'Roy S. Haber, OSB No. 800501haberc~yb-dyne.comROY S. HAER P.C.570 Ea 40tb AvenueEugene, OR 97405 . ~Telephone: 541.485.6418

. FAX: 541.434.6360DOD B. Marmaduke, OSB No. 53072don.m8uk~nkon.comTONKON TORP LLP .160 Pionee Tower888 SW Fift AvènuePord, OR 972042099Direct Di: 503.802.2003Dí FAX: S03~972.3703

Gilert Paul Carrasc, Calforna Bar Nò. 90838

(Appeang pro ha vice)car~iiamett.edu .. No. 451 .245 Winte 8.trt SESalem, OR 97301Telephone:. 503.370.6432FAX: 503.370.6375

Atoreys for Plaiti

. IN TH UN STATE DlsnuCT COURT

DISTRCT OF OREN

(Medord Division)

THE CHUCH OF TI HOLY LIGHT OFTH QUEEN, .aIa The Santo Daie Clurh,àn Or religious corpraon on its ownbeha and on be of al of its memerJONATH GOLDMA, inviduay an asSpirtu Leer of the "Sanro Daie Churh, II .JACQUELYN PRETIGE. MAY ROW, ~M.D., MI ~EY, ALRABUSS YEAGER and SCOTf FERGUSON.member of th Santo Daie Churh,

Plaitiffs,

Civil No. 08-cv-03095-PA

AMNDED EXPERT WITNSSSTATEMENT OF NICHOLA V.COZZI, Ph.D.

v.

Page i - AMBD EXPBRTWlS STATE OF NICHOLA V. COZZ Ph.D.

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MICHAEL B. MUKAEY, Attorney Geeraof the United State; KA J. IMRGUT,Unite Staes Attorney, Distrct of Oregon;HENRYM. PAULON, Secret of the U.S.Deparent of the Treur,

Defendants.

~y nae is Nicholas V. Cozzi, Ph,D.

.PHACOLOGICAL TOXICOWGICAL, AN DRUG POLICY ISSUESSUROUNING TH SOUT AMERICAN DAIME

. I have ben reues to provide my expe òpinon. on the ,pharnlogy of "Daime", asaénl te. use by th. San Dah Churh. Dae is pre frm th. bark ofBanerils CDi and th leaves of P.shotra Yirid, two plants indigeus to the.A.n reôn of Sout Amenca pàme .is also known' as uayauaca" and ''honcattout~ the Santo Daùe Chur I have aI ben as to provide an asesen of 8IYtoxic effec th may arse frm inesti Daie.. Finy~ I have. be. ased tocomment on drpolicy issu relad to Dai.

I JiJ4 a B.S. degr in Phalogy and Toxicology 1Im th Univesity of Wisiran a Ph. degree in Phaacology, al frm ~,Univerty of Wis.Phlogy is commonly denned as th uned st of the prpeies of chemicasand Jiving orgms and al aspec of their inraons. Toxicology is a subvision bfPhacology th is conce with th advers or to~ic ef of chemicas 'onbiologica systms. My edcaon and exereii in th. discplies is detled in my .cuculum vita. I CUnty hold th P9sitions ofFaçulty Asia and Senor Scientisin th Deen of Phlogy at th Univerit of W'isnsin Schol of Medicine. aw Public Heath Mad WI. J am bo th cour dì an an intor in thMdoa Phlogy cour ta by al se-yea medica stents as well asør stdets in th Molecul an eeular PhacJogy 'prgr at the Univeityof Wisco. i al ~ a reh prgr focus on th p~logicai effec ofvarous pschoactive substce, includin the substce 'pr in Dai. MyIàwledge of the phalogy an toxilogy ofDøime oomes ûom my rea of th.medca and scienc lite my paçlpaon in prfessiona confer, discussionswith collea, an my own reearh over mo~ th twenty-five yea. .

In pron for wrti tls Declaon, I have reiewed numèrous scentfic joumareIe th ex report of Dr. lohn Hape an th rert subtt by Dr. DavidNichols for the ItO Cetr cae" involvi th Uni do.Veget (loin Apei to thSupree CoUr at 337).. I will te to my agent with all of Dr. Nichol'sstents.

Page 2 - AMNDED EXPERT WITS STATE OF NIæOLA V. COZZ. Ph.D.

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Introduction

the ealiest published report in the Wes lite of ayahuas (Daime) use. wewrttn by Rièhår Spruce, an Enish botast and expiorer. . Sprce described the use ofayahua by.seer trbe living in the upper Amazn River region of South AmercaThes acunts date to the i 850's, but it is evident th the sacramenta te ha ben us

. -by nave South Amerca peples frñi mueh ealier times. possbly thousds of yea.Th te ha ben used for both religious and cemonial purse by thes people. Inea Per for exaple, the te is ingested by sba to diaose and tr diSe,whe in Colombiå ànd B~, Daie is emloyed in religious cereonies ti ar rote

. in trba mytology. In . more reent ties, the religious Us of ayahuas ha beorgze under the ausice of the. Santo Da Churh (Who cal it Daie) an theUni1O do Veget (wh.cal it hoas te). Both of these religitlDS ar synerec religions.Tht is, they combin prexist loc beliefs with th Chsti beliefs of Eurpepeple with whom they have int~ed. Th sta of consiouses elicite by. Daie. is said. tò be dely religious an is discusse in other reort. Simlar stes ofcoiouses. oft referr to as "hucingenc", ar produc by varous plånts andsythetC.90mpounds. . . .The Molecular Phalog ofDaig

. Stuès of th plants us to pre Dame revea th th .plats contaphalOgicay acve compunds. One of th plants us to pre Daie.Psytrla Yiidi, cont the indole aJoid N;N-detyltre (DM1). DMT isnot Unqu to Psyhoia viridi bu is. foUn in hundr of plats anun th wod.DMT is a pote psychoacve dr in its synthc form and wheJ injec; however, it is. not :normy active .wh C01;ed by mout in beus it is radl deYed byenes in th gu In order fo .DMT to be oray acve, the enes tht,dey DMTin the gu mus fi be ne Baisteriopsis caai. the ot ma Compnen ofDaime, in ià CQnt the SUce ~t neal th enzes tht would nomiydey DMT. Thus, it is th combination of both PS)hotria vir an Batertopsis. èa togeter tht alows th Daie te to pruce it pschoave effs.

TJ PSch prpees of Dame te ar du to the abilties of the subsce in. thete (DMT and ot compounds) to ac on ce rer proteiD foun in nerve cells.~ rers nollly see to aonvt?y the chca (neurtntt) signrelea by one cell in a. rens in another cell. It is the relea of chemca

neurtrtt the bi of these ne1r to reptors, an th generonof a ieus in anther" cell th is th biochemica bas for ceU-fo-e1l cOmmuncaon

in the .bra In oth wo,. DeDS."ta" to, ea other by reeain chemca th binto re ~n oth cells, and if is the neu lltaking" to ea othe. th unesvaoUR mood feli an thöughts. By ac on rer prote, DMT an theoth 00 prent in Dae'alte the cell-toll communcaon, thereby cbgith ceUul "diogu". Th is the pr molecul mec whch unlies thchaes in t: feeling. an petion th oc afr ingesg Daie.

Page 3 -AMENED EXERT WIS STATE OF NICHOLA V. COZZ, Ph.D.

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. Is Dae Toxic?

There ar no credble reprt in the medcal litertu of over toxicity resulting frmDaime us. Also.. frm. a toxicologica. viewpint. thre is noth pacUlariyreable abut th chemica stctu of DMT or th oth compounds fOUnd inDaiè th WQuld sugg th thes molecules Would be chemicaly dam to cells.In fa in a sty conducte in the Bralia Amazn. in which. Daie usrs were

~ to matched coIlls. the Dai us reveed a high futiona st with noevide of penait or cogntive deloron (Hum Psychpbalogy OfHoa A PJ. Halucoge Use In Ritu Co In BraL CS Orb; DJ MçKemJe Cawa; OS Bri; ES Neve: G Obe OL Saldo; B Lagain; C .Tacla; CT'Mida RJ. SJS$: K. Boon. J. Nør. MBIt DI8., 184, 86.94 (1996)): In il met-

. anys of ni eaier stues on the pøëhlogiaa.eft of chc haucinge us(i LSD. psocyin. an mes bu not Da). it wa coi~ th tew. ifan, lo-te nourchlogiCf. dets co be atbu to th us of th.. su (D Hånö Cå Resdua Neucholo¡lCa Toxicity? JHHa .HO ~opo. Dr A,lcohDl nepøn.. 53, 247..256 (l99D. Ncvie anyøu ca be toc in sucicmy hi amui. . Th po to ca a toXicam ofDae te is, howe, pÍoa~ fo tl foDowi ren: Danity pi Dause an'vomltl in th amou CO f' ieous pu.Ths na lits th amunt ofDa tf ca 'b Ines th pu ef ma .it viy ~ible fo a h~ be to coe enuø Da te to exc;. to; TJ ida co to moa ot su ta by moutlDlud overth.co an pnptoD di wh su a fa.. me do not ex As. anas. th :v pi by :Qaic te.is J1t consde to be .a underale ef1) Dae uS. 'Is Ìl be 1h reous us of~ai eoD8de ~ vomtl to beaJJ of.toxins ft th.bo. . ..AS is. cr fo. may phlo¡ica ac su th ma be ~ODbe Da ~ od medcaon. In pucu, a pe who.ha be pibè. ce andestu (ilud 1rcylic ~ ìeeae se Ï'ìnhlbl an molI oxicl iìto) or wh UB ce ovetJt cold

. ..rees (~y thSe conlng.. phey1e. or pa) øJd. no.. in DiI les a pobly ~ou di-d in oc. Th Inon c:lr1P a øoec ."hve cr" ci by se hea elCM blPf sh of bm an an. In adon ot pijJoD dr (e.s.~ B8 me08) ~ soe fo (0:.. avo. ap ch sh) contQO th. 8f ii by th Il ei ~ ar ii by tI. ~ in Da It is po"ble th in th )Jie of Da th' COcoel re i~1s in th ~ th wod pr to art of an e1 I 8l liortb Sa Da CJ le ai cay tr to obt iD itmpr cb ~ be adlnJs Da to pr su cIIn &o 0C As no by th Bi Dr Co's re th ha""DO pJ pmblem np 88 a I8 of l8 Da IU th thac .. picetn Is effve. I havo prvi a list of contea .~ to ai in nwew th m~ca st of pens to debie whth shd.avoid, dr th te.

Pa4-AMBD BXT WlTs STATE OF NICHOLAS V. COZZ, Ph..

