General Terms and Conditions of SIFo GmbH (SIFo)

§ 1 Scope

1.1 These General Terms and Conditions (GTC) apply to all transactions between SIFo and its customers regarding the provision of digital content. Any GTC of the customer that deviate from these GTC or from changes and additions confirmed in writing by SIFo are hereby expressly excluded. Deviations from these GTC can only be agreed upon in written form.

1.2 SIFo's offer to provide digital content is exclusively directed at entrepreneurs (B2B). SIFo does not enter into contracts with consumers (B2C). When concluding the contract, the customer must confirm that they are an entrepreneur and provide their valid VAT identification number as proof.

1.3 These GTC also apply to all future contracts with the customer regarding the provision of digital content until SIFo issues new GTC, even if these are concluded without reference to these GTC. The version valid at the time of contract conclusion is applicable.

§ 2 Contract Conclusion

2.1 SIFo offers its customers digital content on the website www.sifo-medical.com ("Website"), particularly on the subject of test method validation in medical technology. A detailed description of the digital content and its prices are displayed directly on the website.

2.2 A binding contract for the paid provision of digital content is concluded on the website www.sifo-medical.com by clicking the "Order Now" button. After prepayment (§ 3.2), the customer receives online access to the digital content and must create their own user account through which they access the digital content. The customer may only use the access to the digital content personally for their own business purposes. The digital content is provided to the customer for an indefinite period. The customer agrees not to reproduce, modify, or make available the digital content to third parties (including affiliated companies).

2.3 The customer is responsible for ensuring that they have the necessary hardware, software, and sufficient internet connection to access the digital content through their user account and must choose a secure password for their user account.

2.4 Without prior written consent from SIFo, the customer is not entitled to transfer rights and obligations from the contractual relationship with SIFo to a third party.

2.6 Unless expressly and in writing otherwise agreed, SIFo does not grant the customer a contractual right of withdrawal from the contract conclusion.

§ 3 Payment and Compensation

3.1 The amount of compensation for the provision of digital content is indicated at the time of ordering and, in case of doubt, is exclusive of VAT. By concluding the contract, the customer confirms their knowledge and appropriateness of the compensation.

3.2 Payment of the compensation must be made in advance and is a prerequisite for the provision of digital content. The possible payment methods are indicated directly on the website.

3.3 After payment has been made, SIFo will issue the customer a proper invoice for the compensation.

3.4 SIFo is entitled to send invoices to the customer in electronic form. The customer expressly agrees to receive invoices in electronic form.

§ 4 Copyright and Right of Use

4.1 All provided digital content by SIFo are copyrighted works. The exclusive right of use for these works is held by SIFo.

4.2 Unless expressly agreed otherwise, SIFo grants its customers only simple rights of use and not exclusive rights of use. The granting of a right of use in favor of the customer is limited to the personal use of the content within their own company. A right of use in favor of the customer is only granted after full payment of the agreed compensation.

§ 5 Warranty and Compensation

5.1 SIFo warrants that the digital content will be available for retrieval through the customer's user account and that it corresponds to the agreed performance description. The digital content is created to the best of knowledge and belief and the current state of technology in the relevant subject area.

5.2 SIFo cannot provide warranty or liability for circumstances beyond their control. This includes, in particular, cases of force majeure, natural disasters, power or internet outages.

5.3 A complaint must include a specific, most detailed possible description of the defects (e.g., an error message when retrieving digital content). Adequate documentation of the defects must be made within four weeks of their occurrence. If the complaint is justified and timely, the customer initially only has the right to improvement of the performance. Claims for a reduction in payment or cancellation are only granted if SIFo's attempts to rectify the defect fail even after one month.

5.4 Claims for damages in cases of slight negligence are mutually excluded; this does not apply to personal injury. The customer must prove that a damage is attributable to a fault of SIFo. Claims for damages by the customer can only be asserted in court within six months of knowledge of the damage and the injuring party, but at the latest within three years after the event giving rise to the claim. Consequential damages and lost profits, especially in the case of delayed or defective performance, are excluded from liability. SIFo is not liable for damages that the customer suffers due to disregard of the content explanations of the digital content. As far as SIFo's liability is excluded or limited, this also applies to the personal liability of SIFo's employees, representatives, and agents.

§ 6 Data Protection

6.1 In the context of contract conclusion, SIFo stores and processes the customer's first and last name or company name, VAT identification number, salutation, address (postal address, email address, phone number), contact persons at the customer, ordered digital content, compensation and payment status, as well as any correspondence with the customer (collectively: "personal data"). These personal data are processed – unless there is an express further consent from the customer – solely for the purpose of contractual processing and provision of the digital content. These data are lawfully collected according to Art. 6(1)(b) GDPR, as they are necessary for the fulfillment of the contract between SIFo and the customer. Without providing these personal data, continuous provision of the digital content cannot take place. The collected data will be deleted when the customer deletes their user account, and no other legal reason for further use exists (especially explicit consent from the customer, statutory retention periods, or open warranty or compensation periods). The specific contract is stored for the purpose of contract fulfillment and proof of contract conclusion.

6.2  Personal data of the customer are only shared as far as necessary for fulfilling this contract, particularly with the following recipients:

• Stripe: SIFo uses the payment service provider Stripe (provided in Europe by: Stripe Payments Europe, Limited (SPEL), 1 Grand Canal Street Lower, Grand Canal Dock, Dublin, D02 H210, Ireland) for payment processing. The following data may be transmitted to Stripe:
  • Name
  • Email address
  • Contact number
  • Billing and shipping address
  • Payment method information (e.g., credit or debit card number, bank account, or the customer's chosen payment card image)
  • Information about the merchant and the location
  • Purchase amount and date
  • Information about the purchased item Further information on Stripe's data protection is provided under the following link: https://stripe.com/privacy
• Odoo: SIFo uses the services of Odoo (Odoo SA, Rue du Laid Burniat 5, 1348 Louvain-la-Neuve, Belgium) for providing quotations and invoices. Odoo collects and processes the data listed in § 6.1 on behalf of SIFo to provide the services subscribed by SIFo. Odoo's customer service representatives and engineers can access this information in a limited and appropriate manner to resolve any issues with order processing. Further information on Odoo's data protection is provided under the following link: https://www.odoo.com/privacy

6.3 If the customer is a natural person, they have the right at any time to request information about the data SIFo has collected about them. If the collected data are incorrect or become incorrect, the customer can request correction of the data. If the legal requirements are met, the customer also has the right to deletion (Art. 17 GDPR), restriction of processing (Art. 18f GDPR), and data portability (Art. 20 GDPR). A German version of the GDPR is available at https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679&from=DE

6.4 For questions regarding the processing of their data, customers can contact SIFo at the following address: office@sifo-medical.com

6.5 If the customer is a natural person and believes that SIFo is violating legal provisions while processing their personal data, they have the right to file a complaint with the Austrian Data Protection Authority, Barichstraße 40-42, A-1030 Vienna, or with the national supervisory authority of their residence.

§ 7 Final Provisions

7.1 All agreements that include changes, additions, or specifications of these GTC, as well as special assurances and arrangements, must be made in writing. This also applies to the agreement to deviate from this requirement of written form. If they are declared by SIFo's employees, they are only binding if authorized representatives of SIFo give their written consent. All notifications and declarations of the customer concerning this contractual relationship must be made in writing.

7.2 The contract language is German. The German version of these GTC is the authoritative version.

7.3 The contractual relationship between SIFo and the customer is governed by the law of the Republic of Austria, excluding the UN Convention on Contracts for the International Sale of Goods (CISG) and the conflict of laws rules of international private law and Rome I.

7.4 For all disputes, the exclusively competent court in Innsbruck, Austria, is responsible. However, SIFo reserves the right to sue the customer at their place of business.

7.5 If individual provisions of these GTC are or become wholly or partially invalid, the validity of the remaining provisions remains unaffected. In this case, the invalid provision is to be replaced by a legally effective regulation that comes closest to the economic purpose of the invalid provision or the presumed intent of the contracting parties. The same applies if a provision proves to be impracticable for practical reasons.

SIFo GmbH
Baerenweg 11
6140 Telfs
Austria

Tel: +43 512 411027
E-Mail: office@sifo-medical.com
Web: https://www.sifo-medical.com/

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§ 1 Scope of Application

1.1 These General Terms and Conditions (hereinafter: “GTC”) apply to digital analysis services for medical devices provided by SIFo. Any general terms and conditions of the customer that deviate from these GTC or from amendments or supplements confirmed in writing by SIFo are hereby expressly excluded. Deviations from these GTC may only be agreed upon in writing.

1.2 SIFo’s offer is directed exclusively at other entrepreneurs (B2B). Orders from consumers (B2C) are not accepted. The customer shall confirm during the ordering process that it is acting as an entrepreneur.

1.3 These GTC shall also apply to all future contracts with the customer until new GTC are issued by SIFo, even if such contracts are concluded without express reference to these GTC. The version in force at the time of conclusion of the contract shall be determinative in each case.

§ 2 Conclusion of Contract

2.1 SIFo offers its customers the opportunity in its web shop at www.sifo-medical.com to purchase credits for the use of analysis services for medical devices pursuant to § 3.

2.2 The customer may purchase credits for analysis services in SIFo’s web shop by selecting the desired credits and clicking the button “Buy”. Upon receipt of payment, the purchased credits shall be credited to the customer’s user account and may be used for analysis services at any time.

2.3 The credits are valid for a period of three (3) years from the date of purchase and are non-refundable. An extension of the validity period is only possible with the express consent of SIFo.

2.3 Without the prior written consent of SIFo, the customer is not entitled to transfer credits to third parties.

§ 3 Provision of Analysis Services

3.1 The analysis services offered by SIFo enable a supported risk analysis for medical devices. A detailed description of the analysis services and the applicable prices can be found directly in SIFo’s web shop at www.sifo-medical.com. SIFo’s analysis services are performed by means of an AI analysis tool developed by SIFo (SIFo AIRA).

3.2 The customer may access SIFo’s analysis services at any time in the internal user area of SIFo’s web shop by using credits. The analysis services are provided exclusively online via SIFo’s web shop. To use the services, the customer must have a valid user account and sufficient credits.

3.2 In order for the analysis services to be successfully performed, the customer must upload the required data or respond to the prescribed questionnaire. The customer is solely responsible for the completeness and accuracy of the data and responses submitted to SIFo for analysis. Once an analysis has been commissioned, no further changes to the data or responses may be made. To supplement or amend data or responses, a new analysis must be initiated. SIFo is not required to carry out any plausibility check of the data or responses provided. The customer acknowledges that the risk analysis may yield both positive and negative results.

3.3 The customer undertakes to provide SIFo with data for analysis only that does not constitute personal data within the meaning of Art. 4(1) of the General Data Protection Regulation (GDPR). If the customer wishes to have personal data analysed, such data must be properly anonymised by the customer on its own responsibility prior to submission to SIFo.

3.4 SIFo is entitled to modify the scope, content, or structure of the analyses at any time, insofar as this serves to improve the offering or is required for regulatory reasons.

§ 4 Prices and Payment

4.1 The prices for credits for analysis services are set out in SIFo’s web shop. All prices shall, in case of doubt, be understood as exclusive of value added tax.

4.2 Payment for credits shall be made in advance and constitutes a prerequisite for the use of analysis services. The available payment methods are indicated directly in SIFo’s web shop.

4.3 SIFo shall issue the customer with a proper invoice.

4.4 SIFo is entitled to transmit invoices to the customer in electronic form. The customer expressly consents to the receipt of invoices in electronic form.

§ 5 Warranty

5.1 SIFo warrants that the analysis services, at the time of use by the customer, comply with the standard ISO 14971:2019 and are free of defects. The analysis services are suitable for the described use.

5.2 Warranty claims shall become statute-barred six months from the date of use of an analysis. Warranty claims may only be asserted by the respective customer itself.

5.3 In the event of a defect in the analysis, SIFo shall be entitled to remedy the defect by way of subsequent performance through a new analysis (replacement delivery). The customer shall grant SIFo the necessary time and opportunity to carry out subsequent performance; failing this, SIFo shall be released from its warranty obligations. The customer shall cooperate in the subsequent performance to the extent necessary.

5.4 No warranty claim shall exist in respect of minor defects.

5.5 The customer shall be entitled to rescind the contract only if the defect is not minor and subsequent performance by SIFo fails, is in particular impossible, or if SIFo does not manage to remedy the defect within a reasonable period of at least two weeks, refuses to do so, or culpably delays remedying the defect.

5.6 SIFo does not warrant compliance with any special regulations applicable in the country of destination.

§ 6 Liability and Damages

6.1 SIFo shall be liable for analysis services only in cases of intentional or negligent causation of damage. Claims for damages in cases of minor negligence are mutually excluded; this exclusion shall not apply to personal injury. The customer bears the burden of proving gross negligence or wilful misconduct in the causation of damage. Liability shall be limited to typical and foreseeable contractual damage. Liability for loss of profit, indirect damages, delays, or data loss is excluded.

