Stop Stalling Access to Affordable Medications

H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $830,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act Patent litigation reform issues and issues related to post-grant proceedings at the USPTO Value of intellectual property

Client expense: $970,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act Trade; Supply Chain and Manufacturing; H.R. 4521-United States Innovation and Competition Act of 2021, H. Rept. 117-235 Trade; Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Client expense: $1,170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

IP and Antitrust; H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435- Affordable Prescriptions for Patients Act of 2021 S. 1425- Stop STALLING Act

Client expense: $1,170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883- Stop Stalling Access to Affordable Medications H.R. 2884 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891- Preserve Access to Affordable Generics and Biosimilars Act H.R. 7032- Increasing Transparency in Generic Drug Applications Act of 2022 S. 1425- Stop STALLING Act S. 1435- Affordable Prescriptions for Patients Act of 2021 TRIPS / IP Waiver Issues related to intellectual property, data exclusivity, patent eligibility & patent law reform, and Antitrust;

Client expense: $1,170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $2,578,869 · Firm income: Not reported

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

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 447, National Apprenticeship Act of 2021 H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486/S. 4431, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 5842, Ending the Monopoly of Power Over Workplace Harassment through Education and Reporting (EMPOWER) Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.R. 7151, Ensuring Sound Guidance Act H.R. 7309, Workforce Innovation and Opportunity Act of 2022 H.R. 7701, Wage Theft Prevention and Wage Recovery Act H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant H.J. Res. 100,To provide for a resolution with respect to the unresolved disputes between certain railroads represented by the National Carriers' Conference Committee of the National Railway Labor Conference and certain of their employees H. Con. Res. 119, Providing for a correction in the enrollment of H.J. Res. 100 S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 977, No Oil Producing and Exporting Cartels (NOPEC) Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 2991, Countering Human Trafficking Act of 2021 S. 3311, FTC Integrity Act S. 3847, Prohibiting Anticompetitive Mergers Act of 2022 S. 3889, Employee Rights Act S. 4145, Consumer Protection Remedies Act of 2022 S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Nomination of Jessica Looman to be Administrator of the Wage and Hour Division Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Proposed Rule, Department of Labor; Employee or Independent Contractor Classification under the Fair Labor Standards Act (87 Fed. Reg. 62,218-62,275, Oct. 13, 2022) Proposed Rule, National Labor Relations Board; Standard for Determining Joint-Employer Status Under the National Labor Relations Act (87 Fed. Reg. 54,641-54,663, September 7, 2022) Request for Comments, Internal Revenue Service; Prevailing Wage, Apprenticeship, Domestic Content, and Energy Communities Requirements Under the Act Commonly Known as the Inflation Reduction Act of 2022 (Docket No. IRS-2022-0025, Notice 2022-51, November 30, 2022) Request for Comments, International Trade Administration; Artificial Intelligence Export Competitiveness (87 Fed. Reg. 50,288-50,289, August 16, 2022) Proposed Rule, Department of Defense, General Services Administration, and National Aeronautics and Space Administration; Federal Acquisition Regulation: Use of Project Labor Agreements for Federal Construction Projects (87 Fed. Reg. 51,044-51,052, August 19, 2022) Final Rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (87 Fed. Reg. 73,822-73,886, December 1, 2022) Proposed Rule, Improve Tracking of Workplace Injuries, and Illnesses (87 Fed. Reg. 18,528-18,558, March 3, 2022) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave including paid family and sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; debarment of federal contractors (blacklisting); Equal Employment Opportunity Commission (EEOC) conciliation regulation; the firing of Peter Robb as General Counsel of the National Labor Relations Board (NLRB), and of Alice Stock, Deputy General Counsel of the NLRB; rescission of the joint employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; anticipated overtime regulations under the Fair Labor Standards Act Office of Federal Contract Compliance Programs, Directive (DIR) 2022-01; filing complaints under the National Labor Relations Act; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14036, Promoting Competition in the American Economy; Executive Order 14063, Use of Project Labor Agreements for Federal Construction Projects; President Bidens Path Out of the Pandemic: COVID Action Plan; unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; section 5 of the Federal Trade Commission Act of 1914; efforts to revise the 1995 Bank Merger Competitive Review Gudelines; efforts to modernize enforcement of the antitrust laws regarding mergers; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257)

Client expense: $20,990,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver March in rights

Client expense: $880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Consolidated Appropriations Act of 2023, H.R. 2617 (provisions related to pharmaceuticals and healthcare). H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $480,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Executive Order on Access to Affordable Life-Saving Medications ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.2617: Consolidated Appropriations Act of 2023 ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---H.R.2617: Consolidated Appropriations Act of 2023 ---Implementation of the Inflation Reduction Act (IRA) of 2022 Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Reauthorization of PAHPA Funding for FDA ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---H.R.2617: Consolidated Appropriations Act of 2023 Funding for National Institutes of Health ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2617: Consolidated Appropriations Act of 2023 ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.2617: Consolidated Appropriations Act of 2023 Generic Drug Entry ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---S.4351/H.R. 6973: Enhanced Access to Affordable Medicines Act ---S.4338/H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates Opioid Crisis ---Non-Opioid Analgesics Orphan Drug Issues ---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Orphan Drug Tax Credit Rare Pediatric Disease Priority Review ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Implementation of the Inflation Reduction Act (IRA) of 2022 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy Vaccines and Infectious Diseases ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act ---H.R.9358: Access to Innovative Treatments Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4509 Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Maternal Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---H.R.2617: Consolidated Appropriations Act of 2023 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021 ---S.3810: Countermeasure Injury Compensation Fund Amendment Act ---VICP CICP (Discussion Draft)

