FDA Products definition

FDA Products means any finished products sold by Borrower or any of the other Loan Parties for itself or for a third party that are subject to applicable Health Care Laws.
Sample 1Sample 2Sample 3
FDA Products means any finished products sold by any Borrower or any of the other Loan Parties for itself or for a third party that are subject to the FDA Law and Regulation.
Sample 1Sample 2Sample 3
FDA Products has the meaning given in Section 9.16(f) below.
Sample 1

Examples of FDA Products in a sentence

  • Accentia will use its best efforts to maximize the sale of Products and FDA Products, if any, in each country in which Accentia has the right to sell any such Products or FDA Products, as the case may be.

  • Since January 1, 2019, to the Knowledge of the Company, none of the FDA Products of the Company or any of its Subsidiaries has been proposed, requested, ordered, threatened or considered for a seizure, denial, detention, termination, suspension of manufacturing or marketing, import alert or safety alert by the FDA or any other Governmental Authority.

  • All FDA Products in current commercial distribution as an FDA regulated HCT/P meet the definition of an HCT/P in 21 C.F.R. § 1271.3 and, on that basis, do not currently require premarket clearance or approval under the FDCA or PHSA.

  • Accentia will provide the marketing services for the FDA Products as set forth in Schedule 1 attached hereto (the “Marketing Services”).

  • Where the FDA Products are exempt from compliance with the Quality System Regulation, the Company and each Subsidiary has designed or is designing or manufacturing the FDA Products under a reasonable state of control as otherwise required by FDA Laws.

  • To the Knowledge of the Company, no debarment or exclusionary claim, action, proceeding or investigation in respect of the business or FDA Products of the Company or any of its Subsidiaries is pending or threatened against the Company or any of its Subsidiaries or any of its or their respective officers, directors, employees or agents.

  • No modifications, including the marketing of such FDA Products for additional intended uses, have been made to the FDA Products that require the clearance of a Premarket Notification or approval of a Premarket Approval Application by the FDA and for which such Premarket Notification or Premarket Approval Application has not been submitted to the FDA.

  • ACCENTIA will deliver to MAYO on or before the following dates: 1 February, 1 May, 1 August, and 1 November, a written report stating Sales on which Earned Royalties are based for the preceding License Quarter, or stating the status of development of Products and FDA Products and of preparations to market Products and FDA Products if marketing has not yet begun.

  • Where the FDA Products are exempt from compliance with the Quality System Regulation, the Company Group has designed or is designing or manufacturing the FDA Products under a reasonable state of control as otherwise required by FDA Laws and Regulations.

  • The Company’s Springfield facility and its records relating to the FDA Products were inspected in 1999, 2003, and 2004 by the FDA, and a Form FDA 483 Notice of Observations was not issued at the conclusion of any of these inspections.


More Definitions of FDA Products

FDA Products has the meaning set forth in Section 3.15(d).
Sample 1
FDA Products means any finished products sold by Borrower or any of the other Loan Parties for itself or for a third party that are subject to applicable Health Care Laws. Federal Funds Effective Rate means, for any day, the greater of (a) the rate calculated by the Federal Reserve Bank of New York based on such day’s Federal funds transactions by depositary institutions (as determined in such manner as the Federal Reserve Bank of New York shall set forth on its public website from time to time) and published on the next succeeding day on which commercial banks are open for commercial banking business in New York, New York, by the Federal Reserve Bank of New York as the Federal funds effective rate and (b) 1.00%.
Sample 1

Related to FDA Products

  • Hemp products means all products made from industrial hemp,

  • 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.

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Cannabis products 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.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • 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.

  • SAP Products means Software, Documentation, SAP Materials, Services, Subscription Services, Cloud Services and Maintenance Services. “SAP SDK” means SAP software development kit that includes tools such as APIs, source code, redistributable files and instructions. “Services” means SAP’s then-current services offered under and described in detail in the applicable SAP PartnerEdge Model.

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

  • the Products means all products and associated documentation to be supplied under this Contract;

  • 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;

  • Products means information resources technologies that are, or are related to, EIR.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

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

  • 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.”

  • 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.

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

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

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

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

  • 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.

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

  • Marijuana-infused products means products that contain marijuana or marijuana extracts and are intended for human use. The term "marijuana-infused products" does not include useable marijuana.

  • Steel Products means products rolled, formed, shaped, drawn, extruded, forged, cast, fabricated or otherwise similarly processed, or processed by a combination of two or more or such operations, from steel made by the open heath, basic oxygen, electric furnace, Bessemer or other steel making process.

  • 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.