Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 1 of 4 PageID# 34107
`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 1 of 4 PagelD# 34107
`
`EXHIBIT 8
`EXHIBIT 8
`
`

`

`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 2 of 4 PagelD# 3hihy028
`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 2 of 4 PageID# 34108
`
`Section H. Scientific Studies and Analyses
`RAI Services Company
`Vuse Alto PMTAs
`
`TA ble Gf COATES secccscesasnncesscaazcacecccecxcaaaavesnnsesecsaacexaacceamsnance su nnnnncsaassacecccennenaaanewnneeusea7 nee see eecuansaumannnennessuneeennee 1
`Tab MO Ta Bless: ccccccccvensvavoossnssscneecnunwensyyynwneeceevauaan cevvueeneucecesessiiesnueasaueebeueleysyuNSNENNNNREEAALLREerrdieeeeRERaNeNNEEEERNNE 4
`
`Table of Contents
`
`Table of Figures.......ccsssssesssccesesscccseeeeesenueeensuueeeseeuseeeeeeees seseeeusaaaeeessaeeeeeeuaaensegaeeeeeeqneseseeeacseesuaeuuesennceeseeeagensees 10
`Table Of Ab breviat Onsccsssssesiccsccscecccessaaaaiaaccccessaassavavevvcacaaseavensanaaiiiiaseccsces aaaaaancncnncasaaaeeeeeeeecaasaaaannnnaiiiiTiabeceees 12
`Hi
`SatentifieStadies cred Analyses siiticsessssssiereenternttieecasss sensetitioniieesarsieennnern tieteeenccs rand is 15
`H.1
`Design and Manufacturing...........:::00s:::ssssssssesssseesannnesenancecaceeessanceneannanenaceeeseseneeeesesseeeenensneeseeseesnanseses 15
`H.1.1
`Components, Ingredients, and ACCitives.........00.cccccseceeeeesseeeeeeeeeeeessssseeeaeeeneesecanenateeeeesneseesoaeesssoes 15
`H.1.1.1
`Finished Product—Aerosolizing Apparatus With E-Liquid.....ccccccccccccceessscccssssceesensssseseseeeeescaseees 15
`H.1.1.2
`Power Unit Comporserits tid Design... nn ncn nanncinansencomnncnsseani enyeesiaanmnonnenicencee tates 17
`H.1.1.3
`CartridgeComponents and DeSign.........cccccccsseceeccssssseecosseeeeecseeseescceeeaeeanansneecueneesssssasseseeeeeeeees28
`H.1.1.4
`Electrical Connections and Mechanical Interface ..0.......0...cccccccccccceeesesesssseeseeseseesesssseseeeseeeeeees 39
`H.1.1.5
`Product Design Failure Mode and Effects Analysis ............:::00:::::sssssceesssseesansensananceeecesaneeeeeneaes 40
`H,1.1.6
`‘ComparisonWith Other ENDSClosed E-Cigarettes.......cccesssssssseersesssssssseesseeseseecseessesensensseanee.40
`H.1.1.7
`Ea Liguiel pred lenteiiiisse ccccccssvsssasenenesectedtvnnecessasssscunrreatidininnneesssisseennnrenietniieeeeanvaeeny AL
`H.1.1.8
`Packaging .........ccccceeeseeeeeneenneeenseesseeeaeneeeenangensnaneasnaseneeen ceaaaneaaseesesaaeeesssansnaaseaeeesmrrrensnerenenernennd60
`H.1.2
`Principles of OneratiOn ssssssissssesscccivancemamananmmaccnccnmnmmeninnnnenemmmmannesennne61
`H.1.2.1
`Connecting the Com PON ets vescscccccdicierieteecssssssvaeena ttimadinnennssssaaereeennthiaaemeasieereeernlal61
`H.1.2.2
`Operation of the Product...........cccceseeeeSEER EE REESE RIERA ERO ELK EERE RERERERCE AREP UE RRREEENEEEERERNREGE61
`H.1.2.3
`LED NeeothiS DUTPWSO sccccccccccccesnereremmmmnnecceccccceseimniensmnnnmmemnneenT61
`H.1.2.4
`Chargingwot the Power Wi bicsssccscccennniatiiienecccsssssssaseaiadiornnisssasrseennntbiaaen mea scueren ll62
`H.1.2.5
`Features That Mitigate a Consumer's Ability to Change the ProductCharacteristics............... 62
`H.1.2.6
`Features That Prevent Use of Vuse Alto Power Units and Cartridges WithOther
`PR CES tei ssscannnnnnnininiesivevesssseonrereeeennererenenaaswennnannnnnininininnsessssssssarneenenerenmmrrerenannennel62
`PlannedPost-Sale Activation Technology: Prevention of Youth Access..........<n eEaHEmernmerreaREanieueEs 63
`Overview of the Two-Step PSA Process......sccsssessessIea 63
`PSA Technology Hardware and Software Additions ..........ccccccsesseenssersnsenesnseeseeeeseneeenssseenenes 64
`PSA Feasibility and Optimization Evaluations ...........cccccccccsesseseesseeeesneenenseeneescnr neerrememenenenecea: 65
`Summaryofthe PSA TechnOlony ssiisicccccecssissrasssassinnnnnnnnaanasinanimacecssenemnnnnanaes 66
`Manu faCtu lB ices ss nnnnsnncaaiaia ascii innit innainoiiii lassi TREC! 67
