definiens: means one or more of the following events orcircumstances occurred in Development or Manufacturing or regulatory conditions relating to theAlbireo Compound or a Product that delays the further Development of a Product or results indelayed achievement of the enrollment of the first human subject in Japan in any clinical trial, including, without limitation, a Phase I clinical trial, by [ * * * ], provided that such events orcircumstances were not caused by the negligent act or omission of [COMPANY], its Sublicenseesor any of its Affiliates : ( i ) the clinical trial of the [COMPANY] Compound or Product is [ * * * ] ; ( ii ) [ * * * ] difficulties, with respect to [ * * * ], for which [COMPANY] receives written notice from [COMPANY] within [ * * * ] of becoming aware of such difficulty ; ( iii ) [ * * * ] difficulties due to ( A ) incomplete conduct ofactivities undertaken by [COMPANY] under the Territory Development Plan, for which Albireoreceives written notice from [COMPANY] within [ * * * ] of becoming aware of such incompleteness,(B ) [COMPANY] ’s notice pursuant to Section 4.1.4 which delays or withholds a Territory Study for aperiod greater than [ * * * ], or ( C ) [ * * * ] by [COMPANY], the adverse effects of which [ * * * ], in whole or inpart, uncured by [COMPANY] [ * * * ] after [COMPANY] ’s receipt of notice from [COMPANY] alerting [COMPANY] tosuch inadequacy ; or ( iv ) [COMPANY] ’s breach of this Agreement, which breach remains uncured for [ * * * ] measured from the date written notice of such breach is given to [COMPANY] by [COMPANY]