General Terms and Conditions (GTC) – Radar Products 

1 Scope 

1. These General Terms and Conditions apply to the use of the Post-Market Manager offer, including all services provided under it (hereinafter “Post-Market Manager”) of Johner Institut GmbH, Reichenaustraße 39a, 78467 Konstanz, Germany (hereinafter “Johner Institut”). By placing an order, the contractual partner (hereinafter referred to as “customer”) agrees to the validity of these general terms and conditions. 

2. The contractual partner is the person or company that orders the product. 

3. Any deviating conditions of the customer shall not apply. This shall also apply if the Johner Institute does not expressly object to their inclusion. 

4. The version of the GTC valid at the time of the conclusion of the respective contract shall be decisive. 

2 Conclusion of contract 

1. The contract between the Johner Institute and the customer is concluded in writing when the customer accepts an offer from the Johner Institute. 

2. The contract shall be deemed concluded upon receipt by the Johner Institute of the customer's declaration of acceptance in the original, as a copy or in electronic form. Any offers of contract from the Johner Institute that have been modified by the customer shall be deemed to be a new offer from the customer, and the contract shall only be deemed concluded upon explicit acceptance by the Johner Institute; the provision of services shall not be deemed to be implied acceptance. 

 3 Access and duties of the customer 

1. Access to the contents of the Post-Market Manager is enabled by creating a customer account. 

2. Unless otherwise agreed, the access data is only valid for one user. 

3. The customer is obliged to keep the access data and passwords secret and to prevent unauthorized use by third parties. In the event of misuse, the Johner Institute is entitled to block access. The customer is liable for any misuse for which he is responsible. 

4. The customer is responsible for ensuring that he meets the technical requirements for accessing the content, in particular with regard to hardware and operating systems. In the event of further development of the offer by the provider, it is the customer's responsibility to independently take the necessary adaptation measures with regard to the software and hardware used by him. 

5. The customer is responsible for revoking access to the Post-Market Manager for users who leave the employment relationship with the customer. Should the Johner Institute become aware that a user is no longer actively employed by a customer, the Johner Institute may block access for that user. 

6. The user is always responsible for ensuring the regulatory compliance of a quality management system or technical documentation created with the help of the videos and templates from the Auditgarant or with the help of the Johner Academy. 

4 Scope of services and availability 

1. The content accessible to the customer as part of a membership is specified in the offer. 

2. The Post-Market Manager is generally available 24 hours a day, seven days a week, whereby an availability of 95% is provided over the calendar year. 

3. The Johner Institute is entitled to change, restrict or exchange the Post-Market Manager's content accessible via the respective membership, as well as to appropriately modify the content of modules, in particular to reduce or expand them. If such a change results in a significant restriction of the content accessible to the customer after membership, the customer is entitled to terminate the contract without notice. The right of termination can be exercised within a period of six weeks from the occurrence of the significant restriction. 

4. The Johner Institute does not guarantee regulatory compliance, the existence of audits or inspections of notified bodies, authorities or other regulatory instances of quality management systems or technical documentation. 

5 Intellectual property and rights of use; contractual penalty 

1. The content provided by the Johner Institute is protected by copyright. All rights arising therefrom, in particular those of reprinting, translating, reproducing by photomechanical or similar means, storing and processing by means of EDP or distributing in computer networks – including in the form of excerpts – are reserved by the Johner Institute or the authors. The customer does not receive any ownership or exploitation rights to the content provided. 

2. Within the scope of the ordered use and the following provisions, the customer receives the simple, non-transferable right to use the services listed and ordered in the offer, limited to the duration of the usage contract. 

3. The Johner Institute grants the customer the rights of use specified in the offer within the meaning of § 4 (1). 

4. The right of use is restricted to the customer. The documents retrieved may be used by the customer only for his or her own use during the period of use. Any passing on, in particular selling, renting, leasing or lending of content or documents is not permitted. 

5. It is not permitted to collect, duplicate, copy onto other data carriers or store on retrieval systems elements of the computer programs belonging to the content for use by unauthorized third parties. 

6. The Johner Institute is entitled to take technical measures to prevent use beyond the contractually permissible scope, in particular to install corresponding access blocks. 

7. The customer is not entitled to use devices, programs or other means that serve to circumvent or overcome the technical measures of the provider. In the event of a violation by the customer, the provider is entitled to immediately block access to the content and to terminate the contract without notice. Further rights and claims of the provider, in particular claims for damages, remain unaffected. 

8. The customer is obliged to comply with the applicable laws and regulations when using the Johner Institute's offers. In particular, no content, materials or information may be published or otherwise made available that violates legal provisions and/or these terms of use. In particular, the reproduction, publication and distribution of Johner Institute content (videos, downloads, other materials provided), in any form, is prohibited, unless expressly agreed otherwise. 

9. The Johner Institute is not responsible for content (e.g. texts, images, layouts, illustrations) that the customer provides or uploads or for content that results from use by third parties, in particular contractual partners of the customer. 

10. The customer may not misuse the services offered by Johner Institut, regardless of the manner in which they are used. Misuse shall be deemed to have occurred in particular in cases where the customer uses the services in a way that would require the granting, transfer or exercise of rights under the Copyright Act. 

11. Any culpable infringement of § 5 (10) shall result in a contractual penalty. In such cases, the user shall pay a sum of €2,500 for each individual infringement and for each repeat infringement. Further claims shall remain unaffected. 

6 Contract duration and termination 

1. Unless otherwise agreed, this contract has a minimum term of one year and a notice period of three (3) months. Termination notices can be sent in writing to the institute's address given above or by email to dpms-circle@johner-institut.de. If a notice of termination is not given in due time, the contract will be extended by a further year in each case. 

2. The right to terminate for good cause remains unaffected. 

7 Remuneration 

1. The remuneration to be paid by the Customer for the use of the Post-Market Manager is specified in the Offer concluded with the Johner Institute. 

2. The remuneration for the use of the Post-Market Manager is to be paid in advance in each case. The exact terms of payment are described in the Offer. 

8 Liability 

1. The Johner Institute shall be liable to the Customer in all cases of contractual and non-contractual liability in the event of intent and gross negligence in accordance with the statutory provisions for damages or reimbursement of wasted expenses. 

2. Liability for defects of any kind in content generated using the Post-Market Manager (e.g. PDF exports) is excluded, unless the defects are due to a fault in the Post-Market Manager itself. The customer shall indemnify the Johner Institute and its agents against liability for defective content in relation to third parties. 

3. In other cases, the Johner Institute shall be liable, unless otherwise provided for in paragraph 4, only in the event of a breach of a contractual obligation, the fulfillment of which is essential for the proper execution of the contract and on the observance of which the customer may regularly rely (so-called cardinal obligation), and this shall be limited to compensation for foreseeable and typical damage. In all other cases, the Johner Institute shall not be liable, subject to the provision in paragraph 4. 

4. The liability for damages arising from injury to life, limb or health and under the Product Liability Act remains unaffected by the above limitations and exclusions of liability. 

9 Artificial Intelligence (AI) Services 

1. The Johner Institute uses artificial intelligence (AI) (models from Azure OpenAI) in certain areas of the Post-Market Manager to enable functionalities such as analysis of customer-specific databases and generation of targeted responses. 

2. The AI models are trained on a large amount of data and can recognize patterns and respond to them to provide high-quality services and support customers in analyzing databases they have built themselves. 

3. The customer's data will not be used to train the AI models. No personal data is transferred to the AI models. Even if personal data is stored in the Post-Market Manager, it will not be passed on to third parties when using the AI models. 

4. Despite careful development and implementation, AI models can make mistakes. Johner Institute does not accept any liability for decisions that customers make based on the information provided by the AI. It is the customer's responsibility to evaluate the context and reliability of the information provided by the AI. 

5. By using the Post-Market Manager, the customer accepts that Johner Institute uses AI models in the Post-Market Manager and agrees to the associated conditions. 

10 Final Clauses 

1. For legal disputes arising from or in connection with this contract, German law applies exclusively, excluding the provisions of international private law and excluding the UN Sales Convention. 

2. For merchants or persons without permanent residence in Germany, the exclusive place of jurisdiction for legal disputes arising from or in connection with this contract is Konstanz. 

3. Any additional or deviating agreements must be made in writing to be effective. The written form requirement can only be waived by a written agreement. 

4. Should any provision of this contract be or become invalid, contain an impermissible time limit or contain a gap, the legal validity of the remaining provisions shall remain unaffected. Insofar as the invalidity does not result from a violation of §§ 305 ff. BGB, a valid provision shall be deemed agreed in place of the invalid provision which most closely approximates the economic intent of the parties. The same shall apply in the event of an omission. 4.In the event of an inadmissible time limit, the legally permissible measure shall apply.