definiens: means with respect to the Dedicated Production Line, the maximum number ofBatches that can be produced in any 12 - month period ( assuming overlappingconsecutive runs after process validation ), which, unless otherwise mutuallyagreed by the Parties in writing, shall be:(a ) [ … * * * … ] Batches during the period from completion of the last ProcessValidation Batch until the earlier of ( i ) the [ … * * * … ] anniversary of FirstApproval and ( ii ) expiration of the [ … * * * … ] Request Period ( as defined inClause 9.2);(b ) [ … * * * … ] Batches during the period from expiration of the [ … * * * … ] RequestPeriod until the earlier of ( i ) the [ … * * * … ] anniversary of First Approval and(ii ) expiration of the [ … * * * … ] Request Period ( as defined in Clause 9.2)(c ) [ … * * * … ] Batches during the period from expiration of the [ … * * * … ] RequestPeriod until the [ … * * * … ] anniversary of First Approval ; * * * Confidential Treatment Requested 6CONFIDENTIAL in each case, subject to : ( x ) pro rata adjustment for any 12 - month period duringwhich the Batch production level increases or decreases as described inClause 3.3 ; and ( y ) reduction in the event of Customer ’s exercise of its right todecrease the Batch production level in accordance with Clause 3.3.6