ABBVIE, INC. for ABBVIE INC.

Taxation/Internal Revenue Code TAX

HImplementation of H.R. 1, Bill to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (bill formerly known as the Tax Cuts and Jobs Act) Draft legislation relating to economic activity in Puerto Rico

Contacted: HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); Vice President of the U.S.; SENATE; Council of Economic Advisers (CEA)

Bills named: H.R. 1 (115th)

Medicare/Medicaid MMM

S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit manag S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

Contacted: Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Council of Economic Advisers (CEA); Vice President of the U.S.; SENATE

Bills named: S. 1348 (115th), S. 637 (115th)

Budget/Appropriations BUD

S. 3158: Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes

Contacted: Health & Human Services, Dept of (HHS); Vice President of the U.S.; SENATE; Council of Economic Advisers (CEA); HOUSE OF REPRESENTATIVES

Bills named: S. 3158 (115th)

Trade (domestic/foreign) TRD

Trade Agreements and related policy issue International intellectual property and market access policy issues Pricing and reimbursement policy issues Canada intellectual property and market access policy issues NAFTA policy issues Korea Trade Agreement (KORUS) policy issues

Contacted: Vice President of the U.S.; Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; Council of Economic Advisers (CEA)

Copyright/Patent/Trademark CPT

H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 974 Amendment: Hatch-Waxman Integrity Act of 2018 - Provisions related to inter partes review process S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Draft legislation related to notification of agreements to the FTC and DOJ Bayh-Dole march-in rights policy issues

Contacted: Vice President of the U.S.; SENATE; HOUSE OF REPRESENTATIVES; Council of Economic Advisers (CEA); Health & Human Services, Dept of (HHS)

Bills named: S. 1390 (115th), S. 974 (115th), H.R. 5340 (115th), S. 2601 (115th), H.R. 4117 (115th), S. 124 (115th)

Health Issues HCR

H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5353; Leonard Lance, Eliminating Opioid Infectious Diseases Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pri S. 2312: HELP Act - Provisions related to 340B progr S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B prog S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issue Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Contacted: Council of Economic Advisers (CEA); SENATE; Vice President of the U.S.; Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES

Bills named: S. 204 (115th), S. 2453 (115th), S. 2312 (115th), H.R. 5353 (115th), H.R. 5247 (115th), H.R. 5687 (115th), S. 2589 (115th), H.R. 5598 (115th), S. 974 (115th), S. 1131 (115th), H.R. 6071 (115th), H.R. 6142 (115th), H.R. 4710 (115th), H.R. 2212 (115th)