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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 9600 Blackwell Road |
Address2 | Suite 210 |
City | Rockville |
State | MD |
Zip Code | 20850 |
Country | USA |
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5. Senate ID# 401105178-12
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6. House ID# 443210001
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TYPE OF REPORT | 8. Year | 2020 |
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. | ||||||||
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: Bruce Artim |
Date | 1/21/2021 12:20:51 AM |
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
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 issues related to certain proposals potentially affecting the reimbursement of gene therapies by the Medicare and Medicaid programs. This includes responding to the CMS regulatory proposal with respect to value based agreements and providing feedback on how this proposed rule affects legislation on VBAs pending in the Senate and being planned in the House. Activities included responding to Interim Final Rule known as the "Most Favored Nation" reimbursement system for certain Part B drugs.
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. In addition, working to achieve the reauthorization of the soon-expiring Pediatric Priority Review Voucher legislation.
Identify issues and allies with respect to the upcoming FDA User Fee reauthorization legislation (PDUFA VII) and the under development CURES 2.0 legislative initiative. Identified issues relevant to possible participation in NIH-FDA-FNIH Bespoke Gene Therapy Consortium.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), Health & Human Services - Dept of (HHS), Food & Drug Administration (FDA), Centers For Medicare and Medicaid Services (CMS)
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 |
BRUCE |
ARTIM |
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Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06) |
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
Data protection period for biologic medicines as affected by the proposed USMCA trade agreement. Planned trade related activities for new Administration and 117th Congress.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO)
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 |
BRUCE |
ARTIM |
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Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06) |
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
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. Followed up with the AAG for Antitrust and Antitrust Division staff on issues related to the anti-competitive effects of current U.S. case law and PTO administrative actions related to subject matter patentability.
Assisted Senior Vice President and Chief Patent Counsel in her participation on joint DOJ(ATR)-PTO Workshop on Competition Issues in the Life Sciences. Participated in meetings of the Section 101 Workgroup and Senate staff in preparation for discussion of legislative response to certain patent issues related to Section 101.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), Justice - Dept of (DOJ)
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 |
BRUCE |
ARTIM |
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Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06) |
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 IMM
16. Specific lobbying issues
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.
Analyzed and planned response to an Executive Order restricting immigration of highly-qualified non-U.S. citizen scientists and clinical trial patients.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, State - Dept of (DOS), Homeland Security - Dept of (DHS)
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 |
Bruce |
Artim |
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Senate Judiciary Committee Staff Member 1995-2006; (Chief Counsel and Staff Director 2003-04); Intellectual Property Subcommittee - Chief Counsel and Staff Director 2005-06) |
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:
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 | 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 |
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?
Lobbyist Name | Description of Offense(s) |