Common use of Regulatory Documentation Clause in Contracts

Regulatory Documentation. Subject to Section 3.1(g), as soon as practicably possible after the Effective Date but in no event later than [***] after the Effective Date, Merck will transfer and assign to Urovant all Regulatory Documentation in Merck’s possession or control (including, Subject to Section 8.3, the transfer to Urovant of a database that contains all relevant information regarding adverse events that have been observed during any clinical trials or studies with respect to the Compound prior to the Effective Date). Urovant shall, at its own costs and expenses, make and prepare any and all other regulatory documentation necessary for submission to the applicable Governmental Agency in the Territory for the Regulatory Approvals with the goal of obtaining at least one Marketing Authorization in the Territory. Upon completion of the activities outlined in Section 3.1(g), Merck shall be under no obligation to provide Urovant with regulatory assistance in fulfilling the necessary regulatory activities to achieve Marketing Authorization in the Territory. Notwithstanding anything in this Agreement to the contrary, during the Term and upon reasonable advance request by Urovant, Merck agrees, to the extent readily available, to provide, or otherwise provide access to Urovant with respect to, all raw data underlying or referenced in, any Regulatory Documentation, to the extent not provided as part of the transfer contemplated under Section 3.1(g) and this Section 4.4; provided, however, that if Merck is not able under Applicable Laws to provide access to Urovant to such raw data, and if such data is required or requested by any Governmental Agency, Merck shall provide such raw data to such Governmental Agency, upon request of Urovant; provided, further, that, to the extent available, Merck shall provide such raw data as-is, and is under no obligation to do any further analysis or computation with such data.