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`AFFIDAVIT OF NATHANIEL E FRANK-WHITE
`
`1. 1 am a Records Request Processor at the Internet Archive. I make this declaration
`of my own personal knowJedge.
`
`2. The Internet Arcbive is a website that provides access to a digital library oflntemet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and tbe general public. Tile Internet
`Archive has partnered with and receives support from various institutions, •
`including the Library of Congress.
`
`3. The Internet Archive bas created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). lf archived records for a URL are
`available, the visitor will be presented witb a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink's URL with the
`closest available date to the initial file containing the byperlink.
`
`4. The archived data made viewable and browsable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`5. The Internet Archive assigns a URL on its site to the arcbivcd files in the format
`http://web.archive.org/web/[Year in yyyy]lMonth in mm]lDay in dd][Time code in
`bh:mm:ss]/[Arcbived URL] aka an "extended URL" . Thus, the extended URL
`http://web.archive.org/web/I9970126045828/http://www.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 (1997/01/26 at 04:58:28). The date indicated by an extended URL applies
`to a preserved instance of a file for a given URL, but not necessarily to any other
`files linked therein. Thus, in the case of a page constituted by a primary HTML file
`and other separate files (e.g., files with images, audio, muJtimedia, design
`elements, or other embedded content) linked within that primary HTML file, the
`primary HTML file and the other files will each have their own respective extended
`URLs and may not have been archived on the same dates.
`
`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.
`
`Dooument I~: 7'E'7B1 D4(1-AFF0-11ED-9E5~75S9181 FFF26
`OnflnuNot,uy .net
`
`1111111111111m 1111111111111111111111111111111111111m111
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`Page 1/14
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`MPI EXHIBIT 1014 PAGE 1
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`MPI EXHIBIT 1014 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0001
`
`

`

`1-ARCHlVE
`w
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`~ 1111
`
`archlve.org
`
`7.
`
`l declare under penalty of perjury that the foregoing is true and co1Tect.
`
`DATE: _0_2_l_1_gl_ 2_0_2_3 _ _ _ _
`
`Nathaniel EFrank-White
`
`Document Notarizeq using a Live Audio-Video Connection
`
`CHIRAG PATEL
`ELECTRONIC NOTARY PUBLIC
`COMMONWEALTH OF VIRGINIA
`NOTARY ID: 7679556
`COMISSION EXP: JUNE 30, 2024
`
`Please soe attached
`All Purpose
`Jurat form
`for additional
`Notary Events
`
`Oocum•nl Id: 7E7B1040.CAFF0-11E0-9E58-7539181FFF28
`Oiih~aN01:ary.r111t
`
`111111111111111111111111111111111111111111
`
`Page2/14
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`MPI EXHIBIT 1014 PAGE 2
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`MPI EXHIBIT 1014 PAGE 2
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0002
`
`
`

`

`EXHIBIT A
`
`Document Id: 7E7B 1 D40-Af F0• 11 ED-9E5&. 7539181 FFF26
`OnllneNotar;,nef
`
`111111111 IIIIIIIIHIIUIIIIIIUIUIIHUIIIIUIIIII fl
`
`Page 3/14
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`MPI EXHIBIT 1014 PAGE 3
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`MPI EXHIBIT 1014 PAGE 3
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0003
`
`

`

`https://web.archive.org/web/20111227072635/https://clinicaltrials.gov /ct2/show/NCT00851773
`
`Documenl Ide 7E7B 1O40·AFF0· 11E0-9E58-7539181 FFP26
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`lll Ull lllllll!I IIIRIRIIII II UIIIIIIIUHI 1811111 U
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`Paga 4/14
`
`MPI EXHIBIT 1014 PAGE 4
`
`MPI EXHIBIT 1014 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0004
`
`

