definiens: shall mean all national and local laws, ordinances, rules and regulations as amended, re - enacted or in force from time to time applicable to this Agreement oractivities contemplated hereunder, including the rules and regulations of the relevant Regulatory Authority;2.2For the purposes of this Agreement, shall mean ( i ) any and all information regarding the use offenfluramine obtained in the Study and currently in possession of Institution or subsequently obtained in theStudy related to treatment of patients, whether provided through physician notes, patient self - reporting, clinical monitoring, prescription history, insurance claims, or other forms reducible to electronic ordocumentary records ( such information constitutes Institution ’s Confidential Information ) and ( ii ) the PatentApplication ( as defined in article 2.4 . ) and ( a ) all divisional or continuation, in whole or in part, applicationsbased on the foregoing ( b ) any continuations - in - part in the USA thereof ; ( c ) any and all issued and unexpiredpatents and any further applications resulting from any of the applications described above ; ( d ) any and allissued and unexpired reissues, re - examinations, renewals or extensions based on any of the patentsdescribed in ( c ) above and shall also include the Supplementary Protection Certificates ( SPCs ) and theperiod of protection provides by SPCs ( hereinafter the )