Terms of service
TrustPointe Analytics LLC — Terms of Service Agreement
Revision 2 Effective 06-Aug-2026
These Terms of Service ("Terms") govern all analytical laboratory services provided by TrustPointe Analytics LLC, a Michigan limited liability company ("TrustPointe," "we," "us," "our"), to the customer submitting samples or requesting services ("Client," "you," "your"). TrustPointe and Client are each a "Party" and together the "Parties."
1. Definitions
1.1 "Services" means the analytical, testing, method development, consulting, and related laboratory services described in an accepted Quote or Statement of Work.
1.2 "Sample" means any material, article, container, or specimen submitted by or on behalf of Client for testing.
1.3 "Quote" means a written quotation, proposal, statement of work, or service order issued by TrustPointe and accepted by Client.
1.4 "Report" means a certificate of analysis, test report, data package, or other written deliverable issued by TrustPointe.
1.5 "Raw Data" means underlying instrument output, chromatograms, worksheets, and laboratory records generated in performing the Services.
2. Acceptance and Order of Precedence
2.1 Acceptance. Client accepts these Terms by any of the following: (a) signing a Quote referencing them; (b) submitting a Sample to TrustPointe; (c) issuing a purchase order for Services; or (d) paying an invoice for Services. Acceptance occurs on the earliest of these events.
2.2 Version Control. The Terms in effect at the time of Sample receipt govern that submission. TrustPointe may revise these Terms prospectively by posting an updated version at https://trustpointeanalytics.com/policies/terms-of-service with a new effective date. Revised Terms do not apply to Samples already in TrustPointe's possession.
2.3 Order of Precedence. In the event of conflict, the following order controls: (1) a Master Services Agreement or Quality Agreement signed by both Parties; (2) any service-specific Addendum to these Terms; (3) the accepted Quote; (4) these Terms.
2.4 Client Forms Rejected. Any additional, conflicting, or preprinted terms in a Client purchase order, portal, vendor onboarding packet, click-through, or other Client document are expressly rejected and have no effect, notwithstanding TrustPointe's acknowledgment of or performance under such document. TrustPointe's performance is not acceptance of Client's terms.
3. Services and Scope
3.1 TrustPointe will perform the Services described in the accepted Quote using the methods identified in that Quote, exercising the degree of skill and care ordinarily exercised by qualified analytical laboratories under similar circumstances.
3.2 The Services are strictly limited to the analyses, methods, and Samples identified in the Quote. No other testing, evaluation, interpretation, or opinion is included or implied.
3.3 Changes. Any change to scope, method, sample count, specification, or turnaround requires a written change to the Quote and may affect price and schedule.
3.4 Turnaround. Turnaround times are good-faith estimates measured from receipt of a conforming Sample, complete test instructions, and any required deposit. Turnaround estimates are not guarantees, and TrustPointe is not liable for delay. Rush service is available at the rates in the applicable Quote.
3.5 Subcontracting. TrustPointe may subcontract any portion of the Services to a qualified laboratory. TrustPointe remains responsible for subcontracted work performed under its Report. TrustPointe will identify subcontracted results in the Report where required by applicable standards.
4. Samples
4.1 Submission. Client is solely responsible for sample selection, sampling technique, statistical representativeness, quantity, labeling, packaging, preservation, chain of custody prior to receipt, and shipment. TrustPointe tests only what it receives, as received.
4.2 Title and Risk. Title to and risk of loss in each Sample remain with Client at all times. Client authorizes TrustPointe to consume, alter, or destroy Samples in the course of testing and disposal.
4.3 Rejection. TrustPointe may refuse or discontinue testing of any Sample that is insufficient in quantity, compromised, improperly labeled, unstable, unsafe, or outside TrustPointe's scope or capability. Client remains responsible for charges incurred prior to rejection.
4.4 Hazardous and Regulated Materials. Client must disclose in writing, before shipment, any known or suspected hazard, biological agent, cytotoxic or highly potent compound, controlled substance, or listed chemical associated with a Sample, and must provide a current Safety Data Sheet. Client will ship in compliance with all applicable transportation and hazardous materials laws. TrustPointe may refuse, return at Client's expense, or dispose of any undisclosed hazardous Sample and will invoice Client for associated costs.
4.5 Controlled Substances. Client will not submit any DEA-scheduled controlled substance or listed chemical without TrustPointe's prior written consent. Client warrants it holds all registrations and authorizations required to possess and ship the Sample.
