General Terms and Conditions

1. General Provisions

1.1 These General Terms and Conditions for the Sale of Goods (“GTC”) shall apply exclusively to contracts with entrepreneurs within the meaning of Section 14 of the German Civil Code (“BGB”), legal entities under public law and special funds under public law.
1.2 The subject matter of these GTC shall be all deliveries made by CytoSorbents Europe GmbH (“CytoSorbents”) to its purchaser of goods (“Customer”). The services pursuant to sentence 1 shall be provided exclusively under the terms and conditions of these GTC. Other provisions, in particular general terms and conditions of the Customer shall not apply, regardless of whether they have been expressly rejected by CytoSorbents or not. These GTC shall apply exclusively even if CytoSorbents performs or accepts a service without reservation in the knowledge of other terms and conditions.
1.3 These GTC shall also apply to future similar legal transactions between CytoSorbents and the Customer.
1.4 Individual agreements made between CytoSorbents and the Customer in individual cases shall have priority.

2. Conclusion of Contract
Offers made by CytoSorbents are generally non-binding.

3. Quality of the Goods, Specifications and Application, Warranties
3.1 The quality of the goods shall be exclusively the specification which is the subject of the individual contract. It is the Customer’s responsibility to verify whether the goods are suitable for the purposes requested by Customer.
3.2 Any statements made by CytoSorbents verbally, in writing or in any other form regarding the suitability, including application, processing and other use, shall be made to the best of CytoSorbents’ knowledge, but shall be deemed to be non-binding information only and shall not relieve Customer from its own examination of the goods delivered by CytoSorbents as to their suitability for the intended purposes. The customer is responsible for ensuring that medical devices are only used in accordance with the intended purpose as per product description.
3.3 Warranties, in particular warranties as to quality, shall be binding on CytoSorbents only to the extent that they (i) are contained in an offer or order confirmation, (ii) are expressly designated as a “warranty” or “warranty as to quality”, and (iii) expressly set forth the obligations of CytoSorbents resulting from such warranty.
3.4 CytoSorbents reserves the right to make technical changes for the purpose of product improvement or to comply with legal requirements, provided that such changes are not material or otherwise unreasonable for the Customer, taking into account the legitimate interests of both parties.

4. Transfer of Risk, Default of Acceptance
4.1 Deliveries shall be made EXW Incoterms 2010 from CytoSorbents Logistic Hub, Otto-Lilienthal-Strasse 6, 15566 Schöneiche bei Berlin, or from any other place designated by CytoSorbents.
4.2 The risk of accidental loss and accidental deterioration of the goods shall pass upon handover to the customer or to the transport person commissioned by the customer. The handover shall be deemed to have taken place if the Customer is in default of acceptance. If it has been agreed in an individual case that CytoSorbents shall be responsible for the shipment of the goods, the risk of accidental loss and accidental deterioration of the goods shall pass to the Customer upon delivery of the goods to the transport person.
4.3 CytoSorbents is entitled to make partial deliveries, provided that their acceptance is not unreasonable for the Customer, in particular if the delivery of the remaining ordered goods is ensured and the Customer does not incur any significant additional expenses or costs as a result (unless CytoSorbents agrees to bear such costs). Each partial delivery may be invoiced separately.
4.4 The Customer shall be in default of acceptance if it fails to collect the goods on the bindingly agreed delivery date. In case of non-binding delivery periods or dates CytoSorbents may notify Customer with a notice period of two weeks that the goods are ready for collection; if the Customer fails to collect the goods upon expiry of the notice period he shall be in default of acceptance.
4.5 If the Customer is in default of acceptance, fails to cooperate or if delivery by CytoSorbents is delayed for other reasons for which the Customer is responsible, CytoSorbents shall be entitled to claim compensation for the resulting damage and any additional expenses incurred (such as storage costs). Further claims shall remain unaffected.

