Common use of Commercialization Plan Clause in Contracts

Commercialization Plan. On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for 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 shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the 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 upcoming calendar year (the 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 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

Commercialization Plan. On a Product by Product basis, not later than sixty (60i) days after The initial plan for the filing Commercialization of the first application for Regulatory Approval of a Product in the Copromotion Field in the Partner Territory is attached to this Agreement as Exhibit 5.1 (the “Initial Commercialization Plan”), and includes in reasonable detail: the number of sales representatives to be deployed, an account/physician target-specific detail and coverage plan (including, “call points”), the dollar amount and allocation of planned promotional and marketing expenses, the projected dates for the First Commercial Sale of the Product in the Partner Territory, as well as an outline regarding the MSC price and brand positioning of the Product, which shall be consistent with the minimum commercial diligences set forth in Section 5.2(b). The Initial Commercialization Plan can be adjusted by the JSC. (ii) Partner shall prepare for the JSC’s review updates of the Commercialization Plan on an ongoing basis, and approve in any event, the JSC shall review the then-current Commercialization Plan in the sixth (6th) and twelfth (12th) month of each calendar year. (iii) Partner shall carry out and manage, and shall cause its Affiliates and Sublicensees to carry out and manage, the Commercialization of the Product in the Partner Territory in material accordance with the then-current Commercialization Plan and the provisions of this Agreement. (iv) If, after taking into account all potential opportunities with respect to the Product in a rolling multiyear comprehensive analysis of the relevant clinical science, clinical need, published data and commercial considerations, the JSC determines that Partner should develop and present to Bioprojet a go-to-market Commercialization plan for the OSA Target Indication (not less than the “OSA Proposal”), then Partner shall do so within ninety (90) days of such determination. The OSA Proposal shall take into account the Parties’ mutual agreement that the Product’s optimal brand positioning and pricing strategy in the Partner Territory are the Narcolepsy with Cataplexy and EDS Target Indications and include, among other things, (i) analysis of potential regulatory options for the Product in the Partner Territory for the Narcolepsy with Cataplexy, EDT and OSA Target Indications, including an assessment of the viability of different brand names, and simultaneous Commercialization of the same compound, for such three (3) yearsTarget Indications, (ii) commercial payor/pricing analysis for potential managed care contracting strategies for the OSA Target Indication and (iii) a full medical affairs development program to support the OSA Target Indication. The Parties shall discuss the OSA Proposal in good faith and, if the Parties mutually agree upon a go-to-market Commercialization plan for Commercializing such Product the OSA Target Indications (whether incorporating, in whole or in part, the Copromotion Territory (elements of the "Copromotion Territory Commercialization Plan"OSA Proposal or otherwise), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Initial Commercialization Plan shall be updated amended by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing mutual written agreement of the first application for Regulatory Approval of a Product in the 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 Parties to reflect such mutually agreed upon go-to-market 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 upcoming calendar year (the 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 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competitionplan.

Commercialization Plan. On (a) The Commercialization of the Product under this Agreement in Cytokinetics Territory and Astellas Territory shall be coordinated under a Commercialization plan (the “Commercialization Plan”). The Commercialization Plan shall include a reasonably detailed description of and anticipated timeline for the Parties’, their respective Affiliates’ and sublicensees’ Commercialization activities with respect to the Product by Product basisin their respective territory, not including pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. (b) No later than sixty [*], or promptly following the Effective Date (60) days after if the filing of the first application for Regulatory Approval of a Product in the Copromotion TerritoryEffective Date occurs during such [*] period), the MSC JCC shall prepare and approve a rolling multiyear the initial Commercialization Plan. Thereafter, from time to time during the Term (not but no less than three (3) years) plan for Commercializing such Product annually), the JCC shall prepare and approve updates and amendments, as appropriate, to the then-current Commercialization Plan to reflect changes in its plans, including in response to changes in the Copromotion Territory marketplaces and related product forecasts, relative success of the Product and other relevant factors influencing such plans and activities. The JCC shall agree on the costs to be reimbursed in accordance with requests made under Section [*] (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply if any) and distribution strategy for such Product shared costs (if any) to be included in the Copromotion TerritoryCommercialization Plan with appropriate lead times for planning purposes, including budgeting and a mechanism for payment from one Party to the other Party. The Copromotion Territory By [*] of each calendar year starting on [*] or the Effective Date whichever is later, the JCC shall agree upon a proposed budget for reimbursable and/or shared costs (if any) for the following Astellas fiscal year. Astellas shall use good faith efforts to [*]. Annual updates shall be finally approved no later than [*] before the beginning of next calendar year. Once approved by the JCC, such revised Commercialization Plan shall be updated by replace the MSC at least once each calendar year such that it addresses no less than prior Commercialization Plan. (c) If the three (3) upcoming years. Not later than thirty (30) days after the filing terms of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on Commercialization Plan contradict, or before September 30 of each calendar yearcreate inconsistencies or ambiguities with, the MSC terms of this Agreement, then the terms of this Agreement 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 upcoming calendar year (the 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 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competitiongovern.

