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 This Checklist outlines the principal terms within an IT services contract. It summarises the essential points a customer should weigh up when engaging a supplier for both implementation and day‑to‑day IT services. Such agreements may span a wide array of services, from straightforward website build and support arrangements to sophisticated technology outsourcing engagements. Which terms matter, and the level of detail required, will hinge on the particular services at issue and circumstances of the engagement at hand too. The Checklist is not comprehensive, but reviews a selection of common provisions worth considering for inclusion. Equally, certain suggested provisions may prove unsuitable or superfluous for a given contract. This Checklist is directed chiefly at customers. Its purpose is to provide a snapshot of the key terms a customer would typically seek to include in an agreement covering both...
Under the large and public client off-payroll regime Medium and large private sector entities with a UK link are obliged to: decide whether IR35 is applicable to an engagement involving an off-payroll worker; and in specified situations outlined below, operate Pay As You Earn ( PAYE) and account for employer National Insurance contributions ( NICs) on payments made to off-payroll workers For an overview of the IR35 framework, see Practice Note: IR35—introduction, developments and key difficulties. For details of the large and public client off-payroll regime, see Practice Note: IR35—the large and public client off-payroll regime. For guidance on the practical considerations for the end client and, where different, the fee payer, when an arrangement falls within the large and public client off-payroll regime, see Practice Notes: IR35—the large and public client off–payroll regime—practical considerations for the end client and IR35—the large and public...
ARCHIVED: This Practice Note is archived and is no longer maintained. On 20 December 2017, the European Commission unveiled plans to revamp the prudential regime for investment firms across the European Union, aiming to deliver a framework that is more proportionate and attuned to risk. Through the new package, contained in the Investment Firms Regulation ( EU) 2019/2033 ( EU IFR) and the Investment Firms Directive ( EU) 2019/2034 ( EU IFD), the majority of EU investment firms face streamlined prudential obligations compared with before, whereas large, systemic entities undertaking bank‑like functions and presenting comparable risks to banks are regulated and overseen in the same manner as banks. This timeline presents the principal milestones associated with the EU IFR and the EU IFD, in brief overview. Under the earlier system, investment firms in the EU, like banks, fell within the prudential framework...
Parties Who are the parties involved? In particular, specify: the investor(s) the managers the investee company (newco) Conditions Are there any conditions to completing the investment? What are each party’s obligations to meet those conditions, and by what deadline? Share subscription What will the investee company’s capital structure be? Which class and how many shares will each shareholder (the investor, the managers and any other shareholders) subscribe for? Warranties Who will give the warranties? Is it limited to the managers? Will they be provided jointly, jointly and severally, or on a several basis? How wide will the warranties be? It is usual for investment agreement warranties to centre on the business plan and the managers, as the acquisition agreement generally affords the investor sufficient protection regarding the company. What restrictions will apply to warranty claims? These may include: periods within which claims must be...
This Flowchart This flowchart sets out the principal stages and key factors for determining whether a party can validly rely on contractual force majeure ( FM) provisions in the context of an active conflict or war. For fuller guidance on each of these factors, within the context of FM affecting energy sector contracts, consult: War and force majeure in the energy sector—checklist......
Before acquiring a property or any interest in it, carrying out thorough and appropriate planning searches and enquiries is essential for any person or entity to ensure that the buyer will: not inherit undisclosed outstanding obligations or conditions, nor the burden of remedying or paying for earlier breaches of planning control be able to use and operate the property for the intended purposes If a breach of planning control or any outstanding liabilities are uncovered, the buyer can ask the seller to: remedy the breach before exchange, or settle the liability take out insurance for any loss in the value of the property and the legal expenses incurred in defending an attempt to enforce the breach negotiate a reduction in the sale price to reflect the buyer’s anticipated costs of remedying the breach or settling the...
This checklist outlines the principal steps for an intra‑group reorganisation carried out by selling shares in an English‑incorporated company to another English‑incorporated company, and flags matters that may affect the company during the process. It also identifies potential issues that may arise for the company as a consequence of this approach. It is not comprehensive, as the specific issues and actions for a share‑sale reorganisation will vary between transactions. For an overview of the key points relevant to an intra‑group reorganisation by asset sale, see: Intra‑group reorganisation (by asset sale)─checklist. Considering a corporate reorganisation may call for specialist input across several disciplines. Please seek further guidance on the following areas where required: Property Employment Pensions Intellectual property Information technology Finance Tax For further information, see Practice Notes: IP and IT aspects of intra‑group...
