definiens: means, with respect to a particular Licensed Prod uct in a particular country in the Territory, any pharmaceutical produc t that ( a ) is claimed to be interchangeable with su ch Licensed Product or otherwise references or relies on the pr ior approval ( or the safety or efficacy data submit ted in support of the prior approval ) of such Licensed Product to support a Drug Approval Application submitted under Section 351(k ) of the PHSA or any corresponding for eign application in the Territory ; ( b ) is approved for sale for at least one indication that is the same as an indication for which the License Product is approve d * * * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN T HIS DOCUMENT, MARKED BY [ * * * ], HAS BEEN OMITTED AND FILED SEPARATELY WITH T HE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED