Exhibits: Mylan Pharmaceutical Inc.'s Updated Exhibit List Petitioner's Reply (Protective Order Material) Walgreen Co. Recalls LANTUS¿¿ Insulin Glargine (rDNA) Injection, www.SafetyAlerts.com, Nov. 15, 2001, pp. 1-3 EP Pub. 0368187 A2 Amgen, Inc. profile of ¿¿¿NEUPOGEN¿¿¿ (Filgrastim), Apr. 2, 1998, pp. 1-27pp. 1-27 Center for Drug Evaluation and Research, Approval for ¿¿¿NUTROPIN AQ¿¿¿ (App. 20-522/S-10), Apr. 10, 2000 Deposition of Dr. Berhard Trout (June 21, 2018) Deposition of Dr. Laurence Baker, Ph.D. (June 22, 2018) Campbell, Kevin; ¿¿¿Insulin Costs Are Skyrocketing. This is Why.¿¿¿, U.S. News and World Report, June 29, 2018, pp.1-3 MEDWATCH, FDA Medical Products Reporting Program, Report on LANTUS¿¿, Case ID 376724, Apr. 05, 2002 Affidavit of Marlene S. Bobka (July 3, 2018) Aventis Pharmaceuticals, Inc., Individual Safety Report for ¿¿¿LANTUS¿¿¿¿¿, Case 4054424-5-00-01, Feb. 06, 2003 1058A - Affidavit of Marlene S. Bobka (July 3, 2018) Sanofi Press Release, ¿¿¿Prospective Study Published in Diabetes Care Confirms Basal Therapy with LANTUS¿¿ Improves Glycemic Control In Patients with Type 2 Diabetes Poorly Controlled on Prior Insulin Regimens¿¿¿ (June 8, 2005) Sanofi Press Release, ¿¿¿LANTUS¿¿ Add-on to Oral Monotherapy Therapy Showed Improved Glycemic Control in Type 2 Diabetes Patients Compared to oral Actos Add-on to Oral Therapy¿¿¿ (June 13, 2005) Sanofi Press Release, ¿¿¿Data Presented at ADA Showed That Basal Insulin Therapy with LANTUS¿¿ Achieved Target Glycemic Control In Poorly Controlled Type 2 Diabetes¿¿¿ (June 13, 2005) U.S. SEC Form 20-F for Sanofi-Aventis FY 2006 U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 Q4 2005 Sanofi-Aventis Earnings Conference Call Q3 2005 Sanofi-Aventis Earnings Conference Call Q2 2005 Sanofi-Aventis Earnings Conference Call Q1 2005 Sanofi-Aventis Earnings Conference Call LANTUS (NDA 21-081 S-024) ¿¿¿ Labeling-Container Carton Labels, Labeling-Package Insert Rev. Mar. 2007 NDA 21-081 S-005 ¿¿¿ Efficacy-New Dosing Regimen ¿¿¿ Label, Apr. 30, 2003 Mestre-Ferrandiz, et al. The R&D Cost of a New Medicine, Office of Health Economics, pp. 1-100 (Dec. 2012) LANTUS Why Lantus Page "Ask Your Healthcare Provider About Switching to LANTUS" (October 16, 2006) LANTUS Using Lantus "How to Use the Lantus SoloSTAR¿¿ Pen" (Current) LANTUS Savings Card LANTUS Resources (Current) LANTUS New to Lantus Page (October 2006) LANTUS Support "LANTUS Tips and Support" (October 2006) LANTUS Home Page (Current) LANTUS Home Page (October 2006) LANTUS About (Current) LANTUS - Your Diabetes Treatment Routine (Current) LANTUS - How to Inject Lantus With a Vial and Syringe LANTUS - Home Page (Current) LANTUS - Explore Diabetes Treatment Options (Current) PROTECTIVE ORDER MATERIAL- IQVIA ¿¿¿ Diabetes Data FDA Approval Letter ¿¿¿ LANTUS Reformulation March 2005 FDA ¿¿¿ 27th Orange Book (2007) FDA ¿¿¿ 25th Orange Book (2005) DiMasietal, et al. Innovation in the Pharmaceutical Industry New Estimates of R&D Costs J. of Health Eco., 37 (2016) pp. 20-33 David et al. Commercial Success Economic Principles Applied to Patent Litigation, Economics of Pat. Damages, Chap. 9, pp. 159-160 Cowen and Company, Therapeutic Categories Outlook, Comprehensive Study Oct. 2006 CDC Long-Term Trends in Diabetes April 2017 CDC About Diabetes June 1, 2017 U.S. SEC Form 20-F for Sanofi-Aventis FY 2003 U.S. SEC Form 20-F for Sanofi-Aventis FY 2002 ABN AMRO Pharmaceutical Market Share Report Oct. 2001 WebMD Types of Insulin for Diabetes Treatment accessed May 3, 2018 UBS Equities ¿¿¿ Sanofi-Aventis Q405, Jan. 24, 2006 UBS Equities Sanofi-Aventis Q305, Nov. 3, 2005 UBS Equities ¿¿¿ Sanofi-Aventis Q205, Sep. 1, 2005 UBS Equities Sanofi-Aventis Q105 May 13 2005 St. Louis Federal Reserve Economic Data, Consumer Price Index for All Urban Consumers CPI Monthly accessed May 24, 2018 SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2006) SG Cowen Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study Oct. 2005 SG Cowen Pharmaceutical Therapeutic Categories Outlook Comprehensive Study March 2005 SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook, pp. 136-156 (March 2002) SG Cowen Perspectives Pharmaceutical Therapeutic Categories Outlook pp. 134-148 Oct. 2001 Sanofi Press Releases 2006 Sanofi Press Releases 2005 1111A - Curriculum Vitae of Professor Robert Langer PROTECTIVE ORDER MATERIAL - Declaration of Professor Robert Langer Ex. 1111B - References Considered by Professor Robert Langer Baynes et al. Role of Arginine in the Stabilization of Proteins Against Aggregation Biochemistry Baynes et al. Rational Design of Solution Additives for the Prevention of Protein Aggregation Biophysical J. Vol. 87 pp.1631-1639, Sept. 2004 Neuprogen Filgratim Amgen Inc. Product label April 2 1998 Nielsen et al. Effect of Environmental Factors On the Kinetics of Insulin Fibril Formation: Elucidation of the Molecular Mechanism Biochemistry 2001 40 pp. 6036-6046 2001 Shao et al Differential Effects of Anionic, Cationic, Nonionic, and Physiologic Surfactants on Manning et al. Stability of Protein Pharmaceuticals WO8300288 CA1258427 Hawley's Condensed Chemical Dictionary, 12th Ed. Wan et al. CMC of Polysorbates, J. of Pharma. Sciences WO0023098 Farhadieh, Determination of CMC and Partial Specific Volume of Polysorbates K.L. Mittal Determination of CMC of Polysorbate 20 in Aqueous Solution by Surface Tension Method AU200072263 A1 EP 1019022 B1 U.S. Patent No. 6211144 U.S. Patent No. 6335316 Safety Alerts Internet Archive Walgreen Co. Recalls Lantus Insulin Glargine (rDNA origin) Injection Nov. 15 2001 Conway-Jacobs et al. Isoelectric Focusing in Acrylamide Gels¿¿¿ Use of Amphoteric Dyes As Internal markers For Determination of Isoelectric Points U.S. Patent No. 6737401 A. Martin et al. Physical Principles In the Pharmaceutical Sciences Affidavit of M.T. Lanterman - IPR2017-01526 and IPR2017-01528 PDR 1997 Pgs. 1488-1490 Humalog insulin Physicians' Desk Reference 1997 Pgs. 1497-1498 LANGER, R. et al. US 2015/0320837 LANGER, Robert, et al. U.S. Publication No. 20150320837 Nov. 12 2015 LANGER, Robert S. et al. U.S. Patent No. 9994615 B2 2001 PDR Entry for Etoposide p. 825 2001 PDR Entry for Limbitrol p1538 2001 PDR Entry for Norditropin p. 2236 LANGER, Robert S. et al. WO2013123492 A1, Aug. 22, 2013 2001 PDR Entry for Novoline, pp. 2238-2242 PROTECTIVE ORDER MATERIAL- Aventis, NDA 21-081 Formulation Optimization PROTECTIVE ORDER MATERIAL - Aventis LANTUS PROTECTIVE ORDER MATERIAL - Aventis Formulation Development Report Insulin Glargine PROTECTIVE ORDER MATERIAL - Aventis Lantus Multi Dose Vial (10 ml) Complaint Situation PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml Vials PROTECTIVE ORDER MATERIAL- SANOFI Insulin Glargine ¿¿¿ Solution for Injection Container Closure System Injection Vial 5 and 10 mL May 2013 SANOFI_00430764 