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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 950 F Street, NW |
Address2 | Suite 300 |
City | WASHINGTON |
State | DC |
Zip Code | 20004 |
Country | USA |
3. Principal place of business (if different than line 2)
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Zip Code | |
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5. Senate ID# 31350-12
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6. House ID# 306540000
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TYPE OF REPORT | 8. Year | 2010 |
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: Paul J. Larsen, Deputy Compliance Officer & Assistant General Counsel |
Date | 04/20/2010 |
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
H.R. 573, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions
H.R. 1260, Patent Reform Act of 2009: reforms of the patent laws
H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics
H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics
H.R. 1706, Protecting Consumer Access to Generic Drugs Act of 2009: patent settlements
H.R. 3590, Patient Protection and Affordable Care Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, patent settlements, and authorized generics
H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics, and patent settlements
S. 369, Preserve Access to Affordable Generics Act: patent settlements
S. 501, To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs: authorized generic drug provisions
S. 515, Patent Reform Act of 2009: reforms of the patent laws
S. 610, Patent Reform Act of 2009: reforms of the patent laws
S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics, including provisions on data exclusivity and patent procedures for biologics
International intellectual property issues
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Patent & Trademark Office (PTO), U.S. Trade Representative (USTR), Commerce - Dept of (DOC), Federal Trade Commission (FTC)
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 |
Robert |
Filippone |
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Bryant |
Hall |
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Mimi |
Kneuer |
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David |
Korn |
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Thomas |
Moore |
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Brian |
Nagle |
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Richard |
Smith |
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Heather |
Strawn |
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Matt |
Sulkala |
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Billy |
Tauzin |
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Steve |
Tilton |
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Michael |
Woody |
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David |
Boyer |
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Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; |
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" |
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Asst. Comm'r for Leg.-FDA; Spec. Asst. for |
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" |
" |
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Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. |
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" |
" |
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Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. |
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" |
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Asst. Offc. of White Hse. Liaison-DOD; Conf. |
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" |
" |
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Asst. Offc. of Sec.-DOL |
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Lea |
Fisher |
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Leg. Asst.-Rep. Bob Etheridge |
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Anne |
Pritchett |
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Sen. Policy Analyst-White Hse. Drug Policy |
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" |
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Offc., Exec. Offc. of Pres. |
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Jennifer |
Swenson |
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Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts |
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 HCR
16. Specific lobbying issues
H.R. 444, 340B Program Improvement and Integrity Act: 340B program issues
H.R. 1298, Pharmaceutical Market Access and Drug Safety Act of 2009: importation
H.R. 1427, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics
H.R. 1548, Pathway for Biosimilars Act: regulatory approval pathway for follow-on biologics
H.R. 2502, Comparative Effectiveness Research Act of 2009: comparative effectiveness
H.R. 2824, Doctor-Patient Relationship and Research Protection Act: comparative effectiveness
H.R. 3590, Patient Protection and Affordable Care Act: comparative effectiveness, 340B program issues, regulatory approval for follow-on biologics, drug labeling, access to clinical trials, importation, health reform fee and health reform issues generally
H.R. 3962, Affordable Health Care for America Act: regulatory approval for follow-on biologics, 340B program issues, comparative effectiveness, importation, and health reform issues generally
H.R. 4489, To amend chapter 89 of title 5, United States Code, to ensure program integrity, transparency, and cost savings in the pricing and contracting of prescription drug benefits under the Federal Employees Health Benefits Program: PBM transparency
H.R. 4872, Health Care and Education Reconciliation Act of 2010: 340B program issues, health reform fee and other heath care reform issues
S. 525, Pharmaceutical Market Access and Drug Safety Act of 2009: importation
S. 726, Promoting Innovation and Access to Life-Saving Medicine Act: regulatory approval pathway for follow-on biologics
S. 914, Cures Acceleration Network and National Institutes of Health Reauthorization of 2009: basic research and development
S. 1142, Informed Health Care Decision Making Act: drug labeling
S. 1213, Patient-Centered Outcomes Research Act of 2009: comparative effectiveness
S. 1232, Pharmaceutical Market Access and Drug Safety Act of 2009: importation
S. 1679, Affordable Health Choices Act: health reform, regulatory approval pathway for follow-on biologics, 340B program issues, importation
Health and environment issues
User fee issues
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, White House Office, Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Congressional Budget Office (CBO), Agency for Health Care Policy & Research, 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 |
Maya |
Bermingham |
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Randy |
Burkholder |
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Andrea |
Douglas |
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Robert |
Filippone |
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Bryant |
Hall |
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Valerie |
Jewett |
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Ann |
Kaplan |
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Mimi |
Kneuer |
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David |
Korn |
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Hallie |
Maranchick |
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Kendra |
Martello |
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Thomas |
Moore |
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Brian |
Nagle |
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Byron |
Patterson |
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Lori |
Reilly |
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Richard |
Smith |
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Heather |
Strawn |
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Matt |
Sulkala |
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Billy |
Tauzin |
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Steve |
Tilton |
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Jennifer |
Van Meter |
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Michael |
Woody |
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David |
Boyer |
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Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; |
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" |
" |
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Asst. Comm'r for Leg.-FDA; Spec. Asst. for |
