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
Businesses make broad use of social media as a marketing instrument. This Checklist is intended to assist law firms in deciding whether you have suitable systems in place to comply with relevant legislation and regulation concerning social media. For more detailed guidance and additional resources, see subtopic: Electronic workplace. Required document or action Do you have a written policy that sets out both permitted and prohibited social media use (eg see Precedent: Policy—social media (short form))? Does your social media policy also cover the use of the internet and electronic communications? ......
SM& CR Compliance— Checklist Note: On 15 July 2025, the government announced the Leeds Reforms, which include plans to streamline the SM& CR. At the same time, the PRA and FCA published consultation papers CP18/25 and CP25/21. The regulators propose a two-stage reform, with Phase Two to follow, subject to legislative changes under HM Treasury consultation. Final Phase One requirements are expected mid-2026, with any Phase Two consultations dependent on HMT legislation. See News Analysis: Reform of the SM& CR— Proposals and next steps. Overview The Senior Managers and Certification Regime ( SM& CR) is the UK framework governing individuals working in financial services. It aims to widen personal liability, prioritising senior management accountability and fostering a firm-wide culture of responsibility to reduce consumer harm and reinforce market integrity. The regime comprises: Senior Managers Regime ( SMR) – ensures Senior Managers can be held to account for...
SM& CR Checklist— SMF approvals: what to do when things go wrong The Senior Managers & Certification Regime ( SM& CR) obliges authorised firms to seek approval from the Financial Conduct Authority ( FCA) and/or the Prudential Regulatory Authority ( PRA) before appointing an individual to carry out a senior manager function ( SMF). As part of that process, the regulator may invite the candidate to interview. Interviews are discretionary rather than a standard step in the SMF approval pathway. This Checklist supports SMF candidates and their firms (which submit the SMF application on the candidate’s behalf) in spotting, managing and responding to issues that arise during an SMF interview or after it, including receipt of a ‘minded to refuse’ letter or a decision by the regulator(s) to refuse the application. This Checklist should be read in conjunction with: SM& CR...
SM& CR Checklist—preparing for SMF interviews This Checklist helps candidates get ready for interviews with the Financial Conduct Authority ( FCA) and/or the Prudential Regulatory Authority ( PRA) for approval to carry out a senior manager function ( SMF) under the UK regulators’ Senior Managers & Certification Regime ( SM& CR). Under the SM& CR, firms must seek regulatory approval when proposing to appoint someone to an SMF. During this process, the individual might be invited to interview by the regulators. Such interviews are run by a panel, featuring representatives from the regulators’ authorisations and supervisory teams. Interviews are not routine for every SMF application and, when arranged, are targeted by risk and tailored to the role. The scope and intensity of the questions will shift according to the SMF in scope, the firm’s risk profile, and the candidate’s experience. For instance,...
This Flowchart Sets out the steps for the small claims mediation service (for matters moving on the small claims track) in line with CPR 26.6, CPR 26.7(3) and CPR 26.9......
This Checklist explains the layout a skeleton argument ought to adopt and gives an overview of material required, together with practical considerations to bear in mind. Read it with Practice Note: Skeleton arguments. Details of a skeleton’s structure and substance will also vary depending on the court in which the claim is progressing, and local requirements should be checked. For more detail, see Practice Note: Skeleton arguments— Court specific guidance. The CPR include guidance on skeleton arguments intended for use in appeals; however, that guidance is of general assistance and not confined solely to appeal work. For those provisions, please consult the Practice Note: Skeleton Arguments in an appeal—general provisions. Structure Content Example/ practical points to consider Heading State what the document comprises and identify the party you represent. If there is more than one skeleton argument in the proceedings—for example, where skeletons were filed for earlier...
A share incentive plan ( SIP) enables employees to obtain shares in their employer, or a parent company of the employer, in a tax‑efficient manner, under a statutory scheme. The legislative framework for SIPs is found primarily in the following provisions: Schedule 2 to the Income Tax ( Earnings and Pensions) Act 2003 ( ITEPA 2003), which describes how a SIP can be run and the principal conditions that must be met for the SIP to be a ‘ Schedule 2 SIP’; ITEPA 2003, Pt 6 Ch 7 ( ITEPA 2003, ss 488–515), which sets out the income tax treatment of shares obtained under a SIP. For more general background and context on SIPs, see Practice Note: What is a SIP? Set out below is a checklist of the key matters to consider before establishing or operating a SIP. It proceeds on the basis that the SIP...
ARCHIVED: Checklist This archived Checklist outlines factors to bear in mind when advancing a matter before the Singapore International Commercial Court ( SICC), covering pre-action and the commencement of proceedings. It is not maintained and is supplied for background information only. Pre-action Select your chosen ‘counsel’. Permissible options are: an advocate and solicitor; a person admitted to practise as an advocate and solicitor under section 15 of the Legal Profession Act ( Cap 161) (an ad hoc admission); a foreign lawyer holding full registration under Legal Profession Act ( Cap 161), s 36P. A foreign lawyer with the alternative ‘restricted registration’ may only undertake what is allowed by Legal Profession Act ( Cap 161), s 36P(2). ...
