General Terms and Conditions

For business customers

Effective: 28 September 2026

§ 1 Scope and contracting parties

  1. These General Terms and Conditions ("Terms") apply to all offers, deliveries and services by HiPer Medical AG ("HiPer Medical") to businesses within the meaning of section 14 of the German Civil Code (BGB), legal entities under public law and special funds under public law ("Customer"). They also apply to future business relationships if the Customer was informed of their application no later than the conclusion of the relevant contract and had a reasonable opportunity to review them.
  2. HiPer Medical objects to conflicting or supplementary terms of the Customer. Such terms become part of a contract only if HiPer Medical expressly agrees to them in text form. Performance without reservation does not constitute agreement.
  3. Individually agreed terms, including order confirmations, quality agreements, specifications and OEM agreements, prevail over these Terms within their respective subject matter. Mandatory law remains unaffected.

§ 2 Offers, formation of contracts and scope of performance

  1. Offers by HiPer Medical are non-binding unless expressly designated as binding or containing an acceptance period. A contract is formed by an order confirmation in text form or by performance of the order.
  2. The expressly agreed specifications govern type, quantity, quality, intended purpose, documentation and scope of delivery. Catalogues, samples, illustrations, technical information and advertising establish an agreed quality or a guarantee only if expressly confirmed by HiPer Medical. Deviations are permitted only to the extent legally permissible, technically necessary and reasonable for the Customer in view of the agreed intended purpose.
  3. Changes to specifications, quantities or dates after conclusion of the contract require agreement in text form. Before implementation, HiPer Medical may submit resulting, demonstrable additional costs and scheduling consequences for agreement. In the absence of agreement, the original contract remains applicable.
  4. Advice and technical recommendations do not relieve the Customer of assessing suitability for its specific intended application. HiPer Medical's statutory duties, particularly as a manufacturer of a medical device, remain unaffected.

§ 3 Custom manufacture, OEM and regulatory responsibilities

  1. For custom-made and OEM projects, the Customer provides agreed complete and accurate specifications, drawings, approvals and other required cooperation in due time. HiPer Medical reviews them to the extent of its contractual and statutory duties. If either party identifies a discrepancy, safety risk or possible non-compliance, it promptly informs the other party and coordinates further action.
  2. Before an OEM project starts, the parties specify in a separate agreement in particular which party acts as manufacturer, importer, distributor or other economic operator; which party is responsible for technical documentation, labelling, instructions for use, clinical evaluation, conformity assessment, post-market surveillance and vigilance; and which information and deadlines apply to incident reports and recalls. Such an agreement cannot override mandatory statutory duties towards authorities or third parties.
  3. The Customer may alter products, packaging, labelling or instructions for use only within the agreed and legally permissible use. It promptly informs HiPer Medical of serious incidents, safety risks, authority measures and relevant complaints of which it becomes aware, and reasonably assists with required investigations and safety measures. Each party's statutory reporting duties remain unaffected.
  4. The Customer warrants that materials and instructions provided by it do not infringe third-party rights. It indemnifies HiPer Medical against third-party claims to the extent caused by an infringement for which the Customer is responsible. HiPer Medical informs the Customer of any such claim and allows it reasonable involvement in the defence. The indemnity does not cover HiPer Medical's own fault or mandatory statutory responsibility.

§ 4 Prices and payment

  1. The prices agreed in the contract apply. Unless otherwise agreed, prices are net of statutory VAT and separately agreed shipping, packaging, customs and insurance costs. Export and import charges follow the agreed delivery term; in its absence, statutory rules apply.
  2. Unless another payment period is agreed, invoices are due without deduction upon receipt. Discounts require express agreement.
  3. In the event of late payment, statutory default interest and the statutory lump-sum compensation apply. HiPer Medical reserves the right to claim further loss caused by delay; any statutory lump sum is credited against recoverable debt collection costs.
  4. The Customer may set off claims that are undisputed, finally adjudicated or ready for decision. Set-off against claims arising from the same contractual relationship and statutory rights of retention remain unaffected.
  5. If circumstances becoming known after conclusion of the contract materially jeopardise the Customer's ability to pay, HiPer Medical may request appropriate security or advance payment and withhold its performance in accordance with statutory law.

§ 5 Delivery, dates and passing of risk

  1. Place of delivery, delivery term and any Incoterms are set out in the relevant contract. Where an Incoterms rule is used, the expressly agreed version applies. In the absence of an agreement, place of performance, shipping costs and passing of risk follow statutory law.
  2. Delivery dates are binding if expressly agreed as binding. Their observance presupposes timely performance of the Customer's agreed cooperation and payment duties. HiPer Medical promptly notifies the Customer of delays. The Customer's statutory rights in the event of delay remain unaffected.
  3. Reasonable partial deliveries are permitted if they are usable by the Customer in view of the contractual purpose and do not cause it significant additional costs.
  4. If the Customer defaults in accepting delivery or delays required cooperation, HiPer Medical may claim reasonable and proven additional costs caused thereby in accordance with statutory law. Further statutory rights remain unaffected.

§ 6 Retention of title

  1. HiPer Medical retains title to delivered movable goods until the purchase price under the relevant contract has been paid in full. Statutory rights in the event of late payment remain unaffected. HiPer Medical may demand return of goods solely on the basis of retention of title only where statutory requirements are met.
  2. The Customer handles goods subject to retention of title with due care and promptly informs HiPer Medical of attachments or other interventions by third parties. For cross-border deliveries, the parties cooperate in legally required and reasonable measures to protect an effectively agreed retention of title.

§ 7 Inspection, defects and subsequent performance

  1. At the time risk passes, the goods must have the agreed quality and comply with mandatory legal requirements applicable to them. Statutory remedies for defects remain in force subject to the following provisions.
  2. Where the sale is a commercial transaction for both parties, the inspection and notice duties under section 377 of the German Commercial Code (HGB) apply. This does not affect the duty to promptly report safety incidents and complaints relevant under applicable regulatory law.
  3. The Customer describes an alleged defect in sufficient detail and provides HiPer Medical with the information and affected goods required for assessment, to the extent legally permissible and possible in compliance with safety and hygiene requirements. HiPer Medical bears the statutory costs of justified subsequent performance.
  4. The form of subsequent performance and the Customer's further rights are governed by statutory law. A guarantee is given only by an express declaration identified as such. Rights arising from fraudulently concealed defects or an assumed guarantee of quality remain unaffected.
  5. Limitation periods for defect claims follow statutory law unless the relevant contract contains an effective different provision.

§ 8 Liability

  1. HiPer Medical is liable without limitation for intent and gross negligence, culpable injury to life, body or health, under the German Product Liability Act, for fraudulently concealed defects and to the extent of an expressly assumed guarantee.
  2. For a slightly negligent breach of a material contractual duty, HiPer Medical is liable for the damage foreseeable and typical for the contract when it was concluded. A duty is material if its performance makes proper performance of the contract possible and the Customer may regularly rely on its fulfilment. Otherwise, liability for slightly negligent breaches is excluded to the extent permitted by law.
  3. The preceding provisions also apply for the benefit of HiPer Medical's legal representatives, employees and vicarious agents. Mandatory claims, including those arising under medical device law, remain unaffected.

§ 9 Force majeure and unforeseeable impediments

  1. If a party is prevented from performing by an event outside its reasonable control that was unforeseeable when the contract was concluded and for which it is not responsible, the affected performance duties are suspended for the duration and extent of the impediment. The party promptly informs the other party insofar as possible and takes reasonable steps to limit its effects. Payment obligations already incurred remain payable.
  2. If the impediment lasts more than 60 calendar days and it is unreasonable for a party to remain bound to the affected part of the contract, that party may withdraw from that part after reasonable prior notice. Statutory rights remain unaffected. Irrespective of this, the parties coordinate measures necessary to protect medical devices already delivered or placed on the market.

§ 10 Intellectual property, documents and confidentiality

  1. Rights in pre-existing drawings, processes, software, tools, data and other know-how remain with the party entitled to them. Transfer of usage rights or ownership in specifically developed results, tools or moulds requires a separate agreement. Payment of development or tooling costs alone does not transfer any further rights.
  2. Each party keeps technical, commercial and regulatory information of the other party confidential if marked confidential or clearly recognisable as such, and uses it solely to perform the contract. This does not apply to information demonstrably in the public domain, lawfully obtained from third parties, independently developed or required to be disclosed by law or an authority. In the latter case, the disclosing party informs the other party beforehand to the extent legally permissible.
  3. The confidentiality duty continues for three years after the contract ends. Trade secrets remain protected as long as they meet the statutory requirements for protection. Mandatory documentation, retention, information and reporting duties remain unaffected.

§ 11 Export control and international delivery

  1. Each party complies with export control, sanctions, customs and import rules applicable to it. The Customer provides available information on end use, end user and destination country in due time to the extent such information may lawfully be requested for the agreed delivery.
  2. Neither party is required to perform an obligation to the extent performance would violate mandatory law or a binding order of an authority. It promptly informs the other party to the extent legally permissible and coordinates a lawful solution. Statutory rights to withdraw and claim damages remain unaffected.

§ 12 Governing law, jurisdiction and contract language

  1. German law governs the contractual relationship, excluding the United Nations Convention on Contracts for the International Sale of Goods (CISG). Mandatory rules applicable irrespective of this choice of law remain unaffected.
  2. To the extent a choice of court agreement is permissible under section 38 of the German Code of Civil Procedure (ZPO) and applicable international rules of jurisdiction, the courts at HiPer Medical's registered office have exclusive jurisdiction over disputes arising from the relevant contract. Mandatory exclusive jurisdictions remain unaffected.
  3. The contract language agreed in the relevant contract applies. In the event of a bilingual version of these Terms, the German version prevails unless the parties agree otherwise or mandatory law provides otherwise.

§ 13 Final provisions

  1. Legally relevant notices and declarations relating to the contract should be made in text form unless a stricter form is required by law. Proof of an individual agreement remains possible.
  2. If a provision of these Terms is or becomes invalid, the applicable statutory rule takes its place. The remaining provisions remain unaffected.