Client expense: $3,740,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Compulsory Licensing ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.8152: American Data Privacy and Protection Act ---S.2499: Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act Diversity in Patenting ---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2773: Unleashing American Innovators Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---H.R.5874: Restoring America's Leadership in Innovation Act ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Implementation of the America Invents Act of 2011 ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Patent Litigation Reform Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization Patenting of Humanitarian Technologies ---H.R.5796: Patents for Humanity Act of 2021 United States-Mexico-Canada Agreement (USMCA) ---Mexico Draft Decree Banning Genetically Modified Corn

Client expense: $3,740,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP issues related to the enactment of the drug pricing provisions of the IRA including the so-called "9/13 years, drugs/biologics and orphan drug-related provisions. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) S. 4258/H.R. 7839 (Competition and Transparency in Digital Advertising Act) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003) S. 2992 (American Innovation and Choice Online Act) S. 2710 (Open App Markets Act) H.R. 2617 (legislative vehicle for the Consolidated Appropriations Act FY 2023 with Senate amendment #6552) antitrust-related policy riders

Client expense: Not reported · Firm income: $10,000

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

Support stronger IP and exclusivity protections and enforcement in foreign markets Patent litigation reform issues and issues related to post-grant proceedings at the USPTO H.R.2891, Preserve Access to Affordable Generics and Bosimilars Act H.R.2873, Affordable Prescriptions for Patients through Promoting Competition Act of 2021 H.R.2883, Stop Stalling Access to Affordable Medications H.R.2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.2891, Restoring the America Invents Act

Client expense: $940,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Client expense: $930,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Client expense: $930,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act H.R.5376: The Inflation Reduction Act, Sec. 139301, Prohibiting implementation of rule relating to eliminating the anti-kickback statute safe harbor protection for prescription drug rebates 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $1,908,258 · Firm income: Not reported

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

Support stronger IP and exclusivity protections and enforcement in foreign markets Patent litigation reform issues and issues related to post-grant proceedings at the USPTO H.R.2891, Preserve Access to Affordable Generics and Bosimilars Act H.R.2873, Affordable Prescriptions for Patients through Promoting Competition Act of 2021 H.R.2883, Stop Stalling Access to Affordable Medications H.R.2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.2891, Restoring the America Invents Act

Client expense: $900,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; General issues related to drug pricing; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act; H.R. 7667 - Food and Drug Amendments of 2022; S.4348 - FDASLA Act of 2022 H.R. 7845 - NIH Clinical Trial Diversity Act of 2022; H.R 7032 - Increasing Transparency in Generic Drug Applications Act of 2022; H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Client expense: $910,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521, H. Rept. 117-235 America COMPETES Act of 2022 H.R. 7032, Increasing Transparency in Generic Drug Applications Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act S. 1425, Stop STALLING Act Issues related to the World Trade Organization (WTO) waiver on Trade-related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines

Client expense: $910,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2774, Pride in Patent Ownership Act S. 2891, Restoring the America Invents Act Patent litigation reform issues and issues related to post-grant proceedings at the USPTO Value of intellectual property

Client expense: $2,370,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 447, National Apprenticeship Act of 2021 H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486/S. 4431, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4841, Restoring Justice for Workers Act H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 5842, Ending the Monopoly of Power Over Workplace Harassment through Education and Reporting (EMPOWER) Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.R. 7151, Ensuring Sound Guidance Act H.R. 7309, Workforce Innovation and Opportunity Act of 2022 H.R. 7701, Wage Theft Prevention and Wage Recovery Act H.R. 8295/S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 977, No Oil Producing and Exporting Cartels (NOPEC) Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 3311, FTC Integrity Act S. 3847, Prohibiting Anticompetitive Mergers Act of 2022 S. 3889, Employee Rights Act S. 4145, Consumer Protection Remedies Act of 2022 S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Draft legislation titled Retirement Savings Modernization Act Nomination of Jessica Looman to be Administrator of the Wage and Hour Division Proposed rule on Joint Employer Status Under the Fair Labor Standards Act, (84 Fed. Reg. 14,043-14,061, April 9, 2019) Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Interim final rule on COVID-19 Vaccination and Testing; Emergency Temporary Standard (86 Fed. Reg. 61,402-61,555, November 5, 2021) Advance Notice of Proposed Rulemaking Concerning Heat Injury and Illness Prevention in Outdoor and Indoor Settings (86 Fed. Reg. 59,309-59,326, Oct. 27, 2021) Proposed Amendments to Agriculture Acquisition Regulations (87 Fed. Reg. 9,005-9,021, February 17, 2022) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Final rule on Financial Factors in Selecting Plan Investments (85 Fed. Reg. 72,846-72,885, November 13, 2020) Final rule on Fiduciary Duties Regarding Proxy Voting and Shareholder Rights (85 Fed. Reg. 81,658-81,695, December 16, 2020) Proposed rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (86 Fed. Reg. 57,272-57,304, October 13, 2021) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave including paid family and sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; debarment of federal contractors (blacklisting); contractor blacklisting; Equal Employment Opportunity Commission (EEOC) conciliation regulation; rescission of the joint employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential Wage and Hour Division rulemaking on classification of independent contractors and employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; anticipated overtime regulations under the Fair Labor Standards Act Office of Federal Contract Compliance Programs, Directive (DIR) 2022-01; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14036, Promoting Competition in the American Economy; Executive Order 14063, Use of Project Labor Agreements for Federal Construction Projects; President Bidens Path Out of the Pandemic: COVID Action Plan; unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; efforts to revise the 1995 Bank Merger Competitive Review Gudelines; efforts to modernize enforcement of the antitrust laws regarding mergers; competition in the agriculture marketplace; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257); GAO study on Fiduciary Investment Advice

Client expense: $23,940,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC)

Antitrust Legislation Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver Data Privacy Issues ---H.R.8152: American Data Privacy and Protection Act ---S.2499: Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---H.R.5874: Restoring America's Leadership in Innovation Act ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Implementation of the America Invents Act of 2011 ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Patent Litigation Reform Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility

Client expense: $3,220,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---White House National Biodefense Strategy Biosimilars ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---FY 2022 Continuing Resolution ---H.R.550: Immunization Infrastructure Modernization Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Drug Supply Chain Management ---Healthcare Disparities --- In-Home Administration of Part B Drugs ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---Temporarily Refundable R&D Credit ---TRIPS Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---S.1644: Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies (ADAPT) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment (Discussion Draft) ---Advanced Manufacturing ---Counterfeiting ---Drug Shortages ---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Restrictions on Intellectual Property Rights Drug Pricing ---FY 2023 Appropriations ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Drug Pricing Provisions ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.7900: National Defense Authorization Act for FY 2023 ---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2022 Continuing Resolution ---FY 2023 Appropriations ---H.R.4521: COMPETES Act ---H.R.5376: Inflation Reduction Act of 2022 ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---H.R.7667: The Food and Drug Amendments of 2022 ---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2022 Continuing Resolution ---FY 2023 Appropriations Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Generic Drug Application Review Reforms ---Incentives for Generic Entry Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.7389: Medicaid VBPs for Patients (MVP) Act of 2022 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---Non-Opioid Analgesics ---Transparency Orphan Drug Issues ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.5566 Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2071: Medicare Prescription Drug Price Negotiation Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Inflation Reduction Act of 2022 ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---CMMI Authority ---Drug Pricing Provisions ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---H.R.9127: A bill to amend title XVIII of the Social Security Act to clarify the use of the national coverage determination process under the Medicare program. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3656: Vaccine Access Improvement Act of 2021 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---VICP CICP (Discussion Draft)

Client expense: $3,220,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity Intellectual Property Issues in Response to coronavirus Inter Parties Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act WTO TRIPS Waiver H.R. 5376 - Inflation Reduction Act

Client expense: $850,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

H.R. 5376, Inflation Reduction Act (drug pricing provisions). S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act." Presidents FY23 Budget Request. H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. H.R. 7035, the Biologics Market Transparency Act." H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes. H.R. 1730, the Speeding Therapy Access Today Act of 2021. H.R. 2565, the FDA Modernization Act of 2021. H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021. H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act. H.R. 6963, the Accelerated Approval Integrity Act of 2022. H.R. 6973, the Enhanced Access to Affordable Medicines Act. H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act." H.R. 7032, the Increasing Transparency in Generic Drug Applications Act. Proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and H.R. 3, the "Elijah E. Cummings Lower Drug Costs Now Act." H.R. 19, the "Lower Costs, More Cures Act of 2021." HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy). H.R. 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"). H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including H.R. 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements) and H.R. 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including H.R. 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), H.R. 2831, the "Prompt Approval of Safe Generic Drugs Act," H.R. 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). H.R. 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." H.R. 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). H.R. 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $670,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

Reform of Section 101 of the patent code including the Patent Eligibility Restoration Act, S. 4734. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

Client expense: $70,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) S. 4258/H.R. 7839 (Competition and Transparency in Digital Advertising Act) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003) S. 2992 (American Innovation and Choice Online Act)

Client expense: Not reported · Firm income: $10,000

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE

H.R. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S. 2891, Restoring the America Invents Act Patent litigation reform issues and issues related to post-grant proceedings at the USPTO Value of intellectual property

Client expense: $880,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Antitrust Legislation Bayh-Dole Act Biopharmaceutical Intellectual Property Biosimilars BPCIA Compulsory licenses Data Exclusivity H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 Intellectual Property Issues in Response to coronavirus Inter Partes Review at PTO Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO Patents S.1435, Affordable Prescriptions for Patients Act of 2021 S.225, Competition and Antitrust Law Enforcement Reform Act Section 101 H.R. 2883, the Stop Stalling Access to Affordable Medications H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act

Client expense: $1,790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes H.R.6833: Affordable Insulin Now Act H.R.6963: Accelerated Approval Integrity Act H.R.7008: Pre-approval Information Exchange Act H.R.7032: Increasing Transparency in Generic Drug Applications Act H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act S.4011: Capping Drug Costs for Seniors Act of 2022 H.R.7666: Restoring Hope for Mental Health and Well-Being Act H.R.7667: Food and Drug Amendments of 2022 H.R.7828: To amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 5 years; (PRICED Act) S.4293: Pharmacy Benefit Manager Transparency Act S.4348: A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes; (FDASLA Act) H.R.7995: GOLD CARD Act 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $1,457,755 · Firm income: Not reported

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

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot Prescription Drug User Fee Act (PDUFA) H.R. 4128/S. 2209, VALID Act S. 4293, the Pharmacy Benefit Manager Transparency Act of 2022 Pharmaceutical Innovation, generally;

Client expense: $1,270,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

Issues relating to Intellectual Property protections for Covid-19 treatments and vaccines. H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act. H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2891 Preserve Access to Affordable Generics and Biosimilars Act H.R. 4521 America COMPETES Act of 2022 S. 1435, the Affordable Prescriptions for Patients Act

Client expense: $1,270,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Support stronger IP and exclusivity protections and enforcement in foreign markets Patent litigation reform issues and issues related to post-grant proceedings at the USPTO H.R.2891, Preserve Access to Affordable Generics and Bosimilars Act H.R.2873, Affordable Prescriptions for Patients through Promoting Competition Act of 2021 H.R.2883, Stop Stalling Access to Affordable Medications H.R.2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.2891, Restoring the America Invents Act

Client expense: $900,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill. S.4430, Interagency Patent Coordination and Improvement Act of 2022 introduced by Sens. Durbin, Tillis, and Grassley.

