definiens: shall mean, with respect to the eﬀorts to be expended by a Party withrespect to any objective, those reasonable, diligent, good faith eﬀorts to accomplish such objective that a similarly si tuatedpharmaceutical or biotechnology company in the exercise of i ts reasonable business discretion would normally use toaccomplish a similar objective under similar circumstances . Wit h respect to any objective relating to the Development orCommercialization of a Product by a Party, shall mean those eﬀorts and resourcesnormally used by a similarly situated pharmaceutical or bio technology company in the exercise of its reasonable businessdiscretion with respect to a product owned or controlled by such Party, or to which such Party has similar rights, whichproduct has similar product characteristics, is of similar mar ket potential and is at a similar stage in its developmen t or life asis such Product, taking into account all relevant scientiﬁc, te chnical, legal, clinical, operational, economic and commer cialfactors that may aﬀect the Development or Commercializatio n of a product, including ( as applicable ): actual and po tentialissues of safety, eﬃcacy or stability ; expected and actual prod uct proﬁle ; stage of development or life cycle status ; actualand projected Development, regulatory, Manufacturing a nd Commercialization costs ; timelines and budgets ; any issuesregarding the ability to Manufacture or have Manufactur ed the product ; the likelihood of and timing for obta ining RegulatoryApproval or Commercialization Approval ; approved labeling or anticipated labeling ; the then - current competitiveenvironment and the likely competitive environment at the time of projected entry into the market, including the expectedand actual competitiveness of alternative products in the m arketplace ; past performance of the product or similar pr oducts;present and future market potential ; existing or project ed pricing, sales, reimbursement and proﬁtability ; and exp ected andactual proprietary position, strength and duration of p atent protection and anticipated regulatory or other e xclusivity as suchcompany would normally use to accomplish a similar objective under similar circumstances . To the extent that theperformance of a Party ’s obligations hereunder is adversely aﬀected by the other Party ’s failure to perform its oblig ationshereunder, the impact of such performance failure will be taken into account in determining whether such Party ha s used itsCommercially Reasonable Efforts to perform any such affected obligations