definiens: ( as defined below ), as determined by [COMPANY] ], [COMPANY] shall assign or cause to be assigned to [COMPANY] all Regulatory Filings for the Compound in the Territory ; provided, however, that, [ prior to the assignment of any such Regulatory Filing, ] [COMPANY] shall maintain [ such Regulatory Filings at its expense and shall take all reasonable actions to make available to [COMPANY] the benefits of such Regulatory Filings to the extent required by [COMPANY] in connection with its activities under this Agreement ] . Notwithstanding the foregoing, it is understood that [COMPANY] may [ retain the existing INDs and/or file additional INDs, to the extent necessary to conduct the Phase I trials being conducted by [COMPANY] as of the Effective Date on behalf of Astellas ] and/or [ any Clinical Studies and Activities which [COMPANY] is required to conduct pursuant to Section 4.3 or is otherwise permitted to conduct pursuant to Section 2.3(b ) ; ] provided that [ all such INDs shall be assigned to [COMPANY] by no later than the date on which the with the FDA occurs . ] For such purposes, [ the with the FDA shall mean a meeting with FDA, ] at which [COMPANY] [ is present as provided in Section 4.7(a)(ii ), to discuss the expectations of the FDA regarding, and the timing for, the NDA for the RLS Indication ]