Preserve Access to Affordable Generics and Biosimilars Act

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $180,000 · Firm income: Not reported

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

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

Client expense: $580,000 · Firm income: Not reported

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

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Generic drug quality and FDA oversight Medicare reimbursement for biosimilars, shared savings for Part B providers S.2543 - Prescription Drug Pricing Reduction Act S. 1416 - Affordable Prescriptions for Patients Act S. 1895 - Lower Health Care Costs Act of 2019 H.R. 3 - Lower Drug Costs Now Act of 2019 H.R. 938 - BLOCKING Act of 2019 H.R. 1499 - The Protecting Consumer Access to Generic Drugs Act of 2019 Part D Formulary Design and Generic Drug Tiering H.R. 4913 - Ensuring Access to Lower-Cost Medicines for Seniors Act H.R. 4455 - BIOSIM Act H.R. 4629 - Star Rating for Biosimilars Act H.R. 6179 - Increasing Access to Biosimilars Act of 2020 S. 2723 - Mitigating Emergency Drug Shortages Act H.R. 5304 - PBM Transparency in Prescription Drug Costs Act H.R. 748 - CARES Act H.R. 6431 - Made in America Emergency Preparedness Act S. 4134 - Increasing Access to Biosimilars Act of 2020 Electronic Labeling of Prescription Drugs H.R. 133 - Consolidated Appropriations Act, 2021 H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act H.R. 8644 - Secure Americas Medicine Act of 2020 H.R. 8588 - Improving the American Drug Supply Chain Act of 2020

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

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

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act Patent eligibility reform, no specific bill

Client expense: $2,560,000 · Firm income: Not reported

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

S. 4199 Prescription Drugs Pricing Reduction Act S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $160,000 · Firm income: Not reported

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

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions H.R. 133, the Consolidated Appropriations Act of 2021, regarding all bio-pharmaceutical related provisions

Client expense: $1,090,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act

Client expense: $2,920,000 · Firm income: Not reported

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

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (H.R. 5133/H.R. 4398); H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (H.R. 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Second Look at Drug Patents Act of 2019 (S. 1617); Recall Unsafe Drugs Act of 2020 (H.R. 5578); Executive Order 13944; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393); Drug recalls, registration and listing, inspections, expiration dating and shortages, and supply chain issues; Real world evidence; Presidential Proclamation 10052 of June 22, 2020; Taxpayer Research and Coronavirus Knowledge Act of 2020 (H.R.7288); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; National Defense Authorization Act for Fiscal Year 2021 (S. 4049); Endless Frontier Act (H.R.6978 / S. 3832); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act (S.3933); Securing America From Epidemics Act (H.R.6334); The Heroes Act (H.R.6800); Securing America's Vaccines for Emergencies (H.R. 6399/S. 3715); Executive Order 13922; Executive Order 13911; Executive Order 13938; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Bayh-Dole Act; Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Prescription Drug User Fee Act reauthorization; Learnings from Pandemic; Safe Authorization for Vaccines during Emergencies Act (S.4427); Potential Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board; Executive Order 13948; Advancing Americas Interests Act (H.R. 8037); Safeguarding American Innovation Act (S. 3997); Safe to Work Act (S. 4317); 340B drug discounts.

Client expense: Not reported · Firm income: $350,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act.

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 4199 Prescription Drugs Pricing Reduction Act S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $200,000 · Firm income: Not reported

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

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

Client expense: $1,600,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3991); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act

Client expense: $2,970,000 · Firm income: Not reported

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

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3391); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Protecting Access to Biosimilars Act of 2019 (H.R.2011/S. 1140); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275); Medicare Drug Price Negotiation Act (H.R. 448); Lower Drug Costs Now Act of 2019 (H.R. 3); Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 (S.476); Fair Care Act of 2019 (H.R.1332); Prescription Drug Pricing Reduction Act of 2019 (S. 2543); Competition Prescription Act of 2019 (H.R. 3947); Fixing Global Freeloading Act (H.R. 2209); National Defense Authorization Act for Fiscal Year 2020 (S.1790); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 5133/HR 4398); STOP GAMES Act of 2019 (HR 2387); H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (HR 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Purple Book Continuity Act of 2019 (H.R. 1520); Biologic Patent Transparency Act (S. 659); Orange Book Transparency Act of 2019 (H.R. 1503); Prescription Drug Affordability and Access Act (S. 3166); Biosimilars user fees legislation; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Anticompetitive Exclusionary Conduct Prevention Act of 2020 (S. 3426); Second Look at Drug Patents Act of 2019 (S. 1617); Priority review vouchers; MODERN Labeling Act of 2020 (HR 5668); Recall Unsafe Drugs Act of 2020 (HR 5578); Buy American Executive Order; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538 / H.R.6393) Families First Coronavirus Response Act (H.R. 6201), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), Drug recalls, registration and listing, expiration dating and shortages, and supply chain issues; Real world evidence; Presidential Proclamation 10052 of June 22, 2020; Taxpayer Research and Coronavirus Knowledge Act of 2020 (H.R.7288); Biosimilars user fee legislation; Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 (HR 6260/S.3545); Make Medications Affordable by Preventing Pandemic Pricegouging Act of 2020 (H.R.7296); Strategic National Stockpile; Data Sharing; National Defense Authorization Act for Fiscal Year 2021 (HR 4049); Endless Frontier Act (H.R.6978 / S. 3832); S.Res.625 - A resolution encouraging the Government and the people of the United States to "Buy American"; Creating Helpful Incentives to Produce Semiconductors (CHIPS) for America Act (S.3933); Securing America From Epidemics Act (H.R.6334); The Heroes Act (H.R.6800); Securing America's Vaccines for Emergencies (HR 6399/S. 3715); Executive Order 13922; Executive Order 13911; Executive Order 13922; Domestic manufacturing incentives; Potential amendments to PREP Act; Bring Entrepreneurial Advancements To Consumers Here In North America Act (H.R. 6690); Protecting Americans with Preexisting Conditions Act of 2019 (H.R. 986); Bayh-Dole Act; TM Act of 2020 (S.3449 / HR 6196); Pharmaceutical Accountability, Responsibility, and Transparency Act (S.3781); Protecting Our Pharmaceutical Supply Chain from China Act of 2020 (S.3537)

Client expense: Not reported · Firm income: $420,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3199); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3991); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medicare Part D coverage and reimbursement Value of Prescription Drugs Innovative Payment Model Price Transparency Legislative proposals to change Medicare Part D Medicaid and 340B issues & drug discount program International Pricing Index Model (IPI) H.R. 1499, Protecting Consumer Access to Generic Drugs Act S. 1416, Affordable prescriptions for Patients Act S. 64, H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act NPRM: Importation of Prescription drugs

Client expense: $780,000 · Firm income: Not reported

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

P.L. 116-136, Coronavirus Aid, Relief, and Economic Security (CARES) Act - provisions related to infusion issues for Medicare patients, amendments to the Tax Cuts and Jobs Act (TCJA) and the orphan drug tax credit; Issues related to the use of plasma therapies in COVID-19 patients; H.R. 1425, The Patient Protection and Affordable Care Enhancement Act Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; The Patient Affordability, Value and Efficiency Act (not yet introduced); H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 378, H.R. 1093, The Stop Price Gouging Act - provisions related to prescription drug pricing; Discussions related to co-pay accumulators; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, S. 2546, Safe Step Act - provisions related to step therapy policy; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; H.R. 3, Lower Drug Costs Now Act of 2019 - provisions related to the establishment of programs and requirements relating to the prices of prescription drugs; H.R. 19, Lower Costs, More Cures Act of 2019 - provisions related to AMP cap removal, Medicare Part D redesign, exclusivity periods, vial wastage, drug price transparency, add-on payment and pay-fors; H.R. 3165, Mental Health Parity Compliance Act - provisions related to mental health coverage; H.R. 5201, Telemental Health Expansion Act of 2019 - provisions related to mental telehealth coverage; H.R. 5469, Pursuing Equity in Mental Health Act of 2019 - provisions related to mental health coverage; Issues related to global pharmaceutical supply chain operations and manufacturing locations; H.R. 4712, Fairness in Orphan Drug Exclusivity Act - provisions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2507, S. 2158, Newborn Screening Saves Lives Reauthorization of 2019 - provisions related to newborn screening; H.R. 6800, The Heros Act - provisions related to tax issues and plasma treatments;

