Terms & Conditions

These terms and conditions (“Terms and Conditions”) set forth the terms and conditions under which UroViu Corporation, (“UroViu”) will supply the customer identified in a Quote (as hereinafter defined) or Purchase Order (as hereinafter defined) (each, a “Customer”} with Devices (as hereinafter defined). These Terms and Conditions form a part of, and are hereby incorporated into, all Quotes to which these Terms and Conditions are attached ,linked or otherwise referenced and to all Purchase Orders arising out of such Quotes, regardless of whether these Terms and Conditions are specifically referenced in the Purchase Order. In the event of any conflicting, inconsistent and/or additional provisions in a customer purchase order or other document, these Terms and Conditions will supersede and prevail and such conflicting, inconsistent and/or additional provisions shall be of no force or effect; UroViu hereby objects to such other provisions or terms proposed by Customer. By accepting delivery of products from, and/or the performance of services by UroViu and/or by paying for same, Customer accepts and agrees to these Terms and Conditions, all of which, together with the applicable Quote and accepted Purchase Order, constitute the sole and entire agreement between UroViu and Customer (the “Agreement”).

Section 1. Definitions

As used in these Terms and Conditions, the following terms shall have the meanings ascribed thereto:

1. “Box” means any batch of Devices collected together into a distinct or uniform group that are identified by a shared lot or shipment number, which are delivered by UroViu.
   
   
2. “Device” or “Devices” means any medical device identified in a UroViu Quote or Purchase Order to be provided by UroViu to Customer.
   
   
3. “Documentation” means text and/or graphical materials, whether in print or electronic form, which describes the use and operation of a Device, which is provided by UroViu, or otherwise made available by UroViu, to Customer.
   
   
4. “Effective Date” means the later of (i) the date of receipt by UroViu of a Purchase Order or (ii) any effective date specified in the Purchase Order.
   
   
5. “Provider” means any health care service provider authorized by Customer to use the Device.
   
   
6. “Purchase Order” means a Customer’s standard form of purchase order submitted by Customer to UroViu and accepted by UroViu which references by number (and incorporates by such reference) any applicable Quote provided to Customer by UroViu, which Quote is attached to, linked to or which otherwise references these Terms and Conditions. Conflicting, inconsistent and/or additional provisions contained in any form of purchase order submitted by a Customer are hereby rejected and are not accepted by UroViu. Any form of a purchase order submitted by a Customer not accepted or rejected by UroViu by notification to Customer within ten (10) days will be deemed to have been rejected by UroViu.
   
   
7. “Quote” means a quotation provided by UroViu to a Customer setting forth the terms on which UroViu offers to provide products, (including Devices) to a Customer.
   
   
8. “Rebate Program” means a program pursuant to which UroViu makes available to Customer annual purchase price rebates on purchases of certain Devices if Customer satisfies certain agreed-upon purchase requirements, including pricing, time periods and quantities, as set forth in the applicable Quote and Purchase Order.
   
   
9. “Services” means any training and/or support services made available by UroViu to Customer pursuant to these Terms and Conditions.
   
   
10. “Subscription” means the agreement by Customer to purchase Devices on a continuing basis for the Subscription Term (as hereinafter defined), in quantities and at prices set forth in the applicable Quote and Purchase Order.
    
    
11. “Subscription Term” will have the meaning and duration set forth on the Quote provided by UroViu referenced on the Purchase Order.
    
    
12. “Warranty Period” means (i) for reusable products, the one (1) year period after the date of delivery and (ii) for single-use products, the shorter of (a) the period between the date of delivery and the date of use or (b) that date which is six (6) months after the date of delivery, unless otherwise set forth on the applicable Quote or Purchase Order.

Section 2. Orders & Deliveries. 

1. Orders for Devices will only be accepted by UroViu at its offices in Los Altos, California.
   
   
2. Non-Subscription Purchases. Subject to the terms herein, shipment of Devices purchased other than through a Subscription Service will take place approximately twenty-one (21) days after the Effective Date; all delivery dates are estimates only.
   
