“GLP Toxicology Study” means a toxicology study conducted in accordance with the then current FDA regulations and guidelines for “Good Laboratory Practice,” as promulgated by the FDA under 21 CFR Part 58, as amended from time to time, or any foreign equivalents thereto in the country in which laboratory studies are conducted.

“GLP ToxicologySafety Study” means a toxicology study conductedstudies that meet the requirements set forth in accordance with the then current FDA regulations and guidelines for “Good Laboratory Practice,” as promulgated by the FDA under 21 CFR Part 58, as amended from time58 pertaining to time,Good Laboratory Practices for use or any foreign equivalents theretointended for use in an investigational new drug application, but excluding toxicology studies performed in the country in which laboratory studies are conducted.course of evaluating compounds prior to selection of a development candidate.