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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1399 NEW YORK AVENUE NW |
Address2 | SUITE 300 |
| City | WASHINGTON |
State | DC |
Zip Code | 20005 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 15920-12
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6. House ID# 314640000
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| TYPE OF REPORT | 8. Year | 2015 |
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: Shannon C. Steward |
Date | 10/20/2015 2:51:40 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 HCR
16. Specific lobbying issues
: 340B, Patent Terms, Appropriations, Pandemic Preparedness, Tamiflu Stockpile; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectivness research, and FDA approval of follow-on biologics; Publaw 111-152, the Health Care and Education Reconcilation Act of 2010 - Implementation issues related Medicare and Medicaid payment for biotherapeutics, the 340B program, and the Medicare drug benefit; Meetings with Administration and congressional staff on coverage/payment issues related to cancer biotherapeutics, 340B program; Meetings with Administration staff concerning the President's precision medicine initiative; Issues related to the implementation of the follow-on biologiecs provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; 21st Century Cures Initiative (House Energy and Commerce Committee) and Innovation for Healthier Americans (Senate HELP Committee); issues concerning implementationof Patient Protection and Afforedable Care Act; Drug pricing under 340B program; : Implementation issues related to the Pharmaceutical Quality, Security and Accountabilty Act (P.L. 113-54) S. 2007, Preventing Regulatory Overreach to Enhance Care Technology Act of 2014, Cancer Patient Protection Act of 2013 pharma supply chain issues, issues related to the 340B Program;
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 |
David |
Burt |
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Director |
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Katherine |
Raab |
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Director |
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
intellectual property & process patent issues; MMM: Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B
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 |
David |
Burt |
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Director |
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Katherine |
Raab |
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Director |
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 TAX
16. Specific lobbying issues
Issues related to tax eform and tax extenders; corporate tax return; Issues relating to corporate tax reform including the R&D tax credit and taxation of foreign-owned corporations
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 |
David |
Burt |
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Director |
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
trade Promotion Authority; Issues relating to U.S. trade policy;
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 |
Katherine |
Raab |
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Director |
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 BUD
16. Specific lobbying issues
Issues related to FDA & HHS program funding, FY16 Labor Health and Human Services, and Education, and Related Agencies, and FY 16 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Bills.;
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 |
Anna |
Sagely-Griffin |
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Sr. Director |
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
Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics; HR 1470 and S.810, the SGR Repeal and Medicare Provider Payment Modernization Act of 2015 - Medicare physician payment reform, payment for Part B drugs; Pbulic Law 114-110, the Medicare Access and CHIP Reauthorization Act - Medicare physician payment reform and CHIP extension, payment for PART B drugs; Concerns regarding Medicare policies for Part B drugs. Issues related to the 340B Drug discount program; Implementation of P.L. 108-173, matters related to Medicare and Medicaid Coverage and Reimbursement; issues relating to Prescription Drug User Fee Act and ASP +6; issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin; issues related to coverage of Lucentis and Avastin; Issues related to 340B; Monitor implementation of Medicare pharmaceutical coverage and reimbursement, 340B, dual eligible demonstratins and Medicare Part B reimbursement for physicians and related provisions of The Affordable Care 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 |
Anna |
Sagely-Griffin |
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Sr. Director |
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David |
Burt |
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Director |
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 PHA
16. Specific lobbying issues
Public Law 111-148, the Patient Protection and Affordable Care Act 0 Implementation issues related to FDA approval of follow on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicare prescription drug benefit.; Public Law 111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid reimbursement, fees assessed on the pharmaceutical industry, design and structure of the Medicare prescription; General issues and congressional oversight related to FDA approval and CMS coverage decisions regarding Avastin and Lucentis.; Held discussions with Administration staff about 340B program requirements onparticipating pharmaceutical manufacturers., Held preliminary discussion with Administration staff on anti-viral drugs in the strategic national stockpile.
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 |
Katherine |
Raab |
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Director |
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David |
Burt |
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Director |
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Anna |
Sagely-Griffin |
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Sr. Director |
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:
| 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 |