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
STOP PRESS relating to new MTT and DTT draft legislation : Section 50 and Schedule 8 of the Finance Act 2026 revise multiple elements of the MTT and DTT rules. Notably, the draft law folds in the OECD’s Administrative Guidance ( January 2025), which curbs how far pre-entry deferred tax assets and liabilities—stemming from government-granted tax incentives—may be recognised when calculating a group member’s effective tax rate. That element is to be regarded as effective for accounting periods ending on or after 21 July 2025. Most remaining measures apply to periods beginning on or after 31 December 2025, albeit certain provisions may commence earlier at the option of impacted taxpayers. For further detail, see: News Analysis: Budget 2025— Tax analysis— International. These commencement dates apply to the specified measures under the MTT and DTT regimes as set out in the draft...
It is important to establish whether or not the land is or may be contaminated: to comply with the Law Society’s practice note on contaminated land—see Practice Note: Land contamination— Law Society practice note on contaminated land; because it could present a risk to human health; and because a buyer may face a statutory requirement to remediate under the Environmental Protection Act 1990, Pt IIA. While Pt IIA is intended as a last-resort mechanism (with remediation far more often secured through planning conditions when contaminated land is brought forward for (re)development), if liability under Pt IIA is imposed the cost of necessary clean-up can be very significant. The Law Society’s practice note advises that, when acting for a buyer, mortgagee or tenant, a solicitor should—unless instructed otherwise—undertake a CON 29 ‘ Enquiries of local authority’ and an LLC1 ‘...
Individuals or entities that may be entered onto a PSC register: registrable individuals holding significant control registrable relevant legal entities subject to their own disclosure requirements: all UK companies limited by shares or by guarantee (including community interest companies ( CICs)) and dormant companies UK unlimited companies UK limited liability partnerships ( LLPs) unregistered companies subject to the Unregistered Companies Regulations 2009 (including some Royal Chartered bodies, such as City of London Livery Companies, Guilds and other societies and professional bodies) UK Societas......
Arrangements under section 110 of the Insolvency Act 1986 ( IA 1986) (section 110 arrangements) Section 110 arrangements are frequently adopted to separate a company’s business and/or assets into distinct undertakings. They are available only within a voluntary liquidation and, with appropriate planning, can be notably tax‑efficient. In essence, a section 110 arrangement is a three‑party framework between: the company in liquidation (the Transferor), acting through its liquidator (the Liquidator) a newly incorporated entity acquiring some or all of that business and/or assets (the Transferee) the Transferor’s shareholders Typically, the Transferor’s shareholders receive, via the Liquidator, an in specie distribution in the winding up comprising shares in the Transferee, which make up all or part of the consideration for the transfer. Business or asset splits can be effected and, accordingly, there may be more than one Transferee. For further detail, see Practice Note:...
A note on terminology The Law of Property Act 1925 ( LPA 1925) allows a mortgagee holding a legal mortgage to appoint an LPA receiver: when the mortgage monies fall due; and after issuing a demand for payment under the mortgage terms. This power may instead (and more commonly will) derive from the terms of the charge. In either case, the appointee may be described as a fixed charge receiver (in the latter scenario they are not an LPA receiver, though in practice they are still frequently referred to by that label). Checklist and timescale In practice, many LPA/fixed charge receiver appointments are made at speed, yet it remains essential not to overlook the fundamental requirements for a valid appointment. This Checklist outlines the matters an LPA/fixed charge receiver should verify before and after appointment, how to obtain the appointment, and the...
A deferred prosecution agreement ( DPA) A DPA is a negotiated agreement between an organisation and a designated prosecutor, allowing the latter to defer a prosecution by staying an indictment on set conditions. Whilst the DPA remains in force, no proceedings relating to the covered matters may be brought against the organisation. Consequently, a company can continue operating without a protracted criminal investigation or an expensive prosecution hanging over it. For detailed information on DPAs, see the Practice Notes below: Deferred prosecution agreements DPA process Terms and content of a DPA DPAs in practice DPAs are only available to organisations for the offences specified in the Crime and Courts Act 2013, Schedule 17 ( CCA 2013). The checklist below lists the offences for which a DPA may be entered into, covering both common law and statutory offences. In addition, any offence that is ancillary to those offences is eligible for...
This Checklist Land title documentation—registered or otherwise—may indicate that the current owner, or a prior proprietor, has agreed covenants affecting all or part of the land. These obligations can be positive (for example, to keep a boundary fence in repair) or restrictive (for example, a promise not to build alongside a boundary). While covenants invariably bind the original contracting parties, the law treats positive and restrictive covenants differently when assessing their impact on successors in title to those parties. This Checklist is intended for use during due diligence where a property is burdened by and/or enjoys the benefit of one or more restrictive covenants. Such covenants may be: imposed for the landowner’s own benefit; they are personal and enforceable only by the original parties unless expressly assigned to a third party part of a scheme, such as a building scheme, where mutual...
