Terms and Conditions

Effective April 10, 2026

1. Services

Human Factors Research (hereafter "Company," "we," "us," or "our") is a PhD-led medical device human factors consulting firm based in San Diego, California. We provide specialized consulting services in human factors engineering, usability analysis, and regulatory compliance support for medical devices and related products.

The services described in your engagement agreement or statement of work (hereafter "Services") are provided in accordance with these Terms and Conditions. The Services are provided for professional consulting purposes only and are intended to support informed decision-making by the Client.

2. Engagement Terms

2.1 Scope of Work: The specific scope, deliverables, timeline, and compensation for Services shall be set forth in a written engagement agreement or statement of work executed by both parties. In the event of any conflict between these Terms and Conditions and the engagement agreement, the engagement agreement shall control to the extent of the conflict.

2.2 Payment: The Client agrees to pay all invoices for Services rendered within thirty (30) days of invoice date, unless otherwise specified in the engagement agreement. Invoices are based on the agreed-upon fee structure, whether hourly, project-based, or retainer-based. Late payments may accrue interest at 1.5% per month or the maximum rate permitted by California law, whichever is lower.

2.3 Expenses: Unless otherwise agreed in writing, the Client shall reimburse the Company for all reasonable out-of-pocket expenses incurred in performing the Services, including travel, materials, and third-party fees, at cost plus reasonable administrative overhead.

2.4 Term and Termination: The engagement shall commence on the date specified in the engagement agreement and continue until completion of the Services, unless sooner terminated. Either party may terminate the engagement with fourteen (14) days' written notice. Upon termination, the Client shall pay for all Services performed and expenses incurred up to the effective date of termination.

3. Intellectual Property

3.1 Work Product: Any work product, reports, analyses, methodologies, and deliverables specifically created for the Client pursuant to the engagement agreement (hereafter "Work Product") shall be deemed a "work made for hire" under the Copyright Act and shall be owned exclusively by the Client, provided that all fees and expenses have been paid in full.

3.2 Pre-Existing Materials: The Company retains all right, title, and interest in any pre-existing materials, tools, templates, methodologies, frameworks, and processes used in performing the Services, including but not limited to our proprietary human factors analysis models, data sets, and consulting frameworks. The Client receives a non-exclusive, limited license to use such pre-existing materials solely in connection with the Work Product delivered under the engagement.

3.3 Residuals: The Company may retain and use any general knowledge, experience, ideas, concepts, and know-how acquired during the performance of Services, provided that such use does not breach the Client's confidential information or violate applicable law.

3.4 Attribution: Unless otherwise agreed, the Company may identify the Client as a reference client and may use case study information regarding the Services performed, provided that sensitive or proprietary Client information remains confidential.

4. Confidentiality

4.1 Confidential Information: Each party acknowledges that it may receive confidential, proprietary, or sensitive information from the other party in connection with the Services ("Confidential Information"). Confidential Information includes but is not limited to technical data, business plans, financial information, product specifications, regulatory submissions, and any other information marked as confidential or reasonably understood to be confidential.

4.2 Obligations: Each party agrees to maintain the confidentiality of the other party's Confidential Information and to use such information solely for the purpose of performing or receiving the Services. Neither party shall disclose Confidential Information to third parties without the prior written consent of the disclosing party, except as required by law or as necessary to perform the Services with the Client's prior written approval.

4.3 Exceptions: Confidentiality obligations shall not apply to information that: (a) is or becomes publicly available through no breach of these Terms; (b) was rightfully known to the receiving party prior to disclosure; (c) is independently developed without use of Confidential Information; or (d) is rightfully received from a third party without confidentiality obligations.

4.4 Return of Information: Upon termination of the engagement or upon request, each party shall promptly return or destroy all Confidential Information of the other party, as directed by the disclosing party, and certify such return or destruction in writing.

4.5 Duration: Confidentiality obligations shall survive termination of the engagement for a period of five (5) years, or longer if required by applicable law.

5. Limitation of Liability

5.1 Disclaimer: THE COMPANY PROVIDES SERVICES ON AN "AS-IS" BASIS. EXCEPT AS EXPRESSLY PROVIDED IN THE ENGAGEMENT AGREEMENT, THE COMPANY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. The Company does not warrant that Services will meet all of the Client's requirements or expectations, or that Services will be uninterrupted or error-free.

5.2 Professional Services: The Services are provided as professional consulting services. The Company's recommendations and analyses are based on information available at the time of performance and are not binding predictions of future performance or regulatory approval. The Client acknowledges that the Client retains ultimate responsibility for all design, engineering, regulatory, and business decisions related to Client's products and services.

5.3 Limitation of Damages: EXCEPT IN CASES OF GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR BREACH OF CONFIDENTIALITY OBLIGATIONS, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES, INCLUDING LOST PROFITS, LOSS OF REVENUE, OR LOSS OF DATA, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

5.4 Cap on Liability: EXCEPT IN CASES OF GROSS NEGLIGENCE, WILLFUL MISCONDUCT, OR BREACH OF CONFIDENTIALITY OBLIGATIONS, EACH PARTY'S TOTAL AGGREGATE LIABILITY UNDER THESE TERMS AND CONDITIONS SHALL NOT EXCEED THE TOTAL FEES PAID OR PAYABLE BY THE CLIENT FOR THE SERVICES DURING THE TWELVE (12) MONTHS PRECEDING THE CLAIM.

