Audit of Affymax Sample Clauses

Audit of Affymax. (i) If a Regulatory Authority in the U.S. desires to conduct an inspection or audit of Affymax's facility, or a facility under contract with Affymax, with regard to the Product or the Bulk API in or for the U.S., Affymax shall promptly notify Takeda and permit and cooperate with such inspection or audit, and shall cause the contract facility to permit and cooperate with such Regulatory Authority during such inspection or audit. Takeda shall have the right to have a representative observe such inspection or audit and Takeda shall, if requested by Affymax, assist Affymax in preparing for, facilitating or enabling such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which Affymax shall immediately provide to Takeda), Affymax shall prepare a draft response to any such observations in English, in consultation with Takeda, and Affymax shall prepare and file the final response with such Regulatory Authority, and shall provide a copy of such response to Takeda.
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