Dossier

Dossier. Shall mean all of the information owned by CLARUS concerning the Finished Product, including without limitation, all test methods, specifications, processes, formulae and other technical knowledge required to obtain Marketing Authorization as well as the results of all pilot or pivotal bioequivalence studies performed with respect to the Finished Product. "Dossier" specifically excludes, without limitation, any portion of the DMF for the API.