Client expense: $82,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

H.R. 5/S. 393, Equality Act H.R. 7/S. 205, Paycheck Fairness Act H.R. 603/S. 53, Raise the Wage Act of 2021 H.R. 804/S. 248, Family and Medical Insurance Leave (FAMILY) Act H.R. 830, Wage Increase Fairness Act H.R. 842/S. 420, Protecting the Right to Organize Act of 2021 H.R. 1065/S. 1486/S. 4431, Pregnant Workers Fairness Act H.R. 1195, Workplace Violence Prevention for Health Care and Social Service Workers Act H.R. 1284/S. 403, Fair and Open Competition (FOCA) Act H.R. 1277/S. 374, Improving Corporate Governance Through Diversity Act of 2021 H.R. 1319, American Rescue Plan Act of 2021 H.R. 1458/S.490, Unemployment Insurance Technology Modernization Act of 2021 H.R. 1735/S. 673, Journalism Competition and Preservation Act of 2021 H.R. 2491, Wage Equity Act of 2021 H.R. 2668, Consumer Protection and Recovery Act H.R. 2795, DHS Blue Campaign Enhancement Act H.R. 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R. 2883, Stop Stalling Access to Affordable Medications H.R. 2884, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2891/S. 1428, Preserve Access to Affordable Generics and Biosimilars Act H.R. 2926/S. 663, One Agency Act H.R. 3110/S. 1658, Providing Urgent Maternal Protections (PUMP) for Nursing Mothers Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 H.R. 3460/S. 1787, State Antitrust Enforcement Venue Act of 2021 H.R. 3816/S. 2992, American Choice and Innovation Online Act H.R. 3825, Ending Platform Monopolies Act H.R. 3826/S. 3197, Platform Competition and Opportunity Act of 2021 H.R. 3843/S. 228, Merger Filing Fee Modernization Act of 2021 H.R. 3849, Augmenting Compatibility and Competition by Enabling Service Switching (ACCESS) Act of 2021 H.R. 4109/S. 2193, Protections for Socially Good Activities Act H.R. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4841, Restoring Justice for Workers Act H.R. 5017/S. 2710, Open App Markets Act H.R. 5376, Build Back Better Act H.R. 6922/S. 3760, Continued Waiver of Interest on State Unemployment Loans during the Pandemic Act H.R. 7194/S. 3889, Employee Rights Act H.R. 7309, Workforce Innovation and Opportunity Act of 2022 H.R. 7701, Wage Theft Prevention and Wage Recovery Act H.Res. 823, Providing for the consideration of the bill (H.R. 3460) to amend title 28 of the United States Code to prevent the transfer of actions arising under the antitrust laws in which a State is a complainant S. 225, Competition and Antitrust Law Enforcement Reform Act of 2021 S. 478, Higher Wages for American Workers Act of 2021 S. 977, No Oil Producing and Exporting Cartels (NOPEC) Act of 2021 S. 1074, Trust-Busting for the Twenty-First Century Act S. 1204, Bust Up Big Tech Act S. 1380, Clean Slate Act of 2021 S. 1425, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1636, Save Local Business Act S. 2039, Tougher Enforcement Against Monopolists (TEAM) Act S. 3311, FTC Integrity Act S. 3847, Prohibiting Anticompetitive Mergers Act of 2022 S. 3889, Employee Rights Act S. 4145, Consumer Protection Remedies Act of 2022 S. J. Res. 13, A joint resolution providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Equal Employment Opportunity Commission relating to "Update of Commission's Conciliation Procedures" Draft legislation titled Retirement Savings Modernization Act Draft legislation titled Making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2023, and for other purposes Nomination of Alvaro Bedoya to be a Member of the Federal Trade Commission Proposed rule on Joint Employer Status Under the Fair Labor Standards Act, (84 Fed. Reg. 14,043-14,061, April 9, 2019) Proposed rule on Independent Contractor status under the Fair Labor Standards Act (85 Fed. Reg. 60,600-60,639, September 25, 2020) Interim final rule on Occupational Exposure to COVID-19; Emergency Temporary Standard (86 Fed. Reg. 32,376-32,628, June 21, 2021) Interim final rule on COVID-19 Vaccination and Testing; Emergency Temporary Standard (86 Fed. Reg. 61,402-61,555, November 5, 2021) Advance Notice of Proposed Rulemaking Concerning Heat Injury and Illness Prevention in Outdoor and Indoor Settings (86 Fed. Reg. 59,309-59,326, Oct. 27, 2021) Proposed Amendments to Agriculture Acquisition Regulations (87 Fed. Reg. 9,005-9,021, February 17, 2022) Prohibited Transaction Exemption 2020-02, Improving Investment Advice for Workers & Retirees (85 Fed. Reg. 82,798-82,866, December 18, 2020) Final rule on Financial Factors in Selecting Plan Investments (85 Fed. Reg. 72,846-72,885, November 13, 2020) Final rule on Fiduciary Duties Regarding Proxy Voting and Shareholder Rights (85 Fed. Reg. 81,658-81,695, December 16, 2020) Proposed rule on Prudence and Loyalty in Selecting Plan Investments and Exercising Shareholder Rights (86 Fed. Reg. 57,272-57,304, October 13, 2021) Proposed rule, Improve Tracking of Workplace Injuries and Illnesses (87 Fed. Reg. 18,528-18,558, March 30, 2022) Request for Information, U.S. Department of Agriculture; Access to Fertilizer: Competition and Supply Chain Concerns (87 Fed. Reg. 15,191-15,194, March 17 2022) Notice of Limited Reopening of Comment Period, Occupational Safety and Health Administration; Occupational Exposure to COVID-19 in Healthcare Settings (87 Fed. Reg. 16,426-16,431, March 23, 2022) Proposed Rule, Occupational Safety and Health Administration; Powered Industrial Trucks Design Standard Update (87 Fed. Reg. 8,755-8,764, February 16, 2022) Various issues relating to modernization of the unemployment insurance system; application of Kristof Terryn to serve on the Department of Labor's Advisory Committee on Apprenticeship; paid leave; paid family leave; paid sick leave; reforms to the Fair Labor Standards Act (P.L. 75-178); independent contractors; unemployment insurance and the coronavirus pandemic; contractor blacklisting; Equal Employment Opportunity Commission (EEOC) conciliation regulation; the firing of Peter Robb as General Counsel of the National Labor Relations Board (NLRB), and of Alice Stock, Deputy General Counsel of the NLRB; Rescission of the Joint Employer standard under the Fair Labor Standards Act (P.L. 75-718); The FTC's Multilateral Pharmaceutical Merger Taskforce; The USMCA Labor Council; apprenticeships; proposed amendment to the U.S. Longshore and Harbor Workers Compensation Act (Longshore Act), relating to the establishment of statutory presumptions of coverage and compensability for illnesses; potential Wage and Hour Division rulemaking defining and delimiting the exemptions under the Fair Labor Standards Act for Executive, Administrative, Professional, Outside Sales and Computer Employees; potential Wage and Hour Division rulemaking on classification of independent contractors and employees; potential legislation on the minimum wage; COVID-19 vaccine requirements, including a potential Emergency Temporary Standard from the Occupational Safety and Health Administration relating to employers with more than 100 employees; vaccine requirements for federal contractors; legal and regulatory framework for evaluating mergers and acquisitions; contract terms and their relationship to competition, particularly relating to worker non-compete clauses and exclusive contracts; Federal Trade Commission issues: Freedom of Information Act Requests, Penalty Offense Authority, Zombie Voting, and overall direction of the Commission; anticipated overtime regulations under the Fair Labor Standards Act Office of Federal Contract Compliance Programs, Directive (DIR) 2022-01; Subject: Pay Equity Audits, Effective March 15, 2022; Executive Order 13999 Protecting Worker Health and Safety; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; Executive Order 14063, Promoting Competition in the American Economy; President Bidens Path Out of the Pandemic: COVID Action Plan; paid sick and paid family leave under the Families First Coronavirus Response Act (FFCRA) (P.L. 116-127); unemployment insurance; international concerns in the areas of antitrust, standards and investment; domestic and international antitrust policy; Federal Trade Commission (FTC) section 19/13b authority; Policies and practices related to the FTC expanding its authority; Transparency at the FTC; FTCs Draft Strategic Plan for Fiscal Years 2022 to 2026; efforts to revise the 1995 Bank Merger Competitive Review Guidelines; efforts to modernize enforcement of the antitrust laws regarding mergers; competition in the agriculture marketplace; pregnancy discrimination; oversight addressing the National Labor Relations Board, including implementation and oversight of the National Labor Relations Act (P.L. 74-198); election procedures under the Railway Labor Act (P.L. 69-257); National Labor Relations Board (NLRB) decisions and regulatory agenda; definition of labor organization under the Labor Management Reporting and Disclosure Act (P.L. 86-257); GAO study on Fiduciary Investment Advice

