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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

Achieving a meaningful induction Most organisations operate a regimented yet, to be candid, shallow onboarding for new hires. Largely, HR procedures dictate it, ticking off essential policy requirements — security, health and safety, and internal control frameworks. Beyond that, the general counsel ( GC) ought to make sure you’re introduced to pivotal people across your team and the wider company in a considered, organised manner. Still, much of this serves more to alert colleagues that someone has arrived than to genuinely support the newcomer. In essence, the process often prioritises protocol and optics over substance and genuine support for the new hire initially. The task, therefore, is to turn the induction window into something valuable. It’s an opportunity the new joiner should shape proactively to serve their interests early on......

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CHECKLISTS

This checklist outlines the three principal hurdles for a new general counsel during the first 100 days in the role, from the outset. Typical challenge Response option Desired outcome The team you have inherited For a GC, the initial priority is to evaluate the legal function’s capabilities and gaps within the team. The most effective route is a round of one‑to‑one meetings, and, crucially, frank input from colleagues across the business. There is every chance of success and every prospect of failure at this juncture, as so much depends on the calibre of the assessment made at this stage. This is equally the moment for the GC to set leadership expectations, stating clearly and unambiguously how roles and behaviours should be understood and enacted. The aim is to rally the team behind a collective effort and to establish the tone and the...

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CHECKLISTS

When considering an arbitration, you should consider: how the dispute will be financed and managed overall can the client realistically cover your professional fees together with the arbitration expenses? could another party or source be prepared to pick up the entire bill? is any relevant insurance already in place and available? would after-the-event insurance cover be an appropriate option? might your firm accept a conditional fee arrangement, a damages-based agreement, or some other funding structure? See Funding Arrangements— Overview (note: this link is not arbitration-specific) is the client open to exploring third-party funding? ......

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CHECKLISTS

ARCHIVED: This Practice Note has been archived and is no longer maintained. On 20 December 2017, the European Commission set out plans to reform the prudential regime for investment firms across the European Union, with the aim of delivering a framework that is more proportionate and more sensitive to risk. Those proposals ultimately resulted in the Investment Firms Regulation ( EU) 2019/2033 ( EU IFR) and the Investment Firms Directive ( EU) 2019/2034 ( EU IFD). As the EU regime only started to apply from 26 June 2021 (ie after the end of the implementation period that followed the UK’s withdrawal from the EU), it therefore did not automatically take effect in the UK. In June 2020, HM Treasury outlined, via the Financial Services Bill, its intention to legislate for an Investment Firms Prudential Regime ( IFPR) that would broadly mirror the EU IFR and EU IFD...

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CHECKLISTS

This flowchart outlines particulars of the threshold criteria prescribed in section 31(2) of the Children Act 1989 ( Ch A 1989), and identifies the public children law applications to which criteria pertain and apply......

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CHECKLISTS

The Pre- Action Protocol for Personal Injury Claims Below the Small Claims Limit in Road Traffic Accidents ( RTA Small Claims Protocol) is engaged for collisions taking place on or after 31 May 2021. For RTA personal injury matters, the small claims track cap for general damages—covering pain, suffering and loss of amenity ( PSLA)—now stands at £5,000, save for exceptions in CPR 26.10 and CPR 26.11. The protocol is intended for situations where a person has sustained injuries in a road traffic accident (including, though not confined to, whiplash) and wishes to pursue compensation, provided the sum claimed for the injury does not exceed £5,000 and the value of the case does not exceed £10,000. It operates for claimants pursuing personal injury compensation from RTAs within these injury and overall value limits. For additional guidance on using the RTA Small Claims...

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CHECKLISTS

' Twin peaks' regulatory structure The 2007–2008 financial crisis prompted a sweeping overhaul of the UK’s supervisory framework. The new model, effective from 1 April 2013, is widely referred to as ‘twin peaks’ regulation. Under this arrangement, responsibilities are divided between: Prudential oversight — undertaken by the Prudential Regulatory Authority ( PRA) for insurers, banks, building societies, credit unions and systemically important investment firms. Conduct supervision — undertaken by the Financial Conduct Authority ( FCA), which also carries out prudential regulation of investment firms that are not systemically important. The framework also encompasses the Bank of England (the Bank) and its Financial Policy Committee ( FPC), and the Payment Systems Regulator ( PSR), a subsidiary of the FCA that began operating in 2015. For a visual outline, see Practice Note: Regulatory structure diagram. For more on the UK regulators, see Overview: UK...

