Version 2026-07-30 · Effective from 2026-07-30
Prodigident Australia Pty Ltd ATF Iatsukha Family Trust · ABN 79 527 142 251
Website: prodigident.com.au · Platform access terms: Portal Terms of Use

ProDigiDent Account & Services Agreement — Custom Manufacture of Implant Surgical Guides

Parties

This Account & Services Agreement is made between:

(1) Prodigident Australia Pty Ltd (ACN 639 377 067) as trustee for the Iatsukha Family Trust (ABN 79 527 142 251), trading as ProDigiDent, of U30, 18 Bourton Road, Merrimac, Queensland 4226, Australia ("ProDigiDent", "the Lab", "we", "us" or "our"); and

(2) the Customer — the dental practice, dental laboratory, or other organisation entity on whose behalf Cases are placed and which accepts this Agreement through an Authorised User, as identified when the Account is created ("the Customer", "the Client", "you" or "your").

Each is a Party and together the Parties.

Who bears the commercial obligations. The Customer is the contracting party and bears all commercial obligations under this Agreement — payment, credit, and the indemnity in clause 12.7 — and the Account (clause 1.1), the payment terms (clause 6.3), overdue blocking (clause 6.5) and account status (clause 14) all attach to the Customer. The Customer places Cases through its Authorised Users, who may include practice staff; but only a Practitioner (a treating registered dental practitioner) may give clinical Approval (clause 5.2). The Customer is responsible for the acts and omissions of its Authorised Users and Practitioners in connection with the Platform and each Case.

Sole-trader (degenerate) case. Where a Practitioner carries on practice in their own name and is not incorporated or otherwise separately constituted, the Customer and the treating Practitioner are the same person, and references to the Customer and to the Practitioner are read as references to that person in the corresponding capacity.

Authority to bind. The Authorised User who accepts this Agreement represents and warrants that they are authorised to bind the Customer to this Agreement, whether as the Customer's officer, employee or agent, and the Customer accepts that it is bound to the same extent as if this Agreement had been signed by its directors. Where the Customer is a company and the statutory conditions are satisfied, the Lab is also entitled to rely on the assumptions in sections 128–129 of the Corporations Act 2001 (Cth), under which the Lab may assume that a person held out by the company as an officer or agent has authority to do the acts customarily done in that role, unless the Lab actually knows or suspects otherwise. Where the Customer is not a company, or those statutory conditions are not satisfied, this contractual authority warranty carries the load and the Lab relies on it. Acceptance may be given by an individual as the Customer's agent under section 126 of that Act and does not require formal execution under section 127.

Trustee Customers. Where the Customer enters into this Agreement as trustee of a trust, it contracts in that capacity, gives the trustee-Customer representations in clause 13.4 in favour of the Lab, and is liable both personally and in its capacity as trustee.

Broad Client definition. "Customer"/"Client" is defined broadly (clause 1.1) and covers dental practitioners and dental practices, dental laboratories, and referring-doctor arrangements. Lab-specific terms may be added by a separate schedule in future; until then such Customers are bound by this Agreement.

This Account & Services Agreement governs the placing and fulfilment of individual Cases through the Platform. It is the successor to, and replaces, the practice-level Master Services Agreement version "2026-05" (the "business agreement" previously referenced at practice registration): it is accepted through the same acceptance ledger (the msa_acceptances record), as a new version, and once accepted it governs the Case-ordering relationship in place of that prior version (clause 2.6). Its order of precedence against the other documents is set by clause 2.5.

Recitals

A. The Lab operates a dental laboratory in Queensland, Australia — at the address stated in the Parties clause (U30, 18 Bourton Road, Merrimac, Queensland 4226, on the Gold Coast) — that manufactures implant surgical guides for registered dental practitioners. The Lab's place of performance is Merrimac, Gold Coast, Queensland (time zone Australia/Brisbane). A Surgical Guide is a personalised medical device made to order for the anatomy of an individual named patient (see clause 3 for its regulatory characterisation).

B. The Lab does not provide clinical or dental services and does not enter into any relationship with the patients of the Customer or its Practitioners. The treating Practitioner is at all times the treating clinician and retains sole responsibility for all clinical decisions.

C. Each Case proceeds through a defined lifecycle in two design stages. In stage 1 the Lab prepares a Treatment Plan — the proposed implant positions, nerve and anatomical marking, crown positions and the aligned and merged scan (STL) and DICOM data — which the treating Practitioner reviews and expressly approves (or which the Practitioner supplies as their own final plan), producing the Approved Plan. In stage 2 the Lab designs the physical guide itself (the Guide Design) to implement the Approved Plan and then manufactures it. It is the Practitioner's approval of the Treatment Plan (stage 1) that authorises manufacture; the design of the guide itself (stage 2) is the Lab's work product and is not subject to the Practitioner's approval (clause 5.7).

D. This Agreement is entered into between businesses. The Customer acquires the Lab's goods and services for the purpose of the Customer's dental practice, dental laboratory or referral business and not for personal, domestic or household use.

E. The Customer's acceptance is recorded electronically as described in clause 2, creating a durable evidentiary record of the version of this Agreement accepted, the accepting user, and the time of acceptance. Acceptance by this electronic method has effect under the Electronic Transactions (Queensland) Act 2001 (Qld) and the Electronic Transactions Act 1999 (Cth).

1. Definitions and interpretation

1.1 Definitions. In this Agreement:

"Account" means the account through which the Customer places Cases on the Platform, together with the commercial settings attached to it (including payment terms and any credit limit). The Account attaches to the Customer.
"ACL" means the Australian Consumer Law, being Schedule 2 to the Competition and Consumer Act 2010 (Cth).
"Approval" means the treating Practitioner's express electronic approval of the Treatment Plan for a Case through the Platform (or, on the alternative path in clause 5.7(b), the Practitioner's supply of their own final Treatment Plan), which authorises the Lab to design and manufacture the Surgical Guide implementing that plan. Approval is of the Treatment Plan (stage 1), not of the Guide Design (stage 2). Approval is described further in clause 5.
"Approved Plan" means the Treatment Plan as approved by the treating Practitioner (being the version approved), or a Practitioner-supplied final Treatment Plan under clause 5.7(b) — being the plan that the Lab's Guide Design implements and to which the Surgical Guide is manufactured.
"Authorised User" means an individual the Customer authorises to access the Account and to place and manage Cases on the Customer's behalf, whether a Practitioner or practice staff. Only a Practitioner may give Approval.
"Business Day" means a day that is not a Saturday, Sunday or public holiday in Queensland at the Gold Coast (the locality of the Lab's place of business), determined by reference to Queensland public holidays and any Gold Coast regional show-day holiday, in the Australia/Brisbane time zone.
"Case" means a single order for one or more Surgical Guides for a single named patient.
"Case Files" means the scans, DICOM data, intraoral scan data, images, prescriptions, instructions and other materials the Customer supplies to the Lab for a Case.
"Consumer Guarantee" means a guarantee that applies to the supply of goods or services under Division 1 of Part 3-2 of the ACL.
"Credit Application" means the separate credit-terms application and agreement described in clause 6.3, by which a Customer may apply for Net or EOM payment terms.
"Customer" or "Client" means the party identified in the Parties clause: the dental practice, dental laboratory or other organisation entity (or, in the sole-trader case, the individual Practitioner) that contracts with the Lab and bears the commercial obligations under this Agreement.
"Design File" means the CAD/CAM design and manufacturing files created by the Lab, including guide geometry, sleeve and support-structure design, and manufacturing set-up data, as distinct from the Practitioner Data from which they are derived. The Design Files embody the Guide Design (clause 5.7(c)).
"Fees" means the fees payable for the Lab's goods and services, calculated under clause 6.
"GST" has the meaning given in the A New Tax System (Goods and Services Tax) Act 1999 (Cth).
"Guide Design" means the Lab's stage-2 design of the physical Surgical Guide that implements the Approved Plan — including the design of the sleeves, anchor pins, guide body and support structures and the associated CAD/CAM manufacturing set-up (embodied in the Design Files) — being the Lab's own work product. The Guide Design is not subject to the Practitioner's approval (clause 5.7(c)); "the design of the guide" in the software's stage-2 (production-ready) phase is the Guide Design.
"Order Lifecycle" means the sequence of order statuses set out in clause 4.1.
"Planning and Revision Fee" or "PRF" means the planning and revision fee described in clauses 5.5 and 6.1, calculated under the Price List.
"Platform" means the ProDigiDent online portal and any associated systems through which Cases are placed, designs are prepared, Treatment Plans are reviewed and approved, and communications and records are maintained.
"Practitioner" means the treating registered dental practitioner responsible for the clinical decisions on a Case and for giving Approval. A Practitioner is an Authorised User.
"Practitioner Data" means the Case Files and any personal information (including patient health information) the Customer or its Practitioners supply to the Lab.
"Price List" means the Lab's published, versioned price list for design services, Surgical Guides and related items, as in force from time to time (each version identified and dated).
"Privacy Policy" means the ProDigiDent Privacy Policy published at prodigident.com.au/privacy, as updated from time to time.
"Surgical Guide" or "Guide" means an implant surgical guide manufactured by the Lab, being a custom-made or patient-matched medical device made to the anatomy of an individual named patient.
"TGA" means the Therapeutic Goods Administration.
"Treatment Plan" means the Lab's stage-1 digital planning for a Case — the proposed implant positions (placement, angulation and depth), nerve and anatomical marking, crown/prosthetic positions, and the aligned and merged intraoral-scan (STL) and DICOM data — prepared and presented to the treating Practitioner for review and Approval; or, on the alternative path in clause 5.7(b), the final plan the Practitioner supplies. The Treatment Plan is what the Practitioner approves (stage 1) and is distinct from the Guide Design (stage 2).
"Trust" means the Iatsukha Family Trust.

