General Terms and Conditions

1 Scope of Application

1. 1. These General Terms and Conditions apply to all offers from CTKMedical Christoph Taegert-Kilger Medical Device Development Consulting (“CONSULTANT”) concerning general consulting services. By accepting, the contractual partner (“CLIENT”) agrees to the validity of these General Terms and Conditions. These General Terms and Conditions apply regardless of whether the CLIENT is an entrepreneur (§14 BGB), a consumer (§13 BGB) or a legal entity under private or public law.
   2. Deviating conditions of the CLIENT shall not apply. This also applies if CTKMedical Christoph Taegert-Kilger Medical Device Development Consulting does not expressly object to their inclusion.
   3. Deviating conditions that extend, modify, or override conditions in these General Terms and Conditions can and must be specified either in the offer provided by the CONSULTANT, or in a framework or service contract signed by both parties.

2 Contract Conclusion, Scope of Delivery and Service

2. 1. The type and scope of services provided by the CONSULTANT are determined through the offer and the service modules specified therein. Additionally, these general terms and conditions become part of the contract.
   2. Offers by the CONSULTANT are non-binding. Parameters that may change until offer acceptance, such as costs, particularly estimated costs for subcontractors and services, are marked accordingly. Updated versions of an offer created based on agreement between the CONSULTANT and the CUSTOMER replace previous versions, which thereby become invalid.
   3. The placement of orders requires written or text form.
   4. Changes to the scope of services need to be mutually agreed between the parties.
   5. The CONSULTANT will represent the interests of the CLIENT to the best of their ability.
   6. The CONSULTANT is entitled to engage employees, expert third parties, and data processing companies for the execution of the contract. These parties are professionally or through appropriate contractual agreements with the CONSULTANT and/or the CLIENT obligated to maintain confidentiality.
   7. The CONSULTANT acts in relation to the CLIENT as an independent service provider within the definitions of §611 para. 1 BGB. §§611 ff. BGB also apply insofar as the services contain elements of other contract types. The dispositive provisions of the BGB are preceded by – in this order – individual agreements, individual orders, and these General Terms and Conditions. Dispositive provisions otherwise apply insofar as no conclusive regulations have been made in the aforementioned agreements and in these contractual conditions. When providing consulting and support services, the CONSULTANT does not owe success of the related activity. In particular, the CONSULTANT assumes no guarantee for the successful certification of companies or products.

3 Status of the CONSULTANT

3. 1. The CONSULTANT provides their services under the contract as a freelancer and is not considered an employee of the CLIENT. If and to the extent that the CONSULTANT employs their own employees for the provision of services, these employees are only considered employees of the CONSULTANT. The CONSULTANT acts in their own name and on their own account.
   2. The CONSULTANT bears and pays all taxes and social security contributions, if any, for themselves personally and all employees, if any. In the event that an employee or representative of the CONSULTANT raises claims against the CLIENT in relation to taxes and/or social security contributions, the CONSULTANT shall indemnify the CLIENT upon first request or reimburse the corresponding amounts.
   3. While providing services to the CLIENT, the CONSULTANT is not barred from accepting other orders nor from providing services to third parties, even if these are in direct or indirect competition with the CLIENT.

4 Obligations to Cooperate

4. 1. In the spirit of a trustful cooperation, the CLIENT will provide to the CONSULTANT all data necessary for provision of the contracted service; these data will be treated as confidential by the CONSULTANT.
   2. In particular, the CLIENT commits to,
      
      • provide all requested documents as early as possible;
      • assume tasks assigned to them according to the project plan and as agreed;
      • immediately review the work results of the CONSULTANT and provide feedback on any defects without delay;
      • inform the CONSULTANT of an expected delay if a deadline cannot be met;
      • designate a person authorized to make decisions, e.g., managing director, project manager, etc., as well as other contact persons where necessary, and inform about changes in these persons, and
      • respond to emails from the CONSULTANT within a reasonable time frame, usually no more than two working days.

5 Remuneration, Offsetting

5. 1. The remuneration for the services of the CONSULTANT is determined by the conditions specified in the offer.
   2. Travel and accommodation expenses will be reimbursed to the CONSULTANT to the following extent:
      
      • Travel costs: As a rule, travel costs are eligible for reimbursement as follows: For train journeys in 1st class; for trips with own car (mileage allowance 0.50 EUR per km); for taxi rides up to 50.00 EUR; and for flights in economy class within Germany at the most favorable rate.
      • Accommodation: Flat rate of 150.00 EUR per night;
      • Deviating from the accommodation costs listed under (b), it may be necessary to charge higher accommodation flat rates due to external influencing factors. In such a case, we will before the trip discuss and agree with the CUSTOMER.
      • Travel time: If remuneration is calculated according to an hourly rate, travel time is calculated at one-third of the actual travel time incurred.
   3. The CONSULTANT may demand a cancellation fee of up to 75% of the agreed remuneration in the event that they cannot provide the agreed services or cannot provide them at the planned time due to a violation of the CLIENT’s obligations to cooperate. Saved expenses are to be offset against this.
   4. The CONSULTANT will invoice the CLIENT for their services monthly, unless otherwise agreed.
   5. Invoices are to be paid within fourteen (14) days without deduction, unless a different agreement has been made. In the event of the CLIENT’s default of payment, the CONSULTANT is entitled to charge default interest in accordance with § 288 Para. 2 BGB. The CONSULTANT reserves the right to claim higher damages for default.
   6. The CLIENT may only offset claims for remuneration of the CONSULTANT with legally established or undisputed claims.

6 Liability

6. 1. The CONSULTANT is liable to the CLIENT in all cases of contractual and non-contractual liability for intent and gross negligence in accordance with statutory provisions for damages or compensation for futile expenses.
   2. In other cases, unless otherwise regulated in 6.3, the CONSULTANT is only liable for breach of a contractual obligation which is precondition for the proper execution of the contract and on which the CLIENT may regularly rely (so-called cardinal obligations), limited to compensation for foreseeable and typical damage. In all other cases, liability of the CONSULTANT is excluded, subject to the regulation in 6.3.
   3. Liability for damages resulting from injury to life, body, or health and under the Product Liability Act (Produkthaftungsgesetz) remains unaffected by the above limitations and exclusions of liability.
   4. The CONSULTANT assumes no responsibility or liability for information provided by third parties.
   5. In the internal relationship of the parties, the CLIENT shall indemnify the CONSULTANT from any liability arising from or in connection with the provision of services under the contract, unless this liability was caused by intent or gross negligence of the consultant.

7 Termination, Legal Consequences

7. 1. The CONSULTANT commences their consulting activity at the time agreed in the contract.
   2. The contract may be terminated without giving reasons with a notice period of one month to the end of a calendar month, unless otherwise agreed.
   3. Each party has the right to extraordinary termination for good cause.
   4. Good cause exists for the CONSULTANT in particular if the CLIENT is in arrears with the payment of the remuneration for a period of more than one month or repeatedly refuses their obligation to cooperate even after a warning has been issued.
   5. The termination requires written form.
   6. However, termination by one party does not affect the rights and obligations of the parties that arose before the legal effectiveness of the termination of the agreement.
   7. In the event of termination by the CLIENT, the agreed remuneration (proportionally) becomes due up to the date of effectiveness of the termination.

8 Confidentiality, Surrender of and Handling of Objects/Work Results

8. 1. Unless expressly agreed otherwise in individual cases or necessary for the fulfillment of their respective obligations towards the CLIENT or the CONSULTANT, the CONSULTANT and CLIENT commit to maintain confidentiality about the business and trade secrets and confidential information of the respective other contracting party that have become known to them and not to use them for their own purposes beyond the exploitation rights established by the contractual cooperation or to make them available to third parties. The obligation to maintain confidentiality also continues beyond the term of the contracts concluded between the parties. Both parties will ensure that this obligation is also observed by their employees.
   2. The CONSULTANT must carefully store all objects, in particular documents, tables, elaborations, hardware and software and copies, which they have obtained in the course of their contractual activity, as entrusted third-party property, protect them from any inspection or use by unauthorized persons, return them to the CLIENT at any time upon request and unsolicited upon termination of the contract, unless there is a legal obligation to retain them. Furthermore, a copy may remain with the CONSULTANT for documentation purposes. Sentences 1-3 apply accordingly to objects/work results created by the CONSULTANT for the CLIENT within the scope of the assignment.
   3. Publications or presentations by the CONSULTANT that relate to the provision of consulting services under this contract and/or the CLIENT’s business area require the prior consent of the CLIENT.

