definiens: means all documentation, reports, case report forms, data, information and the like, including all notes, summaries and analyses related thereto, in whatever form or media, in the possession or controlof Purdue or any Affiliate thereof, which result from or otherwise describe ( i ) pre - clinical, clinical, or other research anddevelopment activities directly related to any Licensed Product conducted by or for Purdue, its Affiliates, or anySublicensees in the Territory, including but not limited to clinical studies or manufacturing- or formulation - relatedactivities, and/or any results thereof, ( ii ) information obtained by or on behalf of Purdue or Affiliate thereof directlyconcerning the use or administration of Licensed Products, including but not limited to AEs, ADRs, ADEs, and / orSAEs, or ( iii ) or other Purdue Know - How contained or referenced in any Governmental Approvals or RegulatoryFilings, excluding for greater certainty any Purdue information not related to the Licensed Product or itsCommercialization, use, or manufacture