PD Collaboration Program definition

PD Collaboration Program means the program of research and Development of Gene Therapy Products that deliver a transgene encoding a molecule that directly or indirectly increases the level of aromatic L-amino acid decarboxylase protein (including VY-AADC01) and are Developed for the treatment, diagnosis or prevention of PD or a Secondary Indication (a) 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 PD Licensed Products for any indication.

Examples of PD Collaboration Program in a sentence

  • Unless the DAC elects to utilize the Genzyme PD Technology in accordance with Section 4.5 (Use of Genzyme PD Technology) or unless otherwise agreed by Genzyme, the initial Split Territory Global Development Plan for the PD Agreement Product will contain all of the Development activities set forth in the Collaboration R&D Plan for the PD Collaboration Program attached hereto as Schedule 4.3.1-2 that are not yet completed at the time of the delivery of the Option Data Package.

  • 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 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.

  • As of the Effective Date, the four Collaboration Programs shall be (a) the PD Collaboration Program, (b) the HD Collaboration Program, (c) the FA Collaboration Program, and (d) the SMA Collaboration Program.

Related to PD Collaboration Program

  • Research Program has the meaning set forth in Section 2.1.

  • Development Program means the implementation of the development plan.

  • 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 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 Term has the meaning set forth in Section 2.2.

  • 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 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.

  • 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 clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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;

  • 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.

  • 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.

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

  • 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 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.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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 Plan has the meaning set forth in Section 3.2.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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.

  • 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.

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

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