ARCHTVE
`
`archive.org
`
`AF'FIDAVIT OF NATHANIEL E FRANK.WHITE
`
`1. I am a Records Request Processor at the Internet Archive. I make this declaration
`of my own personal knowledge.
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
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`5. The Internet Archive assigns a URL on its site to the archived files in the format
`in yyyy][Month in mm][Day in dd][Time code in
`http://web.archive.org/web/[Year
`hh:mm:ssl/[Archived URL] aka an "extended URL". Thus, the extended URL
`http://web.archive.org/web ll9970l26045828lhttp:llwww.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26,1997 at 4:58 a.m. and 28
`seconds (1997101126 at 04:58:28). The date indicated by an extended URL applies
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`6. Attached hereto as Exhibit A are true and accurate copies of screenshots of the
`Internet Archive's records of the archived files for the URLs and the dates specified
`in the attached coversheet of each printout.
`
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`Docum€nt
`ld: 7E781 D40-AFF0-1
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`1 ED-9E58-75391 81 FFF26
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`Page 1114
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`MPI EXHIBIT 1014 PAGE 1
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`MPI EXHIBIT 1014 PAGE 1
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 1 of 14
`
`

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`7 . I declare under penalty of perjury that the foregoing is true and correct.
`
`DATE:
`
`02/tg/2c.23
`
`fkflrt'r;"L f'"t'''L -W h;î'
`Nathaniel E Frank-White
`
`ARCHIVE
`
`archive.org
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`Document Notarized using a Live Audio-Video Connection
`
`CHIRAG PATEL
`ELECTRONIC NOTARY PUBLIC
`COIUIMONWEALTH OF VIRGINIA
`NOTARY lD: 7679556
`COMISSION EXP: JUNE 30,2024
`
`Pleaso see attachod
`All Purposê
`Jurat form
`for additional
`Notary Evonts
`
`Document ld: 78781 D40-AFF0-1
`OnlineNotary.net
`
`I ED-9E58-7539'1 81 FFF26
`
`ll
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 2 of 14
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`

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`EXHIBIT A
`
`Do@mEnt ld: 7E7B'lD40{FF0.1 lED-9E58-7539181 FFF26
`Onl¡nsNotary.ngt
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`MPI EXHIBIT 1014 PAGE 3
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 3 of 14
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`

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`https://web.archive.orglwebl2OLLL227072635/https://clinicaltrials.gov/ct2lshow/NCT0085t773
`
`Document ld: 7E7BlD4o-AFFS
`Onl¡neNotary.nEt
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`l lEO-9E58-7539í8'l FFF26
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`MPI EXHIBIT 1014 PAGE 4
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 4 of 14
`
`

`

`üluItilfllililiru 10 caplUles
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`Related Slud¡es
`
`SafeÇ, Tolerability, and Profile of Action of Drug In the Body of NN9535 in Healthy Male Japanese and Caucas¡an Subjects
`
`This study has been completed.
`
`Study NCT00851773 lntormetlon provided by
`Flrst Recelved: F€bruary 25,2009 Last Updat€d: July 15,
`
`Novo Nordlsk
`2010 H¡storvofchanges
`
`No Study Results Posted on Cl¡n¡calTr¡als.gov for this Study
`
`About Study-BesglgBepgd¡ng on Clln¡calTr¡als.gov
`
`Study Slatur: Thi6 6tudy has b€en complÊted.
`
`Study Complètlon Dale: October 2009
`
`Prlmary Complêtlon Date: October 2009 (Flnal data collecllon dâte for primary outmme meâsure)
`
`CadÊcl-HclP-ÞÊ!l
`Lisl€r Hill National C€nrêr fôr Biomediæl Commüniætiôñs, U S Nâlionâl L¡brary ol Modicine,
`[.J.S. Nat¡onal lnstitules of Health. Us-DeædoeofefteaX¡Åtl$ê¡]sti6,
`lJsÀsq. COpylSN. PIiKy Accessibilily. Fr6êdom of lnro¡mal¡onÂcl
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`OnlineNotary.net
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`MPI EXHIBIT 1014 PAGE 5
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 5 of 14
`
`

