Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code AGR

16. Specific lobbying issues

Climate Change
---FY 2023 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Fighting Climate Change through Biotechnology Innovation
---Implementation of the Inflation Reduction Act (IRA) of 2022
---The Growing Climate Solutions Act

Foreign Agricultural Biotechnology Laws and Regulations
---Asynchronous Approvals
---China Biotechnology Regulations
---Mexico Draft Decree Banning Genetically Modified Corn
---Mexico Import Approval Delays of Ag Biotech

Funding for the USDA
---FY 2023 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX

Genetically Engineered (GE) Animals
---ADUFA
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---FDA Revised EIS on Genetically Engineered Salmon
---International Consistency of Regulation for Gene Edited Products
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
---Implementation of GE Salmon language in Consolidated Appropriations Act for FY 2021
---Labeling

Genetically Engineered (GE) Plants
---Climate Issues & impact on the agriculture, food, and forestry sectors
---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs)
---EPA Regulatory Approach to Gene Editing
---FDA Proposed guidance on Gene Editing
---International Consistency of Regulation for Gene Edited Products

Synthetic Biotech

USDA/APHIS Agricultural Biotechnology Regulations
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Farm Bill Reauthorization
---Regulatory Treatment of Gene Edited Products
---The Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) Rule under the Plant Protection Act
---USDA Part 340 Draft Rule
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), U.S. Trade Representative (USTR), Food & Drug Administration (FDA), Environmental Protection Agency (EPA), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ANI

16. Specific lobbying issues

Genetically Engineered (GE) Animals
---ADUFA
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---FDA Revised EIS on Genetically Engineered Salmon
---International Consistency of Regulation for Gene Edited Products
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Issues Relating to Non-Human Primate Shortages

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), Food & Drug Administration (FDA), Environmental Protection Agency (EPA), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

Coronavirus (COVID-19) Pandemic
---H.R.2617: Consolidated Appropriations Act of 2023
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.7900: National Defense Authorization Act for FY 2023
---S.4543: James M. Inhofe National Defense Authorization Act for FY 2023
---DISARM Act
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Implementation of USDA Discretion to Provide Support for Biofuel Producers in Consolidated Appropriations Act for FY 2021

Funding for Biorefineries
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for FDA
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Food and Drug Administration Safety and Landmark Advancements Act
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for National Institutes of Health
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for Renewable Chemicals/Bio-based Products
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for the USDA
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Natl Institutes of Health (NIH)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CHM

16. Specific lobbying issues

Funding for Renewable Chemicals/Bio-based Products
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Inflation Reduction Act (IRA) of 2022

Renewable Chemicals/Bio-based Products (Non-Funding)
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Investment Tax Credit

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

Antitrust Legislation

Bayh-Dole Act/Tech Transfer
---Bayh-Dole Act
---March-In Rights
---NIST Proposed Rulemaking on Bayh-Dole

Compulsory Licensing
---Prescription Drug Price Relief Act

Coronavirus (COVID-19) Pandemic
---Restrictions on Intellectual Property Rights
---TRIPS Waiver

Data Privacy Issues
---H.R.8152: American Data Privacy and Protection Act

Drug Patenting
---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act
---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023
---S.113: Prescription Pricing for the People Act of 2023
---S.142: Preserve Access to Affordable Generics and Biosimilars Act
---S.148: Stop STALLING Act
---S.150: Affordable Prescriptions for Patients Act of 2023
---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents
---Affordable Prescriptions for Patients Act
---CLEAR Patents Act
---Protecting Consumer Access to Generic Drugs Act
---Restrictions on Intellectual Property Rights

Intellectual Property Enforcement
---China
---TRIPS Waiver

Patent Reform
---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023
---Interagency Patent Coordination and Improvement Act
---Patent Litigation Reform
---Patent Trial and Appeal Board Reform Act

Patenting of Biological Inventions
---35 USC Section 101 on Patent Eligibility
---PTO Examination Guidelines
---Section 101 Modernization

United States-Mexico-Canada Agreement (USMCA)
---Implementation of USMCA

US-China Trade Agreement
---IP Provisions

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Patent & Trademark Office (PTO), U.S. International Trade Commission (ITC)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ENG

16. Specific lobbying issues

Biofuels (Non-Funding)
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---A Clean Fuel Standard or Low Carbon Fuel Standard
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Biorefineries (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Fighting Climate Change through Biotechnology Innovation
---The Growing Climate Solutions Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

Renewable Fuel Standard (RFS)
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), Environmental Protection Agency (EPA), White House Office, U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FOO

16. Specific lobbying issues

Genetically Engineered (GE) Animals
---ADUFA
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---FDA Revised EIS on Genetically Engineered Salmon
---International Consistency of Regulation for Gene Edited Products
---Labeling
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), Food & Drug Administration (FDA), Environmental Protection Agency (EPA), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FUE