1.2 Interpretation.

(a) Headings are for convenience only and do not affect interpretation.

(b) The singular includes the plural and vice versa.

(d) A reference to "including" or "for example" is not limiting.

(e) The order of precedence between this Agreement, the Portal Terms of Use, the Price List, the Privacy Policy and any other document that makes up the arrangement between the Parties is governed by clause 2.5. The Privacy Policy governs the manner in which personal information is handled and any privacy notices, but does not reduce, override or vary a data-protection or confidentiality obligation expressly agreed in this Agreement.

1.3 B2B supply. The Customer acknowledges that the goods and services under this Agreement are of a kind ordinarily acquired for business use and are acquired by the Customer for the purpose of its dental practice, dental laboratory or referral business.

2. Acceptance, term and versions

2.1 How this Agreement is accepted. This Agreement takes effect when an Authorised User accepts it electronically on the Customer's behalf through the Platform (including at the practice-account creation step). At the point of acceptance the Platform records an acceptance event that captures, so far as the Platform reliably records and preserves them, the document identifier, a SHA-256 hash of the accepted content, the version, the UTC timestamp of acceptance, the accepting user's identifier, and (where captured) the IP address and user-agent. A durable, retrievable record of the exact content accepted is kept as evidence of what was accepted and when.

2.2 No retrospective effect. This Agreement applies only from the time it is accepted. It does not apply retrospectively and is not treated as accepted silently. Placeholder text previously shown in the Platform or on the website does not constitute a binding agreement.

2.2A Transition period — existing clients. During the transition to the Platform, the Lab may administer Cases for existing clients who have not yet registered on the Platform (including Cases the Lab enters on a client's behalf). Those Cases and clients remain governed by the Lab's Account Form (June 2024), comprising its Credit Terms and Conditions and Service Terms and Conditions, as signed by or provided to that client, or otherwise the terms established by the parties' course of dealing (the "legacy terms"), not by this Agreement. For each Case the Lab enters on a client's behalf during the transition, the Lab records on that Case which version of the legacy terms governs it. This Agreement binds a client only from the time an Authorised User accepts it under clause 2.1 following the client's own registration. The transition ends on a cut-off date announced by the Lab on at least 30 days' written notice to affected clients; from that cut-off date, new Cases are accepted only through the Platform under this Agreement.

2.3 New versions and re-acceptance. The Lab may issue a new version of this Agreement. The re-acceptance mechanism depends on the nature of the change:

(a) Material change — a change to pricing, fees, liability, payment terms, credit, intellectual property, or another term that materially and adversely affects the Customer: the Lab gives at least 30 days' written notice (by email and in the Platform) before the new version takes effect, presents the new version for review, and hard-blocks the placing of new Cases until the Customer accepts it. Where the Customer does not wish to accept a material change, it may close its Account without penalty by notice given before the new version takes effect (subject to accrued rights and Cases already in progress). A material change does not apply to the Customer until accepted.

(b) Minor change — a cosmetic, clarifying or non-adverse change: the Lab may present it by an in-Platform banner notice, and it takes effect on continued use, without hard-blocking.

Re-acceptance is recorded in the same way as in clause 2.1, and the Lab records which mechanism (material or minor) was used for each version.

2.3A Which version governs a Case. A Case is governed by the version of this Agreement most recently accepted by the Customer as at the time the Case is submitted (see clause 4.3). A version accepted after a Case has been submitted does not apply to that Case, except to the extent the change is required by law or the Parties expressly agree that the new version applies to that Case. This is the single rule for determining which version governs a Case, and it fixes the governing terms at submission so that a later version cannot alter an already-formed Case without agreement.

2.4 Term. This Agreement continues until terminated under clause 15. The version of this Agreement that governs any individual Case is determined solely under clause 2.3A.

2.5 Relationship with other agreements — order of precedence. This Agreement, the ProDigiDent Portal Terms of Use, the Price List, the Privacy Policy and any surviving practice-level or organisation-level agreement between the Lab and the Customer together record the arrangement between the Parties. If there is an inconsistency between them, they apply in the following order of precedence, a document higher in the list prevailing over a document lower in the list to the extent of the inconsistency:

(a) any term implied or required by law that cannot lawfully be excluded (including the Consumer Guarantees and the unfair-contract-terms provisions of the ACL);

(b) this Account & Services Agreement, in relation to the ordering, supply and manufacture of a Surgical Guide (a Case);

(d) the Price List that applies to the Case under clause 6.1, in relation to Fees;

(e) the Privacy Policy, in relation to privacy practices and privacy notices, provided that the Privacy Policy does not reduce, override or vary a data-protection or confidentiality obligation expressly agreed in this Agreement or the Portal Terms of Use; and

(f) any surviving practice-level or organisation-level agreement.

Where the same subject matter is dealt with both by this Agreement and by the Portal Terms of Use, the document dealing with that subject matter specifically prevails over the document dealing with it generally. This Account & Services Agreement is the master contract for Case-level matters; because it supersedes the practice-level MSA version "2026-05" (clause 2.6), item (f) is intended to apply only to any distinct practice- or organisation-level arrangement that survives alongside it, and then only for account/relationship matters. This order of precedence is stated identically in clause 3.5 of the Portal Terms of Use.

2.6 Succession from the practice-level MSA. This Agreement is the official successor to the practice-level Master Services Agreement version "2026-05". On acceptance of this Agreement by or for a Customer, this Agreement governs the Case-ordering relationship in place of that prior version. Acceptances are recorded in the same acceptance ledger as a new version, so the continuity of the Customer's acceptance history is preserved. Cases already in progress under the prior version continue under the terms on which they were formed; this Agreement governs Cases submitted after its acceptance.

