1. GENERAL PROVISIONS

1.1. These Purchase Conditions ("PC") are intended for use exclusively in business-to-business transactions with entrepreneurs. They apply to every – including future – contractual agreement (e.g. in the form of individual orders or call-offs; hereinafter referred to as "Order") regarding the manufacture, processing and delivery of raw materials, semi-finished or finished products, tools, machines and systems, as well as for the provision of (work or service) performances ("Contract Products") by the Supplier ("Supplier") for LAUDA Medical GmbH & Co. KG or for an affiliated company within the meaning of Section 15 of the German Stock Corporation Act (AktG) ("LAUDA MEDICAL") that agrees on or calls off Orders with the Supplier.

1.2. LAUDA MEDICAL places orders on the basis of these PC. Conflicting, deviating or additional General Terms and Conditions of the Supplier or third parties shall not become part of the contract between LAUDA MEDICAL and the Supplier (collectively: "Parties"); this also applies if LAUDA MEDICAL does not expressly object to their validity in individual cases or if the Supplier or third parties refer to their conditions in the course of correspondence (particularly in connection with the conclusion of a contract) (for example in letters, emails or for technical system reasons). General Terms and Conditions of the Supplier or third parties shall only become part of the contractual relationship between the Parties if this is expressly agreed in writing between the Parties.

1.3. In an ongoing business relationship, the PC shall also apply if LAUDA MEDICAL does not provide the PC again for follow-up orders.

2. CONTRACT FORMATION, ORDER, CHANGES

2.1. Unless expressly agreed otherwise in writing, a contract is concluded when the Supplier accepts an offer or an Order from LAUDA MEDICAL. Acceptance of an offer or an Order by the Supplier shall be effected (1) by confirmation in text form or (2) by the Supplier commencing execution of the services specified in the offer or the Order or (3) the Supplier does not object to the offer or the Order in text form within three working days of receipt of the offer or the Order.

2.2. The costs incurred by the Supplier in connection with the initiation of a contract, particularly in connection with visits and the preparation of cost estimates, offers and project studies, shall not be reimbursed by LAUDA MEDICAL unless there is an express written agreement between the Parties to that effect.

2.3. Orders as well as their amendments and supplements must be made by email or in written form.

2.4. LAUDA MEDICAL may request changes to the ordered quantities and other delivery conditions if these are not unreasonable for the Supplier. This applies in particular until acceptance of an Order by the Supplier (cf. Section 2.1.). Additional or reduced costs shall be charged accordingly.

2.5. LAUDA MEDICAL is entitled at any time to request changes to the Contract Products in design and execution ("Change Request"). The Supplier must evaluate the Change Request and its effects without delay, particularly with regard to technical properties, mandatory legal provisions, additional and reduced costs as well as implementation possibilities and delivery dates, and submit the result of the evaluation of the Change Request to LAUDA MEDICAL in writing without delay. After the expiry of two weeks from receipt of the Change Request without notification, the previously agreed price shall continue to apply, unless the Supplier immediately informs LAUDA MEDICAL with reasons why such notification cannot be made within two weeks. Before the Supplier implements a change, express written approval by LAUDA MEDICAL is required.

2.6. All changes intended by the Supplier must be reported immediately in writing and also require prior written approval by LAUDA MEDICAL before implementation.

2.7. With regard to change management, the provisions of Section 3 PC apply in addition to this Section 2.

3. INFORMATION AND CHANGE MANAGEMENT

3.1. The Supplier shall provide LAUDA MEDICAL with all information that makes it possible to understand the design phases that the product has undergone.

3.2. The Supplier shall provide LAUDA MEDICAL with all manufacturing information that makes it possible to understand the manufacturing processes such as production, assembly, final product testing and packaging of the finished product.

3.3. Notwithstanding more specific provisions in individual cases, the Supplier shall inform LAUDA MEDICAL without delay that agreements made, such as quality characteristics, dates, delivery quantities, cannot be met.

3.4. The Supplier shall also inform LAUDA MEDICAL without delay of all deviations identified after delivery. In the interest of a quick solution, the Supplier shall disclose all necessary data and facts.

3.5. The Supplier undertakes in particular and in addition to Section 2.5 of these PC to notify LAUDA MEDICAL in sufficient time before:

• Changes to manufacturing processes, procedures and materials (also with sub-suppliers),

• Change of sub-supplier,

• Changes to testing procedures/facilities,

• Relocation of production sites,

• Relocation of production facilities at the site, and

• Outsourcing of work steps

so that LAUDA MEDICAL can examine whether the planned changes may have adverse effects.

