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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

This checklist examines the route available to a party owed money (the creditor) to issue a statutory demand against an individual or company that owes the funds (the debtor) but cannot meet payment. It provides a high-level synopsis of the main considerations from a dispute resolution solicitor’s perspective. For detailed guidance and case law on statutory demands, see: Statutory demands for restructuring and insolvency professionals—overview For a general understanding of contractual debt claims and, in particular, points arising where debts are disputed, see: Practice Note: Debt claims Practice Note: Starting a contractual debt claim — a practical guide Starting a contractual debt claim—checklist For a checklist highlighting key considerations for a debtor on receiving a statutory demand from a dispute resolution standpoint, see: Responding to a statutory demand for dispute resolution...

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CHECKLISTS

This Checklist on making a Part 36 offer identifies the key factors that should be considered when drafting a Part 36 offer. Consideration What a Part 36 offer can be made in relation to You may frame a Part 36 offer to cover the entirety of the claim, a defined part, or a particular issue. It can likewise address a counterclaim or any additional claim, and it may extend to an appeal or cross-appeal arising from a trial judgment. However, a Part 36 offer is not available for an appeal against an interlocutory ruling. Guidance When to make a Part 36 offer An offer under Part 36 can be served at any point, whether before proceedings are issued or once they are underway ( CPR 36.7(1)). Where a matter proceeds to appeal, a new Part 36 offer should be advanced because the Part 36...

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CHECKLISTS

Introduction to freezing injunctions and scope of this checklist A freezing injunction (also known as a freezing order) is a temporary court order that prevents a respondent from disposing of or transferring its assets out of the relevant jurisdiction—namely England and Wales—or, in the case of a worldwide freezing order ( WFO), from moving them anywhere in the world. The court’s principal aim in granting such relief is to preserve the respondent’s assets so that, if the applicant later obtains judgment against the respondent, there will be assets available for recovery by the applicant and, if necessary, enforcement action. This Checklist explains how to make an application for a freezing injunction where claims are contemplated or already underway in a corporate or personal insolvency context. As the precise circumstances of each matter must be assessed, this Checklist does not claim to be...

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CHECKLISTS

An advance decision allows a person to set out refusals of specified medical treatment that will apply in the future if, at that time, they lack the capacity to consent to or decline such treatment. This Checklist highlights the points practitioners should work through when taking instructions and advising a client on creating an advance decision. Capacity Assess whether the client has the capacity to make an advance decision; refer to chapter 3 of the Mental Capacity Act 2005 ( MCA 2005) Code of Practice. Lasting power of attorney ( LPA) compatibility Ensure there is no inconsistency between the advance decision and any health and welfare LPA the client has put in place......

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CHECKLISTS

The following are some of the features and factors (not all of which will be readily discoverable at a very early stage) to consider when assessing whether a claim is appropriate for the LVI defence: The respective weight of both vehicles: a heavier vehicle striking a lighter one creates a greater impact than a crash between vehicles of comparable weight. Age and design of the vehicle: some models provide better shock absorption, for example with large bumpers. Location of impact: a direct rear-end hit passes more energy than a collision at an angle. Presence of a tow bar: a tow bar channels impact energy through the car, increasing injury risk. Handbrake applied: engaging the handbrake reduces the likelihood of injury. Claimant’s age and sex: females face a higher chance of whiplash, and risk rises with age. A...

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CHECKLISTS

Points to consider What is the most appropriate method of transfer? Consider: Think about whether you are transferring rights alone (eg drawn commitments) or also obligations (eg undrawn commitments). An assignment passes only rights, whereas a novation passes both rights and obligations. Novation is usually favoured for loan transfers because it conveys rights and duties together. If assignment is adopted, the obligations can be moved by novation. For more detail, see Practice Note: Transferring a loan by assignment. Whether consent can be obtained from the borrower? By law, an assignment does not require the counterparty’s consent. However, the facility agreement will often require borrower consent for an assignment, and for a novation as well. Sub-participation is sometimes used to transfer loans on...

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CHECKLISTS

Before commencing the arbitration Review any applicable limitation periods under the relevant law (general principle) Verify the arbitration agreement incorporates, or is deemed to incorporate, the LMAA Terms 2021 ( Paragraph 5) Establish the governing law of the arbitration agreement and the seat (default: English law and seat in England, unless otherwise agreed) ( Paragraph 6) Identify the number of arbitrators and the appointment method under the arbitration agreement and the LMAA Terms ( Paragraphs 8–11) Choose arbitrator(s) and set the appointment timetable, including any application to the LMAA President if required ( Paragraphs 8–12) ......

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CHECKLISTS

ARCHIVED: This checklist sets out a comparison of the admission requirements and principal ongoing obligations that formerly applied to a commercial company with equity securities listed on the premium and standard listing segments before 29 July 2024. It is no longer updated and is supplied for background information purposes only. A major overhaul of the UK listing regime took effect on 29 July 2024, removing the premium and standard listing segments and introducing a single listing category for equity shares of commercial companies. The commercial companies category is strongly disclosure-led and sits alongside other categories within the regime, including the shell companies, secondary listing and closed ended investment fund categories. The UK Listing Rules sourcebook commenced to implement these reforms and the Listing Rules sourcebook was revoked accordingly. For more detailed information, see Practice Note: Reform of the UK listing...

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CHECKLISTS

This flow diagram sets out the principal stages and regulatory factors in bringing debt securities to the Qualified Investor Bond Market ( QIBM) of The International Stock Exchange ( TISE). From appointing a listing agent to obtaining the grant of listing—it signposts key documentation, review milestones, and regulatory interactions throughout the entire process. What is the process and what rules apply to listing debt securities on the Official List of The International Stock Exchange?......

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CHECKLISTS

In March 2018, Euronext acquired the Irish Stock Exchange plc, which then joined Euronext’s federal structure and now trades as Euronext Dublin, with Ireland recognised as one of Euronext’s six core countries. Euronext is the foremost pan- European marketplace in the Eurozone, operating across Belgium, France, Ireland, The Netherlands, Portugal and the UK. Its mission is to energise pan- European capital markets to fund the real economy, uniting buyers and sellers in venues that are transparent, efficient and dependable. What are the rules applicable to listing debt securities on Euronext Dublin? Euronext Dublin— EU Regulated Market The Central Bank of Ireland ( CBI) is the competent authority responsible for reviewing and approving a prospectus ( Prospectus) for the purposes of the Prospectus Regulation ( EU) 2017/1129 ( PR). The PR prescribes the relevant annex items to be included in a prospectus, depending on the issuer’s profile and the...

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CHECKLISTS

STOP PRESS: A major, wide-ranging overhaul of the UK listing framework took effect on 29 July 2024, abolishing the premium and standard listing segments and introducing a unified category for equity shares of commercial companies. That commercial companies category is strongly disclosure-led and sits alongside other listing categories, including the shell companies, secondary listing and closed ended investment fund categories. A new UK Listing Rules sourcebook commenced to deliver these reforms, and the previous Listing Rules sourcebook was withdrawn at the same time. For more detail, see Practice Note: Reform of the UK listing regime—fundamentals for guidance. This Checklist represents the listing regime as it existed before 29 July 2024. A limited company may acquire its own shares if certain conditions set out in the Companies Act 2006 ( CA 2006) are satisfied under that statute. This is commonly referred to as a share...

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CHECKLISTS

This Checklist This Checklist outlines key points to consider when preparing or negotiating liquidated damages ( LADs) provisions in a building contract, with a particular emphasis on LADs for late completion. It offers practical pointers and guidance designed to help ultimately ensure that LADs provisions in a building contract are properly enforceable......

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CHECKLISTS

This checklist aims to assist you in assessing whether your arrangements ensure compliance with the legal and regulatory obligations connected to limiting liability within your practice framework. Please read this carefully in conjunction with: Limiting liability—law firms—overview......

