Generic Entry definition

Generic Entry with respect to a Product, means the initiation of sales to wholesale or retail customers of one or more Generic Versions of such Product (other than an Authorized Generic) in the Territory by a Third Party, including an ANDA Settlement Distributor, but excluding any Authorized Generic Distributor.

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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.
Until the third anniversary of the Initial Sale Date (or, if earlier, the date of Generic Entry), Purchaser shall structure and effect the compensation, including incentive compensation, of its Sales Representatives in such a manner so as not to discriminate against the allocation of calling effort described in the then applicable Marketing Plan or the Product and/or any Additional Product.
Either Party may, by 90-days prior written notice to the other Party, terminate this agreement upon the first Generic Entry in the Territory.
Buyer shall not, and shall cause its Affiliates not to, and shall use commercially reasonable efforts to cause its licensees, sublicensees and distributors not to, directly or indirectly, Exploit (i) until the AG Abandonment Date, the Authorized Generic Product and (ii) until the Atacand Generic Entry Date, any Atacand Other Authorized or Owned Generic Product, in each case, in the Territory or outside the Territory.
In the event of Generic Entry with respect to a Royalty Product or a PTB Royalty Product in any country in the Territory, then the royalty rates applicable to Net Sales of such Royalty Product or PTB Royalty Product in such country in accordance with Section 2.8(d)(i)(A) or (B), as applicable, shall be reduced by fifty percent (50%).

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 the commercial launch of a pharmaceutical product (other than the Licensed Product) in a country in the Licensed Territory that (a) is sold by a Third Party other than a Sublicensee and such sale is not directly or indirectly authorized by Licensee or its Affiliates or Sublicensees in breach of this Agreement, (b) is authorized for commercial marketing and use in such country in one or more of the indications for which the Licensed Product has Regulatory Approval in such country, and (c) either (i) is a product approved by way of an abbreviated regulatory mechanism by the Regulatory Authority in such country that, in each case, meets the equivalency determination by the applicable Regulatory Authority; or (ii) contains the same active ingredient as the Licensed Product.

Generic Entry has the meaning set forth in Section 2.3.3.

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, 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.