Client expense: $15,800,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC)

S.3799, "Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act" or the "PREVENT Pandemics Act"; Presidents FY23 Budget Request; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; H.R. 7035, the Biologics Market Transparency Act"; H.R. 7047, a bill to amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes; H.R. 1730, the Speeding Therapy Access Today Act of 2021; H.R. 2565, the FDA Modernization Act of 2021 ; H.R. 3085, the Equity in Neuroscience and Alzheimers Clinical Trials Act of 2021 or the ENACT Act of 2021; H.R. 3927, the Manufacturing API, Drugs, and Excipients in America Act or the MADE in America Act; H.R. 6963, the Accelerated Approval Integrity Act of 2022; H.R. 6973, the Enhanced Access to Affordable Medicines Act; H.R. 7006, the Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act; H.R. 7032, the Increasing Transparency in Generic Drug Applications Act; proposals related to the COVID-19 crisis including proposals to abrogate pharmaceutical patents used in the COVID-19 pandemic. Build Back Better Act provisions relating to drug pricing and HR 3, the "Elijah E. Cummings Lower Drug Costs Now Act," HR 19, the "Lower Costs, More Cures Act of 2021," HHS drug pricing plan to lower drug costs issued in connection with Executive Order 14,036 (Promote Competition in the American Economy), HR 2853, the "Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act of 2021" (or the "BLOCKING Act"), and HR 2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 (product hopping). Proposals to change pharmaceutical patent laws including HR 2891, "Preserve Access to Affordable Generics & Biosimilars Act" (patent settlements), and HR 2884, the "Affordable Prescriptions for Patients Through Improvement to Patent Litigation Act" (BPCIA litigation limits). Proposals to improve pharmaceutical supply-chain vulnerabilities. Proposals to retain and attract greater domestic manufacturing of pharmaceuticals including H.R. 2870, The Essential Medicines Strategic Stockpile Act of 2021. Proposals to change Medicare and Medicaid benefit design. Proposals to improve the drug approval process for generic medicines including HR 2883, "Stop Stalling Access to Affordable Medications Act" (citizens petitions), HR 2831, the "Prompt Approval of Safe Generic Drugs Act," HR 2843, "Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2021" (or the "STOP GAMES Act"), and S. 1462, the Simplifying the Generic Drug Application Process Act. S.164, Advancing Education on Biosimilars Act of 2021. S.415, a bill to amend the Federal Food, Drug & Cosmetic Act with respect to the scope of new chemical exclusivity. Implementation of the Food & Drug Reauthorization Act (PL 115-52). HR 153, the "Protecting Consumer Access to Generic Drugs Act of 2021." HR 2815, the "Bolstering Innovative Options to Save Immediately on Medicines Act" (or the "BIOSIM Act"). HR 2846, to amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purpose. S.1463, the Modernizing Therapeutic Equivalence Rating Determination Act.

