Regeneron Product definition

Regeneron Product means any CP developed under this Agreement, including through performance of the Technology Collaboration, Regeneron Target Evaluation Plan or the Product R&D Program, that is [***] Directed to a Regeneron Target [***]
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Regeneron Product means LIBTAYO® (cemiplimab).
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Regeneron Product means have the meaning ascribed to such term in the Collaboration Agreement.
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Examples of Regeneron Product in a sentence

  • Subject to the applicable Clinical Supply Quality Agreement, either Party may, without consulting the other Party, subcontract Manufacturing with regards to either the Sponsor Product or the Regeneron Product, as applicable, to be provided for such Study.

  • The Parties (or their Affiliates) shall enter into a Clinical Supply Quality Agreement for each Study with respect to the quality assurance of the Regeneron Product supplied by Regeneron hereunder for such Study.

  • Regeneron shall use Commercially Reasonable Efforts to prepare, file, prosecute and maintain Patents and Patent Applications within Regeneron Product Inventions.

  • The foregoing license under this Section 6.4 shall automatically terminate on a Regeneron Product-by-Regeneron Product basis simultaneous with the termination of the license under Section 6.3 with respect to such Regeneron Product.

  • Sponsor may not use Confidential Information disclosed by or on behalf of Regeneron relating to the Regeneron Product other than for purposes of the performance of a Study Plan or in exercising its rights as set forth in this Agreement.

  • For each Study, the Study Plan shall include a forecast of quantities and delivery dates for the requirements of the Regeneron Product to be supplied under this Agreement for such Study (each a “Forecast”).

  • For all other Studies, the Parties will execute the Clinical Supply Quality Agreement as soon as reasonably practicable following the execution of the Study Plan for such Study, but in any event, prior to the initiation of the shipment of Regeneron Product for such Study.

  • Sponsor shall provide to Regeneron all Study information and documentation reasonably requested by Regeneron to enable Regeneron to (i) comply with any of its legal, regulatory and/or contractual obligations, or any request by any Regulatory Authority, related to the Regeneron Product or (ii) determine whether the applicable Study has been performed in accordance with this Agreement.

  • Regeneron shall provide the Regeneron Product to Sponsor in the form of unlabeled vials, and Sponsor shall be responsible for labeling, packaging and leafleting such Regeneron Product in accordance with the terms and conditions of the applicable Clinical Supply Quality Agreement and otherwise in accordance with all Applicable Law, including applicable cGMP, GCP, and health, safety and environmental protections.

  • If Regeneron notifies Sponsor that it is not able to meet such requirements, then Regeneron, at its option, may prepare and provide Sponsor with a time schedule for additional Manufacturing of the Regeneron Product to satisfy such requirements.

Related to Regeneron Product

  • 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.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • 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.

  • 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.

  • Licensed producer means an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Licensed Compound means [***].

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

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

  • Hemp products means all products made from industrial hemp,

  • Licensed Territory means worldwide.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Licensed Field means [***].

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • 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.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

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

  • 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.

  • Commercialized shall have corresponding meanings.

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

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

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