In accordance with Article 38 of the Arbitration (Additional Facility) Rules and the Tribunal's order of July 24, 2012, claimants Apotex Holdings Inc. ("Apotex Holdings") and Apotex Inc. ("Apotex-Canada") (collectively, "Apotex") respectfully submit this Memorial in support oftheir claims against respondent United States of America.

INTRODUCTION

1. In August 2009, the United States Food & Drug Administration ("FDA") adopted a measure with crippling consequences for Apotex's business in the US. The measure, called an import alert, cut off the supply of 80% of the products sold by the US business. Apotex's US business was the sixth-largest seller of generic drugs in the US before the import alert was adopted. Two years later it was the 25th-largest.

2. The measure followed inspections of manufacturing practices at two Apotex facilities in Canada. The facilities produce finished drug products for the US market. FDA had repeatedly inspected both facilities before without incident. Six months after the 2008 inspection of the first facility, FDA issued a warning letter. The issuance of a warning letter signals a violation of regulatory significance that, if not promptly and adequately corrected, would lead to enforcement action. FDA had never before issued a warning letter to Apotex.

3. One month after the warning letter, FDA inspected the second facility. It adopted the import alert two weeks after the close of the inspection. It did so without issuing any warning letter, without notice, without providing Apotex an opportunity to present its position, without any suggestion that Apotex's products were unsafe or ineffective and without providing Apotex any opportunity to correct the issues raised by FDA before the measure was adopted.

4. FDA's actions shocked Apotex. While it believed that its processes were just as compliant with current good manufacturing practices as they had always been, Apotex could not afford to stay off the US market. It immediately hired outside consultants and embarked on an extensive and costly enhancement of its processes.