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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1201 New York Avenue NW |
Address2 | Suite 1300 |
| City | Washington |
State | DC |
Zip Code | 20005 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 6245-12
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6. House ID# 325050000
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| TYPE OF REPORT | 8. Year | 2024 |
Q1 (1/1 - 3/31) | Q2 (4/1 - 6/30) | Q3 (7/1 - 9/30) | Q4 (10/1 - 12/31) |
9. Check if this filing amends a previously filed version of this report
| 10. Check if this is a Termination Report | Termination Date |
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11. No Lobbying Issue Activity |
| INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13 | |||||||||
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| 12. Lobbying | 13. Organizations | ||||||||
| INCOME relating to lobbying activities for this reporting period was: | EXPENSE relating to lobbying activities for this reporting period were: | ||||||||
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| Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). | 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options. | ||||||||
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Method A.
Reporting amounts using LDA definitions only
Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code Method C. Reporting amounts under section 162(e) of the Internal Revenue Code |
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| Signature | Digitally Signed By: Aiken Hackett |
Date | 10/21/2024 3:05:17 PM |
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
Avian Flu
Climate Change
---FY 2025 Appropriations
---Climate Issues & impact on the agriculture and food sectors
Efforts to expand the Bio Economy & Bio Manufacturing
Farm Bill
---Farm Bill Reauthorization
Food & Ag National Security
--- S.4420/H.R.8522 - Agriculture and National Security Act Foreign Agricultural Biotechnology Laws and Regulations
---H.R.5790/S.2992: Prioritizing Offensive Agricultural Disputes and Enforcement Act
---China Biotechnology Regulations
---Mexico Decree Banning Genetically Modified Corn
Funding for the USDA
---FY 2025 Appropriations
Genetically Engineered (GE) Animals
---Climate Issues & impact on the agriculture and food sectors
---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---International Consistency of Regulations for Gene Edited Products
---USDA Proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Genetically Engineered (GE) Plants
---Climate Issues & impact on the agriculture and food 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 Regulations for Gene Edited Products
Interagency Coordination
--- H.R.8538/S.4428 - Biotechnology Oversight Coordination Act
--- H.R.8613 - The NSF and USDA Interagency Research Act
Synthetic Biotech
--- S.4413 - Synthetic Biology Advancement Act
USDA/APHIS Agricultural Biotechnology Regulations
--- H.R.1472/S.802: Plant Biostimulant Act
--- H.R.8539/S.4421- Agricultural Biotechnology Coordination Act
--- Regulatory Treatment of Gene Edited Products
--- USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
United States-Mexico-Canada Agreement (USMCA)
---Implementation of USMCA
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), Health & Human Services - Dept of (HHS), White House Office
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
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Elisabeth |
Fox |
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John |
Torres |
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Cameron |
Arterton |
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Praneel |
Jadav |
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Justin |
Pine |
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Amber |
Manko |
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Kathleen |
Callanan |
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Emily |
Michael |
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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
Avian Flu
Farm Bill
---Farm Bill Reauthorization
Genetically Engineered (GE) Animals
---Climate Issues & impact on the agriculture and food sectors
---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---International Consistency of Regulations for Gene Edited Products
---USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
Issues Relating to Medical Research and Animal Testing Models
---H.R.7248: FDA Modernization Act 3.0
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
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
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John |
Torres |
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Elisabeth |
Fox |
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Kathleen |
Callanan |
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Praneel |
Jadav |
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Justin |
Pine |
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Emily |
