Terms

Version: 1.0

Effective date: 16 September 2026

These Terms of Service (the “Terms”) govern access to and use of the Blue Peak platform and the services supplied by Blue Peak Consulting Group Ltd, a company incorporated in England and Wales with registered office at 7a Eastgate Street, Winchester, England, SO23 8EB (“Blue Peak”, “we”, “us” or “our”).

These Terms apply between Blue Peak and the business or other legal entity identified when creating an account, accepting an Order or purchasing Services (“Customer”, “you” or “your”).

These Terms are intended for business customers only and not consumers.

By creating an account, accepting an Order, purchasing Services or otherwise agreeing to these Terms, you confirm that:

(a) you are acting for business purposes;

(b) you have authority to bind the Customer; and

(c) the Customer agrees to these Terms.

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1. Contract structure

1.1

These Terms form the master agreement governing the commercial relationship between Blue Peak and the Customer.

1.2

Depending on the Services purchased, the agreement between Blue Peak and the Customer may also include:

(a) any Regulatory Services Terms applicable to the Services;

(b) the applicable Service Order or other order document accepted by the Customer; and

(c) any additional terms expressly incorporated into that Service Order.

Together, these documents form the “Agreement”.

1.3

Where the Services involve a regulatory provider, responsible person, authorised representative, sponsor, agent or other regulatory appointment, the identity of the applicable provider or representative will be identified in the relevant Service Order or Regulatory Appointment.

1.4

Where a separate appointment, mandate or other regulatory instrument is required between the manufacturer and a regulatory provider or statutory representative, that instrument creates a separate legal relationship and does not replace the Customer's commercial agreement with Blue Peak.

This reflects the agreed architecture: the Customer purchases the managed service from Blue Peak, while a statutory appointment can exist separately between the manufacturer and the actual representative.

1.5 Order of precedence

If there is a conflict between documents forming the Agreement, the following order of precedence applies in relation to that conflict:

1. the Service Order;

2. the Regulatory Services Terms, where applicable;

3. these Terms; and

4. any other document expressly incorporated into the Agreement,

unless the relevant document expressly states otherwise.

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2. Blue Peak Services

2.1

Blue Peak provides a technology-enabled managed service designed to support businesses with international product regulatory compliance and related services.

Depending on the Service Order, the Services may include:

(a) access to the Blue Peak platform;

(b) onboarding and product information management;

(c) collection and management of regulatory documentation;

(d) management of regulatory review workflows;

(e) communication of regulatory findings and required actions;

(f) coordination and management of regulatory providers and specialists;

(g) management of regulatory representation services;

(h) ongoing compliance and change-management workflows; and

(i) customer support and related services specified in the Service Order.

2.2

The precise Services purchased by the Customer, including applicable markets, products, product families, regulatory roles, regulatory providers, term and fees, are set out in the relevant Service Order.

2.3

Blue Peak may use appropriately qualified third-party providers, specialists, laboratories, professional advisers, technology providers and subcontractors in delivering the Services.

Where a third party performs a material regulatory function or is proposed to hold a statutory regulatory appointment, that party will be identified to the Customer as required by the applicable Service Order and Regulatory Services Terms.

2.4

Unless expressly stated in a Service Order, the Services do not include legal advice, tax advice, customs brokerage, logistics services, product manufacturing, laboratory testing or other specialist services outside the agreed scope.

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3. Regulatory Services

3.1

Where the Customer purchases regulatory compliance, regulatory representation or related Services, the Blue Peak Regulatory Services Terms also apply.

3.2

Those terms govern matters including:

(a) regulatory review;

(b) regulatory providers;

(c) statutory appointments;

(d) regulatory findings and acceptance;

(e) product and manufacturer responsibilities;

(f) remediation;

(g) material product changes;

(h) incidents and authority communications;

(i) regulatory suspension and withdrawal; and

(j) use of regulatory representative details.

3.3

Payment for a Service does not, by itself, constitute regulatory approval, confirmation of compliance or activation of a statutory regulatory appointment.

Where an appointment is required, its status and effective date are determined in accordance with the Regulatory Services Terms, Service Order and applicable Regulatory Appointment.

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4. Customer Account

4.1

The Customer may be required to create an account to access the Blue Peak platform.

4.2

The Customer must:

(a) provide accurate account information;

(b) keep its account information reasonably current;

(c) ensure that account credentials are kept secure;

(d) restrict account access to authorised personnel; and

(e) notify Blue Peak promptly if it becomes aware of unauthorised access or a security compromise.

4.3

The Customer is responsible for activity carried out through its account by persons it has authorised to use the platform.

4.4

The Customer must ensure that each person using the platform on its behalf complies with the Agreement.

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5. Customer Information and Cooperation

5.1

The Customer must provide information, documents, evidence and assistance reasonably required for Blue Peak to perform the Services.

5.2

The Customer warrants that information supplied by or on behalf of it is, to the best of its knowledge:

(a) accurate;

(b) complete in all material respects;

(c) not misleading; and

(d) supplied lawfully.

5.3

Blue Peak and any applicable regulatory provider may rely on information supplied by the Customer, manufacturer or their authorised representatives unless there is a reasonable basis to question it.

5.4

The Customer must promptly notify Blue Peak if it discovers that material information previously supplied was inaccurate, incomplete or has changed.

5.5

Blue Peak is not responsible for delay or failure caused by the Customer's failure to provide information, documents, decisions, access or cooperation reasonably required to perform the Services.

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6. Platform Use

6.1

Subject to the Agreement and payment of applicable fees, Blue Peak grants the Customer a limited, non-exclusive, non-transferable and revocable right during the applicable Service term to access and use the platform for its internal business purposes in connection with the Services.

6.2

The Customer must not:

(a) use the platform unlawfully or fraudulently;

(b) attempt to gain unauthorised access to the platform or associated systems;

(c) interfere with the security, integrity or operation of the platform;

(d) introduce malicious code;

(e) copy, reproduce, sell, sublicense or commercially exploit the platform except as expressly permitted;

(f) reverse engineer, decompile or attempt to derive the source code of the platform except to the extent such restriction is prohibited by law;

(g) use automated means to access the platform in a manner that materially interferes with its operation; or

(h) use the platform or Services to infringe the rights of another person.

6.3

Blue Peak may suspend access where reasonably necessary to:

(a) protect the security or integrity of the platform;

(b) investigate suspected misuse;

(c) perform maintenance;

(d) comply with law; or

(e) address a material breach of the Agreement.

Where reasonably practicable, Blue Peak will give advance notice.

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7. Platform Availability and Changes

7.1

Blue Peak will use reasonable care and skill in providing the platform and Services.

7.2

The platform may occasionally be unavailable due to maintenance, updates, technical failures or circumstances outside Blue Peak's reasonable control.

7.3

Blue Peak may modify or improve the platform from time to time, including its interface, functionality, workflows and underlying technology.

7.4

Blue Peak will not materially reduce the core functionality of a paid Service during its current term in a manner that materially prevents the Customer from receiving that Service, except where reasonably necessary for legal, regulatory, security or technical reasons.

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8. Fees and Payment

8.1

The Customer must pay the fees specified in the applicable Service Order.

8.2

Unless stated otherwise, fees exclude VAT and any other applicable sales, use or similar taxes.

8.3

The Customer authorises Blue Peak and its payment provider to charge the agreed payment method in accordance with the billing arrangement selected by the Customer.

8.4 Annual payment

Where annual payment is selected, the applicable annual fee is payable in accordance with the Service Order.

8.5 Monthly instalments

Where monthly billing is selected, the Customer is purchasing a 12-month Service term paid in 12 monthly instalments.

Monthly billing does not create a month-to-month contract or a right to cancel the remaining financial commitment after each monthly payment.

8.6

Except where the Agreement expressly provides otherwise or required by law, fees paid are non-refundable.

8.7

The Customer must maintain a valid payment method for recurring payments.

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9. Late and Failed Payments

9.1

If payment is overdue or fails, Blue Peak may notify the Customer and require payment within a reasonable cure period.

9.2

If payment remains outstanding, Blue Peak may suspend or restrict commercial or platform Services where appropriate.

9.3

Where the Customer has an active statutory regulatory appointment, payment failure does not automatically terminate that appointment.

Any suspension, withdrawal or termination of a regulatory appointment will instead be managed in accordance with the applicable Regulatory Services Terms, Regulatory Appointment and legal or regulatory requirements.

9.4

The Customer remains responsible for amounts properly due under the Agreement notwithstanding suspension for non-payment.

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10. Term and Renewal

10.1

Unless the Service Order states otherwise, each paid managed Service has an initial term of 12 months.

10.2

The Service will renew for a further term of the same length unless either party gives notice of non-renewal in accordance with the Agreement or the Service Order.

10.3

Blue Peak may send renewal reminders before the renewal date.

10.4

The Customer may manage its renewal preference through its account where that functionality is available.

10.5

Choosing not to renew prevents the next Service term from commencing. It does not retrospectively cancel the current Service term or remove amounts already payable.

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11. Intellectual Property

11.1 Blue Peak Materials

Blue Peak and its licensors retain all intellectual property rights in:

(a) the Blue Peak platform;

(b) software, source code and system architecture;

(c) workflows and platform functionality;

(d) templates, methodologies and frameworks;

(e) branding; and

(f) materials developed independently of Customer-specific work,

together the “Blue Peak Materials”.

11.2 Customer Materials

The Customer retains ownership of materials, documents, data, trademarks and other intellectual property supplied by it to Blue Peak (“Customer Materials”).

11.3

The Customer grants Blue Peak a non-exclusive licence to use, host, reproduce, process and share Customer Materials to the extent reasonably necessary to:

(a) provide the Services;

(b) operate the platform;

(c) work with identified regulatory providers and authorised subcontractors;

(d) comply with legal or regulatory requirements; and

(e) exercise Blue Peak's rights under the Agreement.

11.4

The Customer warrants that it has the rights necessary to provide the Customer Materials and permit their use in accordance with the Agreement.

11.5 Deliverables

Unless otherwise specified in the Service Order, once all applicable fees for a deliverable have been paid, the Customer may use Customer-specific reports, assessments and other deliverables supplied to it for its internal business and regulatory purposes.

Blue Peak retains ownership of underlying methodologies, templates, know-how, software and other Blue Peak Materials incorporated into them.

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12. Confidentiality

12.1

Each party must keep confidential any non-public commercial, financial, technical, regulatory or other confidential information received from the other in connection with the Agreement (“Confidential Information”).

12.2

A party may use Confidential Information only to perform or receive the Services, exercise its rights under the Agreement or comply with legal or regulatory obligations.

12.3

Confidential Information may be disclosed to employees, affiliates, professional advisers, contractors, regulatory providers and other persons who reasonably need it for those purposes and are subject to appropriate confidentiality obligations.

12.4

These obligations do not apply to information that:

(a) is lawfully public other than through breach of the Agreement;

(b) was already lawfully known to the receiving party;

(c) is lawfully received from another person without confidentiality restriction; or

(d) is independently developed without use of the Confidential Information.

12.5

A party may disclose Confidential Information where required by law, court order or regulatory authority.

12.6

The confidentiality obligations continue for five years after termination, except for information constituting a trade secret or information which applicable law requires to remain protected for longer.

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13. Data Protection

13.1

Each party must comply with applicable data protection law in relation to personal data processed under the Agreement.

13.2

Blue Peak processes personal data in accordance with its Privacy Policy, as updated from time to time in accordance with applicable law.

13.3

Where the nature of a Service requires additional data-processing terms, the parties will enter into those terms as reasonably required.

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14. Technology and Artificial Intelligence

14.1

Blue Peak may use automation, machine learning and artificial intelligence systems in connection with the platform and Services, including to assist with:

(a) information extraction;

(b) document classification;

(c) product classification;

(d) preliminary analysis;

(e) identification and preparation of potential findings;

(f) workflow management; and

(g) preparation of draft regulatory work.

14.2

The use of such technology does not change the allocation of responsibility under the Agreement.

14.3

Where the Service requires a material regulatory acceptance, rejection or statutory appointment decision, such decision will not be made solely by an automated AI system.

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15. Third-Party Services

15.1

The Services may interact with or depend upon third-party platforms, payment providers, marketplaces, laboratories, specialists, regulatory providers or other third-party services.

15.2

Blue Peak is not responsible for the availability or operation of independent third-party platforms or services that are outside Blue Peak's reasonable control.

15.3

This clause does not exclude Blue Peak's responsibility for its own acts or omissions or any responsibility expressly accepted by Blue Peak under the Agreement.

15.4

Responsibility for services performed by an identified regulatory provider is addressed in the Regulatory Services Terms and applicable Service Order.

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16. Warranties and Nature of the Services

16.1

Blue Peak warrants that it will perform the Services it is responsible for with reasonable care and skill.

16.2

Except as expressly stated in the Agreement and to the maximum extent permitted by law, no other warranty, representation or condition is given regarding the Services.

16.3

Blue Peak does not warrant that:

(a) the platform will be uninterrupted or error-free at all times;

(b) use of the Services will guarantee regulatory approval or market access;

(c) a marketplace, authority or other third party will accept a product, submission or document; or

(d) laws, regulatory interpretations or third-party requirements will remain unchanged.

16.4

Nothing in the Agreement limits any statutory duty imposed directly upon a regulatory provider or statutory representative.

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17. Limitation of Liability

17.1

Nothing in the Agreement excludes or limits liability where doing so would be unlawful, including liability for:

(a) death or personal injury caused by negligence;

(b) fraud or fraudulent misrepresentation; or

(c) any other liability that cannot lawfully be excluded or limited.

17.2

Subject to clause 17.1, neither party will be liable to the other for any:

(a) indirect or consequential loss;

(b) loss of profit;

(c) loss of revenue;

(d) loss of anticipated savings;

(e) loss of business opportunity; or

(f) loss of goodwill,

except to the extent such loss is expressly recoverable under another provision of the Agreement.

17.3

Subject to clause 17.1, Blue Peak is not responsible for losses arising to the extent caused by:

(a) inaccurate, incomplete or misleading information supplied by the Customer, manufacturer or another person acting on their behalf;

(b) undisclosed product or business changes;

(c) failure to implement required or agreed corrective actions;

(d) use of Services, reports or regulatory details outside their agreed scope;

(e) Customer Materials;

(f) product defects, manufacturing failures or product-safety issues for which Blue Peak is not responsible; or

(g) acts or omissions of the Customer or manufacturer.

17.4

Blue Peak will not be liable for regulatory opinions, assessments, decisions, statutory representation or other professional regulatory services performed by an identified independent regulatory provider, except to the extent that the relevant loss was caused or contributed to by Blue Peak's own breach, negligence or other act or omission for which Blue Peak is legally responsible.

17.5

Subject to clause 17.1, Blue Peak's total aggregate liability arising out of or in connection with the Agreement in any 12-month period will not exceed the total fees paid or payable by the Customer to Blue Peak under the affected Service during the 12 months preceding the event giving rise to the claim.

17.6

The limitations in this clause apply whether liability arises in contract, tort (including negligence), misrepresentation, restitution, breach of statutory duty or otherwise.

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18. Indemnity

18.1

The Customer will indemnify Blue Peak against third-party claims, losses, liabilities and reasonable costs arising from:

(a) infringement caused by Customer Materials;

(b) the Customer's unlawful use of the platform or Services;

(c) unauthorised use of a regulatory provider's name, address or appointment details; or

(d) a material breach by the Customer of its obligations concerning information, products or regulatory use,

except to the extent caused or contributed to by Blue Peak's breach, negligence or other wrongful act.

18.2

Nothing in this clause requires the Customer to indemnify Blue Peak for liability which applicable law imposes directly upon Blue Peak and which cannot lawfully be transferred.

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19. Suspension

19.1

Blue Peak may suspend affected Services where reasonably necessary because:

(a) the Customer materially breaches the Agreement;

(b) payment remains overdue following notice and a reasonable opportunity to cure;

(c) the Customer's use presents a material security risk;

(d) continued provision would be unlawful; or

(e) suspension is otherwise expressly permitted under the Regulatory Services Terms.

19.2

Suspension of Blue Peak platform or commercial Services does not automatically terminate or suspend a statutory regulatory appointment.

Any such action must follow the applicable regulatory process.

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20. Termination

20.1

Either party may terminate the Agreement or an affected Service where the other party commits a material breach which is incapable of remedy or, where capable of remedy, is not remedied within 30 days after written notice.

20.2

Either party may terminate immediately if the other:

(a) becomes insolvent;

(b) enters liquidation other than for a solvent restructuring;

(c) has an administrator or similar insolvency officer appointed; or

(d) ceases substantially all of its business.

20.3

Termination or expiry does not affect rights and liabilities accrued before termination.

20.4

Clauses intended by their nature to survive termination will continue, including provisions concerning payment obligations, intellectual property, confidentiality, liability and dispute resolution.

20.5

Where an active regulatory appointment exists, expiry or termination of the Blue Peak commercial relationship will trigger the applicable regulatory offboarding process rather than automatically extinguishing that appointment.

That may include transfer or retention of records, successor arrangements, changes to labels or online information, authority notifications or formal termination of the appointment as applicable.

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21. Communications and Notices

21.1

Blue Peak may communicate operational matters through the platform, account notifications or the email address associated with the Customer's account.

21.2

Formal legal notices under the Agreement must be sent by email to:

Blue Peak: info@bluepeakconsulting.co.uk

and, for the Customer, to the notice email specified in its account or Service Order.

21.3

A party must keep its notice details current.

21.4

Nothing in this clause restricts urgent regulatory or safety communications required under the Regulatory Services Terms.

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22. Electronic Contracting

22.1

The parties agree that the Agreement may be formed, accepted and signed electronically.

22.2

Acceptance through the Blue Peak platform, including through an electronic checkbox, electronic signature or other electronic acceptance mechanism presented by Blue Peak, is intended to evidence the Customer's agreement to the applicable contractual documents.

22.3

Blue Peak may retain electronic records including:

(a) the identity and account of the accepting user;

(b) Customer legal entity;

(c) acceptance date and time;

(d) relevant Service Order;

(e) versions of contractual documents accepted; and

(f) other technical evidence reasonably maintained to record the transaction.

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23. Changes to these Terms

23.1

Blue Peak may update these Terms from time to time.

23.2

Changes required by law, regulation, security requirements or changes that do not materially disadvantage the Customer may take effect on reasonable notice.

23.3

A material change affecting an existing paid Service will not retrospectively alter the parties' accrued rights or materially reduce the Customer's contracted Service during its current term unless:

(a) required by law or regulation;

(b) agreed with the Customer; or

(c) expressly permitted by the Agreement.

23.4

The version accepted by the Customer will be retained as part of Blue Peak's contractual records.

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24. General

24.1 Assignment

The Customer may not assign or transfer the Agreement without Blue Peak's prior written consent, not to be unreasonably withheld.

Blue Peak may assign the Agreement to an affiliate or in connection with a merger, restructuring, sale of substantially all relevant assets or transfer of the relevant business, provided this does not materially reduce the Customer's rights.

24.2 Subcontracting

Blue Peak may subcontract elements of the Services but remains responsible for obligations expressly allocated to Blue Peak under the Agreement.

This does not make Blue Peak responsible for statutory or professional functions expressly allocated to an independently identified regulatory provider under the Regulatory Services Terms.

24.3 Force majeure

Neither party is liable for failure or delay caused by circumstances beyond its reasonable control, provided it takes reasonable steps to mitigate the effect.

This clause does not excuse payment obligations already due.

24.4 No partnership or agency

Except for a specific regulatory appointment or authority expressly documented elsewhere, nothing in the Agreement creates a partnership, joint venture, employment, fiduciary or general agency relationship between the parties.

24.5 Waiver

Failure or delay in exercising a right does not waive that right.

24.6 Severability

If any provision is held invalid or unenforceable, it will be modified to the minimum extent necessary or, where modification is not possible, severed without affecting the remainder of the Agreement.

24.7 Entire agreement

The Agreement constitutes the entire agreement between the parties concerning its subject matter and supersedes prior discussions, proposals and representations concerning that subject matter.

Nothing in this clause excludes liability for fraud or fraudulent misrepresentation.

24.8 Third-party rights

Except where expressly stated otherwise, a person who is not a party to the Agreement has no right under the Contracts (Rights of Third Parties) Act 1999 to enforce it.

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25. Governing Law and Jurisdiction

25.1

The Agreement and any dispute or claim arising out of or in connection with it, including non-contractual disputes or claims, are governed by the laws of England and Wales.

25.2

The courts of England and Wales have exclusive jurisdiction to settle any dispute or claim arising out of or in connection with the Agreement.

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26. Blue Peak Details

Blue Peak Consulting Group Ltd

7a Eastgate Street

Winchester

England

SO23 8EB

United Kingdom

Company number: 13877728

Email: info@bluepeakconsulting.co.uk