than [***] twelve months prior to the anticipated first commercial launch of the Shared a Product in the first country in the Territory, the JCC JCC, will develop and submit to the JSC for approval, a Commercialization plan (as may be amended, the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared such Product in the Field in the Territory. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] an annual basis (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***]an annual basis, including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.

Commercialization Plan. The JCC will oversee All Commercialization with respect to a Product under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of Shared Products by such Product and the Parties in the Field in the Territory. No later than [***] prior activities to the anticipated launch of the Shared Product in the first country in the Territorybe carried out with respect thereto, the JCC will develop and submit to the JSC together with a proposed budget for approvalsuch activities (each, a Commercialization plan (the “Commercialization Plan”) that sets forth ). The Parties, through the JSC, shall agree upon a preliminary Commercialization Plan for each Product at least ************ prior to anticipated Regulatory Approval for such Product. A copy of each Commercialization Plan shall be attached hereto as part of Exhibit C. During the Commercialization activities to be undertaken by the Parties Phase with respect to each Product, the Parties, through the JSC, shall update the Commercialization Plan with respect to such Product on an annual basis prior to the commencement of the Shared next calendar year, or more often as determined by the JSC. Each updated Commercialization Plan shall include, for the subsequent ************, the projection of the plan for Commercialization Activities for the Product in each Territory and timelines for performing such activities, the Territoryprojected Net Sales and other revenues from the sale of the Product, together with an updated Commercialization budget. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by shall contain an estimation of the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it resources that each Party intends to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted employ in connection with the Commercialization of the Shared Product in relevant Product. In addition, the Field in the Territory and (h) a budget for activities conducted under JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and will report any variations to the Parties in writing. If, in any quarter, there is a variation of ************ or greater from the budget or from projected Net Sales and other revenues, the JSC will revise the Commercialization Plan and budget for the applicable Product ************ prior to the commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one of a calendar year, a revised Commercialization Plan and budget must be prepared at least ************ prior to the commencement of quarter three of such calendar year. Until such time as an updated Commercialization Plan is approved in accordance with this Section 6.1, the preceding Commercialization Plan (the “Commercialization Budget”)including, without limitation, all budget projections therein) shall remain in effect. The JSC shall not approve any Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between that is inconsistent with or contradicts the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside terms of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCthis Agreement.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] 12 months prior to the anticipated launch Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the Shared Product in the first country in Territory during the Territory, the JCC will develop and submit period beginning six (6) months prior to the JSC for approval, a Commercialization plan anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role information regarding planned Commercialization activities for both Parties. In allocating responsibilities between Supplied Item in the PartiesTerritory, the JCC will take into consideration each Party’s expertiseincluding, without limitation, pre-launch activities, establishment of government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, staffing supply and available resources to take on such inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as well as market research to develop Product positioning key messages). Cardiome may amend or update the Parties’ intention Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall in any event provide CRISPR an opportunity SteadyMed with annual updates to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, in each case, subject to the Parties will jointly be responsible for conducting all requirements of this Article 6. SteadyMed may provide comments and suggestions regarding the Commercialization Plan and any amendment or update thereto to Cardiome, and Cxxxxxxx agrees to consider such comments and suggestions in good faith. As used herein, the term “Commercialization Plan” means the version of the Commercialization Plan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities outside and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the United StatesTerritory during each Quarter, which shall include such activities detail regarding the matters described in Sections 3.2(c), and Sections 3.2(c) through 3.2(g), as the JSC may request or require or as may be reasonably required for SteadyMed to be determined by the JSCassess Cardiome’s compliance with its obligations under Sections 6.3 and 6.4.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No On a Collaboration Product-by-Collaboration Product basis, not later than [***] prior to the anticipated launch after commencement of the Shared Product in the first country Phase III Clinical Trial of a R&D Candidate in the Territory, the JCC will develop ELAN shall prepare and submit to the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) plan for approval, a Commercialization plan (Commercializing the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Collaboration Product in the TerritoryTerritory (the "Commercialization Plan"), which plan shall include without limitation [***]. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCCELAN at least once each calendar year. Not later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calen dar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and which shall include [***]. The JCC Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will update specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan on and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (or more frequently as needed) the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and submit it charged to their respective R&D Accounts shall be shared equally by the JSC Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for approval. The Commercialization Plan will include (a) that year in respect of the Global Branding Strategythen current Post BLA Filing Budget, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on pay to ELAN [***], including information related ] of any Post BLA Excess Charges charged by ELAN to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted is R&D Account in connection with the Commercialization each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the Shared Product relevant Post BLA Filing Budget. If CAT's liability hereunder in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside any year does exceed [***] of [***] of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, relevant Post BLA Filing Budget then this Section shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCapply mutatis mutandis thereto.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the All Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory shall be conducted pursuant to a commercialization plan, which shall set forth the plan for the Detailing and (h) a budget for Promotion of the Product in the Field in the Territory in accordance with Applicable Laws and the activities conducted under the Commercialization Plan to be carried out related thereto (the “Commercialization BudgetPlan”). The Parties have agreed upon a high-level outline of the Commercialization Plan, as further described on Exhibit 6.2. No later than ninety (90) days after the Effective Date, and prior to January 1 of each and every Calendar Year after the first Calendar Year, United Therapeutics shall submit to the JSC for review an updated Commercialization Plan. For purposes of clarification, after submission of the first updated Commercialization Plan will include a meaningful role for both Partiesand not later than ninety (90) days after the Effective Date, United Therapeutics shall submit the first annual updated Commercialization Plan to the JSC prior to the start of the second Calendar Year (i.e., prior to January 1, 2010). In allocating responsibilities between the PartiesIf Lilly determines that such updated Commercialization Plan does not comply with Applicable Laws, the JCC will take into consideration each Party’s expertise, capabilities, staffing including laws relating to promotional and available resources to take on such activities, advertising materials as well as the Parties’ intention to provide CRISPR an opportunity to build accepted industry standards and expand its expertiseLilly’s ethical policies, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, each case with respect to the United States Product in the Field in the Territory, or outside of that the United Statesactivities conducted under such updated Commercialization Plan are reasonably likely to materially adversely affect products in Lilly’s Domain, respectively, Lilly shall be referred permitted to herein as the “Lead Commercialization Party” for propose, in good faith, revisions to such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the updated Commercialization Plan, and United Therapeutics shall revise such Commercialization Plan. In the Parties will jointly be responsible for conducting all event of any inconsistency between the Commercialization activities outside Plan and this Agreement, the terms of the United States, such activities to be determined by the JSCthis Agreement shall prevail.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No On a Collaboration Product-by-Collaboration Product basis, not later than [***] prior to the anticipated launch after commencement of the Shared Product in the first country Phase III Clinical Trial of a R&D Candidate in the Territory, the JCC will develop ELAN shall prepare and submit to the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multi-year (being not less than[***]) plan for approval, a Commercialization plan (Commercializing the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Collaboration Product in the TerritoryTerritory (the "Commercialization Plan"), which plan shall include without limitation [***]. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCCELAN at least once each calendar year. Not later than [***] after the filing of the first BLA for an R&D Candidate in the Territory and thereafter on or before August 31 of each calendar year, ELAN shall prepare and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan (the "Post BLA Filing Plan"), which plan shall be based on and shall supersede the then current Commercialization Plan and which shall include [***]. The JCC Post BLA Filing Budget shall be based on and shall supersede the relevant Commercialization Budget. The Post BLA Filing Plan will update specify [***]. In preparing and updating the Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan on and each Post BLA Filing Budget, ELAN will take into consideration factors such as market conditions, regulatory issues and competition. If in any year of a Post BLA Filing Plan the aggregate expenses incurred by the Parties are in excess of [***] of the amounts set out in the Post BLA Filing Budget for that year (a "Post BLA Excess Year") then each Party shall charge to its R&D Account [***] of such [***] and, in addition, ELAN shall charge to its R&D Account any amounts in excess of such [***] (or more frequently as needed) the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and submit it charged to their respective R&D Accounts shall be shared equally by the JSC Parties in accordance with Section 5.3.1 and Section 5.3.4; provided, however, in any years following a Post BLA Excess Year CAT shall, in addition to any sums which may be due to ELAN under Section 5.3.4 for approval. The Commercialization Plan will include (a) that year in respect of the Global Branding Strategythen current Post BLA Filing Budget, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on pay to ELAN [***], including information related ] of any Post BLA Excess Charges charged by ELAN to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted is R&D Account in connection with the Commercialization each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the Shared Product relevant Post BLA Filing Budget. If CAT's liability hereunder in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside any year does exceed [***] of [***] of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, relevant Post BLA Filing Budget then this Section shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCapply mutatis mutandis thereto.

