definiens: shall mean activities associated with development of Active Compounds as DevelopmentCandidates for sale as Drug Products in the Cardiac Field and in the Territory, including but not limited to : ( a ) formulation ofActive Compounds as [ .. * * .. ] CONFIDENTIAL TREATMENT REQUESTED5 Development Candidates for use in preparation for preclinical studies ; ( b ) preclinical animal studies performed in accordancewith GLP ( or the applicable equivalent ) in preparation for the filing of an IND ( or the applicable equivalent ) ; ( c ) formulationand manufacture of Active Compounds as Development Candidates for preclinical and clinical studies ; ( d ) planning, implementation, evaluation and administration of human clinical trials ; ( e ) manufacturing process development and scale - upfor the manufacture of bulk Active Compound and Drug Product ; ( f ) preparation and submission of applications for regulatoryapproval ; and ( g ) post - market surveillance of approved drug indications, as required or agreed as part of a marketing approvalby any governmental regulatory authority