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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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Most recent Checklists

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CHECKLISTS

This is a Checklist of the main issues that an employer will need to consider when seeking a medical report on a current employee during the employee’s employment: Clarify the objective of the report clearly. See Practice Note: Medical reports—data protection issues and AMRA 1988— Purposes of medical report. Explain why health information is required and set out the grounds for requesting a medical report—is there a defined element of the role that necessitates it, or is the aim to evaluate overall health, eg for a physically demanding post? Set the scope of the report—identify precisely what the employer needs to know, avoiding intrusion where it is not needed or relevant. Consider whether involving an occupational health ( OH) professional or service could limit the volume of health data the employer processes. Specify who will have sight of the...

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CHECKLISTS

This Checklist outlines the principal steps a creditor should take to secure and execute a charging order against land, with clear pointers to fuller guidance provided at each stage. Preliminary considerations Confirm there is an appropriate judgment debt, verify the debtor holds an interest in land, and also weigh any other practical matters. See Practice Notes: Charging orders and orders for sale—practical considerations Charging orders—what are they and when to use them— CPR 73 Application Decide if the application has to be filed with the Civil National Business Centre. See: Charging orders—is this a CNBC or non- CNBC case?—flowchart......

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CHECKLISTS

For trustees and managers of occupational pension schemes: Confirm that the scheme’s provisions, criteria and practices ( PCPs) have been examined and reviewed to verify compliance with the non-discrimination rule. Where a PCP seems prima facie discriminatory and appears not to fit an exemption, raise with employer the question of whether an objective justification can be demonstrated. Understand how both courts and tribunals typically assess the objective justification defence in general. Do not treat generalisations or stereotyped assumptions as an adequate answer or satisfactory explanation......

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CHECKLISTS

When drafting or negotiating a deed of novation in the context of a design and build construction project where a consultant is being novated from the employer to the contractor (see Practice Note: Novation in construction projects), the following should be taken into account: Consideration Confirm that the novation is supported by consideration. If it is absent, or its existence is uncertain, the novation should be executed as a deed. Underlying agreement The deed of novation should identify the original appointment under which the consultant was engaged, together with a concise summary of the services they were retained to provide. Declaration of novation The deed should record (typically in the recitals) that the consultant and the former employer have agreed to transfer the underlying agreement to the new employer (that is, the contractor) on the terms contained in the deed of...

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CHECKLISTS

This Checklist sets out the principal jurisdictional aspects of the UK merger control regime and provides practical direction for assessing whether to voluntarily notify a transaction to the Competition and Markets Authority ( CMA), or alternatively, whether a tactical decision might be to proceed without notification in the hope of ‘flying under the radar’. Characteristics of the UK merger control system The merger control system of the UK diverges from most other jurisdictions in a number of respects: the UK’s merger control regime is voluntary by virtue of its non-suspensory nature......

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CHECKLISTS

Why apply for a Norwich Pharmacal Order? A Norwich Pharmacal Order ( NPO) is an effective means of obtaining information that would not otherwise be accessible, enabling a party to commence and advance a claim, particularly to reveal the identity of a likely defendant. Where a third party holds details about a prospective defendant and has become involved in the alleged misconduct (though typically without personal liability), the court, exercising its equitable jurisdiction, may order that third party to disclose the information via an NPO... For more on the court’s jurisdiction to grant an NPO, consult Practice Notes: Norwich Pharmacal orders ( NPOs) and Norwich Pharmacal orders—making an application. When working through the Checklist, the third column can be used to note observations or comments as each stage is...

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CHECKLISTS

FORTHCOMING DEVELOPMENT: Section 10 of the Finance Act 2022 will raise the normal minimum pension age ( NMPA) from 55 to 57 on 6 April 2028, except for members of the public service pension schemes for firefighters, police and the armed forces. The Finance Act 2022 will also permit members of registered pension schemes to take benefits before 57 if, on or before 4 November 2021, they met certain conditions: they already had an ‘unqualified right’ to take benefits; or they were in the course of a substantive transfer to a scheme providing an unqualified right to a protected pension age below 57 on or before that date. To rely on this new 2028 protection, the scheme’s rules must have included, as at 11 February 2021, an unqualified right to access scheme benefits before age 57. For further...

