NOVARTIS for NOVARTIS

Trade (domestic/foreign) TRD

Free Trade Agreements: - Intellectual Property and Transparency Provisions - Free Trade Agreements Access to Medicines Issues Global Health Issues India, China and Canada IP and market Access Issues Sub-standards Medicines Quality of Medicines International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation The North American Free Trade Agreement - NAFTA Re-negotiation USTR Special 301 Report/National Trade Estimate Trade Policy KORUS

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: Office of Management & Budget (OMB); Commerce, Dept of (DOC); SENATE; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); State, Dept of (DOS); U.S. Agency for International Development (USAID); White House Office; Food & Drug Administration (FDA)

Taxation/Internal Revenue Code TAX

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax Medical Device Tax Repeal & Suspension Section 385 Tax Regulation Tax Reform Orphan Drug Tax Tax Reform Border Adjustment Tax Mobile Workforce Thin Capitalization Rules 163(j) Base Erosion Surtax Interest Deduction

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); Centers For Medicare and Medicaid Services (CMS); U.S. Agency for International Development (USAID); State, Dept of (DOS); SENATE; Commerce, Dept of (DOC); White House Office; U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS)

Copyright/Patent/Trademark CPT

Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents Inter Partes Review at PTO

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: Office of Management & Budget (OMB); SENATE; HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Commerce, Dept of (DOC); Health & Human Services, Dept of (HHS); U.S. Agency for International Development (USAID); U.S. Trade Representative (USTR); White House Office; State, Dept of (DOS)

Health Issues HCR

Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo IPAB Generic Drug Labeling Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Tropical Disease Priority Review Voucher Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017

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: Commerce, Dept of (DOC); White House Office; Health & Human Services, Dept of (HHS); U.S. Agency for International Development (USAID); HOUSE OF REPRESENTATIVES; SENATE; Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); State, Dept of (DOS); Food & Drug Administration (FDA); U.S. Trade Representative (USTR)

Bills named: S. 204 (115th), S. 469 (115th), H.R. 2430 (115th), H.R. 849 (115th), H.R. 2641 (115th), S. 456 (115th)

Medicare/Medicaid MMM

Biosimilars Medicare Part D Drug Pricing Part B Outcomes Based Contracts Generics Innovative Pharmaceuticals Cell and Gene Therapy

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; Office of Management & Budget (OMB); U.S. Trade Representative (USTR); White House Office; State, Dept of (DOS); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; U.S. Agency for International Development (USAID); Health & Human Services, Dept of (HHS); Commerce, Dept of (DOC); Food & Drug Administration (FDA)

Budget/Appropriations BUD

FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2017 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars 2017 Agriculture Appropriations Bill Importation Drug Pricing Value of Meds

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. Agency for International Development (USAID); Food & Drug Administration (FDA); Commerce, Dept of (DOC); U.S. Trade Representative (USTR); SENATE; State, Dept of (DOS); White House Office; Office of Management & Budget (OMB); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS)