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 2024 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

---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

Foreign Agricultural Biotechnology Laws and Regulations
---Mexico Draft Decree Banning Genetically Modified Corn
---Mexico Import Approval Delays of Ag Biotech
---Mexico Revised NOM-187 to the WTO
---South Korea Living Modified Organisms

Funding for the USDA
---FY 2024 Appropriations
---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 & AGDUFA
---Efficient Science-Based Review of Biotech Products
---Farm Bill Reauthorization
---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
--- H.R.1472/S.802: Plant Biostimulant Act
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Farm Bill Reauthorization
---Regulatory Treatment of Gene Edited Products

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), Food & Drug Administration (FDA)

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

Antibiotic Use in Livestock
--- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter".

Genetically Engineered (GE) Animals
---ADUFA & AGDUFA
---Labeling
---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
---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, Food & Drug Administration (FDA)

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
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)
---MCM PRV Extension

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2024 Appropriations
---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

Funding for Biorefineries
---FY 2024 Appropriations

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2024 Appropriations
---Funding for Routine Immunization Infrastructure during Pandemic

Funding for FDA
---FY 2024 Appropriations
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2024 Appropriations

Funding for Health Resources and Services Administration (HRSA)
---FY 2024 Appropriations

Funding for National Institutes of Health
---FY 2024 Appropriations

Funding for Renewable Chemicals/Bio-based Products
---FY 2024 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for the USDA
---H.R.8239: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (Discussion Draft)
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX

House Budget RFI

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), Treasury - Dept of

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
---Implementation of the Inflation Reduction Act (IRA) of 2022

Renewable Chemicals/Bio-based Products (Non-Funding)
---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
---S.2452/H.R.5134: Biomanufacturing and Jobs Act

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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
---General
---FTC Oversight
---FTC Merger Guidelines
---FTC Hart Scott Rodino revised form

Bayh-Dole Act/Tech Transfer
---Bayh-Dole Act
---March-In Rights
---Reasonable Pricing Clause

Compulsory Licensing
---General

Coronavirus (COVID-19) Pandemic
--- H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress.
---Restrictions on Intellectual Property Rights
---TRIPS Waiver

Data Privacy Issues
---American Data Privacy and Protection Act
---General
---RFI

Drug Patenting
---AI
---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: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents
---H.R.2883/S.1485: Stop Stalling Access to Affordable Medications
---H.R.2891/S.1428: Preserve Access to Affordable Generics and Biosimilars Act
---Affordable Prescriptions for Patients Act
---CLEAR Patents Act
---Protecting Consumer Access to Generic Drugs Act
---Restrictions on Intellectual Property Rights
---Draft Double Patenting bill

Intellectual Property Enforcement
---TRIPS Waiver

Inter Partes Review
---Patent Eligibility Restoration Act of 2023
---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act (Discussion Draft)

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

Patenting of Biological Inventions
---Section 101 Modernization

United States-Mexico-Canada Agreement (USMCA)

US-China Trade Agreement

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), Federal Trade Commission (FTC)

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.5235: Farms to Fuselage 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
---Sustainable Aviation Fuels Tax Credit
---S.2452/H.R.5134: Biomanufacturing and Jobs Act

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
---FY 2024 Appropriations
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Fighting Climate Change through Biotechnology Innovation
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---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)

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Treasury - Dept of

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

Antibiotic Use in Livestock
--- H.R.4012: To repeal the guidance titled "CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter".