Commercialization Plan. On All Commercialization with respect to a Product by under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of such Product basisand the activities to be carried out with respect thereto, not later than sixty together with a proposed budget for such activities (60) days after each, a “Commercialization Plan”). The Parties, through the filing of the first application JSC, shall agree upon a preliminary Commercialization Plan for each Product at least ************ prior to anticipated Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for 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 TerritoryProduct. The Copromotion Territory A copy of each Commercialization Plan shall be updated by attached hereto as part of Exhibit C. During the MSC at least once Commercialization Phase with respect to each calendar year Product, the Parties, through the JSC, shall update the Commercialization Plan with respect to such that it addresses no less than Product on an annual basis prior to the three (3) upcoming years. Not later than thirty (30) days after the filing commencement of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each next calendar year, or more often as determined by the MSC shall prepare an annual commercialization plan and budget (the "Annual JSC. Each updated Commercialization Plan and Budget")shall include, which plan is based on for the then current Copromotion Territory Commercialization Plan and includes a comprehensive market developmentsubsequent ************, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder projection of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual plan for Commercialization Plan and Budget will 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, Activities for the Product in each country Territory and timelines for performing such activities, the projected Net Sales and other revenues from the sale of the Copromotion TerritoryProduct, together with an updated Commercialization budget. The Commercialization Plan shall contain an estimation of the resources that each Party intends to employ in connection with the Commercialization of the relevant Product. In addition, the JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and budgets for 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 Pre-Marketing Expenses, Net Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating other revenues, the Copromotion Territory JSC will revise the Commercialization Plan and each Annual 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 Budgetbudget 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 MSC will take into consideration factors such as market conditionspreceding Commercialization Plan (including, regulatory issues and competitionwithout limitation, all budget projections therein) shall remain in effect. The JSC shall not approve any Commercialization Plan that is inconsistent with or contradicts the terms of this Agreement.

Commercialization Plan. On a Product by Product basis, not No later than sixty (60) days after 12 months prior to the filing anticipated Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the first application for Regulatory Approval of a Product in the Copromotion Territory during the period beginning six (6) months prior to the anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”). The Commercialization Plan shall include information regarding planned Commercialization activities for Supplied Item in the Territory, the MSC shall prepare including, without limitation, pre-launch activities, establishment of government or private payor and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, salesreimbursement capabilities and pharmaceutical logistics capabilities, supply and distribution strategy for inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as market research to develop Product in positioning key messages). Cardiome may amend or update the Copromotion Territory. The Copromotion Territory Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall be updated by in any event provide SteadyMed with annual updates to the MSC at least once Commercialization Plan, in each calendar year such that it addresses no less than case, subject to the three (3) upcoming yearsrequirements of this Article 6. Not later than thirty (30) days after SteadyMed may provide comments and suggestions regarding the filing of the first application for Regulatory Approval of a Product in the 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"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 and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the Territory during each Quarter, which shall include such detail regarding the matters described in Sections 3.2(c), 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 upcoming calendar year (the 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 thereafterSections 3.2(c) through 3.2(g). The Annual Commercialization Plan and Budget will 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 the JSC may request or require or as market may be reasonably required for SteadyMed to assess Cardiome’s compliance with its obligations under Sections 6.3 and sales forecasts and related operating expenses, for the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition6.4.

Commercialization Plan. On a Product by Product basis, not No later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory[*], the MSC Astellas shall prepare and approve provide to the JCC for review and discussion a rolling multiyear (not less than three (3) years) written plan for Commercializing the Commercialization of such Collaboration Product in the Copromotion Territory an Astellas’ fiscal year (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 shall be updated by the MSC at least once each calendar year include a reasonably detailed description of and anticipated timeline for Astellas’, its Affiliates’ and sublicensees’ Commercialization activities with respect to such that it addresses no less than the three (3) upcoming yearsCollaboration Product, including, without limitation pre-launch plans, launch plans, market analytics, product forecasts, pricing assumptions and competitive intelligence. Not later than thirty (30) days after the filing of the first application If Cytokinetics exercises its Co-Promotion option for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar yearCollaboration Product, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan shall also include a reasonably detailed description of 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 anticipated timeline for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the 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 specify which Target Markets and distribution channels each Party shall devote its respective Cytokinetics’ Co-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, activities as well as market a budget therefor, which shall be consistent with Section 8.6 below. Astellas shall periodically (at least on an annual basis) prepare updates and sales forecasts amendments to its Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplaces and related operating expensesproduct forecasts, for the Product in each country relative success of the Copromotion Territory, Collaboration Products and budgets for projected Pre-Marketing Expenses, Sales other relevant factors influencing such plans and Marketing Expenses activities. Astellas shall submit all updates and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory amendments to its Commercialization Plan to the JCC for review and each Annual discussion. The Commercialization Plan and Budgetfor any Collaboration Product [*] must be agreed by the Parties. Astellas shall be solely responsible for all costs incurred by or on behalf of either Party in performing their respective obligations under the Commercialization Plan and, if Cytokinetics exercises its Co-Promotion option, shall pay Cytokinetics [*] determined by the MSC will take into consideration factors such JCC) for its Co-Promotion activities as market conditions, regulatory issues and competitionset forth in the Co-Promotion Agreement.

