definiens: means on a country - by - country and product - by - product basis ( such product, the ), a pharmaceutical product ( other than the Reference Product ) that ( a ) is sold by any Third Partyin such country ( other than Takeda ’s licensees or sublicensees or any other Person in a chain of distributionoriginating from Takeda, its Affiliates or sublicensees ), ( b ) contains the same active ingredients as the applicableReference Product and if such Reference Product contains more than one active ingredient, the ratio of the dosage ofeach active ingredient in such pharmaceutical product as compared to the total dosage of all active ingredients insuch pharmaceutical product is the same as such ratios for such Reference Product, and ( c ) is approved formarketing or sale in such country based on an NDA, an abbreviated new drug application submitted to the FDApursuant to Section 505(j ) of the FD&C Act or the foreign equivalent of any of the foregoing, in each case that relieson or references any finding of safety and/or effectiveness in the Regulatory Approval for such Reference Product, including pursuant to Section 505(b)(2 ) and/or 505(j ) of the FD&C Act or any foreign equivalent thereof