Entities: Pyoor Smile LTD (Israel) | ARC Ortho Dental S.L. (Spain)

1. Scope and General Provisions

1.1 These General Terms and Conditions (“T&C”) govern all legal transactions, offers, and services provided through the digital portal (the “Portal”) operated by Pyoor Smile LTD (Israel) and ARC Ortho Dental S.L. (Spain) (collectively referred to as the “Company”) . 1.2 The Company acts as a distributor and importer for Ensmile (the “Manufacturer”), which is exclusively responsible for the clinical design of treatment plans, manufacturing, and compliance with quality standards (ISO 13485). 1.3 These T&C apply to all professional contracts with licensed dental practitioners (“Doctor” or "Principal") and shall apply to all future business relations.

 

2. Services and Clinical Responsibility

2.1 The Portal provides technical and planning support for custom-made orthodontic devices. 2.2 Medical Decision Maker: The Doctor is the sole party responsible for patient diagnosis, case selection, and the final decision to approve and implement the treatment plan. 2.3 The Company and Manufacturer provide technical suggestions only; the final clinical responsibility remains at all times with the Doctor.

 

3. Orders and 3-Hour Cancellation Policy

3.1 Every order constitutes a request for a Custom-made Device tailored to a specific patient. 3.2 Cancellation Window: Due to the personalized nature of the devices, an order may be modified or cancelled only within three (3) hours of the Doctor’s final clinical approval in the Portal. 3.3 After the 3-hour window has elapsed, the production process begins automatically, and the Doctor shall be liable for the full payment of the order.

 

4. Intellectual Property and Prohibition of Reverse Engineering (Expanded)

4.1 Ownership: All intellectual property rights, including but not limited to software code, proprietary algorithms, 3D simulation workflows, product designs, and treatment planning protocols (“Company IP”), are the sole property of the Company or its licensors. 4.2 Reverse Engineering: The Doctor is strictly prohibited from, and shall not permit any third party to:

 

• Reverse-engineer, decompile, disassemble, or otherwise attempt to derive the source code or underlying structure of the Portal or its planning algorithms.
   

• Copy, reproduce, or create derivative works from the Company IP without explicit written authorization. 4.3 Remedies: Any unauthorized use or attempt to reverse-engineer the technology constitutes a material breach, entitling the Company to immediate injunctive relief and monetary damages.
   

5. Force Majeure (Expanded)

5.1 The Company shall not be liable for any delay or failure in performance resulting from events beyond its reasonable control, including but not limited to: pandemics, epidemics, industrial strikes, wars, riots, government interventions, or severe global logistics disruptions . 5.2 If a force majeure event persists for more than ninety (90) days, either party may terminate the affected contract without further liability, though payments for services rendered prior to the event remain due.

 

6. Pricing and Payment Terms

6.1 Prices are governed by the Company’s official price list or specific estimates confirmed via the Portal. 6.2 Invoices are due within 14 days of the invoice date. 6.3 The Doctor provides a personal guarantee for all payments arising from orders placed under their Portal credentials.

 

7. Warranty and Liability

7.1 The Doctor must inspect all goods immediately upon receipt and report any defects within five (5) working days. 7.2 Manufacturing vs. Clinical: Liability for manufacturing defects lies with the Manufacturer. The Company is not liable for clinical outcomes or failures arising from inaccurate documentation provided by the Doctor . 7.3 To the maximum extent permitted by law, the Company’s liability is limited to foreseeable damages typical for this contract .

 

8. Data Protection and International Transfers

8.1 All processing of medical data complies with the GDPR (EU) and the Israeli Privacy Protection Law . 8.2 Identification is conducted via a Unique Case ID to ensure patient names are not printed on packaging . 8.3 Data may be transferred to the Manufacturer’s facilities in Portugal and processing centers in Pakistan, subject to strict security and confidentiality protocols .

 

9. Arbitration and Jurisdiction (Expanded)

9.1 Mediation: Any disputes shall first be subject to good-faith mediation between the parties. 9.2 Arbitration (International/EU): For disputes involving ARC Ortho Dental S.L., if mediation fails, the matter shall be resolved through binding arbitration under the rules of the German Arbitration Institute (DIS) or the relevant Spanish commercial arbitration board, with the venue in Madrid or Barcelona . 9.3 Jurisdiction (Israel): For disputes involving Pyoor Smile LTD, the laws of the State of Israel shall apply, and the exclusive venue shall be the competent courts of Tel Aviv.

 

10. Indemnification

10.1 The Doctor agrees to indemnify and hold the Company harmless from any third-party claims arising from the Doctor’s clinical use of the products in violation of these terms or professional standards.