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 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 (Resolution of Discrepancies).
(b) In the event that any proposed or actual shipment of the Merck Compound (or portion thereof) shall be agreed to have a Non-Conformance at the time of Delivery to Syndax or shall otherwise be determined under the Clinical Quality Agreement to have a Non-Conformance at the time of Delivery to Syndax, 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 Syndax 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 13.2 (to the extent applicable) and (iii) termination of this Agreement pursuant to Section 6.3 (to the extent applicable, but subject to the applicable cure periods set forth therein); provided, for clarity, that Syndax shall not be deemed to be waiving any rights under Section 8.15 (Recalls). In the event that Merck Compound is lost or damaged after Delivery and as a result additional Merck Compound is necessary for the Study, Merck shall provide additional Merck Compound, if available for the Study, to Syndax, provided that *** shall *** for the *** of such additional Merck Compound, and provided further that Merck shall have no obligation to provide replacement Merck Compound for any Merck Compound supplied hereunder other than such Merck Compound as has been agreed or determined to have a Non-Conformance at the time of Delivery to Syndax.
(c) Syndax shall be responsible for, and Merck shall have no obligations or liability with respect to, any Syndax Compound supplied hereunder that is found to have a Non-Conformance. Syndax shall replace any S...
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. 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. 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, in each case, other than with respect to immaterial non-conformance with the Usage Guidelines; provided, that Licensee is using good faith efforts to correct such non-conformance, 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 XX Xxxxx. Licensee acknowledges, on behalf of itself and Permitted Sublicensees and Vendors, that any use of the XX Xxxxx during a suspension period in contravention of this Section 3.6 shall be deemed unauthorized and infringing.
Non-Conformance. 11.2.1 Additional Material or Product that do not meet established Specifications shall be handled as Non-conformities and documented as such, in accordance with Strakan’s or its Contract Manufacturer’s standard operating procedures. Actions taken to investigate Non-conformity and to justify the release of the Lot of Product or Batch shall be fully documented.
11.2.2 Aptalis and Strakan shall approve the Non-conformity document as stated below prior to initial release. Any resulting corrective actions shall be followed through timely closure. * Confidential treatment requested. Non-conformance Approval Requirements API Aptalis and Strakan excipient Strakan Product Aptalis and Strakan primary packaging Additional Material manufacturer Aptalis and Strakan printed packaging Additional Material Aptalis and Strakan
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
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 Xxxx.xx 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. Helix may reject any Product on the ground that it is non-conforming by giving written notice thereof to BioVectra (an “NC Notice”) within sixty (60) days after the delivery date for such Product. Such written notice shall specify the manner in which such Product fails to conform to the warranties set forth in Sections 11.1 and 11.2 and shall be accompanied by any test results or reports evidencing such non-conformity. For a period of twenty-one (21) days following BioVectra’s receipt of an NC Notice, the Parties shall diligently and in good faith seek to reach agreement on whether a nonconformity exists and, if so, whether such nonconformity was caused by BioVectra’s breach of the warranties set forth in Sections 11.1 and 11.2.
Non-Conformance. Helix may reject any Product on the ground that it is non-conforming by giving written notice thereof to CPL (an “NC Notice”) within sixty (60) days after the Delivery Date for such Product. Such written notice shall specify the manner in which such Product fails to conform to the warranties set forth in Sections 11.1 and 11.2 and shall be accompanied by any test results or reports evidencing such non-conformity. For a period of twenty-one (21) days following CPL’s receipt of an NC Notice, the Parties shall diligently and in good faith seek to reach agreement on whether a nonconformity exists and, if so, whether such nonconformity was caused by CPL’s breach of the warranties set forth in Sections 11.1 and 11.2.
Non-Conformance. If a party determines that Tested Systems of the other party fail to conform to the Acceptance Criteria in one or more material respects (each, a “Defect”), then the party refusing acceptance shall provide the other party a report identifying each such Defect. Thereafter, the parties shall cooperate to allocate responsibility for remedying each such Defect and each party shall, as applicable in accordance with such allocation, (i) use good faith efforts to promptly remedy the Defect(s), and (ii) notify the other party once it reasonably believes such Defect(s) has (have) been remedied.
