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 This Checklist helps pinpoint typical recoverable historic financial outgoings and losses (special damages or historic pecuniary losses) arising before trial. It also aids in collating suitable evidence and highlights the questions that commonly emerge when valuing these losses, setting out recurring issues for consideration as appropriate in practice. For additional guidance, see: Past expenses and losses—overview......
Checklist This Checklist sets out the practical actions for creating, drafting and quality-checking a Participant Information Sheet ( PIS) for UK clinical research. It describes what the PIS is for and how it works, and gives hands-on advice on the essential components, addressing content and presentation alongside layout, format and style. The Checklist also explains how the PIS should meet obligations under UK data protection law, including the transparency duties in the United Kingdom General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR). It is suitable for any study involving human participants, with particular emphasis on clinical trials of investigational medicinal products ( CTIMPs). A clinical trial is a study in human subjects intended to identify or confirm the effects of an adverse reaction to a medicinal product. In the UK, such trials are governed by the Medicines for Human Use (...
This Checklist reviews acceptance and disclosure of Part 36 offers in split trial matters, drawing attention to extra considerations for the parties. It also addresses the costs consequences of putting forward a split liability only offer. For detailed guidance on Part 36 offers in split trial scenarios, see Practice Note: Part 36 offers—split trial cases. For further guidance on accepting a Part 36 offer more generally, see Practice Note: Part 36 offers—how and when to accept a Part 36 offer. Scenario Guidance Accepting a Part 36 offer that concerns only certain elements of the claim or specific issues to be resolved (eg accepting a Part 36 offer on liability alone where a trial on liability is to take place). A Part 36 offer limited to particular parts or issues within the claim cannot be accepted once the trial (in this instance, on...
This Checklist This Checklist outlines the main points to weigh up when preparing, reviewing or negotiating a parent company guarantee ( PCG) for an employer receiving one. While the terms ‘contractor’ and ‘employer’ are used, the same principles apply to a contractor–sub‑contractor arrangement or to an employer/contractor working with a consultant. As PCGs are commonly bespoke, the specific circumstances must always be assessed. Is the contractor obliged to deliver a PCG under the building contract? If not, there is no duty to supply one and provision will be a matter for negotiation. The contractor may still agree, to reassure the employer about its solvency and commitment to the project, and to create or preserve a constructive relationship with the employer. The employer should also confirm any specific timing for delivery of the PCG—for example, on contract signature, within a defined period after...
This checklist sets out the key issues to consider when reviewing a PCG on behalf of a contractor who is being asked to provide a PCG. The terms 'contractor' and 'employer' are used, but the same principles also extend to arrangements between a contractor and a sub-contractor, or between an employer/contractor and a consultant. As PCGs are commonly bespoke, the particular context should be taken into account when assessing a PCG. For a fuller discussion of these points, see Practice Note: Parent company guarantees ( PCGs) in construction—drafting and negotiation issues. Is the contractor obliged under the Building Contract to provide a PCG? If not, there is no requirement for the contractor to deliver one. Nevertheless, a contractor might still agree to give a PCG to reassure the employer and to create or sustain a good working...
ARCHIVED: This archived checklist explains the required format of a paper bill of costs for detailed assessment. It outlines the various components of the bill of costs, specifies the information that must be included, and provides the relevant CPR PD 47 references alongside guidance notes. It covers bills of costs under CPR 47 and CPR PD 47 and the paper Precedents A, B, C, D, E and F. Note that costs incurred from 6 April 2018 must be presented in an electronic bill of costs. It is not maintained and is supplied for background information only. For further details, see Practice Note: Detailed assessment—bill of costs......
