definiens: means the yield of Product that has been agreed by both parties, calculated as set out under Clause 8.1, and below which [COMPANY] may elect not to accept a Batch ; 1.1.2 means this agreement between [COMPANY] and [COMPANY] for performance of the Services and the supply of Product as set out in this document and the Schedules hereto ; 1.1.3 means a document written by [COMPANY], based on the Technology Transfer information provided by [COMPANY], that details the experimental steps that [COMPANY] shall perform to establish the analytical methods in [COMPANY] 's facilities, and that specifies some of the criteria against which successful Technology Transfer shall be measured ; 1.1.4 means a document written by [COMPANY] that details the experimental work performed by [COMPANY], according to the Analytical Method Transfer Protocol, to establish the analytical methods in [COMPANY] 's facilities ; 1.1.5 means the weekly rate for Batches additional to the Reserved Capacity ( including Engineering BatchesBatch " means the total quantity of a Product resulting from a single Manufacturing run, and which is obtained from one or more · · fermentations and associated Downstream Processing, using the Process and carried out in accordance with cGMP ; 1.1.7 means a binding order for Batches to be Manufactured by [COMPANY] as agreed by the parties pursuant to the forecasting and ordering procedure set out in Clause 9 ; 1.1.8 means a biologicals license application made to the FDA or any equivalent application made to any other Regulatory Authority ; 1.1.9 means [COMPANY] 's Biopharmaceutical Manufacturing Large­Scale 15,000L facility ; 1.1.10 means [COMPANY] 's Biopharmaceutical Manufacturing Small­Scale 1,000L facility ; 1.1.11 means a period during which there is a consecutive Manufacture of one specific Product, without interruption for the Manufacture of any other Product or products . Each Campaign shall include two weeks for plant adaptation and cleaning of the relevant [COMPANY] facility as set out in Schedule 1 . This two week period shall be charged, for a Campaign conducted either entirely or partially under the Reserved Capacity, at the mtroductory Rate, and for any other Campaign, at the Base Rate ; 1.1.12 means items of equipment which are additional to the BPMSS and BPMLS ( other than Raw Materials ) and which are required specifically and solely for the Manufacture of Product as identified and agreed by the parties in writing ; 1.1.13 means the collection of vials containing the Cell Line