PROTECTIVE ORDER MATERIAL - Aventis Response to Agency Request Insulin Glargine Solution for Injection, 100 IU/ml, Jan. 13, 2005, SANOFI_01593692 PROTECTIVE ORDER MATERIAL - Aventis Development Status Report, HOE 901 In-use Stability of HOE 901 Solution for Injection May 2001 SANOFI_01594032 PROTECTIVE ORDER MATERIAL - Aventis Summary Report Lantus mL Vials ¿¿¿ Complaints Turbidity Description and Measurements, Aug. 19, 2002, SANOFI_01594042 PROTECTIVE ORDER MATERIAL-- Aventis LANTUS HOE 901D - Formulation Improvement Strategy GPT/MAX Team Meeting, June 14, 2003, SANOFI_01628810 PROTECTIVE ORDER MATERIAL- Aventis Formulation Optimization Decision to Submit PROC June 2, 2004, SANOFI_01664827 PROTECTIVE ORDER MATERIAL- Aventis Formulation Optimization Decision to Submit for 10-ml Vials, PPRC, June 17, 2004, SANOFI_01665660 PROTECTIVE ORDER MATERIAL- Aventis Comparative in Use of Stability of Lantus and Other Insulins, SANOFI_01666332 PROTECTIVE ORDER MATERIAL- Aventis Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml. Vials, Complaints Concerning Turbidity, July 24, 2001, SANOFI_01667979 PROTECTIVE ORDER MATERIAL- Aventis Reformulation LANTUS IO QO View, Nov. 7, 2014, SANOFI_01747290 PROTECTIVE ORDER MATERIAL- E-mail Contact Report from FDA to M. Lutz, Regulatory Affairs, for proposed FDA Revision, April 28, 2003 SANOFI_01815531 PROTECTIVE ORDER MATERIAL- Aventis Pharma Lantus Injectable 10 ml. Vial Insulin Glargine NDA 21-081 Field Alert July 12, 2001 SANOFI_70006138 PROTECTIVE ORDER MATERIAL- Aventis Pharma, Formulation Development Report Insulin Glargine, Lantus Formulation HOE 901 (30) R, SANOFI3_90297269 Gerhard Wenske, Dictionary of Chemistry German-English 1st ed. 1994 U.S. Patent No. 4,783,441 Thurow 1998 U.S. Patent No. 4,849,227 Cho U.S. Patent No. 5,518,998 Backstrom U.S, Patent No. 6,306,440 Backstrom 2001 U.S. Patent No. 6,656,499 Foldvari Z. Strickley, Stability of Human Insulin Effect of Water Content and Added Excipients on the Degradation of Lyophilized Insulin at Acidic pH, Thesis Dept. of Pharm. and Pharmaceutical Chem. U. of Utah, Dec. 1995 Declaration of DeForest McDuff Ex. 1169E- Lantus Prescriptions Ex. 1169F - Lantus Market Shares Ex. 1169A - Curriculum Vitae of DeForest McDuff Ex. 1169B - Revenues by Product Ex. 1169C - Diabetes Patient Population Ex. 1169D - Insulin Product Sales Pak, et al. A Simple Apparatus For Measurement of Protein Monofilm Expansion At Air-Water Interface in Response to Soluble Reactants in the Subsolution, J. of Colloid Sci., 16, pp. 513-530 1961 U.S. Patent No. 6,100,376 U.S. Patent No. 5,656,722 Susan Budavari et al., The Merck Index An Encyclopedia of Chemicals Drugs and Biologicals 12th ed. 1996 Declaration of William Curtis Biggs Ex. 1174A - Curriculum Vitae of William Curtis Biggs Diabetes Complications and Control Trial (DCCT) (1993) March 2, 2003 Usenet forum post by William Biggs, Preloading Lantus in syringes, misc.health.diabetes, Phys. Desk Ref., Iletin, 1997, pp. 1503-1504 Phys. Desk Ref. Iletin II 1997, pp. 1507-1509 Velosulin BR Buffered Regular Human Insulin Injection (rDNA origin), Physicians' Desk Reference 56 ed. 2002, pg. 2435 Novolin R Regular, Human Insulin Injection, (recombinant DNA origin), Physicians' Desk Reference 56 ed. 2002, pg. 2423 Declaration of Professor Samuel H. Yalkowsky Physicians' Desk Reference - Venofer
IPR2017-01528, No. 1118 Exhibit - WO8300288 (P.T.A.B. Jul. 13, 2018)