3.6. The Supplier shall document all changes to the product and process chain including any verifications and submit them to LAUDA MEDICAL upon request.

3.7. Changes may only be implemented by the Supplier after written approval from LAUDA MEDICAL.

4. PRICES, PAYMENT TERMS, INVOICING

4.1. The prices are fixed prices delivered to our plant plus statutory value-added tax (if applicable). The agreed price is the entire remuneration to be paid by LAUDA MEDICAL, with which all work, services and expenses of the Supplier with the relevant Order are completely settled; it also includes all ancillary costs, in particular the costs of freight, customs, packaging (including return and disposal of packaging by the Supplier), expenses and value-added tax.

4.2. Invoices must be sent in single copy stating invoice number, order number, quantity, price and other allocation features, in particular LAUDA MEDICAL article number, by email to invoice@lauda-medical.com and can be paid by LAUDA MEDICAL within 14 days of receipt of invoice and Contract Product with 2 percent discount or within 30 days without deduction. E-invoices must be sent in single copy in ZUGFeRD format stating invoice number, order number, quantity, price and other allocation features, in particular LAUDA MEDICAL article number, by email to e-invoice@lauda-medical.com and can be paid by LAUDA MEDICAL within 14 days of receipt of invoice and Contract Product with 2 percent discount or within 30 days without deduction. The commencement of the period is determined cumulatively by the defect-free delivery of the Contract Products and the receipt of a proper and auditable invoice. Payment by LAUDA MEDICAL is deemed to be on time if the transfer order is received by the bank commissioned by LAUDA MEDICAL before the expiry of the payment period. Incorrect or incomplete invoices are deemed not to have been received until they have been corrected or supplemented accordingly.

5. PLACE OF PERFORMANCE, RISK, DISPATCH, DELIVERY PERIODS/DATES, DEFAULT

5.1. The place of performance for deliveries is the respective ordering plant of LAUDA MEDICAL.

5.2. Risk shall only pass to LAUDA MEDICAL upon delivery at the supplied LAUDA MEDICAL plant.

5.3. Packaging, dispatch and insurance of the Contract Products shall be at the expense and risk of the Supplier. The Supplier shall also arrange for the return transport of used packaging in accordance with the Packaging Ordinance at its own expense. A delivery note (in duplicate) must be enclosed with each shipment. The Supplier must send LAUDA MEDICAL a written dispatch notification on the day of dispatch. The shipping regulations must be observed. The LAUDA MEDICAL order and article numbers must be stated in all shipping documents, correspondence and invoices.

5.4. Unless a LAUDA MEDICAL logistics guideline has been agreed between the Parties, the Supplier must:

- package, label and dispatch the Contract Products properly with due commercial care, in accordance with the appropriate safety standards and the applicable legal provisions (e.g. minimum wage), as cost-effectively as possible;

- ensure that packaging, outer packaging, packaging aids and goods carriers do not contain hazardous substances and are materially recyclable; and

- comply with the relevant export control regulations and indicate the respective export list position number(s) in accordance with the respectively applicable export control regulations on each order confirmation, each delivery note and invoice, and in particular send long-term supplier declarations (LSD) once a year.

5.5. Complete traceability in the supply chain must be ensured.

5.6. The Supplier must strictly comply with agreed delivery periods and dates, which are understood to be at the agreed delivery location.

5.7. The Supplier must notify LAUDA MEDICAL immediately in writing if it cannot meet agreed delivery periods or dates or if it becomes aware of difficulties with regard to any circumstances that could prevent it from providing timely performance or delivery in the agreed quality. The Supplier must inform LAUDA MEDICAL immediately about the causes and the expected duration of the delay. It can only invoke causes for which it is not responsible if it has complied with this notification obligation.

5.8. Early deliveries, partial and excess deliveries require the prior written consent of LAUDA MEDICAL. In the absence of such consent, LAUDA MEDICAL may refuse to accept these deliveries or return or store them at the expense and risk of the Supplier.

5.9. In the event of culpable delivery default, LAUDA MEDICAL shall have all statutory claims.

5.10. In the event of culpable delivery default, the Supplier must also pay a contractual penalty of 0.3 % of the respective order value for each working day (Monday to Friday) commenced of the default, but no more than 5 % of the respective order value. The possibility of asserting damages exceeding this amount remains unaffected. The contractual penalty shall be offset against the delay damages to be compensated by the Supplier.

5.11. Unconditional acceptance of a late performance does not constitute a waiver of claims for compensation.

6. CONDITION, QUALITY, DOCUMENTATION, SUB-SUPPLIERS

6.1. The Contract Products must comply with all agreed or transmitted product or service-specific requirements and quality requirements by LAUDA MEDICAL or its customers, correspond to a safety standard in accordance with the current state of science and technology and be suitable for the intended purpose. In addition, Contract Products must meet all legal and official requirements.

