PREPARE ACT of 2021

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Client expense: $1,760,000 · 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), Office of Management & Budget (OMB), SENATE, White House Office

PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity

Client expense: $190,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). H.R. 2617: Consolidated Appropriations Act, 2023 Making consolidated appropriations for the fiscal year ending September 30, 2023, and for providing emergency assistance for the situation in Ukraine, and for other purposes (provisions relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing and the authorization of the Advanced Research Projects Agency-Health). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. White House and Executive Branch implementation of the CHIPS and Science Act.

Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) H.R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 (Provisions Related to Health and Human Services) S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023(Provisions Related to Health and Human Services) H.R.2617, FY2023 Consolidated Appropriations Act (Includes 12 reg. approps bills by division and other matters)

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity

Client expense: $190,000 · Firm income: Not reported

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

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing). H.R. 4346: CHIPS and Science Act Vehicle for bipartisan legislation to support domestic semiconductor research and development and reauthorize major science agencies (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). S. 4900 SBIR and STTR Extension Act of 2022 A bill to reauthorize the SBIR and STTR programs and pilot programs, and for other purposes (ALL). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. Pending federal legislation to enhance university climate research, service, and resiliency.

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) Biosimilar approval and reimbursement policy issues BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Co-pay accumulator programs COVID-19 Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues FY 2023 Appropriations H.R.2471, Consolidated Appropriations Act for FY 2022 H.R.2815, The BIOSIM Act H.R. 4390 - Protect 340B Act of 2021 H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform H.R. 5376 - Inflation Reduction Act H.R. 5801 - HELP Co-pays Act H.R. 7389 - MVP Act H.R. 6584 - DEPICT Act Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA H.R 7667 - Food and Drug Amendments Act of 2022 S.4348 - FDASLA Act of 2022 Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act S. 2837 - 340B Accountability Act 2021 Pharmacy benefit manager policy issues Cancer Moonshot

Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) H.R. 8295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023 (Provisions Related to Health and Human Services) S. 4659, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2023(Provisions Related to Health and Human Services)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to university centers of excellence in advanced and continuous pharmaceutical manufacturing). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, university centers of excellence in advanced and continuous pharmaceutical manufacturing, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). Federal policy changes regarding fetal tissue research, biomedical research involving animals, research security, and facilities and administrative costs associated with research grants. Pending federal legislation to enhance university climate research, service, and resiliency.

PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity

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

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

Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) Fiscal Year 2023 Labor, Health and Human Services, and Education Appropriations Bill (Provisions Related to Health and Human Services)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity

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

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

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues WTO TRIPS waiver

H.R. 869 and S. 289: Research Investment to Spark the Economy (RISE) Act of 2021 To authorize appropriations to offset costs resulting from reductions in research productivity in connection with the Coronavirus Disease 2019 (COVID-19), and for other purposes (ALL). H.R. 1160: Intelligence on Nefarious Foreign Leaders Using Education Networks for Corrupt Enrichment (INFLUENCE) Act To amend the Higher Education Act of 1965 to improve protections against foreign influence at institutions of higher education, and for other purposes (ALL). S. 1260 and H.R. 2731: United States Innovation and Competition Act of 2021 A bill to establish a new Directorate for Technology and Innovation in the National Science Foundation, to establish a regional technology hub program, to require a strategy and report on economic security, science, research, innovation, manufacturing, and job creation, to establish a critical supply chain resiliency program, and for other purposes (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education). H.R. 4521: America Creating Opportunities for Manufacturing, Pre-Eminence in Technology, and Economic Strength (COMPETES) Act of 2022 Vehicle for the Houses comprehensive innovation and competitiveness legislation (provisions relating to funding for the National Science Foundation, NASA, and the Departments of Commerce and Energy; provisions on research and development and foreign gift/contract reporting at U.S. institutions of higher education; immigration provisions relating to advanced degree holders from U.S. institutions of higher education; and provision relating to advanced and continuous pharmaceutical manufacturing university centers of excellence). S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act A bill to prepare for, and respond to, existing viruses, emerging new threats, and pandemics (provisions relating to the creation of the Advanced Research Projects Agency-Health, advanced and continuous pharmaceutical manufacturing university centers of excellence, pandemic preparedness university centers of excellence, and research at regional biocontainment labs). H.R. 5585: Advanced Research Project Agency-Health Act To establish the Advanced Research Projects Agency-Health, and for other purposes (ALL). H.R. 6000: Cures 2.0 Act To continue the acceleration of the discovery, development, and delivery of 21st century cures, and for other purposes (provision relating to the creation of the Advanced Research Projects Agency-Health). H.R. 2225: National Science Foundation for the Future Act To authorize appropriations for fiscal years 2022, 2023, 2024, 2025, and 2026 for the National Science Foundation, and for other purposes (ALL). H.R. 3593: Department of Energy Science for the Future Act To provide guidance for and investment in the research and development activities of the Department of Energy Office of Science, and for other purposes (ALL). H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 To amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). S. 2589: Securing Americas Medicine Cabinet Act of 2021 A bill to amend the 21st Century Cures Act to provide for designation of institutions of higher education that provide research, data, and leadership on advanced and continuous manufacturing as National Centers of Excellence in Continuous Pharmaceutical Manufacturing, and for other purposes (ALL). H.R. 3851: Continuous Manufacturing Research Act of 2021 To improve support for research and development of advanced pharmaceutical manufacturing techniques and workforce (ALL). H.R. 5388 and S. 2740: Promoting Readiness and Ensuring Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines (PREPARE) Act To establish a strategic active pharmaceutical ingredient reserve to maintain a domestic supply of active pharmaceutical ingredients and key starting materials needed for the manufacturing of essential generic medicines, and to build a pipeline for domestic active pharmaceutical ingredient production (ALL). Federal policy changes regarding fetal tissue research and research security.

