definiens: shall mean, coll ectively and individually, a study and studies in which a Product is tested in humans in order to confirm that a Product substantially meets its specifications or is otherwise acceptable to Cornerstone in its reasonable discretion . Neos shall provide its r easonable assistance to a CRO in connection with the Clinical Studies, including providing samples manufactured by Neos necessary for such Clinical Studies . Cornerstone recognizes and agrees that Clinical Studies may have to be repeated in connection with any Product and/or Regulatory Approvals ( hereinafter defined ), Cornerstone shall, during the pendancy of the Clinical Studies on the First Product ( or any other Product, as applicable ), begin assembling materials for a NDA for the Product . Cornerstone shal l, if Clinical Studies show that the First Product ( or another Product ) meets its specifications or is otherwise acceptable to Cornerstone in its reasonable discretion, use its commercially reasonable efforts to assemble to remainder of the materials and t he application for such NDA . Neos shall have the right to participate and consult in any work relating to regulatory filings related to any Product at its cost and Neos shall provide reasonable assistance to Cornerstone, as provided in Section 6 . hereof, i n connection with the chemistry, manufacturing and controls section of each regulatory filing submitted in connection with a Product pursuant to the terms hereof . If the Clinical Study shows that the First Product ( or another Product ) meets its specificati ons and is otherwise acceptable to Cornerstone in its reasonable discretion, then Cornerstone shall move forward with the submission and prosecution of the NDA, which Cornerstone shall use its reasonable efforts to file and prosecute as soon as reasonably possible . Neos acknowledges that the continued prosecution of an NDA and related commercialization activities are subject to the continued generation of favorable data necessary for the NDA related to the Product as determined by Cornerstone in its reasona ble discretion . In connection with the foregoing, Cornerstone shall determine, in its reasonable discretion, whether any Investigational New Drug Application ( ), pre -IND meeting or other regulatory submissions, approvals or requirements are reasonably necessary ( all of which, together with each NDA on a Product, and the applications and submissions in connection with each of the foregoing, are referred to herein collectively as ) and arrange for the completion thereof, with the re asonable assistance of Neos . All Regulatory Approvals shall be in the name of and owned by Cornerstone and Cornerstone shall designate Neos as the manufacturer, and no other person or entity, in each Regulatory Approval or any time thereafter so long as Ne os is able and is approved by the FDA to manufacture in accordance with the terms of the relevant Manufacturing Agreement the Product that is the subject of a Regulatory Approval . Cornerstone agrees to use its commercially reasonable diligent efforts to co mplete the milestones related to Regulatory Approval of the First Product by the dates contained in the First Product Development Plan