Joint Commercialization Plan Sample Clauses

Joint Commercialization Plan. Biogen Idec shall prepare the strategic elements of the first Joint Commercialization Plan prior to Sobi’s exercise of the Opt-In Right. Following Opt-In, the Parties shall use Commercially Reasonable Efforts to develop the operational FOIA EXEMPTION CLAIMED AND PRIOR NOTIFICATION REQUESTED BEFORE ANY DISCLOSURE Execution Version elements, and further refine or amend the strategic elements, of the Joint Commercialization Plan, within sixty (60) days of Opt-In. Prior to [**] of each year, the JCC shall update and the JSC shall approve the Joint Commercialization Plan covering Commercialization activities for each Product. The JCC may, from time to time, amend or modify the then-current Joint Commercialization Plans. Each Joint Commercialization Plan shall contain sufficient details for each Party to conduct its typical budgeting activities. For avoidance of doubt, each Joint Commercialization Plan shall specify all of the Commercialization Activities of each Party, whether to be conducted individually or jointly by the Parties, and shall specify which, if any, of such Commercialization Activities are Additional Agreed Activities. Notwithstanding anything to the contrary in this Agreement, any Joint Commercialization Plan prepared by Biogen Idec prior to Opt-In shall not be binding on Sobi to conduct any activities, or be responsible for any portion of any costs incurred, after the exercise of its Opt-In Right for a Product, except to the extent such Joint Commercialization Plan is confirmed by the JCC or JSC after Opt-In.
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Joint Commercialization Plan. (i) As further described in this Section 8.3, the tactics and strategy for the Commercialization of each Product in the Territory will be described in a comprehensive plan (each such plan, a “Joint Commercialization Plan”) that describes the pre-launch, launch and subsequent Commercialization of such Product in the Shared Territory (including anticipated activities relating to messaging, branding, Pricing Matters (to the extent not prohibited by Applicable Law), advertising, planning, marketing, sales force training and allocation, detailing, and Distribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a “Joint Commercialization Budget”).
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Joint Commercialization Plan. Any expenses incurred by a Party for Commercialization activities in the Shared Territory related to a Product that do not fall within the definitions of Joint Commercialization Costs will be borne solely by such Party unless the JCC determines otherwise. In addition, any expenditure or cost that exceeds the amount set forth in the applicable Joint Commercialization Plan by more than [***] for a calendar year or any unbudgeted cost that is incurred by either Party will be borne by such Party; provided that the JCC will have the discretion to review such expenditures or costs and propose to the JSC that they be designated as Joint Commercialization Costs.
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Joint Commercialization Plan. (a) As further described in this Section 6.2, the tactics and strategy for the Commercialization of each Product in the Shared Territory shall be described in a comprehensive plan (each such plan, a “Joint Commercialization Plan”) that describes the pre-launch, launch and subsequent Commercialization of such Product in the Shared Territory (including without limitation anticipated activities relating to messaging, branding, Pricing Matters, advertising, planning, marketing, sales force training and allocation, and Distribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a “Joint Commercialization Budget”). If Astellas believes any individual Commercialization Cost that it expects or plans to incur with respect to the Licensed Territory will also reasonably benefit the Shared Territory, Astellas may propose that a portion of such Commercialization Cost be allocated in the applicable Joint Commercialization Budget to the Shared Territory, and Medivation shall consider that request reasonably and in good faith. No such Commercialization Cost may be allocated in whole or in part to the Shared Territory without the express written consent of Medivation (it being understood that each of the Parties shall be deemed to have consented expressly in writing that any such Commercialization Costs included as part of the Joint Commercialization Budget be allocated to the Shared Territory to the extent appearing in such budget).
Sample 1
Joint Commercialization Plan. (i)The Parties shall agree on a comprehensive joint product plan for Licensed Products in the Shared Territory (the “Joint Commercialization Plan”), which shall include [***] (the, “Joint Commercialization Budget”). Notwithstanding the foregoing, the initial Joint Commercialization Plan (including the initial high-level Joint Commercialization Budget [***]), which includes a forecasted profit and loss plan [***] based on initial product plan activities for the Lead Product during such period, is attached hereto as Exhibit H. ​ ​ ​
Sample 1
