definiens: shall mean ( i ) provision of information regarding developmen t and regulatory activities with respect to the Pro ducts and Tracon Products except for information exchanged th rough the JDC, ( ii ) provision of any safety information with res pect to the Products and Tracon Products at the req uest of a Party other than the information exchanged under a safety data exchange agreement entered into by the Parties pursuant to Section 3.2(c ), ( iii ) provision of regulatory support with respect to the Products and Tracon Products including, wit hout limitation, review of the regulatory documents ( IND, BLA etc . ), participation in meetings with Regulat ory Authorities ( including the FDA ) and responding to i nquiries from any Regulatory Authority, and ( iv ) provision of services related to coordinatio n ( including scheduling of activities, shipping act ivities and negotiation of agreements ) with Tracon ’s contract m anufacturer . For the purpose of provision of this c lause ( iv ), Tracon shall provide Santen access to Tracon employees and consultants, to the extent such consu ltants are available, and shall use reasonable efforts to enable Santen to have access to employees and consu ltants of its contractors ( including its contract manufact urers ), as reasonably necessary to assist in connec tion with the shipping ( including necessary support ) of reage nt and TRC105 sample supply for non - clinical / CMC purposes upon Santen ’s request and prior written co nsent, provided however that, shall exclude the Ser vice by CRO MSA