Exhibits: Mylan Pharmaceutical Inc.'s Updated Exhibit List Petitioner's Reply (Protective Order Material) Walgreen Co. Recalls LANTUS¿¿ Insulin Glargine (rDNA) Injection, www.SafetyAlerts.com, Nov. 15, 2001, pp. 1-3 EP Pub. 0368187 A2 Amgen, Inc. profile of ¿¿¿NEUPOGEN¿¿¿ (Filgrastim), Apr. 2, 1998, pp. 1-27pp. 1-27 Center for Drug Evaluation and Research, Approval for ¿¿¿NUTROPIN AQ¿¿¿ (App. 20-522/S-10), Apr. 10, 2000 Deposition of Dr. Berhard Trout (June 21, 2018) Deposition of Dr. Laurence Baker, Ph.D. (June 22, 2018) Campbell, Kevin; ¿¿¿Insulin Costs Are Skyrocketing. This is Why.¿¿¿, U.S. News and World Report, June 29, 2018, pp.1-3 MEDWATCH, FDA Medical Products Reporting Program, Report on LANTUS¿¿, Case ID 376724, Apr. 05, 2002 Affidavit of Marlene S. Bobka (July 3, 2018) Aventis Pharmaceuticals, Inc., Individual Safety Report for ¿¿¿LANTUS¿¿¿¿¿, Case 4054424-5-00-01, Feb. 06, 2003 1058A - Affidavit of Marlene S. Bobka (July 3, 2018) Sanofi Press Release, ¿¿¿Prospective Study Published in Diabetes Care Confirms Basal Therapy with LANTUS¿¿ Improves Glycemic Control In Patients with Type 2 Diabetes Poorly Controlled on Prior Insulin Regimens¿¿¿ (June 8, 2005) Sanofi Press Release, ¿¿¿LANTUS¿¿ Add-on to Oral Monotherapy Therapy Showed Improved Glycemic Control in Type 2 Diabetes Patients Compared to oral Actos Add-on to Oral Therapy¿¿¿ (June 13, 2005) Sanofi Press Release, ¿¿¿Data Presented at ADA Showed That Basal Insulin Therapy with LANTUS¿¿ Achieved Target Glycemic Control In Poorly Controlled Type 2 Diabetes¿¿¿ (June 13, 2005) U.S. SEC Form 20-F for Sanofi-Aventis FY 2006 U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 Q4 2005 Sanofi-Aventis Earnings Conference Call Q3 2005 Sanofi-Aventis Earnings Conference Call Q2 2005 Sanofi-Aventis Earnings Conference Call Q1 2005 Sanofi-Aventis Earnings Conference Call LANTUS (NDA 21-081 S-024) ¿¿¿ Labeling-Container Carton Labels, Labeling-Package Insert Rev. Mar. 2007 NDA 21-081 S-005 ¿¿¿ Efficacy-New Dosing Regimen ¿¿¿ Label, Apr. 30, 2003 Mestre-Ferrandiz, et al. The R&D Cost of a New Medicine, Office of Health Economics, pp. 1-100 (Dec. 2012) LANTUS Why Lantus Page "Ask Your Healthcare Provider About Switching to LANTUS" (October 16, 2006) LANTUS Using Lantus "How to Use the Lantus SoloSTAR¿¿ Pen" (Current) LANTUS Savings Card LANTUS Resources (Current) LANTUS New to Lantus Page (October 2006) LANTUS Support "LANTUS Tips and Support" (October 2006) LANTUS Home Page (Current) LANTUS Home Page (October 2006) LANTUS About (Current) LANTUS - Your Diabetes Treatment Routine (Current) LANTUS - How to Inject Lantus With a Vial and Syringe LANTUS - Home Page (Current) LANTUS - Explore Diabetes Treatment Options (Current) PROTECTIVE ORDER MATERIAL- IQVIA ¿¿¿ Diabetes Data FDA Approval Letter ¿¿¿ LANTUS Reformulation March 2005 FDA ¿¿¿ 27th Orange Book (2007) FDA ¿¿¿ 25th Orange Book (2005) DiMasietal, et al. Innovation in the Pharmaceutical Industry New Estimates of R&D Costs J. of Health Eco., 37 (2016) pp. 20-33 David et al. Commercial Success Economic Principles Applied to Patent Litigation, Economics of Pat. Damages, Chap. 9, pp. 159-160 Cowen and Company, Therapeutic Categories Outlook, Comprehensive Study Oct. 2006 CDC Long-Term Trends in Diabetes April 2017 CDC About Diabetes June 1, 2017 U.S. SEC Form 20-F for Sanofi-Aventis FY 2003 U.S. SEC Form 20-F for Sanofi-Aventis FY 2002 ABN AMRO