Effective Date: September 28, 2026 – Version 2.0

These Terms & Conditions apply to all quotes, orders, and agreements signed on or after the Effective Date. Agreements signed before that date are governed by the Terms & Conditions in effect on the date of signature.

These Terms and Conditions apply to all laboratory testing, sterilization, consulting, protocol development, validation support, regulatory support, and related services provided by Canyon Labs, including its affiliates and operating sites, to the customer identified in the applicable quote, purchase order, service agreement, sample submission form, or other ordering document.

1. Definitions, Agreement Scope, Order of Precedence

For purposes of these Terms and Conditions, “Canyon Labs” means Canyon Labs Holdings, LLC and its applicable affiliates, laboratories, employees, agents, and approved subcontractors. “Customer” means the person or entity requesting, ordering, or receiving services. “Services” means all testing, sterilization, consulting, protocol development, validation support, regulatory support, reporting, data generation, sample handling, storage, and related activities performed by Canyon Labs. “Samples” or “Test Articles” means any materials, devices, products, components, substances, organisms, packaging, media, or other items submitted to Canyon Labs. “Reports” means final reports, preliminary reports, certificates, letters, data packages, protocols, amendments, and related deliverables.

These Terms and Conditions govern all Services unless Canyon Labs expressly agrees otherwise in a written agreement signed by an authorized officer of Canyon Labs. If these Terms and Conditions conflict with a fully executed master services agreement, quality agreement, or other written service agreement between the parties, the terms of that executed agreement will control solely to the extent of the conflict. Customer purchase order terms, portal terms, vendor onboarding terms, or other Customer-proposed terms are rejected and will not apply unless expressly accepted in writing by Canyon Labs.

2. Quotations, Orders, and Customer Authorization

Unless withdrawn earlier, Canyon Labs quotations are valid for ninety (90) days from the date issued. A quotation is not an obligation by Canyon Labs to perform Services and becomes binding only when accepted by Canyon Labs through written confirmation, acceptance of a purchase order, initiation of Services, receipt of Samples, or other written confirmation.

Customer represents that any person requesting a quote, submitting Samples, approving a protocol, authorizing a change, issuing a purchase order, or otherwise directing Canyon Labs to perform Services is authorized to bind Customer and make technical, operational, and cost decisions on Customer’s behalf. Customer is responsible for determining that the Services ordered are suitable for Customer’s intended use.

3. Pricing, Taxes, Additional Fees, and Change Orders

Prices are based on the assumptions, scope, methods, quantities, timelines, documentation, Sample characteristics, and Customer-provided information reflected in the applicable quotation or proposal. Prices may be revised if those assumptions change, if applicable protocols or Test Article specifications are not available or complete at the time of quotation, if the scope changes, or if additional work is required. Any change in scope, timeline, or fees may be documented in a revised quotation, change order, or written approval.

Prices do not include sales, use, excise, import, customs, shipping, courier, handling, or similar taxes, duties, fees, or charges, all of which are Customer’s responsibility. All prices are stated in U.S. dollars unless otherwise expressly stated. If Customer uses a credit card, Canyon Labs may charge an additional five percent (5%) service fee.

• Testing involving pooling, disassembly, sub-component preparation, extended handling, or other non-standard preparation not evident at the time of quotation may incur additional fees.
• Additional microbiology assessment, including subculturing caused by turbid media or inability to determine microbial growth, may incur additional fees.
• Laboratory investigations not attributable to Canyon Labs error are billable. The minimum standard investigation charge is $1,100, which includes six (6) hours of investigation time. Additional investigation time is billed at $225 per hour.
• Microbial identification is billed at $350 per sample, and STAT identification is billed at $700 per sample.
• Protocol or report revision requests over two revisions not caused by Canyon Labs error or omission are billed at $250 per revision.
• Interim reports may be requested and are billed at a minimum of $625 per report.

