Common use of Inspections and Records Clause in Contracts

Inspections and Records. Upon Kyowa Kirin’s prior written notice, Reata shall, and shall cause its Third Party Manufacturer to, during normal business hours, permit Kyowa Kirin or its designee to audit the facilities, systems and personnel involved in manufacturing Licensed Product supplied to Kyowa Kirin hereunder. Such audits shall occur a maximum of once per [***] period; provided, however that Kyowa Kirin (or its designee) shall have the right to conduct additional audits on an ad hoc basis in the event that a significant defect in the Licensed Product arises and/or a Regulatory Authority requires an audit to be conducted by Kyowa Kirin, provided that Kyowa Kirin uses commercially reasonable efforts to co-ordinate and align any such audit with any audit it undertakes pursuant to the preceding sentence. Reata shall consider in good faith any guidance given by Kyowa Kirin based on such audit in respect of manufacture of Licensed Product for Kyowa Kirin hereunder, however Reata is not obligated to follow or adopt such guidance except to correct departures from GMPs or other failures to comply with Applicable Laws. Reata shall (and shall cause its Third Party Manufacturers to) also permit Regulatory Authorities (and the FDA) to audit the facilities, systems and personnel involved in manufacturing Licensed Product supplied to Kyowa Kirin hereunder and make any corrections or improvements, and take any actions, required as a result of such audit. Reata shall maintain (and shall cause its Third Party Manufacturers to maintain), all records and documents necessary to comply with all Applicable Laws (including GMP) relating to the manufacture of Licensed Products (including all manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the manufacture of Licensed Product), which shall be retained for such period as may be required by Applicable Laws.

Inspections and Records. Upon Kyowa Kirin’s prior written notice, Reata shall, and shall cause its Third Party Manufacturer to, during normal business hours, permit Kyowa Kirin or its designee to audit the facilities, systems and personnel involved in manufacturing Licensed Product supplied to Kyowa Kirin hereunder. Such audits shall occur a maximum of once per [***] period; provided, however that Kyowa Kirin (or its designee) shall have the right to conduct additional audits on an ad hoc basis in the event that a significant defect in the Licensed Product arises and/or a Regulatory Authority requires an audit to be conducted by Kyowa Kirin, provided that Kyowa Kirin uses commercially reasonable efforts to co-ordinate and align any such audit with any audit it undertakes pursuant to the preceding sentence. Reata shall consider in good faith any guidance given by Kyowa Kirin based on such audit in respect of manufacture of Licensed Product for Kyowa Kirin hereunder, however Reata Xxxxx is not obligated to follow or adopt such guidance except to correct departures from GMPs or other failures to comply with Applicable Laws. Reata shall (and shall cause its Third Party Manufacturers to) also permit Regulatory Authorities (and the FDA) to audit the facilities, systems and personnel involved in manufacturing Licensed Product supplied to Kyowa Kirin hereunder and make any corrections or improvements, and take any actions, required as a result of such audit. Reata shall maintain (and shall cause its Third Party Manufacturers to maintain), all records and documents necessary to comply with all Applicable Laws (including GMP) relating to the manufacture of Licensed Products (including all manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the manufacture of Licensed Product), which shall be retained for such period as may be required by Applicable Laws. Specific terms in this Exhibit have been redacted because such terms are 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 with three asterisks [***].

Inspections and Records. Upon Kyowa KirinSandoz’s reasonable prior written notice, Reata Anacor shall, and shall cause its Third Party Manufacturer to, during normal business hours, permit Kyowa Kirin Sandoz or its designee to audit Anacor’s facilities, systems and personnel involved in manufacturing the Product supplied to Sandoz hereunder. All such audits under this Section 7.8 shall occur a maximum of [*****], except that additional audits may be conducted for cause. Anacor shall provide Sandoz with a summary report [*****], to the extent related to supply of the Product for the Territory. In addition, Anacor will use Commercially Reasonable Efforts to cause its Third Party Manufacturers to allow Sandoz to (a) accompany Anacor on Anacor’s for-cause audits, if related to supply of the Product for the Territory, of its Third Party Manufacturers’ facilities, systems and personnel involved in manufacturing Product supplied to Sandoz hereunder and (b) together with Anacor, conduct an audit of the Manufacturing Costs. Anacor shall consider in good faith any guidance given by Sandoz based on any such audit with respect to the manufacture of Product for Sandoz hereunder. Anacor shall (and shall use Commercially Reasonable Efforts to cause its Third Party Manufacturers to) also permit Regulatory Authorities to audit the facilities, systems and personnel involved in manufacturing Licensed Product supplied to Kyowa Kirin hereunder. Such audits shall occur a maximum of once per [***] period; provided, however that Kyowa Kirin (or its designee) shall have the right to conduct additional audits on an ad hoc basis in the event that a significant defect in the Licensed Product arises and/or a Regulatory Authority requires an audit to be conducted by Kyowa Kirin, provided that Kyowa Kirin uses commercially reasonable efforts to co-ordinate and align any such audit with any audit it undertakes pursuant to the preceding sentence. Reata shall consider in good faith any guidance given by Kyowa Kirin based on such audit in respect of manufacture of Licensed Product for Kyowa Kirin hereunder, however Reata is not obligated to follow or adopt such guidance except to correct departures from GMPs or other failures to comply with Applicable Laws. Reata shall (and shall cause its Third Party Manufacturers to) also permit Regulatory Authorities (and the FDA) to audit the facilities, systems and personnel involved in manufacturing Licensed Product supplied to Kyowa Kirin Sandoz hereunder and make any corrections or improvements, and take any actions, required as a result of such audit. Reata Anacor shall maintain (and shall use Commercially Reasonable Efforts to cause its Third Party Manufacturers to maintain), all records and documents necessary to comply with all Applicable Laws (including GMP) relating to the manufacture of Licensed Products the Product (including all manufacturing records, standard operating procedures, equipment log books, batch records, laboratory notebooks and all raw data relating to the manufacture of Licensed Product), which shall be retained for such period as may be required by Applicable Laws.