Common use of Non-Conforming Product Clause in Contracts

Non-Conforming Product. Supplier must notify X X Xxxx of any significant Non conformance which affects the product. Concessions can only be granted with Main customer approval and must be signed by X X Xxxx and Supplier. Copy of concession to be held by X X Xxxx and supplier. Approval of procedures Any procedures requiring approval will be notified to supplier in PO. Two copies of Procedures must be forwarded to X X Xxxx for approval. After approval signed copy will be returned to Supplier. Approval of processes Any processes requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. NOTE: Supplier must use customer-approved special process sources when notified by X X Xxxx. Details of source/s will be forwarded to Supplier as part of purchasing process. X X Xxxx will visit supplier to approve processes, as appropriate. NOTE: It is a requirement that the supplier notifies X X Xxxx of any process changes which may affect the product/service ordered by X X Xxxx. This is of utmost importance if change affects a Key Characteristic. Approval of Changes Any changes in product and/or process, changes of suppliers, changes of manufacturing facility location, including any approval registrations/certificates i.e. ISO 9001 or AS9100. Where required, XX Xxxx must be informed prior to any change being completed. Approval of equipment Any equipment requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. Approval can be achieved by forwarding machine capability studies as appropriate. Supplier will be notified by X X Xxxx of approval. Certificate of Conformance (C of C) Requirement for C of C will be stated in PO C of C must be signed by Supplier’s Quality representative and state that products/materials have been inspected and or tested and meet X X Xxxx and/or customer specification. Counterfeit product Requirement for assuring traceability of parts and components to their original or authorised manufacturers. XX Xxxx must be informed of any Reporting and quarantining of suspected or detected counterfeit parts which could impact on product conformance Material Test Certificates Requirement for Mill Certificate will be stated in PO. Mill Certificate must be forwarded to X X Xxxx for all metals. Qualifications of personnel Any specific Qualification relating to personnel will be stated in PO. Qualification of personnel will only apply when specified by X X Xxxx Customer. Record Control All records created by and /or retained by suppliers must be controlled. All records created by suppliers must be controlled and held for a minimum period of 15 years unless otherwise stated. Disposition of records to be notified and authorised by XX Xxxx prior to records being destroyed. Records must be available to our customers and Regulatory Authorities on request. Quality Management System requirements Any specific requirements relating to Quality Management Systems (QMS) will be stated in PO. It is preferred for the supplier to hold AS9100, or if not ISO9001 certification for its QMS Right of access X X Xxxx, its customer or Regulatory Authority reserves the right to visit their suppliers and 2nd tier suppliers involved in the order to carry out an audit or investigate a complaint. Arrangements for visit will be agreed with supplier by X X Xxxx. Flow down of purchasing documentation and key characteristics. It is the supplier’s responsibility to flow down X X Xxxx’x requirements to sub tier suppliers. Supplier must make sure that sub tier supplier is made aware of all Key Characteristics relating to the product/process.

Non-Conforming Product. Supplier must notify X X Xxxx of any significant Non conformance which affects the product. Concessions can only be granted with Main customer approval and must be signed by X X Xxxx and Supplier. Copy of concession to be held by X X Xxxx and supplierxxxxxxxx. Approval of procedures Any procedures requiring approval will be notified to supplier in PO. Two copies of Procedures must be forwarded to X X Xxxx for approval. After approval signed copy will be returned to Supplier. Approval of processes Any processes requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. NOTE: Supplier must use customer-approved special process sources when notified by X X Xxxx. Details of source/s will be forwarded to Supplier as part of purchasing process. X X Xxxx will visit supplier to approve processes, as appropriate. NOTE: It is a requirement that the supplier notifies X X Xxxx of any process changes which may affect the product/service ordered by X X Xxxx. This is of utmost importance if change affects a Key Characteristic. Approval of Changes Any changes in product and/or process, changes of suppliers, changes of manufacturing facility location, including any approval registrations/certificates i.e. ISO 9001 or AS9100. Where required, XX Xxxx must be informed prior to any change being completed. Approval of equipment Any equipment requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. Approval can be achieved by forwarding machine capability studies as appropriate. Supplier will be notified by X X Xxxx of approval. Certificate of Conformance (C of C) Requirement for C of C will be stated in PO C of C must be signed by Supplier’s Quality representative and state that products/materials have been inspected and or tested and meet X X Xxxx and/or customer specification. Counterfeit product Requirement for assuring traceability of parts and components to their original or authorised manufacturers. XX Xxxx must be informed of any Reporting and quarantining of suspected or detected counterfeit parts which could impact on product conformance Material Test Certificates Requirement for Mill Certificate will be stated in PO. Mill Certificate must be forwarded to X X Xxxx for all metals. Qualifications of personnel Any specific Qualification relating to personnel will be stated in PO. Qualification of personnel will only apply when specified by X X Xxxx Customer. Record Control All records created by and /or retained by suppliers must be controlled. All records created by suppliers must be controlled and held for a minimum period of 15 years unless otherwise stated. Disposition of records to be notified and authorised by XX Xxxx prior to records being destroyed. Records must be available to our customers and Regulatory Authorities on request. Quality Management System requirements Any specific requirements relating to Quality Management Systems (QMS) will be stated in PO. It is preferred for the supplier to hold AS9100, or if not ISO9001 certification for its QMS Right of access X X Xxxx, its customer or Regulatory Authority reserves the right to visit their suppliers and 2nd tier suppliers involved in the order to carry out an audit or investigate a complaint. XX Xxxx suppliers shall maintain a list of approved suppliers. Arrangements for visit will be agreed with supplier by X X Xxxx. Flow down of purchasing documentation and key characteristics. It is the supplier’s responsibility to flow down X X Xxxx’x requirements to sub tier suppliers. Supplier must make sure shall ensure that sub tier supplier is made aware of all Key Characteristics relating to the product/process. Supplier shall maintain list of approved sub-tier suppliers. Awareness of Product Safety & Ethical Behaviour Ensure that persons are aware of their contribution to product/service conformity and product safety, and the importance of working in an ethical way. Suppliers shall (where possible) ensure product safety and ethical behaviours are upheld throughout their processes and operations, this requirement shall be flown down to sub tiers also.

Non-Conforming Product. Supplier must notify X X Xxxx XXX NI of any significant Non Non-conformance which affects the product. Supplier must notify XXX NI within 24 hours of any suspected nonconforming product which has been shipped. Concessions can only be granted with Main customer approval and must be signed by X X Xxxx XXX NI and Supplier. Copy of concession to be held by X X Xxxx SAM NI and supplier. Approval of procedures Any procedures requiring approval will be notified to supplier in PO. Two copies of Procedures must be forwarded to X X Xxxx XXX NI for approval. After approval signed copy will be returned to Supplier. Approval of processes Any processes requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. NOTE: Supplier must use customer-approved special process sources when notified by X X XxxxSAM NI. Details of source/s will be forwarded to Supplier as part of purchasing process. X X Xxxx XXX NI will visit supplier to approve processes, as appropriate. NOTE: It is a requirement that the supplier notifies X X Xxxx XXX NI of any process changes which may affect the product/service ordered by X X XxxxSAM NI. This is of utmost importance if change affects a Key Characteristic. Approval of Changes Any changes in product and/or process, changes of suppliers, changes of manufacturing facility location, including any approval registrations/certificates i.e. ISO 9001 or AS9100. Where required, XX Xxxx must be informed prior to any change being completed. Approval of equipment Any equipment requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. Approval can be achieved by forwarding machine capability studies as appropriate. Supplier will be notified by X X Xxxx XXX NI of approval. Certificate of Conformance (C of C) Requirement for C of C will be stated in PO C of C must be signed by Supplier’s Quality representative and state that products/materials have been inspected and or tested and meet X X Xxxx XXX NI and/or customer specification. Counterfeit product Requirement for assuring traceability of parts and components to their original or authorised manufacturers. XX Xxxx must be informed of any Reporting and quarantining of suspected or detected counterfeit parts which could impact on product conformance Material Test Certificates Requirement for Mill Certificate will be stated in PO. Mill Certificate must be forwarded to X X Xxxx XXX NI for all metals. Qualifications of personnel Any specific Qualification relating to personnel will be stated in PO. Qualification of personnel will only apply when specified by X X Xxxx XXX NI Customer. Record Control All records created by and /or retained by suppliers must be controlled. All records created by suppliers must be controlled and held for a minimum period of 15 years unless otherwise stated. Disposition of records to be notified and authorised by XX Xxxx prior to records being destroyed. Records must be available to our customers and Regulatory Authorities on request. Quality Management System requirements Any specific requirements relating to Quality Management Systems (QMS) will be stated in PO. It is preferred for the supplier to hold AS9100, or if not ISO9001 certification for its QMS Right of access X X XxxxXXX NI, its customer or Regulatory Authority reserves the right to visit their suppliers and 2nd tier suppliers involved in the order to carry out an audit or investigate a complaint. XX Xxxx suppliers shall maintain a list of approved suppliers. Arrangements for visit will be agreed with supplier by X X XxxxSAM NI. Flow down of purchasing documentation and key characteristics. It is the supplier’s responsibility to flow down X X Xxxx’x XXX NI’s requirements to sub tier suppliers. Supplier must make sure shall ensure that sub tier supplier is made aware of all Key Characteristics relating to the product/process. Supplier shall maintain list of approved sub-tier suppliers. Awareness of Product Safety & Ethical Behaviour Ensure that persons are aware of their contribution to product/service conformity and product safety, and the importance of working in an ethical way. Suppliers shall (where possible) ensure product safety and ethical behaviours are upheld throughout their processes and operations, this requirement shall be flown down to sub tiers also.

Non-Conforming Product. Supplier must Xxxxx will be entitled, but not obliged, at its cost and expense and using the test methods set forth in the sNDAs or other applicable cGMP test methods used by Lilly at the time such Product was manufactured, to test any and all Product delivered to it hereunder to determine whether such Product complies with the Specifications. Xxxxx will use validated methods to test Product. Xxxxx will notify X X Xxxx Lilly in writing promptly, and in any event not later than forty-five (45) days after delivery thereof if it rejects any Product delivered to it because such Product failed to meet the Specifications. Any notice of rejection by Xxxxx shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any significant Non conformance pertinent analysis performed by Xxxxx on the allegedly nonconforming product, together with the methods and procedures used. Lilly shall notify Xxxxx as promptly as reasonably possible, but in any event within forty-five (45) business days after receipt of such notice of rejection, whether it accepts Galen's assertions of non-conformity. If Xxxxx rejects any such Product it will, at Lilly's request, provide Lilly with the opportunity to conduct its own tests on such rejected Product. Product not rejected within the forty-five (45) day period will be deemed accepted and, without in any way limiting Lilly's indemnity obligations set forth in Section 11.1, will constitute a waiver of any claims Xxxxx may have against Lilly with respect to the purchase price for such shipment; subject, however, to Galen's right to reject any Product for Latent Defects discovered by Xxxxx and promptly reported to Lilly. Lilly will use commercially reasonable efforts to replace the properly rejected Product with Product which affects meets the productSpecifications within a commercially reasonable time and will deliver such replacement Product, at Lilly's sole cost and expense, to Xxxxx. Concessions can only be granted with Main customer approval In addition, Lilly will, at Lilly's sole cost and must be signed by X X Xxxx and Supplier. Copy of concession expense, arrange for all such rejected Product to be held by X X Xxxx and supplierpicked up promptly and, where applicable, destroyed in accordance with all Applicable Laws. Approval of procedures Any procedures requiring approval Product properly rejected in accordance with this Section 5.3(a) will not be applied to the applicable Purchase Maximums, Purchase Minimums, the purchase obligation set forth in Section 2.2, or the minimum purchase or maximum supply obligations set forth in Section 4.4(a); but replacement Product will be notified to supplier in PO. Two copies of Procedures must be forwarded to X X Xxxx for approval. After approval signed copy will be returned to Supplier. Approval of processes Any processes requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. NOTE: Supplier must use customer-approved special process sources when notified by X X Xxxx. Details of source/s will be forwarded to Supplier as part of purchasing process. X X Xxxx will visit supplier to approve processes, as appropriate. NOTE: It is a requirement that the supplier notifies X X Xxxx of any process changes which may affect the product/service ordered by X X Xxxx. This is of utmost importance if change affects a Key Characteristic. Approval of Changes Any changes in product and/or process, changes of suppliers, changes of manufacturing facility location, including any approval registrations/certificates i.e. ISO 9001 or AS9100. Where required, XX Xxxx must be informed prior to any change being completed. Approval of equipment Any equipment requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. Approval can be achieved by forwarding machine capability studies as appropriate. Supplier will be notified by X X Xxxx of approval. Certificate of Conformance (C of C) Requirement for C of C will be stated in PO C of C must be signed by Supplier’s Quality representative and state that products/materials have been inspected and or tested and meet X X Xxxx and/or customer specification. Counterfeit product Requirement for assuring traceability of parts and components to their original or authorised manufacturers. XX Xxxx must be informed of any Reporting and quarantining of suspected or detected counterfeit parts which could impact on product conformance Material Test Certificates Requirement for Mill Certificate will be stated in PO. Mill Certificate must be forwarded to X X Xxxx for all metals. Qualifications of personnel Any specific Qualification relating to personnel will be stated in PO. Qualification of personnel will only apply when specified by X X Xxxx Customer. Record Control All records created by and /or retained by suppliers must be controlled. All records created by suppliers must be controlled and held for a minimum period of 15 years unless otherwise stated. Disposition of records to be notified and authorised by XX Xxxx prior to records being destroyed. Records must be available to our customers and Regulatory Authorities on request. Quality Management System requirements Any specific requirements relating to Quality Management Systems (QMS) will be stated in PO. It is preferred for the supplier to hold AS9100, or if not ISO9001 certification for its QMS Right of access X X Xxxx, its customer or Regulatory Authority reserves the right to visit their suppliers and 2nd tier suppliers involved in the order to carry out an audit or investigate a complaint. Arrangements for visit will be agreed with supplier by X X Xxxx. Flow down of purchasing documentation and key characteristics. It is the supplier’s responsibility to flow down X X Xxxx’x requirements to sub tier suppliers. Supplier must make sure that sub tier supplier is made aware of all Key Characteristics relating applied to the product/processapplicable Purchase Maximums, Purchase Minimums, the purchase obligations set forth in Section 2.2, and the minimum purchase or maximum supply obligations set forth in Section 4.4(a).

Non-Conforming Product. Supplier must notify X X Xxxx of any significant Non conformance which affects the product. Concessions can only be granted with Main customer approval and must be signed by X X Xxxx and Supplier. Copy of concession to be held by X X Xxxx and supplierxxxxxxxx. Approval of procedures Any procedures requiring approval will be notified to supplier in PO. Two copies of Procedures must be forwarded to X X Xxxx for approval. After approval signed copy will be returned to Supplier. Approval of processes Any processes requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. NOTE: Supplier must use customer-approved special process sources when notified by X X Xxxx. Details of source/s will be forwarded to Supplier as part of purchasing process. X X Xxxx will visit supplier to approve processes, as appropriate. NOTE: It is a requirement that the supplier notifies X X Xxxx of any process changes which may affect the product/service ordered by X X Xxxx. This is of utmost importance if change affects a Key Characteristic. Approval of Changes Any changes in product and/or process, changes of suppliers, changes of manufacturing facility location, including any approval registrations/certificates i.e. ISO 9001 or AS9100. Where required, XX Xxxx must be informed prior to any change being completed. Approval of equipment Any equipment requiring approval will be notified to supplier in PO. Arrangements for approval will be detailed. Approval can be achieved by forwarding machine capability studies as appropriate. Supplier will be notified by X X Xxxx of approval. Certificate of Conformance (C of C) Requirement for C of C will be stated in PO C of C must be signed by Supplier’s Quality representative and state that products/materials have been inspected and or tested and meet X X Xxxx and/or customer specification. Counterfeit product Requirement for assuring traceability of parts and components to their original or authorised manufacturers. XX Xxxx must be informed of any Reporting and quarantining of suspected or detected counterfeit parts which could impact on product conformance Material Test Certificates Requirement for Mill Certificate will be stated in PO. Mill Certificate must be forwarded to X X Xxxx for all metals. Qualifications of personnel Any specific Qualification relating to personnel will be stated in PO. Qualification of personnel will only apply when specified by X X Xxxx Customer. Record Control All records created by and /or retained by suppliers must be controlled. All records created by suppliers must be controlled and held for a minimum period of 15 years unless otherwise stated. Disposition of records to be notified and authorised by XX Xxxx prior to records being destroyed. Records must be available to our customers and Regulatory Authorities on request. Quality Management System requirements Any specific requirements relating to Quality Management Systems (QMS) will be stated in PO. It is preferred for the supplier to hold AS9100, or if not ISO9001 certification for its QMS Right of access X X Xxxx, its customer or Regulatory Authority reserves the right to visit their suppliers and 2nd tier suppliers involved in the order to carry out an audit or investigate a complaint. Arrangements for visit will be agreed with supplier by X X Xxxx. Flow down of purchasing documentation and key characteristics. It is the supplier’s responsibility to flow down X X Xxxx’x requirements to sub tier suppliers. Supplier must make sure that sub tier supplier is made aware of all Key Characteristics relating to the product/process.