definiens: means the applicable then - current good manufactur ing practice standards relating for fine chemicals, intermediates, bulk products, or finishe d pharmaceutical, biological, or diagnostic product s, as are required by applicable Regulatory Authorities or Ap plicable Law in the relevant jurisdiction, includin g, as applicable : ( a ) all applicable requirements detaile d in the FDA ’s current Good Manufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211 ; ( b ) all applicable requirements detailed in the EMA ’s “ The Rules Governing Medicinal Products in the European Commun ity, Volume IV, Good Manufacturing Practice for Medicinal Products ; ” and ( c ) all Applicable Law pro mulgated by any Governmental Authority having jurisdiction over the manufacture of the applicable molecule, agent, compound, or pharmaceutical, biol ogical, or diagnostic product, as applicable