definiens: means, with respect to the development, manufactu re and/or commercialization of a Product and any other activi ties conducted under the Agreement with respect to a Product, the level of efforts and resources commonly used in the pharmaceutical or biotechnology industry by a similarly situated company of similar size and resources in t he exercise of its reasonable business discretion w ith respect to a product at a similar stage in its development or product life, that is of similar commercial potenti al, taking into account actual or potential issues including, but n ot limited to, issues relating to efficacy, safety, manufacturing, quality, supply, regulatory or market exclusivity, patents and intellectual property protection, produ ct profile, labeling, pricing, reimbursement, distribution, mar ket potential, competitive conditions, the regulato ry environment, and any other technical, legal, scient ific, medical, operational or commercial factors th at could reasonably be expected to affect profitability of t he product