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Dru Control Policy

Accrdig to Federa reglations (TITLE 21 : FOOD AND DRUGS CHAER 13 _DRUG ABUSE PRBON AN CONTROL SUBCHAR I - CONTOL AN

. ENORCEME Par B - SECON 812; 21 USC Sec. 812 01/22/02), drgs arrecte in thir avaiabilty 8crdg to th critea: mèdca us, ability' to produce

phcà or psychlogica depedence. and ábtte potental. ~s ar asigned to one t)ffive cagories (Sçes) bas on "Vous 'combinons of these th criteri

. Reg .the fit crteon,. tte as of Daie in a religious context is not Prilyinteded 'as a ''medca'' us (i.e. it is non--g US, although th is in clinica

evdence tht ieligious expence and spirtWity have beficial effects on a pen'sheath). . With re to physca . or pschologiça depdenc thre ar neithanecota rert nor reor in the medca litera th Dai ~ pros eitherCOtion. Th is, ther ar no indcaon th D8Im~ us fel compelled to contiueus eithr beus of PSchologcal crvin or physical ne. Wh ca be sad of Daein te of abus pote?~ Cey~ it is a 'dr th 40e not se to len itself.wellto caua us .It is not parculy convenent to pr nor is the.dr paatble. As

. no ealier; it- oftn ca naa an vomiti. Be of its pugatve effec th.amount ib ca be consed is limte. Togeter th considerons suest tht

. Daie ha litte or no abus pote~a1..'. .The re na of'Dae is only apat when. its intndd use is regi. The

. inteed us' of a suce, eslally for religious us in a sttu se with the .goa of enclng one's spirtu bein ha spia signca. Reliious belief ar

am th mos pèii .an POteally lifeimprvi fore in. hu cultu. It isapnt th sano Da Chur' membe ar abSoiutly siee in th religiousbeef antl th Daie te is. for th peple a me to aceve grr spintufußmen. Fuerore, Dae is us unde reponsible, contl.ec condtiOD&. Forth re~ the us of Dae by th Sato Daie Chur should be held in the S8e

hi es. an aford the sae legal proteQns th ar .prvide to oGier religions.Th .non-d us of alcohol (wie) 'in regious Clonies such as th Calic'Ma isnot cons abùs; inde if is Pro. Likewise while peyote is claed as a

dn of abus un the Contrlled Subce Act of th Unite. Sfa. th non-dg us.of peote ùi Nat AmerCl Churh ceemonies is regn as a spial Sion anis not consder ab; lie the religous us of alcohoL, it is al Pro by law.Clealy, th us of Dae te in religious ceonies conduct by' th Santo DaieChu.fa ui th sae cagor ~ th religious .us of alcohol .or peyote: it is non- .drg use. It, to. shuld be legålly prte. . ,

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. At the reuest of plaitiffs' counel, I have reviewed the two-page document. mared PlaíÍiffs' Êxhiõit 4, which is the reort analyzing the tea sei~ from plaintiff

Goldn in May 1999. The docent conta report of the analysis of several exhibits .contaning dietyltrtane (DMT). The concetron of DMT in each exbit is.expessed in mglmL, and eah exhibit conta differet concéntatìons, ranging frm

0.27 mglmL to 0.84 mglL. . The totå amoun ofDMT in ea exhbit (AM. OF PURDRUG, ~olui ~2) is obtaed by multiplyig the cotrtIon by th tota volume of t.e

respective e~bit. For exaple, on Exhbit 4'8 secnd page, the-cncentron ofDMT inExhibit 4A is repor as 0.27 mglmL (colum 29 an 30). The tota volume of Exhbit 4Ais given as 13.40 L (= 13400; ~lui 33). "rus, 0.27 mglmL x 13400 mL = 3618 mg =.3.618 g; tls is J'unded to 3.6 g. (colum 32).

. The amount ofDMT reuir for psychoactive effects is approximely .50-100 mg (see for examle, ht:1/ww.usdoj.gov/deapubslabus8-hau.htmsilocýbin).At the concetrons reort in Plaitiffs' Exhbit 4, one would nee to consue100-150 mL (roughy % cup) to prducø p.sychoactive effects.

I have not teifed in the past four yes in cour or by way of deosition. Iwas påid approximaly $2,000 for coultaon an report wrting seces. .

. The stents se fort in th.doent-ar my own an are b~ on myeducaton an ex~ence. Put to 28 USC § 1746. I delare under penty of perjurtha the foregoing is tr an correct .'

. DATE ths.. day of ~QVf.ßF;~iO8.

NicholasV.

Page6 - AMED EXPERT WISS STATBM OF NICHOLAS V. COzz Ph.D.

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EXHIBIT A

TOAMENDED EXPERT WITNESS

STATEMENT OFNICHOLAS V. COZZI, Ph.D.

Case No. 08-cv-03095-PA

E-filed 12/1/08

www.bialabate.net

Nicholas V. Coz, Ph.D.Depar~t ofPhaology

University of Wisconsin School of Medicine and Public Health'Madison, WI 53706

608-262-7596 cozz~sc.edù

CUCUUM VIAE2006-present Faculty AssociateSenior Scientist1996-1998 Senor Resech Assoiate

Dr. Arold Ruoho, ChairDept. of PharologySchool of Medicine and Public HealthUniverity of Wiscnsin-MadisonMadis, WI 53706

2005-2007

. .

Dr. Jane Hopp, DeanDept. of Natul and Health Sciences

Caroll College

Wauesha, WI 53186

John Sem, CEPhysioGenix, Inc..10437 Inovation Dr.

