definiens: or shalllmean thefirstinvoiced commercial saLebyTMC, itsAffiliates, sub - licensees ordistributors, however notincluding salesmade byonesuchentity toanother suchentity, oftheProduct inacountryfollowing NDA Approval insuchcountry.561.24 . shallmean technical andother information, which isnotsubjecttopublished patent rights andwhich isnotinthepublic domain, including, butnotlimited to, information comprising orrelating toconcepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, assays, researchplans, procedures, designs forexperiments andtestsandresults ofexperimentation andtesting, including results ofresearch ordevelopment, processes, including manufacturing processes, specifications andtechniques, laboratory records, chemical, pharmacological, toxicological, clinical, analytical andquality control data, trialdata, casereport forms, dataanalyses, reports, manufacturing dataorsummaries andinformation contained insubmissions toandinformation fromethical committees andregulatoryauthorities . Know - How includes Documents containing Know - How, includingbutnotlimited toanyrights including trade secrets, copyright, database ordesign rights protecting suchKnow - How . Thefactthatanitemisknown tothepublic shallnotbetaken topreclude thepossibility thatacompilationincluding theitem, and/or adevelopment relating totheitem, isnotknown tothepublic