Before the Patent Trial and Appeal Board ______

UNITED STATES PATENT AND TRADEMARK OFFICE ______

BEFORE THE PATENT TRIAL AND APPEAL BOARD ______

MERCK SHARP & DOHME CORP.,

Petitioner,

MAYNE PHARMA INTERNATIONAL PTY LTD.,

Patent Owner. ______

Case IPR2016-01186

U.S. Patent No. 6,881,745 ______

PATENT OWNER’S UPDATED EXHIBIT LIST

Mail Stop Patent Board Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450 Pursuant to 37 C.F.R. § 42.63(e), the Patent Owner hereby provides its updated exhibit list:

Exhibit Description No.

2001 Declaration of Robert A. Bellantone, Ph.D. 2002 Curriculum Vitae of Robert A. Bellantone, Ph.D. 2003 Certified File History, U.S. Patent No. 6,881,745 2004 Plaintiff’s Opening Claim Construction Brief, Sept. 7, 2016 2005 Webster's Third New International Dictionary 1694 (3d ed.1993) 2006 Merriam-Webster’s Collegiate Dictionary 870-71 (10th ed. 1998) 2007 Dictionary of Biochemistry and Molecular Biology 355 (2d ed. 1989) 2008 Lin, J., Species Similarities and Differences in Pharmacokinetics, 23 Drug Metabolism & Disposition 1008-1021 (1995) 2009 Miyoshi, T., et al., Effect of Maltosyl-β-Cyclodextrin on Drug Binding to Serum Albumin, 5 J. Pharm. Sci. & Tech., Japan 174-180 (1997) 2010 Defendants Merck & Co., Inc. and Merck Sharp & Dohme Corp.’s Opening Claim Construction Brief, Sept. 7, 2016 2011 Dorland’s Illustrated Medical Dictionary 91, 198, 484, 524, 740 (28th ed. 1994).) 2012 Highlights of Prescribing Information, Albenza 2013 Excerpt of Merck's Claim Construction Technology Tutorial 2014 Press Release, SEC, Merck and Schering-Plough to Complete Merger Today, https://www.sec.gov/Archives/edgar/data/310158/00011931250922391 7/dex991.htm, accessed Sept. 19, 2016 2015 U.S. Patent Application Publication 2011/0034478 2016 Excerpt from Prosecution History for Application No. 12/937,881, December 4, 2012 Office Action 2017 Excerpt from Prosecution History for Application No. 12/937,881, March 4, 2013 Response to Office Action 2018 Excerpt from Prosecution History for Application No. 12/937,881, Notice of Abandonment 2019 Graybill, J., The Future of Antifungal Therapy, 22 Clinical Infectious Diseases S166-S178 (1996)

Exhibit Description No.

2020 Loebenberg, D., et al., In Vitro and In Vivo Activities of SCH 42427, the Active Enantiomer of the Antifungal Agent SCH 39304, 36(2) Antimicrobial Agents & Chemotherapy 498-501 (1992). 2021 Merck & Co., Inc., Merck Sharp & Dohme Corp. and N.V. Organon Corporate Disclosure Statement, dated Sept. 16, 2015 (15-cv-00438- LPS-CJB) 2022 Merck General Corporate Resolution No. 5 2023 Richard Gronchala Patent Registration Information 2024 Richard Gronchala NY Bar Registration Information 2025 Richard Gronchala LinkedIn Profile 2026 Second Amended Complaint, dated Feb. 22, 2016 (15-cv-00438-LPS- CJB) 2027 Plaintiff Mayne Pharma International Pty Ltd.’s Preliminary Infringement Chart Regarding U.S. Patent No. 6,881,745, dated Mar. 25, 2016 (15-cv-00438-LPS-CJB) 2028 Merck & Co., Inc. and Merck Sharp & Dohme Corp.’s Answer to Second Amended Complaint, dated Mar. 10, 2016 (15-cv-00438-LPS- CJB) 2029 Excerpt of Merck & Co., Inc. and Merck Sharp & Dohme Corp.’s Preliminary Invalidity Contentions, dated June 13, 2016 (15-cv-00438- LPS-CJB) 2030 Protective Order, dated Mar. 10, 2016 (15-cv-00438-LPS-CJB) 2031 Karen Stoffan Patent Bar Registration Information 2032 Karen Stoffan NY Bar Registration Information 2033 Yong Zhao Patent Bar Registration Information 2034 Yong Zhao LinkedIn Profile 2035 Brief of Amicus Curiae Merck & Co., Inc. in Support of Petitioner, Biogen MA, Inc., v. Japanese Foundation for Cancer Research and Bayer Pharma AG (No. 15-607) 2036 Gerard Devlin Patent Bar Registration Information 2037 Gerard Devlin LinkedIn Profile 2038 William Krovatin Patent Bar Registration Information 2039 William Krovatin NY Bar Registration Information 2040 Excerpt from Merck Sharp & Dohme Corp. v. Ono Pharmaceutical Co., No. IPR2016-01219, Paper No. 1 (P.T.A.B. Jun. 29, 2016).