16. Specific lobbying issues

Biofuels (Non-Funding)
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---A Clean Fuel Standard or Low Carbon Fuel Standard
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Biorefineries (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Fighting Climate Change through Biotechnology Innovation
---The Growing Climate Solutions Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

Renewable Fuel Standard (RFS)
---H.R.2617: Consolidated Appropriations Act of 2023
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Agriculture - Dept of (USDA), Environmental Protection Agency (EPA), White House Office, U.S. Trade Representative (USTR)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

340B Drug Discount Program
---340B Accountability Act
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight
---PROTECT 340B Act

Accelerated Approval

Alternative Funding Programs

Biodefense Research, Development and Procurement Issues (Non-Funding)
---American Pandemic Preparedness Plan (AP3)
---Disease X
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---MCM PRV Program
---Reauthorization of PAHPA
---Tropical Disease Priority Review Voucher (PRV) Program
---White House National Biodefense Strategy

Biosimilars
---BIOSIM Act
---BSUFA Negotiations
---Coding
---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022
---Interchangeability and Pharmacy Substitution
---Protecting Consumer Access to Generic Drugs Act
---Reimbursement

Coronavirus (COVID-19) Pandemic
---H.R.834: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act
---H.R.2617: Consolidated Appropriations Act of 2023
---S.2327: Seniors Prescription Drug Relief Act
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
---S.4317: SAFE TO WORK Act
---S.4509: Vaccine And Coverage Certainty (VACC) Act
---Access to Generic Drugs Act of 2021
---COVID-19 Lessons Learned
---COVID-19 Pricing-Related Provisions
---COVID-19 Vaccine Distribution
---Defense Production Act (DPA)
---Drug Supply Chain Management
---Healthcare Disparities
---Medicare Reimbursement Policies
---Monoclonal Antibody Coverage and Utilization
---Patient Cost-Sharing and Smoothing
---R&D Funding for Medical Countermeasures
---Restrictions on Intellectual Property Rights
---Senate HELP Pandemic Preparedness White Paper
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver
---WHO Pandemic Preparedness Accord

Climate Change
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Inflation Reduction Act (IRA) of 2022

Data Privacy
---H.R.8152: American Data Privacy and Protection Act

Diagnostics and Personalized Medicine Regulation and Oversight

Diversity & Inclusion
---S.3799: Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
---Decentralized Clinical Trials

Drug Evaluation and Review
---COVID-19 Lessons Learned
---FDA Management and Financial Accountability

Drug Importation

Drug Manufacturing, Quality & Distribution
---Advanced Manufacturing
---Counterfeiting
---Drug Shortages
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Supply Chain Integrity and Traceability

Drug Patenting
---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications
---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act
---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023
---S.113: Prescription Pricing for the People Act of 2023
---S.142: Preserve Access to Affordable Generics and Biosimilars Act
---S.148: Stop STALLING Act
---S.150: Affordable Prescriptions for Patients Act of 2023
---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents
---Affordable Prescriptions for Patients Act
---Interagency Patent Coordination and Improvement Act
---Restrictions on Intellectual Property Rights

Drug Pricing
---H.R.1790: Biologics Competition Act of 2023
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.2617: Consolidated Appropriations Act of 2023
---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023
---S.113: Prescription Pricing for the People Act of 2023
---S.142: Preserve Access to Affordable Generics and Biosimilars Act
---S.148: Stop STALLING Act
---S.150: Affordable Prescriptions for Patients Act of 2023
---S.775: Increasing Transparency in Generic Drug Application
---S.1067: Ensuring Timely Access to Generics
---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents
---Access to Innovative Treatments Act
---Affordable Prescriptions for Patients Act
---COVID-19 Pricing-Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Lower Costs, More Cures Act
---National Coverage Determination
---Pharmacy Benefit Manager Transparency Act
---Prescription Pricing for the People Act

Foreign Drug Data Protection Laws

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---National Defense Authorization Act for FY 2023
---DISARM Act
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

Funding for FDA
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---S.4348: Food and Drug Administration Safety and Landmark Advancements Act of 2022
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---H.R.2617: Consolidated Appropriations Act of 2023

Funding for National Institutes of Health
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023

Generic Drug Entry
---S.148: Stop STALLING Act
---Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act
---Enhanced Access to Affordable Medicines Act
---Generic Drug Application Review Reforms
---Increasing Transparency in Generic Drug Applications Act
---Incentives for Generic Entry

Medicaid
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Medicaid VBPs for Patients (MVP) Act
---Pharmacy Benefit Manager Transparency Act
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

