Product Commercialization Plan definition

Product Commercialization Plan means, with respect to each Product, the written plan for the Commercialization of such Product in the Territory (including, without limitation, expected manufacturing scale-up, manufacture, formulation and filling requirements for such Product and a detailed strategy, budget and proposed timelines), as such plan may be amended or updated.
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Product Commercialization Plan shall have the meaning provided under Section 3.3
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Product Commercialization Plan has the meaning set forth in Section 3.3(B) of this First Amendment.
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Examples of Product Commercialization Plan in a sentence

  • The Licensor Product Commercialization Plan shall be updated and reviewed at least annually.

  • Each Party shall perform its obligations under each Development Plan and Product Commercialization Plan in good scientific manner and in compliance in all material respects with all Laws.

  • Company and Licensor shall cooperate in the performance of the Development Program and, subject to the terms of this Agreement and any confidentiality obligations to Third Parties, shall exchange such data, information and materials as is reasonably necessary for the other Party to perform its obligations under any Development Plan and Product Commercialization Plan.

  • Novartis will use Commercially Reasonable Efforts to (a) Commercialize each Global Licensed Product for which Novartis has obtained Regulatory Approval in the Novartis Territory, and (b) perform all Commercialization activities for each Global Licensed Product in accordance with the Global Licensed Product Commercialization Plan.

  • Failure to provide such Product Commercialization Plan prior to filing a MAA shall not be a breach of this Agreement, but in any event within [...***...] of filing a MAA in the Territory with respect to each Product, Company shall provide such Product Commercialization Plan to the JAC.

  • If Company has exercised the option to continue the Agreement under Section 4.1(b) above, within [...***...] of filing a MAA outside the Territory with respect to each Product, Licensor shall prepare and provide to the JAC for its review a Product Commercialization Plan for each such Product.

  • Following submission of the first Product Commercialization Plan for a Product or such later date as the Parties may agree in writing, AstraZeneca shall provide Targacept with [********] written updates to each Product Commercialization Plan for such Product, which shall [********]; provided, however, that in no event shall AstraZeneca be required to include [********] in such reports [********].

  • If Company has exercised the option to continue the Agreement under Section 4.1(b) above, then Company will make a reasonable effort to prepare and provide to the JAC for its review a Product Commercialization Plan for each Product [...***...] prior to the date Company anticipates filing a MAA in the Territory.

  • The JSC shall appoint a Joint Commercialization Committee (“JCC”) whose purpose is to propose the US Profit Share Product Commercialization Plan to the JSC.

  • The Product Commercialization Plan, attached as Appendix F to the Agreement and incorporated by reference thereto, will include commercially reasonable timelines and levels of diligence necessary for Kraft to maintain the co-exclusive license, as provided for under Section 10.1(A) of this First Amendment herein.


More Definitions of Product Commercialization Plan

Product Commercialization Plan has the meaning set forth in Section 5.1 (5.1 Manufacture and Supply of Products).
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Product Commercialization Plan means, with respect to each Product, the written plan for the Commercialization of such Product in the Territory (including, without limitation, a reasonably detailed summary of the strategy and proposed timelines), as such plan may be amended or updated. Each Product Commercialization Plan shall include for each of the U.S. Territory and the ROW Territory, (a) the Commercialization objectives, [***]; (b) a timeline for such activities, including projected milestones and estimated launch date(s); and (c) a sales forecast (including at least two (2) years of estimated sales). Each Product Commercialization Plan, and update to each Product Commercialization Plan, shall be prepared by MERCK and provided to the JCC.
Sample 1
Product Commercialization Plan means, with respect to each Licensed Product (including without limitation any Co-Commercialized Licensed Product), the written plan for the Commercialization of such Licensed Product in the Territory (including, without limitation, expected pre-launch and launch activities (other than for Development), Manufacturing scale-up, Manufacture, formulation and filling requirements for such Licensed Product and a detailed strategy, budget and proposed timelines), as such plan may be amended or updated. Each Product Commercialization Plan, and each amendment, modification or update to each Product Commercialization Plan, shall be prepared by, or at the direction of, DS, and approved by the JSC at such time as the JSC may from time to time direct and in any event, on or prior to the initiation of Commercialization activities with respect to the Licensed Product.
Sample 1
Product Commercialization Plan means, with respect to each Product, the written plan for the Commercialization of such Product in the U.S. Territory (including, without limitation, expected Manufacturing requirements, for such Product; and a detailed strategy, budget and proposed timelines), as such plan may be amended or updated. Each Product Commercialization Plan shall include, without limitation, (a) demographics and market dynamics, market strategies, a marketing plan (including advertising, Detailing forecasts, pricing strategies pertaining to discounts, samples and sales forecasts) for the U.S. Territory, (b) the specific Commercialization objectives, projected milestones, resource allocation requirements and activities to be performed over such period (including, without limitation, all anticipated Clinical Trials); (c) the Party responsible for such activities; (d) a timeline for such activities, including the estimated launch date(s) in the U.S. Territory; (e) a sales and expense forecast (including at least five (5) years of estimated sales and expenses) for the U.S. Territory, (f) Manufacturing plans and the expected product profile, (g) a “Commercialization Budget” including a budget of the expenses expected to be incurred in performing all activities therein contained, as well as any Third Parties proposed to be utilized and, to the extent applicable, any proposed Third Party arrangements, and (h) the expected Regulatory Filings to be required and prepared, and the expected timetable for making such Regulatory Filings. Each Product Commercialization Plan, and each amendment, modification or update to each Product Commercialization Plan, shall be prepared by, or at the direction of, the JCC, and approved by the JSC at such time as JSC may from time to time direct and in any event, on or prior to the initiation of Commercialization activities with respect to the Product and shall be attached to the minutes of the meeting of the JSC at which such Product Commercialization Plan or amendment, modification or update is approved by the JSC.
Sample 1

Related to Product Commercialization Plan

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Development Plan has the meaning set forth in Section 3.2.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Development Program means the implementation of the development plan.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Marketing Plan has the meaning set forth in Section 4.3(a).

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.