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CHECKLISTS

ARCHIVED: This Practice Note is archived and is no longer maintained. A bank loan is treated as a non-performing loan ( NPL) if more than 90 days pass without the borrower making the agreed instalments or interest payments. Banks experienced an accumulation of NPLs in their books when borrowers' inability to repay was intensified by the financial crisis and subsequent recessions. When NPLs are proportionately high, banks' capacity to manage the riskiness of their lending is diminished. NPLs are a supervisory priority for the European Central Bank ( ECB), which monitors the overall level of NPLs across euro area banks. Under the supervisory review and evaluation process ( SREP), the ECB assesses whether individual banks adequately manage loan risk and whether they have suitable strategies, governance arrangements and processes in place. The ECB also regularly undertakes co-ordinated exercises to review the asset quality of the banks it...

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CHECKLISTS

This Checklist summarises the UK Corporate Governance Code requirements relating to the composition of the nomination committee of quoted companies together with best practice guidelines of major institutional investor representative bodies UK Corporate Governance Code ( UKCG Code) Most members of the nomination committee should be independent non-executive directors. The company chair should not preside over the nomination committee when it is considering the appointment of their successor. Reference: 2018 UKCG Code, Provision 17; 2024 UKCG Code, Provision 17 Institutional Shareholder Services Inc ( ISS) A majority of the nomination committee should comprise independent non-executive directors. No fewer than half of the committee’s members should be independent. For AIM-listed companies, and other quoted companies outside the FTSE 350, FTSE Small Cap and FTSE Fledgling indices, at least half of the nomination committee should be...

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CHECKLISTS

ARCHIVED This Checklist is archived and is not maintained or updated. It considers how UK courts would apply Regulation ( EU) 1215/2012, Brussels I (recast)—which concerns the allocation of court jurisdiction for civil and commercial matters—if the UK were to leave the EU on exit day without a deal, the so‑called ‘no deal Brexit’ scenario. ‘ Exit day’ has the meaning given by section 20 of the European Union ( Withdrawal) Act 2018. The Checklist reviews the Regulation’s jurisdictional articles and evaluates whether the UK courts will apply them and, if so, in what way. The outcome varies depending on whether proceedings are started before exit day (with the jurisdictional issue decided afterwards) or initiated after exit day. The principal UK instrument is the Civil Jurisdiction and Judgments ( Amendment) ( EU Exit) Regulations 2019, SI 2019/479. Coming into force on exit day, it...

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CHECKLISTS

ARCHIVED : This Checklist has been archived and is not maintained. This Checklist assesses the stance EU courts are anticipated to take in relation to the application of Regulation ( EU) 1215/2012, Brussels I (recast), should the UK leave the EU on exit day without an agreement, the so‑called ‘no deal Brexit’ scenario. In particular, it considers and reviews the Regulation’s articles that address jurisdiction, together with the effects of a no deal Brexit on their practical application in proceedings featuring a UK element (whether involving a defendant domiciled in the UK, a jurisdiction agreement in favour of a UK court, or parallel or related proceedings brought before the UK courts). The position differs depending on whether proceedings were commenced prior to exit day (with the jurisdictional dispute to be determined after that date) or whether the proceedings were instituted after exit day......

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CHECKLISTS

ARCHIVED : This Practice Note has been archived and is not maintained. A range of jurisdictional regimes dictates whether a court may hear a dispute. This Checklist reviews the anticipated impact of Brexit on how different courts apply those rules when determining the effect of a particular jurisdiction agreement (also referred to as a choice of court agreement) after exit day. The rules examined are: Regulation ( EU) 1215/2012, Brussels I (recast) Lugano Convention 2007 Brussels Convention Hague Convention on Choice of Court Agreements national laws It does not address Regulation ( EC) 44/2001, Brussels I since, with the passage of time, it is unlikely to be relevant for determining jurisdiction. Nor does it cover specialist conventions dealing with jurisdiction, such as the United Nations Convention on the Carriage of Goods by Sea ( Hamburg rules). The Checklist assesses any change (if any) in the application of these rules as a...

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CHECKLISTS

Checklist This Checklist outlines practical actions for your first week in a new role as an in-house lawyer. It highlights relevant Precedents you can use or adapt to support these steps. There is space for you to note whether you have completed each action and to include comments. Use the section provided to tick off actions and add observations. It should be read together with Practice Note: Finding your feet in-house—your first week. Day 1 Your first day will be dominated by practicalities. Begin by considering your own needs, eg your health, safety and security, your contract, travel to the office, and office access: Practical step: ☐ Meet with your line manager Further details: Keep this meeting fairly informal, but flag the need to arrange a more structured session soon—perhaps in your second week with the...

