Terms of Service

Draft — not for publication as written

PLACEHOLDER: These Terms of Service are a working draft prepared for review. They have not been reviewed by legal counsel and must not be published, referenced in a services agreement, or relied on until qualified counsel has reviewed and approved them in the laboratory's jurisdiction. Every bracketed item below requires an owner or counsel decision. Delete this notice only after that review is complete.

PLACEHOLDER: legal entity name, entity type, state of formation, and registered address. Throughout this document, "Arcadia Diagnostics" or "the Laboratory" should be replaced with the exact legal entity name.

PLACEHOLDER: effective date and version number of these Terms.

1. Agreement and scope

These Terms of Service ("Terms") govern all analytical testing services provided by Arcadia Diagnostics ("the Laboratory", "we", "us") to a client ("the Client", "you"). By requesting a quotation, submitting a sample, or accepting a report, you agree to these Terms.

Where a signed services agreement exists between the Laboratory and the Client, that agreement controls to the extent of any conflict. These Terms otherwise apply in full.

These Terms do not apply to use of the website or the certificate of analysis lookup by members of the public. PLACEHOLDER: separate website and COA portal visitor terms — decide whether these are a distinct document or a section here, and have counsel confirm.

2. What the Laboratory does, and does not do

The Laboratory provides analytical testing of materials — powders, solids, solutions, suspensions, and articles submitted in containers — for research and quality-control purposes.

The Laboratory:

• is not a clinical laboratory. It does not test human or animal biological specimens, does not perform diagnostic testing, and does not provide medical, veterinary, clinical, or legal advice. Clinical laboratory certification does not apply to the analysis of materials and the Laboratory does not hold or claim it.

• reports measurements, not meanings. The Laboratory states what was measured, by what method, under what conditions, with what limits. It does not interpret what a result means for any person, any use, or any decision. That decision belongs to the Client.

• does not evaluate materials for human or animal use. It does not assess safety, efficacy, biological activity, clinical performance, sterility assurance, or fitness for any purpose, and does not certify any material as suitable for administration or consumption.

• does not endorse. Performing testing for a Client is not approval, certification, verification, or endorsement of that Client, its products, its marketing, or its business.

PLACEHOLDER: the Laboratory's actual test menu — which determinations are performed in-house, which are subcontracted, and which are not offered. Do not imply capability for any test not actually available.

PLACEHOLDER: statement of the quality framework the Laboratory actually operates under, for example internal SOP-controlled non-GMP research testing. Do not imply accreditation, GMP status, or regulatory registration unless formally held, with body, number, and scope.

3. Quotations, orders, and acceptance

A quotation states the determinations to be performed, the minimum sample quantity required, the price, and the schedule. A quotation is an offer to perform defined work, not a commitment by the Client and not a guarantee of a particular result.

PLACEHOLDER: quotation validity period, for example 30 days from issue.

Work is scheduled on acceptance of the quotation and receipt of a conforming sample. Scope changes — additional analytes, additional replicates, method development required by an unexpected matrix — are requoted before the additional work is performed.

Turnaround times are estimates unless expressly committed in writing. Turnaround runs from receipt of a conforming sample, not from order date. PLACEHOLDER: committed standard and expedited turnaround times per test, or an explicit statement that turnaround is quoted per project and not guaranteed.

Circumstances that legitimately extend a schedule — and which we will tell you about when they arise, not at delivery — include the absence of an established method for the analyte, the absence of a reference standard, poor solubility or unstable solutions, co-elution discovered during analysis requiring an orthogonal method, insufficient sample quantity, and anomalous results requiring a documented investigation and confirmatory retest.

4. Client responsibilities and warranties

By submitting a sample, the Client represents and warrants that:

• Lawful possession and shipment. The Client owns the material or is authorized to submit it, possesses it lawfully, and that packaging, labeling, and shipment comply with all applicable federal, state, local, and international law and with all carrier requirements.

