Conditions of Purchase (01.08.2026)
I. General
The present General Conditions of Purchase (hereinafter “contract”) define the terms of purchase of goods and services (“goods”, “services” and/or “deliverables”) between RAUMEDIC INC (“RAUMEDIC”) and its suppliers, sellers, service providers or subcontractors as appropriate (hereinafter “Supplier”). These shall also apply to all future business relations, even if they are not expressly agreed again. Counter-confirmations of the Supplier with reference to its terms and conditions as well as the terms and conditions of the Supplier itself shall hereby be excluded. Deviations from these Terms and Conditions shall only be effective if confirmed by RAUMEDIC in writing.
It is understood that some of the data processing can be handled on behalf of Raumedic Inc. by Raumedic AG, in such cases the data will be processed in accordance with the provisions of the European General Data Protection Regulation, the Supplier shall be informed that RAUMEDIC processes the personal and company-related data required for the handling of the business relationship with the aid of electronic data processing. The Purchaser recognizes the “Data Protection Guideline for Customers and Suppliers” – retrievable here – as part of this contract.
The following ranking applies to :
particular/special conditions;
orders
the special business conditions for the purchase of plant, machinery, tooling and equipment (if appropriate)
the present General Terms and Conditions of Purchase
The supplier acknowledges that the "Declaration of Principles on Respect for Human Rights," and the "Supplier Code of Conduct," which can be found on RAUMEDIC’s website (Compliance at RAUMEDIC – RAUMEDIC), is part of the agreement.
II. Order and Order Confirmation
The orders awarded by RAUMEDIC are only valid if they are made in writing (electronic mail or via systems supported by RAUMEDIC) and are signed by an authorized representative of RAUMEDIC. Spoken agreements or orders made by phone must be confirmed in writing. Orders issued electronically do not need to be signed.
The Supplier must confirm the order in writing, within five business days, otherwise the order is deemed accepted. Acceptance of an order constitutes acceptance by the Supplier of these General Conditions of Purchase. The order confirmation must reproduce all the details of the order. In turn, modifications to RAUMEDIC orders are only classed as approved, if they are confirmed in writing by RAUMEDIC.
III. Delivery Time
Agreed delivery dates are binding and timely delivery is of the essence. RAUMEDIC can, at its sole discretion and on a case-by-case basis, grant a grace period.
Force majeure events as well as strikes, lock-outs, operational disruptions, of whatever type and whatever cause, as well as other such unforeseen events, which make the performance of the Contract significantly more difficult, give RAUMEDIC the right to postpone the acceptance terms or to terminate an order without the Supplier receiving and right to claim for losses. The Supplier must make known any such events immediately.
If the Supplier fails to deliver the goods by the agreed delivery date, except where such delay is due to RAUMEDIC or a force majeure event, RAUMEDIC shall be entitled to apply a late delivery penalty. The penalty shall accrue from the beginning of the second full week of delay and shall be calculated at one percent (1%) of the net price of the delayed goods for each commenced week of delay. RAUMEDIC may set off the amount of the accrued penalty against any sums payable to the Supplier under this Contract. The payment or deduction of such penalty shall not relieve the Supplier of its obligation to deliver the goods and shall be without prejudice to RAUMEDIC's other contractual remedies, except that the RAUMEDIC shall not recover the same loss twice.
Irrespective of the legal or above agreed rights of RAUMEDIC, the Supplier is obliged to inform RAUMEDIC immediately, when it is apparent that the Supplier cannot adhere to the delivery date. Supplier immediately informs RAUMEDIC of the updated delivery date.
IV. Delivery, Delivery Note and Invoice
The place of delivery is the address of the receiver specified in the order. Part-deliveries, over and under-deliveries are not permissible unless explicitly allowed by RAUMEDIC in writing and on a case-by-case basis.
Unless otherwise agreed in writing, shipping is in all cases at the expense and risk of the Supplier. Deliveries, other than those for which strictly freight-free delivery is agreed, must always be sent over the most economical routes. All additional costs resulting from these regulations as well as costs for carriage etc. at the dispatch location are not accepted.
