definiens: means, with respect to a product, all relevant factors that may affect the Development, Manufacturing, or Commercialization of such product, including ( as applicable ): ( a ) safety, efficacy, quality or stability ; ( b ) product profile ( including product modality, category, and mechanism of action ) ; ( c ) stage of Developme nt or life cycle status ; ( d ) Development, Marketing Authorization Approval, Manufacturing, and Commercialization costs and risk ; ( e ) feasibility of manufacture ; ( f ) the likelihood of obtaining Page 5 of 60 Marketing Authorization Approvals and the ti ming thereof ; ( g ) the current guidance and requirements for Marketing Authorization Approval and the current and projected regulatory status ; ( h ) labeling or anticipated labeling ; ( i ) the then -current competitive environment and the likely competitive envi ronment at the time of projected market entry ; ( j ) past performance ; ( k ) present and future market potential ; ( 1 ) existing or projected pricing, sales, reimbursement, and profitability ; ( m ) pricing or reimbursement changes in relevant countries ; ( n ) propri etary position, strength, and duration of patent protection and anticipated exclusivity ; and ( o ) other scientific, technical, regulatory, and commercial factors that the decision -making Party reasonably believes in good faith to be relevant to such product