Commercialization Plan. On (a) The commercialization of each Collaboration Product shall be governed by a Product by Product basis, not later than sixty (60) days after Commercialization Plan which shall describe the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) overall plan for Commercializing commercializing such Product in the Copromotion Territory Collaboration Product, including (the "Copromotion Territory Commercialization Plan"), which plan includes i) a comprehensive market development, marketing, sales, supply pricing, distribution and distribution licensing strategy for such Collaboration Product in all applicable countries, including the Copromotion Territory. The Copromotion Territory Commercialization Plan shall Third Parties to be updated by utilized and the MSC at least once each calendar year such arrangements with them that it addresses no less than have been or are proposed to be agreed upon (including policies and procedures for adjustments, rebates, bundling and the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the 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"like), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development(ii) estimated launch date, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the 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 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 forecasts, in numbers of devices to be sold and related operating expenseslocal currency issues, and competitive analysis for such Collaboration Product, and (iii) a budget for the Commercialization Costs to be incurred in connection with performing such Commercialization Plan. (b) Upon the submission of all Regulatory Approval filings for a Collaboration Product in each country of any given country, NEUROMetrix shall develop and submit to the Copromotion Territory, Steering Committee for review and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory approval an initial Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take taking into consideration factors such as market conditions, regulatory issues factors, competition and competitionthe costs and profits of such Collaboration Product. NEUROMetrix shall be primarily responsible for developing each Commercialization Plan and, in connection therewith, shall consult with Cyberkinetics regarding the identification, timing and execution of and budget for the major commercialization tasks required to perform the Commercialization Plan, including without limitation the coordination of manufacturing with sales and marketing. Cyberkinetics shall be primarily responsible for developing a detailed manufacturing plan for each Collaboration Product, which plan shall be reviewed and approved by the Steering Committee and included within each Commercialization Plan. Cyberkinetics shall deliver such plan to NEUROMetrix within a reasonable period of time prior to the date NEUROMetrix expects to submit the overall Commercialization Plan to the Steering Committee. Each Commercialization Plan shall be updated annually by NEUROMetrix, in consultation with Cyberkinetics, and shall be submitted to the Steering Committee for approval not later than sixty (60) days prior to January 1 of each year. Each Commercialization Plan approved by the Steering Committee shall be signed by an authorized representative of each of Cyberkinetics and NEUROMetrix. (c) NEUROMetrix shall be primarily responsible for the implementation of each Commercialization Plan, including without limitation, setting all terms of sale, including establishing pricing policies, credit terms and cash discounts and allowances, formulating marketing plans, providing patient information, providing customer support services, providing reimbursement counseling services and sales force training; provided that NEUROMetrix's execution and performance in respect of its marketing and sale of Collaboration Products shall be consistent with the strategy, policies and procedures established by each Commercialization Plan. NEUROMetrix shall act as an agent of the Company in connection with the sale of Collaboration Products and all revenues from such sales shall be booked by the Company. NEUROMetrix shall use Commercially Reasonable and Diligent Efforts to conduct the activities described in each Commercialization Plan. Cyberkinetics shall use Commercially Reasonable and Diligent Efforts to perform any activities allocated to it under a Commercialization Plan and to provide such additional marketing support services as NEUROMetrix may from time to time reasonably request.

Commercialization Plan. On No later than [***] following Evelo notifying ALJ in writing that the first dose in the first patient of any Phase III Clinical Trial for a Product by Product basis, not later than sixty (60) days has occurred anywhere in the world after the filing Effective Date, ALJ will prepare: (a) a reasonably detailed written plan of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for 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 activities for such Product in the Copromotion TerritoryTerritory and submit such plan to the PCC 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”); and (b) a detailed, written budget of the Distribution Costs and other FTE Costs, Out-of-Pocket Expenses, Manufacturing Costs, and Other Operating Expenses expected to be incurred by or on behalf of each Party in the performance of such Commercialization activities on a Calendar Year basis (as may be updated pursuant to this Section 6.1 (Commercialization Plan), the “Commercialization Budget”). The Copromotion Territory Commercialization Plan shall will include all Commercialization activities to be updated undertaken by each Party for the MSC at Products in the Territory and an allocation between the Parties for all such activities (including, in the case of Evelo, manufacturing of the API for each Product). At least once each calendar year such that it addresses no less than Calendar Year, ALJ will provide to the three (3) upcoming years. Not later than thirty (30) days after PCC an update to the filing of the first application for Regulatory Approval of a Product in the 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 then-current Commercialization Plan and Commercialization Budget"), which plan is based on and may provide additional updates thereto from time to time, and the then current Copromotion Territory PCC will review, discuss, and determine whether to approve any proposed amendments or updates to the Commercialization Plan and includes (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 a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts Commercialization activity already contemplated in the upcoming calendar year (Commercialization Plan, and the first PCC does not agree to such Annual Development Plan and amendment to the Commercialization Budget shall cover the remainder of the calendar year in which for such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels activity, each Party shall devote be relieved of its respective Promotion efforts towardsobligations 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 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, Term. ALJ will not perform any Commercialization activities for the Product Products for the Territory other than in each country of accordance with the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competitionPlan.