Exhibit Description No.

2041 Merck Sharp & Dohme Corp. v. Ono Pharmaceutical Co., No. IPR2016-01219, Paper No. 2 (P.T.A.B. Jun. 29, 2016) 2042 Apotex, Inc. v. Merck Sharp & Dohme Corp., No. IPR2015-00419, Paper No. 11 (P.T.A.B. Mar. 18, 2015) 2043 Merck Website Excerpt re: About Us 2044 Email from W. Krovatin to K. Rintoul re Final IPR – Merck v. Mayne, dated June 13, 2016 2045 Merck Website Excerpt re: Contact Information Email from W. Krovatin to K. Rintoul re: Noxafil tabs, dated Aug. 17, 2046 2015 (Redacted) Email from I. Dukes to S. Richards re: Posaconazole Opportunity, 2047 dated Aug. 26, 2014 (Redacted) Press Release, Merck & Co., Inc., Sun Pharma and Merck & Co. Inc., Enter into Licensing Agreement for Tildrakizumab, Published on Merck Newsroom Home (http://www.mercknewsroom.com) on 9/17/14 2048 8:30 am EDT 2049 Iain Dukes LinkedIn Fresenius Kabi USA LLC v. Cubist Pharms., Inc., Power of Attorney, 2050 No IPR2015-01566 (P.T.A.B. Jul. 27, 2015) Merck & Co., Inc. Form 10Q for the Quarterly Period Ended June 30, 2051 2016 Merck & Co., Inc. Presentation, Cowen 2015 Healthcare Conference, 2052 dated Mar. 3, 2015 2053 Highlights of Prescribing Information, Noxafil Kuczmarski, R., et al., Varying Body Mass Index Cutoff to Describe Overweight Prevalence Among US Adults, 5(6) Obesity Res. 542-548 2054 (1997) Dismukes, W., Introduction to Antifungal Drugs, 30 Clin. Infectious 2055 Diseases 653-657 (2000) Proof of Service for Merck and Co., Inc. and Merck Sharp and Dohme 2056 Corp., dated June 12, 2015 (15-cv-00438-LPS-CJB) FDA Guidance for Industry, M3 Nonclinical Safety Studies for the 2057 Conduct of Human Clinical Trials for Pharmaceuticals FDA Guidance for Industry, E6 Good Clinical Practice: Consolidated 2058 Guidance

Exhibit Description No.

