definiens: shall mean activi ties associated with development of a Drug Product Candidate which are c onducted by or at the direction of NOVARTIS after the Development Electio n has been exercised with respect to that Drug Product Candidate, including b ut not limited to ( a ) manufacture and formulation of Drug Product Candida tes for use in pre - clinical, non - clinical and clinical studies ; ( b ) pre - clinical and non - clinical animal studies performed in accordance with GLP ( or the ap plicable equivalent ) ; ( c ) planning, implementation, evaluation and administra tion of human clinical trials ; ( d ) manufacturing process development, scal e - up and commercial manufacture of Drug Product ; ( e ) preparation and su bmission of License, Development and Commercialization Agreem ent-- Confidential-- Page 2 CON FIDENTIAL TREATMENT REQUESTED applications for Regulatory Approval ; and ( f ) post- market surveillance of approved drug indications, as required or agreed as part of a marketing approval by any governmental regulatory authority