1. Pursuant to Article 21 of the UNCITRAL Arbitration Rules (1976), and in accordance with the Tribunal's Procedural Order No.1 of December 16,2010, the United States of America respectfully submits its Reply on Objections to Jurisdiction.

PRELIMINARY STATEMENT

2. Apotex Inc. (Apotex) is a Canadian manufacturer of generic drugs. The company has extensive facilities in Canada for developing, testing, producing, and labeling its drugs. By its own admission, "Apotex does not reside or have a place of business in the United States." Instead, Apotex exports its drugs from Canada to more than 115 countries around the world, including the United States, where they are sold by others.

3. Apotex alleges in this arbitration that it incurred substantial costs making abbreviated new drug applications (ANDAs) and complying with related regulatory standards in its testing, manufacturing, and labeling operations in Canada to allow export of its generic sertraline and pravastatin drugs to the United States. Apotex does not allege that the United States rejected its sertraline and pravastatin ANDAs. To the contrary, Apotex acknowledges that the U.S. government granted final approval of its ANDAs in 2006 and 2007, thereby allowing Apotex to export its drugs to the United States for sale by others. Nor does Apotex allege that it was the first applicant of "paragraph IV certifications" for generic sertraline or pravastatin drugs, making it eligible for 180 days of market exclusivity. Rather, Apotex challenged other companies' 180-day market exclusivity of generic sertraline and pravastatin drugs, and claims that Apotex's own generic drugs should have been available for sale in the United States just months earlier than was permitted. Apotex believes that this NAFTA investment tribunal is the appropriate forum to address that complaint.

4. This Tribunal lacks jnrisdiction to hear Apotex's claims, for three reasons. First, Apotex lacks standing to bring a claim under NAFTA Chapter Eleven. Apotex purports to be an "investor" that made "investments" in the territory ofthe United States, but it has produced no evidence to that effect, and its own pleadings affIrmatively belie its conc1usory statements.

5. Apotex asserts, without establishing, that an ANDA is an "investment" under Article 1139(g), because it constitutes "property" in the United States. Apotex's claims, however, are not related to its approved ANDAs. Apotex thus asserts that its tentatively-approved applications for revocable permission to export its generic products to the United States for sale by others constitute property in the United States. Whether tentatively or finally approved, however, ANDAs are not "property" for purposes of NAFTA Chapter Eleven.