definiens: means : ( a ) with respect to the efforts to be expended, or considerations to be undertaken, by a Party or its Affiliate with respect to any objective, activity or dec ision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as such Party would normally use to accomplish a similar objective, activity or decision under similar circumstances ; and ( b ) with respect t o Development and Commercialization ( each, as defined in the Commercialization Agreement ) of any Product for any indication by a Party, efforts and resources consistent with those efforts and resources commonly used by a similarly situated biotechnology co mpany with respect to a product owned by it or to which it has similar rights, which product is at a similar stage in its development or product life and is of similar market potential taking into account : ( i ) issues of efficacy, safety, and expected an d actual approved labeling ; ( ii ) the expected and actual competitiveness of alternative products sold by Third Parties in the marketplace ; ( iii ) the expected and actual product profile of the Product ; ( iv ) the expected and actual patent and other proprieta ry position of the Product ; ( v ) the likelihood of Regulatory Approval given the regulatory structure involved ; and ( vi ) the expected and actual profitability and return on investment of the Product