END USER CERTIFICATE
Ref. Order #: — Date:
I, , the of (“End User”), hereby certify and agree to the following:
1. Equipment. The End User has ordered the following equipment (“Equipment”) manufactured by Sonablate Corp. and its subsidiary (“Company”) from ATKT.no - Kommersielle Tjenester og Konsulenttjenester (“Distributor”). Hereinafter “System” shall mean a complete HIFU system.
| Equipment Description |
# of Units |
2. Approval. The End User is authorized to purchase and use the Equipment pursuant to the following approvals of the applicable local authorities (a copy of each is attached):
| Authority |
Approval/Registration Number |
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3. Restriction on Resale. The End User acknowledges that Sonablate Corp., a Delaware corporation (the “Company”), has an interest in assuring that the Equipment is only sold to authorized users in locations where the Equipment is permitted for use. Therefore, End User agrees not to resell the Equipment to any person, entity, institution, or government, excluding Company or its affiliates and subsidiaries, outside of the following territory:
4. Physicians. The End User acknowledges that in conjunction with the purchase of a System, it will coordinate the training of any physician that will be utilizing the System with Distributor. Each physician that completes the required training shall be a “Trained Physician”. The End User will only permit properly licensed and credentialed Trained Physicians to use a System to perform procedures, in compliance with all applicable laws, regulations and local authorizations, and in accordance with the User Manual and all related documentation provided by Company or Distributor.
5. Maintenance. The End User will keep the Equipment in good working order and comply with the User Manual and all other documentation related to the Equipment provided by Company or Distributor.
6. Warranty. The End User acknowledges that the following limited warranty (“Limited Warranty”) is the only warranty provided by Company and Distributor in relation to the Equipment and that Company does not have any warranty obligations to End User except those explicitly stated in the Limited Warranty:
Limited Equipment Warranty. Company and Distributor agree to provide each End User in the Territory the following limited warranty for the Equipment (“Limited Warranty”): All Equipment is warrantied to be free from defects in material or workmanship under normal use and service for until the earlier of Thirteen (13) months after the date Equipment is delivered to the End User or Twelve (12) months after the date Equipment is initially installed (“Warranty Period”).
In the event any Equipment fails to comply with this Limited Warranty during the Warranty Period, Distributor shall provide, at Distributor’s expense, the services required under the Limited Warranty. If, however, Equipment requires services during the Warranty Period that go beyond the training provided by Company to Distributor’s Trained Engineers pursuant to the Distribution Agreement, Company or Company’s designee shall provide the required services pursuant to the Limited Warranty. During the Warranty Period, Company shall provide, at Company’s expense, any replacement parts required under the Limited Warranty. If Company determines that either the Limited Warranty was not breached, or the damage to the parts needing replacement was caused by negligence, recklessness or willful misconduct of the Distributor or End User or their agents, employees or third parties, the Distributor or End User of the Equipment shall be liable for any expenses incurred by Company related to the replacement parts and any provided services.
THIS CONSTITUTES THE SOLE WARRANTY MADE BY COMPANY. THERE ARE NO OTHER WARRANTIES EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGMENT. IN NO EVENT SHALL COMPANY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY TYPE (INCLUDING, WITHOUT LIMITATION, INTERRUPTION OF SERVICE, LOSS OF DATA, LOSS OF REVENUE OR PROFIT, OR LOSS OF TIME OR BUSINESS), EVEN IF ADVISED OF THE POSSIBILITY OR CERTAINTY OF SUCH DAMAGES, AND END USER’S REMEDIES SHALL BE LIMITED TO REPLACEMENT OF NONCONFORMING EQUIPMENT OR PARTS.
Misuse of Equipment. Any tampering, misuse or negligence in handling or use of Equipment renders the Limited Warranty void. Further, the Limited Warranty is void if, at any time, anyone other than a Trained Engineer certified by the Company acting in accordance with its training attempts to make any internal changes to any of the components of the Equipment; if at any time the power supplied to any part of the Equipment exceeds the rated tolerance; if any external device attached by End User creates conditions exceeding the tolerance of the Equipment; or if any time the serial number plate is removed or defaced. Operation of the Equipment that renders this Limited Warranty void will be defined to include all of the possibilities described in this paragraph, together with any practice which results in conditions exceeding the design tolerance of the Equipment.
7. Use of Company Name. End User shall not directly or indirectly use, reference, or otherwise employ Company’s name, trademarks, or trade name exclusively owned by or licensed to Company, except as expressly authorized by Company in writing.
8. Intellectual Property Rights. All intellectual and/or proprietary property used in or associated with the Equipment, the Company Software (as defined below), the User’s Manual, all other documentation related to the Equipment generated by Company, and any marketing materials generated by Company, including any patents, trademarks, copyrights or similar legal protections, and further including any associated trade secrets, methods or know-how (“Intellectual Property”), are owned or licensed by Company, its affiliates and its suppliers. Company hereby retains all right, title and interest in the Intellectual Property and any and all related materials and End User waives any current or future rights with respect to the Intellectual Property.
9. Company Software. With the purchase of each Sonablate System and Sonablate Insertion Pack, Company will allow Distributor to provide the applicable End User a limited, non-exclusive, nontransferable, non-licensable, revocable license to use the software embedded in the System and/or Sonablate Insertion Pack which is owned by Company (“Company Software”), solely in connection with the use of the Sonablate System and/or Sonablate Insertion Pack in accordance with the User Manual (“Software License”). The Software License is subject to the following conditions: (i) the Software License is individual to End User and End User may not distribute, rent, lease, sell, license, or otherwise transfer rights in the Company Software to any other person or entity or make any other commercial use of the Company Software without Company’s express permission; (ii) End User may not, nor allow any other person to, copy the Company Software for any purpose; (iii) End User may not, nor allow any other person to, modify, reverse engineer, decompile, disassemble or otherwise attempt to derive source code or object code from the Company Software or create derivative works based on the Company Software; and (iv) End User must retain all copyright and trademark notices on the Company Software and take reasonable steps to protect Company’s intellectual property rights. Company owns and retains all right, title and interest in the Company Software and any and all related materials and no ownership rights in the Company Software are being transferred herein.
10. Third-Party MRI-Ultrasound Fusion Software Sub-licenses. Any Third-Party MRI-Ultrasound Fusion Software sub-licenses sold to End User by Distributor as an authorized reseller designee of Company are provided “as is” with no warranties whatsoever from Company, other than those warranties expressly provided to Company by the applicable third-party, to the extent that these can be provided by Company. The applicable End User License Agreement will govern End User’s rights with respect to the Third-Party MRI-Ultrasound Fusion Software.
11. No Alteration. End User shall not and shall not permit any other party to alter, amend or otherwise change the packaging and labels of the Equipment without the prior written consent of Company. End User shall not and shall not permit any other party to or attempt to reverse engineer or otherwise alter the Equipment.
12. Notice of Events. End User will immediately give written notice and related documentation to Company if End User has knowledge of: (i) any adverse event occurring to a patient following treatment with the Equipment, (ii) theft, loss, damage to or destruction of the Equipment, and (iii) any correspondence from any governmental entity related to the Equipment or Company’s use of the Equipment. End User shall provide Company a certificate every calendar quarter confirming compliance with this Section 12 in substantially the same form as the Quarterly Certificate attached to this Certificate as Appendix 1.
13. Governing Law and Jurisdiction. This Certificate shall be governed by the laws of the State of North Carolina, United States of America. The parties hereby elect the federal courts of the District Western District of North Carolina as having jurisdiction to settle any disputes or controversies arising hereunder. The UN Convention for the International Sale of Goods shall not apply to this Certificate or the sale of the Equipment.
This Certificate is executed by the following duly authorized officer of End User as of the date below.
Appendix 1 to End User Certificate
Quarterly Certificate
| This certificate is produced in compliance with the obligations of (“End User”) under Section 12 of the End User Certificate (“Certificate”) dated ________ for the months of ________, ________, and ________ in the year ________. Any capitalized term not otherwise defined herein shall have the meaning ascribed to it in the Certificate. |
I, hereby certify that:
(Initial One) |
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No adverse events related to the Equipment occurred to patients during the months described above. |
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All adverse events occurring with relation to the Equipment during the months described above were reported to Company in accordance with Section 12 of the Certificate. |
