definiens: or means to engage in r esearch and development activities intended to research, discover or develop Licensed Compounds an d / or to support INDs, BLAs or other Regulatory Approvals for Licensed Products, including, without limitation, ( i ) development of the applicable acti ve drug substance(s ), ( ii ) toxicology, pre - clinical and cli nical drug development activities, ( iii ) clinical t rials ( except for Phase IV Studies ), ( iv ) assay / test method developme nt, validation and stability testing, ( v ) formulati on development, ( vi ) manufacture of pre - clinical, clin ical and commercial supplies, and manufacturing pro cess development, scale - up and validation, ( vii ) quality assurance / quality control, statistical analysis, a nd regulatory affairs ( including without limitation the preparati on, submission and maintenance of all INDs and BLAs for the Licensed Products ), and ( viii ) to have any of the a ctivities described in ( i)-(vii ) performed