1. The disputing parties in this arbitration have agreed that certain of the materials in this arbitration are confidential, non-public documents or information, and are therefore to be protected from disclosure pursuant to this Agreement and Order.
2. For the purposes of this Agreement and Order: a. “disputing party” means, in the case of the Claimants, Apotex Holdings Inc. (Canada), Apotex Inc. (Canada), and Apotex Corp. (United States), and their successors and assigns (“Apotex”), and in the case of the Respondent, the Government of the United States of America;
b. “Centre” means the International Centre for Settlement of Investment Disputes;
c. “confidential information” means any information designated by a disputing party as confidential. A disputing party may designate as confidential, and protect from disclosure:
i. any confidential commercial or financial information, including information meeting the definition in 21 C.F.R. § 20.61(b); or
ii. any trade secret information meeting the definition in 21 C.F.R. § 20.61(a);
iii. any other sensitive non-public information that (a) as of the date of production, has been subject to strict internal controls limiting its dissemination by the disputing party and (b) if improperly disclosed, is likely to cause the disputing party or another person substantial harm; or
iv. any information that could otherwise be protected from disclosure by legislation, including, but not limited to, as amended, the Freedom of Information Act, 5 U.S.C. § 552, the Trade Secrets Act, 18 U.S.C. § 1905 or the Food, Drug and Cosmetic Act, 21 U.S.C. § 331(j).