Loss of Market Exclusivity means, on a [***], (a) one or more Generic Products for which such Product is the reference product are being marketed in such country; and (b) Net Sales of such Product in such country in any Calendar Quarter following the initial sale of the first such Generic Product(s) in such country decreases to less than [***]% of the average Net Sales of such Product in such country during the [***] Calendar Quarters preceding the initial sale of such Generic Product(s).
Loss of Market Exclusivity means, with respect to any Licensed Product in any country or jurisdiction in the Territory, that: (a) [***] Generic Versions of such Licensed Product has been sold by any Third Party (other than a permitted sublicensee of Gilead) in such country or jurisdiction; and (b) units of such Generic Version(s) sold in that country or jurisdiction during any [***] represent at least [***] of the sum of: (i) units of such Generic Version(s) and (ii) units of such Licensed Product, sold in that country or jurisdiction during such [***].
Loss of Market Exclusivity means, with respect to any Product in any country, the Net Sales of such Product in that country in any Calendar Year are less than [***]% as compared with the Net Sales of such Product in that country in the Calendar Year immediately preceding the marketing or sale of the first Generic Equivalent of such Product.
Examples of Loss of Market Exclusivity in a sentence
In the event of a Loss of Market Exclusivity in any country, then the royalty rates applicable to Net Sales under Section 8.5(a) and (b) of such Product in such country shall be reduced by [ * ] percent ([ * ]%).
On a country-by-country basis, if a Loss of Market Exclusivity has occurred in such country, Net Sales of the Products in such country shall be reduced by [***] percent ([***]%) and the Participation Payment owed to the Buyer shall be calculated based upon such reduced amount.
More Definitions of Loss of Market Exclusivity
Loss of Market Exclusivity means, with respect to any Product in any country, the following has occurred: (i) the sale of such Product in such country is not covered by a Valid Claim of any Patent owned or controlled by Buyer, its assignees or their respective Affiliates, (ii) such Product is not subject to regulatory, data or marketing exclusivity (or similar period of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential Treatment has been requested with respect to the omitted portions. exclusivity granted by any Governmental Authority) under Applicable Law, and (iii) the Net Sales of such Product in that country in any calendar year are less than [***] as compared with the Net Sales of such Product in that country in the calendar year immediately preceding the marketing or sale of the first Generic Equivalent of such Product.
Loss of Market Exclusivity means, on a Product-by-Product and country-by-country basis, the later to occur of: (a) the expiration of the last-to-expire Valid Claim of a Patent Right covering such Product in such country; and (b) the expiry of all Regulatory Exclusivity Periods for such Product in such country.
Loss of Market Exclusivity means [***]
Loss of Market Exclusivity means, with respect to a Product on a country-by-country basis, the Net Sales of such Product in that country in any Calendar Year are less than [***] as compared with the Net Sales of such Product in that country in the Calendar Year preceding the marketing or sale of the first Biosimilar Product of such Product.
Loss of Market Exclusivity with respect to any Licensed Product in any country, shall be deemed to have occurred only if: (a) one or more Generic Equivalent(s) are being marketed by a Third Party (excluding any Sublicensee) in such country; and (b) Net Sales of such Licensed Product in that country during any Calendar Quarter following introduction of the Generic Equivalent(s) have declined by at least [***] in that country relative to the average quarterly Net Sales of such Licensed Product in such country over [***] ending prior to the introduction of such Generic Equivalent(s) (the “Baseline Net Sales”) and such decline in Net Sales is not primarily attributable to [***]. Anything contained in this Agreement to the contrary notwithstanding, a “Loss of Market Exclusivity” shall not be deemed to have occurred if [***].
Loss of Market Exclusivity means with respect to a specified country in the Territory, the reduction by [***]% or more in any 12-month period in Net Sales of Product due to the sale in such country of any interchangeable pharmaceutical product containing a fumaryl diketopiperazine-based formulation of the same active ingredient as Product, which are marketed by any entity or entities other than United Therapeutics or any of its Affiliates or sublicensees in such country, as compared with the 12-month period immediately prior to the 12-month period in which the sale of any such pharmaceutical product first occurred (as measured by reputable published data, e.g. by reference to market share data collected by IMS).
Loss of Market Exclusivity means, [***].