General Conditions of Purchase

1. General – Area of Application

1.1. The MaiMed Terms and Conditions of Purchase shall apply for all agreements concluded between MaiMed and the supplier regarding the supply of marketable goods and other products. They shall also apply for all future business relations, even if not expressly agreed upon again in writing. Any terms and conditions issued by the Supplier deviating from these Terms and Conditions of Purchase, which MaiMed does not approve in writing, shall not be binding on MaiMed, even if MaiMed does not expressly negate them. The MaiMed Terms and Conditions of Purchase shall also apply if MaiMed accepts the supplier’s delivery without reservation, despite knowing that the terms and conditions of supply contradict or deviate from the MaiMed Terms and Conditions of Purchase.

1.2. Any agreements concluded between MaiMed and the supplier in connection with the preparation and conclusion of purchase agreements must be in writing, even for electronic data interchange. Such agreements shall be specified by MaiMed at the end of the respective purchase agreement, these Terms and Conditions of Purchase and the underlying quotations (orders).

2. Quotation, conclusion of contract

2.1. MaiMed shall be bound by a quotation/order for the conclusion of a purchase agreement for a week from the date of quotation. The supplier shall be required to accept the quotation/order through issuing a written declaration to MaiMed within that week.

2.2. Quotations from the supplier shall be binding in every respect, in particular with regard to availability/delivery lead time, and must be issued in “EUR” or “USD”. MaiMed is unable to enter into a contractual relationship based on a different currency. Unless expressly agreed otherwise, the prices quoted by the supplier shall be understood as free delivery to the Neuenkirchen central depot or locations specified by MaiMed.

2.3. MaiMed orders shall be issued exclusively in writing and shall require two signatures. The supplier shall be required to sign declarations of acceptance or order confirmations with legally binding effect.

2.4. Upon conclusion of contract, the relevant layouts and other documents applicable for the MaiMed order shall form part of the contract. The MaiMed order number must be specified in any correspondence, invoices and shipping documents (wagon labels, bills of lading, delivery notes, express delivery receipts, package dispatch slips, etc.). At MaiMed’s request the shipment destination must also be recorded. In the event of products being misrouted due to failure to comply with these provisions, the supplier shall be liable for any costs incurred thereby (demurrage, switching charges, etc).

2.5. Changes or additions to the MaiMed order, the supplier’s quotation or the contract concluded, in particular with regard to price and delivery quantity, shall only be effective upon written confirmation by MaiMed.

2.6. MaiMed reserves the right of ownership and copyright over all layouts, diagrams, drawings, calculations, samples, data sheets and other documents forming the basis of the purchase order. Such documents shall be used solely for performance of the respective delivery. Upon completion of the contract they are to be automatically returned to MaiMed. The contents of such documents shall not be disclosed to third parties without MaiMed’s express written approval, unless the information contained therein is general public knowledge. This confidentiality obligation shall continue to apply even after termination of the contract.

2.7. Certificates of origin and supplier’s declarations pursuant to Council Regulation (EC) No 1207/2001 and other evidence of origin required shall be provided by the supplier, upon demand, for the goods delivered by the supplier, with all conceivable information necessary, or the said documents shall be procured and duly made available to MaiMed. Should this prove impossible in a specific case, “not eligible for preferential treatment” shall be indicated on the declaration of acceptance/order confirmation.

2.8. In the event that price adjustment clauses are nevertheless agreed over the time between conclusion of contract and delivery of the goods, the following shall apply: any price increase, in particular due to changes in market prices for raw materials, must be substantiated; price increases must be announced three months in advance; price reductions must be applied with immediate effect. In the case of call orders MaiMed requires the supplier to hold sufficient stocks for full performance of the contract.

3. Delay in delivery, contractual penalty and documents

3.1. The delivery lead time or delivery date specified by MaiMed at the time of placing the order shall be binding on the supplier.

3.2. Should the supplier become aware of circumstances or factors potentially threatening or making impossible compliance with the delivery deadline, the supplier shall notify MaiMed forthwith, specifying the reasons and the anticipated delay. This, however, shall not affect the supplier’s obligation to perform delivery on time upon a decision being made with regard to compliance with MaiMed’s order.

