Common use of Regulatory Obligations Clause in Contracts

Regulatory Obligations. Customer shall be solely responsible for preparation and submission of applications to Agencies regarding the Product. Customer will advise Codexis of document requirements in support of such applications by Customer. Codexis will, at Customer’s expense at Codexis’ then-current rates agreed upon by the Parties, use its commercially reasonable efforts to provide documents and additional information needed for such applications, and to cooperate with and assist Customer in preparation and submission of such applications to the FDA (and other Agencies, as appropriate). All such applications to Agencies and related filings by Customer shall be the sole and exclusive property of Customer, as applicable. Customer shall be solely responsible for all contacts and communications with any Agencies with respect to all matters relating to the Product. At the request of Customer, Codexis shall make appropriate personnel reasonably available for meetings with Agencies related to manufacturing of Codexis Enzymes and the related processing of the Product.

Regulatory Obligations. Customer shall be solely responsible for preparation and submission of applications to Agencies regarding the Product. Customer will advise Codexis of document requirements in support of such applications by Customer. Codexis will, at Customer’s expense at Codexis’ then-current rates agreed upon by the Parties, use its commercially reasonable efforts to provide documents and additional information needed for such applications, and to cooperate with and assist Customer in preparation and submission of such applications to the FDA (and other Agencies, as appropriate). All such applications to Agencies and related filings by Customer shall be the sole and exclusive property of Customer, as applicable. Customer shall be solely responsible for all contacts and communications with any Agencies with respect to all matters relating to the Product. At the request of Customer, Codexis shall make appropriate personnel reasonably available for meetings with Agencies related to manufacturing of Codexis Enzymes and the related processing of the Product.contacts