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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
This Checklist outlines the requirements for selecting or appointing negotiating representatives for the purposes of the Information and Consultation of Employees Regulations 2004 ( ICER 2004), SI 2004/3426. For broader guidance on representatives under ICER 2004 generally, see Practice Note: ICER employee representatives. For further guidance on ICER 2004, refer to Practice Note: The Information and Consultation of Employees Regulations 2004. Government guidance issued in 2006 has been archived but remains a useful source, particularly as the regulations themselves offer limited detail on the matters addressed in this Checklist. See also the Acas guidance on informing and consulting on workplace matters. General requirements Following a valid employee request, the employer must, as soon as reasonably practicable, put in place arrangements enabling employees to appoint or elect negotiating representatives to negotiate the information and consultation arrangements to be...
This checklist outlines the requirements for choosing or appointing information and consultation ( I& C) representatives for the purposes of the Information and Consultation of Employees Regulations 2004 ( ICER 2004), SI 2004/3426. For broader guidance concerning representatives under ICER 2004, refer to Practice Note: ICER employee representatives. For further guidance on ICER 2004, see Practice Note: The Information and Consultation of Employees Regulations 2004. Government guidance issued in 2006 has been archived but remains a useful source of guidance. See also the Acas guidance on informing and consulting on workplace matters. General requirements I& C representatives do not need to be the same individuals as negotiating representatives; employees may appoint different people to serve as I& C representatives. I& C representatives must be genuinely representative of their constituencies. The arrangements should be transparent and acceptable to employees, with outcomes viewed as...
This Checklist offers a concise overview of the main statutory and practical issues in drafting and negotiating planning obligations under section 106 of the Town and Country Planning Act 1990 ( TCPA 1990), more commonly known as section 106 agreements. For more detailed guidance on: the principal statutory requirements for planning obligations—covering formalities, relevant parties, registration formalities, when obligations become effective, and dispute resolution processes—see Practice Note: Planning obligations—key points how to prepare a section 106 agreement in line with statutory criteria while achieving practical efficiency—see Practice Note: Drafting section 106 agreements—practical advice for developers how to renegotiate a section 106 agreement—see Practice Note: Renegotiating planning obligations/section 106 agreements Have the statutory requirements been fulfilled? If the requirements of TCPA 1990, s 106 are not met, the obligations set out in the agreement may not constitute a 'planning...
This Checklist It offers a succinct, top-level outline of points a manager ought to weigh up when running a disciplinary hearing. It serves as general guidance only; managers should also follow the employer’s code of conduct and its disciplinary and dismissal procedure. For fuller guidance on preparing for, and carrying out, a disciplinary hearing, refer to Practice Notes: How to plan and prepare for a disciplinary hearing and How to conduct a disciplinary hearing. See as well Dismissal—misconduct checklist for employer [ Archived]......
FCA involvement in compromises of regulated firms When a scheme of arrangement, restructuring plan, company voluntary arrangement or individual arrangement is put forward in relation to a regulated firm (defined below), the Financial Conduct Authority ( FCA) should be engaged at the outset. The FCA acts as the conduct regulator for UK financial services firms and markets. It is obliged under section 1B of the Financial Services and Markets Act 2000 ( FSMA 2000) to advance specified objectives, including the consumer protection objective. The FCA states that its statutory aims are to secure an appropriate level of consumer protection and to safeguard and strengthen the integrity of UK financial markets, with the intention of limiting the number of proposed compromises (via a scheme of arrangement, restructuring plan, company voluntary arrangement or individual arrangement) it considers unsuitable (see FG22/4, para 1.2). On 5 July 2022, the FCA...
Where a scheme of arrangement, restructuring plan, company voluntary arrangement or individual arrangement is put forward in respect of a regulated firm (defined below), the Financial Conduct Authority ( FCA) should be engaged at the earliest possible stage. The FCA serves as the conduct regulator for both financial services firms and for the financial markets across the United Kingdom. Under section 1B of the Financial Services and Markets Act 2000 ( FSMA 2000), it is tasked with pursuing specified objectives, including one centred on consumer protection in practice. The FCA states its statutory aims as securing an appropriate level of protection for consumers and safeguarding and strengthening the overall integrity of UK financial markets, with the intention of limiting the volume of proposed compromises it deems unsuitable (see FG22/4 para 1.2). On 5 July 2022, the FCA issued guidance on...
This Checklist This Checklist outlines the characteristics and considerations that may suggest whether an individual does, or does not, have the status of an employee or a worker, for example within the meaning of section 230 of the Employment Rights Act 1996 ( ERA 1996), or may instead be self-employed for employment law purposes. A number of core employment rights are conferred only on employees. Many other protections are extended to the broader category of ‘workers’, which includes, but is not limited to, employees (ie every employee is also a worker, but not the other way round). For further detail, see Practice Notes: Employee status and Worker status. For a checklist of the rights available to those with employee or worker status, see: Employees and workers: checklist of rights. From a tax standpoint, a person is either employed or...
This Checklist sets out essential steps for arbitrators to consider when deploying artificial intelligence (‘ AI’) tools, or where AI is involved in arbitral proceedings. Given the fast‑moving nature of the technology and the applicable laws and regulations, please be aware that this is not a comprehensive list and should be treated as such. The Checklist is intended to provide guidance on best practice. Understanding AI Key points Notes Definition of AI Artificial intelligence refers to computer systems’ capacity to exhibit human‑like cognitive functions, such as decision‑making, planning, reasoning and knowledge representation. IBM characterises AI as technology that allows computers and machines to emulate human learning, understanding, problem‑solving, decision‑making, creativity and autonomy. WIPO portrays AI as a branch of computer science focused on building machines and systems capable of performing tasks thought to require human intelligence. Machine learning and deep learning are two...
The Checklist seeks to outline the principal actions that arbitrators should consider across the entire course of a proceeding, beginning with appointment and the first procedural order and ending with delivery of the award and completion of their obligations. It offers direction on the types of provisions that may feature in procedural orders addressing data security throughout the duration and lifespan of an arbitration. Please be mindful, in light of the evolving cybersecurity ecosystem and applicable laws and regulations, that this is not an exhaustive catalogue. Rather, the checklist functions as guidance on best practice and clarifies the considerations that may arise at each milestone. Arbitration phase: pre-appointment of the Tribunal Legal Steps Safeguard your digital identity so you are seen as independent and impartial, notwithstanding the difficulties posed by an online presence. Refer to: Checklist for Arbitrators on the Use of Social Media and the Duty of...
HMRC guidance on compromises using Part 26 schemes and Part 26A restructuring plans In corporate insolvencies, HMRC commonly ranks as a secondary preferential and/or unsecured creditor (see Practice Note: Waterfall of payments—a comparative guide), a status that often serves as the relevant comparator or alternative to a Part 26 scheme or a Part 26A restructuring plan. On 1 November 2023, HMRC issued guidance covering compromises under Part 26 schemes (see: Schemes of arrangement—overview) and Part 26A restructuring plans (see: Restructuring plan—overview) (see: HMRC publishes guidance on using debt management schemes to restructure finances— LNB News 15/11/2023 13). Practitioners should take account of this guidance whenever a proposed scheme/plan includes HMRC as a creditor. HMRC will only back a restructuring where it considers there is a realistic prospect of success. If HMRC does not consider success realistic, it will engage with the scheme/plan proponent to explore other means of...
This Checklist This Checklist provides points to weigh up when preparing and seeking sign-off for a company voluntary arrangement ( CVA) involving the Pension Protection Fund ( PPF). It draws on PPF Guidance Note 5 issued in 2018 (see PPF Guidance Note 5: CVAs). When an employing company (or all participating employers in a last man standing scheme) files a CVA proposal with the court, a PPF assessment period begins. Under section 137 of the Pensions Act 2004, the PPF assumes the pension trustees’ voting entitlement (see Practice Note: The Pension Protection Fund—eligibility and entry). In practice, the PPF will typically cast a vote for or against the proposal rather than refrain. The PPF is consistently focused on avoiding any precedent that might allow pension schemes to be diluted where potential PPF entry could arise in the near future (the PPF observes that this has...
This Checklist Produced together with both Josephine Howe, partner, and Grace Gao, counsel, at Ogier, this checklist was created...
Income payments order The trustee in bankruptcy (trustee) may seek an income payments order ( IPO) pursuant to section 310 of the Insolvency Act 1986 ( IA 1986) where, having assessed matters, they consider the bankrupt enjoys surplus income once the bankrupt’s reasonable domestic needs are allowed for. See Practice Note: Income payments orders ( IPOs) under section 310 of the Insolvency Act 1986. The court is responsible for setting the venue for the hearing of the trustee’s application. The trustee must provide the bankrupt with not less than 28 days’ notice of any application, enclosing the application itself and a statement of the grounds on which the order is requested. Up to five business days before the hearing date, the bankrupt may consent to the order by notifying both the court and the trustee. Alternatively, by attending the hearing, the bankrupt may make any...
This checklist sets out the key matters to weigh up when preparing post-termination restrictions for a client, whether the aim is to safeguard trade secrets and confidential material, a trade connection, or the stability of the workforce. For guidance on leading rulings and key decisions concerning the enforceability of post-termination restrictions, see Practice Note: Decisions on post-termination restrictions and garden leave in employment contracts. General the individual instructing you on the restrictions should be sufficiently senior and engaged in day-to-day operations to brief you on the business and the employee’s function in it, the legitimate interests to be protected, and the proportionality and reasonableness of the restraints and restrictions, to ensure instructions can be provided for these points pinpoint the employer’s legitimate business interests, namely trade secrets and confidential information, trade connection, and the stability of the...
