Terms and Conditions

As of: April 2026

Andromedica Consulting – Dr. med. Torsten Binscheck-Domaß
Kopenhagener Straße 31c, 10437 Berlin, Germany
Email: contact@andromedica.de · Phone: +49 172 51 222 85

These Terms and Conditions are a convenience translation of the German “Allgemeine Geschäftsbedingungen”. In the event of any discrepancy, the German version shall prevail.

§ 1 Scope of Application

(1) These General Terms and Conditions (hereinafter “GTC”) apply to all consulting and service contracts between Andromedica Consulting – Dr. med. Torsten Binscheck-Domaß (hereinafter “Contractor”) and its clients (hereinafter “Client”).

(2) These GTC apply exclusively to entrepreneurs within the meaning of § 14 of the German Civil Code (BGB), legal entities under public law, and special funds under public law. Services are not provided to consumers within the meaning of § 13 BGB.

(3) Conflicting or deviating terms and conditions of the Client shall not become part of the contract unless the Contractor has expressly agreed to their validity in writing.

(4) These GTC shall also apply to all future services within the scope of the business relationship without the need for a renewed reference.

§ 2 Subject Matter of Services

(1) The Contractor provides scientific, regulatory, and clinical consulting services in the field of medical in-vitro diagnostic (IVD) system development. The range of services includes in particular:

• Scientific consulting (assay design, method validation, analytical performance evaluation, LC-MS/MS-based diagnostics, therapeutic drug monitoring)
• Regulatory support (EU IVDR, FDA, ISO 13485, ISO 15189, ISO 17025)
• Clinical affairs (planning of clinical performance studies, KOL management, medical affairs)
• Companion diagnostics (CDx) and biosimilar development
• Laboratory strategy and automation
• International market launch of IVD products

(2) The precise scope of services is defined by the respective consulting contract or the Contractor’s proposal. Changes to the scope of services require a written agreement.

(3) The Contractor owes professional consulting services, not a specific economic outcome. The consulting does not replace the Client’s own entrepreneurial decision-making responsibility.

(4) The Contractor is entitled to engage qualified third parties (subcontractors) for the provision of services, provided this has been coordinated with the Client.

§ 3 Conclusion of Contract and Proposals

(1) Proposals by the Contractor are non-binding unless expressly designated as binding.

(2) A contract is concluded by written order confirmation from the Contractor or by commencement of the provision of services. Transmission by email is deemed to satisfy the written form requirement.

(3) Oral side agreements shall have no validity. Amendments and supplements to the contract require text form.

§ 4 Remuneration and Fees

(1) Remuneration is based on the fee rates agreed upon in the proposal or contract. If no separate agreement has been made, the Contractor’s daily rates valid at the time of the order placement shall apply.

(2) All fees are net amounts plus the applicable statutory value-added tax, where applicable.

(3) Travel time is remunerated in accordance with the agreement made. Travel expenses (transportation, accommodation, additional meal expenses) are invoiced separately based on actual costs or in accordance with an agreed flat-rate approach.

(4) For longer-running projects (duration exceeding 3 months), the Contractor is entitled to issue monthly interim invoices corresponding to the share of services attributable to the respective month.

(5) The Contractor reserves the right to adjust fee rates with 4 weeks’ notice effective at the beginning of the next calendar month. For orders already placed and commenced, the agreed rate shall apply until completion of the respective order.

§ 5 Payment Terms

(1) Invoices are payable within 14 days of the invoice date without deduction, unless a different payment deadline has been agreed.

(2) In the event of late payment, the Contractor is entitled to charge default interest at a rate of 9 percentage points above the respective base interest rate (§ 247 BGB) and to claim a flat-rate dunning fee of EUR 40.00 (§ 288 (5) BGB).

(3) The Client is only entitled to set-off or to exercise a right of retention if its counterclaim is undisputed or has been legally established.

(4) In the event of justified doubts regarding the Client’s ability to pay, the Contractor may demand advance payment or security and suspend the further provision of services until such payment or security has been provided.

§ 6 Client’s Duty to Cooperate

(1) The Client is obliged to support the Contractor in the provision of services to a reasonable extent. In particular, the Client shall make available all information, documents, and data required for the consulting in a timely and complete manner.

(2) The Client shall designate a responsible contact person who is available for ongoing communication and decision-making.

(3) The Client shall ensure that the Contractor is granted access to the systems, premises, and information required for the provision of services.

(4) Delays or additional effort resulting from insufficient or late cooperation by the Client shall be borne by the Client. The Contractor is entitled to invoice the resulting additional effort separately.

(5) The Client is responsible for the accuracy and completeness of the information and documents provided. Damages arising from the inaccuracy of such information shall be borne by the Client.

§ 7 Confidentiality

(1) Both parties undertake to treat all confidential information of the other party obtained in the course of cooperation in strict confidence and not to disclose it to third parties, unless there is a statutory disclosure obligation.

(2) Confidential information includes in particular: trade and business secrets, technical and scientific data, regulatory strategies, product development plans, financial information, and all information that is marked as confidential or whose confidential nature is apparent from the circumstances.

