definiens: means the following Development activities : ( i ) Nabi-4512, a Phase II Clinical Trialproof of concept and long - term safety follow - up ; ( ii ) Nabi-4513, a Phase II Clinical Trial dose schedule optimization andlong - term safety follow - up ; ( iii ) Nabi-4514 and Nabi-4515, two Phase III Clinical Trials, Multi - Center, Randomized, Double - Blind, Placebo - Controlled Studies to Assess Efficacy, Immunogenicity and Safety of 3’-aminomethylnicotine - P. aeruginosa r - Exoprotein A Conjugate Vaccine ( NicVAX ) as an Aid to Smoking Cessation ; and ( iv ) Nabi-4516, Conformance Lot Studies;provided, in each of the foregoing ( ( i ) through ( iv ) ( inclusive ) ), where such Development activities are undertaken andconducted in accordance with the Development Plan . All such studies have been or will be conducted in the United States . Forclarity, the post - Phase III Clinical Trials mentioned in the SPA for alternative indications, regarding a relapse preventionstudy and a booster follow - up study for maintenance and salvage are excluded from the definition of NicVAX DevelopmentActivities hereunder . If any such study is conducted by Nabi prior to Exercise, it would be considered Complementary R&Dfor purposes of this Agreement