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PRECEDENTS
This Agreement is made on [insert date] parties 1 [insert name of customer ][of OR a company incorporated in [England and Wales] under number [insert registered number] whose registered office is at ][insert address] (Customer); and 2 [insert name of manufacturer][ of OR a company incorporated in [England and Wales] under number [insert registered number] whose registered office is at ][insert address] (Manufacturer), each of the Customer and the Manufacturer being a party and together the Customer and the Manufacturer are the parties. Background: (A) The Customer Group[ manufactures, distributes and sells [insert]]. (B) The Manufacturer has the facilities, production capacity, technical knowledge, personnel, skills and experience to manufacture the Product. (C) The Customer wishes to purchase, and the Manufacturer wishes to Manufacture and sell to the Customer, the Product on the terms and conditions of this Agreement. (D) The Customer shall place orders for the Product, the Manufacturer shall supply the Customer with such Product and the Customer shall pay the Price for the Product, in accordance with the terms and conditions of this Agreement. The parties agree: 1 Definitions and interpretation In this Agreement: Affiliate • means any entity that directly or indirectly Controls, is Controlled by or is under common Control
PRECEDENTS
This Agreement is made on [insert date] parties 1 [insert name of manufacturer ][of OR a company incorporated in [England and Wales] under number [insert registered number] whose registered office is at ][insert address] (Manufacturer); and 2 [insert name of customer][ of OR a company incorporated in [England and Wales] under number [insert registered number] whose registered office is at ][insert address] (Customer), each of the Manufacturer and the Customer being a party and together the Manufacturer and the Customer are the parties. Background: (A) The Manufacturer is a manufacturer of [insert]. (B) The Customer Group distributes and sells [insert]. (C) The Manufacturer wishes to Manufacture and sell to the Customer, and the Customer wishes to purchase, the Product on the terms and conditions of this Agreement. The parties agree: 1 Definitions and interpretation In this Agreement: Affiliate • means any entity that directly or indirectly Controls, is Controlled by or is under common Control with, another entity; [Agreed Price Period • means the first Contract Year and any subsequent consecutive periods agreed pursuant to clause 8.4 or, in the absence of agreement, the next Contract Year;] Agreement • means this Manufacturing Agreement; Applicable Laws • means: (a) any law, statute, regulation, by-law or
GLOSSARY
A manufacturing defect describes a fault arising from the production process that causes an individual product to depart from the intended design and render it unsafe or of unsatisfactory quality. In practice, it covers problems such as contamination, incorrect assembly, sub‑standard components or failure to meet specified tolerances in a single batch or item.Across England and Wales, Scotland and Northern Ireland, the concept underpins product liability and consumer protection claims, particularly under the Consumer Protection Act 1987, the Consumer Rights Act 2015 and related negligence principles, although “manufacturing defect” itself is largely a descriptive, practitioner‑led term rather than a defined statutory expression.In Ireland, similar issues are addressed under the Liability for Defective Products Act 1991, Sale of Goods and consumer legislation, with courts likewise focussing on whether the product failed to meet the safety or quality a person is entitled to expect due to a production error, as opposed to an inherent design flaw or inadequate warnings.The term is widely used in litigation, regulatory investigations, recall strategies and contractual allocation of risk in supply and manufacturing agreements.
PRACTICE NOTES
Manufacturers of medicinal products must comply with certain minimum standards in their production processes. These minimum standards are known as good manufacturing practice (GMP). GMP requires that medicines are of consistent high quality, are appropriate for their intended use and meet the requirements of the marketing authorisation (MA) or clinical trial authorisation (CTA). The principles of GMP are applicable to the manufacture of both human medicinal products and veterinary medicinal products, as well as the active substances used in medicinal products and investigational medicinal products (IMPs) (ie medicines used in clinical trials). This Practice Note explores the legislation and guidelines that govern the manufacturing of medicinal products for human use, active substances and IMPs in the EU and in the UK. The coronavirus (COVID-19) pandemic significantly impacted the regulation of the manufacturing of medicinal products which falls outside the scope of this Practice Note. The extraordinary regulatory flexibilities for medicines during the COVID-19 pandemic addressed supply challenges and have now been phased out while lessons from the pandemic have driven proposals for
Q&As
We refer you to News Analysis: Brexit Bulletin—key updates, research tips and resources, in particular section: What happens to Brexit SIs during the implementation period? The UK and the EU reached an agreement on the legal terms of the UK's withdrawal from the EU and the European Atomic Energy Community (Withdrawal Agreement) in October 2019, which was ratified by both parties in January 2020. The European Union (Withdrawal Agreement) Act 2020 (EU(WA)A 2020), provides for the domestic implementation of the Withdrawal Agreement in UK law. The EU Member States did not require specific implementing legislation, as it is assumed that the Withdrawal Agreement has direct effect as an international treaty under EU law. As noted in the above News Analysis, key provisions of the European Union (Withdrawal) Act 2018 (EU(W)A 2018), and associated Brexit-related legislation (including Brexit SIs),
NEWS
An EU committee has found that 'many pharmaceuticals' fall under the definition of per- and polyfluorinated alkyl substances (PFAS) proposed for the implementation of the Water Framework Directive. The directive requires the European Commission to set standards for substances that pose significant risks to the aquatic environment; the Commission proposed a standard in response. The European Parliament proposed amendments which resulted in a draft dossier with six options. The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) then reviewed the dossier and has released its scientific opinion finding the compounds covered by the definition of a PFAS total may present 'important regulatory implications for the pharmaceutical industry.' The PFAS criteria in the standards dossier 'implies that many pharmaceuticals and pesticides will fall under the definition,' the SCHEER report stated.
