definiens: means the list of the responsibilities of the parties relating to cGMP activities and the standards to which Product is to be Manufactured as agreed by the parties ; means the person so designat ~ din .accordance with either EEC directive 75/319 or Article 5 oflhe Swiss AMBV ( a ) ; means the raw materials and other consumable items"- ' -­(including without limitation filters, membranes and packaging materials ) which are required by [COMPANY] to conduct the Manufacture of Product ; means a document authorised by a Qualified Person stating and confirming that the Raw Materials to which the document refers have met all cGMP criteria and meet the Specification, in accordance with the terms of the Quality Agreement ; 1.1.55 means any product licence, marketing authorisation or clinical trials certificate issued by the relevant Regulatory Authority and in terms permitting, as appropriate, the importation, distribution, sale, marketing or use of Product ; 1.1.56 means Swissmedic, the FDA, the EMEA or any equivalent governmental regulatory body ; 1.1.57 or means the mechanism by which [COMPANY] certifies that Product was Manufactured in accordance with the cGMP Batch Records and with this Agreement including cGMP and that Product conforms to the relevant Specification based on the results of all Product tests listed in the Quality Agreement . Release is demonstrated by issue of a Certificate of Analysis ; 1.1.58 means operational weeks ( either consecutively or in sub - units, as agreed by the parties ) in the BPMSS and/or BPMLS in the total amount of CHF 30,000,000 ( thirty million Swiss Francs ) calculated by reference to the Introductory Rate ; 1.1.59 means the activities to be performed by [COMPANY] under this Agreement ; 1.1.60 means the analytical tests, methods and acceptance criteria for each Product, which identifies the criteria to be met during the various phases of Production before the relevant Product can be Released by [COMPANY] ;, 6 ... " .. .DeltaView comparison ofiManageDeskSite : IINYDMSOIINYDOCS/115899811 and iManageDeskSite:/INYDMSOIINYDOCSI1158998/2 . Performed on 6/2112004