definiens: shall mean ( i ) provision of information regarding dev elopment and regulatoryactivities with respect to the Products and Tracon Prod ucts except for informationexchanged through the JDC, ( ii ) provision of any safety i nformation with respect tothe Products and Tracon Products at the request of a P arty other than theinformation exchanged under a safety data exchange agr eement entered into bythe Parties pursuant to Section 3.2(c ), ( iii ) provision of regulatory support withrespect to the Products and Tracon Products including, without limitation, review ofthe regulatory documents ( IND, BLA etc . ), participati on in meetings with RegulatoryAuthorities ( including the FDA ) and responding to inqu iries from any RegulatoryAuthority, ( iv ) services in connection with the shipping ( including necessarysupport ) of reagent and TRC105 sample supply for no n - clinical / CMC purposes, and ( v ) services related to coordination ( including sched uling of activities, shippingactivities and negotiation of agreements ) with Tracon ’s contract manufacturer . ” 3