definiens: shall mean the fully packaged Bulk Product with all necessary product information leaflets, i.e. SPC in the saleable form as approved by the relevant regulatory authority in the Territ ory ( L ) shall mean the information and know - how necessary for the Manufacturing of the Bulk Product to the exclusion, however, of the manufactu ring know - how for the API ; ( M ) means all inventories of Components and work - in - p rocess produced or held by APO in connection with the Manufacture of the Bulk Product in accordance with the Specifications, but, for gr eater clarity, does not include the API ; ( N ) or shall mean the converting of API supplied by GILEAD or its appointee into Bulk Product by APO at the Manufactu ring Location, including the required analyses and testing of API and such Bulk Products, and the bulk packing and dispatch labelling of such Bulk Produc t for shipment to GILEAD or its appointee, to the exclusi on of the manufacture of API by APO ; 3 ( O ) shall mean the Manufacturing location for the Bul k Product of APO at [ * ] ; ( P ) means the authorization to market Finished Produc t in a jurisdiction issued by the appropriate Regulatory Agency in such jurisdict ion