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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 sets out core topics for firms entering consumer credit, addressing essential management and compliance matters within the Financial Conduct Authority ( FCA) framework. It organises themes such as authorisation, threshold conditions, the Senior Managers and Certification Regime ( SM& CR), systems and controls, business planning, FCA Principles, the Consumer Duty and continuing regulatory duties, including adherence to the Consumer Credit sourcebook ( CONC) and the Consumer Credit Act 1974 ( CCA 1974). For fuller guidance, including how the application process works, see Practice Note: FCA authorisation of consumer credit firms. Scope and regulatory status Do the firm’s activities amount to regulated consumer credit activities under section 19 of the Financial Services and Markets Act 2000 ( FSMA 2000), and the Financial Services and Markets Act 2000 ( Regulated Activities) Order 2001, SI 2001/544 ( RAO)? See Practice Notes: The general...
Checklist for overseas partners on preventing bribery Policies and procedures Does the company have a clear, robust and practical code of ethics that expressly states zero tolerance for bribery and corruption? Is that code backed by proportionate policies? Is there visible top-level commitment from the Board, and does a suitably experienced senior officer oversee the anti-bribery framework? Are anti-bribery policies and procedures a standing agenda item at Board meetings? Are the Board’s discussions on these policies and procedures comprehensively recorded in the minutes? Is there a Board sub-committee charged with updating and enforcing the anti-bribery policies and procedures? Do the company’s General Counsel and, where applicable, the legal/compliance team have specific expertise in anti-bribery legislation and practice? If not, (a) are external lawyers with the requisite knowledge retained; and (b) is an appropriate internal training programme considered? Do Board members receive the same anti-bribery training as other...
STOP PRESS: The Financial Remedies Guide 2026 Issued on 13 March 2026 by Mr Justice Peel ( National Lead Judge of the Financial Remedies Court) and His Honour Judge Hess ( Deputy National Lead Judge of the Financial Remedies Court), with the President of the Family Division’s approval, the Financial Remedies Guide 2026 now replaces and supersedes the following guidance and notices: the Statement on the efficient conduct of financial remedy cases allocated to a High Court judge whether sitting at the Royal Courts of Justice or elsewhere (1 February 2016) (the High Court judge level efficiency statement) the Statement on the efficient conduct of financial remedy hearings proceeding in the Financial Remedies Court below High Court judge level (11 January 2022) (the below High Court judge level efficiency statement) the Financial Remedies Court Primary Principles document (11 January 2022) the...
STOP PRESS: The Financial Remedies Guide 2026, issued on 13 March 2026 by Mr Justice Peel ( National Lead Judge of the Financial Remedies Court) and His Honour Judge Hess ( Deputy National Lead Judge of the Financial Remedies Court), with the approval of the President of the Family Division, now replaces and supersedes: the Statement on the efficient conduct of financial remedy cases allocated to a High Court judge whether sitting at the Royal Courts of Justice or elsewhere (1 February 2016) (the High Court judge level efficiency statement) the Statement on the efficient conduct of financial remedy hearings proceeding in the Financial Remedies Court below High Court judge level (11 January 2022) (the below High Court judge level efficiency statement) the Financial Remedies Court Primary Principles document (11 January 2022) the Notice from the Financial Remedies Court: electronic bundles (19 April 2022) the Allocation of...
This Checklist offers direction to contract drafters and their clients on the first matters to consider when entering into contracts in general. Companies conclude agreements daily, touching many areas of their operations. It is vital that commercial organisations understand and manage both negotiation and performance of the contracts they enter. This Checklist is designed to support drafters and clients with those initial considerations for contracts generally. It does not cover the particular issues of specific contracts, and focuses instead on entering agreements in general. Consideration Description Set objectives Consider: what you aim to achieve whether that aim is realistic whether you clearly understand the purpose of the agreement It is essential that both parties to an agreement think along the same lines. Agreement sits at the centre of every contract; if there is misunderstanding about what has been settled, or open...
