UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`DR. REDDY’S LABORATORIES, INC.
`and
`DR. REDDY’S LABORATORIES, LTD.,
`
`Petitioners,
`v.
`NOVO NORDISK A/S,
`Patent Owner
`
`
`U.S. Patent No. 10,335,462 to Jensen
`Issue Date: July 2, 2019
`Title: Use Of Long-Acting Glp-1 Peptides
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`
`
`Inter Partes Review No. IPR2024-00009
`U.S. Patent No. 10,335,462
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`PETITIONER UPDATED EXHIBIT LIST
`(As of March 29, 2024)
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`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`DR. REDDY’S LABORATORIES, INC.
`and
`DR. REDDY’S LABORATORIES, LTD.,
`
`Petitioners,
`v.
`NOVO NORDISK A/S,
`Patent Owner
`
`
`U.S. Patent No. 10,335,462 to Jensen
`Issue Date: July 2, 2019
`Title: Use Of Long-Acting Glp-1 Peptides
`
`
`
`
`
`
`Inter Partes Review No. IPR2024-00009
`U.S. Patent No. 10,335,462
`
`
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`PETITIONER UPDATED EXHIBIT LIST
`(As of March 29, 2024)
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`UPDATED EXHIBIT LIST
`
`EXHIBIT
`1001
`
`DESCRIPTION
`U.S. Patent No. 10,335,462
`
`1002
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`1003
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`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`Prosecution history excerpts for U.S. Patent No. 10,335,462
`
`Declaration of John Bantle, MD
`
`CV of John Bantle, MD
`
`Declaration of William J. Jusko, Ph.D.
`
`CV of William J. Jusko, Ph.D.
`
`Declaration of Paul Dalby, Ph.D.
`
`CV of Paul Dalby, Ph.D.
`
`Intentionally Left Blank
`
`Intentionally Left Blank
`
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`
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`
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`
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`
`Clinical Trial No. NCT00851773
`
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`
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`
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`
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`
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`
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`
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`
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`
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`
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`DESCRIPTION
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`
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`
`Drucker, The Incretin System: Glucagon-Like Peptide-1 Receptor
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`368 LANCET 1696 (2006)
`
`Glaesner, Engineering and Characterization of the Long-Acting
`Glucagon-Like Peptide-1 Analogue LY2189265, an Fc Fusion
`Protein, 26 DIABETES/METABOLISM RSCH. & REV. 287
`(2010)
`
`HARRISON’S PRINCIPLES OF INTERNAL MED., Chapter 338
`(Fauci et al. eds. 17th ed. 2008)
`
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`
`Holst, Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl
`Peptidase IV in the Treatment of Type 2 Diabetes Mellitus, 4
`CURRENT OP. IN PHARMACOLOGY 589 (2004)
`
`Jimenez-Solem, Dulaglutide, a Long-Acting GLP-1 Analog Fused
`with an Fc Antibody Fragment for the Potential Treatment of Type 2
`Diabetes, 12 CURRENT OP. IN MOLECULAR THERAPEUTICS
`790 (2010)
`
`Kim, Effects of Once-Weekly Dosing of a Long-Acting Release
`Formulation of Exenatide on Glucose Control and Body Weight in