`

`~ ups:llclinicaltrials.gov/c12/show/NCT00851773
`
`1.Q.£i1Rll!W
`U 3ep2009· 16Ap,2021
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`ClinicalTrials.gov
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`A Hrvic• d the U.S. Hltlonal lnltit\An of liullh
`
`No Study Results Posted
`
`SEP
`►
`2013
`
`tl2lu WWI
`
`Safety, Tolerability, and Profile of Action of Drug In the Body of NN9535 In Healthy Male Japanese and Caucasian Subjects
`
`This study has been completed.
`
`Information provided by Novo Nordisk
`Study NCT00851773
`First Received: February 25. 2009 Last Updated: July 15, 2010
`t!ifilQ._ry...21.lJliwg~
`
`No Study Results Posted on CllnlcalTrlals.gov for this Study
`
`About study Results Rell2J1lna on cnn1ca1Ici•I• aoy
`
`Study Status: This study has been completed.
`
`Study Completion Date: October 2009
`
`Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
`
`~
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`Oowmonl Id: 7E7B1D40,AFF0,11EO-9E58-7539181FFF26
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`
`Page 5/14
`
`MPI EXHIBIT 1014 PAGE 5
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`MPI EXHIBIT 1014 PAGE 5
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0005
`
`(cid:173)
`

`

`https://web.archive.org/web/20111022103538/https://clinicaltrials.gov/ct2/show/NCT00851773
`
`Document Id: 7E781O40-AFF0·11E0-9E58-7539t81FFf26
`OnlineNotury,1111
`
`m111111111111mlllHIIIIIIIIIUlllllfllllllllllllmll
`
`Page6/14
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`MPI EXHIBIT 1014 PAGE 6
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`MPI EXHIBIT 1014 PAGE 6
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`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0006
`
`