Michael |
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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
Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 Appropriations
---H.R.2940/S.1355: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2025 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2025 Appropriations
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2025 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for EPA - Office of Biopesticides and Pollution Prevention Division
---FY 2025 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for FDA
---FY 2025 Appropriations
---S.2780 - Medication Affordability and Patent Integrity Act
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Creating Hope Reauthorization Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2025 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for Health Resources and Services Administration (HRSA)
---FY 2025 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for National Institutes of Health
---FY 2025 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H)
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for Renewable Chemicals/Bio-based Products
---FY 2025 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022
Funding for the USDA
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX
---Implementation of the Inflation Reduction Act (IRA) of 2022
Pandemic Preparedness
--- Implementation of the Inflation Reduction Act of 2022
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, Agriculture - Dept of (USDA), Treasury - Dept of
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Emily |
Wheeler |
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Aiken |
Hackett |
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Amber |
Manko |
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Kathleen |
Callanan |
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Elisabeth |
Fox |
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Emily |
Michael |
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John |
Torres |
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Kristin |
Murphy |
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Praneel |
Jadav |
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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
---FY 2025 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022
Renewable Chemicals/Bio-based Products (Non-Funding)
---S.2452/H.R.5134: Biomanufacturing and Jobs Act
---Investment Tax Credit
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
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John |
Torres |
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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
---Oversight Pharmacy Benefit Managers
Artificial Intelligence (AI)
Bayh-Dole Act/Tech Transfer
---S.1956 Invent Here, Make Here Act of 2023 (Baldwin)
---Bayh-Dole Act
---March-In Rights
---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights
---Reasonable Pricing Clause
Compulsory Licensing
Data Privacy Issues
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---H.R. 8818: American Privacy Rights Act of 2024
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
Diversity in Patenting
---S.2566: Inventor Diversity for Economic Advancement (IDEA) Act
Drug Patenting
---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
---S. 2780 - Medication Affordability and Patient Integrity Act
---S.3583/H.R.6986: A bill to address patent thickets
---H.R.5475 Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI)
---H.R. 6275 Protecting Consumer Access to Generic Drugs Act
---FTC Orange Book Delisting Initiative
---Orange Book Listing
---PTO Proposed Rules on Terminal Disclaimer Practice
---Restrictions on Intellectual Property Rights
Foreign Drug Data Protection Law
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
Intellectual Property Enforcement
---China
---TRIPS Waiver
Patent Reform
---H.R.4575: Prohibiting Adversarial Patents Act (PAPA)
---S.79/H.R.1717: Interagency Patent Coordination and Improvement Act of 2023
---S.2140: Patent Eligibility Restoration Act (PERA)
---S.2220/H.R.4370: Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act
---Patent Litigation Reform
---The USPTO Request for Comments: Experimental Use Defense 89 Fed.Reg 53963
Patenting of Biological Inventions
---S.2140: Patent Eligibility Restoration Act (PERA)
---Section 101 Modernization
World Health Organization (WHO)
---WHO Pandemic Preparedness Accord
World Intellectual Property Office (WIPO)
---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge
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, Commerce - Dept of (DOC), Patent & Trademark Office (PTO), Health & Human Services - Dept of (HHS), Natl Security Council (NSC), White House Office, Justice - Dept of (DOJ), State - Dept of (DOS), U.S. Trade Representative (USTR)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
David |
Lachmann |
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Hans |
