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
This Checklist outlines actions to raise awareness of, and enhance, well-being within the in-house legal team. Management training and development - equip managers with the core capabilities and insight to properly oversee and champion team well-being by making sure they are trained in: mental health awareness and recognising early warning signs. See Practice Notes: Understanding mental health and well-being and Well-being in legal teams emotional intelligence and effective active listening skills. See Practice Note: Unlocking your emotional intelligence-how working better with others helps to put you ahead conducting supportive well-being conversations setting the tone by being self-aware Mental health support structure - establish supportive systems and resources......
This quick-reference checklist supports calculating whether an applicant meets the relevant thresholds for eligibility under family immigration routes. It specifically helps with reviewing both the main financial requirement and the adequate maintenance requirement for routes under Appendix FM of the Immigration Rules... Which financial requirement applies? New application from 11 April 2024: £29,000 Renewal or extension from 11 April 2024 (including fiancés converting to partner): £18,600 (plus applicant child increment, capped at £29,000) Pending application made before 11 April 2024: £18,600 (plus applicant child increment, no cap) Sponsoring applicant in receipt of a specified benefit or applying on a specified route (e.g. as a parent): Adequate maintenance based on current income support rates (see below) Where applicable, child increments are: +£3,800 for the first child and +£2,400 for each extra child; e.g. +1 child = £22,400, +2 children = £24,800, +3...
Section 678(1) of the Companies Act 2006 ( CA 2006) provides: When someone is purchasing, or planning to purchase, shares in a public company, it is unlawful for the company itself, or for any company that......
This checklist sets out various considerations and questions for a potential franchisor when weighing up the adoption of a franchise business model. Initial considerations Is the business model franchisable? Certain models may not lend themselves to franchising; for example, a business with low margins, where customer custom is founded on allegiance to a particular individual, or where the model is restricted to a very specific locality indeed. Who are the main competitors in the market and what market share do they hold? A franchisor will need to assess the barriers to entry into the market, as well as the cost of acquiring a market share in that market. Who is the ideal customer for the product or service? As the franchise model lets businesses scale quickly, the franchisor must be sure that this ideal customer can be identified in many different and varied...
Does a seller need to disclose land contamination to a buyer? If the seller knows the land is contaminated, there is no obligation to reveal this to a purchaser; the principle of ‘buyer beware’ applies. However, when responding to CPSE enquiries, the seller must avoid any misleading statements. 16.4 Please provide (so far as the Seller is aware) details of: (a) historic and current uses of the Property and activities undertaken there; and (b) whether any hazardous substances, or contaminative or potentially contaminative materials, are in, on or beneath the Property, including asbestos or asbestos-containing materials, any known waste deposits, present or former storage areas for hazardous or radioactive substances, existing or previous storage tanks (above or below ground), and any parts of the Property that are or were landfill. A seller will typically seek the benefit of the ‘sold with...
The early conciliation ( EC) requirement Also referred to as mandatory Acas early conciliation, this duty requires a prospective claimant to supply certain information to Acas before submitting a claim in the employment tribunal, as part of the EC requirement procedure......
Checklist This checklist sets out principal matters to address when launching an internal inquiry into suspected criminal conduct. For fuller guidance, see Practice Note: How to plan and conduct an internal investigation. What is the purpose of the investigation? Prioritise fact-finding over determining liability. What is the scope of the investigation? Create clear terms of reference. Decide who should undertake the investigation and assign roles within the investigation. If Board members will be involved, verify whether a board resolution is required to authorise this. Take legal advice on likely Legal Professional Privilege ( LPP) issues. Ensure the Board, or a duly constituted...
This Checklist This Checklist outlines the principal issues to address, and supplies practical guidance, when drafting and bargaining over entire agreement clauses in a business-to-business ( B2B) contract. It reviews the impact of common law and statutory controls, including the Unfair Contract Terms Act 1977 ( UCTA 1977) and the Misrepresentation Act 1967 ( MA 1967). The purpose of an entire agreement clause is to give the parties assurance that the whole of their agreement is set out in writing and to ensure that any pre-contractual representations, statements, arrangements or discussions do not form part of the contract they are entering into. Statements are often made by one party to the other during pre-contract negotiations (for example as part of a sales process). Disputes may arise over whether, or which, statements were intended to be part of the contract or might otherwise give rise to...
