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OEM Agreement
Between the "OEM Supplier" Shenzhen XXX Technology Co., Ltd. Address: XXX Shenzhen, China and the "private label manufacturer" PT. XXX XXX Sulawesi – Indonesia Validity: This agreement is not valid for medical devices which are bought from the OEM Supplier from other OEM Suppliers (doubled OEM-PLM-constellation). Duration of validity: This agreement is valid from the last date of signing the Agreement (or the annex) for 5 years Goal of agreement: The OEM Supplier supplies OEM medical devices to the private label manufacturer, which the private label manufacturer will distribute under his own name as the responsible manufacture The annex of this Agreement lists these medical devices with compliance statement between original medical device to OEM medical device as well as all modifications between OEM medical device and private label medical device. This agreement governs the responsibilities of the parties and their cooperation. Archiving of documents and records: The complete technical documentations, all documents and all quality records on production, checks, traceability and sterilisation shall be archived by the OEM Supplier for a period of at least 5 years beyond the life of the products and 5 years after the production of the last product (or longer). The OEM Supplier is obligated to allow the competent authorities of the private label manufacturer to examine the complete technical documentations, all documents and all quality records on production, inspections, traceability and on request. These obligations of the OEM Supplier continue to apply even after the end of the contract relationship. Audits: The notified bodies of the private label manufacturer have the right to inspect all warehouses, production and testing facilities, which are associated with the products at any time. The OEM Supplier guarantees this right for all sub-contractors which are related to the products, too. By appointment, the private label manufacturer and his competent authorities have the right to inspect all warehouses, production and testing facilities, which are associated with the products. The OEM Supplier guarantees this right for all sub-contractors which are related to the products, too. Mutual Obligation to Provide Information: If serious defects are determined in a medical device already approved, then the OEM Supplier and private label manufacturer are both obligated to notify each other of this fact. The OEM Supplier shall immediately inform the private label manufacturer on essential technical modifications to the Original medical devices of the OEM Supplier including modifications with regard to the expansion or restriction of the intended purpose. For the clarification of all quality-relevant questions and problems, customer complaints, monitoring and reporting system, recalls, risk management, labelling, instructions for use, modifications and regulatory requirements, as well as questions on the Agreement, the following persons are specified by both parties: Private label manufacturer: PT. XXX XXX South Sulawesi – Indonesia OEM Supplier: Shenzhen XXX Technology Co., Ltd. Address: XXX Shenzhen, China These mutual obligations to provide information continue to apply even after the end of the contract relationship. Secrecy: Both parties shall be obligated to mutually keep all information conveyed to them from the respective contractual partner and the related samples confidential, not to make use of such information outside the agreement, nor to disclose it to third parties, nor to make use of this information as long as no other written agreement has been concluded in the individual case. These obligations shall remain to be valid even after termination of the Agreement. Maintaining the agreement: The accuracy and completeness of this agreement shall be checked by both parties periodically. Partial Invalidity: The effectiveness of the remaining provisions of this agreement shall not be affected in case individual parts of this quality assurance agreement become void for any legal reasons whatsoever.
------------------------------------------------------------------------------------------------------------------------------------------------ Annex to OEM Agreement of products between OEM Supplier Shenzhen XXX Technology Co., Ltd. and Private Label Manufacturer PT. XXX
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OEM Agreement 代工协议-印尼
涉外文件格式样本 | 2021-10-27 15:31OEM Agreement 代工协议-印尼