definiens: or means a submission to any relevant regulatory aut hority that provides detailed information about facilities, processes or methods used in the manufacture, processing, packa ging and storing of a drug or excipient, among others, in or der to obtain regulatory approval for the productio n for that drug ; means the date set out on page one of this Agreem ent ; means the Australian Pesticides and Veterinary Me dicines Authority and any successor thereto ; means the fees specified in Exhibit C, as may be amended by the parties in accordance with this Agreement ; Requirements ” means : the current Good Manufacturi ng Practices standards required under ICH Q7 guideline ; means, in relation to any Intellectual Property, any and all versions, adaptations, modifications, improvements, enhancements, changes, revisions, translations and derivative works ( whet her complete or incomplete ), of, to, in or based upon s uch Intellectual Property ; 2 CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CER TAIN PORTIONS OF THIS DOCUMENT . EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK * * *, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION