4th Quarter - Report

APOTEX CORP. for APOTEX CORP.

Firm
Client
Income
—
Expenses
$110,000
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. 27, the Preserve Access to Affordable Pharmaceuticals Act S. 1882, the FAIR Generics Act S. 296, HR 2245, The Preserving Access to Life Savings Medications Act Amending Section 505(j) of the Food, Drug, and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclams seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sub Pharmaceuticals Industries, Ltd. Prospective action on legislation establishing a generic drug user fee program Prospective action on legislation establishing a biosimilar user fee program Establishment of a federal track and trace system for pharmaceuticals Importation of prescription narcotic products into the United States The use of Risk Evaluation Mitigation Strategies (REMS) programs by brand drug companies to delay generic competition

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 Legislative Director, Congressman Frank Pallone

Contacted: SENATE; HOUSE OF REPRESENTATIVES; Federal Trade Commission (FTC)

Bills named: S. 1882 (112th), S. 27 (112th), S. 296 (112th), H.R. 2245 (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.