Genetically Engineered (GE) Animals
---ADUFA & AGDUFA
---Labeling
---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
---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

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.5235: Farms to Fuselage 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
---Sustainable Aviation Fuels Tax Credit
---S.2452/H.R.5134: Biomanufacturing and Jobs Act

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
---FY 2024 Appropriations
---Climate Issues & impact on the agriculture, food, and forestry sectors
---Fighting Climate Change through Biotechnology Innovation
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---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)

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Treasury - Dept of

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
---H.R.3290: 340B Drug Discount Program
---Program Implementation & Oversight
---340B Accountability Act
---General
---H.R.2534: PROTECT 340B Act of 2023
---RFI

Accelerated Approval
--- H.R.2408: Access to Innovative Treatments Act of 2023

Alternative Funding Programs
---General

Biodefense Research, Development and Procurement Issues (Non-Funding)
---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies.
---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes.
---H.R.3832: Disease X Act of 2023
---Improving Contract Transparency at BARDA Act (Discussion Draft)
---Improving Contract Transparency for the SNS Act (Discussion Draft)
---MCM PRV Program
---PHE Congressional Review Act of 2023 (Discussion Draft)
---PHEMCE Advisory Committee Act of 2023 (Discussion Draft)
---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---White House National Biodefense Strategy

Biosimilars
---S.2305: Biosimilar Red Tape Elimination Act
---Implementation and Reauthorization of the Biosimilar User Fee Act of 2022
---Interchangeability and Pharmacy Substitution
---Reimbursement
---Ensuring Access to Lower-Cost Medicines for Seniors Act

Coronavirus (COVID-19) Pandemic
---H.R.3066: Pandemics Require Evaluating, Planning, And Responding Effectively (PREPARE) Act
---S.2327: Seniors Prescription Drug Relief Act
---COVID-19 Lessons Learned
---COVID-19 Pricing-Related Provisions
---COVID-19 Vaccine Distribution
---Healthcare Disparities
---Patient Cost-Sharing and Smoothing
---R&D Funding for Medical Countermeasures
---Restrictions on Intellectual Property Rights
---Small Business Loans
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver
---WHO Pandemic Preparedness Accord

Climate Change
---Implementation of the Inflation Reduction Act (IRA) of 2022

Data Privacy
---American Data Privacy and Protection Act

Diagnostics and Personalized Medicine Regulation and Oversight

Diversity & Inclusion
---Decentralized Clinical Trials

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

Drug Importation
---General

Drug Manufacturing, Quality & Distribution
---Advanced Manufacturing
---Drug Shortages
---Supply Chain Integrity and Traceability

Drug Patenting
---AI
---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
---Restrictions on Intellectual Property Rights
---S.1128: 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
---Draft Double Patenting bill

Drug Pricing
---H.R.1790: Biologics Competition 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
---H.R.2408: Access to Innovative Treatments Act
---CMMI Authority
---COVID-19 Pricing-Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---National Coverage Determination
---S.127: Pharmacy Benefit Manager Transparency Act of 2023
---H.R.5378: Lower Costs, More Transparency Act

Foreign Drug Data Protection Laws

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act
---National Defense Authorization Act for FY 2024
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for 2020
---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Reauthorization of Pandemic and All-Hazards Preparedness Act (PAHPA)

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2024 Appropriations
---Funding for 2024-2025 Influenza Season Preparedness and Response
---Funding for Routine Immunization Infrastructure during Pandemic

Funding for FDA
---FY 2024 Appropriations
---Implementation of the Prescription Drug User Fee Act (PDUFA) VII Priorities

Funding for Health Resources and Services Administration (HRSA)
---FY 2024 Appropriations

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2024 Appropriations

Funding for National Institutes of Health
---FY 2024 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H) Act

Generic Drug Entry
---S.148: Stop STALLING Act
---Enhanced Access to Affordable Medicines Act
---S.775: 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
---Medicaid Drug Rebate Program Rule
---Value-Based Purchasing (VBP) Rule

Opioid Crisis
---H.R.4531: SUPPORT Act
---Coverage and Reimbursement
---Non-Opioid Analgesics
---FDA Reforms
---NIH Research

Orphan Drug Issues
---H.R.5539: ORPHAN Cures Act
---Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---Retaining Access and Restoring Exclusivity (RARE) Act (Discussion Draft)
---Implementation of the Inflation Reduction Act (IRA) of 2022

