definiens: shall mean a pharmaceutical product containing ( i ) 12.5 mg, 25 mg, or 100 mg of API formulated inDuraSolv ® technology and packaged in 100 - count bottles for the United States ; ( ii ) 150 mg or 200 mg APIformulated in DuraSolv ® technology and packaged in 100 - count bottles for the United States, subject to successfuldevelopment and validation ; ( iii ) Institutional Use Product for the United States ; ( iv ) 12.5 mg, 25 mg or 100 mg, ofAPI formulated in DuraSolv ® technology and packaged in 100 - count bottles for Europe ; and ( v ) 12.5 mg, 25 mg or100 mg of API formulated in DuraSolv ® technology and packaged in 6 - count blisters for Europe, subject tosuccessful development and validation . ” 3