definiens: means, with respect to a Product either ( i ): ( a ) a demonstration of [ comparable glycan structures, gamma - carboxylation patterns, activity and final yield ] between Products made [ in lab - scale consistency runs, scale - up development batch(es ) and at least two ( 2 ) identical batches at final scale ] for manufacturing of clinical material for Phase I clinical trials and Phase II clinical trials ; and ( b ) [ unanimous ] decision [ by the JMC ] to initiate cGMP production of a Product having acceptable [ drug substance stability ] ' as demonstrated by [ accelerated stability data indicating that the Product, formulated in a clinically acceptable formulation, is reasonably likely to maintain at least ninety percent ( 90 % ) ] activity for at least [ twelve ( 12 ) months ] at the target storage temperature ; and ( c ) [ unanimous ] decision [ by the JMC ] to file an IND for the applicable Product, and all [ API and DP ] needed for Phase I clinical trials is produced and released to allow EIH ; or ( ii ) EIH, if such EIH occurs for [ B0189 ] or before [ June 30, 2008 ], or such EIH occurs for [ B0178 ] on or before [ December 31, 2009 ], unless prior to the applicable date, [ the JMC ] makes a [ unanimous ] decision to allow EIH, even if all the conditions in ( i ) above have not all been met, provided in such case, a Satisfactory [ CMC ] Result shall not be deemed to have been achieved until all the requirements in ( 1 ) above have been achieved ( or equivalent data has been generated, as [ [COMPANY] in its reasonable discretion ] deems appropriate ), which may occur after the applicable date described above