(3) The obligation of confidentiality does not apply to information that (a) was already known to the recipient at the time of receipt, (b) is or becomes publicly available without this being due to a breach of duty by the recipient, (c) was communicated by a third party without a confidentiality obligation, or (d) was independently developed by the recipient.

(4) The confidentiality obligation shall remain in effect during the term of the contract and for a period of 5 years after termination of the contractual relationship.

(5) Upon request by the Client, all confidential documents provided shall be returned or demonstrably destroyed after termination of the contract.

(6) If a separate non-disclosure agreement (NDA) is concluded between the parties, it shall take precedence over the provisions of this section.

§ 8 Intellectual Property and Copyright

(1) All reports, expert opinions, concepts, strategy papers, and other work results (hereinafter “Work Results”) produced by the Contractor in the course of the contractual relationship are protected by copyright.

(2) Upon full payment of the agreed remuneration, the Contractor grants the Client a non-exclusive, non-transferable right of use of the Work Results for the contractually agreed purpose.

(3) Disclosure to third parties or use of the Work Results beyond the agreed purpose requires the prior written consent of the Contractor.

(4) Pre-existing intellectual property of the Contractor (in particular methods, frameworks, templates, and general expertise) remains exclusively with the Contractor. Such pre-existing knowledge is made available to the Client solely for use within the scope of the respective collaboration.

(5) The Contractor is entitled to cite the collaboration with the Client as a reference without disclosing confidential details, unless the Client expressly objects.

§ 9 Liability and Limitation of Liability

(1) The Contractor shall be liable without limitation for damages caused by intentional or grossly negligent conduct of the Contractor, its legal representatives, or vicarious agents.

(2) In cases of slight negligence, the Contractor shall only be liable for the breach of a material contractual obligation (cardinal obligation). In such cases, liability is limited to the foreseeable, contract-typical damage, but not exceeding twice the net amount of the remuneration agreed for the respective assignment.

(3) The above limitations of liability shall not apply to damages arising from injury to life, body, or health, or to claims under the German Product Liability Act.

(4) The Contractor shall not be liable for the accuracy, completeness, and currency of the information and documents provided by the Client, nor for damages resulting from the inaccuracy of such materials.

(5) The Contractor’s consulting services do not replace legal, tax, or other professional advice. The Client bears sole entrepreneurial responsibility for decisions made on the basis of the consulting results.

(6) The Client is obliged to mitigate damages to a reasonable extent (§ 254 BGB).

§ 10 Term and Termination

(1) The contract term is determined by the respective consulting contract or proposal.

(2) Project contracts may be terminated by either party without notice for good cause. Good cause exists in particular if a party violates material contractual obligations despite a written warning and fails to remedy such violation within a set deadline.

(3) Continuing obligations (framework agreements) may be terminated by either party with 4 weeks’ notice to the end of the month, unless a different notice period has been agreed.

(4) In the event of termination, the Client shall remunerate the services provided up to the date of termination at the agreed hourly rate or on a pro-rata basis. Costs already incurred shall be reimbursed in any case.

(5) Termination requires text form.

§ 11 Data Protection

(1) The Contractor processes personal data of the Client exclusively for the purpose of contract performance and in accordance with the General Data Protection Regulation (GDPR) and the German Federal Data Protection Act (BDSG).

(2) Insofar as the Contractor gains access to personal data of the Client or its employees in the course of providing services and processes such data, a separate data processing agreement pursuant to Art. 28 GDPR shall be concluded.

(3) Further information on data processing can be found in the privacy policy at www.andromedica.de/en/privacy.html.

§ 12 Compliance and Regulatory Notes

(1) The Contractor’s consulting services are based on the state of science, technology, and regulation applicable at the time of service provision. Regulatory requirements (in particular EU IVDR, FDA guidelines, ISO standards) are subject to continuous change; the Client is responsible for the ongoing monitoring and implementation of regulatory changes.

(2) The Contractor points out that its consulting services do not constitute legal or tax advice. For such matters, the Client is advised to consult qualified legal and tax advisors.

(3) Both parties undertake to comply with all applicable legal and regulatory requirements in the course of their business relationship, particularly with regard to anti-corruption, anti-money laundering, and export controls.

§ 13 Final Provisions

(1) Applicable law: The law of the Federal Republic of Germany shall apply to all legal relationships between the Contractor and the Client, excluding the UN Convention on Contracts for the International Sale of Goods (CISG).

(2) Jurisdiction: The exclusive place of jurisdiction for all disputes arising from and in connection with this contractual relationship is Berlin, provided the Client is a merchant, a legal entity under public law, or a special fund under public law.

(3) Severability clause: Should individual provisions of these GTC be or become wholly or partially invalid or unenforceable, the validity of the remaining provisions shall not be affected. In place of the invalid provision, such valid provision shall be deemed agreed that most closely approximates the economic purpose of the invalid provision.

(4) Written form / text form: Where these GTC require written or text form, transmission by email shall suffice. No oral side agreements exist.

(5) These GTC supersede all previous GTC of the Contractor.