Terms and Conditions – USA

Terms and Conditions of Sale in the United States
Technegas® Consumables – including equipment placement terms

These Terms and Conditions of Sale (“Terms”) govern all invoices issued by Cyclomedica USA LLC, a Delaware limited liability company (“Cyclomedica”), for the supply of TECHNEGAS® Consumables (“Consumables”) to the purchasing entity (“Customer”). To facilitate Customer’s use of the Consumables, Cyclomedica places the Technegas Plus System (“Equipment”) at Customer’s premises under a limited licence, the terms of which are set out below. By placing an order for or accepting delivery of Consumables, Customer agrees to be bound by these Terms. These Terms are governed by the laws of the State of Delaware, United States of America, without regard to conflicts of law principles.

1. CONSUMABLES — SALE AND USE

1.1 Cyclomedica sells Consumables to Customer solely for use with the Equipment to generate TECHNEGAS®, the FDA-registered radiopharmaceutical (kit for the preparation of technetium Tc 99m labeled carbon inhalation aerosol, NDA 022335), for pulmonary ventilation imaging at Customer’s facility.

1.2 The Equipment and Consumables together constitute the FDA-approved combination product authorized under NDA 022335. Because FDA approval extends only to the use of Cyclomedica’s proprietary Consumables with the Equipment, the introduction of any third-party, non-approved, or substitute materials would result in off-label use and may cause the resulting drug product to be deemed adulterated or misbranded under 21 U.S.C. §§ 351–352.

1.3 All Consumables sales are final and non-refundable. Title to Consumables passes to Customer on delivery.

2. EQUIPMENT PLACEMENT — TITLE AND OWNERSHIP

2.1 Cyclomedica places the Equipment at Customer’s premises solely to enable Customer to use the Consumables purchased hereunder. The Equipment is and shall at all times remain the sole and exclusive personal property of Cyclomedica. Placement of the Equipment does not constitute a sale, lease, transfer of title, or any other conveyance of ownership rights in the Equipment.

2.2 Customer acquires only a limited, revocable, non-transferable license to possess and use the Equipment solely for the purpose of generating TECHNEGAS® from Cyclomedica Consumables at the agreed facility location (“Location”). All rights not expressly granted remain with Cyclomedica.

2.3 Customer shall keep the Equipment free from all liens, claims, encumbrances, and legal process, and shall immediately notify Cyclomedica of any proceeding affecting the Equipment. The Equipment shall remain personal property of Cyclomedica regardless of how or how long it is installed.

2.4 Customer shall not sell, assign, transfer, sublicense, encumber, relocate, or otherwise deal with the Equipment without the prior written consent of Cyclomedica. Any unauthorized dealing is void and of no effect.

3. CONTINUITY OF COMMERCIAL RELATIONSHIP — CONDITION OF EQUIPMENT LICENCE

3.1 Because Cyclomedica places the Equipment at Customer’s premises at its own cost and retains ownership of the Equipment, the Equipment license is granted on the basis that Customer intends to use the Equipment to generate TECHNEGAS® from Cyclomedica Consumables on an ongoing clinical basis. The Equipment is not placed as a standalone benefit independent of that clinical use.

3.2 If Customer does not place any order for Consumables for a continuous period of one hundred fifty (150) days, Cyclomedica may issue a written notice of non-use to Customer. Customer shall then have thirty (30) days from receipt of such notice to either (a) place a Consumables order reflecting bona fide clinical use, or (b) confirm in writing that the Equipment is no longer required, in which case the parties shall cooperate to arrange collection of the Equipment in accordance with Section

3.3. The Equipment license shall lapse only upon expiry of that 30-day cure period without action by Customer. Nothing in this Section restricts Customer’s clinicians from using FDA-approved alternative radiopharmaceuticals or imaging modalities where clinically indicated.

3.3 Upon lapse or revocation of the Equipment license for any reason, Customer shall promptly make the Equipment available for collection by Cyclomedica, in the same condition as placed (ordinary wear and tear excepted), within ten (10) business days of notice or lapse. Cyclomedica shall bear the cost of collection and removal. Failure to make the Equipment available within this period entitles Cyclomedica to seek immediate legal relief, including injunctive relief, to compel return of its property.

3.4 Customer’s obligation to facilitate return of the Equipment survives termination or lapse of the Equipment license and is independent of any payment dispute.

4. AUTHORISED SERVICE AND MAINTENANCE

4.1 Because the Equipment remains the property of Cyclomedica and because Cyclomedica is subject to FDA quality system regulations (21 CFR Part 820) as the manufacturer of the Equipment used to generate the NDA 022335 drug product, all maintenance, servicing, calibration, repair, and adjustment of the Equipment shall be performed exclusively by Cyclomedica-authorized technicians. Customer shall not permit any other individual, contractor, or third party to perform any service or technical work on the Equipment without Cyclomedica’s prior written consent.

4.2 Customer shall not tamper with, modify, alter, reverse engineer, or attempt to repair the Equipment. Cyclomedica shall have no liability under any warranty or service obligation for any damage, malfunction, or non-conformity to the extent caused by unauthorized modification, tampering, or service by Customer or any third party. Unauthorized modification or service also constitutes a material breach of these Terms and may, following written notice and a reasonable opportunity to cure where practicable, result in revocation of the Equipment licence.

4.3 Customer shall permit Cyclomedica and its authorised representatives reasonable access to the Location during business hours for the purpose of inspection, servicing, audit, or retrieval of the Equipment.

5. BREACH AND CONSEQUENCES

5.1 The following constitute material breaches of these Terms, each entitling Cyclomedica to immediately revoke the Equipment license and demand return of the Equipment: (a) use of non-Cyclomedica consumables or materials with the Equipment in contravention of the FDA-approved indications for use described in Section 1.2; (b) unauthorized transfer, relocation, or encumbrance of the Equipment; (c) unauthorized modification or servicing of the Equipment; (d) cessation of Consumables purchases in accordance with Section 3.2; or (e) failure to return the Equipment within the period specified in Section 3.3.

5.2 Customer assumes full liability for any clinical, regulatory, or legal consequences arising from the use of non-approved consumables or materials with the Equipment.

5.3 Customer’s payment obligations for Consumables already invoiced are not affected by any breach or dispute regarding the Equipment.

6. GENERAL

6.1 Governing Law and Jurisdiction. These Terms are governed by and construed in accordance with the laws of the State of Delaware, United States of America. The parties consent to the exclusive jurisdiction of the courts of the State of Delaware and the United States District Court for the District of Delaware for the resolution of any dispute arising under these Terms.

6.2 Entire Terms. These Terms constitute the complete terms governing each Consumables invoice. If a separately executed written agreement between the parties addresses the same subject matter, that agreement shall prevail to the extent of any inconsistency.

6.3 Severability. If any provision is held invalid or unenforceable, the remaining provisions continue in full force and effect.

6.4 Non-Waiver. Cyclomedica’s failure to enforce any provision shall not constitute a waiver of its right to enforce that or any other provision in the future.

6.5 Equipment Financing Statement. Cyclomedica may file a UCC financing statement or equivalent notice with applicable authorities to protect its ownership interest in the Equipment. Customer consents to such filing.

Version Date: 19 June 2026

CYCLOMEDICA USA LLC
5126 South Royal Atlanta Drive
Tucker, GA 30084
[email protected]