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
As a general principle, an on-notice application must be served on every respondent as soon as reasonably practicable after filing, and in any case not fewer than three clear days before the date fixed for the court to hear it, unless a different period is then set by a rule, a practice direction, or a court order ( CPR 23.7(1)). For further guidance, see Practice Note: Filing and serving applications......
FORTHCOMING CHANGE: On starting employment, workers must receive specified information. A forthcoming entitlement will require that a worker is provided with a written notice of their right to join a trade union, issued at the same time as the section 1 statement of employment particulars. This will be introduced by proposed amendments to Part III of the Trade Union and Labour Relations ( Consolidation) Act 1992, as provided for in section 58 of the Employment Rights Act 2025 ( ERA 2025). The precise content of that notice, its format, and the way it must be issued will be set out in secondary legislation following consultation. Further particulars will outline the items to be included, the layout the notice should adopt, and the mandated method of delivery. To track the implementation of ERA 2025, see Practice Note: Employment Rights Act...
This checklist is aimed at an employer client This checklist sets out the steps an employer will ordinarily follow when looking to introduce changes to terms and conditions of employment that are not authorised by employees’ current contracts. It aligns with the Statutory Code of Practice on dismissal and re-engagement (the Code), which took effect on 18 July 2024. For further information on the Code, see Practice Note: Changing terms and conditions of employment— Statutory Code of Practice on ‘fire and re-hire’. Among other points, the Code makes clear that an employer should not float the possibility of dismissal too early, as this may hinder efforts to reach a consensual outcome. It also states that: a threat of dismissal must not be used as a bargaining device to place undue pressure on employees where the employer is not genuinely contemplating dismissal to achieve its aims the...
Constitutional and other documents Scrutinise the borrower’s constitution and ancillary papers to confirm clearly, at the outset, that: the borrower holds adequate authority under its constitutional instruments and governance documents (ie articles of association or partnership deed, etc) to incur debt and grant security interests, and no separate contract currently binding the borrower prevents or otherwise limits fresh/further borrowing or the creation of security interests (check any negative pledge wording in other finance, leasing or security papers) Lessons learned After verifying both the borrower’s powers and authority, locate and examine any current loan files and documentation for lessons learned, to determine what succeeds (avoid reinventing the wheel!), what fails (do not repeat known issues), and what might be refined or strengthened. Hindsight invariably makes everyone wiser. Consult the COO and CFO (as a minimum). Pose the following: who are the current bankers to the...
This checklist presents core tax queries to raise with a joint venture counterparty. The goal is to identify the principal UK tax considerations that could arise for the remaining joint venture participant(s) and/or any joint venture vehicle, with those potential matters highlighted in the list. It is assumed that the parties are UK tax resident corporate entities and that any joint venture vehicle will also be UK tax resident. The following Practice Notes give further detail on the UK tax issues signposted in this checklist and highlighted in this checklist as follows: The tax consequences of contractual joint ventures The tax consequences of establishing a joint venture partnership The tax consequences of operating and terminating a joint venture partnership The tax consequences of establishing a joint venture company The tax consequences of operating and terminating a joint venture company The tax consequences of...
General requirements for applications under section 17 of the Company Directors Disqualification Act 1986 This checklist outlines the information the court and the Secretary of State for Business and Trade ( So S) expect in an application by a director under section 17 of the Company Directors Disqualification Act 1986 ( CDDA 1986) seeking leave to act as a director notwithstanding disqualification. What extra particulars and evidence are needed will be fact specific. The application must be issued on Form N208. For guidance on the process, see Practice Note: Applications for leave to act as a director under section 17 of the Company Directors Disqualification Act 1986—jurisdiction, parties and the application procedure. It is crucial that the applicant (the disqualified director) supplies the fullest information possible, and does so at the earliest opportunity. Taking this approach maximises the prospect of persuading the So S and the...
This checklist outlines the key points to consider when appointing a notary for a loan transaction. It presumes the notary will be engaged in England or Wales, with local counsel arranging notaries in other jurisdictions where necessary. For further detail on the role and use of notaries in loan transactions, see Practice Note: Execution of documents in a loan transaction — Notarising documents in loan transactions; and for general guidance on notaries, see Practice Notes: Notaries and notarisation—notaries Notaries and notarisation—notarisation Notaries and notarisation—legalisation Preliminary questions when instructing a notary What tasks does the notary need to perform? Confirm with local counsel precisely what the notary must do to ensure the document is admissible in the relevant jurisdiction. Local counsel should email the final document(s) for notarisation, setting out all...