NEWS
The Home Office has published its visa fees table for applications on and after 8 April 2026. The table shows that many visa and sponsorship fees are rising from that date, at a level of 6% or 7%. For example, the general fee for in-country settlement is going up from £3,029 to £3,226, the fee for an Electronic Travel Authorisation (ETA) is going up from £16 to £20, and the fee for a Skilled Worker entry clearance for three years or less sponsorship is going up from £769 to £819. Fees which are staying the same include priority and premium services fees, fees in the Global Talent, High Potential Individual and Innovator Founder routes, Certificate of Sponsorship fees across all sponsored routes, and certificates of entitlement to the Right of Abode. Nationality registration application fees for a child are being reduced by £214. The Home Office has also published a separate transparency data table, which shows the percentage raise in fees (where relevant) and the unit cost to the Home Office of each type of application.
NEWS
Natural England (NE) has published a report on identifying functionally linked land which supports Special Protection Areas (SPA) water birds in the North West of England. The report collates evidence from existing bird records and creates maps which show where important supporting habitats are located, improving understanding of which bird species are using such sites. It aims to ensure that the current geographical spread of supporting habitats across North West England is maintained and enhanced, ensuring the integrity of the SPA sites is protected in the long term. The maps produced as part of the study will also be used when providing advice to local planning authorities and developers on the potential impacts of developing on the functionally linked land, and will inform strategic mitigation and compensation areas in order to target biodiversity net gain, habitat creation and enhancement opportunities.
NEWS
David Wolfe KC of Matrix Chambers and Leon Glenister of Landmark Chambers, both public law barristers with significant experience and expertise in Special Educational Needs (SEN) law, have published the March 2026 version of 'Noddy No-nonsense Guide to SEN law'. The guide is a regularly updated free public resource to assist all those who deal with SEN law in England, including judges, legal practitioners, schools, parents and local authorities.
GLOSSARY
Additional percentage added to an interest rate to create the final rate.
PRACTICE NOTES
The introduction of margin requirements for non-cleared derivatives has required significant changes to infrastructure, processes, models and documentation. This Practice Note provides information on the initiatives of the International Swaps and Derivatives Association (ISDA) and other industry bodies to help firms meet the requirements. ISDA SIMM™ documents ISDA has published its Standard Initial Margin Model (ISDA SIMM™), which provides a standard methodology to use when calculating IM amounts by reference to a quantitative portfolio margin model (one of the two approaches permitted by the BCBS-IOSCO Margin requirements for non-centrally cleared derivatives). The aim of the ISDA SIMM™ is for the process of calculating IM to become largely standardised, so that there are fewer calculations that need to be made and the calculations may be done consistently. Potentially, firms can use their own internal models to calculate IM if those models meet set criteria and have received regulatory approval, but, the risk is that these models will differ significantly between firms and jurisdictions, leading to disputes arising as counterparties may not agree on the IM that needs
PRACTICE NOTES
Introduction to margin loans What is a margin loan? In broad terms, a margin loan is a loan made to a borrower against the value of liquid assets which are secured in favour of the lender. The collateral assets are typically traded on a public market or exchange, the most common example being listed shares owned by the borrower. The amount outstanding under the margin loan facility is tested against the value of the underlying assets, which is known as the loan to value test. If the value of the secured assets falls below an agreed level, a ‘margin call’ is triggered, requiring the borrower to take action (usually by providing additional cash or other collateral) to restore the loan to value ratio to the agreed level. As the value of the assets are defined by reference to the price of the securities on the exchange, the loan to value can fluctuate rapidly and so it generally is tested on a daily basis at the time of closing of trading