definiens: means, with respect to the Product, using such efforts and resources normally used byPersons of comparable size within the pharmaceutical industry for the development and seeking of regulatoryapproval for a pharmaceutical product having similar market potential as the Product at a similar stage of itsdevelopment or product life, taking into account all relevant factors, including issues of market exclusivity ( includingpatent coverage, regulatory and other exclusivity ), product profile, including efficacy, safety, tolerability, methods ofadministration and convenience, product labeling ( including anticipated product labeling ), other product candidates, thecompetitiveness of alternative products in the marketplace or under development ( other than any such product ownedor controlled by Parent Holdco or any -2 - Affiliate or that Parent Holdco or any Affiliate is discovering, researching, developing, manufacturing orcommercializing along with one or more collaborators ), the launch or sales of a generic or biosimilar product, theregulatory structure involved, the regulatory environment and the expected profitability of the applicable product(including development costs, pricing and reimbursement, cost of goods and all other costs associated with theapplicable product ), and relevant technical, commercial, financial, legal, scientific and medical factors . For theavoidance of doubt, Section 4.4 shall apply to Parent Holdco and its successors and assigns