Checklist Use this Checklist when preparing a confidentiality agreement (also called a non-disclosure agreement or NDA) in which you are the party sharing confidential information under that agreement. Before drafting, consider: what material the business intends to reveal and whether it is genuinely confidential; why the business plans to disclose that information; whether the business will also receive confidential information from the other party; and to whom the business will disclose that information. For further information, see Precedent: Ireland- Confidentiality agreement-mutual. Parties ☐ Confirm the parties to the agreement. Consider which individuals and/or entities should be party to the agreement. What information does the business want to disclose? ☐ Confirm how confidential information will be defined. Consider: whether a general definition or a list-based approach is appropriate; whether any confidential information belonging to group companies will be disclosed; whether any...
Evaluating a holding company jurisdiction This Checklist provides a practical template for assessing a prospective holding company jurisdiction from a tax standpoint and perspective. It should be carefully tailored to the specific deal at hand; to illustrate, rules on interest withholding are generally immaterial where no interest payments are anticipated in the circumstances. For a Practice Note that explains the general tax concerns, issues and aims summarised in this Checklist when selecting the location of a holding company or an intermediate holding vehicle for an international enterprise (or a segment of such an enterprise) or a fund, consult Practice Note: Holding company jurisdictions—tax considerations......
This Checklist This Checklist sets out the questions to address when you are looking to enforce a third party’s rights under a contract. The common law doctrine of privity of contract states that, as a general principle, an agreement cannot grant rights or impose duties created by its terms on anyone other than its parties, with the result that a person who is not a party ordinarily has no standing to enforce it. There are, however, situations in which a contract appears to bestow a benefit on a third party (or on several third parties), and those beneficiaries may wish to seek enforcement of that advantage. In such circumstances, attention should be given to the recognised exceptions to the privity rule-see Practice Note: Third party rights-the common law doctrine of privity of contract. One prominent exception is the ability to enforce third party rights by...
Appointment of new trustee What are the eligibility criteria? Trustees must be appointed in line with the charity’s governing document as well as the general law. Begin by reviewing the governing document, which may cap the number of trustees or stipulate age limits. Anyone under 18 cannot act as a trustee of an unincorporated association or a charitable trust. Individuals aged 16 or over may serve as company directors and, consequently, can be charity trustees of a charitable company......
The table below outlines various ways a company may return value to shareholders and provides a summary of the principal UK tax considerations applicable to each arrangement......
This Checklist sets out the principal time limits practitioners should note when lodging claims with the Workplace Relations Commission ( WRC). For fuller guidance on filing a WRC complaint, see Practice Note: Ireland- Making a complaint to the Workplace Relations Commission ( WRC)... Employment related claims Complaints arising under the Employment Equality Acts 1998–2015 ( Ireland) ( EEA 1998 ( IRL)) or the Pensions Acts 1990–2015 ( Ireland) ( PA 1990 ( IRL)) must be made by completing the online complaints form available on the WRC website. See the WRC website for further information on employment related claims... Type of claim: Employment related claims Time limit: Six months from the date of the alleged discrimination; where multiple alleged incidents occur, the relevant date is that of the most recent incident......
Preparatory steps Secure the employee’s most recent employment contract, together with any variations, related correspondence forming part of the contract, and any company handbook considered contractual Verify the employee’s continuous service particulars, including the employment start date and the dates of any contract amendments during employment Gather pension details: whether the scheme is defined benefit or defined contribution, and whether all employer contributions are fully up to date Identify the basis for the settlement-e.g., in respect of a Workplace Relations Commission ( WRC) claim, a redundancy payment, a personal injury claim, or another legal claim Where multiple claims are being resolved, ensure agreement with the employer on how the overall settlement is apportioned to each claim, and that both parties clearly understand the tax treatment of each amount Ascertain any shares or share option schemes held by the...
When drafting or negotiating third party rights provisions in a construction contract (see Practice Note: The Contracts ( Rights of Third Parties) Act 1999 in construction contracts), the following should be taken into account: Is the Contracts ( Rights of Third Parties) Act 1999 generally excluded? Does the agreement clearly exclude the conferral of rights or benefits on third parties under the Contracts ( Rights of Third Parties) Act 1999 ( C( RTP) A 1999)? Many contracts adopt a general exclusion of C( RTP) A 1999, but in construction arrangements this is usually qualified by any clause that grants specific third parties rights—see, for instance, Precedent: Third Party Rights Act clause. Where a general exclusion appears, ensure the clause granting rights to third parties is expressly carved out. Third party rights or collateral warranty? If the contract states that third party...
