definiens: means, with respect to any country in the Territory, any product containing any Compound fortopical administration in the Field sold by a Third Party, other than a Licensed Product sold pursuant to the rightsgranted under this Agreement, that is ( A ) with respect to products sold in the U.S., ( i ) approved through an ANDA, oran application under Section 505(b)(2 ) of the FD&C Act, that references any NDA for Licensed Product ( or futurefunctional equivalent ) listed in the FDA Publication ( known as the Orange Book ), submitted by a Third Party and ( ii ) rated as a therapeutic equivalent to thecorresponding Licensed Product sold in and designated as substitutable for Licensed Product at the pharmacy levelunder any applicable administrative or formulary designation or by decision of the prescriber or the pharmacist, or(B ) with respect to products sold in any jurisdiction in the Territory other than the U.S., a product that ( i ) has obtaineda regulatory approval granted in reliance, in whole or in substantial part ( e.g. on safety or efficacy data with respect tothe Compound ) on a prior Regulatory Approval granted for a Licensed Product ; ( ii ) is substitutable by a pharmacistunder applicable local Law in the country of sale, and/or would reasonably be expected based on rules of substitutionapplicable in Germany as of the Execution Date, to be substitutable by a pharmacist under German law ( whether ornot at the date of the relevant sales of such product, such product has been submitted 8EXECUTION DRAFT for approval in Germany ), and ( iii ) has the same Product Label as the corresponding Licensed Product or is approvedfor use for a subset of indications included in the Product Label of the corresponding Licensed Product, or by anyother ways has been approved and sold under any foreign equivalent of the processes and criteria described in clause(A )