Terms of Service

1. The agreement, and what is in it

The agreement between us is made up of, in descending order of precedence where they conflict:

1. an executed Order Form, quote or statement of work;
2. the Data Processing Addendum, where the Customer's Workspace will hold personal data;
3. the Service Level Agreement, where the Order Form incorporates it;
4. these Terms.

An Order Form may vary these Terms for that Customer. Nothing else does — a purchase order, a vendor questionnaire response or an email exchange adds no terms unless we countersign it.

Acceptance. A Customer accepts these Terms by executing an Order Form, by creating a Workspace through the signup flow, or by using the Service. A person accepting on behalf of an organisation warrants that they may bind it.

2. Definitions

3. The right to use the Service

We grant the Customer a non-exclusive, non-transferable, non-sublicensable right, for the Subscription Term, to access and use the Service for its own internal research, laboratory and business purposes, for up to the number of Authorised Users recorded on the Order Form.

The Service is provided as software as a service. No copy of the software is delivered, and nothing in these Terms transfers a licence to any part of it.

We may change the Service. We develop the Service continuously and may add, modify, deprecate or remove features. We will not materially reduce the core functionality of a Package during a term the Customer has paid for; subject to that, changes are at our discretion and no particular feature, interface or integration is guaranteed to persist. Where we deprecate a materially used feature, we will give reasonable notice.

Preview features. We may make a feature available and identify it as preview, early access or experimental. Using one is optional. A preview feature is provided "as is", is excluded from the warranties in §12, from the Service Level Agreement and from our indemnity in §13, may be changed or withdrawn at any time without liability, and should not be relied on for a record the Customer is required to retain.

Affiliates. A Customer affiliate may use the Service only if the Order Form names it. The Customer remains responsible for every affiliate's and User's acts and omissions as if they were its own.

4. Subscription, fees and renewal

Term. The Subscription Term is stated on the Order Form and, unless that Order Form says otherwise, runs for twelve months from the start date.

Renewal. The Subscription Term renews automatically for successive periods of the same length unless either party gives written notice of non-renewal at least 30 days before the current term ends.

Fees. Fees are those on the Order Form. TraceVial is sold as an annual subscription per Workspace, not per seat: a seat count below the Package cap does not reduce the fee. Fees are invoiced annually in advance unless the Order Form provides otherwise, payable within 30 days of the invoice date, in USD, without set-off.

No self-service card payment. Subscriptions are agreed with a person at TraceVial and invoiced. Nothing in the product takes a payment, and no plan change happens automatically on the strength of a request made in the application — a request raised in-product is a record that a human works through, not an instruction the system acts on.

Price changes at renewal. We may change the fees for a renewal term by giving notice at least 30 days before the renewal date. The Customer's remedy, if it does not accept the change, is not to renew.

Taxes. Fees exclude VAT, GST, sales and withholding taxes, which are the Customer's responsibility other than taxes on our income.

Late payment. Overdue amounts carry interest at 1.5% per month or the maximum permitted by law, whichever is lower. We may suspend under §5 for non-payment after giving notice and a reasonable opportunity to cure.

Non-refundable. Fees are non-refundable except where these Terms expressly say otherwise (termination for our uncured material breach, under §13) or where the law requires a refund.

5. Quotas, and what a lapsed subscription can still do

Quotas gate creation only. A Workspace that reaches a cap can no longer create records of that kind. It never loses records it already holds, nothing is hidden, and reading and exporting continue. The same is true of a downgrade that leaves a Workspace above a cap: it becomes read-only for that record type and keeps everything.

Lapse and suspension leave the record intact. If a subscription expires, or we suspend it under this section, the Workspace collapses to read-only: quotas resolve to zero and optional capabilities are switched off, so nothing new can be created. Customer Data is not deleted by a lapse or a suspension. Deletion happens only under §14.

There is no free trial period built into a paid subscription. A trial is its own Package with its own end date; a trial and a paid subscription both end on the date recorded for them.

We may suspend a Workspace, or a User's access, where: fees are overdue and notice has been given; use breaches §6 and continues after notice, or is serious enough that waiting would cause harm; or a Workspace is being used in a way that threatens the security, integrity or availability of the Service for others. We will limit a suspension to what the circumstances require and restore access promptly once the cause is resolved.

6. Acceptable use

The Customer will not, and will not permit anyone to:

Misuse the Service

• use the Service other than as these Terms permit, or for the benefit of anyone who is not an Authorised User or an affiliate named on the Order Form;
• resell, sublicense, rent, or provide the Service as a service bureau to a third party;
• share credentials between individuals, or let one credential stand for more than one person — every audit and signature record in the Service names an individual, and a shared credential destroys that;
• exceed, disable, circumvent or obscure a Quota or an entitlement check.

Attack or degrade it

• probe, scan or test the vulnerability of the Service, or breach or circumvent any authentication, rate limit or access control, except under a written authorisation we have given in advance — see the disclosure address at support@tracevial.com;
• interfere with or disrupt the Service or the infrastructure it runs on, including denial-of-service attacks and anything that imposes an unreasonable load;
• upload or transmit malicious code;
• scrape, crawl, or use automated means to extract data from the Service at a scale or rate the documented API and export features do not provide for. Ordinary use of the documented API, the MCP connector and the export features is not scraping.

Take the software apart

• reverse engineer, decompile or disassemble any part of the Service, or attempt to derive its source code, except to the extent applicable law expressly permits despite this restriction;
• copy, modify or create derivative works of the Service;
• use the Service to build a competing product, or benchmark it for publication without our written consent;
• remove or obscure a proprietary notice.

Put unlawful content into it

• upload Customer Data the Customer has no right to upload, or whose upload breaches a law, a donor's consent, an ethics approval or a third party's rights;
• use the Service in breach of export control or sanctions law, or make it available to a person or in a country that those laws prohibit.

We may investigate a suspected breach of this section, and the Customer will cooperate. Reporting a breach you become aware of, promptly, is itself an obligation of this section.

7. What the Customer is responsible for

This section is the one a generic SaaS contract does not carry, and it exists because TraceVial holds records about human biological material.

Consent, ethics and lawful basis. The Customer is solely responsible for obtaining and maintaining every consent, ethical approval, institutional review board approval, material transfer agreement, licence and lawful basis needed for it to collect, hold and process the specimens, donors' data and research data it puts into its Workspace, and for honouring any withdrawal of consent. TraceVial has no relationship with a donor, no visibility of a consent form, and no means to judge whether a record should exist.

Minimise what identifies a person. The Service is designed for pseudonymised specimen records. The Customer decides what goes into a free-text field, an attribute or an uploaded file, and should not place directly identifying donor or patient information in a Workspace unless it has to.

Protected health information. Unless an executed Business Associate Agreement says otherwise, the Customer must not put information subject to HIPAA that exceeds a limited data set into the Service.

Research use. The Service is laboratory and research management software. It is not a medical device, is not cleared or approved by any regulator as one, and must not be used to diagnose, treat, prevent or mitigate disease, or as the sole basis of a clinical decision about an individual. Where the Customer uses it in a regulated process, the Customer is responsible for that process.

21 CFR Part 11 is shared, and the split matters. TraceVial supplies the technical controls — attributable and time-stamped audit records, user authentication, a signing step that captures the signer, the time, the meaning of the signature and the record it applies to, and integrity checking over signed records. Everything else is the Customer's: the standard operating procedures, the training records, the signature-to-record linkage policy, the certification to the FDA that electronic signatures are the legally binding equivalent of handwritten ones, the periodic review of audit trails, and validating the system for its intended use in the Customer's own environment. We will supply the documentation a validation effort reasonably needs. We do not validate the Customer's installation, and a claim by us that the product supports Part 11 is not a claim that the Customer's use of it is compliant.

Accounts and credentials. The Customer is responsible for the confidentiality of its Users' credentials and signing PINs, for deactivating a User who leaves, and for everything done through its Users' accounts. Tell us at support@tracevial.com as soon as the Customer suspects a credential has been compromised.

The Customer's own copies. The Service is not a backup service and is not a substitute for the Customer's own records management. The Customer is responsible for determining whether the Service's availability and backup posture, as described in the Service Level Agreement, meets its own legal, regulatory and operational retention obligations, and for maintaining independent copies of anything it cannot afford to lose where it does not.

Accuracy. We do not review Customer Data for accuracy, completeness, legality or fitness for any purpose.

8. Intellectual property

We own the Service. TraceVial and its licensors own all right, title and interest in the Service: the software, its interfaces, its data models, the documentation, and every improvement to them. These Terms grant a right of access, not an assignment, and all rights not expressly granted are reserved.

The Customer owns Customer Data. The Customer and its licensors retain all right, title and interest in Customer Data. We claim none.

The licence we need to run the Service. The Customer grants us a non-exclusive, worldwide, royalty-free licence to host, copy, transmit, display and process Customer Data solely to provide, secure, support and maintain the Service for that Customer, and as its Users instruct through the product. It ends when the data is deleted under §14.

Feedback. If the Customer or a User gives us suggestions about the Service, we may use them without restriction or obligation. Feedback is not Customer Data and should not contain any.

De-identified and aggregated data. We may generate data about how the Service is used that is aggregated across customers and de-identified so that it cannot reasonably be used to identify the Customer, a User, a donor or a specimen, and use it to operate, secure, support and improve the Service and to report on the Service's usage in aggregate. We do not use Customer Data to train machine learning models, and we do not disclose de-identified data in a form that identifies the Customer as its source.

9. Third-party services the Customer chooses to connect

The Service can be connected to third-party services at the Customer's option — an identity provider for single sign-on, and AI assistants through the MCP connector.

The connector sends Customer Data to a provider the Customer picks. When a User authorises an AI assistant through the MCP connector, that assistant's provider receives the data the User's questions cause the connector to return. Write-enabled tools are off unless a Workspace opts in. That provider is the Customer's supplier, not ours: its terms and its privacy practices govern what it does with the data, we do not control them, and we are not responsible for them. The Customer is responsible for deciding which assistants its Users may connect and on what terms.

Every one of these connections is the Customer's decision, made by its own administrator. We are not responsible for a third-party service's availability, security or acts.

10. Confidentiality

Each party will protect the other's Confidential Information with at least reasonable care, use it only to perform under this agreement, and disclose it only to people who need it and are bound by equivalent obligations. Customer Data is the Customer's Confidential Information. The Service's non-public features, documentation, security materials and pricing are ours.

The obligation does not apply to information that is or becomes public without breach, was already known free of obligation, is independently developed, or is rightfully received from a third party. A party compelled by law to disclose may do so, after giving the other reasonable notice where it is lawfully able to.

11. Security, privacy and data protection

We maintain the technical and organisational measures described in the DPA, Annex II.

Where a Workspace holds personal data, the DPA applies and, to the extent it conflicts with these Terms on the processing of personal data, it prevails. Our handling of personal data we determine the purposes of is described in the Privacy Policy.

12. Warranties, and what we do not warrant

We warrant that: we have the right to grant the rights in §3; the Service will perform materially in accordance with the documentation we publish for it; we will provide the Service with reasonable skill and care; and we will not knowingly introduce malicious code into it.

The remedy for a breach of the performance warranty is for us to correct the Service within a reasonable period after the Customer's written notice, and if we cannot, for the Customer to terminate the affected subscription and receive a pro-rata refund of prepaid fees for the remainder of the term. Availability is dealt with by the SLA, whose service credits are the sole remedy for a missed availability commitment.

Otherwise, to the maximum extent the law allows, the Service is provided "as is". We disclaim all other warranties, express or implied, including merchantability, fitness for a particular purpose and non-infringement. We do not warrant that the Service will be uninterrupted or error-free, that it will meet a regulatory requirement that applies to the Customer, or that Customer Data will never be lost or corrupted — the Customer is responsible for judging whether the Service's backup and availability posture is sufficient for its own records-retention obligations, and for keeping its own copies where it is not.

We do not warrant that the Service is validated for any regulated use. Validation is performed by the Customer, for the Customer's intended use, in the Customer's own environment — §7.

The warranties in this section do not apply to a preview feature (§3), to a Package or feature provided free of charge, or to use of the Service other than as these Terms permit.

The Customer is responsible for satisfying itself that the Service is suitable for its purposes before committing a process to it. We make the Service available for evaluation before a subscription begins for that reason.

13. Indemnities

We will defend the Customer against a third-party claim that the Service, used as permitted, infringes that party's patent, copyright, trademark or trade secret, and pay damages finally awarded or amounts we agree in settlement. If the Service becomes, or we think it may become, the subject of such a claim, we may procure the right to continue using it, modify it so it is non-infringing, or terminate the affected subscription and refund prepaid fees for the unused remainder of the term. This does not apply to a claim arising from Customer Data, from use in breach of these Terms, from modification by anyone other than us, or from combination with anything we did not supply.

The Customer will defend us against a third-party claim arising from Customer Data or from the Customer's use of the Service in breach of §6 or §7 — including a claim by a donor, a research participant, an ethics committee or a regulator about consent, approval or the lawfulness of holding a record — and pay damages finally awarded or amounts it agrees in settlement.

Each indemnity is conditioned on prompt notice, sole control of the defence by the indemnifying party (no settlement admitting fault or imposing an obligation on the other without consent), and reasonable cooperation.

Our indemnity is the Customer's sole and exclusive remedy for a claim that the Service infringes a third party's intellectual property rights, does not apply to a preview feature or to anything provided free of charge, and is subject to the cap in §15.

14. Term, termination and what happens to the data

Termination for cause. Either party may terminate for the other's material breach that is not cured within 30 days of written notice, or immediately if the other becomes insolvent or enters an equivalent proceeding.

Termination by us for convenience. We may terminate a subscription, or discontinue the Service or a Package, on at least 90 days' written notice, refunding prepaid fees for the unused remainder of the term. That refund, and the retrieval window below, are the Customer's sole remedy for such a termination.