3.3. For an order to be considered complete an inspection certificate and/or a certificate of analysis must, where agreed, be provided within the deadline set; for sterile products a certificate of sterility must be automatically provided with each delivery.

3.4. Notwithstanding the right to compensation for additional damages, MaiMed shall be entitled to claim flat-rate default compensation in the event of a delay in delivery, amounting to 0.2% of the value of the delivery for each calendar day of default, up to a maximum of 12% of the value of the delivery. The supplier shall be entitled to present evidence to MaiMed proving that the supplier is not responsible for the delay and/or that no or no significant loss or damage ensued as a result of the delay, in which case the flat-rate default compensation shall be reduced accordingly.

3.5. Should the supplier fail to perform delivery, even after a reasonable extension, MaiMed shall be entitled to demand damages for non-performance, taking into account the flat-rate default compensation, or to procure replacement from a third party or to withdraw from the contract. Should MaiMed incur loss or damage in obtaining the missing goods from a third party, MaiMed shall be entitled to charge the relevant amount to the supplier.

3.6. The supplier shall only be entitled to claim force majeure provided that the supplier notified MaiMed forthwith of the factors or circumstances substantiating force majeure and provided that the supplier was not already in default at the time when the force majeure came into effect.

3.7. Partial deliveries and early deliveries are to be avoided, but, where unavoidable, must be agreed with MaiMed.

4. Obligation to take delivery

4.1. Unforeseen events such as force majeure, war, governmental action and nonculpable operational stoppages shall relieve MaiMed of the obligation to accept the ordered delivery. The supplier shall not be entitled to claim compensation in this case.

4.2. In the event of other operational stoppages, MaiMed shall be entitled to request a reasonable extension of the acceptance deadline.

5. Shipping documents and payment

5.1. Each delivery of goods must be accompanied by a delivery note, specifying the order number and item number, a list of the (sterilisation) batches, a description of the goods, the quantity delivered (specifying the units thereof), weight (gross and net), the bank details and the customs tariff number. For deliveries from non-EU countries a duplicate of the invoice must be attached to the delivery note. In the event of preferential trade agreements or trade agreements between the Federal Republic of Germany and the country of origin, certificates of origin confirmed by the competent authorities must be attached to the deliveries. The supplier must issue an invoice for each delivery and send it in duplicate to the parent company in Neuenkirchen, irrespective of the place of delivery within Germany. The invoice must clearly indicate in particular the MaiMed order no., item no. and article no.

5.2. The respective customs tariff number must be indicated for the country of receipt. MaiMed shall be entitled to compensation in the event of failure to comply with this obligation or false declaration.

5.3. Payment shall be effected in the customary commercial manner, namely within 10 days for a 4% discount or within 30 days for a 2.5% discount, or after 60 days strictly net, from delivery/performance and receipt of invoice in the (weekly) payment run following maturity, using a means of payment selected by MaiMed.

5.4. Invoices containing errors or omissions shall not be payable and may be returned by MaiMed at any time. In such cases, the due date shall be calculated from receipt of the revised invoice. The payment period shall be suspended if delivery documents are missing or if the invoice is sent to a site other than the site specified in the order or in the event of incomplete or incorrect information, until such time as the revised invoice and other complete documents required are received. The duration of the suspension of invoice verification shall be taken into consideration in any late payment assessment, without the loss of rebates, discounts and other price concessions. In the event of premature receipt of deliveries, the payment period shall not begin until the delivery date specified in the order or the invoice date – whichever is later.

5.5. The supplier shall only charge VAT if entitled to do so under the provisions of the German VAT Act. Where the tax office does not authorise deduction of VAT invoiced by the contractor or the said VAT has to be repaid to the tax office, the supplier, as the invoice issuer, undertakes to immediately pay back VAT already received to MaiMed.

6. Transportation, packaging and layout

6.1. All deliveries to MaiMed shall be performed in accordance with Incoterms 2010.

6.2. Unless agreed otherwise, deliveries shall be Carriage Paid To.

6.3. If the supplier takes on carriage for MaiMed, MaiMed shall only accept the lowest possible freight costs. The other terms of delivery shall be governed by MaiMed’s specifications.

6.4. The delivery must be packaged in such a way as to avoid damage in transit. If separate calculation of the packaging has been agreed on, the costs for such packaging shall be listed separately in the quotation, order confirmation and invoice.

6.5. The supplier shall only use recyclable and high-grade packaging materials, marked with the appropriate symbols.

6.6. The supplier undertakes to take back the packaging materials or to authorise MaiMed to dispose of the packaging materials or arrange for disposal thereof and to bill the costs incurred by MaiMed in connection therewith to the supplier. At the end of each quarter, 0.1% shall be billed on the invoiced amount in the supplier’s invoices.

6.7. In cases where MaiMed pays the supplier in full or in part for production equipment (e.g. tools, pressure plates), ownership thereof shall transfer to MaiMed.

6.8. MaiMed shall be entitled to perform a free layout change every 6 months.

6.9. The supplier shall be entitled to procure packaging materials for single orders which do not exceed one percent of the order quantity.

6.10. If a call order has been concluded between MaiMed and the supplier, the supplier shall be entitled to procure packaging materials in advance amounting to no more than 50% of the order volume. Unused MaiMed packaging units must not be brought into circulation elsewhere on the market after completion of the supply contract.

7. Quality

7.1. The supplier shall be responsible for ensuring (in accordance with Section 434(1)(1) of the German Civil Code), that the products delivered are in a marketable and usable condition and comply with the agreed quality requirements (e.g. specifications, descriptions, product pass, data sheets, product requirements document, drawings, samples, analysis).

7.2. The supplier shall guarantee that the goods comply with the regulations applicable for such goods and the products for production of which the goods are used (to the supplier’s knowledge). The regulations referred to above shall be taken to refer to all forms of legislation, European standards, DIN standards, pharmacopoeia monographs and other recognised technical regulations, in particular the specifications agreed with the supplier. If the goods come under the German Food and Commodities Act, the supplier shall guarantee that neither the goods nor their follow-up products or contaminations are noxious when used as directed and as foreseen, and that the goods are therefore physiologically harmless. If a recommendation is issued for the goods by the Plastics Committee of the German Federal Office for Consumer Protection and Veterinary Medicine, the supplier shall guarantee that the goods comply with the latest version of the relevant recommendation. The supplier shall guarantee compliance with these provisions for each delivery and shall provide further documentation and validation documents upon request. The supplier shall perform stateof- the-art quality control, commensurate to the type of article and volume thereof and shall provide MaiMed with evidence of having done so on request.

7.3. MaiMed shall be entitled to inspect the agreed quality and marketability of the products, including the components, composition and quality thereof, and shall be entitled to make use of specialist third parties for this purpose. The latter shall be bound by a confidentiality obligation. The supplier shall bear the costs of the said inspection. MaiMed shall be entitled to refuse and return the products at any time if the products do not satisfy the agreed quality requirements.

7.4. If MaiMed detects defects or deviations from the agreed quality requirements in the products delivered, the supplier shall immediately conduct fault analysis. The supplier shall notify MaiMed without delay of the cause of the defect or deviation.

7.5. If the product is a medical device, the product-specific EU standards, the German Medical Devices Act and in particular Council Directive 93/42/EEC, as amended, shall apply for production of such items.

8. Warranty and indemnification

8.1. The supplier shall perform an outgoing goods inspection, which shall serve the same purpose as a legally required incoming goods inspection, as defined under Section 377 of the German Commercial Code. For this purpose random samples shall be taken, which shall be recorded in inspection logs and attached to the delivery.

8.2. MaiMed’s legal obligation to inspect incoming goods shall be limited to inspection of goods in terms of quantity, type, externally visible defects (such as damage in transit) and other obvious defects. MaiMed shall be required to notify the supplier of visible defects without delay, within 14 working days of delivery or provision. The supplier undertakes to provide free replacement and compensation for any loss or damage incurred in the event of defects which are not apparent at the time of delivery but emerge following laboratory testing, processing or use of the goods.

