Common use of Preparation of Regulatory Materials Clause in Contracts

Preparation of Regulatory Materials. After the Effective Date (or, as applicable, the IND Date), the Lead Regulatory Party shall have the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials, including the Product INDs, the Product Regulatory Approvals, and other submissions, and to conduct communications with the FDA, for the relevant Products in the applicable indication in the Territory or applicable portion thereof, except in the case of Licensed [***] Products from the Effective Date until expiration of the [***] Option Term, during which time Takeda shall hold the IND and Ultragenyx (i.e., the Lead Regulatory Party) shall receive a right of reference from Takeda. Except with respect to Licensed [***] Products from the Effective Date until expiration of the [***] Option Term, all Product INDs and Product Regulatory Approvals generated after the Effective Date, including any supplements or amendments to those Product INDs and Product Regulatory Approvals in existence as of the Effective Date, with respect to such Products in the

Preparation of Regulatory Materials. (a) After the Effective Date (or, as applicable, the IND Date), the Lead Regulatory Party shall have the sole right and responsibility, and shall exercise Commercially Reasonable Efforts, to prepare, obtain, and maintain, as applicable, the Regulatory Materials, including the Product INDs, the Product Regulatory Approvals, and other submissions, and to conduct communications with the FDA, for the relevant Products in the applicable indication in the Territory or applicable portion thereof, except in the case of Licensed [***] Products from the Effective Date until expiration of the [***] Option Term, during which time Takeda shall hold the IND and Ultragenyx (i.e., the Lead Regulatory Party) shall receive a right of reference from Takeda. Except with respect to Licensed [***] Products from the Effective Date until expiration of the [***] Option Term, all Product INDs and Product Regulatory Approvals generated after the Effective Date, including any supplements or amendments to those Product INDs and Product Regulatory Approvals in existence as of the Effective Date, with respect to such Products in the