Pharmaceutical Market Share Report Oct. 2001 WebMD Types of Insulin for Diabetes Treatment accessed May 3, 2018 UBS Equities ¿¿¿ Sanofi-Aventis Q405, Jan. 24, 2006 UBS Equities Sanofi-Aventis Q305, Nov. 3, 2005 UBS Equities ¿¿¿ Sanofi-Aventis Q205, Sep. 1, 2005 UBS Equities Sanofi-Aventis Q105 May 13 2005 St. Louis Federal Reserve Economic Data, Consumer Price Index for All Urban Consumers CPI Monthly accessed May 24, 2018 SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2006) SG Cowen Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study Oct. 2005 SG Cowen Pharmaceutical Therapeutic Categories Outlook Comprehensive Study March 2005 SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook, pp. 136-156 (March 2002) SG Cowen Perspectives Pharmaceutical Therapeutic Categories Outlook pp. 134-148 Oct. 2001 Sanofi Press Releases 2006 Sanofi Press Releases 2005 1111A - Curriculum Vitae of Professor Robert Langer PROTECTIVE ORDER MATERIAL - Declaration of Professor Robert Langer Ex. 1111B - References Considered by Professor Robert Langer Baynes et al. Role of Arginine in the Stabilization of Proteins Against Aggregation Biochemistry Baynes et al. Rational Design of Solution Additives for the Prevention of Protein Aggregation Biophysical J. Vol. 87 pp.1631-1639, Sept. 2004 Neuprogen Filgratim Amgen Inc. Product label April 2 1998 Nielsen et al. Effect of Environmental Factors On the Kinetics of Insulin Fibril Formation: Elucidation of the Molecular Mechanism Biochemistry 2001 40 pp. 6036-6046 2001 Shao et al Differential Effects of Anionic, Cationic, Nonionic, and Physiologic Surfactants on Manning et al. Stability of Protein Pharmaceuticals WO8300288 CA1258427 Hawley's Condensed Chemical Dictionary, 12th Ed. Wan et al. CMC of Polysorbates, J. of Pharma. Sciences WO0023098 Farhadieh, Determination of CMC and Partial Specific Volume of Polysorbates K.L. Mittal Determination of CMC of Polysorbate 20 in Aqueous Solution by Surface Tension Method AU200072263 A1 EP 1019022 B1 U.S. Patent No. 6211144 U.S. Patent No. 6335316 Safety Alerts Internet Archive Walgreen Co. Recalls Lantus Insulin Glargine (rDNA origin) Injection Nov. 15 2001 Conway-Jacobs et al. Isoelectric Focusing in Acrylamide Gels¿¿¿ Use of Amphoteric Dyes As Internal markers For Determination of Isoelectric Points U.S. Patent No. 6737401 A. Martin et al. Physical Principles In the Pharmaceutical Sciences Affidavit of M.T. Lanterman - IPR2017-01526 and IPR2017-01528 PDR 1997 Pgs. 1488-1490 Humalog insulin Physicians' Desk Reference 1997 Pgs. 1497-1498 LANGER, R. et al. US 2015/0320837 LANGER, Robert, et al. U.S. Publication No. 20150320837 Nov. 12 2015 LANGER, Robert S. et al. U.S. Patent No. 9994615 B2 2001 PDR Entry for Etoposide p. 825 2001 PDR Entry for Limbitrol p1538 2001 PDR Entry for Norditropin p. 2236 LANGER, Robert S. et al. WO2013123492 A1, Aug. 22, 2013 2001 PDR Entry for Novoline, pp. 2238-2242 PROTECTIVE ORDER MATERIAL- Aventis, NDA 21-081 Formulation Optimization PROTECTIVE ORDER MATERIAL - Aventis LANTUS PROTECTIVE ORDER MATERIAL - Aventis Formulation Development Report Insulin Glargine PROTECTIVE ORDER MATERIAL - Aventis Lantus Multi Dose Vial (10 ml) Complaint Situation PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml Vials PROTECTIVE ORDER MATERIAL- SANOFI Insulin Glargine ¿¿¿ Solution for Injection Container Closure System Injection Vial 5 and 10 mL May 2013 SANOFI_00430764 