Non-Conformance Clause Samples
POPULAR SAMPLE Copied 44 times
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreements. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Vaccinex or during the shelf life set forth in Section 8.2 (in either case, a “Non-Conformance Event”), then unless otherwise agreed to by the Parties, Merck shall replace such Merck Compound as is found to have a Non-Conformance (with respect to Merck Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Vaccinex with respect to any Merck Compound that is found to have a Non-Conformance at the time of Delivery shall be (i) replacement of such Merck Compound as set forth in this Section 8.7.2(b), (ii) indemnification under Section 14.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 or 6.7 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, for clarity, that Vaccinex shall not be deemed to be waiving any rights under Section 8.15.
(c) In the event that Merck Compound is lost or damaged after Delivery, Merck may provide additional Merck Compound to Vaccinex, if available for the Study. Such replaced Merck Compound shall be provided to Vaccinex, so long as the amount replaced does not in the aggregate exceed [***] of the total quantity of Merck Compound to be provided by Merck pursuant to Appendix B (such amount set forth on Appendix B, the “Replacement Note: Reference to “Merck” in this document refers to the Group of Companies affiliated with Merck KGaA, Darmstadt, Germany. Threshold”). Vaccinex shall pay Merck the Manufacturing Costs per vial of any replaced Merck Compound beyond the Replacement Threshold which Merck agrees to supply; provided that the Manufacturing Cost per vial of Merck Compound charged by Merck pursu...
Non-Conformance. Vendor assumes all liability for delivering goods that do not meet the specification(s) and standard(s) specified on the face of the PO. Any non- conforming goods and/or services which are delivered to PISD are accepted under a “reservation of PISD’s rights” to contest, dispute, request offsets, reject, or return the non-conforming goods and/or services, in whole or in part. Any tender of goods or performance of services by Vendor which are non-conforming as to the quality, quantity, or the delivery schedule shall constitute a breach of this PO and PISD shall have the absolute right to reject the goods and/or services, in whole or in part. In the event that PISD does not accept any goods and/or services which have been submitted to PISD, PISD is entitled to any and all remedies that are provided by law. In addition to the U.C.C. allowed contract by contract right of setoff, PISD is entitled to a “party by party” right of set off. PISD is not required to mitigate its damages in order to obtain the relief for any breach of contract remedies available to it. In addition, PISD has the right to do any or all of the following, in PISD’s sole discretion:
a. to hold the non-conforming goods and/or services for a reasonable period at Vendor’s risk and expense pending a determination to accept or reject any or all thereof;
b. to return the non-conforming goods and/or services to Vendor at PISD’s election and at Vendor’s risk and expense for replacement or correction, in which case Vendor shall use best efforts to replace any non-conforming goods and/or services at Vendor’s risk and expense;
c. to accept the non-conforming goods and/or services subject to an equitable price reduction;
d. to replace or correct the non-conforming goods and/or services and charge to Vendor the cost occasioned to PISD thereby;
e. to recover by offset or otherwise any and all expenses, costs, price reductions, and damages paid, incurred, or suffered by PISD as a result of the holding, return, replacement, correction, reductions, or rejections of non-conforming goods and/or services; and/or
f. to terminate the PO and/or any contract entered into between PISD and Vendor.
Non-Conformance i. In the event that a Party becomes aware that the Idera Compound Delivered hereunder may have a nonfulfillment or unplanned departure of a specified requirement from documented GxP procedures, instructions, requirements, filed specifications, or processes (“Non-Conformance”), despite testing and quality assurance activities, then such Party will notify the other Party’s relevant Quality contact set forth in Attachment C (or as updated) within [**] Business Days of becoming aware of the Non-Conformance. Idera and AbbVie will investigate any Non-Conformance as set forth in Section 6(b)(ii) (Investigations) below and any discrepancy between the Parties regarding the determination of Non-Conformance shall escalated per each of the Party’s respective quality system requirements. AbbVie shall determine whether a shipment of the Idera Compound (or portion thereof) has a Non-Conformance at the time of Delivery within [**] days after the date of Delivery of such Idera Compound (or portion thereof). Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound. In the event that any proposed or actual shipment of the Idera Compound (or portion thereof) will be agreed or otherwise determined to have a Non-Conformance at the time of Delivery to AbbVie, then unless otherwise agreed to by the Parties in writing, Idera will use commercially reasonable efforts to replace such Idera Compound as is found to have a Non-Conformance as soon as reasonably practical and at no cost to AbbVie. Any Idera Compound not rejected by written notice to Idera within [**] days of AbbVie’s receipt shall be deemed accepted, except for Idera Compound that is found later to have had latent defect(s) that were not reasonably discoverable within [**] days after receipt of Delivery of such Idera Compound.
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3.
(b) In the event that any proposed or actual shipment of the MSD Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Intensity, then unless otherwise agreed to by the Parties, MSD shall replace such MSD Compound as is found to have a Non-Conformance (with respect to MSD Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, [***] with respect to any MSD Compound that is found to have a Non-Conformance at the time of Delivery shall be [***] provided that, for clarity, [***] In the event MSD Compound is lost or damaged by Intensity after Delivery, MSD shall [***] provided that [***] and provided further [***].
(c) Intensity shall be responsible for, and MSD shall have no obligation or liability with respect to, any Intensity Compound supplied hereunder that is found to have a Non-Conformance. Intensity shall replace any Intensity Compound as is found to have a Non-Conformance (with respect to Intensity Compound that has not yet been administered in the course of performing the Study). Unless otherwise agreed to by the Parties in writing, [***]with respect to any Intensity Compound that is found to have a Non-Conformance at the time of Delivery shall be[***]; provided that, for clarity[***] .
Non-Conformance. If Services do not conform to the undertakings under this clause 4, Cyanre will, at its expense, use all reasonable commercial endeavours to correct any such non-conformance promptly, or provide the Customer with an alternative means of accomplishing the desired performance. Such correction or substitution constitutes the Customer's sole and exclusive remedy for any breach of an undertaking set out in clause 4. Notwithstanding the foregoing, Cyanre:
4.13.1 does not warrant that the Customer's use of the Services will be uninterrupted or error-free; nor that the Services and/or the information obtained by the Customer through the Services will meet the Customer's requirements; and
4.13.2 is not responsible for any delays, delivery failures, or any other loss or damage resulting from the transfer of data over communications networks and facilities, including the internet, and the Customer acknowledges that the Services may be subject to limitations, delays and other problems inherent in the use of such communication facilities.
Non-Conformance. 2.9.2.1 Contractor shall record results of Functional Performance Tests and Integrated System Tests. Contractor or Commissioning Authority if engaged for the project shall report all Deficiencies and non-conformance issues to Commissioning ▇▇▇▇.▇▇ accordance with the procedures outlined in the Commissioning Plan.
2.9.1.2 At the sole discretion of Owner, Owner may permit Contractor to make corrections of minor Deficiencies observed during a Functional Performance Test or during an Integrated System Test. However, the Contractor must document the Deficiency and resolution on the appropriate report form.
2.9.1.3 Contractor shall make every effort to expedite testing and minimize unnecessary delays, while not compromising the integrity of a Functional Performance Test or an Integrated Systems Test.
2.9.1.4 Contractor, A/E and Owner will attempt to resolve Deficiencies in the following manner.
2.9.1.4.1 When there is no dispute about a Deficiency and Contractor accepts responsibility for correction.
2.9.1.4.1.1 Commissioning Authority if engaged for the project or Contractor documents the Deficiency and the corrective actions, and then proceeds to another test or sequence. A Deficiency report is submitted to Owner. Contractor corrects the Deficiency, completes the statement of correction form certifying that the equipment or system is ready for retesting, and sends the certification to Owner.
Non-Conformance. 8.9.2.1 If either Party becomes aware that any Compound may have a Non- Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.9.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party. Notification related to MSD Compound shall be in accordance with the Clinical Supply Quality Agreement. MSD shall investigate any Non-Conformance of the MSD Compound in accordance with the Clinical Supply Quality Agreement.
8.9.2.2 If all or any portion of any proposed or actual shipment of the MSD Compound is agreed to be Non-Conforming at the time of Delivery to Collaborator then MSD shall replace any such Non-Conforming MSD Compound that has not been administered. [***]. MSD shall have no obligation to provide additional MSD Compound more than once. MSD shall have no obligation to immediately replace in-kind and quantity MSD Compound that is expiring or has expired while in the Collaborator’s possession. Collaborator must discuss this situation with MSD. Except as set forth in this Section 8.9.2.2. MSD shall have no obligation to replace any MSD ▇▇▇▇▇▇▇▇ supplied hereunder.
8.9.2.3 Collaborator shall be responsible for, and MSD shall have no obligation or liability with respect to, any Collaborator Compound that is found to have a Non-Conformance. Collaborator shall replace any such Collaborator Compound that has not been administered. The sole and exclusive remedies of MSD with respect to any Collaborator Compound that is found to have a Non-Conformance at the time of Delivery shall be: [***].
Non-Conformance. If Parent reasonably believes that any Licensed Product, any component thereof, or any materials used to advertise, market or promote the Licensed Products do not conform to the Applicable Standards or any other requirement of this Agreement (either during the new product development process or after the Licensed Product has been Sold), Parent may give notice to Licensee that it desires to meet and discuss its findings with Licensee and have Licensee create (or cause to be created) a corrective action plan. To the extent Licensee’s corrective action plan is not implemented or is not effective to resolve the identified issue or concern, Licensee will submit to Parent a revised corrective action plan and Parent will have the right to submit questions or concerns in accordance with Section 3.2(d), and the process outlined in Section 3.2(d) shall apply mutatis mutandis to revised corrective action plans covering non-conforming Licensed Products. If, notwithstanding the implementation and adoption of corrective action plans in accordance with Section 3.2(d), the applicable Licensed Product continues not to conform to the Applicable Standards or any other requirement of this Agreement, or if Licensee fails to implement such corrective action plans, then, without prejudice to Parent’s right to terminate the Agreement in accordance with Article 7, Licensee shall (and shall ensure Permitted Sublicensees) promptly cease manufacturing, Selling, advertising, marketing, promoting, and servicing such non-conforming Licensed Products or advertising, marketing and promotional materials in connection with the ▇▇ ▇▇▇▇▇. Licensee acknowledges, on behalf of itself and Permitted Sublicensees and Vendors, that any use of the ▇▇ ▇▇▇▇▇ during a suspension period in contravention of this Section 3.6 shall be deemed unauthorized and infringing.
Non-Conformance. | The warranties in Clause 3.1 (Minimum Standard Warranty) shall not apply to the extent of any non- conformance which is caused by the use of the Subscription Service contrary to Cutover’s instructions, other than in accordance with the terms of this Agreement, or modification or alteration of the Subscription Service by any person other than Cutover or the Personnel (including a Customer Provider) that has not been authorised in writing by Cutover. Subject to Clause 13 (Disclaimers & Restrictions), if the Subscription Service does not conform to the warranties at Clause 3.1, Cutover will, at its expense, attempt to correct any such non-conformance promptly, or provide Customer with an alternative means of accomplishing the desired performance.
Non-Conformance. 15 8.1 Non-Conformance.......................................................................................................................................................................................................................................................................................... 15 8.2 No BioVectra Liability for Non-Conforming Product............................................................................................................................................................................................................................... 16 8.3 BioVectra Liability for Non-Conforming Product; Replacement............................................................................................................................................................................................................ 16 8.4 Cooperation in Investigations; Disposition of Non-Conforming Product........................................................................................................................................................................................... 16 8.5 Third Party / Arbitration............................................................................................................................................................................................................................................................................... 16