Terms applying to suppliers of goods and services to Vitalex Ltd
1. About Vitalex Ltd
Vitalex Ltd is a company registered in England and Wales under company number 16068365. Our registered office is The Stamp Exchange, 7 Westgate Road, Newcastle upon Tyne, NE1 1SA. Our website is www.vitalexltd.co.uk.
2. Application and contract formation
These Conditions apply to purchase orders issued by Vitalex Ltd unless a signed supplier, manufacturing, distribution or quality agreement expressly states otherwise. The Supplier accepts these Conditions by acknowledging the purchase order, starting work, shipping Goods or performing Services.
Supplier terms do not apply unless Vitalex Ltd expressly accepts them in writing. If there is a conflict, the following order applies: (1) signed agreement; (2) Vitalex purchase order and its schedules/specifications; (3) approved quality or regulatory agreement; (4) these Conditions.
3. Definitions
- ▪ “Goods” includes medical devices, procedure packs, drapes, gowns, components, packaging, labels and other products identified in a Purchase Order.
- ▪ “Services” includes manufacturing, assembly, sterilisation, testing, transport, warehousing, consultancy, waste/recovery or other services identified in a Purchase Order.
- ▪ “Specification” includes drawings, pack/component lists, quality requirements, labels, packaging, regulatory documentation and any approved change controlled by the parties.
- ▪ “Supplier” includes the person or organisation accepting the Purchase Order and its approved subcontractors.
4. Supplier warranties
The Supplier warrants that Goods and Services will:
- ▪ conform in all material respects to the Purchase Order, approved Specification, samples and agreed quality requirements;
- ▪ be of satisfactory quality, fit for any purpose expressly made known and free from material defects in design, materials and workmanship to the extent the Supplier is responsible for those matters;
- ▪ comply with applicable law, standards, licences, approvals and regulatory requirements in the market for which Vitalex Ltd has stated the Goods are intended;
- ▪ be supplied with accurate, complete and current regulatory, technical, quality, traceability and safety information required by the Purchase Order or applicable law; and
- ▪ not knowingly infringe third-party intellectual-property rights when used for their intended contractual purpose.
5. Medical-device and procedure-pack regulatory requirements
Where Goods are medical devices or form part of a system/procedure pack, the Supplier must identify in writing the legal manufacturer and, where applicable, the importer, distributor, UK Responsible Person, conformity-assessment body and registration arrangements relevant to the intended market.
The Supplier must not place the Vitalex Ltd name, address, trade mark or branding on a medical device or its packaging in a way that makes or could make Vitalex Ltd the legal manufacturer or virtual manufacturer unless Vitalex Ltd has expressly approved the regulatory model in writing and the required technical-documentation, quality, registration, declaration, post-market and contractual arrangements are already in place.
The Supplier must ensure the Goods have the correct conformity marking or lawful transitional status for the intended market. It must not represent UKCA as sufficient for Northern Ireland where it is not, or otherwise provide inaccurate regulatory statements.
Where the Supplier assembles a system or procedure pack, it must ensure that the components, intended purposes, compatibility, assembly, labelling, sterilisation and conformity route are lawful and validated for the arrangement being supplied. The Supplier must promptly inform Vitalex Ltd if the requested configuration would cause a different or additional manufacturer/conformity obligation.
6. Quality management and manufacturing controls
Where relevant to the Goods or Services, the Supplier must maintain an appropriate documented quality-management system and provide evidence of certification where contractually required. Where manufacture is stated to occur in an ISO 13485-certified facility, the Supplier must keep the relevant certificate current and notify Vitalex Ltd promptly of suspension, withdrawal, material scope change or adverse audit outcome affecting supplied Goods.
The Supplier must maintain appropriate controls for supplier qualification, incoming materials, production, environmental/cleanroom conditions where applicable, process validation, inspection, testing, release, non-conformance, CAPA, complaint handling, traceability, change control and records.
