Common use of Communications with FDA Clause in Contracts

Communications with FDA. All communications with the FDA concerning the Product shall be the sole responsibility of Relypsa and, unless required by Applicable Law, shall be initiated solely by Relypsa. Sanofi shall provide to Relypsa prompt notice if the FDA or other governmental authority in the Territory contacts Sanofi regarding the Product. Commencing upon the date that the label for the Product has been established by the FDA, Relypsa shall provide to Sanofi [***] notice of [***] with the FDA or other governmental authority in the Territory with respect to the Product which would [***] or is [***]. Sanofi shall provide reasonable assistance, at [***], to Relypsa with respect to any such communications or interactions with the FDA described in this Section 5.6 to the extent deemed necessary by Relypsa.

Communications with FDA. All communications with the FDA concerning the Product shall be the sole responsibility of Relypsa and, unless required by Applicable Law, shall be initiated solely by Relypsa. Sanofi shall provide to Relypsa prompt notice if the FDA or other governmental authority in the Territory contacts Sanofi regarding the Product. Commencing upon the date that the label for the Product has been established by the FDA, Relypsa shall provide to Sanofi [***] notice of [***] with the FDA or other governmental authority in the Territory with respect to the Product which would [***] or is [***]. Sanofi shall provide reasonable assistance, at [***], to Relypsa with respect to any such communications or interactions with the FDA described in this Section 5.6 0 to the extent deemed necessary by Relypsa.