Goods shall be suitably packed to withstand normal freight handling and to withstand periods of storage. If the goods are damaged due to inadequate packing, the damaged goods shall be repaired or replaced at the Supplier’s expense.
Goods deliveries by motor vehicle are only accepted during normal shipping and receiving hours. Whenever the Supplier is on RAUMEDIC's premises, Supplier shall abide by RAUMEDIC’s rules regarding safety and access to the facilities, as well as applicable laws and regulations.
The delivery note is to be enclosed with the goods consignment. The invoice is to be sent to the invoice address specified in the order. Delivery note and invoice must be provided with the RAUMEDIC order number. Any certificate (such as a certificate of conformity or certificate of analysis) must be included with the goods. Invoices are to be sent separately from the goods consignment as a single copy to RAUMEDIC.
V. Price
The agreed prices are fixed prices. They include freight, packaging and exempt from duty at the address of the recipient. Should it be necessary, to issue orders without a prior price agreement, then, in the case of an on-going business relationship, the prices of the previous order apply. Otherwise, Supplier’s price list, which was valid at the time of ordering, minus any agreed discount, applies; unless the list price at the time of fulfilment of the order by the supplier is more favorable to RAUMEDIC.
VI. Payment Terms and Conditions
The place of payment for all payments is Mills River, North Carolina.
Unless otherwise agreed, payments shall be made in net in 75 days, or with a 2% cash discount in 14 days, as of receipt of the goods or invoice. Payment by RAUMEDIC does not constitute acceptance of the goods or services. RAUMEDIC is entitled to hold back any payment in full or in part to clear any deficiencies or to fulfil other counter claims arising from the overall business relationship.
VII. Manufacturing Inspections, Notice of Defects
Through its works inspection, the supplier ensures that the deliverables meet the technical delivery conditions of RAUMEDIC. The Supplier undertakes that it will keep records of the executed inspections and archive all inspection, measurement and checking results for 10 years. RAUMEDIC is entitled at any time to inspect these documents and make copies.
RAUMEDIC shall inspect the supplied Goods only as regards quantity, item number and obvious damage in transit, and report any defects or discrepancies, within two weeks of receiving the goods. Hidden defects shall be reported to the supplier within five (5) business days of being discovered.
In the case of large quantities, the inspection of the goods by RAUMEDIC shall be limited to random samples. Defects not discovered as part of that shall be classed as hidden.
VIII. Guarantee and Warranty
The supplier shall assume a warranty of three (3) years as of the passage of risk for its deliverables and services to the effect that its deliverables and services during the warranty period shall be:
free from defects of any kind,fully suitable for the intended or agreed purpose,
only of materials and raw materials, that are suitable for the application in Medical Devices,
in accordance with the best demonstrated available technology, generally accepted technical, health safety and relevant medical and pharmaceutical regulations of authorities and professional associations and in accordance with the current legislation and regulations, and
the contractually agreed or warranted properties.
If the Supplier has provided or offered a longer or more extensive warranty or guarantee on its own initiative, this warranty/guarantee provided or offered by the Supplier shall apply. Any rights of recourse available under applicable law shall remain unaffected. The supplier shall indemnify RAUMEDIC against all claims of RAUMEDIC’s customer in relation to the warranty. The supplier shall also indemnify RAUMEDIC against any existing third-party claims.
If it has a claim under the warranty, RAUMEDIC shall be entitled in each case to either:
reduce its payment;
terminate the order with a full refund of the price paid by RAUMEDIC;
or demand new performance or services or rectification of defects or a replacement that is free of defects, including compensation for the installation and dismantling removal costs.
Supplier shall refund RAUMEDIC for all direct and indirect costs sustained by RAUMEDIC and resulting from the defects of goods or services, including those linked to voluntary or mandatory product recalls, corrections or removals, including those imposed by public authorities.
The rights and claims of RAUMEDIC arising from culpa in contrahendo ("fault in conclusion of a contract"), breach of contract, unlawful act, etc. shall remain unaffected. If defects are rectified or a replacement is delivered, the above warranty period shall begin anew for the entire delivery item, unless the defects were rectified out of goodwill or the defect is due to a cause other than the rectified defect. The supplier shall indemnify RAUMEDIC against all and any claims arising from legal liability for defective products under the applicable law.
