definiens: or . Develop or Development means, with respect to the Product : ( a ) Characterization of the Product ; ( b ) all activities associated with the filing of an ANDA for the Produ ct as provided for in this Agreement, including, without limitation, preclinic al and clinical drug - development activities, such as, but not limit ed to, toxicology, preclinical and clinical studies ; ( c ) formulation, process development and commercial scale - up -4- EXECUTION COPY ( to the commercial batch size agreed upon in the An nual Collaboration Plans which shall be a batch size that is commercially re asonable given expected production ) activities ( including test - method devel opment ) ; ( d ) development of quality assurance / quality control procedures ; ( e ) w ith respect to the drug substance for the Product, commercial scale validat ion and commercial scale stability studies ; ( f ) with respect to the drug pro duct form of the Product, commercial scale process validation, commercial sca le stability studies, packaging, tooling, package design, packaging valid ation and labeling preparation ; ( g ) statistical analysis ; ( h ) regulato ry affairs ( including legal activities with respect thereto ) ; and ( i ) Product a pproval and registration activities . or does not inc lude Commercialization or Legal Activities