Gene Therapy Products definition

Gene Therapy Products means all products that primarily utilize Gene Therapy.
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Gene Therapy Products means two or more of the foregoing;
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Gene Therapy Products. Novartis shall pay Osiris, for each individual Gene Therapy Product, the following royalties as a percentage of all Net Sales of that Product in the Territory made by Novartis, its Affiliates, licensees and sublicensees: [*CONFIDENTIALITY REQUESTED*] For the avoidance of doubt, the above table means, for example, that the royalty payable upon world-wide Net Sales of a Gene Therapy Product of [*CONFIDENTIALITY REQUESTED*]
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Examples of Gene Therapy Products in a sentence

  • During training, volunteers examine their own values and prejudices with respect to raising children and receive training on ethnic and cultural awareness.

  • Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, January 2011.

  • Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, November 2013.

  • The new drug application data were subjected to a document-based compliance inspection and a data integrity assessment in accordance with the provisions of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics.

  • Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry, June 2015.

  • In addition to GMP requirements, the ‘Good Tissue Practice’ guidelines define the requirements that govern the methods used in, and the facilities and controls used for, the manufacture of Human Cell Therapy and Gene Therapy Products in a way that prevents the introduction, transmission, or spread of communicable diseases by these products.

  • For additional information on potency assays, please see FDA’s Guidance for Industry: “Potency Tests for Cellular and Gene Therapy Products (Ref.

  • Testing of Retroviral Vector- Based Human Gene Therapy Products for Replication Competent Retrovirus during Product Manufacture and Patient Follow-up; Guidance for Industry” is available at this website: https://www.fda.gov/media/113790/download.

  • For additional guidance on trial design for GT products we refer you to FDA’s guidance document “Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry” dated August 2015 (Ref.

  • Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products, August 2015.


More Definitions of Gene Therapy Products

Gene Therapy Products. Novartis shall have the right to manufacture Gene Therapy Products for sale in any country of the Territory, including North America. If Novartis does not intend by itself or by an Affiliate to manufacture Gene Therapy Products for sale in North America, Novartis shall obtain its requirements of MSCs for Gene Therapy Products for sale in North America from Osiris, upon the same conditions as set out above for MSC Products, as specified in a corresponding Supply Agreement. Any vectors for the transformation of such MSCs shall be manufactured by Novartis or its Affiliate.
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Related to Gene Therapy Products

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

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

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed Field means all fields of use.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Hemp products means all products made from industrial hemp,

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Products means information resources technologies that are, or are related to, EIR.

  • 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.