definiens: means purified bulk conjugated antibody known by CYTOGEN as CYT 356 ; 2.26 means development-, upscaling-, cell banking-, manufacturing- and validation activities, and providing regulatory support, by [COMPANY] Biologics, comprising of Step 1, Step 2, Step 3, Step 4, Step 5 and Step 6 as further described in the Schedule annexed hereto and being a part hereof, and all amendments thereto, to be agreed upon bet\veen the Parties ; 2.27 means the individual assigned by [COMPANY] Biologics who will be responsible for the scientific management and technical components of the Project ; 2.28 nleans that, after Product has been manufactured in Step 5, the Product meets the Specifications and was nlanufactured according to cGMP and the Manufactuting Instnlctions ; 2.29 means the speci fications, technical data and/or fomlulae of the Product manufactured in Step 5, and all amendnlents thereto, to be agreed upon between the Parties ; 2.30 means a cOlnmittee with an equal nUlnber of representatives fronl each Party ; 2.31 means developing a Process under non - cGMP conditions by adapting the CYTOGEN Product cell line to a senlm free nledia formulation and by performing upstream and downstream development activities, including a seven ( 7 ) liter fermentation run and a fifty ( 50 ) liter so called pilot fermentation with a lab scale do\vn stream processing step and conjugation ; 2.32 means transfer, development and optimization ofCYTOGEN quality control assays ; 2.33 means preparing under cGMP conditions a master cell bank and a manufacturer working cell bank 4, 2.34 means using the Process as developed in Step I to perfonn at fifty ( 50 ) liter scale, under non - cGMP conditions, one ( I ) so call ed shakedown run including one ( 1 ) conjugation ; 2.35 means cGMP manufacturing three ( 3 ) batches of Product using the Process for a Biologics License Application ( BLA ) supplement and market distribution ; 2.37 means : i ) writing a Process and assay master validation plan and subsequently executing this plan during the perfonnance of Step 5 ; ii ) means providing support for CYTOGEN 's preparation of a chemistry manufacturing and control ( CMC ) data package for filing the Process for a United States BLA supplement and a European Marketing Authorization Application ( MAA ) supplement