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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

A letter of intent ( LOI) can be put in place before the formal agreement and signing of a building contract (or sub‑contract) so that certain design tasks and/or works may commence at an early stage as necessary and appropriate. This Checklist outlines the principal points a contractor should weigh and the drafting it ought to seek, or ask to be inserted, to secure a clear, binding letter of intent on a construction project. Although the terms ‘contractor’ and ‘employer’ are used, the same principles also apply to dealings between a contractor and a sub‑contractor. When negotiating or preparing a letter of intent, not every point listed below will be pertinent; users must assess each matter against the particular circumstances. See Practice Note: Letters of intent—construction for further guidance on letters of intent. Key issues and clauses Are the parties’ particulars fully and...

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CHECKLISTS

Legal operations risks This section addresses risks stemming from the operation of the legal department overall...

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CHECKLISTS

Explaining LPP to colleagues Make sure you can clearly define what privilege means for colleagues, outlining how it operates and what is required. See Precedents: Legal professional privilege—quick guide for staff and Legal professional privilege—top ten tips. [ Insert comment or action] Document creation/dissemination Advise colleagues to avoid drafting and sharing documents unless genuinely necessary. See Precedents: Legal professional privilege—quick guide for staff and Legal professional privilege—top ten tips. [ Insert comment or action] Consider prohibiting the use of email to circulate legally privileged materials. See Precedents: Legal professional privilege—quick guide for staff and Legal professional privilege—top ten tips. [ Insert comment or action] Remind staff not to mention legal advice or other privileged content in emails, except where...

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CHECKLISTS

This Checklist sets out privilege considerations when interviewing witnesses or gathering background to a dispute, including when legal professional privilege ( LPP) may apply. It gives guidance on conducting witness interviews, how to record interview notes to preserve privilege, and managing investigations, for instance in the context of a Serious Fraud Office ( SFO) investigation... Privilege When speaking to potential witnesses or assembling background material, an interviewer’s notes may attract LPP, in the form of: legal advice privilege—confidential communications between legal advisers and their clients made for the purpose of giving or receiving legal advice on the prudent and sensible course in the relevant legal context ( Balabel, Taylor LJ) litigation privilege—confidential communications between (1) legal advisers or their clients and (2) third parties, where the sole or dominant purpose of the communication relates to existing or contemplated...

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CHECKLISTS

Trustee in trust deed for creditors Authority to sell or lease must be expressly stated within the trust deed for creditors. If absent, recourse is to statutory powers under: section 4 of the Trusts ( Scotland) Act 1921 section 2 of the Trusts ( Scotland) Act 1961 Interim trustee in bankruptcy An interim trustee in bankruptcy lacks authority to contract, sell, or lease unless the court has specifically granted that power......

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CHECKLISTS

When taking a lease or a transfer from an administrative receiver, the title deeds should include the original debenture, or a certified copy, under which the receiver was appointed a certificate from the chargee (or their conveyancer) confirming the power of appointment under the debenture has arisen the original deed appointing the receiver, or a certified copy a certified copy of the receiver’s notice accepting the appointment (the original is retained by the chargee) HM Land Registry will need all of the above to register the lease or transfer. Although the debenture is usually noted against the property title, HM Land Registry will also verify that it: has been registered at Companies House has been duly executed contains provisions permitting the receiver’s appointment and the proposed...

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CHECKLISTS

Checklist This Checklist outlines the actions and key timeframes a tenant must follow when serving a notice of claim under the Leasehold Reform, Housing and Urban Development Act 1993 ( LRHUDA 1993). It addresses the landlord’s section 45 counter-notice, including whether the claim is accepted or rejected and any opposition based on an intention to redevelop. It also sets out the deadlines for applying to the First-tier Tribunal ( FTT) — or the Leasehold Valuation Tribunal ( LVT) in Wales — to determine terms where agreement cannot be reached, and for commencing County Court proceedings if the lease is not completed within the statutory period once terms have been agreed or determined. For guidance on the steps required of a landlord, see: Lease extension of flats under LRHUDA 1993 (preparation and procedure) for...

