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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 highlights the key points to consider when negotiating or drafting a settlement agreement to conclude an IP dispute at either the pre-action stage or after proceedings have started. It is intended to draw attention to issues commonly encountered during the negotiation and drafting of the following: Settlement agreement— IP dispute—short form Draft Settlement agreement—pre-action settlement Draft Settlement agreement—for settling disputes post-commencement of proceedings For more on resolving an IP dispute, see Practice Note: How to settle an IP dispute. Where appropriate, this Checklist can also act as the basis for straightforward, non-binding heads of terms. For guidance, see Precedent: Heads of terms—commercial contracts. Checklist for proposed settlement agreement The third column can be used to capture observations or comments as you work through the Checklist. When negotiating and drafting the settlement agreement, ensure you consider key...

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CHECKLISTS

Number and identity of the partners What is the total number of partners, and who are they? In what capacity does each participate—individual, company, another partnership, or other entity/body? Who will act as general partner(s) and who as limited partner(s)? Can additional limited partners be admitted, and if so, on what terms? May limited partners hold other business interests and undertake activities beyond the limited partnership, including interests and activities in direct competition with it? Business details What activities will the limited partnership undertake? Is it an ongoing enterprise or a one-off project or series of projects? Are any regulatory consents, approvals, and licences required for the intended business? What name will the limited partnership trade under? Does the chosen name conflict with any registered limited partnership or business name? Carry out...

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CHECKLISTS

This checklist outlines the main points to address when establishing a limited liability partnership ( LLP), covering legal, regulatory and practical considerations. Number and identity of the members How many members will there be, and who are they? Eligibility: a member must not be an undischarged bankrupt, nor disqualified from acting as an LLP member or a company director. Capacity of each member: individual, company, other entity or body. For individuals, provide: full name and any former business name(s) used within the previous 20 years usual residential address (plus any CA 2006, s 243 exemption from disclosure to credit reference agencies as it applies to LLPs) service address (this can be the LLP’s registered office) country or state of...

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CHECKLISTS

Number and identity of the partners How many partners will there be, and who are they? What is each partner’s status: individual, company, another partnership, or other entity/body? Do all partners possess the requisite qualifications? Will any be salaried or fixed‑share partners? What rights and duties will they hold? Will they sign and be bound by the partnership agreement? Can new partners be brought in; if so, must they sign a deed of adherence? Is unanimous approval required to admit new partners? Business details What activities will the partnership undertake? Is it an ongoing venture or a one‑off project (or projects)? Are any regulatory consents, approvals and licences needed? What will the partnership be called; does the name clash with an existing one? Carry out searches at Companies House and the Trade Marks...

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CHECKLISTS

Practice Note: VAT place of supply rules—special rules for services This table should be read in tandem and considered together with Practice Note: VAT place of supply rules—special rules for services. The services shown are within a special rule—ie an exception to the general rule—that determines their VAT place of supply for VAT purposes. The second column provides links to the section of the Practice Note that sets out the rule applying to the relevant service. In some situations, a service is only brought within a special rule in certain defined circumstances (eg where the supply is B2B or B2C); where appropriate, the Practice Note gives the explanation in further detail......

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CHECKLISTS

Introduction This checklist sits alongside the more detailed Practice Note: Negotiation guide—services agreements. It serves as a quick-look aide and concentrates on the principal, generic points that commonly surface across most forms of services agreement. It leaves out certain specialist matters addressed in Practice Note: Negotiation guide—services agreements that tend to arise only in particular categories of services arrangements or those of greater complexity (eg acceptance testing, audit rights, TUPE, step-in rights, benchmarking and exit assistance). It sets out the customer’s and the supplier’s optimal stances for each topic, then offers a proposed middle-ground position (which is not intended to be comprehensive). For deeper analysis and explanation of each point, refer to Practice Note: Negotiation guide—services agreements. For balanced precedent contracts, which implement much of what is explored here and in the negotiation guide, see Precedents: Services...

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CHECKLISTS

This Checklist outlines the Sentencing Council’s guidance for corporate money laundering offences, which can be accessed here. The Council also issues a set of overarching guidelines to be applied to all sentencing exercises. These include: Sentencing Guideline— Totality General guideline—overarching principles Sentencing Guideline— Reduction in sentence for a guilty plea For more detail, see Practice Note: Sentences imposed following conviction. Among these, the General guideline: overarching principles (the General guideline) is designed to be read alongside offence specific guidelines. It addresses seriousness and provides expanded explanations of aggravating and mitigating factors, culpability and harm; see Practice Note: Sentencing Council General Guideline: Overarching Principles— Using the General Guideline in conjunction with offence specific definitive guidelines. See also, Practice Note: Sentencing criminal offences—sentencing guidelines and resources. Money laundering committed by a corporate offender The maximum sentence for money laundering under sections 327, 328 and 329 of the...