`Subjects with Type 2 Diabetes, 30 DIABETES CARE 1487 (2007)
`
`2
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`
`
`EXHIBIT
`1031
`
`DESCRIPTION
`Knudsen, GLP-1 Derivatives as Novel Compounds for the
`Treatment of Type 2 Diabetes: Selection of NN2211 for Clinical
`Development, 26 DRUGS OF THE FUTURE 677 (2001)
`
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`
`Knudsen, Glucagon-like Peptide-1: The Basis of a New Class of
`Treatment for Type 2 Diabetes, 47 J. MED. CHEMISTRY 4128
`(2004)
`
`Knudsen, Liraglutide, a GLP-1 Analogue to Treat Diabetes, in
`ANALOGUE-BASED DRUG DISCOVERY II (Fischer & Ganellin
`eds. 2010)
`
`U.S. Patent No. 6,268,343 (“Knudsen patent”)
`
`Lund, Emerging GLP-1 Receptor Agonists, 16 EXPERT OP. ON
`EMERGING DRUGS 607 (2011)
`
`1036 Mojsov, Insulinotropin: Glucagon-like Peptide I (7-37) Co- encoded
`in the Glucagon Gene is a Potent Simulator of Insulin Release in the
`Perfused Rat Pancreas, 79 J. CLINICAL INVESTIGATION 616
`(1987)
`
`1037
`
`1038
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`
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`
`Nielsen, Pharmacology of Exenatide (Synthetic Exendin-4): A
`Potential Therapeutic for Improved Glycemic Control of Type 2
`Diabetes, 117 REGUL. PEPTIDES 77 (2004)
`
`Seino, Dose-Dependent Improvement in Glycemia with Once-Daily
`Liraglutide without Hypoglycemia or Weight Gain: A Double-
`Blind, Randomized, Controlled Trial in Japanese Patients with Type
`2 Diabetes, 81 DIABETES RSCH. & CLINICAL PRACTICE 161
`(2008)
`
`Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)
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`Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21
`INT’L DIABETES MONITOR 1 (2009)
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`1041 WO 03/002136
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`1042 WO 91/11457
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`3
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`EXHIBIT
`1043
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`DESCRIPTION
`U.S. Patent App. Pub. 2004/0102486
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`1044
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`1045
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`1046
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`1047
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`1048
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`1049
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`1050
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`1051
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`Rohatagi, Model-Based Development of a PPARγ Agonist,
`Rivoglitazone, to Aid Dose Selection and Optimize Clinical Trial
`Designs, 48 J. CLINICAL PHARMACOLOGY 1420 (2008)
`
`Shargel, APPLIED BIOPHARMACEUTICS &
`PHARMACOKINETICS (5th ed. 2005)
`
`Yun, Pharmacokinetic and Pharmacodynamic Modelling of the
`Effects of Glimepiride on Insulin Secretion and Glucose Lowering in
`Healthy Humans, 31 J. CLINICAL PHARMACY &
`THERAPEUTICS 469 (2006)
`
`Tamimi, Drug Development: From Concept to Marketing!, 113
`NEPHRON CLINICAL PRACTICE c125 (2009)
`
`FDA Guidance for Industry, Exposure-Response Relationships -
`Study Design, Data, Analysis, and Regulatory Applications (Apr.
`2003)
`
`International Conference on Harmonisation; Dose-Response
`Information to Support Drug Registration; Guideline; Availability,
`59 Fed. Reg. 55972 (Nov. 9, 1994) (“ICH 1994”)
`
`Garber, Efficacy of Metformin in Type II Diabetes: Results of a
`Double-Blind, Placebo-Controlled, Dose-Response Trial, 102 AM.
