Genzyme Territory Commercialization Plan definition

Genzyme Territory Commercialization Plan has the meaning set forth in Section 7.1.3 (Genzyme Territory Commercialization Plan).
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Genzyme Territory Commercialization Plan has the meaning set forth in Section 4.2.
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Examples of Genzyme Territory Commercialization Plan in a sentence

  • The Genzyme Territory Commercialization Plan for a Split Territory Licensed Product shall subsequently be updated and modified by Genzyme, from time to time at its discretion and no less frequently than once per Calendar Year, based upon, among other things, Genzyme’s Commercialization activities with respect to such Split Territory Licensed Product in the Genzyme Territory, a copy of which updated plan will be provided to the PSC responsible for such Split Territory Licensed Product.

  • Each Genzyme Territory Commercialization Plan shall be consistent with the requirements of the most recent Global Commercialization Strategy approved by the PSC.

  • If, and only if, Genzyme has exercised the Co-Co Option, this Section 7.1.5 shall apply to HD Licensed Products solely in the United States and Section 7.1.3 (Genzyme Territory Commercialization Plan) shall apply with respect to such HD Licensed Products in countries in the Genzyme Territory (other than the United States).

  • Each Genzyme Territory Commercialization Plan shall be consistent with the requirements of the initial Global Commercialization Strategy approved by the PJSC pursuant to Section 4.1.1 (Global Commercial Strategy) or the most recently approved by the PJSC without the use of tie-break authority pursuant to Section 5.7.3 (Tie-Breaking).

  • All such Promotional Materials will be compliant with applicable Law, consistent in all material respects with the Genzyme Territory Commercialization Plan and, if applicable, consistent in all material respects with the Global Branding Strategy for such Regional Licensed Product in the Genzyme Territory.

  • Assets Make a list of everything you own, or will have acquired by the starting date, that will be used in your business.

  • All such Promotional Materials will be (a) compliant with applicable Law, (b) consistent in all material respects with the Genzyme Territory Commercialization Plan, and (c) if applicable, consistent in all material respects with the Global Branding Strategy.

  • Notwithstanding the foregoing, in the event of any disagreement between the Parties regarding the Genzyme Territory Commercialization Plan pursuant to Section 5.5, the Genzyme representatives on the JSC shall have final decision-making authority over the preparation and updating of the Genzyme Territory Commercialization Plan; provided that, such decisions do not materially adversely affect the Commercialization of a Licensed Product in the Alnylam Territory.

  • The Genzyme Territory Commercialization Plan for a Regional Licensed Product shall subsequently be updated and modified by Genzyme, from time to time at its discretion and no less frequently than once per Calendar Year, based upon, among other things, Genzyme’s Commercialization activities with respect to such Regional Licensed Product in the Genzyme Territory, a copy of which updated plan Genzyme will provide to the PJSC responsible for such Regional Licensed Product.

  • The Genzyme Territory Commercialization Plan shall subsequently be updated and modified by Genzyme, from time to time at its discretion and no less frequently than [**], based upon, among other things, Genzyme’s Commercialization activities with respect to Licensed Products in the Genzyme Territory, a copy of which updated plan Genzyme will provide to the JSC.

Related to Genzyme Territory 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.

  • 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.

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

  • 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.

  • Licensed Territory means worldwide.

  • 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)).

  • Licensed Compounds means any EZH2 Compound(s) that is:

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

  • 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.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

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

  • 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 Activities means any activity, including the discharge of dredged or fill material, which results directly in a more than de minimus change in the hydrologic regime, bottom contour, or the type, distribution or diversity of hydrophytic vegetation, or which impairs the flow, reach, or circulation of surface water within wetlands or other waters;

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

  • Development Program means the implementation of the development plan.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Licensed Compound means [***].

  • 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.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Service Territory means the geographic area within which PG&E as a Utility Distribution Company is authorized and required to provide electric transmission and distribution service.

  • 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.