definiens: shall mean efforts and resources commonly used in the pharmaceutical industry fora product at a similar stage with the Products in its development or product life and is of similar market1 * * * Text Omitted and Filed Separately with the Securities and ExchangeCommission . Confidential Treatment Requested Under17 C.F.R. Sections 200.80(b)(4 ) and 240.24b-2 potential taking into account efficacy, safety, Regulatory Authorities ’ approved labeling, the competitiveness ofalternative products in the marketplace, the patent and other proprietary position of the product, the likelihood ofRegulatory Approval given the regulatory structure involved, the profitability of the product including the royaltiespayable to licensors of patent rights, alternative products and other relevant factors . Commercially Reasonable Effortsshall be determined on a market - by - market basis for a particular product, and it is anticipated that the level of effort willchange over time, reflecting changes in the status of the Products and the market involved