Market Exclusivity means an exclusive benefit by grant or an exclusion under or from any Regulatory Authority relating to a Product, including orphan drug protection and data exclusivity.
Market Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a Licensed Product other than Patents, including rights conferred in the U.S. under the Xxxxx-Xxxxxx Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto outside the U.S., such as Directive 2001/83/EC (as amended) in the EU.
Market Exclusivity means, with respect to each Licensed Product in any country in the Territory, any period of data, market or other regulatory exclusivity (other than patent exclusivity) granted or afforded by applicable law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or prevents another party from using or otherwise relying on any data supporting an application for Drug Approval for such Licensed Product without the prior written consent of the holder of the approval from the Regulatory Authority.
Examples of Market Exclusivity in a sentence
The duration of AnHeart’s royalty obligation will be determined on a country-by-country basis until the later of: (i) the loss of all Market Exclusivity, (ii) the expiration of all of Valid Claims Covering Licensed Compound or Product of the Daiichi Sankyo Patents in such country, or (iii) [**Redacted**] years from the launch of the first Product that is sold by AnHeart, its Affiliate, or its Sublicensee in that country.
More Definitions of Market Exclusivity
Market Exclusivity means exclusive right to sell a Product in a country or region as the result of applicable laws and/or regulations, including data exclusivity, pediatric exclusivity.
Market Exclusivity means, on a country-by-country and Product-by-Product basis, the period of time during the Royalty Term commencing on the date as of which [*].
Market Exclusivity means, with respect to the Territory, that at least one of the following conditions exists: (i) one or more Vion Licensed Patents is being prosecuted; (ii) one or more Vion Licensed Patents has been issued and a Patent Lapse has not occurred with respect to all such issued Vion Licensed Patents; (iii) "orphan drug" status or a similar designation has been granted within the Territory with respect to one or more Products and has not expired; or (iv) trademark, trade name, trade secret or other similar protection exists with respect to one or more Products within the Territory.
Market Exclusivity means, with respect to a Licensed Product, the exclusivity granted by FDA, pursuant to Section 351(k)(7) of the Public Health Services Act, entitled “Exclusivity for Reference Product,” and any non-United States law equivalents.
Market Exclusivity means, with respect to a Product, any of the following: (i) sale of the Product in the country in question would infringe a claim of an issued patent owned or possessed (by license or otherwise) in whole or in part by a Collaborator or the JV that has not expired or been held invalid or unenforceable by a court of competent jurisdiction in a final and nonappealable or non-appealed judgment, or (ii) the Product or the indication for the Product enjoys market exclusivity by reason of any statute, regulation, rule or order of a governmental authority in the country.
Market Exclusivity means, on a country-by-country basis and an Indication-by-Indication basis, the status in which, and the period during which, either (x) the manufacture, use or sale of the Product would infringe a Valid Claim of the Licensed Patents enforceable in such country in the absence of the license granted herein, or (y) the Product is otherwise legally protected with market exclusivity conferred by the governing authorities of such country (including, but not limited to, the U.S. Xxxxxx-Xxxxx Act or Drug Price Competition and Patent Term Restoration Act or EC Directive 65/65/EEC or 87/21/EEC), provided such legal protection is granted for and based on the Licensed Technology and/or data generated therefrom, as opposed to other intellectual property rights or data covering the Product independent of the Licensed Technology.
Market Exclusivity means that there is no product equivalent to the LICENSED PRODUCT on the market, serving for the same purpose or addressing the same needs of the same customer target group.