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CHECKLISTS

Checklist For limited liability partnerships ( LLPs), most applicable rules stem from adapted company law rather than partnership law. The Limited Liability Partnerships ( Application of Companies Act 2006) Regulations 2009, SI 2009/1804 (the 2009 Regulations) apply numerous provisions of the Companies Act 2006 ( CA 2006) to LLPs, with suitable modifications. The 2009 Regulations also extend Parts 1, 2, 3 and 5 of the Companies ( Cross- Border Mergers) Regulations 2007, SI 2007/2974 to LLPs. Further, the Limited Liability Partnerships ( Accounts and Audit) ( Application of Companies Act 2006) Regulations 2008, SI 2008/1911 (the 2008 Regulations) apply CA 2006 requirements on accounts and audit to LLPs, again with appropriate amendments. This checklist outlines the CA 2006 provisions that are applied to LLPs under these regulations......

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CHECKLISTS

How to use this Checklist This Checklist flags issues that frequently emerge when negotiating and drafting the following agreement types: Design licence—pro-licensor Design licence—pro-licensee For further reading on design licensing, see these Practice Notes: Introduction to designs UK registered and unregistered designs Licensing intellectual property rights For example character merchandising agreements, consult the Precedents: Character merchandising agreement—pro-licensor and Character merchandising agreement—pro-licensee. For details of the key terms commonly found in a manufacturing agreement and designs licence, see: Manufacturing agreement and design licence—checklist. This Checklist can also, where appropriate, operate as the foundation for a straightforward non-binding heads of terms. For guidance on doing so, see Precedent: Heads of terms—commercial contracts. For support on negotiating an IP licence clause, refer to Practice Note: Negotiation guide—intellectual property licence clause. Checklist schedule for proposed licence of designs Points to consider • Further information • Notes (if any) ( A) Key...

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CHECKLISTS

Checklist—acting for a tenant seeking landlord’s consent to carry out works This checklist, though not comprehensive, sets out principal actions and considerations when representing a tenant of commercial premises seeking the landlord’s consent to undertake works within its demised premises. For key steps and issues when advising a landlord that has received a tenant’s application for a licence to carry out works, see Licence for alterations—acting for landlord—checklist. For a transaction guide, see Practice Note: A practical guide to dealing with licences for alterations. This checklist does not address the additional matters relevant to alterations to an existing higher-risk building (eg, subject to certain exclusions, a building exceeding 18 metres or seven storeys in height and of a description prescribed in regulations—broadly (i) hospitals, (ii) care homes, or (iii) buildings with at least two residential dwellings (in England), or one...

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CHECKLISTS

Checklist This checklist, although not comprehensive, sets out the principal actions and considerations when advising a landlord of commercial property on a tenant’s request for a licence to undertake works within the demised unit. For the equivalent points when representing a tenant seeking consent for works, refer to: Licence for alterations—acting for tenant—checklist. For a transaction overview, see Practice Note: A practical guide to dealing with licences for alterations. This checklist does not address the additional matters that arise for alterations to an existing higher-risk building (eg subject to certain exclusions, a building over 18 metres or seven storeys and of a description specified in regulations—broadly (i) hospitals, (ii) care homes, or (iii) buildings that have at least two residential dwellings in England, or one residential dwelling in Wales—hence a mixed use building could fall within the higher-risk buildings regime). For guidance, see Practice Notes: Building Safety Act...

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CHECKLISTS

Attendance at [ insert name of police station ] police station on [ insert date ] at [ insert time ] Dear [ Sir/ Madam], We act for [ insert client's name ], who has confirmed they will attend an interview at [ insert name of police station ] police station at [ insert time ] on [ insert date ]. As you will know, [ insert client's name ] will be present on a voluntary basis, has fully co-operated with your investigation and continues to do so. Accordingly, we ask that the Custody Sergeant is kindly advised in advance that there is no necessity for [ insert client's name ] to be arrested......

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CHECKLISTS

This checklist outlines the principal points an employer should assess, and the provisions it ought to require, to achieve a clear and binding letter of intent ( LOI) on a construction project. Although the terms ‘contractor’ and ‘employer’ are used, the same approach applies to arrangements between a contractor and a sub-contractor. When drafting and negotiating an LOI, not every matter listed will be relevant; each should be considered in light of the specific circumstances. See Practice Note: Letters of intent—construction for further detail on letters of intent and, for an example of client guidance, see Precedent: Advice to clients—use of letters of intent. Key issues and clauses Parties’ particulars: Check that the employer’s and contractor’s full details are set out at the start of the LOI (including exact company names and, where appropriate, the company number) to prevent any doubt about the...

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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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