`

`https://web.archive.org |web120LL1022103538/https://clinicaltrials.gov/ct2lshow/NCT0085L773
`
`Documgnt ld: 7E781 D4GAFF0-1 1 ED-9E58-75391 81 FFF26
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`Page 6/14
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`MPI EXHIBIT 1014 PAGE 6
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 6 of 14
`
`

`

`llll[ltillf|¡[û¡¡iilg 10 caplUlgg
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`
`Related Studies
`
`SafeÇ, TolerablliÇ, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Gaucas¡an SubJects
`
`This study has been comPleted.
`
`F¡rst Receìved on February 25,2009. Last Updated on July '15,2010 History-g¡.lQba¡ges
`
`Sponsol: Novo Nordisk
`
`lnformaüon provlded by: Novo Nordisk
`
`cllnicalTÌlâlÊ,gov ldentlñèr: NCT00851773
`
`Þ Purpose
`
`NN9535 in hèalthy male Japanese and Caucas¡ân subjects.
`
`Condition
`
`Hêalthy
`
`lntervention
`
`Drug: NN9535
`Drug: placebo
`
`Phase
`
`Phase I
`
`StudyTypê: lnteruêntional
`StudyDeslgn; Allocationr Randomiz€d
`Endpoint Class¡fication; Safety Study
`lntèruention Model: Parallel Assignment
`Maskingr Double Blind (Subject, lnvest¡gator)
`Pr¡mary Purpose: Treatment
`
`Off¡c¡alTitlê:
`
`NN9535 ln Healthy Male Japanese and Caucasiàn Subjects Afier Weekly Subcutânèous lnJeclions
`
`Further sludy deta¡ls as ptovided by Novo Nord¡sk:
`
`Primsry Outcome Me€sures:
`. Adversè events { Tlme Frame: at all scheduled vis¡ts (2 - 14) follow¡ng screening ì [ Designated as safety issue: Yes ]
`
`Secondary Oulcome Mea6ures:
`. Frequencyofhypoglyca€micepisodesITimeFrame:âtallscheduledv¡sits(2-14)follow¡ngscreoning][Dêsignatedassafety¡ssue:Yes]
`. Vitalsign6(bloodpressureandpulse)[T¡meFrame:atallscheduledv¡sit6(2-14)ìncludlngscreêning(v¡sil1)lIDeslgnatedassatstyi6su€;No]
`.12-leadECG(electrocardiogram)[ïmeFrâmeratallschêdulêdv¡sits(2'14)includingscreen¡ng(vlsitl)][Designatedassâfetyissue:No]
`. HâemâtotogyITimeFrameratallscheduledv¡slts(2-14)lncludlngScreenlng(v¡slt1)][Deslgnatêdassâfetyl6Êue:Nol
`. Biochemìstry[TimeFram€:atallscheduledvisits(2-14)includingscreening(vis¡t1)]lDssignatedassâfety¡ssu€:Nol
`. Urinalysis ITims Frame: at all scheduled v¡sits (2 - 14) ¡ncluding scr€ening
`(visit 1) ] [ Deslgnated as safety ¡ssus: No ]
`. Calcitonin I T¡me Frame: at screen¡ng (visit 1 ) and at visits 2, I and 14 I I Designated as safety issue: No ]
`. Antibody development against N9535 [ Time Frame: ât visits 2 and 1 4 ] [ Des¡gnated as säfety issue: No ]
`
`Enrollmsnti
`84
`Study Starl Dater
`Februâry 2009
`Study Complêt¡on Date: October 2009
`Primary Complêtion Datei October 2009 (F¡nal dala collsction date for primary outcomê m€asure)
`
`Arms
`
`A; Exper¡mental
`lnteruenlion; Drug:
`NN9535
`
`Br Êxperimental
`lnteru€ntion: Drug:
`NN9535
`
`C: Experimental
`,nteruentlon: Drug:
`NN9535
`
`D: Experimental
`lntêruentlon: Drug:
`NN9535
`
`E: Experimental
`lntervenllon: Drug:
`NN9535
`
`F1: Placebo Comparalor
`lnteryention: Drug;
`placebo
`
`Assigned lnteruentions
`
`Drug: NN9535
`0.1 mg once weekly, s.c. injection
`
`Drug: NN9535
`0.2 mg once we€kly, s.c. ¡njection
`
`Drugr NN9535
`0.4 mg oncê weêkly, s,c. inject¡on
`
`Drug: NN9535
`0.4 mg once wêekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. ¡nlêctlon
`
`Drug: NN9535
`0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once wêèkly for 6 weeks, s.c. lniection
`
`Drugr placebo
`0.1 mg once weekly, s.c. inject¡on
`
`Oocument ldr 7E781 D40-AFF0-l 1 ÊD-9E58-7539'l 8l FFF26
`OnlinENotary.net
`
`il Ïtl[]lllllllllllllililllllllllillr
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`Page7l14
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`MPI EXHIBIT 1014 PAGE 7
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`MPI EXHIBIT 1014 PAGE 7
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 7 of 14
`
`

