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Council for Tobacco Research

[Agreements Between Ctr and Bioresearch Institute and Bioresearch Consultants]

Date: 19 Jun 1970
Length: 8 pages
CTRMN042309-CTRMN042316
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Depository Date
08 Sep 1997
Master ID
Ctrmn00041967-2810
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Author
Homburger, F., Bioresearch Inst
Recipient
Hoyt, W.T., Ctr
Type
LETTER
CONTRACT
Box
267
UCSF Legacy ID
xmt30a00

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B10-RESEARCH INETITUTt, mconpoR:.-zo 9 COhKtCCIJI LJ!uUC CMt~RIJ3l,!'J31/lLMV3:TT5 02It1 1617, .a4•973s Mr. W . T. Hoy : Ezecutive Director The Council for Tobacco Researce - U. S.A. 110 East 59th Street New York, New York 10022 Dear Mr. Hoyt: ~. >/pr!! U ri! t X D. D:rr.rc Y.lEANFtIP. f~0. ~•..c>r!. 4rwa>ai. June 19, 1970 Enclosed are two signed copies of each of the agreementa the Bio-Research instin.:te (cortract .`:o. 4) and Bio- Researc_ Coa!=?:a=ts (t;sntr:ct N-a. 5). I shall b_ at your o_*ice on "'ues•=ay, June 2:, at 11 a.zn. to dis:uss some of the ad-atzistrative details and other ?ec3img rnazte:s ac :i you and Dr. ! iss.rti. lritn rnanv ths.nks ic= these co :trac:s aa? ~:ah `est reprds, T"t_:dr . _ Er.closu:es Yours sinctrely, . ~ Frecdy :?o rl~c;~:- ?.'. D. Prer.=en: and t IwoLrLnoulT ~ Y~:,•rnG!.^. OprRAr[o £[ZYSIVtIT fOR S=I:`:TiI:C A:.r CDUCaT:CtIdL *U11PClff CTR CCINTE2RCT5 005617 . CTR HN 0412-31-0-9
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( r ~. . ~ . ~- AGR:Ea..~'IIT SET.•7:EN THE COUHCIL FOR TOBACCO R.SEXP.C'-: - U.S.A. AND BIO-R.SEARCFi CDNSCLTl.ATS. I::C. This agreement covers research to be pes=o_-xd by Hio-Research Consultants, Inc. according to protocols aste`~iisherd Dy The Coun=il for Tobacco Fssearc! - U.S.A. and dated June 1, 1970. It is agzcad that the total charges for the stud:es accordins to these pr:txols will not eY.eed $75,000.00 for the tr:elve-oonth period be;innir=, Jz:.e'1. 1970. t:e prok-ose to nake paya.ant to Bio-casearch Consultants, Inc. on a c•zarterly basis within twenG, .! (20) days of receipt of erm invoice de:aili:,g char9es incurred u.•sde= the protocols. in no e•.,ent shall •r.e pay xre =iatn r.!net; (40t) ie:ceat of the charges unfer the protocols prior to receip_ of a ce-,:,ltte re=.;:t coverir.g thc 12-cooth period. Final pr.l'cent will te rade afte_ arprova_ by The Coum:.il's E:<ec~tive Director o`- this eo--Plete re;:ort r-verinq the 12-v.cnth period. It is agreed that a 12-mont3 re?:r: will be sub:it_e3 tc The Cca-ncil's :aecutive Director or other whc, he rt_.- tasi=:.cte. S: ould any tevietions fron the protocDls sae.,3 na:essa_~y dut :o results cbserve; e•_in; the co---se of the stuc;.:°-r.r._•-a::.l Co:stltsr;, Inc. will r.ct'_f•: =ae Co~;-ncil fe_ Tchacco Resa:_::h -..5... A.y p:epose= char.pe end tzy re•.