`J. MED. 491 (1997)
`
`Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in
`Diabetes Mellitus, 47(7) CLINICAL PHARMACOKINETICS 417
`(2008)
`
`1052 Madsbad, An Overview of Once-Weekly Glucagon-Like Peptide-1
`Receptor Agonists—Available Efficacy and Safety Data and
`Perspectives for the Future, 13 DIABETES, OBESITY &
`METABOLISM 394 (2011)
`
`1053 Møller, Mechanism-Based Population Modelling for Assessment of
`L-Cell Function Based on Total GLP-1 Response Following an Oral
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`4
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`EXHIBIT
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`DESCRIPTION
`Glucose Tolerance Test, 38 J. PHARMACOKINETICS &
`PHARMACODYNAMICS 713 (2011)
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`1054
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`1055
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`Landersdorfer, Mechanism-Based Population Pharmacokinetic
`Modelling in Diabetes: Vildagliptin as a Tight Binding Inhibitor and
`Substrate of Dipeptidyl Peptidase IV, 73 BRIT. J. CLINICAL
`PHARMACOLOGY 391 (2011) (“Landersdorfer 2011a”)
`
`Landersdorfer, Mechanism-Based Population Modelling of the
`Effects of Vildagliptin on GLP-1, Glucose and Insulin in Patients
`with Type 2 Diabetes, 73 BRIT. J. CLINICAL PHARMACOLOGY
`373 (2011) “(Landersdorfer 2011b”)
`
`1056
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`U.S. Patent No. 5,118,666
`
`1057 WO 2011/073328
`
`1058
`
`Blonde, Comparison of Liraglutide Versus Other Incretin-Related
`Anti-Hyperglycaemic Agents, 14 (suppl. 2) DIABETES, OBESITY
`& METABOLISM 20 (2012)
`
`1059 Murphy, Review of the Safety and Efficacy of Exenatide Once
`Weekly for the Treatment of Type 2 Diabetes Mellitus, 46 ANNALS
`OF PHARMACOTHERAPY 812 (2012)
`
`1060 WO 2011/058193
`
`1061
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`1062
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`1063
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`U.S. Patent App. Pub. No. 2011/0166321
`
`Zarin, The ClinicalTrials.gov Results Database—Update and Key
`Issues, 364 NEW ENGL. J. MED. 852 (2011)
`
`Kirillova, Results and Outcome Reporting in ClinicalTrials.gov,
`What Makes it Happen?, 7(6) PLOS ONE 1 (2012)
`
`1064 Monami, Effects of Glucagon-Like Peptide-1 Receptor Agonists on
`Body Weight: A Meta-Analysis, 2012 EXPERIMENTAL
`DIABETES RSCH. 1 (2012)
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`5
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`EXHIBIT
`1065
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`DESCRIPTION
`Tasneem, The Database for Aggregate Analysis of
`ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical
`Specialty, 7(3) PLOS ONE 1(2012)
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`1067
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`1068
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`1069
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`1070
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`1071
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`1072
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`1073
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`Knudsen, Liraglutide: The Therapeutic Promise from Animal
`Models, 64(suppl 167) INT’L J. CLINICAL PRACTICE 4 (2010)
`(“Knudsen 2010b”)
`
`U.S. Patent No. 8,536,122
`
`U.S. Patent No. 8,129,343
`
`REMINGTON: THE SCIENCE AND PRACTICE OF
`PHARMACY (Alfonso R. Gennaro ed., 20th ed. 2000)
`
`Boylan, Parenteral Products, in MODERN PHARMACEUTICS
`(Gilbert S. Banker et al. eds., 3d ed. 1996)
`
`U.S. Patent No. 6,284,727
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`U.S. Patent No. 5,164,366
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`U.S. Patent No. 6,458,924
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`1074 WO 00/37098
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`1075
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`1076
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`1077
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`1078
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`1079
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`U.S. Patent No. 7,022,674
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`ClinicalTrials.gov Background, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ct2/about-site/background (last visited Mar.
`10, 2023)
`
`Award: ClinicalTrials.gov,
`https://ash.harvard.edu/news/clinicaltrials.gov (last visited Mar. 10,
`2023)
`
`U.S. Patent App. Pub. No. 2004/0102486
`
`NCT00167115, CLINICALTRIALS.GOV,
`https://www.clinicaltrials.gov/ct2/show/NCT00167115 (last visited
`Mar. 10, 2023)
`
`6
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`
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`EXHIBIT
`1080
`
`DESCRIPTION
`NCT01933490, CLINICALTRIALS.GOV,
`https://www.clinicaltrials.gov/ct2/show/NCT01933490 (last visited
`Mar. 10, 2023)
`
`1081
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`1082
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`1083
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`1084
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`1085
`
`1086
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`Ozempic prescribing information (Oct. 2022)
`
`Scheduling Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals
`Inc., No. 22-294 (CFC) (D. Del. June 30, 2022), ECF No. 22
`
`Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation, No.
