Regulatory Notifications Sample Clauses
Regulatory Notifications. Codexis shall notify Customer immediately, and in no event later than [***], after receiving any contact or communication from any Regulatory Authority that in any way relates to the Products. Codexis shall advise Customer no later than the next day that is not a Saturday, Sunday, or federal or state holiday if an authorized agent of any Agencies or any other regulatory body plans to visit the Facility solely in relation to the Products for Customer, and/or makes an inquiry regarding manufacturing of Codexis Enzymes for use in processing Products for Customer or regarding any part of the Facility that is used in manufacturing of Codexis Enzymes for use in processing of Products for Customer. Customer shall have the right to be present at any visit relating to Products for Customer and to review in advance and comment on any response to the communication or investigation submitted by Codexis. Codexis shall cooperate fully with such Regulatory Authority and with Customer in providing the information needed for any such communication. Codexis shall provide to Customer copies of any document delivered by such Regulatory Authority or regulatory body as a result of such visit. If an authorized agent of any Regulatory Authority or any other regulatory body visits the Facility in connection with another product or another part of the Facility and such visit results in a finding or other action that could materially and adversely affect Codexis’ production of Codexis Enzyme under this Agreement, then Codexis shall notify Customer as soon as practicable and shall provide Customer with information concerning Codexis’ response to such finding or action. Customer shall retain the right to amend Codexis’ response to a Regulatory Authority solely in relation to the Product.
Regulatory Notifications. Codexis shall notify Pfizer immediately, and in no event later than [***], after receiving any contact or communication from any governmental, administrative or Regulatory Authority that in any way relates to the Codexis Enzyme, Intermediate or the Product. Codexis shall advise Pfizer no later than the next day that is not a Saturday, Sunday, or federal or state holiday if an authorized agent of any governmental, administrative or Regulatory Authority or any other regulatory body plans to visit the Facility solely in relation to the Codexis Enzyme, Intermediate or Product for Pfizer, and/or makes an inquiry regarding manufacturing of Codexis Enzyme for use in manufacturing Intermediate for Pfizer or regarding any part of the Facility that is used in manufacturing of Codexis Enzyme for use in manufacturing of Intermediate for Pfizer. Pfizer and Pfizer Affiliates shall have the right to be present at any visit relating to Codexis Enzyme, Intermediate and Product and to review in advance and comment on any response to the communication or investigation submitted by Codexis (and Codexis shall endeavor in good faith to satisfactorily address and incorporate all Pfizer comments prior to submission). Codexis shall cooperate fully with such Regulatory Authority and with Pfizer and its Affiliates in providing the information needed for any such communication. Codexis shall provide to Pfizer copies of any document delivered by such Regulatory Authority or regulatory body as a result of such visit. If an authorized agent of any Regulatory Authority or any other regulatory body visits the Facility in connection with another product or another part of the Facility and such visit results in a finding or other action that could materially and adversely affect Codexis’ performance of the Services under this Agreement, then Codexis shall notify Pfizer as soon as practicable and, within [***], shall provide Pfizer with information concerning Codexis’ response to such finding or action.
Regulatory Notifications. Condition