Precision Medicine Initiative

Rare Pediatric Disease Priority Review
---General

Reimbursement and Coverage of Innovative Products
---H.R.830/S.1375: HELP Copays Act
---H.R.2408: Access to Innovative Treatments 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.5378: Lower Costs, More Transparency Act
---S.2327: Seniors Prescription Drug Relief Act
---S.652/H.R.2630: Safe Step Act
---Administration Rebate Rule
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---In-Home Administration of Part B Drugs
---Medicare Part B Physician-Administered Products
---Lower Costs, More Cures Act
---National Coverage Determination
---Patient Cost-Sharing and Smoothing
---Protected Classes
---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.2408: Access to Innovative Treatments Act of 2023
---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act
---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023
---H.R.5143: Vaccine Access Improvement Act of 2023
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Maternal Immunization
---MCM Manufacturing & Capacity
---MCM R&D Incentives
---Monoclonal Antibody Coverage and Utilization
---National Coverage Determination
---Vaccine and Antimicrobial Resistance Product Development and Incentives
---Vaccine Injury Compensation Program
---Vaccine 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 (Discussion Draft)
---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023
---H.R.5143: Vaccine Access Improvement Act of 2023
---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)

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)
---H.R.3577: Medical and Health Stockpile Accountability Act of 2023
---H.R. 3613: Doctors at the Ready Act
---H.R.3631: State Strategic Stockpile Act of 2023
---H.R.3703: Helping Evaluate Appropriate Logistical Infrastructure for National Government (HEALING) Response Act of 2023
---H.R.3742: To direct the Comptroller General of the United States to evaluate the Federal Governments collection and sharing of public health data to respond to public health emergencies.
---H.R.3791: Improving Data Accessibility Through Advancements (DATA) in Public Health Act
---H.R.3794: Fast-Track Logistics for Acquiring Supplies in a Hurry (FLASH) Act of 2023
---H.R.3795: To amend the Public Health Service Act to require the development of a diagnostic testing preparedness plan to be used during public health emergencies, and for other purposes.
---H.R.3832: Disease X Act of 2023
---Gene Editing
---Improving Contract Transparency for the SNS Act (Discussion Draft)
---Improving Contract Transparency at BARDA Act (Discussion Draft)
---MCM PRV Program
---PHE Congressional Review Act of 2023 (Discussion Draft)
---Public Health Guidance Transparency and Accountability Act (Discussion Draft)
---Pandemic Preparedness Plan
---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---WHO Pandemic Preparedness Accord Zero Draft

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---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 Pandemic and All Hazards Preparedness Act (PAHPA)

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

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

16. Specific lobbying issues

Biodefense Research, Development and Procurement Issues (Non-Funding)
---H.R.3832: Disease X Act of 2023
---American Pandemic Preparedness Plan (AP3)
---Executive Order on Modernizing Influenza Vaccines
---Gene Editing
---Implementation of 21st Century Cures Act of 2016
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---Improving Contract Transparency for the SNS Act (Discussion Draft)
---Improving Contract Transparency at BARDA Act (Discussion Draft)
---MCM PRV Program
---Pandemic Preparedness Plan
---PHE Congressional Review Act of 2023 (Discussion Draft)
---PHEMCE Advisory Committee Act of 2023 (Discussion Draft)
---Public Health Guidance Transparency and Accountability Act (Discussion Draft)
---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)
---White House National Biodefense Strategy

Coronavirus (COVID-19) Pandemic
---FY 2024 Appropriations
---R&D Funding for Medical Countermeasures

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2024 Appropriations
---National Defense Authorization Act for FY 2024
---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2024 Appropriations
---Funding for Strategic National Stockpile
---Health Defense Operations Funding Designation
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2024 Appropriations
---Funding for Routine Immunization Infrastructure during Pandemic
---Reauthorization of Pandemic and All Hazards Preparedness Act (PAHPA)

Funding for National Institutes of Health
---FY 2024 Appropriations

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)

