Preserve Access to Affordable Generics and Biosimilars Act

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $860,000 · Firm income: Not reported

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

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 1976, Medicare for All Act of 2021 H.R. 2471, Consolidated Appropriations Act, 2022 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. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 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. 5981/S.1704, Telehealth Expansion Act of 2021 H.R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 H.R. 8594/S. 4750, Restore Protections for Dialysis Patients Act S. 150, Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act S. 380, Health Savings Act of 2021 S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 Implementation of the Transparency in Coverage Final Rule; Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services (85 Fed. Reg. 72,158 - 72,310, November 12, 2020) Requirements Related to Surprise Billing; Internal Revenue Service; Employee Benefits Security Administration; Department of Health and Human Services (87 Fed. Reg. 52,618-52,655, August 26, 2022) Request for Information, Centers for Medicare & Medicaid Services; Medicare Program (87 Fed. Reg. 46,918-46,921, August 1, 2022) Notice of Proposed Rule, Employee Benefits Security Administration; Proposed Amendment to Prohibited Transaction Class Exemption 84-14 (the QPAM Exemption (87 Fed. Reg. 45,204-45,232, July 27, 2022) Affordability of Employer Coverage for Family Members of Employees (Family Glitch Regulation) (87 Fed. Reg. 20,354-20,364, April 7, 2022) Various issues relating to the employer-sponsored health care system, the "family glitch", implementation of regulatory process, provider network adequacy, health savings account (HSAs), health reimbursement account (HRAs), employer mandate; coronavirus pandemic; vaccine distribution, PPE, testing, medications and treatments, and vaccination incentives; digital health credentials; vaccine diplomacy; 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; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; implementation of the American Rescue Plan Act (P.L. 117-2); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; comments on COVID-19 Telehealth Program Application Evaluation Metrics (WC Docket No. 20-89); efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health systems strengthening; greater harmonization of standards and investment in digital health internationally; role of private sector related pandemic prevention, preparedness and response

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade & Development Agency (USTDA), U.S. Trade Representative (USTR)

H.R. 4521, United States Innovation and Competition Act of 2021 H.R. 5376, Inflation Reduction Act of 2022 H.R. 5429, Save our Stages Extension Act H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act H.R. 7430, Protecting American Innovation Act H.R. 7582/S. 4063, No Free TRIPS Act H.R. 7776, James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation revising the Family Entertainment and Copyright Act of 2005 Potential legislation making omnibus year-end appropriations Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Notice, Patent Subject Matter Eligibility Guidance, U.S. Patent and Trademark Office (87 Fed. Reg. 53,736-53,737, September 1, 2022) Request for Comment, Office of the United States Trade Representative; 2022 Review of Notorious Markets for Counterfeiting and Piracy (87 Fed. Reg. 52,609-52,611, August 26, 2022) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments; third party litigation funding and patent litigation

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

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

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $6,610,000 · Firm income: Not reported

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

H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $1,390,000 · 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 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

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)

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs H.R. 4521, United States Innovation and Competition Act of 2021 H.R. 5376, Inflation Reduction Act of 2022 H.R. 5429, Save our Stages Extension Act H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act H.R. 7430, Protecting American Innovation Act H.R. 7582/S. 4063, No Free TRIPS Act S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation revising the Family Entertainment and Copyright Act of 2005 Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 1976, Medicare for All Act of 2021 H.R. 2471, Consolidated Appropriations Act, 2022 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. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 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. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 S. 150, Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act S. 380, Health Savings Act of 2021 S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 Nomination of Robert Gordon to be Assistant Secretary for Financial Resources at the Department of Health and Human Services Implementation of the Transparency in Coverage Final Rule; Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services (85 Fed. Reg. 72,158 - 72,310, November 12, 2020) Requirements Related to Surprise Billing; Internal Revenue Service; Employee Benefits Security Administration; Department of Health and Human Services (87 Fed. Reg. 52,618-52,655, August 26, 2022) Request for Information, Centers for Medicare & Medicaid Services; Medicare Program (87 Fed. Reg. 46,918-46,921, August 1, 2022) Affordability of Employer Coverage for Family Members of Employees (Family Glitch Regulation) (87 Fed. Reg. 20,354-20,364, April 7, 2022) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business; coronavirus pandemic; vaccine distribution, PPE, testing, medications and treatments, and vaccination incentives; digital health credentials; vaccine diplomacy; 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; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; implementation of the American Rescue Plan Act (P.L. 117-2); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; petition to the Department of Labor Requesting a 60-Day Extension to Comment on Proposed Amendment(s) to Prohibited Transaction Class Exemption 84-14; comments on COVID-19 Telehealth Program Application Evaluation Metrics (WC Docket No. 20-89); efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health system strengthening; greater harmonization of standards and investment in digital health internationally; role of private sector related pandemic prevention, preparedness and response

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS)

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 S. 4704: Patent Examination and Quality Improvement Act of 2022 S. 4918: Increasing Prescription Drug Competition Act - Patent-related policy issues Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $7,270,000 · Firm income: Not reported

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

Protection of inter partes review process to invalidate improperly granted patents. S. 2891 - Restoring the America Invents Act S. 4417 - PTAB Reform Act Preservation of patent settlement rights (including advocacy related to S. 1428).

Client expense: Not reported · Firm income: $30,000

Government targets: Federal Trade Commission (FTC), SENATE

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

Issues related to Inter Partes Review and patent policy generally; Preserving Access to Affordable Generics and Biosimilars Act, S. 1428, H.R. 2891; Affordable Prescriptions for Patients Act, S.1435, H.R. 2873; Restoring the America Invents Act, S. 2891.

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

Government targets: HOUSE OF REPRESENTATIVES, 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

Issues related to Inter Partes Review and patent policy generally; Preserving Access to Affordable Generics and Biosimilars Act, S. 1428, H.R. 2891; Affordable Prescriptions for Patients Act, S.1435, H.R. 2873; Restoring the America Invents Act, S. 2891.

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

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

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matter relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $1,110,000 · Firm income: Not reported

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

H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 1857: Protecting Access to Safe and Effective Medicines Act of 2021 - Provisions related to FDA policy and exclusivity H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 5635: Intellectual Property Violators Accountability and Transparency Act - Provisions related to intellectual property protections H.R. 5874: Restoring Americas Leadership in Innovation Act of 2021 - Provisions related to intellectual property protections S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity (Public Law 117-9) - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2773: Unleashing American Innovators Act of 2021 - Provisions related to USPTO policy S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 2910: Expanding Access to Low-Cost Generics Act of 2021 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes S. 4417: Patent Trial and Appeal Board Reform Act of 2022 - To amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes S. 4430: Interagency Patent Coordination and Improvement Act of 2022 Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $6,340,000 · 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

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. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act H.R. 7430, Protecting American Innovation Act H.R. 7582/S. 4063, No Free TRIPS Act S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Potential legislation revising the Family Entertainment and Copyright Act of 2005 Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Nomination of Katherine Vidal to be Director of the U.S. Patent and Trademark Office (USPTO) Request for Information, Department of Agriculture; Regarding Competition and the Intellectual Property System: Seeds and Other Agricultural Inputs (87 Fed. Reg. 29,730, March 17, 2022) Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

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)

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 1976, Medicare for All Act of 2021 H.R. 2471, Consolidated Appropriations Act, 2022 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. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 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 S. 150, Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act S. 380, Health Savings Act of 2021 S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 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 Robert Gordon to be Assistant Secretary for Financial Resources at the Department of Health and Human Services Implementation of the Transparency in Coverage Final Rule; Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services (85 Fed. Reg. 72,158 - 72,310, November 12, 2020) Interim final rule, Most Favored Nation (MFN) Model (85 Fed. Reg. 76,180-76,259, November 27, 2020) Proposed rule regarding Affordability of Employer Coverage for Family Members of Employees (87 Fed. Reg. 20,354-20,364, April 7, 2022) Withdrawal of a Notice of Proposed Rulemaking, Internal Revenue Service; Affordability of Employer Coverage for Family Members of Employees (87 Fed. Reg. 20,354-20,364, April 7, 2022) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business; coronavirus pandemic; vaccine distribution, PPE, testing, medications and treatments, and vaccination incentives; digital health credentials; vaccine diplomacy; 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; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; implementation of the American Rescue Plan Act (P.L. 117-2); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; impact of Pharmacy Benefit Managers Practices; FTC-2022-0015; petition to HHS to grant march-in rights for the patents on the drug Xtandi; efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health system strengthening