Client expense: $1,330,000 · 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), Health Resources & Services Administration (HRSA), SENATE

S. 3129, Crapo The Lower Costs, More Cures Act HR 19 Walden, the Lower Costs, More Cures Act HR 5444 Underwood, Lower Insulin Costs Now Act HR 5304 Schrader, PBM Transparency in Prescription Drug Costs Act HR 4906, DeGette, Regarding the costs of insulin HR 5442, Porter, regarding drug pricing S. 2543, Prescription Drug Pricing Reduction Act HR 2296, regarding prescription drug pricing HR 3, regarding prescription drug pricing (Pelosi) HR 4455, regarding Biologics in Medicare Part D S. 2543, Prescription Drug Pricing Reduction Act HR 1781, regarding access to data for MedPAC and MACPAC HR 2113, regarding drug price transparency HR 2374, regarding generic drugs and citizens petitions HR 2375, regarding pay for delay agreements and generic drugs HR 2376, regarding the Federal Trade Commissions role in assuring competition in the pharmaceutical supply chain HR 2064, regarding reporting of prescription drug samples given to physicians by manufacturers HR 478 and S. 61, regarding drug reimportation HR 965 and S 340, regarding abuse of Risk Evaluation and Mitigation Strategies (REMS) (CREATES Act) HR 1499, regarding pay for delay in pharmaceutical markets HR 1503, regarding the FDA Orange Book HR 1520, regarding the FDA Purple Book HR 938, regarding generic drug approvals HR 2113, regarding drug pricing transparency

Client expense: $160,000 · Firm income: Not reported

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

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748) The HEROES Act (HR 6800)

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1499, Protecting Consumer Access to Generic Drugs Act, regarding all bio-pharmaceutical related provisions H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019, regarding all bio-pharmaceutical related provisions H.R. 1344, Competitive DRUGS Act, regarding all bio-pharmaceutical related provisions. H.R. 2279/S. 2546, Safe Step Act of 2019, regarding all bio-pharmaceutical related provisions S. 64, Preserve Access to Affordable Generics and Biosimilars Act,regarding all bio-pharmaceutical related provisions. H.R.2375, Preserve Access to Affordable Generics and Biosimilars Act, regarding all bio-pharmaceutical related provisions H.R. 2387, STOP GAMES Act, regarding all bio-pharmaceutical related provisions H.R. 3199, TERM Act, regarding all bio-pharmaceutical related provisions S. 440, PACED Act, regarding all bio-pharmaceutical related provisions S. 1224/H.R.2374, Stop STALLING Act, regarding all bio-pharmaceutical related provisions S.1416, Affordable Prescriptions for Patients Act, regarding all bio-pharmaceutical related provisions S. 1617, Second Look at Drug Patents Act, regarding all bio-pharmaceutical related provisions

Client expense: $2,160,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency.

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support reintroduction of Patients Access to Treatments Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support sunscreen related provisions in H.R. 269, the Pandemic & All Hazards Preparedness & Advancing Innovation Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for access to dermatological procedures for veterans through the VA MISSION Act (Public Law 115-182). Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548).

Client expense: $410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 124 Preserve Access to Affordable Generics Act Issues related to drug patents and exclusivities (no bill) H.R. 1520, Purple Book Continuity Act of 2019 H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019 S. 1224, The Stop STALLING Act S. 1416, The Affordable Prescriptions for Patients Act, on product hopping and patent thicketing S.659 - the Biologics Patent Transparency Act H.R. 938 Bringing Low-cost Options and Competition while Keeping Incentives for New Generics H.R. 5133 Affordable Prescriptions for Patients Through Promoting Competition H.R. 3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act H.R. 2374 Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act H.R. 2375 Preserve Access to Affordable Generics and Biosimilars Act

Client expense: $2,700,000 · Firm income: Not reported

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

Drug Pricing, drug shortage, drug affordability and accessibility regarding generics, H.R. 965 - CREATES Act of 2019, H.R. 2375 - Preserve Access to Affordable Generics and Biosimilars Act, H.R. 2374 - Stop STALLING Act, H.R. 2376 - Prescription Pricing for the People Act of 2019, H.R. 1503 - Orange Book Transparency Act of 2019, H.R. 1520 - Purple Book Continuity Act of 2019, COVID-19 Response

Client expense: Not reported · Firm income: $45,000

Government targets: Education, Dept of, Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office

Issues related to drug pricing H.R.1499 - Protecting Consumer Access to Generic Drugs Act of 2019 H.R.938 - BLOCKING Act of 2019 H.R.987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.965/S. 340 - CREATES Act of 2019 H.R.2375/S. 64 - Preserve Access to Affordable Generics and Biosimilars Act H.R.2374/S. 1224 - Stop STALLING Act S.1895 - Lower Health Care Costs Act S.2103 - Affordable Insulin Approvals Now Act S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 H.R.3 - Elijah E. Cummings Lower Drug Costs Now Act S.1416 - Affordable Prescriptions for Patients Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.4913 - To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes. H.R.6179 - Increasing Access to Biosimilars Act of 2020 H.R.6201 - Families First Coronavirus Response Act H.R.748 - CARES Act

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3991); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

Client expense: Not reported · Firm income: $80,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3199); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Intellectual property, data exclusivity and patent eligibility, generally; CREATES Act of 2019 (S.340)/(H.R.965); Preserve Access to Affordable Generics and Biosimilars Act (S.64)/(H.R.2375); Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (S.1224)/(H.R.2374); Affordable Prescriptions for Patients Act (S.1416); Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act (H.R. 3391); Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 4398); Protecting Consumer Access to Generic Drugs Act (H.R. 1499).

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Proposed rule on rebate safe Harbor (84 Fed. Reg. 2340); Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 (S. 2161); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); Direct to consumer advertising; Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275); Medicare Drug Price Negotiation Act (H.R. 448); Lower Drug Costs Now Act of 2019 (H.R. 3); Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 (S.476); Fair Care Act of 2019 (H.R.1332); Prescription Drug Pricing Reduction Act of 2019 (S. 2543); Competition Prescription Act of 2019 (H.R. 3947); Fixing Global Freeloading Act (H.R. 2209); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 5133/HR 4398); STOP GAMES Act of 2019 (HR 2387);; H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (HR 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Purple Book Continuity Act of 2019 (H.R. 1520); Biologic Patent Transparency Act (S. 659); Conditional Approval Act (S. 3133); Fairness in Orphan Drug Exclusivity Act (H.R. 4712 / S. 3271); Orange Book Transparency Act of 2019 (H.R. 1503); Prescription Drug Affordability and Access Act (S. 3166); Biosimilars user fees legislation; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Anticompetitive Exclusionary Conduct Prevention Act of 2020 (S. 3426); Second Look at Drug Patents Act of 2019 (S. 1617); Priority review vouchers; MODERN Labeling Act of 2020 (HR 5668); CARES Act (HR 748/S. 3548); Recall Unsafe Drugs Act of 2020 (HR 5578); Buy American Executive Order; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Mitigating Emergency Drug Shortages Act (MEDS Act) (S. 2723); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538) Families First Coronavirus Response Act (H.R. 6201), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), Drug recalls, registration and listing, shortages, and supply chain reporting; Strategic National Stockpile.

