Standard Business Conditions

1. General

1.1 These general terms and conditions of business and delivery shall apply for all services and deliveries that Wiewelhove GmbH (hereinafter referred to as "WV") provides in connection with an order for the production and testing of products and services rendered to a natural person or legal entity or to a legal partnership acting in the exercise of their commercial or independent professional activity for conclusion of the contract (contractor – hereinafter referred to as the "customer").

1.2 WV hereby expressly rejects all conflicting, differing or supplementary conditions from the customer unless WV has expressly consented, in writing, to their application. Our terms and conditions shall also apply if we perform services and deliveries without reservation in the knowledge of the existence of the customer’s contradictory or differing terms and conditions.

1.3 Our terms and conditions shall also apply for all future business with the customer without WV referring to them in each individual case. The version valid at the time of conclusion of the contract always applies. Differing, individually negotiated agreements take precedence over these terms and conditions.

2. Conclusion of contract/order

2.1 Our quotes are subject to change and non-binding, unless we have expressly indicated that they are binding.

2.2 By ordering the desired delivery or service, the customer declares its contract offer to be binding. The customer shall be bound by its orders and other declarations 14 calendar days from receipt by WV. WV shall only accept the order with the written order confirmation, including through sending of emails in text form.

2.3 Unless otherwise stipulated in the contract, the contractor may utilise, employ, sell or distribute the WV products worldwide with the exception of Brazil, Canada and the United States of America, including their respective territories and dependent territories ("contractual area").

2.4 Where necessary, WV and the customer’s technical and pharmaceutical responsibilities in relation to the execution of an order are regulated in a separate agreement defining responsibilities ("VA agreement").

2.5 The conclusion of the contract is subject to the condition that its fulfilment is not impeded by national or international regulations, in particular export control regulations as well as embargoes or other sanctions (e.g. in the context of international disputes or wars).

2.6 If the customer withdraws from a contract which has already been concluded without justification, then we shall be entitled to claim 20% of the gross sales price for the damages caused by withdrawal, without prejudice to the possibility of claiming for higher actual damages. The customer shall bear responsibility for proving that WV has suffered no damages or only minor damages owing to order cancellation.

2.7 We retain ownership, copyright and other proprietary rights to all formulas, calculations, estimates and other documents which we have produced and which are entrusted to the customer and its employees, as well as the associated information which we have communicated. Transmission to third parties is only permitted with our written consent, regardless of whether we have identified the content as confidential.

3. Procurement

3.1 If the customer is responsible for the procurement of raw materials, components, source materials and/or packaging materials (materials), then the customer shall bear the costs and risk for the delivery of the materials to WV’s business address. The customer must provide materials of sufficient quality in sufficient quantities in time for WV to be able to make the necessary and requisite preparations for the fulfilment of the order.

3.2 Unless expressly provided otherwise in a VA agreement, WV shall be under no obligation to control or test materials provided by the customer or which are procured by WV, unless there are apparent defects in these materials.

3.3 Materials supplied to WV by the customer shall remain the property of the customer. WV shall have a right of retention to the amount of double the services provided for services which have already been provided.

4. Information and material contractual obligations

4.1 The customer must provide WV with all of the information required for fulfilment of the order as well as information regarding the products and materials at its own expense in accordance with the legal requirements. This obligation to provide information includes appropriate documentation, instructions, formulations, work instructions, specifications, progress reports, processes and registrations (information) and, in particular, covers any changes to this information from the contractor. WV shall prepare production specifications on the basis of the customer's information, which must be signed by the customer. By signing the production specifications, the customer confirms that the production specifications are appropriate for the fulfilment of the order. The customer is responsible for ongoing agreement between the current production specifications and the customer's information. The customer shall be required to provide immediate notification of changes to the information. WV may therefore rely on the correctness and completeness of the information provided by the contractor, unless there are indications that this is not the case. The customer shall bear all costs and expenses incurred by WV as a result of failure to communicate the necessary customer information and/or changes to it in a timely manner.