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CHECKLISTS

A meeting with your line manager on your first day Setting up a meeting with your line manager on day one of your new role is strongly advisable. Although it will most likely be an initial ‘getting to know you’ chat, there are several questions you can raise to help you feel more at ease in the position. If you are the only in-house lawyer or leading an internal legal team, your line manager will typically be the CEO or Finance Director, though it could be any other director. If you are joining an existing team, your line manager may sit in a legal, regulatory or compliance function, for example: Company Secretary General Counsel Senior Solicitor Legal Director Compliance Director Alternatively, they may hold a non-legal post, such as Finance Director or CEO. In a larger team with multiple layers in the...

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CHECKLISTS

Where you are taking over your role from someone else and you are offered a handover Make the most of any chance to connect with your predecessor—even a short telephone call can be invaluable. Even minimal contact can surface practical pointers and context you might otherwise miss. This Checklist is for new in-house lawyers joining an organisation to replace the organisation’s previous in-house lawyer. It highlights key areas to address during any handover, however brief, and should be read alongside Practice Note: Taking up a new role in-house—replacing a previous in-house lawyer. Use what you hear to shape your immediate focus, not to constrain your judgement. That said, the position is now yours and you need not feel compelled to continue exactly as before. There are always several ways to approach matters and you should leave your own imprint on the role. Build on what was...

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CHECKLISTS

This Checklist This Checklist outlines several principal steps that schemes must undertake with effect from 24 July 2014 to meet the requirements of section 29 of the Pensions Act 2011 (“section 29”). That provision revises the meaning of money purchase benefits in section 181 of the Pension Schemes Act 1993, with the effect that some categories of benefit cease to be money purchase. For further detail on the impact of the updated statutory definition of money purchase benefits on schemes, refer to Practice Note: Money purchase benefits—the transitional regulations [ Archived]......

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CHECKLISTS

Basic terms At the outset, assess whether overage suits the transaction. Your client might be better protected by agreeing a higher purchase price or by entering into a conditional contract instead. Overage provisions can be intricate and expensive to negotiate. If overage is to be applied, consider when the seller expects or hopes to receive a further payment and how the buyer could avoid activating the overage. Ensure the overage includes clear definitions of: the overage period (note that, from 6 April 2010, the rule against perpetuities does not apply to most commercial interests and, if no overage period is specified, there is a risk the arrangement could be perpetual) the property that will be subject to the overage any individual units to be sold or constructed, making clear whether parking spaces and other ancillary areas form part of a unit for the...

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CHECKLISTS

Basic terms At the outset, assess whether an overage arrangement is right for the deal. Your client might be better served by agreeing a higher purchase price or entering into a conditional contract instead. Overage provisions can be intricate and costly to negotiate. If overage will apply, check that the terms reflect the buyer’s intended use of the site. the overage period (note that, from 6 April 2010, the rule against perpetuities does not apply to most commercial interests and, if no period is specified, there is a risk the agreement could be perpetual) the property that will be subject to the overage any individual units to be sold or built, making clear whether parking spaces and other ancillary areas are included within a unit for the overage calculation Include a ‘good faith’ clause, as this may help in the event of a dispute......

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CHECKLISTS

Funder’s primary objective When a buyer takes property subject to overage and seeks finance secured on that asset, a funder will require assurance that the overage provisions do not obstruct or curtail enforcement of its security. The lender must be confident its charge constitutes sound security over the property. Property and associated rights Assess the character of the site to be charged. Where it forms part of a broader development, consider whether, on a power of sale being exercised, the property will depend on rights over adjoining land held (or to be acquired) by the buyer, such as: rights of way rights concerning service media rights of support If such rights are necessary, agree a form of deed of easement to be annexed to the charge, and allow the funder to require grant of that easement when needed. Also examine whether the seller’s chosen mechanism for securing the overage is...

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CHECKLISTS

When to seek settlement? This checklist flags common issues that can emerge when negotiating and drafting a settlement agreement. For step-by-step guidance on negotiating and preparing a settlement agreement, consult the following Practice Notes: How to agree and draft a settlement agreement (non-employment claims) Settling disputes—how to document a settlement Settling disputes—drafting the settlement agreement Keep settlement in mind at every stage of a dispute, including pre-action. Consider the full range of resolution routes, such as direct negotiation between the parties or their legal advisers, assessing whether a Part 36 offer is suitable, or engaging in assisted alternative dispute resolution ( ADR), for example mediation. Following a rule change in October 2024, the court may now order parties to participate in ADR (see CPR 3.1(2)(o)). Review any contractual duties relating to settlement—such as a tiered dispute resolution clause—and ensure...

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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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