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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 | 7/20/2023 6:14:31 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 (P.L. 117-328)
H.R. 2811: Limit, Save, Grow Act of 2023
H.R. 3746: Fiscal Responsibility Act of 2023
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)
H.R. 4368: 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. 2131: 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
H.R. 1717: Interagency Patent Coordination and Improvement Act of 2023
H.R. ___: PREVAIL Act - PTAB-related provisions
S. 79: Interagency Patent Coordination and Improvement Act of 2023
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
S. 2140: Patent Eligibility Restoration Act of 2023 - Provisions related to patents
S.___: PREVAIL Act - PTAB-related provisions
S.___: Patent Eligibility Restoration Act of 2023 - Provisions related to patents
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. 830/ S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes
H.R. 1790: Biologics Competition Act of 2023 - To direct the Secretary of Health and Human Services to evaluate the extent to which the substitution of interchangeable biological products is impacted by differences between the system for determining a biological product to be interchangeable and the system for assigning therapeutic equivalence ratings to drugs, and for other purposes
H.R. 2500: Protecting Americans from Unsafe Drugs Act of 2023
H.R. 2679: Pharmacy Benefit Manager Accountability Act
H.R. 2816: Pharmacy Benefit Manager Sunshine and Accountability Act
H.R. 2940/S 1355 PASTEUR Act/Incentives to increase novel antibiotic medicines
H.R. 2880: Protecting Patients Against PBM Abuses Act
H.R. 3008: Drug Shortage Prevention Act of 2023
H.R. 3281: Transparent PRICE Act
H.R. 3285: Fairness for Patient Medications Act
H.R. 3290: To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program/Transparency Legislation
H.R. 3433: Give Kids a Chance Act of 2023
H.R. 3561: Promoting Access to Treatments and Increasing Extremely Needed Transparency Act of 2023 or PATIENT Act of 2023
H.R. 3791: Improving DATA in Public Health Act
H.R. 3793: Ensuring Access to Lifesaving Drugs Act of 2023
H.R. 3810: Drug Origin Transparency Act of 2023
H.R. 4390: Protect 340B Act - Provisions related to 340B Program (117th Congress)
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)/Implementation of $0 Vaccine co-pay; maximum fair price provisions
H.R. 7032: Increasing Transparency in Generic Drug Applications Act of 2022 - 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) (117th Congress)
H.R. 7653: Modern Authentication of Pharmaceuticals Act of 2022 (117th Congress)
S. 6: Biosimilar Red Tape Elimination Act (117th Congress)
S. 113: Prescription Pricing for the People Act of 2023 - Provisions related to PBMs
S. 127: Pharmacy Benefit Manager Transparency Act of 2023 - Provisions related to PBMs
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. 476: Maintaining Investments in New Innovation Act
S. 775: Increasing Transparency in Generic Drug Applications Act
S. 1128: Ensuring Access to Generic Medications Act
S. 898: Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Provisions related to drug pricing (117th Congress)
S. 1967: Patients Before Middlemen (PBM Act)
S. 1067: Ensuring Timely Access to Generics Act of 2023
S. 1114: Expanding Access to Low-Cost Generics Act 2023
S. 1214: RARE Act - To set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions
S. 1264: SMART Prices Act - Provisions related to drug pricing reform
S. 1339: Pharmacy Benefit Manager Reform Act - Provisions related to PBMs
S. 1355: PASTEUR Act of 2023 - Provisions related to antimicrobial resistance policy issues
S. 1375: HELP Copays Act - To amend title XXVII of the Public Health Service Act to apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans, and for other purposes
S. 1542: Delinking Revenue from Unfair Gouging Act or DRUG Act - Provisions related to PBMs
S. 3799: Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act or PREVENT Pandemics Act (117th Congress)
Pharmacy Benefit Manager reform and policy issues
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)
Cancer Moonshot Initiative
21st Century Cures 2.0
Drug cost and pricing policy issues
Principles for drug pricing reform
Drug importation policy issues
Accelerated approval policy issues
FDA regulatory approval authority policy issues
Competition policy issues
Orphan Drug Act policy issues
Antimicrobial resistance (AMR) policy issues
Mental health policy issues
High deductible health plans/HSA policy issues
Supply chain policy issues
Real world evidence policy issues
Clinical trial diversity policy issues
Prescription drug abuse policy issues
340B 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
Cybersecurity policy issues
Anticounterfeiting policy issues
Chronic Kidney Disease Improvement in Research and Treatment Act.
H.R.2534 - PROTECT 340B Act of 2023
House Draft Language for PAHPA Reauthorization
HR 3665 - Defending American Jobs and Investment Act
Senate Draft Language for PAHPA Reauthorization
Pandemic and All Hazards Preparedness Act reauthorization (discussion draft)
Labor HHS appropriations (ongoing discussion)
Under Taxed Profit Rule, Ways and Means Committee discussion
Vaccine Injury Compensation Program reform discussion
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. 2666: Medicaid VBPs for Patients Act or MVP Act
H.R. 5376: Inflation Reduction Act of 2022 (P.L. 117-169)
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
Insulin policy issues
Value-based purchasing arrangements policy issues
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) and model policy issues
CMMI Cell and Gene Therapy Access Model
Medicaid rebates and waiver policy issues
CMS Guidance on the Medicare Drug Price Negotiation Program: Initial Memorandum [ ] IPAY 2026 and Solicitation of Comments
CMS Medicare Drug Price Negotiation Revised Guidance
CMS Guidance on Medicare Part B and D Inflation Rebates
Medicaid Drug Rebate Program Proposed rule (CMS-2434-P)
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. 3858: No Free TRIPS Act
S. 1834: No Free TRIPS Act
S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 (117th Congress)
S. __: Medical Supply Chain Resiliency Act
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:
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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:
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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) |