This Checklist This Checklist considers the details a company voluntary arrangement ( CVA) proposal must include under the Insolvency ( England and Wales) Rules 2016 ( IR 2016), SI 2016/1024 and Statement of Insolvency Practice ( SIP) 3.2, together with expectations from other stakeholders likely to be impacted by the CVA, notably the Pension Protection Fund ( PPF) and the British Property Federation ( BPF): the IR 2016, SI 2016/1024, rr 2.2, 2.3 Statement of Insolvency Practice ( SIP) 3.2 PPF requirements, see: Checklist for approval of CVAs involving the Pension Protection Fund BPF requirement, see: Checklist: British Property Federation engagement and red flags for company voluntary arrangements A CVA proposal sets out the detailed terms of a compromise between the company and its creditors, so it must be thorough and correct in every respect. If the proposal or...
This Checklist outlines the details that must be set out in correspondence to an unsuccessful provider to satisfy the transparency obligations required by the Health Care Services ( Provider Selection Regime) Regulations 2023, SI 2023/1348, reg 11(8)(b), Sch 9... Information to be included Contract or framework agreement title and reference The contract or framework award criteria The reasons why the successful provider was successful The reasons why the unsuccessful provider was unsuccessful The dates marking the start and end of the period for written representations (standstill) Further reading See Practice Note: — Health care procurement—procurement process— Basic selection criteria See Practice Note: — Health care procurement—procurement process— Key criteria See Practice Note: Health care procurement under the Provider Selection Regime— Transparency See Practice Note: Health care procurement under the Provider Selection Regime— PSR...
This Checklist This Checklist sets out the practical details to be gathered before making an application for a grant of letters of administration (with Will annexed). It applies to all instances of proving a Will where the applicant is not the executor. For guidance on when this route is appropriate, see Practice Notes: Letters of Administration with Will annexed Administration with Will annexed—priority to apply for grant— Q& As You must review the Will and ensure the statement of truth in the application form PA1P or the online application is accurately completed. The Will Confirm the original Will is available and that it was executed in the testator’s full name. If the name appearing in the Will differs from the testator’s official name, the explanation must be included in the application’s statement of truth (arising from the application form PA1P or the online...
Using CPR 18 ( Part 18) requests for further information When used appropriately, requests for further information under CPR 18—often referred to as Part 18 requests—are a potent procedural device. This checklist offers an organised route to decide whether to pursue a Part 18 request, how to draft it, and how to make an application under CPR 18.1. For fuller guidance on the points flagged below, see Practice Note: Making a Part 18 request for further information, and read this checklist alongside that guidance... Should I make a Part 18 request? Consideration Comment Is CPR 18 available in your proceedings? — CPR 18 is curtailed in some types of case, most notably small claims. Does the information you seek relate to a matter that is ‘in dispute in the proceedings’? — This is a key gateway for Part 18; it should not be...
Purpose If you need to acquire assets—particularly high-cost capital equipment—but lack the cash to pay outright, leasing or hire purchase ( HP) can provide an alternative to a loan. These options allow payment by instalments over time so future business revenues can fund those instalments. Cars and commercial vehicles Agricultural machinery Plant and machinery Computers Office equipment such as printers/copiers Hotel/restaurant equipment Review checklist—key risks Cost Under a lease or HP arrangement, the lessee/hirer pays a deposit and a series of instalments across an agreed period (usually 24 to 60 months or more). With HP only, there is an option—without any obligation—to buy the asset(s) at the end of the hire term. CHECK: the total payable under the lease or HP agreement does not exceed the interest otherwise payable on a loan for the same period......
This Checklist should be considered in conjunction with Practice Note: Instructing an expert Precedent: Letter of instruction to own expert (with drafting notes) Civil Justice Council Guidance for the instruction of experts in civil claims (from 1 December 2014) This Checklist assumes Proceedings have begun and permission to adduce expert evidence under CPR 35.4 is in place The expert is a witness (not an adviser), is not a single joint expert, and exchange is simultaneous Fees are not contingent and the party is not publicly funded Core confirmations Adherence to CPR 35, PD 35 and the Guidance; independence, impartiality and proportionality; no conflict Operate only within expertise and acknowledge limits; understand sanctions and liabilities Timetable is realistic; immediate notice of any revised opinion; collaborate on questions, meetings, joint statements and...