Opioid Crisis
---Coverage and Reimbursement
---Non-Opioid Analgesics

Orphan Drug Issues
---H.R.5566: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---S.4185: Retaining Access and Restoring Exclusivity (RARE) Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Orphan Drug Tax Credit

Rare Pediatric Disease Priority Review
---H.R.6888/S.4071: Helping Experts Accelerate Rare Treatments (HEART) Act
---H.R.1730: Speeding Therapy Access Today (STAT) Act

Reimbursement and Coverage of Innovative Products
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---S.2327: Seniors Prescription Drug Relief Act
---Access to Innovative Treatments Act
---Administration Rebate Rule
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---In-Home Administration of Part B Drugs
---Lower Costs, More Cures Act
---National Coverage Determination
---Patient Cost-Sharing and Smoothing

Vaccines and Infectious Diseases
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---S.4509: Vaccine and Coverage Certainty (VACC) Act
---Access to Innovative Treatments Act
---Adult Immunization
---DISARM Act
---Maternal Immunization
---MCM Manufacturing & Capacity
---MCM R&D Incentives
---Monoclonal Antibody Coverage and Utilization
---National Coverage Determination
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)
---Vaccine and Antimicrobial Resistance Product Development and Incentives
---Vaccine Injury Compensation Modernization Act
---Vaccine Injury Compensation Program
---Vaccine Quality Measure
---Vaccine Safety

Vaccine Injury Compensation Program
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---S.3810: Countermeasure Injury Compensation Fund Amendment Act
---Vaccine Access Improvement Act
---Vaccine Injury Compensation Modernization Act
---VICP CICP (Discussion Draft)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), White House Office, Centers For Medicare and Medicaid Services (CMS), Natl Security Council (NSC), Patent & Trademark Office (PTO), Office of Science & Technology Policy (OSTP), State - Dept of (DOS), U.S. Trade Representative (USTR), U.S. International Trade Commission (ITC)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HOM

16. Specific lobbying issues

Biodefense Research, Development and Procurement Issues (Non-Funding)
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Pandemic Preparedness Plan
---Reauthorization of PAHPA
---Tropical Disease Priority Review Voucher (PRV) Program
---White House National Biodefense Strategy
---WHO Pandemic Preparedness Accord Zero Draft

Funding for Antimicrobial Resistance (AMR) Programs
---H.R.2617: Consolidated Appropriations Act of 2023
---DISARM Act
---National Defense Authorization Act for FY 2023
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), White House Office, Natl Security Council (NSC), State - Dept of (DOS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MED

16. Specific lobbying issues

Biodefense Research, Development and Procurement Issues (Non-Funding)
---American Pandemic Preparedness Plan
---Executive Order on Modernizing Influenza Vaccines
---Gene Editing
---Implementation of 21st Century Cures Act of 2016
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of Medical Countermeasure Innovation Act of 2016
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---Reauthorization of PAHPA
---Tropical Disease Priority Review Voucher (PRV) Program
---White House National Biodefense Strategy

Coronavirus (COVID-19) Pandemic
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---R&D Funding for Medical Countermeasures
---Senate HELP Pandemic Preparedness White Paper
---Temporarily Refundable R&D Credit

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---DISARM Act
---National Defense Authorization Act for FY 2023
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR)

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of PAHPA

Funding for National Institutes of Health
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Advanced Research Projects Agency for Health (ARPA-H) Act

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2023 Appropriations
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Funding for 2022-2023 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), White House Office, Natl Institutes of Health (NIH), Natl Security Council (NSC)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

340B Drug Discount Program
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight

Coronavirus (COVID-19) Pandemic
---COVID-19 Pricing-Related Provisions
---Patient Cost-Sharing and Smoothing
---Seniors Prescription Drug Relief Act

Data Privacy
---H.R.8152: American Data Privacy and Protection Act

Drug Pricing
---H.R.1790: Biologics Competition Act of 2023
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.4811: Medicare Negotiation and Competitive Licensing Act
---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.7667: The Food and Drug Amendments of 2022
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023
---S.113: Prescription Pricing for the People Act of 2023
---S.127: Pharmacy Benefit Manager Transparency Act of 2023
---S.142: Preserve Access to Affordable Generics and Biosimilars Act
---S.148: Stop STALLING Act
---S.150: Affordable Prescriptions for Patients Act of 2023
---S.775: Increasing Transparency in Generic Drug Application
---S.1067: Ensuring Timely Access to Generics
---S.1128 118th Congress (2023-2024): A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents
---Access to Innovative Treatments Act
---Affordable Prescriptions for Patients Act
---CMMI Authority
---COVID-19 Pricing-Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---National Coverage Determination
---Prescription Pricing for the People Act

Medicaid
---Drug Benefit Design
---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act
---Medicaid VBPs for Patients (MVP) Act
---Pharmacy Benefit Manager Transparency Act
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

