definiens: means the occurrence of any of the following, provided that the occurrence materially and adversely affects ZB Dental 's ability to Distribute the Product and was not caused by any act or omission of ZB Dental, its Affiliates or its Qualified Marketing Partners : ( i ) any claim, action or litigation ( e. g., patent or professional liability ) relating to the Products or this Agreement ; ( ii ) any occurrence, condition or development ( including a Field Action ) that reasonably calls into question the safety or efficacy of the Product or might reasonably pose a substantial legal liability on ZB Dental if ZB Dental continued Distribution of the Product ; ( iii ) any circumstance beyond ZB Dental 's control that results in ZB Dental being prohibited under Applicable Laws from Distributing the Product ( e.g., patent infringement injunction, or the FDA or other Regulatory Authority withdraws, suspends, or fails to grant, Regulatory Clearance ) ; ( iv ) a Force Majeure Event ; or ( v ) AcelRx 's material breach of this Agreement, including AcelRx 's failure to supply the Product or failure to offer or enable ZB Dental to offer Customer or Sales Representative training in a timely manner