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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 801 PENNSYLVANIA AVENUE, NW |
Address2 | Suite 700 |
| City | WASHINGTON |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 9204-12
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6. House ID# 335890000
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| TYPE OF REPORT | 8. Year | 2022 |
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: Courtney Piron |
Date | 1/20/2023 2:08:56 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
Advanced Research Projects Agency for Health (ARPA-H)
Biosimilars
Fiscal year 2023 Appropriations
H.R. 6833 - Continuing Appropriations
H.R.1, For the People Act of 2021
H.R.1319, American Rescue Plan Act of 2021
H.R.2471, Consolidated Appropriations Act for FY 2022
H.R.5376, Inflation Reduction Act
Importation
National Defense Authorization Act FY 2023
Prescription Drug User Fee Act (PDUFA) VII
Value of Medicine
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, White House Office, Executive Office of the President (EOP)
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 |
Leo |
Farber |
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Joseph |
McGowan |
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Taylor |
Booth |
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Nora |
Connors |
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Courtney |
Lee-Ashley |
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Courtney |
Piron |
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Seemin |
Pasha |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Bayh-Dole Act
Biopharmaceutical Intellectual Property
Biosimilars
BPCIA
Compulsory licenses
Data Exclusivity
Intellectual Property Issues in Response to coronavirus
Inter Parties Review at PTO
Patent Litigation Reform and Issues Related to Post Grant Proceedings at PTO
Patents
S.1435, Affordable Prescriptions for Patients Act of 2021
S.225, Competition and Antitrust Law Enforcement Reform Act
Section 101
H.R. 2883, the Stop Stalling Access to Affordable Medications
H.R. 2891, the Preserve Access to Affordable Generics and Biosimilars Act
H.R. 2873, the Affordable Prescriptions for Patients Through Promoting Competition Act of 2021
H.R. 2884, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
WTO TRIPS Waiver
March in rights
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 |
Leo |
Farber |
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Joseph |
McGowan |
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Taylor |
Booth |
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Nora |
Connors |
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Courtney |
Lee-Ashley |
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Courtney |
Piron |
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Seemin |
Pasha |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
21st Century Cures Act 2.0
340B Drug Discount Program
Advanced Research Projects Agency for Health (ARPA-H)
Biosimilar approval and reimbursement policy issues
BLOCKING Act
Buy American and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients
Cell, gene and radioligand therapies
Co-pay accumulator programs
COVID-19
Diversity in Clinical Trials
Drug cost and pricing policy issues
Drug Importation and counterfeiting policy issues
Drug shortages policy issues
Drug vial size policy issues
FDA modernization policy issues
Foreign manufacturing policy issues
FY 2023 Appropriations
H.R.2471, Consolidated Appropriations Act for FY 2022
H.R.3, Elijah E. Cummings Lower Drug Costs Now Act
H.R.5463, Drug Pricing Transparency and Accountability Act
H.R. 5260, Reduced Costs and Continued Cures Act
H.R. 4811, Medicare Negotiation and Competitive Licensing Act of 2021
Implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020
Medicaid Generics Penalty Fix
Medicaid Payment Reform
H.R. 5376 - Inflation Reduction Act
H.R. 5801 - HELP Co-pays Act
H.R. 7389 - MVP Act
H.R. 6584 - DEPICT Act
Notice of Benefit Payment Parameters (NBPP)
Orphan Drugs
Outcomes based contracting/value based arrangements
Part B Home Infusion
Patient assistance program policy issues
PDUFA, BSUFA, GDUFA
H.R 7667 - Food and Drug Amendments Act of 2022
S.4348 - FDASLA Act of 2022
Pharmaceutical quality
Pharmaceutical supply chain
H.R.5388/S.2740 PREPARE ACT of 2021 (API stockpiling)
Priority Review Voucher (PRV)
Regulatory efficiencies policy issues
S.1427, HR 2869 - Increasing Access to Biosimilars Act of 2021
Transparency policy issues
Vaccines
White House National Biodefense Strategy
H.R. 5416, The Give Kids a Chance Act
S. 2837 - 340B Accountability Act 2021
Pharmacy benefit manager policy issues
Cancer Moonshot
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), White House Office, Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS)
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 |
Leo |
Farber |
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Joseph |
McGowan |
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Taylor |
Booth |
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Nora |
Connors |
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Courtney |
Lee-Ashley |
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Courtney |
Piron |
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Seemin |
Pasha |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Anti-Kickback Statute policy issues
ASP reporting policy issues
Center for Medicare and Medicaid Innovation (CMMI) policy issues
Drug Pricing
Drug wastage rebates policy issues
Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics
Medicaid
Medicare Part D Negotiations
Medicare Part D Re-design and out of pocket cap
Medicaid rebates and waiver policy issues
Medicare Part A, B and D
Patient Cost-Sharing and Smoothing
Reimbursement for cell therapy products
Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals
Transparency policy issues
H.R. 5376 - Inflation Reduction Act Implementation
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), White House Office, Centers For Medicare and Medicaid Services (CMS), Office of Management & Budget (OMB), Health & Human Services - Dept of (HHS)
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 |
Leo |
Farber |
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Joseph |
McGowan |
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Taylor |
Booth |
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Nora |
Connors |
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Courtney |
Lee-Ashley |
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Courtney |
Piron |
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Seemin |
Pasha |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Administrations FY 2023 Revenue Proposals
Orphan Drug Tax
Pharmaceutical supply chain incentives
R&D Amortization
Restrict deductions of excessive interest of members of financial reporting groups for disproportionate borrowing in the United States (Sec. 163(n) & 163(o))
Tax Treaties
Thin Capitalization Rules 163(j)
U.S. Corporate Tax
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Leo |
Farber |
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Joseph |
McGowan |
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Taylor |
Booth |
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Nora |
Connors |
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Courtney |
Piron |
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Seemin |
Pasha |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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
Access to Medicines Issues
Biopharmaceutical Innovation Policies
China Agreement
Free Trade Agreements - Intellectual Property and Transparency Provisions
Global Health Issues
India, China and Canada IP and Market Access Issues
International Market Access and Intellectual Property Issues
Pharmaceutical Supply Chain
Pricing and reimbursement
Regulatory Cooperation
Tariffs
Trade Policy
US Swiss Trade Agreement
USTR Special 301 Report/National Trade Estimate
WTO IP Waiver
17. House(s) of Congress and Federal agencies Check if None
U.S. Trade Representative (USTR), U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Commerce - Dept of (DOC), State - Dept of (DOS), U.S. Agency for International Development (USAID), 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 |
Leo |
Farber |
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Joseph |
McGowan |
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Taylor |
Booth |
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Nora |
Connors |
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Courtney |
Lee-Ashley |
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Courtney |
Piron |
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Seemin |
Pasha |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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 VET
16. Specific lobbying issues
Health care collaboration opportunities
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Veterans Affairs - Dept of (VA)
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 |
Leo |
Farber |
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Courtney |
Piron |
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Joseph |
McGowan |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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 LBR
16. Specific lobbying issues
Anti-Trust Reform
The Competition and Antitrust Law Enforcement Reform Act (S.225)
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
18. Name of each individual who acted as a lobbyist in this issue area
| First Name | Last Name | Suffix | Covered Official Position (if applicable) | New |
Leo |
Farber |
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Joseph |
McGowan |
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Courtney |
Piron |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Novartis AG to the degree that public policies, either laws or regulations, commercially benefit Novartis Corporation, so too Novartis AG, as its parent, will benefit.
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) |