Licensed Combination Product definition

Licensed Combination Product means any Licensed Product comprising a Licensed Candidate and one or more other active ingredient(s) that is not itself a Licensed Candidate (such other active ingredients, “Other Actives”). For clarification, the term “Other Active,” when referring to an ingredient included in such Licensed Product refers to ingredients that are incorporated or included in the Licensed Product for [***] (whether in the same or different formulations, or dosed separately or together) for the purpose of [***]; the term excludes such ingredients that are present in such a Licensed Product [***].
Sample 1Sample 2Sample 3
Licensed Combination Product has the meaning given to such term in the Sublicence;
Sample 1Sample 2
Licensed Combination Product means any pharmaceutical product for human use in the Territory within the Novo Nordisk Field which contains a Novo Nordisk Proprietary Molecule fused to a Selected Ligand Trap into a single molecule or a co-formulation of a Novo Nordisk Proprietary Molecule and a Selected Ligand Trap.
Sample 1Sample 2

Examples of Licensed Combination Product in a sentence

  • Only one payment of royalties shall be due with respect to the same unit of a Licensed Product or Licensed Combination Product, and no multiple royalties shall be payable because any Licensed Product or Licensed Combination Product, or its manufacture, sale or use, is covered by more than one Valid Claim or is subject to both Supernus Know-How and a Valid Patent Claim.

  • Each Party shall keep and maintain all records required by law or regulation with respect to development of a Licensed Product or Licensed Combination Product and shall make copies of such records available to the other Party upon request.

  • Subject to the terms and conditions contained in this Agreement, and in consideration of the rights granted by Supernus hereunder, United Therapeutics shall pay Supernus, or an Affiliate of Supernus designated in writing, the following Milestone Payments as pertaining to the development of each Licensed Combination Product, contingent upon the occurrence of the corresponding specified contingent Milestone Event detailed below.

  • Net Sales shall be determined in accordance with GAAP in the currency in which each Licensed Product or Licensed Combination Product was sold and shall be converted into United States dollars using the average buying rate as published in the Wall Street Journal for the [**] for which such payment is being determined.

  • For the sake of clarity, the parties acknowledge and agree that, after the Exclusivity Term, Sanofi-Aventis shall not grant an out-license except to Third Parties who are parties to a collaboration agreement with Sanofi-Aventis to jointly develop or jointly market Licensed Combination Products, and shall not grant any such license or other right to any Third Party to enable or permit such Third Party to commercialize any Licensed Combination Product independent of Sanofi-Aventis.

  • One Hundred and Fifty Thousand ($150,000) Dollars within sixty (60) days of a Product License Approval (PLA) from the FDA on a Licensed Product, Licensed Combination Product or Licensed Process.

  • Company shall maintain in effect insurance in the combined amount of one million dollars ($1,000,000) per occurrence for bodily injury and property damages, including reasonable attorney fees, arising out of any alleged defects in Licensed Product, Licensed Combination Product, Licensed Processes and Licensed Services or in the use thereof.

  • In this experiment, the new dynamic Garbage Collection Model with the improved calculation of the free ratio is used.

  • Seventy-five Thousand ($75,000) Dollars within sixty (60) days of FDA approval of a Phase I Investigational New Drug Application (IND) on a Licensed Product, Licensed Combination Product or Licensed Processes.

  • Company agrees not to use the name of University or any of its employees, in any advertisement or sales promotion relating to any Licensed Product, Licensed Combination Product, Licensed Processes and Licensed Services without prior written approval by University.


More Definitions of Licensed Combination Product

Licensed Combination Product means an oral pharmaceutical composition: (a) containing the Compound as an active ingredient in combination with (an)other active ingredient(s) (subject to the limitation set out in Clause 2.8); and (b) where the combination of active ingredients, quantitative composition and pharmaceutical form of the composition i. corresponds to that of a pharmaceutical composition which has been approved for use in Paediatric Patients by the FDA, and/or ii. has been recommended by the World Health Organisation or the United States Department of Health and Human Services for use in Paediatric Patients, but for the avoidance of doubt shall not be limited to a pharmaceutical composition approved or recommended solely for use in Paediatric Patients; and (c) prepared and ready for administration to Child Patients solely for antiretroviral therapy for HIV/AIDS.
Sample 1
Licensed Combination Product means a Licensed Product that includes one or more genes for which Licensee or a Product Sublicensee must pay royalties, upon Disposition, to one or more Third Party Licensors.
Sample 1
Licensed Combination Product means
Sample 1
Licensed Combination Product means a Licensed Product that contains Ramipril as one of its active ingredients and contains at least one additional active ingredient.
Sample 1

Related to Licensed Combination Product

  • 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.

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad 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 Compound means [***].

  • 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.

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

  • 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”).

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

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

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

  • 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.

  • Competing Product 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.

  • 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.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • 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)).

  • 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.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.

  • 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.

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

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

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

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