Commercialization Plan. On a Product by Product basisThe strategy and budget for the Commercialization of, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve Territory will be described in a rolling multiyear (not less than three (3) years) comprehensive plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory “Commercialization Plan"), which plan includes ”) and in a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the 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 “Incremental Cost Budget"”), which plan is each developed by EPI Health based on good faith assumptions regarding the then 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 upcoming calendar year (the 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 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, forecast for the Product in each country of the Copromotion Field in the Territory, in consultation with MC2, and budgets 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 projected Prenon-Marketing Expensesinventory and non-personnel costs, Sales provided that 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 Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory 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 each Annual 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 under this Agreement and shall specifically describe the (a) Commercialization activities for the Product in the Territory (including messaging, branding, list price and rebating strategy, pricing, advertising, education, planning, marketing, promotion, product sampling and sales force training and allocation), (b) key tactics for implementing those activities, (c) specific resource commitments required of the Parties, including number and location of EPI Sales Territories, number of EPI Health Sales Representatives, number of Details by position, and marketing spend, (d) the Field Force Detailing Plan, (e) a three (3)-year sales forecast and (f) any other information necessary or useful for the successful Commercialization of the Product in the Field in the Territory. In the event of any inconsistency between either the Commercialization Plan or Incremental Cost Budget, on the MSC will take into consideration factors such as market conditionsone hand, regulatory issues and competitionthis Agreement, on the other hand, the terms of this Agreement shall govern and control. Notwithstanding anything to the contrary in this Agreement, the Commercialization Plan shall specify and account for the performance of EPI Commercialization Activities by EPI Health and MC2 Commercialization Activities by MC2. In no event shall EPI Health be required to perform any function or activity or to purchase inventory set forth in the Commercialization Plan the cost of which is not covered by the then-current Incremental Cost Budget.

Commercialization Plan. On a Product by Collaboration Product-by-Collaboration Product basis, not later than sixty (60) days [***] after the filing commencement of the first application for Regulatory Approval Phase III Clinical Trial of a Product R&D Candidate in the Copromotion Territory, the MSC ELAN shall prepare and approve a the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multiyear multi-year (being not less than three (3) yearsthan[***]) plan for Commercializing such the Collaboration 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 Territoryshall include without limitation [***]. The Copromotion Territory Commercialization Plan shall be updated by the MSC ELAN at least once each calendar year such that it addresses no less than the three (3) upcoming yearsyear. Not later than thirty (30) days [***] after the filing of the first application BLA for Regulatory Approval of a Product an R&D Candidate in the Copromotion Territory and thereafter on or before September 30 August 31 of each calendar year, the MSC ELAN shall prepare an annual commercialization and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan and budget (the "Annual Commercialization Plan and BudgetPost BLA Filing Plan"), which plan is shall be based on and shall supersede 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 upcoming calendar year (the first such Annual Development Plan and which shall include [***]. The Post BLA Filing Budget shall cover be based on and shall supersede the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter)relevant Commercialization Budget. The Annual Commercialization Post BLA Filing Plan and Budget will 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Annual Commercialization Plan and Post BLA Filing Budget, the MSC 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 [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the 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 that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis thereto.

Commercialization Plan. On a Product by Product basis, not Commencing no later than sixty (60) days after []* prior to the filing anticipated launch of the first application for Regulatory Approval 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 Copromotion TerritoryProfit-Share Territory in the next Calendar Year and the dates by which such activities are targeted to be accomplished (each, a “Commercialization Plan”). The Commercialization Plan (including the MSC budget) shall prepare contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the Commercialization Plan, and the JCT shall approve a rolling multiyear (not less the first Commercialization Plan for the Profit-Share Territory no later than three (3) years) plan for Commercializing such []* prior to launch of the first Licensed Product in the Copromotion Territory (Profit-Share Territory. Thereafter, the "Copromotion Territory JCT shall review the Commercialization 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, which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy including any budgets for such Product the Profit-Share Territory contained in the Copromotion Territory. The Copromotion Territory Commercialization Plan Plan, shall not be updated by effective without the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing approval of the first application for Regulatory Approval of JCT. Notwithstanding anything in this Agreement to the contrary, if Cubist engages or uses a Product Third Party to perform any Commercialization activities in the Copromotion Profit-Share Territory and thereafter on under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or before September 30 of each calendar yearwhere there will be a material penalty for early termination that is inconsistent with industry standards, 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 upcoming calendar year (the 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 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition[]*.

Commercialization Plan. On All Commercialization of the 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 Promotion of the Product by Product basisin the Field in the Territory in accordance with Applicable Laws and the activities to be carried out related thereto (the “Commercialization Plan”). The Parties have agreed upon a high-level outline of the Commercialization Plan, not as further described on Exhibit 6.2. No later than sixty ninety (6090) days after the filing 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 application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for 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 updated Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not and not later than thirty ninety (3090) days after the filing Effective Date, United Therapeutics shall submit the first annual updated Commercialization Plan to the JSC prior to the start of the first application for Regulatory Approval of a second Calendar Year (i.e., prior to January 1, 2010). If Lilly determines that such updated Commercialization Plan does not comply with Applicable Laws, including laws relating to promotional and advertising materials as well as accepted industry standards and Lilly’s ethical policies, in each case with respect to the Product in the Copromotion Territory Field in the Territory, or that the activities conducted under such updated Commercialization Plan are reasonably likely to materially adversely affect products in Lilly’s Domain, Lilly shall be permitted to propose, in good faith, revisions to such updated Commercialization Plan, and thereafter on or before September 30 United Therapeutics shall revise such Commercialization Plan. In the event of each calendar year, any inconsistency between 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 upcoming calendar year (the 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 specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towardsthis Agreement, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning terms of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competitionthis Agreement shall prevail.

