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, with respect to a Licensed Product, a grant of a period of marketing exclusivity by a Regulatory Authority for such Licensed Product in connection with an Orphan Drug Designation for such Licensed Product.

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.

Examples of Orphan Drug Exclusivity in a sentence

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.
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.
The Director of Human Resources shall have five (5) working days from the date of receipt to render a decision.
Royalties for Genentech Products achieving Orphan Drug Exclusivity (“Orphan Genentech Products”).
For the sake of clarity, if cumulative sales in the FDA Granted Orphan Exclusivity Territory reached $50,000,000, but $1,000 of the $50,000,000 in sales occurred after the Orphan Drug Exclusivity Term ended, then $0 of the $875,000 first payment would be due.

More Definitions of Orphan Drug Exclusivity

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.

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.

Orphan Drug Exclusivity means the seven (7)-year period during which, as provided for by FD&C Act Section 527, the FDA is prohibited from approving another product that is the “same drug,” as that term is defined in 21 CFR 316.3(b)(14), as a previously approved drug for a rare disease or condition.

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.

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.

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.

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.