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Terms & Conditions (B2B)

Effective date: 

Company: [Company legal name], [registered address], FN [], Commercial Register Court: [], VAT ID: [ATU], Email: [], Phone: [].

1. Scope & Parties (B2B only)

1.1 These Terms apply to all quotations, orders, sales, deliveries, and services via this website to business customers only (entrepreneurs/“Unternehmer”). Orders by consumers are not accepted; consumer protection rules (e.g., withdrawal rights) do not apply.

1.2 Conflicting or additional customer terms are rejected unless expressly accepted in writing.

2. Regulatory Roles & Compliance (Medical Devices)

2.1 EU importer role (Austria entry): For products we bring from third countries into the EU, we act as importer and meet obligations under EU Medical Device Regulation (MDR) 2017/745 and/or IVDR 2017/746 (e.g., verifying CE/DoC, UDI/label/IFU, storage/transport per specs, incident and recall cooperation). You acknowledge and support these obligations where relevant. eur-lex.europa.eu+1medical-device-regulation.eu

2.2 Distributor role (your onward sales in the EU): If you resell, you act as distributor and must perform distributor checks and duties (Article 14 MDR/IVDR), including vigilance and cooperation in FSCA/recalls. medical-device-regulation.eu

2.3 Language & market requirements: You must ensure that labels/IFUs and marketing comply with the language and other rules of the Member State of destination; we can support translations by agreement. eur-lex.europa.eu

2.4 Traceability & vigilance: Maintain records (including UDI where applicable), report incidents and complaints promptly, and cooperate with any corrective actions or recalls. eur-lex.europa.eu

3. Website & Contract Formation

3.1 Website content is a non-binding invitation to treat.

3.2 A contract is concluded only upon written order confirmation or dispatch by us.

3.3 We may request proof of B2B status (e.g., VAT ID, trade register extract) before acceptance.

4. Prices, VAT & Invoicing

4.1 Prices are in EUR and exclude VAT, duties, and fees unless stated otherwise.

4.2 Intra-EU B2B supplies may be VAT-exempt if you provide a valid VAT ID and proof of transport meeting Art. 45a Implementing Reg. 282/2011 (as amended by Reg. 2018/1912) and the EU VAT Directive 2006/112/EC; otherwise VAT will be charged. eur-lex.europa.eu+2eur-lex.europa.eu+2

4.3 Invoices are due [__] days net from invoice date unless otherwise agreed.

5. Import, Customs & Export Controls

5.1 Importer of record (Austria): Where we import goods into Austria, customs clearance is handled under the Union Customs Code (Reg. 952/2013); related charges and fees may be recharged if agreed. eur-lex.europa.eu

5.2 Export controls & sanctions: Both parties comply with EU export control and dual-use rules (Reg. 2021/821) and applicable sanctions. Intra-EU transfers of certain Annex IV items may still require authorisation; you must not re-export in breach of applicable laws. eur-lex.europa.eu

6. Delivery, Risk & Time

6.1 Delivery terms are Incoterms® 2020 as specified in our offer or order confirmation; absent agreement the default is FCA [Vienna, AT] (Incoterms® 2020). ICC - International Chamber of Commerce

6.2 Risk passes per the agreed Incoterms rule (for FCA: upon handover to the first carrier at the named place). ICC - International Chamber of Commerce

6.3 Partial deliveries are allowed if reasonable. Delivery dates are estimates unless expressly guaranteed.

7. Retention of Title (Eigentumsvorbehalt)

7.1 Title to goods remains with us until full and final payment of all amounts due.

7.2 Until title passes, you shall store goods separately, keep them insured, and neither pledge nor transfer them as security.

7.3 In case of default/insolvency, we may repossess goods to which title is retained, without prejudice to damages. (Retention-of-title clauses are generally recognised in Austria.) www.advantageaustria.org

8. Inspection & Notification of Defects

8.1 You must inspect deliveries without undue delay after receipt and notify any apparent defects or shortages promptly in writing, with details and evidence.

8.2 Returns require our prior RMA and instruction.

8.3 Non-returnable: sterile/single-use/cold-chain and customised items are not returnable (except where mandatory law requires), and returned devices must meet storage/temperature requirements and be unopened/undamaged.

9. Warranty (Gewährleistung) & Support (B2B)

9.1 In B2B, statutory warranty is excluded or limited to the maximum extent permitted; where exclusion is not permitted, it is limited to 12 months from delivery.

9.2 At our option, the sole remedies are repair, replacement, or refund of the affected item(s).

9.3 Manufacturer guarantees (if any) are separate.

10. Liability

10.1 We are liable without limitation for intent, gross negligence, and personal injury under mandatory law.

10.2 Otherwise, liability is limited to typical foreseeable damages; no liability for indirect damages, loss of profit, loss of data/use, or production downtime, except where mandatory law requires.

10.3 Product liability: Statutory product-liability rules apply; note that Directive (EU) 2024/2853 will replace 85/374/EEC from 9 December 2026 (national implementations apply). eur-lex.europa.eu+1

11. Recalls, Safety Actions & Field Corrections

11.1 We may suspend supply, replace products, or issue corrective actions to comply with regulatory orders or safety notices.

11.2 You shall cooperate with FSCA/recall actions (including downstream notifications and logistics) and maintain records to enable traceability. eur-lex.europa.eu

12. Payment Default

12.1 If you fail to pay on time, statutory commercial default interest under §456 UGB (Austrian Commercial Code) applies (Austrian base rate + 9.2 percentage points) plus reasonable recovery costs. The base rate is published by the OeNB. oenb.at

12.2 We may withhold further deliveries or make them subject to prepayment or security.

13. Environmental Compliance (EPR, WEEE, Packaging)

13.1 Where EPR/packaging obligations apply in the destination Member State, you will register/report and finance required schemes (or reimburse us if law places obligations on us). Note the new EU Packaging & Packaging Waste Regulation (EU) 2025/40 replacing Directive 94/62/EC. eur-lex.europa.eu

13.2 For electrical/electronic devices, you will ensure compliance with WEEE Directive 2012/19/EU (producer registration, marking, take-back). eur-lex.europa.eu

14. Data Protection (GDPR)

14.1 We process personal data for contract performance, customer service, compliance, and security in accordance with GDPR (Reg. (EU) 2016/679) and our Privacy Policy. eur-lex.europa.eu

14.2 Where we process personal data on your behalf, a Data Processing Agreement will apply. You warrant you have a lawful basis to share any personal data with us.

15. Intellectual Property & Documentation

15.1 All IP in products, firmware/software, documentation, images, and website content remains with us or our licensors.

15.2 No licences are granted beyond what is necessary for intended use. You must not reverse engineer or remove identification/traceability markings.

16. Website Use & E-Commerce Notices

16.1 You agree to lawful, professional use of our website and not to misuse online services.

16.2 We fulfil applicable e-commerce information duties; see our Imprint and Privacy Policy. ris.bka.gv.at

17. Force Majeure

17.1 Neither party is liable for delays or failures caused by events outside reasonable control (e.g., epidemics, regulatory holds, export bans, transport disruptions, force majeure), provided the affected party notifies the other without undue delay.

18. Set-off & Assignment

18.1 You may set off only with undisputed or finally adjudicated claims.

18.2 Assignments require our prior written consent, except for monetary claims where mandatory law permits.

19. Confidentiality & Compliance

19.1 Business, technical, price, and customer information disclosed by either party is confidential and used only for contract performance.

19.2 You and we comply with applicable anti-bribery, sanctions, export control, and competition laws.

20. Governing Law, Venue & CISG

20.1 These Terms and any non-contractual obligations are governed by Austrian law, excluding conflict-of-laws rules.

20.2 Exclusive venue: competent commercial courts in Vienna (Handelsgericht Wien).

20.3 The CISG is excluded under Article 6 CISG. cisg-online.org

21. Changes to Terms

21.1 We may update these Terms for legal or operational reasons. The version in force on the order confirmation date applies. Material changes to ongoing framework agreements will be notified with reasonable advance effect.

22. Severability & Precedence

22.1 If any clause is invalid or unenforceable, the remainder remains effective; the invalid clause shall be replaced by a valid one closest to the original intent.

22.2 In case of conflict, a signed master agreement or written, order-specific terms prevail over these Terms.