`Managerial Oversight .......:10c:ccssssscessseeceessssenneenaceeseneeenasseeueeseeeuneeausessuaseauesauecausennnaasesscsensensnas67
`Emiployee TrainNE ss iicssinnssssssinnimaemnirennnnnmaim TMERRER MIR68
`Supplier Qualification and Momitoring.........c.ccccccseceesesssssseseesseeseesesecssccceseeeeesesneeeauseeeseeensenasessOO
`Handling of Non-Conforming Products and Processes, Corrective Action Preventive
`Action, arid Combat Wtseccccsscscsscsncccenccneerssinmanasasnsnven smemaarnnemecennmamaMeNI70
`Manufacturing Overview ..........ccccccccesssssessssneeesssseeseeesseneeeuseesueeaneeeseesueeeseeaueeaueevvasaeeeseeeeeaeeeess71
`Manufacturing Processes and Testing Procedures .........s0ssssccsssssscsscsssseeeccsseeensenuseessaeeeneesaeenees 72
`Properties..........+=aossicles essenceseinsecaos circa 84
`Aerosol CONStitUGItS ......ccccccssssesceeeeeeseeeeeceeeeeneseeeeesssessacessesseeeeaeenseseeeeeeenanenaeesaeeeseeeeeesseeeseennnne eG
`Aerosol Constituent Studies .........cccc:cccccssseeesssssenececceececcccosseeeeennneesensueeeacoasesceaseeeesessecsenenesenees85
`Rae Te vec pegesiseriscccacerernsaassasamcenemeennn smeeeerrenaTIeE!88
`BRLEGS resectetmemeh poo eeeantNomemenanamnememmmenl 91
`Published Studies in the Literature ..........::sssccsssssscecccceeceecceeeeensaeeneneceeennceeccesesceseeneneessseueeneces 102
`CONCIISONS esciciicnicimnannasisriaRnsRECR A ERERaTTTeRRaNMNRINS 102
`E-Liquid Properties .........ccccccssssseceeceeseeceeeeeeeeeeceessseseessssnsaaaeesceeeeesaseesesseseeeceeeee se eeeeeesssssseseeseseneeees 104
`
`H.1.4.5
`H.1.4.6
`H.2
`H.2.1
`H.2.1.1
`H.2.1.2
`H.2.1.3
`H.2.1.4
`H.2.1.5
`H.2.2
`
`H.1.3
`H.1.3.1
`H.1.3.2
`H.1.3.3
`H.1.3.4
`H.1.4
`H.1.4.1
`H.1.4.2
`H.1.4.3
`H.1.4.4
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`Most Confidential
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`Page 1 of 366
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`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`RJREDVA_001450878
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`PX-028
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`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 3 of 4 PageID# 34109
`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 3 of 4 PagelD# 34109
`
`Section H. Scientific Studies and Analyses
`RAI Services Company
`Vuse Alto PMTAs
`
`Table H-6:
`
`Vuse Alto Cartridge ComponentDetails
`
`Location and Description
`
`Supplemental view
`
`inhibit leakage of airflow or condensate around the mouthpiece.
`
`The “Cartomizer Holder Tap” component is a mouthpiece made from black
`polycarbonate that is mechanically attached to the Cartomizer Tube
`component by snap joints. Aerosol is drawn through the hole at the center.
`Silicone 4:
`
`The “Silicone 4” componentis a seal made from silicone. This component is
`compressed between the Cartomizer Holder Tap and the Cartomizer Tube to
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`Most Confidential
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`Page 32 of 366
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`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`RJREDVA_001450909
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`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 4 of 4 PageID# 34110
`Case 1:20-cv-00393-LMB-TCB Document 1376-8 Filed 06/29/22 Page 4 of 4 PagelD# 34110
`
`Section H. Scientific Studies and Analyses
`RAI Services Company
`Vuse Alto PMTAs
`
`Yuan, J. M., Koh, W. P., Murphy, S. E., Fan, Y., Wang, R., Carmella, S. G., et af. (2009). Urinary levels of tobacco-
`specific nitrosamine metabolites in relation to lung cancer development in two prospective cohorts of
`cigarette smokers. Cancer Res, 69(7), 2990-2995.
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`Most Confidential
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`Page 366 of 366
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`CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`RJREDVA_001451243
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