definiens: or [ [ means the stage of preclinical development of a compound, under [COMPANY] standard procedures, at which such compound is fonnally selected to enter a program of preclinical research and investigation intended to generate all the data and infonnation needed to prepare and submit an IND covering such compound . Under [COMPANY] standard procedures, a lead compound becomes a, when a data package that describes that particular lead compound is presented to the [COMPANY] Pharmaceutical Research Institute Drug Discovery Management Committee ( the ) in accordance with its procedures, and receives approval to be put on a development track with a goal of making an IND filing for such lead .compound . The data package will typically contain, without limitation, ( i ) synthesis and physico - chemical properties of the compound, ( ii ) in vitro activity, ( ii ) in vivo activity in appropriate 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 is deemed approved only when approval by the DDMC of the lead compound as a PLP candidate has been documented in the DDMC meeting minutes . If [COMPANY] changes it procedures in any material respect, this definition shall apply to the closest fonn of approval within [COMPANY] that approximates the foregoing ]