3rd Quarter - Report

APOTEX CORP. for APOTEX CORP.

Firm
Client
Income
—
Expenses
$130,000
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

FDA proposed rule,Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; HR 5657, the Fair Acess for Safe and Timely Generics Act of 2014, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative; Federal policy relating to International Nonroprietary Names for Biosimilars; and, Implementation of Public Law 112-144 - The Food and Drug Administration Safety and Innovation Act, federal policy relating to provisions in Title 3 regarding generic drug user fees.

Foreign entity interest: Aposherm Inc., Apotex Holdings Inc., Sherfam 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: SENATE; HOUSE OF REPRESENTATIVES

Bills named: H.R. 5657 (113th)

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.