HD Collaboration Program definition

HD Collaboration Program means the program of research and Development of Gene Therapy Products that deliver a transgene encoding a molecule that functions to directly or indirectly reduce the levels of mutant huntingtin protein (including VY HTT01) and are Developed for the treatment, diagnosis or prevention of HD or a Secondary Indication (a) as conducted by Voyager prior to the Effective Date or (b) conducted by the Parties pursuant to this Agreement after the Effective Date. The foregoing will not be interpreted to limit Genzyme’s right to Develop and Commercialize HD Licensed Products for any indication.
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Examples of HD Collaboration Program in a sentence

  • Concerning musk deer, Moschus spp., the Secretariat announced its intention to meet with the representative of China and the Chairman of the Animals Committee to determine how to proceed with the implementation of recommendations, and to invite representatives of Mongolia and the Russian Federation to participate.

  • The Co-Co Option applies to the HD Collaboration Program, in accordance with Section 3.1.2 (HD Licensed Product Co-Co Option Grant).

  • In accordance with Section 3.1.1 (Split Territory Program Option Grants), the Split Territory Program Option applies to the HD Collaboration Program, the PD Collaboration Program, the FA Collaboration Program and the Future Collaboration Program, which collectively comprise the Split Territory Collaboration Programs.

  • The initial Collaboration R&D Plans for each Collaboration Program other than the Future Collaboration Program are attached hereto as Schedule 4.3.1-1 for the HD Collaboration Program (the “HD Collaboration R&D Plan”), 4.3.1-2 for the PD Collaboration Program (the “PD Collaboration R&D Plan”), 4.3.1-3 for the FA Collaboration Program (the “FA Collaboration R&D Plan”), and 4.3.1-4 for the SMA Collaboration Program (the “SMA Collaboration R&D Plan”).

  • In lieu of exercising the Split Territory Program Option with respect to the HD Collaboration Program, on the Option Exercise Date for the CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • Such data, reports, records, materials or other information may include (a) governmental or regulatory correspondence, conversation logs and filings solely relating to any HD Collaboration Product, (b) non-clinical and clinical data relating to the HD Collaboration Program and (c) adverse event data related to any HD Collaboration Product, in each case, in Genzyme’s possession or Control.

Related to HD Collaboration Program

  • 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 Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • 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.

  • 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 Program means the implementation of the development plan.

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

  • Research Program Term has the meaning set forth in Section 2.2.

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

  • Collaboration Term has the meaning set forth in Section 2.1(h).

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

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • 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.

  • 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;

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Collaboration has the meaning set forth in Section 2.1.

  • 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.

  • 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.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • 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).

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.