API Compound definition

API Compound means bulk quantities of active pharmaceutical ingredient compound prior to the commencement of secondary manufacturing resulting in a Collaboration Product.
API Compound means bulk quantities of Compound prior to the ------------ commencement of secondary manufacturing resulting in a Collaboration Product.
API Compound means bulk quantities of Telavancin active pharmaceutical ingredient compound prior to the commencement of secondary manufacturing resulting in the Licensed Product. ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

Examples of API Compound in a sentence

  • Each Party may sublicense or subcontract its rights, if any, to Develop, manufacture and/or Commercialize the API Compound and the Licensed Product in whole or in part to one or more of its Affiliates, provided that the rights sublicensed or subcontracted to such Affiliate shall automatically terminate upon a change of control of such Affiliate in connection with which such Affiliate ceases to be an Affiliate of such Party.

  • Theravance shall be responsible, either directly or through Theravance’s vendors or contractors, for supplying at Clinigen’s expense API Compound for Commercialization activities in the Territory.

  • Such API Compound shall be manufactured and supplied in accordance with all applicable Laws and then current Good Manufacturing Practices.

  • Each Party may also sublicense or subcontract its rights, if any, to Develop, manufacture and/or Commercialize the API Compound and the Licensed Product, in whole or in part, to one or more Third Parties provided, however, that any such sublicense from Clinigen shall require the prior written consent of Theravance, such consent not to be unreasonably withheld.

  • Infringement Claim, (d) the manufacture, use, handling, storage, marketing, sale, offering for sale, importation, distribution or other disposition of the API Compound or the Licensed Product by Theravance, its Affiliates, agents or sublicensees, or (e) any agreement between Theravance and a Third Party pertaining to the Licensed Product, except to the extent such Losses result from the negligence or willful misconduct of Clinigen.

  • During the three (3) month period following the Effective Date, the Parties shall in good faith use Diligent Efforts to enter into a supply agreement to carry out the principles set forth in this Section 9.03 and to address manufacturing of the API Compound and the formulated Licensed Product, to comply with regulatory requirements for sale in the Territory.

  • A forecast for API Compound requirements for Commercialization of the Licensed Product in the Territory shall be prepared and periodically updated by the Joint Steering Committee and coordinated with the applicable Marketing Plan for the Licensed Product.

  • Clinigen will reimburse Theravance within forty five (45) days of receipt of itemized invoices for all of Theravance’s Fully Burdened Cost incurred after the Effective Date associated with supplying such API Compound as mutually agreed by the Parties.


More Definitions of API Compound

API Compound means bulk quantities of Telavancin active pharmaceutical ingredient compound prior to the commencement of secondary manufacturing resulting in the Licensed Product.
API Compound means the active pharmaceutical ingredient compound of TD-4208, prior to the commencement of secondary manufacturing.
API Compound means bulk quantities of THERAVANCE Compound as an active pharmaceutical ingredient prior to the commencement of secondary manufacturing resulting in the Licensed Product.
API Compound means an intermediate of Drug Product meeting the specifications set forth on Schedule 1.4 and made a part hereof.

Related to API Compound

  • 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).

  • 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.

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

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

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Compound means the taking of two or more ingredients and fabricating them into a single

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • 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.

  • 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;

  • 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.

  • 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:

  • 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.”

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • 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”).

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

  • 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.

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

  • Manufacturing Site means a location where a manufacturing

  • Recycled product means a product containing recovered material, or post-consumer recovered material, or both.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • 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.