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
When forming a limited company, careful thought should be given to whether it ought to be public or private. The Companies Act 2006 ( CA 2006) adopts a 'think small first' approach, on the basis that private companies are smaller than public ones. As a result, CA 2006 generally applies simpler, basic requirements and procedures to private companies, and places additional, extensive requirements and procedures on public companies. The table below sets out some of the key differences in the requirements and procedures that apply to private and public (unlisted) limited companies......
For comprehensive guidance and full details on forming a public company limited by shares, refer to 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 public company limited by shares Decide whether the company will be bespoke on incorporation or instead acquired 'off the shelf'. If a bespoke company is chosen, continue with the remaining points and actions in this checklist accordingly. See also: Tailoring a shelf company limited by shares—checklist. N/ A Identify the initial shareholders (the subscribers). A single subscribing shareholder is acceptable and sufficient......
This Checklist identifies jurisdictions across the globe presently empowered to examine or demand notification of deals that sit under compulsory filing thresholds (not including sector-specific regimes, or the use of general antitrust (behavioural) provisions). For added information on filing thresholds, see the MJ merger grid—jurisdiction. Jurisdictions where competition authorities have the discretion to review transactions below thresholds Set out below is a compilation of jurisdictions in which competition authorities may scrutinise or require notice of transactions falling beneath mandatory notification thresholds (excluding sector-specific regimes, or the operation of general antitrust (behavioural) rules)......
STOP PRESS: The Financial Remedies Guide 2026, issued 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, replaces and supersedes the following: Statement on the efficient handling of financial remedy cases assigned to a High Court judge, whether sitting at the Royal Courts of Justice or in any other venue (1 February 2016) (the High Court judge level efficiency statement) 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) Financial Remedies Court Primary Principles document (11 January 2022) Notice from the Financial Remedies Court on...
Trustees Verify who the present charity trustees are. Examine historic appointment and retirement deeds to validate earlier changes to the board. Consider whether any current trustees have obvious conflicts of interest. Trust instrument Review the trust instrument and identify the powers it grants. Record any express limits on exercising those powers. Note whether any of the charity’s land is functional, designated, or held in specie. Land and leases Identify the charity’s property holdings and carry out the following checks: Confirm that title to all land is current, checking whether required deeds or transfers were executed after trustee changes, or reliance is placed on statutory vesting; verify proper execution of all documents. Confirm that appropriate restrictions have been entered on the title register. Confirm, so far as possible, that the land was duly authorised on acquisition, and review every lease where the charity is landlord or...
This Checklist outlines best practice for undertaking environmental, social, and governance due diligence, offering general direction on ESG reviews alongside specialised guidance for each ESG pillar. For wider ESG materials, see: ESG and sustainability collection. For environmental due diligence, consult the following Practice Notes: Environmental due diligence-asset purchase Environmental due diligence-share purchase Environmental due diligence-leases For broader due diligence guidance, see Practice Note: Due diligence-share and asset purchases. Introduction As national and international regulators release progressively stricter ESG guidance and public focus on ESG matters intensifies, the need for ESG due diligence on M& A targets continues to rise. A rigorous ESG review by an M& A buyer and its advisers can pinpoint, mitigate, and even avoid regulatory and reputational risks, while shaping deal valuation and structure. Strong ESG policies and practices may make a target more compelling by creating lasting value and...
Reviews In insolvency cases, a review occurs when the court returns to and considers an order it has previously made. This mechanism (across corporate and personal insolvency) permits the decision to be reconsidered either by the judge who issued it (see Official Receiver v Bathurst) or also by a different judge (see Re W & A Glaser Limited). Both personal and corporate insolvency courts hold power to review, rescind, or vary their own orders (section 375 of the Insolvency Act 1986 ( IA 1986) and the Insolvency ( England and Wales) Rules 2016 ( IR 2016), SI 2016/1024, r 12.59(1)). A review should not be treated as a substitute for an appeal, and the court will deploy its discretion with particular caution when asked to formally revisit an order. For more detail, see Practice Note: Reviews of insolvency...
