definiens: shalllmeananyandallnational, international, federal, state, provincial orlocallegislation, gUidelines, common law, regulations andgovernment policiesrelatingtothemanufacture, use, anddistribution oftheProduct;1.4 meansaproduction batchofanapproved quantity ofunitsofProduct, orasotherwise agreedbytheParties;1.5 ofaPartyshallmeananyInformation disclosed byonePartytoanother, whether Inwriting, orally, inelectronic formorintheformofsamplesormaterials, ( I)whichisdesignated confidential atthetimeofdisclosure, whether orallyorInwriting, or(lI)whichshoUldbeconsidered confidential byitsnatureandthecircumstances surrqundlng Itsdisclosure, including withoutlimitation information concerning thatParty'sbusiness, technology, processes, products, proposed newproducts ortechnology, productcosts, productprices, finances, marketing plans, business opportunities, research, development orknow­howwhichisconfidential andproprietary tothatPartyandIsnotgenerally knowntothepublic;1.6meanseachsuccessive twelvecalendar monthperiodduringthetermofthisAgreement . ThefirstContract YearshallbeginontheEffectiveDateofthisAgreement andendonDecember 31stofthatyear . ThelastContractYearshallendonthedaythisAgreement Isterminated;1.7 meansthemostcurrentpractices setoutinthegUidelines pUblished asgoodmanufacturing practicesrelatedtoandasapplicable topharmaceutical excipients underApplicable Lawsby(I)theFood&DrugAdministration ofUSAand(Ii)therelevant European nationalauthorities, andassameareineffectfromtimetotimeduringtheTermofthisAgreement;1.8 meanstheeffective physical handing overoftheProducttoLabopharm atLabopharm 's facilities, .Labopharm 's manufacturing site, orsuchotherlocationasdesignated byLabopharm inaccordance withth.eprovision ofart