Wauwatosa~ WI 5~226

Dr. DaVid Taylor, Chair

Det. of Phacology and ToxicologyBrody School of Medcine.East Carolin UniverityGrville, NC 27858

Dr. Cytha CzajkowskDept. of PhysiologySchool of Medicine and Public HealthUniversity ofWisconsin-MadÎsonMason, WI 53706

Professor of Pharmcology

2004-2006Ditor of Phaology

1998-2004~sistat Professor of Phology and Toxicology

1995-1996 Postdoctoral Fellow

i 994 Ph.D., PhalogyThesis: Pharmacological Studies o/SomePsychoactive Phenylalkylamine: .Entactogens, Hallucinogens, and Anorectics.

Dr. Thomas RudyDep. of PhaologySchool ofPhacyUniversity of Wisconsin-MadsonMadiSO, WI. 53706

1992-1993 Resch Assoiate Dr. David NicholsDept.ofMedcinal ChemistrSchool of Pharmy and Pharacal SciencesPudu UniverityWest Lafayet, IN 47907

Dr. Molly WeilerDet.ofPhaologySchool of PhyUniversity of Wiscnsin-MadisonMadiso, WI 53706

School ofPhaUniversity. of Wiscnsin-Madison:Madison, WI 53706

1989-1991 Researh Asociate

1988 B.S., Pharcology and Toxicology

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200S-present

2007-present

2005-2007

2003-2004

2001-2004

2000-2004

2000-2004

1999-2004

1999-2004

1998-2004

1986-preset

1995-1998

1994-1998

Teaching

Course Directo, Instrctor: Physiology in Phacology (grduate course). Dept of Phaology,University of Wisconsin School of Medcine and Public Heal~ Madison, WI. Topics: homeostis, cell

strctue, movement acoss membranes, neuronl signling, sensory physiology, brin, muscle,endocrie, reproduction, cardiovasular system, pulmonar, rena, gastrointestinal, mebolism,immunology. .Course Director, Instrctor: Medical Pharcology (pofessional/graduate course). Dept. of'Phaology, University of Wisconsin School of Medicine and Pulic Health Maison, WI. Topics:

general prciples, drg disposition, autc and neuromuscular drgs, cardiovascular and blood

drgs, cetral nervous system agents, gastrointestil drgs, chemtheraptics, drg theray ofinflammtion, endocrie drgs, botaicals, toxicology, gene therpy, immunosuppessant agents, drgintetions.Course Diector, Intrctor: Phacology (professiona course). Dept of Natul and Health Sciences,

Caoll University, Waukesha, WI. Topics: general priciples, drg dispsition, autonomic andneuromuscular drugs, cardiovascular and bloo drugs, central nerous syste drgs, gastrointestnal

drgs, chemothrapeutics, drg thpy of inflammtion endone drgs, botaicals, toxicology, drginterations.

Intrctor: Physiologica Proteogenomics (graduate coure). Dept. of Physiology, Brody School of

Medcin, Eas Carolina University, Greeville, NC. Course coordinator: or. Alexaer Murhov.Topic: applications ofproteme anysis to drg developmet an toxicology.

.Course Diector, Intrctor: Phalogy Sem (graduate course). Dept. of Phalogy andToxicology, Brody School of Medicine, East Carolin University, Greeville, NC.

Intrcto: Molecular Phacology (gduate course). Dept. of Phaology an Toxicology, Brody

School of Medicine, Eat Caroli University, Greenville, NC. Course coorditor: Dr. TatyanNikolova. Topics: receptor kiases, neurtrsmitt transpÕrs, cell adesion molecules, sitedirected

mutageness, chimer positrn emission tomogrphy.

. Course Dirtor. Instctor: Labortor Research Technques (grduate course). Dept. of Phacologyand Toxicology, Br.o School of Medicine, Ea Caolina University, Greeville, NC. Topics:neurtrtt trspr asys, cell cultue tehniqu, polyer cha reaction.

Intrctor: Centr Nerous System Phalogy (graduate course). Det~ of Phacology andToxicology, Broy School of Medicine, Ea Caolin University, Greeville, NC. Coure. cordinator:Dr. Bran McMllen. Topics: neurotrtter receptors, gene knkouts, synptic vesicle storage andrelease mechasms.

Instftor: Cellar and Molecular Neuroscience (gruate course). Neuroscience Program East

Carolin University, Greeville, NC. Course cordinator: Dr. Edward Liebe. Topics:neurtrantt rectors, neurotrantt trs. .Intrctor: Medical Phrmcology (profesional/graduate course). Dept. of Phalogy andToxicology. Br.o School of Medicine, East Caroli University, Greenville. NC. Course cordintor:Dr. Donad Bares. Topjcs: gener prciples, reepto mechasm, dose-resse relationships,absortion, distribution, metbolism, excretion, pharmkinetics, drg intetions.

Visitig Profesor: Neurophacology (undergruate course). Dept. of Leg, Development, and

Speial Education, Norter Dlinois University, DeKalb, IL. Course coordinato: Dr. Thoma Robe.Topic: CNS agents.

Intrctr:. Phacology (professional coure). Dept. of Phcology, University of Wisconsin School

of Phacy, Madison, WL Cour coordinato: Dr. Thmas Rudy. Topic: cardiovascularpharmcology.