5.5 Client's Responsibility: The Client assumes all responsibility for the use of Services and Work Product. The Company shall not be liable for any damage, loss, or injury arising from the Client's use, misuse, or reliance on the Services or Work Product.

6. Indemnification

6.1 By Company: The Company shall indemnify, defend, and hold harmless the Client from any third-party claims, damages, and costs (including reasonable attorneys' fees) arising from: (a) the Company's breach of these Terms and Conditions; (b) the Company's gross negligence or willful misconduct; or (c) the Company's infringement of any third-party intellectual property rights in the Work Product, provided that the Client has not modified the Work Product without the Company's consent and has not used the Work Product outside the scope of the engagement.

6.2 By Client: The Client shall indemnify, defend, and hold harmless the Company from any third-party claims, damages, and costs (including reasonable attorneys' fees) arising from: (a) the Client's breach of these Terms and Conditions; (b) the Client's use of Services or Work Product in violation of applicable law; (c) the Client's incorporation of Services or Work Product into products or services without proper regulatory clearance; or (d) the Client's misuse or modification of Work Product outside the scope of the engagement.

6.3 Indemnification Procedure: The indemnified party shall provide prompt written notice of any claim and reasonable cooperation in defense. The indemnifying party shall have control of defense and settlement, provided settlements do not admit liability on behalf of the indemnified party without consent.

7. Regulatory and Compliance Matters

7.1 No Regulatory Guarantee: The Company provides human factors consulting and analysis to support the Client's regulatory and business decision-making. However, the Company does not guarantee that Services will result in regulatory approval, clearance, or compliance with any applicable law or regulation. Regulatory decisions are within the sole authority of regulatory agencies and the Client.

7.2 Client Responsibility: The Client remains solely responsible for ensuring compliance with applicable laws and regulations, including FDA regulations, ISO standards, and any other regulatory requirements applicable to Client's products or services. The Client should consult with its own regulatory counsel regarding compliance matters.

7.3 Regulatory Submissions: If the Client elects to reference the Company's work or recommendations in regulatory submissions to any government agency, the Client shall provide the Company with advance notice and opportunity to review such submission. The Company's consent to the use of its work in regulatory submissions shall not constitute a representation regarding adequacy, sufficiency, or regulatory approval.

8. Governing Law and Dispute Resolution

8.1 Governing Law: These Terms and Conditions and all engagement agreements shall be governed by and construed in accordance with the laws of the State of California, without regard to conflicts of law principles. The United Nations Convention on Contracts for the International Sale of Goods shall not apply.

8.2 Jurisdiction and Venue: Each party irrevocably consents to the exclusive jurisdiction of the state and federal courts located in San Diego County, California, and waives any objection to venue or claim of inconvenient forum.

8.3 Dispute Resolution: Before initiating litigation, the parties agree to attempt to resolve any dispute through good-faith negotiation between senior representatives of each party. If negotiation fails, the parties may pursue mediation or arbitration as mutually agreed, or litigation as permitted by law.

8.4 Attorneys' Fees: In any legal action or proceeding relating to these Terms and Conditions, the prevailing party shall be entitled to recover its reasonable attorneys' fees and costs.

9. Modifications and Amendments

9.1 Changes to Terms: The Company reserves the right to modify these Terms and Conditions at any time. Continued engagement with the Company following notice of modification constitutes acceptance of the modified Terms. Material modifications will be communicated to the Client in writing.

9.2 Changes to Services: Changes to the scope of Services, deliverables, timeline, or compensation shall be documented in a written change order signed by authorized representatives of both parties before implementation.

10. Additional Provisions

10.1 Entire Agreement: These Terms and Conditions, together with any executed engagement agreement or statement of work, constitute the entire agreement between the parties regarding the subject matter and supersede all prior negotiations, representations, and agreements, whether written or oral.

10.2 Severability: If any provision of these Terms and Conditions is found to be invalid or unenforceable, the remaining provisions shall continue in full force and effect.

10.3 No Waiver: The failure of either party to enforce any provision of these Terms and Conditions shall not constitute a waiver of that provision or any other provision.

10.4 Assignment: Neither party may assign its rights or obligations under these Terms and Conditions without the prior written consent of the other party, except that the Company may assign rights and obligations to an affiliate or successor entity. Any attempted assignment in violation of this provision shall be void.

10.5 Independent Contractors: The Company and Client are independent contractors. Nothing in these Terms and Conditions creates a partnership, joint venture, agency, or employment relationship.

10.6 Notice: All notices required under these Terms and Conditions shall be in writing and delivered personally, by email, by certified mail, or by reputable overnight courier to the addresses specified by each party. Notices shall be effective upon receipt.

10.7 Contact Information: For inquiries regarding these Terms and Conditions or the Services, please contact Human Factors Research at:

11. Acknowledgment

By engaging with Human Factors Research and accepting our Services, you acknowledge that you have read, understood, and agree to be bound by these Terms and Conditions in their entirety.