definiens: and shall be interpreted accordingly ; 1.1.41 means the documentation generated by · [COMPANY] to enable [COMPANY] 's employees to perfonn the Manufacture of Product ; 1.1.42 means the date agreed by the parties ' " pursuant to Clause 9 on which the Manufacture of a Batch of Product will commence pursuant to a Binding Order ; 1.1.43 means a marketing approval application made to the EMEA ; 1.1.44 means, in respect of each of the BPMSS and BPMLS, that the facility is structurally complete and has been commissioned for use ; 1.1.45 means derivatives of polyethylene glycol, including chemical modifications of polyethylene glycol, that may be used in the Manufacture of Product ; 1.1.46 means all non - cGMP work perfonned at a scale of operation that is less than that of the scale at which Product shall be Manufactured, but not less than a nominal fennenter volume of 20L ; 1.1.47 means the series of proprietary methods and techniques by which Product is Manufactured from a Cell Line in accordance with cGMP, as further defined in the cGMP Batch Records ; 1.1.48 means a document written by [COMPANY], based on the Technology Transfer infonnation provided by [COMPANY], that details the experimental steps that [COMPANY] shall perform to establish the Process in [COMPANY] 's facilities at Pilot Scale, and that specifies some of the criteria against which successful Technology Transfer shall be measured ; 1.1.49 means a document written by [COMPANY] that details the experimental work perfonned by [COMPANY], according to the Process Protocol, to establish the Process in [COMPANY] 's facilities ; 1.1.50 means any Conjugated or non Conjugated antibody fragment produced by microbial recombinant technology and Manufactured in bulk fonn under this Agreement in accordance with the Process ; 5 ........... DeltaView comparison ofiManageDeskSite:/INYDMSOIINYDOCSl115899811 and iManageDeskSite:/INYDMSOIINYDOCS / I158998/2 . Perfonned on 6/21/2004