definiens: means any day which is not a Saturd ay, a Sunday or a German public holiday and references to any time shall be to German time ( GMT+one hour ) ; 1.6 means the cell line as described in Schedule One or any other cell line agreed between the Parties in accordance with Section 3.2 below . Where a strain has been specified in the Sp ecification, references in this Agreement to Cell Line refer to that specified strain ; 1.7 means the recombinant enzyme beta -glucuronidase ; 1.8 means the finishe d dosage form of the Drug Substance ; 1.9 means certain contractual obli gations hereunder, which in case of a breach have the consequences as ascribed to them in this Agreem ent, provided that in case of damages such damages must be caused by negligence or willful misconduct ; 1.10 means Good Manufacturing Practices as regulat ed under the German Pharmaceuticals Act ( ), the German Regulation for M anufacturing of Medicinal Products and Active Ingredients ( Arzneimittel- und Wirkstoffherstellung sverordnung ), and the Guidelines to Good Manufacturing Practice of Medicinal Products for Hu man and Veterinary Use of the European Union, each of the foregoing as amended from time to time