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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 | 2021 |
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 | 10/20/2021 5:02:24 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. 1319: American Rescue Plan Act of 2021
H.R. 4502: Labor, Health and Human Services, Education, Agriculture, Rural Development, Energy and Water Development, Financial Services and General Government, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2022
H.R. 4505: Commerce, Justice, Science, and Related Agencies Appropriations Act, 2022
H.R. 4350: National Defense Authorization Act for Fiscal Year 2022
H.R. 5376: Build Back Better Act
S. 2599: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2022
S. 2792: National Defense Authorization Act for Fiscal Year 2022
S. Con. Res. 14: A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031
CARES Act, Pub. L. 116-136
FY 2022 Presidents Budget
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 |
William |
Schuyler |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Jennifer |
Dale |
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Curtis |
Rhyne |
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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. 153: Protecting Consumer Access to Generic Drugs Act of 2021 - Provisions related to patent settlements
H.R. 1629: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
H.R. 2148: Prescription Drug Price Relief Act of 2021 - Provisions related to prescription drug pricing and march-in rights
H.R. 2853: BLOCKING Act of 2021 - Provisions related to FDA exclusivity periods
H.R. 2873: Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 - Provisions related to intellectual property and patents
H.R. 2884: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act - Provisions related to patent infringement
H.R. 2891: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 250: Fairness in Orphan Drug Exclusivity Act - Provisions related to FDA policy and orphan drugs
S. 415: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity - Provisions related to FDA policy and exclusivity
S. 1428: Preserve Access to Affordable Generics and Biosimilars Act - Provisions related to patent settlements
S. 1435: Affordable Prescriptions for Patients Act of 2021 - Provisions related to intellectual property and patents
S. 2773: Unleashing American Innovators Act or 2021 - Provisions related to USPTO policy
S. 2774: Pride in Patent Ownership Act - Provisions related to patent transparency
S. 2891: A bill to amend title 35, United States Code, to address matters relating to the Patent Trial and Appeal Board of the United States Patent and Trademark Office, and for other purposes. - Provisions related to USPTO policy
S. 2910: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes. - Provisions related to FDA exclusivity periods
Biopharmaceutical innovation and patent policy issues
Bayh-Dole march-in rights 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 |
William |
Schuyler |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Jennifer |
Dale |
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Curtis |
Rhyne |
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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. 724: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021 - Provisions related to FDA drug approval process
H.R. 832: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation
H.R. 853: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B drug discount program
H.R. 1400: COVID-19 Health Disparities Action Act of 2021 - Provisions related to COVID-19 vaccines
H.R. 1873: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
H.R.1978 - Protecting Seniors Through Immunization Act of 2021
H.R. 2181: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation
H.R. 2347: Strengthening the Vaccines for Children Program Act of 2021 - Provisions related to COVID-19 vaccines
H.R. 2565: FDA Modernization Act of 2021 - Provisions related to FDA policy and health research
H.R. 2831: Prompt Approval of Safe Generic Drugs Act- Provisions related to FDA policy and approvals
H.R. 2843: STOP GAMES Act of 2021 - Provisions related to citizen petitions
H.R. 2869: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing
H.R. 2883: Stop Stalling Access to Affordable Medications - Provisions related to citizen petitions
H.R. 3684: Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates
H.R. 3761: Promising Pathways Act - Provisions related to FDA policy
H.R. 3932: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
H.R. 4390: PROTECT 340B Act of 2021 - Provisions related to 340B drug discount program
H.R. 4418: SPIKE Act - Provisions related to prescription drug pricing transparency
H.R. 5030: DIVERSE Trials Act - To improve diversity in clinical trials and data collection for COVID-19 and future public health threats to address social determinants of health
H.R. 5416: Give Kids a Chance Act (RACE 2.0) - Provisions related to pediatric investigations
S. 154: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2021- Provisions related to FDA drug approval process
S. 164: Advancing Education on Biosimilars Act of 2021 - Provisions related to biologics and biosimilar products
S. 259: Safe and Affordable Drugs from Canada Act of 2021 - Provisions related to prescription drug importation
S. 562: Ensuring Timely Access to Generics Act of 2021 - Provisions related to citizen petitions
S. 773: A bill to enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program, and for other purposes. - Provisions related to 340B drug discount program
S. 917: Short on Competition Act - Provisions related to FDA policy and prescription drug pricing
S. 920: Affordable and Safe Prescription Drug Importation Act - Provisions related to prescription drug importation
