definiens: shall mean all know - how owned or controlled by MERCK KGAA and its AFFILIATES relating to the production of VILAZODONE API ( as defined in Section 3.1 ) and VILAZODONE drug products laid down in a ) a development report including identification of critical steps and a description of polymorphism including conditions for formation and transformation and stability thereof ( if a report is not available, all available information to enable preparation of a report ) ; and b ) manufacturing instructions of the most recent manufacturing campaign including amount and ratio of all materials, equipment, operating parameters ( e.g., time, temperature, pressure ) expected yields for all steps starting from commercially available starting materials, in - process controls including analytical methods, specifications for intermediates, starting materials, solvents, reagents, and ancillary materials if defined ; and c ) batch analysis results for batches used in toxicity and clinical studies, including impurity profile, date of manufacture, manufacturing process information and batch size . VILAZODONE MANUFACTURING TECHNOLOGY also includes all know - how MERCK KGAA and its AFFILIATES own or control at the time the VILAZODONE MANUFACTURING TECHNOLOGY is transferred to GENAISSANCE related to the production of VILAZODONE tablets, i.e. the development report ( if a report is not available, all available information to enable preparation of a report ), manufacturing instructions including equipment operating parameters ; and in­process controls including analytical methods