Orphan Drug Exclusivity definition

Orphan Drug Exclusivity means in a particular country with respect to a Licensed Product, protection available under any Applicable Law relating to treatments for rare or neglected diseases or conditions, or otherwise requiring special incentives, that prevents or delays (notwithstanding any exceptions or provisos, save to the extent that such exceptions or provisos may be applied in the particular case) the approval, production, marketing or sale of a competitive product by a Third Party, where such Third Party has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor of Licensee or any of its Affiliates, licensees or Sublicensees with respect to such product.
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Orphan Drug Exclusivity means granted orphan drug exclusivity by the applicable governmental agency, where an application has been made by the Licensee or an Affiliate for orphan drug designation for the applicable Product.
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Orphan Drug Exclusivity means, with respect to any Licensed Product in a country, an exclusive marketing right conferred under Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) or any comparable exclusivity grant in a foreign country which prevents a third party from marketing or obtaining regulatory approval to market a product substantially similar to such Licensed Product.
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Examples of Orphan Drug Exclusivity in a sentence

  • Such granted rights include use of valuable Know-How Rights, and the right to participate in the JSC and the conduct of the Development Plan so as to discover or develop Licensed Products that may not be, or may cease to be, covered by (a) Patent Rights, (b) Data Exclusivity, or (c) Orphan Drug Exclusivity.

  • Each Party expressly acknowledges that it is their intention that royalties and other consideration be paid in accordance with the terms of this Agreement, and during the periods set forth in this Agreement, notwithstanding that a Licensed Product may be royalty-bearing at a reduced rate pursuant to Section 4.8(b) in the absence of coverage by (i) Patent Rights, or after the expiration of such Patent Rights, or (ii) Data Exclusivity, or (iii) Orphan Drug Exclusivity.


More Definitions of Orphan Drug Exclusivity

Orphan Drug Exclusivity means marketing exclusivity granted by regulatory authorities in the respective country (including but not limited to the United States and European Union) which prevents others from marketing the Product.
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Orphan Drug Exclusivity means exclusive marketing rights granted by a country and/or government regulatory agency (such as the FDA, EMA, MHLW, or TGA) to a drug or biological product (“drug”) to treat a rare and/or neglected disease or condition upon regulatory approval of said drug for a given period of time (which varies from country to country) and which can run concurrently with a patent or not.
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Orphan Drug Exclusivity means any non-patent exclusivity or designation granted by a Regulatory Authority or other applicable health authority in conjunction with the approval of a Drug Approval Application for a product, which exclusivity or designation is based on the product being approved for a rare disease or condition that has been designated or otherwise recognized by the Regulatory Authority or other applicable health authority as an orphan disease or rare condition, and/or where such Regulatory Authority or other applicable health authority will not accept or will not finally approve a second Drug Approval Application for the same or similar drug for the same indication(s) which is covered by such exclusivity or designation. “Orphan Drug Exclusivity” includes orphan drug designation and exclusivity granted by the FDA pursuant to the Orphan Drug Act (as amended) and the corresponding designations and exclusivity based on the treatment of a rare disease or condition available in other countries, regions or markets in the world.
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Orphan Drug Exclusivity means the exclusivity that may be granted under 21 C.F.R. Part 316 for the development of products intended to diagnose or treat rare diseases or conditions or comparable exclusivity granted under the laws of any jurisdiction other than the U.S.
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Orphan Drug Exclusivity means the orphan drug regulatory exclusivity to which qualifying drug products are entitled following marketing approval thereof in a given country, which extends for a period of (i) seven (7) years in the United States, (ii) ten (10) years in the European Union or (iii) such time, if any, that is prescribed by Law in any other country of the world, as applicable.
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Orphan Drug Exclusivity means the orphan drug regulatory exclusivity to which qualifying drug products are entitled following marketing approval thereof in a given country, which extends for a period of (a) seven (7) years in the United States, (b) ten (10) years in the European Union or (c) such time, if any, that is prescribed by Law in any other country of the world, as applicable.
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Related to Orphan Drug Exclusivity

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • 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.

  • 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.

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

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

  • 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;

  • 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.

  • Covered drug means any prescription drug that:

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • 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.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Therapeutic school means a residential group living facility:

  • 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.

  • FDA means the United States Food and Drug Administration.

  • Biosimilar means a biological product that is highly similar to a specific reference biological

  • MHLW means the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.

  • 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.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

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

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).