Labeled Drug definition

Labeled Drug means a pharmaceutical product containing the Isotope-labeled B1 Antibody in either dosimetric or therapeutic final dosage form meeting Specifications, for use in Clinical Trials or for commercial sale, which has been, or is being, manufactured in accordance with the Process, compounded, formulated, finished, filled, labeled, packaged and/or delivered by Nordion pursuant to this Agreement.
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Labeled Drug means a Drug approved by applicable regulatory authorities with labeling for the Orphan Claim.
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Examples of Labeled Drug in a sentence

  • While the B1 Antibody, Isotope and Labeled Drug are in its possession or under its control, Nordion shall be responsible for complying with all applicable statutory and regulatory requirements of the Territory regarding the manufacture, handling, storage, labeling, packaging and transportation of Labeled Drug.

  • Nordion shall not ship any Batch of Labeled Drug that fails to meet Specifications, subject to Corixa's rights under this Agreement.

  • The scheduling of the shut down shall not interfere with Nordion's ability to deliver Labeled Drug pursuant to a Firm Order issued by Corixa prior to Corixa's receipt of a notice of the exact shut down dates.

  • Under no circumstances will Nordion subcontract out to a third party all or any part of the development, manufacturing or testing of (i) Labeled Drug, or (ii) the B1 Antibody without the prior written consent of Corixa.

  • Nordion shall, to the extent it has information in it possession, provide assistance to Corixa in obtaining and maintaining all licenses, registrations, listings, authorizations and approvals of any governmental entities necessary for the use of Labeled Drug in Clinical Trials and marketing of Labeled Drug wherever such activities will occur.

  • Nordion will provide Corixa with the applicable Batch records, including without limitation, a copy of any applicable Deviation or other investigatory reports and product information sheet, in final form, and/or any other certificate required by the applicable regulatory authorities for Release of each Batch of the Labeled Drug.

  • Throughout the term of this Agreement, Nordion shall notify Corixa in advance of any material change in the Nordion Quality Policies which directly has an impact on the Labeled Drug.

  • No more frequently than monthly, Nordion will provide Corixa with an invoice for the purchase price for each Batch of Labeled Drug delivered to Corixa or Corixa's designees and maintenance cost and expense as per Section 8.1, not previously invoiced.

  • The purchase price for each Batch of Labeled Drug that is produced by Nordion in accordance with a Firm Order and that meets Specifications is provided in Exhibit 9.1. Upon expiration or early termination of the Iodine Supply Agreement, the purchase price for each Batch of Labeled Drug shall be adjusted as provided for in Exhibit 9.1. In the event that Corixa purchases more than [*] Batches in a given [*] period, the Parties will meet to discuss changing the per-Batch purchase price for the Labeled Drug.

  • Corixa shall at all times own, including while remaining a raw material or used in the manufacture of Labeled Drug at the Nordion Site, (i) the B1 Antibody, and (ii) the CD-20 Antigen Cells.

Related to Labeled Drug

  • New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

  • Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:

  • Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • FFDCA means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).

  • New Drug Application or “NDA” means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the US.

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

  • Prescription drug order means a lawful order from a practitioner for a drug or device for a specific patient, issued for a legitimate medical purpose within the prescriber’s course of legitimate practice and including orders derived from collaborative pharmacy practice.

  • Prescription drug means any drug required by federal law or regulation to be dispensed only

  • 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;

  • Drug addiction means a disease characterized by a

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Narcotic drug means any of the following, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

  • low protein modified food product means a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a Practitioner for the dietary treatment of an inherited metabolic disease, but does not include a natural food that is naturally low in protein; and

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

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

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • FDA means the United States Food and Drug Administration or any successor agency thereto.