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By Otsuka Sample Clauses

By OtsukaPrior 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 applicable CMO.
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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 conductfor 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 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. 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.

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  • By Licensee Licensee shall defend, indemnify, and hold harmless Licensor, its Affiliates, sublicensees, the licensors under the Existing Licenses, and their respective shareholders, members, partners, officers, trustees, faculty, students, contractors, agents, and employees (individually, a “Licensor Indemnified Party” and, collectively, the “Licensor Indemnified Parties”) from and against any and all Third Party liability, loss, damage, action, claim, fee, cost, or expense (including attorneys’ fees) (individually, a “Third Party Liability” and, collectively, the “Third Party Liabilities”) suffered or incurred by the Licensor Indemnified Parties from claims of such Third Parties that result from or arise out of: […***…]; provided, however, that Licensee shall not be liable for claims based on any breach by Licensor of the representations, warranties, or obligations of this Agreement or the gross negligence or intentional misconduct of any of the Licensor Indemnified Parties. Without limiting the foregoing, Licensee must defend, indemnify, and hold harmless the Licensor Indemnified Parties from and against any Third Party Liabilities resulting from: (a) any […***…] or other claim of any kind related to the […***…] by a Third Party of a […***…] by Licensee, its Affiliates, any Sublicensees, their respective assignees, or vendors; (b) any claim by a Third Party that the […***…]; and (c) […***…] conducted by or on behalf of Licensee, its Affiliates, any Sublicensees, their respective assignees, or vendors relating to the Licensed Technology or Licensed Products, including any claim by or on behalf of a […***…].

  • By Licensor Licensor will indemnify, defend and hold harmless Licensee and its Affiliates, and their respective directors, officers and employees (“Licensee Indemnitees”) from and against any and all Third Party Claims and associated Liabilities to the extent arising directly or indirectly from any material breach by Licensor of the terms of this Agreement..

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

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  • Licensee “Licensee” means the individual or company that has entered into an Agreement with the Embassy. “Offer” means a response to a solicitation that, if accepted, would bind the offeror to perform the resultant Agreement.

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  • Research Program The term “

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

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