Cooperation in Investigations; Disposition of Non-Conforming Drug Substance Sample Clauses

Cooperation in Investigations; Disposition of Non-Conforming Drug Substance. Each Party shall act in good faith and shall cooperate with the other Party, with any qualified independent Third-Party laboratory in connection with an investigation, and with the arbitrator, as to the existence of or source of nonconformity with respect to a Clinical Batch supplied under this Agreement. In testing the Batch, any independent Third-Party laboratory shall use analytical testing methods as agreed upon by the Parties. At PROTEON’S election, LONZA shall either (i) dispose of any Non-Conforming Drug Substance in accordance with all relevant laws, rules and regulations with respect to such disposal, at LONZA’s cost if LONZA was liable for the nonconformity in accordance with Section 10.3 and at PROTEON’s cost if LONZA was not liable for the nonconformity in accordance with Section 10.2, or (ii) deliver the Non-Conforming Drug Substance to PROTEON in accordance with Section 5.1.
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Cooperation in Investigations; Disposition of Non-Conforming Drug Substance. If Tercica desires to make a claim against CBSB with respect to and reject a Batch of Non-Conforming Drug Substance pursuant to Section 13.1, Tercica agrees that it shall not dispose of or allow such Drug Substance to be disposed of without written authorization and instructions from CBSB either to dispose of or return to CBSB such Non-Conforming Drug Substance. Upon written request by Tercica, CBSB agrees promptly to give Tercica such authorization and instructions within a reasonable period of time. Each Party shall act in good faith and shall cooperate with the other Party and with any mutually acceptable qualified independent Third Party in connection with an investigation as to the existence of or source of any Non-Conforming Drug Substance supplied under this Agreement. At the request of Tercica, CBSB will provide all Non-Conforming Drug Substance to Tercica, at no cost to Tercica (except for shipping and delivery expenses payable under Article 7 hereof), in accordance with the delivery terms set forth in Section 7.4 hereof, and Tercica may make whatever further use of such Non-Conforming Drug Substance as it shall determine; provided, however, that Tercica agrees that (i) such Non-Conforming Drug Substance shall not be used in humans, (ii) the warranties provided in Sections 17.1 and 17.2 of this Agreement shall not apply to such Non-Conforming Drug Substance, and (iii) the disclaimer of warranties set forth in Section 17.3 of this Agreement shall apply to such Non-Conforming Drug Substance. CBSB shall in no way be responsible for any claims, losses, expenses or damages, whatsoever, arising out of or in any way related to Tercica’s use of such Non-Conforming Drug Substance. CBSB shall dispose of any Non-Conforming Drug Substance returned by Tercica in accordance with all relevant Regulatory Requirements for such disposal, at CBSB’s cost if CBSB was liable for such Non-Conforming Drug Substance in accordance with Section 13.3 and at Tercica’s cost if CBSB was not liable for such Non-Conforming Drug Substance in accordance with Section 13.2.
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Cooperation in Investigations; Disposition of Non-Conforming Drug Substance. Each Party shall act in good faith and shall cooperate with the other Party, with any qualified independent Third-Party laboratory in connection with an investigation, and with the arbitrator, as to the existence of or source of nonconformity with respect to a Clinical Batch supplied under this Agreement. In testing the Clinical Batch, any independent Third-Party laboratory shall use analytical testing methods as agreed upon by the Parties. LONZA shall dispose of any Non-Conforming Drug Substance in accordance with all relevant laws, rules and regulations with respect to such disposal, at LONZA’s cost if LONZA was liable for the nonconformity in accordance with Section 10.3 and at Client’s cost if LONZA was not liable for the nonconformity in accordance with Section 10.2. [*] = Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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Related to Cooperation in Investigations; Disposition of Non-Conforming Drug Substance

  • Inspection and Rejection of Nonconforming Goods (a) Buyer shall inspect the goods within five days of receipt (“Inspection Period”). Xxxxx will be deemed to have accepted the goods unless it notifies Seller in writing of any Nonconforming Goods during the Inspection Period and furnishes documentation reasonably required by Seller. “

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Response/Compliance with Audit or Inspection Findings A. Grantee must act to ensure its and its Subcontractors’ compliance with all corrections necessary to address any finding of noncompliance with any law, regulation, audit requirement, or generally accepted accounting principle, or any other deficiency identified in any audit, review, or inspection of the Contract and the services and Deliverables provided. Any such correction will be at Grantee’s or its Subcontractor's sole expense. Whether Xxxxxxx's action corrects the noncompliance shall be solely the decision of the System Agency.

  • CERTIFICATION OF NO ASBESTOS CONTAINING MATERIALS OR WORK 8.1 The Contractor shall be responsible for ensuring that no asbestos containing materials or work is included within the scope of the Work. The Contractor shall take whatever measures it deems necessary to insure that all employees, suppliers, fabricators, material men, subcontractors, or their assigns, comply with this requirement.

  • Non-Conforming Product If Reliant notifies Cardinal Health during the Review Period that the Manufacturing Sample does not conform to the warranty set forth in Section 13.1 and Cardinal Health agrees with Client’s determination, Client shall not be responsible to pay for such batch (the “Defective Product”), and Cardinal Health shall, at Reliant’s option, either (A) replace any Batch of non-conforming Product, or (B) credit any payments made by Reliant for such Batch. If Cardinal Health does not agree with Reliant’s determination that such Product fails to meet the warranty set forth in Section 13.1, then after reasonable efforts to resolve the disagreement, the Parties shall cause a mutually acceptable independent third party to review records, test data and to perform comparative tests and/or analyses on the Manufacturing Sample. The results of the independent review shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party. THE OBLIGATION OF CARDINAL HEALTH TO (A) REPLACE DEFECTIVE PRODUCT IN ACCORDANCE WITH THE SPECIFICATIONS OR CREDIT PAYMENTS MADE BY RELIANT FOR DEFECTIVE PRODUCT AND (B) REIMBURSE RELIANT FOR API LOST IN THE DEFECTIVE BATCH, SUBJECT TO THE LIMITATIONS IN ARTICLE 15.1, SHALL BE RELIANT’S SOLE AND EXCLUSIVE REMEDY (WITHOUT PREJUDICE TO ANY INDEMNIFICATION OBLIGATIONS UNDER SECTION 14.1 OR THE OBLIGATIONS OF SECTION 10.6 (RECALL)) UNDER THIS ARTICLE FOR DEFECTIVE PRODUCT AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

  • Penalties for non-conformity of production 9.1. The approval granted in respect of a vehicle type pursuant to this Regulation may be withdrawn if the requirements set forth above are not met.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Removal of Improvements Except as otherwise expressly agreed to by Lessor and Lessee, Lessee shall have the right to remove all Tank Farm Assets and other improvements, fixtures, equipment, materials, supplies and personal property installed by Lessee from the Premises upon the termination or expiration of this Lease, but in no event later than the date that is 120 days following the expiration or termination of this Lease (the “Removal Date”) and Lessor shall provide Lessee with access to the Premises at reasonable times until expiration of the Removal Date for the purpose of removing such items. Lessee shall provide Lessor with written notice of its election to remove the Tank Farm Assets and other improvements, fixtures, equipment, materials, supplies and personal property from the Premises at least 60 days prior to the expiration of the Lease. If Lessee elects to remove the Tank Farm Assets and Improvements from the Premises after such removal Lessee shall restore any damage to the Premises and clean the Premises so as to eliminate therefrom any accumulation (other than any de minimis and non-hazardous accumulation) of foreign substances, materials, or debris, in addition to any Environmental Cleanup that may be required under Article 10. Lessee shall pay Lessor pro rata Rent (based on the amount of Rent applicable during the last month prior to the termination or expiration) through the date of Lessee’s complete removal of all such items. During the period of such removal and clean-up, all terms and conditions of this Lease, including, the indemnity and insurance provisions shall continue in full force and effect. If Lessee elects not to remove all of the Tank Farm Assets and Improvements from the Premises on or before the Removal Date, and provided that such facilities are in good working condition at the expiration of the Term (ordinary wear and tear excepted) then, such Tank Farm Assets and Improvements shall be deemed permanently abandoned to Lessor’s sole ownership, and Lessor may remove and dispose of such facilities in any manner which Lessor may deem appropriate, without any liability whatsoever to Lessee. If Lessee elects not to remove all of the Tank Farm Assets and Improvements from the Premises on or before the Removal Date and such facilities are not in good working condition at the expiration of the term (ordinary wear and tear excepted), or Lessee fails to so remove any or all of the Tank Farm Assets and Improvements from the Premises before the Removal Date, then, in addition to all rights and remedies available at law or in equity, without any prior notice, Lessor may (but shall be under no obligation), at Lessor’s option, deem such Tank Farm Assets and Improvements to be permanently abandoned to Lessor’s sole ownership, and Lessor may remove and dispose of such facilities in any manner which Lessor may deem appropriate, without any liability whatsoever to Lessee, and Lessee shall reimburse Lessor for all costs of such removal and disposal upon demand from Lessor. If requested by Lessor, Lessee shall execute any and all documents necessary to evidence that title to the Tank Farm Assets and Improvements that Lessee does not remove by the Removal Date is in Lessor and to extinguish and remove any cloud or potential cloud on the title to the Premises and/or such facilities created by Lessee.

  • Limitations on Reverse Engineering, Decompilation, and Disassembly You may not reverse engineer, decompile, or disassemble the Software, except and only to the extent that such activity is expressly permitted by applicable law notwithstanding this limitation.

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