Unless otherwise agreed upon by the Parties, after the Regulatory Transfer Date, Takeda shall be the lead party for all regulatory-related activities with respect to such Products and TBIL shall not communicate or correspond with any Regulatory Authority with respect to such Products without the prior written consent of Takeda unless such communication or correspondence is required to comply with Applicable Laws, in which case TBIL shall, to the extent practicable, notify Takeda and obtain Takeda’s written consent prior to engaging in such communication or submitting such correspondence; provided that , upon TBIL’s request, Takeda shall: (i) provide TBIL with drafts of all material Regulatory Materials reasonably in advance of submission to a Regulatory Authority for TBIL’s review and comment and  reasonably consider incorporating TBIL’s reasonable comments in connection therewith, (ii) provide TBIL with a copy, in electronic form if reasonably practicable, of all material Regulatory Materials submitted to or received from a Regulatory Authority, promptly, but in no event later than [***] Business Days after receipt or submission thereof, and (iii) notify TBIL reasonably prior to any material meetings and material conferences related to the Products with Regulatory Authorities and unless precluded by Applicable Law, upon TBIL’s request, TBIL may attend and observe (and, upon Takeda’s request or written consent, which may be withheld or granted at Takeda’s sole discretion, participate in) such meetings; provided that , unless otherwise agreed to by Takeda, no more than [***] of TBIL’s employees or its designees may attend a meeting with the FDA and no more than [***] of TBIL’s employees or its designees may attend a meeting with any other Regulatory Authority, and (iv) upon TBIL’s request, provide TBIL with all reports and minutes from all such material meetings and conferences.