The Investigatory Powers Act 2016 ( IPA 2016) reshapes the statutory regime governing covert surveillance conducted by public authorities, a regime largely, but not entirely, previously contained in the Regulation of Investigatory Powers Act 2000 ( RIPA 2000). This Checklist carefully sets out those public authorities that hold the power to apply for authorisation to obtain communications data under IPA 2016, Pt 3, preserving the established focus and scope throughout. Authorisations to secure communications data may only be granted where defined conditions are satisfied, by the Investigatory Powers Commissioner under IPA 2016, s 60A, by designated senior officers under IPA 2016, s 61, or by designated senior officers in urgent circumstances under IPA 2016, s 61A. In operational practice, the Office for Communications Data Authorisations carries out this function on the Commissioner’s behalf. The table below specifies which public authorities may apply to access...
This Procedural Guide Sets out the process under the Debtors Act 1869 ( DA 1869), the Family Procedure Rules 2010 ( FPR 2010), SI 2010/2955, Pt 33, and the Administration of Justice Act 1970 ( AJA 1970) for applying for a judgment summons compelling a debtor to attend court where the debtor has, or has had since the date of the order or judgment, the means to meet the defaulted amount, yet refuses or neglects to do so. It provides guidance on eligibility to apply, the criminal standard of proof and evidential requirements, and the debtor’s committal. A judgment summons is a summons that requires a debtor to appear before the court. If it is proved to the court’s satisfaction that the debtor has, or has had since the order or judgment, the means to pay the sum in default, and has refused or...
Note: As of 1 October 2023, the CPR has been updated to broaden the scope of fixed recoverable costs. These changes apply where the cause of action arises on or after 1 October 2023 (typically the accident date). For the version of Part 45 that applied before 1 October 2023, see: Can more than fixed costs be recovered? London weighting A 12.5% uplift to fixed costs applies if the claimant resides or works, and the instructed solicitor practises, within one of the London areas identified in CPR 45. Other circumstances For direction on other situations where recovery beyond fixed costs may be possible, see Practice Note: Fixed costs in road traffic accident claims. Children Distinct fixed costs apply to infant approval hearings, known as Type C fixed costs. The schedule for fixed costs under the Pre- Action Protocol for Low Value Personal Injury Claims in Road Traffic...
This flowchart outlines the steps in a disciplinary process addressing suspected employee misconduct: from fact-finding into the allegation(s), through holding a disciplinary meeting and deciding any sanction, to administering an appeal. Click below to open or print the full-size PDF version: Note 1—dealing with an allegation of misconduct When assessing whether the matter amounts to possible misconduct, it may also be necessary to examine the employee’s contract, the employer’s staff handbook and any other applicable policies or procedures beyond the disciplinary/dismissal procedure, for example an equality/equal opportunities policy or an expenses policy. Remember that a situation that initially appears to be misconduct could instead be a performance or capability issue. See Practice Note: Managing conduct— Dealing with conduct issues. Where a conduct issue arises, the first step is to investigate promptly and without undue delay to establish the facts of the case. Note 2—using...
During a criminal inquiry, HMRC may apply to a magistrate for a warrant authorising entry to and search of premises. It may also seize and retain any material specified in the warrant. The extent of HMRC’s powers to investigate criminal offences, and the situations in which they may be exercised, is outlined in Practice Note: HMRC criminal investigations and dawn raids. This Checklist offers a practical set of dos and don’ts for a dawn raid. It can act as a handy reference for clients who might face a dawn raid. The procedures described should be communicated to staff in advance. As the client will not know about the raid before it happens, this may be problematic. It may be possible to circulate the guide on a ‘just in case’ basis. It is also sensible to train key staff on how to manage and respond to a dawn...
This Checklist outlines the principal points to weigh up when drafting term and termination provisions in a commercial contract for use by the parties. For additional guidance on the duration and ending of commercial contracts generally, in practice, see: Practice Note: Drafting term and termination clauses—commercial contracts and Contract termination—overview General drafting points The common law has developed a series of principles concerning contract length and termination. For instance, where a contract says nothing about duration, a court may imply a right to end it on reasonable notice. In some situations, parties may also end a contract for repudiatory breach. Nevertheless, it is usually better to set out express terms on duration and termination to give the parties certainty, rather than depending on common law. If a contract lacks express termination rights, it may be uncertain whether a given breach allows the...