Commercialization Plan. On Cipla will be responsible for preparing and presenting to the JSC a Product by Product basis, not later than sixty Commercialization Plan twelve (6012) days after months prior to the filing of the first application for anticipated Regulatory Approval of a the Product for marketing in the Copromotion TerritoryU.S. or in any other country in the Territory in connection with the Pulmonary Indication. Following JSC review and approval of such Commercialization Plan, the MSC JSC shall review the implementation and execution of 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 greater, 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 each June 30th thereafter, Cipla, will prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in present to 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 JSC an updated Commercialization Plan shall be updated for the 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 MSC at least once each calendar year such event that it addresses no less the Product receives Regulatory Approval for a Pulmonary Indication in any country other than the three (3) upcoming years. Not later than U.S., the JSC shall make a determination if the Product will be Commercialized in such jurisdiction within thirty (30) days after the filing of the first application for such Regulatory Approval of a Product in and, if the 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 upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated JSC so determines to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will 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 Commercialize the Product in each country of such jurisdiction, then Cipla shall prepare and present Commercialization Plans (including annually updated Commercialization Plans) for such jurisdiction following the Copromotion Territory, and budgets same procedure set forth above for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.U.S.

Commercialization Plan. On a Product by Product basis, not later than sixty (60a) days after Without limiting the filing generality of Auxilium’s sole responsibility and decision-making authority for Commercializing the first application for Regulatory Approval of a Product in the Copromotion TerritoryField in the Auxilium Territory as set forth in Section 4.2, Auxilium will use its Commercially Reasonable Efforts to carry out the MSC shall prepare and approve Commercialization of the Product in accordance with a rolling multiyear (not less than three (3) years) plan for Commercializing written Commercialization Plan, as such may be amended or revised by Auxilium from time to time, that describes the anticipated Commercialization activities to be performed with respect to Product in the Copromotion Auxilium Territory by Auxilium or on its behalf by permitted Third Parties (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 Each Commercialization Plan shall address, in reasonable detail, to the extent applicable, call plans for Detailing of Product, Sales Force training, Product sampling strategies and quantities, Product positioning and scientific communication strategy, and DTC and non-DTC advertising. (b) Attached hereto as Exhibit A is a Commercialization Plan covering activities to be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing conducted in preparation of the first application for Regulatory Approval of a Product Launch in the Copromotion Auxilium 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 upcoming calendar year (the 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 during the first full calendar year thereafter). The Annual following the Product Launch. (c) Auxilium shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Auxilium shall provide the JSC with preliminary drafts of the Commercialization Plan and Budget will specify which Target Markets Medical Affairs Plan no later than *** of each year for the JSC’s review and distribution channels each Party comment and Auxilium shall devote its respective Promotion efforts towardsprovide the JSC with the final Commercialization Plan and Medical Affairs Plan no later than *** of the year immediately following such year. In preparing the updated versions of the Commercialization Plan and Medical Affairs Plan, Auxilium shall analyze the personnel effectiveness of the elements of the prior year Commercialization Plan and other resources to be devoted by each Party to such efforts, the number Medical Affairs Plan and positioning of Details to be performed by each Party, as well as market and shall use updated sales forecasts to develop the new Commercialization Plan. Auxilium agrees to give due consideration to the input provided by the JSC but Auxilium at all times will retain responsibility and related operating expenses, decision-making authority for the Commercialization of the Product in each country of the Copromotion Field in the Auxilium Territory. Auxilium may, and budgets for projected Pre-Marketing Expensesat its election, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating update the Copromotion Territory Commercialization Plan and each Annual Medical Affairs Plan between annual updates by following this same procedure. (d) Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan and BudgetMedical Affairs Plan. (e) In the event of any inconsistency between, on the one hand, the MSC will take into consideration factors such as market conditionsCommercialization Plan or Medical Affairs Plan and, regulatory issues and competitionon the other hand, this Agreement, the terms of this Agreement shall prevail.