Checklist This Checklist summarises the issues an employer should evaluate when shaping a career break and/or sabbatical policy, and when setting the arrangements to support such leave. The expressions ‘career break’ and ‘sabbatical’ carry no fixed legal definition, and the title used for the break does not dictate its legal character. In practice: ‘ Career break’ commonly denotes a longer spell of unpaid absence during which the employment contract may remain in place, though more frequently it does not; and ‘ Sabbatical’ typically refers to a shorter period of leave, usually unpaid but potentially paid or partly paid, during which the contract does continue. For detailed information on career breaks and sabbaticals generally, see Practice Note Career breaks and sabbaticals......
Checklist This Checklist sets out the essential details required and the points to weigh up when preparing a secondment agreement. You can download and print it to serve as a practical framework or prompt for a client consultation, or as the starting draft of a secondment agreement. Use it on its own, or together with the following Precedents: Secondment agreement (employer—host) Letter—secondment letter (employer—employee) Secondment agreement (employer—host—employee) For fuller guidance on secondments, covering key considerations for dealing with a secondment and drafting the secondment agreement, consult Practice Note: Secondments......
This checklist reviews the employment law considerations that arise when carrying out a business reorganisation. It addresses initial planning points, whether a redundancy situation exists, ‘some other substantial reason’ ( SOSR), how the employer may resist claims about dismissals, whether collective consultation duties are engaged, changes to contractual terms and conditions, and if a TUPE transfer applies. It proceeds on the basis that there is a restructure but the undertaking continues to operate at the same site and, therefore, no ‘place of work’ redundancy arises. For broader guidance, see Business reorganisations—overview and Practice Note: Implementing a business reorganisation—employment issues. Initial considerations Assess the composition of the project team and safeguard project documentation to: preserve confidentiality and for consultation purposes (eg label all proposals as ‘subject to...
This Checklist summarises the immigration issues to be considered on a relevant transfer under the Transfer of Undertakings ( Protection of Employment) Regulations 2006 ( TUPE 2006), SI 2006/246, and sets out the steps required when participating in a transaction. It additionally highlights the relevant Practice Notes and the associated Precedent materials for reference. Immigration requirements during any transaction where TUPE 2006 does not apply fall outside the scope of this Checklist and are not addressed here. For a general outline of TUPE 2006’s effect and requirements, see: TUPE and asset purchases—overview. Initial considerations and due diligence In any scenario that may fall within TUPE 2006, robust, immigration‑specific due diligence is essential, particularly where a transferor employs sponsored migrants within its workforce. Immigration matters should be addressed at the earliest stage so the parties can plan for and comply with necessary...
This Checklist examines how easements come into being and whether they must, or may, be entered on the register at HM Land Registry. It addresses the following principal topics: Does an easement exist? Can it amount to a legal easement? Was the easement made by express grant? Is the express right set out in a deed of grant or a transfer? Is the right included within a lease? Has the easement arisen by implied grant? Has the easement arisen by presumed grant? Is the right merely equitable? Is the easement an overriding interest? Rights distinct from easements An application to HM Land Registry to register an easement may need supporting evidence of third party consents, or proof of compliance with a restriction on title. These matters are not explored in detail in this...
When and why is a foreign law legal opinion needed? A foreign law legal opinion is called for when lenders engage in cross-border lending, and they usually insist on opinions from counsel in every pertinent jurisdiction. Take, for instance, a deal in which the facility agreement and other finance documents are governed by the law of England and Wales, the borrower or another obligor is incorporated in the British Virgin Islands ( BVI), and some security assets are located in Jersey. In that case, the lender will expect legal opinions from lawyers in England and Wales, the BVI, and Jersey, in each of relevant jurisdictions involved in it......
This checklist surveys many of the typical issues that arise when requesting or supplying an employment reference, commonly encountered in practice. For more detailed guidance on references generally, see Practice Note: References. For a template letter of reference from an employer to a prospective new employer concerning a present or former employee, see Precedent: Letter—employee reference. Requesting references It is standard practice for an employer to provide a reference for an employee or ex-employee almost as a matter of routine, unless there are clear and legitimate reasons for not doing so in the circumstances, and a departure is unusual. Verify whether references are needed before employment starts—they usually will be—and therefore any offer letter should include wording that the offer is conditional upon, and subject to, receipt of references satisfactory to the employer. This statement must be given to the employee before they...
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 ]...