definiens: means the occurrence of one or more of the following events or circumstances : ( a ) conducting orcontinuing human studies involving the Target Product is non - compliant with applicable Laws ; ( b ) the Target Product is no longerprotected by ( c ) written correspondence from the FDA that would cause a reasonable person in theindustry to conclude the P188 NDA will require clinical trials enrolling more than 499 patients ; ( d ) Dr. Martin Emanuele’svoluntarily termination of employment with Acquiror prior to submission of the P188 NDA to the FDA, or his employment beingterminated for Cause ; ( e ) failure to achieve the primary endpoint definition in the Sole Pivotal Trial or the Subsequent Pivotal Trial, if applicable ; and ( f ) any other event or circumstance that Acquiror and a representative of Target mutually agree constitutes a which Target representative would be Dr. Martin Emanuele or an alternative representative reasonablyacceptable to Acquiror