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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 1455 Pennsylvania Ave., NW |
Address2 | Suite 500 |
City | Washington |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
City | Cambridge |
State | MA |
Zip Code | 02141 |
Country | USA |
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5. Senate ID# 16054-12
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6. House ID# 302570000
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TYPE OF REPORT | 8. Year | 2017 |
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: Sara Froelich |
Date | 4/21/2017 12:47:43 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 MMM
16. Specific lobbying issues
Medicare Part D coverage and patient access policies
ESRD bundling and drug reimbursement issues
HCPCS coding and reimbursement decisions
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152)
Least Costly Alternative (LCA) policy
Changes regarding Medicare Part B and Average Sales Price
Medicare secondary payor for ESRD services
Extension of rebates on Medicare Part D drugs
Performance measures for bone and mineral metabolism for ESRD program
Implementation of American Taxpayer Relief Act of 2012
Access of ESRD patients to Medicare Advantage plans
Chronic kidney care improvement
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Centers For Medicare and Medicaid Services (CMS)
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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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 PHA
16. Specific lobbying issues
Implementation of Food and Drug Safety and Innovation Act (FDASIA)
Issues and policies related to biosimilars exclusivity period
Biosimilars FDA guidance
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconciliation Act (P.L. 111-152)
Issues and policies related to FDA oversight and management
Issues and policies related to expanded access programs
Issues and policies related to patient involvement with FDA decision making
S. 204, Trickett Wendler Right to Try Act of 2017
H.R. 878, Right to Try Act of 2017
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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of health Care and Education Reconciliation Act (P.L. 111-152)
Excise tax for drugs and biologics
Issues and policies related to Orphan Drug Tax Credit
Implementation of American Taxpayer Relief Act of 2012
Issues and policies related to tax reform, including border adjustable tax
Corporate tax inversion
Legislation pertaining to the applicability of the ACA tax carve out for non-orphan designated drugs
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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Implementation of Patient Protection & Affordable Health Care Act (P.L. 111-148) and Implementation of Health Care and Education Reconcilation Act (P.L. 111-152)
340B issues and legislative reform proposals
Issues related to importation of prescription drugs
Health technology assessment of orphan and specialty drugs
Implementation of the FDA Safety and Innovation Act (FDASIA) (P.L. 112-144)
H.R. 1628, American Health Care Act of 2017
H.R. 1231, RACE for Children Act
S. 456, RACE for Children Act
Preserve Access to Affordable Generics Act
H.R. 878, Right To Try Act of 2017
S. 204, Trickett Wendler Right To Try Act of 2017
Creating and restoring Equal Access to Equivalent Samples Act
H.R. 314, Health Care Choice Act of 2017
S. 191, Patient Freedom Act of 2017
H.R. 184, Protect Medical Innovation Act of 2017
Regulation of innovative biologic products for neurodegenerative diseases
Issues and policies related to implementation of Orphan Drug Act and orphan drug development
Implementation of newborn screening programs
Issues and policies related to biosimilars exclusivity period, including FDA guidance
Issues and polices related to FDA oversight and management, including workforce authorities modernization
Issues and policies related to expanded access programs
Legislation pertaining to FDA priority review vouchers,generally
Issues related to the value of prescription medicines, including affordability
Drug shortage issues
Issues related to health care transparency
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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Funding for FDA and NIH
Issues and policies related to FY 2017 and FY 2018 appropriations and all applicable amendments
Issues associated with budget reconciliation processes
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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Patent settlement legislation
Preserve Access to Affordable Generics Act
Creating and Restoring Equal Access to Equivalent Samples 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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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
Trade legislation and other trade authority
Protection and promotion of 12 years exclusivity for biologics
Protection and promotion of Orphan Drug Act market exclusivity
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 |
Sara |
Froelich |
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Melissa |
Bartlett |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
As the ultimate parent of Genzyme Corporation, Sanofi SA, identified on Form LD-1, has an interest in the issues lobbied.
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 |