Supplemental Development Studies definition
Supplemental Development Studies means preclinical studies and Clinical Trials to be undertaken by Synthelabo in order to fulfill the requirements for Registration Approval and Reimbursement Approval in any Territory Country which have not fully been satisfied by the Core Development Studies.
Examples of Supplemental Development Studies in a sentence
PRAECIS shall supply Synthelabo with all Licensed Products required for Synthelabo to conduct the Supplemental Development Studies pursuant to the Supplemental Development Plan.
Such supply of Licensed Products shall be (i) at a price equal to PRAECIS' COGS if Synthelabo is not entitled, pursuant to Section 4.5, to receive reimbursement from PRAECIS for a portion of its Development Costs incurred in connection with such Supplemental Development Studies and (ii) otherwise charged to Synthelabo as a Development Cost pursuant to Sections 1.13 and 4.5.