Intrctor: Envionmental Toxicology (grduate course). Center for Envionmental Toxicology,

Umverity of Wisconsin-Madison Madiso, WI. Çourse coordinato: Dr. E. Bur Olson, Jr. Topics:neurtoxicology, gatrintestinal toxicology.

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1989-1994 . Teacmng Asistat~ Phacy curculum (varous unergrduate Phacy courses). University ofWisconsin School of Phy, Madson, WI. Cour coodinator: Dr. Wiliam Mellon

. Grdute StudetsDr. Kevin Foley; received Ph.D. 2002Dr. Kevin DeSanty; received Ph.D. 2002Dr.LuA Cuthberon-Lucas; received PhD. 2001Ms. Jessica Gaskey

Servee

Educational Policy Council, Univerty of Wisconsin School of Medcine and Public Health

Year 2 Cuculwn Steg Commtte, Univerty of Wisconsin School of Medicine mid Public Health

Consutig Editor, Journal of Drg Edcation (md Awareness

Manuscrpt Reviewer: Jou;"al of Neurocheistr, Journal oj Neural Transmission. Archives. of Toxicology, eNS

Neuroscience & Therapeutic

Research PrOposa Rtviewer, Depart of Vetes Afair, Offce ofExtel Reviews, Neurobiology-D

Telemedicine Distance Learg Commttee, Brody Schol of Medicine, East Carolina Uiiiversity

Neurscience Sterig Commtt, East Carolina University

Neurience Syium Orgag Cott, Bat Cali UniverityNèuriece Do Progm Cuulwn Cott, Ea Calin UniversityJudge, Doctoral Student Reseah Day, Brody School of Medicine, East Carolina University

Honors/Awards

Univeity of Wisconsi Profession Developent Grant. Awarded 2008-2009

Nationl InsttUte on Drg Abus Grt DA017675: Amphetamine-Related Photoanity Probe. Awarded 2004-2007

Broy Basic Science Incentive Awar, Broy Schol of Medcine, Eat Carlin Univerty. Awarded 2001

Excellence in Teahig Award, Brody School of Medicine, Eat Carolin Univerty. Awar 2000Youn Investigator Award, National Alance for Research on Schiphra and Depression (NARAD)~ MolecularStrcture of the Antidepressant Bindng Site on the Seotonin Reuptake Transporter. Award 1997-2000

Presentatlons and Scholaly Aetvities

2007 UW School of Medicine and Public Health Tea Membe, Enhancing the Professional Cultue of Schools ofMedicine: Relationp-Centeed Care Intiatve Imerion Conference ß, Indi Univerty School of Medicine and.

RegentrefIntitute, Indianapolis, IN. Host: Dr. Thoma Inui

200 Parcipat, NH Sumt Workshop on Prictive Toxicology Nß Camus, Bethesd MD. .

2003 PhysioGenix Milwaukee, WI. Topic: New Ways to Skn a Cat. Host: Dr. Howard Jacob.

2003 Discover Chel Unsolved Hitory. seres: Salem Witch Tris. Topic~ Stabilty of ergot alkaloids underconditions of extreme heat. Producer: Sue Houghton. Firt naonl airg 10/22/03.

2003 Dìsovei Chel Unslved Histor seres: Death ofMalvn Moe. Topic: Pharmcokinetics of pentobarbitalabsorptfon. Produce: Dr. James Younger. Fir national airg 10/01103.

2003 Deparnt of Phaceutical Sciences, University of Wiscon School of Pha, Madin, WI. Topic:Another Way To Skin A Ca(hinone). Host: Dr. Thoma Rudy.

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2002 Departent of Cellula and Molecular PlÙcology, Chcago Medical School, Finch University of HealthSciences, Nort Chcago, IL. .Topic: Novel Monominergic Agents. Host: Dr. Fracis White.

2002 Deparent of Chemstr, East Caroli University, Greeville, NC. Topic: Novel Monoaminergic Agents. Host:Dr. Chi~-yu Li.

2001 Depart of Physiology, Eat Car~lin University, Greeville, NC. Topic: Probing Monoamine Transporterswith Aminopropiopheno.ne. Host: Dr. Alexader Murhov.

2000 Deparnt of Medicin Chemtr and Deart of Phalogy and Toxicology, Virgiia CommonwealthUniversity, Richmond, VA. Topic: Mapping the Serotonin Reuptake Transporter. Host: Dr. Wiliam Devane.

1995 Invited Speer, The Rainorest Pharcy. Massachusett Còllege ofPhacy, Bosto MA. Topic: Drugs oltheRainforest: A Plirmcologil Sampler. Host: Dr. June Riedinger.

1991 Panel Mem, The Bridge Conferce. Staord Univeity, Palo Alto, CA. Topic: Drug Education at the CollegeLevel. Host: Dr. Thom Robe.

1991 Univerity of Wisconsi Medcal School, Madison, WI. Topic: Nere Gases: Meclinisms of Toxicity,Physiologial Effects, and Antdotes. Host: Pre-Medical Student Association.

PublicationsReferee

D Fontalla, M Johaesse AR Hajipour, NY Cozz MB Jackson AE Ruoho. Th . hallucinoge N,N~dimethyltrtamie (DMT is an endogeous sigm- 1 reeptor regulator. Scene (in pres).

