“GLP Safety Study” means toxicology studies that meet the requirements set forth in 21 CFR Part 58 pertaining to Good Laboratory Practices for use or intended for use in an investigational new drug application, but excluding toxicology studies performed in the course of evaluating compounds prior to selection of a development candidate.

“GLP SafetyToxicology Study” means a toxicology studies that meetstudy conducted in accordance with the requirements set forth inthen current FDA regulations and guidelines for “Good Laboratory Practice,” as promulgated by the FDA under 21 CFR Part 58 pertaining58, as amended from time to Good Laboratory Practices for usetime, or intended for use in an investigational new drug application, but excluding toxicology studies performedany foreign equivalents thereto in the course of evaluating compounds prior to selection of a development candidate.country in which laboratory studies are conducted.