definiens: means all Laws and guidelines applicable to Manuf acture of the Licensed Compound or Licensed Product, including ( a ) the FD&C Act ( 21 U. S.C. 321 et seq . ) ; ( b ) relevant United States regul ations in Title 21 of the United States Code of Federal Regul ations ( including Parts 11, 210, and 211 ) ; ( c ) Euro pean Community Directives 2001/83 / EC and 2003/94 / EC ; ( d ) the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, as set out in Volume 4 of the European Commission ’s R ules governing medicinal products in the EU ; ( e ) those s tandards required by the MHLW ; ( f ) ICH, Q7 Good Manufacturing Practice Guidance for Active Pharmace utical Ingredients ; ( g ) similar standards and Laws to those in ( a ) through ( f ), as are in effect at the time of Manufacture of the Licensed Compound and/or Licens ed Product ; and ( h ) all additional Regulatory Authorit y documents or regulations that replace, amend, mod ify, supplant or complement any of the foregoing