SD Bradt, SS Tirayanpur S Free, N Dester, SA Barke, PF Daley,. NY Cozz, CPB Mas.Microwave-accelerted synthesis ofpsychoactive deutete N,N-dialkylate-(a,a,fJ,P-l-trtamies. J. Labelled Cpd.Radiopham., (in press) .JM Dorsey, MG Mirda, NY Cozz, KG Piey. Synthesis and biological evaluation of 2"-4~fluorophenoxy)-2-phenyl-ethyl pipenes as sertonin-selective reuptae inbitors with a potetially imroved adverse retion profie. Bioorg.Med. Chem, 12, 1483-1491 (2004)

NY Cozz, KF Foley. Methcathone is a substrate for the serotonin uptae trer. Pharmacol. Toxicol., 93,219-

225 (2003)

KF FoIey, NY Cozz. Novel amoprpiophenones as potential antidëprests. Drg De. Res., 60, 252-260 (2003)

KF Foley, ME Van Dor MK Sievert AE Ruoho, NY Cozz. Steeospecific inbiton of monoame uptae trsports

by meta-hydroxyephède isomes. J. Neural Tranm., 109, 1229-1240 (2002)

KF Foley, NY Cozz. Inbiton of trort fuction and desipmie bindig at the humn noraenline trsport byN-ethylmaleim~e and protection by substrte anlogs. Nauny..hmiedeheg's Arch. Pharmcal., 365, 457-461 (2002)

NY Cozz, KF Foley. Rapid and effcient metod for suspendig cells for neurotrsitt uptake asys.Biotechniquè, 32, 486-92 (2002)

RA Sewell, NV Cozz. More about Paronism aft takig Ecsty. N. Engl. J. Med, 341, 140 (1999)

NY Cozz MK Siever AT Shulgi P Jacob m, AE Ruoho. Inbition of plama membre monoamne trsports byß-ketoamhetanes. Eur. J. Pharmol., 381, 63-69 (1999)

NY Cozz, AE Ruoho. Radiosythsis of iiimeathnone, an inhibitor of monoae reuptake transprts. J.Labelled Cpd. Raoplirm., XL, 927-933 (1998)

NY Cozz S Frescas, D Maona-Lewi X Hua DE Nichols. Inda anogs of fenure and nodenfuramehave reduced neurotoxic potetial. Plirmacol. Bioche. Beliv. 59, 709-715 (1998)

NV Cozz, DE Nichols. . 5-HT2A reeptor antagonsts inibit potasium-stmulate gamm-aminobutyc acid release inrat frontal cortx. Eur. J. Plirmaol., 309,25-31 (1996)

AP Monte, D Maon-Lewicka, NY Cozz DL Nelson, DE Nichols. Coormtionly restricte teydro- 1-benzxepin anlogs of hallucinogenc phenethylaes. Med Chem. Res. 5,651-663 (1995)

www.bialabate.net

AP Monte, D Maona-Lewi NV Cozz, DE Nichols. Synthis and phaological exmination of bezofuaninda and te1lin analogs of 3,4-(methylenedoxy)ahetaine. J. Med. Chem., 36, 3700-3706 (1993)

H-J Le, NV Co~ MI Weiler. Age-relate differces in the effects of some muscac agents on acetylcholinerelease from rat neostratal slices. J. Pharmcol. Exp. Ther., 258, 496501 (1991) .

Abstracts

NV . Cozz AT Shulgi PF Daley, A Gopalakshnan, LL Anderson, JT Feì, AE Ruoho. PsychoactiveivN-dialkYltrtamines modulate serotonn tr by at leat two mechaisms. Soc. Neurosci Abs., 34, 536.17 (2008)

D Fontalla, M Johaessen, AR Hajipour, A Pal, NV Cozz MB Jackson, AE Ruoho. ivN-dithyltrtae (DMT)

as an endogenous ligad cadidate for the sigm receptor. Soc. Neurosci. Aba., 34, 66.10 (2008)

NV Cozz, A Gopalakshnan LL Anderson, JT Feih AE Ruho. ivN-dialkyltrtamies inbit plasma membrane and

vesicular serotoin trrt. FASEB J., 22, 714.10 (200S) .NV Cozz, KF Foley, D Fontala; A Gopalakhnan AE Ruoho. A novel amhetamie-relate photoaffinity probe.FASEB J., 21, 715.2 (2007)

DM Raffel, W Chen, YW Jung, DL Gildersleeve, NV Cozz. (uCJ-Phenethylgunidines: tror kinetics an binding

affnities for the hum norinephre trsper. J. Nucl. Med., 47, 72P (2006) .. .RJ Roman NV Cozz, SH Nye, AI Ðahly-Veron, JF Baye, DL Evan, VA Evrd, SK Korb, LH Lapczyki, JAO'Coor, IU Vernon, AL Wittnburg, IU Jacob. Combintorl rat panels for predictive toxicology. Toxicol. Pathol.,34, P27 (20Q6)

AL Wittenburg, JA O'Conor, DL Evan, VA Evrard, LH Lapczyki, SK Korb, HI Veron, SH Nye, NY Cozz, AIDahy-Vernon, il Jacob, RJ Roma Accelertion of diabetic nephropathy in the T2DN rat. Amer. Diabete Assoc. Abs.,66th Annual ScientificSesions, 21S6-PO (2006)

. JA O'Connor, LH Lapczyki, AI Dahy-Vernon, VA Evrd, DL Eva, AL Wittburg, SK Korb, SH Nye, HI Vernon,

NV Cozz, IU Jacob, RJ Roma. Delay in.the progression of diabtic nephropathy in the T2DN rat. Amer. DiabetesAssoc. Abs., 66th Annual Scientific Sessions, 21S5-PO (200

