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What are pharmaceutical incentives? In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives (PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection (MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product. Rationale behind PIs PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development (R&D) costs of creating it and can therefore sell the
Claims by contractors for time and/or money Requests from contractors seeking additional time and/or payment are commonplace on construction projects. A time claim seeks an extension of time (EoT) to complete the works (or achieve a contractual milestone) where a delay event has occurred, whereas a money claim typically pursues reimbursement of extra loss and/or expense incurred by the contractor due to delay or disruption to the works. Such a claim might likewise be brought by a sub-contractor under a sub-contract. These claims are usually founded on an express contractual entitlement—ie the contract specifies situations in which the contractor is entitled to time and/or money—and they are advanced and decided in accordance with the contract terms. They do not, of themselves, involve a breach of contract or require there to be a dispute between the parties, although they may ultimately give rise to
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) whose registered office is at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) whose registered office is at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) whose registered office is at ] [ address ] (Guarantor) ] 1 Definitions For this Deed, the terms below shall have the following meanings: Effective Date • [ today OR the date of this Deed OR [ other date on which the variation is to take effect ] ] [ Guarantor’s Obligations • the covenants undertaken by the Guarantor in [ the Lease OR a [ describe other
Most recent Checklists
The Financial Conduct Authority’s ( FCA) Consumer Duty The Financial Conduct Authority’s ( FCA) Consumer Duty sets a high bar for the care firms must deliver to retail customers. It has applied to new and existing products and services open to sale or renewal from July 2023, and to closed-book products and services from July 2024. The FCA continues to release materials to support firms with implementing and embedding the Consumer Duty. This timeline summarises publications and developments connected to the Duty. The Duty comprises high-level, outcomes-focused requirements that apply to firms operating in retail markets for regulated financial services and products. It covers all firms involved in the creation, provision, operation, marketing, or distribution of products and services offered to retail customers—whether or not a direct customer relationship exists with the end user. For fuller information on the FCA’s Consumer Duty and its...
Scope of this Checklist This Checklist outlines the considerations when a company plans to grant a fixed charge. It assumes an English or Welsh company will confer multiple fixed charges on a lender located in England or Wales. In this Checklist: the company giving the fixed charge is the ‘chargor’ the recipient of the charge is the ‘chargee’ the instrument recording the fixed charge is the ‘security document’ Fixed charges may be created in a standalone security document or as part of the security within a debenture (see: Documentation required to create a fixed charge below). For further details, see: Practice Note: Fixed and floating charges. Preliminary questions before taking security by way of a fixed charge Is a fixed charge the appropriate method of taking security? A fixed charge may be granted by a...
How to use this Checklist Establishing a website can deliver substantial advantages for a business’s online presence. However, in the process a business may face infringing behaviour by competitors or others, including AI-enabled scraping of content. This Checklist sets out the main matters to weigh up when handling or acquiring website materials—such as programme code, text, graphics, images and multimedia. Pinpoint intellectual property rights ( IPRs) and ownership; technical protection measures ( TPMs); terms of use; special contractual terms; monitoring; copyright policy; data privacy; intellectual property notices; taking action against infringers; domain names. It does not address issues relating to website development, compliance or management, nor the use or upload of user-generated content. If dealing with website development or with website management and compliance, see: Practice Note: Website design and...
Background Statutory declarations form an essential component of insolvency processes, arising most frequently when a company proceeds by members’ voluntary liquidation ( MVL) under section 89 of the Insolvency Act 1986 ( IA 1986), and also when administration is commenced by an out-of-court appointment in accordance with the Insolvency ( England and Wales) Rules 2016 ( IR 2016), SI 2016/1024, r 3.17. Section 20 of the Statutory Declarations Act 1835 ( SDA 1835) sets out the required form of the declaration, as contained in the Schedule to that Act. Under SDA 1835, s 19, a fee is payable, the amount of which is fixed by the Commissioners for Oaths ( Fees) Order 1993, SI 1993/2297. The fee is £5 for taking an affidavit, declaration, or affirmation, together with an additional £2 for each exhibit referred to therein that must be marked, or for every...
