definiens: shall mean the fully packaged Product with all nec essary product information leaflets, i.e. SPC in the saleable form as approved by the relevant regulatory authority in the Territ ory ( N ) means all inventories of Components and work - in - pr ocess produced or held by APO in connection with the Manufacture of the Product in a ccordance with the Specifications, but, for greater clarity, does not include the API ; ( O ) shall mean the information and know - how necessary for the Manufacturing of the Product to the exclusion, however, of the manufacturing know -how for the API ; ( P ) or shall mean the converting of API supplied by GILEA D or its appointee into Product by APO at the Facility, incl uding the required analyses and testing of API and such Products, and the packaging and dispatch labeling o f such Product for shipment to GILEAD or its appointee, to the exclusion of the manufacture of A PI by APO