valid for: all export countries (except Germany/ Austria/ Switzerland)

1. These General Terms and Conditions of Sale, Delivery, Export and Payment (hereinafter also referred to as “GTC”) shall apply to all – including future – offers, acceptances of offers and order confirmations for the delivery of goods as well as project services, such as development work, contract manufacturing, including documentation by ROTOP Pharmaka GmbH (hereinafter referred to as “ROTOP”), unless they are expressly amended or excluded in writing. ROTOP objects to any terms and conditions or contract modifying provisions of the contract partner; they shall only become effective if ROTOP agrees to them in writing.

Where reference is made in this paragraph 1 or subsequently in these GTC to the written form or to declarations to be transmitted in writing or agreements to be concluded in writing, this refers both to the transmission of declarations and the conclusion of agreements in writing and to the transmission of declarations and the conclusion of agreements in textual form.

2. Offers, orders or contracts of the contract partner (“Order”) must be made in writing and must contain the following information: product designation, desired batch size, delivery address, delivery date, invoice address (if different), VAT number and the number of vials per country of sale and the corresponding valid prices, if ROTOP is responsible for the packaging.

3. Orders shall only be deemed accepted if ROTOP declares its acceptance in writing (“Order Acceptance/ Order Confirmation”). If the Order Acceptance deviates from the Order, for example because an Order has not been placed within the agreed order and delivery deadlines, the Order Acceptance shall be deemed to be a new order which must be confirmed again in writing by the contract partner. When ordering for the first time, the ROTOP Master Data Sheet, which shall be provided to the contract partner by ROTOP, must be filled in completely – for subsequent Orders, specifying the customer number issued by ROTOP and, if necessary, the internal order number will be sufficient.

4. In case of contractually agreed down payments, the Order Acceptance is subject to the condition precedent of receipt of the agreed down payment. If there are delays in this process, the planned delivery date may be delayed accordingly without ROTOP being in default of performance.

5. Orders of the contract partner may be cancelled by the contract partner free of charge – irrespective of an Order Acceptance by ROTOP – within ten (10) working days after receipt of the respective Orders by ROTOP. Thereafter, they are binding, and cancellation is excluded.

6. For deliveries and services within the EU, the contract partner shall inform ROTOP of its respective value added tax identification number under which it will be taxed on its income before the start of delivery. For deliveries and services outside the EU, the contract partner shall provide ROTOP with the export certificate required for tax purposes.

7. The timing of the deliveries and services to be provided by ROTOP depends on the respective contractual agreement.
Deliveries and services are therefore either – in case of a respective agreement – based on rolling forecasts or on the deadlines specified in the accepted Orders or Contract. Other declarations by ROTOP regarding the delivery and service deadlines to be met are non-binding. A written agreement on dates or deadlines is non-binding insofar as delays are due to difficulties in the procurement of raw materials by ROTOP.

In case of a written agreement on a delivery or service period, such period shall generally begin upon dispatch of the written order confirmation, but not before receipt of the supporting documents to be provided by the contract partner according to law or contractual agreement, clarification of all technical issues regarding the services to be provided by ROTOP and as the case maybe receipt of payment of an advance payment agreed upon in writing by ROTOP.

Deliveries by ROTOP shall be EXW (INCOTERMS 2020) unless otherwise agreed in writing. In this respect, a delivery by ROTOP shall be deemed to have been made on time or on schedule when ROTOP has notified the contract partner that the goods are ready for shipment (collection by the contract partner).

If the contract parties have agreed in writing that the goods are to be delivered by dispatch, the dispatch is always at the risk of the contract party, even if delivery is free of charge. In such cases, delivery by ROTOP shall be deemed to have been made on time if the goods have been handed over to the forwarding agent, carrier or other third party commissioned with the transport no later than the day of the expiry of the deadline or date. In this respect, it is pointed out that there is regularly no shipment on Fridays, Saturdays, Sundays, on public holidays and on days before public holidays. If an agreed deadline expires on a Friday, Saturday, Sunday, public holiday or on a day before a public holiday, the deadline shall be extended until the following working day. A public holiday is any holiday at the registered office of ROTOP and the contract partner.

