Monotherapy Product definition

Monotherapy Product means a Product incorporating the Compound as the sole active ingredient.
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Examples of Monotherapy Product in a sentence

  • Under such agreement(s) the S-P QP shall undertake the general responsibilities of a Qualified Person for the Ezetimibe Monotherapy Product for the European Economic Area and its obligations shall include batch release and disposition decisions, import testing, stability testing and all other technical/quality investigations, for the European Economic Area as well as the EMEA.

  • An Affiliate of M acting as toll packager pursuant to paragraph (f) below shall enter into one or more agreements with the Affiliate of S-P under which the M Affiliate shall furnish to the S-P QP such data and services regarding its operations as toll packager for the Ezetimibe Monotherapy Product as the S-P QP may reasonably require to discharge its responsibilities as a Qualified Person.

  • It is understood that during the period of time from the Effective Date and through the Restatement Effective Date, the Parties have conducted Development activities pursuant to a development plan and corresponding budget under the Original Agreement for a Monotherapy Product and a Co-Administration Product in the Field in the Territory ****** - Material has been omitted and filed separately with the Commission.

  • Those particular cells that express the antigen of interest will move through the blood under the influence of the system's magnetic gradient and present themselves to the optical detection system.

  • At least [***] prior to the anticipated First Licensed Sale of a Monotherapy Product under this PD-1 Agreement in the United States, the JWG shall discuss and agree upon the form and content for such Commercialization Report.

  • In addition, Amicus shall use its Commercially Reasonable Efforts to obtain Regulatory Approval for at least ****** Monotherapy Product and ****** Co-Formulation Product in the Field in the Amicus Territory.

  • Jounce shall be responsible for Regulatory Interactions for any Monotherapy Product in the United States and any of its Non-Collaboration Combination Products anywhere in the Territory.

  • Celgene shall be responsible for Regulatory Interactions for any Monotherapy Product in the ROW Territory and any of its Non-Collaboration Combination Products anywhere in the Territory.

  • Intellectual property created jointly by ALMIRALL and FOREST will be treated in a manner consistent with the foregoing (i.e., it shall be owned by ALMIRALL subject to FOREST’s license hereunder and, in the event not exclusively related to LAS 34273 Monotherapy Product or Combination Product, FOREST may retain its joint ownership interest, subject to the perpetual, royalty-free license to ALMIRALL as described above).

  • Once you have determined that substance abuse is an issue in the case, meet it head on.

Related to Monotherapy Product

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

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

  • 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.

  • 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.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • 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.

  • Licensed Compound 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.

  • 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.

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

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

  • 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;

  • 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.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • 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”).

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

  • 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.

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

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

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

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

  • 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."

  • 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.

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

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.