definiens: means, with respect to an IND for a Licensed Prod uct that was filed by Licensee, or any Affiliate or Sublicensee of Licens ee, ( a ) in the U.S., the date that is [ * * * ] days fo llowing the filing of the first IND for such Licensed Product, if Licensee or its Affiliates or Sublicensees has not received any notice of a clinical hold or any other administ rative delay from the FDA during such [ * * * ] day per iod ; provided that, if Licensee or its Affiliate or Sublicensee d oes receive a notice of a clinical hold or there is such other administrative delay, then for such Licensed Product will be the date on wh ich the FDA lifts such clinical hold or such other administ rative delay is otherwise resolved and the FDA firs t allows the Licensed Product to be administered to a human purs uant to such IND, or ( b ) in other regulatory jurisd ictions outside the U.S., the date on which such Licensed P roduct is first permitted by the applicable Regulat ory Authority of such jurisdiction to be administered t o a human pursuant to an IND in accordance with App licable Law