{"component": "clause", "props": {"groups": [{"snippet": "11.1 Under the terms of this Agreement, Supplier shall have and operate a process to ensure that all Products, sub-assemblies and the components contained therein supplied to the Buyer are completely Traceable back to manufacturer by batch or lot or date code.\n11.2 Further Supplier hereby agrees, unless directed otherwise by the Buyer, to procure components through franchised distributors or direct component Suppliers. Supplier agrees to indemnify and hold the Buyer harmless from and against all costs and expenses for the removal, repair or replacement and reinstallation of counterfeit components incorporated into a Product sold by Supplier to the Buyer where the counterfeit component was procured by Supplier from a person or entity other than a franchised distributor or direct component Supplier or other person or entity pre-approved by the Buyer in writing.", "size": 31, "snippet_links": [{"key": "terms-of-this-agreement", "type": "clause", "offset": [15, 38]}, {"key": "supplier-shall", "type": "clause", "offset": [40, 54]}, {"key": "to-ensure", "type": "clause", "offset": [82, 91]}, {"key": "all-products", "type": "clause", "offset": [97, 109]}, {"key": "to-the-buyer", "type": "clause", "offset": [172, 184]}, {"key": "by-the-buyer", "type": "clause", "offset": [324, 336]}, {"key": "indemnify-and-hold", "type": "clause", "offset": [442, 460]}, {"key": "costs-and-expenses", "type": "clause", "offset": [501, 519]}, {"key": "repair-or-replacement", "type": "definition", "offset": [537, 558]}, {"key": "counterfeit-components", "type": "definition", "offset": [581, 603]}, {"key": "by-supplier", "type": "clause", "offset": [637, 648]}, {"key": "person-or-entity", "type": "clause", "offset": [726, 742]}, {"key": "franchised-distributor", "type": "definition", "offset": [756, 778]}, {"key": "other-person", "type": "definition", "offset": [811, 823]}, {"key": "approved-by", "type": "clause", "offset": [838, 849]}, {"key": "in-writing", "type": "definition", "offset": [860, 870]}], "samples": [{"hash": "aThy9AOn8ef", "uri": "/contracts/aThy9AOn8ef#traceability", "label": "Purchase Agreement", "score": 35.1546669006, "published": true}, {"hash": "iC34Aazk7LQ", "uri": "/contracts/iC34Aazk7LQ#traceability", "label": "Purchase Agreement", "score": 35.153377533, "published": true}, {"hash": "htRl3T2qOTy", "uri": "/contracts/htRl3T2qOTy#traceability", "label": "Purchase Agreement", "score": 25.8172492981, "published": true}], "hash": "46109189cba4511ad6951ce2333697b1", "id": 1}, {"snippet": "The supplier is responsible for thorough traceability within the established scope and for appropriate labeling of components and containers until delivery to voestalpine or a designated third party. Deliveries to voestalpine shall be clearly labeled in accordance with the drawing specifications with item numbers, batch and manufacturer\u2019s labels, if appropriate. The supplier shall ensure traceability with a label affixed to the component. If there is a complaint, it must be possible to draw a clear conclusion about the disputed delivery in order to limit the quantities of defective parts and source materials. Upon request (e.g. if there is a claim), the supplier must be able to provide voestalpine with traceability regarding its production data, input materials and purchased parts, if any.", "size": 13, "snippet_links": [{"key": "responsible-for", "type": "clause", "offset": [16, 31]}, {"key": "scope-and", "type": "clause", "offset": [77, 86]}, {"key": "designated-third-party", "type": "definition", "offset": [176, 198]}, {"key": "in-accordance-with", "type": "clause", "offset": [251, 269]}, {"key": "the-supplier-shall", "type": "clause", "offset": [365, 383]}, {"key": "in-order-to", "type": "clause", "offset": [543, 554]}, {"key": "the-quantities", "type": "clause", "offset": [561, 575]}, {"key": "defective-parts", "type": "clause", "offset": [579, 