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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

How to use this Checklist This Checklist aims to flag common issues that emerge during the negotiation and drafting of a publishing agreement. For a model publishing agreement, see Precedent: Publishing agreement—pro-publisher. For more detail on matters raised in this Checklist, consult Practice Notes: Assigning intellectual property rights; Licensing intellectual property rights. Where appropriate, this Checklist can also act as the basis of a simple, non-binding heads of terms. For guidance on doing so, see Precedent: Heads of terms—commercial contracts. The third column can be used to capture observations or comments as the Checklist is completed. Checklist schedule for proposed publishing agreement Checklist Further information Notes (if any) Parties Verify each party’s legal status and consider whether any third parties (such as group affiliates) will benefit from the proposed...

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CHECKLISTS

STOP PRESS: With effect from 24 February 2025, the principal provisions of the Procurement Act 2023 ( PA 2023) are operative. Any procurement initiated on or after that date must follow PA 2023, while procurements started under the earlier regimes—the Public Contracts Regulations 2015 ( PCR 2015), the Utilities Contracts Regulations 2016, the Concession Regulations 2016, and the Defence and Security Public Contracts Regulations 2011—must continue to be procured and managed in line with those rules. Refer to Practice Note: Introduction to the Procurement Act 2023— PA 2023. PCR 2015 as assimilated law PCR 2015 are EU-derived domestic legislation and are therefore treated as assimilated law under sections 2 and 6 of the European Union ( Withdrawal) Act 2018. For practical guidance on the status and interpretation of assimilated law, see Practice Note: Assimilated law......

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CHECKLISTS

This checklist assists you in assessing whether your arrangements and controls support effective compliance with the publicity‑related regulatory duties that govern law firms. Read it alongside the subtopic: Publicity & inducements—law firms, to ensure full context. Publicity obligations under the SRA appear in the SRA Principles, the SRA Code of Conduct for Firms ( Code for Firms), the SRA Code of Conduct for Solicitors ( Code for Solicitors) and the SRA Transparency Rules. These are supported by guidance notes and warning notices issued by the SRA. See also Practice Note: Publicity—law firms for further detail. General Requirement Compulsory or recommended Comments (if any) ☐ Put in place a process to confirm that any publicity concerning your practice aligns with the SRA Principles and is not misleading. See Precedents: Publicity material compliance check—law firms and Publicity material audit form—law firms......

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CHECKLISTS

When starting a charitable public appeal, there is scant, if any, certainty that it will be successful. Accordingly, it is sensible to outline the key matters to be handled at the outset. This checklist aids the practitioner in explaining clearly those potential issues, or it can be passed to the promoters of the appeal to help keep these points front of mind......

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This note provides a checklist of the principal questions to ask, and the actions to take, to meet the requirements of Part 21A of the Companies Act 2006 ( CA 2006) covering people with significant control (the PSC regime). It focuses on keeping a register of PSCs and other registrable relevant legal entities ( RLEs) (the PSC register)... The requirement to report PSC information The PSC regime covers UK incorporated companies limited by shares or guarantee (including community interest companies), limited liability partnerships ( LLPs), unlimited companies, unregistered companies and UK Societas. Owing to the Scottish Partnerships ( Register of People with Significant Control) Regulations 2017, SI 2017/694, it also applies to eligible Scottish partnerships ( Scottish limited partnerships and Scottish qualifying general partnerships). These bodies must update their own registers within 14 days and amend the central record at Companies House within a further 14 days;...

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CHECKLISTS

This Checklist outlines the present rules in CPR 45 on fixed costs and sets them against the earlier Part 45 position as it stood before 1 October 2023. Fixed costs provisions The rules governing fixed costs sit within CPR 45 and CPR PD 45. Other mechanisms that restrict costs appear elsewhere in the CPR and in their associated Practice Directions, which are not addressed here and fall outside the scope of this Checklist......

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CHECKLISTS

This Checklist Outlined here are details of those provisions of the Companies Act 2006 that can be incorporated, excluded or altered by the company's articles of association of a private company limited by shares......