For further details on the documents outlined below, please refer to Practice Note: Issuing debt securities—key documentation. Appointment of the arranger The issuer ( Issuer) designates an arranger ( Arranger) to set up the programme. The Arranger may additionally serve as a dealer or manager for later note issues under the programme. Responsibility — Issuer and Arranger. Appointment of the dealers The dealer(s) ( Dealers) will enter into a dealer agreement with the Issuer and the Arranger. For a syndicated issue, the Dealers and the Issuer may also sign a subscription agreement. New dealers may be added to the programme after launch via a dealer accession letter. Responsibility — Dealers, Arranger and the Issuer. Appointment of the agents The Issuer will appoint agents to act on its behalf for the programme. These may include a fiscal agent ( Fiscal Agent) or a trustee (appointed by the Issuer to represent the interests of the...
Checklist This Checklist is chiefly intended primarily for customers (licencees). It provides an overview of the key terms commonly and usually found in a supplier agreement to licence ‘on‑premise’ software installed on the customer’s own infrastructure. For issues related to the licensing and deployment of software as a service ( Saa S), see Practice Note: Cloud computing—introduction and Precedent: Software as a service ( Saa S) agreement—pro-customer, accordingly. For further reading and template documents relating to this Checklist, see the following: Practice Note: Key issues in software licence agreements Practice Note: Warranties and indemnities in software licence agreements Precedent: Software licence—pro-customer Precedent: Software licence—pro-supplier Negotiation guide— IT contracts Further information Notes (if any) Grant and scope of licence Is the software described clearly and adequately? The customer should be clear about what it is contracting for. There may also be...
This checklist sets out the pre-completion searches a buyer, tenant or mortgagee should carry out, indicating when searches are required, timing requirements, and the priority periods given by each search. It is not exhaustive, and extra searches may also be needed depending on the nature of the transaction. For details of how to make each search and how to deal with any adverse entries revealed, see Practice Note: Pre-completion searches. Search When is it necessary? Timing Priority period Official search with priority Use form OS1 to obtain an official search with priority for the whole of a......
This checklist outlines the essential documents needed at the principal stages of the project lifecycle: Project set up Project planning Project delivery Project closure It can be used alongside Checklist: Project management: key roles and governance—checklist. Project set up A project is regarded as ‘set up’ when a requirement or change has been identified. Permission to commence is provided via a mandate from a suitable senior figure in the organisation, usually the budget-holder who will finance the project. Project mandate the initial business case/justification for the project the purpose of the project how the outputs will be used the budget timescales for the work At this point a management team is formed, often as a project board or steering group, with a lead executive or sponsor appointed. A project manager and/or project support may also be named to handle...
This Checklist This checklist reviews the procedural and related issues the tribunal is expected to address at a preliminary meeting in arbitration, whether the process is ad hoc or under an arbitral institution. Matters typically cover jurisdictional objections, applications for interim measures or the trial of preliminary points, setting schedules for the progress of elements of the reference, and organising how all the evidence will be exchanged and presented. Whatever the forum—ad hoc or institutional—and whichever institutional rules govern, the tribunal will usually convene a preliminary meeting soon after it is formed. The parties themselves (rather than their advisers) are generally not obliged to attend this session, although it is advantageous if they do, as they will meet the tribunal and confront the opposing team at an early juncture. In international cases, it may also be one of the few chances for everyone...
This Checklist sets out the particulars that a tenant or landlord must provide when applying to the First-tier Tribunal ( Property Chamber) ( FTT) under the Tribunal Procedure ( First-tier Tribunal) ( Property Chamber) Rules (the Property Chamber Rules), SI 2013/1169. It specifically outlines the prescribed information required where the application relates to the right to enfranchise or obtain a lease extension of a property under the Leasehold Reform Act 1967 ( LRA 1967), and the specific documents to accompany such claims. Details needed solely for applications brought under different statutes are excluded. Rule 8 permits the tribunal to waive or ease compliance with the Property Chamber Rules, practice directions or tribunal directions, where proportionate in the circumstances, where it is content that the particulars and documents supplied with an application are adequate for determining it, and that no party has suffered, or is likely to...
FORTHCOMING CHANGE: On 11 March 2024, HM Treasury opened a consultation examining the effectiveness of the Money Laundering, Terrorist Financing and Transfer of Funds ( Information on the Payer) Regulations 2017 ( SI 2017/692), which impose duties on a range of businesses to identify and prevent money laundering and terrorist financing. The government published its response on 17 July 2025, followed on 2 September 2025 by a draft statutory instrument and an accompanying policy note. The draft SI proposes a de minimis exemption from the requirement to register with the Trust Registration Service where, among other conditions, a trust with no UK tax liability also satisfies all of the following: it holds no interest in UK land; it holds no assets of significant value exceeding £2,000; it has not, since creation, held property with a cumulative value above £10,000; and its...
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 ]...