definiens: means current Good Manufacturing Practices as promulgated in EU Commission Directive 2003/94 / EC ( EU GMP Guidelines ) and 21 CFR 211 ( US / F DA cGMP for Finished Pharmaceuticals ), 610 ( US / FDA General Biological Products standards ), EU Commission Directive 2001/20 / EC ( Clinical Trials ), EU Commission Directive 2004/23/ EC ( Quality and safety of human tissue and cells ), EU Regulation EC 1394/2007 ( Advanced Therapy Medici nal Products ( ATMP ) ), EU Directive 2001/83 / EC ( Medicinal Products for Human Use ), and national implemen tation of the foregoing, and applicable International Conference on Harmonisatio n guidelines as well as any applicable regulatory guidelines issued by Government Competent Authoriti es in particular relevant guidance on Good Manufacturing Practices containe d in Volume 4 of the Rules Governing Medicinal Prod ucts in the European Union and the national implementations of these rules . For the avoidance of doubt, [COMPANY] 's operational quality standards are defi ned in internal GMP documents which shall always be consistent and compliant with and adequately refl ect current international applicable cGMP guidelines and allow cGMP manufacturing of investig ational biopharmaceutical products and products for cellular therapies ( ATMP ) ; 1.10 means all data, information or material in whatev er form that has or could have commercial value or other utility in the busin ess or prospective business of a Party 's company or its subsidiaries or Affiliates, whether or not such information is identifie d as Confidential Information, and any and all copies and derivations thereof and improvements thereon