U.S. Patent No. 9,220,631 and/or for which the probative value to any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

U.S. Patent No. 9,220,631 trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

U.S. Patent No. 9,220,631 trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

U.S. Patent No. 9,220,631 trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

U.S. Patent No. 9,220,631 any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

FRE 403: The exhibit’s probative value to any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

FRE 403: The exhibit’s probative value to any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

FRE 403: The exhibit’s probative value to any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

FRE 403: The exhibit’s probative value to any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

FRE 403: The exhibit’s probative value to any ground upon which trial was instituted is substantially outweighed by the danger of unfair prejudice, confusing the issues, undue delay, wasting time, or needlessly cumulative evidence.

Regeneron Pharmaceuticals, Inc. files this motion for Pro Hac Vice admission under 37 C.F.R § 42.10(c), as authorized in the Notice of Filing Date Accorded to Petition, Paper No. 3.

Petitioner respectfully requests that the Board recognize Petra Scamborova as counsel pro hac vice during this proceeding.

Further, counsel for patent owner does not oppose Dr. Scamborova appearing as pro hac vice during this proceeding.

Affidavit or Declaration of Individual Seeking to Appear This motion for Pro Hac Vice Admission is accompanied by the Declaration of Dr. Petra Scamborova (Ex. 1095), as required by authorization of the Board.

Dated: December 22, 2021 Respectfully submitted, /Elizabeth Stotland Weiswasser/ Elizabeth S. Weiswasser (Reg. No. 73,760) Anish R. Desai (Reg. No. 73,760) Natalie Kennedy (Reg. No. 68,511) Andrew Gesior (Reg. No. 76,588) Weil, Gotshal & Manges LLP 767 Fifth Avenue New York, NY 10153

William G. James (Reg. No. 55,931) Goodwin Procter LLP 1900 N Street, N.W.

(2012) (“Keane”) FDA Alerts Health Care Professionals of Injection Risk from Repackaged Avastin Intravitreal Injections, U.S. Food and Drug Administration (Sep. 1, 2011), https://web.archive.org/web/20110901180651/https://www.fda.gov/Dr ugs/DrugSafety/ucm270296.htm (last accessed Nov. 10, 2020) (“FDA Alert”) Ex. 2027 FDA Guidance for Industry – Q1A (R2) Stability Testing of New Drug Substances and Products (2003) Ex. 2028 Hultman, et al., The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide, Pharmaceutical Engineering, January/February 2007, 27(1):1-6 (“Hultman”) Ex. 2029 Nitin Rathore, et al., Characterization of Protein Rheology and Delivery Forces for Combination Products, JOURNAL OF PHARMACEUTICAL SCIENCES, 101(12):4472-80 (Dec. 2012) (“Rathore 2012”) Ex. 2030 Tracy Chang, et al., Cell and Protein Compatibility of Parylene-C Surfaces, Langmuir (2007) (“Chang”) Ex. 2031 Marta Kaminska, et al., Interaction of parylene C with biological objects, Acta Bioeng Biomech.