7. Sterilisation and sterile barrier
Where Goods are supplied sterile, the Supplier must use a validated sterilisation process appropriate to the Goods and maintain evidence of validation, routine control and release. Packaging and sterile-barrier systems must be suitable for the validated shelf life, transport and storage conditions. The Supplier must notify Vitalex Ltd immediately of any sterilisation, packaging-integrity or release concern affecting Goods already supplied or in production.
8. Traceability, lot and expiry data
The Supplier must maintain traceability sufficient to identify the manufacturing lot/batch, relevant components, sterilisation lot where applicable, release status, expiry/shelf-life data and quantities supplied to Vitalex Ltd. Information required for a complaint, recall, field safety action or regulatory investigation must be provided without undue delay.
Unless a longer period is required by law, device class, technical documentation, a quality agreement or the Purchase Order, records relating to supplied medical devices should be retained for at least 10 years after the last relevant delivery. The parties may agree a different period where legally appropriate.
9. Change control
The Supplier must not make a material change to the Goods, Specification, component source, legal manufacturer, manufacturing site, sterilisation process/site, cleanroom, critical material, label, packaging, intended purpose, conformity route, certificate, UK Responsible Person or other regulated feature without prior written notification to Vitalex Ltd and any approval required by the Purchase Order or quality agreement.
The Supplier should provide at least 90 days’ advance notice of planned material changes where practicable. Safety, regulatory or urgent supply changes must be notified immediately. Vitalex Ltd may require samples, validation evidence, updated documentation or written approval before accepting changed Goods.
10. Non-conformance, CAPA and complaints
The Supplier must investigate actual or suspected non-conforming Goods and product complaints promptly, provide a documented root-cause analysis and CAPA where appropriate, and cooperate with Vitalex Ltd in determining the affected scope. Vitalex Ltd may reject, quarantine, return, rework by agreement, require replacement or require other reasonable corrective action for non-conforming Goods.
11. Incidents, vigilance, recalls and field safety corrective action
The Supplier must immediately notify Vitalex Ltd of any serious incident, safety signal, trend, regulator communication, Field Safety Notice, field safety corrective action, recall, conformity concern or other matter that may affect Goods supplied or ordered. The Supplier must provide the information Vitalex Ltd reasonably needs to identify affected customers, lots and quantities and to meet its own contractual or regulatory responsibilities.
The Supplier must cooperate fully in containment, investigation, communication, recovery, replacement, regulatory reporting and effectiveness checks. Costs will be allocated according to responsibility and the applicable contract; the Supplier is responsible for reasonable costs to the extent the action results from the Supplier’s breach, defect or regulatory non-compliance.
12. Audit and access to records
On reasonable notice, Vitalex Ltd or its authorised representative may audit the Supplier’s relevant quality, regulatory, ethical-sourcing and continuity controls where proportionate to the risk and contract. Urgent access may be required without ordinary notice following a serious safety, quality, fraud or regulatory concern. Audits must respect legitimate confidentiality and security restrictions.
13. Delivery, packaging and shelf life
The Supplier must meet the agreed delivery date and delivery terms, package Goods to prevent damage or contamination, and provide correct shipping, batch and expiry information. Time may be of the essence where stated in the Purchase Order or where a delay creates a patient-safety, contractual or critical-stock risk.
Unless otherwise agreed, Goods must have sufficient remaining shelf life on delivery for Vitalex Ltd to supply customers through normal distribution. Any short-dated stock requires prior written approval.
14. Inspection, acceptance and rejection
Receipt, payment or routine inspection does not constitute final acceptance of latent defects or regulatory non-conformance. Vitalex Ltd may reject Goods that do not conform to the Contract and may require replacement, repair, re-performance, refund/credit or another reasonable remedy. Where rejected Goods are held pending instruction, the Supplier remains responsible for reasonable associated costs to the extent the rejection results from Supplier breach.
