Bulk Licensed Compound definition

Bulk Licensed Compound means the bulk form of the Licensed Compound meeting the Specifications and used to manufacture Licensed Products under this Agreement.
Bulk Licensed Compound means the bulk form of the Licensed Compound used to manufacture Licensed Products under this Agreement.

Examples of Bulk Licensed Compound in a sentence

  • Upon receipt of such sample and upon receipt of a shipment of Bulk Licensed Compound, GENE may determine whether the sample and such shipment, respectively, meet the Specifications.

  • IntraBiotics will provide BioSearch with rolling forecasts of its expected requirements of Bulk Licensed Compound over the [*] following the Effective Date on a [*] basis.

  • Any material changes to the specifications for Bulk Licensed Compound may not be made without prior written consent of both Parties.

  • To help protect against interruptions in supply of Bulk Licensed Compounds pursuant to this Article 7, BioSearch shall retain under appropriate conditions a [*] supply of Bulk Licensed Compound at all times after the parties commence production of Licensed Products for commercial launch.

  • GENE shall notify Biosearch of its receipt thereof and pay such invoices within ninety (90) days after receipt of such Bulk Licensed Compound.

  • To help protect against interruptions in supply of Bulk Licensed Compounds pursuant to this Article 7, Biosearch shall retain under appropriate conditions a supply of Bulk Licensed Compound at all times after the parties commence production of Licensed Products for commercial launch in an amount determined pursuant to this Section.

  • The reports that BioSearch shall provide to IntraBiotics pursuant to Section 2.4 shall include a summary of BioSearch's efforts to scale up the manufacturing process for Bulk Licensed Compound pursuant to Section 2.3. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.

  • Either Party shall give prior notice to the other of any changes in the specifications for Bulk Licensed Compound that are recommended or required by the regulatory authorities within the Territory.

  • IntraBiotics may elect to perform all of the manufacture of its forecasted requirements of Bulk Licensed Compound either if BioSearch is unable or unwilling to meet its supply obligations as outlined in this Article 7, if BioSearch ceases development and scale-up of manufacturing of the Bulk Licensed Compound, or as set forth in Section 8.2(c).

  • Prior to shipment of Bulk Licensed Compound, Biosearch will ship representative samples of each batch to be shipped to GENE.

Related to Bulk Licensed Compound

  • Licensed Compound means [***].

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • 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.

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

  • 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.

  • 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.

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

  • 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)).

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

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

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

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

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

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

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

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

  • 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.

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

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

  • 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.

  • 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.

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

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

  • 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.

  • Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—

  • 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;