Voyager CNS Orphan Disease Program definition

Voyager CNS Orphan Disease Program means a gene therapy program of Voyager, other than the PD Collaboration Program, the HD Collaboration Program or the FA Collaboration Program, that is in Development by Voyager for a CNS Orphan Disease and that (a) is not the subject of an IND filed with FDA that has achieved Acceptance, (b) is not subject to a contract with a Third Party pursuant to which Voyager has granted a Third Party the exclusive right or exclusive option to Develop and Commercialize products under such program in Japan and all of the MMCs in the European Union and (c) is not Voyager’s amyotrophic lateral sclerosis (“ALS”) gene therapy program using a microRNA approach modulating superoxide dismutase gene expression (including VY SOD101).
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Voyager CNS Orphan Disease Program means a gene therapy program of Voyager, other than the PD Collaboration Program, the HD Collaboration Program or the FA Collaboration Program, that is in Development by Voyager for a CNS Orphan Disease and that (a) is not the subject of an IND filed with FDA that has achieved Acceptance, (b) is not subject to a contract with a Third Party pursuant to which Voyager has granted a Third Party the exclusive right or exclusive option to Develop and Commercialize products under such program in Japan and all of the MMCs in the European Union and
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Examples of Voyager CNS Orphan Disease Program in a sentence

  • If Voyager desires to enter into a Third Party CNS Agreement with respect to a given Voyager CNS Orphan Disease Program during the Designation Period, then Voyager shall so notify Genzyme in writing at least [***] days in advance of entering into such Third Party CNS Agreement.

  • Genzyme shall have the right, exercisable in its sole discretion in accordance with Section 2.2.4 (Designation of Future Collaboration Program) to designate any one Voyager CNS Orphan Disease Program as a Collaboration Program to which the Split Territory Program Option applies (the “Future Collaboration Program”).

  • In addition, Genzyme shall have the right, exercisable in accordance with Section 2.2.4 (Designation of Future Collaboration Program), to designate any one Voyager CNS Orphan Disease Program as a Collaboration Program under this Agreement (the Future Collaboration Program).

  • All proceeds of insurance with respect to loss or damage to the Premises shall be payable to the City.

  • During the Notice Period, Voyager shall provide Genzyme with such information regarding such Voyager CNS Orphan Disease Program as Genzyme may reasonably request, which information shall be Voyager Confidential Information for the purposes of Section 10 (Confidentiality and Publication).

  • If Genzyme does not deliver a Future Collaboration Designation Notice with respect to such Voyager CNS Orphan Disease Program during the Notice Period then, upon expiration of the Notice Period, Voyager shall have the right to enter into a Third Party CNS Agreement with respect to such Voyager CNS Orphan Disease Program for a period of [***].

  • Genzyme shall have [***] days from receipt of such written notice (the “Notice Period”) to provide Voyager with a Future Collaboration Designation Notice with respect to such Voyager CNS Orphan Disease Program.

  • Voyager shall not enter into a Third Party CNS Agreement with respect to such Voyager CNS Orphan Disease Program during the Notice Period.

  • At any time during the Designation Period, if Genzyme is considering designating a Voyager CNS Orphan Disease Program as the Future Collaboration Program, Genzyme may request that Voyager prepare a proposed Collaboration R&D Plan for such potential CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • If Genzyme then designates such Voyager CNS Orphan Disease Program as the Future Collaboration Program, then such revised draft Collaboration R&D Plan shall become the Collaboration R&D Plan for the Future Collaboration Program and such plan (the “Future Collaboration R&D Plan”) shall be attached as Schedule 4.3.1-5 hereto.

Related to Voyager CNS Orphan Disease Program

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Collaborative pharmacy practice agreement means a written and signed

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Wild animal means any mammal, bird, fish, or other creature of a wild nature endowed with sensation and the power of voluntary motion.

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

  • 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.

  • 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.

  • AML Program has the meaning ascribed thereto in Schedule 2.1(F)(8) hereof.

  • 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.

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • 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.

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

  • 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)).

  • 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.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • 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.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto.

  • 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 II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • 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 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.