`

`FZ: HIACeþO UOmpArator
`lnteruentlon: Drug:
`placêbo
`
`F3: Placebo Comparator
`lnteruentlon: Orug:
`placabo
`
`F4: Placebo Comparator
`lnt€ruention: Dfug:
`placebo
`
`F5: Plâcèbo Comperator
`lnt€rusntion: Drug:
`plåcebo
`
`urug: placeþo
`0.2 mg onæ weekly, s.c. lnjeclion
`
`Drug: placebo
`0.4 mg oncè weekly, s.c. inject¡on
`
`Drug: placebo
`0.4 mg onæ weekly for 1 wæk, 0.8 mg onæ wêekly for 7 weeks' s.c. inj€ctlon
`
`Drug: placebo
`0.4 mg onæ wækly for 1 week, 0.8 mg onæ weekly for 1 week, followed by 1.2 mg onæ we€kly
`¡niectlon
`
`¡njætions for 6 wseks, s.c.
`
`Þ el¡giu¡l¡ry
`
`Ages Elig¡ble for Study:
`for Study:
`G€nders Ellglble
`Accepts Heallhy Volunteers:
`
`20 Years to 45 Yeârs
`Male
`No
`
`Cr¡terla
`lncluslon Crlterla:
`. For Caucasiån or Japanese volunteers thè follow¡ng appl¡es:
`. lnlormed consent oþtalned before any trial-related actlvlties
`. Body wslght betw€on 54 and 90 kg (bolh inclusive)
`. Body måss lndex (BMl) between 18.5 8nd 24.9 kgh2 (bolh incluslve)
`. HbAlc below 6.0 o/o
`. Subjects who are considered to be generally heâlthy based on âssessment of mediæl history, physiæl 6xâminat¡on and clinical laboratory dâta at screen¡ng, âs judged by the
`lnvostlgator
`. Sub.iecls who arè sêxually actlvê ånd have pârtnêrs who are or æuld be pregnant are wllling and requirêd to use a bar¡èr method of æntraæption (e.9. condom) for the
`duration of the study and for 90 days following the last dose of study medication
`. Japanese passport holder, Japanes€-borñ parents, lived outside Japan for 5 years or lêss
`Exclus¡on Crlterlâ:
`. Any clln¡cal laboratory values devlat¡ng from or outs¡de the laboråtory relerence rânge unless considered not to be cl¡niælly signif¡csnt by the investigator
`. Any âbnormal ECG Índings at thê screening, consid€red
`to be cl¡nically slgnmænt by lhe lnvêstlgator
`
`haemâtolôgiæ|, neurolog¡cal, or psychiâtr¡c d¡seåsês or disorders, considered to be clinically signlficanl by thê lnvest¡gator
`. Previous rândomisod in this trial (not applicabls for 6lånd-by volunteers)
`. Blood pr€ssure
`in sup¡ne poslt¡on at the screening, after resting for 5 min, and in the standing pos¡tion atter standlng for 1 mln, consistently outside the ranges 90 - 140 mmHg
`systollc or 40 - 90 mmHg dlastolic
`. Heart rate in supine pos¡tion at thê screen¡ng, afrer resting for 5 min, consistently above 1 00 beats/min
`. Alcohol intske wlthln 48 hours prior to the screenlng and admission (examined by alcohol breath tê6t)
`. Hepailtis B surface antlgen, Hepallt¡s C antibodies or Human lmmunodefciency Vìrus (HlV) ãntibodies posltlve
