definiens: shall mean the expiration of thirty ( 30 ) days following receipt by GENENTECH of a notice fromthe FDA to GENENTECH ( or its Sublicensee ) that the FDA has received an IND for a Licensed Product filed by GENENTECH(or its Sublicensee ) for the purpose of obtaining approval or authority to commence human clinical trials in the United Stateswith such Licensed Product ; PROVIDED, HOWEVER, that if the FDA puts a clinical hold on the IND during such thirty ( 30)day period, the term shall mean that date during the term of this Agreement when GENENTECH ( or itsSublicensee ) receives written confirmation from the FDA that the clinical hold has been removed and that GENENTECH ( orits Sublicensee ) has the approval or authority to commence human clinical trials of such Licensed Product under such IND inthe United States . Notwithstanding anything set forth herein, shall not be deemed to have occurred in anycircumstances where GENENTECH ( or its Sublicensee ) withdraws any IND filed with the FDA for a Licensed Product at anytime prior to the commencement of human clinical trials with such Licensed Product in the United States