6.2. The Supplier must carry out careful quality and goods outgoing inspection – also extended to product safety – in accordance with the relevant standards, i.e. in particular comprehensively examine all Contract Products for defects before goods issue and document this.

6.3. The Supplier must retain quality records (in particular with regard to production batches/times, end-of-line testing, outgoing goods inspection and traceability-relevant documents) as well as safety and development-relevant records and documents for a period of at least 15 years.

6.4. The Supplier is only entitled to have its services performed in whole or in part by third parties ("Subcontractors") after prior written consent from LAUDA MEDICAL. The Supplier may only use such Subcontractors and obtain supplies from sub-suppliers who have also been contractually obligated in accordance with the requirements of these PC. Should the Supplier use Subcontractors and sub-suppliers to fulfill its contractual obligations, the Supplier must contractually obligate them and grant LAUDA MEDICAL and its customers a right to audit in their production facilities. The Supplier is liable for defective services and Contract Products of its Subcontractors and sub-suppliers.

7. ACCEPTANCE AND INCOMING GOODS INSPECTION

7.1. If acceptance is required due to the nature of the agreement between LAUDA MEDICAL and the Supplier or the nature of the Supplier's performance obligation or due to legal provisions and nothing else has been agreed on this, acceptance shall take place formally by means of an acceptance protocol after completion and delivery of the Contract Product. A fiction of acceptance through silence on an acceptance request from the Supplier, through payment of the remuneration or through actual commissioning of the work is excluded.

7.2. Unless otherwise agreed in writing, LAUDA MEDICAL limits the incoming goods inspection to a check of the identity and quantity of the delivered products as well as an external visual inspection with regard to obvious transport damage. LAUDA MEDICAL will report defects identified in this process immediately, but no later than within 10 days of their discovery. Other ("hidden") defects will also be reported to the Supplier immediately, but no later than 10 days after their discovery. The Supplier waives the objection of late notification of defects in this respect. Payment of an invoice without complaint does not mean that LAUDA MEDICAL evaluates the respective delivery or the respective Contract Product as being in accordance with the contract.

8. WARRANTY

8.1. The Supplier guarantees the freedom from defects of its Contract Products and the obligations incumbent upon it in this regard. Unless otherwise regulated below or elsewhere, the statutory provisions on material and legal defects apply.

8.2. LAUDA MEDICAL is in particular entitled to demand from the Supplier, at its choice, rectification of defects or delivery of a new Contract Product. The right to compensation for damages, in particular to compensation for damages instead of performance, is expressly reserved. Acceptance or payment for the Contract Products does not constitute recognition of their freedom from defects (cf. already Section 5.11). These are always made subject to reservation. In the event of delivery of defective Contract Products, the Supplier shall bear all resulting costs and damages, in particular costs of fault finding, installation and removal costs as well as transport, travel, labor and material costs, regardless of whether these were incurred at LAUDA MEDICAL itself or at LAUDA MEDICAL's customers or within their distribution organizations.

8.3. The Supplier must indemnify LAUDA MEDICAL from claims that third parties assert against LAUDA MEDICAL in the event of material and legal defects. This also applies if such claims are attributable to defective products and services from Subcontractors or sub-suppliers of the Supplier.

8.4. If the Supplier is in default with the fulfillment of the subsequent performance incumbent upon it, LAUDA MEDICAL may remedy the defects/damages itself or have them remedied by third parties at the Supplier's expense.

8.5. Subject to longer statutory limitation periods, warranty claims become time-barred upon expiry of thirty-six months. The limitation period begins with the transfer of risk (delivery for purchase contracts, acceptance for work performance).

9. PRODUCT SAFETY, PRODUCT LIABILITY

9.1. The Supplier guarantees that the Contract Products are not unsafe and not dangerous within the meaning of the product safety law provisions and product liability for their intended use or foreseeable improper use or consumption. It takes all necessary and appropriate organizational, personnel and technical security measures.

9.2. The Supplier must indemnify and hold LAUDA MEDICAL harmless from all liabilities, costs, damages and expenses that are based on behavior or omission by the Supplier that is not in accordance with the agreement. This includes in particular claims by third parties due to personal injury or property damage caused by a defective or unsafe Contract Product and claims by third parties due to the infringement of (protective) rights.

