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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 701 PENNSYLVANIA AVENUE, NW, #725 |
Address2 |
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| 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 | 2016 |
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: Daniel Casserly |
Date | 4/20/2016 9:50:34 AM |
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
S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015
S.481 - Improving Regulatory Transparency for New Medical Therapies Act
H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015
H.R.6 - 21st Century Cures Act
Gene Therapy
Personalized Medicine
Section 9008 of Patient Protection and Affordable Care Act
FSA/HSA - Support reinstating coverage of OTC products
HR351/S351 - Medicine Decisions Act of 2011 (IPAB)
340B Drug Discount Program
Dual Eligibles Program
DQSA Implementation (Track & Trace)
Certified Importer Program
MDUFA (Medical Device User Fee Act) Implementation
Drug Importation
Reimbursement for medical devices
GMP related to manufacturing sites
Biosimilars
PDUFA
Low-income Subsidy in Part D
REMS
FCLCA
Value of Medicines
Drug Cost/Pricing
Biosimilars Reimbursement
Generic Drugs
Medicaid
FDA Regulations of Lab Developed Tests (LDT)
Reimbursement for LDTs
2015 Omnibus Appropriations bill
Part B Demo
Regrow Act
IPAB
Generic Drug Labeling
H.R.4784 Lower Drug Costs through Competition Act
S.2615 Increasing Competition in Pharmaceuticals Act
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)
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 |
Daniel |
Casserly |
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Shawn |
O'Neail |
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Jason |
Van Pelt |
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Leo |
Farber |
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Sarah |
Haller |
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Wendy |
Sussman |
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Candie |
Phipps |
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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
Free Trade Agreements:
- Intellectual Property and Transparency Provisions - Free Trade Agreements
Access to Medicines Issues
Global Health Issues
India, China and Canada IP and market Access Issues
Trans-Pacific Partnership FTA
Sub-standards Medicines
Quality of Medicines
Global Intellectual Property Issues Including:
- Trade Promotion Authority
- Trans-pacific Partnership
- Trans Atlantic Trade and Investment Partnership
International Market Access and Intellectual Property Issues
Biopharmaceutical Innovation Policies
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Commerce - Dept of (DOC), State - Dept of (DOS), U.S. Agency for International Development (USAID)
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 |
Sarah |
Haller |
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Leo |
Farber |
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Jason |
Van Pelt |
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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 BUD
16. Specific lobbying issues
FDA Appropriations funding for Generic Drugs
Certified Importer Program (CIP)
FY 2016 Labor HHS Appropriations Bill
Reconciliation
Gx Drug Labeling
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 |
Daniel |
Casserly |
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Shawn |
O'Neail |
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Jason |
Van Pelt |
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Leo |
Farber |
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Wendy |
Sussman |
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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
Biosimilars
Medicare Part D
Drug Pricing
Part B
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 |
Daniel |
Casserly |
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Shawn |
O'Neail |
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Jason |
Van Pelt |
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Leo |
Farber |
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Wendy |
Sussman |
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Candie |
Phipps |
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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
ACA Pharmaceutical Industry Fee Exclusions
R&D Tax Credit
Anti-Inversion Tax
H.R.3618 - Orphan Drug Fairness Act
S.1906 - Orphan Drug Fairness Act
Medical Device Tax Repeal & Suspension
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 |
Daniel |
Casserly |
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Shawn |
O'Neail |
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Jason |
Van Pelt |
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Leo |
Farber |
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Candie |
Phipps |
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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
HR3116 MODDERN Cures Act of 2013
S.632 STRONG Patents Act of 2015
HR.9 Innovation Act
S.1137 PATENT Act
Data Exclusivity
Trade Secrets
Intellectual Property
Biopharmaceutical Innovation Policy Issues
Biologics Data Protection Issues
Patient Litigation Reform and Issues Related to Post Grant Proceedings at PTO
S.1890 Defend Trade Secrets Act of 2016
H.R.3326 Defend Trade Secrets Act of 2015
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 |
Daniel |
Casserly |
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Shawn |
O'Neail |
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Jason |
Van Pelt |
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Leo |
Farber |
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Candie |
Phipps |
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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) |
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 |