Market Exclusivity definition

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 a Regulatory Authority with respect to a Product other than patents, including Directive 2001/83/EC and 2004/27/EC (as amended) in the EU and rights equivalent to those

Market Exclusivity means, with respect to a Product in a country, any exclusive marketing right, data exclusivity or other exclusivity status conferred by any Regulatory Authority with respect to such Product in such country, other than a Patent Right, that limits or prohibits a Third Party from (i) relying on pivotal safety or efficacy data generated by or for the Parties with respect to a Product in an application for Regulatory Approval of a product or (ii) commercializing a Product, including orphan drug protection and data exclusivity.

Examples of Market Exclusivity in a sentence

• If a Loss of Market Exclusivity for any Product occurs in any country, then for the remaining period of the Royalty Term following such Loss of Market Exclusivity, the Net Sales for such country [***] for the purpose of the calculation of Royalties due under Section 7.4.1 will be reduced by [***].

• Subject to 11.7.3 (Cumulative Effect of Royalty Reductions), on a Product-by-Product and country-by-country basis, if an event of a Loss of Market Exclusivity for a Product in any country has occurred, then the Royalties due to HMI pursuant to Section 11.7.1 (Royalty Rates) with respect to such Product in such country will be reduced by [***]%.

• Grabowski & Margaret Kyle, Generic Competition and Market Exclusivity Periods in Pharmaceuticals, 28 MANAGERIAL & DECISION ECON.

• Notwithstanding the other provisions of this Section 1.5(a)(i), for any period during the Sales Related Payments Term in which there has occurred Loss of Market Exclusivity with respect to any Product in any country, the Net Sales of Buyer and its Affiliates for such country to be included in [***] worldwide Net Sales for the purpose of the calculation of the Sales Related Payments due under this Section 1.5(a)(i) shall be reduced by [***] of such Net Sales.

• During the period of the Royalty Term where only Market Exclusivity remains, on a country-by-country and Product-by-Product basis, the royalty rates payable on Net Sales of such Product within such country of the Territory shall be reduced by [*].

More Definitions of Market 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, on a country-by-country basis, the period of time during which there is no product containing CG-5503 being sold by a Third Party, other than Affiliates, in the OMP Territory, excluding such product containing CG-5503 from such Third Parties for which claims of infringement according to Section 7.9 have not led to a final, non-appealable decision of a court and such claims of infringement are continuing to be pursued in court.

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, as to a given country, a given product and a given time period, that no Generic version of such product is then being sold in such country.

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 shall have the meaning set forth in Section 4.5(a)(i).

Market Exclusivity means, with respect to a given Product in a given country, that no product sold by a Third Party in such country has Regulatory Approval from the governing Regulatory Agency for such country to be substituted for such Product as therapeutically equivalent (both bioequivalent and pharmaceutically equivalent).