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
The tables below set out, for merger control jurisdictions worldwide, the following key timelines: time limits for submitting merger notifications initial review ( Phase I) investigation periods Deadlines to file notifications This table outlines the deadlines for lodging merger notifications, triggered by the signing of transaction documents or by other relevant triggering events......
How a sentence is reached When passing sentence, the court typically weighs the statutory sentencing range, the relevant Sentencing Council ( SC) guidance—including any offence‑specific guideline—the overarching guidance, and sentencing authorities from the Court of Appeal. The SC’s offence‑specific or general guideline provides a mandatory step‑by‑step method the court must apply. See Practice Notes: Sentences imposed following conviction and Sentencing Council General Guideline— Overarching Principles. In most cases the court will consider: the appropriate starting point within the Sentencing Guidelines any aggravating features of the offence mitigation and the defendant’s personal circumstances any discount for a guilty plea whether the offender is dangerous and presents a significant risk of harm through further specified offences any suitable ancillary orders the totality of the sentence to ensure proportionality to the offending...
This Checklist It sets out the key questions and issues to raise with a prospective claimant bringing a misrepresentation claim. For guidance on what amounts to a misrepresentation claim and the essential elements required to establish one, see the following Practice Notes: Misrepresentation—what it is and similar claims Misrepresentation—what statements will establish a claim? Misrepresentation—what is inducement? Misrepresentation—falsity (fraudulent, innocent or negligent misrepresentation) Assessing the merits of a misrepresentation claim requires a detailed and thorough examination of the facts and enquiries into the pre-contract negotiations and discussions that may have taken place many years before......
This Checklist considers possible defences for a defendant facing a claim for misrepresentation. For assistance in understanding the nature of a misrepresentation claim and the core elements needed to prove it, refer to these Practice Notes: Misrepresentation—what it is and similar claims Misrepresentation—what statements will establish a claim? Misrepresentation—what is inducement?......
This Checklist This Checklist outlines the key steps and issues to consider when deciding whether someone is entitled to, and actually receives, the national minimum wage ( NMW). It covers entitlement to the minimum wage, including identifying the pay reference period, calculating a worker’s pay in that period, assessing the number of hours worked by reference to salaried work, time work, output work and unmeasured work, determining the hourly rate for pay, comparing that hourly rate with the minimum wage, required record keeping obligations, and the sharing of information. For further guidance on the NMW generally, see Practice Note: National minimum wage. For information on current NMW rates, see Practice Note: Employment-related statutory rates and limits— National minimum wage ( NMW). The government publishes guidance on calculating the minimum wage (which also applies to workers entitled to the National Living Wage). This guidance...
ARCHIVED: This Checklist has been archived and is not maintained. In broad terms, this computation focuses on real cash movements and payments between the employer and the worker (in both directions) rather than on entitlements. For more detail on the components of this calculation, refer to Practice Note: National minimum wage, especially the section titled: Checking pay against the minimum. For a checklist outlining the key points to consider when deciding whether someone is entitled to receive and does receive the minimum wage, see: Minimum wage compliance checklist......
A: Before you begin Before pursuing a merger, you and your law firm must hold a clear and candid view of your starting point—the firm’s current position, your strategic aims, and the capability to realise those aims. For further guidance, see Practice Note: Mergers—law firms. All principals should fully understand the: economics of your business, including sustainable profitability and cash flow funding requirements of the business risk and compliance framework and its track record Without such clarity, expectations may diverge and valuable time can be lost. This Checklist sets out the key issues to consider. It does not cover regulatory requirements, due diligence, warranties, deal structure and similar matters, which remain critical but will vary with the specifics of the transaction. The areas addressed here are those that, if tackled thoroughly, should give any law firm merger a...
Coronavirus ( COVID-19): This Archived Practice Note provides guidance on areas that were temporarily modified to aid the handling of the coronavirus ( COVID-19) pandemic. For more detail, refer to Practice Notes: Local authority meetings during the coronavirus ( COVID-19) pandemic [ Archived], and Coronavirus ( COVID-19)—governance tracker [ Archived]. Elements of accessibility The table below outlines the position within a standard authority. Certain authorities extend further rights to councillors and to the public in some cases......
Checklist This Checklist is aimed at law firms. It is intended to help you assess whether you have the necessary systems in place to monitor client feedback effectively. It should be read alongside the subtopic: How to measure client satisfaction......
Legislation safeguards the pension entitlements of members of occupational pension schemes and other employment‑related benefit arrangements, including workplace personal pension schemes that receive employer contributions, while they are away from work on statutory family leave. Statutory family leave encompasses: maternity leave paternity leave adoption leave parental leave shared parental leave parental bereavement leave carer’s leave Maternity leave Occupational pension schemes are taken to include a maternity equality rule requiring periods when a member is on maternity leave to be treated in the same manner as periods when they are not on maternity leave. This maternity equality rule applies to both paid and unpaid ordinary maternity leave ( OML), as well as to paid additional maternity leave ( AML). As a result, under this rule, time spent on OML and paid AML in a defined benefit ( DB) scheme is...
Market definition is fundamental to the application of competition law. This Checklist helps to determine the relevant market for competition-law purposes and the kinds of evidence that can be used when delineating a relevant market (see further, Market definition and analysis in EU and UK competition law)... Framework for assessment Keep in mind the purpose of defining the market in competition cases. Market definition is not a goal in itself; it is a tool for identifying the strongest and most immediate competitive pressures acting on a firm or firms for the evaluation of market power. Key points to bear in mind when defining and analysing markets are as follows: Consider the context in which the market-definition exercise is undertaken (whether it concerns the assessment of restrictive agreements, abuse of dominance, or mergers)......
ARCHIVED: This timeline has been archived and is no longer maintained. For developments from January 2024 onwards, see EU Market Abuse Regulation—timeline for issues relating to the EU Market Abuse Regulation, or UK Market Abuse Regulation—timeline for matters concerning the UK Market Abuse Regulation. For further guidance on the EU Market Abuse Regulation, see Practice Note: EU Market Abuse Regulation ( MAR)—essentials. For further guidance on the UK Market Abuse Regulation, see Practice Note: UK Market Abuse Regulation ( MAR)—essentials. Date: 9 November 2023 Source: European Economic Area Joint Committee Documents: Decision of the EEA Joint Committee No 98/2023 of 28 April 2023 amending Annex IX ( Financial services) to the EEA Agreement [2023/2252]; Decision of the EEA Joint Committee No 99/2023 of 28 April 2023 amending Annex IX ( Financial services) to the EEA Agreement...
This Checklist This Checklist outlines the actions required when shaping and composing a marital or civil partnership agreement. It also covers formalities, including execution as a deed, duties affecting third parties, and the court’s jurisdiction. It further addresses financial disclosure, property that is non-matrimonial or outside the civil partnership, fairness, undue influence, and the need for independent legal advice for marital agreements, and can serve as an aide-memoire when drafting a marital or civil partnership agreement. It is suitable for use with pre-nuptial, post-nuptial, and separation agreements......
Manufacturing agreement and know-how licence This Checklist sets out the principal provisions commonly included in a manufacturing agreement and a know-how licence. Use it as a prompt when drafting, reviewing or negotiating these contracts. For examples of manufacturing agreements, see Precedents: Manufacturing agreement—pro-customer Manufacturing agreement—pro-manufacturer For additional guidance on licensing know-how, see Practice Note: Know-how—protection and licensing. Where appropriate, this Checklist can also act as the starting point for concise, non-binding heads of terms. For advice on this, see Precedent: Heads of terms—commercial contracts. Checklist schedule for proposed manufacturing agreement and know-how licence ( A) Key commercial considerations Notes Parties Parties: verify each party’s legal status, and whether any third parties (for example, group affiliates) will benefit under the proposed agreement. Third-party guarantees: confirm whether any third party will guarantee a party’s performance or financial...
How to use this Checklist This Checklist flags typical issues that arise when negotiating a manufacturing agreement and a design licence, helping you focus on key points at each stage. For further information on the licensing of designs, consult the materials below and see the following Practice Notes: Introduction to designs UK registered and unregistered designs Licensing intellectual property rights For standalone design licences, consult Precedents: Design licence—pro-licensor and Design licence—pro-licensee. See also: Licence of designs—checklist. For character merchandising arrangements, refer to Precedents: Character merchandising agreement—pro-licensor and Character merchandising agreement—pro-licensee. Where suitable, this Checklist may serve as the basis for a brief, non-binding heads of terms. For guidance on how to do this, see Precedent: Heads of terms—commercial contracts. Checklist schedule for proposed manufacturing agreement and design licence The following notes apply to the key commercial considerations identified and outlined...
This Table This table summarises the hallmarks for the Mandatory Disclosure Rules ( MDR), in force from 28 March 2023, which implement the Organisation for Economic Co-operation and Development ( OECD) model rules in the UK and, from the same date, entirely repeal EU Directive 2018/822 ( DAC 6) in the UK. It is intended to be consulted alongside the main Practice Note: Disclosable cross-border tax arrangements— Mandatory Disclosure Rules ( MDR). The generic hallmark for a Common Reporting Standard ( CRS) avoidance arrangement covers any arrangement where it is reasonable to conclude it was structured to circumvent CRS legislation, or has been promoted as doing so, or achieves that effect......
This Checklist applies to a property disposal and considers what must be revealed to a purchaser and the manner of disclosure by deducing title, preparing the contract and answering preliminary enquiries. It addresses both the content of disclosure and the way it is provided. What must the seller disclose? Nature of seller’s title Unless agreed otherwise, a purchaser may proceed on the basis that the property is freehold and free from encumbrances. In practice, that presumption is seldom relied upon, as title will be deduced to the buyer and the contract will set out the property particulars together with any incumbrances (see Drafting the contract below). However, this starting point is rarely relied upon in practice. Rather, evidence of title is produced and the paperwork captures relevant particulars and burdens. Latent defects Treating the property as freehold and unburdened by incumbrances places the seller under a duty to...
More than 150 jurisdictions operate merger control, or regimes akin to it. Within these systems, competition regulators may prohibit a deal entirely, or approve it subject to remedies, whether agreed or imposed. This Checklist sets out practical points to bear in mind when managing filing obligations across multiple jurisdictions. For overviews of merger control rules in every jurisdiction, see MJ merger grid—jurisdiction and MJ merger grid—procedure. For distilled takeaways, consult Key learning points from MJ reviews—anomalies, absurdities and potential pitfalls. It also flags issues commonly seen in practice. Guidance is provided in those resources. What transactions fall within merger control rules? Relevant transactions Across most regimes, including the EU, merger control captures any deal that places formerly independent undertakings under common control. Control is often defined broadly. Acquisitions of control—sole v joint control Control can rest with a single party, or be shared with one or more...
This checklist sets out guidance on the issues and dialogue at Annual General Meetings ( AGMs) of listed companies and AIM companies. It spans legal considerations, corporate governance best practice and pragmatic pointers, together with advice for the chair and company secretary on preparing for debate and unforeseen occurrences at a company’s AGM effectively. The chair presiding over the meeting is charged with steering discussion during the meeting and must act in a neutral fashion. It falls to the chair to keep debate in check and determine when to bring discussion on a specific item to a close once they judge it has been aired fully and allowed a spectrum of opinions to be expressed. While the UK belonged to the EU, Directive 2007/36/ EC (the Shareholder Rights Directive) enshrined shareholders’ entitlement to receive answers to questions at general meetings put to them. That...
This checklist helps you to manage change within your organisation. It provides a list of suggested steps to work through for each planned change, along with questions to consider for each one. Managing change—suggested steps Key considerations Create impetus Do you have a clear and pressing case to act right now? Is this rationale widely and clearly understood? Can you express this case with facts, data, and numbers? Have you trialled your proposed message with other people? Build your champions Who will act as your executive sponsor? How involved will they be? Who in your team...
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 ]...