4.6 Retention, Return, and Disposal. Unless the Quote or a Quality Agreement states otherwise, TrustPointe will retain remaining Sample material for 1 day after Report issuance and may thereafter dispose of it in accordance with applicable law and TrustPointe procedures, at Client's cost. Extended retention or return shipment is available at Client's written request and expense. Storage fees of $10 apply to material retained beyond the standard period. Sample retention obligations imposed on Client by 21 CFR or other regulation remain Client's responsibility.
5. Client Representations and Responsibilities
Client represents, warrants, and covenants that:
5.1 It has the lawful right to possess, ship, and submit each Sample and to authorize the Services;
5.2 All information it provides — including sample identity, matrix, concentration, specifications, methods, and acceptance criteria — is accurate and complete, and TrustPointe may rely on it without independent verification;
5.3 It will not submit any material derived from a human subject in a manner requiring IRB oversight, or any material subject to export control, without prior written disclosure;
5.4 It is solely responsible for determining whether the Services are fit for its intended purpose, for selecting appropriate methods and specifications, and for all regulatory compliance, labeling, marketing, licensure, and downstream use of the tested material; and
5.5 It will cooperate with reasonable requests for information, access, and clarification necessary for TrustPointe to perform.
6. Results and Reports
6.1 Scope of Results. Results, findings, and conclusions apply only to the specific Sample as received and to the specific method performed. They are not representative of any lot, batch, shipment, production run, or other material unless Client's own sampling plan makes them so, which is Client's responsibility to establish.
6.2 Report Issuance. TrustPointe will issue a Report on completion. Reports are issued to Client only. Draft or preliminary results are provisional and are superseded by the final Report.
6.3 Objections. Client must notify TrustPointe in writing of any objection to a Report, including any alleged error, omission, or nonconformity, within 10 days of issuance. Absent timely notice, the Report is deemed accepted.
6.4 Investigations and Retesting. Investigations of atypical, aberrant, or out-of-specification results, and any retesting requested by Client, are separately quoted and chargeable unless the result is attributable to TrustPointe's failure to perform in accordance with Section 3.1, in which case TrustPointe will re-perform the affected test at no charge as provided in Section 11.
6.5 Amendments. Amended Reports supersede prior versions and are identified as amended. Client will discontinue use of superseded Reports.
7. Use of Results; Publicity
7.1 Reproduction. Reports may be reproduced only in full. Client will not excerpt, abridge, redact, alter, or selectively disclose any portion of a Report, or present any result out of context, without TrustPointe's prior written consent.
7.2 No Endorsement or Marketing Use. Client will not use TrustPointe's name, logo, trademarks, accreditation marks, registration numbers, or the existence of the engagement in any advertising, marketing, packaging, label, website, social media, investor material, or public statement without TrustPointe's prior written consent in each instance. A Report is not an endorsement, certification, or approval of Client, Client's product, or any use of it.
7.3 Third-Party Reliance. Reports are prepared solely for Client's use. No third party is entitled to rely on a Report, and TrustPointe owes no duty to any third party. If Client provides a Report to a third party, Client does so at its own risk, will provide the Report in full, and will indemnify TrustPointe for any third-party claim arising from that disclosure.
7.4 Not for Diagnostic or Therapeutic Decisions. Results are not intended for use in human or veterinary diagnosis, treatment, or therapeutic decision-making, and are not a substitute for Client's own quality determination or batch release decision.
8. Regulatory Status
8.1 TrustPointe is an independent analytical laboratory. It is not a regulatory body and does not represent, act for, or speak on behalf of the FDA, DEA, EPA, USDA, or any other governmental authority. Nothing in the Services or any Report constitutes regulatory approval, clearance, product certification, or an endorsement of any specific use.
8.2 TrustPointe does not provide medical, clinical, legal, or regulatory consulting advice.
8.3 Accreditation and Registration. Any statement regarding accreditation, registration, or certification held by TrustPointe applies only to the specific scope for which it is granted and only during its term. Client is responsible for confirming that the Services fall within any scope on which Client intends to rely.
8.4 Batch Release. Except where a signed Quality Agreement expressly provides otherwise, TrustPointe does not perform batch release, does not act as Client's quality unit, and makes no disposition decision. Where TrustPointe reports conformance to a specification supplied by Client, that report is a statement of the analytical result against the stated criterion only, and Client retains sole responsibility for the release decision.
9. Fees, Invoicing, and Payment
9.1 Prices are those in the accepted Quote. Quotes are valid 30 days unless stated otherwise.
9.2 Payment terms are net 30 days from invoice date unless the Quote states otherwise. TrustPointe may require prepayment, a deposit, or a credit application for new or delinquent accounts.
9.3 Past-due amounts accrue a late charge of 2% per month or the maximum rate permitted by Michigan law, whichever is less. Client will reimburse TrustPointe's reasonable costs of collection, including attorneys' fees.