   
3. Subscription Subject to the terms herein, during the Subscription Term, UroViu will (i) ship Boxes on a monthly basis, containing the number and types of Devices set forth on the Purchase Order, and (ii) perform the Services set forth on the Purchase Order, if any. Unless other dates are specifically requested by Customer, The initial shipment to Customer will take place no more than twenty-one (21) days after the Effective Date. Thereafter, unless other dates are specifically requested by Customer, Boxes will be shipped on or about the twentieth day of each month during the Subscription Term. If Customer specifically requests a shipment date, shipments to Customer will take place no more than twenty-one (21) days after the requested shipment date. All shipment dates and all delivery dates are estimates only. UroViu shall have no liability for delayed shipments or deliveries.
   
   
4. Device Delivery. Title and risk of loss or damage will pass to Customer upon delivery to a common carrier. Customer will be responsible for all shipping, insurance and handling charges, which will be prepaid and invoiced by UroViu and shown as a separate line item on the invoice, unless other arrangements are made by Customer. UroViu will utilize Customer-designated third-party freight programs for shipment and payment when requested by Customer. In such case, Customer is solely responsible for all third-party freight charges, UroViu handling charges and any loss or damage to Devices during shipment. Prices include packaging in accordance with UroViu’s standard commercial practice. Delivery dates provided to Customer by UroViu represent UroViu’s best estimate of when the Device will be shipped. UroViu does not accept any liability for damages, losses or any other costs due to delivery delays. All shipments should be carefully examined upon receipt and, if a Device is damaged, Customer must promptly notify UroViu of the nature and extent of the damage and return such damaged Device to UroViu in accordance with Section 5.2, below. If shipments are received short, Customer must promptly contact UroViu. UroViu may make partial shipments on any order.

Section 3. Use & Restrictions

1. Limited
   
   
   1. License. All software and firmware furnished to Customer is licensed, not UroViu grants to Customer, including its Providers, a fully paid-up, royalty-free, non-transferable. non­ sublicensable, perpetual and nonexclusive license to use the UroViu software and firmware contained in the Device delivered hereunder (“Licensed Software”} solely as contained in the Device on which it was installed at shipment and in accordance with the applicable Documentation (“License”).
      
      
   2. Software Customer may not modify, reverse engineer, or otherwise attempt to derive the source code of the Licensed Software. UroViu reserves all rights in the Licensed Software not expressly granted hereunder. Customer agrees not to remove, alter, or obscure any of the copyright and other proprietary rights notices on the Licensed Software delivered hereunder, and to include the same on any copies it makes, in whole or in part. Customer acknowledges and agrees that (a) neither the licensing of the Licensed Software to Customer, nor the purchase or other acquisition of Devices by Customer constitutes a transfer of the Licensed Software, (b) the Licensed Software is the property of UroViu or the applicable third-party developer, (c) Customer neither owns nor acquires any interest in any copyright, patent or other intellectual property right in or to the Licensed Software as a result of the License granted herein or the purchase or other acquisition of any Device, and (d) UroViu, or the applicable third-party developer, retains and owns all right, title, and interest in and to the Licensed Software and the ownership rights therein, at all times, regardless of the form or media in or on which the original or any copy of the Licensed Software may exist. In the event of a failure of Customer or its agents, employees or representatives to comply with any terms and conditions of the License granted herein, the License will, without any further action by UroViu or any other party, immediately terminate.
      
      
      
2. Permitted U Customer acknowledges and agrees that: (i} the Devices are intended solely for use with humans in a clinical setting: (ii) Customer will not use, and will not permit, the use of any Devices in any animal testing: (iii) other than those Devices that are specifically designated as reusable, the Devices are single-use devices, and may not be reused, re-sterilized or repurposed for any reason: (iv) Customer will be responsible for the safe and sanitary disposal of Devices: (v} the Devices are medical devices and may only be used by appropriately trained Providers: and (vi} Customer will use the Devices in accordance with all applicable laws, rules, regulations, and ordinances.
   
   
   
3. Regulatory Inquiries. Customer covenants that it will (a} respond fully and accurately to all inquiries directed to it by any regulatory agency that may impact the quality or timely delivery of Devices and promptly notify UroViu of same, (b} assist the UroViu in responding to inquiries directed to Customer by regulatory agencies, and (c} provide regulatory agencies with such information and data as is requested by regulatory agencies with respect to the Devices.
   
   
   
4. Compliance with Laws.
   
   
   1. In General. Customer shall use the Devices only in compliance with all applicable federal, state, and local laws, rules, regulations, and ordinances, and represents that it shall have obtained all licenses and permits required by law to engage in the use of the Devices.
      
      
      
   2. Anti-Kickback Requirements. Customer shall comply with all applicable laws and regulations, including but not limited to the federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (“AKS”). Customer acknowledges its obligations to fully and accurately report the discounts, rebates, credits, product replacements (including those related to a warranty, service, or otherwise) and/or other price reductions (collectively “Discounts”), if any, it receives from UroViu, under all applicable laws and regulations, including but not limited to the AKS, the Discount Exception and the Discount Safe Harbor. Customer may be obligated to report and/or provide information concerning any such Discounts provided by UroViu pursuant to 42 U.S.C. § 1320a-7b(b)(3)(A) (the “Discount Exception”) and/or 42 C.F.R. § 1001.952(h) (the “Discount Safe Harbor”), other federal or state laws, or agreement with third-party payers. Customer should retain documentation of Discounts and make such information available to federal or state health care programs, applicable federal and/or state agencies, and/or third-party payors, upon request. UroViu will provide to Customer invoices related to purchases, and other reports/documentation as applicable, documenting any Discounts for such products and/or services. Customer is responsible for appropriate allocation and/or apportionment of any Discounts among products and/or services purchased. Customer acknowledges that this section has put Customer on notice of its obligations under the AKS, Discount Exception and Discount Safe Harbor and all other applicable laws and regulations.
      
      
      
   3. Export Control Compliance. Customer agrees to adhere to all of the requirements of the U.S. Export Administration laws and regulations with respect to the Devices and shall not export or re-export any technical data, or Device received from UroViu, or any direct product of such technical data, in violation of any applicable law. This requirement is not limited by the time period stated in this or any other agreement, and will survive the termination of this

Section 4. Price & Payment

1. Prices. Prices are subject to change without notice. Nevertheless, prices in effect at the time that a Quote is provided to Customer or a Purchase Order is accepted by UroViu will prevail; provided, however, that Quotes, including pricing therein, are valid only until the expiration date reflected on the Quote.
   
   
   
2. Payment Terms. Unless otherwise set forth in the Quote or a Purchase Order, Payments for Devices shall be made in U.S. Dollars and all amounts are due within thirty (30) days from the date of UroViu’s invoice therefor. Each shipment will be separately invoiced and paid for when due without regard to other shipm All past due payments will accrue interest at 1.0% per month on the declining unpaid balance, or the highest rate allowed by law, whichever is less. In the event of delinquency on any account, Customer agrees to pay for all collection costs, attorneys’ fees, and court costs incurred in the collection of said account, regardless of whether judicial action is taken or otherwise. If Customer does not make payment in accordance with terms of payment specified herein, UroViu may, in addition to its other remedies, at its option either (a) terminate any Subscription and related Subscription Term, (b) refuse to perform further under such Subscription until Customer cures said payment default; and/or (c) require payment in advance for all future shipments. To the extent that all or any portion of amounts payable to UroViu hereunder remains unpaid after shipment of the Devices, Customer hereby grants UroViu a continuing security interest in the Devices and all proceeds thereof to secure Customer’s payment of all amounts payable to UroViu in full, plus any accrued interest as specified in this Section 4.2. .Amounts payable to UroViu for the purchase of Devices and/or the provision of services are not subject to withholding, set-off or counter-claim under any circumstances without the prior written consent of UroViu.
   
   
   
3. Taxe All prices for Devices are exclusive of federal, state, or local sales, use, excise, or similar taxes applicable to the sale or to the Devices sold, except taxes based upon UroViu’s income. Any such taxes shall be separately itemized on UroViu’s invoices and Customer agrees to assume and pay or cause to be paid any and all such taxes and other charges incidental to the purchase or sale of such Devices, or, in lieu thereof, if Customer is a governmental agency or other entity that is exempt from such taxes, Customer shall furnish UroViu with a properly executed tax exemption certificate for the “sold to” entity at the time of issuance of the Purchase Order.
   