4. Credit Terms, Invoicing, Payment, and Payment Default

Credit is granted at Canyon Labs’ sole discretion and may be canceled, reduced, or withheld at any time. Unless otherwise agreed in writing, invoices are due thirty (30) days from the invoice date. Canyon Labs may require prepayment, including for new customers, international customers, customers without approved credit, or orders exceeding $5,000. Canyon Labs may require a fifty percent (50%) prepayment on orders exceeding $5,000 before initiating Services unless otherwise agreed in writing.

Customer’s payment obligation is unconditional and is not contingent on Customer receiving payment from any third party, obtaining regulatory acceptance, receiving a specific test result, or receiving approval from any customer, agency, notified body, sponsor, or other third party. Customer remains responsible for all Services performed and costs incurred through any suspension, cancellation, or termination date.

If Customer fails to pay when due, Canyon Labs may suspend work, withhold Reports, withhold data, accelerate all outstanding invoices, require prepayment for future Services, and recover all collection costs, including reasonable attorneys’ fees. Overdue balances accrue a service charge of one and one-half percent (1.5%) per month or the highest rate permitted by law, whichever is lower. Returned checks are subject to a $100 service fee. Customer remains responsible for any payment that is mislabeled, misdirected, sent to an incorrect account, or otherwise not received by Canyon Labs.

5. Sample Submission, Shipping, Storage, and Customer Deliverables

Customer is responsible for providing complete and accurate sample submission forms, purchase orders, signed quotes, protocols, specifications, questionnaires, safety information, storage requirements, regulatory requirements, and all other information required for Canyon Labs to perform the Services. Customer is responsible for proper Sample labeling, packaging, shipping, classification, customs documentation, import/export documentation, hazard disclosure, and delivery to Canyon Labs.

Customer represents and warrants that it owns, controls, possesses, or otherwise has all rights, permissions, licenses, and authority necessary to provide the Samples to Canyon Labs and authorize the Services. Customer further represents that Canyon Labs’ receipt, handling, testing, storage, transportation, destruction, or other authorized use of the Samples will not violate any law, intellectual property right, contractual restriction, confidentiality obligation, or third-party right.

Canyon Labs may reject, place on hold, return, destroy, or impose additional fees for Samples that are improperly labeled, insufficient in quantity, damaged, compromised, received outside required conditions, lacking required documentation, hazardous, infectious, toxic, radioactive, controlled, illegal, prohibited, or otherwise unsuitable for testing. Customer must disclose in advance any biological, chemical, toxicological, infectious, radioactive, controlled, hazardous, or regulated characteristics of Samples.

Customer is responsible for transportation, courier accounts, shipping costs, and all risk of loss, damage, delay, storage, or mishandling before Canyon Labs receives the Samples and after Samples or materials leave Canyon Labs. Shipping and handling will be charged to Customer’s courier account when available. If Customer does not provide a courier account, Canyon Labs may invoice Customer for estimated shipping plus fifteen percent (15%).

6. Timelines, Lead Times, TAT, and STAT Testing

Turnaround time (“TAT”) means the estimated period from the time all prerequisites for testing are met through report issuance. Lead time (“LT”) means the estimated period from the time all prerequisites for testing are met through test initiation. Prerequisites may include receipt of Samples, purchase order, signed quote, fully completed sample submission form, applicable protocols, questionnaires, checklists, safety disclosures, required approvals, and any other documentation needed for the Services.

All timelines are estimates and not guarantees. Timelines may vary based on laboratory availability, Sample arrival, Sample condition, method complexity, investigations, retesting, subcontractor availability, equipment downtime, supply constraints, Customer delays, incomplete documentation, and other operational factors. If multiple line items are included in a quote, the total project timeline may not equal the sum of individual test timelines.

STAT testing is available upon request and subject to operational capacity, test type, Sample condition, and laboratory acceptance. To initiate STAT testing on the same business day, Samples must be received by noon local laboratory time unless Canyon Labs agrees otherwise. Samples received after the cut-off may be placed on test the next business day. Advance notice of STAT submissions is strongly advised. Cancellation of STAT testing is subject to a charge equal to fifty percent (50%) of the STAT fee.

7. Testing Standards, Accreditation, Protocols, and Subcontractors

Canyon Labs will perform testing in accordance with applicable referenced protocols, methods, and agreed written instructions, and reported results will be accurate within generally accepted commercial ranges of accuracy unless another standard is expressly agreed in writing. Customer is solely responsible for confirming that Canyon Labs’ accreditations, certifications, methods, documentation, protocols, and reports satisfy Customer’s regulatory, commercial, product, customer, or submission requirements.

Canyon Labs may issue protocols upon Customer request. Canyon Labs may require a purchase order or written authorization before releasing protocols when Samples have not yet been submitted. Protocols issued but not used in testing within three (3) months may be invoiced for the time required to prepare the protocol. Canyon Labs may use qualified subcontractors to perform any portion of the Services and may invoice Customer for subcontracted Services at Canyon Labs’ applicable rates. Customer may be notified when subcontracted Services require approval.

8. Reports, Report Acceptance, Investigations, Retesting, and Revisions

Reports are issued solely for the exclusive use of the Customer to whom they are addressed and apply only to the specific Samples tested under the stated conditions, methods, protocols, and assumptions. No other person or entity may rely on or use a Report without Canyon Labs’ prior written consent. Canyon Labs is not responsible for deductions, inferences, extrapolations, regulatory conclusions, marketing claims, or generalizations drawn by Customer or any third party from Canyon Labs’ Reports or data.

Customer must notify Canyon Labs in writing within thirty (30) days after report issuance if Customer requests verification, correction, clarification, or review of any portion of a Report. Failure to notify Canyon Labs within that period constitutes acceptance of the Report. Retesting, investigation, microbial identification, report revisions, protocol amendments, preliminary reports, and other additional work are billable unless required solely due to Canyon Labs error or omission.

Out-of-specification, unexpected, inconclusive, invalid, contaminated, or otherwise atypical results may require investigation, retesting, microbial identification, deviation documentation, customer consultation, or additional Services. Customer remains responsible for determining the regulatory, product, batch, manufacturing, quality, and business implications of such results.

9. Sample/Test Article Retention and Data/Record Retention

Untested material will be held for two (2) weeks after the test report is issued and then returned or discarded according to Customer’s sample submission form instructions. Tested material identified for return on the sample submission form will be held for two (2) weeks after the test report is issued and then returned to Customer. Tested material identified for discard may be discarded immediately after testing with no hold period.

Some materials are not eligible for return, including materials consumed or destroyed during testing, materials that disintegrate or dissolve, materials that cannot be collected for return, items that contacted biohazards, chemical hazards, inoculum, or implanted materials, and reserve or retain samples required to be held by regulation, protocol, or Canyon Labs procedure. Record and Sample return requests may be subject to a $100 charge. Canyon Labs may charge additional storage or warehousing fees if Samples are received more than fourteen (14) days before the agreed start date, before receipt of a purchase order, or before all required documentation is complete.

Canyon Labs will retain GLP study records for at least five (5) full calendar years after test completion, or as otherwise required by law, protocol, or written agreement. Canyon Labs will retain non-GLP study records for at least two (2) full calendar years after test completion, or as otherwise required by law, protocol, or written agreement. File storage beyond the defined retention time may be billed at $100 per study per year or at another rate set by Canyon Labs. If applicable storage fees are not paid when due, Canyon Labs may destroy, delete, or dispose of records or files to the extent permitted by law and applicable quality requirements.

10. Confidentiality and Data Protection

Canyon Labs will manage information obtained or created during the performance of Services and will keep such information confidential unless disclosure is authorized by Customer, required by law, required by accreditation or regulatory obligations, necessary for subcontractor performance, or otherwise permitted by written agreement. Confidentiality obligations do not apply to information that (i) becomes publicly available through no fault of the receiving party; (ii) was lawfully known by the receiving party before disclosure; (iii) is independently developed without use of the disclosing party’s confidential information; or (iv) is lawfully received from a third party without restriction.

Unless otherwise agreed in writing, confidentiality obligations remain in effect for three (3) years from completion of the applicable Services.

To the extent Personal Information is exchanged or processed in connection with the Services, each party is responsible for complying with applicable data protection laws. Each party will notify the other party in advance if Personal Information subject to specific data protection requirements will be transferred. If required by applicable law, the parties will enter into a data processing agreement governing such processing and transfer.

11. Intellectual Property; Use of Name and Reports

All Canyon Labs methods, protocols, templates, procedures, processes, know-how, copyrights, trademarks, trade names, and other intellectual property remain the sole property of Canyon Labs. No rights in Canyon Labs intellectual property are transferred by quotation, purchase order, invoice, performance of Services, or delivery of Reports.

Customer may not quote from Reports, reproduce Reports except for Customer’s internal use, use Canyon Labs’ name, logo, trade name, or trademarks, or refer to Canyon Labs in marketing, public statements, regulatory communications, customer communications, litigation, or other third-party communications without Canyon Labs’ prior written consent, except to the extent required by law or regulation.

Customer may not alter, excerpt, selectively quote, summarize, reformat, manipulate, or present any Report, data, findings, conclusions, or other Canyon Labs work product in a misleading, incomplete, or inaccurate manner. Any partial use of a Report requires Canyon Labs’ prior written approval unless otherwise required by law.

12. Limitation of Liability, Indemnification, Third-Party Claims

To the fullest extent permitted by law, Canyon Labs will not be liable for indirect, incidental, consequential, special, exemplary, punitive, or enhanced damages, including lost profits, lost revenue, loss of use, business interruption, recall costs, replacement product costs, regulatory delay, or loss of market opportunity, whether arising in contract, tort, negligence, strict liability, warranty, or otherwise, even if Canyon Labs has been advised of the possibility of such damages.

Canyon Labs’ total aggregate liability arising out of or relating to the Services, Reports, Samples, data, or these Terms and Conditions will not exceed the amount paid by Customer to Canyon Labs for the specific Services giving rise to the claim. Customer agrees to indemnify, defend, and hold harmless Canyon Labs and its directors, officers, employees, affiliates, agents, and subcontractors from losses, claims, damages, liabilities, costs, and expenses, including reasonable attorneys’ fees, arising out of or relating to Customer’s products, Samples, instructions, omissions, regulatory submissions, use of Reports or data, third-party claims, or breach of these Terms and Conditions.

13. Suspension, Cancellation, Delay Fees, and Force Majeure

Canyon Labs may suspend or delay Services if Customer fails to pay, fails to provide required documentation, fails to provide suitable Samples, changes scope, causes delays, requests a hold, or otherwise prevents timely performance. Customer remains responsible for Services performed, expenses incurred, reserved capacity, materials, subcontractor charges, and other costs arising before or during any suspension, delay, cancellation, or termination.

The cancellation fee schedule is as follows, calculated as a percentage of the total study price or quoted line item plus applicable expenses: up to ten percent (10%) if cancelled after confirmation of the contract; up to fifty percent (50%) if cancelled after work has been initiated; and up to one hundred percent (100%) if cancelled after Canyon Labs completes fifty percent (50%) or more of the scope of work. Customer-caused delays after receipt of Test Articles may be subject to a ten percent (10%) delay fee for delays of zero (0) to fourteen (14) days, and turnaround time may be impacted.

Canyon Labs will not be liable for any failure or delay in performance caused by circumstances beyond its reasonable control, including acts of God, fire, flood, earthquake, severe weather, labor disturbances, epidemics, pandemics, government actions, regulatory restrictions, equipment breakdown, utility interruption, supply chain disruption, subcontractor delay, carrier delay, or other events making performance impracticable. In such cases, Canyon Labs’ obligations are suspended for the duration of the delay and timelines may be extended accordingly.