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" |
" |
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Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. |
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" |
" |
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Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. |
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" |
" |
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Asst. Offc. of White Hse. Liaison-DOD; Conf. |
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" |
" |
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Asst. Offc. of Sec.-DOL |
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Jennifer |
Bryant |
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Daniel |
Durham |
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Act. Dep. Asst. Sec. Health Pol., Dep. to Dep. |
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" |
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Asst. Sec. Health Pol., Sen. Advr. Health Pol.- |
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HHS; Act. Assoc. Comm'r & Dep. Assoc. |
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" |
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Comm'r Ret. Pol.-SSA, Pol. Analyst & Bud. |
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Exam.-OMB |
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Lea |
Fisher |
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Leg. Asst.-Rep. Bob Etheridge |
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Gregory |
Gierer |
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LA, LC-Sen. Christopher Dodd; Staff Asst.-Rep. |
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" |
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Rosa DeLauro |
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Anne |
Pritchett |
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Sen. Policy Analyst-White Hse. Drug Policy |
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" |
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Offc., Exec. Offc. of the Pres. |
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Jennifer |
Swenson |
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Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts |
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
H.R. 3590, Patient Protection and Affordable Care Act: Part D coverage gap discounts, Part D rebates, Part D issues generally, Medicare payment issues, Medicaid rebate issues, transparency issues, comparative effectiveness, health reform fee and health reform issues generally
H.R. 3962, Affordable Health Care for America Act: Part D coverage gap, Part D rebates, Part D issues generally, Medicaid rebate issues, transparency issues, comparative effectiveness, and health reform issues generally
H.R. 4752, Medicare Prescription Drug Price Negotiation Act of 2010: non-interference provisions
H.R. 4872, Health Care and Education Reconciliation Act of 2010: Part D coverage gap discounts, Part D issues generally, Medicaid rebate issues, health reform fee and health reform issues generally
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Centers For Medicare and Medicaid Services (CMS), Agency for Health Care Policy & Research, Health & Human Services - Dept of (HHS), Congressional Budget Office (CBO), White House Office, 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 |
Maya |
Bermingham |
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Jennifer |
Bryant |
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Randy |
Burkholder |
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Andrea |
Douglas |
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Bryant |
Hall |
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Ann |
Kaplan |
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Mimi |
Kneuer |
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Hallie |
Maranchick |
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Thomas |
Moore |
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Brian |
Nagle |
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Lori |
Reilly |
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Richard |
Smith |
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Heather |
Strawn |
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Matt |
Sulkala |
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Billy |
Tauzin |
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Steve |
Tilton |
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Jennifer |
Van Meter |
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|
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David |
Boyer |
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Spec. Asst. to Pres. for Leg. Affrs.-White Hse.; |
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" |
" |
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Asst. Comm'r for Leg.-FDA; Spec. Asst. for |
|
" |
" |
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Oversight-HHS; Spec. Asst. to Sec.-HHS; Spec. |
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" |
" |
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Asst. Offc. of Asst. Sec. for Leg.-HHS; Spec. |
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" |
" |
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Asst. Offc. of White Hse. Liaison-DOD; Conf. |
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" |
" |
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Asst. Offc. of Sec.-DOL |
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Daniel |
Durham |
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Act. Dep. Asst. Sec. Health Pol., Dep. to Dep. |
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" |
" |
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Asst. Sec. Health Pol., Sen. Advr. Health Pol.- |
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" |
" |
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HHS; Act. Assoc. Comm'r. & Dep. Assoc. |
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" |
" |
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Comm'r Ret. Pol.-SSA; Pol. Analyst & Bud. |
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" |
" |
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Exam.-OMB |
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Lea |
Fisher |
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Leg. Asst.-Rep. Bob Etheridge |
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Gregory |
Gierer |
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LA, LC-Sen. Christopher Dodd; Staff Asst.-Rep. |
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" |
" |
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Rosa DeLauro |
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Jennifer |
Swenson |
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Staff Asst., LC, LA, Dep. LD-Sen. Pat Roberts |
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
H.R. 3012, Trade Reform, Accountability, Development, and Employment Act of 2009 (TRADE Act of 2009): trade agreements
Korea Free Trade Agreement: intellectual property, market access and public health
Trans-Pacific Strategic Economic Partnership Agreement (TPP): intellectual property issues
Special 301 submission: intellectual property protection and enforcement
Preference Program Reform: market access issues, intellectual property protection and enforcement
International market access and intellectual property issues
Trade enforcement issues
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Executive Office of the President (EOP), U.S. Trade Representative (USTR), Commerce - Dept of (DOC), State - Dept of (DOS)
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 |
Lea |
Fisher |
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Leg. Asst.-Rep. Bob Etheridge |
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Robert |
Filippone |
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Matt |
Sulkala |
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Valerie |
Jewett |
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Anne |
Pritchett |
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Sen. Policy Analyst-White Hse. Drug Policy |
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" |
" |
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Offc., Exec. Offc. of President |
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: http://www.phrma.org/about_phrma/member_company_list/members
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 | 3 | 5 |
2 | 4 | 6 |
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 | 5 | 9 |
2 | 6 | 10 |
3 | 7 | 11 |
4 | 8 | 12 |