Terms of service

IMPORTANT NOTICE

These Terms of Service form a legally binding agreement between you and Sapyen concerning your purchase of, access to and use of Sapyen products and services.

Please read them carefully.

These Terms include provisions relating to:

  • diagnostic and laboratory testing;

  • specimen collection, preservation and transport;

  • laboratory selection and changes;

  • specimen routing and return labels;

  • testing limitations;

  • estimated turnaround times;

  • subscriptions and recurring payments;

  • cryopreservation and sperm storage;

  • stored payment methods and future charges;

  • telehealth and clinical services;

  • healthcare referrals;

  • services purchased through third parties;

  • SAGE and analytical products;

  • cancellations, refunds and replacements;

  • intellectual property;

  • liability;

  • dispute resolution; and

  • certain jurisdiction-specific consumer rights.

Nothing in these Terms excludes, restricts or modifies a consumer, healthcare or other legal right that applicable law does not permit Sapyen to exclude, restrict or modify.

1. About Sapyen

Sapyen provides reproductive-health, male fertility, diagnostic, laboratory, specimen-collection, specimen-preservation, cryopreservation, digital-health, analytics, healthcare-support, telehealth-access, referral and related products and services.

Depending on the product, country and manner in which you access Sapyen, a service may involve one or more of:

  • Sapyen;

  • a Sapyen subsidiary or affiliate;

  • an independent laboratory;

  • a specialist testing laboratory;

  • a healthcare professional;

  • a medical practice;

  • a fertility clinic;

  • a telehealth provider;

  • a genetic testing company;

  • a cryopreservation or storage provider;

  • a healthcare platform;

  • a courier;

  • a fulfilment provider;

  • a technology provider;

  • a payment provider; or

  • another organisation engaged in providing or supporting the service.

The precise organisations involved may change from time to time.

2. Meaning of Sapyen

For purposes of these Terms, “Sapyen,” “we,” “us” and “our” mean Sapyen and the Sapyen entity, subsidiary or affiliate responsible for supplying the relevant product or service.

The applicable entity may be identified:

  • at checkout;

  • on an invoice;

  • in an order confirmation;

  • through a clinic or partner arrangement;

  • in service-specific documentation; or

  • through another communication relating to the service.

Different Sapyen entities may provide different portions of a service.

3. Scope of these Terms

These Terms apply, where relevant, to:

  • Sapyen websites;

  • Sapyen test kits;

  • semen analysis;

  • post-vasectomy semen analysis;

  • DNA fragmentation testing;

  • antisperm antibody testing;

  • epigenetic or methylation testing;

  • genetic and carrier-screening services offered through Sapyen;

  • hormonal or other diagnostic services;

  • Sapyen Complete and other test bundles;

  • future diagnostic tests;

  • specimen-preservation products;

  • specimen transport;

  • cryopreservation;

  • sperm freezing;

  • sperm storage;

  • patient portals;

  • clinician and clinic portals where no separate agreement applies;

  • SAGE;

  • SpermAge;

  • SpermRank;

  • other scores, rankings and analytical products;

  • subscriptions;

  • memberships;

  • repeat-testing programs;

  • telehealth;

  • healthcare consultations;

  • referrals;

  • partner-distributed tests;

  • co-branded services;

  • digital content;

  • educational products;

  • research interfaces; and

  • other Sapyen services that reference these Terms.

4. Additional terms and consents

Certain services may also be governed by additional documents.

These may include:

  • diagnostic testing consents;

  • informed consent forms;

  • genetic testing consents;

  • telehealth consents;

  • research consents;

  • laboratory documentation;

  • cryopreservation agreements;

  • storage agreements;

  • disposition instructions;

  • partner-specific terms;

  • subscription disclosures;

  • patient information sheets;

  • instructions for use;

  • privacy notices; and

  • jurisdiction-specific notices.

Those documents form part of the agreement for the relevant service where applicable.

If there is a direct inconsistency:

  1. a legally required informed consent controls regarding the subject matter of that consent;

  2. a specific cryopreservation or storage agreement controls regarding storage and disposition of reproductive material;

  3. service-specific terms control regarding that particular service;

  4. these Terms otherwise apply; and

  5. Sapyen's Privacy Policy governs Sapyen's handling of Personal Information.

5. Acceptance

You may accept these Terms by:

  • selecting an acceptance button;

  • checking an acceptance box;

  • completing a purchase after being notified that these Terms apply;

  • activating a Sapyen product after being presented with these Terms;

  • submitting a specimen after being presented with these Terms;

  • creating an applicable account;

  • agreeing through an electronic workflow; or

  • otherwise affirmatively indicating acceptance.

Public portions of Sapyen websites may also be subject to the website-use provisions of these Terms.

6. Eligibility and legal capacity

By entering into these Terms, you represent that:

  • you have legal capacity to enter into the agreement;

  • you meet applicable age requirements;

  • you will use the service lawfully;

  • information you knowingly provide will be materially accurate; and

  • you satisfy any eligibility requirements disclosed for the relevant service.

7. Age requirements

Unless expressly stated otherwise, Sapyen's direct-to-consumer diagnostic services are intended for adults.

Services involving a minor may be available where legally and clinically appropriate, including through:

  • a parent;

  • guardian;

  • healthcare professional;

  • authorised clinical program; or

  • another legally permitted pathway.

Additional consent requirements may apply.

8. Purchasing for another person

You may be permitted to purchase an unused Sapyen product for another person.

The purchaser does not automatically become entitled to:

  • activate the test;

  • submit a specimen;

  • access results;

  • access the tested person's account; or

  • receive the tested person's health information.

The individual being tested may be required to independently complete activation, identity verification, consent and other applicable requirements.

9. Personal nature of diagnostic services

Once a test has been:

  • activated;

  • registered to an individual;

  • associated with a specimen;

  • partially performed; or

  • otherwise personalised,

it may not be transferred to another person except where Sapyen expressly permits the transfer.

10. Specimen ownership and authority

Unless the relevant service expressly provides otherwise, a specimen submitted through your account must be:

  • your own specimen;

  • a specimen lawfully submitted by an authorised representative; or

  • another specimen Sapyen has expressly agreed to accept.

You must not knowingly:

  • submit another person's specimen under your identity;

  • substitute specimens;

  • falsify specimen ownership;

  • intentionally adulterate a specimen;

  • submit a specimen without required authority; or

  • use Sapyen for an unauthorised investigative or forensic purpose.

11. Not a forensic chain-of-custody service

Unless expressly offered as such, Sapyen services are not intended for:

  • forensic analysis;

  • paternity testing;

  • criminal investigation;

  • legal identity verification;

  • law-enforcement testing;

  • immigration identity testing;

  • employment screening;

  • insurance underwriting;

  • evidentiary testing; or

  • another purpose requiring a formal forensic chain of custody.

12. Service availability

Sapyen products may vary by:

  • country;

  • state;

  • province;

  • regulatory status;

  • laboratory availability;

  • clinical availability;

  • age;

  • location;

  • specimen type;

  • service provider; and

  • other relevant factors.

Availability at one time does not guarantee future availability.

13. Changes to services

Subject to applicable law and existing contractual commitments, Sapyen may:

  • introduce new services;

  • modify services;

  • discontinue services;

  • change laboratories;

  • change laboratory networks;

  • change fulfilment providers;

  • change couriers;

  • change telehealth providers;

  • change storage providers;

  • change technology providers;

  • change analytical methodologies;

  • change reference ranges;

  • change specimen-routing arrangements;

  • change geographic availability; and

  • otherwise modify how services are delivered.

Sapyen will provide an appropriate remedy where a material prepaid service can no longer be provided and applicable law requires a remedy.

14. Orders

Submitting an order constitutes an offer to purchase the applicable service.

Sapyen may accept or decline an order.

An automated acknowledgement does not necessarily constitute final acceptance where further:

  • eligibility review;

  • regulatory review;

  • payment verification;

  • clinical review; or

  • operational processing

is required.

15. Order cancellation by Sapyen

Sapyen may cancel or decline an order where reasonably necessary because of:

  • product unavailability;

  • laboratory availability;

  • regulatory restrictions;

  • payment failure;

  • a material pricing error;

  • fraud concerns;

  • duplicate ordering;

  • service eligibility;

  • shipping restrictions;

  • safety concerns;

  • misuse; or

  • inability to provide the relevant service.

Any refund legally required will be provided.

16. Pricing

The applicable price is the price or pricing arrangement communicated to you in connection with the service you purchase.

Pricing does not need to be displayed in every location where the product or service is described.

Depending on how a service is offered, pricing may be communicated through:

  • the Sapyen website;

  • checkout;

  • an order page;

  • an account;

  • email;

  • an invoice;

  • an order confirmation;

  • a quotation;

  • a proposal;

  • telephone;

  • a Sapyen representative;

  • a clinic;

  • a healthcare professional;

  • a Sapyen partner;

  • a telehealth interaction; or

  • another sales or communication channel.

Where applicable law requires pricing or payment information to be given in a particular form, Sapyen will comply with that requirement.

17. Individually communicated pricing

Sapyen may provide pricing specifically to an individual or organisation.

For example, pricing may be quoted:

  • over the telephone;

  • by email;

  • through a healthcare provider;

  • through a partner;

  • in a proposal; or

  • through another direct communication.

Where you subsequently purchase or authorise the relevant service on the basis of that pricing, the communicated pricing forms part of your agreement.

18. Prices may vary

Pricing may vary according to:

  • market;

  • currency;

  • location;

  • clinic;

  • partner;

  • test;

  • laboratory;

  • membership;

  • subscription;

  • promotion;

  • storage period;

  • payment structure;

  • fulfilment route;

  • bundled services;

  • commercial relationship; or

  • other relevant factors.

A price offered in one circumstance does not create an entitlement to the same price in another circumstance.

19. Taxes and fees

The price displayed or communicated may include or exclude:

  • GST;

  • VAT;

  • sales taxes;

  • duties;

  • shipping;

  • fulfilment;

  • storage;

  • consultation fees; and

  • other applicable charges,

as disclosed or required by applicable law.

20. Payment

By providing a payment method, you represent that you are authorised to use it.

You authorise Sapyen and its payment providers to collect amounts that you have agreed are payable under the applicable service.

21. Payment processors

Payments may be processed by independent payment processors.

Sapyen may receive a token or other payment credential rather than your complete payment-card number.

The payment processor may independently apply its own terms and privacy practices.

22. Stored payment methods

Some Sapyen services involve:

  • future payments;

  • deferred payments;

  • recurring payments;

  • storage charges;

  • renewal charges;

  • subscriptions; or

  • charges that become due after an initial period.

Where applicable, you authorise Sapyen and its payment provider to securely retain a payment credential associated with your chosen payment method.

That payment credential may subsequently be used to collect amounts that become payable under the pricing arrangement you accepted.

23. Preauthorisation and payment verification

Sapyen or its payment provider may:

  • verify your card;

  • perform an authorisation;

  • perform a preauthorisation;

  • place a temporary hold;

  • verify available credit; or

  • otherwise confirm that a payment method is valid.

A preauthorisation or payment verification is not necessarily a completed payment.

24. Future and deferred charges

Some Sapyen products involve an initial payment that is lower than the total amount that may subsequently become payable.

If you purchase such a service, you authorise Sapyen to charge the stored payment method when the relevant amount becomes due under the pricing terms communicated to you.

A future charge may occur:

  • after a cancellation period expires;

  • when laboratory processing begins;

  • when cryopreservation occurs;

  • when storage begins;

  • on a specified future date;

  • upon renewal;

  • following another disclosed milestone; or

  • as otherwise communicated in the applicable pricing arrangement.

Sapyen is not required to ask you to manually re-enter your card details before each authorised future charge.

25. Scope of payment authority

These Terms do not give Sapyen an unrestricted right to charge arbitrary amounts.

Amounts charged must arise from:

  • the pricing arrangement you accepted;

  • a subsequent purchase you authorised;

  • a renewal arrangement you accepted;

  • an agreed storage arrangement;

  • applicable taxes or charges; or

  • another lawful payment obligation.

26. Failed payments

If a payment fails, Sapyen may:

  • retry the payment;

  • contact you;

  • request another payment method;

  • issue an invoice;

  • suspend non-essential paid features;

  • prevent future purchases;

  • cancel a future service; or

  • seek lawful recovery of an unpaid amount.

Biological material subject to cryogenic storage will not be disposed of solely under this section. Any disposition of stored reproductive material is governed by the applicable storage agreement, consent and law.

27. Promotions

Promotions may be subject to:

  • expiry dates;

  • eligible products;

  • geographic restrictions;

  • customer eligibility;

  • maximum usage;

  • exclusions;

  • minimum purchase values; or

  • other conditions.

Unless stated otherwise, promotions:

  • cannot be combined;

  • cannot be exchanged for cash;

  • cannot generally be applied retrospectively; and

  • may be withdrawn before use.

28. Shipping of test kits

Sapyen may use one or more fulfilment providers and couriers.

Shipping methods may vary according to:

  • market;

  • location;

  • product;

  • courier availability;

  • operational needs;

  • laboratory destination;

  • time of year; and

  • other factors.

29. Delivery estimates

Delivery dates and shipping timelines are estimates unless Sapyen expressly states that a specific deadline is guaranteed.

A delivery estimate is not ordinarily an essential term or guaranteed contractual deadline.

30. Shipping delays

A shipping delay does not by itself constitute a breach of these Terms or entitle you to a refund.

Delays may occur because of:

  • courier operations;

  • weather;

  • customs;

  • public holidays;

  • strikes;

  • remote locations;

  • incorrect address information;

  • natural disasters;

  • infrastructure interruption;

  • operational disruption;

  • high demand; or

  • other circumstances.

Mandatory rights concerning delivery within a legally required or reasonable period remain unaffected.

31. Delivery address

You are responsible for providing a materially accurate delivery address.

If a kit must be:

  • reshipped;

  • redirected;

  • replaced; or

  • otherwise refulfilled

because the address you supplied was materially incorrect or incomplete, Sapyen may charge reasonable additional costs where legally permitted.

32. Delivery investigations

If you report that an order was not received, Sapyen may investigate using:

  • carrier tracking;

  • delivery scans;

  • photographs;

  • courier GPS or location information where available;

  • fulfilment records;

  • warehouse records;

  • address information; and

  • communications with you.

You may be asked to reasonably cooperate with the investigation.

33. Inspection after delivery

You should inspect your kit reasonably promptly after delivery.

If you believe that:

  • an item is missing;

  • an item is damaged;

  • a component is defective;

  • you received the wrong product; or

  • packaging has been materially compromised,

you should notify Sapyen as soon as reasonably practicable.

Prompt notification helps Sapyen preserve relevant:

  • photographs;

  • fulfilment records;

  • batch information;

  • courier evidence;

  • warehouse records; and

  • packaging evidence.

34. Evidence concerning damaged or incomplete kits

Sapyen may reasonably ask you to:

  • provide photographs;

  • retain the packaging;

  • identify batch or lot information;

  • describe the issue;

  • provide the kit identifier;

  • return an unused component where appropriate; or

  • provide other information reasonably necessary to investigate.

This does not remove any statutory right that cannot lawfully be excluded.

35. Single-use components

Unless expressly stated otherwise, collection and diagnostic components are intended for a single use.

They should not be reused where the instructions identify them as single-use.

36. Storage before use

You are responsible for storing the product in accordance with the instructions supplied with it.

Improper storage may affect:

  • safety;

  • preservation;

  • product integrity;

  • analytical performance; or

  • test eligibility.

37. Expiry

Some products and components have expiry dates.

You are responsible for using the product within its stated validity period.

Sapyen is not ordinarily required to replace or refund an otherwise conforming product simply because:

  • you did not use it before expiry;

  • you forgot to use it;

  • you delayed testing;

  • your plans changed; or

  • you no longer require the service.

This does not apply where the product was defective, expired when supplied, or otherwise failed to satisfy an applicable mandatory consumer guarantee.

38. Collection instructions

You must follow the applicable collection and handling instructions as carefully as reasonably practicable.

Instructions may relate to:

  • preparation;

  • abstinence;

  • collection;

  • completeness;

  • containers;

  • timing;

  • transfer of specimen;

  • preservation media;

  • mixing;

  • temperature;

  • packaging;

  • labelling;

  • activation;

  • return shipping; and

  • other requirements.

39. Complete specimen collection

Certain tests depend on the collection of a complete ejaculate or another specified specimen.

Failure to collect the specimen as instructed can materially affect test results.

Where asked, you should disclose relevant collection issues.

40. Patient or user error

User error may include:

  • using the wrong container;

  • failing to use a required component;

  • using a preservation component incorrectly;

  • spilling a material part of a specimen;

  • contamination;

  • insufficient specimen volume;

  • incorrect labelling;

  • failing to activate a kit;

  • inaccurate collection information;

  • using an expired product;

  • failing to follow storage instructions;

  • using the wrong return packaging;

  • using an obsolete return label after being instructed to use a replacement;

  • substantial delay in returning the specimen; or

  • another material departure from instructions.

Where a service cannot be completed because of user error, Sapyen is not ordinarily required to provide a free:

  • replacement;

  • recollection;

  • retest; or

  • refund,

unless applicable law requires otherwise.

Sapyen may elect to offer a discounted or complimentary remedy.

41. Laboratory selection

Sapyen may determine which laboratory or laboratories perform testing.

Unless a particular laboratory has been expressly promised as a material feature of your purchase, purchasing a Sapyen test does not create a contractual right to have your specimen tested at a particular laboratory.

42. Right to change laboratories

Sapyen may change the laboratory assigned to your order at any time, including:

  • before a kit is fulfilled;

  • after a kit has been fulfilled;

  • after a kit has been delivered to you;

  • before specimen collection;

  • after a return label has been issued; or

  • during the operational processing of your order,

where reasonably appropriate.

A laboratory may be changed because of:

  • capacity;

  • turnaround;

  • geography;

  • regulatory requirements;

  • accreditation;

  • test availability;

  • operational requirements;

  • laboratory performance;

  • quality;

  • logistics;

  • technology;

  • service continuity;

  • cost;

  • contractual arrangements; or

  • another legitimate operational consideration.

Sapyen does not need to obtain separate permission from you merely to substitute an appropriate laboratory where the ordered service remains materially the same.

43. Multiple laboratories

Different components of one order may be performed by different laboratories.

For example:

  • semen analysis may be performed at one laboratory;

  • genetic testing may be performed at another;

  • DNA fragmentation may be performed by a specialist laboratory;

  • epigenetic testing may be performed elsewhere; and

  • cryopreservation may be performed by another provider.

Specimens, aliquots, extracted material or data may therefore move between participating providers as required.

44. Different laboratory methods

Where scientifically, clinically and regulatorily appropriate, Sapyen may use a different validated or accepted method from the method previously used for another Sapyen patient or another Sapyen test.

Methods can differ in:

  • equipment;

  • laboratory workflow;

  • calculation;

  • analytical technique;

  • reference values; and

  • reporting format.

If a particular methodology was expressly sold to you as a defining feature of the test, Sapyen will not substitute a materially different methodology without appropriate notice or consent where required.

45. Laboratory routing

Sapyen determines the appropriate return destination for a specimen.

The destination printed in a kit at the time of fulfilment is not necessarily permanent.

Operational circumstances may require a specimen to be routed to a different:

  • laboratory;

  • accessioning location;

  • processing centre;

  • logistics hub; or

  • storage facility.

46. Replacement and revised return labels

Sapyen may issue a new or replacement specimen-return label at any time.

This includes after:

  • your kit has been dispatched;

  • your kit has been delivered;

  • the original return label has been printed;

  • the laboratory allocation has changed; or

  • another operational change has occurred.

A replacement label may direct your specimen to a destination different from the one shown on the label originally included in your kit.

47. Latest return instructions control

If Sapyen provides you with revised return instructions or a replacement label before you dispatch your specimen, the most recent instructions supersede earlier instructions to the extent of any inconsistency.

You should use the most recent return label or routing instruction supplied by Sapyen.

48. Delivery of revised labels

A replacement return label or revised routing instruction may be provided through:

  • email;

  • your account;

  • a patient portal;

  • SMS;

  • customer support;

  • a clinic;

  • a healthcare partner; or

  • another reasonable electronic or physical communication method.

You may need to:

  • print the new label;

  • present a digital label to a carrier;

  • use different packaging;

  • attend a different drop-off location; or

  • follow another updated instruction.

49. Use of an outdated label

If Sapyen has reasonably notified you before specimen dispatch that a return label has been replaced and you nevertheless use the superseded label, any resulting:

  • delay;

  • rerouting;

  • additional shipping;

  • inability to test;

  • deterioration; or

  • need for recollection

may be treated as resulting from failure to follow current return instructions.

Sapyen may still attempt to recover or reroute the specimen but cannot guarantee that this will be possible.

50. Labels used before notice

If you dispatched your specimen using the then-current instructions before receiving a revised routing instruction, Sapyen will not treat the use of that label as patient error.

Sapyen may nevertheless:

  • intercept the shipment where possible;

  • reroute the specimen;

  • transfer it between facilities;

  • arrange secondary transport; or

  • take another reasonable operational step.

51. Specimen rerouting

You authorise Sapyen and the organisations involved in specimen transport to reroute, redirect or transfer your specimen where reasonably necessary to provide the ordered service.

This may include transferring the specimen from one participating facility to another.

52. Specimen transport

Specimen return is commonly performed by independent couriers.

Transport inherently involves operational risks including:

  • delay;

  • missed scans;

  • routing errors;

  • flight disruption;

  • weather;

  • temperature exposure;

  • customs;

  • vehicle disruption;

  • carrier-system outages; and

  • other transport events.

53. Transit timelines

Any expected specimen-transit period is an estimate unless expressly stated to be guaranteed.

A specimen arriving outside an expected transit period does not automatically mean it cannot be tested.

The laboratory or Sapyen may determine whether testing remains appropriate.

54. Delays generally

Unless Sapyen expressly describes a particular timeline as guaranteed, estimated timelines for:

  • fulfilment;

  • delivery;

  • specimen return;

  • accessioning;

  • laboratory testing;

  • specialist testing;

  • clinical review;

  • report release;

  • telehealth;

  • cryopreservation; or

  • another service

are estimates rather than contractual conditions.

An ordinary delay does not by itself constitute:

  • breach of contract;

  • negligence;

  • test failure;

  • grounds for cancellation;

  • grounds for a refund; or

  • grounds for compensation.

This provision is subject to any mandatory legal requirement concerning performance within a specified or reasonable time.

55. Factors affecting turnaround

Turnaround may be affected by:

  • sample condition;

  • repeat analysis;

  • laboratory capacity;

  • laboratory quality review;

  • specialist interpretation;

  • transport;

  • public holidays;

  • weekends;

  • staff availability;

  • instrument maintenance;

  • assay availability;

  • reagent availability;

  • regulatory requirements;

  • technical failures;

  • clinical review;

  • result verification;

  • unusual findings;

  • partner processing;

  • external laboratory operations; or

  • other relevant factors.

56. No consequential entitlement from delay alone

To the extent permitted by law, a delay alone does not entitle you to compensation for consequences such as:

  • appointment changes;

  • treatment timing;

  • travel;

  • fertility-treatment scheduling;

  • emotional distress;

  • missed personal plans; or

  • other consequential effects

unless Sapyen is legally liable for those losses under applicable law.

57. Specimen acceptance and rejection

Submission of a specimen does not guarantee that testing can be completed.

A specimen may be:

  • accepted;

  • conditionally accepted;

  • partially tested;

  • rejected;

  • held for review;

  • rerouted;

  • recollected; or

  • otherwise managed

according to the applicable clinical, laboratory and operational circumstances.

58. Rejection criteria

Specimen acceptance or rejection criteria may include considerations such as:

  • specimen age;

  • sample condition;

  • collection completeness;

  • sample volume;

  • contamination;

  • transport conditions;

  • identification;

  • packaging;

  • preservation;

  • temperature;

  • leakage;

  • laboratory methodology; and

  • other analytical requirements.

59. Changes to rejection criteria

Sapyen or an applicable laboratory may update specimen criteria from time to time based on:

  • new validation data;

  • real-world performance;

  • regulatory requirements;

  • laboratory methodology;

  • quality review;

  • scientific evidence;

  • assay development; or

  • operational experience.

The criteria applicable at the time the specimen is assessed may therefore differ from historical criteria.

60. Testing outside routine operational criteria

Sapyen or a laboratory may elect to test a specimen even if it falls outside a routine operational criterion where testing is considered scientifically, clinically or operationally appropriate.

Testing a specimen in such circumstances does not guarantee that:

  • every assay can be completed;

  • every measurement will be reportable;

  • every result will be communicated to the patient;

  • the result will be treated as clinically valid for every purpose; or

  • future specimens outside the same criterion will also be accepted.

61. Qualified, partial or withheld results

Where appropriate, a result may be:

  • qualified;

  • caveated;

  • partially reported;

  • repeated;

  • withheld pending review;

  • cancelled;

  • designated unsuitable for clinical reporting; or

  • otherwise handled according to laboratory and clinical judgment.

62. Laboratory services

Laboratory analysis may be performed by:

  • Sapyen;

  • an affiliated laboratory;

  • an independent laboratory;

  • a specialist laboratory;

  • a contracted laboratory;

  • a hospital laboratory;

  • a pathology service; or

  • another appropriately authorised diagnostic provider.

63. Independent laboratories

An independent laboratory may have its own:

  • accreditation;

  • regulatory responsibilities;

  • professional duties;

  • quality system;

  • retention requirements;

  • reporting obligations; and

  • legal responsibilities.

Sapyen remains responsible only to the extent required by applicable law and the particular contractual arrangement.

64. Biological variation

Semen and other biological measurements naturally vary.

Results may be influenced by factors such as:

  • collection;

  • abstinence;

  • illness;

  • fever;

  • medication;

  • treatment;

  • lifestyle;

  • environment;

  • heat;

  • stress;

  • normal biological variability; and

  • timing.

A result from one specimen does not guarantee the same result from another specimen.

65. Point-in-time measurement

A laboratory result generally describes the specimen analysed at the relevant time.

It does not guarantee:

  • future fertility;

  • future infertility;

  • natural conception;

  • pregnancy;

  • live birth;

  • IVF success;

  • IUI success;

  • treatment success;

  • future semen quality; or

  • future laboratory measurements.

66. Limitations of diagnostic testing

No laboratory test is perfect.

Testing may be affected by:

  • biological variability;

  • analytical variability;

  • specimen limitations;

  • collection limitations;

  • transport;

  • measurement uncertainty;

  • technical limitations;

  • false positive findings;

  • false negative findings;

  • reference-population limitations;

  • current scientific knowledge; and

  • human or technical error.

67. Fertility is multifactorial

A normal semen or sperm-health result does not guarantee fertility.

An abnormal result does not mean conception is necessarily impossible.

Reproductive outcomes can depend on factors involving both partners and other biological or clinical circumstances.

68. Reference ranges

Reference ranges, decision thresholds and interpretive frameworks may change as:

  • professional guidelines evolve;

  • laboratory standards change;

  • scientific evidence develops;

  • populations change;

  • methodology changes; or

  • Sapyen develops improved analytical systems.

69. Results are not a complete medical assessment

Unless expressly stated otherwise, a laboratory report is not a complete medical diagnosis or complete fertility assessment.

You should seek appropriate clinical advice where a result:

  • concerns you;

  • is abnormal;

  • is unexpected;

  • may affect treatment; or

  • may influence a significant healthcare decision.

70. Customer support is not medical advice

Sapyen customer-support personnel may provide:

  • operational assistance;

  • collection assistance;

  • logistics support;

  • general product information;

  • general educational information;

  • report-navigation assistance; and

  • account support.

Unless the individual is separately acting as a qualified healthcare professional within an applicable clinical service, customer-support communications are not personal medical advice.

71. Corrected and amended reports

Laboratory reports may occasionally need to be:

  • corrected;

  • amended;

  • clarified;

  • supplemented;

  • withdrawn; or

  • reissued.

The current valid report supersedes an earlier version to the extent indicated.

72. Notification of corrections

Where appropriate, Sapyen may notify:

  • you;

  • your clinic;

  • an ordering provider;

  • a referring provider;

  • a partner platform;

  • a telehealth clinician; or

  • another recipient of the original report

that an amended or corrected result is available.

73. Results delivery

Results may be delivered through:

  • a Sapyen patient portal;

  • a Sapyen account;

  • email;

  • a clinic;

  • a healthcare professional;

  • a partner application;

  • a healthcare platform;

  • an electronic health record; or

  • another appropriate delivery method.

74. Results to referring providers

Where your test was:

  • ordered;

  • referred;

  • arranged;

  • recommended;

  • facilitated; or

  • funded

through a clinician or healthcare organisation, Sapyen may provide relevant information and results to that organisation where permitted by applicable law and the applicable privacy framework.

This may include:

  • physicians;

  • fertility specialists;

  • GPs;

  • nurse practitioners;

  • physician assistants;

  • genetic counsellors;

  • clinics;

  • hospitals;

  • health networks; and

  • other referring or treating providers.

75. Patient-directed sharing

You may ask Sapyen to provide information to another healthcare professional or authorised recipient.

Sapyen may reasonably verify:

  • your identity;

  • the request;

  • the recipient;

  • contact details; or

  • the scope of authorisation.

76. Communications including other people

If you deliberately include another person in an email, message or other communication concerning your testing or healthcare, Sapyen may reasonably understand that you want that person included in the conversation.

For example, if you email Sapyen about your report and copy:

  • a spouse;

  • partner;

  • clinician;

  • nurse practitioner; or

  • another person,

Sapyen may reply within that correspondence and discuss information reasonably relevant to the subject of the conversation.

This does not provide the other person with unlimited or permanent authority over your entire Sapyen record.

77. Products purchased through third parties

A Sapyen test may be purchased, accessed, funded or arranged through another organisation.

Examples include:

  • a clinic;

  • fertility provider;

  • healthcare platform;

  • health membership;

  • telehealth service;

  • diagnostic company;

  • employer health program where permitted;

  • insurer or benefits program where applicable; or

  • another Sapyen partner.

78. Integrated services

Where Sapyen is one component of an integrated healthcare service, information may need to pass between Sapyen and the other organisation to provide that service.

This may include:

  • identity information;

  • contact information;

  • order information;

  • specimen status;

  • laboratory status;

  • results;

  • reports;

  • health information;

  • SAGE outputs; and

  • other relevant information.

Such information handling is governed by applicable privacy notices, agreements and law.

79. Returning results to partner platforms

If you obtained a Sapyen service through a platform that is responsible for providing the result back to you, Sapyen may provide your Personal Information and Health Information to that platform as reasonably necessary to deliver the service.

The platform may independently apply its own privacy terms to its handling of the information.

80. Electronic integrations

Sapyen may integrate with:

  • electronic medical records;

  • electronic health records;

  • laboratory information systems;

  • patient portals;

  • clinician portals;

  • healthcare APIs;

  • partner software;

  • referral systems;

  • telehealth systems; and

  • other healthcare technology.

Information may be transferred automatically through those integrations.

81. Bundled services

A Sapyen package may contain products or services provided by different organisations.

For example, a bundle may contain:

  • Sapyen semen analysis;

  • genetic testing from another company;

  • telehealth;

  • storage;

  • specialist laboratory testing; or

  • another service.

Different components may be:

  • processed separately;

  • returned separately;

  • billed separately;

  • subject to separate consents; and

  • reported independently.

82. Independent bundled providers

Unless expressly stated otherwise, each independent company participating in a bundle remains responsible for the professional or clinical service it independently provides.

Sapyen is not responsible for another organisation's:

  • clinical interpretation;

  • laboratory result;

  • billing;

  • professional services; or

  • independent conduct

except where applicable law imposes responsibility on Sapyen.

83. SAGE and analytical services

SAGE and related Sapyen analytical products may use:

  • laboratory measurements;

  • demographic information;

  • health information;

  • historical testing;

  • reference populations;

  • statistical models;

  • algorithms;

  • machine learning;

  • artificial intelligence; and

  • other analytical systems.

84. SAGE outputs

SAGE may provide:

  • scores;

  • rankings;

  • percentiles;

  • SpermAge;

  • SpermRank;

  • reference comparisons;

  • trends;

  • correlations;

  • predictions;

  • educational information;

  • personalised insights; and

  • other derived outputs.

Unless expressly stated otherwise, these outputs are not independent medical diagnoses.

85. SpermAge

SpermAge is an analytical measure.

It should not be interpreted as necessarily representing:

  • your chronological age;

  • your general biological age;

  • life expectancy; or

  • a diagnosis of disease.

86. SpermRank

SpermRank or another percentile measure describes a comparative position within an applicable reference population.

A percentile is not automatically a probability of:

  • conception;

  • pregnancy;

  • fertility;

  • IVF success; or

  • live birth.

87. Changing reference populations

Reference populations may evolve.

Sapyen may:

  • add data;

  • remove unsuitable data;

  • segment populations;

  • change inclusion criteria;

  • update statistics;

  • recalibrate models;

  • use new datasets;

  • combine datasets; and

  • improve methodology.

A score generated at one point may therefore differ from a score subsequently calculated from the same underlying result.

88. SAGE updates

Sapyen may update:

  • algorithms;

  • user interfaces;

  • methodologies;

  • model parameters;

  • reference populations;

  • scoring systems;

  • explanations;

  • features; and

  • functionality.

Sapyen is not required to indefinitely preserve every historical version.

89. Proprietary systems

Use of SAGE does not give you a right to inspect or receive proprietary:

  • source code;

  • algorithms;

  • model weights;

  • training datasets;

  • reference datasets;

  • trade secrets;

  • analytical methods; or

  • other confidential intellectual property

except where disclosure is legally required.

90. Telehealth

Sapyen may provide access to healthcare consultations through:

  • Sapyen-affiliated clinicians;

  • contracted clinicians;

  • independent clinicians;

  • medical practices;

  • telehealth networks; or

  • other healthcare organisations.

91. Clinician access to your records

When you request or purchase a Sapyen-linked clinical consultation, relevant Personal Information and Health Information may be provided to the healthcare professional conducting the consultation.

This may include:

  • medical history;

  • reproductive-health information;

  • questionnaires;

  • test results;

  • reports;

  • previous results;

  • SAGE information; and

  • other information relevant to the consultation.

92. Clinical independence

Healthcare professionals exercise their own professional judgment.

Sapyen does not guarantee that a clinician will:

  • agree with your interpretation;

  • provide a diagnosis;

  • recommend a specific intervention;

  • prescribe medication;

  • order another test;

  • recommend fertility treatment; or

  • make a particular referral.

93. Clinician-patient relationship

Purchasing a Sapyen test does not itself create a clinician-patient relationship.

A clinical relationship exists only where established through the applicable clinical service and law.

94. Telehealth eligibility

A clinician may determine that telehealth cannot appropriately be used because of:

  • location;

  • licensing restrictions;

  • need for physical examination;

  • clinical complexity;

  • identity-verification issues;

  • emergency symptoms;

  • incomplete information; or

  • another professional reason.

95. Telehealth is not emergency care

Sapyen's telehealth and customer-support channels are not emergency medical services.

If you believe you are experiencing a medical emergency, seek appropriate local emergency care.

96. Referrals

Sapyen may connect users with:

  • fertility clinics;

  • physicians;

  • urologists;

  • nurse practitioners;

  • genetic counsellors;

  • reproductive specialists; or

  • other providers.

A referral does not guarantee:

  • appointment availability;

  • acceptance as a patient;

  • treatment;

  • clinical outcome;

  • insurance coverage;

  • price; or

  • satisfaction with the provider.

97. Independent referred providers

An independently operated provider is responsible for its own:

  • clinical advice;

  • treatment;

  • scheduling;

  • pricing;

  • professional conduct;

  • medical records;

  • billing; and

  • legal obligations.

98. Cryopreservation and sperm freezing

Cryopreservation and sperm storage differ from ordinary diagnostic testing.

A cryopreservation service may involve:

  • collection;

  • specimen transport;

  • laboratory receipt;

  • assessment;

  • processing;

  • aliquoting;

  • preparation;

  • freezing;

  • cryogenic storage;

  • storage administration;

  • future release;

  • transfer;

  • thawing;

  • disposal; and

  • other activities.

99. Separate cryopreservation documentation

Cryopreservation may require additional agreements or consents addressing:

  • storage;

  • ownership;

  • disposition;

  • renewal;

  • payment;

  • transfer;

  • release;

  • destruction;

  • death;

  • incapacity;

  • non-payment;

  • infectious-disease testing;

  • future use; and

  • other matters.

Those documents control concerning the physical storage and disposition of reproductive material where applicable.

100. Cryopreservation price structures

Cryopreservation may involve an initial amount that is substantially lower than the full cost of the service.

For example, Sapyen may offer:

  • $1;

  • £1;

  • another nominal amount;

  • an introductory amount; or

  • a promotional initial payment.

Unless expressly stated otherwise, such an initial amount does not mean the entire cryopreservation or storage service costs that amount.

101. Communication of cryopreservation pricing

The full pricing arrangement may be communicated through:

  • the website;

  • checkout;

  • email;

  • telephone;

  • quotation;

  • invoice;

  • clinic;

  • partner;

  • account;

  • order confirmation; or

  • another applicable sales channel.

Sapyen does not need to reproduce the full cryopreservation price in every communication concerning the service.

102. Cryopreservation cancellation period

Unless a longer period is required by applicable law or offered for a particular transaction, Sapyen provides a 7-calendar-day cancellation period from purchase for eligible cryopreservation or sperm-freezing purchases.

For consumers in the United Kingdom, the applicable cancellation period will be at least 14 calendar days where required by law.

For consumers in the European Economic Area, applicable statutory withdrawal rights, including a 14-day period where required, will be honoured.

If applicable law gives you a longer mandatory period, that longer period applies.

103. How to cancel cryopreservation

To cancel during an applicable cancellation period, you must clearly communicate that you wish to cancel using a cancellation method made available by Sapyen.

Sapyen may provide cancellation through:

  • email;

  • account functionality;

  • customer support;

  • an online form; or

  • another method.

104. Cancellation before expiry of the period

If you validly cancel within the applicable period:

  • future charges associated with the cancelled service will ordinarily not become payable;

  • any refund legally or contractually due will be processed; and

  • Sapyen will take appropriate steps regarding the service.

If you specifically requested that substantive services begin during a statutory cooling-off period, Sapyen may retain or charge an amount for services already supplied where applicable law permits.

105. Failure to cancel cryopreservation

If you do not cancel within the applicable cancellation period, the applicable cryopreservation and storage charges become payable and, subject to mandatory law, no change-of-mind refund will be issued.

This applies even if you subsequently:

  • change your mind;

  • decide not to freeze sperm;

  • decide not to use the service;

  • change fertility plans;

  • choose another provider;

  • fail to return a specimen; or

  • no longer require cryopreservation.

106. Authority to charge full cryopreservation amount

By purchasing a deferred-payment cryopreservation service, you authorise Sapyen to retain the applicable payment credential and charge the full applicable amount when it becomes payable under the pricing terms communicated to you.

The subsequent payment may be processed without Sapyen requiring you to re-enter your card information.

107. Timing of cryopreservation charges

Depending on the offer, payment may become due:

  • when the cancellation period expires;

  • on a disclosed date;

  • when laboratory processing begins;

  • when freezing occurs;

  • when storage begins;

  • at another disclosed milestone; or

  • as otherwise stated in the applicable pricing arrangement.

108. Storage renewals

Cryogenic storage may involve recurring or periodic charges.

Storage may be billed:

  • annually;

  • for several years in advance;

  • as a fixed storage plan;

  • through another disclosed billing arrangement; or

  • as otherwise agreed.

Renewal pricing may differ from introductory pricing.

109. Changes to future storage pricing

Where legally permitted, Sapyen or the applicable storage provider may change future renewal pricing.

Appropriate advance notice will be provided where required.

The updated price will apply only to future periods, not retroactively to completed paid periods.

110. Diagnostic specimens are not automatically cryopreserved

Purchasing a diagnostic Sapyen test does not mean your specimen will automatically be stored for future reproductive use.

Unless you have specifically entered into an applicable cryopreservation arrangement, diagnostic specimens may be:

  • consumed during testing;

  • retained temporarily;

  • retained for permitted quality or research purposes;

  • destroyed; or

  • otherwise handled according to applicable laboratory procedures and consent.

111. No guarantee concerning frozen material

Cryopreservation reduces biological activity but does not guarantee:

  • specimen survival;

  • post-thaw motility;

  • post-thaw viability;

  • successful fertilisation;

  • embryo development;

  • pregnancy;

  • live birth; or

  • suitability for any future treatment.

112. Subscriptions and recurring services

Sapyen may offer subscriptions or recurring services for:

  • repeat testing;

  • digital services;

  • SAGE;

  • memberships;

  • storage;

  • clinical services; or

  • other products.

113. Subscription pricing

Subscription pricing and billing frequency may be communicated through any applicable sales channel described in these Terms.

The material payment terms presented in connection with your purchase form part of the subscription agreement.

114. Automatic renewal

Where you choose an automatically renewing subscription, you authorise Sapyen to charge the applicable stored payment method according to the disclosed billing arrangement until:

  • you cancel;

  • the subscription expires;

  • Sapyen terminates the subscription; or

  • another applicable event occurs.

115. Subscription cancellation

You may cancel an eligible recurring subscription using a method Sapyen makes available.

Cancellation ordinarily prevents future renewal charges rather than retrospectively cancelling a service already supplied.

116. No prorated subscription refunds

Unless required by law or expressly offered by Sapyen, cancelling during a paid billing period does not entitle you to a prorated refund for that period.

Access may continue until the end of the paid period where the service structure allows.

117. Subscription price changes

Sapyen may change the price of future subscription periods.

Where required, advance notice will be provided.

If you do not wish to continue at the new price, you may cancel before the new price applies.

118. Introductory subscription periods

A subscription may begin with:

  • a free period;

  • discounted period;

  • complimentary membership;

  • bundled period; or

  • other introductory arrangement.

Where the service subsequently becomes paid, the applicable purchase flow will identify the payment arrangement as required by law.

119. Change-of-mind refunds generally

Except where applicable law provides otherwise or Sapyen expressly offers a change-of-mind policy, you are not entitled to a refund merely because:

  • you changed your mind;

  • you no longer want testing;

  • you purchased accidentally;

  • you found another provider;

  • your fertility plans changed;

  • you no longer require the test;

  • you prefer a different product; or

  • you do not use the service.

120. Cancellation before dispatch

If an ordinary diagnostic order has not been:

  • dispatched;

  • materially fulfilled;

  • activated;

  • personalised; or

  • otherwise materially processed,

Sapyen may permit cancellation.

Any mandatory cancellation right applies independently.

121. After dispatch

Once a healthcare or diagnostic kit has been dispatched, Sapyen generally does not provide discretionary change-of-mind refunds unless:

  • Sapyen expressly agrees;

  • an applicable refund policy states otherwise; or

  • the law requires a refund.

122. Health and hygiene products

To the extent permitted by applicable law, products that:

  • are sealed;

  • are supplied for health protection or hygiene reasons; and

  • become unsuitable for return after being unsealed

may cease to qualify for change-of-mind cancellation once unsealed.

Mandatory rights regarding defective or non-conforming goods remain unaffected.

123. Accidental purchase

An accidental purchase does not automatically give rise to a refund once Sapyen has materially commenced performance.

You should contact Sapyen promptly if you believe a purchase was made in error.

124. Downgrades

Once a product has been:

  • dispatched;

  • activated;

  • associated with a specimen;

  • entered laboratory processing; or

  • otherwise materially commenced,

Sapyen is not ordinarily required to allow you to downgrade to a cheaper service and refund the difference.

125. Upgrades

Sapyen may permit an upgrade where:

  • the specimen supports the additional testing;

  • the laboratory can perform the assay;

  • processing has not advanced too far;

  • the required consent is available; and

  • applicable fees are paid.

An upgrade is not guaranteed.

126. Patient error and refunds

Where a test cannot be completed substantially because of user error, Sapyen is not ordinarily required to provide:

  • a refund;

  • a complimentary replacement;

  • a complimentary retest; or

  • a complimentary recollection.

Sapyen may nevertheless choose to do so.

127. Sapyen-attributable issues

Where Sapyen determines that an issue is attributable to Sapyen, a Sapyen-supplied component or an organisation for which Sapyen elects to take responsibility, Sapyen may choose, as appropriate, to:

  • replace the kit;

  • provide a recollection;

  • repeat testing;

  • provide a credit;

  • refund some or all of the amount paid;

  • provide another service; or

  • take another reasonable corrective action.

Except where applicable law gives you a specific remedy or choice of remedy, the selection of an appropriate remedy is at Sapyen's discretion.

128. No automatic refund because a replacement is available

Where Sapyen can appropriately remedy an issue through:

  • replacement;

  • repair;

  • recollection;

  • retesting; or

  • another reasonable method,

a cash refund is not automatically required unless applicable law provides otherwise.

129. Refund and replacement investigations

Before providing a discretionary remedy, Sapyen may investigate:

  • fulfilment;

  • shipping;

  • kit condition;

  • photographs;

  • tracking;

  • laboratory records;

  • sample condition;

  • collection information;

  • activation history;

  • communications;

  • lot or batch information; and

  • other relevant evidence.

130. Repeat collection

Where a recollection is offered, Sapyen may impose reasonable conditions including:

  • use within a specified period;

  • use by the same patient;

  • compliance with updated instructions;

  • use of a replacement return label; or

  • completion of updated activation information.

131. Refund method

Refunds will generally be returned to the original payment method where reasonably practicable.

Different arrangements may apply where:

  • a third party was merchant of record;

  • the payment method is no longer available;

  • a clinic paid for the service;

  • a credit arrangement applies; or

  • another method is appropriate.

132. Partner-purchased products

Where another organisation collected your payment, that organisation may be responsible for:

  • refund processing;

  • cancellation;

  • membership credits;

  • invoice corrections; or

  • other payment matters.

Sapyen may direct you to the organisation responsible for the transaction.

133. Insurance and reimbursement

Sapyen does not guarantee that:

  • an insurer;

  • public healthcare program;

  • employer benefit;

  • Medicare;

  • NHS funding mechanism;

  • provincial health plan;

  • health savings account;

  • flexible spending account; or

  • another payer

will reimburse a Sapyen service.

Unless Sapyen expressly accepts responsibility for obtaining reimbursement, you remain responsible for understanding your own coverage arrangements.

134. Digital content

Sapyen may provide:

  • reports;

  • ebooks;

  • handbooks;

  • educational resources;

  • videos;

  • analytical tools;

  • digital subscriptions; and

  • other digital content.

Digital-content cancellation rights may vary by jurisdiction.

Where applicable law permits immediate digital supply following specific consent or acknowledgement, Sapyen may seek that consent before providing immediate access.

135. Intellectual property

Sapyen and its licensors retain all applicable rights in:

  • Sapyen;

  • Sapyen trademarks;

  • SPX72 and related technologies;

  • SAGE;

  • SpermAge;

  • SpermRank;

  • scoring systems;

  • algorithms;

  • software;

  • websites;

  • applications;

  • patient reports and report design;

  • graphics;

  • educational content;

  • databases;

  • analytical methodologies;

  • product designs;

  • patents;

  • patent applications;

  • preservation technologies;

  • know-how;

  • trade secrets; and

  • other proprietary material.

136. Your report

You may use and share a report provided to you for legitimate personal purposes, including providing it to:

  • clinicians;

  • clinics;

  • partners;

  • family members;

  • insurers;

  • advisers; and

  • healthcare providers.

Receiving your report does not transfer ownership of Sapyen's underlying intellectual property.

137. Licence to digital services

Subject to these Terms, Sapyen gives you a limited, revocable, personal, non-exclusive and non-transferable right to use applicable consumer digital services for lawful personal purposes.

138. Prohibited use of Sapyen systems

Unless expressly authorised, you must not:

  • commercially reproduce Sapyen software;

  • systematically scrape Sapyen systems;

  • extract databases;

  • circumvent access controls;

  • reverse engineer proprietary systems where legally prohibited;

  • reproduce proprietary scoring systems;

  • resell portal access;

  • use non-public APIs without authorisation;

  • introduce malware;

  • conduct credential attacks;

  • interfere with system availability; or

  • use Sapyen systems to unlawfully build or train a competing commercial product.

Nothing in this section prohibits activity that applicable law expressly protects and does not permit Sapyen to restrict.

139. Feedback

If you voluntarily provide general suggestions, ideas or product feedback, Sapyen may use that feedback to improve its services without owing you compensation merely for receiving it.

This does not authorise Sapyen to publicly identify you or publish identifiable health information.

140. Privacy

Sapyen's handling of Personal Information and Health Information is described in the Sapyen Privacy Policy and applicable supplemental notices.

These Terms should be read with that Privacy Policy.

141. Research and development

Sapyen may conduct research, validation, analytics and product-development activities as described in its Privacy Policy and applicable research consents.

Where a particular activity requires additional consent, ethics approval or another authorisation, the applicable process will be followed.

142. De-identified and anonymous data

Subject to applicable law and the Privacy Policy, Sapyen may use properly de-identified, anonymous or aggregated information for purposes including:

  • research;

  • publication;

  • conferences;

  • benchmarking;

  • SAGE;

  • product development;

  • healthcare analytics;

  • assay development;

  • algorithm development;

  • artificial intelligence;

  • machine learning;

  • validation;

  • regulatory work;

  • commercial product development; and

  • other lawful purposes.

143. Research and intellectual-property outputs

Research and analysis may result in:

  • publications;

  • conference presentations;

  • discoveries;

  • patents;

  • assays;

  • diagnostic products;

  • software;

  • algorithms;

  • biomarkers;

  • statistical models;

  • reference populations;

  • commercial products; and

  • other intellectual property.

Unless separately agreed or required by law, contributing information to such work does not entitle an individual user to:

  • ownership;

  • royalties;

  • licensing revenue;

  • equity;

  • compensation; or

  • other financial participation in those outputs.

144. Website and digital-service availability

Sapyen aims to maintain reliable digital services but does not guarantee uninterrupted access.

Services may be unavailable because of:

  • maintenance;

  • security;

  • third-party outages;

  • upgrades;

  • system failures;

  • cyber incidents;

  • infrastructure issues; or

  • other events.

145. Digital updates

Sapyen may modify digital services to:

  • improve functionality;

  • improve security;

  • add features;

  • remove obsolete features;

  • satisfy regulatory requirements;

  • update analytical systems; or

  • improve user experience.

Sapyen will not intentionally remove a material prepaid entitlement without providing an appropriate remedy where required by law.

146. Acceptable use

You must not use Sapyen to:

  • break the law;

  • commit fraud;

  • impersonate another person;

  • submit an unauthorised specimen;

  • compromise security;

  • access another person's records without authority;

  • interfere with Sapyen systems;

  • harass staff;

  • threaten healthcare professionals;

  • introduce malicious software;

  • engage in abusive automated access; or

  • materially interfere with another user's services.

147. Fraud and misuse

Sapyen may investigate suspected:

  • payment fraud;

  • identity fraud;

  • specimen substitution;

  • false delivery claims;

  • fabricated missing-component claims;

  • promotional abuse;

  • account misuse;

  • unauthorised access;

  • chargeback abuse; or

  • other dishonest conduct.

148. Abusive conduct

Sapyen may take reasonable measures to protect:

  • staff;

  • clinicians;

  • laboratory personnel;

  • partners; and

  • other users

from threats, harassment, discriminatory abuse, stalking or other serious misconduct.

Measures may include restricting non-essential communication channels while preserving access to information or services that Sapyen is legally required to provide.

149. Suspension

Sapyen may suspend some or all non-essential access where reasonably necessary because of:

  • security concerns;

  • fraud;

  • material breach;

  • unlawful use;

  • regulatory requirements;

  • patient-safety concerns;

  • abusive conduct; or

  • system integrity.

150. Termination

Sapyen may terminate future access for:

  • serious breach;

  • repeated misuse;

  • fraud;

  • safety concerns;

  • illegality;

  • service discontinuation;

  • geographic restrictions; or

  • another legitimate reason.

Termination does not remove rights or obligations that accrued beforehand.

151. Stopping use does not automatically cancel other arrangements

Closing an account or stopping use of Sapyen does not automatically:

  • cancel a subscription;

  • cancel cryogenic storage;

  • cancel a pending test;

  • withdraw a consent;

  • require deletion of records that must be retained; or

  • reverse a completed transaction.

You must use the applicable process for the action you intend to take.

152. Service providers

Sapyen may engage third parties for functions including:

  • laboratories;

  • fulfilment;

  • manufacturing;

  • logistics;

  • courier services;

  • cloud hosting;

  • telecommunications;

  • software;

  • cybersecurity;

  • customer support;

  • clinical services;

  • telehealth;

  • payment processing;

  • cryopreservation;

  • storage;

  • regulatory work; and

  • professional services.

Sapyen may change these service providers without your consent where the change does not materially deprive you of the service purchased.

153. Third-party websites and services

Sapyen services may link to or integrate with external organisations.

Those organisations may apply their own:

  • terms;

  • privacy policies;

  • clinical terms;

  • payment rules; and

  • operational requirements.

A link or integration does not necessarily mean Sapyen controls the independent organisation.

154. No guarantee of particular third-party availability

Sapyen does not guarantee that a specific:

  • courier;

  • laboratory;

  • clinician;

  • clinic;

  • genetic testing provider;

  • storage provider; or

  • technology provider

will remain available indefinitely.

Sapyen may substitute an appropriate provider.

155. Mandatory consumer protections

Nothing in these Terms excludes, restricts or modifies:

  • statutory consumer guarantees;

  • mandatory warranties;

  • cancellation rights;

  • withdrawal rights;

  • refund rights;

  • healthcare rights;

  • remedies for defective products;

  • remedies for improperly performed services; or

  • another right

that applicable law does not permit Sapyen to exclude, restrict or modify.

156. No guarantee of particular outcomes

Subject to mandatory law, Sapyen does not promise that:

  • every specimen will be testable;

  • every assay will produce a result;

  • a result will be normal;

  • an abnormal result will be clinically actionable;

  • a specific laboratory will be used;

  • a particular clinician will be available;

  • a treatment will be recommended;

  • pregnancy will occur;

  • fertility treatment will succeed;

  • a frozen specimen will survive thawing;

  • SAGE will predict a future reproductive outcome; or

  • a particular service will remain unchanged indefinitely.

157. Losses not caused by Sapyen

Sapyen is not responsible for losses that were not caused by Sapyen or another person or organisation for whose conduct Sapyen is legally responsible.

158. Independent clinical decisions

An independent clinician remains responsible for their professional judgment.

Sapyen is not responsible for an independent clinician's negligence merely because Sapyen facilitated access to the clinician, except where applicable law imposes responsibility on Sapyen.

159. Independent laboratory conduct

Independent laboratories remain responsible for obligations imposed directly on them by applicable laboratory, professional and healthcare law.

Sapyen remains responsible to the extent applicable law or Sapyen's own contractual obligations make Sapyen responsible.

160. Consequential loss

To the maximum extent permitted by applicable law, Sapyen is not liable for indirect or consequential loss that was not a reasonably foreseeable consequence of a breach for which Sapyen is legally responsible.

Different limitations may apply under applicable consumer law.

161. Business losses

Where you purchase Sapyen solely as a consumer, Sapyen is not responsible for purely business losses such as:

  • lost profits;

  • lost commercial opportunity; or

  • business interruption

except where applicable law requires otherwise.

162. Matters that cannot be excluded

Nothing in these Terms excludes or limits liability to the extent exclusion or limitation is prohibited by law.

Depending on the applicable jurisdiction, this may include liability relating to:

  • death or personal injury caused by negligence;

  • fraud;

  • fraudulent misrepresentation;

  • wilful misconduct;

  • certain statutory consumer guarantees; or

  • another non-excludable liability.

163. United States liability limitation

For United States consumer services, to the maximum extent permitted by applicable law, Sapyen's aggregate liability arising from the particular consumer service giving rise to a claim will not exceed the greater of:

  1. the amount paid by you to Sapyen for the product or service giving rise to the claim during the preceding twelve months; or

  2. US$500.

This limitation does not apply where applicable law prohibits it.

164. United States consequential damages

To the maximum extent permitted by applicable United States law, Sapyen is not liable for:

  • punitive;

  • exemplary;

  • incidental;

  • special;

  • indirect; or

  • consequential

damages arising from consumer use of Sapyen services where those damages may lawfully be excluded.

165. User responsibility for intentional misuse

To the extent permitted by law, you are responsible for losses reasonably caused by your intentional:

  • fraud;

  • cyberattack;

  • unauthorised specimen submission;

  • malicious misuse;

  • unlawful disclosure of another person's health information; or

  • infringement of Sapyen intellectual property.

You are not required to indemnify Sapyen for Sapyen's own negligence or wrongdoing where such an indemnity would be prohibited or unfair under applicable law.

166. Force majeure and matters outside reasonable control

Sapyen is not in breach merely because performance is delayed or prevented by an event outside its reasonable control.

Such events may include:

  • severe weather;

  • natural disaster;

  • war;

  • civil disorder;

  • epidemic;

  • pandemic;

  • government restriction;

  • border closure;

  • carrier interruption;

  • laboratory shutdown;

  • infrastructure failure;

  • cyberattack despite reasonable precautions;

  • industrial action;

  • supply interruption;

  • power outage; or

  • another comparable event.

167. Response to external disruption

Where an external event affects a service, Sapyen may:

  • delay performance;

  • change courier;

  • change laboratory;

  • change return label;

  • reroute specimens;

  • change fulfilment provider;

  • substitute service providers;

  • modify operational processes;

  • offer recollection;

  • offer another reasonable solution; or

  • cancel an affected service.

Mandatory refund or cancellation rights remain unaffected.

168. Electronic communications

Where legally permitted, Sapyen may communicate with you electronically through:

  • email;

  • SMS;

  • patient portals;

  • account notifications;

  • app notifications;

  • electronic forms; or

  • other digital communication.

169. Operational communications

Operational communications may include:

  • order confirmations;

  • activation reminders;

  • revised return labels;

  • routing changes;

  • specimen-return instructions;

  • laboratory updates;

  • corrected reports;

  • result notifications;

  • appointment information;

  • payment notices;

  • subscription notices;

  • storage notices;

  • safety communications; and

  • service changes.

You may not be able to opt out of communications reasonably necessary to provide an active service.

170. Contact information

You are responsible for maintaining reasonably current contact information where this is necessary for us to provide the service.

Sapyen is not responsible for a failure to receive an important operational notice solely because you provided materially incorrect contact information or failed to update it.

171. Changes to these Terms

Sapyen may update these Terms in response to:

  • legal changes;

  • regulatory changes;

  • new products;

  • new laboratories;

  • new technologies;

  • operational changes;

  • changes in payment models;

  • security requirements;

  • new markets;

  • changed healthcare practices; or

  • clarification of existing provisions.

172. Material changes to ongoing services

Where a material change affects an existing ongoing service, Sapyen will provide notice or obtain renewed agreement where required by applicable law.

Sapyen will not rely on a later amendment to retroactively remove a mandatory right that has already accrued.

173. Assignment

Sapyen may assign or transfer its rights and obligations under these Terms to:

  • an affiliate;

  • successor;

  • purchaser;

  • acquiring company; or

  • another entity as part of a legitimate corporate transaction,

provided that the transfer does not unlawfully reduce your rights.

174. No waiver

Failure by Sapyen to enforce a provision on one occasion does not necessarily waive the right to enforce it later.

175. Severability

If a provision is held invalid or unenforceable, the remaining Terms continue to apply to the fullest extent permitted by law.

An invalid provision should be modified only to the minimum extent necessary to make it lawful where the applicable legal system permits such modification.

176. Entire agreement

These Terms, together with applicable:

  • service-specific terms;

  • consents;

  • payment disclosures;

  • order information;

  • storage agreements; and

  • incorporated policies

form the agreement governing the relevant Sapyen service.

Nothing in this clause excludes representations or rights that applicable consumer law makes binding.

177. Interpretation

The words “include” and “including” mean including without limitation unless the context clearly requires otherwise.

References to a law include amendments or replacement legislation where appropriate.

Headings are for convenience and do not independently alter meaning.

178. Survival

Provisions that by their nature should continue after termination survive as appropriate, including provisions concerning:

  • payment;

  • records;

  • intellectual property;

  • research outputs;

  • stored material;

  • completed services;

  • liability;

  • disputes; and

  • accrued rights.

179. Complaints

If you believe a Sapyen service has not been properly provided, please contact Sapyen with enough information for us to investigate.

Complaints may concern:

  • kits;

  • fulfilment;

  • specimen transport;

  • laboratories;

  • results;

  • billing;

  • subscriptions;

  • cryopreservation;

  • telehealth;

  • customer support;

  • privacy; or

  • another service.

180. Regulatory complaints

Nothing in these Terms prevents you from contacting an applicable:

  • consumer regulator;

  • privacy regulator;

  • medical regulator;

  • laboratory regulator;

  • medical-device authority;

  • professional board;

  • court;

  • tribunal; or

  • government authority.

181. Informal dispute resolution

Before commencing formal proceedings, we encourage you to contact Sapyen and provide:

  • your identity;

  • relevant order information;

  • the nature of the dispute;

  • relevant facts; and

  • the resolution you seek.

This does not prevent you from:

  • seeking urgent relief;

  • protecting a limitation period;

  • exercising a statutory right; or

  • contacting a regulator.

182. Governing law generally

The applicable governing law depends on:

  • where you live;

  • the Sapyen entity supplying the service;

  • mandatory consumer protections;

  • the service; and

  • any applicable service-specific agreement.

A governing-law clause does not deprive a consumer of mandatory protections that applicable law does not permit them to waive.

183. AUSTRALIA

Where Australian consumer law applies, the following provisions also apply.

183.1 Australian Consumer Law

Nothing in these Terms excludes, restricts or modifies a consumer guarantee, right or remedy under the Australian Consumer Law that cannot lawfully be excluded, restricted or modified.

183.2 Change of mind

Except where Sapyen expressly offers a change-of-mind policy, Australian consumers are not given a contractual refund entitlement merely because they change their mind after the applicable Sapyen cancellation period.

Mandatory rights concerning faulty goods or deficient services remain unaffected.

183.3 Reasonable time

Where applicable law requires a service to be performed within a reasonable time, nothing in the general delay provisions removes that requirement.

A stated estimated turnaround is nevertheless not a guaranteed deadline unless expressly stated otherwise.

183.4 Remedies

Where Australian Consumer Law gives a consumer a particular right to choose a remedy, that statutory right prevails over any clause giving Sapyen discretion to select a remedy.

183.5 Governing law

Subject to applicable mandatory rights, Australian contracts are governed by the laws of Victoria, Australia.

184. UNITED KINGDOM

Where UK consumer law applies, the following provisions also apply.

184.1 Mandatory rights

Nothing in these Terms excludes or restricts UK consumer protections that cannot lawfully be excluded.

184.2 Distance purchases

Where the law provides a cancellation period for an eligible distance contract, Sapyen will honour that cancellation period.

184.3 Fourteen-day period

Where applicable, an eligible UK consumer has a 14-calendar-day statutory cancellation period calculated according to applicable law.

184.4 Health and hygiene exception

Where applicable law provides that cancellation rights are lost for qualifying sealed goods that:

  • are unsuitable for return for genuine health or hygiene reasons; and

  • are unsealed after delivery,

Sapyen may rely on that exception.

184.5 Services commenced during cancellation period

If you expressly ask Sapyen to begin an eligible service before the statutory cancellation period expires, consequences permitted by applicable law may apply, including payment for services already supplied.

184.6 Cryopreservation

The UK cryopreservation cancellation provisions in these Terms are subject to any applicable 14-day statutory cancellation right.

184.7 Governing law

A UK consumer retains all mandatory protections of applicable UK law and may bring proceedings in a court available under applicable jurisdictional rules.

185. EUROPEAN ECONOMIC AREA

Where EEA consumer law applies, the following provisions also apply.

185.1 Mandatory EU and national rights

These Terms do not remove mandatory rights arising under applicable EU or national consumer law.

185.2 Distance contracts

Where applicable, eligible consumers have statutory withdrawal rights for distance contracts.

185.3 Fourteen-day withdrawal

Where required by applicable law, Sapyen will provide the applicable 14-calendar-day withdrawal period.

185.4 Exceptions

Applicable statutory exceptions may include qualifying:

  • opened sealed health or hygiene goods;

  • fully performed services where legal requirements are met;

  • digital content;

  • personalised products; or

  • other legally exempt services.

185.5 Local laws

National consumer laws may provide additional protections.

Those protections prevail where they cannot be waived.

186. CANADA

Where Canadian consumer law applies:

  • mandatory federal, provincial and territorial consumer protections remain unaffected;

  • refund, cancellation, automatic-renewal and contract requirements may vary by province;

  • any mandatory cooling-off period longer than a Sapyen contractual period prevails; and

  • any restriction on arbitration, forum selection, liability limitations or automatic renewal under applicable provincial law prevails.

For Quebec consumers, mandatory Quebec consumer protections apply where applicable.

187. UNITED STATES

The following additional provisions apply to users in the United States to the extent permitted by law.

187.1 State laws

Mandatory consumer, health, genetic, telehealth and laboratory rights under applicable state law remain unaffected.

187.2 Contractual cryopreservation cancellation period

Except where longer rights are required by applicable law or expressly provided for a particular transaction, Sapyen's contractual cryopreservation cancellation period for US consumers is 7 calendar days from purchase.

Once that period expires, applicable deferred cryopreservation charges may be collected and no discretionary change-of-mind refund will ordinarily be provided.

188. UNITED STATES ARBITRATION AGREEMENT

PLEASE READ THIS SECTION CAREFULLY.

Except where prohibited by law or specifically excluded below, you and Sapyen agree that covered disputes will be resolved through binding individual arbitration rather than through a jury trial.

189. Agreement to arbitrate

Except for excluded disputes, you and Sapyen agree to individually arbitrate claims arising out of or relating to:

  • these Terms;

  • your Sapyen account;

  • a Sapyen purchase;

  • a Sapyen diagnostic service;

  • SAGE;

  • cryopreservation;

  • subscriptions;

  • communications with Sapyen; or

  • another Sapyen consumer service

where the claim is legally subject to predispute arbitration.

190. Individual arbitration

Unless both sides agree otherwise or applicable law requires a different result, arbitration will proceed on an individual basis.

191. Class-action waiver

To the fullest extent permitted by applicable law, you and Sapyen waive participation in class, collective or representative proceedings concerning disputes covered by the arbitration agreement.

192. Jury waiver

For disputes validly subject to arbitration, you and Sapyen waive the right to have the dispute decided by a jury.

193. Excluded disputes

Arbitration does not prevent:

  • an eligible small-claims action;

  • complaints to regulators;

  • claims that applicable law does not permit to be subjected to predispute arbitration;

  • appropriate urgent injunctive relief relating to system security or intellectual property; or

  • another legally excluded claim.

194. Informal dispute notice

Before filing arbitration, the claimant should provide written notice identifying:

  • the claimant;

  • relevant order or account information;

  • the material facts;

  • the legal or contractual issue; and

  • the relief requested.

The parties will attempt good-faith informal resolution before arbitration, except where urgent action or a legal deadline requires otherwise.

195. Arbitration administrator

Unless otherwise agreed, eligible US consumer arbitration may be administered by the American Arbitration Association under the applicable consumer rules in effect when the claim is filed.

196. Arbitration costs

Costs will be allocated according to:

  • applicable law;

  • applicable consumer arbitration rules; and

  • any obligation Sapyen must satisfy for the agreement to remain enforceable.

197. Arbitration opt-out

A US consumer may opt out of this arbitration agreement by providing written notice to Sapyen within 30 days after first accepting the version of these Terms containing the arbitration agreement.

The notice must:

  • clearly state that you are opting out of arbitration; and

  • contain enough information for Sapyen to identify the applicable account or transaction.

Opting out does not affect your ability to use ordinary Sapyen consumer services.

198. US governing law

Except for matters governed by the Federal Arbitration Act and mandatory state law, contracts with Sapyen, Inc. are governed by Delaware law without regard to conflict-of-law principles.

Mandatory protections of your state remain applicable where they cannot lawfully be waived.

199. OTHER COUNTRIES

Where Sapyen operates in another jurisdiction not expressly addressed above:

  • mandatory consumer law applies;

  • mandatory healthcare law applies;

  • applicable diagnostic and laboratory requirements apply;

  • any legally required cancellation right applies; and

  • these Terms are modified only to the extent necessary to comply with non-waivable local law.

200. Language versions

Sapyen may provide translated versions of these Terms.

Where applicable law requires a particular language version to govern, that requirement applies.

Otherwise, to the extent legally permitted, the English version controls ambiguities between translations.

201. Contact

Questions regarding these Terms may be directed through the contact information published by Sapyen.

Sapyen

Level 22, 120 Spencer Street
Melbourne VIC 3000
Australia

Email: compliance@sapyen.co
Website: sapyen.co

Privacy matters should be handled through the process described in the current Sapyen Privacy Policy.

202. Final provision

These Terms are intended to provide Sapyen with the operational flexibility necessary to deliver diagnostic and healthcare services across changing laboratory, logistics, technology and clinical environments while preserving rights that applicable law requires.

Where these Terms give Sapyen a right, discretion or choice, that right will be exercised subject to:

  • applicable law;

  • mandatory consumer protections;

  • applicable healthcare requirements;

  • applicable regulatory obligations;

  • service-specific agreements; and

  • good-faith contractual obligations.

Effective Date: 19 August 2026

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