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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
Most recent Checklists
Checklist This Checklist outlines essential compliance steps for law firms undertaking outsourcing, beginning when your firm initially contemplates entering an outsourcing agreement and continuing through to, and encompassing, all the post-agreement audit activities......
Financial services and data protection regulatory regimes Financial services firms must ensure their outsourcing arrangements align with the outsourcing obligations of two distinct regulatory frameworks: the financial services regulatory regime, mainly comprising: Commission Assimilated Retained Regulation ( EU) 2017/565 (the UK Mi FID II Organisational Regulation) the Senior Management Arrangements, Systems and Controls sourcebook ( SYSC) in the Financial Conduct Authority ( FCA) Handbook the Outsourcing Part of the Prudential Regulation Authority ( PRA) Rulebook the data protection regulatory regime, centred on the onshored General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR) The Checklist delivers high-level guidance on the outsourcing expectations under both regimes and acts as an initial step towards creating a unified...
ARCHIVED : This archived table sets out details of the renumbered provisions in the Taxation of Chargeable Gains Act 1992 (‘the Act’), arising from the redrafting of Part 1 of the Act by the Finance Act 2019. From 6 April 2019, Part 1 of the Taxation of Chargeable Gains Act 1992 ( TCGA 1992) was recast. The revised TCGA 1992, Pt 1 was brought in by section 13 and Schedule 1 of the Finance Act 2019, with the principal objective of bringing disposals of UK non-residential property by non- UK residents within scope of UK tax, so that disposals of both residential and non-residential UK property on or after 6 April 2019, subject to specified exemptions, fall within capital gains tax ( CGT) or corporation tax on chargeable gains. The consequence is that UK residents and non-residents are equally within charge on...
These tables have been archived and is not maintained. The tables set out the following: the specific locations in TIOPA 2010, Part 9A for the former corporation tax assumptions; and the new assumptions within TIOPA 2010, Part 9A that do not derive entirely from the old rules The new assumptions are further explained in: CFC rules—the corporation tax assumptions......
This Checklist sets out three principal tables: Matters designated as ordinary resolutions under the CA 2006 Resolutions that are commonly approved as ordinary resolutions Ordinary resolutions that must be filed with Companies House Ordinary resolutions The Companies Act 2006 ( CA 2006) identifies specific matters that must be decided by ordinary resolution (that is, a simple majority) of a company’s members, for example the removal of a director. CA 2006 also sets out matters that must be achieved by special resolution of the company, or where a 75% threshold applies. Where CA 2006 requires that something is to be done by passing a resolution but does not state the category of resolution, an ordinary resolution will be sufficient, unless the articles of association require a greater majority or unanimity......
For further information relating to each of these stages, see the following Practice Notes: Case oversight in the magistrates’ courts The course of a criminal matter Phases of a summary hearing Burden and level of proof in criminal cases Ability and compellability of witnesses in criminal cases Witness testimony during a criminal trial Special arrangements Expert testimony in criminal proceedings Admitting a defendant’s bad character in criminal proceedings Admissibility of hearsay evidence in criminal proceedings Penalties imposed after conviction Obligation to give reasons and set out the effect of sentence imposed......
Options for landlord This checklist outlines the choices open to a landlord of commercial premises where the tenant is an insolvent individual, and explains the effect of restrictions operating under the various insolvency regimes. Where a landlord of a commercial property seeks to take steps against an insolvent tenant who is an individual, this checklist should then be referred to to confirm whether the landlord is permitted to pursue such action......
Options for landlord This checklist outlines the choices open to a landlord facing an insolvent corporate tenant, and explains how restrictions arising under the various insolvency regimes may affect those choices. If a landlord intends to pursue action against an insolvent corporate tenant, consult this checklist to verify whether the landlord is allowed to proceed where permitted......
Call or put option? In a call option, the purchaser holds the reins, as it may demand transfer of the asset. The seller should recognise that its intentions for the site could be curtailed by that right, and plans for the property restricted. A put option, by contrast, places control with the seller, enabling it to require the purchaser to take the property and complete the acquisition, obliging the buyer to buy. Option period For a call option, the vendor should be mindful that the land could be effectively frozen throughout the option window, potentially sterilising its use. Accordingly, the deal ought to state a clear long‑stop date to cap the period. The Perpetuities and Accumulations Act 2009 ( PAA 2009) removed the rule against perpetuities for options, so those granted on or after 6 April 2010 do not need a specified long‑stop date in this...
Call or put option? Under a ‘call’ option, the purchaser holds the reins, as it can demand a transfer of the property. By contrast, a ‘put’ option leaves the seller in charge, enabling it to compel the purchaser to complete a transfer. Accordingly, the purchaser must take particular care that the transfer provisions—especially on valuation and, where relevant, insurance—are as advantageous as possible. Seller's charges If the property is charged when the option is granted, the mortgagee might defeat the option by using its power of sale. To guard against this, ensure the mortgagee either: becomes a party to the agreement (uncommon in practice), or gives written consent to the grant of the option In both scenarios, the mortgagee should confirm that, if the purchaser exercises the option, it will take the property free of the charge; or, if the mortgagee sells under its power, it...
This Checklist is intended to help practitioners adopt a structured method for resisting a without‑notice application for an interim injunction. It should be read in conjunction with the detailed guidance contained in the following Practice Notes: Interim injunctions—without notice applications Interim injunctions—the American Cyanamid guidelines Interim injunctions—drafting the order Although this Checklist concentrates on without‑notice applications, there is inevitably some cross‑over with matters that arise on on‑notice applications. Practitioners should therefore also familiarise themselves with the detailed guidance contained in: Opposing an on notice interim injunction application—checklist as well. 6 April 2025 changes With effect from 6 April 2025, the CPR provisions governing interim injunctive relief were amended. In particular, CPR 25 underwent extensive revision, and the related Practice Directions were revoked. This revocation covered the example draft orders found in Annex A and Annex B to Practice Direction 25A. In addition, three new ‘model...
