1st Quarter - Report — REGENXBIO for REGENXBIO (2020)

Firm

REGENXBIO

Client

REGENXBIO

Income

—

Expenses

$110,000

Expense method

A: Lobbying Disclosure Act definitions

What was lobbied

4 issue areas, each in the filer's own words, with who lobbied on it and where.

Trade (domestic/foreign) TRD

Data protection period for biologic medicines as affected by the proposed USMCA trade agreement.

Lobbyist	Covered position, as disclosed
BRUCE ARTIM	Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: Patent & Trademark Office (PTO); Centers For Medicare and Medicaid Services (CMS); Justice, Dept of (DOJ); State, Dept of (DOS); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; Homeland Security, Dept of (DHS)

Copyright/Patent/Trademark CPT

Intellectual Property matters including patent law issues relevant to gene therapy including the issues of subject matter eligibility, the research use exemption, and march in rights. Other issues include legislation affecting so-called "patent thickening" and "product hopping" as they relate to patents protecting gene therapy. Met with the Assistant Attorney General for the Antitrust Division and other Antitrust Division officials with representatives of the Section 101 cross-coalition on patent reform issues.

Lobbyist	Covered position, as disclosed
BRUCE ARTIM	Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO); Health & Human Services, Dept of (HHS); SENATE; Justice, Dept of (DOJ); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; State, Dept of (DOS); Homeland Security, Dept of (DHS)

Health Issues HCR

Issues relating to the regulation and reimbursement for gene therapies including matters that affect FDA review and monitoring of these products as well as proposals related to how Medicare, Medicaid and other federal and private sector insurance programs pay for gene therapies including international price indexing, march in rights, and value based purchasing. Specific issues the reauthorization of the newborn screening act and the inclusion of value based agreement provisions for gene therapies in drug pricing reform proposals. Issues related to the drug pricing legislation moving in both the House and Senate with particular interest in provisions related to gene therapy including proposed amendments to the Medicaid Best Price rules. With respect to the pandemic relief legislation, lobbied on issued related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. Met with HHS Deputy Assistant Secretary for Legislation (Health) on matters pertaining to newborn screening legislation and the operation of the newborn screening advisory committee.

Lobbyist	Covered position, as disclosed
BRUCE ARTIM	Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: State, Dept of (DOS); Justice, Dept of (DOJ); Food & Drug Administration (FDA); SENATE; Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Homeland Security, Dept of (DHS); Centers For Medicare and Medicaid Services (CMS); Patent & Trademark Office (PTO)

Immigration IMM

Company was involved on CEOs "sign on" letter designed to encourage the Departments of State and Homeland Security (and Congress) not to exercise enforcement discretion in a manner that would result in deportation of foreign patients participating in U.S.-based clinical trials for rare and other diseases including patients remaining in the U.S. for necessary aftercare not available in their home countries.

Lobbyist	Covered position, as disclosed
BRUCE ARTIM	Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06)

Contacted: Food & Drug Administration (FDA); Patent & Trademark Office (PTO); Justice, Dept of (DOJ); State, Dept of (DOS); SENATE; Homeland Security, Dept of (DHS); Health & Human Services, Dept of (HHS); Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES

Shown as published by the Senate Office of Public Records and the House Clerk under the Lobbying Disclosure Act. The official filing is the record; open it for the full form.