definiens: means, with respect to the Product, a product sold by a Third Party that ( A ) contains aCompound as an active ingredient, and ( B ) has been approved for sales introduction into interstate commerce byreference to the Product pursuant to ( 1 ) Section 505(b)(2 ) or Section 505(j ) of the United States Food, Drug, and CosmeticAct ( 21 U.S.C. 355(b)(2 ) and 21 U.S.C. 355(j ), respectively ), or ( 2 ) any similar approval in any other country of theLicensed Territory, which similar approval is based on reference to the Regulatory Approval for the Product in suchcountry and a demonstration of bio - equivalence or similarity to the Product . At any time following introduction of theinitial Generic Version of the Product in a country achieving a market share of at least the Threshold and upon writtennotice of CTI expressing concern regarding the continued commercial viability of the Product in such country, theParties agree to negotiate in good faith a mutually acceptable strategy to address CTI ’s concerns with a view towardpreserving the historic economic balance and profit splits between the Parties