Client expense: Not reported · Firm income: $260,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Lower Health Care Costs Act (S.1895) Reauthorizing and Extending America's Community Health Act - REACH Act (H.R. 2328) Preserve Access to Affordable Generics and Biosimilars Act (S. 64/H.R. 2375) Protecting Jessica Grubbs Legacy Act (S. 1012) Overdose Prevention and Patient Safety Act (H.R. 2062) ACA Medicaid disproportionate share hospital (DSH) cuts Prescription Drug Price Transparency Act (H.R.1035) Improving Transparency and Accuracy in Medicare Part D Spending Act (H.R. 803) Short on Competition Act (S. 844) Resident Physician Shortage Act of 2019 (H.R. 1763/S. 348) FAST Generics Act (H.R. 985) The Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499) The Fair and Immediate Release of Generic Drugs Act (H.R. 1506) The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (H.R. 938) The Orange Book Transparency Act of 2019 (H.R. 1503) The Purple Book Continuity Act of 2019 (H.R. 1520) Home infusion: 50401 of the Bipartisan Budget Act of 2018 (BBA) (Pub. L. 115-123) and section 5012 of the 21st Century Cures Act of 2016 (CURES) (Pub. L. 114-255) Phair Pricing Act (H.R. 1030) Improving Seniors' Timely Access to Care Act of 2019 (H.R. 3107) The Mitigating Emergency Drug Shortages (MEDS) Act (S.2723) Accountable Care in Rural America Act (H.R. 5212) Rural ACO Improvement Act (S.2648) Helping Medicaid Offer Maternity Services (H.R. 4996) Prescription Drug Pricing Reduction Act of 2019 (S. 2543) Stop STALLING Act (H.R. 2374) Reforming Evergreening and Manipulation that Extends Drug Years Act (S. 1209) Preventing Drug Shortages Act (H.R. 6080) Protecting Jessica Grubb's Legacy Act (S. 3374) Preserving Patient Access to Home Infusion Act (H.R. 6218/S. 3457) Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) Coronavirus Aid, Relief, and Economic Security Act (H.R. 748)

Client expense: $540,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 938: BLOCKING Act of 2019 - Provisions related to 180 day generic prescription drug exclusivity H.R. 987: Strengthening Health Care and Lowering Prescription Drug Costs Act - Provisions related to prescription drug pricing, patent settlements, and other issues H.R. 1344: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 - Provisions related to patent settlements H.R. 1499: Protecting Consumer Access to Generic Drugs Act of 2019 - Provisions related to patent settlements H.R. 1503: Orange Book Transparency Act - Provisions related to prescription drug and device patent listings H.R. 1520: Purple Book Continuity Act of 2019 - Provisions related to prescription drug patent listings H.R. 2374: Stop STALLING Act - Provisions related to citizen petitions H.R. 2375: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements H.R. 2387: STOP GAMES Act of 2019 - Provisions related to citizen petitions H.R. 2455: Ensuring Timely Access to Generics Act of 2019 - Provisions related to citizen petitions H.R. 2700: Lowering Prescription Drug Costs and Extending Community Health Centers and Other Public Health Priorities Act - Provisions related to patent settlements, generic exclusivity, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 3666: STRONGER Patents Act of 2019 - Provisions related to prescription drug patents H.R. 4712: Fairness in Orphan Drug Exclusivity Act - Provisions related to prescription drug exclusivity periods H.R. 4850: Biologic Patent Transparency Act - Provisions related to prescription drug patent disclosures H.R. 5133: Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 - Provisions related to prescription drug exclusivity periods and manufacturer behavior H.R. 6196: Trademark Modernization Act of 2020 - Provisions related to trademarks S. 64: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements S. 102: Prescription Drug Price Relief Act of 2019 - Provisions related to foreign reference pricing, patents and march-in rights S. 1209: Reforming Evergreening and Manipulation that Extends Drug Years Act - Provisions related to prescription drug patents S. 1224: Stop STALLING Act - Provisions related to citizen petitions S. 1416: Affordable Prescriptions for Patients Act of 2019 - Provisions related to prescription drug patents S. 1617: Second Look at Drug Patents Act of 2019 - Provisions related to prescription drug patents S. 3449: Trademark Modernization Act of 2020 - Provisions related to trademarks Biopharmaceutical innovation and patent policy issues Trademark legislative proposals Bayh-Dole march-in rights policy issues

Client expense: $9,020,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)