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STOP PRESS: The UK’s prospectus framework still derives from the EU Prospectus Regulation, preserved in domestic law after Brexit as the UK Prospectus Regulation. As part of wider reforms to the UK capital markets and to strengthen the UK’s appeal as a listing venue, this regime has been under review. As a result, the UK Prospectus Regulation will be superseded by the Public Offers and Admission to Trading Regulations 2024 (the POATRs), with the detailed admission-to-trading requirements to be set out in the Financial Conduct Authority ( FCA) admission rules. The FCA issued its final rules ( PS25/9) on 15 July 2025, and they will apply from 19 January 2026. On 17 October 2025, the FCA published Primary Market Bulletin 58 which, among other points, gives guidance on the timing and approval of prospectuses (and supplementary prospectuses), and confirms the removal of Listing...

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The Criminal Justice Act 2003 ( CJA 2003) Under the Criminal Justice Act 2003 ( CJA 2003), a different route for commencing criminal proceedings in England and Wales was established. In place of laying an information before a justice of the peace to obtain a summons securing the defendant’s attendance, this approach requires public prosecutors to issue a written charge and serve it on the defendant and the court, together with a requisition directing the person to attend a magistrates’ court to answer the written charge. See Practice Note: Commencing criminal proceedings—written charge and requisition or single justice procedure notice. Only public prosecutors authorised under CJA 2003, s 29(5) are permitted to commence criminal proceedings by this means. The table below sets out those public prosecutors who must now proceed by using the written charge and requisition or a single justice notice...

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CHECKLISTS

This Checklist is intended to support solicitors advising on private prosecutions, and private prosecutors themselves, by outlining the principal advantages, challenges and pitfalls of private prosecutions, setting these alongside other forms of redress to provide clear illustration of how private prosecutions compare in practice overall. Advantages of bringing a private prosecution Key reasons to select a private prosecution over a public prosecution or a civil fraud claim include: the capacity to commence proceedings in circumstances where public prosecutors decline to act Private prosecutions are frequently commenced when public prosecutors refuse to bring charges against the prospective defendant......

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CHECKLISTS

This flowchart illustrates the process of making a proposed instruction claim under the NEC4 Engineering and Construction Contract It may give the Contractor grounds for extra time to finish the works and/or further payment, where relevant. For a chart clearly setting out the procedure for general compensation events, see Compensation event claims under the NEC4 Engineering and Construction Contract—flowchart. For broader guidance on the NEC compensation framework, refer to Practice Note: NEC contracts—compensation event regime, and for the NEC3 compensation process consult Compensation event claims in the NEC3 Engineering and Construction Contract—flowchart......

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CHECKLISTS

This Table This Table sets out the principal property tax points a purchaser should weigh on an asset purchase and on a share acquisition. For fuller analysis of the matters flagged here in this Table, see the following subtopics: Stamp duty land tax subtopic Scotland: Land and buildings transaction tax subtopic Wales: Land transaction tax subtopic VAT on property subtopic Capital allowances subtopic Direct tax treatment of property ownership subtopic Real estate transactions and tax subtopic The tax consequences on any transaction will differ according to its specific facts and context. The Table highlights the principal areas that might emerge, but it is not comprehensive and is not a complete guide. It is intended to give practitioners a primer on the usual tax themes that can arise......

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Successful delivery depends on having team organisation, governance, and reporting frameworks in place. At project initiation, define the project team’s roles, duties, and structure, and put governance arrangements in motion to steer delivery. The team’s size and configuration will shift according to the project’s scale and complexity. Below are examples of core project team roles with a brief, high-level outline of their responsibilities, as set out below. Role Responsibility Project Board/ Steering Group – Created to lead and direct a project, providing leadership and direction in line with governance arrangements set......

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CHECKLISTS

Provisions relating to setting up a project bank account Clauses covering the creation of a project bank account may sit within the building contract itself, or be set out in a separate project bank account agreement, with enabling provisions included in the building contract. See Practice Note: Introduction to project bank accounts. Those due to be paid from the account will also be required to enter into a trust deed. When reviewing or negotiating project bank account documentation, key considerations include: Which parties will establish the project bank account and be the account holders?......