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, State, Dept of (DOS)

Protection of inter partes review process to invalidate improperly granted patents. S. 2891 - Restoring the America Invents Act S. 4417 - PTAB Reform Act Preservation of patent settlement rights (including advocacy related to S. 1428).

Client expense: Not reported · Firm income: $30,000

Government targets: 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. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

Client expense: $1,100,000 · 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 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

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

21st Century Cures Act 2.0 ---H.R.6000: Cures 2.0 Act 340B Drug Discount Program ---H.R.5376: Build Back Better Act of 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Non-Funding) ---S.3799: PREVENT Pandemics Act ---American Pandemic Preparedness Plan (AP3) ---Executive Order on Modernizing Influenza Vaccines ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---White House National Biodefense Strategy ---Tropical Disease Priority Review (PRV) Program Biosimilars ---H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021 ---H.R. 7035: Biologics Market Transparency Act ---H.R.2815: BIO SIM Act ---H.R.5376: Build Back Better Act of 2021 ---Biosimilar Copay ---BSUFA Negotiations ---BSUFA III Discussion Draft ---Interchangeability and Pharmacy Substitution ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 Coronavirus (COVID-19) Pandemic ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act ---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.2327: Seniors Prescription Drug Relief Act ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---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 the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---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 ---Temporarily Refundable R&D Credit ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper ---Supply Chain Issues ---TRIPS IP Waiver Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Draft Discussion) Diversity & Inclusion ---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.729: Strength in Diversity Act of 2021 ---H.R.3085: Equity in Neuroscience and Alzheimer's Clinical Trials (ENACT) Act of 2021 ---Clinical Trial Diversity Drug Evaluation and Review ---H.R. 4472: Better Empowerment Now To Enhance Framework and Improve Treatments Act ( BENEFIT Act) ---H.R. 4511: FDA Advancing Collection of Transformative Science (FACTS) Act ---H.R. 6963: Accelerated Approval Integrity Act ---H.R. 6996: Accelerating Approval for Patients Act ---H.R. 7008: The Pre-Approval Information Exchange Act ---S.1644 Promising Pathway Act ---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 ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---Use of Real-World Evidence ---FDA Hiring Flexibility ---FDA Management and Financial Accountability Drug Importation ---H.R.4811: Medicare Negotiation and Competitive Licensing Act ---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 Drug Manufacturing, Quality & Distribution ---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. ---H.R. 3927: Manufacturing API, Drugs, & Excipients in America (MADE in America) Act ---H.R. 7006: Improving the Nations Safe Pharmaceuticals and Excipients by Creating Tools for Inspecting and overseeing Needed Supplies Act (INSPECTIONS Act) ---Executive Order on Buy American ---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.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.4811: Medicare Negotiation and Competitive Licensing Act ---H.R.5376: Build Back Better Act of 2021 ---S.1388: Prescription Pricing for the People Act of 2021 ---S.1435: Affordable Prescriptions for Patients Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---CMMI Authority ---COVID-19 Pricing-Related Provisions ---Senate Finance Committee Drug Pricing Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance (AMR) Programs ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3932/S.2076: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) ---H.R.4127: DISARM Act ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.5376: Build Back Better Act of 2021 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for Strategic National Stockpile ---Health Defense Operations Funding Designation ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for FDA ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---Implementation of the 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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Funding for National Institutes of Health ---FY 2023 Appropriations ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---S.3799: PREVENT Pandemics Act ---Funding for 2022-2023 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act Generic Drug Entry ---H.R. 7032: Increasing Transparency in Generic Drug Applications Act ---H.R.2883: Stop Stalling Access to Affordable Medications Act ---H.R.2853: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2021 Medicaid ---H.R.3: Elijah E. Cummings Lower Drug Costs Now Act ---H.R.2139/S.908: Medicare Drug Price Negotiation Act ---H.R.2170/S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act ---H.R.5376: Build Back Better Act of 2021 ---H.R.6833/S.3700: Affordable Insulin Now Act ---Oregon 1115 Medicaid Waiver ---Alternative Payment Arrangements for Gene Therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Opioid Crisis ---FDA Reforms 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 ---H.R.133: Consolidated Appropriations Act of 2021 ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R. 6888: Helping Experts Accelerate Rare Treatments (HEART) Act ---H.R. 1730: Speeding Therapy Access Today (STAT) Act ---Orphan Drug Act Reforms ---Tax Credit 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.133: Consolidated Appropriations Act of 2021 ---H.R.2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5237/H.R.5260: Reduced Costs and Continued Cures Act ---H.R.5376: Build Back Better Act of 2021 ---S.2327: Seniors Prescription Drug Relief Act ---Coronavirus Supplemental Appropriations ---Administration Rebate Rule ---CMMI Authority ---Patient Cost-Sharing and Smoothing ---Value-Based Purchasing (VBP) Rule Vaccines and Infectious Diseases ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---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.5376: Build Back Better Act of 2021 ---S.4509: Vaccine and Coverage Certainty (VACC) Act ---S.581: Helping Adults Protect Immunity (HAPI) Act of 2021 ---S.3799: PREVENT Pandemics Act ---Coronavirus Supplemental Appropriations ---Adult Immunization ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Monoclonal Antibody Coverage and Utilization ---Vaccine and Antimicrobial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program Vaccine Injury Compensation Program ---FY 2023 Appropriations ---H.R. 2471: Consolidated Appropriations Act of 2022 ---H.R.6119: Further Extending Government Funding Act ---H.R.3656: Vaccine Access Improvement Act of 2021 ---S.3087: Vaccine Access Improvement Act of 2021

