Orphan Drug Indication definition

Orphan Drug Indication means any indication for a Product that meets the designation as an “Orphan Drug” under the Orphan Drug Act, 21 U.S.C. §§ 360aa-360ee, or its foreign equivalent;
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Orphan Drug Indication means a human disease or condition that is not an Initial Indication and that is designated as a rare disease or condition under the US FDA Orphan Drug Act or similar legislation or regulation in Europe.
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Orphan Drug Indication means any Indication that affects fewer than 200,000 people in the U.S.
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Examples of Orphan Drug Indication in a sentence

  • Royalties on Net Licensing Income Non-Orphan Drug Indications when Orphan Drug Indication Milestones were paid As long as there is a Valid Claim of a LUMC Patent Right ***** As long as there is a Valid Claim of an Existing Joint Patent Right, but no Valid Claim on a LUMC Patent Right ***** As long as there is a Valid Claim on a Future Joint Patent Right, but no Valid Claim of a LUMC Patent Right or Existing Joint Patent Right ***** is applicable in the default situation of article *****.

Related to Orphan Drug Indication

  • 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;

  • orphan means a child who has no surviving parent caring for him or her;

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • 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.

  • 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.

  • 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.

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

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

  • Regulatory Approval means, with respect to a product, all approvals, licenses, registrations or authorizations necessary to market and sell such product in a particular jurisdiction in the Territory (including applicable approvals of labeling, price and reimbursement for such product in such jurisdiction).

  • Phase III Clinical Trial means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a marketing application that would satisfy the requirements of 21 CFR 312.21(c).

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

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