Market Exclusivity definition

Market Exclusivity means an exclusive benefit by grant or an exclusion under or from any Regulatory Authority relating to the Licensed Product.

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, 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 [*].

Examples of Market Exclusivity in a sentence

• 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.

• For purposes of illustrating the immediately preceding sentence only, if the aggregate [***] Net Sales of Buyer and its Affiliates for [***] in a country in which Loss of Market Exclusivity has occurred are [***], Novartis would be entitled to receive Sales Related Payments calculated as follows: [***] x US$[***] (or US$[***]) [***] (or [***]) = US$[***].

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

• 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 [***].

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

More Definitions of Market Exclusivity

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.

Market Exclusivity means any orphan drug-based exclusive marketing rights conferred by any Regulatory Authority with respect to a Licensed Product in a country in the Licensed Territory, including orphan drug exclusivity rights conferred by the U.S. Food and Drug Administration (FDA) or any rights equivalent thereto conferred by any Regulatory Authority in any other country in the Licensed Territory.

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).

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 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.

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 any data or market exclusivity periods, including any such periods listed in the FDA’s Orange Book or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 and all foreign equivalents thereof.