9.4 TrustPointe may suspend Services, withhold Reports, and decline new Samples while any amount is past due. Withholding under this Section is not a breach.
9.5 Fees exclude taxes, duties, shipping, and disposal costs, which are Client's responsibility. Prices exclude any tax on TrustPointe's net income.
9.6 Cancellation. If Client cancels Services after work has begun, Client will pay for work performed and non-cancellable costs incurred through the cancellation date, plus 10% of the remaining Quote value as a cancellation charge.
9.7 No Setoff. Client will pay invoiced amounts without setoff, deduction, or withholding.
10. Warranty and Disclaimer
10.1 Limited Warranty. TrustPointe warrants that the Services will be performed in accordance with Section 3.1 and the method specified in the Quote. This warranty runs for 30 days from Report issuance.
10.2 Exclusive Remedy. Client's sole and exclusive remedy, and TrustPointe's entire liability, for breach of the warranty in Section 10.1 is, at TrustPointe's option: (a) re-performance of the nonconforming test on retained or newly supplied Sample material; or (b) refund of the fees paid for the nonconforming test.
10.3 DISCLAIMER. EXCEPT AS EXPRESSLY STATED IN SECTION 10.1, THE SERVICES AND ALL REPORTS ARE PROVIDED "AS IS." TRUSTPOINTE DISCLAIMS ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, ACCURACY, AND NON-INFRINGEMENT. TRUSTPOINTE DOES NOT WARRANT THAT RESULTS WILL BE ERROR-FREE, THAT ANY SAMPLE IS SAFE, EFFECTIVE, PURE, POTENT, STERILE, OR COMPLIANT WITH ANY LAW OR STANDARD, OR THAT ANY REPORT WILL BE ACCEPTED BY ANY REGULATOR, CUSTOMER, OR THIRD PARTY.
11. Limitation of Liability
11.1 Exclusion of Indirect Damages. TO THE FULLEST EXTENT PERMITTED BY LAW, TRUSTPOINTE WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, OR FOR LOST PROFITS, LOST REVENUE, LOST DATA, BUSINESS INTERRUPTION, PRODUCT RECALL, DESTRUCTION OR LOSS OF PRODUCT OR SAMPLE, REGULATORY PENALTIES, OR REPUTATIONAL HARM, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY, EVEN IF ADVISED OF THE POSSIBILITY.
11.2 Cap. TRUSTPOINTE'S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO THE SERVICES, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, WARRANTY, INDEMNITY, OR OTHERWISE, WILL NOT EXCEED THE AMOUNTS ACTUALLY PAID BY CLIENT TO TRUSTPOINTE FOR THE SPECIFIC SERVICES GIVING RISE TO THE CLAIM.
11.3 Sample Value. TrustPointe's liability for loss of or damage to any Sample is limited to the cost of the raw material, and expressly excludes the value of the finished product, the batch from which it was drawn, or any development cost.
11.4 Allocation of Risk. Client acknowledges that the fees for the Services reflect this allocation of risk, that Client is in a better position to evaluate and insure against the risks of its own products, and that TrustPointe would not provide the Services on these prices absent these limitations. These limitations apply notwithstanding the failure of essential purpose of any limited remedy.
11.5 Time Bar. Any claim against TrustPointe must be brought within one (1) year after the date the Report giving rise to the claim was issued, or it is permanently barred.
11.6 These limitations do not apply to liability that cannot be limited under applicable law.
12. Indemnification
12.1 By Client. Client will defend, indemnify, and hold harmless TrustPointe and its members, officers, directors, employees, affiliates, subcontractors, and agents from and against any and all third-party claims, demands, actions, damages, losses, liabilities, penalties, costs, and expenses (including reasonable attorneys' fees) arising out of or relating to: (a) Client's use, interpretation, distribution, or publication of any Report or result; (b) any claim that Client's material or product caused injury, illness, death, property damage, or non-compliance; (c) any Sample, including hazardous, misbranded, adulterated, or undisclosed material; (d) Client's breach of these Terms or of any representation in Section 5; (e) Client's violation of law or of any third party's intellectual property rights; and (f) reliance on a Report by any third party.
12.2 Scope. This indemnity applies to claims alleging TrustPointe's own negligence, except to the extent a claim is finally determined to have been caused by TrustPointe's gross negligence or willful misconduct.
12.3 Procedure. TrustPointe will notify Client of any claim and may participate in the defense with its own counsel at its expense. Client will not settle any claim in a manner that imposes obligations on or admits fault by TrustPointe without TrustPointe's written consent.
12.4 Client's indemnity obligations are not subject to the limitations in Section 11.
13. Insurance
Client will maintain, at its own expense, commercial general liability and products liability insurance with limits of not less than $1,000,000 per occurrence / $2,000,000 aggregate, and will furnish a certificate of insurance on request.
14. Confidentiality
14.1 Obligation. Each Party will protect the other's non-public, proprietary, or confidential information with at least reasonable care, use it only to perform or receive the Services, and disclose it only to personnel, advisors, and subcontractors with a need to know who are bound by comparable obligations.
14.2 Exclusions. Confidential information does not include information that: (a) is or becomes public without breach; (b) was known to the receiving Party without obligation before disclosure; (c) is received from a third party without restriction; or (d) is independently developed without use of the disclosing Party's information.
14.3 Compelled Disclosure. A Party may disclose confidential information as required by law, subpoena, court order, or governmental or regulatory authority, and will, where legally permitted, give reasonable advance notice so the other Party may seek protective relief.
14.4 Client Data. TrustPointe will not disclose Client-specific results to third parties without Client's written consent, except as permitted in Section 14.3 or as reasonably necessary to defend a claim.
14.5 Residuals and Aggregate Data. Nothing restricts TrustPointe's use of general knowledge, skills, techniques, and experience retained by its personnel, or its use of de-identified and aggregated data that does not identify Client or Client's products.
14.6 Term. Obligations under this Section continue for 5 years after disclosure, and indefinitely for trade secrets.
15. Intellectual Property; Records
15.1 TrustPointe IP. TrustPointe exclusively owns and retains all rights in its methods, procedures, SOPs, validation and qualification data, software, templates, know-how, and all improvements to them, including any developed or refined in the course of the Services. No license is granted except the right to use the Report as permitted in Section 7.
15.2 Client IP. Client retains ownership of Samples, Client-supplied specifications, and Client confidential information. No license is granted to TrustPointe except as necessary to perform the Services.
15.3 Method Development. Where the Quote covers method development or transfer, ownership of the resulting method will be as stated in that Quote. Absent a written statement, TrustPointe owns the method and grants Client a non-exclusive, non-transferable license to use it for the product identified in the Quote.
15.4 Records. TrustPointe will retain Raw Data and Report copies for 5 years and may thereafter dispose of them. Copies of Raw Data are available to Client on written request at TrustPointe's then-current rates.
16. Audits and Regulatory Inspections
16.1 Client Audits. Client may conduct a supplier qualification audit of TrustPointe's facility no more than once per 12 months, on at least 30 days' written notice, during normal business hours, subject to TrustPointe's site, safety, and confidentiality requirements, and limited to areas and records relevant to Client's work. Additional or for-cause audits are subject to TrustPointe's then-current audit fee. Audits do not extend to other clients' data, proprietary methods, or financial records.
16.2 Regulatory Inspections. If a regulatory authority inspects TrustPointe in a manner that specifically implicates Client's Samples or Reports, TrustPointe will notify Client promptly to the extent legally permitted. TrustPointe may disclose information required by the authority without Client consent.
17. Term, Suspension, and Termination
17.1 These Terms apply from acceptance until all Services are complete, and continue to govern each subsequent submission.
17.2 For Cause. Either Party may terminate on written notice if the other materially breaches and fails to cure within thirty (30) days of written notice.
17.3 Immediate. TrustPointe may suspend or terminate immediately on written notice if: (a) Client is more than 45 days past due; (b) Client submits undisclosed hazardous or unlawful material; (c) Client breaches Section 7; or (d) Client becomes insolvent, makes an assignment for the benefit of creditors, or has a bankruptcy proceeding commenced against it.
17.4 For Convenience. Either Party may terminate for convenience on 30 days' written notice, subject to Section 9.6.
17.5 Effect. All fees for Services performed through termination remain due. Client will arrange for retrieval or disposal of Samples within 30 days, after which Section 4.6 applies.
17.6 Survival. Sections 4.2, 4.6, 5, 6.3, 7, 8, 9, 10.3, 11, 12, 13, 14, 15, 17.5, 17.6, 18, 19, 20, 21, and 22 survive termination.
18. Force Majeure
Neither Party is liable for delay or failure in performance (other than payment obligations) caused by events beyond its reasonable control, including natural disaster, fire, flood, severe weather, utility or instrument failure, epidemic or pandemic, labor disruption, war, terrorism, cyberattack, supply chain interruption, unavailability of reagents or reference standards, or governmental action. The affected Party will give prompt notice and use reasonable efforts to resume. If the event continues more than 60 days, either Party may terminate the affected Services without liability.
