definiens: means manufacture in accordance with : ( i ) EC Directive 91/456 / EEC, as may be a mended from time to time ; ( ii)the current principles and guidelines of Good Manufacturing Practice for medicinal products for human use as required by, but not limited to, the applicable sections of the US Federal Food, Drug and Cosmet ic Act, the US Public Health Service Act, the US Code of Federal Regulations, Title 21, Parts 210 ( CURRENT GOOD MANUFACTURING PRACTICE IN 2 < PAGE > MANUFACTURING, PROCESSING, PACKING, OR HOLDI NG OF DRUGS ; GENERAL ) and 211 ( CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS ), and relevant final FDA Guidance and Points to Consider for drugs and/or biotechnology -derived products, as amended from time to time ; or ( iii ) the equivalent current law or regulation in any market