definiens: means any product made from a cell line and process which are compatible with manufacture in the SOOO Liter Manufacturing Suite including the monoclonal antibody known as ERBITUX ® ( cetuximab and formerly known as IMC - C22S ) ( including any sample thereof ) . [COMPANY] shall notify LB of any change in the identity or formulation of the then­current Product no later than six ( 6 ) months before the commencement of manufacture . Notwithstanding the foregoing, the Parties understand that any Product to be manufactured in the SOOO Liter manufacturing suite must have a process similar to the production Process for ERBITUX ®, ( i.e. similar fermentation time in the production reactor and a similar purification time . ) . If the production process requires more fermentation time or additional purification time the Batch Price for the Product will be adjusted accordingly . [COMPANY] shall notify LB of the Product and any substitute product no later than six ( 6 ) months before the commencement of manufacture . Before commencement of the campaigns particulars of the Product will be set out in Attachments to this Agreement as amended from time to time in accordance with this Agreement or any new formulation of such antibody