definiens: in this Section 9.5 shall mean the right for the distributor to package Licensed Products supplied in unpackaged bulk form into individual ready - for - sale packs . Notwithstanding the foregoing, if the Lead Licensed Product meets the Target Product Characteristics in the Key Trials conducted pursuant to the Initial Development Plan, as may be amended for any additional Phase III Clinical Trial, then until the [ third ( 3rd ) ] anniversary of ( tbe First Commercial Sale ofthe Lead Licensed Product ], [COMPANY] and its Affiliates or any joint venture or similar collaborative enterprise in which [COMPANY] owns an interest shall ( continue to directly conduct distribution, marketing and sales opcratioos of thc Liceosed Product within the United States 00 a scale substantiallv similar to the scale 00 which it and its Affiliates couduct such opel'atious with respect to similar pharmaceutical products aud the services to be performed by any Distributor are intendcd to servc only as a supplement io the activities of Astt'aZeneca and its Affiliates ( and, where applicable, such collaborative enterprises ) ], For the avoidance of doubt, [COMPANY] and its Affiliates shall have the right to appoint Distributors ( i ) ( outside the United States at any time I, ( ii ) ( within thc United States following the failure of the Lead Licensed Product to meet the Target Product Characteristics iu the Kcy Trials conducted pursuant to the Initial Development Plan, as may be amended for any additional Phase 1I1 Clinical rfriall, or ( iii ) following the ( third ( 3rd ) ] anniversary of the First Commercial Sale of the Lead Licensed Product