definiens: means technical and other information which is not in the public domain including informationrelating to : ( i ) non - clinical data including pharmacological, toxicological and metabolic data and results of anynon - clinical studies relevant to the API and the Drug Product ; ( ii ) clinical safety and efficacy data includingdata analyses, study reports and information contained in protocols, filings or other submissions to orresponses from ethical committees and Drug Regulatory Authorities ; ( iii ) pharmacovigilance data;(iv ) production processes including any drug master file, specifications, techniques, manufacturing lineprocedures, CMC data, SOPs, quality analysis and quality control processes and techniques and otherdocumentation retained to comply with GMP ; and ( v ) any relevant information relating to product supply chainof the Drug Product including the API, fill, finish and primary and secondary items . Know How includes:(a ) documents containing Know How ; and ( ii ) any legal rights including trade secrets, copyright, database ordesign rights protecting such Know How ; 1.45 shall have the meaning set out in Clause 7.19 ; 1.46 or shall mean Patent Rights, Know How, copyrights, any improvements, enhancements or modifications to any of the foregoing and any rights or property similar to any of theforegoing in any part of the world, whether registered or not ; 1.47 or shall mean the joint steering committee having the role specified inClause 8