General Terms and Conditions

1. SCOPE

These General Terms and Conditions of OncoBeta® GmbH (OBG) apply to any offer proposed by OBG and are deemed accepted by OBG’s contract partner (Customer) wherever Customer’s principal place of business may be located (only subject to any national statutory law that may apply and overrule any provision hereof in any country where OBG’s product, device or component (collectively, Product) may be used, against payment received by OBG, specifically including, but not limited to, Europe, South Africa, Brazil, Australia, Canada and the United States of America), at the earliest upon being made available to Customer, and, at the latest, upon delivery of the Product to Customer; provided, however, any written agreement individually negotiated and entered into shall, to the extent in conflict with these provisions, supersede and exclusively govern the following.

2. OFFER AND ACCEPTANCE

Any offer proposed by OBG is binding for 30 days after submittal to Customer; provided, however, any offer proposed by OBG, and the acceptance by OBG of an order by Customer, is valid and binding on OBG only if any equipment related to the Product and/or the environment at Customer’s site are approved by OBG, and if the required authorization to work with the radioisotopes provided by OBG has been received by Customer from the national authorities, at the radioactivity levels of any Product. OBG will ensure compatibility before OBG’s acceptance of Customer’s order. If compatibility is not approved by OBG, any offer and/or acceptance by OBG is invalid and not binding on OBG and Customer may not assert any rights from the offer proposed or any acceptance by OBG. Orders of any disposable carpoule containing a rhenium-188 compound (REC) must be received by OBG at least 14 days prior to the delivery date, and OBG’s order form must be used.

3. PRICE

OBG’s price proposed shall be binding for 60 days, as specifically mentioned in the offer, or set forth in the pricelist of OBG valid at the time of acceptance by OBG of Customer’s order, and prices apply to delivery to Customer Ex Works OBG’s facility (EXW Incoterms® 2020), such facility either being OBG’s manufacturing site located in Garching near Munich, Germany, or at such other site as OBG may choose. Insurance, freight, VAT, taxes and/or any other fees or charges are not included in the price and charged separately.

4. DATE OF DELIVERY

OBG will deliver the Product, either as confirmed or within 112 days of the confirmed delivery date, except for REC, which will be delivered on the confirmed delivery date, subject to any technical requirements applicable thereto.

5. DELAYS

Delays in the delivery of Products, or in the performance of services, due to force majeure shall entitle OBG to either postpone the delivery or performance for the duration thereof, plus an appropriate restart-up period, or to cancel the then-unfulfilled part, in part or in full. OBG may delay REC deliveries by up to 2 days. Any REC orders cancelled within 3 business days before the designated delivery date will be fully paid by Customer. If the events delaying delivery continue for more than 3 months, Customer may cancel the then-unfulfilled part of the order. Timelines set for delivery may either be observed if all documents required by Customer, including permits, releases, plans, drawings or other documents or information, are received in time and no changes to the order occur after its confirmation, or be reasonably extended. If shipment is delayed due to Customer, all additional cost arising therefrom will separately be charged.

6. PAYMENTS

Payments must be made by wire transfer. Payments of order volumes above 15.000 Euros shall be net and due in half after placement of the order with OBG, and the other half within 14 days of delivery, and below such order volume, before shipment is made. Payment of REC orders shall be due net 14 days after delivery. Upon delayed or non-payment, OBG may charge Customer, as liquidated damages, interest per month (pro-rated per day) of 2% of the amount due. Customer may only set-off claims if under an agreed settlement, confirmed by a court of competent jurisdiction, or specifically accepted by OBG.

7. TRANSFER OF RISK

For and in the name of Customer, OBG may choose the appropriate carrier for the transportation of Product and may insure the Product, at Customer’s expense, against risk of loss or damage, including during transportation. The risk of loss of or damage to the Product shall pass to Customer Ex Works (EXW Incoterms® 2020) or, upon delay due to Customer, upon OBG’s readiness for shipment of Product.

8. INSTALLATION

Installation of Products other than REC will be performed by an OBG engineer within 20 business days of delivery. Installation will generally require not more than 1 visit by an OBG engineer. If more visits are required, OBG will notify Customer in advance. Customer shall pay, against OBG’s invoice, any cost if more than scheduled visits for installation are required, or if installation completion is delayed for more than 60 business days after delivery, because of circumstances due to Customer, including, but not limited to, false or incomplete technical information, or inappropriate equipment or premises.

9. ACCEPTANCE PROTOCOL

After completed installation and prior to final acceptance, an OBG engineer will perform testing to ensure functioning in accordance with the then-applicable specifications. At least one representative of Customer shall be present during such testing. After successful testing, Customer shall accept the Product and sign OBG’s acceptance protocol, deemed an integral part hereof or separate agreement. Acceptance shall not be declined based on minor issues that do not affect the suitability for safe clinical use. Product may not be used prior to performance of testing and the acceptance protocol being signed and mutually executed by OBG and Customer and, if used before such mutual execution of the acceptance protocol, that Product shall be deemed accepted.

