definiens: means all documentation, reports, case report forms, data, information and the like, including all notes, summ aries and analyses related thereto, in whatever form or media, in the possession or Control of Collegium or any Affiliate thereof, which result from or otherwise describe ( i ) pre -clinical, clinical, or other research and development activities related to a ny Licensed Product conducted by or for Collegium, its Affiliates, or any Sublicensees in the Territory, including but not limited to Phase IV Studies or manufacturing - or formulation -related activities, and/or any results thereof, ( ii ) information obtaine d by or on behalf of Collegium or Affiliate thereof concerning the use or administration of Licensed Products, including but not limited to AEs, ADRs, ADEs, and/or SAEs, or ( iii ) or other Collegium Know -How contained or referenced in any Governmental Appro vals or Regulatory Filings