5. Delivery Periods and Dates, Delay in Delivery
5.1 Delivery periods and dates shall be agreed individually in writing.
5.2 Delivery periods and dates shall not be binding unless they are expressly designated as “binding” in the individual contract. Subsequent amendments to the contract may lead to an extension of the agreed delivery periods and postponement of the delivery dates.
5.3 Delivery periods shall commence upon conclusion of the contract, unless expressly stipulated otherwise. Delivery periods shall not commence, however, before the Customer has fully complied with any existing obligations to cooperate and, if advance payment has been agreed, not before CytoSorbents has received the agreed payment.
5.4 CytoSorbents shall not be in default of delivery as long as a supplier fails to supply CytoSorbents correctly or in a timely manner for reasons beyond CytoSorbents’ control.
5.5 If the goods cannot be delivered in time and on schedule, CytoSorbents shall notify the Customer thereof without undue delay and at the same time inform the Customer of the expected new delivery period and the new delivery date. If the goods are permanently not available, CytoSorbents is entitled to withdraw from the contract. In this case CytoSorbents will refund to the Customer all payments, if any, already made by the Customer in relation to the order. The rights of the Customer in connection with a delay in delivery and the provisions of Clause 6 shall remain unaffected.
5.6 In the event of non-binding delivery periods or delivery dates, CytoSorbents shall not be in default prior to the fruitless expiration of a reasonable period for delivery set by the Customer in writing. The Customer may not fix the expiration of such period at a date earlier than two weeks after the expiration of the non-binding delivery period or delivery date.

6. Force Majeure
If CytoSorbents is unable to perform its contractual obligations due to force majeure such as mobilization, war, terrorism, riots, natural disasters, fire or other unforeseeable circumstances for which CytoSorbents is not responsible, e.g. strikes or lawful lockouts, operational or transport disruptions, difficulties in procuring raw materials, virus and other attacks by third parties on CytoSorbents’ IT system, insofar as these occurred despite the observance of due diligence customary for protective measures, as well as direct or indirect effects of epidemics or pandemics (including unforeseeable consequences of the COVID-19 pandemic), including related governmental, legal or other measures, the agreed delivery and performance periods as well as delivery and performance dates shall be extended in each case by the duration of the hindrance plus a reasonable start-up period, but by no more than three months. CytoSorbents shall not be responsible for the aforementioned circumstances even if they occur during an already existing delay. CytoSorbents shall notify the Customer of the beginning and the expected end of such circumstances as soon as possible. If the hindrance lasts six weeks or longer, both parties may withdraw from the contract.

7. Retention of Title
7.1 CytoSorbents retains title to the delivered goods until receipt of all payments resulting from the business relationship. If a current account relationship exists within the scope of the business relationship, CytoSorbents shall retain title to the delivered goods until receipt of all payments from recognized balances.
7.2 In the event of Customer’s breach of contract, in particular default of payment, CytoSorbents shall be entitled to withdraw from the contract and to take back the goods delivered under retention of title (“Retained Goods”) after unsuccessful expiration of a grace period. For the purpose of taking back the Retained Goods, CytoSorbents may enter the Customer’s business premises during normal business hours. If CytoSorbents takes back the reserved goods after unsuccessful expiration of a grace period, this shall constitute a rescission of the contract. Further claims of CytoSorbents shall remain unaffected.
7.3 After taking back the Retained Goods, CytoSorbents shall be entitled to make reasonable use thereof after having given prior warning; the proceeds of such use shall be set off against the Customer’s liabilities, less reasonable costs of such use.
7.4 The Customer shall not be entitled to sell, pledge, or assign by way of security the Retained Goods without the prior written consent of CytoSorbents. In the event of seizure, attachment, or other disposition of the Retained Goods by third parties, the Customer shall notify CytoSorbents immediately. To the extent that the third party is not able to reimburse CytoSorbents for the judicial and extrajudicial costs of an action pursuant to § 771 of the German Code of Civil Procedure (ZPO), the Customer shall be liable for the loss incurred by CytoSorbents.
7.5 Customer shall treat the Retained Goods with care. In particular, the Customer shall adequately insure the Retained Goods at replacement value against fire, water and theft.
7.6 The Customer shall take reasonable measures and provide CytoSorbents with comprehensive support in protecting CytoSorbents’ rights under this Section 3.4 in the country in which the Retained Goods are located (if necessary, by other means of security).

