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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1050 K STREET, NW, #800 |
Address2 |
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| City | WASHINGTON |
State | DC |
Zip Code | 20001 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 16293-12
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6. House ID# 314610000
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| TYPE OF REPORT | 8. Year | 2023 |
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: Michael J. Calvo |
Date | 4/20/2023 10:38:56 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 BUD
16. Specific lobbying issues
H.R. 2617: Consolidated Appropriations Act, 2023 (PL. 117-328)
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)
H.R. 6833: Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 - User fee reauthorization (P.L. 117-180)
S. 4543: James M. Inhofe National Defense Authorization Act for Fiscal Year 2023
H.R. ____: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024
H.R. ____: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024
H.R.___: National Defense Authorization Act for Fiscal Year 2024
S._____: National Defense Authorization Act for Fiscal Year 2024
S._____: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2024
S. ____: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2024
FY 2024 Presidents Budget Request
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Office of Management & Budget (OMB)
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 |
Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Curtis |
Rhyne |
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Amy |
Efantis |
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Monica |
Cloud |
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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
S. 79: Interagency Patent Coordination and Improvement Act of 2023 - This bill establishes the Interagency Task Force on Patents to support coordination and communication between the U.S. Patent and Trademark Office (PTO) and the Food and Drug Administration (FDA) on activities relating to patents for human drugs and biological products.
S. 142: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 150: Affordable Prescriptions for Patients Act of 2023 - Provisions related to intellectual property and patents
S. 574: Increasing Prescription Drug Competition Act - Patent-related policy issues
Biopharmaceutical innovation and patent policy issues
Bayh-Dole march-in rights policy issues
Patent thicket policy issues
Patent use codes policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, 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 |
Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Curtis |
Rhyne |
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Amy |
Efantis |
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Monica |
Cloud |
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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
H.R. 198: Drug Pricing Transparency and Accountability Act - Provisions related to the 340B Program
H.R. 382: Pandemic is Over Act - This bill terminates the COVID-19 public health emergency that was declared on January 31, 2020, on the date of the bill's enactment
H.R. 4121, PRO Seniors Act, provisions related to drug rebates
Protecting American Innovation Act, provisions related to intellectual property
PDUFA Riders provisions related to disclosure of trade secrets
H.R. 4390: Protect 340B Act - Provision related to 340B Program
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)
H.R. 7032: Increasing Transparency in Generic Drug Application Act - This bill requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).
S. 148: Stop STALLING Act - Provisions related to citizen petitions
S. 315: Taxpayer Research And Contributions Knowledge Act of 2023 or TRACK Act of 2023 - To direct the Secretary of Health and Human Services and other Federal officials to compile into a searchable database information relating to Federal support for biomedical research and development, and for other purposes.
S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing
S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)
Cancer Moonshot Initiative21st Century Cures 2.0
Drug cost and pricing policy issues
Principles for drug pricing reform
Drug importation policy issues
Competition policy issues
Orphan Drug Act policy issues
Antimicrobial resistance (AMR) policy issues
High deductible health plans/HSA policy issues
Supply chain and foreign manufacturing policy issues
Real world evidence policy issues
Clinical trial diversity policy issues
Prescription drug abuse policy issues
340B Drug Pricing Program - drug discount program policy issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
COVID-19 policy issues
Pandemic preparedness policy issues
Defense Production Act policy issues
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), Office of Management & Budget (OMB)
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 |
Michael |
Calvo |
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Philip |
Thevenet |
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Alex |
Hinojosa |
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Curtis |
Rhyne |
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Monica |
Cloud |
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Amy |
Efantis |
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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 MMM
16. Specific lobbying issues
H.R. 485: Protecting Health Care for All Patients Act of 2023 - This bill prohibits all federal health care programs, including the Federal Employees Health Benefits Program, and federally funded state health care programs (e.g., Medicaid) from using prices that are based on quality-adjusted life years (i.e., measures that discount the value of a life based on disability) to determine relevant thresholds for coverage, reimbursements, or incentive programs.
H.R. 830: Help Ensure Lower Patient Copays Act or the HELP Copays Act - This bill requires health insurance plans to apply certain payments made by, or on behalf of, a plan enrollee toward a plan's cost-sharing requirements. Specifically, plans must apply third-party payments, financial assistance, discounts, product vouchers, and other reductions in out-of-pocket expenses toward the requirements.
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)
S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs
National coverage determination policy issues
Part D redesign and policy issues including non-interference and rebates policy issues
Part B policy issues
Drug cost and pricing policy issues
Rebate policy issues
Pharmacy Benefit Manager reform and policy issues
Value-based purchasing arrangements policy issues
Center for Medicare and Medicaid Innovation (CMMI) and model policy issues
Medicaid rebates and waiver policy issues
CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments
CMS Guidance on Medicare Part B and D Inflation Rebates
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), Office of Management & Budget (OMB)
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 |
Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Curtis |
Rhyne |
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Amy |
Efantis |
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Monica |
Cloud |
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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
H.R. 4376, USTRx Act, provisions related to establishing a Chief Pharmaceutical Trade Negotiator
S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to medical supply chains and prescription drug pricing transparency
S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains
Biopharmaceutical innovation policy issues
International intellectual property and market access policy issues
Pricing and reimbursement policy issues
Supply chain policy issues
WTO TRIPS waiver policy issues
China outbound investment policy issues
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, 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 |
Shira |
Kilcoyne |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Curtis |
Rhyne |
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Amy |
Efantis |
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Monica |
Cloud |
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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) |