definiens: means a Product supplied in ﬁnished form, ready for distribution in an applicable country in compliancewith all Applicable Law in such country at the relevant time, including all applicable primary, secondary, or tertiarypackaging and labeling of such Product ( in its commercial packaging presentation ) for sale or use in the applicablecountry, including : ( a ) the Regulatory Authority - approved full prescribing information for such Product in the applicablecountry ; ( b ) the Regulatory Authority - approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Product in such country ; and ( c ) insertion of materials such aspatient inserts, patient medication guides, and professional inserts, and any other written, printed, or graphic materialsaccompanying such Product, including any additional information and materials necessary to comply with serializationrequirements in the applicable country, and any brand security or anti - counterfeiting measures included in the packagingelements for such Product considered to be part of the finished packaged Product, and all testing and release thereof