Terms and conditions

Polaris Diagnostics Europe GmbH | In vitro diagnostics | Medical devices | Software & cloud services

Version: December 2025

Section 1 Scope

1.1 These general terms and conditions (GTC) apply to all business relationships between Polaris Diagnostics Europe GmbH, hereinafter referred to as 'Polaris', and the customer. They apply to the sale and delivery of in vitro diagnostic medical devices (IVD), instruments, test kits, consumables, software and cloud services.

1.2 These GTC apply exclusively. Deviating, conflicting or supplementary terms and conditions of the customer only become part of the contract if Polaris has expressly agreed to their application in writing.

1.3 These GTC also apply to all future transactions with the customer, insofar as these are legal transactions of a related nature.

1.4 Individual agreements made with the customer in a specific case (including collateral agreements, supplements and amendments) always take precedence over these GTC. A written contract or written confirmation from Polaris is decisive for the content of such agreements.

1.5 The offerings of Polaris are directed exclusively at entrepreneurs within the meaning of section 14 of the German Civil Code (BGB), legal entities under public law or special funds under public law (B2B). Consumer transactions within the meaning of section 13 BGB are excluded.

Section 2 Conclusion of contract

2.1 The presentation of products on the website, in catalogues, brochures or other advertising materials does not constitute a legally binding offer but a non-binding invitation to submit an offer.

2.2 By placing an order, the customer bindingly declares their intention to purchase the products ordered. Orders may be placed in writing, by email, via the website or by telephone.

2.3 The contract only comes into effect upon written order confirmation by Polaris or upon delivery of the goods. The automatic acknowledgement of receipt of an online order does not yet constitute acceptance of the offer.

2.4 Polaris reserves the right to reject orders without stating reasons, in particular where there are justified doubts about the customer's creditworthiness or in the event of supply shortages.

2.5 The customer is bound by their order for a period of 14 days. The contract may be concluded in German or in English.

Section 3 Prices and payment terms

3.1 The prices applicable at the time of the order in accordance with the current Polaris price list shall apply. All prices are in euros, plus statutory value added tax and any shipping costs.

3.2 Unless otherwise agreed, the purchase price is due for payment without deduction within 14 days of the invoice date. Receipt of payment by Polaris is decisive for determining whether payment was made on time.

3.3 In the event of late payment, Polaris is entitled to charge default interest at 9 percentage points above the applicable base rate. The right to claim higher damages caused by default remains reserved.

3.4 The customer has a right of set-off only if their counterclaims have been legally established, are undisputed or have been acknowledged by Polaris. The customer is entitled to exercise a right of retention only to the extent that their counterclaim is based on the same contractual relationship.

3.5 Polaris is entitled to require advance payment, a down payment or other security from new customers or where there are justified doubts about solvency.

3.6 Recurring services (subscriptions, software licences, cloud services, maintenance contracts) are invoiced in advance for the respective billing period unless otherwise agreed.

Section 4 Delivery and shipping

4.1 Delivery is made ex Polaris warehouse or directly from the manufacturer. Delivery dates and periods are binding only if Polaris has expressly confirmed them as binding in writing.

4.2 The risk of accidental loss and accidental deterioration of the goods passes to the customer upon handover to the forwarding agent, the carrier or the person otherwise designated to carry out the shipment.

4.3 Partial deliveries are permitted insofar as they are reasonable for the customer. Each partial delivery is deemed an independent transaction and may be invoiced separately.

4.4 If the customer is in default of acceptance or culpably breaches other duties to cooperate, Polaris is entitled to demand compensation for the resulting damage, including any additional expenses.

4.5 In the event of force majeure, operational disruptions, strikes, lockouts, official orders or other unforeseeable events, delivery periods are extended accordingly. Polaris will inform the customer of such impediments without undue delay.

4.6 Temperature-sensitive products (e.g. test kits, reagents) are shipped in compliance with the prescribed cold chain. On delivery, the customer must check integrity and temperature and report any defects without undue delay.

Section 5 Warranty and claims for defects

5.1 The customer's warranty rights require that they have duly complied with their statutory obligations to inspect the goods and give notice of defects pursuant to section 377 of the German Commercial Code (HGB). Obvious defects must be reported in writing without undue delay, at the latest within 7 working days of receipt of the goods.

5.2 In the case of justified claims for defects, Polaris is entitled to choose between rectification and replacement delivery. If subsequent performance fails, the customer may, at their discretion, demand a price reduction or withdraw from the contract.

5.3 The warranty period is 12 months from delivery unless a shorter shelf life is stated for the product. For test kits and consumables, the shelf life stated on the packaging applies.

5.4 The warranty does not apply in cases of improper storage, handling or use contrary to the instructions for use, unauthorised modifications or repairs by the customer or third parties, or normal wear and tear.

5.5 The warranty for IVD medical devices is limited to function in accordance with the specification. No guarantee is given for specific diagnostic results or clinical decisions.

Section 6 Liability and limitation of liability

6.1 Polaris is liable without limitation for damage arising from injury to life, body or health based on an intentional or negligent breach of duty, and for damage covered by liability under the German Product Liability Act.

6.2 For other damage, Polaris is liable only in cases of intent and gross negligence and in cases of culpable breach of material contractual obligations. Liability for breach of material contractual obligations is limited to the foreseeable damage typical for this type of contract.

6.3 Liability for indirect damage, consequential damage, loss of profit, loss of data or business interruption is excluded unless caused by intent or gross negligence.

6.4 Polaris is not liable for damage arising from incorrect diagnostic decisions where the product functioned properly. Responsibility for the clinical interpretation of diagnostic results lies solely with the healthcare professional.

6.5 The above exclusions and limitations of liability also apply for the benefit of the legal representatives, employees and vicarious agents of Polaris.

Section 7 Retention of title

7.1 The instruments delivered (in particular the Igloo Pro reader), accessories and all software licences remain the property of Polaris Diagnostics Europe GmbH until all outstanding claims have been paid in full.

7.2 Until payment in full, the customer receives only a revocable, non-transferable right to use the instrument, software and cloud services.

7.3 The customer is obliged to handle the goods subject to retention of title with care and to insure them adequately against fire, water and theft. Maintenance and inspection work must be carried out in good time.

7.4 In the event of seizure or other interventions by third parties, the customer must notify Polaris in writing without undue delay and point out the ownership of Polaris.

7.5 Further pledging or transfer by way of security of the goods subject to retention of title is not permitted without the prior written consent of Polaris.

Section 8 Rights of use for software & cloud services

8.1 Use of the software, cloud services and digital functions is permitted exclusively to customers who meet their contractual and financial obligations.

8.2 Polaris is entitled to restrict functions or access where this is necessary to protect legitimate interests, in particular in the event of late payment.

8.3 Cloud services are provided with an availability of 99.0 % on an annual average. Planned maintenance windows are announced at least 48 hours in advance and do not count as downtime.

8.4 The customer is responsible for the security of their access credentials. Polaris must be informed without undue delay if misuse is suspected.

8.5 Use of the software or cloud services beyond the contractually agreed scope (e.g. multiple users, additional devices) requires a separate licence agreement.

Section 9 Suspension in the event of late payment

9.1 If the customer is in default of payment for more than 14 days, Polaris is entitled, after written notice and on expiry of a period of 48 hours, to suspend access to the software, the cloud services or the use of the instrument in whole or in part.

9.2 The suspension serves solely to enforce legitimate payment claims and does not constitute a product defect or service failure.

9.3 Once all outstanding claims have been settled, access is restored without undue delay, at the latest within 24 hours.

9.4 During the suspension, the customer's contractual payment obligations remain in full force. The suspension does not release the customer from the obligation to pay ongoing charges.

9.5 Polaris is entitled to charge a reasonable processing fee for restoring access after a suspension.

Section 10 Withdrawal, reclaim & revocation of use

10.1 If, despite a reminder and notice of suspension, no payment is made within a further 14 days, Polaris is entitled to withdraw from the contract and to reclaim the instrument under the retention of title.

10.2 In this case, the right to use the software and cloud services expires automatically. The customer is obliged to surrender the instrument without undue delay.

10.3 Polaris is entitled to charge the customer for the costs incurred for retrieval, transport and administration.

10.4 In the event of withdrawal, Polaris is entitled to demand reasonable compensation for the use already made of the instrument.

10.5 The customer has no claim to reimbursement of amounts already paid insofar as these relate to services already rendered.

Section 11 Exclusion of return once medical devices have been put into operation

11.1 The instruments delivered are in vitro diagnostic medical devices pursuant to Regulation (EU) 2017/746 (IVDR). Return is excluded once the instrument has been put into operation or used with samples or test kits.

11.2 Taking back used medical devices is not permitted for reasons of safety, hygiene and regulatory compliance.

11.3 The customer cannot assert a right of return in the event of late payment. The payment obligation remains in full force.

11.4 Polaris may refuse unauthorised returns or dispose of them at the customer's expense.

11.5 Test kits and consumables are generally excluded from return unless there is a product defect.

11.6 The provisions of this section serve to protect public health and ensure regulatory compliance and are therefore mandatory.

Section 12 Product conformity and regulatory requirements

12.1 The in vitro diagnostic products distributed by Polaris comply with the requirements of Regulation (EU) 2017/746 (IVDR) and bear the CE marking in accordance with the applicable conformity assessment procedures.

12.2 The customer undertakes to use the products only in accordance with their intended purpose, the instructions for use and the applicable statutory provisions.

12.3 Before using the products, the customer is obliged to ensure that they hold the necessary permits, approvals and qualifications and that they comply with the regulatory requirements of their country.

12.4 If the products are exported to countries outside the EU, the customer is responsible for complying with the regulatory requirements applicable there. No guarantee is given as to the eligibility for approval in third countries.

Section 13 Vigilance and reporting obligations

13.1 The customer undertakes to inform Polaris without undue delay of serious incidents, malfunctions, quality defects or safety-relevant events in connection with the products.

13.2 In the case of incident reports, Polaris will inform and cooperate with the competent authorities in accordance with the requirements of the IVDR and the national reporting systems.

13.3 The customer supports Polaris in investigating incidents by providing relevant information, access to the products and samples concerned and documentation of the circumstances of use.

13.4 In the event of field safety corrective actions or recalls, the customer is obliged to cooperate with Polaris and to implement the measures ordered without undue delay.

Section 14 Quality assurance and documentation

14.1 The customer is obliged to use the products in accordance with the enclosed instructions for use and in compliance with good laboratory practice (GLP).

14.2 The customer carries out their own quality controls and documents these properly. Polaris provides quality control materials on request.

14.3 The customer retains all relevant records of batch traceability, test results and quality controls for at least the period prescribed by the applicable regulations.

14.4 On request, Polaris provides the customer with declarations of conformity, certificates of analysis, safety data sheets and other product documentation.

Section 15 Training and technical support

15.1 Polaris offers training on the proper use of the products. The type, scope and cost of training are agreed separately.

15.2 Technical support is available during normal business hours (Mon-Fri, 9:00-17:00 CET) by email and telephone. Extended support services can be agreed for an additional charge.

15.3 The customer ensures that only appropriately trained personnel operate the products. Passing training content on to third parties requires the prior consent of Polaris.

15.4 For instruments with a remote maintenance function, the customer may grant Polaris remote access for maintenance and support purposes. Remote access is activated only with the express consent of the customer.

Section 16 Maintenance and servicing

16.1 Polaris offers maintenance contracts for instruments with different scopes of service. Scope, cost and term are governed by separate maintenance contracts.

16.2 The customer is obliged to observe the regular maintenance intervals recommended by the manufacturer. Failure to do so may void warranty claims.

16.3 Repairs and maintenance work may be carried out only by Polaris or by service partners authorised by Polaris. Unauthorised interventions void the warranty.

16.4 Instrument repairs outside the warranty are invoiced on a time and materials basis in accordance with the price list in force, unless a maintenance contract is in place.

Section 17 Software updates and upgrades

17.1 For the duration of an active usage contract, Polaris provides software updates that include bug fixes and security updates.

17.2 Functional extensions (upgrades) may be subject to a charge. The customer is informed of available upgrades and may purchase them voluntarily.

17.3 The customer is obliged to install security-relevant updates promptly. Failure to install them may void the warranty for resulting malfunctions.

17.4 Polaris reserves the right to discontinue support for older software versions after reasonable notice.

Section 18 Data protection and data security

18.1 Polaris processes the customer's personal data exclusively within the framework of the applicable data protection regulations, in particular the GDPR, and in accordance with the privacy policy at www.polarisdx.net.

18.2 Where Polaris obtains access to personal patient data in the context of the cloud services, a separate data processing agreement pursuant to Article 28 GDPR is concluded.

18.3 Data stored in the cloud is hosted on servers within the European Union. Any transfer to third countries takes place only in compliance with the statutory requirements.

18.4 Polaris takes appropriate technical and organisational measures to protect data against unauthorised access, loss or destruction. The customer is responsible for the security of their access credentials.

18.5 After termination of the contract, customer data is retained in accordance with the statutory retention obligations and subsequently deleted, unless longer retention obligations apply.

Section 19 Secrecy and confidentiality

19.1 The parties undertake to treat all confidential information, trade secrets and know-how obtained in the course of the business relationship as strictly confidential and not to disclose it to third parties.

19.2 This obligation does not apply to information that is publicly known, was already known to the recipient, was lawfully obtained from third parties or must be disclosed by statutory or official order.

19.3 The confidentiality obligation continues after the end of the business relationship, for a period of at least five years.

Section 20 Intellectual property

20.1 All rights to trade marks, patents, copyrights, software, designs, know-how and other industrial property rights remain with Polaris or the respective rights holders.

20.2 The customer receives a non-exclusive, non-transferable right to use the software within the scope of the respective licence agreement. Sub-licensing, transfer or reproduction is prohibited without written consent.

20.3 Reverse engineering, decompilation or other attempts to determine the source code of the software are prohibited unless permitted by mandatory statutory provisions.

20.4 The customer may use Polaris trade marks and logos only with prior written permission and in accordance with the Polaris brand guidelines.

Section 21 Export control and sanctions

21.1 The customer undertakes to comply with all applicable export and import regulations as well as sanctions provisions of the EU, Germany and, where relevant, other applicable jurisdictions.

21.2 The customer warrants that the products delivered will not be exported directly or indirectly to countries subject to embargoes, or supplied to persons or entities on sanctions lists.

21.3 In the event of breaches of export control or sanctions regulations, the customer is solely liable for all resulting damage and indemnifies Polaris against all third-party claims.

Section 22 Contract term and termination

22.1 Purchase contracts for individual products end upon complete performance. Continuing obligations (software licences, cloud services, maintenance contracts) have the term specified in the respective contracts.

22.2 Unless otherwise agreed, continuing obligations are automatically extended by a further 12 months unless terminated with 3 months' notice to the end of the term.

22.3 The right to extraordinary termination for good cause remains unaffected. Good cause exists in particular in the case of material breaches of contract, insolvency, the opening of insolvency proceedings or a breach of regulatory requirements.

22.4 On termination or the end of the contract, all rights to use the software and cloud services expire. The customer may export their data within 30 days of the end of the contract.

22.5 Fees already paid for unused contract terms are not refunded unless the customer terminates for reasons for which Polaris is responsible.

Section 23 Dispute resolution and place of jurisdiction

23.1 The parties undertake to first seek an amicable settlement in the event of disputes arising from or in connection with this contract.

23.2 The exclusive place of jurisdiction for all disputes arising from this contractual relationship is the registered office of Polaris, provided the customer is a merchant, a legal entity under public law or a special fund under public law.

23.3 Polaris is also entitled to bring proceedings against the customer at the customer's general place of jurisdiction.

23.4 Participation in dispute resolution proceedings before a consumer arbitration board is neither provided for nor offered, as these GTC are directed exclusively at entrepreneurs.

Section 24 Applicable law

24.1 The law of the Federal Republic of Germany applies, excluding the UN Convention on Contracts for the International Sale of Goods (CISG) and the conflict-of-law rules of private international law.

24.2 Where mandatory provisions of the law at the customer's habitual residence provide more favourable terms for the customer, those provisions apply.

Section 25 Final provisions

25.1 Amendments and supplements to these GTC must be made in writing to be effective. This also applies to any waiver of this written form requirement.

25.2 Should individual provisions of these GTC be or become wholly or partly invalid or unenforceable, the validity of the remaining provisions is unaffected. The invalid or unenforceable provision is replaced by the valid and enforceable provision that comes closest to the economic purpose of the invalid provision.

25.3 Polaris reserves the right to amend these GTC at any time with effect for the future. Amendments are communicated to the customer in writing or by email at least 4 weeks before they take effect. If the customer does not object within 4 weeks of receipt of the notification, the amendments are deemed approved.

25.4 There are no verbal collateral agreements. All agreements are recorded in writing.

25.5 The German version of these GTC is authoritative. Translations are for information only and do not create any rights of their own.