Commercially Relevant Factors means, with respect to a Licensed Antibody or Product, all relevant factors that may affect the Development, Regulatory Approval or Commercialization of such Licensed Antibody or Product, including (as applicable): safety, efficacy, quality or stability; product profile (including product modality, category and mechanism of action); stage of Development or life cycle status; Development, Regulatory Approval, manufacturing, and Commercialization costs and risk; feasibility and cost of manufacture; the likelihood of obtaining Regulatory Approvals (including satisfactory price approvals) and the timing of such approvals; the current guidance and requirements for Regulatory Approval and the current and projected regulatory status, including expectations for post-approval commitments; labeling or anticipated labeling; the then-current competitive environment and the likely competitive environment at the time of projected entry into the market; past performance; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; pricing or reimbursement changes in relevant countries; proprietary position, strength and duration of patent protection and anticipated exclusivity; and such Party’s [*].
Commercially Relevant Factors 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 Development or life cycle status; (d) Development, Marketing Authorization Approval, Manufacturing, and Commercialization costs and risk; (e) feasibility of manufacture; (f) the likelihood of obtaining Marketing Authorization Approvals and the timing 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 environment 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) proprietary 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.
Commercially Relevant Factors means, with respect to an Eisai Collaboration Product or an Option Product, as the case may be, including as applicable to such product, all relevant factors that may affect the Development, Regulatory Approval or Commercialization of such Eisai Collaboration Product or such Option Product, including (as applicable): safety, efficacy, quality or stability; product profile (including product modality, category and mechanism of action); stage of Development or life cycle status; Development, Regulatory Approval, Manufacturing, and Commercialization costs and risk; feasibility of Manufacture; the likelihood of obtaining Regulatory Approvals (including satisfactory price approvals) and the timing of such approvals; the current guidance and requirements for Regulatory Approval and the current and projected regulatory status; labeling or anticipated labeling; the then-current competitive 132539616_1 environment external to the Parties and the likely competitive environment external to the Parties at the time of projected entry into the market (i.e., not taking into consideration any other Eisai Collaboration Products, Option Products or other products in which a Party has an economic interest); past performance; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; pricing or reimbursement changes in relevant countries; proprietary position, strength and duration of patent protection and anticipated exclusivity; and other scientific, technical, regulatory, and commercial factors that the decision-making Party reasonably believes to be relevant to such Eisai Collaboration Product or Option Product, as applicable.
More Definitions of Commercially Relevant Factors
Commercially Relevant Factors means, with respect to a Collaboration Product, including as applicable to such Collaborative Product, all relevant factors that may affect the Development, Regulatory Approval or Commercialization of such Collaboration Product, including (as applicable): safety, efficacy, quality or stability; product profile (including product modality, category and mechanism of action); stage of Development or life cycle status; Development, Regulatory Approval, manufacturing, and Commercialization costs and risk; feasibility of manufacture; the likelihood of obtaining Regulatory Approvals (including satisfactory price approvals) and the timing of such approvals; the current guidance and requirements for Regulatory Approval and the current and projected regulatory status; labeling or anticipated labeling; the then-current competitive environment external to the Parties and the likely competitive environment external to the Parties at the time of projected entry into the market (i.e., not taking into consideration any other Collaboration Products or other products of the Parties); past performance; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; pricing or reimbursement changes in relevant countries; proprietary position, strength and duration of patent protection and anticipated exclusivity; and other scientific, technical, regulatory, and commercial factors that the decision-making Party reasonably believes to be relevant to such Collaboration Product.