These General Terms and Conditions shall apply to all present and future business relationships between Endodirect GmbH & Co. KG, Am Neuweiher 13, 91564 Neuendettelsau, Germany (hereinafter “Endodirect”) and its customers, provided that such customers are entrepreneurs within the meaning of Section 14 of the German Civil Code (BGB), legal entities under public law, or special funds under public law.

These General Terms and Conditions shall apply exclusively. Any differing, conflicting or supplementary general terms and conditions of the customer shall become part of the contract only if and to the extent that Endodirect has expressly agreed to their applicability in text form. This requirement of consent shall apply in any case, even if Endodirect performs deliveries or services to the customer without reservation while being aware of the customer’s general terms and conditions.

Individual agreements with the customer, including ancillary agreements, supplements and amendments, shall take precedence over these General Terms and Conditions. Subject to proof to the contrary, a written contract or confirmation by Endodirect in text form shall be decisive for the content of such agreements.

These General Terms and Conditions, in the version valid at the time of conclusion of the contract, shall also apply to all future transactions with the customer without the need for any renewed express agreement.

Any business relationship with consumers within the meaning of Section 13 BGB is excluded.

Offers made by Endodirect are subject to change and non-binding unless they are expressly designated as binding.

Orders, instructions and other declarations made by the customer shall constitute a binding offer to enter into a contract. Endodirect shall be entitled to accept such offer within a reasonable period of time, but no later than within 14 calendar days from receipt, by sending an order confirmation in text form, by performing the delivery or service, or by issuing an invoice.

Automated acknowledgements of receipt, confirmations of receipt, or system-generated notifications shall not constitute acceptance in the legal sense.

The order confirmation issued by Endodirect, these General Terms and Conditions, and any expressly incorporated annexes, service descriptions or offers shall be decisive for the content of the contract.

All agreements, ancillary agreements and amendments to the contract shall require at least text form. This shall also apply to any waiver of this text form requirement.

Statements made by Endodirect regarding the subject matter of the delivery or service, in particular dimensions, weights, illustrations, technical data, performance characteristics, specifications and other descriptions, shall be approximate only unless exact conformity is mandatorily required for usability for the contractually intended purpose or a specific quality has been expressly agreed.

Obvious errors, in particular clerical, calculation, costing or transmission errors, shall entitle Endodirect to rescind the declaration. Any consideration already provided shall in such case be refunded without undue delay.

The conclusion of the contract shall be subject to correct and timely self-supply by upstream suppliers, provided that Endodirect has entered into a congruent covering transaction and the failure of supply is not attributable to Endodirect. Endodirect shall inform the customer without undue delay of any non-availability and shall refund any consideration already provided without undue delay.

Delivery periods and delivery dates shall only be binding if they have been expressly confirmed by Endodirect in text form. Insofar as no binding delivery period has been agreed, delivery or performance shall be made within a reasonable period of time.

Compliance with agreed delivery periods shall be subject to the timely and proper fulfillment by the customer of all duties to cooperate, provide materials and make payment. This shall apply in particular to the timely clarification of all technical and commercial issues, the provision of required documents, permits, approvals or specifications, and, where applicable, receipt of agreed advance payments.

Endodirect shall be entitled to make partial deliveries and render partial services, provided that these are reasonable for the customer.

Delivery periods shall be extended as appropriate in the event of circumstances for which Endodirect is not responsible, in particular force majeure, war, terrorism, pandemics, epidemics, governmental measures, import or export restrictions, shortages of energy or raw materials, labor disputes, operational disruptions, transport obstacles, disruptions in the supply chain, or failure of self-supply, incorrect self-supply or untimely self-supply. This shall also apply if such circumstances occur at upstream suppliers or subcontractors.

Endodirect shall inform the customer within a reasonable period of time of the beginning and end of such obstacles. If an impediment to performance lasts longer than 90 calendar days, both parties shall be entitled to withdraw from the contract with respect to the part not yet performed. No further claims shall exist in this respect; any consideration already provided for unperformed services shall be refunded without undue delay.

If Endodirect is in delay of delivery, the customer may withdraw from the contract only after setting a reasonable grace period in text form, provided that such grace period has expired unsuccessfully. As a rule, the grace period should be at least 14 calendar days unless, due to the circumstances of the individual case, a shorter period is appropriate.

Claims for damages due to delay in delivery shall, to the extent permitted by law, be limited in accordance with Section 5.

If dispatch, acceptance or handover is delayed for reasons for which the customer is responsible, Endodirect shall be entitled to store the goods at the customer’s cost and risk. Upon commencement of storage, the service shall be deemed rendered; further statutory claims of Endodirect shall remain unaffected.

Unless otherwise agreed, delivery shall be made ex works, ex warehouse or from another place of dispatch designated by Endodirect.

The risk of accidental loss and accidental deterioration shall pass to the customer at the latest upon handover of the goods to the forwarding agent, carrier or other third party designated to carry out the shipment. This shall also apply if partial deliveries are made or if Endodirect has assumed other services such as shipping costs, delivery or installation.

Where acceptance is required, such acceptance shall be decisive for the transfer of risk. The customer may not refuse acceptance in the case of only insignificant defects.

If dispatch, acceptance or handover is delayed due to a circumstance the cause of which lies with the customer, the risk shall pass to the customer on the day on which the goods are ready for dispatch and Endodirect has notified the customer accordingly.

Shipment shall generally be uninsured and at the customer’s risk unless otherwise agreed.

Transport insurance shall only be taken out upon the customer’s express request and at the customer’s expense.

To the extent customary in trade or technically necessary, excess or short deliveries of up to 5% shall be permissible and shall be accepted by the customer, provided this is reasonable for the customer.

Endodirect shall have unlimited liability for damages resulting from injury to life, body or health caused by an intentional or negligent breach of duty by Endodirect, its legal representatives, executive bodies, employees or vicarious agents.

Endodirect shall have unlimited liability for other damages in cases of intent and gross negligence.

In the event of a slightly negligent breach of essential contractual obligations, the fulfillment of which is indispensable for the proper performance of the contract and on the observance of which the customer may regularly rely (so-called cardinal obligations), Endodirect’s liability shall be limited to the damage typical for the contract and foreseeable at the time of conclusion of the contract.

In all other respects, Endodirect’s liability for slightly negligent breaches of duty shall be excluded to the extent permitted by law.

To the extent permitted by law, Endodirect shall not be liable for indirect damages, consequential damages, pure financial losses, loss of profit, lost savings, production losses, business interruptions, loss of use, financing costs, recourse claims by third parties, or any other damages not directly incurred to the subject matter of the delivery or service itself.

Endodirect shall be liable for loss of data only insofar as the damage would also have occurred if the customer had performed proper, regular data backup in accordance with the state of the art. Liability in this respect shall be limited to the typical restoration effort.

Endodirect shall not be liable for damages resulting from improper use, faulty or incomplete installation, lack of or inadequate maintenance, natural wear and tear, failure to observe operating, safety or manufacturer’s instructions, unsuitable operating conditions, impermissible interventions, modifications or repairs by the customer or third parties, or other circumstances for which Endodirect is not responsible.

The services of Endodirect are limited to the technical repair, inspection and, where agreed, delivery of devices and accessories. No medical treatment success or specific medical effect is owed. Responsibility for the selection, integration, validation, application, reprocessing, the specific clinical use and the operation of the devices shall lie exclusively with the customer or the respective user. The statutory warranty rights in the event of purchase contracts and the obligation to carry out repair services professionally shall remain unaffected.

To the extent Endodirect’s liability is excluded or limited, this shall also apply in favor of Endodirect’s legal representatives, executive bodies, employees and vicarious agents.

Liability under mandatory statutory provisions, in particular under the German Product Liability Act, as well as in cases of fraudulent concealment of a defect, assumption of a guarantee, or any other mandatory statutory liability, shall remain unaffected.

For new devices and new goods, the statutory warranty rights shall apply subject to the proviso that the limitation period for warranty claims shall, to the extent permitted by law, be reduced to twelve (12) months from delivery.

For used devices and used goods, liability for material defects shall be excluded to the extent permitted by law.

Quality specifications, product descriptions, illustrations, reference data, catalogue data, internet presentations, manufacturer’s information or other public statements shall not constitute a guarantee or an agreement on quality unless expressly designated or agreed as such in text form.

In the event of a defect, Endodirect shall initially be entitled, at its own discretion, to provide subsequent performance by remedying the defect or making a replacement delivery. Endodirect shall be entitled to make the subsequent performance owed dependent on the customer paying the purchase price due; however, the customer shall remain entitled to retain a part of the purchase price that is reasonable in proportion to the defect.

The customer shall inspect the goods carefully without undue delay after delivery. Obvious defects, wrong deliveries and quantity deviations must be notified in text form no later than within five (5) working days after delivery; hidden defects must be notified in text form without undue delay after discovery. Section 377 of the German Commercial Code (HGB) shall remain unaffected.

If proper and timely notice is omitted, the goods shall be deemed approved unless a defect was not discernible during inspection.

Warranty claims shall in particular not exist in cases of unsuitable or improper use, natural wear and tear, faulty handling, faulty assembly or commissioning by the customer or third parties, unsuitable operating materials, inadequate maintenance, omitted calibration, non-reproducible software errors, interventions by third parties, or other circumstances for which Endodirect is not responsible.

If subsequent performance fails or is unreasonable for the customer, the customer may, in accordance with the statutory provisions, withdraw from the contract or reduce the purchase price. Claims for damages shall be governed exclusively by Section 5 of these General Terms and Conditions.

If the examination of a notice of defect shows that no defect attributable to Endodirect exists, Endodirect shall be entitled to charge the customer for the inspection, processing, packaging, transport and shipping expenses incurred in accordance with the rates applicable at the time.

Returns, exchanges, credit notes or goodwill arrangements shall be made exclusively on a voluntary basis and without acknowledgment of any legal obligation, provided that no defect attributable to Endodirect exists. This shall apply in particular to sterile-packed or sealed products if the packaging has been opened, damaged or the resaleability has otherwise been impaired.

The goods delivered shall remain the property of Endodirect until full payment of all present and future claims of Endodirect arising from the ongoing business relationship with the customer (extended retention of title).

The customer shall be obliged to treat the reserved goods with care and, insofar as customary or requested by Endodirect, insure them adequately at its own expense against theft, breakage, fire, water and other damage.

The customer shall be entitled to resell the reserved goods in the ordinary course of business as long as the customer is not in default of payment and no application for the opening of insolvency proceedings over the customer’s assets has been filed. The customer hereby already assigns to Endodirect the claims arising from the resale against its buyers in the amount of the final invoice amount including VAT. Endodirect accepts this assignment.

The customer shall remain revocably authorized to collect the claims assigned to Endodirect. Endodirect may revoke this collection authorization if the customer fails to duly meet its payment obligations, becomes insolvent, or if any other good cause exists.

At Endodirect’s request, the customer shall disclose the assigned claims and their debtors, provide all information necessary for collection, hand over the associated documents, and notify the debtors of the assignment.

The customer shall not be permitted to pledge the reserved goods or assign them by way of security. In the event of attachments, confiscations or other interventions by third parties, the customer shall notify Endodirect without undue delay in text form and take all measures necessary to protect Endodirect’s rights.

Any processing, transformation or combination of the reserved goods by the customer shall always be carried out for Endodirect as manufacturer, without imposing any obligation on Endodirect. If the reserved goods are processed, combined or mixed with other items not belonging to Endodirect, Endodirect shall acquire co-ownership in the new item in the ratio of the invoice value of the reserved goods to the value of the other processed or combined items at the time of processing or combination.

At the customer’s request, Endodirect undertakes to release the securities to which it is entitled insofar as the realizable value of the securities exceeds the claims to be secured by more than 10%; the selection of the securities to be released shall be at Endodirect’s discretion.

In the event of conduct by the customer in breach of contract, in particular default in payment, Endodirect shall be entitled, after setting a reasonable grace period, to take back the reserved goods or demand their return. A demand for return shall not at the same time constitute withdrawal from the contract unless Endodirect expressly declares this.

Unless otherwise agreed, all prices shall be ex works or ex warehouse plus statutory VAT, packaging, transport, insurance, customs duties, import charges, assembly, installation, travel expenses, expenses and any other incidental costs.

The prices stated in the order confirmation or, if no such confirmation exists, those stated in Endodirect’s invoice shall be decisive.

Invoices shall be due for payment immediately without deduction unless otherwise agreed.

Payments shall only be deemed made upon final and unconditional crediting to Endodirect’s account.

If the customer defaults in payment, Endodirect shall be entitled to charge default interest at the statutory rate as well as the statutory lump-sum default fee and further damages for default.

Endodirect shall be entitled to render or provide outstanding deliveries or services only against advance payment, provision of security, or concurrent performance if, after conclusion of the contract, circumstances become known which are capable of substantially reducing the customer’s creditworthiness and by which payment of outstanding claims appears to be jeopardized.

Payments shall be made in due time irrespective of any notices of defects or counterclaims, unless a statutory right to refuse performance exists.

The customer shall only be entitled to set-off insofar as its counterclaims are undisputed, ready for decision, or have been finally adjudicated.

The customer shall only be entitled to exercise a right of retention insofar as its counterclaim is based on the same contractual relationship.

By sending in, handing over or otherwise making a device available, the customer commissions Endodirect with the technical incoming inspection, defect analysis, determination of condition and—unless expressly agreed otherwise—the preparation of a quotation.

The customer warrants that it is authorized to place the order and that the device sent in is free of third-party rights which conflict with the performance of the repair order, the return shipment, storage or, where applicable, disposal.

Quotations and other price indications of Endodirect shall be binding for a period of four (4) weeks from the date of issue, unless a different binding period is specified in the quotation.

Unless the customer expressly specifies otherwise, a repair order of up to a net repair value of EUR 1,500.00 per device shall be deemed to have been granted in advance upon submission of the device. In such case, Endodirect shall be entitled to carry out the repair without any separate further approval from the customer.

In the case of a repair order already approved, additional costs of up to 15% of the net repair value stated in the quotation shall be deemed approved, provided that such additional costs are technically necessary, objectively justified and reasonable for the customer for the proper performance of the repair. Endodirect shall inform the customer without undue delay of any additional costs beyond this and shall obtain separate approval prior to carrying them out.

Repair periods shall only be binding if they have been expressly confirmed as binding in text form. Information on estimated repair times shall be non-binding planning values.

Endodirect shall be entitled, for the performance of inspection, maintenance or repair services, to use suitable spare parts, exchange parts, refurbished components or functionally equivalent components, provided that this is reasonable for the customer and does not conflict with any expressly agreed quality.

If, after the defect analysis has been carried out and a quotation has been prepared, the customer does not place a repair order, Endodirect shall be entitled to charge a lump sum currently amounting to EUR 198.00 net per device for the inspection, analysis, administrative and processing effort incurred, provided that such remuneration has been agreed with the customer.

Endodirect reserves the right to adjust the lump sum referred to in paragraph 8 at its equitable discretion (Section 315 BGB) with effect for future cases, insofar and to the extent that the costs relevant to the rendering of the service, in particular personnel, inspection, diagnosis, administration, energy, material, disposal or logistics costs, increase or decrease. Any adjustment shall only be made to the extent that the underlying costs actually change; cost reductions shall be taken into account according to the same standards. The current lump sum shall be communicated to the customer upon request.

If no repair order is placed, the device sent in shall be returned to the customer unrepaired. In such case, Endodirect shall be entitled, in addition to the lump sum agreed pursuant to paragraph 8, to charge the return shipping costs and any other necessary expenses separately.

If no response is received within four (4) weeks after a request for approval, collection or any other declaration by the customer, Endodirect shall be entitled, after two unsuccessful requests in text form, to store the device at the customer’s cost and risk. If the customer also fails to respond after a further reasonable grace period and does not collect the device, Endodirect shall be entitled, in accordance with the statutory provisions, to realize the device or, where realization is not possible or economically unreasonable, to dispose of it. Statutory claims for remuneration, reimbursement of expenses and damages shall remain unaffected.

If the customer fails to collect a repaired device, a device made available for collection, or a device approved for return shipment in due time, or refuses to accept it, Endodirect shall be entitled to charge reasonable storage costs, handling charges and any further additional expenses.

If Endodirect provides the customer with a loan device, exchange device or replacement device for the duration of the repair, such device shall remain the property of Endodirect or the respective owner and must be treated with care and used exclusively for its intended purpose.

The loan device, exchange device or replacement device must be returned to Endodirect no later than within three (3) working days after receipt of the repaired device or, if no repair order is placed, after request by Endodirect, unless expressly agreed otherwise. Upon expiry of this period, the customer shall be in default of return.

For the delayed return of a loan device, exchange device or replacement device, Endodirect shall be entitled to charge a usage fee of EUR 89.00 net per calendar day.

Endodirect reserves the right to adjust the usage fee referred to in paragraph 15 at its equitable discretion (Section 315 BGB) with effect for future cases of provision, insofar and to the extent that the costs relevant to the provision and maintenance of loan devices, exchange devices or replacement devices, in particular acquisition, replacement, financing, storage, maintenance, repair, logistics, insurance or cleaning costs, increase or decrease. Any price adjustment shall only be permissible to the extent that the aforementioned costs actually change; cost reductions shall be taken into account according to the same standards. The current usage fee shall be communicated to the customer upon request.

If the customer returns a loan device, exchange device or replacement device damaged, incomplete, contaminated, or in a condition exceeding contractual wear and tear, Endodirect shall be entitled to charge separately for the resulting repair, replacement, cleaning, inspection, transport and other consequential costs. The assertion of further damages remains reserved; the customer shall remain entitled to prove that no damage at all occurred or that the damage was substantially lower.

If Endodirect provides services at the customer’s premises within the scope of service, maintenance or repair work, the customer shall, at its own expense, ensure safe and unobstructed access, the required connections, working conditions, safety precautions, and the cooperation of qualified personnel.

The customer shall be solely responsible for compliance with all legal, official, regulatory and professional provisions applicable to it, in particular in connection with the operation, application, reprocessing, validation, documentation, operator responsibility and placing on the market of medical devices and other equipment.

The customer shall ensure that any equipment sent in is properly decontaminated, disinfected, sterilized if necessary, and safely prepared for transport, testing, and processing. The customer must expressly inform Endodirect of any existing risks of contamination, infection, hazardous materials, radiation, or other hazards before sending the equipment in.

Endodirect shall be entitled to reject devices that have not been properly prepared, are contaminated, or cannot be handled safely for safety reasons, to return them untreated, or to have them decontaminated, inspected, secured or disposed of by a suitable third party at the customer’s expense, insofar as this is legally permissible and objectively necessary.

The customer shall be obliged to inspect devices on its own responsibility before commissioning, re-use or resale and to ensure that they are used exclusively by qualified and professionally instructed personnel.

Endodirect assumes no responsibility for the specific use of the devices in clinical, diagnostic, therapeutic or other practical operation by the customer or its end customers.

Insofar as special approval, registration, release, export, import, sanctions or documentation requirements exist for certain devices, components, software versions, series, types or manufacturers, the customer shall be responsible for independently reviewing and complying with them prior to ordering, export, transfer, commissioning or onward transfer.

The customer shall indemnify Endodirect against all claims asserted by third parties arising from a breach of the obligations set out in this Section 10, unless the customer is not responsible for the breach of duty.

Endodirect reserves all ownership rights, copyrights, rights of use and other industrial property rights in and to all offers, quotations, drawings, illustrations, photographs, descriptions, inspection reports, calculations, technical documents, data, files and other information of a tangible or intangible nature.

Without Endodirect’s prior consent, the customer may neither reproduce nor make available to third parties the documents and information referred to in paragraph 1, nor use them for purposes other than those contractually intended.

Information marked as confidential by Endodirect or which by its nature is recognizable as confidential shall be treated confidentially by the customer and used only within the scope of the respective business relationship.

The confidentiality obligation shall not apply to information which the customer can prove was already lawfully known to it, has become publicly known without breach of any confidentiality obligation, becomes publicly known without breach of this agreement, or is lawfully disclosed to the customer by an authorized third party.

Statutory disclosure obligations shall remain unaffected. In such a case, the customer shall inform Endodirect in advance, to the extent legally permissible.

To the extent permitted by law, the place of performance for all deliveries, services and payments shall be Endodirect’s registered office.

To the extent permitted by law, the exclusive place of jurisdiction for all present and future claims arising out of and in connection with the business relationship shall be Ansbach. However, Endodirect shall also be entitled to sue the customer at the customer’s general place of jurisdiction.

The law of the Federal Republic of Germany shall apply exclusively, to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods (CISG).

Should any provision of these General Terms and Conditions be or become wholly or partially invalid, unenforceable or void, the validity of the remaining provisions shall remain unaffected. The statutory provision shall replace the invalid, unenforceable or void provision.

Wherever text form is required under these General Terms and Conditions, transmission by e-mail shall also suffice, unless mandatory law prescribes a stricter form.