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This agreement and the obligations of the Parties must meet the requirements of good manufacturing practice (GMP). This means that the statutory regulations in place and also the AMG (German Pharmaceutical Products Act) and AMWHV (Pharmaceutical Products and Active Ingredients Manufacturing Regulation) are to be observed as well as the requirements of GMP-suitable manufacturing and testing as per EU Directive 2003/94/EC as well as the EU GMP guidelines based on this directive and the relevant ICH guidelines and all applicable rules and statutory provisions.