Sabatelli, F., et al., In Vitro Activities of Posaconazole, Fluconazole, Itraconazole, Voriconazole, and Amphotericin B against a Large Collection of Clinically Important Molds and Yeasts, 50(6) 2059 Antimicrobrial Agents and Chemotherapy 2009-2015 (2006) Stroyer, A., et al., Solid State Interactions Between the Proton Pump Inhibitor Omeprazole and Various Enteric Coating Polymers, 95(6) J. 2060 Pharm. Sci. 1342-1353 (2005) Biology (Neil A. Campbell & Jane B. Reece eds., (2005) 530-531, 646- 2061 648 Transcript of Initial Conference Call before the Patent Trial and Appeal 2062 Board, January 23, 2017 Transcript of Conference Call before the Patent Trial and Appeal 2063 Board, February 24, 2017 2064 Mayne Pharma International v. Merck & co., Inc., et al, C.A. No. 15- cv-00438, Claim Construction Order 2065 Mayne Pharma International v. Merck & co., Inc., et al, C.A. No. 15- cv-00438, Claim Construction Opinion 2066 Supplemental Declaration of Robert A. Bellantone, Ph.D. 2067 Certified Translation of Miyoshi, T., et al., Effect of Maltosyl-β- Cyclodextrin on Drug Binding to Serum Albumin, 5 J. Pharm. Sci. & Tech., Japan 174-180 (1997) 2068 D. Crowther , Infection Associated with Immunosuppressive Therapy, Postgraduate Med. J., 48, 325-329 (1972) 2069 Sporanox Label 2070 MERCK438_0094066 2071 MERCK438_0110741-0746 2072 Deposition Transcript of David Grainger, Feb. 24, 2017 2073 Response Letter re European Patent Application No. 09732492.5 2074 Fang, U.S. Application No. 12/999,547 2075 Docket Navigator Statistics 2076 Deposition Transcript of Gopal Krishna, Dec. 14, 2016 2077 Declaration of DeForest McDuff, 2078 C.V. of DeForest McDuff 2079 FDA Orange Book, 2016 2080 Mayne Pharma International v. Merck & co., Inc., et al, C.A. No. 15- cv-00438, Claim Construction Hearing Transcript

Exhibit Description No.

2081 Deposition Transcript of Terrence Blaschke, March 10, 2017 2082 MERCK438_0042434-3398 (Excerpt) 2083 MERCK438_0111682 2084 MERCK438_0097229-97333 2085 Rachel Courtney, et al., Effect of Food on the Relative Bioavailability of Two Oral Formulations of Posaconazole in Healthy Adults, J. Clin. Pharmacol., (2003) 2086 Rachel Courtney, et al., Pharmacokinetics of Posaconazole Coadministered with Antacid in Fasting or Nonfasting Healthy Men, Antimicrobial Agents and Chemotherapy, 48(3) 804-808 (2004) 2087 MERCK438_0000685-0723 2088 Gopal Krishna , et al., Single-Dose Phase I Study to Evaluate the Pharmacokietics of Posaconazole in New Tablet and Capsule Formulations Relative to Oral Suspension, 56(8), 4196-4201 (2012) 2089 MERCK438_0112185-2266 2090 U.S Patent Publication 2003/0055067 (Sharpe, et al.) 2091 U.S. Pat. No. 5,834,472 (Sangekar, et al.) 2092 Joseph Barone, et al., Enhanced Bioavailability of Itraconazole in Hydroxypropyl-β-Cyclodextrin Solution versus Capsules in Healthy Volunteers, Antimicrobial Agents and Chemotherapy, 42(7) 1862- 1865 (1998) 2093 U.S. Patent No. 5,633,015 (Gillis) 2094 U.S. Pat. No. 5,846,971 (Sangekar) 2095 Deposition Transcript of William Krovatin, March 22, 2017 2096 Deposition Transcript of Karen Stoffan, March 28, 2017 2097 2016 Merck & Co., Inc. 10-k 2098 Patent Owner’s Mandatory Notice, Torrent Pharmaceuticals Limited, v. Merck Frosst Canada & Co., No. IPR2014-00559, (P.T.A.B. May 2, 2014) 2099 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00131, (P.T.A.B. Feb. 3, 2015) 2100 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00132, (P.T.A.B. Feb. 3, 2015) 2101 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan

Exhibit Description No.

Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00140, (P.T.A.B. Feb. 3, 2015) 2102 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00141, (P.T.A.B. Feb. 3, 2015) 2103 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00142, (P.T.A.B. Feb. 3, 2015) 2104 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00143, (P.T.A.B. Feb. 3, 2015) 2105 Patent Owner’s Mandatory Notice, Agila Specialties Inc. and Mylan Pharmaceuticals Inc., v. Cubist Pharmaceuticals Inc., No. IPR2015- 00144, (P.T.A.B. Feb. 3, 2015) 2106 Patent Owner’s Mandatory Notice, Fresenius-Kabi USA LLC, v. Cubist Pharmaceuticals Inc., No. IPR2015-00223, (P.T.A.B. Feb. 3, 2015) 2107 Patent Owner’s Mandatory Notice, Fresenius-Kabi USA LLC, v. Cubist Pharmaceuticals Inc., No. IPR2015-00227, (P.T.A.B. Feb. 3, 2015) 2108 Patent Owner’s Mandatory Notice, Fresenius-Kabi USA LLC, v. Cubist Pharmaceuticals Inc., No. IPR2015-01566, (P.T.A.B. July 30, 2015) 2109 Patent Owner’s Mandatory Notice, Fresenius-Kabi USA LLC, v. Cubist Pharmaceuticals Inc., No. IPR2015-01570, (P.T.A.B. Aug. 13, 2015) 2110 Patent Owner’s Mandatory Notice, Fresenius-Kabi USA LLC, v. Cubist Pharmaceuticals Inc., No. IPR2015-01571, (P.T.A.B. July 30, 2015) 2111 Patent Owner’s Mandatory Notice, Fresenius-Kabi USA LLC, v. Cubist Pharmaceuticals Inc., No. IPR2015-01572, (P.T.A.B. July 30, 2015) 2112 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Ono Pharmaceutical Co., LTD. and Tasuku Honjo, No. IPR2016-01218, June 29, 2016 (Excerpt) 2113 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Ono Pharmaceutical Co., LTD. and Tasuku Honjo, No. IPR2016-01219, June 29, 2016 (Excerpt) 2114 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Ono Pharmaceutical Co., LTD. and Tasuku Honjo, No. IPR2016-01221, June 29, 2016 (Excerpt) 2115 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v.

Exhibit Description No.

Wyeth LLC, No. IPR2017-00378, Dec. 1, 2016 (Excerpt) 2116 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. IPR2017-00380, Dec. 1, 2016 (Excerpt) 2117 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. IPR2017-00390, Dec. 2, 2016 (Excerpt) 2118 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. IPR2017-01194, March 29, 2017 (Excerpt) 2119 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. IPR2017-01211, March 30, 2017 (Excerpt) 2120 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. IPR2017-01215, March 30, 2017 (Excerpt) 2121 Petition for Inter Partes Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. IPR2017-01223, March 31, 2017 (Excerpt) 2122 Petition for Post Grant Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. PGR2017-00016, March 22, 2017 (Excerpt) 2123 Petition for Post Grant Review, Merck Sharp & Dohme Corp. v. Wyeth LLC, No. PGR2017-00017, March 24, 2017 (Excerpt) 2124 Mayne Pharma International v. Merck & co., Inc., et al, C.A. No. 15- cv-00438, Merck Privilege Log Mayne Pharma International v. Merck & co., Inc., et al, C.A. No. 15- 2125 cv-00438, Merck’s Supplemental Privilege Log 2126 MERCK438_0010352-353 2127 MERCK438_0010473 2128 MERCK438_0010401 2129 MERCK438_0020457 2130 MERCK438_0019886 - 888 2131 Merck Investor Page 2132 Complaint, Merck & Co., et al., v. Merck KGAA, C.A. No. 16-cv-0266 Complaint, Merck & Co., et al., v. United Steelworkers America, C.A. 2133 No. 16-cv-05459 Exhibit A to Complaint, Merck & Co., et al., v. United Steelworkers 2134 America, C.A. No. 16-cv-05459 Notice of Withdrawal of Pro Hac Vice Counsel, Idenix Pharmaceuticals 2135 v. Gilead, C.A. No. 14-cv-00109 October 24, 2016 Merck & co. Request for Extension of Deadline to 2136 File Comments in FDA-2010-N-0548

Exhibit Description No.