Sauer |
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Aiken |
Hackett |
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Kathleen |
Callanan |
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Amber |
Manko |
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Kristin |
Murphy |
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Justin |
Pine |
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Emily |
Michael |
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Praneel |
Jadav |
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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 2025 Appropriations
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit
Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture and food sectors
Biorefineries (Non-Funding)
---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023
---Climate Issues & impact on the agriculture and food sectors
Climate Change
---FY 2025 Appropriations
---Climate Issues & impact on the agriculture and food sectors
---Fighting Climate Change through Biotechnology Innovation
Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---S.2987/H.R.6413 - Agricultural Biorefinery Innovation and Opportunity Act of 2023
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture and food sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Treasury - Dept of
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
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John |
Torres |
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Elisabeth |
Fox |
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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
Farm Bill
---Farm Bill Reauthorization
Genetically Engineered (GE) Animals
---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations
---FDA Approvals, Guidance, & Regulations
---International Consistency of Regulations for Gene Edited Products
---USDA proposed Regulation of genetically engineered animals
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
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
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John |
Torres |
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Elisabeth |
Fox |
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Praneel |
Jadav |
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Justin |
Pine |
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Kathleen |
Callanan |
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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 2025 Appropriations
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit
Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture and food sectors
Biorefineries (Non-Funding)
---S.2987/H.R.6413: Agricultural Biorefinery Innovation and Opportunity Act of 2023
---Climate Issues & impact on the agriculture and food sectors
Climate Change
---FY 2025 Appropriations
---Climate Issues & impact on the agriculture and food sectors
---Mitigating Climate Change through Biotechnology Innovation
Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---S.2987/H.R.6413 - Agricultural Biorefinery Innovation and Opportunity Act of 2023
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture and food sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Agriculture - Dept of (USDA), Treasury - Dept of
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
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John |
Torres |
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Elisabeth |
Fox |
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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.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
---S1133: 350B Accountability Act
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight
---PROTECT 340B Act
---SUSTAIN 340B Act
Accelerated Approval
Access to non-human Primates (NHPs)
Artificial Intelligence (AI)
Alternative Funding Programs
Biodefense Research, Development and Procurement Issues (Non-Funding)
---H.R.3577: Medical and Health Stockpile Accountability Act of 2023
---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.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
---H.R.7085: BIOSECURE Act
---S. 4667 Risky Research Review Act
---Bio COMPETES (Draft)
---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft)
---House GOP RFI on Supply Chain
---Implementation of Medical Countermeasure Innovation Act of 2016
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---American Pandemic Preparedness Plan (AP3)
---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act)
---MCM PRV Program
---NDAA
---Reasonable Pricing Clauses in BARDA Contracts
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---VICP Loopholes
---White House National Biodefense Strategy
---WHO Pandemic Preparedness Accord
Biosimilars
---S.142: Preserve Access to Affordable Generics and Biosimilars Act
---S.2305: Biosimilar Red Tape Elimination Act
---Bio COMPETES (Draft)
---Biosimilar Copay
---House GOP RFI on Supply Chain