`

`11 §] SEP
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`;;.;.;.;.....;c:=-==c...=:..:.;.;.;"--.;....;..;.;;.;____;_ _ _ _ _ _ __ _ _ __ _ _ _ __ _ _ _ _ _ _ _,
`[hnps:llclinicaltrials.govlct21showlNCT00851773
`
`◄
`
`DEC
`►
`2012
`.l:l2m!: ~
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`II Sfp2009 - 16AJV202l
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`Full Text View
`
`Safety, Tolerability, and Profile of Action of Drug In the Body of NN9535 In Healthy Male Japanese and Caucasian Subjects
`
`This study has been completed.
`
`First Received on February 25. 2009. Last Updated on July 15. 2010 l:1W2!Y~g~
`
`Sponsor: Novo Nordisk
`
`lnfonnaUon provided by: Novo Nordisk
`
`CllnlcalTrlals.gov ldenllller: NCT00851773
`
`► Purpose
`
`This trial Is conducted In Europe. The aim of this clinical trial Is to assess and compare the safety and tolerability. as assessed by adverse events after multiple subcutaneous doses of
`NN9535 in healthy male Japanese and Caucasian subjects.
`
`~
`
`Healthy
`
`la1ir'.ieoti2D
`
`Drug: NN9535
`Drug: placebo
`
`fhlli
`Phase I
`
`Study Type:
`Study Design:
`
`lnterventlonal
`Allocation: Randomized
`Endpoint Classification: Safety Study
`Intervention Model: Parallel Assignment
`Masking: Double Blind (Subject, Investigator)
`Primary Purpose: Treatment
`Official rrtle: A Randomised. Double Blind. Placebo-controlled, Parallel-group, Multiple Doses, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokineti~ Profiles of
`NN9535 In Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous lnjecllons.
`
`Further study det ails as provided by Novo Nordisk:
`
`Primary Outcome Measures:
`• Adverse events I Time Frame: at all scheduled visits (2 • 14) following screening I [ Designated as safety Issue: Yes]
`
`Secondary Outcome Measures:
`, Frequency of hypoglycaemic episodes I Time Frame: at all scheduled visits (2 - 14) follovAng screening) [ Designated as safety issue: Yes ]
`• Vital signs (blood pressure and pulse) [ Time Frame: at all scheduled visits (2 - 14) Including screening (visit 1)] [ Designated as safely issue: No j
`• 12-lead ECG (electrocardiogram) [ Time Frame: at all scheduled visits (2 -14) Including screening (vlslt 1) I I Designated as safety issue: No j
`• Haematology [ Time Frame: at all scheduled visits (2 • 14) Including screening (visit 1) ] I Designated as safety Issue: No]
`• Biochemistry [ Time Frame: at all scheduled visits (2-14) including screening (visit 1) I I Designated as safety Issue: No)
`• Urinalysis [ Time Frame: at all scheduled visits (2 • 14) including screening (visit 1)) I Designated as safety Issue: No ]
`• Calcitonin [ Time Frame: at screening (visit 1) and at visits 2, 9 and 14] ( Designated as safety Issue: No]
`• Antibody development against N9535 [ Time Frame: at visits 2 and 14 ] [ Designated as safety Issue: No I
`
`Enrollment:
`Study Sta~ Date:
`Study Completion Date:
`Primary Completion Date:
`
`84
`February 2009
`October 2009
`October 2009 (Final data collection dale for primary oulcome measure)
`
`Ar.mi
`
`A: Experimental
`Intervention: Drug:
`NN9535
`
`8: Experimental
`lntervenlion: Drug:
`NN9535
`
`C: Experimental
`Intervention: Drug:
`NN9535
`
`D: Experimental
`Intervention: Drug:
`NN9535
`
`E: Experimental
`Intervention: Drug:
`NN9535
`
`F1: Placebo Comparator
`Intervention: Drug:
`placebo
`-- -·
`
`-
`
`Alli9D!ild la!ell:'.oatioos
`
`Drug: NN9535
`0.1 mg once weekly, s.c. injection
`
`Drug: NN9535
`0.2 mg once weekly, s.c. injection
`
`Drug: NN9535
`0.4 mg once weekly, s.c. ln)ection
`
`Drug: NN9535
`0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. Injection
`
`Drug: NN9535
`0.4 mg once weekly for 1 week. 0.8 mg once weekly for 1 week. 1.2 mg once weekly for 6 weeks, s.c. Injection
`
`Drug: placebo
`0.1 mg once weekly, s.c. Injection
`
`-
`
`Document Id: 7E7B tc40-AFF0-11E0-9ES8-7539181 FFF26
`OnlineNolary.net
`
`II llllill lllllllllllllllllllllllllilllllll
`
`Page 7/14
`
`MPI EXHIBIT 1014 PAGE 7
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`MPI EXHIBIT 1014 PAGE 7
`
`Apotex v. Novo - IPR2024-00631 Petitioner Apotex
`Exhibit 1014-0007
`
`

`

`t-t: ~,aceoo t,;omparalor
`Intervention: Drug:
`placebo
`
`F3: Placebo Comparator
`Intervention: Drug:
`placebo
`
`F4: Placebo Comparator
`Intervention: Drug:
`placebo
`
`F5: Placebo Comparator
`lnlerventlon: Drug:
`placebo
`
`urug: p1aoeoo
`0.2 mg once weekly, s.c. Injection
`
`Drug: placebo
`0.4 mg once weekly, s.c. Injection
`
`Drug: placebo
`0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks. s.c. injection
`
`Drug: placebo
`0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly Injections for 6 weeks, s.c.
`Injection
`
`► Eligibility
`
`20 Years 10 45 Years
`Ages Eligible for Study:
`Genders Eligible for Study:
`Male
`Accepls Heallhy Volunteers: No
`
`Criteria
`Inclusion Criteria:
`
`• For Caucasian or Japanese volunteers lhe following applies:
`• Informed consent obtained before any trial-related acilvllles
`• Body weight between 54 and 90 kg {bolh Inclusive)
`• Body mass Index (BMI) between 18.5 and 24.9 kg/m2 (bolh Inclusive)
`• HbA le below 6.0 %
`, Subjects who are considered 10 be generally heallhy based on assessment of medical history, physical examination and clinical laboratory data al screening, as judged by lhe
`lnvesUgelor
`, Subjects who are sexually active and have partners who are or could be pregnanl a,e willing and required to use a barrlar melhod of conlraceplion (e.g. condom) for lhe
`duration of lhe study and for 90 days following lhe lasl dose of study medication
`• Japanese passport holder. Japanese-born parents, lived outside Japan for 5 years or less
`
`Exclusion Crlter1a:
`• Any clinical laboratory values deviating from or outside the laboratory reference range unless considered not lo be clinically significant by lhe lnvesllgalor
`• Any abnormal ECG findings at the screening, consldeied to be clinically slgnfficanl by the Investigator
`• Presence or history of diabetes, cancer or any clinically significant cardiac, resptralory, metabolic, renal. hepallc. gas1roin1eslinal, endocrinological, dermatological, venereal,
`haematological, neurological, or psychiatric diseases or disorders, considered l.o be cllnlcally significant by the lnves1Iga1or
`• Previous randomised In lhis trial (nol applicable for stand-by volunteers)
`• Blood pressure in supine position at the screening, atter resUng for 5 min, and in l he standing position after slandlng for 1 min. consistently outside lhe ranges 90 • 140 mmHg
`systolic or 40 • 90 mmHg diastolic
`• Hean rate in supine position at the screening, after resting for 5 min, conslslenlly above 100 beats/min
`• Alcohol Intake wllhln 48 hours prior to the screening and admission (examined by alcohol breath test)
`• Hepatitis B suTface anllgen, Hepalllls C anllbodles or Human Immunodeficiency Virus (HIV) antibodies positive
`• History of slgnlflcanl allergy or hypersensitivity
`• Known or suspected allergy lo trial product or related pioducts
`, History of drug or alcohol abuse (alcohol abuse is defined as l nlake of more lhan 21 units (U) weekly: One unit of alcohol equals 112 pint (approximately 250 mL) of bee, or
`lager, or one glass of wine OT Japanese sake. or 116 gill (approximalely 20 mL) of spirits)
`• Sublecls who smoke moie lhan 10 cigareltes, or the equivalent, per day or is unwilling to refrain from smoking whenever required for lhe trial procedure
`, Use of prescrtpllon drugs within 3 weeks prior to dosing, non-prescrtpllon diugs Within 1 week prtor to dosing except for vitamins. minerals and nulrlllonal supplements
`
`• Received any investigational drug within 12 weeks prio, 10 the planned first dosing
`• Subjects who have taken part In strenuous exercise within 48 hours prior 10 firs! dosing. due lo Interference with lhe hepatic microsomal monooxygenase system. The
`Investigator or Sub-Investigator will evaluate whether strenuous exercise hes been underlaken
`• Loss of more than 400 ml blood In lolal within lhe lasl 12 weeks or more than 200 mL blood In lotal within lhe lasl 4 weeks prior to firs! dosing
`• Subjects wllh a first-degree relalive with diabetes mellilus
`• Mental incapaci1y, unwillingness or language barriers precluding adequate understanding or cooperation
`• Possibllily lhat lhe subject will nol comply wllh lhe protocol
`• Subjects who in the opinion of the Investigator or Sub-lnvesllgetor should nol participate In the !rial
`• Subjects wllh known history of ellher Type 1 or Type 2 diabetes mellltus are excluded
`
`► Contacts and Locations
`
`Please refer to this study by lls CiinlcalTrials.gov Identifier: NCT00851773
`
`Locations
`
`Un ited Kingdom
`London SW, Unlled Kingdom, 17 ORE
`
`Sponsors and Collaborators
`
`Novo Nordisk
`
`Investigators
`Study Director: Jan Lynge, MSc, PhD Novo Nordisk
`
`► More Information
`
`Additional lnformallon:
`Clinic.al Trials at Novo Nordisk ~
`
`No publications provided
`
`Responsible Party:
`
`Public Access 10 Clinical Trials, Novo Nordisk IVS
`
`Document Ide 7E7B1D40-AFF0-11E0-9E58-7539181FFF26
`OnlineNotiuy.net
`
`111111111111111111111111111111111111111111
`
`Page 8/14
`
`MPI EXHIBIT 1014 PAGE 8
`
`MPI EXHIBIT 1014 PAGE 8
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0008
`
`

