Intas Pharmaceuticals, Ltd. et al. v. Atossa Therapeutics, Inc. - IPR2025-00799

Order: Conduct of the Proceeding 37 C.F.R. sec. 42.5

Exhibit 3001

Petitioner's Unopposed Motion to Withdraw Backup Counsel

Order Denying Director Review of Institution Decision

EX2030 - Declaration of Stephen G. Davies, DPhil

EX2031 - Transcript of January 9, 2026 Deposition of William Mayo, Ph.D.

EX2032 - Transcript of January 16, 2026 Deposition of Jason McConville, Ph.D.

EX2033 - Transcript of January 20, 2026 Deposition of Ron Bihovsky, Ph.D.

EX2034 - S.R. Logan, The Origin and Status of the Arrhenius Equation 4 J. CHEM. ED. 279 (1982)

EX2035 - Edina Vranić, Recent Advances in the Identification and Prediction of Polymorphs 3 BOSNIAN J. OF BASIC MED. SCIENCES 32 (2003)

EX2036 - Trevor Laird, Polymorphism and Impurities 8 ORGANIC PROCESS RESEARCH & DEVELOPMENT 301 (2004)

EX2037 - Masaki Okamoto, et al., The Effects of Impurities on Crystallization of Polymorphs of a Drug Substance AE1-923, 37 J. OF CHEM. ENGINEERING OF JAPAN 1224 (2004)

EX2038 - Eun Hee Lee, A Practical Guide to Pharmaceutical Polymorph Screening & Selection, 9 ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES 164 (2014)

EX2039 - H. Sharma et al., Preferential Nucleation during Polymorphic Transformations, NATURE SCIENTIFIC REPORTS (2016)

EX2040 - Priyanka Maurya et al., Pharmaceutical Polymorphism: The Phenomenon Affecting the Performance of Drug and an Approach to Enhance Drug Solubility, Stability and Bioavailability, WORLD JOURNAL OF PHARMACEUTICAL SCIENCES (2016)

EX2041 - John Spencer Evans, Polymorphs, Proteins, and Nucleation Theory: A Critical Analysis, 7 MINERALS 62 (2017)

Patent Owner's Response

EX2042 - International Patent Application No. WO 2023/137044A2

EX2043 - Declaration of Sayem Osman

EX2050 - EX2050 - William E. Brown & Margareth R. Marques, USP and Dissolution—20 Years of Progress, DISSOLUTION TECHNOLOGIES (2014)

Patent Owner Atossa's Objections to Evidence

Petitioner's Updated Exhibit List

Expert Declaration of William Mayo, Ph.D. Adopting the Opinions of Steven Miller, Ph.D.

Petitioner's Sur-Reply in Opposition to Patent Owner's Motion for Discovery

ORDER Granting Patent Owner’s Motions for Pro Hac Vice Admission of Jacob M. Berman, Han Xu, and Hayley R. LeBlanc 37 C.F.R. § 42.10

ORDER Conduct of the Proceeding 37 C.F.R. § 42.5

Patent Owner’s Reply to Petitioner's Opposition to Patent Owner’s Motion for Additional Discovery

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Han Xu

EX2028 - Declaration of Han Xu

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Hayley R. LeBlanc

EX2029 - Declaration of Hayley R. LeBlanc

Patent Owner's Supplemental Mandatory Notice

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Jacob M. Berman

EX2027 - Declaration of Jacob M. Berman

Notice of Deposition of William Mayo, Ph.D.

Notice of Deposition of Jason McConville, Ph.D.

Notice of Deposition of Ron Bihovsky, Ph.D.

Petitioner's Opposition to Patent Owner's Motion for Discovery

Patent Owner's Motion to Seal

Patent Owner's Motion for Additional Discovery (SEALED)

Patent Owner's Motion for Additional Discovery (REDACTED)

EX2023 - U.S. Patent No. 12,245,997

EX2024 - December 6, 2025 Collection of Email Communications with Intas's Counsel

EX2025 - Declaration of Sayem Osman

Order: Authorizing Mot. Additional Discovery

Petitioner's Response to Patent Owner's Request for Director Review

Patent Owner Atossa's Objections to Evidence

Patent Owner's Request for Director Review

Ex. 3102 Counsel email for Authorized Response

Institution Decision: Grant

Order: Scheduling Order

Director Discretionary Decision: Refer

Patent Owner's Authorized Reply to Petitioner's Response to Patent Owner's Request for Discretionary Denial