19. Non-Solicitation
During the engagement and for 12 months afterward, Client will not directly or indirectly solicit for employment or hire any TrustPointe employee involved in the Services, except through a general public advertisement not targeted at TrustPointe personnel.
20. Assignment
Client may not assign or transfer these Terms or any rights under them, by operation of law or otherwise, without TrustPointe's prior written consent. TrustPointe may assign these Terms in whole or in part, without Client's consent, to an affiliate or in connection with a merger, reorganization, change of control, or sale of all or substantially all of its assets or membership interests. These Terms bind and benefit the Parties' permitted successors and assigns.
21. Notices
Notices must be in writing and are effective on delivery when sent to the addresses on the most recent Quote or invoice by personal delivery, nationally recognized courier, certified mail, or email with confirmation of receipt. Notices to TrustPointe must be sent to 1743 142nd Ave Suite 4, Dorr, MI 49323 and email at trustpointe.com. Routine operational communications may be exchanged by email.
22. Governing Law and Disputes
22.1 These Terms are governed by the laws of the State of Michigan, without regard to conflict of law principles. The U.N. Convention on Contracts for the International Sale of Goods does not apply.
22.2 Venue. The Parties submit to the exclusive jurisdiction and venue of the state and federal courts located in Allegan County, Michigan, and waive any objection based on inconvenient forum.
22.3 JURY WAIVER. EACH PARTY KNOWINGLY AND VOLUNTARILY WAIVES ANY RIGHT TO TRIAL BY JURY IN ANY ACTION ARISING OUT OF OR RELATING TO THESE TERMS OR THE SERVICES.
22.4 No Class Actions. Claims must be brought individually and not as a plaintiff or class member in any purported class or representative proceeding.
22.6 Equitable Relief. Either Party may seek injunctive relief in any court of competent jurisdiction to protect confidential information or intellectual property without posting bond.
23. General
23.1 Independent Contractors. The Parties are independent contractors. Nothing creates a partnership, joint venture, agency, or employment relationship.
23.2 No Third-Party Beneficiaries. These Terms benefit only the Parties and their permitted successors. Section 12 also benefits the indemnified persons named there.
23.3 Severability. If any provision is held unenforceable, it will be modified to the minimum extent necessary to be enforceable, or severed, and the remainder continues in force.
23.4 Waiver. No waiver is effective unless in writing and signed. No failure or delay in exercising a right waives it.
23.5 Amendment. Except as provided in Section 2.2, these Terms may be amended only by a writing signed by both Parties.
23.6 Electronic Signatures. Electronic signatures and electronically transmitted copies have the same effect as originals.
23.7 Headings. Headings are for convenience only and do not affect interpretation.
23.8 Construction. These Terms will not be construed against either Party as drafter.
23.9 Entire Agreement. These Terms, together with the accepted Quote and any Addendum or signed Quality Agreement, constitute the entire agreement and supersede all prior or contemporaneous agreements, proposals, and representations, written or oral, on this subject.
Addendum A — cGMP Analytical Testing Services
Applies where the Quote designates the Services as cGMP, compendial release, or stability testing — including testing supporting 503A/503B compounding operations.
A.1 TrustPointe will perform the designated Services in accordance with applicable cGMP requirements and the compendial or validated method identified in the Quote.
A.2 Where the Quote or a Quality Agreement so provides, TrustPointe will report conformance of the analytical result to the specification supplied by Client. Such reporting is a statement of analytical outcome only and is not a batch release, disposition, or approval decision, which remain Client's sole responsibility as the entity holding the quality unit.
A.3 TrustPointe will handle out-of-specification results in accordance with its written OOS procedure and applicable FDA guidance and will notify Client within 3 business days of confirming an OOS result.
A.4 Change control affecting methods, instruments, or facilities used for Client's testing will be managed under TrustPointe's change control procedure. Notification obligations to Client, if any, are governed by a signed Quality Agreement.
A.5 Sections 3.2, 6, 7, 8, and 10 apply to Addendum A Services except where a signed Quality Agreement expressly provides otherwise.
Addendum B — Research Use Only Services
Applies where the Quote designates the Services as research use only (RUO), method development, exploratory, or non-GMP.
B.1 RUO Services are performed for research and informational purposes only. Methods may be unvalidated or partially validated as stated in the Quote.
B.2 RUO results are not suitable for lot release, stability programs, regulatory submission, or any decision affecting product distributed for human or animal use. Client will not represent RUO results as GMP, compendial, or accredited results.
B.3 Reports for RUO Services will be marked "Research Use Only — Not for Release Testing."
B.4 The disclaimers and limitations in Sections 10, 11, and 12 apply with full force to RUO Services.