Issue Guidance This Checklist sets out a concise overview of the principal actions for moving assets within a group from one English-incorporated company to another, and flags particular matters that may affect the company during the process. It is not comprehensive, as the considerations and sequence of steps for an asset-based reorganisation will differ between transactions. For an outline of the main points where a reorganisation is carried out by selling shares, see: Intra-group reorganisation (by share sale)─checklist... Determining the intra-group reorganisation structure and other preliminary considerations (general) Early planning should address whether the reorganisation proceeds by way of an asset transfer or a share deal. For guidance on preparatory work and choosing between an asset or share route, refer to: Intra-group reorganisation—common issues—flowchart and Practice Notes: Common issues in an intra-group reorganisation, Asset sales and...
How to use this Checklist Use this checklist to identify recurring points when preparing long- or short-form IPR licences in an asset purchase. Read with the Intellectual property licence (asset purchase) precedents (long/short). For assignments, see the corresponding precedents and checklist. For particular rights, consult the copyright, design, patent and trade mark precedents and checklists. See Practice Notes on licensing/sub-licensing IPRs, software licensing, know-how, and IP tax. May inform heads of terms; see Heads of terms—commercial contracts. Checklist for proposed licence of intellectual property rights (asset purchase) ( A) Key commercial considerations Parties/relationship: status, authority, beneficiaries/guarantees, arm’s length, contingencies, documents. Timing: start date, term, notice, conditions precedent, early termination and effects. IPRs: types; scope (registered/unregistered, applications, renewals, improvements); exclusions/third-party IPRs; moral rights; ownership; exclusivity; transfer/sub-licensing; territory; use and purpose. Pricing: fees/royalties/expenses; ancillary costs and IPO registrations; VAT/taxes; price changes;...
In brief A company may review its intellectual property portfolio for various purposes, such as stocktaking; bolstering balance sheet asset strength and addressing gaps in asset coverage; valuing and leveraging those rights; spotting threats and reducing the likelihood of disputes; and creating a framework for ongoing IP administration and upkeep. This Checklist sets out the principal points to consider that could emerge in an IP audit and is to be read alongside Precedent: Intellectual property internal audit questionnaire......
Practice Statement ( Companies: Schemes of Arrangement under Part 26 and Part 26A of the Companies Act 2006) ( Practice Statement 2020) Where a company puts forward a restructuring plan to creditors, the Practice Statement 2020 requires it to take every reasonably available step to alert any person affected that the plan is being advanced, explain the aim it seeks to achieve, and outline the creditor meetings the applicant considers will be required and how they are constituted, unless there is proper justification for not doing so (a consultation began in May 2025 intending to replace this Practice Statement by the end of July 2025; see: LNB News 09/05/2025 46). This notification is typically given by sending a practice statement letter to creditors ahead of the convening hearing. What amounts to sufficient notice of the convening hearing turns on the particular facts and...
Undue influence Where a person gives security to support a third-party borrower, a presumption of undue influence may arise in particular situations and, in certain circumstances, be assumed—for details on when this presumption is engaged, see Practice Note: Taking a guarantee or third party security from an individual—undue influence. After the House of Lords ruling in Royal Bank of Scotland v Etridge ( No 2), the Law Society issued guidance for solicitors advising security providers to protect themselves from negligence claims. The judgment itself also explained the means by which a lender may protect itself from third-party security being set aside in circumstances where there is potentially undue influence. Checklist for a lender taking third-party security from an individual To rebut the presumption of undue influence (see above), a lender must be able to demonstrate that the security provider understood the nature of the...
For comprehensive guidance on the incorporation of a private company limited by guarantee, consult Practice Note: Companies limited by guarantee. Matter to be reviewed or action to be undertaken Companies Act 2006 ( CA 2006) citation (where applicable) Tick box when action completed or matter reviewed Preparing to incorporate a private company limited by guarantee Will the company be bespoke on incorporation or obtained ‘off the shelf’? If the company is to be bespoke, proceed with the remainder of this checklist. N/ A Who will be the initial members? A sole member is permitted......
Before commencing the arbitration Check time bars; fit claims; plan measures; arbitrator number; nominations/disclosures; funding disclosure. Emergency measures Apply pre-constitution; before transmission; 15-day order; binding. Expedited Procedure Confirm scope/opt-outs; sole arbitrator; no Terms; streamlined; six-month award. Commencing the arbitration File Request with particulars; arbitration starts on receipt; pay fee. Responding to the arbitration Answer in 30 days; include counterclaims; answer counterclaims in 30 days. Jurisdiction Proceedings continue; raise pleas promptly; prima facie review. Preliminary meeting and directions Terms within 30 days; conference; timetable; efficient management. Written statements File per timetable. Evidence All appropriate means; documents-only unless hearing sought. The hearing Held if requested/ordered; in-person or remote; tribunal schedules; privacy. The award Aim six months; Court scrutiny; notification after costs; final/binding;...
