Lead Licensed Product definition

Lead Licensed Product means a Licensed Product containing the Lead Licensed Compound as an active ingredient.
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Lead Licensed Product means the Licensed Product that is [***].
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Lead Licensed Product means the product consisting of Protein Targets that are Omega Controllers and associated Human Genome Target(s) identified on Appendix 1.46 hereto, where such product is derived from, incorporates, or utilizes any LNP Technology that is Controlled by Acuitas or its Affiliates as of the License Agreement Effective Date or at any time during the Term. Upon replacement of the Lead Licensed Product with a Backup Licensed Product, the Backup Licensed Product will become the Lead Licensed Product hereunder. For the avoidance of doubt, any product consisting of Protein Targets that are Omega Controllers that have at least [***] percent ([***]%) amino acid sequence identity to the Protein Targets that are Omega Controllers identified on Appendix 1.46 (or to the Protein Targets that are Omega Controllers in any Backup Licensed Product that becomes the Lead Licensed Product) will also be a Lead Licensed Product if such product is derived from, incorporates, or utilizes any LNP Technology that is Controlled by Acuitas or its Affiliates as of the License Agreement Effective Date or at any time during the Term.
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Examples of Lead Licensed Product in a sentence

  • The Initial Supply shall include, unless otherwise determined by the DCC, those quantities of Lead Licensed Product and Lead Licensed Compound and those activities described on Exhibit J.

  • Ardelyx will use subcontractors to manufacture and supply Lead Licensed Product and Lead Licensed Compound for use by the Parties under the Main Agreement, and Ardelyx shall enter into, or maintain contractual relationships with its subcontractors that are consistent with the provisions set forth herein.

  • The IBS-C Study will include a minimum of [***] with the Lead Licensed Product (subject to any extension which the DCC agrees should apply) and shall include at least one arm with [***].

  • The Initial Supply from Ardelyx to AstraZeneca, or to Ardelyx internally where Ardelyx has been assigned (either by the DCC or under the terms of the Agreement) the lead responsibility for the conduct of the Clinical Trial for which the supply is intended, shall include those GMP quantities of Lead Licensed Compound or Lead Licensed Product, and those development activities, in either case, approved by the DCC.

  • After the Effective Date, and promptly following AstraZeneca’s request to do so, Ardelyx shall transfer to AstraZeneca copies of all of the “Essential Documents” as defined in Chapter 8 of ICH-GCP that are Controlled by Ardelyx relating to the Lead Licensed Compound and Lead Licensed Product (the “Essential Documents”).

  • Right of Setoff...........................................................................84 SECTION 9.07.

  • The QAA shall further include provisions obligating Ardelyx to report to AstraZeneca any regulatory compliance issues with its suppliers as well as any critical quality non-conformances relating to the Lead Licensed Compound or Lead Licensed Product.

  • No such designation may occur prior to the First Commercial Sale in the United States of the former Lead Licensed Product and approval by the FDA of a Drug Approval Application for such new Licensed Product in the United States.

  • If AstraZeneca does not inform MAP in writing of its election to use the MAP Product Trademark in connection with the commercialization of the Lead Licensed Product on or before the [***] anniversary thereof, MAP shall retain all of its rights, title and interests in and to the MAP Product Trademark, such applications and registrations, and all Intellectual Property Rights and other rights and goodwill with respect thereto.

  • The QAA shall further include provisions obligating AstraZeneca to report to Ardelyx any regulatory compliance issues with respect to AstraZeneca and/or its suppliers with respect to the Lead Licensed Compound and the Lead Licensed Product, as well as any critical quality non-conformances relating to the Lead Licensed Compound or Lead Licensed Product.

Related to Lead Licensed Product

  • 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.

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

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

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

  • 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.

  • 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.

  • Licensed Compound means [***].

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

  • Licensed Territory means worldwide.

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

  • Licensed Field means [***].

  • 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 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”).

  • Licensed Services means all functions performed by the Licensed System.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Third Party Product means a product (whether hardware, software or services) supplied to you by a third party;

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

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

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

  • 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.

  • Hemp products means all products made from industrial hemp,

  • 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;

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • 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.

  • Licensed Field of Use means all fields.