Commercialization Plan. On a Product by Product basis, not Commencing no later than sixty (60) days after [**] prior to the filing anticipated launch of the first application for Regulatory Approval 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 Copromotion TerritoryProfit-Share Territory in the next Calendar Year and the dates by which such activities are targeted to be accomplished (each, a “Commercialization Plan”). The Commercialization Plan (including the MSC budget) shall prepare contain sufficient detail with respect to Commercialization tactics and other matters to enable the JCT to conduct a meaningful review of the Commercialization Plan, and the JCT shall approve a rolling multiyear (not less the first Commercialization Plan for the Profit-Share Territory no later than three (3) years) plan for Commercializing such [**] prior to launch of the first Licensed Product in the Copromotion Territory (Profit-Share Territory. Thereafter, the "Copromotion Territory JCT shall review the Commercialization 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 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, which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy including any budgets for such Product the Profit-Share Territory contained in the Copromotion Territory. The Copromotion Territory Commercialization Plan Plan, shall not be updated by effective without the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing approval of the first application for Regulatory Approval of JCT. Notwithstanding anything in this Agreement to the contrary, if Cubist engages or uses a Product Third Party to perform any Commercialization activities in the Copromotion Profit-Share Territory and thereafter on under circumstances where such Third Party will be granted a sublicense under Alnylam Technology or before September 30 of each calendar yearwhere there will be a material penalty for early termination that is inconsistent with industry standards, 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 upcoming calendar year (the 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 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition[**].

Commercialization Plan. On a Product by Product basis, not later than sixty (60a) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC The JCC shall prepare develop and approve a rolling multiyear (not less than three (3) years) multi-year plan and budget for Commercializing such commercializing the 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 shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the 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 include a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the 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)year. The Annual Commercialization Plan and Budget will specify which Target Markets Populations and distribution channels each Party shall devote its respective Co-Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Commercialization Expenses and Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and BudgetPlan, the MSC JCC will take into consideration factors such as market conditions, regulatory issues and competition. The Commercialization Plan will include the general strategy and operating guidelines for the commercialization of the Product. (b) It is the intention of the Parties that Aviron's sales and marketing organization shall concentrate on a specific market segment or segments, to be agreed upon by the JCC, and that Aviron's marketing efforts shall include the development of an electronic-based selling infrastructure to support sales of the Product. It is also the intention of the Parties that, assuming regulatory approval therefor, Wyeth-Ayerst shall focus its initial sales and marketing efforts of the Product to the healthy pediatric Target Population, giving the Product first detail position for the Flu Season in which occurs the Launch Date. Further, the Parties intend that, if the Product is approved in the Field in the Territory for the adult Target Population, then Wyeth-Ayerst shall provide (including hiring, if necessary) sufficient personnel in its sales and marketing organization to market and sell the Product to such adult Target Population. (c) The first Commercialization Plan shall be prepared and approved as promptly as possible after the Effective Date and shall thereafter be immediately in effect. Annually thereafter, the JCC shall update and amend the Commercialization Plan with such process as the JCC shall determine. [***] = CONFIDENTIAL TREATMENT REQUESTED.

Commercialization Plan. On a Product by Product basis, not No later than sixty (60) days after 12 months prior to the filing anticipated Launch Date, Cardiome shall prepare and deliver to SteadyMed for review a reasonably detailed written plan for the Commercialization of the first application for Regulatory Approval of a Product in the Copromotion Territory during the period beginning six (6) months prior to the anticipated Launch Date and ending on the fifth (5th) anniversary thereof (the “Commercialization Plan”). The Commercialization Plan shall include information regarding planned Commercialization activities for Supplied Item in the Territory, the MSC shall prepare including, without limitation, pre-launch activities, establishment of government or private payor and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, salesreimbursement capabilities and pharmaceutical logistics capabilities, supply and distribution strategy for inventory-related activities, Promotion, anticipated number and geographic distribution/coverage of Sales Representatives by country, and Sales Force and tactical marketing activities (such as market research to develop Product in positioning key messages). Cardiome may amend or update the Copromotion Territory. The Copromotion Territory Commercialization Plan from time to time to reflect changes in Cardiome’s Commercialization plans, and shall be updated by in any event provide SteadyMed with annual updates to the MSC at least once Commercialization Plan, in each calendar year such that it addresses no less than case, subject to the three (3) upcoming yearsrequirements of this Article 6. Not later than thirty (30) days after SteadyMed may provide comments and suggestions regarding the filing of the first application for Regulatory Approval of a Product in the 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"any amendment or update thereto to Cardiome, and C▇▇▇▇▇▇▇ 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 and efforts conducted by or on behalf of Cardiome and its Affiliates for Supplied Item in the Territory during each Quarter, which shall include such detail regarding the matters described in Sections 3.2(c), 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 upcoming calendar year (the 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 thereafterSections 3.2(c) through 3.2(g). The Annual Commercialization Plan and Budget will 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 the JSC may request or require or as market may be reasonably required for SteadyMed to assess Cardiome’s compliance with its obligations under Sections 6.3 and sales forecasts and related operating expenses, for the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition6.4.