9.3. If a recall or return action is carried out by LAUDA MEDICAL, one of its customers or a third party to avoid personal injury or property damage based on a Contract Product of the Supplier, it must bear the costs and indemnify LAUDA MEDICAL in this respect. The same applies in the case of quality-related field or service actions. We will inform the Supplier in good time in advance about the content and scope of such a recall measure – insofar as possible and reasonable – and give it the opportunity to comment.

10. INSURANCE

10.1. The Supplier is obligated to ensure appropriate insurance coverage with regard to its obligations.

10.2. The Supplier is obligated to provide proof of the existence of this insurance upon request.

10.3. The Supplier must notify LAUDA MEDICAL immediately in writing of significant changes in insurance relationships, in particular the lapse of insurance coverage or the reduction of minimum coverage amounts. Non-existence and lapse of insurance coverage entitle LAUDA MEDICAL to extraordinary termination or withdrawal from the respective Order.

11. FORCE MAJEURE

11.1. Force majeure, i.e. natural disasters, water ingress, fire, unrest, war, strikes and other unforeseeable, unavoidable for a Party and serious events (e.g. not only temporary production interruptions at customers of LAUDA MEDICAL), release the Parties from their performance obligations for the duration of the disruption and to the extent of its effect.

11.2. The Parties shall inform each other immediately if it is foreseeable that the contractual performance obligations cannot be met as a result of force majeure.

11.3. The Parties are obligated to do everything reasonable to eliminate the disruption and mitigate the effects of the disruption.

11.4. LAUDA MEDICAL is entitled to obtain or have manufactured the Contract Products from other sources for the duration of the delay on the part of the Supplier and to reduce the delivery quantities specified in this Order without any obligation to the Supplier.

12. CONFIDENTIALITY

12.1. The Parties are obligated to keep secret all non-publicly accessible commercial and technical information, knowledge, data and documents, know-how, calculations, methods and processes and other information including such regarding the conditions of the business relationship itself and documents (hereinafter: "Information") that become known to them through the business relationship.

12.2. The obligation exists regardless of whether the Information was communicated orally or in writing. The Information may only be used within the scope of the cooperation and only made accessible to such employees who are necessarily involved and have been similarly obligated to confidentiality. Exceptions to this require the prior express written consent of the other Party.

12.3. The confidentiality obligations under this Section do not exist if and to the extent that the relevant Information is demonstrably generally known, or becomes generally known without fault on the part of the Party obligated to confidentiality, or was or is lawfully obtained from a third party, or must be disclosed due to mandatory regulations.

12.4. The confidentiality obligations contained in this Section continue to apply for an indefinite period even after the expiry or termination of the contractual relationship.

13. SPARE PARTS SUPPLY

13.1. The Supplier must keep spare parts available for the expected service life of the Contract Products, but for at least five years from the end of series production or – insofar as no series delivery takes place – from the respective delivery date for LAUDA MEDICAL. The agreed price for the series parts or the individual order remains in effect for at least three years after termination of series production or delivery of the individual order.

13.2. The Supplier must also maintain the operational state of the production equipment.

13.3. Scrapping during this period requires the express consent of LAUDA MEDICAL.

14. INDUSTRIAL PROPERTY RIGHTS

The Supplier warrants that use or distribution of the Contract Products is permissible without infringement of third-party property rights. The Supplier is liable for claims arising from the infringement of property rights or their registration belonging to third parties in the event of contractual use of the Contract Products. It also indemnifies LAUDA MEDICAL from any legal claims by third parties due to infringement of such third-party property rights in connection with the Contract Products if it is responsible for the breach of duty underlying the property right infringement.

15. SUPPLIED ITEMS, TOOLS

15.1. For designs, molds, tools, samples, illustrations and other documents provided by LAUDA MEDICAL ("Supplied Items"), LAUDA MEDICAL reserves ownership as well as all industrial property rights and copyrights.

15.2. The Supplier may only use such Supplied Items in the manner intended by LAUDA MEDICAL and must return them if LAUDA MEDICAL requests this and/or it no longer needs them for LAUDA MEDICAL.

15.3. Processing and assembly of parts always takes place for LAUDA MEDICAL. The Supplier has no rights of retention to Supplied Items, regardless of the legal basis.

15.4. Tools, molds or other devices that are owned by LAUDA MEDICAL or its customers must be clearly and distinctly marked by the Supplier as third-party property and their storage/location noted in corresponding lists. The tools must be maintained and, if necessary, repaired by the Supplier at its own expense. In addition, they must be insured at the Supplier's expense at least for the replacement value against destruction or damage by forces of nature, fire and water as well as electrical damage. The Supplier must, upon corresponding request, provide access to the tools.