2137 2015 Drug and Medical Device Litigation 2138 Alan Modlinger LinkedIn Profile 2139 2017 15th Advanced Summit on Life Sciences Patents 2140 Intellectual Property Owners Association Board of Directors Brief of Intellectual Property Owners Association as Amicus Curiae in 2141 Support of Neither Party, No. 2015-1944, 1945, 1946. (Excerpt) 2142 2016 Patent Litigation Study: Insights on the Annual Review Response to Notice of Non-Compliant Amendment, Case No. 2143 PD2009.6813US PCT, May 6, 2014 2144 Offer to Purchase for Cash re Indenix Pharmaceuticals (Excerpt) Cowen and Company, “Therapeutic Categories Outlook: 2145 Comprehensive Study,” 9/2016 Cowen and Company, “Therapeutic Categories Outlook: 2146 Comprehensive Study,” 10/2013. Cowen and Company, “Therapeutic Categories Outlook: 2147 Comprehensive Study,” 10/2014. 2148 Bear Stearns, Schering Plough Corporation, 11/2/2005 David, Jesse and Marion Steward (2006), “Commercial Success: Economic Principles Applied to Patent Litigation,” Chapter in Economic Damages in Intellectual Property, edited by Daniel Slottje, 2149 John Wiley & Sons, Inc.: Hoboken, NJ, 159–170. 2150 Thomson One, Merck 2151 Cowen and Company, Merck, 02/15/17 2152 Top-selling antifungal sales from JMP Securities, Scynexis 6/2/2014 2153 Cyclosporine Capsules Eon Labs Printed Labeling 2000 2154 Sandimmune Label 2155 U.S. Patent Application 2003/0055067 (Sharpe, et al.) Mestre-Ferrandiz, Jorge, Jon Sussex, and Adrian Towse (2012), “The R&D Cost of a New Medicine,” Office of Health Economics, London 2156 UK 2157 IMS Data DiMasi, Joseph, et al. (2004), “R&D Costs and Returns by Therapeutic 2158 Category,” Drug Information Journal: 38, 211-223 DiMasi, Joseph, Henry Grabowski, and Ronald Hansen (2016), “Innovation in the pharmaceutical industry: New estimates of R&D 2159 costs,” Journal of Health Economics 47: 20–33.

Exhibit Description No.

Merck Press Release, “FDA Approves Merck’s NOXAFIL 2160 (posaconazole) Delayed-Release Tablets,” 11/26/2013. Merck Press Release, “FDA Approves Merck’s NOXAFIL 2161 (posaconazole) Injection (18mg/mL) for Intravenous Use,” 3/14/2014. 2162 NDA Approval Letter from FDA, re Noxafil Intravenous Infusion 2163 NDA Approval Letter from FDA, re Noxafil Oral Suspension 2164 NDA Approval Letter from FDA, re Noxafil Tablets Grabowski, H., et al., Returns on Research and Development for 1990s New Drug Introductions, Pharmacoeconomics, 20, Supp. 3, 11-29 2165 (2002) 2166 MERCK438_0002086 2167 MERCK438_0003164 2168 MERCK438_0045748 2169 MERCK438_0045749 2170 MERCK438_0045758 2171 MERCK438_0090418 2172 MERCK438_0112310 2173 Eon Labs FDA Approval Letter re: Cyclosporine Capsules 2000 Paul Heng, et al., Role of Surfactant on Drug Release From Tablets, 2174 Drug Dev. Indust. Pharm., 16(6), 951-962 (1990) Jae-Young Jung, et al., Enhanced Solubility and Dissolution Rate of Itraconazole by a Solid Dispersion Technique, Int. J. Pharm., 187, 209- 2175 218 (1999) 2176 MERCK438_0012191 2177 MERCK438_0024023-024 2178 MERCK438_0080144 2179 MERCK438_0086899 2180 Drugs@FDA, Sandimmune Approval History Kaneto Uekama, Cyclodextrins in Drug Carrier Systems, CRC Crtical 2181 Rev. Ther. Drug Carrier Sys., (3)1, 1-40 (1987) 2182 U.S. Patent Application No. 2003/0225104 (Hayes) 2183 MERCK438_0021813 Cumpston et al., “Superior Serum Concentrations with Posaconazole Delayed-Release Tablets Compared to Suspension Formulation in Hematological Malignancies,” Antimicrobial Agents and 2184 Chemotherapy, 59 (8) (2015) 9

Exhibit Description No.