Commercialization Plan. The JCC Parties will oversee discuss, through the Joint Commercialization Subcommittee, the Commercialization of Shared the Products as provided in Section 4.2.2(b) and this Article VI and will agree upon a global commercialization plan (the “Global Commercialization Plan”), which will form the guiding principles for Commercialization activities for the Products in the Amicus Territory and the GSK Territory. An initial draft of the guiding principles to be used by the Parties Joint Commercialization Subcommittee in developing the Field Global Commercialization Plan is attached hereto as Schedule 6.1. Promptly after the Restatement Effective Date, and in the Territory. No later than [any event within ***] *** prior to the anticipated launch first projected Launch of the Shared a Product in the first country in the Territory, the JCC will Joint Commercialization Subcommittee shall develop and submit the Parties shall mutually agree upon a Global Commercialization Plan in accordance with the Global Commercialization Plan guiding principles set forth on Schedule 6.1. Thereafter, the Joint Commercialization Subcommittee will review and make any necessary mutually-agreed upon changes to the then-current Global Commercialization Plan and will provide quarterly updates to the JSC for approvalwith respect thereto in accordance with Section 4.2.2(c). The development of the Global Commercialization Plan and any changes thereto must be made by mutual agreement of the Parties, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties and neither Party shall have final decision making authority with respect to the Global Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both PartiesPlan. In allocating responsibilities between the Parties, event that the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, JCS disagrees with respect to any proposed changes to the United States or outside of the United StatesGlobal Commercialization Plan, respectively, such dispute shall be referred submitted for review by the JSC at the next regularly scheduled JSC meeting. If the Parties via the JSC are unable to herein as mutually agree on such disputed proposed changes to the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the then-current Global Commercialization Plan, the then-current Global Commercialization Plan shall remain unmodified and such disagreement shall not be subject to further escalation or to dispute resolution in accordance with Section 4.1.5 or Section 16.2. The Parties will jointly be responsible for conducting all coordinate Commercialization activities outside in their respective territories, including coordination of marketing and branding activities, via the United StatesJoint Commercialization Subcommittee. Notwithstanding the foregoing, such activities pursuant to be determined by Section 4.1.5(c), each Party shall have final decision-making authority with respect to Commercialization of Products in its respective territory pursuant to this Agreement, provided that each Party shall exercise its final decision-making authority in its respective territory in a manner that is consistent with the JSCGlobal Commercialization Plan. ****** - Material has been omitted and filed separately with the Commission.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [On a Product-by-Product basis, *** the JSC shall prepare and approve a rolling multiyear ( *] prior to the anticipated launch of the Shared ** ) plan for Commercializing such Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan Territory (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared ), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined shall be updated by the JCC. The JCC will update JSC at least once each calendar year such that it addresses no less than the Commercialization Plan on [***] * . Not later than thirty (or more frequently as needed30) and submit it to days after the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization filing of the Shared first application for Regulatory Approval of a Product in the Field in the Territory and thereafter on or before