Client expense: $550,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Reauthorization of PAHPA ---Tropical Disease Priority Review (PRV) Program ---White House National Biodefense Strategy Biosimilars ---H.R.7035: Biologics Market Transparency Act ---H.R.7047: A bill to Amend title III of PHSA re: determination re: biosimilar application elements ---Biosimilar Copay ---BSUFA Negotiations ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Coronavirus (COVID-19) Pandemic ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---COVID-19 Lessons Learned ---COVID-19 Pricing-Related Provisions ---COVID-19 Vaccine Distribution ---Defense Production Act (DPA) ---Drug Supply Chain Management ---Healthcare Disparities ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of Families First Coronavirus Response Act of 2020 ---Medicare Reimbursement Policies ---Monoclonal Antibody Coverage and Utilization ---Patient Cost-Sharing and Smoothing ---PREP Act COVID-19 Declaration Coverage for Private Sector Procurement ---R&D Funding for Medical Countermeasures ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Small Business Loans ---Supply Chain Issues ---TRIPS IP Waiver Climate Change ---FY 2023 Appropriations Data Privacy ---H.R.8152: American Data Privacy and Protection Act Diagnostics and Personalized Medicine Regulation and Oversight ---H.R.4128/S.2209: VALID Act Diversity & Inclusion ---H.R.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---H.R.5030: Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act ---H.R.6584: Diverse and Equitable Participation in Clinical Trials (DEPICT) Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.4472: Better Empowerment Now To Enhance Framework and Improve Treatments (BENEFIT) Act ---H.R.4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R.6963: Accelerated Approval Integrity Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---H.R.6996: Accelerating Approval for Patients Act ---H.R.7008: The Pre-Approval Information Exchange Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1644 Promising Pathway Act ---S.1645: Accelerated Drug Approval for Prescription Therapies ADAPT Act ---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---S.4351: Enhanced Access to Affordable Medicines Act of 2022 ---COVID-19 Lessons Learned ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VII Priorities ---Priority Review Voucher Programs ---Reforms to the Accelerated Approval Pathway ---Regulatory Reform & Modernization ---Use of Real-World Evidence Drug Importation ---S.920: A bill to amend the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors, pharmacies, and individuals ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Drug Manufacturing, Quality & Distribution ---H.R.1959: Preserving Patient Access to Compounded Medications Act of 2019 ---H.R.3927/S.2082: Manufacturing API, Drugs, and Excipients (MADE) in America Act ---H.R.6988: Drug Manufacturing Innovation Act ---H.R.7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies (INSPECTIONS) Act ---H.R.7767: A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Counterfeiting ---Drug Shortages ---Executive Order on Buy American ---Pharmacy Compounding & Oversight ---Supply Chain Integrity and Traceability Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Drug Pricing ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.4418: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.7667: The Food and Drug Amendments of 2022 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Implementation of Consolidated Appropriations Act for FY 2021 ---National Coverage Determination Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.4521: America COMPETES Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---S.1260: United States Innovation and Competition Act of 2021 ---Build Back Better Act (Discussion Draft Senate) ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Reauthorization of PAHPA Funding for FDA ---FY 2023 Appropriations ---FY 2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies funding bill ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Prescription Drug User Fee Act (PDUFA) VII Priorities Funding for Health Resources and Services Administration (HRSA) ---FY 2023 Appropriations ---Implementation of Consolidated Appropriations Act for FY 2021 Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.623: Gabriella Miller Kids First Research Act 2.0 ---H.R.5585: Advanced Research Projects Agency for Health (ARPA-H) Act Funding for the Centers for Disease Control and Prevention Vaccine Programs ---FY 2023 Appropriations ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of Consolidated Appropriations Act for FY 2021 ---Implementation of Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations Generic Drug Entry ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 ---H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act ---H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act ---H.R.7667: The Food and Drug Amendments of 2022 ---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---S.4293: Pharmacy Benefit Manager Transparency Act of 2022 ---Alternative Payment Arrangements for Gene Therapies ---Coverage of Accelerated Approval Products ---Drug Benefit Design ---Implementation of Consolidated Appropriations Act for FY 2021 ---Pricing and Rebates Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 Orphan Drug Issues ---H.R.1629: Fairness in Orphan Drug Exclusivity Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.5566 Finding Orphan-Disease Remedies With Antifungal Research and Development (FORWARD) Act ---S.4184 Retaining Access and Restoring Exclusivity (RARE) Act ---Build Back Better Act (Discussion Draft Senate) ---Orphan Drug Tax Credit Precision Medicine Initiative Rare Pediatric Disease Priority Review ---H.R.1730: Speeding Therapy Access Today (STAT) Act ---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R.6972/S.4215: Give Kids a Chance Act of 2022 ---Implementation of Consolidated Appropriations Act for FY 2021 ---Rare Disease Pilot Program Reimbursement and Coverage of Innovative Products ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.19/S.2164: Lower Costs, More Cures Act of 2021 ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2148/S.909: Prescription Drug Price Relief Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---S.2416: New Opportunities for Value that Extend Lives (NOVEL) Act of 2021 ---Administration Rebate Rule ---Build Back Better Act (Discussion Draft Senate) ---CMMI Authority ---Implementation of Consolidated Appropriations Act for FY 2021 ---Medicare Part B Physician-Administered Products ---National Coverage Determination ---Patient Cost-Sharing and Smoothing ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R.951/H.R.959/S.345/S.346: Maternal Vaccinations Act of 2021 ---H.R.1978/S.912: Protecting Seniors through Immunizations Act of 2021 ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.2347/S.2691: Strengthening the Vaccines for Children Program Act of 2021 ---H.R.3655: Vaccine Injury Compensation Modernization Act of 2021 ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---Adult Immunization ---Implementation of Consolidated Appropriations Act for FY 2021 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---National Coverage Determination ---Recovery of Routine Immunizations ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R.3656: Vaccine Access Improvement Act of 2021

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), SENATE, White House Office