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CHECKLISTS

Checklist This Checklist outlines the considerations and actions a landlord must take, together with the relevant timings and cut-off dates for those actions, after a tenant issues a request for information and/or serves a notice of claim under the Leasehold Reform, Housing and Urban Development Act 1993 ( LRHUDA 1993). Matters covered include serving a landlord’s section 45 counter-notice, deciding whether to admit the claim or dispute it on the ground of an intention to redevelop, and time limits for applying to the First-tier Tribunal ( FTT) (or, in Wales, the Leasehold Valuation Tribunal ( LVT)) to determine terms where agreement is impossible, and/or to the County Court if completion of the lease has not occurred within the statutory period after terms are agreed or determined. For guidance in relation to the steps to be taken by a tenant, see: Lease extension of flats under...

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CHECKLISTS

ARCHIVED This Flowchart is archived and is no longer maintained. FORTHCOMING CHANGE On 11 August 2020, the LCIA released the 2020 edition of its Arbitration Rules, which take effect on 1 October 2020 (the LCIA Rules 2020). These apply to all arbitrations begun on and after that date. A new set of Practice Notes for the LCIA Rules 2020 is in preparation......

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CHECKLISTS

Before commencing the arbitration Review any relevant limitation periods that dictate when the claim must be filed in time accordingly Appraise the claims you plan to pursue in LCIA arbitration and confirm they fall squarely within the arbitration agreement sending the dispute to arbitration Identify where the award is expected to be enforced and consider measures to safeguard assets, for example seeking a freezing order potentially Choose nominees for constituting the tribunal as appropriate......

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CHECKLISTS

Key reading for lawyers attending s 2 interviews The Serious Fraud Office ( SFO) is empowered to compel interviews with persons thought to hold information pertinent to an investigation, by issuing a notice under section 2 of the Criminal Justice Act 1987 (section 2 interviews). For comprehensive guidance on this power and the practical issues it creates, refer to: Interviews under the Criminal Justice Act 1987, s 2 For additional resources relevant to attending interviews under caution and those conducted at the police station, see: Attendance at the police station—checklist Attendance at a corporate crime interview under caution—checklist As the Police and Criminal Evidence Act 1984 ( PACE 1984) does not apply to s 2 interviews, there is therefore no statutory right for an interviewee to have legal representation. It is consequently vital that criminal practitioners are familiar with the SFO guidance for...

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CHECKLISTS

This Checklist sets out the matters to address when organising a mediation once the parties have agreed to mediate or the court has directed it. It covers three phases: arranging the mediation the period immediately before the mediation what is required at the mediation Arranging the mediation The form of mediation — Explore and agree with your client whether the session should be held in person, by phone, or ‘online’, i.e. remotely via video conferencing. See: Remote access mediation—checklist The mediator — Nominate and appoint a mediator. See Practice Note: Choosing a mediator The mediation fees / expenses — Confirm fees and expenses with the mediator; these are commonly apportioned between the parties. See Practice Note: Mediation costs—liability and recovery The mediation agreement — Settle the mediation agreement terms with the other...

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CHECKLISTS

This Checklist outlines the steps for registering a transfer of registered land (freehold or leasehold), or granting a new lease carved out of a registered title at HM Land Registry, covering when to submit the application, the correct HM Land Registry form to complete, and the procedure when HM Land Registry issue any requisitions arising. Is the transfer or lease a registrable disposition?......

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CHECKLISTS

This Checklist sets out HM Land Registry’s rules for first registration of title on the transfer of a freehold or leasehold estate, the grant of a fresh lease, or the creation of a first legal mortgage. It explains which dealings trigger first registration, the period allowed for registration, the results of failing to apply, and the particulars that must be supplied to HM Land Registry with the application... Which dispositions trigger first registration? The following dealings give rise to compulsory first registration. Transfers of unregistered freehold and leasehold estates The transfer or assignment of: an unregistered freehold estate in land; and an unregistered leasehold estate in land with more than seven years remaining at the date of assignment, whether for valuable or other consideration, by way of gift, or in pursuance of an order of any court. An instrument at a negative value is still treated as being for...

