definiens: shall mean the manUfacture ( unit dose filling, bulk labeling ( including, at minimum, laser printing eac~ ~ial wit ? unique identificati ~ n and batch num?er ), ? ulk packaging, a ~ d quality control testing ( i.ncluding in - process, release, and * stablhty testmgflof the Product m accordance With thiS Agreement . It IS understood by the parnes hereto ' that SP Ltd. shall be responsible fo{t'inish packaging and finish labelinj It is also understood by the parties that Product supplied for the EU Countries * mustlliave a .~ertificate of analysis ( or comparable release document ), from an EU test site, indicating that it meets the EU Product * Specificati0n;J 1.15 The tenn shall mean a therapeutic vaccine for the treatment or prevention ofucurrence of * malignant melanoma)in humans which comprises as a first component affiomogeneous mixture o]melanoma celllysatelfrom Mel - S * and Mel - D cell linei\and a second component, Detox ™ immunostimulant [ 3 - 0 - deacylated monophosphoryl lipid A ( 3DMLA ) and * cell wall skeleton ( CWS ) ]