594]}, {"key": "source-materials", "type": "definition", "offset": [599, 615]}, {"key": "upon-request", "type": "clause", "offset": [617, 629]}, {"key": "the-supplier-must", "type": "clause", "offset": [658, 675]}, {"key": "to-provide", "type": "definition", "offset": [684, 694]}, {"key": "production-data", "type": "clause", "offset": [739, 754]}, {"key": "input-materials", "type": "definition", "offset": [756, 771]}, {"key": "purchased-parts", "type": "definition", "offset": [776, 791]}], "samples": [{"hash": "7JQCJUwRQ7o", "uri": "/contracts/7JQCJUwRQ7o#traceability", "label": "Quality Assurance Agreement", "score": 32.8287887573, "published": true}, {"hash": "6OWRYhMVvPQ", "uri": "/contracts/6OWRYhMVvPQ#traceability", "label": "Quality Assurance Agreement", "score": 25.9075965881, "published": true}, {"hash": "c2Ls5C4pXHp", "uri": "/contracts/c2Ls5C4pXHp#traceability", "label": "Quality Assurance Agreement", "score": 25.8377819061, "published": true}], "hash": "d81202f2ddcb5ffcce51253a4d885b8b", "id": 2}, {"snippet": "Supplier must trace the source and origin of all goods and materials to be used in connection with this Agreement and make such information available to GM for prior written approval before any such direct or indirect supplier may be used in connection with this Agreement (the \u201cSupply Chain Map\u201d). Supplier will not change the source or origin of any goods or materials identified in the Supply Chain Map without first obtaining GM\u2019s advance written consent. For clarity, written consent to change the source or origin of any goods or materials identified in the Supply Chain Map must be obtained directly from GM. Supplier will put policies and process in place to obtain sourcing and origin information from sub-tier suppliers and include all such information in the Supply Chain Map upon receipt. Supplier will proactively, and on an ongoing basis, monitor the source and origin of all goods and material used in connection with this Agreement. Supplier must obtain GM\u2019s prior written consent to the procurement of any goods or materials used in connection with this Agreement that originate or are otherwise extracted, processed, recycled, manufactured or assembled, in whole or in part:\n(i) by an FEOC; or\n(ii) in a territory identified in Country Group D, Supplement No. 1 to 15 C.F.R. Part 740: (see \u2587\u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587.\u2587\u2587\u2587.\u2587\u2587\u2587/index.php/documents/regulation-docs/2255-supplement-no-1-to-part-740-country-groups-1/file). Egypt, Israel, United Arab Emirates, Uzbekistan and Vietnam are excluded from the Country Group D supplement. GM may, in its discretion, authorize purchases from such other Group D territories for which a risk mitigation plan is approved by GM. Supplier will comply with all applicable GM policies, as amended, relating to supply chain resiliency and compliance. Supplier will incorporate, and require its subcontractors at all tiers to incorporate, these terms and any applicable GM policy in its contract for goods or materials used in connection with this Agreement.", "size": 7, "snippet_links": [{"key": "supplier-must", "type": "clause", "offset": [0, 13]}, {"key": "origin-of", "type": "definition", "offset": [35, 44]}, {"key": "all-goods", "type": "clause", "offset": [45, 54]}, {"key": "materials-to-be", "type": "clause", "offset": [59, 74]}, {"key": "in-connection-with", "type": "clause", "offset": [80, 98]}, {"key": "this-agreement", "type": "clause", "offset": [99, 113]}, {"key": "available-to", "type": "definition", "offset": [140, 152]}, {"key": "prior-written-approval", "type": "definition", "offset": [160, 182]}, {"key": "direct-or-indirect", "type": "clause", "offset": [199, 217]}, {"key": "supply-chain", "type": "definition", "offset": [279, 291]}, {"key": "supplier-will", "type": "clause", "offset": [299, 