Sphingosomal Vincristine NDA definition

Sphingosomal Vincristine NDA shall have the meaning set forth in Section 3.1.1.

Examples of Sphingosomal Vincristine NDA in a sentence

  • For example, the milestone payment described in subparagraph (a) above will be due only once, following the FDA’s acceptance for review of the Sphingosomal Vincristine NDA.

  • For this son of mine was dead, and has come to life again; he was lost, and has been found.

  • In the event Hana sublicenses its rights to Sphingosomal Vincristine after the FDA approves the Sphingosomal Vincristine NDA or a Designated EU State approves a Regulatory Submission that is equivalent to an NDA, INEX shall be entitled to receive [***] percent ([***]%) of any Sublicensing Revenue payable to Hana by such Sublicensee.

  • In the event Hana licenses or sublicenses its rights to Sphingosomal Vincristine after the FDA approves the Sphingosomal Vincristine NDA or a Designated EU State approves a Regulatory Submission that is equivalent to an NDA, INEX shall be entitled to receive [***] percent ([***]%) of any Licensing/Sublicensing Revenue payable to Hana by such Licensee or Sublicensee.

  • For example, the milestone payment described in subparagraph (A) above will be due only once, following the FDA’s acceptance for review of the Sphingosomal Vincristine NDA.

Related to Sphingosomal Vincristine NDA

  • Cannabinoid means any of the chemical compounds that are the active constituents of marijuana.

  • Opioid antagonist means a drug that binds to opioid

  • Isomer means all enantiomers and diastereomers.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

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

  • Corrosion inhibitor means a substance capable of reducing the corrosivity of water toward metal plumbing materials, especially lead and copper, by forming a protective film on the interior surface of those materials.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • haemophilia means an inheritable disease, usually affecting only male but transmitted by women to their male children, characterised by loss or impairment of the normal clotting ability of blood so that a minor would may result in fatal bleeding;

  • Nicotine means nicotinic alkaloids;

  • Receptor means enclosed spaces, conduits, protected groundwater sources, drinking and non-drinking water wells, surface water bodies, and public water systems which when impacted by chemicals of concern may result in exposure to humans and aquatic life, explosive conditions or other adverse effects on health, safety and the environment as specified in these rules.

  • Total tetrahydrocannabinol means the same as that term is defined in § 3.2-4112.

  • Anaerobic digester means a liquid manure storage area that is constructed with the intent to capture and combust gas emissions resulting from the digestion of waste by microbes in anaerobic conditions. An anaerobic digester is a LMSA and is required to comply with all requirements applicable to LMSAs. Requirements specific to anaerobic digesters will be noted when applicable.

  • Pyrolysis means the thermal degradation of a substance in the absence of any oxidising agent, which does not form part of the substance itself, to produce char and gas and/or liquid; and

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

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

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

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

  • Cyanoacrylate adhesive means any adhesive with a cyanoacrylate content of at least 95% by weight.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Cannabinoid edible means food or potable liquid into which a cannabinoid concentrate, cannabinoid extract or dried marijuana leaves or flowers have been incorporated.

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

  • Antibody means a molecule comprising or containing one or more immunoglobulin variable domains or any fragments, derivatives, variants or modifications thereof that bind to the same antigen.

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.