The below tables provide an overview of: various factors that do not necessitate distinct classes (ie do not split the class) various factors that have been treated as warranting distinct classes (ie do split the class) in Part 26 scheme and Part 26A restructuring plan cases Judges have held that the caselaw on schemes is equally applicable to restructuring plans on many issues (see Re Pizza Express (convening) and Re Virgin Atlantic), including class formation, although the Court of Appeal in Adler confirms that cross-class cramdown ( CCCD) in restructuring plans does require different considerations; see Practice Note: Cross- Class Cram Down under a Part 26A restructuring plan. As a note of caution, it is important to recognise that class analysis is highly fact-specific, and it is possible that another judge, faced with a slightly different factual pattern, might reach a...
Checklist This Checklist presents a consolidated, structured timeline for the EU Markets in Crypto- Assets Regulation, Regulation ( EU) 2023/1114 ( Mi CA Regulation), which took effect on 29 June 2023. It covers the staggered roll-out of the Level 1 regime ( Phase 1) and the progression of Level 2 and 3 measures. The Checklist sets out the principal legislative milestones and commencement dates before and after the Phase 1 implementation of the Mi CA Regulation, together with the continuing development of regulatory technical standards ( RTS), implementing technical standards ( ITS), guidelines, Q& As and other supervisory actions issued by the European Securities and Markets Authority ( ESMA), the European Banking Authority ( EBA) and other relevant authorities. For material centred on how EU authorities regulate cryptoassets, see Practice Note: EU regulation of cryptoassets. To explore the stance adopted by...
How to use this checklist This Checklist sets out the principal obligations for traders who provide subscription arrangements under the Digital Markets, Competition and Consumers Act 2024 ( DMCCA 2024). It addresses which agreements are captured by the subscription regime, how those rules operate for free trials, the pre-contract information to be given, reminder communications, and consumers’ rights to cancel. It also covers cooling-off entitlements and refunds. This Checklist serves as a practical aid to traders gearing up for commencement of the pertinent provisions of DMCCA 2024, Part 4, Chapter 2. DMCCA 2024 secured Royal Assent on 24 May 2024, with some elements taking effect from that day. Nevertheless, the bulk of the significant provisions and duties in the DMCCA 2024 will commence through secondary legislation. The government has set out its indicative schedule for commencement of the substantive elements of DMCCA 2024: DMCCA 2024, Part 4,...
How to use this checklist This checklist sets out the key points to consider when seeking to exploit your IP rights in the UK. It is split into four separate checklists-the first addresses how to shape an IP strategy and efficiently manage your IP rights, the second details the principal steps when assigning an IP right, the third covers how to licence your IP, and the fourth provides guidance on granting a security over your IP right. It is intended to be used alongside Practice Note: How to exploit your IP rights... Checklist for exploitation of IP rights-strategy and management The third column can be used to record observations or comments as the checklist is worked through... Checklist Further information Notes (if any) Preliminary steps ☐ Establish ownership of the IP right To exploit an IP right, you must either own the right or have the...
This timeline outlines key milestones relating to UK operational resilience requirements for financial services firms from January 2024 onwards. For earlier milestones, see: Operational resilience—timeline [ Archived]. 2026 18 March 2026 — Bo E, FCA, PRA FCA confirms new incident and third party rules to reinforce resilience. PS26/2: Operational incident and third party reporting Finalised Guidance: Operational Incident Reporting ( FG26/3) Finalised Guidance: Material Third Party Reporting ( FG26/4) Reporting operational incidents PS7/26— Operational resilience: Operational incident and third-party reporting SS1/26— Operational resilience: Incident reporting Operational resilience: operational incident and outsourcing and third-party reporting FMIs (policy statement and consultation paper) Operational resilience: operational incident and outsourcing and third-party reporting FMIs (supervisory statement) Updated outsourcing and third-party risk management: central counterparties (supervisory statement) Updated outsourcing and third-party risk management: central securities depositories...
Judicial review Judicial review is the process through which the courts exercise a supervisory jurisdiction over the performance of public functions by public bodies......
This Practice Note sets out detailed, relevant guidance on the principal legal and regulatory compliance obligations that a website operator should take into account within the EU, covering the following areas: the type and functionality of the website information disclosure requirements consumer protection data protection and privacy cookies accessibility cyber security platform-to-business online payments advertising, promotions and direct marketing AI competition law taxation liability for third party content intellectual property and observance of copyright geographic and territorial considerations Topics such as electronic data interchange ( EDI), blockchain, smart contracts, or sector-specific laws and regulations—including those relating to financial services, intermediation services, or online auctions—fall outside the scope of this Practice Note. This Practice Note addresses only legislation that has been adopted to date by the EU. For further details on...