This Checklist Below is a guide to EU Member States operating compulsory and standstill foreign direct investment ( FDI) regimes. For more information about the points at which FDI review thresholds are met within each EU Member State,......
Defending a claim for judicial review-checklist This checklist highlights the principal points for defendants facing judicial review proceedings generally. It also offers supplementary guidance where proceedings are to be brought in the Upper Tribunal ( UT). On receipt of a pre-action protocol letter Confirm that the intended claim falls within the UT’s jurisdiction. If you consider it does not, make this clear in your pre-action response to the proposed claimant. Considering whether the case is properly defensible and whether it is cost-effective to contest, issue a response within 14 days (unless a shorter, properly requested timeframe has been set by the proposed claimant). Review the documents and information sought in the pre-action letter and observe the duty of candour when providing any material. On receipt of the claim form Check whether the claim has been issued in the High Court or the UT. ...
This Checklist This Checklist sets out points to weigh up when preparing an arbitration agreement or clause. While parties may not be focussed on potential disputes during negotiation of the substantive contract, it is prudent to examine the arbitration provisions carefully, taking specialist advice where needed. If an issue later arises under the main agreement, the parties will not want to lose time deciding-and even litigating-how the dispute should be resolved. A precedent arbitration clause for inclusion in a contract is available here: Arbitration clause. When drafting an arbitration agreement, consider: in general: Is the agreement drafted with clarity? Reducing ambiguity is widely regarded as essential in any agreement, and that guidance applies equally to arbitration provisions. Have you used a standard or model clause from an...
ARCHIVED This document is archived and no longer maintained. For more recent updates, see Checklists: UK securitisation regime-timeline and EU Securitisation Regulation-timeline. In September 2015, the European Commission unveiled the Action Plan for Capital Markets Union (the Plan). The Plan aims to integrate capital markets across the EU’s Member States, stimulate investment and support growth within the EU. It set out five principal steps to deliver a Capital Markets Union, including strengthening banks’ ability to lend, with a priority on reviving simple, transparent and standardised ( STS) European securitisation. On 28 December 2017, Regulation ( EU) 2017/2402 (the EU Securitisation Regulation) and the related Securitisation Prudential Regulation ( EU) 2017/2401-amending the Capital Requirements Regulation ( EU) 575/2013-were published in the Official Journal of the EU. These rules entered into force on 17 January 2018 and have applied directly across the EU from 1 January 2019. They cover...
ARCHIVED: This Practice Note is archived and is no longer maintained This tracker outlines the Financial Conduct Authority ( FCA) consultation papers issued in 2023, together with any subsequent rules and guidance. For FCA consultation papers from other years, see: FCA consultation paper trackers. For Prudential Regulation Authority ( PRA) papers from 2017 and Financial Services Authority ( FSA) papers from 2008 to 2013, see: PRA consultation paper tracker [ Archived] FSA consultation paper tracker [ Archived] Regulation of capital markets CP23/33: Payments to data providers and forms for Data Reporting Services Providers, including Policy Statement for the framework for UK consolidated tape ( CP23/15) The FCA has released consultation paper CP23/33. Responses are invited by 9 February 2024. Publication date: 20 December 2023. End of...
Entities required to obtain and deliver PSC information to Companies House for the central register: Entities not required to obtain and deliver PSC information to Companies House for the central register: UK companies limited by shares, covering dormant entities, (save where they are admitted to trading on a UK regulated market, an EU regulated market, or on specified markets set out in Schedule 1 to the PSC Regulations) UK guarantee-limited companies......
Competition authorities with jurisdiction in Ireland Competition authorities operating in Ireland, chiefly the Competition and Consumer Protection Commission ( CCPC) and, where applicable, the European Commission, possess broad powers to carry out surprise inspections, commonly called ‘dawn raids’. Such raids are a central investigative device for enforcing Irish and EU competition law, particularly in matters involving serious and grave breaches of competition rules like alleged cartel conduct, abuse of dominance, and wage‑fixing arrangements. For companies trading in Ireland, the unannounced arrival of the regulator’s authorised officers at their premises without prior warning can be both highly disruptive and risky. Businesses must be dawn raid‑ready to mitigate disruption and to safeguard their legal entitlements while meeting statutory duties throughout an inspection. This Checklist outlines pragmatic pointers to consider before a dawn raid, including forming a dawn raid response team, alongside key priority steps to take during the...
This Checklist supports trustees in reviewing and adapting their working practices concerning the personal information they gather, handle and continue to retain about settlors, protectors, beneficiaries and other individuals associated with the trust. For a comprehensive introduction to Retained Regulation ( EU) 2016/679, the UK General Data Protection Regulation ( UK GDPR), drawing together key practical guidance, see the UK data protection law collection. ‘ Assimilated law’ is the term now used for retained EU law ( REUL) that remains in effect after the end of 2023. Re-classifying REUL (and related terminology) as assimilated law indicates a shift in its standing and treatment under UK law, meaning it is generally interpreted by reference to ordinary domestic law and principles. From 1 January 2024, REUL becomes ‘assimilated’ into domestic law because it is, in broad terms, divested of EU-derived...
Techniques for controlling time and costs in arbitration This Checklist stems from the ICC publication, Techniques for controlling time and costs in arbitration. It targets tribunals, equipping them with approaches for running streamlined proceedings. It is likewise valuable to practitioners preparing for arbitration. Set out below are practitioner-focused pointers drawn from the ICC’s report. Timetable Make every reasonable effort to meet the timetable and seek extensions only when genuinely justified in the circumstances. Consider whether hearings can be dispensed with, or instead conducted by telephone where appropriate. ......
Under section 14 of the Proceeds of Crime Act 2002 ( POCA 2002), the court will ordinarily impose a confiscation order before passing sentence on the defendant, yet it can defer the confiscation proceedings for a defined period of up to two years from the date of conviction-see Practice Note: Postponement of confiscation proceedings. If proceedings are postponed, the court will typically direct a timetable for the exchange of material required by POCA 2002 (frequently referred to as the confiscation timetable). The outline below identifies the documents exchanged for these purposes, the point at which they are required, and key points for practitioners to bear in mind when reviewing them. Document: Required where: Commentary Information by defendant in response to an order under POCA 2002, s 18 Where the court proceeds to make a confiscation order under POCA 2002, s 6(3)(a) (the prosecutor seeks an order) or POCA...
This checklist outlines the competition law factors that matter for corporate transactions... Preliminary considerations Before approaching the other party, it is vital to: Assemble a deal team and set up clear lines of communication across all relevant parts of the business. You may need specialist advisers, depending on PR needs, anticipated complexity or regulatory matters, for example: lobbying/ PR specialists economists accountants Be careful with document creation (internal and external) and with public and internal statements Manage expectations, including any potential competition issues and early timing considerations Confirm that the proposed transaction has a legitimate objective Consider preserving legal privilege for relevant communications (see further, Legal privilege in EU competition...
This Checklist outlines a non-exhaustive set of points to assess when a landlord gives notice under section 13 of the Housing Act 1988 ( HA 1988) to change the rent payable under an assured periodic tenancy in the private rental sector from 1 May 2026 onwards... Initial considerations Verify the tenancy is an assured tenancy ( AT) under HA 1988. Ensure the AT criteria are met and none of the exclusions apply (for example, tenancies granted by local authorities, business tenancies or holiday lets). See Practice Note: Private sector assured tenancies-granting- Criteria for an AT Confirm that more than 52 weeks have passed since the date the first period of the AT began, or since any previous rent determination took effect. The landlord cannot begin the process to alter the rent until after this timeframe Check whether a notice under HA 1988, s 13 to...
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 ]...