definiens: means ( 1 ) any drug - related adverse event or event s in patients who received a Lead Molecule in a clinical trial or any other setting, or any other adverse events specifically relating t o the research, development or manufacture of a Lead Molecule, if s uch adverse event or events would reasonably be exp ected to prevent, or materially delay, the filing with th e FDA of an Investigational New Drug application ( a n ) covering such Lead Molecule, or materially limit th e scope of such IND or any subsequent clinical tria l regarding such Lead Molecule or ( 2 ) any failure to adhere to the requirements under the US Food Drug a nd Cosmetics Act, the regulations and guidance documen ts of the FDA promulgated thereunder or any other applicable Legal Requirement, the equivalent Legal Requirement of the EMA and its Committee for Medici nal Products for Human Use, or the EU member states, or any Governmental Authorization ( including the fail ure to possess or maintain the validity of any permit ), re lating to the investigational use and clinical tria ls of a Lead Molecule or with respect to the making of untrue or fraudulent statements or the disclosure of informa tion, or any failure to adhere to clinical protocols or info rmed consent requirements, in any such case under t his clause ( 2 ), which, individually or in the aggregate, would reasonably be expected to prevent or materi ally delay the filing with the FDA of an IND covering a Lead M olecule, or prevent or materially delay a Lead Mole cule from obtaining Regulatory Approval, or materially l imit the scope of A-4 Table of Contents Regulatory Approval, from the FDA or the European C ommission, to market the Lead Molecule for any indication