definiens: means, with respect to a Party’sobligation to perform or achieve a specified obligation for the Product or generally under thisAgreement, the efforts, expertise, degree of skill, and resources that are comparable in qualityand scope to those efforts, expertise, degree of skill and resources that are generally used bysuch Party to perform or achieve a comparable obligation for a pharmaceutical productControlled by such Party, which has the same regulatory requirements or status ( for example, requires a prescription or is available over - the - counter ), is at a comparable stage of developmentor product life as the Product, and that has similar market potential as the Product, taking intoaccount relative safety and efficacy, product profile, the competitiveness of the marketplace, relevant regulatory circumstances, the extent of market exclusivity, and other relevant factors thenprevailing, including technical, legal, payer environment, scientific and/or medical factors, but inany event, a Party ’s effort shall be no less than the effort that a comparable pharmaceuticalcompany would expend with respect to a comparable pharmaceutical product Controlled by suchcompany taking into consideration the factors outlined above