ROW Commercialization Plan definition

ROW Commercialization Plan has the meaning set forth in Section 5.2(b).
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ROW Commercialization Plan shall have the meaning set forth in Section 5.3.
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ROW Commercialization Plan has the meaning set forth in Section 7.2.1.
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Examples of ROW Commercialization Plan in a sentence

  • Without limiting the generality of the foregoing, Takeda shall devote Diligent Efforts to Commercialize the Product in the U.S. in the Field in accordance with the U.S. Commercialization Plan, and in the Level 1 Markets in accordance with the ROW Commercialization Plan.

  • The ROW Commercialization Plan shall be created by Takeda in good faith and in accordance with the overall strategy of Commercialization of the Product reviewed at the JSC.

  • On or before October 1, 2006, Serono shall prepare the initial ROW Commercialization Plan.

  • An Adverse Drug Reaction is an “untoward and unintended responses to an investigational medicinal product related to any dose administered”.All adverse events judged by either the reporting Investigator or the Sponsor as having a reasonable causal relationship to a medicinal product qualify as adverse reactions.

  • The ROW Commercialization Plan (including its budget) shall not require CancerVax to conduct any activities, allocate any resources, pay any costs or expenses or otherwise have any obligations thereunder, other than (a) to supply the Product in accordance with Section 8.2, (b) as specifically contemplated under ARTICLE 5 or (c) as may otherwise be agreed by the Parties.

  • Serono may, in its sole discretion, make revisions to the ROW Commercialization Plan, and shall, in the event that it makes any material changes to the ROW Commercialization Plan, provide the SC with a copy of any such revised ROW Commercialization Plan, and shall take into consideration any reasonable recommendations of the SC.

  • In connection with the review of the ROW Commercialization Plan, Serono will make available to the PT global marketing intelligence and market research information then in its possession pertaining to the Product, the usage of the Product and market trends.

  • The City may issue a written change order for any change in the work during the performance of this Contract.

  • The SC shall review and comment upon such ROW Commercialization Plan within ninety (90) days following its submission by Serono, and Serono shall consider any reasonable recommendations of the SC in modifying such ROW Commercialization Plan.

  • The GSC shall have no decision-making authority with respect to the ROW Commercialization Plan, provided, however, that Bayer shall consider in good faith any reasonable comments provided by Loxo.


More Definitions of ROW Commercialization Plan

ROW Commercialization Plan means the written plan, as amended or updated from time to time in accordance with Section 9.3, setting forth the activities to be undertaken with respect to the Commercialization of Licensed Products in the ROW Territory.
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ROW Commercialization Plan has the meaning set forth in Section 6.2(a) (RoW – Commercialization Plan).
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Related to ROW Commercialization Plan

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

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

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

  • 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.

  • 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;

  • Development Program means the implementation of the development plan.

  • 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;

  • 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)).

  • 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.

  • Research Plan shall have the meaning set forth in Section 2.1.

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

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • 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.

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

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

  • 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 Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Research Program has the meaning set forth in Section 3.1.

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

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • 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.