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CHECKLISTS

The moratorium in administration Central to administration, the moratorium operates as the principal device that enables a company rescue, a restructuring, or the disposal of the business. Its objective is to afford the company and its administrator a period of breathing space to shape and carry out proposals, and to scrutinise the position of the company, its business and its assets. That pause creates room for careful assessment and orderly planning. The consequence of the moratorium (and any interim moratorium) is that proceedings, enforcement and other steps cannot be taken against the company or its property while it remains in force. Claims or actions may only be commenced or continued with the administrator’s consent or the court’s permission. For further detail on the moratorium and its impact, refer to Practice Note: The moratorium in...

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CHECKLISTS

Note On 6 April 2025, changes to CPR 25 entered into force, renumbering the earlier provisions of CPR 25 and also revising elements of the wording concerning security for costs. This Practice Note describes the prior rule 25 as ‘old rule 25’ and, where applicable, points out any distinctions between the current CPR 25 and the old rule 25. Regarding the conditions that must be satisfied before the court is able to make an order for security for costs, CPR 25.13 was renumbered as CPR 25.27, and some of its provisions have changed accordingly. The old rule 25 can be found here: This Checklist proceeds on the basis that a claimant refuses to supply the security sought. It identifies the stages involved in obtaining security for costs, from the claimant’s first approach for security through to the cancellation of the security once the process has been...

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CHECKLISTS

This checklist sets out the reporting obligations under the UK’s new short selling regime. For more detail, see Practice Note: The new UK short selling regime. Background The Short Selling Regulations 2025 ( SI 2025/29) replace the assimilated UK Short Selling Regulation and introduce a new statutory framework for regulating short selling in the UK. The regime: Defines designated activities for short selling within FSMA 2000 Confers broad rule-making powers on the Financial Conduct Authority ( FCA) Maintains core transparency obligations while giving the FCA greater flexibility Equips the FCA with intervention powers in exceptional circumstances The FCA is consulting on proposed rules and guidance, with a new short selling sourcebook expected in April 2026. When does the UK short selling regime apply? It applies to market participants engaging in short selling of shares admitted to trading or traded on a UK trading venue, and to...

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CHECKLISTS

This Checklist has been archived and is not maintained This checklist is archived and no longer updated. The Insolvency ( England and Wales) Rules 2016, SI 2016/1024 ( IR 2016) were placed before Parliament on 25 October 2016 and took effect on 6 April 2017. Their purpose is to bring together the Insolvency Rules 1986, SI 1986/1925 ( IR 1986) and every statutory instrument that amended the IR 1986, SI 1986/1925 (all of which are repealed), to modernise and streamline the drafting, and to reflect changes in the law. For materials under the regime before 6 April 2017, see Practice Note: Formal creditors’ committees. This checklist serves as a summary destination table of the rules relevant to IR 2016, SI 2016/1024, Part 17 concerning creditors' and liquidation committees, and it substantially replaces Parts 2 to 6 of the IR 1986, SI...

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CHECKLISTS

Overview In order to satisfy obligations under the Financial Conduct Authority ( FCA)’s Consumer Duty, producers and distributors need access to details on the central features of a product or service, from its attributes and intended customer segment to the evidence underpinning consumer outcomes. Requirements to share information are fundamental to adhering to the Duty, enabling firms to act swiftly to tackle issues, avert consumer harm and secure good outcomes. This Checklist explains the duties on manufacturers and distributors to exchange information across the distribution chain and to issue notifications to counterparties and to the FCA under the Consumer Duty, in particular under PRIN 2A and FG22/5 Final non- Handbook Guidance for firms on the Consumer Duty. It covers the obligations to pass on information or alert other firms in the chain when harm or potential harm is detected, and to notify the FCA about firms...

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CHECKLISTS

This checklist Summarising the FCA’s findings, this checklist outlines examples of effective practice around implementing the FCA’s Consumer Duty, together with instances of weak practice drawn from areas the FCA has flagged for improvement. It provides the FCA’s sector-specific implementation portfolio letters, accompanied by links to practical guidance tailored to each sector......

