definiens: means the applicable then - current good manufacturing practice standards relatingfor fine chemicals, intermediates, bulk products, or finished pharmaceutical, biological, or diagnosticproducts, as are required by applicable Regulatory Authorities or Applicable Law in the relevantjurisdiction, including, as applicable : ( a ) all applicable requirements detailed in the FDA ’s current GoodManufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211 ; ( b ) all applicable requirementsdetailed in the EMA ’s “ The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products ; ” and ( c ) all Applicable Law promulgated by anyGovernmental Authority having jurisdiction over the manufacture of the applicable, antibody or otherBiologic ( or a functional fragment thereof ), molecule, agent, compound, or pharmaceutical, biological, ordiagnostic product, as applicable