definiens: means all Theravance Confidential Information and Theravance Know - Howrelating to : ( 1 ) the lead Theravance Compound in the relevant Alliance Program, as well as any back - up and follow upTheravance Compound for which Theravance in good faith believes there is sufficient in vivo data and which are part of suchAlliance Program ; ( 2 ) where applicable, all information regarding the bulk drug substance and finished dosage form(s ) andmethods of manufacturing the same, including without limitation analytical methods ; and ( 3 ) the full disclosure of allinformation relating to the lead Theravance Compound and any such back - up Theravance Compound ( including, whereapplicable and without limitation, clinical and protocol results, analytical methodologies, bulk and final productmanufacturing processes, batch records, pre - formulation studies, reports summarizing development pharmaceutics, vendorinformation, validation documentation, regulatory documentation, patent information ), regulatory filings, transfer ofinformation related to regulatory information and filings, pre - clinical and clinical data, adverse event data, regulatorycorrespondence ( including records of meetings and telephone conversations ), analyses, and manufacturing data