definiens: shall mean activities associated withdevelopment of Active Compounds as Development Candidates for sale as DrugProducts in the Territory, including but not limited to : ( a ) formulation ofActive Compounds as Development Candidates for use in preparation forpreclinical studies ; ( b ) preclinical animal studies performed in accordance withGLP ( or the applicable equivalent ) in preparation for the filing of an IND ( orthe applicable equivalent ) ; ( c ) formulation and manufacture of Active Compoundsas Development Candidates for preclinical and clinical studies ; ( d ) planning, implementation, evaluation and administration of human clinical trials ; ( e)manufacturing process development and scale - up for the manufacture of bulkActive Compound and Drug Product ; ( f ) preparation and submission of applicationsfor regulatory approval ; and ( g ) post - market surveillance of approved drugindications, as required or agreed as part of a marketing approval by anygovernmental regulatory authority