6.2 The customer bears the burden of proving in each case that the damage is attributable to fault on the part of SIFo.

6.3 Claims for damages by the customer may only be brought before a court within six months of the customer becoming aware of the damage and the party responsible, but in any event no later than three years after the performance of the analysis service.

6.4 SIFo assumes no liability for misinterpretations by the customer of the analysis results or for any measures taken by the customer on the basis thereof. Interpretation and conclusions are at the customer’s sole risk.

§ 7 Intellectual Property

All content, analyses, and tools of SIFo are protected by copyright. The customer receives a simple, non-transferable licence to use the analysis results. SIFo is entitled to use the analyses itself for internal evaluation and statistical purposes.

§ 8 Data Protection

8.1 In the context of concluding the contract, SIFo stores and processes the customer’s first and last name or company name, value added tax identification number, salutation, address (postal address, e-mail address, telephone number), contact persons at the customer’s premises, purchased credits, payment status, the data and responses uploaded by the customer, and the analysis services performed (collectively hereinafter: “personal data”). Such personal data shall – unless the customer has provided express consent beyond this – be processed solely for the purpose of contractual performance and the provision of the analysis services. These data are collected lawfully pursuant to Art. 6(1)(b) of the General Data Protection Regulation (hereinafter: “GDPR”), as they are necessary for the performance of the contract between SIFo and the customer. Without the provision of such personal data, the performance of the analysis services cannot therefore take place. Following completion of the analysis services and expiry of the warranty period (six months pursuant to § 5) and the absolute limitation period for damages claims (three years after performance of the analysis service pursuant to § 6), the collected data shall be deleted, unless any other legal basis for continued use exists (in particular, express consent of the customer or statutory retention periods). Disclosure of personal data of the customer shall occur only to the extent strictly necessary for the performance of this contract. The specific contract shall be stored for the purpose of performing the delivery and as evidence of the conclusion of the contract.

8.2 The customer, if a natural person, has the right to request information from SIFo regarding which data SIFo has collected about it. If the collected data is or becomes incorrect, the customer may request rectification of the data. Where the legal requirements are met, the customer also has the right to erasure (Art. 17 GDPR), the right to restriction of processing (Arts. 18 et seq. GDPR), and the right to data portability (Art. 20 GDPR). An English version of the GDPR is available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679

8.3 Customers may contact SIFo at the following address for any questions regarding the processing of their data: office@sifo-medical.com

8.4 If the customer is a natural person and believes that SIFo is processing its personal data in breach of applicable law, the customer is free to lodge a complaint with the Austrian Data Protection Authority (Datenschutzbehörde), Barichgasse 40–42, A-1030 Vienna, or with the national supervisory authority of the customer’s country of residence.

§ 9 Final Provisions

9.1 All agreements containing amendments, supplements, or specifications to these GTC, as well as any special representations and commitments, must be made in writing. This shall also apply to any agreement to waive this formal requirement. If made by employees of SIFo, such agreements shall be binding only if the authorised governing bodies of SIFo have given their written consent. All notices and declarations by the customer relating to this contractual relationship must be made in writing.

9.2 The language of the contract is German. The German version of these GTC shall be the authoritative version.

9.3 The contractual relationship between SIFo and the customer shall be governed by the laws of the Republic of Austria, to the exclusion of the United Nations Convention on Contracts for the International Sale of Goods (CISG / Vienna Convention), and to the exclusion of the conflict of law rules of private international law and the Rome I Regulation.

9.4 The exclusive place of jurisdiction for all disputes shall be the court of competent subject-matter jurisdiction in Innsbruck, Austria. SIFo reserves the right, however, to bring proceedings against the customer before the courts of the customer’s registered office.

9.5 Should any individual provision of these GTC be or become wholly or partially invalid or unenforceable, the validity of the remaining provisions shall not be affected. In such case, the invalid provision shall be replaced by a legally valid provision that corresponds to, or most closely approximates, the economic purpose of the invalid provision or the presumed intention of the contracting parties. The same shall apply if any provision proves to be unenforceable for practical reasons.

SIFo GmbH
Baerenweg 11
6140 Telfs
Austria

Tel: +43 512 411027
E-Mail: office@sifo-medical.com
Web: https://www.sifo-medical.com/

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