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CHECKLISTS

This checklist helps practitioners grasp and consistently apply the FCA’s Consumer Duty requirements for evidencing fair value effectively. It should be considered alongside other relevant practical Consumer Duty materials and references: for information on the main elements of the Consumer Duty with general application, see Practice Note: The FCA Consumer Duty—essentials; also for a suite of sectoral guidance and checklists see: Consumer protection and FCA Consumer Duty—overview for key developments relating to the FCA’s Consumer Duty, see: The FCA Consumer Duty—timeline Background Under the Consumer Duty, four outcomes cover the central and key aspects of the firm–customer relationship. The second outcome is the Price and Value Outcome, which is concerned with an overarching obligation that products must deliver ‘fair value’ to customers. Under PRIN 2A.4: value is the relationship between the amount paid by a retail customer for the product and the benefits they can...

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CHECKLISTS

The Checklist The Checklist reviews which service providers fall within the scope of Regulation ( EU) 2022/2065, the EU Digital Services Act ( EU DSA), sets out what they must do to meet the Act’s principal duties, and highlights several core concepts. It also summarises key dates and milestones referenced throughout the implementation period across the EU. The EU DSA took effect on 16 November 2022. The cut-off for publishing figures on active monthly users was 17 February 2023. On 25 April 2023, the Commission designated 17 Very Large Online Platforms ( VLOPs) and two Very Large Online Search Engines ( VLOSEs). Those designated businesses must, within four months of designation, satisfy obligations under the EU DSA (see: LNB News 25/04/2023 74). On 19 December 2023, the Commission named three further VLOPs (see: LNB News 20/12/2023 32). All remaining...

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CHECKLISTS

The early conciliation ( EC) requirement The early conciliation ( EC) requirement—sometimes referred to as mandatory Acas early conciliation—obliges a would‑be claimant to give Acas specified details, including certain information, before issuing an employment tribunal claim, as provided by section 18A(1) of the Employment Tribunals Act 1996 ( ETA 1996). For more detail, see Practice Note: The early conciliation requirement. This Checklist explains which claims constitute ‘relevant proceedings’, and identifies those that are caught by the early conciliation requirement either because of: ETA 1996, s 18(1A), or a specific provision in the applicable legislation For guidance on relevant proceedings, see Practice Note: The early conciliation requirement— Relevant proceedings. Where a prospective claimant satisfies the early conciliation requirement, there is, in almost all cases, a statutory extension to the usual deadline within which a claim must be presented to an employment tribunal. This...

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CHECKLISTS

NOTE: This archived timetable outlines the usual sequence for a merger under The Companies ( Cross- Border Mergers) Regulations 2007, SI 2007/297, before those regulations were revoked at the end of the Brexit implementation period... Background The European framework governing combinations between companies in different EEA member states stems from Directive 2005/56/ EC, the Directive on Cross- Border Mergers of Limited Liability Companies ( Directive). The UK gave effect to the Directive through The Companies ( Cross- Border Mergers) Regulations 2007, SI 2007/2974, as subsequently amended by SI 2008/583, SI 2011/1606 and SI 2015/180 (together, the Cross- Border Mergers Regulations). Beyond setting out a merger mechanism, the Cross- Border Merger Regulations also regulate employee participation arrangements (see Employee participation arrangements below). The City Code on Takeovers and Mergers ( Code) applies in the usual manner and on the normal basis where at least one party to the...

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CHECKLISTS

When assessing an outsourcing arrangement, a number of competition law considerations arise. From a competition viewpoint, the principal questions are: whether the deal constitutes a notifiable transaction under merger control regimes, and whether the prohibitions on anti-competitive agreements are engaged. Overlooking these points can have serious outcomes, from agreements being void and unenforceable to substantial financial penalties. This Checklist offers a high-level summary of key issues and how competition law may affect outsourcing arrangements. An outline of an outsourcing The hallmark of outsourcing is that one or more external suppliers provide the customer with services for business processes previously handled in-house. Companies frequently move non-core functions—particularly IT, finance and HR—to specialist suppliers, sometimes offshore, who can offer cost-effective delivery due to: lower labour costs more modern technology, and sharing technology and infrastructure to support multiple customers. The scope of services transferred is often sizeable and may constitute a...

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CHECKLISTS

This flow chart outlines the criteria for permitting an appeal in family cases and the orders that may follow...

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CHECKLISTS

What this checklist covers This checklist sets out the principal matters a solicitor guiding a first time issuer must verify and, where appropriate, propose changes to, when reviewing English law terms and conditions governing an issue of debt securities......

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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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