definiens: means, with respect to the performance of any Development or commercialization activities with re spect to a Product, the carrying out of such activi ties using the level of efforts and resources comparable to th e efforts and resources commonly used in the pharma ceutical or biotechnology industry for compounds or products of similar market potential at a similar stage in development or product life considering conditions then prevailing and taking into account, without li mitation, issues of safety and efficacy, expected and actual cost, expense and time to develop, expected and act ual profitability, expected and actual competitiveness of alternative Third Party products ( including gene ric products ) in the marketplace, the nature and extent of expected and actual market exclusivity ( includi ng patent coverage and regulatory exclusivity ), the expected and actual reimbursability and pricing, the expecte d and actual amounts of marketing and promotional expendi tures required, product profile ( including the expe cted and actual labeling ), anticipated timing of commercial entry, the regulatory environment and status of the product ( including the likelihood of regulatory approval ), and other relevant scientific, technical and commer cial factors