3. Nature of the goods and regulatory status

3.1 Personalised medical device. A Surgical Guide is a personalised medical device manufactured to the anatomy of a specific named patient, its Guide Design implementing the Approved Plan. The Lab manufactures each Surgical Guide under the TGA's personalised medical device framework, as either a custom-made medical device or a patient-matched medical device, according to the classification that applies to the device under current TGA guidance. The Lab supplies each Surgical Guide under the regulatory pathway actually available to it for that classification, which may include:

(a) for a patient-matched medical device, the transitional exemption from ARTG inclusion available for patient-matched medical devices until 1 July 2029, and (where its conditions are met) the low-volume exemption for the first units of a kind supplied in a financial year; or

(b) for a custom-made medical device, the custom-made medical device exemption from ARTG inclusion.

The Lab does not represent that a Surgical Guide is presently included in the ARTG unless and until such inclusion is in fact obtained. Exemption from ARTG inclusion is not exemption from regulation: the Lab remains subject to the Essential Principles and to applicable advertising and manufacturing requirements.

3.2 No overstated regulatory claims. The Lab does not represent, and the Customer and its Practitioners must not represent, that a Surgical Guide is "TGA approved" or carries any TGA endorsement. Neither ARTG inclusion nor exemption from ARTG inclusion (as applicable to the device) is an endorsement or approval of the device by the TGA, and neither must be represented as such.

3.3 Essential Principles and manufacturer's documentation. The Lab designs and manufactures each Surgical Guide with the objective of conformity with the applicable Essential Principles for safety and performance. The Lab is implementing, and undertakes to develop and maintain, documented conformity, traceability and record-retention processes for the Surgical Guides it supplies; the Lab does not warrant that fully documented systems are already in operation for every Guide as at the date of this version, and is building those systems as part of its regulatory roadmap. The written documentation the Lab provides depends on the applicable regulatory pathway:

(a) Custom-made medical device. Where a Surgical Guide is a custom-made medical device, the Lab supplies a written statement with the device (accompanying the device on supply). The statement identifies the device and the named patient (which may be by reference to the treating health professional), explains how the device complies with the Essential Principles (or, where it does not fully comply, identifies the requirements not met and the reasons), and is signed and dated by a person authorised by the Lab, stating that person's name and position.

(b) Patient-matched medical device. Where a Surgical Guide is a patient-matched medical device, the Lab maintains and, on the Practitioner's request, provides the manufacturer's documentation required for that pathway, identifying the device and intended patient, the manufacturer's name and address, and how the device complies with the Essential Principles.

The Lab retains conformity and traceability records as they are established, and in any event as required by law.

3.4 Single patient. Each Surgical Guide is intended only for the named patient for whom it was ordered and must not be used for any other patient.

3.5 Device safety, incidents and recalls. The Parties will cooperate on matters affecting the safety of a supplied Surgical Guide:

(a) each Party will promptly notify the other on becoming aware of a suspected device deficiency, adverse event, or complaint involving a supplied Surgical Guide, and of any regulator enquiry relating to it;

(b) the Customer will preserve, and provide to the Lab on reasonable request, information reasonably needed to investigate such a matter (including the affected Guide where practicable), and the Lab will investigate and keep the Customer reasonably informed;

(c) where a recall, safety alert or other corrective action is required for a supplied Surgical Guide, the Lab will conduct it in accordance with its regulatory obligations and the Customer will provide reasonable assistance, including passing on safety information relevant to the affected patient; and

(d) each Party bears the costs of a safety or corrective action to the extent the matter is attributable to its own act, omission or breach.

Nothing in this clause requires a Party to act inconsistently with its own legal or professional reporting obligations, and it does not limit either Party's mandatory reporting duties to the TGA or another regulator.

4. Ordering and the Order Lifecycle

4.1 Order Lifecycle. A Case may pass through the following statuses in the Platform:

draft → submitted → awaiting_payment → pending_files → pending_instructions → not_verified → designing → pending_approval → revision_requested → approved → in_production → shipped → completed

These are the possible states of a Case, not a strictly linear sequence. A Case may skip states that do not apply to it, may revisit states (for example through the revision loop pending_approval → revision_requested → designing → pending_approval), and, for account (Net) terms, may reach awaiting_payment after shipped. The actual transitions are governed by the operative terms of this Agreement (in particular clauses 5, 6.3 and 6.4), not by the order in which the statuses are listed.

4.2 What the statuses mean. In summary:

(a) draft / submitted — the Customer is preparing or has lodged the Case.

(b) awaiting_payment — where prepayment applies, payment is required before the Case proceeds past the applicable gate (see clause 6).

(d) not_verified — the Lab is verifying the supplied files are complete and usable.

(e) designing — the Lab is preparing the Treatment Plan for the Practitioner's review (stage 1) and, after Approval, the Guide Design that implements it (stage 2).

(f) pending_approval — a Treatment Plan has been published to the Practitioner for review and Approval.

(g) revision_requested — the Practitioner has asked for changes to the plan and the Case returns to planning.

(h) approved — the treating Practitioner has approved the Treatment Plan (the Approved Plan); this authorises manufacture.

(i) in_production — the Lab is manufacturing the Surgical Guide, its Guide Design implementing the Approved Plan.

(j) shipped — the Guide has been dispatched by courier.

(k) completed — the Case is finalised.

4.3 Contract formation for a Case. Formation of the contract for a Case occurs in two stages, and the no-cancellation event is defined once:

(a) Offer. Submitting a Case is the Customer's offer to acquire planning and design services and, subject to Approval of the Treatment Plan, the manufacture of a Surgical Guide, on the version of this Agreement that governs the Case under clause 2.3A. Submission alone does not bind the Lab. The price shown at submission is a preliminary estimate only, based on the configuration the Customer declares in the Case (arch, sites, guide type and package); the final Fees reflect the actual Approved Plan and are determined under clause 6.1.

(b) Acceptance of the Case (planning stage). The Lab accepts the Case, and a contract for the Case is formed on this Agreement, when the Lab first commences planning/design work on the Case (stage 1) — objectively evidenced by the Case moving to the designing status in the Platform — or when the Lab otherwise notifies the Customer that it accepts the Case, whichever is earlier. Before that point the Lab may decline the Case (for example for unusable files or lack of capacity), and no charge arises.

(c) Commitment to manufacture. Approval authorises manufacture. The Lab commits to manufacture when, following Approval, cleared payment has been received where prepayment applies (clause 6.3(a)) and the Lab commences manufacture. Before manufacture commences, the Lab may decline to commence manufacture of an approved Case (for example for a patient-safety, regulatory or non-payment reason), in which case clause 4.3(e) applies.

(d) No-cancellation event. The single no-cancellation event for a Case is the commencement of manufacture (the Case moving to in_production). Once manufacture has commenced, neither Party may unwind the Case.

(e) Before the no-cancellation event. Before manufacture commences, either Party may decline to proceed to manufacture, subject to the Customer's accrued obligation to pay for design work already performed under clauses 5.5 and 6.6.

5. Design, Approval and revisions

5.1 Two design stages; Approval of the Treatment Plan authorises manufacture. Design proceeds in two stages. Stage 1 — the Treatment Plan: the Lab prepares preliminary planning (implant positions, nerve and anatomical marking, crown positions and the aligned and merged STL and DICOM data) and presents it to the treating Practitioner for review and approval. Stage 2 — the Guide Design: the Lab designs the physical Surgical Guide itself (sleeves, anchor pins, guide body and support structures) to implement the Approved Plan. It is the Practitioner's Approval of the Treatment Plan (stage 1) that authorises the Lab to proceed — the Guide Design and manufacture are then carried out to implement the Approved Plan. Approval locks the approved version of the Treatment Plan. How the plan is presented, the alternative path where the Practitioner supplies their own final plan, and the status of the Guide Design are dealt with in clause 5.7.

5.2 Who may approve. Approval may be given only by the treating Practitioner responsible for the Case. Practice staff and other Authorised Users may prepare, submit and manage a Case, but Approval may not be delegated to a coordinator, administrator or other non-Practitioner, and there is no override or "break-glass" approval.

5.3 Effect of Approval. By giving Approval the Practitioner confirms that the Practitioner has reviewed the Treatment Plan and is clinically satisfied with it, including the planned implant positions, angulations and depths, the nerve and anatomical marking, the crown positions, and the alignment of the plan to the Practitioner's own scan data. Approval is recorded as an append-only entry that includes the approving user, the version of the Treatment Plan approved, the time of Approval, and may include the hash of the reviewed files, screenshots and/or project file and the network address from which Approval was given where the Platform captures them. That record is evidence of the Approval of the plan; it is not represented to be the complete or definitive medico-legal record of the Case.

5.4 Revisions. Before Approval the Practitioner may request revisions to the Treatment Plan. The Case returns to planning and a revised Treatment Plan is published for review. Included in each Case are either two (2) rounds of email plan amendments or one (1) virtual planning session. A further plan amendment beyond those included is charged at $45 (AUD, ex GST) per amendment under the Price List, which the Lab will notify before proceeding. Revisions are counted against the Treatment Plan; the Lab's later work on the Guide Design (stage 2) is not a revision round and is not subject to Practitioner sign-off (clause 5.7(c)).

5.5 Planning and Revision Fee where Approval is delayed. If a published Treatment Plan remains unapproved, the following applies:

(a) the Lab may send reminders;

(b) if the Treatment Plan remains unapproved 21 days after it was published, the Case may be placed on hold and an invoice for the completed planning work (the Planning and Revision Fee, calculated under clause 6.1) may be issued;

(c) if the Case is ultimately approved, that fee is credited against the final invoice for the Case; except that the fee is not credited if any of the following occurs: (i) a new DICOM or replacement scan is provided; (ii) the Treatment Plan is changed such that the Case must be restarted from scratch; or (iii) Approval occurs more than ninety (90) days after the Treatment Plan was first sent for review;

(d) a Case that remains unapproved may be auto-cancelled 90 days after the Treatment Plan was first sent for review.

5.6 Late Approval affects delivery. The turnaround clock does not run while a Case awaits Approval of the Treatment Plan. Late Approval moves any estimated delivery date out accordingly and may affect delivery reliability.

5.7 How the Treatment Plan is presented; Practitioner-supplied plan; status of the Guide Design.

(a) Presentation of the plan. The Lab presents the Treatment Plan for review and Approval as screenshots and/or the software project file (as applicable to the case and the Practitioner's tools). Approval given on that presentation is the Approval that authorises manufacture under clause 5.1.

(b) Practitioner-supplied final plan (alternative path). A Practitioner may instead supply their own Treatment Plan, declared as final. In that case the Lab's role is limited to re-aligning and merging the STL and DICOM data, and the Lab does not reposition the implants; the supplied plan is treated as the Approved Plan. Exception — technical problem with implant positions: if the Lab identifies a technical problem with the implant positions, it will notify the Practitioner and may decline to proceed to manufacture until the problem is resolved and the amended plan is re-approved by the Practitioner; the Lab may, with the Practitioner's agreement, make the necessary changes and present the amended plan for re-approval. Where the Practitioner supplied the plan, responsibility for the implant positions rests entirely with the Practitioner (including where the Lab has not identified a problem), while the Lab remains responsible for accurate STL/DICOM alignment and for the Guide implementing the plan (clause 8.1A).

(c) The Guide Design is the Lab's work product — no approval obligation. The design of the physical guide itself (the Guide Design — sleeves, anchor pins, guide body and support structures, being what goes to print) is the Lab's work product and is not subject to the Practitioner's approval; the Lab is under no obligation to obtain the Practitioner's sign-off on it (as a lab is not obliged to have a crown's final design approved by the prescribing dentist). However, if the Practitioner requests confirmation of the Guide Design before printing, the Lab will provide screenshots for confirmation; where such confirmation is requested and given, it forms part of the Case record. This does not make the Guide Design a matter for Approval and does not add a revision round under clause 5.4.

6. Fees, GST and payment

6.1 Pricing — Price List, preliminary estimate and two-stage price lock.

(a) Price List governs. Fees for a Case are calculated according to the Lab's versioned Price List. Surgical Guide prices are set out in the Price List (currently ranging, by way of illustration only and subject to the Price List in force, from $350 to $1,060 per arch (ex GST) depending on guide type); the Price List, not this clause, states the current prices.

(b) Planning and Revision Fee. The Planning and Revision Fee (the design/planning component referred to in clause 5.5) is $105 per arch (AUD, ex GST), which includes the first implant site, plus $30 (ex GST) for each additional implant site. (For example, a single-arch Case with three sites carries a PRF of $105 + $30 × 2 = $165 ex GST.) The PRF is the planning fee only and is not the price of a Surgical Guide.

(c) Preliminary estimate at submission. The price shown when a Case is submitted is a preliminary estimate based on the configuration the Customer declares in the Case. The final Fees reflect the actual Approved Plan and the actual guide(s) manufactured, and may differ from the estimate where the approved configuration differs from that declared.

(d) Two-stage price lock. The Price List version applied to a Case is locked in two stages:

    (i) the planning and Planning and Revision Fees are charged at the Price List in force on the date the Case is submitted; and

    (ii) the Surgical Guide price is charged at the Price List in force on the date of Approval (approval of the Treatment Plan).

A later change to the Price List does not otherwise apply to a Case except as fixed by (i) and (ii) or unless the Customer expressly agrees to it for that Case.

    (iii) Costless exit on a material price increase. Before Approval can be given for a Case, the Platform displays to the Practitioner the itemised final price for the Case and the version of the Price List applied to it. If the Surgical Guide price under the Price List in force at Approval is materially higher than the preliminary estimate given at submission for the same declared configuration — that is, it exceeds that estimate by the greater of A$50 or 10% — the Customer may, at any time before giving Approval, withdraw the Case without charge; in that event the Planning and Revision Fee under clause 5.5 is not payable. This exit does not apply where the difference results from a change in the Case's actual configuration (clause 6.1(c)). For the avoidance of doubt, this clause 6.1(d)(iii) prevails over clauses 5.5 and 6.6 to the extent of any inconsistency.

(e) All amounts under this Agreement are exclusive of GST.

6.2 GST. The Lab is registered for GST. GST at the applicable rate (currently 10%) is added to taxable supplies and shown on the tax invoice.

6.3 Payment terms and credit.

(a) Default — prepayment. The default payment term under this Agreement is prepayment. Acceptance of this Agreement does not entitle the Customer to any credit or deferred-payment terms, and no credit is guaranteed.

(b) Net / EOM terms require a Credit Application. A Customer seeking Net or EOM terms (for example Net 14, Net 30, or Net 30 EOM) must apply through a separate Credit Application in which the Customer states the terms it requests. The Lab reviews the application and may grant the requested terms, decline them, or counter-offer lesser terms (for example, granting Net 30 where Net 30 EOM was requested). Granted credit terms take effect only under a separate credit agreement, signed by a director of the Customer by electronic signature and supported by a personal guarantee, and are subject to any credit limit the Lab sets. The Credit Application and credit agreement are separate documents; this Agreement references the mechanism but does not itself grant credit.

(c) Where terms are shown. The Customer's applicable payment term is shown in the Platform. Payment terms and any credit limit are set by the Lab; a request to change payment terms is routed to the Lab through the Credit Application process and is not self-service.

6.4 How the payment gate works. Prepayment gates the stage-2 Guide Design (the production-ready design) and production — not stage-1 planning.

(a) Prepayment Accounts. Stage-1 planning (preparation of the Treatment Plan) proceeds so that the Practitioner has a plan to review; the payment gate sits at Approval of the Treatment Plan, before the Lab commits to the stage-2 Guide Design and to manufacture. The Case does not proceed into the Guide Design or production until cleared payment is received. Stage-1 planning is not blocked by payment. The invoice is raised: for Design & Print and Design-Only packages, at Approval (when the Treatment Plan is approved); for Printing-Only work (where the Customer supplies its own design file and there is no plan/approval phase), at submission.

(b) Account (Net/EOM) terms. Manufacture is not withheld pending payment. The invoice is issued after Approval (or, for Printing-Only work, after the Lab verifies the files), and payment is due per the Customer's terms; the awaiting_payment status may sit between shipped and completed without blocking the Case.

(c) A separate hold where files or instructions are missing (the pending_files / pending_instructions statuses) operates independently of the payment gate.

6.5 Overdue accounts — the overdue ladder. If an invoice is not paid by its due date:

(a) the Lab sends a reminder at 5 days overdue;

(b) at 30 days overdue, the Customer's Account may be blocked from placing new orders until the overdue amount is paid. A blocked Account is not deleted or closed: the Customer keeps access to the Platform, can view its Cases and records, and can pay outstanding invoices; only the placing of new Cases is stopped;

(c) chronic late payment (repeated or persistent overdue accounts) may result in the Account being converted to prepayment terms for a period of 3, 6 or 12 months at the Lab's discretion.

The Lab may charge interest on overdue amounts at 1.5% per month (a discretionary right, mirroring the Lab's existing terms; it is not the Lab's practice to charge it, but the right is reserved). "Blocked" is distinct from "suspended": see clause 14.

6.6 Planning work is chargeable. Where the Lab has published a Treatment Plan for a Case, that planning work is chargeable as the Planning and Revision Fee under clauses 5.5 and 6.1, even if the Customer does not proceed to Approval, subject to the credit arrangements in clause 5.5(c). The fee is triggered in two situations only: (i) passively, where a published Treatment Plan remains unapproved for 21 days under clause 5.5(b); or (ii) actively, where the Customer notifies the Lab before the 21-day mark that it will not proceed (for example because the patient has withdrawn), in which case the Lab finalises the invoice for the planning work performed at the point of that notification. An early, Customer-initiated withdrawal after planning work has been performed attracts the same Planning and Revision Fee as passive non-response, calculated to the point of withdrawal. This clause does not permit the Lab to charge from day 1 for a Case that is still active and progressing toward Approval before any Treatment Plan has been published.

6.7 Payment method. Payments are processed through the Lab's third-party payment and accounting providers. The Lab does not store full credit card details on its systems.

6.8 No published discounts implied. Nothing in this Agreement entitles the Customer to any discount. Any discount the Lab applies is at its sole discretion.

6.9 Priority / expedited turnaround. Where the Customer elects a priority or expedited (rush) turnaround for a Case, a priority surcharge as set out in the Price List applies, and an accelerated-approval window applies to that Case. If the Practitioner does not give Approval of the Treatment Plan within the accelerated window (currently: approve within 3 business hours, as shown in the Platform), the Case reverts to standard turnaround and any priority or rush surcharge already paid is non-refundable. Delivery and turnaround remain estimates only (clause 9).

7. Customer obligations — files, instructions, consent and infection control

7.1 Supply of files, prescription and instructions. The Customer must supply complete, accurate and usable Case Files and a clear written prescription and instructions for each Case before design begins. The prescription and instructions must identify, at a minimum: (a) the intended purpose and clinical use of the Surgical Guide; (b) the named patient (or a patient identifier sufficient for traceability); (c) the required design characteristics, including the relevant tooth or implant sites and the implant system or componentry to be accommodated; and (d) any clinical constraints or special requirements relevant to the design. This information supports the applicable personalised-device pathway and the Lab's traceability obligations. The turnaround clock starts the Business Day after all required files and the prescription have been received and verified.

7.2 Patient consent and authority. The Customer warrants that, for each Case, the treating Practitioner has the necessary patient consent and legal authority to share the Practitioner Data (including patient health information) with the Lab for the purpose of manufacturing the ordered Surgical Guide.

7.3 Accuracy of clinical data. The Customer is responsible for the accuracy of the scan data and clinical information supplied. The Lab designs and manufactures the Guide to implement the Approved Plan derived from (or, where the Practitioner supplies the plan, built on) that data; the Lab does not independently verify the clinical correctness of the underlying scans.

7.4 Registration. The Customer warrants that it is, or engages, a registered dental practitioner (or is a dental practice or dental laboratory employing or engaging registered practitioners) entitled to prescribe and use surgical guides, and that each Practitioner giving Approval is so registered.

7.5 Delay from incomplete information. The Lab is not responsible for delay caused by incomplete, inaccurate or late Case Files or instructions, or by delay in giving Approval.

7.6 Infection control — items sent to the Lab. Where the Customer sends any physical item to the Lab (for example an impression, a physical model, an appliance or other object), the Customer must decontaminate it before dispatch in accordance with the Dental Board of Australia's Guidelines on Infection Control and applicable infection-control standards, and warrants that each such item supplied to the Lab has been so decontaminated and is safe to handle. The Lab may decline to handle, or may return or dispose of, an item that is not, or is not evidenced to be, decontaminated, and the Customer is responsible for any resulting delay.

8. Clinical responsibility and use of the Guide

8.1 The Practitioner owns clinical decisions. The treating Practitioner is solely responsible for all clinical decisions relating to a Case, including implant selection, implant positioning and angulation, treatment planning, the decision to approve the Treatment Plan, the suitability of the Surgical Guide for the patient, and all surgical use of the Guide. The Customer procures that its Practitioners meet this clause.

8.1A Allocation of responsibility for the plan and the Guide. The Approved Plan (the implant positions, angulations, depths and the clinical treatment planning) is the Practitioner's clinical work: the Practitioner is responsible for it, whether the Practitioner approves a plan the Lab prepared in stage 1 or supplies their own final plan under clause 5.7(b). Where the Practitioner supplies the plan, responsibility for the implant positions rests entirely with the Practitioner, subject to the technical-problem mechanism in clause 5.7(b). In every case the Lab remains responsible for accurately aligning and merging the STL and DICOM data and for the Guide Design correctly implementing the Approved Plan and for manufacturing the Guide to that Guide Design.

8.2 The Lab does not practise dentistry. The Lab designs and manufactures the Guide to implement the Approved Plan. Nothing the Lab does, and no communication from the Lab, constitutes clinical or dental advice, a second opinion, or the practice of dentistry, and no practitioner–patient relationship arises between the Lab and any patient.

8.3 Verification against the Practitioner's data. The fitness of a Surgical Guide is verified against the Practitioner's own scan data:

(a) Where a Case includes a printed model (for example a tooth-supported or bone-supported guide with a model), that model is the fit-verification artefact against the Practitioner's scan data, and fit evidence is assessed against it.

(b) Where a Case does not include a printed model (for example a tissue-supported guide, for which no printed model is produced), fit is instead evidenced against the design record — the Approved Plan, the Guide Design implementing it, and the Practitioner's supplied scan data on which they were built.

In either case, if the supplied scan data was inaccurate, a resulting misfit is a matter of the clinical data supplied and not a manufacturing defect (see clause 10.4).

8.4 Use of the Guide. The Surgical Guide must be used only by a registered practitioner, only for the named patient, and in accordance with sound clinical judgment. The Practitioner is responsible for confirming the fit and suitability of the Guide before clinical use.

8.5 Non-sterile supply and sterilisation. Surgical Guides are supplied non-sterile. Before any clinical use, the Practitioner is responsible for sterilising the Guide by a method appropriate to the material and to the clinic's infection-control obligations. The Guides are manufactured from a steam-autoclavable material (NextDent SG, per its manufacturer's instructions for use); the Practitioner must sterilise in accordance with those instructions and the clinic's own validated processes. The Lab does not represent that a Guide is supplied sterile or ready for use without sterilisation.

9. Turnaround and delivery

9.1 Turnaround estimates are not binding. Any turnaround time or estimated delivery date is an estimate only and is not a contractual commitment. The turnaround clock starts the Business Day after complete files and prescription are received and verified, and excludes time while a Case awaits Approval.

9.2 Delivery. The Lab dispatches Surgical Guides by third-party courier (currently Team Global Express) for delivery within Australia to business addresses only. Delivery is included in the price of Surgical Guide packages; for a standalone item not part of a guide package, a delivery charge of $30 (ex GST) applies as set out in the Price List. Delivery times depend on the courier and the destination and are outside the Lab's control; the Lab does not represent or guarantee any particular delivery time, including for metropolitan destinations. There is no weekend delivery.

9.3 Third-party delay. The Lab is not liable for delay caused by a courier or by any other matter beyond the Lab's reasonable control.

9.4 Risk and title.

(a) Risk in a Surgical Guide passes to the Customer on delivery to the Customer's nominated business address (or on first attempted delivery there). Until delivery, the Lab bears the risk of loss of or damage to the Guide in transit, and clause 9.6 applies.

(b) Title in a Surgical Guide passes to the Customer only when the Lab has received payment in full of all amounts owing for that Case. Until title passes, the Lab retains title as security for payment.

(c) PPSA / purchase-money security interest. The Customer acknowledges that the retention of title in clause 9.4(b) grants the Lab a security interest, and a purchase-money security interest (PMSI), in each Surgical Guide (and its proceeds) to secure payment, as those terms are defined in the Personal Property Securities Act 2009 (Cth) (PPSA). The Customer must do anything the Lab reasonably requires to enable the Lab to register, perfect and maintain that security interest on the Personal Property Securities Register (PPSR). To the extent permitted by section 115 of the PPSA, the Parties contract out of, and the Customer waives its rights to receive, the notices and statements under sections 95, 118, 121(4), 130, 132(3)(d), 132(4), 135, 142 and 143 of the PPSA. This does not exclude any right or remedy that the PPSA does not permit to be excluded (including the duty to act honestly and in a commercially reasonable manner under section 111, and any right that cannot be excluded where the collateral is used predominantly for personal, domestic or household purposes), and the Customer retains all such non-waivable rights. The Lab may register its security interest over all present and after-acquired Surgical Guides supplied to the Customer, using the grantor identifier prescribed by the Personal Property Securities Regulations 2010 (Cth) for the Customer's actual legal character and capacity (including the trust-specific identification rules where the Customer contracts as trustee). The Customer must, on request, supply the details the Lab reasonably requires to register and perfect its security interest using the correct grantor identifier. The Lab aims to effect and maintain that registration before each Case is supplied so as to preserve its purchase-money security interest priority.

9.5 Optional cover. The Customer may arrange its own cover for a delivered Guide if it wishes.

9.6 Loss or damage in transit. Because risk passes on delivery (clause 9.4(a)), the following process applies to loss or damage in transit, without limiting the Customer's rights under clause 12 or the ACL:

(a) the Customer should inspect a Surgical Guide on delivery and notify the Lab of visible transit damage or of non-delivery as soon as practicable, and in any event within 3 days of the delivery date (or of the expected delivery date, for non-delivery);

(b) the Customer will provide the information reasonably needed to support a courier claim (including packaging, photographs and delivery records) and will cooperate with the Lab in pursuing it;

(c) as risk in transit is the Lab's until delivery, the Lab will remake and reship a Surgical Guide lost or damaged in transit and notified under (a), at no charge to the Customer, and will pursue any courier claim; and

(d) this clause does not apply to damage occurring after delivery, which is dealt with in clause 10.3.

10. Remakes, adjustments and warranty against defects

10.1 Fitness at dispatch and delivery. The Lab warrants that a Surgical Guide conforms to its Guide Design (which the Lab prepared to implement the Approved Plan) at the time of dispatch and, subject only to transit damage dealt with under clause 9.6, on delivery.

10.2 Manufacturing defect. A manufacturing defect is a failure of the Surgical Guide to conform to its Guide Design implementing the Approved Plan that is attributable to the Lab's design or manufacture — as distinct from transit loss or damage (dealt with in clause 9.6) and from a misfit caused by inaccurate scan data (dealt with in clause 10.4). A guide that does not conform to the Approved Plan because the Guide Design failed to implement it correctly, or because manufacture departed from the Guide Design, is a manufacturing defect. If a Surgical Guide has a manufacturing defect, the Lab will, at its election, remake or repair the Guide at no charge, or refund the amount paid for it. To claim, the Customer must notify the Lab within 14 days of delivery for a defect apparent on delivery and, if requested, return the affected Guide. A defect that was not reasonably apparent on delivery (a latent defect) may be notified within a reasonable time after it becomes apparent; conformity is assessed against the Guide Design implementing the Approved Plan as at the time of dispatch.

10.3 Remake where the Customer is at fault. Where a Guide is damaged, lost or made unusable after delivery through no fault of the Lab, or where a remake is required because of a change requested by the Customer or its Practitioner, a remake is charged at 50% of the Guide price plus reshipping (ex GST), consistent with the Lab's remake policy.

10.4 Scan-based or plan-based misfit. Where a Guide conforms to its Guide Design implementing the Approved Plan but does not fit clinically because the underlying scan data was inaccurate, or because of the implant positions in the Approved Plan (including a plan the Practitioner supplied under clause 5.7(b)), this is not a manufacturing defect and a free remake does not apply. Fit is assessed under clause 8.3 — against the printed model where a Case includes one, or otherwise against the design record (the Approved Plan, the Guide Design and supplied scan data). Where a misfit is traceable to the Customer's scan data or supplied plan, the Lab may, at its discretion, offer a goodwill discount on a remake; it is not obliged to remake free of charge.

10.5 Consumable and third-party components. Where a Surgical Guide is remade for a reason attributable to the Customer or otherwise outside the Lab's warranty (for example under clause 10.3 or 10.4), any implant componentry, sleeves, pins or third-party parts supplied with or for the Guide are re-charged on the remake. Where a remake is required because of a Lab manufacturing defect (clause 10.2), or where such a component was supplied defective by the Lab, the component is not re-charged, and nothing in this clause limits the Customer's remedies under clause 12 or the ACL for a defective Lab-supplied component.

10.6 This clause is subject to the ACL. Nothing in this clause 10 limits the Customer's rights under clause 12 or the ACL.

11. Intellectual property, confidentiality and privacy

11.1 Practitioner Data. As between the Parties, the Customer (or its patient, as the case may be) owns the Practitioner Data, including patient scan and DICOM data. The Customer grants the Lab a licence to use the Practitioner Data to the extent necessary to fulfil the Case and, in each case only to the extent necessary and subject to the privacy safeguards in clause 11.4 and the retention limits in clause 11.7: for quality assurance; to investigate and handle complaints and disputes; for device traceability; for recalls, safety alerts and other corrective action; for adverse-event reporting; for the safety, incident and recall activity described in clause 3.5; and to meet the Lab's medical-device record-keeping and other legal obligations.

11.2 Design Files (the Guide Design). As between the Parties, the Lab owns the Design Files it creates (which embody the Guide Design — guide geometry, sleeve and support-structure design and manufacturing set-up), which are the Lab's stage-2 work product and are not subject to the Practitioner's approval (clause 5.7(c)). The Customer receives the physical Surgical Guide, its Guide Design implementing the Approved Plan; the Customer does not, by placing a Case or by approving the Treatment Plan, acquire ownership of the underlying Design Files. The Lab will release a Case's Design File to the Customer on request, except for stackable, bone-supported and zygomatic guide designs, which are the Lab's intellectual property and are not released. Any released Design File is provided for the Customer's use in connection with the patient's treatment and does not transfer ownership of the Lab's underlying design IP. The Practitioner's ownership of the Practitioner Data (clause 11.1) and any Approved Plan the Practitioner supplied is unaffected; approval of the Treatment Plan does not transfer the Guide Design to the Customer.

11.3 Confidentiality.

(a) Confidential Information means information disclosed by or on behalf of one Party (the discloser) to the other (the recipient) that is marked confidential or that a reasonable person would understand to be confidential, including the discloser's business, pricing, technical and clinical information and the Design Files. It does not include information that: (i) is or becomes public other than through the recipient's breach; (ii) the recipient already lawfully held free of any duty of confidence; (iii) the recipient lawfully receives from a third party free to disclose it; or (iv) the recipient independently develops without using the discloser's Confidential Information.

(b) Obligation. The recipient must keep the Confidential Information confidential, use it only for the purposes of this Agreement, and disclose it only to its personnel, subcontractors and professional advisers who need it and who are bound by equivalent obligations, and the recipient remains responsible for their compliance.

(c) Compelled disclosure. The recipient may disclose Confidential Information to the extent required by law or by a regulator or court and, where lawful and practicable, will first notify the discloser to allow it to seek protective measures.

(d) Duration, return and retention. These obligations continue during this Agreement and for 5 years after it ends (and indefinitely for information that is personal or health information, which is also governed by clause 11.4 and the Privacy Policy). On request after termination, the recipient will return or destroy the discloser's Confidential Information, except to the extent it must be retained to meet medical-device, legal or record-keeping obligations, in which case these confidentiality obligations continue to apply to the retained copy.

(e) This clause does not limit clause 11.1 (Practitioner Data), clause 11.2 (Design Files) or clause 11.4 (privacy).

11.4 Privacy — the Lab as service provider. Where the Lab receives Practitioner Data containing patient health information, it collects and holds that information as a service provider processing it on behalf of the Customer and its Practitioner for the purpose of manufacturing the ordered Surgical Guide. The Lab is bound in full by the Privacy Act 1988 (Cth) and the Australian Privacy Principles in respect of health information (the small-business exemption does not apply to an organisation that holds health information in providing a health service). The Lab:

(a) does not use or disclose that information for any independent or secondary purpose without consent, except: as required by law; as permitted by clause 11.7; or for the purposes permitted by clause 11.1 (quality assurance; complaints and disputes; device traceability; recalls, safety alerts and other corrective action; adverse-event reporting; the clause 3.5 safety, incident and recall activity; and medical-device record-keeping and other legal obligations), in each case only to the extent necessary and subject to the privacy safeguards in this clause 11.4 and the retention limits in clause 11.7;

(b) takes steps reasonable in the circumstances to protect it against misuse, loss and unauthorised access or disclosure (Australian Privacy Principle 11);

(c) does not disclose it overseas except with consent or where an exception under the Australian Privacy Principles applies;

(d) handles it in accordance with the Privacy Policy; and

(e) provides a complaints and contact channel at support@prodigident.com.au.

11.5 Named service providers. The Lab uses third-party service providers disclosed in the Privacy Policy (currently including its accounting, payment, courier and file-storage providers). The Lab will not introduce a new category of provider that receives patient health information without first updating the Privacy Policy.

11.6 Data breach and incident cooperation. The Lab complies with the Notifiable Data Breaches scheme. Where the Lab has reasonable grounds to suspect that an eligible data breach may have occurred, it carries out a reasonable and expeditious assessment of whether there are reasonable grounds to believe it is an eligible data breach, and takes all reasonable steps to complete that assessment within 30 days (Privacy Act 1988 (Cth), s 26WH). Where the Lab has reasonable grounds to believe there has been an eligible data breach, it notifies the Office of the Australian Information Commissioner and affected individuals as soon as practicable, consistently with that scheme and the Privacy Policy. In addition, if either Party becomes aware of a security incident or suspected data breach affecting Practitioner Data, the Parties will each notify the other promptly, share the information reasonably needed to assess, contain and remediate it, and cooperate in good faith on containment, notification and remediation, consistent with the Privacy Policy and each Party's obligations under the Notifiable Data Breaches scheme and other applicable law; each Party bears its own costs except to the extent the incident is attributable to that Party's act, omission or breach. This clause does not require a Party to act inconsistently with its own legal or professional reporting obligations.

11.7 Data retention. The Lab retains records for as long as reasonably necessary for the purposes for which they were collected and to meet legal, medical-device and record-keeping obligations. In particular, and by way of the Lab's retention practice: tax invoices and financial records are retained for at least 7 years; Design Files and device-conformity records for at least 10 years; and CBCT/DICOM scan data is moved to cold archive after 2 years and thereafter retained or securely deleted or de-identified in accordance with the Privacy Policy and applicable law.

12. Consumer guarantees, liability and indemnity

12.1 Consumer guarantees not excluded. Nothing in this Agreement excludes, restricts or modifies any Consumer Guarantee or other right or remedy under the ACL that cannot lawfully be excluded, restricted or modified.

12.2 Limitation of liability for goods. To the extent permitted by section 64A of the ACL, the Lab's liability for a failure to comply with a Consumer Guarantee in relation to goods (other than a guarantee under sections 51, 52 or 53, and other than for a major failure) is limited, at the Lab's election, to:

(a) replacing the Surgical Guide or supplying an equivalent Guide;

(b) repairing the Guide; or

12.3 Limitation of liability for services. To the extent permitted by section 64A of the ACL, the Lab's liability for a failure to comply with a Consumer Guarantee in relation to services (other than for a major failure) is limited, at the Lab's election, to supplying the services again or paying the cost of having the services supplied again.

12.4 Reasonableness. The Customer acknowledges that, having regard to the business nature of the supply, the limitations in clauses 12.2 and 12.3 are fair and reasonable. This acknowledgment is not the compliance mechanism for the Unfair Contract Terms regime; the limitations are drafted to sit within section 64A of the ACL.

12.5 Exclusion of other liability. Subject to clause 12.1 and to the extent permitted by law, the Lab is not liable to the Customer for:

(a) any clinical outcome to the extent caused by a clinical decision, clinical use, patient factors, or data supplied by the Customer — including any outcome arising from implant selection, positioning, treatment planning, the Approved Plan (including a plan the Practitioner supplied), the decision to approve the Treatment Plan, or surgical use of a Guide — provided that this paragraph does not exclude liability for loss caused by the Lab's breach of this Agreement, the Lab's negligence, a manufacturing defect, a failure of the Guide Design to implement the Approved Plan, or the Lab's breach of its STL/DICOM-alignment or technical-problem duties (clauses 8.1A, 5.7(b));

(b) any loss arising from inaccurate or incomplete Case Files or instructions supplied by the Customer;

(d) delay caused by a third-party courier or a matter beyond the Lab's reasonable control.

12.6 Cap on liability. Subject to clause 12.1 and to the extent permitted by law, the Lab's total aggregate liability to the Customer arising out of or in connection with a Case is limited to the Fees paid by the Customer for that Case. This cap does not apply to, and does not limit, liability that cannot lawfully be capped, including: (a) liability under a Consumer Guarantee or other non-excludable ACL right; (b) liability for death or personal injury caused by the Lab's negligence; (c) liability for the Lab's breach of its privacy or confidentiality obligations (clause 11); or (d) liability for the Lab's fraud, dishonesty or wilful default.

12.7 Customer indemnity. The Customer indemnifies the Lab against loss, damage, liability, cost and expense (including reasonable defence costs) the Lab suffers or incurs from a third-party claim to the extent directly caused by:

(a) the Customer's breach of clause 7 (including any failure to obtain patient consent or legal authority to share the Practitioner Data, or any breach of the infection-control warranty in clause 7.6);

(b) a clinical decision, diagnosis, treatment or surgical use by the Customer's Practitioner; or

(c) a claim by a patient or third party arising from the Customer's or its Practitioner's negligent, unlawful or wrongful use of a Surgical Guide, or from breach of an express clinical obligation of the Customer or its Practitioner.

This indemnity is reduced proportionately to the extent the loss is caused or contributed to by the Lab's own breach of this Agreement, negligence, act, omission or wilful default, and does not extend to any fine or civil penalty that cannot lawfully be the subject of an indemnity. It is drafted to be no broader than reasonably necessary to protect the Lab's legitimate interest in the Customer's consent/authority compliance and the Practitioner's own clinical conduct.

13. Trustee capacity

13.1 Capacity. The Lab enters into this Agreement solely in its capacity as trustee of the Trust and in no other capacity.

13.2 Limitation of recourse. The Lab's liability under or in connection with this Agreement is limited to, and may be enforced against the Lab only to the extent of, the Lab's right of indemnity out of, and the assets of, the Trust from time to time available to satisfy that liability.

13.3 Carve-out. Clause 13.2 does not apply to, and does not limit the Lab's liability for, any liability of the Lab to the extent it arises from the Lab's own fraud, dishonesty or wilful default (including a failure or omission that reduces or extinguishes the Lab's right of indemnity out of the Trust assets).

13.4 Trustee Customers — representations. Where the Customer enters into this Agreement as trustee of a trust, the Customer represents and warrants to the Lab that: (a) it is validly appointed as trustee of that trust and is not in breach of the trust deed; (b) it has power under the trust deed to enter into and perform this Agreement, and entry into this Agreement is for a proper purpose of the trust; (c) it has an unrestricted right of indemnity out of the trust assets in respect of its obligations under this Agreement, and that right has not been lost, limited or impaired; and (d) it enters into this Agreement both personally and in its capacity as trustee and is liable in both capacities. For the avoidance of doubt, clause 13.2 limits the recourse of the Customer against the Lab only; nothing in this clause 13 limits the Lab's recourse against a trustee Customer, its trust assets, or the Customer personally.

14. Account status — blocked and suspended

14.1 Blocked (overdue). A blocked Account (clause 6.5) is stopped from placing new Cases but is otherwise live: the Customer keeps access to the Platform, can view its Cases and records, and can pay outstanding invoices. Blocking is lifted once the overdue amount is paid. Blocking is not suspension or closure.

14.2 Suspension and closure. Because the Lab does not suspend or close an Account while a balance is owing, suspension or closure of an Account is possible only at a zero balance. The Lab may suspend or close an Account (for example for a legal or regulatory reason, serious or repeated breach, or at the Customer's request) only where no amount is outstanding; suspension blocks Platform access and closure ends the account relationship, in each case without deleting records the Lab must retain.

14.3 Effect on current Cases. On blocking, suspension or closure, the Lab may complete, hold or decline to continue Cases in progress, acting reasonably and having regard to any patient-safety considerations and to amounts owing.

15. Termination

15.1 Termination for convenience. Either Party may terminate this Agreement on 30 days' written notice. Termination does not affect Cases for which manufacture has already commenced (the no-cancellation event in clause 4.3(d)), which continue to completion under this Agreement, or accrued rights and obligations (including payment obligations).

15.2 Termination for breach or insolvency. The following termination grounds are mutual and proportionate:

(a) Material breach. Either Party may terminate by written notice if the other Party commits a material breach that is not remedied within 30 days of written notice specifying the breach.

(b) Insolvency — always-enforceable grounds. Either Party may terminate immediately by written notice on the other Party's liquidation or winding-up, and the Lab may exercise its non-payment and account-blocking rights (clauses 6.5, 14) and terminate for a payment default that remains uncured after the 30-day material-breach process; these grounds arise from breach or from winding-up and are not stayed by the ipso facto regime.

(c) Administration, receivership or scheme — suspended-not-void. A right to terminate solely because the other Party enters voluntary administration or receivership, or proposes a scheme of arrangement, or because of its financial position while in one of those states, is suspended for so long as a statutory stay under the ipso facto provisions of the Corporations Act 2001 (Cth) operates, and revives when the stay ends. During any such stay the Party may still rely on the always-enforceable grounds in (b).

15.3 Survival. Clauses that by their nature should survive termination (including clauses 6, 8, 11, 12, 13 and 16) survive.

16. General

16.1 Governing law and jurisdiction. This Agreement is governed by the laws of Queensland, Australia. The Parties submit to the non-exclusive jurisdiction of the courts of Queensland and courts hearing appeals from them.

16.2 Dispute resolution. Before starting court proceedings (other than for urgent relief), a Party must notify the other of the dispute and the Parties must attempt in good faith to resolve it. The Customer may raise a concern at support@prodigident.com.au, and the Lab aims to respond within 30 days.

16.3 Notices. Notices to the Lab may be sent to support@prodigident.com.au. Notices to the Customer may be sent to the email address on the Account or through the Platform. A notice sent by email or through the Platform is deemed received on the day it is sent if that is a Business Day and it is sent before 5:00pm Australia/Brisbane time, and otherwise on the next Business Day — unless the sender receives an automated delivery-failure or bounce notification, in which case the notice is not treated as received and must be resent by another means. Each Party must keep its contact details on the Account current. This clause does not apply to the service of court documents.

16.4 Variation. Except for new versions issued and accepted under clause 2.3, this Agreement may be varied only in writing agreed by both Parties. Where the Lab varies this Agreement by issuing a new version, it does so only under the re-acceptance mechanism in clause 2.3 — a material change requires at least 30 days' written notice, presentation for acceptance with a hard block on new Cases until accepted, and a penalty-free right for the Customer to close its Account rather than accept; a minor change may be notified by banner. A variation does not apply to a Case already submitted (clause 2.3A).

16.5 Assignment. Neither Party may assign or novate this Agreement without the other Party's prior written consent (not to be unreasonably withheld or delayed), except that the Lab may assign or novate it to an affiliate, or in connection with a sale of the whole or substantially the whole of its business, on notice to the Customer. This mutual formulation, with a limited affiliate/sale-of-business carve-out, is intended to be reasonably necessary to protect the Lab's legitimate interest in business continuity and not to be an unfair term.

16.6 Entire agreement. This Agreement, together with the Price List, the Privacy Policy, the Portal Terms of Use and any surviving practice-level agreement, is the entire agreement between the Parties about the ordering, supply and manufacture of Surgical Guides and supersedes prior representations, including the practice-level MSA version "2026-05" (clause 2.6) and any placeholder text previously shown in the Platform. Any inconsistency between those documents is resolved under the order of precedence in clause 2.5.

16.7 Severance. If a provision is void or unenforceable, it is severed to the extent necessary and the rest of the Agreement continues.

16.8 Waiver. A failure to exercise a right is not a waiver of it.

16.9 No consumer misrepresentation. Nothing in this Agreement is intended to mislead the Customer about its statutory rights.

16.10 Subcontracting. The Lab may subcontract the performance of any part of its obligations (including the stage-2 Guide Design of a Case, which may be performed through a cloud design service such as Implastation), and remains responsible for the subcontracted performance. A subcontractor that receives Confidential Information or patient health information is bound by obligations equivalent to clauses 11.3 and 11.4.

16.11 Third-party software dependency. The Lab's design and manufacturing workflow depends on third-party software and cloud services (including the Implastation planning/design platform). The Customer acknowledges that the availability and performance of those third-party services are outside the Lab's control, and that a delay or failure attributable to such a service is a matter beyond the Lab's reasonable control for the purposes of clauses 9.3 and 12.5(d) — but the Lab is entitled to that relief only where the failure is not caused by the Lab's own fault, the Lab selected the provider with reasonable care, and the Lab gives the Customer prompt notice of the failure and takes reasonable steps to mitigate it and to maintain continuity of the affected Case. If a material failure of such a service persists beyond 10 Business Days, either Party may cancel an affected Case without charge, and the Lab refunds any amounts the Customer has prepaid for work not performed on that Case. This clause does not affect accrued payment or remedy rights.