H.R. 1829: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency H.R. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing H.R. 4521: United States Innovation and Competition Act of 2021 H.R. 5388: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains S. 2740: PREPARE Act of 2021 - Provisions related to medical supply chains and domestic manufacturing S. 2925: Strategic Planning for Emergency Medical Manufacturing Act - Provisions related to medical supply chains and domestic manufacturing Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Supply chain policy issues Russia/Ukraine policy issues WTO TRIPS waiver

Prepare Act, H.R. 5388 and S. 2740 (no specific provisions) Fiscal Year 2023 Labor, Health and Human Services, and Education Appropriations Bill (Provisions Related to Health and Human Services)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PREPARE Act H.R. 5388 and S. 2740 (no specific provisions); Administrations activities related to pharmaceutical supply chain and domestic capacity

Client expense: $140,000 · Firm income: Not reported

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

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and counterfeit policy issues Drug shortages policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Part D Benefit Re-design H.R. 6000: Cures 2.0 Act H.R.19 - Lower Costs, More Cures Act of 2021

H.R. 5388, S. 2740, PREPARE Act, Issues pertaining to pharmaceutical manufacturing of generic materials.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prepare Act, H.R. 5388 and S. 2740 (no specific provisions)

Client expense: Not reported · Firm income: $50,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

PREPARE Act H.R. 5388 and S. 2740 (no specific provisions)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Drug Pricing. Biden Executive Order on Drug Pricing. Pre-Hatch-Waxman ANDAs (PANDAs). Pharmaceutical Exclusivity. H.R.2831: The Prompt Approval of Safe Generic Drugs Act. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. 12-Year Exclusivity. Contract Genericization. 30-Month Stays. Labeling of Generic Drugs and Biosimilars. Modern Labeling. Carter Bill on Section 505(j)(10) Labeling. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Legislation to incentivize domestic manufacturing. H.R.4711: International Pharmaceutical Supply Chain Security Agreement Act of 2021. Orange Book. Drug Shortages. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. H.R.5388/S.2740: PREPARE Act. Expediting Review of Facility Changes. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Naming. Biosimilars Insulin. Pass-through Payments for Biosimilars. Cost Sharing for Biosimilars. Biosimilars Misinformation. FDA Inspections. FDA and Future Public Health Emergencies. FDA-PTO Collaboration. Buy American Proposals. Issues Related to COVID-19. Citizens Petitions. H.R.2843: STOP GAMES Act of 2021. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications.

Client expense: $490,000 · Firm income: Not reported

21st Century Cures Act 2.0 340B Drug Discount Program Advanced Research Projects Agency for Health (ARPA-H) AMP Cap Biosimilar approval and reimbursement policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions BLOCKING Act Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients Cell, gene and radioligand therapies Comprehensive Immunosuppressant Drug Coverage for Kidney Transplant Patients Act of 2020 Co-pay accumulator programs COVID-19 Defense Production Act Diversity in Clinical Trials Drug cost and pricing policy issues Drug Importation and conterfeiting policy issues Drug shortages policy issues Drug vial size policy issues FDA modernization policy issues Foreign manufacturing policy issues Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement FY 2022 Labor-HHS Appropriations H.R.1319, American Rescue Plan Act of 2021 H.R.133, Consolidated Appropriations Act for FY 2021 H.R.2815, The BIOSIM Act H.R.2855, Star Rating for Biosimilars Act H.R.3, Elijah E. Cummings Lower Drug Costs Now Act H.R.5463, Drug Pricing Transparency and Accountability Act H.R. 5260, Reduced Costs and Continued Cures Act H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021 Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 Medicaid Generics Penalty Fix Medicaid Payment Reform Notice of Benefit Payment Parameters (NBPP) Orphan Drugs Outcomes based contracting/value based arrangements Part B Home Infusion Patient assistance program policy issues PDUFA, BSUFA, GDUFA Pharmaceutical quality Pharmaceutical supply chain H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling) Priority Review Voucher (PRV) Regulatory efficiencies policy issues S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021 S.164, Advancing Education on Biosimilars Act of 2021 Transparency policy issues Vaccines White House National Biodefense Strategy H.R. 5416, The Give Kids a Chance Act Healthcare Disparities R&D Funding for Medical Countermeasures Reference Pricing in Drug Reimbursement Senate Finance Committee Drug Pricing Principles Senate HELP Pandemic Preparedness White Paper Step Therapy