2nd Quarter - Report

APOTEX CORP. for APOTEX CORP.

Firm
Client
Income
—
Expenses
$260,000
Expense method
A: Lobbying Disclosure Act definitions

What was lobbied

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

Copyright/Patent/Trademark CPT

HR 9 - The Innovation Act, provisions in Section 9, Improvements and technical corrections to the Leahy-Smith America Invents Act; and S 1137 - The Patent Act, provisions in Section 7, Fees and other expenses, Section 14, Technical corrections to the Leahy-Smith American Invents Act and other improvements, including federal policy relating to the use of inter partes review challenges of pharmaceutical and biotechnology patents.

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: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 9 (114th)

Pharmacy PHA

HR 6 - The 21st Century Cures Act, provisions relating to the discovery, approval and manufacturing of pharmaceuticals; 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 2841 - The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S 1137 - The FAIR Generics Act, provisions relating to market blockages caused by "parked" 180 day exclusivity periods; Federal policy relating to International Nonproprietary Names for biosimilars; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, The Patient Protection and Affordable Care Act; and Federal policy relating to the Implementation of Public Law 112-144, The Food and Drug Administration Safety and Innovation Act, provisions in Title 3, Fees Relating to Generic Drugs.

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: HOUSE OF REPRESENTATIVES; SENATE

Bills named: H.R. 2841 (114th), H.R. 6 (114th)

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.