15.5. Tools, molds or other devices that the Supplier manufactures or procures wholly or partly at the expense of LAUDA MEDICAL pass into the ownership of LAUDA MEDICAL. The handover is replaced by the fact that the Supplier stores the items free of charge and carefully for us until the termination of the supply relationship.

16. SET-OFF, RETENTION OF TITLE, RIGHT OF RETENTION

16.1. The Supplier is only entitled to set-off against claims of LAUDA MEDICAL or to assert a right of retention if and to the extent that its claim is undisputed or its counterclaim has been legally established.

16.2. LAUDA MEDICAL is entitled to set off claims of the Supplier also with claims that belong to an affiliated company within the meaning of Section 15 AktG.

16.3. The Supplier is not entitled to assign claims it has against LAUDA MEDICAL or to have them collected by third parties.

16.4. If there is a retention of title in favor of the Supplier for the Contract Products, this retention of title expires at the latest upon complete payment of the respective Contract Products by LAUDA MEDICAL.

16.5. If there is a retention of title in favor of a sub-supplier or another third party for a Contract Product delivered by the Supplier to LAUDA MEDICAL, the Supplier must inform LAUDA MEDICAL before delivery, in written form with precise naming of the beneficiary and the beneficiary's claim, about the retention of title. LAUDA MEDICAL is entitled to release the beneficiary's retention of title by direct performance to the beneficiary, credited against the Supplier's claim.

17. COMPLIANCE

17.1. The Supplier undertakes to always act in compliance with the law ("Compliance"). This includes in particular not committing any acts or omissions that could lead to regulatory or criminal prosecution. This particularly concerns the areas of corruption, money laundering as well as cartel and competition law.

17.2. The Supplier must ensure that its organization is appropriately structured, employees and bodies have been appropriately trained and obligated, and Subcontractors and suppliers have also made corresponding declarations and commitments.

17.3. The Supplier undertakes in particular to take into account and comply with all relevant requirements and provisions on environmental protection and waste disposal in the manufacture and delivery of the Contract Products.

18. AUDIT

18.1. Regardless of whether a Quality Assurance Agreement ("QAA") has been concluded between the Parties, the provisions of this Section 18 apply.

18.2. LAUDA MEDICAL is entitled to determine by audits at the Supplier whether the Supplier's measures to ensure the quality and safety of the products meet the requirements of LAUDA MEDICAL. The Supplier and its sub-suppliers grant domestic and foreign authorities access for conducting inspections, as well as LAUDA MEDICAL's Notified Body access for conducting announced or unannounced audits.

18.3. Each audit can be conducted as a system, process or product audit. The Supplier will enable even short-notice appointment requests in the event of escalation. Reasonable restrictions of the Supplier to protect its knowledge will be accepted and confidentiality assured. If an official inspection or an audit is conducted by the Notified Body, LAUDA MEDICAL must be informed immediately.

18.4. If quality problems occur with the product, assembly or components, the Supplier will provide LAUDA MEDICAL with the opportunity for an audit at its sub-suppliers.

18.5. The result of the audit will be communicated to the Supplier. If deviations are identified, the Supplier undertakes to prepare an action plan coordinated with LAUDA MEDICAL with deadlines, implement these on schedule and inform LAUDA MEDICAL about this.

19. CONTRACT TERMINATION

19.1. Orders designed for an indefinite or not precisely determinable period can be terminated in ordinary fashion by LAUDA MEDICAL with six (6) months' notice to the end of a calendar month in writing. Claims for damages or reimbursement of expenses by the Supplier due to proper termination are excluded. Ordinary termination by the Supplier is excluded.

19.2. The Supplier is not entitled to ordinary termination. The right to extraordinary termination remains unaffected on both sides.

19.3. After termination of the contractual relationship, the respectively exchanged and communicated equipment, documents, tools and all documents and information must be returned or destroyed in coordination.

20. GENERAL PROVISIONS

20.1. When providing services on a LAUDA MEDICAL operating site, the Supplier is obligated to comply with all control and safety regulations applicable there.

20.2. Should a provision of these PC and the concluded individual contracts be or become invalid, this shall not affect the validity of the PC and the individual contracts in other respects. The Parties undertake to agree on a provision instead of the invalid provision or to supplement a contractual gap that comes as close as legally valid as possible to what the Parties would have agreed according to their presumed will, to be determined on the basis of the contractual relationship.

20.3. Amendments and supplements to these PC are only effective in writing. This also applies to this written form requirement.

20.4. The contractual relationships between LAUDA MEDICAL and the Supplier are governed exclusively by German law. The United Nations Convention on Contracts for the International Sale of Goods (CISG) does not apply.

20.5. The exclusive place of jurisdiction for all disputes is Würzburg, Germany.