PRODUCTS Q1A(R2) GUIDELINE (Feb. 6, 2003) Exhibit Description Ex. 2049 Glen Petrie, The Need for Specificity in Accelerated Aging, Medical Device & Diagnostic Industry (2006) (“Petrie”) Ex. 2050 2020-01318 IPR, Paper No. 16, Petitioner’s Unopposed Motion to Terminate the Proceeding Ex. 2051 2020-01317 IPR, Paper No. 13, Petitioner’s Reply Regarding 35 U.S.C. §§ 314(a), 325(d) Ex. 2052 Regeneron Pharmaceuticals, Inc.’s First Amended Complaint (DI87), Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG et al., 1:20- cv-05502 (S.D.N.Y. January 25, 2021) Ex. 2053 Ex. 2054 Ex. 2055 2020-01317 IPR, Paper No. 19, Petitioner’s Unopposed Motion to Withdraw its Request for Rehearing of the Board’s Decision Denying Inter Partes Review FDA Compliance Program Guidance Manual, Chapter 56 – Drug Quality Assurance, STERILE DRUG PROCESS INSPECTIONS (Sept. 11, 2015) FDA Guidance for Industry, for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (1994) Ex. 2056 European Medicines Agency, Macugen: European Public Assessment Report – Scientific Discussion (May 31, 2007) Ex. 2057 Docket Text- Minute Entry for proceedings held before Magistrate Judge Hummel: Status Conference held on 6/11/2021, Novartis Pharma AG, et al. v. Regeneron Pharmaceuticals, Inc., 1:20-cv- 00690-TJM-CFH (N.D.N.Y. June 11, 2021) Ex. 2058 Letter from Jessica Falk to Novartis in Response to May 10 Letter Redacted, dated May 14, 2021 Ex. 2059 2020-01317 IPR, Ex. 3004, April 16, 2021 Email from Brian Ferguson to Board re Withdrawal of POP Consideration Exhibit Description Ex. 2060 Uniform Pretrial Scheduling Order (DI67), Enthone Inc. v. Moses Lake Industries, Inc., 1:13-CV-1054 (N.D.N.Y. August 14, 2014) Ex. 2061 Uniform Pretrial Scheduling Order (DI22), Enthone Inc. v. BASF Corporation, 1:15-CV-233 (N.D.N.Y. June 4 2015) Ex. 2062 Declaration of Jeffrey Salling In Support of Novartis’s Patent Owner Preliminary Response Ex. 2063 Lucentis Project Review_2011 10 05a.pptx [FILED UNDER SEAL] Ex. 2064 RFB002, RP01030A, Risk assessment: Changes in starting material and manufacturing process between registration stability and process validation campaigns [FILED UNDER SEAL] Ex. 2065 Metadata Report for Ex. 2063 Ex. 2066 Lucentis® PFS TRD SubTeam Meeting Minutes (Oct. 11, 2011)

NOVITC(US)00697489 [Filed Under Seal] Ex. 2171 Ex. 2172 Ex. 2173 NOVITC(US)00718202 [Filed Under Seal] Intentionally omitted Ex. 2174 World Health Organization, Guidelines on Packaging for Pharmaceutical Products, WHO Technical Report Series, No. 902 (2002) Ex. 2175 Michael J. Akers, Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality (2010) (“Akers 2010”) Ex. 2176 Katia Boven et al., The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes, Kidney Int’l (2005), 67:2346-2353 (“Boven 2005”) Stelios T. Tzannis et al., Irreversible inactivation of interleukin 2 in a pump-based delivery environment, PNAS (May 1996), 93:5460-5465 (“Tzannis 1996”) Ingrid Markovic, Risk Management Strategies for Safety Qualification of Extractable and Leachable Substances in Therapeutic Biologic Protein Products, Extractables & Leachables (June 2009), 96-101 (“Markovic 2009”) Ingrid Markovic, Regulatory Perspective on Safety Qualification of Extractables and Leachables, U.S. Food & Drug Admin.

(2014), http://dx.doi.org/10.1155/2014/989501 Florian Baudin et al., Association of Acute Endophthalmitis with Intravitreal Injections of Corticosteroids or Anti-Vascular Growth Factor Agents in a Nationwide Study in France, JAMA Oph.

McCuen, Silicone Oil in Vitreoretinal Surgery, Ryan’s Retina 2231 (Schachat, A.P., et al eds., 2006) Ex. 2318 Michael S. Ip et al., Intravitreal Triamcinolone for the Treatment of Macular Edema Associated with Central Retinal Vein Occlusion, Arch.

Celltrion, Inc. hereby updates its Mandatory Notices pursuant to 37 C.F.R. § 42.8 to add related matters.

Hospira, Inc., a third party, filed IPR2017-00737 and IPR2017-00739 challenging the ’549 patent on grounds that are different from those asserted in the petition for the instant proceeding.

In IPR2017-01960, Samsung Bioepis Co., Ltd., a third party, has asserted that claims 1-17 of the ’549 patent are obvious based on grounds that are different than those in this Petition.

Samsung Bioepis has also filed a petition for IPR of the ’441 patent in IPR2018-00192.

The ’549 patent and the related ’441 patent are at issue in the following litigations: Celltrion, Inc. et al. v. Genentech, Inc. et al., No. 18-cv-274 (N.D. Cal), appeal docketed, No. 18-2160 (Fed. Cir. July 16, 2018); Genentech, Inc. et