S. 1425: Stop STALLING Act - Provisions related to citizen petitions
S. 1427: Increasing Access to Biosimilars Act of 2021 - Provisions related to biosimilars and prescription drug pricing
S. 1462: Simplifying the Generic Drug Application Process Act - Provisions related to FDA policy and approvals
S. 1644: Promising Pathway Act - Provisions related to FDA policy
S. 1645: ADAPT Act - Provisions related to FDA policy
S. 2076: PASTEUR Act of 2021 - Provisions related to antimicrobial resistance policy issues
S. 2428: False Claims Amendments Act of 2021 - Provisions related to False Claims Act
S. 2429: Administrative False Claims Act of 2021 - Provisions related to False Claims Act
S. 2706: DIVERSE Trials Act - Provisions related to FDA policy
S. 2814: Vital Medication Affordability Act - Provisions related to 340B drug discount program
S. 2837: 340B Accountability Act of 2021 - Provisions related to 340B drug discount program
21st Century Cures 2.0 (discussion draft)
American Jobs Plan
RFI for Advanced Research Projects Agency - Health (ARPA-H)
HHS PREP Act declaration relating to COVID-19
Drug cost and pricing policy issues
Principles for drug pricing reform
Drug importation policy issues
Drug counterfeiting policy issues
PDUFA reauthorization
BsUFA reauthorization
Competition policy issues
Health Advanced Research Projects Agency (HARPA) proposal
Expanded access 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
FDA modernization policy issues
340B drug discount program policy issues
Patient assistance program policy issues
Biosimilar approval and reimbursement policy issues
Drug shortages policy issues
Regulatory efficiencies policy issues
COVID-19 policy issues
Defense Production Act (DPA) policy issues
Proposed Rule; Most Favored Nation (MFN) Model (proposes to rescind the Most Favored Nation Model interim final rule with comment period)
Final Rule; Importation of Prescription Drugs
Executive Order 14036, Promoting Competitition in the American Economy (July 9, 2021)
Executive Order 14017, Americas Supply Chains (February 24, 2021)
Executive Order 14005, Ensuring the Future Is Made in All of America by All of Americas Workers (January 25, 2021)
Executive Order 14001 on a Sustainable Public Health Supply Chain (January 21, 2021)
Executive Order 13987, Organizing and Mobilizing the United States Government To Provide a Unified and Effective Response To Combat COVID-19 and To Provide United States Leadership on Global Health and Security (January 20, 2021)
Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
DSHEA 2.0
HSA/FSA eligibility for Dietary Supplements
Quit because of COVID Act
Provisions related to Medicare's noninterference clause
340B Drug Pricing Program
Veterans' Affairs issues related to product sampling
Senate Amendment to H.R. 3684, Infrastructure Investment and Jobs Act, provisions related to Medicare Part B and drug rebates
S. Con. Res. Setting forth the congressional budget for the United States Government for fiscal year 2022 and setting forth the appropriate budgetary levels for fiscal years 2023 through 2031.
House of Representatives Build Back Better Act package- Rx and tax offset provisions
Senate Build Back Better deliberations
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 |
William |
Schuyler |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alex |
Hinojosa |
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Jennifer |
Dale |
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Curtis |
Rhyne |
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Elizabeth |
Brewer |
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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. 3: Elijah E. Cummings Lower Drug Costs Now Act - Provisions related to prescription drug pricing, non-interference, and intellectual property
H.R. 19: Lower Costs, More Cures Act of 2021 - Provisions related to prescription drugs
H.R. 550: Immunization Infrastructure Modernization Act
H.R.3684 - Infrastructure Investment and Jobs Act - provisions related to vial size wastage policy
H.R.5260 - Reduced Costs and Continued Cures Act
H.R. 7614: Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2021
H.R. 7616: Defense, Commerce, Justice, Science, Energy and Water Development, Financial Services and General Government, Labor, Health and Human Services, Education, Transportation, Housing, and Urban Development Appropriations Act, 2021
H.R. 4100/S. 1712: DISARM Act of 2019 a Provisions related to antimicrobial drug development
H.R. 6222: Ensuring Affordable COVID-19 Preventive Care Act of 2020 Provisions related to prescription drug pricing and access
H.R. 1227: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference
H.R. 1976: Medicare for All Act of 2021 - Provisions related to Part D and non-interference
H.R. 2010: Public Option Deficit Reduction Act - Provisions related to Part D and non-interference
H.R. 2071: Medicare Prescription Drug Price Negotiation Act of 2021 - Provisions related to Part D and non-interference
H.R. 2139: Medicare Drug Price Negotiation Act - Provisions related to Part D and non-interference
H.R. 5260: Reduced Costs and Continued Cures Act - Provisions related to prescription drug pricing and access
H.R. 5463: Drug Pricing Transparency and Accountability Act - To increase reporting requirements and transparency requirements in the 340B Drug Pricing Program, and for other purposes
S. 386: Medicare-X Choice Act of 2021 - Provisions related to Part D and non-interference
S. 833: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Provisions related to Part D and non-interference
S. 908: Medicare Drug Price Negotiation Act - Provisions related to prescription drug pricing and non-interference
