Common use of Oral Communication Initiated by Regulatory Authority Clause in Contracts

Oral Communication Initiated by Regulatory Authority. If the FDA or other Regulatory Authority initiates any unscheduled oral communication with the BLA Party directly regarding the Non-BLA Party’s products, or which could impact the Non-BLA Party’s products, BLA Party shall have the right to respond to such communication to the extent reasonably necessary or appropriate under the circumstances; provided, however, that (i) BLA Party shall use reasonable efforts to limit the communications regarding the Non-BLA Party’s products that are conducted without the participation of Non-BLA Party; (ii) promptly thereafter, the BLA Party shall provide Non-BLA Party with written notice thereof in reasonably specific detail describing the communications regarding Non-BLA Party’s products; and (iii) the BLA Party promptly shall provide Non-BLA Party with copies of all minutes and other materials resulting therefrom. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.

Oral Communication Initiated by Regulatory Authority. If the FDA or other Regulatory Authority initiates any unscheduled oral communication with the BLA Party directly regarding the Non-BLA Party’s products, or which could impact the Non-BLA Party’s products, BLA Party shall have the right to respond to such communication to the extent reasonably necessary or appropriate under the circumstances; provided, however, that (i) BLA Party shall use reasonable efforts to limit the communications regarding the Non-BLA Party’s products that are conducted without the participation of Non-BLA Party; (ii) promptly thereafter, the BLA Party shall provide the Non-BLA Party with written notice thereof in reasonably specific detail describing the communications regarding Non-BLA Party’s products; and (iii) the BLA Party promptly shall provide Non-BLA Party Party’s with copies of all minutes and other materials resulting therefrom. [*****] Confidential portions of this document have been redacted and filed separately with the Securities and Exchange Commission.