definiens: means : ( a ) where applied to carrying out specific tasks and obligations of aParty under this Agreement other than development, manufacture or commercialization of a Product, expending reasonable, diligent, good faith efforts and resources to accomplish such task or obligation as a similarly situated pharmaceutical orbiotechnology company ( on its own or acting through any of its Affiliates, sublicensees or subcontractors ) would normallyuse to accomplish a similar task or obligation under similar circumstances ; and ( b ) where applied to the development, manufacture or commercialization of a Product, those reasonable efforts and resources customarily used by such Party withrespect to a similar pharmaceutical product Controlled by such Party, which product is at a similar stage in its development orproduct life and is of similar market potential in the applicable market taking into account efficacy, safety profile, labeling, the then - current and expected competition in the applicable market, the likely timing of entry into the market, the expectedextent and speed of market penetration, the patent and other proprietary position of the Product, the likelihood of regulatoryapproval given the regulatory structure involved, the profitability of the Product, including the cost of manufacture, royaltiespayable to licensors of patent or other intellectual property rights, alternative products and other relevant factors and otherscientific, clinical or commercial factors . With respect to subpart ( b ) of this definition, Commercially Reasonable Efforts shallbe determined on a market - by - market and indication - by - indication basis for a particular Product, and it is anticipated that thelevel of effort shall be different for different markets and different indications, and shall change over time, reflecting changesin the status of the Product and the market(s ) and indication(s ) involved