Joint Commercialization Plan. The JDC shall determine a target filing date of the BLA for the most advanced Licensed Product being Developed under this Agreement (the “Target BLA Filing Date”). No later than [***] of a Licensed Product in the Profit-Sharing Territory, GSK will provide to the JCC a draft initial joint commercialization plan and budget that sets out the Commercialization and Medical Affairs activities to be conducted by the Parties with respect to the Licensed Products in the Profit-Sharing Territory (the “Joint Commercialization Plan”). The Joint Commercialization Plan will be based upon and consistent with the Global Strategic Launch Plan for the applicable Licensed Product. Promptly thereafter, the JCC, with the support and direct involvement of the Financial Working Group with regard to preparation of the Joint Commercialization Budget, will review, discuss and recommend modifications to the draft Joint Commercialization Plan (provided, that only the medical representatives on the JCC may recommend modifications to the Medical Affairs activities set forth in the Joint Commercialization Plan), and the JCC will, in turn, provide such Joint Commercialization Plan (as such plan may be modified on the recommendation of the JCC) and Joint Commercialization Budget to the JSC to review, discuss and determine whether to approve. The Joint Commercialization Plan will (a) include matters similar to those included in the Global Strategic Launch Plan but revised to specifically support launch of the Licensed Product in the Profit-Sharing Territory, (b) [***] included in such plan to be undertaken for the upcoming Calendar Year which budget will be broken down by Calendar Quarter, for the estimated Commercial FTE Costs (for Commercialization activities), estimated Development FTE Costs (for Medical Affairs activities), Manufacturing Costs, and Out-Of-Pocket Costs expected to be incurred by each Party in the given Calendar Year with respect to such Medical Affairs and Commercialization activities set forth in such plan (such budget the “Joint Commercialization Budget”). So long as ITEOS is Commercializing with GSK the Licensed Products in the Profit-Sharing Territory under this Agreement, on at least an annual basis during the Term (or more frequently as may be required), GSK will review and update each Joint Commercialization Plan (and Joint Commercialization Budget therein) based on the currently available information and data. GSK will provide to the JCC a copy of each such upda...
Sample 1
Joint Commercialization Plan. The initial joint Commercialization plan (“Joint Commercialization Plan”) and the budget contained therein shall be the Commercialization plan and budget most recently provided by Takeda to Alnylam pursuant to Section 4.2(b). From time to time as may be reasonably necessary, Takeda shall have the right, in its sole reasonable discretion, to modify a Joint Commercialization Plan after consultation with Alnylam and giving good faith consideration to any reasonable comments or suggestions by Alnylam, including as to the allocation of responsibilities of the Parties as set forth in Section 7 below. Any material changes to the timeline or budget for the Commercialization of a Shared Product as such are set forth in the initial or any subsequently agreed Joint Commercialization Plan which (i) are reasonably likely to delay the commercial launch of the Shared Product by more than [**] or (ii) will increase the applicable Commercialization budget by more than [**] percent ([**]%) of the most recent applicable Commercialization budget for such Shared Product shall require the mutual agreement of the Parties: provided, however, that if Takeda pays the amount that exceeds [**] percent ([**]%) of the Commercialization budget, such requirement of item (ii) above (mutual agreement) will not apply.
Sample 1
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Joint Commercialization Plan. (i) No later than [**] prior to the anticipated first Regulatory Approval in the Shared Territory for a Licensed Product, the Parties shall, through the JCC, prepare and submit to the JSC for approval a detailed Commercialization plan for such Licensed Product in the Territory (the “Joint Commercialization Plan”), which shall include on a Calendar Year basis (with such Calendar Year plan segmented by Calendar Quarters within each Calendar Year) for [**], the pre-launch, launch and subsequent Commercialization of any Licensed Product in the Shared Territory, including First Commercial Sale preparation and pre-First Commercial Sale market development activities for such Licensed Product in the Field in the Shared Territory, Commercialization activities and the respective roles and responsibilities of each Party in connection with such activities, each Party’s sales forecasts, global pricing strategies, Manufacturing for Commercialization, key tactics and strategies for implementing those Commercialization activities, general marketing and promotional plans for such Product in the Shared Territory (including selection and prosecution of the Product Marks), the targeted level of promotion effort for each Licensed Product, including the number of Details, overall targeting strategy and approach for prescribers and organized customers (e.g., medical groups, integrated delivery networks, hospitals), for the Calendar Year(s) covered by the applicable Commercialization Plan, sales forces, use of Distributors, and the associated budget for the foregoing Commercialization activities for the remainder of [**] (the “Joint Commercialization Budget”) and a good faith forecast for the [**].
Sample 1

Related to Joint Commercialization Plan

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

  • Commercialization 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.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Development Plan As defined in Section 3.2(a).

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

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