4.2 Unless otherwise stipulated in the order, WV shall fulfil the order in accordance with the production specifications, the customer's information and German law.

5. Regulatory compliance and audits

5.1 The Customer shall ensure, at its own expense, that all necessary and required regulatory permissions, licences, permits and approvals are obtained and maintained for the respective products as well as for their production, utilisation, employment, sale and distribution. These costs include, in particular, all costs and expenses arising from product-related regulatory inspections at WV (e.g. "pre-approval inspections").

5.2 The customer shall be entitled to audit the WV sites at which the product is manufactured. Audits should be carried out at most every three years unless a previous audit or critical event reveals non-conformance. The customer shall announce the audit in writing in an appropriate manner and conduct it during normal business hours. However, the customer's right to audit shall not under any circumstances extend to areas, documents or information that are not related to the product and/or the fulfilment of the order. If an audit relates to a third party and/or to materials provided by a third party, then WV’s duty of confidentiality other customers and/or the contractual customer shall always take precedence. Furthermore, WV may edit documents which are provided to the customer insofar as they contain information about third parties and/or materials provided by third parties.

6. Delivery

6.1 The basic delivery conditions are "FCA Ibbenbüren Incoterms 2020", unless otherwise agreed in individual cases. If additional costs are incurred as a result of another agreement, these shall be borne by the customer.

6.2 Delivery dates which are not part of the order in writing or in text form are not binding. The delivery period begins only after any questions relating to the characteristics of the products or the customer’s particular requirements have been clarified with the customer. Likewise, the customer must fulfil its obligations properly and in good time and must comply with the obligations and duties of cooperation for the performance of agreed inspections by WV.

6.3 In the event that a delay in delivery attributable to WV is due to culpable violation of a material contractual obligation, whereby fault by WV's representatives or vicarious agents can be attributed to it, WV shall be liable in accordance with the legal provisions subject to the proviso that, in this case, liability for damages shall be limited to the foreseeable, typically occurring damage. If there is no breach of a material contractual obligation as a result of the delay in delivery, we shall only be liable in accordance with this provision in the event of intentional or grossly negligent action or omission.

6.4 WV shall be entitled to provide partial deliveries and partial performances within the delivery dates/periods we have specified, insofar as this is not unreasonable for the contractor.

6.5 If the customer is in default of acceptance, WV shall be entitled to demand compensation for the damages incurred and any additional expenses, e.g. disposal costs, replacement of materials/raw materials and their processing for the product which has already been manufactured. The same shall apply if the customer is in culpable violation of the duty of cooperation. The risk of accidental degradation and accidental loss shall pass to the customer upon occurrence of default of acceptance or payment.

7. Acceptance, prices, payment and transfer of ownership

7.1 The customer is obliged to accept products which are the subject of an order. If WV is required to procure specific materials for the fulfilment of the order, then the customer's acceptance obligation shall also extend to these materials regardless of whether they have become part of the contract or not.

7.2 Products shall be subject to the sales prices agreed in the order (per 1000 units) while materials must be purchased at the purchase prices plus ancillary costs. The unit determined by WV shall be decisive for the calculation. Unless otherwise stipulated in the order, the prices shall be ex works at Dörnebrink 19, 49479 Ibbenbüren (FCA, Ibbenbüren Incoterms 2020) plus taxes, legal fees and charges.

7.3 WV may invoice after delivery of the products in accordance with Clause 6.

7.4 The customer shall be required to settle invoices within 14 calendar days. Payments shall be made without deduction and in euros and shall be effected by means of wire transfer. Upon receipt of payment, WV must have access to the invoice amount immediately and at any time. The WV account which is specified on the written WV invoice shall be valid. If payment is not received within the term, then WV shall be entitled to charge the legally permissible maximum interest rate.

7.6 If materials the customer’s materials are processed, combined or mixed with WV materials, then the contracting parties shall acquire co-ownership in relation to the invoice value of the materials they have provided respectively. (Full) ownership of the product shall pass to the customer upon payment in full for the corresponding material/goods.

8. Warranty

8.1 Upon receipt of the goods or services, the customer must inspect the products immediately, with particular attention to identity and visible external transport damage.

8.2 If the product is defective, then the customer must report the defect to WV within 14 calendar days following delivery of the product. In the event of concealed defects or defects which cannot be found during routine inspection, the customer must notify WV of them no later than seven calendar days after discovery.

8.3 The warranty period shall be 12 months, unless otherwise agreed. It shall begin upon transfer of risk in accordance with Clause 6. Goods and deliveries which are not rejected by the contractor in a timely manner in accordance with Clause 8.2 shall be considered to be inspected and accepted.

8.4 In the event of a warranty claim, WV shall be entitled to decide, on a case-by-case basis, whether to provide rectification, where possible and permitted by law, provide a replacement or refund the price. WV shall be entitled to have goods or deliveries which have already been made returned. Provided that WV has not violated its obligations and the product will be newly manufactured, WV shall be entitled to normal costs, such as disposal costs, material and wage costs for the product which was already manufactured, costs resulting from replacement of the raw materials or material and wage costs.

Otherwise, the statutory provisions shall apply.

9. Liability

9.1 WV shall be liable without limitation, in accordance with the statutory provisions, for injury to life, body and health resulting from negligent or deliberate breach of duty by WV, its legal representatives or its vicarious agents. Furthermore, WV shall be liable, irrespective of cause, for damages caused by negligent violation of a material contractual obligation by WV. Material contractual obligations are fulfilment of the order in accordance with the production specifications, the customer's information and German law, as well as those obligations which must be fulfilled in order to make proper fulfilment of the order possible at all. WV’s liability for negligent conduct shall be excluded in all cases other than those specified above.

9.2 WV’s liability owing to negligent violation of a material contractual obligation as specified in Clause 9.1 shall be limited to the extent of damage which WV must typically expect to occur upon conclusion of the contract. In the event of loss or damage to the materials provided by the customer, WV shall provide compensation for damages to the amount of the proven purchase value of the materials.

9.3 Unless the parties have expressly agreed otherwise in writing or in text form, WV shall not assume any additional contractual or non-contractual warranty or liability, nor shall it give any further guarantees or assurances

9.4 Insofar as WV’s liability is limited or excluded, this shall also apply for its salaried employees’, directors’, employees’ and authorised representatives’ liability.

10. Indemnity for WV

10.1 The customer undertakes to indemnify WV and its directors, salaried employees, employees and authorised representatives against all claims and expenses arising from or in connection with use by third parties, insofar as these claims and expenses result from the fact that the development or design of the product was flawed (development risk), the product was utilised, employed, sold or distributed outside the sales area or a patent, a trademark or other third-party intellection property was violated as a result of the materials and information provide by or on behalf of the customer or their use or exploitation by WV or as a result of the utilisation, employment, sale or distribution of the products.

11. Force majeure

11.1 Any kind of force majeure, in particular natural phenomena, fires, floods, explosions, storms, earthquakes, pandemics, riots, unforeseen energy, raw materials and auxiliary goods shortages, unforeseen operational, traffic and shipping disruptions, sabotage, lawful strikes, lawful work stoppages, lawful lockouts, lawful industrial action, administrative or court orders, ordinances implemented by local or regional legislators, embargoes, (declared or undeclared) war in the area of activity, invasion, export, terrorism or any other cause which is outwith the reasonable control of the party obligated to provide services shall release this party from the obligation to provide performance and acceptance for the duration and to the extent of the disruption.

11.2 If a party invokes a force majeure event in accordance with Clause 11.1, then it must inform the other party of this immediately. At the same time, it must take appropriate and standard measures, as well as customary measures, to remedy or limit the disruption. If the disruption lasts for more than six months, then both parties shall be entitled to withdraw from the contract. However, there shall be no claims for damages in this respect.

12. Confidentiality and intellectual property

12.1 Each party is required to keep confidential information provided to it by the other party in connection with fulfilment of the order strictly confidential. The parties shall conclude a separate confidentiality agreement to this end.

12.2 Each party shall remain the sole owner of all of its intellectual property, including its know-how, copyrights, patents, trademarks and trade secrets, as well as its other intellectual property, which existed before the contract was concluded, regardless of whether a patent has been registered or whether a patent exists. No claims can therefore be derived from this on either side, unless otherwise agreed.

12.3 WV shall be entitled to the ownership of and all rights, including intellectual property rights, to the inventions, discoveries and improvements made by WV during production of a particular product, as well as the know-how acquired.

13. Retention of title

13.1 The goods shall remain the property of WV until all receivables have been paid in full, unless otherwise stated below:

13.2 The customer's claims arising from the resale or further processing of the goods supplied by WV shall be assigned to WV in advance with all ancillary rights. In the event that goods which are subject to retention of title are sold by the customer together with other materials not owned by WV, the assignment of the claim or claims shall apply only to the value of the goods supplied by WV. If processing is carried out with objects not owned by WV, then WV shall acquire co-ownership of the new object in relation to the value of the goods supplied by WV proportional to the other processed objects. The same shall apply if the goods are mixed with other objects which do not belong to WV.

13.3 If WV has provided services in relation to the order as well as production services, then WV shall be entitled to a right of retention against the customer to the amount of the outstanding claims.

13.4 Offsetting of WV's claims with the customer’s claims shall only be permissible if the customer’s claims have been upheld by a court of law or are undisputed.

13.5 Claims or other rights of one party pursuant to the order shall not be acceptable without the prior consent of the other party.

13.6 The customer shall only be entitled to resell or process the goods delivered by us in the normal course of business and with the proviso that the purchase price, service or wages claim from the resale shall pass to WV in accordance with the above provisions. If the purchaser is in default in fulfilment of its obligation to pay, it may only dispose goods which have not been fully paid for with the express consent of WV.

13.7 The customer shall be authorised to collect the claims from the resale despite the assignment. WV’s authority to collect shall remain unaffected by the customer’s authorisation to collect. However, WV shall not collect the claim itself provided that the customer fulfils its payment obligations. At WV's request, the customer shall be required to notify the third party of the assignment and to hand over the necessary documents to WV in order to assert the rights against the third party.

13.8 WV’s retention of title shall be conditional such that ownership of the reserved goods delivered by WV shall pass to the customer without further ado upon payment in full of all WV claims arising from the business relationship and the assigned claims shall be conceded to the customer. WV undertakes to release the securities to which it is entitled pursuant to the above provisions – at WV’s discretion – insofar as their value exceeds the claims to be secured by more than 10%. This shall be subject to the proviso that the securities must be released for deliveries or replacement values which have themselves been paid in full.

13.9 In the event of resale of the goods supplied by WV which are subject to retention of title, the buyer shall also agree retention of title with its customer such that WV’s ownership is maintained.

13.10 The customer shall be required to take out adequate insurance to cover the WV goods in the event of damage by the elements, in particular fire, water, storms and hail, as well as damage resulting from burst pipes and theft, and shall provide us with proof of insurance upon request. The goods must be stored such that the retention of title remains effective.

14. Insolvency/bankruptcy/deterioration of the customer’s financial situation

In the event of insolvency, bankruptcy/compulsory liquidation proceedings or deterioration of the customer's financial situation (e.g. owing to foreclosure against the client) affecting a substantial portion of the customer's assets, WV shall be entitled to make fulfilment of the order dependent on the client providing adequate collateral (value of the agreed service). If the customer does not provide adequate collateral despite the request, WV may withdraw from the order.

15. Applicable law/jurisdiction/place of fulfilment

15.1 German law shall apply.

15.2 The sole place of jurisdiction for all disputes between the parties arising from or in connection with an order and/or their business relationship shall be Ibbenbüren, Germany.

15.3 The place of fulfilment shall be Ibbenbüren.