definiens: means, with respect to a Licensed Product, [ its safety and efficacy, its time ) and cost to [ develop, the competitiveness of existing and expected alternative products ] and the nature and extent of [ market exclusivity ( including Patent coverage and Regulatory Exclusivity ), the likelihood of regulatory approval, including its .·easonably expected or actual labeling, its reasonably expected or actual pricing, reimbursement and formulary ] status, [ its reasonably expected or actual profitability, its reasonably expected or actual rate of return, including the amounts of marketing and promotional expenditures ] with respect to the Licensed Product, [ the likelihood, tinting or existence of Generic Versions of the Licensed Product, ] the cost of [ any studies necessary or reasonably useful to obtain favorable pricing, reimbursement or formulary ] status for the Licensed Product, including with respect to the [ ' essential equivalence ' of the Licensed Product with other products ], any other risks related to the [ conduct of such studies ], including any impact such [ studies could have on other geographic markets ], and, with respect to the factors that [ may be considered by AstraZeneea, ] the impact of any Ibreach or other failure by MAP to perform its obligations under Article 4, if any [