This guidance sits within the Procurement Act 2023 framework and focuses on public procurement under the Procurement Act 2023 ( PA 2023). New in-scope procurements must run under PA 2023. For background on the regime, see Practice Note: Introduction to the Procurement Act 2023- PA 2023. Procurements launched before PA 2023 began on 24 February 2025 remain under the prior legislation-the Public Contracts Regulations 2015, SI 2015/102; the Utilities Contracts Regulations 2016, SI 2016/274; the Concession Contracts Regulations 2016, SI 2016/273; and the Defence and Security Public Contracts Regulations 2011, SI 2011/1848. For headline differences from the old regime, see Checklist: Procurement Act 2023-key changes. For transitional details, see Practice Note: Procurement Act 2023 transitional and saving arrangements- PA 2023. Special regime contracts This Checklist gives a quick reference to the core features of special regime contracts under PA 2023. PA 2023, s 10(6) defines a...
SM& CR—timeline This Practice Note charts policy and guidance progress and change on the SM& CR, along with key milestone dates, from 1 January 2025 onwards. For more detailed information and Lexis PSL material on the SM& CR, see SM& CR and approved persons regime—overview. For a concise primer on the SM& CR, with additional notes on forthcoming developments, see Practice Note: SM& CR—one minute guide. For all activity before 1 January 2025, see: SM& CR—policy development and key dates—to 31 December 2024 [ Archived]. For culture, diversity and inclusion ( D& I), and non-financial misconduct related updates, see: Culture and social governance in financial services—timeline. Date Source Documents Description 23 January 2026 FCA FCA invites views on additional rules for cryptoasset firms CP26/4: Application of FCA Handbook for regulated cryptoasset activities – part 2 CP26/4: Application of FCA Handbook for regulated...
This table sets out, in reverse date order, significant cases in the evolution of the Ramsay anti-avoidance principle. It does not attempt to cover every decision touching on the principle. The focus is on the present: more recent rulings from lower courts are likelier to appear, as they indicate the latest judicial approach... For an overview of the Ramsay principle, see Practice Note: Ramsay as a guide to statutory construction. For comprehensive tracking of current (and recently completed) tax litigation, see the: Tax—cases tracker... Case name and citation Who won in the highest court? Facts in a nutshell Quote(s) from the judgment Comment The Tower One St George Wharf Limited [2025] EWCA Civ 1588 (judgment date 10 December 2025) — The government (in the Court of Appeal) — SDLT step-up scheme — the court held that ‘claim’ should be interpreted...
This Checklist highlights the key matters to consider when preparing new Research and Development ( R& D) agreements, or revising existing R& D agreements, to determine whether they fall within the block exemption available under the Competition Act 1998 ( Research and Development Agreements Block Exemption) Order 2022 ( UK R& D BEO), SI 2022/1271. It is not a full guide to the UK R& D BEO, but is intended for situations where a commercial lawyer wishes to be confident that an R& D agreement sits within the UK R& D BEO and aligns with the CMA Guidance on Horizontal Agreements (2023 Horizontal Guidance). Introduction to the UK R& D BEO Any agreement that influences trade or restricts competition in the UK may fall under the prohibition on anti-competitive agreements in Chapter I of the Competition Act 1998 ( CA 1998) (the Chapter I...
Using this Checklist This Checklist concentrates on the IP elements of R& D agreements and pinpoints the principal provisions commonly found in such contracts. It serves as a list of points to address when drafting, reviewing or negotiating these agreements. It also touches on central competition law issues. Nevertheless, a case-by-case analysis is required to confirm that an agreement’s IP clauses align with competition rules, notably the bans on anti-competitive agreements in Article 101(1) of the Treaty on the Functioning of the European Union ( TFEU) and Chapter I of the Competition Act 1998 ( CA 1998). On 1 June 2023, the European Commission adopted the EU Research & Developments Block Exemption, Commission Regulation ( EU) 2023/1066 ( EU R& D BER), together with the related Horizontal Guidelines. The EU R& D BER took effect on 1 July 2023 and will lapse on 30 June 2035. On 5...
This Checklist This Checklist summarises Consumer Duty priority themes identified by the Financial Conduct Authority ( FCA). See The FCA Consumer Duty—timeline for the full developments timeline......
This Checklist sets out an overview of the principal legal and practical matters that may call for attention during a transfer of undertakings carried out under SI No 131/2003 European Communities ( Protection of Employees on Transfer of Undertakings) Regulations 2003 ( Ireland) ( SI 131/2003 ( IRL) ( TUPE Regulations 2003 ( IRL)), as amended by the Workplace Relations Act 2015 ( Ireland) ( WRA 2015 ( IRL)). Information and consultation Both the transferor and the transferee alike bear statutory duties in relation to information and consultation before, during, and after the transfer process. The scope of those statutory responsibilities is ultimately fixed by reference to the date of transfer. Up to the transfer date, the transferor remains liable for all statutory obligations concerning information and consultation on the transfer process and the potential impact on employees’ rights linked to their contract of...
