definiens: ( as hereinafter defined ) produced by a Third Party manufacturer ( ) and its UK located affiliate GILEAD Sciences Int ernational Ltd. Cambridge is the holder of the Marketing Appro val ( Approval No . : [ * ] ) pursuant to EU regulation 2309/93 / EEC ( as amended ) or any implementation of i t under the laws of any relevant EU member state wh ere GILEAD markets the Finished Product ; WHEREAS, APO is the holder of the Manufacturing aut horization pursuant to Directive 75/319 / EEC ( as amended ) and any implementation of it under the law s of Germany for the manufacturing of products at i ts site at [ * ] and it is interested in Manufacturing the Bulk Pro duct ( as hereinafter defined ) for GILEAD ; NOW, THEREFORE, the Parties thereby agree as follow s : DEFINITIONS ( A ) of a Party shall mean a corporation or other corp orate entity that owns, is owned by or is under common direct or indirect ownership with such Party, where, and refer to ownership of over fifty percent ( 50 % ) of the voting shares or other voting interest of such entity or the ability to control or direct management of such ent ity