These Terms and Conditions, together with any separately executed order form(s) (“Order Form(s)”), constitute the entire agreement (“Agreement”) between Open Water Internet, Inc. with offices at 733 Front Street, Suite C1A, San Francisco, CA 94111 (“Openwater”), and the customer identified in the Order Form (“Customer”). This Agreement becomes effective on the date specified in the Order Form. This Agreement (Product Sale Terms and Conditions) is supplemented by: Exhibit A (Product Specifications) and Exhibit B (if applicable): Openwater Services and Support Agreement. If Services are purchased, Exhibit B is incorporated into the applicable Order Form.
1. SALE OF PRODUCT; DELIVERY
1.1 Subject to the terms and conditions set forth herein, Openwater will sell to Customer, and Customer will purchase from Openwater the quantity of Product set forth in the Order Form.
1.2 Unless otherwise set forth in writing by Openwater, all shipments of Product are made F.O.B. Openwater’s manufacturing facility. Title and risk of loss in the Product will pass to the Customer upon delivery of the Product to the shipping carrier. Openwater may, in its sole discretion, without liability or penalty, make partial shipments of the Product to Customer.
1.3 In the absence of specific shipping instructions, Openwater will ship Product by the method it deems most advantageous. Transportation charges will be collected on delivery or, if prepaid, will be subsequently invoiced to Customer. Unless otherwise indicated, Customer is obligated to obtain insurance against damage to the Product being shipped. Customer shall bear complete and exclusive responsibility for promptly advising the carrier and insurer of any loss or damage and for filing claims against, and recovering any sums owed by, the carrier or the insurer.
1.4 Customer will notify Openwater of any failure of a Product to comply with the specifications set forth in Exhibit A (“Nonconforming Product”) within fifteen (15) days after receiving such Product or Customer will be deemed to have accepted such Product. If Customer timely notifies Openwater of any such Nonconforming Product, Openwater shall, in its sole discretion, either (i) repair or replace such Nonconforming Product at Openwater’s expense and risk of loss within thirty (30) days of notification, or (ii) credit or refund the Product Purchase Price for such Nonconforming Product, in each case after Customer ships the Nonconforming Product to Openwater at Openwater’s expense and risk of loss. Customer acknowledges that the remedies set forth in Section 1.4 are Customer’s exclusive remedies for delivery of a Nonconforming Product. Except as provided in this Section 1.4, all other sales of the Product are final and not subject to returns or exchanges.
2. SERVICES
2.1 Service Categories. If Customer purchases Services (such as Orientation & Training, Support Services, Maintenance Services, or Professional Services), those Services are governed by the separate Openwater Services and Support Agreement ("Services MSA"), which is incorporated herein by reference and attached as Exhibit B to the applicable Order Form.
2.2 Product-Only Purchases. If Customer purchases only Product(s) and no Services, this Agreement governs exclusively, and the Services MSA does not apply.
2.3 Conflicts. In the event of any conflict between this Agreement and the Services MSA, the Services MSA governs with respect to Services; this Agreement governs with respect to Product sales and the one-year Product warranty and related Product-side limitations of liability.
3. WARRANTY; WARRANTY DISCLAIMER
3.1 Limited Product Warranty; Scope; Exclusions. Subject to the terms and conditions of this Agreement, Openwater warrants to Customer that, for a period of one (1) year following the shipment date (the “Warranty Period”), each Product, when used under normal conditions and in accordance with Openwater’s then-current documentation, will (a) comply with the specifications in Exhibit A and (b) be free from defects in materials and workmanship (the “Limited Product Warranty”). This Limited Product Warranty applies only to the original purchaser identified on the applicable Order Form and is not transferable.
If Customer at any time believes there has been a breach of the Limited Product Warranty, Customer will promptly notify Openwater’s Designated Warranty Contact during the Warranty Period. If Openwater can independently verify that a failure to meet Specifications or a defect in materials or workmanship exists and is attributable to the Product and not any third-party equipment or any third-party act or omission (a “Defect”), Openwater will use commercially reasonable efforts to address the problem at no cost to Customer. If such efforts fail to correct the Defect, Openwater will, at its sole option, repair or replace the affected Product, or, if Openwater determines in its sole discretion that is not possible or reasonably practical to do so, grant Customer a refund as described in Section 3.3.
Customer will provide reasonable access and cooperation in order to permit Openwater to verify the Defect and perform its obligations in this Section 3.1. Customer understands and agrees that failure to do so will prevent Openwater from performing such obligations, and voids the Limited Product Warranty set forth herein.
The Limited Product Warranty does not apply to, and Openwater will have no obligation under this Section 3.1 with respect to: (i) damage, failure, or malfunction resulting from misuse, abuse, accident, neglect, improper handling, or failure to follow Openwater’s recommended maintenance, installation, and operating procedures; (ii) damage caused by external or environmental factors, including without limitation fire, flood, power surges, power outages, natural disasters, or other events outside Openwater’s reasonable control; (iii) normal wear and tear from extended use; (iv) any Product that has been modified, repaired, or serviced by anyone other than Openwater or its expressly authorized service providers; (v) consumables, disposable components, or other items intended to be replaced in the ordinary course of use; or (vi) software issues caused by unauthorized third party software, integration, or user error.
Openwater will have sole discretion to determine whether a reported issue constitutes a Defect covered by this Limited Product Warranty and, if so, whether repair, replacement, or refund is the appropriate remedy under this Agreement.
3.2 If Openwater opts to replace or repair a Product suffering from a Defect, it will bear the cost of freight and insurance to the point of repair or return and for return of a repaired or replacement Product to Customer. Any Product repaired or replaced by Openwater will be covered by the warranty described in Section 3.1 only for the remainder of the warranty period for the original Product.
3.3 If Openwater elects to provide a refund for a Defect, the refund will equal the original purchase price paid by the Customer, reduced on a straight-line basis over one (1) year from the shipment date. For example, after six months, the refund will be 50% of the purchase price.
3.4 THE REMEDY CHOSEN BY OPENWATER ACCORDING TO SECTION 3.1 IS CUSTOMER’S SOLE REMEDY, AND OPENWATER’S SOLE LIABILITY, WITH RESPECT TO ANY BREACH OF WARRANTY UNDER THIS AGREEMENT. EXCEPT AS SET FORTH IN SECTION 3.1, THE PRODUCT, AND ANYTHING ELSE PROVIDED IN CONNECTION WITH THIS AGREEMENT ARE PROVIDED “AS-IS,” WITHOUT ANY WARRANTIES OF ANY KIND. OPENWATER HEREBY DISCLAIMS (ON BEHALF OF ITSELF AND ITS LICENSORS AND SUPPLIERS) ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT.
3.5 Services Not Covered by Product Warranty. The one-year warranty set forth in Section 3.1 applies exclusively to the Product and does not extend to any Services (including Orientation & Training, Support Services, Maintenance Services, or Professional Services). Services are governed by the separate Services MSA and are provided without warranty of success, outcome, or availability. See the Services MSA for the specific warranties, if any, applicable to each Service type.
4. INTELLECTUAL PROPERTY RIGHTS; OPEN SOURCE TECHNOLOGY
4.1 Certain of Openwater’s intellectual property is available to the public pursuant to (a) an open source license, (b) a creative commons license, or (c) a patent pledge, respectively (collectively such rights licensed thereunder, the “Open Source Technology,” and the applicable license(s) and pledge, the “Open Source Terms”). The Open Source Technology includes certain software code available here that is installed on or otherwise integral to the use of the Products (the “Open Source Code”), which Open Source Code is licensed under the GNU Affero General Public License. For more details regarding the Open Source Technology and the respective Open Source Terms, please see https://www.openwater.health/opensource.
4.2 “Proprietary Software” means the object code version of all software (a) installed on the Products, or (b) otherwise provided by Openwater to Customer hereunder as complementary to use of the Products; except for, in each case, the Open Source Code. Subject to all terms and conditions of this Agreement, Openwater grants Customer a perpetual, limited, non-exclusive, non-transferable, non-sublicensable, revocable right to use the object code version of the Proprietary Software, solely in the form provided by Openwater. This Agreement is a license, not a sale, of Proprietary Software and does not convey to Customer any rights of ownership in or related to the Proprietary Software.
4.3 Openwater alone (and its licensors and suppliers, where applicable) will retain all intellectual property rights relating to (a) the Product, (b) the Proprietary Software, (c) the Services, (d) the Open Source Technology, (e) any suggestions, ideas, enhancement requests, feedback, recommendations or other information provided by Customer or any other party relating to the subject matter hereunder (“Feedback”), which are hereby assigned to Openwater, and (f) all improvements to the Product derived from Safety Data (defined below).
5. RESTRICTIONS AND RESPONSIBILITIES
5.1 The Product is provided for research use only. Customer agrees to use the Product for research only and not for any therapeutic or diagnostic purpose or any other use for which the results are used to determine the course of patient care. Customer acknowledges that (i) the Product has not been approved, cleared, or licensed by the United States Food and Drug Administration or any other regulatory entity whether foreign or domestic for any specific intended use, whether research, commercial, diagnostic, or otherwise, and (ii) Customer must ensure it has any regulatory approvals that are necessary for Customer’s intended uses of the Product. The Products must be used only in a lawful and ethical manner. Customer will comply with all applicable laws, regulations, and ethical guidelines promulgated by established national and international ethical bodies when using, maintaining, and disposing of the Products and the information generated from the use of the Product.