---Interchangeability and Pharmacy Substitution
---Reimbursement
Cell & Gene Therapy
Climate Change
---FY 2025 Appropriations
Clinical Trial Data in China
Data Privacy
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---H.R. 8818: American Privacy Rights Act of 2025
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
Diagnostics and Personalized Medicine Regulation and Oversight
Diversity & Inclusion
---Decentralized Clinical Trials
---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
Drug Evaluation and Review
---S.1906: Promising Pathway Act
---COVID-19 Lessons Learned
---FDA Hiring Flexibility
Drug Importation
Drug Manufacturing, Quality & Distribution
---Advanced Manufacturing
---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
---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
---S. 2780 Medication Affordability & Patient Integrity Act
---S.3583/H.R.6986: A bill to address patent thickets
---Affordable Prescriptions for Patients Act
---Interagency Patent Coordination and Improvement Act
---Restrictions on Intellectual Property Rights
Drug Pricing
---FY 2025 Appropriations
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---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.2408: Access to Innovative Treatments Act of 2023
---H.R.4895: Lowering Drug Costs for American Families Act
---H.R.5539/S.3131: ORPHAN Cures Act
---H.R.5547/S.476: Maintaining Investments and New Innovation (MINI) Act
---H.R.6283: DRUG Act
---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) 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: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents,
---S.2305: Biosimilar Red Tape Elimination Act
---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act
---H.R.2408: Access to Innovative Treatments Act
---CMMI Authority
---COVID-19 Pricing Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Medicare Negotiation and Competitive Licensing Act
---National Coverage Determination
---PBM Reform
---Patient Cost-Sharing and Implementation
---Strengthening Innovation in Medicare and Medicaid Act
Efforts to expand the Bio Economy & Bio Manufacturing
Foreign Drug Data Protection Laws
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 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 2025 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---MCM PRV
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2025 Appropriations
---VICP
Funding for FDA
---FY 2025 Appropriations
---Creating Hope Reauthorization Act
---Prescription Drug User Fee Act (PDUFA) VII Implementation
Funding for Health Resources and Services Administration (HRSA)
---FY 2025 Appropriations
Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2025 Appropriations
Funding for National Institutes of Health
---FY 2025 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H)
---Funding for Womens Health Research
Generic Drug Entry
---S.148: Stop STALLING Act
---S.775: Increasing Transparency in Generic Drug Applications Act
---S.4351: Enhanced Access to Affordable Medicines Act
---H.R 6973: Generic Drug Application Review Reforms
---Incentives for Generic Entry
Issues Relating to Medical Research and Animal Testing Models
---H.R.7248: FDA Modernization Act 3.0
Medicaid
---H.R.2666: The Medicaid VBPs for Patients (MVP) Act
---S.127: Pharmacy Benefit Manager Transparency Act of 2023
---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act
---Medicaid Drug Rebate Program Rule
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule
National Defense
---National Defense Authorization Act of 2025
Opioid Crisis
---H.R.4531/2933: SUPPORT Act
---Non-Opioid Analgesics
---Transparency
---Coverage and Reimbursement
Orphan Drug Issues
---H.R.3433 - Give Kids a Chance Act
---H.R.5539/S.3131: ORPHAN Cures Act
---H.R.6664: Innovation in Pediatric Drugs Act of 2023
---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Orphan Drug Tax Credit
Pandemic Preparedness
---Drug Supply Chain Management
---Implementation of the Prepare for and Respond to Existing Viruses
---Emerging New Threats and (PREVENT) Pandemics Act
---Monoclonal Antibody Coverage and Utilization
---R&D Funding for Medical Countermeasures
---Restrictions on Intellectual Property Rights
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver
---WHO Pandemic Preparedness Accord
Precision Medicine Initiative
Rare Pediatric Disease Priority Review
---H.R.7384/S4583: Creating Hope Reauthorization Act of 2024
---Helping Experts Accelerate Rare Treatments (HEART)Act
---Rare Disease Pilot Program
---Speeding Therapy Access Today (STAT) Act
Reimbursement and Coverage of Innovative Products
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.830/S.1375: HELP Copays Act
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.2408: Access to Innovative Treatments Act of 2023
---H.R.2630/S.652: SAFE STEP Act
---H.R.2666: The Medicaid VBPs for Patients (MVP) Act
---H.R.4895: Lowering Drug Costs for American Families Act
---H.R.5378: Lower Costs, More Transparency Act
---H.R.5796/S424: Protect our Seniors 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
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---Patient Cost-Sharing and Smoothing
---Protected Classes
---H.R.5260: Reduced Costs and Continued Cures Act
---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 2025 Appropriations
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.2408: Access to Innovative Treatments Act of 2023
---H.R.2630/S.652: SAFE STEP Act
---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
---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act
---Adult Immunization
---Maternal Immunization
---MCM Manufacturing & Capacity
---MCM R&D Incentives
---Monoclonal Antibody Coverage and Utilization
---National Coverage Determination
---Vaccine and Antimicrobial Resistance Product Development and Incentives
---Vaccine Injury Compensation Program
---Vaccine Quality Measure
---Vaccine Safety
---Vaccine Safety net and Vaccine Infrastructure
---Value of Vaccines and Vaccine Confidence
Vaccine Injury Compensation Program
---FY 2025 Appropriations
---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023
---H.R.5143: Vaccine Access Improvement Act of 2023
---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act
---S.3810: Countermeasure Injury Compensation Fund Amendment 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), White House Office, Natl Security Council (NSC), Justice - Dept of (DOJ), State - Dept of (DOS), Centers For Medicare and Medicaid Services (CMS), U.S. Trade Representative (USTR), Patent & Trademark Office (PTO)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
|
|
|
Hans |
Sauer |
|
|
|
Phyllis |
Arthur |
|
|
|
Kathleen |
Callanan |
|
|
|
Kristin |
Murphy |
|
|
|
David |
Lachmann |
|
|
|
Emily |
Wheeler |
|
|
|
Amber |
Manko |
|
|
|
Justin |
Pine |
|
|
|
Elisabeth |
Fox |
|
|
|
Emily |
Michael |
|
|
|
Praneel |
Jadav |
|
|
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.3631: State Strategic Stockpile Act of 2023
--- H.R. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate
---H.R.3832: Disease X Act of 2023
---H.R.7085 - BIOSECURE Act
---S.4667: Risky Research Review Act
---Bio COMPETES (Draft)
---Gain of Function Research Definition
---Gene Editing
---House GOP RFI on Supply Chain
---MCM PRV Program
---Pandemic Preparedness Plan
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---WHO Pandemic Preparedness Accord
Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 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 2025 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, White House Office, Natl Security Council (NSC), Health & Human Services - Dept of (HHS), State - Dept of (DOS), U.S. Trade Representative (USTR)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Phyllis |
Arthur |
|
|
|
Aiken |
Hackett |
|
|
|
Amber |
Manko |
|
|
|
Kathleen |
Callanan |
|
|
|
Kristin |
Murphy |
|
|
|
Emily |
Wheeler |
|
|
|
Elisabeth |
Fox |
|
|
|
Praneel |
Jadav |
|
|
|
Emily |
Michael |
|
|
|
Justin |
Pine |
|
|
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. 3820: To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate
--- H.R.3832: Disease X Act of 2023
--- H.R. 3837: Improving Public Health Preparedness Act
--- H.R. 3840: Ensuring Sufficient Supply of Testing Act, American Pandemic Preparedness Plan (AP3)
---American Pandemic Preparedness Plan (AP3)
---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft)
---Bio COMPETES (Draft)
---Executive Order on Modernizing Influenza Vaccines
---Gene Editing
---Implementation of Medical Countermeasure Innovation Act of 2016
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---MCM PRV Program
---Pandemic Preparedness Plan
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---SAFE Risky Research Act
---Tropical Disease Priority Review Voucher (PRV) Program
---Viral Gain of Function Research Moratorium Act
---White House National Biodefense Strategy
Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 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 2025 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2025 Appropriations
Funding for National Institutes of Health
---FY 2025 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H)
---Womens Health Research
Pandemic Preparedness
---MCM PRV
---R&D Funding for Medical Countermeasures
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)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Kathleen |
Callanan |
|
|
|
Emily |
Wheeler |
|
|
|
Kristin |
Murphy |
|
|
|
Aiken |
Hackett |
|
|
|
Amber |
Manko |
|
|
|
Elisabeth |
Fox |
|
|
|
Emily |
Michael |
|
|
|
Praneel |
Jadav |
|
|
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.8574 - 340B Affording Care for Communities and Ensuring a Strong Safety-net Act
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight
---S1133: 350B Accountability Act
---PROTECT 340B Act
---SUSTAIN 340B Act
Accelerated Approval
Access to non-human Primates (NHPs)
Artificial Intelligence (AI)
Alternative Funding Programs
Biodefense Research, Development and Procurement Issues (Non-Funding)