This Checklist offers guidance on how to determine whether an Irish court has jurisdiction to deal with the specific civil dispute. This Checklist explains how to assess jurisdiction for a particular civil dispute in Ireland. In doing so, it reviews the regimes under Brussels I (recast), the Lugano Convention and the Hague Convention on Choice of Court Agreements. It sets out a high-level overview to help decide whether proceedings ought properly to be brought in Ireland. For guidance on: the particular court in which to issue proceedings, see Practice Note: Ireland- Starting a civil action pre-action considerations before pursuing a civil claim in an Irish court, and the steps to commence and advance a claim in Ireland, see Practice Notes: Ireland- Starting a civil action and Ireland- Pre-action conduct; and for initiating and case managing a civil claim, see Ireland-...
This overview sets out and contrasts key provisions of the Companies Act 2006 ( CA 2006) concerning members’ rights at general meetings ( GMs), including annual general meetings ( AGMs). For fuller guidance, see Practice Note: General meetings (including AGMs)—members’ rights. Requisition a GM and include proposed text of a resolution to be moved ( CA 2006, s 303) Applicable companies: All companies. Meeting type: GM. Voting requirement: Minimum 5% of paid-up capital with voting rights at the meeting. Limits: The request must outline the general nature of the business and may set out the wording of a resolution that can properly be proposed. Requests can be sent in hard copy or electronically and must be authenticated. A resolution cannot be moved if it is ineffective, defamatory, frivolous or vexatious. Action: Directors must convene a GM within 21 days, with the...
NOTE : From 1 October 2023, the CPR broadened the reach of fixed recoverable costs. These revisions apply where: the cause of action arises on or after 1 October 2023 (usually the date of the accident), or for disease claims, no letter of claim was sent before 1 October 2023 For the version of CPR 45 that was in force before 1 October 2023, see: Can more than fixed costs be recovered? London weighting A 12.5% uplift applies to fixed costs if the claimant lives or works, and the instructed solicitor practises, within one of the London areas listed in CPR 45. Other circumstances For guidance on additional situations where more than fixed costs might be recoverable, see Practice Note: Fixed costs in employer liability and public liability claims. Children Where the claimant is a child, any settlement reached by the parties must be approved by the court....
This Checklist This Checklist highlights the different avenues for bringing a joint venture ( JV) to a close or facilitating an exit, and the factors to weigh depending on the pathway chosen. For guidance on addressing a JV dispute, see Practice Note: Joint venture disputes—how to respond. For further detailed guidance on terminating joint ventures where a specially created or nominated joint venture company ( JVC) is involved, see the following Practice Notes: Termination—corporate joint ventures Tax implications of operating and terminating a joint venture company Corporate joint venture dispute—dealing with deadlock: initial considerations Majority-minority joint venture dispute—a practical illustration Entering a JV relationship usually calls for significant planning and effort from the JV parties, who opt to work together for mutual advantage (often by sharing cost, resources and expertise). You will need to assess the full...
Who to serve and when The respondent to the application is the Official Receiver or the relevant office-holder, and accordingly the application together with the witness statement must be served on them. Under the Insolvency ( England and Wales) Rules 2016 ( IR 2016), SI 2016/1024, r 22.2, the applicant must give notice of any application for permission to use a prohibited name to the Secretary of State for Business and Trade (the Secretary of State). This notification can be made via the Insolvency Service (for postal and email address details, see Insolvency Service Guidance: Re-use of company names). Rule 22.2 of IR 2016 requires that the Secretary of State receives no less than 14 days’ notice. In practice, however, notice ought to be provided to all interested parties as far ahead of any hearing as possible, in good time, so that the...
Scope and purpose This Checklist outlines the principal points to consider when preparing, assessing or agreeing an equipment hire agreement. Equipment hire agreements are also known as equipment leases, equipment rental, operating leases or finance leases. For simplicity, this Checklist adopts the term equipment hire agreement. It is written from the viewpoint of the hiring customer under the equipment hire agreement. See also the accompanying Precedents: Equipment hire agreement—pro-customer and Equipment hire agreement—pro-supplier. The Checklist highlights matters intended to safeguard the hiring customer’s (or lessee) interests in relation to an equipment hire agreement prepared by the supplier (or lessor) (as is typically the position with equipment hire agreements). Expressions such as ‘lessor’, ‘lessee’, ‘hirer’ and similar can be unclear within these sorts of arrangement. In this Checklist the ‘hiring customer’ or ‘lessee’ is the party taking the equipment on lease, and the...
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 ]...