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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 | 2011 |
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 | |
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: Evan Morris, Vice President Federal Government Affairs |
Date | 07/15/2011 |
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
HCR: Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics, comparative effectiveness research, and FDA approval of follow on biologics. Public law111-152, the Health Care and Education Reconciliation Act of 2010 - Implementation issues related to Medicare and Medicaid payment for biotherapeutics, the 340B program, and Medicared drug benefit.; Prescription Drug User Fee Act (PDUFA);
Avastin - use in breast cancer treatment; Legislation on public health preparedness and response related to pandemic influenza. Influenza Pandemic preparedness federal, state and local levels. Legislation on screening, care and treatment for hepatitis.
Implementation of the Affordable Care Act of 2010; Advocate for approval of Avastin for late stage breast cancer treatment; HR 1/1473 - health care funding: FY12 Labor HHS Appropriations legislation Congress and Federal Agencies: U.S. House of Representatives; US Sentate; Implementation of HR 1; Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDFUA, stimulus. Issues relatiing to comparative effectiveness and CMS coverage of FDA approved therapies. Issues related to the PPS rule involving stroke guidelines. Implementation of the follow-on biolotics provisions in P.L. 111-148 - "Patient Protection and Affordable Care Act"; FDA approval and enforcement issues.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Evan |
Morris |
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Vice President of Government Affairs |
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Eli |
Kogan |
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Assoc. Director of Government Affairs |
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David |
Burt |
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Assoc. Director of Government Affairs |
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Darin |
Gardner |
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Director of Government Affairs |
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
FY11, FY12 Labor, HHS and Education Appropriation related to preparedness for pandemic influenza, HIV/AIDS programs, hepatitis screening, care and treatment, and access to breast cancer treatment. Implementation of H.R. 2346, S. 1054 FY09 Supplemental Appropriations related to preparedness for pandemic influenza.; issues related to pandemic preparedness and macular degeneration. FY11 appropriations process - including HR 1 and various Continuing Resolutions
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Evan |
Morris |
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VP Government Affairs |
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Katherine |
Martin |
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Director Government Affairs |
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
Medicare coverage and payment of Part B drugs and biologicals; Public Law 111-148, the Patient Protection and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Participated in discussions with House and Senate staff on Medicare coverage/payment issues related to cance biotherapeutics, including Avastin and Lucentis.;
Implementationof H.R. 1: Medicare Prescription Drug and Modernization Act of 2003; Issues relating to PDUFA, stimulus. Issues relating to comparative effectiveness and CMS coverage of FDA approved therapies. Issues related to the PPS rule involving stroke guidelines; Public Law 111-148, the Patient Protectiona and Affordable Care Act - Implementation issues related to Medicare and Medicaid reimbursement for biotherapeutics. Participated in discussions with House and Senate staff on Medicare coverage/payment issues related to cancer biotherapeutics, including Avastin and Lucentis; Monitor implentation of Medicine pharmaceutical coverage and reimbursement provisions of the Affordable Care Act; medicare issues; Implementation of P.L. 108-173, matters related to Medicare and Medicare Coverage and Reimbursement (Medicare Prescription Drug Act of 2003); Issues relating to prescription Drud User Fee Act: issues related to comparative effectiveness and follow-on biologics, issues related to FDA repeal of Avastin, Issues related to coverage of Lucentis and Avastin.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Evan |
Morris |
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VP Government Affairs |
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Darin |
Gardner |
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Director |
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David |
Burt |
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Assoc. 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 and Process Patent Issues; HR 1908, Patent Reform Act (all provisions); S.23 - Patent Reform Act; General Patent Reform Issues; Specfic issues lobbied (bill numbers): Patent reform legislation
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Darin |
Gardner |
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Director |
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Evan |
Morris |
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VP Government Affairs |
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Katherine |
Martin |
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Director |
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Eli |
Kogan |
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Assoc.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 MED
16. Specific lobbying issues
Public Law 111-148, the Patient Protection and Affordable Care Act of 2009 - Implementation issues related to the authorization for comparatice effective research and the Patient-Centered Outcomes Research Institute.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Evan |
Morris |
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VP Government Affairs |
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Darin |
Gardner |
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Director |
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Katherine |
Martin |
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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 FOO
16. Specific lobbying issues
Monitor and report on food safety and supply chain issues;
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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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Assoc. Director |
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Eli |
Burt |
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Assoc. Director |
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Evan |
Morris |
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VP 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 - Implementation issues related to FDA approval of follow-on biologics and length of data exclusivity period, 340B drug pricing program, structure of the Medicar 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.
drug benefit. General issue and congressional oversight related to FDA approval and CMS coverage decisions regarding. Avastin and Lucentis.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Evan |
Morris |
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VP Government Affairs |
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Katherine |
Martin |
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Director |
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Darin |
Gardner |
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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
Montior issues related to export rules and regulations, international patent issues, WTO matters, the Trans-Pacific, Partnership and other international issues impacting biotech and pharmaceuticals
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE
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 |
Evan |
Morris |
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VP Government Affairs |
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David |
Burt |
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Assoc. Director |
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Katherine |
Martin |
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Director |
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Darin |
Gardner |
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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 |