NOVARTIS for NOVARTIS

Budget/Appropriations BUD

Funding for FDA - FY 2026 Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2026 FY 2026 President's Budget Request Inflation Reduction Act of 2022 (P.L. 117-169) Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026 Federal Budget Funding for National Institutes of Health - FY 2026 Appropriations H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); SENATE; White House Office; Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP)

Bills named: H.R. 1 (119th)

Copyright/Patent/Trademark CPT

S. 43: Skinny Labels, Big Savings Act S. 1041: Affordable Prescriptions for Patients Act S. 1095: Stop STALLING Act S. 1096: Preserve Access to Affordable Generics and Biosimilars Act S. 1097: Interagency Patent Coordination and Improvement Act of 2025 S. 2276/HR. 3269: Eliminating Thickets to Increase Competition Act (ETHIC Act) Biopharmaceutical innovation policy issues Bayh-Dole march-in rights policy issues Patent thicket policy issues Patent eligibility policy issues H.R. 3152: Patent Eligibility Restoration Act of 2025 (PERA) H.R. 3160: Promoting and Respecting Economically Vital American Innovation Leadership Act (PREVAIL Act)

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: U.S. Trade Representative (USTR); SENATE; Patent & Trademark Office (PTO); Commerce, Dept of (DOC); HOUSE OF REPRESENTATIVES

Bills named: S. 2276 (119th), H.R. 3152 (119th), H.R. 3269 (119th), S. 1041 (119th), S. 1095 (119th), H.R. 3160 (119th), S. 43 (119th), S. 1096 (119th), S. 1097 (119th)

Health Issues HCR

340B Drug Discount Program - Program Implementation & Oversight 340B PATIENTS Act of 2024 340B Drug Discount Program - RFI for SUSTAIN 340B Act HR. 5256 - 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act(340B ACCESS Act) To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program 340B drug discount program rebate and policy issues 340B rebate pilot program Accelerated Approval Breast Cancer Research Breast Cancer Diagnostics H.R.3037, Access to Breast Cancer Diagnostic Act of 2025 S.1500, Access to Breast Cancer Diagnostic Act of 2025 Alternative Funding Programs Supply Chain Integrity and Traceability PBM Reform Modernizing and Ensuring PBM Accountability (MEPA) Act Coverage of Accelerated Approval Products Drug Benefit Design Orphan Drug Issues H.R.946: ORPHAN Cures Act S.932/H.R. 1262: Give Kids a Chance Act of 2025 Innovation in Pediatric Drugs Act S.864: HELP Copays Act Reimbursement and Coverage of Innovative Products Lower Costs, More Transparency Act Lower Costs, More Cures Act Medicare Part B Physician-Administered Products Patient Cost-Sharing and Smoothing Step Therapy Support of Patient Premiums and Cost-Sharing Obligations Value-based Contracting and Communications H.R. 2214: DRUG Act User fee policy issues Pharmacy Benefit Manager reform and policy issues Drug cost and pricing policy issues Drug importation policy issues FDA regulatory approval authority policy issues Competition policy issues Clinical trial diversity policy issues Patient assistance program policy issues Drug shortages policy issues Artificial intelligence policy issues IRA price negotiation expansion policy issues Rare Pediatric Disease Priority Review Voucher program policies SUSTAIN RFI/discussion draft Most Favored Nation (MFN) policy MAHA Commission Report - Make Our Children Healthy Again Executive Order: Delivering Most-Favored Nation Prescription Drug Pricing to American Patients Executive Order: Lowering Drug Prices by Once Again Putting Americans First Presidential Memoranda: Memorandum for the Secretary of Health and Human Services the Commissioner of Drugs - Addressing Misleading Direct-to-Consumer Prescription Drug Advertisements

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: Food & Drug Administration (FDA); White House Office; Health & Human Services, Dept of (HHS); Congressional Budget Office (CBO); Treasury, Dept of; SENATE; Executive Office of the President (EOP); U.S. Trade Representative (USTR); Commerce, Dept of (DOC); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 1262 (119th), H.R. 3037 (119th), S. 932 (119th), H.R. 2214 (119th), S. 864 (119th), S. 1500 (119th), H.R. 5256 (119th), H.R. 946 (119th)

Medicare/Medicaid MMM

H.R. 950: Saving Seniors Money on Prescriptions Act Inflation Reduction Act of 2022 (P.L. 117-169) implementation policy issues S. 832/H.R. 1492: Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 H.R.1672: Maintaining Investments in New Innovation Act or the MINI Act of 2025 Part D redesign and policy issues including non-interference and rebates policy issues Part B policy issues Drug cost and pricing policy issues Medicare rebate policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues CMS IPAY Guidance on the Medicare Drug Price Negotiation Program IPAY and Maximum Fair Prices policy issues Medicaid rebate policy issues

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: SENATE; Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); White House Office; HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Congressional Budget Office (CBO); Executive Office of the President (EOP)

Bills named: S. 832 (119th), H.R. 950 (119th), H.R. 1492 (119th), H.R. 1672 (119th)

Taxation/Internal Revenue Code TAX

Domestic and International Tax Policy Issues Research & Development Tax Credit Reforms Foreign Direct Investment Expensing of R&D Expenditures H.R. 2425 - Unfair Tax Prevention Act of 2025 Tax Cuts and Jobs Act, PL 115-97 H.R. 1: One Big Beautiful Bill Act (P.L. 119-21)

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 1 (119th), H.R. 2425 (119th)

Trade (domestic/foreign) TRD

Tariff policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues International Pharmaceuticals Pricing and reimbursement policy issues Pharmaceutical manufacturing policy and investment issues Supply chain policy issues WTO TRIPS waiver policy issues China outbound investment policy issues US Swiss Trade Agreement US Trade Policy Sec. 232 pharmaceutical tariffs

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: U.S. Trade Representative (USTR); SENATE; Executive Office of the President (EOP); Commerce, Dept of (DOC); Patent & Trademark Office (PTO); White House Office; HOUSE OF REPRESENTATIVES; Treasury, Dept of; Health & Human Services, Dept of (HHS)

Labor Issues/Antitrust/Workplace LBR

Anti-Trust Reform

Foreign entity interest: Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.

Contacted: SENATE; HOUSE OF REPRESENTATIVES