DESI Product definition

DESI Product means the following Company Products: (A) esterified estrogen methyltestosterone and (B) opium tincture.
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DESI Product means Drug Efficiency Study Implementation Products, which can be marketed based on past marketing of an identical product that is not the subject of an approved drug application and thus does not require an ANDA (as defined below) to be marketed in compliance with the Federal Food, Drug and Cosmetics Act, as amended, and the regulations thereunder.
Sample 1
DESI Product means the following Company Products: (A) esterified estrogen methyltestosterone and (B) opiumtincture.
Sample 1

Examples of DESI Product in a sentence

  • For the purposes of this Agreement "DESI Product" shall mean Drug Efficiency Study Implementation Products, which can be marketed based on past marketing of an identical product that is not the subject of an approved drug application and thus does not require an ANDA (as defined below) to be marketed in compliance with the Federal Food, Drug and Cosmetics Act, as amended, and the regulations thereunder.

  • To the extent that the United States Food and Drug Administration ("FDA") has a required protocol for the studies designed to demonstrate the bioequivalency of a Product, other than a DESI Product (an "FDA Protocol"), then within sixty days of the delivery of such Product pursuant to Section 1 hereof, Caraco shall deliver, in writing, to Sun, a proposed protocol, which is believed in good faith by Caraco to be acceptable to the FDA (or, if applicable, a waiver of evidence of in vivo bioavailability).

  • To the extent that no FDA Protocol exists with respect to a Product (other than a DESI Product) delivered pursuant to Section 1 hereof, Caraco will, in consultation with the FDA and Sun, develop such a protocol within 150 days of delivery of such Product by Sun; and will promptly deliver such protocol to Sun after it has been developed.

  • The consideration for each DESI Product delivered shall be 181,333 (as such number may be adjusted from time to time pursuant to Section 5 hereof) Common Shares.

  • The consideration for each Product (other than a DESI Product) delivered shall be 544,000 (as such number may be adjusted from time to time pursuant to Section 5 hereof) shares of common stock, no par value, of Caraco ("Common Shares").

Related to DESI Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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.

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

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

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Bundled Product means a Licensed Product sold or bundled together with other products.

  • 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.

  • 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.

  • 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;

  • 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.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • 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.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

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

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

  • Nicotine product means the same as that term is defined in Section 76-10-101.

  • Hemp products means all products made from industrial hemp,

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

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

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • Competing Product means [***].

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • 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.

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

  • End product means those articles, materials, and supplies to be acquired under the contract for public use.