This Checklist This Checklist summarises the core elements of Scottish due diligence where a change of use may have triggered a breach of planning control. It describes how to confirm whether the current use is sanctioned by planning permission, permitted development rights, the Use Classes Order or a lawful use certificate, and if that permission extends to the entire premises. It also covers enforcement, breach of condition and stop notices, the statutory limitation periods and immunity from action under the Town and Country Planning ( Scotland) Act 1997 ( TCP( S) A 1997), and indicates what the due diligence should contain. This forms part of the wider planning guidance for Scotland; see: Planning for property lawyers in Scotland-collection. By virtue of TCP( S) A 1997, s 28, any material change in the use of buildings or other land requires planning...
Physical extent, boundaries, rights, etc Does the sale plan align with: the material set out in the title deeds, and the on-the-ground boundaries indicated by fences, walls, ditches, rivers, streams, etc, or as revealed by the seller in replies to enquiries? See Practice Note: Property boundaries for further guidance. Will a new boundary arise from the sale? Has it been clearly set out on site, and do the plans show its position accurately? Who must put it in place and/or look after it thereafter? Is indemnity insurance for defective title necessary? If so, who will arrange it and meet the cost? See: Defective title insurance—checklist for further guidance. Do mines and minerals form part of what is being...
Introduction This checklist flags issues to consider when acting for the seller of agricultural land, including the Basic Payment Scheme (so far as it still applies in Wales), taxation, capital allowances and VAT. For several items identified, the main aim is to provide a thorough contract, title and information pack to the buyer as early as possible, limiting the chance of later ‘price-chipping’ if unexpected ‘blemishes’ emerge during the process. Physical extent, boundaries, rights, etc Does the sale plan align with: the evidence in the title deeds; and the actual boundaries of the property as indicated by fences, walls, ditches, rivers, streams, etc, or as disclosed by the seller in replies to enquiries? For further guidance, see Practice Note: Property...
Automatic Exchange of Information ( AEOI) is the worldwide benchmark for routinely transmitting taxpayers’ financial details between jurisdictions to deter tax evasion. A trust resident in the UK is generally brought within the UK AEOI framework through the International Tax Compliance Regulations 2015 ( SI 2015/878), as amended (the ‘ ITC Regulations’). The ITC Regulations give domestic effect to the UK’s AEOI commitments under the Common Reporting Standard ( CRS) and the UK‑ US FATCA Agreement ( FATCA). Refer to Practice Notes: Automatic exchange of information-outline; Automatic exchange of information for UK trustees-key obligations; and FATCA and UK Trusts. HMRC’s guidance appears in the International Exchange of Information Manual ( IEIM400000). This Checklist summarises the principal matters trustees must consider under the UK AEOI regime. Scope and Threshold Question: Does AEOI Apply? Has the trust’s UK tax residence position been...
Before commencing the arbitration Check any limitation deadlines or contractual time bars under the substantive law governing the dispute ( Article 36.1). Identify the claims you plan to bring in HKIAC proceedings and confirm they fall within the arbitration agreement providing for HKIAC administration ( Article 1.1). Decide if urgent protection is required before the tribunal is in place and/or whether interim relief should be sought after constitution, including measures to preserve assets or preserve evidence ( Article 23; Schedule 4). Fix the tribunal size; if no accord is reached pre-arbitration or within 30 days of the respondent’s receipt of the Notice of Arbitration, HKIAC will determine this having regard to the case’s circumstances ( Article 6.1). Prepare nominations for tribunal appointment; note a proposed arbitrator must sign a declaration of availability, impartiality and...
Legal issues This checklist sets out the main terms and matters to bear in mind when preparing and negotiating indemnity provisions in commercial (business-to-business) contracts. For model wording with drafting notes, see Precedent: Indemnity clause-commercial contracts. For more on indemnities, consult the following Practice Notes: Indemnities in commercial contracts Guarantees and indemnities-general contract For a practical guide to reviewing an indemnity clause in B2B agreements, see Practice Note: How to review an indemnity clause. General comments What to watch out for Is an indemnity appropriate? An indemnity is a contractual promise by one party to reimburse the other for specified loss or damage or, in some instances, to relieve them from liability. Unlike a guarantee, it imposes a primary obligation that may not rely on a third party’s default. Assess if an indemnity is the right mechanism or whether a guarantee is preferable, for example where a parent...
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 ]...