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

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

Monitor issues related to Inter Partes Review and patent reform generally; Preserving Access to Affordable Generics and Biosimilars Act, S. 1428, H.R. 2891; Affordable Prescriptions for Patients Act, S.1435, H.R. 2873; Restoring the America Invents Act, S. 2891.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patent Settlements. H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act. H.R.153: Protecting Consumer Access to Generic Drugs Act of 2021. Patent Abuse. H.R.2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act. Skinny Labeling. REMEDY Act. BPCIA Patent Dance. Patent Listings in Orange Book. Inter Partes Review. Impact of IPR decisions on 30-month stay. Section 101 of the Patent Act. Product Hopping. H.R.2873/S.1435: Affordable Prescriptions for Patients Act of 2021. TAB Appointments Clause (Arthrex Case). Enhancing Quality of Patents through the PTAB. H.R._/S.2891: Restoring the America Invents Act.

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

Government targets: Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

H.R. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements H.R. 728: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 187: Pandemic Emergency Manufacturing Act of 2021 - Provisions related to intellectual property and march-in rights S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency S. 2891: Restoring the America Invents Act - Provisions related to USPTO policy Biopharmaceutical innovation and patent policy issues Bayh-Dole march-in rights policy issues

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

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

H.R. 1319 - American Rescue Plan Act of 2021 - support passage H.R. 5376, Build Back Better Act, support passage S. 898- Fair Accountability and Innovative Research Drug Pricing Act of 2021 - support passage S. 368/H.R. 1332 - Telehealth Modernization Act - support passage S.464/H.R. 2163- Safe Step Act, support passage H.R. 366 - Protecting Access to Post-COVID-19 Telehealth Act of 2021 - support passage H.R. 4418 - SPIKE Act- "To amend title XI of the Social Security Act to provide for drug manufacturer price transparency."- support passage S.2210-."Better Care Better Jobs Act"- support passage S.2164- "Lower Costs, More Cures Act of 2021"- support passage S.1524/H.R. 3029- "Health Care PRICE Transparency Act"- support passage S.1428/H.R. 2891-"Preserve Access to Affordable Generics and Biosimilars Act"- support passage S.1427/H.R. 2869-"Increasing Access to Biosimilars Act of 2021"- support passage H.R.2846-"Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021"-support passage H.R.2843-"STOP GAMES Act of 2021"- support passage H.R.3-"Elijah E. Cummings Lower Drug Costs Now Act" - support passage H.R.2855-"Star Rating for Biosimilars Act"- support passage S.164-"Advancing Education on Biosimilars Act of 2021"- support passage H.R.19- "Lower Costs, More Cures Act of 2021"- support passage Wyden Releases Principles For Lowering Drug Prices for Americans, support passage H.R. 2503, Social Determinants Accelerator Act of 2021, support passage S.1524/H.R.3029- Health Care Price Transparency Act, support passage H.R. 2884- Affordable Prescriptions for Patients Through Improvement t o Patent Litigation Act, support passage H.R. 2873- Affordable Prescriptions for Patients Through Promoting Competition Act of 2021, support passage H.R. 5365, Primary Health Services Enhancement Act, support passage H.R. 2575, Social Security Disability Insurance Return to Work Act, monitor for position determination S.2565- Expanding Access to Palliative Care Act, monitor for impact on people affected by MS H.R. 4714- Disabled Access Credit Expansion Act of 2021- support passage S. 1435, Affordable Prescriptions for Patients Act of 2021, monitor for position determination H.R. 3971, Double Dip Elimination Act, monitor for position determination H.R. 3765, Disability Employment Incentive Act, support passage H.R. 5801, Help Copays Act, support passage

Client expense: $58,183 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act, including provisions related to price controls and prescription drugs H.R. 5502/S. 936, Integrity, Notification, and Fairness in Online Retail Marketplaces for (INFORM) Consumers Act S. 1260, United States Innovation and Competition Act of 2021, including provisions related to research funding and cybersecurity S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 S. 1843, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2021 Fiscal Year 2022 Financial Services and General Government Appropriations bill, including provisions related to funding for the Office of Intellectual Property Enforcement Coordinator and other federal agencies appropriations related to intellectual property enforcement Draft legislation titled Digital Copyright Act of 2021 (discussion draft) Potential legislation similar to H.R. 6058, Stopping Harmful Offers on Platforms by Screening Against Fakes in E-commerce (SHOP SAFE) Act of 2020 Potential legislation similar to S. 1416, Affordable Prescriptions for Patients Act of 2019 Nomination of Chris Wilson to be Chief Intellectual Property Negotiator for the Office of the U.S. Trade Representative Various issues relating to implementation of Trade Facilitation and Trade Enforcement Act of 2015 (P.L. 114-125); nomination vacancies relating to intellectual property, including for an Intellectual Property Enforcement Coordinator (IPEC); Office of the Intellectual Property Enforcement Coordinator and the National Intellectual Property Rights Coordination Center; the U.S. Patent and Trademark Office; World Trade Organization pending proposal related to COVID-19 and intellectual property rights; prospective nomination of Laurie Hill to be Director of U.S. Patent and Trademark Office; State Department Office of Authentication; IP issues related to Australia, Canada, China, India, Brazil, Europe, Mexico and South Africa; IP issues related to internet counterfeiting and piracy; patent linkage and regulatory data protection; the World Intellectual Property Organization; the World Trade Organization; the World Health Organization; the International Telecommunications Union; IP issues related to the U.S.-Mexico, Canada Agreement (USMCA); IP issues related to prescription drug pricing and labeling; modernization of the U.S. Copyright Office; increased utilization of federal criminal penalties resulting from the passage of the Protect Lawful Streaming Act (PSLA) (P.L. 116-260, Div. Q, Title II), for certain types of copyright infringement via illicit streaming of copyrighted works; intellectual property enforcement priorities at the U.S.-Mexico border; licensing negotiations and remedies for standard-essential patents subject to voluntary F/RAND commitments

