NOVARTIS for NOVARTIS

Budget/Appropriations BUD

FDA Appropriations funding for Generic Drugs Certified Importer Program (CIP) FY 2016 Labor HHS Appropriations Bill Reconciliation Gx Drug Labeling Biosimilars

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

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 Trans-Pacific Partnership FTA Sub-standards Medicines Quality of Medicines . Trade Promotion Authority . Trans-pacific Partnership . Trans Atlantic Trade and Investment Partnership International Market Access and Intellectual Property Issues Biopharmaceutical Innovation Policies Colombia Intellectual Property Regulatory Cooperation

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

Taxation/Internal Revenue Code TAX

ACA Pharmaceutical Industry Fee Exclusions Anti-Inversion Tax H.R.3618 - Orphan Drug Fairness Act S.1906 - Orphan Drug Fairness Act Medical Device Tax Repeal & Suspension Section 385 Tax Regulation H.R.2315 - Mobile Workforce State Income Tax Simplification Act of 2015

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

Bills named: H.R. 3618 (114th), S. 1906 (114th), H.R. 2315 (114th)

Copyright/Patent/Trademark CPT

HR3116 MODDERN Cures Act of 2013 S.632 STRONG Patents Act of 2015 HR.9 Innovation Act S.1137 PATENT Act Data Exclusivity Trade Secrets Intellectual Property Biopharmaceutical Innovation Policy Issues Biologics Data Protection Issues Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO Neonates BPCIA Hatch-Waxman Patents

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

Bills named: H.R. 3116 (114th), S. 632 (114th), H.R. 9 (114th), S. 1137 (114th)

Health Issues HCR

S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 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 Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information

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

Bills named: S. 481 (114th), S. 2615 (114th), H.R. 4784 (114th), H.R. 2841 (114th), H.R. 6 (114th), H.R. 351 (114th), H.R. 5182 (114th), S. 2041 (114th)

Medicare/Medicaid MMM

Biosimilars Medicare Part D Drug Pricing Part B CMMI Part B Demonstration Project Generics Innovative Pharmaceuticals

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