---H.R.3577: Medical and Health Stockpile Accountability Act of 2023
---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.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
---H.R.7085: BIOSECURE Act
---American Pandemic Preparedness Plan (AP3)
---Bio COMPETES (Draft)
---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft)
---House GOP RFI on Supply Chain
---Implementation of Medical Countermeasure Innovation Act of 2016
---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019
---Gain of function (Viral Gain of Function Research Moratorium Act, SAFE Risky Research Act)
---MCM PRV Program
---NDAA
---Reasonable Pricing Clauses in BARDA Contracts
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---VICP Loopholes
---White House National Biodefense Strategy
---WHO Pandemic Preparedness Accord
Biosimilars
---S.142: Preserve Access to Affordable Generics and Biosimilars Act
---S.2305: Biosimilar Red Tape Elimination Act
---Biosimilar Copay
---BSUFA Negotiations
---Implementation of BSUFA Agreement
---Interchangeability and Pharmacy Substitution
---Reimbursement
Cell & Gene Therapy
Climate Change
---FY 2025 Appropriations
Clinical Trial Data in China
Data Privacy
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---HR 8818: American Privacy Rights Act of 2024
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
Diversity & Inclusion
---Decentralized Clinical Trials
---Implementation of Prepare for and Respond to Existing Viruses, Emerging New Threats and (PREVENT) Pandemics Act
Drug Evaluation and Review
---S.1906: Promising Pathway Act
---COVID-19 Lessons Learned
---FDA Hiring Flexibility
Drug Importation
Drug Manufacturing, Quality & Distribution
---Advanced Manufacturing
---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
---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
---S.2780 - Medication Affordability and Patent Integrity Act
---S.3583/H.R.6986: A bill to address patent thickets
---Affordable Prescriptions for Patients Act
---Interagency Patent Coordination and Improvement Act
---Restrictions on Intellectual Property Rights
Drug Pricing
---FY2025 Appropriations
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---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.2408: Access to Innovative Treatments Act of 2023
---H.R.4895: Lowering Drug Costs for American Families Act
---H.R.5539/S.3131: ORPHAN Cures Act
---H.R.5547: Maintaining Investments and New Innovation (MINI) Act
---H.R.6283: DRUG Act
---H.R.7174: Ensuring Pathways to Innovative Cures (EPIC) 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: A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents,
---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act
---Access to Innovative Treatments Act
---CMMI Authority
---COVID-19 Pricing Related Provisions
---Implementation of the Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Medicare Negotiation and Competitive Licensing Act
---National Coverage Determination
---PBM Reform
---Patient Cost-Sharing and Implementation
---Strengthening Innovation in Medicare and Medicaid Act
Foreign Drug Data Protection Laws
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
---Regulatory Harmonization
Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 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 2025 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
Generic Drug Entry
---S.148: Stop STALLING Act
---S.775: Increasing Transparency in Generic Drug Applications Act
---Enhanced Access to Affordable Medicines Act
---Generic Drug Application Review Reforms
---Incentives for Generic Entry
Issues Relating to Medical Research and Animal Testing Models
---H.R.7248: FDA Modernization Act 3.0
Medicaid
---H.R.2666: The Medicaid VBPs for Patients (MVP) Act
---S.127: Pharmacy Benefit Manager Transparency Act of 2023
---S.2973: Modernizing and Ensuring PBM Accountability (MEPA) Act
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act
---Medicaid Drug Rebate Program
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule
National Defense
---National Defense Authorization Act of 2025
Opioid Crisis
---H.R.4531/S.2933: SUPPORT Act
---Non-Opioid Analgesics
---Transparency
---Coverage and Reimbursement
Orphan Drug Issues
---H.R.5539/S.3131: ORPHAN Cures Act
---H.R.6664: Innovation in Pediatric Drugs Act of 2023
---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---S.1214: Retaining Access and Restoring Exclusivity (RARE) Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Orphan Drug Tax Credit
Pandemic Preparedness
---Drug Supply Chain Management
---House GOP RFI on Supply Chain
---Implementation of the Prepare for and Respond to Existing Viruses
---Monoclonal Antibody Coverage and Utilization
---R&D Funding for Medical Countermeasures
---Restrictions on Intellectual Property Rights
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver
---WHO Pandemic Preparedness Accord
Precision Medicine Initiative
Rare Pediatric Disease Priority Review
---H.R.7384/S.4583: Creating Hope Reauthorization Act of 2024
---Helping Experts Accelerate Rare Treatments (HEART)Act
---Rare Disease Pilot Program
---Speeding Therapy Access Today (STAT) Act
Reimbursement and Coverage of Innovative Products
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.830/S.1375: HELP Copays Act
---H.R.2139/S.908: Medicare Drug Price Negotiation Act
---H.R.2148/S.909: Prescription Drug Price Relief Act
---H.R.2408: Access to Innovative Treatments Act of 2023
---H.R.2630/S.652: SAFE STEP Act
---H.R.2666: The Medicaid VBPs for Patients (MVP) Act
---H.R.4895: Lowering Drug Costs for American Families Act
---H.R.5378: Lower Costs, More Transparency Act
---Administration Rebate Rule
---CMMI Authority
---In-Home Administration of Part B Drugs
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---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 2025 Appropriations
---H.R.133: Mandating Exclusive Review of Individual Treatments (MERIT) Act
---H.R.2408: Access to Innovative Treatments Act of 2023
---H.R.2630/S.652: SAFE STEP Act
---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
---H.R.6731/S.3464: Finding Orphan-Disease Remedies with Antifungal Research and Development (FORWARD) Act
---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act
---Adult Immunization
---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 Safety Net and Vaccine Infrastructure
---Value of Vaccines and Vaccine Confidence
Vaccine Injury Compensation Program
---FY 2025 Appropriations
---H.R.5142: Vaccine Injury Compensation Modernization Act of 2023
---H.R.5143: Vaccine Access Improvement Act of 2023
---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act
---S.3810: Countermeasure Injury Compensation Fund Amendment Act
---VICP CICP (Discussion Draft)
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS), Health & Human Services - Dept of (HHS), Natl Security Council (NSC), U.S. Trade Representative (USTR), State - Dept of (DOS), Patent & Trademark Office (PTO), Justice - Dept of (DOJ), White House Office
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Aiken |
Hackett |
|
|
|
Kathleen |
Callanan |
|
|
|
Kristin |
Murphy |
|
|
|
Amber |
Manko |
|
|
|
Emily |
Michael |
|
|
|
Justin |
Pine |
|
|
|
David |
Lachmann |
|
|
|
Elisabeth |
Fox |
|
|
|
Emily |
Wheeler |
|
|
|
Hans |
Sauer |
|
|
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
---Regulatory Burden
Capital Formation Incentives
---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.2673: American Innovation and R&D Competitiveness 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
---H.R.7515: Infectious Disease Therapies Research and Innovation Act
---S.866: American Innovation and Jobs Act
---H.R.9562 Adjusting the well known seasoned issuers definition to allow for a larger financing round using
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window
---Net Operating Loss Advance Refunds
---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards
---Update public float threshold triggers to align with current market conditions
Capital Market Enhancements
---Accredited Investor Definition
---Amended Definition of Smaller Reporting Company
---JOBS Act 4.0
---Market Liquidity Proposals
---Public Float Threshold Update
---SEC Small Business Forum
---Small Business Capital Formation Enhancement Act
Mergers and Acquisitions
Reform of SEC Regulation D
---Accredited Investor Certification
Sarbanes Oxley Section 404 (b)
---Small Issuer Exemption
Small Business Innovation Research (SBIR) Program
---Reauthorization of SBIR and STTR
---Implementation of the 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, Securities & Exchange Commission (SEC)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Cameron |
Arterton |
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Amber |
Manko |
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David |
Lachmann |
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Aiken |
Hackett |
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Elisabeth |
Fox |
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Kathleen |
Callanan |
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Kristin |
Murphy |
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Emily |
Michael |
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Justin |
Pine |
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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.368: American Innovation Act of 2023
---H.R.2624: Helping Startups Continue to Grow Act
---H.R.2673: American Innovation and R&D Competitiveness Act
---H.R.2792: Small Entity Update Act
---H.R.2799: Expanding Access to Capital Act of 2023
---H.R.2797: Equal Opportunity for All Investors Act of 2023
---H.R.7515: Infectious Disease Therapies Research and Innovation Act
---H.R. 9562 Adjusting the well-known seasoned issues definition to allow for a larger financing round using
---S.866: American Innovation and Jobs Act
---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Net Operating Loss Advance Refunds
