Non-Core Commercialization Plan Sample Clauses

Non-Core Commercialization Plan. For each Licensed Product, Kite shall develop for the CWG’s and JSC’s review (for each Licensed Product) and approval (for each Co-Promote Product) a Non-Core Commercialization Plan for such Licensed Product (which plan shall be consistent with the Global Strategic Plan for such Licensed Product if it is a Co-Promote Product) that sets forth the Commercialization activities to be undertaken with respect to such Licensed Product in the Field in the ExUS Territory [***], and Non-Co-Promote Products in the Field in the US. The Commercialization of each Licensed Product in the Field in the ExUS Territory and Non-Co-Promote Products in the Field in the U.S. shall be governed by the Non-Core Commercialization Plan for such Licensed Product. The Non-Core Commercialization Plan for a Licensed Product shall be a [***]-year rolling plan, updated annually as provided in Section 5.4.6(c), and shall include a rolling [***]-year budget setting forth the budgeted amounts for costs with respect to activities set forth in such Non-Core Commercialization Plan during the then-current Calendar Year and the successive [***] Calendar Years thereafter. Kite will have responsibility for determining strategy and overall guidelines regarding the Marketing, market access, Medical Affairs, and sales for Licensed Products in the Field in the ExUS Territory and Non-Co-Promote Products in the Field in the US, and development of Promotional Materials and packaging for Licensed Products in the Field in the ExUS Territory and Non-Co-Promote Products in the Field in the US (in a manner consistent with the Global Strategic Plan for Licensed Products that a Co-Promote Product). The initial Non-Core Commercialization Plan for each Licensed Product shall be submitted to the CWG and JSC for review and discussion no later than [***] months prior to the anticipated First Commercial Sale of such a Licensed Product in the ExUS Territory or such a Non-Co-Promote Product in the Territory. The Non-Core Commercialization Plan for each Licensed Product shall include [***]. The terms of and activities set forth in the Non-Core Commercialization Plan for each Licensed Product shall at all times be designed to be in compliance with all applicable Laws and to be conducted in accordance with professional and ethical standards customary in the pharmaceutical and/or cell therapy industry, taking into account where applicable Kite’s health care compliance policies and applicable SOPs. The Non-Core Commercializat...
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Non-Core Commercialization Plan. Kite shall develop and submit to the CWG for review, an updated Non-Core Commercialization Plan for each Licensed Product that includes a [***]-year rolling plan for Commercializing such Licensed Product in the ExUS Territory and such a Non-Co-Promote Product in the U.S. for each Calendar Year (and the [***] succeeding Calendar Years). Kite shall submit each such Non-Core Commercialization Plan to the CWG for review and JSC for approval no later than September 1 of the prior Calendar Year. The CWG shall review Kite’s (and its Affiliates’) performance under such Non-Core Commercialization Plan on a quarterly basis, and Kite shall develop detailed and specific updates and substantive amendments to such Non-Core Commercialization Plan that reflect such performance and submit such updates and amendments to the CWG for review on an annual basis.

Related to Non-Core Commercialization Plan

  • 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.

  • 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).

  • 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 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.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • 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.

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

  • 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:

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

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