The contract partner is obliged to sign acknowledgements of receipt or refusals of acceptance immediately upon delivery of the goods, adding the name of his employee involved, the date and time.
If the delivery or service is not accepted, the contract partner shall bear the costs incurred by the delayed acceptance. In the event of a delayed acceptance of more than 10 days, these shall amount to at least 0.3% of the net order value. The assertion of a claim for damages in excess thereof shall remain unaffected.

If the contracting partner fails to comply with a duty to cooperate agreed in writing or resulting from the law, ROTOP is entitled to demand compensation for the damages which incur as a result, including any additional expenses. ROTOP reserves the right to assert further claims or rights.

8. All substances and materials provided by the contract partner for rendering the services owed by ROTOP, e.g. Active Pharmaceutical Ingredients/Drug Substance Precursor (APIs/DSP), must meet the requirements of the respective legal or other regulations and quality standards, e.g. EU-GMP Guide, European Pharmacopoeia (Ph. Eur).

9. The following applies to all deliveries of products: ROTOP may make partial deliveries, unless such are expressly excluded by contractual agreement. The quantity of the ordered goods stated in the Order Acceptance may be exceeded or fall short by up to 10 % due to production.

10. The contract partner shall be responsible for the proper disposal of the packaging material. If ROTOP is to take back packaging material for disposal or storage, this requires a separate written agreement. However, ROTOP is entitled to demand the return of the packaging material – especially in the case of radioactive goods/type A containers – carriage paid to the shipping point. ROTOP shall exercise this right in writing at the latest at the time of delivery.

11. In principle, the price list valid at the time of delivery and provision of services shall apply, subject to any deviating prices stated in the accepted Order or agreed otherwise in writing. All prices are EXW (Incoterms 2020) quoted in Euro, excluding the statutory value-added tax, packaging and shipping costs and transport packaging (such as GDP certified boxes, use of cooling elements, data loggers), which the contract partner must pay additionally to ROTOP.

Unless a fixed price agreement has been made, ROTOP reserves the right to increase the prices appropriately if, after the Order Acceptance, cost increases occur due to price increases outside ROTOP’s control (such as exchange rate fluctuations, currency regulations, significant increases in material or manufacturing costs) or due to price increases by suppliers. In this case, ROTOP shall notify the contract partner of the price increase in due time before delivery or performance of the service. Furthermore, the price increase shall only be permissible to the extent that it is necessary due to the general external price increase outside of ROTOP. In return, ROTOP assures a price reduction if the aforementioned costs are reduced.

12. If the goods to be delivered require transport under GDP conditions according to Art. 84 and Art. 85b Para. 3 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (“Directive 2001/83/EC”), the contract partner must organize a correspondingly compliant transport or enable ROTOP to handle the shipment accordingly, for example by sending shipping material and shipping/packaging instructions. If no transport under GDP conditions according to Directive 2001/83/EC is required, ROTOP must be informed of this at the latest with the written order.

Any records of transport monitoring, such as transport temperature, of a transport under GDP conditions according to Directive 2001/83/EC must be made available to ROTOP immediately after receipt of the shipment by the contract partner. If these records are not made available, ROTOP is entitled to charge a processing surcharge of EUR 350.00.

13. ROTOP does not bear any costs for necessary export and import permits or other official authorizations. If ROTOP is obligated to assist the contract partner in obtaining these documents due to contractual agreement, this shall be at the contract partner’s expense.

14. In case of deliveries to countries outside the EU, further costs may be incurred which have to be borne by the contract partner. These include in particular costs for the transfer of funds by credit institutions, such as transfer and exchange rate fees, or import duties, such as taxes, customs duties and costs for import and export control.

15. Payments shall only be made by bank transfer or credit card; cash, bill of exchange and cheque payments shall not be recognized as fulfilment of the payment obligation. ROTOP charges a handling fee of 3.5% of the net value of the Order for payments by credit card.

16. For a delivery order of less than 10 packages (kits), ROTOP is entitled to charge a processing fee of EUR 180.00.

17. The contract partner must pay the remuneration owed by it immediately after delivery and receipt of an invoice for the delivery or service. After the unsuccessful expiry of this payment period, default occurs. In the event of default of payment, ROTOP shall charge interest on arrears at a rate of 9 percentage points above the respective base interest rate for the amount outstanding for payment. The assertion of further damages caused by delay remains unaffected. In addition, all existing claims shall become due for payment immediately.

ROTOP’s invoices include wage development or wage production costs and are not supplier invoices.
If the contract partner has not fulfilled his payment obligation even one month after the expiration of the payment period, ROTOP is entitled – without giving up further rights and claims – to withdraw from the existing contract.

18. The assertion of the contract partner’s rights for the delivery of goods with regard to defects requires that the contract partner inspects the goods after delivery and notifies ROTOP of any defects immediately. With regard to obvious defects or other defects that would have been detectable in an immediate, careful inspection, they shall be deemed to have been approved by the contract partner if ROTOP does not receive a written notice of defects within three (3) working days after delivery. With respect to hidden defects, the goods shall be deemed to have been approved by the contract partner if ROTOP does not receive a notice of defects within three (3) working days after the time the defect became apparent.

19. If the goods are defective, ROTOP shall be entitled to choose whether to remedy the defect free of charge for the contract partner or to deliver goods free of defects as a replacement. If the supplementary performance fails, the contract partner shall be entitled, at its option, to demand rescission or reduction. Properly delivered and defect-free goods will neither be taken back nor exchanged.

20. The limitation period for the assertion of warranty claims shall be 12 months from the date of delivery of the goods to the contract partner. The limitation period in the case of a delivery recourse according to §§ 478, 479, 445b BGB (German Civil Code) remains unaffected.

21. Unsolicited returns that are expired, outdated or spoiled will be destroyed by ROTOP. There is no claim to return these to the contract partner if, due to the general appearance or expiration of the expiry date, ROTOP may no longer take the responsibility for a return for quality reasons. The legal requirements for quality assurance for pharmaceuticals apply accordingly.

22. The delivered goods remain the property of ROTOP until all claims arising from the business relationship between ROTOP and the contract partner have been paid in full. The contract partner is entitled to resell the goods subject to retention of title in the normal course of business; however, the contract partner is not permitted to pledge or assign them as security. The contract partner hereby assigns to ROTOP all claims of the contract partner arising from the resale of the goods subject to retention of title. ROTOP accepts this assignment. Notwithstanding the assignment and ROTOP’s right to collect, the contract partner is entitled to collect as long as he meets his obligations to ROTOP and does not suffer financial collapse. In hits case, at the request of ROTOP, the contract partner shall provide ROTOP with the information necessary for collection regarding the assigned claims and shall inform the debtor of the assignment. If the realizable value of the securities exceeds the total claims of ROTOP to be secured by more than 10%, the contract partner is entitled to demand release to that extent.

In the event of seizures or other interventions by third parties, the contract partner must inform ROTOP thereof in writing without delay.

23. The contract partner shall only be entitled to set-off if his counterclaim is undisputed or has been finally adjudicated. The contract partner shall only be entitled to assert a right of retention if his counterclaim is based on the same contract and is undisputed or has been legally established.

24. Until all claims of ROTOP have been paid in full, the contract partner is obliged to treat the delivered goods with care and to insure it at his own expense against transport damage, fire and water damage and theft as well as other insurable risks. Upon ROTOP’s request, the contract partner shall submit proof of the existence of such insurance.

25. Serious events of force majeure, such as adverse weather conditions, adverse environmental events, labor disputes, riots, pandemics, war or terrorist attacks, operational disruptions, impediments to transportation, incorrect or untimely delivery by ROTOP’s suppliers, which have consequences for the performance of the contract that were not foreseeable at the time the contract was concluded, shall release ROTOP from its delivery and performance obligations for the duration of the disruption and to the extent of its effect, even if ROTOP is in default. The contracting parties are obliged to inform each other about the existence of such hindrances. In case of obstacles of temporary duration, the delivery or service dates shall be postponed by the period of the obstruction plus a reasonable start-up period. If the hindrances make delivery or performance by ROTOP substantially more difficult or impossible and the hindrance is not only of temporary duration, ROTOP is entitled to dissolve the contract.

26. The contract partner shall indemnify ROTOP from recourse claims of third parties for which the contract partner is responsible.

27. ROTOP shall not be liable for damages caused by improper handling or storage of the delivered goods by the carrier or the contract partner.

28. ROTOP shall be liable for any kind of breach of duty (pre- contractual, contractual and non-contractual) for damages or reimbursement of expenses only in case of gross negligence and intent on the part of ROTOP (or its vicarious agents). In the event of injury to life, body, health, or the violation of a contractual obligation that endangers the achievement of the purpose of the contract (essential contractual obligation), ROTOP shall, in deviation from this, also be liable for negligence. Liability under the German Product Liability Act or the German Medicines Act shall remain unaffected. If ROTOP is liable due to simple or gross negligence, its liability is limited to the foreseeable damage typical for the contract. The same shall apply in the event of a claim by the contract partner for damages instead of performance or for reimbursement of useless expenses. In all other respect’s liability is excluded.

This provision also applies with regard to possible personal liability of ROTOP’s employees, representatives and vicarious agents.

29. Contractual rights and obligations of the contract partner are not transferable to third parties.

30. All documents (e.g., illustrations, drawings, calculations or other documents) which ROTOP provides to the contract partner remain the property of ROTOP. The contract partner must treat the documents confidentially – even without explicit identification – and may not use them for purposes other than those stipulated in the contract, nor may he reproduce them, exploit them commercially, or – without the prior written consent of ROTOP – use them for or make them available to third parties. A right of retention is excluded. ROTOP reserves all industrial property rights to documents. The supplier shall only be entitled to a right of use free of charge within the scope of the performance of this contract.

31. The compliance with the national regulations relevant for the contract partner as well as the regulations of the country to which delivery is to be made according to the contract is the responsibility of the contract partner. This applies in particular to the relevant provisions of foreign trade law as well as to the approval regulations to be observed. The contract partner shall inform ROTOP in writing about any particularities of the contract execution resulting from these regulations at the time of contract conclusion. The contract partner confirms that he has the necessary permits for the distribution and import of pharmaceuticals (in particular wholesale permits, handling permits, licenses, import permits, license for storage of pharmaceuticals, foreign exchange transfer permits) and Directive 2001/83/EC and any subsequent amendments. The contract partner shall provide ROTOP with appropriate evidence in English or German upon conclusion of the contract.

Possible local registrations of products, applications for reimbursement of costs or similar are generally not owed by ROTOP and will only be made after prior written agreement.

32. Agreements in a delimitation of responsibility contract concluded or to be concluded with the contract partner shall apply in addition to these GTC and shall take precedence over them in the event of deviations.

33. All data created under the contractual relationship will be collected, stored and processed in accordance with the EU GDPR. Additional information on requirements under data protection law are included in Annex 1.

34. The place of performance for deliveries and payments is in 01328 Dresden, Bautzner Landstraße 400, Germany. The place of jurisdiction is Dresden, Germany. The law of the Federal Republic of Germany shall apply, to the exclusion of the UN Convention on Contracts for the International Sale of Goods (CISG).

35. Should a provision of the contract or of these GTC be invalid in whole or in part, this shall not affect the validity of the remaining provisions. Any such provision shall be replaced by a provision that comes as close as possible to the invalid provision.

36. In case of differences between the English and the German version of these GTC, the German version shall prevail.

Last revision of the text: July 2023