General terms and conditions of sale, delivery and payment

Last updated: February 2023

1. General

1.1. These General Terms and Conditions of Sales and Delivery (the “Conditions”) shall apply to all sales of products and service transactions (the “Products”) between PentaBase A/S (“PentaBase”) and Buyer.

1.2. Special Terms and Conditions of Sales and Delivery, which apply for Research Use Only (“RUO”) Devices, are described in section 7.4.

1.3. Special Terms and Conditions of Sales and Delivery apply for in vitro (CE IVD) devices; see section 7.5.

1.4. The Conditions shall remain in force in cases where they are not specifically enclosed or attached but have been brought to the Buyer’s attention, for example (but not limited to) in connection with Order Confirmation or Invoicing of the Buyer.

1.5. Offers are binding to PentaBase only upon order confirmation. Offers found in price lists, brochures, the internet, etc., may only be used as guidance and non-binding to PentaBase.

1.6. Different conditions or reservations of the Buyer are binding only if expressly acknowledged in writing by PentaBase. In the event of a conflict between contractual provisions agreed in writing and these Conditions, the contractual provisions shall prevail.

2. Execution of Contract

2.1. A contract for the sale and purchase of the Products shall be valid upon written acknowledgment by PentaBase (“Order Confirmation”) and/or upon issuing an invoice to Buyer.

2.2. Deviations from the order in the Order Confirmation or invoice shall become an integral part of the contract for the sale and purchase of the Products unless disputed in writing by the Buyer within three (3) business days of receipt of the Order Confirmation or invoice. PentaBase reserves the right to correct simple invoicing errors.

3. Scope and Pricing of Products Supplied

3.1. Sales are at the quantities and prices set out in the contract for the sale and purchase of the Products.

4. Terms of Delivery

4.1. Orders are delivered FCA (Free Carrier), Incoterms 2020, Petersmindevej 1A, 5000 Odense C, Denmark, unless otherwise agreed in accordance with 2.2 above and shall occur by the date set out in the Order Confirmation.

4.2. Deviations from the above term of delivery must be expressly stated in PentaBase’s Order Confirmation or invoice.

4.3. If PentaBase is unable to deliver on time, or at all, due to events beyond its control (force majeure) occurring at PentaBase or its suppliers, PentaBase shall have the right to withdraw from the contract for the sale and purchase of the Products in whole or in part. Specifically, PentaBase reserves the right to effect partial deliveries.

5. Passage of Risk and Title

5.1. Title and risk shall pass to Buyer upon the earlier of:1) disposal of the goods at the agreed place of disposal or delivery; or 2) the designated delivery date if disposal or delivery failed to occur due to circumstances of the Buyer.

5.2. Notwithstanding delivery, the ownership of the Products remains vested in PentaBase until receipt of the Buyer’s full payment. In case of lack of payment, in whole or in part, or if PentaBase reasonably may anticipate Buyer’s inability to make timely payment: 1) Buyer shall, at its risk and expense, return the Products upon demand of PentaBase; or 2) if 1) does not occur within a reasonable time or is otherwise impracticable, PentaBase may, at Buyer’s full risk and expense, use any means to resell the Products or to recover them or any sum outstanding. These rights are without prejudice to PentaBase’s s other rights herein, at law and otherwise.

6. Inspection and Acceptance of Shipments

6.1. Buyer shall immediately, upon receipt, carry out a thorough inspection of the delivered Products and shall notify PentaBase without delay and in any event within five (5) working days from receiving the order if any of the Products does not visibly conform with the specifications of the Products and to these Conditions, including but not limited to damages due to temperature. Buyer shall notify PentaBase of any other quality-related issues immediately and within 30 (thirty) days from the date of receipt. PentaBase disclaims any liability, and Buyer waives all rights of recovery if Buyer fails to make a valid claim as described above or fails to make such a claim for defects or problems it reasonably should have detected.

7. Use of the Products

7.1. The Products shall only be used following instructions for use provided by PentaBase.

7.2. Buyer shall, in any resale or other distribution of the Products, ensure that all relevant information accompanies them, including but not limited to safety information. If Buyer fails to do so, Buyer shall hold harmless and indemnify PentaBase for any claim against PentaBase.

7.3. Unless otherwise agreed, delivered Products and packaging cannot be returned to PentaBase.

7.4. Products labeled “Research Use Only” may

• Only be used for research purposes.
• Not be used as part of an in vitro diagnostics kit
• Not be used for in vitro diagnostics or other clinical use

7.5. CE IVD labeled medical devices intended for in vitro diagnostic in compliance with EU Directive 98/79/EC. Product or parts of Product may not be resold or transferred without PentaBase’s written acceptance.

7.5.1. The distributor should comply with article 14 of REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU if state within EU.

7.5.2. The distributor should comply with applicable national IVD legislation if stated outside the EU.

8. Records

8.1. Buyer shall maintain records for the Products as required by law, custom, and practice, such that PentaBase may easily track and recall the Products at any time.

8.2. These records should be available ten years after the last device has been distributed to the market upon request from PentaBase. Alternatively, can the information be transferred to PentaBase.

9. Recall of Products

9.1. PentaBase may recall the Products at any time upon notification (e.g., Field Safety Notice (FSN) or a manufacturer incident report (MIR)). The party whose error or omission caused the recall shall bear all reasonable costs. If PentaBase caused the recall, it shall, at its discretion, provide replacement of the Products or refund the purchase price. This section comprises Buyer’s exclusive, aggregate remedies involving recall.

9.2. The Buyer may recall the products using a MIR.

9.3. The Buyer shall provide support in translating and distributing the FSN to the relevant end-users.

9.4. Buyer shall obtain all licenses and exchange control and other official approvals necessary for the import, distribution, and usage of the Products; failure to do so shall not discharge Buyer of any duties herein.

10. Terms of Payment

10.1. Buyer shall, at its expense, make full payment in the invoiced currency within 30 (thirty) days of the invoice date.

10.2. PentaBase’s duty of sales and delivery herein is expressly conditioned on Buyer’s full performance of its duties of timely payment under these Conditions.

10.3. Buyer shall have no pledge or lien on the property of PENTABASE.

10.4. The buyer shall always pay in accordance with the specifications on the invoice

11. Limited Warranty and Limitation of Liability

11.1. PentaBase warrants that the Products are manufactured according to general industry standards and PentaBase’s written specifications, including but not limited to specifications describing the Products and instructions for the Products’ use (the “Warranty”). In case of defects or other non-conformity, PentaBase may, at its discretion, either replace the defective or non-conforming Products or reimburse Buyer for an amount equalling the purchase price paid for the defective or non-conforming Products in question.

11.2. This Warranty is the sole warranty provided as regards the Products, replacing and superseding all other warranties, whether expressed or implied by law, trade, custom, or otherwise, and the remedies described herein are the exclusive remedies of Buyer in case of defects or non-conformities.

11.3. Recovery under the Warranty is subject to Buyer proving actual loss, PentaBase’s breach of the Warranty, and demonstrating that Buyer stored, transported, handled, and used the Products in accordance with all PentaBase specifications and other written and oral instructions, as well as with all relevant laws, rules, and guidelines and with general industry standards.

11.4. To the extent permitted by law, PentaBase shall, regardless of cause, have no liability for damage to Buyer’s or a third party’s property or losses.

11.5. Notwithstanding the above, PentaBase shall have no liability for any hazardous situations arising from or related to risks caused by the Products but generally deemed as reasonably acceptable under the relevant circumstances, whether or not a risk was known or foreseeable and including but not limited to risks warned of in PentaBase’s written information. Buyer waives all such claims

11.6. PentaBase shall in no event, regardless of cause, be liable for any indirect, special, punitive, or consequential losses or damages, including but not limited to loss of profit, loss of business, and legal costs or fees, regardless of whether Buyer or a third party suffers such losses or damages. For the avoidance of doubt, this limitation of liability shall apply regardless of the basis on which such losses or damages are based, including but not limited to delay, defects, product liability, professional liability, contract, warranty, and tort.

11.7. In respect of all third-party claims, including but not limited to negligence, death, or personal injury, Buyer shall, to the extent permitted by law, hold harmless and indemnify PentaBase fully against any claims, costs, and fees exceeding PentaBase’s relevant limits of liability expressed elsewhere herein.

12. Law and Jurisdiction

12.1. As permitted by law, PentaBase and Buyer waive all international trade provisions, even as enacted into law.

12.2. These Conditions shall be governed and construed in accordance with the laws of Denmark, except for any provisions on choice of law.

12.3. Any dispute, controversy, or claim arising out of or in connection with these Conditions, including any questions regarding their existence, validity, or termination, shall be referred to and finally resolved by arbitration under the “Rules of Procedure of the Danish Institute of Arbitration” (“Danish Arbitration”), which rules are deemed to be incorporated by reference into this section 12. The language used in the arbitral proceedings shall be English, but the parties shall be entitled to produce documents without translation in English and Danish. The arbitral tribunal shall be composed of three (3) arbitrators appointed by the Danish Institute of Arbitration.

12.4. Notwithstanding the above, Buyer shall, on request from PentaBase, assist or become formally involved as a party, as the case may require, in any dispute between a third party and PentaBase, no matter the jurisdiction, the venue, and the language for such dispute.