definiens: shall mean eac h drug or other product which is identified, confirmed, characterized, developed, validated or tested using the Technology or which is within the scope of any claim in an issued patent or pending application included in the Patent Rights ; provided, however, with respect to any Licensed Product which is a drug or other product that is already a Licensed Product but for which a new NDA or SNDA for a new indication, use or patient population is filed ( the ) each shall be considered a distinct and separate Licensed Product for purposes of this Agreement, excluding new formulations or changes in dosage strengths of an already approved Licensed Product, unless such new formulation or dosage strength 2 < PAGE > addresses the same indication or use among the same patient or user population as the Referenced Licensed Product . For the avoidan ce of doubt, a new drug combination that meets the foregoing definition sha ll be deemed a new Licensed Product unless such new drug combination addresses the same indication or is targeted for use among substantially the same patie nt or user population as the Referenced Licensed Product