Interim injunction applications are rarely simple. Applicants face numerous procedural and substantive obstacles before a court will even contemplate awarding this discretionary remedy. This Checklist addresses those issues and aims to help practitioners adopt a structured method when replying to—and, where appropriate, opposing—an on‑notice interim injunction application. It should be read alongside the detailed guidance in the following Practice Notes: Interim injunctions—on notice applications Interim injunctions—the American Cyanamid guidelines Interim injunctions—drafting the order For further assistance with without notice applications, see: Opposing a without notice interim injunction application—checklist. 6 April 2025 changes With effect from 6 April 2025, the CPR provisions governing interim injunctive relief were amended. Notably, CPR 25 underwent substantial revision and the related Practice Directions were revoked, including the exemplar draft orders formerly found in Annex A and Annex B to Practice Direction 25A. In addition, three new ‘model orders’ took...
This Checklist sets out the issues that should be considered for inclusion in a franchising operations manual The franchise operations manual captures the real-world execution of the franchisor’s system, describing the tasks the franchisee must carry out and the support it can anticipate from the franchisor. Under the franchise agreement, the franchisee is bound to follow the manual to the letter, a discipline widely recognised as driving commercial success. The franchisee will typically consult it daily, particularly during the early phase of trading. The manual might be prepared by the franchisor, or by an independent consultant working with the franchisor’s input. If an outside consultant is engaged, the franchisor must be satisfied that the consultant understands the franchise business. Without that familiarity, the manual may fail to address risks and other essential points that require attention, which could leave the franchisor...
This timeline has been archived. It summarises the principal milestones for UK, EU and international operational resilience expectations for financial services firms. In the UK, the Authority ( FCA), working with the Bank of England ( Bo E) and the Prudential Regulation Authority ( PRA), finalised the operational resilience regime in March 2021, with rules taking effect from 31 March 2022. At EU level, Regulation ( EU) 2022/2554 on digital operational resilience for the financial sector (the Digital Operational Resilience Act, DORA) and Directive ( EU) 2022/2556 modifying selected Directives on digital operational resilience (the Amending Directive) were published in the Official Journal of the EU on 27 December 2022. For developments from January 2024 onwards, refer to: EU operational resilience—timeline for matters concerning EU operational resilience, or UK Benchmarks Regulation—timeline for items relating to UK operational resilience. For further detail on the UK...
Free and open source software ( OSS) Free and open source software ( OSS) is a collective term for software released under a licence that gives the recipient rights to use, alter, and share it—whether in its original form or a derivative—usually without charge or royalty, and for which the software’s source code is accessible. This stands in contrast to the software licences lawyers are more accustomed to, which may seek to stop the licensee from accessing the source code, using the software across multiple users, locations or computers, and from making and distributing copies. Free and open source software (often called ‘ FOSS’) emphasises freedom rather than restriction. Although it is typically provided free of charge (gratis), the ‘free’ in ‘free software’ is intended to indicate liberty, not price. Another acronym, ‘ FLOSS’, is occasionally used, where the ‘ L’ stands for...
This checklist outlines key considerations when preparing and finalising an on-demand bond for a construction project. For additional guidance on bonds within the construction sector, refer to Practice Notes: Performance bonds—construction projects and On demand performance bonds—construction projects for further detail. Parties Where a party’s registered office lies outside England and Wales, it may have to nominate an address for service within England and Wales and comply accordingly. Be especially cautious before agreeing to a surety located outside the UK and, where relevant, confirm the surety is properly authorised to issue bonds in the UK. Always include company registration numbers so companies can be identified later......
ARCHIVED: This Checklist has been archived and is no longer maintained. It outlines historic provisions that were revoked on 1 April 2013 and continues to be unmaintained. Nevertheless, owing to transitional arrangements, those provisions may still hold relevance in proceedings where a conditional fee agreement or an insurance policy was entered into before 1 April 2013. These are the same provisions referenced within CPR PD 48, para 1.3 accordingly herein......
Legal due diligence ( LDD) checklist Set out below is a legal due diligence ( LDD) checklist highlighting key matters to assess when undertaking an oil and gas transaction. This schedule serves as guidance only and therefore should not be treated as a complete list. Each LDD review ought to be carefully customised to the specific target and the relevant acquisition contract (including, in particular, consideration of the breadth of any warranties and indemnities granted therein, which will influence both the nature and the breadth of the LDD that is required). For additional practical guidance on the financing of energy, power and resources projects across various sectors, including those addressed in this checklist, see also the textbook entitled Energy and Resources Financing: A Practical Handbook......
The Investigatory Powers Act 2016 ( IPA 2016) revamped the legal regime regulating covert surveillance by public authorities. IPA 2016 superseded large parts of the framework previously, though not solely, contained in the Regulation of Investigatory Powers Act 2000 ( RIPA 2000). See Practice Note: The regulation of intelligence gathering—an introductory guide. This note outlines the offences introduced by IPA 2016. For details of general sentencing limits in a magistrates’ court, see Practice Note: Sentences imposed following conviction— General limits on magistrates’ courts powers to impose custodial sentences following conviction... Section Offence Statutory defence Maximum sentence IPA 2016, s 3 — Unlawful interception: a person, by conduct in the UK, deliberately intercepts a communication during its transmission without lawful authority. Defence: where the individual has the right to control the operation or use of the system, or had that...
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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 ]...
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