This Checklist is intended for in-house lawyers. It outlines the clauses to weigh up to safeguard your organisation in both current and future contracts should a pandemic arise. Read it alongside Practice Note: Pandemic risk management guide. See also Practice Note: Drafting for unforeseen events—commercial contracts. Force majeure Clause: Existing contract | New contract See Q& As: Will our force majeure provision cover the economic impact of coronavirus ( COVID-19)? Is a force majeure clause enforceable in a business-to-consumer agreement due to coronavirus ( COVID-19)? Does coronavirus ( COVID-19) amount to biological contamination for the purposes of a force majeure definition? Is the force majeure definition restricted to a fixed list of events, without broader wording such as ‘without limitation’ or similar? Where a force majeure event is described as beyond a party’s reasonable control, ‘including but not limited to’...
ARCHIVED This Practice Note has been archived and is no longer being maintained or updated, and will not be maintained further. This timeline sets out both the regulatory activity leading up to the adoption of a legislative proposal for the regulation and the later developments relating to Regulation 1286/2014/ EU on Key Information Documents ( KIDs) for packaged retail and insurance-based investment products ( PRIIPs) ( EU PRIIPs Regulation), together with the onshored UK counterpart ( Retained Regulation 1286/2014/ EU, UK PRIIPs Regulation). The EU and UK PRIIPs regimes establish harmonised rules for the format and content of KIDs produced by PRIIPs manufacturers, and for providing those KIDs to retail investors in order that they can understand the principal features and risks of PRIIPs. A detailed regulatory framework has been developed to tackle the risks, gaps and inconsistencies encountered when seeking to ensure investor...
More staff and freelancers are now working from home on a regular basis. Consequently, more material is produced at home and uploaded or circulated online—for instance, teachers sharing with their pupils via video platforms. Where content is made in this setting, consider who owns the IP, any use of third‑party works, and potential breaches of third‑party rights. For more detail on matters raised by this Checklist, consult the following Practice Notes: Copyright—protectable works Copyright—authorship and ownership Copyright & associated rights—overview Copyright infringement Copyright—secondary infringement Intellectual property—remedies Copyright—permitted acts and defences Joint ownership of intellectual property rights Use the third column to note observations or remarks while progressing through the Checklist. Checklist | Further information | Notes (if any) Copyright origination ☐ Pinpoint the copyright work. Copyright is unregistered and arises automatically once a qualifying work is created......
This checklist outlines the initial points to assess whether an overseas company must register in the UK, together with the actions needed to complete that registration. The framework for registering an overseas company trading in the UK is clearly separate and distinct from the regime for registering overseas entities that hold an interest in UK property. Item to be reviewed or action to be taken Reference to the relevant provision of the Companies Act 2006 ( CA 2006) and/or other legislation Tick box once the action is completed or the point considered Preliminary considerations Has the overseas company set up an 'establishment' in the UK?......
Checklist No dedicated legislation, including tax legislation, governs outsourcing, and the expression has no precise legal definition. Accordingly, each outsourcing arrangement is determined by its own circumstances and will produce a different combination of tax considerations. This Checklist identifies the headline tax points that ought to be assessed in relation to a contractual outsourcing. For the purposes of this Checklist, it is assumed that: the arrangement comprises a direct supply of services by a third-party service provider to a customer both the supplier and the customer are corporate bodies, and both the supplier and the customer are resident in the UK, save for the final section on cross-border tax issues The Checklist is organised into the following three sections: establishing outsourcing arrangements running outsourcing arrangements, and cross-border outsourcing arrangements This Checklist should be read together with the following Practice Notes: ...
This checklist supports an organisation with the due diligence and risk assessment vital to the effective selection of outsourcing service providers. Refer also to: Outsourcing supplier interview questions—checklist and Outsourcing supplier interview questions (finalist supplier selection)—checklist. Question Yes/ No Comments Does the appraisal of the proposed supplier address some, if not all, of the following: Experience in delivering and supporting the proposed activity? [ Yes/ No] [comment] Audited financial statements for the supplier and its key affiliates? [ Yes/ No] [comment] Business reputation, complaints, and any litigation? [ Yes/ No] [comment] ......
