definiens: shall mean any human clinical trial of a Drug Candidate or Product ( i ) conducted in compliance with a clinical trial protocol submitted by [COMPANY] and approved by the FDA ( or equivalent foreign regulatory agencies ) ; and ( ii ) conducted by or on behalf of [COMPANY], its Affiliate or any Licensee, except to the extent such participation is prohibited by law ( provided that [COMPANY] shall use commercially reasonable efforts to enable such patients to be enrolled in such trial ) . In the event that a SMA patient identified by the Foundation or any licensed physician treating SMA patients does not meet the enrollment criteria for a [COMPANY] Clinical Trial, [COMPANY] agrees to work with the Foundation to establish a compassionate use program in which such SMA patients may gain access to the Drug Candidate or Product ; PROVIDED HOWEVER, that treatment of any SMA patients under such compassionate use program ( i ) must be conducted by a licensed physician experienced with SMA patients ; ( ii ) must be compliant with all applicable laws ; and ( iii ) must not adversely affect the ability to gain /regulatory approval of a Product as a result of the [COMPANY] Clinical Trials