On termination or expiry, the Customer's right to use the Service ends and any unpaid fees for the remainder of a term terminated by us for cause, or by the Customer without cause, fall due. Where the Customer terminates for our uncured material breach, we refund prepaid fees for the unused remainder of the term.

Retrieval window. For 30 days after termination or expiry we will, on the Customer's written request, make Customer Data available for retrieval, or supply an export of it in a machine-readable format.

Deletion. Once that window has closed we will delete Customer Data, including the Workspace's database schema and its file storage, within 60 days of termination or expiry. That period runs from the same date as the retrieval window, not from the day the window closes. Deletion excludes copies held in backups and in the snapshots we take before a deployment that changes the database schema, and anything we must retain by law. Backup copies are overwritten on the ordinary backup rotation; a snapshot is not on a rotation, so a copy may persist in one after the Workspace has gone. Both stay subject to the same confidentiality and security obligations for as long as they exist, and §12 of the Data Processing Addendum governs them where it applies. On the Customer's written request we will confirm deletion in writing.

Survival. §§2, 6, 7, 8, 10, 12 (the disclaimer), 13, 14, 15 and 16 survive.

15. Limitation of liability

No indirect loss. Neither party is liable for indirect, incidental, special, consequential or punitive damages, or for lost profits, lost revenue, lost goodwill, or loss or corruption of data beyond the cost of restoring it from the Customer's own backups, however caused and on any theory of liability, even if advised of the possibility.

The cap. Each party's total aggregate liability arising out of or related to this agreement is limited to the fees paid by the Customer in the twelve months preceding the first event giving rise to the claim.

One cap, across every document. That cap is a single aggregate limit across these Terms, the Order Form, the Service Level Agreement, the Data Processing Addendum, and every claim of any kind, whether in contract, tort (including negligence), statute or otherwise. Multiple claims do not enlarge it, and no document in the agreement carries a separate cap of its own. Service Credits already paid under the Service Level Agreement are set off against it. Where the Customer has paid nothing in that twelve-month period, the cap is USD 1,000.

What the cap does not cover. Nothing in this section limits liability for: death or personal injury caused by negligence; fraud or fraudulent misrepresentation; the Customer's obligation to pay fees; either party's indemnity obligations under §13; the Customer's breach of §6 (acceptable use) or §8 (our intellectual property); or anything that cannot be limited by law.

Time limit on claims. Neither party may bring a claim arising out of or related to this agreement more than twelve months after the party became aware, or ought reasonably to have become aware, of the facts giving rise to it, except for a claim for non-payment. This applies to the extent the law permits parties to agree a shorter limitation period.

The allocation is deliberate. The fees reflect this allocation of risk, the fees would be materially higher without it, and neither party would enter into the agreement on any other basis.

16. General

Changes to these Terms. We may update these Terms for a renewal term, on notice given at least 30 days before the renewal date. Changes that materially reduce the Customer's rights do not apply to a term already paid for. Where an Order Form incorporates a specific version, that version governs that term.

Notices are given in writing to the addresses on the Order Form, or for us to support@tracevial.com. Notice by email is effective when sent, absent a delivery failure.

Assignment. Neither party may assign without the other's consent, except to a successor in a merger, acquisition or sale of substantially all assets, on notice.

Force majeure. Neither party is liable for a failure caused by something beyond its reasonable control, other than an obligation to pay.

Publicity. Neither party may use the other's name or marks in publicity without written consent, except that a party may include the other in a factual list of customers or suppliers.

Subcontracting. We may use sub-processors and subcontractors as the DPA provides, and remain responsible for their performance.

Independent contractors. Nothing here creates a partnership, agency or employment relationship.

No third-party beneficiaries. This agreement is for the benefit of the parties and their permitted assigns only, and confers no right on anyone else — including a User, a research participant or a specimen donor — to enforce any of its terms.

No reliance. Each party agrees that in entering into this agreement it has not relied on any statement, representation, assurance or warranty that is not set out in it, including anything said in a demonstration, a roadmap discussion or a proposal. Nothing in this clause limits liability for fraudulent misrepresentation.

Severability and waiver. An unenforceable provision is modified to the minimum extent needed or severed, leaving the rest in force. A failure to enforce is not a waiver.

Entire agreement. These Terms and the documents in §1 are the entire agreement and supersede prior discussions.

Governing law and forum. This agreement is governed by the laws of Vietnam, without regard to conflict-of-laws rules, and the parties submit to the exclusive jurisdiction of the competent courts of Hanoi, Vietnam. The UN Convention on Contracts for the International Sale of Goods does not apply.

Contact. FUSION CELL COMPANY LIMITED, 27/147 Xuan Dinh Street, Xuan Tao Ward, Hanoi, Vietnam (Enterprise Registration No. 0111184391) — support@tracevial.com.