`

`ClinicalTrials.gov Identifier:
`Other Study ID Numbers:
`Study First Received:
`Lost Updated:
`Health Authority:
`
`l:lw2!Y~gw;
`NCT00851773
`NN9535-3633, 2008--006325-13
`February 25. 2009
`July 15, 2010
`United Kingdom: M edicines and Healthcare Products Regulatory Agency
`
`ClinicelTrlals.gov J)focessed this record on October 20, 2011
`
`CooJa,d Hok> Dnsk
`Lisle! Hill NaJiOl@I C@otftl lPf 8i9!l'.Ktdie:tl Comrounl!:iUlooa. U $ Nalimtat ltl>rary~
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`Ooa,ment Id: 7E7B1040-AFF0-11E0-9E58-7539181 FFF26
`OnlineNolary.net
`
`II llll 111111111111111 ll1111111111111111111
`
`Page 9/14
`
`MPI EXHIBIT 1014 PAGE 9
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`MPI EXHIBIT 1014 PAGE 9
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0009
`
`

`

`https:/ /web.archive.org/web/20090911011536/https://clinicaltrials.gov /ct2/show/NCT00851773
`
`Dowment Id, 7E18104Q•AFF0-1 iE.0·9E.5S.76391BiFFF26
`OnlinoN01ar;tn8I
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`E RHIIII IIIII IIJHIUIIIIII IUIHIIIIIII IIOIIIHIU
`
`Page 10/14
`
`MPI EXHIBIT 1014 PAGE 10
`
`MPI EXHIBIT 1014 PAGE 10
`
`Apotex v. Novo - IPR2024-00631 Petitioner Apotex
`Exhibit 1014-0010
`
`