15. Price and payment
The price is the price stated in the Purchase Order or signed agreement and includes all costs stated to be included there. No price increase is effective without prior written agreement. Unless the Purchase Order or supplier-specific agreement states otherwise, valid undisputed invoices are payable within 30 days after the later of receipt of a correct invoice and acceptance of the relevant Goods or Services.
Where Vitalex Ltd has expressly agreed advance payment, deposit, ex-works or other supplier-specific commercial terms, those written terms override the default payment provision for the affected order.
16. Subcontracting and supply chain
The Supplier must not subcontract a critical manufacturing, sterilisation, quality, regulatory or service activity affecting the Goods without maintaining appropriate controls and, where required by the Contract, obtaining prior written approval. The Supplier remains responsible for approved subcontractors as if their acts and omissions were those of the Supplier.
17. Business continuity and shortages
The Supplier must maintain proportionate business-continuity and contingency arrangements for critical Goods and notify Vitalex Ltd promptly of any actual or anticipated shortage, site interruption, certificate issue, transport restriction or other event likely to affect supply. The Supplier must provide a recovery plan and reasonable allocation/mitigation information where requested.
18. Ethical sourcing, modern slavery and environment
The Supplier must comply with applicable labour, health and safety, anti-bribery, modern-slavery, sanctions, environmental and waste law. It must prohibit forced labour, human trafficking and unlawful child labour and maintain proportionate due diligence in its own supply chain. Vitalex Ltd may request evidence relevant to NHS, public-procurement, sustainability, social-value or customer due-diligence requirements.
Environmental or carbon information supplied to Vitalex Ltd must be accurate, evidence-based and capable of substantiation. The Supplier must not knowingly provide data that would cause Vitalex Ltd to make a misleading environmental claim.
19. Confidentiality and intellectual property
The Supplier must protect Vitalex Ltd confidential information, including customer requirements, preference cards, bespoke pack specifications, pricing, forecasts, product codes and business plans, and use it only to perform the Contract. The Supplier must not use Vitalex Ltd branding or customer names in publicity without written permission.
Ownership and licensing of new intellectual property, tooling, labels, artwork or bespoke specifications will be as stated in the Purchase Order or signed agreement. In the absence of a specific agreement, each party retains its pre-existing intellectual property and grants only the rights reasonably necessary to perform the Contract.
20. Insurance and indemnity
The Supplier must maintain insurance appropriate to the nature and risk of the Goods and Services, including product liability and public liability where relevant, and provide evidence on request.
The Supplier will indemnify Vitalex Ltd against reasonable losses, liabilities, recall/field-action costs, third-party claims and regulatory costs to the extent they result from the Supplier’s breach of Contract, negligence, defective Goods, infringement of third-party intellectual property, or breach of applicable regulatory obligations. This indemnity does not apply to the extent the loss was caused by Vitalex Ltd or another party for whom the Supplier is not responsible.
21. Data protection
Each party must comply with applicable data-protection law. The Supplier must not use Vitalex Ltd customer or employee personal data for its own unrelated purposes and must implement appropriate security. If the Supplier processes personal data on behalf of Vitalex Ltd, the parties must put in place the processor terms required by law before that processing begins.
22. Termination and suspension
Vitalex Ltd may suspend or terminate an order for material breach, repeated quality failure, serious regulatory or safety concern, loss of required certification/authorisation, insolvency where law permits, bribery/modern-slavery concern, or where continued supply would be unlawful. Where practicable, Vitalex Ltd will allow a reasonable cure period for remediable breaches.
23. General
No variation is binding unless agreed in writing by an authorised representative. If a provision is invalid, the remainder continues. No failure to enforce a right is a waiver. The Supplier may not assign the Contract without Vitalex Ltd’s prior written consent, not to be unreasonably withheld where appropriate.
24. Governing law and jurisdiction
These Conditions and any non-contractual obligations arising from them are governed by the law of England and Wales. The courts of England and Wales have exclusive jurisdiction unless the parties agree otherwise in writing.