If recalls or service actions occur due to problems with the Supplier's delivery items, then the supplier bears all costs arising insofar as the problems covered by the supplier. This also applies to costs charged to RAUMEDIC by its customers.
In urgent cases, RAUMEDIC shall be entitled to repair defects in a delivery item, or have them repaired, at supplier’s cost, or to procure replacement from a third party, without needing to notify the supplier in advance of the defect and how it is remedied.
An urgent case exists if there is:danger to life and limb,
imminent failure to deliver or delivery bottlenecks or
imminent damage exceeding ten (10) times the annual value of the goods procured by the supplier per calendar year.
The orders from RAUMEDIC assume that the Supplier has, to cover any possible product liability risk, ensured the product risk within the scope of his normal business liability insurance. RAUMEDIC can request to see any corresponding insurance policies.
Due to any payable or non-payable claims that RAUMEDIC makes against the Supplier is entitled to apply the right of retention (of goods) for settlement or enforcement purposes. RAUMEDIC may retain goods to settle or enforce any claims—whether payable or not—against the Supplier.
IX. Indemnification and Insurance
Supplier shall indemnify, defend, and hold harmless, RAUMEDIC, its Affiliates and RAUMEDIC’ successors and assigns (“RAUMEDIC Indemnified Parties”) from and against all liability, loss, damage, injury, action, claim or demand and charge, cost and expense, including but not limited to, attorneys’ fees, costs, internal processing expenses, rework and remanufacturing costs, sustained by or incurred by RAUMEDIC by reason of failure of the goods or the services to conform to the warranties contained herein or in an order or breach by the Supplier of any of its obligations hereunder or negligence or willful misconduct by it, its employees, representatives or agents. Such indemnity shall be in addition to any other remedies afforded by law, contract or equity and shall survive termination of the order.
Supplier shall indemnify, defend and hold harmless RAUMEDIC Indemnified Parties from and against any suit or proceeding that alleges or is based on a claim that the goods or any component part furnished hereunder, or the services, infringe any patent or other Intellectual Property rights of a third party. The Supplier shall pay all damages, costs and attorneys’ fees related to, or arising from, any such suit or proceeding and, at RAUMEDIC’s sole determination and discretion, either obtain the right for RAUMEDIC to continue to purchase and/or use the goods or the services; refund RAUMEDIC, rework the goods so as to make them non-infringing while preserving their original functionality; or replace them with goods that are functionally equivalent to the infringing goods.
The Supplier shall maintain, at its own expense and through a carrier with an A.M. Best rating of A- or better, insurance coverage with limits typically purchased by companies of similar size in the Supplier industry. The Supplier will provide RAUMEDIC with a certificate of insurance evidencing such coverage and will promptly furnish copies of endorsements and/or policies upon request. RAUMEDIC shall be informed of any cancellation or reduction in coverage with a minimum of sixty (60) days prior written notice.
X. Passing of Risk and Title
In all cases the risk and title pass to RAUMEDIC upon receipt of the goods by RAUMEDIC or at the specified place of delivery. This also applies if RAUMEDIC has accepted shipping costs in an individual case or delivery is "ex works". If payment for the goods is made prior to delivery, the title in the goods shall pass to RAUMEDIC once payment has been made.
XI. Means of Production, Drawings, Specifications
Production tools such as models, samples, dies, tooling, jigs, drawings, software, etc. (“Production Tools”), which are made available by RAUMEDIC to the supplier or are manufactured by the supplier according to the specifications of RAUMEDIC, may not be disposed of to third parties, bonded or forwarded for the use of third parties in any other way, without the consent of RAUMEDIC. The Production Tools become with their purchase or manufacture by the supplier, the property of RAUMEDIC. Supplier stores Production Tools for RAUMEDIC free of charge. The supplier must repair, maintain and, during the agreed service life, renew the Production Tools at its own expense .
The Production Tools shall be surrendered to RAUMEDIC upon its request, at the supplier's expense. The supplier must return the Production Tools to RAUMEDIC upon request, at the supplier’s expense.
