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
This checklist identifies the principal points to bear in mind when preparing or assessing a pre-construction services agreement ( PCSA). Remember that the content and scope of any PCSA will hinge on the services the contractor is to deliver and the expected length of the pre-construction phase. Consequently, the drafting may differ significantly. For further detail on PCSAs, see Practice Note: Pre-construction services agreements. PCSAs generally draw together aspects from several sources. Core terms are akin to those used in a letter of intent, but with added provisions to address liaising with other parties and preliminary works taking place on site. By contrast with a letter of intent, a PCSA is set out as a conventional legal agreement, with distinct sections for the parties and for recitals. A letter of intent A consultant’s appointment A building...
Signing The initial major milestone on the path to completing a loan transaction is 'signing'. Signing denotes the moment the parties execute the agreed forms of the documents and the bargain becomes binding (though, in many cases, this remains subject to conditions precedent being fulfilled). For more information, see Practice Notes: How to arrange execution of the finance documents in a loan transaction and Signing and completion phase in loan transactions. After signing, the parties move to satisfying the conditions precedent to funding. For more information, see Practice Notes: Conditions precedent and Conditions precedent phase in loan transactions. Once the conditions precedent have been met, the lender’s solicitors undertake final pre-completion searches prior to funding. For more information, see Practice Note: How to conduct pre-completion searches in loan transactions. At completion loan monies are transferred between the parties and the...
Checklist Case review: facts, both sides’ legal positions, award enforceability, commercial drivers, and desired outcome. One-page argument summary (diagrams if helpful); if it resists distillation, investigate further. Project plan: routes to objectives, issues, stakeholders, evidence and data handling, initial timetable for claim/defence and later steps, indicative timings, responsibilities, and timing risks. Update the summary and plan throughout. Use them to stay on track, build a staged budget and funding needs, and maintain a document/correspondence tracker. Communications plan: group email or shared repository, cybersecurity/data protection, privilege with the client (esp multiple clients), protocols with tribunal/opponent (incl co-counsel), external notices (eg market), and a retrievable filing system. Evidence plan: locate documents/witnesses, pause destruction policies, collect and code material in a searchable, access-controlled database, schedule witness interviews, and address...
ARCHIVED: This checklist is kept for historical reference only. It sets out Part 36 of the CPR as it applied before 6 April 2015. Where you have received a Part 36 offer on or from 6 April 2015, you should consult CPR 36 in force and our Practice Notes, Checklists and Precedents dealing with this, see: Part 36 offers—overview. If you are in receipt of a Part 36 offer that pre-dates 6 April 2015, then the version of the Part 36 rules that was in force before that date applies......
ARCHIVED: This Checklist is for historical reference only. It summarises CPR Part 36 as it stood before 6 April 2015. If you have been served with a Part 36 offer on or after 6 April 2015, you must consult the CPR 36 currently in force and our accompanying Practice Notes, Checklists and Precedents on this topic; see: Part 36 offers—overview. Where a Part 36 offer was received before 6 April 2015, the version of the Part 36 rules that applied up to that date governs. Those earlier provisions remain applicable......
Practical tips for practitioners : Treat the date of knowledge as the earliest conceivable point and proceed on that basis until you are wholly satisfied that a later date can properly be applied. If any limitation concerns arise, examine them straightaway at the outset of the matter. Do not rely solely on the claimant’s account of the knowledge date or when the cause of action accrued; corroboration, especially through medical records, is vital. Protect your client’s position. If instructions arrive when limitation is close to expiry, either issue protective court proceedings or obtain an agreed extension from the defendant’s solicitors or insurers to allow more time to investigate the claim’s merits......
This Checklist This Checklist sets out essential, hands-on advice for criminal practitioners who need to take part in hearings held via live audio or live video links. Read it alongside the Practice Note: Practical guide to remote hearings in the criminal courts, which contains fuller step-by-step assistance on, for example, preparation in advance, technology considerations, and participation in the hearing itself through platforms including the dedicated Cloud Video Platform ( CVP) and the Video Hearings Service ( VHS). Be aware that VHS is not yet fully rolled out across England and Wales. It was withdrawn from service in July 2024 to resolve stability problems, and HM Courts and Tribunal Service ( HMCTS) has stated it plans to reinstate it after completing a scheduled handover to a new service provider. When back in use, local courts will notify users of the start of VHS...
