Common use of Regulatory Authority Inspection Clause in Contracts

Regulatory Authority Inspection. NASTECH hereby agrees to advise MERCK [***] of any proposed or unannounced visit or inspection by any governmental authority, including, without limitation, any REGULATORY AUTHORITY or any environmental regulatory authority and agrees to inform Merck if such visit or inspection is related to the PRODUCT or its MANUFACTURE. NASTECH agrees, if such visit or inspection is related to the PRODUCT or its MANUFACTURE, to permit one or more qualified 16 <PAGE> [*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.] representative(s) of MERCK to be present if requested by MERCK. If MERCK is not present during such a visit or inspection, and such visit or inspection is related to the PRODUCT or its MANUFACTURE, NASTECH shall promptly provide a summary report of the results of the inspection to MERCK in English. NASTECH shall [***] furnish MERCK English summaries of all 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 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 the MANUFACTURE of PRODUCT prior to submission to the regulatory agency. Nothing contained within this article 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. NASTECH shall without delay notify MERCK of any REGULATORY AGENCY request for samples of PRODUCT or PRODUCT MANUFACTURING batch records and will not provide such material until such notification is made to MERCK. 8.4

Regulatory Authority Inspection. NASTECH hereby agrees to advise MERCK P&GP [***] of any proposed or unannounced visit or inspection by any governmental authority, including, without limitation, any REGULATORY AUTHORITY or any environmental regulatory authority and agrees to inform Merck P&GP if such visit or inspection is related to the PRODUCT or its MANUFACTURE. NASTECH agrees, if such visit or inspection is related to the PRODUCT or its MANUFACTURE, to permit one or more qualified 16 <PAGE> [*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.] representative(s) of MERCK P&GP to be present if requested by MERCKP&GP. If MERCK P&GP is not present during such a visit or inspection, and such visit or inspection is related to the PRODUCT or its MANUFACTURE, NASTECH shall promptly provide a NASTECH's summary report of the results of the inspection to MERCK P&GP in English. NASTECH shall [***] furnish MERCK 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 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 the MANUFACTURE of PRODUCT prior to submission to the regulatory agency. Nothing contained within this article shall restrict the right of either Party 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. NASTECH shall without delay notify MERCK 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 batch lot records and will not provide such material until such notification is made to MERCK. 8.4P&GP.

Regulatory Authority Inspection. NASTECH hereby agrees to advise MERCK [***] of any proposed or unannounced visit or inspection by any governmental authority, including, without limitation, any REGULATORY AUTHORITY or any environmental regulatory authority and agrees to inform Merck if such visit or inspection is related to the PRODUCT or its MANUFACTURE. NASTECH agrees, if such visit or inspection is related to the PRODUCT or its MANUFACTURE, to permit one or more qualified 16 <PAGE> [*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.] representative(s) of MERCK to be present if requested by MERCK. If MERCK is not present during such a visit or inspection, and such visit or inspection is related to the PRODUCT or its MANUFACTURE, NASTECH shall promptly provide a summary report of the results of the inspection to MERCK in English. NASTECH shall [***] furnish MERCK English summaries of all 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 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 the MANUFACTURE of PRODUCT prior to submission to the regulatory agency. Nothing contained within this article 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. NASTECH shall without delay notify MERCK of any REGULATORY AGENCY request for samples of PRODUCT or PRODUCT MANUFACTURING batch records and will not provide such material until such notification is made to MERCK. 8.4.

Regulatory Authority Inspection. NASTECH SURMODICS hereby agrees to advise MERCK promptly (and, in any event, within [***] ]) of any proposed or unannounced visit or inspection by any authorized agent of a governmental authority, including, without limitation, including any REGULATORY AUTHORITY Regulatory Authority or any environmental regulatory authority and agrees authority, to inform Merck if a Facility (whether owned by SURMODICS, an Affiliate or a Contract Manufacturer) where such visit or inspection is specifically related to the PRODUCT Product or its MANUFACTUREManufacture (a “Product-Related Inspection”). NASTECH agreesSURMODICS agrees to permit (and SURMODICS shall cause its Contract Manufacturers to permit), if such visit or inspection is related to the PRODUCT or its MANUFACTUREextent reasonably practical, to permit one or more qualified 16 <PAGE> [*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.] representative(s) of MERCK to be present during a Product-Related Inspection if requested by MERCK. If MERCK is not present during such a visit or inspectionProduct-Related Inspection, and such visit or inspection is related to the PRODUCT or its MANUFACTURE, NASTECH SURMODICS shall promptly provide a summary report of the results of the Product-Related inspection to MERCK in English. NASTECH SURMODICS shall promptly (and, in any event, within [***] ]) furnish MERCK English summaries of all reports, documents or correspondence with respect to any REGULATORY AUTHORITY Regulatory Authority requests or inspections of the FACILITY a Facility if such reports, documents or correspondence are related to the PRODUCT Product or its MANUFACTUREManufacture, as well as a copy of each such report, document or correspondence in English. The Parties will cooperate in the development and review of responses that are required by to be submitted to any REGULATORY AGENCY and Regulatory Authority relating to the MANUFACTURE Manufacture of PRODUCT Product prior to submission to the regulatory agencyRegulatory Authority. Nothing contained within this article Section 8.3 shall restrict the right of either Party to make a timely report of such matter to any REGULATORY AGENCY Regulatory Agency or take other action that it deems to be appropriate or required by APPLICABLE LAWapplicable law or regulation. NASTECH SURMODICS shall without delay promptly notify MERCK of any REGULATORY AGENCY Regulatory Authority request for samples of PRODUCT Product or PRODUCT MANUFACTURING Manufacturing batch records and will not provide such material until such notification is made to MERCK. 8.4.