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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
| Address1 | 9605 Scranton Road |
Address2 | Suite 120 |
| City | San Diego |
State | CA |
Zip Code | 92121 |
Country | USA |
3. Principal place of business (if different than line 2)
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5. Senate ID# 7758-12
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6. House ID# 337930000
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| TYPE OF REPORT | 8. Year | 2021 |
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: Ms. Jayne McNicol |
Date | 4/20/2021 6:26:01 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 BUD
16. Specific lobbying issues
Labor/HHS/Ed Appropriations: NIH, antimicrobial resistance, biodefense/pandemic, CDC, science/math education, and strategic stockpile funding and preparation; Coronavirus funding and response.
FDA Appropriations; PTO Appropriations.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Julia |
McNerney |
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Danielle |
Mitchell |
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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
Support FDA user fee programs and review process consistency and predictability.
Support policy improvements to address antimicrobial resistance.
Oppose domestic manufacturing/procurement mandates for pharmaceutical products, APIs, & medical devices.
Support improvements to the Strategic National Stockpile for pandemic testing preparedness.
Support public education campaign on pandemic preparedness.
Support reauthorization of Rare Pediatric Disease Priority Review Voucher (RPD PRV) program.
Oppose drug importation proposals.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, 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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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
Address concerns with changes to Medicare Part B and Part D programs, and Hospital Outpatient Prospective Payment System.
Support reforms to enable Value Based Healthcare, including reforms to Anti-Kickback Statute & Stark Law.
Oppose International Pricing Index/reference pricing in Medicare, including Most-Favored Nation (MFN) EO, and H.R. 3.
Support ensuring patient access to/coverage of critical breakthrough products via Hospital Inpatient Prospective Payment System (IPPS) proposed and final rules, Hospital Outpatient Prospective Patient System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed and final rules, Medicare Coverage of Innovative Technology (MCIT) pathway proposed rule, final rule implementation, and legislation.
Oppose drug importation proposals.
Support temporary home administration of Medicare Part B infused and injectable medicines during the COVID-19 public health emergency.
Oppose changes to Notice of Benefit and Payment Parameters (NBPP) final rule regarding cost-sharing assistance.
Support separate reimbursement structure for novel antibiotics to incentivize Research & Development.
Support Medicare coverage of remote patient monitoring services.
Oppose prior authorization requirements in Medicare Advantage.
Support expanded access to telehealth.
Support value-based purchasing provision, but opposed line extensions and co-pay assistance provisions of CMS Medicaid VBP proposed rule.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), 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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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
Support Research & Development and NOL tax incentives.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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 MED
16. Specific lobbying issues
Support NIH research funding. Support implementation of 21st Century Cures Act.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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
Address concerns with provisions of patent litigation reform, including inter partes review.
Support STRONGER Patents Act.
Oppose "march-in" rights and "compulsory licensing" proposals.
Support transferable exclusivity extensions to incentivize novel antibiotic Research & Development.
Support efforts to strengthen Bayh-Dole provisions.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS), Natl Institute of Standards & Technology (NIST)
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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
Oppose proposals to reduce data exclusivity.
17. House(s) of Congress and Federal agencies Check if None
U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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 DEF
16. Specific lobbying issues
Oppose domestic manufacturing/procurement mandates in NDAA for pharmaceutical products, APIs, & medical devices.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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 SMB
16. Specific lobbying issues
Support changes to SBA's "affiliation rule."
Support changes to Main Street Lending Program's eligibility criteria.
Support Emerging Growth Companies (EGCs) Extension due to COVID-19.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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 DIS
16. Specific lobbying issues
Support exemptions from California's COVID-19 stay-at-home order for the life sciences community.
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES
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 |
Danielle |
Mitchell |
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Julia |
McNerney |
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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
| Address | 9605 Scranton Road, Suite 120 |
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| City | San Diego |
State | CA |
Zip Code | 92121 |
Country | USA |
21. Client new principal place of business (if different than line 20)
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State |
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Zip Code |
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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) |