September 30 of each calendar year, the JSC shall prepare an annual commercialization plan (h) the “Annual Commercialization Plan”), which plan is based on the then current Commercialization Plan and includes a comprehensive market development, marketing, customer support, sales, supply and distribution strategy, including an overall budget for activities conducted under anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Commercialization Plan shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan will specify which audiences and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party (which as much as is reasonably possible shall represent an equal effort on the part of each Party), as well as market and sales forecasts and related operating expenses, for the Product in each country of the Territory, and budgets for projected Pre-Marketing Expenses, Distribution Expenses, Third Party License Fees, Assigned Sales Force Adjustment Payment, Working Capital Charges, Sales and Marketing Expenses and Post- CONFIDENTIAL IcNFORMATION OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS (*) DENOTE SUCH OMISSIONS. Approval Research and Regulatory Expenses. In preparing and updating the Commercialization Plan (the “and each Annual Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the PartiesPlan, the JCC JSC will take into consideration each factors such as market conditions, regulatory issues and competition. The number of Details assigned to a Party by the JSC in accordance with this Section shall be such Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSCAssigned Sales Force Effort.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No (a) Commencing no later than [***] ]* prior to the anticipated launch of the Shared first Licensed Product, Cubist shall prepare and deliver to the JCT, by no later than []* of each Calendar Year, a written plan and budget that describes in detail the Commercialization activities (including pre-launch and launch activities, if applicable) to be undertaken with respect to Licensed Product in the first country Profit-Share Territory in the Territory, next Calendar Year and the JCC will develop and submit dates by which such activities are targeted to the JSC for approvalbe accomplished (each, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between (including the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR budget) shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, contain sufficient detail with respect to Commercialization tactics and other matters to enable the United States or outside JCT to conduct a meaningful review of the United StatesCommercialization Plan, respectively, and the JCT shall be referred approve the first Commercialization Plan for the Profit-Share Territory no later than []* prior to herein as launch of the “Lead Commercialization Party” for such jurisdiction (as applicablefirst Licensed Product in the Profit-Share Territory. Thereafter, the “Lead JCT shall review the Commercialization Party” Unless otherwise specified Plan not less frequently than annually and shall develop Commercialization Plan updates, which shall include updated budgets for the Profit-Share Territory, for each Calendar Year. Cubist may also develop and *Confidential Treatment Requested. Omitted portions filed separately with the Commission. submit to the JCT for review from time to time other proposed substantive amendments to the Commercialization Plan. Amendments and updates to the Commercialization Plan, including any budgets for the Profit-Share Territory contained in the Commercialization Plan, shall not be effective without the Parties will jointly be responsible for conducting all approval of the JCT. Notwithstanding anything in this Agreement to the contrary, if Cubist engages or uses a Third Party to perform any Commercialization activities outside of in the United StatesProfit-Share Territory under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or where there will be a material penalty for early termination that is inconsistent with industry standards, such activities to be determined by the JSC[]*.

Commercialization Plan. The JCC will oversee strategy and budget for the Commercialization of Shared Products by of, the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country Territory will be described in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization comprehensive plan (the “Commercialization Plan”) and in a budget (the “Incremental Cost Budget”), each developed by EPI Health based on good faith assumptions regarding the then-current forecast for the Product in the Field in the Territory, in consultation with MC2, and each shall be subject to final approval by MC2, such approval not to be unreasonably withheld; provided that, notwithstanding the foregoing or anything to the contrary herein, (i) the Incremental Cost Budget as it pertains to the EPI Health Sales Representatives must be mutually agreed by MC2 and EPI Health; (ii) neither Party shall be permitted to decrease the number of EPI Health Sales Representatives to less than [***] or increase the number of EPI Health Sales Representatives to more than [***], and (iii) MC2 may, in its sole discretion and acting in good faith, increase the Incremental Cost Budget relative to the then-current Incremental Cost Budget by no more than ten percent (10%) or decrease the Incremental Cost Budget relative to the then-current Incremental Cost Budget by no more than fifty percent (50%) solely with respect to increases or decreases in the Incremental Costs for non-inventory and non-personnel costs, provided that sets forth MC2 may not reduce the Incremental Cost Budget for noncancellable expenses so long as EPI Health uses Commercially Reasonable Efforts to cancel or reduce such expenses (including in accordance with the terms of any contract therefor) as soon as practicable following a request to do so by MC2 ((i) through (iii), the “Agreed Budget Limitations”). The Commercialization Plan for Calendar Year 2022 is attached hereto as Exhibit 7.2 A, and the Incremental Cost Budget for Calendar Year 2022 (including the Incremental Costs actually incurred by EPI Health since the Amendment Effective Date until the date on which the Condition Precedent is satisfied) is attached hereto as Exhibit 7.2 B. The Commercialization Plan and Incremental Cost Budget shall be updated and may be amended during the Term in accordance with Section 7.3 and Section 9.3. The Commercialization Plan will be used as the basis for the Commercialization activities to be undertaken by under this Agreement and shall specifically describe the Parties with respect to (a) Commercialization activities for the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basisTerritory (including messaging, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) branding, list price and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategyrebating strategy, pricing, advertising, education, planning, marketing, promotion, product sampling and sales force training and allocation), (b) a marketing strategykey tactics for implementing those activities, (c) a communications strategy that includes plans for public relationsspecific resource commitments required of the Parties, conferences including number and exhibitions location of EPI Sales Territories, number of EPI Health Sales Representatives, number of Details by position, and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand packagemarketing spend, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategiesField Force Detailing Plan, (e) a detailing strategy, three (3)-year sales forecast and (f) a pricing strategy, (g) all any other material activities to be conducted in connection with information necessary or useful for the successful Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under Territory. In the event of any inconsistency between either the Commercialization Plan (or Incremental Cost Budget, on the “Commercialization Budget”)one hand, and this Agreement, on the other hand, the terms of this Agreement shall govern and control. The Notwithstanding anything to the contrary in this Agreement, the Commercialization Plan will include a meaningful role shall specify and account for both Partiesthe performance of EPI Commercialization Activities by EPI Health and MC2 Commercialization Activities by MC2. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources no event shall EPI Health be required to take on such activities, as well as the Parties’ intention perform any function or activity or to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified purchase inventory set forth in the Commercialization Plan, Plan the Parties will jointly be responsible for conducting all Commercialization activities outside cost of the United States, such activities to be determined which is not covered by the JSCthen-current Incremental Cost Budget.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to following Evelo notifying ALJ in writing that the anticipated launch first dose in the first patient of any Phase III Clinical Trial for a Product has occurred anywhere in the world after the Effective Date, ALJ will prepare: (a) a reasonably detailed written plan of the Shared Commercialization activities for such Product in the first country in the Territory, the JCC will develop Territory and submit such plan to the JSC for approvalPCC to review, discuss, and determine whether to approve (as such plan may be updated as set forth below in this Section 6.1 (Commercialization Plan), a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) ); and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategydetailed, (c) a communications strategy that includes plans for public relations, conferences and exhibitions written budget of the Distribution Costs and other external meetingsFTE Costs, internal meetings Out-of-Pocket Expenses, Manufacturing Costs, and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for Other Operating Expenses expected to be incurred by or on behalf of each Party in the implementation performance of such strategies Commercialization activities on [***]a Calendar Year basis (as may be updated pursuant to this Section 6.1 (Commercialization Plan), including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing all Commercialization activities allocated to it. CRISPR shall be undertaken by each Party for the Commercializing lead for Shared Products in the United States Territory and Vertex shall be an allocation between the Commercializing lead Parties for Shared Products outside all such activities (including, in the case