definiens: means all relevant factors that may affect the De velopment or Commercialization of a Licensed Drug Candidate or L icensed Product, including ( as applicable ), safety, tolerability, stability and efficacy ; the product p rofile ; the stage of development or life cycle stat us ; the likelihood and timing of obtaining Regulatory Appro vals and Reimbursement Approvals ; the current guida nce and requirements for Regulatory Approval for the Li censed Drug Candidate or Licensed Product and simil ar products and the current and projected regulatory s tatus ; any issues regarding the ability to Manufact ure or have Manufactured the Licensed Drug Candidate or License d Product ; -14- existing or projected pricing, sales, reimbursement and profitability ; the then - current competitive en vironment and the likely competitive environment at the time of projected entry into the market ; past performanc e of the Licensed Drug Candidate or Licensed Product or simi lar products ; present and future market potential ; pricing or reimbursement changes in relevant countries ; propri etary position, strength and duration of patent pro tection and anticipated market exclusivity, actual and projecte d Development, Manufacturing, having Manufactured a nd Commercialization costs ; promotable claims and heal th economic claims, and any other relevant scientif ic, technical, operational and commercial factors