1. In accordance with Procedural Order No. 1, entered on December 16, 2010, Claimant Apotex Inc. hereby respectfully submits its Counter-Memorial On Respondent's Objections To Jurisdiction.

I. INTRODUCTION.

2. Apotex's arbitration claims under Chapter Eleven of NAFTA arise directly from Respondent's violations of Apotex's reasonable and legitimate expectations regarding its investments in its Abbreviated New Drug Applications ("ANDAs") for Sertraline Hydrochloride Tablets and Pravastatin Sodium Tablets, and Respondent's breach of its obligations under NAFTA. More specifically, with respect to each of Apotex's two arbitration claims (i.e., the "Sertraline Claim"—subject of Apotex' s Notice of Arbitration dated December 10, 2008, and the "Pravastatin Clahn"—subject of Apotex's Notice of Arbitration dated June 4, 2009), the actions of Respondent United States of America ("Respondent" or "United States") violated at least its obligation to: (1) accord to Apotex treatment no less favorable than it accords its own investors in like circumstances under NAFTA Article 1102; (2) accord to Apotex treatment in accordance with international law, including fair and equitable treatment, under NAFTA Article 1105; and (3) refrain from directly or indirectly nationalizing or expropriating Apotex's investment under NAFTA Article 1110.

3. Prior to resolving Apotex's arbitration claims on their merits, Respondent urges this Tribunal to dismiss Apotex's claims, alleging that Apotex's claims somehow fall outside the scope of NAFTA. In particular, Respondent argues, without foundation, that somehow Apotex is not an "investor" that made or sought to make an "investment" under NAFTA; that a portion of Apotex's claims are somehow untimely; and that Apotex somehow failed to satisfy the finality requirement for its Pravastatin arbitration claim. For the reasons stated herein, each of Respondent's purported jurisdictional challenges fail and should (and indeed must) be rejected in their entirety.

4. To begin, under the plain terms of NAFTA, Apotex is an "investor" that made "investments . . . in the territory of the Party," thus bestowing this Tribunal with the necessary jurisdiction to hear Apotex's arbitration claims on their full merits. As explained herein, Apotex invested millions of dollars in developing its products and preparing and filing its ANDAs with the U.S. Food and Drug Administration ("FDA") in the United States, in accordance with U.S. statutory and regulatory requirements, in order to attain an economic benefit in the United States. Indeed, the sole purpose of Apotex's development and submission of its ANDAs was to obtain FDA approval to commercialize its ANDA products in the United States. These ANDAs (and everything that went into their development and submission) were and are manifestly a United States investment—that is, "property, tangible or intangible, acquired in the expectation or used for the purpose of economic benefit or other business purposes." No more is required for—and indeed it is hard to imagine a clearer case of—an investment under NAFTA.