•isicn in cost w'-11 be s•r:.`it:ed :=r a-:d wi=1 dt:c.-t`_ ==1 w•:it:l:' co::=i-:1t`-on a.-.?' aooro:al of Tre.Co*_:a_ :__ _z`a:=: Fscasrc: -_.5.. It is u.-.ee:stead and ag_ecd that a-y -_;e: s-_'s_.~ t:or.s to or c._.ges in thn =retccol ct i ch either perty te this e=slera' :-' yac reY _eat wii- :e covere= ty cutue::l, acceotable secarats :zit:c: ad`.t ::a to this a;:ea=s-t, an~ will re:uire t::e a=nroval of The Co_.cil's =xtc-ti:e C=rectar or *thcrs wya= he rc:i 3esis•n ete. - Shou1= st.y unforeseen clar.ce in circ_sts=css =a}:e i= anpre:::cte to c`==i or tezinate the study, ir.s C'ca::ca :or :_=ao^ ?saesr;'. -:.S.?.. s::el-_ 'a.•e t:e Yri:~ile;,! of doing so Lao- si=ty (6C. days .r_it=tn not_ce to Sio-R:caarch Ccasu_t;r:ts, Inc. Irn tha a:-ant of an_ s-:c: cr---ailaent uoth parties sia.l negc: iate retuced charges for t'e r.ecessa^; remainir.g se-rice. in case of terrSna_ion, no penalty costs or cthsr ea:a:.sos shall bc arsessec'.. All data obtained and all inver.tions, dc ~a_s:=aats, _indings o: discoveries w:^.ethcr or not oatentable, as:e by Lio-3ssaarch Cc=suitar.ts. In:n in tha course of, or as a roxult e=, xvri dcr:e under _'.is a;recsit she1i Le the sola and excl'_:ive preperty of l:hr Co•.olcil for =::ac~ Prsearci - C.S.A. Bic-Dssee=ci: Co:+su'_teunts. Inc. agrees to keep sscre: ~.= xnfi_ential an., :nfo:~ticr:, kncwledg4 or data octair..d in cot.necti:: w=:`., or as a rest_t of, work C:s under this agrea=,ent, and further a?raes =.--_ to use suc:: for itself cr fc.z otherd either directiy or i:+cireo_.::. or diselose it :a a::y t`ir.: _: arty outside of T!je Council for Teyacco Pases=_: - II.S.a. wit:: _. The Cru-cil's prior written approval. cTR c0NTRRCTS 0056 1B 11225359 CTR HN 04~~1+~
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1 - 2 - P.11 equi^aent. 2ocu_ents, books, records, r.otes or othe= =aarials or data furrisl~ec: by or on behalf of The Ccu.icil fer Te:acoo Fasearch - C.S.K. in coanection with tior< done under this agreer.ier.t ara11 at all tiees be the propertv of T:.e Co•_,cil fc: Tbbecco Research - U.S.A.. erd shalr be retu_:,ed by Bio-Rese&rch Consultants, Inc. to the recpective o•aner as designate_ by The Council for Tobacco Rese_ ch - G.S.`. at the tezr.inatioc of this eyseemezt, or at tny time that The Council for Tobacco 3tesearcn - t'.S.l.. nay rea:est. If the te_--ms of this agreem-snt rse SLtisfaCLOry, please sign and date both copies c_ this lettes and return one copy tc The Council's Executive Director. Sincerely yours, TEO COV:ICIL FCR T:ZACCO RESE.A.RC: - U.S.A. T =xe-uti•.e Director ~ P.C~•a==o: 3:0-=-"~az=ZC= CCVSG~a =._~. L::C. / _:. . --- -:,-;.~ ~...~.- 3Y -G CTR CaNTRRCTS 005619 w j 11225360 CTR H~~ ~~~.~ ~ 1
