Francis Medical, Inc. (“Francis Medical”) has developed the Trident+ system, a medical device that utilizes proprietary water vapor ablation technology to treat prostate cancer (“Trident+”)that is used with certain disposable components (the “Trident+ Supplies” and, together with Trident+, the “Trident+ System”). “Customer” means the legal entity thatexecutes a Customer Agreement and Enrollment Form (“Agreement”)touse Trident+ on a fee per use model and purchases theTrident+ Supplies. By executing the Agreement, Customer agreed to be bound by the following terms and conditions.

  1. Fee Per Use. From time to time the Customer may place orders for use of the Trident+ System by executing and submitting an Order Form to Francis Medical in the format attached as Exhibit C to the Agreement (“Order Form”).Customer will indicate the date upon which the Trident+ unit is needed and its purchase quantity of Trident+ Supplies on the Order Form. Subject to Francis Medical’s acceptance ofthe Order Form, which it may accept or reject in its sole discretion,Francis Medical, or its designee, will deliver each Trident+ unit on the date specified, as requested by Customer on the Order Form. Completing an Order Formdoes not transfer to Customer title to Trident+ units, and title to Trident+ units will remain with Francis Medical.
  2. Payment Terms.Customer shall pay all applicablefees per use andTrident+ Suppliespurchase feesand other amounts due hereunder in accordance with pricing terms contained in Exhibit A to the Agreement (collectively, “Fees”) within 30 days from the applicable invoice date. If Customer fails to pay any amounts when due, Francis Medical reserves the right to charge interest on the overdue amount at a rate of 5% per month. In the eventFrancis Medicalmust take action to collect any unpaid amounts from Customer, Customer will be responsible for all costs and expenses, including but not limited to attorneys’ fees, court costs, and any other related costs, incurred by Francis Medical in connection with such collection.Invoices hereunder may be paid by Customer via credit card, ACH, or wire transfer. Francis Medical reserves the right to suspend the shipment of Trident+ Supplies, Customer’s access to and use of the Trident+System,or cease the performance hereunder if any amountremain overdue for 30 days or longer.The Fees are exclusive of taxes. Francis Medical will invoice Customer for any taxes due hereunder at the time of invoicing the Fees; provided that no such taxes will be invoiced to the extent Customer has notified Francis Medical in writing that no such taxes are required to be collected by Francis Medicaldue to Customer’s tax-exempt status and has providedreasonable evidence of its tax-exempt status. The Fees have been determined by the Parties through good faith and arms-length bargaining to be the fair market value for the goods and services to be provided hereunder.
  3. Intellectual Property. Francis Medical hereby grants to Customer a non-exclusive, non-transferable, non-sublicensable right to use Trident+on the dates specified by Customer on the Order Formsolely for Customer’s internal business purposes in the United States in accordance with Trident+’sUser Manual made available by Francis Medical to Customer.Francis Medical is the sole owner of Trident+, including any Intellectual Property Rights therein. Francis Medical reserves all rights, title and interests in and to Trident+, other than those expressly granted to Customer hereunder. Francis Medical shall have the right to display notice of its ownership of Trident+ by affixing identifying labels, signs, symbols, serial numbers or other indicia of ownership and Customer shall not remove or deface such notices. As used herein, “Intellectual Property Rights” include without limitation any know how, trade secret, invention, discovery, patent, utility model, copyright, trademark, industrial design, process, formula, technique, or any other tangible or intangible right or privilege of any nature, in all cases applicable all over the world and whether registered or not.
  4. FDA Matters. The U.S. Food and Drug Administration (“FDA”) has granted marketing clearance for the Trident+ System under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”). Customer will comply with all applicable federal, state, and local laws with respect to the Trident+ System, including the FFDCA and its implementing regulations, and to use the Trident+ System in a manner consistent with the device labeling provided by Francis Medical, include the User Manual and any other instructions for use.
  5. Adverse Events. Customer shall notify Francis Medical of all suspicions of serious adverse events due to the Trident+ System, all serious undesirable events likely to be related to the procedure, any device deficiency, or any new finding within twenty-four (24) hours of the receipt of information by the site.
  6. Product Complaints. Customer will notify Francis Medical in writing within two (2) business days of becoming aware of any written, electronic, or oral communication alleging deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the Trident+ System. Compliance with this obligation shall not relieve Customer of the separate duty to comply with the adverse event reporting requirements above.
  7. Recalls. If (a) any governmental authority issues an official request, directive, order or advice that the Trident+ System be recalled (including any product removal or correction), (b) a court of competent jurisdiction orders such a recall, or (c) Francis Medical determines that a recall or market withdrawal of the Trident+ System is required, Francis Medical shall have the sole right to control the implementation of such recall or market withdrawal and take all appropriate corrective actions that it deems necessary for a recall or market withdrawal of the Trident+ System. Francis Medical shall conduct such recall or market withdrawal after providing written notice to Customer. Customershall provide Francis Medical with all reasonable cooperation to administer a recall or market withdrawal.
  8. Use of the Trident+ System. Customer will ensure that the Trident+ System is only used by duly qualified personnel, in a safe and reasonable manner, and in accordance with Francis Medical’s written instructions. Customer represents and warrants that it is duly authorized to usethe Trident+ System with or without the presence of an operating aid in the operating room and that it is in compliance with any applicable medical practice licensing requirements. Customer will not attempt to maintain, service, or repair the Trident+ System without Francis Medical’s prior written consent. Customer will grant Francis Medical’s personnel and independent contractorsaccess to the Trident+ System while at a Customer controlled location, including toFrancis Medical’s clinical account managers and any additional support staff.Customer will reasonably cooperate with Francis Medical upon request to provide appropriate counts of Customer’s remaining stock of Trident+ Supplies. The Customer agrees it will only use Trident+ Supplies in connection with Trident+ units and will not transfer to any third party or destroy any Trident+ Supplies. If Customer believes any Trident+ Supplies may be defective or otherwise compromised, Customer should not use such Trident+ Supplies, should quarantine them,and promptly contact Francis Medical to arrange for collectionand inspection of the Trident+Supplies.
  9. Warranty. The Company warrants that reasonable care was used in the design and manufacture of Trident+. THIS WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES NOT EXPRESSLY SET FORTH HEREIN, WHETHER EXPRESS OR IMPLIED BY OPERATION OF LAW OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ALL OF WHICH ARE HEREBY EXPRESSLY DISCLAIMED. Handling, storage, cleaning and sterilization of Trident+ as well as other factors relating to the patient, diagnosis, treatment, and other matters beyond the Company’s control directly affect the device and the results obtained from its use. This warranty does not cover damage resulting from misuse, abuse, accident, or unauthorized alterations. The Company’s obligation under this warranty is limited to the repair or replacement of the device. The Company neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with the device.
  10. Confidentiality.”Confidential Information” means any data or information disclosed by Francis Medical to Customer that is identified as confidential or proprietary or that, having regard to its nature or the circumstances of its communication, should reasonably be considered confidential or proprietary (“Confidential Information”). All drawings, data, designs, software programs and other technical information provided by Francis Medical to Customer in connection with the Trident+ System are the Confidential Information of Francis Medical. Customer agrees to use the Confidential Information only for purposes of this Agreement, keep the Confidential Information in the strictest confidence and to protect it from disclosure with the same degree of care it takes to protect its own information of similar importance. Customer shall limit the disclosure of Confidential Information to its affiliates, and its and their employees, contractors, agents, attorneys, auditors, directors, officers, investors, financing sources, and other representatives (collectively, “Representatives”) who have a reasonable need to know and who are subject to an obligation of confidentiality that is substantially the same as those set forth herein. Customer will be responsible for any act or omission of its Representatives in violation hereof. The obligations of this Section shall survive termination of this Agreement.
  11. Customer Indemnity. Customer agrees to defend, indemnify, and hold harmless Francis Medical and its officers, directors, employees, and contractors from and against any and all claims, demands, suits, liabilities, judgments, costs, and other losses (including reasonable attorneys’ fees, expert fees and other litigation costs) (collectively, “Losses”) arising out of or in connection with Customer’s improper use of the Trident+ System or Customer’s negligence or willful misconduct.
  12. Francis Medical Indemnity. Francis Medical agrees to defend, indemnify, and hold harmless Customer and its officers, directors, employees, and contractors from and against any and all Losses arising out of or in connection with the infringement by Trident+ of any third-party United States intellectual property right, except to the extent caused by: (i) the combination, or use of Trident+ in combination, with any products, services, software, data or materials not provided by Francis Medical or (ii) any alteration, modification, or revision of Trident+ not performed by Francis Medical. If Francis Medical reasonably believes Trident+ may infringe any third party’s rights, Francis Medical may, at its option, (A) obtain the right for Customer to continue using Trident+; (B) modify or replace Trident+ so it is not infringing or misappropriating; or (C) if (A) and (B) are not commercially reasonable, terminate the Agreement and provide a refund of any prepaid Fees for Trident+. If Customer receives a claim that Trident+ infringes any third-party rights, Customer will notify Francis Medical immediately in writing.
  13. LIMITATION OF LIABILITY. EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS, GROSS NEGLIGENCE OR INTENTONAL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR (A) ANY PUNITIVE, EXEMPLARY, MULTIPLIED, INDIRECT, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITEED TO, LOSS OF DATA, LOSS OF USE OR AVAILABILITY, INACCURACY OR CORRUPTION OF DATA, LOST PROFITS OR REVENUES, AND (B) AGGREGATE LIABILITY IN AN AMOUNT IN EXCESS OF ONE MILLION DOLLARS ($1,000,000).
  14. Insurance. Customer will, at its own expense, maintain the following insurance: (i) commercial general liability insurance on an occurrence basis in an amount equal to $2,000,000 per occurrence; (ii) Workers’ Compensation Insurance of an amount and scope of which shall meet any requirements imposed by statute or other applicable law; and (iii) property and casualty insurance or leased equipment insurance covering the Trident+ System while on Customer’s premises in an amount equal to $2,000,000per occurrence. Customer shall deliver written evidence of such required insurance coverages within five days of any Francis Medical written request for the same.
  15. Communications. Subject to the other Party’s prior written approval not to be unreasonably withheld, each Party may publicly disclose that the Customer is using the Trident+ System and is a customer of Francis Medical, including in any marketing or promotional materials, websites, and press releases of either Party; provided that any use of the other Party’s trademarks will be in accordance with any written trademark guidelines provided by such Party.
  16. Assignment. Customer may not assign, transfer or delegate any of the rights or obligations hereunder without the prior written consent of Francis Medical. This Agreement may be assigned by Francis Medical to an affiliate, a successor entity or any entity created or acquired as a result of a corporate reorganization, merger, acquisition or the purchaser of substantially all of Francis Medical’s assets. Customeragrees Francis Medical may engage subcontractors in connection with its performance hereunder;provided that it remains responsible for such subcontractors’ performance hereunder.
  17. Entire Agreement; Amendments. The Agreement and each Exhibit thereto (i) supersedes all previous understandings, agreements and representations between the Parties, written or oral and (ii) constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof,. No modification, change or amendment to this Agreement will be effective unless in writing and signed by each of the Parties. In the event Customer issues an order form, purchase order, or any other document to Francis Medical it is agreed that such order form, purchase order, or other similar document is issued solely for purposes of authorization and Customer’s internal use only and the terms and conditions of which shall have no force or effect and shall not amend, modify or supplement the terms of the Agreement.
  18. Force Majeure. Francis Medical shall not be liable for any failure to perform or delay in performance resulting directly or indirectly from any event beyond Francis Medical’s reasonable control, including strikes or other labor disputes, acts of God, war, accidents, pandemics, epidemics, fires, floods, disasters, inclement weather, transportation, unavailability of materials or labor, delays caused by suppliers, or laws, regulations or acts of any government agency or body.
  19. Governing Law and Venue. The Agreement shall be interpreted, and the rights and liabilities of the Parties hereto determined, in accordance with the laws of the State of Minnesotawithout regarding conflict of laws principles.Any action or proceeding brought by any Party relating in any way to the Agreement will be brought and enforced in the courts of the State ofMinnesota, and the Parties hereto irrevocably submit to the exclusive jurisdiction for such courts in respect of any such action or proceeding.The Parties exclude the application to the Agreement of the United Nations Convention on Contracts for the International Sale of Goods.