Developmental Product definition

Developmental Product means any product that is proposed to be, or is being, developed by either Party for use in the Field.
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Developmental Product means any product that is proposed to be, or is being, developed by either Party through the process outlined in Section 4.04 for use in the Field.
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Developmental Product means a pharmaceutical preparation for the Primary Applications containing
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Examples of Developmental Product in a sentence

  • The Relationship Managers shall in good faith consider the advisability of establishing cooperation between the Parties with respect to the development and commercialization of such proposed Developmental Product.

  • Either Party may propose a Developmental Product through its Relationship Manager to the other Party’s Relationship Manager.

  • Notwithstanding the foregoing, following FDA approval of the NDA for the Developmental Product and the transfer to Astra of the Transferred NDA, Astra and Salix shall cooperate to establish FDA approved labeling for the Product and to resolve relevant issues regarding the Transferred NDA, subject to Astra's right to final determination with respect to such issues.

  • It is understood that any monies [*] hereunder not paid by Astra on the date an approved NDA for the Developmental Product is granted by the FDA shall be remitted to Salix within 60 days after the date of such approval.

  • Section 2.6 of the Co-Participation Agreement is hereby amended and restated in its entirety as follows: "Upon completion of the Dossier, Salix shall file the NDA for the Developmental Product with the FDA and shall apply for and pursue obtaining approval for the marketing and sale of the Developmental Product in the U.S., which includes the responsibility to fund, perform and complete any Phase IV studies required by the FDA as a condition for such FDA approval.

Related to Developmental Product

  • 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.

  • 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;

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

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

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

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

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

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

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

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

  • Commercial Product means any such product as defined in FAR 2.101.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Commercialized shall have corresponding meanings.

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

  • 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.

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

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • 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.

  • Development Works means the external development works and internal development works on immovable property;

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • 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.