definiens: shalllmean eachofNovadaq andIntuitive ( butnottheirrespectiveAffiliates ), whotogether aresometimes referred toasthe AsusedinthisAgeement, references to donotinclude either Party ortheirrespective Affiliates . ' » ( vv ) means ( i)anyandallwritten, oral, andvisual ideas, concepts, andinventions, whether ornotanysuchidea, concept, orinvention hasbeen filed asapatent application orsubmitted bytheir1ventor(s ) toanyattorney orother person forevaluation -astopatentability, ( ii)anypatents, patent applications, anypatents issuing therefrom worldwide, andallprovisional rights withrespect topatent applications, ( iii)anyimprovements, substitutions, divisionals, patents ofaddition, continuations, continuatioris - in - part, reissues, renewals, registrations, conﬁrmations, re - examinations, extensions, supplementary protectioncertiﬁcates, termextensions ( under applicable patent lavvorregulation orother lawor 5regulation ), andcertiﬁcates ofinvention ofanypatents orpatent applications, and(iv)allrightstoexploitany oftheforegoing . _ .*A ( rt ) Theterm shallmean anindividuahcorporation, partnership, limited partnership, limited liability company, unincorporated association, trust, joint venture, union orother organization orentity, including afiovernmental Authority . - i'- .(y ) ' Orders ” -shallmean orders transmitted byIntuitive ( inwritten orelectronic form ), conforming totherequirements ofthisAgreement, andantlroriaing anddirecting [COMPANY] tomanufacture anddeliver speciﬁed Illurninators andICGFluorescenceImaging Agent onspeciﬁed delivery dates . -_(2 ) - shallmean Quality Systems Regulations andGoodMantlfacturing Practices formedical devices anddrugs, aspromulgated orotherwise establishedbyanyGoyermnental Authority governing themethods usedin, andthefacilities andcontrolsusedfor, thedesign, manufacture, packaging, labeling, storage, installation, andservicing ofallﬁnished drugs - and devices intended forhuman use, including those setforth intheFDA ’s iQuality System Regulations in21 - C.F.R. Part320'andtheEuropean Council Directiveconcerning Medical Devices, 93/42!EEC, thenineffect from timetotime