---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards
---Update public float threshold triggers to align with current market conditions
Orphan Drug Issues
Pandemic Preparedness
Renewable Chemicals/Bio-based Products (Non-Funding)
---Climate Issues & impact on the agriculture and food sectors
Research & Development Tax Credit Reforms
---H.R.2673: American Innovation and R&D Competitiveness Act
---H.R.7024: Tax Relief for American Families and Workers Act of 2024
---S.866: American Innovation and Jobs Act
---Expensing of R&D Expenditures
---NOL
---R&D Payroll Credit
Vaccine Injury Compensation Program
---FY 2025 Appropriations
---H.R.7551: Let Injured Americans Be Legally Empowered (LIABLE) Act
---S.3810: Countermeasure Injury Compensation Fund Amendment Act
---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, Securities & Exchange Commission (SEC), Agriculture - Dept of (USDA), Treasury - Dept of
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Cameron |
Arterton |
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Kathleen |
Callanan |
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Aiken |
Hackett |
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Kristin |
Murphy |
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Amber |
Manko |
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Elisabeth |
Fox |
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John |
Torres |
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Emily |
Michael |
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David |
Lachmann |
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Justin |
Pine |
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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
---China Biotechnology Regulations
---EU Ag-Biotech Policies and Regulations
---International Consistency of Regulation for Gene Edited Products
---Korea Biotechnology Regulations
---Mexico Decree Banning Genetically Modified Corn
Foreign Drug Data Protection Laws
---H.R.7085: BIOSECURE Act
---H.R.7520: Protecting Americans Data from Foreign Adversaries Act of 2024
---S.3558: A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
Genetically Engineered (GE) Animals
---International Consistency of Regulation for Gene Edited Products
Genetically Engineered (GE) Plants
---International Consistency of Regulation for Gene Edited Products
Global Supply Chain Resiliency
---B5 Coalition on Supply Chain Resiliency
---Issues Relating to Non-Human Primate Shortages
Intellectual Property International Enforcement
---China
Synthetic Biotech
US-China Trade Agreement
---Ag-Biotech Provisions
---IP Provisions
World Health Organization (WHO)
---WHO Pandemic Preparedness Accord
World Intellectual Property Office (WIPO)
---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge
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), State - Dept of (DOS), White House Office, Health & Human Services - Dept of (HHS), Natl Security Council (NSC), Agriculture - Dept of (USDA)
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
David |
Lachmann |
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Aiken |
Hackett |
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Amber |
Manko |
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Justin |
Pine |
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Kathleen |
Callanan |
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Kristin |
Murphy |
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John |
Torres |
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Emily |
Michael |
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Praneel |
Jadav |
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Elisabeth |
Fox |
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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
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21. Client new principal place of business (if different than line 20)
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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
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ISSUE UPDATE
24. General lobbying issue that no longer pertains
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AFFILIATED ORGANIZATIONS
25. Add the following affiliated organization(s)
Internet Address:
| Name | Address |
Principal Place of Business (city and state or country) |
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26. Name of each previously reported organization that is no longer affiliated with the registrant or client
| 1 | 2 | 3 |
FOREIGN ENTITIES
27. Add the following foreign entities:
| Name | Address |
Principal place of business (city and state or country) |
Amount of contribution for lobbying activities | Ownership percentage in client | ||||||||||
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% | |||||||||||||
28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization
| 1 | 3 | 5 |
| 2 | 4 | 6 |
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?
| Lobbyist Name | Description of Offense(s) |