definiens: means, with respect to the eﬀorts to be expended by a Partypertaining to a particular objective, the eﬀorts and resources commonly used by a similarly situated ( with respect to size, stage of development and assets ) biotechnology or pharmaceutical company for similarly situated pharmaceutical productsor product candidates, as applicable, to accomplish a similar objective under similar circumstances exercising reasonablebusiness judgment, taking into account the following factors to the extent applicable : ( a ) stage of development ; ( b ) eﬃcacyand safety issues ; ( c ) characteristics of competitive products in or anticipated to be in the marketplace as well as the natureand extent of market exclusivity ( including patent coverage and regulatory exclusivity ) and any Third Party intellectualproperty rights ; ( d ) process development, scale - up or manufacturing ; ( e ) cost and likelihood of obtaining regulatory approval;(f ) actual or anticipated regulatory authority approved labeling ; and ( g ) projected or actual economic return