definiens: Product " shall mean a pharmaceutical product containing ( i ) 12.5 mg, 25 mg, or 100 mg of API formulated in DuraSolv ® technology and packaged in 100 - count bottles for the United States ; ( ii ) 150 mg or 200 mg API formulated in DuraSolv ® technology and packaged in lOO - count bottles for the United States, subject to successful development and validation ; ( iii ) Institutional Use Product for the United States ; ( iv ) 12.5 mg, 25 mg or 100 mg, of API formulated in DuraSolv ® technology and packaged in 100 - count bottles for Europe ; and ( v ) 12.5 mg, 25 mg or 100 mg of API fOlmulated in DuraSolv ® technology and packaged in 6 - count blisters for Europe, subject to successful development and validation . Institutional Use Product " shall mean 12.5 mg, 25 mg or 100 mg of API formulated in DuraSolv ® technology and packaged in 6 - count blisters labeled " For Institutional Use Only . Notwithstanding the foregoing, OraSolv ® technology shall be used for the production ofInstitutional Use Product until validation with the DuraSolv ® Technology