Reimbursement and Coverage of Innovative Products
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.5237/H.R.5260: Reduced Costs and Continued Cures Act
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---S.2327: Seniors Prescription Drug Relief Act
---Access to Innovative Treatments Act
---Administration Rebate Rule
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Lower Costs, More Cures Act
---Medicare Part B Physician-Administered Products
---Medicare Prescription Drug Price Negotiation Act
---National Coverage Determination
---New Opportunities for Value that Extend Lives (NOVEL) Act
---Patient Cost-Sharing and Smoothing
---Protected Classes
---Step Therapy
---Support of Patient Premiums and Cost-Sharing Obligations
---Value-based Contracting and Communications
---Value-Based Purchasing (VBP) Rule

Vaccines and Infectious Diseases
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---H.R.9127: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---Access to Innovative Treatments Act
---DISARM Act
---National Coverage Determination
---Vaccine Injury Compensation Program
---Value of vaccines and vaccine confidence
---Vaccine safety net and vaccine infrastructure

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Centers For Medicare and Medicaid Services (CMS), Patent & Trademark Office (PTO)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code SMB

16. Specific lobbying issues

Banking Policy Impacting Emerging Companies

Capital Formation Incentives
---H.R.1304/S.749: American Innovation and Jobs Act
---H.R.3448: Helping Startups Continue to Grow Act
---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---H.R.7515: Infectious Disease Therapies Research and Innovation Act of 2022
---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft)
---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft)
---Implementation of the Inflation Reduction Act (IRA) of 2022
---JOBS Act 4.0
---Net Operating Loss Advance Refunds

Capital Market Enhancements
---Accredited Investor Definition
---Amended Definition of Smaller Reporting Company
---JOBS Act 4.0
---Market Liquidity Proposals
---SEC Small Business Forum

Coronavirus (COVID-19) Pandemic
---Small Business Loans
---Temporarily Refundable R&D Credit

Mergers and Acquisitions

Proxy Advisory Services
---H.R.448: Putting Investors First Act
---Impact of Policies on Small Public Companies

Reform of SEC Regulation D
---H.R.1909: Helping Angels Lead Our Startups (HALOS) Act of 2019
---Accredited Investor Certification

Sarbanes Oxley Section 404 (b)
---Small Issuer Exemption

Small Business Innovation Research (SBIR) Program
---Implementation of SBIR and STTR Extension Act of 2022

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TAX

16. Specific lobbying issues

Capital Formation Incentives
---H.R.1304/S.749: American Innovation and Jobs Act
---H.R.3448: Helping Startups Continue to Grow Act
---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---A bill to amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities (Discussion Draft)
---A bill to amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. (Discussion Draft)
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Net Operating Loss Advance Refunds

Coronavirus (COVID-19) Pandemic

Orphan Drug Issues

Qualified Small Business Stock (QSBS)
---Draft Legislation to modify and expand the Section 1202 exclusion for gain from QSBS
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Promote expansion of credit and oppose cuts

Renewable Chemicals/Bio-based Products (Non-Funding)
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Investment Tax Credit
---Production Tax Credit

Research & Development Tax Credit Reforms
---S.866: American Innovation and Jobs Act
---A bill to amend the Internal Revenue Code of 1986 to provide for credits against tax for domestic medical and drug manufacturing and advanced medical manufacturing equipment. (Discussion Draft)
---Expensing of R&D Expenditures
---House - Section 174 Amortization
---Implementation of the Inflation Reduction Act (IRA) of 2022
---R&D Payroll Credit

Vaccine Injury Compensation Program
---FY 2023 Appropriations
---FY 2024 Appropriations
---H.R.2617: Consolidated Appropriations Act of 2023
---Countermeasure Injury Compensation Fund Amendment Act
---Vaccine Injury Compensation Modernization Act
---Vaccine Access Improvement Act
---VICP CICP (Discussion Draft)

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

CFIUS and Foreign Investment

Drug Importation

Drug Pricing
---Reference Pricing in Drug Reimbursement

Foreign Agricultural Biotechnology Laws and Regulations
---Mexico Draft Decree Banning Genetically Modified Corn
---Mexico Import Approval Delays of Ag Biotech

Intellectual Property International Enforcement
---China
---General Patent Reform
---India
---TRIPS Waiver

Issues Relating to Non-Human Primate Shortages

US-China Trade Agreement
---IP Provisions

World Health Organization (WHO)
---TRIPS Waiver
---WHO Pandemic Preparedness Accord

World Trade Organization (WTO)
---TRIPS Waiver

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Agriculture - Dept of (USDA), Patent & Trademark Office (PTO), Commerce - Dept of (DOC), Treasury - Dept of, U.S. International Trade Commission (ITC), State - Dept of (DOS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes