definiens: shall mean a Batch of Product that Delivery is more than [ * * * * * ] after the Delivery date specifiedin an accepted Purchase Order, where such a delay in Delivery is due to a cause reasonably under the control of SIGMA - TAU . A Batch will not be considered a Late Delivery to the extent due to:(a ) the lack of availability of a Material, provided SIGMA - TAU has depleted all Safety Stocks;(b ) any changes ( i ) mandated by Governmental Authority or ( ii ) requested by ARADIGM, that cause such delay;(c ) with respect to the [ * * * * * ] Batches Processed by SIGMA - TAU ( including the process validation Batches ), afailure of any such Batches to meet Specifications, provided SIGMA - TAU has, without undue delay, initiatedProcessing of an additional Batch to address the shortfall;(d ) SIGMA - TAU Processing Product in [ * * * * * ] of the Firm Order;(e ) the inability to Release a Batch for which the reason for the Batch not being a Released Batch can not beascribed to a specific cause, provided SIGMA - TAU has, without undue delay, initiated Processing of an additionalBatch to address the shortfall ; or [ * * * * * ] Confidential portions of this document have been redacted and filed separately with the Securities and ExchangeCommission