2nd Quarter - Report

APOTEX CORP. for APOTEX CORP.

Firm
Client
Income
—
Expenses
$170,000
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

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

Pharmacy PHA

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

Foreign entity interest: 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.

LobbyistCovered position, as disclosed
STEVEN GIULI —

Contacted: Federal Trade Commission (FTC); HOUSE OF REPRESENTATIVES; Congressional Budget Office (CBO); SENATE

Bills named: H.R. 4332 (112th), S. 2516 (112th), S. 3187 (112th), S. 1882 (112th), S. 27 (112th), H.R. 5651 (112th)

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.