Checklist This Checklist summarises the potential claims against a defendant where the claimant in a personal injury case has died before trial. It reviews the principal statutory regimes—the Law Reform ( Miscellaneous Provisions) Act 1934 ( LR( MP) A 1934) and the Fatal Accidents Act 1976 ( FAA 1976)—and indicates who may bring the claim and the recoverable heads of loss. For further guidance, see Practice Notes: Law Reform Act or Fatal Accidents Act? and Claims involving a fatality—heads of damage... Cause of action Claim on behalf of the deceased’s estate (under LR( MP) A 1934) Who can bring the claim? By the administrator or executor of the estate. A valid will or Grant of Letters of Administration will be required... Heads of loss Guidance on the recoverable heads of loss is provided by LR( MP) A 1934 and FAA 1976 and in the referenced Practice Notes......
When establishing a charity, there are numerous matters to settle that will apply not only to its formation but also to its future running and development. Accordingly, the practitioner must guide the client through a series of steps and questions to obtain a complete and accurate picture. Charity objects Have the charity’s promoters clearly defined its object(s)? Do the objects qualify as ‘exclusively charitable according to the law of England and Wales’? Name If registration is anticipated, have the promoters ensured the proposed name is acceptable to the Charity Commission? Benefit locus Will the benefits be limited to individuals linked to a specific locality or area? Finance Will funding derive from: a gift or endowment from an individual benefactor or a group of benefactors? ad hoc or regular donations or subscriptions from members of the general public? grant(s) from public or charitable sources? ......
Checklist This Checklist outlines the core components that expert witnesses should include within their reports so they comply with CPR PD 35, para 3.2 and the Civil Justice Council’s Guidance for the instruction of experts in civil claims 2014 (the Guidance). For more information on the content of an expert’s report, see Practice Note: Expert reports. Details of the expert's qualifications The qualifications must be relevant to the matters in the claim on which the expert has been asked to provide their opinion. The principal information required is the expert’s academic and professional credentials. Where highly specialised knowledge is necessary, include particulars of specific training, investigatory work and any other pertinent experience which, in their view, equips them to give such evidence. Details of any literature or other material relied on in making the report Where opinions are cited without verification, the full particulars of those opinions must be set out. If...
ARCHIVED: This Practice Note is archived and no longer updated. It is supplied for background reference only. The Checklist aims to equip arbitration practitioners with a catalogue of strategic, procedural and practical considerations that could be pertinent to—and should be weighed before, during and/or after—arbitral proceedings in the context of the coronavirus ( COVID-19) pandemic and the responses of national governments and international arbitral organisations, including arbitral institutions. The Checklist is not comprehensive in scope and not every point will be applicable in each arbitration. It likewise omits any assessment of the substantive disputes that may lead to proceedings in the first instance (for example, claims over failed contractual performance said to result from the pandemic and its consequences). Although prepared with commercial arbitrations in view, many elements will equally apply to other arbitral forms, including...
Checklist This checklist is designed for employment lawyers and outlines the measures an employer will usually follow when wishing to implement amendments to terms and conditions of employment that are not authorised under employees’ current contracts. For broader guidance on the legal and practical considerations around making changes to employment contracts, see Practice Note: Changing terms and conditions of employment. This checklist aligns with the Statutory Code of Practice on dismissal and re-engagement ( Code), which took effect on 18 July 2024. For further detail on the Code, see Practice Note: Changing terms and conditions of employment— Statutory Code of Practice on ‘fire and re-hire’. Although flagging the possibility of dismissal and re-engagement at the outset may compress the process, the Code emphasises that an employer should not introduce the prospect of dismissal unduly early, as this can undermine attempts to secure an agreed...
BPF CVA red flag clauses - insolvency engagement guidance ( Jan 2020) The British Property Federation ( BPF) is the trade body for the UK real estate sector and strongly urges potential promoters of a company voluntary arrangement ( CVA), together with their nominees, to engage with the BPF before any CVA proposal is circulated. This dialogue enables representatives of the landlord community to pinpoint matters within a CVA that may require action, thereby helping to maximise the overall prospects of approval. Such engagement should (the BPF stresses) be in addition to—and not a replacement for—discussions with individual landlords (or groups of landlords) about issues specific to them. The Jan 2020 guidance contains a statement of best practice setting out how companies are expected to work with the BPF on prospective CVAs. A core element of that guidance is a list of what the BPF...
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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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