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CHECKLISTS

This Checklist sets out the matters a landlord ought to weigh up where a tenant faces insolvency, highlighting the options open to the landlord, such as Commercial Rent Arrears Recovery ( CRAR), forfeiture, drawing on a rent deposit, and pursuing former tenants, guarantors and sub-tenants. It further addresses practical considerations for the landlord, including steps for securing and marketing the property, and contacting the insolvency practitioner. What type of insolvency scenario applies to the tenant? The remedies that can be exercised, and the limits that will bite, differ depending on the particular insolvency arrangement affecting the tenant. Each procedure brings distinct constraints and options. For a table summarising the restrictions, see Practice Note: Quick guide to landlord’s remedies in tenant insolvency. Has contact been made with the insolvency practitioner? It is vital to liaise with the relevant insolvency practitioner to assess the tenant’s position and to...

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CHECKLISTS

A landlord’s development programme can impact occupants, whether within the premises or on adjacent land. This checklist outlines suggested steps a landlord might take before and during development works, to help minimise potential claims by tenants arising from disruption. What should the landlord do before development starts? The landlord should carefully gauge the potential for dispute by: obtaining a thorough grasp of the planned works programme, covering the physical extent of the works, the site facilities contractors will require, the anticipated timeframe for the project, and the likelihood of noise and dust reviewing the occupational leases in detail: whether the works intrude upon any demised premises. See Practice Notes: Airspace development—guidance for landlords and developers, and Alterations outside the demise— Definition of demised premises if any easements cannot be...

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CHECKLISTS

At first glance, a Scots law building contract, professional appointment or collateral warranty will seem much like its English law counterpart to any experienced practitioner. Look more closely, though, and you will find a range of subtle but significant distinctions that merit attention. This Checklist sets out practical pointers for converting an English law construction contract into one that complies with Scots law (often referred to as ‘kilting’ a contract). It is not comprehensive and proceeds on the basis that the parties are using standard mid-market construction forms without extensive project-specific drafting. Where such bespoke drafting is included, further divergences between Scots and English law may need to be considered. Execution issues There is no concept of ‘execution as a deed’ under Scots law. Scots law documents are ordinarily signed in ‘self-proving’ form pursuant to the Requirements of Writing ( Scotland) Act 1995. They are not...

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CHECKLISTS

The Financial Services Enforcement Database Holds comprehensive details on all material Financial Conduct Authority ( FCA) and Prudential Regulation Authority ( PRA) Final Notices and, where available, Decision Notices, covering the period from 2014 to the present. It further includes any Decision Notices issued by the Payment Systems Regulator ( PSR). Beyond enabling filtering by rule contravention, the Enforcement Database also permits users to refine and tailor results more precisely by sector, keywords, seriousness factors, aggravating factors, mitigating factors, financial penalty, and other actions such as appeals. This document outlines the keywords for the Financial Services Enforcement Database and serves as a reference to help identify words and phrases to search for across the Database......

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CHECKLISTS

Checklist This Checklist sets out the principal direct and indirect tax considerations that a corporate borrower within the scope of UK corporation tax (a UK corporate borrower) ought to assess both prior to entering into a loan and over the life of that loan... It is designed to be used as a Checklist by the tax adviser to a UK corporate borrower, offering a concise outline of the relevant tax matters and providing space for the adviser to record notes... This Checklist proceeds on the basis that: the borrower is a company within the charge to UK corporation tax in relation to the loan, that is, either a UK tax resident company or a non‑ UK tax resident company for which the loan is attributable to its UK permanent establishment (a UK PE), or attributable to the non‑ UK resident company’s trade of dealing in or...

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CHECKLISTS

This Checklist explains the requirements and principal steps necessary to secure compliance, by a claimant or a defendant, with the second edition of the Pre- Action Protocol for Construction and Engineering Disputes (the Protocol). Parties involved in a dispute are expected to adhere to it before commencing proceedings in the Technology and Construction Court ( TCC). It prescribes what should occur prior to starting a claim in the TCC. Does the Protocol apply? The parties should first verify that the Protocol is applicable to their dispute—see Practice Note: Construction Pre- Action Protocol—application, exclusions and objectives. Under the Protocol, the claimant may, with unanimous written agreement of all intended parties to the proceedings, dispense with the pre-action process. What does the claimant need to do to comply? ......

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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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