Generic Entry definition

Generic Entry means, with respect to a particular country, market entry (i.e., product launch and/or continued sale) of a third party (other than a licensee or sublicensee of Buyer or its Affiliate) Generic Product in such country.

Generic Entry shall have the meaning set forth in Section 8.5.1(iii).

Generic Entry shall be deemed to exist in a particular country of the Territory for a particular Product as of the earlier of the first date upon which a Generic Product with respect to such Product has been sold in such country.

Examples of Generic Entry in a sentence

• For the avoidance of doubt, for a year in which a U.S. Generic Entry Impact occurs, (x) U.S. Licensee will pay U.S. Royalty Consideration to Licensor with respect to the portion of such year prior to the date of such U.S. Generic Entry Impact and (y) no U.S. Royalty Consideration will be due with respect to any date thereafter.

• Jin Xie & Joseph Gerakos, The Anticompetitive Effects of Common Ownership: The Case of Paragraph IV Generic Entry, 110 AEA PAPERS & PROC.

• Figure 1: From Patent Application to Generic Entry An increase in generic substitution has been achieved through the enforcement of theDrug Expenditure Restriction Act in February 2002, introducing the Aut-idem regulation for 13See also EUC (2008), p.

• New Drug Formulations and Their Respective Generic Entry Dates, JMCP.

• They further agreed: “For the avoidance of doubt, all the Generic Entry Dates in this Paragraph 1.2 are subject to any regulatory exclusivity to which the First Filer is entitled.” Id. at 18.

More Definitions of Generic Entry

Generic Entry means [ * ].

Generic Entry means the earliest time at which, for the then most recently completed three (3) consecutive calendar months, the aggregate number of prescriptions filled for generic forms of the Product and any Additional Products sold by third parties in the Territory constitutes at least [***] percent ([***]%) of the aggregate total number of prescriptions filled for the Product, any Additional Products and any generic versions thereof made available in finished form in the Territory.

Generic Entry means the first commercial sale of a product following final approval by the FDA under section 505(j) of the FD&C Act of an application for such product that identifies the Product as a reference listed drug in the application.

Generic Entry means, on a country-by-country basis in the Territory, that following the Generic Launch Date of such Generic Product, the average Net Sales of the Licensed Product have declined in any [***] ([***]) consecutive Calendar Quarters by greater than [***]% compared to the average Net Sales of the Licensed Product during the [***] ([***]) consecutive Calendar Quarters completed just prior to the Generic Launch Date.

Generic Entry means the end of the two (2) consecutive calendar quarter period during which one or more third parties have sold a number of units of a Generic Version of the Product in a certain country equal to or greater than [*] of the total unit sales of such Product and such Generic Version in such country in the same period, taken together in the aggregate.

Generic Entry means, with respect to any Product in any country, that a Generic Equivalent of such Product has been Launched by a Third Party and Net Sales of such Product in such country for any calendar quarter thereafter have fallen by fifty percent (50%) from the average quarterly Net Sales of such Product in such country over the last four (4) complete calendar quarters ending prior to such Launch and such decline in Net Sales is directly attributable to the marketing or sale in such country of such Generic Equivalent in such country.

Generic Entry means, with respect to a Product and country, the first sale of a Generic Product.