312]}, {"key": "for-clarity", "type": "clause", "offset": [460, 471]}, {"key": "consent-to-change", "type": "clause", "offset": [481, 498]}, {"key": "in-place", "type": "clause", "offset": [655, 663]}, {"key": "information-from", "type": "clause", "offset": [694, 710]}, {"key": "upon-receipt", "type": "definition", "offset": [787, 799]}, {"key": "prior-written-consent", "type": "clause", "offset": [975, 996]}, {"key": "materials-used", "type": "clause", "offset": [1032, 1046]}, {"key": "group-d", "type": "clause", "offset": [1254, 1261]}, {"key": "supplement-no", "type": "clause", "offset": [1263, 1276]}, {"key": "see-\u2587", "type": "clause", "offset": [1304, 1309]}, {"key": "united-arab-emirates", "type": "clause", "offset": [1440, 1460]}, {"key": "the-country", "type": "definition", "offset": [1503, 1514]}, {"key": "in-its-discretion", "type": "clause", "offset": [1543, 1560]}, {"key": "other-group", "type": "definition", "offset": [1592, 1603]}, {"key": "risk-mitigation-plan", "type": "definition", "offset": [1630, 1650]}, {"key": "approved-by", "type": "clause", "offset": [1654, 1665]}, {"key": "comply-with", "type": "definition", "offset": [1684, 1695]}, {"key": "as-amended", "type": "definition", "offset": [1724, 1734]}, {"key": "relating-to", "type": "definition", "offset": [1736, 1747]}, {"key": "and-compliance", "type": "clause", "offset": [1772, 1786]}, {"key": "subcontractors-at-all-tiers", "type": "definition", "offset": [1831, 1858]}, {"key": "terms-and", "type": "clause", "offset": [1881, 1890]}, {"key": "contract-for-goods", "type": "definition", "offset": [1923, 1941]}], "samples": [{"hash": "afAW56wqIvD", "uri": "/contracts/afAW56wqIvD#traceability", "label": "Lithium Offtake Agreement (Lithium Americas Corp.)", "score": 36.2361412048, "published": true}, {"hash": "8ouRkPOZT3Q", "uri": "/contracts/8ouRkPOZT3Q#traceability", "label": "Lithium Offtake Agreement (Lithium Americas Corp.)", "score": 36.2361412048, "published": true}, {"hash": "37ShDn54DqF", "uri": "/contracts/37ShDn54DqF#traceability", "label": "Investment Agreement (Lithium Americas Corp.)", "score": 35.2361412048, "published": true}], "hash": "13784ed568e06fab144cac96302a7130", "id": 9}, {"snippet": "Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a sig- nificant injury to the user shall estab- lish and maintain procedures for iden- tifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate correc- tive action. Such identification shall be documented in the DHR.", "size": 10, "snippet_links": [{"key": "failure-to-perform", "type": "clause", "offset": [122, 140]}, {"key": "in-accordance-with", "type": "clause", "offset": [160, 178]}, {"key": "instructions-for-use", "type": "clause", "offset": [179, 199]}, {"key": "the-user-shall", "type": "clause", "offset": [291, 305]}, {"key": "control-number", "type": "definition", "offset": [367, 381]}, {"key": "where-appropriate", "type": "definition", "offset": [431, 448]}, {"key": "the-procedures", "type": "definition", "offset": [461, 475]}], "samples": [{"hash": "6yt6lLozhq9", "uri": "/contracts/6yt6lLozhq9#traceability", "label": "Fda Regulations", "score": 29.0434017181, "published": true}, {"hash": "8zIIdD0nKJo", "uri": "/contracts/8zIIdD0nKJo#traceability", "label": "Quality Management System Agreement", "score": 26.0242404938, "published": true}, {"hash": "ipst7jTYIN2", "uri": "/contracts/ipst7jTYIN2#traceability", "label": "Quality Management System Agreement", "score": 25.6711196899, "published": true}], "hash": "1c39d7345ddb4cb5506f3bca7dbc8479", "id": 6}, {"snippet": "If the Agreement obligates Timken to provide traceability on Products or Service Items, Timken\u2019s obligation with respect to Products and Service Items returned to Timken (a) is limited by the accuracy and completeness of the information provided by Buyer with respect to the returned Products and Service Items, and (b) will terminate if the