definiens: means ( i ) results demonstrating in [ three ( 3 ) consistency runs ] a ) the ability to grow cells expressing an E Compound in [ perfusion ] cultures for [ thirty ( 30 ) days ], and maintain an [ overall cell viability aoove eighty percent ( 8U% ) ], and b ) the ability to reach the [ production phase within eight ( 8) days of inoculation ] followed by at least [ twenty ( 20 ) days of stable production ] of an E compound in a bioreactor working volume of at least [ five ( 5 ) liters ], and ( c ) [ superimposable growth curves, Product productivity curves and cell viability curves between the consistency runs ], and ( d ) the ability to purify an E compound with at least a [ two - fold higher ] final recovery yield per [ 30 - day perfusion culture ] campaign as compared to the recovery yield described in with a consistent Product quality in terms of [ gamma carboxylation, gJycosylation and isoforms ], and ( e ) complete written documentation through Standard Operating Procedures for the [ perfusion culture process and the purification ] process ; or ( ii ) a decision by [ [COMPANY] ] to utilize [ a perfusion ] process to manufacture a Product for Phase III clinical trials and commercial use