The specifications drawn up by RAUMEDIC remain, even after transfer, the property of RAUMEDIC. They remain copyrighted to RAUMEDIC. Section XII, sub-section 1 applies to the content.
XII. Non-disclosure, Industrial Property Rights
The Supplier must treat all information obtained through the order or during visits—including manufacturing know‑how, drawings, orders, and business relationships—as confidential trade secrets and may not disclose them to any third party. All employees involved in fulfilling the order must be bound to the same confidentiality obligations and instructed accordingly. If the supplier uses subcontractors with RAUMEDIC’s prior approval, the Supplier must impose identical confidentiality obligations on them. The Supplier is liable for ensuring that through the delivery and use of the delivery items the industrial property of third parties is not infringed. He also guarantees that the ordered material is free from third party industrial property rights, in particular relating to production and use processes. Should the Supplier have his own industrial property in respect of the deliverables, he will inform RAUMEDIC in good time of such a fact. The same applies to third party industrial property. The Supplier undertakes to release RAUMEDIC from all possible third-party claims for damages. Know-how, other such knowledge etc. developed within the scope of an order as well as all rights thereto accrue to RAUMEDIC alone. The Supplier is not authorized to use this know-how or other knowledge for other customers without written consent.
Know‑how and other information developed in connection with the order, along with all related rights, belong exclusively to RAUMEDIC. The Supplier may not use this know‑how or information for any other customer without RAUMEDIC’s written consent. Insofar as the results of the work or parts thereof from individual orders are patentable, these new industrial property rights belong to RAUMEDIC alone.
XIII. Compliance requirements
The Supplier undertakes to inform RAUMEDIC in writing of all foreign trade master data specified below after RAUMEDIC places an order (e.g. in the order confirmation) and latest at the point of the delivery. In case of any changes RAUMEDIC will be promptly informed : (i) country of origin (non-preferential origin) according to the rules of origin from the World Customs Organization (WCO), (ii) a long-term vendor declaration (LTVD) for the preferential origin of goods, on request and if applicable, or any other document confirming the preferential origin status of the product (iii) a statistical goods number based on the tariff nomenclature from the World Customs Organization (WCO), (iv) Export Control Classification Number (ECCN) according to the EC-Dual-Use regulation (No. 428/2009 including latest updates) or comparable international lists, as well as an ECCN related to the US Export Administration Regulations (EAR) or any other applicable law or regulation, and (v) potential share of US components per product (de-minims rule) if applicable.
The Supplier must follow generally accepted engineering and industry standards, all applicable laws and regulations, and RAUMEDIC’s internal rules. Unless the order specifies otherwise, all goods and services must comply with recognized technical standards, including those of the Supplier’s upstream vendors, and—where applicable—equivalent U.S. standards such as ANSI, ASME, ASTM, NFPA, OSHA, EPA, or other relevant industry norms. The delivery items, as also the service, are respectively to be created and equipped, so that on the day of delivery, all valid legal and official regulations, including any equipment safety law and health & safety and environmental protection legislation are conformed to. In particular, the Supplier must observe the regulations and rules of the industrial injuries corporation, as well as the generally recognized safety technology and vocational health rules. Machinery and technical working materials are to be supplied conforming to the Machinery Ordinance with an EC conformity declaration including CE marking or a manufacturer's declaration; in addition an operating manual is to be enclosed. They must also conform to the standards in lists A and B of the "General Administrative Regulation for the Act on Technical Equipment" as well as other rules with safety-related content and the regulations and rules of the employer's liability insurance association. The Supplier must ensure that all goods and services comply, at the time of delivery, with all applicable safety, health, environmental, and medical‑device regulatory requirements. This includes compliance with OSHA workplace‑safety rules, EPA environmental regulations, and relevant U.S. industry standards such as ANSI, ASME, ASTM, NFPA, and UL. The supplier must also follow all generally accepted safety‑engineering and occupational‑health practices.
