Shared Territory Commercialization Plan Sample Clauses

Shared Territory Commercialization Plan. As further described in this Section 6.2, the strategy for the pre-launch, commercial launch, and subsequent Commercialization of the applicable Optioned Product in the Shared Territory shall be described in a comprehensive plan (each such plan, a “Shared Territory Commercialization Plan”) that describes at a high level the Commercialization activities anticipated to be conducted for such Optioned Product in the Shared Territory and includes an estimate of corresponding Allowable Expenses (each a “Commercial Budget”).
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Shared Territory Commercialization Plan. (A) As further described in this Section 5.2(b)(ii), the tactics and strategy for the Commercialization of each Licensed Product in the Shared Territory shall be described in a comprehensive plan (each such plan, a “Shared Territory Commercialization Plan”), prepared by Gilead, that describes […***…] (each such included budget, a “Shared Territory Commercialization Budget”). The Shared Territory Commercialization Plan shall include a detailed description of the Co-Promotion activities to be undertaken in the Shared Territory with respect to the Licensed Product or, as applicable, the Gilead Combination Product during the following calendar year, and shall allocate the responsibilities of the Parties for the Co-Promotion activities under the plan (such allocation, the “Co-Promotion Plan”) (it being understood that Galapagos shall be assigned to perform that proportion of Co-Promotion activities in the Co-Promotion Plan that equals the Galapagos Promotional Share for each respective country in the Shared Territory). The Shared Co-Promotion Plan shall not allocate Co-Promotion activities in a manner that results in Sales Representatives of both Parties Detailing Licensed Products or as applicable, the Gilead Combination Product to the same physicians, health care practitioners permitted by law to prescribe Licensed Products or non-prescribing health care practitioners. Each Shared Territory Commercialization Plan shall be consistent with the requirements of the applicable Global Commercialization Strategy, as such Global Commercialization Strategy may be updated from time to time.
Sample 1
Shared Territory Commercialization Plan. As further described in this Section 5.2, the strategy for the commercial launch of, and subsequent Commercialization of, each Product in the Shared Territory shall be described in a comprehensive plan (each such plan, including the Initial Shared Territory Commercialization Plan, and any revisions thereto, a “Shared Territory Commercialization Plan”) that describes the (a) pre-launch, launch and subsequent Commercialization activities for such Product in the Shared Territory (including without limitation messaging, branding, pricing, advertising, education, planning, marketing, sales force training and allocation), (b) key tactics for implementing those activities, (c) the relative responsibilities of the Parties, (d) Field Force Detailing Plan, and (e) the commercialization budget for such Product in the Shared Territory (each such budget, including the Initial Shared Territory Commercialization Budget, and any revisions thereto, a “Shared Territory Commercialization Budget”). Notwithstanding the preceding sentence, a high-level initial Shared Territory Commercialization Plan and Shared Territory Commercialization Budget covering the pre-launch Commercialization activities through First Commercial Sale is attached hereto as Exhibit G (respectively, the “Initial Shared Territory Commercialization Plan” and “Initial Shared Territory Commercialization Budget”). The Parties anticipate that, following the Effective Date, the Initial Shared Territory Commercialization Plan and the Initial Shared Territory Commercialization Budget will also include, as greater clarity is obtained with respect to the Product, the plans and budget for the period commencing with [*] until the period ending [*] after [*] of [*] (the “Revised Initial Shared Territory Commercialization Plan” and the “Revised Initial Shared Territory Commercialization Budget”), which in turn will be incorporated into the overall detailed Shared Territory Commercialization Plan and the Shared Territory Commercialization Budget. Each Shared Territory Commercialization Plan and Shared Territory Commercialization Budget and subsequent revisions thereto will contain the information described above in this Section 5.2 and other information the JCC believes necessary for the successful commercial launch and subsequent Commercialization of such Product. Each Shared Territory Commercialization Plan and Shared Territory Commercialization Budget shall generally conform to the level of detail utilized by Partner ...
Sample 1

Related to Shared Territory 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.

  • 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).

  • 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 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.

  • 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:

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

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