This checklist outlines the key requirements of Regulation ( EU) 2023/2854, the EU Data Act It sets out what businesses must adhere to, including the following areas: data access and portability smart contracts prohibition on unfair contractual terms right to switch services (operability) open interoperability rules on international data transfers The EU Data Act is designed to foster business-to-business ( B2B) and business-to-consumers ( B2C) data sharing from Internet of Things ( Io T) devices, promoting fair use of data and enabling the EU to realise the full potential of its data economy. It represents the second major legislative step under the European strategy for data, following Regulation ( EU) 2022/868, the EU Data Governance Act. Where the EU Data Governance Act establishes the mechanisms and structures that allow companies, individuals and the public sector to share data, the EU Data Act...
Checklist When taking charge of a new team, establishing trust with your new colleagues swiftly is essential to unlock peak performance. You will, unavoidably, meet conflict and challenge; handling this promptly and well will ensure it does not undermine your outcomes. This Checklist helps you assess the way you cultivate trust and deal with conflict within a team, while highlighting where you might improve and to spot potential areas for development in your approach and day-to-day practice over time......
STOP PRESS: The Financial Remedies Guide 2026, released on 13 March 2026 by Mr Justice Peel ( National Lead Judge of the Financial Remedies Court) and His Honour Judge Hess ( Deputy National Lead Judge of the Financial Remedies Court), and approved by the President of the Family Division, now replaces and supersedes: the Statement on the efficient conduct of financial remedy cases assigned to a High Court judge, whether heard at the Royal Courts of Justice or elsewhere (1 February 2016) (the High Court judge level efficiency statement) the Statement on the efficient conduct of financial remedy hearings in the Financial Remedies Court below High Court judge level (11 January 2022) (the below High Court judge level efficiency statement) the Financial Remedies Court Primary Principles document (11 January 2022) the Notice from the Financial Remedies Court: electronic bundles (19 April 2022) the Allocation of financial remedies cases to High Court...
This Checklist outlines the principal considerations when preparing a schedule to a business‑to‑business agreement. For further guidance on drafting commercial contracts, in general, see: Practice Note: Key terms and conditions in commercial contracts Practice Note: Structure and form of commercial contracts Commercial contract drafting and review-checklist Commercial contract review and execution (business personnel)-checklist What are schedules used for? Schedules to an agreement typically hold detailed information about particular aspects of the deal or deviations from a standard contract, and they commonly address commercial matters. These may cover pricing and charges, key personnel, service levels and service credits, technical specifications and statements of work (e.g. details of licensed software, scope of services to be performed, descriptions of products to be provided), territories covered, sales targets, governance, business continuity and disaster recovery, and policies. In more intricate agreements, the appropriate commercial teams within the...
Checklist The Insolvency Act 1986 ( IA 1986) and the Insolvency ( England and Wales) Rules 1986 ( IR 2016), SI 2016/1024, confer on insolvency office-holders the authority to secure possession of a company’s or bankrupt’s property—covering books, papers, accounts and other records—and to oblige specified individuals or entities to deliver up information concerning the affairs and assets of the insolvent company or individual. For further reference, see: Evidence and evidence gathering—overview. This checklist charts the steps from the first request for information or property through to an application to the court. Investigate the background events and circumstances that led to the company’s insolvency or the individual’s bankruptcy. For companies, this includes seeking delivery up of the company’s property and obtaining production of books, papers and other records (including accounting information and bank statements) to which the company appears to be entitled, and...
This flowchart outlines the steps an employer should take once a performance or capability concern is identified, including collecting key documents such as the contract of employment and appraisal records, considering mediation, appointing who will carry out performance monitoring, arranging informal and then formal meetings, deciding on dismissal or another sanction, and overseeing the appeal stage. Click below to view or print the full-size PDF version: Note 1—identifying whether there is a performance issue If an employee’s output falls short of the required standard, the employer may choose to address it under its performance procedure. For an example procedure, see Precedent: Policy and procedure—performance and capability. A clear distinction should be drawn between misconduct and underperformance. Where conduct is the concern, a disciplinary process is the correct route—see Practice Note: Managing performance— Dealing with poor performance. Before commencing any formal action, review the terms of the...