This checklist provides interview questions for the evaluation of finalists in the selection of an outsourcing supplier The checklist can be customised to suit the client’s sector and the characteristics of the finalist suppliers, as appropriate. See also: Outsourcing supplier interview questions—checklist and Outsourcing supplier selection and due diligence—checklist. When interviewing shortlisted providers during selection, consider the following questions. Ensure the same core questions are asked of each supplier in order to allow consistent comparison of responses: In what specific ways does your approach differ from other suppliers?......
This checklist provides interview questions for the evaluation of outsourcing suppliers Use this checklist as a set of interview prompts to assess outsourcing providers. The questions are general in nature and should be adapted to the client’s industry and the specific outsourcing services required. See further: Outsourcing supplier interview questions (finalist supplier selection)—checklist and Outsourcing supplier selection and due diligence—checklist. How would you characterise your current financial results? What future forecasts have you prepared? Which sales methodologies or processes do you use? At what pace does your company intend to grow?......
Checklist This Checklist outlines essential compliance steps for law firms undertaking outsourcing, beginning when your firm initially contemplates entering an outsourcing agreement and continuing through to, and encompassing, all the post-agreement audit activities......
Financial services and data protection regulatory regimes Financial services firms must ensure their outsourcing arrangements align with the outsourcing obligations of two distinct regulatory frameworks: the financial services regulatory regime, mainly comprising: Commission Assimilated Retained Regulation ( EU) 2017/565 (the UK Mi FID II Organisational Regulation) the Senior Management Arrangements, Systems and Controls sourcebook ( SYSC) in the Financial Conduct Authority ( FCA) Handbook the Outsourcing Part of the Prudential Regulation Authority ( PRA) Rulebook the data protection regulatory regime, centred on the onshored General Data Protection Regulation, Assimilated Regulation ( EU) 2016/679 ( UK GDPR) The Checklist delivers high-level guidance on the outsourcing expectations under both regimes and acts as an initial step towards creating a unified...
ARCHIVED : This archived table sets out details of the renumbered provisions in the Taxation of Chargeable Gains Act 1992 (‘the Act’), arising from the redrafting of Part 1 of the Act by the Finance Act 2019. From 6 April 2019, Part 1 of the Taxation of Chargeable Gains Act 1992 ( TCGA 1992) was recast. The revised TCGA 1992, Pt 1 was brought in by section 13 and Schedule 1 of the Finance Act 2019, with the principal objective of bringing disposals of UK non-residential property by non- UK residents within scope of UK tax, so that disposals of both residential and non-residential UK property on or after 6 April 2019, subject to specified exemptions, fall within capital gains tax ( CGT) or corporation tax on chargeable gains. The consequence is that UK residents and non-residents are equally within charge on...
These tables have been archived and is not maintained. The tables set out the following: the specific locations in TIOPA 2010, Part 9A for the former corporation tax assumptions; and the new assumptions within TIOPA 2010, Part 9A that do not derive entirely from the old rules The new assumptions are further explained in: CFC rules—the corporation tax assumptions......
This Checklist sets out three principal tables: Matters designated as ordinary resolutions under the CA 2006 Resolutions that are commonly approved as ordinary resolutions Ordinary resolutions that must be filed with Companies House Ordinary resolutions The Companies Act 2006 ( CA 2006) identifies specific matters that must be decided by ordinary resolution (that is, a simple majority) of a company’s members, for example the removal of a director. CA 2006 also sets out matters that must be achieved by special resolution of the company, or where a 75% threshold applies. Where CA 2006 requires that something is to be done by passing a resolution but does not state the category of resolution, an ordinary resolution will be sufficient, unless the articles of association require a greater majority or unanimity......
For further information relating to each of these stages, see the following Practice Notes: Case oversight in the magistrates’ courts The course of a criminal matter Phases of a summary hearing Burden and level of proof in criminal cases Ability and compellability of witnesses in criminal cases Witness testimony during a criminal trial Special arrangements Expert testimony in criminal proceedings Admitting a defendant’s bad character in criminal proceedings Admissibility of hearsay evidence in criminal proceedings Penalties imposed after conviction Obligation to give reasons and set out the effect of sentence imposed......
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 ]...