Commercialization Plan. On a Product by Product basisWhile Vifor shall be responsible for preparing the Commercialization Plan, not later than sixty the JCC (60using appropriate experts within each Party’s organization) days after shall have the filing of right and be responsible for discussing and approving the first application initial Commercialization Plan, which sets forth in reasonable detail the tasks, timeline and budget for Regulatory Approval of a Commercialization activities for the Licensed Product in the Copromotion TerritoryField in the United States, and for discussing, and approving on an annual basis (or, if needed, on an interim basis) all subsequent updates, amendments and modifications to the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan Commercialization Plan, as reasonably needed or appropriate for Commercializing such the Commercialization of Licensed Product in the Copromotion Territory Field in the United States consistent with this Agreement. Vifor (and its applicable Affiliates and Sublicensees) shall conduct Commercialization activities for the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Licensed Product in the Copromotion TerritoryField in the United States in accordance with the approved Commercialization Plan. The Copromotion Territory Commercialization Plan shall set forth the tasks to be updated undertaken by (or on behalf of) Vifor for Commercialization activities for the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Licensed Product in the Copromotion Territory Field in the United States (including coordination with VFMCFP promotional activities to FMC US Dialysis Clinics), including budgets for all such Commercialization activities, the marketing and thereafter advertising plans, the specific commitments for the numbers of “Primary Detail Equivalents” for the Vifor (or VFMCRP, as applicable) sales representatives to conduct on or before September 30 of each Licensed Product in the applicable calendar year, and annual projections for Net Sales of Licensed Products in the MSC shall prepare an annual commercialization plan and budget (U.S. for the "Annual coming year. From time to time, either Party may propose amendments or modifications to the Commercialization Plan and Budget"), which plan is as needed based on the then current Copromotion Territory progress or results of the Commercialization Plan and includes a comprehensive market developmentof Licensed Products, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts and/or changes in the upcoming calendar year (U.S. market for Licensed Products in the 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 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 the Product in each country of the Copromotion TerritoryField, and budgets in such case the JCC shall review in good ​ ​ faith and comment on the proposed amendments or modifications, and if the JCC agrees, shall subject the agreed amendments or modifications to the JCC for projected Pre-Marketing Expensesreview and comment and, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budgetif acceptable, the MSC will take into consideration factors such as market conditions, regulatory issues and competitionapproval.

Commercialization Plan. On a Product by Product-by-Product basis, not later than sixty (60) days after *** the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC JSC shall prepare and approve a rolling multiyear (not less than three (3) years( *** ) plan for 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 shall be updated by the MSC JSC at least once each calendar year such that it addresses no less than the three (3) upcoming years*** . Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC JSC shall prepare an annual commercialization plan and budget (the "“Annual Commercialization Plan and Budget"Plan”), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, customer support, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Commercialization 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 specify which Target Markets 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 Copromotion 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-Post- Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and BudgetPlan, the MSC JSC will take into consideration 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 Assigned Sales Force Effort.

Commercialization Plan. On a Product The JCC will oversee the Commercialization of Products 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 Product basis, not 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 sixty (60) days after twelve months prior to the filing of the anticipated first application for Regulatory Approval commercial launch of a Product in the Copromotion first country in the Territory, the MSC shall prepare JCC, will develop and approve submit to the JSC for approval, a rolling multiyear Commercialization plan (not less than three (3as may be amended, the “Commercialization Plan”) years) plan for Commercializing that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of 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 Field in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by In allocating responsibilities between the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar yearParties, 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 upcoming calendar year (the 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 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC JCC will take into consideration factors 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 market conditionsdetermined 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, regulatory issues (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and competitionexhibitions 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 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 Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”).

Commercialization Plan. On All Commercialization with respect to a Product by under this Agreement shall be conducted pursuant to a Commercialization Plan, which shall set forth the plan for the Commercialization of such Product basisand the activities to be carried out with respect thereto, not later than sixty together with a proposed budget for such activities (60) days after each, a “Commercialization Plan”). The Operating Parties, through the filing JSC, shall agree upon a preliminary Commercialization Plan for each Product at least ************ prior to the anticipated Regulatory Approval for such Product. During the Commercialization 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 first application for Regulatory Approval of a Product in next calendar year, or more often as determined by the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for 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 TerritoryJSC. The Copromotion Territory Each updated Commercialization Plan shall be updated by include, for the MSC at least once each calendar year such that it addresses no less than subsequent ************, the three (3) upcoming years. Not later than thirty (30) days after the filing projection of the first application plan for Regulatory Approval of a Product in the 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 upcoming calendar year (the 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 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, Activities for the Product in each country Territory and timelines for performing such activities, the projected Net Sales and other revenues from the sale of the Copromotion TerritoryProduct, together with an updated Commercialization budget. The Commercialization Plan shall contain an estimation of the resources that each Operating Party intends to employ in connection with the Commercialization of the relevant Product. In addition, the JSC will review performance against the Commercialization Plan for each Product on a quarterly basis, and budgets for 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 Pre-Marketing Expenses, Net Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating other revenues, the Copromotion Territory JSC will revise the Commercialization Plan and each Annual 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 Budgetbudget 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 MSC will take into consideration factors such as market conditionspreceding Commercialization Plan (including, regulatory issues and competitionwithout limitation, all budget projections therein) shall remain in effect. The JSC shall not approve any Commercialization Plan that is inconsistent with or contradicts the terms of this Agreement.