Client expense: $18,660,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Copyright Office, U.S. Trade Representative (USTR), White House Office

H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act H.R. 1319, American Rescue Plan Act of 2021 H.R. 1976, Medicare for All Act of 2021 H.R. 2471, Consolidated Appropriations Act, 2022 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. 2891, Preserve Access to Affordable Generics and Biosimilars Act H.R. 3114, Longshore and Harbor Workers COVID-19 Compensation Act of 2021 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 S. 150, Ensuring Parity in Medicare Advantage for Audio-Only Telehealth Act S. 380, Health Savings Act of 2021 S. 1428, Preserve Access to Affordable Generics and Biosimilars Act S. 1435, Affordable Prescriptions for Patients Act of 2021 Implementation of the Transparency in Coverage Final Rule; Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Centers for Medicare & Medicaid Services, Department of Health and Human Services (85 Fed. Reg. 72,158 - 72,310, November 12, 2020) Interim final rule, Most Favored Nation (MFN) Model (85 Fed. Reg. 76,180-76,259, November 27, 2020) Various issues relating to Patient Protection and Affordable Care Act (P.L. 111-148) and the Health Care and Education Affordability Reconciliation Act of 2010 (P.L. 111-152), including the employer-sponsored health care system, implementation of regulatory process, provider network adequacy, delivery system reform, health savings account (HSAs), health reimbursement account (HRAs), and flexible spending account (FSAs) changes, IPAB, employer mandate, reporting requirements for issuers and applicable large employers, premium stabilization programs, medical loss ratio, medical malpractice reform, exchanges, the impact on small business; coronavirus pandemic; vaccine distribution, PPE, testing, medications and treatments, and vaccination incentives; digital health credentials; vaccine diplomacy; 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; Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors; implementation of the American Rescue Plan Act (P.L. 117-2); balance or surprise billing and related issues; single-payer health care options; health reimbursement arrangements and other account-based group health plans; Health and Human Services international pricing index (IPI) model; mental health parity; drug pricing; COBRA subsidies; Federal Trade Commissions multilateral pharmaceutical merger taskforce; telehealth, including coverage of telehealth under High Deductible Health Plans (HDHPs) and expanding telehealth options for employees; petition to HHS to grant march-in rights for the patents on the drug Xtandi; comments on IRS Notice 2020-76; Transition Relief Related to Health Coverage Reporting Required by Sections 6055 and 6056 for 2020; comments on COVID-19 Telehealth Program Application Evaluation Metrics (WC Docket No. 20-89); efforts to reform the World Health Organizations (WHO) engagement with private sector; continued U.S. membership to the World Health Organization (WHO); support for necessary market conditions to incentivize health sector investment from private sector; support for private sector involvement in health system strengthening

Client expense: $18,660,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Economic Council (NEC), Natl Security Council (NSC), 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, 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. 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. 4350, National Defense Authorization Act for Fiscal Year 2022 H.R. 4521, America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (America COMPETES) Act of 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.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. 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. 3889, Employee Rights Act 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 David Weil to be Administrator for Department of Labor, 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) 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, Employee Benefits Security Administration, U.S. Department of Labor, Notice of Proposed Rulemaking: Procedures Governing the Filing and Processing of Prohibited Transaction Exemption Applications (87 Fed. Reg. 14,722-14,751, March 15, 2022) Request for Information on Data Sources and Methods for Determining Prevailing Wage Levels for the Temporary and Permanent Employment of Certain Immigrants and Non-Immigrants in the United States, Employment and Training Administration, Department of Labor, (86 Fed. Reg. 17,343-17,346, April 2, 2021) Proposed Rule, Amendments to Agriculture Acquisition Regulations, (87 Fed. Reg. 9,005-9,021, February 17, 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; reauthorization of the Workforce Innovation and Opportunity Act (P.L. 113-128); 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; Executive Order 13950 Combating Race and Sex Stereotyping; 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; 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; 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); forthcoming regulation regarding numbers on non-immigrant foreign worker visa

Client expense: $18,660,000 · 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, Securities & Exchange Commission (SEC)