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LOBBYING REPORT |
Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page
2. Address
Address1 | 2400 N. COMMERCE PARKWAY |
Address2 | |
City | WESTON |
State | FL |
Zip Code | 33326 |
Country | USA |
3. Principal place of business (if different than line 2)
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Zip Code | |
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5. Senate ID# 310973-12
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6. House ID# 386230000
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TYPE OF REPORT | 8. Year | 2012 |
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 | |
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: Steve Giuli, Director of Government Affairs & Industry Relations |
Date | 07/13/2012 |
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
S. 1882, The Fair and Immediate Release of Generics Act
S. 27, the Preserve Access to Affordable Pharmaceuticals Act
HR 4332, the Generic Drug Application Review Fairness Act
Amending Section 505(j) of the Food, Drug and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect patent information submitted to FDA's Orange Book by patent owners of New Drug Applications
Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmacuetical Industries Ltd.
S. 2516, the Food and Drug Innovation and Safety Act:
Title VIII, Generating Antibiotic Incentives,
Title XI, Other Provisions, Section 1131, Drug Development and Testing
HR 5651. the Food and Drug Administration Reform Act:
Title VIII, Drug Regulatory Improvements, Subtitle F, Miscellaneous, Section 862, Extension of period for first applicant to
obtain tentative approval without forfeiting 180-day exclusivity period, Section 863, Final agency action relating to petitions
and civil actions
S. 3187.PCS/.ES, the Food and Drug Administration Safety and Innovation Act:
Title XI, Other Provisions, Subtitle C, Miscellaneous Provisions, Section 1131, Drug Development and Testing
S AMDT 2111 to S. 3187, concerning pharmaceutical market blockages caused by parked 180 day exclusivity periods
S. 3187.EAH, the Food and Drug Administration Safety and Innovation Act:
Title XI, Other Provisions, Subtitle C, Miscellaneous Provisiosn, Section 1133, Extension of period for first applicant to
obtain tentative approval without forfeiting 180 day exclusivity period, Section 1135, Final agency action related to petitions
and civil actions
Establishment of a federal track and trace system for pharmaceuticals
17. House(s) of Congress and Federal agencies Check if None
U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Congressional Budget Office (CBO), Federal Trade Commission (FTC)
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 |
Steve |
Giuli |
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19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None
Aposherm Inc., Apotex Holdings Inc., Shermfam Inc., and Shermco Inc., the parent companies of Apotex Corp. identified on LD-1, have direct or indirect interests in companies that develop, manufacture, and/or sell generic drugs and therefore are interested in the issues identified in this report.
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 |