`3038 (MDL Aug. 5, 2022)
`
`EMA, ICH Topic S 7 A Safety Pharmacology Studies for Human
`Pharmaceuticals (June 2001)
`
`ACS Publications, https://pubs.acs.org/toc/jmcmar/47/17;
`https://pubs.acs.org/doi/10.1021/jm030630m
`
`“Last Update Posted” definition from ClinicalTrials.gov
`https://clinicaltrials.gov/ct2/show/NCT00696657
`
`Prosecution history excerpts for U.S. Patent No. 9,764,003
`1087
`1088 Markman Hearing Transcript, In Re: Ozempic (Semaglutide) Patent
`Litigation, No. 22-MD-3038 (D. Del. July 13, 2023)
`Claim Construction Order, In Re: Ozempic (Semaglutide) Patent
`Litigation, No. 22-MD-3038 (D. Del. July 25, 2023), ECF No. 148
`Joint Claim Construction Brief, In Re: Ozempic (Semaglutide)
`Patent Litigation, No. 22-MD-3038 (D. Del. May 1, 2023), ECF
`No. 119
`Declaration of Dr. Russell M. Zusman
`
`1089
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`1090
`
`1091
`
`1092
`
`1093
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`1094
`
`1095
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`CV of Dr. Russell M. Zusman
`
`Declaration of Dr. John P. Fruehauf
`
`CV of Dr. John P. Fruehauf
`
`Declaration of Dr. Maureen M. Donovan
`
`7
`
`
`
`EXHIBIT
`1096
`
`DESCRIPTION
`CV of Dr. Maureen M. Donovan
`
`1097 Mylan Pharmaceuticals Inc., v. Novo Nordisk A/S, IPR2023-00724,
`Paper 10 (PTAB Oct. 4, 2023)
`
`1098
`
`1099
`
`ORAL ORDER Resetting Scheduling Order Deadlines, Case 1:22-
`md-03038-CFC In Re: Ozempic (Semaglutide) Patent Litigation
`March 25, 2024 4:01:36 PM
`
`Dr. Reddy’s Laboratories, Ltd.’s And Dr. Reddy’s Laboratories,
`Inc.’s Stipulation Concerning Invalidity Grounds, MDL NO. 22-
`MD-3038 (CFC) C.A. No. 22-294 (CFC) Consolidated Anda Case
`(March 2024)
`
`Dated: March 29, 2024
`
`Respectfully Submitted,
`
`/Jovial Wong/
`Jovial Wong (lead counsel)
`Reg. No. 60,115
`Scott M Border (backup counsel)
`Reg. No. 77,744
`Sharon Lin McIntosh (backup counsel)
`(pro hac vice to be submitted)
`Winston & Strawn LLC
`1901 L Street, N.W.
`Washington, D.C. 20036
`T: 202-282-5100
`sborder@winston.com
`jwong@winston.com
`slin@winston.com
`
`
`
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`
`
`8
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on this 29th day of
`
`March, 2024, I caused to be served a true and correct copy of the foregoing by
`
`electronic delivery to Patent Owner’s counsel of record:
`
`
`
`J. Steven Baughman - steve.baughman@groombridgewu.com
`Megan Raymond - megan.raymond@groombridgewu.com
`Novo-Semaglutide-IPR@groombridgewu.com
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`
`
`
`Dated: March 29, 2024
`
`Respectfully Submitted,
`
`/Jovial Wong/
`Jovial Wong (lead counsel)
`Reg. No. 60,115
`Scott M Border (backup counsel)
`Reg. No. 77,744
`Sharon Lin McIntosh (backup counsel)
`(pro hac vice to be submitted)
`Winston & Strawn LLC
`1901 L Street, N.W.
`Washington, D.C. 20036
`T: 202-282-5100
`sborder@winston.com
`jwong@winston.com
`slin@winston.com
`
`
`
`
`
`9
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