return was not authorized in advance by Timken.", "size": 8, "snippet_links": [{"key": "the-agreement", "type": "clause", "offset": [3, 16]}, {"key": "to-provide", "type": "definition", "offset": [34, 44]}, {"key": "service-items", "type": "definition", "offset": [73, 86]}, {"key": "with-respect-to", "type": "clause", "offset": [108, 123]}, {"key": "accuracy-and-completeness-of", "type": "clause", "offset": [192, 220]}, {"key": "by-buyer", "type": "clause", "offset": [246, 254]}, {"key": "returned-products", "type": "definition", "offset": [275, 292]}, {"key": "in-advance", "type": "clause", "offset": [368, 378]}], "samples": [{"hash": "4ZnpraZfzin", "uri": "/contracts/4ZnpraZfzin#traceability", "label": "Terms and Conditions of Sale", "score": 22.6112251282, "published": true}, {"hash": "cQzQsTJRR5b", "uri": "/contracts/cQzQsTJRR5b#traceability", "label": "Terms and Conditions of Sale", "score": 22.4757022858, "published": true}, {"hash": "hLzjjyJaYFu", "uri": "/contracts/hLzjjyJaYFu#traceability", "label": "Terms and Conditions of Sale", "score": 21.9445590973, "published": true}], "hash": "2574983de1724fd71470553c1e2fe549", "id": 8}, {"snippet": "Buyer will create and maintain accurate records of all activities and events related to the Products to the extent necessary to ensure product traceability. The records will be constructed in such a manner that all significant activities or events will be traceable for a period of not less than 2 years past the expiration date or 2 years after the device has been taken out of service, whichever occurs first. Such records must be clear, readily available, and include the following: (i) each order received and accepted; (ii) the serial or lot number and expiration date of the Product(s) and the address where Product(s) are delivered; (iii) the method of identifying the invoice issued to a customer; and (iv) each customer credit issued and the reason therefor.", "size": 10, "snippet_links": [{"key": "buyer-will", "type": "clause", "offset": [0, 10]}, {"key": "accurate-records", "type": "clause", "offset": [31, 47]}, {"key": "activities-and-events", "type": "clause", "offset": [55, 76]}, {"key": "related-to", "type": "clause", "offset": [77, 87]}, {"key": "the-products", "type": "clause", "offset": [88, 100]}, {"key": "to-the-extent", "type": "clause", "offset": [101, 114]}, {"key": "to-ensure", "type": "clause", "offset": [125, 134]}, {"key": "product-traceability", "type": "clause", "offset": [135, 155]}, {"key": "the-records", "type": "clause", "offset": [157, 168]}, {"key": "period-of", "type": "definition", "offset": [272, 281]}, {"key": "expiration-date", "type": "clause", "offset": [313, 328]}, {"key": "the-device", "type": "clause", "offset": [346, 356]}, {"key": "out-of-service", "type": "definition", "offset": [372, 386]}, {"key": "readily-available", "type": "definition", "offset": [440, 457]}, {"key": "each-order", "type": "clause", "offset": [490, 500]}, {"key": "received-and-accepted", "type": "definition", "offset": [501, 522]}, {"key": "lot-number", "type": "clause", "offset": [543, 553]}, {"key": "date-of", "type": "clause", "offset": [569, 576]}, {"key": "method-of", "type": "definition", "offset": [650, 659]}, {"key": "issued-to", "type": "definition", "offset": [684, 693]}, {"key": "customer-credit", "type": "clause", "offset": [720, 735]}], "samples": [{"hash": "alZk06eNPe6", "uri": "/contracts/alZk06eNPe6#traceability", "label": "Terms and Conditions of Sale", "score": 25.0423851013, "published": true}, {"hash": "kA2Qp9fvzv0", "uri": "/contracts/kA2Qp9fvzv0#traceability", "label": "Terms and Conditions of Sale", "score": 23.4355506897, "published": true}, {"hash": "eSHmMncWuto", "uri": "/contracts/eSHmMncWuto#traceability", "label": "Terms and Conditions of Sale", "score": 23.3901443481, "published": true}], "hash": "e09d422a9f575dc417a384aab450c326", "id": 7}, {"snippet": "If the Contractor is