This checklist outlines the requirements an alternative investment fund manager ( AIFM) must include in its remuneration policy under the AIFM Remuneration Code (the Code) in the Financial Conduct Authority ( FCA) Handbook’s Senior Management Arrangements, Systems and Controls ( SYSC) sourcebook ( SYSC 19B), as well as the remuneration disclosures that belong in an alternative investment fund ( AIF)’s annual report. What is the AIFM Remuneration Code ( SYSC 19B)? The Code sits in SYSC 19B. It applies to a full-scope UK AIFM managing a UK AIF or a non- UK AIF. It covers pay and bonus for staff. It sets parameters for pay and bonus awards for specified Code staff. The Code comprises nine remuneration principles, set out in SYSC 19B.1.5 R to SYSC 19B.1.24 R. For guidance on each of these principles, see Practice Note: UK AIFMD—...
FORTHCOMING CHANGE relating to UK transfer pricing legislation Finance Bill 2026 (as introduced) outlines a suite of amendments to the UK’s transfer pricing framework. Once enacted, and applying to accounting periods starting on or after 1 January 2026, the package will, amongst other measures, switch off UK‑to‑ UK transfer pricing—subject to defined exclusions designed to prevent tax arbitrage—adjust the participation condition, confirm that the OECD Model Tax Convention and the OECD Transfer Pricing Guidelines function as interpretative aids, and recast aspects of the rules for financial transactions so that the UK approach is brought into closer alignment with the OECD Transfer Pricing Guidelines. In parallel, the government announced at Budget 2025 that it will move ahead with a new obligation for in‑scope multinational groups to report, each year, information on cross‑border related party dealings. This reporting applies for accounting periods beginning on or after 1...
Who is entitled to receive notice of general meeting or annual general meeting? Notice of a general meeting ( GM) or an annual general meeting ( AGM) must be given to: every member of the company, meaning those listed on the register of members (including anyone entitled to a share as a result of a member’s death or bankruptcy, where the company has been informed of that entitlement) each director of the company the company’s auditors Check the company’s articles in particular for provisions relating to: issuing notices to joint, untraceable or overseas shareholders cut-off dates by which a person must be entered on the register of members to receive a notice......
Repair under the common law Under the common law, a landlord, relative to a tenant, bears notably heavy duties regarding upkeep and repair of the leased premises, see Practice Note: Repair clauses in commercial leases in Scotland— Repair under the common law. Within commercial leasing, landlords will almost invariably aim to exclude all such common law repairing liabilities for the demised premises, though not for common areas in multi-let buildings; see Practice Note: Service charge and outgoing provisions in commercial leases in Scotland. Consequently, tenants usually shoulder substantial repair commitments. The prevalent model is the full repairing and insuring ( FRI) lease, under which the tenant assumes responsibility for repairs of every kind save for damage arising from insured risks; see Practice Note: Repair clauses in commercial leases in Scotland— Contracting out of the common law—the full repairing and insuring ( FRI) Lease and The...
Pre-emption period Ensure the agreement specifies a defined period during which the buyer enjoys the benefit of the right of pre-emption, with that entitlement confined to the stated timeframe. Trigger event Consider whether the event that obliges the seller to offer the property to the buyer (often captured by the definition of ‘ Disposal’) is drawn too broadly. For example, will granting a lease at a rack rent set off the pre-emption right? Many sellers regard such lettings as simple upkeep of their investment in the property. Also think about carving out from ‘ Disposal’ (or the pre-emption trigger) a contract for sale of the property that is conditional upon the right of pre-emption being exhausted. This can assist a landowner when concluding a sale with a third party, particularly where it is plain that the buyer has no intention of exercising the option. Avoid...
Trigger event Make sure the event that obliges the seller to offer the property to the buyer (often the defined term ‘ Disposal’) is drafted as broadly as possible. Think carefully about routes by which the seller might sidestep the pre-emption right, such as: disposing of only part; making a gift; or granting a long lease for a premium. The seller may want freedom to grant rack-rented leases to safeguard the investment in the property. Balance this against the buyer’s objectives. In a development setting, the buyer may not wish to spend time obtaining vacant possession and may therefore consider that even rack-rented leases should activate the seller’s offer. Steer clear of defining the trigger as arising when the seller ‘proposes to dispose’ of the property, as that wording can merely invite a disagreement about when that point in time...
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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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