Commercialization Plan. On a Product by Product basis, not later than sixty (60a) days after Without limiting the filing generality of Licensee’s sole responsibility and decision-making authority for Commercializing the first application for Regulatory Approval of a Product in the Copromotion TerritoryField in the Licensee Territory as set forth in Section 4.2, Licensee will use its Commercially Reasonable Efforts to carry out the MSC shall prepare and approve Commercialization of the Product in accordance with a rolling multiyear (not less than three (3) years) plan for Commercializing written Commercialization Plan, as such may be amended or revised by Licensee from time to time, that describes the anticipated Commercialization activities to be performed with respect to Product in the Copromotion Licensee Territory by Licensee or on its behalf by permitted Third Parties (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 Each Commercialization Plan shall be updated by address, in reasonable detail, to the MSC at least once each calendar year such that it addresses no less than the three extent applicable, call plans for Detailing of Product, Sales Force training, Product sampling strategies and quantities, Product positioning and scientific communication strategy, and DTC and non-DTC advertising. (3b) upcoming years. Not later than Within thirty (30) days after the filing of the first application for Regulatory Approval Effective Date, Licensee shall deliver to VIVUS a Commercialization Plan covering activities to be conducted in preparation of a any Product Launch in the Copromotion Licensee Territory on a country-by-country basis 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 upcoming calendar year (the 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 during the first full calendar year thereafter). The Annual following such Product Launch. (c) Licensee shall thereafter update the Commercialization Plan (together with the Medical Affairs Plan described in Section 4.7) on an annual basis as follows: Licensee shall provide the JSC (or VIVUS in the absence of a JSC) with preliminary drafts of the Commercialization Plan and Budget will specify which Target Markets Medical Affairs Plan no later than November 15 of each year for the JSC’s (or VIVUS’ in the absence of a JSC) review and distribution channels each Party comment and Licensee shall devote its respective Promotion efforts towardsprovide the JSC (or VIVUS in the absence of a JSC) with the final Commercialization Plan and Medical Affairs Plan no later than January 31 of the year immediately following such year. In preparing the updated versions of the Commercialization Plan and Medical Affairs Plan, Licensee shall analyze the personnel effectiveness of the elements of the prior year Commercialization Plan and other resources to be devoted by each Party to such efforts, the number Medical Affairs Plan and positioning of Details to be performed by each Party, as well as market and shall use updated sales forecasts to develop the new Commercialization Plan. Licensee agrees to give due consideration to the input provided by the JSC (or VIVUS in the absence of a JSC) but Licensee at all times will retain responsibility and related operating expenses, decision-making authority for the Commercialization of the Product in each country of the Copromotion Field in the Licensee Territory. Licensee may, and budgets for projected Pre-Marketing Expensesat its election, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating update the Copromotion Territory Commercialization Plan and each Annual Medical Affairs Plan between annual updates by following this same procedure. (d) Each Party shall use Commercially Reasonable Efforts in performing its obligations under this Section 4.3 concerning (as applicable) the Commercialization Plan and BudgetMedical Affairs Plan. (e) In the event of any inconsistency between, on the one hand, the MSC will take into consideration factors such as market conditionsCommercialization Plan or Medical Affairs Plan and, regulatory issues and competitionon the other hand, this Agreement, the terms of this Agreement shall prevail.

Commercialization Plan. On a Product by Collaboration Product-by-Collaboration Product basis, not later than sixty (60) days [***] after the filing commencement of the first application for Regulatory Approval Phase III Clinical Trial of a Product R&D Candidate in the Copromotion Territory, the MSC ELAN shall prepare and approve a the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept ELAN's rolling multiyear multi-year (being not less than three (3) yearsthan[***]) plan for Commercializing such the Collaboration 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 Territoryshall include without limitation [***]. The Copromotion Territory Commercialization Plan shall be updated by the MSC ELAN at least once each calendar year such that it addresses no less than the three (3) upcoming yearsyear. Not later than thirty (30) days [***] after the filing of the first application BLA for Regulatory Approval of a Product an R&D Candidate in the Copromotion Territory and thereafter on or before September 30 August 31 of each calendar calen dar year, the MSC ELAN shall prepare an annual commercialization and the JSC shall review, and after due consideration by ELAN of any suggestions or comments, accept a long term plan and budget (the "Annual Commercialization Plan and BudgetPost BLA Filing Plan"), which plan is shall be based on and shall supersede 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 upcoming calendar year (the first such Annual Development Plan and which shall include [***]. The Post BLA Filing Budget shall cover be based on and shall supersede the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter)relevant Commercialization Budget. The Annual Commercialization Post BLA Filing Plan and Budget will 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 the 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 preparing and updating the Copromotion Territory Commercialization Plan, Commercialization Budget, each Post BLA Filing Plan and each Annual Commercialization Plan and Post BLA Filing Budget, the MSC 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 [***] (the "Post BLA Excess Charge"). All expenses incurred by the Parties in respect of any Post BLA Filing Budget and charged to their respective R&D Accounts shall be shared equally by the 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 that year in respect of the then current Post BLA Filing Budget, pay to ELAN [***] of any Post BLA Excess Charges charged by ELAN to is R&D Account in each Post BLA Excess Year provided always that CAT's liability hereunder in any year shall not exceed [***] of [***] of the relevant Post BLA Filing Budget. If CAT's liability hereunder in any year does exceed [***] of [***] of the relevant Post BLA Filing Budget then this Section shall apply mutatis mutandis thereto.