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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 9804 Medical Center Dr. |
Address2 | Fourth Floor |
| City | Rockville |
State | MD |
Zip Code | 20850 |
Country | USA |
3. Principal place of business (if different than line 2)
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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 | 2023 |
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: Bruce Artim |
Date | 7/19/2023 3:41:53 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 HCR
16. Specific lobbying issues
Issues affecting biotechnology firms engaged in developing gene therapies, including:
the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program;
Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices;
Changes to the Orphan Drug Act; and,
Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.)
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
Covid vaccine and potential waiver of IP rights for covid therapeutics and diagnostics.
Strong patent and regulatory data protection for biopharmaceuticals in trade agreements.
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
Proposals to change subject matter patent eligibility under Section 101 and other proposals to amend the patent code as they relate to gene therapies and other biopharmaceutical innovations, including: S.2140, the Patent Eligibility Restoration Act and the Coons/Tillis-Buck/Ross PREVAIL Act related to PTO PTAB reform.
Assertions of March In Rights under the Bayh-Dole Act or under Section 1498 against biopharmaceutical products
The ongoing PTO-FDA collaboration on drug pricing
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), Food & Drug Administration (FDA)
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
Proposals to change immigration laws and policies that affect the ability of biopharmaceutical firms to recruit and retain non-U.S. citizens.
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
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
Proposals to allow the direct expensing of R&D expenditures, including S.866, the American Innovation and Jobs Act (S.866) and the Build It in America Act (H.R. 3938).
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
| 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) |