Common use of ▇▇▇▇▇▇ Responsibility Clause in Contracts

▇▇▇▇▇▇ Responsibility. (i) Until the FIN-524 First Phase II Completion or FIN-525 First Phase II Completion, as applicable with respect to a Development Program (provided, if Takeda exercises a Phase II Development Option for a Licensed Product, until the completion of Phase I Clinical Trials in the U.S. of such Licensed Product), ▇▇▇▇▇ shall be solely responsible for taking all actions and conducting all communications with U.S. and each appropriate foreign Regulatory Authority(ies) required by Applicable Laws in respect of each Regulatory Filing in support of obtaining Regulatory Approval in accordance with the Development Plan and decision made at the Joint Development Committee and/or Joint Steering Committee. (ii) ▇▇▇▇▇ shall provide Takeda with a copy (which may be wholly or partly in electronic form) of all Regulatory Filings with respect to Licensed Product. ▇▇▇▇▇ shall provide Takeda with reasonable advance notice of any scheduled meeting with a Regulatory Authority relating to Development, such BLA and/or regulatory inspection (including, without limitation, GMP and PV inspection), and Takeda shall have the right, if and to the extent permitted by the relevant Regulatory Authority, to observe and to participate in any such meeting. ▇▇▇▇▇ shall promptly furnish Takeda with copies of all material correspondence, minutes of material meetings with any Regulatory Authority or any result of regulatory inspection in each case relating to the Licensed Product. (iii) Takeda shall assist ▇▇▇▇▇ as reasonably necessary to review its filings, data, documentation, responses to Regulatory Authority questionnaires or queries regarding clinical data, and advise and support of any necessary inspections. Notwithstanding the foregoing, ▇▇▇▇▇ shall be primarily responsible for taking all actions and conducting all communications with each appropriate foreign Regulatory Authority required by Applicable Laws in respect of BLA.