Common use of Governmental Inspections and Inquiries Clause in Contracts

Governmental Inspections and Inquiries. Kyowa Kirin will advise Reata promptly, but in no event later than [***] days after Kyowa Kirin’s receipt of notice thereof, of any planned Regulatory Authority visit to the portion of the facilities of Kyowa Kirin or its Affiliates where Licensed Product is stored or handled or any material written inquiries by a Regulatory Authority concerning such facilities, the procedures of Kyowa Kirin or its Affiliates for the storage or handling of Licensed Products, or the Commercialization of Licensed Product in the Territory. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. If the Regulatory Authority makes an unannounced or unplanned visit, or if Kyowa Kirin does not have at least [***] days notice of the visit, Kyowa Kirin will inform Reata of the visit as soon as reasonably practicable, but in no event later than [***] Business Days after Kyowa Kirin obtains actual knowledge of the visit. Kyowa Kirin will inform Reata, as soon as practicable, regarding the purpose and result of such visit or inquiry, and will provide to Reata copies of any minutes of the inspection generated by Kyowa Kirin (in English if available, without any obligation to translate) promptly following such inspection and any report or correspondence (in English if available, without any obligation to translate) provided by Kyowa Kirin, or any Affiliate, as the case may be, to the Regulatory Authority or issued by or provided by the Regulatory Authority to Kyowa Kirin, or any Affiliate, as the case may be, in connection with such visit or inquiry. If English translations of these materials are not available, then Kyowa Kirin will advise Reata of the material aspects of such minutes and correspondence at the JSC meetings.

Appears in 2 contracts

Samples: Supply Agreement (Reata Pharmaceuticals Inc), Supply Agreement (Reata Pharmaceuticals Inc)

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Governmental Inspections and Inquiries. Kyowa Kirin will advise Reata promptly, but in no event later than [***] days after Kyowa Kirin’s receipt of notice thereof, of any planned Regulatory Authority visit to the portion of the facilities of Kyowa Kirin or its Affiliates where Licensed Product is stored or handled or any material written inquiries by a Regulatory Authority concerning such facilities, the procedures of Kyowa Kirin or its Affiliates for the storage or handling of Licensed Products, or the Commercialization of Licensed Product in the Territory. Specific terms in this exhibit Exhibit have been redacted because confidential treatment for those such terms has been requestedare both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this exhibit Exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. If the Regulatory Authority makes an unannounced or unplanned visit, or if Kyowa Kirin does not have at least [***] days notice of the visit, Kyowa Kirin will inform Reata of the visit as soon as reasonably practicable, but in no event later than [***] Business Days after Kyowa Kirin obtains actual knowledge of the visit. Kyowa Kirin will inform ReataXxxxx, as soon as practicable, regarding the purpose and result of such visit or inquiry, and will provide to Reata copies of any minutes of the inspection generated by Kyowa Kirin (in English if available, without any obligation to translate) promptly following such inspection and any report or correspondence (in English if available, without any obligation to translate) provided by Kyowa Kirin, or any Affiliate, as the case may be, to the Regulatory Authority or issued by or provided by the Regulatory Authority to Kyowa Kirin, or any Affiliate, as the case may be, in connection with such visit or inquiry. If English translations of these materials are not available, then Kyowa Kirin will advise Reata of the material aspects of such minutes and correspondence at the JSC meetings.

Appears in 1 contract

Samples: Exclusive License and Supply Agreement (Reata Pharmaceuticals Inc)

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Governmental Inspections and Inquiries. Kyowa Kirin Teijin will advise Reata Versartis promptly, but in no event later than [***[ * ] days Business Days after Kyowa KirinTeijin’s receipt of notice thereof, of (i) any planned Regulatory Authority visit to the portion of the facilities of Kyowa Kirin Teijin or its Affiliates where any Licensed Product is stored or handled handled, or (ii) any material written inquiries by a Regulatory Authority concerning such facilities, the procedures of Kyowa Kirin Teijin’s or its Affiliates for Affiliates’ procedures with respect to the storage or handling of Licensed Products, or the Commercialization of Licensed Product Products in the Territory. Specific terms in this exhibit have been redacted because confidential treatment for those terms has been requested. These redacted terms have been marked in this exhibit with three asterisks [***]. An unredacted version of this exhibit has been separately filed with the Securities and Exchange Commission. If the a Regulatory Authority makes an unannounced or unplanned visit, or if Kyowa Kirin does not have at least [***] days notice of the visit, Kyowa Kirin Teijin will inform Reata Versartis of the visit as soon as reasonably practicable, but in no event later than [***[ * ] Business Days after Kyowa Kirin Teijin obtains actual knowledge of the visit. Kyowa Kirin Teijin will inform ReataVersartis, as soon as practicable, regarding the purpose and result of such visit or inquiry, and [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. will provide to Reata Versartis copies of any minutes of the inspection generated by Kyowa Kirin Teijin (in English if available, without any obligation to translateEnglish) promptly following such inspection inspection, and any report or correspondence (in English if available, without any obligation to translateEnglish) provided by Kyowa Kirin, Teijin or any its Affiliate, as the case may be, to the such Regulatory Authority or issued by or provided by the such Regulatory Authority to Kyowa Kirin, Teijin or any its Affiliate, as the case may be, in connection with such visit or inquiry. If English translations of these materials are not available, then Kyowa Kirin Teijin will advise Reata Versartis of the material aspects of such minutes and correspondence at the next regularly-scheduled JSC meetingsmeeting.

Appears in 1 contract

Samples: Exclusive License and Supply Agreement (Versartis, Inc.)

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