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LIFE SCIENCES

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

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CONSTRUCTION

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

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PROPERTY

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

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CHECKLISTS

ARCHIVED: This Checklist is archived and is not being maintained. From 18 September 2023, the National Crime Agency ( NCA) introduced a new SAR online portal, replacing the version described in this Checklist. For details of the current SAR reporting portal, see Practice Note: How to submit a SAR using the NCA SAR Portal. SAR Online is the NCA’s secure web-based platform for submitting suspicious activity reports ( SARs) to the NCA, and it is the NCA’s preferred channel for receipt. This Checklist condensed key guidance on using the system and acted as a quick reference for submitting SARs via the now replaced SAR Online portal. For further information, see Practice Note: Authorised disclosure, protected disclosure and appropriate consent— Suspicious Activity Reports ( SARs). SAR Online—key guidance The NCA’s UK Financial Intelligence Unit ( UKFIU) has published user guidance for SAR Online: SAR Online User...

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CHECKLISTS

Has the correct application form been used? If an application is submitted on the wrong form, or without the requisite details, it will be invalid and the local planning authority ( LPA) may decline to validate it. The determination period only starts from the date the application is validated. The application must be submitted by one of the following routes: an online submission via the Planning Portal (advised) the national standard application form (1APP), completed and filed online or as a PDF a paper/ PDF form downloaded from the Planning Portal ‘ Paper Form Chooser’ (or, where available, from the relevant LPA’s website) and sent by post or email......

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CHECKLISTS

This Checklist This Checklist sets out the key questions for landlords, tenants and subtenants when a tenant grants a sublease of commercial premises in Scotland. Matters to consider include: restrictions on subletting financial strength of the subtenant form of landlord consent requirements for landlord consent form of sublease irritancy protection agreements In this Checklist, the parties are referred to as landlord, principal tenant and subtenant. Although a sublease is granted by a party that is itself a tenant (the principal tenant), it is regulated by the same principles that apply to leases generally. The sublease may cover the whole of the premises under the principal lease, or only a part, and it may run for all or part of the remaining term of the principal lease. The principal tenant must continue to fulfil its duties under the head lease, but these obligations are typically flowed down to the subtenant through the...

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CHECKLISTS

Checklist This Checklist summarises practical measures a sub-contractor should consider if the main contractor on a construction project becomes insolvent during the course of the works. It assumes the sub-contractor is engaged on written terms by a main contractor for a defined sub-contract package, and that the main contractor has been making payments directly (i.e. there is no project bank account, escrow account, or alternative payment mechanism). For advice on identifying early signs of solvency concerns and protecting the sub-contractor’s position from the outset, see Practice Note: Construction insolvency—how to spot problems and how to protect yourself—sub-contractors. Where the main contractor on a construction scheme has gone insolvent, the sub-contractor should respond promptly and evaluate every practical and legal step available to safeguard its position. The actions a sub-contractor should contemplate are outlined below......

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CHECKLISTS

Use this Checklist when preparing a sub‑contract agreement for a main contractor, or prime contractor, that engages a sub‑contractor to fulfil particular obligations under the main or prime contract. It is appropriate when drafting a sub‑contract for a commercial transaction involving the supply of goods and services, or other generic commercial activities, but it is not intended for a construction sub‑contract, nor for sub‑contracting consultancy services. For an illustrative agreement suitable for a sub‑contract covering a commercial transaction for the supply of goods and services, or comparable generic commercial activities, see Precedent: Sub‑contract agreement. For a more detailed analysis of the legal and practical considerations when entering into a sub‑contract, or when granting permission to sub‑contract, see Practice Note: Subcontracting. Initial matters Verify that the parties named within the contract itself are correct, accurate throughout and complete......

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CHECKLISTS

ARCHIVED : This Checklist has been archived and is not maintained . STOP PRESS: From 1 November 2024, the UK’s new securitisation framework took effect, annulling and supplanting the onshored EU legislative regime. Although the UK rules broadly preserve the substance of the prior onshored EU approach, they part company in several notable respects, including scope, risk retention, transparency, due diligence and STS designation. For a side-by-side of the STS criteria under both frameworks, see Practice Note: UK and EU securitisation regimes—comparison. On 17 June 2025, the European Commission issued its long-anticipated review of the EU Securitisation Framework, together with an extensive legislative package proposing amendments to the EU Securitisation Regulation ( Regulation ( EU) 2017/2402), the EU Capital Requirements Regulation ( Regulation ( EU) No 575/2013), the EU Solvency II Delegated Regulation ( Commission Delegated Regulation ( EU) 2015/35) and the EU...