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CHECKLISTS

This Checklist summarises the Sentencing Council’s guidelines for sentencing corporate offences of fraud under the Fraud Act 2006 ( Fr A 2006), Theft Act 1968 ( TA 1968), Value Added Tax Act 1994 ( VATA 1994) and Customs and Excise Management Act 1979 ( CEMA 1979) in the Crown Court and magistrates’ court This Checklist outlines the Sentencing Council’s approach to sentencing corporate fraud offences under Fr A 2006, TA 1968, VATA 1994 and CEMA 1979 in the Crown Court and magistrates’ court. The Fraud Guidelines for corporate offenders are available here. The Sentencing Council also issues overarching guidance to be considered in all sentencing decisions, including: Totality guideline Overarching principles Overarching guideline on reduction in sentence for a guilty plea For guidance on using guidelines, see Practice Notes: Sentencing criminal...

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CHECKLISTS

Statutory purpose of sentencing—application to companies The aims of sentencing, as set out in section 57 of the Sentencing Act 2020 ( SA 2020), apply in identical terms to companies and to individuals. In deciding the sentence for a corporate offender, the court will have regard to the following purposes: punishing offenders reducing crime reforming and rehabilitating offenders protecting the public, including victims of crime ensuring offenders make reparation to those affected by their offences These purposes inform and shape the court’s choice of sanction for a company. Seriousness of the offence The court must determine the gravity of the offence by reference to the factors listed in SA 2020, s 63, namely: the offender’s culpability in committing the offence; and any harm the offence caused, was intended to cause, or could reasonably have been...

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CHECKLISTS

FCA and PRA senior management arrangements, systems and controls requirements The Financial Conduct Authority’s ( FCA) expectations for senior management arrangements, systems and controls are outlined in the Senior Management Arrangements, Systems and Controls sourcebook ( SYSC) within the FCA Handbook, as set out in SYSC. For the Prudential Regulation Authority ( PRA), equivalent obligations appear across sections of the PRA Rulebook and in PRA Supervisory Statements ( SSs). This checklist offers a mapping of the requirements in the various SYSC chapters alongside the corresponding senior management arrangements, systems and controls provisions contained in the PRA Rulebook and SSs. The mapping links each SYSC chapter to the parallel PRA materials. Details of the entities within the scope of SYSC are summarised in SYSC 1.1A.1G, and set out in full in SYSC 1 Annex 1 and in the relevant SYSC chapter......

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CHECKLISTS

By virtue of Schedule 46 to the Finance Act 2009 ( FA 2009), the senior accounting officer ( SAO) regime was brought in to make sure qualifying companies keep adequate tax accounting arrangements in place, so that the correct tax liabilities are provided to HMRC. The regime applies to financial years commencing on or after 21 July 2009......

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CHECKLISTS

ARCHIVED: This Checklist is archived and no longer maintained. Brexit: From exit day (11 pm on 31 January 2020), the UK ceased to be an EU Member State. Nonetheless, under the Withdrawal Agreement, the UK entered an implementation period during which EU law continues to apply, which affects this Checklist. For additional guidance, refer to Brexit Bulletin—key updates, research tips and resources, and the Brexit collection. On 3 February 2020, the UK and the EU published initial negotiating stances on a future UK- EU relationship after Brexit. Although the Political Declaration, which accompanies the Withdrawal Agreement, outlines the framework for future ties with the EU, it is not legally binding, so either party may decide to deviate from parts or all of it, and outcomes could therefore differ from that text. If talks on a UK- EU trade agreement fail (a no trade deal...

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CHECKLISTS

This Checklist This Checklist provides a reference to selected critical points for the seller’s lawyers to assess when preparing or reviewing a share purchase agreement ( SPA, or share sale agreement) documenting the transfer of all issued share capital in a private limited company, in circumstances where the deal features exchange and completion happening concurrently within a single, combined timetable......

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CHECKLISTS

This Checklist This Checklist acts as a guide to specific core issues the seller’s solicitors should review when preparing or marking up a share purchase agreement (also referred to as an SPA or share sale agreement) documenting the sale and acquisition of the whole issued share capital of a private limited company, in transactions featuring split exchange and completion......

