definiens: means : ( a ) with respect to Development of a Produ ct, the efforts and expenditures required to obtain Regulatory Appr oval that would be employed by a company in the pharmaceutical or biotechnology industry of similar size and resources to LICENSEE for a product of similar commercial potential with similar rights ; a nd ( b ) with respect to Commercialization of a Product, the efforts and expenditures that would be employed by a company in the pharmaceutical or biotechnology industry of similar size and resource s to LICENSEE and for a product of similar commercial potential with similar rights, in each c ase of ( a ) and ( b ) considering all relevant factors at the relevant time, including anticipated and actual competitiveness of the marketplace, proprietary position ( e.g., patent coverage ), regulatory status, supply chain, profitability ( including pricing an d reimbursement status achieved ), relative safety and efficacy of, and other relevant factors, including technical, legal, scientific or medical factors