8. Defect Rights
8.1 The Customer’s rights in respect of defects shall be subject to the Customer inspecting the goods upon delivery and giving due notice of defects in accordance with § 377 of the German Commercial Code (HGB).
8.2 Notices of defect shall be made in writing, stating the specific defect. CytoSorbents shall be notified without undue delay in writing of any complaints due to incomplete delivery and other recognizable defects, stating contact details, product and, if applicable, batch number(s), as well as a description of the defect; hidden defects shall be notified without undue delay after their discovery. Acceptance of the goods may not be refused due to insignificant defects. Claims based on defects notified late shall be excluded. Obvious shipping damage must be reported to the shipping service provider upon receipt of the goods.
8.3 The costs of the inspection of the goods shall be borne by the Customer. Goods reported as defective shall be made available to CytoSorbents for inspection upon request.
8.4 In the event of a shortage in delivery, the Customer shall note the visible shortage on the shipping documents of the carrier and contact CytoSorbents Customer Service immediately, at the latest within five working days. Shortages that are not discovered until later must be reported immediately upon discovery. CytoSorbents will investigate the shortages and, in consultation with the Customer, make arrangements for a replacement delivery or issue an appropriate credit.
8.5 The statutory provisions shall apply to the Customer’s rights in the event of defects, unless otherwise provided below. The basis for the liability for defects shall be, above all, the agreement made on the quality of the goods in accordance with clause 3.1. Insofar as the quality has not been agreed upon, it shall be assessed according to the statutory provisions whether a defect exists or not.
8.6 In the event of defective goods CytoSorbents shall, at its own discretion, provide subsequent performance by remedying the defect (subsequent improvement) or by delivering a defect-free item (subsequent delivery). In the case of rectification, the remaining part of the original limitation period shall begin to run upon return of the rectified goods. The same shall apply in the case of subsequent delivery.
8.7 In case of subsequent delivery, the Customer shall return the defective goods to CytoSorbents in accordance with the statutory provisions.
8.8 If the Customer has installed the defective goods in another item or attached them to another item in accordance with their nature and intended use, CytoSorbents shall reimburse the Customer for the necessary expenses incurred for the removal of the defective goods and the installation or attachment of the repaired or delivered non-defective goods within the scope of subsequent performance in accordance with the statutory provisions. Unless otherwise agreed, CytoSorbents shall not be obliged to remove the defective goods and to install or affix the repaired or delivered non-defective goods within the scope of supplementary performance. This shall not apply if CytoSorbents was originally contractually obligated to install or attach the ordered goods.
8.9 If the subsequent performance fails, the Customer may withdraw from the contract.
8.10 If there is no defect, CytoSorbents shall be entitled to demand reimbursement from the Customer of the costs incurred as a result of the unjustified request to remedy the defect (in particular inspection and transport costs) if the Customer was aware or could have been aware of the non-existence of the defect.
8.11 The limitation period for defect rights shall be one year from delivery. However, this limitation shall not apply if (i) a defect has been fraudulently concealed or (ii) a guarantee for the quality of the goods has been assumed (in this respect, the guarantee provision or limitation period resulting from the guarantee shall apply, if applicable). In the event of claims for damages, this limitation shall furthermore not apply in the following cases: (i) injury to life, body, or health, (ii) intent and (iii) gross negligence of organs or executive employees of CytoSorbents as well as (iv) liability according to the Product Liability Act and (v) recourse claims according to § 478 para. 2 BGB.

9. Compliance with Regulations and Export
9.1 The Customer shall comply with all statutory provisions and official and regulatory requirements (e.g. with regard to the traceability of the goods) as well as all other applicable laws and, in particular, export regulations and the laws of the country in which the Customer does business. The Customer shall timely obtain all necessary permits and licenses and any other necessary permissions required for the use or export of the goods under all such applicable laws.
9.2 CytoSorbents shall have the right to withhold delivery from the Customer if delivery to the Customer would violate any such applicable laws or if all required permits are not in place and this is not due to the fault or responsibility of CytoSorbents.

10. Prices, Price Adjustment, Payment, Default in Payment
10.1 The respective prices for goods shall be determined according to the individual contract or, in the absence of a contractual provision, according to the respective valid price list. Prices shall be EXW Incoterms 2010 of CytoSorbents, Müggelseedamm 131, 12587 Berlin, in Euro. Any applicable value added tax shall be charged separately at the applicable statutory rate and shall be paid by Customer.
10.2 Invoices shall generally be paid in advance or, with CytoSorbents’ prior consent, within 30 days after delivery and receipt of the invoice without deduction. Unless otherwise agreed, payments shall be made in Euro.
10.3 The Customer’s payment may be made cashless with effect of performance exclusively to the account specified by CytoSorbents in the contract or the respective invoice. In any case, all payments shall be made free of charge to CytoSorbents.
10.4 If the payment deadline is exceeded, the Customer shall be in default without further reminder. The receipt of the invoice amount on the specified account shall be decisive for the timeliness of payment.
10.5 During the period of default, the customer shall pay interest on arrears in the amount determined by law. We reserve the right to claim further damages.
10.6 If Customer defaults on at least two payments arising from the business relationship with CytoSorbents, all payment obligations of Customer arising from all business relationships with CytoSorbents shall become due immediately.

11. Confidentiality
11.1 The Customer undertakes to treat all information provided by CytoSorbents under the individual contract as confidential and not to disclose such information to any third party.
11.2 The information shall in particular include all information in written, including photocopied, form as well as drafts, sketches, technical protocols, models, electronic data, irrespective of the form in which this information is provided (e.g. through conversations, long-distance calls, on data carriers of any kind, by means of remote data transmission of any kind or by mail). Also covered is all information and know-how that is perceived visually and/or acoustically. Confidential information includes in particular all technical data, prices, information on developments relating to the goods and services, on research and development projects, all company data.
11.3 The confidentiality obligation shall not apply to information which is generally known and has been lawfully obtained from third parties.
11.4 If the Customer becomes aware that confidential information has been unlawfully disclosed to third parties, the Customer shall notify CytoSorbents thereof without undue delay.

12. Liability
12.1 The liability of CytoSorbents for damages caused by ordinary negligence shall be limited to damages resulting from the breach of essential contractual obligations, the fulfillment of which is a prerequisite for the proper performance of the contract and on the observance of which the contractual partner regularly relies on and may rely; in this case, however, liability shall be limited to the typical foreseeable damage. This limitation of liability shall apply in the same manner to damages caused by gross negligence on the part of employees or agents of CytoSorbents who are not officers or executives of CytoSorbents.
12.2 The above limitations of liability shall apply to all claims for damages, irrespective of the legal grounds, with the exception of claims for damages of the Buyer (i) due to fraudulently concealed defects, (ii) due to defects with regard to which a guarantee for the quality of a good has been assumed (in this respect, if applicable, the guarantee provision or limitation period resulting from the guarantee shall apply). (iii) under the German Product Liability Act, (iv) for injury to life, body or health, (v) for willful misconduct or (vi) for gross negligence on the part of CytoSorbents’ officers or directors.
12.3 The above limitations of liability shall also apply to Customer’s claims for damages against CytoSorbents’ officers, directors, employees or agents.

13. Final Provisions
13.1 The Customer may only set off or exercise a right of retention against claims of CytoSorbents if the Customer’s counterclaim is undisputed, a legally binding title exists, or the counterclaim is based on the same contractual relationship.
13.2 The Customer may not transfer the rights and obligations incumbent upon it in connection with Deliveries in whole or in part to third parties without the prior written consent of CytoSorbents.
13.3 All legal relations between CytoSorbents and the Customer shall be governed by German law to the exclusion of the UN Convention on Contracts for the International Sale of Goods (CISG).
13.4 Unless otherwise provided, the place of performance shall be the registered office of CytoSorbents.
13.5 The exclusive place of jurisdiction for all disputes arising from or in connection with a delivery shall be the district court at the registered office of CytoSorbents. However, CytoSorbents shall also be entitled to sue the Customer at the Customer’s place of business.