JA O'Conor, AL Wittenburg, MF Pere, LH Lapczyki, DL Evan, VA Evr~ SK Kor, AJ Dahy-Veron, HJVeron, SH Nye, NY Cozz, HI Jacob, RJ Róm. Diabe-indued nephropathy in th T2DN rat. Ame. Diates

Asso.c. 66th Annual Scientifc Sesions, 773-P, (2006)

VA Hargtn, SK Korb, NV Cozz SH Nye, AL Wittburg, HI Veron, DL Evans, JA O'Connor, LH Lapczyski, AIDahy-Veron, JF Baye, RJ Roma HI Jacb. Using PhGeix rats to detet tacre hepatotoxicity. Clin. Phaol.1ñer., 79, P82 (2006) .NV Cozz D Maona-Lewicka DE Nichols, A Goki KF Foley. Novel amopropiophenones as antiobeity agents.Soc. Neurosci. Abs., 31,533.5 (2005) .

SH Nye, NV Cozz JF Baye, DL Eva, VA Evrrd, SK Korb, JA O'Conor, IU Veron, AL Wittburg, M Hessner, XWang, HJ Jacob, RJ Roma. Does the lack of genetic diversity in anil models curently us for safet teing put the

public at risk? FDA Science Forum Abs., 305 (2005)

KF Foley, RA Galbrath, A Gokin, NV Cozz. Novel amopopiophenones as antiobesity agents. Exp. BioI. 2005 Abs.,7290 (2005) .SH Nye, NV Cozz, IF Baye, AL Wittnburg, SK Korb, VA Evrd, RJ Roma; II Jacob. Improved rat moels forpredictive toxicology. Soc. Toxicol. Abs., 44, 1897 (20OS)

SH Nye, NY Coz JF Baye, AL Wittburg, SK Korb, MJ Guy, RJ Roma, HJ Jacb. Phagen: a combintorial ratpanel for predictive toxicology. ToxicQI. Pathol., 33, P53 (2005)

DM Raffel, W Chen, DL Gilderleeve, YW lung, NV Cozz. Transprt of (lle)meta-hydroxyephedne, (lJe)-epinephre, and biogenic ames by the hum norepinephre trsprt. J. Nucl. Med., 45, 216P (2004)

NY Cozz KF Foley. Stiulant and antidepest-lik effects ofnovel arlketoes. Soc. Neurosci. Abs., 29, 757.11(2003) .

www.bialabate.net

NV Cozz KF Foley. Methcathone is a substrate for the setonin uptae tr. Soc. Neuosci. Abs., 27. 814.10.(2001) ..KF Foley. ME Van Dor, NV Cozz. Steeochemcal effects of meta-hydrxyephede isomers at monoamine uptatrsports: a s1rctue-~tivity stuy. Soc. Neurosci. Abs., 26,819.20 (200)

NV COzz KF Foley. Bromie substitution at th ring 3- or 4-positión of methathone ences potecy at seotoninupta transprt. Soc. Neurosci. Abs., 25, 678.17 (1999)

NV Cozz MK Sieve AT Shulgi P Jacob Il AE Ruoho. Methcathone and 2-meylamio-l-(3,4-methylenedioxyphenyl)propa- 1 -one (methylone) selectively inhibit plas mebrane cateholamine reuptaketrsportrs. Soc. Neurosci. Abs., 24.341.8 (1998)

NV Cozz, AT Shulgi AE Ruoho. Methcathone (MCAT) and 2-methylamo-1-(3,4-methlenedioxyphenyl)propan-l-one (MMCAT) inbit i3¡iserotonin uptae into hum platelet. Amer. Che. Soc. Div. Med. Chem. Aba., 215, 152

(1998)

A Boileau, NV Cozz, P Chen, C Czajkowski. Idetification of GABA- and diazam-resnsive regìons of th GABAArector ušing 12/0.1 subunit chimer. Soc. Neuosci. Abs., 22, 509.3 (1996)

MH Weiler, D Katz; H.:.J Le, NV Cozz K Das Gupta. Inositol phosphate (l) acumulation in rat neostratal slicesunder conditions used to inontor neurotrsmitter releae. Soc. Neurosci. Abs., 17, 173.9 (1991)

Invite Reviews and Oter Publications

Book review: Psychedelic Medièine: New Evince for Hallucinogen as Treatments. TB Robe, MJ Winelma, Eds.Preger/Greewood, Westrt, cr (2007). ISBN: ()275-99023-o

Contributig Editor: Psychedlic in Alteratipns of Consciounes: An Empirical Anlysis for Social Scientits, I Bars.Amca iisychological Asiation Books Washigton, DC (2003). ISBN: 1-557-98993-1

NV Cozz. SB-207266. an orally active S-HT4 receptor antagonist for the treatmt of irtable bowel syndrome. CurroRes. Serotonin, 3, 115-118 (1998) .Contrbutig Edtor: Peyote and the Native Amrican Church in Peyote. N Ross-Flangan. Enlow Publiser, Inc., NewJersey (199). IS~N: 0894908510 .Contrbutig Editor: Toxicity of Ecstasy in Ecsta Reconsidered, N Saunders. Turound Pr, Lodo (1997). ISBN:0953006506 .NV Cozz. SnZ-HT-919, a S-HT4 retor paral agonit for th treatmt of gasointestil motility disorder andintable bowel syndrome. Curo Drugs Seotonin ID Res. Alert, SDZ-HT-919, ISSN 1361 6285 (1997)

NV Cozz. A review of the chemtr and phacology of CV-S197, a S-HT2 recepto antagonist. Curro DrugsSerotonin ID Res. Alert, CV-5197, ISSN 1361 6285 (1997)

NV Cozz. Effects of water fitrtion on majua smoke: a lìtetu review. Multidisc. Assoc. Psychedic Studies, 4,

(2), 4-6 (1993)

Profesonal Affilations

Amrican Chemical Society (Dvision of Medcin Chst). iAirican Soiety for Pharcology and Expeental Therapeutics (Dvision of Neurophaology)Society for Neurscience

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PLAINTIFFS' EXHIBIT 4

ATTACHED TOAMENDED EXPERT WITNESS

STATEMENT OFNICHOLAS V. COZZI, Ph.D.