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CHECKLISTS

This Checklist outlines the current position under the Pre- Action Protocol for professional negligence claims (the ' Protocol'). For general guidance on the Protocol, refer to Practice Note: Professional negligence claims—the pre-action protocol. Read this Checklist alongside Practice Note: Professional negligence claims—pre-action protocol—defendant issues. For assistance with starting a professional negligence claim, with a worked hypothetical set of pleadings and a template precedent particulars of claim, which may help a defendant anticipate what they might face, see: Practice Note: Starting a professional negligence claim—a practical guide Practice Note: Pleading professional negligence claims—worked hypothetical examples Precedent: Particulars of claim—professional negligence claim Professional receiving preliminary notice (professional negligence PAP) You must acknowledge receipt of the preliminary notice within 21 days. When doing so, consider: whether any clarification is needed (rare, as the letter need only give notice)? whether early...

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CHECKLISTS

Checklist This Checklist sets out the key considerations when judging if a professional negligence claim can properly be advanced in relation to the scope of the duty, causation and remoteness. It is aimed at deciding whether the losses alleged fall within the professional’s duty by applying the analysis model set out by the Supreme Court in its 2021 rulings in Manchester Building Society v Grant Thornton and Khan v Meadows. For comprehensive guidance on causation and remoteness in this field, see Practice Note: Causation and remoteness in professional negligence claims. Note: in Armstead v Royal & Sun Alliance, the Supreme Court rejected the Court of Appeal’s use of a six-point checklist when assessing whether a claimant car-hirer could recover sums payable to the hire company for loss of use after third-party negligence damaged the vehicle—the issue in that case did not concern the scope of duty, so a...

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CHECKLISTS

This checklist outlines the current position under the Pre- Action Protocol for Professional Negligence claims (the ‘ Protocol’). For general guidance, see Practice Note: Professional negligence claims—the pre-action protocol. Read alongside Practice Note: Professional negligence claims—pre-action protocol—claimant issues. For further detail on pursuing a professional negligence claim (including a worked hypothetical set of pleadings), see: Starting a professional negligence claim—a practical guide Pleading professional negligence claims—worked hypothetical examples Together with the template Precedent: Particulars of claim—professional negligence claim. Client’s initial instructions of potential professional negligence claim Limitation See Practice Note: Limitation—professional negligence claims. Is a limitation issue pending? If so: consider issuing protective proceedings negotiate a standstill agreement See Practice Note: Professional negligence claims—the pre-action protocol— Limitation and the professional negligence PAP. Initial investigations background basis of claim (in contract, tort, etc) any obvious difficulties with causation ...

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CHECKLISTS

ARCHIVED: This checklist has been archived and is not maintained. Insured party name Name Prospective claimant name Name Policy reference Policy number Policy term Policy period Earlier policies Previous policies Date of notification Date Is the person or entity making the notice on the policy schedule, or in the proposal?......

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CHECKLISTS

This Checklist This Checklist outlines the principal points a business should weigh up when confronting a product safety issue. It explains what to build into systems for managing product liability exposure in this field, with reference to the Code of Practice on Product recalls and other corrective actions ( PAS 7100:2022). Pinpoint all applicable laws (eg Sale of Goods Act 1979, Sale and Supply of Goods Act 1994, Consumer Protection Act 1987, General Product Safety Regulations 2005 ( GPSR 2005), SI 2005/1803, Consumer Rights Act 2015, Digital Markets, Competition and Consumers Act 2024), standards, and codes of practice (eg Code of Practice on Product recalls and other corrective actions ( PAS 7100:2022) and Code of Practice on Bringing Safe Products to the Market ( PAS 7050:2022)) that govern the products. See Practice Notes: Consumer protection for defective or dangerous...

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CHECKLISTS

Checklist This Checklist outlines the key considerations when addressing a product liability or consumer safety issue that calls for corrective action, such as a product recall. When assessing corrective measures connected to a product liability or safety matter, it is prudent to consult the government-backed BSI standards— PAS 7050:2022, Bringing safe products to the market— Code of practice, and PAS 7100:2022, Product recall and other corrective actions— Code of practice. Although the guidance in the Codes is not legally binding, they are supported by the Office for Product Safety and Standards ( OPSS)— OPSS/market surveillance authorities are likely to refer to the recommendations in the Codes when dealing with product safety issues. Pinpoint the specific products implicated (and, if feasible, whether only particular batches or date codes are in scope) and confirm the jurisdictions to which the affected products were...

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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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