By Otsuka. Prior to execution of the first Quality Agreement, Otsuka shall be entitled to conduct [***]. In addition, if Ionis elects to inspect or audit any facilities of its CMOs with respect to the Manufacture of Licensed Products for the Otsuka Territory, Ionis shall notify Otsuka of such inspection or audit and, [***]. In addition, to the extent permitted under Ionis’ agreement with the applicable CMO and subject to any conditions set forth in such agreement with respect to any inspection or audit (e.g., an obligation to enter into a confidentiality agreement with the applicable CMO), Ionis shall [***]. If Otsuka identifies the need to perform a “for cause” audit of such facilities to address quality or compliance issues related to any Licensed Product Manufactured for the Otsuka Territory (including to address any notice from a Governmental Authority in the Otsuka Territory of noncompliance with Applicable Laws), as well as in connection with the preparation of Regulatory Submissions for the Otsuka Territory and in response to Regulatory Authority requirements in the Otsuka Territory, then Otsuka shall notify Ionis and if Xxxxx agrees with Otsuka’s determination that a “for cause” audit is needed, Ionis will schedule and conduct such audit and Otsuka will [***], in each case, to the extent permitted pursuant to the applicable agreement with the such CMO.
By Otsuka. Otsuka shall indemnify, defend and hold ISTA, its directors, employees, agents and representatives harmless from and against all claims, causes of action, settlement costs (including reasonable attorney fees and expenses), losses or liabilities of any kind which are asserted by a Third Party and that (i) arise out of the negligent act or omission or willful misconduct by Otsuka or its Affiliate in the performance of its obligations under this Agreement, or (ii) arise out of the handling, possession, use, marketing, distribution or sale of any Product or Product In Final Form, which Product or Product In Final Form is not Defective at the time of delivery to Otsuka, following delivery of the Product to Otsuka as provided herein; except, in all cases, to the extent such claims, causes of action, settlement costs, losses or liabilities are subject to indemnification by ISTA under Section 4.2 above, or Section 13.2 of the License Agreement. Notwithstanding the foregoing, in the event that Otsuka exercises its Manufacturing License pursuant to Sections 2.14 herein, then with respect to Product or Product In Final Form manufactured by Otsuka or any Otsuka contract manufacturer, Otsuka shall be required to provide the indemnification requirements of Section 4.2 (ii) and (iii) as if it were ISTA for purposes of that Section 4.2 (ii) and (iii).
By Otsuka. If Perception elects to inspect or audit any facilities of its CMOs or other Third Party manufacturers or Third Party laboratories with respect to Manufacture or testing of API or Clinical Samples for the Otsuka Territory, Perception shall notify Otsuka of such inspection or audit and to the extent permitted under the agreement with the applicable CMO or other Third Party manufacturer or laboratory and subject to any conditions set forth in such agreement with respect to any inspection or audit (e.g., entering into a confidentiality agreement with the applicable CMO or other Third Party), Otsuka shall have the right, but not the obligation, to have [***] (together with an interpreter) participate in such inspection or audit or to accompany Perception and observe and review such inspection or audit. Perception shall use Commercially Reasonable Efforts to include in each future agreement between Perception and such CMOs and other Third Party manufacturers and Third Party laboratories (and, to the extent not already included, to amend any such existing agreement to include) such inspection and audit rights for Otsuka as provided in this Section 7.5.1 and as provided in the Supply Agreement and Quality Agreement. In addition, Perception shall provide Otsuka with copies of all reports of Perception’s audits or inspections of its CMOs and other Third Party manufacturers and Third Party laboratories relating to Manufacture or testing of API and Clinical Samples for the Otsuka Territory. Perception retains the right to conduct “for cause” audits of the facilities of its CMOs, other Third Party manufacturers and Third Party laboratories; provided that, if Otsuka identifies the need to perform a “for cause” audit of such facilities to address quality or compliance issues related to API or Clinical Samples Manufactured for the Otsuka Territory (including to address any notice from a Governmental Authority of noncompliance with Applicable Laws), as well as in connection with the preparation for submission of Regulatory Documentation in Otsuka Territory and in response to Regulatory Authority requirements in the Otsuka Territory, Otsuka shall notify Perception and Perception shall schedule and conduct such audit to the extent permitted pursuant the applicable agreement with the such CMO, Third Party manufacturer or Third Party laboratory.
By Otsuka. Otsuka shall indemnify, defend and hold ISTA, its directors, employees, agents and representatives harmless from and against all claims, causes of action, settlement costs (including reasonable attorney fees and expenses), losses or liabilities of any kind that are asserted by a Third Party and that: (i) arise from a breach of representation or warranty in Section 12.2, or (ii) arise out of the negligence or willful misconduct of Otsuka or its Affiliates in the performance of its obligations under this Agreement; except, in all cases, to the extent that such claim arises out of the negligence or willful misconduct of ISTA, its Affiliates or ISTA Contract Manufacturer, or the breach by of any warranties given by ISTA in Section 12.1 above.