   
   
4. Cancellation.
   
   
   1. Subscription. Customer may terminate a Subscription and Subscription Term without cause at any time upon no less than thirty (30) days’ prior written notice; provided, however, that in the event of any such termination, pricing otherwise available to Customer during the Subscription Term shall be immediately canceled and all subsequent purchases shall be at then-current list price unless Customer enters into a subsequent agreement for Subscription Services at prices to be established at the time of such agreement.
      
      
      
   2. Rebate Program. UroViu may review purchases under a Rebate Program from time to time. If, after such review and discussion with Customer, UroViu determines that Customer will not be able to meet the requirements of an applicable Rebate Program (e.g., Customer will not be able to achieve a base rebate threshold quantity (as may be defined in the Rebate Program)), UroViu may terminate such Rebate Program upon not less than sixty (60) days’ prior written notice. In the event of any such termination, pricing otherwise available to Customer under the Rebate Program shall be immediately canceled and all subsequent purchases shall be at then-current list price unless Customer enters into a subsequent agreement for a Rebate Program at prices to be established at the time of such agreement.

Section 5. Warranty and Disclaimers

1. Warranty
   
   1. UroViu warrants that Devices furnished to Customer will substantially conform with UroViu’s applicable published specifications and be free in all material respects from defects in material and workmanship for the Warranty Period. UroViu also warrants that title to all Devices delivered to Customer hereunder will at the time of delivery be free of any liens of any kind whatsoever. UroViu will at its own expense and option, and as Customer’s sole and exclusive remedy for any breach of this warranty, repair or replace any reusable Device, and replace any single-use Device, that does not conform to the foregoing warranty, or, if UroViu determines that such options are not commercially reasonable, refund the monies paid by Customer for the non­conforming Device; provided that Customer notifies UroViu of any Device that does not conform to the foregoing warranty during the Warranty Period. Customer must return non­conforming Devices to UroViu in accordance with the procedures set forth in Section 6.1, below. Any replacement reusable Device will be new or reconditioned; any replacement single-use Device will be new. Transportation charges on any Device returned from Customer to UroViu will be at UroViu’s The warranty provided under this Section 5.1.1 will be void if (a) a Device fails or malfunctions as a result of improper handling, installation, maintenance, removal, modification, or repair; (b) a Device is damaged, or subjected to abuse, abnormal physical or electrical stress, or improper use; (c) a Device is used with software, hardware or equipment not authorized by UroViu; (d) a reusable Device is used with any reagent or consumable/single-use product not supplied by UroViu; (e) a Device or any component thereof is returned in improper packaging; (f) a Device is repurposed; or (g) a single-use Device is re-used, and/or re­sterilized (collectively, “Excluded Claims”).
      

   2. EXCEPT FOR THE EXPRESS WARRANTY SET FORTH IN SECTION 5.1.1, THE DEVICE IS PURCHASED BY CUSTOMER “AS IS,” ENTIRELY AT ITS OWN RISK AS TO ITS QUALITY AND PERFORMANCE, IN RELIANCE SOLELY UPON ITS OWN INSPECTION OF THE EQUIPMENT AND WITHOUT RELIANCE UPON ANY OTHER REPRESENTATION OR DESCRIPTION BY UROVIU. UROVIU MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, AND HEREBY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT AND ANY WARRANTIES ARISING UNDER OR AS A RESULT OF ANY STATUTE, LAW, COMMERCIAL USAGE, CUSTOM, TRADE, COURSE OF CONDUCT OR OTHERWISE. NO STATEMENT BY ANY EMPLOYEE OR REPRESENTATIVE OF UROVIU WILL CONSTITUTE A WARRANTY. Any contrary course of performance by and between the Parties will not modify any representations and/or warranties set forth in this Section 5. UroViu neither assumes nor authorizes any person to assume for it any other liabilities in conjunction with and/or related to the sale and/or use of any Devices or provision of services by UroViu. To ensure proper use, handling and care of the Devices, Customer should consult the product- specific literature, instruction manual and/or labeling included with the Devices or otherwise available. Repair, modification or alteration of any Device performed by any person or entity other than by UroViu nullifies and otherwise voids all applicable UroViu warranties. Repair or replacement of a Device shall not extend the term of any applicable warranty. The remedies provided herein are Customer’s exclusive remedies under this Section 5.

Section 6. Device Returns

1. Return Material Authorization Process. Before returning any Device or product to UroViu for any reason, Customer must obtain a Return Material Authorization (RMA) number from UroViu and all return documentation must contain UroViu’s RMA. UroViu will not unreasonably delay or withhold the issuance of an RMA number. Returned shipments not properly identified with an RMA number will be refused by UroViu. The foregoing notwithstanding, prior to refusing such shipment, UroViu will first contact Customer to resolve any identification deficiencies. The request for an RMA number must include the applicable Purchase Order number, serial numbers when possible and full identification of the Device or product to be returned and reason for the return, and, if a warranty return, must reasonably identify how the returned Device or product fails to conform to the warranty set forth in Section 5.1. UroViu will not be responsible for Devices or products returned without an RMA. Returns must be carefully packed and shipped pre-paid to UroViu, Attn: RMA number.
   
   
2. Return Policy. A credit equal to the original invoiced price (not including taxes, shipping, insurance or handling) less a 25% restocking fee will be issued for Devices or products that are received by UroViu within sixty (60) days of date of shipment (“Ship Date”) so long as such items are unused and in resalable condition and, for sterile-packaged Devices or products, the sterile package is unaltered. Proper handling procedures must be used in the packing and shipping of all returned Devices and products. Returned Devices and products must be returned in the original and/or an equivalent container and have the RMA number clearly visible on the package; in addition, all returned sterile-packaged Devices or products must be returned in their original packaging. In addition to the RMA requirements set forth in Section 6.1, above, warranty returns must be packaged only in accordance with UroViu’s warranty return procedures, which will be provided to Customer at the time an RMA for a warranty claim is requested. If any Device or product becomes damaged and is not immediately returned for repair or exchange, UroViu assumes no responsibility or liability for Customer’s continued use of that damaged Device or product. UroViu does not guarantee the performance of, and may decline to repair or accept for repair/exchange, any Device or product that has been repaired, modified and/or altered by any person or entity other than UroViu or a UroViu authorized repair facility. Shipping charges will be reimbursed, restocking fees, and inspection fees will not be charged and full credit will be given if the return was due to a shipping error on the part of UroViu. Customer must follow the RMA procedure set forth in Section 6.1, “Return Merchandise Authorization Process”, above, to return Devices or products for credit. The following Devices or products may not be returned for credit or exchange: (a) Devices or products held longer than sixty (60) days from Ship Date; (b) sterile packaged Devices or products where the sterile package is opened and/or damaged; (c) Devices or products identified and purchased as discontinued products; (d) Devices or products that are etched or engraved by customer; (e) Devices or products damaged by customer; and (f) used Devices or products.

Section 7. Termination

Each of UroViu and Customer will have the right to terminate a Subscription or Rebate Program by written notice to the other if the other materially breaches the terms of the Subscription or Rebate Program and fails to cure such breach, or implement a corrective action plan designed to cure the breach, within thirty (30) days after receiving written notice of the breach from the non-breaching party and if such breach still has not been cured, or a corrective action plan still has not been implemented, when the termination notice is given.

Section 8. Limited Liability

EXCEPT FOR BREACHES OF SECTION 9, IN NO EVENT WILL UROVIU BE LIABLETO CUSTOMER FOR COST OF COVER OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, WHETHER OR NOT FORESEEABLE, EVEN IF UROVIU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, INCLUDING BUT NOT LIMITED TO, LOSS OF REVENUE, LOSS OF GOODWILL, OR LOSS OF PROFITS, ARISING FROM THE PURCHASE, SALE, PERFORMANCE, NON-PERFORMANCE, OR USE OF UROVIU DEVICES OR SERVICES OR OF ANY OBLIGATION HEREIN, WHETHER ARISING OUT OF CONTRACT, TORT OR ANY OTHER LEGAL OR EQUITABLETHEORY. IN NO EVENT WILL UROVIU’S LIABILITY UNDER ANY QUOTE, PURCHASE ORDER OR AGREEMENT, INCLUDING THE PERFORMANCE OF UROVIU’S INDEMNIFICATION OBLIGATIONS HEREIN, EXCEED THE AMOUNTS PAID BY CUSTOMER TO UROVIU DURING THE TWELVE (12) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT(S) GIVING RISE TO LIABILITY HEREUNDER. SOME JURISDICTIONS DO NOT ALLOW EXCLUSIONS AND DISCLAIMERS OF CERTAIN WARRANTIES OR LIMITATIONS OF LIABILITY, SO THE LIMITATIONS AND/OR EXCLUSIONS SET FORTH IN THESE TERMS AND CONDITIONS MAY NOT APPLY. IN THAT EVENT, UROVIU’S LIABILITY WILL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW IN THE SUBJECT JURISDICTION.

Section 9. Protected Health Information

UroViu acknowledges that Customer may be, or is, a “covered entity” as that term is defined at 45 C.F.R. §160.103. In connection with the performance of services hereunder, UroViu may be, or is a “business associate” under the Health Insurance Portability and Accountability Act of 1996, as codified at 42 U.S.C.A. §1320d et seq. (“HIPAA”) and any current and future regulations promulgated thereunder. If, and to the extent, applicable to UroViu’s performance hereunder, UroViu shall comply with HIPAA and with comparable or similar laws, statutes, regulations and/or directives related to privacy of personal and/or personal health information, to the extent applicable, of the United States (“Federal Privacy Regulations”). UroViu further agrees not to use or further disclose any Protected Health Information (as defined in the Federal Privacy Regulations), other than as permitted by the Federal Privacy Regulations and the terms of this Agreement; and to enter into any further mutually-acceptable business associate agreements to the extent required for compliance with HIPAA.

Section 10. General

1. Assignement. Either UroViu or Customer may assign a Purchase Order, Subscription or Rebate Program to a successor or affiliate in connection with a reorganization, acquisition, merger. or similar transaction, provided that the successor or affiliate agrees to assume and fulfill all of such party’s ongoing and future obligations under such Purchase Order, Subscription or Rebate Program. All obligations and duties of either party under such Purchase Order, Subscription or Rebate Program shall be binding on all successors in interest and assigns of such party. Except as expressly permitted above, neither party may assign, delegate or otherwise transfer any of its rights or obligations under any Purchase Order, Subscription or Rebate Program to any third party without the other party’s express prior written consent, and any attempted assignment, delegation or transfer in violation of the foregoing will be null and void.
   
   
2. Force Majeure. UroViu will not be held liable for, or be deemed in breach of any Purchase Order or Subscription as a result of, any delay or failure in performance by UroViu arising from any cause beyond its reasonable control and without its fault or negligence, such as acts of God, acts of civil or military authority, terrorism, government regulations, embargoes, epidemics, pandemics, war, terrorist acts, riots, insurrections, fires, explosions, earthquakes, nuclear accidents, floods, power blackouts, unusually severe weather conditions, inability to secure products or services of other persons or transportation facilities, or acts or omissions of transportation common carriers.
   
   
3. Governing Law and Dispute Resolution. All controversies, disputes and claims, other than collection and payment controversies, disputes and claims, shall be adjudicated by a court of competent jurisdiction within the County of Los Angeles, State of California or the United States District Court, Northern District of California, which courts shall have exclusive jurisdiction over such matters. All collection and payment controversies, disputes and claims shall be adjudicated by any court of competent jurisdiction within the State of domicile of Customer or the United States District Court having jurisdiction over Customer, All transactions by and between Customer and UroViu shall be governed by and construed in accordance with the laws of the State of California without regard to its conflict of laws principles. The invalidity or unenforceability of any of the within Terms and Conditions will not affect the validity or enforceability of any other or remaining term or condition hereof or of the agreement between the parties.

UROVIU/SHORTFORMT&CS  25Apr24
SLTG 2100004_4 / 2100-0001