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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 | 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. | ||||||||
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 |
Signature | Digitally Signed By: Courtney Piron |
Date | 10/20/2023 1:39:37 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
Drug Pricing
Fiscal year 2024 Appropriations
H.R. 5376, Inflation Reduction Act
Importation
National Defense Authorization Act FY 2024
Value of Medicine
CBO modeling
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), Office of Management & Budget (OMB), Congressional Budget Office (CBO)
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
Compulsory licenses
Data Exclusivity
H.R. 2883/S. 148, Stop Stalling Access to Affordable Medications
H.R. 2884/S. 150, the Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act
H.R. 2891/S. 142, the Preserve Access to Affordable Generics and Biosimilars Act
H.R. 5376, Inflation Reduction Act
S. 79, Patent Coordination and Improvement Act of 2023
S. 113, Prescription Pricing for the People Act of 2023
S. 1128, Ensuring Access to Generic Medications Act (use patents)
Intellectual Property Issues in Response to coronavirus
Patents
Reasonable Pricing Clause
Section 101
WTO TRIPS Waiver
March-In Rights
H.R. 3858/S.1834: A bill to prohibit the President from negotiating or concluding any withdrawal, suspension, waiver, or modification to the Agreement on Trade-Related Aspects of Intellectual Property Rights without explicit authorization from Congress.
Restrictions on Intellectual Property Rights
Artificial Intelligence
Affordable Prescriptions for Patients Act---CLEAR Patents Act
Protecting Consumer Access to Generic Drugs Act
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
340B Drug Discount Program
H.R. 3290, To amend title III of the Public Health Service Act to ensure transparency and oversight of the 340B drug discount program.
H.R. 2534, PROTECT 340B Act of 2023
340B Contract Pharmacy Policy
S. 1133, 340B Accountability Act
Accelerated Approval
Advanced Research Projects Agency for Health (ARPA-H)
Alternative Funding Programs
Biosimilar approval and reimbursement policy issues
Buy American Executive Order
Cancer Moonshot
Cell, gene and radioligand therapies
Co-pay accumulator programs
Diversity in Clinical Trials
Drug cost and pricing policy issues
Drug Importation and counterfeiting policy issues
Drug shortages policy issues
FDA modernization policy issues
Foreign manufacturing policy issues
Genetically Targeted Technologies
H.R. 2534, Preserving Rules Ordered for the Entities Covered Through (PROTECT) 340B Act
H.R. 2679, Pharmacy Benefits Manager Accountability Act
H.R. 5376, Inflation Reduction Act
H.R. 4822, Health Care Price Transparency Act of 2023
Inflation Reduction Act Implementation
H.R. 5416, The Give Kids a Chance Act
The Medicaid VBPs for Patients (MVP) Act
H.R. 830/S. 1375, HELP Co-pays Act
H.R. 1613, The Drug Price Transparency in Medicaid Act
H.R. 198, Drug Pricing Transparency and Accountability Act
H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency
Medicaid Payment Reform
Notice of Benefit Payment Parameters (NBPP)
Orphan drug policy issues
Outcomes based contracting/value based arrangements
Patient assistance program policy issues
PDUFA, BSUFA, GDUFA
Pharmaceutical quality
Pharmaceutical supply chain
Pharmacy benefit manager policy issues
Priority Review Voucher (PRV)
Reauthorization of PAHPA
Regulatory efficiencies policy issues
S. 652/H.R. 2630, Safe Step Act
S. 79/H.R. 1717, Interagency Patent Coordination and Improvement Act of 2023
S. 2837, 340B Accountability Act 2021
S. 476/HR. 5567 The Maintaining Investments in New Innovations (MINI) Act
H.R. 5539, ORPHAN Cures Act
S. 1246, SMART Prices Act
S. 127, The Pharmacy Benefit Manager Transparency Act of 2023
S. 1339, Pharmacy Benefit Manager Reform Act
S. 1542, Delinking Reveue from Unfair Gouging (DRUG) Act
S. 1967, Patients Before Middlemen Act
S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act
H.R. 5378, Lower Costs, More Transparency Act
H.R. 2880, Protecting Patients Against PBM Abuses Act
Step Therapy
Transparency policy issues
Utilization management issues
Health industry vertical integration
CBO modeling
340B Program Implementation & Oversight
340B Accountability Act
S. 1182: The 340B Reporting and Accountability Act
H.R.2534: PROTECT 340B Act of 2023
H.R.2408: Access to Innovative Treatments Act of 2023
H.R.1790: Biologics Competition Act of 2023
S.113: Prescription Pricing for the People Act of 2023
S.150: Affordable Prescriptions for Patients Act of 2023
Drug Benefit Design
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), Executive Office of the President (EOP), Congressional Budget Office (CBO)
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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Stacie |
Aman |
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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
H.R. 1613/S. 1038, Drug Price Transparency in Medicaid Act of 2023
H.R. 5376, Inflation Reduction Act
H.R. 2666, Medicaid for VBPs for Patients (MVP) Act
H.R. 2880, Protecting Patients Against PBM Abuses Act
H.R. 3285, Fairness for Patient Medications Act
S. 1967, Patients Before Middlemen Act
S. 2973 Modernizing and Ensuring PBM Accountability (MEPA) Act
H.R. 3561, Promoting Access to Treatments and Increasing Extremely Needed Transparency
Innovative Pharmaceuticals (including cell, gene and radioligand therapies), Biosimilars and Generics
Inflation Reduction Act Impact on Innovative Pharmaceuticals
Medicaid
Medicaid rebates and waiver policy issues
Medicare Part A, B and D
Medicare Part D Negotiations
Medicare Part D Re-design and out of pocket cap
Outcomes based Contracting/value based arrangements
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
Advanced Safe Testing at Residence Telehealth Act of 2023
S. 2052, Protect Patient Access to Pharmacies Act
S. 476/HR. 5567, The Maintaining Investments in New Innovations (MINI) Act
H.R. 5539, ORPHAN Cures Act
Value-Based Purchasing (VBP) Rule
CBO modeling
H.R.2139/S.908: Medicare Drug Price Negotiation Act
H.R.2148/S.909: Prescription Drug Price Relief Act
H.R.5125: Strengthening Innovation in Medicare and Medicaid Act
S.127: Pharmacy Benefit Manager Transparency Act of 2023
S.142: Preserve Access to Affordable Generics and Biosimilars Act
S.150: Affordable Prescriptions for Patients Act of 2023
S.775: Increasing Transparency in Generic Drug Applications Act
S.1067: Ensuring Timely Access to Generics of 2023
COVID-19 Pricing-Related Provisions
National Coverage Determination
Alternative Payment Arrangements for Gene Therapies
Average Manufacturer Price Calculations
Medicaid Drug Rebate Program Rule (MDRP)
Medicare Part B Physician-Administered Products
National Coverage Determination
Patient Cost-Sharing and Smoothing
Protected Classes
Support of Patient Premiums and Cost-Sharing Obligations
Value-based Contracting and Communications
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), Executive Office of the President (EOP), Congressional Budget Office (CBO)
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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Stacie |
Aman |
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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
Base Erosion Anti-Abuse Tax (BEAT)
OECD Digital Tax
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))
Stopping Harmful Inversions and Ending Low-Tax Developments (SHIELD)
Tax Treaties
U.S. Corporate Tax
OECD Pillar Two
H.R.2673: American Innovation and R&D Competitiveness Act
S.866: American Innovation and Jobs Act
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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Courtney |
Lee-Ashley |
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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
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 policy issues
Quality of Medicines
Regulatory Cooperation
Supply chain and China Task Force policy issues
Tariffs
Trade Policy
US Swiss Trade Relations
US Switzerland Mutual Recognition Agreement on GMP
WTO IP Waiver
General Patent Reform
TRIPS 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, 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 LBR
16. Specific lobbying issues
Anti-Trust Reform
Non-competes
Federal Trade Commission's Non-Compete Clause Proposed Rule
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.
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 SCI
16. Specific lobbying issues
Artificial intelligence
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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Courtney |
Lee-Ashley |
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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 MAN
16. Specific lobbying issues
H.R. 555, Securing America's Vaccines for Emergencies Act of 2023
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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Courtney |
Lee-Ashley |
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Courtney |
Piron |
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Stacie |
Aman |
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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:
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) |
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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) |