10. OBG TRANSPORT CONTAINERS

Customer will keep in good condition any transport container of OBG, and not use it for any other materials and pick-up from the clinic or other place of use, and return it to OBG, with transportation costs to be borne by Customer, within 14 days of the date of agreed use, and upon any delay of return, Customer will pay 55 Euros for each business day thereafter. Transport instructions will be provided by OBG. Customer may either itself coordinate the return or OBG will coordinate on behalf of Customer. If Customer returns any damaged and/or contaminated transport container, OBG shall repair and/or decontaminate it and invoice Customer for the cost of repair and/or decontamination.

11. WARRANTY

For all parts of the Products supplied by OBG (excluding REC), the warranty granted to Customer by OBG shall be 12 months, beginning, whichever is first, (i) 3 months after delivery; (ii) 1 month after installation; (iii) Customer’s acceptance of the Oroduct; (iv) treatment of the first patient. OBG will, in its sole discretion, repair or replace defective Products. If OBG fails to do so within reasonable time, Customer may demand an appropriate reduction of the sales price. The quality of the Product must exclusively be determined in accordance with the then-applicable specifications, which shall exclusively govern. The specifications are subject to change without notice to the extent not being material and not negatively affecting the suitability for the use intended by Customer. Any warranty is excluded with respect to general wear and tear, malfunctions caused by abuse, misuse, force majeure, accident, or the like. No warranty is given regarding fitness for a particular purpose or commercial practice, unless agreed otherwise in writing. In-warranty repair or replacement parts are warranted for the unexpired portion of the initial warranty period. Customer’s claims are only valid when made in writing. Customer will quarantine, or return to OBG, Product or parts thereof for warranty inspection, all promptly upon OBG’s request.

12. INSPECTION AND DEFECT NOTICES

For all Products other than REC, Customer shall examine the Product upon delivery and notify OBG of any damage. During the acceptance test, Customer shall inspect the Product in the presence of an OBG engineer. Any defect or missing part shall be listed in the acceptance protocol. OBG will not accept complaints relating to defects (including malfunctions or missing items) that have not been reported in the acceptance protocol, except for latent defect of which Customer notified OBG in writing within 12 months of delivery; provided, however, Customer will notify OBG within 8 days after discovery thereof or, if otherwise, the Product shall be deemed accepted.

13. INFORMATION OF ADVERSE EVENTS AND HAZARDOUS SITUATIONS

Customer must inform OBG, immediately or otherwise without undue delay, if a Product is subject to malfunction or if a patient, user or other third party suffers, or could suffer, any harm caused thereby.

14. LIMITATIONS OF LIABILITY

OBG shall not be liable for any damage caused by use of the Product before successful completion of the acceptance test. OBG shall only be liable to Customer for damages or material breach of material duty of OBG caused by OBG’s willful misconduct and, to the utmost extent permissible by applicable statutory law, (i) OBG’s liability for any type of negligence shall be limited to the foreseeable damage, including with respect to any and all (including tort) claims of Customer against OBG; (ii) with respect to any strict (product) liability of OBG related to Customer’s use of the Product, Customer shall indemnify OBG for any amount above such foreseeable damage, including for suffering bodily injury, compromised health, or death.

15. RETENTION OF TITLE

OBG shall retain title to the Product until payment is made in full. Should any third party take steps to levy execution upon or otherwise dispose of the Product, Customer shall immediately notify OBG in due time or otherwise, Customer will be liable for any damages caused.

16. INDUSTRIAL PROPERTY RIGHTS

All rights to patents, trademarks, and any other intellectual property shall remain the property of OBG.

17. CONFIDENTIALITY

Customer shall keep in confidence all information, including, but not limited to, technical data, product descriptions, and any other information which is readily and reasonably identifiable as confidential based on its nature and/or the circumstances of its disclosure. For clarity, the foregoing shall include information provided orally. Such information shall not be disclosed to any third parties or employees, except for employees who are directly involved in the operation of the purchased equipment.

18. DATA STORAGE

All Customers’ related information will be stored electronically on OBG’s computer systems.

19. SEVERABILITY, GOVERNING LAW

The effectiveness, validity or applicability of the other provisions hereof shall not be affected if any provision hereof should be deemed non-applicable, void or invalid and, subject to mandatory statutory law, such provision (or any gap hereunder unintentionally not considered) shall be replaced by a provision closest to the commercial intent of OBG and Customer as shown hereby. The United Nations Convention on Contracts for the International Sale of Goods shall have no application and shall be of no force and effect with respect to the matters herein set forth or contemplated. All legal relations between OBG and Customer shall be construed, interpreted, and enforced in accordance with and governed by the laws of Germany, regardless of the laws which might govern under any conflict-of-law principles, and the competent courts of Munich, Germany, shall have exclusive jurisdiction.