definiens: means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk pro ducts or finished pharmaceutical products, includin g ( a ) the principles detailed in the U.S. Current Good Manufa cturing Practices, 21 C.F.R. Parts 210 and 211, as may be amended from time to time, ( b ) Laws promulgated by any Gove rnmental Authority having jurisdiction over the manufacture of the Drug Product, including but not limited to the Clinical Trials Di rective, the Community Code, the Commission Directive 2003/94 / EC laying down the principles and guidelines of good manufact uring practice in respect of medicinal products for human use and investigational medicinal products for human use ( t he ) and the related national implementing l aws and regulations of the European Union ( ) Member States, as may be amended from time to time, and ( c ) guidance documents promulgated by any Governmenta l Authority having jurisdiction over the manufacture of the Drug Product, including but not limited to V olume 4 of 4 [ * * * ] INDICATES MATERIAL THAT WAS OMITTED AND FOR W HICH CONFIDENTIAL TREATMENT WAS REQUESTED . ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUAN T TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 19 34, AS AMENDED