`. Hlstory of signmcânl all€rgy or hypersonsltlvity
`. Known or suspected allergy to tr¡al productor related products
`. History of drug or alcohol abuse (alcohol abuse ¡s def¡nêd as ¡ntakê of more than 2'l units (U) we€kly: One un¡t of alcohol èquals 1i2 pínt (approx¡mately 250 mL) ot beer or
`lsg€r, or ons glass ofwine or Japanese saks, or 1/6 glll (approx¡met€ly 20 mL) ot splr¡ts)
`. Subj€cls who smoke more than 1O clgarettes, or thè equivalent, per dây or ¡s unwllling lo relraln lrom smoklng whenevsr requlred for lhe trial proædure
`. Us€ of prescrlptlon drug6 wlthin 3 we€ks prlor to doslng, non-prescriÞtlon drugs wlthln I week prior to doslng sxc€pl
`foÍ vltamlns, minerals and nutrltional supplemsnts
`. Rsce¡v€d any lnvestigationâl drug withln 12 ws€ks pr¡or to the plannsd frst dosing
`. Sub.lâcts who håve tâken part ln strenuous exercis€ within 48 hours prlor to lrst doslng, due to ¡ntorf€rènce with the hepatlc microsomal monooxygênase system. Thê
`lnvestigator ôr Sub-lnv€stlgator will evâluate wheth€r strenuous exercise hâs been undertaken
`. Loss of more than 4OO mL blood ln totål withln the last 12 weeks or more thsn 200 mL blood ln total wlthln the last 4 wêeks prior to first doslng
`. Subjects with a first-d€gr€e
`relâlive w¡th dlabetes mell¡lus
`. Mentâl incâpâc¡ty, unwillingness or language bârriers precludlng adequate understanding or cooperation
`. Possiblllty that the subject wlll not ømply with the p¡otocol
`. Subjêcts who ¡n the oplnlon of the lnvêstigator or Sub-lnvestigator should not pârtlcipate in lhe tr¡âl
`. Subjects wlth known history of either Type 1 or Typ6 2 diabetes mellltus are excludod
`
`Þ Contacts and Locat¡ons
`Please refer to this study by its ClinicalTriâls.gov idenlit¡er: NCT00851773
`
`Localions
`
`United Kingdom
`London SW, Unlted Klngdom, 17 oRE
`
`Sponsors and Collaborators
`
`Novo Nordisk
`
`lnvêstigators
`Study Dlr€ctor: Jan Lynge, MSc, PhD Novo Nordisk
`Þ More lnformat¡on
`
`Additlonal lnformâtlon:
`Clinical Trials at Novo Nordisk $!
`
`No publications provided
`
`Respons¡ble Party:
`
`Public Access 10 Clinicâl Trials, Novo Nord¡sk A./S
`
`Oocument ldr 7E781 D40-AFF0-1 1 ED-9E58-75391 81 FFF26
`onl¡nêNotary.net
`
`I rrIlil[mLililillll]¡llllllllllllll
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`Page 8114
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`MPI EXHIBIT 1014 PAGE 8
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`MPI EXHIBIT 1014 PAGE 8
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 8 of 14
`
`

`

`Cl¡ni€lTriâls.govldonffior: NglqOgSlTZg HlstoruofChsngeg
`olhôr Sludy lD Numbers: NN953&3633, 200&006325-13
`StudyFlretRoo6lvsd: Fèb¡uâry2ã,2009
`LaÊtupdated:
`July 15,2010
`Heallh Aúlhorlty:
`Unlted Klngdom: Môdlclnea ând l'leålthcarè Products Rsgulatory Agency
`CllnicalTrial8.gov procêsÊed thlô rôcord on octob€r 20, 20ll
`
`-#m,#
`
`Dodment ld: 7Ê7BlD40-AFF0-1 lED-9E58-7539181FFF26
`OnllnENotary.n€t
`
`lll¡Lililil¡lt]til¡t
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`Page 9/14
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`MPI EXHIBIT 1014 PAGE 9
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`MPI EXHIBIT 1014 PAGE 9
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 9 of 14
`
`

`

`https://web.archive.org 1web120090911011536/https://clinicaltrials.govlct2lsho@NCT00S5tTT3
`
`Docuñênt ld: 7E?81D40-AFF0-1 IED-9E68-753918'l FFF26
`OnlineNotary.net
`
`ilt ililtüil¡ü ililililililil1r l[]ililullI I lililll lll
`
`Page 10/14
`
`MPI EXHIBIT 1014 PAGE 10
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`MPI EXHIBIT 1014 PAGE 10
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 10 of 14
`
`

`

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`Related stud¡es
`
`Safety, TolerabillÇ, and Profile of Action of Drug in the Body of NN9535 ln Healthy Male Japanese and Caucasian Subiects
`This study is ongoing, but not recru¡t¡ng participants.
`Flrst Recelved; February 25, 2009 Last Updated: August 26, 2009 Hlstorv of changes
`
`Sponsored by: Novo Nordisk
`
`lnfomât¡on prov¡ded by: Novo Nordisk
`
`Cl¡nicallr¡als,gov
`
`ldentifier: NCT00851773
`
`Þ Purpose
`
`NN9535 in healthy male Japãnese and Caucasian subjects.
`
`cond¡t¡on
`
`Healthy
`
`l¡teruention
`
`Drug: NN9535
`Drug: placêbo
`
`Phasê
`
`Phãse I
`
`StudyType: lnteru€nt¡onal
`Study Deslgn: Treatment, Randomized, Double gl¡nd (Subject, lnvestlgâtor), Plscebo Control, ParallelAsslgnment, Sstety Study
`
`NN9535 in Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous lnjecl¡ons.
`
`Further study delails as provided by Novo Nord¡sk:
`
`Primary Oulcome Measures:
`. AdverseeventsITimeFrame:atallscheduledvisils(2-14)followingscreen¡ng][Designatedassafety¡ssue:Yes]
`
`Secondary Outcome Measures:
`. FrequencyofhypoglycaemiceplsodeslTlmeFrame:âtallschedulêdvisils(2-14)follow¡ngscreeninglIDesignatedassafetyissue:Yes]
`. Vital signs (blood preEsure and pulse) [ Time Frame: at all scheduled visits (2 - 1 4) including screening (v¡s¡t 1 ) I I Designated as safety ¡ssuer No ]
`.12-leadECG(electrocardiogram)[TimeFrame:atallscheduledv¡sits(2-14)¡nclud¡ngscr€en¡ng(v¡sit1)][Designatedassafetyissue:Noì
`. HaematotogyITimeFrame:atallscheduledvisits(2-14)includingscreen¡ng(v¡sit1)][Des¡gnatêdassafely¡ssue:Nol
`. B¡ochemistry[T¡meFrameiatallschêduledv¡slts(2-14)includingscreening(visitl)]lÞesignat€dassafety¡ssue:Nol
`. Urinalys¡s I T¡me Frame: at all scheduled visits (2 - 1 4) ¡ncludiñg screening (vis¡t 1 ) ] [ Designâted as safety issuer No ]
`. Calcitonln I Time Frame: at screening (v¡slt 1 ) and ât vislts 2, I and '14 ] [ Des¡gnated as safety issuer No ]
`. Ant¡body developmsnt aga¡nst N9535 [ Tìme Frame: at visits 2 and 1 4 ] [ Des¡gnated as safety issue: No ]
`
`Enrollment:
`84
`Study Starl Date:
`February 2009
`ÊstlmatÊd Sludy Completion Date; August 2009
`Estimated Pr¡mary Completion Date: Augusl 2009 (Flnal data colleclion date for pr¡mary oulcome measure)
`
`Arms
`
`Ass¡gned lntervent¡ons
`
`A: Experimental
`
`Drug: NN9535
`0.'l mg once weekly, s.c. injection
`
`B: Experimental
`
`Drug: NN9535
`0.2 mg once weekly, s,c. iniect¡on
`
`C: Exper¡mental
`
`Drugr NN9535
`0.4 mg once weekly, s.c. ¡nject¡on
`
`D: Experimental
`
`Drug: NN9535
`0.4 mg once weêkly lor 1 week, 0,8 mg once weekly for 7 weeks, s.c. ¡njeclion
`
`Ê: Ëxper¡mental
`
`Drug: NN9535
`0.8 mg once weekly, s.c. injection
`
`F: Experimental
`
`Drug: NN9535
`0.4 m9 oncê week¡y for 1 w€€k, 0.8 mg once weekly for I week, 1.6 mg once weekly for 6 weeks, s.c. injection
`
`G: Experìmêntal
`
`Drug: NN9535
`S.c, inject¡on: 0,4 mg onc€ weekly forl week, 0.8 mg once weekly for 1 week, followed by once weekly injections for 6 weeks. Dose to be
`detêrm¡ned based on safely and tolerab¡l¡ty of previous dose steps.
`
`This dose-arm is opt¡ona¡ and will only be implemented if the 0.8 mg is tolerated but the 1.6 mg ¡s not.
`
`H1: Placebo
`Comparator
`
`Drug: placebo
`0.1 mg once weekly, s.c. injection
`
`Document ld: 7E7Bl D40-AFF0-1
`OnlineNotary.net
`
`f ED-9E58-75391 81 FFF26
`
`ï ilnrililllllllllllllllllllllllllllllll
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`Page 11114
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`MPI EXHIBIT 1014 PAGE 11
`
`MPI EXHIBIT 1014 PAGE 11
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 11 of 14
`
`