14. Customer Changes; Assignment; Credit Information

Customer must notify Canyon Labs in writing within ten (10) days of any change of address, billing contact, ownership, control, legal name, or business status. Failure to provide notice may cause all outstanding balances to become immediately due. Canyon Labs may require Customer to submit or update a credit application following any such change or if Customer has not used Canyon Labs’ Services for twenty-four (24) months.

Customer may not assign or transfer any rights or obligations under these Terms and Conditions, any quote, order, or agreement without Canyon Labs’ prior written consent. Canyon Labs may delegate obligations to affiliates, agents, suppliers, and contractors as needed to perform the Services. Customer authorizes Canyon Labs to obtain, use, transmit, and retain credit-related information for credit risk management, fraud prevention, collections, and related business purposes, subject to applicable law.

15. Compliance Terms: Export Controls, Sanctions, Non-Solicitation, and Non-Exclusivity

Customer is responsible for complying with all applicable laws and regulations relating to Samples, products, Services, imports, exports, customs, sanctions, restricted parties, hazardous materials, controlled substances, and data transfers. Technical data, Services, hardware, or Samples may be subject to U.S. export control laws and restrictions on disclosure or shipment to foreign persons. Customer will indemnify Canyon Labs from any breach of such requirements following Customer’s receipt of export-controlled data, hardware, materials, or Services.

During the term of the applicable project and for twelve (12) months after final billing, Customer may not directly offer employment to, induce, solicit, or entice any Canyon Labs employee, consultant, or director who worked directly on the project or related Services. Nothing in any proposal, project agreement, or these Terms and Conditions creates exclusivity. Customer may engage third parties, and Canyon Labs may provide similar services to other customers.

16. Dispute Resolution, Governing Law, and Venue

This agreement shall be governed by and construed in accordance with the laws of the State of Utah. The parties hereto consent to the exclusive jurisdiction of the state and federal courts of the State of Utah, located in Salt Lake City. No action, claim, counterclaim, proceeding or dispute may be commenced, prosecuted or continued in any court other than the state and federal courts of the State of Utah, located in Salt Lake City. In the event that litigation results from or relates to this agreement, the prevailing party shall be entitled to recover reasonable attorneys’ fees, court costs, and all other expenses from the other party, in addition to any other relief to which the prevailing party may be entitled.

The courts identified above shall have exclusive jurisdiction over collection actions, nonpayment disputes, claims for injunctive relief, and any action to compel arbitration or to confirm, enforce, vacate, or modify an arbitration award. Except for those matters, any dispute relating to Customer, the Services, Reports, data, Samples, or these Terms and Conditions will be resolved by confidential, binding arbitration administered by the American Arbitration Association under its Commercial Arbitration Rules. The arbitration venue will be Salt Lake City, Utah, before a single arbitrator with substantial business, commercial, legal, or judicial experience. The arbitrator may not award incidental, consequential, punitive, or special damages or disregard the limitations of liability stated in these Terms and Conditions. In any such arbitration, the prevailing party shall be entitled to recover reasonable attorneys’ fees, costs, and expenses to the same extent provided above for litigation. Judgment on the arbitration award may be entered by any court of competent jurisdiction described above.

17. General Provisions

These Terms and Conditions, together with the applicable Canyon Labs quote, accepted purchase order excluding Customer-proposed terms, service agreement, sample submission form, protocol, and written project confirmation, constitute the entire agreement between the parties for the applicable Services. Any variation, cancellation, or addition is effective only if in writing and signed or otherwise accepted in writing by Canyon Labs.

If any provision is held invalid or unenforceable, the remaining provisions remain in full force to the maximum extent permitted by law. Failure to enforce any provision is not a waiver. Any waiver must be in writing and applies only to the specific matter stated. Notices must be provided in writing to the parties’ designated business, billing, legal, or project contacts, or to another address designated in writing. Provisions relating to payment, confidentiality, data protection, intellectual property, use of name and Reports, limitation of liability, indemnification, dispute resolution, governing law, records, compliance, and any provisions that by their nature should survive will survive completion, cancellation, termination, or expiration of the Services.