definiens: means the occurrence of any of the following : ( a ) Generic Competition;(b ) any materially adverse change to a Trospium Once - Daily Product label such as an FDA - mandated addition ofa warning on the Product Labeling of Trospium Once - Daily that is unique to such product among theclass of anti - cholinergic drugs for the treatment of overactive bladder ; ( c ) any recall or withdrawal of TrospiumOnce - Daily mandated by the FDA or reasonably initiated by a Party ( other than actions arising out of or resultingfrom the manufacturing of Trospium Once - Daily on or after the Processing Assumption Date ) ; ( d ) a determinationby a court of competent jurisdiction that a patent owned by a Third 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 ) * ofTrospium Once - Daily Finished Product and Samples for receipt by Esprit or its designee by * ( provided thatEsprit provides any modifications requested by Esprit to the trade dress for such Finished Product and Sampleson or before *, and the FDA does not reject any such modifications to the trade dress, provided that, if Espritdoes 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 * to bedelivered by *, as described in subsection ( i ) above ) of Trospium Once - Daily Finished Product and Samples by *, and/or ( iii ) * ( not including the * to be delivered by *, as applicable, as described in subsections ( i ) and ( ii ) above)of Trospium Once - Daily Finished Product and Samples by *