FORTHCOMING CHANGE: A consultation, which ended on 7 July 2025, invited feedback on ways to streamline, update and reshape HMRC’s approach to dispute resolution, with the goal of boosting awareness of the existing procedures and widening access to (and participation in) alternative dispute resolution ( ADR) and statutory review routes. It further suggests adopting a clearer, harmonised appeals framework that draws together the strengths of the different models currently operating for both direct and indirect tax disputes. For additional detail, see the News Analysis pieces: Tax update spring 2025— Tax analysis— Taxes management and dispute resolution and Tax update spring 2025— Improving HMRC’s approach to dispute resolution. This Checklist was prepared and authored by Anne Redston, Barrister. It represents her personal opinion; she is not authorised to speak for the Tribunals Service or the judiciary. Receipt of an HMRC decision usually triggers the...
This Checklist outlines the practical considerations for a franchisor when launching an international franchise. A franchisor may wish to grow its network abroad to tap new territories and emerging markets, usually by entering into an international franchise agreement or an international development agreement. Nevertheless, the agreement and the structuring of the international arrangement can also present challenges and complications. This Checklist identifies some of the practical issues that a franchisor planning to expand overseas might encounter. Issues The franchise agreement will state that the franchisee must run the business in line with the franchisor’s operations manual. However, the business method described in that manual may not have been piloted or proven in the overseas territory. It will have been devised on assumptions tailored to the local market. A franchisee may therefore struggle to implement the method in the overseas territory if reliant on those...
ARCHIVED: This Practice Note has been archived and is no longer being maintained This tracker summarises the consultation papers issued by the Prudential Regulation Authority ( PRA) from 2017 onwards, together with the release of any follow‑on rules and guidance. For material on consultation papers from the Financial Conduct Authority ( FCA) and the Financial Services Authority ( FSA), see: FCA consultation paper tracker FSA consultation paper tracker Topic area, consultation paper, description, publication date, end of consultation period, and any Policy Statement / Supervisory Statement are recorded. Regulation of insurance 2023 — CP24/23 – Funded reinsurance. This consultation paper outlines proposed expectations for life insurance firms acting as cedants when entering into, or retaining, funded reinsurance arrangements. The PRA’s proposals reflect its assessment that the rising use of funded reinsurance within the UK insurance market presents significant potential risks, including the prospect of unduly...
Power purchase agreements ( PPAs), and the consequent checklist considerations, will differ according to several elements, such as the generation technology adopted and, notably, whether any feedstock or fuel is necessary to run the finished plant. The nature of the deal—be it a short-term trading arrangement or a longer-term contract required to support financing—will likewise be influential. This Checklist proceeds on the basis of a ‘conventional’ PPA with a licensed supplier as the counterparty. Other forms exist, including corporate PPAs where the buyer is an end user, potentially linked to the plant by a private wire. For additional detail on corporate PPAs, see Practice Note: Corporate Power Purchase Agreements—an introduction to structuring power purchase arrangements between large energy users and remotely located generators. What is/check the duration of the agreement? Where a PPA is needed to underpin external financing for a new...
This checklist outlines, in brief, the principal tasks and responsibilities that will usually fall to the buyer’s lawyers (and, in some instances, the seller’s lawyers) after completion of a private M& A acquisition where the target is a company incorporated in England & Wales. Once completion has occurred, the SPA should be reviewed carefully so the parties’ lawyers can accurately diarise the agreed matters, especially any deadlines, by reference to the parties’ specific post-completion obligations. As a result, although this checklist points to actions that are commonly required, every deal is different and the list cannot be comprehensive... Issue Guidance Registration of share transfers Buyer’s lawyers: Lodge with the Stamp Office the stock transfer form(s) (or a declaration of trust—see note below) relating to the target’s shares, for adjudication and payment of any stamp duty/transfer taxes (within 30 days of...
