definiens: means the occurrence of any of the following : ( a ) Generic Competition ; ( b ) anymaterially adverse change to a Trospium Once - Daily Product label such as an FDA - mandated addition of a warning on the Product Labeling of Trospium Once - Daily that is unique to such product among the class of anti - cholinergicdrugs for the treatment of overactive bladder ; ( c ) any recall or withdrawal of Trospium Once - Daily mandated by the FDA orreasonably initiated by a Party ( other than actions arising out of or resulting from the manufacturing of Trospium Once - Dailyon or after the Processing Assumption Date ) ; ( d ) a determination by a court of competent jurisdiction that a patent owned by aThird Party is infringed by the manufacture, use, sale, offer for sale or importation of Trospium Once - Daily in the Territory ; or(e ) failure to deliver at least ( i ) [ ... * * * ... ] of Trospium Once - Daily Finished Product and Samples for receipt by [COMPANY] or itsdesignee by [ ... * * * ... ] ( provided that [COMPANY] provides any modifications requested by [COMPANY] to the trade dress for such FinishedProduct and Samples on or before [ ... * * * ... ], and the FDA does not reject any such modifications to the trade dress, providedthat, if [COMPANY] does not provide such modifications or if the FDA rejects any such modifications to the trade dress, suchdelivery date shall be extended by a period of time equal to the period between [ ... * * * ... ] and the date upon which Espritprovides such modifications or the FDA approves such trade dress, as applicable ), ( ii ) [ ... * * * ... ] ( not including the [ ... * * * ... ] tobe delivered by [ ... * * * ... ], as described in subsection ( i ) above ) of Trospium Once - Confidential treatment has been requested for portions of this document . This copy of the document filed as an Exhibit omitsthe confidential information subject to the confidentiality request . Omissions are designated by the symbol [ ... * * * ... ] . Acomplete version of this document has been provided separately to the Securities and Exchange Commission