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 ---Proposed FTC/DOJ Merger Guidelines Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights ---NIST Proposed Rulemaking on Bayh-Dole Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver ---Coronavirus Supplemental Appropriations Data Privacy Issues ---S.2499: Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act ---US-EU Privacy Shield Drug Patenting ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.5902: CLEAR Patents Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---H.R.5874: Restoring America's Leadership in Innovation Act ---H.R.5902: CLEAR Patents Act of 2021 ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---S.4417: Patent Trial and Appeal Board Reform Act of 2022 ---S.4430: Interagency Patent Coordination and Improvement Act of 2022 ---Patent Litigation Reform

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office

Antitrust Consumer welfare standard S. 225 (Competition and Antitrust Law Enforcement Reform Act) H.R. 3460/S. 1787 (State Antitrust Enforcement Venue Act) H.R. 3816/S. 2992 (American Choice and Innovation Online Act) H.R. 3825 (Ending Platform Monopolies Act) H.R. 3826/S. 3197 (Platform Competition and Opportunity Act) H.R. 3843/S. 2039 (Merger Filing Fee Modernization Act) S. 228 (TEAM Act) H.R. 3849 (ACCESS Act) H.R. 5639 (Foreign Merger Subsidy Disclosure Act) House Judiciary Comm. Final Report on Investigation of Competition in Digital Markets S. 1435/H.R. 2873 (Affordable Prescriptions for Patients Through Promoting Competition Act) S. 1425/H.R. 2883 (Stop STALLING Act) S. 1428/H.R. 2891 (Preserve Access to Affordable Generics) S. 4258/H.R. 7839 (Competition and Transparency in Digital Advertising Act) Federal Trade Commission motion to rescind the 2015 Statement of Enforcement Principles Regarding Unfair Methods of Competition (UMC) Under Section 5 of the FTC Act Multilateral Pharmaceutical Merger Task Force (FTC Pharmaceutical Task Force, Project No. P212900) Executive Order 14036 (Promoting Competition in the American Economy) FTC Rescission of 1995 Policy Statement on Prior Approval and Prior Notice Provisions in Merger Cases FTCs counting votes cast by a former commissioner Nominations to Federal Trade Commission positions FTC-Justice Dept. Request for Information on proposed Merger Enforcement Guidelines (FTC-2022-0003)

Client expense: Not reported · Firm income: $60,000

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE

H.R. 349: Coronavirus Vaccine and Therapeutic Development Act of 2021 - Provisions related to manufacturing of COVID-19 treatments and vaccines H.R. 550: Immunization Infrastructure Modernization Act (IIS harmonization) H.R. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines H.R. 1730: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research H.R. 2815: BIOSIM Act - Provisions related to biosimilars and prescription drug pricing H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions H.R. 3656/S. 3087: Vaccine Access Improvement Act (VICP program changes) H.R. 3761: Promising Pathways Act - Provisions related to FDA policy H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues H.R. 4127: DISARM Act Provisions related to antimicrobial drug development H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program H.R. 4472: BENEFIT Act of 2021 - Provisions related to FDA policy H.R. 4511: FDA Advancing Collection of Transformative Science Act or the FACTS Act  H.R. 5030: DIVERSE Trials Act - Provisions related to clinical trial diversity H.R. 5416: Give Kids a Chance Act H.R. 5585: Advanced Research Project Agency-Health Act - Provisions related to health research H.R. 5801: HELP Copays Act - Provisions related to prescription drug pricing and cost-sharing H.R. 6000: Cures 2.0 Act - Provisions related to health research H.R. 6228: Capping Prescription Costs Act of 2021 - Provisions related to prescription drug pricing and cost-sharing H.R. 6584: DEPICT Act - To direct the Commissioner of Food and Drugs to amend certain regulations to increase clinical trial diversity, and for other purposes H.R. 6888: Helping Experts Accelerate Rare Treatments Act of 2022 H.R. 6963: Accelerated Approval Integrity Act of 2022 - Provisions related to accelerated approval H.R. 6972: Give Kids a Chance Act of 2022 - Provisions related to additional authorities and pediatric investigations H.R. 6973: Enhanced Access to Affordable Medicines Act of 2022 - Provisions related to labeling H.R. 6988: Drug Manufacturing Innovation Act of 2022  H.R. 6996: Accelerating Access for Patients Act of 2022 H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and Overseeing Needed Supplies Act or the INSPECTIONS Act  H.R. 7008: Pre-Approval Information Exchange Act of 2022   H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 H.R. 7035: Biologics Market Transparency Act of 2022 H.R. 7047: Lowering Costs by Improving Biosimilar Uptake Act S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions S. 670: Speeding Therapy Access Today Act of 2021 - Provisions related to FDA policy and health research S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program S. 912/H.R. 1978: Protecting Seniors Through Immunization Act S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation S. 1425: Stop STALLING Act - Provisions related to citizen petitions S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals S. 1463: Modernizing Therapeutic Equivalence Rating Determination Act S. 1644: Promising Pathway Act - Provisions related to FDA policy S. 1645: ADAPT Act - Provisions related to FDA policy S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act S. 2706: DIVERSE Trials Act - Provisions related to FDA policy S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program S. 2983: ADAPT for COVID Act - Provisions related to FDA accelerated approval pathways S. 3291: STAAR Act - Provisions related to health research and antibiotic resistance S. 3449: Registration of Certain Foreign Establishments Act S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act Cancer Moonshot Initiative 21st Century Cures 2.0 RFI for Advanced Research Projects Agency - Health (ARPA-H) Department of Homeland Security cybersecurity policy issues Drug cost and pricing policy issues Principles for drug pricing reform Drug importation policy issues Drug counterfeiting policy issues PDUFA reauthorization BsUFA reauthorization Competition policy issues Orphan Drug Act (ODA) policy issues Health Advanced Research Projects Agency (HARPA) proposal Expanded access policy issues Antimicrobial resistance (AMR) policy issues High deductible health plans/HSA policy issues Supply chain and foreign manufacturing policy issues Real world evidence policy issues Clinical trial diversity policy issues FDA modernization policy issues 340B drug discount program policy issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug shortages policy issues Regulatory efficiencies policy issues COVID-19 policy issues/Emergency supplemental funding Pandemic preparedness policy issues Defense Production Act (DPA) policy issues Final Rule; Importation of Prescription Drugs Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Nomination of Robert Califf to FDA Commissioner HSA/FSA for Dietary Supplements Dietary Supplement Health and Education Act Reform

