Orphan Indication definition

Orphan Indication means a disease or condition which qualifies as a “rare disease or condition” under the Orphan Drug Act (21 U.S.C. 360aa et seq.) and regulations relating thereto (21 CFR Part 316), including amendments and successor laws and regulations thereto.

Orphan Indication means a disease or condition for which a product intended to treat such disease or condition has received orphan drug status from the FDA or European Medicines Agency (the “EMA”).

Orphan Indication means an Indication which is rare in the general population in the Territory, as defined by the controlling Competent Authority in the country of interest, as such definition may be amended from time to time.

Examples of Orphan Indication in a sentence

• Orphan Indication: the proposed indication for the purpose of orphan designation.

• However, if, prior to achieving the next Commercial Milestone Event, such Product is subsequently approved for an indication that is not an Orphan Indication then it will not be deemed to have achieved the next Commercial Milestone Event until it has Calendar Year Net Sales of at least [***].

• So, for example, if a Product is only approved for an Orphan Indication and achieves Calendar Year Net Sales of [***] (and no other Product Directed To the same Project Target has achieved Calendar Year Net Sales of [***]) then the first Commercial Milestone Event will be deemed achieved by such Product.

• If a Product is approved solely for an Orphan Indication (and no other indication) then the Net Sales thresholds in the Commercial Milestone portion of Table 8.2 will be deemed reduced by [***] percent ([***]%) for such Product for so long as the Product is solely approved for an Orphan Indication.

• An Orphan Indication is conveyed by the U.S. Food and Drug Administration for products that treat rare diseases and thus have little potential to become huge commercial successes.

More Definitions of Orphan Indication

Orphan Indication means, on a country-by-country basis, an indication for which a Product has been granted orphan drug exclusivity under Section 527 of the FD&C Act, or has been granted a corresponding exclusivity under the Applicable Laws of another Major Market.

Orphan Indication means any disease or condition that (a) affects less than 200,000 persons in the US or (b) affects more than 200,000 persons in the US and for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug.

Orphan Indication means an indication in the Field that satisfies the EMA criteria for an orphan disease.

Orphan Indication means a disease affecting fewer than 200,000 citizens in the U.S. or 5 per 10,000 citizens in Europe. An orphan-designated therapeutic targeting such an indication benefits from 7 years’ market exclusivity in the U.S and 10 years’ market exclusivity in the EU.

Orphan Indication means a disease that affects less than two hundred thousand (200,000) people in the United States as defined by the FDA or five (5) in ten thousand (10,000) people in the European Union as defined by the European Medicines Agency.

Orphan Indication means an indication for use of a drug to treat a rare disease or condition where the number of people affected by the disease or condition is less than 200,000 persons or where the indication for use otherwise meets the criteria for orphan drug designation under section 526(a) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. 316.21.

Orphan Indication means an indication to treat a disease or condition that meets the definition stated in the Orphan Drug Act of 1983, to include primary pulmonary hypertension.