`

`I ~ "11
`"-""'=====c=.;..;.:.;;;;..c::c:.=:..:.:_.:..:.... _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___,
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`
`OCT
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`Full Text View
`
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`
`Safety, Tolerability, and Profile of Action of Drug In the Body of NN9535 In Healthy Male Japanese and Caucasian Subjects
`
`This study is ongoing, but not recruiting participants.
`
`First Received: February 25, 2009 Last Updated: August 26, 2009 J:lW2_ry..21..Qmag!1Ji
`
`Sponsored by: Novo Nordisk
`
`Information provided by: Novo Nordisk
`
`CllnlcalTrlals.gov Identifier: NCT00851773
`
`► Purpose
`
`This trial is conducted in Europe, The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subculaneous doses of
`NN9535 In healthy male Japanese and Caucasian subjects.
`
`!.2nl!illQ.n
`
`Healthy
`
`lnt~ll:'.tD1iQD
`
`Drug: NN9535
`Drug: placebo
`
`fMli
`Phase I
`
`lntervenUonal
`Study Type:
`Study Design: Treatment , Randomized, Double Blind (Subject. Investigator), Placebo Control, Parallel Asslgnmenl, Safely Study
`
`Official Tille:
`
`A Randomised. Double Blind. Placebo-controlled. Parallel-group, Multiple Doses. Dose Escalation Sludy to Assess lhe Safety, Tolerability, and Pharmacokinetics Profiles of
`NN9535 In Healthy Male Japanese and Caucasian Subjects After Weekly Subcutaneous Injections.
`
`Further study details as provided by Novo Nordisk:
`
`Primary Outcome Measures:
`• Adverse events ( Tlme Frame: at all scheduled visits (2 - 14) following screening) ( Designaled as safety Issue: Yes )
`
`Secondary Outcome Measures:
`• Frequency of hypoglycaemic episodes ( Time Frame: at all scheduled visils (2 - 14) following screening J ( Designaled as safety Issue: Yes J
`• Vital signs (blood pressure and pulse) I Time Frame: at all scheduled visits (2 • 14) including screening (visil 1) J ( Designaled as safety issue: No)
`• 12~ead ECG (electrocardiogram) ( lime Frame: at all scheduled visits (2 -14) including screening (visit 1) ) [ Designated as safely issue: No)
`• Haemalology ( Tlme Frame: at all scheduled visits (2 - 14) including screening (visit 1) J ( Designated as safety issue: No J
`• Biochemistry [ Time Frame: at all scheduled visits (2 - 14) including screening (vlsll 1) I I Oesignated as safety issue: No J
`• Urinalysis ( Time Frame: at all scheduled visits (2 - 14) including screening (visit 1)) I Designated as safety Issue: No)
`• Colcitonin ( lime Frame: at screening (visit 1) and at visits 2, 9 and 14) [ Designaled as safety Issue: No J
`• Antibody development against N9535 [ lime Frame: at vi sits 2 and 14) ( Designated as safety issue: No)
`
`84
`Enrollment:
`February 2009
`Study Start Date:
`August 2009
`Estimated Sludy Completion Date:
`Eslimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
`
`&ll1li
`
`A: Experimental
`
`rul.Jgofi:s;t ID1~aQD11Qll~
`
`Drug: NN953S
`0.1 mg once weekly, s.c. injection
`
`B: Experimental
`
`Drug: NN9535
`0.2 mg once weekly, s.c. Injection
`
`C: Experimental
`
`Drug: NN9535
`0.4 mg once weekly, s.c. injection
`
`D: Experimental
`
`Drug: NN9535
`0.4 mg once weekly for 1 week, 0,8 mg once weekly for 7 weeks. s.c. injection
`
`E: Experimental
`
`Drug: NN9535
`0.8 mg once weekly, s.c. injection
`
`F: Experimental
`
`Drug: NN9535
`0.4 mg once weekly fo, 1 week, 0.8 mg once weekly for 1 week, 1.6 mg once weekly for 6 weeks, s.c. injection
`
`G: Experimental
`
`Drug: N N9535
`
`S.c. injection: 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by once weekly injections for 6 weeks. Dose to be
`determined based on safety and tolerability of previous dose steps.
`
`This dose-arm is optional and will only be Implemented if the 0.8 mg is tolerated but the 1.6 mg is not.
`
`H1: Placebo
`Comparator
`
`Drug: placebo
`0.1 mg once weekly, s.c. injection
`
`Doet1men1 Id: 7E781040-AFF0-1 t ED-9E58-7539181FFF26
`OnlineNotary .n8t
`
`II llllllllllllllllllll 11111111111111111111
`
`Page 11114
`
`MPI EXHIBIT 1014 PAGE 11
`
`MPI EXHIBIT 1014 PAGE 11
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0011
`
`◄
`

`

`H2: Placebo
`Comparalor
`
`H3: Placebo
`Comparator
`
`H4: Placebo
`Comparator
`
`HS: Placebo
`Compara1or
`
`H6: Placebo
`Comparator
`
`H7: Placebo
`Comparalor
`
`Drug: placebo
`0.2 mg once weekly. s.c. Injection
`
`Drug: placebo
`0.4 mg once weekly, s.c. injection
`
`Drug: placebo
`0.4 mg once weekly for 1 week, 0,8 mg once weekly for 7 weeks, s.c. Injection
`
`Drug: placebo
`0.8 mg once weekly, s.c. Injection
`
`Drug: placebo
`0.4 mg once weekly for 1 week. 0.8 mg once weekly for 1 week, 1.6 mg once weekly for 6 weeks. s.c. lnjec1ion
`
`Drug: placebo
`S.c. lnjecllon: 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week. followed by once weekly lnJeclions for 6 weeks. Dose to be
`delermlned based on safety and lolerabllily of previous dose sleps.
`
`► Eligibility
`
`20 Years 10 45 Years
`Ages Eligible for Sludy:
`Genders Eligible for Study:
`Male
`Accepts Heallhy Volunleers: No
`
`Criteria
`
`Inclusion Criteria:
`• For Caucasian or Japanese volunteers the following applies:
`, Informed consent obtained before any trial-related acllvltles
`, Body weight between 54 and 90 kg (bolh Inclusive)
`• Body mass Index (BMI) between 18.5 and 24.9 kgl m2 (bolh Inclusive)
`
`• HbA1cbelow6.0 %
`, Subjecls who are considered to be generally heallhy based on assessmenl of medical history, physical examlnailon and clinical laboratory dala al screening, as Judged by lhe
`Investigator
`• Subjects who are sexually aclive and have partners who are or could be pregnant are willing and required to use a barr1er method of contraception (e.g. condom) for lhe
`duration of the study and for 90 days following the lasl dose of study medlcaUon
`• Japanese passpon holder. Japanese-born paren1s, lived outside Japan for 5 years or loss
`
`Exclusion Criteria:
`, Any clinical laboratory values deviating r,om or oulslde the laboratory reference range unless considered nol lo be clinically signlficenl by the lnvesligator
`• Any abnormal ECG findings al !he screening, considered to be clinically slgnificanl by lhe Investigator
`• Presence or history or diabetes, cancer or eny cllnlcally significant cardiac, resplralory, metabolic, renal, hepatic, gastroinlestlnal. endocrlnologlcal, derma1ological, venereal,
`haemalologlcal, neurological, or psychiatric diseases or disorders, considered to be clinically significanl by Iha Investigator
`• Previous randomised in this llial (not applicable ror stand-by volunteers)
`, Blood pressure In supine posttlon at the screening, after resting for 5 min, and in lhe slanding position after standing for 1 min. consistenlly oulslde the ranges 90 -140 mmHg
`systolic or 40 - 90 mmHg diastolic
`, Heart rale In supine position al lhe screening. after resling for 5 min, consistently above 100 beats/min
`, Alcohol Intake within 48 hours prior to the screening and admission (examined by alcohol breath lest)
`• Hepatitis B surface antigen, Hepatilis C anlibodies or Human Immunodeficiency Virus (HIV) anlibodies posilive
`• History of significant allergy or hypersensilivily
`• Known or suspecled allergy to trlal product or related products
`• Hlslory or drug or alcohol abuse (alcohol abuse is defined as inlake of more than 21 units (U) weekly: One unit of alcohol equals 1/2 pinl (approximately 250 mL) of beer or
`lager, or one glass of wine or Japanese sake, or 1/6 gill (spproximslely 20 ml) of splrils)
`, Subjects who smoke more than 10 cigarettes, or the equivalent per day or is unwilling lo refrain from smoking whenever required ror lhe llial procedure
`, Use of prescriplion drugs wilhln 3 weeks prior to dosing, non-prescrlpllon drugs wilhln 1 week prior to dosing except for vilamlns, minerals and nulllllonal supplemenls
`
`, Received any lnvesligational drug wilhln 12 weeks prior to the planned first dosing
`• Subjects who have taken part in strenuous exercise within 48 hours prior to first dosing, due to Interference with the hepatic microsomal monooxygenase system. The
`Investigator or Sub-Investigator will evaluate whether sllenuous exercise has been undertaken
`• Loss of more than 400 ml blood In lolal within the last 12 weeks or more than 200 ml blood in tolal within the last 4 weeks prior to first dosing
`
`• SubJecls with a first-degree relative vAlh dlabeles mellllus
`• Mental Incapacity, unwillingness or language barriers precluding adequale understanding or cooperallon
`• Possibllily that lhe subjecl will nol comply with 1he protocol
`• Subjects who in the opinion of the Investigator or Sub-lnvesligalor should not participale in the trial
`• Subjecls wilh known hlslory or eilher Type 1 or Type 2 diabeles mellitus are excluded
`
`► Contacts and Locations
`
`Please refer 10 this sludy by its ClinicalTrlals.gov idenlifier: NCT00851773
`
`Locations
`
`United Kingdom
`London SW, United Kingdom. 17 ORE
`
`Sponsors and Collaborators
`Novo Nordisk
`
`lnvesllgators
`Study Director: Jan Lynge, MSc.PhD Novo Nordisk
`
`► More Information
`
`Oocument Id: 7E781040-AFF0-11ED-9E58-7539181FFF26
`OnlinoNolary.not
`
`11 ■1■1111111111111111111111111111111111111
`
`Page 12/14
`
`MPI EXHIBIT 1014 PAGE 12
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`MPI EXHIBIT 1014 PAGE 12
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0012
`
`

