definiens: means an Active Compound that during or after the Program Term ( i ) has a scientific data package that has been evaluated by MERCK or one of its Affiliates or sublicensees and, at MERCK 's or, if applicable, one its Affiliates ' or sublicensees ', sole discretion ( but consistent with the scientific requirements that MERCK or one of its Affiliates or sublicensees generally applies to other of their internal discovery programs ), approved by the MERCK Safety Assessment Review Committee ( or its successor or equivalent ) to move the Active Compound to formal safety assessment studies ( or its successor or equivalent ) by the Safety Assessment Department ( or its successor or equivalent ) of MERCK or one of its Affiliates or sublicensees ; or ( ii ) otherwise has been approved by MERCK or one of its Affiliates or sublicenses for clinical trials or commercialization and been the subject of an IND