Client expense: $1,100,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

Issues related to prescription drug coverage and pharmacy benefits Regulatory and proposed legislative changes to Medicare Part D and Medicaid prescription drug benefits Access to prescription drugs during the coronavirus pandemic S.298 / H.R.1829: Pharmacy Benefit Manager Accountability Study Act of 2021 S.464 / H.R.2163: Safe Step Act S.917: Short on Competition Act H.R.2355: Opioid Prescription Verification Act H.R.2410: Medicare and You Handbook Improvement Act H.R.2484: Lowest Price for Patients Act H.R.2608: Ensuring Seniors Access to Local Pharmacies Act H.R.3: Elijah E. Cummings Lower Drug Costs Now Act H.R.19: Lower Costs, More Cures Act H.R.2843: STOP GAMES Act H.R.2846: Ensuring Access to Lower-Cost Medicines for Seniors Act H.R.2853: BLOCKING Act H.R.2855: Star Ratings for Biosimilars Act S.1388: Prescription Pricing for the People Act S.1425 / H.R.2883: Stop STALLING Act S.1427 / H.R.2869: Increasing Access to Biosimilars Act S.1428 / H.R.2891: Preserve Access to Affordable Generics and Biosimilars Act S.1435 / H.R.2873: Affordable Prescriptions for Patients Act of 2021 / Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act S.1462: Simplifying the Generic Drug Application Process Act S.1463: Modernizing Therapeutic Equivalence Rating Determination Act S.1523: The Drug Price Transparency Act S.1524 / H.R.3029: Health Care PRICE Transparency Act H.R.3173: Improving Seniors Timely Access to Care Act S.1909 / H.R.3554: Pharmacy DIR Reform to Reduce Senior Drug Costs Act H.R.3682: Improving Transparency to Lower Drug Costs Act S.2164: Lower Costs More Cures Act H.R.4121: To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates, and for other purposes H.R.4158: To amend titles XVIII and XIX of the Social Security Act to eliminate cost sharing with respect to coverage of insulin as a covered part D drug under the Medicare program or as a covered outpatient drug under the Medicaid program H.R.4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022 H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R.4813: Matts Act S.2814: Vital Medication Affordability Act S.1132: Ending Pricey Insulin (EPI) Act H.R.3062: A bill making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for fiscal year ending September 30, 2022 H.R.6000: The CURES 2.0 Act, To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes H.R.3554: To amend title XVIII of the Social Security Act to reform requirements with respect to direct and indirect remuneration under Medicare part D, and for other purposes H.R.6851: To amend the Families First Coronavirus Response Act and the CARES Act to establish new coverage and payment rules for certain COVID-19 diagnostic tests and related items and services, and for other purposes S.3700: A bill to provide for appropriate cost-sharing for insulin products covered under Medicare part D and private health plans H.R.6833: To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to establish requirements with respect to cost-sharing for certain insulin products, and for other purposes H.R.6757: To amend title XVIII of the Social Security Act to establish under the Medicare prescription drug program a minimum amount of price concessions for insulin to be passed through to beneficiaries at the point-of-sale, and for other purposes H.R.7008: To improve patient access to emerging medication therapies by clarifying the scope of permitted health care economic and scientific information communications between biopharmaceutical manufacturers and population health decision makers, and for other purposes H.R.7047: To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes 42 CFR Part 1001 RIN 0936-AA08: Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees 42 CFR Parts 422 423 RIN 0938-AU30 Medicare Program; Contract Year 2003 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs Proposed Rule (CMS-4192-P)

Client expense: $2,715,700 · Firm income: Not reported

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

Reform of Section 101 of the patent code. IP proposals related to drug pricing legislation including regulatory data protection for biologics, march in rights provisions of the Bayh-Dole Act, and Section 1498 of the patent code. S.1435/H.R. 2873/H.R. 2884 (patent thickening/product hopping) S.1425/H.R. 2883 (citizen petitions) S.1428/H.R.2891 (Rx patent settlements) Leahy-Cornyn Restoring the America Invents Act, PTAB reform bill.

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), Patent & Trademark Office (PTO), SENATE

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)

Client expense: $1,480,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Science & Technology Policy (OSTP), SENATE, White House Office

Antitrust Legislation ---S.225: Competition and Antitrust Law Enforcement Reform Act of 2021 Bayh-Dole Act/Tech Transfer ---Bayh-Dole Act ---March-In Rights Coronavirus (COVID-19) Pandemic ---Restrictions on Intellectual Property Rights ---TRIPS Waiver ---Coronavirus Supplemental Appropriations Data Privacy Issues ---US-EU Privacy Shield Diversity in Patenting ---H.R.1723/S.632: Inventor Diversity for Economic Advancement (IDEA) Act of 2021 Drug Patenting ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R.2873/S.1435: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 ---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications ---H.R.2884/S.1435: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2021 ---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---Restrictions on Intellectual Property Rights Intellectual Property Enforcement ---TRIPS Waiver Inter Partes Review ---S.2774: Pride in Patent Ownership Act ---S.2891: Restoring the America Invents Act ---Support Technology and Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act (Discussion Draft) ---Implementation of America Invents Act of 2011 Patent Reform ---S.1260: United States Innovation and Competition Act of 2021 ------Ownership and Assignments of Patents ---Patent Litigation Reform Patenting of Biological Inventions ---35 USC Section 101 on Patent Eligibility ---Section 101 Modernization

Client expense: $3,170,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR), White House Office