`

`H2r Placebo
`Compârator
`
`H3: Plâcèbo
`Comparator
`
`H4: Placebo
`Comparator
`
`H5: Placêbo
`Comparalor
`
`H6; Placebo
`Compârator
`
`H7: Placebo
`Comparator
`
`Drug: plaæbo
`0.2 mg once we€kly, s.c. inject¡on
`
`Drug: placebo
`0.4 mg once weekly, s.c. inigctlon
`
`Drug: plaæbo
`0.4 mg oncê weekly for I week, 0,8 mg once weekly for 7 weeks, s.c. ¡nJect¡on
`
`Drug: plaæbo
`0.8 mg once we€kly, s.c.
`
`injectlon
`
`Drug: plaæbo
`0.4 mg once weekly fot 1 week, 0.8 mg once weekly for I week, 1'6 mg onæ weekly for 6 weeks, s'c iniætion
`
`Drug: placebo
`for 1 we€k, 0.8 mg oncê wêekly for 1 weèk, followed by once w€skly injêctlons
`S.c. injectlon: 0.4 mg oncê we€kly
`determlned based on safêty and tolerability of previous dose step6.
`
`for 6 weeks. Doso to be
`
`Þ etigioirity
`Ages Ellglble lor Sludy:
`Genders Eligible for Study:
`Acc€pts Healthy Volunteers:
`
`Cr¡teria
`
`20 Yea6 to 45 Yeårs
`Male
`No
`
`lnclu6ion Crltsria:
`. For caucasian or Japanese volunts€rs ths
`following applies:
`. lnform€d cons€nt obtalned bêfore âny trial-rêlatsd actlv¡t¡és
`. Body welght between 54 and 90 kg (both lncluslve)
`. Body ma6s index (BMl) between 18,5 and 24 9 kgh2 (bolh inclus¡ve)
`. HbAlc below 6.0 %
`. SubJects who are consldered to be generally healthy based on assessment of medlcâl history physiæl examlnâllon end cllnical lâborâtory data at Gcrsenlng, as judged þy the
`lnvesdgator
`. Subjecls who are sexually actlvê ând have pannef6 who are or could be pregnânt âre wllling and requlred to use a barrler method of contracept¡on (e.9. condom) for the
`duratlon of the study ând for 90 dãys followlng the lâst doss of study medlcatlon
`. Japan€se passpol hold€r, Japanes€-born
`parents, lived outsid€ Japan for 5 ysars or less
`
`Exclusion Crlteria:
`. Any cllniæl laboratory values deviåting from or outslde the laboråtory reference range unless considerêd not to be clinically s¡gn¡licant by the investigator
`. Any abnormal ECG fndings at the screenlng, considered lo bo cl¡n¡cally signficânt by the lnvest¡gâtor
`
`haematologlcal, neurolog¡cal, or psychlatrlc diseases or disorders, conEldêred to be cllnlcally slgnilicant by the lnvestlgator
`. Previous random¡sed In th¡s trial (not âpplicabl€ for sland-by volunteers)
`. Blood pr€ssurs
`in supine posltion at th€ screêning, añer resting for 5 min, and ln the standing posit¡on after stand¡ng fot 1 min, ænsistently outside the ranges 90 - 140 mmHg
`systollc or 40 - 90 mmHg dlâ6tollc
`. Heârt râte in supinê position al the sffeening, after resting for 5 mln, consistently àbove '1 00 beats/min
`. Alcohol intake w¡thln 48 hou¡s prlor lo the scrêenlng and admlssion (exsmin€d by alcohol breath test)
`. H€patitÌs B surfac€ ant¡gen, Hepatit¡s C åntibod¡es or Human lmmunodeñclency Vlrus (HlV) antibodies posit¡ve
`. H¡story of s¡gnificant ållergy or hypersênsitivity
`. Known or suspected allergy lo lrial product or related products
`. H¡story of drug or alcohol abu6ê (alcohol abu6€
`of more than 21 units (U) weekly: One unit of alæhol Êqual6 1l2 p¡nt (approximat€ly 250 mL) of besr or
`is d€tin€d as intaks
`lager, or one glass of wins or Japånese sake, or 1/6 gill (spproxlmâtely 20 mL) of spirits)
`. Subjects who smoke mors thån 1O cigar€ttês, or the equivâlênt, per day or is unwilllng to rêfrain from smoking whenevêr rêquirsd for lhe trial proædu¡ê
`. Use of prescriptlon drugs wlthln 3 woeks prlor to doslng, non-prêscrlption drugs wlthln 1 weêk prior to dosing excepl for vltâmlns, minerals and nutr¡tionâl supplem€nts
`. Rêcs¡vèd any invest¡gational drug withln 12 wækÊ prior to ths planned firôt dosing
`. Subjecls who have taken part ln strenuous exêrcise withln 48 hours prior to first dosing, due to interference w¡lh the hepalic mlcrosomal monooxygenase system. The
`lnv€stigator or Sub-lnvsst¡gator wlll evaluate wheth€r strsnuous €xercise has b6en underlak6n
`. Loss of more than 4OO mL blood in total w¡thin the last 12 weeks or more thân 200 mL blood ln total within the last 4 weeks pr¡or to l¡rsl dosing
`. Subjecls with a flrst-degreê relatlve wlth disbetes msllltus
`. Mentâl incapacìty, unwillingness or language barriers preclud¡ng adequate understanding or cooperalion
`. Possibility that the subject will not comply w¡th thê protocol
`. Subjectswhointheop¡nionofthelnvestlgatororSublnvestigalorshouldnotparticipate¡nth€tr¡al
`. Subjects with known history of êither Type I or Type 2 dìabetes m€llitus arè excluded
`
`Þ Contacts and Locations
`Pleass refer to lhis study by its ClinicalTrials.gov ident¡fier: NCT00851773
`
`Locat¡ons
`
`Unlted K¡ngdom
`London SW Unlted Klngdom, '17 oRE
`
`Sponsors and CollaborâtoE
`Novo NordiEk
`
`lnvesligators
`Sludy DirBctorl Jan Lynge, MSc,PhD Novo Nordisk
`Þ More lnformat¡on
`
`Documênt ldr 7E781 D40-AFF0-f I ED-9E58-75391 It FFF26
`On¡¡neNotary.nêt
`
`] nltilill]llllllllllllllillllllllllll
`
`Page 12114
`
`MPI EXHIBIT 1014 PAGE 12
`
`MPI EXHIBIT 1014 PAGE 12
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 12 of 14
`
`