Email Correspondence

Petitioner's Response to Patent Owner's Request for Discretionary Denial of Institution

Chen P. et al. (2018)

Goetz MP et al. (2017)

Takebe N et al. (2021)

Patent Owner's Preliminary Response

EX2001 - ATOSSA THERAPEUTICS, INC. QUARTERLY REPORT FORM 10-Q for the Quarterly Period Ended March 31, 2025

EX2002 - Atossa Therapeutics Proposes Potentially Groundbreaking Study Aimed at Reducing Interval Breast Cancer in High-Risk Women at AACR 2025 (April 29, 2025)

EX2003 - Atossa Therapeutics Announces Plans to Pursue Metastatic Breast Cancer Indication for (Z)-Endoxifen and Continued Engagement with FDA on Additional Indications (March 11, 2025)

EX2004 - Financials – Intas Pharmaceuticals Ltd.

EX2005 - Atossa Therapeutics Announces Issuance of Key U.S. Patent Covering Endoxifen (March 8, 2022)

EX2006 - Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients, NCT06608641 (Last Updated March 17, 2025)

EX2007 - Declaration of Sayem Osman

EX2008 - Atossa Covenant Not to Sue

EX2009 - Atossa Therapeutics Announces Full Results from Phase 2 KARISMA-Endoxifen Study Demonstrating Statistically Significant Reductions in Mammographic Breast Density (Dec. 11, 2024)

EX2010 - Atossa Therapeutics Announces First Quarter 2025 Financial Results and Provides a Corporate Update (May 13, 2025)

EX2011 - Intas Pharmaceuticals, Limited v. Atossa Therapeutics, Inc., PGR2023-00043, EX1030 (Excerpt)

EX2012 - Breast Center Year in Review, An Unmet Need in HR-Positive Endocrine-Resistant Breast Cancer

EX2013 - ATOSSA THERAPEUTICS, INC. ANNUAL REPORT FORM 10-K for the Fiscal Year Ended December 31, 2024

EX2014 - U.S. Patent No. 11,572,334

EX2015 - Intas Requirements for Resolving Disputes with Atossa (FILED UNDER SEAL)

EX2016 - Default Protective Order

EX2017 - Intas Pharmaceuticals, Limited v. Atossa Therapeutics, Inc., PGR2025-00043, Pap.2 (Apr. 3, 2025)

EX2018 - Intas Pharmaceuticals, Limited v. Atossa Therapeutics, Inc., PGR2023-00043, Pap.1 (Aug. 18, 2023)

EX2019 - Rishab Gupta & Swarndeep Singh, Endoxifen Approval for Bipolar in India, A Premature or a Pragmatic Decision?, 43(1) J. CLINICAL PSYCHOPHARMACOLOGY 3 (2023)

EX2020 - Zonalta, Why Zonalta?

EX2021 - Atossa Therapeutics Granted Additional Patent Protection for Endoxifen (August 28, 2024)

EX2022 - Declaration of Megan Raymond

Patent Owner's Motion to Seal

Patent Owner's Discretionary Denial Request [FILED UNDER SEAL]

Patent Owner's Discretionary Denial Request [REDACTED]

Notice: Notice filing date accorded

Power of Attorney and Designation of Lead and Back-Up Counsel

Patent Owner's Mandatory Notices

USPN 11,261,151

File history of USPN 11,261,151

WO 2017/070651 (Liu)

USPN 9,333,190 (Ahmad)

Fauq (2010)

Ahmad (2010)

Ahmad (2012)

Cole (2002)

Fan (2014)

Urso (2002)

Bunaciu

Excerpts of Handbook of Pharmaceutical Excipients

Stegemann

Benameur

Prescribing Information for Zonalta

Beasley

Evans

Goel

Endoxifen

Krahn

A Focus on Crystallography

Milroy

Supporting information to Milroy

Ali

Supporting information to Fauq

Elkins

Shargel

Wieckhusen

Richardson

Ansel

USP 941

Expert Declaration of Jason McConville, Ph.D.

Expert Declaration of Ron Bihovsky, Ph.D.

Expert Declaration of Steven Miller, Ph.D.

Notice: Power of Attorney

Petition: as filed