definiens: means, with respect to the efforts to be expended, by a Party or its Affiliate with respect to any objective to be undertaken hereunder, reason able, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar ob jective under similar circumstances, it being understood an d agreed that with respect to applicable activities, such efforts and resources shall be consistent with those effort s and resources commonly used by such Party under s imilar circumstances for similar products owned by it or t o which it has similar rights that are at a similar stage in their development or product life and are of similar mark et potential as the applicable Licensed Product tak ing into account : ( a ) issues of efficacy, safety and expecte d and actual approved labeling, ( b ) the expected an d actual competitiveness of alternative products sold by Thi rd Parties in the marketplace, ( c ) the expected and actual product profile, ( d ) the expected and actual patent and other proprietary position, ( e ) the likelihood of regulatory approval given the regulatory structure involved, i ncluding regulatory or data exclusivity, and ( f ) th e expected and actual profitability and return on investment of th e applicable Licensed Product, or other products in a Party ’s portfolio of products, taking into consideration, a mong other factors, the expected or actual ( i ) Thir d Party costs and expenses, ( ii ) royalty, milestone and other pay ments payable to Third Parties and to MTEM, and ( ii i ) pricing and reimbursement . Commercially Reasonable Efforts shall be determined on a country - by - country and indication - by - indication basis for each Licensed Pr oduct, as applicable, and it is anticipated that th e level of effort and resources that constitute with respect to a particular country o r indication will change over time, reflecting changes in the st atus of the applicable Licensed Product and the cou ntry(ies ) involved . Notwithstanding the foregoing, neither Pa rty shall be obligated to Develop, seek Regulatory Approval for, or Commercialize a Licensed Product : ( A ) that, in its reasonable opinion after discussion with th e other Party, caused or is likely to cause a fatal, life - threaten ing or other adverse safety event that is reasonabl y expected, based upon then available data, to preclude obtaining Reg ulatory Approval for such Licensed Product, or, if Regulatory Approval of such Licensed Product has already been obtained, to preclude continued marketing of such L icensed Product ; or ( B ) in a manner inconsistent with Appli cable Law