5.2 Customer will use the Product and Services in compliance with all applicable laws and regulations and will not and will not permit any third party to use the Product, Open Source Technology, Proprietary Software or Services in any infringing, defamatory, harmful, fraudulent, illegal, deceptive, threatening, harassing, or obscene way.
5.3 Customer will not, and will not permit any third party to: (i) reverse engineer, decompile, disassemble or otherwise attempt to discover or obtain the source code, object code or underlying structure, ideas or algorithms of the Products, Proprietary Software, Open Source Technology, Services or any related documentation or data provided by Openwater (provided that reverse engineering is prohibited only to the extent such prohibition is not contrary to applicable law); (ii) modify, translate, or create derivative works based on the Products, Proprietary Software, Open Source Technology or Services; or (iii) resell or provide the Product, Proprietary Software, Open Source Technology or Services to any third party, without Openwater’s prior written consent. Notwithstanding the foregoing, the foregoing shall not apply to each item of Open Source Technology, solely to the extent the foregoing is in conflict with the Open Source Terms applicable to such item.
5.4 Any breach of this Section 5 or any other breach of this Agreement by Customer will immediately (a) void the warranty set forth in Section 3.1 and (b) terminate any obligation of Openwater to provide any Services. The foregoing does not limit any other legal or equitable remedy available to Openwater.
5.5 Customer will be responsible for maintaining the security of Customer account, passwords (including but not limited to administrative and user passwords) and files, and for all uses of Customer account with or without Customer’s knowledge or consent.
5.6 Customer acknowledges and agrees that the Services operate on or with or using equipment and/or other services operated or provided by third parties (“Third Party Services”). Openwater is not responsible for the operation of any Third Party Services nor the availability or operation of the Services to the extent such availability and operation is dependent upon Third Party Services. Customer is solely responsible for procuring any and all rights necessary for it to access Third Party Services and for complying with any applicable terms or conditions thereof. Openwater does not make any representations or warranties with respect to Third Party Services or any third party providers. Any exchange of data or other interaction between Customer and a third party provider is solely between Customer and such third party provider and is governed by such third party’s terms and conditions. Openwater shall not have any liability whatsoever to the other with respect to damages caused by: (i) electrical outages, power surges, brown-outs, utility load management or any other similar electrical service interruptions whatever the cause; (ii) interruptions in wireless or cellular service linking Product to the Services; (iii) interruptions attributable to unauthorized Openwater network intrusions; or (iv) interruptions in services provided by any internet service provider. This includes the loss of data resulting from such electrical, wireless, cellular or Internet service interruptions.
5.7 The Product is labeled and provided solely for research use. It is not intended for use in diagnostic or therapeutic procedures. The Customer shall not use, or permit the use of, the Product for any purpose other than research, nor make any representation, express or implied, that the Product is safe or effective for any medical or diagnostic use. The Customer is solely responsible for obtaining all necessary regulatory approvals, including IRB approval and informed consent, prior to any research involving human subjects. The Customer shall ensure that all labeling, documentation, and communications regarding the Product clearly state: “For Research Use Only. Not for use in diagnostic procedures.” Any data generated using the Product may not be used to support clinical decisions or patient care, nor submitted for regulatory approval without Openwater’s prior written consent. The Customer shall indemnify and hold Openwater harmless from any claims, damages, or liabilities arising from the Customer’s use of the Product, including but not limited to regulatory violations, failure to obtain IRB approval, or misuse of the Product.
5.8 Services Delivery and On-Site Responsibilities. If Services (such as on-site Orientation & Training or Clinical-Technical Support) are provided, the following apply:
(a) Scope. The scope, timeline, deliverables, and site responsibilities for Services are set forth in the Services MSA and the applicable Order Form. This Section 5 (Product Restrictions) applies only to restrictions on the Product itself, not to Openwater's provision of Services.
(b) On-Site Access. If Services are performed at Customer's facilities, Customer grants Openwater and its personnel reasonable access to the necessary workspace, electrical power, computing equipment, and facilities required to deliver Services. Customer is responsible for site safety, facility compliance, and ensuring that Openwater's personnel do not interfere with clinical or operational activities.
(c) Clinical/Research Environment. If Services are provided in a clinical, hospital, or research environment, Customer is solely responsible for: (i) obtaining all necessary institutional approvals and consents; (ii) ensuring Openwater's presence complies with facility policies and regulations; (iii) ensuring Openwater personnel are not positioned as clinical supervisors or clinical decision-makers; and (iv) maintaining clinical confidentiality and HIPAA compliance. Openwater's presence at a clinical site does not constitute clinical oversight, clinical decision-making, or assumption of clinical responsibility.
(d) Indemnity for Site-Related Liability. Customer shall indemnify, defend, and hold harmless Openwater from any claims, liabilities, or damages arising from: (i) Customer's site conditions (hazards, compliance violations, unsafe facilities); (ii) injuries to Customer's personnel; (iii) loss or damage to Customer's equipment or facilities; (iv) Customer's use of Services in violation of law, regulation, or institutional policy; or (v) clinical outcomes or regulatory issues arising from Customer's use of the Product or Services.
6. SAFETY AND EFFICACY DATA
6.1 Safety Data. Customer shall promptly notify Openwater in writing of any adverse events, safety concerns, device malfunctions, unanticipated problems, or other safety-related data or findings (collectively, “Safety Data”) arising from or related to the use of the Product, whether or not such events are required to be reported to any regulatory authority. Customer agrees to provide Openwater with all Safety Data generated or obtained in connection with the use of the Product, including, without limitation, any reports submitted to an Institutional Review Board (“IRB”), ethics committee, or regulatory agency. Such notification shall be made as soon as reasonably practicable, but in no event later than ten (10) business days after Customer becomes aware of the Safety Data, except where a shorter timeline is required by law or regulatory authority. Customer shall report such Safety Data to Openwater by completing Openwater’s Safety Data Disclosure Form or by emailing Openwater at safety@openwater.health. Customer shall cooperate with Openwater in investigating any such Safety Data and shall provide additional information or documentation as reasonably requested by Openwater. Customer’s obligations under this section are subject to compliance with applicable laws, IRB requirements, and participant consent agreements.
6.2 Customer acknowledges and agrees that Openwater may use and disclose any Safety Data provided by Customer in connection with the use of the Product for the purposes of improving the Product, fulfilling regulatory obligations, and promoting safe use of the Product. Openwater may share such Safety Data with its other customers in aggregated or de-identified form, provided that Openwater does not disclose any information that would reasonably identify any individual research subject, except as required by law or regulatory authorities. Openwater will not attempt to re-identify any de-identified data.
6.3 Efficacy Data. “Efficacy Data” means all data, results, analyses, and reports generated by Customer in connection with the use of the Product that relate to the Product’s efficacy, performance, or clinical outcomes, including but not limited to raw data, summary reports, statistical analyses, and study protocols.
6.4 Customer may provide Efficacy Data to Openwater in electronic format and in accordance with any reasonable templates or standards provided by Openwater upon completion of the applicable study, and at such other times as reasonably agreed upon by the parties Customer shall ensure that all Efficacy Data shared with Openwater is de-identified in accordance with (i) the HIPAA Privacy Rule’s de-identification standards, (ii) institutional policies, and (iii) participant consent agreements, and does not contain any personally identifiable information or protected health information, unless otherwise agreed in writing and in compliance with applicable law.
6.5 Customer acknowledges and agrees that Openwater may use Efficacy Data for product improvement and other legitimate business purposes, subject to the confidentiality provisions of this Agreement. Openwater may share such Efficacy Data with its other customers solely in aggregated and de-identified form, provided that Openwater does not disclose Customer’s identity or any information that would reasonably identify Customer or any individual research subject, except as required by law or regulatory authorities. Customer retains the right to publish Efficacy Data.
6.6 Data Generated During Services. If Customer participates in Services (Professional Services, Consulting, Data Analysis, etc.) involving analysis or handling of Customer data, the following apply:
(a) De-Identification. Any raw data (patient data, research data, performance data) that Customer provides to Openwater in connection with Services must be de-identified in accordance with HIPAA Privacy Rule standards, institutional policy, and applicable consent agreements. Customer is solely responsible for ensuring de-identification.
(b) Openwater's Use of Aggregate Data. Openwater may use de-identified, aggregated data and methodologies derived from Services for: (i) service improvement and quality assurance; (ii) benchmarking and algorithm development; and (iii) aggregate analytics to improve the Product or Services. Openwater will not identify Customer or any research subject in such uses.
(c) Ownership. Customer retains ownership of its raw research/clinical data. Openwater retains ownership of its methodologies, code, algorithms, and improvements developed during the engagement. See the Services MSA, Section 2.8.5 for IP allocation.
(d) Confidentiality. Any non-published data, code, or analysis provided by Openwater to Customer is confidential and subject to Section 8 (Confidentiality).
7. PAYMENT OF FEES
7.1 Customer will pay Openwater the applicable fees as set forth on the Order Form (the “Fees”). All payments will be made in accordance with the Payment Schedule and the Method of Payment. If not otherwise specified, payments will be due within thirty (30) days of invoice and are nonrefundable.
7.2 Unpaid Fees are subject to a finance charge of one point five percent (1.5%) per month, or the maximum permitted by law, whichever is lower, plus all expenses of collection, including reasonable attorneys’ fees. Fees under this Agreement are exclusive of all tariffs and taxes, including national, state or provincial and local use, sales, value-added, excise, property and similar taxes, if any. Customer agrees to pay such taxes (excluding US taxes based on Openwater’s net income) unless Customer has provided Openwater with a valid exemption certificate. In the case of any withholding requirements, Customer will pay any required withholding itself and will not reduce the amount paid to Customer on account thereof. Customer will pay Openwater the applicable fees for any Services as set forth in the applicable Services Order Form. Unless otherwise specified, payments will be due within thirty (30) days of invoice and are nonrefundable except as expressly provided in the Services MSA.
8. CONFIDENTIALITY
8.1 Each party (the “Receiving Party”) understands that the other party (the “Disclosing Party”) has disclosed or may disclose non-public information relating to the Disclosing Party’s technology or business (hereinafter referred to as “Proprietary Information” of the Disclosing Party).
8.2 The Receiving Party agrees: (i) not to divulge to any third person any such Proprietary Information, (ii) to give access to such Proprietary Information solely to those employees with a need to have access thereto for purposes of this Agreement, and (iii) to take the same security precautions to protect against disclosure or unauthorized use of such Proprietary Information that the party takes with its own proprietary information, but in no event will a party apply less than reasonable precautions to protect such Proprietary Information. The Disclosing Party agrees that the foregoing will not apply with respect to any information that the Receiving Party can document (a) is or becomes generally available to the public without any action by, or involvement of, the Receiving Party, or (b) was in its rightful possession or known by it without restriction prior to receipt from the Disclosing Party, or (c) was rightfully disclosed to it without restriction by a third party, or (d) was independently developed without use of any Proprietary Information of the Disclosing Party. Nothing in this Agreement will prevent the Receiving Party from disclosing the Proprietary Information pursuant to any judicial or governmental order, provided that the Receiving Party gives the Disclosing Party reasonable prior notice of such disclosure to contest such order. In any event, Openwater may aggregate data and use such aggregated data to evaluate and improve the Services and otherwise for its business purposes. Notwithstanding anything to the contrary, if Openwater collects information related to the performance of the Product or Services (including the occurrence of and circumstances relating to any Defect), Openwater may freely use and disclose such information provided it does not identify Customer in doing so. Feedback is Openwater’s Proprietary Information, deemed disclosed by Openwater and to which the exceptions set forth in (b) and (d) above do not apply.
8.3 Customer acknowledges that Openwater does not wish to receive any Proprietary Information from Customer that is not necessary for Openwater to perform its obligations under this Agreement (including its Services obligations), and, unless the parties specifically agree otherwise, Openwater may reasonably presume that any information that is not necessary for Openwater to perform such obligations received from Customer is not confidential or Proprietary Information.
8.4 Services and Professional Confidentiality. If Openwater provides Professional Services, Consulting, or custom development, the following apply:
(a) Openwater may retain and use de-identified methodologies, code libraries, modeling approaches, and learnings from Services for service delivery improvement and aggregate benchmarking.
(b) Customer may retain custom deliverables (code, designs, analyses) provided by Openwater for Customer's own use, subject to applicable open-source license terms (e.g., AGPL).
(c) See the Services MSA, Section 2.8.5 for complete Intellectual Property allocation for Professional Services.
9. TERM; TERMINATION
9.1 Customer’s obligation to purchase the Product becomes effective on the Effective Date.
9.2 In the event of any material breach of this Agreement (including any failure to pay), the non-breaching party may terminate this Agreement by giving thirty (30) days (or ten (10) days in the case of nonpayment) prior written notice to the breaching party; provided, however, that this Agreement will not terminate if the breaching party has cured the breach prior to the expiration of such thirty-day period. Either party may terminate this Agreement, without notice, (i) upon the institution by or against the other party of insolvency, receivership or bankruptcy proceedings, (ii) upon the other party’s making an assignment for the benefit of creditors, or (iii) upon the other party’s dissolution or ceasing to do business.
9.3 Upon termination of this Agreement, Sections 3, 4.3, 5, 6, 7, 8.4, 9, 10, and 11 will survive any such termination.
10. LIMITATION OF LIABILITY
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, (A) IN NO EVENT WILL OPENWATER (OR ANY OF ITS AGENTS, AFFILIATES, LICENSORS OR SUPPLIERS) BE LIABLE FOR ANY INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OF THE PRODUCT OR SERVICES OR ANYTHING ELSE PROVIDED IN CONNECTION WITH THIS AGREEMENT, THE DELAY OR INABILITY TO USE THE PRODUCT OR SERVICES OR ANYTHING ELSE PROVIDED IN CONNECTION WITH THIS AGREEMENT OR OTHERWISE ARISING FROM THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, LOSS OF REVENUE OR ANTICIPATED PROFITS OR LOST BUSINESS OR LOST SALES, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, OR OTHERWISE, EVEN IF OPENWATER (OR ANY OF ITS AGENTS, AFFILIATES, LICENSORS OR SUPPLIERS) HAVE BEEN ADVISED OF THE POSSIBILITY OF DAMAGES, AND (B) THE TOTAL LIABILITY OF OPENWATER HEREUNDER, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR STRICT LIABILITY), OR OTHERWISE, WITH RESPECT TO PRODUT SALES, WILL NOT EXCEED, IN THE AGGREGATE, THE FEES ACTUALLY PAID TO OPENWATER FOR PRODUCTS AND SERVICES IN THE TWELVE MONTH PERIOD PRECEDING THE APPLICABLE CLAIM. THE FOREGOING LIMITATIONS WILL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. (C) IN ADDITION TO THE LIABILITY CAP IN SECTON 10(B), OPENWATER’S LIABILITY FOR ANY CLAIM ARISING FROM THE PROVISION OF SERVICES IS CAPPED SEPARATE AS SET FORTH IN THE SERVICES MSA, SECTION 2.11. THE LIABILITY CAPS IN THIS AGREEMENT AND THE SERVICES MSA ARE CUMULATIVE AND INDEPENDENT.
11. U.S. GOVERNMENT MATTERS
Notwithstanding anything else, Customer may not provide to any person or export or re-export or allow the export or re-export of the Product or Services or any software or anything related thereto or any direct product thereof (collectively “Controlled Subject Matter”), in violation of any restrictions, laws or regulations of the United States Department of Commerce, the United States Department of Treasury Office of Foreign Assets Control, or any other United States or foreign agency or authority. Without limiting the foregoing Customer acknowledges and agrees that the Controlled Subject Matter will not be used or transferred or otherwise exported or re-exported to countries as to which the United States maintains an embargo (collectively, “Embargoed Countries”), or to or by a national or resident thereof, or any person or entity on the U.S. Department of Treasury’s List of Specially Designated Nationals or the U.S. Department of Commerce’s Table of Denial Orders (collectively, “Designated Nationals”). The lists of Embargoed Countries and Designated Nationals are subject to change without notice. Use of the Product or Services is representation and warranty that the user is not located in, under the control of, or a national or resident of an Embargoed Country or Designated National. The Controlled Subject Matter may use or include encryption technology that is subject to licensing requirements under the U.S. Export Administration Regulations. As defined in FAR section 2.101, any software and documentation provided by Openwater are “commercial items” and according to DFAR section 252.227-7014(a)(1) and (5) are deemed to be “commercial computer software” and “commercial computer software documentation.” Consistent with DFAR section 227.7202 and FAR section 12.212, any use modification, reproduction, release, performance, display, or disclosure of such commercial software or commercial software documentation by the U.S. Government will be governed solely by the terms of this Service Agreement or the Services MSA (if applicable) and will be prohibited except to the extent expressly permitted by the terms of this Agreement or the Services MSA.
12. MISCELLANEOUS
If any provision of this Agreement is held invalid or unenforceable, it will be enforced to the maximum extent permitted and the remaining provisions will remain in full force and effect. Neither party may assign this Agreement, whether by operation of law or otherwise, without the prior written consent of the other party, except that either party may assign this Agreement without such consent in connection with a merger, reorganization, or a transfer of more than fifty percent (50%) of its voting securities or assets relating to this Agreement. This Agreement (together with any applicable Order Forms and Exhibits) is the parties’ entire agreement regarding its subject matter and supersedes all prior and contemporaneous understandings; any waiver or amendment must be in a writing signed by both parties. The parties are independent contracting parties and nothing in this Agreement creates an agency, partnership, joint venture, or employment relationship, and Customer has no authority to bind Openwater. In any action to enforce this Agreement, the prevailing party is entitled to recover its reasonable costs and attorneys’ fees. All notices must be in writing and are deemed given upon receipt if delivered personally or by courier, upon electronic confirmation if sent by email, or upon receipt if sent by certified or registered mail, return receipt requested. Openwater is not liable for delays or failures caused by events beyond its reasonable control, including natural disasters, acts of government, war, terrorism, civil unrest, labor disputes (other than those involving its own employees), or failures of utilities, telecommunications, or third-party hosting or network services. This Agreement is governed by the laws of the State of California, U.S.A., without regard to conflict-of-law rules, and the state and federal courts located in San Francisco County, California, have exclusive jurisdiction and venue, provided either party may seek injunctive relief in any court of competent jurisdiction. Customer agrees that Openwater may identify Customer as an Openwater customer in its marketing and communications, subject to any reasonable written branding or attribution guidelines provided by Customer. If Customer purchases Services, the Services MSA (Exhibit B) is incorporated into this Agreement; in the event of conflict regarding Services, the Services MSA controls, and in the event of conflict regarding Products, this Agreement controls. Termination of this Agreement or the Services MSA does not affect provisions expressly stated to survive, including confidentiality, indemnity, intellectual property, and limitation of liability, and either agreement may be terminated without automatically terminating the other unless otherwise stated in the applicable Order Form.
EXHIBIT A
Open-Motion 3.0 Specifications
|
Category |
Parameter |
Value |
|
Product Classification |
Blood flow and hemoglobin concentration meter |
|
|
Configuration |
Major components |
1 console, 1 measurement module, and software |
|
Light Source |
Center Wavelength Peak Power Bandwidth Pulse Length Classification |
795 ± 5 nm 5 Watts < 15 MHz 250 µs Class 1 emissions per IEC 60825 |
|
Detectors |
Type Number Shutter Format Pixel Size Frame Rate |
CMOS 16 Global 1920 x 1280 2.2 µm 40 fps |
|
Terminals and I/O signals |
Electrical Optical DC Power Supply Laser TTL Sync |
3 ⨉ USB-C 2 ⨉ 200 um fiber optics 1 ⨉ Barrel Jack 1 ⨉ SMA |
|
Mechanics |
Dimensions Weight |
W: 250 mm, H: 75 mm, D: 160 mm Approx. 2.5 kg |
|
Software Requirements |
Operating System Memory Storage Connections |
Windows 10, version 22H2 or later or Apple macOS 12 or later 8 GB of RAM 100 GB of free storage 1 available USB-C port (at least USB 3.0) |
|
Others |
Power Supply Power Consumption Operation Environment Storage Environment |
AC 100 - 240V, 50/60 Hz 72 Watts (Maximum) 15°C - 30°C, 20% RH - 80% RH -0°C - 40°C, 20% RH - 80% RH |
|
Compliance |
IEC standards ISO standards |
60601-1, 60825-1, 62304 13485, 10993 |
Open-LIFU 2.0 Specifications1
|
Category |
Parameter |
Value |
|
Sonication Parameters |
Center frequencies Mechanical Index at focus Pulse length Duty Cycle Duration Focusing range (1 module) Focusing range (multi-module) Apodization Focal Patterns |
100-500 kHz 0-1.9 MI 0-100 ms 0-50% 0-15 minutes 3cm (150kHz), 6cm (400kHz) 11cm (deeper may be possible with more modules than 4x2 grid) Binary Singe, Multi (rastered) |
|
Transmit Modules |
Number of Elements Transmit Electronics Center frequencies Footprint Communication Expansion ports Receive Channels |
64 (8x8 grid) per single transducer On-module 150kHz, 400kHz 4x4 cm I2C, TTL I2C Expansion header |
|
Transducers |
Number of transmit modules Connection to console Affixation to body |
Depending on frequency & duty cycle- Use of many transducers simultaneously at max power may require custom power supply - TBD Flexible Cable Multiple strap configurations |
|
Console |
Input Power Output Voltage Output Power Input Communication Port Size |
120V / 240V AC +/- (5-96V) DC 60W Peak USB C 6” x 6” x 2” |
|
Software |
Operating System Memory Storage Connections GPU Simulation Engine Language Components |
Windows 11 or later 8 GB of RAM 100 GB of free storage 1 available USB-C port (at least USB 3.0) NVIDIA Recommended K-Wave (python version) Python 1. Underlying Python Modules. |
|
Transducer Tracking |
Method Accuracy |
3D Scanning TBD – requires < 2mm |
|
Compliance** |
IEC Standards ISO Standards |
60601-1-1, 60601-1-2, 60601-1-6, 60601-2-5, 60601-2-37, 60601-2-62, 62304 13485, 10993 |
1Openwater has not yet been certified for compliance to these standards.
2Preliminary specification for informational purposes only. Subject to change.
Exhibit B
OPENWATER SERVICES AND SUPPORT AGREEMENT
PREAMBLE
This Openwater Services and Support Agreement (the “Services MSA” or “Agreement”) is between Openwater, as defined in the Openwater Product Sale Terms and Conditions (“Product Terms”), and the Customer identified in the applicable Order Form, and is effective as of the effective date stated in that Order Form.
This Agreement governs Openwater’s provision of services to Customer, including Orientation and Training, Support Services (such as virtual technical support and any on-site clinical-technical support), Annual Platform Support and Maintenance (APSM), and Professional Services (such as engineering, consulting, and data analysis).
This Services MSA is supplemental to, and will be interpreted together with, the Product Terms. Capitalized terms used but not defined in this Services MSA have the meanings given in the Product Terms. If there is a direct conflict between this Services MSA and the Product Terms, this Services MSA will control with respect to the Services, and the Product Terms will control with respect to the Products.
ARTICLE 1: GENERAL TERMS FOR ALL SERVICES
1.1 Service Categories and Order Forms. Openwater’s Services generally fall into the following categories, as further described in Article 2:
(a) Orientation and Training: on-site or remote instruction regarding Product setup, operation, safety, and associated software.
(b) Support Services: ongoing technical assistance, including virtual technical support and, where applicable, on-site case-day technical support.
(c) Annual Platform Support and Maintenance (APSM): optional renewable support and maintenance programs for eligible Products.
(d) Professional Services: custom engineering, consulting, study design, data analysis, and related advisory work.
(e) Cloud Services: subscription‑based access to hosted software and processing capabilities, including Openwater Cloud Services for photogrammetry processing and related cloud features, as described in the applicable Order Form and Cloud Services description.
For each order, the specific Services, scope, fees, timing, and any special terms will be set out in the applicable Order Form (and any attached Service Specification or statement of work).
1.2 Standard of Care; No Guaranteed Results. Openwater will perform the Services in a professional and workmanlike manner using commercially reasonable efforts and qualified personnel appropriate to the type of Service. However, the Services do not guarantee any particular result or outcome (including regulatory approvals, clinical or research success, publications, commercial results, or resolution of any particular technical issue), and Openwater does not assume responsibility for Customer’s compliance with laws, regulations, or institutional requirements.
1.3 No Service Level Agreements. Unless the parties enter into a separate written service level agreement or statement of work that expressly sets out service levels, Openwater does not commit to specific response times, resolution times, uptime percentages, or 24/7 availability. For standard Support Services, Openwater will use commercially reasonable efforts to respond during its normal business hours, but actual timing will depend on issue complexity and Customer cooperation.
1.4 Scope Limitations. Unless expressly stated in an Order Form or Service-specific description, the Services do not include: clinical or medical advice or decision-making; regulatory, reimbursement, or IRB/ethics consulting; project management of Customer’s operations; data interpretation or statistical analysis (outside of agreed Professional Services); custom software development beyond the standard Product features; training on Customer’s own systems or unrelated third-party software; or troubleshooting of Customer’s network, facilities, or third-party devices.
1.5 Customer Responsibilities. For all Services, Customer is responsible for: (a) maintaining the Products and following applicable documentation and training; (b) providing timely access to facilities, systems, personnel, and information reasonably necessary for Openwater to perform the Services; (c) ensuring its use of the Products and Services complies with applicable laws, regulations, institutional policies, and ethical standards; and (d) safeguarding any credentials or access granted in connection with the Services and protecting its own confidential information.
1.6 Right to Refuse or Suspend Services. Openwater may refuse, suspend, or terminate some or all Services, in whole or in part, if Customer materially breaches this Services MSA, the Product Sale Terms and Conditions, or an applicable Order Form (including for non-payment), if Customer requests that the Services be used in a manner that Openwater reasonably believes is illegal, unsafe, or unethical, or if Customer fails to provide necessary access or cooperation. Where practicable, Openwater will provide written notice and a reasonable opportunity to cure before suspending or terminating Services.
ARTICLE 2: SPECIFIC SERVICE DESCRIPTIONS
2.1 Orientation and Training.
2.1.1 Service Description. Orientation and Training may include initial setup and basic configuration of the Product, hands-on instruction on operation and safety, overview of associated software and basic troubleshooting, and high-level use-case discussion. Sessions are typically delivered in a single block of up to approximately four hours, either on-site or remotely, as agreed in the Order Form and subject to personnel availability.
2.1.2 On-Site Orientation. Where Orientation is performed at Customer’s site, Customer is responsible for: (a) providing a safe, compliant environment and disclosing any material hazards in advance; (b) ensuring necessary space, power, and infrastructure are available and functioning; and (c) ensuring that Openwater’s presence and activities comply with facility safety, credentialing, infection control, and privacy requirements, including obtaining any required patient or research consents. Openwater personnel attend solely to deliver technical training and do not provide clinical services or assume clinical responsibility.
2.1.3 Remote Orientation. Where Orientation is performed remotely, Customer will provide: (a) a stable internet connection and suitable video-conferencing capability; (b) a designated technical lead available for the full session; and (c) access to the Product and related systems so that training can be conducted via screen-share and remote walkthrough. Openwater will provide the remote meeting link, and Customer is responsible for any necessary internal approvals to use the chosen platform.
2.1.4 Fees and Changes. Fees and any specific cancellation or rescheduling terms for Orientation (including notice periods, partial refunds, and treatment of non-refundable travel) will be as set forth in the applicable Order Form or Service description and will govern with respect to Orientation. Unless otherwise stated, Orientation fees are invoiced and payable under Article 5.
2.1.5 Training Documentation. Following completion of Orientation, Openwater may provide Customer with a record or certificate noting the date, general topics covered, and attendees. Any such documentation confirms only that training was delivered and does not certify competence, qualification, or licensure to operate the Product.
2.2 Support Services
2.2.1 Virtual Technical Support. Virtual Technical Support consists of remote technical assistance via email, phone, or video conference relating to installation, configuration, and operation of the Products, as well as basic troubleshooting and diagnostics. Support does not include clinical decision-making or medical advice, detailed data analysis, regulatory or compliance consulting, or troubleshooting of Customer’s broader IT infrastructure or third-party systems, except as specifically agreed in writing. Support is generally billed on an hourly, time-and-materials basis as set out in the applicable Order Form.
2.2.2 Clinical-Technical Case-Day Support. Clinical-Technical Support consists of on-site technical presence in connection with a clinical case, treatment, research session, or similar procedure, focused on device readiness, basic technical monitoring, and post-case technical follow-up. The scope does not include clinical protocol design or review, clinical guidance, or any form of medical practice or patient care. Customer remains solely responsible for clinical decisions, patient safety, and regulatory and institutional compliance. Fees, scheduling requirements, and any special cancellation terms for case-day support will be specified in the applicable Order Form.
2.2.3 Support Exclusions. Support Services do not cover issues arising from: (a) use of the Products contrary to documentation, training, or specifications; (b) Customer’s network, power, or facility conditions; (c) third-party hardware or software not supplied by Openwater; (d) custom configurations that Openwater has not approved; or (e) regulatory, IRB, or institutional compliance questions. Where an issue falls outside the scope of Support, Openwater may propose Professional Services under Section 2.4.
2.3 Annual Platform Support and Maintenance (APSM)
2.3.1 Overview. APSM is an optional, renewable annual program that provides post-warranty support and maintenance for eligible Products, as further described in the applicable APSM Order Form. APSM typically begins after expiration of the standard Product warranty and continues for one-year terms, subject to renewal or non-renewal as stated in the Order Form.
2.3.2 Included Services. During an active APSM term, Openwater will provide the covered services described in the APSM materials or Order Form, which may include a defined level of technical support, access to certain software updates and bug fixes, and specified repair or replacement coverage for qualifying hardware issues within normal use parameters. Any annual support-hour allotments, discounts, or other program benefits will be as set forth in the APSM description and may be subject to stated limits, exclusions, and tracking.
2.3.3 Exclusions, Renewal, and Termination. APSM does not cover damage or issues caused by misuse, unauthorized modification, environmental conditions outside specifications, or third-party systems, nor does it provide guaranteed uptime or outcome. Renewal, non-renewal, termination rights, and any program-specific refund or proration rules for APSM will be as set forth in the applicable Order Form or Service description, and are subject to the general payment and termination provisions of Articles 5 and 10. If APSM is not in effect, Openwater may still provide support on a standalone basis under Support or Professional Services at then-current rates.
2.4 Professional Services
2.4.1 Scope. Professional Services may include custom engineering, software development or configuration, integration work, data analysis, statistical or methodological consulting, documentation support (for example, protocols, grant or manuscript support), and related advisory services, as described in the applicable Order Form. The specific scope, deliverables, assumptions, timelines, and responsibilities will be defined in the corresponding statement of work or Service description.
2.4.2 Engagement and Fees. Professional Services are typically scoped through an initial consultation, followed by a written proposal or Order Form that specifies whether the engagement is fixed-price or time-and-materials (with any caps or milestones). Work begins only after written authorization by Customer. Fees, minimums, and any travel and expense reimbursement will be as stated in the Order Form and are payable under Article 5.
2.4.3 Standard of Care and Limitations. Openwater will perform Professional Services in a professional and workmanlike manner using commercially reasonable efforts, but does not guarantee any particular outcome, including regulatory approval, publication, statistical significance, or commercial success. Customer is responsible for evaluating deliverables and determining their suitability for Customer’s intended use. Intellectual property and confidentiality for Professional Services are governed by Articles 6 and 7.
2.5 Cloud Services
2.5.1 Description. Cloud Services consist of cloud‑hosted software and processing capabilities made available by Openwater on a subscription basis, including Openwater Cloud Services for photogrammetry processing that interoperates with the Openwater Photogrammetry app and Open‑LIFU system to assist with 3D reconstruction and spatial registration workflows, as further described in the applicable Order Form and documentation. Customers may continue to use any local, laptop‑based reconstruction tools provided with the Products at no additional charge; the Cloud Services subscription specifically enables cloud‑accelerated processing and associated workflow enhancements.
2.5.2 Subscription; Users; Usage. Unless otherwise stated in the Order Form, Cloud Services are licensed on an annual subscription basis, for the number of named or concurrent users and up to the included number of successful reconstructions or similar processing units per subscription period specified in the Order Form. Customer will not allow more users to access the Cloud Services than the quantity specified, and will not exceed any stated usage limits, except as Openwater may agree in writing (which may include overage fees at Openwater’s then‑current rates).
2.5.3 License and Restrictions. Subject to this Services MSA and timely payment of applicable fees, Openwater grants Customer a limited, non‑exclusive, non‑transferable, non‑sublicensable right, during the applicable subscription term, to access and use the Cloud Services solely for Customer’s internal research and educational purposes in connection with Customer’s lawful use of the Products. For clarity, “Cloud Services” means the hosted, server‑side software and processing environment operated by Openwater, and does not include any client‑side or other software made available under separate open‑source licenses.
Customer will not (i) use the Cloud Services for time‑sharing or service bureau purposes or to provide services to third parties, (ii) copy, modify, or create derivative works of the Cloud Services, (iii) reverse engineer or attempt to obtain the source code of the Cloud Services except to the limited extent permitted by law, or (iv) circumvent or attempt to circumvent any access controls or usage limits. Any open‑source software provided by Openwater in connection with the Products or Services, including any photogrammetry application made available on GitHub, is licensed separately under its applicable open‑source license terms (for example, AGPL), and Customer’s rights and obligations with respect to such open‑source components are governed solely by those licenses.
2.5.4 Research‑Only Use; No Clinical Use. The Openwater Photogrammetry app and Cloud Services are intended for research and educational use in conjunction with Open‑LIFU to assist with 3D reconstruction and spatial registration of head and device geometry. They are not cleared or approved by the U.S. Food and Drug Administration or any other regulatory authority, are not intended for diagnosis or treatment of any disease or condition, and must not be used as a standalone basis for clinical decision‑making or patient care. Customer is solely responsible for ensuring that its use of the Cloud Services complies with applicable research, regulatory, and institutional requirements.
2.5.5 Availability; No SLA. Cloud Services are provided on an “as available” basis and may be subject to scheduled maintenance or unscheduled downtime. Unless the parties enter into a separate written service level agreement that expressly applies to the Cloud Services, Openwater does not guarantee any particular uptime, response time, or processing turnaround for Cloud Services.
2.5.6 Data Transfer, Security, and Retention. Customer authorizes Openwater to receive, store, process, and transmit imaging and related data submitted to the Cloud Services as necessary to provide the Cloud Services and maintain the underlying platform. Openwater will use encrypted connections for data transfers to and from the Cloud Services and will implement reasonable technical and organizational measures designed to protect such data while in Openwater’s control, consistent with Section 6 (Confidentiality and Data Handling). Unless otherwise agreed in writing, Openwater does not retain imaging data or personally identifiable information in the Cloud Services after processing is complete, except for transient caching, routine backup, and limited retention as reasonably necessary to operate, secure, and trouble shoot the platform.
2.5.7 Customer Data Responsibilities. Customer is responsible for ensuring that any data provided to the Cloud Services is collected and used in compliance with applicable laws, institutional policies, and research approvals, and, where applicable, is de‑identified in accordance with Section 6.2. Customer will not intentionally upload protected health information or personally identifiable information unless the parties have entered into an appropriate written agreement permitting such disclosure.
ARTICLE 3: ON-SITE SERVICES TERMS
This Article 3 applies whenever Openwater personnel perform Services at Customer’s facilities or other locations designated by Customer.
3.1 Site Safety Responsibilities
(a) Customer Responsibilities. Customer is solely responsible for the safety and compliance of its facilities, operations, and personnel. Without limiting the foregoing, Customer will: (i) disclose to Openwater any known material environmental, occupational, health, or safety hazards at the site in advance of the visit; (ii) ensure the site complies with applicable health and safety laws and regulations; and (iii) provide Openwater personnel with safe access, adequate workspace, and appropriate environmental conditions (including power, lighting, and ventilation). If Openwater reasonably determines that conditions are unsafe or materially different from those disclosed, Openwater may suspend or terminate the on-site Services without liability.
(b) Clinical and Research Environments. Where Services occur in clinical or research settings, Customer is responsible for ensuring that Openwater’s presence and activities comply with facility policies, infection control, credentialing, privacy, and confidentiality requirements, and that Openwater personnel do not interfere with patient care or research protocols. Openwater personnel will not enter sterile fields or treatment areas or access protected health information except as expressly permitted and appropriately authorized in writing.
(c) Openwater Responsibilities. While on site, Openwater will follow Customer’s reasonable written safety rules provided in advance (and not inconsistent with Openwater policies or law), take reasonable precautions with respect to disclosed hazards, use appropriate personal protective equipment where required, and promptly alert Customer to any material unsafe condition observed. Openwater does not assume general responsibility for site safety, facility operations, or clinical care.
3.2 Insurance and Risk Allocation
(a) Customer Insurance. Customer will maintain, at its own expense and throughout the period of on-site Services, (i) commercial general liability insurance covering its facilities and operations, (ii) workers’ compensation as required by law, and (iii) if applicable, professional liability (malpractice) coverage for clinical or research activities. Such policies will be in commercially reasonable amounts for Customer’s industry and operations. Customer’s insurance is primary for losses relating to Customer’s facilities, operations, personnel, and patients or research subjects.
(b) Openwater Insurance. Openwater will maintain commercially reasonable insurance coverage for its own operations and personnel, as required by law and consistent with its role as a technical service provider. Openwater’s insurance does not insure Customer’s facilities, operations, or personnel.
(c) Waiver of Certain Claims. To the fullest extent permitted by law, each party waives claims against the other party for property damage and bodily injury arising solely from ordinary negligence in connection with on-site Services, except to the extent arising from the other party’s gross negligence, willful misconduct, or intentional wrongdoing. This waiver does not limit any insurance coverage required under this Services MSA.
(d) Indemnity by Customer. Customer will indemnify, defend, and hold harmless Openwater and its officers, employees, and agents from third-party claims, damages, losses, and expenses (including reasonable attorneys’ fees) to the extent arising out of: (i) Customer’s facilities, operations, or site conditions; (ii) injuries to Customer’s personnel, patients, or research subjects; (iii) Customer’s use or misuse of the Products or Services, including clinical decisions and outcomes; or (iv) Customer’s failure to comply with applicable law, institutional requirements, or this Services MSA, in each case except to the extent caused by Openwater’s gross negligence or willful misconduct.
(e) Indemnity by Openwater. Openwater will indemnify, defend, and hold harmless Customer from third-party claims to the extent directly arising from Openwater’s gross negligence, willful misconduct, or knowing violation of applicable law in performing the Services.
3.3 Travel and Expense Reimbursement. Where the applicable Order Form provides for reimbursement of travel or out-of-pocket expenses, Customer will reimburse Openwater for reasonable, documented travel and living expenses incurred in providing on-site Services, including transportation, lodging, meals, and necessary incidentals, in accordance with any limits or pre-approval requirements stated in the Order Form. Expenses will be itemized on an invoice and payable under the payment terms in Article 5.
3.4 Scheduling, Cancellation, and Changes
(a) Scheduling. On-site Services will be scheduled by mutual agreement, subject to Openwater personnel availability. Customer will provide written confirmation of the agreed date(s), location, and high-level scope within a reasonable period before the visit, as specified in the applicable Service description or Order Form.
(b) Cancellation and Rescheduling. Any specific cancellation or rescheduling terms (including notice periods, fees, and treatment of non-refundable travel) for Orientation, Clinical-Technical Support, or other on-site Services will be as set forth in the applicable Service description or Order Form and will govern with respect to those Services.
3.5 Recording and Case Studies. Openwater may, with Customer’s prior consent and subject to applicable privacy and confidentiality requirements, make limited recordings, photographs, or notes during on-site Services for internal quality assurance, training, or technical reference. Openwater will not intentionally record or retain protected health information or personally identifiable information without an appropriate written agreement and Customer’s approvals. Any use of de-identified images or descriptions of the engagement in marketing or case studies will be subject to Customer’s prior written consent, which Customer may grant or withhold in its discretion.
ARTICLE 4: SUPPORT HOURS, HOLIDAYS, AND AVAILABILITY
4.1 Standard Support Hours. Unless otherwise stated in an Order Form, Openwater will make Support Services available during its standard business hours of 9:00 a.m. to 5:00 p.m. Pacific Time, Monday through Friday, excluding U.S. federal holidays.
4.2 Response Expectations (No SLA). Openwater will use commercially reasonable efforts to acknowledge support requests received during standard support hours relating to the Services, including Cloud Services, within one business day. Actual response and resolution times may vary depending on the nature and complexity of the issue and Customer’s cooperation. Unless the parties enter into a separate written service level agreement, Openwater does not guarantee any specific response time, resolution time, uptime level, or service availability metric.
4.3 After-Hours and Premium Support. If Customer requires support outside standard support hours (including evening, weekend, holiday, or 24/7 coverage), Customer may request such services in writing. Any after-hours or premium support is subject to Openwater’s prior approval, availability, and a separate quote or Order Form, and is not included in standard Support Services or APSM unless expressly stated.
ARTICLE 5: BILLING AND PAYMENT
5.1 Invoicing. Openwater will invoice Customer for the Services as specified in the applicable Order Form. Invoices may be delivered electronically (including by email) and will state the Services provided, dates of Service, applicable rates or fees, any approved travel and expenses, and the applicable payment due date, together with remittance instructions.
5.2 Payment Terms. Unless otherwise stated in the applicable Order Form:
(a) Timing. Invoices are due and payable within 30 days of the invoice date (Net 30). Certain Services may specify different timing (for example, due upon invoice for specific clinical-technical engagements or annual APSM fees), and any such terms stated in the Order Form or Service description will control.
(b) Methods. Customer may pay by ACH transfer (preferred), check, or credit card. Openwater may charge a reasonable processing fee for credit card payments, as specified on the invoice or in the Order Form.
(c) Application of Payments. Openwater may apply payments received to the oldest outstanding undisputed invoices first, unless Customer clearly identifies a different allocation at the time of payment.
5.3 Late Payments
(a) Finance Charges. Any undisputed amount not received by the due date may accrue interest at 1.5% per month (or the maximum rate permitted by applicable law, if lower) from the due date until paid.
(b) Suspension and Termination. If any undisputed amount remains unpaid more than 15 days after the due date, Openwater may, after notice to Customer: (i) suspend some or all ongoing Services (including Support or APSM benefits); (ii) require prepayment or other assurances for future Services; and/or (iii) exercise its termination rights under Article 10.
(c) Collection Costs. Customer will reimburse Openwater for reasonable costs and expenses (including reasonable attorneys’ fees and court costs) incurred to collect undisputed overdue amounts, except to the extent the overdue amounts are caused by Openwater’s billing error.
5.4 Taxes. Fees for the Services are exclusive of sales, use, value-added, excise, and other similar taxes. Customer is responsible for all such taxes associated with the Services (excluding taxes based on Openwater’s income), unless Customer provides a valid exemption certificate. Openwater may invoice applicable taxes as a separate line item.
5.5 Refunds and Cancellations. Except as expressly stated in this Services MSA or an applicable Order Form, fees for the Services are non-refundable. Any specific cancellation or refund terms for a Service (for example, Orientation, Clinical-Technical Support, APSM, or Professional Services) will be as set forth in the applicable Order Form or Service description and will govern with respect to that Service. Nothing in this Section limits any remedy that cannot be disclaimed or limited under applicable law.
ARTICLE 6: CONFIDENTIALITY AND DATA HANDLING
6.1 Confidentiality. During the Services, each party may disclose to the other confidential or proprietary information, including technical, clinical, business, and research information. Each party will protect the other party’s confidential information in accordance with the confidentiality provisions of the Product Sale Terms and Conditions and will use such information only as necessary to perform or receive the Services.
6.2 Customer Data
(a) De-Identification and Approvals. If Customer provides research data, clinical data, or other proprietary data to Openwater in connection with the Services, Customer is responsible for ensuring that such data: (i) has been de-identified in accordance with applicable privacy laws and institutional policies (including, where applicable, HIPAA de-identification standards); (ii) is provided in compliance with Customer’s institutional data governance requirements; and (iii) is covered by any required IRB or research oversight approvals and participant consents. Customer will not provide Openwater with personally identifiable information or protected health information unless the parties have entered into an appropriate written agreement permitting such disclosure.
(b) Security. Openwater will implement and maintain reasonable technical and organizational measures designed to protect Customer data used in the Services, including encrypted transmission where appropriate, secure storage, and limiting access to personnel with a need to know for the relevant engagement.
(c) Retention and Deletion. Unless otherwise agreed in writing, Openwater will retain Customer data only for so long as reasonably necessary to perform the Services and to address any follow-up questions. Upon Customer’s written request, and subject to legal and regulatory retention requirements and routine backup practices, Openwater will delete or de-identify Customer data used solely for the Services.
6.3 Use of De-Identified and Aggregate Information. Openwater may use de-identified, anonymized, or aggregated information derived from the Services and from Customer data (once de-identified or aggregated) to operate, maintain, and improve its products and services, to develop and validate algorithms and methodologies, to perform internal analytics and benchmarking, and to train Openwater personnel. In doing so, Openwater will not intentionally identify Customer or any individual or disclose Customer’s confidential information.
6.4 Work Product Confidentiality. Reports, analyses, code, configurations, and other deliverables provided to Customer in connection with the Services are deemed Openwater confidential information, subject to the confidentiality provisions in the Product Sale Terms and Conditions, except to the extent the parties expressly agree otherwise in an Order Form or separate writing. Customer will protect such deliverables from unauthorized disclosure and will not provide them to third parties except as permitted under this Services MSA, an applicable license, or as required by law or regulation.
ARTICLE 7: INTELLECTUAL PROPERTY
This Article 7 applies to Services and any related deliverables and supplements the intellectual property provisions in the Product Sale Terms and Conditions.
7.1 Custom Deliverables
(a) Openwater Ownership. As between the parties, Openwater owns all rights, title, and interest in and to any software, code, designs, analyses, documentation, reports, models, methodologies, workflows, templates, and other materials created, developed, or delivered by Openwater in connection with the Services, including all underlying algorithms, methods, code libraries, utilities, know-how, and any improvements or enhancements to Openwater’s pre-existing technology.
(b) Customer License. Subject to Customer’s timely payment of applicable fees, Openwater grants Customer a perpetual, non-exclusive, non-transferable license to use the specific deliverables provided to Customer under the applicable Professional Services engagement solely for Customer’s internal research and development purposes, in connection with Customer’s lawful use of the Products. Customer may modify such deliverables for its internal use but may not sell, sublicense, distribute, or otherwise make them available to any third party without Openwater’s prior written consent.
7.2 Pre-Existing and Open-Source Materials. Openwater retains all rights, title, and interest in and to any software, tools, templates, libraries, documentation, and methodologies that existed prior to the Services or that are developed independently of the Services. If any deliverables include or depend on such pre-existing Openwater materials, or on open-source components, those elements are licensed (and may be used) only in accordance with the applicable proprietary or open-source license terms (for example, AGPL), and Customer agrees to comply with all such license obligations.
7.3 Feedback and Improvements. If Customer provides suggestions, enhancement requests, recommendations, bug reports, or other feedback relating to the Products or Services, Openwater may use and incorporate that feedback without restriction and without obligation or compensation to Customer. To the extent necessary, Customer hereby assigns to Openwater all right, title, and interest in and to such feedback.
7.4 Publication and Attribution. If work performed under Professional Services contributes to research, analyses, or findings that Customer intends to publish:
(a) Customer Publication. Customer retains the right to publish its own research and results, subject to protecting Openwater’s confidential information and any applicable restrictions in this Services MSA and the Product Sale Terms and Conditions.
(b) Review and Confidentiality. At Openwater’s request, Customer will provide a draft of any proposed publication that materially describes the Services or Openwater’s technology at least 30 days before submission, to allow Openwater to review for protection of its confidential information and correction of technical inaccuracies.
(c) Attribution and Use by Openwater. Where appropriate and mutually agreed, Customer will acknowledge Openwater’s contribution (for example, by noting that “technical services were provided by Openwater”). Subject to Customer’s confidentiality requirements and any agreed attribution terms, Openwater may reference the engagement and any resulting publications in its marketing materials, case studies, presentations, and grant or regulatory submissions, either with Customer’s name or in de-identified form.
ARTICLE 8: LIMITATION OF LIABILITY FOR SERVICES
This Article 8 applies to the Services and supplements, and does not replace, the limitation of liability provisions in the Product Sale Terms and Conditions.
8.1 Disclaimer of Warranties for Services. The Services are provided “AS IS” and “AS AVAILABLE.” Openwater makes no warranties, express or implied, regarding the Services, including any warranty that the Services will be uninterrupted, error-free, or achieve any particular result or outcome. To the fullest extent permitted by law, Openwater disclaims all implied warranties, including implied warranties of merchantability, fitness for a particular purpose, title, and non-infringement.
8.2 Cap on Liability for Services. To the fullest extent permitted by law, Openwater’s total aggregate liability arising out of or relating to the Services under this Services MSA, whether in contract, tort, or otherwise, is limited to the fees actually paid by Customer to Openwater for the specific Service giving rise to the claim during the 12-month period immediately preceding the event giving rise to the claim. If multiple claims relate to the same Service, this cap applies in the aggregate to all such claims.
8.3 Excluded Damages. In no event will Openwater be liable for any: (a) indirect, incidental, special, consequential, exemplary, or punitive damages; (b) loss of revenue, profits, goodwill, or business opportunities; (c) loss or corruption of data; (d) cost of substitute goods or services; or (e) other non-direct economic loss, in each case arising out of or relating to the Services, even if Openwater has been advised of the possibility of such damages or such damages were otherwise foreseeable.
Without limiting the foregoing, Openwater is not liable for any damages arising solely from: (i) a failure of the Services to resolve a technical issue; (ii) Professional Services not achieving Customer’s desired outcome, regulatory approval, publication, or commercial success; (iii) data analysis not revealing expected patterns or insights; or (iv) denial, delay, or failure of regulatory or institutional approvals.
8.4 Mitigation. Customer will take reasonable steps to mitigate losses and damages relating to any issue with the Services, including cooperating with Openwater’s reasonable requests to investigate, troubleshoot, and implement workarounds, and promptly escalating material issues rather than delaying notice. To the extent Customer fails to take reasonable mitigation steps, Openwater’s liability will be reduced accordingly.
8.5 Relationship to Product Limitations. The limitations and exclusions in this Article 8 apply to claims arising from or relating to the Services. Limitations and exclusions for claims arising from or relating to the Products are set out in Section 10 of the Product Sale Terms and Conditions. For clarity, the liability cap for Services under this Services MSA is separate from, and in addition to, any liability cap that applies to the Products under the Product Sale Terms and Conditions.
ARTICLE 9: RESTRICTIONS AND RESPONSIBILITIES
9.1 Customer Use of Services. Customer agrees that:
(a) Legal and Regulatory Compliance. Customer will use the Services only in compliance with applicable laws, regulations, institutional policies, and ethical guidelines. Customer is solely responsible for obtaining any required regulatory approvals, IRB approvals, informed consent, or institutional authorizations for its intended use of the Products and Services. Openwater does not provide legal, regulatory, ethical, or compliance advice.
(b) No Clinical Services. The Services, including any on-site support, do not constitute clinical services, clinical consultation, or the practice of medicine. Openwater is not a healthcare provider and does not assume any clinical responsibility. Customer remains solely responsible for all clinical decision-making, patient safety, and clinical outcomes.
(c) No Guarantee of Results. The Services do not guarantee any particular result or outcome, including regulatory approval, publication, or commercial success. Customer assumes all risk of project outcomes and unsuccessful results.
(d) Prohibited Uses. Customer will not: (i) use the Services for any illegal, unethical, or harmful purpose; (ii) use the Services to support false or misleading claims about the Products; (iii) use the Services in a way that infringes or misappropriates any third party’s intellectual property or other rights; or (iv) resell, sublicense, or otherwise provide the Services to any third party without Openwater’s prior written consent.
9.2 Customer Cooperation. Customer will:
(a) Information and Access. Provide complete and accurate information reasonably needed for the performance of the Services; provide timely access to relevant facilities, equipment, systems, data, and personnel; and disclose any known issues, hazards, or constraints that may affect the Services.
(b) Product Maintenance. Maintain the Products used in connection with the Services in good working order, including proper power, cooling, and general care; apply Openwater-provided software updates and patches within a reasonable time; and follow Openwater’s operating and maintenance procedures.
(c) Communication and Scheduling. Respond promptly to reasonable inquiries and requests from Openwater related to the Services; confirm scheduled Services in advance as reasonably requested (for example, at least 5 business days before on-site visits); and promptly communicate any changes or cancellations in accordance with the applicable cancellation terms.
(d) License Compliance. Comply with all terms of applicable open-source licenses (including any AGPL or similar licenses) for open-source components included in the Products or any custom deliverables, and comply with all applicable proprietary software license terms provided or referenced by Openwater.
