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
The details in this table are a brief overview and must be read alongside Practice Note: Structure and functions of EU institutions and bodies...
The EU Treaties affirm the allocation of competences between the EU and its Member States...
This Table The table provides practitioners with a convenient, practical overview of how a strict settlement contrasts with a trust for sale, helping ensure the appropriate grant application is properly made. It is intended to be read alongside Practice Note: Settled land grants for context as well......
STOP PRESS: From 24 February 2025, the principal provisions of the Procurement Act 2023 ( PA 2023) take effect. Procurements initiated on or after that date must proceed under PA 2023, while those started under the former regime—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 conducted and administered in accordance with that legislation. See Practice Note: Introduction to the Procurement Act 2023— PA 2023. PCR 2015 as assimilated law PCR 2015 are EU-derived domestic legislation and therefore constitute 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......
This Checklist reviews the entitlement to suspend under the Housing Grants, Construction and Regeneration Act 1996 ( HGCRA 1996), and the matters that ought to be carefully considered before any party opts to suspend carrying out its obligations and duties under a construction contract. Is there a general common law right to suspend a contract? No. At common law, a party to a contract has no general right to pause or withhold ongoing performance of contractual duties when the other party is in breach, unless the breach is sufficiently serious to constitute a ‘repudiatory breach’, thereby permitting the innocent party to rescind or bring the contract to an end (see Practice Notes: Termination of a construction contract— Common law termination and Repudiation of contract). How does the right to suspend arise in a construction contract?......
This Checklist highlights principal actions and considerations for a tenant weighing up surrendering its lease to its landlord. It is not comprehensive, and you should always assess whether further matters arise that require attention in your specific situation, including any fact-specific risks or obligations. This guidance proceeds on the basis that the following apply: the surrender is by express agreement and not effected by operation of law, and no immediate re-grant in favour of the tenant will follow the surrender You can read this Checklist alongside Practice Note: Lease surrenders and Checklist Surrender of lease—acting for the landlord—checklist. How to use this Checklist Although the mechanics of a lease surrender broadly resemble a sale and purchase in commercial terms (the tenant effectively sells and the landlord buys), notable distinctions remain. The opening section ( Key issues) identifies the main points for review, with...
This Checklist outlines the principal steps and matters a landlord should weigh up when considering accepting a tenant’s surrender of a lease. It is not comprehensive, and you should always assess whether any additional points arise in your specific circumstances. It proceeds on the basis that: the surrender is express and not effected by operation of law; and there will be no re-grant in favour of the tenant immediately following the surrender. This Checklist should be read alongside Practice Note: Lease surrenders and Checklist Surrender of lease—acting for the tenant—checklist. How to use this Checklist Whilst the mechanics of a lease surrender resemble a sale and purchase (the tenant is selling and the landlord is buying), there are differences. The opening section ( Key considerations) highlights the main issues to consider, with further explanation provided in the table in Procedure below when dealing with the...
ARCHIVED This Checklist is archived and is no longer maintained. Brexit From exit day (11 pm on 31 January 2020), the UK ceased to be an EU Member State. Under the Withdrawal Agreement, an implementation period applies during which EU law continues to govern the UK, which affects this Checklist. For further guidance, refer to Brexit Bulletin—key updates, research tips and resources—and the Brexit collection. On 3 February 2020, the UK and EU outlined their initial negotiating positions for the post‑ Brexit UK‑ EU relationship. Although the Political Declaration, appended to the Withdrawal Agreement, describes the framework for the future relationship, it is not legally binding, so either party may choose to move away from parts or all of it. If talks on a trade agreement between the UK and the EU do not succeed (a no trade deal Brexit), trade between the UK and the EU would...
This checklist helps you assess whether your firm has the systems needed to meet regulatory obligations for law firms, including SRA requirements, on supervision. It should be read alongside the subtopic: Supervision and file reviews... Management and control ☐ Confirm your governance arrangements are appropriate to operate or direct a business delivering regulated legal services. See subtopics: SRA authorisation and approval and Governance structures. Compulsory — SRA Authorisation of Firms Rules, r 2.2. ( Insert any comments you may wish to add regarding your firm’s arrangements) ☐ Ensure you have at least one manager or employee, or engage an individual, who is a lawyer of England and Wales with a minimum of three years’ practice, and who supervises the work undertaken by your firm. Compulsory — SRA Authorisation of Firms Rules, r 9.4. ( Insert any comments you may wish to add...
This Super SAR required notification checklist supports you in assembling a robust required notification. Read it in conjunction with the official Practice Note: Proceeds of Crime Act 2002—information sharing in the regulated sector—super SARs. Crucially, when correctly submitted, a required notification via the super SAR mechanism in the Proceeds of Crime Act 2002 ( POCA 2002) fulfils the statutory obligation to make any required disclosures under POCA 2002, ss 330–331, thereby removing the risk of criminal liability that would otherwise arise for not disclosing under those provisions. Where a National Crime Agency ( NCA) authorised officer makes the disclosure request, the individual tasked with providing the relevant information then must lodge the notification personally under that request. Where someone else within the regulated sector issued the disclosure request, the requester themselves must submit the notification, being the person who made the...
THIS CHECKLIST APPLIES TO DEFINED BENEFIT SCHEMES ONLY Schemes which require a summary funding statement Trustees of a defined benefit arrangement must draw up and distribute a summary funding statement to the scheme’s members and beneficiaries where the scheme: is an occupational pension scheme that meets the requirements in Schedule 1, paragraph 1 of the Occupational and Personal Pension Schemes ( Disclosure of Information) Regulations 2013, SI 2013/2734 (the Disclosure Regs 2013). For further details, see Disclosure requirements applicable to occupational and personal pension schemes after 5 April 2014— Scope of the 2013 Disclosure Regulations; and falls within the scope of Part 3 of the Pensions Act 2004......
Step/action Time (days) Section/rule Where a bankrupt’s automatic discharge from bankruptcy has been suspended by an order under section 279(3) of the Insolvency Act 1986 ( IA 1986), the bankrupt may apply to remove that suspension. This summary provides a checklist and timeline for applications seeking to lift a bankrupt’s suspension from discharge, setting out the stages from preparing the application for issue, through to the making of the order lifting the suspension, and the matters to address once the order is made... For further guidance on a bankrupt’s discharge, and any suspension of that discharge, see: Practice Note: Discharge from bankruptcy Practice Note: Applying to lift an order suspending discharge from bankruptcy Summary checklist and timeline for a suspension of automatic discharge from bankruptcy application 1....
Checklist and timeline This concise checklist and timetable is prepared from the viewpoint of a claim started under sections 339 and/or 340 of the Insolvency Act 1986 ( IA 1986) by a trustee in bankruptcy (trustee). Step/action Time (days) Section/rule Examine the background and circumstances culminating in the debtor’s bankruptcy and the issues underpinning the claim(s) against the respondent(s) (usually those who received the payments/transactions). This encompasses securing the books, papers or records concerning the bankrupt’s estate or affairs that must be handed to the trustee, and conducting interviews with, among others, the bankrupt, the bankrupt’s spouse, former spouse, civil partner or former civil partner, and any person who appears able to provide information about the bankrupt or their dealings, affairs or property, as relevant to the matters in issue. No limit (subject to...
Checklist and timeline This concise checklist and timeline is prepared on the footing that proceedings are brought under sections 238 and/or 239 of the Insolvency Act 1986 ( IA 1986) by an administrator or liquidator, and not by any assignee of the claim. Step/action: Review the events leading to the company’s insolvency and the factors underpinning the claim(s) against the respondent(s) (typically the recipients of the relevant payments/transactions). This involves securing the company’s books and records, accounting data/statements and bank statements, and interviewing directors, former directors, and any person with knowledge of the promotion, formation, business dealings, affairs or property of the company. Note that if the office-holder signals a claim against the respondent(s), they risk losing investigative powers under IA 1986, ss 235–236 in relation to that claim. Time (days): No limit (subject to limitation). ...
