Pelara LIFU — A new frequency of care

Terms & Conditions

PELARA, INC.

Terms and Conditions

Product Sale, Services, and Support Agreement

These Terms and Conditions, together with any separately executed order form(s) (“Order Form(s)”), constitute the entire agreement (“Agreement”) between Pelara, Inc., with offices at 29250 Old Fredericksburg Rd, suite 104, Boerne, TX 78015 (“Pelara”), 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): Pelara 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, Pelara will sell to Customer, and Customer will purchase from Pelara, the quantity of Product set forth in the Order Form.

1.2

Unless otherwise set forth in writing by Pelara, all shipments of Product are made F.O.B. Pelara’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. Pelara 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, Pelara 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 Pelara 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 Pelara of any such Nonconforming Product, Pelara shall, in its sole discretion, either (i) repair or replace such Nonconforming Product at Pelara’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 Pelara at Pelara’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 Pelara 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, Pelara 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 Pelara’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 Pelara’s Designated Warranty Contact during the Warranty Period. If Pelara 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”), Pelara will use commercially reasonable efforts to address the problem at no cost to Customer. If such efforts fail to correct the Defect, Pelara will, at its sole option, repair or replace the affected Product, or, if Pelara determines in its sole discretion that it 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 Pelara to verify the Defect and perform its obligations in this Section 3.1. Customer understands and agrees that failure to do so will prevent Pelara from performing such obligations, and voids the Limited Product Warranty set forth herein.

The Limited Product Warranty does not apply to, and Pelara will have no obligation under this Section 3.1 with respect to:

  • damage, failure, or malfunction resulting from misuse, abuse, accident, neglect, improper handling, or failure to follow Pelara’s recommended maintenance, installation, and operating procedures;
  • damage caused by external or environmental factors, including without limitation fire, flood, power surges, power outages, natural disasters, or other events outside Pelara’s reasonable control;
  • normal wear and tear from extended use;
  • any Product that has been modified, repaired, or serviced by anyone other than Pelara or its expressly authorized service providers;
  • consumables, disposable components, or other items intended to be replaced in the ordinary course of use; or
  • software issues caused by unauthorized third-party software, integration, or user error.

Pelara 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 Pelara 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 Pelara 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 Pelara 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 Pelara according to Section 3.1 is Customer’s sole remedy, and Pelara’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. Pelara 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 Pelara’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 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 Pelara’s documentation or website.

4.2

“Proprietary Software” means the object code version of all software (a) installed on the Products, or (b) otherwise provided by Pelara 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, Pelara 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 Pelara. 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

Pelara 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 Pelara, and (f) all improvements to the Product derived from Safety Data (defined below).

5. Restrictions and Responsibilities

5.1

The Product is provided for veterinary research and commercial animal health use only. Customer agrees to use the Product solely for lawful animal health, research, and therapeutic applications and not for any human diagnostic or therapeutic purpose or any other use for which the results are used to determine the course of human patient care. Customer acknowledges that (i) Pelara’s Products are intended for animal health applications and have not been approved, cleared, or licensed by the United States Food and Drug Administration for human use, and (ii) Customer must ensure it has any regulatory approvals, institutional authorizations, or licenses 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 Pelara (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 Pelara’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 Pelara to provide any Services. The foregoing does not limit any other legal or equitable remedy available to Pelara.

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”). Pelara 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. Pelara 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. Pelara 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 Pelara 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 for animal health and veterinary use. The Customer shall not use, or permit the use of, the Product for human diagnostic or therapeutic procedures, nor make any representation, express or implied, that the Product is safe or effective for any human medical use. The Customer is solely responsible for obtaining all necessary regulatory approvals, including institutional approvals and informed consent for any research involving animal subjects subject to oversight. The Customer shall ensure that all labeling, documentation, and communications regarding the Product accurately reflect its intended animal health use. Any data generated using the Product may not be used to support human clinical decisions or human patient care, nor submitted for human regulatory approval without Pelara’s prior written consent. The Customer shall indemnify and hold Pelara 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 required institutional approvals, 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 Pelara’s provision of Services.

(b) On-Site Access. If Services are performed at Customer’s facilities, Customer grants Pelara 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 Pelara’s personnel do not interfere with clinical or operational activities.