• Accurate declaration. The declared identity, composition, concentration, and origin of the sample are accurate and complete to the best of the Client's knowledge, including all known or suspected hazards, incompatibilities, storage requirements, and any applicable Safety Data Sheet. Incomplete or inaccurate declaration endangers laboratory personnel and invalidates results.

• No controlled substances without authorization. The sample is not a controlled substance, controlled-substance analog, listed chemical, select agent, or other regulated material, except where the Laboratory has given express written pre-authorization in advance of shipment. Shipping a controlled substance without authorization is a serious offense committed by the sender.

• No biological specimens. The sample is not a human or animal biological specimen of any kind.

• No pre-shipment. The Client will not ship any material before receiving written submission instructions, including the assigned accession number and the confirmed receiving address.

• Authority. The person submitting the sample is authorized to bind the Client to these Terms.

The Laboratory may refuse, quarantine, return, or dispose of any sample that arrives unannounced, undeclared, misdeclared, damaged, leaking, or in apparent violation of law or carrier rules, at the Client's cost and risk, and may notify the appropriate authorities where required to do so.

PLACEHOLDER: controlled-substance intake policy, and DEA analytical laboratory registration plus state controlled-substance license numbers if held — or an explicit statement that the Laboratory does not accept controlled substances of any schedule. Counsel must settle this before any controlled-substance-related service is offered.

5. Samples: ownership, custody, retention, and disposal

Ownership. Title in a submitted sample remains with the Client. The Laboratory holds it as bailee for the purpose of performing the agreed testing.

Consumption. Analysis is destructive of the portion tested. Material consumed in preparation and analysis is not returned and is not replaced.

Custody and condition. Condition on receipt — seal state, temperature, container integrity, quantity — is recorded and appears on the report. The Laboratory is not responsible for degradation occurring before receipt, in transit, or after the sample leaves its custody.

Storage. Retained material is stored under the conditions stated in the report. The Laboratory does not warrant sample stability over the retention period and results are not re-issued against retained material without a new analysis.

Retention. PLACEHOLDER: sample retention period after report issue, and record retention period for raw data and reports. State both separately.

Return. Return of unconsumed material may be requested before the end of the retention period, at the Client's cost and risk, and is subject to the same legality and carrier requirements as the original shipment.

Disposal. After the retention period, remaining material is disposed of in accordance with applicable waste regulations. PLACEHOLDER: disposal method and waste-handling arrangements. Disposal is not reversible and the Laboratory has no obligation to notify before it occurs beyond what is stated here.

6. Methods, subcontracting, and deviations

The Laboratory selects methods appropriate to the requested determination and identifies the method and its version on the report.

Compendial procedures. Where a compendial procedure is followed — for example a USP General Chapter — the report states that the procedure was followed and identifies the chapter. Compendial chapters are drug-product standards. Following the procedure of a chapter is a technical choice; it does not make a research-use-only article a drug product, does not establish compendial compliance, and does not import any acceptance criterion. Where a compendial acceptance criterion is quoted at all, it is quoted for reference and the report says so.

Deviations. Any deviation from the stated method, and its effect on the result, is recorded on the report.

Subcontracting. PLACEHOLDER: subcontracting policy — whether the Laboratory subcontracts any determination, whether prior Client consent is required, and how subcontracted work is identified on the report. Any test not performed in-house must be described as referred, or removed from the service list.

Anomalous results. Out-of-expectation or anomalous results trigger a documented investigation and, where warranted, a confirmatory retest. A result is never quietly re-injected until it looks acceptable.

7. Reports and results

Scope of a result. Results relate only to the item or items tested, in the condition received, on the date received. Unless expressly stated otherwise on the report, the Laboratory was not involved in sampling and makes no representation regarding any lot, batch, unit, or shipment from which the sample was drawn.

Non-detects. A result reported as "not detected" means the named analyte was not observed at or above the stated detection or reporting limit in the aliquot analyzed. It does not mean the analyte is absent. Detection limits are analyte-, method-, and matrix-specific and are stated per analyte.

Panel scope. Only the analytes named in a report were tested for. Compounds outside the reported panel, including novel or emerging substances, were not examined and cannot be excluded by the analysis.

Presumptive and confirmatory results. Where a presumptive screening method is used, the result is labeled presumptive adjacent to the result itself, not in a footnote. A presumptive result — positive or negative — is not an identification and is not suitable for any purpose requiring identification. Confirmatory analysis is a separate service and must be requested.

Purity and content are different quantities. A chromatographic purity figure is a relative area measure of UV-absorbing, column-eluting species under the stated conditions. It is not a mass fraction and it is not a statement of how much of the named compound a container holds. Where content, water, counterion, or residual solvents were not determined, the report says "not determined" rather than remaining silent.

Statements of conformity. Where a report states pass or fail, it is evaluated against acceptance criteria supplied by the Client, identified as the Client's, under a documented decision rule that accounts for measurement uncertainty. The Laboratory does not establish acceptance criteria for research-use-only materials and expresses no opinion on the adequacy of any criterion for any purpose. PLACEHOLDER: documented decision rule, including treatment of measurement uncertainty.

Amendments. A report may be amended or withdrawn if an error is identified. Amended reports are identified as amendments and supersede the prior version. The Client is responsible for ceasing use of any superseded or withdrawn report.

Signature. PLACEHOLDER: authorized signatory name and title for report release.

8. Research use only; no clinical or human-use interpretation

Materials submitted to the Laboratory are accepted as research-use-only materials — articles of laboratory research.

Results characterize the material as an article of laboratory research. They are not a determination of safety, sterility, endotoxin acceptability, biological activity, potency for any use, or fitness for administration to humans or animals, and do not constitute clinical, diagnostic, or therapeutic validation.

The Laboratory does not provide, and will not provide on request, guidance on dosing, administration, reconstitution for human or animal use, or the suitability of any material for consumption. Such requests are declined in writing.

Reports must not be presented as evidence of safety, of approval by any regulatory authority, or of suitability for human or veterinary use. Nothing issued by the Laboratory is medical advice.

9. Use of reports; misrepresentation prohibited

The Client may use reports for its own research, quality-control, and record-keeping purposes, and may provide them to its own customers and regulators, subject to the following.

• Reproduce only in full. Reports may not be reproduced except in full without the prior written approval of the Laboratory. Excerpting, cropping, redacting, or re-typesetting a report in a way that changes or narrows its meaning is prohibited. This specifically includes cropping a chromatogram so that the baseline, the void region, or the region after the main peak is not visible.

• No alteration. Reports may not be altered in any respect.

• No implied endorsement. The Laboratory's name, marks, and reports may not be used to state or imply endorsement, certification, verification, approval, or a warranty of any product, material, or business. The Laboratory issues no seals, badges, or verification marks and does not authorize any party to create one.

• Sample-limited. A report attaches to the sample tested. It may not be presented as applying to any other unit, lot, shipment, or production run.

• No safety claims. A report may not be used to support a claim that a material is safe, pure by mass, clean, free of any substance, verified, authentic, or fit for any use, beyond the precise wording of the report itself.

• Publication. Publication of a report through the certificate of analysis lookup requires the Client's written, revocable authorization identifying the fields to be displayed. Publication is never automatic and never retroactive.

The Laboratory may suspend publication, withdraw a report, decline further work, and terminate the relationship for misuse of a report or of the Laboratory's name.

10. Confidentiality

The Laboratory treats Client identity, sample information, and results as confidential and does not disclose them to third parties except: with the Client's written authorization; to subcontractors engaged for the work under equivalent confidentiality obligations; or where disclosure is required by law, in which case the Laboratory will notify the Client unless prohibited from doing so.

The Laboratory does not confirm or deny to third parties whether any person or company is a client, or whether any product or lot has been tested.

The Client agrees to keep confidential any non-public method, procedure, or pricing information disclosed by the Laboratory.

11. Fees, payment, and cancellation

PLACEHOLDER: pricing basis, invoicing schedule, payment terms and currency, accepted payment methods, late payment interest or fees, and whether work commences before payment or on deposit.

PLACEHOLDER: cancellation and rescheduling policy — what is chargeable once a sample has been logged, prepared, or partially analyzed.

PLACEHOLDER: policy on taxes, duties, and shipping costs, including who bears inbound and return shipping.

A result that the Client finds unfavorable is not grounds for non-payment. The service purchased is the analysis, not a particular outcome.

12. Warranties and limitation of liability

The Laboratory will perform services with reasonable skill and care, using methods appropriate to the requested determination.

Disclaimer. Except as expressly stated in this section, services and reports are provided without warranty of any kind, express or implied, including any implied warranty of merchantability, fitness for a particular purpose, or non-infringement. The Laboratory does not guarantee any particular result, outcome, detection limit on an uncharacterized matrix, or turnaround unless expressly committed in writing.

Client reliance. The Client is solely responsible for its use of, and any reliance on, reports, for the acceptance criteria it applies, and for all representations it makes to third parties.

Remedy. PLACEHOLDER: primary remedy — commonly re-performance of the affected analysis, or refund of the fee paid for it, at the Laboratory's election. Counsel to confirm.

Cap. PLACEHOLDER: aggregate liability cap — commonly limited to the fees paid for the specific analysis giving rise to the claim. Counsel to set, together with any carve-outs for fraud, willful misconduct, or death or personal injury, which cannot be excluded in many jurisdictions.

Consequential loss. PLACEHOLDER: exclusion of indirect, incidental, special, consequential, and punitive damages, and of lost profits, lost revenue, product recall costs, and loss of goodwill. Counsel to confirm enforceability in the governing jurisdiction.

Claims period. PLACEHOLDER: period within which a claim relating to a report must be raised in writing, for example 30 days from issue of the report.

13. Indemnification

The Client shall indemnify, defend, and hold harmless the Laboratory and its personnel against claims, losses, damages, liabilities, and costs arising from:

• the Client's use, publication, excerpting, or characterization of any report, including any representation regarding safety, purity, authenticity, or suitability for use;

• inaccurate, incomplete, or misleading declaration of a sample's identity, composition, or hazards;

• unlawful possession, packaging, or shipment of a sample; and

• the Client's products, materials, and business generally.

PLACEHOLDER: counsel to confirm mutuality, defense control, and notice provisions.

14. Suspension, termination, and force majeure

The Laboratory may suspend or terminate services, with notice, where a Client breaches these Terms, submits a sample in violation of Section 4, misuses a report, or fails to pay amounts due.

Either party may terminate an engagement for convenience on written notice, subject to payment for work performed and materials committed to date.

Neither party is liable for delay or failure to perform caused by events beyond its reasonable control, including instrument failure, reagent or reference-standard unavailability, supply chain interruption, utility failure, carrier failure, natural events, and acts of government.

Sections concerning confidentiality, use of reports, warranties and liability, indemnification, and governing law survive termination.

15. General

Governing law and disputes. PLACEHOLDER: governing law, venue, and dispute resolution mechanism — court, arbitration, or mediation-then-arbitration. Counsel to set.

Assignment. Neither party may assign these Terms without the other's written consent, except to a successor in interest to substantially all of its business.

Severability. If any provision is held unenforceable, the remainder continues in force.

Entire agreement. These Terms, together with any signed services agreement and accepted quotation, constitute the entire agreement between the parties regarding the services and supersede prior discussions.

Changes. The Laboratory may revise these Terms. The version in force at the time a sample is accepted governs that engagement. PLACEHOLDER: how revisions are notified to existing clients, and the version history location.