This checklist sets out what a company listed in the equity shares (commercial companies) category must announce to a regulatory information service ( RIS) in relation to a significant transaction under UKLR 7.3 of the UK Listing Rules. Under the UKLR, a significant transaction is one where any percentage ratio reaches 25% or more. Initial disclosure requirements— UKLR 7.3.1R The following must be notified to a RIS as soon as the terms of a significant transaction are agreed: UKLR 7.3.1R (2)(a): A statement setting out why the transaction is notifiable under UKLR 7. UKLR 7.2.13G (4): If the notice concerns aggregated transactions, an explanation of the basis for aggregation, with reference to whether UKLR 7.2.11R (1)(a), (1)(b) or (1)(c) applies. UKLR 7.3.1R (2)(b): A summary of the transaction and the company’s rationale for undertaking it, including the items below. UKLR 7 Annex 2, 1.1 R...
Before commencing the arbitration Check limits; confirm SIAC clause; interim relief; tribunal size; proper nominations. Emergency measures Seek Emergency Arbitrator pre-constitution; urgent, Registrar-approved, binding relief. Expedited Procedure Apply pre-constitution; expect sole arbitrator, streamlined process, six‑month award. Commencing the arbitration Serve Notice on Registrar/respondent with required particulars, funding statement, fee. Responding to the arbitration Respond within 14 days; address claims, jurisdiction and counterclaims. Jurisdiction Arbitration proceeds unless screened; tribunal rules; object under Rule 31. Preliminary meeting and directions Attend administrative calls; hold early case management conference. Written statements File Claim, Defence, Counterclaim as directed; state facts, grounds, relief. Evidence Tribunal controls evidence; written testimony allowed; oral examination on request. The hearing Any party may request; tribunal sets format and privacy. The award Written, reasoned, signed; deemed at seat; final; correction/interpretation/additional award windows. Costs Registrar fixes costs; tribunal allocates and may order security; deposits shared. ......
Flowchart To prove a fraudulent trading claim, this Flowchart summarises the criteria that must all be met...
Flowchart This Flowchart outlines the requirements that need to be met for the court to determine that a transaction is an extortionate credit transaction and award relief. It should be consulted alongside Practice Note: Extortionate credit transactions—corporate and personal insolvency......
This flowchart outlines the various stages of a UK anti-dumping investigation, initiated when the Trade Remedies Authority ( TRA) accepts an application for the imposition of anti-dumping duties......
Checklist This Checklist outlines the IP matters that commonly require attention when drafting share purchase agreements ( SPAs). It also considers points to address when carrying out the related IP due diligence and structuring around such transactions. For information on the corporate elements of these deals, see: Share purchase agreement—overview. For guidance on key provisions and issues relating to IP in the context of a share purchase, see Practice Note: IP issues to consider in share purchase contracts. For information about IP due diligence, see: Precedent: IP due diligence questionnaire; and Checklist: Intellectual property due diligence in share purchase transactions—checklist This Checklist covers technology only to a limited degree. If IT represents a principal asset of the target company, more detailed warranties should be included in respect of, eg, IT systems and core software......
Checklist of key tax considerations relevant to share issues Structured as a table, this checklist clearly outlines key tax considerations specifically in respect of share issues......
A share incentive plan ( SIP) A share incentive plan ( SIP) permits companies that satisfy SIP eligibility criteria to grant tax-favoured share awards to all employees. The shares are required to be held by a trustee resident in the UK. Under a SIP, awards can comprise four categories in total: free shares, partnership shares, matching shares, and dividend shares......
Share incentive plan ( SIP) A SIP lets companies that satisfy the scheme’s eligibility rules offer tax-advantaged share awards on an all-employee basis. The shares must be held and administered by a trustee who is resident in the UK. Within a SIP, four award types are available in total: free shares, partnership shares, matching shares and dividend shares......
Any resolution of a dispute should be set out in a signed, enforceable written agreement that precisely records the parties’ terms. This reduces the prospect of later misunderstanding and allows a party to commence proceedings if the other side does not comply. As the agreement is a contract, contract law governs its drafting and interpretation, so it must be written with clarity. This Checklist highlights the key considerations of particular importance to construction disputes. For illustrative clauses and deeper analysis (including drafting notes), see Precedent: Settlement agreement for construction dispute (long form). Ensure that settlement negotiations are conducted on a without prejudice basis State expressly that settlement discussions are conducted on a ‘without prejudice’ basis so that, if talks fail, any proposed concessions cannot be relied upon by the other party in subsequent legal proceedings. Do not assume that terms such as...
Claims can be settled at any point in the litigation process This can occur pre-action and during proceedings. From the outset, practitioners should carefully and repeatedly assess the scope for compromise. Securing an early, proportionate agreement is a laudable aim to keep under consistent review. Regard Part 36 as a vital mechanism because its cost consequences concentrate minds. Consider the following questions: • ......
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 ]...