Irie, T.I. and Uekama, K. , “Pharmaceutical Applications of Cyclodextrins. III. Toxicological and Safety Evaluation,” J. Pharm. 2185 Sci., 86 (2) (1997) Karthaus, M., “Prophylaxis and Treatment of Invasive Aspergillosis with Voriconazole, Posaconazaole and Capsofungin – Review of 2186 Literature,” Eur. J. Med. Res., 16:145-452 (2011) 2187 MERCK438_0045738 2188 MERCK438_0045740-745 2189 MERCK438_0046735 2190 IMS Data Robert Bellantone, et al., A Method to Predict the Equilibrium Solubility of Drugs in Solid Polymers near Room Temperature Using 2191 Thermal Analysis, J. Pharm. Sci., 101(12) 4549 – 4558 (2012) Gary Liversidge & K. Cundy, Particle Size Reduction for Improvement of Oral Bioavailability of Hydrophobic Drugs: I. Absolute Oral Bioavailability of Nanocrystalline Danazol in Beagle Dogs, Intl. J. 2192 Pharm., 125, 91-97 (1995) 2193 U.S. Patent No. 6,045,829 (Liversidge et al.) 2194 Physician’s Desk Reference, 34th Ed., 1980 2195 Physician’s Desk Reference, 45th Ed., 1991 2196 Astellas Annual Report 2013 (Excerpt) 2197 Astellas Annual Report 2015 (Excerpt) 2198 Astellas Annual Report 2016 (Excerpt) 2199 Gilead 10-k 2015 (Excerpt) 2200 Gilead 10-k 2016 (Excerpt) 2201 Merck Financial Highlights, 2016 Quarter Four (Excerpt) 2202 Merck 10-K 2011 (Excerpt) 2203 Merck 10-K 2012 (Excerpt) 2204 Merck 10-K 2013 (Excerpt) 2205 Merck 10-K 2014 (Excerpt) 2206 Merck 10-K 2015 (Excerpt) 2207 Pfizer, Inc. 2004 Financial Report (Excerpt) 2208 Pfizer, Inc. 2005 Financial Report (Excerpt) 2209 Pfizer, Inc. 2006 Financial Report (Excerpt) 2210 Pfizer, Inc. 2007 Financial Report (Excerpt) 2211 Pfizer, Inc. 2008 Financial Report (Excerpt)

Exhibit Description No.

2212 Pfizer, Inc. 2009 Financial Report (Excerpt) 2213 Pfizer, Inc. 2010 Financial Report (Excerpt) 2214 Pfizer, Inc. 2011 Financial Report (Excerpt) 2215 Pfizer, Inc. 2012 Financial Report (Excerpt) 2216 Pfizer, Inc. 2013 Financial Report (Excerpt) 2217 Pfizer, Inc. 2014 Financial Report (Excerpt) 2218 Pfizer, Inc. 2015 Financial Report (Excerpt) Pfizer Press Release, Pfizer Reports Fourth And Full-Year 2016 2219 Results, Provides 2017 Financial Guidance (Excerpt) Lipinski et al., Experimental and Computational Approaches to Estimate Solubility and Permeability in Drug Discovery and 2220 Development Settings, Adv. Drug Delivery Rev., 46, 3-25 (1997) 2221 Berge S. et al., Pharmaceutical Salts, J. Pharm. Sci., 66(1): 1-15 (1977) Roger Fons, et al., Rates of Rewarming, Heart and Respiratory Rates and Their Significane for Oxygen Transport During Arousal from Torpor in the Smallest Mammal, The Estruscan Shrew Suncus 2222 Etruscus, J. Exp. Biol., 200, 1451-1458 (1997) Asier Larramendi, Shoulder Height, Body Mass and Shape 2223 Proboscideans, Acta Palaeontol., 61(3) 537-574 (2016) 2224 April 13, 2017 email to Board

Respectfully submitted,

AXINN, VELTROP & HARKRIDER LLP

Date: April 19, 2017 By: / Jeremy Lowe / Jeremy Lowe, Reg. No. 48,085 Axinn, Veltrop & Harkrider LLP 90 State House Square Hartford, CT 06002 Phone: (860) 275-8100 Fax: (860) 275-8101

Customer No. 067272

Attorney for Patent Owner Mayne Pharma International Pty Ltd.

CERTIFICATE OF SERVICE

Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on April 19, 2017, a true and

accurate copy of PATENT OWNER’S UPDATED EXHIBIT LIST and Exhibit 2063 was served via electronic mail by agreement of the parties, on the following counsel of record for

Petitioner:

Jane M. Love, Ph.D.: [email protected] Robert W. Trenchard: [email protected] Gibson, Dunn & Crutcher LLP 200 Park Avenue New York, NY Telephone: 212-351-3922

Dated: April 19, 2017 / Jeremy Lowe / Jeremy Lowe Reg. No. 48,085