9 Data Protection

9. 1. The CLIENT ensures that the data processing systems, processes, and data stocks available to them comply with the EU General Data Protection Regulation (GDPR), the Federal Data Protection Act (Bundesdatenschutzgesetz, BDSG), and the respective State Data Protection Act (Landesdatenschutzgesetz). This applies in particular with regard to the processing within the meaning of Art. 4 No. 2 GDPR of data and data stocks. An appropriate data security system is also to be maintained by the CLIENT before and during the cooperation. The adequacy of the data security system is determined according to the legal requirements of Art. 32 GDPR.
   2. The CONSULTANT ensures that they do not take any actions in the fulfillment of the contract that violate existing data protection provisions. For this purpose, they commit in particular to the careful handling of passwords and other login data, which are disclosed to them for the fulfillment of the order. In individual cases, the CONSULTANT shall coordinate with the person responsible for data security (data protection officer) to be named by the CLIENT.
   3. The CONSULTANT obligates their vicarious agents who are employed by the CONSULTANT in a project for the CLIENT to also handle passwords and other login data carefully and to maintain data confidentiality in accordance with § 53 BDSG.
   4. The CONSULTANT and the CLIENT undertake to conclude a processing agreement in accordance with the requirements of Art. 28 GDPR, insofar as it is legally required for the execution of contracts concluded on the basis of these General Terms and Conditions. Processing is necessary in particular if the CONSULTANT is to process personal data for which the CLIENT has responsibility within the meaning of Art. 4 No. 7 GDPR in the context of contract performance.

10 Artificial Intelligence

10. 1. The CONSULTANT may use artificial intelligence (AI) in certain areas of their services to enable various functionalities and optimize their services. We will separately indicate the use of AI models for the relevant offerings. The AI models are trained on a variety of data and can recognize and respond to patterns to provide high-quality services.
    2. The CLIENT’s data is not used for training the CONSULTANT’s AI models. No personal data is transmitted to the AI models without the express consent of the CLIENT.
    3. Despite careful development and implementation, AI models can make mistakes. The CONSULTANT assumes no liability for decisions the CLIENT makes based on information provided by the AI. It is the CLIENT’s responsibility to evaluate the context and reliability of the information provided by the AI.

11 Intellectual Property

Content Provided by the CONSULTANT

11. 1. The content provided by the CONSULTANT may be protected by copyright. All rights thereby established, in particular the exploitation rights according to §§ 15 to 27 UrhG (Urheberrechtsgesetz), are reserved to the CONSULTANT or the authors and licensors, unless otherwise agreed.
    2. The CLIENT does not acquire any ownership or exploitation rights to the non-personalized content provided by the CONSULTANT, such as templates, etc., unless otherwise agreed.

Content Created Within the Scope of Contractual Obligations

11. 3. If and to the extent that intellectual property rights arise in relation to the work results through the services of the CONSULTANT, these rights are granted to the company for use and expectation. The payment of the agreed consulting fee is considered complete and final settlement of all intellectual property rights arising from and granted by this contract. This applies in particular to organizational or technical improvements that are not patentable in themselves.
    4. For inventions that the CONSULTANT makes within the scope of the service contract, the CLIENT has the right to register them for patent and to use them. The CONSULTANT is to be appropriately compensated. In case of doubt, the jurisdiction based on the Employee Invention Act (ArbEG) shall be consulted.

Content Provided by the CLIENT

1. 5. Intellectual property provided by the CLIENT will be treated by the CONSULTANT according to the rules in Section 8.

12 Adaptation of the General Terms and Conditions

12. 1. An adaptation of these framework conditions can occur,
       
       • if this is necessary due to applicable law
       • when expanding the CONSULTANT’s range of services
       • in case of a change in provisions that is advantageous for the CLIENT.
    2. The CONSULTANT shall inform the CLIENT about a change to these General Terms and Conditions before they become effective. The information about the change will be provided in an email message or in another appropriate form. At least 14 days before the changes take effect, there is the possibility to terminate the contracts concluded on the basis of these General Terms and Conditions. This does not affect the possibility to agree that the concluded contracts will continue under the conditions of the General Terms and Conditions effective at the time of conclusion, or to adapt them by mutual agreement following 2.4.

13 Final Provisions

13. 1. The partners will endeavor to reach an amicable settlement of any disputes that may arise. Otherwise, for legal disputes arising from or in connection with this contract, exclusively German law applies, excluding the provisions of international private law and excluding the UN Convention on Contracts for the International Sale of Goods.
    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 Darmstadt.
    3. No verbal side agreements exist. Supplementary or deviating agreements require written form to be effective. The written form requirement can only be waived by written agreement. Individual agreements within the meaning of §305b BGB are excluded from the formal requirements, insofar as formal requirements are not mandatory.
    4. Should any provision of this contract be or become invalid, contain an inadmissible time limitation or 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 instead of the invalid provision, which comes closest economically to what was intended by the parties. The same applies in the case of a gap. In the case of an inadmissible deadline, the legally permissible measure applies.
    5. A transfer of rights and obligations based on the contract by one party to third parties requires the prior written consent of the other party. Consent may only be refused for good cause.