of Evelo, manufacturing of the United StatesAPI for each Product). The Commercializing leadAt least once each Calendar Year, with respect ALJ will provide to the United States PCC an update to the then-current Commercialization Plan and Commercialization Budget, and may provide additional updates thereto from time to time, and the PCC will review, discuss, and determine whether to approve any proposed amendments or outside updates to the Commercialization Plan (including any amendments to the Commercialization Budget) in accordance with Section 3.3 (Decision-Making). If an amendment to the Commercialization Budget is required for the completion of the United States, respectively, shall be referred to herein as the “Lead a Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified activity already contemplated in the Commercialization Plan, and the Parties PCC does not agree to such amendment to the Commercialization Budget for such Commercialization activity, each Party shall be relieved of its obligations under Section 6.2 to the extent directly relating to the specific Commercialization activity or portion of such Commercialization activity for which the increased budget was required. The Commercialization Plan for a Product (including each update thereto) must be consistent with Evelo’s global brand strategy and global key messaging for such Product (each, a “Global Commercialization Plan”), if and as provided to ALJ in writing by Evelo from time to time during the Term. ALJ will jointly be responsible for conducting all not perform any Commercialization activities outside of for the United States, such activities to be determined by Products for the JSCTerritory other than in accordance with the Commercialization Plan.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] 12 months prior to the anticipated launch Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the Shared Product in the first country in Territory during the Territory, the JCC will develop and submit period beginning six (6) months prior to the JSC for approval, a Commercialization plan anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role information regarding planned Commercialization activities for both Parties. In allocating responsibilities between Supplied Item in the PartiesTerritory, the JCC will take into consideration each Party’s expertiseincluding, without limitation, pre-launch activities, establishment of government or private payor and reimbursement capabilities and pharmaceutical logistics capabilities, staffing supply and available resources to take on such inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as well as market research to develop Product positioning key messages). Cardiome may amend or update the Parties’ intention Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall in any event provide CRISPR an opportunity SteadyMed with annual updates to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, in each case, subject to the Parties will jointly be responsible for conducting all requirements of this Article 6. SteadyMed may provide comments and suggestions regarding the Commercialization Plan and any amendment or update thereto to Cardiome, and Cardiome agrees to consider such comments and suggestions in good faith. As used herein, the term “Commercialization Plan” means the version of the Commercialization Plan most recently provided by Cardiome to SteadyMed. Cardiome shall deliver annual written reports to SteadyMed of the Commercialization activities outside and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the United StatesTerritory during each Quarter, which shall include such activities detail regarding the matters described in Sections 3.2(c), and Sections 3.2(c) through 3.2(g), as the JSC may request or require or as may be reasonably required for SteadyMed to be determined by the JSCassess Cardiome’s compliance with its obligations under Sections 6.3 and 6.4.

Commercialization Plan. The JCC Cipla will oversee be responsible for preparing and presenting to the JSC a Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] Plan twelve (12) months prior to the anticipated launch Regulatory Approval of the Shared Product for marketing in the first U.S. or in any other country in the TerritoryTerritory in connection with the Pulmonary Indication. Following JSC review and approval of such Commercialization Plan, the JCC will develop JSC shall review the implementation and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization execution of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] at least a quarterly basis; provided, that if any unexpected circumstance occurs that would result in a variation from the Commercialization budget set forth in such Commercialization Plan of fifteen percentage (15%) or more frequently as neededgreater, then the JSC shall promptly convene a special meeting to review the causes for such variation and establish a plan for remediation. For clarity, in no event, will either Party be required to incur Commercialization Costs in excess of one hundred and fifteen percentage (115%) of the amount set forth in the budget and/or Commercialization Costs contained in the Commercialization Plan unless such costs are pre-approved by JSC. By the June 30th following the date of the initial Commercialization Plan and submit it each June 30th thereafter, Cipla, will prepare and present to the JSC for approval. The an updated Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation immediately following Calendar Year (e.g., Cipla will prepare and present to the JSC the Calendar Year 2021 Commercialization Plan by September 3, 2020). In the event that the Product receives Regulatory Approval for a Pulmonary Indication in any country other than the U.S., the JSC shall make a determination if the Product will be Commercialized in such jurisdiction within thirty (30) days of such strategies on [***]Regulatory Approval and, including information related if the JSC so determines to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with Commercialize the Commercialization of the Shared Product in the Field in the Territory such jurisdiction, then Cipla shall prepare and present Commercialization Plans (hincluding annually updated Commercialization Plans) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, following the “Lead Commercialization Party” Unless otherwise specified in same procedure set forth above for the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.U.S.