Anti-bribery and corruption Checklist This anti-bribery and corruption Checklist helps you assess whether your systems meet the Bribery Act 2010 ( BA 2010) and the government’s guidance on bribery and corruption. Read it together with these subtopics: Anti-bribery and corruption—regulatory regime Anti-bribery and corruption— Identifying & assessing risks Anti-bribery and corruption—policy and procedures, or for law firms, Anti-bribery and corruption—policy and procedures—law firms Anti-bribery and corruption—gifts and hospitality Anti-bribery and corruption—agents and intermediaries Anti-bribery and corruption—joint ventures and acquisitions Anti-bribery and corruption—charitable and political donations Anti-bribery and corruption—staff training & awareness, or for law firms, Anti-bribery and corruption—staff training and awareness—law firms Anti-bribery and corruption—monitoring and review This Checklist signposts relevant Precedents you can use or tailor to satisfy these requirements and recommendations. It includes a box to indicate whether each item has been...
Search orders Formerly known as Anton Piller orders, search orders are frequently made in conjunction with a freezing order and permit an applicant to attend at the respondent’s premises to search for and safeguard evidence that might otherwise be disposed of, concealed, or destroyed. The order may only be served by a supervising solicitor and is subject to very strict requirements as set out in the Family Procedure Rules 2010 ( FPR 2010), SI 2010/2955. The adoption of Anton Piller relief, now codified within FPR 2010 as search orders, gained prominence in family proceedings through two authorities on disclosure and self‑help ( L v L and Tchenguiz v Imerman; Imerman v Imerman). The courts have issued a firm caution against self‑help in preference to pursuing the proper court‑based remedies; see Practice Note: Procedural aspects of disclosure in financial proceedings— Disclosure of documents...
For comprehensive guidance on setting up a private company limited by shares, consult Practice Note: Incorporating a company. Matter to be considered or step to be taken Companies Act 2006 ( CA 2006) reference (if applicable) Tick box when step complete or matter considered Preparing to incorporate a private company limited by shares Decide if the company will be bespoke on formation or obtained ‘off the shelf’. Where the company is to be tailor made, move on to the remaining considerations and actions in this checklist. N/ A Who are the initial shareholders (also known......
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When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...
This Practice Note This Practice Note reviews mechanisms used in settling litigation. A Tomlin order consists of a consent order paired with a schedule. It operates to stay proceedings on terms that have been agreed. The provisions contained in the schedule may remain confidential. This Practice Note describes the scope of confidentiality attaching to the schedule and sets out how it differs from a standard consent order. Sample wording for a Tomlin order is included, alongside links to precedents, as well as guidance on court approval. It also addresses varying, setting aside and enforcing a Tomlin order, including the considerations the court will take into account when handling applications for each. Further guidance is provided on interpreting and applying the relevant provisions of the CPR; however, some courts and divisions impose very specific requirements for both drafting and approval, and for approaching the schedule and confidentiality issues. Accordingly, you must consider the particular rules and court guide provisions in the forum where your claim is proceeding when drawing up the Tomlin order...
Date [ date ] Parties [ name of Landlord ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Landlord) [ name of Tenant ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Tenant) [ [ name of Guarantor ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Guarantor) ] [ [ name of Mortgagee ] [ of OR incorporated in England and Wales (company registration number [ number ]) with its registered office at ] [ address ] (Mortgagee) ] Definitions Within this Deed, the terms below shall be interpreted as follows: [ Annual Rent • the annual sum reserved under the Lease; ] [ Insurance Rent • the Tenant’s share of the Landlord’s costs of insuring the Property (as set out in the Lease); ] Lease • the lease of the Property dated [ date ], entered into between (1) [ the Landlord OR [ name ...
I, [ name ], of [ address ], solemnly and sincerely state that: [ Matters to be verified, set out in numbered paragraphs ] I make this solemn statement in good conscience, believing it to be true, and pursuant to the provisions of the Statutory Declarations Act 1835. DECLARED at [ details ] this [ day ] day of [ month and year ] Before me ................................................................................ [ signature of the person before whom the declaration is made ] A [ commissioner for oaths OR [ solicitor OR [ insert other qualification ] ] authorised to administer oaths ]...
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