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 PHA

16. Specific lobbying issues

Implementation of Food and Drug Administration Reauthorization Act (FDARA).
FDA Inspections.
Consent to FDA Approval.
Legislation to Grant Food and Drug Administration Needed Authority to Recall Unsafe Drug Products, Protect Consumers.
Generic Drug User Fee Amendments (GDUFA).
GDUFA III Negotiations.
Biosimilar User Fee Act (BsUFA).
Labeling of Generic Drugs and Biosimilars.
S.4492: Safe Drugs Act.
Country of Manufacture Labeling.
Modern Labeling.
Continuous Manufacturing.
Approval of Supplements to ANDA Changing Manufacturing Locations.
Drug Shortages.
Stockpile of Generic Drugs.
H.R.6516: Stockpiling for America's Future Endeavors Act of 2020.
Pass Through Payments for Biosimilars.
Cost Sharing for Biosimilars.
H.R.6179/S.4134: Increasing Access to Biosimilars Act of 2020.
H.R.4455: BIOSIM Act.
H.R.4597: Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019.
H.R.4629: Star Rating for Biosimilars Act.
Prescription Drug Costs.
Drug Pricing.
Executive Order 13947/13948: Lowering Drug Prices by Putting America First.
American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.
180-Day Exclusivity.
Forfeiture of 180-Day Exclusivity.
S.2543: Prescription Drug Pricing Reduction Act (PDPRA) of 2019.
H.R.938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019.
H.R.465/S.102: Prescription Drug Price Relief Act of 2019.
H.R.3: Lower Drug Costs Now Act of 2019.
S.1895: Lower Health Care Costs Act.
Reciprocal Marketing Authorization.
Risk Evaluation and Mitigation Strategies (REMS).
Pharmaceutical Exclusivity.
30-Month Stays.
S.659: Biologic Patent Transparency Act.
Biologics Price Competition and Innovation Act (BPCIA).
Orange Book.
Issues Related to COVID-19.
Implementation of Public Law No 116-136: Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Rubio Coronavirus Plan.
Buy American Proposals.
Buy American Executive Order.
S.3478: A bill to require a report to assess, evaluate, and address the dependence of the United States on critical drugs and devices sourced or manufactured outside of the United States.

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), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Justice - Dept of (DOJ), Natl Economic Council (NEC), Office of Management & Budget (OMB), 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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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 Part D Program and Generic Drugs.
Medicare Reimbursement for Biosimilars.
Medicaid Rebate Penalty.
Medicare Part D Low Income Subsidy (LIS) Program.
Medicare Part D Coverage Gap Discount Program.
H.R.4913: To amend title XVIII of the Social Security Act to require PDP sponsors of a prescription drug plan under part D of the Medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary, and for other purposes.
Medicare Shared Savings Program.
H.R.6179: Increasing Access to Biosimilars Act of 2020.
S.1895: Lower Health Care Costs Act.

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), Food & Drug Administration (FDA), Health & Human Services - Dept of (HHS), Office of Management & Budget (OMB), 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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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

Patent Settlements.
Patent Abuse.
BPCIA Patent Dance.
Inter Partes Review.
Government patent use law in regards to Section 1498 of statute codified at 28 USC Section 1498(a).
H.R.4850/S.659: Biologic Patent Transparency Act.
H.R.3666: STRONGER Patents Act of 2019.
S.4253: Second Look at Drug Patents Act of 2020.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Patent & Trademark Office (PTO)

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 BUD

16. Specific lobbying issues

FDA Funding.
S. Rept. 116-236: National Defense Authorization Act for Fiscal Year 2021.
Public Law 115-141: Consolidated Appropriations Act of 2018.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Food & Drug Administration (FDA)

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 TRD

16. Specific lobbying issues

General Trade Issues.
Pharmaceutical Exclusivity.
Quality Supply Chain.
Drug Supply Chain.
Pharmaceutical Supply Chain.
AAM Blueprint to Enhance the Security of the U.S. Supply Chain.
Carter Supply Chain Legislation.
S.4175: Pharmaceutical Supply Chain Defense and Enhancement Act.
United States-Mexico-Canada Agreement (USMCA).
U.S.-UK Trade Agreement.
U.S.-Kenya Trade Discussions.
U.S.-India Trade Discussions.
U.S.-European Trade Discussions.
U.S.-China Trade Discussions.
Secretary Azar Importation Plan.

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

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Health & Human Services - Dept of (HHS), Natl Economic Council (NEC), U.S. Trade Representative (USTR), 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

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes