definiens: means ( i ) with respect to an IND for a XEN901 Product i n SCN8A - EE, Full IND Acceptance in SCN8A -EE ; or -2- ( ii ) with respect to an IND for a XEN901 Product in a Ma jor Indication, either ( a ) [ † ] days after submission of such IND to a Regulatory Authority ( s uch [ † ] day period, the Initial Period ” ), if at such time the Regulatory Authority has confirmed in writing that it has no comments to such IND, or ( b ) if the Regulatory Authority indicates during the Initial Period that it will have comments t o the IND, either ( 1 ) [COMPANY] ’s failure to notify Xenon of a [COMPANY] Negative IND Decision pursuant to Section 6.3(b ) within [ † ] days after [COMPANY] ’s receipt of such comments or ( 2 ) the JSC ’s failure to make a JSC Negative IND Decision p ursuant to Section 6.3(b ) within the applicable time periods under Section 3.5, or ( c ) [ † ] days after submission of such IND to the Regulatory Authority, if at such time the Regulator y Authority has taken no action with respect to such IND . ” 3 . IND ACCEPTANCE IN SCN8A 3.1 No [COMPANY] Negative IND Decision notification sh all be required under Section 6.3(b ) for this Parti al IND Acceptance