definiens: in the CLA are hereby amended to read, which is defined as follows : ‘ means, with respect to the efforts to be expended, or considerations tobe undertaken, by a Party or its Affiliate with respect to any objective, activity or decision to be undertakenhereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as such Partywould normally use to accomplish a similar objective, activity or decision under similar circumstances, itbeing understood and agreed that with respect to the development, manufacture, seeking and obtainingregulatory approval, or commercialization of the Compound or Product, such efforts and resources shall beconsistent with those efforts and resources commonly used by a Party under similar circumstances forsimilar compounds or products owned by it or to which it has similar rights, which compound or product, asapplicable, is at a similar stage in its development or product life and is of similar market potential taking into 1 account : ( a ) issues of efficacy, safety, and expected and actual approved labeling, ( b ) the expected andactual competitiveness of alternative products sold by third parties in the marketplace, ( c ) the expected andactual product profile of the Compound or Product, ( d ) the expected and actual patent and other proprietaryposition of the Compound or Product, ( e ) the likelihood of regulatory approval given the regulatory structureinvolved, including regulatory or data exclusivity, ( f ) the expected and actual profitability and return oninvestment of the Compound or Product, or other compounds or products in a Party ’s portfolio of compoundsor products, taking into consideration, among other factors, expected and actual ( 1 ) third party costs andexpenses, ( 2 ) royalty, milestone and other payments to third parties and SPI, and ( 3 ) the pricing andreimbursement relating to the Product(s ) . Commercially Reasonable Efforts shall be determined on anindication / dosage - by - indication / dosage basis for the Compound or Product, as applicable, and it is anticipatedthat the level of effort and resources that constitute with respect to aparticular indication will change over time, reflecting changes in the status of the Compound or Product, asapplicable