Commercialization Plan. The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior ], Astellas shall prepare and provide to the anticipated launch JCC for review and discussion a written plan for the Commercialization of the Shared such Collaboration Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan an Astellas’ fiscal year (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will shall include a meaningful role reasonably detailed description of and anticipated timeline for both PartiesAstellas’, its Affiliates’ and sublicensees’ Commercialization activities with respect to such Collaboration Product, including, without limitation pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. In allocating responsibilities between the PartiesIf Cytokinetics exercises its Co-Promotion option for a Collaboration Product, the JCC will take into consideration each Party’s expertise, capabilities, staffing Commercialization Plan shall also include a reasonably detailed description of and available resources to take on such activities, anticipated timeline for Cytokinetics’ Co-Promotion activities as well as a budget therefor, which shall be consistent with Section 8.6 below. Astellas shall periodically (at least on an annual basis) prepare updates and amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related product forecasts, relative success of the Collaboration Products and other relevant factors influencing such plans and activities. Astellas shall submit all updates and amendments to its Commercialization Plan to the JCC for review and discussion. The Commercialization Plan for any Collaboration Product [*] must be agreed by the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing leadCommercialization Plan and, with respect to the United States or outside of the United States, respectivelyif Cytokinetics exercises its Co-Promotion option, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be pay Cytokinetics [*] determined by the JSCJCC) for its Co-Promotion activities as set forth in the Co-Promotion Agreement.

Commercialization Plan. The JCC will oversee All Commercialization with respect to a Product under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of Shared Products by such Product and the Parties in activities to be carried out with respect thereto, together with a proposed budget for such activities (each, a “Commercialization Plan”). The Operating Parties, through the Field in the Territory. No later than [JSC, shall agree upon a preliminary Commercialization Plan for each Product at least ***] ********* prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC Regulatory Approval for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth such Product. During the Commercialization activities to be undertaken by the Parties Phase with respect to each Product, the Operating Parties, through the JSC, shall update the Commercialization Plan with respect to such Product on an annual basis prior to the commencement of the Shared next calendar year, or more often as determined by the JSC. Each updated Commercialization Plan shall include, for the subsequent ************, the projection of the plan for Commercialization Activities for the Product in each Territory and timelines for performing such activities, the Territoryprojected Net Sales and other revenues from the sale of the Product, together with an updated Commercialization budget. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by shall contain an estimation of the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it resources that each Operating Party intends to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted employ in connection with the Commercialization of the Shared Product in relevant Product. In addition, the Field in the Territory and (h) a budget for activities conducted under JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and will report any variations to the Operating Parties in writing. If, in any quarter, there is a variation of ************ or greater from the budget or from projected Net Sales and other revenues, the JSC will revise the Commercialization Plan and budget for the applicable Product ************ prior to the commencement of the second quarter following the quarter in which the variation occurred. For example, if a ************ variation is reported in quarter one of a calendar year, a revised Commercialization Plan and budget must be prepared at least ************ prior to the commencement of quarter three of such calendar year. Until such time as an updated Commercialization Plan is approved in accordance with this Section 6.1, the preceding Commercialization Plan (the “Commercialization Budget”)including, without limitation, all budget projections therein) shall remain in effect. The JSC shall not approve any Commercialization Plan will include a meaningful role for both Partiesthat is inconsistent with or contradicts the terms of this Agreement. In allocating responsibilities between Confidential material omitted and filed separately with the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing Securities and available resources to take on Exchange Commission. Asterisks denote such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSComissions.