TamRx Ltd

Last updated: 28 October 2025

In these Terms:

• “Company” means TamRx Ltd, Company No. 16596160, registered in England and Wales.
   
• “Client” means any individual or legal entity purchasing services from TamRx.
   
• “Services” means analytical, advisory, and consulting services described in proposals, statements of work, or invoices.
   
• “Deliverables” means reports, analyses, models, figures, and written outputs produced by TamRx.
   
• “Agreement” means these Terms together with any proposal, statement of work, or contract accepted by the Client.
   
• “Working Day” means a business day in England.
   

Headings are for convenience only and do not affect interpretation.

2.1 TamRx provides analytical and advisory services only.
TamRx does not:

• manufacture products,
   
• release batches,
   
• approve specifications,
   
• file regulatory submissions,
   
• act as a regulatory authority,
   
• provide legal or clinical advice.
   

2.2 All Services are provided to support internal decision-making by the Client.
Final responsibility for GMP compliance, quality decisions, regulatory actions, and implementation remains solely with the Client.

3.1 Analyses are based on:

• data supplied by the Client,
   
• assumptions explicitly stated in Deliverables,
   
• statistical and risk-based methodologies.
   

3.2 TamRx does not warrant that:

• outcomes will be achieved,
   
• regulatory authorities will accept any decision,
   
• future events will conform to modelled scenarios.
   

3.3 Results represent decision-support information, not predictions or guarantees.

The Client shall:

• ensure data provided is accurate, lawful, and anonymised where required;
   
• retain responsibility for all GMP, regulatory, and quality decisions;
   
• review Deliverables before use;
   
• ensure internal approvals are obtained before relying on Services.
   

TamRx is not responsible for errors arising from incomplete, inaccurate, or misleading Client data.

5.1 Deliverables are deemed accepted upon:

• delivery to the Client, or
   
• use by the Client.
   

5.2 Minor clarifications or corrections may be requested within 5 Working Days of delivery.

5.3 Substantive changes outside the agreed scope constitute additional work and may be charged separately.

Indicative services include (unless otherwise agreed):

ServiceDescriptionTurnaroundFeeOOT Trend AnalysisStatistical profiling of batch trends + advisory context (5-page PDF)2 Working Days£2,500Full OOS Investigation SupportICH Q9-aligned risk assessment with stress testing (20–30 pages)5 Working Days£7,500QC Compliance RetainerMonthly monitoring and advisory supportOngoing£1,500 / month 

All fees are exclusive of VAT (where applicable).

• Invoices are payable within 14 days of issue unless otherwise agreed.
   
• Late payments may accrue interest under the Late Payment of Commercial Debts (Interest) Act 1998.
   
• TamRx reserves the right to suspend Services for overdue accounts.
   

7.1 Professional services are non-refundable once work has commenced.

7.2 If the Client cancels:

• before work begins → no charge;
   
• after work begins → fees payable for work performed to date.
   

7.3 No refunds are provided for:

• dissatisfaction with conclusions,
   
• regulatory outcomes,
   
• internal business decisions.
   

8.1 All background IP, methodologies, templates, models, and know-how remain the property of TamRx.

8.2 Upon full payment, the Client receives a non-exclusive, non-transferable licence to use Deliverables internally only.

8.3 Deliverables may not be:

• resold,
   
• sublicensed,
   
• publicly disclosed,
   
• used in regulatory submissions,
  without TamRx’s prior written consent.
   

9.1 Each party shall keep confidential all non-public information received.

9.2 TamRx may reference anonymised, aggregated work for internal learning but will not disclose Client identity without consent.

9.3 Confidentiality obligations survive termination.

10.1 Each party shall comply with:

• UK GDPR,
   
• Data Protection Act 2018,
   
• applicable international data protection laws.
   

10.2 TamRx processes only anonymised, non-patient, non-clinical data unless otherwise agreed in writing.

Nothing excludes liability for:

• death or personal injury caused by negligence;
   
• fraud or fraudulent misrepresentation;
   
• liabilities that cannot be excluded by law.
   

To the maximum extent permitted by law:

• TamRx shall not be liable for:
   
  • loss of profit,
     
  • loss of business,
     
  • regulatory penalties,
     
  • inspection outcomes,
     
  • consequential or indirect losses.
     
• TamRx’s total aggregate liability under any Agreement shall not exceed the fees paid by the Client for the relevant Services.
   

The Client indemnifies TamRx against claims arising from:

• misuse of Deliverables,
   
• regulatory filings made without consent,
   
• reliance beyond stated scope,
   
• Client data inaccuracies.
   

Neither party shall be liable for failure caused by events beyond reasonable control, including but not limited to:

• system outages,
   
• government action,
   
• natural disasters,
   
• pandemics.
   

14.1 Either party may terminate for material breach with 14 days’ written notice.

14.2 Upon termination:

• outstanding fees remain payable;
   
• confidentiality and IP clauses survive.
   

This Agreement is governed by the laws of England and Wales.

The courts of England and Wales have exclusive jurisdiction, unless otherwise agreed in writing.

Where Services are provided internationally:

• UK law governs unless explicitly agreed otherwise;
   
• the Client is responsible for local regulatory compliance;
   
• nothing in these Terms creates a local presence or establishment.
   

These Terms constitute the entire agreement between the parties and supersede prior discussions.

No reliance is placed on representations not expressly set out herein.

TamRx may update these Terms periodically.
Updated Terms apply to future engagements only.

TamRx Ltd
Nexus, Discovery Way, Leeds LS2 3AA
Email: mounsif@tamrx.co.uk