definiens: means[data package, termed a Preclinical Lead Profile, that describes a particular Lead Compound and is presented to the [COMPANY] Pharmaceutical Group Operating Committee ( ) in accordance with its procedures, approval of which is necessary for such Lead Compound to be put on a PLP development track . The data package will typically contain, without limitation, ( i ) synthesis and physico - chemical properties'ofthe compound, ( ii ) in vitro activity, ( ii ) in vivo activity in appropr.iate animal models, ( iv ) metabolism, absorption and pharmacokinetics data, ( v ) limited toxicology data, ( vi ) summary of competition, ( vii ) patent status, and ( viii ) business plans for the product . The candidate Lead Compound covered by the PLP becomes an when the approval by the BMSPGOC of the PLP candidate Lead Compound has been documented in the BMSPGOC meeting minu ~ es.l means any final form or dosage of any drug product that incorporates a Lead Compound and that will be sold or used witliin the Fiela .. -~- ..