At completion At completion, funds are transferred between the parties and the deal is treated as completed. For a straightforward corporate facility, this typically involves a movement of monies from the lender to the borrower. In other financing structures, such as acquisition or asset finance, monies will ordinarily pass from the lender(s) to the borrower or to an existing lender (where its loan is being refinanced) and then from the borrower, acting as purchaser, to the seller of the business or asset. Following completion, the lender’s solicitors must address several legal and practical tasks. This checklist sets out the principal items for the lender’s lawyers to handle post-completion, including: perfecting security addressing any conditions subsequent complying with solicitors’ undertakings managing the original documents and compiling transaction bundles, and billing the client These matters are pertinent to most...
In a share sale, the purchaser acquires control of the company that operates the business (the target), along with all its assets, and by default steps into all of its obligations and both known and potential liabilities. Findings in legal due diligence and the share purchase agreement can identify particular environmental, health & safety ( EHS) matters to be addressed after completion. These may range from an obligation to commission an environmental audit through to the preparation of an asbestos management plan......
Under an asset purchase, the purchaser takes only the selected assets and assumes only the specific liabilities it opts to accept, as detailed in the asset purchase agreement. After completion, issues highlighted by due diligence may require the purchaser to address environmental, health and safety ( EHS) matters. For example, the purchaser might need to transfer or apply for a permit, join a recognised packaging waste compliance scheme, or strengthen health & safety documentation following completion. Typical post-completion EHS actions in asset purchase transactions include the following: transferring environmental permits verifying whether the deal triggers any new duties under environmental regimes, such as producer responsibility, energy efficiency and carbon schemes tackling points raised in environmental audits and reports, and any contractual conditions advising on the scope of environmental insurance and other risk-mitigation strategies putting in place reliance agreements or collateral warranties to allow reliance on...
What is a positive covenant? A covenant operates as a contractual promise. Common examples of positive covenants found in land transfers impose duties to: carry out repairs or upkeep (for example, access ways), or contribute towards repair and maintenance expenses incurred by another put up buildings or boundary fencing (for example, on a transfer of part) pay additional sums (i.e. overage) where, for instance, planning permission is obtained, or on a sale following development of the land What is the issue with positive covenants? At common law, it is firmly settled that the burden of a positive covenant affecting freehold land does not pass with the estate. Accordingly, if one party to a freehold transfer ( Party B) gives a positive covenant in favour of the other ( Party A), that obligation will not bind Party B's successors in title, despite section 79 of the Law of...
The requirement for planning use swaps can emerge when a planning proposal would diminish residential floor space and the local planning authority ( LPA) insists that a linked application is lodged to secure a proportionate re-provision of residential space in a different location. This is ordinarily pursued to ensure an equivalent level of residential provision is secured elsewhere through a connected scheme. Frequently, two distinct developers are engaged in a use swap. One applicant seeks consent for works or a change of use that results in the loss of dwellings ( Developer A), whilst another brings forward a connected application to deliver residential accommodation in another part of the area ( Developer B). A planning use swap agreement records the basis on which the swap proceeds. For further details, see Practice Note: Planning use swaps. Does the planning use swap agreement include the relevant...
How are section 278 and section 38 agreements revealed? Check the outcome of the local search and the seller’s replies to enquiries. A section 278 agreement will only be registrable as local land charges if: it has been entered into pursuant to an obligation in a s 106 agreement; or the highway authority ( HA) has declared that there has been a financial default under the agreement. Section 278 agreements Section 278 agreements are used where a developer requires off-site work (other than simple access) to be carried out to a highway. The HA may design and construct the highway works at the developer’s expense. Alternatively, the agreement can appoint the developer as the HA’s agent to undertake the works, in which case a bond must support the agreement. If the developer carries out the works, a certificate of practical completion is issued once the HA...
Importance of establishing the planning history of a site Where a deal involves creating, acquiring or disposing of any interest in land, confirming whether existing or intended uses or any operational works on that land are lawful is essential. This is because permission for the ‘development’ of land, as defined by section 55 of the Town and Country Planning Act 1990 ( TCPA 1990) (see Overview: Is planning permission required?), must be in place unless the works or uses are allowed by a development order, for example the Town and Country Planning ( General Permitted Development) Order 2015, SI 2015/596 (for England) or the Town and Country Planning ( General Permitted Development) Order 1995, SI 1995/418 (for Wales) (see: Permitted development—overview). Failure to obtain planning permission when the law requires it, or failure to comply with conditions attached to a...
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 ]...