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CHECKLISTS

This Checklist This Checklist sets out the searches to be carried out and the principal questions to address when reviewing security granted in favour of a lender to support a company’s borrowings. It is intended for use where the borrower is a limited company incorporated and registered in England and Wales. The Checklist should be used together with the Precedent: Security review report, which provides the framework for presenting the outcome of your security review. In addition, the guidance in the Practice Note: Introductory guide to security reviews may prove useful when completing this Checklist. Be aware that some lenders prescribe in detail how a security review is to be undertaken—for example, which searches must be performed, the timing of those searches, whether original or copy documents are to be examined, and the format required for the final report—so you should tailor this...

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CHECKLISTS

ARCHIVED: This document is archived and is no longer being updated. Regulation ( EU) 2017/2402 (the EU Securitisation Regulation) took effect on 18 January 2018 and has applied across the EU since 1 January 2019. From IP completion day (31 December 2021), Assimilated Regulation ( EU) 2017/2402 (the UK Securitisation Regulation) has applied in the UK. This Checklist describes the due diligence, risk assessment and ongoing monitoring duties that apply to institutional investors in: the EU, under the EU Securitisation Regulation; and the UK, under the UK Securitisation Regulation. For general information on the EU and UK securitisation regimes, see Practice Notes: UK Securitisation Regulation—essentials [ Archived], UK regulatory capital treatment of securitisations under CRR and Solvency II and Legislation guide for transactional lawyers— UK Securitisation Regulation [ Archived], the STS securitisation criteria—checklist [ Archived] and the EU and UK...

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CHECKLISTS

ARCHIVED: This Practice Note is archived and is no longer maintained. This Timeline charts the proposal for the Securities Financing Transactions Regulation and the ensuing EU and UK developments concerning the Regulation. Within the EU, the European Commission undertook extensive work on shadow banking, culminating in its September 2013 Communication on Shadow Banking. Among its priorities was boosting transparency around securities financing transactions ( SFTs). It also called for improvements to the regulatory framework for investment funds, including undertakings for collective investment in transferable securities ( UCITS) and alternative investment funds ( AIFs) (see Practice Notes: Undertakings for Collective Investment in Transferable Securities—essentials and UK regulation of alternative investment fund managers—essentials for further information). The EU Regulation on reporting and transparency of securities financing transactions, Regulation ( EU) 2015/2365 (the EU SFTR), represents the Commission’s legislative response to the issues...

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CHECKLISTS

This Checklist outlines the principal risks and points to weigh when taking steps to build a resilient supply chain, covering demand, communication, mapping, supplier requirements, contingency plans, supplier agreements, supplier distress and insolvency, fraud, and de‑risking. It accompanies Practice Note: Securing a resilient supply chain. Demand In relation to demand, have you: Evaluated the possible effects of a major supply chain event (eg geopolitical instability, a pandemic, or product shortages) on your customers/end users? Considered how a significant supply chain event could influence your distribution network and adjusted it as necessary? Assessed whether investing in technology (eg AI, digital twins, crisis and scenario modelling) could deliver solutions to sharp changes in supply and demand? Communication In relation to communication, have you: Kept strong, regular dialogue with key suppliers, logistics partners and end customers about what you are doing and the steps you are...

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CHECKLISTS

Once the accused has served a defence statement and the prosecutor has either complied, purported to comply or failed to comply with obligations that govern further disclosure, the defendant may apply to the court, pursuant to section 8 of the Criminal Procedure and Investigations Act 1996 ( CPIA 1996), for an order obliging the prosecutor to reveal material where there is reasonable cause to believe there exists prosecution material that meets the disclosure test. The Criminal Procedure Rules 2025 ( Crim PR 2025), SI 2025/909, set out the form and procedure that must be observed for such applications......

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CHECKLISTS

To bring a business tenancy to an end on the contractual expiry date or at any point thereafter, a tenant may rely on a notice given under section 27 of the Landlord and Tenant Act 1954 ( LTA 1954). This Checklist sets out the circumstances and procedure for serving such a notice. For wider guidance on ending LTA 1954 tenancies, refer to Practice Note: LTA 1954 business lease renewal—termination. It outlines timing and the method of service in clear terms. Is the tenancy for a fixed term? A section 27 notice is available only where the tenancy is for a fixed term. It is not available for periodic tenancies. Nevertheless, a tenant may end a periodic tenancy by giving a common law notice to quit (see Practice Note: LTA 1954 business lease renewal—termination under the heading Termination of LTA 1954...

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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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