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irM COUNCIL F0R TOB3CN RFS=ARCH - U.S.A. PROK.COL8 &I%'-) F:CFOC PLA.v F: I =r. BIO-:LESE?.?.CIi COXSULTaNTS, Cc-cridse, :Se3a. for =r.E Ds*ES ~..--_o.; =' -`~ rss~ ..:~~s or ".= ==L7E., Sv--AIltr: :~_._:I?t !::•0_.. F02 B ~ X W CTR CQNTRRCTS 005620 ~ 11225361 W' 7 a! 1 ! 1N 042312
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i f ^ St0!'1=.R." This is a 1'ac_-sti, conzidentiel a;se_^eit as eoatair.e= in the atta;heG forml ccr.=act. It is ur.de_stood that there will be an official :.onitor lia:son between the pttiezi as ir.d:cated er.3 a;.:ointed by The Co=cil fo. a^obacco Rese3rch - U.S.A. MTR-USa1. The renitor o_st be consulted for c,uestions of procedure and logist3cs before any chances can be honored. The tcnito: liaisorn will be e=ao•:nze= to %:ozk w_th 3ie-P.ese_c.h Conaultants, inc. (s-4;.I) as it pestains to this pr _a:ed ..:r.:___.. The im4a.a_c:: s_cdy will enc-.pass ebtaair.q irit:al to:_co:oyical data leading into aex?os•.::e, t^e ti^e dira:ic:: to be dete_-ir.e_ by :^e :.'TR-*-'5=A r+.o=ic-:. T: a ex_ e=inar.;cl desi: n cc•ntained h4:e'_= will inclu=e :,•o contrcis -- sna:-.-e.rcse= a:.E ca;: •..elc. _:^.e qrouis to be observed be iaa:a~a'_ c.^.d rair.t_jne`- a_ statist_ctll•r v.os%able :e•:als at al: t'__as or L~:=! ---- t`.:-e (: _-- _._ :;=ee-.s-_ o' ..._ C'_-~t-.=.. _._.'o: its r.o..__.._` as r.oz les> o: ...- -=- ~ z--=-'-s :e: _-_.. =:--ss a:.: o- lo;i=_- = rotct•ci cttT?ne. c~- --- hJ' OF ?=-n A. To d9ts =:ne t:s ..:_, :o: the t:~o s_rains of ha=sters -- (li "cs-ce: s_s:*;)tible" s=: (3l "iar::" or "canes: resis:en :" -- on i:'^.elet?c s of o'::oles=oke a:.= of -,.e qase:_s ;`asa c: sro;:a =res the "re'e:ence" ciQ6SLLte. • B. To de:ermine o.-n stlec.ed erqars the lonc-ter.m e.:f-ts ef ch:o:.icall•; e::gosir.; tlir~s to ~::ole sra?;e t._ to ;aseou p~eee of s-:_ o: such ciqa:uttes. r X cTR coh(TRACTS 005621 ~ ~ 11225362 CTR HN 042-3-13"
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- 2 - C. To date:=+ne t.tie rep-ciucib`_lizy o: the "Sa=:ic_ti D. To o3ttiur "tr.eated" a.-iirlia1s for acclit:onal studies su .h as vixvs pro:i lin; a.-id biochectiical tests as daterr..ined by The CTR-CSa c:c:x.itor. SUGGrSTEX PTr&`i OF TF?IS STCrDY A. InhalaGion of tnbacco sao:e stu3ies to be co.^.d~cte-=' using the waito-- Y.orrissey ltacaine. 1. This project will be involved p_i^.a=ily .:i=i W:;ostL:e o= aniot.ls to whole smc;e nnd latez to the gaseous -+'::rse. 2. ::e ciqa_ette to be us:a will be the ^e:e=e-ce Cigarette --anu=ccture3 by the Lr.iva=sity of Ker.tL=:y. 3. The anisis will be 5y:ian C-1den Fa:ste:s (:4eso=--icetus aurc=_s) . Sax will be deter-._::e'-. a) strai-s •.:i'.: be usei: 1) ?. -erZy s_-~.. - to =e ce:e:=- --. 