First:OnoraboutthedatesspecifiedintheInformation.thedefendantandatleastoneotherpersonenteredintoanunlawfulagreementtoIntroduceandDeliverforIntroductionintoInterstateCommerceanAdulteratedandMisbrandedDeviceinviolationof21U.S.C.§331(a);theelementsofsaidoffensebeing:(a)thatthedefendantintroducedanddeliveredforintroductionintointerstatecommerceanydevice,thatissilicone,asdefinedin21U.S.C.
§
321(h)(3);
(b)
thatsaiddevicewasmisbranded,asdefinedin21U.S.C.
§§
352(b)and(f),inthatthelabelinglackednameofmanufacturer.packerordistributorandadequatedirectionsforuse,andadulterated.asdefinedin351(f)(1),inthatthedevicelackedFoodandDrugAdministration('IFDA")approval;and(c)thatthedefendantcommittedsuchoffensewiththeintenttodefraudormislead;Second:Thatthedefendantknewtheunlawfulpurposeoftheagreementandjoinedinitwillfully,thatis,withtheintenttofurthertheunlawfulpurpose;andThird:Thatoneoftheconspiratorsduringtheexistenceoftheconspiracyknowinglycommittedatleastoneoftheovertacts,thatisinjectingsiliconeintohumanbuttocksforafee,inordertoaccomplishsomeobjectorpurposeoftheconspiracy.Penalties3.ThemaximumsentenceprovidedbystatutefortheoffensetowhichtheDefendantispleadingguiltyisasfollows:imprisonmentfornotmorethan5yearsorafineofnotmorethan$250,000orboth.Inaddition,theDefendantmustpay$100asaspecialassessmentpursuantto18U.S.C.
§
3013,whichwillbedueandshouldbepaidatorbeforethetimeofsentencing.ThisCourtmayalsoorderhertomakerestitutionpursuantto18U.S.C.
§
§
3663,3663A,and3664.Ifafineorrestitutionisimposed,itshallbepayableimmediately,unless,pursuantto18U.S.C.
§
3572(d),theCourtordersotherwise.TheDefendantunderstandsthatifsheservesatermofimprisonment,isreleasedonsupervisedrelease,andthenviolatestheconditionsofhersupervisedrelease,hersupervisedreleasecouldberevoked-evenonthelastdayoftheterm-andtheDefendantcouldbereturnedtocustodytoserveanotherperiodofincarcerationandanewtermofsupervisedrelease.TheDefendantunderstandsthattheBureauofPrisonshassolediscretion
in
designatingtheinstitutionatwhichtheDefendant
will
serveanytermofimprisonmentimposed.WaiverofRjghts4.TheDefendantunderstandsthatbyenteringintothisagreement,shesurrenderscertainrightsasoutlinedbelow:a.IftheDefendanthadpersistedinherpleaofnotguilty,shewouldhavehadtherighttoaspeedyjury
trial
withthecloseassistanceofcompetentcounsel.That
trial
couldbeconductedbyajudge,withoutajury,iftheDefendant,thisOffice,andtheCourtall
2