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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 1050 K STREET, NW, #800 |
Address2 |
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| City | WASHINGTON |
State | DC |
Zip Code | 20001 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 16293-12
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6. House ID# 314610000
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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: William J. Schuyler |
Date | 10/19/2015 12:33:41 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 BUD
16. Specific lobbying issues
Sen. Con. Res 11 amendments relevant to the biopharmaceutical industry including Medicare Part D
H. Con. Res. 27 amendments relevant to the biopharmaceutical industry including Medicare Part D
H.R 1078 Food and Drug Administration Safety Over Sequestration Act of 2015 - Provisions related to exemption of certain user fees from sequestrationProvisions related to drug reimbursement, Part D, and biopharmaceutical research
No bill # assigned2016 Agriculture Appropriations Bill Provisions related to compounding and e-labeling
No bill # assignedThe Presidents FY 2016 Budget Provisions related to prescription drug reimbursement and data exclusivity.
No bill # assignedFY 2016 Budget Resolution/Budget Control ActProvisions related to spending caps
No bill # assignedBudget Control Act Provisions related to drug reimbursement, Part D, and biopharmaceutical research
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Julie |
Venners Christensen |
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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
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement
S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements
S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration
S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion
S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO)
S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity
S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements
S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements
S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data
S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity
H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO
H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval
H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration
H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity
H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity
H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters
Issues related to abuse deterrent exclusivity incentives
Patent litigation reform issues and issues related to post-grant proceedings at the PTO
Patent settlement policy issues
Biopharmaceutical innovation and patent policy issues
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Julie |
Venners Christensen |
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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. 2629 Antibiotic Development to Advance Patient Treatment Act Provisions related to the approval of certain drugs for use in a limited population of patients
H.R. 1537H.R. 1537: Advancing Hope Act of 2015 Provisions related to making permanent pediatric rare disease voucher program
H.R. 909(CURE) Act Provisions related to expanded access
H.R. 880 American Research and Competitiveness At of 2015 Provisions to make permanent the research and development (R&D) tax credit
H.R. 786 Vaccine Access, Certainty, and Innovation Act of 2015 Provisions related to vaccine development
H.R. 6 21st Century Cures Act Provisions related to biopharmaceutical discovery, development, delivery and transparency
S. 1128 Preserving Access to Orphan Drugs Act Provisions related to orphan drug tax (113th Congress)
H.R. 1547 Family Health Care Flexibility ActProvisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts
No bill # assigned Antibiotic Development to Advance Patient Treatment ActProvisions related to antibiotics and drug approvalAllHouse/Senate
S. 836Family Health Care Flexibility Actprovisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts
S. 122Safe and Affordable Drugs from Canada Actprovisions related to drug importation
S. 185PATH Act provisions related to antibiotics and drug approval
S. 320Medical Innovation Act of 2015provisions related to NIH funding and covered manufacturer supplemental fees
No bill # assignedImplementation issues relating to the Patient Protection and Affordable Care Act (PPACA) (Public Law 111-148), including Standards Related to Essential Health Benefits, Actuarial Value, and Accreditation rulemaking
No bill # assigned21st Century Cures Initiative and related policy issues
No bill # assignedFDA special medical useissues related to limited population antibacterial drug approval pathway
No bill # assignedFDA accelerated approval policy issues
No bill # assignedComparative effectiveness policy issues
No bill # assignedBiopharmaceutical innovation policy issues
No bill # assignedPharmaceutical supply chain security issues
No bill # assigned340B policy issue
No bill # assignedImplementation issues relating to the Physician Payment Sunshine Act
No bill # assignedSupport for COPD national action plan
No bill # assignedFDA proposed rule regarding generic drug labeling under the 1984 Hatch-Waxman amendments to the FDCA
No bill # assignedFDA proposed rule regarding electronic distribution of Content of Labeling for Human Prescription Drug and Biological product
HR. 3299 - the Strengthening Public Health Emergency Response Act of 20
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Julie |
Venners Christensen |
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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. 2581 Preservation of Access for Seniors in Medicare Advantage Act of 2015 Provisions related to changes to the Medicare Advantage Program
H.R. 2570 Strengthening Medicare Advantage through Innovation and Transparency for Seniors of 2015Provisions related to changes to the Medicare Advantage Program
H.R. 1190 H.R. 1190: Protecting Seniors Access to Medicare Act of 2015 Provisions related to IPAB repeal
S. 1369Value-Based Insurance Design Seniors Copayment Reduction Act of 2015 Provisions related to changes to the Medicare Advantage Program
S. 1083 Medicare Drug Savings Act of 2015
S. 141 Protecting Seniors' Access to Medicare Act of 2015 Provisions related to Independent Payment Advisory Board (IPAB) repeal
S. 31 Medicare Prescription Drug Price Negotiation Act of 2015 Provisions related to Secretary negotiation authority in Part D program
H.R. 1190 Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board
H.R. 1470 SGR Repeal and Medicare Provider Payment Modernization Act of 2015Provisions related to SGR reform
H.R. 4187 Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM)
S. 31Medicare Prescription Drug Price Negotiation Act of 2013provisions related to Part D issues
S. 141Protecting Seniors' Access to Medicare Act of 2013provisions related to the Independent Payment Advisory Board
S. 648Medicare Formulary Improvement Actprovisions related to Medicare Part D
No bill # assignedProposals to increase co-payments for Part D beneficiaries receiving the low-income subsidy
No bill # assignedIssues related to better use of medicines and comprehensive medication management
No bill # assignedVaccine access and coverage issues
HR. 512 - the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014
S. 2055 - the Medical Countermeasure Innovation 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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Julie |
Venners Christensen |
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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
H.R. 880American Research and Competitiveness Act of 2015A bill to modify and make permanent the research and development (R&D) tax credit
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Julie |
Venners Christensen |
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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 TAR
16. Specific lobbying issues
None
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 |
Joseph |
McGowan |
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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. 1314 Trade Act of 2015 Provisions related to Trade Promotion Authority
No bill # assignedTrans-Pacific Strategic Economic Partnership Agreement (TPP)provisions related to intellectual property, market access and public health issues
No bill # assignedTransatlantic Trade and Investment Partnership (TTIP)provisions related to market access intellectual property, regulatory harmonization and other issues
No bill # assignedInternational market access and intellectual property issues
No bill # assignedCanada IP and market access issues
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), White House Office
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 |
William |
Schuyler |
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Kimberly |
Williams |
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Joseph |
McGowan |
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Shira |
Kilcoyne |
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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:
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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 |