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CHECKLISTS

This note sets out a side-by-side timetable, drawing a distinction between takeovers pursued through a takeover offer and those implemented via a transfer scheme of arrangement. For commentary on the options available when structuring an offer, together with a comparison of takeovers effected by the scheme of arrangement against takeovers made by contractual offer, see Practice Note: Structuring a takeover—offers vs schemes of arrangement. For fuller timetables for a takeover structured by way of offer or scheme, see: Timetable—offer and Timetable—scheme. References to Rules denote the Rules of the Code......

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CHECKLISTS

Here is a sample of how a development project might be typically organised...

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CHECKLISTS

This Checklist outlines the key matters a tenant should weigh up if the landlord becomes insolvent. A tenant must continue to fulfil its obligations under the lease, and should promptly contact the insolvency practitioner, as the tenant will need the information set out below. Swift contact is important because guidance on payments and other particulars will be required. Who should rent be paid to? Rent must still be paid in line with the lease. Where the landlord is in administration, liquidation or bankruptcy, or a receiver has been appointed over the property, payment should be made to the administrator, liquidator, trustee in bankruptcy or receiver, as applicable. Under a company voluntary arrangement ( CVA), rent may instead be due to the CVA supervisor, subject to the CVA terms. The insolvency practitioner will usually serve notice on the tenant confirming where rent must be sent. Is the...

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CHECKLISTS

The European Commission ( Commission) examines claims of anti-competitive conduct by businesses affecting more than one EU member state; for instance, cartel price-fixing or assertions that a major multinational has pursued predatory pricing strategies. The successive phases of a Commission antitrust inquiry are illustrated clearly in the flowchart below. For further details, refer to EU investigations—steps in investigations for more information......

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CHECKLISTS

This Checklist describes the principal issues to bear in mind when preparing or checking step‑in (also ‘substitution’) provisions contained in a collateral warranty. See Practice Note: Step‑in rights in a collateral warranty. For ease, the terms ‘contractor’, ‘beneficiary’ and ‘building contract’ are used throughout; however, the same principles apply equally to a collateral warranty given by a sub‑contractor or consultant pursuant to its sub‑contract or appointment. It highlights the key considerations for such drafting and review when doing so effectively. Which collateral warranties typically have step-in rights? Step‑in rights are a standard feature of the following categories of warranty: collateral warranty provided by a contractor to a funder or, in some circumstances, to a forward purchaser collateral warranty provided by a sub‑contractor or consultant to the employer collateral warranty provided by a sub‑contractor or consultant to a funder Is this the only...

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CHECKLISTS

A statutory demand A statutory demand is an official written notice requiring payment of a debt. See Practice Note: What is a statutory demand? Do not disregard a statutory demand. It might lead to the court winding up your company, or to you being made bankrupt......

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CHECKLISTS

ARCHIVED: This Checklist has been archived and is no longer being updated. For details of offences that can be committed under the Investigatory Powers Act 2016, see: Offences under the Investigatory Powers Act 2016—checklist. 27 June 2018: offences concerning unlawful interception and disclosure of communications data under RIPA 2000, ss 1 and 19, were repealed and replaced by the offences of unlawful interception and making unauthorised disclosures under IPA 2016, ss 3 and 59. 27 December 2018: RIPA 2000, s 11, was repealed. For information on the background and scope of IPA 2016, see Practice Note: The regulation of intelligence gathering—an introductory guide. Although offences under these provisions can no longer be committed, prosecutions may still be brought where the offence predates repeal (27 June 2016 for sections 1 and 19 offences, 27 December 2018 for section 11 offences). Where unlawful...

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CHECKLISTS

When does a section 75 debt arise? An s 75 liability crystallises in respect of an occupational pension scheme that is underfunded on a buy-out basis and: an employment-cessation event happens for a relevant participating employer within a multi-employer scheme an insolvency event occurs in relation to a participating employer of the scheme, or the scheme formally goes into winding up In a multi-employer scheme, an employer’s s 75 debt is its allocated share of the scheme deficit, appropriately assessed on a buy-out basis. As an alternative to immediately paying the s 75 debt in full, an employer may enter into a deferred debt arrangement, an apportionment arrangement, or a withdrawal...

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CHECKLISTS

Contracting-out provisions Most claims that can be taken to the employment tribunal stem from jurisdiction granted by statutory provisions. Each such statutory scheme contains a term that prevents the parties (or would-be parties) to an employment tribunal claim from entering an agreement that purports to settle the claim and, in doing so, purports to exclude the tribunal's jurisdiction to determine the dispute. These terms are commonly described as 'contracting-out provisions', and they appear in broadly similar form across a wide range of employment legislation, eg the Employment Rights Act 1996 ( ERA 1996), Trade Union and Labour Relations ( Consolidation) Act 1992 ( TULR( C) A 1992) and the Equality Act 2010 ( Eq A 2010). They are intended to safeguard claimants (and potential claimants) by stopping them from signing away the right to bring or pursue a claim unless...

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CHECKLISTS

Contracting-out provisions Most claims pursued in the employment tribunal arise from a jurisdiction conferred by statutory measures. Each such statutory scheme typically includes a clause preventing the parties (or prospective parties) to a tribunal dispute from concluding an arrangement that purports to settle the claim and, by doing so, purports to displace the employment tribunal’s authority to decide the dispute. These clauses are commonly known as 'contracting-out provisions', and they appear, in broadly similar terms, across a wide range of employment legislation, eg the Employment Rights Act 1996 ( ERA 1996), the Trade Union and Labour Relations ( Consolidation) Act 1992 ( TULR( C) A 1992) and the Equality Act 2010 ( Eq A 2010). The aim of these provisions is to protect claimants (or potential claimants) by ensuring they do not sign away the right to commence or continue a claim without...

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CHECKLISTS

The single tier State Pension (on and from 6 April 2016) On 6 April 2016, the Basic State Pension was overhauled and replaced by a single-tier, flat-rate pension, merging the Basic State Pension with the Second State Pension. From that date, men and women alike must have 35 qualifying years of National Insurance contributions to receive the full flat-rate amount. Marital status makes no difference to the level paid. Tax year Amount (per week) 2026/2027 £241.30 2025/2026 £230.25 2024/2025 £221.20 2023/2024 £203.85 2022/2023 £185.15 2021/2022 £179.60 2020/2021 £175.20 2019/2020 £168.60 2018/2019 £164.35 2017/2018 £159.55 2016/2017 £155.65 The Basic State Pension (before 6 April 2016) Before 6 April 2016, the Basic State Pension comprised the Basic State Pension and the Second State Pension. There was a third, minor, component known as the graduated pension that depended on graduated National Insurance contributions paid by employees while the graduated scheme ran from 1961 to 1975. The Basic State Pension is a...

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CHECKLISTS

This Checklist summarises guidance on pursuing a ‘ UK GDPR claim’. It draws on the United Kingdom General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR), together with the Data Protection Act 2018 ( DPA 2018) legislation. Where the EU has jurisdiction, proceedings are governed by the EU’s General Data Protection Regulation, Regulation ( EU) 2016/679 ( EU GDPR). UK data protection rules—most notably Assimilated Regulation ( EU) 2016/679 ( UK GDPR)—originate to a large extent from EEA data protection frameworks and, as a result, generally rest on comparable principles, although some provisions differ slightly in detail. In the UK, ‘assimilated law’ denotes retained EU law ( REUL) that continues to have effect after the end of 2023 and remains in force, for example the UK GDPR legislation. Re-labelling REUL (and related terminology) as assimilated law signals a shift in its status and...

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CHECKLISTS

This Checklist This Checklist outlines the key stages at the outset of arbitration proceedings governed by the 2021 International Chamber of Commerce ( ICC) Rules of Arbitration ( ICC Rules). For background on the 2021 ICC Rules, consult Practice Note: ICC (2021)—introduction to the ICC and arbitration under the ICC Rules......

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CHECKLISTS

CORONAVIRUS ( COVID-19) This Checklist is archived and no longer being actively maintained. Numerous arbitral organisations have responded to the coronavirus pandemic by issuing practical guidance and/or making adjustments to their standard procedures and working practices. For further details on how this material and associated arbitration proceedings could be affected, see Practice Note: Arbitral organisations and coronavirus ( COVID-19)—practical impact [ Archived] [ Archived] [ Archived]. For additional information, see: Coronavirus ( COVID-19) and arbitration—overview. For direct links to guidance on the 2021 ICC Rules (effective 1 January 2021) and the 2012 ICC Rules, see: ICC arbitration—overview......

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Popular documents

When evaluating a general damages claim, the practitioner ought initially to refer to the Judicial College Guidelines (JCG)...

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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...

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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 ...

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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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