In Support of Motion for Admission Pro Hac Vice [Reserved] [Reserved] Declaration of Martin Christopher Davies in Support of Patent Owner’s Preliminary Response (“Davies”) Martyn Christopher Davies, Curriculum Vitae Xie et al., “Large-Scale Production, Purification and Crystallization of Wild-Type Adeno-Associated Virus-2,” 122 J. Virol.

Wright et al., “Identification of Factors that Contribute to Recombinant AAV2 Particle Aggregation and Methods to Prevent Its Occurrence during Vector Purification and Formulation,” 12 Molecular Therapy 171 (July 2005) A.E.

Konz et al. “Development of a Purification Process for Adenovirus: Controlling Virus Aggregation to Improve the Clearance of Host Cell DNA,” 21 Biotechnol.

466 (2005) (“Konz”) Stipulation and Order to Amend Case Schedule, Genzyme Corp. et al. v. Novartis Gene Therapies et al., C.A.

U.S. Patent No. 9,051,542 Exhibit Description 2014 Order Denying Plaintiffs’ Motion for Leave to File the Second Amended Complaint, Genzyme Corp. et al. v. Novartis Gene Therapies et al., C.A.

In Support of Motion for Admission Pro Hac Vice Declaration of Martin Christopher Davies in Support of Patent Owner’s Preliminary Response (“Davies”) Martyn Christopher Davies, Curriculum Vitae Xie et al., “Large-Scale Production, Purification and Crystallization of Wild-Type Adeno-Associated Virus-2,” 122 J. Virol.

Wright et al., “Identification of Factors that Contribute to Recombinant AAV2 Particle Aggregation and Methods to Prevent Its Occurrence during Vector Purification and Formulation,” 12 Molecular Therapy 171 (July 2005) A.E.

Konz et al. “Development of a Purification Process for Adenovirus: Controlling Virus Aggregation to Improve the Clearance of Host Cell DNA,” 21 Biotechnol.

466 (2005) (“Konz”) Stipulation and Order to Amend Case Schedule, Genzyme Corp. et al. v. Novartis Gene Therapies et al., C.A.

U.S. Patent No. 9,051,542 Exhibit No. 2014 2015 2016 Description Order Denying Plaintiffs’ Motion for Leave to File the Second Amended Complaint, Genzyme Corp. et al. v. Novartis Gene Therapies et al., C.A.

Exhibit Description Ex. 1012 Clark, K., Recent advances in recombinant adeno-associated virus vector production, Kidney Int’l, Vol.

), Rational Design of Stable Protein Formulations: Theory and Practice, Vol.

Exhibit Description Ex. 1023 Joint Claim Construction Brief, Case Number, C.A.

In Director Vidal’s June 21, 2022 Guidance on Discretionary Denials, she stated that “the PTAB will not discretionarily deny institution of an IPR or PGR in view of parallel district court litigation where a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition.” Director’s Interim Guidance at 7.1 In the interest of efficiency, Petitioner has filed a Sotera stipulation (Ex. 1030) in the related litigation in order to moot the Fintiv issues raised by Patent Owner (see POPR at 61-67).

Respectfully Submitted By: / John D. Livingstone / John D. Livingstone Reg. No. 59,613 Lead Counsel for Petitioner Novartis Gene Therapies, Inc., and Novartis Pharmaceuticals Corporation