not the original manufacturer of, or authorized supplier for, an electronic part, the Contractor shall\u2014\n(1) Have risk-based processes (taking into consideration the consequences of failure of an electronic part) that enable tracking of electronic parts from the original manufacturer to product acceptance by the Government, whether the electronic part is supplied as a discrete electronic part or is contained in an assembly;\n(2) If the Contractor cannot establish this traceability from the original manufacturer for a specific electronic part, be responsible for inspection, testing, and authentication, in accordance with existing applicable industry standards; and\n(i) Maintain documentation of traceability (paragraph (c)(1) of this clause) or the inspection, testing, and authentication required when traceability cannot be established (paragraph (c)(2) of this clause) in accordance with FAR subpart 4.7; and\n(ii) Make such documentation available to the Government upon request.", "size": 12, "snippet_links": [{"key": "if-the-contractor", "type": "clause", "offset": [0, 17]}, {"key": "original-manufacturer", "type": "definition", "offset": [29, 50]}, {"key": "authorized-supplier", "type": "clause", "offset": [58, 77]}, {"key": "an-electronic", "type": "clause", "offset": [83, 96]}, {"key": "the-contractor-shall", "type": "clause", "offset": [103, 123]}, {"key": "taking-into-consideration", "type": "clause", "offset": [156, 181]}, {"key": "consequences-of-failure", "type": "clause", "offset": [186, 209]}, {"key": "electronic-parts", "type": "definition", "offset": [257, 273]}, {"key": "by-the-government", "type": "clause", "offset": [327, 344]}, {"key": "the-electronic", "type": "clause", "offset": [354, 368]}, {"key": "contained-in", "type": "definition", "offset": [422, 434]}, {"key": "an-assembly", "type": "definition", "offset": [435, 446]}, {"key": "for-inspection", "type": "clause", "offset": [583, 597]}, {"key": "and-authentication", "type": "clause", "offset": [608, 626]}, {"key": "in-accordance-with", "type": "clause", "offset": [628, 646]}, {"key": "industry-standards", "type": "clause", "offset": [667, 685]}, {"key": "this-clause", "type": "clause", "offset": [755, 766]}, {"key": "the-inspection", "type": "clause", "offset": [771, 785]}, {"key": "authentication-required", "type": "clause", "offset": [800, 823]}, {"key": "available-to", "type": "definition", "offset": [967, 979]}, {"key": "upon-request", "type": "clause", "offset": [995, 1007]}], "samples": [{"hash": "3JPAuKmlbdl", "uri": "/contracts/3JPAuKmlbdl#traceability", "label": "Terms and Conditions", "score": 33.0872383118, "published": true}, {"hash": "jiySyl7c0GR", "uri": "/contracts/jiySyl7c0GR#traceability", "label": "Blanket Purchase Agreement", "score": 32.3190155029, "published": true}, {"hash": "7cc0LdETWRs", "uri": "/contracts/7cc0LdETWRs#traceability", "label": "Blanket Purchase Agreement", "score": 26.6563987732, "published": true}], "hash": "5cf24aacc06066a8f8c5a2a2325e66b5", "id": 3}, {"snippet": "Customer will create and maintain accurate records of all activities and events related to the Products to the extent necessary to ensure product traceability. The records will be constructed in such a manner that all significant activities or events will be traceable for a period of not less than 10 years past the date or manufacture. Such records must be clear, readily available, and include the following: (i) each order received and accepted; (ii) the serial or lot number and expiration date of the Product(s) and the address where Product(s) are delivered; (iii) the method of identifying the invoice issued to an end customer; and (iv) each end customer credit issued and the reason therefor. Customer Complaints. Customer will cooperate fully with Merz in dealing with end customer complaints concerning the Products and will take such action to resolve such complaints as deemed necessary or appropriate by Customer or as may be otherwise reasonably requested by Merz. Customer agrees to report to Merz any complaint regarding a Product of which Customer becomes aware within 24 hours of becoming aware. Customer agrees to assist Merz to facilitate the resolution of complaints. For purposes of this Agreement, a complaint can be the occurrence of any of the following: (i) receipt of any Product(s) quality claims, medical claims, or complaints or other written claims or complaints; or (ii) receipt of any written communication from any applicable regulatory agency pertaining to a Product. Anti-Kickback Statute. It is the intent of Customer and Merz to comply with the Anti-Kickback Statute (42 U.S.C. \u00a71320a-7b(b)) and the Discount Safe Harbor and Warranties Safe Harbor regulations set forth in 42 C.F.R. 1001.952(h) and (g), respectively. Customer\u2019s price may constitute a \u2018discount or other reduction in price\u2019 under the Anti-Kickback Statute. Merz will provide Customer with invoices that fully and accurately disclose the discounted price of all Products purchased under this Agreement to allow Customer to comply with this Section and the Discount Safe Harbor regulations, including sufficient information to enable it to accurately report its actual cost for all purchases of Products. Customer acknowledges that, if applicable, it will fully and accurately report all discounts or other price reductions, including warranty items, in the costs claimed or charges made under any Federal or State healthcare program and provide information upon request to third-party reimbursement programs. Customer will be solely responsible for determining whether any savings or discount or warranty item it receives must be reported or passed on to payors. Foreign Corrupt Practices Act. Customer will comply with all applicable anti-corruption, anti-bribery, and anti-kickback laws, rules, and regulations, including, without limitation, the United States Foreign Corrupt Practices Act (15 U.S.C. \u00a778dd-1, et seq.) and other laws, rules, and regulations applicable to where Customer conducts business. Limitation of Liabilities and Remedies. UNDER NO CIRCUMSTANCES WILL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER PARTY FOR, AND EACH PARTY HEREBY EXPRESSLY WAIVES, ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES OF ANY DESCRIPTION, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, WHETHER ARISING OUT OF WARRANTY OR CONTRACT, NEGLIGENCE OR OTHER TORT, OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, FORESEEABLE BUSINESS LOSSES, LOSS OF PROFITS, AND RELIANCE DAMAGES. CUSTOMER AGREES THAT UNDER NO CIRCUMSTANCES WILL \u2587\u2587\u2587\u2587\u2019\u2587 LIABILITY RELATING TO ITS SALE OF PRODUCTS TO BUYER FOR ANY CAUSE EXCEED THE PURCHASE PRICE PAID BY CUSTOMER FOR THE PARTICULAR PRODUCTS INVOLVED. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, THE REMEDIES SET FORTH IN THIS AGREEMENT WILL APPLY EVEN IF SUCH REMEDIES FAIL THEIR ESSENTIAL PURPOSE.", "size": 6, "snippet_links": [{"key": "customer-will", "type": "clause", "offset": [0, 13]}, {"key": "accurate-records", "type": "clause", "offset": [34, 50]}, {"key": "activities-and-events", "type": "clause", "offset": [58, 79]}, {"key": "related-to", "type": "clause", "offset": [80, 90]}, {"key": "the-products", "type": "clause", "offset": [91, 103]}, {"key": "to-the-extent", "type": "clause", "offset": [104, 117]}, {"key": "to-ensure", "type": "clause", "offset": [128, 137]}, {"key": "product-traceability", "type": "clause", "offset": [138, 158]}, {"key": "the-records", "type": "clause", "offset": [160, 171]}, {"key": "period-of", "type": "definition", "offset": [275, 284]}, {"key": "readily-available", "type": "definition", "offset": [366, 383]}, {"key": "each-order", "type": "clause", "offset": [416, 426]}, {"key": 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