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
---H.R.3290: 340B Drug Discount Program
---Program Implementation & Oversight

Coronavirus (COVID-19) Pandemic
---Patient Cost-Sharing and Smoothing

Data Privacy
---General

Drug Pricing
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.4811: Medicare Negotiation and Competitive Licensing Act (Discussion Draft)
---H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
---H.R.133:Mandating Exclusive Review of Individual Treatments (MERIT) Act
---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.150: Affordable Prescriptions for Patients Act of 2023
---S.775: Increasing Transparency in Generic Drug Applications Act
---S.1067: Ensuring Timely Access to Generics of 2023
---COVID-19 Pricing-Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---National Coverage Determination

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
---Medicaid Drug Rebate Program Rule (MDRP)
---Pharmacy Benefit Manager Transparency Act
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

Reimbursement and Coverage of Innovative Products
---H.R.830/S.1375: HELP Copays Act
---H.R.2408: Access to Innovative Treatments 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.5237/H.R.5260: Reduced Costs and Continued Cures Act
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---In-Home Administration of Part B Drugs
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---New Opportunities for Value that Extend Lives (NOVEL) Act
---Patient Cost-Sharing and Smoothing
---Protected Classes
---H.R.2630/S.652: Stage Step Act
---H.R.5378: Lower Costs, More Transparency Act
---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
---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)

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.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---H.R.368: American Innovation Act of 2023
---H.R.448: Putting Investors First Act of 2023
---H.R.835: Fair Investment Opportunities for Professional Experts Act
---H.R.1579: Accredited Investor Definition Review Act
---H.R.2608: To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes.
---H.R.2610: To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes.
---H.R.2624: Helping Startups Continue to Grow Act
---H.R.2792: Small Entity Update Act
---H.R.2797: Equal Opportunity for All Investors Act of 2023
---H.R.2799: Expanding Access to Capital Act of 2023
---S.866: American Innovation and Jobs Act
---H.R.2673: American Innovation and R&D Competitiveness Act
---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

Mergers and Acquisitions

Proxy Advisory Services

Reform of SEC Regulation D

Sarbanes Oxley Section 404 (b)

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, 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 TAX

16. Specific lobbying issues

Biofuels (Non-Funding)
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Capital Formation Incentives
---H.R.3623/S.2529: Innovation and Growth Now by Investing in Tomorrow's Enterprises (IGNITE) American Innovation Act
---H.R.368: American Innovation Act of 2023
---H.R.2673: American Innovation and R&D Competitiveness Act
---H.R.2792: Small Entity Update Act
---S.866: American Innovation and Jobs 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
---JOBS Act 4.0
---Net Operating Loss Advance Refunds

Coronavirus (COVID-19) Pandemic

Orphan Drug Issues

Qualified Small Business Stock (QSBS)

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

Research & Development Tax Credit Reforms
---H.R.2673: American Innovation and R&D Competitiveness Act
---S.866: American Innovation and Jobs Act
---Expensing of R&D Expenditures
---House - Section 174 Amortization
---R&D Payroll Credit

Vaccine Injury Compensation Program
---FY 2024 Appropriations
---Countermeasure Injury Compensation Fund Amendment Act (Discussion Draft)
---H.R. 5142: Vaccine Injury Compensation Modernization Act
---H.R. 5143: 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

Foreign Agricultural Biotechnology Laws and Regulations
---International Consistency of Regulation for Gene Edited Products
---Korea Biotechnology Regulations
---Mexico Draft Decree Banning Genetically Modified Corn
---Mexico Import Approval Delays of Ag Biotech

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

Issues Relating to Non-Human Primate Shortages

United Nations

US-China Trade Agreement
---Ag-Biotech Provisions

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

World Intellectual Property Office (WIPO)
---Intergovernmental Committee on IP and Genetic Resources

World Trade Organization (WTO)
---TRIPS Waiver
---MC-12 Meeting

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

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), State - Dept of (DOS), 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

​

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