(c) Clinical/Research Environment. If Services are provided in a clinical, hospital, or veterinary research environment, Customer is solely responsible for: (i) obtaining all necessary institutional approvals and consents; (ii) ensuring Pelara’s presence complies with facility policies and regulations; (iii) ensuring Pelara personnel are not positioned as clinical supervisors or clinical decision-makers; and (iv) maintaining clinical confidentiality and applicable privacy compliance. Pelara’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 Pelara 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 Pelara 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 Pelara 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 Pelara by completing Pelara’s Safety Data Disclosure Form or by emailing Pelara at [email protected]. Customer shall cooperate with Pelara in investigating any such Safety Data and shall provide additional information or documentation as reasonably requested by Pelara. 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 Pelara 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. Pelara may share such Safety Data with its other customers in aggregated or de-identified form, provided that Pelara does not disclose any information that would reasonably identify any individual research subject, except as required by law or regulatory authorities. Pelara 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 Pelara in electronic format and in accordance with any reasonable templates or standards provided by Pelara 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 Pelara is de-identified in accordance with (i) applicable privacy rule 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 Pelara may use Efficacy Data for product improvement and other legitimate business purposes, subject to the confidentiality provisions of this Agreement. Pelara may share such Efficacy Data with its other customers solely in aggregated and de-identified form, provided that Pelara 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 involving analysis or handling of Customer data, the following apply:

(a) De-Identification. Any raw data that Customer provides to Pelara in connection with Services must be de-identified in accordance with applicable privacy standards, institutional policy, and applicable consent agreements. Customer is solely responsible for ensuring de-identification.

(b) Pelara’s Use of Aggregate Data. Pelara 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. Pelara will not identify Customer or any research subject in such uses.

(c) Ownership. Customer retains ownership of its raw research/clinical data. Pelara retains ownership of its methodologies, code, algorithms, and improvements developed during the engagement.

(d) Confidentiality. Any non-published data, code, or analysis provided by Pelara to Customer is confidential and subject to Section 8 (Confidentiality).

7. Payment of Fees

7.1

Customer will pay Pelara 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 Pelara’s net income) unless Customer has provided Pelara 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 Pelara on account thereof. Customer will pay Pelara 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, Pelara 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 Pelara collects information related to the performance of the Product or Services (including the occurrence of and circumstances relating to any Defect), Pelara may freely use and disclose such information provided it does not identify Customer in doing so. Feedback is Pelara’s Proprietary Information, deemed disclosed by Pelara and to which the exceptions set forth in (b) and (d) above do not apply.

8.3

Customer acknowledges that Pelara does not wish to receive any Proprietary Information from Customer that is not necessary for Pelara to perform its obligations under this Agreement (including its Services obligations), and, unless the parties specifically agree otherwise, Pelara may reasonably presume that any information that is not necessary for Pelara to perform such obligations received from Customer is not confidential or Proprietary Information.

8.4  Services and Professional Confidentiality

If Pelara provides Professional Services, Consulting, or custom development, the following apply:

(a) Pelara 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 Pelara for Customer’s own use, subject to applicable open-source license terms (e.g., AGPL).

(c) See the Services MSA 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 Pelara (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 Pelara (or any of its agents, affiliates, licensors or suppliers) have been advised of the possibility of damages, and (B) the total liability of Pelara hereunder, whether based in contract, tort (including negligence or strict liability), or otherwise, with respect to product sales, will not exceed, in the aggregate, the fees actually paid to Pelara 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 Section 10(B), Pelara’s liability for any claim arising from the provision of Services is capped separately as set forth in the Services MSA. 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.

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 Pelara. 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. Pelara 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 [STATE], U.S.A., without regard to conflict-of-law rules, and the state and federal courts located in [COUNTY], [STATE], have exclusive jurisdiction and venue, provided either party may seek injunctive relief in any court of competent jurisdiction. Customer agrees that Pelara may identify Customer as a Pelara 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

Product Specifications

Pelara LIFU 1.0 — Low-Intensity Focused Ultrasound

Pelara’s LIFU platform is a wearable, modular, low-intensity focused ultrasound therapeutic device designed for veterinary applications. The following specifications are preliminary and subject to change.

Sonication Parameters

  • Center frequencies: 100–500 kHz
  • Mechanical Index at focus: 0–1.9 MI
  • Pulse length: 0–100 ms
  • Duty cycle: 0–50%
  • Session duration: 0–15 minutes
  • Focusing range (single module): 3 cm at 150 kHz; 6 cm at 400 kHz
  • Targeting precision: 1 mm focal accuracy
  • Apodization: binary
  • Focal patterns: single, multi (rastered)

Transmit Modules

  • Number of elements: 64 (8×8 grid) per single transducer
  • Center frequencies: 150 kHz, 400 kHz
  • Footprint: 4×4 cm
  • Communication: I2C, TTL
  • Affixation: multiple strap configurations for veterinary species

Console

  • Input power: 120V / 240V AC
  • Output voltage: +/- (5–96V) DC
  • Output power: 60W peak
  • Input communication port: USB-C
  • Size: 6″ x 6″ x 2″

Software Requirements

  • Operating system: Windows 11 or later
  • Memory: 8 GB RAM
  • Storage: 100 GB free storage
  • Connection: 1 available USB-C port (at least USB 3.0)
  • GPU: NVIDIA recommended
  • Simulation engine: K-Wave (Python version)
  • Language: Python

Compliance

  • IEC standards: 60601-1-1, 60601-1-2, 60601-1-6, 60601-2-5, 60601-2-37, 60601-2-62, 62304
  • ISO standards: 13485, 10993

Note: Pelara has not yet been certified for compliance to all listed standards. Preliminary specifications are for informational purposes only and are subject to change.

Exhibit B

Pelara Services and Support Agreement

This Pelara Services and Support Agreement (the “Services MSA” or “Agreement”) is between Pelara, Inc. (“Pelara”) 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 Pelara’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), Professional Services (such as engineering, consulting, and data analysis), and Cloud Services.

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

Pelara’s Services generally fall into the following categories, as further described in Article 2:

  • Orientation and Training: on-site or remote instruction regarding Product setup, operation, safety, and associated software.
  • Support Services: ongoing technical assistance, including virtual technical support and, where applicable, on-site case-day technical support.
  • Annual Platform Support and Maintenance (APSM): optional renewable support and maintenance programs for eligible Products.
  • Professional Services: custom engineering, consulting, study design, data analysis, and related advisory work.
  • Cloud Services: subscription-based access to hosted software and processing capabilities, including the PelaraOS platform and related cloud features, as described in the applicable Order Form.

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

Pelara 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 Pelara 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, Pelara does not commit to specific response times, resolution times, uptime percentages, or 24/7 availability. For standard Support Services, Pelara 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 veterinary medical advice or decision-making; regulatory 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 Pelara 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

Pelara 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 Pelara reasonably believes is illegal, unsafe, or unethical, or if Customer fails to provide necessary access or cooperation. Where practicable, Pelara 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

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.

Where Orientation is performed at Customer’s site, Customer is responsible for: (a) providing a safe, compliant environment; (b) ensuring necessary space, power, and infrastructure are available; and (c) ensuring that Pelara’s presence and activities comply with facility safety, credentialing, and privacy requirements. Pelara personnel attend solely to deliver technical training and do not provide clinical services or assume clinical responsibility.

2.2  Support Services

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 veterinary 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.

Clinical-Technical Case-Day Support consists of on-site technical presence in connection with a clinical case, treatment, or research session, focused on device readiness, basic technical monitoring, and post-case technical follow-up. Customer remains solely responsible for clinical decisions, animal patient safety, and regulatory and institutional compliance.

2.3  Annual Platform Support and Maintenance (APSM)

APSM is an optional, renewable annual program that provides post-warranty support and maintenance for eligible Products. 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.

2.4  Professional Services

Professional Services may include custom engineering, software development or configuration, integration work, data analysis, statistical or methodological consulting, documentation support (for example, protocols or manuscript support), and related advisory services, as described in the applicable Order Form. Pelara will perform Professional Services in a professional and workmanlike manner using commercially reasonable efforts, but does not guarantee any particular outcome.

2.5  Cloud Services — PelaraOS Platform

Cloud Services consist of cloud-hosted software and processing capabilities made available by Pelara on a subscription basis, including the PelaraOS platform for treatment planning, outcomes tracking, session logging, and protocol management that interoperates with the Pelara LIFU system. Customers may continue to use any local, device-based tools provided with the Products at no additional charge; the Cloud Services subscription specifically enables cloud-accelerated processing, outcomes analytics, and associated workflow enhancements.

Unless otherwise stated in the Order Form, Cloud Services are licensed on an annual subscription basis. Customer will not allow more users to access the Cloud Services than the quantity specified, and will not exceed any stated usage limits. 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.

Article 3: On-Site Services Terms

3.1  Site Safety Responsibilities

Customer is solely responsible for the safety and compliance of its facilities, operations, and personnel. Customer will disclose to Pelara any known material environmental, occupational, health, or safety hazards at the site in advance of the visit and ensure the site complies with applicable health and safety laws and regulations. If Pelara reasonably determines that conditions are unsafe or materially different from those disclosed, Pelara may suspend or terminate the on-site Services without liability.

3.2  Insurance and Risk Allocation

Customer will maintain, at its own expense, (i) commercial general liability insurance covering its facilities and operations, (ii) workers’ compensation as required by law, and (iii) if applicable, professional liability coverage for clinical or research activities. Pelara will maintain commercially reasonable insurance coverage for its own operations and personnel. Customer will indemnify, defend, and hold harmless Pelara and its officers, employees, and agents from third-party claims to the extent arising out of Customer’s facilities, operations, site conditions, injuries to Customer’s personnel or animal patients, Customer’s use or misuse of the Products or Services, or Customer’s failure to comply with applicable law.

3.3  Travel and Expense Reimbursement

Where the applicable Order Form provides for reimbursement of travel or out-of-pocket expenses, Customer will reimburse Pelara for reasonable, documented travel and living expenses incurred in providing on-site Services, in accordance with any limits or pre-approval requirements stated in the Order Form.

Article 4: Support Hours, Holidays, and Availability

4.1  Standard Support Hours

Unless otherwise stated in an Order Form, Pelara will make Support Services available during its standard business hours of 9:00 a.m. to 5:00 p.m. Central Time, Monday through Friday, excluding U.S. federal holidays.

4.2  Response Expectations (No SLA)

Pelara will use commercially reasonable efforts to acknowledge support requests received during standard support hours 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, Pelara does not guarantee any specific response time, resolution time, uptime level, or service availability metric.

Article 5: Billing and Payment

5.1  Invoicing

Pelara will invoice Customer for the Services as specified in the applicable Order Form. Invoices may be delivered electronically and will state the Services provided, dates of Service, applicable rates or fees, any approved travel and expenses, and the applicable payment due date.

5.2  Payment Terms

Unless otherwise stated in the applicable Order Form, invoices are due and payable within 30 days of the invoice date (Net 30). Customer may pay by ACH transfer (preferred), check, or credit card. Pelara may charge a reasonable processing fee for credit card payments.

5.3  Late Payments

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. If any undisputed amount remains unpaid more than 15 days after the due date, Pelara may suspend some or all ongoing Services or exercise its termination rights under Article 10.

Article 6: Confidentiality and Data Handling

6.1  Confidentiality

During the Services, each party may disclose to the other confidential or proprietary 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

If Customer provides research data, clinical data, or other proprietary data to Pelara 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; (ii) is provided in compliance with Customer’s institutional data governance requirements; and (iii) is covered by any required institutional or research oversight approvals and participant consents. Pelara will implement reasonable technical and organizational measures to protect Customer data, including encrypted transmission and limiting access to personnel with a need to know.

6.3  Use of De-Identified and Aggregate Information

Pelara may use de-identified, anonymized, or aggregated information derived from the Services to operate, maintain, and improve its products and services, to develop and validate algorithms and methodologies, and to perform internal analytics and benchmarking. In doing so, Pelara will not intentionally identify Customer or any individual.

