Common use of Regulatory Authority Inspection Clause in Contracts

Regulatory Authority Inspection. (i) If a Regulatory Authority in or outside the Territory desires to conduct an inspection or audit of Syndax’s facility or a facility under contract with Syndax with regard to the Product, Syndax shall cooperate and, if applicable, cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. If Syndax, rather than KHK, receives the inspection or audit observations of such Regulatory Authority in the Territory, Syndax shall promptly provide a copy of such observations to KHK. Syndax (and/or its contractor) shall prepare the response to any such observations, but the submission of the response to the applicable Regulatory Authority shall be subject to KHK’s review or comments, which Syndax shall consider in good faith. Syndax agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable Law. (ii) If a Regulatory Authority in or outside the Territory desires to conduct an inspection or audit of KHK’s facility or a facility under contract with KHK with regard to the Product, KHK shall cooperate and, if applicable, cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. If KHK rather than Syndax, receives the inspection or audit observations of such Regulatory Authority outside the Territory, KHK shall promptly provide a copy of such observations to Syndax. KHK shall prepare the response to any such observations, but the submission of the response to the applicable Regulatory Authority shall be subject to Syndax’s review or comments, which KHK shall consider in good faith. KHK agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable Law.

Regulatory Authority Inspection. (i) If a Regulatory Authority in NASTECH hereby agrees to advise P&GP [***] of any proposed or outside the Territory desires unannounced visit or inspection by any governmental authority, including, without limitation, any REGULATORY AUTHORITY or any environmental regulatory authority and agrees to conduct an inform P&GP if such visit or inspection or audit of Syndax’s facility or a facility under contract with Syndax with regard is related to the Product, Syndax shall cooperate andPRODUCT or its MANUFACTURE. NASTECH agrees, if applicablesuch visit or inspection is related to the PRODUCT or its MANUFACTURE, cause the contract facility to cooperate with such Regulatory Authority permit one or more qualified representative(s) of P&GP to be present if requested by P&GP. If P&GP is not present during such a visit or inspection, and such visit or inspection is related to the PRODUCT or audit. If Syndaxits MANUFACTURE, rather than KHK, receives the inspection or audit observations of such Regulatory Authority in the Territory, Syndax NASTECH shall promptly provide NASTECH's summary report of the results of the inspection to P&GP in English. NASTECH shall [***] furnish P&GP English summaries of all REGULATORY AUTHORITY reports, documents or correspondence with respect to any REGULATORY AUTHORITY requests or inspections of the FACILITY if such reports, documents or correspondence are related to the PRODUCT or its MANUFACTURE, as well as a copy of each such observations report, document or correspondence in English. The Parties will cooperate in the development and review of responses that are required by any REGULATORY AGENCY and relating to KHKthe MANUFACTURE of PRODUCT prior to submission to the regulatory agency. Syndax (and/or its contractor) Nothing contained within this article shall prepare restrict the response right of either party to make a timely report to any REGULATORY AGENCY or take action that it deems to be appropriate or required by APPLICABLE LAW. NASTECH shall without delay notify P&GP of any [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] REGULATORY AGENCY request for samples of PRODUCT or PRODUCT MANUFACTURING lot records and will not provide such observations, but the submission of the response material until such notification is made to the applicable Regulatory Authority shall be subject to KHK’s review or comments, which Syndax shall consider in good faith. Syndax agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable LawP&GP. (ii) If a Regulatory Authority in or outside the Territory desires to conduct an inspection or audit of KHK’s facility or a facility under contract with KHK with regard to the Product, KHK shall cooperate and, if applicable, cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. If KHK rather than Syndax, receives the inspection or audit observations of such Regulatory Authority outside the Territory, KHK shall promptly provide a copy of such observations to Syndax. KHK shall prepare the response to any such observations, but the submission of the response to the applicable Regulatory Authority shall be subject to Syndax’s review or comments, which KHK shall consider in good faith. KHK agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable Law.

Regulatory Authority Inspection. SURMODICS hereby agrees to advise MERCK promptly (iand, in any event, within [*]) If of any proposed or unannounced visit or inspection by any authorized agent of a governmental authority, including any Regulatory Authority in or outside the Territory desires any environmental regulatory authority, to conduct a Facility (whether owned by SURMODICS, an inspection or audit of Syndax’s facility Affiliate or a facility under contract with Syndax with regard Contract Manufacturer) where such visit or inspection is specifically related to the Product or its Manufacture (a “Product-Related Inspection”). SURMODICS agrees to permit (and SURMODICS shall cause its Contract Manufacturers to permit), Syndax shall cooperate andto the extent reasonably practical, one or more qualified representative(s) of MERCK to be present during a Product-Related Inspection if applicable, cause the contract facility to cooperate with such Regulatory Authority during such inspection or auditrequested by MERCK. If SyndaxMERCK is not present during a Product-Related Inspection, rather than KHK, receives the inspection or audit observations of such Regulatory Authority in the Territory, Syndax SURMODICS shall promptly provide a copy summary report of such observations the results of the Product-Related inspection to KHKMERCK in English. Syndax SURMODICS shall promptly (and/or its contractorand, in any event, within [*]) shall prepare the response furnish MERCK English summaries of all reports, documents or correspondence with respect to any Regulatory Authority requests or inspections of a Facility if such observationsreports, but the submission of the response documents or correspondence are related to the applicable Regulatory Authority shall be subject to KHK’s review Product or commentsits Manufacture, which Syndax shall consider in good faith. Syndax agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable Law. (ii) If a Regulatory Authority in or outside the Territory desires to conduct an inspection or audit of KHK’s facility or a facility under contract with KHK with regard to the Product, KHK shall cooperate and, if applicable, cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. If KHK rather than Syndax, receives the inspection or audit observations of such Regulatory Authority outside the Territory, KHK shall promptly provide as well as a copy of each such observations report, document or correspondence in English. The Parties will cooperate in the development and review of responses that are required to Syndax. KHK shall prepare the response be submitted to any such observations, but the submission of the response Regulatory Authority relating to the Manufacture of Product prior to submission to the Regulatory Authority. Nothing contained within this Section 8.3 shall restrict the right of either Party to make a timely report of such matter to any Regulatory Agency or take other action that it deems to be appropriate or required by applicable law or regulation. SURMODICS shall promptly notify MERCK of any Regulatory Authority shall be subject request for samples of Product or Manufacturing batch records and will not provide such material until such notification is made to Syndax’s review or comments, which KHK shall consider in good faith. KHK agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable LawMERCK.