definiens: means ( i ) any decision ruling, directive, instruct ions, position, guidance or other action, whether in writing or otherwise of a Regula tory Agency, IRB or ethics committee, any change in a Regulatory Agency, IRB or ethics committee approval processes or regulatory requirements ( including Cl inical Study requirements ) from those in effect on the Eff ective Date, or any inaction on the part of a Regul atory Agency, IRB or ethics committee, in each case that materially affects the requirements for, or the tim eline of, the Development and Regulatory Approval of the Licensed Product(s ) in the U.S. or other countries in which Regulatory Approval is being, or is required to be, sought, ( ii ) a Licensed Product Manufacturing Fail ure, or ( iii ) a determination by [COMPANY], in the exercise of it s reasonable discretion, that data or other informa tion obtained during the course of, or as a result of, any Clinic al Study for the Compound or Licensed Product(s ) wi ll have a material adverse affect on the safety or efficacy o f the Licensed Product(s ) or require that additiona l Development activities be conducted ( exceeding that provided in the then current Development Plan ) for the Development and Regulatory Approval of the Licensed Product(s )