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. (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.
Regulatory Authority Inspection. (a) Inspections of Oncoheroes. Oncoheroes shall immediately notify Allarity as soon as Oncoheroes becomes aware of any Regulatory Authority inspections relating to any Product in the Licensed Field in the Territory. Allarity may be present at any such inspections and Oncoheroes shall provide Allarity the opportunity to review and comment on any responses that may be required. If Oncoheroes does not receive prior notice of any such inspection, Oncoheroes shall notify Allarity as soon as practicable after such inspection and shall provide Allarity with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection.
Regulatory Authority Inspection. (a) Inspections of Verrica. Verrica shall immediately notify Lytix as soon as Verrica becomes aware of any Regulatory Authority inspections relating to any Product in the Licensed Field in the Territory. Lytix may be present at any such inspections and Verrica shall provide Lytix the opportunity to review and comment on any responses that may be required. If Verrica does not receive prior notice of any such inspection, Verrica shall notify Lytix as soon as practicable after such inspection and shall provide Lytix with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
Regulatory Authority Inspection. Healeon will promptly advise Suneva if an authorized agent of any Regulatory Authority visits the Facility and requests or requires information or changes that directly pertain to Healeon’s activities under this Agreement. At Suneva’s request, Healeon will allow a representative of Suneva to be present during any such inspection, investigation or inquiry; provided, however, that Suneva’s on site representative will not be part of the face-to-face team during any portion of the inspection, investigation or inquiry that does not relate specifically to Healeon’s activities under this Agreement.
Regulatory Authority Inspection. MILTENYI will permit inspections of MILTENYI's facilities by regulatory bodies of all jurisdictions (such as the FDA and equivalent European regulatory authorities) ("Regulatory Authority Inspection") and will respond to any notices or requests for information by regulatory authorities, for any import or export license, registration or pending registration for manufacturing of Cell Separation Kits during the term of this Agreement.
Regulatory Authority Inspection. (a) Inspections of Cxxxxx. Cxxxxx shall immediately notify CSPC as soon as Cxxxxx becomes aware of any Regulatory Authority inspections relating to any Licensed Product in the Field in the Collaborative Territory. CSPC may be present at any such inspections to the extent related to the CSPC CMC Activities and Cxxxxx shall provide CSPC the opportunity to review and comment on any responses that may be required to the extent practically possible. If Cxxxxx does not receive prior notice of any such inspection, Cxxxxx shall notify CSPC as soon as practicable after such inspection and shall provide CSPC with copies of all relevant materials, including notes, correspondence, statements, forms, and records received or generated pursuant to any such inspection.
Regulatory Authority Inspection. Histogen will promptly advise Suneva if an authorized agent of any Regulatory Authority visits the Facility and requests or requires information or changes that directly pertain to Histogen’s activities under this Agreement. At Suneva’s request, Histogen will allow a representative of Suneva to be present during any such inspection, investigation or inquiry; provided, however, that Suneva’s on site representative will not be part of the face-to-face team during any portion of the inspection, investigation or inquiry that does not relate specifically to Histogen’s activities under this Agreement.
Regulatory Authority Inspection. IDT will permit Regulatory Authorities to conduct inspections relating to the Product and will cooperate fully in connection with such inspections pursuant to applicable provisions of the QAA. With respect to any such Regulatory Authority inspection that relates solely to the Product, IDT will invoice to Valneva a fee equal to [***] and [***]. IDT shall Notify Valneva of the results of the inspection within a reasonable period after receipt of such results.
Regulatory Authority Inspection. Each Party shall promptly notify the other Party in writing within [ * ] inspections by any Regulatory Authority directly related to the Combined Therapy and/or the other Party’s Compound, and within [ * ] regulatory inspection with respect to the other Party’s Compound or Combined Therapy development activities.
