Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

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

H.R. Res. 117 - Fiscal 2013 Continuing Appropriations Resolution
S. 3295 - Fiscal Year 2013 Labor-HHS-Education Appropriations Act - provisions relating to Vaccine Section 317 program, Ryan
White CARE Act
H.R. 2693 - Budget Control Act of 2011 - sequestration implementation

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

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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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. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements
H.R. 3995 - Protect Consumer Access to Generic Drugs Act - provisions related to patent settlements
HR 3497 - MODERN Cures Act of 2011 - provisions related to data protection
S.27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements
H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics

H.R. 2182, S.1734 - Generating Antibiotic Incentives Now Act of 2011 - implementation of provisions related to antibiotics and incentives

S.373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics

S. 1882 - The Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements

No bill # assigned - International intellectual property issues

No bill # assigned - Biopharmaceutical innovation policy issues

No bill # assigned - Technical corrections to the America Invents Act

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

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

S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation
S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to
accelerated approval and other FDA matters

S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions"
H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases
H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters
H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages
H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program
PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions
H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies
H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security
H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security
H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine
H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment
H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages
H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety
H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform
S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform
H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts
S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety
No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies
S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates
H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance
S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing
H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine
S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine
No bill # assigned - Comparative effectiveness policy issues
No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

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

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

S.1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates
H.R.999 - Medicare Prescription Drug Savings and Choice Act of 2011 - provisions related to Medicare Part D
H.R.2190 - Medicare Drug Savings Act of 2011 - provisions related to Medicare Part D
H.R.452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB)
S.668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB)
S.1206 - Medicare Prescription Drug Savings Act of 2011 - provisions related to Medicare Part D
S.1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues
H.R.1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules
No bill # assigned - Dual eligibles coordination policy issues
No bill # assigned - Deficit reduction policy issues
No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking
No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking

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

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

S.3144 - "Temporary duty suspension for Preparations, such as tablets or chewing gum, intended to assist smokers to stop smoking (provided for in subheading 2106.90.99) "
H.R.942 - American Research and Competitiveness Act of 2011 - provisions relating to the research and development tax credit

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

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

No bill # assigned - Trans-Pacific Strategic Economic Partnership Agreement (TPP) - provisions related to intellectual property, market access and public health
H.R.6083 - Federal Agriculture Reform and Risk Management Act of 2012 - provisions related to WTO Brazil Cotton dispute

S.3240 - Agriculture Reform, Food and Jobs Act of 2012 - provisions related to WTO Brazil cotton dispute
No bill # assigned - Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations
No bill # assigned - EU/US trade liberalizing agreement
No bill # assigned - International market access and intellectual property issues

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Commerce - Dept of (DOC), State - Dept of (DOS), U.S. Trade Representative (USTR), Natl Security Council (NSC), White House Office

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

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

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization