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

  • This work was performed when he was with the Department of ECE, The University of Texas at Austin, Austin, TX 78712, USA.A. G.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Toll Manufacturing Agreement (Ezetimibe Monotherapy Product) shall be amended and restated in the form attached hereto as Exhibit 30, to expand the definition of "Territory" to include ECLAFE.

  • 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.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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 any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • 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 in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • 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 any EZH2 Compound(s) that is:

  • 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.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • 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.

  • 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.

  • 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 or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.

  • Therapeutic school means a residential group living facility:

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).