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Research Use Only Disclaimer

The regulatory framework that governs every product supplied by PerformanceLabsUK Ltd.

This Research Use Only Disclaimer (the "Disclaimer") forms part of the contract between you and PerformanceLabsUK Ltd and is incorporated into our Terms & Conditions by reference. By accessing this Website or placing an Order, you acknowledge that you have read, understood, and agree to be bound by this Disclaimer.

1. Legal Classification of Our Products

All products supplied by PerformanceLabsUK Ltd (the "Products") are research reference materials. The Products are NOT:

medicinal products as defined in regulation 2 of the Human Medicines Regulations 2012;

food or food supplements as defined in the Food Supplements (England) Regulations 2003 or equivalent;

cosmetics as defined in the Cosmetic Products Enforcement Regulations 2013;

medical devices as defined in the Medical Devices Regulations 2002;

veterinary medicines as defined in the Veterinary Medicines Regulations 2013;

controlled drugs as defined in the Misuse of Drugs Act 1971 (except where specifically declined and listed in our Prohibited Products policy).

The Products have NOT been assessed, authorised, or approved by:

the Medicines and Healthcare products Regulatory Agency (MHRA);

the US Food and Drug Administration (FDA);

the European Medicines Agency (EMA);

any other regulatory authority for safety, quality, or efficacy in humans or animals.

Statutory basis: Human Medicines Regulations 2012 regulation 2 and regulation 8; MHRA Guidance Note 8 on borderline products.

2. What the Products Are For

The Products are supplied strictly for in vitro laboratory research use by qualified researchers, academic laboratories, and science-driven professionals. Typical legitimate use cases include:

reference material for analytical chemistry and mass spectrometry calibration;

in vitro assay development and validation;

literature-based research commentary and educational writing;

comparative structural studies and method development;

in vitro biological pathway investigation under suitable laboratory controls.

3. What the Products Are NOT For

You must not, and you acknowledge that the Products are not suitable or authorised for:

human consumption in any form, by any route (oral, injection, sublingual, intranasal, topical, inhalation, or any other);

veterinary or animal use of any kind;

the treatment, prevention, cure, diagnosis, or mitigation of any disease, injury, or physiological condition in humans or animals;

therapeutic, preventative, or palliative purposes of any kind;

performance enhancement, cosmetic use, or recreational use;

onward supply to parties who will administer the Products to humans or animals.

4. No Medicinal or Therapeutic Claims

PerformanceLabsUK Ltd does not make, and has never made, any claim that the Products:

can treat, cure, prevent, diagnose, or mitigate any disease or medical condition;

have any therapeutic effect on humans or animals;

are suitable for any purpose other than in vitro laboratory research;

have been assessed for safety, quality or efficacy in any human or veterinary context.

All product descriptions on the Website are written with reference to the published scientific literature and describe mechanism, structure, and research context only. They are not recommendations, instructions for use, or endorsements of any application of the Products.

Statutory basis: Human Medicines Regulations 2012 Part 14; CAP Code rules 12.1 and 12.2; Consumer Protection from Unfair Trading Regulations 2008.

5. Purchaser Responsibilities

By placing an Order, you confirm and accept that:

you are aged 18 or over;

you are purchasing the Products for research-use purposes only and not for human or veterinary consumption;

you will store, handle, and dispose of the Products in accordance with applicable research laboratory standards and local health and safety rules;

you accept full and sole responsibility for the Products following delivery, including any consequences arising from any use, application, or administration of the Products;

you will not onward-supply the Products to any party who will administer them to humans or animals.

6. Indemnity

You agree to indemnify and hold harmless PerformanceLabsUK Ltd, its directors, employees, and agents against any and all claims, costs, losses, damages, liabilities, fines, penalties, and expenses (including reasonable legal fees) arising from or in connection with:

your breach of this Disclaimer;

your use of the Products otherwise than in accordance with clause 2;

any consumption, application, or administration of the Products to the human body or to any animal body;

any regulatory action, customs action, or law enforcement action arising from your conduct.

7. Acknowledgement at Checkout

At checkout, you will be required to tick an un-pre-ticked box affirming:

"I am 18 years of age or older. I am purchasing these Goods strictly for in vitro laboratory research use, not for human or veterinary consumption. I have read, understood, and accept the Terms & Conditions, the Refund & Returns Policy, and this Research Use Only Disclaimer. I am not located in, and will not ship to, any jurisdiction listed in the Prohibited Jurisdictions Policy."

Orders cannot be placed without this confirmation. PerformanceLabsUK Ltd retains a record of each confirmation for 7 years as evidence of the research-use intent declared by each Purchaser.