S. 983: CHOICE Act - Provisions related to Part D and non-interference
S. 1619/H.R. 2862: VACCINES Act
S. 1872/H.R. 5075: Protecting Seniors Through Immunization Act
S. 2304: Strategies To Address Antibiotic Resistance Act a Provisions related to antimicrobial resistance (AMR) and other issues
S. 4320: Coronavirus Response Additional Supplemental Appropriations Act, 2020
S. 4760/H.R. 8920: PASTEUR Act (AMR)
S. 4864/H.R. 8725: HAP Act; Medicaid financial barriers
S. 1123: PING Act - Provisions related to Part D and non-interference
S. 1287: REFUND Act of 2021 - Provisions related to Part B and vial sizes
S. 1773: Prescription Drug Pricing Dashboard Act - Provisions related to Medicare, Medicaid and prescription drug pricing transparency
S. 1898: Affordable Medications Act - Provisions related to prescription drug pricing, Part D, non-interference, Part B, and intellectual property
S. 2164: Lower Costs, More Cures Act - Provisions related to prescription drug pricing and access
S. 2327: Seniors Prescription Drug Relief Act - Provisions related to Part D, prescription drug access and pricing
Part D redesign and policy issues including non-interference and rebates policy issues
Part B policy issues
Drug cost and pricing policy issues
VA drug pricing policy issues
Transparency policy issues
Alternative payment models policy issues
Value-based purchasing arrangements policy issues
Anti-Kickback Statute policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Medicaid rebates and waiver policy issues
Medicare prescription drug payments cards and related policy issues
___ Tenncare III 1115 Medicaid Demonstration - regarding closed formulary
Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans
Final Rule; Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2022; Updates to State Innovation Waiver (Section 1332 Waiver) Implementing Regulations
Final Rule; Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
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 |
William |
Schuyler |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Jennifer |
Dale |
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Curtis |
Rhyne |
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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. 2653: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 2731: Endless Frontier Act - Provisions related to medical supply chains and domestic manufacturing
H.R. 2870: Essential Medicines Strategic Stockpile Act of 2021 - Provisions related to medical supply chains and strategic stockpiles
H.R. 3035: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3236: AMIGOS Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3683: Securing Americas Pharmaceutical Supply Chain Act - Provisions related to medical supply chains
H.R. 3694: To direct the Secretary of Health and Human Services, in consultation with the United States Trade Representative and other heads of Federal agencies, to submit to Congress a report the impact of a waiver of certain obligations of member nations under the Agreement on Trade-Related Aspects of Intellectual Property Rights on global COVID-19 vaccine access, and for other purposes. - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3788: Protecting American Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3811: TRIPP Act - Provisions related to WTO TRIPS patent waivers and intellectual property
H.R. 3851: Continuous Manufacturing Research Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 3927: MADE in America Act - Provisions related to medical supply chains and domestic manufacturing
H.R. 4121, PRO Seniors Act, provisions related to drug rebates
H.R. 4369: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
H.R. 4376: USTRx Act - Provisions related to international trade policy and manufacturing
S. 298: Pharmacy Benefit Manager Accountability Study Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency
S. 1176: Onshoring Essential Antibiotics Act - Provisions related to medical supply chains
S. 1203: MMEDS Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 1260: United States Innovation and Competition Act of 2021 - Provisions related to medical supply chains and domestic manufacturing
S. 1366: Pharmaceutical Supply Chain Defense and Enhancement Act - Provisions related to medical supply chains and domestic manufacturing
S. 1367: United States Pharmaceutical Supply Chain Review Act - Provisions related to medical supply chains and domestic manufacturing
S. 1388: Prescription Pricing for the People Act of 2021 - Provisions related to medical supply chains and prescription drug pricing transparency
S. 1683: Preventing Foreign Attempts to Erode Healthcare Innovation Act - Provisions related to WTO TRIPS patent waivers and intellectual property
S. 2495: Protecting our Pharmaceutical Supply Chain from China Act of 2021 - Provisions related to medical supply chains
Trade Agreements including USMCA and related policy issues
Biopharmaceutical innovation policy issues
nternational intellectual property and market access policy issues
Pricing and reimbursement policy issues
Supply chain policy issues
WTO TRIPS waiver
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 |
William |
Schuyler |
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Shira |
Kilcoyne |
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Michael |
Calvo |
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Philip |
Thevenet |
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Alec |
Hinojosa |
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Jennifer |
Dale |
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Curtis |
Rhyne |
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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:
| 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) |