Loss of Exclusivity definition

Loss of Exclusivity means the loss of exclusivity in any country in Territory A upon the occurrence of all of the three following conditions: (i) a Clopidogrel Product shall have lost its marketing exclusivity (whether by virtue of compulsory license under, or expiration, invalidity or unenforceability of, the patents covering such Clopidogrel Product, loss or expiration of any exclusivity conferred de facto or de jure by any statutory marketing or data exclusivity or any other cause), (ii) one or more Competing Products shall have been legally marketed in such country by one or more Third Parties and (iii) IFRS Net Sales of such Clopidogrel Product in such country over any period of [*] (after the conditions set forth in sub-clauses (i) and (ii) above shall have been satisfied) shall have [*] the level of IFRS Net Sales of such Clopidogrel Product in such country over the immediately preceding period of [*]

Loss of Exclusivity means, with respect to a Milestone Product that is being marketed or sold in a given country, a condition in which one or more Third Parties launches, sells or otherwise distributes a Generic Product in such country, and such Generic Product accounts for [***] ([***]%) or more of aggregate sales of [***] and [***] in [***] in [***] or [***] to be mutually agreed between Buyer and Seller [***] and [***] to be mutually agreed between Buyer and Seller [***] in [***].

Loss of Exclusivity means expiration of the period for which the applicable Product has marketing exclusivity pursuant to 21 C.F.R Section 314.108.

Examples of Loss of Exclusivity in a sentence

• For the avoidance of doubt, with respect to any instance of Loss of Exclusivity for a particular XXX Milestone Product in a particular XXX Country, there shall be no reduction in any Initial Sales-Based Payments and/or Sales-Based Payments for any other Milestone Products in such XXX Country nor shall there be any reduction in any Initial Sales-Based Payments and/or Sales-Based Payments for such XXX Milestone Product in any country other than the applicable XXX Country.

• The ​ Milestone Notice shall include (A) with respect to the Milestones in Table 3.2(a)(i), Buyer’s good faith determination of the amount of Net Sales for the applicable measurement period and the corresponding Milestone Payment, with reasonable details and supporting materials in respect of such calculations set forth in the Milestone Notice, and (B) with respect to the Milestones in Table 3.2(a)(ii), whether or not there exists a Loss of Exclusivity as of the relevant date(s) set forth in such table.

• Section 9.4 Loss of Exclusivity; Cessation of Sales; Cessation of Services...........................

• In the event that one of the parties notifies the other party that it has reasonably determined that an R&D Loss of Exclusivity has occurred, the parties will discuss in good faith to determine whether it is advisable to reduce or otherwise modify the parties’ research and development obligations and commitments pursuant to Sections III(G)(1), IV(C)(4), IV(C)(5), IVa(C)(4) and IVa(C)(5) (collectively, the “R&D Commitments”).

• Commencing with the Calendar Year in which Loss of Exclusivity occurs and continuing until the expiry of the Royalty Term, Buyer shall, shall cause its Affiliates that are Contingent Payment Obligors to, and shall use commercially reasonable efforts to cause the other Contingent Payment Obligors to, use its and their, as applicable, Commercially Reasonable Efforts to Exploit the Products.

More Definitions of Loss of Exclusivity

Loss of Exclusivity means, with respect to any Earn-Out Product, the later of (a) the last to expire of any Valid Claim of any Earn-Out Patent Right covering such Earn-Out Product (as such Earn-Out Patent Right may be extended by any eligible extension, including a patent term extension) and (b) expiration of Regulatory Exclusivity of such Earn-Out Product (in each case, excluding any pediatric extension).

Loss of Exclusivity means the loss of exclusivity of a Product in any country in Territory B upon the occurrence of both of the following conditions: (i) such Product shall have lost its marketing exclusivity (whether by virtue of compulsory license under, or expiration, invalidity or unenforceability of, the patents covering such Product, loss or expiration of any exclusivity conferred de facto or de jure by any statutory marketing or data exclusivity or in any other cause) and (ii) one or more Competing Products shall have been legally marketed in such country by one or more Third Parties.

Loss of Exclusivity means the loss of exclusivity in any country in Territory A upon the occurrence of all of the three following conditions: (i) a Clopidogrel Product shall have lost its marketing exclusivity (whether by virtue of compulsory license under, or expiration, invalidity or unenforceability of, the patents covering such Clopidogrel Product, loss or expiration of any exclusivity conferred de facto or de jure by any statutory marketing or data exclusivity or any other cause), (ii) one or more Competing Products shall have been legally marketed in such country by one or more Third Parties and (iii) Net Sales of such Clopidogrel Product in such country over any period of [*] (after the conditions set forth in sub-clauses (i) and (ii) above shall have been satisfied) shall have [*] the level of Net Sales of such Clopidogrel Product in such country over the immediately preceding period of [*].

Loss of Exclusivity means the loss of exclusivity of a Product in any country in Territory A upon the occurrence of all of the three following conditions: (i) such Product shall have lost its marketing exclusivity (whether by virtue of compulsory license under, or expiration, invalidity or unenforceability of, the patents covering such Product, loss or expiration of any exclusivity conferred de facto or de jure by any statutory marketing or data exclusivity or any other cause); (ii) one or more Competing Products shall have been legally marketed in such country by one or more Third Parties; and (iii) Net Sales of such Product in such country over any period of [*] (after the conditions set forth in sub-clauses (i) and (ii) above shall have been satisfied) shall have [*] the level of Net Sales of such Product in such country over the immediately preceding period of [*]).

Loss of Exclusivity means, on a country-by-country basis, the expiration of the last-to-expire Bayer Patent that includes a Valid Claim that covers a Collaboration Product sold in such country, possession or territory and, additionally, shall be deemed to have occurred (a) as of the Effective Date on a country-by-country basis in such countries where no Bayer Patent that includes a Valid Claim that covers the Collaboration Product sold in such country exists or (b) in the event a Third Party is granted (i) a license or sublicense as a result of a settlement by Bayer of any action taken in a court or Governmental or Regulatory Authority, or (ii) a compulsory license granted pursuant to Applicable Law or any action taken by a court or Governmental or Regulatory Authority; and “Valid Claim” shall mean a claim of a pending patent application or an issued and unexpired patent, which has not been held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction, which holding is unappealable. For purposes of this Agreement, “Loss of Exclusivity” shall be deemed to have occurred as of the date on a country-by-country basis in such countries where no Bayer Patent that includes a Valid Claim that covers the Collaboration Product sold in such country, possession or territory exists. “Bayer Patent” means the patents listed in Appendix B hereto.

Loss of Exclusivity means, with respect to a Product, the first date after the Closing Date on which no Valid Claim covers such Product or the Manufacture or Exploitation of such Product in the Territory.

Loss of Exclusivity means, with respect to a Product in a country, a Generic Product with respect to such Product is launched, and such Generic Product and any other Generic Products of such Product in such country capture more than [***] in such country.