definiens: means [ * * * * * ] relevant factors that may affect the Development, Regulator y Approval or Commercialization of a Compound or Prod uct, [ * * * * * ] ( as applicable ): actual and potential issues of safety, efficacy or stability ; product profile ( inc luding product modality, category and mechanism of action ) ; stage of development or life cycle status ; actual and pro jected Development, Regulatory Approval, Manufactur ing, and Commercialization costs ; any issues regarding the a bility to Manufacture or have Manufactured any Comp ound or Product ; the likelihood of obtaining Regulatory Approvals ( including satisfactory Price Approvals ) ; the timing of such approvals ; the current guidance and require ments for Regulatory Approval for the Product and s imilar products and the current and projected regulatory s tatus ; labeling or anticipated labeling ; the then - c urrent competitive environment and the likely competitive environment at the time of projected entry into the market ; past performance of the Product or similar products ; present and future market potential ; the ability to obtain, due to factors beyond [COMPANY] ’s reasonable control, adeq uate supply of any Compound or Product, or any comp onent thereof, from any Third Party as may be required to Develop, secure Regulatory Approval for or Commerc ialize any Compound or Product ; Patent Rights of a Third P arty ; existing or projected pricing, sales, reimbur sement and profitability ; pricing or reimbursement changes in relevant countries ; proprietary position, strength and duration of patent protection and anticipated exclusivity ; a nd other relevant scientific, technical, operationa l and commercial factors