`

`cunIca1 Trials at Novo Nordisk ~
`
`No publications provided
`
`Responsible Party:
`Study ID Numbers:
`Study Firs! Received:
`Last Updated:
`CllnlcalTrials.gov Identifier:
`Health Authority:
`
`Novo Nordisk A/S ( Public Aocess lo Clinical Trials )
`NN9535-3633, EudraCT No: 2008,006325-13
`February 25, 2009
`August 26, 2009
`NCT00851773 Histo[Y~Qil
`United Kingdom: Medicines and Heallhcare Products Regulalory Agency
`
`Study placed in the following topic categories:
`Healthy
`
`ClinicalTrials.gov processed this record on September 10, 2009
`
`~
`LIMer Hil Nat,ona•CtnuwfOf BtomotficaJComm,mkiiUIQQS ~
`lJ s NaJiooal tost 1u1os g tte<11lb- u s 0!leauroent 8t ttoatn & Hunmn SorYfc9&(cid:173)
`~9D¥- CWYD9lll. ~Y. ~Y- Fmodom o1 101orma1120 Act
`
`Doa,mcnt Id: 7E781D40.AFF0· 11EO·9E58-7539181FFF26
`OnlinoNotaty.nel
`
`111111111111111111111111111111111111111111
`
`Page 13/14
`
`MPI EXHIBIT 1014 PAGE 13
`
`MPI EXHIBIT 1014 PAGE 13
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0013
`
`(cid:173)
`

`

`JURAT 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
`
`Arlington
`COUNTY OF
`----=----- ---
`
`The foregoing instrument was subscribed and sworn before me this date of
`02/19/2023
`, by Nathaniel Frank-White
`
`This notarial act was an online notarization.
`
`CHIRAG PATEL
`ELECTRONIC NOTARY PUBLIC
`COMMONWEAL TH OF VIRGINIA
`NOTARY 10: 7679556
`COMISSION EXP: JUNE 30, 2024
`
`(Notary Seal)
`
`Notary's Signature ___ ~....:~~ - - - - - - - - -- - - - - - - -
`
`7679556
`. N
`.
`eg1Strat10n o.: _____________ ________ _
`R
`
`. D t June 30, 2024
`.
`. E
`.
`omrmss10n xpiration a e:. ____ _
`C
`
`Document Id; 7E781040-AFF0-11ED-9E58-7539181FFF26
`OnlineNotary .nel
`
`11 Ill lllllllllllll I 11111111111111111111111
`
`Page 14/14
`
`MPI EXHIBIT 1014 PAGE 14
`
`MPI EXHIBIT 1014 PAGE 14
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1014-0014
`
`