Under section 279(1) of the Insolvency Act 1986 ( IA 1986) A bankrupt is released from bankruptcy automatically at the expiry of one year starting on the date the bankruptcy order is made, pursuant to section 279(1) of the Insolvency Act 1986 ( IA 1986). In some circumstances, however, it is preferable to apply to the court for an order suspending that automatic discharge. This concise checklist and timetable addresses applications to suspend automatic discharge from bankruptcy, outlining each stage from preparing the application for issue through to the making of the suspension from discharge order, together with matters to be dealt with after the order is made. The checklist and timetable do not apply to criminal bankruptcies under IA 1986, ss 264 and 280, nor to applications by the official receiver ( OR) under the Insolvency ( England and Wales) Rules 2016 ( IR...
Annulment: payment in full Under section 282 of the Insolvency Act 1986 ( IA 1986), a bankrupt may apply to have their bankruptcy annulled where they can discharge in full, and in particular in their entirety, the bankruptcy estate’s costs, expenses and claims, or, alternatively, provide security for those sums, as applicable. This Checklist and timeline sets out the procedure for annulment applications on this basis, identifying each step sequentially after settlement of the estate’s costs, expenses and claims, from payment through to the making of the annulment order, together with the matters that must be addressed once the order has been made, thereafter. It shows the stages in order. This Checklist and timeline does not apply to, or address, applications brought on the alternative ground in IA 1986, s 282(1)(a), namely a contention that the bankruptcy order should not have been made. For a...
Annulment: bankruptcy order ought not to have been made One of the grounds in section 282 of the Insolvency Act 1986 ( IA 1986) on which a bankrupt may seek annulment is that the bankruptcy order should not have been made. This Checklist and timeline summarises the procedure for applications brought on that basis, setting out the journey from preparing the application for issue right through to the making of the annulment order, together with matters to be addressed once the order is made. Drafting the application for issue Making of the annulment order Post-order matters to be dealt with This Checklist and timeline does not apply to applications relying on the alternative ground under IA 1986, s 282—where the costs, expenses and claims of the bankruptcy estate are paid in full or secured. For a Checklist and timeline dealing with that...
The suitability obligation All authorised firms are subject to a suitability obligation, which requires them to take reasonable steps to ensure that any personal recommendations, or decisions to trade, are suitable for their clients. The suitability obligation applies to: firms providing investment advisory services, and firms providing discretionary portfolio management services Firms providing non‑advised investment services will instead be subject to the appropriateness obligation (see Practice Note: Appropriateness). Firms must gather the information ‘necessary’ about their clients in respect of their: knowledge and experience in the investment field relevant to the type of investment or service, financial situation, and investment objectives For more information on the suitability obligation, see Practice Note Suitability. When does the obligation to provide a suitability report apply? In certain circumstances, firms are required to provide suitability reports to their clients under COBS 9.4......
For law firms For law firms, whether you are considering a merger, taking over another practice, disposing of the business or winding it up, the successor practice provisions are almost invariably engaged in such scenarios. You must give careful thought to these rules and their effect on the deal, at every stage, as outcomes are frequently truly surprising, costly and, in the end, can pose intolerable risks for either party or, indeed, both. Grasping the ramifications of your proposals is essential. When the parties collaborate, it is often feasible to reduce exposures enough and in good time to allow a deal to move forward that might otherwise collapse. As ever, knowledge is power. Seldom will buying any element of a legal practice not result in the purchaser becoming a successor practice—you are generally safest to presume that is so. Section 1 aims to outline...
Parties Who are the parties involved? In particular, specify: the investor(s) the founders the investee company Conditions Are there any pre-conditions to finalising the investment? What must each party do to meet those conditions, and by what deadline? Share subscription What is the investee’s capital structure? Which class and how many shares will each shareholder (the investor, the founders and any other shareholders) take up? Warranties Who will give the warranties—only the founders, or both the company and the founders? Will they be provided jointly, jointly and severally, or severally? How wide-ranging should the warranties be, and are there priority areas to cover? What limits will govern warranty claims, including: the period within which claims can be brought caps on each warrantor’s liability and on aggregate liability de minimis for individual claims and an aggregate...
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 ]...