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

PRELIMINARY STATEMENT

1. NAFT A Chapter Eleven accords protections to "investors" from one NAFT A Party to the extent they have made or have sought to make "investments" located in the territory of another NAFTA Party. According to the Claimant, Apotex Inc. ("Apotex") is a corporation registered in the province of Ontario, Canada that has made such "investments," specifically through expenditures "in preparing ANDAs for filing in the United States" and iii "formulating,  developing, and manufacturing approved generic pharmaceutical products for sale in  the United States."

2. As discussed below, Apotex has failed to establish that it meets the basic elements of a Chapter Eleven claim-that it is an "investor" that has made or is seeking to make an "investment" in the United States. Any company that intends to have a generic drug product marketed in the United States must file an abbreviated new drug application ("ANDA"), which is an application for approval to sell generic pharmaceutical products in the United States. That regulatory requirement applies to any company whose products will be sold in the United States, regardless of whether the company is  investing in the United States or merely exporting goods to the United States. Apotex's own ANDA filings and submissions in this arbitration make clear that the company is an exporter that intended to  export its sertraline hydrochloride ("sertraline") and pravastatin sodium ("pravastatin") products to the United States, where those products would be sold by "others." Apotex makes no attempt to articulate how expenditures made in preparing an application for regulatory approval to have its products sold by distributors in the United States constitute an "investment" as defined under NAFTA Article 1139. In  addition, the formulation, development, and manufacture of those products occur outside the United States, and thus do not constitute an investment within the United States. Given Apotex's failure to support its allegation that the company made an "investment" in the United States, Apotex cannot be considered an "investor" under Article 1116. As such, Apotex's claims should be dismissed in their entirety.

3. In  addition, many of Apotex's claims are time-barred. NAFTA Chapter Eleven sets out a clear limitations period, which requires a notice of arbitration to be submitted within three years of the date on which the claimant first acquired knowledge of an alleged breach and of loss or damage. In its sertraHne and pravastatin claims, Apotex alleges breach and loss occurring outside the applicable three-year limitations period. Those occurrences of breach and loss, according to Apotex, arose from a federal court decision that was issued prior to December II, 2005 (for the sertraline claim) and certain U.S. Food and Drug Administration ("FDA") and federal court decisions that were issued prior to June 5, 2006 (for the pravastatin claim). Those claims are time-barred and should be dismissed.