8.3. MaiMed shall be exempt from any further obligations under Sections 377 and 379 of the German Commercial Code; the applicable provisions of the German Civil Code shall continue to apply. Section 476 of the German Civil Code shall apply accordingly with regard to burden of proof.

8.4. If confirmed with the supplier during the ongoing commercial relationship, the supplier shall be required, where reasonable, to point out changes to the specifications, the manufacturing process, the recommended application and the packaging, in sufficient time prior to delivery to allow MaiMed to perform adequate inspection of the changes, e.g. through inspection at the supplier’s place of business. Notification with respect to changes in the data sheets to be provided must be provided in writing by no later than the time of delivery.

8.5. If the delivery is defective, MaiMed shall have access to its full statutory rights. MaiMed shall be entitled in particular to demand either replacement of the defect or new delivery/manufacture, as it sees fit. The supplier shall bear the costs of such replacement or new delivery/manufacture, including costs incurred for delivery to a location other than the original place of performance.

8.6. The supplier shall be responsible for ensuring that the supply, use and operation of the subject-matter of delivery do not breach patents, copyright, trademark rights or other intellectual property rights. The supplier shall hold MaiMed harmless against any third-party claims brought against MaiMed for breach of the said intellectual property rights as a result of the delivery. The above shall encompass, in particular, protection against unjustified claims and compensation for any expenses.

8.7. Irrespective of its other claims, the supplier shall indemnify MaiMed, on first request, against any third-party claims, in particular due to product and manufacturer liability, where these can be brought against MaiMed because the origin lies within the supplier’s sphere of organisation and control, and the third party could therefore have asserted such claims against the supplier instead of MaiMed. The above shall encompass, in particular, protection against unjustified claims, compensation for any expenses and costs associated with protective measures.

8.8. Claims for defects shall become statute-barred within three years of the start of the statutory limitation period. Notification of a defect issued within the limitation period shall interrupt the limitation period until an agreement has been reached between MaiMed and the supplier on rectification of the defect and any consequences. The said interruption shall end, however, six months after final rejection of the notification of defect by the supplier.

9. Customer protection

9.1. The supplier undertakes to refrain from any form of competition with respect to MaiMed’s customers and not to operate for the customer in any way, whether directly or indirectly, or to accept orders from the customer. The said customer protection shall cover all OEM contracts for a period of 5 years following completion of the contract. Direct conclusion of any successor agreements shall require express individual agreement from MaiMed.

9.2. In the event of breach of the customer protection agreement, the supplier undertakes to pay MaiMed a contractual penalty amounting to average annual turnover. The supplier also undertakes, in the event of a breach of the customer protection agreement, to provide MaiMed with all information required about the order(s) concluded directly with the customer. This shall not affect MaiMed’s right to claim compensation and to demand that the supplier desists from such actions.

10. Child labour

MaiMed does not tolerate child labour. In the event of acceptance of an order, the supplier undertakes not to employ any child labour at the supplier’s company. Employees must not be under the age of 15 (or 14 if the country of manufacture so allows), or where the minimum age is higher than 15 in the country of manufacture, must not be under the minimum age at which compulsory education ends.

11. Place of performance, place of jurisdiction and applicable law

11.1. The place of performance shall be Soltau/Germany.

11.2. The place of jurisdiction shall be Soltau/Germany.

11.3. The contractual relationship shall be governed by and construed in accordance with the laws of the Federal Republic of Germany, even for deliveries from abroad. The contractual language shall be German.

11.4. Should any of the provisions of these Terms and Conditions of Purchase be or become invalid, this shall not affect the validity of the other provisions. The invalid provision shall be replaced by a legally admissible provision which matches as closely as possible the economic consequences of the original provision.

11.5. If the supplier’s registered office is outside the Federal Republic of Germany the following shall apply: written notification and declarations to the supplier shall be sent to the last address provided by the supplier. If a time-limit is set for such declarations, it shall be considered sufficient for compliance with the time-limit that the letter is posted with the correct address within the time-limit. If service is required for a notification or declaration to be effective, a letter shall be considered as having been served four days following postage, unless demonstrably received earlier.