Common use of Quality Standards Clause in Contracts

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this Order. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order or any previous purchase order. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctions, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) Ontic’s Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order.

Quality Standards. (a) The Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this OrderPO. When requested, so requested Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, processes and other related documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of any Goods delivered during the period of such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, customers and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this OrderPO. (dc) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, investigation or auditing. (ed) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order PO or any previous purchase orderPOs. (e) Seller shall notify Buyer within twenty-four (24) hours of the discovery of any defect in the Goods furnished under this PO or any previous POs. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, specifications and standards required by Buyer, its customers Customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authorityPO. (g) Seller shall report immediately will ensure all Products and Services provided to Buyer any known malfunctions, defects, and/or un-airworthy conditions with respect that their employees are aware of their contribution to defect and/or un-airworthy conditionProduct/ Service Conformity and their actions contribute to Product Safety. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) Ontic’s Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order.

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this Order. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order or any previous purchase order. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctions, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) Ontic’s Buyer Supplier Quality Assurance Control Requirements (SQAR), which can be found under “SQCR) US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, (PUF-101-3) at xxxxx://xxx.xxxxx.xxx/img/US-Creedmoor-Ontic- Firstmark-Aircraft-Belts-Supplier-Quality-Control-Requirements.pdf are hereby incorporated into, and as a condition of, this Order. Buyer is a sister company of Ontic Engineering and Manufacturing, Inc. and it is on Ontic’s website where quality and supplier resources are found.

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this OrderPO. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, processes and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, trained and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-first class quality and workmanship. (c) Buyer, its customers, customers and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this OrderPO. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, investigation or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order PO or any previous purchase orderPOs. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, specifications and standards required by Buyer, its customers Customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authorityPO. (g) Seller shall report immediately to Buyer any known malfunctions, defects, defects and/or un-airworthy conditions with respect to any Goods and provide a disposition to mitigate such malfunction, defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this OrderPO. Seller shall obtain approval from Buyer in regard regards to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s 's prior written approval of any such changes. (j) Ontic’s Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order.

Quality Standards. (a) The Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this OrderPO. When requested, so requested Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, processes and other related documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of any Goods delivered during the period of such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, customers and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller and Seller's and its suppliers’ lower-tier subcontractor’s manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this OrderPO. (dc) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, investigation or auditing. (ed) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order PO or any previous purchase orderPOs. (e) Seller shall notify Buyer within twenty-four (24) hours of the discovery of any defect in the Goods furnished under this PO or any previous POs. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, specifications and standards required by Buyer, its customers Customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authorityPO. (g) Seller shall report immediately ensure to Buyer any known malfunctionsuse customer designated or approved external providers, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy conditionincluding process sources (i.e. special processes) if applicable. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) Ontic’s Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order.

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this Order. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practicesprac- tices, processes, and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified quali- fied employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including in- cluding government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processespro- cesses, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditionscondi- tions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication fab- rication processes for Goods covered by this Order or any previous previ- ous purchase order. (f) Seller shall ensure that all of its subcontractors are provided pro- vided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or regulatory authorities, with respect to the Goods furnished under this OrderOr- der. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctionsmalfunc- tions, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform con- form to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written writ- ten approval of any such changes. (j) Ontic’s Buyer Supplier Quality Assurance Control Requirements (SQAR), which can be found under “SQCR) US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, (PUF-101-3) at xxxxx://xxx.xxxxx.xxx/img/US-Creedmoor- Ontic-Firstmark-Aircraft-Belts-Supplier-Quality-Control- Requirements.pdf are hereby incorporated into, and as a condition condi- tion of, this Order. Buyer is a sister company of Ontic Engineer- ing and Manufacturing, Inc. and it is on Ontic’s website where quality and supplier resources are found.

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this Order. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practicesprac- tices, processes, and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified quali- fied employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including in- cluding government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processespro- cesses, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditionscondi- tions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication fab- rication processes for Goods covered by this Order or any previous previ- ous purchase order. (f) Seller shall ensure that all of its subcontractors are provided pro- vided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or regulatory authorities, with respect to the Goods furnished under this OrderOr- der. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctionsmalfunc- tions, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform con- form to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written writ- ten approval of any such changes. (j) Ontic’s Buyer’ Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order.website

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this Order. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order or any previous purchase order. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctions, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) Ontic’s Buyer Supplier Quality Assurance Control Requirements (SQAR), which can be found under “) US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, (PUF-101-3) at xxxxx://xxx.xxxxx.xxx/img/PUF-101-3-Supplier- Quality-Assurance-Requirements.pdf are hereby incorporated into, and as a condition of, this Order. Buyer is a sister company of Ontic Engineering and Manufacturing, Inc. and it is on Ontic’s website where quality and supplier resources are found.

Quality Standards. (a) Seller shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable to Buyer for the Goods delivered under this Order. When requested, Seller shall submit to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, and other documents. Seller will have the continuing obligation to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including government agencies, will have the right to audit and/or inspect Seller's and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of Buyer for any change to the product configuration, including engineering design and fabrication processes for Goods covered by this Order or any previous purchase order. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or regulatory authorities, with respect to the Goods furnished under this Order. Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctions, defects, and/or un-airworthy conditions with respect to defect and/or un-airworthy condition. (h) Seller shall notify Buyer of any product that does not conform to the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming Goods. (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) OnticBuyer’s Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order. Buyer is a sister company of Ontic Engineering and Manufacturing, Inc. and it is on Ontic’s website where quality and supplier resources are found.

Quality Standards. (a) Seller Buyer shall implement and maintain a quality program compliant with AS9100 or ISO9001 or acceptable have access to Buyer Seller's Quality ----------------- Assurance SOP's for the Goods delivered under this OrderProduct, with proprietary information subject to reasonable protection, and to all quality systems employed by Seller in connection with the manufacture and packaging of the Product. When requestedIn addition, Seller shall submit provide the documentation necessary to Buyer, for Buyer’s approval, the quality program documentation, including Seller’s procedures, instructions, practices, processes, and other documents. Seller will have the continuing obligation allow Buyer to immediately notify Buyer of a change or deviation from Seller’s approved quality program and to notify Buyer of Goods delivered during such change or deviation. (b) Seller agrees to use only experienced, trained, and qualified employees in the performance of its obligations under this Agreement and all Services performed must be of first-class quality and workmanship. (c) Buyer, its customers, and its higher-level contractors, including government agencies, will have the right to audit and/or inspect reference Seller's relevant Master File(s) in any submissions with the FDA and its suppliers’ manufacturing facilities, processes, inspection systems, quality assurance systems, data, and equipment as may be related to any international regulatory filings or approvals in connection with the Goods furnished under this Order. (d) Upon request, Seller shall, where applicable, submit test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation, or auditing. (e) Seller must have prior approval of the Buyer's Device. Buyer for shall provide Seller with a copy of any change to proposed filing or submission with the product configuration, including engineering design and fabrication processes for Goods covered by this Order FDA or any previous purchase order. (f) Seller shall ensure that all of its subcontractors are provided with any and all applicable requirements, specifications, and standards required by Buyer, its customers or international regulatory authorities, agency with respect to the Goods furnished under this Order. Buyer's Device which includes Seller's proprietary information or other information from Seller's Master Files or Quality Assurance SOP's, and Buyer shall not be responsible for the performance of any subcontractors engaged by Seller including any subcontractors Seller is required to engage due to source control content set forth in any requirements, specifications, or standards provided to Seller by Buyer, its customers, or any regulatory authority. (g) Seller shall report immediately to Buyer any known malfunctions, defects, and/or un-airworthy conditions receive Seller's approval with respect to defect such filing or submission prior to filing or submitting the material to the FDA or international regulatory agency. All of Seller's proprietary information with respect to the Product shall be subject to reasonable protection and Buyer shall comply with Seller's rules and procedures with respect thereto. Seller shall, at no cost or expense to Seller, cooperate with Buyer's reasonable requests for information and assistance with respect to all FDA and international regulatory filings, audits and approvals associated with the Product being sold to Buyer hereunder, and Seller shall, at no cost or expense to Seller, reasonably cooperate with Buyer to address any cGMP deficiencies noted during any such FDA audit associated with the Product being sold to Buyer hereunder. Buyer agrees to handle, store and distribute the Product in a manner consistent with the conditions stated on the Product labeling and the conditions stated in Buyer's submission(s) to the FDA and/or un-airworthy condition. (h) foreign regulatory agencies. Nothing set forth herein shall require Seller to provide Buyer with any information pertaining to Seller's batch records of the Product or with any information pertaining to the proprietary processes utilized in manufacturing the Product, all such information being deemed trade secrets of Seller. Buyer and Seller shall notify Buyer execute and keep on file, a contract manufacturing agreement in the form of any product that does not conform to Schedule 3 ---------- attached hereto, or such other form as Seller may determine is required by the specifications described or referenced by Buyer on this Order. Seller shall obtain approval from Buyer in regard to disposition of any such nonconforming GoodsU. S. Center for Biologics Evaluation and Research ("CBER"). (i) Seller shall notify Buyer of any change in Goods, design, materials, process, suppliers, manufacturing facility location and, unless otherwise indicated, shall obtain Buyer’s prior written approval of any such changes. (j) Ontic’s Supplier Quality Assurance Requirements (SQAR), which can be found under “US Chatsworth Supplier Quality Assurance Requirements” on the following website page under “Supplier Resources” xxxxx://xxx.xxxxx.xxx/resources, are hereby incorporated into, and as a condition of, this Order.