Article 7: Intellectual Property

7.1  Custom Deliverables

As between the parties, Pelara 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 Pelara in connection with the Services, including all underlying algorithms, methods, code libraries, utilities, know-how, and any improvements or enhancements to Pelara’s pre-existing technology. Subject to Customer’s timely payment of applicable fees, Pelara 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.

7.2  Pre-Existing and Open-Source Materials

Pelara 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 open-source components, those elements are licensed only in accordance with the applicable 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, Pelara may use and incorporate that feedback without restriction and without obligation or compensation to Customer. To the extent necessary, Customer hereby assigns to Pelara all right, title, and interest in and to such feedback.

Article 8: Limitation of Liability for Services

8.1  Disclaimer of Warranties for Services

The Services are provided “as is” and “as available.” Pelara 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, Pelara 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, Pelara’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 Pelara for the specific Service giving rise to the claim during the 12-month period immediately preceding the event giving rise to the claim.

8.3  Excluded Damages

In no event will Pelara 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.

Article 9: Restrictions and Responsibilities

9.1  Customer Use of Services

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, institutional approvals, informed consent, or institutional authorizations for its intended use of the Products and Services. The Services do not constitute veterinary medical services, clinical consultation, or the practice of veterinary medicine. Pelara is not a licensed veterinary healthcare provider and does not assume any clinical responsibility. Customer remains solely responsible for all clinical decision-making, animal patient safety, and clinical outcomes.

Article 10: Term and Termination

10.1  Term

This Services MSA becomes effective on the effective date of the applicable Order Form 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  Termination by Customer

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. Fees for any partially elapsed term are non-refundable unless expressly stated otherwise in this Services MSA or the applicable Order Form.

10.3  Termination by Pelara

Pelara may terminate some or all Services, or this Services MSA, in whole or in part, immediately upon written notice if: (a) Customer materially breaches this Services MSA or the applicable Order Form and fails to cure the breach within 10 days after written notice; (b) any undisputed amount due remains unpaid more than 15 days after the due date; (c) Pelara reasonably determines that providing or continuing Services would create an unacceptable safety risk, regulatory or legal exposure, or involve an illegal or unethical use; or (d) for on-site Services, Customer’s facilities or site access conditions prevent the Services from being performed safely.

10.4  Effect of Termination; Survival

Upon termination or non-renewal of specific Services, Pelara will cease providing those Services, and Customer will no longer receive related benefits. Customer remains responsible for all fees accrued for Services performed up to the effective date of termination and any applicable cancellation fees. The following provisions survive termination or expiration: Article 6 (Confidentiality and Data Handling), Article 7 (Intellectual Property), Article 8 (Limitation of Liability), and any payment and indemnity obligations that by their nature relate to periods prior to termination.

Article 11: Miscellaneous

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. Any change to this Services MSA must be in writing and agreed by authorized representatives of both parties. Customer may not assign this Services MSA without Pelara’s prior written consent. 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. The parties are independent contractors and not partners, joint venturers, agents, or employees of one another.

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 to:

Pelara, Inc.

Email: [email protected]

Exhibit C

Pelara LIFU: Veterinary Use Disclaimer

Pelara LIFU is designed and provided for veterinary animal health applications. It is not cleared or approved by the FDA or any other regulatory authority for human diagnosis, prevention, or treatment of disease, is not intended for human clinical decision-making or human patient management, and may not be used for human clinical care or billed human clinical services.

Pelara LIFU may be used for veterinary therapeutic applications and non-clinical research, including benchtop, phantom, and animal studies, and may only be used in any research involving live animal subjects in settings that meet applicable legal, ethical, and institutional requirements.

If Customer uses Pelara LIFU in research involving animal subjects subject to institutional oversight, Customer represents and agrees that:

  • All animal-subject use will be conducted only under an active, approved IACUC or equivalent protocol, with appropriate animal welfare protections as required by applicable law and institutional policy.
  • Pelara LIFU will be used solely for veterinary research or therapeutic purposes as described in such protocol and will not be used for human medical applications.
  • Pelara 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 animal-subject research and the use of veterinary 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.

By purchasing and/or using Pelara LIFU, Customer acknowledges the foregoing and assumes responsibility for ensuring that all conditions for intended veterinary and research use are met, except to the extent a different use is expressly permitted under applicable law.

Last updated: MAY 2026