Case No. 08-cv-03095-PA

E-filed 12/1/08

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MARKS oft lAELS (Descibe ru~V) Selød 14. Subflltd PU~"~fRNo. (8 i:lr.e:l') ALLEGED DRUGS 1a. :;oc(

4 99093840 DMT 1 FIVE GPiIiOl' PLATIC ~GS B7'836 GG 87836 GG

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Net Vt. 30.78K¡ (30.'SL)NetYt. iO.34Kg' (20.S5L)Net ~t. 20.7 4Kg (20. 63L)

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, . ~ 30.351.)..z 9Q528 Oimeth~l ~ rvntaminé* 0.40 III!:lml** 8.2£ O.33K&.

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I EXBIT

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JUH 23 2000 15: 35 FR US RTTY EUGEHE 541 465 ~5B2 TO 93447146 P.03/04

"f JiiIJtleI\oa....~ .li....

REPORT OF DRUG PROPeRTY COLLECTED PURCHASED OR SEIze.nl Admlnlsrallon ...

JrAINED (Chee Op..ølii OSIib:ur OFrav Simplo :l FiLE NO. 2b. 'PROQRA 3. G-tlEPIDcoDe

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GOLDEN, Kat.bJ.eneGil. REFeRRINGAGENi; (NliMI) Ot. REFERRA _. .. . ~

o i: No GR 0 ti. Ni 7. DATE PREPAREDie.

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LABORATORY E~DENCE REceT REPORT19. NO. PACJ(OES 20. RECEIVEDi:ROM (SIl.."'re a Dale) 21. PJl21orTyi* NAM lIdTlTLf!

:a S~L 23. R ECEI,!E!D BY (Si,naluro ~ Dala)

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E~hib:l 4A con1:ajn. diethylti:yptalne anel haminè.S~oss Wt. 16.99Kq Net Wt. ia.30Kq (13.41L)4 .1(2e.32Kg (25.111.)), 4.2 tU.UlCg(:i6.35:LH, ~ .3rie..UKgU6 . 39LlJ "âhd 4A(lO.~6K9(1i.05L) Jheld for dcziti:uction, penclittg wi:i.~te", n~tificiit:iott, until "01/2"1/99.

Pa,qe 0:28. 27. 28. ~IV 0r,UG INGREDIENT CON~i;NlA"ON 32 AM.OF 33.&:~I ~~. ( Rehll or OGlYinn N.m.) 29. S1ngl ~Q. MUO\Tt 3t. Uolt PURE DRUG RESERV4J\ gO !'" 0 n, .. l'21 mrr/mi..... .3" Sa 1 ~. ?Qtctl

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~34. ANAlY$T(SIoNltuii) , 'j .p J¿ I.c-- 35.mi. -' ' .' , 36. DATE COMPLETEDtl.~i.a 1,. Vi;ticw f\/7.r' ." ~" .(1.. -

Forensio Chemst 071Z31"~. APrllOYliUl BY i:iigninui: D~.'1J æ.

i/t//fi 3e.11TL 3'. r.à. 1.0CA110n)nald t!hinn J..i _ Actina Laboratoi:V' D.ìree.t:or San F~~~cisco. CÄ

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541 776. 4263, . Pra~eoutlon

PAGE.ÐJ

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CERTIFICATE OF SERVICE

I hereby certify that I served the foregoing AMENDED EXPERT WITNESS

STATEMENT OF NICHOLAS V. COZZI, Ph.D. on:

Eric Joseph Beane I Brigham J. Bowen I Julie Straus I Lîly FarelCivil Division, Federal Programs BranchU.S. Department of JusticeP.O. Box 883, Room 7124Washington, DC 20044

Attorneys for Defendants

D by mailing a copy thereof in a sealed, first-class postage prepaid envelope,

addressed to each attorney's last-known address and depositing in the U.S. mail at Portland,

Oregon on the date set forth below;

D by causing a copy thereof to be hand-delivered to said attorneys at each

attorney's last-known offce address on the date set forth below;

D by sending a copy thereof via overnight courier in a sealed, prepaid envelope,

addressed to each attorney's last-known address on the date set forth below;

D by faxing a copy thereofto each attorney's last-known facsimile number on

the date set forth below; or

o by fiing electronically via the court's CM/ECF system.

DATED this iV-day of ~ ,2008.

TONKON TORP LLP

BY~N.~Don H. MarmadukeOSB No. 530727Direct Dial: 503.802.2003Direct Fax: 503.972.2003Email: don.marmadukeêtonkon.comAttorneys for Plaintiffs

097204\00001\1188593 vaoi

Page i - CERTIFICATE OF SERVICE

\

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