9.3 Openwater’s Right to Refuse or Suspend Services. Openwater may refuse to provide, suspend, or terminate some or all of the Services, in whole or in part, upon written notice to Customer if:
(a) Breach of Agreement. Customer materially breaches this Services MSA, the Product Sale Terms and Conditions, or an applicable Order Form (including for non-payment, unauthorized use, or failure to comply with restrictions) and does not cure the breach within any applicable cure period.
(b) Safety, Legal, or Rights Risk. Openwater reasonably determines that providing or continuing the Services would create an unacceptable safety risk, legal or regulatory risk, or risk of violation of third-party rights, or that Customer’s intended use is illegal, unethical, or otherwise inconsistent with this Services MSA.
(c) Insufficient Cooperation or Misrepresentation. Customer fails to provide required information, access, or cooperation in a timely manner, or materially misrepresents information relevant to the engagement, such that Openwater cannot reasonably or safely perform the Services.
(d) Facility or Credential Issues. For on-site Services, Customer’s facilities, site conditions, or credentialing/clearance requirements prevent the Services from being performed safely, lawfully, or in accordance with Openwater’s policies. Where practicable, Openwater will provide prior written notice of suspension or termination and, if appropriate in Openwater’s reasonable judgment, an opportunity of up to 10 days to cure the underlying issue.
ARTICLE 10: TERM AND TERMINATION
10.1 Term. This Services MSA becomes effective on the effective date of the applicable Order Form (the “Effective Date”) and remains in effect for so long as any Services under an Order Form are being performed, unless terminated earlier under this Article 10.
10.2 Service Duration.
(a) One-time Services (including Orientation, Professional Services, and single-incident support) continue until completion of the applicable Services and payment of all related fees.
(b) Recurring Services. Recurring Services, including APSM, Cloud Services subscriptions, and any support retainer or other subscription-based Service, commence on the start date stated in the applicable Order Form and continue for the initial term specified therein (typically one year), and thereafter automatically renew for successive one-year renewal terms at the then-current subscription quantity and fees, unless not renewed or terminated under this Article 10.
10.3 Termination by Customer.
(a) One-time Services. Customer may cancel one-time Services in accordance with the cancellation and refund terms specified for that Service in this Services MSA and/or the applicable Order Form. Any stated cancellation fees and refund limitations apply.
(b) Recurring Services (including Cloud Services). Customer may elect not to renew any recurring Service, including any Cloud Services subscription or APSM program, by providing at least thirty (30) days’ prior written notice before the end of the then-current term, with non-renewal effective as of the next renewal date. Fees for any partially elapsed term are non-refundable unless expressly stated otherwise in this Services MSA or the applicable Order Form.
(c) Suspension or Reduction. Where expressly permitted in the applicable Order Form, Customer may request suspension or reduction of certain recurring Services with at least 30 days’ prior written notice and may request resumption with at least 5 business days’ prior written notice. Any suspension, reduction, or resumption is subject to Openwater’s confirmation and any applicable fees or adjustments specified in the Order Form.
10.4 Termination by Openwater. Openwater may terminate some or all Services, or this Services MSA, in whole or in part, immediately upon written notice if:
(a) Material Breach. Customer materially breaches this Services MSA or the applicable Order Form and fails to cure the breach within 10 days after written notice describing the breach.
(b) Non-Payment. Any undisputed amount due under this Services MSA or an applicable Order Form remains unpaid more than 15 days after the due date.
(c) Safety or Legal Risk. Openwater reasonably determines that providing or continuing Services would create an unacceptable safety risk, regulatory or legal exposure, or involve an illegal or unethical use.
(d) Facility or Access Issues. For on-site Services, Openwater reasonably determines that Customer’s facilities, site access, or credentialing requirements prevent the Services from being performed safely or in compliance with applicable law or industry standards.
Where practicable, Openwater will provide advance written notice of termination and may, but is not obligated to, work with Customer to identify alternatives that mitigate the underlying issue.
10.5 Effect of Termination; Survival
(a) Cessation of Services and Fees. Upon termination or non-renewal of specific Services, Openwater will cease providing those Services, and Customer will no longer receive related benefits such as ongoing support, discounts, or maintenance coverage. Customer remains responsible for all fees accrued for Services performed up to the effective date of termination and any applicable cancellation fees.
(b) Return or Destruction of Materials. Upon written request by a party made within 30 days after termination of the relevant Services, the receiving party will return or securely destroy the requesting party’s confidential information in its possession or control, except for information retained in backup or archival systems maintained under customary retention policies or as required by law or regulation.
(c) Surviving Provisions. The following provisions survive termination or expiration of this Services MSA or any Order Form: Article 6 (Confidentiality and Data Handling), Article 7 (Intellectual Property), Article 8 (Limitation of Liability), Section 9.3 (Restrictions and Responsibilities), Article 11 (Miscellaneous), any payment, indemnity, and refund obligations that by their nature relate to periods prior to termination, and any other provisions that by their nature are intended to survive.
ARTICLE 11: MISCELLANEOUS
11.1 Entire Agreement. This Services MSA, together with the Product Sale Terms and Conditions and the applicable Order Form, is the entire agreement between the parties regarding the Services and supersedes all prior discussions and understandings about the Services.
11.2 Amendments. Any change to this Services MSA must be in writing and agreed by authorized representatives of both parties, including by electronic signature or clear email confirmation.
11.3 Assignment. Customer may not assign this Services MSA, by operation of law or otherwise, without Openwater’s prior written consent. Openwater may assign this Services MSA to an affiliate or successor without Customer’s consent. Any non-permitted assignment is void.
11.4 Governing Law and Venue. This Services MSA is governed by the same law, and subject to the same exclusive venue and jurisdiction, specified in the Product Sale Terms and Conditions. If those terms do not specify governing law and venue, this Services MSA is governed by California law and the parties submit to the exclusive jurisdiction of the state and federal courts in San Francisco County, California.
11.5 Notices. Notices under this Services MSA must be in writing and are deemed given when delivered personally, sent by confirmed email, or received by certified mail or reputable courier at the addresses below (or as later updated in writing).
For Openwater:
Openwater
733 Front Street, Suite C1A
San Francisco, CA 94111
Email: services@openwater.health
For Customer: As stated in the applicable Order Form.
11.6 Severability; Waiver. If any provision of this Services MSA is unenforceable, it will be enforced to the maximum extent permitted and the remainder will remain in effect. A failure to enforce any provision is not a waiver of that provision or any other provision.
11.7 Third-Party Beneficiaries; Relationship. This Services MSA creates rights only between Openwater and Customer and not for any third party. The parties are independent contractors and not partners, joint venturers, agents, or employees of one another.
11.8 Marketing and Use of Information. Unless Customer opts out in writing, Openwater may identify Customer by name and logo as a customer in customary marketing materials and may use de-identified or aggregated data and feedback from the Services to improve and demonstrate Openwater’s offerings.
11.9 Force Majeure. Openwater is not liable for delay or failure to perform caused by events beyond its reasonable control, including natural disasters, pandemics, governmental actions, war, terrorism, civil unrest, labor issues (other than with its own employees), utility or internet failures, or failures of third-party services, provided Openwater uses reasonable efforts to resume performance.
11.10 Relationship to Product Sale Terms. This Services MSA supplements and is incorporated into the Product Sale Terms and Conditions. If there is a direct conflict: (a) for matters relating to the Services, this Services MSA controls; and (b) for matters relating to Products (including Product warranties, Product IP, Product data, and Product-related limitations of liability), the Product Sale Terms and Conditions control.
Exhibit C
Open-LIFU: Research Use Only Disclaimer
Open‑LIFU is provided for Research Use Only. It is not cleared or approved by the FDA or any other regulatory authority for diagnosis, prevention, or treatment of disease, is not intended for clinical decision-making or patient management, and may not be used for routine clinical care or billed clinical services. Open‑LIFU may be used in non-clinical research, including benchtop, phantom, or animal studies, and may only be used on human subjects in research settings that meet applicable legal and ethical requirements or where expressly permitted under applicable law.
If Customer uses Open‑LIFU in research involving human subjects, Customer represents and agrees that:
- All human‑subject use will be conducted only under an active, approved IRB/ethics (or equivalent) protocol, with valid informed consent and subject protections as required by applicable law and institutional policy.
- Open‑LIFU will be used solely for research purposes as described in such protocol and will not be used or represented as a clinically approved device or as a substitute for standard‑of‑care procedures.
- Open‑LIFU will be operated only by personnel who have received appropriate training and are qualified under Customer’s institutional policies, under the supervision of a responsible investigator.
- Customer will comply with all applicable laws, regulations, and institutional requirements governing human‑subject research and the use of Research Use Only medical devices, including safety monitoring and required reporting.
- Customer is responsible for ensuring that any subject data are handled in compliance with applicable privacy, data protection, and security requirements, and that any transmission of identifiable subject data to Openwater or its service providers is covered by appropriate approvals and agreements.
By purchasing and/or using Open‑LIFU, Customer acknowledges the foregoing and assumes responsibility for ensuring that all conditions for Research Use Only use on humans are met, except to the extent a different use is expressly permitted under applicable law.
Last update: February 13, 2026