PROTECTIVE ORDER MATERIAL - Aventis Response to Agency Request Insulin Glargine Solution for Injection, 100 IU/ml, Jan. 13, 2005, SANOFI_01593692 PROTECTIVE ORDER MATERIAL - Aventis Development Status Report, HOE 901 In-use Stability of HOE 901 Solution for Injection May 2001 SANOFI_01594032 PROTECTIVE ORDER MATERIAL - Aventis Summary Report Lantus mL Vials ¿¿¿ Complaints Turbidity Description and Measurements, Aug. 19, 2002, SANOFI_01594042 PROTECTIVE ORDER MATERIAL-- Aventis LANTUS HOE 901D - Formulation Improvement Strategy GPT/MAX Team Meeting, June 14, 2003, SANOFI_01628810 PROTECTIVE ORDER MATERIAL- Aventis Formulation Optimization Decision to Submit PROC June 2, 2004, SANOFI_01664827 PROTECTIVE ORDER MATERIAL- Aventis Formulation Optimization Decision to Submit for 10-ml Vials, PPRC, June 17, 2004, SANOFI_01665660 PROTECTIVE ORDER MATERIAL- Aventis Comparative in Use of Stability of Lantus and Other Insulins, SANOFI_01666332 PROTECTIVE ORDER MATERIAL- Aventis Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml. Vials, Complaints Concerning Turbidity, July 24, 2001, SANOFI_01667979 PROTECTIVE ORDER MATERIAL- Aventis Reformulation LANTUS IO QO View, Nov. 7, 2014, SANOFI_01747290 PROTECTIVE ORDER MATERIAL- E-mail Contact Report from FDA to M. Lutz, Regulatory Affairs, for proposed FDA Revision, April 28, 2003 SANOFI_01815531 PROTECTIVE ORDER MATERIAL- Aventis Pharma Lantus Injectable 10 ml. Vial Insulin Glargine NDA 21-081 Field Alert July 12, 2001 SANOFI_70006138 PROTECTIVE ORDER MATERIAL- Aventis Pharma, Formulation Development Report Insulin Glargine, Lantus Formulation HOE 901 (30) R, SANOFI3_90297269 Gerhard Wenske, Dictionary of Chemistry German-English 1st ed. 1994 U.S. Patent No. 4,783,441 Thurow 1998 U.S. Patent No. 4,849,227 Cho U.S. Patent No. 5,518,998 Backstrom U.S, Patent No. 6,306,440 Backstrom 2001 U.S. Patent No. 6,656,499 Foldvari Z. Strickley, Stability of Human Insulin Effect of Water Content and Added Excipients on the Degradation of Lyophilized Insulin at Acidic pH, Thesis Dept. of Pharm. and Pharmaceutical Chem. U. of Utah, Dec. 1995 Declaration of DeForest McDuff Ex. 1169E- Lantus Prescriptions Ex. 1169F - Lantus Market Shares Ex. 1169A - Curriculum Vitae of DeForest McDuff Ex. 1169B - Revenues by Product Ex. 1169C - Diabetes Patient Population Ex. 1169D - Insulin Product Sales Pak, et al. A Simple Apparatus For Measurement of Protein Monofilm Expansion At Air-Water Interface in Response to Soluble Reactants in the Subsolution, J. of Colloid Sci., 16, pp. 513-530 1961 U.S. Patent No. 6,100,376 U.S. Patent No. 5,656,722 Susan Budavari et al., The Merck Index An Encyclopedia of Chemicals Drugs and Biologicals 12th ed. 1996 Declaration of William Curtis Biggs Ex. 1174A - Curriculum Vitae of William Curtis Biggs Diabetes Complications and Control Trial (DCCT) (1993) March 2, 2003 Usenet forum post by William Biggs, Preloading Lantus in syringes, misc.health.diabetes, Phys. Desk Ref., Iletin, 1997, pp. 1503-1504 Phys. Desk Ref. Iletin II 1997, pp. 1507-1509 Velosulin BR Buffered Regular Human Insulin Injection (rDNA origin), Physicians' Desk Reference 56 ed. 2002, pg. 2435 Novolin R Regular, Human Insulin Injection, (recombinant DNA origin), Physicians' Desk Reference 56 ed. 2002, pg. 2423 Declaration of Professor Samuel H. Yalkowsky Physicians' Desk Reference - Venofer
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