Medicare Part D coverage and reimbursement Value of Prescription Drugs, Senate & House Prescription Drug Importation, Senate & House Innovative Payment Models, Senate & House, CMS Price Transparency, Senate & House Legislative proposals to change Medicare Part D Medicaid and 340B issues & drug discount program International Pricing Index Model (IPI) H.R. 1499, Protecting Consumer Access to Generic Drugs Act S. 1416, Affordable prescriptions for Patients Act S. 64, H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act NPRM: Importation of Prescription drugs

Client expense: $1,560,000 · 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

The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074) Families First Coronavirus Response Act (H.R. 6201) The Coronavirus Aid, Relief, and Economic Security Act (S. 3548) Regulatory relief in light of coronavirus FY 2021 Labor-HHS Subcommittee Appropriations bill Market stabilization/Insurance Coverage Policies (Oversight of final rules on short-term, limited duration insurance (STLDI) and Association Health Plans) Coverage proposals (U.S. v Texas; Medicare X-Choice Proposal; H.R. 1384, the Medicare for All Act of 2019; S. 1129, Medicare-for-all national health insurance program; H.R. 1384 and H.R. 2452 to create a national health insurance program; H.R. 2000, H.R. 2463, and H.R. 2085 to create a federal public option; H.R. 1277 a Medicaid buy-in; H.R. 1346 and H.R. 4527 adults aged 50-64 or qualified first responders Medicare buy in; H.R. 584 Medicaid expansion) Hospital Price Transparency (surprise medical bills; public posting of hospital charges; Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First; Final Rule on Price Transparency; Transparency in Coverage Proposed Rule) Surprise Medical Bills (S. 1895 Lower Health Care Costs Act of 2019; S. 1531 Stopping the Outrageous Practice of Surprise Medical Bills Act; S. 1266 the Protecting Patients from Surprise Medical Bills Act; S. 1497, the Health Care Price Check Act; H.R.861, the End Surprise Billing Act of 2019; S. 1688 - A bill to amend the Public Health Service Act to provide for the full disclosure of billing and service information to patients; H.R. 3502 the Protecting People from Surprise Medical Bills Act; H.R. 3630, No Surprises Act; H.R. 2328, the Reauthorizing and Extending Americas Community Health Act) 340B Drug Pricing Program Drug pricing policy and drug shortages (H.R. 3, Lower Drug Costs Now Act; S. 340/H.R. 965, CREATES Act; H.R. 1499, Protecting Consumer Access to Generic Drugs Act; H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act; H.R. 2296, the More Efficient Tools to Realize Information for Consumers (METRIC) Act; H.R. 1781, the Payment Commission Data Act of 2019; H.R. 2115, requiring PBMs to report rebate data) HIPAA policy in mental and behavioral health information sharing (H.R. 2062, Overdose Prevention and Patient Safety Act) BLOCKING Act of 2019 (H.R. 938) To amend the Internal Revenue Code of 1986 and title XI of the Social Security Act to extend appropriations and transfers to the Patient-Centered Outcomes Research Trust Fund and to extend certain health insurance fees for such transfers, and for other purposes (H.R. 3439) H.R. 2781, the Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019 H.R. 728, the Title VIII Nursing Workforce Reauthorization Act H.R. 647, the Palliative Care and Hospice Education and Training Act Hospital Star Ratings

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug Pricing, HR 2375, S 64-Preserve Access to Affordable Generics and Biosimilars Act) HR 2374/S 1224 Stop STALLING act, HR 2387-Stop GAMES act, S. 1416/HR 5133-Affordable Prescriptions for Patients Act, S2543-Prescription Drug Pricing Reduction Act, S 551-Refund Act, Coronavirus, Coronavirus Preparedness and Response Supplemental Appropriations Act (HR 6074), HR3/S 3166-Lower Drug costs now act, HR 1093/S 378-Stop Price Gouging Act, S 377/HR 1046-Medicare Negotiation and Competitive Licensing Act, H 1801-Affordable Medications Act

Client expense: $80,000 · Firm income: Not reported

Government targets: Consumer Product Safety Commission (CPSC), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, Securities & Exchange Commission (SEC)