definiens: means any patents, patent applications, certificates of invention, or applications forcertificates of invention and any supplemental protection certificates, together with any extensions, registrations, confirmations, reissues, substitutions, divisions, continuations or continuations - in - part, reexaminations or renewalsthereof that claim or cover the Compound, Licensed Product or any Improvement, including methods of development, manufacture, formulation, preparation, presentation, means of delivery or administration, dosage, packaging, sale oruse thereof 9 * * * = Portions of this exhibit have been omitted pursuant to a request for confidential treatment . Anunredacted version of this exhibit has been filed separately with the Commission.1.47 means a Clinical Study that is intended to initially evaluate the safety orpharmacological effect of a Licensed Product in the Field in subjects or that would otherwise satisfy requirements of21 CFR 312.2(a ), or its foreign equivalent