definiens: ( asusedintheterms, and ) means either ( i)holding50%ormore ofthevoting securities ofsuch Person or,(ii)inthecaseofaPerson thathasnooutstanding votingsecurities, having theright to50%ormore oftheproﬁts ofsuchPerson orhaving theright intheevent ofdissolutionto50%ormore ofthenetassets ofsuchPerson or,(iii)thepower todirect orcause thedirection ofthemanagementandpolicies ofsuchPerson, whether pursuant tothe ownership ofvoting securities, bycontract orotherwise;%easelIControlCosts ofProductionDelivery AddressDINDocumentationEffective DateFacilityNetProﬁtNetSalestheability todirect theaffairs ofanother whether bytheownership ofshares, contract orotherwise;thedirect costs ofrawmaterials andlabour andmanufacturing overheads ( which willnotexceed 15%ofthetotalCosts ofProduction ) incurred directly inthemanufacture ofProduct, excluding packaging, ineach caseasaudited andapproved byGENPHARM;GENPHARM ’s premises at85Advance Road, Etobicoke, Ontario, Canada M8Z 2S9;means theexisting generic cross - referenced Product drugidentiﬁcation number assigned byTPD ( asdeﬁned below)alltechnical information anddatarelating totheProduct, including thechemistry, manufacture, use, formulation andregulatory approval thereof, theretofore orhereafter duringtheterms ofthisAgreement produced orreceived byorknown toORBUS oritsAfﬁliates relating totheTerritoryincluding, without limiting theforegoing, thechemistry andmanufacturing dataanddocumentation ( including thedrugmaster ﬁlefortheactive pharmaceutical ingredient ) tobeincluded intheAbbreviated New Drug Submission tobeﬁledbyGENPHARM withtheTPD ( asdeﬁned below),which current dataandinformation, willbesufﬁcient toobtain aNotice ofCompliance from theTPD;thedateofthisAgreement;ORBUS ’s facility inMarkham, Ontario orsuch otherfacility approved byGENPHARM andused inconnectionwiththemanufacture andbulkpackaging oftheProduct;isequal toNetSales lesstheCosts ofProduction