definiens: means 1300,:1 Manufacturing Practices and General LB Products Standards as promlJlgated under the US Federal Food Drug and Cosmetic Act at 21 CFR ( Chapters 210, 211, 600 and 610 ) and the Guide to Good Manufa,;turing Practices for Medicinal Products as promulgated under Europeafl Directive 91/356 / EEC . LB 's operational quality standards are aefintld in internal GMP policy documents . Additional product - specific development documentation and validation work may be required to SUPpl)rt rE ~ gulatory applications and to conduct clinical trials or market a product oe,11.00 / JAS / dorIb0694 .Delivery Date " shall mean the date determined in accordance with Clause 5 below upon which, the later of either the date : ( i ) a given Bat.::h of Product to be produced pursuant to Stage 2 of the Services . or ( ii ) the Cenlficare of Analysis ( or lot review documentation in the case of Prod~ .lct being assessed against a draft Specification ) relating thereto ; is to be ready tor d'Hivery to [COMPANY] ex works LS 's premises ( Incoterms 2000 )