For medical‑device–related products or components, the Supplier must comply with ISO 13485 and FDA 21 CFR Part 820 (Quality System Regulation), including requirements for documentation, process controls, risk management, traceability, corrective and preventive actions, and any other obligations necessary to maintain conformity with RAUMEDIC’s quality system. Machinery and technical equipment must meet all applicable U.S. machinery‑safety regulations and include any required conformity statements, certifications, markings, and operating manuals. All items must also comply with any other relevant safety‑related rules and industry standards of the employer's liability insurance association.
If the Supplier delivers any substances classified as hazardous under applicable U.S. regulations—such as OSHA’s Hazard Communication Standard or EPA hazardous‑substance rules of Federal Hazardous Substances Act (FHSA)—or if the supplied products may release such substances during use, the supplier must provide the required Safety Data Sheet (SDS) in advance and without being asked. The use of carcinogenic substances by the supplier is prohibited unless expressly permitted by law and approved in writing by RAUMEDIC.
Supplier, its directors, officers, employees and agents must not undertake any activity that may constitute a breach of any provision of applicable anti-corruption laws such as the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions 1997 or the United Nations Convention against Corruption 2003
Unless exempt, the Supplier and its subcontractor shall abide by the requirements of 41 CFR §§ 60 1.4(a), 60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. If applicable, the contractor and subcontractor shall also abide by the requirements 41 CFR § 61-300.10 regarding veterans’ employment reports and 29 CFR Part 471, Appendix A to Subpart A regarding posting a notice of employee rights.
XIV. Termination
In the event of any default by the Supplier in the performance of any obligations, RAUMEDIC may, where such default is capable of remedy, give the Supplier written notice to rectify such default in a specified time. If the Supplier fails to comply with the requirements of the notice, or the default cannot be remedied, RAUMEDIC shall be entitled to terminate the order, in whole or in part, with immediate written notice to the Supplier, without prejudice to any other rights under the Order or otherwise.
RAUMEDIC shall be able to terminate the order if Supplier is bankrupt, applies for judicial or extra-judicial settlement with its creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the like) appointed by reason of its insolvency, or becomes the subject of liquidation or dissolution proceedings.
RAUMEDIC may terminate the order, for any reason or no reason, in whole or in part, with three (3) months’ notice to the Supplier. The Supplier shall cease all performance except to the extent provided in the notice of termination. In such event, RAUMEDIC shall make payment to the Supplier (as full and final settlement of all claims which the Supplier may have against RAUMEDIC as a result of termination) for all work satisfactorily performed up to the date of termination. This shall include all materials, which have been procured by Supplier for incorporation in the work and which cannot be used for a different customer.
Termination shall not relieve either Party of liability with respect to any breach or with respect to rights and obligations based upon any matter which occurred prior to termination.
XV. Assignment of Claim, Retention of Title, Charging, Court of Jurisdiction
The Supplier is not permitted, without prior consent, to assign his claims against RAUMEDIC or to permit them to be collected by third parties. If the Supplier assigns his claims against RAUMEDIC, to a third party without RAUMEDIC's consent, then the assignment is anyhow effective, RAUMEDIC can however, if it so desires act with releasing effect against the supplier or the third party. The Supplier may not assign its claims against RAUMEDIC or allow third parties to collect them without RAUMEDIC’s prior consent. If the Supplier assigns a claim without consent, the assignment is still legally valid; however, RAUMEDIC may choose to discharge its obligation by paying either the supplier or the third party.
The Supplier has no retention of title of any kind over the items it delivers. All items become RAUMEDIC’s property upon delivery. No liens of any type—including contractor’s liens—may arise.
The charging of counterclaims or the exercising of a right of retention against claims from RAUMEDIC is only permitted if the counterclaim has been acknowledged in writing or legally established.
RAUMEDIC is entitled to set off all claims, of whatever type, against all claims the supplier has against a company within the RAUMEDIC group, even when claims are at different stages. This right applies to all forms of setoff and recoupment permitted under applicable U.S. law.
The law of the State of Delaware applies. The application of the United Nations Convention on Contracts for the International Sale of Goods of 11.04.80 is excluded
This Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware.
The parties hereby irrevocably submit to the venue of the state and federal courts located in Henderson County, North Carolina for any dispute arising out of this Agreement; provided, however, that such venue shall be exclusive as to the Supplier only. Notwithstanding the foregoing, RAUMEDIC shall be entitled to bring an action against the Supplier in any other court of competent jurisdiction where venue may properly lie under applicable law.
XVI. Other Provisions
No party may assign its rights or obligations under any Order or under the contract without the prior written consent of the other party. Notwithstanding the foregoing, RAUMEDIC may assign its rights or obligations, without the Supplier's prior consent, if the assignment is in connection with a merger, reorganisation, consolidation or sale of substantially all of RAUMEDIC's assets, provided that such assignee assumes all of the obligations and liabilities of RAUMEDIC under the Contract. Subject to the foregoing, the provisions of any Order and the agreement shall apply to and inure to the benefit of the parties hereto and their respective successors and assignees.
The Supplier may use a subcontractor to supply the Goods or parts thereof only with the specific prior written consent of RAUMEDIC. Failure by the Supplier to obtain such prior consent before engaging a subcontractor shall constitute a material breach of the contract by the supplier. The Supplier shall be liable for the acts or omissions of its subcontractors as if they were its own acts or omissions, whether or not RAUMEDIC has consented to the Supplier's use of a subcontractor.
The Supplier acknowledges and agrees that the Supplier's commitment to quality is an essential requirement of RAUMEDIC. The supplier undertakes to continuously improve the quality of the production or development process for the Products. The Supplier undertakes to maintain the highest quality standards. RAUMEDIC, its representatives and/or its direct customer may, at any time, giving appropriate notification, conduct quality audits and quality control procedures of the Supplier's manufacturing facilities, as well as audits to assess the supplier's compliance with its obligations under this Section. Furthermore, subject to confidentiality provisions, the Supplier undertakes to provide RAUMEDIC with unrestricted access to all information relating to the Goods (other than financial records) and to provide RAUMEDIC with a copy of the relevant information.
The Supplier shall have an established change control and notification procedure to ensure that RAUMEDIC is notified in the event of any changes. This procedure shall allow full traceability of all established changes as well as evaluation of potential impact of the individual change. The Supplier shall notify RAUMEDIC of any permanent or temporary suspension or implementation of major changes in the production of Goods at least two (2) calendar years in advance by written notice to be countersigned by RAUMEDIC. Major changes shall be the following: (i) changes in the composition, source and grade of any raw material, (ii) changes in the method of production, processing, sterilization or testing that may affect form, fit or function of the supplied Goods (iii) changes of production location, (iv) changes in the specification of supplied Goods, and (v) changes of pre-suppliers. Before any minor changes are made, the supplier shall inform RAUMEDIC at least one (1) year in advance by written notice to be countersigned by RAUMEDIC. Minor changes shall be the following: (i) methods or equipment used for testing the Goods, (ii) any other quality assurance activities relating to the Goods, (iii) changes in the packaging storage and distribution conditions, if these have been agreed individually between the Parties for the Goods, (iv) changes in the labelling, specifically content, if these have been agreed individually between the Parties for the Goods. The Supplier shall produce enough unchanged goods to supply RAUMEDIC for a minimum period of twenty-four (24) months after implementation of the announced change.
Supplier agrees to continue to manufacture, or ensure a third party manufactures the Goods, including any spare parts and/or any element of the Goods for a minimum period of ten (10) years following their delivery. Supplier shall inform RAUMEDIC of total or partial interruption of production of Goods or performance of Services, with no less than two (2) years advance written notice. In the event of a total interruption, RAUMEDIC shall be afforded a “last time buy” of an amount no less than the average twelve (12) month purchasing history multiplied by the remainder of the continuity period. Supplier undertakes for the same ten (10) year period to supply technical assistance to RAUMEDIC on its first demand and to carry out maintenance of the supply. If Supplier intends to surrender manufacturing or sale of any goods, supplier shall inform RAUMEDIC hereof in writing without undue delay. RAUMEDIC shall have the preferred right, within six (6) months upon receipt of this notification, to assume the manufacturing and sale of the respective Goods against payment of a reasonable fee to be negotiated between the Parties hereto.