2) A L. lAe-_ -~_ be ...- conlt.:~:s: 1) c^.n--s=~':a:. 2) C==e-1e1Z. 4. _~5` va1•:as be d:`e:-a'-.si for __:h s-La. us:n; .._ less t_iar: !i•,e le•:tls _-- dose •:itf i: ai:=,a-s p=: cc:r,.arao:vs c: az±-.s:s' res: onse to s-3o::e s-d nico:i.^.3. 5. :axL=m-to:e=ttad dose will se =eC._:_:.ed '__ rc:n st-_a o.^n a c==onic bnsis, inc).__in; d•_ati:n of eras•_e et varios degrees of dilu=icr. c: s-oks with c=r ar.d st4df c` blcc-' leve_s of carbon acnoxide attained a.-id the at?:o:(i-'1 re:a oi CO eli"il-etior.. CTR CQHTRACTS 005622 11225363 C TR IIN 042 ,314,
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- 3 - 6. Lcng-ra,.ce lifetiee (;X-,e:r.ents Wil? :e i=tiate=. ^he e•r-re^=e::. aay be ter-mainated whe:: on).v 1/3 c' the er.cse3 Z_tirnals are survivino_, or net less t:•.en 16 _cat:-s. The C?R-GS:A r.cnito= uill be consulted before t_e exptrir.snt is te_-air.ated. a) Cbservatio:u will be aaZa on: 1) appeara.%c: of coat, color, eyes. 2) Aeaetions of tninsls,to :zndl:ng. 3) Bod; r-eight at vesily inte:veis- b) D,._in: t:._ first -rer= a speci e1 ..•iil be a^.de cn :.-sters e.r-_ose3 to s-n::e S:'^.i'_etic::. F.t t=.e i-itia:ic:: of _`.e p_cy=e.•, ar.d e::; _ c.on_^s _ne:___`=-=• six en:a.il! K_-. -e sec__ficed fr..w ea:.. croup `o: ,.._ `o11ea_^; ex+_::a__ozs. 1.) Ei.r^.e:1LCai xaasl'te..e :r. (a) CO c= car!: ::.ryie_=;=o::z :n ~-,loor:. (b; U_--:_-e ss _aa __-' -- -_--t or 2) (LI GC_6S b:G_:1, C:}:E:i. . (0 Orsa-. i,!:C-.i_D 4s-z tcia"% 3) Set.icns of tas.e= to .`.s =t_f .... or (b) Piz:.i:Lz-y . (c) Lunc,s and selecte_ 4) Se:c_=id se__as cf e_-.:rsla ei_:en at rsndo= u; be re;vl:edd ;`e CCR-Z75:A ro^it=_ to te sen t .o eco_ert'°-.; 2cy._etcs:ee, i._ , for vixu: -:c'_'_:e or tes.s. CTR CCNTRRCTS 0056223 11225364 C) f'r f i) 7 0S"°, .~ . 3.f. 5
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) - 4 - 5) ;k.t terr-4r.s=ie:. all L.i.=ls are to be e_t~: siec. (a) All organs are to be exa-ned ;=ossly. (b) Lu,:gs Le to be chec)ce3 for tu.-ors. (c) Pituitaries are to be ex-ir.ed for tc:.czs. (d) Salacted tissues ase to te sent to the pathologi st. B. Re:etit.ion of 5a=fiotti's rodal for induction of squa=aus cell casc:ao..a, tsing henatite a-nd hydrocazbo:i (`:C: in the EIO 15:16 hrratezs. 1. Intratsa_,eal a-1-.inistzatic.^n of heratite -ait:n BC a.cordi-g __ Saf=io::?. 2. iapotitions w_;h proyress:•:ely la++e_ eoses cf EC for cetez-_'::at:or. , of the "oritr.z" dose. 3. 1:=r~nist:at±on of her%--tite end ::C d-•se w__, s=...- _..._-:ss_- in adcii tior.. 4. -.-..:r.:...--_-c- _= he-.a:-:e an: toba.=c= s=._ eo`---s!.*_s 5. Ls=er a=..- :_ -'at:.;_ra:e= si to hLa:].tE Mi= CTR CO~~(Tt~acTS 00561~ N 11225365 W TI 4 I •) ) 0]2~.a' w/+ 1S

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