`

`' Clln¡æ¡Trials at Novo Nordlsk W¡
`
`No publlcstons providod
`
`Rosponslþla Party:
`study lo Numbsrs:
`Study Flrst Roceived:
`Last Updaled:
`ClinicãlTrials.gov ldèntlfþr:
`Health Authorlty:
`
`Novo Nordl6k A,/9 ( Publlc Acc.s6 to clln¡cal Tlals )
`NN953$3633, Eudracï No: 2008-00632t13
`Fèb¡uâry 25, 2009
`August 26, 2009
`NCT00851773 H¡stowoiChanggs
`Un¡ted Klngdom: M.dicins and lleàllhcsre Pþduots RegulatoryAgency
`
`Study plrc€d
`in the following topic catsgotieô:
`Healthy
`
`ClinicalTrlâls.gov processcd thls reco¡d on Septombêr 10, 20Og
`
`frnÞcl HdÈDss&
`Llstår Hìll NâlloÉl Ceîler br Homodlel Cmmunl€lbm, u-s. NâlloMl Llb€ry ol Madiclm,
`u.S. Netloñål lßttutesol Heãlth, u.s. hpalmg!l9[-Hgaltb.&]1um¡É9gic9Ê,
`UjB.0!y. ClnyliSbl. Pdl¡ry, Affiiblllly, Fredom orlnrorufloñrd
`
`#m'.?
`
`ld: TE7Bl D40-AFF0í tED.9E68-75391 81 FFF26
`Docum€nt
`OnlineNotary.net
`
`r lnillilu]ilililililmillllllll
`
`Page 13/14
`
`MPI EXHIBIT 1014 PAGE 13
`
`MPI EXHIBIT 1014 PAGE 13
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 13 of 14
`
`

`

`IURAT ATTACHMENT
`
`A notary public or other officer completing this certificate verifies only the identity of the individual who signed
`the document to which this certificate is attached, and not the truthfulness, accuracy, or validity of that
`document.
`
`STATE OF Virginia
`
`l
`
`COUNTY OF
`
`Arlington
`
`Ì
`
`The foregoing instrument was subscribed and swom before me this date of
`0211912O23 ,by Nathaniol Frank-$Uhite
`
`This notarial act was an online notarization.
`
`CHIRAG PATEL
`ELECTRONIC NOTARY PUBLIC
`COMMONWEALTH OF VIRGINIA
`NOTARY lD: 7679556
`COMISSION EXP: JUNE 30, 2024
`
`(Notary Seal)
`
`e@
`
`Notary's
`
`Registration No.: 7679556
`
`commission Exoiration Date: June 30' 2024
`
`Documênt ld: 7E781 D40-AFF0-l I ED-9E58-75391 81 FFF26
`OnlineNotary.net
`
`r ¡ll]ilililllilillilllllllll llllllllll
`
`Page'14114
`
`MPI EXHIBIT 1014 PAGE 14
`
`MPI EXHIBIT 1014 PAGE 14
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1014, p. 14 of 14
`
`