Cholic Acid Product NDA definition

Cholic Acid Product NDA means NDA 205-570 filed by Asklepion with the FDA.
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Cholic Acid Product NDA means NDA 205-570 filed by Asklepion with the FDA. 1 . 1 9 “Cholic Acid Product Regulatory Assets ” means the Cholic Acid Product NDA, the Cholic Acid Product MSA, the Orphan Drug
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Examples of Cholic Acid Product NDA in a sentence

  • In connection with the Closing and any return of the Assets to Asklepion pursuant to Section 2.1(b)(i) and 9.3, Retrophin shall take all reasonable steps to cooperate in an orderly transfer of the Cholic Acid Product NDA (and associated IND) in accordance with all applicable FDA regulations.

  • After the Closing, Retrophin will have full ownership, control of and responsibility for the Cholic Acid Product NDA (and associated IND) and will have sole responsibility for, and control of, all subsequent FDA and other regulatory filings in respect of the Cholic Acid Product NDA (and associated IND).

  • Buyer acknowledges that Seller makes no representation, warranty or guaranty under this Agreement, including pursuant to the representations and warranties contained in Article 4, and expressly disclaims all warranties of any kind, concerning the receipt (if at all) of the Cholic Acid Product NDA or the Voucher or the indications for which the Cholic Acid Product NDA may be granted (if at all).

  • Within forty five (45) days of FDA approval of the Cholic Acid Product NDA, Retrophin will pay one-time FDA approval milestones (each, and “FDA Approval Milestone”) as follows: ( a ) Bile Acid Indications.

  • In the event that the FDA approves the Cholic Acid Product NDA for the […***…], Retrophin will, thereafter pay to Asklepion no later than forty five (45) days following the close of each calendar quarter, Royalties equal to […***…] of Net Sales of Chenodal in the United States.

Related to Cholic Acid Product NDA

  • 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.

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

  • WTO GPA country end product means an article that—

  • 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.

  • 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.

  • 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.

  • 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.

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

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

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

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • 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.

  • 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.

  • 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.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

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

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

  • 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.

  • 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.

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

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

  • Distillery manufacturing license means a license issued in accordance with

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.