definiens: means [ * * * ] 1.54 or means all activities covering research, non - clini cal, preclinical and Trials ( including Trial recruitment and Trial site engagem ent ), toxicology testing, companion diagnostics dev elopment, statistical analysis and reporting, all the aforeme ntioned regarding the Licensed Antibody and/or the Product in any country or jurisdiction in the world in the Fie ld and being necessary or reasonably useful or requ ested or required by a Regulatory Authority or as a conditio n or in support of obtaining or maintaining any or all Regulatory Approvals for the Licensed Antibody and/ or Product in any country or jurisdiction in the wo rld in the Field . For clarity, and sha ll include Post - Marketing Authorization Trials that are required by or committed to Regulatory Authorities but shall not include any activities covering Commercialization or Manufacture or other Regulator y Activities